JP2021509315A - Control of ultrasonic surgical instruments according to tissue position - Google Patents

Abstract

Various systems and methods for controlling ultrasonic surgical instruments according to the position of the tissue gripped within the end effector (1122) are disclosed. The control circuit can be configured via a generator to apply various power levels to the ultrasonic transducer to drive the ultrasonic electromechanical system and vibrate the ultrasonic blades. In addition, the control circuit measures the impedance of the ultrasonic transducers for different power levels and the position of the tissue positioned within the end effector according to the difference between the impedances of the ultrasonic transducers with respect to the threshold (130420, 130424, 130422) can be determined.

Description

(Cross-reference of related applications)
This application is filed August 23, 2018, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION," the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the United States Patent Act. Claims priority over US Patent Provisional Application No. 62 / 721,995.

This application is a provisional U.S. patent filed on August 23, 2018, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the U.S. Patent Act. Claim priority over Application No. 62 / 721,998.

This application is filed on August 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the United States Patent Act. Claims priority over US Patent Provisional Application No. 62 / 721,999.

This application is entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESS PRESS ON ENERGY MODALITY", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the United States Patent Act. Claims priority over US Patent Provisional Application No. 62 / 721,994 of the Japanese application.

This application is filed August 23, 2018, entitled "RADIO FREENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRIC SIGNAL SIGNALS", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the United States Patent Act. Claims priority over US Patent Provisional Application No. 62 / 721,996.

This application is further entitled "SMART ACTIVE OF AN ENERGY DEVICE BY ANOTHER DEVICE", which is incorporated herein by reference in its entirety under Article 119 (e) of the United States Patent Act, June 30, 2018. US Patent Provisional Application No. 62 / 692,747 filed in Japan, US Patent Provisional Application No. 62 / 692,748, filed June 30, 2018, entitled "SMART ENERGY ARCHITECTURE", and "SMART ENERGY DEVICES" Claims priority over US Patent Provisional Application No. 62 / 692,768 filed June 30, 2018.

This application is further under Article 119 (e) of the United States Patent Act, entitled "CAPATICIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", the entire disclosure of which is incorporated herein by reference. US Patent Provisional Application No. 62 / 650,898 filed in Japan, US Patent Provisional Application No. 62 / 650,887 filed on March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", "SMOKE EVACUATION MOD" U.S. Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "INTERACTIVE SURGICAL PLATFORM," and U.S. Patent, March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTORLS." Claim the interests of the priority of 62 / 650,877.

This application is also a provisional US patent filed on December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," in which the entire disclosure is incorporated herein by reference under Section 119 (e) of the US Patent Act. Application No. 62 / 611,341, US Patent Provisional Application No. 62 / 611,340, filed December 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS", and December 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM". Claims the priority benefit of US Patent Provisional Application No. 62 / 611,339 filed on 28th May.

Surgical environments may require smart energy devices within a smart energy architecture environment.

A general aspect is a method of locating tissue located within an end effector of an ultrasonic surgical instrument equipped with an ultrasonic converter, the end effector being acoustically coupled to the ultrasonic converter. A method with an ultrasonic blade. The method is to apply the first power level to the ultrasonic converter by the control circuit, and to measure the first impedance measurement value of the ultrasonic converter corresponding to the first power level by the control circuit. The control circuit applies a second power level to the ultrasonic converter, and the control circuit measures the second impedance measurement value of the ultrasonic converter corresponding to the second power level. The control circuit calculates the difference in the impedance of the ultrasonic converter between the first impedance measurement value and the second impedance measurement value, and the control circuit calculates the difference in the impedance of the ultrasonic converter. It includes comparing with a threshold and determining the position of the tissue positioned within the end effector based on the first threshold by the control circuit.

In another general aspect, an ultrasonic surgical instrument that can be connected to a generator. The ultrasonic surgical instrument includes an end effector including an ultrasonic blade, an ultrasonic converter acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic converter. The ultrasonic converter is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from the generator. The control circuit applies various power levels to the ultrasonic converter via the ultrasonic generator, measures the impedance of the ultrasonic converter corresponding to the various power levels, and between the impedances of the ultrasonic converter with respect to the threshold. It is configured to determine the position of the tissue located within the end effector according to the difference between the two.

In another general aspect, an ultrasonic generator that can be connected to an ultrasonic instrument, comprising an end effector, an ultrasonic blade, and an ultrasonic converter acoustically coupled to the ultrasonic blade. .. The ultrasonic generator includes a control circuit that can be coupled to the ultrasonic converter. The control circuit applies various power levels to the ultrasonic transducer, measures the impedance of the ultrasonic transducer corresponding to the various power levels, and in the end effector according to the difference between the impedance of the ultrasonic converter with respect to the threshold. It is configured to determine the location of the tissue located in.

The features of the various aspects are described in detail within the appended claims. However, various aspects of both the mechanism and the method of operation, along with their further objectives and advantages, can be best understood by reference to the following description, in conjunction with the accompanying drawings below.
FIG. 6 is a block diagram of a computer-mounted interactive surgical system according to at least one aspect of the present disclosure. A surgical system used to perform a surgical procedure in an operating room according to at least one aspect of the present disclosure. A surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. FIG. 3 is a partial perspective view of a surgical hub housing and a combination generator module slidably acceptable within the drawer of the surgical hub housing according to at least one aspect of the present disclosure. FIG. 3 is a perspective view of a combination generator module with bipolar, ultrasonic, and unipolar contacts, and smoke exhaust components, according to at least one aspect of the present disclosure. Demonstrates the individual power bus attachments of a plurality of lateral docking ports of a laterally modular housing configured to accept a plurality of modules according to at least one aspect of the present disclosure. Demonstrates a vertically modular housing configured to accept multiple modules according to at least one aspect of the present disclosure. A modular device located in one or more operating rooms of a medical facility, or any room in a medical facility equipped with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure. Shown is a surgical data network with a modular communication hub configured to connect. A computer-mounted interactive surgical system according to at least one aspect of the present disclosure is shown. Demonstrates a surgical hub with a plurality of modules coupled to a modular control tower according to at least one aspect of the present disclosure. Shows one aspect of a universal serial bus (USB) network hub device according to at least one aspect of the present disclosure. A logical diagram of a control system for a surgical instrument or tool according to at least one aspect of the present disclosure is shown. Demonstrates a control circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates a combination logic circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates an order logic circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. It is a circuit diagram of a robotic surgical instrument configured to operate the surgical tools described herein according to at least one aspect of the present disclosure. FIG. 3 shows a block diagram of a surgical instrument programmed to control the distal translation of a displacement member according to at least one aspect of the present disclosure. It is a circuit diagram of a surgical instrument configured to control various functions according to at least one aspect of the present disclosure. A system configured to perform an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub according to at least one aspect of the present disclosure. An embodiment of a generator according to at least one aspect of the present disclosure is shown. A surgical system comprising a generator and various surgical instruments that can be used with the generator according to at least one aspect of the present disclosure. An end effector according to at least one aspect of the present disclosure. FIG. 2 is a diagram of the surgical system of FIG. 22 according to at least one aspect of the present disclosure. It is a model showing an operating branch current according to at least one aspect of the present disclosure. It is a structural diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a functional diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a functional diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a functional diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a structural and functional aspect of the generator according to at least one aspect of the present disclosure. It is a structural and functional aspect of the generator according to at least one aspect of the present disclosure. It is a circuit diagram of one aspect of an ultrasonic drive circuit. It is a circuit diagram of the control circuit according to at least one aspect of this disclosure. Shown is a simplified block schematic illustrating another electrical circuit housed within a modular ultrasonic surgical instrument according to at least one aspect of the present disclosure. A generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure is shown. Shown is a generator circuit divided into a plurality of stages in which the first stage circuit is common to the second stage circuit according to at least one aspect of the present disclosure. It is a circuit diagram of one aspect of a drive circuit configured to drive a radio frequency current (RF) according to at least one aspect of the present disclosure. A digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms of electrical signal waveforms for use in surgical instruments, according to at least one aspect of the present disclosure. Shows one aspect of the basic architecture. Shown is an aspect of a direct digital compositing (DDS) circuit configured to generate multiple waveforms of electrical signal waveforms for use in surgical instruments, according to at least one aspect of the present disclosure. One cycle of a discrete-time digital electrical signal waveform according to at least one aspect of the present disclosure of an analog waveform (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure. Shown. Control according to one aspect of the present disclosure to provide gradual closure of the closing member as the closing member advances distally to close the clamp arm and apply a closing force load at a desired speed. It is a diagram of the system. A proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure is shown. FIG. 5 is a system diagram of a segmented circuit comprising a plurality of independently operating circuit segments according to at least one aspect of the present disclosure. It is a circuit diagram of various components of a surgical instrument having a motor control function according to at least one aspect of the present disclosure. An alternative system for controlling the frequency of an ultrasonic electromechanical system and detecting its impedance, according to at least one aspect of the present disclosure. FIG. 5 is a graph representation of the impedance phase angle as a function of the resonance frequency of the same ultrasonic device with low temperature (blue) and high temperature (red) ultrasonic blades. It is a graph display of the magnitude of impedance as a function of the resonance frequency of the same ultrasonic device equipped with low temperature (blue) and high temperature (red) ultrasonic blades. FIG. 5 is a Kalman filter diagram that improves the temperature estimator and state space model based on impedance across ultrasonic transducers measured at various frequencies according to at least one aspect of the present disclosure. Three probability distributions adopted by the Kalman filter state estimator shown in FIG. 44 to maximize estimation according to at least one aspect of the present disclosure. 6 is a graph representation of the temperature vs. time of an ultrasonic device that does not have temperature control to reach a maximum temperature of 490 ° C. FIG. 6 is a graph representation of the temperature vs. time of an ultrasonic device having temperature control to reach a maximum temperature of 320 ° C. according to at least one aspect of the present disclosure. It is a graph display of feedback control for adjusting the ultrasonic output applied to the ultrasonic converter when a sudden temperature drop of the ultrasonic blade is detected, and it is a graph display of the ultrasonic output as a function of time. is there. It is a graph display of feedback control for adjusting the ultrasonic output applied to the ultrasonic converter when a sudden temperature drop of the ultrasonic blade is detected, and is a function of time according to at least one aspect of the present disclosure. It is a plot of the ultrasonic blade temperature as. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for controlling the temperature of an ultrasonic blade according to at least one aspect of the present disclosure. FIG. 5 is a graph representation of ultrasonic blade temperature as a function of time during vessel firing, according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for controlling the temperature of an ultrasonic blade between two temperature set values according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for determining the initial temperature of an ultrasonic blade according to at least one aspect of the present disclosure. According to at least one aspect of the present disclosure, for determining when the ultrasonic blade is approaching instability, and subsequently adjusting the power to the ultrasonic converter to prevent the instability of the ultrasonic converter. It is a logical flow diagram of a process which shows a control program or a logical structure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for providing ultrasonic encapsulation with temperature control according to at least one aspect of the present disclosure. FIG. 5 is a graph representation of ultrasonic transducer current and ultrasonic blade temperature as a function of time, according to at least one aspect of the present disclosure. FIG. 5 is a bottom view of an ultrasonic end effector showing a clamp arm and an ultrasonic blade depicting the positioning of tissue within the ultrasonic end effector according to at least one aspect of the present disclosure. FIG. 6 is a graph showing changes in ultrasonic transducer impedance as a function of tissue position within an ultrasonic end effector over a range of increasing predetermined ultrasonic generator power levels, according to at least one aspect of the present disclosure. FIG. 6 is a graph showing the change in ultrasonic converter impedance as a function of time with respect to the position of tissue within the ultrasonic end effector according to at least one aspect of the present disclosure. In a logical flow diagram of a process showing a control program or logical configuration for identifying operation in a non-therapeutic range of power applied to an ultrasonic transducer to determine tissue positioning, according to at least one aspect of the present disclosure. is there. Shown is an aspect of an end effector of an ultrasonic surgical instrument having an infrared (IR) sensor located on a jaw member according to at least one aspect of the present disclosure. According to one aspect of the present disclosure, the IR sensor shown in FIG. 59 shows one aspect of a flexible circuit that can be integrally attached or formed. FIG. 5 is a cross-sectional view of an ultrasonic end effector including a clamp arm and an ultrasonic blade according to at least one aspect of the present disclosure. An IR refraction detection sensor circuit mounted on a flexible circuit board shown in plan view according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for measuring IR reflectance to determine tissue composition and adjusting amplitude of an ultrasonic converter according to at least one aspect of the present disclosure. For identifying collagen metamorphosis points according to various aspects of the present disclosure, according to at least one aspect of the present disclosure, time is shown along the horizontal axis and changes in clamp arm position are shown along the vertical axis. It is a graph display of the closing rate vs. time of the clamp arm. It is an enlarged part of the graph display shown in FIG. 64A. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for detecting a collagen transformation point and controlling the clamp arm closure rate or the amplitude of an ultrasonic converter according to at least one aspect of the present disclosure. To identify the collagen / elastin ratio according to the various aspects of the present disclosure, according to at least one aspect of the present disclosure, the tissue temperature is shown along the horizontal axis and the ultrasonic converter impedance is shown along the vertical axis. It is a graph display of identification of the collagen transformation temperature point of. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for identifying a collagen transformation temperature to identify a collagen / elastin ratio according to at least one aspect of the present disclosure. FIG. 5 is a graph representation of the distribution of compression loads across ultrasonic blades according to at least one aspect of the present disclosure. FIG. 6 is a graphical representation of pressure vs. time applied to tissue according to at least one aspect of the present disclosure. An end effector comprising a single jaw electrode array for detecting tissue location is shown according to at least one aspect of the present disclosure. It is an activation matrix of the single jaw electrode array of FIG. 70 according to at least one aspect of the present disclosure. An end effector comprising a dual jaw electrode array for detecting tissue position is shown according to at least one aspect of the present disclosure. It is an activation matrix of the dual jaw electrode array of FIG. 72 according to at least one aspect of the present disclosure. An opposite set of electrodes superimposed on a tissue gripped by an end effector corresponding to the activation matrix of FIG. 73 according to at least one aspect of the present disclosure is shown. An end effector comprising a dual jaw segmented electrode array according to at least one aspect of the present disclosure is shown. A structure superimposed on a jaw containing a segmented electrode array according to at least one aspect of the present disclosure is shown. FIG. 3 is a circuit diagram of a segmented electrode array circuit including a bandpass filter according to at least one aspect of the present disclosure. FIG. 76 is a graphical representation of the frequency response corresponding to the tissue gripped in FIG. 76, according to at least one aspect of the present disclosure. FIG. 6 is a graph representation of the frequency of an ultrasonic converter system as a function of drive frequency and ultrasonic blade temperature drift, according to at least one aspect of the present disclosure. FIG. 6 is a graph representation of the temperature of an ultrasonic transducer as a function of time, according to at least one aspect of the present disclosure. It is a graph representation of the modal shift of the resonance frequency based on the temperature of the ultrasonic blade which moves the resonance frequency as a function of the temperature of the ultrasonic blade by at least one aspect of this disclosure. It is a spectrum of an ultrasonic surgical instrument having various different states and conditions of an end effector, in which the phase and magnitude of the impedance of the ultrasonic converter are plotted as a function of frequency according to at least one aspect of the present disclosure. .. A methodology for classifying data based on a set of training data S according to at least one aspect of the present disclosure, where the magnitude and phase of the ultrasonic transducer impedance are plotted as a function of frequency. FIG. 5 is a logical flow diagram showing a control program or logical configuration for determining a jaw state based on a complex impedance characteristic pattern (fingerprint) according to at least one aspect of the present disclosure. It is a timeline showing the situational awareness of the surgical hub according to at least one aspect of the present disclosure.

The applicant of the present application owns the following US patent application filed on August 28, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application Reference No. END8536USNP2 / 180107-2, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THE REFOR",
-US Patent Application Reference Number END8560USNP2 / 180106-2, entitled "TEMPERATURE CONTORO OF ULTRASONIC END EFFECTOR AND CONTORL SYSTEM THEREFOR",
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-US Patent Application Reference Number END8563USNP2 / 180139-2, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE",
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U.S. Patent Application Reference Number END8564USNP2 / 180140-2, entitled "MECHANIMSS FOR CONTROLLING DIFFERENT ELECTROMECANICAL SYSTEM SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT",
U.S. Patent Application Reference Number END8564USNP3 / 180140-3, entitled "DECTION OF END EFFECTOR IMMERSION IN LIQUID",
U.S. Patent Application Reference Number END8565USNP 1/1801421, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACTIVE COUPLING",
-US Patent Application Reference Number END8565USNP2 / 180142-2, entitled "INCREASING RADIO FREENCY TO CREATE PAD-LESS MONOPOLAR LOOP",
U.S. Patent Application Reference Number END8566USNP1 / 180143-1, and "ACTIVERATION

The applicant of the present application owns the following US patent application filed on August 23, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 62 / 721,995, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCRDING TO TISSUE LOCATION",
U.S. Patent Application No. 62 / 721,998, entitled "Situational Awareness OF ELECTROSURGICAL SYSTEMS",
U.S. Patent Application No. 62 / 721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACTIVE COUPLING",
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The applicant of the present application owns the following US patent application filed June 30, 2018, the entire disclosure of which is incorporated herein by reference.
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The applicant of the present application owns the following US patent application filed June 29, 2018, the entire disclosure of which is incorporated herein by reference.
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The applicant of the present application owns the following US patent provisional application filed June 28, 2018, the entire disclosure of which is incorporated herein by reference.
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The applicant of the present application owns the following US patent provisional application filed April 19, 2018, of which the entire disclosure is incorporated herein by reference.
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The applicant of the present application owns the following US patent provisional application filed March 30, 2018, of which the entire disclosure is incorporated herein by reference.
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The applicant of the present application owns the following US patent application filed March 29, 2018, the entire disclosure of which is incorporated herein by reference.
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U.S. Patent Application No. 15 / 940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES",
U.S. Patent Application Nos. 15 / 940, 706 entitled "DATA HANDLING AND PRIORIZATION IN A CLOUD ANALYTICS NETWORK" and-U.S. Patent Application No. 15 / 940, 706 entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICE".
U.S. Patent Application No. 15 / 940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application No. 15 / 940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application No. 15 / 940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application No. 15 / 940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application No. 15 / 940,680 entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application No. 15 / 940,683, entitled "COOPERATION SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application Nos. 15/940, 690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" and- "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL

The applicant of the present application owns the following US patent provisional application filed March 28, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES",
U.S. Patent Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PAIENT RECORDS AND CREATE ANONYMIZED RECORD",
-US Patent Provisional Application No. 62 / 649,300, entitled "SURGICAL HUB Situational Awareness",
U.S. Patent Application No. 62 / 649,309, entitled "SURGICAL HUB SPARC AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER",
U.S. Patent Application No. 62 / 649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS",
-US Patent Provisional Application No. 62 / 649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERMENTIES OF BACK SCATTERED LIGHT",
U.S. Patent Application No. 62 / 649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES",
-US Patent Provisional Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZETION AND RECOMMENDATIONS TO A USER",
U.S. Patent Application No. 62 / 649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES",
U.S. Patent Application No. 62 / 649,315, entitled "DATA HANDLING AND PRIORIZATION IN A CLOUD ANALYTICS NETWORK",
U.S. Patent Application No. 62 / 649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES",
U.S. Patent Application No. 62 / 649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Provisional Application No. 62 / 649,307 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" and- "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED US Patent No. 62 / 649, 307" issue.

The applicant of the present application owns the following US patent provisional application filed March 8, 2018, of which the entire disclosure is incorporated herein by reference.
U.S. Patent Provisional Application No. 62 / 640,417 entitled "TEMPERATURE CONTOROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", and ・ "ESTIMATING STATE OF ULTRASONIC END FOR , 415.

The applicant of the present application owns the following US patent provisional application filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
US Patent Provisional Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM", US Patent Provisional Application No. 62 / 611,341,
-US Patent Provisional Application No. 62 / 611,340 entitled "CLOUD-BASED MEDICAL ANALYTICS" and-US Patent Provisional Application No. 62 / 611,339 entitled "ROBOT ASSISTED SURGICAL PLATFORM".

Prior to elaborating on the various aspects of surgical devices and generators, the illustrated examples are not limited in application or application to the details of the structure and arrangement of the parts shown in the accompanying drawings and description. It should be noted. The exemplary examples may be implemented or incorporated in other embodiments, variants, and modifications, and may be implemented or implemented in a variety of ways. Furthermore, unless otherwise stated, the terms and expressions used herein have been selected for the convenience of the reader to illustrate exemplary examples and are not intended to limit them. .. In addition, one or more of the embodiments, embodiments, and / or examples described below, and any of the other embodiments, embodiments, and / or examples described below. It should be understood that it can be combined with one or more.

Various aspects are intended for improved ultrasonic surgical equipment, electrosurgical equipment, and generators for use with them. Aspects of ultrasonic surgical devices can be configured, for example, to transversely incis and / or coagulate tissue during a surgical procedure. Aspects of electrosurgical devices can be configured, for example, to transversely incis, coagulate, scale, weld and / or dry tissue during a surgical procedure.

Referring to FIG. 1, a computer-mounted interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (eg, a cloud 104 that may include a remote server 113 coupled to a storage device 105). ,including. Each surgical system 102 includes at least one surgical hub 106 that communicates with a cloud 104 that may include a remote server 113. In one embodiment, as shown in FIG. 1, the surgical system 102 is configured to communicate with each other and / or with the hub 106, a visualization system 108, a robot system 110, and a handheld intelligent surgical instrument 112. And, including. In some embodiments, the surgical system 102 may include M hubs 106, N visualization systems 108, O robot systems 110, and P handheld intelligent surgical instruments 112. , Where M, N, O, and P are integers greater than or equal to 1.

FIG. 3 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in an operating room 116. The robot system 110 is used as part of the surgical system 102 in the surgical procedure. The robot system 110 includes a surgeon's console 118, a patient-side cart 120 (surgical robot), and a surgical robot hub 122. The patient-side cart 120 can operate at least one detachably coupled surgical tool 117 during a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. .. An image of the surgical site can be obtained by the medical imaging device 124, which can be manipulated by the patient-side cart 120 to orient the imaging device 124. The robot hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

Other types of robot systems can be easily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with this disclosure are entitled "ROBOT ASSISTED SURGICAL PLATFORM" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in US Patent Provisional Application No. 62 / 611,339.

Various examples of cloud-based analysis performed by Cloud 104 and suitable for use with this disclosure are described in "CLOUD-BASED MEDICAL" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in US Patent Provisional Application No. 62 / 611,340 entitled "ANALYTICS".

In various aspects, the imaging device 124 comprises at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. One or more illumination sources may be oriented to illuminate part of the surgical field. One or more image sensors may receive reflected or refracted light from the surgical field, including light reflected or refracted from tissues and / or surgical instruments.

One or more illumination sources may be configured to radiate electromagnetic energy within the visible and invisible spectra. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is a portion of the electromagnetic spectrum visible to the human eye (ie, detectable by the human eye) and is sometimes referred to as visible light, or simply light. The typical human eye responds to wavelengths in the air from about 380 nm to about 750 nm.

The invisible spectrum (ie, the non-emissive spectrum) is a portion of the electromagnetic spectrum located below and above the visible spectrum (ie, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths above about 750 nm are longer than the red visible spectrum, which results in invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which results in invisible UV, X-ray, and gamma-ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include arthroscopy, angioscope, bronchoscope, biliary tract, colonoscope, cytoscope, duodenalscope, endoscopy, esophagogastroduodenalscope (gastroscope) , Endoscope, laryngoscope, nasopharyngo-neproscope, sigmoid colonoscope, thoracoscope, and cystoscope, but not limited to these.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlayer structure. A multispectral image captures image data within a specific wavelength range over an electromagnetic spectrum. Wavelengths can be separated by filters or by using devices that are sensitive to light from frequencies beyond the visible light range, such as IR and ultraviolet light. Spectral imaging can allow the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is an "Advanced Imaging" of US Patent Provisional Application No. 62 / 611,341 entitled "INTERACTIVE SURGICAL PLATFORM" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is explained in detail in the section "Acquisition Module". Multispectral monitoring can be a useful tool for rearranging surgical fields to perform one or more of the above tests on treated tissue after one surgical operation has been completed.

It is self-evident that any surgical procedure requires strict sterilization of the operating room and surgical instruments. The "surgical theater", that is, the strict hygiene and sterilization conditions required for operating rooms or treatment rooms, require the highest degree of sterilization of all medical devices and equipment. Part of the sterilization process is the need to sterilize anything that comes into contact with the patient or invades the sterilization field, including the imaging device 124 and its accessories and components. The sterile field can be considered as a specific area considered to be free of microorganisms, such as in a tray or on a sterile towel, or the sterile field is considered to be the area immediately surrounding the patient prepared for the surgical procedure. It will be understood that it can be done. The sterile field may include washed team members wearing appropriate clothing, as well as all fixtures and fixtures within the area.

In various aspects, the visualization system 108 comprises one or more imaging sensors strategically placed relative to the sterile field and one or more image processing units, as shown in FIG. And one or more storage arrays and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. For the various components of the visualization system 108, US Patent Provisional Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM", filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in the section "Advanced Imaging Acquisition Model".

As shown in FIG. 2, the primary display 119 is arranged in the sterile field so that it is visible to the operator located on the operating table 114. In addition, the visualization tower 111 is located outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. The visualization system 108 guided by the hub 106 is configured to use displays 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the hub 106 causes the visualization system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109 while maintaining a live image of the surgical site on the primary display 119. Can be done. Snapshots on the non-sterile display 107 or 109 can allow, for example, a non-sterile operator to perform surgical steps related to the surgical procedure.

In one aspect, the hub 106 sends diagnostic input or feedback input by a non-sterile operator located at the visualization tower 111 to the primary display 119 within the sterilization area in the sterilization field, which is a sterilization operation located on the operating table. It is also configured so that one can see it. In one embodiment, the input may be in the form of a modification to the snapshot displayed on the non-sterile display 107 or 109, which can be sent by the hub 106 to the primary display 119.

With reference to FIG. 2, the surgical instrument 112 is used as part of the surgical system 102 in the surgical procedure. The hub 106 is also configured to coordinate the flow of information to the display of the surgical instrument 112. For example, in US Patent Provisional Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback input by the non-sterile operator at the location of the visualization tower 111 may be sent by the hub 106 to the surgical instrument display 115 in the sterile field, where the diagnostic input or feedback is on the surgical instrument 112. It may be seen by the operator. For exemplary surgical instruments suitable for use with the surgical system 102, for example, in the section "SURGICAL INSTRUMENT HARDWARE", and the entire disclosure thereof is incorporated herein by reference. It is described in US Patent Provisional Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE Surgery PLATFORM".

With reference to FIG. 3, the hub 106 is shown communicating with the visualization system 108, the robot system 110, and the handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In a particular embodiment, as shown in FIG. 3, the hub 106 further includes a smoke exhaust module 126 and / or a suction / irrigation module 128.

During the surgical procedure, applying energy to the tissue for sealing and / or cutting generally involves flue gas, aspiration of excess fluid, and / or irrigation of the tissue. Fluids, power, and / or data lines from different sources are often entangled during the surgical procedure. Addressing this issue during a surgical procedure can result in the loss of valuable time. Untangling the lines may require pulling the lines out of their corresponding modules, which may require resetting the modules. The modular housing 136 of the hub provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line entanglements.

Aspects of the present disclosure present a surgical hub for use in surgical procedures involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module that is slidably acceptable within the docking station of the hub housing. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a unipolar RF energy generator component housed in a single unit. .. In one aspect, the combination generator module further comprises a smoke exhaust component, at least one energy supply cable for connecting the combination generator module to the surgical instrument, and smoke generated by the application of therapeutic energy to the tissue. Includes at least one flue gas component configured to expel fluid, and / or particulates, and a fluid line extending from the remote surgery site to the flue gas component.

In one aspect, the fluid line is the first fluid line and the second fluid line extends from the remote surgery site to the suction and irrigation module slidably received within the hub housing. In one aspect, the hub housing comprises a fluid interface.

Certain surgical procedures may require the application of more than one energy type to the tissue. One energy type can be more beneficial for cutting tissue, while another different energy type can be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal the tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which a modular enclosure 136 of a hub is configured to accommodate various generators and facilitate two-way communication between them. One of the advantages of the modular housing 136 of the hub is that it allows for rapid removal and / or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure comprises a first energy generator module configured to generate a first energy to be applied to the tissue and a first docking port containing first data and power contacts. A first docking station, including a first docking station, the first energy generator module is slidably movable to electrically engage with power and data contacts, and the first energy generator module is: It is slidable and movable so as to disengage from the electrical engagement with the first power and data contacts.

In addition to the above, the modular surgical enclosure has a second energy generator module configured to generate a second energy to be applied to the tissue, which is different from the first energy, and a second. A second docking station with a second docking port containing the data and power contacts of the second energy generator module is slidably moved to electrically engage the power and data contacts. It is possible and the second energy generator module is slidably movable so as to disengage from the electrical engagement with the second power and data contacts.

In addition, the modular surgical enclosure is configured to facilitate communication between the first energy generator module and the second energy generator module, with a first docking port and a second docking. It also includes a communication bus to and from the port.

Referring to FIGS. 3-7, aspects of the present disclosure relating to a modular housing 136 of a hub that allows modular integration of a generator module 140, a smoke exhaust module 126, and a suction / irrigation module 128 are presented. Will be done. The modular housing 136 of the hub further facilitates bidirectional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 is integrated into a single housing unit 139 that is slidably insertable into the modular housing 136 of the hub. It may be a generator module with sound wave components. As shown in FIG. 5, the generator module 140 may be configured to connect to a unipolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of unipolar, bipolar, and / or ultrasonic generator modules that interact via the modular housing 136 of the hub. The modular housing 136 of the hub allows multiple generators to be inserted and bidirectional between the generators docked in the modular housing 136 of the hub so that the multiple generators function as a single generator. It may be configured to facilitate communication.

In one aspect, the modular enclosure 136 of the hub comprises modular power and with external and wireless communication headers to allow removable mounting of modules 140, 126, 128 and bidirectional communication between them. A communication backplane 149 is provided.

In one aspect, the modular housing 136 of the hub includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and the combination generator module 145 slidably acceptable to the docking station 151 of the surgical hub housing 136. The docking port 152, which has power and data contacts on the rear side of the combination generator module 145, is configured when the combination generator module 145 is slid into a position within the corresponding docking station 151 of the modular housing 136 of the hub. The corresponding docking port 150 is configured to engage the power and data contacts of the corresponding docking station 151 of the modular enclosure 136 of the hub. In one aspect, the combination generator module 145 includes a bipolar, ultrasonic, and unipolar module and a smoke exhaust module integrated with a single housing unit 139, as shown in FIG.

In various aspects, the smoke exhaust module 126 includes a fluid line 154 that transports captured / recovered smoke and / or fluid away from the surgical site, eg, to the smoke exhaust module 126. The vacuum suction generated from the smoke exhaust module 126 can draw smoke into the opening of the utility conduit at the surgical site. The utility conduit coupled to the fluid line may be in the form of a flexible tube terminated at the smoke exhaust module 126. Utility conduits and fluid lines define a fluid path extending towards the smoke exhaust module 126 received within the hub housing 136.

In various aspects, the suction / irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one embodiment, the suction and suction fluid line is in the form of a flexible tube extending from the surgical site towards the suction / irrigation module 128. One or more drive systems may be configured to cause fluid irrigation and inhalation into and from the surgical site.

In one aspect, the surgical tool comprises a shaft having an end effector at its distal end, at least one energy treatment section associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and can have an inlet port in close proximity to the energy delivery device. The energy delivery device is configured to deliver ultrasonic and / or RF energy to the surgical site and is first coupled to the generator module 140 by a cable that extends through the shaft.

The irrigation pipe can communicate with the fluid source, and the suction pipe can communicate with the vacuum source. The fluid source and / or vacuum source may be housed in the suction / irrigation module 128. In one embodiment, the fluid source and / or vacuum source may be housed in the hub housing 136 separately from the suction / irrigation module 128. In such an embodiment, the fluid interface may be configured to connect the suction / irrigation module 128 to a fluid source and / or a vacuum source.

In one aspect, their corresponding docking stations on modules 140, 126, 128 and / or the modular housing 136 of the hub align the docking ports of the modules to the docking stations of the modular housing 136 of the hub. It may include an alignment mechanism configured to engage these corresponding components within. For example, as shown in FIG. 4, the combination generator module 145 is configured to slidably engage the corresponding bracket 156 of the corresponding docking station 151 of the modular housing 136 of the hub. Includes 155. The brackets work together to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the modular housing 136 of the hub.

In some embodiments, the drawer 151 of the modular housing 136 of the hub is the same or substantially the same size, and the module is adjusted to a size that is acceptable within the drawer 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In another aspect, the drawer 151 is of different size and is designed to accommodate a particular module.

In addition, the contacts of a particular module may be locked to engage the contacts of a particular drawer to avoid inserting the module into a drawer with incompatible contacts.

As shown in FIG. 4, a docking port 150 of one drawer 151 is coupled to a docking port 150 of another drawer 151 via a communication link 157 and housed in a modular housing 136 of the hub. Two-way communication between them can be facilitated. Alternatively, or further, the docking port 150 of the modular housing 136 of the hub may facilitate wireless bidirectional communication between the modules housed in the modular housing 136 of the hub. For example, any suitable wireless communication such as Air Titan-Bluetooth may be used.

FIG. 6 shows the individual power bus attachments of the plurality of lateral docking ports of the laterally modular housing 160 configured to receive the plurality of modules of the surgical hub 206. The laterally modular housing 160 is configured to laterally receive and interconnect the modules 161. The module 161 is slidably inserted into the docking station 162 of the lateral modular housing 160, which includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the module 161 is arranged laterally within the laterally modular housing 160. Alternatively, the module 161 may be arranged vertically within the laterally modular housing.

FIG. 7 shows a vertical modular housing 164 configured to receive multiple modules 165 of the surgical hub 106. The module 165 is slidably inserted into the docking station or drawer 167 of the vertical modular housing 164 including the backplane for interconnecting the modules 165. Although the drawer 167 of the vertical modular housing 164 is arranged vertically, in certain cases the vertical modular housing 164 may include a drawer arranged laterally. Further, the modules 165 can interact with each other via the docking port of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 for displaying data related to the operation of module 165 is provided. In addition, the vertical modular housing 164 includes a master module 178 that houses a plurality of submodules that are slidably received within the master module 178.

In various aspects, the imaging module 138 comprises a built-in video processor and modular light source and is adapted for use with a variety of imaging devices. In one aspect, the imaging device comprises a modular housing that can be assembled with a light source module and a camera module. The housing may be a disposable housing. In at least one embodiment, the disposable housing is detachably coupled with a reusable controller, light source module, and camera module. The light source module and / or the camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module comprises a CMOS sensor. In another aspect, the camera module is configured for imaging the scanned beam. Similarly, the light source module can be configured to deliver white light or different light depending on the surgical procedure.

During the surgical procedure, it may be inefficient to remove the surgical device from the surgical field and replace it with another surgical device containing a different camera or different light source. Temporary loss of field of view in the surgical field can have undesired consequences. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or camera module intermediate (midstream) during a surgical procedure without the need to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing that includes a plurality of channels. The first channel is configured to slidably accept a camera module that may be configured to snap fit and engage with the first channel. The second channel is configured to slidably accept a light source module that may be configured to snap fit and engage with the second channel. In another embodiment, the camera module and / or light source module can be rotated to its final position within these corresponding channels. Screw engagement may be employed instead of snap fit engagement.

In various embodiments, multiple imaging devices are positioned at different locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use with the present disclosure are US Pat. Nos. 6, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which are incorporated herein by reference in their entirety. It is described in No. 7,995,045. In addition, US Pat. No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, removes motion artifacts from image data. Describes various systems for doing so. Such a system can be integrated with the imaging module 138. In addition, the US Patent Application Publication No. 2011/0306840 published on December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE TO FIXTURE INTRACORPORTAL APPARATUS", and "SYSTEM FOR PERFORMING A MEMRAL 2014" Published US Patent Application Publication No. 2014/0243597, each of which is incorporated herein by reference in its entirety.

FIG. 8 shows a cloud-based system (eg, storage) of modular equipment located in one or more operating rooms of a medical facility, or in any room within a medical facility equipped with specialized equipment for surgical procedures. FIG. 6 shows a surgical data network 201 with a modular communication hub 203 configured to connect to a cloud 204) that may include a remote server 213 coupled to device 205. In one aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 can also be coupled to the local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switchable. Passive surgical data networks act as conduits for data, allowing data to travel from one device (or segment) to another (or segment) and to cloud computing resources. The intelligent surgical data network allows traffic to pass through the monitored surgical data network and includes additional mechanisms that make up each port within the network hub 207 or network switch 209. Intelligent surgical data networks can be referred to as manageable hubs or switches. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

Modular devices 1a-1n arranged in the operating room may be coupled to the modular communication hub 203. The network hub 207 and / or the network switch 209 can be coupled to the network router 211 to connect the devices 1a to 1n to the cloud 204 or the local computer system 210. The data associated with the devices 1a-1n may be transferred to a cloud-based computer via a router for remote data processing and operation. The data associated with the devices 1a-1n may also be transferred to the local computer system 210 for local data processing and operation. Modular devices 2a-2m located in the same operating room may also be coupled to the network switch 209. The network switch 209 can be coupled to the network hub 207 and / or the network router 211 to connect the devices 2a to 2m to the cloud 204. The data associated with the devices 2a-2n may be transferred to the cloud 204 via the network router 211 for data processing and operation. The data associated with the devices 2a-2m may also be transferred to the local computer system 210 for local data processing and operation.

It will be appreciated that the surgical data network 201 can be extended by interconnecting the plurality of network hubs 207 and / or the plurality of network switches 209 with the plurality of network routers 211. The modular communication hub 203 may be housed in a modular control tower configured to receive a plurality of devices 1a-1n / 2a-2m. The local computer system 210 may also be housed in a modular control tower. The modular communication hub 203 is connected to the display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example during a surgical procedure. In various aspects, the devices 1a-1n / 2a-2m include, among other modular devices that can be connected to the modular communication hub 203 of the surgical data network 201, for example, an imaging module 138 coupled to an endoscope. , Generator module 140 coupled to energy-based surgical equipment, smoke exhaust module 126, suction / irrigation module 128, communication module 130, processor module 132, storage array 134, surgical equipment coupled to display, and / Alternatively, various modules such as non-contact sensor modules may be mentioned.

In one aspect, the surgical data network 201 combines a network hub (s), a network switch (s), and a network router (s) that connect the devices 1a-1n / 2a-2m to the cloud. It may be included. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and operation. .. It will be appreciated that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. The term "cloud" can be used as a metaphor for the "Internet," but the term is not so limited. Therefore, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing," in which case various services such as servers, storage, and applications are surgical. Modular communication hub 203 and / or computer system 210 located in the field (eg, fixed, mobile, temporary, or field operating room or space) and / or via the Internet. Delivered to a device connected to computer system 210. The cloud infrastructure can be maintained by the cloud service provider. In this context, a cloud service provider can be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform a number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to computers that communicate with cloud computing resources and storage.

By applying cloud computer data processing technology to the data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. After the tissue sealing and cutting procedure, at least some of the devices 1a-1n / 2a-2m can be used to observe the condition of the tissue and assess leakage or perfusion of the sealed tissue. .. At least one of the devices 1a-1n / 2a-2m to use cloud-based computing to examine data containing images of body tissue samples for diagnostic purposes to identify medical conditions such as the effects of disease. Some can be used. This includes tissue and phenotypic localization and margin confirmation. Devices 1a-1n / 2a to identify the anatomical structure of the body using techniques such as overlaying images captured by multiple imaging devices and various sensors integrated with the imaging device. At least some of ~ 2 m can be used. Data collected by devices 1a-1n / 2a-2m, including image data, may be transferred to cloud 204 and / or local computer system 210 for data processing and operation, including image processing and operation. .. The data of surgical procedures by determining whether further treatments such as endoscopic interventions for tissue-specific sites and conditions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robots can be performed. It can be analyzed to improve the results. Such data analysis may further employ prognostic processing, and whether using a standardized approach confirms surgical treatment and surgeon behavior or suggests modifications to surgical treatment and surgeon behavior. Can provide useful feedback for any of the above.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired or wireless channel, depending on the configuration of the devices 1a-1n with respect to the network hub. In one aspect, the network hub 207 may be implemented as a local network broadcaster acting on the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 collects data in packet form and sends them to the router in half-duplex mode. The network hub 207 does not store any medium access control / internet protocol (MAC / IP) for transferring device data. Only one of the devices 1a-1n can transmit data at a time via the network hub 207. The network hub 207 does not have a routing table or intelligence regarding the destination of information, and broadcasts all network data to the entire connection and to the remote server 213 (FIG. 9) on the cloud 204. The network hub 207 can detect basic network errors such as collisions, but broadcasting all the information to a plurality of ports poses a security risk and may cause a bottleneck.

In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired or wireless channel. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operating room to the network. The network switch 209 transmits data in the form of a frame to the network router 211 and functions in full-duplex mode. The plurality of devices 2a to 2m can simultaneously transmit data via the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a to 2m to transfer data.

The network hub 207 and / or network switch 209 is coupled to the network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 cloud the data packets received from the network hub 207 and / or the network switch 211 in order to further process and manipulate the data collected by any one or all of the devices 1a-1n / 2a-2m. Create a route to send to the base computer resource. The network router 211 is used to connect two or more different networks located at different locations, for example, different operating rooms in the same medical facility or different networks located in different operating rooms in different medical facilities. May be good. The network router 211 transmits packet form data to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data at the same time. The network router 211 uses an IP address to transfer data.

In one embodiment, the network hub 207 may be implemented as a USB hub that allows a plurality of USB devices to be connected to a host computer. A USB hub can extend a single USB port into several layers so that more ports are available to connect the device to the host system computer. The network hub 207 may include a wired or wireless capability for receiving information via a wired or wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.

In another embodiment, operating room devices 1a-1n / 2a-2m exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band 2.4-2.485 GHz). ), And can communicate with the modular communication hub 203 via the Bluetooth radio technology standard to build a personal area network (PAN). In another aspect, the operating room devices 1a-1n / 2a-2m are Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, long-term evolution, LTE), and Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any designated as 3G, 4G, 5G, and beyond. It is possible to communicate with the modular communication hub 203 via a number of wireless or wired communication standards or protocols, including but not limited to other wireless and wired protocols. The computing module may include a plurality of communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. May be dedicated to long-range wireless communication.

The modular communication hub 203 can function as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles a data type known as a frame. The frame carries the data generated by the devices 1a-1n / 2a-2m. When the frame is received by the modular communication hub 203, the frame is amplified and transmitted to the network router 211, which uses a number of wireless or wired communication standards or protocols described herein. Transfer this data to your cloud computing resources.

The modular communication hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communication hub 203 is generally easy to install, configure, and maintain, making the modular communication hub 203 a good choice for networking operating room devices 1a-1n / 2a-2m.

FIG. 9 shows a computer-mounted interactive surgical system 200. The computer-mounted interactive surgical system 200 is, in many respects, similar to the computer-mounted interactive surgical system 100. For example, the computer-mounted interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include a remote server 213. In one aspect, the computer-mounted interactive surgical system 200 comprises a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. .. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to the computer system 210. As illustrated in the embodiment of FIG. 9, the modular control tower 236 includes an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator module 226, and suction / It is coupled to the irrigation module 228, the communication module 230, the processor module 232, the storage array 234, the smart device / appliance 235 optionally coupled to the display 237, and the non-contact sensor module 242. The operating room equipment is coupled to cloud computing resources and data storage via a modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. Above all, the device / appliance 235, visualization system 208 may be coupled to the modular control tower 236 via a wired or wireless communication standard or protocol described herein. Modular control tower 236 may be coupled to hub display 215 (eg, monitor, screen) to display and overlay images received from imaging modules, device / instrument displays, and / or other visualization systems 208. .. The hub display may also display data received from a device connected to the modular control tower along with images and overlay images.

FIG. 10 shows a surgical hub 206 with a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes, for example, a modular communication hub 203 such as a network connection device and a computer system 210 for providing, for example, local processing, visualization, and imaging. As shown in FIG. 10, the modular communication hub 203 is connected in a hierarchical configuration in order to expand the number of modules (for example, devices) that can be connected to the modular communication hub 203, and the data associated with the modules is displayed. It can be transferred to computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches in the modular communication hub 203 includes three downstream ports and one upstream port. Upstream network hubs / switches are connected to processors to provide communication connections to cloud computing resources and local displays 217. Communication to the cloud 204 can be done via either a wired or wireless communication channel.

The surgical hub 206 uses the non-contact sensor module 242 to measure the dimensions of the operating room and uses either an ultrasonic or laser non-contact measuring device to generate a map of the surgical site. Section "Surgical Hub Special Awarenes With Operating Room" of US Patent Provisional Application No. 62 / 611,341 entitled "INTERACTIVE SURGICAL PLATFORM" filed December 28, 2017, which is incorporated herein by reference in its entirety. As described in, the ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound and receiving an echo as the burst of ultrasound reflects off the outer wall of the operating room. Here, the sensor module is configured to determine the size of the operating room and adjust the distance limits of the Bluetooth pairing. A laser-based non-contact sensor module, for example, transmits a laser light pulse, receives a laser light pulse reflected on the outer wall of the operating room, and compares the phase of the transmitted pulse to the received pulse in the operating room. The operating room is scanned by determining the size and adjusting the Pulsetooth pairing distance limit.

The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to the communication module 247, storage 248, memory 249, non-volatile memory 250, and input / output interface 251 via the system bus. The system bus is a 9-bit bus, industry standard architecture (ISA), microchannel architecture (MSA), extended ISA (EISA), intelligent drive electronics (IDE), VESA local bus (VLB), peripheral device interconnection (PCI), Any, but not limited to, USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association Bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus. It may be any of several types of bus structures (s), including memory buses or memory controllers, peripheral or external buses, and / or local buses that use different bus architectures.

The processor 244 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In one aspect, the processor, for example, on-chip memory of up to 40 MHz 256 KB single cycle flash memory or other non-volatile memory, the details of which are available in the product datasheet, to improve performance to over 40 MHz. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2KB electrically erasable programmable read-only memory (electrically erasable) programmable read-only memory, EEPROM) and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QEI) analogs. In the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including one or more 12-bit analog-digital converters (ADCs) with 12 analog input channels. There may be.

In one aspect, the processor 244 may include a safety controller that includes two controller families such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options. Good.

Examples of the system memory include volatile memory and non-volatile memory. A basic input / output system (BIOS) that includes a basic routine for transferring information between elements in a computer system, such as during startup, is stored in non-volatile memory. For example, the non-volatile memory may include ROM, programmable ROM (programmable ROM, PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Examples of the volatile memory include a random access memory (RAM) that functions as an external cache memory. Further, the RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESRAM), synclink DRAM (SLRAM), direct rambus RAM (DRRAM), and the like. It is available in many forms of.

The computer system 210 also includes removable / non-removable volatile / non-volatile computer storage media such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage can be a storage medium independently, or a compact disc ROM device (CD-ROM), a compact disc recordable drive (CD-R drive), a compact disc rewritable drive (CD-RW drive), and the like. Alternatively, an optical disk drive such as a digital versatile disk ROM drive (DVD-ROM) can be mentioned, but the present invention can be included in combination with other storage media not limited thereto. A removable or non-removable interface may be used to facilitate the connection of the disk storage device to the system bus.

It should be understood that the computer system 210 includes software that acts as an intermediary between the user and the basic computer resources described in the preferred operating environment. Examples of such software include operating systems. An operating system that can be stored on disk storage functions to control and allocate resources for the computer system. System applications take advantage of resource management by the operating system via program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein can be implemented in different operating systems or combinations of operating systems.

The user inputs a command or information to the computer system 210 via an input device (s) coupled to the I / O interface 251. Input devices include pointing devices such as mice, trackballs, stylus, and touchpads, keyboards, microphones, joysticks, gamepads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, and webcams. However, it is not limited to these. These and other input devices connect to the processor through the system bus via the interface port (s). Examples of the interface port (s) include a serial port, a parallel port, a game port, and USB. The output device (s) use some of the same types of ports as the input device (s). Thus, for example, the USB port may be used to provide input to the computer system and output information from the computer system to the output device. Output adapters are provided to indicate the presence of some output devices, such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters include, for example, but not limited to, video and sound cards that provide a means of connection between the output device and the system bus. Note that other devices and / or systems of devices, such as remote computers (s), provide both input and output functions.

The computer system 210 can operate in a networked environment that uses a logical connection to one or more remote computers or local computers, such as a cloud computer (s). The remote cloud computer (s) can be a personal computer, server, router, network PC, workstation, microprocessor-based device, peer device, or other common network node, typically a computer. Contains many or all of the elements described for the system. For brevity, only the memory storage device is shown along with the remote computer (s). The remote computer (s) are logically connected to the computer system via a network interface and then physically connected via a communication connection. Network interfaces include communication networks such as local area networks (LANs) and wide area networks (WANs). Examples of LAN technology include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE802.3, Token Ring / IEEE802.5 and the like. WAN technologies include point-to-point links, integrated services digital networks (ISDN) and their variants and other circuit exchange networks, packet exchange networks, and digital subscriber lines (DSL). Is not limited to these.

In various embodiments, the computer system 210 of FIG. 10, the imaging module 238 of FIGS. 9-10, and / or the visualization system 208, and / or the processor module 232 are image processors, image processing engines, media processors, or digital images. It may include any dedicated digital signal processor (DSP) used in the processing of. Image processors use parallel computing with single instruction, multiple data, SIMD, or multiple instruction, multiple data, MIMD technology to increase speed and efficiency. Can be done. Digital image processing engines can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

Communication connection (s) refers to the hardware / software used to connect the network interface to the bus. The communication connection is shown inside the computer system for the sake of illustration clarity, but the communication connection may be outside the computer system 210. For illustrative purposes only, the hardware / software required to connect to a network interface includes conventional telephone grade modems, cable modems, modems including DSL modems, ISDN adapters, and internal and external technologies such as Ethernet cards. Can be mentioned.

FIG. 11 shows a functional block diagram of one aspect of the USB network hub 300 device according to at least one aspect of the present disclosure. In the illustrated embodiment, the USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that provides upstream USB transmission / reception ports 302 and up to three downstream USB transmission / reception ports 304, 306, and 308 that comply with the USB 2.0 standard. The upstream USB transmit / receive port 302 is a differential root data port that includes a differential data plus (DP0) input and a paired differential data minus (DM0) input. The three downstream USB transmit / receive ports 304, 306, 308 are differential data ports each containing a differential data plus (DP1 to DP3) output paired with a differential data minus (DM1 to DM3) output.

The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. A fully compliant USB transmitter / receiver is integrated into the circuits of the upstream USB transmit / receive port 302 and all downstream USB transmit / receive ports 304, 306, 308. Downstream USB transmit and receive ports 304, 306, 308 support both maximum and slow speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered mode or self-powered mode and includes hub-powered logic 312 for managing power.

The USB network hub 300 device includes a serial interface engine (SIE). The SIE310 is the front end of the USB network hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. The SIE310 typically understands signaling down to the transaction level. The functions it handles include packet recognition, transaction reordering, SOP, EOP, SETET, and RESUME signal detection / generation, clock / data separation, and non-return-to-zero invert (NRZI) data. Coding / decoding and bit stuffing, CRC generation and checking (tokens and data), packet ID (PID) generation and checking / decoding, and / or serial-parallel / parallel-serial conversion can be mentioned. 310 receives clock input 314 and suspend / resume logic as well to control communication between upstream USB transmit / receive ports 302 and downstream USB transmit / receive ports 304, 306, 308 via port logic circuits 320, 322, 324. It is coupled to the frame timer 316 circuit and the hub repeater circuit 318. The SIE 310 is coupled to the command decoder 326 via interface logic for controlling commands from the serial EEPROM via the serial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functions configured in up to 6 logical layers (hierarchies) to a single computer. In addition, the USB network hub 300 can be connected to all peripherals using four standardized wire cables that provide both communication and power distribution. The power configuration is a bus-powered mode and a self-powered mode. The USB network hub 300 is a bus power hub having either individual port power management or interlocking port power management, and a self-powered hub having either individual port power management or interlocking port power management. It may be configured to support one mode. In one aspect, using a USB cable, a USB network hub 300, the upstream USB transmit / receive port 302 is plugged into a USB host controller, and the downstream USB transmit / receive ports 304, 306, 308 connect a USB compatible device. It is exposed because of it.

Hardware of Surgical Instruments FIG. 12 shows a logical diagram of a surgical instrument or tool control system 470 according to one or more aspects of the present disclosure. System 470 includes a control circuit. The control circuit includes a microprocessor 461 with a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, and 476 provide real-time feedback to the processor 462. The motor 482, driven by the motor driver 492, operably couples displacement members that are movable in the longitudinal direction to drive the clamp arm closing member. The tracking system 480 is configured to determine the position of a displacement member that is movable in the longitudinal direction. The position information is provided to the processor 462 which can be programmed or configured to determine the position of the drive member and the position of the closing member which can be moved in the longitudinal direction. Additional motors may be provided in the tool driver interface to control the movement of the closure tube, rotation of the shaft, joint movement, or closure of the clamp arm, or any combination of the above. The display 473 may display various operating conditions of the appliance and may include a touch screen function for data entry. The information displayed on the display 473 can be overlaid with the image acquired via the endoscopic imaging module.

In one aspect, the microcontroller 461 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In one aspect, the main microcontroller 461 improves performance to over 40 MHz, for example, on-chip memory of 256 KB single cycle flash memory up to 40 MHz or other non-volatile memory, the details of which are available in the product datasheet. Prefetch buffer for, 32KB single cycle SRAM, internal ROM with NonvolatilesWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and / Alternatively, it may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including one or more 12-bit ADCs with 12 analog input channels.

In one aspect, the microcontroller 461 may include a safety controller that includes two controller families such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options. Good.

The microcontroller 461 may be programmed to perform various functions such as a knife, joint movement system, clamp arm, or precise control of speed and position of the combination described above. In one aspect, the microcontroller 461 includes a processor 462 and memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and a mechanical connection to a joint movement or knife system. In one aspect, the motor driver 492 may be A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily replaced for use in the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system, which is incorporated herein by reference in its entirety, is entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT" published October 19, 2017 in the United States Patent Application Publication No. 2017/2017. 0296213.

The microcontroller 461 may be programmed to provide precise control over the speed and position of the displacement member and joint movement system. Microcontroller 461 may be configured to calculate the response within the software of microcontroller 461. The calculated response is compared to the measured response of the actual system to give an "observed" response, which is used to determine the actual feedback. The observed response is a suitable adjusted value that balances the smooth and continuous nature of the simulated response with the measured response, which can detect external effects on the system.

In one aspect, the motor 482 may be controlled by a motor driver 492 and may be used by a surgical instrument or tool launch system. In various forms, the motor 482 may be, for example, a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In another configuration, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including a field-effect transistor (FET). The motor 482 may be powered by a power assembly that is detachably mounted on the handle assembly or tool housing to supply control power to the surgical instrument or tool. The power assembly may include a battery that may include a large number of battery cells connected in series, which can be used as a power source to power a surgical instrument or tool. Under certain circumstances, the battery cells in the power assembly may be replaceable and / or rechargeable battery cells. In at least one example, the battery cell can be a lithium ion battery that can be coupled to and separable from the power assembly.

The motor driver 492 may be A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Is. The driver 492 is equipped with a unique charge pump regulator, which provides full (> 10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive up to 5.5V. .. A bootstrap capacitor may be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation is possible with both high-side and low-side FETs. The power FET is protected from shoot-through by a register-adjustable dead time. The integrated diagnostics indicate low voltage, overtemperature, and power bridge anomalies and can be configured to protect the power MOSFET under most short circuit conditions. Other motor drivers can be easily replaced for use in the tracking system 480 with an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuit configuration with a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for meshing and engaging with the corresponding drive gear of the gear reducer assembly. In another aspect, the displacement member represents a launching member that can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which may be adapted and configured to include a rack of drive teeth. In another aspect, the displacement member represents a clamp arm of a stapler, ultrasound, or electrosurgical device, or a clamp arm closing member configured to open and close the combination described above. Therefore, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, clamp arm, or any element that can be displaced. Will be done. Therefore, the absolute positioning system can actually track the displacement of the clamp arm by tracking the linear displacement of the drive member that is movable in the longitudinal direction. In another aspect, the absolute positioning system may be configured to track the position of the clamp arm in the opening and closing process. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, a drive member or clamp arm that is moveable in the longitudinal direction, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. Linear displacement sensors include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), slide potentiometers, movable magnets and a series of straight lines. Magnetic sensing system with placed Hall effect sensors, magnetic sensing system with fixed magnets and Hall effect sensors placed on a series of movable straight lines, movable light sources and placed on a series of straight lines It may include an optical detection system with a magneto or photodetector, an optical detection system with a fixed light source and a reluctance or photodetector arranged on a series of movable straight lines, or any combination thereof. ..

The electric motor 482 may include a rotary shaft that operably interfaces with a gear assembly mounted in mesh engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. Gearing and sensor mechanisms can be connected to linear actuators by rack and pinion mechanisms, or to rotary actuators by spur gears or other connections. The power supply powers the absolute positioning system and the output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed on it to mesh and engage with the corresponding drive gear of the gear reducer assembly. The displacement member represents a launching member that can move in the longitudinal direction to open and close the clamp arm.

One rotation of the sensor element attached to the position sensor 472 corresponds to a _{linear displacement d 1 in the longitudinal direction of the displacement member, and d 1} is the point "a" of the displacement member after one rotation of the sensor element coupled to the displacement member. It is a linear distance in the longitudinal direction that moves from "" to the point "b". The sensor mechanism may be connected via gear deceleration resulting in the position sensor 472 completing one or more rotations for the full stroke of the displacement member. The position sensor 472 can complete a plurality of rotations with respect to the full stroke of the displacement member.

A series of switches (where n is an integer greater than 1), even when used alone, in combination with gear deceleration to provide a unique position signal for two or more rotations of the position sensor 472. May be used in. The state of the switch is fed back to the microcontroller 461, which applies the logic to the longitudinal displacement of the displacement member d ₁ + d ₂ +. .. .. Determine the unique position signal corresponding to d _n. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may include an analog rotation sensor such as a magnetic sensor, a potential difference meter, or an array of analog Hall effect elements that output a unique combination of position signals or values.

The position sensor 472 may include any number of magnetic sensing elements, such as magnetic sensors that are classified based on whether or not they measure the total magnetic field or vector component of the magnetic field. The technology used to produce both types of magnetic sensors involves many aspects of physics and electronics. Techniques used for magnetic field sensing include, among other things, probe coils, flux gates, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetic resistance, giant magnetic resistance, magnetic tunnel junctions, giant magnetic impedance. , Magnetic strain / piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magnetic optics, and magnetic sensors based on microelectromechanical systems.

In one aspect, the position sensor 472 of the tracking system 480 with the absolute positioning system comprises a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055 EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 472 cooperates with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the region of the position sensor 472 located above the magnet. In addition, a high resolution ADC and smart power management controller are provided on the chip. Digit-by-digit method and boulder to implement a concise and efficient algorithm for computing hyperbolic and triangular functions that requires only addition, subtraction, bitshift, and table reference operations. A coordinate rotation digital computer (CORDIC) processor, also known as a Volder's algorithm, is provided. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface such as a serial peripheral interface (SPI) interface. The position sensor 472 provides a 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4 x 4 x 0.85 mm package.

The tracking system 480 with an absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, state feedback, and adaptive controller. The power supply converts the signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include voltage, current, and force PWM. In addition to the position measured by the position sensor 472, other sensors (s) may be provided to measure the physical parameters of the physical system. In some embodiments, as the other sensor (s), the US Pat. No. 9, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety. , 345, 481, the United States Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE TISSUE TISSUE SENSOR SYSTEM," which is incorporated herein by reference in its entirety, and in its entirety. U.S. Patent Application No. 17/28 A sensor mechanism such as a thing can be mentioned. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. Absolute positioning systems use algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response to combine the calculated response with the measured response. Can be equipped. In order to predict what the state and output of the physical system will be by knowing the inputs, the calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, and induced resistance.

The absolute positioning system resets the displacement members as would be required in a conventional rotary encoder where the motor 482 simply counts the number of steps taken forward or backward to estimate the position of device actuators, drive bars, knives, etc. Provides the absolute position of the displacement member when the appliance is powered on, without retracting or advancing to the zero or home) position.

A sensor 474, such as a strain gauge or microstrain gauge, can indicate, for example, one or more end effectors such as the amplitude of strain exerted on the anvil during clamping operation, which can indicate the closing force applied to the anvil. It is configured to measure the parameters of. The measured distortion is converted into a digital signal and provided to the processor 462. Instead of or in addition to sensor 474, for example, a sensor 476, such as a load sensor, measures the closure force that the closure drive system exerts on a stapler in an ultrasound or electrosurgical instrument or an anvil in a clamp arm. Can be done. For example, a sensor 476, such as a load sensor, can be applied to the firing force applied to the closing member coupled to the clamp arm of the surgical instrument or tool, or to the tissue located within the jaw of the ultrasonic or electrosurgical instrument by the clamp arm. It is possible to measure the force to be applied. Alternatively, a current sensor 478 can be used to measure the current draw by the motor 482. The displacement member may also be configured to engage the clamp arm to open and close the clamp arm. The force sensor may be configured to measure the clamping force on the tissue. The force required to advance the displacement member may correspond, for example, to the current drawn by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.

In one form, the strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be attached to the end effector to measure the force of the end effector on the tissue to be treated. The system for measuring the force applied to the tissue gripped by the end effector is, for example, a strain gauge sensor 474, such as a micro strain gauge configured to measure one or more parameters of the end effector. To be equipped. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the end effector jaw member during clamping operation, which can indicate tissue compression. The measured distortion is converted into a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to manipulate the knife element, for example, to cut the tissue trapped between the anvil and the staple cartridge. The load sensor 476 operates the clamp arm element, for example, to capture tissue between the clamp arm and the ultrasonic blade, or to capture tissue between the clamp arm and the jaws of an electrosurgical instrument. The force used to do this can be measured. Magnetic field sensors can be used to measure the thickness of captured tissue. The magnetic field sensor measurements can also be converted to digital signals and provided to the processor 462.

Measures of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474 and 476, respectively, are the selected position of the launching member and /. Alternatively, it can be used by the microcontroller 461 to characterize the corresponding value of the velocity of the launching member. In one example, memory 468 can store techniques, equations and / or look-up tables that can be used by microcontroller 461 during evaluation.

The surgical instrument or tool control system 470 may also include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 8-11.

FIG. 13 shows a control circuit 500 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 can be configured to implement the various processes described herein. The control circuit 500 can include a microcontroller having one or more processors 502 (eg, microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions for implementing the various processes described herein. The processor 502 may be any one of a number of single or multi-core processors known in the art. The memory circuit 504 can include volatile and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

FIG. 14 shows a combination logic circuit 510 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The combination logic circuit 510 can be configured to implement the various processes described herein. The combination logic circuit 510 is a finite state machine containing the combination logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data by combination logic 512, and provide output 516. May include.

FIG. 15 shows a sequence logic circuit 520 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The sequential logic circuit 520 or combinational logic 522 can be configured to implement the various processes described herein. The order logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, a combinatorial logic 522, at least one memory circuit 524, and a clock 529. At least one memory circuit 524 can store the current state of the finite state machine. In a particular example, the order logic circuit 520 may be synchronous or asynchronous. Combination logic 522 is configured to receive data associated with a surgical instrument or tool from input 526, process the data by combination logic 522, and provide output 528. In another aspect, the circuit may include a combination of a processor (eg, processor 502 in FIG. 13) and a finite state machine that implements the various processes herein. In another aspect, the finite state machine can include a combination of a combination logic circuit (eg, combination logic circuit 510 in FIG. 14) and a sequence logic circuit 520.

FIG. 16 shows a surgical instrument or tool with multiple motors that can be activated to perform various functions. In a particular example, the first motor can be started to perform the first function, the second motor can be started to perform the second function, and the third motor can be started. The third function can be executed, the fourth motor can be started to execute the fourth function, and so on. In certain examples, multiple motors of the robotic surgical instrument 600 can be individually activated to produce launching, closing, and / or jointing motions in the end effector. Launching motion, closing motion, and / or joint motion can be transmitted to the end effector, for example, via a shaft assembly.

In certain examples, the surgical instrument system or tool may include a launch motor 602. The launch motor 602 can be made operational to the launch motor drive assembly 604, which can be configured to transmit the launch motion generated by the motor 602 to the end effector, specifically to displace the clamp arm closing member. It may be combined. The closing member can be retracted by reversing the direction of the motor 602, which also opens the clamp arm.

In certain examples, the surgical instrument or tool may include a closure motor 603. The closing motor 603 specifically displaces the closing tube to close the anvil and transmits the closing motion generated by the motor 603 to the end effector to compress the tissue between the anvil and the staple cartridge. It may be operably coupled with a closed motor drive assembly 605 that may be configured. The closure motor 603 specifically displaces the closure tube to close the clamp arm and compresses the tissue between the clamp arm and either the ultrasonic blade or jaw member of the electrosurgical device. It may be operably coupled with a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by 603 to the end effector. The closing motion allows, for example, the end effector to transition from an open configuration to an approaching configuration to capture tissue. The end effector can be transitioned to the open position by reversing the direction of the motor 603.

In certain examples, the surgical instrument or tool may include, for example, one or more joint motion motors 606a, 606b. The motors 606a, 606b may be operably coupled to the corresponding joint motion motor drive assemblies 608a, 608b, which may be configured to transmit the joint motion generated by the motors 606a, 606b to the end effector. In certain examples, articulation allows, for example, end effectors to articulate with respect to the shaft.

As mentioned above, a surgical instrument or tool may include multiple motors that may be configured to perform a variety of independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated independently or separately to perform one or more functions while the other motors remain stationary. Can be carried out. For example, the joint movement motors 606a and 606b can be activated to jointly move the end effector while the launch motor 602 is maintained in a stopped state. Alternatively, the launch motor 602 can be activated to launch multiple staples and / or advance the cutting edge while the joint motion motor 606 is stopped. Further, the closure motor 603 may be activated at the same time as the launch motor 602 in order to advance the closure tube or closing member distally, as described in more detail below.

In certain examples, the surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In a particular example, the common control module 610 can accommodate one of a plurality of motors at a time. For example, the common control module 610 may be individually coupled and detachable to multiple motors of a robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, multiple motors of a surgical instrument or tool can be independently and selectively engaged with a common control module 610. In a particular example, the common control module 610 selectively works from one of the multiple motors of the surgical instrument or tool to the other of the multiple motors of the surgical instrument or tool. You can switch.

In at least one example, the common control module 610 selects between an operable engagement with the joint motion motors 606a, 606b and an operable engagement with either the launch motor 602 or the closure motor 603. Can be switched. In at least one embodiment, as shown in FIG. 16, switch 614 can move or transition between multiple positions and / or states. For example, at the first position 616, the switch 614 may electrically couple the common control module 610 with the launch motor 602, and at the second position 617, the switch 614 closes the common control module 610. It may be electrically coupled to the motor 603, and at the third position 618a, the switch 614 may electrically couple the common control module 610 to the first joint motion motor 606a, at the fourth position. At 618b, the switch 614 may electrically couple the common control module 610 with the second articulation motor 606b. In certain examples, separate common control modules 610 may be electrically coupled to launch motors 602, closure motors 603, and joint motion motors 606a, 606b at the same time. In a particular example, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may be provided with a torque sensor for measuring the output torque on the shaft of the motor. The force on the end effector may be sensed by any conventional method, such as by a force sensor on the outside of the jaw, or by a torque sensor on the motor that actuates the jaw.

In various examples, as shown in FIG. 16, the common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. The motor driver 626 may modulate the power transmitted from the power supply 628 to the motor coupled to the common control module 610, for example, based on the input from the microcontroller 620 (“controller”). In a particular example, as described above, the microcontroller 620 can be used, for example, to determine the current drawn by the motor while the motor is coupled to the common control module 610.

In certain examples, the microcontroller 620 may include a microprocessor 622 (“processor”) and one or more non-transitory computer-readable media or memory units 624 (“memory”). In a particular example, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform multiple functions and / or calculations described herein. it can. In certain examples, one or more of the memory units 624 may be coupled to, for example, processor 622. In various aspects, the microcontroller 620 may communicate via a wired or wireless channel, or a combination thereof.

In certain examples, the power supply 628 may be used to power, for example, the microcontroller 620. In certain examples, the power supply 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery. In certain examples, the battery pack may be configured to be detachably attached to the handle to power the surgical instrument 600. A large number of battery cells connected in series may be used as the power source 628. In certain examples, the power supply 628 may be, for example, replaceable and / or rechargeable.

In various examples, the processor 622 can control the motor driver 626 to control the position, direction of rotation, and / or speed of the motor coupled to the common control module 610. In a particular example, the processor 622 can signal the motor driver 626 to stop and / or disable the motor coupled to the common control module 610. The term "processor" as used herein combines the functionality of any suitable microprocessor, microcontroller, or central processing unit (CPU) of a computer into an integrated circuit or at most. It should be understood to include other basic computing devices integrated on several integrated circuits. Processor 622 is a versatile programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides the results as output. This is an example of sequential digital logic because it has internal memory. The processor operates on numbers and symbols represented in binary notation.

In one example, the processor 622 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In a particular example, the microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR features on-chip memory of up to 40 MHz 256 KB single-cycle flash memory or other non-volatile memory, with 40 MHz performance, among other characteristics readily available in the product datasheet. Prefetch buffer for super-improvement, 32KB single cycle SRAM, internal ROM with Non-volatile Memory® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs , ARM Cortex-M4F processor core containing one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with the module 4410. Therefore, this disclosure should not be limited to this context.

In a particular example, the memory 624 may include program instructions for controlling each motor of a surgical instrument 600 that can be coupled to a common control module 610. For example, the memory 624 may include program instructions for controlling the launch motor 602, the closure motor 603, and the joint motion motors 606a, 606b. Such program instructions can cause the processor 622 to control firing, closing, and joint motor functions according to input from an algorithm or control program of a surgical instrument or tool.

In certain examples, one or more mechanisms and / or sensors, such as the sensor 630, can be used to warn the processor 622 of program instructions to be used in a particular setting. For example, sensor 630 can warn processor 622 to use program instructions related to end effector firing, closing, and joint movement. In certain examples, the sensor 630 may include, for example, a position sensor that can be used to sense the position of the switch 614. Therefore, when the processor 622 detects, for example, through the sensor 630 that the switch 614 is in the first position 616, it uses a program instruction associated with the firing of the closing member coupled to the clamp arm of the end effector. The processor 622 can use the program instructions associated with the closure of the anvil when it detects, for example, through the sensor 630 that the switch 614 is in the second position 617. For example, if the switch 614 is detected at the third position 618a or the fourth position 618b via the sensor 630, the program instruction associated with the joint movement of the end effector can be used.

FIG. 17 is a circuit diagram of a robotic surgical instrument 700 configured to operate the surgical tools described herein according to an aspect of the present disclosure. The robotic surgical instrument 700 uses either a single or multiple joint motion drive joints to provide distal / proximal translation of displacement members, distal / proximal displacement of closed tubes, shaft rotation, and joints. It may be programmed or configured to control movement. In one aspect, the surgical instrument 700 may be programmed or configured to individually control a launching member, a closing member, a shaft member, or one or more joint motion members, or a combination thereof. The surgical instrument 700 includes a motor-driven launching member, a closing member, a shaft member, or a control circuit 710 configured to control one or more joint motion members, or a combination thereof.

In one aspect, the robotic surgical instrument 700 is connected to the clamp arm 716 and the closing member 714 portion of the end effector 702 and the ultrasonic converter 719 excited by the ultrasonic generator 721 via a plurality of motors 704a-704e. It comprises a coupled ultrasonic blade 718, a shaft 740, and a control circuit 710 configured to control one or more joint motion members 742a, 742b. The position sensor 734 may be configured to provide position feedback for the closing member 714 to the control circuit 710. The other sensor 738 may be configured to provide feedback to the control circuit 710. The timer / counter 731 provides timing and count information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and the current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.

In one aspect, the control circuit 710 is one or more microcontrollers, microprocessors, or other suitable for executing instructions that cause the processor or multiple processors to perform one or more tasks. It may be equipped with a processor. In one aspect, the timer / counter 731 provides an output signal such as elapsed time or digital count to the control circuit 710 to correlate the position of the closing member 714 determined by the position sensor 734 with the output of the timer / counter 731. As a result, the control circuit 710 can determine the position of the closing member 714 at a specific time (t) with respect to the starting position or time (t) when the closing member 714 is at a specific position with respect to the starting position. it can. The timer / counter 731 may be configured to measure elapsed time, count external events, or measure time for external events.

In one aspect, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue states. The control circuit 710 may be programmed to sense tissue conditions such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a launch control program or a closure control program based on tissue conditions. The launch control program can describe the distal motion of the displacement member. Various launch control programs can be selected to better handle different tissue conditions. For example, in the presence of thicker tissue, the control circuit 710 may be programmed to translate the displacement member at a lower speed and / or at a lower power. In the presence of thinner tissue, the control circuit 710 may be programmed to translate the displacement member at higher speed and / or higher power. The closure control program can control the closure force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the joint motion members 742a, 742b.

In one aspect, the control circuit 710 may generate a motor setpoint signal. Motor set value signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e include one or more circuits configured to provide motor drive signals to motors 704a-704e to drive motors 704a-704e, as described herein. You may. In some embodiments, the motors 704a-704e may be brushed DC electric motors. For example, the speeds of the motors 704a to 704e may be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, the respective motor drive signal being PWM provided to one or more stator windings of the motors 704a-704e. It may include a signal. Further, in some embodiments, the motor controllers 708a to 708e may be omitted, and the control circuit 710 may directly generate a motor drive signal.

In one aspect, the control circuit 710 may first operate each of the motors 704a-704e in an open-loop configuration at the first open-loop portion of the displacement member stroke. Based on the response of the robotic surgical instrument 700 during the open loop portion of the stroke, the control circuit 710 may select a launch control program with a closed loop configuration. The response of the instrument is the translational distance of the displacement member between the open loop portions, the time elapsed between the open loop portions, the energy provided to one of the motors 704a-704e during the open loop portions, the motor. The total pulse width of the drive signal may be mentioned. After the open loop portion, the control circuit 710 may implement the selected launch control program for the second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 modulates one of the motors 704a-704e in a closed-loop fashion based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. You may let me.

In one aspect, the motors 704a-704e can receive power from the energy source 712. The energy source 712 may be a main AC power source, a battery, a supercapacitor, or a DC power source driven by any other suitable energy source. The motors 704a-704e may be mechanically coupled to individual movable mechanical elements such as the closing member 714, clamp arm 716, shaft 740, joint 742a, and joint 742b via the respective transmission devices 706a-706e. Good. Transmission devices 706a-706e may include one or more gears or other coupling components for coupling motors 704a-704e to mobile mechanical elements. The position sensor 734 can sense the position of the closing member 714. The position sensor 734 may be any type of sensor capable of generating position data indicating the position of the closing member 714, or may include it. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 translates distally and proximally. The control circuit 710 may track the pulse to determine the position of the closing member 714. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors can provide other signals indicating the movement of the closing member 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a-704e is a step motor, the control circuit 710 may track the position of the closing member 714 by summing the number and directions of steps instructed by the motor 704 to perform. it can. The position sensor 734 can be located within the end effector 702 or at any other part of the instrument. Each output of the motors 704a-704e includes torque sensors 744a-744e for sensing force and has an encoder that senses the rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a launching member, such as a closing member 714 portion of the end effector 702. The control circuit 710 provides the motor control unit 708a with a motor set value, and the motor control unit 708a provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to the torque sensor 744a. The torque sensor 744a is coupled to the transmission device 706a coupled to the closing member 714. The transmission device 706a includes movable mechanical elements such as a rotating element and a launching member for controlling the movement of the closing member 714 in the distal and proximal directions along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to launch or displace the closing member 714. The position sensor 734 may be configured to provide the position of the closing member 714 or the position of the firing member along the firing stroke to the control circuit 710 as a feedback signal. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor control unit 708a. In response to the launch signal, the motor 704a drives the launch member distally along the longitudinal axis of the end effector 702 from the proximal stroke start position to the stroke end position distal to the stroke start position. be able to. As the closing member 714 translates distally, the clamp arm 716 closes towards the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to drive a closing member such as the clamp arm 716 of the end effector 702. The control circuit 710 provides a motor setting point to the motor control unit 708b that provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to the torque sensor 744b. The torque sensor 744b is coupled to the transmission device 706b coupled to the clamp arm 716. The transmission device 706b includes movable mechanical elements such as a rotating element and a closing member for controlling the movement of the clamp arm 716 from the open position and the closed position. In one aspect, the motor 704b is coupled to a closed gear assembly that includes a closed reduction gear set that is meshed with and supported by the closed spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control unit 708b. In response to the closure signal, the motor 704b advances the closure member to grip the tissue between the clamp arm 716 and the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to rotate a shaft member, such as a shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor setting point to the motor control unit 708c that provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to the torque sensor 744c. The torque sensor 744c is coupled to a transmission device 706c coupled to the shaft 740. The transmission device 706c includes movable mechanical elements such as rotating elements to control the rotation of the shaft 740 up to and beyond 360 degrees clockwise or counterclockwise. In one aspect, the motor 704c was formed (or to) on the proximal end of the proximal closure tube to be operably engaged by a rotating gear assembly operably supported on a tool mounting plate. It is coupled to a rotation transmission assembly that includes a tubular gear segment (mounted). The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotation position of the shaft 740 to the control circuit 710.

In one aspect, the control circuit 710 is configured to jointly move the end effector 702. The control circuit 710 provides a motor setting point to the motor control unit 708d that provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to the torque sensor 744d. The torque sensor 744d is coupled to a transmission device 706d coupled to the joint movement member 742a. The transmission device 706d includes movable mechanical elements such as a joint movement element for controlling the ± 65 ° joint movement of the end effector 702. In one aspect, the motor 704d is coupled to a joint motion nut, which is rotatably pivoted on the proximal end portion of the distal spine portion and joints on the proximal end portion of the distal spine portion. It is rotatably driven by the kinetic gear assembly. The torque sensor 744d provides a joint kinetic force feedback signal to the control circuit 710. The joint kinetic force feedback signal represents the joint kinetic force applied to the end effector 702. A sensor 738, such as a joint motion encoder, may provide the joint motion position of the end effector 702 to the control circuit 710.

In another aspect, the joint motor function of the robotic surgical system 700 may include two joint motor members, or joints 742a, 742b. These joint motion members 742a, 742b are driven by separate discs on a robot interface (rack) driven by two motors 708d, 708e. A separate launch motor 704a is provided to provide resistance holding motion and load to the head when the head is not in motion, and to provide joint motion when the head is in joint motion. Each of the joint motion connecting portions 742a and 742b can be driven antagonistically with respect to the other connecting portions. The joint movement members 742a and 742b are attached to the head with a fixed radius when the head rotates. Therefore, as the head rotates, the mechanical efficiency of the push-pull connection changes. This change in mechanical efficiency can be more pronounced in the drive system of other joint motion connections.

In one aspect, one or more motors 704a-704e may include a gearbox and a brushed DC motor with a mechanical connection to a launching member, closing member, or articulating member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, joint motion connections, closure tubes, and shafts. External effects are unmeasured and unpredictable effects, such as friction on tissues, surrounding bodies, and physical systems. Such external influences are sometimes referred to as drags that act against one of the electric motors 704a-704e. External influences, such as failures, can deviate the behavior of the physical system from the desired behavior of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a gyromagnetic absolute positioning system implemented as an AS5055 EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the boulder algorithm.

In one aspect, the control circuit 710 may communicate with one or more sensors 738. The sensor 738 is positioned on the end effector 702 and is adapted to work with the robotic surgical instrument 700 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. You may. The sensor 738 is one of a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an induction sensor such as a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor, and / or an end effector 702. Alternatively, any other suitable sensor for measuring two or more parameters may be provided. Sensor 738 may include one or more sensors. The sensor 738 may be placed on the clamp arm 716 to determine the position of the tissue using the divided electrodes. Torque sensors 744a-744e may be configured to sense, among other things, forces such as firing force, closing force, and / or joint kinetic force. Therefore, the control circuit 710 has (1) the closure load experienced by the distal closure tube and its position, (2) the launching member and its position in the rack, and (3) which part of the ultrasonic blade 718 is on it. It has tissue and can (4) sense loads and positions on both articular motion rods.

In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on the clamp arm 716 during the clamped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 738 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensor 738 may be configured to detect the impedance of the tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance is the thickness of the tissue located between them and / or Indicates the degree of filling.

In one aspect, the sensor 738 is, among other things, one or more limit switches, electromechanical devices, solid switches, Hall effect devices, magneto-resistive (MR) devices, giant magneto-resistive devices. , GMR) device, may be mounted as a magnetometer. In other embodiments, the sensor 738 may be mounted as a solid-state switch that operates under the influence of light, such as light sensors, IR sensors, and UV sensors, among others. Further, the switch may be a solid-state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

In one aspect, the sensor 738 may be configured to measure the force exerted on the clamp arm 716 by the closed drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the clamp arm 716 to detect the closing force applied to the clamp arm 716 by the closure tube. .. The force exerted on the clamp arm 716 may represent the tissue compression experienced by the tissue section captured between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 can be located at various points of interaction along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. One or more sensors 738 may be sampled in real time during the clamping operation by the processor of control circuit 710. The control circuit 710 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the clamp arm 716 in real time.

In one aspect, the current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as the closing member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted into a digital signal and provided to the control circuit 710. The control circuit 710 may be configured to simulate the response of the actual system of the instrument with the software of the controller. The displacement member can be actuated to move the closing member 714 in the end effector 702 at or near the target speed. The robotic surgical instrument 700 can include a feedback controller, the feedback controller being any feedback controller including, but not limited to, PID, state feedback, linear quadratic (LQR), and / or adaptive controllers. It may be any one of them. The robotic surgical instrument 700 can include a power source for converting signals from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force. .. Further details are disclosed in US Patent Application No. 15 / 636,829 entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT", filed June 29, 2017, which is incorporated herein by reference in its entirety. Has been done.

FIG. 18 shows a circuit diagram of a surgical instrument 750 configured to control the distal translation of a displacement member according to one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of the displacement member, such as the closing member 764. The surgical instrument 750 comprises an end effector 752 that may include a clamp arm 766, a closing member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and / or translation of a linear displacement member, such as the closing member 764, can be measured by an absolute positioning system, sensor mechanism, and position sensor 784. Since the closing member 764 is coupled to a longitudinally movable drive member, the position of the closing member 764 is determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Can be done. Therefore, in the following description, the position, displacement, and / or translation of the closing member 764 can be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of the displacement member, such as the closing member 764. In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or multiple processors to control a displacement member, eg, a closure member 764, in the manner described. Other suitable processors for execution may be provided. In one aspect, the timer / counter 781 provides an output signal such as elapsed time or digital count to the control circuit 760 to correlate the position of the closing member 764 determined by the position sensor 784 with the output of the timer / counter 781. As a result, the control circuit 760 can determine the position of the closing member 764 at a specific time (t) with respect to the starting position. The timer / counter 781 may be configured to measure elapsed time, count external events, or measure the time of external events.

The control circuit 760 may generate the motor set value signal 772. The motor set value signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide the motor 754 with a motor drive signal 774 to drive the motor 754, as described herein. In some embodiments, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor and the motor drive signal 774 may include PWM signals provided to one or more stator windings of the motor 754. Also, in some embodiments, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.

The motor 754 can receive power from the energy source 762. The energy source 762 may be a battery, a supercapacitor, or any other suitable energy source, or may include it. The motor 754 may be mechanically coupled to the closing member 764 via the transmission device 756. The transmission device 756 may include one or more gears or other connecting components for coupling the motor 754 to the closing member 764. The position sensor 784 can sense the position of the closing member 764. The position sensor 784 may be any type of sensor capable of generating position data indicating the position of the closing member 764, or may include it. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the closure member 764 translates distally and proximally. The control circuit 760 may track the pulse to determine the position of the closing member 764. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors can provide other signals indicating the movement of the closing member 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuit 760 can track the position of the closing member 764 by summing the number and directions of steps instructed by the motor 754 to perform. The position sensor 784 can be located within the end effector 752 or at any other part of the instrument.

The control circuit 760 can communicate with one or more sensors 788. The sensor 788 is positioned on the end effector 752 and can be adapted to work with the surgical instrument 750 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. .. The sensor 788 is one or more of induction sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or end effectors 752. Any other suitable sensor for measuring parameters may be provided. Sensor 788 may include one or more sensors.

One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on the clamp arm 766 during the clamped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect the impedance of the tissue section located between the clamp arm 766 and the ultrasonic blade 768, which impedance is the thickness of the tissue located between them and / or Indicates the degree of filling.

The sensor 788 may be configured to measure the force exerted on the clamp arm 766 by the closed drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the clamp arm 766 to detect the closing force applied to the clamp arm 766 by the closure tube. .. The force exerted on the clamp arm 766 may represent the tissue compression experienced by the tissue section captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 can be positioned at various points of interaction along the closure drive system to detect the closure force applied to the clamp arm 766 by the closure drive system. One or more sensors 788 may be sampled in real time during the clamping operation by the processor of control circuit 760. The control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the clamp arm 766 in real time.

A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the closing member 764 corresponds to the current drawn by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response of the actual system of the instrument with the software of the controller. The displacement member can be actuated to move the closing member 764 in the end effector 752 at or near the target speed. The surgical instrument 750 can include a feedback controller, the feedback controller being any one of any feedback controllers including, but not limited to, for example, PID, state feedback, LQR, and / or adaptive controllers. It may be one. The surgical instrument 750 can include a power source for converting signals from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force.

The actual drive system for the surgical instrument 750 is such that a displacement member, cutting member, or closing member 764 is driven by a brushed DC motor with a gearbox and a mechanical connection to the joint movement and / or knife system. It is configured in. Another example is, for example, an electric motor 754 that operates a displacement member of an interchangeable shaft assembly and a joint motion driver. External effects are unmeasured and unpredictable effects, such as friction on tissues, surrounding bodies, and physical systems. Such an external influence can be called an obstacle acting against the electric motor 754. External influences, such as failures, can deviate the behavior of the physical system from the desired behavior of the physical system.

Various exemplary embodiments relate to a surgical instrument 750 with an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, the motor 754 may drive the displacement members distally and proximally along the longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 located on the opposite side of the clamp arm 766. The clinician may grip the tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When ready to use the instrument 750, the clinician may provide a firing signal, for example by pressing the trigger on the instrument 750. In response to the firing signal, the motor 754 drives the displacement member distally along the longitudinal axis of the end effector 752 from the proximal stroke start position to the stroke end position distal to the stroke start position. be able to. As the displacement member translates distally, the closing member 764 with the cutting element located at the distal end can cut the tissue between the ultrasonic blade 768 and the clamp arm 766.

In various embodiments, the surgical instrument 750 comprises a control circuit 760 programmed to control the distal translation of a displacement member, such as a closure member 764, based on one or more tissue conditions. You may. The control circuit 760 may be programmed to sense tissue conditions such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on the tissue state. The control program can describe the distal movement of the displacement member. Different control programs can be selected to better handle different tissue conditions. For example, in the presence of thicker tissue, the control circuit 760 may be programmed to translate the displacement member at a lower speed and / or at a lower power. In the presence of thinner tissue, the control circuit 760 may be programmed to translate the displacement member at higher speed and / or higher power.

In some embodiments, the control circuit 760 may first operate the motor 754 in an open loop configuration with respect to the first open loop portion of the displacement member stroke. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a launch control program. The response of the instrument is the sum of the translational distance of the displacement member between the open loop portions, the time elapsed between the open loop portions, the energy provided to the motor 754 during the open loop portions, and the pulse width of the motor drive signal. And so on. After the open loop portion, the control circuit 760 may implement the selected launch control program for the second portion of the displacement member stroke. For example, during the closed loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. Further details are incorporated herein by reference in its entirety, US Patent Application No. 15 / 720,852, entitled "SYSTEM AND METHODS FOR CONTOROLRING A DISPLAY OF A SURGICAL INSTRUMENT", filed September 29, 2017. It is disclosed in.

FIG. 19 is a circuit diagram of a surgical instrument 790 configured to control various functions according to one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of the displacement member, such as the closing member 764. The surgical instrument 790 can be replaced with or interlocked with a clamp arm 766, a closing member 764, and one or more RF electrodes 796 (shown by dashed lines), an ultrasonic blade 768. It is provided with an end effector 792 which can be provided with. The ultrasonic blade 768 is coupled to an ultrasonic converter 769 driven by an ultrasonic generator 771.

In one aspect, the sensor 788 may be implemented, among other things, as a limit switch, electromechanical device, solid switch, Hall effect device, MR device, GMR device, magnetometer. In other embodiments, the sensor 638 may be a solid-state switch that operates under the influence of light, especially light sensors, IR sensors, UV sensors, and the like. Further, the switch may be a solid-state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

In one aspect, the position sensor 784 may be implemented as an absolute positioning system comprising a magnetic rotation absolute positioning system implemented as an AS5055EQFT single chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 784 can interface with the control circuit 760 to provide an absolute positioning system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the boulder algorithm.

In some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuit 760 can track the position of the closing member 764 by summing the number and directions of steps instructed by the motor to perform. The position sensor 784 can be located within the end effector 792 or at any other part of the instrument.

The control circuit 760 can communicate with one or more sensors 788. The sensor 788 is positioned on the end effector 792 and may be adapted to work with the surgical instrument 790 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. .. The sensor 788 is one or more of induction sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or end effectors 792. Any other suitable sensor for measuring parameters may be provided. Sensor 788 may include one or more sensors.

The RF energy source 794 is coupled to the end effector 792 and is provided to operate when the RF electrode 796 is provided within the end effector 792 instead of the ultrasonic blade 768 or in conjunction with the ultrasonic blade 768. When applied to the RF electrode 796. For example, the ultrasonic blade may be made of conductive metal and used as a return path for electrosurgical RF currents. The control circuit 760 controls the delivery of RF energy to the RF electrode 796.

Further details are incorporated herein by reference in their entirety, "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING US Pat. / 636,096.

Generator Hardware Adaptive Ultrasonic Blade Control Algorithm In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. Algorithms for detecting the collagen / elasticity ratio of tissue to adjust the amplitude of the distal tip of the ultrasonic blade are described in the following sections of this disclosure. Various aspects of the smart ultrasonic energy device are described herein in connection with, for example, FIGS. 1-85. Therefore, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with FIGS. 1-85 and related descriptions.

Identification of tissue type and adjustment of device parameters For certain surgical procedures, it is desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust the parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device may be adjusted based on the position of the tissue within the jaws of the ultrasonic end effector, eg, the position of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be used to identify which proportion of tissue is located at the distal or proximal end of the end effector. The reaction of the ultrasonic device may be based on the type of tissue or the compressibility of the tissue. In another aspect, the parameters of the ultrasound device may be adjusted based on the type or parameterization of the identified tissue. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be adjusted based on the ratio of collagen to the elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue can be detected using a variety of techniques, including infrared (IR) surface reflectance and emissivity. The force exerted on the tissue by the clamp arm and / or the stroke of the clamp arm to create a gap and compression. The electrical conduction of the entire jaw with electrodes can be used to determine which proportion of the jaw is covered with tissue.

FIG. 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm (s) 802 described herein with reference to FIGS. 43A-54. In another aspect, the device / appliance 235 is configured to perform the adaptive ultrasonic blade control algorithm (s) 804 described herein with reference to FIGS. 43A-54. In another aspect, both device / appliance 235 and apparatus / appliance 235 are configured to execute the adaptive ultrasonic blade control algorithms 802,804 described herein with reference to FIGS. 43A-54. Will be done.

The generator module 240 may include a patient isolation stage that communicates with the non-isolated stage via a power transformer. The secondary windings of the power transformer are housed in an insulation stage and include, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multifunctional surgery including ultrasonic and RF energy modes that can be delivered independently or simultaneously. It may include a tap configuration (eg, center tap or non-center tap configuration) for defining a drive signal output to deliver the drive signal to various surgical instruments such as instruments. Specifically, the drive signal output unit can output an ultrasonic drive signal (for example, a 420 V root mean square (RMS) drive signal) to the ultrasonic surgical instrument 241 and drives the signal. The signal output unit can output an RF electrosurgical drive signal (for example, a 100 V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 will be described herein with reference to FIGS. 21-28B.

The generator module 240, and / or device / instrument 235, are described, for example, with reference to FIGS. 8-11, eg, intelligent surgical instruments, robots, and other computers located in the operating room. It is coupled to a modular control tower 236 connected to a plurality of operating room devices such as a computer.

FIG. 21 is configured to be coupled to an ultrasonic instrument and further configured to perform an adaptive ultrasound blade control algorithm within a surgical data network with the modular communication hub shown in FIG. 20. An embodiment of the generator 900, which is a form of the vessel, is shown. The generator 900 is configured to deliver multiple energy modality to the surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, to deliver energy to the surgical instrument. The RF signal and the ultrasonic signal may be provided alone or in combination, or may be provided at the same time. As mentioned above, at least one generator output unit has multiple energy modalities (eg, ultrasound, bipolar or unipolar RF, irreversible and / or reversible electroporation, and / or microwaves, among others, through a single port. Energy) can be delivered and these signals can be delivered to the end effector individually or simultaneously to treat the tissue. The generator 900 includes a processor 902 coupled to the waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to the processor 902 (not shown for clarity of disclosure). The digital information associated with the waveform is provided to the waveform generator 904, which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is supplied to amplifier 1106 for signal conditioning and amplification. The regulated and amplified output of the amplifier 906 is coupled to the power transformer 908. The signal is coupled across the power transformer 908 to the secondary side on the patient isolated side. The first signal of the first energy modality is provided between the terminals labeled _{ENERGY 1 and RETURN of the surgical instrument.} The second signal of the second energy modality is coupled over the capacitor 910 and provided between the terminals labeled _{ENERGY 2 and RETURN of the surgical instrument.} More than two energy modality may be output, so the subscript "n" _{can be used to indicate that up to n ENERGY n} terminals can be provided, where n is greater than one. It will be understood that it is a positive integer of. It will also be appreciated that a maximum of "n" return paths (RETURN _n ) may be provided without departing from the scope of the present disclosure.

The first voltage sensing circuit 912 is _{coupled over the terminals labeled ENERGY 1} and RETURN path and measures the output voltage between them. A second voltage sensing circuit 924 is _{coupled over the terminals labeled ENERGY 2} and RETURN paths and measures the output voltage between them. The current sensing circuit 914 is arranged in series with the RETURN section on the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sensing circuit must be provided for each return interval. The output of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 is provided to the corresponding insulated transformers 916, 922, and the output of the current sensing circuit 914 is provided to another insulated transformer 918. The output of the insulated transformers 916, 928, 922 on the primary side (non-patient isolated side) of the power transformer 908 is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to processor 902 for further processing and computation. The output voltage and output feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate the output impedance among several parameters. Input / output communication between the processor 902 and the patient isolation circuit is provided through the interface circuit 920. The sensor may also telecommunications with the processor 902 via the interface circuit 920.

In one aspect, the impedance is either a first voltage sensing circuit 912 coupled over a terminal labeled _{ENERGY 1} / RETURN or a second voltage sensing circuit 924 coupled over a terminal labeled _{ENERGY 2 / RETURN.} The output can be determined by the processor 902 by dividing the output by the output of the current sensing circuit 914 arranged in series with the RETURN section on the secondary side of the power transformer 908. The output of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 is provided to the separate insulated transformers 916, 922, and the output of the current sensing circuit 914 is provided to another insulated transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to processor 902 to calculate the impedance. As an example, the first energy modality ENERGY ₁ may be ultrasonic energy and the second energy modality ENERGY ₂ may be RF energy. Nevertheless, in addition to ultrasonic energy modality and bipolar or unipolar RF energy modality, other energy modality includes irreversible and / or reversible electropiercing and / or radiofrequency energy, among others. Also, the example illustrated in FIG. 21 shows that a single return path (RETURN) can be provided for more than one energy modality, but in other embodiments, multiple return paths RETURN _n can be provided. It may be provided to each energy modality ENERGY _n. Therefore, as described herein, the impedance of the ultrasonic converter may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the tissue impedance is the first. It may be measured by dividing the output of the voltage sensing circuit 924 of 2 by the current sensing circuit 914.

As shown in FIG. 21, a generator 900 containing at least one output port can power, for example, ultrasound, bipolar or unipolar RF, irreversible and /, depending on the type of tissue treatment performed. Or a power transformer having a single output and having multiple taps to provide to the end effector in the form of one or more energy modalities such as reversible electropiercing and / or microwave energy. A vessel 908 can be included. For example, the generator 900 uses either unipolar or bipolar RF electrosurgical electrodes to drive the RF electrodes for tissue encapsulation at high voltage and low current to drive the ultrasonic converter. Therefore, energy can be delivered at low voltage and high current, or with a solidification waveform for spot solidification. The output waveform from the generator 900 can be guided, switched, or filtered to provide frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output will preferably be located between the output labeled _{ENERGY 1 and RETURN as shown in FIG.} In one embodiment, the connection of the RF bipolar electrode to the output of the generator 900 would preferably be located between the output labeled _{ENERGY 2 and RETURN.} For unipolar outputs, a preferred connection would be an active electrode (eg, pencil type or other probe) to a suitable return pad connected to the _{ENERGY 2 output and the RETURN output.}

Further details are incorporated herein by reference in their entirety, entitled "TECHNIQUES FOR OPERATING GENERATIONOR FOR DIGITALLY GENERATION ELECTRIC SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS 2017 U.S.A. It is disclosed in the issue.

As used throughout this description, the term "radio" and its derivatives describe circuits, devices, systems, methods, techniques, communication channels, etc. that can communicate data through the use of modulated electromagnetic radiation over non-solid media. May be used for. The term does not mean that the devices involved do not include any wires, but in some embodiments they may not exist. Communication modules include Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, Long Term Evolution (LTE), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS. , CDMA, TDMA, DECT, Bluetooth, their Ethernet derivatives, as well as any other radio and wired protocols designated as 3G, 4G, 5G, and beyond, but not limited to many radios. Alternatively, either a wired communication standard or a protocol may be implemented. The computing module may include a plurality of communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. May be dedicated to long-range wireless communication.

As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data stream. The term is used herein to refer to a central processor (central processing unit) within a system or computer system (particularly systems on a chip, SoC) that combines many dedicated "processors". Will be done.

As used herein, a system or system-on-chip (System or SOC) on a chip is an integrated circuit ("integrated circuit, IC" or "chip" that integrates all the components of a computer or other electronic system. Also known as). It can include digital, analog, mixed signals, and often high frequency features, all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with modern peripherals such as graphics processing units (GPUs), Wi-Fi modules, or coprocessors. The SoC may or may not include a built-in memory.

As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to the SoC, which may include a microcontroller as one of its components. The microcontroller can accommodate memory and programmable input / output peripherals along with one or more core processing units (CPUs). Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM, and small amounts of RAM are also often included on the chip. Microcontrollers can be employed for embedded applications, as opposed to personal computers or other general purpose microprocessors composed of various individual chips.

As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a connection between two parts of a computer or controller on an external device that controls the operation of the device (and its connection to the device).

Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known by the Texas Instruments ARM Cortex trade name. In one aspect, the processor, for example, on-chip memory of up to 40 MHz 256 KB single cycle flash memory or other non-volatile memory, the details of which are available in the product data sheet, for improving performance above 40 MHz. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory with StaticrisWare® software (ROM), 2KB electrically erasable programmable read-only memory (EEPROM), one or two One or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QEI) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels ), Which may be the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.

In one aspect, the processor may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options. Good.

The modular device is connected to a module that is acceptable within the surgical hub (eg, described in connection with FIGS. 3 and 9) and to various modules to connect or pair with the corresponding surgical hub. Includes surgical equipment or instruments to obtain. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, inhalers, and displays. The modular devices described herein can be controlled by control algorithms. The control algorithm is on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (eg, via a distributed computing architecture). ), Can be executed. In some examples, the control algorithm of a modular device is to the data sensed by the modular device itself (ie, by a sensor in the modular device, on the modular device, or by a sensor connected to the modular device). Control the device based on. This data may be related to the patient undergoing surgery (eg, tissue characteristics or injection pressure) or the modular device itself (eg, the speed of the knife moving forward, the motor current, or the energy level). For example, a surgical staple fastening and cutting instrument control algorithm can control the speed at which the instrument motor penetrates tissue and drives the knife based on the resistance the knife encounters as the knife advances.

FIG. 22 shows a form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used with it, wherein the surgical instrument 1104 is an ultrasonic surgical instrument. The surgical instrument 1106 is an RF electrosurgical instrument and the multifunctional surgical instrument 1108 is a combined ultrasonic / RF electrosurgical instrument. Generator 1100 can be configured for use with a variety of surgical instruments. According to various forms, the generator 1100 integrates, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the RF energy and ultrasonic energy simultaneously delivered from the generator 1100. It may be configured for use with a variety of surgical devices of various types, including the instrument 1108. In the form of FIG. 22, the generator 1100 is shown separately from the surgical instruments 1104, 1106, 1108, but in one form, the generator 1100 is any of the surgical instruments 1104, 1106, 1108. It may be formed integrally with the heel to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. The input device 1110 may include any suitable device that produces a signal suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104, which includes a handpiece 1105 (handpiece, HP), an ultrasonic converter 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 that are acoustically coupled to the ultrasonic converter 1120. The handpiece 1105 includes a trigger 1143 that operates the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c for energizing and driving the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, and 1134c can be configured to energize the ultrasonic converter 1120 using the generator 1100.

The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument, comprising a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamp arms 1142a and 1142b and returns through the conductor portion of the shaft 1127. The electrodes are coupled to a bipolar energy source within the generator 1100 and are energized by the bipolar energy source. The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142a and 1142b and an energy button 1135 for operating an energy switch for energizing the electrodes in the end effector 1124.

The generator 1100 is also configured to drive a multifunctional surgical instrument 1108. The multifunctional surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 that operates the clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, 1137c for energizing and driving the ultrasonic blade 1149 or other function. Toggle buttons 1137a, 1137b, 1137c are such that the generator 1100 is used to energize the ultrasonic converter 1120, and the bipolar energy source similarly housed in the generator 1100 is used to energize the ultrasonic blade 1149. Can be configured.

Generator 1100 can be configured for use with a variety of surgical instruments. According to various forms, the generator 1100 integrates, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the RF energy and ultrasonic energy simultaneously delivered from the generator 1100. It may be configured for use with a variety of surgical devices of various types, including the instrument 1108. In the form of FIG. 22, the generator 1100 is shown separately from the surgical instruments 1104, 1106, 1108, but in another form, the generator 1100 is of the surgical instruments 1104, 1106, 1108. It may be integrally formed with any one to form an integrated surgical system. As mentioned above, the generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. The input device 1110 may include any suitable device that produces a signal suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further embodiments of generators for digitally generating electrical signal waveforms, and surgical instruments, are described in US Patent Application Publication No. 2017-0086914-A1, which is incorporated herein by reference in its entirety. There is.

FIG. 23 is an end effector 1122 of an exemplary ultrasonic device 1104 according to at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128 that may be coupled to the ultrasonic transducer 1120 via a waveguide. As described herein, the blade 1128 can vibrate when driven by the ultrasonic transducer 1120 and can cut and / or solidify the tissue when in contact with the tissue. According to various aspects and, as illustrated in FIG. 23, the end effector 1122 may further include a clamp arm 1140 that may be configured to cooperate with the blade 1128 of the end effector 1122. Along with the blade 1128, the clamp arm 1140 may include a series of jaws. The clamp arm 1140 may be pivotally connected to the distal end of the shaft 1126 of instrument portion 1104. Clamp arm 1140 may include clamp arm tissue pads 1163 that may be formed from TEFLON® or other suitable low friction material. The pad 1163 is mounted to cooperate with the blade 1128 so that the pivotal motion of the clamp arm 1140 positions the clamp pad 1163 in a substantially parallel relationship with and in contact with the blade 1128. Can be done. With this configuration, the piece of tissue to be clamped can be gripped between the tissue pad 1163 and the blade 1128. The tissue pad 1163 may comprise a serrated configuration that includes a plurality of gripping teeth 1161s that are axially spaced apart and extend proximally to improve tissue grip in cooperation with the blade 1128. The clamp arm 1140 can transition from the open position shown in FIG. 23 to the closed position (where the clamp arm 1140 is in contact with or close to the blade 1128) in any suitable manner. For example, handpiece 1105 may include a jaw closing trigger. When activated by a clinician, the jaw closure trigger can pivot the clamp arm 1140 in any suitable manner.

The generator 1100 can be activated to provide the drive signal to the ultrasonic transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 (FIG. 24) coupled to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasonic transducer 1120 by depressing the footswitch 1430, thereby activating the ultrasonic transducer 1120 and the blade 1128. In addition to, or instead of, the footswitch 1430, some embodiments of the device 1104 may use one or more switches located on the handpiece 1105, which when activated. , The ultrasonic converter 1120 can be operated on the generator 1100. In one aspect, for example, one or more switches may include, for example, a pair of toggle buttons 1134a, 1134b, 1134c to determine the mode of operation of device 1104 (FIG. 22). For example, when the toggle button 1134a is pressed down, the ultrasonic generator 1100 can provide the maximum drive signal to the ultrasonic converter 1120 to cause the ultrasonic converter 1120 to generate the maximum ultrasonic energy output. By pressing the toggle button 1134b, the ultrasonic generator 1100 can provide a user-selectable drive signal to the ultrasonic transducer 1120, causing the ultrasonic transducer 1120 to generate less than maximum ultrasonic energy output. .. The device 1104 may additionally or alternatively include a second switch for indicating the position of the jaw closing trigger in order to operate the jaws, for example, via the clamp arm 1140 of the end effector 1122. Also, in some embodiments, the ultrasonic generator 1100 can be activated based on the position of the jaw closure trigger (eg, when the clinician pushes down on the jaw closure trigger to close the jaws via the clamp arm 1140). , Ultrasonic energy can be applied).

Further or / or one or more switches may include a toggle button 1134c that causes the generator 1100 to provide a pulse output when pressed down (FIG. 22). The pulses may be provided, for example, at any suitable frequency and classification. In certain embodiments, the power level of the pulse may be, for example, the power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.

It will be appreciated that device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (FIG. 22). For example, the device 1104 has only two toggle buttons, a toggle button 1134a for generating the maximum ultrasonic energy output and a toggle button 1134c for generating a pulse output at either the maximum or less power level each time. Can be configured to have. Thus, the drive signal output configuration of the generator 1100 may be five continuous signals, or any individual number of individual pulse signals (1, 2, 3, 4, or 5 times). In certain embodiments, the particular drive signal configuration may be controlled, for example, based on the EEPROM settings of the generator 1100 and / or the user's power level selection (s).

In certain embodiments, a two-position switch may be provided as an alternative to the toggle button 1134c (FIG. 22). For example, device 1104 may include a toggle button 1134a for generating continuous output at maximum power level and a two-position toggle button 1134b. In the first detent position, the toggle button 1134b may generate continuous output below the maximum power level, and in the second detent position, the toggle button 1134b (eg, maximum or maximum, depending on the EEPROM setting). A pulsed output may be generated (at any output level less than or equal to).

In some embodiments, the RF electrosurgical end effector 1124, 1125 (FIG. 22) may also include a pair of electrodes. The electrodes may communicate with the generator 1100, for example via a cable. Electrodes can be used, for example, to measure the impedance of tissue pieces present between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (eg, a non-therapeutic signal) to the electrodes. The impedance of the tissue piece can be found, for example, by monitoring the current, voltage, etc. of the signal.

In various aspects, the generator 1100 may include several distinct functional elements such as the modules and / or blocks shown in FIG. 24, which is a schematic representation of the surgical system 1000 of FIG. Various functional elements or modules may be configured to drive different types of surgical devices 1104, 1106, 1108. For example, the ultrasonic generator module can drive an ultrasonic device such as the ultrasonic device 1104. The electrosurgical / RF generator module can drive the electrosurgical device 1106. The module can generate the corresponding drive signal to drive the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and / or the electrosurgery / RF generator module may each be formed integrally with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (Modules are shown with virtual lines to illustrate this option). Also, in some embodiments, the electrosurgery / RF generator module may be formed integrally with the ultrasound generator module and vice versa.

According to the described embodiment, the ultrasonic generator module may generate a drive signal or a plurality of drive signals of a specific voltage, current, and frequency (eg, 55,500 cycles / second, or Hz). The drive signal or the plurality of drive signals may be provided to an ultrasonic device 1104, in particular a converter 1120 capable of operating, for example, as described above. In one aspect, the generator 1100 can be configured to generate a drive signal for a particular voltage, current, and / or frequency output signal that can be stepped with high resolution, accuracy, and reproducibility.

According to the aspects described, the electrosurgery / RF generator module uses radio frequency (RF) energy to drive signals or multiple drive signals with sufficient output power to perform bipolar electrosurgery procedures. It can generate a drive signal. In bipolar electrosurgery applications, for example, the drive signal may be provided, for example, to the electrodes of electrosurgical device 1106, as described above. Thus, the generator 1100 can be configured for therapeutic purposes by applying sufficient electrical energy to the tissue to treat the tissue (eg, coagulation, ablation, tissue welding, etc.).

The generator 1100 may include, for example, an input device 2150 (FIG. 27B) located on the front panel of the console of the generator 1100. The input device 2150 may include any suitable device that produces a signal suitable for programming the operation of the generator 1100. During operation, the user can use the input device 2150 to program the operation of the generator 1100 or otherwise control it. The input device 2150 is housed by the generator (eg, in the generator) to control the operation of the generator 1100 (eg, the operation of the ultrasonic generator module and / or the electrosurgery / RF generator module). It may include any suitable device that produces a signal that can be used (by one or more processors). In various aspects, the input device 2150 includes one or more of buttons, switches, thumbwheels, keyboards, keypads, touch screen monitors, pointing devices, remote connections to general purpose or dedicated computers. In another aspect, the input device 2150 may include a suitable user interface, such as, for example, one or more user interface screens displayed on a touch screen monitor. Thus, the input device 2150 allows the user to, for example, the current (I), voltage (V), of the drive signal or plurality of drive signals generated by the ultrasonic generator module and / or the electrosurgical / RF generator module. Various operating parameters of the generator can be set or programmed, such as frequency (f) and / or duration (T).

The generator 1100 may also include, for example, an output device 2140 (FIG. 27B) located on the front panel of the generator 1100 console. The output device 2140 includes one or more devices for providing sensory feedback to the user. Such devices may include, for example, a visual feedback device (eg, LCD display screen, LED indicator), an audible feedback device (eg, speaker, buzzer) or a tactile feedback device (eg, tactile activator).

Specific modules and / or blocks of generator 1100 may be described as examples, but more or less numbers of modules and / or blocks may be used, which may still be within the scope of the embodiment. Let's understand. Further, for ease of description, various aspects may be described with respect to the module and / or block, such module and / or block being one or more hardware components such as a processor. , Digital signal processor (DSP), programmable logic device (PLD), application specific integrated circuit (ASIC), circuits, registers and / or software components such as programs, subroutines. , Logical and / or may be implemented by a combination of hardware and software components.

In one aspect, the ultrasound generator drive module and the electrosurgery / RF drive module 1110 (FIG. 22) are one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. May include. Modules can include various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and so on. The firmware can be stored in bitmasked read-only memory (ROM) or nonvolatile memory (NVM) such as flash memory. In various implementations, the flash memory can be stored by storing the firmware in ROM. NVM can be, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or dynamic RAM (DRAM), double data rate DRAM (DRAM), and / or synchronous DRAM Other types of memory may be included, including a battery-backed random access memory (RAM) such as a DRAM).

In one aspect, the module executes program instructions for monitoring various measurable characteristics of devices 1104, 1106, 1108 and corresponds output drive signals or plurality for operating devices 1104, 1106, 1108. Includes hardware components implemented as a processor for producing output drive signals. In an embodiment in which the generator 1100 is used with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in cutting and / or coagulation mode. The electrical properties of the device 1104 and / or tissue may be measured and used to control the mode of operation of the generator 1100 and / or may be provided as feedback to the user. In an embodiment in which the generator 1100 is used with the device 1106, the drive signal may supply electrical energy (eg, RF energy) to the end effector 1124 in cutting, solidifying and / or drying modes. The electrical properties of the device 1106 and / or tissue may be measured and used to control the mode of operation of the generator 1100 and / or may be provided as feedback to the user. In various aspects, as mentioned above, the hardware components can be implemented as DSPs, PLDs, ASICs, circuits, and / or registers. In one aspect, the processor stores and executes computer software program instructions to drive various components of devices 1104, 1106, 1108, such as the ultrasonic converter 1120 and end effectors 1122, 1124, 1125. It may be configured to generate a function output signal.

Electromechanical ultrasonic systems include ultrasonic converters, waveguides, and ultrasonic blades. Electromechanical ultrasonic systems have an initial resonant frequency defined by the physical properties of the ultrasonic converter, waveguide, and ultrasonic blade. _{The ultrasonic converter is excited by an AC voltage V g} (t) and current _Ig (t) signal equal to the resonant frequency of the electromechanical ultrasonic system. When the electromechanical ultrasonic system resonates, _{the phase difference between the voltage V g} (t) signal and the current _Ig (t) signal is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, compliance with the ultrasonic blade (modeled as equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system. Therefore, the inductive impedance is no longer equal to the capacitive impedance, which causes a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system. Here the system operates "off-resonance". The mismatch between the drive frequency and the resonance frequency manifests itself as a phase difference between the _{voltage V g} (t) signal and the current _{Ig (t) signal applied to the ultrasonic transducer.} The generator electronics _{can easily monitor the phase difference between the voltage V g} (t) signal and the current _Ig (t) signal and continuously keep the drive frequency until the phase difference becomes zero again. Can be adjusted. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. Phase and / or frequency changes can be used as indirect measurements of ultrasonic blade temperature.

As shown in FIG. 25, the electromechanical properties of the ultrasonic transducer are a first branch with capacitance and a second with series-connected inductance, resistance, and capacitance that defines the electromechanical properties of the resonator. It may be modeled as an equivalent circuit that includes an "behavior" branch. Known ultrasonic generators may include an adjusting inductor to tune out the capacitance at a resonant frequency so that substantially all of the generator drive signal current flows within the operating branch. Therefore, by using a regulating inductor, the drive signal current of the generator represents the operating branch current, so that the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuned inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency fixation capability of the generator. However, the adjusting inductor must be compatible with the particular capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different capacitances require different adjusting inductors.

FIG. 25 shows an equivalent circuit 1500 of an ultrasonic converter such as an ultrasonic converter 1120 according to one aspect. Circuit 1500 has a first "working" branch with _{series-connected inductance L s} , resistance R _s , and capacitance C _s , and a second with _{capacitance C 0} , which defines the electromechanical properties of the resonator. Includes a capacitive branch of. Flows through the operating current _I m (t) is the first branch, with the current _{I g (t) ~I m (} t) flows through the capacitive branch, the driving current _I g (t) is the generator It may be received from the drive voltage V _g (t). Control of the electromechanical properties of the ultrasonic transducer may be achieved by suitably controlling _Ig (t) and V _{g (t).} As mentioned above, the known generator architecture has a _{capacitance C 0} at the resonant frequency within the parallel resonant circuit so that substantially all of the _{generator's current output Ig (t) flows through the operating branch. Can include an adjusting inductor Lt} (shown by a virtual line in FIG. 25) for tune-out. In this method, control of the operating branch current _Im (t) _{is achieved by controlling the current output Ig} (t) of the generator. The adjusting inductor L _{t is unique to the capacitance C 0} of the ultrasonic converter, but different ultrasonic converters with different static capacitances require _{different adjusting inductor L t.} Further, since the adjusting inductor L _t matches the nominal value of the _{capacitance C 0} at a single resonance frequency, _{accurate control of the operating branch current Im} (t) is guaranteed only at that frequency. Precise control of the operating branch current is compromised as the frequency drops due to the temperature of the transducer.

Various aspects of the generator 1100 may monitor the operation branch current I _{m (t)} without resorting to adjust inductor L _t. Rather, the generator 1100 applies power for a particular ultrasonic surgical device 1104 to determine the value of the _{operating branch current Im} (t) on a dynamic and ongoing basis (eg, in real time). Measurements of capacitance C ₀ between can be used (along with voltage and current feedback data of the drive signal). Thus, these aspects of the generator 1100, not only in a single resonant frequency determined by the nominal value of the capacitance C _0, or is adjusted to any value of the capacitance C ₀ at an arbitrary frequency It is possible to provide virtual tuning to simulate a resonating system.

FIG. 26 is a simplified block diagram of one aspect of the generator 1100 to provide the inductorless adjustment described above, among other advantages. 27A-27C show the architecture of the generator 1100 of FIG. 26 in one aspect. Referring to FIG. 26, the generator 1100 may include a patient isolation stage 1520 that communicates with a non-isolated stage 1540 via a power transformer 1560. The secondary winding 1580 of the power transformer 1560 is included in the insulation stage 1520 and may include a tap configuration (eg, center tap or non-center tap configuration), eg, for ultrasonic surgical equipment 1104 and electrosurgery. A drive signal output unit 1600a, 1600b, 1600c for outputting a drive signal to various surgical devices such as the device 1106 is defined. In particular, the drive signal output units 1600a, 1600b, 1600c may output a drive signal (for example, a 420V RMS drive signal) to the ultrasonic surgical apparatus 1104, and the drive signal output units 1600a, 1600b, 1600c are electric. A drive signal (eg, a 100 V RMS drive signal) may be output to the surgical device 1106, where the output unit 1600b corresponds to the center tap of the power transformer 1560. The non-insulated stage 1540 may include a power amplifier 1620 having an output section connected to the primary winding 1640 of the power transformer 1560. In certain embodiments, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic mechanism 1660 for supplying the digital output to the digital-to-analog converter (DAC) 1680, followed by the digital-to-analog converter. (DAC) 1680 supplies the corresponding analog signal to the input section of the power amplifier 1620. In certain embodiments, the programmable logic mechanism 1660 can include, for example, a field-programmable gate array (FPGA). The programmable logic mechanism 1660 controls the input of the power amplifier 1620 via the DAC1680, resulting in a number of parameters (eg, frequency, waveform shape) of the drive signal appearing in the drive signal output units 1600a, 1600b, 1600c. , Waveform amplitude) can be controlled. In certain embodiments, and as described below, along with a programmable logic mechanism 1660, a processor (eg, processor 1740 described below), many digital signal processing (DSP) -based and / or other control algorithms. Can be executed to control the parameters of the drive signal output by the generator 1100.

Power can be supplied to the bus of the power amplifier 1620 by the switch mode regulator 1700. In certain embodiments, the switch mode regulator 1700 may include, for example, an adjustable back regulator. As mentioned above, the non-insulated stage 1540 can further include a processor 1740, which, in one aspect, includes a DSP processor such as the ADSP-21469 SHARC DSP available from Analog Devices (Norwood, Mass.), For example. Can include. In certain embodiments, the processor 1740 may control the operation of the switch mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. it can. For example, in one aspect, the processor 1740 can receive the waveform envelope of a signal (eg, an RF signal) amplified by the power amplifier 1620 as an input via the ADC 1760. Processor 1740 subsequently controls the switch mode regulator 1700 (eg, via pulse width modulation (PWM) output) so that the rail voltage supplied to the power amplifier 1620 tracks the waveform envelope of the amplified signal. Can be done. By dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved compared to a fixed rail voltage amplifier scheme. Processor 1740 may be configured for wired or wireless communication.

In a particular embodiment and as described in more detail in connection with FIGS. 28A-28B, the programmable logic mechanism 1660, along with the processor 1740, directly executes a digital synthesizer (DDS) control scheme to generate. The waveform shape, frequency, and / or amplitude of the drive signal output by the device 1100 can be controlled. In one aspect, for example, the programmable logic mechanism 1660 controls the DDS by calling a waveform sample stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be built into the FPGA. Algorithm 2680 (FIG. 28A) can be executed. This control algorithm is particularly useful in ultrasonic applications where an ultrasonic converter, such as the ultrasonic converter 1120, can be driven by a distinct sinusoidal current at its resonant frequency. Minimization or reduction of the total distortion of the operating branch current can correspondingly minimize or reduce the undesired resonance effect, as other frequencies can excite the parasitic resonance. The waveform shape of the drive signal output by the generator 1100 can be influenced by various distortion sources present in the output drive circuit (eg, power transformer 1560, power amplifier 1620), and thus the voltage and current based on the drive signal. Feedback data can be input to algorithms such as the error control algorithm executed by the processor 1740, which is a dynamic, ongoing-based (eg, in real-time), LUT-stored waveform sample. Compensate for distortion by properly pre-distorting or correcting. In one aspect, the amount or degree of pre-strain applied to the LUT sample may be based on the error between the calculated operating branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this way, the pre-distorted LUT sample, when processed by the drive circuit, provides an operating branch drive signal with the desired waveform shape (eg, sinusoidal) in order to optimally drive the ultrasonic transducer. Can occur. Therefore, in such an embodiment, the LUT waveform sample is required to finally generate an operating branch drive signal of the desired waveform, taking into account the distortion effect rather than the desired waveform shape of the drive signal. Represents the waveform shape.

The non-insulated stage 1540 has an ADC 1780 and ADC 1800 can be further included. In certain embodiments, the ADC 1780 and 1800 can be configured to sample at high speeds (eg, 80 Mbps) to allow oversampling of drive signals. In one aspect, for example, the sampling rate of ADC1780, 1800 can allow oversampling of about 200 times the drive signal (depending on the drive frequency). In certain embodiments, the sampling operation of the ADC 1780 and 1800 can be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of fast sampling in the aspect of the generator 1100 is, among other things, the calculation of complex currents flowing through the operating branch, which can be used in certain embodiments to perform the DDS-based waveform shape control described above), sampled. It is possible to enable accurate digital filtering of the signal and highly accurate calculation of actual power consumption. The voltage and current feedback data output by ADC1780 and 1800 may be received and processed by a programmable logic mechanism 1660 (eg, FIFO buffering, multiplexing), eg for subsequent reads by processor 1740. In addition, it may be stored in the data memory. As mentioned above, the voltage and current feedback data can be used as input to the algorithm to pre-distort or modify the LUT waveform sample on a dynamic and progressive basis. In a particular aspect, this is in the corresponding LUT sample where each stored voltage and current feedback data pair was output by the programmable logic mechanism 1660 when the voltage and current feedback data pair was acquired. It may need to be indexed based on or otherwise associated with it. The synchronization of the LUT sample with the voltage and current feedback data in this way contributes to the accurate timing and stability of the pre-distortion algorithm.

In certain embodiments, the voltage and current feedback data can be used to control the frequency and / or amplitude (eg, current amplitude) of the drive signal. In one aspect, for example, voltage and current feedback data can be used to determine the impedance phase, eg, the phase difference between the voltage-driven signal and the current-driven signal. The frequency of the drive signal is then controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set value (eg 0 °), thereby minimizing the effect of harmonic distortion. Alternatively, it can be reduced and the impedance phase measurement accuracy can be improved accordingly. The determination of the phase impedance and the frequency control signal may be performed, for example, in the processor 1740, and the frequency control signal is supplied as an input to the DDS control algorithm executed by the programmable logic mechanism 1660.

The impedance phase can be determined by Fourier analysis. In one embodiment, the phase difference between the generator voltage V _{g (t)} drive signal and generator current I _{g (t)} drive signal, fast Fourier transform as follows (fast fourier transform, FFT) or discrete Fourier It can be determined using a transform (discrete fourier transform, DFT).

By evaluating the Fourier transform at the frequency of the sinusoidal wave, the following can be obtained.

Other approaches include weighted least squares estimation, Kalman filtering, and space vector-based techniques. Virtually all of the processing in the FFT or DFT technology may be performed within the digital domain using, for example, a 2-channel Fast ADC 1780, 1800. In one technique, digital signal samples of voltage and current signals are Fourier transformed by FFT or DFT. The phase angle φ at any time point can be calculated by the following formula:
φ = 2πft + φ ₀
In the equation, φ is the phase angle, f is the frequency, t is the time, and φ ₀ is the phase at t = 0.

Another technique for determining the phase difference between a voltage V _g (t) signal and a current _Ig (t) signal is the zero crossing method, which produces highly accurate results. If voltage V _{g (t)} signal and the current I _{g (t)} signal having the same frequency, the zero crossing of the positive from the negative voltage signal V _{g (t)} triggers the beginning of the pulse, while the current signal _{Each negative to positive zero intersection of Ig} (t) triggers the end of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a phase difference measurement. In addition, positive to negative zero intersections are used in a similar manner and the results can be averaged to reduce any effects of DC and harmonic components. In one embodiment, the analog voltage V _g (t) signal and the current _Ig (t) signal are converted to a high digital signal if the analog signal is positive and a low digital signal if the analog signal is negative. .. High-precision phase evaluation requires a rapid transition between high and low. In one aspect, a Schmitt trigger can be used with an RC stabilized network to convert an analog signal to a digital signal. In other embodiments, edge-triggered RS flip-flops and auxiliary circuits may be used. In yet another aspect, the zero crossing technique may use an eXcrusive OR (XOR) gate.

Other techniques for determining the phase difference between a voltage signal and a current signal include monitoring lithage diagrams and images, three voltmeter methods, cross-coil methods, vector voltmeters and vector impedance methods, as well as methods. Phase standard equipment, phase lock loop, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http: // www. engagebase. Use of other techniques, as described in com>, is incorporated herein by reference.

In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at the current amplitude set value. The current amplitude set value may be directly specified, or may be indirectly determined based on the specified voltage amplitude and power set value. In certain embodiments, control of the current amplitude can be performed by a control algorithm, such as a proportional calculus (PID) control algorithm within the processor 1740. Variables controlled by the control algorithm to properly control the current amplitude of the drive signal include, for example, scaling of the LUT waveform sample stored in the programmable logic mechanism 1660 and / or DAC1680 via DAC1860 (which). Can supply the input to the power amplifier 1620).

The non-isolated stage 1540 may further include a processor 1900, among other things, to provide user interface (UI) functionality. In one aspect, the processor 1900 can include, for example, an Atmel AT91 SAM9263 processor having an ARM926EJ-S core available from Atmel Corporation (San Jose, California). Examples of UI features supported by processor 1900 include auditory and visual user feedback, communication with peripherals (eg, via a universal serial bus (USB) interface), communication with footswitch 1430, and input. Communication with the device 2150 (eg, touch screen display) and communication with the output device 2140 (eg, speaker) can be mentioned. Processor 1900 can communicate with Processor 1740 and programmable logic mechanisms (eg, via the Serial Peripheral Interface (SPI) bus). Processor 1900 can primarily support UI functionality, but it can also work with processor 1740 to achieve risk mitigation in certain embodiments. For example, processor 1900 may be programmed to monitor various aspects of user input and / or other inputs (eg, touch screen input 2150, footswitch 1430 input, temperature sensor input 2160) and is erroneous. When the state is detected, the drive output of the generator 1100 can be invalidated.

In certain embodiments, both processor 1740 (FIGS. 26, 27A) and processor 1900 (FIG. 26, 27B) can determine and monitor the operating state of the generator 1100. For processor 1740, the operating state of generator 1100 can determine, for example, which control and / or diagnostic process is performed by processor 1740. For the processor 1900, the operating state of the generator 1100 can determine, for example, which element of the user interface (eg, display screen, sound) is provided to the user. Processors 1740 and 1900 can independently maintain the current operating state of the generator 1100 and recognize and evaluate possible transitions from the current operating state. Processor 1740 can act as a master in this relationship and determine when transitions between operating states occur. Processor 1900 can recognize valid transitions between operating states and can verify that a particular transition is appropriate. For example, when processor 1740 commands processor 1900 to transition to a particular state, processor 1900 can confirm that the requested transition is valid. If the transition between states requested by processor 1900 is determined to be invalid, processor 1900 may put generator 1100 into failure mode.

The non-insulated stage 1540 is a controller 1960 for monitoring the input device 2150 (eg, a capacitive touch sensor used to turn the generator 1100 on and off, a capacitive touch screen) (FIG. 26, FIG. FIG. 27B) can be further included. In certain embodiments, the controller 1960 may include at least one processor and / or other controller device that communicates with the processor 1900. In one aspect, for example, controller 1960 is a processor configured to monitor user input provided via one or more capacitive touch sensors (eg, Mega168 8 available from Atmel). A bit controller) can be provided. In one aspect, the controller 1960 can include a touch screen controller (eg, a QT5480 touch screen controller available from Atmel) for controlling and managing the acquisition of touch data from a capacitive touch screen.

In a particular embodiment, when the generator 1100 is in the "power off" state, the controller 1960 delivers operating power (eg, via a line from the power source of the generator 1100, such as power supply 2110 (FIG. 26) described below). You can continue to receive. In this way, the controller 1960 can continue to monitor the input device 2150 for turning the generator 1100 on and off (eg, a capacitive touch sensor located on the front panel of the generator 1100). When the generator 1100 is in the "power off" state, the controller 1960 can power up when it detects that the user has activated the "on / off" input device 2150 (eg, 1 of power supply 2110). Enable the operation of one or more DC / DC voltage converters 2130 (FIG. 26). As a result, the controller 1960 can initiate a sequence for transitioning the generator 1100 to the "powered on" state. Conversely, if activation of the "on / off" input device 2150 is detected while the generator 1100 is in the "power on" state, the controller 1960 is a sequence for transitioning the generator 1100 to the "power off" state. Can be started. In certain embodiments, for example, the controller 1960 can report the activation of the "on / off" input device 2150 to the processor 1900, which subsequently causes the generator 1100 to transition to the "power off" state. Executes the processing sequence required for. In such an embodiment, the controller 1960 may not have an independent capability to cause power removal from the generator 1100 after its "powered on" state has been established.

In certain embodiments, the controller 1960 can cause the generator 1100 to provide auditory or other sensory feedback to warn the user that a "power on" or "power off" sequence has begun. Such warnings may be provided at the beginning of a "power on" or "power off" sequence and before the start of other processes associated with the sequence.

In certain embodiments, the insulating step 1520 comprises, for example, a control circuit of a surgical device (eg, a control circuit with a handpiece switch) and components of the non-isolated step 1540 (eg, programmable logic mechanism 1660, processor 1740). , And / or a device interface circuit 1980 to provide a communication interface with (such as processor 1900). The instrument interface circuit 1980 provides the components and information of the non-insulated stage 1540 via a communication link that maintains an appropriate degree of electrical insulation between stages 1520 and 1540, such as an infrared (IR) based communication link. Can be exchanged. For example, a low dropout voltage regulator powered by an insulated transformer driven from the non-isolated stage 1540 can be used to power the appliance interface circuit 1980.

In one aspect, the instrument interface circuit 1980 can include a programmable logic mechanism 2000 (eg FPGA) that communicates with the signal conditioning circuit 2020 (FIGS. 26 and 27C). The signal conditioning circuit 2020 can be configured to receive a periodic signal (eg, a 2 kHz square wave) from the programmable logic mechanism 2000 to generate a bipolar call signal having the same frequency. The call signal can be generated using, for example, a bipolar current source supplied by a differential amplifier. The call signal is transmitted to the surgical device control circuit (eg, by using a conductive pair in a cable that connects the generator 1100 to the surgical device) and the state or configuration of the control circuit. Can be monitored to determine. For example, a control circuit may have one or more characteristics (eg, amplitude, etc.) of the calling signal so that the state or configuration of the control circuit can be individually identified based on one or more characteristics. A large number of switches, registers, and / or diodes may be included to modify the rectification. For example, in one aspect, the signal conditioning circuit 2020 may include an ADC for generating a sample of the voltage signal that appears between the inputs of the control circuit generated by the passage of the call signal. The programmable logic mechanism 2000 (or one component of the non-insulated step 1540) can subsequently determine the state or configuration of the control circuit based on the ADC sample.

In one aspect, the instrument interface circuit 1980 is associated with a programmable logic mechanism 2000 (or other element of the instrument interface circuit 1980), located inside the surgical device, or otherwise associated with the surgical device. A first data circuit interface 2040 can be provided that enables information exchange with the first data circuit. In certain embodiments, for example, the first data circuit 2060 is in a cable integrally attached to the handpiece of the surgical device, or an adapter for interfacing a particular surgical device type or model with the generator 1100. It may be placed inside. In certain embodiments, the first data circuit may include a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In a particular embodiment and again with reference to FIG. 26, the first data circuit interface 2040 can be implemented separately from the programmable logic mechanism 2000, with the programmable logic mechanism 2000 and the first data circuit. Suitable circuits (eg, individual logic mechanisms, processors) that allow communication between them can be provided. In another aspect, the first data circuit interface 2040 may be integral with the programmable logic mechanism 2000.

In certain embodiments, the first data circuit 2060 can store information about the particular surgical device with which the first data circuit 2060 is associated. Such information can include, for example, model numbers, serial numbers, number of operations in which the surgical device has been used, and / or other types of information. This information is read by the instrument interface circuit 1980 (eg, by the programmable logic mechanism 2000) and presented to the user via the output device 2140 and / or controls the function or operation of the generator 1100. For this purpose, it may be transferred to the components of non-isolated stage 1540 (eg, programmable logic mechanism 1660, processor 1740, and / or processor 1900). Further, any kind of information can be transmitted to the first data circuit 2060 via the first data circuit interface 2040 for storage in the first data circuit 2060 (eg, programmable). Using logic mechanism 2000). Such information can include, for example, the latest number of operations in which the surgical device has been used, and / or the date and / or time of its use.

As mentioned above, the surgical instrument may be removable from the handpiece to facilitate instrument compatibility and / or disposability (eg, instrument 1106 may be removable from handpiece 1107. May be). In such cases, known generators may have limited ability to recognize the particular instrument configuration being used and to optimize control and diagnostic processes accordingly. However, adding a readable data circuit to the surgical instrument to address this issue is problematic from a compatibility standpoint. For example, designing a surgical device to maintain backward compatibility with a generator that lacks the required data reading capabilities is impractical, for example due to different signaling schemes, design complexity, and cost. In some cases. Other aspects of the instrument economically use data circuits that can be implemented in existing surgical instruments and minimize design changes to maintain compatibility between the surgical device and modern generator platforms. Address these concerns by doing so.

Further, aspects of the generator 1100 may allow communication with instrument-based data circuits. For example, the generator 1100 may be configured to communicate with a second data circuit (eg, a data circuit) housed within a surgical instrument instrument (eg, instrument 1104, 1106, or 1108). The instrument interface circuit 1980 can include a second data circuit interface 2100 that enables this communication. In one aspect, the second data circuit interface 2100 can include a tristate digital interface, but other interfaces can also be used. In certain embodiments, the second data circuit can be generally any circuit for transmitting and / or receiving data. In one aspect, for example, a second data circuit may store information about the particular surgical instrument to which this circuit is associated. Such information can include, for example, model numbers, serial numbers, number of movements in which surgical instruments have been used, and / or any other type of information. Further or / or any kind of information can be transmitted to the second data circuit via the second data circuit interface 2100 for storage in the second data circuit (eg, programmable). Using logic mechanism 2000). Such information may include, for example, the latest number of movements in which the instrument has been used, and / or the date and / or time of its use. In certain embodiments, the second data circuit can transmit data acquired by one or more sensors (eg, appliance-based temperature sensors). In certain embodiments, the second data circuit can receive data from the generator 1100 and provide the user with a display (eg, LED display or other visible display) based on the received data.

In certain embodiments, the second data circuit and the second data circuit interface 2100 do not need to be provided with additional conductors for this purpose (eg, dedicated conductors of the cable connecting the handpiece to the generator 1100). It can be configured to achieve communication between the programmable logic mechanism 2000 and the second data circuit. In one aspect, a one-wire bus communication scheme implemented on existing cabling, for example, one of the conductors used transmits a call signal from the signal conditioning circuit 2020 to the control circuit in the handpiece. Can be used to transfer information to and from a second data circuit. In this way, any originally necessary surgical device design changes or modifications are minimized or reduced. Moreover, the presence of a second data circuit is a necessary data read, as various types of communication can be performed over common physical channels (with or without frequency band separation). It is "invisible" to non-functional generators and can therefore allow backward compatibility of surgical equipment instruments.

In certain embodiments, the isolation step 1520 can include at least one blocking capacitor 2960-1 (FIG. 27C) connected to the drive signal output section 1600b to prevent the patient from being energized with DC current. A single blocking capacitor may be required to comply with, for example, medical regulations or standards. Although failures in single capacitor designs are relatively rare, such failures can nevertheless have negative consequences. In one aspect, a second blocking capacitor 2960-2 is provided in series with the blocking capacitor 2960-1, and current leakage from a point between the blocking capacitors 2960-1 and 2960-2 is induced, for example, by leakage current. It can be monitored by an ADC 2980 for sampling the current voltage. The sample may be received, for example, by the programmable logic mechanism 2000. Based on the change in leakage current (shown by the voltage sample in the aspect of FIG. 26), the generator 1100 can determine when at least one of the blocking capacitors 2960-1 and 2960-2 has failed. Therefore, the aspect of FIG. 26 can provide benefits for a single capacitor design with a single failure point.

In certain embodiments, the non-insulated stage 1540 may include a power source 2110 for outputting DC power at suitable voltages and currents. The power supply may include, for example, a 400 W power supply for outputting a 48 VDC system voltage. As mentioned above, the power supply 2110 receives the output of the power supply and produces one or more DCs at the voltage and current required by the various components of the generator 1100. A / DC voltage converter 2130 can be further provided. As mentioned above in connection with controller 1960, one or more of the DC / DC voltage converters 2130 are when the controller 1960 detects the activation of the "on / off" input device 2150 by the user. An input may be received from the controller 1960 to enable the operation or activation of the DC / DC voltage converter 2130.

28A-28B show specific functional and structural aspects of one aspect of the generator 1100. Feedback indicating the current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADC 1780 and 1800, respectively. As shown, the ADC 1780 and 1800 can be implemented as a two-channel ADC and at high speed (eg, 80 mps) to allow oversampling of the drive signal (eg, about 200 times oversampling). The feedback signal can be sampled. Current and voltage feedback signals can be properly tuned in the analog domain prior to processing by ADC1780 and 1800 (eg amplification, filtering). Current and voltage feedback samples from ADC1780 and 1800 can be individually buffered and then multiplexed or interleaved within a single data stream within block 2120 of programmable logic mechanism 1660. In the aspects of FIGS. 28A-28B, the programmable logic mechanism 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples can be received by a parallel data acquisition port (PDAP) implemented within block 2144 of processor 1740. The PDAP can include a packing unit for performing any of the many methods for correlating a multiplexed feedback sample with a memory address. In one aspect, for example, the feedback sample corresponding to a particular LUT sample output by the programmable logic mechanism 1660 is one or more memory addresses associated with or indexed by the LUT address of the LUT sample. Can be remembered at. In another aspect, the feedback sample corresponding to a particular LUT sample output by the programmable logic mechanism 1660 can be stored in a common storage location along with the LUT address of the LUT sample. In any case, the feedback sample can be stored so that the address of the LUT sample from which a particular set of feedback samples is derived can then be confirmed. As mentioned above, synchronization of the LUT sample address and feedback sample thus contributes to the accurate timing and stability of the pre-distortion algorithm. A direct memory access (DMA) controller implemented in block 2166 of processor 1740 is a feedback sample (and arbitrary LUT sample address data where applicable) at a designated storage location 2180 (eg, internal RAM) of processor 1740. Can be memorized.

Block 2200 of processor 1740 can perform a pre-distortion algorithm to pre-distort or modify a LUT sample stored in a programmable logic mechanism 1660 on a dynamic ongoing basis. As mentioned above, the pre-distortion of the LUT sample can compensate for the various distortion sources present in the output drive circuit of the generator 1100. The pre-distorted LUT sample therefore, when processed by the drive circuit, produces a drive signal with the desired waveform shape (eg, sinusoidal) in order to optimally drive the ultrasonic transducer.

In block 2220 of the pre-distortion algorithm, the current through the operating branch of the ultrasonic transducer is determined. Operation branch currents, for example, current and voltage feedback samples (which, when suitably scaled, may represent the I _g and V _g models above in FIG. 25) stored in the storage location 2180, ultrasonic transducer Based on the value of the transducer capacitance C ₀ (measured or a priori known), and the known value of the drive frequency, it can be determined using Kirchhoff's current law. An operating branch current sample in each set of stored current and voltage feedback samples associated with the LUT sample can be determined.

In block 2240 of the pre-distortion algorithm, each operating branch current sample determined in block 2220 is compared with a sample of the desired current waveform shape to determine the difference between the samples being compared or the sample amplitude error. For this determination, a sample of the current waveform shape may be supplied from, for example, a waveform shape LUT2260 containing an amplitude sample for one cycle of the desired current waveform shape. A particular sample of the desired current waveform shape from the LUT 2260 used for comparison can be determined by the LUT sample address associated with the operating branch current sample used for comparison. Therefore, the input of the operating branch current to block 2240 can be synchronized with the input of its associated LUT sample address to block 2240. Therefore, the LUT sample stored in the programmable logic mechanism 1660 and the LUT sample stored in the waveform shape LUT2260 can have equivalent numerical values. In certain embodiments, the desired current waveform shape represented by the LUT sample stored in the waveform shape LUT2260 can be a fundamental sinusoidal wave. Other waveform shapes may be desirable. Overlapping with one or more other drive signals at other wavelengths, such as third harmonics to drive at least two mechanical resonances, for example due to lateral or other forms of beneficial vibration. It is conceivable that a basic sine wave can be used to drive the major longitudinal motion of the ultrasonic converter.

Each value of the sample amplitude error determined at block 2240, along with an index of its associated LUT address, can be transmitted to the LUT of the programmable logic mechanism 1660 (shown in block 2280 of FIG. 28A). LUT2280 (or other control block of programmable logic mechanism 1660) based on the value of the sample amplitude error and its associated address (and optionally the value of the sample amplitude error for the same LUT address received earlier). ) Can pre-distort or modify the value of the LUT sample stored in the LUT address, thereby reducing or minimizing the sample amplitude error. Such pre-distortion or correction of each LUT sample in an iterative manner over the entire range of LUT addresses will cause the output current waveform shape of the generator to be the desired current waveform shape represented by the waveform shape LUT2260 sample. It will be understood to match or match.

Current and voltage amplitude measurements, power measurements, and impedance measurements can be determined at block 2300 of processor 1740 based on current and voltage feedback samples stored in storage location 2180. Prior to determining these numbers, the feedback sample is scaled appropriately and, in certain embodiments, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components generated by the data acquisition process. be able to. The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal. In certain embodiments, the filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such an embodiment can use the Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In certain embodiments, the resulting frequency spectrum can be used to provide additional generator function. In one aspect, for example, the ratio of the second and / or third harmonic components to the fundamental frequency component can be used as a diagnostic index.

In block 2340 (FIG. 28B), a root mean square (RMS) calculation is applied to the sample size of the current feedback sample, which represents an integer of the drive signal cycle, to generate a _{measurement Irms that represents the drive signal output current.} obtain.

At block 2360, a root mean square (RMS) calculation can be applied to the sample size of the voltage feedback sample, which represents an integer of the cycle of the drive signal, to determine the _{measured value Vrms} , which represents the drive signal output voltage.

In block 2380, the current and voltage feedback samples may be one by one multiplied, average calculation is applied to samples representing the integer number of cycles of the drive signal, the measured value P _r of the actual output power of the generator is determined ..

In block 2400, the measured value _{P a} of apparent output power of the generator may be determined as the product _{V rms · I} rms.

At block 2420, the measured value Z _m of the magnitude of the load impedance can be determined as the quotient V _rms / _Irms.

In certain embodiments, blocks 2340,2360,2380,2400, and numerical _I rms is determined in _{2420, V rms, P r,} P a, and _{Z m} is any of a number of control and / or diagnostic process Can be used by generator 1100 to carry out. In certain aspects, any of these numbers may be placed in a suitable communication interface (eg, a USB interface), eg, via an output device 2140 integrated with the generator 1100, or an output device 2140 connected to the generator 1100. Can be communicated to the user through. Various diagnostic processes include, for example, handpiece integration, equipment integration, equipment mounting integration, equipment overload, equipment overload approach, poor frequency fixation, overvoltage condition, overcurrent condition, overpower condition, poor voltage sensing. , Current sensing failure, audible index failure, visual index failure, short circuit state, power supply failure, or blocking capacitor failure, but is not limited to these.

Block 2440 of processor 1740 can implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (eg, an ultrasonic converter) driven by generator 1100. As described above, the effect of harmonic distortion is affected by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set value (eg 0 °). It can be minimized or reduced to improve the accuracy of phase measurement.

The phase control algorithm receives the current and voltage feedback samples stored in storage location 2180 as inputs. Prior to using them in phase control algorithms, the feedback samples are scaled appropriately and, in certain embodiments, suitable filters 2460 (to remove noise from the data acquisition process and induced harmonic components, for example). It may be processed through the same filter 2320). The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal.

Block 2480 of the phase control algorithm determines the current through the operating branch of the ultrasonic transducer. This determination may be the same as that described above in connection with block 2220 of the pre-distortion algorithm. Therefore, the output of block 2480 can be an operating branch current sample for each set of stored current and voltage feedback samples associated with the LUT sample.

In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized inputs of the operating branch current sample and the corresponding voltage feedback sample determined in block 2480. In a particular aspect, the impedance phase is determined as the average of the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.

In block 2520 of the phase control algorithm, the impedance phase value determined in block 2220 is compared with the phase set value 2540 to determine the difference or phase error between the values to be compared.

In the phase control algorithm block 2560 (FIG. 28A), the frequency output for controlling the frequency of the drive signal is based on the value of the phase error determined by the block 2520 and the magnitude of the impedance determined by the block 2420. It is judged. In order to maintain the impedance phase determined in block 2500 at the phase set value (eg, zero phase error), the frequency output value may be continuously adjusted by block 2560 and transferred to the DDS control block 2680 (discussed below). In certain embodiments, the impedance phase can be adjusted to a 0 ° phase setting. In this way, any amount of harmonic distortion is centered around the top of the voltage waveform, improving the accuracy of phase impedance determination.

Block 2580 of processor 1740 is driven to control drive signal current, voltage, and power according to user-specified settings or requirements specified by other processes or algorithms performed by generator 1100. An algorithm for modulating the current amplitude of the signal can be implemented. Control of these numbers can be achieved, for example, by scaling the LUT sample of the LUT2280 and / or by adjusting the full-scale output voltage of the DAC1680 (which supplies the input to the power amplifier 1620) via the DAC1860. it can. Block 2600 (which, in certain embodiments, can be implemented as a PID controller) can receive current feedback samples (which can be appropriately scaled and filtered) as input from storage location 2180. The current feedback sample is compared _{to a "current demand" Id} value determined by a controlled variable (eg, current, voltage, or power) to determine if the drive signal is supplying the required current. Can be done. In embodiments the drive signal current is controlled variables, current demand _{I d} can be designated directly by the current setpoint 2620A _{(I sp).} For example, the RMS value of the current feedback data (determined by block 2340) can be compared to _{a user-specified RMS current set value I sp to determine the appropriate controller action.} For example, if the current feedback data _{shows an RMS value lower than the current set value I sp} , the LUT scaling and / or the full scale output voltage of the DAC1680 may be adjusted by the block 2600 to increase the drive signal current. Conversely, if the current feedback data _{shows an RMS value higher than the current set value I sp} , the block 2600 may adjust the LUT scaling and / or the DAC1680 full scale output voltage to reduce the drive signal current. Good.

In embodiments the driving signal voltage is the control variable, current demand I _d, for example, maintain the desired voltage set value 2620B (V _sp) when the magnitude Z _m of the measured load impedance at block 2420 is given It can be specified indirectly based on the current required to do so (eg, _Id = V _sp / Z _m ). Similarly, in an embodiment the drive signal power is controlled variables, current demand _{I d,} for example to maintain a desired power setting 2620C to _{(P sp)} when given a voltage _{V rms} measured in block 2360 Can be specified indirectly based on the current required for (eg, _Id = P _sp / V _rms ).

Block 2680 (FIG. 28A) can implement a DDS control algorithm to control the drive signal by recalling the LUT sample stored in the LUT 2280. In certain embodiments, the DDS control algorithm may be a numerically controlled oscillator (NCO) algorithm for generating waveform samples at a fixed clock rate using point (storage location) skipping techniques. The NCO algorithm can implement a phase accumulator, or frequency / phase converter, that acts as an address pointer for recalling the LUT sample from the LUT 2280. In one aspect, the phase accumulator can be a D-step size, modulo N phase accumulator, where D is a positive integer representing a frequency control value and N is the number of LUT samples in the LUT2280. For example, with the frequency control value of D = 1, for example, the phase accumulator can be made to continuously specify all the addresses of the LUT 2280, and a waveform output that duplicates the waveform stored in the LUT 2280 can be generated. If D> 1, the phase accumulator can skip the address of the LUT2280 to produce a waveform output with a higher frequency. Thereby, the frequency of the waveform generated by the DDS control algorithm can therefore be controlled by appropriately changing the frequency control value. In certain embodiments, the frequency control value can be determined based on the output of the phase control algorithm implemented in block 2440. The output of block 2680 can supply the input of DAC1680, which then supplies the corresponding analog signal to the input of power amplifier 1620.

Block 2700 of processor 1740 dynamically modulates the rail voltage of the power amplifier 1620 based on the waveform envelope of the amplified signal, thereby improving the efficiency of the power amplifier 1620, a switch mode converter control algorithm. Can be carried out. In certain embodiments, the characteristics of the waveform envelope can be determined by monitoring one or more signals contained in the power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope can be determined by monitoring the minimum value of the drain voltage (eg MOSFET drain voltage) modulated according to the envelope of the amplified signal. The minimum voltage signal can be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal is sampled by the ADC 1760 and the output minimum voltage sample may be received in block 2720 of the switch mode converter control algorithm. Based on the value of the minimum voltage sample, the block 2740 may control the PWM signal output by the PWM generator 2760, which in turn controls the rail voltage supplied to the power amplifier 1620 by the switch mode regulator 1700. .. In certain embodiments, the rail voltage can be modulated according to the waveform envelope characterized by the minimum voltage sample, as long as the value of the minimum voltage sample is less than the minimum target 2780 input to block 2720. For example, when the minimum voltage sample exhibits a low envelope power level, block 2740 supplies a low rail voltage to the power amplifier 1620, and the full rail voltage is supplied only when the minimum voltage sample exhibits a maximum envelope power level. You may. When the minimum voltage sample is below the minimum target 2780, the block 2740 may keep the rail voltage at a minimum value suitable to ensure proper operation of the power amplifier 1620.

FIG. 29 is a circuit diagram of one aspect of an electric circuit 2900 suitable for driving an ultrasonic converter such as an ultrasonic converter 1120 according to at least one aspect of the present disclosure. The electric circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A such as ultrasonic waves, batteries, and power control circuits. The current sensor 2982 is coupled in series with the return or ground section of the power supply circuit and measures the current supplied by the power supply. The field effect transistor (FET) temperature sensor 2984 provides an ambient temperature. The pulse width modulation (PWM) watchdog timer 2988 automatically causes a system reset if the main program fails to provide a periodic system reset. It is provided to automatically reset the electrical circuit 2900 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 2900 can be configured as an RF driver circuit for driving an ultrasonic converter or, for example, for driving an RF electrode such as the electrical circuit 3600 shown in FIG. Therefore, referring again to FIG. 29, the electric circuit 2900 can be used to alternately drive both the ultrasonic transducer and the RF electrode. When driven at the same time, a filter circuit may be provided in the corresponding first stage circuit 3404 (FIG. 32) to select either an ultrasonic waveform or an RF waveform. Such filtering techniques are described in co-owned US Patent Application Publication No. US-2017-0086910-A1, named "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATION", which is incorporated herein by reference in its entirety.

Drive circuit 2896 provides left and right ultrasonic energy outputs. The digital signal representing the signal waveform is supplied to the SCL-A and SDA-A inputs of the analog multiplexer 2980 from a control circuit such as the control circuit 3200 (FIG. 30). The digital / analog converter 2990 (DAC) converts the digital input into an analog output and drives the PWM circuit 2992 coupled to the oscillator 2994. The PWM circuit 2992 provides a first signal to the first gate drive circuit 2996a coupled to the first transistor output step 2998a to drive the first ultrasonic (left) energy output. The PWM circuit 2992 also provides a second signal to the second gate drive circuit 2996b coupled to the second transistor output step 2998b to drive the second ultrasonic (right) energy output. The voltage sensor 2999 is coupled between the ultrasonic left / right output terminals to measure the output voltage. The drive circuit 2896, the first drive circuit 2996a and the second drive circuit 2996b, and the first transistor output stage 2998a and the second transistor output stage 2998b define a first stage amplifier circuit. During operation, the control circuit 3200 (FIG. 30) generates a digital waveform 4300 (FIG. 37) using circuits such as the direct digital compositing (DDS) circuits 4100 and 4200 (FIGS. 35 and 36). The DAC2990 receives the digital waveform 4300, converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

FIG. 30 is a circuit diagram of a control circuit 3200 such as a control circuit 3212 according to at least one aspect of the present disclosure. The control circuit 3200 is located within the housing of the battery assembly. The battery assembly is an energy source for various local power sources 3215. The control circuit includes, for example, the main processor 3214 coupled to various downstream circuits via the interface master 3218 by the outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. Be prepared. In one embodiment, the interface master 3218 is a universal serial interface such as ^{I 2} C serial interface. The main processor 3214 also drives the switch 3224 via general purposes input / output (GPIO) 3220, the display 3226 (eg, LCD display), and various indicators 3228 via GPIO 3222. It is composed of. The watchdog processor 3216 is provided to control the main processor 3214. The switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.

In one aspect, the main processor 3214 is coupled to the electrical circuit 2900 (FIG. 29) by output terminals SCL-A, SDA-A. The main processor 3214 includes, for example, a memory for storing a table of digitized drive signals or waveforms transmitted to the electrical circuit 2900 to drive the ultrasonic converter 1120. In another aspect, the main processor 3214 may generate a digital waveform and transmit it to electrical circuit 2900, or it may store the digital waveform for later transmission to electrical circuit 2900. The main processor 3214 is also RF driven by the output terminals SCL-B, SDA-B, and various sensors by the output terminals SCL-C, SDA-C (eg, Hall effect sensor, ferrofluid (MRF) sensor, etc.). May be provided. In one aspect, the main processor 3214 is configured to sense the presence of an ultrasonic drive circuit and / or an RF drive circuit to enable suitable software and user interface functions.

In one aspect, the main processor 3214 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one example, Texas Instruments' LM4F230H5QR improves on-chip memory, performance of 256KB single-cycle flash memory up to 40MHz or other non-volatile memory, among other mechanisms readily available from product datasheets, to over 40MHz. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with Non-volatilesWare® software, 2KB electrically erasable programmable read-only memory (EEPROM), 1 One or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QED) analogs, one or more 12-bit analog-to-digital converters with 12 analog input channels An ARM Cortex-M4F processor core that includes an ADC. Other processors may be readily substituted, and therefore this disclosure should not be limited to this context.

FIG. 31 shows a simplified block schematic showing another electrical circuit 3300 housed within a modular ultrasonic surgical instrument 3334, according to at least one aspect of the present disclosure. The electric circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power supply 3304 (for example, a battery), a switch 3306 such as a metal oxide semiconductor field effect transistor (MOSFET) power supply switch, a drive circuit 3308 (PLL), a transformer 3310, and a signal. A smoothing circuit 3312 (also called a matching circuit, which can be a tank circuit, for example), a sensing circuit 3314, a converter 1120, and an ultrasonic blade (eg, an ultrasonic blade, which can also be referred to herein simply as a waveguide) Includes shaft assemblies (eg, shaft assemblies 1126, 1129) with ultrasonic transmission waveguides terminated at 1128, 1149).

Breaking Dependence on High Voltage (120VAC) Input Power (Characteristics of Common Ultrasonic Disconnectors) One feature of the disclosure is the use of low voltage switching throughout the wave forming process and just before the transformer stage. It is the amplification of the drive signal limited to. For this reason, in one aspect of the present disclosure, power is derived only from batteries or groups of batteries that are small enough to fit either within the handle assembly. State-of-the-art battery technology provides powerful batteries with a height and width of a few centimeters and a depth of a few millimeters. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasonic device, a reduction in manufacturing cost can be achieved.

The output of the power supply 3304 is supplied to the processor 3302 to supply power. The processor 3302 receives and outputs signals and also functions according to the custom logic executed by the processor 3302 or according to a computer program, as described below. As mentioned above, the electrical circuit 3300 can also include a memory 3326, preferably a random access memory (RAM), for storing computer-readable instructions and data.

The output of power supply 3304 is also directed to switch 3306, which has a duty cycle controlled by processor 3302. By controlling the on-time of the switch 3306, the processor 3302 can determine the total amount of power finally delivered to the converter 1120. In one aspect, the switch 3306 is a MOSFET, but other switches and switching configurations are similarly adaptable. The output of switch 3306 is supplied to the drive circuit 3308 including, for example, a phase detection phase-locked loop (PLL) and / or a lowpass filter and / or a voltage controlled oscillator. The output of switch 3306 is sampled by processor 3302 to determine _{the voltage and current (V IN} and I _{IN, respectively) of the output signal.} These values are used in the feedback architecture to tune the pulse width modulation of switch 3306. For example, the duty cycle of switch 3306 can vary from about 20% to about 80% depending on the desired and actual output from switch 3306.

The drive circuit 3308 that receives the signal from the switch 3306 includes an oscillator circuit that converts the output of the switch 3306 into an electrical signal having an ultrasonic frequency, for example 55 kHz (VCO). As mentioned above, this smoothed version of the ultrasonic waveform is finally fed to the ultrasonic converter 1120 to generate a resonant sine wave along the ultrasonic transmission waveguide.

At the output of drive circuit 3308, there is a transformer 3310 capable of boosting a low voltage signal (s) to a higher voltage. Note that upstream switching is performed at low (eg, battery-powered) voltage prior to transformer 3310, which until now was not possible with ultrasonic cutting and cauterizing equipment. This is due, at least in part, to the fact that the device favorably uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they generate lower switching loss and less heat than conventional MOSFET devices and can pass higher currents. Therefore, the switching stage (pre-transformer) can be characterized as low voltage / high current. To ensure a lower on-resistance of the amplifier MOSFET (s), the MOSFETs (s) are operated at, for example, 10V. In such cases, a separate 10 VDC power supply can be used to supply the MOSFET gate, ensuring that the MOSFET is completely on and a reasonably low on-resistance is achieved. In one aspect of the disclosure, the transformer 3310 boosts the battery voltage to a root mean square (RMS) of 120V. Transformers are not described in detail here as they are known in the art.

In the described circuit configuration, deterioration of circuit components can have a negative effect on the circuit performance of the circuit. One factor that directly affects the performance of components is heat. Known circuits generally monitor switching temperatures (eg MOSFET temperatures). However, due to technological advances in MOSFET design and corresponding reductions in size, MOSFET temperature is no longer a valid indicator of circuit load and heat. Therefore, according to at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because the transformer 3310 operates at or near its maximum temperature during use of the device. The additional temperature will destroy the core material, such as ferrite, which can result in permanent damage. The present disclosure of the transformer 3310, for example, by reducing the drive power in the transformer 3310, signaling the user, turning off the power, pulsing the power, or other suitable response. Can respond to the highest temperature.

In one aspect of the disclosure, the processor 3302 is communicatively coupled to an end effector (eg 1122, 1125), which arranges the material so that it is in physical contact with an ultrasonic blade (eg 1128, 1149). Used to do. The end-effector, there is provided a sensor for measuring the clamping force value (present within a known range), based on the received clamping force value, the processor 3302 changes the operating voltage V _M. The temperature sensor 3332 may be communicably coupled to the processor 3302, since a high force value combined with a set operating speed can result in a high blade temperature, where the processor 3302 is from the temperature sensor 3336 to the blade. It can operate to receive and interpret a signal indicating the current temperature and to determine the target frequency of blade motion based on the received temperature. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to a trigger (eg, 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch button so that the displacement strength corresponds to the force applied to the switch button by the user.

According to at least one aspect of the present disclosure, the PLL portion of the drive circuit 3308 coupled to the processor 3302 can determine the frequency of waveguide motion and transmit that frequency to the processor 3302. Processor 3302 stores this frequency value in memory 3326 when the device is turned off. By reading the clock 3330, the processor 3302 can determine the elapsed time since the device was shut off and, if the elapsed time is less than a predetermined value, read the last frequency of the waveguide motion. .. The device can then be started at the last frequency, which is presumably the optimum frequency for the current load.

Modular Battery-powered Handheld Surgical Instruments with Multi-Stage Generator Circuits In another aspect, the present disclosure provides modular battery-powered handheld surgical instruments with multi-stage generator circuits. Surgical instruments including battery assemblies, handle assemblies, and shaft assemblies are disclosed, which are configured to be mechanically and electrically connected to the handle assembly. The battery assembly includes a control circuit configured to generate a digital waveform. The handle assembly includes a first stage circuit configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly includes a second stage circuit coupled with a first stage circuit for receiving, amplifying and applying the analog waveform to the load device.

In one aspect, the present disclosure is a battery assembly comprising a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform. A handle assembly that includes an assembly and a first-stage circuit coupled with a processor, the first-stage circuit containing a digital-to-analog (DAC) converter and a first-stage amplifier circuit, which receives a digital waveform and is digital. The first-stage amplifier circuit is configured to receive and amplify the analog waveform, which is configured to convert the waveform to an analog waveform, and the handle assembly, which receives the analog waveform, amplifies the analog waveform, and the analog waveform. The battery assembly and shaft assembly are configured to be mechanically and electrically connected to the handle assembly, with a shaft assembly including a second stage circuit coupled to a first stage amplifier circuit for application to the load device. Provide surgical instruments that have been used.

The loading device may include any one of an ultrasonic transducer, electrodes, or sensors, or any combination thereof. The first-stage circuit may include a first-stage ultrasonic drive circuit and a first-stage high-frequency current drive circuit. The control circuit may be configured to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit individually or simultaneously. The first-stage ultrasonic drive circuit may be configured to be coupled to the second-stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to be coupled with an ultrasonic converter. The first-stage high-frequency current drive circuit may be configured to be coupled to the second-stage high-frequency drive circuit. The second stage high frequency drive circuit may be configured to be coupled to the electrodes.

The first-stage circuit may include a first-stage sensor drive circuit. The first-stage sensor drive circuit may be configured with respect to the second-stage sensor drive circuit. The second stage sensor drive circuit may be configured to be coupled to the sensor.

In another aspect, the present disclosure is a battery assembly comprising a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor being configured to generate a digital waveform. A handle assembly that includes a battery assembly and a common first-stage circuit coupled with a processor, the common first-stage circuit including a digital-to-analog (DAC) converter and a common first-stage amplifier circuit. A handle assembly that is configured to receive a digital waveform and convert the digital waveform to an analog waveform, and a common first-stage amplifier circuit that is configured to receive and amplify the analog waveform, receives the analog waveform. The battery assembly and shaft assembly are with the handle assembly, with a shaft assembly containing a second stage circuit coupled to a common first stage amplifier circuit to amplify the analog waveform and apply the analog waveform to the load device. Provided are surgical instruments that are configured to be mechanically and electrically connected.

The loading device may include any one of an ultrasonic transducer, electrodes, or sensors, or any combination thereof. Common first-stage circuits may be configured to drive ultrasonic, high frequency current, or sensor circuits. The common first-stage drive circuit may be configured to be coupled with a second-stage ultrasonic drive circuit, a second-stage high-frequency drive circuit, or a second-stage sensor drive circuit. The second-stage ultrasonic drive circuit may be configured to be coupled with an ultrasonic converter, the second-stage high-frequency drive circuit may be configured to be coupled to an electrode, and the second-stage sensor drive circuit may be configured to be coupled to a sensor. It is configured as follows.

In another aspect, the present disclosure is a control circuit comprising a memory coupled with a processor, the control circuit configured to generate a digital waveform and a common first stage circuit coupled with the processor. A common first-stage circuit that receives a handle assembly and an analog waveform that is configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly comprises a common first-stage circuit coupled with a second-stage circuit for amplification, and the shaft assembly is configured to be mechanically and electrically connected to the handle assembly. Provide surgical instruments.

Common first-stage circuits may be configured to drive ultrasonic, high frequency current, or sensor circuits. The common first-stage drive circuit may be configured to be coupled with a second-stage ultrasonic drive circuit, a second-stage high-frequency drive circuit, or a second-stage sensor drive circuit. The second-stage ultrasonic drive circuit may be configured to be coupled with an ultrasonic converter, the second-stage high-frequency drive circuit may be configured to be coupled to an electrode, and the second-stage sensor drive circuit may be configured to be coupled to a sensor. It is configured as follows.

FIG. 32 shows a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 according to at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein may include a generator circuit 3400 divided into multiple stages. For example, the surgical instrument of the surgical system 1000 is a first stage circuit of amplification that allows the operation of at least two circuits, namely RF energy only, ultrasonic energy only, and / or a combination of RF energy and ultrasonic energy. A generator circuit 3400 divided into 3404 and a second stage circuit 3406 may be provided. The combination modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 integrated with the modular shaft assembly 3414. As mentioned above throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3410 and the shaft assembly 3414 are configured to be mechanically and electrically connected to the handle assembly 3412. The end effector assembly is configured to be mechanically and electrically connected to the shaft assembly 3414.

With reference to FIG. 32, the generator circuit 3400 is divided into a plurality of stages located within a plurality of modular assemblies of surgical instruments such as the surgical instruments of the surgical system 1000 described herein. .. In one aspect, the control stage circuit 3402 may be located within the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is the control circuit 3200 described in connection with FIG. The control circuit 3200 includes a processor 3214 including an internal memory 3217 (FIG. 32) (eg, volatile and non-volatile memory) and is electrically coupled to the battery 3211. The battery 3211 supplies power to the first-stage circuit 3404, the second-stage circuit 3406, and the third-stage circuit 3408, respectively. As mentioned above, the control circuit 3200 produces a digital waveform 4300 (FIG. 37) using the circuits and techniques described in connection with FIGS. 35 and 36. With reference to FIG. 32 again, the digital waveform 4300 may be configured to drive ultrasonic transducers, radio frequency (eg, RF) electrodes, or a combination thereof, either individually or simultaneously. When driven at the same time, a filter circuit may be provided in the corresponding first stage circuit 3404 to select either an ultrasonic waveform or an RF waveform. Such filtering techniques are described in co-owned US Patent Application Publication No. US-2017-0086910-A1, named "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATION", which is incorporated herein by reference in its entirety.

The first stage circuit 3404 (eg, first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage sensor drive circuit 3424) is located within the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic drive signal to the first-stage ultrasonic drive circuit 3420 via the outputs SCL-A and SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 will be described in detail in connection with FIG. 29. The control circuit 3200 provides an RF drive signal to the first stage RF drive circuit 3422 via the outputs SCL-B and SDA-B of the control circuit 3200. The first stage RF drive circuit 3422 will be described in detail in connection with FIG. 34. The control circuit 3200 provides a sensor drive signal to the first-stage sensor drive circuit 3424 via the outputs SCL-C and SDA-C of the control circuit 3200. In general, each of the first stage circuits 3404 includes a digital / analog (DAC) converter and a first stage amplifier for driving the second stage circuit 3406. The output of the first stage circuit 3404 is provided to the input of the second stage circuit 3406.

The control circuit 3200 is configured to detect which module is plugged into the control circuit 3200. For example, the control circuit 3200 determines whether the first stage ultrasonic drive circuit 3420, the first stage RF drive circuit 3422, or the first stage sensor drive circuit 3424 located in the handle assembly 3412 is connected to the battery assembly 3410. It is configured to detect. Similarly, each of the first-stage circuits 3404 can detect which second-stage circuit 3406 is connected to it, and that information is used to determine the type of signal waveform to generate in the control circuit 3200. Returned to. Similarly, each of the second-stage circuits 3406 can detect which third-stage circuit 3408 or component is connected to it, and that information is used to determine the type of signal waveform to generate. It is returned to the control circuit 3200.

In one aspect, the second stage circuit 3406 (eg, ultrasonic driven second stage circuit 3430, RF driven second stage circuit 3432, and sensor driven second stage circuit 3434) is located within the shaft assembly 3414 of the surgical instrument. To do. The first stage ultrasonic drive circuit 3420 provides a signal to the second stage ultrasonic drive circuit 3430 via the output US left / US right. The second stage ultrasonic drive circuit 3430 can include, for example, a transformer, a filter, an amplifier, and / or a signal conditioning circuit. The first stage radio frequency (RF) current drive circuit 3422 provides a signal to the second stage RF drive circuit 3432 via the output RF left / RF right. In addition to transformers and blocking capacitors, the second stage RF drive circuit 3432 may further include filters, amplifiers, and signal conditioning circuits. The first-stage sensor drive circuit 3424 provides a signal to the second-stage sensor drive circuit 3434 via the output sensor 1 / sensor 2. The second stage sensor drive circuit 3434 may include a filter, an amplifier, and a signal conditioning circuit depending on the type of sensor. The output of the second stage circuit 3406 is provided to the input of the third stage circuit 3408.

In one aspect, the third stage circuit 3408 (eg, ultrasonic transducers 1120, RF electrodes 3074a, 3074b, and sensor 3440) may be located within various assemblies 3416 of the surgical instrument. In one aspect, the second stage ultrasonic drive circuit 3430 provides a drive signal to the piezoelectric stack of the ultrasonic transducer 1120. In one aspect, the ultrasound transducer 1120 is located within the ultrasound transducer assembly of the surgical instrument. However, in other embodiments, the ultrasonic transducer 1120 may be located within the handle assembly 3412, shaft assembly 3414, or end effector. In one aspect, the second stage RF drive circuit 3432 provides a drive signal to the RF electrodes 3074a, 3074b, which are located approximately within the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides drive signals to various sensors 3440 located throughout the surgical instrument.

FIG. 33 shows a generator circuit 3500 divided into a plurality of stages in which the first stage circuit 3504 is common to the second stage circuit 3506 according to at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein may include a generator circuit 3500 divided into multiple stages. For example, the surgical instruments of the surgical system 1000 have at least two circuits, namely radio frequency (RF) energy only, ultrasonic energy only, and / or amplifications that allow the operation of a combination of RF energy and ultrasonic energy. A generator circuit 3500 divided into a first-stage circuit 3504 and a second-stage circuit 3506 may be provided. The combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integrated with the modular shaft assembly 3514. As mentioned above throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3510 and the shaft assembly 3514 are configured to be mechanically and electrically connected to the handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect the shaft assembly 3514.

As shown in the embodiment of FIG. 33, the battery assembly 3510 portion of the surgical instrument comprises a first control circuit 3502 including the control circuit 3200 described above. The handle assembly 3512 connected to the battery assembly 3510 includes a common first stage drive circuit 3420. As mentioned above, the first stage drive circuit 3420 is configured to drive ultrasonic waves, radio frequency (RF) currents, and sensor loads. The output of the common first-stage drive circuit 3420 is a second-stage circuit 3506 such as a second-stage ultrasonic drive circuit 3430, a second-stage radio frequency (RF) current drive circuit 3432, and / or a second-stage sensor drive circuit 3434. Any one of them can be driven. The common first stage drive circuit 3420 detects which second stage circuit 3506 is located within the shaft assembly 3514 when the shaft assembly 3514 is connected to the handle assembly 3512. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 is replaced by a second stage circuit 3506 (eg, second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and / Alternatively, it is determined which one of the second stage sensor drive circuits 3434) is located within the shaft assembly 3514. This information is located within the handle assembly 3512 to supply the appropriate digital waveform 4300 (FIG. 37) to the second stage circuit 3506 to drive the appropriate load, eg, ultrasound, RF, or sensor. The control circuit 3200 is provided. It will be appreciated that various assemblies 3516 within the third stage circuit 3508, such as ultrasonic transducers 1120, electrodes 3074a, 3074b, or sensors 3440, may include identification circuits. Therefore, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

FIG. 34 is a circuit diagram of one aspect of an electrical circuit 3600 configured to drive a radio frequency current (RF) according to at least one aspect of the present disclosure. The electric circuit 3600 includes an analog multiplexer 3680. The analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A such as RF, batteries, and power control circuits. The current sensor 3682 is coupled in series with the return or ground section of the power supply circuit to measure the current supplied by the power supply. The field effect transistor (FET) temperature sensor 3864 provides the ambient temperature. The pulse width modulation (PWM) watchdog timer 3688 automatically causes a system reset if the main program fails to provide a periodic system reset. It is provided to automatically reset the electrical circuit 3600 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 can be configured, for example, to drive the RF electrodes or to drive the ultrasonic converter 1120, as described with respect to FIG. Therefore, referring again to FIG. 34, the electrical circuit 3600 can be used to drive both the ultrasonic waves and the RF electrodes alternately.

Drive circuit 3686 provides left and right RF energy outputs. The digital signal representing the signal waveform is supplied to the SCL-A and SDA-A inputs of the analog multiplexer 3680 from a control circuit such as the control circuit 3200 (FIG. 30). The digital-to-analog converter 3690 (DAC) converts a digital input into an analog output and drives a PWM circuit 3692 coupled to an oscillator 3694. The PWM circuit 3692 provides a first signal to the first gate drive circuit 3696a coupled to the first transistor output step 3698a to drive the first RF + (left side) energy output. The PWM circuit 3692 also provides a second signal to the second gate drive circuit 3696b coupled to the second transistor output step 3698b to drive the second RF (right) energy output. The voltage sensor 3699 is coupled between the RF left / RF output terminals to measure the output voltage. The drive circuit 3686, the first drive circuit 3696a and the second drive circuit 3696b, and the first transistor output stage 3698a and the second transistor output stage 3698b define a first stage amplifier circuit. During operation, the control circuit 3200 (FIG. 30) generates a digital waveform 4300 (FIG. 37) using circuits such as the direct digital compositing (DDS) circuits 4100 and 4200 (FIGS. 35 and 36). The DAC3690 receives the digital waveform 4300, converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 digitally digitizes the electrical signal waveform so that it digitizes the waveform using a predetermined number of phase points stored in the lookup table. It can be configured to occur. Phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 35 shows an aspect of a basic architecture for a digital compositing circuit such as the Direct Digital Compositing (DDS) Circuit 4100, which is configured to generate multiple waveforms for an electrical signal waveform. The generator software and digital control can instruct the FPGA to scan the address in the look-up table 4104, which in turn provides various digital input values to the DAC circuit 4108 that feeds the power amplifier. The address may be scanned according to the desired frequency. The use of such a look-up table 4104 can be supplied within the tissue, or within a transducer, RF electrode, multiple transducers, simultaneously within multiple RF electrodes, or within a combination of RF and ultrasonic instruments. , Makes it possible to generate various types of waveforms. In addition, a plurality of look-up tables 4104 representing the plurality of waveforms can be created, stored, and applied from the generator to the tissue.

The waveform signal is the output current, output voltage of the ultrasonic converter and / or RF electrode, or a plurality of them (for example, two or more ultrasonic converters and / or two or more RF electrodes). Alternatively, it may be configured to control at least one of the output powers. Further, if the surgical instrument comprises an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Thus, the generator may be configured to provide the waveform signal to at least one surgical instrument, which responds to at least one of the plurality of waveforms in the table. Note that the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may contain information related to multiple waveforms, and the table may be stored in the generator. In one embodiment or embodiment, the table may be a direct digital compositing table and may be stored in the FPGA of the generator. The table may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the table, which can be a direct digital compositing table, is addressed according to the frequency of the waveform signal. Further, the information related to the plurality of waveforms may be stored in the table as digital information.

The analog electrical signal waveform is the output current, output of the ultrasonic transducer and / or RF electrode, or a plurality of them (for example, two or more ultrasonic transducers and / or two or more RF electrodes). It may be configured to control at least one of the voltage or output power. Further, if the surgical instrument comprises an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Therefore, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, which is at least one of the plurality of waveforms stored in the look-up table 4104. Corresponds to one waveform. Note that the analog electrical signal waveforms provided for the two surgical instruments may include two or more waveforms. The look-up table 4104 may contain information related to a plurality of waveforms, and the look-up table 4104 may be stored in either the generator circuit or the surgical instrument. In one embodiment or embodiment, the lookup table 4104 may be a direct digital compositing table, which may be stored in the FPGA of the generator circuit or surgical instrument. The look-up table 4104 may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the lookup table 4104, which may be a direct digital compositing table, is addressed according to the frequency of the desired analog electrical signal waveform. Further, the information related to the plurality of waveforms may be stored in the lookup table 4104 as digital information.

With the widespread use of digital technology in instrumentation systems and communication systems, digital control methods that generate multiple frequencies from a reference frequency have evolved and are called direct digital compositing. The basic architecture is shown in FIG. In this simplified block diagram, the DDS circuit is coupled to the processor, controller, or logic mechanism of the generator circuit, and the memory circuit located within the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. The stable clock f _c is received by the address counter 4102 and the register 4106 is a programmable read-only store that stores one or more integers of a cycle of sinusoidal waves (or any other waveform) in the lookup table 4104. Drives a memory (PROM). When the address counter 4102 steps through the storage location, the value stored in the lookup table 4104 is written to the register 4106 coupled to the DAC circuit 4108. The corresponding digital amplitude of the signal at the storage location of the look-up table 4104 subsequently drives the DAC circuit 4108 to generate the analog output signal 4110. The spectral purity of the analog output signal 4110 is mainly determined by the DAC circuit 4108. Phase noise is of basically the reference clock f _c. The first analog output signal 4110 output from the DAC circuit 4108 is filtered by the filter 4112, and the second analog output signal 4114 output by the filter 4112 is an amplifier having an output coupled to the output of the generator circuit. Will be provided to. The second analog output signal has a frequency of _out .

Since the DDS circuit 4100 is a sampled data system, problems associated with sampling such as quantization noise, aliasing, and filtering must be taken into consideration. For example, the higher harmonics at the output of a phase-locked-loop (PLL) based synthesizer can be filtered, while the higher harmonics at the DAC circuit 4108 output frequency wrap to the Nyquist bandwidth. , Make them unfilterable. Look-up table 4104 contains signal data for integers of cycles. The final output frequency f _out, by changing the reference clock frequency f _c, or PROM may be changed by reprogramming.

The DDS circuit 4100 may include a plurality of look-up tables 4104, which stores a waveform represented by a predetermined number of samples, and the samples define a predetermined waveform shape. Therefore, a plurality of waveforms having a unique shape can be stored in a plurality of look-up tables 4104 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms are high crested RF electrical signal waveforms for surface tissue coagulation, low crested RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4100 can create multiple waveform look-up tables 4104, which is desired during tissue treatment procedures (eg, "on the fly" based on user or sensor inputs or in real time). Switching between the various waveforms stored in the individual look-up table 4104 can be made based on the tissue effect and / or tissue feedback of.

Therefore, switching between waveforms can be based on, for example, tissue impedance and other factors. In another aspect, the look-up table 4104 can store electrical signal waveforms (ie, trapezoidal or square waves) that are formed to maximize the power delivered into the tissue each cycle. In another aspect, the lookup table 4104 can store a synchronized waveform so that the waveform delivers RF and ultrasonic drive signals while the multifunctional surgical instrument of the surgical system 1000. Maximize power delivery by. In yet another aspect, the look-up table 4104 can store an electrical signal waveform that simultaneously drives ultrasonic and RF therapeutic and / or sub-therapeutic energy while maintaining a lock on the ultrasonic frequency. Custom waveforms specific to the various instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory of the surgical system 1000 (eg EEPROM) and are also multifunctional surgical instruments. Is fetched when connecting to the generator circuit. An example of an exponentially decaying sinusoidal curve used in many high wave high rate "coagulation" waveforms is shown in FIG.

A more flexible and effective implementation of the DDS circuit 4100 uses a digital circuit called a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and effective digital compositing circuit, such as the DDS circuit 4200, is shown in FIG. In this simplified block diagram, the DDS circuit 4200 is coupled to the processor, controller, or logic mechanism of the generator, and to a memory circuit located in either the generator or the surgical instrument of the surgical system 1000. ing. The DDS circuit 4200 includes a load register 4202, a parallel delta phase register 4204, an adder circuit 4216, a phase register 4208, a look-up table 4210 (phase-amplitude converter), a DAC circuit 4212, and a filter 4214. The adder circuit 4216 and the phase register 4208 form part of the phase accumulator 4206. Clock frequency _{f c} is applied to the phase register 4208 and the DAC circuit 4212. Load register 4202 receives an adjustment word which specifies the output frequency as a fraction of the reference clock frequency signal f _c. The output of the load register 4202 is provided to the parallel delta phase register 4204 together with the adjustment word M.

DDS circuit 4200, a sample clock for generating a clock frequency _{f c,} the phase accumulator 4206, and the look-up table 4210 (e.g., a phase - amplitude converter) including. The contents of the phase accumulator 4206, is updated once every clock cycle _{f c.} When the phase accumulator 4206 is updated, the digital number M stored in the parallel delta phase register 4204 is added to the number in the phase register 4208 by the adder circuit 4216. The number in the parallel delta phase register 4204 is 00. .. .. 01, and the initial content of the phase accumulator 4206 is 00. .. .. Assume that it is 00. The phase accumulator 4206 has a clock cycle of 00. .. .. Updated as 01. If the phase accumulator 4206 is 32-bit wide, then the phase accumulator 4206 is 00. .. .. 232 clock cycles (more than 4 billion) are required to return to 00, and the cycles are repeated.

The truncated output 4218 of the phase accumulator 4206 is provided to the lookup table 4210 of the phase-amplitude converter, and the output of the lookup table 4210 is coupled to the DAC circuit 4212. The truncated output 4218 of the phase accumulator 4206 serves as an address to a sinusoidal (or cosine) look-up table. The addresses in the look-up table correspond to the 0 ° to 360 ° phase points in the sine wave. Look-up table 4210 contains the corresponding digital amplitude information for one complete cycle of the sine wave. Therefore, the look-up table 4210 maps the phase information from the phase accumulator 4206 to the digital amplitude word, which in turn drives the DAC circuit 4212. The output of the DAC circuit is the first analog signal 4220, which is filtered by the filter 4214. The output of the filter 4214 is a second analog signal 4222 provided to a power amplifier coupled to the output of the generator circuit.

In one aspect, any suitable waveform for which the digitizable waveform is in the range 256 (28) to 281, 474, 976, 710, 656 (248) (where n is a positive integer, as shown in Table 1). Despite the number of 2n phase points, the electrical signal waveform may be digitized to 1024 (210) phase points. Electrical signal waveform may be represented as A _{n (theta n),} the amplitude A _n which is normalized at point n is represented by the phase angle theta _n, called phase point at point n. The number of individual phase points n determines the adjustment resolution of the DDS circuit 4200 (and the DDS circuit 4100 shown in FIG. 35).

Table 1 identifies the digitized electrical signal waveforms at a number of phase points.

The generator circuit algorithm and digital control circuit scan the address in the look-up table 4210, which in turn provides various digital input values to the filter 4214 and the DAC circuit 4212 that feeds the power amplifier. The address may be scanned according to the desired frequency. By using the lookup table, it is converted into an analog output signal by the DAC circuit 4212, filtered by the filter 4214, amplified by the power amplifier coupled to the output of the generator circuit, and supplied to the tissue in the form of RF energy. It is possible to generate various types of shapes that can be applied to the tissue in the form of ultrasonic vibrations that are supplied to the or ultrasonic converter and deliver energy to the tissue in the form of heat. The output of the amplifier can be applied, for example, to a single RF electrode, multiple RF electrodes at the same time, a single ultrasonic converter, multiple ultrasonic converters at the same time or a combination of RF converters and ultrasonic converters. it can. In addition, multiple waveform tables can be created, stored and applied to the tissue from the generator circuit.

Referring again to FIG. 35, for n = 32 and M = 1, the phase accumulator 4206 steps through 232 possible outputs before overflowing and restarting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. When M = 2, the phase register 1708 "rolls over" at twice the speed and the output frequency doubles. This can be generalized as follows:

In the case of a phase accumulator 4206 configured to store n-bits (n is generally in the range 24-32 in most DDS systems, but as mentioned above, n may be selected from a wide range of choices. ), There are 2 ⁿ possible phase points. The digital word M in the delta phase register represents the amount by which the phase accumulator increments with each clock cycle. If f _c is the clock frequency, the frequency of the output sine wave is equal to or less.

The above equation is known as the DDS "adjustment equation". The frequency resolution of the system

と等しいことに留意されたい。ｎ＝３２では、分解能は４０億における一部よりも高い。ＤＤＳ回路４２００の一態様では、位相アキュムレータ４２０６外の全てのビットがルックアップテーブル４２１０に伝えられるわけではなく、切り捨てられて、例えば、最初の１３〜１５個の最上位ビット（ＭＳＢ）のみが残される。これはルックアップテーブル４２１０のサイズを低減し、かつ周波数分解能に影響を及ぼさない。位相の切り捨ては、少量だが許容できる位相雑音の量のみを最終出力に追加する。

Note that is equal to. At n = 32, the resolution is higher than part of the 4 billion. In one aspect of the DDS circuit 4200, not all bits outside the phase accumulator 4206 are transmitted to the look-up table 4210 and are truncated, leaving, for example, only the first 13 to 15 most significant bits (MSB). Is done. This reduces the size of the look-up table 4210 and does not affect the frequency resolution. Phase truncation adds only a small but acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by current, voltage, or power at a given frequency. Further, if the surgical instrument of the surgical system 1000 comprises an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Therefore, the generator circuit may be configured to provide the electrical signal waveform to at least one surgical instrument, which is stored in the look-up table 4210 (or the look-up table 4104 of FIG. 35). It is characterized by a predetermined waveform. The electrical signal waveform may be a combination of two or more waveforms. The look-up table 4210 may include information related to a plurality of waveforms. In one embodiment or embodiment, the look-up table 4210 may be generated by the DDS circuit 4200 and may also be referred to directly as a digital compositing table. The DDS operates by the first storage operation of a large repetitive waveform in the onboard memory. The cycle of the waveform (sine, triangle, square, arbitrary) is represented by a predetermined number of phase points and can be stored in memory, as shown in Table 1. Once the waveform is stored in memory, it can be generated at a very accurate frequency. The direct digital synthesis table can be stored in the non-volatile memory of the generator circuit and / or implemented with the FPGA circuit in the generator circuit. The look-up table 4210 may be addressed by any suitable technique that is convenient for categorizing waveforms. According to one aspect, the look-up table 4210 is addressed according to the frequency of the electrical signal waveform. Further, the information related to the plurality of waveforms may be stored as digital information in the memory or as a part of the look-up table 4210.

In one aspect, the generator circuit may be configured to simultaneously deliver electrical signal waveforms to at least two surgical instruments. The generator circuit is also configured to provide electrical signal waveforms (which can be characterized by two or more waveforms) simultaneously to two surgical instruments via a single output channel of the generator circuit. May be done. For example, in one aspect, the electrical signal waveform includes a first electrical signal (eg, an ultrasonic drive signal) that drives an ultrasonic converter, a second RF drive signal, and / or a combination thereof. Further, the electrical signal waveform may include a plurality of ultrasonic drive signals, a plurality of RF drive signals, and / or a combination of a plurality of ultrasonic drive signals and RF drive signals.

Further, the method of operating the generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any one of the surgical instruments of the surgical system 1000. Generating an electrical signal waveform involves receiving information related to the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one waveform. Further, providing the generated electrical signal waveform to at least one surgical instrument includes simultaneously providing the electrical signal waveform to at least two surgical instruments.

The generator circuits described herein may allow the generation of various types of direct digital compositing tables. Examples of RF / electrosurgical signal waveforms generated by generator circuits that are suitable for treating various tissues include RF signals with high frequency (which can be used for surface coagulation in RF mode) and low frequency. RF signals with (which can be used for deeper tissue penetration) and waveforms that promote efficient modified coagulation can be mentioned. The generator circuit can also generate multiple waveforms directly using the digitally synthesized look-up table 4210 and can switch between specific waveforms based on the desired tissue effect on the fly. Switching may be based on tissue impedance and / or other factors.

In addition to the traditional sinusoidal / cosine waveform, the generator circuit may be configured to generate a waveform (s) (ie, trapezoidal or square wave) that maximizes power to the tissue at each cycle. If the generator circuit contains a circuit topology that allows the RF and ultrasonic signals to be driven simultaneously, then the generator circuit will be loaded when driving the RF and ultrasonic signals simultaneously. It is possible to provide a waveform (s) that are synchronized to maximize the power delivered and to maintain the ultrasonic frequency lock. In addition, custom waveforms specific to the instrument and its tissue effects can be stored in non-volatile memory (NVM) or in the EEPROM of the instrument, and any one of the surgical instruments of the surgical system 1000 is generated in the generator circuit. Can be fetched when connecting to.

The DDS circuit 4200 may include a plurality of look-up tables 4104, and the look-up table 4210 stores a waveform represented by a predetermined number of phase points (sometimes called a sample), and the phase points are predetermined waveforms. Define the shape of. Therefore, a plurality of waveforms having a unique shape can be stored in a plurality of look-up tables 4210 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms are high crested RF electrical signal waveforms for surface tissue coagulation, low crested RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4200 can create multiple waveform look-up tables 4210 as desired during tissue treatment procedures (eg, "on the fly" based on user or sensor inputs or in real time). Switching between the various waveforms stored in the various look-up tables 4210 can be made based on the tissue effect and / or tissue feedback of.

Therefore, switching between waveforms can be based on, for example, tissue impedance and other factors. In another aspect, the look-up table 4210 can store electrical signal waveforms (ie, trapezoidal or square waves) that are formed to maximize the power delivered into the tissue each cycle. In another aspect, the lookup table 4210 can store synchronized waveforms, so that when this waveform delivers RF and ultrasonic drive signals, it is among the surgical instruments of the surgical system 1000. Maximize power delivery by any one. In yet another aspect, the look-up table 4210 can store an electrical signal waveform that simultaneously drives ultrasonic and RF therapeutic and / or sub-therapeutic energy while maintaining a lock on the ultrasonic frequency. In general, the output waveform may be in the form of a sine wave, a cosine wave, a pulse wave, a square wave, or the like. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory of the surgical instrument (eg EEPROM). It can also be fetched when connecting surgical instruments to the generator circuit. An example of a custom waveform is an exponentially decaying sinusoidal waveform used in many high wave height "coagulation" waveforms, as shown in FIG.

FIG. 37 shows one cycle of the discrete-time digital electrical signal waveform 4300 according to at least one aspect of the present disclosure of the analog waveform 4304 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison purposes). The horizontal axis represents time (t) and the vertical axis represents digital phase points. The digital-electric signal waveform 4300 is, for example, a digital discrete-time version of the desired analog waveform 4304. Digital electrical signal waveform 4300, representing the amplitude of each clock cycle _{T clk} over one cycle or period _{T o,} it is generated by storing the amplitude and phase point 4302. Digital electrical signal waveform 4300, by any suitable digital processing circuitry, is generated over one period T _o. The amplitude phase point is a digital word stored in the memory circuit. In the embodiment shown in FIGS. 35 and 36, the digital word is a 6-bit word capable of storing amplitude phase points with a resolution of 26 or 64 bits. It will be appreciated that the examples shown in FIGS. 35 and 36 are for illustration purposes and the resolution can be much higher in a practical implementation. Digital amplitude phase point 4302 over one cycle _{T o} is, for example, as a string of a string word look-in up table 4104,4210, as described in connection with FIGS. 35 and 36, are stored in memory. As also described with respect to FIGS. 35 and 36, in order to generate an analog waveform 4304 of the analog version, amplitude phase point 4302 is read sequentially from memory at 0 to T _o for each clock cycle _{T clk,} And it is converted by DAC circuits 4108 and 4212. Additional cycles may be generated by reading in desired and may 0~T over cycle or period of only _o, repeated amplitude phase point 4302 of the digital electric signal waveform 4300. The smooth analog version of the analog waveform 4304 is achieved by filtering the output of DAC circuits 4108, 4212 with filters 4112, 4214 (FIGS. 35 and 36). The filtered analog output signals 4114, 4222 (FIGS. 35 and 36) are applied to the input of the power amplifier.

FIG. 38 provides gradual closure of the closing member (eg, closing tube) when the displacement member advances distally and is coupled to the clamp arm (eg, anvil) according to one aspect of the present disclosure. FIG. 5 is a diagram of a control system 12950 configured to reduce the closing force load on the closing member at a desired rate and reduce the firing force load on the launching member. In one aspect, the control system 12950 may be implemented as a nested PID feedback controller. The PID controller is a control loop feedback mechanism (controller) for continuously calculating the error value as the difference between the desired set point and the measured process variable, and is a proportional, integral, and derivative term (P, respectively). , I, and D). The nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12965. The primary controller 12952 may be a PID controller 12972 as shown in FIG. 39, and the secondary controller 12955 may also be a PID controller 12972 as shown in FIG. 39. The primary controller 12952 controls the primary process 12985 and the secondary controller 12955 controls the secondary process 12960. The output 12966 of the primary process 12985 is subtracted from the _{primary set value SP 1 by the first adder 12962.} The first adder 12962 produces a single sum output signal applied to the primary controller 12952. The output of the primary controller 12952 is the secondary setting point SP ₂ . The output 12966 of the secondary process 12960 is subtracted from the _{secondary set point SP 2 by the second adder 12964.}

In a situation where the displacement of the closed tube is controlled, the control system 12950 receives the closing force from the torque sensor coupled to the output of the closing motor, with the _{primary set value SP 1 being the desired closing force value and the primary controller 12952.} It may be configured to determine the motor speed of the closed motor set value SP _2. In other embodiments, the closing force can be measured with a strain gauge, load cell, or other suitable force sensor. The closed motor speed set value SP ₂ is compared with the actual speed of the closed tube as determined by the secondary controller 12955. The actual velocity of the closed tube can be measured by comparing the measurement of the displacement of the closed tube with a position sensor to the measurement of the elapsed time with a timer / counter. Other techniques, such as linear encoders or rotary encoders, can be used to measure the displacement of the closed tube. The output 12868 of the secondary process 12960 is the actual speed of the closed tube. This closed tube velocity output 12868 is provided to the primary process 12985, which determines the force acting on the closed tube, and is fed back to the adder 12962, which subtracts the _{measured closing force from the primary set value SP 1.} The primary set value SP ₁ may be an upper threshold value or a lower limit threshold value. Based on the output of the adder 12962, the primary controller 12952 controls the speed and direction of the closed motor. The secondary controller 12955 closes based on the actual velocity of the closed tube measured by the secondary process 12960 and the secondary set value SP _{2 based on the comparison of the actual firing force with the upper and lower thresholds of the firing force.} Control the speed of the motor.

FIG. 39 shows a PID feedback control system 12970 according to an aspect of the present disclosure. The primary controller 12952, the secondary controller 12955, or both may be implemented as the PID controller 12972. In one aspect, the PID controller 12972 may include a proportional element 12974 (P), an integrating element 12976 (I), and a differential element 12978 (D). The outputs of the P element 12974, the I element 12976, and the D element 12978 are added by the adder 12986, which provides the control variable μ (t) to process 12980. The output of process 12980 is the process variable y (t). The adder 12984 calculates the difference between the desired set value r (t) and the measured process variable y (t). The PID controller 12972 sets the error value e (eg, the closing force threshold) as the difference between the desired set point r (t) and the measured process variable y (t) (eg, the velocity and direction of the closing tube). t) (eg, the difference between the closing force threshold and the measured closing force) is continuously calculated and calculated by the proportional element 12974 (P), the integrating element 12996 (I), and the differential element 12978 (D), respectively. Apply corrections based on proportional, integral, and derivative terms. The PID controller 12972 attempts to minimize the error e (t) over time by adjusting the control variable μ (t) (eg, velocity and direction of the closed tube).

According to the PID algorithm, the "P" element 12974 causes the current value of the error. For example, when the error is large and positive, the control output is also large and positive. According to the present disclosure, the error term e (t) differs between the desired closing force of the closed tube and the measured closing force. The "I" element 12976 causes a historical value of error. For example, if the current output is not strong enough, the error integral accumulates over time and the controller responds by applying stronger motion. The "D" element 12978 is responsible for future trends in possible error, based on its current rate of change. For example, returning to the example of P above, if a large positive control output succeeds in bringing the error close to zero, it also puts the process on the path to a large negative error in the near future. In this case, the derivative becomes negative and the D module reduces the strength of motion to prevent this overshoot.

It will be appreciated that other variables and setpoints may be monitored and controlled according to the feedback control system 12950, 12970. For example, the adaptive closure member velocity control algorithms described herein include, among other things, the parameters of launch member stroke position, launch member load, cutting element displacement, cutting element velocity, closure tube stroke position, closure tube load. At least two of them can be measured.

Ultrasound surgical devices, such as scalpels, are being found in increasingly widespread use in surgical procedures due to their unique performance characteristics. With specific device configurations and operating parameters, ultrasonic surgical devices can provide homeostasis by substantially simultaneous transverse incision and coagulation of tissue, preferably minimizing patient trauma. The ultrasonic surgical device is coupled to a handpiece containing an ultrasonic transducer and an ultrasound transducer having a distally attached end effector (eg, blade tip) for cutting and sealing tissue. Can include instruments that have been used. In some cases, the device can be permanently attached to the handpiece. In other cases, the device can be removable from the handpiece, as in the case of disposable or replaceable devices. The end effector transfers ultrasonic energy to the tissue in contact with the end effector to achieve cutting and sealing action. Such ultrasonic surgical devices can be configured for open surgery applications, laparoscopic or endoscopic surgery including robot-assisted surgery.

Ultrasonic energy can be transferred to the end effector by an ultrasonic generator that cuts and coagulates tissue using lower temperatures than those used in electrosurgical procedures and communicates with the handpiece. The ultrasonic blade vibrates at high frequencies (eg, 55,500 cycles per second) to denature proteins in tissue to form sticky clots. When pressure is applied to the tissue by the blade surface, the blood vessels collapse, allowing the clot to form a hemostatic seal. The surgeon can control the cutting rate and coagulation due to the force applied to the tissue by the end effector, the time the force is applied, and the execution level of the end effector selected.

The ultrasonic transducer is modeled as an equivalent circuit that includes a first branch with capacitance, a second "working" branch with series-connected inductance, resistance, and capacitance that defines the electromechanical properties of the resonator. Can be transformed into. Known ultrasonic generators may include a tuning inductor for tuning out the capacitance at a resonant frequency so that substantially all of the generator drive signal current flows within the operating branch. Therefore, by using a regulating inductor, the drive signal current of the generator represents the operating branch current, so that the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuned inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency fixation capability of the generator. However, the adjusting inductor must be compatible with the particular capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different capacitances require different adjusting inductors.

In addition, in some ultrasonic generator structures, the generator drive signal exhibits asymmetric harmonic distortion that complicates impedance scale and phase measurements. For example, the accuracy of impedance phase measurements can be reduced by harmonic distortion of current and voltage signals.

Moreover, electromagnetic interference in a noisy environment reduces the generator's ability to maintain a fixed resonant frequency of the ultrasonic converter and increases the likelihood of invalid control algorithm inputs.

Electrosurgical devices for applying electrical energy to tissue to treat and / or destroy tissue have also been found in increasingly widespread use in surgical procedures. Electrosurgical instruments can include instruments with handpieces and distally attached end effectors (eg, one or more electrodes). The end effector can be positioned relative to the tissue so that current is introduced into the tissue. The electrosurgical device can be configured for bipolar or unipolar operation. During bipolar operation, each current is introduced into the tissue by the working electrode of the end effector and returned from the tissue by the return electrode of the end effector. During unipolar operation, current is introduced into the tissue by the active electrode of the end effector and is returned via a return electrode (eg, ground pad) that is located separately on the patient's body. The heat generated by the current flowing through the tissue may form a hemostatic seal within and / or between the tissues, and thus may be particularly useful, for example, to seal a blood vessel. The end effector of the electrosurgical device may also include a cutting member that is movable with respect to the tissue and electrodes for making a transverse incision in the tissue.

The electrical energy applied by the electrosurgical device can be transferred to the instrument by a generator that communicates with the handpiece. Electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range of 300 kHz to 1 MHz, as described in EN60601-2-2: 2009 + A11: 2011, Definition 2011.3.218-HIGH FREENCY. For example, frequencies in unipolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be of almost any value. Frequencies above 200 kHz are typically used in unipolar applications to avoid unnecessary nerve and muscle irritation resulting from the use of low frequency currents. Lower frequencies can be used for bipolar techniques if risk analysis shows that the potential for neuromuscular stimulation has been mitigated to acceptable levels. Frequencies above 5 MHz are typically not used to minimize problems associated with high frequency leakage currents. Generally, 10 mA is recognized as the lower threshold of thermal effect on tissue.

During its operation, the electrosurgical device can transfer low frequency RF energy through the tissue, which causes ionic agitation or friction, or resistance heating, which raises the temperature of the tissue. A clear boundary can be formed between the tissue to be treated and the surrounding tissue, allowing the surgeon to perform surgery with a high level of accuracy and control without sacrificing adjacent non-target tissue. The low operating temperature of RF energy can be useful in simultaneously sealing blood vessels while removing, contracting, or engraving soft tissue. RF energy can work particularly well on connective tissue, which is composed primarily of collagen and contracts when in contact with heat.

Due to the need for these unique drive signals, sensing and feedback, ultrasonic and electrosurgical devices generally required different generators. In addition, if the instruments are disposable or compatible with handpieces, ultrasonic and electrosurgical generators recognize the particular instrument configuration used and therefore optimize those for control and diagnostic processes. Ability is limited. Moreover, the capacitive coupling between the generator's non-insulated circuit and the patient's insulated circuit can result in exposing the patient to unacceptable levels of leakage current, especially when higher voltages and frequencies are used.

Moreover, due to the need for these unique drive signals, sensing and feedback, ultrasonic and electrosurgical devices have generally required different user interfaces for different generators. In these conventional ultrasonic and electrosurgical devices, one user interface may be configured for use with an ultrasonic instrument, while another user interface may be configured for use with an electrosurgical instrument. is there. Such user interfaces include hand and / or foot-activated user interfaces such as hand-activated switches and / or foot-activated switches. Various aspects of combined generators for use with both ultrasound and electrosurgical instruments are conceived in subsequent disclosures and thus work with both ultrasound and / or electrosurgical instrument generators. Additional user interfaces configured as such are also considered.

An additional user interface for providing feedback to either the user or any other machine to provide feedback indicating the mode or state of operation of any of the ultrasound and / or electrosurgical instruments will be provided in the subsequent disclosure. Will be considered. Providing user and / or mechanical feedback for manipulating a combination of ultrasound and / or electrosurgical instruments provides sensory feedback to the user and provides electrical / mechanical / electromechanical feedback to the machine. Need to do. A visual feedback device (eg, LCD display screen, LED indicator), an audible feedback device (eg, speaker, buzzer), or a tactile feedback device (eg, eg, for use with combined ultrasonic and / or electrosurgical instruments). Feedback devices incorporating tactile actuators) will be considered in subsequent disclosures.

Other electrosurgical instruments include, but are not limited to, irreversible and / or reversible electroporation and / or microwave technology. Therefore, the techniques disclosed herein apply, among other things, to ultrasound, bipolar or unipolar RF (electrosurgical), irreversible and / or reversible electroperforation, and / or microwave-based surgical instruments. It is possible.

Various aspects are intended for improved ultrasonic surgical equipment, electrosurgical equipment, and generators for use with them. Aspects of ultrasonic surgical devices can be configured, for example, to transversely incis and / or coagulate tissue during a surgical procedure. Aspects of electrosurgical devices can be configured, for example, to transversely incis, coagulate, scale, weld and / or dry tissue during a surgical procedure.

The generator aspect uses high-speed analog-digital sampling of the generator drive signal current and voltage (eg, oversampling approximately 200 times depending on the frequency), along with digital signal processing, and often outperforms known generator architectures. Provides the benefits and benefits of. In one aspect, the generator may determine the operating branch current of the ultrasonic converter based on, for example, current and voltage feedback data, the capacitance value of the ultrasonic converter, and the drive signal frequency value. This substantially provides the benefits of tuned system, the capacitance at any frequency (e.g., C ₀ in FIG. ₂₅₎ simulates the existence of a system for or resonant tuned with any of the value of bets To do. Therefore, control of the operating branch current can be achieved by tune out the capacitance effect without the need for a regulating inductor. In addition, the elimination of the regulating inductor may not impair the frequency fixing capability of the generator, as frequency fixing can be achieved by appropriately processing the current and voltage feedback data.

Fast analog-digital sampling of generator drive signal currents and voltages with digital signal processing can also allow accurate digital filtering of samples. For example, the generator aspect uses a low-pass digital filter (eg, a finite impulse response (FIR) filter) that rolls off between the fundamental drive signal frequency and the second harmonics of the current and voltage feedback samples. Asymmetric harmonic distortion and EMI induction noise may be reduced. The filtered current and voltage feedback samples effectively represent the fundamental drive signal frequency, thus allowing for more accurate impedance phase measurements with respect to the fundamental drive signal frequency and an improvement in the generator's ability to maintain a fixed resonant frequency. To. The accuracy of the impedance phase measurement can be further improved by averaging the falling edge and rising edge phase measurements and adjusting the measured impedance phase to 0 °.

Various aspects of the generator can also use high-speed analog-digital sampling of the generator drive signal current and voltage, along with digital signal processing, to determine actual power consumption and other quantities with high accuracy. This is useful in many ways, such as controlling the amount of power that the generator supplies to the tissue as the tissue impedance changes, and controlling the power supply to maintain a constant rate of increase in tissue impedance. It may be possible to execute various algorithms. Some of these algorithms are used to determine the phase difference between the generator drive signal current and the voltage signal. At resonance, the phase difference between the current signal and the voltage signal is zero. The phase changes when the ultrasonic system goes off-resonance. Various algorithms may be used to detect the phase difference and adjust the drive frequency until the ultrasonic system returns to resonance, i.e., the phase difference between the current and voltage signals is zero. The phase information may also be used to estimate the state of the ultrasonic blade. As described in detail below, the phase changes as a function of the temperature of the ultrasonic blade. Therefore, the phase information may be used to control the temperature of the ultrasonic blade. This, for example, reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at an excessively high temperature, and delivers it to the ultrasonic blade when the ultrasonic blade is operating at an excessively low temperature. It can be done by increasing the power generated.

Various aspects of the generator may have a wide frequency range and increased output power required to drive both ultrasonic and electrosurgical devices. The lower voltage, higher current demands of electrosurgical equipment may be met by dedicated taps on wideband power transformers, thus eliminating the need for separate power amplifiers and output transducers. In addition, the generator sensing and feedback circuitry can support a large dynamic range to meet the needs of both minimal distortion ultrasound and electrosurgical applications.

Various aspects are known by the generator being a data circuit (eg, trade name "1-Wire") placed within the instrument attached to the handpiece using an existing multi-conductor generator / handpiece cable. It may provide a simple and economical means for reading from and optionally writing to a single wire bus device, such as a 1-wire protocol EEPROM. In this way, the generator can read and process data specific to the device from the device attached to the handpiece. This may allow the generator to provide better control and improved diagnostic and error detection. In addition, the ability of the generator to write data to the instrument gives rise to possible new functionality, for example, in tracking instrument use and capturing motion data. In addition, the use of frequency bands allows backward compatibility of appliances, including bus devices for existing generators.

The disclosed aspects of the generator provide active elimination of leakage current caused by unintended capacitive coupling between the generator's non-insulated circuit and the patient's insulated circuit. In addition to reducing patient risk, reducing leakage current can also reduce electromagnetic radiation.

FIG. 40 is a system diagram 7400 of a segmented circuit 7401 with a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 according to at least one aspect of the present disclosure. The circuit segment of the plurality of circuit segments of the segmented circuit 7401 is a set of one or more circuits and one or more machine-executable instructions stored in one or more memory devices. And, including. One or more circuits in a circuit segment are coupled for telecommunications through one or more wired or wireless connection media. The plurality of circuit segments are configured to transition between three modes, including sleep mode, standby mode and operation mode.

In one aspect shown, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 first start in standby mode, secondly enter sleep mode, and thirdly operate mode. Move to. However, in other embodiments, the plurality of circuit segments can transition from any one of the three modes to any other one of the three modes. For example, a plurality of circuit segments can directly transition from standby mode to operating mode. The individual circuit segments may be placed in a particular state by the voltage control circuit 7408 based on the processor execution of machine executable instructions. These states include a non-energized state, a low energy state and an energized state. The non-energized state corresponds to the sleep mode, the low energy state corresponds to the standby mode, and the energized state corresponds to the operation mode. The transition to the low energy state can be achieved, for example, by using a potentiometer.

In one aspect, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 can transition from sleep mode or standby mode to operation mode according to the energization sequence. The plurality of circuit segments can also transition from the operating mode to the standby mode or the sleep mode according to the non-energized sequence. The energized sequence and the non-energized sequence may be different. In some embodiments, the energization sequence comprises energizing only a subset of the circuit segments of the plurality of circuit segments. In some embodiments, the non-energized sequence comprises stopping energization of only a subset of the circuit segments of the plurality of circuit segments.

With reference to system FIG. 7400 of FIG. 40 again, segmentation circuit 7401 includes transition circuit segment 7402, processor circuit segment 7414, handle circuit segment 7416, communication circuit segment 7420, display circuit segment 7424, motor control circuit segment 7428, energy treatment. It comprises a plurality of circuit segments, including a circuit segment 7434 and a shaft circuit segment 7440. The transition circuit segment comprises a wakeup circuit 7404, a boost current circuit 7406, a voltage control circuit 7408, a safety controller 7410, and a POST controller 7412. Transitional circuit segment 7402 is configured to implement de-energized and energized sequences, safety detection protocols, and POST.

In some embodiments, the wakeup circuit 7404 comprises an accelerometer button sensor 7405. In aspects, the transition circuit segment 7402 is configured to be energized, while the other circuit segments of the plurality of circuit segments of the segmented circuit 7401 are in a low energy state, non-energized state, or energized state. It is composed of. The accelerometer button sensor 7405 may monitor the movement or acceleration of the surgical instrument 6480 described herein. For example, the movement can be a change in orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction with respect to the three-dimensional Euclidean space, for example, by the user of the surgical instrument. When the accelerometer button sensor 7405 senses movement or acceleration, the accelerometer button sensor 7405 signals the voltage control circuit 7408 and causes the voltage control circuit 7408 to apply voltage to the processor circuit segment 7414 to provide the processor and volatile memory. To the energized state. In the embodiment, the processor and the volatile memory are energized before the voltage control circuit 7409 applies a voltage to the processor and the volatile memory. In the operating mode, the processor can initiate an energized or de-energized sequence. In various aspects, the accelerometer button sensor 7405 can also signal the processor to initiate an energized or de-energized sequence. In some embodiments, the processor initiates an energization sequence when most of the individual circuit segments are in a low energy or non-energized state. In another aspect, the processor initiates a de-energized sequence when most of the individual circuit segments are energized.

Further or / or, the accelerometer button sensor 7405 can detect external movement within a predetermined neighborhood of the surgical instrument. For example, the accelerometer button sensor 7405 can sense the user of the surgical instrument 6480 described herein moving the user's hand within a predetermined neighborhood. When the accelerometer button sensor 7405 senses this external movement, the accelerometer button sensor 7405 can send a signal to the voltage control circuit 7408 and a signal to the processor, as described above. After receiving the transmitted signal, the processor can initiate an energized or de-energized sequence to shift one or more circuit segments between the three modes. In aspects, the signal sent to the voltage control circuit 7408 is sent to verify that the processor is in operating mode. In some embodiments, the accelerometer button sensor 7405 can sense when a surgical instrument has fallen and signal the processor based on the sensed fall. For example, the signal can indicate an error in the operation of individual circuit segments. One or more sensors can detect damage or malfunction of individual affected circuit segments. Based on the detected damage or malfunction, the POST controller 7412 can perform POST on the corresponding individual circuit segment.

The energized or de-energized sequence can be defined based on the accelerometer button sensor 7405. For example, the accelerometer button sensor 7405 can sense a particular motion or sequence of motions indicating the selection of a particular circuit segment for a plurality of circuit segments. Based on the sensed motion or series of sensed motions, the accelerometer button sensor 7405 gives indications for one or more of the circuit segments when the processor is energized. The including signal can be transmitted to the processor. Based on this signal, the processor determines an energization sequence that includes one or more selected circuit segments. Further or / or, the user of the surgical instrument 6480 described herein chooses the number and order of circuit segments and uses an energization sequence or based on interaction with the surgical instrument's graphical user interface (GUI). A non-energized sequence can be defined.

In various embodiments, the accelerometer button sensor 7405 detects when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein, or external movement within a predetermined neighborhood above a predetermined threshold. Can only send a signal to the voltage control circuit 7408 and a signal to the processor. For example, a signal can only be sent if the movement is detected for more than 5 seconds, or if the surgical instrument has been moved more than 5 inches. In another aspect, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and the processor only when the accelerometer button sensor 7405 detects the vibrational movement of the surgical instrument. .. Predetermined thresholds reduce inadvertent transitions in the circuit segments of surgical instruments. As described above, the transition can include a transition to an operating mode following an energized sequence, a transition to a low energy mode following a non-energized sequence, or a transition to a sleep mode following a non-energized sequence. In some embodiments, the surgical instrument comprises an actuator that can be actuated by the user of the surgical instrument. This operation is sensed by the accelerometer button sensor 7405. The actuator may be a slider, a toggle switch, or an instantaneous contact switch. Based on the sensed operation, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and also the processor.

The boost current circuit 7406 is coupled to the battery. The boost current circuit 7406 is a current amplifier such as a relay or transistor and is configured to amplify the magnitude of the current in each circuit segment. The initial magnitude of the current corresponds to the supply voltage provided by the battery to the segmented circuit 7401. Suitable relays include solenoids. Suitable transistors include field effect transistors (FETs), MOSFETs and bipolar junction transistors (BJTs). The boost current circuit 7406 can amplify the magnitude of the current corresponding to an individual circuit segment or circuit that requires more current draw during operation of the surgical instrument 6480 described herein. For example, an increase in current with respect to the motor control circuit segment 7428 can be provided when the motor of the surgical instrument requires more input power. The increase in current provided to an individual circuit segment can cause a corresponding decrease in current in another circuit segment or multiple circuit segments. Further or / or, the increase in current may correspond to the voltage provided by an additional voltage source that works with the battery.

The voltage control circuit 7408 is coupled to the battery. The voltage control circuit 7408 is configured to provide or remove voltage from a plurality of circuit segments. The voltage control circuit 7408 is also configured to increase or decrease the voltage provided to the plurality of circuit segments of the segmented circuit 7401. In various aspects, the voltage control circuit 7408 comprises a combination logic circuit such as a multiplexer (MUX) that selects an input, a plurality of electronic switches, and a plurality of voltage converters. The electronic switch of the plurality of electronic switches may be configured to switch between an open configuration and a closed configuration to disconnect individual circuit segments from the battery or connect to the battery. The plurality of electronic switches may be solid-state devices such as transistors, or in particular other types of switches such as wireless switches, ultrasonic switches, accelerometers, inertial sensors and the like. Combination logic circuits are configured to select individual electronic switches to allow voltage application to the corresponding circuit segments by switching to an open configuration. Combination logic circuits are also configured to switch to a closed configuration and select individual electronic switches to allow the removal of voltage from the corresponding circuit segment. By selecting a plurality of individual electronic switches, the combinatorial logic circuit can implement a non-energized sequence or an energized sequence. The plurality of voltage converters can provide a boosted voltage or a bucked voltage to a plurality of circuit segments. The voltage control circuit 7408 may also include a microprocessor and a memory device.

The safety controller 7410 is configured to perform a safety check of the circuit segment. In some embodiments, the safety controller 7410 performs a safety check when one or more individual circuit segments are in operating mode. Safety checks may be performed to determine if there are any errors or defects in the function or operation of the circuit segment. The safety controller 7410 can monitor one or more parameters of a plurality of circuit segments. The safety controller 7410 can verify the identification information and operation of a plurality of circuit segments by comparing one or more parameters with the default parameters. For example, when the RF energy modality is selected, the safety controller 7410 verifies that the joint motion parameters of the shaft match the predetermined joint motion parameters of the surgical instrument 6480 described herein. The operation of the RF energy modality can be verified. In some embodiments, the safety controller 7410 may, by means of a sensor, monitor a predetermined relationship between one or more characteristics of the surgical instrument to detect a failure. Failure can occur when one or more properties do not match a given relationship. If the safety controller 7410 determines that there is a failure, an error, or the operation of some of the circuit segments has not been verified, the safety controller 7410 will fail the failure, error, or verification. Prevents or disables the operation of a particular circuit segment that occurs.

The POST controller 7412 performs POST to verify the proper operation of the plurality of circuit segments. In some embodiments, POST is an individual circuit of multiple circuit segments before the voltage control circuit 7408 applies voltage to the individual circuit segments to transition the individual circuit segments from standby or sleep mode to operating mode. Implemented for the segment. If individual circuit segments do not pass through POST, then no particular circuit segment transitions from standby or sleep mode to operating mode. The POST of the handle circuit segment 7416 may include, for example, testing whether the handle control sensor 7418 senses the operation of the handle control of the surgical instrument 6480 described herein. In some embodiments, the POST controller 7412 can signal the accelerometer button sensor 7405 to verify the operation of individual circuit segments as part of POST. For example, after receiving a signal, the accelerometer button sensor 7405 can prompt the user of the surgical instrument to move the surgical instrument to multiple different positions and check the operation of the surgical instrument. .. The accelerometer button sensor 7405 may also monitor the output of the circuit segment or the circuit of the circuit segment as part of the POST. For example, the accelerometer button sensor 7405 can sense the incremental motor pulse generated by the motor 7432 and verify its operation. The motor controller of the motor control circuit 7430 can be used to control the motor 7432 to generate incremental motor pulses.

In various aspects, the surgical instrument 6480 described herein may include an additional accelerometer button sensor. The POST controller 7412 may also execute a control program stored in the memory device of the voltage control circuit 7408. The control program can cause the POST controller 7412 to transmit signals requesting matching encryption parameters from a plurality of circuit segments. Failure to receive matching encryption parameters from individual circuit segments indicates to POST controller 7412 that the corresponding circuit segment is corrupted or malfunctioning. In some embodiments, if the POST controller 7412 determines that the processor is corrupted or malfunctioning based on POST, the POST controller 7412 signals one or more secondary processors, one. Alternatively, two or more secondary processors can be made to perform limit functions that the processor cannot perform. In some embodiments, if the POST controller 7412 determines that one or more circuit segments are not working properly based on POST, then the POST controller 7412 fails or properly POSTs. It is possible to start a low performance mode of a properly operating circuit segment while locking out a non-operating circuit segment. The locked out circuit segment can function in the same way as a circuit segment in standby mode or sleep mode.

Processor circuit segment 7414 includes a processor and volatile memory. The processor is configured to initiate an energized or de-energized sequence. To initiate an energization sequence, the processor sends an energization signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply voltage to a plurality of circuit segments or a subset of the circuit segments according to the energization sequence. To initiate a de-energized sequence, the processor sends a de-energized signal to the voltage control circuit 7408 to remove voltage from the voltage control circuit 7408 from multiple circuit segments or subsets of the circuit segments according to the de-energized sequence. Let me.

The handle circuit segment 7416 comprises a handle control sensor 7418. The handle control sensor 7418 may sense the operation of one or more handle controls of the surgical instrument 6480 described herein. In various aspects, one or more handle controls include clamp controls, release buttons, articulation switches, energy activation buttons, and / or any other suitable handle controls. The user can activate the energy activation button to select RF energy mode, ultrasonic energy mode, or a combination of RF energy mode and ultrasonic energy mode. The handle control sensor 7418 can also facilitate the attachment of modular handles to surgical instruments. For example, the handle control sensor 7418 can sense the proper attachment of the modular handle to the surgical instrument and indicate the perceived attachment to the user of the surgical instrument. The LCD display 7426 can provide a sensed mounting graphic display. In some embodiments, the steering wheel control sensor 7418 senses the activation of one or more steering wheel controls. Based on the sensed operation, the processor can initiate either an energized sequence or a non-energized sequence.

The communication circuit segment 7420 includes a communication circuit 7422. The communication circuit 7422 includes a communication interface for facilitating signal communication between individual circuit segments of a plurality of circuit segments. In some embodiments, the communication circuit 7422 provides a path for the modular components of the surgical instrument 6480 described herein for electrical communication. For example, the module shaft and module transducer can be attached integrally to the handle of a surgical instrument and the control program can be uploaded to the handle via communication circuit 7422.

The display circuit segment 7424 comprises an LCD display 7426. The LCD display 7426 may include a liquid crystal display screen, an LED indicator, and the like. In some embodiments, the LCD display 7426 is an organic light-emitting diode (OLED) screen. The display may be placed on, embedded, or remotely placed on the surgical instrument 6480 described herein. For example, the display may be placed on the handle of a surgical instrument. The display is configured to provide sensory feedback to the user. In various aspects, the LCD display 7426 further comprises a backlight. In some embodiments, the surgical instrument may also include an audible feedback device such as a speaker or buzzer and a haptic feedback device such as a tactile actuator.

The motor control circuit segment 7428 comprises a motor control circuit 7430 coupled to the motor 7432. The motor 7432 is coupled to the processor by transistors such as drivers and FETs. In various aspects, the motor control circuit 7430 includes a motor current sensor that signals and communicates with the processor to provide the processor with a signal indicating a measurement of the current draw of the motor. The processor sends a signal to the display. The display receives this signal and displays the measured value of the current draw of the motor 7432. The processor uses signals to monitor, for example, that the current draw of motor 7432 is within acceptable limits, compare the current draw with one or more parameters of multiple circuit segments, and patient. One or more parameters of the treatment site can be determined. In various aspects, the motor control circuit 7430 comprises a motor controller that controls the operation of the motor. For example, the motor control circuit 7430 controls various motor parameters, for example by adjusting the speed, torque, and acceleration of the motor 7432. This adjustment is based on the current through the motor 7432 measured by the motor current sensor.

In various aspects, the motor control circuit 7430 comprises a force sensor that measures the forces and torques generated by the motor 7432. Motor 7432 is configured to activate the mechanism of the surgical instrument 6480 described herein. For example, the motor 7432 is configured to control the operation of the shaft of a surgical instrument to provide clamping, rotation, and joint motor functions. For example, the motor 7432 can actuate the shaft to provide a clamping motion with the jaws of the surgical instrument. The motor controller can determine whether the material clamped by the jaws is tissue or metal. The motor controller may also determine how much the jaw clamps the material. For example, the motor controller can determine the degree of opening and closing of the jaws based on the sensed motor current or derivative of the motor voltage. In some embodiments, the motor 7432 is configured to actuate the transducer to apply torque to the handle or to control the joint movement of the surgical instrument. The motor current sensor can interact with the motor controller to set the motor current limit. If the current meets a predetermined threshold limit, the motor controller initiates a corresponding change in motor control operation. For example, when the motor current limit is exceeded, the motor controller reduces the current draw of the motor.

The energy treatment circuit segment 7434 includes an RF amplifier and safety circuit 7436, as well as an ultrasonic signal generator circuit 7438 to implement the energy module function of the surgical instrument 6480 described herein. In various aspects, the RF amplifier and safety circuit 7436 are configured to control the RF modality of the surgical instrument by generating an RF signal. The ultrasonic signal generator circuit 7438 is configured to control the ultrasonic energy modality by generating an ultrasonic signal. The RF amplifier and safety circuit 7436, as well as the ultrasonic signal generator circuit 7438, can jointly operate to control the combined RF and ultrasonic energy modality.

The shaft circuit segment 7440 comprises a shaft module controller 7442, a module control actuator 7444, one or more end effector sensors 7446, and a non-volatile memory 7448. The shaft module controller 7442 is configured to control a plurality of shaft modules, including a control program executed by the processor. Multiple shaft modules implement shaft modality such as ultrasound, combined ultrasound and RF, RF I-blades and RF facing jaws. The shaft module controller 7442 can select the shaft modality by selecting the corresponding shaft module executed by the processor. The module control actuator 7444 is configured to actuate the shaft according to the selected shaft modality. After activation is initiated, the shaft articulates the end effectors according to one or more parameters, routines or programs specific to the selected shaft modality and the selected end effector modality. One or more end effector sensors 7446 located on the end effector may include a force sensor, a temperature sensor, a current sensor, or a motion sensor. One or more end effector sensors 7446 transmit data about the operation of one or more end effectors based on the energy modality performed by the end effectors. In various aspects, the energy model comprises a combination of ultrasonic energy modality, RF energy modality or ultrasonic energy modality and RF energy modality. The non-volatile memory 7448 stores a shaft control program. The control program includes one or more shaft-specific parameters, routines or programs. In various embodiments, the non-volatile memory 7448 may be a ROM, EPROM, EEPROM, or flash memory. The non-volatile memory 7448 stores the shaft module corresponding to the selected shaft of the surgical instrument 6480 described herein. The shaft module may be modified or upgraded in the non-volatile memory 7448 by the shaft module controller 7442, depending on the surgical instrument shaft used during operation.

FIG. 41 is a schematic of a circuit 7925 of various components of a surgical instrument having a motor control function, according to at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein is configured to drive a shaft and / or gear component to perform various movements associated with the surgical instrument 6480. The drive mechanism 7930 may be included. In one aspect, the drive mechanism 7930 includes, for example, a rotary drive train 7932 configured to rotate the end effector about a longitudinal axis with respect to the handle housing. The drive mechanism 7930 further includes a closed drive train 7934 configured to close the jaw member and grip the tissue with an end effector. Further, the drive mechanism 7930 includes a launch drive train 7936 configured to open and close the clamp arm portion of the end effector to grip the tissue with the end effector.

The drive mechanism 7930 includes a selector gearbox assembly 7938 that can be located within the handle assembly of the surgical instrument. Proximal to the selector gearbox assembly 7938, any second motor 7944 and motor drive circuit 7946 (second motor 7944 and motor) with one of the drive trains 7932, 7934, 7936 selectively positioned. Functions to selectively move the gear element within the selector gearbox assembly 7938 to engage with the input drive component (indicated by a broken line to indicate that the drive circuit 7946 is any component). , There is a function selection module including a first motor 7942.

With reference to FIG. 41, the motors 7942 and 7944 are coupled to the motor control circuits 7946 and 7948, respectively, and the motor control circuits 7946 and 7948 include the flow of electrical energy from the power supply 7950 to the motors 7942 and 7944, respectively. It is configured to control the operation of the 7944. The power source 7950 may be a DC battery (eg, a rechargeable lead-based, nickel-based, lithium-ion-based battery, etc.) or any other power source suitable for providing electrical energy to surgical instruments.

Surgical instruments further include a microcontroller 7952 (“controller”). In certain examples, the controller 7952 may include a microprocessor 7954 (“processor”) and one or more computer-readable media or memory units 7965 (“memory”). In a particular example, memory 7965 may store various program instructions that, when executed, may cause processor 7954 to perform multiple functions and / or calculations described herein. it can. The power supply 7950 can be configured to supply power to the controller 7952, for example.

Processor 7954 may communicate with motor control circuit 7946. Further, when the memory 7965 is executed by the processor 7954 in response to the user input 7985 or the feedback element 7960, the motor control circuit 7946 stimulates the motor 7942 to generate at least one rotational motion, the selector gearbox assembly 7938. The gear element within can be selectively moved to selectively position one of the drive trains 7932, 7934, 7936 to engage the input drive component of the second motor 7944. Can store program instructions. Further, the processor 7954 may communicate with the motor control circuit 7948. The memory 7965 also causes the motor control circuit 7948 to stimulate the motor 7944 to generate at least one rotational motion when executed by the processor 7954 in response to user input 7985, eg, driving the input of a second motor 7948. It can store program instructions that can drive a drive train that is engaged with a component.

Controllers 7952 and / or other controllers of the present disclosure may be implemented using integrated and / or discrete hardware, software, and / or combinations of both. Examples of integrated hardware elements include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor elements, chips, microchips, chipsets, microcontrollers, system-on-a-chips. Chips (SoCs) and / or single in-line packages (SIPs) can be mentioned. Examples of discrete hardware components may include circuits and / or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and / or relays. In certain examples, the controller 7952 may include, for example, a hybrid circuit having discrete and integrated circuit elements or components on one or more substrates.

In certain examples, the controller 7952 and / or other controller of the present disclosure may be, for example, the LM 4F230H5QR available from Texas Instruments. In certain examples, Texas Instruments' LM4F230H5QR improves performance over 40MHz, among other readily available characteristics, up to 40MHz, 256KB single-cycle flash memory or other non-volatile memory on-chip memory. Prefetch buffer, 32KB single-cycle SRAM, internal ROM with Non-volatile Memory® software, 2KB EEPROM, 1 or more PWM modules, 1 or 2 or more QEI analogs, 12 An ARM Cortex-M4F processor core that includes one or more 12-bit ADCs with analog input channels. Other microcontrollers can be readily substituted for use with this disclosure. Therefore, this disclosure should not be limited to this context.

In various examples, one or more of the various steps described herein can be performed by a finite state machine that includes either a combination logic circuit or an ordinal logic circuit. Alternatively, any of the sequential logic circuits is coupled to at least one memory circuit. At least one memory circuit stores the current state of the finite state machine. The combination or order logic circuit is configured to provide a finite state machine for these steps. The sequential logic circuit may be synchronous or asynchronous. In other cases, one or more of the various steps described herein can be performed, for example, by a circuit that includes a combination of processor 7985 and a finite state machine.

In various cases, it may be advantageous to be able to assess the functional state of the surgical instrument to ensure proper functioning. For example, a drive mechanism configured to include various motors, drive trains and / or gear components to perform various movements of a surgical instrument, as described above, wears over time. Can be considered. This can occur through normal use, but in some cases the drive mechanism can wear faster due to overuse conditions. In certain examples, the surgical instrument can be configured to perform a self-assessment to determine the condition of the drive mechanism and its various components, eg, health.

For example, using self-diagnosis to determine if a surgical instrument is capable of performing its function prior to resterilization, or if some of its components should be replaced and / or repaired. Can be done. Evaluation of drive mechanisms and their components, including but not limited to rotary drive train 7932, closed drive train 7934, and / or launch drive train 7936, can be achieved in a variety of ways. The magnitude of the deviation from the predicted performance can be used to determine the likelihood of a detected failure and the severity of such failure. Several metrics may be used, including periodic analysis of repeatably predictable events, peaks or drops above the expected threshold and width of failure.

In various examples, one or more characteristic waveforms of a properly functioning drive mechanism or its components are used to create one or more states of the drive mechanism or its components. Can be evaluated. One or more vibration sensors may be placed with respect to one or more of the properly functioning drive mechanisms or components thereof and among the properly functioning drive mechanisms or components thereof. Various vibrations that occur during one or more operations can be recorded. The recorded vibrations can be used to generate characteristic waveforms. The state of the drive mechanism and its components can be evaluated by comparing future waveforms with characteristic waveforms.

Continuing with reference to FIG. 41, the surgical instrument 7930 was configured to record and analyze one or more of the drive trains 7932, 7934, 7936, one or more acoustic outputs. Includes drive train failure detection module 7962. Processor 7954 can communicate with module 7962 or can be controlled in other ways. As described in more detail below, module 7962 comprises a computer-readable medium (eg, memory 7965) that stores computer-readable program instructions that can be executed by a circuit, hardware, processor (eg, processor 7954). It can be embodied as various means such as computer program products, or some combinations thereof. In some embodiments, the processor 36 may include module 7962 or may be controlled in other ways.

FIG. 42 is an alternative system 132000 for controlling the frequency of the ultrasonic electromechanical system 132002 and detecting its impedance according to at least one aspect of the present disclosure. System 132000 may be incorporated into the generator. Processor 132 004 coupled to a memory 132 026 programs the programmable counter 132006, is tuned to the output frequency _{f o} of the ultrasound electromechanical systems 132,002. The input frequency is generated by the crystal oscillator 132008 and is input to the fixed counter 132010 to scale the frequency to a suitable value. The outputs of the fixed counter 132010 and the programmable counter 132006 are applied to the phase / frequency detector 132012. The output of the phase / frequency detector 132012 may be applied to the amplifier / active filter circuit 132014 generates a regulated voltage _{V t} that is applied to the voltage controlled oscillator 132016 (voltage controlled oscillator, VCO) . VCO132016 applies the output frequency _{f o} the modeled ultrasonic transducer section of the ultrasound-electromechanical systems 132,002 depicted herein as equivalent electric circuit. The voltage signal and current signal applied to the ultrasonic converter are monitored by the voltage sensor 132018 and the current sensor 132020.

The outputs of the voltage sensor 132018 and the current sensor 13020 are applied to another phase / frequency detector 132022 to determine the phase angle between the voltage and current measured by the voltage sensor 132018 and the current sensor 13020. The output of the phase / frequency detector 132022 is applied to one channel of the high speed analog-to-digital converter 132024 (ADC) and is provided to the processor 132004 via it. Optionally, to determine the phase angle between the voltage and current signals applied to the ultrasonic electromechanical system 132002, the outputs of the voltage sensor 132018 and the current sensor 132020 are applied to each channel of the two-channel ADC 132020. And may be provided to processor 132004 for zero crossover, FFT, or other algorithms described herein.

Optionally, the adjustment voltage _{V t} which is proportional to the output frequency _{f o} may be fed back to the processor 132,004 through ADC132024. This feedback signal proportional to the output frequency f _o is provided to the processor 132 004, it is possible to adjust and control the output frequency f _o using this feedback.

Temperature Estimates FIGS. 43A-43B are graph representations of complex impedance spectra of the same ultrasonic device with low temperature (room temperature) and high temperature ultrasonic blades, according to at least one aspect of the present disclosure, 133000, 133010. As used herein, a low temperature ultrasonic blade refers to a room temperature ultrasonic blade, and a high temperature ultrasonic blade refers to an ultrasonic blade after being heated by friction during use. Figure 43A is a graphical representation 133,000 impedance phase angle φ as a function of the resonance frequency f _o of the same ultrasonic device with a low and high temperature of the ultrasonic blade, FIG. 43B, the same comprises a low and high temperature ultrasonic blade magnitude of the impedance as a function of the resonance frequency _{f o} of the ultrasound system | is a graphical representation 133,010 | Z. Impedance phase angle φ and the impedance magnitude | Z | is a minimum at the resonant frequency f _o.

The ultrasonic transducer impedance Z _g (t) can be measured as the ratio of the drive signal _{generator voltage V g} (t) to the current _{Ig (t) drive signal.}

As shown in FIG. 43A, the ultrasonic blade, for example at low temperatures such as room temperature, when not being heated by friction, electromechanical resonance frequency f _o of the ultrasonic device is about 55,500Hz, ultrasound transducer The excitation frequency of is set to 55,500 Hz. Therefore, the ultrasonic transducer is excited by an electromechanical resonant frequency f _o, when the ultrasonic blade is low, the phase angle phi, is a minimum or about 0Rad as indicated by cold blade plot 133,002. As shown in FIG. 43B, the ultrasonic blade is low, when the ultrasonic transducer is excited by an electromechanical resonant frequency f _o, the magnitude of the impedance | Z | is 800 [Omega, e.g., the impedance magnitude S | Z | is the minimum impedance and the drive signal amplitude is maximum due to the series resonance equivalent circuit of the ultrasonic electromechanical system shown in FIG.

Referring now to FIG. 43A and FIG. 43B again, the ultrasonic transducer, at the generator voltage _V g (t) signal and the generator current _I g (t) signal by 55,500Hz electromechanical resonance frequency _{f o} When driven, the phase angle φ between the generator voltage V _{g (t)} signal generator current I _{g (t)} signal is zero, the magnitude of the impedance | Z | minimum impedance, for example, 800Ω Yes, the signal amplitude is peak or maximum due to the series resonance equivalent circuit of the ultrasonic electromechanical system. When the temperature of the ultrasonic blade is increased, due to the frictional heat generated during use, electromechanical resonance frequency f _o of the ultrasound system _'is reduced. Because ultrasonic transducers are still driven by the generator voltage _V g (t) signal and the generator current _I g (t) signal by the 55,500Hz previous (cold blade) electromechanical resonant frequency _{f o,} super ultrasound system operates in off resonance f _{o ',} it causes a shift in the phase angle φ between the generator voltage V _{g (t)} and the signal generator current I _{g (t)} signal. There is also an increase in the impedance magnitude | Z | of the drive signal and a decrease in the peak magnitude with respect to the (low temperature blade) electromechanical resonance frequency before 55,500 Hz. Therefore, the temperature of the ultrasonic blade is _{the phase angle φ between the generator voltage V g} (t) signal and the generator current _Ig (t) signal, and the electromechanical resonance frequency f due to the temperature change of the ultrasonic blade. It can be estimated by measuring as a change in _o.

As mentioned above, the electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade. As mentioned above, the ultrasonic converter has a first branch with capacitance and a second "working" branch with series-connected inductance, resistance, and capacitance that defines the electromechanical properties of the resonator. May be modeled as an equivalent series resonant circuit (see FIG. 25). Electromechanical ultrasonic systems have an initial electromechanical resonance frequency defined by the physical properties of the ultrasonic converter, waveguide, and ultrasonic blade. _{The ultrasonic converter is excited by an AC voltage V g} (t) and current _Ig (t) signal at an electromechanical resonance frequency, eg, a frequency equal to the resonance frequency of the electromechanical ultrasonic system. When the electromechanical ultrasonic system is excited at the resonant frequency, _{the phase angle φ between the voltage V g} (t) signal and the current _Ig (t) signal is zero.

In other words, at resonance, the similar inductive impedance of an electromechanical ultrasonic system is equal to the similar capacitive impedance of an electromechanical ultrasonic system. When the ultrasonic blade is heated, for example due to frictional engagement with tissue, compliance with the ultrasonic blade (modeled as equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system. In this embodiment, as the temperature of the ultrasonic blade rises, the resonant frequency of the electromechanical ultrasonic system decreases. Therefore, the similar inductive impedance of an electromechanical ultrasonic system is no longer equal to the similar capacitive impedance of an electromechanical ultrasonic system, thereby with the drive frequency and new resonance frequency of the electromechanical ultrasonic system. Inconsistency is caused during. Therefore, in the case of high temperature ultrasonic blades, the electromechanical ultrasonic system operates "off resonance". The mismatch between the drive frequency and the resonance frequency manifests itself as a phase angle φ between the _{voltage V g} (t) signal and the current _{Ig (t) signal applied to the ultrasonic converter.}

As described above, the generator electronic device can easily monitor the phase angle φ between the _{voltage V g} (t) signal and the current _{Ig (t) signal applied to the ultrasonic converter.} The phase angle φ is, among the above-mentioned techniques, Fourier analysis, weighted minimum square estimation, Kalman filtering, space vector-based technique, zero intersection method, lithage diagram, trivoltometer method, cross coil method, vector voltmeter and vector. It can be determined by the impedance method, phase standard equipment, and phase lock loop. The generator can continuously monitor the phase angle φ and adjust the drive frequency until the phase angle φ becomes zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. Changes in phase angle φ and / or generator drive frequency can be used as indirect or estimated measurements of ultrasonic blade temperature.

Various techniques are available to estimate the temperature from the data of these spectra. Most notably, it employs a set of time-varying nonlinear state-space equations over a range of generator drive frequencies to model the dynamic relationship between ultrasonic blade temperature and measured impedance. Can be

ここで発生器駆動周波数の範囲は装置モデルに固有である。

Here, the range of generator drive frequencies is specific to the device model.

Temperature Estimating Method One aspect of estimating or estimating the temperature of an ultrasonic blade may include three steps. First, we define a time- and energy-dependent temperature and frequency state-space model. To model temperature as a function of frequency components, a set of nonlinear state-space equations is used to model the relationship between electromechanical resonance frequency and ultrasonic blade temperature. Second, a Kalman filter is applied to improve the accuracy of the temperature estimator and state space model over time. Third, a state estimator is provided in the feedback loop of the Kalman filter to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to regulate the temperature of the ultrasonic blade. The three steps are described below.

Process 1
The first step is to define a time- and energy-dependent temperature and frequency state-space model. To model temperature as a function of frequency components, a set of nonlinear state-space equations is used to model the relationship between electromechanical resonance frequency and ultrasonic blade temperature. In one aspect, the state space model is given by the following equation.

The state-space model is the intrinsic frequency of the _{electromechanical ultrasonic system with respect to the intrinsic frequencies F n} (t), temperature T (t), energy E (t), and time t.

の変化率及び超音波ブレードの温度

Rate of change and ultrasonic blade temperature

の変化率を表す。

Represents the rate of change of.

は、電気機械的超音波システムの固有周波数数Ｆ_ｎ（ｔ）、超音波ブレードの温度Ｔ（ｔ）、超音波ブレードに印加されるエネルギーＥ（ｔ）、及び時間ｔなどの測定可能かつ観察可能な変数の可観測性を表す。超音波ブレードの温度Ｔ（ｔ）は、推定値として観察可能である。

Is measurable and observable such as the intrinsic frequency number F _n (t) of the electromechanical ultrasonic system, the temperature T (t) of the ultrasonic blade, the energy E (t) applied to the ultrasonic blade, and the time t. Represents the observability of possible variables. The temperature T (t) of the ultrasonic blade can be observed as an estimated value.

Step 2
The second step is to apply a Kalman filter to improve the temperature estimator and state space model. FIG. 44 is a diagram of a Kalman filter 133020 for improving the temperature estimator and state space model based on impedance according to the equation.

これは、本開示の少なくとも１つの態様による、様々な周波数で測定された超音波変換器にわたるインピーダンスを表す。

This represents the impedance across the ultrasonic transducers measured at various frequencies according to at least one aspect of the present disclosure.

The Kalman filter 133020 may be used to improve temperature estimation performance, allowing the enhancement of external sensors, models, or prior information to improve temperature prediction in noisy data. The Kalman filter 133020 includes a regulator 133022 and a plant 133024. In control theory, plant 133024 is a combination of process and actuator. Plant 133024 can be referred to as a transfer function that indicates the relationship between the input and output signals of the system. The regulator 133022 includes a state estimator 133026 and a controller K133028. The state regulator 133026 includes a feedback loop 133030. The state regulator 133026 receives the output y of the plant 133024 and the feedback variable u as inputs. The state estimator 133026 is an internal feedback system that converges on the true value of the state of the system. The output of the state estimator 133026 is

であり、完全なフィードバック制御変数は、電気機械的超音波システムのＦ_ｎ（ｔ）、超音波ブレードの温度の推定値Ｔ（ｔ）、超音波ブレードに印加されるエネルギーＥ（ｔ）、位相角φ、及び時間ｔを含む。コントローラＫ１３３０２８への入力は

The complete feedback control variables are F _n (t) of the electromechanical ultrasonic system, the estimated value T (t) of the temperature of the ultrasonic blade, the energy E (t) applied to the ultrasonic blade, and the phase. Includes angle φ and time t. Input to controller K133028

であり、コントローラＫ１３３０２８の出力ｕは、状態推定器１３３０２６及びプラント１３３０２４のｔにフィードバックされる。

The output u of the controller K133028 is fed back to the state estimator 133026 and the plant 133024 t.

Kalman filtering, also known as linear quadratic estimation (LQE), uses a set of measurements observed over time, including statistical noise and other inaccuracies, and a coupling probability distribution across variables in a single time frame. Is an algorithm that generates an estimate of an unknown variable that tends to be more accurate than one based on a single measurement alone, by estimating and thus calculating the maximum likelihood estimate of the actual measurement. .. The algorithm works in a two-step process. In the prediction process, the Kalman filter 133020 produces an estimate of the current state variable, along with their uncertainties. When the results of the next measurement are observed (which inevitably breaks with some amount of error, including random noise), these estimates are updated using a weighted average for higher certainty estimates. Higher weight is given. The algorithm is recursive and can be run in real time using only the current input measurements as well as the previously calculated state and its uncertainty matrix, no additional historical information is required.

The Kalman filter 133020 provides a dynamic model of an electromechanical ultrasonic system, known control inputs to the system, and the intrinsic frequency and phase angle of the signal applied to the ultrasonic converter (eg, the electrical impedance of the ultrasonic converter). Multiple continuous measurements (observations) of (magnitude and phase) of) are used to form an estimate (its state) of the changing amount of the electromechanical ultrasound system and the ultrasound of the electromechanical ultrasound system. Predict the temperature of the blade portion, which is better than the estimate obtained using only one measurement. Therefore, the Kalman filter 133020 is an algorithm that includes a sensor and data fusion to provide a maximum likelihood estimate of the temperature of the ultrasonic blade.

The Kalman filter 133020 effectively handles the uncertainty due to the noisy measurements of the signal applied to the ultrasonic converter to measure the intrinsic frequency and phase shift data, and also the uncertainty due to random external factors. Handle certainty effectively. The Kalman filter 133020 produces an estimate of the state of the electromechanical ultrasonic system as the average of the predicted state of the system using the weighted average and the new measurements. Weighted values provide better (ie, smaller) estimated uncertainty and are more "reliable" than unweighted values. The weight can be calculated from the covariance, which is a measure of the estimated uncertainty of the prediction of system state. The weighted average result is a new state estimate located between the predicted and measured states, which has better estimation uncertainty than either alone. This process is repeated in all time steps, and the new estimates and their covariances provide the predictions used in the following iterations. This recursive property of the Kalman filter 133020 requires only the final "best guess" to calculate the new state, rather than the entire history of the state of the electromechanical ultrasonic system.

The relative certainty of the measurements and current state estimates is an important consideration, and it is common to discuss the filter response to the gain K of the Kalman filter 133020. Kalman gain K is a relative weight given to the measured value and the current state estimate and can be "tuned" to achieve a particular performance. For high gain K, the Kalman filter 133020 places more weight on the latest measurement and therefore follows the latest measurement more responsively. For low gain K, the Kalman filter 133020 follows the model prediction more closely. At extremes, a high gain close to 1 results in a more variable estimated trajectory, and a low gain close to zero removes noise but reduces responsiveness.

When performing the actual calculations of the Kalman filter 133020 (as described below), the state estimates and covariances are encoded in a matrix to handle multiple dimensions involved in a single set of calculations. This allows the representation of linear relationships between various state variables (position, velocity, acceleration, etc.) in either the transition model or the covariance. The use of the Kalman filter 133020 does not assume that the error is Gauss. However, the Kalman filter 133020 provides accurate conditional probability estimates in special cases where all errors are Gaussian.

Process 3
The third step uses the state estimator 133026 in the feedback loop 133032 of the Kalman filter 133020 to control the power applied to the ultrasonic transducer and thus the ultrasonic blade. To do.

FIG. 45 is a graphical representation of the three probability distributions adopted by the state estimator 133026 of the Kalman filter 133020 shown in FIG. 44 to maximize the estimated value according to at least one aspect of the present disclosure. The probability distributions include the pre-probability distribution 133042, the predicted (state) probability distribution 133044, and the observed probability distribution 133046. The three probability distributions 133042, 133544, 1330467 are applied to the ultrasonic transducers to regulate the temperature based on the impedance across the ultrasonic converters measured at various frequencies according to at least one aspect of the present disclosure. Used for power feedback control. The estimator used for feedback control of the power applied to the ultrasonic transducer to regulate the temperature based on impedance is given by the following equation:

これは、本開示の少なくとも１つの態様による、様々な周波数で測定された超音波変換器にわたるインピーダンスである。

This is the impedance across the ultrasonic transducers measured at various frequencies according to at least one aspect of the present disclosure.

The pre-probability distribution 133042 includes the state variation defined by the following equation.

State fluctuation

は、予測（状態）確率分布１３３０４４として表されるシステムの次の状態を予測するために使用される。観測確率分布１３３０４６は、観測分散σ_ｍが以下の式によって与えられるゲインを定義するために用いられる、システム状態の実際の観測値の確率分布である。

Is used to predict the next state of the system, represented as the predicted (state) probability distribution 133044. The observed probability distribution 133046 is the probability distribution of the actual observed values of the system state used to define the gain given by the _{observed variance σ m by the following equation.}

Feedback Control The power input is reduced to ensure that the temperature (estimated by the state estimator and Kalman filter) is controlled.

In one aspect, the early proof of concept assumed a static linear relationship between the intrinsic frequency of the electromechanical ultrasonic system and the temperature of the ultrasonic blade. By reducing the power as a function of the intrinsic frequency of the electromechanical ultrasonic system (ie, adjusting the temperature by feedback control), the temperature of the ultrasonic blade tip can be directly controlled. In this embodiment, the temperature of the distal tip of the ultrasonic blade can be controlled so that it does not exceed the melting point of the Teflon pad.

FIG. 46A is a graph display of temperature vs. time of the ultrasonic device without temperature feedback control 133050. The temperature (° C.) of the ultrasonic blade is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The test was performed using chamois leather placed inside the jaws of the ultrasonic device. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade was excited at a resonant frequency during frictional engagement with the chamois leather clamped between the ultrasonic blade and the clamp arm. Over time, the temperature (° C.) of the ultrasonic blade rises due to frictional engagement with chamois leather. Over time, the temperature profile 133052 of the ultrasonic blade rises at a temperature of 220 ° C. after about 19.5 seconds, as shown at point 133504, until the chamois sample is cut. Without temperature feedback control, after the chamois leather sample is cut, the temperature of the ultrasonic blade rises well above the melting point of TEFLON, about 380 ° C, up to a temperature of about 490 ° C. At point 133506, the temperature of the ultrasonic blade reaches a maximum temperature of 490 ° C. until the TEFLON pad is completely melted. The temperature of the ultrasonic blade drops slightly from the peak temperature at point 133506 after the pad has completely disappeared.

FIG. 46B is a temperature vs. time plot of an ultrasonic device with temperature feedback control according to at least one aspect of the present disclosure. The temperature (° C.) of the ultrasonic blade is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The test was performed using a chamois leather sample placed in the jaws of the ultrasonic device. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade was excited at a resonant frequency during frictional engagement with the chamois leather clamped between the ultrasonic blade and the clamp arm pad. Over time, the temperature profile 133662 of the ultrasonic blade rises until the chamois sample is cut at a temperature of 220 ° C. after about 23 seconds, as shown at point 133064. With temperature feedback control, the temperature of the ultrasonic blade rises to a maximum temperature of about 380 ° C, just below the TEFLON melting point, shown at point 133066, and then generally drops to an average of about 330 ° C, shown in region 133068. This prevents the TEFLON pad from melting.

Application of smart ultrasonic blade technology When the ultrasonic blade is immersed in a fluid-filled surgical field, the ultrasonic blade is cooled during startup, reducing its effectiveness in sealing and cutting tissue in contact with it. Be done. Cooling the ultrasonic blades can result in longer start-up times and / or hemostasis problems because sufficient heat is not delivered to the tissue. More energy delivery may be required to reduce transverse incision time and achieve suitable hemostasis under these fluid immersion conditions to overcome the cooling of the ultrasonic blades. Using a frequency-temperature feedback control system, the ultrasonic blade temperature is either below a certain temperature at the start or remains below a certain temperature for a certain period of time. If detected, the output power of the generator can be increased to offset cooling by blood / saline / other fluids present in the surgical field.

Therefore, the frequency-temperature feedback control system described herein is of an ultrasonic device, especially when the ultrasonic blade is partially or wholly located or immersed in a fluid-filled surgical field. Performance can be improved. The frequency-temperature feedback control system described herein minimizes potential problems with long start-up times and / or ultrasonic device performance in fluid-filled surgical fields.

As mentioned above, the temperature of the ultrasonic blade is to detect the impedance of the ultrasonic transducer given by the following equation.

あるいは同等に、超音波変換器に印加される電圧Ｖ_ｇ（ｔ）信号と電流Ｉ_ｇ（ｔ）信号との間の位相角φを検出することによって推定することができる。位相角φの情報はまた、超音波ブレードの状態を推定するために使用されてもよい。本明細書で詳細に論じられるように、位相角φは、超音波ブレードの温度の関数として変化する。したがって、位相角φ情報は、超音波ブレードの温度を制御するために用いられてもよい。これは、例えば、超音波ブレードが過度に高温で動作しているときは超音波ブレードに送達される電力を低減し、超音波ブレードが過度に低温で動作しているときは超音波ブレードに送達される電力を増加させることによって行われ得る。図４７Ａ〜図４７Ｂは、超音波ブレードの急激な温度低下が検出されたときに超音波変換器に印加される超音波電力を調節するための温度フィードバック制御のグラフ表示である。

Alternatively equally, it can be estimated by detecting the phase angle φ between the voltage V _{g (t)} signal and the current I _{g (t)} signal applied to the ultrasonic transducer. The information on the phase angle φ may also be used to estimate the state of the ultrasonic blade. As discussed in detail herein, the phase angle φ changes as a function of the temperature of the ultrasonic blade. Therefore, the phase angle φ information may be used to control the temperature of the ultrasonic blade. This, for example, reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at an excessively high temperature, and delivers it to the ultrasonic blade when the ultrasonic blade is operating at an excessively low temperature. It can be done by increasing the power generated. 47A to 47B are graph displays of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic converter when a sudden temperature drop of the ultrasonic blade is detected.

FIG. 47A is a graphical representation of the ultrasonic power output 133070 as a function of time according to at least one aspect of the present disclosure. The power output of the ultrasonic generator is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. FIG. 47B is a graphical representation of the ultrasonic blade temperature 133080 as a function of time, according to at least one aspect of the present disclosure. The ultrasonic blade temperature is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The temperature of the ultrasonic blade is increased by applying a constant power of 133072, as shown in FIG. 47A. During use, the temperature of the ultrasonic blade drops sharply. This can be due to a variety of conditions, but during use, the temperature of the ultrasonic blade when immersed in a fluid-filled surgical field (eg, blood, saline, water, etc.) Can be presumed to decrease. At time t _0, the temperature of the ultrasonic blade, drops below a desired minimum temperature 133,082, Frequency - temperature feedback control algorithm detects a drop in temperature, power increase delivered to the ultrasonic blade (power 'ramp) The power rise or "ramp up" indicated by 133074 is initiated to start raising the temperature of the ultrasonic blade above the desired minimum temperature of 133082.

With reference to FIGS. 47A and 47B, the ultrasonic generator outputs a substantially constant power of 133072 as long as the temperature of the ultrasonic blade remains above the desired minimum temperature of 133082. At t ₀ , when the generator and / or instrument processor and / or control circuit detects that the temperature of the ultrasonic blade drops below the desired minimum temperature of 133072, it initiates a frequency-temperature feedback control algorithm to superimpose. The temperature of the ultrasonic blade is raised above the lowest desired temperature 133082. Therefore, the power of the generator begins to increase at _{t 1} corresponding to the detection of a sudden drop in the temperature of the ultrasonic blade at _{t 0 (133704).} Under the frequency-temperature feedback control algorithm, the power continues to increase until the temperature of the ultrasonic blade exceeds the desired minimum temperature of 133082 (133074).

FIG. 48 is a logical flow of a process showing a control program or logical configuration for controlling the temperature of an ultrasonic blade according to at least one aspect of the present disclosure. According to this process, the processor and / or control circuit of the generator or instrument performs one aspect of the frequency-temperature feedback control algorithm described in connection with FIGS. 47A and 47B to the ultrasonic transducer. A power level is applied to (133092) to achieve the desired temperature in the ultrasonic blade. Generator, monitors the phase angle φ between the voltage _V g (t) signal and the current _I g (t) signal is applied to drive the ultrasonic transducer (133,094). Based on the phase angle φ, the generator estimates the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 43A-45 (133906). The generator determines whether the temperature of the ultrasonic blade is below the desired minimum temperature by comparing the estimated temperature of the ultrasonic blade with a predetermined desired temperature (133098). The generator then adjusts the power level applied to the ultrasonic transducer based on the comparison. For example, when the temperature of the ultrasonic blade is above the desired minimum temperature, the process proceeds along the "no" branch, and when the temperature of the ultrasonic blade is below the desired minimum temperature, along the "yes" branch. Proceed. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator to the ultrasonic transducer, for example, by increasing _{the voltage V g} (t) signal and / or the current _{Ig (t) signal.} The power level is increased (133100) to raise the temperature of the ultrasonic blade and continue to increase the power level applied to the ultrasonic converter until the temperature of the ultrasonic blade rises above the lowest desired temperature.

Adaptive Advanced Tissue Treatment Pad Saver Mode FIG. 49 is a graph representation of ultrasonic blade temperature 133110 as a function of time during vascular firing, according to at least one aspect of the present disclosure. The ultrasonic blade temperature plot 133112 is graphed along the vertical axis as a function of time along the horizontal axis. The frequency-temperature feedback control algorithm combines the temperature of the ultrasonic blade feedback control with the jaw sensing capability. The frequency-temperature feedback control algorithm provides optimal hemostasis balanced with the durability of the device and can intelligently deliver energy for best encapsulation while protecting the clamp arm pad.

As shown in FIG. 49, the optimum temperature 133114 for vascular encapsulation _{is marked as the first} target temperature T1 and the optimum temperature 133116 for the "infinite" clamp arm pad life is the second target temperature. Marked as T _2. Frequency - temperature feedback control algorithm estimates the temperature of the ultrasonic blade, maintaining the temperature of the ultrasonic blade between the first target temperature thresholds T ₁ and second target temperature threshold value T _2. Therefore, the generator power output is driven to achieve the optimum ultrasonic blade temperature for sealing the vessel and extending the life of the clamp arm pad.

First, when the blade heats up and the temperature of the ultrasonic blade rises, and finally _{exceeds the first target temperature threshold T 1} , the temperature of the ultrasonic blade rises. The frequency-temperature feedback control algorithm takes over and controls the blade temperature to T _{1 until the transvascular incision is completed at t 0} (133118) and the ultrasonic blade temperature _{falls below the second target temperature threshold T 2} . The processor and / or control circuit of the generator and instrument detects when the ultrasonic blade comes into contact with the clamp arm pad. When the cross-vascular incision is _{completed and detected at t 0} , the frequency-temperature feedback control algorithm controls the temperature of the ultrasonic blade to the second target threshold T ₂ to extend the life of the clam arm pad. Switch to. The optimum clamp arm pad life temperature for the TEFLON clamp arm pad is about 325 ° C. In one aspect, advanced tissue treatment may be announced to the user with a second activation tone.

FIG. 50 is a logical flow of a process showing a control program or logical configuration for controlling the temperature of an ultrasonic blade between two temperature settings shown in FIG. 49 according to at least one aspect of the present disclosure. .. According to this process, the generator performs one aspect of the frequency-temperature feedback control algorithm, eg, the voltage V _g (t) signal and / or the current _Ig (t) applied to the ultrasonic transducer. adjust the signal, by setting the ultrasonic blade temperature to a first target T ₁ that is optimized to vessel sealing, applying a first power level to the ultrasonic transducer (133,122). As described above, the generator, monitors the phase angle φ between the voltage V _{g (t)} signal and the current I _{g (t)} signal applied to the ultrasonic transducer (133,124), the phase angle φ Based on this, the transducer estimates the temperature of the ultrasonic blade using the techniques described herein in relation to FIGS. 43A-45 (133126). Frequency - As the temperature feedback control algorithm, processor or control circuitry or both of generator or instrument, until transection is completed, maintaining the ultrasonic blade temperature to a first target temperature T _1. Frequency-temperature feedback control algorithms may be used to detect the completion of the transvascular incision process. The processor and / or control circuit of the generator and instrument determines when the transvascular incision is complete (133128). This process follows a "no" branch when the transvascular incision is not complete and a "yes" branch when the transvascular incision is complete.

If the transverse vascular incision is not complete, the processor and / or control circuit of the generator or instrument is set to _{a temperature T 1 optimized for vascular encapsulation and transverse incision by the ultrasonic blade temperature.} It is determined whether or not (133130). When the ultrasonic blade temperature is _{set to T 1} , the process proceeds along the "yes" branch and the generator or instrument processor and / or control circuit is applied to the ultrasonic transducer and the phase angle φ based on, to continue monitoring the phase angle phi (133,124) between the voltage _V g (t) signal and the current _I g (t) signal. If ultrasonic blade temperature is not set to T _1, the process proceeds along the "No" branch, processor or control circuitry or both of generator or instrument continues, the first ultrasonic transducer A power level is applied (133122).

Once the transvascular incision is complete, the processor or control circuit of the generator or instrument applies a second power level to the ultrasonic transducer (133132) to extend the life of the ultrasonic blade and clamp arm pad. setting a second target temperature T ₂ which is optimized in order to maintain or prolong. The processor and / or control circuit of the generator and instrument _{determines if the temperature of the ultrasonic blade is the set temperature T 2} (133134). If the ultrasonic blade temperature is set to T2, the process completes the transvascular incision procedure (133136).

Blade Start Temperature By knowing the ultrasonic blade temperature at the start of the transverse incision, the generator delivers the appropriate amount of power to heat the blade for rapid cutting, or the blade is already hot. If so, it may be possible to add as much power as is needed. This technique can achieve a more consistent transverse incision time and extend the life of the clam arm pad (eg, TEFLON clamp arm pad). Knowing the temperature of the ultrasonic blade at the start of the transverse incision may allow the generator to deliver the correct amount of power to the ultrasonic converter, resulting in the desired amount of displacement of the ultrasonic blade.

FIG. 51 is a logical flow of a process showing a control program or logical configuration for determining the initial temperature of an ultrasonic blade according to at least one aspect of the present disclosure. In order to determine the initial temperature of the ultrasonic blade, the resonance frequency of the ultrasonic blade is measured at room temperature or a predetermined ambient temperature in the manufacturing plant. Baseline frequency values are recorded and stored in the generator and / or instrument lookup table. The baseline value is used to generate the transfer function. At the beginning of the ultrasonic converter start-up cycle, the generator measures the resonant frequency of the ultrasonic blade (133142), compares the measured resonant frequency with the baseline resonant frequency value (133144), and the frequency difference (Δf). ) Is determined. Δf is compared to a corrected ultrasonic blade temperature look-up table or transfer function. The resonance frequency of the ultrasonic blade can be determined by sweeping the frequencies of the _{voltage V g} (t) signal and the current _{Ig (t) signal applied to the ultrasonic converter.} The resonance frequency is a frequency at which the phase angle φ voltage V _g (t) signal and the current _Ig (t) signal are zero, as described herein.

Once the resonant frequency of the ultrasonic blade is determined, the generator or instrument processor and / or control circuit determines the initial temperature of the ultrasonic blade based on the difference between the measured resonant frequency and the baseline resonant frequency. Is determined (133146). The generator, for example, _{adjusts the voltage V g} (t) drive signal and / or current _Ig (t) drive signal to one of the following values before activating the ultrasonic transducer. Sets the power level delivered to the ultrasonic transducer.

The processor and / or control circuit of the generator and instrument determines if the initial temperature of the ultrasonic blade is low (133148). If the initial temperature of the ultrasonic blades is low, the process proceeds along a "yes" branch, and the processor or control circuit of the generator or instrument, or both, applies high power levels to the ultrasonic transducer (133152). , Raise the temperature of the ultrasonic blade to complete the transvascular incision procedure (133156).

If the initial temperature of the ultrasonic blade is not low, the process proceeds along a "no" branch and the processor and / or control circuit of the generator or instrument determines if the initial temperature of the ultrasonic blade is high. (133150). If the initial temperature of the ultrasonic blades is high, the process proceeds along a "yes" branch, and the processor or control circuit of the generator or instrument, or both, applies a low power level to the ultrasonic transducer (133154). , Lower the temperature of the ultrasonic blade and complete the transvascular incision procedure (133156). If the initial temperature of the ultrasonic blade is not high, the process proceeds along a "no" branch and the processor and / or control circuit of the generator or instrument completes the transvascular incision (133156).

Smart blade technology for controlling blade instability The temperature of the ultrasonic blade and the contents in the jaws of the ultrasonic end effector can be determined using the frequency-temperature feedback control algorithm described herein. it can. The frequency / temperature relationship of the ultrasonic blade is used to control the instability of the ultrasonic blade by temperature.

As described herein, there is a well-known relationship between frequency and temperature in ultrasonic blades. Some ultrasonic blades exhibit displacement instability or mode instability in the presence of temperature rise. This known relationship is used to interpret when the ultrasonic blade is approaching instability and then adjust the power level to drive the ultrasonic converter (eg, the drive voltage applied to the ultrasonic converter). By adjusting the V _g (t) signal and / or the current _Ig (t) signal), the temperature of the ultrasonic blade can be modulated to prevent the instability of the ultrasonic blade.

FIG. 52 determines when the ultrasonic blade is approaching instability according to at least one aspect of the present disclosure, followed by powering the ultrasonic converter to prevent instability. FIG. 133 is a logical flow of a process showing a control program or logical configuration to adjust. Frequency / temperature relationship of the ultrasonic blade exhibiting instability displacement or mode, sweeping the driving voltage V _{g (t)} signal or current I _{g (t)} signals or frequency of both over the temperature of the ultrasonic blade, the result Is mapped by recording. Functions or relationships that can be used / interpreted by the control algorithms performed by the generator are generated. Trigger points can be established using this relationship to notify the generator that the ultrasonic blade is approaching known blade instability. Generator, so that the driving power level is reduced (e.g., by reducing the drive voltage V _{g (t)} or current I _{g (t)} or both which is applied to the ultrasonic transducer), frequency - The temperature feedback control algorithm processing function and closed-loop response are performed to modulate the temperature of the ultrasonic blade below the trigger point to prevent a given blade from reaching instability.

The advantage is the simplification of the ultrasonic blade configuration so that the instability characteristics of the ultrasonic blade need not be excluded from the design and can be compensated for by using the instability control technique of the present invention. Be done. The instability control technique of the present invention can further enable new ultrasonic blade shapes and improve the stress profile of heated ultrasonic blades. In addition, the ultrasonic blades may be configured to reduce the performance of the ultrasonic blades when used with generators that do not use this technique.

According to the process illustrated by logic flow diagram 133 160, a processor or controller, or both of the generator or instrument, voltage V _{g (t)} which is applied to the ultrasonic transducer signal and the current I _{g (t)} signal and Monitor the phase angle φ between (133162). The processor and / or control circuit of the generator and instrument is ultrasonic _{based on the phase angle φ between the voltage V g} (t) signal and the current _Ig (t) signal applied to the ultrasonic transducer. Estimate the temperature of the blade (133164). The generator and / or instrument processor and / or control circuit compares the estimated temperature of the ultrasonic blade with the ultrasonic blade instability trigger point threshold (133166). The processor and / or control circuit of the generator and instrument determines if the ultrasonic blade is approaching instability (133168). If not, the process proceeds along the "no" branch, monitoring the phase angle φ (133162), estimating the temperature of the ultrasonic blade (133164), and the ultrasonic blade until the ultrasonic blade approaches instability. The estimated temperature of the ultrasonic blade is compared with the instability trigger point threshold of the ultrasonic blade (133166). The process then proceeds along the "yes" branch, where the generator or instrument processor and / or control circuit adjusts the power level applied to the ultrasonic transducer (133170), and the temperature of the ultrasonic blades. Modulate.

Ultrasonic Sealing Algorithms with Temperature Control Ultrasonic sealing algorithms for ultrasonic blade temperature control use the frequency-temperature feedback control algorithms described herein to improve hemostatic properties of the ultrasonic blades. It can be adopted to utilize the frequency / temperature relationship.

In one aspect, as described in the various aspects of the present disclosure, a frequency-temperature feedback control algorithm is employed to provide ultrasound based on the measured resonant frequency (using spectroscopy) associated with temperature. The power level applied to the converter can be changed. In one aspect, the frequency-temperature feedback control algorithm may be triggered by an energy button on the ultrasonic instrument.

Optimal tissue effect is to increase the power level to drive the ultrasonic transducer to the initial sealing cycle (e.g., the drive voltage V _g applied to the ultrasonic transducer _(t) or current I _{g (t)} or both by increasing) the tissue is dried rapidly heated, then reduce the power level to drive the ultrasonic transducer (e.g., applied to the ultrasonic transducer drive voltage V _g ( It is known that it can be obtained by gradually forming the final seal (by reducing t) and / or current _{Ig (t).} In one aspect, the frequency-temperature feedback control algorithm according to the present disclosure sets a limit on the temperature threshold that the tissue can reach as the tissue heats up during the high power level stage, followed by a clamp jawpad (eg, eg). The temperature of the ultrasonic blade is controlled by lowering the power level based on the melting point of TEFLON) to complete the sealing. The control algorithm can be implemented by activating an energy button on the instrument for a more responsive / adaptive encapsulation to reduce the complexity of the hemostatic algorithm.

FIG. 53 is a logical flow of a process showing a control program or logical configuration for providing ultrasonic encapsulation with temperature control according to at least one aspect of the present disclosure. According to the control algorithm, the processor and / or control circuit of the generator or instrument activates the sensing of the ultrasonic blade using spectroscopy (eg, smart blade) (133182) and the resonant frequency of the ultrasonic blade (eg, eg, smart blade). The resonance frequency of the ultrasonic electromechanical system) is measured (133184) and the temperature of the ultrasonic blade is determined using the frequency-temperature feedback control algorithm (spectroscopy) described herein. As mentioned above, the resonant frequency of the ultrasonic electromechanical system is mapped to obtain the temperature of the ultrasonic blade as a function of the resonant frequency of the electromechanical ultrasonic system.

First desired resonant frequency f _x of the ultrasound electromechanical system corresponds to a first desired temperature Z ° of the ultrasonic blade. In one aspect, the first desired ultrasonic blade temperature Z ° is the optimum temperature for tissue coagulation (eg, 450 ° C). The second desired frequency f _Y of the ultrasonic electromechanical system corresponds to the second desired temperature ZZ ° of the ultrasonic blade. In one aspect, the second desired ultrasonic blade temperature ZZ ° is a temperature of 330 ° C., which is lower than the melting point of the clamp arm pad, which is about 380 ° C. in the case of TEFLON.

Processor or control circuitry or both of generator or instrument compares the measured resonance frequency of the ultrasonic electromechanical system with a first desired frequency f _x (133186). In other words, the process determines if the temperature of the ultrasonic blade is lower than the temperature for optimal tissue coagulation. If the measured resonant frequency of the ultrasonic electromechanical system is lower than the first desired frequency f _x, the process is "NO", the flow proceeds along the branch, processor or control circuitry or both of generator or instrument , measured resonance frequency of the ultrasonic electromechanical system to greater than a first desired frequency f _x, to raise the temperature increased to (133,188) ultrasonic blade power level applied to the ultrasonic transducer .. In this case, tissue coagulation process is complete, the process controls the temperature of the ultrasonic blade, the second desired temperature corresponding to a second desired frequency f _y.

The process proceeds along a "yes" branch, where the generator or instrument processor and / or control circuit reduces the power level applied to the ultrasonic transducer (133190), reducing the temperature of the ultrasonic blades. Let me. The processor or control circuit of the generator and / or instrument measures the resonant frequency of the ultrasonic electromechanical system (133192) and compares the measured resonant frequency with a second desired frequency f _Y. If the measured resonance frequency is _{greater than or equal to the second desired frequency f Y} , then the processor and / or control circuit of the generator or instrument will have the measured resonance frequency less than _{or equal to the second desired frequency f Y.} Reduces the ultrasonic output level to (133190). Frequency - temperature feedback control algorithm maintains the measured resonance frequency of the ultrasonic electromechanical system to a second below the desired frequency f _y (e.g., temperature of the ultrasonic blade is less than the temperature of the clamp arm pad melting point There is), then the generator performs an increase in the level of power applied to the ultrasonic converter to increase the temperature of the ultrasonic blade until the tissue transverse incision process is complete (133196).

FIG. 54 is a graph representation of ultrasonic transducer current and ultrasonic blade temperature as a function of time, according to at least one aspect of the present disclosure. FIG. 54 shows the results of application of the frequency-temperature feedback control algorithm described in FIG. 53. Graph 133200 shows a first plot 133 202 of the ultrasonic blade temperature as ultrasound transducer current time function for the second plot 133 204 of _I g (t) as a function of time. As shown, the transducer _Ig (t) is kept constant until the ultrasonic blade temperature reaches the optimum solidification temperature of 450 ° C. _{When the ultrasonic blade temperature reaches 450 ° C, the frequency-temperature feedback control algorithm uses, for example, the converter current Ig} (until the temperature of the ultrasonic blade drops below 330 ° C, which is below the melting point of the TEFLON pad, for example. t) is reduced.

Identification or Parameterization of Tissue Types In various embodiments, surgical instruments (eg, ultrasonic surgical instruments) identify or parameterize the tissue gripped by the end effector, and the various movements of the surgical instrument accordingly. It is configured to adjust the parameters. Tissue identification or parameterization can include the type of tissue (eg, physiological tissue type), the physical properties or attributes of the tissue, the tissue composition, the position of the tissue within or relative to the end effector, and the like. In one example discussed in more detail below, the ultrasonic surgical instrument will adjust the displacement amplitude of the distal tip of the ultrasonic blade according to the collagen / elastin ratio of the tissue detected in the jaws of the end effector. It is configured. As mentioned above, the ultrasonic instrument comprises an ultrasonic converter acoustically coupled to the ultrasonic blade via an ultrasonic waveguide. The displacement of the ultrasonic blade is a function of the power applied to the ultrasonic converter, so the power delivered to the ultrasonic converter can be modulated according to the detected collagen / elastin ratio of the tissue. In another example, discussed in more detail below, the force exerted by the clamp arm on the tissue can be modulated according to the position of the tissue with respect to the end effector. Various techniques for identifying or parameterizing tissues are described herein and further details are described, for example, in "SMART ENERGY DEVICES", the disclosure of which is incorporated herein by reference in its entirety. It can be found in US Patent Provisional Application No. 62 / 692,768, entitled June 30, 2018.

Determining Tissue Position Through Impedance Changes With reference back to FIG. 23, an end effector 1122 with an ultrasonic blade 1128 and a clamp arm 1140 according to at least one aspect of the present disclosure is shown. FIG. 55 is a bottom view of the ultrasonic end effector 1122 showing the clamp arm 1140 and the ultrasonic blade 1128 according to at least one aspect of the present disclosure and depicting the positioning of tissue within the ultrasonic end effector 1122. Tissue positioning between the clamp arm 1140 and the ultrasonic blade 1128 is described in the distal region 130420 and the proximal region 130422. Etc., can be delineated according to the area or area in which the tissue is located.

Here, with reference to FIGS. 23 and 55, the ultrasonic end effector 1122 grips the tissue between the ultrasonic blade 1128 and the clamp arm 1140, as described herein. Once the tissue is gripped, an ultrasonic generator (eg, the generator 1100 described in connection with FIG. 22) is acoustically coupled to the ultrasonic blade 1128 via an ultrasonic waveguide. It can be activated to apply power to the ultrasonic converter. The power applied to the ultrasonic transducer can be in the therapeutic or non-therapeutic range of energy levels. With applied power in the non-therapeutic range, the resulting displacement of the ultrasonic blade 1128 does not affect, or only minimizes, the gripped tissue so as not to coagulate or cut the tissue. Non-therapeutic excitation can be particularly useful in determining the impedance of an ultrasonic converter, which, among other conditions, eg, tissue type, tissue location within the end effector, different tissue type. It varies based on various conditions present in the end effector 1122, including the ratio of and the temperature of the ultrasonic blade. Various of these conditions are described herein. The impedance of the ultrasonic transducer is as described herein.

によって与えられる。超音波エンドエフェクタ１１２２での状態が、非治療的超音波エネルギーレベルを使用して決定されると、特定の外科処置に関連付けられた他の変数の中でも、組織治療、効果的なシール、横切開、及び期間を最適化するために、決定されたエンドエフェクタ１１２２の状態に基づいて治療的超音波エネルギーが印加され得る。治療エネルギーは、組織を凝固及び切断するのに十分である。

Given by. When the condition at the ultrasound end effector 1122 is determined using non-therapeutic ultrasound energy levels, tissue treatment, effective sealing, transverse incision, among other variables associated with a particular surgical procedure. , And to optimize the duration, therapeutic ultrasonic energy may be applied based on the determined end effector 1122 condition. Therapeutic energy is sufficient to coagulate and cleave the tissue.

In one aspect, the present disclosure relates to the thickness of tissue located within the jaws of the ultrasonic end effector 1122 (ie, between the clamp arm 1140 and the ultrasonic blade 1128), as shown in FIGS. 23 and 55. It provides a control process such as an algorithm for determining the type. Further details regarding the detection of various states and properties of an object gripped by the end effector 1122 can be found in the section "DETERMINING JAW STATE" below and with "SMART ENERGY DEVICES". It is discussed in the title US Patent Provisional Application No. 62 / 692,768.

FIG. 56 is a graph showing the change in ultrasonic converter impedance as a function of tissue position within the ultrasonic end effector 1122 over the range in which a given ultrasonic generator power level increases, according to at least one aspect of the present disclosure. The display is 130000. The horizontal axis 130004 represents the position of the tissue, and the vertical axis 130002 represents the transducer impedance (Ω). Various limits along the horizontal axis 130004, such as the first or proximal limit 130010 and the second or distal limit 130012, depict different locations of tissue gripped within the ultrasonic end effector 1122, or It can correspond to them. Depictions of proximal and distal tissue locations are schematically shown in FIG. 55 (ie, proximal portion 130422 and distal portion 130420). The plots 130006 and 130008 show the transducer impedance Ω when the power applied to the ultrasonic converter changes from the minimum or first non-therapeutic power level L ₁ to the maximum or second non-therapeutic power level L _2. Represents change. The greater the change in transducer impedance Ω, the closer the resulting plot is to the distal limit 130012. Therefore, the position of the tissue corresponds to the position of the plot obtained for various limits (eg, proximal limit 130010 and distal limit 130012). In the first plot 130006, δ1 represents the change in transducer impedance when the tissue is located in the proximal portion 130422 of the end effector 1122. This can be seen from the fact that the first plot 130006 does not exceed the proximal limit 130010. In the second plot 130008, δ2 represents the change in transducer impedance when the tissue is located at the distal end 130012 of the end effector 1122. This can be seen from the fact that the first plot 130006 exceeds the proximal limit 130010 and / or is located near the distal limit 130012. As shown by plots 130006, 130008, δ ₂ is much larger than _{δ 1.}

Measured obtained when power (voltage and current) is applied to the ultrasonic converter to operate the ultrasonic blade 1128 in a non-treatment range (eg, power not sufficient to cut or coagulate tissue). The converter impedance (Ω) is a useful indicator of the position of the tissue within the jaws of the end effector 1122, whether at the distal end 130420 or the proximal end 130422 of the ultrasonic blade 1128 as shown in FIG. Is. The location of the tissue within the end effector 1122 is the transducer impedance as the non-therapeutic power level applied to the ultrasonic converter changes from the minimum power level (eg L ₁ ) to the maximum power level (eg L ₂ ). It can be determined based on the change in δ. In some embodiments, the non-therapeutic power level (s) applied to the ultrasonic converter make the ultrasonic blade 1128 less than the sensing amplitude or the minimum therapeutic amplitude (eg, the distal end of the ultrasonic blade 1128 and). / Or can be vibrated at 35 μm or less at the proximal end). Impedance calculations have been discussed earlier in this disclosure. When the first power level L ₁ is applied, a measurement of the first converter impedance Z ₁ is taken, which provides the initial measurement and the applied power is up to the second power level L _2. Subsequent measurements of impedance Z ₂ are taken again when increased. In one aspect, it is _{twice the first power level L 1} = 0.2A and the second power level L ₂ = 0.4A or the first power level L ₁ , while the voltage is kept constant. .. The obtained longitudinal displacement amplitude of the ultrasonic blade 1128, based on the applied power level, provides an indicator of the position of the tissue within the jaws of the end effector 1122. In one exemplary implementation, the first power level L ₁ produces a longitudinal displacement amplitude of 35 μm at the distal end 130420 and 15 μm at the proximal end 130422. Further, in this example, the second power level _{L 2,} the longitudinal amplitude of 70μm at the distal end 130,420, and generates a 35μm in proximal end 130,422. The algorithm calculates the difference in converter impedance δ between the first and second measurements to find the impedance change ΔZ _{g (t).} Changes in impedance δ are plotted against tissue position, with higher changes in impedance representing tissue positions distributed at the distal end 130012 and lower changes in impedance representing the proximal end 130010 of the end effector 1122. It is shown that it represents the position of the tissue distributed in. In short, when the power level there is a large change in impedance with increasing from L ₁ to L _2, the tissue is positioned only distally within end effector 1122. Conversely, if there is only a slight change in impedance as the power level _{increases from L 1} to L ₂ , the tissue is more dispersed within the end effector 1122.

FIG. 57 is a graph representation of the change in ultrasonic converter impedance as a function of time with respect to the position of tissue within the ultrasonic end effector according to at least one aspect of the present disclosure. The horizontal axis 130054 represents time (t) and the vertical axis 130052 represents the change in transducer impedance (δ) between the first and second measurements. Plots 130060 and 130066 show changes in transducer impedance (δ) vs. time (t) with respect to proximal and distal positions of tissue within the bite of clamp arm 1140. With respect to the positions of the proximal and distal tissues, the force of the clamp arm 1140 is applied to hold the tissue within the ultrasonic end effector 1122 and a delay period is applied before the first low power level is applied. , The converter impedance is measured. The system then applies a second higher power level and measures the impedance again. It should be understood that both the first and second power levels applied to the ultrasonic transducer are non-therapeutic power levels. The algorithm executed by the processor or control circuit portion of the generator or surgical instrument (eg, processor 902 in FIG. 21 or control circuit 760 in FIG. 18) is a first power level at the location of proximal and distal tissues. Calculate the difference in converter impedance (δ) between and the second power level. If the difference in transducer impedance (δ) is below the first threshold of 130056, as shown in connection with the first plot 130060, the algorithm determines that the tissue is located within the proximal portion 130422 of the end effector 1122. Then it is determined. In the first plot 130060, the difference in transducer impedance between the measurements increases 130062 over time until it plateaus 130064 below the first threshold 130056 or maintains it. As shown in connection with the first plot 130066, if the difference in transducer impedance (δ) exceeds the second threshold 130058, the algorithm determines that the tissue is located within the distal portion 130420 of the end effector 1122. Then it is determined. In the second plot 130066, the difference in transducer impedance between the measurements increases 130068 over time until it plateaus or maintains 130070 above the second threshold 130058. If the difference in converter impedance (δ) is between the first and second thresholds 130056, 130058, the algorithm says that the tissue is within the central portion 130424 of the end effector 1122, eg, the proximal portion and the distal portion of the end effector. It is determined that it is located between the parts.

FIG. 58 shows the logic of process 130100, showing a control program or logic configuration for identifying operation in the non-therapeutic range of power applied to the instrument to determine tissue positioning, according to at least one aspect of the present disclosure. It is a flow chart. Process 130100 can be performed by a processor or control circuit of a surgical instrument such as the control circuit 760 of FIG. 18 or a generator such as the processor 902 of FIG. For brevity, process 130100 is described as being performed by a processor, but it should be understood that the following description embraces the aforementioned variants.

According to one aspect of process 130100, the processor closes the clamp arm 1140 and the clamp arm 1140 and the ultrasonic blade 1128. A control signal is applied to capture the tissue between and. After the clamp arm 1140 closes on the tissue, the processor waits for a predetermined delay period to allow the tissue to soften and some water to be abandoned. After the delay period, the processor sets the power level applied to the ultrasonic transducer to the first non-therapeutic power level (130102). Optionally, one aspect of process 130100 includes the ability to use feedback control to verify that the first power is set below the therapeutic power level. In this aspect, the processor determines if the first power level is below the therapeutic power level (130106). If the first power level is greater than or equal to the therapeutic power level, process 130100 proceeds along the "no" branch, the processor reduces the applied power (130108), and the first power level is the therapeutic power. Continue the loop until it is below the level. Process 130100 then continues along the "yes" branch, where the processor measures the first impedance Z _g1 (t) of the ultrasonic transducer corresponding to the first power level (130110). The processor then sets the power level applied to the ultrasonic converter to a second non-therapeutic power level (130112), where the second power is higher than the first power level and below the therapeutic power level. Again, feedback control can be optionally used to verify that the second power level is not only higher than the first power level, but also below the therapeutic power level. In this aspect, the processor determines if the second power level is below the therapeutic power level (130114). If the second power is greater than the therapeutic power level, process 130100 proceeds along the "no" branch and the processor reduces the second power level (130108), which falls below the therapeutic power level threshold. Continue the loop until. Process 130100 then continues along the "yes" branch, where the processor measures the second impedance _Zg2 (t) of the ultrasonic transducer corresponding to the second power level (130116). The impedance of the ultrasonic transducer can be measured using the various techniques discussed herein. The processor then calculates the difference in transducer impedance between the applied first and second power levels (130118).
δ = Z _g2 (t) −Z _g1 (t).

The processor then provides the user with an indicator of the location of the organization (130120). The processor may be a surgical instrument output device (eg, a visual feedback device such as the display shown in FIG. 31, a voice feedback device, and / or a tactile feedback device), a display 135 (FIG. 3), or a surgical instrument and /. Or tissue via another output device (eg, visual feedback device, audio feedback device, and / or tactile feedback device) of the surgical hub 106 communicatively connected to the output device 2140 (FIG. 27B) of the generator 1100. Can indicate the position of.

The processor compares the difference in converter impedance with the first and second thresholds, where, as shown in FIG. 57, if the difference in converter impedance (δ) is less than the first threshold 130056, the algorithm If the algorithm determines that the tissue is located within the proximal portion 130422 of the end effector 1122 and the difference in converter impedance (δ) exceeds the second threshold 130058, the algorithm determines that the tissue is within the distal portion 130420 of the end effector 1122. Judged to be located in. If the difference in converter impedance (δ) is between the first and second thresholds 130056, 130058, the algorithm says that the tissue is within the central portion 130424 of the end effector 1122, eg, the proximal portion of the end effector 1122 and It is determined that it is located between the distal portions 130422 and 130420. According to the process described, the impedance of the ultrasonic transducer is used to distinguish what percentage of the tissue is located distal, proximal, or intermediate to the end effector 1122, and then the preferred therapeutic power. Levels can be applied.

Switchless Mode Based on Tissue Positioning In various embodiments, the response of the ultrasound instrument is whether the tissue is present within the end effector, the type of tissue located within the end effector, or the tissue located within the end effector. It can be based on compressibility or composition. Therefore, the generator or ultrasonic surgical instrument to implement an algorithm that controls the time between clamping the tissue in the jaw of the end effector and activating the ultrasonic converter to treat the tissue. Orders may be accommodated and / or executed. If tissue is not detected, the ultrasonic generator activation button or pedal may be assigned different meanings to perform different functions. In one aspect, advanced energy devices may use detection of the presence of tissue in the end effector jaws as a queue to activate the ultrasonic transducer, thereby initiating a tissue coagulation cycle. In another aspect, compression properties and situational awareness allow automatic startup of the device and can also adjust the parameters of the algorithm for the type of tissue sensed. For example, advanced generators may ignore button or foot pedal activation unless tissue is perceived by contact with the end effector jaws. This configuration eliminates inadvertent activation queues that allow the device to operate in a simpler manner.

Thus, advanced generators such as the advanced generators described in connection with FIGS. 1-42 and / or surgical instruments such as ultrasonic surgical instruments described throughout the disclosure are in switchless mode. It may be configured to work with. In switchless mode, the ultrasonic device is automatically activated in coagulation mode when it senses or detects the presence of tissue in the end effector jaws. In one aspect, when operating in automatic energy activation (or "switchless" mode) mode, the control algorithm that controls the activation of the ultrasonic surgical instrument is activated when not operating in switchless mode. It can be configured so that less energy is initially applied to the ultrasonic instrument than in the case. In addition, the ultrasonic generator or instrument can be configured to determine both contact with tissue located within the jaws of the end effector and the type of tissue. Based on sensing or detecting the presence of tissue in the end effector jaws, a control algorithm executed by either the generator or the ultrasonic instrument processor or control circuit causes the ultrasonic instrument to run in switchless mode. The algorithm can be adjusted to achieve the best total coagulation of the tissue within the end effector jaws. In other embodiments, instead of automatically activating the surgical instrument and / or generator, a control algorithm performed by the processor or control circuit of the generator or ultrasonic instrument detects the presence of tissue within the end effector. Unless otherwise, activation of the generator or ultrasonic instrument can be prevented.

In one aspect, the disclosure is performed by a processor or control circuit located in either a generator or a handheld ultrasonic instrument to determine the presence and type of tissue located within the jaws of the end effector. Provides an algorithm. In one aspect, the control algorithm is via the techniques described herein for locating tissue, as described below in the section "Positioning Tissue Through Electrode Conduction". Can be configured to determine that the tissue is located within the end effector. For example, a control algorithm determines if tissue is within an end effector according to whether there is any conduction between the electrodes (as described below) and, accordingly, automatically upon detection of tissue. To activate the surgical instrument (eg, by initiating the application of power to the surgical instrument to the generator to which the surgical instrument is attached) or to allow the surgical instrument to be activated. Can be done. When the surgical instrument and / or generator is operating in switchless mode, the control algorithm can be further configured to activate the surgical instrument at a particular power level, which is the surgical instrument. It may or may not differ from the standard initial start-up power level. In some embodiments, the control algorithm can be detected, for example, via the technique described below in the section "Determining the Collagen to Elastin Ratio of Tissue in response to IR Surface Reflectance and Emissivity". It can be configured to activate or allow the activation of surgical instruments according to a particular type or composition of tissue. For example, a control algorithm can be configured to activate a surgical instrument when a tissue with a high collagen composition is grasped, but activate a surgical instrument when a tissue with a high elastin composition is grasped. Not always let. In some embodiments, the control algorithm is such that the grasped tissue is in a specific position within the end effector, for example, through the techniques described below in the section "Positioning the tissue through electrode conduction". It can be configured to activate or allow activation of the surgical instrument depending on whether it is located in or whether a particular amount of tissue is gripped by the end effector. For example, a control algorithm can be configured to activate a surgical instrument when the grasped tissue covers a particular percentage of end effectors. As another example, the control algorithm can be configured to activate the surgical instrument when the grasped tissue is located at the distal end of the end effector.

In another aspect, the control algorithm is described in US Patent Provisional Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. Whether the tissue is gripped by an end effector, the type or composition of the tissue, and the type or composition of the tissue, as is, and as described in the "SITUATIONAL AWARENESS" section, through a situational awareness system. It can be configured to determine the end effector or other properties of the tissue. In these embodiments, the surgical hub 106 (FIGS. 1 to 11) to which the surgical instrument and / or generator is connected is the surgical instrument, generator, and / or other medical treatment utilized in the operating room. Data can be received from the device to infer about the surgical procedure being performed or its particular steps. Therefore, the situational awareness system can estimate which type (s) of tissue is being operated on at any given moment or process, and the control algorithm then moves the surgical instrument accordingly. It can be controlled and includes the automatic activation of surgical instruments as appropriate. For example, the control algorithm causes the tissue gripped by the end effector to automatically activate or allow the activation of surgical instruments when it corresponds to the tissue type or tissue composition expected by the situation recognition system. Can be configured.

By having the ability to detect whether the instrument is in contact with tissue and what type of tissue it is when in contact, the ultrasonic instrument can operate in a switchless mode of operation. Movement is allowed based on the sensing ability of the ultrasonic instrument. In some embodiments, the control algorithm is an activation button, foot pedal, and foot pedal coupled to the generator and / or ultrasonic surgical instrument unless the tissue is sensed in contact with the jaw / end effector of the surgical instrument. It can be configured to ignore the activation of other input devices, thereby preventing unintended activation of the instrument. In some embodiments, the control algorithm is an activation button, coupled to the generator and / or ultrasonic surgical instrument, depending on whether the tissue is sensed in contact with the jaw / end effector of the surgical instrument. It can be configured to assign different meanings to the inputs of the foot pedal and other input devices. For example, when tissue is present in the end effector, the control algorithm can be configured to activate the surgical instrument in response to an activated activation button, however, when tissue is not present in the end effector. , The control algorithm can be configured to perform any different or secondary action when the activation button is activated.

The ability to determine the lack of tissue present within the end effector jaws is acceptable, allowing the instrument to change to switchless mode and then initiate an automatic coagulation cycle operation when tissue is detected. It plays a key role, leading to the use of longer uptime of the appliance and allowing the user to continue based on its predictive ability. In addition to detecting the presence of tissue, the ability to further detect tissue type allows the algorithm to regulate and calculate the best coagulation opportunities.

Adjusting the Ultrasound System According to Tissue Composition In various embodiments, the ultrasonic surgical instrument detects the composition of the tissue gripped by or gripped by the end effector and accordingly the ultrasound converter and / or A processor or control circuit that executes an adaptive ultrasonic blade control algorithm for controlling the operating parameters of the ultrasonic blade can be included. The tissue composition can include, for example, the ratio of collagen to elastin in the tissue, the hardness of the tissue, or the thickness of the tissue. Operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm can include, for example, the amplitude of the ultrasonic blade, the temperature or heat flux of the ultrasonic blade, and the like. The adaptive ultrasonic blade control algorithm can be executed by a control circuit or processor located in either the generator or the surgical instrument.

In one example described in more detail below, the adaptive ultrasonic blade control algorithm can be configured to control the amplitude of the ultrasonic blade according to the collagen-to-elastin ratio of the tissue. The collagen-to-elastin ratio of tissue can be determined through a variety of techniques, such as those described below. In another embodiment described in more detail below, the adaptive ultrasonic blade control algorithm controls the ultrasonic converter / ultrasonic blade to provide a longer heating time and terminate the ultrasonic blade. The lower the temperature, the lower the collagen content of the tissue.

Determining the Tissue Collagen to Elastin Ratio According to Frequency Shift In various embodiments, the control algorithm determines the tissue collagen to elastin ratio by detecting the intrinsic frequency of the ultrasonic blade and the shift in the ultrasonic blade waveform (eg,). , Adjusting the amplitude of the distal tip of the ultrasonic blade). For example, the techniques described in connection with FIGS. 1-54 may be used to detect the collagen-to-elastin ratio of tissue located within the end effector of an ultrasound instrument. In one aspect, the present disclosure provides an adaptive ultrasonic blade control algorithm for detecting natural frequency and waveform shifts of an ultrasonic blade to detect tissue composition in contact with the ultrasonic blade. In another aspect, the adaptive ultrasonic blade control algorithm detects the collagen and elastin composition content of the tissue and adjusts the therapeutic heat flux of the ultrasonic blade based on the detected collagen content of the tissue. It may be configured in. Techniques for monitoring the deviation of the intrinsic frequency of the ultrasonic blade based on the type of tissue located within the jaws of the end effector of the ultrasonic instrument are described herein in connection with FIGS. 1-54. There is. Therefore, for the sake of brevity and clarity of disclosure, such techniques will not be repeated here.

The ratio of elastin to collagen can be determined by monitoring the shift of the intrinsic frequency of the ultrasonic blade and comparing the intrinsic frequency with a look-up table. The look-up table can be stored in memory (eg, memory 3326 in FIG. 31) and includes the ratio of elastin to collagen, as well as the intrinsic frequency shift corresponding to a particular ratio determined empirically.

Determining the Collagen to Elastin Ratio of Tissue According to IR Surface Reflectance and Emissivity In various embodiments, the control algorithm adjusts the amplitude of the distal tip of the ultrasonic blade by determining the IR reflectance of the tissue (eg, adjusting the amplitude of the distal tip of the ultrasonic blade). It can be configured to determine the collagen-to-elastin ratio of the tissue. For example, FIG. 59 shows an ultrasonic system 130164 with an ultrasonic generator 130152 coupled to an ultrasonic instrument 130150. The ultrasonic instrument 130150 is a ultrasonic waveguide 130154. It is coupled to the ultrasonic end effector 130400 via. The ultrasonic generator 130152 may be integrated with the ultrasonic instrument 130150 or may be connected to the ultrasonic instrument 130150 using wired or wireless electrical / electronic coupling technology. The end effector 130400 of the ultrasonic surgical instrument 130150 comprises an IR sensor located on a clamp arm 130402 (eg, jaw member) according to at least one aspect of the present disclosure. The ultrasonic generator 130152 and / or the ultrasonic instrument 130150 is coupled to the surgical hub 130160 and / or the cloud 130162 via a wireless or wired connection, as described in connection with FIGS. 1-11. May be good.

FIG. 60 is an IR reflectance detection sensor circuit 130409 that can be integrally attached to or integrally formed with the clamp arm 130402 of the ultrasonic end effector 130400 to detect tissue composition according to at least one aspect of the present disclosure. Is shown. The IR sensor circuit 130409 includes an IR source 130416 (eg, an IR transmitter) and an IR detector 130418 (eg, an IR receiver). The IR source 130416 is coupled to the voltage source V. The current is generated via R2 when the control circuit 130420 closes the switch SW1. When the switch SW1 is closed, the IR source 130416 radiates IR energy towards tissue 130410 (eg, tissue clamped or placed between the clamp arm 130402 and the ultrasonic blade 130404). Part of the radiated IR energy is absorbed by tissue 130410, part of the radiated IR energy is transmitted through tissue 130410, and part of the radiated IR energy is reflected by tissue 130410. IR detectors 130,418 receives the IR energy reflected by the tissue 130 410, produces an output voltage _{V o} or a signal applied to the control circuit 130,420 for processing.

Referring to FIGS. 59 and 60, in one embodiment, the ultrasonic generator 130152 controls to drive the IR source 130416 and the IR detector 130418 located on or within the clamp arm 130402 of the ultrasonic end effector 130400. Includes circuit 130420. In another aspect, the ultrasonic instrument 130150 includes a control circuit 130420 for driving an IR source 130416 and an IR detector 130418 located on or within the clamp arm 130402 of the ultrasonic end effector 130400. In either embodiment, when the tissue 130410 is gripped between the ultrasonic blade 130404 and the clamp arm 130402, the IR source 130416 is energized by, for example, closing the switch SW1 by the control circuit 130420 to IR the tissue. Irradiate with energy. In one embodiment, IR detectors 130,418 produces a voltage _{V o} proportional to the IR energy reflected by the tissue 130,410. The total IR energy radiated by the IR source 130416 is equal to the sum of the IR energy reflected by the tissue 130410, the IR energy absorbed by the tissue 130410, the IR energy passing through the tissue 130410, and any loss. Thus, the control circuit 130420 or processor may be configured to detect the collagen content of tissue 130410 by the amount of IR energy detected by the IR detector 130418 relative to the total amount of IR energy radiated by the IR source 130416. The algorithm determines the collagen content of tissue 130410, taking into account the amount of energy absorbed by and / or transmitted through tissue 130410. The IR source 130416 and IR detector 130418 and the algorithm are calibrated using the principle of IR reflectance to provide useful measurements of the collagen content of tissue 130410.

The IR reflectance detection sensor circuit 130409 shown in FIG. 60 provides IR surface reflectance and emissivity for determining the ratio of elastin to collagen. IR reflectance can be used to determine the tissue composition for adjusting the amplitude of the ultrasonic transducer. The refractive index is an optical constant that controls the light-related reflection of IR light. The index of refraction can be used to distinguish between tissue types. For example, refractive index contrast has been shown to distinguish between normal liver tissue and liver metastases. The refractive index can be used as an absolute or comparative measure of tissue differentiation.

The comparison method uses an energy incision device, such as, for example, an ultrasonic blade 130404, to determine the exact ratio (as detailed above), and then uses that index as a baseline, all. Predict the collagen ratio for further operation of. In this way, the endoscope may update the incision device (eg, ultrasonic blade 130404) based on the collagen ratio. The incision device can be fine-tuned each time it is activated to perform the actual collagen denatured firing. An alternative method may employ an absolute index of refraction with a look-up table, which can distinguish between surface irregularities and subsurface collagen concentrations. Further information on IR refractive index properties of the tissue, "Visible To Near-Infrared Refractive Properties OF Freshly-Excised Human-Liver Tissues: Marking Hepatic Malignancies, Panagiotis Giannios, Konstantinos G.Toutouzas, Maria Matiatou, Konstantinos Stasinos, Manousos M. It can be found in Konstadoulakis, George C. Zografos, and Konstatinos Moutzourisa, Sci. Rep. 2016, 6: 27910, which is incorporated herein by reference.

In another aspect, the ultrasonic incision device can be configured to change the ideal temperature of the ultrasonic blade control algorithm in proportion to the collagen ratio. For example, the ultrasonic blade temperature control algorithm can be modified based on the collagen ratio received from control circuit 130420. As one particular example, the ultrasonic blade temperature control algorithm lowers the set of temperatures at which the ultrasonic blade 130404 is maintained, causing the ultrasonic blade 130404 to structure against higher concentrations of collagen in the grasped tissue 130410. It can be configured to increase the retention time in contact with 130410. As another example, the waiting time for the algorithm to repeat full activation can be changed based on the collagen ratio. Various temperature control algorithms for ultrasonic blades are described in connection with FIGS. 43-54.

FIG. 61 is a cross-sectional view of an ultrasonic end effector 130400 including a clamp arm 130402 and an ultrasonic blade 130404 according to one aspect of the present disclosure. The clamp arm 130402 comprises IR reflectance detection sensor circuits 130409a, 130409b that can be integrally attached to or integrally formed with the clamp arm 130402 of the ultrasonic end effector 130400 to detect the composition of the tissue 130410. The IR reflectance detection sensor circuits 130409a and 130409b may be mounted on the flexible circuit board 130412 shown in plan view in FIG. 62. The flexible circuit board 130412 includes three elongated elements 130408a, 130408b, 130408c to which the IR reflectance detection sensor circuits 130409a, 130409b and IR sensors 130414a, 130414b are attached. The IR sensors 130414a and 130414b may include an IR source 130416 and an IR detector 130418 as shown in FIG.

FIG. 63 is a logical flow diagram of process 130200 showing a control program or logical configuration for measuring IR reflectance to determine tissue composition and adjusting amplitude of an ultrasonic converter. Process 130200 can be performed by a processor or control circuit of a surgical instrument such as the control circuit 760 of FIG. 18 or a generator such as the processor 902 of FIG. For brevity, process 130200 is described as being performed by a control circuit, but it should be understood that the following description embraces the aforementioned variants.

Therefore, with reference to FIGS. 1-54 and 59-63, in one aspect, the control circuit energized the IR source 130416 (130202) and was clamped into the end effector 13400 of the ultrasonic instrument 130150. IR energy is applied to the tissue 130410. The control circuit then detects the IR energy reflected by the tissue 130410 via the IR detector 130418 (130204). Therefore, the control circuit determines the ratio of collagen to elastin in tissue 130410 based on the detected IR energy reflected by tissue 130410 (130206). The control circuit regulates the ultrasonic blade temperature control algorithm as discussed in U.S. Patent Application No. 62 / 692,768, entitled "SMART ENERGY DEVICES," based on the determined collagen-to-elastin ratio of the tissue. (130208). In one aspect, the collagen content of tissue 130410 can be detected according to the reflectance of IR light source 130416. In another aspect, the lower the collagen content of tissue 130410, the longer the heating time and the lower the end temperature of the ultrasonic blade 130404. In yet another aspect, the composition of tissue 130410 may be tissue thickness or hardness and can be used to influence the ultrasonic blade transducer control program.

The ratio of elastin to collagen can be determined by monitoring the IR reflectance of the tissue and comparing the detected IR reflectance with a look-up table. The look-up table can be stored in memory (eg, memory 3326 in FIG. 31) and contains the ratio of elastin to collagen and the IR reflectance corresponding to a particular ratio empirically determined.

Determining the Collagen to Elastin Ratio of Tissues According to Collagen Transformation Points Different types of tissues are composed of various amounts of structural proteins such as collagen and elastin that provide different types of tissues with different properties. When heat is applied to the tissue (eg, by ultrasonic blades), structural proteins are denatured, affecting tissue integrity and other tissue properties. However, structural proteins denature at different known temperatures. For example, collagen denatures before elastin. Therefore, the tissue composition (eg, the ratio of collagen to elastin in the tissue) can be estimated by detecting at what temperature the tissue properties change. In various aspects, the control algorithm can be configured to determine the collagen-to-elastin ratio of tissue by determining the collagen metamorphosis point of the tissue. The control algorithm can then control various operating parameters of the surgical instrument, such as the amplitude of the ultrasonic blade, according to the determined tissue composition. In one aspect, the control algorithm can determine the collagen transformation point of the tissue by measuring the position of the clamp arm actuating member and the rate of change in its displacement while keeping the load on the clamp arm constant. In another aspect, the control algorithm can determine the collagen transformation point of the tissue by directly measuring the temperature of the tissue / blade interface to determine the collagen / elastin ratio.

16 to 19 schematically show an electric clamp arm closing mechanism. FIG. 40 is a system diagram 7400 of a segmented circuit 7401 with a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 according to one aspect of the present disclosure, FIG. 35. Is a circuit diagram of various components of a surgical instrument having a motor control function according to one aspect of the present disclosure. For example, FIG. 35 shows a drive mechanism 7930 including a closed drive train 7934 configured to close the jaw member and grip the tissue with an end effector. 38-39 show a control system 12950-12970 for controlling the closure rate of a jaw member such as a clamp arm portion of an ultrasonic end effector, where FIG. 38 shows a clamp arm according to one aspect of the present disclosure. FIG. 39 is a diagram of a control system 12950 configured to provide gradual closure of closing members when a closing force load is applied at a desired rate by advancing distally to close. A proportional integral differential (PID) controller feedback control system 12970 according to one aspect of the present disclosure is shown. Therefore, in the following description of an ultrasonic system including an electric clamp arm controller for controlling the closing rate and / or position of the clamp arm, FIGS. 16-19 and 38-41 should be referred to.

In one aspect, the control algorithm detects the collagen transformation point of the grasped tissue and thereby controls the phase and / or amplitude of the ultrasonic converter drive signal, or the closure rate of the clamp arm. It can be configured to control the delivery of ultrasonic energy to. For example, in one aspect, the control algorithm can be configured to control the force applied to the tissue by the clamp arm according to the collagen transformation point. This allows the position of the clamp arm actuating member and its rate of change while maintaining a constant load on the clamp arm within a set operating range (eg 130-180 psi) corresponding to a particular instrument type. It can be achieved by measuring.

FIG. 64A is a graphical representation of displacement vs. time of clamp arm 1140 (FIG. 23) 130250, according to at least one aspect of the present disclosure, when clamp arm 1140 is closed to identify a collagen transformation point. FIG. 64B is an enlarged portion 130256 of the graph display 130250 shown in FIG. 64A. The horizontal axis 130254 represents time (eg, seconds) and the vertical axis 130252 represents clamp arm displacement δ (eg mm). In one aspect, the control algorithm is tissued by the clamp arm 1140 (eg, by controlling the closure rate of the clamp arm 1140) as the ultrasonic blade 1128 (FIG. 23) heats the tissue according to the collagen transformation point of the tissue. It can be configured to control the load applied to. In such an aspect, the control algorithm can be configured to close the clamp arm 1140 until the clamp arm load reaches a threshold, which is a specific value (eg, 4.5 lbs) or range of values (eg, 4.5 lbs). For example, it can include (within the range of 3.5 to 5 lbs). At that point, the control algorithm sets the rate of change threshold θ for the clamp arm displacement and clamp arm 1140. Monitor the displacement of. As long as the rate of change of the clamp arm displacement remains within a predetermined negative limit (ie, less than the threshold θ), the control algorithm can determine that the tissue is below the transformation temperature. As shown in the graphs of FIGS. 64A and 64B, if the control algorithm determines that the rate of change of the clamp arm displacement exceeds the threshold θ, the control algorithm can determine that the collagen melting temperature has been reached. ..

In one aspect, if the control algorithm determines that the transition temperature has been reached, the control algorithm can be configured to change the behavior of the ultrasonic instrument accordingly. For example, the control algorithm can switch the surgical instrument from load control (of clamp arm 1140) to temperature control. In another aspect, the control algorithm can maintain load control of the clamp arm after reaching the collagen transformation temperature and monitor when the rate of change threshold for clamp arm displacement is reached. The rate of change threshold for the second clamp arm displacement can correspond, for example, to the transition temperature of elastin. The location of collagen and / or elastin transition temperature in plot 130258 of clamp arm displacement over time can be referred to as "knee" in plot 130258. Thus, in this embodiment, the control algorithm reaches the rate of change threshold (or elastin "knee") of the second clamp rate displacement and changes the operation of the ultrasonic device accordingly. Can be configured to change. For example, the control algorithm can switch the surgical instrument from load control (of clamp arm 1140) to temperature control when the elastin knee in plot 130258 is detected.

Collagen transformation should be constant for a given heat flux between 45 ° C and 50 ° C for collagen, and elastin has different melting temperatures. In addition, the temperature should be flattened as the collagen absorbs heat. In some embodiments, the control algorithm is near a particular temperature or in a temperature range (eg, the expected temperature range of collagen and / or elastin transformation) to ascertain exactly when the monitored event occurs. ) Can be configured to sample the position of the clamp arm and / or the clamp arm displacement member at a higher rate.

In the embodiment shown in FIGS. 64A and FIG. 64B, the control algorithm, when the collagen transformation point is detected at time t _m, act to change the surgical instrument to the temperature control from the load control. Without changing the surgical instrument to temperature control, the clamp arm displacement would increase geometrically, as shown in projection plot 130260. In one aspect, the control algorithm operating in temperature control mode is by the ultrasonic blade 1128, as shown by the flat portion of plot 130258 after reducing the amplitude of the ultrasonic converter drive signal and reaching the threshold θ. Change the heat flux generated. In some embodiments, the control algorithm is to increase the amplitude of the ultrasonic transducer drive signal after a specific period, for example, to measure the rate of temperature rise and determine when the elastin transformation temperature is reached. Can be configured. Therefore, as the clamp arm closure rate approaches the next knee (ie, the elastin knee), the clamp arm closure rate can decrease. Load control of the clamp arm 1140 can be beneficial as it can, in some cases, provide the best sealing of blood vessels.

FIG. 65 shows the logical flow of process 130300 showing a control program or logical configuration for detecting the collagen transformation point and controlling the clamp arm closure rate or the amplitude of the ultrasonic converter according to at least one aspect of the present disclosure. It is a figure. Process 130300 can be performed by a control circuit or processor located within the surgical instrument or generator. Therefore, the control circuit that executes the process 130300 measures the position of the clamp arm actuating member and its rate of change while keeping the load on the clamp constant (130302). As mentioned above, in one aspect, the load on the clamp arm is maintained within a suitable range (130-180 psi) set by the ultrasonic surgical instrument. When the jaw reaches a certain clamp arm load (eg 4.5 lbs) or the clamp arm load is within a certain range (eg 3.5-5 lbs), the control circuit will change the rate of change of the clamp arm displacement. And monitor the position of the clamp arm actuating member while the rate of change of the clamp arm displacement remains within the predefined negative limits (corresponding to the tissue being below the collagen transformation temperature) (130304). Therefore, the control determines whether the rate of change of the clamp arm displacement exceeds the set threshold, in other words, whether the tissue has reached the transition temperature (130306). When the transition temperature is reached, process 130300 proceeds along the "yes" branch and the control circuit switches the surgical instrument to temperature control (130308) (eg, controlling the ultrasonic transducer to control the ultrasonic blades. To reduce or maintain the temperature of). In one aspect, the control circuit continues to monitor the collagen transformation temperature. Alternatively, in the embodiment shown in FIG. 65, if the transition temperature has not been reached, then process 130300 proceeds along the "no" branch and the control circuit maintains load control of clamp arm 1140 and is gripped. The rate of change in clamp arm displacement is monitored to determine when the next transition point (eg, the elastin transition point) will occur in the tissue (130310). The control circuit can do this, for example, to prevent the tissue temperature from rising above the elastin transformation temperature.

It should be understood that collagen transformation should be constant for a given heat flux (45 ° C-50 ° C). It should also be appreciated that load control of clamp arm 1140 can in some cases provide the best sealing for certain types of tissue (eg, blood vessels). During the period of collagen transformation, the temperature of the tissue should be flattened while the collagen absorbs heat. The control circuit can be configured to modulate the rate at which the data points are collected near a particular temperature or temperature of interest (eg, transformation temperature). In addition, the control circuit can adjust the amplitude of the ultrasonic transducer drive signal to control the heat flux generated by the ultrasonic blade 1128 at different points in the surgical procedure. For example, the control circuit can reduce the ultrasonic transducer amplitude during the period of collagen transformation. As another example, the control circuit can increase the amplitude of the ultrasonic transducer to measure the rate at which the temperature rises when elastin knees occur. It should be understood that the rate of temperature change decreases as the elastin knee approaches.

In another aspect, the control algorithm can be configured to detect the collagen transformation temperature and identify the collagen / elastin ratio in the grasped tissue. As mentioned above, the control algorithm can then control various operating parameters of the surgical instrument according to the identified composition of the grasped tissue.

FIG. 66 is a graphical representation of the identification of collagen transformation temperature points for identifying collagen / elastin ratios according to at least one aspect of the present disclosure. The vertical axis 130352 represents the ultrasonic transducer impedance and the horizontal axis 130632 represents the tissue temperature. The shift in the rate of change of the impedance of the ultrasonic transducer corresponds to the collagen / tissue composition of the tissue in an empirically determined manner. For example, if the rate of change in impedance of the ultrasonic transducer shifts at the first temperature 130362, the tissue composition is 100% collagen. Therefore, when the rate of change of impedance of the ultrasonic transducer shifts at the second temperature 130364, the tissue composition is 100% elastin. If the rate of change of impedance of the ultrasonic transducer shifts between the first temperature 130362 and the second temperature 130364, the tissue composition is a mixture of collagen and elastin.

The collagen transformation temperature can be used to directly identify the collagen / elastin ratio in the tissue, and the control algorithm can be configured to adjust the operation of the ultrasonic device accordingly. As shown in FIG. 66, plot 130356 represents an empirical relationship between ultrasonic transducer impedance and tissue temperature. As shown by plot 130356, the impedance (Z) of the ultrasonic transducer increases linearly at the first rate of change (gradient) as a function of temperature (T) at the tissue contact area. At the collagen transition temperature shown in the plot at point 130358, the rate of change of impedance (Z) as a function of temperature (T) decreases to a second rate of change. At point 130358 where the gradient of plot 130356 changes, the collagen to elastin ratio can correspond to an empirically determined temperature 130360 (eg, 85%). In one aspect, a control circuit or processor performing the above algorithm determines at what temperature the rate of ultrasonic converter impedance has changed, and then from memory (eg, a lookup table) the corresponding tissue composition (eg, lookup table). For example, it can be configured to search for collagen ratios, elastin ratios, or collagen / elastin ratios).

FIG. 67 is a logical flow diagram of process 130450 for identifying tissue composition according to changes in ultrasonic transducer impedance according to at least one aspect of the present disclosure. Process 130450 can be performed, for example, by a control circuit of a processor located within a surgical instrument or generator. Therefore, the control circuit monitors the impedance (Z) of the ultrasonic transducer as a function of temperature (T) (130452). As mentioned above, the temperature (T) at the interface between the tissue and the ultrasonic blade can be estimated by the algorithm described herein. The control circuit determines the rate of change ΔZ / ΔT of the ultrasonic transducer impedance (130454). As the temperature at the ultrasonic blade / tissue interface rises, the impedance (Z) increases linearly at the first rate, as shown in FIG. Therefore, the control circuit determines whether the gradient ΔZ / ΔT has changed (eg, decreased) (130456). If the gradient ΔZ / ΔT has not changed, process 130450 proceeds along the “no” branch and continues to determine the gradient ΔZ / ΔT (130454). If the gradient ΔZ / ΔT changes, the control circuit determines that the collagen transition temperature has been reached (130458).

The ratio of elastin to collagen can be determined by monitoring the collagen metamorphosis points in the tissue and comparing the detected collagen metamorphosis points with a look-up table. The look-up table can be stored in memory (eg, memory 3326 in FIG. 31) and contains the ratio of elastin to collagen and the collagen transformation points corresponding to a particular ratio empirically determined.

Adjusting Clamp Arm Force According to Tissue Position In various aspects, the control algorithm can be configured to determine the position of the tissue within or relative to the end effector and adjust the clamp arm force accordingly. In one aspect, the tissue is identified or parameterized by measuring the compressive load on the clamp arm and the location of the tissue within the jaws, eg, where the tissue is located along the length of the ultrasonic blade. can do. In one aspect, the time to initial measurement load on the clamp arm is measured, and then the compression ratio on the tissue is measured to determine the compressibility of the tissue relative to the amount of tissue located over the length of the jaws. The rate of change in the position of the clamp arm actuator is monitored during load control as a way to determine tissue compressibility and thus tissue type / disease status.

FIG. 68 is a graphical representation of the compression load distribution over the ultrasonic blade 130404 according to at least one aspect of the present disclosure. The vertical axis 130502 represents the force applied to the tissue by the clamp arm 1140, and the horizontal axis 130504 represents the position. The ultrasonic blade 130404 is sized so that there are periodic nodes and anti-nodes that occur along the length of the blade. The position of the node / anti-node is determined by the wavelength of the ultrasonic displacement induced in the ultrasonic blade 130404 by the ultrasonic converter. Ultrasonic transducers are driven by electrical signals of suitable amplitude and frequency. As is known in the art, the node is the minimum or zero displacement point of the ultrasonic blade 130404 and the antinode is the maximum displacement point of the ultrasonic blade 130404.

In the graph display 130500, the ultrasonic blades 130404 are represented such that the nodes and anti-nodes are aligned with their corresponding positions along the horizontal axis 130504. The graph display 130500 includes a first plot 130506 and a second plot 130508. As represented by either plot 130506 or 130508, the compressive force applied to the ultrasonic blade 130404 is exponentially reduced from the proximal end of the ultrasonic blade 130404 to the distal end of the ultrasonic blade 130404. Therefore, the tissue 130410 located at the distal end of the ultrasonic blade 130404 receives a much lower compressive force than the tissue 130410 located close to the proximal end of the ultrasonic blade 130404. First plot 130506 may represent a default closing of the clamp arm 1140, the resulting force applied to the distal tissue 130,410 is _{F 1.} In general, the amount of force exerted by the clamp arm 1140 on the tissue 130410 is widely increased without consideration as excessive force may be applied to the tissue 130410 located proximally along the ultrasonic blade 130404. It is not possible. However, by monitoring the position of the tissue 130410 along the ultrasonic blade 130404 (eg, the section "Positioning the tissue via impedance change" above, and "Positioning the tissue via electrode conduction" below. As discussed in the "Determining" section), the control algorithm uses the clamp arm 1140 to the tissue 130410 in situations where the tissue 130410 is located only at the distal end of the ultrasonic blade 130404, similar to the situation shown in FIG. The applied force can be amplified. For example, a second plot 130508 can represent a modified closure of the clamp arm 1140, and the control algorithm determines that the tissue 130410 is located only at the distal end of the ultrasonic blade 130404, correspondingly. The force applied by the clamp arm 1140 to the distal tissue 130410 is increased to _{F 2} (F ₂ > F _1).

FIG. 69 is a graph representation of pressure vs. time applied to tissue 130520 according to one aspect of the present disclosure. The vertical axis 130522 represents the pressure applied to the tissue (eg, N / mm ² ) and the horizontal axis 130524 represents time. The first plot 130526 represents the normal or default compressive force applied to the distal tissue 130410 without amplification. During the default closure of the clamp arm 1140, the compressive force applied to the tissue 130410 is maintained at a constant value after the initial ramp-up period. The second plot 130528 represents the amplified compressive force applied to the distal tissue 130410 to compensate for the presence of only the distal tissue 130410. In the modified closure of the clamp arm 1140, the pressure is increased compared to the default closure (130530) and the finally amplified compressive force returns to normal compression levels (130532) through the clamp arm 1140 pad. Prevents burning / melting.

Positioning Tissue Through Electrode Continuity In various aspects, the control algorithm is an electrical conduction across an array of bipolar (ie, positive and negative) electrodes positioned along the end effector jaws or jaws. Therefore, it can be configured to determine the position of the tissue within or with respect to the end effector. The position of the tissue detected by the bipolar electrode array can correspond to a specific position of the tissue relative to the jaws and / or the ratio of the jaws covered by the tissue. In one aspect, the positive and negative electrodes are separated by a physical gap so that when the tissue bridges the positive and negative electrodes, electrical conduction is established between the electrodes. The positive and negative electrodes are configured in a matrix or array, which allows the processor or control circuit to detect where tissue is located between the positive and negative electrodes by monitoring or scanning the electrode array. It can be configured as follows. In one aspect, the bipolar electrode array can be positioned along one jaw of the end effector. Thus, a control circuit or processor coupled to a bipolar electrode array can be configured to detect electrical conduction between adjacent electrodes and detect the presence of tissue in contact with it. In another aspect, the bipolar electrode array can be positioned along the opposing jaws of the end effector. Thus, a control circuit or processor coupled to a bipolar electrode array can be configured to detect electrical continuity between opposing jaws and detect the presence of tissue between them.

By determining which surface area of the jaws (s) are covered with tissue, the control algorithm determines the appropriate bonding pressure for the amount of tissue gripped by the end effector, and then the corresponding clamp arm load. Allows you to calculate. The clamp arm load can be expressed in terms of applied pressure (eg 130-180 psi) or applied force (eg 3.5-5 lbs or nominally 4.5 lbs). In some embodiments, the bipolar electrode array may deliver power from a unipolar or bipolar RF electrosurgical generator to the positive and negative electrodes. The generator power output is a function of various constants, variables, or minimum values (eg, 45W, 35W, or 5W), surgical instruments and / or various variables associated with the generator (eg, ultrasonic blades or). It may be the amplitude of the clamp arm force) or may be dictated by an algorithm for controlling the generator according to its power curve (eg, during generator ramp-up).

FIG. 70 shows an end effector 130400 containing a single jaw electrode array for detecting tissue location, according to at least one aspect of the present disclosure. In the illustrated embodiment, the end effector 130400 includes a first jaw 130430 and a second jaw 130432 having an electrode array 130431 disposed on it. The electrode array 130431 includes electrodes 130249 coupled to an energy source such as an RF generator. The end effector 130400 may include an end effector for an ultrasonic surgical instrument, the second jaw 130432 may be, for example, an ultrasonic blade 1128 (FIG. 23), an electrosurgical instrument, a surgical stapler and a cutting instrument. End effector for. The second jaw 130432 may include, for example, an ultrasonic blade 1128 (FIG. 23), or a collaborative jaw for electrosurgery or surgical staple fastening and cutting instruments. In the illustrated embodiment, the electrode array 130431 includes twelve electrodes 130249 arranged in a generally herringbone-shaped pattern. However, the number, shape, and arrangement of electrodes 130249 in the electrode array 130431 are for illustrative purposes only. Therefore, the electrode array 130431 can include various numbers, shapes, and / or arrangements of electrodes 130249. For example, the number of electrodes 130429 can be adjusted according to the desired resolution for detecting tissue position.

In one aspect, the electrode array 130431 can include electrodes 130429 separated by physical gaps, alternating in polarity, or coupled to opposite terminals of the energy source (ie, supply and return terminals). For example, in the illustrated embodiment, the even numbered electrode 130249 may be of the first polarity (eg, positive or coupled to the power supply terminal) and the odd numbered electrode 130429 may be of the second polarity. (For example, it can be negative or coupled to the return terminal of the power supply). Thus, when the tissue 130410 comes into contact with the adjacent electrode 130429, the tissue 130410 physically and electrically bridges the bipolar electrodes 130429, causing an electric current to flow between them. The current flow between the bipolar electrodes 130429 can be detected by a control algorithm executed by a control circuit or processor coupled to the electrode array 130431, whereby the control circuit or processor detects the presence of tissue 130410. To enable.

Tissue detection by electrode array 130431 can be graphically represented by an activation matrix. For example, FIG. 71 shows an activation matrix 130550 showing the location of tissue 130410 by electrode array 130431 shown in FIG. 70. The vertical axis 130554 and the horizontal axis 130555 both represent the electrodes 130439 of the electrode array 130431, and the numbers along the axes 130554 and 130555 represent the corresponding numbered electrodes 130429. Activation region 130552 indicates where conduction exists between the corresponding electrodes 130429, i.e., where tissue 130410 is present. In FIG. 70, tissue 130410 is present across the first, second, and third electrodes 130249, and as described above, electrodes 130249 can alternate polarities in some embodiments. Therefore, there is electrical conduction between the first and second electrodes 130249 and between the second and third electrodes 130249. It should be noted that in this described embodiment, there is no continuity between the first and third electrodes 130249 because of the same polarity. The conduction between these electrodes 130429 is graphically illustrated by the activation region 130552 within the activation matrix 130550. Also, the region 130555 bounded by the activation region 130552 is not shown as activation because in this described embodiment the electrode 130429 cannot have continuity with itself. Please note. The control algorithm performed by the control circuit or processor coupled to the electrode array 130431 is such that the tissue position corresponds to a particular electrode 1304929 with established electrical conduction, so that the tissue 130410 within the end effector 130400 (Because the position of the electrode 130249 is known), the proportion of jaws 130430 and 130432 of the end effector 130400 covered by the tissue 130410, and so on.

FIG. 72 shows an end effector 130400 containing a dual jaw electrode array for detecting tissue location, according to at least one aspect of the present disclosure. In the illustrated embodiment, the end effector 130400 has a first jaw 130430 having a first electrode array 130431 disposed on it and a second jaw 130433 having a second electrode array 130433 disposed on it. Includes Joe 130432. Each of the electrode arrays 130431 and 130433 contains an electrode 130249 coupled to an energy source such as an RF generator. The end effector 130400 can include end effectors for electrosurgical instruments, end effectors for surgical staples and cutting instruments, and the like. As mentioned above, the number, shape, and / or arrangement of electrodes 130249 can vary in various ways. For example, in FIG. 75, the electrode arrays 130431 and 130433 are arranged in an overlapping tiled or rectangular pattern.

In one aspect, the opposing electrodes 130439 of the electrode arrays 130431 and 130433 are separated by a physical gap, and each electrode array 130431, 130433 has opposite polarity or the opposite terminals of the energy source (ie, supply terminals). And the return terminal). For example, in the illustrated embodiment, the first electrode array 130431 can be of the first polarity (eg, positive or coupled to the power supply terminal) and the second electrode array 130433 is the second. Polarity (eg, negative electrode or coupled to the return terminal of the power supply). Thus, when the tissue 130410 comes into contact with each of the electrodes 130439 of the opposing electrode arrays 130431 and 130433, the tissue 130410 physically and electrically bridges the bipolar electrodes 130429 and allows current to flow between them. The current flow between the bipolar electrodes 130429 can be detected by a control algorithm executed by a control circuit or processor coupled to the electrode array 130431, 130433, whereby the control circuit or processor detects the presence of tissue 130410. Allows you to.

As mentioned above, the activation matrix can graphically represent the presence of tissue. For example, FIG. 73 shows an activation matrix 130556 indicating the location of tissue 130410 as shown in FIG. 74. The vertical axis 130557 represents the electrode 130429 of the first electrode array 130431, the horizontal axis 130558 represents the electrode 130249 of the second electrode array 130433, and the number along the axis 130557 and 130558 is each electrode array 130431, 130433. Represents the corresponding numbered electrode 130249 of. Activation region 130552 indicates where conduction exists between the corresponding electrodes 130429, i.e., where tissue 130410 is present. In FIG. 74, the tissue 130410 is the first, second, and third electrodes 130431a, 130431b, 130431c of the first electrode array 130431, and the first, second, and third electrodes 130433 of the second electrode array 130433. It is positioned in contact with the electrodes 130433a, 130433b and 130433c. Thus, there is electrical conduction between each of these pairs of electrodes in the opposing electrode arrays 130431 and 130433, as current can flow between these pairs of opposing electrodes. Electrodes in the presence of conduction due to the location of the gripped tissue 130410 are graphically represented by activation region 130552 within the activation matrix 130556 of FIG. 73. Further, the tissue 130410 includes the fourth, fifth, and sixth electrodes 130431d, 130431e, 130431f of the first electrode array 130431, and the fourth, fifth, and sixth electrodes 130433d of the second electrode array 130433. Since it is not positioned with respect to 130433e and 130433f, there is no electrical conduction between these electrodes. The control algorithm performed by the control circuit or processor coupled to the electrode array 130431, 130433 is within the end effector 130400 because the tissue location corresponds to a particular electrode 130429 with established electrical conduction. Configured to estimate the location of tissue 130410 (because the location of electrode 130249 is known, as shown in FIG. 74), the proportion of jaws 130430, 130432 of the end effector 130400 covered by tissue 130410, and so on. can do. In the illustrated embodiment, the activated electrodes of the first and second electrode arrays 130431, 130433 are electrodes 1304929 in which tissue 130410 is located overlapping and placed between them.

In another aspect, the end effector can be configured to transmit multiple signals or pings at various frequencies, and the electrode array each detects a particular frequency signal or a signal via frequency conversion. Can be coupled to the circuit, including the corresponding bandpass filter. Various parts of the electrode array circuit can include bandpass filters tuned to different frequencies. Therefore, the position of the tissue gripped by the end effector corresponds to a particular detected signal. The signal can be transmitted, for example, at non-therapeutic frequencies (eg, at frequencies beyond the therapeutic frequency range of RF electrosurgical instruments). The electrode array circuit can include, for example, a flex circuit.

FIG. 75 is an end effector according to at least one aspect of the present disclosure, comprising a first jaw 130430 having a first segmented electrode array 130431 and a second jaw 130432 having a second segmented electrode array 130433. 130400 is shown. In addition, FIG. 76 shows the tissue 130410, which is placed on the second jaw 130432 and is gripped by the end effector 130400. In one aspect, the first electrode array 130431 is configured to transmit signals at various frequencies (eg, non-therapeutic frequencies) and the second electrode array 130433 is tissue 130410 gripped by the end effector 130400. It is configured to receive signals through (ie, when tissue 130410 is in contact with both electrode arrays 130431 and 130433). The second electrode array 130433 can include segmented electrode array circuits 130600 as shown in FIG. 77, and each circuit segment has a bandpass filter 130601 coupled to each electrode 130602 of the second electrode array 130433. Including. Each bandpass filter 130601 can include one or more capacitors 130604 and one or more inductors 130606, and the number, arrangement, and values of the capacitors 130604 and inductor 130606 are each bandpass filter. 130601 can be selected to tune to a particular frequency or frequency band. The structure 130410 functions as a signal conduction medium between the electrode arrays 130431 and 130433, and different parts of the second electrode array 130433 are tuned to detect signals of different frequencies (differently tuned bandpasses). Since (via filter 130601), the control algorithm executed by the control circuit or processor coupled to the electrode array 130431, 130433 is configured to estimate the position of tissue 130410 according to which signal is detected by it. be able to. In the illustrated embodiment, the electrode array 130431, 130433 comprises six electrode segments 130602 generally arranged in a tiled pattern with semi-circular end segments, however, of the electrodes 130602 in the electrode array 130431, 130433. The numbers, shapes, and sequences are for illustrative purposes only. Therefore, the electrode array 130431, 130433 can include various numbers, shapes, and / or arrangements of electrodes 130602. For example, the number of electrodes 130602 can be adjusted according to the desired resolution for detecting tissue position.

FIG. 78 is a graphical representation of the frequency response 130610 corresponding to the tissue 130410 gripped in FIG. 76 according to at least one aspect of the present disclosure. The vertical axis 130652 represents the amplitude and the horizontal axis 130654 represents the RF frequency. In one embodiment, the second electrode array 130 433, the first center frequency _{f S1} (e.g., 5 MHz) a first electrode circuit segments 130602a tuned to a frequency band defined by a second center frequency _{f S2} ( for example, the third electrode circuit segments tuned to a frequency band which is defined a second electrode circuit segments 130602b tuned to a frequency band defined by a third center frequency _{f S3} (e.g., 15 MHz) by 10 MHz) Includes 130602c and a fourth electrode circuit segment 130602d tuned to a frequency band defined by a fourth center frequency f _{S4 (eg, 20 MHz).} As shown in FIG. 78, the sensing frequency band is _{above the therapeutic frequency range 130656 defined by f T1} (eg, 300 kHz) to f _T2 (eg, 500 kHz) and / or preferred therapeutic frequency (eg, 350 kHz). The frequency range 130658 is defined. In one aspect, the central sensing frequencies f _S1 , f _S2 , f _S3 , and f _S4 within the sensing frequency range 130658 are each separated by a defined frequency value (eg, 5 MHz). Further, the sensing frequency range 130658 is shown to include four sensing frequency bands, but this is for illustrative purposes only. In the illustrated embodiment, the gripped tissue 130410 is in contact with the second, third, and fourth electrode circuit segments 130602b, 130602c, 130602d. Therefore, the detected frequency response includes peaks 130655b, 130655c, 130655d at each of the corresponding frequencies. Therefore, the control algorithm can estimate the position of the tissue 130410 from the detected frequency response, i.e. the control circuit is that the tissue 130410 has the second, third, and fourth electrode circuit segments 130602b, 130602c. It can be determined that it is positioned within the end effector 130400 so that it contacts 130602d and does not contact other circuit segments. Therefore, the control algorithm can estimate the position of tissue 130410 with respect to jaws 130430 and 130432 of the end effector 130400 and / or the ratio of jaws 130430 and 130432 in contact with tissue 130410.

Adaptive Ultrasonic Blade Temperature Monitoring In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust various parameters of the ultrasonic system based on the temperature of the ultrasonic blade. Operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm can include, for example, the amplitude of the ultrasonic blade, the control signal driving the ultrasonic converter, the pressure applied by the clamp arm, and the like. .. The adaptive ultrasonic blade control algorithm can be executed by a control circuit or processor located in either the generator or the surgical instrument.

In one example described in more detail below, an adaptive ultrasonic blade control algorithm dynamically monitors the temperature of the ultrasonic blade and is provided to the ultrasonic blade amplitude and / or ultrasonic converter accordingly. Adjust the signal. In another example, described in more detail below, the adaptive ultrasonic blade control algorithm dynamically monitors the temperature of the ultrasonic blade and adjusts the clamp arm pressure accordingly. The adaptive ultrasonic blade control algorithm measures the temperature of the ultrasonic blade through various techniques, such as by analyzing the frequency spectrum of the ultrasonic converter, as discussed in the "Temperature Estimate" section above. be able to. Another technique for determining the temperature of the ultrasonic blade uses non-contact imaging. These and other techniques are described in detail herein, and additional details can be found in US Patent Provisional Application No. 62 / 692,768 entitled "SMART ENERGY DEVICES".

Adjusting Ultrasonic System Parameters According to Temperature In one aspect, the adaptive ultrasonic blade control algorithm can be configured to adjust the operating parameters of the ultrasonic system based on the temperature of the ultrasonic blade. As mentioned above in the section "Temperature estimation", the intrinsic frequency of the ultrasonic blade / converter moves with the temperature, so the temperature of the ultrasonic blade is the voltage signal applied to drive the ultrasonic converter. It can be estimated from the phase angle between the current signal and the current signal. In addition, the ultrasonic blade temperature corresponds to the tissue temperature. In some embodiments, the adaptive ultrasonic blade control algorithm can be configured to detect the ultrasonic blade temperature and modulate the operating parameters of the surgical instrument according to that temperature. The operating parameters are applied by, for example, the frequency of the ultrasonic converter drive signal, the amplitude of the ultrasonic blade (for example, the magnitude or amplitude of the current supplied to the ultrasonic converter), and the clamp arm. The pressure to be applied, etc. can be included. The adaptive ultrasonic blade control algorithm can be executed by a control circuit or processor located in either the generator or the surgical instrument.

Thus, in one aspect, the adaptive ultrasonic blade control algorithm detects the resonant frequency of the ultrasonic blade and then detects the modal shift of the resonant frequency waveform, as previously described in the "Temperature Estimate" section. Therefore, the resonance frequency is monitored over time. The shift of the resonant waveform can correlate with the occurrence of system changes such as an increase in the temperature of the ultrasonic blade. In some embodiments, the adaptive ultrasonic blade control algorithm can be configured to adjust the amplitude of the ultrasonic drive signal, and thus the amplitude of the ultrasonic blade displacement, in order to measure the temperature of the tissue. In another aspect, the adaptive ultrasonic blade control algorithm keeps the temperature of the ultrasonic blade and / or tissue within a predetermined temperature or a predetermined threshold (eg, the temperature of the ultrasonic blade has become too high). Configured to control the amplitude of the ultrasonic drive signal, and thus the amplitude of the ultrasonic blade displacement, according to the temperature of the ultrasonic blade and / or tissue (to allow the ultrasonic blade to cool in some cases). Can be done. In yet another aspect, the adaptive ultrasonic blade control algorithm depends on the tissue impedance, tissue temperature, and / or ultrasonic blade temperature, for example, to minimize temperature overshoot or to reduce the heat flux of the ultrasonic blade. It can be configured to modulate the RF power and waveform of the electrosurgical instrument for modification. Further details regarding these and other functions are described, for example, with reference to FIGS. 95-100.

FIG. 79 is a graph representation of the frequency of the ultrasonic converter system 130700 as a function of drive frequency and ultrasonic blade temperature drift, according to at least one aspect of the present disclosure. The horizontal axis 130704 represents the drive frequency (eg, Hz) applied to the ultrasonic system (eg, ultrasonic converter and / or ultrasonic blade), and the vertical axis 130702 represents the resulting impedance phase angle (eg, eg Hz). , Radian). The first plot 130706 represents the characteristic resonant waveform of the ultrasonic system at normal or ambient temperature. As can be seen in the first plot 130706, the ultrasonic system is _{in phase when driven at the excitation frequency fe} (because the impedance phase angle is near 0 radians or 0 radians). Therefore, _fe represents the resonant frequency of the ultrasonic system at ambient temperature. The second plot 130708 represents the characteristic waveform of the ultrasonic system when the temperature of the ultrasonic system rises. As shown in FIG. 79, as the temperature of the ultrasonic system rises, the characteristic waveforms of the ultrasonic blades and ultrasonic converters (shown by the first plot 130706) are on the left, eg, lower frequencies. Shift to the range. Due to the shift of the frequency waveform of the ultrasonic system, the ultrasonic system is no longer in phase when driven at the _{excitation frequency fe.} Rather, the resonant frequency shifts low to f'e. Therefore, the control circuit connected to the ultrasonic system is out of phase with the ultrasonic system by detecting changes in the resonance frequency of the ultrasonic system and / or when driven at a previously established resonance frequency. By detecting the presence, the temperature change of the ultrasonic system can be detected or estimated.

Correspondingly, in some embodiments, the control circuit connected to the ultrasonic system is turned into the ultrasonic system by the generator according to the estimated temperature of the ultrasonic system in order to keep the ultrasonic system in phase. It can be configured to control the applied drive signal. Keeping the ultrasonic system in phase can be used, for example, to control the temperature of the ultrasonic system. As described above, as the temperature of the ultrasonic blade and / or ultrasonic transducer rises, the resonance frequency at which the voltage and current signals are in phase _{changes from fe} (eg, 55.5 kHz) to f'e at normal temperature. Shift to. Therefore, as the temperature of the ultrasonic system rises, the control circuit controls the generator to _{shift the frequency at which the ultrasonic system is driven from fe} to f'e, causing the ultrasonic system to drive the generator signal. Can be maintained in phase with. For a further description of the adaptive ultrasonic blade control algorithm, see the description related to FIGS. 43A-54 above.

FIG. 80 is a graph representation of the temperature of the ultrasonic transducer as a function of time 130750, according to at least one aspect of the present disclosure. The vertical axis 130752 represents the temperature of the ultrasonic transducer, and the horizontal axis 130754 represents the time. In one aspect, when the ultrasonic converter temperature (represented by plot 130756) _{meets or exceeds the temperature threshold T 1} , the adaptive ultrasonic blade control algorithm controls the ultrasonic converter to perform ultrasonic conversion. maintaining the temperature of the vessel to the threshold temperature T ₁ of less. The adaptive ultrasonic blade control algorithm can control the temperature of the ultrasonic converter, for example, by modulating the power and / or drive signal applied to the ultrasonic converter. Further description of algorithms and techniques for controlling the temperature of ultrasonic blades / converters is described herein by reference to the sections "Feedback Control" and "Ultrasonic Encapsulation Algorithms with Temperature Control", and disclosure thereof. It can be found in US Patent Provisional Application No. 62 / 640,417 filed on March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR" incorporated in.

FIG. 81 is a graph representation of the modal shift of the resonance frequency based on the temperature of the ultrasonic blade that moves the resonance frequency as a function of the temperature of the ultrasonic blade according to at least one aspect of the present disclosure. In the first graph 130800, the vertical axis 130802 represents the change in resonance frequency (Δf), and the horizontal axis 130804 represents the ultrasonic transducer drive frequency of the generator. In the second, third, and fourth graphs 130810, 130820, 130830, the vertical axes 130812, 130822, 130832 represent frequency (f), current (I), and temperature (T), respectively, and the horizontal axes 130814, 130824. 130834 represents time (t). The first graph 130810 represents the frequency shift of the ultrasonic system due to temperature changes. The second graph 130820 represents the current or amplitude adjustment in the ultrasonic transducer to maintain a stable frequency and temperature. The third graph 130830 represents the temperature change of the tissue and / or ultrasonic system. The set of graphs 130800, 130810, 130820, 130830 also demonstrates the functionality of a control algorithm configured to control the temperature of the ultrasonic system.

Control algorithm may be configured to control the ultrasound system when the temperature of the ultrasound system is close to the temperature threshold T ₁ (for example, ultrasonic transducers and / or ultrasound blades). In one embodiment, the control algorithm may be configured to determine the resonance frequency of the ultrasound system according to whether dropped by the threshold Delta] f _R, or temperature thresholds T ₁ is approaching, or has reached. As shown by the first graph 130800, the frequency change threshold Δf _{R corresponding to the threshold temperature T 1} is also a function of _{the drive frequency f D} of the ultrasonic system (as represented by plot 130806). possible. As the temperature of the tissue and / or ultrasonic blade increases (represented by the temperature plot 130836), the resonant frequency decreases accordingly (as shown by the second graph 130810 and the fourth graph 130830). (Represented by frequency plot 130816). As the temperature plot 130836 approaches the temperature threshold T ₁ (eg 130 ° C.) _{at time t 1} , the resonant frequency drops from f _{1 to f 2} and the resonant frequency reaches the frequency change threshold Δf _{R of the control algorithm.} This causes the control algorithm to act to stabilize the ultrasonic system temperature. By monitoring changes in the resonant frequency of the ultrasonic system, the adaptive ultrasonic blade control algorithm can thereby monitor the temperature of the ultrasonic system. Furthermore, the adaptive ultrasonic blade control algorithm, when the temperature is satisfied or exceeds the threshold value T _1, in order to stabilize the temperature and / or the resonance frequency of the tissue and / or ultrasonic blade, applied to the ultrasonic transducer The current produced can be adjusted (eg, reduced) or otherwise configured to adjust the amplitude of the ultrasonic blade (represented by current plot 130826).

In another aspect, the adaptive ultrasonic blade control algorithm, when the temperature is satisfied or exceeds the threshold value T _1, it can be configured to adjust the pressure applied to the tissue by the clamping arms (e.g., decrease) .. In various other aspects, the adaptive ultrasonic blade control algorithm can be configured to adjust various other operating parameters associated with the ultrasonic system according to temperature. In another aspect, the adaptive ultrasonic blade control algorithm can be configured to monitor multiple temperature thresholds. For example, the second temperature threshold T ₂ can represent, for example, the melting or failure temperature of the clamp arm. Therefore, the adaptive ultrasonic blade control algorithm can be configured to behave the same or differently according to a particular temperature threshold that is met or exceeded.

In various embodiments, non-contact imaging can be used to determine the temperature of the ultrasonic blade in addition to or instead of the techniques described above. For example, shortwave thermography can be used to measure blade temperature by imaging the blade from a stationary surrounding location via a CMOS imaging sensor. Tissue temperature may be controlled using thermographic non-contact monitoring of the temperature of the ultrasonic waveguide or ultrasonic blade. In another aspect, non-contact imaging can be used to determine the surface condition and finish of the ultrasonic blade and near IR detection techniques can improve the tissue and / or the temperature of the ultrasonic blade.

Determining Joe's Condition The challenge with ultrasonic energy delivery is that ultrasonic sound applied to the wrong material or wrong tissue can cause equipment failure, such as melting of the clamp arm pad or damage to the ultrasonic blade. It can be the result. It is also desirable to detect what is located in the jaw of the end effector of the ultrasonic device and the state of the jaw without adding an additional sensor in the jaw. Positioning the sensor within the jaws of an ultrasonic end effector poses reliability, cost, and complexity issues.

Ultrasound Spectroscopy Smart Blade Algorithm Technology is the impedance of an ultrasonic transducer configured to drive an ultrasonic transducer blade according to at least one aspect of the present disclosure.

に基づいて、ジョーの状態（クランプアームパッドの溶け落ち、ステープル、破損ブレード、ジョー内の骨、ジョー内の組織、ジョーを閉じた状態でのバックカットなど）を推定するために用いられてもよい。インピーダンスＺ_ｇ（ｔ）、大きさ｜Ｚ｜、及び位相φは、周波数ｆの関数としてプロットされる。

Also used to estimate the condition of the jaws (clamp arm pad melt-off, staples, broken blades, bone in the jaws, tissue in the jaws, backcuts with the jaws closed, etc.) Good. Impedance Z _g (t), magnitude | Z |, and phase φ are plotted as a function of frequency f.

Also known as Dynamic Mechanical Analysis (DMA), Dynamic Mechanical Spectroscopy or Simply Mechanical Spectroscopy, is a technique used to study and characterize materials. Sine wave stress is applied to the material and the strain in the material is measured, allowing the determination of the complex modulus of the material. Spectroscopy applied to an ultrasonic device involves exciting the tip of an ultrasonic blade with a frequency sweep (synthetic signal or conventional frequency sweep) and measuring the resulting complex impedance at each frequency. Complex impedance measurements of ultrasonic converters over a frequency range are used in classifiers or models to estimate the characteristics of ultrasonic end effectors. In one aspect, the present disclosure provides techniques for determining the state of an ultrasonic end effector (clamp arm, jaw) to facilitate automation of an ultrasonic device (eg, of power to protect the device). Invalidation, execution of adaptive algorithms, retrieval of information, organization identification, etc.).

_{FIG. 82 shows various different states and conditions of the end effector in which impedance Z g} (t), magnitude | Z |, and phase φ are plotted as a function of frequency f according to at least one aspect of the present disclosure. It is the spectrum 132030 of the ultrasonic apparatus which has. The spectrum 132030 is plotted in three-dimensional space, the frequency (Hz) is plotted along the x-axis, the phase (radians) is plotted along the y-axis, and the magnitude (ohm) is plotted along the z-axis. Has been done.

Spectral analysis of different jawbites and device states produces different complex impedance characteristic patterns (fingerprints) over the frequency range of different conditions and states. Each state or condition has a different characteristic pattern in 3D space when plotted. These characteristic patterns can be used to estimate the conditions and states of the end effector. FIG. 82 shows the spectra of air 132032, clamp arm pads 132304, chamois leather 132036, staples 132038, and broken blades 132040. Chamois leather 132036 is obtained used to characterize different types of tissue.

The spectrum 132030 can be evaluated by applying a low power electrical signal across the ultrasonic transducer to generate a non-therapeutic excitation of the ultrasonic blade. The low power electrical signal uses the FFT to provide the impedance of the entire ultrasound transducer in the series (sweep) or parallel (composite signal) frequency range.

を測定するために、掃引又は合成フーリエ級数の形で適用することができる。

Can be applied in the form of a sweep or synthetic Fourier series to measure.

New Data Classification Methods For each characteristic pattern, parametric lines should be adapted to the data used for training using polynomials, Fourier series, or any other form of parametric equations that can be conveniently defined. Can be done. New data points are then received and classified by using the Euclidean vertical distance from the new data points to the orbits fitted to the characteristic pattern training data. The vertical distance from the new data point to each orbit (each orbit represents a different state or condition) is used to assign the point to the state or condition.

The probability distribution of the distance from each point in the training data to the fitted curve can be used to estimate the probability of a new accurately classified data point. This essentially constructs a two-dimensional probability distribution in a plane perpendicular to the fitted orbit at each new data point of the fitted orbit. The new data points are then included in the training set based on the probability of correct classification to easily detect high frequency changes in state, but deviations that occur in system performance, such as dirty equipment or worn pads. Adaptive learning classifiers that adapt to delay can be created.

_{FIG. 83 is a set of 3D training data in which the ultrasonic converter impedance Zg} (t), magnitude | Z |, and phase φ are plotted as a function of frequency f according to at least one aspect of the present disclosure. It is a graph display of the plot 1302042 of the set (S). In the 3D training dataset (S) plot 1302042, the phase (radian) is plotted along the x-axis, the frequency (Hz) is plotted along the y-axis, and the magnitude (ohm) is plotted along the z-axis. It is graphically shown in the three-dimensional space, and the parametric Fourier series is applied to the 3D training data set (S). The method for classifying the data is based on a 3D training dataset (S0 is used to generate plot 1302042).

The parametric Fourier series that applies to the 3D training data set (S) is given by the following equation.

New point

について、

about,

までの垂直距離は、次式よって見出される。

The vertical distance to is found by the following equation.

次の場合、

In the following cases

すると、
Ｄ＝Ｄ_⊥

Then
D = D _⊥

Data points belonging to group S using the probability distribution of D

の確率を推定することができる。

The probability of

Controls Various automated tasks and safety measures can be implemented based on the classification of data measured before, during, or after activation of the ultrasonic transducer / ultrasonic blade. Similarly, the condition of the tissue located in the end effector and the temperature of the ultrasonic blade can be estimated to some extent, and it is used to better inform the user of the condition of the ultrasonic device or to protect important structures. You can also do it. The temperature control of the ultrasonic blades is a co-owned US patent tentatively filed on March 8, 2018, entitled "TEMPERATURE CONTOROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR", which is incorporated herein by reference in its entirety. It is described in Application No. 62 / 640,417.

Similarly, when the ultrasonic blade is likely to be in contact with the clamp arm pad (eg, without tissue in between), or the ultrasonic blade is damaged, or the ultrasonic blade is metal (eg, staple). ), The power delivery can be reduced. In addition, backcuts can be prohibited if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad.

Integration of other data to improve classification This system uses probability functions and Kalman filters to combine data from this process with the data described above to include sensors, users, patient metrics, environmental factors, etc. Can be used with other information provided by. The Kalman filter determines the maximum likelihood of a condition or condition that occurs in light of various uncertain measurements of reliability. Since this method allows the assignment of probabilities to newly classified data points, the information in this algorithm can be implemented using other measurements or estimates within the Kalman filter.

FIG. 84 is a logical flow of a process showing a control program or logical configuration for determining the state of jaws based on a complex impedance pattern (fingerprint) according to at least one aspect of the present disclosure. Before determining the jaw state based on the complex impedance characteristic pattern (fingerprint), the database includes, but is not limited to, air 132032, clamp arm pad 132034, chamois leather 132036, as shown in FIG. Reference complex impedance characteristic patterns or training datasets (S) are populated that characterize different jaw states, including staples 132038, broken blades 132040, and different tissue types and states. Full bite or chip, dry or moist chamois leather may be used to characterize different types of tissue. The data points used to generate the reference complex impedance characteristic pattern or training data set (S) apply a drive signal below the therapeutic level to the ultrasonic converter and from below resonance over a predetermined frequency range. Obtained by sweeping the drive frequencies up, measuring the complex impedance at each frequency, and recording the data points. The data points are then fitted to the curve using various numerical techniques including polynomial curve fitting, Fourier series, and / or parametric equations. Parametric Fourier series that apply to the reference complex impedance characteristic pattern or training data set (S) are described herein.

When the reference complex impedance characteristic pattern or training data set (S) is generated, the ultrasonic instrument measures new data points, classifies the new points, and sets the new data points as the reference complex impedance characteristic pattern or training data. It is determined whether or not it should be added to the set (S).

Here, referring to the logic flow diagram of FIG. 84, in one aspect, the processor or control circuit measures the complex impedance of the ultrasonic converter (132046), where the complex impedance is:

として定義される。プロセッサ又は制御回路は、複素インピーダンス測定データ点を受信し（１３２０４８）、複素インピーダンス測定データ点を基準複素インピーダンス特性パターン内のデータ点と比較する（１３２０５０）。プロセッサ又は制御回路は、比較分析の結果に基づいて複素インピーダンス測定データ点を分類し（１３２０５２）、比較分析の結果に基づいて、エンドエフェクタの状態又は条件を割り当てる（１３２０５４）。

Is defined as. The processor or control circuit receives the complex impedance measurement data points (132048) and compares the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern (132050). The processor or control circuit classifies complex impedance measurement data points based on the results of the comparative analysis (132052) and assigns end effector states or conditions based on the results of the comparative analysis (132054).

In one aspect, the processor or control circuit receives a reference complex impedance characteristic pattern from a database or memory attached to the processor. In one aspect, the processor or control circuit produces a reference complex impedance characteristic pattern as follows: The drive circuit connected to the processor or control circuit starts at the initial frequency, ends at the final frequency, and applies a non-therapeutic drive signal to the ultrasonic transducer at multiple frequencies in between. The processor or control circuit measures the impedance of the ultrasonic converter at each frequency and stores the data points corresponding to each impedance measurement. The processor or control circuit fits multiple data points into a curve to generate a three-dimensional curve that represents a reference complex impedance characteristic pattern, where magnitude | Z | and phase φ are plotted as a function of frequency f. .. Curve fitting includes polynomial curve fitting, Fourier series, and / or parametric equations.

In one aspect, the processor or control circuit receives a new impedance measurement data point and uses the new impedance using the Euclidean vertical distance from the new impedance measurement data point to the orbit fitted to the reference complex impedance characteristic pattern. Classify the measurement data points. The processor or control circuit estimates the probability that the new impedance measurement data points will be correctly classified. The processor or control circuit adds the new impedance measurement data points to the reference complex impedance characteristic pattern based on the estimated correct classification probability of the new impedance measurement data points. In one aspect, the processor or control circuit classifies the data based on the training dataset (S), which contains multiple complex impedance measurement data and is trained using parametric Fourier series. The dataset (S) is curve-fitted, where S is defined, and the probability distribution is used to estimate the probability of new impedance measurement data points belonging to group S.

Further details regarding determining or estimating the condition of jaws or surgical instruments as a whole can be found in US Patent Provisional Application No. 62 / 692,768 entitled "SMART ENERGY DEVICES".

Situational Awareness With reference to FIG. 85, a timeline 5200 indicating situational awareness of a hub, such as a surgical hub 106 or 206 (FIGS. 1 to 11), is shown. Timeline 5200 is an exemplary surgical procedure and contextual information that the surgical hubs 106, 206 can derive from data received from a data source at each step of the surgical procedure. Timeline 5200 is taken by nurses, surgeons, and other healthcare professionals in the process of lung segment resection surgery, which begins with the establishment of an operating room and ends with the transfer of the patient to the postoperative recovery room. Here is a typical process that would be.

Situation Aware Surgical Hubs 106, 206 are data sources that include data generated each time a healthcare professional uses a modular device paired with Surgical Hubs 106, 206 throughout the surgical procedure. Receive from. Surgical hubs 106, 206 receive this data from paired modular devices and other data sources to receive new data such as which step of the procedure is being performed at any given time. Once done, estimates (ie, contextual information) about ongoing treatment can be continuously derived. The situation-aware system of surgical hubs 106, 206, for example, records data about the procedure to generate a report, validates the steps taken by healthcare professionals, data that may be relevant to a particular procedure step, or Providing a prompt (eg, via a display screen), adjusting a modular device based on context (eg, activating a monitor, adjusting the visibility (FOV) of a medical imaging device, or for ultrasound surgery It is possible to perform any of the above operations, such as changing the energy level of the instrument or RF electrosurgical instrument).

As a first step 5202 in this exemplary procedure, the hospital staff reads the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, surgical hubs 106, 206 determine that the procedure performed is a thoracic procedure.

In the second step 5204, the staff scans incoming medical supplies for treatment. Surgical hubs 106, 206 cross-reference the scanned supplies with a list of supplies used in various types of procedures to ensure that the mix of supplies corresponds to the thoracic procedure. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge-shaped procedure (the incoming supplies do not contain the specific supplies required for the thoracic wedge-shaped procedure, or otherwise the thoracic Either because it does not support wedge-shaped treatment).

In step 5206, the healthcare professional scans the patient's band via a scanner communicatively connected to the surgical hubs 106, 206. Subsequently, the surgical hubs 106, 206 can confirm the patient's identification information based on the scanned data.

In step 4 5208, the medical staff turns on the assistive device. Auxiliary devices utilized may vary depending on the type of surgical procedure and the technique used by the surgeon, but in this exemplary case, these include smoke evacuators, inhalers, and medical imaging devices. Upon activation, the modular device, the auxiliary device, can be automatically paired with surgical hubs 106, 206 located within a particular neighborhood of the modular device as part of its initialization process. .. The surgical hubs 106, 206 can then derive contextual information about the surgical procedure by detecting the type of modular device paired with it before or during this initialization phase. In this particular embodiment, surgical hubs 106, 206 determine that the surgical procedure is VATS surgery based on this particular combination of paired modular devices. Based on the combination of data from the patient's EMR, the list of medical supplies used in the surgery, and the type of modular device connected to the hub, the surgical hubs 106, 206 generally describe the specific procedure performed by the surgical team. Can be estimated. When the surgical hubs 106, 206 know what specific procedure is being performed, the surgical hubs 106, 206 are subsequently connected, reading the procedure steps from memory or from the cloud. Data subsequently received from other data sources (eg, modular and patient monitoring devices) can be cross-referenced to estimate which step of the surgical procedure is being performed by the surgical team.

In the fifth step 5210, the staff attaches the EKG electrode and other patient monitoring device to the patient. EKG electrodes and other patient monitoring devices can be paired with surgical hubs 106, 206. When the surgical hubs 106, 206 start receiving data from the patient monitoring device, the surgical hubs 106, 206 confirm that the patient is in the operating room.

In step 5212, the healthcare professional induces anesthesia in the patient. Surgical hubs 106, 206 indicate that the patient is under anesthesia, based on data from modular and / or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Can be estimated. When the sixth step 5212 is completed, the preoperative part of the lung segment resection surgery is completed and the surgical part is started.

In step 5214, the operated patient's lungs are collapsed (while ventilation is switched to the contralateral lungs). Surgical hubs 106, 206 can, for example, estimate from ventilator data that the patient's lungs have collapsed. Surgical hubs 106, 206 can compare the detection of collapse of the patient's lungs with the expected steps of the procedure (which can be pre-accessed or read) so that the surgical portion of the procedure It can be presumed that it has begun, thereby collapsing the lungs, which can be determined to be the first surgical step in this particular procedure.

In the eighth step 5216, a medical imaging device (eg, a scope) is inserted and a video image from the medical imaging device is started. Surgical hubs 106, 206 receive medical imaging device data (ie, video or image data) through a connection to a medical imaging device. Upon receiving the medical imaging device data, the surgical hubs 106, 206 can determine that the laparoscopic portion of the surgical procedure has begun. In addition, surgical hubs 106, 206 can determine that the particular procedure being performed is a segmental resection as opposed to a lobectomy (in the data received in the second step 5204 of the procedure). Note that the wedge procedure has already been discounted by the surgical hubs 106, 206). The data from the medical imaging device 124 (FIG. 2) has been used (ie, activated) by determining the angle of the medical imaging device that is oriented with respect to the visualization of the patient's anatomy. Of many different methods, including by monitoring the number or medical imaging device (paired with surgical hubs 106, 206) and by monitoring the type of visualization device used. Can be used to determine contextual information about the type of treatment being performed from. For example, one technique for performing a VATS lobectomy is to place the camera above the diaphragm in the anterior inferior corner of the patient's chest cavity, while one technique for performing a VATS segmental resection is a camera. Is placed at the anterior intercostal position with respect to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situation recognition system can be trained to recognize the location of a medical imaging device based on a visualization of the patient's anatomical structure. As another example, one technique for performing VATS lobectomy utilizes a single medical imaging device, while another technique for performing VATS segmental resection utilizes multiple cameras. As yet another example, one technique for performing VATS segmental resection uses an infrared light source (which can be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental fissures. , This is not used in VATS lobectomy. By tracking any or all of this data from a medical imaging device, surgical hubs 106, 206 are used for a particular type of surgical procedure in progress and / or a particular type of surgical procedure. You can determine which technology you have.

In step 5218, the surgical team initiates the procedure incision step. The surgical hubs 106, 206 are presumed to be in the process of the surgeon incising and separating the patient's lungs to receive data from the RF or ultrasound generator indicating that the energy device is being fired. Can be done. Surgical hubs 106, 206 cross-reference the received data with the read process of the surgical procedure and the energy fired at this point in the process (ie, after the procedure of the procedure described above is complete). It can be determined that the instrument is compatible with the incision process. In certain examples, the energy instrument can be an energy tool attached to the robot arm of a robotic surgical system.

In step 10 5220, the surgical team proceeds to the procedure ligation step. Since the surgical hubs 106, 206 receive data from surgical staples and cutting instruments indicating that the instrument is being fired, it can be presumed that the surgeon is ligating the arteries and veins. Similar to the previous step, surgical hubs 106, 206 can derive this estimate by cross-referencing the reception of data from surgical staples and cutting instruments with the steps in the read process. .. In certain examples, the surgical instrument can be a surgical tool attached to the robot arm of a robotic surgical system.

In step 5222, a segmental excision portion of the procedure is performed. Surgical hubs 106, 206 can be presumed that the surgeon is making a transverse incision in parenchymal tissue based on data from surgical staples and cutting instruments, including data from the cartridge. The data in the cartridge can correspond, for example, to the size or type of staple fired by the instrument. Since different types of staples are utilized for different types of tissue, the cartridge data can indicate the type of tissue that is stapled and / or traversed. In this case, the type of staple fired is used for parenchymal tissue (or other similar tissue type), thereby presuming that surgical hubs 106, 206 are performing a segmental resection of the procedure. Can be done.

Subsequently, in the twelfth step 5224, a nodule incision step is performed. Surgical hubs 106, 206 are presumed to have a surgical team incising a nodule and performing a leak test based on data received from a generator indicating that an RF or ultrasonic instrument is being fired. Can be done. For this particular procedure, the RF or ultrasound instrument used after the parenchymal tissue has been transversely incised corresponds to a nodular incision process that allows the surgical hubs 106, 206 to make this estimate. It will be possible. Surgeons regularly staple / cut instruments and surgical energy (ie, RF or ultrasound), depending on the particular step during the procedure, because different instruments better fit to a particular task. ) Note that it alternates between the instrument and the device. Thus, the particular sequence in which stapled / cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. In addition, in certain cases, robotic tools can be used for one or more steps during a surgical procedure and / or handheld surgical instruments for one or more steps during a surgical procedure. Can be used. The surgeon (s) can, for example, alternate between robotic tools and handheld surgical instruments in sequence and / or, for example, the devices can be used simultaneously. Upon completion of the twelfth step 5224, the incision is closed and the postoperative portion of the procedure begins.

In step 5226, the patient's anesthesia is reversed. Surgical hubs 106, 206 can be estimated, for example, based on ventilator data (ie, the patient's respiratory rate begins to increase) that the patient is awakening from anesthesia.

Finally, the fourteenth step 5228 is for the healthcare professional to remove various patient monitoring devices from the patient. Therefore, surgical hubs 106, 206 can presume that the patient is being transferred to the recovery room when the hub loses other data from the EKG, BP, and patient monitoring device. As can be seen from the description of this exemplary procedure, the surgical hubs 106, 206 are given a given surgical procedure, based on data received from various data sources communicatively coupled with the surgical hubs 106, 206. It is possible to determine or estimate when each step of is occurring.

Situational awareness is further described in US Patent Provisional Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. .. In certain examples, the operation of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, is based on its situational awareness and / or feedback from its components, and / or from the cloud 102. Can be controlled by hubs 106, 206 based on the information in.

Although several forms have been exemplified and described, it is not the applicant's intent to limit or limit the accompanying "claims" to such details. A number of modifications, modifications, changes, substitutions, combinations and equivalents of these forms can be implemented and will be conceived by those skilled in the art without departing from the scope of the present disclosure. Further, the structure of each element associated with the form described can be described alternative as a means for providing the functionality performed by that element. Also, although the material is disclosed for a particular component, other materials may be used. Therefore, the above description and the appended claims are intended to cover all such modifications, combinations, and modifications as included within the scope of the disclosed form. I want you to understand. The appended claims are intended to cover all such modifications, modifications, changes, substitutions, modifications, and equivalents.

The above detailed description has described various forms of equipment and / or processes using block diagrams, flowcharts, and / or examples. As long as such block diagrams, flowcharts, and / or embodiments include one or more functions and / or operations, it is appreciated by those skilled in the art that such block diagrams, flowcharts, and / or Each function and / or operation included in the embodiments can be implemented individually and / or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. To those skilled in the art, all or part of some of the embodiments disclosed herein may be as one or more computer programs running on one or more computers (eg, 1). As one or more programs running on one or more computer systems (as one or more programs running on one or more computer systems) (eg, as one or more programs running on one or more processors) Can be equivalently implemented on an integrated circuit as one or more programs running on a microprocessor, as firmware, or as virtually any combination thereof, and designing the circuit. And / or writing code for software and / or firmware will be understood to be within the skill of those skilled in the art in light of the present disclosure. Further, as will be appreciated by those skilled in the art, the mechanisms of subject matter described herein can be distributed in a variety of forms as one or more program products, which are described herein. The specific forms of the described subject matter are used regardless of the particular type of signal carrier used in the actual distribution.

Instructions used to program logic to perform various disclosed aspects can be stored in in-system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. In addition, instructions can be distributed over the network or by other computer-readable media. Therefore, the machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (for example, a computer), such as a floppy diskette, an optical disk, a compact disk, or a read-only memory (CD). -ROM), as well as magnetic optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, Tangible machine readable used to transmit information over the Internet via flash memory or electrical, optical, acoustic, or other forms of propagating signals (eg, carriers, infrared signals, digital signals, etc.) Not limited to storage. Thus, non-transitory computer-readable media include any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect of the specification, the term "control circuit" refers to, for example, a hard-wired circuit, a programmable circuit (eg, a computer processor containing one or more individual instruction processing cores, processing). Unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic mechanism (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state mechanical circuit, programmable circuit It can refer to a firmware that stores the instructions executed by, and any combination thereof. Control circuits can be collectively or individually, for example, integrated circuits (ICs), application-specific integrated circuits (ASICs), system-on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. , Can be embodied as a circuit that forms part of a larger system. Therefore, as used herein, the "control circuit" is an electric circuit having at least one individual electric circuit, an electric circuit having at least one integrated circuit, and an electric circuit having at least one integrated circuit for a specific application. A circuit, a general-purpose computing device composed of a computer program (for example, a general-purpose computer composed of a computer program that executes at least a part of the process and / or the device described in the present specification, or a process described in the present specification. And / or electrical circuits that form a computer program that at least partially executes the device, electrical circuits that form a memory device (eg, in the form of a random access memory), and / or a communication device (eg, a communication device). Examples include, but are not limited to, electrical circuits that form modems, communication switches, or optical-electrical equipment. Those skilled in the art will recognize that the subjects described herein may be realized in analog or digital forms or some combination thereof.

As used in any aspect of the specification, the term "logic" may refer to an application, software, firmware, and / or circuit configured to perform any of the aforementioned operations. The software may be embodied as software packages, codes, instructions, instruction sets, and / or data recorded on non-temporary computer-readable storage media. Firmware may be embodied as code, instructions, or instruction sets in a memory device, and / or as hard-coded (eg, non-volatile) data.

As used in any aspect of the specification, terms such as "component", "system", "module" are either hardware, a combination of hardware and software, software, or running software. Can refer to a computer-related entity that is.

As used in any aspect of the specification, an "algorithm" refers to a self-consistent sequence of steps that leads to a desired result, and a "step" is, but is not necessarily necessary, a memory, transfer, combination, Refers to the manipulation of physical quantities and / or logical states that can be in the form of electrical or magnetic signals that can be compared and manipulated differently. It is common practice to refer to these signals as bits, values, elements, symbols, letters, terms, numbers, and so on. These and similar terms may be associated with appropriate physical quantities and are simply convenient labels that apply to these quantities and / or conditions.

The network may include a packet switching network. Communication devices can communicate with each other using selected packet-switched network communication protocols. One exemplary communication protocol includes an Ethernet communication protocol that can enable communication using a transmission control protocol / Internet Protocol (TCP / IP). The Ethernet protocol conforms to or is compatible with the December 2008 title "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE), and / or later versions of the Ethernet standard. There can be sex. Alternatively or additionally, the communication device is X.I. Twenty-five communication protocols can be used to communicate with each other. X. The 25 communication protocols may conform to or be compatible with the standards promulgated by the International Telecommunication Union-Telecommunication Standardization Detector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using the Frame Relay communication protocol. The Frame Relay communication protocol conforms to or is compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transmitters and receivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol conforms to or is compatible with the ATM standard published in August 2001 by the ATM Forum under the title "ATM-MPLS Network Interworking 2.0" and / or later versions of this standard. obtain. Not surprisingly, connection-oriented network communication protocols developed differently and / or later are equally contemplated herein.

Unless otherwise stated, as is clear from the above disclosure, throughout the above disclosure, "process," "calculate," "calculate," "determine," "display," etc. Discussions that use the term refer to data expressed as a physical (electronic) quantity in a computer system's memory or memory as a physical quantity in the computer system's memory or register or such information storage, transmission, or display device. It will be appreciated that it refers to the operation and processing of a computer system or similar electronic computing device that manipulates and transforms into other similarly represented data.

One or more components are "configured to", "configurable to", and "operable / as" herein. "Operaable / operative to", "adapted / adaptive", "able to", "conformable / conformable" to) ”and so on. Those skilled in the art will generally appreciate that "configured as" is an active component and / or an inactive component and / or a standby component, unless the context should be interpreted in other ways. You will understand that it can contain elements.

The terms "proximal" and "distal" are used herein with reference to the clinician operating the handle portion of the surgical instrument. The term "proximal" refers to the part closest to the clinician, and the term "distal" refers to the part located away from the clinician. For convenience and clarity, it will be further understood that spatial terms such as "vertical", "horizontal", "top", and "bottom" can be used with respect to the drawings herein. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limited and / or absolute.

Those skilled in the art generally intend that the terms used herein, and in particular in the appended claims (eg, the text of the appended claims), are generally "open" terms. The term "including" should be interpreted as "including but not limited to" and the term "having". Should be interpreted as "having at least" and the term "includes" should be interpreted as "includes but is not limited to" You will understand that it should be done, etc.). In addition, if a particular number is intended in the introduced claim recitation, such intent is clearly stated in the claim, and in the absence of such intent, such intent does not exist. However, those skilled in the art will understand. For example, as an aid to understanding, the following claims include the introductory phrases "at least one" and "one or more". May be included to introduce the description. However, the use of such a phrase is "one or more" or "at least one" within the same claim, even if the claim description is introduced by the indefinite definite "a" or "an". Any particular claim, including such an introduced claim statement, even if it contains an introductory phrase such as "a" or an indefinite article "a" or "an", is a claim that includes only one such statement. It should not be construed as suggested to be limited (eg, "a" and / or "an" usually means "at least one" or "one or more". Should be interpreted). The same is true when introducing claims using definite articles.

Moreover, even if a particular number is specified in the introduced claims, such statement should typically be construed to mean at least the number stated. , Will be recognized by those skilled in the art (eg, if there is a mere "two entries" with no other modifiers, then generally at least two entries, or two or more statements. Means matter). Further, when a notation similar to "at least one of A, B, C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art will understand the notation (eg, for example. , "A system having at least one of A, B, and C", but is not limited to, A only, B only, C only, both A and B, both A and C, B and Includes systems with both C and / or all of A, B and C, etc.). When a notation similar to "at least one of A, B, C, etc." is used, such syntax is generally intended to mean that one of ordinary skill in the art will understand the notation (eg, "" A system having at least one of A, B, or C "is, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C. Includes systems with both and / or all of A, B and C, etc.). Moreover, typically any selective word and / or phrase representing two or more selective terms is used in the specification unless the context requires other meanings. It is understood that it is intended to include one of those terms, any of those terms, or both, whether in the claims, in the claims, or in the drawings. Those skilled in the art will understand that it should be. For example, the phrase "A or B" will typically be understood to include the possibility of "A" or "B" or "A and B".

With respect to the appended claims, one of ordinary skill in the art will appreciate that the actions cited herein can generally be performed in any order. In addition, although the flow charts of various operations are shown in a sequence (s), it is understood that the various operations may be performed in an order other than those illustrated, or may be performed at the same time. It should be. Examples of such alternative ordering are duplicates, alternations, interrupts, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different ordering, unless the context requires other meanings. May include. In addition, terms such as "responding to", "related to", or other past tense adjectives may generally exclude such variants unless they should be interpreted in other ways in the context. Not intended.

Any reference to "one aspect", "aspect", "exemplification", "one example", etc. includes a particular mechanism, structure, or property described in connection with that aspect in at least one aspect. It is worth noting that it means. Thus, the terms "in one aspect", "in an embodiment", "in an example", and "in an example" found in various places throughout the specification do not necessarily all refer to the same aspect. Moreover, certain features, structures, or properties can be combined in any suitable manner in one or more embodiments.

Any patent application, patent, non-patent publication, or other disclosed material referenced herein and / or listed in any application datasheet is to the extent that the material incorporated is consistent with this specification. , Incorporated herein by reference. As such, and to the extent necessary, the disclosures expressly set forth herein shall supersede any contradictory statements incorporated herein by reference. Any content that conflicts with current definitions, views, or other disclosures described herein, or parts thereof, shall be incorporated herein by reference, but with reference and current disclosure. It shall be referred to only to the extent that there is no contradiction with.

In summary, many benefits have been described as a result of using the concepts described herein. The above description in one or more forms is presented for purposes of illustration and explanation. It is not intended to be inclusive or limited to the exact form disclosed. In view of the above teachings, modifications or modifications are possible. One or more forms exemplify the principles and practical applications, thereby making various forms available to those skilled in the art as suitable for the particular application conceived, along with various modifications. Therefore, it has been selected and described. The claims presented with this specification are intended to define the overall scope.

Various aspects of the subject matter described herein are described in the numbered examples below.

Example 1. A method of locating tissue located within an end effector of an ultrasonic surgical instrument equipped with an ultrasonic converter, wherein the end effector comprises an ultrasonic blade acoustically coupled to the ultrasonic converter. Method. The method is to apply the first power level to the ultrasonic converter by the control circuit, and to measure the first impedance measurement value of the ultrasonic converter corresponding to the first power level by the control circuit. The control circuit applies a second power level to the ultrasonic converter, and the control circuit measures the second impedance measurement value of the ultrasonic converter corresponding to the second power level. The control circuit calculates the difference in the impedance of the ultrasonic converter between the first impedance measurement value and the second impedance measurement value, and the control circuit calculates the difference in the impedance of the ultrasonic converter. It includes comparing with a threshold and determining the position of the tissue positioned within the end effector based on the first threshold by the control circuit.

Example 2. The method of Example 1, wherein the first power level is less than the second power level.

Example 3. The method according to Example 1 or 2, wherein the first and second power levels are below the therapeutic power level and the therapeutic power level is sufficient to cause the ultrasonic blade to coagulate and transectate the tissue.

Example 4. The method according to any one of Examples 1 to 3, wherein the first power level is 0.2 amperes.

Example 5. The method according to any one of Examples 1 to 4, wherein the second power level is twice the first power level.

Example 6. The method according to any one of Examples 1 to 5, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm.

Example 7. The control circuit further includes applying a therapeutic power level to the ultrasonic transducer based on the location of the tissue within the end effector, the therapeutic power level being sufficient for the ultrasonic blade to coagulate and transversely incis the tissue. The method according to any one of Examples 1 to 6, wherein the power level is high.

Example 8. The control circuit compares the difference in ultrasonic converter impedance with the second threshold, and the control circuit determines whether the tissue located within the end effector is in the proximal, intermediate, or distal position. The method according to any one of Examples 1 to 7, further comprising determining according to the difference in ultrasonic converter impedance with respect to the first threshold value and the second threshold value.

Example 9. An ultrasonic surgical instrument that can be connected to a generator. The ultrasonic surgical instrument includes an end effector including an ultrasonic blade, an ultrasonic converter acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic converter. The ultrasonic converter is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from the generator. The control circuit applies various power levels to the ultrasonic converter via the ultrasonic generator, measures the impedance of the ultrasonic converter corresponding to the various power levels, and between the impedances of the ultrasonic converter with respect to the threshold. It is configured to determine the position of the tissue located within the end effector according to the difference between the two.

Example 10. The ultrasonic surgical instrument according to Example 9, wherein the control circuit is configured to vary the power level applied to the ultrasonic transducer between a first power level and a second power level. ..

Example 11. 10. Example 10, wherein the first and second power levels are below the therapeutic power level and the therapeutic power level is sufficient to cause the ultrasonic blade to coagulate and transversely incise the tissue. Ultrasonic surgical instruments.

Example 12. The ultrasonic surgical instrument according to Example 10 or 11, wherein the first power level is 0.2 amperes.

Example 13. The ultrasonic surgical instrument according to any one of Examples 10 to 12, wherein the second power level is twice the first power level.

Example 14. The ultrasonic surgical instrument according to any one of Examples 10 to 13, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm.

Example 15. A control circuit is further configured to apply a therapeutic power level to the ultrasonic converter based on the location of the tissue within the end effector, and the therapeutic power level causes the ultrasonic blade to coagulate and traverse the tissue. The ultrasonic surgical instrument according to any one of Examples 9 to 14, which has a sufficient power level.

Example 16. The ultrasonic surgical instrument according to any one of Examples 9 to 15, wherein the threshold value includes a first threshold value. The control circuit compares the difference between the impedances of the ultrasonic converter with the second threshold and determines whether the tissue located within the end effector is in the proximal, intermediate, or distal position. It is further configured to perform determination according to the difference between the impedances of the ultrasonic converters with respect to the first threshold value and the second threshold value.

Example 17. An ultrasonic generator that can be connected to an ultrasonic instrument including an end effector, an ultrasonic blade, and an ultrasonic converter acoustically coupled to the ultrasonic blade. The ultrasonic generator includes a control circuit that can be coupled to the ultrasonic converter. The control circuit applies different power levels to the ultrasonic transducer, measures the impedance of the ultrasonic transducer for different power levels, and follows the difference between the ultrasonic transducer's impedance to the threshold. , To determine the location of the tissue located within the end effector, and to do.

Example 18. The ultrasonic generator according to Example 17, wherein the control circuit is configured to vary the power level applied to the ultrasonic converter between a first power level and a second power level.

Example 19. The super-power level according to Example 18, wherein the first power level and the second power level are below the therapeutic power level, and the therapeutic power level is a power level sufficient for the ultrasonic blade to coagulate and cross-incision the tissue. Sound generator.

Example 20. The ultrasonic generator according to Example 18 or 19, wherein the first power level is 0.2 amperes.

Example 21. The ultrasonic generator according to any one of Examples 18 to 20, wherein the second power level is twice the first power level.

Example 22. The ultrasonic generator according to any one of Examples 18 to 21, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm.

Example 23. A control circuit is further configured to apply a therapeutic power level to the ultrasonic converter based on the location of the tissue within the end effector, and the therapeutic power level causes the ultrasonic blade to coagulate and traverse the tissue. The ultrasonic generator according to any one of Examples 17 to 22, which has a sufficient power level.

Example 24. The ultrasonic generator according to any one of Examples 17 to 23, wherein the threshold value includes a first threshold value. The control circuit compares the difference between the impedances of the ultrasonic converter with the second threshold and determines whether the tissue located within the end effector is in the proximal, intermediate, or distal position. It is further configured to perform determination according to the difference between the impedances of the ultrasonic converters with respect to the first threshold value and the second threshold value.

[Implementation mode]
(1) A method of determining the position of a tissue located in an end effector of an ultrasonic surgical instrument including an ultrasonic converter, wherein the end effector is acoustically coupled to the ultrasonic converter. The above method is equipped with a sonic blade.
Applying a first power level to the ultrasonic transducer by a control circuit
Using the control circuit to measure the first impedance measurement value of the ultrasonic converter corresponding to the first power level,
Applying a second power level to the ultrasonic transducer by the control circuit
Using the control circuit to measure the second impedance measurement value of the ultrasonic converter corresponding to the second power level,
Using the control circuit, the difference in ultrasonic transducer impedance between the first impedance measurement value and the second impedance measurement value can be calculated.
By the control circuit, the difference in the ultrasonic converter impedance is compared with the first threshold value, and
A method comprising: determining the position of the tissue positioned within the end effector by the control circuit based on the first threshold.
(2) The method according to embodiment 1, wherein the first power level is less than the second power level.
(3) The first and second power levels are below the therapeutic power level, and the therapeutic power level is a power level sufficient for the ultrasonic blade to coagulate and transversely incis the tissue. The method described in.
(4) The method according to embodiment 1, wherein the first power level is 0.2 amperes.
(5) The method according to embodiment 1, wherein the second power level is twice the first power level.

(6) The method according to the first embodiment, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm.
(7) The control circuit further comprises applying a therapeutic power level to the ultrasonic transducer based on the position of the tissue in the end effector, the therapeutic power level being applied to the ultrasonic blade. The method of embodiment 1, wherein the power level is sufficient to coagulate and transversely incis the tissue.
(8) By the control circuit, the difference in the impedance of the ultrasonic converter is compared with the second threshold value, and
The ultrasonic transducer impedance with respect to the first threshold and the second threshold indicates whether the tissue positioned in the end effector is in the proximal position, the intermediate position, or the distal position by the control circuit. The method according to the first embodiment, further comprising determining according to the difference between the above.
(9) An ultrasonic surgical instrument that can be connected to a generator.
With an end effector equipped with an ultrasonic blade,
An ultrasonic converter acoustically coupled to the ultrasonic blade, which is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from the generator. When,
A control circuit coupled to the ultrasonic converter is provided, and the control circuit comprises a control circuit.
Applying various power levels to the ultrasonic transducer through the ultrasonic generator,
Measuring the impedance of the ultrasonic transducer corresponding to the various power levels and
An ultrasonic surgical instrument configured to determine the position of tissue located within the end effector according to the difference between the impedances of the ultrasonic transducer with respect to a threshold.
(10) The ninth embodiment, wherein the control circuit is configured to change the power level applied to the ultrasonic converter between a first power level and a second power level. Ultrasound surgical instruments.

(11) The first power level and the second power level are below the therapeutic power level, which is a power level sufficient for the ultrasonic blade to coagulate and transversely incis the tissue. , The ultrasonic surgical instrument according to the tenth embodiment.
(12) The ultrasonic surgical instrument according to embodiment 10, wherein the first power level is 0.2 amperes.
(13) The ultrasonic surgical instrument according to embodiment 10, wherein the second power level is twice the first power level.
(14) The ultrasonic surgical instrument according to embodiment 10, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm.
(15) The control circuit is further configured to apply a therapeutic power level to the ultrasonic converter based on the position of the tissue in the end effector, the therapeutic power level being the ultrasonic blade. The ultrasonic surgical instrument according to embodiment 9, wherein the power level is sufficient to coagulate and transversely incise the tissue.

(16) The threshold value includes the first threshold value, and the control circuit
Comparing the difference between the impedances of the ultrasonic transducer with the second threshold,
Whether the tissue located in the end effector is in the proximal, intermediate, or distal position between the impedance of the ultrasonic converter with respect to the first and second thresholds. The ultrasonic surgical instrument according to embodiment 9, further configured to perform and to determine according to the difference.
(17) An ultrasonic generator that can be connected to an ultrasonic instrument including an end effector, an ultrasonic blade, and an ultrasonic converter acoustically coupled to the ultrasonic blade, and generates the ultrasonic wave. The vessel
A control circuit that can be coupled to the ultrasonic converter is provided, and the control circuit is
Applying various power levels to the ultrasonic transducer and
Measuring the impedance of the ultrasonic transducer corresponding to the various power levels and
An ultrasonic generator configured to determine the position of tissue positioned within the end effector according to the difference between the impedances of the ultrasonic converter with respect to a threshold.
(18) The 17th embodiment, wherein the control circuit is configured to change the power level applied to the ultrasonic converter between a first power level and a second power level. Ultrasonic generator.
(19) The first power level and the second power level are below the therapeutic power level, at a power level sufficient for the ultrasonic blade to coagulate and and transversely incis the tissue. The ultrasonic generator according to embodiment 18.
(20) The ultrasonic generator according to embodiment 18, wherein the first power level is 0.2 amperes.

(21) The ultrasonic generator according to embodiment 18, wherein the second power level is twice the first power level.
(22) The ultrasonic generator according to embodiment 18, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm.
(23) The control circuit is further configured to apply a therapeutic power level to the ultrasonic converter based on the position of the tissue in the end effector, the therapeutic power level being the ultrasonic blade. The ultrasonic generator according to embodiment 17, wherein the power level is sufficient to coagulate and transversely incis the tissue.
(24) The threshold value includes the first threshold value, and the control circuit
Comparing the difference between the impedances of the ultrasonic transducer with the second threshold,
Whether the tissue located in the end effector is in the proximal, intermediate, or distal position between the impedance of the ultrasonic converter with respect to the first and second thresholds. The ultrasonic generator according to embodiment 17, further configured to perform determination according to the difference.

Claims (24)

A method of determining the position of tissue located within an end effector of an ultrasonic surgical instrument equipped with an ultrasonic converter, wherein the end effector is an ultrasonic blade acoustically coupled to the ultrasonic converter. In preparation, the above method
Applying a first power level to the ultrasonic transducer by a control circuit
Using the control circuit to measure the first impedance measurement value of the ultrasonic converter corresponding to the first power level,
Applying a second power level to the ultrasonic transducer by the control circuit
Using the control circuit to measure the second impedance measurement value of the ultrasonic converter corresponding to the second power level,
Using the control circuit, the difference in ultrasonic transducer impedance between the first impedance measurement value and the second impedance measurement value can be calculated.
By the control circuit, the difference in the ultrasonic converter impedance is compared with the first threshold value, and
A method comprising: determining the position of the tissue positioned within the end effector by the control circuit based on the first threshold. The method of claim 1, wherein the first power level is less than the second power level. The first and second power levels are below the therapeutic power level, and the therapeutic power level is a power level sufficient for the ultrasonic blade to coagulate and transversely incis the tissue. Method. The method of claim 1, wherein the first power level is 0.2 amperes. The method of claim 1, wherein the second power level is twice the first power level. The method of claim 1, wherein the first power level and the second power level cause the ultrasonic transducer to vibrate the ultrasonic blade with an amplitude of less than 35 μm. The control circuit further comprises applying a therapeutic power level to the ultrasonic transducer based on the position of the tissue in the end effector, the therapeutic power level causing the tissue to be applied to the ultrasonic blade. The method of claim 1, wherein the power level is sufficient for coagulation and transverse incision. By the control circuit, the difference in the ultrasonic converter impedance is compared with the second threshold value, and
The ultrasonic transducer impedance with respect to the first threshold and the second threshold indicates whether the tissue positioned in the end effector is in the proximal position, the intermediate position, or the distal position by the control circuit. The method according to claim 1, further comprising determining according to the difference between the two. An ultrasonic surgical instrument that can be connected to a generator
With an end effector equipped with an ultrasonic blade,
An ultrasonic converter acoustically coupled to the ultrasonic blade, which is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from the generator. When,
A control circuit coupled to the ultrasonic converter is provided, and the control circuit comprises a control circuit.
Applying various power levels to the ultrasonic transducer through the ultrasonic generator,
Measuring the impedance of the ultrasonic transducer corresponding to the various power levels and
An ultrasonic surgical instrument configured to determine the position of tissue located within the end effector according to the difference between the impedances of the ultrasonic transducer with respect to a threshold. The ultrasonic wave according to claim 9, wherein the control circuit is configured to change the power level applied to the ultrasonic converter between a first power level and a second power level. Surgical instruments. The first power level and the second power level are below the therapeutic power level, and the therapeutic power level is a power level sufficient for the ultrasonic blade to coagulate and transversely incis the tissue. 10. The ultrasonic surgical instrument according to 10. The ultrasonic surgical instrument according to claim 10, wherein the first power level is 0.2 amperes. The ultrasonic surgical instrument according to claim 10, wherein the second power level is twice the first power level. The ultrasonic surgical instrument according to claim 10, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm. The control circuit is further configured to apply a therapeutic power level to the ultrasonic transducer based on the position of the tissue in the end effector, and the therapeutic power level is applied to the ultrasonic blade to the tissue. The ultrasonic surgical instrument according to claim 9, wherein the power level is sufficient to coagulate and make a transverse incision. The threshold includes a first threshold, and the control circuit
Comparing the difference between the impedances of the ultrasonic transducer with the second threshold,
Whether the tissue located in the end effector is in the proximal, intermediate, or distal position between the impedance of the ultrasonic converter with respect to the first and second thresholds. The ultrasonic surgical instrument according to claim 9, further configured to perform and to determine according to the difference. An ultrasonic generator capable of being connected to an ultrasonic instrument including an end effector, an ultrasonic blade, and an ultrasonic converter acoustically coupled to the ultrasonic blade.
A control circuit that can be coupled to the ultrasonic converter is provided, and the control circuit is
Applying various power levels to the ultrasonic transducer and
Measuring the impedance of the ultrasonic transducer corresponding to the various power levels and
An ultrasonic generator configured to determine the position of tissue positioned within the end effector according to the difference between the impedances of the ultrasonic converter with respect to a threshold. 17. The ultrasonic wave according to claim 17, wherein the control circuit is configured to change the power level applied to the ultrasonic converter between a first power level and a second power level. Generator. Claimed that the first power level and the second power level are below the therapeutic power level and the therapeutic power level is sufficient to cause the ultrasonic blade to coagulate and and transversely incis the tissue. Item 18. The ultrasonic generator according to Item 18. The ultrasonic generator according to claim 18, wherein the first power level is 0.2 amperes. The ultrasonic generator according to claim 18, wherein the second power level is twice the first power level. The ultrasonic generator according to claim 18, wherein the first power level and the second power level cause the ultrasonic converter to vibrate the ultrasonic blade with an amplitude of less than 35 μm. The control circuit is further configured to apply a therapeutic power level to the ultrasonic transducer based on the position of the tissue in the end effector, and the therapeutic power level is applied to the ultrasonic blade to the tissue. The ultrasonic generator according to claim 17, wherein the power level is sufficient to coagulate and make a transverse incision. The threshold includes a first threshold, and the control circuit
Comparing the difference between the impedances of the ultrasonic transducer with the second threshold,
Whether the tissue located in the end effector is in the proximal, intermediate, or distal position between the impedance of the ultrasonic converter with respect to the first and second thresholds. The ultrasonic generator according to claim 17, further configured to perform determination according to the difference.

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