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-12171657-B2

Patent

Publication Date

2024-12-24

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 heart valve that includes a valve component and a stent component for housing the valve component. The stent component has an inflow end and an outflow end, with the outflow end including a plurality of arches and a plurality of valve fixation elements. The valve fixation elements each have first and second sets of two generally parallel sides and at least one transverse member extending between the two generally parallel sides of one of the first and second sets to define at least first and second openings for securing the valve component to the stent component.

A fabric skirt covers at least a portion of an outer surface of the valve component, where the fabric skirt serves as a sealing member between the stent component and the valve component. In the outflow region, the arches and the valve fixation elements define the structure that secures the valve component to the stent component. In additional refinements described in the provided content, the stent component can include three arches and three valve fixation elements, and the valve fixation elements can be generally rectangular with a length greater than a width.

The provided content also describes stent inflow/outflow structural subfeatures, including an inflow end having struts forming a plurality of diamonds, and an outflow end including arches and the plurality of valve fixation elements. In at least one configuration, the valve component comprises mammalian tissue, and the plurality of valve fixation elements connect the plurality of arches to the plurality of diamonds. In at least one described configuration, an outer-surface topology on an outer skirt is configured to enhance endothelialisation, including an arrangement in which an inner skirt and an outer skirt together form a double fabric skirt covering an inflow edge of a stent component.

Claims Coverage

The independent claims are clm-00001, clm-00015, and clm-00020, and they share core features of a valve component housed in a stent component and a fabric skirt serving as a sealing member. Across these independent claims, the main inventive features include arch-based valve fixation using transverse-member-defined openings, specific stent inflow/outflow structures (diamonds and arches), and fixation-element geometry including generally rectangular elements with length greater than width.

Arch-based valve fixation elements with transverse-member openings

A replacement heart valve including a valve component; a stent component having an inflow end and an outflow end, where the outflow end includes a plurality of arches and a plurality of valve fixation elements, each valve fixation element defined by first and second sets of two generally parallel sides and at least one transverse member extending between the two generally parallel sides to define at least first and second openings for securing the valve component to the stent component.

Fabric skirt sealing between stent component and valve component

A replacement heart valve where a fabric skirt covering at least a portion of an outer surface of the valve component serves as a sealing member between the stent component and the valve component.

Mammalian-tissue valve component with diamond inflow structure and arch outflow fixation

A replacement heart valve where the valve component comprises mammalian tissue; the stent component includes an inflow end having struts forming a plurality of diamonds, and an outflow end including a plurality of arches and a plurality of valve fixation elements, with each valve fixation element having an outer polygon frame and at least one transverse member extending between two opposing sides of the polygon frame to define at least first and second openings for securing the valve component to the stent component.

Fixation elements connecting arches to diamonds with generally rectangular length-greater-than-width geometry

A replacement heart valve where the stent component includes an inflow end including struts forming a plurality of diamonds and an outflow end including a plurality of arches; the plurality of valve fixation elements connect the plurality of arches to the plurality of diamonds; each valve fixation element is generally rectangular with a length greater than a width, the length extending parallel to a longitudinal axis of the stent component; and each valve fixation element includes at least one transverse member extending across its width to define at least first and second openings within the valve fixation element for securing the valve component to the stent component.

Collectively, the independent claims cover a replacement heart valve with a valve component housed on a stent component, an arch-based fixation structure using transverse-member-defined openings to secure the valve component, a fabric skirt that serves as a sealing member between the stent and valve components, and in some configurations an inflow diamond structure and outflow arch structure with fixation elements connecting arches to diamonds and having generally rectangular length-greater-than-width geometry.

Stated Advantages

Fabric skirt serves as a sealing member between the stent component and the valve component.

Outer-surface topology on an outer skirt is configured to enhance endothelialisation.

Documented Applications

Replacement heart valve configurations using a stent component and a fabric skirt serving as a sealing member between the stent component and the valve component.

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