Reliability testing methods and equipment for external control devices used in implantable medical instruments

Abstract

This invention provides a reliability testing method and apparatus for an external control device for implantable medical instruments. The method includes: setting the charging power of the test object; adjusting the spacing and / or orientation of the induction coils of each test object according to the current charging power; controlling each test object to perform wireless charging based on the current charging power and the current spacing and / or orientation of the induction coils; and acquiring the operating parameters of each test object.

Description

Technical Field

[0001] This invention relates to the field of medical device testing technology, specifically to a reliability testing method and equipment for an external control device used in implantable medical instruments. Background Technology

[0002] An implantable medical device (IMD) is a medical device implanted inside a user's body. This device contains a battery and a circuit board (with sensors, chips, and other components). The IMD relies on pre-programmed procedures and operating parameters to deliver specific therapeutic effects. An external control device works in conjunction with the implantable medical device to adjust its operation and ensure it meets the user's treatment needs.

[0003] To ensure the stability and safety of external control devices, reliability testing is typically required. Reliability testing is an activity conducted to assess the functional reliability of a product under specified, intended usage conditions. It involves exposing the product to artificial environmental conditions to evaluate its performance under real-world usage conditions and to analyze the extent and mechanism of environmental influence.

[0004] One important function of external control devices is to wirelessly charge IMDs, and wireless charging is an indispensable part of reliability testing. According to the hardware principles of wireless charging, the coil that outputs electrical energy will generate electromagnetic radiation. To improve efficiency, multiple IMDs are usually placed in the same environment for reliability testing. Electromagnetic interference may occur between the IMDs, thus affecting the test results. Summary of the Invention

[0005] In view of this, the present invention provides a reliability testing method for an external control device for implantable medical instruments, comprising:

[0006] Set the charging power of the object being tested;

[0007] Adjust the spacing and / or orientation of the induction coils of each object under test according to the current charging power;

[0008] Control each object under test to perform wireless charging based on the current charging power and the current spacing and / or orientation of the induction coils;

[0009] Obtain the working parameters of each test object.

[0010] Optionally, the method is executed multiple times for multiple rounds of testing, with different charging power and different spacing and / or orientation of the induction coils in each execution, in order to obtain the operating parameters of the test object when performing wireless charging with a combination of multiple charging power and multiple spacing and / or orientations.

[0011] Optionally, the method is executed multiple times to perform multiple rounds of testing, specifically including:

[0012] Each test object is sequentially set to perform wireless charging at multiple charging levels. The working parameters at each charging level are obtained. The working parameters are compared with the theoretical values ​​to determine whether each charging level has passed the current test. When it is determined that the current charging level of the test object has passed the current test, it is switched to the next charging level for the next test.

[0013] Optionally, when it is determined that the current charging level of the tested object has failed the test, the induction coil of the tested object that has failed the test is set to take multiple postures in sequence, and wireless charging is performed at the current charging level under the multiple postures. The working parameters under each posture are obtained, and the current charging level is determined again by comparing the working parameters with the theoretical value.

[0014] Optionally, after determining that the current charging level has passed this round of testing, the device under test is switched to the next charging level to perform wireless charging in order to conduct the next round of testing, while maintaining the posture that enabled it to pass the test.

[0015] Optionally, if the current charging level fails the test again, the status information of the tested object is obtained to determine whether the working status of the tested object is abnormal.

[0016] Optionally, when setting each object under test to perform wireless charging at multiple charging levels in sequence, the induction coil and the object under test are set to be perpendicular to each other and at a set distance.

[0017] Optionally, the parameters include the total power consumption of the object under test, the emission voltage, and the current flowing through the induction coil.

[0018] Accordingly, the present invention provides a reliability testing device for an external control device for implantable medical devices, comprising: at least one processor; and a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the at least one processor, the instructions being executed by the at least one processor to cause the at least one processor to perform the aforementioned reliability testing method for an external control device for implantable medical devices.

[0019] According to the reliability testing method and equipment provided by the present invention, the charging power of the test object is first set, and the spacing between each test object and the orientation of the induction coil are set accordingly. Then, wireless charging is performed to obtain the working parameters of each test object. During the test, electromagnetic interference between each induction coil when outputting electrical energy is avoided. Thus, the reliability of the test object can be accurately analyzed according to the working parameters, and batch reliability testing of multiple test objects can be realized. Attached Figure Description

[0020] The features and advantages of the invention will be more clearly understood by referring to the accompanying drawings, which are schematic and should not be construed as limiting the invention in any way. In the drawings:

[0021] Figure 1 This is a schematic diagram of the reliability testing system in an embodiment of the present invention;

[0022] Figure 2 This is a schematic diagram of a preferred reliability testing system according to an embodiment of the present invention;

[0023] Figure 3 This is a schematic diagram of the structure of a reliability testing system with an in vivo simulation device in an embodiment of the present invention;

[0024] Figure 4 This is a structural diagram of a test fixture according to an embodiment of the present invention;

[0025] Figure 5 This is a structural diagram of the space adjustment mechanism in an embodiment of the present invention;

[0026] Figure 6 This is a structural diagram of another testing fixture in an embodiment of the present invention;

[0027] Figure 7 This is a flowchart of a computer-executed reliability testing method in an embodiment of the present invention. Detailed Implementation

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] This invention provides a reliability testing system for external control devices used in implantable medical devices. This system can be used to perform reliability testing on the external controllers of 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 10, a power supply system 7, a testing fixture 6, and an environmental simulation device 1.

[0030] The testing fixture 6 is equipped with multiple testing units 601. Each testing unit 601 is used to place the test object 4 and the induction coil 5. The test object 4 can be the external control device (complete unit) of an implantable medical device or its circuit board. In an embodiment testing the complete unit, the testing unit 601 is equipped with a bracket or platform for placing the external control device, and the induction coil 5 is directly connected to the complete unit. In an embodiment where the test object is a circuit board, such as... Figure 2 As shown, the test unit 601 also includes a test circuit board 3 for connecting the circuit board under test. The test circuit board 3 has an interface for connecting the circuit board under test and the induction coil 5, as well as peripheral circuitry to support its normal operation, thereby enabling the connection between the induction coil 5 and the circuit board under test and supporting the normal operation of the circuit board under test.

[0031] The test fixture 6 can adjust the spacing between the various test units 601 and / or adjust the orientation of the induction coil 5, where orientation refers to the coil's orientation, angle, etc. The test fixture 6 has several optional implementations, which will be described in detail below. In an optional embodiment, the test fixture also has a vibration function; each test unit 601 vibrates, causing the test object 4 and the induction coil to be in a vibrating state, thereby verifying whether the electronic component connections or soldering are secure and reliable.

[0032] The testing fixture 6 is installed in the environmental simulation device 1, which is used at least to set the ambient temperature so that the test object 4 is placed at the set temperature. For example, the ambient temperature can be set to 37°C to simulate the surface temperature of human skin. In an optional embodiment, the environmental simulation device 1 can also set various environmental parameters such as ambient humidity and vacuum level to place the test object in a more diverse and extreme environment.

[0033] The power supply system 7 is used to supply power to the test object. The power supply system 7 is connected to all test units 601 and can simultaneously supply power to all test objects 4. In this embodiment, the power supply system 7 serves as the power source for the test object 4, enabling it to output electrical energy.

[0034] Computer 10 is used to control the object under test 4 to perform wireless charging through induction coil 5 and to acquire the charging parameters of the object under test. For example... Figure 2 As shown, in this embodiment, the system further includes a data acquisition and monitoring system 8, electrically connected to each test unit 601, which acquires and monitors data from each test unit 601 in real time and transmits the data to the computer 10. The system also includes a communication module 9, connected to both each test unit 601 and the computer 10, which can be used for communication between the computer 10 and the test object 4. Through the communication module 9, the computer 10 can identify the type, operating status, and other information of each test object 4 and send control commands to it. The system also includes a database 11, connected to the computer 10, used to store test data from the reliability testing process.

[0035] This system allows the tested object to perform wireless charging at different set temperatures, outputting energy through induction coils. The testing fixture can adjust the spacing of the test units and the orientation of the induction coils to avoid electromagnetic interference between the induction coils when they output electrical energy. The computer collects the test results of the tested object under these test conditions, and can then accurately analyze the reliability of the tested object, enabling batch reliability testing of multiple tested objects.

[0036] like Figure 7 As shown, computer 10 in the above system performed the following operations:

[0037] S1, Set the charging power of the object being tested;

[0038] S2, adjust the spacing and / or orientation of the induction coils of each object under test according to the current charging power;

[0039] S3, control each object under test to perform wireless charging based on the current charging power and the current spacing and / or orientation of the induction coils;

[0040] S4, obtain the working parameters of each test object.

[0041] In a preferred embodiment, the above method is executed multiple times to perform multiple rounds of testing. The charging power set in each execution process is different, and the spacing and / or orientation of the corresponding induction coils are different, so as to obtain the working parameters of the test object when performing wireless charging with a combination of multiple charging powers and multiple said spacings and / or orientations.

[0042] Computer 10 is connected to test fixture 6. Computer 10 is used to set the charging power of the test object 4, and to control the test fixture 6 to adjust the spacing of each test unit 601 and / or adjust the orientation of the induction coil according to the current charging power.

[0043] External control devices typically have multiple charging levels, each with different charging current and voltage (i.e., different charging power). The computer 10 can send commands to the object under test 4 to switch charging levels. Different charging power levels produce different electromagnetic radiation intensities and ranges. For example, higher charging power produces greater electromagnetic radiation intensity and a wider radiation range. In this case, the testing fixture 6 needs to adjust the distance between each induction coil 5 to be sufficiently large and adjust the angle so that adjacent induction coils 5 do not face each other. Conversely, when the charging power is lower, a closer spacing can be set, and so on. For reference, the spacing between adjacent induction coils 5 can be configured to 4-10 cm under various charging levels.

[0044] To test all charging levels, the computer 10 sequentially sets each device under test (DUT) 4 to perform wireless charging at multiple charging levels, acquires the operating parameters for each charging level, and determines whether each charging level passes the test by comparing the operating parameters with theoretical values. For reference, the fixture parameters include, but are not limited to, the total power consumption of the DUT 4, the transmission voltage, and the current flowing through the induction coil 5. If all parameters match the theoretical values ​​(with a certain margin of error allowed), the computer 10 determines that the current charging level has passed the test; otherwise, it determines that the test has failed.

[0045] When the computer 10 determines that the current charging level of the test object 4 has passed the test, it switches it to the next charging level. The spacing between adjacent induction coils 5 is different under different charging levels (that is, the spacing between adjacent test units 601 is different). Higher charging levels have higher charging power and larger spacing between each test unit 601, and vice versa.

[0046] For example, if the tested object 4 has four charging levels, the charging level is controlled to gradually increase from level 1 to level 4 (one cycle), and then directly return to level 1 (entering the next cycle). During this process, the computer 10 controls relevant equipment to adjust the spacing and attitude of the induction coils 5 according to requirements or pre-set programs, and to monitor and communicate data throughout the entire process. The entire reliability test requires multiple cycles. Specifically:

[0047] First, the ambient temperature is set. The computer 10 can control the environmental simulation device 1 to set the temperature to a preset value (e.g., 55°C). The set temperature can be different in different cycles.

[0048] Set the induction coil 5 to its initial position (the induction coil 5 is placed horizontally in each test unit, perpendicular to the test object 4, and at least 4cm apart). Set the spacing between adjacent induction coils 5 to L0 (for example, L0 = 4cm, this distance is determined by calculation or pre-experiment to ensure that they will not interfere with each other during charging at level 1). The computer 10 communicates with the test object 4 through the communication module 9 to obtain basic information and current status. Once the test object 4 is in a normal state, the experiment can begin.

[0049] Computer 10 sends a charging control command to cause the tested object 4 to start charging at level 1. Computer 10 acquires parameters such as the total power consumption, emission voltage, and current flowing through the induction coil 5 for each tested object 4 through the data acquisition and monitoring system 8. After continuous monitoring for a set sampling rate for a period of time (e.g., 30 minutes), computer 10 compares these parameters with theoretical values ​​to determine whether each tested object 4 passes level 1 of the test.

[0050] Because it is a batch test, some tested items may pass the test while others fail. For example, if a tested item 4 fails the first charging level test, the computer 10 can directly conclude that the tested item is unqualified. However, to avoid misjudgment, in a preferred embodiment, the computer 10 will retest the tested items that failed the current charging level test.

[0051] Before conducting a retest, the computer 10 acquires the status information of the device under test (DUT) 4 to determine whether its operating status is abnormal. Specifically, the computer 10 can acquire the basic information and current status of the DUT through the communication module 9. If the DUT's status is abnormal (no communication response or other abnormal return), the computer 10 performs relevant operations according to a preset program. For example, if it determines that the DUT 4 is in a powered-off state, the computer 10 controls the power supply system 7 to cut off the power to the DUT 4 and then performs a power-on operation to restart the DUT.

[0052] Regarding the retest, specifically, when the computer 10 determines that the current charging level of the tested object has failed the test, it sets the induction coil 5 of the tested object 4 that failed the test to take multiple postures in sequence, maintains the current charging level in multiple postures to perform wireless charging, and obtains the working parameters in each of the postures. By comparing the working parameters with the theoretical values, it determines again whether the current charging level has passed the test.

[0053] As a specific example, the induction coil 5, starting from a perpendicular position to the object under test 4, rotates twice (a total of 10 degrees) in 5-degree increments, first towards the object under test 4, then returns directly to the perpendicular position and holds for 5 minutes. It then rotates twice in the opposite direction (a total of 10 degrees) before finally returning to the perpendicular position. Each rotation of the induction coil 5 is held for 5 minutes, for a total of 25 minutes. Simultaneously, the computer 10 controls the data acquisition and monitoring system 8 to acquire 5 sets of data from the object under test 4, including parameters such as total power consumption, transmission voltage, and current flowing through the induction coil 5. The computer 10 compares these parameters with theoretical values ​​to determine whether the test has passed.

[0054] The purpose of the retest is to verify whether the coil orientation in the test unit will cause the test to fail, assuming that the coil spacing of each test unit is sufficient and will not interfere with each other. That is, the interference comes from inside the test unit, such as the coil orientation being affected by foreign objects (connecting wires).

[0055] If, through the above-mentioned further judgment, one set of monitoring parameters for the tested object 4 is found to be able to pass the Level 1 charging function test, then the object is kept in the position that allows it to pass the test, and the device is switched to the next charging level for wireless charging. That is, the computer 10 controls the testing unit 601 to adjust the induction coil posture 5 to the posture corresponding to when the Level 1 charging function test is passed, and maintains this posture to proceed to the next level of testing. If none of the monitoring parameters for the tested object 4 pass the Level 1 charging function test, then the Level 1 charging test for the tested object 4 is determined to have failed in this cycle, and the subsequent testing of the tested object in this cycle is stopped. The test can be restarted in the next cycle.

[0056] The computer 10 does not adjust the position and orientation of other test units 601 besides the test object 4. The other test objects 4 continue to perform the first-level charging function test, and the monitored parameters are used to compare and judge with the theoretical values.

[0057] For the test object 4 that passes the first-level charging test, the computer 10 controls the test fixture 6 to adjust the spacing of the test units 601 so that the spacing between adjacent induction coils 5 is L1 (for example, L1 = 6cm, this distance is determined by calculation or pre-experiment to ensure that the coils will not interfere with each other in this posture (non-parallel coaxial) during second-level charging), and the induction coils 5 maintain the posture of the previous step. The computer 10 sends a charging control command to start the second-level charging of the test object 4; the computer 10 acquires parameters such as the power consumption value, emission voltage value, and current value flowing through the induction coil 5 of the test object 4 through the data acquisition and monitoring system 8; after continuous monitoring for a period of time (1 hour), the computer 10 compares these parameters with theoretical values ​​to make a judgment.

[0058] Similar to the test from level 1 to level 2, the computer 10 will test the test object at levels 3 and 4. After testing all levels, one cycle is completed, and then the next cycle can be performed. For example, for the level 3 test, the distance between adjacent induction coils 5 is L3 (e.g., L3 = 8cm); for the level 4 test, the distance between adjacent induction coils 5 is L4 (e.g., L4 = 10cm).

[0059] If the object under test is an external control device with a battery, the power supply system 7 can also charge the object under test 4, thereby testing whether the state of the object under test 4 is normal when it is being charged. During this process, the environmental simulation device 1 can also set the temperature.

[0060] In the charging test embodiment, the computer 10 collects the charging current of the power supply system 7 for each test object 4, and the computer 10 obtains the current basic information and status of the test object 4, mainly focusing on the current battery voltage of the test object 4.

[0061] When the power supply is charging the rechargeable battery, the charging current is basically constant when the battery voltage is in a certain low range. At this time, the charging current value can be used to determine whether the charging function is normal. Based on the current battery voltage, the computer 10 compares the charging current value collected from the power supply system 7 with the theoretical charging current value. If it is within the allowable error range, the charging function test of the tested object 4 is judged to have passed; otherwise, it fails (for example, the tested object 4 may have a charging circuit fault or a battery fault).

[0062] like Figure 3 As shown, in another embodiment, the test unit 601 is also used to place an implantable medical device (IPG) simulator, adding the in vivo device to the reliability test. The in vivo simulator can be configured with an independent battery as its power source, or it can be powered by the power supply system 7. After the in vivo simulator is added, the system can be used to perform command testing. The computer 10 controls the test object 4 to send control commands to the in vivo simulator through the induction coil 5, so that the in vivo simulator performs actions corresponding to the control commands, and obtains the action execution results fed back by the in vivo simulator, as well as the command sending, execution, and analysis results fed back by the test object.

[0063] Computer 10 acquires the action execution results of the simulated device inside the body, and obtains the command sending and execution status judgment results fed back by the tested object 4 through wired connection methods such as serial port. It determines whether the function of the tested object 4 issuing control commands is normal by judging whether the command sending and execution are consistent, and determines whether the execution judgment function fed back by the tested object 4 is normal by judging the actual command execution status.

[0064] In the previous embodiment, the test object 4 performed wireless charging but there was no receiver. In this embodiment, however, the in vivo simulation device can be used to receive the electrical energy output by the test object 4 through the induction coil 5. With the presence of a receiver, the electromagnetic radiation range of the induction coil 5 will be reduced, thus the requirements for the spacing of the test units 601 and the coil orientation are relatively relaxed.

[0065] The following is combined with Figures 4-6 The structure of test fixture 6 is described. Figure 4 and Figure 5 A test fixture 6 is shown, comprising: an electric translation stage guide rail 12; a plurality of test units 18 disposed on the electric translation stage guide rail 12, each test unit 18 comprising: an electrically controlled translation stage 14 movable on the electric translation stage guide rail 12 to adjust the spacing between the test units 18; a test circuit board 3 disposed on the electrically controlled translation stage 14; and a test object 4 electrically connected to the test circuit board 3, wherein the test object 4 is an external control device of an implantable medical device or its circuit board; a space adjustment mechanism 15 disposed on the electrically controlled translation stage 14; and an induction coil 5 disposed on the space adjustment mechanism 15, wherein the induction coil 5 is electrically connected to the test object 4 or the test circuit board 3; and the space adjustment mechanism 15 is used to adjust the relative spatial position of the induction coil 5 of each test unit 18.

[0066] In this embodiment, to make the distance adjustment between adjacent test units 18 more intuitive, the electric translation stage guide rail 12 adopts a horizontal linear guide rail. To reduce the footprint of the test fixture, the electric translation stage guide rail 12 is arranged horizontally so that the electrically controlled translation stage 14 can move horizontally. The test object 4 is the external control device of an implantable medical instrument or its circuit board. The test position of the test object 4 is fixed and always perpendicular to the horizontal plane. In the initial test state, the induction coil 5 is set perpendicular to the test object 4. To improve test efficiency, multiple test units 18 are set, such as... Figure 4 As shown, the following example illustrates the installation of five test units 18 sequentially on the electric translation stage guide rail 12. The electrically controlled translation stage 14 has the function of automatically moving on the electric translation stage guide rail 12, thereby adjusting the distance between adjacent test units 18. The test circuit board 3 is fixed on the electrically controlled translation stage 14, and it has an interface for connecting the test object 4 and the induction coil 5, as well as peripheral circuitry to support its normal operation, enabling the connection between the induction coil 5 and the test object 4 and supporting the normal operation of the test object 4. The space adjustment mechanism 15 is used to adjust the relative spatial position of the induction coil 5 of each test unit 18, including adjusting the height, tilt angle, etc. of the induction coil 5.

[0067] This test fixture outputs energy outward through the induction coil 5. The test fixture realizes automatic adjustment of the spacing of the test units 18 through the electronically controlled translation stage, and automatic adjustment of the posture of the induction coil 5 through the space adjustment mechanism 15. This avoids electromagnetic interference between the various induction coils 5 when they output electrical energy, improves test efficiency, and solves the problem in related technologies that electromagnetic interference occurs when multiple test objects are under test in the same test environment and that manual testing is inefficient when testing the reliability of external control equipment.

[0068] like Figure 4 As shown, the electrically controlled translation stage 14 can slide horizontally on the electric translation stage guide rail 12. It includes a self-propelled roller assembly on the electric translation stage guide rail 12 and a mounting platform on the self-propelled roller assembly. The test circuit board 3, the test object 4 and the space adjustment mechanism 15 are all mounted on the mounting platform.

[0069] Specifically, it should be noted that the electrically controlled translation stage 14 is composed of a self-propelled roller assembly and a mounting platform. The self-propelled roller assembly includes a drive unit and four wheels to ensure stability during movement. The drive unit rotates the wheels, enabling movement on the electric translation stage guide rail 12. The mounting platform is a cuboid structure fixed to the self-propelled roller assembly. The mounting platform has mounting positions for the test circuit board 3, the test object 4, and the space adjustment mechanism 15. The test circuit board 3 can be embedded in the mounting platform, the test object 4 can directly interface with the test circuit board 3, and the space adjustment mechanism 15 can be fixed to the mounting platform with screws.

[0070] like Figure 4 As shown, the space adjustment mechanism 15 includes a lifting platform 13 mounted on the electrically controlled translation platform 14, and an induction coil 5 mounted on the lifting platform 13. The lifting platform 13 is used to adjust the relative height position of the induction coils 5 of each adjacent test unit 18.

[0071] It should be noted that the lifting platform 13 can adopt lifting devices in related technologies, including scissor lifting mechanism 131, screw lifting mechanism or cylinder lifting mechanism, etc., which are not limited here. In this embodiment, the height of the induction coil 5 is adjusted by the lifting platform 13, and the relative spatial position of the induction coils of different test units is adjusted, thereby preventing electromagnetic interference between different test units.

[0072] like Figure 5As shown, to further adjust the attitude of the induction coil 5 during the testing process, the spatial adjustment mechanism 15 also includes an attitude adjustment mechanism mounted on the lifting platform 13 for adjusting the relative attitude of the induction coils 5 of each testing unit 16. The attitude adjustment mechanism is a tilt adjustment component 21, with the induction coil 5 connected to the output end of the tilt adjustment component 21 to adjust the tilt angle of the induction coil 5. The tilt adjustment component 21 includes a rotary motor 20 fixed on the lifting platform 13, with the output end of the rotary motor 20 connected to the end of the induction coil 5, allowing the induction coil 5 to rotate around its own axis. The induction coil 5 is rotated on the lifting platform 13 by the rotary motor 20, thereby adjusting its tilt angle and orientation.

[0073] As a specific example, the induction coil 5, starting from a position perpendicular to the object 4, rotates twice (a total of 10 degrees) in increments of 5 degrees, first towards the object 4, then returns directly to the perpendicular position and holds for 5 minutes. It then rotates twice in the opposite direction (a total of 10 degrees) before finally returning to the perpendicular position. Each rotation of the induction coil 5 is held for 5 minutes, for a total of 25 minutes.

[0074] like Figure 5 As shown, in order to further reduce the size of the test fixture and reserve sufficient space for tilt adjustment of the induction coil 5, the tilt adjustment assembly 21 also includes a groove 17 formed on the upper end of the lifting platform 13, the induction coil 5 is disposed in the groove 17, and there is a gap between the lower surface of the induction coil 5 and the bottom surface of the groove 17 for the rotation of the induction coil 5; the rotary motor 20 is fixed on the end face of the lifting platform 13, and the output end of the rotary motor 20 extends into the groove 17 and is connected to the end of the induction coil 5.

[0075] Specifically, it should be noted that the bottom wall of the groove 17 has an arc-shaped groove 16 corresponding to the induction coil 5, which is used for the induction coil 5 to rotate and tilt within a set angle. Taking the induction coil 5 rotating 10 degrees in both the positive and negative directions as an example, the depth of the arc-shaped groove 16 should meet the rotation requirement, and the shape of the arc-shaped groove 16 is similar to the shape of the induction coil 5. The lifting platform 13 has a protrusion 19, and a mounting hole is opened in the protrusion 19. A rotating shaft is rotatably mounted in the mounting hole through a bearing. The first end of the rotating shaft is connected to the end of the induction coil 5 located in the groove 17, and the second end is connected to the rotary motor 20 located at the end of the lifting platform 13. The rotating shaft can be set coaxially with the induction coil 5, so that the rotary motor 20 drives the induction coil 5 to rotate around its own axis by a certain angle, thereby realizing the adjustment of the tilt angle and orientation of the induction coil 5.

[0076] like Figure 4 As shown, in order to reduce electromagnetic interference and ensure test accuracy, the distance between the induction coil 5 and the object under test 4 is at least 4cm. This distance is determined by calculation or pre-experiment to ensure that they will not interfere with each other when charging at the first level.

[0077] like Figure 5 As shown, the lifting platform 13 includes a scissor lift mechanism 131 and a lifting plate 132 located at the upper end of the scissor lift mechanism 131. A groove 17 is formed on the lifting plate 132, and a rotary motor is fixed to the end of the lifting plate 132. The lifting plate 132 is made of insulating material. Specifically, to reduce electromagnetic interference, the rotating shaft connected to the induction coil 5 can also be made of insulating material, and the distance between the position of the rotary motor and the induction coil 5 is greater than 5 cm.

[0078] Figure 6 Another test fixture 6 structure is shown. This embodiment provides a test fixture including a test unit and a robotic arm 22. The test unit includes a test object 4, a test circuit board 3, a support 23, and an induction coil fixture. The test object 4 and the test circuit board 3 are electrically connected. The test object 4 is an external control device of an implantable medical instrument or its circuit board. The support 23 is provided with multiple mounting parts 24. The induction coil fixture includes a mounting member 27 and an induction coil 5 disposed on the mounting member 27. The induction coil 5 is electrically connected to the test object 4 or the test circuit board 3. The mounting member 27 is detachably connected to the mounting part 24. The robotic arm 22 is used to move the mounting member 27 from one mounting part 24 on the support 23 to another mounting part 24 to adjust the relative spatial position of the induction coil 5 of each test unit.

[0079] In this embodiment, the robotic arm 22 employs a multi-degree-of-freedom mechanism, including degrees of freedom of movement along the X, Y, and Z axes. The robotic arm 22 is located on one side of the testing unit. Each testing unit consists of a test object 4, a test circuit board 3, a support 23, and an induction coil fixture. The test object 4 is the external control device of an implantable medical instrument or its circuit board. The test position of the test object 4 is fixed and always perpendicular to the horizontal plane. The induction coil 5 is perpendicular to the test object 4. The support 23 has a plate-like structure and is perpendicular to the horizontal plane. The multiple mounting parts 24 on the support 23 have different heights, or they can be at different horizontal positions. The induction coil 5 can be fixed to the mounting parts 24 at different positions via mounting pieces 27. When it is necessary to move the mounting piece 27 from one mounting part 24 on the support 23 to another, the robotic arm 22 can be controlled to move the mounting piece 27 on which the induction coil 5 is mounted, changing its position on the support 23, thereby adjusting the relative position of adjacent induction coils 5. The adjustment direction can be horizontal or vertical.

[0080] This embodiment achieves the technical effect of improving testing efficiency and avoiding electromagnetic interference between different test units during the testing process, thereby solving the problem in related technologies that electromagnetic interference can occur when multiple test objects are under test in the same test environment and that manual testing is inefficient.

[0081] The robotic arm 22 may be a robotic arm 22 with a clamping function, which includes a movable arm 221 and a clamping arm 222. The clamping arm 222 is used to clamp and fix the mounting part 27. The movable arm 221 moves to bring the clamping arm 222 close to the mounting part 27, and then controls the clamping arm 222 to clamp and fix the corresponding mounting part 27. Then, the movable arm 221 is controlled to move to separate the mounting part 27 from the mounting part 24 and move it to another mounting part 24 for installation and fixation.

[0082] like Figure 6 As shown, the mounting part 24 is configured as a mounting hole opened on the bracket 23, and the mounting member 27 is movably inserted into the mounting hole. The mounting hole can be configured as an oblong hole, and the part of the mounting member 27 inserted into the oblong hole matches the shape of the oblong hole, thereby improving the stability of its structure. In this embodiment, taking the adjustment of the vertical position of the induction coil 5 as an example, the mounting holes are evenly opened on the bracket 23 along the longitudinal direction.

[0083] like Figure 6 As shown, in order to reduce electromagnetic interference and ensure test accuracy, the distance between the induction coil 5 and the object under test 4 is greater than 4cm. The mounting part 27 and the bracket 23 are both made of insulating material, and the distance between adjacent induction coils 5 is also greater than 4cm.

[0084] like Figure 6 As shown, the mounting component 27 includes a tray and an insert plate located at the end of the tray. The insert plate is movably inserted into the mounting hole, and the induction coil 5 is located on the tray. The clamping arm 222 is used to clamp the tray. The tray is L-shaped and has a horizontal part and a vertical part. The induction coil 5 is placed on the horizontal part, and the insert plate is connected to the vertical part. The horizontal part, the vertical part, and the insert plate are integrally formed. The shape of the insert plate matches the shape of the mounting hole. The horizontal part of the tray is cuboid in shape. The clamping arm 222 of the robotic arm 22 has two relatively movable clamping plates. The horizontal part of the tray is clamped by the mutual approach of the clamping plates.

[0085] like Figure 6 As shown, it also includes a test platform 26, with multiple test units fixed on the test platform 26. To improve testing efficiency, multiple test objects 4 can be tested simultaneously, requiring multiple supports 23, induction coils 5, and test circuit boards 3. The test platform 26 has a cuboid structure, with test units evenly distributed along the length of the test platform 26, and can be configured as 3 or 5 units, etc. The test unit also includes a base 25 fixed on the test platform 26, with the test circuit board 3 and supports 23 both fixed on the base 25. The test object 4 is vertically fixed on the base 25 and electrically connected to the test circuit board 3.

[0086] In order to obtain more accurate test data, the current of the induction coil 5 will be adjusted during the test. As the current of the induction coil 5 increases, the range of its interference will also increase. In order to avoid interference between adjacent induction coils 5, the distance between the induction coils 5 needs to be adjusted in time during the test. Therefore, self-propelled wheels can be installed at the lower end of the base 25, and the distance between two adjacent induction coils 5 can be adjusted by controlling the movement of the wheels.

[0087] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A reliability testing method for an external control device for implantable medical instruments, characterized in that, include: Set the charging power of the object being tested; Adjust the spacing and / or orientation of the induction coils of each object under test according to the current charging power; Control each object under test to perform wireless charging based on the current charging power and the current spacing and / or orientation of the induction coils; Obtain the working parameters of each test object; The method is executed multiple times for multiple rounds of testing, with different charging power and different spacing and / or orientation of the induction coils in each execution, in order to obtain the working parameters of the test object when performing wireless charging with a combination of multiple charging power and multiple spacing and / or orientations. Specifically, the method is executed multiple times to perform multiple rounds of testing, including: Each test object is sequentially set to perform wireless charging at multiple charging levels. The working parameters at each charging level are obtained. The working parameters are compared with the theoretical values ​​to determine whether each charging level passes the test. When it is determined that the current charging level of the tested object has failed the test, the induction coil of the tested object that has failed the test is set to take multiple postures in sequence. Under the multiple postures, the current charging level is maintained to perform wireless charging, and the working parameters under each posture are acquired. By comparing the working parameters with the theoretical value, it is determined again whether the current charging level has passed the test.

2. The reliability testing method according to claim 1, characterized in that, When the current charging level of the tested object is determined to be acceptable for this round of testing, it is switched to the next charging level for the next round of testing.

3. The reliability testing method according to claim 1, characterized in that, After determining that the current charging level has passed this round of testing, maintain the posture that enabled it to pass the test, and switch the tested object to the next charging level to perform wireless charging for the next round of testing.

4. The reliability testing method according to claim 1, characterized in that, If the current charging level fails the test again, the status information of the tested object is obtained to determine whether the working status of the tested object is abnormal.

5. The reliability testing method according to claim 1, characterized in that, When wirelessly charging each object under test at multiple charging levels, the induction coil and the object under test are set to be perpendicular to each other and at a set distance.

6. The reliability testing method according to any one of claims 1-5, characterized in that, The parameters include the total power consumption of the object under test, the emission voltage, and the current flowing through the induction coil.

7. A reliability testing device for an external control device used in implantable medical instruments, characterized in that, include: At least one processor; And a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the at least one processor, the instructions being executed by the at least one processor to cause the at least one processor to perform the reliability testing method for an external control device for an implantable medical device as described in any one of claims 1-6.

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