Trileaflet Heart Valve

• US 20070118210A1
• Filed: 11/17/2006
• Published: 05/24/2007
• Est. Priority Date: 11/18/2005
• Status: Abandoned Application

• Current Assignee: Innovia LLC
• Original Assignee: Innovia LLC
• Inventors: Pinchuk, Leonard
• Application Number:
  US11/561,069
• Publication Number:
  US 20070118210A1
• Time in Patent Office: Days
• US Class Current: 623/1.260
• 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: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 53/02 of vinyl-aromatic monomers and conjugated dienes
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence

Abstract

A prosthetic heart valve is described that includes three leaflet members which open and close in unison with the flowing of blood through the aorta. The leaflets are made of a composite multilayer polymer material that includes a central porous material such as polyethylene terephthalate sandwiched between two other polymer layers. The two polymer layers are made up of block co-polymers that contain polyisobutylene. The composite multilayer may be formed by dip coating the porous material into a solution of the block co-polymer or by compression molding of the porous material between two layers of the block co-polymer. The composite multilayer polymer material is biocompatible and durable in bodily implant applications.

Claims

1. A prosthetic heart valve, comprising:

a plurality of flexible members defining a prosthetic valve aperture adapted to open and close in response to a flow of blood produced by a heart, said plurality of flexible members including a first layer of a polymeric material, a second layer of the polymeric material, and a central porous polymeric membrane sandwiched between the first layer and the second layer.

2. The prosthetic heart valve of claim 1, wherein:

the polymeric material includes a block copolymer.

3. The prosthetic heart valve of claim 2, wherein:

the block copolymer includes polyisobutylene.

4. The prosthetic heart valve of claim 2, wherein:

the block copolymer includes block units of polystyrene-polyisobutylene-polystyrene.

5. The prosthetic heart valve of claim 4, wherein:

the central porous polymeric membrane is dip-coated into a solution of the polymeric material.

6. The prosthetic heart valve of claim 4, wherein:

the central porous polymeric membrane includes polyethylene terephthalate.

7. The prosthetic heart valve of claim 4, wherein:

the central porous polymeric membrane includes a compound selected from the group consisting of silicone rubber, polyurethane, polyolefin, nylon, expanded polyfluoroethylene, and combinations thereof.

8. The prosthetic heart valve of claim 4, wherein:

the plurality of flexible members includes three flexible members supported by a support structure, the support structure having a base and three struts that extend substantially vertically from the base.

9. The prosthetic heart valve of claim 8, wherein:

the support structure is substantially annular.

10. The prosthetic heart valve of claim 8, wherein:

the support structure includes a cuff for affixing the prosthetic heart valve to a vascular implant site.

11. The prosthetic heart valve of claim 8, wherein:

the support structure includes polyisobutylene.

12. The prosthetic heart valve of claim 1, wherein:

the prosthetic heart valve is collapsible in the radial direction.

13. The prosthetic heart valve of claim 1, further comprising:

at least one antithrombogenic agent loaded into the prosthetic heart valve.

14. The prosthetic heart valve of claim 1, further comprising:

at least one tissue growth agent loaded into the prosthetic heart valve.

15. The prosthetic heart valve of claim 1, wherein:

the central porous polymeric membrane is a polymeric fabric.

16. The prosthetic heart valve of claim 15, wherein:

said polymeric fabric includes polyethylene terephthalate.

17. The prosthetic heart valve of claim 16, wherein:

a composite multilayer polymeric membrane is formed by compression molding whereby the polymeric fabric is sandwiched between two outer polymeric layers.

18. The prosthetic heart valve of claim 17, wherein:

the compression molding partially presses the two outer polymeric layers through the polymeric fabric.

19. The prosthetic heart valve of claim 17, wherein:

the compression molding is adapted such that there is a plane of the polymeric fabric not physically integrated with the two outer polymeric layers.

20. The prosthetic heart valve of claim 1, wherein:

the plurality of members are loaded with at least one antithrombogenic agent.

21. The prosthetic heart valve of claim 1, wherein:

the plurality of members are loaded with at least one tissue growth agent.

22. The prosthetic heart valve of claim of 8, wherein:

sutures join the three flexible members to the support structure.

23. The prosthetic heart valve of claim of claim 22, wherein:

a cuff surrounds a bottom portion of the support structure, the cuff for affixing the prosthetic heart valve to a wall of a vascular implant site.

24. The prosthetic heart valve of claim of claim 23, wherein:

the cuff can be loaded with therapeutic agents.

25. A prosthetic heart valve, comprising:

a plurality of flexible members defining a prosthetic valve aperture adapted to open and close in response to a flow of blood produced by a heart, each flexible member including a polymeric composite, the polymeric composite including a polymeric fabric and two outer polymeric layers wherein the polymeric fabric is surrounded by the two outer polymeric layers, the two outer polymeric layers forming a coating on said polymeric fabric.

26. The composite multilayer polymeric material of claim 25, wherein:

the coating is made by compression molding of the polymeric fabric between the two outer polymeric layers.

27. The composite multilayer polymeric material of claim 25, wherein:

the coating is made by dip coating the polymeric fabric into a solution of a block copolymer material.

28. A method for manufacturing a prosthetic valve comprising the steps of:

a) providing a tubular polymeric structure having a top portion, a bottom portion, and defining a central axis, the top portion realized from a composite including an intermediate porous polymeric fabric disposed between two or more outer polymeric layers;

b) inserting the polymeric structure through a stent support structure, the stent support structure having a plurality of struts, the struts projecting substantially parallel to the central axis of the tubular structure;

c) forming a plurality of leaflet members from the top portion of the cylindrical polymeric structure;

d) suturing the leaflet members to the stent support structure; and

e) folding a bottom portion of the tubular polymeric structure upon itself to form an anchoring cuff.

29. The method of claim 28, wherein:

the intermediate porous polymeric fabric comprises polyethylene terephthalate and the outer polymeric layers comprise polyisobutylene.

30. The method of claim 29, wherein:

the outer polymeric layers comprise a block copolymer of polystyrene-polyisobutylene-polystyrene.

31. The method of claim 28, wherein:

the intermediate porous fabric is compression molded between the outer polymeric layers.

32. The method of claim 28, wherein:

the intermediate porous polymeric fabric is dip-coated between the outer polymeric layers.