Proof testing of mechanical heart valves

• US 6,062,075 A
• Filed: 12/30/1998
• Issued: 05/16/2000
• Est. Priority Date: 12/30/1998
• Status: Expired due to Term

• Current Assignee: Valve Special Purpose Co. LLC (Cryolife Incorporated)
• Original Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Inventors: Ritz, Joseph P., Ely, John L., Haubold, Axel D.
• Primary Examiner(s): Kwok, Helen C.
• Application Number:
  US09/224,816
• Time in Patent Office: 503 Days
• Field of Search: 73/1.72, 73/168, 73/37, 73/46, 73/49.4, 73/49.8, 73/865.6, 623/2, 623/3, 623/11, 623/12, 607/33, 607/119
• US Class Current: 73/168
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: G01M 99/007 by applying a load, e.g. for resistance or wear testing G01M99/001 takes precedence; testing the elasticity of structures G01M5/00

Abstract

A method and apparatus for proof testing an assembled mechanical heart valve prosthesis having a valve body and at least one movable occluder wherein at least one of the components has a surface of nonmetallic crystalline material, such as pyrocarbon, in which microcrack growth may occur. The assembled valve prosthesis is subjected to fluid loading with the occluder in the closed position so as to create omnidirectional pressure of at least 20 psig therewithin on the downstream side of the occluder. During fluid loading of the assembled valve, acoustic monitoring is carried out using a transducer to detect sounds that are indicative of crack nucleation and/or incremental crack extension, based upon a predetermined fail-pass criterion. Any valve prosthesis wherein sounds of a greater magnitude are detected is rejected.

Claims

1. A method of proof testing an assembled mechanical heart valve prosthesis having a valve body and at least one movable occluder, at least one of which has a pyrocarbon surface in which micro crack growth may occur, which method comprises:

subjecting the assembled valve prosthesis to loading, with the at least one occluder in the closed position, so as to exceed normal service loading on a downstream side of the occluder,

acoustically monitoring the valve prosthesis during such loading to detect sounds by measuring transduced voltage signals for such signals whose energy feature exceeds a predetermined acoustic energy level so as to be indicative of crack nucleation and/or incremental crack extension, and

rejecting a valve prosthesis where such sounds are detected.

2. The method according to claim 1 wherein said loading is by fluid-loading so as to create omnidirectional pressure within a downstream region of the valve body.

3. The method according to claim 2 wherein said fluid-loading creates a pressure of at least about 10 psig therewithin.

4. The method according to claim 2 wherein said fluid-loading is carried out by pneumatically pressurizing a flexible bladder.

5. The method according to claim 4 wherein said fluid-loading is carried out by raising the pressure within said bladder from atmospheric pressure to at least about 25 psig over a time period of at least about 4 seconds.

6. The method according to claim 1 wherein said monitoring includes coupling a waveguide with an exterior surface of said valve body, said waveguide being adapted to conduct sound having a broadband wavelength between about 10 kiloHertz and about 1 megaHertz to an associated piezoelectric sensor.

7. The method according to claim 6 wherein said coupling step includes inserting a couplant material between said exterior surface of said valve body and a juxtaposed surface of said waveguide.

8. The method according to claim 6 wherein acoustic emissions from the assembled valve prosthesis are monitored for voltage signals from said piezoelectric sensor whose amplitude feature exceeds a predetermined amplitude.

9. A method of proof testing an assembled mechanical heart valve prosthesis having a pyrocarbon valve body and at least one pyrocarbon movable occluder, which method comprises:

subjecting the assembled valve prosthesis to fluid-loading with the at least one occluder in the closed position so as to create omnidirectional pressure of at least about 10 psig therewithin on a downstream side of the occluder,

acoustically monitoring the valve prosthesis during such fluid-loading by directly or indirectly coupling the valve body with a transducer that includes a piezoelectric element so as to detect broadband wavelength sounds, and

rejecting a valve prosthesis where sounds are detected in the form of voltage signals whose amplitude feature exceeds a predetermined amplitude that is indicative of crack nucleation and/or incremental crack extension in pyrocarbon.

18. The method according to claim 9 wherein said acoustically monitoring is carried out for sound having a wavelength between about 80 kHz and about 800 kHz.

19. The method according to claim 18 wherein said monitoring is carried out so as to detect any voltage signal having an amplitude exceeding about 70 acoustic emission decibels and rejecting a valve prosthesis where a voltage signal having at least such amplitude is detected.

10. Apparatus for proof testing an assembled mechanical heart valve prosthesis having a valve body and at least one movable occluder, at least one of which assembled components has a surface that is formed of a material in which microcrack growth may occur, which apparatus comprises:

a fixture for holding the valve body of the assembled valve prosthesis with the at least one movable occluder in the closed position,

acoustic sensing means which includes a waveguide and transducer means that are adapted to detect sound emitted from said assembled components and generate a responsive electrical signal,

spring-biasing means connected to said waveguide which causes said waveguide to seat in close contact with an exterior surface of the valve body being tested,

means for fluid-loading an interior region of said assembled valve prosthesis at a location downstream of said closed occluder so as to apply omnidirectional pressure therewithin of at least about 10 psig, and

means for monitoring output signals from said transducer means during fluid-loading of said interior region of the valve prosthesis to detect signals resulting from sounds being emitted that are indicative of crack nucleation and/or incremental crack extension in the assembled valve prosthesis.

11. The apparatus according to claim 10 wherein said fluid-loading means includes a flexible, extensible bladder and means for pneumatically pressurizing said flexible bladder.

12. The apparatus according to claim 11 wherein said fluid-loading means further includes means for raising said pneumatic pressure within said flexible bladder in a programmed manner over time.

13. The apparatus according to claim 10 wherein said transducer means includes a piezoelectric element.

14. The apparatus according to claim 13 wherein said monitoring means includes means for measuring voltage signals generated by said transducer means.

15. The apparatus according to claim 14 wherein said monitoring means includes means for measuring voltage signals corresponding to the energy generated by acoustic emissions from the assembled valve prosthesis.

16. The apparatus according to claim 10 which includes a plurality of interchangeable cups, wherein said fixture is adapted to receive said interchangeable cups which are sized to support valves having generally tubular pyrolytic carbon valve bodies with exterior diameters of different sizes in an orientation for proof testing and wherein said fluid-loading means is adapted to provide omnidirectional pressure within the interior region of the valve body of at least about 25 psig while the valve body is supported in one of said interchangeable cups.

17. The apparatus according to claim 16 wherein said fixture includes means for ejecting said generally tubular valve body from said one of said interchangeable cups in an axial direction.

20. The apparatus according to claim 13 wherein a pair of diametrically opposed waveguides are provided which are spring-biased to contact diametrically opposite regions of the exterior surface of a tubular valve body.