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US 2010/0154507 A1Published application
Paravalvular Leak Test Apparatus and Method
AssigneeEthicon, Inc.
InventorJohn P. Matonick
Life of this patent
Estimating the term…
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.
Claims21
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 mounting member 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 a 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 vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber vessel;
- and,
- a drip collection chamber vessel having an inlet and an outlet, the drip communication vessel in fluid communication with each heart valve to collect paravalvular leakage.
3 more elements
A method of measuring paravalvular leakage from a prosthetic heart valve, comprising:
- 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 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 a 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 vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber vessel;
- and,
- a drip collection chamber vessel having an inlet and an outlet, the drip communication vessel in fluid communication with each heart valve to collect paravalvular leakage;
- providing a prosthetic heart valve, said heart valve having a peripheral sewing ring, a frame and moveable elements;
5 more elements
A method of measuring paravalvular leakage from a prosthetic heart valve, comprising:
- 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 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 a 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 vessel, and the inlet of the pump is fluidly connected to the outlet of the pulse chamber vessel;
- and,
- a drip collection chamber vessel having an inlet and an outlet, the drip communication vessel in fluid communication with each heart valve to collect paravalvular leakage;
- providing a prosthetic heart valve, said heart valve having a peripheral sewing ring, a frame and moveable elements;
- mounting the sewing ring of the heart valve to the mounting member using at least one mechanical fixation device, and such that 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 heart valve.
10 more elements
Dependencies are inferred from the claim text.