Devices and methods for performing a vascular anastomosis

• US 5,817,113 A
• Filed: 01/23/1997
• Issued: 10/06/1998
• Est. Priority Date: 02/24/1995
• Status: Expired due to Term

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Gifford, Hanson S. III, Stein, Jeffrey A., Bolduc, Lee R., Costa, Peter F., Holmes, William A., DiCesare, Paul C.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US08/789,327
• Time in Patent Office: 621 Days
• Field of Search: 606/139, 606/151, 606/152, 606/153, 606/154, 606/155, 606/184, 606/185, 606/213, 606/219, 606/220
• US Class Current: 606/153
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

A system for performing an end-to-side vascular anastomosis, including an anastomosis device, an application instrument and methods for performing a vascular anastomosis. The system is applicable for performing an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly in port-access CABG surgery. A first aspect of the invention includes a vascular anastomosis staple. A first configuration has two parts: an anchor member, forming the attachment with the target vessel wall and a coupling member, forming the attachment with the bypass graft vessel. The anastomosis is completed by inserting the coupling member, with the graft vessel attached, into the anchor member. A second configuration combines the functions of the anchor member and the coupling member into a one-piece anastomosis staple. A second aspect of the invention includes an anastomotic fitting, having an inner flange over which the graft vessel is everted and an outer flange which contacts the exterior surface of the target vessel. A tailored amount of compression applied by the inner and outer flanges grips the target vessel wall and creates a leak-proof seal between the graft vessel and the target vessel. A third aspect of the invention has a flange to which the graft vessel attaches, by everting the graft vessel over the flange, and a plurality of staple-like members which attach the flange and the everted end of the graft vessel to the wall of the target vessel to form the anastomosis.

Claims

1. An anastomosis device for connecting a free end of a graft vessel to a wall of a target vessel such that a lumen in the graft vessel is in fluid communication with a lumen in the target vessel through an opening in the wall of the target vessel, the anastomosis device comprising:

a fastening flange, said fastening flange having a distal surface and a central orifice of sufficient size to accommodate an external diameter of said graft vessel, said fastening flange providing an attachment for said end of said graft vessel by passing said end of said graft vessel through said central orifice and everting said end of said graft vessel over said fastening flange,

and a plurality of separate staple members slidably movable with respect to said fastening flange, said staple members being configured to pierce the everted end of said graft vessel and to penetrate the wall of said target vessel thereby attaching said fastening flange and the everted end of said graft vessel to the wall of said target vessel.

2. The anastomosis device of claim 1 wherein said fastening flange has a plurality of holes through said fastening flange, said holes communicating with said distal surface of said fastening flange, said staple members being slidably received within said holes.

3. The anastomosis device of claim 2 wherein each of said staple members has a preset curve, said preset curve being constrained in an approximately straight configuration by said holes when positioned therein, said preset curve resuming a curved configuration when said preset curve is positioned outside of said holes.

4. The anastomosis device of claim 3 wherein said preset curve of said staple members disposes a distal portion of said staple members to curve outward beyond an outer diameter of said fastening flange when said preset curve is positioned outside of said holes.

5. The anastomosis device of claim 3 wherein said staple members are made of a resilient material which biases said staple members toward the preset curved configuration.

6. The anastomosis device of claim 5 wherein said resilient material is a superelastic nickel-titanium alloy.

7. The anastomosis device of claim 2 wherein each of said staple members has a proximal segment, a curved segment connected to said proximal segment and a distal tip connected to said curved segment, said curved segment being configured to orient said distal tip to penetrate an interior surface of the target vessel wall.

8. The anastomosis device of claim 7 wherein said distal tip of said staple member is configured to traverse the wall of the target vessel from the interior surface to an exterior surface of the target vessel and said anastomosis device further comprises means for coupling said distal tip to said fastening flange.

9. The anastomosis device of claim 8 wherein said means for attaching said distal tip to said fastening flange comprises a barb attached to said distal segment, said barb being configured to engage a ridge on said fastening flange.

10. The anastomosis device of claim 8 wherein said means for attaching said distal tip to said fastening flange comprises a locking cap couplable to said fastening flange having means to fasten said distal tip to said fastening flange.

11. The anastomosis device of claim 7 wherein said staple members are rotatable within said holes in said fastening flange to an insertion position wherein said curved segment and said distal segment are within a circle defined by an external diameter of said fastening flange to facilitate insertion of said curved segment and said distal segment through the opening in the wall of the target vessel.

12. The anastomosis device of claim 11 wherein said staple members are rotatable to a second position wherein said curved segment and said distal segment extend outward from the circle defined by the external diameter of said fastening flange.

13. The anastomosis device of claim 1 wherein each of said staple members has at least one attachment leg, said attachment leg having an approximately straight central segment, a proximal segment which makes an acute angle with respect to said central segment and a distal segment which makes an acute angle with respect to said central segment.

14. The anastomosis device of claim 13 wherein said attachment leg is configured so that said proximal segment of said attachment leg bears against a proximal surface of said fastening flange and said distal segment of said attachment leg bears against an interior surface of the wall of the target vessel, thereby attaching said fastening flange to the wall of said target vessel.

15. The anastomosis device of claim 14 wherein said attachment leg is made of a resilient material having an elastic memory which biases said proximal segment against said proximal surface of said fastening flange and which biases said distal segment of said attachment leg against said interior surface of the wall of the target vessel.

16. The anastomosis device of claim 13 wherein each of said plurality of staple members comprises two attachment legs, the proximal segments of said two attachment legs being attached together.

17. The anastomosis device of claim 16 wherein said fastening flange has a plurality of holes through said fastening flange, said holes communicating with said distal surface of said fastening flange, said holes being arranged in pairs to allow the two attachment legs of said staple members to be slidably received therein.

18. The anastomosis device of claim 1 wherein each of said staple members has at least one attachment leg, said attachment leg having a proximal segment and a deformable distal segment, said proximal segment being stiffer than said distal segment to resist deformation of said proximal segment.

19. The anastomosis device of claim 18 wherein said staple members are configured such that said distal segment is deformable to a position wherein said distal segment bears against an interior surface of said wall of said target vessel.

20. The anastomosis device of claim 1 wherein each of said staple members has two attachment legs, each of said attachment legs having a proximal segment and a deformable distal segment, said proximal segment being stiffer than said distal segment to resist deformation of said proximal segment, the proximal segments of said two attachment legs being attached together.

21. The anastomosis device of claim 20 wherein said proximal segment includes a stiffening means comprising a tubular member which encircles and reinforces said proximal segment.

22. The anastomosis device of claim 20 wherein said proximal segment has a greater cross sectional area than said distal segment.

23. The anastomosis device of claim 1, wherein when said staple members are made of a superelastic metal alloy.

24. The anastomosis device of claim 1, further comprising a plurality of outer attachment legs connected to said fastening flange, said outer attachment legs being configured to penetrate an exterior surface of said target vessel.

25. The anastomosis device of claim 24, wherein said outer attachment legs are deformable from a first position wherein said attachment legs do not contact said target vessel and a second position wherein said attachment legs penetrate said exterior surface of said target vessel.

26. The anastomosis device of claim 1, further comprising an outer flange having a distal surface configured to contact an exterior surface of said target vessel.

27. The anastomosis device of claim 26, further comprising a locking means for locking said outer flange in a selected position with respect to said fastening flange.

28. The anastomosis device of claim 27, wherein said locking means comprises a self-locking retaining washer having a central orifice slidably received on a tubular extension extending proximally from said fastening flange.

29. The anastomosis device of claim 1, wherein at least said central orifice of said fastening flange has a geometry selected from the group consisting of circular, elliptical, oval, and teardrop-shaped.

30. An improved tissue punch of the type having an anvil axially movable with respect to a tubular cutter, said anvil being configured to be slidably received within an internal lumen of said tubular cutter to punch a hole through tissue interposed between said anvil and said tubular cutter, wherein the improvement comprises:

a clamping member coupled to said tissue punch for clamping the tissue to be cut by said tissue punch, the clamping member and the anvil being relatively movable with respect to each other.

31. The improved tissue punch of claim 30 wherein said clamping member is slidably received within said internal lumen of said tubular cutter, and wherein said clamping member has a distal surface opposing a proximal surface of said anvil wherein said tissue is clamped between said distal surface and said proximal surface.

32. The improved tissue punch of claim 30 further comprising a stapling mechanism coupled to said tissue punch, said stapling mechanism being configured to apply at least one staple to tissue surrounding said tissue punch which is clamped by said clamping member.