Systems, devices and methods for folded unibody heart valve stents
Inventors
Noe, Spencer C. • Boyette, Jeremy J. • Gregg, Peter W. • Haynes, Evelyn N. • Wallace, Daniel T.
Assignees
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Publication Number
US-12295838-B2
Publication Date
2025-05-13
Expiration Date
Abstract
A replacement heart valve comprises a unibody, folded, double-wall stent, with a stent cover and a leaflet valve attached to the inner lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent restraint assembly provided by fixed guide openings or structures along the distal end of the delivery system that independently permits expansion of the distal and proximal ends of the outer wall of the stent, and control of the inner wall expansion simultaneously with or separately from the expansion of the outer wall.
Core Innovation
The invention relates to a replacement heart valve that includes a unibody stent frame with a folded double-wall and collapsed and expanded configurations. The stent frame comprises an outer wall having a downstream open enlarged diameter region, a middle reduced diameter region, and an upstream closed enlarged diameter region, together with a tubular inner wall having a central lumen and a transition wall between the upstream closed enlarged diameter region of the outer wall and the inner wall.
The folded double-wall design provides a geometry described in terms of radii of curvature between wall portions. A first radius of curvature R1 is between the inner wall and the transition wall, a second radius of curvature R2 is between the transition wall and the outer wall, and a third radius of curvature R3 is at the middle reduced diameter region, with R1<R2 and R2≤R3.
A replacement leaflet valve is located in the central lumen of the inner wall. The unibody stent frame further comprises a plurality of longitudinal struts integrally formed with a plurality of circumferential struts, and each longitudinal strut is contiguously located along the inner wall, transition wall and outer wall.
Claims Coverage
The document includes one independent claim directed to a replacement heart valve with a unibody folded double-wall stent frame having specific wall-region geometry, curvature relationships, a tubular inner lumen for a leaflet valve, and integrally formed longitudinal and circumferential struts.
Folded double-wall unibody stent frame with collapsed and expanded configurations
A unibody stent frame with a folded double-wall, having a collapsed configuration and an expanded configuration.
Outer wall with downstream open enlarged, middle reduced, and upstream closed enlarged regions
An outer wall comprising a downstream open enlarged diameter region, a middle reduced diameter region, and an upstream closed enlarged diameter region.
Tubular inner wall with a central lumen and transition wall
A tubular inner wall with a central lumen and a transition wall between the upstream closed enlarged diameter region of the outer wall and the inner wall.
Curvature relationship across inner wall, transition wall, and outer wall regions
A first radius of curvature R1 between the inner wall and the transition wall, a second radius of curvature R2 between the transition wall and the outer wall, and a third radius of curvature R3 at the middle reduced diameter region, wherein R1<R2≤R3.
Replacement leaflet valve located in the central lumen of the inner wall
A replacement leaflet valve located in the central lumen of the inner wall.
Integrally formed longitudinal and circumferential struts spanning inner wall, transition wall, and outer wall
A plurality of longitudinal struts, wherein each longitudinal strut is contiguously located along the inner wall, transition wall and outer wall, and wherein the plurality of longitudinal struts are integrally formed with a plurality of circumferential struts.
Overall claim coverage centers on a replacement heart valve using a folded double-wall unibody stent frame with a regionally defined outer wall, a tubular inner lumen with a transition wall, specified curvature ordering, a leaflet valve in the inner lumen, and integrally formed longitudinal and circumferential struts contiguously spanning inner wall, transition wall, and outer wall.
Stated Advantages
Potential reduced outflow obstruction risk due to the decoupled geometry between retention/support from the double-wall design.
Structural integrity benefits.
Documented Applications
Mitral valve replacement delivery, including transseptal or transapical access concepts, with staged release to aid centering and orientation prior to complete release.
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