Heart valve testing apparatus and methods
First Claim
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1. Apparatus for testing replacement heart valves, the apparatus comprising:
- a mounting structure for supporting a heart valve in a passage extending between first and second chambers;
a driving system for driving a flow of fluid through the heart valve supported on the mounting structure, the driving system comprising an actuator and a controller connected to control the actuator to provide a desired non-sinusoidal motion to a fluid impeller; and
a pressure control system, the pressure control system comprising one or more compliance devices which can temporarily receive some fluid, one or more of the compliance devices being adjustable;
wherein the pressure control system comprises a bypass providing a fluid connection between the first and second chambers and one or more bypass valves controllable to regulate a flow of fluid through the bypass.
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Abstract
Methods and apparatus for accelerated wear testing of prosthetic heart valves apply non-sinusoidal pressure waveforms. The waveforms may maintain a threshold reverse pressure for a desired duration while limiting a peak reverse pressure. Apparatus may include a fluid impeller such as a bellows or a piston driven by an actuator having a position controlled by a motion control system. The apparatus may include a pressure control system comprising one or more bypass channels and bypass valves controlling a resistance of the bypass channels to fluid flow. The bypass valves may be controlled in real time.
39 Citations
34 Claims
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1. Apparatus for testing replacement heart valves, the apparatus comprising:
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a mounting structure for supporting a heart valve in a passage extending between first and second chambers; a driving system for driving a flow of fluid through the heart valve supported on the mounting structure, the driving system comprising an actuator and a controller connected to control the actuator to provide a desired non-sinusoidal motion to a fluid impeller; and a pressure control system, the pressure control system comprising one or more compliance devices which can temporarily receive some fluid, one or more of the compliance devices being adjustable; wherein the pressure control system comprises a bypass providing a fluid connection between the first and second chambers and one or more bypass valves controllable to regulate a flow of fluid through the bypass. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A method for testing replacement heart valves, the method comprising:
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controlling an actuator to, in a first period, cause a flow of fluid through a heart valve under test in a forward direction wherein the heart valve is open; controlling the actuator to, in a second period, cause a flow of fluid in a reverse direction that causes the heart valve to close and applies a reverse pressure to the heart valve; and allowing a compliance device to temporarily receive some fluid during the testing; wherein during the second period; the actuator is controlled to apply a non-sinusoidal pressure waveform to the closed heart valve and the method further comprises adjusting the compliance device; and a flow of fluid is controlled through a bypass channel to limit a reverse pressure on the heart valve. - View Dependent Claims (33)
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34. Apparatus for testing replacement heart valves, the apparatus comprising:
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a mounting structure for supporting a heart valve in a passage extending between first and second chambers; a driving system for driving a flow of fluid through the heart valve supported on the mounting structure, the driving system comprising an actuator operable to move a fluid impeller to, in a first period, cause a flow of fluid through the heart valve under test in a forward direction wherein the heart valve is open; and
, in a second period cause a flow of fluid in a reverse direction that causes the heart valve to close and applies a reverse pressure to the heart valve;a pressure control system comprising a bypass extending between the first and second chambers, a bypass valve in the bypass, the bypass valve controllable to alter a resistance of the bypass valve to fluid flow and a pressure sensor and one or more compliance devices which can temporarily receive fluid; and a controller configured to control the bypass valve in response to a pressure sensed by the pressure sensor to limit the reverse pressure applied to the heart valve in the second period.
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Specification