Heart valve prosthesis and methods of manufacture and use
First Claim
1. A valve prosthesis comprising:
- a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, and a cell pattern that defines contours, wherein the cell pattern includes a plurality of cells having sizes that vary along the length of the prosthesis, the cell pattern defined by struts; and
a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt at joints, wherein the valve body has a center of coaptation, wherein adjoining leaflets form commissures, wherein the commissures are affixed to the multi-level frame at a location distal of the center of coaptation, and wherein the commissures include flaps that span an entire area of at least one cell of the cell pattern;
wherein the joints include curved portions between a curved base of each leaflet and a scalloped upper edge of the skirt, wherein the curved portions curve longitudinally towards and away from a proximal end of the multi-level frame, wherein the curved portions are aligned with and directly affixed to a curved contour of the multi-level frame defined by the struts of the cells of the multi-level frame so that most of the length of the joints is directly supported by the frame to evenly distribute forces through the valve body to the multi-level frame.
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Accused Products
Abstract
A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.
619 Citations
25 Claims
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1. A valve prosthesis comprising:
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a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, and a cell pattern that defines contours, wherein the cell pattern includes a plurality of cells having sizes that vary along the length of the prosthesis, the cell pattern defined by struts; and a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt at joints, wherein the valve body has a center of coaptation, wherein adjoining leaflets form commissures, wherein the commissures are affixed to the multi-level frame at a location distal of the center of coaptation, and wherein the commissures include flaps that span an entire area of at least one cell of the cell pattern; wherein the joints include curved portions between a curved base of each leaflet and a scalloped upper edge of the skirt, wherein the curved portions curve longitudinally towards and away from a proximal end of the multi-level frame, wherein the curved portions are aligned with and directly affixed to a curved contour of the multi-level frame defined by the struts of the cells of the multi-level frame so that most of the length of the joints is directly supported by the frame to evenly distribute forces through the valve body to the multi-level frame. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A valve prosthesis comprising:
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a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, and a cell pattern that defines contours, wherein the cell pattern includes a plurality of cells having sizes that vary along the length of the prosthesis, the cell pattern defined by struts; and a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt at joints; wherein the joints include curved portions between a curved base of each leaflet and a scalloped upper edge of the skirt, wherein the curved portions curve longitudinally towards and away from a proximal end of the multi-level frame, wherein the curved portions are aligned with and directly affixed to a curved contour of the multi-level frame defined by the struts of the cells of the multi-level frame so that most of the length of the joints is directly supported by the frame to evenly distribute forces through the valve body to the multi-level frame, and wherein the skirt further comprises a plurality of longitudinally-oriented reinforcing tabs or pleats. - View Dependent Claims (23, 24)
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25. A valve prosthesis comprising:
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a self-expanding multi-level frame having a contracted delivery configuration and an expanded deployed configuration, and a cell pattern that defines contours, wherein the cell pattern includes a plurality of cells having sizes that vary along the length of the prosthesis, the cell pattern defined by struts; and a valve body affixed to the multi-level frame, the valve body comprising a plurality of leaflets affixed to a skirt at joints; wherein the joints include curved portions between a curved base of each leaflet and a scalloped upper edge of the skirt, wherein the curved portions curve longitudinally towards and away from a proximal end of the multi-level frame, wherein the curved portions are aligned with and directly affixed to a curved contour of the multi-level frame defined by the struts of the cells of the multi-level frame so that most of the length of the joints is directly supported by the frame to evenly distribute forces through the valve body to the multi-level frame, wherein the skirt comprises a synthetic material, the skirt has a tubular shape in an undeformed configuration, the skirt is configured in a conical frustum shape formed by deforming the synthetic material, and wherein the conical frustum shape is formed by creating a plurality of longitudinally-oriented pleats in the synthetic material.
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Specification