Systems, devices and methods for folded unibody heart valve stents
Inventors
Noe, Spencer C. • Wallace, Daniel T. • Haynes, Evelyn N. • Boyette, Jeremy J. • Gregg, Peter W.
Assignees
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Publication Number
US-12539209-B2
Publication Date
2026-02-03
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 is a replacement heart valve comprising a unibody stent frame with a folded double-wall, an outer wall with open and closed enlarged diameter regions and a middle reduced region, a tubular inner wall with a central lumen, and a transition wall. A replacement leaflet valve is located in the inner wall's lumen, with the transition wall upstream of the leaflet valve. The disclosure also describes skirts, sutures, and longitudinal struts associated with the frame.
The separated walls allow the valve-support geometry to differ from the geometry used for retention at the native annulus, while the inner wall can remain non-foreshortening and the outer wall can collapse for catheter delivery. The design addresses force concentrations associated with joined components and may reduce outflow-tract obstruction.
Claims Coverage
The claim coverage includes three inventive features corresponding to three independent claims.
Folded double-wall valve with suture and skirt
Claim 1 recites a replacement heart valve comprising a unibody stent frame with an outer wall having open and closed enlarged diameter regions and a middle reduced region, a tubular inner wall with a central lumen, and a transition wall between the closed enlarged diameter region and the inner wall. It further recites a suture extending over one or more exterior regions of the frame, a replacement leaflet valve in the central lumen, and a skirt with first and second structures covering specified outer-wall regions.
Folded double-wall valve with skirt
Claim 16 recites a replacement heart valve comprising a unibody stent frame with the specified outer wall, tubular inner wall, and transition wall upstream of the replacement leaflet valve in the inner wall's central lumen, along with a skirt comprising a first structure covering the outer surface of the open enlarged diameter region and a second structure covering the outer surface of the closed enlarged diameter region.
Folded double-wall valve with continuous longitudinal strut
Claim 22 recites a replacement heart valve comprising a unibody stent frame with the specified outer wall, tubular inner wall, transition wall upstream of the replacement leaflet valve, and a longitudinal strut contiguously located along the inner wall, transition wall, and outer wall having a non-uniform radial thickness and/or a non-uniform width.
The three independent claims cover the folded double-wall valve architecture and its leaflet valve, each specifying distinct claim elements directed to a suture and skirt, a skirt alone, or a continuous longitudinal strut with non-uniform dimensions.
Stated Advantages
The frame supports compact transcatheter delivery, with the outer wall collapsing for catheter delivery.
The design is stated to reduce force concentrations compared with joined components.
The design may reduce outflow-tract obstruction.
Documented Applications
A replacement heart valve, including implanted valve examples shown in the figures.
Catheter or transcatheter delivery of replacement heart valves.
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