Percutaneously deployed vascular valves

• US 20070027518A1
• Filed: 04/01/2004
• Published: 02/01/2007
• Est. Priority Date: 04/01/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Flagle, Jacob, Agnew, Charles, Case, Brian
• Granted Patent: US 7,871,434 B2
• Time in Patent Office: Days
• US Class Current: 623/1.100
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

Described are percutaneous vascular valves (11) free of attached support structures and deployment systems (31) and methods for providing attachment of the valves within a vascular vessel.

Claims

1. A percutaneous vascular valve, comprising:

a stentless vascular valve body having at least one flexible member for restricting blood flow, the flexible member having an edge for contacting a wall of a vascular vessel;

said edge adapted to attach to said wall.

2. The valve of claim 1, wherein said edge includes barbs.

3. The valve of claim 1, wherein said edge includes an adhesive.

4. The valve of claim 1, wherein said flexible member comprises a remodelable material.

5. The valve of claim 1, wherein said flexible member comprises a collagenous material.

6. The valve of claim 5, wherein said collagenous material comprises an extracellular matrix.

7. The valve of claim 6, wherein the extracellular matrix comprises submucosa.

8. The valve of claim 1, wherein the stentless vascular valve body comprises at least two leaflets.

9. The valve of claim 1, wherein said edge is configured to extend longitudinally along and at least partially circumferentially around the vessel wall.

10. The valve of claim 1, wherein said edge is a reinforced edge.

11. The valve of claim 10, wherein said reinforced edge has a thickness greater than a central portion of said flexible member.

24. A medical device, comprising a valve of claim 1, in combination with a percutaneous deployment device.

12. A percutaneous vascular valve and delivery system, comprising:

a stentless vascular valve body having at least one flexible member for restricting blood flow, the flexible member having an edge for attachment to a wall of a vascular vessel;

a percutaneous deployment device, the deployment device having an expandable element for selectively forcing said edge against the wall.

13. The valve and delivery system of claim 12, wherein said edge has a plurality of structural elements for attaching to said wall.

14. The valve and delivery system of claim 13, wherein said structural elements include barbs.

15. The valve and delivery system of claim 12, wherein said edge includes an adhesive.

16. The valve and delivery system of claim 12, wherein said expandable element comprises a wire frame.

17. The valve and delivery system of claim 12, wherein said stentless valve body comprises a remodelable material.

18. The valve and delivery system of claim 17, wherein said remodelable material is collagenous.

19. The valve and delivery system of claim 12, wherein the stentless valve body is releasably attached to the expandable element.

20. The valve and delivery system of claim 19, wherein the stentless valve body is releasably attached to the expandable element with an adhesive.

21. The valve and delivery system of claim 19, wherein the stentless valve body is releasably attached to the expandable element with a removable component.

22. The valve and delivery system of claim 21, wherein the removable component comprises a removable suture.

23. The valve and delivery system of claim 19, wherein the stentless valve body is releasably attached to the expandable element by an attachment adaptation on said body, said element, or both.

25. The medical device of claim 19, wherein said percutaneous deployment device has at least one expandable element for forcing said edge of said valve against a vessel wall.

26. A method for modifying blood flow in a vascular vessel, the method comprising:

percutaneously delivering one or more pieces of flexible material to a site within a vascular vessel; and

percutaneously attaching at least portions of said one or more pieces of flexible material to walls of the vascular vessel so as to form a structure that selectively permits blood flow in a first direction and resists blood flow in a second direction.

27. The method of claim 26, wherein said flexible material has remodelable properties.

28. The method of claim 26, wherein said flexible material contains collagen.

29. The method of claim 26, wherein said flexible material comprises an extracellular matrix material.

30. The method of claim 29, wherein said extracellualar matrix material contains collagen.

31. The method of claim 30, wherein said extracellular matrix material comprises submucosa.

32. The method of claim 26, wherein said structure includes a valve having two or more leaflets.

33. The method of claim 26, wherein said flexible material comprises collagen, and wherein said percutaneously attaching includes delivering energy to facilitate attachment of said portions to the wall.

34. The method of claim 33, wherein said energy includes electromagnetic radiation.

35. The method of claim 34, wherein said energy is selected from microwave, radio frequency, laser, and ultraviolet light energy.

36. The method of claim 33, wherein an energy-absorbing substance is provided in contact with said portions, and wherein said energy activates the energy-absorbing substance to attach said portions to the wall.

37. The method of claim 33, wherein the energy welds said portions to the wall.

38. The method of claim 26, wherein said percutaneously delivering comprises deploying the flexible material from a lumen of a percutaneously advancable device.

39. The method of claim 38, wherein said percutaneously delivering comprises deploying a delivery structure from the lumen, the delivery structure including the flexible material releasably held to an expandable element.

40. The method of claim 39, wherein the expandable element includes a balloon.

41. The method of claim 38, wherein the expandable element includes a wire structure.

42. The method of claim 26, wherein said attaching includes attaching a band of said flexible material in a path extending at least partially longitudinally and at least partially circumferentially along the wall.

43. A percutaneous vascular valve, comprising:

a vascular valve body free of any support structure and having at least one movable member for restricting blood flow, the movable member having an edge for contacting a wall of a vascular vessel;

said edge adapted to attach to said wall.