Test system for in vitro electromagnetic induction coils used in implantable medical devices

Abstract

The present invention provides a testing system for an in vitro electromagnetic induction coil for an implantable medical instrument, comprising: a testing tool and a computer; the testing tool is provided with an in vitro simulation device, an in vivo simulation device and a coil to be tested, the in vitro simulation device and the coil to be tested are connected, and the testing tool is used to change the relative position of the in vivo simulation device and the coil to be tested; the computer is used to control the in vitro simulation device to charge the in vivo simulation device through the coil to be tested, and to control the in vitro simulation device and the in vivo simulation device to communicate through the coil to be tested, and to determine whether the coil to be tested is normal based on charging parameters and communication status.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment detection, and in particular to a testing system for an in vitro electromagnetic induction coil for an implantable medical instrument. Background Art

[0002] An implantable medical device (IMD) is a medical device installed inside the body. It contains a battery and a circuit board (equipped with sensors, chips, and other components). The IMD relies on pre-programmed procedures and operating parameters to deliver treatments. These parameters can be adjusted based on the patient's condition. Because the causes and conditions of each patient's illness vary, IMDs installed in different users typically experience different operating states. These states are reflected in many aspects of the IMD, including battery voltage, operating time, power, current, and frequency.

[0003] Extracorporeal control devices are used in conjunction with implantable medical devices to adjust the device's operating status to meet the user's treatment needs. To ensure the stability and safety of extracorporeal control devices, comprehensive testing is often required. Existing solutions rely on manual testing of the entire device, which is inefficient. Because extracorporeal control devices are closely related to active implantable medical devices, the testing process requires the inclusion of active implantable medical devices, making the testing operation more difficult. Furthermore, the entire control device under test includes components such as circuit boards, batteries, and electromagnetic induction coils, leaving room for improvement in the specificity of the testing process. Summary of the Invention

[0004] In view of this, the present invention provides a testing system for an in vitro electromagnetic induction coil for an implantable medical device, comprising:

[0005] test fixtures and computers;

[0006] The test fixture is provided with an in vitro simulation device, an in vivo simulation device and a coil under test, the in vitro simulation device and the coil under test are connected, and the test fixture is used to change the relative position of the in vivo simulation device and the coil under test;

[0007] The computer is used to control the in vitro simulation device to charge the in vivo simulation device through the measured coil, and to control the communication between the in vitro simulation device and the in vivo simulation device through the measured coil, and to determine whether the measured coil is normal based on the charging parameters and communication status.

[0008] Optionally, the system further includes an impedance testing device for measuring the inductance and resistance of the coil under test, and the computer is used to obtain the inductance and resistance.

[0009] Optionally, the coil under test is equipped with a thermistor; the in vitro simulation device is provided with a resistance network for simulating the change in resistance of the thermistor, and the computer is used to control multiple resistors in the resistance network to be connected to the thermistor in sequence; the in vitro simulation device is used to calculate the thermistor value based on the voltage of the thermistor in the coil under test and the resistance of the resistor connected to it; the computer obtains multiple thermistor values ​​and determines whether the thermistor is normal.

[0010] Optionally, the computer determines whether the calculated values ​​of each thermistor are consistent and consistent with a preset value. When the calculated values ​​of each thermistor are consistent and consistent with the preset value, it is determined that the thermistor itself is in normal condition and is assembled normally; when the values ​​of each thermistor are consistent but inconsistent with the preset value, it is determined that the thermistor is assembled normally but its own condition is abnormal; when the values ​​of each thermistor are inconsistent, it is determined that the thermistor is assembled abnormally.

[0011] Optionally, the coil under test is equipped with a thermistor; the system also includes an environmental simulation device for setting the temperature to simulate the temperature in the working environment of the coil under test, and the coil under test is placed in the environmental simulation device; the in vitro simulation device measures the temperature value through the thermistor at multiple set temperatures; the computer obtains multiple measured temperature values ​​and calculates the error with the set temperature. When each error is within the set range, it is determined that the thermistor is normal.

[0012] Optionally, the coil under test is equipped with a thermistor; the system also includes an environmental simulation device for setting the temperature to simulate the temperature in the working environment of the coil under test, and the coil under test is placed in the environmental simulation device; the environmental simulation device gradually increases the set temperature, and the in vitro simulation device measures the temperature value through the thermistor; the computer is used to determine whether the in vitro simulation device performs an over-temperature protection action at the highest set temperature, and if the over-temperature protection action is performed, it is determined that the thermistor is normal.

[0013] Optionally, a thermistor is installed in the coil under test; the system also includes an environmental simulation device for setting a temperature to simulate the temperature in the working environment of the coil under test, and the coil under test is placed in the environmental simulation device; the environmental simulation device gradually increases the set temperature, and the computer is used to draw a temperature rise curve according to the temperature value measured by the in vitro simulation device through the thermistor; thereafter, the environmental simulation device gradually lowers the set temperature, and the computer is used to draw a temperature drop curve according to the temperature value measured by the in vitro simulation device through the thermistor, and uses the temperature rise curve and the temperature drop curve to calculate hysteresis data, and judges whether the measurement accuracy of the thermistor meets the requirements based on the hysteresis data.

[0014] Optionally, the computer is used to control the test fixture to change the relative position, and control the communication between the external device and the internal device through the coil under test at multiple relative positions to obtain communication results at multiple relative positions.

[0015] Optionally, the computer is used to control the test fixture to change the relative position, and control the in vitro simulation device to charge the in vivo simulation device through the coil under test at multiple relative positions, and obtain charging parameters at multiple relative positions.

[0016] Optionally, the coil under test is a communication coil and a charging coil equipped with a ferrite core.

[0017] The test system provided by the present invention utilizes two simulation devices to respectively simulate an implantable medical device and an in vitro control device thereof. The in vitro simulation device is controlled by a computer to wirelessly charge the in vivo simulation device through the induction coil under test, so that the induction coil under test is in an actual working environment. The test tooling can change the relative position of the simulation device and the induction coil to simulate the charging and communication operations that may occur during actual use by the user. The charging and communication processes are controlled by a computer and the charging parameters and communication status are read to thereby detect whether the induction coil under test and its assembly are normal. The system performs highly targeted tests on the induction coil, and the entire test process is automated, with high work efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The features and advantages of the present invention will be more clearly understood by referring to the accompanying drawings, which are schematic and should not be construed as limiting the present invention in any way. In the accompanying drawings:

[0019] Figure 1 Schematic diagram of the structure of the instruction test system in an embodiment of the present invention;

[0020] Figure 2 Schematic diagram of the structure of the test circuit board and the circuit board under test in an embodiment of the present invention;

[0021] Figure 3 Schematic diagram of the structure of the charging test system in an embodiment of the present invention;

[0022] Figure 4 Schematic diagram of the structure of a test circuit board in an embodiment of the present invention;

[0023] Figure 5 Schematic diagram of the structure of the load configuration unit in an embodiment of the present invention;

[0024] Figure 6 Schematic diagram of the structure of the induction coil in an embodiment of the present invention;

[0025] Figure 7 Schematic diagram of the structure of the electromagnetic induction coil testing system in an embodiment of the present invention;

[0026] Figure 8 Schematic diagram of the structure of the test tool in an embodiment of the present invention;

[0027] Figure 9 2 is a schematic structural diagram of the test tool in an embodiment of the present invention from another perspective. DETAILED DESCRIPTION

[0028] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0029] The embodiment of the present invention provides a command testing system for an in vitro control device for an implantable medical device. The system can be used to test in vitro controllers of rechargeable and non-rechargeable implantable medical devices such as DBS (deep brain stimulation), VNS (vagus nerve stimulation), SCS (spinal cord stimulation) and SNM (sacral neuromodulation). Figure 1 As shown, the system includes a computer 1, a power supply 2, and a test fixture. The test fixture is equipped with an implantable medical device simulator (hereinafter referred to as a simulator or IPG) 8, an induction coil 7, and a test board 5. The test fixture is used to adjust the relative position of the in-vivo simulator 8 and the induction coil 7.

[0030] There are many options for the specific structure of the test tooling. For example, it can be an electric device with one or more guide rails. The in-vivo simulation device 8 and the induction coil 7 can be placed on two platforms that can achieve relative movement, so that the position change between the two can be achieved. The object to be tested in the embodiment of the present 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, which simulates the charging and communication coils of the in-vitro control device; the in-vivo simulation device 8 simulates an implantable medical instrument, and an induction coil is also provided inside the in-vivo simulation device 8. The relative position described in this embodiment can be a relative distance, and can also include relative angles, etc., depending on the structure of the test tooling. The present invention provides a preferred structure, which will be described in detail in subsequent embodiments.

[0031] Test board 5 is provided with an interface for connecting the device under test 6 and the induction coil 7, as well as a control circuit. The induction coil 7 is connected to the device under test 6 via this interface. The control circuit is used to receive and process instructions from computer 1, send instructions to the device under test 6, read information from it, and control other components on test board 5. In one embodiment, the device under test 6 is a complete in vitro control device. To accommodate various types and models of in vitro control devices, the interface for connecting to the device under test 6 is configured as a universal interface, which is connected to the interface on the in vitro control device reserved for program updates via an adapter.

[0032] In another embodiment, the object to be measured 6 is a circuit board of an in vitro control device. Figure 2 As shown, the circuit board connected to the test board 5 includes a base 61 and a measured part 62, wherein the measured part 62 is a circuit board of an in vitro control device. A through hole is provided on the base 61 for accommodating the measured part 62, and the edge of the measured part 62 is connected to the edge of the through hole by a plurality of cuttable parts 63. A plurality of unified interfaces 64 for connecting to the test board 5 are provided on one end of the base 61. The unified interfaces 64 are connected to the connection points on the measured part 62 through wires provided in the base 61 and the measured part 62 respectively. The unified interface 64 can specifically be in the form of a gold finger socket, a flat cable or an aviation plug.

[0033] The tested part of the circuit board provided in this embodiment is surrounded by the base. When testing is required, an operator or equipment such as a robot can clamp the base and plug it into the test board. The base, as the actual force-bearing object, can provide better protection for the tested part. After the test is completed, the tested part can be cut off from the base, making the entire testing process safe and convenient.

[0034] Computer 1 controls the test process, configures the hardware environment, sends test instructions, obtains test parameters, and determines and stores test results.

[0035] Specifically, the computer 1 is connected to the test board 5, the in-vivo simulation device 8 and the power supply 2 respectively. The power supply 2 is connected to the test board 5, and in this embodiment, it supplies power to the test board 5 and the object under test 6. The in-vivo simulation device 8 can be configured with an independent battery as its power supply, or it can also be powered by the power supply 2. The computer 1 can be connected to the test board 5 through a serial port or a network cable interface, and control the object under test 6 to send control instructions to the in-vivo simulation device 8 through the induction coil 7, so that the in-vivo simulation device 8 performs actions corresponding to the control instructions. The computer 1 obtains the action execution result of the in-vivo simulation device 8, obtains the instruction sending and execution status judgment result fed back by the object under test 6 through a wired connection method such as a serial port, determines whether the function of the object under test 6 to issue the control instruction is normal by judging whether the instruction sending and execution are consistent, and determines whether the execution judgment function fed back by the object under test 6 is normal by the actual instruction execution status.

[0036] Before the computer 1 controls the object under test 6 to issue a control command, the test fixture is first adjusted so that the induction coil 7 and the in-vivo simulation device 8 are in a static relative position. This relative position can be a preset fixed position, which can be set differently depending on the type or model of the object under test 6, or it can be a unified fixed position.

[0037] This system can be used to test various control instructions. In one embodiment, the control instructions are used to change the parameters of the stimulation signal output by the in-vivo simulation device 8. Specifically, the computer 1 sends control information to the object under test 6 via the test board 5, causing it to send an instruction to change the stimulation parameters to the in-vivo simulation device 8 via the induction coil 7. For example, the instruction to change the stimulation frequency, amplitude, or the electrode outputting the stimulation signal should be changed. If the in-vivo simulation device 8 is able to receive the control instruction and the instruction content is correct, it should perform the corresponding action, namely, change the aforementioned stimulation parameters.

[0038] There are various ways for computer 1 to obtain feedback from in-vivo simulation device 8 on the results of action execution. In this embodiment, a signal acquisition card 9 captures the stimulation signal output by in-vivo simulation device 8 and transmits it to computer 1. Computer 1 determines the result of the action by evaluating the waveform of the stimulation signal, specifically, by determining whether its frequency and amplitude are consistent with the control instructions. In-vivo simulation device 8 has multiple output electrodes, and acquisition card 9 can capture the signal from each output electrode separately, allowing computer 1 to determine which output electrode is outputting the stimulation signal.

[0039] In another embodiment, control instructions are used to cause the in-vivo simulation device 8 to transmit status information to the object under test 6. Specifically, the computer 1 transmits control information to the object under test 6 via the test board 5, causing the object under test 6 to transmit a feedback instruction to the in-vivo simulation device 8 via the induction coil 7, providing feedback on status information such as the current stimulation frequency, amplitude, and electrodes outputting the stimulation signal. If the in-vivo simulation device 8 receives the control instruction and the instruction content is correct, it will execute the corresponding action, namely, feedback on its own status.

[0040] In this embodiment, the stimulation signal output by the in-vivo simulation device 8 is collected by a signal acquisition card 9 and transmitted to a computer 1. The computer 1 determines whether the operating state of the in-vivo simulation device 8 is consistent with the state information received by the object under test 6 by judging the waveform of the stimulation signal. In other words, the computer 1 determines whether the frequency and amplitude of the stimulation signal are consistent with the content indicated by the state information based on the waveform of the stimulation signal.

[0041] In the third embodiment, the control instruction is used to enable the in-vivo simulation device 8 to turn on or off the functional modules therein, such as the Bluetooth communication module, the stimulation output module, and the like. Specifically, the computer 1 sends control information to the object under test 6 through the test board 5, so that it sends an instruction to turn on or off a certain functional module to the in-vivo simulation device 8 through the induction coil 7, such as turning on or off Bluetooth, turning on or off the stimulation output, and the like. If the in-vivo simulation device 8 can receive the control instruction and the instruction content is correct, the corresponding action should be performed. The computer 1 is used to obtain the status information of the corresponding functional module. For example, the computer 1 collects the working current value of the in-vivo simulation device 8 at this time through an ammeter, a DC power supply, or an acquisition card. If the current increases and the current value is within the expected standard range, the computer can determine that the instruction to turn on Bluetooth is sent and executed successfully.

[0042] The test system provided by the embodiment of the present invention uses a simulation device to simulate an implantable medical instrument and uses an induction coil to simulate the coil of an external control device, so that the object under test is placed in an actual working environment. At the same time, a displacement platform is used to change the relative position of the simulation device and the induction coil to simulate the communication operations that may occur during actual use by the user. The computer controls the object under test to send instructions to the simulation device, and obtains the execution status of the instructions by the simulation device to determine whether the instruction sending function of the external control device is normal. The system performs highly targeted tests on the instruction sending function of the external control device, and the entire testing process is automated, with high work efficiency.

[0043] 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 results, during the test process, the computer 1 controls the test fixture so that the two can control the object under test 6 to send control instructions to the in-vivo simulation device 8 through the induction coil 7 at multiple relative positions, such as sending control instructions at a shortest distance and sending control instructions at a maximum distance. The computer 1 judges whether the sending and execution of instructions at each position are consistent (called distance traversal test). After confirming that it is normal, that is, the sending and execution of instructions 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 mentioned above), and again controls the object under test 6 to send instructions to the in-vivo simulation device 8 through the induction coil 7, and judges whether the sending and execution of instructions are consistent (called formal test).

[0044] The above distance traversal test can be used as a regular test item, that is, the distance traversal test is used for each product; or it can be used only for new products, and a distance traversal test is used when the system is used for the first time to test the first new product, so as to determine whether the instructions are executable at various distances and eliminate the interference of distance factors on the test results. When the same product is tested later, the distance traversal test can be no longer used, and only formal testing can be used.

[0045] In an optional embodiment, the test board 5 is provided with a wireless communication module. The computer 1 wirelessly connects to the device under test 6 via the wireless communication module, sending control information to the device under test 6 or reading its status information via wireless communication methods such as WiFi, Bluetooth, and PPM. When the device under test 6 is set to wireless communication mode, the computer 1 uses the wireless communication module to read the signal strength of the device under test 6 to test whether its wireless communication function is functioning properly.

[0046] The embodiment of the present invention provides a charging test system for an in vitro control device for an implantable medical device. The system can be used to test in vitro controllers of rechargeable implantable medical devices such as DBS (deep brain stimulation), VNS (vagus nerve stimulation), SCS (spinal cord stimulation) and SNM (sacral neuromodulation). Figure 3 As shown, the system includes a computer 1, a power supply 2, a battery simulator 3, and a test fixture. The test fixture is equipped with an implantable medical device simulator (hereinafter referred to as a simulator or IPG) 8, an induction coil 7, and a test board 5. The test fixture is used to adjust the relative position of the in-vivo simulator 8 and the induction coil 7.

[0047] For details about the test tooling, please refer to the above embodiments and the several optional structures provided below.

[0048] The test board 5 is provided with an interface for connecting the object under test 6 and the induction coil 7, and the induction coil 7 is connected to the object under test 6 via the interface. Similar to the above embodiment, the object under test 6 can be an in vitro control device or its circuit board.

[0049] Computer 1 controls the test process, configures the hardware environment, sends test instructions, obtains test parameters, and determines and stores test results.

[0050] Specifically, the computer 1 is connected to the test board 5 and the in-vivo simulation device 8, respectively. To detect the charging function of the object under test 6, a power supply needs to be configured, such as a power supply 2 or a battery simulator 3. The power supply 2 is connected to the test board 5. In this embodiment, the object under test 6 uses the electric energy provided by the power supply 2 to charge the in-vivo simulation device 8, and the in-vivo simulation device 8 is configured with an independent battery as its power supply. The computer 1 can be connected to the test board 5 through a serial port or a network cable interface, and control the object under test 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 under test 6 and the in-vivo simulation device 8, and judges whether the charging function of the object under test is normal based on this.

[0051] The test fixture can change the relative position of the in-vivo simulator 8 and the induction coil 7 at any time. Changes in the distance or position between the in-vivo simulator 8 and the induction coil 7 will affect the charging parameters of the in-vivo simulator 8 and, in turn, the charging parameters of the device under test 6. Charging parameters include charging current and voltage. The computer compares the charging parameters from the in-vivo simulator 8 (the power receiver) with those from the device under test 6 (the power source) to determine whether the charging function of the device under test 6 is functioning properly.

[0052] As a preferred embodiment, the computer 1 obtains charging parameters returned by the device under test 6, including: charging gear, rectifier filter voltage, in-vivo battery voltage U0, in-vivo charging current I0, device under test operating current I1, charging transmission voltage U1, and charging efficiency. U0 is the battery voltage received by the device under test 6 through communication with the in-vivo simulation device 8 at regular intervals, and I0 is the charging current received by the device under test 6 through communication with the in-vivo simulation device 8 at regular intervals. The charging efficiency is calculated by the device under test 6 based on the above parameters.

[0053] The computer 1 obtains the charging parameters of the in-vivo simulation device 8, including: the in-vivo charging current I0 ’ 、In-body battery voltage U0 ’ There are two ways to acquire the charging parameters of the in-vivo simulation device 8: 1. Directly acquire the in-vivo charging current and battery voltage (or power supply voltage) using an acquisition device (acquisition card, power supply, ammeter, battery simulator, etc.); 2. The in-vivo simulation device 8 transmits the data to the device under test 6 via wireless communication, which then transmits the data to the computer via the test board 5 or Bluetooth, Wi-Fi, etc. The data acquired through these two methods can be used to participate in the judgment.

[0054] The computer 1 performs the following operations to determine whether the charging function of the object under test 6 is normal:

[0055] A. Determine whether the rectifier and filter voltage is within a preset range. If not, all charging parameters returned by the DUT 6 are deemed unusable and the charging process is abnormal.

[0056] B. Determine the difference between the internal battery voltage U0 returned by the test object 6 and the internal battery voltage U0 collected from the internal simulation device 8 ’ Whether they are consistent, for example, whether the difference △U between the two is within the preset range. If it is not within the preset range, it is determined that there is an abnormality in the charging process;

[0057] C. Determine the internal charging current I0 and the internal charging current I0 ’ Whether it meets the expected value corresponding to the current charging gear. Specifically, the expected value of the charging current value is different under different charging gears. For example, when charging in gear 4, the corresponding expected current value is about 40mA±10%. If I0 and I0 ’ If any of the values ​​does not meet the expected value, it is determined that the charging process is abnormal;

[0058] D. Determine the difference between the internal charging current I0 returned by the test object 6 and the internal charging current I0 collected from the internal simulation device 8 ’ Whether they are consistent, for example, whether the difference △I between the two is within a preset range. If it is not within the preset range, it is determined that there is an abnormality in the charging process;

[0059] E. Calculate the charging transmission power P1 using the working current I1 and charging transmission voltage U1 of the measured object, calculate the charging reception power P0 using the in-body battery voltage U0 and in-body charging current I0 returned by the measured object 6, and calculate the in-body charging current I0 collected from the in-body simulation device 8. ’ And the internal battery voltage U0 ’ Calculate the charging receiving power P0', then calculate the charging efficiency based on P1, P0 and P0', compare it with the charging efficiency returned by the device under test, calculate the error between the two, and judge whether the error is within the set range, that is, compare whether the charging efficiency returned by the device under test 6 is consistent with the actual calculated charging efficiency. If they are inconsistent, it is determined that there is an abnormality in the charging process.

[0060] The above A must be executed first, BE can be executed selectively or all at once, and the execution order can be set.

[0061] The test system provided by the present invention utilizes a simulation device to simulate an implantable medical device and utilizes an induction coil to simulate the coil of an in vitro control device. A computer controls the object under test to wirelessly charge the simulation device via the induction coil, placing the object under test in an actual working environment. A displacement platform is utilized to change the relative position of the simulation device and the induction coil to simulate charging operations that may occur during actual use by a user. The computer controls the charging process and reads the charging parameters of the object under test and the simulation device, thereby detecting whether the wireless charging function of the object under test is normal. The system performs highly targeted testing on the object under test, and the entire testing process is automated, achieving high work efficiency.

[0062] In a preferred embodiment, the computer 1 controls the test fixture to set multiple relative positions, and controls the object under test 6 to charge the in-vivo simulation device 8 at the multiple relative positions. Specifically, for example, four distance values ​​X1...X4 and charging times t can be preset, so that wireless charging is performed at these four distances for a duration of t.

[0063] Furthermore, the relative position includes relative distance and relative posture. For example, two postures are preset, and at each distance value, the computer 1 adjusts the induction coil 7 and the in-vivo simulation device 8 to adopt two postures for charging duration t respectively, that is, eight wireless chargings are performed, thereby obtaining the charging parameters for each charging. There are multiple optional relative postures, such as the induction coil 7 and the in-vivo simulation device 8 being parallel and aligned, the induction coil 7 and the in-vivo simulation device 8 being offset, the induction coil 7 and the in-vivo simulation device 8 being aligned but not parallel, etc., which are used to simulate the postures that may occur when a user uses an external control device to wirelessly charge an implanted device in the body.

[0064] Furthermore, the computer 1 is used to set the charging gear of the test object 6, so that the test object 6 uses multiple charging gears to charge the in-vivo simulation device 8. Different charging gears refer to different charging voltages and / or charging currents. In combination with the above relative distances and relative postures, for example, four charging gears are preset. A specific charging test process is as follows:

[0065] Computer 1 adjusts the relative distance between induction coil 7 and in-vivo simulation device 8 to X1, sets the device to a first posture, and sequentially adopts the first charging gear ... the fourth charging gear for wireless charging, each lasting t. Then, computer 1 sets the device to a second posture, and sequentially adopts the first charging gear ... the fourth charging gear for wireless charging, each lasting t.

[0066] Computer 1 adjusts the relative distance between induction coil 7 and in-vivo simulation device 8 to X2, sets the device to a first posture, and sequentially adopts the first charging gear ... the fourth charging gear for wireless charging, each lasting t. Then, computer 1 sets the device to a second posture, and sequentially adopts the first charging gear ... the fourth charging gear for wireless charging, each lasting t.

[0067] Thus, wireless charging is performed at four relative distances using various combinations of two relative postures and four charging gears, obtaining the charging parameters of 32 wireless charging operations. For each wireless charging operation, the computer 1 determines whether the charging function of the object under test 6 is normal according to the above method.

[0068] In an optional embodiment, combined with Figure 4 and Figure 5As shown, the test board 5 is provided with an NTC load configuration unit that simulates the resistance change of a thermistor (NTC), which includes a resistor network and an analog switch combination, and is used to simulate the resistance change of the thermistor caused by temperature change during the charging process to the object under test 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. As an example: the main control unit 16 receives instructions from the computer 1 and adjusts the channel connectivity of the analog switch combination in the NTC load configuration 17. Each channel is connected to a resistor. Different channel selections will produce different resistor series and parallel combinations, thereby achieving resistance changes. The computer 1 adjusts the value of the resistor network to simulate temperature changes and obtains the feedback signal (coil temperature) of the object under test 6 in response to the temperature change to determine whether the over-temperature protection function of the object under test is normal. This detection operation can be performed during the above-mentioned detection of the wireless charging function, or it can be performed separately.

[0069] In actual applications, wireless charging of the object under test 6 will cause the metal casing of the implanted device to heat up. The object under test 6 should have an overheating protection function, that is, when the temperature indicated by the feedback signal is greater than the temperature threshold, various countermeasures should be taken, or at least this phenomenon should be monitored. A resistor network is added to the test board 5 of this test system to simulate the resistance value of the thermistor when the temperature changes, which can specifically detect whether the overheating protection function of the object under test is normal.

[0070] In an optional embodiment, the system is configured to include a power supply 2 and a battery simulator 3, which are respectively connected to a test board 5. The computer 1 is used to control the object under test 6 to use the electric energy provided by the power supply 2 to charge the battery simulator 3, and obtain the working parameters of the object under test 6 and the battery simulator 3, thereby determining whether the charging function of the object under test is normal.

[0071] In practice, the device under test 6 is also equipped with a battery and can be charged. To ensure targeted charging testing, the device under test 6 itself does not include a battery in this system. To test its charging function, this embodiment uses a battery simulator 3 as the battery of the device under test 6. Computer 1 controls the power supply 2 to charge the battery simulator 3, and reads operating parameters from a circuit meter 11 to determine whether the charging function is functioning properly.

[0072] An embodiment of the present invention provides a testing system for an in vitro electromagnetic induction coil for an implantable medical device. The system can be used to detect in vitro electromagnetic induction coils that implement charging and communication functions for rechargeable implantable medical devices such as DBS (deep brain stimulation), VNS (vagus nerve stimulation), SCS (spinal cord stimulation), and SNM (sacral neuromodulation).

[0073] Figure 6 FIG1 shows a schematic diagram of an induction coil structure. In this embodiment, the coils to be tested are a communication coil 71 and a charging coil 72 equipped with a ferrite core 70. It should be noted that this system is not limited to Figure 6 The coil shown is tested, and it is also feasible to test other structures or a single communication coil or charging coil.

[0074] like Figure 7 As shown, the electromagnetic induction coil testing system includes a computer 1, a power supply 2, and a test fixture. The test fixture is equipped with an implantable medical device simulator 8, an external simulator 23, and an induction coil 7 (the coil under test). The test fixture is used to adjust the relative position of the in vivo simulator 8 and the induction coil 7.

[0075] Regarding the in vitro simulation device 23, you can refer to the system in the above embodiments. For example, you can use an in vitro control device or its circuit board that has passed the test, combined with the test board 5 as the in vitro simulation device 23; you can also design an in vitro simulation device specifically for testing the induction coil.

[0076] Computer 1 is used to control the in vitro simulation device 23 to charge the in vivo simulation device 8 via the induction coil 7, thereby obtaining charging parameters of the in vivo simulation device 8 and / or the in vitro simulation device 23, and determining whether the induction coil 7 is normal based on the charging status. Regarding the charging control operation and the method for determining the charging parameters, reference can be made to the charging test system and determination method in the above-mentioned embodiment. The difference is that in this embodiment, the induction coil 7 is used as the determination object. For example, when the charging parameters are abnormal, the conclusion obtained is that the induction coil 7 is abnormal.

[0077] Computer 1 is also used to control communication between the in vitro simulation device 23 and the in vivo simulation device 8 via the induction coil. For example, it can obtain the status of instruction transmission and execution, and determine whether the induction coil 7 is normal based on the communication status. Regarding the communication control operation and the method for determining the communication status, reference can be made to the instruction testing system and determination method in the above-mentioned embodiment. The difference is that in this embodiment, the induction coil 7 is used as the determination object. For example, when the in vitro simulation device 23 sends a stimulation parameter setting instruction to the in vivo simulation device 8, and the in vivo simulation device 8 does not execute the corresponding action, the conclusion is that the induction coil 7 is abnormal.

[0078] A key difference between the induction coil testing system and the aforementioned charging and command testing systems is that this system includes an impedance tester 18 (LCR meter), connected to an in vitro simulator 23 and computer 1, for measuring the inductance and resistance of the induction coil 7. Computer 1 obtains these values ​​and compares them with pre-set parameters to determine whether the induction coil 7 is functioning properly. This ensures that the series inductance (Ls) and series resistance (Rs) of the electromagnetic induction coil meet operational requirements and that the parameter range of the ferrite core after installation within the electromagnetic induction coil is within range, facilitating statistical analysis of electromagnetic coil reliability data by the testing system.

[0079] 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 corresponding circuit structures. 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 uses a single-chip microcomputer and analog switches to electrically connect the impedance test device probe to the communication coil or the charging coil. The impedance test device 18 is connected to the computer 1 via a wired connection such as a serial port, receiving control commands from the computer 1 and feeding back test parameters.

[0080] By measuring the two coils separately, two sets of data, namely the resistance value and inductance value of the communication coil and the resistance value and inductance value of the charging coil, can be obtained. The computer 1 can then determine whether the two coils meet the usage requirements.

[0081] For an electromagnetic induction coil equipped with a thermistor, the system can be used to measure whether the thermistor is properly assembled and whether its status is normal. Specifically, there are two optional implementation methods.

[0082] As a first optional solution, the in vivo simulation device 8 is provided with a resistor network for simulating the change in the resistance value of the thermistor. Figure 4 and 5 As shown in the figure, a resistance network is set in the test board 5. The computer 1 controls the multiple resistors in the resistance network to be connected to the thermistor in the coil under test in sequence, and applies a fixed voltage V CCThe in vitro simulation device 23 can collect the voltage value V of the thermistor. NTC , and calculate the thermistor resistance R as follows NTC :

[0083]

[0084] Where R is the resistance of the resistor network to which the thermistor is connected. Different resistors have different R values ​​when connected. For example, when resistor 1 is connected, the calculated R value is NTC1 ...when connecting resistor N, we can calculate R NTCN The computer 1 is used to obtain the calculated thermistor values ​​to determine whether the thermistor is normal.

[0085] Specifically, the computer 1 determines whether the values ​​of the thermistors are consistent and consistent with a preset value. In this solution, the consistency can be within a certain error range;

[0086] When the values ​​of the thermistors are consistent and in accordance with the preset values, it is determined that the thermistor itself is in a normal state and the assembly is normal;

[0087] When the values ​​of the thermistors are consistent but inconsistent with the preset values, it is determined that the thermistor assembly is normal and its own state is abnormal (does not meet the use standard);

[0088] When the thermistor values ​​are inconsistent, it is determined that the thermistor assembly is abnormal.

[0089] As a second alternative, the test system is provided with an environmental simulation device 19, which is used to set at least the temperature, and can also set the pressure and humidity as required to simulate the working environment temperature of the coil under test. The induction coil 7 is placed in the environmental simulation device 19. The computer 1 can adjust the temperature of the environmental simulation device 19 to T1, T2...T n The in vitro simulation device measures the temperature value through the thermistor at multiple set temperatures, and records the temperature values ​​T1', T2'...T measured by the in vitro control device 6 when the temperature is stable. n '.

[0090] The computer obtains multiple measured temperature values ​​and calculates the error ΔT from the set temperature, such as:

[0091]

[0092] From this we can get the error ΔT1 between T1 and T1' n With T n If all the errors are within the set range, the thermistor is considered normal; otherwise, the thermistor is considered to have a problem (either assembly failure or a defect in the device itself) and the test fails.

[0093] Furthermore, the over-temperature protection function of the in vitro simulation device 23 can be used to determine whether the thermistor is functioning properly. Specifically, the environmental simulation device 19 is configured to gradually increase the set temperature. The in vitro simulation device 23 measures the temperature via the thermistor. When the temperature reaches the maximum set temperature, the computer 1 determines whether the in vitro simulation device has activated the over-temperature protection function. If so, the thermistor is determined to be functioning properly.

[0094] Furthermore, it is also possible to determine whether the thermistor measurement accuracy meets the requirements by heating and cooling. Specifically, the environmental simulation device 19 is configured to gradually increase the set temperature first, and then gradually reduce the set temperature. During the heating process, the computer 1 draws a heating curve based on the temperature value measured by the thermistor by the in vitro simulation device 23 (the horizontal axis is the temperature of the environmental simulation device 19, and the vertical axis is the temperature measured by the in vitro simulation device 23); during the cooling process, the computer 1 draws a cooling curve based on the temperature value measured by the thermistor by the in vitro simulation device 23, and calculates the return error data (i.e., the maximum deviation of the two curves) using the heating curve and the cooling curve, and determines whether the thermistor measurement accuracy meets the application requirements based on the hysteresis data. If the hysteresis meets the requirements, it is determined that the thermistor in the electromagnetic induction coil is operating normally and the measurement accuracy meets the requirements. Otherwise, it can be determined that the device has defects or the assembly has hidden dangers, and the test fails.

[0095] like Figure 8 、 Figure 9 As shown, the embodiment of the present application provides an automated testing tool for an in vitro control device for an implantable medical instrument, comprising:

[0096] An in-vivo device tooling 80 includes an in-vivo simulation device mounting frame 81 and an in-vivo simulation device 8 mounted on the in-vivo simulation device mounting frame 81 and used to simulate a human implantable medical device, wherein the in-vivo simulation device 8 is connected to the computer 1;

[0097] The in vitro device tooling 4 includes a first mounting slot 60 for mounting the object to be measured 6 (the in vitro control device or its circuit board) and a second mounting slot 73 for mounting the induction coil 7, which is arranged opposite to the in vivo simulation device 8;

[0098] A multi-degree-of-freedom displacement platform 12, on which the in-vivo device fixture 80 is movably disposed, drives the in-vivo device fixture 80 to move so as to change the relative position and / or relative posture between the in-vivo simulation device 8 and the induction coil 7;

[0099] The test circuit board 5 is connected to the computer 1 and the induction coil 7 respectively. The first mounting slot 60 is set on the test circuit board 5. The test circuit board 5 is connected to the object under test 6 (in vitro control device or its circuit board) installed in the first mounting slot 60 through the first mounting slot 60.

[0100] Specifically, the automated testing tooling provided in the embodiment of the present application can be used to perform automated testing on the object under test 6 (external control device or its circuit board) as the object under test. During the test, the induction coil 7 is used to simulate the coil of the external control device, so that the object under test 6 (external control device or its circuit board) is in an actual working environment. At the same time, the multi-degree-of-freedom displacement platform 12 is used to change the relative position of the in vivo simulation device 8 and the induction coil 7, and the process of matching the in vivo simulation device 8 with the induction coil 7 is used to simulate the control operation of the human implantable medical device through the external control device that may occur during actual use by the user, thereby achieving the purpose of automating the entire testing process and having higher work efficiency.

[0101] In addition, the automated testing tooling provided in the embodiment of the present application can also be used to perform automated testing on the coil of the in vitro control device, namely the induction coil 7, which is the object to be tested. During the test, the object under test 6 (external control device or its circuit board) or the simulation device of the external control device is used as a test tool to place the induction coil 7 in an actual working environment. At the same time, the multi-degree-of-freedom displacement platform 12 is used to change the relative position of the internal simulation device 8 and the induction coil 7. The induction coil 7 matches the internal simulation device 8, and the internal simulation device 8 is charged and communicated through the induction coil 7. Regarding the charging control operation and the judgment method of the charging parameters, the computer 1 is specifically used to control the external control device and its circuit board 6 to charge the internal simulation device 8 through the induction coil 7, and then obtain the charging parameters of the internal simulation device 8 and / or the external control device, and judge whether the induction coil 7 is normal according to the charging situation. In addition, the computer 1 is also used to control the communication between the external control device and the internal simulation device 8 through the induction coil 7, such as obtaining the instruction sending and execution status, and judging whether the induction coil 7 is normal according to the communication status. The above structure is used to simulate the control operation of the user through the external control device on the human implantable medical device that may occur during actual use, thereby achieving the purpose of automating the entire testing process and having high work efficiency. This solves the technical problem in related technologies of how to perform automated testing on the control device under test.

[0102] Furthermore, in the embodiment of the present application, the multi-degree-of-freedom displacement platform 12 is a three-axis displacement platform, which includes a first driving guide rail 121, a second driving guide rail 122 and a third driving guide rail 123. The second driving guide rail 122 is installed on the first driving guide rail 121, the third driving guide rail 123 is installed on the second driving guide rail 122, and the in-vivo simulation device mounting frame 81 is installed on the third driving guide rail 123, wherein 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 in different directions.

[0103] 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 direction of the driving guide rail, thereby realizing the multi-degree-of-freedom movement of the in-vivo simulation device 8. Optionally, for the convenience of operation of the multi-degree-of-freedom displacement platform 12 and a larger displacement space, 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 in directions that are perpendicular to each other.

[0104] 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 guide rail 121 , the second driving guide rail 122 and the third driving guide rail 123 may serve as XYZ axes respectively.

[0105] In addition, in some embodiments, the multi-degree-of-freedom displacement platform 12 can adopt a robotic arm structure. 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 can be changed, but also the relative posture between the in-vivo simulation device 8 and the induction coil 7 can be changed, thereby simulating various relative positions and relative postures between the in-vitro control device and the human implantable medical device in the actual application process.

[0106] Optionally, it also includes a support plate 21 and an induction coil tooling 74, the test circuit board 5 is parallel and fixedly arranged on the support plate 21, and the object to be tested 6 (in vitro control device or its circuit board) is vertically plugged into the first installation slot 60 of the test circuit board 5.

[0107] Specifically, support plate 21 is used to support the test circuit board 5 and the in vitro device fixture 4, and induction coil fixture 74 is used to mount the induction coil 7. Since the test circuit board 5 does not need to be replaced during the test process, for installation stability, the test circuit board 5 is mounted on support plate 21 parallel to the support plate 21. Since the device under test 6 (the in vitro control device or its circuit board) is plugged into the test circuit board 5 and requires frequent replacement, it is vertically mounted in the first mounting slot 60 to facilitate installation and removal.

[0108] Optionally, the induction coil tooling 74 is vertically and fixedly arranged on the support plate 21, the second mounting slot 73 is arranged on the induction coil tooling 74, and the induction coil tooling 74 and the induction coil 7 are arranged vertically to the object under test 6 (in vitro control device or its circuit board).

[0109] Specifically, the support plate 21 is also used to support the induction coil fixture 74, and the second mounting slot 73 is provided on the induction coil fixture 74. In other words, the induction coil 7 is mounted on the induction coil fixture 74 via the second mounting slot 73. The induction coil fixture 74 and the induction coil 7 are arranged perpendicular to the object under test 6 (external control device or its circuit board), so that the induction coil 7 and the in vivo simulation device 8 can be arranged relative to each other.

[0110] Optionally, the induction coil tooling 74 is a structure made of insulating material.

[0111] Specifically, the induction coil fixture 74 is an insulating plate, and the second mounting slot 73 is provided on the end surface of the insulating plate close to the in vivo simulation device 8 .

[0112] Specifically, the induction coil 7 may be interfered with by other metal parts during operation, such as interference from the test circuit board 5. Therefore, the induction coil 7 can be isolated by setting an insulating plate, and the induction coil tooling 74 is set vertically, and the second installation slot 73 is set on the end face 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 can be matched with the in vivo simulation device 8.

[0113] The second mounting slot 73 may be a groove provided on the insulating plate, with the opening direction of the groove facing the multi-degree-of-freedom displacement platform 12 .

[0114] Optionally, the material of the insulating plate includes a non-metallic material.

[0115] Optionally, the induction coil fixture 74 is blocked between the test circuit board 5 and the second installation slot 73 .

[0116] Specifically, some components on the test circuit board 5 may interfere with the induction coil 7 , and therefore, they may be blocked between the test circuit board 5 and the second mounting slot 73 by an insulating plate.

[0117] Optionally, a third installation slot is provided on the support plate 21 , and the test circuit board 5 is horizontally installed in the third installation slot.

[0118] Specifically, the test circuit board 5 can be positioned and fixedly installed on the support plate 21 through the third installation slot.

[0119] Optionally, a support platform 20 is further included. The support platform 20 is arranged on one side of the multi-degree-of-freedom displacement platform 12 . A guide groove 22 is provided on the support platform 20 , and a support plate 21 is movably mounted on the guide groove 22 .

[0120] Specifically, the support plate 21 is installed on the guide groove 22 of the support platform 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 installation slot 73 and the in vivo simulation device 8.

[0121] Optionally, the moving direction of the support plate 21 on the guide groove 22 is parallel to the moving direction of the in vivo simulation device 8 on one degree of freedom included in the multi-degree-of-freedom displacement platform 12 .

[0122] In order to facilitate the adjustment of the starting position between the second mounting slot 73 and the in vivo simulation device 8, or to manually adjust the position between the second mounting slot 73 and the in vivo simulation device 8, the guide of the guide groove 22 can be parallel to the first driving guide rail 121 serving as the X-axis.

[0123] It should be noted that in order to prevent the test circuit board 5, the object under test 6 (external control equipment or its circuit board), etc. from interfering with the induction coil 7, the test board 5 and the first mounting slot 60 should be as far away as possible from the second mounting slot 73. However, in order to reduce the occupied space, the test board 5, the circuit board under test 66 and the induction coil 7 can be arranged in a distributed manner, for example, in a triangular arrangement. Technicians in this field can make specific arrangements according to actual needs.

[0124] Optionally, the in vivo simulation device mounting frame 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 achieve rotation and tilt within a set angle range.

[0125] Specifically, the in-vivo simulation device mounting frame 81 is provided with an arc-shaped groove corresponding to the in-vivo simulation device 8, so that the in-vivo simulation device 8 installed in the arc-shaped groove can be rotated and tilted within a set angle range, thereby simulating the spatial posture of the in-vivo simulation device 8 in the human body.

[0126] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A testing system for an in vitro electromagnetic induction coil for an implantable medical device, characterized in that: include: test fixtures and computers; The test fixture is provided with an in vitro simulation device, an in vivo simulation device and a coil under test, the in vitro simulation device and the coil under test are connected, and the test fixture is used to change the relative position of the in vivo simulation device and the coil under test; The computer is used to control the in vitro simulation device to charge the in vivo simulation device through the coil under test, and to control the communication between the in vitro simulation device and the in vivo simulation device through the coil under test, and to determine whether the coil under test is normal based on the charging parameters and communication status. The computer controls the in vitro simulation device to send control instructions to the in vivo simulation device through the coil under test, so that the in vivo simulation device performs actions corresponding to the control instructions. The computer obtains the action execution results of the in vivo simulation device and the instruction sending and execution status judgment results fed back by the in vitro simulation device, and determines whether the coil under test is normal by judging whether the instruction sending and execution are consistent.

2. The system according to claim 1, wherein: The system further includes an impedance testing device for measuring the inductance and resistance of the coil under test, and the computer is used to obtain the inductance and resistance.

3. The system according to claim 1 or 2, characterized in that The coil under test is equipped with a thermistor; the in vitro simulation device is provided with a resistor network for simulating the change in the resistance value of the thermistor, and the computer is used to control multiple resistors in the resistor network to be connected to the thermistor in sequence; the in vitro simulation device is used to calculate the thermistor value based on the voltage of the thermistor in the coil under test and the resistance value of the resistor connected to it; the computer obtains multiple thermistor values ​​and determines whether the thermistor is normal.

4. The system according to claim 3, characterized in that The computer determines whether the values ​​of the thermistors are consistent and consistent with preset values. When the values ​​of the thermistors are consistent and consistent with the preset values, it is determined that the thermistors themselves are in normal state and are assembled normally. When the values ​​of the thermistors are consistent but inconsistent with the preset values, it is determined that the thermistors are assembled normally but are abnormal. When the values ​​of the thermistors are inconsistent, it is determined that the thermistors are assembled abnormally.

5. The system according to claim 1 or 2, characterized in that The coil under test is equipped with a thermistor; the system also includes an environmental simulation device for setting a temperature to simulate the temperature of the working environment of the coil under test, and the coil under test is placed in the environmental simulation device; the in vitro simulation device measures temperature values ​​using the thermistor at multiple set temperatures; the computer obtains multiple measured temperature values ​​and calculates the error with the set temperature. When each error is within a set range, it is determined that the thermistor is normal.

6. The system according to claim 1 or 2, characterized in that The coil under test is equipped with a thermistor; the system also includes an environmental simulation device for setting a temperature to simulate the temperature of the working environment of the coil under test, and the coil under test is placed in the environmental simulation device; the environmental simulation device gradually increases the set temperature, and the in vitro simulation device measures the temperature value through the thermistor; the computer is used to determine whether the in vitro simulation device performs an over-temperature protection action at the highest set temperature, and if the over-temperature protection action is performed, it is determined that the thermistor is normal.

7. The system according to claim 1 or 2, characterized in that The coil under test is equipped with a thermistor; the system also includes an environmental simulation device for setting a temperature to simulate the temperature of the working environment of the coil under test, and the coil under test is placed in the environmental simulation device; the environmental simulation device gradually increases the set temperature, and the computer is used to draw a temperature rise curve based on the temperature values ​​measured by the thermistor; then, the environmental simulation device gradually decreases the set temperature, and the computer is used to draw a temperature drop curve based on the temperature values ​​measured by the thermistor, and calculate hysteresis data using the temperature rise curve and the temperature drop curve, and judge whether the measurement accuracy of the thermistor meets the requirements based on the hysteresis data.

8. The system according to claim 1 or 2, characterized in that The computer is used to control the test fixture to change the relative position, and control the communication between the in vitro simulation device and the in vivo simulation device through the coil under test at multiple relative positions to obtain communication results at multiple relative positions.

9. The system according to claim 1 or 2, characterized in that The computer is used to control the test fixture to change the relative position, and control the in vitro simulation device to charge the in vivo simulation device through the coil under test at multiple relative positions, and obtain charging parameters at multiple relative positions.

10. The system according to claim 1 or 2, characterized in that The coils under test are the communication coil and the charging coil equipped with ferrite cores.

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