A prosthetic heart valve steady flow testing device and method

Abstract

A kind of artificial heart valve steady flow testing device and testing method.Improvements are made to the artificial heart valve steady flow testing system technology.The existing testing device is not stable in operation, and has unreliable performance, low precision, and is not easy to replace the measured valve, and is complex to operate and other technical problems.The device of the present application, energy storage medium tank is connected to the inlet of throttling branch and valve two, valve two is connected to the inlet of valve test circuit, the outlet of valve test circuit is connected to forward flow test circuit A and regurgitation test circuit B in parallel through valve, forward flow test circuit A and regurgitation test circuit B are connected to the outlet of throttling branch and medium storage tank.For forward and regurgitation characteristics, the test channel is set to two orders of magnitude channels that can be switched, reducing data error.No need to remove the pipeline to replace the measured valve.Parallel forward flow and regurgitation nozzle are used, without changing the nozzle, two kinds of tests can be realized on a set of testing equipment, effectively improving work efficiency and reducing testing cost.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical test equipment, and particularly relates to an improvement of a steady flow test system for a prosthetic heart valve. BACKGROUND

[0002] At present, prosthetic heart valve replacement is an important treatment for end-stage heart valve disease. However, there are still many technical bottlenecks in the design, materials and manufacturing process of the existing prosthetic heart valve, resulting in a certain gap between its functional performance and the natural valve. Importantly, after the prosthetic heart valve is implanted in the human body, its hemodynamic characteristics are difficult to detect directly. Hemodynamic characteristics are crucial to the normal operation of the prosthetic heart valve, which is related to whether the valve can effectively simulate the function of the normal heart valve and ensure the normal flow of blood in the heart. If the hemodynamic characteristics are abnormal, it may cause serious complications such as blood reflux and thrombosis. Therefore, it is of great clinical significance to establish a perfect in vitro test system to comprehensively and accurately evaluate the working performance of the prosthetic heart valve before clinical application.

[0003] According to the relevant technical regulations in the field, steady flow test is an indispensable core link in the performance evaluation system of prosthetic heart valve. Steady flow test is divided into forward flow test and regurgitation test. Forward flow test is to simulate the quasi-steady flow state of the peak ejection period of the ventricle, and test the forward flow resistance performance of the valve; such resistance performance directly affects the load size of the heart during ejection, and if the resistance is too large, the heart needs to overcome greater resistance to push blood through the valve, which will further increase the burden of the heart. Regurgitation test is to simulate the leakage state after the valve is completely closed, and measure the closing quality of the valve. Under normal circumstances, the heart valve should be able to effectively prevent blood from flowing backward after closing, and through the regurgitation test, the closing quality of the valve can be accurately measured. If the valve has leakage problem, it will cause blood to flow backward, affecting the normal blood circulation and function of the heart.

[0004] At present, most prosthetic heart valve steady flow test devices still use the traditional scheme, that is, the test conditions are achieved by adjusting the liquid level. The traditional test system has poor running stability, insufficient performance reliability, and relatively complicated operation process. In addition, during the test, different specifications of valves need to be replaced, and the switching of forward flow and regurgitation test needs to replace the nozzle, and the replacement steps are relatively complex, which seriously affects the test efficiency.

[0005] In addition, the patent document "CN220293713U, a heart valve steady flow test system" proposes a technical solution of a related test system in order to understand the characteristics of artificial heart valve in hemodynamics. The patent document claims that the test system can synchronously measure the pressure difference and regurgitation leakage of the ex vivo heart valve, as well as the pressure difference and leakage flow of the calibration standard nozzle; and the calibration standard nozzle plays a comparison role, that is, by obtaining the pressure difference of the standard nozzle to calculate the acceptable precision tolerance. The data measurement of the calibration standard nozzle can ensure that the test data of the pressure difference and regurgitation leakage of the ex vivo heart valve is reasonable and reliable, and provides close-to-real test data support for valve repair instrument design. But after reading the whole text, we think that the patent document has the following technical problems: first, in the technical solution, the valve replacement is very complex, the entire pipeline needs to be removed to take out the bracket clamping the valve; second, the nozzles for forward flow and regurgitation test are different, and the test switching also needs to replace the nozzle; replacing the nozzle also needs to remove the pipeline, which is relatively cumbersome, and the medium in the pipeline will be empty when the pipeline is removed; third, during forward flow and regurgitation test, the transvalvular pressure difference at both ends of the valve is large, and they are in different orders of magnitude, so it is difficult to obtain accurate pressure data according to the technical solution of the document.

[0006] Therefore, how to design a test system that can adapt to the detection of forward flow and regurgitation with two different orders of magnitude to improve the stability, reliability and precision of the test, and facilitate the replacement of the sample, has become a technical problem to be solved in the field. SUMMARY

[0007] The present application provides a kind of artificial heart valve steady flow test device and test method, solve the technical problems of unstable operation, unreliable performance, low precision, difficult to replace the valve to be measured and complex operation of existing test device.

[0008] The artificial heart valve steady flow test device of the present application comprises a control loop and a circulation loop, the control loop comprises a controller, and the circulation loop comprises a pump, an energy storage medium tank, a valve test loop, a forward flow test loop, a regurgitation test loop, a throttling branch and a medium storage tank.

[0009] The pump is connected to the energy storage medium tank, the energy storage medium tank is connected in parallel to the inlet of the throttling branch and valve two, the valve two is connected to the inlet of the valve test loop, the outlet of the valve test loop is connected in parallel to the forward flow test loop and the regurgitation test loop through valve three, and the forward flow test loop and the regurgitation test loop are further connected to the outlet of the throttling branch and the medium storage tank.

[0010] A flow stabilizer is further arranged in front of the valve two.

[0011] The forward flow test loop comprises a forward flow nozzle, a differential pressure sensor four, a valve four and a valve five, the valve five, the forward flow nozzle and the valve four are connected in sequence, the differential pressure sensor four is connected with the forward flow nozzle in parallel; the differential pressure sensor four is connected with the controller;

[0012] The regurgitation test loop comprises a regurgitation nozzle, a differential pressure sensor three, a valve six and a valve seven, the valve seven, the regurgitation nozzle and the valve six are connected in sequence, the differential pressure sensor three is connected with the regurgitation nozzle in parallel; the differential pressure sensor three is connected with the controller;

[0013] The aperture of the forward flow nozzle port of the forward flow nozzle is larger than the aperture of the regurgitation nozzle port of the regurgitation nozzle.

[0014] Further, the valve test loop comprises a valve test section, a solenoid valve one, a solenoid valve two, a differential pressure sensor two and a differential pressure sensor one, a valve clamp,

[0015] The solenoid valve one, the differential pressure sensor two and the solenoid valve two are connected in sequence, and then connected with the differential pressure sensor one and the valve test section in parallel;

[0016] The solenoid valve one, the solenoid valve two, the differential pressure sensor two and the differential pressure sensor one are connected with the controller respectively.

[0017] Further, the valve test section comprises a front section, a rear section and a valve clamp, the front section and the rear section are oppositely arranged, a clamping station adapted to the valve clamp is formed between the front section and the rear section, the valve clamp is clamped in the clamping station, the top surfaces of the front section and the rear section are respectively provided with exhaust valves, the opposite surfaces of the front section and the rear section are respectively provided with inflation sealing rings corresponding to the valve clamp, and the inflation sealing rings are connected with inflation pumps.

[0018] Still further, the valve clamp is a T-shaped clamp, the T-shaped clamp comprises a sheet-shaped body and a lifting ring, a hole for accommodating a measured valve is formed in the center of the sheet-shaped body, and a silica gel sleeve one is further arranged between the measured valve and the hole.

[0019] Still further, the valve clamp is a rotary disc clamp, the rotary disc clamp comprises a rotary disc body and a rotary disc support, the rotary disc body is provided with a central rotating shaft, the central rotating shaft is movably connected with the rotary disc support, and the rotary disc support is fixedly arranged on the top surface of the front section or the rear section; a plurality of accommodating holes on the same circumference are arranged on the rotary disc body, a silica gel sleeve two is sleeved on the outer circle of the measured valve, and the silica gel sleeve two is arranged in the accommodating hole.

[0020] An axially movable positioning pin is arranged on the rotary disc support, a plurality of positioning holes are uniformly distributed on the outer side of the central rotating shaft of the rotary disc body, and the positioning pin is used for locking the rotary disc body.

[0021] Further, the valve clamp is a buckle type clamp, which comprises a buckle one, an upper box cover, a lower box cover and a hinge, one side of the upper box cover and the lower box cover is respectively fixedly connected to the upper and lower hinge pieces of the hinge, the other side of the upper box cover and the lower box cover is fixedly connected with the buckle one, a semicircular hole for accommodating the measured valve is respectively arranged between the upper box cover and the lower box cover, a positioning groove is arranged on the semicircular hole, and an outer circle of the measured valve is sleeved with a positioning silica gel sleeve matched with the positioning groove.

[0022] Further, the valve clamp is an open-close type clamp, which comprises a gasket, a buckle two and a clamp box, the clamp box is a left-right open-close structure, a hole for accommodating the measured valve is arranged in the center of the clamp box, a silica gel sleeve three is sleeved between the measured valve and the hole, gasket holes with a diameter larger than the hole are arranged on both sides of the clamp box, and the gasket holes are provided with the gasket.

[0023] As the testing method of the artificial heart valve steady flow testing device of the artificial heart valve, the artificial heart valve is loaded into the valve clamp, the system is started, and then the following steps are performed:

[0024] 1), forward flow test,

[0025] 1.1), test preparation,

[0026] 1.1.1), the measured valve is installed in the valve clamp in the forward direction, the valve clamp is fixed in the valve test section, and the sealing position of the valve test section is sealed by stepping on the air pump,

[0027] 1.1.2), the circulating pipeline is filled with liquid, and all valves are opened,

[0028] 1.1.3), valve control,

[0029] valve six and valve seven are closed, the regurgitation test circuit is in an open circuit state, and preparation for the forward flow test is completed,

[0030] 1.2), start testing,

[0031] 1.2.1), parameter setting,

[0032] the specification of the measured valve is selected, and the test flow is selected in sequence, and the test flow selection parameters are: 5L / min, 10L / min, 15L / min, 20L / min, 25L / min and 30L / min;

[0033] 1.2.2), obtain the forward flow value,

[0034]

[0035] Q = Q 前 is the real-time flow of the forward flow measured valve, unit: m 3 / s,

[0036] C is the flow coefficient, the value range is: 0.9-0.99,

[0037] A 前 is the forward flow nozzle orifice area, unit: m 2 ,

[0038] is the forward flow nozzle pressure difference, unit: Pa, collected by pressure difference sensor four 904,

[0039] is the test liquid density, unit: kg / m 3 ,

[0040] 1.2.3), read the forward flow valve transvalvular pressure difference,

[0041] At the same time, read the transvalvular pressure difference value Δp 前 ,

[0042] 1.2.4), get the effective valve orifice area,

[0043]

[0044] EOA is the effective valve orifice area, unit: cm 2 ,

[0045] q vRMS is the root mean square of Q 前 during the positive pressure difference, unit: ml / s,

[0046] is the average value of Δp 前 during the positive pressure difference, unit: mmHg,

[0047] is the density of the test liquid, unit: g / cm 3 ;

[0048] 2), install the measured valve upside down,

[0049] 3), regurgitation test,

[0050] 3.1) install the measured valve upside down in the valve clamp, fix the valve clamp in the valve test section, seal the sealing position of the valve test section by stepping on the air pump, and then fill the circulating pipeline with liquid,

[0051] Valve control during regurgitation test: close valve four and valve five, open valve six and valve seven, ready for regurgitation test,

[0052] 3.2)Start the test,

[0053] 3.2.1)Parameter setting,

[0054] Select the size of the valve to be tested, and select the test transvalvular pressure difference in turn, the specific parameters are: 40mmHg, 80mmHg, 120mmHg, 160mmHg, 200mmHg;

[0055] 3.2.2)Read the reverse transvalvular pressure difference of the valve,

[0056] Read the transvalvular pressure difference of the valve during reverse installation through pressure difference sensor one Δp 返 ,

[0057] 3.2.3)Obtain regurgitation flow data: the pressure difference of flow through the regurgitation nozzle-flow calculation formula, the formula is as follows:

[0058]

[0059] In the formula: Q 返 is the regurgitation flow, the unit is m 3 / s,

[0060] A 返 is the area of the regurgitation nozzle orifice, the unit is m 2 ;

[0061] is the pressure difference before and after the regurgitation nozzle, the unit is Pa, which is collected by pressure difference sensor three:

[0062] is the test liquid density, the unit is kg / m 3 ,

[0063] 4)Complete the test of one valve to be tested.

[0064] The present application is directed to the forward flow and regurgitation characteristics, and the test channel is innovatively set as a switchable test channel adapting to two different orders of magnitude flow, different range differential pressure sensors are used for forward flow test and regurgitation test, and the error of test data is reduced. The parallel connection of the forward flow nozzle and the regurgitation nozzle can also complete the switching of the nozzle through the switch manual ball valve. The valve clamp also adopts various embodiments, and the clamping and sealing are performed through the inflation sealing ring, different specifications of the measured valve can be quickly replaced, and different test scenes are adapted. The control system can clearly observe the data curves of the transvalvular pressure difference and the system flow, the test data can be collected after the curve is stable, the flow and the transvalvular pressure difference of the measured valve collected in the data report are displayed, the effective orifice area is automatically calculated through the internal program, and the test report is output after the test is completed. The transvalvular pressure difference Δp 前 of the valve and the effective orifice area EOA calculated through calculation are observed in the report, the blood flow resistance and the passing capacity of the valve can be evaluated, whether the physiological needs of the human body can be met can be evaluated, reliable performance basis is provided for valve design optimization and clinical application, and the regurgitation flow Q 返 can be calculated, which is a "gold standard" parameter for evaluating the closing performance of the artificial heart valve, and the closing integrity and structural reliability of the valve are verified.

[0065] The present application does not need to disassemble the entire pipeline to replace the measured valve, but only needs to replace the measured valve in the valve clamp. Meanwhile, the present application adopts the parallel connection of the forward flow nozzle and the regurgitation nozzle, the nozzle does not need to be replaced when the test is switched, the forward flow and the regurgitation test can be realized on a set of test equipment, the test precision and the work efficiency are effectively improved, and the test cost is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0066] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0067] Figure 1 is a perspective view of the present application;

[0068] Figure 2 is a hydraulic control principle diagram of the present application;

[0069] Figure 3 is a schematic view of the present application during forward flow test;

[0070] Figure 4 is a hydraulic control principle diagram of the present application during forward flow test;

[0071] Figure 5is a schematic diagram of the reflux test of the present application;

[0072] Figure 6 is a schematic diagram of the hydraulic control principle of the reflux test of the present application;

[0073] Figure 7 is a schematic diagram of the structure of the reflux nozzle of the present application;

[0074] Figure 8 is a schematic diagram of the assembly structure of the forward flow nozzle test section of the present application;

[0075] Figure 9 is a schematic diagram of the structure of the forward flow nozzle of the present application;

[0076] Figure 10 is a control principle diagram of the present application;

[0077] Figure 11 is a control flow diagram of the present application;

[0078] Figure 12 is a perspective view of the valve test section of the present application;

[0079] Figure 13 is a perspective view of the first structure form of the valve clamp of the present application;

[0080] Figure 14 is a schematic diagram of the loading state of the first structure form of the valve clamp;

[0081] Figure 15 is a schematic diagram of the structure of the first structure form of the valve clamp;

[0082] Figure 16 is a perspective view of the second structure form of the valve clamp of the present application;

[0083] Figure 17 is a schematic diagram of the loading state of the second structure form of the valve clamp;

[0084] Figure 18 is a schematic diagram of the structure of the second structure form of the valve clamp;

[0085] Figure 19 is a perspective view of the third structure form of the valve clamp of the present application;

[0086] Figure 20 is a schematic diagram of the loading state of the third structure form of the valve clamp;

[0087] Figure 21 is a schematic diagram of the structure of the third structure form of the valve clamp;

[0088] Figure 22 is a perspective view of the fourth structure form of the valve clamp of the present application;

[0089] Figure 23 is a schematic diagram of the mounted state of a fourth structure form of the valve clamp;

[0090] Figure 24 is a schematic diagram of the structure of a fourth structure form of the valve clamp;

[0091] Figure 25 is a forward flow nozzle calibration curve diagram;

[0092] Figure 26 is a regurgitation nozzle calibration curve diagram.

[0093] Fig. 1 is a rack,

[0094] 2 is a medium storage box, 201 is valve one,

[0095] 3 is a pump,

[0096] 4 is an energy storage medium tank,

[0097] 5 is a three-way,

[0098] 6 is the main flow path, 601 is the flow stabilizer, 602 is valve two, and 603 is valve three,

[0099] 7 is a throttling branch, 701 is a throttle valve,

[0100] 8 is a valve test section, 800 is a valve to be tested, 801 is an inflation pump, 81 is a front section, 82 is a rear section, 83 is a clamping station, 84 is an inflation sealing ring, and 85 is an exhaust valve,

[0101] 9 is a differential pressure sensor, 901 is a differential pressure sensor one, 902 is a differential pressure sensor two, 9021 is a solenoid valve one, 9022 is a solenoid valve two, 903 is a differential pressure sensor three, and 904 is a differential pressure sensor four,

[0102] 10 is a controller,

[0103] 11 is a return line,

[0104] 12 is a valve clamp,

[0105] 121 is a T-shaped clamp, 1211 is a silicone sleeve one, and 1212 is a lifting ring,

[0106] 122 is a rotary disc clamp, 1221 is a silicone sleeve two, 1222 is a rotary disc support, 12221 is a positioning pin, 1223 is a central rotating shaft, 1224 is a containing hole, and 1225 is a positioning hole,

[0107] 123 is a buckle clamp, 1231 is a positioning silicone sleeve, 1232 is a buckle one, 1233 is an upper box cover, 1234 is a lower box cover, 1235 is a hinge, and 1236 is a positioning groove,

[0108] 124 is a clasp, 1241 is a silica gel sleeve three, 1242 is a gasket, 1243 is a buckle two, 1244 is a clasp box

[0109] A is a forward flow test loop, A0 is a forward flow nozzle, A01 is a forward flow nozzle port, A1 is a valve four, A2 is a valve five,

[0110] B is a reflux test loop, B0 is a reflux nozzle, B01 is a reflux nozzle port, B1 is a valve six, B2 is a valve seven. DETAILED DESCRIPTION

[0111] The technical solutions of the present application are further illustrated below in conjunction with the drawings and through specific embodiments.

[0112] Wherein, the drawings are only used for exemplary illustration, and the representations are only schematic diagrams, not physical diagrams, and cannot be understood as limitations on the present patent; in order to better illustrate the embodiments of the present application, some components of the drawings will be omitted, enlarged or reduced, and do not represent the size of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the drawings can be omitted.

[0113] The same or similar reference numerals in the drawings of the embodiments of the present application correspond to the same or similar components; in the description of the present application, it should be understood that if the terms "upper", "lower", "left", "right", "inner", "outer" and the like indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore the terms describing the positional relationship in the drawings are only used for exemplary illustration, and cannot be understood as limitations on the present patent, for those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0114] In the description of the present application, unless otherwise explicitly specified and limited, if the term "connection" and the like indicating the connection relationship between components appears, the term should be broadly understood, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two components or the interaction relationship between two components. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0115] The drawings attached to the specification Figures 1-26 The present application is further described below.

[0116] As Figures 1-2As shown, a kind of artificial heart valve steady flow test device, including control loop and circulation loop, control loop includes controller 10, circulation loop includes: pump 3, energy storage medium tank 4, valve test loop, forward flow test loop A, regurgitation test loop B, throttling branch 7 and medium storage tank 2;Pump 3 connects energy storage medium tank 4, energy storage medium tank 4 is connected in parallel with the inlet of throttling branch 7 and valve two 602, valve two 602 is connected with the inlet of valve test loop, the outlet of valve test loop is connected with forward flow test loop A and regurgitation test loop B in parallel by valve three 603, and forward flow test loop A and regurgitation test loop B are connected with the outlet of throttling branch 7 and medium storage tank 2 again.The whole machine architecture is on rack 1, and the working path is: the low outlet of medium storage tank 2 is connected with pump 3 by valve one 201, then is connected with energy storage medium tank 4 by pipeline, the rear end of energy storage medium tank 4 is connected with three-way 5, one end is connected with main flow path 6 (in turn has flow stabilizer 601, valve two 602, then is connected with valve test section 8), the other end is connected with throttling branch 7;The rear end of valve test section 8 is connected with valve three 603, then is connected with the aforementioned forward flow test loop A and regurgitation test loop B in parallel, and the outlet of forward flow test loop A and regurgitation test loop B is connected with backflow pipeline 11 and throttling branch 7;Throttle valve 701 is provided on throttling branch 7, and the system flow in forward flow test process can be conveniently adjusted.Control device, the container of differential pressure sensor 9 is provided in the lower part of rack 1, wherein a plurality of differential pressure sensors are provided, and each differential pressure sensor is connected with controller 10.The aperture of forward flow nozzle port A01 of forward flow nozzle A0 is greater than the aperture of regurgitation nozzle port B01 of regurgitation nozzle B0, and in the embodiment, the aperture of forward flow nozzle port A01 is φ15-27mm, and the aperture of regurgitation nozzle port B01 is φ2-8mm.

[0117] Further, the front of valve two 602 is also provided with flow stabilizer 601, which can eliminate fluid flow fluctuation, maintain stable output and improve the reliability of the system.

[0118] Further, the valve test loop includes valve test section 8, electromagnetic valve one 9021, electromagnetic valve two 9022, differential pressure sensor two 902 and differential pressure sensor one 901, valve clamp 12,

[0119] Electromagnetic valve one 9021, differential pressure sensor two 902 and electromagnetic valve two 9022 are connected in sequence, and are connected in parallel with differential pressure sensor one 901 and valve test section 8;

[0120] The electromagnetic valve one 9021, the electromagnetic valve two 9022, the differential pressure sensor two 902 and the differential pressure sensor one 901 are connected to the controller 10 respectively. The controller includes a PLC control system and an operation program; the rotation speed of the pump 3, the opening degree of the electric control ball valve and the opening and closing of the electromagnetic valve are accurately controlled through the PLC, so as to realize accurate regulation and control of the whole test process. At the same time, the system collects the measurement data of the high-precision differential pressure sensor in real time, forms a closed-loop feedback regulation mechanism, and ensures the stability and reliability of the test working condition. The operation interface integrates two function modules of forward flow test and backflow test. Before the test starts, the operator needs to select the test type and register the test related information, including the operator, the test date and the batch data. The operation interface will display the selected valve specification and the corresponding test parameter setting, and after confirming the parameters, the system will automatically adjust the key parameters such as flow and differential pressure to the set value, and judge the system stability by monitoring the data fluctuation in real time. After the data is stable, click the acquisition button to collect data, and click the save button after the test is completed to output the test report.

[0121] Further, the forward flow test loop A includes a forward flow nozzle A0, a differential pressure sensor four 904, a valve four A1 and a valve five A2, the valve five A2, the forward flow nozzle A0 and the valve four A1 are connected in sequence, and the differential pressure sensor four 904 is connected with the forward flow nozzle A0 in parallel; the differential pressure sensor four 904 is connected to the controller 10.

[0122] When the artificial heart valve is tested by forward flow, according to the test requirements given by the standard ISO5840-2021, the trans-valve pressure difference of the measured valve is measured under the condition that the flow range is 5L / min to 30L / min, and the effective valve orifice area is calculated. For example, the forward flow test loop A is used to test the valve, and the differential pressure sensor four 904 is connected to the controller 10. Figures 3-4As shown, the specific test is as follows: initially, all valves are closed. Turn on the control system, select the measured valve 800, load the measured valve 800 into the corresponding valve clamp 12 in the forward direction, and install the valve clamp 12 in the clamping station 83 between the front section 81 and the rear section 82 of the valve test section 8, step on the air pump 801, inflate the air seal ring 84, and complete the sealing of the valve test section 8. Open all valves, inject test medium into the medium storage tank 2, open the exhaust valve 85 for exhaust, and when the entire forward flow test circuit A is filled with liquid and the liquid level in the medium storage tank 2 is higher than the inlet height of the medium storage tank 2, stop injecting liquid. Close valve six B1 and valve seven B2 to make the regurgitant test circuit B in an open circuit state, open the operation interface of the controller 10, run the program, register the test related information (operator, test medium, etc.), start the motor, select the forward flow test, and the system will automatically open electromagnetic valve one 9021 and electromagnetic valve two 9022 at both ends of differential pressure sensor two 902, so that differential pressure sensor two 902 is connected to the system (the forward flow transvalve pressure difference is small, and differential pressure sensor two 902 with a smaller range is used for detection to reduce the error). Continue to select a test point with a flow rate of 5 L / min, and the system will automatically adjust the flow rate to 5 L / min. Differential pressure sensor four 904 measures the pressure difference before and after the forward flow nozzle A0, and the system flow rate can be obtained through the forward flow nozzle A0 flow rate-pressure difference calibration curve. Observe the flow rate fluctuation curve of the operation interface, and when the data is stable, click the data acquisition button to collect the transvalve pressure difference of the measured valve 800 measured by differential pressure sensor two 902. The program internally sets the calculation formula of the effective valve orifice area, and the effective valve orifice area of the measured valve 800 can also be obtained. After completing a test point, continue to select test points with flow rates of 10 L / min, 15 L / min, 20 L / min, 25 L / min, and 30 L / min, until all test points are completed. Data acquisition, output test report, stop program, and close operation interface. If the test continues, click the stop button to replace the measured valve 800.

[0123] Further, the regurgitant test circuit B includes a regurgitant nozzle B0, a differential pressure sensor three 903, a valve six B1, and a valve seven B2. The valve seven B2, the regurgitant nozzle B0, and the valve six B1 are connected in sequence, and the differential pressure sensor three 903 is connected in parallel with the regurgitant nozzle B0. The differential pressure sensor three 903 is connected to the controller 10.

[0124] When testing the artificial heart valve, according to the test requirements given in the standard ISO5840-2021, the leakage flow rates corresponding to five equidistant valve reverse pressure differences are measured in the reverse pressure difference range of 5.2 kPa to 26 kPa (40 mmHg-200 mmHg). For example, Figures 5-6As shown, the specific test is as follows: select the measured valve 800, reversely install the measured valve 800 into the corresponding valve clamp 12, and install the valve clamp 12 in the clamping station 83 between the front section 81 and the rear section 82 of the valve test section 8, step on the inflation pump 801, inflate the air sealing ring 84, and complete the sealing of the valve test section 8. Open all the valves, inject the test medium into the medium storage tank 2, open the exhaust valve 85, and when the entire regurgitation test loop B is filled with liquid and the liquid level in the medium storage tank 2 is higher than the inlet height of the medium storage tank 2, stop injecting liquid. (If the regurgitation test is performed after the forward flow test is completed, directly close the valves four A1 and five A2 at both ends of the forward flow nozzle A0, open the valves six B1 and seven B2 at both ends of the regurgitation nozzle B0, and reverse the measured valve 800 for replacement.) Close the valves four A1 and five A2, prepare for the regurgitation test, open the operation interface of the controller 10, run the program, register the test related information (operator, test medium, etc.), select the regurgitation test, the system will automatically close the electromagnetic valve one 9021 and the electromagnetic valve two 9022 at both ends of the differential pressure sensor two 902, so that the differential pressure sensor two 902 is disconnected from the system (the regurgitation transvalvular pressure difference is large, the differential pressure sensor one 901 with a larger range is used for detection to reduce the error; if the transvalvular pressure difference is too large, the differential pressure sensor will be damaged). Select the test point of 40mmHg transvalvular pressure difference, start the pump 3, and the differential pressure sensor one 901 can measure the transvalvular pressure difference of the measured valve 800. At this time, if the reading of the differential pressure sensor one 901 deviates from the set test point of 40mmHg, the system automatically adjusts the working parameters of the pump 3 until the transvalvular pressure difference of the valve is adjusted to 40mmHg. Observe the transvalvular pressure difference fluctuation curve of the operation interface, and after the data is stable, click the data acquisition button to acquire the front and rear pressure difference of the regurgitation nozzle B0 measured by the differential pressure sensor three 903. The system flow can be obtained through the nozzle flow-pressure difference calibration curve. After completing one test point, continue to select the test points of 80mmHg, 120mmHg, 160mmHg and 200mmHg transvalvular pressure difference, until the data acquisition of all test points is completed, and the test report is output. Stop the program and close the operation interface. If the test continues, click the stop button to replace the measured valve 800. As for the "small forward flow transvalvular pressure difference and large regurgitation transvalvular pressure difference" mentioned above, the explanation is as follows: it is formed due to objective factors. The heart valve is similar to a one-way valve. The forward flow (i.e. when the blood flows forward, the pressure required to open the valve is small, and when it flows backward, the valve is closed, but there is still blood flowing out of the valve edge gap objectively), which is the significance of the forward flow and regurgitation test of the present application.In addition, the main difference between the forward flow nozzle A0 and the return flow nozzle B0 in structure is that the aperture of the forward flow nozzle port A01 is larger than that of the return flow nozzle port B01, which is to adapt to the blood flow characteristics, i.e. due to the large forward flow, a larger flow area is required, while the return flow is smaller, and a smaller flow area is adopted.

[0125] As Figure 12 , the valve test section 8 includes a front section 81, a rear section 82 and a valve clamp 12, the front section 81 and the rear section 82 are oppositely arranged, a clamping station 83 adapted to the valve clamp 12 is formed between the front section 81 and the rear section 82, the valve clamp 12 is clamped in the clamping station 83, the top surfaces of the front section 81 and the rear section 82 are respectively provided with an exhaust valve 85, the opposite surfaces of the front section 81 and the rear section 82 are respectively provided with an inflation sealing ring 84 corresponding to the valve clamp 12, and the inflation sealing ring 84 is connected with an inflation pump 801.

[0126] The present application preferably provides four kinds of valve clamps 12, which are T-shaped clamps 121, as shown in Figures 13-15 The T-shaped clamp 121 includes a sheet-shaped body and a lifting ring 1212, a hole for accommodating the measured valve 800 is formed in the center of the sheet-shaped body, and a silica gel sleeve 1211 is further arranged between the measured valve 800 and the hole. The bottom of the lifting ring 1212 is provided with a rectangular bottom plate, and the bottom plate is provided with a positioning column. When the T-shaped clamp 121 is used, the positioning column is inserted into the positioning hole arranged on the front section 81 and the rear section 82, the T-shaped clamp 121 is installed into the clamping station 83, and the valve clamp is clamped and sealed after the inflation sealing ring 84 is inflated by stepping on the inflation pump 801.

[0127] As Figures 16-18As shown, the valve clamp is a rotary disc clamp 122, which includes a rotary disc body and a rotary disc support 1222. The rotary disc body is provided with a central rotating shaft 1223, which is movably connected to the rotary disc support 1222. The rotary disc support 1222 is fixedly arranged on the top surface of the front section 81 or the rear section 82. A plurality of accommodating holes 1224 are arranged on the rotary disc body at the same circumference. The outer circle of the measured valve 800 is sleeved with a silica gel sleeve two 1221, which is arranged in the accommodating hole. When the rotary disc clamp 122 is used, the plurality of measured valves 800 are placed in the hole positions on the rotary disc body, and then the rotary disc body is installed into the clamping station 83. The rotary disc clamp 122 has the characteristic that in the same flow test, only the inflation sealing ring 84 is exhausted by the inflation pump 801 (the inflation pump 801 and the inflation sealing ring 84 are connected by an air nozzle, and the air nozzle is pressed to exhaust), and then the next measured valve 800 is rotated to enter the clamping station 83, and then the inflation sealing ring 84 is inflated by pressing the inflation pump 801, so as to clamp and seal the valve clamp, thereby improving the test efficiency. In order to realize the locking characteristic of the rotary disc clamp 122, a positioning pin 12221 axially movable is arranged on the rotary disc support 1222. A plurality of positioning holes 1225 are uniformly distributed on the outer side of the central rotating shaft 1223 of the rotary disc body. The positioning pin 12221 is used for locking the rotary disc body. It should be noted that the positioning pin 12221 can be axially pulled out and inserted under manual operation. Of course, the positioning hole 1225 and the positioning pin 12221 constitute a positioning and locking structure corresponding to the indexing position of the accommodating hole.

[0128] As shown in Figures 19-21 , the valve clamp is a buckle clamp 123, which includes a buckle one 1232, an upper box cover 1233, a lower box cover 1234 and a hinge 1235. One side of the upper box cover 1233 and the lower box cover 1234 is respectively fixedly connected to the upper and lower hinge pieces of the hinge 1235. The other side of the upper box cover 1233 and the lower box cover 1234 is fixedly connected to the buckle one 1232. A semicircular hole for accommodating the measured valve 800 is arranged between the upper box cover 1233 and the lower box cover 1234. A positioning groove 1236 is arranged on the semicircular hole. A positioning silica gel sleeve 1231 adapted to the positioning groove 1236 is sleeved on the outer circle of the measured valve 800. When the buckle clamp 123 is used, the measured valve 800 is placed in the positioning silica gel sleeve 1231, the positioning silica gel sleeve 1231 is placed in the positioning groove 1236, the buckle one 1232 on the upper box cover 1233 and the lower box cover 1234 is closed, and then the buckle clamp 123 is inserted into the clamping station 83.

[0129] As shown in Figures 22-24As shown, the valve clamp is a split clamp 124, which includes a gasket 1242, a buckle two 1243, and a clamp box 1244. The clamp box 1244 is a split structure, and a hole for accommodating the measured valve 800 is formed in the center of the clamp box 1244. The measured valve 800 is sleeved with a silica gel sleeve three 1241 between the hole. The two sides of the clamp box 1244 are provided with gasket holes with a diameter larger than the hole, and the gasket holes are provided with the gasket 1242. When the split clamp 124 is used, the measured valve 800 is placed in the silica gel sleeve three 1241, the buckle two 1243 is closed, and then the split clamp 124 is inserted into the clamping station 83.

[0130] The above four kinds of valve clamps 12 are all sealed by inflating the inflatable sealing ring 84 by pressing the inflation pump 801 before testing, and then clamping the valve clamp 12. During testing, the measured valve 800 is replaced in the direction or removed by exhausting the inflation pump 801 after testing.

[0131] A steady flow test method for a prosthetic heart valve, the prosthetic heart valve is loaded into a valve clamp, the system is started, and then the following steps are performed:

[0132] 1), forward flow test,

[0133] 1.1), preparation before testing,

[0134] 1.1.1), the measured valve 800 is installed to the valve test section 8,

[0135] Select the target measured valve 800, assemble it in the valve clamp 12 in the forward direction, fix the valve clamp 12 in the valve test section 8, and seal the sealing position of the valve test section 8 by pressing the inflation pump 801,

[0136] 1.1.2), the circulating pipeline is filled with liquid, all manual ball valves are opened, the pump 3 is started, and the test liquid is injected into the circulating pipeline until the pipeline is completely filled, and the liquid level of the medium storage tank 2 is higher than the inlet end, and the liquid level of the energy storage medium tank 4 is higher than the outlet end,

[0137] 1.1.3), valve control, close valve six B1 and valve seven B2, so that the regurgitation test loop B is in an open circuit state, and the forward flow test is prepared,

[0138] 1.2), start testing,

[0139] 1.2.1), parameter setting, filling in the test related information in the operation interface, such as the valve 800 number to be tested, test date, etc., selecting the specification of the valve 800 to be tested, and selecting the test flow rate in turn, the specific parameters are: 5 L / min, 10 L / min, 15 L / min, 20 L / min, 25 L / min and 30 L / min, in the case of flow range 5 L / min to 30 L / min, with 5 L / min as the increment, the transvalvular pressure difference of the forward flow of the valve to be tested is measured.

[0140] 1.2.2), flow parameter, the flow rate through the pressure difference-flow rate calculation formula of the forward flow test nozzle, the formula is as follows:

[0141]

[0142] In the formula: Q 前 is the real-time flow rate of the forward flow valve to be tested, the unit is m 3 / s,

[0143] C is the flow coefficient, the value range is: 0.9-0.99,

[0144] A 前 is the forward flow nozzle orifice area, the unit is m 2 ,

[0145] is the pressure difference of the forward flow nozzle, the unit is Pa, collected by the pressure difference sensor four 904,

[0146] is the test liquid density, the unit is: kg / m 3 ,

[0147] The forward flow nozzle calibration curve is as follows: Figure 25 From the figure, it can be seen that: by fitting the curve with the calibration data points, the pressure difference-flow relationship of the forward flow nozzle is obtained, and then the flow rate of the forward flow can be obtained by collecting the pressure difference of the forward flow nozzle. 1.2.3), read the forward transvalvular pressure difference: the transvalvular pressure difference ΔP 前 of the valve is monitored and collected in real time by the pressure difference sensor two 902, the sensor measurement accuracy meets the latest standard requirements (error range ≤±0.26 kPa), and the minimum measurement accuracy of all other measuring devices should be within the range of ±5% of the full scale reading (for example: the accuracy of the flow meter is ±1.5 l / min).

[0148] 1.2.4), effective valve orifice area calculation: according to the flow-pressure difference relationship, the effective valve orifice area of the valve to be tested 800 is derived by the following formula,

[0149]

[0150] In the formula: EOA is the effective valve orifice area, in cm². 2 ,

[0151] q vRMS During periods of positive pressure differential, Q 前 The root mean square, in ml / s.

[0152] For Δp ​​during positive pressure differential 前 The average value, in mmHg.

[0153] The density of the test solution is given in g / cm³. 3 ;

[0154] The valve's Δp during a positive pressure differential was obtained in a steady-state forward flow test. 前 average The core purpose of these two parameters, effective valve area (EOA), is to assess the blood flow resistance and throughput of the valve, and to evaluate whether it can meet the physiological needs of the human body; to provide reliable performance basis for valve design optimization and clinical application.

[0155] 2) Valve replacement procedure:

[0156] System isolation and pressure relief: Close valve 2 602 and valve 3 603 to cut off the fluid passage of the test circuit and prevent excessive loss of test solution in the pipeline. Release the air from the air-filled sealing ring 84.

[0157] Fixture removal and replacement: Remove the tested valve fixture 12 and replace the target valve (verify the valve model and assembly direction markings).

[0158] Reassemble the valve clamp 12 and seal it by stepping on the air pump 801 to ensure that there is no liquid leakage at the valve clamp 12 interface.

[0159] Test restart procedure: Open valve 2 (602) and valve 3 (603) to restore circulation in the pipeline. Refill and vent the liquid according to the pre-test preparation procedure. After confirming that the liquid levels in medium storage tank 2 and energy storage medium tank 4 meet the requirements, start the test program.

[0160] 3) Backflow test,

[0161] 3.1) Install the valve 800 to be tested in reverse into the valve clamp 12, fix the valve clamp 12 in the valve test segment 8, seal the sealing position of the valve test segment 8 by stepping on the air pump 801, and then fill the circulation tubing with fluid.

[0162] Valve and clamp assembly: Select the target valve 800 and fix it in the valve clamp 12 according to the reverse assembly requirements. Check the airtightness of the clamp sealing position by stepping on the air pump 801.

[0163] Fill the circulation line with liquid: open all manual ball valves, start pump 3, inject test liquid into the circulation line until the line is completely filled. Confirm that the liquid level in the medium storage tank 2 is higher than the inlet end, and the liquid level in the energy medium tank 4 is higher than the outlet end.

[0164] Valve control: close valve four A1 and valve five A2, ready for regurgitation test.

[0165] 3.2), start test

[0166] 3.2.1), parameter setting: fill in the test related information on the operation interface, such as the number of the tested valve 800, the test date, etc. Select the specification of the tested valve 800, and select the test transvalvular pressure difference in turn, the specific parameters are: 40 mmHg, 80 mmHg, 120 mmHg, 160 mmHg, 200 mmHg.

[0167] 3.2.2), transvalvular pressure difference parameter: regurgitation transvalvular pressure difference Δp of the valve 返 Real-time monitoring and acquisition by pressure difference sensor one 901, the sensor measurement accuracy meets the latest standard requirements.

[0168] 3.2.3), flow data acquisition: the flow is obtained by the pressure difference-flow calculation formula of the regurgitation nozzle B01, the formula is as follows:

[0169]

[0170] In the formula: Q 返 is the regurgitation flow, the unit is m 3 / s,

[0171] A 返 is the regurgitation nozzle orifice area, the unit is m 2 ;

[0172] is the pressure difference before and after the regurgitation nozzle, the unit is Pa, collected by pressure difference sensor three 903:

[0173] is the test liquid density, the unit is kg / m 3 ,

[0174] Through this step, the reverse transvalvular pressure difference Δp 返 of the valve is controlled, the pressure difference before and after the regurgitation nozzle is obtained, and according to the formula of step 3.2.3), the regurgitation flow Q 返 is calculated, and the regurgitation flow Q 返 is the "gold standard" parameter for evaluating the closing performance of the artificial heart valve, the purpose is to verify the closing integrity and structural reliability of the valve.

[0175] The calibration curve of the regurgitation nozzle is as follows: Figure 26 As can be seen from the figure: by fitting the curve with the calibration data points, the pressure difference flow relationship of the regurgitation nozzle is obtained, and then the flow of the regurgitation can be obtained by collecting the pressure difference of the regurgitation nozzle.

[0176] 4) Complete the test of a valve to be tested.

[0177] Batch test the valve, and repeat the foregoing steps.

[0178] Through the above test method of the present application, only one set of test device of the present application is needed, and the forward flow and regurgitation detection can be performed by switching the test circuit, and then the actual performance index of a single valve to be tested can be efficiently obtained. When batch testing is performed, the replacement of the valve to be tested can be quickly realized in one working state through the test fixture of the present application, the detection of a certain state of the batch product is completed, and then the test circuit is switched to perform the detection of another state of the batch product.

[0179] It should be noted that the above specific embodiments are only the preferred embodiments of the present application and the technical principles applied. Those skilled in the art should understand that various modifications, equivalent replacements, changes, etc. can be made to the present application on the basis of the technical content disclosed in the present application. However, as long as these changes do not deviate from the spirit of the present application, they should be within the protection scope of the present application. In addition, some terms used in the present application specification and claims are not limited, but only for the convenience of description.

Claims

1. A prosthetic heart valve steady flow testing device comprising a control loop and a circulation loop, the control loop comprising a controller (10), characterized in that, The circulation loop comprises a pump (3), an energy storage medium tank (4), a valve test loop, a forward flow test loop (A), a regurgitation test loop (B), a throttling branch (7) and a medium storage tank (2); The pump (3) is connected to the energy storage medium tank (4), the energy storage medium tank (4) is connected in parallel to the inlet of the throttling branch (7) and a valve two (602), the valve two (602) is connected to the inlet of the valve test loop, the outlet of the valve test loop is connected in parallel to the forward flow test loop (A) and the regurgitation test loop (B) through a valve three (603), and the forward flow test loop (A) and the regurgitation test loop (B) are connected to the outlet of the throttling branch (7) and the medium storage tank (2); A flow stabilizer (601) is further arranged in front of the valve two (602); The forward flow test loop (A) comprises a forward flow nozzle (A0), a differential pressure sensor four (904), a valve four (A1) and a valve five (A2), the valve five (A2), the forward flow nozzle (A0) and the valve four (A1) are connected in sequence, the differential pressure sensor four (904) is connected in parallel to the forward flow nozzle (A0); and the differential pressure sensor four (904) is connected to the controller (10); The regurgitation test loop (B) comprises a regurgitation nozzle (B0), a differential pressure sensor three (903), a valve six (B1) and a valve seven (B2), the valve seven (B2), the regurgitation nozzle (B0) and the valve six (B1) are connected in sequence, the differential pressure sensor three (903) is connected in parallel to the regurgitation nozzle (B0); and the differential pressure sensor three (903) is connected to the controller (10); The aperture of a forward flow nozzle port (A01) of the forward flow nozzle (A0) is larger than the aperture of a regurgitation nozzle port (B01) of the regurgitation nozzle (B0).

2. The steady flow testing device for a prosthetic heart valve of claim 1, wherein, The valve test loop comprises a valve test section (8), an electromagnetic valve one (9021), an electromagnetic valve two (9022), a differential pressure sensor two (902) and a differential pressure sensor one (901), and a valve clamp (12), The electromagnetic valve one (9021), the differential pressure sensor two (902) and the electromagnetic valve two (9022) are connected in sequence, and are connected in parallel to the differential pressure sensor one (901) and the valve test section (8); The electromagnetic valve one (9021), the electromagnetic valve two (9022), the differential pressure sensor two (902) and the differential pressure sensor one (901) are respectively connected to the controller (10).

3. The steady flow test device for a prosthetic heart valve of claim 2, wherein, The valve test section (8) comprises a front section (81), a rear section (82) and a valve clamp (12), the front section (81) and the rear section (82) are oppositely arranged, a clamping station (83) adapted to the valve clamp (12) is formed between the front section (81) and the rear section (82), the valve clamp (12) is clamped in the clamping station (83), the top surface of the front section (81) and the top surface of the rear section (82) are respectively provided with an exhaust valve (85), the opposite surface of the front section (81) and the opposite surface of the rear section (82) are respectively provided with an inflation sealing ring (84) corresponding to the valve clamp (12), and the inflation sealing ring (84) is connected with an inflation pump (801).

4. The steady flow testing device for a prosthetic heart valve of claim 3, wherein, The valve clamp is a T-shaped clamp (121), the T-shaped clamp (121) comprises a sheet-shaped body and a lifting ring (1212), a hole for accommodating a measured valve (800) is formed in the center of the sheet-shaped body, and a silica gel sleeve one (1211) is further arranged between the measured valve (800) and the hole.

5. The steady flow testing device for a prosthetic heart valve of claim 3, wherein, The valve clamp is a rotary disc clamp (122), the rotary disc clamp (122) comprises a rotary disc body and a rotary disc support (1222), the rotary disc body is provided with a central rotating shaft (1223), the central rotating shaft (1223) is movably connected with the rotary disc support (1222), and the rotary disc support (1222) is fixedly arranged on the top surface of the front section (81) or the rear section (82); a plurality of accommodating holes (1224) in the same circumference are arranged on the rotary disc body, an outer circle of a measured valve (800) is sleeved with a silica gel sleeve two (1221), and the silica gel sleeve two (1221) is arranged in the accommodating hole.

6. The steady flow testing device for a prosthetic heart valve of claim 5, wherein, An axially movable positioning pin (12221) is arranged on the rotary disc support (1222), a plurality of positioning holes (1225) are uniformly distributed on the outer side of the central rotating shaft (1223) of the rotary disc body, and the positioning pin (12221) is used for locking the rotary disc body.

7. The steady flow testing device for a prosthetic heart valve of claim 3, wherein, The valve clamp is a buckle type clamp (123), the buckle type clamp (123) comprises a buckle one (1232), an upper box cover (1233), a lower box cover (1234) and a hinge (1235), one side of the upper box cover (1233) and one side of the lower box cover (1234) are respectively fixedly connected to the upper hinge leaf and the lower hinge leaf of the hinge (1235), the other side of the upper box cover (1233) and the other side of the lower box cover (1234) are fixedly connected with the buckle one (1232), semicircular holes for accommodating a measured valve (800) are respectively arranged between the upper box cover (1233) and the lower box cover (1234), positioning grooves (1236) are arranged on the semicircular holes, and an outer circle of the measured valve (800) is sleeved with a positioning silica gel sleeve (1231) matched with the positioning grooves (1236).

8. The steady flow testing device for a prosthetic heart valve of claim 3, wherein, The valve clamp is an open-close clamp (124), the open-close clamp (124) includes a gasket (1242), a buckle two (1243) and a clamp box (1244), the clamp box (1244) is left-right open-close structure, the center of the clamp box (1244) is provided with a hole for accommodating the measured valve (800), the measured valve (800) is sleeved with a silica gel sleeve three (1241) between the hole, the both sides of the clamp box (1244) are provided with gasket holes with a diameter greater than the hole, and the gasket holes are provided with the gasket (1242).

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