Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
Inventors
Girard, Michael J. • Schlun, Martin
Assignees
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Publication Number
US-12318281-B2
Publication Date
2025-06-03
Expiration Date
Abstract
The present invention relates to a radially collapsible frame (1) for a prosthetic valve, the frame (1) comprising an outflow end region (3) at a proximal end of the frame (1) and an inflow end region (2) at a distal end of the frame (1), opposite to the outflow end region (3). The frame (1) further includes at least two radially spaced commissure attachment regions 910, 10′, 10″) and a cell structure (30), composed of a plurality of lattice cells being arranged radially around a flow axis of the frame (1) and connecting the at least two commissure attachment regions (10, 10′, 10″). Finally, at least one anchoring/positioning arch (20, 20′, 20″) is provided, wherein said at least one anchoring/positioning arch (20, 20′, 20″) radially overlaps the cell structure (30) at least partially. In order to form the inventive frame from as a single piece, the invention further relates to a method comprising bending the at least one anchoring/positioning arch (20, 20′, 20″) towards the cell structure (30) of the frame (1).
Core Innovation
A radially collapsible, shape-memory prosthetic heart-valve frame is described with an outflow-side cell structure lattice connected to commissure attachment regions. The cell-structure lattice comprises lattice cells that extend in the outflow-side region to form a leaflet guard that separates native leaflets from the prosthesis.
Radially overlapping anchoring and positioning arches are connected to the commissure attachment regions. The arches are arranged to radially overlap at least portions of the cell structure, and thereby clamp native commissures and/or commissure pockets and improve anchoring while providing wear resistance at contact regions.
Optional circumferential retaining arches and fastening features are described, including suture fastening holes, notches, and other attachment structures connected to the frame. An optional annular collar is described in flared, tapered, or pear-shaped configurations to transmit radial forces and reduce paravalvular leakage, and the frame includes features such as scalloped inflow edge and shape-memory functionality with expanded second shape and collapsed first shape.
A manufacturing approach is described using laser-cut stent patterns from a hollow shape-memory tube, followed by a shape-setting process in which anchoring and positioning arches are bent toward the cell structure so that the arches radially overlap the cell structure. Alternatives include forming arches separately and connecting them to the frame using welding, suturing, gluing, or riveting, with shaping guided by a shape-memory material programmed by a heat treatment process.
Claims Coverage
Not explicitly described in patent.
Not explicitly described in patent.
Stated Advantages
Provides anchoring by clamping native commissures and/or commissure pockets.
Provides wear resistance at contact regions between the arches and tissue.
Separates native leaflets from the prosthesis via a leaflet guard formed by the cell structure.
Transmits radial forces using an optional annular collar.
Reduces paravalvular leakage with the optional annular collar.
Documented Applications
Prosthetic heart valve systems using a radially collapsible, shape-memory frame for endoprosthesis/valvular prosthesis configurations.
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