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

Occam Labs LLC • Capstan Medical Inc

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Publication Number

US-11759319-B2

Patent

Publication Date

2023-09-19

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 lasercut expanded tubular unibody stent frame with an everted double-wall. The stent frame includes a collapsed configuration and an expanded configuration and defines an outer wall and a tubular inner wall with a central lumen. A replacement leaflet valve is located in the central lumen of the inner wall.

The outer wall is defined with a downstream open enlarged diameter region, a middle reduced diameter region, and an upstream closed enlarged diameter region. A transition wall connects the upstream closed enlarged diameter region of the outer wall to the inner wall.

The stent frame further includes a plurality of longitudinal struts that are contiguously located along the inner wall, transition wall, and outer wall, and the longitudinal struts are integrally formed with a plurality of circumferential struts.

Claims Coverage

The independent claim covers a replacement heart valve with a lasercut expanded tubular unibody stent frame featuring an everted double-wall and a defined inner/transition/outer wall architecture, with integrated longitudinal and circumferential struts supporting a replacement leaflet valve located in the inner-wall central lumen. The independent claim identifies five inventive features.

Everted unibody double-wall stent frame with collapsed and expanded configurations

A lasercut expanded tubular unibody stent frame with an everted double-wall, comprising a collapsed configuration and an expanded configuration.

Outer wall with upstream, middle, and downstream diameter 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 defining a central lumen for a replacement leaflet valve

A tubular inner wall with a central lumen, wherein a replacement leaflet valve is located in the central lumen of the inner wall.

Transition wall connecting the upstream outer wall region to the inner wall

A transition wall between the upstream closed enlarged diameter region of the outer wall and the inner wall.

Contiguously located longitudinal struts integrally formed with circumferential struts

A plurality of longitudinal struts, wherein each longitudinal strut is contiguously located along the inner wall, transition wall and outer wall, and the plurality of longitudinal struts are integrally formed with a plurality of circumferential struts.

Overall, the claim coverage centers on a unibody everted double-wall stent frame that defines distinct inner and outer wall regions connected by a transition wall, with the replacement leaflet valve positioned in the inner-wall central lumen and with integrated longitudinal and circumferential strut structure spanning the inner wall, transition wall, and outer wall.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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