Apparatus for testing prosthetic heart valve hinge mechanism
First Claim
1. An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprisingmeans for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing,means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, andmeans for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
6 Assignments
0 Petitions
Accused Products
Abstract
An apparatus for proof testing mechanical heart valve prostheses. The apparatus also provides an in vitro test environment simulating in vivo loads, providing a function test. If the heart valve passes the pivot proof test, a function test is performed. The apparatus first directs a pressurized back flow against the tested valve, closing the valve and applying pressure against the leaflet occluders well beyond the maximum functional in vivo load. The heart valve is positioned so that the leaflets assume their "worst-case" position, that is, the heart valve is oriented so that all the necessary play or gap between the leaflet pivots and pivot recesses is subsumed at one location, thus representing the most severe condition that might be experienced with a heart valve in use. The heart valve is loaded by back pressure applied through a working fluid. Pressure transponders detect the pressure on each side of the heart valve, to determine if a valid test has been performed.
39 Citations
22 Claims
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1. An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising
means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
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2. An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising
means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for turning said part to selected worse-case orientations, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being sufficient to provide a selected energy of fracture.
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11. A method for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said method comprising the steps of
holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure exceeding 22 psi and being sufficient to provide a selected energy of fracture.
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12. A method for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said method comprising the steps of
holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, turning said part to selected worse-case orientations, directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, and maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being in excess of expected diastolic pressure.
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21. An apparatus for proof testing at least part of a mechanical prosthetic heart valve, said part including at least one leaflet and a valve body holding said leaflet, said apparatus comprising
means for holding said part of said mechanical prosthetic heart valve in a selected position for proof testing, means for directing a working fluid against said at least one leaflet and for forcing said leaflet into a closed position impeding flow of said working fluid, said means for directing a working fluid comprising means for controlling a rate of flow of said working fluid, means for maintaining an elevated back pressure against said leaflet for a selected period of time, said back pressure being sufficient to provide a selected energy of fracture, means for sensing said back pressure, means for incrementally raising said flow rate to attain said elevated back pressure.
Specification