Real-time wear testing apparatus for cardiovascular implant mitral or tricuspid valve

Abstract

The present application relates to a kind of real-time wear test device for cardiovascular implant bicuspid valve / tricuspid valve, including multiple test mechanisms, test mechanism includes first compliance adjustment module, second compliance adjustment module, liquid flow pipeline and drive module, second compliance adjustment module is connected with valve carrier module and reflux pipe between first compliance adjustment module;Liquid flow pipeline one end is communicated with first compliance adjustment module, the other end is connected with drive module;Test liquid sequentially flows through liquid flow pipeline, first compliance adjustment module, reflux pipe, second compliance adjustment module and valve carrier module, and reflux to first compliance adjustment module and liquid flow pipeline, to carry out cyclic reciprocating motion.The present application can simulate the test environment of highly approximate human physiological condition, to ensure the reliability and accuracy of bicuspid valve and tricuspid valve test result, provide real and reliable basis for evaluating the service life of bicuspid valve and tricuspid valve.

Description

Technical Field

[0001] This invention belongs to the field of mitral and tricuspid valve wear testing technology, specifically relating to a real-time wear testing device for cardiovascular implants, specifically mitral or tricuspid valves. Background Technology

[0002] The human heart has four valves, classified according to blood flow direction: aortic / pulmonary valve and mitral / tricuspid valve. When conducting real-time wear testing on artificial heart valves, it is necessary to closely simulate human physiological conditions, such as physiological pressure curves and human pulse rate. These are not merely devices that provide fluid circulation, but rather tests the dynamic opening and closing of the artificial heart valve under these conditions over extended periods.

[0003] Most testing equipment for the mitral and tricuspid valves on the market can only simulate fluid pulsation circulation, but cannot provide a good approximation of human physiological conditions. For example, how to ensure that the valves open and close normally at a frequency similar to human pulsation, and that the pressure curves before and after valve opening and closing match the corresponding physiological curves. If the above conditions cannot be met, the reliability and accuracy of the test results obtained will be poor, and thus the service life of the mitral / tricuspid valves cannot be accurately assessed. Summary of the Invention

[0004] The purpose of this invention is to provide a real-time wear testing device for cardiovascular implants, such as mitral or tricuspid valves, to solve the problem of poor accuracy in wear test results.

[0005] The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants of the present invention is implemented as follows:

[0006] A real-time wear testing device for cardiovascular implants, specifically mitral or tricuspid valves, includes multiple testing mechanisms arranged side-by-side, wherein the testing mechanisms include...

[0007] First compliance adjustment module;

[0008] The second compliance adjustment module is connected to the first compliance adjustment module by a valve carrier module and a reflux tube;

[0009] A liquid flow conduit, one end of which is connected to the first compliance adjustment module;

[0010] A drive module, which is connected to the other end of the liquid flow pipe, is used to provide power to the test liquid in the test mechanism;

[0011] The test liquid flows sequentially through the liquid flow pipe, the first compliance adjustment module, the return pipe, the second compliance adjustment module, and the valve carrier module, and then flows back to the first compliance adjustment module and the liquid flow pipe to perform a cyclical motion.

[0012] Furthermore, the first compliance adjustment module includes a first adjustment box that is respectively connected to the valve carrier module, the reflux tube, and the liquid flow pipe;

[0013] A one-way valve is installed in the inner cavity of the first regulating box body, which is used to connect the valve carrier module and the return pipe.

[0014] A first rectifier valve plate is provided on the lower side of the one-way valve;

[0015] The top of the first regulating box is provided with a first exhaust switch;

[0016] The bottom of the first regulating box is provided with a drain outlet;

[0017] The first adjustment box body has a first observation window corresponding to the valve carrier module on the side opposite to the valve carrier module;

[0018] The first regulating box has a second observation window corresponding to the return pipe on the side opposite to the return pipe.

[0019] Furthermore, the second compliance adjustment module includes a second adjustment box that is connected to the valve carrier module and the reflux tube respectively;

[0020] The bottom of the second adjustment box is equipped with a damping adjustment component;

[0021] The damping adjustment assembly includes an energy cavity disposed at the bottom of the second adjustment box, a diaphragm disposed between the second adjustment box and the energy cavity, and a spring disposed below the diaphragm;

[0022] The top of the second regulating box is provided with a liquid storage chamber communicating with its interior, and a second exhaust switch is provided on the liquid storage chamber.

[0023] Furthermore, a throttling valve and a second rectifier valve plate are installed in the inner cavity of the second regulating box, which is used to connect the valve carrier module and the return pipe.

[0024] Furthermore, the valve carrier module includes an outflow clamp connected to the first compliance adjustment module, an inflow clamp connected to the second compliance adjustment module, and a valve carrier installed between the outflow clamp and the inflow clamp, with the cardiovascular implant placed inside the valve carrier;

[0025] Pressure sensors are installed on the outflow end clamp and the inflow end clamp, respectively.

[0026] Furthermore, the reflux tube is positioned above the valve carrier module, and a reflux throttling valve is installed on the reflux tube.

[0027] Furthermore, the liquid flow conduit is located below the valve carrier module;

[0028] The liquid flow pipeline includes a first flow pipeline connected to the drive module, and a second flow pipeline that is telescopically disposed at the free end of the first flow pipeline and connected to the first compliance adjustment module.

[0029] Furthermore, the drive module includes a drive component, a sliding sleeve installed at the power output end of the drive component, and a pusher located inside the sliding sleeve and connected to the power output rod of the drive component, with the inner cavity of the sliding sleeve opposite to the pusher communicating with the liquid flow pipe.

[0030] The driving component is a voice coil motor or a cylinder.

[0031] Furthermore, the liquid flow pipes of each test unit are all mounted on a main board, which is provided with a first through hole for connecting the corresponding liquid flow pipe to the drive module;

[0032] A heating plate is provided on the side of the motherboard facing the drive module.

[0033] Furthermore, the drive module has a connecting sleeve on the side facing the motherboard that is internally connected to the corresponding liquid flow pipe. The top of the connecting sleeve is provided with an exhaust hole, and a lower exhaust connector is installed on the exhaust hole. The top of the motherboard is provided with an exhaust chamber, and an upper exhaust connector is installed on the side of the exhaust chamber. The lower exhaust connector and the upper exhaust connector are connected through an air pipe. A third exhaust switch is provided on the top of the exhaust chamber.

[0034] After adopting the above technical solution, the beneficial effects of the present invention are as follows:

[0035] This invention, through the cooperation of a first compliance adjustment module, a second compliance adjustment module, a valve carrier module, a reflux tube, a liquid flow tube, and a drive module, enables the test liquid to circulate repeatedly within it, thereby simulating a test environment that closely approximates human physiological conditions. This ensures the reliability and accuracy of mitral / tricuspid valve test results and provides a true and reliable basis for evaluating the service life of the mitral / tricuspid valve. Attached Figure Description

[0036] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0037] Figure 1 This is a structural diagram from a first-view perspective of a preferred embodiment of the real-time wear testing device for cardiovascular implants, specifically the mitral or tricuspid valve.

[0038] Figure 2This is a structural diagram from a second perspective of a preferred embodiment of the real-time wear testing device (without housing) for cardiovascular implants, specifically the mitral or tricuspid valve.

[0039] Figure 3 This is a cross-sectional view of the first compliance adjustment module of a real-time wear testing device for a cardiovascular implant, the mitral or tricuspid valve, according to a preferred embodiment of the present invention.

[0040] Figure 4 This is a cross-sectional view of the second compliance adjustment module of a real-time wear testing device for mitral or tricuspid valves of cardiovascular implants according to a preferred embodiment of the present invention.

[0041] Figure 5 This is an exploded view of the valve carrier module of a real-time wear testing device for mitral or tricuspid valves of cardiovascular implants according to a preferred embodiment of the present invention.

[0042] Figure 6 This is an exploded view of the liquid flow channel of a real-time wear testing device for mitral or tricuspid valves of cardiovascular implants according to a preferred embodiment of the present invention.

[0043] Figure 7 This is an exploded view of the drive module, heating plate, and main board of a real-time wear testing device for mitral or tricuspid valves of cardiovascular implants according to a preferred embodiment of the present invention.

[0044] Figure 8 This is a cross-sectional view of the drive module, heating plate, and main board of a real-time wear testing device for mitral or tricuspid valves of cardiovascular implants according to a preferred embodiment of the present invention.

[0045] In the diagram: First compliance adjustment module 1, first adjustment box 1-1, valve block 1-2, base cover 1-3, first valve carrier interface 1-4, first return pipe interface 1-5, one-way valve 1-6, first exhaust switch 1-7, drain outlet 1-8, first observation window 1-9, second observation window 1-10, first flow pipe interface 1-11, first rectifier valve plate 1-12; Second compliance adjustment module 2, second adjustment box 2-1, second return pipe interface 2-2, second valve carrier interface 2-3, energy chamber 2-4, diaphragm 2-5, spring 2-6, diaphragm clamp 2-7, spring base 2-8, damping adjustment valve 2-9, liquid storage chamber 2-10, second exhaust switch 2-11, throttle valve 2-12, second rectifier valve plate 2-13, liquid. Flow pipe 3, first flow pipe 3-1, second flow pipe 3-2, drive module 4, voice coil motor 4-1, sliding sleeve 4-2, pusher 4-3, motor bracket 4-4, connecting sleeve 4-5, exhaust port 4-6, lower exhaust connector 4-7, valve carrier module 5, outflow end clamp 5-1, inflow end clamp 5-2, valve carrier 5-3, receiving cavity 5-4, pressure sensor 5-5, return pipe 6, return throttle valve 6-1, high-speed camera mechanism 7, light source fixing block 7-1, light source 7-2, camera 7-3, camera bracket 7-4, support rod 8, housing 9, housing base 10, main board 11, first through hole 11-1, exhaust cavity 11-2, upper exhaust connector 11-3, third exhaust switch 11-4, heating plate 12, second through hole 12-1. Detailed Implementation

[0046] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0047] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0048] like Figure 1-8As shown, a real-time wear testing device for mitral or tricuspid valves used in cardiovascular implants includes multiple testing mechanisms arranged side-by-side. Each testing mechanism includes a first compliance adjustment module 1, a second compliance adjustment module 2, a liquid flow channel 3, and a drive module 4. A valve carrier module 5 and a return tube 6 are connected between the second compliance adjustment module 2 and the first compliance adjustment module 1. One end of the liquid flow channel 3 is connected to the first compliance adjustment module 1. The drive module 4 is connected to the other end of the liquid flow channel 3 and is used to provide power for the test liquid within the testing mechanism. The test liquid flows sequentially through the liquid flow channel 3, the first compliance adjustment module 1, the return tube 6, the second compliance adjustment module 2, and the valve carrier module 5, and then returns to the first compliance adjustment module 1 and the liquid flow channel 3 to perform cyclic reciprocating motion.

[0049] Each testing unit forms a testing channel for testing one test valve. In this embodiment, three testing units are arranged side by side, allowing simultaneous testing of three test valves. However, the number of testing units is not limited to the three used in this embodiment; the number can be adjusted as needed.

[0050] The first compliance adjustment module 1, the return pipe 6, the second compliance adjustment module 2, and the valve carrier module 5 form a circulating flow channel, and the drive module 4 provides power to the test liquid in the circulating flow channel through the liquid flow pipe 3.

[0051] In order to form a circulating flow channel, the first compliance adjustment module 1 includes a first adjustment box 1-1 that is connected to the valve carrier module 5, the return pipe 6 and the liquid flow pipe 3 respectively.

[0052] The first regulating box 1-1 has an opening at the top and bottom, with its top closed by valve block 1-2 and its bottom closed by base cover plate 1-3.

[0053] The first adjustment box 1-1 has a first valve carrier interface 1-4 for connecting the valve carrier module 5 and a first reflux tube interface 1-5 for connecting the reflux tube 6 on the side facing the second compliance adjustment module 2. The first reflux tube interface 1-5 and the first valve carrier interface 1-4 are located on the same side of the first adjustment box 1-1, and the first reflux tube interface 1-5 is located above the first valve carrier interface 1-4.

[0054] During the test, the test liquid flows from the first regulating chamber 1-1 into the return pipe 6, then into the second compliance regulating module 2, and finally flows back to the first regulating chamber 1-1 through the valve carrier module 5. In order to control the flow direction of the test liquid during the above process, a one-way valve 1-6 is installed in the inner cavity of the first regulating chamber 1-1 that connects the valve carrier module 5 and the return pipe 6.

[0055] The valve carrier module 5 is located below the reflux pipe 6. The one-way valve 1-6 is a valve body that only allows the test liquid to flow from bottom to top, thereby controlling the flow direction of the test liquid as follows: first regulating box 1-1 - reflux pipe 6 - second compliance regulating module 2 - valve carrier module 5 - first regulating box 1-1.

[0056] A first rectifier valve plate 1-12 is provided on the lower side of the one-way valve 1-6.

[0057] The valve block 1-2 at the top of the first regulating box 1-1 extends into the inner cavity of the first regulating box 1-1 and extends to the lower side of the first return pipe interface 1-5. The valve block 1-2 is provided with a cavity that communicates with the inner cavity of the first regulating box 1-1 to ensure that the test liquid smoothly enters the return pipe 6. The first rectifier valve plate 1-12 is fixed to the bottom of the valve block 1-2 using screws and other connecting parts. The one-way valve 1-6 is installed on the upper side of the first rectifier valve plate 1-12. In this way, the first rectifier valve plate 1-12 and the one-way valve 1-6 can be inspected and replaced when the valve block 1-2 is disassembled, making the operation more convenient.

[0058] The first rectifier valve plate 1-12 can improve the velocity distribution of the test liquid, reduce turbulence and vortices, and lower flow resistance.

[0059] When injecting test liquid into the test mechanism, a first exhaust switch 1-7 is provided on the top of the first regulating chamber 1-1 to facilitate the discharge of gas inside the first regulating chamber 1-1.

[0060] The first exhaust switch 1-7 is installed on the valve body block 1-2.

[0061] To facilitate the drainage of the test liquid after the test, a drain outlet 1-8 is provided at the bottom of the first regulating chamber 1-1.

[0062] Drainage outlets 1-8 are located at the bottom of base cover plates 1-3.

[0063] In order to facilitate observation of the test condition of the test valve in the valve carrier module 5 during the test, the first adjustment box 1-1 is provided with a first observation window 1-9 corresponding to the valve carrier module 5 on the side opposite to the valve carrier module 5.

[0064] In order to observe the corresponding test conditions through the first observation window 1-9, the test device also includes a high-speed camera mechanism 7 that is fitted to the first observation window 1-9. The high-speed camera mechanism 7 includes a light source fixing block 7-1 mounted outside the first observation window 1-9, a light source 7-2 mounted on the periphery of the light source fixing block 7-1, and a camera 7-3 facing the outside of the light source fixing block 7-1. The camera 7-3 is fixed on a camera bracket 7-4 at the outer end of the light source fixing block 7-1.

[0065] The high-speed camera mechanism 7 is a movable device that can be switched between different test mechanisms of the test apparatus and placed on the test mechanism that needs to be observed as needed.

[0066] Among them, the camera 7-3 can be a high frame rate vision industrial camera 7-3, supplemented by a light source 7-2, software and other control systems. The lens passes through the first observation window 1-9 to record and observe the opening and closing of the test valve in real time, and is connected to a computer through a data communication line to analyze, record and save the collected data.

[0067] In order to facilitate the flow of the test liquid in the reflux pipe 6 during the test, a second observation window 1-10 corresponding to the reflux pipe 6 is provided on the side of the first regulating box 1-1 away from the reflux pipe 6.

[0068] Regarding the situation inside the reflux pipe 6, the operator can make a visual inspection directly through the second observation window 1-10 without the aid of cameras 7-3, etc.

[0069] In order to form a circulating flow channel, the second compliance adjustment module 2 includes a second adjustment box 2-1 that is connected to the valve carrier module 5 and the reflux tube 6 respectively.

[0070] The second regulating box 2-1 has a second reflux pipe interface 2-2 and a second valve carrier interface 2-3 arranged sequentially from top to bottom on the side facing the first regulating box 1-1, so as to connect the reflux pipe 6 and the valve carrier module 5.

[0071] In order to receive and store the energy generated by the drive module 4 driving the liquid flow, a damping adjustment component is provided at the bottom of the second regulating box 2-1.

[0072] Specifically, the damping adjustment assembly includes an energy cavity 2-4 disposed at the bottom of the second adjustment housing 2-1, a diaphragm 2-5 disposed between the second adjustment housing 2-1 and the energy cavity 2-4, and a spring 2-6 disposed below the diaphragm 2-5.

[0073] The bottom of the second regulating box 2-1 is open. The energy cavity 2-4 is installed at the bottom of the second regulating box 2-1 by bolts. The diaphragm 2-5 is fixed between the second regulating box 2-1 and the energy cavity 2-4 by the diaphragm clamp 2-7. The spring 2-6 is installed in the energy cavity 2-4 below the diaphragm 2-5 and is positioned by the spring base 2-8.

[0074] After the drive module 4 pushes the test liquid into the second regulating chamber 2-1, the damping regulating component can receive the energy generated by the flow of the test liquid, causing the diaphragm 2-5 to deform downward and compress the spring 2-6 at the same time, forming an energy storage component. When the drive module 4 returns, the damping regulating component releases energy and pushes the test liquid through the test valve.

[0075] Preferably, a damping regulating valve 2-9 is threadedly installed at the bottom of the energy chamber 2-4, and two air holes are provided on its end face. Four air holes are also provided on the end face of the spring base 2-8. By rotating the damping regulating valve 2-9, the position of the two air holes is changed, so as to adjust the flow between the two air holes and the air holes on the end face of the spring base 2-8, thereby adjusting the energy chamber 2-4's ability to receive and buffer the test liquid.

[0076] In order to form an energy storage component on the top of the second regulating box 2-1, a liquid storage chamber 2-10 communicating with its interior is provided on the top of the second regulating box 2-1, and a second exhaust switch 2-11 is provided on the liquid storage chamber 2-10.

[0077] The top of the second regulating chamber 2-1 is also designed to be open. When the test liquid flows through the one-way valve 1-6 and enters the second regulating chamber 2-1 through the return pipe 6, the excess liquid will cause the liquid level in the storage chamber 2-10 to rise, thus making it a temporary energy storage component.

[0078] Before the test begins, when injecting the test liquid into the test mechanism, a second exhaust switch 2-11 is installed on the top of the liquid storage chamber 2-10 to facilitate the venting of air from the second regulating chamber 2-1.

[0079] A throttle valve 2-12 and a second rectifier valve plate 2-13 are installed in the inner cavity of the second regulating box 2-1, which is used to connect the valve carrier module 5 and the return pipe 6.

[0080] The throttle valve 2-12 is designed to adjust the degree of opening and closing of the test valve by changing the flow rate of the test liquid in the circulation channel.

[0081] To facilitate the installation of the throttle valve 2-12, the inner diameter of the inner cavity of the second regulating box 2-1 where the throttle valve 2-12 is located is smaller, forming a narrowed section, so as to facilitate the control of the flow rate of the test liquid. The throttle valve 2-12 is located on the side of the first regulating box 1-1, and its regulating end extends into the inner cavity of the narrowed section.

[0082] The second rectifier valve plate 2-13 has the same function as the first rectifier valve plate 1-12, namely, it can improve the velocity distribution of the test liquid, reduce turbulence and vortices, and lower flow resistance. The bottom of the narrowed section forms an end face, and the second rectifier valve plate 2-13 is mounted on this end face by screws or other fasteners, located below the throttle valve 2-12.

[0083] In order to install the test valve in the valve carrier module 5, the valve carrier module 5 includes an outflow clamp 5-1 connected to the first compliance adjustment module 1, an inflow clamp 5-2 connected to the second compliance adjustment module 2, and a valve carrier 5-3 installed between the outflow clamp 5-1 and the inflow clamp 5-2, with the cardiovascular implant placed inside the valve carrier 5-3.

[0084] The outflow clamp 5-1 is installed on the first valve carrier interface 1-4 of the first adjustment box 1-1, and a sealing ring is provided between them; the inflow clamp 5-2 is installed on the second valve carrier interface 2-3 of the second adjustment box 2-1, and a sealing ring is also provided between them. A receiving cavity 5-4 is provided on the opposite sides of the outflow clamp 5-1 and the inflow clamp 5-2. The valve carrier 5-3 is placed in the receiving cavity 5-4, and sealing rings are provided between the valve carrier 5-3 and both the inflow clamp 5-2 and the outflow clamp 5-1. The cardiovascular implant, i.e., the test valve, is placed in the valve carrier 5-3.

[0085] In order to test the pressure of the test liquid in the inflow clamp 5-2 and the outflow clamp 5-1 in real time, pressure sensors 5-5 are installed on the outflow clamp 5-1 and the inflow clamp 5-2 respectively.

[0086] Preferably, in order to ensure the stability between the first adjustment box 1-1 and the second adjustment box 2-1, a support rod 8 located on the periphery of the valve carrier module 5 is installed between the first adjustment box 1-1 and the second adjustment box 2-1.

[0087] The reflux tube 6 is positioned above the valve carrier module 5, and a reflux throttle valve 6-1 is installed on the reflux tube 6.

[0088] The two ends of the reflux tube 6 are respectively fitted at the first reflux tube 6 interface and the second reflux tube interface 2-2, and sealing rings are also installed between them to prevent leakage of the test liquid.

[0089] The reflux throttle valve 6-1 is used to regulate the flow rate of the test liquid in the circulation channel to adjust the degree of opening and closing of the test valve.

[0090] Preferably, the outer ring surface of the middle part of the return pipe 6 is a rectangular columnar structure, which makes the outer ring surface flat, thus facilitating the installation of the return throttle valve 6-1.

[0091] In order to transmit the power of the drive module 4 to the test liquid in the circulation channel, the liquid flow pipe 3 is located below the valve carrier module 5; the liquid flow pipe 3 includes a first flow pipe 3-1 connected to the drive module 4, and a second flow pipe 3-2 that is telescopically disposed at the free end of the first flow pipe 3-1 and connected to the first compliance adjustment module 1.

[0092] The first regulating box 1-1 has a first flow pipe interface 1-11 on its side facing the second regulating box 2-1. The end of the second flow pipe 3-2 is installed at the first flow pipe interface 1-11, and a sealing ring is provided between the two.

[0093] The two-section telescopic design of the liquid flow pipe 3 not only allows for adjustment of the length of the entire liquid flow pipe 3 as needed, but also facilitates the disassembly and assembly of the entire test mechanism and the replacement of the test valve.

[0094] Preferably, a sealing ring is provided on the outer wall of the second flow pipe 3-2 to ensure the sealing between the first flow pipe 3-1 and the second flow pipe 3-2.

[0095] In order to provide power to the test liquid, the drive module 4 includes a drive component, a sliding sleeve 4-2 installed at the power output end of the drive component, and a pusher 4-3 located inside the sliding sleeve 4-2 and connected to the power output rod of the drive component. The inner cavity of the sliding sleeve 4-2 away from the pusher 4-3 is connected to the liquid flow pipe 3.

[0096] Specifically, the drive modules 4 corresponding to each test mechanism are arranged side by side and installed in a housing 9. The power output rod of the drive component is set towards the first adjustment housing 1-1. The "H"-shaped silicone rubber pusher 4-3 is assembled (preferably threaded) on the power output rod, and the acrylic sliding sleeve 4-2 is fitted on the outer ring of the pusher 4-3. When the drive component is working, its power output rod can drive the pusher 4-3 to make reciprocating linear motion in the sliding sleeve 4-2 to provide power to the test liquid.

[0097] The driving component is either a voice coil motor 4-1 or a cylinder.

[0098] In this embodiment, the driving component is a voice coil motor 4-1.

[0099] Specifically, the voice coil motor 4-1 is fixed inside the enclosure 9 by two motor brackets 4-4, and the motor brackets 4-4 are fixed on the enclosure base 10.

[0100] In order to integrate the various test mechanisms into a whole test device, the liquid flow pipes 3 of each test mechanism are all mounted on a main board 11. The main board 11 is provided with a first through hole 11-1 for connecting the corresponding liquid flow pipe 3 with the drive module 4.

[0101] The end of the first flow pipe 3-1 is installed on the corresponding first through hole 11-1 so as to communicate with the inner cavity of the corresponding sliding sleeve 4-2 (the part facing the liquid flow pipe 3) through the first through hole 11-1.

[0102] To make the test environment closer to the internal temperature of the human body, a heating plate 12 is provided on the side of the motherboard 11 facing the drive module 4.

[0103] Specifically, the heating plate 12 is disposed between the drive module 4 and the main board 11, and the heating plate 12 is provided with a second through hole 12-1 for connecting the drive module 4 and the corresponding liquid flow pipe 3. The second through hole 12-1 is correspondingly disposed with the first through hole 11-1. That is, the inner cavity of the sliding sleeve 4-2 of the drive module 4 (the part facing the liquid flow pipe 3) is connected to the corresponding liquid flow pipe 3 through the second through hole 12-1 and the first through hole 11-1 in sequence. The power of the drive component can be transmitted to the liquid flow pipe 3 and the test liquid in the circulation channel through the pusher 4-3.

[0104] The two ends of the sliding sleeve 4-2 are respectively sealed to the heating plate 12 and the motor bracket 4-4 opposite to the heating plate 12.

[0105] Preferably, the heating plate 12 is made of aerospace aluminum material with an outer heating band, which has good thermal conductivity.

[0106] The heating element generates heat and transfers it to the internal liquid, thereby making the temperature of the test liquid in the test environment closer to the internal temperature of the human body and eliminating the influence of environmental temperature differences on the test.

[0107] The drive module 4 has a connecting sleeve 4-5 on the side facing the motherboard 11, which is internally connected to the corresponding liquid flow pipe 3. The top of the connecting sleeve 4-5 is provided with an exhaust hole 4-6, and a lower exhaust connector 4-7 is installed on the exhaust hole 4-6. The top of the motherboard 11 is provided with an exhaust chamber 11-2, and an upper exhaust connector 11-3 is installed on the side of the exhaust chamber 11-2. The lower exhaust connector 4-7 and the upper exhaust connector 11-3 are connected through an air pipe (not shown in the figure). The top of the exhaust chamber 11-2 is provided with a third exhaust switch 11-4.

[0108] The connecting sleeve 4-5 is designed to facilitate the installation of the sliding sleeve 4-2. The connecting sleeve 4-5, the sliding sleeve 4-2, and the voice coil motor 4-1 are configured in a one-to-one correspondence. The two ends of the sliding sleeve 4-2 are respectively sealed to the connecting sleeve 4-5 and the motor bracket 4-4 opposite to the connecting sleeve 4-5.

[0109] During the test, air bubbles are easily generated inside the connecting sleeve 4-5. In order to expel the air bubbles, an exhaust hole 4-6, an exhaust chamber 11-2, and a third exhaust switch 11-4 are provided. The gas inside the connecting sleeve 4-5 enters the exhaust chamber 11-2 through the exhaust hole 4-6 and the air pipe, and then exits from the test mechanism through the third exhaust switch 11-4.

[0110] The exhaust chamber 11-2 and the connecting sleeve 4-5 are set in a one-to-one correspondence, which not only facilitates the connection of the air pipe, but also improves the efficiency of gas discharge.

[0111] During the test, the voice coil motor 4-1 reciprocates at a human pulsation frequency of 1.2Hz or a test frequency of 3.3Hz. Its power output rod pushes the pusher 4-3 to reciprocate within the sliding sleeve 4-2, simulating the pulsating circulation of the human heart. When the voice coil motor 4-1 ejects liquid, the test liquid enters the valve carrier module 5 and the return pipe 6 through the first regulating chamber 1-1. Because the test valve is closed, the test liquid can only enter the first regulating chamber 1-1 through the return pipe 6, where it stores energy in the damping adjustment component and the reservoir 2-10. When the voice coil motor 4-1 returns, the energy in the damping adjustment component and the reservoir 2-10 is released. Due to the presence of the one-way valve 1-6, the test liquid can only flow back from the valve carrier module 5 (where the test valve is located) to the first regulating chamber 1-1 and the liquid flow pipe 3. During this process, the test valve opens. The voice coil motor 4-1 reciprocates to circulate the test fluid, while the test valve opens and closes at a specified frequency, demonstrating clinical behavior.

[0112] The experimental device described in this invention can create physiological conditions that closely resemble those required for human mitral / tricuspid valves, providing real-time dynamics of opening and closing at a frequency (human pulsation frequency) for the artificial heart valve mitral / tricuspid valve to be stable and reliable. It detects various parameters such as motion frequency, waveform, pressure, and temperature throughout the process to accurately record the clinical performance of the test valve in a near-human environment, providing a true and reliable basis for evaluating the service life of the mitral / tricuspid valve.

[0113] Based on the above-described preferred embodiments of the present invention, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the inventive concept. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A real-time wear testing device for mitral or tricuspid valves used in cardiovascular implants, characterized in that, Includes multiple test facilities arranged side by side, wherein the test facilities include First compliance adjustment module (1); The second compliance adjustment module (2) is connected to the first compliance adjustment module (1) by a valve carrier module (5) and a reflux tube (6). A liquid flow pipe (3) is connected at one end to the first compliance adjustment module (1); The drive module (4), which is connected to the other end of the liquid flow pipe (3), is used to provide power for the test liquid in the test mechanism; The test liquid flows sequentially through the liquid flow pipe (3), the first compliance adjustment module (1), the return pipe (6), the second compliance adjustment module (2) and the valve carrier module (5), and then flows back into the first compliance adjustment module (1) and the liquid flow pipe (3) to perform a cyclic reciprocating motion; The first compliance adjustment module (1) includes a first adjustment box (1-1) that is connected to the valve carrier module (5), the reflux tube (6) and the liquid flow pipe (3) respectively. A one-way valve (1-6) is installed in the inner cavity of the first regulating box (1-1) for connecting the valve carrier module (5) and the return pipe (6). The second compliance adjustment module (2) includes a second adjustment box (2-1) that is connected to the valve carrier module (5) and the reflux tube (6) respectively; The bottom of the second adjustment box (2-1) is provided with a damping adjustment component; The top of the second regulating box (2-1) is provided with a liquid storage chamber (2-10) that communicates with its interior. A throttle valve (2-12) and a second rectifier valve plate (2-13) are installed in the inner cavity of the second regulating box (2-1) for connecting the valve carrier module (5) and the return pipe (6); The liquid flow channel (3) is located below the valve carrier module (5).

2. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, A first rectifier valve plate (1-12) is provided on the lower side of the one-way valve (1-6). The top of the first regulating box (1-1) is provided with a first exhaust switch (1-7). The bottom of the first regulating box (1-1) is provided with a drain outlet (1-8). The first adjustment box (1-1) is provided with a first observation window (1-9) corresponding to the valve carrier module (5) on the side opposite to the valve carrier module (5). The first regulating box (1-1) is provided with a second observation window (1-10) on the side opposite to the return pipe (6) and corresponding to the return pipe (6).

3. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, The damping adjustment assembly includes an energy cavity (2-4) disposed at the bottom of the second adjustment box (2-1), a diaphragm (2-5) disposed between the second adjustment box (2-1) and the energy cavity (2-4), and a spring (2-6) disposed below the diaphragm (2-5). A second exhaust switch (2-11) is provided on the liquid storage chamber (2-10).

4. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, The valve carrier module (5) includes an outflow clamp (5-1) connected to the first compliance adjustment module (1), an inflow clamp (5-2) connected to the second compliance adjustment module (2), and a valve carrier (5-3) installed between the outflow clamp (5-1) and the inflow clamp (5-2), with the cardiovascular implant placed inside the valve carrier (5-3); Pressure sensors (5-5) are respectively installed on the outflow clamp (5-1) and the inflow clamp (5-2).

5. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, The reflux tube (6) is positioned above the valve carrier module (5), and a reflux throttle valve (6-1) is installed on the reflux tube (6).

6. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, The liquid flow pipe (3) includes a first flow pipe (3-1) connected to the drive module (4) and a second flow pipe (3-2) telescopically disposed at the free end of the first flow pipe (3-1) and connected to the first compliance adjustment module (1).

7. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, The drive module (4) includes a drive component, a sliding sleeve (4-2) installed at the power output end of the drive component, and a pusher (4-3) located inside the sliding sleeve (4-2) and connected to the power output rod of the drive component. The inner cavity of the sliding sleeve (4-2) away from the pusher (4-3) is connected to the liquid flow pipe (3). The driving component is a voice coil motor (4-1) or a cylinder.

8. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 1, characterized in that, Each test unit’s liquid flow pipe (3) is mounted on a main board (11), and the main board (11) is provided with a first through hole (11-1) for connecting the corresponding liquid flow pipe (3) with the drive module (4). A heating plate (12) is provided on the side of the motherboard (11) facing the drive module (4).

9. The real-time wear testing device for mitral or tricuspid valves in cardiovascular implants according to claim 8, characterized in that, The drive module (4) is provided with a connecting sleeve (4-5) on the side facing the motherboard (11) that communicates with the corresponding liquid flow pipe (3). The top of the connecting sleeve (4-5) is provided with an exhaust hole (4-6). A lower exhaust connector (4-7) is installed on the exhaust hole (4-6). The top of the motherboard (11) is provided with an exhaust chamber (11-2). An upper exhaust connector (11-3) is installed on the side of the exhaust chamber (11-2). The lower exhaust connector (4-7) and the upper exhaust connector (11-3) are connected through an air pipe. A third exhaust switch (11-4) is provided on the top of the exhaust chamber (11-2).

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