Devices and methods for performing a vascular anastomosis

• US 6,682,541 B1
• Filed: 09/16/2002
• Issued: 01/27/2004
• Est. Priority Date: 02/24/1995
• Status: Expired due to Fees

• 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 O.
• Application Number:
  US10/244,366
• Time in Patent Office: 498 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. A method of forming an anastomosis for placing a lumen of a graft vessel in fluid communication with a lumen of a target vessel, the method comprising:

(a) forming an opening in a target vessel wall;

(b) passing at least a distal end of an anastomosis device through the opening in the target vessel wall, the anastomosis device comprising;

(i) a fastening flange having a reduced diameter and being expandable to an uncompressed diameter; and

(ii) a plurality of staple members extending from the fastening flange;

(c) bringing an end of the graft vessel proximate to the opening in the target vessel wall;

(d) engaging at least one of the graft vessel and the target vessel with the plurality of staple members; and

(e) expanding the fastening flange from the reduced diameter to the uncompressed diameter.

2. The method of forming an anastomosis according to claim 1, wherein the staple members are biased radially outward from a center of the fastening flange, and further comprising:

(f) constraining the staple members as the distal end of the anastomosis device is passed through the opening in the target vessel wall.

3. The method of forming an anastomosis according to claim 2, wherein (f) further comprises constraining the staple members radially inward towards a center of the fastening flange.

4. The method of forming an anastomosis according to claim 2, further comprising:

(g) allowing the staple members to deflect radially outward after at least a distal end of the anastomosis device passes through the opening in the target vessel wall.

5. The method of forming an anastomosis according to claim 2, wherein (f) comprises disposing a cap over the ends of the staple members.

6. The method of forming an anastomosis according to claim 5, further comprising:

(h) allowing the staple members to deflect radially outward after at least a distal end of the anastomosis device passes through the opening in the target vessel wall by axially displacing the cap from the ends of the staple members.

7. The method of forming an anastomosis according to claim 6, wherein (h) further comprises displacing the cap proximally from the ends of the staple members.

8. The method of forming an anastomosis according to claim 2, wherein the anastomosis device further comprises a shape-memory alloy, and (f) comprises deflecting the staple members radially inward while the anastomosis device is below the transition temperature of the shape-memory alloy.

9. The method of forming an anastomosis according to claim 8, further comprising:

(i) allowing the staple members to deflect radially outward after at least a distal end of the anastomosis device passes through the opening in the target vessel wall by allowing the temperature of the anastomosis device to exceed the transition temperature of the shape-memory alloy.

10. The method of forming an anastomosis according to claim 8, wherein the transition temperature of the shape-memory alloy is below body temperature.

11. The method of forming an anastomosis according to claim 2, wherein the anastomosis device further comprises a surface coating on at least a portion of the surface of the anastomosis device.

12. The method of forming an anastomosis according to claim 11, wherein the surface coating improves the biocompatability of the anastomosis device or reduces thrombosis.

13. The method of forming an anastomosis according to claim 2, wherein the anastomosis device further comprises one of a stainless steel alloy, a titanium alloy, and a cobalt alloy.