Implantable vascular device

• US 7,520,894 B2
• Filed: 06/22/2005
• Issued: 04/21/2009
• Est. Priority Date: 02/03/2000
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), Cook Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Inventors: Roberts, Joseph W., DeFord, John A., Pavcnik, Dusan, Bates, Brian L., Dixon, Christopher G., Hoffa, Andrew K., Osborne, Thomas A., Keller, Frederick S., Rosch, Josef, Obermiller, Joseph F., Leonard, Raymond B. II
• Primary Examiner(s): Willse; David H
• Assistant Examiner(s): Blanco; Javier G
• Application Number:
  US11/165,600
• Publication Number:
  US 20060142846A1
• Time in Patent Office: 1,399 Days
• Field of Search: 623/1.24, 623/1.26, 623 212- 219, 623/900
• US Class Current: 623/1.26
• 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 deliverable by catheter through a body lumen, the plurality of membranes implantable in the body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

2. The medical product of claim 1, also comprising an expandable delivery device upon which said membranes are mounted, said expandable delivery device configured to expand to force the membranes into the wall of the body lumen for delivery of the stentless valve.

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 2, also including one or more barbs attached to the stentless valve and configured to embed in the body lumen upon expansion of the expandable delivery device, and further wherein the expandable delivery device is a balloon.

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 delivered by catheter through the body lumen, the plurality of membranes implanted in the body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

12. The method of claim 11, wherein one or more barbs are attached to the stentless valve and extend 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 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, the plurality of membranes delivered by catheter through the body lumen and implanted in the lumen in the absence of a stent, wherein said plurality of membranes in said first position restricts fluid flow through the lumen in a first direction, and wherein said plurality of membranes in said second position permits fluid flow through the lumen in the first direction, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

16. The method of claim 15, also comprising expanding an expandable delivery member upon which said plurality of membranes are mounted so as to force said plurality of membranes against a wall of the body lumen for delivery of the stentless valve.

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

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

19. The method of claim 15, wherein the stentless valve includes one or more attached barbs configured to embed in the body lumen upon expansion of the expandable delivery member.

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 stentless valve having a plurality of leaflets free from any separate support frame and deliverable by catheter through a body lumen, 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, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

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 attached to the stentless valve and 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 stentless valve to be implanted in a body lumen, the valve having a plurality of leaflets free from any separate support frame and deliverable by catheter through the body lumen, the plurality of leaflets compressible and percutaneously implantable 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, and wherein the stentless valve is formed as a single piece.

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 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 the valve is delivered by catheter through the body lumen and implanted in the body lumen free from any separate support frame, wherein said plurality of membranes in said first position restricts fluid flow through the lumen in a first direction, and wherein said plurality of membranes in said second position permits fluid flow through the lumen in the first direction, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

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

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

38. The method of claim 35, wherein one or more barbs are attached to the stentless valve and extend into a wall of the body lumen.

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 stentless valve anchored in a body lumen of the patient in the absence of a separate support frame, the valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen, wherein the valve is delivered by catheter to the body lumen, wherein the stentless valve is compressible and percutaneously deliverable, and wherein the stentless valve is formed as a single piece.

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

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

44. The method of claim 41, wherein said leaflets include edge portions incorporating one or more materials or agents that increase the stiffness or resiliency of the edge portions.

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