Medical grafting methods and apparatus

• US 8,109,947 B2
• Filed: 06/27/2005
• Issued: 02/07/2012
• Est. Priority Date: 11/06/1998
• Status: Expired due to Fees

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Berg, Todd A, Sullivan, Daniel J, Swanson, William J, Hindrichs, Paul J
• Primary Examiner(s): Nguyen, Tuan
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US11/169,114
• Publication Number:
  US 20050240205A1
• Time in Patent Office: 2,416 Days
• Field of Search: 606/153, 604/8
• US Class Current: 606/153
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• 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 Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient'"'"'s existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is installed at the operative site primarily by providing at least one graft location with instrumentation inserted through the patient'"'"'s existing tubular body organ structure. Assistance in installing the new tubing may be provided by minimally invasive surgical access openings in the patient'"'"'s chest. The tubing may be delivered through the patient'"'"'s existing tubular body structure or, alternatively, through the surgical access openings.

Claims

1. A method for installing a tubular graft between first and second spaced locations in a patient'"'"'s tubular body structure comprising:

providing a first aperture through a wall of the tubular body structure at the first location with a distal portion of an elongated structure inserted into and along a lumen of the tubular body structure to the first location;

providing a surgical access opening in the patient adjacent one of the first and second locations;

inserting an elongated guide member having first and second end portions through the surgical access opening;

moving the second end portion of the elongated guide member into the tubular body structure by piercing the tubular body structure at the second location;

moving the first end portion of the elongated guide member into the tubular body structure via the first aperture;

passing the graft along the lumen of the tubular body structure and over and around an outside of the elongated guide member, through the wall at one of the first and second locations to the other of the locations; and

attaching axially spaced portions of the graft to the tubular body structure adjacent the first and second locations.

2. The method defined in claim 1, wherein the step of moving one of the end portions of the elongated guide member comprises:

accessing the elongated guide member with instrumentation inserted into the surgical access opening.

3. The method defined in claim 1, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises forming anastomotic connections between the graft and the tubular body structure so that the patient'"'"'s body fluid can flow between the lumen of the tubular body structure and the interior of the graft.

4. The method defined in claim 3, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises forming an anastomotic connection between an end of the graft and the first aperture in the wall of the tubular body structure.

5. The method defined in claim 1, wherein the distal portion of the elongated structure has a sharpened portion, and the step of providing the first aperture through the tubular body structure at the first location with the distal portion of the elongated structure comprises:

piercing the tubular body structure at the first location with the sharpened portion of the elongated structure.

6. The method defined in claim 5, wherein the distal portion of the elongated structure has a substantially hollow configuration, and the step of providing the first aperture through the tubular body structure at the first location with the distal portion of the elongated structure comprises:

extending the distal portion of the elongated structure out of the first aperture of the tubular body structure at the first location such that a fluid-tight seal is provided between the distal portion of the elongated structure and the first aperture.

7. The method defined in claim 6, wherein the step of moving the first end portion of the elongated guide member into the tubular body structure via the first aperture at the first location comprises:

inserting the first end portion of the elongated guide member into the hollow distal portion of the elongated structure and along the interior of the elongated structure.

8. The method defined in claim 7 wherein the graft has first and second end portions and the method further comprises:

before the step of passing the graft along the lumen of the tubular body structure, attaching a connector to one of the end portions of the graft.

9. The method defined in claim 8 wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

attaching one of the end portions of the graft to the tubular body structure with the connector.

10. The method defined in claim 9 wherein the step of attaching one of the end portions of the graft to the tubular body structure with the connector comprises:

providing a graft installing structure associated with an end portion of the graft and having a dilating portion;

making a second aperture at the second location with the graft installing structure; and

enlarging the second aperture with the dilating portion.

11. The method defined in claim 10 wherein the step of attaching one of the end portions of the graft to the tubular body structure with the connector comprises:

inserting a portion of the connector into the second aperture; and

expanding a portion of the connector in the second aperture.

12. The method defined in claim 9 wherein the step of attaching one of the end portions of the graft to the tubular body structure with the connector comprises:

retracting the distal portion of the elongated structure into the lumen of the tubular body structure;

inserting a portion of the connector into the first aperture; and

expanding a portion of the connector in the first aperture.

13. The method defined in claim 1 further comprising:

before the step of moving the second end portion of the elongated guide member, passing a radiopaque marker into and along the lumen of the tubular body structure to the second location to provide a visual aid to the step of moving the second end portion of the elongated guide member into the tubular body structure at the second location.

14. The method defined in claim 1, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

suturing an end portion of the graft to the tubular body structure adjacent one of the first and second locations.

15. The method defined in claim 14, wherein the step of attaching axially spaced portions of the graft to the tubular body structure further comprises:

providing a suturing apparatus through the surgical access opening.

16. A method for installing a tubular graft between first and second spaced locations in a patient'"'"'s tubular body structure comprising:

providing a first aperture through a wall of the tubular body structure at the first location with a distal portion of an elongated structure inserted into and along a lumen of the tubular body structure to the first location;

advancing an elongated guide member along and through the interior of the elongated structure such that a distal portion of the elongated guide member is positioned adjacent the first location;

providing a surgical access opening in the patient adjacent one of the first and second locations;

using the surgical access opening to move the distal portion of the elongated guide member from adjacent the first location into the tubular body structure at the second location by piercing the tubular body structure at the second location;

passing the graft along the lumen of the tubular body structure and over and around an outside of the elongated guide member, through the wall at one of the first and second locations to the other of the locations; and

attaching axially spaced portions of the graft to the tubular body structure adjacent the first and second locations.

17. The method defined in claim 16, wherein the step of moving the distal portion of the elongated guide member comprises:

accessing the elongated guide member with instrumentation inserted into the surgical access opening.

18. The method defined in claim 17, wherein the distal portion of the elongated guide member has a sharpened end portion, and the step of moving the distal portion of the elongated guide member into the tubular body structure comprises:

piercing the tubular body structure at the second location with the sharpened end portion of the elongated guide member.

19. The method defined in claim 16, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises forming anastomotic connections between the graft and the tubular body structure so that the patient'"'"'s body fluid can flow between the lumen of the tubular body structure and the interior of the graft.

20. The method defined in claim 19, wherein a distal portion of the elongated structure has a sharpened portion, and the step of providing the first aperture through the tubular body structure at the first location with the distal portion of the elongated structure comprises:

piercing the tubular body structure at the first location with the sharpened portion of the elongated structure.

21. The method defined in claim 19, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises forming an anastomotic connection between an end of the graft and the first aperture in the wall of the tubular body structure.

22. The method defined in claim 20, wherein a distal portion of the elongated structure has a substantially hollow configuration, and the step of providing the first aperture through the tubular body structure at the first location with the distal portion of the elongated structure comprises:

extending the distal portion of the elongated structure out of the first aperture of the tubular body structure such that a fluid-tight seal is provided between the distal portion of the elongated structure and the first aperture.

23. The method defined in claim 20, wherein the step of advancing the elongated guide member comprises:

extending the distal portion of the elongated guide member from the distal portion of the elongated structure.

24. The method defined in claim 16 wherein the graft has first and second end portions and the method further comprises:

before the step of passing the graft along the lumen of the tubular body structure, attaching a connector to one of the end portions of the graft.

25. The method defined in claim 24 wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

attaching one of the end portions of the graft to the tubular body structure with the connector.

26. The method defined in claim 25 wherein the step of attaching one of the end portions of the graft to the tubular body structure with the connector comprises:

retracting the distal portion of the elongated structure into the lumen of the tubular body structure;

inserting a portion of the connector into the first aperture; and

expanding a portion of the connector in the first aperture.

27. The method defined in claim 24 wherein the step of attaching one of the end portions of the graft to the tubular body structure with the connector comprises:

providing a graft installing structure associated with an end portion of the graft and having a cutting structure and a dilating structure;

making a second aperture with the cutting structure; and

enlarging the second aperture with the dilating structure.

28. The method defined in claim 27 wherein the step of attaching one of the end portions of the graft to the tubular body structure with the connector comprises:

inserting a portion of the connector into the second aperture; and

expanding a portion of the connector in the second aperture.

29. The method defined in claim 16 further comprising:

before the step of moving the distal portion of the elongated guide member, passing a radiopaque marker into and along the lumen of the tubular body structure to the second location to provide a visual aid to the step of moving the distal portion of the elongated guide member to the second location.

30. The method defined in claim 16, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

suturing an end portion of the graft to the tubular body structure adjacent one of the first and second locations.

31. The method defined in claim 30, wherein the step of attaching axially spaced portions of the graft to the tubular body structure further comprises:

providing suturing apparatus through the surgical access opening.

32. A method for installing a tubular graft between first and second spaced locations in a patient'"'"'s tubular body structure comprising:

providing a first aperture through a wall of the tubular body structure at the first location with a distal portion of an elongated structure inserted into and along a lumen of the tubular body structure to the first location;

providing a surgical access opening in the patient adjacent one of the first and second locations;

inserting the graft through the surgical access opening and exterior to the tubular body structure;

using the surgical access opening to move a first end portion of the graft to the first location;

using the surgical access opening to move a second end portion of the graft to the second location; and

attaching axially spaced portions of the graft to the tubular body structure adjacent the first and second locations.

33. The method defined in claim 32, wherein the step of moving the first end portion of the graft to the first location comprises:

accessing the graft with instrumentation inserted into the surgical access opening.

34. The method defined in claim 32, wherein the step of moving the second end portion of the graft to the second location comprises:

accessing the graft with instrumentation inserted into the surgical access opening.

35. The method defined in claim 32, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises forming anastomotic connections between the graft and the tubular body structure so that the patient'"'"'s body fluid can flow between the lumen of the tubular body structure and an interior of the graft.

36. The method defined in claim 35, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises forming an anastomotic connection between an end of the graft and the first aperture in the wall of the tubular body structure.

37. The method defined in claim 32, further comprising:

after providing the first aperture through the wall of the tubular body structure, extending a distal portion of an elongated guide member out of the first aperture.

38. The method defined in claim 37, wherein the step of inserting the graft into the surgical access opening comprises:

passing the graft over the distal portion of the elongated guide member extended out of the first aperture.

39. The method defined in claim 38, wherein the step of moving the first end portion of the graft to the first location comprises:

advancing the graft over the elongated guide member, such that the distal portion of the elongated guide member extends beyond the second end portion of the graft.

40. The method defined in claim 39, wherein the elongated guide member has a sharpened distal portion, the method further comprising:

after the step of advancing the graft over the elongated guide member, using the sharpened distal portion of the elongated guide member to pierce the wall of the tubular body structure to provide a second aperture at the second location and advance the elongated guide member into the lumen of the tubular body structure.

41. The method defined in claim 40, wherein the tubular body structure has a primary fluid flow direction, the method further comprising:

after the step of using the sharpened distal portion of the elongated guide member to pierce the tubular body structure, orienting the distal portion of the elongated guide member positioned in the lumen of the tubular body structure in a downstream orientation substantially aligned with the primary fluid flow direction.

42. The method defined in claim 41 wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

providing a graft installing structure associated with an end portion of the graft configured to pass over the elongated guide member and having a dilating structure; and

enlarging the second aperture with the dilating structure by advancing the dilating structure over the elongated guide member through the wall of the tubular body structure at the second location.

43. The method defined in claim 42 further comprising:

before the step of attaching axially spaced portions of the graft to the tubular body structure, attaching a connector to an end portion of the graft.

44. The method defined in claim 43 wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

inserting a portion of the connector into the second aperture; and

expanding a portion of the connector in the second aperture.

45. The method defined in claim 44 wherein the step of expanding a portion of the connector in the second aperture comprises expanding the connector with the graft installing structure.

46. The method defined in claim 32, wherein the step of attaching axially spaced portions of the graft to the tubular body structure comprises:

suturing an end portion of the graft to the tubular body structure adjacent one of the first and second locations.

47. The method defined in claim 46, wherein the step of attaching axially spaced portions of the graft to the tubular body structure further comprises:

providing a suturing apparatus through the surgical access opening.

48. A method of providing a tubular connection between a patient'"'"'s first tubular body conduit and a second tubular body conduit via an aperture in a side wall of the second tubular body conduit, comprising the steps of:

providing a surgical access opening in the patient;

providing an annular cut in the first conduit, thereby forming a free end portion thereof;

inserting an elongated structure into and axially along the first conduit such that a distal portion extends to the free end portion of the first conduit;

providing the aperture in the side wall of the second tubular body conduit;

advancing the distal portion of the elongated structure to the second tubular body conduit adjacent the aperture in the side wall thereof;

attaching a connector to the free end portion of the first conduit;

shifting the free end portion of the first conduit and the connector to a new location in the patient'"'"'s body adjacent the aperture in the second conduit with instrumentation inserted in the surgical access opening; and

attaching the free end portion of the first conduit to the aperture of the second conduit with the connector.

49. The method defined in claim 48, wherein the connector defines a constant axial length and a cross-section radially expandable between a first diameter sized for insertion into the aperture in the side wall of the second conduit and a second diameter, the method further comprising:

after the step of attaching the connector to the free end portion of the first conduit, inserting the connector while in the first diameter into the aperture in the side wall of the second conduit; and

expanding the connector from the first diameter to the second diameter while maintaining the constant axial length, thereby securing the free end portion of the first conduit coaxially between the connector and the second conduit.

50. The method defined in claim 49, further comprising:

prior to inserting the connector into the aperture in the side wall of the second conduit, extending an elongated guide structure from adjacent the connector and the free end portion of the first conduit, and inserting the elongated guide structure into the aperture in the side wall of the second conduit; and

passing the connector over the elongated guide structure.

51. The method defined in claim 48, wherein the step of inserting the elongated structure into and axially along the first conduit such that the distal portion extends to the free end portion of the first conduit comprises:

providing an aperture in the first conduit remote from the free end portion; and

inserting the elongated structure into the aperture and along a lumen of the first conduit to the free end portion.

52. The method defined in claim 51, further comprising:

before the step of inserting the elongated structure into and axially along the first conduit, inserting the elongated structure into the surgical access opening.