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

• US 20080262602A1
• Filed: 05/09/2008
• Published: 10/23/2008
• Est. Priority Date: 09/10/1998
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Wilk, Peter J., Wolf, Scott J., Phelps, David Y.
• Granted Patent: US 7,736,327 B2
• Time in Patent Office: Days
• US Class Current: 623/1.25
• 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

1-34. -34. (canceled)

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

an expandable, vascularly deliverable, hollow tube having an interior and an exterior and configured to be positioned between and extending into at least one of a blood vessel and a heart chamber; and

a section of human vein positioned within said interior of the tube and adapted to allow blood to flow therethrough, wherein the section of human vein contains at least one naturally occurring valve operable to restrict flow through the conduit from the blood vessel to the heart chamber during diastole.

36. An elongate valve stent comprising:

a stent member, said stent member comprising a support structure and a tissue valve, wherein said tissue valve is configured to permit fluid flow in one direction and prevent fluid flow in an opposite direction, the stent configured to be positioned between and extending into at least one of a blood vessel and a heart chamber; and

means for anchoring said stent member onto surrounding tissue of a blood vessel.

37. The elongate valve stent of claim 36, wherein the blood vessel is a vein.

38. The elongate valve stent of claim 36, wherein the support structure is collapsibly expandable from a first collapsed position to a second expanded position.

39. The elongate valve stent of claim 36, wherein said support structure of the elongate valve stent is self-expandable.

40. The elongate valve stent of claim 36, wherein said support structure of the elongate valve stent is expandable by an inflatable balloon.

41. The elongate valve stent of claim 36, wherein the support structure of said stent is made of a shape-memory material having a first shape transition temperature and a second shape transition temperature, said support structure being collapsibly deformed to below the second shape transition temperature during a stent delivery phase and expanded after delivery in place upon reaching the first shape transition temperature.

42. The elongate valve stent of claim 36, wherein said tissue valve has at least one valve leaflet.

43. The elongate valve stent of claim 42, wherein said 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.

44. The elongate valve stent of claim 42, wherein said tissue valve is one of a venous valve, a pulmonic valve, and an aortic valve.

45. The elongate valve stent of claim 42, wherein said leaflet is chemically treated by a chemical treating agent,

wherein the chemical treating agent is glutaraldehyde.

46. The elongate valve stent of claim 36, wherein said tissue valve is a venous valve procured from a group consisting of a human, a nonhuman animal species, a fetal pig, and a piglet.

47. The elongate valve stent of claim 36, wherein said support structure is made of a material selected from a group consisting of stainless steel, Nitinol, and plastics.

48. The elongate valve stent of claim 36, wherein said support structure is coated with a therapeutic agent.

49. The elongate valve stent of claim 48, wherein said therapeutic agent is selected from a group consisting of growth factors, angiogenesis agents, genes, pharmaceutical compounds, and drugs.

50. The elongate valve stent of claim 36, wherein said anchoring means comprises at least a hook configured for anchoring said stent member onto surrounding tissue.

51. A heart implant comprising:

an expandable, vascularly deliverable, hollow conduit having an interior and an exterior and configured to be positioned between a blood vessel and a heart chamber such that at least a portion of the conduit extends into the blood vessel or the heart chamber; and

a valve of human vein positioned within said interior of the conduit and adapted to allow blood to flow therethrough, wherein the valve of human vein is operable to restrict flow through the conduit from the blood vessel to the heart chamber during diastole.

52. The implant of claim 51, wherein the conduit includes an open, distalmost end and an open, proximalmost end.

53. The implant of claim 52, wherein each of the distalmost and the proximalmost ends is expandable.

54. The implant of claim 51, wherein the conduit includes a longitudinal axis, an open distal end intersecting the longitudinal axis, and an open proximal end intersecting the longitudinal axis.

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

providing a conduit with a first end and a second end;

providing a section of human vein containing at least one naturally occurring valve within the conduit;

placing the conduit within a heart such that the first end of the conduit is open towards the heart chamber, the second end is open towards the blood vessel, and at least a portion of the conduit extends into the heart chamber or 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.

56. A method of flowing blood directly from a left ventricle to an arterial blood-containing vessel, the method comprising:

providing a conduit with a first end and a second end;

providing a valve of animal tissue within the conduit;

enlarging an opening to the left ventricle;

placing the conduit within the opening such that the first end of the conduit is open towards the left ventricle, the second end is open towards the vessel, wherein the first end extends into the left ventricle or the second end extends into the vessel; and

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

57. The method of claim 56, wherein the valve of animal tissue is not a venous valve.

58. The method of claim 56, wherein the valve of animal tissue is an aortic valve.

59. The method of claim 56, wherein the valve of animal tissue is a naturally occurring valve.

60. The method of claim 56, wherein the valve of animal tissue is formed from tissue engineering techniques.

61. The method of claim 56, wherein the conduit is sized so that a first end of the conduit is positionable in the left ventricle and a second end of the conduit is positionable in the arterial blood-containing vessel.

62. The method of claim 56, wherein the conduit is a nitinol stent, and the valve of animal tissue is positioned within the stent so that the stent extends beyond each end of the valve.

63. The method of claim 56, wherein the conduit is a nitinol stent.

64. The method of claim 56, wherein the animal tissue is obtained from a nonhuman animal.

65. The method of claim 56, wherein the placing step occurs after the enlarging step.

66. The method of claim 56, wherein the opening is enlarged by allowing the conduit to expand.

67. The method of claim 56, wherein the first end of the conduit is positioned in the left ventricle.

68. The method of claim 56, further including inhibiting migration of the conduit via at least one of a hook, a barb, and a collar of the conduit.

69. The method of claim 56, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit.

70. The method of claim 69, wherein each of the distalmost and the proximalmost ends is expandable.

71. The method of claim 56, wherein the conduit includes a longitudinal axis and the first and second ends intersect the longitudinal axis.

72. A method of flowing blood directly from a left ventricle to an arterial blood-containing vessel, the method comprising:

providing a conduit with a first end and a second end;

providing a valve of animal tissue within the conduit;

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

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

73. The method of claim 72, wherein the valve of animal tissue is not a venous valve.

74. The method of claim 72, wherein the valve of animal tissue is an aortic valve.

75. The method of claim 72, wherein the valve of animal tissue is not a naturally occurring valve.

76. The method of claim 72, wherein the valve of animal tissue is formed from tissue engineering techniques.

77. The method of claim 72, wherein the first end of the conduit is positioned in the left ventricle.

78. The conduit of claim 72, wherein the conduit is a nitinol stent, and the valve of animal tissue is positioned within the stent so that the stent extends beyond each end of the valve.

79. The method of claim 72, wherein the conduit is a nitinol stent.

80. The method of claim 72, wherein the animal tissue is obtained from a nonhuman animal.

81. The method of claim 72, further comprising inhibiting migration of the conduit via at least one of a hook, a barb, and a collar of the conduit.

82. The method of claim 72, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit.

83. The method of claim 80, wherein each of the distalmost and the proximalmost ends is expandable.

84. The method of claim 72, wherein the conduit includes a longitudinal axis and the first and second ends intersect the longitudinal axis.

85. A method of flowing blood from a left ventricle to an arterial blood-containing vessel, the method comprising:

providing a conduit with a first end and a second end;

providing a valve of animal tissue within the conduit;

placing the conduit onto a catheter so that the conduit is in a compressed state;

introducing the catheter into the aorta;

allowing the conduit to expand and increase the opening of a passageway, such that the first end of the conduit is open towards the left ventricle, and the second end is open towards the vessel;

permitting oxygenated blood to flow directly from the left ventricle to the vessel during systolic contraction of the left ventricle; and

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

86. The method of claim 85, wherein the valve of animal tissue is not a venous valve.

87. The method of claim 85, wherein the valve of animal tissue is an aortic valve.

88. The method of claim 85, wherein the valve of animal tissue is not a naturally occurring valve.

89. The method of claim 85, wherein the valve of animal tissue is formed from tissue engineering techniques.

90. The method of claim 85, wherein the conduit is sized so that the first end of the conduit is positionable in the left ventricle and the second end of the conduit is positionable in the arterial blood-containing vessel.

91. The method of claim 85, wherein the conduit is a nitinol stent, and the valve of animal tissue is positioned within the stent so that the stent extends beyond each end of the valve.

92. The method of claim 85, wherein the conduit is a nitinol stent.

93. The method of claim 85, wherein the animal tissue is obtained from a nonhuman animal.

94. The method of claim 85, further including inhibiting migration of the conduit via at least one of a hook, a barb, and a collar of the conduit.

95. The method of claim 85, wherein the first end is a distalmost end of the conduit and the second end is a proximalmost end of the conduit.

96. The method of claim 95, wherein each of the distalmost and the proximalmost ends is expandable.

97. The method of claim 85, wherein the conduit includes a longitudinal axis and the first and second ends intersect the longitudinal axis.