Stents, valved-stents and methods and systems for delivery thereof

Inventors

Essinger, JacquesDelaloye, SergeHefti, Jean-LucDelaloye, Stephane

Assignees

Symetis SA

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Publication Number

US-11452598-B2

Patent

Publication Date

2022-09-27

Expiration Date


Abstract

Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

Core Innovation

The invention relates to a replacement valve for use within a human body that includes a valve component comprising mammal pericardium tissue and a stent component for housing the valve component. The replacement valve further includes an inner fabric skirt covering at least a portion of an outer surface of the valve component, where the inner fabric skirt serves as a sealing member between the stent component and the valve component.

The inner fabric skirt covers between 50% and 90% of the stent, and the inner and outer fabric skirts are configured to form a double fabric skirt which covers the inflow edge of the stent component. The replacement valve also includes an outer fabric skirt covering an outer surface of the stent component, where the outer fabric skirt serves as a sealing member between the stent component and the native valve.

The topology of the outer surface of the outer fabric skirt is configured to improve endothelialization. In the disclosed embodiments, the valve component is housed by a multi-section stent used for minimally invasive valve replacement, including transapical or transvascular delivery, with stepwise distal-to-proximal deployment.

A disclosed stent-valve architecture includes a multi-section stent having at least four sections including a proximal conical section, a second conical section, a third section optionally providing cylindrical reinforcement and valve fixation, and a distal conical/orientation section. Radiopaque markers are provided for rotational orientation relative to coronary arteries, and a coaxial inner/outer delivery system with a sheath constrains and releases the stent-valve.

Claims Coverage

The partial content explicitly provides one independent claim directed to a replacement valve for use within a human body, with multiple dependent claims refining the construction. The inventive features emphasized in the independent claim are the combined use of mammal pericardium with a stent component, and a double fabric skirt in which an inner skirt serves as a sealing member between the stent and the valve component, and an outer skirt serves as a sealing member between the stent and the native valve, with topology configured to improve endothelialization and coverage constraints for the inner skirt.

Replacement valve with pericardium valve component in a stent

A replacement valve for use within a human body comprising a valve component comprising mammal pericardium tissue and a stent component for housing the valve component.

Inner fabric skirt sealing member covering a portion of the stent

An inner fabric skirt covering at least a portion of an outer surface of the valve component, wherein the inner fabric skirt serves as a sealing member between the stent component and the valve component, wherein the inner fabric skirt covers between 50% and 90% of the stent.

Outer fabric skirt sealing member with topology configured to improve endothelialization

An outer fabric skirt covering an outer surface of the stent component, wherein the outer fabric skirt serves as a sealing member between the stent component and the native valve, wherein the topology of the outer surface of the outer fabric skirt is configured to improve endothelialization.

Double fabric skirt covering the inflow edge

The inner and outer fabric skirt form a double fabric skirt which covers the inflow edge of the stent component.

Self-expanding stent component

The replacement valve includes a self-expanding stent component.

Balloon-expandable stent component

The replacement valve includes a balloon-expandable stent component.

Inner fabric skirt sutured to inflow tract and inner stent surface

An inner fabric skirt is sutured to the inflow tract of the valve component and to the inner surface of the stent component.

Polyethylene terephthalate skirt material

The polyester is polyethylene terephthalate.

Outer fabric skirt covering aortic-annulus-fitting stent portion

The outer fabric skirt covers a portion of a stent component shaped and sized to fit against the aortic annulus.

Across the independent claim and its provided dependents, the claim coverage centers on a pericardium-based replacement valve housed in a stent, where a double fabric skirt provides sealing between the stent and the valve component and between the stent and the native valve, with outer skirt topology configured to improve endothelialization and with the inner skirt covering 50% to 90% of the stent and covering the inflow edge as part of the double skirt.

Stated Advantages

Improve endothelialization.

Documented Applications

No documented applications found

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