A testing system and method for artificial heart valve implants

Abstract

This application discloses a testing system and method for artificial heart valve implants, relating to the field of medical device testing technology. The system includes: a ventricular simulator, an atrial simulator, a highly transparent and compliant valve testing chamber containing an artificial heart valve, a vascular compliance simulator, and a vascular damping simulator forming a circulation loop, a high-speed camera, and a laser generator. The circulation loop simulates the blood flow environment of the artificial heart valve, with a tracer particle suspension added to the flow medium. The ventricular simulator, atrial simulator, vascular damper, and vascular compliance simulator provide power, storage space, resistance, and pulse pressure to the flow medium, respectively. The laser generator and high-speed camera work together to acquire particle images after implantation of the artificial heart valve. The particle images are uploaded to a computer for visual analysis of the heart valve pulsating flow field based on digital particle image velocimetry technology, thereby enabling quantitative analysis of the risk after implantation at the intended site.

Description

Technical Field

[0001] This application relates to the field of medical device testing technology, and in particular to a testing system and method for artificial heart valve implants. Background Technology

[0002] In 2002, Professor Alain G. Cribier of France successfully performed the world's first transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR). This technique involves inserting an interventional catheter through the femoral artery to deliver an artificial heart valve to the aortic valve area and deploy it, thus restoring valve function without open-chest surgery. This significantly reduces surgical trauma for patients and accelerates postoperative recovery.

[0003] For high-risk patients or those with contraindications to cardiac surgery, transcatheter aortic valve implantation (TAVI) can now be considered an effective treatment option. Recent studies have shown that for patients with severe, inoperable aortic stenosis, TAVI can reduce mortality by 46% compared to drug therapy and significantly improve patients' quality of life.

[0004] Artificial heart valves incorporate a variety of materials, including metallic stents and bioprosthetic leaflets, which may interact adversely with blood components after implantation. A deep understanding of these interactions can help predict potential thrombosis after device implantation, and quantitatively assessing the potential thrombosis and hemolysis risks of heart valve replacement surgery is an essential part of validating these device designs. This is due to the presence of multidimensional hemodynamic and biochemical processes, such as platelet activation / rupture, platelet deposition, and clot formation at the blood / material interface caused by high shear stress. Processes leading to blood damage include the presence of heart valve-related turbulence, such as blood flow stagnation and high shear stress.

[0005] Currently, the assessment of thrombosis and hemolysis binding in heart valve implants is mainly conducted through ex vivo blood evaluation or preclinical trials. While ex vivo blood evaluation can simulate the boundary conditions of the human body environment, such as temperature, pressure, and flow rate, the blood inevitably carries a risk of coagulation during contact with the device's inner wall, leading to inaccurate embolus detection data. Preclinical trials primarily involve releasing the implant into large animals and monitoring various blood parameters after implantation to preliminarily assess the thrombosis and hemolysis risks of the valve product. Because animal-derived and human blood vessels, pressure, and flow parameters differ, the test parameters can only serve as qualitative evaluations. Furthermore, large animal experiments are currently very costly, placing a significant economic burden on companies conducting related testing and research. Summary of the Invention

[0006] In view of this, the main objective of this application is to provide a testing system and method for artificial heart valve implants, with the aim of quantitatively analyzing the risk of thrombosis and potential hemolysis after implantation at the intended site of the heart valve.

[0007] The first aspect of this application provides a testing system for artificial heart valve implants, the system comprising: a ventricular simulator, an atrial simulator, a highly transparent and compliant valve testing chamber, a vascular compliance simulator, a vascular damping simulator, a high-speed camera, and a laser generator;

[0008] The ventricular simulator, atrial simulator, highly transparent compliant valve testing chamber, vascular compliance simulator, and vascular damping simulator are interconnected through pipes to form a circulation loop. An artificial heart valve implant is placed inside the highly transparent compliant valve testing chamber. During the test, the circulation loop simulates the blood flow environment of the artificial heart valve implant in the human body.

[0009] A ventricular simulator is used to power the flowing medium within a pipe; the flowing medium within the pipe contains a suspension of tracer particles.

[0010] An atrial simulator is used to store the flow medium within the tubing;

[0011] Vascular dampers are used to provide resistance to the flow of media within pipes;

[0012] A vascular compliance simulator is used to provide pulse pressure for the flowing medium within a pipeline;

[0013] A highly transparent and compliant valve testing cavity is used to provide an imaging window for high-speed cameras;

[0014] A laser generator is used to irradiate a highly transparent and compliant valve testing cavity with a laser.

[0015] A high-speed camera is used to acquire particle images of the implanted artificial heart valve after laser irradiation, and upload the particle images to a computer for visualization analysis of the heart valve pulsating flow field based on digital particle image velocimetry technology.

[0016] In some implementations of the first aspect of this application, the artificial heart valve implant is one of an artificial aortic valve, an artificial pulmonary valve, an artificial mitral valve, and an artificial tricuspid valve.

[0017] In some implementations of the first aspect of this application, when the artificial heart valve implant is an artificial aortic valve or an artificial pulmonary valve, the atrial simulator, the ventricular simulator, and the highly transparent compliant valve test chamber are connected in sequence in the circulatory loop.

[0018] In some implementations of the first aspect of this application, when the artificial heart valve implant is an artificial mitral valve or an artificial tricuspid valve, the atrial simulator, the highly transparent compliant valve test chamber, and the ventricular simulator are sequentially connected in the circulatory loop.

[0019] In some implementations of the first aspect of this application, the high-speed camera uses a two-frame mode to acquire particle images.

[0020] In some implementations of the first aspect of this application, the ventricular simulator specifically uses a high-power voice coil motor to regulate pressure and cardiac output, thereby providing power to the flowing medium within the pipeline.

[0021] In some implementations of the first aspect of this application, hollow glass beads are used as tracer particles in the tracer particle suspension.

[0022] A second aspect of this application provides a method for testing an artificial heart valve implant, the method comprising:

[0023] An artificial heart valve implant was placed inside a highly transparent compliance testing chamber, and the blood flow environment inside the human body was simulated within the highly transparent compliance testing chamber.

[0024] A laser is irradiated into the high transparency compliance test chamber, and the flowing medium inside the high transparency compliance test chamber contains a suspension of tracer particles;

[0025] Acquire particle images of the implanted artificial heart valve after laser irradiation, and generate an analytical view of the pulsatile flow field of the heart valve based on the particle images.

[0026] In some implementations of the second aspect of this application, the analysis view is a particle velocity field analysis view, wherein the particle velocity field analysis view is used to describe the particle velocity distribution in the normal plane of the heart valve axis at multiple systolic and diastolic moments within at least one cardiac cycle.

[0027] In some implementations of the second aspect of this application, the method further includes:

[0028] A particle shear stress field analysis view is generated based on the particle velocity distribution in the normal plane of the heart valve axis at multiple systolic and diastolic moments within at least one cardiac cycle. The particle shear stress field analysis view is used to describe the particle shear stress distribution in the normal plane of the heart valve axis at multiple systolic and diastolic moments within at least one cardiac cycle.

[0029] The technical solution provided in this application has the following beneficial effects: It constructs a testing system comprising a ventricular simulator, an atrial simulator, a highly transparent and compliant valve testing chamber, a vascular compliance simulator, a vascular damping simulator, a high-speed camera, and a laser generator. In this testing system, the ventricular simulator, atrial simulator, highly transparent and compliant valve testing chamber, vascular compliance simulator, and vascular damping simulator are interconnected via pipes to form a circulation loop. The highly transparent and compliant valve testing chamber contains an artificial heart valve implant. During testing, the circulation loop passes through the ventricular simulator, atrial simulator, and vascular... A damper, a vascular compliance simulator, and a highly transparent, compliant valve testing chamber simulate the blood flow environment of an artificial heart valve implant in the human body, thus providing accurate data support. The flow medium within the conduit contains a tracer particle suspension. A laser generator illuminates the highly transparent, compliant valve testing chamber to create a visualized flow field. A high-speed camera captures particle images of the implanted artificial heart valve after laser irradiation, and these images are uploaded to a computer for visual analysis of the heart valve pulsating flow field based on digital particle image velocimetry (DPV). Analyzing the particle images captured by the high-speed camera using DPV allows for the calculation of various parameters in the flow field, enabling quantitative analysis of the risk of thrombosis and potential hemolysis after implantation at the intended site. Attached Figure Description

[0030] Figure 1 A schematic diagram of the structure of a testing system for an artificial heart valve implant provided in an embodiment of this application;

[0031] Figure 2 This is a schematic diagram of a loop structure provided in an embodiment of this application;

[0032] Figure 3 This is a schematic diagram of another loop structure provided in an embodiment of this application;

[0033] Figure 4 This is a schematic diagram of the valve structure provided in an embodiment of this application;

[0034] Figure 5 This is a schematic diagram of particle images provided in the embodiments of this application;

[0035] Figure 6 A schematic diagram of a particle velocity field analysis view provided for an embodiment of this application;

[0036] Figure 7 A schematic diagram of a particle shear stress field analysis view provided for an embodiment of this application;

[0037] Figure 8 This is a flowchart illustrating a testing method for an artificial heart valve implant provided in an embodiment of this application. Detailed Implementation

[0038] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0039] See Figure 1 As shown, this application provides a testing system for artificial heart valve implants, which consists of a ventricular simulator 1, an atrial simulator 2, a highly transparent and compliant valve testing chamber 3, a vascular compliance simulator 4, a vascular damping simulator 5, a high-speed camera 6, and a laser generator 7.

[0040] In the system, the ventricular simulator 1, the atrial simulator 2, the highly transparent and compliant valve testing chamber 3, the vascular compliance simulator 4, and the vascular damping simulator 5 can be interconnected through pipes to form a closed-loop circulation circuit.

[0041] In the circulatory loop, the highly transparent and compliant valve testing chamber 3 serves as the core area, housing the artificial heart valve implant to be tested. The flow medium within the conduit flows in through the inlet of the highly transparent and compliant valve testing chamber 3 and exits through the artificial heart valve implant. This artificial heart valve implant refers to an artificial organ that can be implanted into the human heart to replace the original heart valve, allowing unidirectional blood flow and possessing the functions of a natural heart valve.

[0042] Meanwhile, to visualize the flow field, a suspension of tracer particles was added to the flowing medium inside the pipe. Furthermore, to ensure the realism of the simulated environment, the temperature of the flowing medium was controlled.

[0043] During testing, the flow of the medium within the circulation loop simulates the contraction and relaxation of the heart, as well as the compliance and damping characteristics of the vascular system, thus mimicking the flow of blood at the valves.

[0044] Specifically, ventricular simulator 1 acts as the power source, simulating the contraction and relaxation of the heart to drive the circulation of the fluid within the conduit. Atrial simulator 2 is responsible for storing and regulating the amount of fluid to simulate the blood storage function of the atria during the cardiac cycle.

[0045] The vascular damping simulator 5 simulates the blood flow resistance characteristics in a real vascular system by adjusting its internal structure or medium to provide the necessary resistance to the flowing medium; while the vascular compliance simulator 4 can simulate the expansion and contraction of blood vessels under different pressures, providing dynamic pulse pressure changes to the flowing medium and further improving the accuracy of the test.

[0046] The highly transparent and compliant valve test chamber 3 is made of highly transparent and compliant materials such as highly transparent silicone. It not only has high transparency, which makes it easy for the high-speed camera 6 to capture particle images during the opening and closing of the valve, but also has good compliance, which can more realistically simulate the interaction between the valve and the surrounding tissue.

[0047] Laser generator 7 emits a laser into the highly transparent and compliant valve test cavity 3 to illuminate the tracer particles, which are then captured by high-speed camera 6.

[0048] High-speed camera 6 captures particle images after laser irradiation at extremely high frame rates. These particle images record the smooth pulsation of the flow medium behind the artificial heart valve during its opening and closing. The high-speed camera 6 then uploads the captured particle images to a computer for further processing and analysis. Using image processing technology and fluid dynamics analysis software, researchers can visualize and analyze the pulsating flow field of the heart valve. Specifically, this application utilizes Digital Particle Image Velocimetry (DPIV) to visualize the pulsating flow field of the heart valve, thereby quantitatively analyzing the risk of thrombosis and potential hemolysis after implantation at the intended site. This DPIV technology utilizes sequential images, processed through image difference target detection and moving target tracking, to achieve full flow field detection of the fluid under complex conditions. The basic principle of DPIV technology is to disperse a large number of tracking particles that are distinguishable in color from the fluid medium and follow the flow path in the flow field, irradiate these flowing particles with planar light, and continuously photograph the measured flow field. By analyzing these particle images, the distance the particles travel within a certain time interval can be calculated, thereby determining the velocity at the particle's location.

[0049] exist Figure 1The system shown comprises a ventricular simulator, an atrial simulator, a highly transparent compliant valve testing chamber, a vascular compliance simulator, a vascular damping simulator, a high-speed camera, and a laser generator. Within this system, the ventricular simulator, atrial simulator, highly transparent compliant valve testing chamber, vascular compliance simulator, and vascular damping simulator are interconnected via pipes to form a loop. The highly transparent compliant valve testing chamber contains an artificial heart valve implant. During testing, the loop simulates the blood flow environment of the artificial heart valve implant within the human body through the ventricular simulator, atrial simulator, vascular damper, vascular compliance simulator, and highly transparent compliant valve testing chamber, thus providing accurate data support. The flow medium within the pipes contains a tracer particle suspension. A laser generator irradiates the highly transparent compliant valve testing chamber to create a visualized flow field. A high-speed camera acquires particle images of the implant after laser irradiation, and these images are uploaded to a computer for visual analysis of the heart valve pulsation flow field based on digital particle image velocimetry technology. By analyzing particle images captured by high-speed cameras using digital particle image velocimetry (DPV), various parameters in the flow field can be calculated, thereby enabling quantitative analysis of the risk of thrombosis and potential hemolysis after heart valve implantation at the intended site.

[0050] In some implementations of the embodiments of this application, transparent plexiglass is used to simulate the various organs in the circulatory loop in order to enhance the visualization of the flow.

[0051] In some implementations of this application, the artificial heart valve implant is one of the following: an artificial aortic valve, an artificial pulmonary valve, an artificial mitral valve, and an artificial tricuspid valve. Therefore, the artificial heart valve implant testing system proposed in this application possesses high flexibility and versatility, capable of testing the aforementioned four types of heart valves. Furthermore, the system adopts a modular design, allowing for customized fabrication of test chambers that closely approximate clinical anatomy for valves at different release locations, meeting standard requirements.

[0052] Understandably, the heart's circulatory system consists of two main parts: systemic circulation and pulmonary circulation. The heart valves through which blood flows and the order in which they pass differ depending on the circulatory pathway. In systemic circulation, blood flows sequentially through the left atrium, mitral valve, left ventricle, and aortic valve to the aorta; while in pulmonary circulation, it flows sequentially through the right atrium, tricuspid valve, right ventricle, and pulmonary valve to the pulmonary artery. Therefore, when testing different types of artificial heart valves, the connection order of the components in the testing system must be flexibly adjusted according to the actual location and function of the valve to ensure the accuracy and effectiveness of the test.

[0053] like Figure 2As shown, when the test subject is an artificial aortic valve or an artificial pulmonary valve, considering that these two valves are located at the exit points of the systemic and pulmonary circulations respectively, the circulation loop of the test system is designed with the atrial simulator 2, the ventricular simulator 1, and the highly transparent and compliant valve test chamber 3 connected in sequence. In this configuration, simulated blood in the tubing flows sequentially through the atrial simulator 2 to simulate the atrial contraction and blood ejection process, then enters the ventricular simulator 1 to simulate ventricular contraction and pressurization, and then passes through the artificial heart valve in the highly transparent and compliant valve test chamber 3 to evaluate its performance.

[0054] On the other hand, such as Figure 3 As shown, when the test subject is an artificial mitral valve or an artificial tricuspid valve, since these two valves are located between the left ventricle and left atrium, and the right ventricle and right atrium, respectively, the circulation loop of the test system needs to be adjusted so that the atrial simulator 2, the highly transparent compliant valve test chamber 3, and the ventricular simulator 1 are connected in sequence. In this mode, simulated blood first enters the atrial simulator 2, then flows through the artificial heart valve in the highly transparent compliant valve test chamber 3 and enters the ventricular simulator 1 to simulate the opening and closing state of the valve during ventricular filling, thereby evaluating its performance.

[0055] It should be noted that this application does not limit the specific connection order of the vascular compliance simulator 4 and the vascular damping simulator 5. When the artificial heart valve implant is an artificial aortic valve or an artificial pulmonary valve, it can be positioned anywhere between the atrial simulator 2 and the highly transparent compliance valve in the circulatory loop, according to the direction of medium flow. When the artificial heart valve implant is an artificial mitral valve or an artificial tricuspid valve, it can be positioned anywhere between the atrial simulator 2 and the ventricular simulator 1 in the circulatory loop, according to the direction of medium flow.

[0056] Furthermore, given the significant differences in the anatomical location and structural morphology of the aortic, mitral, tricuspid, and pulmonary valves within the heart, these differences will influence the corresponding design and fabrication strategies. Therefore, see [link to relevant documentation]. Figure 4 As shown in the embodiments of this application, in order to further improve the accuracy of the test, the model shown on the left is used as the benchmark for designing and manufacturing tooling for the aortic and pulmonary valves to ensure that the tooling can adapt to their specific anatomical characteristics. For the mitral and tricuspid valves, the model shown on the right is used to design and customize the manufacturing tooling to accurately meet their manufacturing requirements, thereby comprehensively covering and optimizing the manufacturing process of all key heart valves.

[0057] In some implementations of this application, the high-speed camera 6 employs a dual-frame mode to acquire particle images, thereby capturing detailed changes during high-speed dynamic processes. Specifically, the camera not only captures images continuously but also generates a pair of particle images with each capture. These two images are closely related and together constitute a particle image pair, serving as the basic unit for time series analysis, thereby enhancing the ability to capture minute changes.

[0058] Furthermore, to achieve precise time synchronization and data acquisition, a synchronizer controls the laser emission frequency to maintain consistency with the acquisition frequency of the high-speed camera 6, obtaining a series of time-series particle image pairs. Specifically, in this embodiment, both the laser generator 7 and the high-speed camera 6 are directly connected to the same computer, using the computer as a synchronizer. The synchronizer precisely synchronizes the laser pulse emission frequency with the image acquisition frequency of the high-speed camera 6 to 15Hz. In dual-frame mode, the camera is set to maintain a 0.2ms time interval between each pair of particle images to capture critical moments during the opening and closing of the artificial heart valve, including changes in its spatial position. By continuously capturing this series of particle image pairs, the spatial average of the valve at multiple time points can be accurately obtained, ensuring the accuracy of the test results.

[0059] In some implementations of this application, the ventricular simulator 1 uses a high-power voice coil motor as its core power source. This ensures that the system can output strong power to drive the circulating medium in the pipeline, while also giving the ventricular simulator 1 a high degree of adjustment flexibility.

[0060] Given the adjustable output curve of high-power voice coil motors, their output power can be precisely controlled based on preset parameters or real-time feedback. This allows for fine-tuning of the pressure of the flowing medium and cardiac output within the pipeline, simulating cardiac activity from normal heart function to various pathological states, thus mimicking the heart's working conditions under different physiological states. Therefore, by using high-power voice coil motors, the testing system can more realistically simulate the clinical conditions of different patient populations. Whether it's the strong heart of a young adult, the weakened heart of an elderly person, or the heart of a patient with various heart diseases, their unique physiological characteristics can be simulated by adjusting the motor's output curve. This provides a more clinically relevant testing environment for the performance evaluation of heart valve implants, ensuring the accuracy and reliability of the test results.

[0061] In some implementations of this application, the concentration of tracer particles directly affects the accuracy of the measurement results. Too high a particle concentration may significantly affect the flow itself, leading to two-phase flow problems; while too low a particle concentration will result in insufficient particle pairs in each interpretation region, thus affecting the accuracy of statistical analysis. Therefore, selecting an appropriate tracer particle concentration is crucial to ensuring measurement accuracy. In this application embodiment, during testing, after waiting for the pulsating flow field to reach a stable state, the concentration of the tracer particle suspension added to the flow medium in the pipe is 0.25%. It should be noted that this concentration is the optimal value obtained by the inventors after repeated experiments and optimizations. It ensures sufficient particle pairs in each interpretation region while avoiding significant impact on the flow itself, thus preventing the introduction of excessive two-phase flow problems and ensuring the accuracy of the measurement results is not affected by insufficient particle quantity.

[0062] In some implementations of this application, hollow glass beads are used as tracer particles in the tracer particle suspension. The hollow glass beads not only effectively reflect the specific wavelength of the laser beam, ensuring a clear and bright particle image under laser irradiation, but their excellent tracking ability also allows the particles to closely follow the movement trajectory of the flowing medium, thereby accurately reflecting the flow field information.

[0063] The following describes the application method of the system provided in this application, using practical application scenarios as examples:

[0064] First, the system can be divided into two parts: a circulation loop system and a measurement system. The circulation loop system consists of hardware such as a ventricular simulator 1, an atrial simulator 2, a highly transparent and compliant valve testing chamber 3, a vascular compliance simulator 4, a vascular damping simulator 5, a high-speed camera 6, and a laser generator 7, as well as pulsating flow performance testing software. The hardware can be controlled by the software to regulate and control pressure, cardiac output, temperature, etc., in a normal human body. The measurement system includes hardware such as the laser generator 7, the high-speed camera 6, and a synchronizer, as well as a data acquisition and analysis system developed based on the LabVIEW laboratory virtual instrument engineering platform. It can record the particle velocity field during multiple valve opening and closing cycles and automatically calculate the particle velocity field and shear field of the entire imaging area.

[0065] For each group of artificial heart valve tests, the cardiac output Q and system pressure range were changed by adjusting the amplitude of the drive motor in the ventricular simulator 1, the high transparency compliance valve test chamber 3, and the vascular damping simulator 5, in order to verify the valve's performance under various flow rate conditions, such as Q = 2.0, 3.5, 5.0, and 7.0 L / min.

[0066] After each pulsation condition was stabilized, a suitable concentration of tracer particle suspension was added. The position of the laser emitter was then adjusted using a support to ensure accurate laser illumination of the study area, guaranteeing clear tracer particle images. The laser emitted a wavelength of 532 nm and had a pulse frequency of 15 Hz. To ensure the particle images effectively reflected the flow field information, the selected tracer particles needed to effectively reflect the laser beam wavelength and possess good tracking ability. Therefore, hollow glass beads with a particle size of 5–20 μm were selected as the tracer.

[0067] After laser adjustment, the laser pulse frequency and camera acquisition frequency were synchronized to 15Hz using a LaVison PTU X synchronizer. The camera operated in dual-frame mode, recording a time series with particle image pairs as the basic unit, and setting the time interval between two images in each unit to 0.2ms. The camera position was then adjusted using a tripod to ensure the shooting range covered the expected analysis area. The particle images are shown below. Figure 5 As shown.

[0068] The flow field is visualized and analyzed using MATLAB in the Matrix Lab. Before analyzing the image results, the data units need to be converted. In this embodiment, the high-speed camera frequency acquisition and laser emission frequency are 15Hz, the interval between two consecutive frames used to calculate the flow field is 0.2ms, and the image resolution is 2360×1776 pixels. 2 This requires deriving and calculating a suitable image-to-object ratio. Simultaneously, it is essential to ensure that the displacement of the tracer particles between every two frames is controlled within 1 / 4 to 1 / 3 of the pane size to guarantee the reliability of the analysis data.

[0069] like Figure 6 As shown, time T1 represents the initial opening position of the valve, time T2 represents the maximum flow velocity during valve opening, time T3 represents the valve closing process, and time T4 represents the fully closed valve. The arrows indicate the direction of flow velocity. The evaluation includes measurements at multiple characteristic moments within a cardiac cycle, including the velocity field in the normal plane of the heart valve axis during systole and diastole, and the shear stress field and vorticity field are derived from the calculated velocity field.

[0070] Excessive shear stress may damage red blood cells, causing hemolysis or damaging the endothelium of blood vessel walls; abnormal shear stress can also alter the biological behavior of certain cells, such as activating platelets in the blood, leading to thrombus formation; backflow and separation flow in blood flow can damage the blood, and in the backflow zone and eddy zone, activated platelets and lipids are prone to aggregate. This usually occurs behind high shear stress and is prone to plaque formation in the flow field.

[0071] See Figure 7This application utilizes a self-developed software system to directly derive and calculate the shear field of velocity particles in the flow field, thus providing a visual representation of the shear force distribution in the post-valve flow field and enabling assessment of thrombosis and potential hemolysis risks. The shear stress field distribution indicates that the shear stress value is within the safe range of 1 Pa to 7 Pa. The shear stress reaches its maximum when the heart valve is fully open. As the heart valve begins to close, the velocity gradually decreases, and the velocity gradient also decreases simultaneously. When the heart valve is completely closed, the shear stress approaches zero.

[0072] See Figure 8 As shown in the embodiments of this application, a testing method for an artificial heart valve implant is also provided, the method comprising:

[0073] S801: An artificial heart valve implant is placed in a highly transparent compliance test chamber, and the blood flow environment in the human body is simulated within the highly transparent compliance test chamber.

[0074] In the embodiments of this application, the artificial heart valve implant to be tested is first installed in a highly transparent and compliant test chamber; then, the blood flow environment close to that in the human body is precisely simulated in the test chamber to ensure the accuracy and reliability of the test.

[0075] S802: Irradiate the high transparency compliance test chamber with laser light. The flow medium in the high transparency compliance test chamber contains a suspension of tracer particles.

[0076] In the embodiments of this application, a laser beam is irradiated into a pre-set high-transparency compliance test cavity using a laser generator. Simultaneously, an appropriate amount of tracer particle suspension is injected into the flowing medium. The tracer particles must possess good laser reflectivity and tracking ability to ensure that they can accurately reflect changes in the flow field.

[0077] S803: Acquire particle images of the artificial heart valve implant after laser irradiation, and generate an analysis view of the heart valve pulsating flow field based on the particle images.

[0078] In the embodiments of this application, under laser irradiation, a high-speed camera captures particle images behind the implanted artificial heart valve. These particle images record the trajectories of tracer particles flowing with the fluid, reflecting the influence of the heart valve on blood flow. Subsequently, digital particle image velocimetry is used to perform in-depth analysis on the acquired particle images to generate an analytical view of the pulsating flow field of the heart valve, providing intuitive data support for evaluating the performance of the heart valve and enabling quantitative analysis.

[0079] In some implementations of this application, the analysis view is a particle velocity field analysis view, which is used to describe the particle velocity distribution in the normal plane of the heart valve axis at multiple systolic and diastolic moments within at least one cardiac cycle.

[0080] The particle velocity field analysis view is used to describe the velocity and direction of particles in a fluid medium. This is used to study the dynamic characteristics of blood flow within the heart.

[0081] Specifically, the cardiac cycle refers to the entire process of the heart completing one contraction and relaxation. It can be one or more cycles to provide a more comprehensive view of the heart's performance at different stages. The particle velocity distribution in the normal plane of the heart valve axis refers to the velocity distribution of particles in the flowing medium along the normal direction of the plane containing the heart valve axis. This can be used to analyze the changes in blood flow velocity near the heart valve when it opens and closes, which is helpful for assessing the functional status of the heart valves and diagnosing related diseases.

[0082] In some implementations of the embodiments of this application, the method further includes the following steps:

[0083] A particle shear stress field analysis view is generated based on the particle velocity distribution in the normal plane of the heart valve axis at multiple systolic and diastolic moments within at least one cardiac cycle. The particle shear stress field analysis view is used to describe the particle shear stress distribution in the normal plane of the heart valve axis at multiple systolic and diastolic moments within at least one cardiac cycle.

[0084] Shear stress, a concept in fluid dynamics, describes the force generated within a fluid or between a fluid and a solid boundary due to velocity differences. This application's embodiments visualize the shear stress distribution behind the flap by generating a particle shear stress field analysis view.

[0085] Finally, it should be noted that in the embodiments of this application, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0086] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A testing system for artificial heart valve implants, characterized in that, The system includes: a ventricular simulator, an atrial simulator, a highly transparent and compliant valve testing chamber, a vascular compliance simulator, a vascular damping simulator, a high-speed camera, and a laser generator; The ventricular simulator, the atrial simulator, the highly transparent compliant valve test chamber, the vascular compliance simulator, and the vascular damping simulator are interconnected by pipes to form a circulation loop. An artificial heart valve implant is installed in the highly transparent compliant valve test chamber. During the test, the circulation loop simulates the blood flow environment of the artificial heart valve implant in the human body. The ventricular simulator is used to provide power for the flowing medium in the pipeline; wherein, the flowing medium in the pipeline contains a tracer particle suspension. The atrial simulator is used to store the flow medium within the tube; The vascular damper is used to provide resistance to the flow medium within the pipeline; The vascular compliance simulator is used to provide pulse pressure for the flowing medium within the pipeline; The highly transparent and compliant valve testing cavity, made of a highly transparent and compliant material, is used to provide an imaging window for the high-speed camera and to simulate the interaction between the valve and surrounding tissues. The laser generator is used to irradiate the highly transparent and compliant valve test cavity with laser light; The high-speed camera uses a two-frame mode to acquire particle image pairs after laser irradiation of the artificial heart valve implant. The particle image pairs are then uploaded to a computer for visual analysis of the heart valve pulsating flow field based on digital particle image velocimetry technology, in order to quantitatively analyze the risk of thrombosis and potential hemolysis after the heart valve is implanted at the intended site. The highly transparent and compliant valve testing chamber is made of highly transparent silicone material. The temperature of the flowing medium in the circulation loop is controllable. The high-speed camera uses a dual-frame mode to acquire particle image pairs and retains a time interval of 0.2ms between each pair of particle images.

2. The system according to claim 1, characterized in that, The artificial heart valve implant is one of the following: artificial aortic valve, artificial pulmonary valve, artificial mitral valve, and artificial tricuspid valve.

3. The system according to claim 2, characterized in that, When the artificial heart valve implant is the artificial aortic valve or the artificial pulmonary valve, the atrial simulator, the ventricular simulator, and the highly transparent compliant valve test chamber are connected in sequence in the circulatory loop.

4. The system according to claim 2, characterized in that, When the artificial heart valve implant is the artificial mitral valve or the artificial tricuspid valve, the atrial simulator, the highly transparent compliance valve test chamber, and the ventricular simulator are connected in sequence in the circulatory circuit.

5. The system according to claim 1, characterized in that, The ventricular simulator specifically uses a high-power voice coil motor to regulate pressure and cardiac output, providing power for the flowing medium within the pipeline.

6. The system according to claim 1, characterized in that, The tracer particle suspension uses hollow glass beads as tracer particles.

Images