CN112987698A

CN112987698A - Charging test method and device of external control device for implanted medical instrument

Info

Publication number: CN112987698A
Application number: CN202110352743.5A
Authority: CN
Inventors: 李冰; 王伟明; 艾飞; 李路明
Original assignee: Tsinghua University; Beijing Pins Medical Co Ltd
Current assignee: Tsinghua University; Beijing Pins Medical Co Ltd
Priority date: 2021-03-31
Filing date: 2021-03-31
Publication date: 2021-06-18
Anticipated expiration: 2041-03-31

Abstract

The invention provides a charging test method and equipment of in-vitro control equipment for an implantable medical instrument, which comprises the following steps: controlling the in-vitro control equipment to wirelessly charge the analog equipment; collecting charging parameters of the in-vitro control equipment, wherein the charging parameters comprise the charging parameters of the in-vitro control equipment and the charging parameters of the simulation equipment received by the in-vitro control equipment in a wireless communication mode; collecting charging parameters of analog equipment; and analyzing, calculating and comparing the charging parameters of the in-vitro control equipment and the charging parameters of the simulation equipment to judge whether the charging function of the in-vitro control equipment is normal.

Description

Charging test method and device of external control device for implanted medical instrument

Technical Field

The invention relates to the technical field of medical equipment detection, in particular to a charging test method and device of an external control device for an implantable medical instrument.

Background

An Implantable Medical Device (IMD) is a Medical apparatus installed inside the body of a user, and the IMD has a battery, a circuit board (provided with sensors, chips, etc.), and implements corresponding therapy depending on a set program and operating parameters, which may be set differently according to the condition of the user. Because the etiology and disease conditions of users are different, implantable medical devices installed in different users generally have different operating states, which are represented by battery voltage, operating time, power, current magnitude, frequency, and the like of the implantable medical devices.

The extracorporeal control apparatus is used in conjunction with an implantable medical device for adjusting the operational state of the implantable medical device to meet the therapeutic needs of the user. In order to ensure the stability and the safety of the in-vitro control equipment, the in-vitro control equipment generally needs to be comprehensively detected, the whole machine is manually detected in the conventional scheme, the efficiency of the detection mode is low, the in-vitro control equipment is closely related to the active implanted medical equipment, the active implanted medical equipment needs to be added in the detection process, the detection operation difficulty is high, the whole machine of the monitored control equipment comprises a circuit board, a battery, an electromagnetic induction coil and other parts, and the pertinence of the detection process needs to be improved.

Disclosure of Invention

In view of this, the present invention provides a charging test method for an in-vitro control device for an implantable medical device, including:

controlling the in-vitro control equipment to wirelessly charge the analog equipment;

collecting charging parameters of the in-vitro control equipment, wherein the charging parameters comprise the charging parameters of the in-vitro control equipment and the charging parameters of the simulation equipment received by the in-vitro control equipment in a wireless communication mode;

collecting charging parameters of analog equipment;

and analyzing, calculating and comparing the charging parameters of the in-vitro control equipment and the charging parameters of the simulation equipment to judge whether the charging function of the in-vitro control equipment is normal.

Optionally, the charging parameter of the extracorporeal control apparatus comprises a rectified and filtered voltage;

judging whether the charging function of the in-vitro control equipment is normal according to the charging parameters of the in-vitro control equipment and the charging parameters of the simulation equipment specifically comprises the following steps:

judging whether the rectified and filtered voltage is within a preset range or not;

when the rectified and filtered voltage is not in a preset range, judging that the charging function is abnormal;

and when the rectified and filtered voltage is within a preset range, judging whether the charging function of the external control equipment is normal or not according to other charging parameters of the external control equipment and the charging parameters of the simulation equipment.

Optionally, the charging parameter of the extracorporeal control apparatus includes an internal battery voltage U received by the extracorporeal control apparatus in a wireless communication manner₀The charging parameter of the simulation equipment comprises the voltage U of the in-vivo battery₀’；

determine the voltage U of the battery in the body₀And the voltage U of the battery in the body₀' whether or not to be consistent;

when the voltage of the battery U in the body₀And the voltage U of the battery in the body₀When the two are not matched, the charging function is determined to be abnormal.

Optionally, the charging parameter of the extracorporeal control apparatus includes an intracorporeal charging current I received by the extracorporeal control apparatus through wireless communication₀The charging parameter of the analog equipment comprises in-vivo charging current I₀’；

determining in vivo charging current I₀And the in-vivo charging current I₀' whether or not to be consistent;

when the charging current I in the body₀And the in-vivo charging current I₀When the two are not matched, the charging function is determined to be abnormal.

Optionally, the charging parameter of the extracorporeal control apparatus includes an intracorporeal charging current I received by the extracorporeal control apparatus through wireless communication₀And charging gear information, wherein the charging parameters of the simulation equipment comprise in-vivo charging current I₀’；

determining in vivo charging current I₀And in-vivo charging current I₀Whether the charging gear information respectively accords with expected values corresponding to the charging gear information or not;

when the charging current I in the body₀And in-vivo charging current I₀When any one of the charging steps does not conform to the expected value corresponding to the charging step information, it is determined that the charging function is abnormal.

Optionally, the charging parameter of the extracorporeal control apparatus comprises its calculated charging efficiency;

calculating actual charging efficiency according to the charging parameters of the in-vitro control equipment and the charging parameters of the simulation equipment;

judging whether the charging efficiency calculated by the in-vitro control equipment is consistent with the actual charging efficiency;

and when the charging efficiency calculated by the in-vitro control equipment is inconsistent with the actual charging efficiency, judging that the charging function is abnormal.

Optionally, the charging parameter of the extracorporeal control apparatus comprises an operating current I₁Charging emission voltage U₁And its in-vivo charging current I received by wireless communication₀And the in-vivo battery voltage U₀The charging parameter of the analog equipment comprises in-vivo charging current I₀' and in vivo Battery Voltage U₀’；

Calculating the actual charging efficiency according to the charging parameters of the in-vitro control device and the charging parameters of the simulation device specifically comprises:

according to the working current I₁And a charging emission voltage U₁Calculating charging transmission power P1;

according to the voltage U of the in-vivo battery₀And in-vivo charging current I₀Calculating charging received power P0;

according to in vivo charging current I₀' and in vivo Battery Voltage U₀'calculating charging received power P0';

the actual charging efficiency was calculated from P1, P0, and P0'.

Optionally, in the process of controlling the in-vitro control device to wirelessly charge the analog device, simulating temperature change in the charging process through a resistance network; the charging parameter of the extracorporeal control apparatus comprises a coil temperature;

the method further comprises the following steps:

monitoring whether the in-vitro control equipment executes over-temperature protection action when the temperature of the coil exceeds a preset temperature;

and if the in-vitro control equipment does not execute the over-temperature protection action, judging that the over-temperature protection function is abnormal and the charging function is abnormal.

Correspondingly, the invention also provides a charging test device of the external control device for the implantable medical instrument, which comprises: at least one processor; and a memory communicatively coupled to the at least one processor; the memory stores instructions executable by the processor, and the instructions are executed by the at least one processor to cause the at least one processor to execute the charging test method of the external control device for the implantable medical device.

According to the test method and the test equipment provided by the invention, the in-vitro control equipment wirelessly charges the analog equipment through the induction coil, the charging parameters of the in-vitro control equipment, the charging parameters of the analog equipment received by the in-vitro control equipment in a wireless communication mode and the charging parameters of the analog equipment are collected in the charging process, and whether the wireless charging function of the in-vitro control equipment is normal or not is detected by analyzing, judging and comparing the three parameters.

Drawings

The features and advantages of the present invention will be more clearly understood by reference to the accompanying drawings, which are illustrative and not to be construed as limiting the invention in any way, and in which:

FIG. 1 is a schematic structural diagram of an instruction testing system according to an embodiment of the present invention;

FIG. 2 is a schematic structural diagram of a test circuit board and a circuit board under test according to an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a charging test system according to an embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a test circuit board according to an embodiment of the present 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 structural diagram of an induction coil according to an embodiment of the present invention;

FIG. 7 is a schematic structural diagram of an electromagnetic induction coil testing system in an embodiment of the present invention;

FIG. 8 is a schematic structural diagram of a test fixture in an embodiment of the present disclosure;

fig. 9 is a schematic structural diagram of another view angle of the test fixture in the embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Embodiments of the present invention provide a command testing system for an external control device of an implantable medical device, which may be used for an external controller of a charging and non-charging implantable medical device, such as DBS (deep brain stimulation), VNS (vagal stimulation), SCS (Spinal cord stimulation), and SNM (Sacral nerve stimulation). As shown in fig. 1, the system includes: computer 1, power 2 and test fixture. An implanted medical instrument simulation device (hereinafter referred to as simulation device or IPG)8, an induction coil 7 and a test board 5 are arranged on the test tool, and the test tool is used for adjusting the relative position of the in-vivo simulation device 8 and the induction coil 7.

The specific structure of the test fixture has various options, for example, the test fixture can be an electric device provided with one or more guide rails, and the in-vivo simulation device 8 and the induction coil 7 can be respectively placed on two platforms capable of realizing relative motion, so that the position change between the two platforms can be realized. The measured object in the embodiment of the present invention may be an extracorporeal control apparatus, or a circuit board of the apparatus). The induction coil 7 is part of the test system, and simulates a charging and communication coil of the extracorporeal control equipment; the internal simulation device 8 simulates an implanted medical instrument, and an induction coil is also arranged in the internal simulation device 8. The relative position may be a relative distance, and may also include a relative angle, and the like, depending on the structure of the test fixture, 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 to be tested 6 and the induction coil 7, and a control circuit, wherein the induction coil 7 is connected with the object to be tested 6 through the interface, and the control circuit is used for receiving and processing instructions of the computer 1, sending the instructions to the object to be tested 6, reading information in the instructions, controlling other elements on the test board 5, and the like. In one embodiment, the object to be tested 6 is an external control device complete machine, and in order to adapt to various types and models of external control devices, the interface connected with the object to be tested 6 is set as a universal interface and is connected with the interface used for updating the program reservation on the external control device through the adapter device.

In another embodiment, the object to be tested 6 is a circuit board of an extracorporeal control device. As shown in fig. 2, the circuit board connected to the test board 5 includes a base portion 61 and a portion to be tested 62, wherein the portion to be tested 62 is a circuit board of the 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 uniform interfaces 64 for connecting the test board 5, and the uniform interfaces 64 are connected to connection points on the part to be tested 62 through wires arranged in the base 61 and the part to be tested 62. The unified interface 64 may be a gold finger jack, a flat cable, or an air plug.

The base is surrounded all around to the portion of being surveyed of circuit board that this embodiment provided, when needs examine time, equipment such as operating personnel or manipulator can centre gripping base and peg graft to testing board, and the base is as actual atress object, can play better guard action to the portion of being surveyed, can follow the basal excision with the portion of being surveyed after accomplishing the detection for whole testing process safety and convenience.

The computer 1 controls the testing process, configures the hardware environment, sends the testing instruction, obtains the testing parameters, judges and stores the testing 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 source 2 is connected to the test board 5, which in this embodiment supplies 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 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 object to be tested 6 to send a control instruction to the in-vivo simulation device 8 through the induction coil 7, so that the in-vivo simulation device 8 executes an action 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 judgment result fed back by the object to be measured 6 through a wired connection mode such as a serial port and the like, determines whether the function of the object to be measured 6 for sending the control instruction is normal or not by judging whether the instruction sending and the execution are consistent or not, and determines whether the execution judgment function fed back by the object to be measured 6 is normal or not through the actual instruction execution condition.

Before the computer 1 controls the object to be tested 6 to send out a control command, the test tool is adjusted to make the induction coil 7 and the in-vivo simulation device 8 be in a static relative position. The relative position may be a preset fixed position, different fixed positions may be set according to the type or model of the object 6 to be measured, or a uniform fixed position.

The system can be used for testing various control instructions. In one embodiment, the control instructions are used to change the parameters of the in vivo simulation device 8 output stimulation signals. Specifically, the computer 1 sends control information to the object to be tested 6 via the test board 5, so that it sends an instruction to change the stimulation parameters, such as changing the stimulation frequency, amplitude, changing the electrodes outputting the stimulation signals, etc., to the in-vivo simulation device 8 via the induction coil 7. If the in-vivo simulation device 8 is able to receive control instructions and the content of the instructions is correct, a corresponding action should be performed, i.e. changing the above-mentioned stimulation parameters.

There are various methods for acquiring the action execution result fed back by the in-vivo simulation device 8 by the computer 1, and in this embodiment, the stimulation signal output by the in-vivo simulation device 8 is acquired by the signal acquisition card 9 and transmitted to the computer 1. The computer 1 determines the action execution result by judging the waveform of the stimulation signal, namely judging 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 output electrodes respectively, so that the computer 1 can determine which output electrode outputs the stimulation signal.

In another embodiment, the control instructions are adapted to cause the in-vivo simulation device 8 to send status information to the object 6 to be tested. Specifically, the computer 1 sends control information to the object to be tested 6 through the test board 5, so that the computer sends an instruction for feeding back status information, such as the current stimulation frequency, amplitude, electrode outputting stimulation signal, etc., to the in-vivo simulation device 8 through the induction coil 7. If the in-vivo simulation device 8 can receive the control instruction and the instruction content is correct, the corresponding action should be performed, i.e. the state of the device itself is fed back.

In this embodiment, the stimulation signal output by the in-vivo simulation device 8 is collected by the signal acquisition 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 object to be tested 6 by judging the waveform of the stimulation signal, namely, whether the signal frequency and the amplitude of the stimulation signal are consistent with the content indicated by the state information is judged 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 function module therein, such as a bluetooth communication module, a stimulation output module, or the like. Specifically, the computer 1 sends control information to the object to be tested 6 through the test board 5, so that the computer sends an instruction to turn on or off a certain function module, such as turning on or off bluetooth, turning on or off a stimulus output, and the like, 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 instruction and the instruction content is correct, the corresponding action should be performed. The computer 1 is configured to obtain state information of the corresponding functional module, for example, the computer 1 collects a current value of the in-vivo simulation device 8 at this time through an ammeter, a dc power supply, or an acquisition card, and if the current value is increased and is within an expected standard range, the computer may determine that the instruction for turning on the bluetooth 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 in-vitro control equipment, enables the object to be tested to be in the actual working environment, simultaneously utilizes the displacement platform to change the relative position of the simulation equipment and the induction coil so as to simulate the communication operation which possibly occurs in the actual use process of a user, controls the object to be tested to send an instruction to the simulation equipment through the computer, and obtains the execution condition of the simulation equipment on the instruction so as to determine whether the instruction sending function of the in-vitro 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, in the test process, the computer 1 controls the test tool to control the object to be tested 6 to send a control command to the in-vivo simulation device 8 through the induction coil 7 under a plurality of relative positions, for example, sending the control command at a shortest distance and sending the control command at a maximum distance. The computer 1 determines whether the instruction at each position is sent and executed in accordance with each other (referred to as a distance traversal test). After the normality is confirmed, that is, the instruction sending and executing conditions at each position are consistent, the test tool 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 object to be tested 6 is controlled to send an instruction to the in-vivo simulation device 8 through the induction coil 7 again, and whether the instruction sending and executing conditions are consistent or not is judged (called 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 distance traversal test can be adopted only for new products when the system is used for testing the first new product for the first time, so that the fact that the instructions are executable at all distances is determined, interference of distance factors on test results is eliminated, the distance traversal test can not be used when the same product is tested later, and only formal test is adopted.

In an optional embodiment, the test board 5 is provided with a wireless communication module, the computer 1 is wirelessly connected with the object to be tested 6 through the wireless communication module, and sends control information to the object to be tested 6 or reads status information therein through wireless communication modes such as WiFi, bluetooth, PPM, and the like. The object 6 to be tested is adjusted to the wireless communication state, and the computer 1 reads the signal intensity of the object 6 to be tested by using the wireless communication module to test whether the wireless communication function is normal.

An embodiment of the present invention provides a charging test system for an external control device of an implantable medical device, which may be used for an external controller of a charging implantable medical device, such as DBS (deep brain stimulation), VNS (vagal stimulation), SCS (Spinal cord stimulation), and SNM (Sacral neurostimulation). As shown in fig. 3, the system includes: computer 1, power 2, battery simulator 3 and test fixture. An implanted medical instrument simulation device (hereinafter referred to as simulation device or IPG)8, an induction coil 7 and a test board 5 are arranged on the test tool, and the test tool is used for adjusting the relative position of the in-vivo simulation device 8 and the induction coil 7.

Reference is made in detail to the above embodiments, and several alternative configurations provided below, with respect to the test fixture.

The test board 5 is provided with an interface for connecting the object to be tested 6 and the induction coil 7, and the induction coil 7 is connected with the object to be tested 6 through the interface. Similarly to the above embodiments, the object to be tested 6 may be the whole extracorporeal control apparatus or the circuit board thereof.

Specifically, the computer 1 is connected to the test board 5 and the in-vivo simulation device 8, respectively. The charging function of the object to be tested 6 requires the configuration of a power supply, for example, the power supply 2 or the battery simulator 3 can be used. The power source 2 is connected to the test board 5, and in this embodiment, the object to be tested 6 charges the in-vivo simulation device 8 by using the power supplied by the power source 2, and the in-vivo simulation device 8 is provided with a separate battery as its power source. The computer 1 can be connected with the test board 5 through a serial port or a network cable interface, and controls the object to be tested 6 to wirelessly charge the in-vivo simulation device 8 through the induction coil 7. The computer 1 obtains the charging parameters of the object to be measured 6 and the in-vivo simulation device 8, and accordingly judges whether the charging function of the object to be measured is normal.

The relative position of the in-vivo simulation equipment 8 and the induction coil 7 can be changed at any time by the test tool, and the change of the distance or the posture of the in-vivo simulation equipment 8 and the induction coil will influence the charging parameters of the in-vivo simulation equipment 8 and the charging parameters of the tested object 6. The charging parameters include, for example, a charging current, a charging voltage, and the like. The computer judges whether the charging function of the object to be measured 6 is normal by comparing the charging parameter from the in-vivo simulation device 8 (electric energy receiver) with the parameter from the object to be measured 6 (electric energy output side).

As a preferred embodiment, the computer 1 obtains the charging parameters returned by the object to be measured 6, including: charging gear, rectifying and filtering voltage and internal battery voltage U₀Internal charging current I₀The working current I of the object to be measured₁Charging emission voltage U₁And efficiency of charging. Wherein U is₀Is the battery voltage, I, received by the object 6 to be tested communicating with the in-vivo simulation device 8 at intervals₀The charging current received by the object to be measured 6 communicating with the in-vivo simulation device 8 at intervals, the charging efficiency is calculated by the object to be measured 6 according to the parameters.

The computer 1 acquires the charging parameters of the in-vivo simulation device 8, and comprises the following steps: in vivo charging current I₀' in vivo battery voltage U₀'. The charging parameter acquisition modes of the in-vivo simulation device 8 are divided into two types: 1. the in-vivo charging current and the in-vivo battery voltage (also can be the power supply voltage) are directly collected through collection equipment (a collection card, a power supply, an ammeter, a battery simulator and the like); 2. the in-vivo simulation equipment 8 is sent to the measured object 6 in a wireless communication mode and then sent to the computer in a measured plate 5 or in a Bluetooth mode, a wifi mode and the like. The data acquired by the two methods can be respectively adopted and participate in judgment.

The computer 1 performs operations including the following to determine whether the charging function of the object under test 6 is normal:

A. judging whether the rectified and filtered voltage is in a preset range, and if not, judging that all charging parameters returned by the measured object 6 are unavailable and the charging process is abnormal;

B. the voltage U of the in-vivo battery returned by the measured object 6 is judged₀And the in-vivo battery voltage U collected from the in-vivo simulation device 8₀Whether the difference value delta U is consistent or not is judged, for example, whether the difference value delta U is in a preset range or not is judged, and if the difference value delta U is not in the preset range, the charging process is judged to be abnormal;

C. determining in vivo charging current I₀And in-vivo charging current I₀' whether the expected value corresponding to the current charging gear is met. Specifically, the expected value of the charging current is different in different charging gears, for example, when 4 gears are charged, the corresponding expected current value is about 40mA ± 10%. If I₀And I₀If any one of the charging processes is not in accordance with the expected value, judging that the charging process is abnormal;

D. judging the charging current I in the body returned by the measured object 6₀With the in vivo data collected from the in vivo simulation device 8Charging current I₀Whether the difference value delta I is consistent or not is judged, for example, whether the difference value delta I is within a preset range or not is judged, and if the difference value 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 object to be measured₁And a charging emission voltage U₁Calculating charging emission power P1, and using the voltage U of the battery in the body returned by the object 6 to be measured₀And in-vivo charging current I₀Calculating charging received power P0 using in-vivo charging current I collected from in-vivo simulation device 8₀' and in vivo Battery Voltage U₀The charging received power P0 'is calculated, the charging efficiency is calculated according to P1, P0 and P0', the charging efficiency is compared with the charging efficiency returned by the object to be measured, the error of the charging efficiency and the error is calculated, whether the error is within a set range or not is judged, namely whether the charging efficiency returned by the object to be measured 6 is consistent with the charging efficiency obtained through actual calculation or not is compared, and if the error is not consistent, the charging process is judged to be abnormal.

The above-mentioned a must be executed first, B-E may be executed selectively or may be executed entirely, and the execution order 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, controls the object to be tested to wirelessly charge the simulation equipment through the induction coil by the computer, enables the object to be tested to be in an actual working environment, utilizes the displacement platform to change the relative position of the simulation equipment and the induction coil so as to simulate the charging operation which possibly occurs in the actual use process of a user, controls the charging process through the computer, reads the charging parameters of the object to be tested and the simulation equipment, and detects whether the wireless charging function of the object to be tested is normal or not.

In a preferred embodiment, the computer 1 controls the testing tool to set a plurality of relative positions, and controls the object to be tested 6 to charge the in-vivo simulation device 8 at the plurality of relative positions. Specifically, for example, four distance values X1 … … X4 and the charging time t may be preset so that wireless charging is performed at the four distances for the duration t, respectively.

Further, the relative position includes a relative distance and a relative attitude. For example, two postures are preset, and at each distance value, the computer 1 adjusts the distance between the induction coil 7 and the in-vivo simulation device 8 to adopt the two postures to respectively perform charging duration time t, that is, eight times of wireless charging is performed, so that the charging parameter during each charging is obtained. There are many optional ways for the relative posture, such as the induction coil 7 is parallel to and aligned with the in-vivo simulation device 8, the induction coil 7 is misaligned with the in-vivo simulation device 8, the induction coil 7 is aligned with but not parallel to the in-vivo simulation device 8, and so on, for simulating the posture that may occur when the user wirelessly charges the in-vivo implanted device using the in-vitro control device.

Furthermore, the computer 1 is configured to set a charging gear of the object to be measured 6, so that the object to be measured 6 charges the in-vivo simulation device 8 using a plurality of charging gears, where different charging gears refer to different values of the charging voltage and/or the charging current. In combination with the above-mentioned relative distance and relative posture, for example, preset four charging gears, a specific charging test process is as follows:

the computer 1 adjusts the relative distance between the induction coil 7 and the in-vivo simulation equipment 8 to be X1, sets the posture to be a first posture, sequentially adopts a first charging gear … … and a fourth charging gear to carry out wireless charging for duration time t respectively, then sets the posture to be a second posture, sequentially adopts a first charging gear … … and a fourth charging gear to carry out wireless charging for duration time t respectively;

the computer 1 adjusts the relative distance between the induction coil 7 and the in-vivo simulation equipment 8 to be X2, sets the posture to be a first posture, sequentially adopts a first charging gear … … and a fourth charging gear to carry out wireless charging for duration time t respectively, then sets the posture to be a second posture, sequentially adopts a first charging gear … … and a fourth charging gear to carry out wireless charging for duration time t respectively;

therefore, wireless charging is carried out on four relative distances by adopting various combinations of two relative postures and four charging gears respectively, and the charging parameters of 32 times of wireless charging are obtained. And aiming at the charging parameters of each wireless charging, the computer 1 judges whether the charging function of the measured object 6 is normal or not according to the above modes.

In an alternative embodiment, as shown in fig. 4 and 5, the test board 5 is provided with an analog thermistor (NTC) load configuration unit for simulating the resistance variation of a NTC, which includes a combination of a resistor network and an analog switch, and is used for simulating the resistance variation of the NTC caused by the temperature variation during the charging process to the object 6 to be tested. 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 an instruction of the computer 1, adjusts the channel connection condition of the analog switch combination in the NTC load configuration 17, each channel is connected with a resistor, and different resistor series-parallel combination conditions can be generated by different channel selections, so that the resistance value change is realized. The computer 1 adjusts the value of the resistance 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 in the process of detecting the wireless charging function described above, or may be performed separately.

The tested object 6 is wirelessly charged in practical application to cause the metal shell of the implanted device to generate heat, the tested object 6 has an overheat protection function, namely, when the temperature indicated by the feedback signal is higher than a temperature threshold value, various measures should be taken, and at least the phenomenon can be monitored.

In an alternative embodiment, the system is configured to include both the power source 2 and the battery simulator 3, which are respectively connected to the test board 5, and the computer 1 is configured to control the object to be tested 6 to charge the battery simulator 3 using the electric energy provided by the power source 2, and obtain the operating parameters of the object to be tested 6 and the battery simulator 3, and accordingly determine whether the charging function of the object to be tested is normal.

The object to be measured 6 is also provided with a battery in practical use and can be charged. In order to make the charging test more targeted, the object under test 6 itself does not comprise a battery in the present system. In order to detect its own charging function, the present embodiment employs the battery simulator 3 as the battery of the object to be tested 6, the computer 1 controls it to charge the battery simulator 3 using the power supply 2, and reads the operating parameters through the circuit table 11, thereby determining whether its own 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 which realizes the charging and communication functions of rechargeable implantable medical instruments such as DBS (deep brain stimulation), VNS (vagnosne stimulation), SCS (Spinal cord stimulation), SNM (Sacral nerve stimulation) and the like.

Fig. 6 shows a schematic diagram of an induction coil structure, in this embodiment the coil to be measured is 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 of fig. 6, and that other configurations or testing of a single communication coil or charging coil are possible.

As shown in fig. 7, the electromagnetic induction coil testing system includes: computer 1, power 2 and test fixture. The test fixture is provided with an implanted medical instrument in-vivo simulation device 8, an in-vitro simulation device 23 and an induction coil 7 (tested coil), and is used for adjusting the relative position of the in-vivo simulation device 8 and the induction coil 7.

As for the in vitro simulation device 23, reference may be made to the system in the above embodiment, such as using a qualified in vitro control device or its circuit board, in combination with the test board 5 as the in vitro simulation device 23; in-vitro simulation equipment dedicated to testing induction coils can also be designed.

The computer 1 is used for controlling the in-vitro simulation device 23 to charge the in-vivo simulation device 8 through the induction coil 7, further acquiring charging parameters of the in-vivo simulation device 8 and/or the in-vitro 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 manner of determining the charging parameter, reference may be made to the charging test system and the determination manner in the above-described embodiment, except that the induction coil 7 is used as a determination target in the present embodiment, and for example, when the charging parameter is abnormal, it is concluded that the state of the induction coil 7 is abnormal.

The computer 1 is also used for controlling the communication between the in-vitro simulation device 23 and the in-vivo simulation device 8 through the induction coil, for example, command sending and execution conditions can be obtained, and whether the induction coil 7 is normal or not is judged according to the communication conditions. With regard to the control operation of communication and the manner of determination of the communication situation, reference may be made to the instruction testing system and the manner of determination in the above-described embodiment, except that in the present embodiment, the induction coil 7 is used as a determination target, and for example, when the in-vivo simulation device 8 does not perform a corresponding action while the in-vitro simulation device 23 sends a setting instruction regarding a stimulation parameter to the in-vivo simulation device 8, it is concluded that the state of the induction coil 7 is abnormal.

As for the induction coil test system, one of the main differences 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 in vitro simulation device 23 and the computer 1 for measuring the inductance value and the resistance value 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 purpose is to confirm whether the series inductance Ls and the series resistance Rs of the electromagnetic induction coil meet the use requirements or not; and the parameter range of the ferrite core after the ferrite core is arranged in the electromagnetic induction coil is confirmed, so that the test system can conveniently perform data statistical analysis related to the reliability of the electromagnetic coil.

In the exemplary 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. The test probe of the impedance test device 18 is connected to the circuit structure on the test board 5, the main control unit 16 on the test board 5 utilizes the single chip microcomputer and the analog switch to realize the electric connection of the impedance test device probe with the communication coil or the charging coil respectively, the impedance test device 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 sets 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 the electromagnetic induction coil equipped with the thermistor, the system can be used for measuring whether the assembly of the thermistor is normal or not and whether the state is normal or not, and particularly has two optional embodiments.

As a first alternative, the in-vivo simulation device 8 is provided with a resistor network for simulating the change of the resistance value of the thermistor. As shown in fig. 4 and 5, for example, 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 thermistors in the coil to be detected and applies a fixed voltage V_CC. The voltage value V of the thermistor can be acquired by the in-vitro simulation equipment 23_NTCAnd calculating the thermistor value R as follows_NTC：

Where R is the resistance of the resistor network to which the thermistor is connected, and R is different when different resistors are connected, e.g. R is calculated when resistor 1 is connected_NTC1… … calculating R when connecting resistance N_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 determines whether the thermistor values are consistent and consistent with preset values, in the present embodiment, the consistency may be within a certain error range;

when the thermistor values are consistent and consistent with preset values, judging that the state of the thermistor is normal and the assembly is normal;

when the thermistor values are consistent but not consistent with the preset values, judging that the assembly of the thermistor is normal and the self state is abnormal (not conforming to the use standard);

when the respective thermistor values are not in agreement, it is determined that the thermistor is assembled abnormally.

As a second alternative, an environment simulation device 19 is provided in the test system, at least for setting temperature, and also for setting pressure and humidity according to requirements, so as to simulate the temperature of the working environment in which the coil to be tested is located, and the induction coil 7 is placed in the environment simulation device 19. The temperature of the environment simulation device 19 can be adjusted to T by the computer 1₁,T₂……T_nThe external simulation equipment measures temperature values through the thermistor under a plurality of set temperatures, and respectively records the temperature value T measured by the external control equipment 6 when the temperature is stable₁’,T₂’……T_n’。

The computer obtains a plurality of measured temperature values and calculates an error Δ T from a set temperature, such as:

from which T can be obtained₁And T₁' error Δ T1 … … T_nAnd T_nWhen each error is within a set range, judging that the thermistor is normal; otherwise, the thermistor is judged to have problems (or the assembly is unsuccessful or the device has defects) and the test is not passed.

In addition, whether the thermistor is normal or not can be judged through the over-temperature protection function of the in-vitro simulation equipment 23. Specifically, the environment simulation apparatus 19 is configured to gradually increase the set temperature, the in-vitro simulation apparatus 23 measures the temperature value by the thermistor, and when the set temperature is increased to the maximum set temperature, the computer 1 determines whether the in-vitro simulation apparatus performs the over-temperature protection action, and if the over-temperature protection action is performed, determines that the thermistor is normal.

Furthermore, whether the measurement accuracy of the thermistor meets the requirement can be judged through temperature rise and temperature drop. Specifically, the environment simulation device 19 is configured to first gradually increase the set temperature and then gradually decrease the set temperature. In the temperature rise process, the computer 1 draws a temperature rise curve according to the temperature value measured by the in-vitro simulation equipment 23 through the thermistor (the abscissa is the temperature of the environment simulation equipment 19, and the ordinate is the temperature measured by the in-vitro simulation equipment 23); in the cooling process, the computer 1 draws a cooling curve according to the temperature value measured by the thermistor by the in-vitro simulation equipment 23, 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 meets the application requirement or not according to the return error data. If the return difference meets the requirement, the thermistor in the electromagnetic induction coil is judged to normally operate, and the measurement accuracy meets the requirement, otherwise, the device can be judged to have defects or hidden dangers in assembly, and the test cannot be passed.

As shown in fig. 8 and 9, an embodiment of the present application provides an automated testing tool for an extracorporeal control device for an implantable medical device, including:

the in-vivo equipment tool 80 comprises an in-vivo simulation equipment mounting rack 81, in-vivo simulation equipment 8 which is mounted on the in-vivo simulation equipment mounting rack 81 and used for simulating the human body implanted medical device, wherein the in-vivo simulation equipment 8 is connected with the computer 1;

the in-vitro equipment tool 4 comprises a first mounting slot 60 for mounting the measured object 6 (in-vitro control equipment or a circuit board thereof) and a second mounting slot 73 for mounting the induction coil 7, wherein the induction coil 7 is arranged opposite to the in-vivo simulation equipment 8;

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 respectively connected with the computer 1 and the induction coil 7, the first installation slot 60 is arranged on the test circuit board 5, and the test circuit board 5 is connected with a tested object 6 (an external control device or a circuit board thereof) installed at the first installation slot 60 through the first installation slot 60.

Specifically, the automated testing tool provided by the embodiment of the application can be used for automatically testing an object to be tested 6 (external control equipment or a circuit board thereof) serving as a tested object, during testing, the induction coil 7 is used for simulating a coil of the external control equipment, so that the tested object 6 (the external control equipment or the circuit board thereof) is in an actual working environment, meanwhile, the relative position of the internal simulation equipment 8 and the induction coil 7 is changed by using the multi-degree-of-freedom displacement platform 12, and the process of matching the internal simulation equipment 8 with the induction coil 7 is used for simulating the control operation of a user on the human body implanted medical device through the external control equipment in the actual use process, so that the purpose of realizing the automated operation in the whole testing process is realized, and the automated testing tool has high working efficiency.

In addition, the automatic testing tool provided by the embodiment of the application can be used for automatically testing the coil of the in-vitro control equipment serving as the tested object, namely the induction coil 7. During testing, the object to be tested 6 (external control equipment or a circuit board thereof) or simulation equipment of the external control equipment is used as a testing tool, the induction coil 7 is in an actual working environment, the relative position of the internal simulation equipment 8 and the induction coil 7 is changed by using the multi-degree-of-freedom displacement platform 12, the process of matching the internal simulation equipment 8 with the induction coil 7 is performed, the internal simulation equipment 8 is charged and communicated through the induction coil 7, the charging control operation and the charging parameter judgment mode are related, specifically, the computer 1 is used for controlling the external control equipment and the circuit board 6 thereof to charge the internal simulation equipment 8 through the induction coil 7, so as to obtain the charging parameters of the internal simulation equipment 8 and/or the external control equipment, and judge whether the induction coil 7 is normal according to the charging condition, and the computer 1 is also used for controlling the communication between the external control equipment and the internal simulation equipment 8 through the induction coil 7 For example, the instruction sending and executing conditions can be acquired, and whether the induction coil 7 is normal or not is judged according to the communication conditions, so that the control operation of the user on the human body implanted medical device through the in-vitro control equipment possibly occurring in the actual use process is simulated through the structure, the aim of realizing the automatic operation in the whole test process is further fulfilled, and the high working efficiency is achieved. Therefore, the technical problem of how to carry out automatic test on the tested control 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 three-axis displacement platform, and includes a first driving rail 121, a second driving rail 122, and a third driving rail 123, where 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 installation rack 81 is installed on the third driving rail 123, where 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 can be driven by the first driving guide rail 121, the second driving guide rail 122 and the third driving guide rail 123, so that the in-vivo simulation device 8 moves along the driving guide rail direction, thereby realizing multi-degree-of-freedom movement of the in-vivo simulation device 8, wherein optionally, for convenience of operation of the multi-degree-of-freedom displacement platform 12 and a larger displacement space, the directions in which the first driving guide rail 121, the second driving guide rail 122 and the third driving guide rail 123 respectively drive the in-vivo simulation device 8 to move are perpendicular to each other.

Here, the multi-degree-of-freedom displacement platform 12 provided by the present application may be an XYZ three-axis displacement platform, and the first drive rail 121, the second drive rail 122, and the third drive rail 123 may respectively serve as XYZ axes.

In addition, the multi-degree-of-freedom displacement platform 12 can adopt a structure of a mechanical arm in some embodiments, and the multi-degree-of-freedom displacement platform 12 can change the relative position between the in-vivo simulation device 8 and the induction coil 7, change the relative posture between the in-vivo simulation device 8 and the induction coil 7, and then simulate various relative positions and relative postures between the in-vitro control device and the human body implanted medical device in the actual application process.

Optionally, the test device further comprises a support plate 21 and an induction coil fixture 74, the test circuit board 5 is parallel and fixedly arranged on the support plate 21, and the object to be tested 6 (the external control device or the circuit board thereof) is vertically inserted into the first installation slot 60 of the test circuit board 5.

Specifically, the support plate 21 is used for carrying the test circuit board 5 and the extracorporeal device 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 to be tested 6 (the external control device or the circuit board thereof) is plugged on the test circuit board 5 and needs to be replaced frequently, the object to be tested 6 (the external control device or the circuit board thereof) is plugged on the first mounting groove 60 in a vertical state for the convenience of mounting and dismounting.

Optionally, the induction coil fixture 74 is vertically and fixedly disposed on the support plate 21, the second installation slot 73 is disposed on the induction coil fixture 74, and the induction coil fixture 74 and the induction coil 7 are disposed perpendicular to the object to be measured 6 (external control device or circuit board thereof).

Specifically, the support plate 21 is further used for carrying the induction coil fixture 74, and the second installation slot 73 is disposed on the induction coil fixture 74, that is, the induction coil 7 is installed on the induction coil fixture 74 through the second installation slot 73. The induction coil tooling 74 and the induction coil 7 are arranged perpendicular to the object to be measured 6 (external control equipment or a circuit board thereof), so that the induction coil 7 and the internal simulation equipment 8 can be arranged oppositely.

Optionally, 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 mounting slot 73 is disposed on an end surface of the insulating plate close to the in-vivo simulation device 8.

Specifically, the induction coil 7 may be interfered by other metal components in the working process, for example, the test circuit board 5, so that the induction coil 7 may be isolated by setting an insulating plate, the induction coil tooling 74 is vertically arranged, and the second installation slot 73 is arranged on the end surface of the induction coil tooling 74 close to the in-vivo simulation device 8, so that the induction coil 7 installed on the second installation slot 73 may be matched with the in-vivo simulation device 8.

The second installation slot 73 may be a groove disposed on the insulation board, 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.

In particular, the presence of some components on the test circuit board 5 may interfere with the induction coil 7, and therefore, 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, and the test circuit board 5 is horizontally mounted in the third mounting slot.

Specifically, the test circuit board 5 can be positioned and fixedly mounted on the support plate 21 through the third mounting slot.

Optionally, the multi-degree-of-freedom displacement platform further comprises a support table 20, wherein the support table 20 is arranged on one side of the multi-degree-of-freedom displacement platform 12, a guide groove 22 is formed in the support table 20, and a 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 relative posture between the second mounting groove 73 and the in-vivo simulation apparatus 8.

Optionally, the direction of movement of the support plate 21 on the guide groove 22 is parallel to the direction of movement of the in vivo simulation device 8 in one degree of freedom included in the multiple degree of freedom displacement platform 12.

In order to adjust the initial position between the second mounting groove 73 and the in-vivo simulation device 8 or manually adjust the position between the second mounting groove 73 and the in-vivo simulation device 8, the guide groove 22 may be guided in parallel to the first driving 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 (an external control device or a circuit board thereof), and the like from interfering with the induction coil 7, the test board 5 and the first test slot 60 should be as far away from the second test slot 70 as possible, but in view of reducing the occupied space, the test board 5, the circuit board to be tested 66, and the induction coil 7 may be arranged in a distributed manner, for example, in a triangular manner, and those skilled in the art may specifically set the test board, the circuit board to be tested 66, and the induction coil 7 according.

Optionally, the in-vivo simulation device installation 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 installed in the arc-shaped groove to be capable of rotating and tilting within a set angle range.

Specifically, the internal simulation device mounting frame 81 is provided with an arc-shaped groove corresponding to the internal simulation device 8, so that the internal simulation device 8 is mounted in the arc-shaped groove to be capable of rotating and inclining within a set angle range, and the spatial posture of the internal simulation device 8 in a human body is simulated.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A charging test method of an external control device for an implantable medical device is characterized by comprising the following steps:

collecting charging parameters of analog equipment;

2. The method of claim 1, wherein the charging parameters of the extracorporeal control apparatus comprise a rectified filtered voltage;

3. Method according to claim 1 or 2, characterized in that the charging parameters of the extracorporeal control device comprise the in-vivo battery voltage U it receives by means of wireless communication₀The charging parameter of the simulation equipment comprises the voltage U of the in-vivo battery₀’；

4. The method according to any of claims 1-3, wherein the charging parameter of the extracorporeal control apparatus comprises an intracorporeal charging current I received by the extracorporeal control apparatus via wireless communication₀The charging parameter of the analog equipment comprises in-vivo charging current I₀’；

5. The method of any one of claims 1-4The method is characterized in that the charging parameters of the extracorporeal control device comprise an intracorporeal charging current I received by the extracorporeal control device in a wireless communication mode₀And charging gear information, wherein the charging parameters of the simulation equipment comprise in-vivo charging current I₀’；

6. The method according to any one of claims 1-5, wherein the charging parameters of the extracorporeal control apparatus comprise its calculated charging efficiency;

7. The method of claim 6, wherein the charging parameter of the extracorporeal control apparatus comprises an operating current I₁Charging emission voltage U₁And its in-vivo charging current I received by wireless communication₀And the in-vivo battery voltage U₀The charging parameters of the simulation device comprise in-vivo chargingCurrent I₀' and in vivo Battery Voltage U₀’；

the actual charging efficiency was calculated from P1, P0, and P0'.

8. The method according to any one of claims 1-7, characterized in that during the wireless charging of the analog device by the control device outside the body, the temperature variation during the charging is simulated by the resistor network; the charging parameter of the extracorporeal control apparatus comprises a coil temperature;

the method further comprises the following steps:

9. The utility model provides an external controlgear's of implanted medical instrument test equipment that charges which characterized in that includes: at least one processor; and a memory communicatively coupled to the at least one processor; wherein the memory stores instructions executable by the at least one processor to cause the at least one processor to perform a method of charging a control device for an external body of an implantable medical device according to any one of claims 1-8.