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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