VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS

• US 20080009940A1
• Filed: 03/28/2007
• Published: 01/10/2008
• Est. Priority Date: 12/31/1996
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Cribier, Alain
• Granted Patent: US 8,591,575 B2
• Time in Patent Office: Days
• US Class Current: 623/002.11
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

Claims

1-77. -77. (canceled)

78. A method for treating a stenotic native aortic valve in a human heart, comprising:

advancing a guidewire through the femoral artery and around the aortic arch in a direction against the flow of blood;

advancing a dilatation catheter over the guidewire, the dilatation catheter having an inflatable balloon disposed along a distal end portion;

dilating the native aortic valve by inflating the balloon within the native aortic valve to push aside the valvular leaflets of the native aortic valve;

withdrawing the dilatation catheter over the guidewire;

advancing a delivery catheter over the guidewire, the delivery catheter having a prosthetic heart valve disposed along a distal end portion, the prosthetic heart valve including a collapsible and expandable metallic stent and a collapsible and expandable valvular structure sutured to the stent, the valvular structure being formed of pericardial tissue and adapted for replacing the function of the native aortic valve;

radially expanding the prosthetic heart valve within the dilated native aortic valve such that the prosthetic heart valve engages the valvular leaflets of the dilated native aortic valve;

withdrawing the delivery catheter over the guidewire; and

removing the guidewire.

79. The method of claim 78, wherein a balloon is inflated to assist with the radial expansion of the prosthetic heart valve.

80. The method of claim 78, wherein an internal cover is attached to an inner surface of the stent for preventing passage of blood through open spaces in the stent.

81. The method of claim 80, wherein the stent is collapsed to a diameter of about 4 to 5 millimeters during advancement of the delivery catheter over the guidewire.

82. A method for treating a stenotic native aortic valve in a human heart, comprising:

percutaneously accessing the native aortic valve through the femoral artery and around the aortic arch in a direction against the flow of blood;

dilating the native aortic valve by inflating a balloon to push aside the valvular leaflets of the native aortic valve; and

radially expanding a prosthetic heart valve within the dilated native aortic valve such that the prosthetic heart valve engages the valvular leaflets of the dilated native aortic valve, the prosthetic heart valve comprising a collapsible and expandable stent and a collapsible and expandable valvular structure fastened to the stent, the valvular structure configured to prevent blood from flowing from the aorta back into the left ventricle.

83. The method of claim 82, wherein the valvular structure is configured to fold inward on itself when the stent is in a radially collapsed condition.

84. The method of claim 82, wherein the valvular structure is formed of biological tissue.

85. The method of claim 84, wherein the biological tissue is pericardial tissue.

86. The method of claim 85, wherein an internal cover is attached to the stent for preventing passage of blood through open spaces in the stent.

87. The method of claim 86, wherein the internal cover is located only on the inlet side of the valvular structure.

88. The method of claim 86, wherein the internal cover is made from pericardial tissue.

89. The method of claim 88, wherein the valvular structure and internal cover are sewn to the stent.

90. The method of claim 82, wherein the native aortic valve is dilated to a diameter of at least about 20 millimeters before radially expanding the prosthetic heart valve.

91. The method of claim 82, wherein the prosthetic heart valve is radially expanded such that the valvular structure is located adjacent to the aortic annulus.

92. The method of claim 82, wherein the valvular structure is treated with a substance having anti-thrombotic properties.

93. The method of claim 82, wherein the stent is formed of a metallic material selected such that the stent is viewable under fluoroscopy during radial expansion of the prosthetic heart valve.

94. The method of claim 82, wherein the stent has a substantially cylindrical shape.

95. The method of claim 82, wherein the stent has a maximum diameter of about 23 millimeters in the radially expanded condition.

96. The method of claim 82, wherein the stent has a diameter in the range of about 4 to 5 millimeters in the radially collapsed condition.

97. The method of claim 82, wherein a balloon is inflated to cause the radial expansion of the prosthetic heart valve.

98. The method of claim 82, wherein at least a portion of the stent has a concave profile for reinforcing embedding of the prosthetic heart valve within the native aortic valve.

99. The method of claim 98, wherein the stent comprises a metallic frame having a grate shape.

100. A method for treating a stenotic native aortic valve in a human heart, comprising:

advancing a guidewire through the femoral artery and around the aortic arch in a direction against the flow of blood;

advancing a dilatation catheter over the guidewire, the dilatation catheter having an inflatable balloon disposed along a distal end portion;

dilating the native aortic valve by inflating the balloon within the native aortic valve to push aside the valvular leaflets of the native aortic valve;

advancing a delivery catheter over the guidewire, the delivery catheter having a prosthetic heart valve disposed along a distal end portion, the prosthetic heart valve including a collapsible and expandable stent and a collapsible and expandable valvular structure, the stent having a concave profile and having a grate shape construction formed of metallic bars, the valvular structure being formed of pericardial tissue and sewn to the stent for replacing the function of the native aortic valve; and

radially expanding the prosthetic heart valve within the dilated native aortic valve such that the prosthetic heart valve engages the valvular leaflets of the dilated native aortic valve.