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US20200281561A1 - Systems, Methods, and Devices for Instrument Guidance - Google Patents

Systems, Methods, and Devices for Instrument Guidance Download PDF

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Publication number
US20200281561A1
US20200281561A1 US16/810,569 US202016810569A US2020281561A1 US 20200281561 A1 US20200281561 A1 US 20200281561A1 US 202016810569 A US202016810569 A US 202016810569A US 2020281561 A1 US2020281561 A1 US 2020281561A1
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US
United States
Prior art keywords
instrument
instrument guide
guide
ultrasound probe
bracket
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US16/810,569
Inventor
Lucas Muller
Cassidy Wang
Dev Mandavia
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethos Medical Inc
Original Assignee
Ethos Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethos Medical Inc filed Critical Ethos Medical Inc
Priority to US16/810,569 priority Critical patent/US20200281561A1/en
Priority to US16/816,363 priority patent/US11701088B2/en
Assigned to Ethos Medical, Inc. reassignment Ethos Medical, Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MANDAVIA, DEV, MULLER, LUCAS, WANG, CASSIDY
Priority to AU2020304669A priority patent/AU2020304669A1/en
Priority to JP2021576834A priority patent/JP2022538126A/en
Priority to EP20832232.1A priority patent/EP3989850A4/en
Priority to CA3139694A priority patent/CA3139694A1/en
Priority to PCT/US2020/039938 priority patent/WO2020264383A1/en
Publication of US20200281561A1 publication Critical patent/US20200281561A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4209Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4245Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
    • A61B8/4254Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient using sensors mounted on the probe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461Displaying means of special interest
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461Displaying means of special interest
    • A61B8/463Displaying means of special interest characterised by displaying multiple images or images and diagnostic data on one display
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5207Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of raw data to produce diagnostic data, e.g. for generating an image
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00221Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • A61B2017/3405Needle locating or guiding means using mechanical guide means
    • A61B2017/3407Needle locating or guiding means using mechanical guide means including a base for support on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • A61B2017/3413Needle locating or guiding means guided by ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/107Visualisation of planned trajectories or target regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2063Acoustic tracking systems, e.g. using ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0223Magnetic field sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4209Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4227Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by straps, belts, cuffs or braces

Definitions

  • the present invention relates generally to systems, methods, and devices for instrument guidance and, more particularly, to systems, methods, and devices for guiding the placement of instruments within the body using ultrasound imaging.
  • Ultrasound imaging can provide real-time two-dimensional imaging of a patient's body, which can be used to assist a healthcare professional to locate a region to insert an invasive medical device (e.g., a needle or a cylindrical instrument such a trocar, etc.). Once the healthcare professional locates the correct insertion point, the healthcare professional may then begin the medical procedure, such as insertion of a catheter, administration of a local anesthetic, or removal of tissue as in a biopsy. Determining at what orientation to insert the invasive medical device to ensure an unobstructed path to the target is challenging, as the ultrasound monitor can only display structures within the patient's body. It can also be difficult to tell what path the medical device will follow before the device enters the patient's body.
  • an invasive medical device e.g., a needle or a cylindrical instrument such a trocar, etc.
  • the medical device after the medical device enters the patient's body, it can be difficult to accurately track the path and position of the medical device on the ultrasound monitor.
  • the needle unless the needle is positioned exactly in-plane with the image, the needle may not be visible or may only be partially visible, which means that the needle location or, more importantly, the location of the needle tip is not precisely known.
  • the healthcare professional may make numerous attempts to insert the device before properly entering a tissue mass or penetrating a blood vessel.
  • the healthcare professional can often only estimate the location of the needle end if it is not visible on the ultrasound image. As a result, patients may be injured or made to suffer unnecessary pain. From the healthcare professional's perspective, these procedures can be time consuming, and can expose the healthcare professional to liability.
  • an exemplary device can include an instrument guide device and a transducer system.
  • the instrument guide device can comprise an instrument guide, an instrument guide insert, and an instrument guide bracket.
  • the instrument guide can include a first aperture, a magnet, and one or more protrusions.
  • the instrument guide can be configured to secure at least one instrument. Further, the instrument guide can be adaptable to secure instruments of different sizes.
  • the instrument guide bracket can be removably attachable to the instrument guide when at least a first protrusion of the instrument guide engages with at least a first opening of the instrument guide bracket.
  • the transducer system can comprise an ultrasound probe bracket and an ultrasound probe.
  • the ultrasound probe bracket can include a first sensor, a transceiver, and a processor.
  • the first sensor can be configured to determine a position of the instrument guide device by wirelessly tracking the magnet located in the instrument guide. That is, as the instrument guide is moved around a body, the first sensor tracks the magnet to determine the position of the instrument guide device.
  • the ultrasound probe bracket further includes a transceiver that is configured to receive the position of the instrument guide device from the first sensor, and then output the position to an external device (e.g., a computing device).
  • the ultrasound probe bracket can further include a cutout sized to allow the instrument guide device to fit within and a member (e.g., snap features, protrusions, cutouts, and/or spring-loaded inserts) that allows the instrument guide device to removably attach to the ultrasound probe bracket.
  • the ultrasound probe bracket can include a single or pair of protruding features that provide attachment to the instrument guide bracket.
  • the ultrasound probe bracket can be sized to fit around the ultrasound probe and can be removably attachable to the ultrasound probe.
  • the ultrasound probe can generate and send image information to the processor. Then, the processor can generate position data using the position of the instrument guide device and/or the image information.
  • the instrument guide can include a plurality of instrument guide inserts having different instrument sizes and/or gauges.
  • the instrument guide can include a single insert that can be rotated to different positions to create different apertures sized to accommodate different instrument sizes and/or gauges.
  • the instrument guide insert can be sized to fit within the first aperture, wherein the at least one instrument is secured to the instrument guide insert.
  • a first insert can be positioned into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket. Also, the first insert can be further positioned into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis and that the first insert induces friction that causes the instrument guide to maintain its orientation.
  • the ultrasound probe bracket is adaptable to fit a plurality of geometries.
  • the instrument guide in response to movement of the instrument guidance system, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
  • a first instrument is removably attachable to the instrument guide when the first instrument is inserted within a second aperture perpendicular to the instrument guide's axis of rotation.
  • the instrument guide includes a rotation lock configured to allow and prevent rotation of the instrument guide.
  • the processor of the ultrasound probe bracket can determine whether the instrument guide is attached to the instrument guidance system. Also, the ultrasound probe bracket can include a second sensor configured to provide power and disengage power to the instrument guidance device when the instrument guide is attached or detached, respectively. It should be noted that the first sensor can perform all or some of the functions of the second sensor and vice versa.
  • An exemplary method includes a computing device receiving imaging data from an ultrasound device, which the computing device can display.
  • the computing device can also communicate with an instrument guide device to receive position data that indicates an angle of an instrument attached to the instrument guide device.
  • the computing device is preprogrammed with: 1) the physical location of the instrument guide device's axis of rotation relative to the imaging surface of the ultrasound transducer; and 2) an algorithm to compute the pixel distance on the display corresponding to a physical metric in the ultrasound image (e.g., centimeters) at any given imaging depth. Then, the computing device can determine where the trajectory of the instrument should lie on the ultrasound image in real-time.
  • the generated image can then be displayed on a screen of the computing device, for example, as a graphical user interface (GUI).
  • GUI graphical user interface
  • the ultrasound device can receive the position data from the instrument guide device and can generate the image overlay in a manner similar or identical to that disclosed above in reference to the computing device.
  • the first sensor can be included in the instrument guide device rather than in the ultrasound probe bracket.
  • the ultrasound probe cover can include sealed, electrical ports, or contacts to enable electrical connection between the first sensor in the instrument guide device and the processor and/or transceiver in the ultrasound probe bracket, while maintaining a sterile barrier.
  • the instrument guide device can be permanently coupled to the ultrasound probe cover, through methods such as adhesive or thermal bonding, such that attachment of the ultrasound probe cover and instrument guide device over/onto the ultrasound probe bracket can occur simultaneously.
  • FIG. 1 is an example system for instrument guidance, in accordance with some examples of the present disclosure
  • FIG. 2A is an isometric view of an instrument guidance device, in accordance with some examples of the present disclosure.
  • FIG. 2B is a top view of an instrument guidance device, in accordance with some examples of the present disclosure.
  • FIG. 2C is a top view of an instrument guide device, in accordance with some examples of the present disclosure.
  • FIG. 3A is an isometric view of an ultrasound probe bracket and an attached instrument guide device, in accordance with some examples of the present disclosure
  • FIG. 3B is an exploded view of an ultrasound probe bracket, in accordance with some examples of the present disclosure.
  • FIG. 4 is an example timing diagram for instrument guidance, in accordance with some examples of the present disclosure.
  • FIG. 5 is an example flow chart of a method for instrument guidance, in accordance with some examples of the present disclosure.
  • FIG. 1 is a schematic of an exemplary system 100 used for instrument guidance.
  • the system 100 includes a computing device 110 , an instrument guidance device 120 , and an ultrasound device 130 .
  • the instrument guide device 125 can include a first aperture, a magnet, and one or more protrusions.
  • the instrument guide device 125 can include a sensing element (e.g., a potentiometer, a feature to engage with a potentiometer, an optical sensing element that can be used by an optical sensor, and/or a capacitive sensing element that can be used by a capacitive sensor).
  • the sensing element can be contained in an instrument guide insert that is attached to the instrument guide device 125 .
  • the computing device 110 can include one or more processors 112 , transceiver 114 , and display 116 , among other things.
  • the computing device 110 can communicate with the instrument guidance device 120 and/or the ultrasound device 130 .
  • the ultrasound device 130 can emit high-frequency sound waves that, when a transducer of the ultrasound device 130 is placed against a body, reflect off body structures. The ultrasound device 130 can then receive the waves and can use the waves to create imaging data. Here, the ultrasound device 130 can send the imaging data in real-time to the computing device 110 .
  • the instrument guidance device 120 can include ultrasound probe 121 , ultrasound probe bracket 122 , instrument guide device 125 , first sensor 123 A, second sensor 123 B, ultrasound transceiver 124 A, and ultrasound processor 124 B.
  • the ultrasound transceiver 124 A can be located in ultrasound probe bracket 122 and can transmit various data including position data and a unique identifier for the ultrasound probe 121 .
  • the first sensor 123 A and/or second sensor 123 B can be a magnetoresistive sensor, Hall effect sensor, magnetic potentiometer, and/or the like that can be configured to detect a magnetic field and changes as the magnetic field is rotated and/or translated.
  • a user e.g., a physician
  • the instrument guide device 125 of the instrument guidance device 120 can hold one or more instruments of differing sizes, which can be attributed to a multi-faceted block which can rotate beside an open channel to create a closed channel of variable size (shown in FIG. 2C ).
  • the instrument guide device 125 can include a plurality of disposable instrument inserts that are each designed to fit a specific instrument guide, but each has a consistent outer geometry to attach.
  • the instrument guide device 125 can include a single instrument insert that includes a plurality of faces or a single continuous face that when the instrument insert is twisted, changes the size of a second aperture created between the instrument insert and the instrument guide device 125 , which can allow for different instrument sizes and/or gauges to be used.
  • the instrument guide device 125 can be a single disposable instrument guide that accepts a plurality of instrument sizes. An instrument inserted into the instrument guide device 125 can be indirectly and/or removably attached or attachable to the ultrasound probe 121 .
  • the magnet can change orientation accordingly; however, the magnet can be in a fixed position in rotating element of the instrument guidance device 120 , such that the magnet does not change the angle and/or position relative to the rotating element.
  • the first sensor 123 A can wirelessly track the magnet, using for example magnetoresistive properties that rely on the magnetic field, to determine an orientation (e.g., angle) and/or position of the instrument guide device 125 .
  • the ultrasound processor 124 B can generate position data (e.g., angle and positioning values), which can be in relation to the surface of the ultrasound probe 121 .
  • the first sensor 123 A can send a voltage within a range (e.g., 0-3.3 volts) corresponding to the angle of the magnet to the ultrasound processor 124 B.
  • the ultrasound processor 124 B can convert this voltage to an integer within a range (e.g., 0-1023 for a 10-bit analog-to-digital conversion).
  • the instrument guidance device 120 can send the position data, using for example Bluetooth® technology, to the computing device 110 .
  • the second sensor 123 B can provide power to the instrument guidance device 120 when the instrument guide device 125 is attached. Conversely, the second sensor 123 B can disengage power to the instrument guidance device 120 when the instrument guide device 125 is detached.
  • the computing device 110 can receive the imaging data and the position data from the ultrasound device 130 and the instrument guidance device 120 , respectively.
  • the computing device 110 can then generate an image overlay using the imaging data and the position data.
  • the image overlay can project the position data onto the imaging data.
  • the computing device 110 can display the image overlay on the display 116 of the computing device 110 or in some examples, the computing device 110 can send the image overlay to an external device and/or the ultrasound device 130 that displays the image overlay.
  • the computing device 110 can project the image overlay over a screen of the ultrasound device 130 , using for example lasers, or by placing a see-through screen over the screen of the ultrasound sound device 130 .
  • the position of an instrument can be mapped onto the imaging data that shows an image of the body.
  • a healthcare professional can see the position of an instrument and a blood vessel, which can eliminate errors.
  • the instrument guidance device 120 may need to be assembled prior to use.
  • the following embodiment refers to an instrument guide insert that is used with the instrument guide device 125 in place of the multi-faceted block (discussed above).
  • the instrument guide insert can be positioned over the instrument guide device 125 and pressed into the first aperture, which may make a snapping noise when inserted.
  • the instrument guide device 125 can be attached to an instrument guide bracket that contains holes that the one or more protrusions are sized to fit in.
  • ultrasound probe bracket 122 can be attached to the ultrasound probe 121 , for example, by aligning the ultrasound probe bracket 122 with the ultrasound probe 121 and pushing upwards until a clicking/snapping noise is audible and/or a tactile cue is felt.
  • the ultrasound probe 121 can be used to assemble the ultrasound probe bracket 122 in a pivoting motion. After attachment, an ultrasound probe cover can be placed over the ultrasound probe bracket 122 and the ultrasound probe 121 . Then, the assembled instrument guide device 125 can be attached to the ultrasound probe bracket 122 over the ultrasound probe cover to form a sterile barrier. In some examples, the instrument guide device 125 can attach to the ultrasound probe bracket 122 via a magnetic attachment, an adhesive attachment, a hook-and-loop strips attachment, and/or the like.
  • the instrument guide insert can include the one or more protrusions and/or one or more features that align with the one or more protrusions and/or the one or more features on the instrument guide device 125 such that the instrument guide insert snaps into pre-defined rotational positions as it is rotated to select apertures (e.g., a set of apertures) for different instrument sizes.
  • apertures e.g., a set of apertures
  • the instrument guide insert can be rotated one way to close the second aperture between the instrument guide insert and the instrument guide device 125 , and rotated another way to open the second aperture between the instrument guide insert and the instrument guide device 125 , such that the first instrument (e.g., the needle) can be removed from the instrument guidance device 120 in a direction perpendicular to the first instrument's central axis.
  • the instrument guide insert and/or the instrument guide device 125 can include a button and/or a lever that can be actuated to open and close the second aperture created between the instrument guide insert and instrument guide device 125 .
  • the ultrasound probe bracket 122 can include top portion 122 A and bottom portion 122 B (shown in FIG. 3B ) that can be joined together (e.g., snapped into place) to form the ultrasound probe bracket 122 .
  • the ultrasound probe bracket 122 can be opened about a hinge, fit around the ultrasound probe 121 , and then closed together while maintaining alignment.
  • the ultrasound probe bracket 122 can include a pin snap fit or a latch to join members of the ultrasound probe bracket 122 .
  • the ultrasound probe bracket 122 may fit the geometry of various sized ultrasound probes.
  • the ultrasound probe bracket 122 can be split into a plurality of pieces (e.g., halves) and/or can be opened and/or closed around the ultrasound probe 121 .
  • FIG. 4 shows a timing diagram of a method 400 for instrument guidance (e.g., using system 100 ).
  • the method 400 can be performed by the computing device 110 , the instrument guidance device 120 , and the ultrasound device 130 . Further, each of the aforementioned devices may be in communication with one another to perform the method 400 .
  • the ultrasound device 130 generates imaging data, i.e., an ultrasound image of a portion of a person's body. Then, at 404 , the ultrasound device 130 sends the imaging data to the computing device 110 .
  • the instrument guidance device 120 using the first sensor 123 A, can determine an angle of the instrument guide device 125 by tracking a magnet that is included within the instrument guide device 125 . The instrument guidance device 120 then generates, at 408 , position data based on the angle of the instrument guide device 125 .
  • the instrument guidance device 120 sends the position data to the computing device 110 .
  • the computing device can, at 412 , compute the pixel distance, for example on the display 116 or the ultrasound device 130 , corresponding to a physical metric in the ultrasound image (e.g., centimeters) at the present imaging depth.
  • the computing device 110 can compute how the position data should be displayed at the present imaging depth given the pixel distance determined at 412 .
  • the computing device 110 can generate an image overlay that projects the position data onto the imaging data, which can be displayed by the computing device 110 , at 418 .
  • the computing device 110 can send the image overlay to the ultrasound device 130 (as shown) and/or an external device.
  • FIG. 5 illustrates a flow chart of a method 500 for instrument guidance.
  • the method 500 is written from the perspective of the computing device 110 that can communicate with the instrument guidance device 120 , the ultrasound device 130 , and/or an external device. Using the method 500 can allow the computing device 110 to provide real-time imaging of both a patient's body and an instrument in relation to the patient's body.
  • the computing device 110 can receive imaging data from the ultrasound device 130 .
  • the computing device 110 can also receive position data from the instrument guidance device 120 , at 510 .
  • the computing device 110 can determine pixel distance on the display corresponding to a physical metric (e.g., centimeters) in the ultrasound image at the present imaging depth.
  • the computing device 110 can map a physical space in the imaging data onto a virtual display based on the pixel distance.
  • the computing device 110 can generate an image overlay that maps the position data (e.g., position of the needle and an trajectory of the needle) over the imaging data, such that the position of the instrument is shown in relation to the portion of the body being viewed by the ultrasound device 130 .
  • the computing device 110 can display the image overlay.

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Abstract

A system for instrument guidance is disclosed. The system can include an instrument guide device and a transducer system. The instrument guide device can include an instrument guide and an instrument guide bracket that includes a magnet, and the instrument guide bracket can be removably attachable to the instrument guide. The transducer system can include an ultrasound probe bracket that is removably attachable to an ultrasound probe. Further, the instrument guide device can removably attach to the ultrasound probe bracket. The ultrasound probe bracket can further include a first sensor and second sensor. The first sensor can wirelessly track a position of the magnet to determine position data of the instrument guidance system. And the second sensor can provide power or disengage power to the instrument guidance device when the instrument guide is attached or detached, respectively.

Description

    CROSS-REFERENCE TO RELATED APPLICATION
  • This application claims the benefit of, and priority under 35 U.S.C. § 119(e) to, U.S. Provisional Patent Application Nos. 62/814,004 and 62/866,950, filed Mar. 5, 2019 and Jun. 26, 2019, respectively, the contents of which are hereby incorporated by reference in its entirety as if fully set forth below.
  • FIELD OF THE INVENTION
  • The present invention relates generally to systems, methods, and devices for instrument guidance and, more particularly, to systems, methods, and devices for guiding the placement of instruments within the body using ultrasound imaging.
  • BACKGROUND
  • Ultrasound imaging can provide real-time two-dimensional imaging of a patient's body, which can be used to assist a healthcare professional to locate a region to insert an invasive medical device (e.g., a needle or a cylindrical instrument such a trocar, etc.). Once the healthcare professional locates the correct insertion point, the healthcare professional may then begin the medical procedure, such as insertion of a catheter, administration of a local anesthetic, or removal of tissue as in a biopsy. Determining at what orientation to insert the invasive medical device to ensure an unobstructed path to the target is challenging, as the ultrasound monitor can only display structures within the patient's body. It can also be difficult to tell what path the medical device will follow before the device enters the patient's body. Furthermore, after the medical device enters the patient's body, it can be difficult to accurately track the path and position of the medical device on the ultrasound monitor. Using the needle as an example—unless the needle is positioned exactly in-plane with the image, the needle may not be visible or may only be partially visible, which means that the needle location or, more importantly, the location of the needle tip is not precisely known. As such, the healthcare professional may make numerous attempts to insert the device before properly entering a tissue mass or penetrating a blood vessel. Further, in the case of a nerve, the healthcare professional can often only estimate the location of the needle end if it is not visible on the ultrasound image. As a result, patients may be injured or made to suffer unnecessary pain. From the healthcare professional's perspective, these procedures can be time consuming, and can expose the healthcare professional to liability. These and other drawbacks exist.
  • Accordingly, there is a need for improved systems, methods, and devices that provide guided instrument placement within the body.
  • SUMMARY
  • Aspects of the disclosed technology include systems, methods and devices for guided instrument placement. Consistent with the disclosed embodiments, an exemplary device can include an instrument guide device and a transducer system. The instrument guide device can comprise an instrument guide, an instrument guide insert, and an instrument guide bracket. The instrument guide can include a first aperture, a magnet, and one or more protrusions. The instrument guide can be configured to secure at least one instrument. Further, the instrument guide can be adaptable to secure instruments of different sizes. Turning to the instrument guide bracket, the instrument guide bracket can be removably attachable to the instrument guide when at least a first protrusion of the instrument guide engages with at least a first opening of the instrument guide bracket.
  • The transducer system can comprise an ultrasound probe bracket and an ultrasound probe. The ultrasound probe bracket can include a first sensor, a transceiver, and a processor. The first sensor can be configured to determine a position of the instrument guide device by wirelessly tracking the magnet located in the instrument guide. That is, as the instrument guide is moved around a body, the first sensor tracks the magnet to determine the position of the instrument guide device. The ultrasound probe bracket further includes a transceiver that is configured to receive the position of the instrument guide device from the first sensor, and then output the position to an external device (e.g., a computing device). The ultrasound probe bracket can further include a cutout sized to allow the instrument guide device to fit within and a member (e.g., snap features, protrusions, cutouts, and/or spring-loaded inserts) that allows the instrument guide device to removably attach to the ultrasound probe bracket. In some examples, rather than the cutout, the ultrasound probe bracket can include a single or pair of protruding features that provide attachment to the instrument guide bracket. The ultrasound probe bracket can be sized to fit around the ultrasound probe and can be removably attachable to the ultrasound probe. The ultrasound probe can generate and send image information to the processor. Then, the processor can generate position data using the position of the instrument guide device and/or the image information.
  • In some embodiments, the instrument guide can include a plurality of instrument guide inserts having different instrument sizes and/or gauges.
  • In some embodiments, the instrument guide can include a single insert that can be rotated to different positions to create different apertures sized to accommodate different instrument sizes and/or gauges.
  • According to some embodiments, the instrument guide insert can be sized to fit within the first aperture, wherein the at least one instrument is secured to the instrument guide insert.
  • In some embodiments, a first insert can be positioned into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket. Also, the first insert can be further positioned into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis and that the first insert induces friction that causes the instrument guide to maintain its orientation.
  • According to some embodiments, the ultrasound probe bracket is adaptable to fit a plurality of geometries.
  • In some embodiments, in response to movement of the instrument guidance system, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
  • In some embodiments, a first instrument is removably attachable to the instrument guide when the first instrument is inserted within a second aperture perpendicular to the instrument guide's axis of rotation.
  • In some embodiments, the instrument guide includes a rotation lock configured to allow and prevent rotation of the instrument guide.
  • According to some embodiments, the processor of the ultrasound probe bracket can determine whether the instrument guide is attached to the instrument guidance system. Also, the ultrasound probe bracket can include a second sensor configured to provide power and disengage power to the instrument guidance device when the instrument guide is attached or detached, respectively. It should be noted that the first sensor can perform all or some of the functions of the second sensor and vice versa.
  • An exemplary method includes a computing device receiving imaging data from an ultrasound device, which the computing device can display. The computing device can also communicate with an instrument guide device to receive position data that indicates an angle of an instrument attached to the instrument guide device. The computing device is preprogrammed with: 1) the physical location of the instrument guide device's axis of rotation relative to the imaging surface of the ultrasound transducer; and 2) an algorithm to compute the pixel distance on the display corresponding to a physical metric in the ultrasound image (e.g., centimeters) at any given imaging depth. Then, the computing device can determine where the trajectory of the instrument should lie on the ultrasound image in real-time. The generated image can then be displayed on a screen of the computing device, for example, as a graphical user interface (GUI).
  • In some embodiments, the ultrasound device can receive the position data from the instrument guide device and can generate the image overlay in a manner similar or identical to that disclosed above in reference to the computing device.
  • In some embodiments, the first sensor can be included in the instrument guide device rather than in the ultrasound probe bracket. In these embodiments, the ultrasound probe cover can include sealed, electrical ports, or contacts to enable electrical connection between the first sensor in the instrument guide device and the processor and/or transceiver in the ultrasound probe bracket, while maintaining a sterile barrier.
  • In some embodiments, the instrument guide device can be permanently coupled to the ultrasound probe cover, through methods such as adhesive or thermal bonding, such that attachment of the ultrasound probe cover and instrument guide device over/onto the ultrasound probe bracket can occur simultaneously.
  • Further features of the disclosed design, and the advantages offered thereby, are explained in greater detail hereinafter with reference to specific embodiments illustrated in the accompanying drawings, wherein like elements are indicated by like reference designators.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, are incorporated into and constitute a portion of this disclosure, illustrate various implementations and aspects of the disclosed technology, and, together with the description, serve to explain the principles of the disclosed technology. In the drawings:
  • FIG. 1 is an example system for instrument guidance, in accordance with some examples of the present disclosure;
  • FIG. 2A is an isometric view of an instrument guidance device, in accordance with some examples of the present disclosure;
  • FIG. 2B is a top view of an instrument guidance device, in accordance with some examples of the present disclosure;
  • FIG. 2C is a top view of an instrument guide device, in accordance with some examples of the present disclosure;
  • FIG. 3A is an isometric view of an ultrasound probe bracket and an attached instrument guide device, in accordance with some examples of the present disclosure;
  • FIG. 3B is an exploded view of an ultrasound probe bracket, in accordance with some examples of the present disclosure;
  • FIG. 4 is an example timing diagram for instrument guidance, in accordance with some examples of the present disclosure; and
  • FIG. 5 is an example flow chart of a method for instrument guidance, in accordance with some examples of the present disclosure.
  • DETAILED DESCRIPTION
  • Some implementations of the disclosed technology will be described more fully with reference to the accompanying drawings. This disclosed technology can be embodied in many different forms, however, and should not be construed as limited to the implementations set forth herein. The components described hereinafter as making up various elements of the disclosed technology are intended to be illustrative and not restrictive. Many suitable components that would perform the same or similar functions as components described herein are intended to be embraced within the scope of the disclosed electronic devices and methods. Such other components not described herein can include, but are not limited to, for example, components developed after development of the disclosed technology.
  • It is also to be understood that the mention of one or more method steps does not imply that the methods steps must be performed in a particular order or preclude the presence of additional method steps or intervening method steps between the steps expressly identified.
  • Reference will now be made in detail to exemplary embodiments of the disclosed technology, examples of which are illustrated in the accompanying drawings and disclosed herein. Wherever convenient, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
  • FIG. 1 is a schematic of an exemplary system 100 used for instrument guidance. As shown, the system 100 includes a computing device 110, an instrument guidance device 120, and an ultrasound device 130. The instrument guide device 125 can include a first aperture, a magnet, and one or more protrusions. In some examples, rather than the magnet the instrument guide device 125 can include a sensing element (e.g., a potentiometer, a feature to engage with a potentiometer, an optical sensing element that can be used by an optical sensor, and/or a capacitive sensing element that can be used by a capacitive sensor). Further, the sensing element can be contained in an instrument guide insert that is attached to the instrument guide device 125. The computing device 110 can include one or more processors 112, transceiver 114, and display 116, among other things. The computing device 110 can communicate with the instrument guidance device 120 and/or the ultrasound device 130.
  • As one skilled in the art would understand, the ultrasound device 130 can emit high-frequency sound waves that, when a transducer of the ultrasound device 130 is placed against a body, reflect off body structures. The ultrasound device 130 can then receive the waves and can use the waves to create imaging data. Here, the ultrasound device 130 can send the imaging data in real-time to the computing device 110.
  • As shown in FIGS. 2A-B, the instrument guidance device 120 can include ultrasound probe 121, ultrasound probe bracket 122, instrument guide device 125, first sensor 123A, second sensor 123B, ultrasound transceiver 124A, and ultrasound processor 124B. The ultrasound transceiver 124A can be located in ultrasound probe bracket 122 and can transmit various data including position data and a unique identifier for the ultrasound probe 121. The first sensor 123A and/or second sensor 123B can be a magnetoresistive sensor, Hall effect sensor, magnetic potentiometer, and/or the like that can be configured to detect a magnetic field and changes as the magnetic field is rotated and/or translated.
  • Turning to use of the instrument guidance device 120, a user (e.g., a physician) can place the instrument guidance device 120 near a portion of the body (e.g., the neck) to approximate an area to insert an instrument. The instrument guide device 125 of the instrument guidance device 120 can hold one or more instruments of differing sizes, which can be attributed to a multi-faceted block which can rotate beside an open channel to create a closed channel of variable size (shown in FIG. 2C). Additionally or alternatively, the instrument guide device 125 can include a plurality of disposable instrument inserts that are each designed to fit a specific instrument guide, but each has a consistent outer geometry to attach. Also, the instrument guide device 125 can include a single instrument insert that includes a plurality of faces or a single continuous face that when the instrument insert is twisted, changes the size of a second aperture created between the instrument insert and the instrument guide device 125, which can allow for different instrument sizes and/or gauges to be used. In some examples, the instrument guide device 125 can be a single disposable instrument guide that accepts a plurality of instrument sizes. An instrument inserted into the instrument guide device 125 can be indirectly and/or removably attached or attachable to the ultrasound probe 121.
  • As the user moves the instrument guidance device 120, the magnet can change orientation accordingly; however, the magnet can be in a fixed position in rotating element of the instrument guidance device 120, such that the magnet does not change the angle and/or position relative to the rotating element. The first sensor 123A can wirelessly track the magnet, using for example magnetoresistive properties that rely on the magnetic field, to determine an orientation (e.g., angle) and/or position of the instrument guide device 125. Then, the ultrasound processor 124B can generate position data (e.g., angle and positioning values), which can be in relation to the surface of the ultrasound probe 121. More specifically, the first sensor 123A can send a voltage within a range (e.g., 0-3.3 volts) corresponding to the angle of the magnet to the ultrasound processor 124B. The ultrasound processor 124B can convert this voltage to an integer within a range (e.g., 0-1023 for a 10-bit analog-to-digital conversion). Using the transceiver 124A, the instrument guidance device 120 can send the position data, using for example Bluetooth® technology, to the computing device 110.
  • Furthermore, the second sensor 123B can provide power to the instrument guidance device 120 when the instrument guide device 125 is attached. Conversely, the second sensor 123B can disengage power to the instrument guidance device 120 when the instrument guide device 125 is detached.
  • Referring to the computing device 110, the computing device 110 can receive the imaging data and the position data from the ultrasound device 130 and the instrument guidance device 120, respectively. The computing device 110 can then generate an image overlay using the imaging data and the position data. The image overlay can project the position data onto the imaging data. Further, the computing device 110 can display the image overlay on the display 116 of the computing device 110 or in some examples, the computing device 110 can send the image overlay to an external device and/or the ultrasound device 130 that displays the image overlay. Additionally or alternatively, the computing device 110 can project the image overlay over a screen of the ultrasound device 130, using for example lasers, or by placing a see-through screen over the screen of the ultrasound sound device 130. In other words, the position of an instrument can be mapped onto the imaging data that shows an image of the body. Thus, in real-time, for example, a healthcare professional can see the position of an instrument and a blood vessel, which can eliminate errors.
  • In some examples, the instrument guidance device 120 may need to be assembled prior to use. The following embodiment refers to an instrument guide insert that is used with the instrument guide device 125 in place of the multi-faceted block (discussed above). The instrument guide insert can be positioned over the instrument guide device 125 and pressed into the first aperture, which may make a snapping noise when inserted. Next, the instrument guide device 125 can be attached to an instrument guide bracket that contains holes that the one or more protrusions are sized to fit in. Then, ultrasound probe bracket 122 can be attached to the ultrasound probe 121, for example, by aligning the ultrasound probe bracket 122 with the ultrasound probe 121 and pushing upwards until a clicking/snapping noise is audible and/or a tactile cue is felt. Additionally or alternatively, the ultrasound probe 121 can be used to assemble the ultrasound probe bracket 122 in a pivoting motion. After attachment, an ultrasound probe cover can be placed over the ultrasound probe bracket 122 and the ultrasound probe 121. Then, the assembled instrument guide device 125 can be attached to the ultrasound probe bracket 122 over the ultrasound probe cover to form a sterile barrier. In some examples, the instrument guide device 125 can attach to the ultrasound probe bracket 122 via a magnetic attachment, an adhesive attachment, a hook-and-loop strips attachment, and/or the like.
  • Referring to the instrument guide insert, the instrument guide insert can include the one or more protrusions and/or one or more features that align with the one or more protrusions and/or the one or more features on the instrument guide device 125 such that the instrument guide insert snaps into pre-defined rotational positions as it is rotated to select apertures (e.g., a set of apertures) for different instrument sizes. Also, the instrument guide insert can be rotated one way to close the second aperture between the instrument guide insert and the instrument guide device 125, and rotated another way to open the second aperture between the instrument guide insert and the instrument guide device 125, such that the first instrument (e.g., the needle) can be removed from the instrument guidance device 120 in a direction perpendicular to the first instrument's central axis. The instrument guide insert and/or the instrument guide device 125 can include a button and/or a lever that can be actuated to open and close the second aperture created between the instrument guide insert and instrument guide device 125.
  • The ultrasound probe bracket 122 can include top portion 122A and bottom portion 122B (shown in FIG. 3B) that can be joined together (e.g., snapped into place) to form the ultrasound probe bracket 122. In some examples, the ultrasound probe bracket 122 can be opened about a hinge, fit around the ultrasound probe 121, and then closed together while maintaining alignment. In other examples, the ultrasound probe bracket 122 can include a pin snap fit or a latch to join members of the ultrasound probe bracket 122. Thus, the ultrasound probe bracket 122 may fit the geometry of various sized ultrasound probes. Further, the ultrasound probe bracket 122 can be split into a plurality of pieces (e.g., halves) and/or can be opened and/or closed around the ultrasound probe 121.
  • FIG. 4 shows a timing diagram of a method 400 for instrument guidance (e.g., using system 100). Thus, the method 400 can be performed by the computing device 110, the instrument guidance device 120, and the ultrasound device 130. Further, each of the aforementioned devices may be in communication with one another to perform the method 400.
  • At 402, the ultrasound device 130 generates imaging data, i.e., an ultrasound image of a portion of a person's body. Then, at 404, the ultrasound device 130 sends the imaging data to the computing device 110. Next, at 406, the instrument guidance device 120, using the first sensor 123A, can determine an angle of the instrument guide device 125 by tracking a magnet that is included within the instrument guide device 125. The instrument guidance device 120 then generates, at 408, position data based on the angle of the instrument guide device 125. At 410, the instrument guidance device 120 sends the position data to the computing device 110. The computing device can, at 412, compute the pixel distance, for example on the display 116 or the ultrasound device 130, corresponding to a physical metric in the ultrasound image (e.g., centimeters) at the present imaging depth.
  • Next, at 414, the computing device 110 can compute how the position data should be displayed at the present imaging depth given the pixel distance determined at 412. At 416, the computing device 110 can generate an image overlay that projects the position data onto the imaging data, which can be displayed by the computing device 110, at 418. At 420, the computing device 110 can send the image overlay to the ultrasound device 130 (as shown) and/or an external device.
  • FIG. 5 illustrates a flow chart of a method 500 for instrument guidance. The method 500 is written from the perspective of the computing device 110 that can communicate with the instrument guidance device 120, the ultrasound device 130, and/or an external device. Using the method 500 can allow the computing device 110 to provide real-time imaging of both a patient's body and an instrument in relation to the patient's body.
  • At 505, the computing device 110 can receive imaging data from the ultrasound device 130. The computing device 110 can also receive position data from the instrument guidance device 120, at 510. At 515, the computing device 110 can determine pixel distance on the display corresponding to a physical metric (e.g., centimeters) in the ultrasound image at the present imaging depth. At 520, the computing device 110 can map a physical space in the imaging data onto a virtual display based on the pixel distance. Then, at 525, the computing device 110 can generate an image overlay that maps the position data (e.g., position of the needle and an trajectory of the needle) over the imaging data, such that the position of the instrument is shown in relation to the portion of the body being viewed by the ultrasound device 130. At 530, the computing device 110 can display the image overlay.
  • Throughout the specification and the claims, the following terms take at least the meanings explicitly associated herein, unless the context clearly dictates otherwise. The term “or” is intended to mean an inclusive “or.” Further, the terms “a,” “an,” and “the” are intended to mean one or more unless specified otherwise or clear from the context to be directed to a singular form.
  • In this description, numerous specific details have been set forth. It is to be understood, however, that implementations of the disclosed technology can be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description. References to “one embodiment,” “an embodiment,” “some embodiments,” “example embodiment,” “various embodiments,” “one implementation,” “an implementation,” “example implementation,” “various implementations,” “some implementations,” etc., indicate that the implementation(s) of the disclosed technology so described can include a particular feature, structure, or characteristic, but not every implementation necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase “in one implementation” does not necessarily refer to the same implementation, although it can.
  • As used herein, unless otherwise specified the use of the ordinal adjectives “first,” “second,” “third,” etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.
  • While certain implementations of the disclosed technology have been described in connection with what is presently considered to be the most practical and various implementations, it is to be understood that the disclosed technology is not to be limited to the disclosed implementations, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
  • This written description uses examples to disclose certain implementations of the disclosed technology, including the best mode, and also to enable any person skilled in the art to practice certain implementations of the disclosed technology, including making and using any devices or systems and performing any incorporated methods. The patentable scope of certain implementations of the disclosed technology is defined in the claims, and can include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.

Claims (20)

What is claimed is:
1. An instrument guidance device comprising:
an instrument guide device comprising:
an instrument guide comprising a first aperture, a magnet, and one or more protrusions, wherein the instrument guide is configured to secure at least one instrument, and
an instrument guide bracket comprising a plurality of openings located at one or more side surfaces, wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion from the one or more protrusions engages with at least a first opening from the plurality of openings; and
a transducer system comprising:
an ultrasound probe bracket comprising:
a first sensor configured to determine a position of the instrument guide device by wirelessly tracking the magnet and configured to transmit the position of the instrument guide device, and
a transceiver configured to receive the position of the instrument guide device from the first sensor and output the position to an external device,
a processor configured to generate position data based on the position of the instrument guide device,
the ultrasound probe bracket sized to fit the ultrasound probe, wherein the ultrasound probe bracket is removably attachable to the ultrasound probe.
2. The instrument guidance device of claim 1, wherein:
the instrument guide further comprises an instrument guide insert that is sized to fit within the first aperture,
the instrument guide insert is sized to accommodate a first instrument having a specific instrument size in a second aperture created between the instrument guide insert and the instrument guide, and
the instrument guide insert is configured to turn between an open position and closed position such that the instrument guidance device is removable from the first instrument while the first instrument is inserted in a portion of a body.
3. The instrument guidance device of claim 1, further comprising a plurality of instrument guide inserts, wherein each of the plurality of instrument guide inserts can accommodate a different instrument size.
4. The instrument guidance device of claim 1, further comprising an instrument guide insert, wherein:
the instrument guide insert has a plurality of faces,
when the instrument guide insert is rotated, each of the plurality of faces aligns with an open channel in the instrument guide to create a closed channel that is sized to accommodate a specific instrument size, and
each of the plurality of faces of the instrument guide insert corresponds to a different instrument size, such that the instrument guide insert can be rotated to select from a set of apertures depending on a desired instrument size.
5. The instrument guidance device of claim 1, wherein a first insert is insertable into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket such that the first insert intersects with a portion of the instrument guide to lock and/or induce friction on rotation of the instrument guide.
6. The instrument guidance device of claim 1, wherein a first insert is insertable into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket such that when the first insert is tightened it deforms the instrument guide bracket and reduces the size of a cutout in the instrument guide bracket within which at least one protrusion of the one or more protrusions rotates.
7. The instrument guidance device of claim 1, wherein a second insert is insertable into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis.
8. The instrument guidance device of claim 1, wherein the ultrasound probe bracket is adaptable to fit a plurality of geometries.
9. The instrument guidance device of claim 1, wherein in response to movement of the instrument guidance device, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
10. The instrument guidance device of claim 1, wherein the instrument guide further comprises a rotation lock configured to allow and prevent rotation of the instrument guide.
11. The instrument guidance device of claim 1, wherein:
the processor is further configured to determine whether the instrument guide is attached to the instrument guidance device; and the instrument guidance device further comprises:
a second sensor configured to:
provide power to the instrument guidance device when the instrument guide is attached, and
disengage power to the instrument guidance device when the instrument guide is detached.
12. A system for instrument guidance, the system comprising:
a computing device comprising a first processor, a first transceiver, and a screen;
an instrument guidance device comprising an instrument guide device and a transducer system, the instrument guidance device configured to:
determine, by a first sensor of the transducer system, a position of the instrument guide device by wirelessly tracking a magnet located in the instrument guide device;
receive, by a second transceiver of the transducer system, the position of the instrument guide device from the first sensor;
generate, by a second processor of the transducer system, position data based on the position of the instrument guide device, the position data indicating a position with respect to a surface of an attached ultrasound transducer of an instrument attached to the instrument guidance device; and
send, by the second transceiver, the position data to a computing device;
an ultrasound device configured to:
generate imaging data representative of a portion of a human body; and
send the imaging data to the computing device; and
wherein the computing device is configured to:
receive, by the first transceiver, the imaging data from the ultrasound device;
receive, by the first transceiver, the position data from the instrument guidance device;
determine, by the first processor, how physical space in the imaging data is mapped on a virtual display;
generate, by the first processor, an image overlay that projects the position data onto the imaging data, wherein an instrument trajectory is shown in relation to the imaging data; and
display, by the screen, the image overlay.
13. The system of claim 12, wherein the instrument guide device comprises:
an instrument guide comprising an aperture, a magnet, and one or more protrusions, wherein the instrument guide is configured to secure at least one instrument; and
an instrument guide bracket comprising a plurality of openings located at one or more side surfaces, wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion from the one or more protrusions engages with at least a first opening from the plurality of openings.
14. The system of claim 13, wherein the instrument guide further comprises an instrument guide insert that is sized to fit within the aperture, and wherein the at least one instrument is secured to the instrument guide insert.
15. The system of claim 14, wherein the instrument guide insert is adaptable to accommodate instruments of different sizes.
16. The system of claim 13, wherein an insert is insertable into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket and the insert is further insertable into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis.
17. The system of claim 13, wherein in response to movement of the instrument guidance system, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
18. The system of claim 13, wherein the transducer system further comprises:
an ultrasound probe bracket, wherein the first sensor, the second transceiver, and the second processor are position with the ultrasound probe bracket;
a cut-out space configured to allow the instrument guide device to removably attach to the ultrasound probe bracket; and
an ultrasound probe sized to fit within the ultrasound probe bracket, wherein the ultrasound probe is removably attachable to the ultrasound probe bracket.
19. The system of claim 18, wherein the second processor is configured to determine whether the instrument guide is attached to the instrument guidance system, and the ultrasound probe bracket further comprises:
a second sensor configured to:
provide power to the instrument guidance device when the instrument guide is attached, and
disengage power to the instrument guidance device when the instrument guide is detached.
20. A method for real-time instrument guidance placement comprising:
receiving, by a transceiver of a computing device, imaging data from an ultrasound probe, the imaging data representative of a portion of a human body;
receiving, by the transceiver, position data from an instrument guide device, the position data indicating a position with respect to a surface of an attached ultrasound probe of an instrument attached to the instrument guide device;
determining, by a processor of the computing device, pixel distance of the imaging data at a predetermined imaging depth;
mapping, by the processor, a physical space in the imaging data onto a virtual display based on the pixel distance;
generating, by the processor, an image overlay that projects the position data onto the imaging data, wherein an instrument trajectory is shown in relation to the imaging data; and
displaying, by a screen of the computing device, the image overlay.
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US16/816,363 US11701088B2 (en) 2019-03-05 2020-03-12 Systems, methods, and devices for instrument guidance
AU2020304669A AU2020304669A1 (en) 2019-06-26 2020-06-26 Systems, methods, and devices for instrument guidance
JP2021576834A JP2022538126A (en) 2019-06-26 2020-06-26 Systems, methods and apparatus for instrument guidance
EP20832232.1A EP3989850A4 (en) 2019-06-26 2020-06-26 Systems, methods, and devices for instrument guidance
CA3139694A CA3139694A1 (en) 2019-06-26 2020-06-26 Systems, methods, and devices for instrument guidance
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