CN113204224B - Instruction testing system of external control equipment for implantable medical device - Google Patents
Instruction testing system of external control equipment for implantable medical device Download PDFInfo
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B23/00—Testing or monitoring of control systems or parts thereof
- G05B23/02—Electric testing or monitoring
- G05B23/0205—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults
- G05B23/0218—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults characterised by the fault detection method dealing with either existing or incipient faults
- G05B23/0256—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults characterised by the fault detection method dealing with either existing or incipient faults injecting test signals and analyzing monitored process response, e.g. injecting the test signal while interrupting the normal operation of the monitored system; superimposing the test signal onto a control signal during normal operation of the monitored system
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Abstract
The invention provides an instruction testing system of an external control device for an implantable medical device, which comprises: test fixture and computer; the test fixture is provided with implantable medical instrument simulation equipment, an induction coil and a test board, and is used for changing the relative positions of the simulation equipment and the induction coil; the test board is provided with an interface for connecting a tested object and the induction coil; the computer is respectively connected with the test board and the simulation equipment and is used for controlling the tested object to send a control instruction to the simulation equipment through the induction coil so as to enable the simulation equipment to execute actions corresponding to the control instruction, obtain action execution results fed back by the simulation equipment and send, execute and analyze results of the instructions fed back by the tested object.
Description
Technical Field
The invention relates to the technical field of medical equipment detection, in particular to an instruction testing system of an external control device for an implantable medical instrument.
Background
A body implantable medical device (Implantable Medical Device, IMD) is a medical device that is mounted inside the body of a user, such device having a battery, a circuit board (with sensors, chips, etc.) and the IMD implements a corresponding therapy by means of a set program and operating parameters that can be set differently according to the condition of the user. Because of the different causes and conditions of the users, implantable medical devices installed in different users generally have different operating states, which are represented in many aspects of battery voltage, operating time, power, current magnitude, frequency, etc. of the implantable medical devices.
The external control equipment is used in cooperation with the implanted medical device and is used for adjusting the running state of the implanted medical device to enable the running state of the implanted medical device to meet the treatment requirements of users. In order to ensure the stability and safety of the external control equipment, the external control equipment is required to be comprehensively detected, the existing scheme adopts manual detection to detect the whole machine, the detection mode is low in efficiency, the external control equipment has close relationship with the active implantable medical equipment, the active implantable medical equipment is required to be added in the detection process, the detection operation difficulty is high, and the whole machine of the controlled equipment comprises a circuit board, a battery, an electromagnetic induction coil and other components, so that the pertinence of the detection process is required to be improved.
Disclosure of Invention
In view of the above, the present invention provides a command test system of an external control device for an implantable medical device, comprising:
a displacement platform and a computer;
the displacement platform is provided with implantable medical instrument simulation equipment, an induction coil and a test board, and is used for changing the relative positions of the simulation equipment and the induction coil;
the test board is provided with an interface for connecting a tested object and the induction coil, and the tested object is external control equipment or a circuit board thereof;
The computer is respectively connected with the test board and the simulation equipment and is used for controlling the tested object to send a control instruction to the simulation equipment through the induction coil so as to enable the simulation equipment to execute actions corresponding to the control instruction, obtain action execution results fed back by the simulation equipment and send, execute and analyze results of the instructions fed back by the tested object.
Optionally, the computer is used for controlling the displacement platform to change the relative position, and controlling the measured object to send a control instruction to the simulation equipment through the induction coil under a plurality of relative positions.
Optionally, the computer judges the action execution result and the instruction sending result at each relative position, and controls the displacement platform to set the simulation device and the induction coil at a preset relative position after confirming the normal state.
Optionally, the control instructions are for changing parameters of the stimulation signal output by the analog device.
Optionally, the system further comprises a collection card, which is used for collecting the stimulation signals output by the simulation equipment; the computer determines the action execution result by acquiring the stimulus signal.
Optionally, the control instruction is used for enabling the simulation equipment to send state information to the tested object; the computer is used for reading the state information of the simulation equipment and acquiring the state information received by the tested object.
Optionally, the control instruction is used for enabling the analog device to turn on or off a functional module therein; the computer is used for acquiring the state information of the functional module.
Optionally, the object to be tested is a circuit board; the circuit board comprises a base part and a tested part, wherein the tested part is a circuit board of an in-vitro control device;
the base is provided with a through hole for accommodating the tested part, and the edge of the tested part is connected with the edge of the through hole through a plurality of cuttable parts;
and one end of the base is provided with a plurality of interfaces for connecting the test board, and the interfaces are connected with the connection points on the tested part through wires arranged in the base and the tested part.
Optionally, a wireless communication module is arranged on the test board, and the computer is in wireless connection with the tested object through the wireless communication module.
Optionally, the computer is further configured to obtain a wireless communication signal strength of the object under test.
The test system provided by the invention utilizes the simulation equipment to simulate the implanted medical instrument, utilizes the induction coil to simulate the coil of the external control equipment, so that a tested object is in an actual working environment, and utilizes the displacement platform to change the relative positions of the simulation equipment and the induction coil, so as to simulate communication operation possibly occurring in the actual use process of a user, and utilizes the computer to control the tested object to send an instruction to the simulation equipment, and acquire the execution condition of the simulation equipment on the instruction, so as to determine whether the instruction sending function of the external control equipment is normal or not.
Drawings
The features and advantages of the present invention will be more clearly understood by reference to the accompanying drawings, which are illustrative and should not be construed as limiting the invention in any way, in which:
FIG. 1 is a schematic diagram of an instruction testing system according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a test circuit board and a tested circuit board according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of a charging test system according to an embodiment of the present invention;
FIG. 4 is a schematic diagram of a test circuit board according to an embodiment of the invention;
fig. 5 is a schematic structural diagram of a load configuration unit according to an embodiment of the present invention;
FIG. 6 is a schematic diagram of an induction coil according to an embodiment of the present invention;
FIG. 7 is a schematic diagram of a testing system for electromagnetic induction coils according to an embodiment of the present invention;
FIG. 8 is a schematic structural diagram of a test fixture according to an embodiment of the present invention;
fig. 9 is a schematic structural diagram of another view angle of the test tool according to the embodiment of the invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The embodiment of the invention provides an instruction testing system of an external control device for an implantable medical instrument, which can be used for detecting external controllers of charged and uncharged implantable medical instruments such as DBS (deep brain stimulation ), VNS (vagusneve stimulation, vagus nerve stimulation), SCS (Spinal cord stimulation, spinal cord electrical stimulation) and SNM (Sacral Neuromodulation, sacral nerve stimulation system). As shown in fig. 1, the system includes: computer 1, power 2 and test fixture. The test tool is provided with an implantable medical instrument simulation device (hereinafter referred to as simulation device or IPG) 8, an induction coil 7 and a test board 5, and is used for adjusting the relative positions of the in-vivo simulation device 8 and the induction coil 7.
The specific structure of the test fixture has various choices, for example, an electric device with one or more guide rails can be used, and the in-vivo simulation device 8 and the induction coil 7 can be respectively placed on two platforms capable of realizing relative movement, so that the position change between the two platforms can be realized. The object to be tested in the embodiment of the invention can be an in-vitro control device or a circuit board of the device). The induction coil 7 is part of the present test system, simulating the charging and communication coils of the extracorporeal control apparatus; the in-vivo simulation device 8 simulates an implantable medical instrument, and an induction coil is also arranged inside the in-vivo simulation device 8. The relative positions in this embodiment may be relative distances, and may also include relative angles, etc., depending on the structure of the test fixture, and the present invention provides a preferred structure, which will be described in detail in the following embodiments.
The test board 5 is provided with an interface for connecting the object 6 to be tested and the induction coil 7, the induction coil 7 is connected with the object 6 to be tested through the interface, and the control circuit is used for receiving and processing the instructions of the computer 1, sending the instructions to the object 6 to be tested and reading the information in the instructions, and controlling other elements and the like on the test board 5. In one embodiment, the object 6 is an external control device, and in order to adapt to various types and models of external control devices, an interface for connecting the object 6 is set as a universal interface, and is connected with an interface reserved for updating a program on the external control device through a switching device.
In another embodiment, the object 6 is a circuit board of an extracorporeal control apparatus. As shown in fig. 2, the circuit board connected to the test board 5 includes a base portion 61 and a portion under test 62, wherein the portion under test 62 is a circuit board of an extracorporeal control apparatus. The base 61 is provided with a through hole for accommodating the measured portion 62, and the edge of the measured portion 62 is connected with the edge of the through hole through a plurality of cuttable portions 63. One end of the base 61 is provided with a plurality of unified interfaces 64 for connecting the test board 5, and the unified interfaces 64 are connected to connection points on the tested part 62 through wires provided in the base 61 and the tested part 62, respectively. The unified interface 64 may specifically be in the form of a golden finger jack, a flat cable, or an air plug.
According to the circuit board, the base is surrounded around the tested part, when the test is needed, an operator or a manipulator and other equipment can clamp the base to plug in the test board, the base serves as an actual stressed object, the tested part can be well protected, and the tested part can be cut off from the base after the test is completed, so that the whole test process is safe and convenient.
The computer 1 controls the test flow, configures the hardware environment, sends the test instruction, acquires the test parameters, judges and stores the test result.
Specifically, the computer 1 is connected to the test board 5, the in-vivo simulation device 8, and the power supply 2, respectively. Wherein the power supply 2 is connected to the test board 5, in this embodiment supplying power to the test board 5 and the object 6 to be tested. The in-vivo simulation device 8 may be configured with a separate battery as its power source or may also be powered by the power source 2. The computer 1 can be connected with the test board 5 through a serial port or a network cable interface, and controls the tested object 6 to send a control instruction to the in-vivo simulation device 8 through the induction coil 7 so as to enable the in-vivo simulation device 8 to execute actions corresponding to the control instruction. The computer 1 obtains the action execution result of the in-vivo simulation device 8, obtains the instruction sending and execution condition judging result fed back by the tested object 6 through a wired connection mode such as a serial port, determines whether the function of the tested object 6 for sending a control instruction is normal by judging whether the instruction sending and the execution are consistent, and determines whether the execution judging function fed back by the tested object 6 is normal by the actual instruction execution condition.
Before the computer 1 controls the tested object 6 to send out a control instruction, the test tool is adjusted to enable the induction coil 7 and the in-vivo simulation device 8 to be in a static relative position. The relative position may be a preset fixed position, may be different fixed positions according to the type or model of the object 6 to be measured, or may be a uniform fixed position.
The system can be used for testing various control instructions. In one embodiment, the control instructions are used to change parameters of the stimulation signal output by the in vivo simulation device 8. Specifically, the computer 1 sends control information to the subject 6 via the test board 5, causing it to send an instruction to change the stimulation parameters, such as the stimulation frequency, amplitude, electrode outputting the stimulation signal, etc., to the in-vivo simulation device 8 via the induction coil 7. If the in vivo simulation device 8 is able to receive the control instructions and the instruction content is correct, the corresponding action, i.e. changing the above-mentioned stimulation parameters, should be performed.
There are various methods for the computer 1 to acquire the action execution result fed back by the in-vivo simulation device 8, and in this embodiment, the signal acquisition card 9 acquires the stimulation signal output by the in-vivo simulation device 8 and transmits the stimulation signal to the computer 1. The computer 1 determines the action execution result by judging the waveform of the stimulation signal, namely, judges whether the signal frequency and the amplitude of the stimulation signal are consistent with the content indicated by the control instruction or not by judging the waveform of the stimulation signal. The in-vivo simulation device 8 has a plurality of output electrodes, and the acquisition card 9 can acquire signals of the respective output electrodes, respectively, so that the computer 1 determines which output electrode outputs the stimulation signal.
In another embodiment, the control instructions are for causing the in vivo simulation device 8 to send status information to the subject 6. Specifically, the computer 1 sends control information to the subject 6 through the test board 5, so that it sends an instruction for feeding back status information, such as feeding back the current stimulation frequency, amplitude, electrodes outputting stimulation signals, etc., to the in-vivo simulation device 8 through the induction coil 7. If the in-vivo simulation device 8 is able to receive the control instructions and the instruction content is correct, the corresponding action, i.e. feedback of the state of itself, should be performed.
In the present embodiment, the stimulating signal output by the in-vivo simulation device 8 is collected by the signal collection card 9 and transmitted to the computer 1. The computer 1 determines whether the working state of the in-vivo simulation device 8 is consistent with the state information received by the tested object 6 by judging the waveform of the stimulation signal, namely, judges whether the signal frequency and the amplitude of the stimulation signal are consistent with the content indicated by the state information by judging the waveform of the stimulation signal.
In the third embodiment, the control instruction is used to cause the in-vivo simulation device 8 to turn on or off a functional module therein, such as a bluetooth communication module, a stimulus output module, and the like. Specifically, the computer 1 sends control information to the subject 6 through the test board 5, so that it sends an instruction to turn on or off a certain functional module, such as turning on or off bluetooth, turning on or off stimulus output, etc., to the in-vivo simulation device 8 through the induction coil 7. If the in-vivo simulation device 8 is able to receive the control instructions and the instruction content is correct, the corresponding actions should be performed. The computer 1 is configured to obtain status information of a corresponding functional module, for example, the computer 1 collects, through an ammeter, a dc power supply, or an acquisition card, a working current value of the in-vivo simulation device 8 at this time, and if the current increases and the current value is within an expected standard range, the computer can determine that the bluetooth-on instruction is sent and executed successfully.
The test system provided by the embodiment of the invention utilizes the simulation equipment to simulate the implanted medical instrument, utilizes the induction coil to simulate the coil of the external control equipment, enables the tested object to be in an actual working environment, and utilizes the displacement platform to change the relative positions of the simulation equipment and the induction coil so as to simulate the communication operation possibly occurring in the actual use process of a user, controls the tested object to send an instruction to the simulation equipment through a computer, and obtains the execution condition of the instruction by the simulation equipment so as to determine whether the instruction sending function of the external control equipment is normal or not.
In order to eliminate the influence of the wireless communication distance between the induction coil 7 and the in-vivo simulation device 8 on the test result, during the test, the computer 1 controls the test tool to control the tested object 6 to send control instructions to the in-vivo simulation device 8 through the induction coil 7 at a plurality of relative positions, such as sending control instructions at a shortest distance and sending control instructions at a maximum distance. The computer 1 determines whether the transmission and execution conditions of the instructions at each position are consistent (referred to as distance traversal test). After confirming that the command transmission and execution conditions at each position are consistent, the test fixture is controlled to adjust the induction coil 7 and the in-vivo simulation device 8 to a preset relative position (between the shortest distance and the maximum distance), the tested object 6 is controlled to transmit the command to the in-vivo simulation device 8 through the induction coil 7 again, and whether the command transmission and execution conditions are consistent is judged (called as formal test).
The distance traversal test can be used as a conventional test item, namely, the distance traversal test is used for each product; the system can also only aim at new products, and a distance traversal test is adopted when the system is used for testing the first new product for the first time, so that the fact that the instruction is executable under each distance is determined, interference of distance factors on test results is eliminated, and then the distance traversal test can not be used when the same products are tested, and only formal test is adopted.
In an alternative embodiment, the test board 5 is provided with a wireless communication module, and the computer 1 is wirelessly connected with the tested object 6 through the wireless communication module, and sends control information to the tested object 6 or reads state information therein through wireless communication modes such as WiFi, bluetooth, PPM and the like. The object 6 is adjusted to a wireless communication state, and the computer 1 reads the signal intensity of the object 6 by using the wireless communication module to test whether the wireless communication function is normal.
The embodiment of the invention provides a charging test system of an external control device for an implantable medical instrument, which can be used for detecting external controllers of the implantable medical instrument such as DBS (deep brain stimulation ), VNS (vagusneve stimulation, vagus nerve stimulation), SCS (Spinal cord stimulation, spinal cord electrical stimulation) and SNM (Sacral Neuromodulation, sacral nerve stimulation system). As shown in fig. 3, the system includes: computer 1, power 2, battery simulator 3 and test fixture. The test tool is provided with an implantable medical instrument simulation device (hereinafter referred to as simulation device or IPG) 8, an induction coil 7 and a test board 5, and is used for adjusting the relative positions of the in-vivo simulation device 8 and the induction coil 7.
Reference is made in particular to the above-described embodiments, and to several alternative constructions provided hereinafter, for a test fixture.
The test board 5 is provided with an interface for connecting the object 6 to be tested and an induction coil 7, and the induction coil 7 is connected with the object 6 to be tested through the interface. Similar to the above embodiment, the object 6 may be the whole machine of the extracorporeal control apparatus or a circuit board thereof.
The computer 1 controls the test flow, configures the hardware environment, sends the test instruction, acquires the test parameters, judges and stores the test result.
Specifically, the computer 1 is connected to the test board 5 and the in-vivo simulation device 8, respectively. Detecting the charging function of the object 6 requires configuring a power source, for example, the power source 2 or the battery simulator 3 may be used. The power supply 2 is connected to the test board 5, and in this embodiment, the object 6 to be tested charges the in-vivo simulation device 8 by using the electric energy provided by the power supply 2, and the in-vivo simulation device 8 is configured with an independent battery as its power supply. The computer 1 can be connected with the test board 5 through a serial port or a network cable interface, and controls the tested object 6 to wirelessly charge the in-vivo simulation equipment 8 through the induction coil 7. The computer 1 acquires the charging parameters of the object 6 and the in-vivo simulation device 8, and accordingly judges whether the charging function of the object is normal.
The test fixture can change the relative positions of the in-vivo simulation equipment 8 and the induction coil 7 at any time, and the change of the distance or the gesture between the two can influence the charging parameters of the in-vivo simulation equipment 8 and the charging parameters of the measured object 6. The charging parameters include, for example, a charging current, a charging voltage, and the like. The computer judges whether or not the charging function of the object 6 to be measured is normal by comparing the charging parameter from the in-vivo simulation device 8 (power receiver) with the parameter from the object 6 to be measured (power output).
As a preferred embodiment, the computer 1 acquires the charging parameters returned by the object 6 to be tested, including: charging gear, rectifying and filtering voltage and in-body battery voltage U 0 In-vivo charging current I 0 Working current I of measured object 1 Charging emission voltage U 1 And charging efficiency. Wherein U is 0 The battery voltage and I received by the object 6 and the in-vivo simulation device 8 at intervals 0 The object 6 communicates with the in-vivo simulation device 8 at intervals to receive a charging current, and the charging efficiency is calculated by the object 6 according to the above parameters.
The computer 1 acquires the charging parameters of the in-vivo simulation device 8, including: in vivo charging current I 0 ' in-vivo battery voltage U 0 '. The charging parameter acquisition modes of the in-vivo simulation device 8 are divided into two types: 1. the in-vivo charging current and in-vivo battery voltage (also can be power supply voltage) are directly collected through collecting equipment (a collecting card, a power supply, an ammeter, a battery simulator and the like); 2. the in-vivo simulation device 8 sends the information to the tested object 6 in a wireless communication mode, and then sends the information to the computer in a mode of the tested board 5, bluetooth, wifi and the like. The data acquired in the two modes can be adopted as parameters and participate in judgment.
The computer 1 performs an operation including the following to determine whether the charging function of the object 6 is normal:
A. judging whether the rectified and filtered voltage is within a preset range, if not, judging that all charging parameters returned by the tested object 6 are not available, and if so, judging that the charging process is abnormal;
B. judging the in-vivo battery voltage U returned by the measured object 6 0 And the in-vivo battery voltage U acquired from the in-vivo simulation device 8 0 Whether the difference delta U is consistent or not is judged, if the difference delta U is not within the preset range, the charging process is judged to be abnormal;
C. judging in-vivo charging current I 0 And in-vivo charging current I 0 ' whether or not it corresponds to the expected value corresponding to the current charging range. Specifically, the expected value of the charging current value is different in different charging ranges, For example, when charging in 4 th gear, the corresponding expected current value is about 40ma±10%. If I 0 And I 0 Any one of the's' does not conform to the expected value, it is determined that there is an abnormality in the charging process;
D. determining in-vivo charging current I returned from object 6 0 And an in-vivo charging current I acquired from the in-vivo simulation device 8 0 Whether the difference delta I is consistent or not is judged, for example, whether the difference delta I between the two is within a preset range or not is judged, and if the difference delta I is not within the preset range, the charging process is judged to be abnormal;
E. by using the working current I of the measured object 1 And a charging emission voltage U 1 Calculating the charge emission power P1, and using the in-vivo battery voltage U returned by the object 6 0 And in-vivo charging current I 0 The charge received power P0 is calculated by using the in-vivo charge current I acquired from the in-vivo simulation device 8 0 ' and in-vivo Battery Voltage U 0 'calculating charge receiving power P0', calculating charge efficiency according to P1, P0 and P0', comparing the charge efficiency with the charge efficiency returned by the measured object, calculating errors of the charge receiving power P0, P0 and P0', judging whether the errors are in a set range, namely, comparing the charge efficiency returned by the measured object 6 with the charge efficiency obtained by actual calculation, and judging that the charge process is abnormal if the charge efficiency is inconsistent.
The above A must be performed first, B-E may be selectively performed or may be performed entirely, and the order of execution may be set.
The test system provided by the invention utilizes the simulation equipment to simulate the implanted medical device, utilizes the induction coil to simulate the coil of the external control equipment, and utilizes the computer to control the tested object to perform wireless charging on the simulation equipment through the induction coil, so that the tested object is in an actual working environment, wherein the relative position of the simulation equipment and the induction coil can be changed by utilizing the displacement platform, so as to simulate the charging operation possibly occurring in the actual use process of a user, the computer is used for controlling the charging process and reading the charging parameters of the tested object and the simulation equipment, and thus, whether the wireless charging function of the tested object is normal or not is detected.
In a preferred embodiment, the computer 1 controls the test fixture to set a plurality of said relative positions, and controls the object under test 6 to charge the in-vivo simulation device 8 in the plurality of relative positions. Specifically, for example, four distance values X1 … … X4 and a charging time t may be preset, so that wireless charging is performed at the four distances, respectively, for the duration t.
Further, the relative positions include relative distances and relative poses. For example, two postures are preset, and on each distance value, the computer 1 adjusts the induction coil 7 and the in-vivo simulation device 8 to take two postures to respectively charge for a duration t, namely, eight times of wireless charging are carried out, so that the charging parameters in each charging are obtained. There are various alternatives to the relative pose, such as parallel and aligned induction coil 7 with in-vivo simulation device 8, misalignment of induction coil 7 with in-vivo simulation device 8, alignment but non-parallel of induction coil 7 with in-vivo simulation device 8, etc., for simulating the pose that may occur when a user uses an in-vitro control device to wirelessly charge an in-vivo implant device.
Further, the computer 1 is configured to set a charging gear of the object 6, so that the object 6 uses a plurality of charging gears to charge the in-vivo simulation device 8, where different charging gears refer to different values of the charging voltage and/or the charging current. In combination with the above relative distance and relative posture, for example, four charging gears are preset, a specific charging test procedure is as follows:
the computer 1 adjusts the relative distance between the induction coil 7 and the in-vivo simulation device 8 to be X1, sets the relative distance to be a first gesture, sequentially adopts a first charging gear … … and a fourth charging gear to carry out wireless charging, respectively lasts for a time t, then sets the relative distance to be a second gesture, sequentially adopts a first charging gear … … and the fourth charging gear to carry out wireless charging, respectively lasts for a time t;
the computer 1 adjusts the relative distance between the induction coil 7 and the in-vivo simulation device 8 to be X2, sets the relative distance to be a first gesture, sequentially adopts a first charging gear … … and a fourth charging gear to carry out wireless charging, respectively lasts for a time t, then sets the relative distance to be a second gesture, sequentially adopts a first charging gear … … and the fourth charging gear to carry out wireless charging, respectively lasts for a time t;
therefore, various combinations of two relative postures and four charging gears are adopted on four relative distances to conduct wireless charging, and the charging parameters of 32 times of wireless charging are obtained. For the charging parameters of each wireless charging, the computer 1 determines whether the charging function of the object 6 is normal according to the above manner.
In an alternative embodiment, as shown in fig. 4 and 5, the test board 5 is provided with an NTC load configuration unit for simulating the resistance change of a thermistor (NTC), which includes a resistor network and a simulation switch combination, and is used for simulating the resistance change of the thermistor caused by the temperature change in the charging process to the object 6. The computer 1 configures the resistor network through the main control unit 16 on the test circuit board 5 to simulate the resistance change of the thermistor. By way of example: the main control unit 16 receives the instruction of the computer 1, adjusts the channel communication condition of the analog switch combination in the NTC load configuration 17, each channel is respectively connected with a resistor, and different channel selections can generate different resistor serial-parallel combination conditions, so that the resistance change is realized. The computer 1 adjusts the value of the resistor network to simulate the temperature change, and obtains a feedback signal (coil temperature) of the measured object 6 for the temperature change, so as to judge whether the over-temperature protection function of the measured object is normal. This detection operation may be performed during the above-described detection of the wireless charging function, or may be performed separately.
The measured object 6 is subjected to wireless charging in practical application, so that the metal shell of the in-vivo implantation device generates heat, the measured object 6 has overheat protection function, namely various countermeasures are required when the temperature indicated by the feedback signal is greater than the temperature threshold value, at least the phenomenon can be monitored, a resistance network is added into the test board 5 of the test system, the resistance value when the temperature of the thermistor is changed is simulated, and whether the overheat protection function of the measured object is normal can be detected in a targeted manner.
In an alternative embodiment, the system is configured to include a power supply 2 and a battery simulator 3, and the power supply 2 and the battery simulator 3 are respectively connected to the test board 5, and the computer 1 is configured to control the object 6 to charge the battery simulator 3 by using the electric energy provided by the power supply 2, and obtain the working parameters of the object 6 and the battery simulator 3, so as to determine whether the charging function of the object is normal.
The object 6 to be measured is also provided with a battery in practical use, and can be charged. In order to make the charging test targeted, the object 6 itself does not include a battery in the present system. In order to detect the self-charging function, the present embodiment adopts the battery simulator 3 as the battery of the object 6 to be tested, the computer 1 controls the battery simulator 3 to be charged by using the power supply 2, and the working parameters are read through the circuit table 11, so as to judge whether the self-charging function is normal.
The embodiment of the invention provides a test system of an external electromagnetic induction coil for an implantable medical instrument, which can be used for detecting the external electromagnetic induction coil for realizing charging and communication functions for rechargeable implantable medical instruments such as DBS (deep brain stimulation ), VNS (vagusneve stimulation, vagus nerve stimulation), SCS (Spinal cord stimulation, spinal cord electrical stimulation) and SNM (Sacral Neuromodulation, sacral nerve stimulation system).
Fig. 6 shows a schematic diagram of an induction coil structure, in which the coils to be measured are a communication coil 71 and a charging coil 72 equipped with a ferrite core 70. It should be noted that the present system is not limited to testing the coil shown in fig. 6, and other configurations or single communication coil or charging coil may be used.
As shown in fig. 7, the electromagnetic induction coil test system includes: computer 1, power 2 and test fixture. The test fixture is provided with an implantable medical instrument body simulation device 8, an external simulation device 23 and an induction coil 7 (a tested coil), and is used for adjusting the relative positions of the body simulation device 8 and the induction coil 7.
Regarding the in-vitro simulation device 23, reference may be made to the system in the above embodiment, for example, an in-vitro control device or a circuit board thereof that has been subjected to test may be used, in combination with the test board 5 as the in-vitro simulation device 23; an in vitro simulation device dedicated to testing the induction coil can also be designed.
The computer 1 is used for controlling the external simulation device 23 to charge the internal simulation device 8 through the induction coil 7, so as to obtain the charging parameters of the internal simulation device 8 and/or the external simulation device 23, and judging whether the induction coil 7 is normal or not according to the charging condition. Regarding the control operation of charging and the determination method of the charging parameter, reference may be made to the charging test system and the determination method in the above-described embodiments, in which the induction coil 7 is the subject of determination in the present embodiment, for example, when the charging parameter is abnormal, the conclusion is that the state of the induction coil 7 is abnormal.
The computer 1 is further used for controlling communication between the external simulation device 23 and the internal simulation device 8 through the induction coil, for example, the sending and executing conditions of the instruction can be obtained, and whether the induction coil 7 is normal or not is judged according to the communication conditions. Regarding the control operation of the communication, and the determination manner of the communication condition, reference may be made to the instruction test system and the determination manner in the above-described embodiments, except that in the present embodiment, the induction coil 7 is taken as the determination object, for example, when the external simulation device 23 sends a setting instruction regarding the stimulation parameter to the internal simulation device 8, and when the internal simulation device 8 does not perform the corresponding action, the conclusion is that the state of the induction coil 7 is abnormal.
For the induction coil test system, one main difference from the above-described charge test and instruction test system is that the system is provided with an impedance test device 18 (LCR meter) connected to the external simulation device 23 and the computer 1 for measuring the inductance and resistance of the induction coil 7. The computer 1 can obtain the inductance value and the resistance value, and compare the inductance value and the resistance value with the set parameters to judge whether the induction coil 7 is normal or not. The aim is to confirm whether the series inductance value Ls and the series resistance value Rs of the electromagnetic induction coil meet the use requirement; and confirming the parameter range of the ferrite core after being arranged in the electromagnetic induction coil, so that the test system is convenient for carrying out data statistical analysis related to the reliability of the electromagnetic coil.
In a specific embodiment, the induction coil 7 is connected to the test board 5, wherein the communication coil and the charging coil are electrically connected to the corresponding circuit structures, respectively. In the circuit structure that the test probe of the impedance test equipment 18 is connected to the test board 5, the main control unit 16 on the test board 5 utilizes the singlechip and the analog switch to realize the electric connection of the impedance test equipment probe and the communication coil or the charging coil respectively, the impedance test equipment 18 is connected with the computer 1 in a wired connection mode such as a serial port, and the like, receives the control command of the computer 1 and feeds back the test parameters.
The two coils are respectively measured to obtain two groups of data, namely the resistance value and the inductance value of the communication coil and the resistance value and the inductance value of the charging coil, and the computer 1 can respectively judge whether the two coils meet the use requirements.
For electromagnetic induction coils equipped with thermistors, the system can be used to measure whether the assembly of the thermistor is normal and whether the condition is normal, in particular two alternative embodiments.
As a first alternative, a resistor network for simulating a change in the resistance value of the thermistor is provided in the in-vivo simulation device 8. As shown in fig. 4 and 5, a resistor network is provided in the test board 5. The computer 1 controls a plurality of resistors in the resistor network to be sequentially connected with the thermistor in the tested coil and applies a fixed voltage V CC . The external simulation device 23 can collect the voltage value V of the thermistor NTC And calculates the thermistor value R as follows NTC ：
Wherein R is the resistance of a resistor network connected with the thermistor, R is different when different resistors are connected, for example, R is calculated when the resistor 1 is connected NTC1 … … R is calculated when the resistor N is connected NTCN . The computer 1 is used for acquiring the calculated thermistor values so as to judge whether the thermistor is normal or not.
Specifically, the computer 1 judges whether each thermistor value is consistent with a preset value, and in this scheme, the consistency may be within a certain error range;
when the thermistor values are consistent and consistent with the preset values, judging that the thermistor is normal in state and normal in assembly;
when the thermistor values are consistent but inconsistent with the preset values, judging that the thermistor is normally assembled and the state of the thermistor is abnormal (not in accordance with the use standard);
when the thermistor values are not uniform, it is determined that the thermistor assembly is abnormal.
As a second alternative, the test system is provided with an environment simulation device 19, at least for setting a temperature, and pressure and humidity can be set according to requirements to simulate the working environment temperature of the tested coil, and the induction coil 7 is placed in the environment simulation device 19. The temperature of the environmental simulation device 19 can be adjusted to T by the computer 1 1 ,T 2 ……T n The external simulation device measures temperature values at a plurality of set temperatures through the thermistor, and records the temperature value T measured by the external control device 6 when the temperatures are stable respectively 1 ’,T 2 ’……T n ’。
The computer obtains a plurality of measured temperature values and calculates an error delta T with the set temperature, such as:
thereby T can be obtained 1 And T is 1 ' error DeltaT 1 … … T n And T is n 'error Δtn', when each error is within the set range, determining that the thermistor is normal; otherwise, it is determined that the thermistor has a problem (or that the assembly is unsuccessful or that the device itself has a defect) and the test fails.
In addition, whether the thermistor is normal or not can be judged by the over-temperature protection function of the in-vitro simulation device 23. Specifically, the environment simulation device 19 is configured to gradually increase the set temperature, the external simulation device 23 measures the temperature value by the thermistor, and upon increasing to the highest set temperature, the computer 1 determines whether the external simulation device performs an overheat protection action, and if the overheat protection action is performed, determines that the thermistor is normal.
Further, whether the measurement accuracy of the thermistor meets the requirement can be judged through temperature rise and temperature reduction. Specifically, the environmental simulation device 19 is configured to gradually increase the set temperature and then gradually decrease the set temperature. During the temperature rising process, the computer 1 draws a temperature rising curve according to the temperature value measured by the external simulation device 23 through the thermistor (the abscissa is the temperature of the environment simulation device 19, and the ordinate is the temperature measured by the external simulation device 23); in the cooling process, the computer 1 draws a cooling curve according to the temperature value measured by the external simulation device 23 through the thermistor, calculates return error data (namely, the maximum deviation of the two curves) by using the heating curve and the cooling curve, and judges whether the measurement accuracy of the thermistor is required to be applied according to the return error data. If the return difference meets the requirement, judging that the thermistor in the electromagnetic induction coil operates normally, and if the return difference meets the requirement, judging that the device has defects or hidden troubles in assembly and the test fails.
As shown in fig. 8 and 9, an embodiment of the present application provides an automated testing tool for an external control device for an implantable medical device, including:
the in-vivo equipment tool 80 comprises an in-vivo simulation equipment mounting frame 81 and in-vivo simulation equipment 8 which is arranged on the in-vivo simulation equipment mounting frame 81 and is used for simulating an implantable medical device of a human body, wherein the in-vivo simulation equipment 8 is connected with the computer 1;
the external equipment fixture 4 comprises a first mounting groove 60 for mounting a tested object 6 (external control equipment or a circuit board thereof) and a second mounting groove 73 for mounting an induction coil 7, wherein the induction coil 7 is arranged opposite to the internal simulation equipment 8;
the multi-degree-of-freedom displacement platform 12, the in-vivo equipment tool 80 is movably arranged on the multi-degree-of-freedom displacement platform 12, and the multi-degree-of-freedom displacement platform 12 drives the in-vivo equipment tool 80 to move so as to change the relative position and/or the relative posture between the in-vivo simulation equipment 8 and the induction coil 7;
the test circuit board 5 is connected with the computer 1 and the induction coil 7 respectively, the first mounting groove 60 is arranged on the test circuit board 5, and the test circuit board 5 is connected with the tested object 6 (the external control equipment or the circuit board thereof) arranged on the first mounting groove 60 through the first mounting groove 60.
Specifically, the automated test tool provided by the embodiment of the application can automatically test the object 6 (the external control device or the circuit board thereof) serving as the object to be tested, when in test, the coil of the external control device is simulated by using the induction coil 7, so that the object 6 (the external control device or the circuit board thereof) to be tested is in an actual working environment, meanwhile, the relative positions of the internal simulation device 8 and the induction coil 7 are changed by using the multi-degree-of-freedom displacement platform 12, and the process of matching the internal simulation device 8 through the induction coil 7 is performed, so that the control operation of the external control device on the human body implantable medical device, which possibly occurs in the actual use process, of a user is simulated, and the purpose of realizing the automated operation in the whole test process is realized, and the automated test tool has higher working efficiency.
In addition, the automatic test fixture provided by the embodiment of the application can also be used for automatically testing the coil of the external control equipment serving as the tested object, namely the induction coil 7. During testing, the object 6 (the external control device or a circuit board thereof) or the simulation device of the external control device is used as a test tool, so that the induction coil 7 is in an actual working environment, meanwhile, the multi-degree-of-freedom displacement platform 12 is used for changing the relative positions of the internal simulation device 8 and the induction coil 7, and the induction coil 7 is matched with the internal simulation device 8 in the process, the internal simulation device 8 is charged and communicated through the induction coil 7, and the control operation of charging and the judgment mode of charging parameters are carried out, in particular to the method that the computer 1 is used for controlling the external control device and the circuit board 6 thereof to charge the internal simulation device 8 through the induction coil 7, so as to further obtain the charging parameters of the internal simulation device 8 and/or the external control device, judge whether the induction coil 7 is normal or not according to the charging condition, for example, the sending and executing condition of instructions can be obtained, and whether the induction coil 7 is normal or not is judged according to the communication condition, so that the control operation of the external control device to the human body implantation medical device possibly occurs in the actual use process through the external control device by a user is simulated through the structure, the computer 1 is further realizing the whole testing process with higher efficiency. Therefore, the technical problem of how to automatically test the controlled equipment in the related technology is solved.
Further, in the embodiment of the present application, the multi-degree-of-freedom displacement platform 12 is a triaxial displacement platform, which includes a first driving rail 121, a second driving rail 122 and a third driving rail 123, the second driving rail 122 is installed on the first driving rail 121, the third driving rail 123 is installed on the second driving rail 122, and the in-vivo simulation device mounting rack 81 is installed on the third driving rail 123, where the directions in which the first driving rail 121, the second driving rail 122 and the third driving rail 123 respectively drive the in-vivo simulation device 8 to move are different.
Specifically, the in-vivo simulation device 8 may be driven by the first driving rail 121, the second driving rail 122 and the third driving rail 123, so that the in-vivo simulation device 8 moves along the driving rail direction, thereby realizing the multiple degree of freedom movement of the in-vivo simulation device 8, where, optionally, the directions in which the first driving rail 121, the second driving rail 122 and the third driving rail 123 respectively drive the in-vivo simulation device 8 to move are perpendicular for the convenience of the operation of the multiple degree of freedom displacement platform 12 and the larger displacement space.
The multi-degree-of-freedom displacement platform 12 provided in the present application may be an XYZ three-axis displacement platform, and the first driving rail 121, the second driving rail 122, and the third driving rail 123 may respectively serve as XYZ axes.
In addition, the multi-degree-of-freedom displacement platform 12 may adopt a mechanical arm structure in some embodiments, and through the multi-degree-of-freedom displacement platform 12, not only the relative position between the in-vivo simulation device 8 and the induction coil 7, but also the relative posture between the in-vivo simulation device 8 and the induction coil 7 can be changed, so that various relative positions and relative postures between the in-vitro control device and the human body implantable medical device in the practical application process are simulated.
Optionally, the test circuit board 5 is parallel and fixedly arranged on the support plate 21, and the object 6 to be tested (the external control device or the circuit board thereof) is vertically inserted into the first mounting groove 60 of the test circuit board 5.
Specifically, the support plate 21 is used for carrying the test circuit board 5 and the extracorporeal equipment fixture 4, and the induction coil fixture 74 is used for installing the induction coil 7. Since the test circuit board 5 does not need to be replaced during the test, the test circuit board 5 is mounted on the support plate 21 in a state parallel to the support plate 21 for mounting stability. Since the object 6 to be tested (the external control device or the circuit board thereof) is plugged onto the test circuit board 5 and needs to be replaced frequently, the object 6 to be tested (the external control device or the circuit board thereof) is plugged onto the first mounting groove 60 in a vertical state for facilitating the mounting and the dismounting.
Alternatively, the induction coil fixture 74 is vertically and fixedly disposed on the support plate 21, the second mounting slot 73 is disposed on the induction coil fixture 74, and the induction coil fixture 74 and the induction coil 7 are vertically disposed with the object 6 to be measured (the external control device or the circuit board thereof).
Specifically, the support plate 21 is further used for carrying the induction coil fixture 74, and the second mounting slot 73 is disposed on the induction coil fixture 74, that is, the induction coil 7 is mounted on the induction coil fixture 74 through the second mounting slot 73. The induction coil fixture 74 and the induction coil 7 are vertically arranged with the object 6 to be tested (the external control device or the circuit board thereof), so that the induction coil 7 and the internal simulation device 8 can be oppositely arranged.
Alternatively, the induction coil tooling 74 is a structure made of an insulating material.
Specifically, the induction coil fixture 74 is an insulating plate, and the second installation slot 73 is disposed on an end surface of the insulating plate, which is close to the in-vivo simulation device 8.
Specifically, the induction coil 7 may be possibly interfered by other metal components, such as the test circuit board 5, during the working process, so that the induction coil 7 may be isolated by setting the insulating board, and the induction coil fixture 74 is vertically arranged, and the second mounting slot 73 is arranged on the end surface of the induction coil fixture 74 close to the in-vivo simulation device 8, so that the induction coil 7 mounted on the second mounting slot 73 may be matched with the in-vivo simulation device 8.
The second mounting groove 73 may be a groove disposed on the insulating plate, and an opening direction of the groove faces the multi-degree of freedom displacement platform 12.
Optionally, the material of the insulating plate comprises a non-metallic material.
Optionally, the induction coil tooling 74 is blocked between the test circuit board 5 and the second mounting slot 73.
Specifically, some components may be present on the test circuit board 5, which may interfere with the induction coil 7, and thus may be blocked between the test circuit board 5 and the second mounting slot 73 by an insulating plate.
Optionally, a third mounting slot is provided on the support plate 21, in which the test circuit board 5 is mounted horizontally.
Specifically, the test circuit board 5 may be positioned and fixedly mounted on the support plate 21 through the third mounting slot.
Optionally, the multi-degree of freedom displacement platform 12 further comprises a support platform 20, wherein the support platform 20 is arranged on one side of the multi-degree of freedom displacement platform 12, a guide groove 22 is formed in the support platform 20, and the support plate 21 is movably arranged on the guide groove 22.
Specifically, the support plate 21 is mounted on the guide groove 22 of the support table 20, so that the support plate 21 can slide on the guide groove 22, thereby changing the relative position and/or the relative posture between the second mounting groove 73 and the in-vivo simulation device 8.
Alternatively, the direction of movement of the support plate 21 over the guide slot 22 is parallel to the direction of movement of the in vivo simulation device 8 over one degree of freedom comprised by the multiple degree of freedom displacement platform 12.
Wherein, in order to facilitate the adjustment of the initial position between the second mounting groove 73 and the in-vivo simulation device 8, or the manual quantitative adjustment of the position between the second mounting groove 73 and the in-vivo simulation device 8, the guide of the guide groove 22 may be parallel to the first driving guide rail 121 as the X-axis.
It should be noted that, in order to prevent the test circuit board 5, the object to be tested 6 (the external control device or the circuit board thereof), etc. from interfering with the induction coil 7, the test board 5 and the first test slot 60 should be far away from the second test slot 70 as much as possible, but in consideration of reducing the occupied space, the test board 5, the object to be tested 66 and the induction coil 7 may be arranged in a distributed manner, for example, in a triangular arrangement, which may be specifically arranged according to actual needs by those skilled in the art.
Optionally, the in-vivo simulation device mounting rack 81 is provided with an arc-shaped groove corresponding to the in-vivo simulation device 8, and the in-vivo simulation device 8 is mounted in the arc-shaped groove to enable rotational inclination within a set angle range.
Specifically, the in-vivo simulation device mounting rack 81 is provided with an arc-shaped groove corresponding to the in-vivo simulation device 8, so that the in-vivo simulation device 8 can be mounted in the arc-shaped groove to perform rotation and inclination within a set angle range, and the spatial posture of the in-vivo simulation device 8 in a human body is simulated.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.
Claims (10)
1. An instruction testing system of an extracorporeal control apparatus for an implantable medical apparatus, comprising:
test fixture and computer;
the test fixture is provided with implantable medical instrument simulation equipment, an induction coil and a test board, and is used for changing the relative positions of the simulation equipment and the induction coil;
the test board is provided with an interface for connecting a tested object and the induction coil, the tested object is an external control equipment complete machine, the interface for connecting the tested object is set to be a universal interface, and the interface for updating program reservation on the external control equipment complete machine is connected with the interface through a switching device;
the computer is respectively connected with the test board and the simulation equipment and is used for controlling the tested object to send a control instruction to the simulation equipment through the induction coil so as to enable the simulation equipment to execute actions corresponding to the control instruction, obtain action execution results fed back by the simulation equipment, and determine whether the function of the tested object for sending the control instruction is normal or not by determining whether the instruction sending and the execution are consistent or not and determine whether the execution determination function of the feedback of the tested object is normal or not by determining the actual instruction execution condition.
2. The system of claim 1, wherein the computer is configured to control the test fixture to change the relative position and to control the object under test to send control instructions to the simulation device via the induction coil at a plurality of relative positions.
3. The system according to claim 2, wherein the computer determines the action execution result and the instruction transmission result at each relative position, and controls the test fixture to set the simulation device and the induction coil at a preset relative position after confirming the normality.
4. The system of claim 1, wherein the control instructions are configured to change a parameter of the analog device output stimulation signal.
5. The system of claim 4, further comprising an acquisition card for acquiring the stimulation signal output by the analog device; the computer determines the action execution result by acquiring the stimulus signal.
6. The system of claim 1, wherein the control instructions are configured to cause the simulation device to send status information to an object under test; the computer is used for reading the state information of the simulation equipment and acquiring the state information received by the tested object.
7. The system of claim 1, wherein the control instructions are for causing the analog device to turn on or off a functional module therein; the computer is used for acquiring the state information of the functional module.
8. The system of claim 1, wherein the test object is a circuit board; the circuit board comprises a base part and a tested part, wherein the tested part is a circuit board of an in-vitro control device;
the base is provided with a through hole for accommodating the tested part, and the edge of the tested part is connected with the edge of the through hole through a plurality of cuttable parts;
and one end of the base is provided with a plurality of interfaces for connecting the test board, and the interfaces are connected with the connection points on the tested part through wires arranged in the base and the tested part.
9. The system of claim 1, wherein the test board is provided with a wireless communication module, and the computer is wirelessly connected with the object to be tested through the wireless communication module.
10. The system of claim 1, wherein the computer is further configured to obtain a wireless communication signal strength of the test object.
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