Flow field testing system for heart valve devices and flow field testing method

Abstract

A flow field test system and a flow field test method of a heart valve device, the flow field test system comprises a ventricle simulation module having a ventricle cavity formed by a plurality of side walls, the plurality of side walls comprising a first side wall and a second side wall opposite in a horizontal direction, a first diaphragm and a second diaphragm being respectively arranged on the first side wall and the second side wall and being flexible, the first diaphragm and the second diaphragm being separated by a rigid structure, the ventricle simulation module further comprising a driving part, the driving part applying pressure to the first diaphragm and the second diaphragm respectively, and driving the first diaphragm and the second diaphragm to deform towards or away from the ventricle cavity simultaneously to simulate the contraction or relaxation of the ventricle, the flow field test method being configured to cause the driving part to apply different pressures to the first diaphragm and the second diaphragm.

Description

Technical Field

[0001] This invention relates to a flow field testing system for cardiac valve devices and a flow field testing method using the same system. Background Technology

[0002] Heart valves are structures in the heart that ensure unidirectional and smooth blood flow. This unidirectional and smooth flow of blood through the valves is crucial for maintaining normal blood circulation. Therefore, for artificial heart valve devices that replace the body's natural heart valves, flow field testing—which measures the flow pattern of blood through the device—is a core method for evaluating the design rationale, hydrodynamic performance, and clinical safety of these devices in vitro.

[0003] Currently, in the flow field testing of heart valve devices, the heart valve device to be tested is placed at the corresponding position in the structural model of the heart, and a pressure difference is generated in the simulated ventricle to make the test fluid flow through the heart valve device. The flow field before and after flowing through the heart valve device is observed. In other words, the performance of the heart valve device is evaluated by the upstream and downstream flow fields of the heart valve device.

[0004] Previously, ventricular cavities used to simulate the heart were constructed from a single piece of flexible material. The expansion and contraction of this flexible material simulated the overall diastole and contraction of the ventricle. However, when deformed, these cavities, especially in relatively weaker areas, exhibit abnormal localized deformations, including over-expansion and wrinkling. This affects fluid flow patterns, making it difficult to achieve highly repeatable, physiologically similar deformations. This reduces clinical reference value and ultimately leads to poor reliability of flow field test results, severely limiting experimental flexibility and repeatability. More importantly, under physiological conditions, the ventricle does not contract and relax at the same amplitude as a whole. Specifically, the interventricular septum between the left and right ventricles and the free walls of the left and right ventricles exhibit significant differences in motion amplitude. Therefore, the actual blood flow pattern is more complex, causing in vitro flow field test results to sometimes fail to accurately reflect the performance of heart valve devices in the body. In severe cases, implanted heart valve devices can cause abnormal flow fields, further leading to hemolysis or thrombosis, posing a threat to life.

[0005] Therefore, there is an urgent need to design a new flow field testing system and method for heart valve devices to improve the reliability of test results of fluid flow field passing through heart valve devices in vitro. Summary of the Invention

[0006] The present invention was made in view of the above-mentioned problems, and its purpose is to provide a flow field testing system and method for heart valve devices, which can improve the reliability of the test results of the fluid flow field passing through the heart valve device in vitro.

[0007] To achieve the above objectives, the present invention provides a flow field testing system for heart valve devices, comprising: a ventricular simulation module having a ventricular cavity; an atrial simulation module having an atrial cavity; and an arterial simulation module having an arterial cavity. A valve mounting portion for mounting a heart valve device is respectively provided between the ventricular cavity and the atrial cavity, and between the ventricular cavity and the arterial cavity, and is connected via the valve mounting portion. The ventricular cavity is formed by a plurality of sidewalls, including a first sidewall and a second sidewall opposing each other in a horizontal direction. A flexible deformable first diaphragm and a second diaphragm are respectively provided on the first sidewall and the second sidewall. The first diaphragm and the second diaphragm are separated by a rigid structure. The ventricular simulation module further includes a driving portion, which applies pressure to the first diaphragm and the second diaphragm respectively, driving the first diaphragm and the second diaphragm to deform simultaneously toward or away from the ventricular cavity to simulate ventricular contraction or relaxation.

[0008] According to the flow field testing system for heart valve devices of the present invention, the first and second diaphragms, which are flexibly deformable, are separated by a rigid structure, and the driving part applies pressure to the first and second diaphragms respectively to simulate the contraction and relaxation of the ventricle through the deformation of the first and second diaphragms. Therefore, the deformation of one of the first and second diaphragms will not affect the other, and highly repeatable deformation can be achieved, thereby achieving highly repeatable simulation of ventricular contraction and relaxation, and improving the reliability of the flow field test results of heart valve devices.

[0009] Furthermore, in the flow field testing system for the heart valve device of the present invention, preferably, the drive unit includes: a first piston cylinder composed of a first cylinder and a first piston; a second piston cylinder composed of a second cylinder and a second piston; and a drive device for driving the first piston and the second piston to move, wherein the first diaphragm and the second diaphragm respectively separate the first cylinder and the second cylinder from the ventricular cavity, and liquid is filled between the first piston and the first diaphragm and the second piston and the second diaphragm, and the drive device is capable of adjusting the amount of movement of the first piston and the second piston.

[0010] The flow field testing system based on the above structure applies pressure to the diaphragm using liquid in the piston cylinder, and the movement of the piston can be adjusted by the drive device, thereby enabling controllable adjustment of the pressure applied to the diaphragm. In repeated tests simulating ventricular contraction and relaxation, the repeatability of the diaphragm deformation amplitude can be guaranteed, further improving the reliability of the flow field test results of the heart valve device.

[0011] Furthermore, in the flow field testing system for the heart valve device of the present invention, it is preferred that the flow area of ​​the liquid in the first cylinder and the second cylinder is the same, and the driving device is configured such that the amount of movement of the first piston is different from the amount of movement of the second piston.

[0012] According to the flow field testing system described above, the volume change between the piston and the diaphragm varies as the piston moves, resulting in different pressures applied to the first and second diaphragms, thus simulating the differential motion between the interventricular septum and the free wall of the ventricle. Therefore, by independently controlling the movement of the two pistons, flexible adjustment of the degree of asymmetric contraction is achieved, making it suitable for exploratory studies that need to simulate various pathological states.

[0013] Furthermore, in the flow field testing system for the heart valve device of the present invention, it is preferable that the driving device is configured to change the moving speed of the first piston and the second piston in a manner that first increases and then decreases.

[0014] According to the flow field testing system with the above structure, the piston does not move at a fixed speed but moves in a fast-then-slow manner. As a result, the deformation speed of the first and second diaphragms is also fast at first and then slow. This can better restore the action state of the interventricular septum and free wall during the contraction and relaxation process of the ventricle, and further improve the reliability of the flow field test results of the heart valve device.

[0015] Furthermore, in the flow field testing system for the heart valve device of the present invention, preferably, the flow areas of the liquid in the first cylinder and the second cylinder are the same, and the driving device is configured such that the movement of the first piston and the movement of the second piston are the same. The driving unit further includes a first rectifier and a second rectifier, the first rectifier and the second rectifier having different flow resistances to the liquid. The first rectifier is disposed in the first cylinder between the first piston and the first diaphragm, and the second rectifier is disposed in the second cylinder between the second piston and the second diaphragm. The driving unit further includes a liquid flow channel, the liquid flow channel enabling the liquid between the first rectifier and the first piston, and between the second rectifier and the second piston, to communicate with each other. When the driving device drives the first piston and the second piston to move, the liquid flows from one of the first cylinder and the second cylinder to the other through the liquid flow channel.

[0016] According to the flow field testing system described above, the different changes in liquid volume between the piston and the diaphragm during piston movement result in different pressures applied to the first and second diaphragms, thus simulating the differentiated motion phenomena of the interventricular septum and free wall of the ventricle. Therefore, through the liquid distribution mechanism that connects the rectifier to the liquid, dynamic regulation of asymmetric ventricular contraction can be achieved under a single drive source, enabling it to simulate ventricular compensatory function and making it suitable for research scenarios requiring a high degree of physiological functional replication.

[0017] Furthermore, in the flow field testing system for the heart valve device of the present invention, it is preferred that the flow resistance of the first rectifier and the second rectifier to the liquid is adjustable.

[0018] The flow field testing system based on the above structure can adjust the pressure applied to the diaphragm to the desired pressure value by adjusting the resistance of the rectifier, and can be easily adjusted according to the required deformation range of the diaphragm to meet the testing requirements.

[0019] Furthermore, in the flow field testing system for the heart valve device of the present invention, it is preferable that the driving device is configured such that the amount of movement of the first piston is the same as the amount of movement of the second piston, and the flow areas of the liquid in the first cylinder and the second cylinder are different.

[0020] According to the flow field testing system described above, the volume change between the piston and the diaphragm varies as the piston moves, resulting in different pressures applied to the first and second diaphragms. This simulates the differentiated movement of the interventricular septum and free wall of the ventricle. Therefore, by maintaining a fixed difference in the fluid flow area, highly repeatable and low-cost asymmetric contraction is achieved, making it suitable for standardized, high-volume valve performance testing scenarios.

[0021] Furthermore, in the flow field testing system for the heart valve device of the present invention, preferably, the flow field testing system for the heart valve device further includes a flow field observation module, which performs flow field testing through optical observation, wherein a portion of the rigid structure constitutes an observation window for optical observation, and the observation window is formed in the shape of a flat plate.

[0022] The flow field testing system based on the above structure uses a rigid planar structure for the optical observation window. When studying the flow field inside the ventricular cavity, there is no need for complex refractive index matching. This avoids the nonlinear optical distortion caused by light passing through the surface of a medium with inconsistent refractive indices, thereby eliminating the observation error caused by it. This improves the reliability of the flow field test results of the heart valve device and reduces the test cost and operation difficulty.

[0023] Furthermore, in the flow field testing system for the cardiac valve device of the present invention, preferably, the flow field observation module includes: a laser generator configured to emit a laser toward the ventricular cavity, the atrial cavity, and the arterial cavity; and a light absorber that absorbs stray light generated by the laser, the light absorber being disposed on the side opposite to the observation window relative to the ventricular cavity, the atrial cavity, and the arterial cavity.

[0024] The flow field testing system based on the above structure can absorb stray light using light-absorbing components, thereby improving the digital image signal-to-noise ratio of the observed images, reducing the complexity of post-processing algorithms, and improving the reliability of flow field test results for heart valve devices.

[0025] The present invention also provides a flow field testing method for a heart valve device. The flow field testing method of the aforementioned heart valve device flow field testing system applies different pressures to the first diaphragm and the second diaphragm by the driving part during the simulated ventricular contraction or relaxation process, so that the deformation amplitudes of the first diaphragm and the second diaphragm are different.

[0026] The flow field testing method for heart valve devices according to the present invention can simulate the differential motion phenomenon between the interventricular septum and the free wall of the ventricle, further improving the reliability of the flow field testing results of heart valve devices. Attached Figure Description

[0027] Figure 1 This is a cross-sectional view showing the structure of the test system according to the first embodiment.

[0028] Figure 2 This is a perspective view showing the structure of the test system according to the first embodiment.

[0029] Figure 3 This is a cross-sectional view showing the structure of the test system according to the second embodiment.

[0030] Figure 4 This is a perspective view showing the structure of the rectifier in the test system of the second embodiment.

[0031] Figure 5 This is a diagram illustrating the liquid flow pattern in the test system of the second embodiment.

[0032] Figure 6 This is a cross-sectional view showing the structure of the test system according to the third embodiment.

[0033] (Symbol Explanation)

[0034] 1000, 2000, 3000 Test System; 1100, 2100, 3100 Ventricular Module; 1110 Main Body; 1120 Ventricular Chamber; 1121, 2121, 3121 Ventricular Chamber; 1122 Left Side Wall; 1123 Right Side Wall; 1124 Anterior Side Wall; 1125, 2125, 3125 Diaphragm; 1130 Drive Unit; 1131, 2131 Cylinder; 3131a Left Cylinder; 3131b Right Cylinder; 1132, 2132, 3132 Piston; 1132a Piston Head; 1132b Piston Rod; 1133, 2133 Rectifier; 2133a Upper Grid; 2133b Lower Grid; 1140 Atrial Module Mounting Unit; 1141 Ventricular inflow tract; 1150 Artery module mounting section; 1151 Ventricular outflow tract; 1200, 2200, 3200 Atrial modules; 1210 Atrial cavity; 1211 Atrial cavity; 1212 Atrioventricular valve mounting section; 1220 Simulated blood vessel; 1300, 2300, 3300 Artery modules; 1310 Artery tube; 1311 Artery lumen; 1312 Semilunar valve mounting section; Light-absorbing component 1400; 2134, 3134 Piston connection section; 2135 Piston internal flow channel; 2136 Liquid injection port; 2137 Exhaust port; 3133 Filling flow channel. Detailed Implementation

[0035] (First Implementation)

[0036] Below, in conjunction with Figure 1 as well as Figure 2 The flow field testing system for a heart valve device according to the first embodiment of the present invention (hereinafter referred to as "test system 1000") will be described.

[0037] The test system 1000 of this embodiment is used to detect the flow field at the implantation site of an artificial heart valve device in vitro. The heart valve device mentioned here includes valve repair devices and valve replacement devices. Specifically, it can be any one of the following: the mitral valve between the left atrium and the left ventricle, the tricuspid valve between the right atrium and the right ventricle, the aortic valve between the left ventricle and the aorta, and the pulmonary valve between the right ventricle and the pulmonary artery.

[0038] like Figure 1 as well as Figure 2 As shown, the test system 1000 of this embodiment includes three modules: a ventricular module 1100 for simulating the left or right ventricle, an atrial module 1200 for simulating the left or right atrium, and an arterial module 1300 for simulating the aorta or pulmonary artery. Furthermore, although not shown, the test system 1000 of this embodiment also includes a flow field observation module for detecting the flow field in the above three modules.

[0039] For ease of explanation, the following references are provided. Figure 2 The coordinate axes marked in the figure illustrate the orientation of each structure. The orientations are determined based on the settings of the test system 1000. Specifically, the up-down direction is the direction of the plumb bob, the left-right direction is the horizontal direction orthogonal to the direction of the plumb bob, and the front-back direction is the direction orthogonal to both the up-down and left-right directions.

[0040] like Figure 1 as well as Figure 2 As shown, the ventricular module 1100 includes a main body 1110 and a ventricular cavity 1120, a drive unit 1130, an atrial module mounting unit 1140, and an arterial module mounting unit 1150 disposed on the main body 1110.

[0041] The main body 1110 constitutes the main body of the ventricular module 1100, and its overall shape is roughly rectangular.

[0042] The ventricular cavity 1120 is the part of the ventricular module 1100 used to simulate the structure of the left or right ventricle. The ventricular cavity 1120 is formed in the center of the main body 1110 along its length, forming a hollow ventricular cavity 1121 within the main body 1110 and opening upward. The ventricular cavity 1120 includes a left side wall 1122, a right side wall 1123, an anterior side wall 1124, and a posterior side wall (not shown) for surrounding the ventricular cavity 1121.

[0043] The left side wall 1122 and the right side wall 1123 are located near the center in the left-right direction on the main body 1110 and are arranged opposite each other in the left-right direction. Specifically, the left side wall 1122 and the right side wall 1123 extend downward in an arc shape from a position near the artery module 1300 and the atrial module 1200, and join at the lower end. When viewed in the front-back direction, the left side wall 1122 and the right side wall 1123 form a symmetrical shape. In addition, the left side wall 1122 and the right side wall 1123 are respectively connected to the cylinder 1131 (described later) on the outer side of the ventricular cavity 1121.

[0044] It should be noted that when the ventricular cavity 1120 is used to simulate the left ventricle, the left side wall 1122 corresponds to the interventricular septum in the left ventricle of the human heart, and the right side wall 1123 corresponds to the free wall in the left ventricle. Conversely, when the ventricular cavity 1120 is used to simulate the right ventricle, the left side wall 1122 corresponds to the free wall in the right ventricle, and the right side wall 1123 corresponds to the interventricular septum in the right ventricle.

[0045] The front sidewall 1124 and the rear sidewall are respectively disposed near the front end face and the rear end face of the main body 1110, and are sealed to the left sidewall 1122 and the right sidewall 1123 by fitting their outer periphery against the inner periphery of the left sidewall 1122 and the right sidewall 1123. At this time, the upper ends of the front sidewall 1124, the rear sidewall, the left sidewall 1122, and the right sidewall 1123 are at the same position in the vertical direction, that is, their upper ends are flush. The front sidewall 1124 and the rear sidewall have the same shape. Specifically, in this embodiment, when viewed in the front-back direction, the front sidewall 1124 and the rear sidewall are roughly in the shape of half an ellipse divided along the minor axis of an ellipse. However, the shape of the front sidewall 1124 and the rear sidewall (as well as the left sidewall 1122 and the right sidewall 1123) is not limited to this, and can be any shape suitable for simulating the ventricles of the human heart.

[0046] Furthermore, the left side wall 1122, right side wall 1123, front side wall 1124, and rear side wall are made of rigid materials. In this embodiment, the front side wall 1124 is made of a flat plate of a material with good visible light transmittance, such as glass or acrylic, to serve as an observation window for observing the fluid flow field within the ventricular cavity 1121. The left side wall 1122, right side wall 1123, and rear side wall are preferably made of the same material as the front side wall 1124 and rear side wall, such as glass or acrylic, which has good visible light transmittance. Additionally, each side wall is preferably made of the same material to facilitate joining the side walls together.

[0047] The drive unit 1130 is used to deform the diaphragm 1125 of the ventricular cavity 1120 to simulate the contraction and relaxation of the ventricles of the human heart. In this embodiment, the drive unit 1130 includes a cylinder 1131, a piston 1132, and a motor (not shown).

[0048] The cylinder barrel 1131 is integrally formed into a cylindrical tubular structure. In this embodiment, it includes two cylinder barrels 1131 with the same inner diameter. Furthermore, Figure 1 The illustration only shows the portion of cylinder 1131 within the main body 1110. It should be understood that cylinder 1131 may also include a portion extending further in a tubular shape outside the main body 1110. Two cylinders 1131 are respectively disposed on both sides of the main body 1110 relative to the ventricular cavity 1120 in the left-right direction, with their axes aligned along the left-right axis. One axial end of cylinder 1131 is connected to either the left side wall 1122 or the right side wall 1123 of the ventricular cavity 1120, and the interior of cylinder 1131 is sealed and separated from the ventricular cavity 1121 by a diaphragm 1125. The other axial end of cylinder 1131 is open to allow piston 1132 to enter.

[0049] Here, the diaphragm 1125 is made of a flexible material that can deform flexibly under pressure to simulate the contraction and relaxation of the interventricular septum or free wall of the ventricles in the human heart. Furthermore, the diaphragm 1125 is preferably made of a material with good visible light transmittance, such as polydimethylsiloxane.

[0050] Two pistons 1132 are provided corresponding to the cylinder 1131, and each piston has a piston head 1132a and a piston rod 1132b. The piston head 1132a can be inserted into the cylinder 1131 through an opening on the end face of the main body 1110 in the left-right direction, and can move linearly relative to the cylinder 1131 in the left-right direction in a manner in which its outer periphery seals the inner periphery of the cylinder 1131.

[0051] One end of the piston rod 1132b of the two pistons 1132 is connected to the piston head 1132a, and the other end is connected to the output shafts of two independent motors. Here, the motors are motors that convert electrical energy into linear motion mechanical energy of the output shaft, such as linear motors. The output shafts of the motors drive the piston head 1132a to move linearly in the left-right direction within the cylinder 1131 via the piston rod 1132b.

[0052] Thus, a piston cylinder structure is formed by cylinder 1131 and piston 1132. When cylinder 1131 is filled with liquid, the piston 1132 is driven by a motor to move closer to or away from diaphragm 1125, applying pressure to diaphragm 1125 toward or away from the ventricular cavity 1121, causing diaphragm 1125 to deform flexibly, thereby simulating the process of ventricular contraction or relaxation. The specific details of controlling the movement of piston 1132 to simulate ventricular contraction and relaxation will be described in detail later.

[0053] Furthermore, the liquid filled inside the cylinder 1131 is preferably an incompressible fluid such as water.

[0054] In addition, Figure 1 as well as Figure 2 In the illustrated case, the two pistons 1132 are respectively positioned on the left and right sides of the ventricular cavity 1121 within the cylinders 1131 on the left and right sides. However, the orientation of the pistons 1132 relative to the ventricular cavity 1121 can be specifically selected based on factors such as the layout of the test site, and is preferably positioned in a location that will not interfere with image acquisition within the ventricular cavity 1121. For example, they can also be positioned on the upper and lower sides relative to the ventricular cavity 1121, one can be positioned on one side in the upper and lower direction and the other on one side in the left and right direction, or they can be positioned on the same side in both the upper and lower and left and right directions.

[0055] In addition, a flow rectifier 1133 can be provided inside the cylinder 1131. The flow rectifier 1133 is used to rectify the flow of liquid inside the cylinder 1131. In this embodiment, two flow rectifiers 1133 are provided corresponding to the two cylinders 1131, such as... Figure 1 As shown, the rectifier 1133 is formed as a plate with multiple rectifier holes extending along the thickness direction. It is disposed within the cylinder 1131 between the piston 1132 and the diaphragm 1125 in a left-right direction along the thickness direction, and is positioned close to the diaphragm 1125 relative to the piston 1132. When viewed in the left-right direction, the multiple rectifier holes are densely arranged at equal intervals. When the flow passes through these rectifier holes, it constrains and guides the flow, and generates equal resistance.

[0056] Therefore, when driving piston 1132 to move, the large-scale vortex between piston 1132 and rectifier 1133 becomes a small-scale, low-disturbance, straight flow in the left-right direction after flowing through rectifier 1133, forming a flow with uniform velocity and pressure distribution. This ensures uniform pressure distribution applied to diaphragm 1125, prevents irregular deformation of diaphragm 1125, and improves the simulation effect of ventricular contraction and relaxation in the human heart. However, rectifier 1133 can be omitted if the stability of the liquid flow can be guaranteed.

[0057] The atrial module mounting part 1140 is used for mounting the atrial module 1200 to the ventricular module 1100. It is formed on the main body 1110 above the ventricular cavity 1120. In this embodiment, when viewed from the front, the atrial module mounting part 1140 protrudes from the upper right end of the ventricular cavity 1120 and has a mounting surface that slopes downward to the right at the upper end. The atrial module 1200 is mounted to the ventricular module 1100 by sealing connection with this mounting surface.

[0058] In addition, a ventricular inflow channel 1141 is provided on the atrial module mounting part 1140. The ventricular inflow channel 1141 passes through the atrial module mounting part 1140 and communicates with the ventricular cavity 1121 at one end (the lower end), and can communicate with the atrial cavity 1210 in the atrial module 1200 described later at the other end.

[0059] The arterial module mounting portion 1150 is used for mounting the arterial module 1300 to the ventricular module 1100. It is formed on the main body portion 1110 above the ventricular cavity 1120 and is preferably arranged adjacent to the atrial module mounting portion 1140 in the left-right direction. In this embodiment, when viewed from the front, the atrial module mounting portion 1140 protrudes from the upper end of the ventricular cavity 1120 to the upper left and has a mounting surface that slopes downward to the left at the upper end. The arterial module 1300 is mounted to the ventricular module 1100 by sealingly connecting with this mounting surface.

[0060] In addition, a ventricular outflow channel 1151 is provided on the arterial module mounting part 1150. The ventricular outflow channel 1151 passes through the arterial module mounting part 1150 and communicates with the ventricular cavity 1121 at one end (the lower end), and can communicate with the arterial tube 1310 in the arterial module 1300 described later at the other end.

[0061] like Figure 1 as well as Figure 2 As shown, the atrial module 1200 in this embodiment includes an atrial cavity 1210 and a simulated blood vessel 1220.

[0062] In this embodiment, the atrial cavity 1210 is a regular octagonal box shape, with one end face (e.g., along its axial direction) facing outwards. Figure 1 The lower end face of the atrioventricular module 1100 is sealed and connected to the mounting surface of the atrioventricular module mounting part 1140 in the ventricular module 1100, and is installed in the ventricular module 1100. An atrioventricular cavity 1211 and an atrioventricular valve mounting part 1212 are formed in the atrioventricular cavity 1210. The atrioventricular cavity 1211 is a hollow cavity used to imitate the left or right atrium in the human heart. In this embodiment, the atrioventricular cavity 1211 is formed into a hemispherical shape after the sphere is cut along the axis, and is open on one side of the cut surface. However, the shape of the atrioventricular cavity 1211 is not limited to this. It can also be formed into any shape suitable for the atrium of the human heart in the module, and preferably, it is designed into different suitable shapes depending on whether the left or right atrium is being imitated.

[0063] The atrioventricular valve mounting section 1212 is used to mount an artificial heart valve device with a mitral or tricuspid valve. It is located within the atrial cavity 1210, relative to the atrial cavity 1211, on the side where the atrial cavity 1210 and ventricular module 1100 are mounted. Furthermore, the atrioventricular valve mounting section 1212 communicates with the atrial cavity 1211, and when the atrial cavity 1210 is mounted to the ventricular module 1100, the atrioventricular valve mounting section 1212 communicates with the ventricular inflow tract 1141. Additionally, although... Figure 1 It is not shown in detail, but the atrioventricular valve mounting section 1212 has a structure for mounting different types of artificial mitral valves or tricuspid valves.

[0064] The simulated blood vessels 1220 are used to simulate blood vessels connected to the left or right atrium in the human body. Specifically, they simulate the four pulmonary veins connected to the left atrium or the superior vena cava and inferior vena cava connected to the right atrium. In this embodiment, four simulated blood vessels 1220 are provided. These four simulated blood vessels 1220 are respectively arranged on both sides of the atrial cavity 1210 in two mutually orthogonal directions. In other words, the four simulated blood vessels 1220 are arranged in a cross shape. Correspondingly, four through holes are formed in the atrial cavity 1210, extending from the outer peripheral surface to the inner peripheral surface and communicating with the atrial cavity 1211. Each simulated blood vessel 1220 is connected to the atrial cavity 1211 through the through holes.

[0065] like Figure 1 as well as Figure 2 As shown, the arterial module 1300 in this embodiment includes an arterial tube 1310, which is cylindrical in shape, with one end (e.g., along its axial direction) Figure 1 The lower end of the arterial module 11100 is sealed to the mounting surface of the arterial module mounting portion 1150 in the ventricular module 1100 and installed in the ventricular module 1100. The other end in the axial direction is connected to a storage container such as a tank (not shown). An arterial lumen 1311 and a semilunar valve mounting portion 1312 are provided within the arterial tube body 1310. The arterial lumen 1311 is used for the outflow of fluid from the ventricular cavity 1121, and the semilunar valve mounting portion 1312 is used for mounting aortic valve devices or pulmonary valve devices. It is located within the arterial tube body 1310 on the side near the arterial module mounting portion 1150. Furthermore, the semilunar valve mounting portion 1312 communicates with the arterial lumen 1311 within the arterial tube body 1310, and when the arterial tube body 1310 is installed in the ventricular module 1100, the semilunar valve mounting portion 1312 communicates with the ventricular outflow duct 1151. Additionally, although... Figure 1 It is not shown in detail, but the semilunar valve mounting section 1312 has a structure for mounting different types of artificial aortic valves or pulmonary valves.

[0066] In addition, the atrial cavity 1210 in the atrial module 1200 and the arterial tube 1310 in the arterial module 1300 are both made of materials with good visible light transmittance, such as transparent materials like glass and acrylic.

[0067] The flow field observation module utilizes so-called particle imaging testing technology to test and evaluate the flow field. It includes a laser generation unit, a camera unit, and an analysis unit. The laser generation unit, for example, includes a laser generator that can irradiate the atrial module 1200, ventricular module 1100, and arterial module 1300 from the front. As the fluid containing tracer particles flows through these modules, the tracer particles reflect or scatter light under laser irradiation, and this reflection is imaged by an image acquisition device. The camera unit, for example, includes a high-speed camera that can continuously capture multiple images at very short intervals from the front. The analysis unit, for example, is a computer including a memory and a processor, capable of storing the images captured by the camera unit in the memory and retrieving relevant programs from the memory to process and analyze the images, thereby analyzing the fluid flow field.

[0068] As an example of how the analysis unit analyzes the flow field, the analysis unit first preprocesses the images captured by the camera unit. This preprocessing includes background removal, noise reduction, etc., to highlight the tracer particles in the image as much as possible. It also calculates the flow velocity vector based on the two images and generates the velocity field of the fluid. It can also track the continuous motion of individual particles one by one and draw traces to observe flow conditions such as eddies and backflows.

[0069] Furthermore, the flow field observation module also includes a light-absorbing element 1400 for absorbing light. This element is located on the side opposite to the laser generating unit and the imaging unit in the front-to-back direction relative to the atrial module 1200, ventricular module 1100, and arterial module 1300. For example, when the laser generating unit and the imaging unit are in front of the aforementioned modules, the light-absorbing element 1400 is located behind them. In this embodiment, the light-absorbing element 1400 is formed in a flat plate shape. A light-absorbing slot is formed on the rear side of the main body 1110 of the ventricular module 1100 for inserting and mounting the light-absorbing element 1400. The light-absorbing element 1400 is inserted and fixed into the light-absorbing slot and positioned behind the aforementioned modules. However, the shape of the light-absorbing element 1400 is not limited to a flat plate; it can also be formed into a curved plate with a certain curvature. Furthermore, the fixing method of the light-absorbing element 1400 is not limited to this insertion into a slot; it can also be fixed to the main body 1110 by bolts or other fasteners, or by magnetic attraction or adhesion, or supported on one side of the main body 1110 by an independent bracket. Additionally, preferably, when viewed along the front-back direction, the ventricular cavity 1120 of the ventricular module 1100, the atrial cavity 1210 of the atrial module 1200, and the ventricular inflow duct 1141 therebetween fall within the range of the light-absorbing element 1400. A portion of the lower end of the arterial tube 1310 of the arterial module 1300 and the ventricular outflow duct 1151 between it and the ventricular cavity 1120 of the ventricular module 1100 also fall within the range of the light-absorbing element 1400.

[0070] Therefore, the stray light generated by the reflection or refraction of the laser when it passes through the above modules is absorbed by the light-absorbing component 1400, which reduces noise spots and improves the signal-to-noise ratio of the acquired image. In addition, it can also avoid the background light generated by the wall and other backgrounds, which would form a dark background in the captured image. The bright spots of the tracer particles have a large contrast with the background, making it easy to identify them from the image and reducing the difficulty and computation of image preprocessing.

[0071] The following describes an example of testing the upstream and downstream flow fields of a heart valve device using the test system 1000 of this embodiment.

[0072] In this example, with the atrial module 1200 simulating the left atrium and the ventricular module 1100 simulating the left ventricle, artificial mitral valve devices and aortic valve devices as cardiac valve devices are tested.

[0073] Before testing, the mitral valve device is correctly positioned in the atrioventricular valve mounting section 1212 of the atrial module 1200, and the aortic valve device is correctly positioned in the semilunar valve mounting section 1312 of the arterial module 1300. Then, the atrial module 1200 and the arterial module 1300 are sealed and installed into the ventricular module 1100. Furthermore, it is ensured that both cylinders 1131 are filled with a liquid such as purified water.

[0074] Next, a test solution is injected into the atrial module 1200 from the simulated blood vessel 1220. The test solution flows sequentially through the atrial cavity 1210, ventricular cavity 1121, and arterial cavity 1311 until the circulatory loop is filled with the test solution. This test solution is, for example, artificial blood that can well replicate the physical properties of blood and contains tracer particles of a suitable density. Furthermore, the refractive index of the components in the test solution can be adjusted to be the same as or similar to that of the visible light-transmitting materials in the atrial module 1200, ventricular module 1100, and arterial module 1300. Alternatively, materials with a refractive index the same as or similar to that of the predetermined test solution can be selected in the aforementioned modules.

[0075] Then, the control motor drives the pistons 1132 on both sides to move away from the diaphragm 1125. As the volume between the piston 1132 and the diaphragm 1125 in the cylinder 1131 increases, the pressure of the liquid between the diaphragm 1125 and the piston 1132 on the diaphragm 1125 decreases. Under the action of the pressure difference, the diaphragm 1125 expands outward relative to the ventricular cavity 1121. The volume of the ventricular cavity 1121 increases and forms a low-pressure cavity. The test solution in the atrial cavity 1210 is forced open by the pressure difference and flows into the ventricular cavity 1121, completing a simulation of a left ventricular diastolic process.

[0076] In simulating left ventricular diastole, to simulate the physiological phenomenon where the free wall of the left ventricle moves more than the interventricular septum during diastole, the movement of the pistons 1132 on both sides is controlled so that the expansion amplitude of the right diaphragm 1125 is greater than that of the left diaphragm 1125. Specifically, in this embodiment, when controlling the pistons 1132 on both sides to move away from the diaphragm 1125, the output of the motor can be controlled so that the moving distance of the right piston 1132 per unit time is greater than that of the left piston 1132. As a result, the increase in volume between the piston 1132 and the diaphragm 1125 in the right cylinder 1131 is greater, and the decrease in pressure of the liquid on the diaphragm 1125 is also greater. Therefore, the expansion amplitude of the right diaphragm 1125 under the pressure difference is greater than that of the left diaphragm 1125, which can more realistically simulate the diastole process of the left ventricle in the human heart.

[0077] Then, the control motor drives the pistons 1132 on both sides to move in a manner close to the ventricular cavity 1121. As the volume between the piston 1132 and the diaphragm 1125 in the cylinder 1131 decreases, the pressure of the liquid between the diaphragm 1125 and the piston 1132 on the diaphragm 1125 increases. Under the action of the pressure difference, the diaphragm 1125 retracts inward relative to the ventricular cavity 1121. The volume of the ventricular cavity 1121 decreases and forms a high-pressure cavity. The test solution in the atrial cavity 1210 is forced open by the pressure difference and flows into the arterial module 1300, completing the simulation of a left ventricular contraction process.

[0078] In simulating left ventricular contraction, to simulate the physiological phenomenon where the free wall of the left ventricle moves more than the interventricular septum during contraction, the movement of the pistons 1132 on both sides is controlled. The right piston 1132 moves a greater distance per unit time than the left piston 1132. This results in a greater decrease in volume between the piston 1132 and the diaphragm 1125 in the right cylinder 1131, leading to a greater increase in pressure on the diaphragm 1125. Consequently, the right diaphragm 1125 retracts more significantly than the left diaphragm 1125. This allows for a more realistic simulation of the left ventricular contraction process in the human heart.

[0079] Furthermore, in the simulated left ventricular diastole and systole process described above, in addition to controlling the amount of movement of the pistons 1132 on both sides, the movement speed of the pistons 1132 on both sides can also be controlled. Specifically, by controlling the output of the motor, the movement speed of the pistons 1132 on both sides is changed in a manner that first increases and then decreases during the movement. As a result, the deformation speed of the diaphragms 1125 on both sides can also be changed in a manner that first increases and then decreases, that is, the deformation action of the diaphragms 1125 is fast at first and then slows down, thereby better simulating the movement state of the interventricular septum and free wall during the diastole and systole of the left ventricle.

[0080] In addition, preferably, the variation range of the moving speed of the right piston 1132 is greater than that of the left piston 1132, for example, the peak value of the moving speed of the right piston 1132 is greater than that of the left piston 1132, thereby further restoring the difference in the action state of the interventricular septum and the free wall.

[0081] In the simulation of left ventricular diastole and systole described above, the flow field observation module was used to detect and analyze the upstream and downstream flow fields of the mitral valve and aortic valve devices, as explained earlier, to evaluate their performance. For example, the device performance can be evaluated based on the velocity field, shear stress field, and lag zone distribution adjacent to the heart valve device, combined with statistical analysis or Lagrange numerical calculations.

[0082] The above describes the use of the test system 1000 of this embodiment to simulate the left ventricle and test artificial mitral valve and aortic valve devices. It should be understood that when using the test system 1000 of this embodiment to simulate the right ventricle and test artificial tricuspid valve and pulmonary valve devices, the above description can be used. A tricuspid valve device can be installed in the atrial module 1200, a pulmonary valve device can be installed in the arterial module 1300, and then the atrial module 1200 and arterial module 1300 can be installed into the ventricular module 1100. The movement of the pistons 1132 on both sides can be appropriately controlled to simulate the diastole and systole of the right ventricle.

[0083] (Main effects of the first embodiment)

[0084] According to the test system 1000 of this embodiment, the ventricular cavity 1120 used to simulate the ventricle includes multiple sidewalls made of rigid material and diaphragms 1125 made of flexible material on the left side wall 1122 and the right side wall 1123. The diaphragms 1125 are retracted and expanded using a drive unit 1130 to simulate the contraction and relaxation of the ventricle. By controlling the movement of the piston 1132 in the drive unit 1130, different pressures are applied to the two diaphragms 1125, resulting in different retraction and expansion amplitudes of the two diaphragms 1125. This achieves independent control of the differentiated movement of the interventricular septum and the free wall, allowing for flexible adjustment of the deformation ratio on both sides according to experimental needs. This is suitable for exploratory research scenarios that require simulating various pathological states. Therefore, the process of blood flow driven by ventricular contraction and relaxation is simulated more realistically in vitro, enabling better testing and analysis of the upstream and downstream flow fields of the heart valve device in vitro. This improves the accuracy and reliability of in vitro evaluation of the heart valve device's performance and reduces the risk of the implanted heart valve device having lower-than-expected results.

[0085] Furthermore, given that nonlinear optical distortion is difficult to correct using conventional methods in engineering practice, the front sidewall 1124, serving as the observation window, is made of a rigid material in a flat plate shape. This avoids the nonlinear optical distortion caused when light passes through curved media with different refractive indices. When the front sidewall 1124 is flat, even if there is a difference in refractive index between the observation window and the test liquid, only linear optical distortion (or even no distortion in some areas) is likely to occur. Linear optical distortion does not substantially affect the flow field measurement results and can be precisely corrected by an affine transformation matrix if necessary. Thus, when studying the flow field within the ventricular cavity 1121, the observation error caused by nonlinear optical distortion is effectively eliminated, improving the reliability of the flow field test results for heart valve devices, while reducing experimental costs and operational difficulty.

[0086] Furthermore, the components of the testing system 1000 used to simulate the atria, ventricles, and arteries are modularly designed, allowing for flexible adjustment of the module combination based on the type of heart valve device to be tested, thus enabling simulation of the left atrium-left ventricle-aorta or the right atrium-right ventricle-pulmonary artery.

[0087] (Second Implementation)

[0088] The following, combined with Figures 3 to 5 The test system 2000 of the second embodiment of the present invention will be described.

[0089] like Figure 3As shown, the main difference between the test system 2000 of the second embodiment and the test system 1000 of the first embodiment lies in the structure of the drive unit in the ventricular module 2100. The other structures in the ventricular module 2100, as well as the structures of the atrial module 2200 and the arterial module 2300, are basically the same as in the first embodiment. Hereinafter, for structures in the test system 2000 of the second embodiment that are basically the same as those in the test system 1000 of the first embodiment, reference numerals obtained by adding 1000 to the corresponding reference numerals in the first embodiment will be used for labeling, and descriptions will be omitted.

[0090] like Figure 3 As shown, in the drive unit of the second embodiment, two cylinders 2131 with the same inner diameter are arranged with their axes aligned vertically. Two pistons 2132 are formed into cylindrical shapes and are respectively arranged with their axes aligned vertically. They move linearly in the vertical direction relative to the cylinders 2131 by sealing their outer peripheries with the inner circumferential surfaces of the cylinders 2131. The two pistons 2132 are connected by a piston connecting part 2134, which is connected to the output shaft of a linear motor. The linear motor drives the piston connecting part 2134 to move vertically, thereby causing the two pistons 2132 to move synchronously in the vertical direction.

[0091] Furthermore, piston internal flow channels 2135 are formed within the pistons 2132 and piston connection portion 2134. These internal flow channels 2135 open on the side of each piston 2132 near the diaphragm 2125, allowing the interiors of the two cylinders 2131 to communicate via the internal flow channels 2135. Additionally, the internal flow channels 2135 can partially extend to one end face of the pistons 2132 and open to form liquid injection ports 2136 for injecting liquid into the cylinders 2131. At this time, vent ports 2137, which allow only air to pass through but prevent liquid from passing through, can be provided on the cylinders 2131, facilitating the filling of the two cylinders 2131 from the liquid injection ports 2136 via the internal flow channels 2135. The liquid injection ports 2136 are blocked when the pistons 2132 are moved.

[0092] Furthermore, in this embodiment, the flow rectifiers 2133 in the two cylinders 2131 have different resistances to the liquid. More specifically, the flow rectifiers 2133 in the right cylinder 2131 have less resistance to the liquid flow than the flow rectifiers 2133 in the left cylinder 2131.

[0093] For example, rectifier 2133 can be Figure 4The adjustable flow rectifier 2133 shown has an upper grid disk 2133a and a lower grid disk 2133b that are stacked on top of each other and can rotate relative to each other. Multiple radially extending straight flow channels are formed on the upper grid disk 2133a and the lower grid disk 2133b, thus creating a grid structure on them. By rotating the lower grid disk 2133b relative to the upper grid disk 2133a, the phase difference of the grid structure on the upper grid disk 2133a and the lower grid disk 2133b changes, thereby adjusting the degree of overlap of the flow channels on the upper grid disk 2133a and the lower grid disk 2133b, and consequently adjusting the flow resistance of the flow rectifier 2133 to the liquid.

[0094] The aforementioned adjustment of the fluid resistance of the rectifier 2133 can be performed before the rectifier 2133 is placed inside the cylinder 2131, or the lower grid plate 2133b can be connected to the output shaft of the rotary motor, and after the rectifier 2133 is fixed to the inner circumferential surface of the cylinder 2131 by the upper grid plate 2133a, the lower grid plate 2133b can be rotated and adjusted by the rotary motor.

[0095] It should be understood that, Figure 4 The structure of the rectifier 2133 shown is only one example, and the structure of the rectifier 2133 is not limited to this. Figure 4 The structure shown. For example, the grid structure on the upper grid disk 2133a and the lower grid disk 2133b of the rectifier 2133 can also be fan-shaped, or it can be based on the structure of the rectifier 1133 in the first embodiment, with different resistances achieved by adjusting the aperture of the rectifier holes or the spacing and density of the rectifier hole arrangement.

[0096] The following describes an example of testing the upstream and downstream flow fields of a heart valve device using the test system 2000 of this embodiment.

[0097] In this example, the atrial module 2200 simulates the left atrium and the ventricular module 2100 simulates the left ventricle, and artificial mitral valve devices and aortic valve devices are tested as cardiac valve devices. Furthermore, the operations prior to simulating ventricular diastole and systole, as well as the operations for observing and analyzing the flow field, are basically the same as those described in the first embodiment, and therefore will not be repeated below.

[0098] When the control motor drives the pistons 2132 on both sides to move away from the diaphragm 2125, as described in the first embodiment above, the test solution in the atrial module 2200 flows into the ventricular cavity 2121 under the action of pressure difference, thus simulating a diastolic process of the left ventricle. At this time, the pistons 2132 on both sides move synchronously, and the volume change between the diaphragm 2125 and the pistons 2132 in the cylinders 2131 on both sides is the same. However, since the flow resistance of the rectifier 2133 in the left cylinder 2131 is greater than that in the right cylinder 2131, the liquid will flow as follows: Figure 5 As shown by the dashed arrow in (A), the liquid flows from the right cylinder 2131 to the left cylinder 2131. Thus, although the volume between the diaphragm 2125 and the piston 2132 in both cylinders 2131 is the same, the amount of liquid between the diaphragm 2125 and the piston 2132 in the left cylinder 2131 is increased. The decrease in pressure of the liquid on the diaphragm 2125 in the right cylinder 2131 is greater than the decrease in pressure of the liquid on the diaphragm 2125 in the left cylinder 2131.

[0099] Therefore, the expansion amplitude of the right diaphragm 2125 under pressure difference is greater than that of the left diaphragm 2125, which can more realistically simulate the diastolic process of the left ventricle in the human heart.

[0100] Then, the control motor drives the pistons 2132 on both sides to move close to the ventricular cavity 2121. As described in the first embodiment above, the test solution in the ventricular cavity 2121 is forced open by the pressure difference and flows into the arterial module 2300, completing a simulation of a left ventricular contraction process. At this time, the pistons 2132 on both sides move synchronously, and the volume change between the diaphragm 2125 and the piston 2132 in the cylinders 2131 on both sides is the same. However, since the flow resistance of the rectifier 2133 in the left cylinder 2131 is greater than that in the right cylinder 2131, the liquid will flow as follows: Figure 5 As shown by the dashed arrow in (B), the liquid flows from the left cylinder 2131 to the right cylinder 2131. Thus, although the volume between the diaphragm 2125 and the piston 2132 in both cylinders 2131 is the same, the amount of liquid between the diaphragm 2125 and the piston 2132 in the right cylinder 2131 is increased. The increase in pressure of the liquid on the diaphragm 2125 in the right cylinder 2131 is greater than the increase in pressure of the liquid on the diaphragm 2125 in the left cylinder 2131.

[0101] Therefore, the right diaphragm 2125 retracts more under pressure differential than the left diaphragm 2125, which can more realistically simulate the contraction process of the left ventricle in the human heart.

[0102] In addition, during the simulated diastole and systole of the left ventricle, similar to the first embodiment, the moving speed of the pistons 2132 on both sides can be controlled so that the moving speed of the pistons 2132 on both sides changes in a manner that first increases and then decreases during the movement.

[0103] The above describes the use of the test system 2000 of this embodiment to simulate the left ventricle and test artificial mitral valve devices and aortic valve devices. It should be understood that when using the test system 2000 of this embodiment to simulate the right ventricle and test artificial tricuspid valve devices and pulmonary valve devices, the above description can be used. A tricuspid valve device can be installed in the atrial module 2200, a pulmonary valve device can be installed in the arterial module 2300, and then the atrial module 2200 and arterial module 2300 can be installed into the ventricular module 2100. The resistance of the rectifier 2133 can be appropriately adjusted to simulate the diastole and systole of the right ventricle.

[0104] (Main effects of the second embodiment)

[0105] According to the test system 2000 of this embodiment, by connecting the liquids in the cylinders 2131 on both sides and setting rectifiers 2133 with different resistances, a pressure difference is created on the two diaphragms 2125, resulting in different contraction / relaxation amplitudes of the two diaphragms 2125. This design not only simulates the asymmetric movement of the interventricular septum and free wall in the human heart, but more importantly, by adjusting the resistance of the rectifiers 2133, the pressure ratio on both sides can be dynamically changed, thereby simulating the compensatory function of the ventricle under different pathological loads. This is suitable for application scenarios that require a high degree of reproduction of ventricular physiological function. For example, when the contractile capacity of the free wall decreases, the interventricular septum can be compensatorily enhanced by adjusting the resistance to maintain total stroke volume. Thus, the physiological process of ventricular contraction / relaxation driving blood is more realistically reproduced in vitro, enabling more accurate evaluation of the flow field characteristics upstream and downstream of the heart valve device. This significantly improves the clinical relevance and reliability of in vitro testing and reduces the risk of the device's performance falling short of expectations after implantation.

[0106] Furthermore, this embodiment requires only one motor to simulate ventricular diastole and systole, reducing equipment costs and simplifying the control process.

[0107] (Third Implementation)

[0108] The following, combined with Figure 6 The test system 3000 of the third embodiment of the present invention will be described.

[0109] like Figure 6As shown, the main difference between the test system 3000 of the third embodiment and the test system 2000 of the second embodiment lies in the different inner diameters of the cylinders on both sides. Specifically, the inner diameter of the left cylinder 3131a on the left side is smaller than that of the right cylinder 3131b on the right side. Furthermore, the piston internal flow channels connecting the two cylinders are not provided in the pistons 3132 and piston connecting portions 3134 on both sides. Additionally, flow straighteners with different resistances are no longer provided inside the cylinders. The remaining structure is basically the same as the test system in the second embodiment. Hereinafter, for structures in the test system 3000 of the third embodiment that are basically the same as those in the test system 2000 of the second embodiment, reference numerals obtained by adding 1000 to the corresponding reference numerals in the second embodiment will be used for labeling, and explanations will be omitted.

[0110] In addition, in this embodiment, filling channels 3133 for filling liquid into the cylinder can be formed on the two pistons 3132 respectively, and the inlet of the filling channel 3133 is blocked when the piston 3132 is moved.

[0111] The following describes an example of testing the upstream and downstream flow fields of a heart valve device using the test system 3000 of this embodiment.

[0112] In this example, the atrial module 3200 simulates the left atrium and the ventricular module 3100 simulates the left ventricle, and artificial mitral valve devices and aortic valve devices are tested. Furthermore, the operations prior to the ventricular diastolic and systolic simulation operations, as well as the flow field observation and analysis operations, are basically the same as those described in the first embodiment, and will not be repeated here.

[0113] When the control motor drives the pistons 3132 on both sides to move away from the diaphragm 3125, consistent with the description in the first embodiment, the test solution inside the atrial module 3200 is forced open by the pressure difference and flows into the ventricular cavity 3121, completing a simulation of a left ventricular diastolic process.

[0114] At this time, the pistons 3132 on both sides move synchronously. Since the inner diameter of the right cylinder 3131b is larger, i.e., the cross-sectional area is larger, the volume between the piston 3132 and the diaphragm 3125 inside the right cylinder 3131b increases more, and the pressure reduction of the liquid on the diaphragm 3125 is also greater. As a result, the expansion amplitude of the right diaphragm 3125 under the action of pressure difference is greater than that of the left diaphragm 3125, which can more closely simulate the diaphragm movement process of the left ventricle of the human heart.

[0115] Subsequently, the control motor drives the pistons 3132 on both sides to move closer to the ventricular cavity 3121. As described in the first embodiment above, the test solution inside the ventricular cavity 3121 is forced open by the pressure difference and flows into the arterial module 3300, completing a simulation of a left ventricular contraction process.

[0116] At this time, the pistons 3132 on both sides still move synchronously. Because the inner diameter of the right cylinder 3131b is larger, the volume reduction between the piston 3132 and the diaphragm 3125 in the right cylinder 3131b is greater, and the pressure increase of the liquid on the diaphragm 3125 is also greater. This makes the retraction amplitude of the right diaphragm 3125 under the action of pressure difference greater than that of the left diaphragm 3125, which can highly reproduce the contraction process of the left ventricle of the human heart.

[0117] In addition, during the simulated diastole and systole of the left ventricle, similar to the first embodiment, the moving speed of the pistons 3132 on both sides can be controlled so that the moving speed of the pistons 3132 on both sides changes in a manner that first increases and then decreases during the movement.

[0118] The above is a description of the simulation of the left ventricle and the flow field testing of artificial mitral valve devices and aortic valve devices using the test system 3000 of this embodiment. It is easy to understand that when using the test system 3000 of this embodiment to simulate the right ventricle and test artificial tricuspid valve devices and pulmonary valve devices, the above-described operation method can be followed. The tricuspid valve device is installed inside the atrial module 3200, and the pulmonary valve device is installed inside the arterial module 3300. Then, the atrial module 3200 and the arterial module 3300 are assembled into the ventricular module 3100. By adjusting the inner diameter ratio of the cylinders on both sides, the simulation of right ventricular diastolic and systolic movements can be completed.

[0119] (Main effects of the third embodiment)

[0120] According to the test system 3000 of this embodiment, by setting the cylinders on both sides to different inner diameters, the pressure acting on the diaphragms 3125 on both sides forms a fixed proportional difference, thereby achieving differentiated movements of the retraction and expansion amplitudes of the diaphragms 3125 on both sides. Compared with the first and second embodiments, this embodiment, without increasing the control difficulty (i.e., requiring only a single motor), makes the movement amplitudes of the interventricular septum and the free wall present a fixed proportional relationship, with higher motion repeatability, and is suitable for standardized experimental scenarios requiring high test consistency. This embodiment accurately reproduces the real motion state of the interventricular septum and the free wall in the ventricle of the human heart, and at the same time, only a single motor is required to complete the simulation of the entire process of ventricular diastole and systole, effectively reducing equipment construction costs and simplifying the overall control logic and operation process.

[0121] (Modified example)

[0122] In the first to third embodiments described above, the case where the cylinder is cylindrical was used as an example. However, the shape of the cylinder is not limited to this. For example, it can also be a square cylinder with rounded corners or various other shapes, and the shape of the piston used can be appropriately changed. The shapes of the cylinders on both sides can also be different from each other, and can be appropriately applied to the ventricular module in the above embodiments by having the same or different cross-sectional areas.

[0123] Furthermore, in the second embodiment described above, the case in which an internal flow channel 2135 connecting the two cylinders 2131 is formed between the two pistons 2132 was described as an example. However, the location of the flow channel connecting the two cylinders 2131 is not limited to this. It is sufficient that the flow channel is provided with an opening on the side closer to the piston 2132 relative to the flow straightener 2133 so that the liquid in the flow straighteners in the cylinders 2131 on both sides is connected to the piston.

[0124] It should be understood that within the scope of this invention, the various parts of the embodiments can be freely combined, or the various parts of the embodiments can be appropriately modified or omitted.

Claims

1. A flow field testing system for cardiac valve devices, comprising: A ventricular simulation module with ventricular chambers; An atrial simulation module with an atrial cavity; And an artery simulation module with an arterial lumen, wherein valve mounting portions for mounting heart valve devices are respectively provided between the ventricular cavity and the atrial cavity, and between the ventricular cavity and the arterial lumen, and are connected via the valve mounting portions, characterized in that, The ventricular cavity is formed by multiple sidewalls, including a first sidewall and a second sidewall that are horizontally opposite each other. A flexible and deformable first diaphragm and a second diaphragm are respectively disposed on the first sidewall and the second sidewall, and the first diaphragm and the second diaphragm are separated by a rigid structure. The ventricular simulation module also includes a drive unit. The drive unit includes: a first piston cylinder consisting of a first cylinder barrel and a first piston; a second piston cylinder consisting of a second cylinder barrel and a second piston; and a drive device for driving the first piston and the second piston to move. The first diaphragm and the second diaphragm respectively separate the first cylinder and the second cylinder from the ventricular cavity, and liquid is filled between the first piston and the first diaphragm, and between the second piston and the second diaphragm. The drive device can adjust the amount of movement of the first piston and the second piston. The flow area of ​​the liquid in the first cylinder and the second cylinder is the same. The drive device is configured such that the amount of movement of the first piston is different from the amount of movement of the second piston. The driving unit applies pressure to the first diaphragm and the second diaphragm respectively, driving the first diaphragm and the second diaphragm to deform simultaneously toward or away from the ventricular cavity, so as to simulate the contraction or relaxation of the ventricle.

2. The flow field testing system for heart valve devices as described in claim 1, characterized in that, The drive device is configured to change the moving speed of the first piston and the second piston in a manner that first increases and then decreases.

3. The flow field testing system for cardiac valve devices as described in claim 1 or 2, characterized in that, The flow field testing system for the heart valve device also includes a flow field observation module, which performs flow field testing through optical observation. A portion of the rigid structure forms an observation window for optical observation, and the observation window is formed in a flat plate shape.

4. The flow field testing system for heart valve devices as described in claim 3, characterized in that, The flow field observation module includes: a laser generator configured to emit laser light toward the ventricular cavity, the atrial cavity, and the arterial cavity; and a light absorber that absorbs stray light generated by the laser. The light-absorbing element is positioned on the opposite side of the observation window, relative to the ventricular cavity, the atrial cavity, and the arterial cavity.

5. A flow field testing method for a heart valve device, wherein the flow field testing method uses the flow field testing system for heart valve devices according to any one of claims 1 to 4, characterized in that, During the simulated contraction or relaxation of the ventricle, the driving part applies different pressures to the first diaphragm and the second diaphragm, so that the deformation amplitudes of the first diaphragm and the second diaphragm are different.

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