Woven implantable device

• US 9,066,798 B2
• Filed: 12/24/2012
• Issued: 06/30/2015
• 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:
  US13/726,264
• Publication Number:
  US 20130110254A1
• Time in Patent Office: 918 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.38, 623/1.44, 623 149- 154
• US Class Current: 1/1
• 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 method of making a prosthetic valve for implantation in a body vessel, the method comprising:

providing a first material comprising a metal, 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, the valve device having a leaflet formed of a portion of the woven layer having multiple filaments of the first material and the second material and 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.

2. The method of claim 1, wherein the first material comprises stainless steel.

3. The method of claim 1, wherein the first material comprises a shape memory alloy.

4. The method of claim 3, wherein the shape memory alloy comprises a titanium nickel alloy.

5. The method of claim 1, wherein the second material comprises a natural material.

6. The method of claim 5, wherein the second material comprises a resorbable material.

7. The method of claim 5, wherein the second material comprises a collagenous material.

8. The method of claim 7, wherein the second material is bioremodellable.

9. The method of claim 8, wherein the second material comprises an extracellular matrix material (ECM).

10. The method of claim 9, wherein the second material is selected from the group consisting of submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum, and basement membrane layer.

11. The method of claim 9, wherein the second material is selected from the group consisting of intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa.

12. The method of claim 9, wherein the second material comprises small intestine submucosa (SIS).

13. The method of claim 1, wherein the second material comprises a synthetic material.

14. The method of claim 1, wherein the first material is in the form of round rods having an outer diameter from about 0.0001 inches to about 0.250 inches.

15. The method of claim 1, further comprising subjecting the first and second materials to pressure to compress the second material.

16. The method of claim 1, wherein the valve device forms a perimeter;

and

wherein the perimeter is formed from the first material.

17. The method of claim 1, wherein the weaving together comprises weaving together the first material and the second material to form a uniform weave pattern.

18. The method of claim 1, wherein the weaving together comprises weaving together the first material and the second material to form a non-uniform weave pattern.

19. The method of claim 1, wherein the weaving together comprises weaving together the first material and the second material to form an irregular weave pattern.

20. The method of claim 1, wherein the valve device forms a perimeter;

and

wherein the perimeter comprises a greater percentage of the first material than of the second material.