SEQUENTIALLY DEPLOYED TRANSCATHETER MITRAL VALVE PROSTHESIS
First Claim
1. A method of delivering an implantable prosthetic valve to a patient'"'"'s heart, the patient'"'"'s heart having a mitral valve with an anterior leaflet and a posterior leaflet, said method comprising:
- providing a prosthetic valve, wherein the prosthetic valve comprises an expandable frame having a first end, a second end opposite the first end, a first anterior tab on an anterior portion of the expandable frame, a posterior tab on a posterior portion of the expandable frame, and a ventricular skirt adjacent the first end of the expandable frame, andwherein the prosthetic valve has an expanded configuration for engaging the heart and a collapsed configuration;
delivering the prosthetic valve in the collapsed configuration to the patient'"'"'s heart adjacent the mitral valve;
expanding the first anterior tab radially outward such that a tip portion of the first anterior tab engages a first fibrous trigone on a first side of the anterior leaflet of the mitral valve, andwherein the anterior leaflet and adjacent anterior chordae tendineae are disposed between the first anterior tab and an outer anterior surface of the ventricular skirt;
after radially expanding the first anterior tab, radially expanding the posterior tab outward such that the posterior leaflet of the mitral valve and adjacent posterior chordae tendinae are disposed between the posterior tab and an outer posterior surface of the ventricular skirt;
after radially expanding the posterior tab, radially expanding the ventricular skirt outward thereby engaging the anterior and posterior leaflets,wherein the anterior leaflet and the adjacent anterior chordae tendinae are captured between the first anterior tab and the outer anterior surface of the ventricular skirt, andwherein the posterior leaflet and the adjacent posterior chordae tendinae are captured between the posterior tab and the posterior outer surface of the ventricular skirt.
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Accused Products
Abstract
A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.
221 Citations
124 Claims
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1. A method of delivering an implantable prosthetic valve to a patient'"'"'s heart, the patient'"'"'s heart having a mitral valve with an anterior leaflet and a posterior leaflet, said method comprising:
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providing a prosthetic valve, wherein the prosthetic valve comprises an expandable frame having a first end, a second end opposite the first end, a first anterior tab on an anterior portion of the expandable frame, a posterior tab on a posterior portion of the expandable frame, and a ventricular skirt adjacent the first end of the expandable frame, and wherein the prosthetic valve has an expanded configuration for engaging the heart and a collapsed configuration; delivering the prosthetic valve in the collapsed configuration to the patient'"'"'s heart adjacent the mitral valve; expanding the first anterior tab radially outward such that a tip portion of the first anterior tab engages a first fibrous trigone on a first side of the anterior leaflet of the mitral valve, and wherein the anterior leaflet and adjacent anterior chordae tendineae are disposed between the first anterior tab and an outer anterior surface of the ventricular skirt; after radially expanding the first anterior tab, radially expanding the posterior tab outward such that the posterior leaflet of the mitral valve and adjacent posterior chordae tendinae are disposed between the posterior tab and an outer posterior surface of the ventricular skirt; after radially expanding the posterior tab, radially expanding the ventricular skirt outward thereby engaging the anterior and posterior leaflets, wherein the anterior leaflet and the adjacent anterior chordae tendinae are captured between the first anterior tab and the outer anterior surface of the ventricular skirt, and wherein the posterior leaflet and the adjacent posterior chordae tendinae are captured between the posterior tab and the posterior outer surface of the ventricular skirt. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. A method of delivering an implantable prosthetic valve to a patient'"'"'s heart, the patient'"'"'s heart having a mitral valve with an anterior leaflet and a posterior leaflet, said method comprising:
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providing a prosthetic valve, wherein the prosthetic valve comprises an expandable frame having a first end, a second end opposite the first end, a first anterior tab on anterior portion of the expandable frame, a posterior tab on a posterior portion of the expandable frame, and a ventricular skirt adjacent the first end of the expandable frame, and wherein the prosthetic valve has an expanded configuration for engaging the heart and a collapsed configuration; delivering the prosthetic valve in the collapsed configuration to the patient'"'"'s heart adjacent the mitral valve; expanding the first anterior tab radially outward such that a tip portion of the first anterior tab engages a first fibrous trigone on a first side of the anterior leaflet of the mitral valve, and wherein the anterior leaflet and adjacent anterior chordae tendineae are disposed between the first anterior tab and an outer anterior surface of the ventricular skirt; after radially expanding the first anterior tab, radially expanding the ventricular skirt outward thereby engaging the anterior leaflet, wherein the anterior leaflet and the adjacent anterior chordae tendinae are captured between the first anterior tab and the outer anterior surface of the ventricular skirt; after radially expanding the ventricular skirt, radially expanding the posterior tab outward such that the posterior leaflet of the mitral valve and adjacent posterior chordae tendinae are disposed and captured between the posterior tab and an outer posterior surface of the ventricular skirt. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
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61. A sequentially deployed prosthetic cardiac valve, said valve comprising:
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a self-expanding frame having a first end, a second end opposite the first end, an atrial region near the second end, and a ventricular region near the first end, wherein the self-expanding frame has an expanded configuration and a collapsed configuration, the expanded configuration adapted to engage heart tissue, and the collapsed configuration adapted to be delivered to a patient'"'"'s heart; a self-expanding atrial skirt disposed in the atrial region; a self-expanding ventricular skirt disposed in the ventricular region; a self-expanding annular region disposed between the atrial region and the ventricular region; a first self-expanding anterior tab disposed on an anterior portion of the self-expanding frame in the ventricular region; and a self-expanding posterior tab on a posterior portion of the self-expanding frame in the ventricular region, wherein a portion of the first self-expanding anterior tab and a portion of the self-expanding posterior tab partially self-expand radially outward when a constraint is removed therefrom, and wherein the first anterior tab fully self-expands radially outward before the posterior tab fully self-expands radially outward when the constraint is removed therefrom, and wherein the posterior tab fully self-expands radially outward before ventricular skirt self-expands when the constraint is removed therefrom, and wherein the ventricular skirt fully expands last. - View Dependent Claims (62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 112)
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91. A sequentially deployed prosthetic cardiac valve, said valve comprising:
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a self-expanding frame having a first end, a second end opposite the first end, an atrial region near the second end, and a ventricular region near the first end, wherein the self-expanding frame has an expanded configuration and a collapsed configuration, the expanded configuration adapted to engage heart tissue, and the collapsed configuration adapted to be delivered to a patient'"'"'s heart; a self-expanding atrial skirt disposed in the atrial region; a self-expanding ventricular skirt disposed in the ventricular region; a self-expanding annular region disposed between the atrial region and the ventricular region; a first self-expanding anterior tab disposed on an anterior portion of the self-expanding frame in the ventricular region; and a self-expanding posterior tab on a posterior portion of the self-expanding frame in the ventricular region, wherein a portion of the first self-expanding anterior tab and a portion of the self-expanding posterior tab partially self-expand radially outward when a constraint is removed therefrom, and wherein the first anterior tab self-expands radially outward before the ventricular skirt self-expands radially outward when the constraint is removed therefrom, and wherein the ventricular skirt self-expands radially outward before the posterior tab finishes self-expanding, and wherein the posterior tab finishes self-expanding after the ventricular skirt self-expands. - View Dependent Claims (92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 113, 114, 115, 116, 117, 118, 119, 120)
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121. A delivery system for delivering a prosthetic cardiac valve to a patient'"'"'s heart, the heart having a mitral valve with an anterior leaflet and a posterior leaflet, said delivery system comprising:
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a prosthetic cardiac valve; an inner guidewire shaft having a lumen extending therethrough, the lumen sized to slidably receive a guidewire; a distal tissue penetrating tip coupled to a distal portion of the inner guidewire shaft, the distal tip adapted to pass through and expand tissue in the heart, wherein a continuous flared region couples the inner guidewire shaft with the distal tip, the continuous flared region configured to support the prosthetic cardiac valve thereby reducing or eliminating unwanted bending of the prosthetic cardiac valve; a hub shaft concentrically disposed over the inner guidewire shaft, wherein the prosthetic cardiac valve is releasably coupled to a distal portion of the hub shaft; a bell shaft slidably and concentrically disposed over the hub shaft; an outer sheath slidably and concentrically disposed over the bell shaft, wherein the prosthetic cardiac valve is housed in the outer sheath in a radially collapsed configuration; and a handle near a proximal end of the delivery system, the handle comprising an actuator mechanism adapted to advance and retract the bell shaft and the sheath. - View Dependent Claims (122, 123, 124)
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Specification