Prosthetic valve and method for making same

• US 7,547,322 B2
• Filed: 06/29/2004
• Issued: 06/16/2009
• Est. Priority Date: 07/19/2001
• Status: Expired due to Term

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Sarac, Timur Paul, Smedira, Nicholas G.
• Primary Examiner(s): Willse; David H
• Assistant Examiner(s): Blanco; Javier G
• Application Number:
  US10/880,043
• Publication Number:
  US 20040260390A1
• Time in Patent Office: 1,813 Days
• Field of Search: 623/1.13, 623 124- 126, 623 211- 218, 623/900, 623/925, 606/194
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

Abstract

A prosthetic valve for placement within a body passage includes at least two valve leaflets made from a first layer of either peritoneal fascia tissue or pleural tissue. Support structure is attached to the first layer to provide structural support for the valve leaflets. A method for producing the prosthetic valve is also provided.

Claims

1. A prosthetic valve for placement within a body passage, said prosthetic valve comprising:

at least two semi-elliptical valve leaflets made from a first layer of biological material selected from a group consisting of peritoneal fascia tissue and pleural tissue, each of said at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by a free edge, the free edge having a convex shape when the valve leaflets are in a flat configuration;

support means attached to said first layer to provide structural support for said at least two valve leaflets, said support means including an expandable stent having inner and outer surfaces and further including a strut member located at each of at least two commissural sides formed by the junctions of adjoining lateral sides of said at least two valve leaflets; and

a second layer of biological material attached to said inner surface of said stent, said second layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue, and said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow, said at least two valve leaflets extending across said conduit.

2. The prosthetic valve of claim 1 wherein said second layer of biological material comprises a serous membrane.

3. The prosthetic valve of claim 2 wherein said first layer of biological material comprises a serous membrane

4. The prosthetic valve of claim 2 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

5. The prosthetic valve of claim 1 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

6. The prosthetic valve of claim 1 wherein said first layer of biological material comprises a serous membrane.

7. The prosthetic valve of claim 1 wherein said support means comprises an expandable stent.

8. The prosthetic valve of claim 7 further comprising a second layer of biological material attached to said stent, said second layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

9. The prosthetic valve of claim 8 wherein said second layer of biological material comprises a serous membrane.

10. The prosthetic valve of claim 9 wherein said first layer of biological material comprises a serous membrane.

11. The prosthetic valve of claim 9 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

12. The prosthetic valve of claim 8 wherein said second layer extends along the entire length of said stent and forms a tubular conduit inside said stent.

13. The prosthetic valve of claim 1 wherein said lateral sides of each of said at least two valve leaflets adjoin each other and are attached to each other to form at least two commissural sides that are separated by said free edges, said free edges being coaptable to permit unidirectional flow of blood through the body passage.

14. A prosthetic valve for placement within a body passage to permit unidirectional flow of blood through the body passage, said prosthetic valve comprising:

at least two semi-elliptical valve leaflets made of a first layer of biological material selected from a group consisting of peritoneal fascia tissue and pleural tissue, each of said at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by a free edge, the free edge having a convex shape when the valve leaflets are in a flat configuration;

support means attached to said first layer to provide structural support for said at least two valve leaflets, said support means including an expandable stent having cylindrical inner and outer surfaces and further including a strut member located at each of at least two commissural sides formed by the junctions of adjoining lateral sides of said at least two valve leaflets; and

a second layer of biological material attached to said support member, said second layer being selected from a group consisting of peritoneal fascia tissue and pleural tissue, said second layer including a radially inwardly facing surface that defines a conduit for directing blood flow, said second layer being attached to said cylindrical inner surface of said stent;

said at least two valve leaflets extending across said conduit to permit unidirectional flow of blood through the body passage.

15. The prosthetic valve of claim 14 wherein said second layer of biological material comprises a serous membrane.

16. The prosthetic valve of claim 15 wherein said first layer of biological material comprises a serous membrane.

17. The prosthetic valve of claim 15 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

18. The prosthetic valve of claim 14 wherein said first layer of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

19. The prosthetic valve of claim 14 wherein said first layer of biological material comprises a serous membrane.

20. The prosthetic valve of claim 14 wherein said second layer extends along the entire length of said support member.

21. The prosthetic valve of claim 14 wherein said lateral sides of each of said at least two valve leaflets adjoin each other and are attached to each other to form at least two commissural sides that are separated by said free edges, said free edges being coaptable to permit unidirectional flow of blood through the body passage.

22. A prosthetic valve for placement within a body passage, said prosthetic valve comprising:

a first sheet of biological material selected from a group consisting of peritoneal fascia tissue and pleural tissue, said first sheet being trimmed to form at least two semi-elliptical valve leaflets, each of said at least two valve leaflets having an oppositely disposed pair of lateral sides spaced apart by free edge, the free edge having a convex shape when the valve leaflets are in a flat configuration;

said lateral sides of each of said at least two valve leaflets adjoining each other and being attached to each other to form an oppositely disposed pair of commissural sides separated by said free edges that are coaptable to permit unidirectional flow of blood through the body passage;

support means attached to said first sheet to provide structural support for said at least two valve leaflets, said support means including an expandable stent having cylindrical inner and outer surfaces and further including a strut member located at each of at least two commissural sides formed by the junctions of adjoining lateral sides of said at least two valve leaflets; and

a second sheet of biological material attached to said inner surface of said stent, said second sheet being selected from a group consisting of peritoneal fascia tissue and pleural tissue and said second sheet of biological material including a radially inwardly facing surface that defines a conduit for directing blood flow, said at least two valve leaflets extending across said conduit.

23. The prosthetic valve of claim 22 wherein said second sheet of biological material comprises a serous membrane.

24. The prosthetic valve of claim 23 wherein said first sheet of biological material comprises a serous membrane.

25. The prosthetic valve of claim 23 wherein said first sheet of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

26. The prosthetic valve of claim 22 wherein said first sheet of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

27. The prosthetic valve of claim 22 wherein said first sheet of biological material comprises a serous membrane.

28. The prosthetic valve of claim 22 wherein said support means comprises an expandable stent.

29. The prosthetic valve of claim 28, further comprising a second sheet of biological material attached to said stent, said second sheet being selected from a group consisting of peritoneal fascia tissue and pleural tissue.

30. The prosthetic valve of claim 29 wherein said second sheet of biological material comprises a serous membrane.

31. The prosthetic valve of claim 30 wherein said first sheet of biological material comprises a serous membrane.

32. The prosthetic valve of claim 30 wherein said first sheet of biological material comprises an inner lining of a serous membrane and an outer lining of fascia.

33. The prosthetic valve of claim 29 wherein said second sheet extends along the entire length of said stent and forms a tubular conduit inside said stent.