Prosthetic valve devices and methods of making such devices

• US 20050027348A1
• Filed: 07/30/2004
• Published: 02/03/2005
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A.
• Granted Patent: US 7,153,324 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

Prosthetic valve devices for implantation in body vessels, and methods of making same, are provided. The device has a main body with first and second ends and defining a lumen, with the second end being inverted into the lumen. A valve is disposed at the second end. In multiple valve devices, valves are disposed at the first and second ends, and individually may be inverted into the lumen. The prosthetic valve devices may further include a support structure such as a stent. Methods of making a prosthetic valve device include providing a main body having first and second ends and defining a lumen, forming a valve at the second end, and inverting the second end into the lumen. Methods may further comprise forming multiple valves and may also include attaching a support structure.

Claims

1. A prosthetic valve device for implantation in a body vessel, comprising:

a main body having first and second ends and defining a lumen, the second end being inverted into the lumen; and

a valve disposed at the second end, the valve adapted to permit fluid flow through the lumen in a first direction and substantially prevent fluid flow through the lumen in a second, opposite direction.

2. The device of claim 1 wherein the main body comprises an extracellular matrix.

3. The device of claim 1 wherein the main body comprises submucosa.

4. The device of claim 1 wherein the main body comprises a synthetic material.

5. The device of claim 1 wherein the main body comprises a polymeric material.

6. The device of claim 1 further comprising a support structure adapted to provide support to the main body, the support structure having proximal and distal ends.

7. The device of claim 6 wherein the valve is positioned axially between the proximal and distal ends of the support structure.

8. The device of claim 6 wherein the valve is axially positioned external to the distal end of the main body.

9. The device of claim 1 wherein the valve comprises an opening that permits a controlled amount of fluid flow through the lumen in the second, opposite direction.

10. The device of claim 1 further comprising an anchor point attaching the valve and the main body.

11. The device of claim 1 wherein the valve has an orifice with an inner diameter and the main body lumen has an inner diameter, and wherein the valve orifice inner diameter is smaller than the inner diameter of the main body lumen.

12. A prosthetic valve device for implantation in a body vessel, comprising:

a main body having first and second ends and defining a lumen, the second end being inverted into the lumen; and

a first valve disposed at the first end and a second valve disposed at the second end, the first and second valves individually adapted to permit fluid flow through the lumen in a first direction and substantially prevent fluid flow through the lumen in a second, opposite direction.

13. The device of claim 12 wherein the main body comprises an extracellular matrix.

14. The device of claim 12 wherein the main body comprises submucosa.

15. The device of claim 12 further comprising a support structure adapted to provide support to the main body, the support structure having proximal and distal ends.

16. The device of claim 12 wherein one of the first and second valves is axially positioned between the proximal and distal ends of the support structure.

17. The device of claim 12 wherein one of the first and second valves is axially positioned at or near the distal end of the support structure.

18. The device of claim 12 wherein the first and second valves are substantially in line.

19. The device of claim 12 wherein the first and second valves are angularly offset.

20. The device of claim 12 wherein one of the first and second valves comprises an opening that permits a controlled amount of fluid flow through the lumen in the second, opposite direction.

21. The device of claim 12 further comprising an anchor point attaching one of the first and second valves and the main body.

22. The device of claim 12 wherein the valve has an orifice with an inner diameter and the main body lumen has an inner diameter, and wherein the valve orifice inner diameter is smaller than the inner diameter of the main body lumen.

23. A prosthetic valve device for implantation in a body vessel, comprising:

a tubular main body having first and second ends and defining a lumen;

a valve disposed at the second end, the valve adapted to permit fluid flow through the lumen in a first direction and substantially prevent fluid flow through the lumen in a second, opposite direction; and

a support structure having proximal and distal ends, the proximal end disposed in the lumen of the main body, the second end of the main body inverted into the lumen and enveloping the proximal end of the support structure.

24. The device of claim 23 wherein said prosthetic valve device comprises a prosthetic venous valve.

25. A method of making a prosthetic valve device, comprising:

providing a main body having first and second ends and defining a lumen; and

inverting the second end into the lumen to form a valve.

26. A method of making a prosthetic valve device, comprising:

providing a main body sheet having first and second edges; and

inverting the main body intermediate the first and second edges to form a tubular body having first and second ends and defining a lumen and a valve.

27. A method of claim 26 further comprising joining the main body sheet to form the tubular body.

28. A method of making a prosthetic valve device, comprising:

providing a main body having first and second ends and defining a lumen;

forming a valve at the second end; and

inverting the second end into the lumen.

29. The method of claim 28 further comprising disposing the main body adjacent to a support structure having proximal and distal ends.

30. The method of claim 29 further comprising axially positioning the valve between the proximal and distal ends of the support structure.

31. The method of claim 29 further comprising axially positioning the valve positioned at or near the distal end of the support structure.

32. The method of claim 28 further comprising forming a second valve at the first end of the main body.

33. The method of claim 32 further comprising disposing the second valve substantially in line to the first valve.

34. The method of claim 32 further comprising disposing the second valve offset to the first valve.

35. A method of making a prosthetic valve device, comprising the steps of:

providing a tubular main body having first and second ends and defining a lumen;

providing a support structure having proximal and distal ends;

forming a valve at the second end of the main body;

disposing the proximal end of the support structure in the lumen of the main body; and

inverting the second end of the main body to the lumen and enveloping the proximal end of the support structure.