Devices and methods for performing avascular anastomosis

• US 20030100910A1
• Filed: 01/09/2003
• Published: 05/29/2003
• Est. Priority Date: 02/24/1995
• Status: Active Grant

• 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.
• Granted Patent: US 7,112,211 B2
• Time in Patent Office: Days
• 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 staple 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 staple device comprising:

an anchor member, said anchor member having means for attaching said anchor member to said wall of said target vessel,

a coupling member, said coupling member being configured to attach said free end of said graft vessel to said coupling member, and

a coupling means for attaching said coupling member to said anchor member such that said end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

2. 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, said inner flange having a proximal surface and a distal surface and a central orifice of sufficient size to accommodate an external diameter of said graft vessel, said inner flange providing an atraumatic attachment for said end of said graft vessel when said end of said graft vessel is passed through said central orifice and everted over said inner flange, said inner flange being insertable through said opening in said wall of said target vessel,

an outer flange, said outer flange having a proximal surface and a distal surface and a central orifice of sufficient size to accommodate the external diameter of said graft vessel, said distal surface of said outer flange being configured to contact an exterior surface of said wall of said target vessel proximate said opening, and

means for maintaining said outer flange in a selected position with respect to said inner flange such that said everted end of said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.

3. The anastomosis fitting of claim 2, wherein said inner flange is configured such that the everted end of said graft vessel substantially covers at least said distal surface of said inner flange such that said inner flange is fluidly isolated from said lumen of said target vessel and said lumen of said graft vessel

4. The anastomosis fitting of claim 2, further comprising a tubular body having a proximal end and a distal end, said inner flange being connected to said distal end, said tubular body having a central lumen of sufficient size to accommodate an external diameter of said graft vessel.

5. The anastomosis fitting of claim 4 wherein a proximal portion of said tubular body is configured to be slidably received in said central orifice of said outer flange, and said means for maintaining said outer flange in a selected position with respect to said inner flange comprises a locking means for locking said outer flange to said tubular body.

6. The anastomosis fitting of claim 5 wherein said locking means comprises a self-locking retaining washer slidably positioned on an exterior surface of said tubular body.

7. The anastomosis fitting of claim 3 wherein said outer flange is deformable from an initial configuration wherein said distal surface of said outer flange does not contact said exterior surface of said wall of said target vessel to a deployed configuration wherein said distal surface of said outer flange contacts said exterior surface of said wall of said target vessel.

8. The anastomosis fitting of claim 2 wherein said means for maintaining said outer flange in a selected position with respect to said inner flange comprises a deformable means for connecting said outer flange to said inner flange, whereby said deformable means can be deformed to position and hold said outer flange in a selected position with respect to said inner flange.

9. The anastomosis fitting of claim 2 wherein said outer flange is divided into a plurality of flange sectors, each of said flange sectors being connected to said inner flange by way of at least one deformnable means.

10. The anastomosis fitting of claim 9 wherein said deformable means is connected to said inner flange by way of a tubular body, said tubular body having a central lumen of sufficient size to accommodate an external diameter of said graft vessel.

11. The anastomosis fitting of claim 2 wherein said outer flange comprises a tubular body connected to said inner flange, said tubular body being deformable from an undeformed configuration to an expanded configuration to form said outer flange.

12. The anastomosis fitting of claim 11 wherein said tubular body is divided into a plurality of longitudinal segments, said longitudinal segments being predisposed to expand outward when compressed axially.

13. The anastomosis fitting of claim 2, 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.

14. The anastomosis fitting of claim 13, wherein said inner flange comprises a plurality of flange sectors, said flange sectors being collapsed toward one another to occupy a diameter equal to said collapsed diameter when said inner flange is in said collapsed position and said flange sectors being expandable away from one another to occupy a diameter equal to said expanded diameter when said inner flange is in said expanded position.

15. The anastomosis fitting of claim 14, further comprising an expansion means for expanding said inner flange from said collapsed position to said expanded position.

16. The anastomosis fitting of claim 15, wherein said expansion means comprises a tubular member which, when inserted into said central orifice between said flange sectors, forces said flange sectors from said collapsed position to said expanded position.

17. The anastomosis fitting of claim 2, wherein said inner flange comprises a plurality of initially longitudinally oriented segments, said segments being configured to expand radially in response to being compressed axially.

18. The anastomosis fitting of claim 17, wherein said initially longitudinally oriented segments have a proximal end which is connected to said outer flange and a distal end, said segments being configured to expand radially when said distal end is compressed axially toward said proximal end.

19. The anastomosis fitting of claim 18, wherein said segments have a curved portion intermediate said proximal end and said distal end predisposing said segments to expand radially when said distal end is compressed axially toward said proximal end.

20. A method of performing an anastomosis to connect 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 method comprising:

attaching said free end of said graft vessel to an inner flange of an anastomotic fitting;

inserting said inner flange with said free end of said graft vessel attached through said opening in said wall of said target vessel and engaging an inner surface of said target vessel with said inner flange;

positioning an outer flange of said anastomostic fitting in contact with an exterior surface of said wall of said target vessel proximate said opening; and

coupling said inner flange and said outer flange such that said graft vessel is sealingly connected to said wall of said target vessel and said lumen of said graft vessel is in fluid communication with said lumen of said target vessel through said opening in said wall of said target vessel.