Intraluminal grafting of a bifuricated artery

• US 6,099,558 A
• Filed: 01/25/1999
• Issued: 08/08/2000
• Est. Priority Date: 11/10/1995
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yu, Weiyun, White, Geoffrey H.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/068,587
• Time in Patent Office: 561 Days
• Field of Search: 623/1, 623/12, 623/1.16, 623/1.13, 623/1.35, 606/198, 606/195, 128/898
• US Class Current: 623/1.16
• 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 method for positioning an intraluminal graft within a branching vessel in a patient'"'"'s body is described. The method is particularly applicable to the appropriate positioning of a trouser graft so that it bridges an aneurism which extends from a single vessel, such as the aorta, into one or more divergent vessels, for example, an iliac artery. The method can comprise the steps a of placing a first graft (10), that bifurcates in a pair of tubular sections (19a, 19b) into the pre-branching portion of a vessel (11) through one of the post-branching portions of the vessel (12, 13), positioning a second tubular graft (10b) into one of the post-branching portions (12) and connecting it to one of the tubular sections of the first graft (19a), and positioning a third tubular graft (10a) into the other of the post-branching portions (11) and connecting it to the other of the tubular sections of the first graft (19b).

Claims

1. A method for positioning a bifurcated graft across a distended region of a main vessel adjacent a bifurcation of the main vessel into an ipsilateral vessel and a contralateral vessel, the method comprising:

introducing a catheter pre-packaged with a bifurcated graft therein into the ipsilateral vessel and then into the main vessel to a point beyond the distended region, the bifurcated graft having a tubular main portion branching into two tubular extensions at a bifurcation point, namely, an ipsilateral extension and a contralateral extension;

deploying the bifurcated graft from within the catheter so that the tubular main portion contacts the walls of the main vessel at a point beyond the distended region and the tubular extensions are located within the distended region and pointing toward respective ipsilateral and contralateral vessels;

delivering a flexible guidewire through the ipsilateral vessel and ipsilateral extension and causing it to deflect around the bifurcation point into the contralateral extension and then into contralateral vessel;

deploying a tubular contralateral graft through the contralateral vessel using the flexible guidewire;

engaging a first end of the contralateral graft with the contralateral extension;

engaging a second end of the contralateral graft with the contralateral vessel;

deploying a tubular ipsilateral graft through the ipsilateral vessel;

engaging a first end of the ipsilateral graft with the ipsilateral extension; and

engaging a second end of the ipsilateral graft with the ipsilateral vessel.

2. The method of claim 1, wherein the step of deploying the contralateral graft includes:

a. using the flexible guidewire as a locator within the contralateral extension of the bifurcated graft to deliver a stiff guidewire into the contralateral extension from the contralateral vessel; and

b. passing the contralateral graft over the stiff guidewire into the contralateral extension.

3. The method of claim 2, further including:

a. passing an exchange catheter from the contralateral vessel over the flexible guidewire until the exchange catheter is within the contralateral extension;

b. removing the flexible guidewire from within the exchange catheter;

c. passing the stiff guidewire from the contralateral vessel through the exchange catheter until the stiff guidewire is within the contralateral extension; and

d. removing the exchange catheter.

4. The method of claim 2, wherein the step of passing the contralateral graft over the stiff guidewire into the contralateral extension comprises:

a. passing a sheath over the stiff guidewire; and

b. passing a catheter having the contralateral graft packaged thereon through the sheath and into the contralateral extension.

5. The method of claim 4, wherein the step of engaging a first end of the contralateral graft with the contralateral extension includes:

a. balloon expanding the first end of the contralateral graft into engagement with the contralateral extension using a balloon on the catheter on which the contralateral graft is packaged.

6. The method of claim 1, wherein the step of deploying the ipsilateral graft through the ipsilateral vessel and engaging the first end of the ipsilateral graft with the ipsilateral extension includes:

a. passing a stiff guidewire from the ipsilateral vessel and into the ipsilateral extension;

b. passing a sheath over the stiff guidewire;

c. passing a catheter having the contralateral graft packaged thereon through the sheath and into the ipsilateral extension; and

d. balloon expanding the first end of the ipsilateral graft into engagement with the ipsilateral extension using a balloon on the catheter on which the ipsilateral graft is packaged.

7. The method of claim 1, wherein the ipsilateral and contralateral vessels are located downstream in the blood flow from the main vessel, and wherein the step of delivering a flexible guidewire includes the step of deploying means on the end of the flexible guidewire for helping the bloodstream to carry the end of the guidewire through the contralateral vessel.

8. The method of claim 7, wherein step of deploying means on the end of the flexible guidewire includes inflating a balloon located on the end of the guidewire.

9. The method of claim 7, wherein step of deploying means on the end of the flexible guidewire includes expanding an umbrella-like structure located on the end of the guidewire.

22. The bifurcated graft assembly of claim 1, wherein each of the wires woven through the graft body has a generally closed sinusoidal shape with an amplitude.

10. A bifurcated graft assembly for bridging a distended region of a main vessel adjacent a bifurcation of the main vessel into two branching vessels, the assembly comprising:

a. a bifurcated graft having a tubular main portion branching into two tubular extensions at a bifurcation point, the bifurcated graft including a graft body reinforced with a plurality of separate and spaced apart wires in the main portion and tubular extensions, wherein at least the wires in the main portion are woven through the graft body, and at least a wire at the ends of the tubular extensions is self-expanding; and

b. at least one tubular graft sized to connect between one of the tubular extensions of the bifurcated graft and the respective branching vessel, the tubular graft having a graft body reinforced with wires, wherein a wire in a first end of the tubular graft is balloon-expandable, the first end of the tubular graft being overlapped within and being capable of outward expansion into frictional engagement with the end of the tubular extension to form the graft assembly.

11. The bifurcated graft assembly of claim 10, wherein there are a pair of the tubular grafts sized to connect between both tubular extensions of the bifurcated graft and the respective branching vessels, the tubular grafts each having a graft body reinforced with wires, wherein a wire in a first end of each of the tubular grafts is balloon-expandable, the first end of each of the tubular grafts being overlapped within and being capable of outward expansion into frictional engagement with the ends of the tubular extensions to form the graft assembly.

12. The bifurcated graft assembly of claim 10, wherein each of the wires woven through the graft body has a generally closed sinusoidal shape with adjacent crests extending in opposite directions, wherein the wires are generally disposed inside the graft body with alternate crests woven through to the outside of the graft body.

13. The bifurcated graft assembly of claim 10, wherein each of the wires woven through the graft body has a generally closed sinusoidal shape with an amplitude.

14. The bifurcated graft assembly of claim 10, wherein at least one of the wires in the main portion has a different amplitude than the other wires.

15. The bifurcated graft assembly of claim 14, wherein the wire located closest to the end of the main portion has a larger amplitude than the other wires in the main portion.

16. The bifurcated graft assembly of claim 10, wherein the wires in the main portion of the bifurcated graft are balloon-expandable.

17. A bifurcated graft assembly for bridging a distended region of a main vessel adjacent a bifurcation of the main vessel into two branching vessels, the assembly comprising:

a. a bifurcated graft having a tubular main portion branching into two tubular extensions at a bifurcation point, the bifurcated graft including a bifurcated graft body reinforced with a plurality of separate and spaced apart wires in the main portion and tubular extensions each of which has a generally closed sinusoidal shape, at least one wire at the ends of each of the tubular extensions is self-expanding, a first wire being located adjacent to the end of the main portion of the bifurcated graft body such that alternate apices of the first wire projects beyond at least part of the end; and

b. at least one tubular graft sized to connect between one of the tubular extensions of the bifurcated graft and the respective branching vessel, the tubular graft having a graft body reinforced with wires, wherein a wire in a first end of the tubular graft is balloon-expandable, the first end of the tubular graft being overlapped within and being capable of outward expansion into frictional engagement with the end of the tubular extension to form the graft assembly.

18. The bifurcated graft assembly of claim 17, wherein there are a pair of the tubular grafts sized to connect between both tubular extensions of the bifurcated graft and the respective branching vessels, the tubular grafts each having a graft body reinforced with wires, wherein a wire in a first end of each of the tubular grafts is balloon-expandable, the first end of each of the tubular grafts being overlapped within and being capable of outward expansion into frictional engagement with the ends of the tubular extensions to form the graft assembly.

19. The bifurcated graft assembly of claim 17, wherein the wires in the main portion of the bifurcated graft are balloon-expandable.

20. The bifurcated graft assembly of claim 17, wherein the end of the main portion of the bifurcated graft body includes an edge which is scalloped between each projecting apex of the first wire.

21. The bifurcated graft assembly of claim 17, wherein at least the wires in the main portion are woven through the graft body, wherein the wires are generally disposed inside the graft body with alternate apices woven through to the outside of the graft body.

23. The bifurcated graft assembly of claim 17, wherein at least one of the wires in the main portion has a different amplitude than the other wires.

24. The bifurcated graft assembly of claim 23, wherein the first wire has a larger amplitude than the other wires in the main portion.