Paravalvular leak test apparatus and method
First Claim
Patent Images
1. An apparatus for testing paravalvular leakage, comprising:
- a pulse chamber pressure vessel having a top, a bottom, at least one side, an interior volume, an inlet and an outlet;
at least one valve mounting opening in the bottom of the pulse chamber pressure vessel, the valve mounting opening in fluid communication with the interior volume;
a flexible valve ring mounting member mounted about each valve mounting opening for mounting a sewing ring of a prosthetic heart valve thereto, said mounting member being an annular member having a central opening for receiving at least part of the prosthetic heart valve, wherein the prosthetic heart valve contains movable elements;
a pulsatile pump, having an inlet and an outlet, wherein the pump outlet is fluidly connected to the inlet of the pulse chamber pressure vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber pressure vessel; and
,a drip collection chamber vessel having an inlet and an outlet, the drip collection chamber vessel in fluid communication with each prosthetic heart valve to collect paravalvular leakage.
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Abstract
An apparatus and method for measuring paravalvular leakage from a prosthetic heart valve in vitro. The apparatus has a pulse chamber pressure vessel and a pulsatile pump. The sewing ring of a prosthetic heart valve is mounted to a mounting member which is affixed to the pressure chamber, and paravalvular leakage from the heart valve is collected and measured.
101 Citations
21 Claims
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1. An apparatus for testing paravalvular leakage, comprising:
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a pulse chamber pressure vessel having a top, a bottom, at least one side, an interior volume, an inlet and an outlet; at least one valve mounting opening in the bottom of the pulse chamber pressure vessel, the valve mounting opening in fluid communication with the interior volume; a flexible valve ring mounting member mounted about each valve mounting opening for mounting a sewing ring of a prosthetic heart valve thereto, said mounting member being an annular member having a central opening for receiving at least part of the prosthetic heart valve, wherein the prosthetic heart valve contains movable elements; a pulsatile pump, having an inlet and an outlet, wherein the pump outlet is fluidly connected to the inlet of the pulse chamber pressure vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber pressure vessel; and
,a drip collection chamber vessel having an inlet and an outlet, the drip collection chamber vessel in fluid communication with each prosthetic heart valve to collect paravalvular leakage. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of measuring paravalvular leakage from a prosthetic heart valve, comprising:
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providing a prosthetic heart valve, said prosthetic heart valve having a peripheral sewing ring, a frame and moveable elements; providing a paravalvular leak tester, the leak tester comprising; a pulse chamber pressure vessel having a top, a bottom, at least one side, an interior volume, an inlet and an outlet; at least one valve mounting opening in the bottom of the pulse chamber pressure vessel, the mounting member in fluid communication with the interior volume; a flexible valve ring mounting member mounted about each valve mounting opening for mounting the sewing ring of the prosthetic heart valve thereto, said mounting member being an annular member having a central opening for receiving at least part of the prosthetic heart valve; a pulsatile pump, having an inlet and an outlet, wherein the pump outlet is fluidly connected to the inlet of the pulse chamber pressure vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber vessel; and
,a drip collection chamber pressure vessel having an inlet and an outlet, the drip collection chamber pressure vessel in fluid communication with each prosthetic heart valve to collect paravalvular leakage. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of measuring paravalvular leakage from a prosthetic heart valve, comprising:
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providing a prosthetic heart valve, said heart valve having a peripheral sewing ring, a frame and moveable elements; providing a paravalvular leak tester, the leak tester comprising; a pulse chamber pressure vessel having a top, a bottom, at least one side, an interior volume, an inlet and an outlet; at least one valve mounting opening in the bottom of the pulse chamber pressure vessel, the valve mounting opening in fluid communication with the interior volume; a flexible valve ring mounting member mounted about each valve mounting opening for mounting a sewing ring of a prosthetic heart valve thereto, said mounting member being an annular member having a central opening for receiving at least part of the prosthetic heart valve; a pulsatile pump, having an inlet and an outlet, wherein the pump outlet is fluidly connected to the inlet of the pulse chamber pressure vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber vessel; and
,a drip collection chamber pressure vessel having an inlet and an outlet, the drip collection chamber pressure vessel in fluid communication with each prosthetic heart valve to collect paravalvular leakage; mounting the sewing ring of the prosthetic heart valve to the mounting member using at least one mechanical fixation device, such that the moveable elements are restrained from movement, and fluid is blocked from moving through the frame; filling the apparatus with a fluid; engaging the pulsatile pump to cause pressurized fluid to flow cyclically into the pulse chamber pressure vessel; and
,measuring paravalvular leakage flowing out from the prosthetic heart valve.
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Specification