Prosthesis for repair of body passages

• US 6,635,080 B1
• Filed: 01/03/2000
• Issued: 10/21/2003
• Est. Priority Date: 06/19/1997
• Status: Expired due to Term

• Current Assignee: Vascutek Limited (Terumo Corporation)
• Original Assignee: Vascutek Limited (Terumo Corporation)
• Inventors: Stevenson, David Granville, Healy, Karl James, Flynn, Kerry Elizabeth, OʼDonnell, Linda Ann, Lauterjung, Karl-Lutz
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/477,028
• Time in Patent Office: 1,387 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.17, 623/1.2, 623/2.38, 606/197, 606/198
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

A prosthesis that resiliently engages a body passage includes an annular clamping ring which may be folded along a diametric axis for insertion into the body passage. The clamping ring is adapted to resiliently spring outwardly, once in position inside the body passage, and to be continually resiliently biased against the interior surface of the body passage. One or more of the clamping rings may be attached to opposed ends of a tubular graft. The rings and connected graft may be positioned in the body passage using a applicator which selectively permits expansion and/or in some embodiments contraction of the annular ring in position within a body passage. Alternatively a retaining member may be used to retain the annular ring in a compressed condition until it is in a desired position within a body passage. Among other potential uses, the present invention may be useful as a vascular stent for treating abdominal aortic aneurysms.

Claims

1. A prosthetic graft for implantation in a body passage comprising:

a tubular graft body comprising at least a first end on said tubular graft body;

a first annular resilient element attached to said graft body adjacent said first end; and

a stent attached to said graft body, said stent comprised of a continuous wire having;

a plurality of circumferential rings, each ring having alternating peaks and valleys;

at least one strut connecting adjacent rings, said strut having a first end connected to a concave side of a peak of one ring and a second end connected to a concave side of a trough of an adjacent ring, wherein said continuous wire is doubled along a segment of a ring from a point in a trough where a first strut joins said ring to a point on a peak of said ring where a second strut leaves said ring; and

a first end adjacent said first annular element but being spaced away from said first annular element.

5. The graft of claim 1 wherein the rings are substantially equidistant from each other.

6. The graft of claim 1 wherein congruent peaks are colinear with respect to the length of said graft body.

7. The graft of claim 6 wherein congruent troughs are colinear with respect to the length of said graft body.

8. The graft of claim 1 wherein said peaks in each ring are uniform radially spaced around a circumference of said graft body.

9. The graft of claim 8 wherein said troughs in each ring are uniformly radially spaced around a circumference of said graft body.

10. The graft of claim 1 wherein said struts are uniformly radially spaced around said graft body.

11. The graft of claim 10 wherein adjacent struts are spaced approximately 180°

from each other.

12. The graft of claim 1 wherein congruent points on adjacent rings are spaced a uniform linear distance from each other.

13. The graft of claim 1 wherein said end of said stent is spaced a uniform distance away from said first annular element.

14. The graft of claim 13 wherein said distance is small enough to improve the stability of said prosthetic graft.

15. The graft of claim 14 wherein said distance is less than one diameter of said graft body.

16. The graft of claim 15 wherein said distance is less than one third of said diameter.

17. The graft of claim 16 wherein said distance is about 0.09 times the circumference of said graft body.

18. The graft of claim 1 wherein said first annular element is formed of a superelastic phase nickel-titanium alloy.

19. The graft of claim 1 wherein said stent is more flexible than said first annular element.

20. The graft of claim 19 wherein said first annular element is comprised of a plurality of strands of wire, and said stent is comprised of at least one strand of wire, the number of strands in said stent being less than the number of strands in said first annular element.

21. The graft of claim 20 wherein said number of wires in said stent is not more than one third of said number of wires in said first annular element.

22. The graft of claim 21 wherein said wires in said first annular element and said stent are formed of a superelastic phase nickel-titanium alloy.

23. The graft according to claim 1 wherein said graft body further comprises a second end and said graft further comprises a second annular resilient element attached to said graft body adjacent said second end, and said stent has a second end adjacent said second annular element but being spaced away from said second annular element.

24. The graft according to claim 1 wherein said continuous wire is adjacent itself along said doubled segment.

25. The graft according to claim 1 wherein said continuous wire is spaced apart from itself along said doubled segment, forming a gap between adjacent portions of said continuous wire.

26. The graft according to claim 25 wherein said gap is small compared to said distance between said rings.

27. The graft according to claim 26 wherein said gap is about one fifth of said distance between said rings.

28. The graft according to claim 1 wherein said trough where said first strut joins said ring is adjacent said peak where said second strut leaves said ring.

2. A prosthetic graft for implantation in a body passage comprising:

a tubular graft body comprising at least a first end on said tubular graft body;

a first annular resilient element attached to said graft body adjacent said first end;

a stent attached to said graft body, said stent comprised of a continuous wire that is a bundle of wires having;

a plurality of circumferential rings, each ring having alternating peaks and valleys;

at least one strut connecting adjacent rings, said strut having a first end connected to a concave side of a peak of one ring and a second end connected to a concave side of a trough of an adjacent ring, wherein said continuous wire is doubled along a segment of a ring from a point in a trough where a first strut joins said ring to a point on a peak of said ring where a second strut leaves said ring; and

a first end adjacent said first annular element but being spaced away from said first annular element.

29. The graft according to claim 2 wherein said continuous wire is adjacent itself along said doubled segment.

30. The graft according to claim 2 wherein said continuous wire is spaced apart from itself along said doubled segment, forming a gap between adjacent portions of said continuous wire.

31. The graft according to claim 30 wherein said gap is small compared to said distance between said rings.

32. The graft according to claim 31 wherein said gap is about one fifth of said distance between said rings.

33. The graft according to claim 2 wherein said trough where said first strut joins said ring is adjacent said peak where said second strut leaves said ring.

3. A prosthetic graft for implantation in a body passage comprising a tubular graft body and a stent attached to said graft body, said stent comprised of a continuous wire that is a bundle of wires having a plurality of circumferential rings, each ring having alternating peaks and valleys, and at least one strut connecting adjacent rings, said strut having a first end connected to a concave side of a peak of one ring and a second end connected to a concave side of a trough of an adjacent ring.

4. A prosthesis comprising:

a tubular body having first and second opposed ends and a first half including said first end and a second half including said second end;

a first annular wire bundle wound about a common axis proximate said first end and being located entirely in said first half;

a second annular wire bundle spaced from said first annular bundle, said second annular bundle being located entirely in said first half so that the region between said second annular wire bundle and said second end is free of wire, said first and second annular wire bundles each including a plurality of abutting, side-by-side wire loops.

34. The prosthesis of claim 4 wherein each of said bundles include a plurality of turns of wire.

35. The prosthesis of claim 34 wherein the number of turns of wire in said first annular wire bundle is greater than the number of turns of wire in said second annular wire bundle.

36. The prosthesis of claim 4 wherein said bundles are in the shape of an annular ring folded about a diametric axis.

37. The prosthesis of claim 36 wherein said bundles are held in said folded configuration by said tubular body.

38. The prosthesis of claim 37 wherein said tubular body is a fabric tube.

39. The prosthesis of claim 4 including a region of said tubular body between said first and second annular wire bundles that is free of any wire.

40. The prosthesis of claim 4 wherein said second annular wire bundle is more flexible than said first annular wire bundle.

41. The prosthesis of claim 4 wherein the distance between said first and second annular wire bundles is less than the diameter of said body.

42. The prosthesis of claim 4 wherein said first and second wire bundles are substantially identical.