Method for bilateral intra-aortic bypass

• US 5,316,023 A
• Filed: 01/08/1992
• Issued: 05/31/1994
• Est. Priority Date: 01/08/1992
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Expandable Grafts Partnership
• Inventors: Palmaz, Julio C., LaBorde, Jean C.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/818,052
• Time in Patent Office: 874 Days
• Field of Search: 606/108, 606/153, 606/155, 606/156, 606/191, 606/198, 623/1, 623/12, 128/898
• US Class Current: 128/898
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0034 D-shaped

Abstract

A bilateral intra-aortic bypass graft and method and apparatus for repairing an abdominal aortic aneurysm includes two tubular grafts which are intraluminally delivered to the aorta and secured to the aorta by the expansion and deformation of two expandable and deformable tubular members.

Claims

1. A method for repairing an abdominal aortic aneurysm in an aorta having two iliac arteries associated therewith, comprising the steps of:

(a) providing a first tube connected to a first expandable and deformable, tubular member;

(b) providing a second tube connected to a second expandable and deformable, tubular member, the second tube being separate from the first tube;

(c) providing the first tube and first tubular member disposed upon a first catheter, providing the second tube and second tubular member disposed upon a second catheter, each catheter having an expandable inflatable portion with the tubular members disposed upon the expandable, inflatable portions;

(d) intraluminally delivering the first and second tubes, tubular members, and catheters to the aorta and disposing at least a portion of each tube within the abdominal aortic aneurysm; and

(e) expanding and expandable, inflatable portion of each catheter to expand and deform the tubular members to force the tubular members radially outwardly into contact with the aorta and each other, to secure the tubular members and at least a portion of each tube within the aorta, whereby the tubes provide a bilateral fluid passageway through the abdominal aortic aneurysm.

2. The method of claim 1, including the step of providing a biologically inert coating on the tubes.

3. The method of claim 1, including the step of simultaneously expanding the expandable, inflatable portions of each catheter.

4. The method of claim 1, including the step of utilizing tubes made of a material which is impervious to the flow of fluid.

5. The method of claim 1, including the step of utilizing a tube made of a material which is bio-erodible.

6. The method of claim 1 wherein the tube is made by the replamineform process.

7. The method of claim 1, wherein the first tube, tubular member, and catheter are intraluminally delivered through a first femoral artery;

and the second tube, tubular member, and catheter are intraluminally delivered through a second femoral artery.

8. The method of claim 1, wherein the first and second tubes each have first and second ends, the first end of each tube being connected to a tubular member and disposed within the aorta;

and the second end of the first tube is disposed within one of the iliac arteries and the second end of the second tube is disposed within the other iliac artery.

9. The method of claim 8, wherein a third expandable and deformable, tubular member is connected to the second end of the first tube;

a fourth expandable and deformable, tubular member is connected to the second end of the second tube; and

the third and fourth tubular members are expanded and deformed to force the third and fourth tubular members radially outwardly into contact with an iliac artery by the expansion of the expandable, inflatable portion of each catheter associated with each tube.

10. The method of claim 1, including the step of forming each tube of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, by aligning the plurality of tubular members with their longitudinal axes being substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular members;

and embedding the plurality of tubular members within a layer of a deformable and expandable plastic material.

11. The method of claim 10, wherein the plastic material is silicone.

12. The method of claim 10, wherein the plastic material is polytetrafluoroethylene.

13. The method of claim 12, wherein the plastic material is expanded polytetrafluoroethylene.

14. The method of claim 10, wherein the plastic material is expanded polyurethane.

15. The method of claim 10, including the step of simultaneously expanding the expandable, inflatable portion of each catheter to simultaneously expand and deform the first and second tubular members and the plurality of tubular members of each tube which are embedded in the deformable and expandable plastic material.

16. The method of claim 10, including the step of connecting the first and second tubular members to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected.

17. The method of claim 1, further including the steps of:

(a) providing a fifth expandable and deformable, tubular member disposed upon a fifth catheter having an expandable, inflatable portion, with the fifth tubular member disposed upon the expandable, inflatable portion;

(b) intraluminally delivering the fifth tubular member and third catheter to the aorta;

(c) expanding the expandable, inflatable portion of the third catheter to expand and deform the fifth tubular member to force the fifth tubular member radially outwardly into contact with the aorta to secure the fifth tubular member within the aorta;

the foregoing steps (a)-(c) being conducted prior to the intraluminal delivery of the first and second tubes, tubular members, and catheters, whereby upon the expansion of the expandable, inflatable portions of the first and second catheters, the first and second tubular members are expanded and deformed radially outwardly into contact with the fifth tubular member and each other, to secure the first and second tubular members within the aorta and within the fifth tubular member.

18. The method of claim 1, including the steps of providing each tube formed of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, providing the plurality of tubular members with their longitudinal axes being aligned substantially parallel with each other, each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members;

and providing the plurality of tubular members embedded within a layer of a deformable and expandable plastic material.

19. The method of claim 18, wherein the plastic material is silicone.

20. The method of claim 18, wherein the plastic material is polytetrafluoroethylene.

21. The method of claim 20, wherein the plastic material is expanded polytetrafluoroethylene.

22. The method of claim 18, wherein the plastic material is expanded polyurethane.

23. The method of claim 18, including the step of simultaneously expanding the expandable, inflatable portion of each catheter to simultaneously expand and deform the first and second tubular members and the plurality of tubular members of each tube which are embedded in the deformable and expandable plastic material.

24. The method of claim 18, including the step of connecting the first and second tubular members to the first and second tubes by embedding a portion of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected.

25. The method of claim 1, including the step of utilizing tubes made of a synthetic polyester material.

26. The method of claim 1, including the step of utilizing tubes made of polytetrafluoroethylene.

27. A method for repairing an abdominal aortic aneurysm in an aorta having two iliac arteries association therewith, comprising the steps of:

(a) providing a first tube connected to a first expandable and deformable, tubular member;

(b) providing a second tube connected to a second expandable and deformable, tubular member, the second tube being separate from the first tube; and

(c) expanding the expandable and deformable tubular members to expand and deform the tubular members to force the tubular members radially outwardly into contact with the aorta and each other, to secure the tubular members and at least a portion of each tube within the aorta, whereby the tubes provide a bilateral fluid passageway through the abdominal aortic aneurysm.

28. The method of claim 27, including the step of providing a biologically inert coating on the tubes.

29. The method of claim 27, including the step of utilizing tubes made of a synthetic polyester material.

30. The method of claim 27, including the step of utilizing tubes made of polytetrafluoroethylene.

31. The method of claim 27, including the step of simultaneously expanding and deforming the tubular members.

32. The method of claim 27, including the step of utilizing tubes made of a material which is impervious to the flow of fluid.

33. The method of claim 27, including the step of utilizing a tube made of a material which is bioerodible.

34. The method of claim 27, wherein the tube is made by the replamineform process.

35. The method of claim 27, wherein the first tube and tubular member are intraluminally delivered through a first femoral artery;

and the second tube and tubular member are intraluminally delivered through a second femoral artery.

36. The method of claim 27, wherein the first and second tubes each have first and second ends, the first end of each tube being connected to a tubular member and disposed within the aorta;

and the second end of the first tube is disposed within one of the iliac arteries and the second end of the second tube is disposed within the other iliac artery.

37. The method of claim 36 including the steps of:

providing a third expandable and deformable, tubular member connected to the second end of the first tube;

providing a fourth expandable and deformable, tubular member connected to the second end of the second tube; and

the third and fourth tubular members are expanded and deformed to force the third and fourth tubular members radially outwardly into contact with an iliac artery.

38. The method of claim 27, including the steps of providing each tube formed of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, the plurality of tubular members with their longitudinal axes being aligned substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular members;

and providing the plurality of tubular members embedded within a layer of a deformable and expandable plastic material.

39. The method of claim 38, wherein the plastic material is silicone.

40. The method of claim 38, wherein the plastic material is polytetrafluoroethylene.

41. The method of claim 40, wherein the plastic material is expanded polytetrafluoroethylene.

42. The method of claim 38, wherein the plastic material is expanded polyurethane.

43. The method of claim 38, including the step of simultaneously expanding and deforming the first and second tubular members and the plurality of tubular members of each tube which are embedded in the deformable and expandable plastic material.

44. The method of claim 38, including the step of providing the first and second tubular members connected to the first and second tubes by providing a portion of the second ends of the first and second tubular members embedded in the deformable and expandable plastic material of the tube to which it is to be connected.

45. The method of claim 27, further including the step of:

(a) expanding and deforming a fifth tubular member to force the fifth tubular member radially outwardly into contact with the aorta to secure the fifth tubular member within the aorta;

the foregoing step (a) being conducted prior to the expansion and deformation of the first and second tubular members, whereby upon the expansion and deformation of the first and second tubular members, the first and second tubular members are expanded and deformed radially outwardly into contact with the fifth tubular member and each other, to secure the first and second tubular members within the aorta and within the fifth tubular member.

46. The method of claim 27, including the steps of providing each tube formed of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, providing the plurality of tubular members with their longitudinal axes being aligned substantially parallel with each other, each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members;

and providing the plurality of tubular members embedded within a layer of a deformable and expandable plastic material.

47. The method of claim 46, wherein the plastic material is silicone.

48. The method of claim 46, wherein the plastic material is polytetrafluoroethylene.

49. The method of claim 48, wherein the plastic material is expanded polytetrafluoroethylene.

50. The method of claim 46, wherein the plastic material is expanded polyurethane.

51. The method of claim 46, including the step of simultaneously expanding and deforming the first and second tubular members and the plurality of tubular members of each tube which are embedded in the deformable and expandable plastic material.

52. The method of claim 46, including the step of providing the first and second tubular members connected to the first and second tubes by providing a portion of the first and second tubular members embedded in the deformable and expandable plastic material of the tube to which it is to be connected.

53. A method for repairing a body passageway comprising the steps of:

(a) providing a first tube connected to a first expandable and deformable, tubular member;

(b) providing a second tube connected to a second expandable and deformable, tubular member, the second tube being separate from the first tube; and

(c) expanding the expandable and deformable tubular members to expand and deform the tubular members to force the tubular members radially outwardly into contact with the body passageway and each other, to secure the tubular members and at least a portion of each tube within the body passageway, whereby the tubes provide a bilateral fluid passageway through the body passageway.

54. The method of claim 53, including the step of providing a biologically inert coating on the tubes.

55. The method of claim 53, including the step of utilizing tubes made of a synthetic polyester material.

56. The method of claim 53, including the step of utilizing tubes made of polytetrafluoroethylene.

57. The method of claim 53, including the step of simultaneously expanding and deforming the tubular members.

58. The method of claim 53, including the step of utilizing tubes made of a material which is impervious to the flow of fluid.

59. The method of claim 53, including the step of utilizing a tube made of a material which is bioerodible.

60. The method of claim 53, wherein the tube is made by the replamineform process.

61. The method of claim 53, wherein the first tube and tubular member are intraluminally delivered through a first femoral artery;

and the second tube and tubular member are intraluminally delivered through a second femoral artery.

62. The method of claim 53, wherein the first and second tubes each have first and second ends, the first end of each tube being connected to a tubular member and disposed within the body passageway;

and the second end of the first tube is disposed within the body passageway and the second end of the second tube is disposed within the body passageway.

63. The method of claim 62, including the steps of:

providing a third expandable and deformable, tubular member connected to the second end of the first tube;

providing a fourth expandable and deformable, tubular member connected to the second end of the second tube; and

the third and fourth tubular members are expanded and deformed to force the third and fourth tubular members radially outwardly into contact with the body passageway.

64. The method of claim 53, including the steps of providing each tube formed of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, providing the plurality of tubular members with their longitudinal axes being aligned substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular member;

and providing the plurality of tubular members embedded within a layer of a deformable and expandable plastic material.

65. The method of claim 64, wherein the plastic material is silicone.

66. The method of claim 64, wherein the plastic material is polytetrafluoroethylene.

67. The method of claim 66, wherein the plastic material is expanded polytetrafluoroethylene.

68. The method of claim 64, wherein the plastic material is expanded polyurethane.

69. The method of claim 64, including the step of simultaneously expanding and deforming the first and second tubular members and the plurality of tubular members of each tube which are embedded in the deformable and expandable plastic material.

70. The method of claim 64, including the steps of providing the first and second tubular members connected to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected.

71. The method of claim 53, further including the step of:

(a) expanding and deforming a fifth tubular member to force the fifth tubular member radially outwardly into contact with the body passageway to secure the fifth tubular member within the body passageway;

the foregoing step (a) being conducted prior to the expansion and deformation of the first and second tubular members, whereby upon the expansion and deformation of the first and second tubular members, the first and second tubular members are expanded and deformed radially outwardly into contact with the fifth tubular member and each other, to secure the first and second tubular members within the body passageway and within the fifth tubular member.

72. The method of claim 53, including the steps of providing each tube formed of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, providing the plurality of tubular members with their longitudinal axes being aligned substantially parallel with each other, each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members;

and providing the plurality of tubular members embedded within a layer of a deformable and expandable plastic material.

73. The method of claim 72, wherein the plastic material is silicone.

74. The method of claim 72, wherein the plastic material is polytetrafluoroethylene.

75. The method of claim 74, wherein the plastic material is expanded polytetrafluoroethylene.

76. The method of claim 72, wherein the plastic material is expanded polyurethane.

77. The method of claim 72, including the step of simultaneously expanding and deforming the first and second tubular members and the plurality of tubular members of each tube which are embedded in the deformable and expandable plastic material.

78. The method of claim 72, including the step of providing the first and second tubular members connected to the first and second tubes by providing a portion of the first and second tubular members embedded in the deformable and expandable plastic material of the tube to which it is to be connected.