Self expanding bifurcated endovascular prosthesis

• US 20020165602A1
• Filed: 04/08/2002
• Published: 11/07/2002
• Est. Priority Date: 06/19/1998
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Gilbert Madrid, Mehrdad M. Shokoohi, Myles S. Douglas
• Inventors: Shokoohi, Mehrdad M., Madrid, Gilbert, Douglas, Myles S.
• Granted Patent: US 7,520,895 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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

Abstract

Disclosed is a bifurcated tubular endoluminal vascular prosthesis, useful in treating, for example, an abdominal aortic aneurysm. The prosthesis comprises a self expandable wire support structure surrounded at least in part by a flexible tubular membrane. A delivery catheter and methods are also disclosed.

Claims

1. A bifurcated endoluminal prosthesis, comprising:

a proximal wire support section having a proximal end, a distal end and a central lumen extending therethrough;

a first wire branch section at the distal end of the proximal support; and

a second wire branch section at the distal end of the proximal support;

wherein at least the proximal support section and the first branch section are formed from a single length of wire.

2. An endoluminal prosthesis as in claim 1, wherein the proximal support comprises at least two axially adjacent tubular segments, joined by a connector therebetween.

3. An endoluminal prosthesis as in claim 2, wherein the proximal support comprises at least three segments and two connectors.

4. An endoluminal prosthesis as in claim 1, wherein the wire in each section comprises a series of proximal bends and a series of distal bends, creating a series of struts connecting the proximal bends and distal bends to form a tubular segment wall.

5. An endoluminal prosthesis as in claim 4, wherein at least some of the struts are substantially linear.

6. An endoluminal prosthesis as in claim 4, further comprising an eye on at least some of the bends.

7. An endoluminal prosthesis as in claim 6, wherein one or more eyes on a distal end of a first tubular segment are connected to one or more corresponding eyes on a proximal end of a second, axially adjacent tubular segment.

8. An endoluminal prosthesis as in claim 7, wherein the corresponding eyes are connected with a suture.

9. An endoluminal prosthesis as in claim 4, wherein each segment comprises from about 4 proximal bends to about 12 proximal bends.

10. An endoluminal prosthesis as in claim 1, further comprising a polymeric layer on the wire support.

12. A method of making a bifurcated endoluminal prosthesis, comprising the steps of:

providing a first length of wire;

forming the wire into two or more zig-zag sections, each zig-zag section separated by a crosslink;

rolling the formed wire about an axis to produce a proximal tubular support section and a first distal tubular branch;

providing a second length of wire formed into a tube; and

attaching the tube to the proximal tubular support section to produce a second distal tubular branch.

11. An endoluminal prosthesis as in claim 12, wherein the layer comprises a tubular PTFE sleeve surrounding at least a central portion of the prosthesis.

13. A method as in claim 12, further comprising the step of positioning a tubular polymeric sleeve concentrically on at least part of the prosthesis.

14. A method as in claim 13, wherein the positioning step comprises positioning the tubular polymeric sleeve concentrically on the outside surface of the prosthesis.

15. A method as in claim 14, wherein the tubular polymeric sleeve comprises PTFE.

17. An endoluminal prosthesis as in claim 16, wherein the proximal end of the support is self expandable to a greater diameter than the distal end of the support.

19. An endoluminal prosthesis as in claim 18, further comprising an outer tubular sleeve surrounding at least a portion of the prosthesis.

20. An endoluminal prosthesis as in claim 18, wherein at least one distal bend on a first segment is connected to at least one proximal bend from an adjacent segment.

21. An endoluminal prosthesis as in claim 20, wherein the connection comprises a pivotable connection.

22. An endoluminal prosthesis as in claim 21, wherein the connection comprises a metal link.

23. An endoluminal prosthesis as in claim 18, wherein at least a portion of the prosthesis has an expansion ratio of at least about 1:

4.

24. An endoluminal prosthesis as in claim 23, wherein at least a portion of the prosthesis has an expansion ratio of at least about 1:

5.

25. An endoluminal prosthesis as in claim 18, wherein at least a portion of the prosthesis has an expanded diameter of at least about 20 mm-30 mm in an unconstrained expansion, and the prosthesis is implantable using a catheter no greater than about 16 French.

26. A prosthesis as in claim 25, wherein at least a portion of the prosthesis has an expanded diameter of at least about 25 mm, and is implantable on a delivery device having a diameter of no more than about 16 French.

28. A method as in claim 27, wherein the proximally retracting a second branch sheath step is accomplished by pulling a wire connected to the second branch sheath.

29. A method as in claim 27, wherein the main vessel comprises the aorta and the first and second branch vessels comprise iliac arteries.

16. A multizone endoluminal bifurcation prosthesis, comprising:

a tubular wire support having a proximal end, a distal end, and a central lumen extending therethrough;

the wire support comprising at least a first and a second axially adjacent tubular segments, joined by a connector extending therebetween, wherein the first tubular segment has a different radial strength than the second tubular segment; and

a first and a second tubular wire branches connected to the distal end of the support to produce a multizone endoluminal bifurcation prosthesis.

18. An endoluminal prosthesis, comprising an elongate flexible wire, formed into a plurality of axially adjacent tubular segments spaced along an axis and defining a central lumen therethrough, each tubular segment comprising a zig zag section of the wire, having a plurality of proximal bends and distal bends, with the wire continuing between each adjacent tubular segment, wherein the prosthesis is radially compressible into a first, reduced cross sectional configuration for implantation into a body lumen, and self expandable to a second, enlarged cross sectional configuration at a treatment site in a body lumen, said prosthesis further comprising a first branch support section and a second branch support section each in communication with the lumen.

27. A method of implanting a self expandable tubular prosthesis at the junction of a main vessel and first and second branch vessels, comprising the steps of:

advancing a delivery catheter distally through a least a portion of the first branch and into the main vessel, the catheter containing a prosthesis having a main section and first and second branch sections;

distally advancing a main sheath on the catheter to deploy the main section of the prosthesis within the main vessel;

proximally retracting a first branch sheath on the catheter to deploy the first branch portion of the prosthesis within the first branch vessel; and

proximally retracting a second branch sheath on the catheter to deploy the second branch portion of the prosthesis within the second branch vessel.

30. A method of deploying first and second iliac branches of a self expandable prosthesis, comprising the steps of:

positioning the first and second iliac branches of the prosthesis within the first and second iliac arteries, respectively, while the first and second iliac branches of the prosthesis are constrained by first and second respective retention structures;

withdrawing the first retention structure from the first branch and transluminally through the first iliac to permit the first branch to expand; and

withdrawing the second retention structure from the second branch and transluminally through the second iliac to permit the second branch to expand.

31. A method as in claim 30, wherein the withdrawing the first retention structure step comprises withdrawing a tubular sheath from around the first branch.

32. A method as in claim 30, wherein the withdrawing the first retention structure step comprises pulling a pull wire transluminally positioned within the first iliac.

33. A deployment catheter for deploying a self expandable graft having a main vessel portion and first and second branch portions, comprising:

an elongate, flexible body;

a first sheath for containing the main vessel portion of the graft;

a second sheath for containing the first branch portion of the graft; and

a third sheath for containing the second branch portion of the graft.

34. A deployment catheter as in claim 33, wherein the first sheath is axially distally displaceable to deploy the main vessel portion of the graft.

35. A deployment catheter as in claim 33, further comprising a contralateral pull wire attached to the second sheath.

37. The combination of claim 36, further comprising a pull wire for pulling the second sheath proximally from the second branch portion.

38. The combination of claim 36, further comprising a main sheath axially movably positioned on the body for containing the main portion of the graft.

36. The combination of a deployment catheter and a bifurcation graft having a main portion and first and second branch portions, comprising:

an elongate flexible body, having proximal and distal ends;

the body extending through the main portion and first branch portion of the graft such that the main portion of the graft is disposed distally of the first portion of the graft;

a first sheath on the body for containing the first branch portion; and

a second sheath for containing the second branch portion.

39. A method of deploying a bifurcation graft at a bifurcation site in a vessel, comprising the steps of:

introducing a catheter having the bifurcation graft and at least one removable graft retention structure thereon through a first percutaneous puncture;

deploying the graft at the site;

removing the catheter through the first percutaneous puncture; and

removing the removable graft retention structure through a second percutaneous puncture.