Sutureless closure and deployment system for connecting blood vessels

• US 6,428,550 B1
• Filed: 05/18/1999
• Issued: 08/06/2002
• Est. Priority Date: 05/18/1999
• Status: Expired due to Term

• Current Assignee: Aesculap AG (Lonza Group AG)
• Original Assignee: Cardica Incorporated
• Inventors: Yencho, Stephen A., Hausen, Bernard A., Hendricksen, Michael, Vargas, Jaime, Nielsen, Jamey
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/314,278
• Time in Patent Office: 1,176 Days
• Field of Search: 606/153, 606/152, 606/198, 606/107, 606/154, 606/155, 606/158, 623/1
• US Class Current: 606/153
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• 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 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

An anastomosis device is a one piece device for connecting a graft vessel to a target vessel without the use of conventional sutures. The anastomosis device includes an expandable tube configured to have a graft vessel secured to the tube. The device has an expandable linkage positioned at one end of the device and expansion of this linkage causes a first radially extending flange to fold outward. This first flange abuts an interior wall of a target vessel and a second flange is formed which abuts an exterior wall of the target vessel trapping the target vessel between the two flanges and secures the end of the graft vessel into an opening in the wall of the target vessel. The device greatly increases the speed with which anastomosis can be performed over known suturing methods and allows anastomosis to be performed in tight spaces.

Claims

1. An anastomosis device for connecting a graft vessel to a target vessel, the device comprising:

a first linkage formed of a plurality of struts, the first linkage expandable from a first configuration in which the first linkage is a substantially tubular shape to a second configuration in which the first linkage includes a first outwardly extending flange;

a substantially tubular connecting portion extending from the first linkage;

a second linkage extending from the connecting portion and configured to form a second outwardly extending flange spaced from the first outwardly extending flange; and

said outwardly extending flange of said first linkage being formed in response to a radial expansion of said tubular connecting portion.

2. The anastomosis device of claim 1, wherein the first linkage includes a plurality of axial members each including a hinge for concentrating bending of the axial members during formation of the first outwardly extending flange.

3. The anastomosis device of claim 1, wherein the plurality of struts form a plurality of diamond shapes which contract in an axial direction of the device when the device is outwardly expanded.

4. The anastomosis device of claim 3, wherein the first linkage includes a plurality of axial members, and wherein the plurality of axial members are each positioned within a corresponding one of the diamond shapes such that as the diamond shapes contract in the axial direction the axial members bend outward to form the first outwardly extending flange.

5. The anastomosis device of claim 1, wherein the first linkage includes a plurality of axial members, and wherein the plurality of axial members are inner diamond shaped members connected to the plurality of struts at top and bottom corners and including two hinges at side corners.

6. The anastomosis device of claim 1, wherein the second linkage is formed of a plurality of struts and a plurality of axial members, and the second linkage is expandable from a first configuration in which the second linkage is a substantially tubular shape to a second configuration in which the second linkage forms the second outwardly extending flange.

7. The anastomosis device of claim 1, wherein the second linkage is formed of a plurality of pull tabs configured for holding the anastomosis device during insertion.

8. The anastomosis device of claim 1, wherein the first outwardly extending flange is conical.

9. The anastomosis device of claim 1, wherein the second outwardly extending flange is conical.

10. An anastomosis device for connecting a graft vessel to a target vessel, the device comprising:

a body formed from a plurality of struts and deformable from a first configuration in which the device is substantially tubular to a second configuration in which the device includes a first flange and a second flange spaced from the first flange, wherein the body includes a substantially tubular connecting portion between the first flange and the second flange, and said first flange is formed in response to a radial expansion of said tubular connecting portion.

11. The anastomosis device of claim 10, wherein:

a first end of the body includes a first linkage which changes from a substantially tubular configuration to an outwardly extending configuration to form the first flange upon radial expansion of the first end by an expander positioned in a center of the body; and

a second end of the body includes a second linkage which is configured to form the second flange upon deployment of the device.

12. The anastomosis device of claim 11, wherein the first linkage includes a plurality of struts arranged in a configuration such that an axial dimension of the first linkage changes upon outwardly expansion of the linkage.

13. The anastomosis device of claim 12, wherein the first linkage includes a plurality of folding members which are caused to fold outward by the change in axial dimension of the first linkage.

14. The anastomosis device of claim 13, wherein the folding members are axially members with central hinges.

15. The anastomosis device of claim 13, wherein the folding members are diamond shaped members having two central hinges.

16. The anastomosis device of claim 11, wherein the first linkage includes a plurality of members which are caused to fold outward tangentially to the device by the change in the axial dimension of the first linkage.

17. The anastomosis device of claim 10, wherein the first and second flanges each form an angle between about 45 and 100 degrees with an axis of the body.

18. The anastomosis device of claim 10, wherein the first flange is formed by outwardly pivoting a plurality of substantially axial members which are supported by the plurality of struts.

19. The anastomosis device of claim 10, wherein the first flange and the second flange are spaced apart a distance sufficient to accommodate a wall of a blood vessel.

20. An anastomosis device, comprising:

an expandable body and configured to allow fluid flow therethrough; and

a first flange extending from the body, wherein mechanical expansion of a portion of said body causes said first flange to extend outwardly from said body and

a second flange extending from the body and spaced apart from the first flange.

21. The anastomosis device of claim 20, wherein the first flange is formed by outwardly expanding a four bar linkage which is provided on said body.

22. The anastomosis device of claim 21, wherein the four bar linkage is formed by a plurality of struts arranged in a plurality of interconnected substantially diamond shapes.

34. The anastomosis device of claim 20, further comprising a second flange extending from the body.

23. An anastomosis device comprising a body having elements which form moveable linkages, said body configured to allow fluid flow therethrough, wherein mechanical expansion of said body activates said linkages to form a first flange and wherein mechanical expansion of another portion of the body forms a second flange.

24. The anastomosis device of claim 23, wherein the movable linkages include hinges and wherein expansion of the body causes the hinges to bend to form the flange.

25. The anastomosis device of claim 23, wherein the flange is formed at a distal end of the body and a proximal flange is formed at a proximal end of the body.

26. The anastomosis device of claim 25, wherein the second flange is formed of a plurality of pull tabs configured for holding the body during insertion.

27. An anastomosis device for connecting a graft vessel to a target vessel, the device comprising:

a substantially tubular expandable body configured to allow fluid flow therethrough;

a pair of spaced apart flanges extending from said body for holding the tissue of the target vessel between said flanges; and

at least one of said flanges being formed in response to a radial expansion of said substantially tubular expandable body.

28. The device of claim 27, wherein the flanges are each formed from a portion of the substantially tubular expandable body which is folded outward.

29. The device of claim 28, wherein the flanges are folded outward in opposite directions.

30. The device of claim 27, wherein the pair of spaced apart flanges are positioned on a proximal most and a distal most portion of the substantially tubular expandable body.

31. The device of claim 27, wherein the substantially tubular expandable body is radially expandable from a first diameter to a second larger diameter for supporting tissue of the target vessel at an anastomosis site.

32. The device of claim 27, wherein the pair of spaced apart flanges are deployed to grasp the tissue of the target vessel between the flanges.

33. The device of claim 32, wherein an inner one of the pair of spaced apart flanges is configured to be deployed first and an outer one of the pair of spaced apart flanges is configured to be deployed second to grasp the tissue of the target vessel between the flanges.

35. An anastomosis device for connecting a graft vessel to a target vessel, the device comprising

a substantially tubular expandable body configured to allow fluid flow therethrough;

a pair of spaced apart flanges extending from the body for holding the tissue of the target vessel between the flanges; and

at least one of the flanges being formed by a force acting through the substantially tubular expandable body which causes the flange to expand.

36. The anastomosis device of claim 35, wherein the flanges are each formed from a portion of the substantially tubular expandable body which is folded outward.

37. The anastomosis device of claim 35, wherein an inner one of the pair of spaced apart flanges is configured to be deployed first and an outer one of the pair of spaced apart flanges is configured to be deployed second to grasp the tissue of the target vessel between the flanges.