Woven implantable device

• US 20060235511A1
• Filed: 04/12/2006
• Published: 10/19/2006
• Est. Priority Date: 02/09/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Osborne, Thomas A.
• Granted Patent: US 8,337,545 B2
• Time in Patent Office: Days
• US Class Current: 623/2.120
• 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, the valve comprising:

at least one flexible member formed at least partially from a woven layer, the woven layer comprising;

a first material; and

a second material, the first and second materials being at least partially woven together to form the layer;

wherein 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; and

wherein the 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 in 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 further comprising a third material at least partially woven together with the woven layer.

8. The prosthetic valve of claim 1 wherein the first material and the second material are at least partially woven together to form a non-uniform mesh.

9. The prosthetic valve of claim 1 further comprising an opening defined in the woven layer.

10. The prosthetic valve of claim 9, wherein the pair of flexible members forms a member contact area when the flow is in the second direction.

11. The prosthetic valve of claim 1, wherein at least a portion of the first material forms a structural feature, the structural feature extending beyond a perimeter of the woven layer for engaging a body vessel.

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

13. 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.

14. A method of making a prosthetic valve for implantation in a body vessel, the method comprising:

providing a first material, the first material being capable of forming a first, unexpanded configuration and a second, expanded configuration for a woven layer;

providing a second material;

weaving together at least a portion of the first material with the second material to form the woven layer; and

forming a valve device from the woven layer.

15. The method of claim 14 further comprising forming an opening in the woven layer.

16. The method of claim 14 wherein the first material provides a memory shape for the flexible member.

17. The method of claim 14 further comprising providing a support frame for the valve.

18. A method of implanting a prosthetic valve in a body vessel, the method comprising:

providing a prosthetic valve having at least one flexible member formed at least partially from a woven layer, the at least one flexible member being 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 woven layer comprising;

a first material; and

a second material, the first and second materials being at least partially woven together to form the layer;

delivering the prosthetic valve in a first unexpanded configuration through the body vessel to an implantation site; and

implanting the valve in a second, expanded configuration.

19. The method of claim 18 comprising providing a self-expanding valve.

20. The method of claim 18 comprising implanting the valve in the second, expanded configuration using a structural feature formed by a portion of the first material extending from a perimeter of the woven layer to hold the valve in position.