CN113009268A

CN113009268A - Reliability test method and equipment of external control equipment for implanted medical instrument

Info

Publication number: CN113009268A
Application number: CN202110350751.6A
Authority: CN
Inventors: 王伟明; 李冰; 李路明
Original assignee: Tsinghua University; Beijing Pins Medical Co Ltd
Current assignee: Tsinghua University; Beijing Pins Medical Co Ltd
Priority date: 2021-03-31
Filing date: 2021-03-31
Publication date: 2021-06-22

Abstract

The embodiment of the invention provides a reliability test method and equipment for in-vitro control equipment for an implantable medical instrument, wherein the method comprises the following steps: setting the charging power of a measured object; adjusting the distance and/or the posture of the induction coil of each measured object according to the current charging power; controlling each measured object to perform wireless charging based on the current charging power and the current distance and/or posture of the induction coil; and acquiring the working parameters of each measured object.

Description

Reliability test method and equipment of external control equipment for implanted medical instrument

Technical Field

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

Background

An Implantable Medical Device (IMD) is a Medical Device installed inside the body of a user, and the IMD has a battery, a circuit board (provided with sensors, chips, etc.) inside, and implements a corresponding therapy depending on a set program and operating parameters. The extracorporeal control apparatus is used in conjunction with an implantable medical device for adjusting the operational state of the implantable medical device to meet the therapeutic needs of the user.

In order to ensure the stability and safety of the extracorporeal control apparatus, it is generally necessary to perform a reliability test on the extracorporeal control apparatus. The reliability test is an activity performed for evaluating the functional reliability of a product under a specified expected use environment, and the product needs to be exposed to artificial environmental conditions to perform the action, so as to evaluate the performance of the product under the actual use condition and analyze and research the influence degree of environmental factors and the action mechanism thereof.

An important function of the extracorporeal control apparatus is to wirelessly charge the IMD, which is an indispensable item in reliability testing. According to the hardware principle of wireless charging, the coil outputting the electric energy will generate electromagnetic radiation, and in order to improve the efficiency, a plurality of objects to be tested are usually placed in the same environment for reliability testing, and electromagnetic interference may occur between the objects to be tested, thereby affecting the testing result.

Disclosure of Invention

In view of the above, the present invention provides a method for testing reliability of an extracorporeal control apparatus for an implantable medical apparatus, comprising:

setting the charging power of a measured object;

adjusting the distance and/or the posture of the induction coil of each measured object according to the current charging power;

controlling each measured object to perform wireless charging based on the current charging power and the current distance and/or posture of the induction coil;

and acquiring the working parameters of each measured object.

Optionally, the method is performed multiple times to perform multiple rounds of tests, the charging power is different in each execution process, and the distance and/or posture of the corresponding induction coil is different, so as to obtain the working parameters of the object to be tested when the wireless charging is performed under the conditions of multiple charging powers and multiple combinations of the distances and/or postures.

Optionally, the method, executed multiple times to perform multiple rounds of testing, specifically includes:

the method comprises the steps of setting each tested object in sequence to carry out wireless charging through a plurality of charging gears, obtaining working parameters under each charging gear, judging whether each charging gear passes the current round of test or not by comparing the working parameters with theoretical values, and switching the current charging gear of the tested object to be the next charging gear when the current charging gear of the tested object passes the current round of test to carry out the next round of test.

Optionally, when it is determined that the current charging gear of the measured object does not pass the current round of test, the induction coil of the measured object which does not pass the test is sequentially arranged to take a plurality of postures, the current charging gear is kept in the plurality of postures to execute wireless charging, working parameters in the postures are obtained, and whether the current charging gear passes the current round of test is determined again by comparing the working parameters with theoretical values.

Optionally, after the current charging gear is judged to pass the current round of test again, the posture enabling the current charging gear to pass the test is kept, and the tested object is switched to the next charging gear to execute wireless charging so as to perform the next round of test.

Optionally, when the current charging gear is judged to fail the current test, state information of the measured object is obtained, and whether the working state of the measured object is abnormal is judged.

Optionally, when each object to be measured is sequentially set to perform wireless charging in a plurality of charging gears, the induction coil and the object to be measured are set to be perpendicular to each other and have a set distance.

Optionally, the parameters include a total power consumption value, a transmission voltage value, and a current value flowing through the induction coil of the object to be measured.

Accordingly, the present invention provides a reliability test device of an in vitro control device for an implantable medical device, comprising: at least one processor; and a memory communicatively coupled to the at least one processor; wherein the memory stores instructions executable by the processor, and the instructions are executable by the at least one processor to cause the at least one processor to perform the method for testing the reliability of the extracorporeal control apparatus for an implantable medical device.

According to the reliability testing method and the reliability testing equipment provided by the invention, the charging power of the tested object is firstly set, the distance between each tested object and the posture of each induction coil are correspondingly set, then wireless charging is executed, the working parameters of each tested object are obtained, the electromagnetic interference among the induction coils when the induction coils output electric energy is avoided in the testing process, the reliability of the tested object can be accurately analyzed according to the working parameters, and the batch reliability testing of a plurality of tested objects is realized.

Drawings

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

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

FIG. 2 is a schematic diagram of a preferred reliability testing system according to an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a reliability testing system with an in-vivo simulation device according to an embodiment of the present invention;

FIG. 4 is a block diagram of a test fixture in an embodiment of the present invention;

FIG. 5 is a structural view of a space adjusting mechanism in the embodiment of the present invention;

FIG. 6 is a block diagram of another test fixture in an embodiment of the present invention;

FIG. 7 is a flowchart of a computer-implemented reliability testing method according to an embodiment of the present invention.

Detailed Description

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

Embodiments of the present invention provide a reliability test system for an external control device of an implantable medical device, which may be used to perform reliability tests on an external controller of an implantable medical device such as DBS (deep brain stimulation), VNS (vagal nerve stimulation), SCS (Spinal cord stimulation), and SNM (Sacral nerve stimulation). As shown in fig. 1, the system includes: computer 10, power supply system 7, test fixture 6 and environmental simulation device 1.

The test fixture 6 is provided with a plurality of test units 601, the test units 601 are used for placing the object to be tested 4 and the induction coil 5, and the object to be tested 4 can be an external control device (complete machine) of the implantable medical instrument or a circuit board thereof. In the embodiment of testing the whole machine, the test unit 601 is provided with a bracket or a platform for placing the external control equipment, and the induction coil 5 is directly connected with the whole machine equipment; in the embodiment where the test object is a circuit board, as shown in fig. 2, a test circuit board 3 is further disposed in the test unit 601 for connecting the circuit board under test. The test circuit board 3 is provided with an interface for connecting the tested circuit board and the induction coil 5 and a peripheral circuit for supporting normal operation of the test circuit board, so that the induction coil 5 is connected with the tested circuit board and the tested circuit board is supported to normally operate.

The test fixture 6 may adjust the pitch of each test unit 601 and/or adjust the attitude of the induction coil 5 therein, which refers to the orientation, angle, etc. of the coil. There are several alternative embodiments of the test tool 6, which will be described in detail below. In an alternative embodiment, the test fixture further has a vibration function, and each test unit 601 generates vibration to enable the object to be tested 4 and the induction coil to be in a vibration state for checking whether the electronic components therein are firmly and reliably connected or welded.

The test tool 6 is arranged in the environment simulation device 1, and the environment simulation device 1 is at least used for setting the environment temperature so that the object to be tested 4 is at the set temperature. For example, the ambient temperature may be set at 37 ℃ to simulate the skin surface temperature of a human body. In an optional embodiment, the environment simulation apparatus 1 may further set various environment parameters such as environment humidity, vacuum degree, and the like, so that the object to be measured is in a richer and extreme environment.

The power supply system 7 is used for supplying power to the measured object. The power supply system 7 is connected to all the test units 601, and can simultaneously supply power to all the tested objects 4. In the present embodiment, the power supply system 7 serves as a power source for the object 4 to be tested, so that it can output electric power to the outside.

The computer 10 is used for controlling the object to be measured 4 to perform wireless charging through the induction coil 5, and acquiring charging parameters of the object to be measured. In this embodiment, as shown in fig. 2, the system further includes a data acquisition monitoring system 8 electrically connected to each test unit 601, for respectively performing data acquisition and real-time monitoring on each test unit 601, and transmitting the data to the computer 10. The system further comprises a communication module 9, which is respectively connected with each test unit 601 and the computer 10, and can be used for the computer 10 to communicate with the object 4 to be tested, and the computer 10 can identify the type, the working state and other information of each object 4 to be tested through the communication module 9 and send a control instruction to the computer. The system further comprises a database 11 connected to the computer 10 for storing test data of the reliability test procedure.

The system can enable a tested object to be in different set temperatures to execute wireless charging, the energy is output outwards through the induction coils, the test fixture can adjust the distance between the test units and the posture of the induction coils, electromagnetic interference between the induction coils when the induction coils output electric energy is avoided, a computer acquires the test result of the tested object under the test condition, the reliability of the tested object can be accurately analyzed, and batch reliability test of a plurality of tested objects is realized.

As shown in fig. 7, the computer 10 in the above system performs operations including:

s1, setting the charging power of the object to be measured;

s2, adjusting the distance and/or the posture of the induction coil of each measured object according to the current charging power;

s3, controlling each object to be tested to execute wireless charging based on the current charging power and the current distance and/or posture of the induction coil;

and S4, acquiring the working parameters of each measured object.

In a preferred embodiment, the method is executed for multiple times to perform multiple rounds of tests, the set charging power is different in each execution process, and the corresponding induction coils are different in spacing and/or posture, so as to obtain the working parameters of the object to be tested when wireless charging is performed under the conditions of multiple charging powers and multiple combinations of the spacing and/or posture.

The computer 10 is connected with the test tool 6. The computer 10 is used for setting the charging power of the object 4 to be tested, and controlling the test tool 6 to adjust the distance between the test units 601 and/or adjust the posture of the induction coil according to the current charging power.

The extracorporeal control device is usually configured with a plurality of charging gears, each gear has different charging current and voltage, i.e. different charging power, and the computer 10 can send a command to the object 4 to be measured to switch the charging gears. The electromagnetic radiation intensities and ranges generated by different charging powers are different, for example, the electromagnetic radiation intensity generated by a larger charging power is larger, and the radiation range is wider, in this case, the test fixture 6 needs to adjust the distance of each induction coil 5 far enough and adjust the angle so that the adjacent induction coils 5 do not face each other; conversely, when the charging power is small, a relatively close distance may be set, and so on. For reference, the interval between the adjacent induction coils 5 may be configured to be 4-10cm in various charging stages.

In order to test all charging gears, the computer 10 sequentially sets each object to be tested 4 to perform wireless charging in a plurality of charging gears, obtains working parameters in each charging gear, and judges whether each charging gear passes the test by comparing the working parameters with theoretical values. For reference, the tool parameters include, but are not limited to, a total power consumption value, a transmission voltage value, and a current value flowing through the induction coil 5 of the object 4 to be tested, and in a case where all the parameters are consistent with theoretical values (a certain error range may be allowed), the computer 10 determines that the current charging gear passes the test, otherwise, determines that the current charging gear does not pass the test.

When the computer 10 determines that the current charging gear of the object to be tested 4 passes the test, the current charging gear is switched to the next charging gear, and the distances between the adjacent induction coils 5 under different charging gears are different (that is, the distances between the adjacent test units 601 are different), the charging power of the higher charging gear is larger, the distance between each test unit 601 is larger, and otherwise, the distance is smaller.

For example, the object 4 to be tested has four charging gears, that is, the charging gear is controlled to gradually increase from 1 gear to 4 gears (for one cycle) and then directly return to 1 gear (for the next cycle), during which the computer 10 controls the relevant devices to perform the spacing and posture adjustment of the induction coil 5 and the data monitoring and communication of the whole process according to the requirement or the preset program, and the whole reliability test needs to be performed for a plurality of cycles. Specifically, the method comprises the following steps:

the environment temperature is first set, the environment simulation apparatus 1 may be controlled by the computer 10 to set the temperature to a preset value (e.g., 55 ℃), and the set temperature may be different in different cycles.

The induction coils 5 are set to initial positions (the induction coils 5 are horizontally placed in each test unit, are perpendicular to the measured object 4, and are at least 4cm away from each other), and the distance between adjacent induction coils 5 is set to L0 (for example, L0 ═ 4cm, which is determined by calculation or preliminary experiment and is a distance that never interferes with each other at the time of 1 st charging). The computer 10 communicates with the object 4 to be tested through the communication module 9 to obtain the basic information and the current state, and the state of each object 4 to be tested is normal, so that the experiment can be started.

The computer 10 sends a charging control command to start the charging of the object 4 to be measured in the 1 st gear. The computer 10 obtains parameters such as the total power consumption value, the transmission voltage value, the current value flowing through the induction coil 5 and the like of each measured object 4 through the data acquisition monitoring system 8. Continuously monitoring for a period of time (such as 30 minutes) according to a set sampling rate, comparing the parameters with theoretical values by the computer 10, and judging whether the 1 st grade of each measured object 4 passes the test;

because of the batch test, a part of the tested object may pass the test, and a part of the tested object may not pass the test. If the 1 st charging test of a certain tested object 4 fails, the computer 10 can directly obtain the conclusion that the tested object fails. To avoid false positives, in the preferred embodiment, the computer 10 will retest the test object that failed the current gear test.

Before the retest, the computer 10 acquires the state information of the object 4 to be tested, and determines whether the working state of the object to be tested is abnormal. Specifically, the basic information and the current state of the object to be measured can be acquired through the communication module 9, if the state of the object to be measured is abnormal (no response to communication or other abnormal returns), the computer 10 executes related operations according to a preset program, for example, if the object to be measured 4 is judged to be in a shutdown state, the computer 10 controls the power supply system 7 to power off the object to be measured 4, and then the power supply system is powered on again to restart the object to be measured.

Regarding the retest, specifically, when determining that the current charging gear of the measured object fails the test, the computer 10 sets the induction coil 5 of the measured object 4 that fails the test to take a plurality of postures in sequence, keeps the current charging gear to execute the wireless charging in the plurality of postures, obtains the working parameters in each posture, and determines whether the current charging gear passes the test again by comparing the working parameters with the theoretical values.

As a specific example, the induction coil 5 is rotated from a state perpendicular to the object 4 to be measured in a direction toward the object 4 by 5 degrees at 1 step, rotated 2 times (10 degrees in total), then directly returned to the perpendicular state, held for 5 minutes, then rotated 2 times (10 degrees in total) in the opposite direction, and finally returned to the perpendicular state. The induction coil 5 is kept for 5 minutes and 25 minutes in total every time the induction coil 5 rotates 1 time, and meanwhile the computer 10 controls the data acquisition and monitoring system 8 to obtain 5 groups of data of the measured object 4, including parameters such as a total power consumption value, a transmission voltage value, a current value flowing through the induction coil 5 and the like. The computer 10 compares these parameters with theoretical values and again determines whether the test has passed.

The purpose of the retest is to verify whether the coil attitude in the test unit will cause a test failure condition, i.e., interference from inside the test unit, such as the coil facing a foreign object (connecting wire) or the like, given that the coil pitch of the respective test units is sufficient not to interfere with each other.

If the situation that all the parameters of a certain group can pass the 1 st charging function test exists in the obtained several groups of monitoring parameters of the measured object 4 through the above re-judgment, the posture that the measured object passes the test is kept, and the measured object is switched to the next charging gear to execute the wireless charging. That is, the computer 10 controls the test unit 601 to adjust the attitude 5 of the induction coil to the attitude corresponding to the case where the 1 st charging function passes the test, and keeps the attitude to enter the test of the next gear. If none of the several sets of monitoring parameters of the object 4 to be tested can pass the 1 st-gear charging function test, it is determined that the 1 st-gear charging test of the object 4 to be tested does not pass the current cycle, the object to be tested is stopped to perform the subsequent test of the current cycle, and the test can be restarted in the next cycle.

The computer 10 does not adjust the position and posture of the other test unit 601 except the object 4 to be tested, the other object 4 to be tested still continues to perform the 1 st-gear charging function test, and the monitoring parameters are used for comparing and judging with the theoretical values.

For the tested object 4 passing the 1 st charging test, the computer 10 controls the testing tool 6, adjusts the distance between the testing units 601 so that the distance between the adjacent induction coils 5 is L1 (for example, L1 is 6cm, which is determined by calculation or pre-experiment that the coils in the 2 nd charging position (non-parallel coaxial) never interfere with each other), and the induction coils 5 keep the previous step posture. The computer 10 sends a charging control instruction to enable the object to be measured 4 to start 2-gear charging; the computer 10 obtains parameters such as a power consumption value, a transmitting voltage value, a current value flowing through the induction coil 5 and the like of the measured object 4 through the data acquisition monitoring system 8; the monitoring is continued for a period of time (1 hour) and the computer 10 compares these parameters with the theoretical values for judgment.

Similar to the test from 1 to 2, the computer 10 will test the tested object for 3 and 4 gears, and after completing the test for all gears, complete one cycle, and then can perform the next cycle. As an example, for 3-grade testing, the distance between adjacent induction coils 5 is L3 (for example, L3 ═ 8 cm); for the 4 th test, the distance between adjacent induction coils 5 is L4 (for example, L4 ═ 10 cm).

If the object to be tested is an external control device complete machine, wherein a battery is arranged, the power supply system 7 can also charge the object to be tested 4, so that whether the state of the object to be tested 4 as a charged object is normal can be tested, and the temperature of the environment simulation device 1 can also be set in the process.

In the charged test embodiment, the computer 10 acquires the charging current of the power supply system 7 for each test object 4, and the computer 10 acquires the current basic information and state of the test object 4, mainly focusing on the current battery voltage of the test object 4.

When the power supply charges the rechargeable battery, when the voltage of the battery is in a certain lower range, the charging current is basically constant, and at the moment, whether the charging function is normal can be judged by using the charging current value. According to the current battery voltage, the computer 10 compares the charging current value collected from the power supply system 7 with a theoretical charging current value, and if the charging current value is within an error allowable range, it is determined that the charged function test of the object 4 to be tested passes, otherwise, the charged function test does not pass (for example, the object 4 to be tested may have a charging circuit fault or a battery fault).

In another embodiment, as shown in fig. 3, the test unit 601 is further used for placing an implantable medical device simulator (IPG) for adding an in-vivo device to the reliability test, and the in-vivo device may be configured with a separate battery as its power source, or may be powered by the power supply system 7. After the in-vivo simulation device is added, the system can be used for instruction testing, the computer 10 controls the object to be tested 4 to send a control instruction to the in-vivo simulation device through the induction coil 5, so that the in-vivo simulation device executes an action corresponding to the control instruction, and obtains an action execution result fed back by the in-vivo simulation device and an instruction sending, execution and analysis result fed back by the object to be tested.

The computer 10 obtains the action execution result of the in-vivo simulation device, obtains the instruction sending and execution condition judgment result fed back by the object to be measured 4 through a wired connection mode such as a serial port, determines whether the function of sending the control instruction by the object to be measured 4 is normal or not by judging whether the instruction sending and the execution are consistent, and determines whether the execution judgment function fed back by the object to be measured 4 is normal or not through the actual instruction execution condition.

In the previous embodiment, the object to be measured 4 is wirelessly charged but there is no receiving end, and in the present embodiment, an in-vivo analog device may be used to receive the electric energy output by the object to be measured 4 through the induction coil 5. In the case of the receiving end, the electromagnetic radiation range of the induction coil 5 is reduced, so that the requirements for the spacing and coil orientation of the test unit 601 are relatively relaxed.

The structure of the test fixture 6 will be described with reference to fig. 4-6. Fig. 4 and 5 show a test tool 6 comprising: a motorized translation stage guide rail 12; a plurality of test units 18 disposed on the motorized translation stage guide rail 12, the test units 18 comprising: the space adjusting device comprises an electric control translation table 14 capable of moving on a guide rail 12 of the electric translation table to adjust the space between each test unit 18, a test circuit board 3 arranged on the electric control translation table 14 and a tested object 4 electrically connected with the test circuit board 3, wherein the tested object 4 is an external control device of an implanted medical instrument or a circuit board thereof, a space adjusting mechanism 15 arranged on the electric control translation table 14 and an induction coil 5 arranged on the space adjusting mechanism 15, the induction coil 5 is electrically connected with the tested object 4 or the test circuit board 3, and the space adjusting mechanism 15 is used for adjusting the relative space position of the induction coil 5 of each test unit 18.

In this embodiment, for making the distance between the adjacent test unit 18 adjust more directly perceived, electronic translation platform guide rail 12 adopts horizontal linear guide, and for reducing the occupation of land space of this test fixture, electronic translation platform guide rail 12 is horizontal setting to make automatically controlled translation platform 14 can carry out horizontal migration. The object to be tested 4 is an external control device of the implanted medical instrument or a circuit board thereof, the testing position of the object to be tested 4 is fixed and is always vertical to the horizontal plane, and the induction coil 5 is vertical to the object to be tested 4 in the initial testing state. In order to improve the testing efficiency, the testing unit 18 is provided in plural, and as shown in fig. 4, 5 testing units 18 are sequentially mounted on the electric translation stage guide rail 12 as an example for explanation. The electric control translation stage 14 has a function of automatically walking on the electric translation stage guide rail 12, so that the distance between two adjacent test units 18 is adjusted, the test circuit board 3 is fixed on the electric control translation stage 14 and is provided with an interface for connecting the object to be tested 4 and the induction coil 5 and a peripheral circuit for supporting normal work of the test circuit board, the induction coil 5 is connected with the object to be tested 4, and the normal work of the object to be tested 4 is supported. The space adjusting mechanism 15 is used to adjust the relative spatial position of the induction coil 5 of each test unit 18, including adjusting the height, inclination angle, and the like of the induction coil 5.

This test fixture passes through induction coil 5 and outwards outputs energy, and test fixture has realized through automatically controlled translation platform automatically regulated test unit 18's interval, through the gesture of space adjustment mechanism 15 automatically regulated induction coil 5, avoids each induction coil 5 to have electromagnetic interference when exporting the electric energy each other, improves efficiency of software testing and then has solved among the related art reliability testing of external control equipment and under same test environment a plurality of measurands can take place electromagnetic interference and adopt artifical mode efficiency of software testing low problem.

As shown in fig. 4, the electrically controlled translation stage 14 can slide horizontally on the electric translation stage guide rail 12, and includes a self-walking roller assembly disposed on the electric translation stage guide rail 12 and a mounting platform disposed on the self-walking roller assembly; the test circuit board 3, the object to be tested 4 and the space adjusting mechanism 15 are all arranged on the mounting platform.

Specifically, it should be noted that the electronic control translation stage 14 is composed of a self-walking roller assembly and a mounting platform, the self-walking roller assembly includes a driving device and four walking wheels, the four walking wheels are mountable to ensure the stability of the movement process, and the driving device is used for driving the walking wheels to rotate so as to realize the movement on the electric translation stage guide rail 12. The mounting platform is of a cuboid structure and is fixed on the self-walking roller assembly, and mounting positions for mounting the test circuit board 3, the tested object 4 and the space adjusting mechanism 15 are arranged on the mounting platform. The test circuit board 3 can be embedded on the mounting platform, the object to be tested 4 can be directly butted with the test circuit board 3, and the space adjusting mechanism 15 can be fixed on the mounting platform through screws.

As shown in fig. 4, the space adjusting mechanism 15 includes a lifting platform 13 disposed on the electrically controlled translation platform 14, the induction coil 5 is disposed on the lifting platform 13, and the lifting platform 13 is used for adjusting the relative height position of the induction coil 5 of each adjacent test unit 18.

It should be noted that, the lifting platform 13 may adopt a lifting device in the related art, including a scissor-type lifting mechanism 131, a lead screw lifting mechanism or a cylinder lifting mechanism, and the like, and is not limited herein, in this embodiment, the height of the induction coil 5 is adjusted by the lifting platform 13, and the relative spatial positions of the induction coils of different test units are adjusted, so as to prevent the problem that the different test units generate electromagnetic interference with each other.

As shown in fig. 5, in order to further adjust the posture of the induction coil 5 during the test, the space adjusting mechanism 15 further includes a posture adjusting mechanism provided on the elevating table 13 for adjusting the relative posture of the induction coil 5 of each test unit 16. The posture adjusting mechanism is an inclination angle adjusting component 21, and the induction coil 5 is connected with the output end of the inclination angle adjusting component 21 and used for adjusting the inclination angle of the induction coil 5. The inclination angle adjusting assembly 21 includes a rotating motor 20 fixed on the lifting platform 13, and an output end of the rotating motor 20 is in transmission connection with an end portion of the induction coil 5, so that the induction coil 5 can rotate around its own axis. The induction coil 5 is rotated on the elevating table 13 by the rotating motor 20 to adjust its inclination and orientation.

As a specific example, the induction coil 5 is rotated from a state perpendicular to the object 4 to be measured in a direction toward the object 4 by 5 degrees at 1 step, rotated 2 times (10 degrees in total), then directly returned to the perpendicular state, held for 5 minutes, then rotated 2 times (10 degrees in total) in the opposite direction, and finally returned to the perpendicular state. The induction coil 5 was held for 5 minutes for 25 minutes for every 1 rotation.

As shown in fig. 5, in order to further reduce the volume of the test fixture and reserve a sufficient inclination angle adjustment space for the induction coil 5, the inclination angle adjustment assembly 21 further includes a groove 17 formed at the upper end of the lifting table 13, the induction coil 5 is disposed in the groove 17, and a gap for rotation of the induction coil 5 is formed between the lower surface of the induction coil 5 and the bottom surface of the groove 17; the rotating motor 20 is fixed on the end surface of the lifting platform 13, and the output end of the rotating motor 20 extends into the groove 17 and is connected with the end part of the induction coil 5.

Specifically, it should be noted that the bottom wall of the groove 17 is provided with an arc-shaped slot 16 corresponding to the induction coil 5, and the arc-shaped slot is used for the induction coil 5 to rotate and tilt within a set angle. Taking the induction coil 5 rotating 10 degrees in the forward direction and the reverse direction as an example, the depth of the arc-shaped slot 16 should meet the rotating requirement, and the shape of the arc-shaped slot 16 is similar to that of the induction coil 5. Have protruding 19 on elevating platform 13, the mounting hole has been seted up in the protruding 19, rotate through the bearing in the mounting hole and install the pivot, the first end of pivot and the 5 end connection of induction coil that are located recess 17, the second end is connected with the rotating electrical machines 20 that are located the elevating platform 13 tip, the pivot can set up with induction coil 5 coaxial line, thereby the realization drives induction coil 5 through rotating electrical machines 20 and winds its self axis rotatory certain angle, then realize the regulation to induction coil 5 inclination and orientation.

As shown in fig. 4, in order to reduce electromagnetic interference and ensure the test accuracy, the distance between the induction coil 5 and the object 4 to be tested is at least 4cm, and the distance is determined by calculation or pre-experiment and never interferes with each other when charging at 1 shift.

As shown in fig. 5, the lifting platform 13 includes a scissor lift 131 and a lifting plate 132 disposed at an upper end of the scissor lift 131, the groove 17 is opened on the lifting plate 132, and the rotating motor is fixed at an end of the lifting plate 132; the lift plate 132 is made of an insulating material. Specifically, in order to reduce electromagnetic interference, the rotating shaft connected with the induction coil 5 can also be made of an insulating material, and the distance between the position of the rotating motor and the induction coil 5 is ensured to be larger than 5 cm.

Fig. 6 shows another structure of a test tool 6, which includes a test unit and a mechanical arm 22, wherein the test unit includes a tested object 4, a test circuit board 3, a bracket 23 and an induction coil tool; the object to be tested 4 is electrically connected with the test circuit board 3, the object to be tested 4 is an external control device of the implantable medical instrument or a circuit board thereof, and the bracket 23 is provided with a plurality of mounting parts 24; the induction coil tool comprises a mounting piece 27 and an induction coil 5 arranged on the mounting piece 27, the induction coil 5 is electrically connected with the object to be tested 4 or the test circuit board 3, and the mounting piece 27 is detachably connected with the mounting part 24; the robotic arm 22 is used to move the mounting member 27 from one of the mounts 24 to the other mount 24 on the carriage 23 to adjust the relative spatial position of the induction coils 5 of the respective test cells.

In this embodiment, the robotic arm 22 is a multi-degree-of-freedom motion robotic arm 22 mechanism, including degrees of freedom for motion along the X, Y, and Z axes, with the robotic arm 22 being located on one side of the test cell. Each group of test units consists of a tested object 4, a test circuit board 3, a bracket 23 and an induction coil tool, the tested object 4 is external control equipment of the implanted medical instrument or a circuit board thereof, the test position of the tested object 4 is fixed and is always vertical to the horizontal plane, and the induction coil 5 is vertical to the tested object 4. The bracket 23 is of a plate-shaped structure and is perpendicular to a horizontal plane, the heights of the plurality of mounting parts 24 on the bracket 23 are different, the mounting parts 24 at different positions can be fixed on the induction coil 5 through the mounting parts 27. When the mounting member 27 needs to be moved from one mounting portion 24 to another mounting portion 24 on the support 23, the robot arm 22 can be controlled to move the mounting member 27 on which the induction coil 5 is mounted, so as to change the position of the mounting member 27 on the support 23, thereby realizing the relative position adjustment of the adjacent induction coils 5, wherein the adjustment direction can be a horizontal direction or a vertical direction.

The embodiment realizes the technical effects of improving the testing efficiency and avoiding the mutual electromagnetic interference of different testing units in the testing process, and further solves the problems that in the related art, the reliability test of the in-vitro control equipment can cause the electromagnetic interference of a plurality of tested objects under the same testing environment and the testing efficiency is low by adopting a manual mode.

The robot arm 22 may employ a robot arm 22 having a gripping function, which includes a moving arm 221 and a gripping arm 222, and the gripping arm 222 is used to grip the fixed mount 27. The moving arm 221 is operated to make the holding arm 222 approach the mounting part 27, then the holding arm 222 is controlled to operate to hold and fix the corresponding mounting part 27, and then the moving arm 221 is controlled to operate to make the mounting part 27 and the mounting part 24 separate, and move to another mounting part 24 for mounting and fixing.

As shown in fig. 6, the mounting portion 24 is provided as a mounting hole opened on the bracket 23, the mounting member 27 is movably inserted into the mounting hole, the mounting hole may be provided as a kidney-shaped hole, and a portion of the mounting member 27 inserted into the kidney-shaped hole matches with the shape of the kidney-shaped hole, thereby improving the structural stability thereof. In this embodiment, for example, the vertical position of the induction coil 5 is adjusted, and the mounting holes are uniformly formed on the bracket 23 along the longitudinal direction.

As shown in fig. 6, in order to reduce electromagnetic interference and ensure test accuracy, the distance between the induction coil 5 and the object 4 to be tested is greater than 4cm, the mounting member 27 and the bracket 23 are both made of insulating materials, and the distance between adjacent induction coils 5 is also greater than 4 cm.

As shown in fig. 6, the mounting member 27 includes a supporting plate and an inserting plate disposed at an end portion of the supporting plate, the inserting plate is movably inserted into the mounting hole, and the induction coil 5 is disposed on the supporting plate; the gripping arm 222 is used to grip the pallet. The layer board is L shape setting, and it has horizontal part and vertical part, and induction coil 5 arranges in on the horizontal part, and the picture peg then is connected with the vertical part to horizontal part, vertical part and picture peg integrated into one piece set up, and the shape of picture peg matches with the shape of mounting hole, and the horizontal part of layer board is the cuboid shape, and the centre gripping arm 222 of arm 22 has two relatively movable's splint, thereby the horizontal part of holding the layer board through being close to each other of splint.

As shown in fig. 6, the testing device further includes a testing platform 26, and the testing units are arranged in a plurality and fixed on the testing platform 26. In order to improve the testing efficiency, a plurality of tested objects 4 can be tested at the same time, namely, a plurality of supports 23, induction coils 5 and test circuit boards 3 are needed. The test platform 26 is a rectangular parallelepiped structure, and the test units are uniformly distributed along the length direction of the test platform 26, and may be set to 3 or 5, and so on. The test unit further comprises a base 25 fixed on the test platform 26, the test circuit board 3 and the support 23 are both fixed on the base 25, and the object to be tested 4 is vertically fixed on the base 25 and electrically connected with the test circuit board 3.

In order to obtain more accurate test data, the current of induction coil 5 can be adjusted in the process of testing, along with the increase of current of induction coil 5, the scope of its interference influence also can increase thereupon, in order to avoid producing the interference between adjacent induction coil 5, need in time adjust the interval between induction coil 5 in the testing process, consequently can install the walking wheel that has from the walking function at the lower extreme of base 25, thereby adjust the interval between two adjacent induction coil 5 through controlling the walking wheel removal.

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

Claims

1. A reliability test method of an in-vitro control device for an implantable medical instrument is characterized by comprising the following steps:

setting the charging power of a measured object;

and acquiring the working parameters of each measured object.

2. The reliability test method according to claim 1, wherein the method is performed for multiple rounds of tests, and the charging power is different and the distance and/or posture of the corresponding induction coil is different during each execution, so as to obtain the working parameters of the object to be tested when the wireless charging is performed with multiple charging powers and multiple combinations of the distances and/or postures.

3. The reliability test method according to claim 2, wherein the method being performed a plurality of times for performing a plurality of rounds of testing specifically comprises:

4. The reliability test method according to claim 3, wherein when it is determined that the current charging gear of the object to be tested does not pass the current round of test, the induction coil of the object to be tested which does not pass the test is set to sequentially take a plurality of postures, the current charging gear is maintained in the plurality of postures to perform wireless charging, working parameters in each posture are obtained, and whether the current charging gear passes the current round of test is determined again by comparing the working parameters with theoretical values.

5. The reliability test method according to claim 4, wherein after the current charging gear is judged to pass the current test, the attitude for passing the test is maintained, and the tested object is switched to the next charging gear to perform wireless charging for the next test.

6. The reliability test method according to claim 4, wherein when the current charging gear is judged to fail the current test, the state information of the object to be tested is obtained, and whether the working state of the object to be tested is abnormal or not is judged.

7. The reliability test method according to claim 3, wherein the induction coil and the object to be tested are set to be perpendicular to each other and to have a set distance when each object to be tested is sequentially set to perform wireless charging in a plurality of charging stages.

8. The reliability test method according to any one of claims 1 to 7, wherein the parameters include a total power consumption value, a transmission voltage value, and a current value flowing through the induction coil of the object to be tested.

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