Replacement heart valve prosthesis
Inventors
Peterson, Matthew A. • Yi, Seung-Beom • Vad, Siddharth • Oba, Travis Zenyo • Freschauf, Lauren R. • French, Amanda • Keidar, Yaron • Du, Yuanlong • Bak-Boychuk, Gregory • Golemo, Kevin M. • Cooper, Alexander H.
Assignees
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Publication Number
US-12447011-B2
Publication Date
2025-10-21
Expiration Date
Abstract
A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.
Core Innovation
The invention relates to a heart valve prosthesis for replacing a native heart valve. The prosthesis includes a self-expanding frame with an upper region, an intermediate region, and a lower region, and the self-expanding frame comprises an inner frame and a supplemental outer frame attached together at the upper region. Anchoring members extend outward from the lower region and upward toward the upper region to facilitate capturing of the native heart valve by at least some of the anchoring members.
A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction. Each leaflet has an arcuate proximal edge and a free distal edge, and the leaflets are joined at commissures. Connecting fabric or one or more intermediate components connect the leaflets to the self-expanding frame so that, when the frame is in an expanded configuration, the commissures are spaced radially inwardly from an inner surface of the self-expanding frame.
The invention further includes a skirt that surrounds and is spaced apart from the outer surface of the self-expanding frame so as to form a clearance and impede blood flow around the self-expanding frame. In some constructions, the skirt includes wires formed from a resilient material to allow the skirt to retain a particular shape. The disclosed constructions also encompass skirt fixation options and frame/anchor architectures for mitral replacement and valve-in-valve/backstop configurations.
Claims Coverage
The independent claims define a self-expanding heart valve prosthesis for replacing a native heart valve. Across the claims, the inventive features focus on the multi-region frame architecture with inner frame and supplemental outer frame, anchoring members for capturing the native valve, leaflet-to-frame coupling that spaces commissures radially inward when expanded, and skirt structures spaced from the outer surface to impede blood flow around the frame.
Multi-region self-expanding frame with inner frame and supplemental outer frame
A heart valve prosthesis comprising a self-expanding frame having an upper region, an intermediate region and a lower region, the self-expanding frame comprising an inner frame and a supplemental outer frame, and the inner frame and the supplemental outer frame are attached together at the upper region of the self-expanding frame.
Anchoring members extending outward and upward for capturing
A self-expanding frame including a plurality of anchoring members extending outward from the lower region of the self-expanding frame and then upward toward the upper region of the self-expanding frame so as to facilitate capturing of the native heart valve by at least some of the plurality of anchoring members.
Leaflet commissures radially inward via connecting fabric
A valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets joined at commissures, and a connecting fabric that connects the plurality of leaflets to the self-expanding frame such that, when the self-expanding frame is in an expanded configuration, the commissures are spaced radially inwardly from an inner surface of the self-expanding frame.
Leaflet commissures radially inward via intermediate components
A valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets joined at commissures, and one or more intermediate components that connect the plurality of leaflets to the self-expanding frame such that, when the frame is in an expanded configuration, the commissures are spaced radially inwardly from an inner surface of the self-expanding frame.
Skirt surrounding and spaced to impede blood flow around the frame
A heart valve prosthesis further comprising a skirt surrounding and spaced apart from an outer surface of the self-expanding frame so as to form a clearance between the outer surface of the self-expanding frame and the skirt, the skirt configured to impede blood flow around the self-expanding frame.
Skirt with resilient wires retaining shape
A skirt surrounding an outer surface of at least the lower region of the self-expanding frame, the skirt configured to impede blood flow around the self-expanding frame, wherein the skirt further comprises wires formed from a resilient material for allowing the skirt to retain a particular shape.
The claims center on a self-expanding multi-region frame with anchoring members, a leaflet valve body with commissures spaced radially inward by connecting fabric or intermediate components, and a spaced skirt configured to impede blood flow around the frame, with resilient wires in the skirt in additional embodiments.
Stated Advantages
Facilitates capturing of the native heart valve by at least some of the plurality of anchoring members.
Allows commissures to be spaced radially inwardly from an inner surface of the self-expanding frame when the frame is in an expanded configuration.
Impedes blood flow around the self-expanding frame.
Allows the skirt to retain a particular shape.
Improved hemodynamic performance, including improved underside washout and reduced thrombosis risk.
Reduction of perivalvular/backflow by forming an axial barrier using the skirt structure.
Documented Applications
Mitral replacement.
Valve-in-valve/backstop configurations.
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