A heart valve steady-state leakage test device and its use method

Abstract

The present invention discloses a heart valve steady-state leakage test device and a method of using the same, which belongs to the field of medical device inspection technology. The test device includes a water storage barrel and a water storage barrel, which are connected by a pipeline, and a test piece fixture for installing an artificial heart valve is arranged on the pipeline, so that the artificial heart valve is connected to the pipeline; a front-end pressure sensor is installed on the front side of the test piece fixture, and a rear-end pressure sensor is installed on the rear side of the test piece fixture. The water storage barrel is connected to an air source, and the water storage barrel is provided with a weighing device for weighing the change in the mass of the liquid inside it. Its working method includes calibration, installation of the test piece, and measurement of the static leakage. The technical solution exemplified in the present invention is used for conducting a steady-state leakage test of an artificial heart valve, which is easy to operate, meets the standard requirements, and the results are accurate and reliable.

Description

Technical Field

[0001] The invention relates to the technical field of medical device inspection, in particular to a heart valve steady-state leakage test device and a use method thereof. Background Art

[0002] An artificial heart valve is a cardiac implantable medical device for treating heart valve disease or defects. It has become a very important medical device in the field of cardiovascular treatment. Artificial heart valves are high-risk medical devices that are subject to national key supervision. Once problems occur with this type of device, it will pose great risks and hidden dangers to the user's life safety and must be identified and controlled in pre-market quality inspections.

[0003] In the quality inspection of artificial heart valves, the steady-state leakage test is a very important test item. In the industry standard GB12279-2008 "Cardiovascular Implant Artificial Heart Valves", the test method of the steady-state leakage test is normatively outlined, but the corresponding test device is not given.

[0004] At present, when conducting a steady-state leakage test, the artificial heart valve is generally installed on the fixture, liquid is supplied through a water pump, and finally the test data is obtained by manual weighing. However, this method still has the following obvious shortcomings:

[0005] 1. The relevant sensors of the assembled equipment are inconsistent with the standard requirements, affecting the accuracy of the test results;

[0006] 2. Direct pressurization through a water pump has poor stability;

[0007] 3. The test data is obtained by manual weighing, which results in large errors and low accuracy of the results.

[0008] The performance, quality and safety of artificial heart valves are also directly related to the quality of clinical treatment and the life safety of patients. Therefore, designing accurate and reliable test equipment to conduct quality inspection and evaluation of artificial heart valves will have great practical application value and significance.

[0009] Based on the above practical needs, designing a heart valve steady-state leakage test device that is easy to operate and has high test result accuracy is a problem that needs to be solved at present. Summary of the invention

[0010] In order to solve the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide a heart valve steady-state leakage test device and a method of using the same. The test device is used to perform a steady-state leakage test on an artificial heart valve, meets standard requirements, and produces accurate and reliable results.

[0011] The technical solution adopted by the present invention to solve the technical problem is:

[0012] On the one hand, the present invention provides a heart valve steady-state leakage test device, comprising a water storage barrel and a water storage barrel, the water storage barrel and the water storage barrel are connected by a pipeline, and a test piece fixture for installing an artificial heart valve is provided on the pipeline so that the artificial heart valve is connected to the pipeline; a front-end pressure sensor is installed on the front side of the test piece fixture, and a rear-end pressure sensor is installed on the rear side of the test piece fixture, the water storage barrel is connected to an air source, and the water storage barrel is provided with a weighing device for weighing the change in the mass of the liquid inside it.

[0013] Furthermore, the test piece fixture includes an inner ring and an outer ring that are used together. The inner ring and the outer ring are both annular structures. The inner ring is sleeved on the inner side of the outer ring. One end of the side wall of the outer ring is provided with one or more notches. The outer ring and the inner ring are provided with stepped surfaces that cooperate with each other; the stepped surfaces of the inner ring and the outer ring jointly clamp the artificial heart valve.

[0014] Furthermore, the specimen tooling is installed on the pipeline through a clamp, and the clamp includes a clamp A and a clamp B used in conjunction with each other, the front-end pressure sensor is installed on clamp B to detect the pressure of liquid passing through the inside thereof, and the rear-end pressure sensor is installed on clamp A to detect the pressure of liquid passing through the inside thereof; a telescopic part is provided on the pipeline connected to clamp A and / or clamp B, and the degree of clamping of the clamp can be controlled by controlling the pressure, and clamp A and / or clamp B are connected to a driving device for driving them to move so as to realize the separation and docking of the specimen tooling and the pipeline.

[0015] Furthermore, a water receiving basin is provided below the test piece fixture, and the water receiving basin is connected to a waste water bucket.

[0016] Furthermore, it also includes a frame, the bottom of which is provided with a base plate, the water storage barrel, the water storage barrel and the waste water barrel are all arranged on the base plate, and the clamp A, the clamp B and the driving device are arranged on the frame above the base plate.

[0017] Furthermore, the air source of the water storage barrel includes a positive pressure air source and a negative pressure air source.

[0018] Furthermore, a two-way valve is provided on the pipeline between the water storage barrel and the test piece fixture, and a three-way valve is provided on the pipeline between the water storage barrel and the test piece fixture. The two-way valve is connected to the front-end pressure sensor and the rear-end pressure sensor and is controlled by pressure feedback.

[0019] Furthermore, the weighing device includes a tension pressure sensor and a weighing bucket, the top of the weighing bucket is hung on the tension pressure sensor, the bottom of the weighing bucket is located inside the water storage bucket, there is a gap between the weighing bucket and the side wall of the water storage bucket, and the pipeline is connected to the gap.

[0020] Furthermore, there is a gap between the weighing bucket and the bottom of the water storage bucket, the water storage bucket stores the test medium and the liquid level is higher than the bottom of the weighing bucket, and the part of the pipeline located inside the water storage bucket extends to the bottom of the water storage bucket.

[0021] On the other hand, the present invention also provides a method for using the above-mentioned heart valve steady-state leakage test device, comprising:

[0022] Calibration: perform pressure calibration and weighing system calibration. The pressure calibration is performed by a pressure gauge. The weighing system calibration is performed by adding the liquid in the water storage bucket to above the bottom of the weighing bucket. First, an initial force value F1 is measured. Then, a force value F2 is measured after a certain amount of water is added to the water storage bucket. The force value change per milliliter of water is calculated by (F2-F1) / added water volume (ml);

[0023] Install the test piece: assemble the test piece between the inner ring and the outer ring of the test piece fixture, and install the test piece fixture with the test piece between the fixture A and the fixture B. The fixture A and the fixture B are connected to clamp the test piece fixture with the test piece on the entire pipeline; start the air source of the water storage barrel, and the water in the water storage barrel passes through the artificial heart valve under the set pressure to reach the water storage barrel;

[0024] Measuring static leakage: The weighing device obtains the change in buoyancy of the weighing bucket, and obtains the amount of water leaking in the water storage bucket based on the change in force value per milliliter of water and the change in buoyancy of the weighing bucket; or the water in the water storage bucket is drawn out for weighing.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] 1. In the steady-state leakage test device for heart valves of the example of the present invention, the distances between the front-end pressure sensor and the rear-end pressure sensor and the test piece are fixed, so that the positions of the two sensors are standard positions, and the detection data is more accurate; an air source is arranged in the water storage barrel, and water is pressed out by pressurizing the air source, and the pressure is stable, so that the front and rear sides of the test piece maintain a stable pressure difference, and will not produce continuous impact like a pulse pump, which meets the steady-state requirements of the steady-state leakage test, and the reference value of the test results is higher; a weighing device is arranged to complete the weighing of the leaking liquid, which improves the accuracy of the results compared with manual weighing, reduces labor, and improves work efficiency; it greatly reduces the error of current tests, and can accurately and reliably detect and evaluate the quality of artificial heart valves, which has great practical application value and significance.

[0027] 2. In the heart valve steady-state leakage test device of the example of the present invention, the test piece tooling is composed of an inner ring and an outer ring. A notch is provided on the outer ring to facilitate the grasping of the inner ring and thus facilitate the installation and removal of the inner ring. The artificial heart valve is clamped by the cooperation of the inner ring and the outer ring. The stepped surfaces of the inner ring and the outer ring cooperate to ensure that the test medium will not leak from the edge of the test piece, which is conducive to the smooth progress of the test.

[0028] 3. In the heart valve steady-state leakage test device of the example of the present invention, the test piece tooling is installed on the pipeline through a clamp, and the clamp can be moved under the drive of a driving device, which is convenient for the assembly and disassembly of the test piece tooling, and the operation is more convenient. In addition, the influence on the data during the assembly process can be reduced by controlling the clamping force.

[0029] 4. In the heart valve steady-state leakage test device of the example of the present invention, a water collecting basin is arranged below the test piece tooling, and the water collecting basin is connected to the waste water bucket to collect and clean the test medium flowing out during the calibration process. It is easy to use and will not pollute the laboratory environment.

[0030] 5. The components of the heart valve steady-state leakage test device of the example of the present invention are integrated and supported by a frame. The frame has an upper and lower layered structure, which makes the structure of the entire device more compact and occupies a small area. The reasonable arrangement of the upper and lower layers is conducive to the smooth transportation of the test medium, thereby facilitating the smooth progress of the test.

[0031] 6. In the heart valve steady-state leakage test device of the example of the present invention, the air source of the water storage barrel includes a positive pressure air source and a negative pressure air source. The positive pressure air source can press the test medium from the water storage barrel to the water storage barrel, and the negative pressure air source can suck the test medium back, thereby realizing the reuse of the test medium and saving the test medium.

[0032] 7. In the heart valve steady-state leakage test device of the example of the present invention, the weighing device includes a tension and pressure sensor and a weighing bucket. The leakage of the test piece is obtained by measuring the buoyancy of the test medium entering the water storage bucket on the weighing bucket, thereby avoiding the phenomenon of inaccurate data caused by liquid shaking when directly measuring the mass change of the water storage bucket; the part of the pipeline located inside the water storage bucket extends to the bottom of the water storage bucket, so that the increase of liquid in the water storage bucket is very stable, and the shaking amplitude is very small, and the shaking amplitude can be controlled within the accuracy allowable range of ±1ml. A plurality of water outlets can also be arranged on the pipeline in the water storage bucket to avoid disturbance of the entire flow field. In actual operation, the leakage is small and the water wave disturbance is extremely small, thereby ensuring the accuracy of the test data.

[0033] 8. In the heart valve steady-state leakage test device of the example of the present invention, there is a gap between the weighing bucket and the bottom of the water storage bucket. The water storage bucket stores the test medium and the liquid level is higher than the bottom of the weighing bucket, which ensures that the weighing bucket will not be affected by the supporting force of the bottom of the water storage bucket. The weighing device adopts a tension pressure sensor. The weighing bucket itself has a certain weight. If the buoyancy is greater than the mass of the weighing bucket, the force value can still be measured. The leakage amount is mainly calculated by the mass difference. When the buoyancy generated by each milliliter of water is known, the leakage amount can be calculated by calculating the change in buoyancy, and the data accuracy is high.

[0034] 9. The method of using the test device of the example of the present invention reduces manual labor, is easy to operate and reduces test errors; the pressure of the water storage barrel is stable, which better simulates the actual usage situation. The leakage amount is measured by measuring the buoyancy of the weighing barrel, avoiding the phenomenon of inaccurate data caused by liquid surface shaking. The obtained test results are more accurate and have a higher reference value. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Other features, objects and advantages of the present application will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0036] Figure 1 It is a schematic diagram of the main structure of a heart valve steady-state leakage test device according to an embodiment of the present invention;

[0037] Figure 2 It is a schematic diagram of the top view of the structure of the heart valve steady-state leakage test device according to an embodiment of the present invention;

[0038] Figure 3 It is a side view structural schematic diagram of a heart valve steady-state leakage test device according to an embodiment of the present invention;

[0039] Figure 4 It is a schematic diagram of the structure of the outer ring of the test piece tooling in an embodiment of the present invention;

[0040] Figure 5 for Figure 4 AA section view;

[0041] Figure 6 for Figure 4 BB cross-sectional view;

[0042] Figure 7 It is a schematic diagram of the structure of the inner ring of the test piece tooling in an embodiment of the present invention;

[0043] Figure 8 for Figure 7 CC section view;

[0044] Fig. 9 for Figure 7 Bottom view of

[0045] Fig.10 It is a schematic diagram of the three-dimensional structure of the test piece tooling according to an embodiment of the present invention;

[0046] Fig.11 It is a three-dimensional structural schematic diagram of a test piece tooling and a fixture according to an embodiment of the present invention;

[0047] Fig.12 This is a schematic diagram of the structure of a water storage bucket and a weighing device according to an embodiment of the present invention;

[0048] Fig.13This is a wiring diagram in a control box according to an embodiment of the present invention;

[0049] Fig.14 A schematic diagram of the control principle of an embodiment of the present invention;

[0050] Fig.15 Schematic diagram of the circuit structure of an embodiment of the present invention.

[0051] In the figure: 1 water storage bucket, 2 weighing bucket, 3 pipeline, 4 tension pressure sensor, 5 three-way valve, 6 rear end pressure sensor, 7 fixture A, 8 test piece fixture, 81 outer ring, 811 notch, 82 inner ring, 9 fixture B, 10 front end pressure sensor, 11 driving device, 12 two-way valve, 13 water basin, 14 water storage bucket, 15 control box, 16 waste water bucket, 17 test medium, 18 water tank. DETAILED DESCRIPTION

[0052] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments.

[0053] The components of the embodiments of the present invention generally described and shown in the drawings herein may be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention.

[0054] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative work shall fall within the scope of protection of the present invention.

[0055] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0056] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0057] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. It should also be noted that, for ease of description, only the parts related to the invention are shown in the drawings.

[0058] like Figure 1-Figure 3 As shown, this embodiment provides a heart valve steady-state leakage test device, including a water storage barrel 14 and a water storage barrel 1, the water storage barrel 14 and the water storage barrel 1 are connected via a pipeline 3, and a test piece fixture 8 for installing an artificial heart valve is provided on the pipeline 3, so that the artificial heart valve is connected to the pipeline 3; a front-end pressure sensor 10 is installed on the front side of the test piece fixture 8, and a rear-end pressure sensor 6 is installed on the rear side of the test piece fixture 8, the water storage barrel 14 is connected to an air source, and the water storage barrel 1 is provided with a weighing device for weighing the change in the mass of the liquid inside it.

[0059] like Figure 4-Figure 10 As shown, the test piece fixture includes an inner ring 82 and an outer ring 81 used together. The inner ring 82 and the outer ring 81 are both annular structures. The inner ring 82 is sleeved on the inner side of the outer ring 81. One end of the side wall of the outer ring 81 is provided with one or more notches 811. The outer ring 81 and the inner ring 82 are provided with mutually matching stepped surfaces. The stepped surfaces of the inner ring 82 and the outer ring 81 clamp the artificial heart valve together. In this embodiment, two arc-shaped notches 811 are symmetrically provided on the outer ring 81. The outer ring 81 and the inner ring 82 are made of plastic material, specifically nylon 6 or nylon 66.

[0060] like Fig.11 As shown, the test piece tooling is installed on the pipeline through a clamp, and the clamp includes a clamp A7 and a clamp B9 used in conjunction with each other. The front-end pressure sensor 10 is installed on the clamp B9 to detect the pressure of the liquid passing through the inside thereof, and the rear-end pressure sensor 6 is installed on the clamp A7 to detect the pressure of the liquid passing through the inside thereof; a telescopic part is provided on the pipeline connected to the clamp A7 and / or the clamp B8, and the degree of clamping of the clamp can be controlled by controlling the pressure, and the clamp A7 and / or the clamp B9 is connected to a driving device 11 for driving it to move so as to realize the separation and docking of the test piece tooling and the pipeline 3.

[0061] Specifically, in this embodiment, a driving device 11 is provided on the clamp B9. The driving device 11 is a pneumatic element, such as a cylinder. The piston rod of the cylinder is connected to the clamp B9 to drive it to move. The clamping distance of the clamp can be controlled by the length of the piston rod, and the clamping degree can be controlled by the pressure of the air source to the piston. The telescopic part is composed of a bellows, and both the front-end pressure sensor 10 and the rear-end pressure sensor 6 can adopt imported high-precision diffused silicon pressure transmitters, model: PTL516.

[0062] A water receiving basin 13 is provided below the test piece fixture 8 , and the water receiving basin 13 is connected to a waste water bucket 16 , so as to recover and clean the test medium flowing down from the test piece fixture 8 during the calibration process.

[0063] The test device of this embodiment also includes a frame, a bottom plate is provided at the bottom of the frame, the water storage barrel 14, the water storage barrel 1 and the waste water barrel 16 are all arranged on the bottom plate, and the clamp A7, the clamp B9 and the driving device 11 are arranged on the frame above the bottom plate and located in the middle layer of the frame, arranged in high and low order, which saves more space and facilitates the transportation of the test medium.

[0064] The air source of the water storage barrel 14 includes a positive pressure air source and a negative pressure air source. The positive pressure air source can press the test medium from the water storage barrel 14 to the water storage barrel 1, and the negative pressure air source can suck the test medium back. The positive pressure air source can be connected to the cylinder of the driving device 11 at the same time to provide power for it.

[0065] A two-way valve 12 is provided on the pipeline 3 between the water storage bucket 14 and the test piece fixture 8, and a three-way valve 5 is provided on the pipeline 3 between the water storage bucket 1 and the test piece fixture 8. The two-way valve 12 is connected to the front-end pressure sensor 10 and the rear-end pressure sensor 6 and is controlled by pressure feedback. The two-way valve 12 is a switch for controlling the pipeline 3, and a solenoid valve can be used. During use, the pressure difference between the front-end pressure sensor 10 and the rear-end pressure sensor 6 is set on the control panel of the device, and the corresponding pressure sensor detects and calculates the pressure difference to form pressure feedback to control the switch of the solenoid valve to achieve the expected pressure difference. The three-way valve 5 is provided, and when measuring the leakage amount, the leaked liquid can be selected to be introduced into the water storage bucket 1 for automatic weighing through the three-way valve 5, or the leaked liquid can be selected to be introduced into the external outlet for manual connection of the leaked liquid and weighing with a balance, which is more flexible to use. The three-way valve 5 can also be selected as a solenoid valve.

[0066] like Fig.12As shown, the weighing device includes a tension and pressure sensor 4 and a weighing bucket 2. The top of the weighing bucket 2 is hung on the tension and pressure sensor 4. The bottom of the weighing bucket 2 is located inside the water storage bucket 1. There is a gap between the weighing bucket 2 and the side wall of the water storage bucket 1. The pipeline 3 is connected to the gap. The water storage bucket 1 can be set to a circle, and the weighing bucket 2 can be set to a rectangle. The diagonal length of the weighing bucket 2 is equal to the length of the inner diameter of the water storage bucket 1. The weighing bucket 2 is more stable under the constraint of the side wall of the water storage bucket 1. Specifically, the tension and pressure sensor 4 can be a miniature tension and pressure sensor, equipped with a GLY-Z high-precision weighing measurement module, model: LLLBM.

[0067] There is a gap between the weighing bucket 2 and the bottom of the water storage bucket 1. The water storage bucket 1 stores a test medium 17 and the liquid level of the test medium 17 is higher than the bottom of the weighing bucket 2. The weighing bucket 2 has a certain mass. The weighing device uses a tension pressure sensor 4. The weighing bucket 2 itself has a certain weight. If the buoyancy is greater than the mass of the weighing bucket 2, the force value can still be measured. The leakage is mainly calculated by the mass difference. When calibrating before the test begins, an initial force value F1 will be measured. After adding 2L of water, a force value F2 will be measured. (F2-F1) / 2000ml is the buoyancy generated by each milliliter of water. If the buoyancy generated by each milliliter of water is known, the leakage can be calculated by calculating the change in buoyancy. The part of the pipeline 3 located inside the water storage bucket 1 extends to the bottom of the water storage bucket 1, so that the increase of liquid in the water storage bucket 1 is very stable and will not cause shaking, ensuring the accuracy of the measurement data.

[0068] The weighing bucket 2 can adopt a barrel-shaped structure or a columnar structure. In other embodiments, if the diameter difference between the weighing bucket 2 and the water storage bucket 1 increases and there is space around the weighing bucket 2, a water distributor surrounding the weighing bucket 2 can also be set at the end of the pipeline 3 in the water storage bucket 1. A plurality of water outlet holes are evenly distributed on the water distributor so that the increase of liquid in the water storage bucket 1 is very stable and the disturbance of the entire flow field is avoided. In actual operation, the leakage is small and the water wave disturbance is extremely small, thereby ensuring the accuracy of the weighing data.

[0069] The test device can also be equipped with a control box 15 and a corresponding operation panel, so that the control parts of the driving components such as the gas source and the driving device 11 are integrated in the control box 15, which is more convenient for operation. The controller of the control box 15 adopts a PLC controller. The wiring of the control box 15 is as follows Fig.13 As shown, Fig.13 In the process, the gas source pump corresponds to the positive pressure gas source, and the vacuum pump corresponds to the negative pressure gas source. The control principle is as follows: Fig.14As shown. The PLC controller is only one optional control form, and those skilled in the art can also design other controllers based on the above working principle. The operation panel adopts a touch screen type. It is very common in the prior art to configure a control panel for the device. It is a known technology that those skilled in the art are proficient in, and its specific setting method will not be repeated here.

[0070] On the other hand, this embodiment also provides a method for using the above-mentioned heart valve steady-state leakage test device, including:

[0071] Calibration: perform pressure calibration and weighing system calibration. The pressure calibration is performed by a pressure gauge. The weighing system calibration is performed by adding the liquid in the water storage bucket 1 to above the bottom of the weighing bucket 2. First, an initial force value F1 is measured. Then, after a certain amount of water is added to the water storage bucket 14, a force value F2 is measured. The force value change per milliliter of water is calculated by (F2-F1) / added water amount (ml).

[0072] Specifically, pressure calibration through the pressure gauge can be performed by manual calibration. When calibrating the weighing system, turn on the power of the device to let the device pass the self-test, store compressed air in the positive pressure air source, enter the calibration page of the device, display the initial force value F1 at 0, and then measure a force value F2 after adding 2L of water to the water storage bucket 14, calculate the force value change per milliliter of water by (F2-F1) / 2000ml, and the calibration is completed.

[0073] Install the test piece: assemble the test piece between the inner ring 82 and the outer ring 81 of the test piece fixture 8, and install the test piece fixture 8 with the test piece between the clamp A7 and the clamp B9. The clamp A7 and the clamp B9 are connected to clamp the test piece fixture 8 with the test piece on the entire pipeline 3; start the air source of the water storage barrel 14, and the water in the water storage barrel 14 passes through the artificial heart valve under the set pressure to reach the water storage barrel 1.

[0074] Measuring static leakage: the weighing device obtains the buoyancy change of the weighing bucket 2, and obtains the amount of water leaking in the water storage bucket 1 according to the force value change per milliliter of water and the buoyancy change of the weighing bucket 2; or the water in the water storage bucket 1 is drawn out for weighing.

[0075] like Fig.15 As shown, by setting a three-way valve 5, the leaked liquid can be introduced into the water storage barrel 1 for automatic weighing, or the leaked liquid can be introduced into an external water receiving tank 18 for manual collection of the leaked liquid and weighing with a balance.

[0076] This embodiment also realizes a reflux function by providing a negative pressure gas source: after the test is completed, the negative pressure pump is operated to suck the liquid in the water storage barrel 1 back into the water storage barrel 14, thereby realizing the reuse of the liquid and saving resources.

[0077] The above description is only a preferred embodiment of the present application and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present application is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the present application.

[0078] Except for the technical features described in the specification, the remaining technical features are known technologies to those skilled in the art. In order to highlight the innovative features of the present invention, the remaining technical features will not be described here in detail.

Claims

1. A heart valve steady-state leakage test device, characterized in that: The invention comprises a water storage barrel and a water storage barrel, wherein the water storage barrel and the water storage barrel are connected through a pipeline, and a test piece fixture for installing an artificial heart valve is arranged on the pipeline so that the artificial heart valve is connected to the pipeline; a front-end pressure sensor is installed on the front side of the test piece fixture, and a rear-end pressure sensor is installed on the rear side of the test piece fixture, the water storage barrel is connected to an air source, and the water storage barrel is provided with a weighing device for weighing the mass change of the liquid inside the water storage barrel; The test piece fixture comprises an inner ring and an outer ring used in conjunction with each other, the inner ring and the outer ring are both annular structures, the inner ring is sleeved on the inner side of the outer ring, one end of the side wall of the outer ring is provided with one or more notches, and the outer ring and the inner ring are provided with mutually matching stepped surfaces; the stepped surfaces of the inner ring and the outer ring together clamp the artificial heart valve; The test piece tooling is installed on the pipeline through a fixture, and the fixture includes a fixture A and a fixture B used in conjunction with each other. The front-end pressure sensor is installed on the fixture B to detect the pressure of the liquid passing through the fixture, and the rear-end pressure sensor is installed on the fixture A to detect the pressure of the liquid passing through the fixture. The pipeline connected to the fixture A and / or the fixture B is provided with a telescopic part, and the degree of clamping of the fixture can be controlled by controlling the pressure. The fixture A and / or the fixture B are connected to a driving device that drives them to move so as to achieve separation and docking of the test piece tooling and the pipeline. The weighing device includes a tension and pressure sensor and a weighing bucket, wherein the top of the weighing bucket is hung on the tension and pressure sensor, and the bottom of the weighing bucket is located inside the water storage bucket. There is a gap between the weighing bucket and the side wall of the water storage bucket, and the pipeline is connected to the gap; There is a gap between the weighing bucket and the bottom of the water storage bucket. The water storage bucket stores a test medium and the liquid level is higher than the bottom of the weighing bucket. The part of the pipeline located inside the water storage bucket extends to the bottom of the water storage bucket.

2. The heart valve steady-state leakage test device according to claim 1, characterized in that: A water receiving basin is arranged below the test piece fixture, and the water receiving basin is connected to a waste water bucket.

3. The heart valve steady-state leakage test device according to claim 2, characterized in that: It also includes a frame, a bottom plate is arranged at the bottom of the frame, the water storage barrel, the water storage barrel and the waste water barrel are all arranged on the bottom plate, and the clamp A, the clamp B and the driving device are arranged on the frame above the bottom plate.

4. The heart valve steady-state leakage test device according to claim 1, characterized in that: The air source of the water storage barrel includes a positive pressure air source and a negative pressure air source.

5. The heart valve steady-state leakage test device according to claim 1, characterized in that: A two-way valve is provided on the pipeline between the water storage bucket and the test piece fixture, and a three-way valve is provided on the pipeline between the water storage bucket and the test piece fixture. The two-way valve is connected to the front-end pressure sensor and the rear-end pressure sensor and is controlled by pressure feedback.

6. A method for using the heart valve steady-state leakage test device as claimed in claim 1, characterized in that: include: Calibration: perform pressure calibration and weighing system calibration. The pressure calibration is performed by a pressure gauge. The weighing system calibration is performed by adding the liquid in the water storage bucket to above the bottom of the weighing bucket. First, an initial force value F1 is measured. Then, after a certain amount of water is added to the water storage bucket, a force value F2 is measured. The force value change per milliliter of water is calculated by (F2-F1) / added water volume (ml); Install the test piece: Assemble the test piece between the inner ring and the outer ring of the test piece fixture, and install the test piece fixture with the test piece between fixture A and fixture B. Clamp A and fixture B are connected to clamp the test piece fixture with the test piece on the entire pipeline; The air source of the water storage barrel is started, and the water in the water storage barrel passes through the artificial heart valve under the set pressure and reaches the water storage barrel; Measuring static leakage: The weighing device obtains the change in buoyancy of the weighing bucket, and obtains the amount of water leaking in the water storage bucket based on the change in force value per milliliter of water and the change in buoyancy of the weighing bucket; or the water in the water storage bucket is drawn out for weighing.

Images