Medical anastomosis apparatus

• US 6,113,612 A
• Filed: 11/06/1998
• Issued: 09/05/2000
• Est. Priority Date: 11/06/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Cardiovascular Group Incorporated
• Inventors: Swanson, William J., Galdonik, Jason A., Berg, Todd Allen, Wahlberg, Mark D., Thome, Scott P.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Trinh, Vikki
• Application Number:
  US09/186,774
• Time in Patent Office: 669 Days
• Field of Search: 606/153, 606/151, 606/152, 606/154, 606/194, 606/192, 606/198, 623/1, 623/12
• US Class Current: 623/1.15
• 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 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A connector for use in providing an anastomotic connection between two tubular body fluid conduits in a patient. The connector is preferably a single, integral, plastically deformable structure that can be cut from a tube. The connector has axial spaced portions that include members that are radially outwardly deflectable from other portions of the connector. The connector is annularly enlargeable so that it can be initially delivered and installed in the patient in a relatively small annular size and then annularly enlarged to provide the completed anastomosis. The radially outwardly deflected members of the first and second portions respectively engage the two body fluid conduits connected at the anastomosis and hold those two conduits together in fluid-tight engagement. Apparatus for use in delivering and deploying a connector is also disclosed.

Claims

1. A connector for use in making an anastomotic connection between tubular body fluid conduits in a patient comprising a unitary structure disposed annularly about a longitudinal axis and having axially spaced first and second portions, said first portion having a plurality of annularly spaced first members that are deflectable radially out from a remainder of said structure, said second portion having a plurality of annularly spaced second members that are deflectable radially out from a remainder of said structure, and said structure being configured for annular enlargement, in use, along its entire length parallel to the longitudinal axis.

2. The connector defined in claim 1 wherein said structure is configured for formation by removal of selected material from a single unitary tubular member.

3. The connector defined in claim 1 wherein said structure is further configured so that said annular enlargement reduces axial spacing between said first and second members.

4. The connector defined in claim 1 wherein the first members have free ends that point toward the second portion.

5. The connector defined in claim 4 wherein the second members have free ends that point toward the first portion.

6. The connector defined in claim 4 wherein the free ends of the first members are configured to penetrate a side wall of a first of the tubular body fluid conduits at locations that are annularly spaced around the anastomotic connection.

7. The connector defined in claim 6 wherein the second members have free ends that are configured to penetrate a side wall of a second of the tubular body fluid conduits at locations that are annularly spaced around the anastomotic connection.

8. The connector defined in claim 1 wherein the first members have free ends that are deflectable so that they point toward the second portion.

9. The connector defined in claim 8 wherein the second members have free ends that are deflectable so that they point toward the first portion.

10. The connector defined in claim 1 wherein said structure is configured for annular enlargement in response to inflation of a balloon disposed inside said structure.

11. The connector defined in claim 1 wherein said structure is configured for disposition substantially concentric with the anastomotic connection.

12. The connector defined in claim 11 wherein the first portion is configured for disposition substantially concentrically relative to an axial end portion of a first of the tubular body fluid conduits.

13. The connector defined in claim 12 wherein the second portion is configured for disposition through an aperture in a side wall of a second of the tubular body fluid conduits so that the anastomotic connection is an end-to-side connection between the first and second tubular body fluid conduits.

14. The connector defined in claim 11 wherein the first portion is configured for disposition through an aperture in a side wall of a first of the tubular body fluid conduits and the second portion is configured for disposition through an aperture in a side wall of a second of the tubular body fluid conduits so that the anastomotic connection is a side-to-side connection between the first and second tubular body fluid conduits.

15. The connector defined in claim 1 wherein the first members are plastically deflectable radially out from a remainder of said structure.

16. The connector defined in claim 15 wherein the second members are plastically deflectable radially out from a remainder of said structure.

17. The connector defined in claim 1 wherein said structure is configured for plastic annular enlargement.

18. The connector defined in claim 1 wherein said structure has axially spaced first and second segments configured to annularly enlarge in response to respective different first and second amounts of applied annular enlargement force.

19. The connector defined in claim 1 wherein said first members are configured for deflection radially out from a remainder of said structure in response to inflation of a balloon disposed inside said structure.

20. The connector defined in claim 1 wherein said first members have free end portions that are configured to facilitate penetration of a side wall of at least one of said tubular body fluid conduits.

21. The connector defined in claim 20 wherein the free end portions of said first members are sharply pointed to facilitate penetration of the side wall of said at least one tubular body fluid conduit.

22. The connector defined in claim 20 wherein said free end portions of the first members are configured to resist withdrawal from the side wall of said at least one tubular body fluid conduit after penetration of said side wall.

23. The connector defined in claim 1 wherein each of said first members comprises a U-shaped component, the legs of the U remote from the base of the U being connected to respective parts of a remainder of the structure that are configured to annularly separate from one another when the structure is annularly enlarged.

24. The connector defined in claim 1 wherein said structure comprises a plurality of annularly spaced axially extending component members, each of which is connected to a first associated annularly adjacent component member at first and second axially spaced locations, and each of which is connected to a second associated annularly adjacent component member at a third location which is axially medial said first and second locations.

25. The connector defined in claim 24 wherein said structure is configured for annular enlargement by deforming each of said component members to increase the annular space between that component member and the first associated component member adjacent the third location and to increase the annular space between that component member and the second associated component member adjacent the first and second locations.

26. The connector defined in claim 24 wherein each of the first members is joined to a remainder of said structure adjacent a respective one of the first locations.

27. The connector defined in claim 26 wherein each of the second members is joined to a remainder of said structure adjacent a respective one of the second locations.

28. The connector defined in claim 1 wherein the unitary structure comprises first and second layers, each of which is substantially concentric with said longitudinal axis, said first and second layers being adjacent to one another radially from said longitudinal axis.

29. The connector defined in claim 28 wherein said first layer is made of a material selected for its radiologic properties, and wherein said second layer is made of a material selected for its mechanical properties.

30. The connector defined in claim 2 wherein said tubular member is clad tubing.

31. The connector defined in claim 30 wherein said clad tubing has a first annular layer selected for its radiologic properties and a second layer concentric with the first layer and selected for its mechanical properties.

32. The connector defined in claim 1 further comprising a body of medicine-releasing material disposed on the unitary structure.

33. The connector defined in claim 32 wherein the medicine-releasing material comprises a polymer.

34. The connector defined in claim 33 wherein the body of medicine-releasing material comprises a band disposed annularly around the unitary structure.

35. The connector defined in claim 32 wherein the first members are configured to penetrate a side wall of a first of the tubular body fluid conduits, and wherein the body of medicine-releasing material includes portions disposed on the first members where the first members are configured to penetrate the side wall of the first tubular body fluid conduit.

36. The connector defined in claim 1 further comprising a band of elastic material disposed annularly around the unitary structure.

37. A connector for use in making an anastomotic connection between tubular body fluid conduits in a patient comprising a unitary structure disposed annularly about a longitudinal axis and having axially spaced first and second portions, said first portion having a plurality of annularly spaced first members that are deflectable radially out from a remainder of said structure, and said structure being configured to be annularly enlarged and to respond to such annular enlargement by decreasing in axial spacing between said first and second portions.

38. The connector defined in claim 37 wherein said structure is configured for formation by removal of selected material from a single unitary tubular member.

39. The connector defined in claim 37 wherein the first members have free ends that point toward the second portion.

40. The connector defined in claim 37 wherein the first members have free ends that are configured to penetrate a side wall of a first of the tubular body fluid conduits.

41. The connector defined in claim 37 wherein the first members have free ends that are configured to penetrate a side wall of a first of the tubular body fluid conduits at locations that are annularly spaced around the anastomotic connection.

42. The connector defined in claim 37 wherein the first members have free ends that are deflectable so that they point toward the second portion.

43. The connector defined in claim 37 wherein said structure is configured to be annularly enlarged by inflation of a balloon disposed inside said structure.

44. The connector defined in claim 37 wherein said structure is configured for disposition substantially concentric with the anastomotic connection.

45. The connector defined in claim 37 wherein the first portion is configured for disposition through an aperture in a side wall of a first of the tubular body fluid conduits.

46. The connector defined in claim 45 wherein the second portion is configured for disposition substantially concentrically relative to an axial end portion of a second of the tubular body fluid conduits so that the anastomotic connection can be an end-to-side connection between the first and second tubular body fluid conduits.

47. The connector defined in claim 45 wherein the second portion is configured for disposition through an aperture in a side wall of a second of the tubular body fluid conduits so that the anastomotic connection can be a side-to-side connection between the first and second tubular body fluid conduits.

48. The connector defined in claim 37 wherein the first members are plastically deflectable radially out from a remainder of said structure.

49. The connector defined in claim 37 wherein said structure is configured for plastic annular enlargement.

50. The connector defined in claim 37 wherein said structure has axially spaced first and second segments configured to annularly enlarge in response to respective different first and second amounts of applied annular enlargement force.

51. The connector defined in claim 37 wherein said first members are configured for deflection radially out from a remainder of said structure in response to inflation of a balloon disposed inside said structure.

52. The connector defined in claim 37 wherein said first members have free end portions that are configured to facilitate penetration of a side wall of at least one of said tubular body fluid conduits.

53. The connector defined in claim 52 wherein the free end portions of said first members are sharply pointed to facilitate penetration of the side wall of said at least one tubular body fluid conduit.

54. The connector defined in claim 52 wherein the free end portions of the first members are configured to resist withdrawal from the side wall of said at least one tubular body fluid conduit after penetration of said side wall.

55. The connector defined in claim 37 wherein each of said first members comprises a U-shaped component, the legs of the U remote from the base of the U being connected to respective parts of a remainder of the structure that are configured to annularly separate from one another when the structure is annularly enlarged.

56. The connector defined in claim 37 wherein said structure comprises a plurality of annularly spaced, axially extending component members, each of which is connected to a first associated annularly adjacent component member at first and second axially spaced locations, and each of which is connected to a second associated annularly adjacent component member at a third location which is axially medial said first and second locations.

57. The connector defined in claim 56 wherein said structure is configured to be annularly enlarged by deforming each of said component members to increase the annular space between that component member and the first associated component member adjacent the third location and to increase the annular space between that component member and the second associated component member adjacent the first and second locations.

58. The connector defined in claim 56 wherein each of the first members is joined to a remainder of said structure adjacent a respective one of the first locations.

59. The connector defined in claim 37 wherein the unitary structure comprises first and second layers, each of which is substantially concentric with said longitudinal axis, said first and second layers being adjacent to one another radially from said longitudinal axis.

60. The connector defined in claim 59 wherein said first layer is made of a material selected for its radiologic properties, and wherein said second layer is made of a material selected for its mechanical properties.

61. The connector defined in claim 38 wherein said tubular member is clad tubing.

62. The connector defined in claim 61 wherein said clad tubing has a first annular layer selected for its radiologic properties and a second layer concentric with the first layer and selected for its mechanical properties.

63. The connector defined in claim 37 further comprising a body of medication-releasing material disposed on the unitary structure.

64. The connector defined in claim 63 wherein the medication-releasing material comprises a polymer.

65. The connector defined in claim 64 wherein the body of medication-releasing material comprises a band disposed annularly around the unitary structure.

66. The connector defined in claim 63 wherein the first members are configured to penetrate a side wall of a first of the tubular body fluid conduits, and wherein the body of medication-releasing material includes potions disposed on the first members where the first members are configured to penetrate the side wall of the first tubular body fluid conduit.

67. The connector defined in claim 37 further comprising a band of elastic material disposed annularly around the unitary structure.