An in vitro simulation device and in vitro simulation method

Abstract

This invention relates to an in vitro simulation device and method, comprising a constant temperature chamber, a simulation medium, a device-under-test (DUT) controller, the DUT, and a data storage and processing system. The constant temperature chamber includes a test device controller, a temperature sensor matrix, and a chamber housing. The simulation medium is located inside the chamber and is used to simulate biological organic tissue. The DUT is located inside the chamber and is at least partially enclosed in the simulation medium, used to convert electrical energy into mechanical energy dissipated within the simulation medium. The probes of the temperature sensor matrix are inserted into the simulation medium. The test device controller is connected to the temperature sensor matrix, the DUT controller, and the data storage and processing system. The test device controller is used to send the temperature signal Te collected by the temperature sensor matrix to the data storage and processing system, and also to control the DUT controller. The method employs the above-described device. The device structure and method of this invention are simple.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and relates to an in-vitro simulation device and an in-vitro simulation method. BACKGROUND

[0002] Generally, for similar renal denervation (RDN) or other methods of making specific action distance biological organic tissues lose activity by using radio frequency or ultrasonic heating, or even using freezing methods, the effective action distance and temperature state measurement and calibration of a given distance are involved, so as to determine the effectiveness, availability and safety of the action instrument or device. Generally, the existing technology uses animal test tissues for slicing, and then directly observes the action results. The skill of the slicing method is professional, and specific qualified professionals must be equipped. The detection accuracy of this method is difficult to quantify, the detection time is long, there is a strong dependence on professional resources, and the cost is high. SUMMARY

[0003] The application aims to solve the problems in the prior art, and provides an in-vitro simulation device and an in-vitro simulation method.

[0004] An in-vitro simulation device comprises a thermostat, a simulation medium, a device under test controller, a device under test and a data storage processing system.

[0005] The thermostat comprises a test device controller, a temperature sensor matrix and a box body, and an absolute value E1 of a deviation of a temperature in the box body from a temperature Ts of an environment in which a biological organic tissue to be simulated is located is not more than a threshold I (the threshold I can be set according to actual requirements, for example, 0.5 DEG C).

[0006] The simulation medium is located in the box body and is used for simulating the biological organic tissue.

[0007] The device under test controller is electrically connected to the device under test and is used for inputting an electrical signal to the device under test. The device under test has different specifications and models to adapt to different simulation conditions.

[0008] The device under test is located in the box body and is at least partially wrapped in the simulation medium, and is used for converting electrical energy into mechanical energy to dissipate in the simulation medium. The positional relationship between the device under test and the simulation medium is the same as the positional relationship between the device under test and the biological organic tissue to be simulated.

[0009] The probe of the temperature sensor matrix is inserted into the simulation medium and is used for measuring the temperature of an action area of the device under test on the surface of the simulation medium.

[0010] The test device controller is connected to the temperature sensor matrix, the device under test (DUT) controller, and the data storage and processing system. The test device controller is used to send the temperature signal Te collected by the temperature sensor matrix to the data storage and processing system. The test device controller is also used to control the DUT controller.

[0011] The data storage and processing system is used to store the temperature signal Te collected by the temperature sensor matrix, or to further process the temperature signal Te collected by the temperature sensor matrix to generate a visual chart.

[0012] The following example illustrates the in vitro simulation device of the present invention:

[0013] The actual process of in vitro simulation is as follows: a power device connected to a control system is installed into a balloon, the balloon is inserted into a narrow channel such as the blood vessel wall, the cooling circulation inside the balloon is activated, the power device is started, and the power device emits energy. Based on the characteristics of energy dissipation in the blood vessel wall, that is, the characteristics of energy absorption by the blood vessel wall, the input energy of the power device is adjusted to control the temperature rise caused by energy absorption by the blood vessel wall. By utilizing the effect of temperature at a specific depth in the blood vessel wall, certain specific changes in the blood vessel wall tissue can be achieved. In this case, the simulation medium in the in vitro simulation device is equivalent to the blood vessel wall, the device under test is equivalent to the power device, the temperature of the chamber is 37°C, and the controller of the device under test is equivalent to the control system.

[0014] As a preferred technical solution:

[0015] As described above, the in vitro simulation device includes a temperature sensor matrix comprising a limiting plate; multiple limiting tubes are vertically mounted on the upper surface of the limiting plate; a protective tube is inserted inside each limiting tube, the lower end of which is located below the limiting plate and is a single inclined surface, an inwardly concave curved surface, an outwardly convex curved surface, or a double-sided mirror combination of these three curved surfaces, or any combination of two shapes; a miniature temperature sensor is inserted inside each protective tube, the main body of which is a rod-shaped structure, and the probe at the lower end is a spherical structure that protrudes from inside the protective tube; the components of the temperature sensor matrix are connected by adhesive.

[0016] As described above, in an in vitro simulation device, the multiple limiting tubes are arranged in a rectangular array, a triangular array, a single-head three-dimensional spiral array, or a multi-head three-dimensional spiral array. When using a spiral structure, a half structure is adopted, with two semi-cylinders fastened together, and the sensors are arranged spirally along the cylindrical axis.

[0017] As described above, the in vitro simulation device comprises a base and a cover plate. The base has a cavity, and the cover plate covers the top of the base. The simulation medium and the device under test (DUT) are placed within the cavity of the base. The simulation medium is supported by a simulation medium support located within the cavity of the base. The simulation medium support is supported by a support adjusting screw penetrating the bottom wall of the base. The DUT is a rod-shaped structure, placed horizontally, with both ends protruding from strip-shaped holes on the side wall of the base. These strip-shaped holes guide the DUT's vertical movement. The limiting plate of the temperature sensor matrix is ​​located above the DUT and is clamped by the base and the cover plate. The base and the cover plate are connected by clamping screws.

[0018] As described above, the in vitro simulation device also includes a constant temperature liquid tank, a peristaltic pump I, and a constant temperature liquid medium pipeline.

[0019] The test apparatus controller, constant temperature liquid tank, and peristaltic pump I are located outside the chamber; part of the constant temperature liquid medium pipeline is located inside the base of the chamber, and the other part is located outside the chamber; the two ends of the constant temperature liquid medium pipeline are connected to the inlet and outlet of the constant temperature liquid tank, respectively.

[0020] The constant temperature liquid tank is equipped with a liquid temperature control device, which is electrically connected to the test device controller; the peristaltic pump I is installed on the constant temperature liquid medium pipeline, and the motor of the peristaltic pump I is electrically connected to the test device controller.

[0021] The in vitro simulation device described above further includes a collection box, a coolant storage tank, coolant pipelines, and a peristaltic pump II;

[0022] The collection box and coolant storage tank are both located outside the enclosure and are connected to the inside of the device under test via coolant pipes; the peristaltic pump II is located outside the enclosure and is installed on the coolant pipe connecting the coolant storage tank and the inside of the device under test.

[0023] The motor of peristaltic pump II is electrically connected to the controller of the device under test;

[0024] The device under test (DUT) has an internal temperature sensor. The temperature sensor is connected to the test device controller via the DUT controller, or the temperature sensor is directly connected to the test device controller. The temperature signal is collected by the internal temperature sensor of the DUT, and the peristaltic pump motor II is controlled by the DUT controller to adjust the flow rate, thereby controlling the temperature of the DUT.

[0025] The present invention also provides an in vitro simulation method using an in vitro simulation device as described above, the process of which is as follows:

[0026] (1) The test device controller controls the liquid temperature control device in the constant temperature liquid tank and the motor of peristaltic pump I to start;

[0027] (2) Perform constant temperature circulation;

[0028] (3) The scanning period of the test device controller for comparison signals such as temperature is variable and controlled by the test device controller program. When the difference is large, the scanning period is long, and when the difference is small, the scanning period is correspondingly shorter. The test device controller judges whether the absolute value E1 of the deviation between the temperature signal Te collected by the temperature sensor matrix and the temperature Ts of the environment where the simulated biological organic tissue is located is greater than the threshold I (the threshold I can be set according to actual needs, such as 0.5℃), and at the same time judges whether the isothermal cycle time is greater than the threshold II (the threshold II can be set according to actual needs, such as 45min). If E1 is greater than the threshold I and the isothermal cycle time is greater than the threshold II, an alarm will pop up and the machine will stop. If E1 is greater than the threshold I and the isothermal cycle time is less than or equal to the threshold II, the process will return to step (2). In other cases, the process will proceed to the next step.

[0029] (4) The test device controller starts the motor of peristaltic pump II through the controller of the device under test;

[0030] (5) The test device controller controls the device under test controller to input a voltage signal that varies with time in a sinusoidal manner to the device under test. The voltage signal ranges from 0.5 to 5V, and the sinusoidal frequency ranges from 4 to 12MHz. If the device under test controller cannot directly input the target intensity signal to the device under test, a signal amplifier needs to be installed between the device under test and the device under test controller to amplify the signal output by the device under test controller before sending it to the device under test. After receiving the voltage signal, the device under test converts electrical energy into mechanical energy and dissipates it in the simulation medium, causing the simulation medium to produce changes in medium properties due to temperature changes.

[0031] (6) The test device controller sends the temperature signal Te collected by the temperature sensor matrix to the data storage and processing system at the set collection frequency period Tf (e.g., 0.5 seconds / time);

[0032] (7) The test device controller simultaneously determines: ① whether the surface temperature of the device under test monitored by the internal temperature sensor is higher than the temperature Ts of the environment where the simulated biological organic tissue is located; ② whether the absolute value E2 of the deviation between the temperature signal Te collected by the temperature sensor matrix and the simulation required temperature Td (i.e. the simulation target temperature) is greater than the threshold III (the threshold III can be set according to actual needs, preferably 0.2-1.5 degrees Celsius); ③ whether the time the device under test acts on the simulation medium is greater than the threshold IV (the threshold IV can be set according to actual needs, for example, preferably 30 seconds-80 seconds);

[0033] If both ② and ③ are true, an alarm will pop up and the machine will be shut down;

[0034] If ② is negative and ③ is positive, then the machine should be shut down.

[0035] If ① is yes, ② is yes, and ③ is no, then the speed of the motor of the peristaltic pump II is increased by the controller of the device under test. At the same time, when the temperature signal Te collected by the temperature sensor matrix is ​​greater than the simulation required temperature Td, the voltage signal input by the controller of the device under test to the device under test is decreased. When the temperature signal Te collected by the temperature sensor matrix is ​​less than the simulation required temperature Td, the voltage signal input by the controller of the device under test to the device under test is increased, and the process returns to step (6).

[0036] If ① is no, ② is yes, and ③ is no, then when the temperature signal Te collected by the temperature sensor matrix is ​​greater than the simulation required temperature Td, the voltage signal input from the device under test controller to the device under test is reduced; when the temperature signal Te collected by the temperature sensor matrix is ​​less than the simulation required temperature Td, the voltage signal input from the device under test controller to the device under test is increased, and the process returns to step (6).

[0037] If ① is yes, ② is no, and ③ is no, then increase the speed of the motor of the peristaltic pump II through the controller of the device under test, and return to step (6);

[0038] If ① is no, ② is no, and ③ is no, then return to step (6).

[0039] Beneficial effects

[0040] This invention provides an in vitro simulation device that uses an array of multiple temperature sensors for easy installation and disassembly. Through optimized arrangement, it achieves measurement distance accuracy smaller than the physical size of the device, accurately acquiring the temperature field of the simulated medium during the operation of the device under test. This allows for effective and rapid study of the temperature change characteristics of the simulated medium during the operation of the device under test. The device employs isothermal cycling to keep itself at the same temperature as the simulated state, reducing errors caused by temperature and making the simulation more accurate.

[0041] This invention provides an in vitro simulation method that, through automatic control of the simulation process, not only realizes the actual working process of the component under test (DUT) but also simulates its performance in a simulation medium. By setting key parameter thresholds, it can support simulation of similar working scenarios, particularly in the processing and visualization of temperature field signals. This allows for direct reading of the DUT's performance characteristics, guiding its development and research, the determination and calibration of working parameters, and the inspection of factory performance. Furthermore, by controlling and calibrating the precision of the measuring devices used in the apparatus, high-precision simulation results can be obtained. This reduces the number of in vivo tests, improves the development efficiency of working components, and reduces the development cost and cycle time of instruments. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of the device connection of the present invention;

[0043] Figure 2 This is a schematic diagram of the three-dimensional structure of the box body of the present invention;

[0044] Figure 3 This is a top view of the box structure of the present invention;

[0045] Figure 4 for Figure 3 Schematic diagram of the cross-sectional structure of the middle box along the AA direction;

[0046] Figure 5 This is a schematic diagram of the internal structure of the housing of the present invention;

[0047] Figure 6 This is a schematic diagram of the internal structure of the housing of the present invention;

[0048] Figure 7 This is a schematic diagram of the connection structure between the miniature temperature sensor and the limiting plate of the present invention;

[0049] Figure 8 This is a schematic diagram of the single-head three-dimensional spiral array arrangement of the temperature sensor matrix of the present invention;

[0050] Figure 9 This is a schematic diagram of the dual-head three-dimensional spiral array arrangement of the temperature sensor matrix of the present invention;

[0051] Figure 10 The diagram shows the connection structure between the protective tube and the miniature temperature sensor. In (a), the lower end of the protective tube is a single inclined surface; in (b), the lower end of the protective tube is a concave curved surface; in (c), the lower end of the protective tube is a convex curved surface; in (d), the lower end of the protective tube is a double-sided mirror image of a concave curved surface; in (e), the lower end of the protective tube is a double-sided mirror image of a single inclined surface; and in (f), the lower end of the protective tube is a double-sided mirror image of a convex curved surface.

[0052] Among them: 1-Support adjustment screw, 2-Simulation medium support, 3-Temperature sensor matrix, 4-Clamping screw, 5-Cover plate, 6-Device under test, 7-Base, 8-Constant temperature liquid medium pipeline, 9-Simulation medium, 10-Limiting plate, 11-Miniature temperature sensor, 12-Limiting tube, 13-Protective tube, 14-Fixing adhesive. Detailed Implementation

[0053] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0054] An in vitro simulation device, such as Figure 1As shown, it includes a constant temperature chamber, simulation medium 9, device under test 6, device under test controller, collection box, coolant storage tank, coolant pipeline, peristaltic pump II and data storage and processing system;

[0055] The constant temperature chamber includes a test device controller, a temperature sensor matrix 3, a chamber body, a constant temperature liquid tank, a peristaltic pump I, and a constant temperature liquid medium pipeline 8;

[0056] like Figures 2 to 6 As shown, the chamber is composed of a base 7 and a cover plate 5 connected by clamping screws 4; the base 7 has a cavity inside, and the cover plate 5 covers the top of the base 7. The absolute value E1 of the temperature deviation between the temperature inside the chamber and the temperature Ts of the environment where the simulated biological organic tissue is located does not exceed the threshold I (the threshold I can be set according to actual needs, for example, 0.5℃).

[0057] The constant temperature liquid tank is located outside the chamber, and a liquid temperature control device is installed inside it. The liquid temperature control device is electrically connected to the test device controller outside the chamber.

[0058] A portion of the constant temperature liquid medium pipeline 8 is located inside the base 7 of the box, and the other portion is located outside the box. The two ends of the constant temperature liquid medium pipeline 8 are connected to the inlet and outlet of the constant temperature liquid box, respectively.

[0059] Peristaltic pump I is located outside the chamber and is installed on the constant temperature liquid medium pipeline 8. The motor of peristaltic pump I is electrically connected to the controller of the test device.

[0060] like Figures 7 to 9 As shown, the temperature sensor matrix 3 includes a limiting plate 10; the limiting plate 10 is located above the device under test 6 and is held by the base 7 and cover plate 5 of the housing; multiple limiting tubes 12 are vertically mounted on the upper surface of the limiting plate 10, and the multiple limiting tubes 12 are arranged in a rectangular array, a triangular array, a single-head three-dimensional spiral array, or a multi-head three-dimensional spiral array; a protective tube 13 is inserted into each limiting tube 12, and the lower end of the protective tube 13 is located below the limiting plate 10 and is a single inclined surface, an inwardly concave curved surface, an outwardly convex curved surface, or a double-sided mirror combination of these three curved surfaces or any combination of two shapes (such as...). Figure 10 As shown), each protective tube 13 is fitted with a miniature temperature sensor 11. The main body of the miniature temperature sensor 11 is a rod-shaped structure, and the probe at the lower end is a spherical structure that protrudes from the protective tube 13. The components of the temperature sensor matrix 3 are connected by adhesive 14. The probe of the temperature sensor matrix 3 is inserted into the simulation medium 9 and is used to measure the temperature of the area of ​​the device under test 6 on the surface of the simulation medium 9.

[0061] The simulation medium 9 is placed in the cavity of the base 7 of the box and is supported by the simulation medium support 2 located in the cavity of the base 7. The simulation medium support 2 is supported by the support adjustment screw 1 that penetrates the bottom wall of the base 7. The simulation medium 9 is used to simulate biological organic tissue.

[0062] The device under test (DUT) 6 is a rod-shaped structure placed horizontally inside the cavity of the base 7, with both ends protruding from strip-shaped holes on the side wall of the base 7. The strip-shaped holes are used to guide the DUT 6 to move up and down. The DUT 6 is at least partially enclosed in the simulation medium 9, which is used to convert electrical energy into mechanical energy and dissipate it in the simulation medium 9. The positional relationship between the DUT 6 and the simulation medium 9 is the same as the positional relationship between the DUT 6 and the simulated biological organic tissue. The DUT 6 is equipped with a temperature sensor, which is connected to the test device controller through the DUT controller or directly to the test device controller.

[0063] Both the collection box and the coolant storage tank are located outside the enclosure and are connected to the inside of the device under test 6 via coolant pipes;

[0064] The peristaltic pump II is located outside the enclosure and is installed on the coolant pipe connecting the coolant storage tank and the inside of the device under test 6. The motor of the peristaltic pump II is electrically connected to the controller of the device under test.

[0065] The device under test (DUT) controller is electrically connected to the DUT 6 and is used to input electrical signals to the DUT 6.

[0066] The test device controller is connected to the temperature sensor matrix 3, the device under test controller, and the data storage and processing system. The test device controller is used to send the temperature signal Te collected by the temperature sensor matrix 3 to the data storage and processing system. The test device controller is also used to control the device under test controller.

[0067] The data storage and processing system is used to store the temperature signal Te collected by the temperature sensor matrix 3, or to further process the temperature signal Te collected by the temperature sensor matrix 3 to generate a visual chart.

[0068] An in vitro simulation method based on the above-mentioned in vitro simulation device, the specific process of which is as follows:

[0069] (1) The test device controller controls the liquid temperature control device in the constant temperature liquid tank and the motor of peristaltic pump I to start;

[0070] (2) Perform constant temperature circulation;

[0071] (3) The test device controller determines whether the absolute value E1 of the deviation between Te and Ts is greater than the threshold I, and at the same time determines whether the constant temperature cycle time is greater than the threshold II (the threshold II can be set according to actual needs, such as 45 min). If E1 is greater than the threshold I and the constant temperature cycle time is greater than the threshold II, an alarm will pop up and the machine will stop. If E1 is greater than the threshold I and the constant temperature cycle time is less than or equal to the threshold II, return to step (2). In other cases, proceed to the next step.

[0072] (4) The test device controller starts the motor of peristaltic pump II through the controller of the device under test;

[0073] (5) The test device controller controls the device under test controller to input a voltage signal that varies with time in a sinusoidal manner to the device under test. After receiving the voltage signal, the device under test converts electrical energy into mechanical energy and dissipates it in the simulation medium.

[0074] (6) The test device controller sends Te to the data storage and processing system at the set acquisition frequency period Tf (e.g., 0.5 seconds / time);

[0075] (7) The test device controller simultaneously determines: ① whether the surface temperature of the device under test monitored by the internal temperature sensor of the device under test is higher than Ts; ② whether the absolute value E2 of the deviation between Te and the simulation required temperature Td is greater than the threshold III (the threshold III can be set according to actual needs, preferably 0.2-1.5 degrees Celsius); ③ whether the time the device under test acts on the simulation medium is greater than the threshold IV (the threshold IV can be set according to actual needs, for example, preferably 30 seconds-80 seconds);

[0076] If both ② and ③ are true, an alarm will pop up and the machine will be shut down;

[0077] If ② is negative and ③ is positive, then the machine should be shut down.

[0078] If ① is yes, ② is yes, and ③ is no, then the speed of the motor of the peristaltic pump II is increased by the controller of the device under test. At the same time, when Te is greater than Td, the voltage signal input from the controller of the device under test to the device under test is decreased, and when Te is less than Td, the voltage signal input from the controller of the device under test to the device under test is increased, and the process returns to step (6).

[0079] If ① is no, ② is yes, and ③ is no, then when Te is greater than Td, the voltage signal input from the controller of the device under test to the device under test is reduced, and when Te is less than Td, the voltage signal input from the controller of the device under test to the device under test is increased, and the process returns to step (6).

[0080] If ① is yes, ② is no, and ③ is no, then increase the speed of the motor of the peristaltic pump II through the controller of the device under test, and return to step (6);

[0081] If ① is no, ② is no, and ③ is no, then return to step (6).

Claims

1. An in-vitro simulation device, characterized in that, The constant temperature box comprises a test device controller, a temperature sensor matrix, and a box body, an absolute value E1 of a deviation of a temperature in the box body from a temperature Ts of an environment in which a simulated biological organic tissue is located is not more than a threshold value I, and the constant temperature box further comprises a simulation medium, a device under test controller, and a device under test. The simulation medium is located in the box body and is used for simulating the biological organic tissue. The device under test controller is electrically connected with the device under test and is used for inputting an electrical signal to the device under test. The device under test is located in the box body and is at least partially wrapped in the simulation medium, and is used for converting electrical energy into mechanical energy and dissipating the mechanical energy in the simulation medium. The device under test and the simulation medium have a same positional relationship as the device under test and the simulated biological organic tissue. The probe of the temperature sensor matrix is inserted into the simulation medium and is used for measuring a temperature of an action region of the device under test on a surface of the simulation medium. The test device controller is connected with the temperature sensor matrix, the device under test controller, and a data storage processing system. The data storage processing system is used for storing the temperature signal Te or further processing the temperature signal Te to generate a visual chart. The temperature sensor matrix comprises a limiting plate, a plurality of limiting tubes are vertically installed on an upper surface of the limiting plate, a protector is inserted into each limiting tube, a lower end of the protector is located below the limiting plate and has a single inclined surface, an inner concave surface, an outer convex surface, or a combination of the three types of surfaces or a combination of two types of surfaces, a micro temperature sensor is inserted into each protector, a main body of the micro temperature sensor has a rod structure, a probe at a lower end of the main body has a spherical structure and is exposed from the protector, and the components of the temperature sensor matrix are connected through fixing glue. The plurality of limiting tubes are arranged in a rectangular matrix, a triangular matrix, a single-head three-dimensional spiral array, or a multi-head three-dimensional spiral array.

2. An in-vitro simulation device according to claim 1, wherein, The box body comprises a base and a cover plate, the base is provided with a cavity, the cover plate covers a top of the base, the simulation medium and the device under test are placed in the cavity of the base, and the simulation medium is supported by a simulation medium support in the cavity of the base.

3. An in-vitro simulation apparatus according to claim 1, wherein The simulation medium support is supported by a support adjusting screw penetrating a bottom wall of the base, the device under test has a rod structure and is horizontally placed, two ends of the device under test are exposed from a strip-shaped hole arranged on a side wall of the base and used for guiding the device under test to move up and down, the limiting plate of the temperature sensor matrix is located above the device under test and is clamped by the base and the cover plate, and the base and the cover plate are connected through a pressing screw. The constant temperature box further comprises a constant temperature liquid tank, a peristaltic pump I, and a constant temperature liquid medium pipeline.

4. An in-vitro simulation device according to claim 3, wherein, The test device controller, the constant temperature liquid tank, and the peristaltic pump I are located outside the box body, one part of the constant temperature liquid medium pipeline is located in the base of the box body, and the other part is located outside the box body, and two ends of the constant temperature liquid medium pipeline are connected with an inlet and an outlet of the constant temperature liquid tank, respectively. The constant temperature liquid tank is provided with a liquid temperature control device, the liquid temperature control device is electrically connected with the test device controller, the peristaltic pump I is installed on the constant temperature liquid medium pipeline, and a motor of the peristaltic pump I is electrically connected with the test device controller. ​ 5. An in-vitro simulation apparatus according to claim 4, wherein, The in-vitro simulation device further comprises a collecting box, a cooling liquid storage tank, a cooling liquid pipeline, and a peristaltic pump II; The collecting box and the cooling liquid storage tank are both located outside the box body and are both in communication with the inside of the device under test through the cooling liquid pipeline; the peristaltic pump II is located outside the box body and is installed on the cooling liquid pipeline that is in communication with the cooling liquid storage tank and the inside of the device under test; The motor of the peristaltic pump II is electrically connected with the controller of the device under test; The inside of the device under test is provided with a temperature sensor, which is connected with the controller of the test device through the controller of the device under test, or is directly connected with the controller of the test device.

6. An in-vitro simulation method using an in-vitro simulation device according to claim 5, characterized in that, The process is as follows: (1) The controller of the test device controls the liquid temperature control device in the constant-temperature liquid tank and the motor of the peristaltic pump I to start; (2) Constant-temperature circulation is performed; (3) The controller of the test device judges whether the absolute value E1 of the deviation of Te and Ts is greater than a threshold I, and simultaneously judges whether the constant-temperature circulation time is greater than a threshold II; if E1 is greater than the threshold I and the constant-temperature circulation time is greater than the threshold II, an alarm is popped up and the device is stopped; if E1 is greater than the threshold I and the constant-temperature circulation time is less than or equal to the threshold II, step (2) is returned to; otherwise, the next step is entered; (4) The controller of the test device starts the motor of the peristaltic pump II through the controller of the device under test; (5) The controller of the test device controls the controller of the device under test to input a voltage signal that varies with time according to a sine rule to the device under test; after receiving the voltage signal, the device under test converts the electric energy into mechanical energy and dissipates it in the simulation medium; (6) The controller of the test device sends Te to a data storage processing system at a set collection frequency period Tf; (7) The controller of the test device simultaneously judges: ① whether the surface temperature of the device under test monitored by the temperature sensor in the device under test is higher than Ts; ② whether the absolute value E2 of the deviation of Te and a simulation demand temperature Td is greater than a threshold III; ③ whether the time of the device under test acting on the simulation medium is greater than a threshold IV; if both ② and ③ are yes, an alarm is popped up and the device is stopped; if ② is no and ③ is yes, the device is stopped; if ① is yes, ② is yes, and ③ is no, the speed of the motor of the peristaltic pump II is increased through the controller of the device under test, and simultaneously, the voltage signal input by the controller of the device under test to the device under test is decreased when Te is greater than Td, and is increased when Te is less than Td, and step (6) is returned to; if ① is no, ② is yes, and ③ is no, the voltage signal input by the controller of the device under test to the device under test is decreased when Te is greater than Td, and is increased when Te is less than Td, and step (6) is returned to; if ① is yes, ② is no, and ③ is no, the speed of the motor of the peristaltic pump II is increased through the controller of the device under test, and step (6) is returned to; if ① is no, ② is no, and ③ is no, step (6) is returned to. ​

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