Apparatus and method for engrafting a blood vessel

• US 5,713,917 A
• Filed: 09/18/1996
• Issued: 02/03/1998
• Est. Priority Date: 10/30/1995
• Status: Expired due to Term

• Current Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Original Assignee: Howard J. Leonhardt, Syde A. Taheri, Trevor Greenan
• Inventors: Greenan, Trevor, Leonhardt, Howard J., Taheri, Syde A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/710,460
• Time in Patent Office: 503 Days
• Field of Search: 606/192, 606/193, 606/194, 606/195, 606/198, 623/1, 623/12
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• 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 2/954 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 2002/061 provided with means for allowing access to secondary lumens
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An apparatus and method for engrafting a blood vessel are disclosed. The apparatus includes a tubular graft having radially compressible annular spring portions for biasing proximal and distal ends of the graft into conforming fixed engagement with an interior surface of the vessel, with bifurcated and adjustable length embodiments being disclosed. Apparatus for deploying the graft includes an insertion catheter having a nitinol core wire, a controllable tip balloon at a remote end thereof for dilation and occlusion of the vessel, and a controllable graft balloon in the vicinity of the tip balloon for fixedly seating the spring portions into conformance with the interior surface of the vessel. A spool apparatus for adjusting or removing an improperly placed graft, and a micro-emboli filter tube, are usable with the deployment apparatus. A method of percutaneously implanting a graft, including a single-entry method for percutaneously implanting a bifurcated graft, are also disclosed.

Claims

1. An apparatus for engrafting a blood vessel comprising:

a tubular graft of bio-compatible graft material for conducting fluid, said graft being capable of substantially deforming so as to conform to an interior surface of said blood vessel, said graft having proximal and distal opposite ends;

radially compressible spring means for biasing said proximal and distal ends thereof radially outward into conforming fixed engagement with said interior surface of said blood vessel;

said graft material being attached to said spring means and enclosing said spring means to prevent contact between said spring means and said interior surface of said vessel.

2. The apparatus according to claim 1, wherein said graft includes a middle portion extending between said proximal and distal ends, and said graft material is tapered to define a smaller fluid conducting area through said middle portion.

3. The apparatus according to claim 2, further comprising at least one medical-grade expandable foam cuff surrounding said middle portion.

4. The apparatus according to claim 1, wherein said spring means is a wire spring comprising a pair of annular spring portions spaced apart along a central axis for location at said proximal and distal ends of said graft, and at least one connecting bar extending between said spring portions for connecting said pair of spring portions to one another.

5. The apparatus according to claim 4, wherein said connecting bar is arranged to extend generally parallel to said central axis.

6. The apparatus according to claim 4, wherein each of said annular spring portions comprises a continuous zig-zag pattern of straight spokes connected by alternating crests and troughs, and said crests and troughs are of a predetermined radius.

7. The apparatus according to claim 6, wherein said graft material is cut out between said crests of at least one of said pair of spring portions to define a plurality of radially distensible finger portions.

8. The apparatus according to claim 7, further comprising a radially compressible anchor spring aligned generally on said central axis for fixing said graft within said blood vessel remotely of said proximal and distal ends of said graft.

9. The apparatus according to claim 8, wherein said anchor spring comprises a first annular spring portion attached to said graft material between said proximal and distal ends of said graft, and a second annular spring portion outside of said proximal and distal ends, said first and second spring portions being connected by at least one connecting bar extending generally parallel to said central axis.

10. The apparatus according to claim 1, further including tissue adhesive means associated with said proximal and distal ends of said graft for bonding said graft to said interior surface of said blood vessel and forming a substantially fluid-tight seal therebetween.

11. The apparatus according to claim 10, wherein said tissue adhesive means comprises a plurality of packets including a degradably photo-sensitive outer packet material enclosing a tissue adhesive, whereby said tissue adhesive may be released by directing a beam of light at said packets.

12. The apparatus according to claim 11, wherein said tissue adhesive substance is fibrin glue.

13. The apparatus according to claim 11, wherein said tissue adhesive substance is isobutyl 2 cyanoacrylate.

14. An apparatus for engrafting a bifurcated blood vessel comprising:

a tubular graft of bio-compatible graft material for conducting fluid, said graft being capable of substantially deforming so as to conform to an interior surface of said blood vessel, said graft including a primary limb having proximal and distal opposite ends, an ipsilateral limb having proximal and distal opposite ends, and a contralateral limb having proximal and distal opposite ends, said proximal ends of said ipsilateral and contralateral limbs joining with said distal end of said primary limb for flow communication therewith to form a bifurcated fluid conduit;

radially compressible spring means for biasing said proximal and distal ends of said primary, ipsilateral, and contralateral limbs radially outward into conforming fixed engagement with said interior surface of said blood vessel;

said graft material being attached to said spring means and enclosing said spring means to prevent contact between said spring means and said interior surface of said blood vessel.

15. The apparatus according to claim 14, wherein said primary, ipsilateral, and contralateral limbs each include a middle portion extending between said proximal and distal ends thereof, and said graft material is tapered to define a smaller fluid conducting area through said middle portions.

16. The apparatus according to claim 15, further comprising at least one medical-grade expandable foam cuff surrounding said middle portion of said primary limb.

17. The apparatus according to claim 14, wherein said spring means comprises a plurality of wire springs associated one to each of said primary, ipsilateral, and contralateral limbs, each said wire spring having a proximal annular spring portion disposed at a proximal end of its associated limb and a distal annular spring portion disposed at a distal end of said associated limb, and at least one connecting bar extending between said spring portions for connecting said spring portions to one another.

18. The apparatus according to claim 17, wherein said at least one connecting bar is arranged to extend generally parallel to a central axis of said associated limb.

19. The apparatus according to claim 17, further comprising means for releasably retaining said distal spring portion of said contralateral limb in a radially compressed condition.

20. The apparatus according to claim 19, wherein said retaining means is an expandable retainer ring formed of suture material.

21. The apparatus according to claim 17, wherein each of said annular spring portions comprises a continuous zig-zag pattern of straight spokes connected by alternating crests and troughs, and said crests and troughs are of a predetermined radius.

22. The apparatus according to claim 21, wherein said graft material is cut out between said crests of said spring portion at said proximal end of said primary limb to define a plurality of radially distensible finger portions.

23. The apparatus according to claim 22, wherein said graft material is cut out between said crests of said spring portions at said distal ends of said ipsilateral and contralateral limbs to define a plurality of radially distensible finger portions.

24. The apparatus according to claim 14, further including tissue adhesive means associated with said proximal end of said primary limb for bonding said graft to said interior surface of said blood vessel and forming a substantially fluid-tight seal therebetween.

25. The apparatus according to claim 24, wherein said tissue adhesive means comprises a plurality of packets including a degradably photo-sensitive outer packet material enclosing a tissue adhesive, whereby said tissue adhesive may be released by directing a beam of light at said packets.

26. An apparatus for engrafting a blood vessel comprising:

a tubular graft of bio-compatible graft material for conducting fluid, said graft being capable of substantially deforming so as to conform to an interior surface of said blood vessel, said graft including a mating portion having proximal and distal opposite ends and an adjustable length portion having proximal and distal opposite ends, said proximal end of said adjustable length portion being arranged adjacent to said distal end of said mating portion such that said mating and adjustable length portions extend along a common central axis; and

radially compressible spring means for biasing said proximal end of said mating portion radially outward into conforming fixed engagement with an interior surface of another graft to which said apparatus is mated, and for biasing said distal end of said mating portion, said proximal end of said adjustable length portion, and said distal end of said adjustable length portion radially outward into conforming fixed engagement with said interior surface of said blood vessel, said spring means comprising a first annular spring portion associated with said proximal end of said mating portion, a second annular spring portion associated with said distal end of said mating portion and said proximal end of said adjustable length portion, said second spring portion being connected to said first spring portion by at least one connecting bar, and a third annular spring portion associated with said distal end of said adjustable length portion;

said graft material being attached to said spring means and enclosing said spring means to prevent contact between said spring means and said interior surface of said blood vessel, and said graft material being crimped along a length of said adjustable length portion, such that said third spring portion is axially movable relative to said second spring portion to adjust the length of said graft.

27. The apparatus according to claim 26, wherein said first and third spring portions comprise a continuous zig-zag pattern of straight spokes connected by alternating crests and troughs, and said graft material is cut out between said crests of said first and third spring portions to define a plurality of radially distensible finger portions.

28. The apparatus according to claim 26, further comprising retainer means for releasably retaining said third spring portion in a radially compressed condition.