Endoluminal vascular prosthesis

• US 6,077,296 A
• Filed: 03/04/1998
• Issued: 06/20/2000
• Est. Priority Date: 03/04/1998
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Shokoohi, Mehrdad M., Henson, Michael R., Hoffmann, Gerard von
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/034,689
• Time in Patent Office: 839 Days
• Field of Search: 623/1, 623/11, 623/12
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/90 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

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

Claims

1. An endoluminal 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 segment, each tubular segment comprising a series of proximal and distal bends, wherein the tubular segments are joined by a connector extending therebetween;

wherein the first and second segments and the connector are formed from a single length of wire; and

wherein at least a first distal bend in the first tubular segment is connected to at least a first proximal bend in the second tubular segment, and at least one of the first proximal bend and the first distal bend includes an eye thereon.

2. An endoluminal prosthesis as in claim 1, comprising at least three segments and two connectors.

3. An endoluminal prosthesis as in claim 1, comprising at least five segments and four connectors.

4. An endoluminal prosthesis as in claim 1, comprising a series of struts connecting the proximal bends and distal bends within a segment to form a tubular segment wall, wherein at least some of the struts are substantially linear.

5. An endoluminal prosthesis as in claim 1, wherein one or more eyes on a distal end of the first tubular segment are connected to one or more corresponding eyes on a proximal end of the second tubular segment.

6. An endoluminal prosthesis as in claim 1, wherein each segment comprises from about 4 proximal bends to about 12 proximal bends.

7. An endoluminal prosthesis as in claim 1, having at least a proximal segment, an intermediate segment and a distal segment, wherein the prosthesis is expandable from a reduced cross section to an expanded cross section.

8. An endoluminal prosthesis as in claim 7, wherein at least a portion of the proximal segment and distal segment is larger in cross section than the central segment when the prosthesis is in the expanded cross section.

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

10. An endoluminal prosthesis as in claim 9, wherein the layer comprises a tubular PTFE sleeve surrounding at least a central portion of the prosthesis.

11. An endoluminal prosthesis as in claim 5, wherein corresponding eyes are connected with a suture.

12. An endoluminal prosthesis as in claim 5, wherein corresponding eyes are connected with a ring.

13. An endoluminal prosthesis as in claim 9, wherein the polymeric layer comprises PTFE.

14. An endoluminal prosthesis as in claim 9, wherein the support is embedded in the polymeric layer.

15. An endoluminal prosthesis as in claim 14, wherein the polymeric layer comprises PTFE.

16. A method of making an endoluminal prosthesis, comprising the steps of:

providing a length of wire;

forming the wire into two or more zig-zag sections, each zig-zag section comprising a series of proximal and distal bends, wherein the zig-zag sections are separated by a crosslink;

forming at least one eye on at least one of the proximal and distal bends;

rolling the formed wire about an axis to produce a series of tubular elements positioned along the axis such that each tubular element is connected to an adjacent tubular element by a link; and

connecting at least some of the proximal bends in one tubular element to at least some of the distal bends in the adjacent tubular element.

17. A method as in claim 16, further comprising the step of positioning a tubular polymeric sleeve concentrically on at least one of the tubular elements.

18. A method as in claim 17, wherein the positioning step comprises positioning the tubular polymeric sleeve concentrically on the outside surface of the tubular element.

19. A method as in claim 18, wherein the tubular polymeric sleeve comprises PTFE.

20. A multizone endoluminal 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, each tubular segment comprising a series of proximal and distal bends, wherein the tubular segments are joined by a connector extending therebetween;

wherein the first tubular segment has a different radial strength than the second tubular segment; and

wherein at least some of the proximal bends in the first tubular segment are connected to at least some of distal bends in the second tubular segment.

21. An endoluminal prosthesis as in claim 20, further comprising a third tubular segment, wherein at least one of the tubular segments has a different radial strength than the other two tubular segments.

22. An endoluminal prosthesis as in claim 21, wherein a proximal end of the prosthesis is self expandable to a greater diameter than a central region of the prosthesis.

23. A multizone endoluminal prosthesis as in claim 20, further comprising an eye on at least one of the proximal bends.

24. A multizone endoluminal prosthesis as in claim 20, further comprising an eye on at least one of the distal bends.

25. An endoluminal prosthesis, comprising an elongate flexible wire, formed into a plurality of axially adjacent tubular segments spaced along an axis, each tubular segment comprising a zig zag section of the wire, having a plurality of proximal bends and distal bends, at least one of the plurality of proximal bends and plurality of distal bends having loops thereon, 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, and wherein at least some of the proximal bends in one tubular segment are connected to at least some of distal bends in the adjacent tubular segment.

26. An endoluminal prosthesis as in claim 25, comprising at least three segments formed from said wire.

27. An endoluminal prosthesis as in claim 26, further comprising an outer tubular sleeve surrounding at least a portion of the prosthesis.

28. An endoluminal prosthesis as in claim 27, wherein the sleeve further comprises at least one lateral perfusion port extending therethrough.

29. An endoluminal prosthesis as in claim 26, wherein the prosthesis has a proximal end and a distal end, and at least one of the proximal end and distal end as expandable to a larger diameter than a central section of the prosthesis in an unconstrained expansion.

30. An endoluminal prosthesis as in claim 25, wherein at least one distal bend on a first segment is connected to at least one proximal bend from an adjacent segment.

31. An endoluminal prosthesis as in claim 30, wherein the connection comprises a pivotable connection.

32. An endoluminal prosthesis as in claim 31, wherein the connection comprises a metal link.

33. An endoluminal prosthesis as in claim 31, wherein the connection comprises a suture.

34. An endoluminal prosthesis as in claim 25, wherein the prosthesis has an expansion ratio of at least about 1:

4.

35. An endoluminal prosthesis as in claim 34, wherein the prosthesis has an expansion ratio of at least about 1:

5.

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

37. A prosthesis as in claim 36, wherein 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.

38. A method of implanting an endoluminal vascular prosthesis, comprising the steps of:

providing a self expandable endoluminal vascular prosthesis, having a proximal end, a distal end and a central lumen extending therethrough, said prosthesis comprising a plurality of axially adjacent tubular segments, 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 at least some of the proximal bends in one tubular segment are connected to at least some of distal bends in the adjacent tubular segment, and wherein said prosthesis is expandable from a first, reduced diameter to a second, enlarged diameter;

mounting the prosthesis on a catheter, such that when the prosthesis is in the reduced diameter configuration on the catheter, the catheter diameter through the prosthesis is no more than about 16 French;

introducing the catheter into a body lumen, and positioning the prosthesis at a treatment site in the body lumen;

releasing the prosthesis at the treatment site, such that the prosthesis expands from the first diameter to the second diameter;

wherein the second diameter is at least about 20 mm.