Testing Prosthetic Heart Valves

Real-time wear testing device for cardiovascular implants that accurately simulates human body conditions to evaluate the durability of artificial heart valves. The device allows testing at physiological frequencies and pressure curves to closely mimic the human heart. One-way valves prevent test fluid from flowing up in chambers and backpressure from affecting test results. The device has separate test channels with adjustable flow rates, pump components, and cameras to monitor valve function during testing.

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An individualized assessment system to predict mismatch between prosthetic valves and patient anatomy before transcatheter aortic valve replacement (TAVR) surgery. The system allows preoperative testing to evaluate if a specific prosthetic valve size will properly fit the patient's native valve annulus. It uses a test platform with an artificial valve mounted on it, connected to pressure regulators and a pump. The system pumps blood through the valve at physiological pressures to simulate TAVR conditions. Sensors monitor flow and pressure to calculate metrics like effective orifice area (EOA) and mean gradient. These values can indicate potential mismatch and help choose the optimal prosthetic valve size for the patient.

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Artificial heart valve durability testing device and method to reduce excess pressure loads during testing to prevent valve failure. The device has an outer shell, inner cylinder, and elastic member. The inner cylinder holds the valve. When the valve closes, pressure builds. The elastic member compresses as pressure exceeds a threshold. The inner cylinder moves backward with the valve to relieve excess pressure through a return channel. This reduces peak pressure on the valve compared to conventional testing.

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A pressure testing device for artificial heart valves to accurately measure the reverse burst pressure. It uses a chamber with a clamp to hold the valve, a liquid supply mechanism to fill the chamber, and a tank with drain pipe. The mechanism pumps fluid into the chamber using pistons and check valves. A servo motor drives the pistons to alternate rising and falling. When the chamber pressure exceeds the valve's reverse burst point, the valve fails and the solution drains into a measuring cylinder. This provides a quantitative measurement of the burst pressure.

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A method and tooling for fatigue testing of heart valve leaflets without requiring complete valves. The testing involves fixing multiple cut leaflets between upper and lower toolings and applying compressive and torsional forces to simulate valve motion. This allows fatigue testing of just the leaflet material, reducing costs and complexity compared to whole valve testing. The tooling has clamps to fix the leaflets, driving units for forces, and parallel toolings for leaflet motion.

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An artificial heart valve testing device that allows realistic simulation of valve dysfunctions like regurgitation, prolapse, and chordae tendineae rupture for testing and development of artificial heart valves. The device has a pipeline system with an artificial valve system inside. The valve system has a fixing part, an adjusting part, a limiting part, and a mounting bracket for the valve leaflets. The adjusting part connects to the leaflets and passes through a channel in the bracket. A motorized runner moves the adjusting part to change the leaflet overlap area and simulate valve dysfunctions.

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A simplified device for pre-checking the opening and closing state of heart valve prostheses before implantation. The device has an observation cavity, a loading cavity, a pressure supply, and connecting pipes. The valve prosthesis is loaded into the loading cavity and connected to the observation cavity via the pipes. The pressure supply is used to inject fluid into the loading cavity to simulate blood flow. This allows visual observation of the valve's opening and closing in a closed system without the need for multiple valves and complex fluid circuits.

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Testing prosthetic valves that are reliable and operate according to desired testing protocols. The testing comprises a test chamber divided into two chambers, one of which has a fluid connection path between the inflow chamber and the outflow chamber, one of which has a mount for supporting a prosthetic valve under test in the fluid connection path with the prosthetic valve oriented to open to pass flow on the fluid connection path from the inflow chamber toward the outflow chamber and to close to restrict flow on the fluid connection path toward the inflow chamber from the outflow chamber, a fluid driving device operable to vary a pressure differential of a fluid between the inflow chamber and the outflow chamber in repeating cycles which include an open phase in which the valve under test is open and a closed phase in which the valve under test is closed; and a fluid driving device operable to vary a pressure differential of a fluid between the inflow chamber and the outflow chamber in repeating cycles which include an open phase in which the valve under test is open and a closed phase in which the valve under test is closed; and a source of fluid at the inflow chamber that maintains a mean fluid pressure in the inflow chamber.

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Device for leakage testing of prosthetic heart valves that improves accuracy and reproducibility of testing compared to existing methods. The device allows precise control over the liquid pressure applied to the valve leaflets during testing by adjusting the height difference between the surge tank and valve connection device. This eliminates discrepancies due to variations in operator positioning. The device also features a sliding table, anti-splash shell, and valve fixing tube to improve test setup and consistency.

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Modular human heart valve pulsating flow performance testing machine that allows customization and flexibility for testing different types of heart valves. The machine consists of detachable modules that can be assembled in different configurations to simulate pulsatile flow for testing arterial and atrioventricular valves separately. The modules include linear motors, damping mechanisms, thermostats, and other components that can be mixed and matched to mimic the unique flow patterns of different valve locations. This modular design allows adapting the machine to test various heart valve types on a single platform, avoiding the limitations of fixed configurations and large, inflexible machines.

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Aortic prosthetic heart valve hydrodynamic testing device to simulate and test the fluid dynamics of aortic artificial heart valves. It has an outer cylinder with upper and lower ends that open. An aortic root simulation pipeline passes through the cylinder, connecting the aortic compliance cavity and ventricular chamber. The pipeline contains a simulated blood solution with fluorescent particles. A valve is inside the pipeline. A laser tube on the cylinder side can illuminate the fluorescent particles. This allows PIV (Particle Image Velocimetry) testing of the prosthetic valve flow using fluorescent particles and laser illumination.

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An in vitro heart valve testing system that accurately simulates heartbeat for testing artificial heart valves before implantation. The system has separate chambers for simulating the atrium, ventricle, and valves, connected in a loop for circulating fluid. A water bath heater and pump provide warm circulating fluid similar to body temperature. The loop structure allows simulating heartbeat pulsations and flow. The chambers are arranged vertically with the atrium above the ventricle. The valve simulation chambers are above their respective test chambers. The chambers are connected in a sequence suitable for circulating fluid flow.

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An extracorporeal heart valve testing system that accurately simulates the beating and blood flow conditions of a human heart. The system uses water-filled chambers arranged in a sequence representing the atrium, ventricle, and valves of the heart. It has chambers for simulating the atrium, ventricle, and valves, with a water bath and pump to circulate warm water through them. The chambers are connected in sequence to mimic the heart's flow. The water-filled chambers provide a realistic pulsation and blood flow environment for testing heart valves before implantation.

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In vitro simulation system for interventional surgery using isolated animal hearts to more accurately and realistically test medical devices like prosthetic heart valves before human implantation. The system involves isolating an animal heart, placing it in a containment area, and connecting sensors and monitors to collect data during device testing. This allows evaluating device performance in a more representative heart structure and environment compared to artificial models.

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A wear testing device for artificial heart valves that allows continuous testing of valve durability and performance. The device has a base, a box structure, a testing mechanism, and a drive mechanism. The box has a compartment for installing the valve, a separate compartment for fluid, and a movable piston. The drive mechanism moves the piston to simulate blood flow through the valve while circulating fluid between the compartments. Cameras, sensors, and heating can be added for monitoring and control. The removable box cover allows easy valve access.

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Artificial heart valve pulsatile flow performance testing device with simplified design for mass production quality inspection of artificial heart valves. The device allows testing of heart valve pulsatile flow performance in vitro for safety and effectiveness evaluation. The device has a main body with lower and upper flow channels. The lower channel connects to the ventricle, valve, and compliance unit. The upper channel connects to the valve and storage unit. The device allows swapping the valve and discharging the upper flow channel without losing the lower flow. This reduces liquid consumption and simplifies valve replacement compared to full pulse simulation devices. The device also has features like pressure sensors, discharge ports, and isolation membranes.

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Bionic device and testing method for accurately simulating and testing the mechanical fatigue performance of heart valves to evaluate their longevity in artificial valve replacements. The device has a driving mechanism, liquid storage tanks, gas cylinder, elastic diastolic chamber, heart valve mounting platform, and ventilation pipes. The driving mechanism moves a piston in the gas cylinder to simulate heart contractions. Liquid is pumped into the diastolic chamber to simulate blood fill. The valve is mounted between the chambers. The method involves operating the driving mechanism to repeatedly expand and contract the chambers to test valve fatigue.

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Integrated system for testing durability of prosthetic heart valves using a high-speed camera. The system has multiple independent valve testing units connected to a computer, data acquisition unit, and motion control unit. A high-speed camera is connected to the computer. The valves are tested under controlled conditions using the motion control unit. The valve opening and closing motion is recorded using the high-speed camera. The videos are analyzed to assess valve durability and compare it to tests without visual recording. The integrated system provides automated, consistent, and comprehensive valve testing with visual documentation.

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Using a pressure guidewire and a second pressure sensor in adjacent cardiac regions during structural heart procedures to assess valve function. The guidewire measures pressure in one region and the second sensor measures nearby. Features like dicrotic notches and systolic/diastolic phases are detected in both. Calibration adjustments are made based on simultaneous pressure values. This allows comparison and determination of valve conditions like regurgitation or gradient changes.

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A stable and adjustable extracorporeal circulation pulsatile flow simulation system for testing artificial heart valves. The system accurately simulates physiological conditions to evaluate artificial heart valve performance. It uses components like an airtight container to simulate arterial compliance, a sealed air volume to adjust aortic compliance, and a pulsation drive for the left ventricle. This allows adapting to various physiological states and testing different types of artificial heart valves.

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Artificial prosthesis detection device with low price and long service life for testing of medical devices like artificial heart valves. The device has multiple independent test chambers with closed flow channels for simultaneous testing of multiple prostheses. It uses a reciprocating drive mechanism with a driving part that squeezes an elastic member to open the prosthesis valve. The elastic member pulls back to close the valve. This replaces traditional bellows that wear out in fatigue testing. The closed flow channels with heating plate maintain consistent liquid temperature. A balance plate prevents vibration. Multiple chambers allow simultaneous testing and higher throughput compared to single chamber devices.

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Vertical mounting table for testing artificial heart valves with adjustable anti-stress testing capabilities. The table has a vertical configuration with a bottom box, partition, and cover. The bottom box has limit seats and slots for sliding blocks to restrict valve movement. The cover has a test box with flaps for performance testing. The anti-stress adjustment device has a motor, screw, blocks, rods, and sliding sleeve to apply tension to the valve. This allows testing of valve flexibility under pressure. The table allows multiple performance tests on a single vertical installation.

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A simulated heart valve test system to study heart valve disease by replicating the valve's motion and fluid dynamics in a controlled environment. The system includes a water tank, valve model, pump, fluid monitoring, imaging, and operating components. It allows simulating valve opening/closing in a flow environment to investigate valvular disease mechanisms, progression, and outcomes. The system provides a platform to study heart valve diseases from a fluid mechanics perspective, starting from fundamental mechanisms to study pathogenesis, pathogenesis, and outcomes of valvular disease. It enables early diagnosis, intervention, and treatment of valvular disease by mimicking the physiological conditions of the heart valve in the body.

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Simplified and more accurate testing of prosthetic medical devices like heart valves using a compact and calibrated test apparatus. The apparatus has two fluid drivers at the inlet and outlet ends of a flow channel to pump test fluid through the prosthetic device. This allows measuring device performance like flow rate and pressure gradients. The apparatus is calibrated using a device with known dimensions to accurately scale images of the prosthetic device to real-world distances. This enables precise measurements of leaflet motion and leakage.

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Improved hydrodynamic testing of prosthetic heart valves and conduits to simplify testing and provide more accurate results. The testing system involves a single apparatus that can test both forward flow pressure drop and backward flow leakage in a continuous flow environment. The apparatus includes a test chamber with a prosthetic valve mounted within it and sensors to measure flow rate, pressure, and leakage. A control system automatically adjusts flow conditions to specified levels and records the performance metrics.

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A mechanical heart valve simulation detection device for accurate testing of mechanical heart valve switching and compression characteristics. It uses a setup with a simulated heart containing two identical valve detection units flanking the actual valve. This allows simultaneous measurement of valve pressure and switch motion. A blood circulation system connects inlet and outlet pipes. A fixed structure holds the valve in the simulated heart. The device provides an isolated, compact, and observable platform for mechanical heart valve testing.

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A test system and method to simulate the flow environment inside the body for testing heart valve models. The system has features like a fluid tank, fluid monitoring, imaging, and an operating channel. The fluid tank contains the valve model and simulates the flow conditions inside the body. Fluid flow is monitored in real-time. An imaging system tracks the valve position. An operating channel extends into the tank to allow manipulation of the valve model. The system provides a way to test heart valve models in a simulated body flow environment for studying valvular disease mechanisms and developing better valve replacement devices.

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A comprehensive testing device for evaluating the performance of heart valve replacement devices. The device can simulate the dynamic conditions of the human heart and blood flow to test multiple parameters like strain, vibration, pressure difference, area, and durability simultaneously. This allows comprehensive evaluation of heart valve replacements compared to prior devices that only tested single parameters. The device has a multi-function test bench, storage tank, power unit, microcontroller, and computer. It can test mechanical, biological, and cusped valves like mitral, aortic, and tricuspid. The compact design enables easy portability for improved testing efficiency.

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A heart valve flow performance detection device for accurately testing the hemodynamic performance of artificial heart valves. The device allows realistic simulation of physiological conditions like blood flow, pressure, and compliance. It has modules for the ventricle, atria, blood flow resistance, and valve installation. Fluid is connected between modules using tubes with a valve to control flow. An isolated "pig heart" can be connected to simulate physiological conditions. This enables comprehensive testing of artificial heart valves including imaging the valve during pulsation cycles.

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Valve function testing equipment for testing prosthetic heart valves to evaluate their performance and durability. The equipment uses a compact cylinder mechanism with an integrated one-way valve on the piston assembly. This allows simulating a test cycle by reciprocating the piston assembly to push fluid through the valve and return path. The one-way valve isolates the fluid during piston movement to maintain stable pressure on the valve for accurate testing. The compact setup with integrated valve and backflow path provides a simple, isolated liquid model for prosthetic heart valve testing.

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A method for testing the flexibility of prosthetic heart valve leaflets to facilitate proper functioning of the valves. The method involves draping multiple leaflets over a series of bars and capturing an image of them. Computer analysis of the image is used to assign flexibility values to the leaflets. The leaflets are then categorized based on their flexibility values. By sorting and grouping the leaflets based on flexibility, it allows optimal matching of flexible leaflets for sewing together in prosthetic valves to minimize regurgitation.

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An in vitro testing system for heart valves that can accurately evaluate the performance of different types of heart valves like mitral, aortic, tricuspid, and pulmonary valves using a universal test setup. The system has a simulated heart connected to left and right cardiac circulatory systems. It uses a power device to provide power to the simulated heart and a fluid storage device to provide circulating fluid. A monitoring device detects pressure changes before and after valve release. The system allows testing valves like mitral and aortic in the left circulatory system, and tricuspid and pulmonary in the right system. This provides a versatile, cost-effective, and efficient way to test heart valve performance without having to build specific test setups for each valve type.

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Testing apparatus for prosthetic heart valves that can accurately measure flow properties, leaflet coaptation, and leakage of prosthetic valves under physiological conditions using a simplified design. The apparatus flows test fluid through the valve in both directions when open and applies pressure profiles when closed. Images are captured to analyze leaflet coaptment. A calibration device with spaced walls helps correct for optical distortion in the images.

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A heart valve steady-state leakage test device and method for accurately testing artificial heart valves to ensure quality and safety. The device uses a water storage bucket with an air source to repeatedly fill and empty the test chamber. A pressure sensor measures the chamber pressure, a tension sensor weighs the chamber volume change, and a calibration procedure determines the force change per milliliter of water. This avoids manual weighing errors and liquid sloshing. The device also has a tooling fixture with inner and outer rings to clamp the valve.

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Extracorporeal circulatory system for testing artificial hearts that simulates human blood flow and organ perfusion to accurately test artificial hearts before implantation. The system has components for left and right ventricle simulation, pulmonary circulation, and systemic circulation. The ventricle simulation uses a linear motor, flexible connector, and piston cylinder to mimic heart beats and load changes. A perfusion simulator with adjustable flow and container levels replicates organ perfusion states. This allows testing artificial hearts with different blood paths and perfusion levels to optimize performance.

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A portable, multifunction testing system for prosthetic heart valves that can be used on production lines to evaluate valve quality and performance. The system combines features of steady flow testing and pulse duplication to provide accurate and repeatable testing results. It uses a circuitous flow channel with a piston driven linear motor to apply pulsating flow. The valve is held in place and can be tested in steady flow conditions for duration and leakage, as well as pulsed flow to evaluate opening and closing behavior. The system can use biocompatible materials for sterilization.

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Prosthetic heart valve with integrated sensors for monitoring valve performance after implantation. The sensors are designed to attach securely to the stent of the valve in a collapsed state for delivery. The sensors can measure physiological data like pressures and flows to monitor valve function. The sensors have features like finger channels or chamfered heads to attach to the valve stent struts. This allows accurate monitoring of prosthetic valve performance in vivo and helps diagnose issues like leakage or calcification.

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Universal in vitro testing system for heart valves that allows testing of different types of heart valves using a single setup. The system has a circulatory device that connects to a simulated heart to create left and right cardiac circulatory systems. Valves can be tested by delivering an interventional valve into the circulatory systems. Pressure monitors detect changes before and after valve release. This allows comprehensive evaluation of valve performance, including regurgitation and paravalvular leakage, for mitral, aortic, tricuspid, and pulmonary valves using a common setup.

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Artificially implanted mechanical heart valve bionic test simulation dynamic device that allows accurate dynamic testing of heart valve prostheses. The device has a bionic chest cavity with a heart simulation unit containing a silicone valve chamber. A circulatory unit pumps blood through the valve chamber. A detection unit monitors valve performance. This allows testing close to physiological conditions to evaluate prosthetic heart valve durability, flow dynamics, and other parameters. The bionic test setup provides more accurate and comprehensive evaluation compared to static lab tests.

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Functional testing system for artificial heart valves that accurately simulates the human body environment for more realistic and reliable performance testing. The system uses a human body simulation mechanism, monitoring, and control components. The simulation mechanism has a heart pump, circulation circuit with ventricle, shunt, aorta, valve, atrium, compliance chamber, and catheters. It allows simulating heart structure, blood flow, damping, compliance, and transparency. The system automates testing by integrating the simulation, monitoring, and control components.

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Steady-state leakage test device for artificial heart valves that provides stable liquid level and pressure for accurate testing. The device has a tank containing simulated blood fluid, a detection component, a liquid control tube, and a regulating tube. The control tube connects below the tank-detection connection and above the tank-regulating connection. The regulating tube slides vertically. This configuration stabilizes the liquid level in the tank, prevents air pockets, and maintains consistent pressure when pumping fluid to the detection component.

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Optimizing heart valve replacement to reduce the risk of post-surgery aortic regurgitation by accurately simulating the behavior of the aortic root and valve tissue during TAVR. The simulation involves extracting biomechanical features using finite element methods to predict the stress and displacement of the aortic tissue around the prosthetic valve. It also calculates the force distribution on the aortic root and valve after virtual valve replacement. This simulation helps identify optimal valve size and deployment location to minimize stress and prevent aortic regurgitation.

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An artificial heart valve function testing system that more accurately simulates the human cardiovascular system compared to existing systems. The system has a human body simulation mechanism, a monitoring mechanism, and a control mechanism. The simulation mechanism includes a pump and circulation circuit with components like ventricle, aortic stent, valve, shunt, catheters, and compliance chamber. This allows testing of artificial heart valves in a more realistic and controllable environment.

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An in vitro testing system and method for evaluating the performance of transcatheter mitral valve stents. The system has a component with a mitral valve stent under test, a circulation device to provide fluid flow, and monitoring devices. The testing involves connecting the stent component to a heart specimen and circulating fluid through it to simulate blood flow. This allows evaluation of stent function, fixation, and durability. The heart specimen enables testing the stent's impact on surrounding tissue and assessing paravalvular leakage. The circulation device can provide steady or pulsating flow to mimic physiological conditions. The temperature is controlled to simulate body temperature.

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A system for in vitro testing of catheter-delivered mitral valve replacements to evaluate their performance characteristics. The system includes a test component with the mitral valve prosthesis, a circulatory loop with adjustable resistance, and monitoring devices to assess valve function, fixation, and leakage. The loop simulates the left ventricle, aorta, and pulmonary veins for realistic testing. It allows analyzing factors like valve opening, closure, and regurgitation at different pressures and flow rates.

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Simulated blood flow system for evaluating vascular implants without needing human trials. The system has a simulated blood vessel, simulated heart, and simulated blood circulating through the vessel. The blood vessel has connections that fit implants. A control device monitors pressure, flow, and temperature. An evaluation device assesses implant performance based on detected parameters. This allows testing implants in a realistic simulated environment to evaluate factors like displacement, twist, fatigue, and opening without using humans.

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Accelerated life testing system for valves like heart valves to simulate and accelerate the aging process for durability testing. The system has a chamber with a valve holder, fluid displacement member, and actuator. The chamber has return flow orifices connecting the proximal and distal spaces. A camera, lights, and pressure sensors monitor the valve during cycling. The chamber can tilt, and the lights illuminate at rate correlated to actuation. The system adjusts valve area based on indication from the camera, and the lights are controlled to match valve cycling rate.

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Apparatus and methods for testing replacement heart valves that provides reliable and accurate testing while complying with standards like ISO 5840. The testing system uses a non-sinusoidal motion for the fluid impeller to drive the flow through the valve, which mimics more realistic physiological conditions. It also has a controllable bypass valve to limit reverse pressures applied to the valve. A pressure control system with compliance devices upstream and downstream regulates pressures. This allows accurate accelerated testing without excess spikes or reverse pressure failures.

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A cardiac simulator for detailed hydrodynamic analysis of mitral, aortic and endoprosthetic heart valves. The simulator has a malleable, multipositional ventricle model that can replicate human postural changes. It allows detailed hydrodynamic analysis of prosthetic heart valves using non-invasive anemometry techniques like PIV and LDA. The simulator's ventricle model is anatomically accurate and can be positioned in any orientation to replicate realistic flow conditions. It also has features like compliance chambers, adjustable pressure pears, and an electromagnetic flow meter for accurate flow measurement. The simulator's modular design allows easy maintenance. By having a fixed refractive index and using non-invasive measurement techniques, the simulator avoids the need for cumbersome refractive index matching fluids.

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Accelerated life testing system for prosthetic heart valves that allows testing of valves at faster than physiological cycle rates to accelerate wear and failure analysis. The system has features like adjustable return flow orifices, lighting, camera, and pump rate synchronization to optimize valve testing conditions. It also allows independent testing of multiple valves. The valve holder, chambers, and pump form a sealed loop for cycling the valve at high rates. The orifices can be adjusted to fine-tune flow conditions for testing different valve types. Cameras capture valve images for analysis and synchronize with pump rate. Lights illuminate the valve based on pump rate. The system can also use multiple chambers with valves tested simultaneously.

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