Devices and methods for performing avascular anastomosis

• US 6,984,238 B2
• Filed: 04/23/2004
• Issued: 01/10/2006
• 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 OWEN
• Application Number:
  US10/830,952
• Publication Number:
  US 20040199189A1
• Time in Patent Office: 627 Days
• Field of Search: 606/153, 606/154, 606/155, 606/156, 606/213, 606/216, 606/219, 606/220, 606/221
• US Class Current: 606/155
• 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 performing a procedure on a vessel having a previously made opening, the method comprising:

providing a device comprising a member having a longitudinal axis and an annular ring configured to be disposed about the member, the annular ring having at least two staple members extending therefrom, the at least two staple members each having a distal portion formed of an elastic material and ending in a sharpened point, the distal portions having a first configuration, where the at least two staple members are straight and the distal portions are separated by a first distance, and a second configuration, where the distal portions are separated by a second distance, the second distance being less than the first distance;

positioning the member at a location near the opening;

holding the distal portions of the at least two staple members in the first configuration with the member;

penetrating the sharpened points into tissue adjacent the opening; and

permitting the distal portions to move to the second configuration.

2. The method of claim 1, further comprising the step of moving the annular ring relative to the member.

3. The method of claim 2, wherein the annular ring is moved relative to the member by moving the annular ring from a first position to a second position located nearer to the opening.

4. The method of claim 3, wherein the device comprises a driver disposed about the member and further comprising the step of moving the driver to move the annular ring from the first position to the second position.

5. The method of claim 1, further comprising piercing the sharpened points through at least the outer wail of the vessel wall adjacent the opening.

6. The method of claim 5, further comprising piercing the sharpened points through the vessel wall and into the lumen of the vessel.

7. The method of claim 1, wherein the member is a tubular member.

8. The method of claim 1, wherein the distal portions of the staple members are formed of a superelastic material.

9. The method of claim 1, wherein the distal portions of the staple members are formed of a shape-memory material.

10. The method of claim 1, wherein the staple members are integrally formed with the annular ring.

11. The method of claim 1, wherein the first distance is greater than the at least one dimension of the opening.

12. The method of claim 11, wherein the first distance is greater than the diameter of the opening.

13. The method of claim 1, wherein the first distance and the second distance are measured in a plane perpendicular to the longitudinal axis.

14. The method of claim 1, wherein the distal portions of the staple members are substantially parallel to the longitudinal axis when the distal portions are in the first configuration.

15. The method of claim 1, wherein the distal portions of the staple members are not substantially parallel to the longitudinal axis when the distal portions are in the second configuration.

16. The method of claim 1, wherein at least the sharpened points are positioned radially inward relative to the annular ring when the distal portions are in the second configuration.

17. The method of claim 1, wherein the distal portions of the at least two staple members are substantially orthogonal to the longitudinal axis when the distal portions are in the second configuration.

18. The method of claim 1, wherein the distal portions of the at least two staple members form an acute angle with the respect to the longitudinal axis when the distal portions are in the second configuration.

19. The method of claim 1, further comprising the step of moving the member relative to the distal portions to permit at least the distal portions to move from the first configuration to the second configuration.

20. The method of claim 19, wherein the step of moving the member relative to the distal portions comprises moving the member in the direction parallel to the longitudinal axis away from the opening.

21. The method of claim 1, wherein the annular ring has a proximal portion, and at least the proximal portion is proximal to the tissue adjacent the opening when the distal portions are in the second configuration.

22. The method of claim 21, wherein the proximal portion comprises at least two proximal members each having a free end, and further comprising the steps of holding the proximal members in a first configuration substantially parallel to the longitudinal axis and permitting the proximal members to move to a second configuration where the free ends are located radially outward with respect to the longitudinal axis.

23. The method of claim 1, wherein at least a portion of the annular-shaped ring extends radially outward relative to the at least two staple members when the distal portions are in the second configuration.

24. A method of performing a procedure on a vessel having a previously made opening, the method comprising:

providing a device comprising a member having a longitudinal axis and an annular-shaped ring configured to be disposed about the member, the annular-shaped ring having at least two staple members extending therefrom, the at least two staple members each having a distal portion formed of an elastic material and ending in a sharpened point, the distal portions having a first configuration and a second configuration, where at least the distal portions are substantially orthogonal to the longitudinal axis;

positioning the member at a location near the opening;

holding the distal portions of the at least two staple members in the first configuration with the member;

penetrating the sharpened points into tissue adjacent the opening; and

permitting the distal portions to move to the second configuration.

25. The method of claim 24, further comprising the step of moving the annular ring relative to the member.

26. The method of claim 25, wherein the annular ring is moved relative to the member by moving the annular ring from a first position to a second position located nearer to the opening.

27. The method of claim 26, wherein the device comprises a driver disposed about the member and further comprising the step of moving the driver to move the annular ring from the first position to the second position.

28. The method of claim 24, further comprising piercing the sharpened points through at leant the outer wall of the vessel wall adjacent the opening.

29. The method of claim 28, further comprising piercing the sharpened points through the vessel wall and into the lumen of the vessel.

30. The method of claim 24, wherein the member is a tubular member.

31. The method of claim 24, wherein the distal portions of the staple members are formed of superelastic material.

32. The method of claim 24, wherein the distal portions of the staple members are formed of a shape-memory material.

33. The method of claim 24, wherein the staple members are integrally formed with the annular ring.

34. The method of claim 24, wherein the first distance is greater than the at least one dimension of the opening.

35. The method of claim 34, wherein the first distance is greater than the diameter of the opening.

36. The method of claim 24, wherein the first distance and the second distance are measured in a plane perpendicular to the longitudinal axis.

37. The method of claim 24, wherein the distal portions of the staple members are substantially parallel to the longitudinal axis when the distal portions are in the first configuration.

38. The method of claim 24, wherein the distal portions of the staple members are not substantially parallel to the longitudinal axis when the distal portions are in the second configuration.

39. The method of claim 24, wherein at least the sharpened points are positioned radially inward relative to the annular ring when the distal portions are in the second configuration.

40. The method of claim 24, wherein the staple members are straight when the distal portions are in the second configuration.

41. The method of claim 24, wherein the distal portions of the at least two staple members form an acute angle with the respect to the longitudinal axis when the distal portions are in the second configuration.

42. The method of claim 24, further comprising the step of moving the member relative to the distal portions to permit at least the distal portions to move from the first configuration to the second configuration.

43. The method of claim 42, wherein the step of moving the member relative to the distal portions comprises moving the member in the direction parallel to the longitudinal axis away from the opening.

44. The method of claim 24, wherein the annular-shaped ring has a proximal portion, and at least the proximal portion is proximal to the tissue adjacent the opening when the distal portions are in the second configuration.

45. The method of claim 44, wherein the proximal portion comprises at least two proximal members each having a free end, and further comprising the steps of holding the proximal members in a first configuration substantially parallel to the longitudinal and permitting the proximal members to move to a second configuration where the free ends are located radially outward with respect to the longitudinal axis.

46. The method of claim 24, wherein at least a portion of the annular-shaped ring extends radially outward relative to the at least two staple members when the distal portions are in the second configuration.

47. The method of claim 46, wherein the at least a portion of the annular-shaped ring extends substantially orthogonal to the longitudinal axis when the distal portions are in the second configuration.

48. A method of performing a procedure on a vessel having a previously made opening, the method comprising:

providing a device comprising a member having a longitudinal axis and an annular-shaped ring configured to be disposed about the member, the annular-shaped ring having at least two staple members extending therefrom, the at least two staple member, each having a distal portion formed of an elastic material and ending in a sharpened point, the distal portions having a first configuration, where the distal portions are separated by a first distance, and a second configuration, where the distal portions are separated by a second distance, the second distance being less than the first distance, and where at least a portion of the ring extends radially outward relative to the at least two staple members;

positioning the member at a location near the opening;

holding the distal portions of the at least two staple members in the first configuration with the member;

penetrating the sharpened points into tissue adjacent the opening; and

permitting the distal portions to move to the second configuration.

49. The method of claim 48, wherein the at least a portion of the annular-shaped ring extends substantially orthogonal to the longitudinal axis when the distal portions are in the second configuration.

50. The method of claim 48, wherein the annular-shaped ring has an inner diameter and an outer diameter, the distance measured between the inner diameter and the outer diameter being greater than the thickness of the distal portion of the at least two staple members.

51. The method of claim 48, further comprising the step of moving the annular ring relative to the member.

52. The method of claim 51, wherein the annular ring is moved relative to the member by moving the annular ring from a first position to a second position located nearer to the opening.

53. The method of claim 52, wherein the device comprises a driver disposed about the member and further comprising the step of moving the driver to move the annular ring from the first position to the second position.

54. The method of claim 48, further comprising piercing the sharpened points through at least the outer wall of the vessel wall adjacent the opening.

55. The method of claim 54, further comprising piercing the sharpened points through the vessel wall and into the lumen of the vessel.

56. The method of claim 48, wherein the member is a tubular member.

57. The method of claim 48, wherein the distal portions of the staple members are formed of a superelastic material.

58. The method of claim 48, wherein the distal portions of the staple members are formed of a shape-memory material.

59. The method of claim 48, wherein the staple members are integrally formed with the annular ring.

60. The method of claim 48, wherein the first distance is greater than the at least one dimension of the opening.

61. The method of claim 60, wherein the first distance is greater than the diameter of the opening.

62. The method of claim 48, wherein the first distance and the second distance are measured in a plane perpendicular to the longitudinal axis.

63. The method of claim 48, wherein the distal portions of the staple members are substantially parallel to the longitudinal axis when the distal portions are in the first configuration.

64. The method of claim 48, wherein the distal portions of the staple members are not substantially parallel to the longitudinal axis when the distal portions are in the second configuration.

65. The method of claim 48, wherein at least the sharpened points are positioned radially inward relative to the annular ring when the distal portions are in the second configuration.

66. The method of claim 48, wherein the staple members are straight when the distal portions are in the second configuration.

67. The method of claim 48, wherein the distal portions of the at least two staple members form an acute angle with the respect to the longitudinal axis when the distal portions are in the second configuration.

68. The method of claim 48, further comprising the step of moving the member relative to the distal portions to permit at least the distal portions to move from the first configuration to the second configuration.

69. The method of claim 68, wherein the step of moving the member relative to the distal portions comprises moving the member in the direction parallel to the longitudinal axis away from the opening.

70. The method of claim 48, wherein the annular-shaped ring has a proximal portion, and at least the proximal portion is proximal to the tissue adjacent the opening when the distal portions are in the second configuration.

71. The method of claim 70, wherein the proximal portion comprises at least two proximal members each having a free end, and further comprising the steps of holding the proximal members in a first configuration substantially parallel to the longitudinal axis and permitting the proximal members to move to a second configuration where the free ends are located radially outward with respect to the longitudinal axis.

72. The method of claim 48, wherein the distal portions of the at least two staple members are substantially orthogonal to the longitudinal axis when the distal portions are in the second configuration.