Heart valve steady state leakage and forward flow testing device

Abstract

The invention discloses a steady-state leakage and forward flow testing device for a heart valve, and relates to the technical field of medical instrument inspection. The device comprises a reservoir, a pipeline, and a driving device, a regulating valve, a front-end flow meter, a front-end valve mounting channel and a rear-end valve mounting channel which are sequentially mounted on the pipeline, and the two ends of the pipeline are communicated with the reservoir. The heating and temperature control system ensures that the liquid temperature meets the requirement of a new edition standard, the valve installation channel with the inner diameter of 70 mm is suitable for a large-size mitral valve, and differential pressure sensor interfaces are arranged in front of and behind the valve ring of the artificial heart valve, so that the requirement of the new standard for the position of a sensor is met; according to the device, flexible selection of pressure values under different blood pressure states is achieved by adjusting the rotating speed of a driving device (a magnetic pump), accurate measurement and automation of the leakage amount are achieved through a high-precision flow meter, and the whole design aims at improving the accuracy and repeatability of testing and ensuring the quality and safety of an artificial heart valve.

Description

Technical Field

[0001] The invention belongs to the technical field of medical device inspection, and in particular relates to a heart valve steady-state leakage and forward flow testing device. Background Art

[0002] Artificial heart valves are medical devices that can be implanted in the heart to replace heart valves and enable blood to flow in one direction. They are mainly used for artificial heart valve replacement when the heart valve disease is serious and valve separation surgery or repair surgery cannot be used to restore or improve valve function. Artificial heart valves are Class III medical devices that are subject to national key supervision and have a high risk level. They must be strictly controlled to ensure their safety and effectiveness.

[0003] In the testing of artificial heart valves, steady-state leakage and forward flow tests are very important test items. In the industry standard GB / T 12279.1-2024 "Cardiovascular Implants Artificial Heart Valves Part 1: General Requirements", a normative overview of the steady-state leakage and forward flow test methods is given, but no specific test equipment is given.

[0004] At present, the existing heart valve steady-state leakage and forward flow test equipment is mainly designed based on the old version of the industry standard GB12279-2008 "Cardiovascular Implant Artificial Heart Valves", which does not meet the new version of the industry standard GB / T12279.1-2024 "Cardiovascular Implant Artificial Heart Valves Part 1: General Requirements" and has the following shortcomings: 1. The existing equipment has no heating device and does not meet the 37℃±2℃ requirement in the new standard.

[0005] 2. The existing equipment is only provided with a valve installation channel with a straight tube of 35 mm inner diameter, and no straight tube with a larger diameter is provided for valves larger than 35 mm.

[0006] 3. The existing equipment only has one pressure difference sensor interface in front and behind the artificial heart valve ring, which does not meet the requirements of the new standard that the pressure difference sensor interface should be located one pipe diameter upstream and three pipe diameters downstream of the artificial heart valve ring plane.

[0007] 4. The pressure values ​​of existing equipment are fixed at 40mmHg, 80mmHg, 120mmHg, 160mmHg and 200mmHg, which does not meet the flexible selection of pressure values ​​for adults and minors under different blood pressure conditions in the new standard.

[0008] 5. The test data obtained by manual weighing has large errors, resulting in low accuracy of the results.

[0009] The steady-state leakage and forward flow performance of artificial heart valves are very important and directly related to the quality of clinical treatment and the life safety of patients. Therefore, designing an accurate and reliable test device to detect and evaluate the quality of artificial heart valves has great practical application value and significance.

[0010] Based on the above practical needs, designing a heart valve steady-state leakage and forward flow test device that is easy to operate, has good stability, high test result accuracy, and good repeatability is a problem that needs to be solved urgently. Summary of the invention

[0011] The purpose of the present invention is to provide a heart valve steady-state leakage and forward flow testing device, which ensures that the liquid temperature is maintained at 37°C±2°C through a heating and temperature control system, adds a valve installation channel with an inner diameter of 70mm to accommodate large-sized mitral valves, and sets a pressure difference sensor interface before and after the artificial heart valve ring to meet the requirements of the new standard.

[0012] In order to solve the above technical problems, the present invention is achieved through the following technical solutions: The present invention is a device for testing steady-state leakage and forward flow of a heart valve, comprising a water reservoir, a pipeline, and a driving device, a regulating valve, a front-end flow meter, a front-end valve installation channel, and a rear-end valve installation channel sequentially installed on the pipeline; both ends of the pipeline are connected to the water reservoir; a three-way ball valve is installed on the pipeline between the rear-end valve installation channel and the water reservoir; a branch pipeline is installed on the third end of the three-way ball valve; a rear-end flow meter is installed on the branch pipeline; the front-end valve installation channel and the rear-end valve installation channel are connected to each other. Connected by quick buckles; a test piece fixture for clamping and installing the aortic valve / mitral valve is clamped and installed between the front-end valve installation channel and the rear-end valve installation channel; a pressure gauge is installed on the front-end valve installation channel; a differential pressure sensor interface A is arranged at one times the inner diameter of the test piece fixture on the front-end valve installation channel; a differential pressure sensor interface B is arranged at three times the inner diameter of the test piece fixture on the rear-end valve installation channel; a differential pressure gauge is connected and installed between the differential pressure sensor interface A and the differential pressure sensor interface B.

[0013] As a preferred technical solution of the present invention, the test piece fixture for clamping and installing the aortic valve includes an aortic valve fixing ring, an aortic valve inflow end clamp and an aortic valve outflow end clamp for use together; the aortic valve fixing ring, the aortic valve inflow end clamp and the aortic valve outflow end clamp are all annular structures; the aortic valve is fixedly installed on the inner ring surface of the aortic valve fixing ring; the aortic valve fixing ring and the aortic valve inflow end clamp are provided with a first step surface that cooperates with each other; the aortic valve outflow end clamp is provided with a second step surface that cooperates with the aortic valve fixing ring; the straight tube inner diameter of the front end valve installation channel and the straight tube inner diameter of the rear end valve installation channel are both 35 mm.

[0014] As a preferred technical solution of the present invention, the test piece tooling for clamping and installing the mitral valve includes a mitral valve fixing ring, a mitral valve inflow end clamp and a mitral valve outflow end clamp used in conjunction with each other; the mitral valve fixing ring, the mitral valve inflow end clamp and the mitral valve outflow end clamp are all annular structures; the mitral valve is fixedly installed on the inner ring surface of the mitral valve fixing ring; the mitral valve fixing ring and the mitral valve outflow end clamp are provided with a third step surface that cooperates with each other; the mitral valve inflow end clamp is provided with a fourth step surface that cooperates with the mitral valve fixing ring; the straight tube inner diameter of the front end valve installation channel and the straight tube inner diameter of the rear end valve installation channel are both 70 mm.

[0015] As a preferred technical solution of the present invention, a gasket A is provided between the test piece fixture and the butt end of the front valve installation channel; a gasket B is provided between the test piece fixture and the butt end of the rear valve installation channel.

[0016] As a preferred technical solution of the present invention, the water reservoir is installed with a heating device; the heating device includes an electric heating rod, a temperature controller and a temperature sensor.

[0017] As a preferred technical solution of the present invention, the differential pressure sensor interface A and the differential pressure sensor interface B are both Luer connectors.

[0018] As a preferred technical solution of the present invention, the driving device is a magnetic pump.

[0019] As a preferred technical solution of the present invention, it also includes a first frame and a second frame; the water reservoir is installed on the middle frame of the first frame; the first carrier plate and the second carrier plate are linearly slidably installed on the bottom frame of the second frame; the front end valve mounting channel is installed and fixed on the first carrier plate; the rear end valve mounting channel is installed and fixed on the second carrier plate.

[0020] As a preferred technical solution of the present invention, a compliance chamber is installed on the pipeline between the driving device and the regulating valve to stabilize the pressure and flow.

[0021] As a preferred technical solution of the present invention, it also includes a liquid storage barrel, which is placed below the end of the branch pipeline.

[0022] The present invention has the following beneficial effects: 1. The present invention uses a heating and temperature control device to maintain the liquid temperature at 37°C ± 2°C, meeting the requirements of the new version of the standard, making the in vitro test environment closer to human body temperature, ensuring the full deployment of the artificial heart valve frame, and making related test data more accurate.

[0023] 2. The present invention meets the requirement of the standard that "a straight tube with a larger diameter is provided for valves larger than 35 mm" by adding a valve installation channel with an inner diameter of 70 mm. The 70 mm valve installation channel is mainly suitable for large-sized mitral valves, and expands the test objects of the equipment from the aortic valve to the aortic valve and the mitral valve.

[0024] 3. The present invention meets the requirements of the new standard by providing a pressure difference sensor interface at one pipe diameter upstream and three pipe diameters downstream of the artificial heart valve ring plane. The pressure sensor is arranged at this position to facilitate measurement of a more realistic and stable pressure difference before and after the valve.

[0025] 4. The present invention realizes flexible control of the pressure value by adjusting the rotation speed of the driving device (magnetic pump), which is conducive to the flexible selection of the pressure value for adults and minors under different blood pressure conditions.

[0026] 5. The present invention realizes precise and automatic measurement of leakage through a high-precision flow meter, which is accurate and convenient.

[0027] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0029] Figure 1 The present invention is a schematic structural diagram of a device for testing steady-state leakage and forward flow of a heart valve.

[0030] Figure 2 Schematic diagram of a steady-state leakage test of a heart valve.

[0031] Figure 3 This is a schematic diagram of the structure from another perspective during the steady-state leakage test of the heart valve.

[0032] Figure 4 Schematic diagram of the steady-state forward flow test of the heart valve.

[0033] Figure 5 This is a schematic diagram of the structure from another perspective during the steady-state forward flow test of the heart valve.

[0034] Figure 6 Schematic diagram of the structure of the aortic valve inflow end clamp.

[0035] Figure 7 Schematic diagram of the structure of the aortic valve outflow clamp.

[0036] Figure 8 Schematic diagram of an axial cross section of the aortic valve fixation ring.

[0037] Fig. 9 It is a schematic diagram of the structure of the inflow end clamp of the mitral valve.

[0038] Fig.10 It is a schematic diagram of the structure of the mitral valve outflow end clamp.

[0039] Fig.11 It is a schematic diagram of an axial cross section of a mitral valve fixing ring.

[0040] In the accompanying drawings, the components represented by the reference numerals are listed as follows: 1-water reservoir, 2-driving device, 3-regulating valve, 4-front end flow meter, 5-front end valve installation channel, 6-rear end valve installation channel, 7-rear end flow meter, 8-three-way ball valve, 9-pressure gauge, 10-liquid storage barrel, 11-differential pressure gauge, 12-aortic valve fixing ring, 13-aortic valve inflow end clamp, 14-aortic valve outflow end clamp, 15-mitral valve fixing ring, 16-mitral valve inflow end clamp, 17-mitral valve outflow end clamp, 18-heating device, 19-differential pressure sensor interface A, 20-differential pressure sensor interface B, 21-quick buckle, 22-pipeline, 23-branch pipeline, 24-first frame, 25-second frame, 26-first carrier plate, 27-second carrier plate. DETAILED DESCRIPTION

[0041] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Specific embodiment one: See also Figure 1-11 As shown, the present invention is a heart valve steady-state leakage and forward flow test device, comprising a water reservoir 1, a pipeline 22, and a driving device 2, a regulating valve 3, a front-end flow meter 4, a front-end valve installation channel 5, and a rear-end valve installation channel 6 which are sequentially installed on the pipeline 22. Both ends of the pipeline 22 are connected to the water reservoir 1.

[0043] A three-way ball valve 8 is installed on the pipeline 22 between the rear valve installation channel 6 and the water reservoir 1. A branch pipeline 23 is installed at the third end of the three-way ball valve 8. A rear flow meter 7 is installed on the branch pipeline 23.

[0044] The front valve installation channel 5 is connected to a pressure gauge 9. A differential pressure sensor interface A19 is set at one inner diameter of the front valve installation channel 5 from the test piece tooling; a differential pressure sensor interface B20 is set at three inner diameters of the rear valve installation channel 6 from the test piece tooling. The differential pressure sensor interface A19 and the differential pressure sensor interface B20 are both Luer connectors. A differential pressure gauge 11 is connected and installed between the differential pressure sensor interface A19 and the differential pressure sensor interface B20.

[0045] The pressure gauge 9 can be calibrated by mechanical calibration method, using a standard mechanical pressure source for calibration. The flowmeter calibration of the front flowmeter 4 and the rear flowmeter 7 can be calibrated by dynamic volume method. During the fluid flow process, the volume of fluid flowing through the flowmeter in a certain period of time is measured and compared with the actual outflow volume. The purpose of calibration is to determine the accuracy of the test set pressure value and the leakage amount obtained by the flow rate.

[0046] The front valve installation channel 5 and the rear valve installation channel 6 are connected by a quick buckle 21. A test piece tooling for clamping and installing the aortic valve / mitral valve is clamped and installed between the front valve installation channel 5 and the rear valve installation channel 6.

[0047] Among them, the test piece fixture for clamping and installing the aortic valve includes an aortic valve fixing ring 12, an aortic valve inflow end clamp 13 and an aortic valve outflow end clamp 14 for use. The aortic valve fixing ring 12, the aortic valve inflow end clamp 13 and the aortic valve outflow end clamp 14 are all annular structures. The aortic valve is fixedly installed on the inner ring surface of the aortic valve fixing ring 12. The aortic valve fixing ring 12 and the aortic valve inflow end clamp 13 are provided with a first step surface that cooperates with each other. The aortic valve outflow end clamp 14 is provided with a second step surface that cooperates with the aortic valve fixing ring 12. The inner diameter of the straight tube of the front valve installation channel 5 and the inner diameter of the straight tube of the rear end valve installation channel 6 are both 35mm.

[0048] Among them, the test piece fixture for clamping and installing the mitral valve includes a mitral valve fixing ring 15, a mitral valve inflow end clamp 16 and a mitral valve outflow end clamp 17 for use with each other. The mitral valve fixing ring 15, the mitral valve inflow end clamp 16 and the mitral valve outflow end clamp 17 are all annular structures. The mitral valve is fixedly installed on the inner ring surface of the mitral valve fixing ring 15. The mitral valve fixing ring 15 and the mitral valve outflow end clamp 17 are provided with a third step surface that cooperates with each other. The mitral valve inflow end clamp 16 is provided with a fourth step surface that cooperates with the mitral valve fixing ring 15. The inner diameter of the straight tube of the front valve installation channel 5 and the inner diameter of the straight tube of the rear valve installation channel 6 are both 70mm.

[0049] In order to seal the test piece fixture with the front valve installation channel 5 and the rear valve installation channel 6, a gasket A is provided between the test piece fixture and the butt end of the front valve installation channel 5. A gasket B is provided between the test piece fixture and the butt end of the rear valve installation channel 6.

[0050] The water reservoir 1 is equipped with a heating device 18. The heating device 18 includes an electric heating rod, a temperature controller and a temperature sensor. The electric heating rod is installed through the side wall of the water reservoir 1, the temperature sensor is inserted into the water of the water reservoir 1, and the temperature controller is glued and fixed on the outer wall of the water reservoir 1.

[0051] The driving device 2 is a magnetic pump, which controls the output flow and pressure of the pump by adjusting the motor speed. The higher the speed, the greater the flow and pressure.

[0052] The first frame 24 and the second frame 25 are also included. The water reservoir 1 is installed on the middle frame of the first frame 24. The first carrier plate 26 and the second carrier plate 27 are linearly slidably installed on the bottom frame of the second frame 25. The front valve installation channel 5 is installed and fixed on the first carrier plate 26. The rear valve installation channel 6 is installed and fixed on the second carrier plate 27.

[0053] When the steady-state leakage test device of the heart valve is performed, a liquid storage barrel 10 is also used, and the liquid storage barrel 10 is placed below the end of the branch pipeline 23 .

[0054] A compliance chamber is installed on the pipeline between the driving device 2 and the regulating valve 3 to stabilize the pressure and flow rate, and the oscillation amplitude of the pressure and flow rate is reduced by adjusting the air volume in the compliance chamber.

[0055] Heart valve steady-state leakage test device test process (1) How to use the aortic valve steady-state leakage test device: Adjust the temperature: the water in the water reservoir 1 is stabilized at 37°C ± 2°C under the temperature control of the heating device 18.

[0056] Calibration: Use the front valve installation channel 5 and the rear valve installation channel 6 with an inner diameter of 35 mm to perform pressure calibration and flow meter calibration. Install the two sensor connectors of the differential pressure gauge 11 to the differential pressure sensor interface A19 and the differential pressure sensor interface B20 respectively.

[0057] Install the test piece: install the test piece aortic valve into the aortic valve fixing ring 12, and install the gasket A, the aortic valve outflow end clamp 14, the aortic valve fixing ring 12, the aortic valve inflow end clamp 13, and the gasket B in sequence between the front valve installation channel 5 and the rear valve installation channel 6, and use the quick buckle 21 to connect and clamp.

[0058] Measuring steady-state leakage: Start the drive device 2, adjust the regulating valve 3 to the flow state, and adjust the three-way ball valve 8 to the state where the pipeline 22 on the side of the rear valve installation channel 6 is connected to the branch pipeline 23. The water in the reservoir 1 passes through the aortic valve at the stable output pressure set by the drive device 2 to realize the circulation of the entire system. When the differential pressure gauge 11 stabilizes at the specified pressure difference requirement, the value displayed by the rear flow meter 7 is the steady-state leakage.

[0059] (2) Method of using the mitral valve steady-state leakage test device: Adjust the temperature: the water in the water reservoir 1 is stabilized at 37°C ± 2°C under the temperature control of the heating device 18.

[0060] Calibration: Use the front valve installation channel 5 and the rear valve installation channel 6 with an inner diameter of 70 mm to perform pressure calibration and flow meter calibration. Install the two sensor connectors of the differential pressure gauge 11 to the differential pressure sensor interface A19 and the differential pressure sensor interface B20 respectively.

[0061] Install the test piece: install the test piece mitral valve into the mitral valve fixing ring 15, and install the gasket A, the mitral valve outflow end clamp 17, the mitral valve fixing ring 15, the mitral valve inflow end clamp 16, and the gasket B in sequence between the front end valve installation channel 5 and the rear end valve installation channel 6, and use the quick buckle 21 to connect and clamp.

[0062] Measuring steady-state leakage: Start the drive device 2 and adjust the regulating valve 3 to the flow state. The water in the reservoir 1 passes through the mitral valve at the stable output pressure set by the drive device 2 to realize the circulation of the entire system. When the differential pressure gauge 11 stabilizes at the specified pressure difference requirement, the value displayed by the rear-end flow meter 7 is the steady-state leakage.

[0063] Heart valve steady-state forward flow test process (1) How to use the aortic valve steady-state forward flow test device: Adjust the temperature: the water in the water reservoir 1 is stabilized at 37°C ± 2°C under the temperature control of the heating device 18.

[0064] Calibration: Use the front valve installation channel 5 and the rear valve installation channel 6 with an inner diameter of 35 mm to perform pressure calibration and flow meter calibration. Install the two sensor connectors of the differential pressure gauge 11 to the differential pressure sensor interface A19 and the differential pressure sensor interface B20 respectively.

[0065] Install the test piece: install the test piece aortic valve into the aortic valve fixing ring 12, and install the gasket A, the aortic valve inflow end clamp 13, the aortic valve fixing ring 12, the aortic valve outflow end clamp 14, and the gasket B in sequence between the front valve installation channel 5 and the rear valve installation channel 6, and use the quick buckle 21 to connect and clamp.

[0066] Measuring steady-state forward flow: Start the drive device 2, adjust the regulating valve 3 to the flow state, and adjust the three-way ball valve 8 to the state where the side pipeline 22 of the rear valve installation channel 6 and the branch pipeline 23 are not connected. The water in the reservoir 1 passes through the aortic valve at the stable output pressure set by the drive device 2 to realize the circulation of the entire system. When the differential pressure meter 11 stabilizes at the specified pressure difference requirement, the value displayed by the front flow meter 4 is the steady-state forward flow.

[0067] (2) How to use the mitral valve steady-state forward flow test device: Adjust the temperature: the water in the water reservoir 1 is stabilized at 37°C ± 2°C under the temperature control of the heating device 18.

[0068] Calibration: Use the front valve installation channel 5 and the rear valve installation channel 6 with an inner diameter of 35 mm to perform pressure calibration and flow meter calibration. Install the two sensor connectors of the differential pressure gauge 11 to the differential pressure sensor interface A19 and the differential pressure sensor interface B20 respectively.

[0069] Install the test piece: install the test piece mitral valve into the mitral valve fixing ring 15, and install the gasket A, the mitral valve inflow end clamp 16, the mitral valve fixing ring 15, the mitral valve outflow end clamp 17, and the gasket B in sequence between the front valve installation channel 5 and the rear valve installation channel 6, and use the quick buckle 21 to connect and clamp.

[0070] Measuring steady-state forward flow: Start the drive device 2, adjust the regulating valve 3 to the flow state, and adjust the three-way ball valve 8 to the state where the side pipeline 22 of the rear valve installation channel 6 and the branch pipeline 23 are not connected. The water in the reservoir 1 passes through the mitral valve at the stable output pressure set by the drive device 2 to realize the circulation of the entire system. When the differential pressure meter 11 stabilizes at the specified pressure difference requirement, the value displayed by the front flow meter 4 is the steady-state forward flow.

[0071] In the description of this specification, the description with reference to the terms "one embodiment", "example", "specific example", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0072] The preferred embodiments of the present invention disclosed above are only used to help illustrate the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to the specific implementation methods described. Obviously, many modifications and changes can be made according to the content of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can understand and use the present invention well. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A heart valve steady-state leakage and forward flow test device, characterized in that: It comprises a water reservoir (1), a pipeline (22), and a driving device (2), a regulating valve (3), a front-end flow meter (4), a front-end valve installation channel (5), and a rear-end valve installation channel (6) which are sequentially installed on the pipeline (22); both ends of the pipeline (22) are connected to the water reservoir (1); A three-way ball valve (8) is installed on the pipeline (22) between the rear-end valve installation channel (6) and the water reservoir (1); a branch pipeline (23) is installed on the third end of the three-way ball valve (8); and a rear-end flow meter (7) is installed on the branch pipeline (23); The front valve installation channel (5) and the rear valve installation channel (6) are connected via a quick buckle (21); a test piece tooling for clamping and installing an aortic valve / mitral valve is clamped and installed between the front valve installation channel (5) and the rear valve installation channel (6); A pressure gauge (9) is connected and installed on the front valve installation channel (5); a differential pressure sensor interface A (19) is provided on the front valve installation channel (5) at a distance of one times the inner diameter of the test piece tooling; a differential pressure sensor interface B (20) is provided on the rear valve installation channel (6) at a distance of three times the inner diameter of the test piece tooling; and a differential pressure gauge (11) is connected and installed between the differential pressure sensor interface A (19) and the differential pressure sensor interface B (20).

2. The heart valve steady-state leakage and forward flow testing device according to claim 1, characterized in that: The test piece fixture for clamping and installing the aortic valve comprises an aortic valve fixing ring (12), an aortic valve inflow end clamp (13) and an aortic valve outflow end clamp (14) for use together; the aortic valve fixing ring (12), the aortic valve inflow end clamp (13) and the aortic valve outflow end clamp (14) are all annular structures; the aortic valve is fixedly installed on the inner ring surface of the aortic valve fixing ring (12); the aortic valve fixing ring (12) and the aortic valve inflow end clamp (13) are provided with a first step surface that cooperates with each other; the aortic valve outflow end clamp (14) is provided with a second step surface that cooperates with the aortic valve fixing ring (12); the straight tube inner diameter of the front end valve installation channel (5) and the straight tube inner diameter of the rear end valve installation channel (6) are both 35 mm.

3. The heart valve steady-state leakage and forward flow testing device according to claim 1, characterized in that: The test piece fixture for clamping and installing the mitral valve comprises a mitral valve fixing ring (15), a mitral valve inflow end clamp (16) and a mitral valve outflow end clamp (17) for use together; the mitral valve fixing ring (15), the mitral valve inflow end clamp (16) and the mitral valve outflow end clamp (17) are all annular structures; the mitral valve is fixedly installed on the inner ring surface of the mitral valve fixing ring (15); the mitral valve fixing ring (15) and the mitral valve outflow end clamp (17) are provided with a third step surface that cooperates with each other; the mitral valve inflow end clamp (16) is provided with a fourth step surface that cooperates with the mitral valve fixing ring (15); the straight tube inner diameter of the front valve installation channel (5) and the straight tube inner diameter of the rear valve installation channel (6) are both 70 mm.

4. The heart valve steady-state leakage and forward flow testing device according to claim 2 or 3, characterized in that: A gasket A is provided between the butt joint end of the test piece fixture and the front valve installation channel (5); and a gasket B is provided between the butt joint end of the test piece fixture and the rear valve installation channel (6).

5. The heart valve steady-state leakage and forward flow testing device according to claim 4, characterized in that: The water reservoir (1) is equipped with a heating device (18); the heating device (18) comprises an electric heating rod, a temperature controller and a temperature sensor.

6. The heart valve steady-state leakage and forward flow testing device according to claim 4, characterized in that: The differential pressure sensor interface A (19) and the differential pressure sensor interface B (20) are both Luer connectors.

7. The heart valve steady-state leakage and forward flow testing device according to claim 1, characterized in that: The driving device (2) is a magnetic pump.

8. The heart valve steady-state leakage and forward flow testing device according to claim 1, characterized in that: It also comprises a first frame (24) and a second frame (25); the water reservoir (1) is mounted on the middle frame of the first frame (24); a first carrier plate (26) and a second carrier plate (27) are linearly slidably mounted on the bottom frame of the second frame (25); the front valve mounting channel (5) is mounted and fixed on the first carrier plate (26); and the rear valve mounting channel (6) is mounted and fixed on the second carrier plate (27).

9. The heart valve steady-state leakage and forward flow testing device according to claim 4, characterized in that: A compliance chamber is installed on the pipeline between the driving device (2) and the regulating valve (3) for stabilizing pressure and flow.

10. The heart valve steady-state leakage and forward flow testing device according to claim 4, characterized in that: It also includes a liquid storage barrel (10), wherein the liquid storage barrel (10) is placed below the end of the branch pipeline (23).

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