Woven implantable device

• US 8,337,545 B2
• Filed: 04/12/2006
• Issued: 12/25/2012
• Est. Priority Date: 02/09/2004
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Osborne, Thomas A.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/403,463
• Publication Number:
  US 20060235511A1
• Time in Patent Office: 2,449 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.38, 623/1.44, 623 149- 154
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A prosthetic valve device, a method for making a valve device, and a method for implanting a valve device into a recipient are provided. The valve device includes at least one flexible member formed at least partially from a woven layer. The woven layer includes a first material and a second material being at least partially woven together. The at least one flexible member is movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction. The valve has a first, unexpanded configuration and a second, expanded configuration.

Claims

1. A prosthetic valve for implantation in a body vessel, said prosthetic valve having a lengthwise axis and comprising:

at least one flexible member movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction, the at least one flexible member formed of a woven structure having a surface and an outer edge, the woven structure comprising a continuous weave of first and second materials forming the surface;

the first material including multiple fibers interwoven with the second material, wherein the multiple fibers extend from the continuous weave along the outer edge of the flexible member to form a structure perimeter formed only of the first material and defining the perimeter of the woven structure; and

a plurality of extensions formed of the first material, each extension of the plurality of extensions extending outward from the structure perimeter relative to said lengthwise axis of said prosthetic valve and adapted for engaging said body vessel;

wherein said prosthetic valve has a first, unexpanded configuration and a second, expanded configuration.

2. The prosthetic valve of claim 1, wherein the second material comprises a remodelable material.

3. The prosthetic valve of claim 1, wherein the second material comprises an extracellular matrix material (ECM).

4. The prosthetic valve of claim 1 wherein the second material comprises a synthetic material.

5. The prosthetic valve of claim 1 wherein the first material comprises a shape memory alloy.

6. The prosthetic valve of claim 5 wherein the shape memory alloy provides a memory shape for the flexible member in the expanded configuration.

7. The prosthetic valve of claim 1 wherein the woven structure comprises a continuous weave of first, second and third materials along the surface.

8. The prosthetic valve of claim 1 further comprising an opening defined in the woven structure.

9. The prosthetic valve of claim 8, wherein the at least one flexible member comprises a pair of flexible members;

and

wherein the pair of flexible members forms a member contact area when the flow is in the second direction.

10. The prosthetic valve of claim 1, further comprising a support structure operably connected to the at least one flexible member.

11. The prosthetic valve of claim 1, wherein the second material is provided as a sheet of material and the first material is at least partially woven into the sheet.

12. The prosthetic valve of claim 1, wherein the first material comprises a shape memory alloy and the second material comprises a remodelable material.

13. The prosthetic valve of claim 12, wherein the first material comprises a titanium nickel alloy.

14. The prosthetic valve of claim 12, wherein the second material comprises an extracellular matrix material (ECM).

15. The prosthetic valve of claim 14, wherein the ECM comprises small intestine submucosa (SIS).

16. The prosthetic valve of claim 12, wherein the first material comprises a titanium nickel alloy and the second material comprises an extracellular matrix material (ECM).

17. The prosthetic valve of claim 1, wherein the woven structure comprises a mesh formed from a uniform weave of the first material and the second material.

18. The prosthetic valve of claim 1, wherein the woven structure comprises a mesh formed from a non-uniform weave of the first material and the second material.