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Publication Number
US-11806233-B2
Publication Date
2023-11-07
Expiration Date
Abstract
The present invention provides a prosthetic heart valve device that has a frame, and a leaflet assembly having a plurality of leaflets that are secured to the frame. The frame is defined by an annular body and has three spaced-apart commissure regions, each commissure region having a commissure post extending from a proximal outflow end of the frame. A first clipping arm and a second clipping arm extend from opposite sides of each commissure post, each clipping arm extending from each commissure post at an obtuse angle with respect to each commissure post. Each clipping arm has a free end with a tip provided at the free end. The body has a first diameter at a location where the tips of the clipping arms are located, and the tips of the clipping arms extend away from define a second diameter, with the second diameter being greater than or equal to the first diameter.
Core Innovation
The invention relates to a prosthetic heart valve device for deployment in an aortic annulus that includes a plurality of native leaflets. The device comprises a frame defined by an annular body defined by an arrangement of cells, having a distal inflow end and a proximal outflow end, and three spaced-apart connector portions or three spaced-apart commissure regions, each providing a location for commissure posts. A leaflet assembly having a plurality of leaflets is secured to the frame.
Each connector portion or commissure post supports a first clipping arm and a second clipping arm that extend from opposite sides of the connector portion or commissure post, with each clipping arm having a free end and a tip at the free end. The body has a first diameter at a circumferential line location, and the tips of some clipping arms extend away from the body at the circumferential line location to define a circumferential line with a second diameter greater than the first diameter or greater than or equal to the first diameter. The clipping arms are configured so the first clipping arm is positioned behind a native leaflet and the second clipping arm is positioned in front of the native leaflet, thereby sandwiching the native leaflet between the clipping arms.
In further embodiments, the clipping arms extend from their commissure post at an obtuse angle or at an angle ranging from 90 to 180 degrees with respect to the commissure post. The tips are positioned along a circumferential line of the frame closer to the distal inflow end than to the proximal outflow end, and the circumferential line relationship can be defined by the tip-defined first and second diameters. The disclosed construction includes a cell-based annular frame with three commissure regions and commissure posts.
Claims Coverage
The provided material includes three independent claims, centered on a specific annular, cell-based frame with three connector portions or commissure regions and paired first and second clipping arms configured to position relative to native leaflets, an associated securing method using a delivery system to deploy the clipping arms behind and in front of native leaflets, and further device geometry specifying obtuse-angle extension and circumferential-line placement of clipping-arm tips relative to the distal inflow end and proximal outflow end. Across these independent claims, the main inventive features are the circumferential line diameter relationship created by clipping-arm tips, the paired behind/in-front leaflet positioning, and the commissure/post-based architecture of the clipping arms.
Circumferential-line tip diameter greater than body diameter with behind/in-front leaflet positioning
A prosthetic heart valve device for deployment in an aortic annulus including a plurality of native leaflets, comprising a cell-defined annular frame with three spaced-apart connector portions; a first clipping arm and a second clipping arm extending from opposite sides of each connector portion with free ends and tips; wherein the body has a first diameter at a circumferential line location, and the tips of some clipping arms extend away from the body at the circumferential line location to define a circumferential line with a second diameter greater than the first diameter; a leaflet assembly secured to the frame; and wherein the first clipping arm is configured to be positioned behind a native leaflet and the second clipping arm is configured to be positioned in front of the native leaflet.
Crimping and deployment securing by positioning clipping arms behind and in front of native leaflets
A method of securing a prosthetic heart valve device at an aortic annulus of a patient including a plurality of native leaflets, comprising providing a prosthetic heart valve device having a frame defined by an annular body defined by an arrangement of cells with three spaced-apart commissure regions each having a commissure post; a first clipping arm and a second clipping arm extending from opposite sides of each commissure post, each clipping arm extending from its respective commissure post at an angle ranging from 90 to 180 degrees with respect to the respective commissure post and having a free end with a tip; wherein the body has a first diameter and the tips of some clipping arms extend away from the body to define a second diameter that is greater than or equal to the first diameter; a leaflet assembly secured to the frame; crimping the heart valve device inside a delivery system; delivering the heart valve device to the annulus; and deploying the heart valve device at the annulus by positioning the first clipping arm behind a native leaflet and positioning the second clipping arm in front of the native leaflet.
Obtuse-angle clipping arms with tips on a circumferential line closer to the distal inflow end than the proximal outflow end
A prosthetic heart valve device for deployment in an aortic annulus including a plurality of native leaflets, comprising a cell-defined annular frame having a distal inflow end and a proximal outflow end; three spaced-apart commissure regions each having a commissure post extending from the proximal outflow end; a first clipping arm and a second clipping arm extending from opposite sides of each commissure post, each clipping arm extending at an obtuse angle with respect to the respective commissure post and having a free end with a tip; wherein the tips of the clipping arms are positioned along a circumferential line of the frame closer to the distal inflow end than to the proximal outflow end; a leaflet assembly having a plurality of leaflets secured to the frame; wherein the first clipping arm is configured to be positioned behind a native leaflet and the second clipping arm is configured to be positioned in front of the native leaflet.
Across the independent claims, the claim coverage focuses on a prosthetic valve frame with three connector portions or commissure regions and commissure posts, carrying paired clipping arms with free tips that define a circumferential-line diameter relationship relative to the body and are configured for positioning behind and in front of native leaflets. The independent claims further distinguish geometric relationships for the clipping arms, including extension at obtuse angles or 90 to 180 degree ranges and placement of the tip-defined circumferential line closer to the distal inflow end than to the proximal outflow end, and they include a method of securing or deploying the valve by crimping, delivering, and deploying with the behind/in-front clipping-arm positioning.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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