Systems, devices and methods for folded unibody heart valve stents
Inventors
Wallace, Daniel T. • Boyette, Jeremy J. • Gregg, Peter W. • Noe, Spencer C. • Haynes, Evelyn N.
Assignees
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Publication Number
US-11197755-B1
Publication Date
2021-12-14
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 disclosed invention relates to a replacement heart valve having a unibody stent frame with a folded double-wall structure. The stent frame provides a collapsed configuration and an expanded configuration, and includes an outer wall and a tubular inner wall with a central lumen. A transition wall is positioned between an upstream closed enlarged diameter region of the outer wall and the inner wall, with a replacement leaflet valve located in the central lumen of the inner wall.
The folded double-wall geometry is defined by three radii of curvature that establish a relational constraint across the wall interfaces. 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. The radii satisfy R1<R2<R3, characterizing the geometry of the double-wall frame across the collapsed and expanded configurations.
The unibody stent frame further includes a plurality of longitudinal struts contiguously located along the inner wall, transition wall, and outer wall. The longitudinal struts are integrally formed with a plurality of circumferential struts, producing an integrated stent architecture. The disclosed content further describes chevron/barb-like retention features, control apertures, and stent covering and skirt structures formed with dual- or multi-material fabric structures to support tissue ingrowth and to provide thrombus resistance.
Claims Coverage
The partial content provides one independent claim, with inventive features centered on a unibody folded double-wall stent frame defining collapsed and expanded configurations, a specific outer-wall region geometry with three radii of curvature (R1<R2<R3), and an integrated longitudinal/circumferential strut architecture supporting a replacement leaflet valve in the central lumen.
Unibody folded double-wall stent with collapsed and expanded configurations
A unibody stent frame with a folded double-wall comprising a collapsed configuration and an expanded configuration, wherein the stent frame has an outer wall and 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.
Three radii of curvature satisfying R1<R2<R3 across wall interfaces
An outer-wall geometry defined by a downstream open enlarged diameter region, a middle reduced diameter region, and an upstream closed enlarged diameter region, and a transition wall and inner wall relationship characterized by 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, with the transition wall and outer wall positioned relative to the upstream closed enlarged diameter region and the inner wall.
Integrally formed longitudinal and circumferential struts contiguously along the walls
A plurality of longitudinal struts contiguously located along the inner wall, transition wall and outer wall, wherein the plurality of longitudinal struts are integrally formed with a plurality of circumferential struts.
Overall, the independent claim coverage is directed to a replacement heart valve where a unibody folded double-wall stent frame defines collapsed and expanded configurations, uses a three-radius outer/transition/inner wall geometric relationship with R1<R2<R3, supports a replacement leaflet valve in the inner-wall central lumen, and integrates longitudinal and circumferential struts as a single stent architecture.
Stated Advantages
Documented Applications
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