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

• US 8,597,226 B2
• Filed: 06/12/2012
• Issued: 12/03/2013
• Est. Priority Date: 09/10/1998
• Status: Expired due to Term

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Wilk, Peter J., Phelps, David Y., Wolf, Scott J.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US13/494,589
• Publication Number:
  US 20130144203A1
• Time in Patent Office: 539 Days
• Field of Search: 604 401- 616, 604 8- 10, 604/96.01, 604 27- 30, 604/500, 604506-509, 604/511, 604263-266, 604/523, 604530-532, 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, 623/2.13, 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 method of treatment, comprising:

placing a conduit adjacent a left ventricle and an arterial blood-containing vessel such that upon placement of the conduit a first end of the conduit is continuously open towards and facing the left ventricle, a second end of the conduit is continuously open towards, facing, and positioned in the arterial blood-containing vessel, and at least a portion of the first open end faces at least a portion of the second open end;

wherein the conduit includes a substantially tubular structure at each of the first and second ends, and wherein a valve is attached to the conduit within an interior of the conduit between the first and second ends to control a backflow of blood from the arterial blood-containing vessel to the left ventricle during diastole.

2. The method of claim 1, further including enlarging an opening between the left ventricle and the arterial blood-containing vessel and thereafter placing the conduit within the opening.

3. The method of claim 1, further including placing the conduit onto a catheter so that the conduit is in a compressed state, and introducing the catheter into an aorta.

4. The method of claim 3, further including introducing the catheter into a femoral artery before introducing the catheter into an aorta.

5. The method of claim 1, further including placing the conduit onto a catheter so that the conduit is in a compressed state, and introducing the catheter into a vein.

6. The method of claim 1, wherein the valve is an aortic valve.

7. The method of claim 1, wherein the valve is formed from tissue engineering techniques.

8. The method of claim 1, wherein the first end is a distalmost end of the conduit, and the second end is a proximalmost end of the conduit, and each of the distalmost and the proximalmost ends is expandable.

9. The method of claim 1, wherein upon placement of the conduit, the first end of the conduit is positioned in the left ventricle.

10. The method of claim 1, wherein the conduit is a metal conduit.

11. The method of claim 1, wherein the conduit is a plastic conduit.

12. The method of claim 1, wherein a section of tissue is further attached within the interior of the conduit adjacent the first end.

13. The method of claim 1, wherein the conduit has a substantially tubular structure between the first and second ends.

14. The method of claim 13, wherein the conduit has a substantially uniform tubular structure between the first and second ends.

15. A method of treatment, comprising:

placing a conduit adjacent a left ventricle and an arterial blood-containing vessel such that upon placement of the conduit a first end of the conduit is continuously open towards and facing the left ventricle, a second end of the conduit is continuously open towards, facing, and positioned in the arterial blood-containing vessel, and a substantially straight line intersects at least a portion of the first end and at least a portion of the second end;

wherein the conduit includes a substantially tubular structure adjacent each of the first and second ends, and wherein a valve is attached to the conduit within an interior of the conduit between the first and second ends to control a backflow of blood from the arterial blood-containing vessel toward the left ventricle during diastole.

16. The method of claim 15, further including placing the conduit onto a catheter so that the conduit is in a compressed state, and introducing the catheter into an aorta.

17. The method of claim 16, further including introducing the catheter into a femoral artery before introducing the catheter into an aorta.

18. The method of claim 15, further including placing the conduit onto a catheter so that the conduit is in a compressed state, and introducing the catheter into a vein.

19. The method of claim 15 further including enlarging an opening between the left ventricle and the arterial blood-containing vessel and thereafter placing the conduit within the opening.

20. The method of claim 15, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit, and each of the distalmost and the proximalmost ends is expandable.

21. The method of claim 20, wherein upon placement of the conduit, the first end of the conduit is positioned in the left ventricle.

22. The method of claim 20, wherein the valve is an aortic valve.

23. The method of claim 20, wherein the valve is formed from tissue engineering techniques.

24. The method of claim 20, wherein the conduit is a metal conduit.

25. The method of claim 20, wherein the conduit is a plastic conduit.

26. The method of claim 20, wherein a section of tissue is further attached within the interior of the conduit adjacent the first end.

27. The method of claim 15, wherein the conduit includes a longitudinal axis that is substantially straight between the first and second ends.

28. The method of claim 15, wherein the conduit has a substantially tubular structure between the first and second ends.

29. The method of claim 28, wherein the conduit has a substantially uniform tubular structure between the first and second ends.

30. A method of treatment, comprising:

introducing a catheter into an aorta, wherein a metal, expandable conduit having a tissue valve attached to the conduit is coupled to the catheter so that the conduit and the valve are each in a compressed state; and

implanting the conduit adjacent a left ventricle and an arterial blood-containing vessel such that upon implantation a distalmost end of the conduit is continuously open towards and facing the left ventricle, a proximalmost end of the conduit is continuously open towards, facing, and positioned in the arterial blood-containing vessel, and at least a portion of the distalmost open end faces at least a portion of the proximalmost open end;

wherein the conduit includes a substantially tubular structure adjacent each of the distalmost and proximalmost ends and between the distalmost and proximalmost ends, and the valve is attached to the conduit within an interior of the conduit between the distalmost and proximalmost ends to control a backflow of blood from the arterial blood-containing vessel toward the left ventricle during diastole.

31. The method of claim 30, further including expanding the distalmost end and the proximalmost end.

32. The method of claim 30, further including enlarging an opening between the left ventricle and the arterial blood-containing vessel and thereafter placing the conduit within the opening.

33. The method of claim 30, further including introducing the catheter into a femoral artery before introducing the catheter into an aorta.

34. The method of claim 30, wherein upon implantation of the conduit the distalmost end of the conduit is positioned in the left ventricle.

35. The method of claim 30, wherein the conduit includes a substantially straight longitudinal axis and the distalmost and proximalmost ends intersect the longitudinal axis.

36. The method of claim 30, wherein the valve is an aortic valve.

37. The method of claim 30, wherein a section of tissue is further attached within the interior of the conduit adjacent the distalmost end.

38. The method of claim 30, wherein the conduit has a substantially uniform tubular structure between the first and second ends.

39. An implantable prosthesis, comprising:

a self-expandable, metal conduit having an interior and an exterior, the conduit configured to be, upon implantation, positioned between an arterial blood containing vessel and a left ventricle such that a first end of the conduit is continuously open towards and facing the left ventricle, a second end of the conduit is continuously open towards, facing, and positioned in the arterial blood containing vessel, and at least a portion of the first end faces at least a portion of the second end, wherein the conduit has a substantially tubular structure at each of the first and second ends; and

a tissue valve attached to the conduit within the interior of the conduit between the first and second ends, the valve being configured to permit fluid flow from the left ventricle to the blood vessel and restrict fluid flow from the blood vessel to the left ventricle.

40. The prosthesis of claim 39, wherein the blood vessel is an artery.

41. The prosthesis of claim 39, wherein the conduit is self-expandable from a first collapsed position to a second expanded position.

42. The prosthesis of claim 39, wherein the first end of the conduit is configured to extend into the left ventricle.

43. The prosthesis of claim 39, wherein the first end of the conduit is configured to extend into the left ventricle, and the second end of the conduit is configured to extend into the arterial blood containing vessel.

44. The prosthesis of claim 39, wherein the conduit is hollow and comprises (i) an integral one-piece conduit or (ii) plural sections joined together to form a continuous conduit.

45. The prosthesis of claim 39, wherein the conduit has a substantially tubular structure between the first and second ends.

46. The prosthesis of claim 39, wherein the conduit is made of Nitinol.

47. The prosthesis of claim 39, wherein the tissue valve has at least one valve leaflet.

48. The prosthesis of claim 47, wherein the leaflet is from a valve which naturally occurs in a group consisting of a human, a nonhuman animal species, a fetal pig, and a piglet.

49. The prosthesis of claim 39, wherein the tissue valve is one of a pulmonic valve or an aortic valve.

50. The prosthesis of claim 39, wherein the valve is operable to permit fluid flow through the conduit from the left ventricle to the blood vessel during systole.

51. The prosthesis of claim 39, wherein the valve is operable to restrict fluid flow through the conduit from the blood vessel to the left ventricle during diastole.

52. The prosthesis of claim 39, further including means for anchoring the conduit to restrict migration of the prosthesis relative to surrounding tissue.

53. The prosthesis of claim 39, further including a hook or a barb attached to the conduit and configured for anchoring the conduit onto surrounding tissue.

54. The prosthesis of claim 39, wherein the tissue valve is attached to the interior of the conduit by suturing.

55. The prosthesis of claim 39, wherein the tissue valve is a naturally occurring valve.

56. The prosthesis of claim 39, wherein the first end is a distalmost end of the conduit, the second end is a proximalmost end of the conduit, and each of the distalmost and the proximalmost ends is expandable.

57. The prosthesis of claim 39, wherein the conduit includes a longitudinal axis that is substantially straight between the first and second ends.

58. The prosthesis of claim 39, further including a section of tissue further attached within the interior of the conduit adjacent the first end.

59. The prosthesis of claim 39, wherein a substantially straight line intersects at least a portion of the first end and at least a portion of the second end.

60. The method of claim 39, wherein the conduit has a substantially tubular structure between the first and second ends.

61. The method of claim 60, wherein the conduit has a substantially uniform tubular structure between the first and second ends.

62. An implantable prosthesis, comprising:

a self-expandable hollow metal conduit having an interior and an exterior, the conduit configured to be, upon implantation, positioned between an arterial blood containing vessel and a left ventricle such that a first end of the conduit is continuously open and facing the left ventricle, a second end of the conduit is continuously open, facing, and positioned in the arterial blood containing vessel, wherein the conduit has a substantially straight longitudinal axis between the first and second ends, and wherein the conduit has a substantially tubular structure at each of the first and second ends; and

a tissue valve attached to the conduit within the interior of the conduit between the first and second ends, the valve being configured to permit fluid flow from the left ventricle to the blood vessel and restrict fluid flow from the blood vessel to the left ventricle.

63. The prosthesis of claim 62, wherein the first end is a distalmost end of the conduit, the second end is a proximalmost end of the conduit, and each of the distalmost and the proximalmost ends is expandable.

64. The prosthesis of claim 62, wherein the first end of the conduit is configured to extend into the left ventricle.

65. The method of claim 62, wherein the conduit has a substantially uniform tubular structure between the first and second ends.

66. The method of claim 65, wherein the conduit has a substantially uniform tubular structure between the first and second ends.

67. An implantable prosthesis, comprising:

a self-expandable hollow metal conduit having an interior and an exterior, the conduit configured to be positioned between an arterial blood containing vessel and a left ventricle such that a first end of the conduit is continuously open and facing the left ventricle, a second end of the conduit is continuously open, facing, and positioned in the arterial blood containing vessel, wherein a substantially straight line intersects at least a portion of the first end of the conduit and at least a portion of the second end of the conduit, and wherein the conduit has a substantially tubular structure at each of the first and second ends; and

a tissue valve attached to the conduit within the interior of the conduit between the first and second ends, the valve being configured to permit fluid flow from the left ventricle to the blood vessel and restrict fluid flow from the blood vessel to the left ventricle.

68. The prosthesis of claim 67, wherein the first end is a distalmost end of the conduit, the second end is a proximalmost end of the conduit, and each of the distalmost and the proximalmost ends is expandable.

69. The prosthesis of claim 67, wherein the first end of the conduit is configured to extend into the left ventricle.

70. The method of claim 67, wherein the conduit has a substantially tubular structure between the first and second ends.

71. The method of claim 70, wherein the conduit has a substantially uniform tubular structure between the first and second ends.