Paravalvular Leak Test Apparatus and Method

• US 20100154507A1
• Filed: 12/18/2008
• Published: 06/24/2010
• Est. Priority Date: 12/18/2008
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Matonick, John P.
• Granted Patent: US 8,230,717 B2
• Time in Patent Office: Days
• US Class Current: 73/1.720
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: Y10S 623/912 Method or apparatus for measuring or testing prosthetic
• CPC Class Codes: Y10S 623/913 Heart

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.

Claims

2. The apparatus of claim 1, wherein the pulsatile pump comprises controls for adjusting stroke volume, discharge pressure, and cyclic rate.

5-1. The apparatus of claim 1 additionally comprising a heater and a temperature controller mounted to the fluid reservoir for controlling the temperature of a circulating fluid in the apparatus.

10. 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;

11. The method of claim 10, wherein the pulsatile pump comprises controls for adjusting stroke volume, discharge pressure, and cyclic rate.

12. The method of claim 10, wherein the pulsatile pump is a piston pump.

13. The method of claim 10, additionally comprising a fixture for receiving a prosthetic heart valve and for constraining the moveable elements of the heart valve.

14. The method of claim 10 additionally comprising a fluid reservoir, said fluid reservoir in fluid communication with the outlet of the drip chamber, the outlet of the pulse chamber vessel, and the inlet of the pulsatile pump.

15. The method of claim 10 additionally comprising a heater and a temperature controller mounted to the fluid reservoir for controlling the temperature of a circulating fluid in the apparatus.

16. The method of claim 15, additionally comprising a return pump, the return pump having an inlet in fluid communication with the outlet of the drip collection vessel, and an outlet in fluid communication with the inlet of the fluid reservoir.

17. The method of claim 10 additionally comprising a temperature transducer and a pressure transducer mounted to the pulse chamber for detecting the temperature and pressure of fluid in the pulse chamber pressure vessel.

18. The method of claim 10, wherein the drip collection chamber vessel comprises at least one separate collection compartment for each prosthetic heart valve

19. The method of claim 18, additionally comprising a flow meter connected to each compartment.

10-2. 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.