Implantable vascular device

• US 8,444,687 B2
• Filed: 02/26/2009
• Issued: 05/21/2013
• Est. Priority Date: 06/02/1998
• 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 Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Inventors: Pavcnik, Dusan, Keller, Frederick S., Rosch, Josef, Osborne, Thomas A., Bates, Brian L., Dixon, Christopher G., Hoffa, Andrew K., Leonard, Raymond B. II, Obermiller, Joseph F., DeFord, John A., Roberts, Joseph W.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US12/393,819
• Publication Number:
  US 20090157169A1
• Time in Patent Office: 1,545 Days
• Field of Search: None
• US Class Current: 623/1.24
• 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 method of treating a patient, comprising:

percutaneously delivering a medical product to a body lumen, the product including a stentless valve and further a catheter having an expandable member upon which the stentless valve is mounted, the stentless valve having a plurality of membranes free from any separate support frame and having a thickened peripheral edge, the entire stentless valve formed as a single piece, 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 plurality of membranes in said second position and a portion of the body lumen form a cup for trapping the fluid;

expanding the expandable member in the body lumen so as to force the valve against a wall of the body lumen; and

removing the catheter and the expandable member from the body lumen such that the valve remains anchored in the body lumen in the absence of a stent, wherein the anchored valve includes one or more barbs extending into the wall of the body lumen.

2. The method of claim 1, wherein said membranes flex in response to fluid flow in the body lumen.

3. The method of claim 1, wherein said membranes invert their shape in response to fluid flow in the body lumen.

4. The method of claim 3, wherein said membranes invert their shape relative to the radial axis of the body lumen.

5. The method of claim 1, wherein the membranes are formed of a polymer.

6. The method of claim 5, wherein the polymer is polytetrafluoroethylene.

7. The method of claim 5, wherein the membranes are formed of Dacron.

8. The method of claim 1, wherein the membranes are formed of a collagenous material.

9. The method of claim 1, comprising two membranes.

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

11. The method of claim 1, wherein the valve lacks radial expandability sufficient to anchor itself to the wall of the body lumen.

12. The method of claim 1, wherein the expandable member is a balloon.

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

percutaneously delivering a stentless valve to a body lumen, said stentless valve comprising a plurality of membranes free from any separate support frame and having a thickened peripheral edge, the entire stentless valve formed as a single piece;

forcing said plurality of membranes of said percutaneously-delivered stentless valve against a wall of said body lumen with a balloon such that one or more barbs attached to the plurality of membranes extend into the wall and anchors the plurality of membranes in the body lumen in the absence of a stent, wherein the anchored membranes are thereupon moveable 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, wherein the plurality of membranes in said second position and a portion of the body lumen form a cup for trapping the fluid.

14. The method of claim 13, wherein said membranes flex in response to fluid flow in the body lumen.

15. The method of claim 13, wherein said membranes invert their shape in response to fluid flow in the body lumen.

16. The method of claim 15, wherein said membranes invert their shape relative to the radial axis of the body lumen.

17. The method of claim 13, wherein the membranes are formed of a polymer.

18. The method of claim 13, wherein the polymer is polytetrafluoroethylene.

19. The method of claim 13, wherein the membranes are formed of Dacron.

20. The method of claim 13, wherein the membranes are formed of a collagenous material.

21. The method of claim 13, comprising two membranes.

22. The method of claim 13, wherein the membranes are generally triangular in shape.

23. The method of claim 13, wherein:

the valve lacks radial expandability sufficient to anchor itself to the wall of the body lumen.