Multiple-sided intraluminal medical device

• US 20030125795A1
• Filed: 11/14/2002
• Published: 07/03/2003
• Est. Priority Date: 06/02/1998
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Osborne, Thomas A., Keller, Frederick S., Rosch, Josef
• Granted Patent: US 6,974,474 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A multiple-sided medical device comprises a closed frame of a single piece of 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 that comprises a self-expanding stent. The stent is pushed from a delivery catheter into the lumen of a duct or vessel. One or more barbs are attached to the frame of the device for anchoring or to connect additional frames. A covering of fabric or other flexible material such as DACRON, PTFE, or collagen, is sutured or attached to the frame to form an occlusion device, a stent graft, or an artificial valve such as for correcting incompetent veins in the lower legs and feet. A partial, triangular-shaped covering over the lumen of the device allows the valve to open with normal blood flow and close to retrograde flow.

Claims

1-23. -23 (Canceled)

24. (Previously Added) A venous valve comprising:

a self-expanding frame that includes a plurality of sides that define an aperture through said frame, said frame adapted to resiliently conform to a vessel wall upon deployment thereagainst;

a covering comprising submucosa, said covering attached about at least selected ones of the plurality of sides such that said covering generally covers the entirety of said aperture except for a central opening within said covering; and

wherein said covering is adapted to selectively restrict fluid flow through said central opening in said covering when said frame is deployed against said vessel wall.

25. (Previously Added) The venous valve of claim 24, wherein the frame comprises a stent having four bends and four interconnecting sides.

26. (Previously Added) The venous valve of claim 24, wherein the bends comprise a coiled configuration.

27. (Previously Added) The venous valve of claim 24 wherein the covering consists of a single covering that includes a single opening extending therethrough.

28. (Previously Added) The venous valve of claim 24, wherein the covering comprises a curved structure adapted to cup or trap retrograde venous blood flow.

29. (Previously Added) An artificial venous valve configured for placement in the legs of patient to treat valvular incompetence comprising:

a self-expanding frame that includes a plurality of sides that define an aperture through said frame, said frame adapted to resiliently conform to a vessel wall upon deployment thereagainst;

a covering attached about the plurality of sides conforming to said vessel wall such that said covering generally covers the entirety of said aperture;

a opening extending through said covering adapted to selectively permit blood flow therethrough; and

wherein said covering is configured such that in response to retrograde venous blood flow, said covering forms a seal of the lumen of the vessel when said frame is deployed against said vessel wall.

30. (Previously Added) The artificial venous valve of claim 29, wherein said covering comprises submucosa.

31. (Previously Added) The venous valve of claim 29 wherein said covering consists of a single covering that includes an opening extending therethrough.

32. (Previously Added) An artificial venous valve configured for placement in the legs of patient to treat valvular incompetence comprising;

a self-expanding frame that includes a plurality of sides that define an aperture through said frame, said frame adapted to resiliently conform to a vessel wall upon deployment thereagainst;

a covering attached about the plurality of sides conforming to said vessel wall such that said covering generally covers the entirety of said aperture, said covering forming a continuous seal around said walls of the vessel; and

an opening extending through said covering adapted to selectively permit blood flow therethrough.

33. (Previously Added) The artificial venous valve of claim 32, wherein said covering comprises submucosa.

34. (Previously Added) The venous valve of claim 32 wherein said covering consists of a single covering including opening extending therethrough.

35. (New) An artificial venous valve configured for use in an incompetent vein of a leg or foot, comprising:

an artificial valve device adapted for deployment from a catheter lumen within an incompetent vein of a leg or foot;

said artificial valve device having a self-expanding frame of resilient material having a compressed configuration adapted for loading within a catheter lumen, and an expanded configuration wherein sides of the frame conform to the wall of the vein; and

said artificial valve device further having flexible covering material attached to said frame so as to act as an artificial valve with said frame in said expanded configuration;

said flexible covering material configured to trap retrograde blood flow between said flexible covering material and the wall of the vein in a closed condition of said artificial valve;

said flexible covering material configured to displace toward the wall of the vein in an open condition of said artificial valve.

36. (New) The artificial venous valve of claim 35, wherein said flexible covering material comprises collagen.

37. (New) The artificial venous valve of claim 36, wherein said flexible covering material comprises submucosa.

38. (New) A medical device for delivery of an artificial valve to an incompetent vein in a leg or foot, the medical device comprising:

(a) a catheter having a lumen; and

(b) an artificial valve device received in said lumen, the artificial valve device comprising;

a self-expanding frame of resilient material having a compressed configuration adapted for loading within a catheter lumen, and an expanded configuration wherein sides of the frame conform to the wall of the vein;

flexible covering material attached to said frame so as to act as an artificial valve with said frame in said expanded configuration;

said flexible covering material configured to trap retrograde blood flow between said flexible covering material and the wall of the vein in a closed condition of said artificial valve;

said flexible covering material configured to displace toward the wall of the vein in an open condition of said artificial valve.

39. (New) The artificial valve of claim 38, further comprising one or more barbs configured to engage said wall of the vein when said frame is in said expanded configuration.

40. (New) A method for treating an incompetent vein in a leg or foot, comprising:

deploying an artificial valve device from a lumen of a catheter in the incompetent vein, wherein the artificial valve device comprises;

a self-expanding frame of resilient material having a compressed configuration adapted for loading within the lumen of the catheter, and

an expanded configuration wherein Sides of the frame conform to the wall of the vein;

flexible covering material attached to said frame so as to act as an artificial valve with said frame in said expanded configuration;

said flexible covering material configured to trap retrograde blood flow between said flexible covering material and the wall of the vein in a closed condition of said artificial valve;

said flexible covering material configured to displace toward the wall of the vein in an open condition of said artificial valve.

41. (New) A method for providing an artificial vascular valve in a vascular vessel, comprising:

providing within said vascular vessel an artificial valve device, said artificial valve device having an expandable frame of resilient material and a covering comprising submucosa attached to said frame so as to act as an artificial valve.

42. (New) An artificial venous valve configured for use in an incompetent vein of a leg or foot, comprising:

a device adapted for deployment from a catheter lumen within an incompetent vein of a leg or foot;

said device having a self-expanding frame of resilient material having a compressed configuration adapted for loading within a catheter lumen, and an expanded configuration wherein sides of the frame conform to the wall of the vein; and

said device further having collagenous sheet material attached to said frame so as to act as an artificial valve with said frame in said expanded configuration;

said collagenous sheet material defining a cup extending longitudinally along said frame and configured to cup retrograde blood flow in a closed condition of said artificial valve;

said collagenous sheet material configured to displace toward the wall of the vein in an open condition of said artificial valve.

43. (New) The artificial venous valve of claim 42, wherein said collagenous sheet material comprises submucosa.

44. (New) A medical device for deployment of an artificial valve within an incompetent vein of a leg or foot, comprising:

(a) a catheter having a lumen; and

(b) an artificial venous valve received in the lumen of the catheter, the artificial venous valve comprising;

a self-expanding frame of resilient material having a compressed configuration adapted for loading within the catheter lumen of the catheter, and an expanded configuration wherein sides of the frame conform to the wall of the vein; and

said device further having collagenous sheet material attached to said frame so as to act as an artificial valve with said frame in said expanded configuration;

said collagenous sheet material defining a cup extending longitudinally along said frame and configured to cup retrograde blood flow in a closed condition of said artificial valve;

said collagenous sheet material configured to displace toward the wall of the vein in an open condition of said artificial valve.

45. (New) The artificial venous valve of claim 44, wherein said collagenous sheet material comprises submucosa.

46. (New) A method for treating an incompetent vein in a leg or foot, comprising:

deploying an artificial valve device from a lumen of a catheter in the incompetent vein, wherein the artificial valve device comprises;

a self-expanding frame of resilient material having a compressed configuration adapted for loading within the catheter lumen of the catheter, and an expanded configuration wherein sides of the frame conform to the wall of the vein; and

said device further having collagenous sheet material attached to said frame so as to act as an artificial valve with said frame in said expanded configuration;

said collagenous sheet material defining a cup extending longitudinally along said frame and configured to cup retrograde blood flow in a closed condition of said artificial valve;

said collagenous sheet material configured to displace toward the wall of the vein in an open condition of said artificial valve.

47. (New) An artificial vascular valve, comprising:

a frame of resilient material, the frame having a compressed configuration for delivery, and an expanded configuration for vascular deployment; and

a covering comprising submucosa attached to said frame so as to act as an artificial valve with said frame in said expanded configuration.

48. (New) A medical device for delivery of an artificial vascular valve, comprising:

(a) a catheter having a lumen; and

(b) an artificial vascular valve received within the lumen of the catheter, the artificial vascular valve comprising;

a frame of resilient material, the frame having a compressed configuration for receipt within the lumen of the catheter, and an expanded configuration for deployment within a vascular vessel; and

a covering comprising submucosa attached to said frame so as to act as an artificial valve with said frame in said expanded configuration.

49. (New) A method for providing an artificial vascular valve in a vascular vessel, comprising:

providing within said vascular vessel an artificial valve device, said artificial valve device having an expandable frame of resilient material and a covering comprising submucosa attached to said frame so as to act as an artificial valve.

50. (New) The method of claim 49, further including the step of engaging said artificial vascular valve with the wall of the vessel using one or more barbs attached to said artificial vascular valve.