Non-migrating vascular prosthesis and minimally invasive placement system therefor

• US 6,004,347 A
• Filed: 12/04/1996
• Issued: 12/21/1999
• Est. Priority Date: 04/22/1993
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: McNamara, Edward I., Weiser, Michael F.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/760,360
• Time in Patent Office: 1,112 Days
• Field of Search: 604/104, 604/105, 604/106, 606/191, 606/192, 606/194, 606/198, 606/199, 606/200, 623/1, 623/11
• US Class Current: 623/23.64
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A graft assembly for securely position a graft at a predetermined location across an abdominal aortic aneurysm. The assembly includes a resilient self expanding anchor that is secured to the distal end of a mesh graft. The anchor is formed from a single wire having a series of zigzag bends, such that when the ends of the wire are attached a tubular anchor is produced. The anchor is further characterized by curved segments between the bends which a create an anchor having a reverse barrel shape.

Claims

1. A vascular repair assembly adapted to inhibit migration of the assembly once it is positioned within a blood vessel, comprising:

an elongate tubular graft having a proximal end and a distal end;

a fixed length self-expanding anchor having a proximal end, a distal end and an intermediate portion defined by a plurality of generally longitudinally extending curved anchor segments, the anchor being secured to the distal end of the graft, each of the anchor segments extending substantially the full length of the anchor;

the curve of the anchor segments being oriented radially outwardly toward each of the proximal and distal ends of the anchor so that both the distal and proximal ends of the anchor define diameters greater than that of the intermediate portion.

2. A repair assembly according to claim 1, wherein said anchor has a tubular shape with a longitudinal axis and has a diameter which varies along said longitudinal axis.

3. A repair assembly according to claim 2, wherein said anchor comprises a single, continuous wire which includes a series of bends, the anchor segments being defined by those portions of the wire that extend between the bends.

4. A repair assembly according to claim 2, wherein at least one hook is secured adjacent said distal end of said anchor.

5. A repair assembly according to claim 2, wherein said distal end and said proximal end of said anchor have the same diameter which is larger than a diameter of said intermediate portion of said anchor.

6. A repair assembly according to claim 1, wherein said anchor comprises a single, continuous wire.

7. A repair assembly according to claim 6, wherein said single wire includes a series of bends and radially outwardly curved anchor segments connecting sequential bends in said series of bends, and said wire has first and second ends that are joined together to form a three-dimensional structure having a generally tubular shape.

8. A repair assembly according to claim 7, wherein said anchor has a longitudinal axis, and said radially outwardly curved anchor segments are oriented such that the diameter of said anchor varies along said longitudinal axis.

9. A repair assembly according to claim 8, wherein said distal end and said proximal end of said anchor have the same diameter which is larger than a diameter of said intermediate portion of said anchor.

10. A repair assembly according to claim 6, wherein said wire is metal.

11. A repair assembly according to claim 1, wherein said distal end of said graft is secured to said anchor adjacent said proximal end of said anchor.

12. A repair assembly according to claim 1, wherein at least one hook is secured adjacent said distal end of said anchor.

21. The repair assembly recited in claim 1 wherein said anchor is resilient and said radially outwardly curved intermediate portion concentrates said resiliency at said proximal and distal ends of said anchor.

13. A method for repairing injured blood vessels comprising the steps of:

attaching a self expanding anchor to a distal end of a graft;

positioning said anchor and said graft at a predetermined location within a blood vessel; and

securing said anchor within said blood vessel such that migration of said graft is prevented;

wherein said anchor comprises;

a generally tubular fixed length structure formed from a plurality of fixed length radially outwardly curved anchor segments which extend from the proximal end of said anchor to the distal end of said anchor, the proximal and distal ends of the anchor defining a plurality of circumferentially spaced anchor regions disposed about circles, each of which has a greater diameter than the diameter defined by the midportion of the anchor as the result of the curvature of the anchor segments, the number of the circumferentially spaced anchor regions being selected to focus the radially outward pressure applied by the self expanding anchor against the blood vessel wall to a small number of points along the circle.

14. A method according to claim 13, wherein said anchor comprises a single, continuous wire.

15. A method according to claim 14, wherein said single wire includes a series of bends and radially outwardly curved anchor segments extending between adjacent of said bends, and said wire has first and second ends that are joined together to form a three-dimensional structure having a generally tubular shape.

16. A method according to claim 15, wherein said anchor has a longitudinal axis, and said radially outwardly curved anchor segments are oriented such that the diameter of said anchor varies along said longitudinal axis.

17. A method according to claim 13, wherein said anchor has a tubular shape with a longitudinal axis and has a diameter which varies along said longitudinal axis.

18. A method according to claim 13, wherein said distal end of said graft is secured to said anchor adjacent said proximal end of said anchor.

19. A method according to claim 13, wherein said anchor includes at least one hook segment secured adjacent said distal end of said anchor and having a proximal extension thereof, and wherein said distal end of said graft includes at least one hole;

and, wherein said proximal extension of said at least one hook segment projects through said at least one hole, securing said anchor to said graft.

20. A repair assembly for placement in a patient'"'"'s vascular system comprising:

a graft having a proximal end, a distal end and a generally tubular shape, said graft having at least one hole through a sidewall proximate to the distal end;

a self expanding anchor having a body and at least one hook segment extending from said body at a first location;

wherein said at least one hook segment extends through said hole in said graft and along the graft toward the distal end so that said distal end and a portion of said sidewall of said graft are captured between said hook segment and said body;

wherein said at least one hook segment is attached to said body at a second location so that said distal end and a portion of said sidewall are positioned between said first and second attachment locations.