Multiple-sided intraluminal medical device

• US 6,974,474 B2
• Filed: 11/14/2002
• Issued: 12/13/2005
• Est. Priority Date: 06/02/1998
• Status: Expired due to Term

• 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
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/294,987
• Publication Number:
  US 20030125795A1
• Time in Patent Office: 1,125 Days
• Field of Search: 623 124- 126, 623 21- 219, 623/2.42, 623/900, 623/1.47
• US Class Current: 623/1.24
• 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. 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, said frame having a plurality of side elements interconnected by a plurality of oppositely facing bends, said frame having a compressed configured adapted for loading within a catheter lumen wherein said bends are compressed and adjacent ones of said side elements are positioned generally beside one another in close proximity, and an expanded configuration wherein said side elements of the frame are adapted to 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, wherein said flexible covering material comprises submucosa;

said flexible covering material defining edge portions having an attachment extending along first and second ones of said side elements adapted to conform to the wall of the vein, said attachment and first and second ones of said side elements defining periphery portions of at least one curved structure between said artificial valve;

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

2. 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, said frame having a plurality of side elements interconnected by a plurality of oppositely facing bends, said frame having a compressed configuration adapted for loading within a catheter lumen wherein said bends are compressed and adjacent ones of said side elements are positioned generally beside one another in close proximity, and an expanded configuration wherein sides elements of the frame are adapted to conform to the wall of the vein in a path extending at least partially longitudinally along the wall of the vein when said frame is deployed thereagainst; and

said device further having collagenous sheet material including an attachment extending along said side elements of said frame so as to act as an artificial valve with said frame in said expanded configuration wherein said collagenous sheet material comprises submucosa;

said collagenous sheet material attached along said side elements adapted to conform to the wall of the vein in the path extending at least partially longitudinally along said frame and having peripheral portions extending along said path, said cup configured to cup retrograde blood flow between said collagenous sheet material and the wall of the vein 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.

3. 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, said frame having a plurality of side elements interconnected by a plurality of oppositely facing bends, said frame having a compressed configuration adapted for loading within the lumen of the catheter wherein said bends are compressed and adjacent ones of said elements are positioned generally beside one another in close proximity, and an expanded configuration wherein sides elements of the frame are adapted to conform to the wall of the vein when said frame is deployed thereagainst; and

said device further having collagenous sheet material including an attachment extending along said side elements of said frame so as to act as an artificial valve with said frame in said expanded configuration wherein said collagenous sheet material comprises submucosa;

said collagenous sheet material attached along said side elements adapted to conform to the wall of the vein in the path extending at least partially longitudinally along the wall of the vein and thereby defining a cup extending along said path, said cup configured to cup retrograde blood flow between said collagenous sheet material and the wall of the vein 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.

4. An artificial vascular valve, comprising:

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

a covering comprising submucosa attached to said frame so as to act as an artificial valve with said frame in said expanded configuration, said covering including at least one attached portion comprising submucosa attached extending along side elements of said expandable frame adapted to conform to a wall of the vascular site when said frame is said side elements to forcibly press the at least one portion comprising submucosa against the wall of the vascular site when said frame is expanded, said covering further including at least one movable portion comprising submucosa extendable transverse to the wall of the vascular site and adapted to be movable toward and away from the wall of the vascular site with said frame expanded at the vascular site.

5. The artificial vascular valve of claim 4, configured for deployment within a vein of a leg or foot.

6. 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, said covering including at least one attached portion comprising submucosa attached extending along side elements of said expandable frame adapted to conform to a wall of the vascular vessel to thereby cause said side elements to forcibly press the at least one attached portion comprising submucosa against the wall of the vascular vessel when said frame is expanded in the vascular vessel, said covering further including at least one movable portion comprising submucosa extendable transverse to the wall to the vascular vessel and adapted to be movable toward and away from the wall of the vascular vessel with said frame expanded in the vascular vessel.

7. The medical device of claim 6, wherein said artificial vascular valve is configured for deployment within a vein of a leg or foot.

8. A medical device for deployment at a vascular site, comprising:

a frame that is expandable for deployment of the medical device at a vascular site; and

flexible covering material comprising submucosa, said flexible covering material including at least one portion attached to the frame along side elements of the frame adapted to conform to a wall of the vascular site to thereby cause said side elements to forcibly press the flexible covering material against the wall of the vascular site with the frame in an expanded configuration, said flexible covering material further including at least one portion configured to provide flexible covering material extending transversely to the wall of the vascular site to partially, completely of selectively restrict blood flow to the vascular site.

9. The medical device of claim 8, wherein said flexable covering material defines an opening.

10. The medical device of claim 8, which is an occluder.

11. The medical device of claim 8, which is an artificial valve.

12. 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, said covering including at least one attached portion comprising submucosa attached extending along side elements of said expandable frame adapted to conform to a wall of the vascular vessel to thereby cause said side elements to forcibly press the at least one attached portion comprising submucosa against the wall of the vascular vessel when said frame is expanded in the vascular vessel, said covering further including at least one movable portion comprising submucosa extendable transverse to the wall of the vascular vessel and adapted to be movable toward and away from the wall of the vascular vessel with said frame expanded in the vascular vessel.