Implantable vascular device

• US 20060142846A1
• Filed: 06/22/2005
• Published: 06/29/2006
• Est. Priority Date: 02/03/2000
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Bates, Brian L., Dixon, Christopher G., Hoffa, Andrew K., Osborne, Thomas A., Keller, Frederick S., Rosch, Josef, Obermiller, Joseph F., DeFord, John A., Leonard, Raymond B. II
• Granted Patent: US 7,520,894 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• 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 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Claims

1. A medical product, comprising:

a stentless valve having a plurality of membranes, the plurality of membranes implantable in a body lumen and movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen.

2. The medical product of claim 1, wherein said membranes are percutaneously implantable.

3. The medical product of claim 1, wherein said membranes are configured to flex in response to fluid flow in the body lumen.

4. The medical product of claim 1, wherein said membranes are configured to invert their shape in response to fluid flow in the body lumen.

5. The medical product of claim 1, also including one or more barbs configured to embed in the body lumen.

6. The medical product of claim 1, wherein the membranes are formed of a polymer.

7. The medical product of claim 6, wherein the polymer is polytetrafluoroethylene.

8. The medical product of claim 6, wherein the membranes are formed of Dacron.

9. The medical product of claim 1, comprising two membranes.

10. The medical product of claim 1, wherein the membranes are generally triangular in shape.

11. A method comprising:

providing a stentless valve in a body lumen, the stentless valve having a plurality of membranes, the plurality of membranes implanted in the body lumen and movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen.

12. The method of claim 11, wherein the stentless valve includes one or more barbs extending into a wall of the body lumen.

13. The method of claim 11, wherein the membranes are flexible.

14. The method of claim 11, wherein the membranes are configured to invert their shape in response to fluid flow in the body lumen.

15. A method of controlling flow in a body lumen, the method comprising:

moving a membrane of a stentless valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said membrane in said first position restricts fluid flow through the lumen in a first direction alone or in combination with one or more additional membranes, and wherein said membrane in said second position permits fluid flow through the lumen in the first direction alone or in combination with one or more additional membranes.

16. The method of claim 15, also comprising percutaneously implanting said stentless valve in the body lumen.

17. The method of claim 15, wherein said moving comprises inverting the shape of the membrane.

18. The method of claim 15, wherein the membrane in said second position and a portion of the body lumen form a cup for trapping the fluid.

19. The method of claim 15, comprising moving a plurality of membranes of a stentless valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said membranes in said first position restrict fluid flow through the lumen in a first direction, and wherein said membranes in said second position permit fluid flow through the lumen in the first direction.

20. The method of claim 17, wherein said inversion in shape is relative to the radial axis of the body lumen.

21. The method of claim 15, wherein said moving is in response to fluid flow in the body lumen.

22. A medical product, comprising:

a percutaneously implantable valve having a plurality of leaflets free from any separate support frame, the plurality of leaflets implantable in a body lumen and movable between a first position and a second position, wherein the leaflets are movable in response to fluid flow through the lumen.

23. The medical product of claim 22, wherein said leaflets are configured to flex in response to fluid flow in the body lumen.

24. The medical product of claim 22, wherein said leaflets are configured to invert their shape in response to fluid flow in the body lumen.

25. The medical product of claim 22, also including one or more barbs configured to embed in the body lumen.

26. The medical product of claim 22, wherein the leaflets are formed of a polymer.

27. The medical product of claim 26, wherein the polymer is polytetrafluoroethylene.

28. The medical product of claim 26, wherein the leaflets are formed of Dacron.

29. The medical product of claim 22, comprising two leaflets.

30. The medical product of claim 22, wherein the leaflets are generally triangular in shape.

31. A method comprising:

providing a valve implanted in a body lumen, the valve having a plurality of leaflets free from any separate support frame, the plurality of leaflets percutaneously implanted in the body lumen and movable between a first position and a second position, wherein the leaflets are movable in response to fluid flow through the lumen.

32. The method of claim 31, wherein the valve includes one or more barbs extending into a wall of the body lumen.

33. The method of claim 31, wherein the leaflets are flexible.

34. The method of claim 31, wherein the leaflets are configured to invert their shape in response to fluid flow in the body lumen.

35. A method of controlling flow in a body lumen, the method comprising:

moving a membrane of a valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein the valve is percutaneously implanted in the body lumen and is free from any separate support frame, wherein said membrane in said first position restricts fluid flow through the lumen in a first direction alone or in combination with one or more additional leaflets, and wherein said membrane in said second position permits fluid flow through the lumen in the first direction alone or in combination with one or more additional leaflets.

36. The method of claim 35, wherein said moving comprises inverting the shape of the membrane.

37. The method of claim 35, wherein the membrane in said second position and a portion of the body lumen form a cup for trapping the fluid.

38. The method of claim 35, comprising moving a plurality of leaflets of a stentless valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said leaflets in said first position restrict fluid flow through the lumen in a first direction, and wherein said leaflets in said second position permit fluid flow through the lumen in the first direction.

39. The method of claim 36, wherein said inversion in shape is relative to the radial axis of the body lumen.

40. The method of claim 35, wherein said moving is in response to fluid flow in the body lumen.

41. A method for treating a patient comprising:

providing a percutaneously implanted valve anchored in a body lumen of the patient, the percutaneously implanted valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen.

42. The method of claim 41, wherein the valve is anchored in the body lumen by barbs extending into the vessel wall.

43. The method of claim 41, wherein the valve lacks any separate support frame.

44. The method of claim 41, wherein the valve comprises a frame integral with said leaflets.

45. The method of claim 41, wherein said valve lacks any separate support frame and said leaflets include edge portions incorporating one or more materials or agents that increase the stiffness or resiliency of the edge portions.

46. The method of claim 41, wherein said valve comprises a plurality of leaflets.

47. A medical product, comprising:

a percutaneously implantable valve for introduction into a body lumen of a patient, the valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen; and

an expandable device upon which said valve is mounted, said expandable device configured to expand the valve into the wall of the body lumen.

48. The medical product of claim 47, wherein the expandable device is a balloon.

49. The medical product of claim 47, wherein the valve comprises one or more anchoring barbs.

50. The medical product of claim 47, wherein the valve comprises a plurality of anchoring barbs.

51. The medical product of claim 47, wherein the valve comprises a plurality of leaflets.

53. The medical product of claim 47, wherein the valve lacks any separate support frame.

54. The medical product of claim 47, wherein the valve comprises a frame integral with said leaflets.

55. The medical product of claim 47, wherein said valve lacks any separate support frame and said leaflets include edge portions incorporating one or more materials or agents that increase the stiffness or resiliency of the edge portions.