Anastomosis device

• US 5,755,778 A
• Filed: 10/16/1996
• Issued: 05/26/1998
• Est. Priority Date: 10/16/1996
• Status: Expired due to Term

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: Nitinol Medical Technologies Incorporated
• Inventors: Kleshinski, Stephen J.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/733,139
• Time in Patent Office: 587 Days
• Field of Search: 623/1, 623/12, 606/153
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/006 modular

Abstract

A unitary anastomosis device for use in forming a graft between two body members is provided which includes a body member of fluid impervious vessel compatible material formed to define at least one elongate chamber having at least two spaced open ends. The outer surface of the body member carries a bio-adhesive which bonds the body member to the luminal walls of two vessels to be joined when the body member is expanded into contact with the vessel luminal walls.

Claims

1. An anastomosis device for use in forming a graft between two body vessels comprising:

a body member of fluid impervious body vessel compatible material formed to define at least one elongate chamber having at least two spaced open ends, said body member having an outer surface for engaging the luminal walls of said body vessels and

a bio-adhesive carried by the outer surface of said body member, said bio-adhesive including a two component adhesive which includes an adhesive initiator encapsulated on the outer surface of said body member which is released by pressure between said body member and said luminal walls.

2. The anastomosis device of claim 1 which includes a skeletal frame mounted inside said body member, said skeletal frame being operative to assume a first expanded configuration to force and hold said body member into contact with the luminal walls of said body vessels and a second collapsed configuration to collapse said skeletal frame and body member, said body member forming a flexible cover for said skeletal frame.

3. An anastomosis device for use in forming a graft between two body vessels comprising:

a body member of fluid impervious body vessel compatible material formed to define at least one elongate chamber having at least two spaced open ends, said body member having an outer surface for engaging the luminal walls of said body vessels,

a bio-adhesive carried by the outer surface of said body member,

a skeletal frame mounted inside said body member, the body member forming a flexible cover for said skeletal frame, the skeletal frame being operative to assume a first expanded configuration to force and hold said body member into contact with the luminal walls of said body vessels and a second collapsed configuration to collapse said skeletal frame and body member, said skeletal frame being formed of shape memory material having a temperature transformation level above which said skeletal frame assumes said first expanded configuration and below which said skeletal frame is collapsible to said second collapsed configuration.

4. The anastomosis device of claim 3 wherein said body member is formed of elastomeric material which contracts to collapse said skeletal frame to said second collapsed configuration when said skeletal frame is below said temperature transformation level.

5. The anastomosis device of claim 3 wherein said bio-adhesive includes a two component adhesive which includes an adhesive initiator encapsulated on the outer surface of said body member which is released by pressure between said body member and said luminal walls.

6. The anastomosis device of claim 3 wherein said bio-adhesive is a fibrin glue.

7. The anastomosis device of claim 3 wherein said bio-adhesive is a gelatin-formaldehyde-resorcinol glue.

8. The anastomosis device of claim 3 wherein said bio-adhesive is a photopolymerizing glue.

25. The anastomosis device of claim 3 wherein said bio-adhesive is an adhesive activated by contact with a body fluid.

9. An anastomosis device for use in forming a graft between two body vessels comprising:

a body member of fluid impervious body vessel compatible material formed to define at least one elongate chamber having at least two spaced open ends, said body member having an outer surface for engaging the luminal walls of said body vessels,

a bio-adhesive carried by the outer surface of said body member, a skeletal frame mounted inside said body member, said skeletal frame being operative to assume a first expanded configuration to force and hold said body member into contact with the luminal walls of said body vessels and a second collapsed configuration to collapse said skeletal frame and body member, said body member forming a flexible cover for said skeletal frame, said skeletal frame including laterally projecting barbs for engaging and penetrating the luminal walls of said body vessels when said skeletal frame is in said first expanded configuration.

10. An anastomosis device for use in forming a graft between two body vessels comprising:

a body member of fluid impervious body vessel compatible material formed to define at least one elongate chamber having at least two spaced open ends, said body member having an outer surface for engaging the luminal walls of said body vessels, said body member defining an elongate main leg defining a main elongate chamber having first and second open ends and a main longitudinal axis extending therebetween, and at least one branch leg secured to and extending angularly outward from said main leg, said branch leg including a first branch leg open end at said main leg opening into said main elongate chamber and a second branch leg open end spaced from said main leg with a branch leg longitudinal axis extending between said branch leg first and second open ends, and

a bio-adhesive carried by the outer surface of said body member.

11. The anastomosis device of claim 10 wherein said bio-adhesive includes a two component adhesive which includes an adhesive initiator encapsulated on the outer surface of said body member which is released by pressure between said body member and said luminal walls.

12. The anastomosis device of claim 10 wherein said bio-adhesive is a fibrin glue.

13. The anastomosis device of claim 10 wherein said bio-adhesive is a gelatin-formaldehyde-resorcinol glue.

14. The anastomosis device of claim 10 wherein said bio-adhesive is a photopolymerizing glue.

15. The anastomosis device of claim 10 which includes a skeletal frame mounted inside the main and branch legs of said body member, said skeletal frame being operative to assume a first expanded configuration to force and hold said main and branch legs of said body member into contact with the luminal walls of said body vessels and a second collapsed configuration to collapse said skeletal frame and body member, said body member forming a flexible cover for said skeletal frame.

16. The anastomosis device of claim 15 wherein said skeletal frame is formed of shape memory material having a temperature transformation level above which said skeletal frame assumes said first expanded configuration and below which said skeletal frame is collapsible to said second collapsed configuration.

17. The anastomosis device of claim 16 wherein said body member is formed of elastomeric material which contracts to collapse said skeletal frame to said second collapsed configuration when said skeletal frame is below said temperature transformation level.

18. The anastomosis device of claim 16 wherein said skeletal frame is formed to define said main elongate chamber within the main leg of said body and a branch elongate open ended chamber within the branch leg of said body, said skeletal frame including a main frame leg within the main leg of said body and a branch frame leg connected to said main frame leg and extending into the branch leg of said body,

said main frame leg being formed to define a plurality of interconnected open cells, each of which includes two substantially parallel, spaced straight side portions which are substantially parallel to said main longitudinal axis and end wall means extending between said side portions at an angle to said main longitudinal axis and

said branch frame leg being formed to define a plurality of interconnected open cells, each of which includes two substantially parallel, spaced straight side portions which are substantially parallel to said branch leg longitudinal axis and end wall means extending between said side portions at an angle to said branch longitudinal axis.

19. The anastomosis device of claim 18 wherein said skeletal frame is formed of shape memory material having a temperature transformation level above which said skeletal frame assumes said first expanded configuration and below which said skeletal frame is collapsible to said second collapsed configuration.

20. The anastomosis device of claim 19 wherein the skeletal main and branch legs of said skeletal frame include laterally projecting barbs for engaging and penetrating the luminal walls of said body vessels when said skeletal frame is in said first, expanded configuration.

21. The anastomosis device of claim 19 wherein the cells of said skeletal main and branch legs are joined together only along the lengths of said straight side portions.

22. The anastomosis device of claim 16 wherein said skeletal frame includes a main frame leg within the branch leg of said body, the temperature transformation level of said main frame leg being different from the temperature transformation level of said branch frame leg.

23. A device adapted to engage the luminal walls of a main body vessel and a branch body vessel extending from said main body vessel comprising:

a skeletal frame formed of shape memory material having an elongate main leg formed to define an elongate, open ended main chamber and a branch leg unitary with and extending angularly from said main leg and formed to define a branch chamber having a first open end opening into said main chamber and a second open end spaced therefrom,

the main and branch legs of said skeletal frame operating to expand from a collapsed configuration to a predetermined expanded configuration to engage the luminal walls of said body vessels, said skeletal frame being formed of thermal shape memory material which is relatively pliable at temperatures below a transition temperature to permit the skeletal frame to collapse to said collapsed configuration for insertion into said body vessels, said thermal shape memory material operating to expand from said collapsed configuration toward said expanded configuration when said skeletal frame is subjected to temperatures above said temperature transformation level to contact and apply force to said body vessels, the temperature transformation level of the shape memory material in the main leg of the skeletal frame differing from the temperature transformation level of the shape memory material in the branch leg of the skeletal frame.

24. The device of claim 23 wherein the temperature transformation level of the shape memory material in the main leg of the skeletal frame is lower than the temperature transformation level of the shape memory material in the branch leg of the skeletal frame.