Tri-composite, full root, stentless valve

• US 6,797,000 B2
• Filed: 01/18/2002
• Issued: 09/28/2004
• Est. Priority Date: 01/27/1999
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Simpson, Charles L., OʼConnor, Lisa G., Westaby, Stephen, McIlroy, Brian K., Casagrande, Ivan
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): Barrett, Thomas C.
• Application Number:
  US10/051,216
• Publication Number:
  US 20020116053A1
• Time in Patent Office: 984 Days
• Field of Search: 623/2--, 623/2.42
• US Class Current: 623/2.15
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/91 Heart

Abstract

A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Claims

1. A prosthetic composite heart valve, comprising three mammalian heart valve leaflet sections, each leaflet section comprising a full root length of tissue and a valve leaflet, the leaflet sections being coupled to one another by hidden stitching and locking stitching to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets.

2. The prosthetic heart valve of claim 1, wherein the stitching includes thread of a first color indicating a trimming area and thread of a second color indicating a non-trimming area.

3. The prosthetic heart valve of claim 1, wherein the hidden stitching indicates an area that may not be trimmed.

4. The prosthetic heart valve of claim 1, wherein the hidden stitching includes a suture that will not unravel when cut.

5. The prosthetic heart valve of claim 1, wherein the locking stitching indicates an area that may be trimmed.

6. The prosthetic heart valve of claim 1, wherein the locking stitching is also hidden stitching.

16. The prosthetic heart valve of claim 1, wherein said predefined is a distance in the range of from 1 centimeter to 15 centimeters.

7. A stentless prosthetic heart valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another by hidden stitching and locking stitching, wherein each of said leaflet sections comprises a full root length of tissue, and wherein said hill root length of tissue for at least one of said leaflet sections extends from a predefined firs;

distance below an annulus defined by the valve leaflets in the fluid flow passage to a predefined second distance above the sinotubular junction of the aorta.

8. The prosthetic heart valve of claim 7, wherein said predefined first distance is a distance in the range of from one to three centimeters.

9. The prosthetic heart valve of claim 7, wherein said predefined second distance is a distance in the range of from one to three centimeters.

10. A stenless prosthetic heart valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another hidden stitching and locking stitching, and a pericardial covering on at least one of the inflow end and the outflow end thereof.

11. The prosthetic heart valve of claim 10, wherein the pericardium covering comprises a mammalian pericardium.

12. The prosthetic heart valve of claim 11, wherein the pericardium covering is sutured to the valve using hidden stitching.

13. The prosthetic heart valve of claim 11, wherein the pericardium covering is sutured to the valve using locking stitching.

14. The prosthetic heart valve of claim 11, wherein the pence turn covering extends a predefined distance from an end of the valve along the length thereof.

15. The prosthetic heart valve of claim 11, wherein the pericardium covering contains a stitch which facilitates surgeon suture placement by indicating where sutures can be placed without damaging the leaflets.

17. A stentless prosthetic bean valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another by hidden stitching and locking stitching, wherein at least two of said valve leaflet sections are coupled together using a technique selected from the group consisting of adhesion and fusion.

18. A stentless prosthetic heart valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another by hidden stitching and locking stitching, wherein said stitching comprises suture material of a first color indicating a trimming area and suture material of a second color indicating a non-trimming area.

19. The prosthetic heart valve of claim 18, wherein the locking stitching is also hidden stitching.

20. A Stentless prosthetic heart valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another by hidden stitching and locking stitching, wherein the hidden and locking stitching sutures two valve leaflets together and the hidden stitching indicates an area that may not be trimmed.

21. A stentless prosthetic heart valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another by hidden stitching and locking stitching, wherein the hidden and locking stitching sutures two valve leaflets together and the hidden stitching includes a suture that will not unravel when cut.

22. A stentless prosthetic heart valve, comprising a plurality of mammalian bean valve leaflet sections coupled to one another by hidden stitching and locking stitching, wherein the hidden and locking stitching sutures two valve leaflets together and the locking stitching indicates an area that may be trimmed.

23. A stentless prosthetic heart valve, comprising a plurality of mammalian heart valve leaflet sections coupled to one another by hidden stitching and locking stitching and a pericardial covering on at least one of the inflow end and the outflow end thereof, wherein each of said leaflet sections comprises a flail root length of tissue, and wherein said full root length of tissue for at least one of said leaflet sections extends from a predefined first distance below an annulus defined by the valve leaflets in the fluid flow passage to a predefined second distance above the sinotubular junction of the aorta.