Methods and conduits for flowing blood from a heart chamber to a blood vessel

• US 7,704,222 B2
• Filed: 08/30/2004
• Issued: 04/27/2010
• Est. Priority Date: 09/10/1998
• Status: Expired due to Term

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Wolf, Scott J., Phelps, David Y., Wilk, Peter J.
• Primary Examiner(s): Deak; Leslie R.
• Assistant Examiner(s): Wiest; Philip R
• Application Number:
  US10/928,190
• Publication Number:
  US 20050033220A1
• Time in Patent Office: 2,066 Days
• Field of Search: 604 401- 616, 604/8, 604/9, 604/96.01, 604/8.1, 604 27- 30, 604/500, 604506-509, 604/511, 604263-266, 604/523, 604530-532, 623/2.13, 623/1.1, 623 111- 112, 623/1.15, 623/1.17, 623/1.18, 623/1.2, 623 121- 125, 623/1.31, 623/1.32, 623 136- 139, 623 2364- 2371, 128/898, 606/153
• US Class Current: 604/9
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Disclosed is a conduit that provides a bypass around an occlusion or stenosis in a coronary artery. The conduit is a tube adapted to be positioned in the heart wall to provide a passage for blood to flow between a heart chamber and a coronary artery, at a site distal to the occlusion or stenosis. The conduit has a section of blood vessel attached to its interior lumen which preferably includes at least one naturally occurring one-way valve positioned therein. The valve prevents the backflow of blood from the coronary artery into the heart chamber.

Claims

1. A conduit for implantation in the heart, the conduit comprising:

an expandable, vascularly deliverable, hollow, metal tube having an interior and an exterior and configured to be positioned between a blood vessel and a heart chamber;

a first end open towards and positioned within the blood vessel and a second end open towards the heart chamber, wherein the first and second ends are continuously open upon implantation of the conduit in a body, the tube includes a substantially lattice structure adjacent each of the first and second ends and extending therebetween, and a substantially straight line intersects at least a portion of the first end and at least a portion of the second end; and

a section of body tissue attached to the tube within said interior of the tube and adapted to allow blood to flow therethrough, wherein the section of body tissue contains at least one tissue valve operable to restrict flow through the conduit from the blood vessel to the heart chamber during diastole, wherein the valve is positioned between the first and second ends.

2. The conduit of claim 1, wherein the section of body tissue is a section of a blood vessel.

3. The conduit of claim 2, wherein the section of blood vessel is one of an autograft, an allograft, and a xenograft.

4. The conduit of claim 1, wherein said heart chamber is a left ventricle.

5. The conduit of claim 1, wherein the tube is self-expandable.

6. The conduit of claim 1, wherein the conduit includes an attachment mechanism adapted to connect to heart and/or vessel tissue.

7. The conduit of claim 1, wherein the conduit is configured to be delivered in a compressed configuration.

8. The conduit of claim 1, wherein the conduit is configured to be delivered via a catheter.

9. The conduit of claim 1, wherein the blood vessel is a coronary vessel.

10. The conduit of claim 9, wherein the coronary vessel is a coronary artery.

11. The conduit of claim 1, wherein the first end is a distalmost end and the second end is a proximalmost end.

12. The conduit of claim 11, wherein each of the distalmost and the proximalmost ends is expandable.

13. The conduit of claim 1, wherein the tube and the section of body tissue are substantially the same length.

14. A method of flowing blood from a heart chamber to a blood vessel, the method comprising:

inserting within a body a metal conduit with a first end and a second end, wherein each of the first and second ends is continuously open upon implantation of the conduit in the body, and at least a portion of the first end faces at least a portion of the second end;

wherein a section of tissue is attached to the conduit within the interior of the conduit adjacent the first end, the section of tissue including a tissue valve attached to the conduit within an interior of the conduit, and positioned between the first and second ends;

placing the conduit within a heart wall such that the first end of the conduit is open towards the heart chamber, the second end is open towards the blood vessel, and the second end is positioned within the blood vessel; and

during diastole, restricting a flow of blood from the blood vessel to the heart chamber via the tissue valve.

15. The method of claim 14, wherein the section of tissue includes a section of blood vessel containing at least one naturally occurring valve.

16. The method of claim 15, wherein the section of blood vessel is one of an autograft, an allograft, and a xenograft.

17. The method of claim 14, wherein the heart chamber is a left ventricle.

18. The method of claim 14, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit.

19. The method of claim 18, wherein each of the distalmost and the proximalmost ends is expandable.

20. The method of claim 14, wherein the conduit includes a longitudinal axis and the first and second ends intersect the longitudinal axis.

21. The method of claim 14, wherein placing the conduit includes deploying the conduit via a solid delivery rod.

22. A heart implant comprising:

an expandable, vascularly deliverable, hollow, metal conduit having an interior and an exterior and configured to be positioned between a blood vessel and a heart chamber;

a first end open towards and positioned within the blood vessel and a second end open towards the heart chamber, wherein each of the first and second ends is continuously open upon implantation of the conduit in a body, at least a portion of the first open end faces at least a portion of the second open end, and the conduit includes a substantially lattice structure adjacent each of the first and second ends and extending therebetween; and

a valve of animal tissue attached to the conduit within said interior of the conduit and positioned between the first and second ends and adapted to allow blood to flow therethrough, wherein the valve of animal tissue is operable to restrict flow through the conduit from the blood vessel to the heart chamber during diastole.

23. The implant of claim 22, wherein the animal tissue is obtained from a nonhuman animal.

24. The implant of claim 23, wherein the nonhuman animal is a pig.

25. The implant of claim 22, wherein the valve of animal tissue is a section of a blood vessel.

26. The implant of claim 25, wherein the section of the blood vessel is one of an autograft, an allograft, and a xenograft.

27. The implant of claim 22, wherein said heart chamber is a left ventricle.

28. The implant of claim 22, wherein the conduit is self-expandable.

29. The implant of claim 22, wherein the implant includes an attachment mechanism adapted to connect to heart and/or vessel tissue.

30. The implant of claim 29, wherein the attachment mechanism includes one of a barb, a hook, and a collar.

31. The implant of claim 22, wherein the conduit is configured to be delivered in a compressed configuration.

32. The implant of claim 22, wherein the conduit is configured to be delivered via a catheter.

33. The implant of claim 22, wherein the blood vessel is a coronary vessel.

34. The implant of claim 22, wherein the conduit is a stent.

35. The heart implant of claim 22, wherein the first end is a distalmost end and the second end is a proximalmost end.

36. The heart implant of claim 35, wherein each of the distalmost and the proximalmost ends is expandable.

37. The heart implant of claim 22, wherein the conduit includes a longitudinal axis, the first end intersects the longitudinal axis, and the second end intersects the longitudinal axis.

38. The implant of claim 22, wherein the valve of animal tissue is formed from tissue engineering techniques.

39. A method of flowing blood from a heart chamber to a blood vessel, the method comprising:

inserting into a body a metal conduit with a first end and a second end, wherein each of the first and second ends is continuously open upon implantation of the conduit in the body, a substantially straight line intersects at least a portion of the first end and at least a portion of the second end, and the conduit includes a substantially lattice structure adjacent each of the first and second ends and extending therebetween;

wherein a valve of animal tissue is attached to the conduit within an interior of the conduit and positioned between the first and second ends;

placing the conduit within a heart such that the first end of the conduit is open towards the heart chamber, and the second end is open towards the blood vessel and positioned within the blood vessel; and

during diastole, restricting a flow of blood from the blood vessel to the heart chamber via the valve of animal tissue.

40. The method of claim 39, wherein the animal tissue is obtained from a nonhuman animal.

41. The method of claim 40, wherein the nonhuman animal is a pig.

42. The method of claim 39, wherein the valve includes a section of blood vessel containing at least one naturally occurring valve.

43. The method of claim 42, wherein the section of blood vessel is one of an autograft, an allograft, and a xenograft.

44. The method of claim 39, wherein the heart chamber is a left ventricle.

45. The method of claim 39, wherein the blood vessel is a coronary vessel.

46. The method of claim 39, further comprising delivering the conduit to the heart by a catheter threaded through an artery into the aorta.

47. The method of claim 39, wherein placing the conduit includes expanding the conduit.

48. The method of claim 39, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit.

49. The method of claim 48, wherein each of the distalmost and the proximalmost ends is expandable.

50. The method of claim 39, wherein the conduit includes a longitudinal axis and the first and second ends intersect the longitudinal axis.

51. The method of claim 39, wherein placing the conduit includes deploying the conduit via a solid delivery rod.

52. The method of claim 39, wherein the animal tissue is obtained from tissue engineering techniques.

53. A conduit for implantation in the heart, the conduit comprising:

an expandable, vascularly deliverable, hollow, metal tube having an interior and an exterior and configured to be positioned between a blood vessel and a heart chamber;

a first end open towards and positioned within the blood vessel and a second end open towards the heart chamber, wherein the first and second ends are continuously open upon implantation of the conduit in a body, and wherein a substantially straight line intersects at least a portion of the first end and at least a portion of the second end; and

a section of body tissue attached to the conduit adjacent the second end and within said interior of the tube and adapted to allow blood to flow therethrough, wherein the section of body tissue contains a valve of animal tissue operable to restrict flow through the conduit from the blood vessel to the heart chamber during diastole, wherein the valve is positioned between the first and second ends.

54. The conduit of claim 53, wherein the section of body tissue is a section of a blood vessel.

55. The conduit of claim 54, wherein the section of blood vessel is one of an autograft, an allograft, and a xenograft.

56. The conduit of claim 53, wherein the conduit is self-expandable.

57. The conduit of claim 53, wherein the conduit includes an attachment mechanism adapted to connect to heart and/or vessel tissue.

58. The conduit of claim 53, wherein the conduit is configured to be delivered in a compressed configuration.

59. The conduit of claim 53, wherein the conduit is configured to be delivered via a catheter.

60. The conduit of claim 53, wherein the tube includes at least one of a hook, a barb, and a collar to inhibit migration of the conduit.

61. The conduit of claim 53, wherein the valve is operable to permit flow through the conduit from the heart chamber to the blood vessel during systole.

62. The conduit of claim 53, wherein the valve of animal tissue is an aortic valve.

63. The conduit of claim 53, wherein the valve is chemically treated by a chemical treating agent.

64. The conduit of claim 63, wherein the chemical treating agent is glutaraldehyde.

65. The conduit of claim 53, wherein the tube is a nitinol stent.

66. The conduit of claim 53, wherein the body tissue is obtained from a nonhuman animal.

67. A method of flowing blood from a heart chamber to a blood vessel, the method comprising:

inserting into a body a conduit with a first end and a second end, wherein each of the first and second ends is continuously open upon implantation of the conduit in the body, and a substantially straight line intersects at least a portion of the first end and at least a portion of the second end, the conduit further including a substantially lattice structure adjacent the first end and adjacent the second end and extending therebetween;

wherein a valve of animal tissue is attached to the conduit within an interior of the conduit and positioned between the first and second ends;

placing the conduit between the heart chamber and the blood vessel such that the first end of the conduit is open towards the heart chamber, the second end is open towards the blood vessel, and the second end is positioned within the blood vessel; and

during diastole, restricting a flow of blood from the blood vessel to the heart chamber via the valve of animal tissue.

68. The method of claim 67, wherein the animal tissue is obtained from a nonhuman animal.

69. The method of claim 68, wherein the nonhuman animal is a pig.

70. The method of claim 67, wherein the valve includes a section of blood vessel containing at least one naturally occurring valve.

71. The method of claim 70, wherein the section of blood vessel is one of an autograft, an allograft, and a xenograft.

72. The method of claim 67, wherein the heart chamber is a left ventricle.

73. The method of claim 67, wherein the blood vessel is a coronary vessel.

74. The method of claim 67, further comprising delivering the conduit to the heart by a catheter threaded through an artery into the aorta.

75. The method of claim 67, wherein placing the conduit includes expanding the conduit.

76. The method of claim 67, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit.

77. The method of claim 76, wherein each of the distalmost and the proximalmost ends is expandable.

78. The method of claim 67, wherein the conduit includes a longitudinal axis and the first and second ends intersect the longitudinal axis.

79. The method of claim 67, wherein the conduit includes at least one of a hook, a barb, and a collar to inhibit migration of the conduit.

80. The method of claim 67, wherein the valve of animal tissue includes an aortic valve.

81. The method of claim 67, wherein the valve of animal tissue includes a non-venous valve.

82. The method of claim 67, wherein the valve of animal tissue is formed from tissue engineering techniques.

83. The method of claim 67, wherein placing the conduit includes delivery the conduit via a solid delivery rod.