Devices and methods for performing a vascular anastomosis

• US 6,371,965 B2
• Filed: 01/08/2001
• Issued: 04/16/2002
• Est. Priority Date: 02/24/1995
• Status: Expired due to Term

• Current Assignee: Hanson S. Gifford III, Jeffrey A. Stein, Lee R. Bolduc, Paul C. Dicesare, Peter F. Costa, William A. Holmes
• Original Assignee: Hanson S. Gifford III, Jeffrey A. Stein, Lee R. Bolduc, Paul C. Dicesare, Peter F. Costa, William A. Holmes
• Inventors: Gifford, Hanson S. III, Stein, Jeffrey A., Bolduc, Lee R., Costa, Peter F., Holmes, William A., DiCesare, Paul C.
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/756,447
• Publication Number:
  US 20010001122A1
• Time in Patent Office: 463 Days
• Field of Search: 606/151-155, 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 17/11 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 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• 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 fitting 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 fitting comprising:

an inner flange having a proximal surface, a distal surface and a central orifice of sufficient size to accommodate an external diameter of said graft vessel, said inner flange providing an attachment for said graft vessel to the target vessel when said end of said graft vessel is positioned in the central orifice, said inner flange being insertable through said opening in said wall of said target vessel, wherein said inner flange has at least two operative positions, including a collapsed position wherein said inner flange has a collapsed diameter, and an expanded position wherein said inner flange has an expanded diameter which is greater than said collapsed diameter, the inner flange having a plurality of flange sectors which extend radially outward when expanded, the flange sectors engaging an inner wall of the lumen in the target vessel; and

an outer flange having a proximal surface, a distal surface and a central orifice coupled to the central orifice of the inner flange, said distal surface of said outer flange being configured to contact an exterior surface of said wall of said target vessel proximate said opening.

2. The anastomosis fitting of claim 1, wherein:

the plurality of flange sectors are a plurality of fingers which extend radially outward.

3. The anastomosis fitting of claim 2, wherein:

the plurality of fingers are naturally biased toward the expanded position.

4. The anastomosis fitting of claim 2, wherein:

the plurality of fingers are held in the collapsed position by a tubular tool which slides relative to the plurality of fingers, the tubular tool moving proximally to release the plurality of fingers to permit the fingers to move toward the expanded position.

5. The anastomosis fitting of claim 1, wherein:

the inner and outer flanges compress the target vessel therebetween.

6. The anastomosis fitting of claim 1, wherein:

the inner and outer flanges compress the target vessel without penetrating the target vessel.

7. A method of forming an anastomosis between a graft vessel and a target vessel, comprising the steps of:

providing an anastomosis device having an inner flange, an outer flange, and a central orifice therethrough, the inner flange having a proximal surface and a distal surface, the inner flange having at least two operative positions including a collapsed position wherein said inner flange has a collapsed diameter and an expanded position wherein said inner flange has an expanded diameter which is greater than said collapsed diameter, the inner flange having a plurality of flange sectors which extend radially outward when in the expanded position, the outer flange having a proximal surface and a distal surface;

positioning the graft in the central orifice;

holding the plurality of flange sectors in the collapsed position;

inserting the inner flange into the target vessel with the flange sectors in the collapsed position;

permitting the plurality of flange sectors to expand to the expanded position, wherein the inner flange contacts the inner wall of the graft vessel; and

compressing the target vessel between the inner and outer flanges.

8. The method of claim 7, wherein:

the providing step is carried out with the plurality of flange sectors being a plurality of fingers which extend radially outward.

9. The method of claim 8, wherein:

the providing step is carried out with the plurality of fingers being naturally biased toward the expanded position.

10. The method of claim 8, wherein:

the holding step is carried out with the plurality of fingers being held in the collapsed position by a tubular tool; and

the permitting step is carried out by sliding the tubular tool proximally to release the plurality of fingers and permit the fingers to move toward the expanded position.

11. The method of claim 7, wherein:

the compressing step is carried out without penetrating the target vessel with the inner and outer flanges.