Multiple-sided intraluminal medical device

• US 6,200,336 B1
• Filed: 06/02/1999
• Issued: 03/13/2001
• 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): Millin, Vincent
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/324,382
• Time in Patent Office: 650 Days
• Field of Search: 623/1, 623/11, 623/12, 623/1.13, 623/1.15, 623/1.16, 606/191-195, 606/198
• US Class Current: 623/1.15
• 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. A multiple-sided intraluminal medical device comprising:

a single frame (11) having a closed circumference (62) with an aperture (56) therethrough, said closed circumference having a plurality of sides (13), adjacent sides of said plurality of sides being interconnected by at least one bend (12), said frame adapted to assume a plurality of configurations, a first configuration (35) of said plurality of configurations being in a generally flat plane.

2. The device of claim 1 wherein at least one of said sides and said bends includes a flexible material and wherein a second configuration (36) of said plurality of configurations includes at least one pair of non-adjacent bends being closer together than in said first configuration.

3. The device of claim 2 wherein a third configuration (37) of said frame includes at least selected ones of said sides generally beside each other.

4. The device of claim 1 wherein said plurality of sides is four sides.

5. The device of claim 1 wherein said plurality of sides includes four sides of substantially equal length.

6. The device of claim 1 wherein said plurality of sides includes at least a first pair of adjacent sides, each side of said first pair having a length that is substantially equal to a first length, and a second pair of adjacent sides, each side of said second pair having a length that is substantially equal to a second length, said second length being substantially different from said first length.

7. The device of claim 1 further including at least one barb (16) extending from said frame.

9. The device of claim 1 wherein at least one of said bends comprises a coil (14).

10. The device of claim 1 wherein at least one of said bends comprises a fillet (41).

11. The device of claim 1 wherein at least one of said bends having a plurality of curves (63).

12. The device of claim 1 further comprising a covering (45) attached to at least two of said plurality of sides and partially covering said aperture.

20. The device of claim 1 further including at least one barb (16) extending from said frame.

21. The device of claim 20 further including a plurality of barbs (16).

22. The device of claim 21 wherein said frame comprises a single piece (59) of material having a first (60) and a second end (61), at least one of said barbs (16) comprising at least one of said first and said second ends.

28. The device of claim 20, further including a covering comprising a flexible material affixed to said frame.

29. The device of claim 28, wherein said covering covers said aperture.

30. The device of claim 28, wherein said covering comprises at least one partial covering 58, said at least one partial covering leaving a portion of said aperture is uncovered.

31. The device of claim 30, wherein said at least one partial covering 58 has a generally triangular shape.

32. The device of claim 28, wherein said covering comprises a material derived from collagen.

33. The device of claim 32, wherein said covering comprises a material derived from small intestinal submucosa.

8. A multiple-sided intraluminal medical device comprising:

a single frame (11) having a closed circumference (62) with an aperture (56) therethrough, said closed circumference having a plurality of sides (13), adjacent sides of said plurality of sides being interconnected by at least one bend (12), said frame adapted to assume a plurality of configurations, a first configuration (35) of said plurality of configurations being in a generally flat plane, wherein said frame includes at least a second frame (31) linearly connected to said first frame.

13. A multiple-sided medical device consisting of:

a single frame (11) having a closed circumference (62) with an aperture (56) therethrough, said closed circumference having a plurality of sides (13), wherein adjacent sides of said plurality of sides being interconnected by at least one bend (12), said frame having a plurality of configurations including a first configuration (35) of said frame being in a generally flat plane and second configuration (36) having at least one pair of non-adjacent bends being closer together than in said first configuration, and

a covering (45) attached to at least two of said plurality of sides.

14. The device of claim 13 wherein said covering generally covers said aperture (56).

15. The device of claim 14 wherein said covering further includes an opening (55) therethrough.

16. The device of claim 15 further comprising a tubular member disposed within said opening.

17. The device of claim 13 wherein said covering comprises a partial covering (58), said partial covering partially extending across said aperture when said frame is in said first configuration.

18. The device of claim 17 wherein said plurality of sides includes four sides and said partial covering is generally triangular in shape, said partial covering extending over nearly half of aperture or greater.

19. The device of claim 13 wherein said covering comprises a sleeve (64) attached to at least one said frame such that said frame in said second configuration has an open lumen (65) therethrough.

23. A multiple sided medical device comprising:

a frame (11) having a closed circumference (62) with an a aperture (56) therethrough, said closed circumference having a plurality of sides (13), wherein said plurality of sides includes four sides of substantially equal length, adjacent sides of said plurality of sides being interconnected by at least one bend (12) comprising a coil (14), said frame adapted to assume a plurality of configurations, a first configuration (35) of said plurality of configurations being in a generally flat plane, wherein a second configuration (36) of said frame includes at least one pair of non-adjacent bends being closer together than in said first configuration, wherein a third configuration (37) of said plurality of configurations includes at least selected ones of said sides generally beside each other;

a plurality of barbs (16) extending from said frame wherein said frame comprises a single piece (59) of material having a first (60) and a second end (61), at least one of said barbs (16) comprising at least one of said first and said second ends; and

a covering (45) wherein said covering comprises a partial covering (58), said partial covering partially extending across said aperture when said frame is in said first configuration, said partial covering is generally triangular and extending over at least nearly half of said aperture.

24. An intraluminal medical device consisting of:

a single frame 11 consisting of a closed circumference 59, said closed circumference having a plurality of sides 13 bounding only a single aperture 56 therethrough, adjacent ones of said plurality of sides being interconnects by at least one bend 12.

25. The device of claim 24 wherein said frame initially has a generally planar shape and assumes a nonplanar shape when diagonally opposed one of said bends are urged toward each other against spring bias to comprise associated pairs of said bends spaced from each other by distances essentially equal to the inner diameter of a catheter into which said frame is insertable for delivery to a vessel treatment site of a patient, with said associated pairs of bends being moved out of said generally planar shape in opposed directions from each other, and upon release from said catheter, said pair of associated bends of said frame move apart such that said frame self expands, tending to reassume said generally planar shape until said bends press against walls of said vessel at said treatment site.

26. The device of claim 25 wherein said frame has four sides, with opposing ones of sides being substantially equal in length.

27. The device of claim 26 wherein all of said sides are substantially of equal length.