Delivery catheter and method for positioning an intraluminal graft

• US 6,045,557 A
• Filed: 08/17/1998
• Issued: 04/04/2000
• Est. Priority Date: 11/10/1995
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Baxter International Inc.
• Inventors: Yu, Weiyun, White, Geoffrey H.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/068,589
• Time in Patent Office: 596 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/195, 623/1
• US Class Current: 606/108
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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
• CPC Class Codes: A61F 2002/8483 Barbs

Abstract

A delivery catheter and method for positioning an intraluminal graft within a branching vessel in a patient'"'"'s body and a delivery catheter for use in that method is described. The delivery catheter comprises an elongate catheter having preferably an inflatable balloon adjacent one end, an intraluminal graft disposed about the balloon that bifurcates into two short tubular extensions, and a thin supplementary catheter containing a guidewire that extends upstream through one of the first tubular extensions and downstream through the other of the short tubular extensions of the graft. The method for positioning the intraluminal graft using the delivery catheter is particularly applicable to the appropriate positioning of a trouser graft so that it bridges an aneurysm which extends from a single vessel, such as the aorta, into one or more divergent vessels, for example, an iliac artery.

Claims

1. A delivery catheter comprising:

(a) an elongate catheter having a first end and a second end;

(b) an intraluminal graft having a body disposed about the elongate catheter, the body having at a first end, disposed adjacent to the first end of the elongate catheter, a tubular portion, and at a second end a bifurcation into first and second tubular graft extensions, the elongate catheter extending up the first tubular graft extension and into the tubular portion; and

(c) a supplementary guidewire extending in a first direction through the first tubular graft extension and projecting in a second different direction into the second tubular graft extension.

2. The delivery catheter of claim 1 wherein the supplementary guidewire extends through a channel in the graft body.

3. The delivery catheter of claim 1 wherein the elongate catheter has an inflatable balloon adjacent the first end and the intraluminal graft is disposed about the balloon.

4. The delivery catheter of claim 1 wherein a portion of the intraluminal graft proximate the first end is self-expandable.

5. The delivery catheter of claim 1 wherein one of the tubular graft extensions is of a greater length than the other tubular graft extension.

6. The delivery catheter of claim 1 wherein the guidewire is relatively thin and kink resistant.

7. The delivery catheter of claim 1 wherein the elongate catheter extends up the first tubular graft extension and through the tubular portion of the graft body.

8. The delivery catheter of claim 1 wherein the graft body is circumferentially supported along its length by a plurality of separate, spaced-apart wires each having a closed substantially sinusoidal continuously curved configuration having alternate apices.

9. The delivery catheter of claim 1 wherein the graft body is circumferentially supported along its length by a plurality of separate, spaced-apart wires, wherein each of the wires is interwoven with the graft body such that alternate portions of the wire are outside of the graft body with the remaining portions of the wire inside the graft body.

10. The delivery catheter of claim 1 wherein a supplementary catheter extends in the first direction through the first tubular graft extension and in the second direction into the second tubular graft extension, the supplementary catheter containing the supplementary guidewire.

11. The delivery catheter of claim 10 wherein the supplementary catheter is a 3 French catheter.

12. The delivery catheter of claim 10 wherein the supplementary catheter extends in the first direction through the first tubular graft extension and in the second direction into and through the second tubular graft extension.

13. The delivery catheter of claim 10 wherein the supplementary catheter is linked for part of its length to the elongated catheter.

14. The delivery catheter of claim 10 wherein the guidewire projects from a free end of the supplementary catheter.

15. The delivery catheter of claim 10 wherein at least a portion of the supplementary catheter is connected to at least a portion of the intraluminal graft.

16. The delivery catheter of claim 15 wherein the supplementary catheter is incorporated into a channel in the body of the graft.

17. The delivery catheter of claim 1 wherein both the first and second tubular graft extensions are adapted to engage with a further tubular intraluminal graft.

18. The delivery catheter of claim 17 wherein the further tubular intraluminal graft varies in outside diameter along its length.

19. The delivery catheter of claim 18 wherein the variation in outside diameter is provided by an inward taper of the graft along a portion of its length.

20. The delivery catheter of claim 18 wherein the variation in outside diameter is provided by an outward taper of the graft along a portion of its length.

21. The delivery catheter of claim 18 wherein a first portion of the further tubular intraluminal graft has a first outside diameter and a second portion has a different outside diameter.

22. The delivery catheter of claim 1 wherein the graft body is circumferentially reinforced proximate its first end by a plurality of separate, spaced-apart malleable wires, each of which has a generally closed sinusoidal shape, a first wire being located adjacent to the first end such that alternate crests or apices of the first wire projects beyond at least part of the first end.

23. The delivery catheter of claim 22 within the first wire has a greater amplitude than the next adjacent wire, and preferably the next two adjacent wires.

24. The delivery catheter of claim 22 wherein wires adjacent the first end of the graft are more closely spaced than wires distal the first end.

25. The delivery catheter of claim 22 wherein the graft body is fabricated from polyester, polytetrafluoroethylene, polyurethane or a composite thereof.

26. The delivery catheter of claim 22 the wires are interwoven with the graft body.

27. The delivery catheter of claim 26 the ends of each wire are twisted together on the outside of the graft body.

28. The delivery catheter of claim 1 wherein the tubular graft body is circumferentially supported along its length by a plurality of separate, spaced-apart wires, with a first wire being located adjacent the first end of the graft body such that portions of the first wire project beyond at least part of the first end.

29. The delivery catheter of claim 28 wherein each of the wires is interwoven with the graft body such that alternate portions of each wire are outside of the graft body with the remaining portions of each wire inside the graft body.

30. The delivery catheter of claim 28 wherein the graft body comprises a plurality of holes and wherein each of the wires are threaded through the holes such that alternate portions of the wire are outside of the graft body with the remaining portions of the wire inside the graft body.

31. The delivery catheter of claim 28 wherein the wires are sutured to the graft body.

32. The delivery catheter of claim 28 in which each end of the graft body is provided with a wire which has alternate crests or apices extending beyond the adjacent end of the graft body.

33. The delivery catheter of claim 32 wherein the wires adjacent the first end of the graft body are more closely spaced apart from each other than the wires intermediate the two ends of the graft body.

34. The delivery catheter of claim 33 wherein the first wire has a greater amplitude and a smaller wavelength than a majority of the other wires in the graft body.

35. The delivery catheter of claim 28 wherein each wire has a closed substantially sinusoidal continuously curved configuration having alternate apices, and wherein alternate apices of the first wire project beyond at least part of the first end.

36. The delivery catheter of claim 35 wherein the wavelength of the wires is substantially constant along the length of the graft body.

37. The delivery catheter of claim 35 wherein the first wire has a greater amplitude than the wire adjacent to it.

38. The delivery catheter of claim 35 wherein the first end of the graft body comprises an edge, and wherein the edge of the first end is scalloped between each projecting apex of the first wire.

39. The delivery catheter of claim 28 wherein each wire comprises two opposing ends, and wherein both ends of each wire are joined together on the outside of the graft body.

40. The delivery catheter of claim 39 wherein the joined ends of adjacent wires project in opposite directions along the graft body.

41. The delivery catheter of claim 39 wherein both ends of each wire are twisted or crimped together.

42. A method for positioning an intraluminal graft into a branching vessel within a patient'"'"'s body, the vessel comprising a single pre-branching vessel branching into a pair of post-branching vessels, the method comprising:

(a) introducing into one of the post-branching vessels a first intraluminal graft having a body having at a first end a tubular portion and a second end that is bifurcated into first and second tubular graft extensions, the body being disposed about a first elongate catheter, and there being positioned within the first intraluminal graft a supplementary guidewire which extends in a first direction through the first tubular graft extension and projects in a second different direction into the second tubular graft extension;

(b) positioning the first end of the first intraluminal graft and the second tubular graft extension within the pre-branching vessel and expanding that graft until at least the first end thereof expands into contact with a circumferential wall of the pre-branching vessel;

(c) extending the supplementary guidewire relative to the graft in the second different direction until it extends into the other of the post-branching vessels; and

(d) introducing a second intraluminal graft, having an upstream end and downstream end, into the other of the post-branching vessels and, utilising the supplementary guidewire, or another guidewire positioned in its place, moving the second intraluminal graft until its upstream end is within or surrounds the second tubular graft extension and its downstream end is within the other of the post-branching vessels and causing the upstream end of the second intraluminal graft to form fluid conveying engagement with the second tubular graft extension.

43. The method of claim 42 wherein the steps of introducing the second intraluminal graft into the other of the post-branching vessels and moving it until its upstream end is within the second tubular graft extension comprise:

(a) guiding a second elongate catheter, which has an uninflated balloon adjacent one end with the upstream end of the second intraluminal graft disposed about the balloon, over a smaller diameter guidewire and within a larger diameter catheter sheath pre-positioned in the other post-branching vessel and the pre-branching vessel;

(b) partially withdrawing the catheter sheath to free the second intraluminal graft;

(c) inflating the balloon and so expanding the upstream end of the second intraluminal graft until it engages against the second tubular graft extension;

(d) maintaining the inflation of the balloon while withdrawing the first elongate catheter from the one post-branching vessel; and

(e) once the first delivery catheter is removed from the one post-branching vessel deflating the balloon.

44. The method of claim 42 wherein the steps of introducing the first intraluminal graft into one of the post-branching vessels and positioning the first end and the second tubular graft extension within the pre-branching vessel comprise:

(a) guiding the first elongate catheter, which has a uninflated balloon adjacent one end with the first end of the first intraluminal graft disposed about the balloon, over a smaller diameter guidewire and within a larger diameter catheter sheath pre-positioned in the one post-branching vessel and pre-branching vessel;

(b) partially withdrawing the catheter sheath to free the first intraluminal graft;

(c) inflating the balloon and so expanding the first end of the first intraluminal graft until it engages against the pre-branching vessel wall; and

(d) deflating the balloon.

45. The method of claim 42 further comprising the step of:

(e) introducing a third intraluminal graft having an upstream end and a downstream end into the one post-branching vessel and moving the third intraluminal graft until its upstream end is within or surrounds the first tubular graft extension and its downstream end is within the one post-branching vessel and causing the upstream end of the third intraluminal graft to form fluid conveying engagement with the first tubular graft extension.

46. The method of claim 45 wherein the step of introducing the third intraluminal graft into the one post-branching vessel and moving it until its upstream end is within the first tubular graft extension comprises:

(a) guiding a third elongate catheter, which has an uninflated balloon adjacent one end with the upstream end of the third intraluminal graft disposed about the balloon, over a smaller diameter guidewire and within a larger diameter catheter sheath pre-positioned in the one post-branching vessel and the pre-branching vessel;

(b) partially withdrawing the catheter sheath to free the third intraluminal graft;

(c) inflating the balloon and so expanding the upstream end of the third intraluminal graft until it engages against the first tubular graft extension; and

(d) deflating the balloon.

47. A method for positioning an intraluminal graft across an aneurysm which extends from the aorta into at least one iliac artery within a patient'"'"'s body, the method comprising the steps of:

(a) making an incision or puncture to expose one of the patient'"'"'s femoral arteries;

(b) inserting a first guidewire through the exposed femoral artery, the corresponding iliac artery and the aorta such that it traverses the aneurysm;

(c) guiding a first catheter sheath over the first guidewire until it traverses the aneurysm;

(d) withdrawing the first guidewire;

(e) inserting a second relatively stiff guidewire through the first catheter sheath until it traverses the aneurysm;

(f) withdrawing the first catheter sheath;

(g) guiding a second relatively larger diameter catheter sheath over the second guidewire until it traverses the aneurysm;

(h) guiding a first elongate catheter, which has a uninflated balloon adjacent one end with a first intraluminal graft disposed about the balloon, over the second guidewire and within the second larger diameter catheter sheath, the first intraluminal graft having a body having at a first end a tubular portion and a second end that is bifurcated into first and second tubular graft extensions, there being positioned within the first graft a third catheter containing a third guidewire which extends in a first direction through the first tubular graft extension and in a second different direction into the second tubular graft extension;

(i) positioning the first elongate catheter so that the first end of the first graft is upstream of the aneurysm;

(j) partially withdrawing the second larger diameter catheter sheath to free the first intraluminal graft;

(k) inflating the balloon and so expanding the first end of the first intraluminal graft until it engages against the wall of the aorta above the aneurysm;

(l) deflating the balloon to allow blood to flow down the first graft distending the first and second tubular graft extensions;

(m) guiding the third guidewire in the second direction downstream into the other of the iliac and femoral arteries;

(n) making an incision or puncture and retrieving the third guidewire from the other femoral artery;

(o) withdrawing the third catheter through the one femoral artery;

(p) guiding a fourth catheter sheath over the third guidewire and through the other femoral and iliac arteries until it is within the first graft and reaches at least to the top of the second tubular graft extension;

(q) withdrawing the third guidewire through the one femoral artery;

(r) guiding a fourth relatively large diameter guidewire through the fourth catheter sheath until the guidewire reaches at least the top of the second tubular graft extension;

(s) withdrawing the fourth catheter sheath through the other femoral artery;

(t) guiding a fifth relatively larger diameter catheter sheath over the fourth guidewire until the fifth catheter sheath reaches at least the top of the second tubular graft extension;

(u) guiding a second elongate catheter, which has a uninflated balloon adjacent one end with a second intraluminal graft, having an upstream end and a downstream end, disposed about the balloon, over the fourth guidewire and within the fifth larger diameter catheter sheath until the upstream end of the second graft is within the second tubular graft extension;

(v) partially withdrawing the fifth catheter sheath to free the second intraluminal graft;

(w) inflating the balloon on the second delivery catheter and so expanding the upstream end of the second intraluminal graft until it engages against the second tubular graft extension;

(x) maintaining the inflation of the balloon while withdrawing the first elongate catheter from the one femoral artery;

(y) once the first elongate catheter is removed from the one femoral artery deflating the balloon;

(z) fully withdrawing the fifth catheter sheath through the other femoral artery;

(aa) guiding a third elongate catheter, which has an uninflated balloon adjacent one end with a third intraluminal graft, having an upstream end and a downstream end, disposed about the balloon, over the second guidewire and within the second catheter sheath until the upstream end of the third graft is within the first tubular graft extension;

(bb) partially withdrawing the second catheter sheath to free the third intraluminal graft;

(cc) inflating the balloon on the third elongate catheter and so expanding the upstream end of the third intraluminal graft until it engages against the first tubular graft extension;

(dd) deflating the balloon on the third elongate catheter;

(ee) withdrawing the second elongate catheter through the other femoral artery and the third elongate catheter through the one femoral artery;

(ff) withdrawing the fourth guidewire and the fifth catheter sheath through the other femoral artery and suturing the incision or puncture in that artery;

(gg) withdrawing the second guidewire and second catheter sheath through the one femoral artery and suturing the incision or puncture in that artery.

48. The method of claim 47 wherein in an alternative step (l) the first and second tubular graft extensions are distended respectively by an inflatable balloon or are self-expandable.