Commissure attachment for prosthetic heart valve
Inventors
Levi, Tamir S. • Nir, Noam • Bukin, Michael • Maimon, David • Yushtein, Haim
Assignees
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Publication Number
US-12433747-B2
Publication Date
2025-10-07
Expiration Date
Abstract
A prosthetic heart valve includes an annular frame that is radially collapsible and radially expandable, a plurality of leaflets situated within the frame, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure, and a plurality of post members mounted on an interior surface of the frame. The at least one commissure includes a commissure attachment assembly including a support member disposed at least partially around the commissure tab portions and the commissure tab portions are folded around the support member. The commissure attachment assembly is secured to a first post member of the plurality of post members such that the commissure tab portions are positioned between the first post member and the support member.
Core Innovation
The invention relates to a prosthetic heart valve having an annular frame including interconnected strut members, where the frame is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A plurality of leaflets are situated within the frame, and each leaflet includes opposing commissure tab portions on opposite sides of the leaflet. The commissure tab portions are paired with adjacent commissure tab portions of adjacent leaflets to form at least one commissure.
Each commissure comprises a commissure attachment assembly that includes a support member with a central opening disposed at least partially around the commissure tab portions. The commissure tab portions extend through the central opening of the support member, and the commissure tab portions are folded around the support member and away from each other. The commissure attachment assembly is secured to a first post member mounted on an interior surface of the frame such that the support member aligns in the radial direction with the first post member and the commissure tab portions are positioned between, in the radial direction, the first post member and the support member.
In further embodiments, the support member includes a central opening bound by side portions, an upper portion, and a lower portion, and the support member includes a flexible material configured to bend in a radially inward or outward direction relative to a central longitudinal axis of the frame. The side portions apply a clamping force against the commissure tab portions arranged within the central opening. In additional embodiments, retaining members with prong members are attached to each post member, where commissure tab portions extend through respective pairs of retaining members such that the commissure tab portions are folded away from one another and each commissure tab portion is positioned radially between a retaining member and the post member.
Claims Coverage
Independent claim coverage is provided by clm-00001, clm-00012, clm-00020 (method), and clm-00023. Across these independent claims, the main inventive features include commissure tab portions paired across adjacent leaflets, a commissure attachment assembly with a support member having a central opening through which tab portions extend, state-dependent bending and clamping structures secured to interior post members, and a method of assembling the commissure attachment by inserting tabs through a relaxed support member opening followed by bending to exert a clamping force.
Radially collapsible and expandable annular frame with commissure tab portions paired across leaflets
An annular frame including a plurality of interconnected strut members, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration; a plurality of leaflets situated within the frame, each leaflet comprising opposing commissure tab portions on opposite sides of the leaflet; each commissure tab portion being paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure.
Support member with central opening disposed around commissure tab portions
A commissure attachment assembly comprising a support member, the support member comprising a central opening disposed at least partially around the commissure tab portions such that the commissure tab portions extend through the central opening of the support member.
Folded commissure tab portions and radial alignment between support member and post member
The commissure tab portions of the commissure attachment assembly are folded around the support member and away from each other; the commissure attachment assembly is secured to a first post member such that the support member is aligned in the radial direction with the first post member and the commissure tab portions are positioned between, in the radial direction, the first post member and the support member.
Support member disposed completely around tabs and clamping force applied by side portions
A commissure attachment assembly comprising a support member disposed completely around the commissure tab portions such that the commissure tab portions extend through a central opening of the support member; the central opening is bound by two side portions disposed on opposite sides of the central opening; and the two side portions apply a clamping force against the commissure tab portions arranged within the central opening.
Flexible support member configured to bend radially inward or outward to clamp
At least a portion of the support member comprises a flexible material and is configured to bend in a radially inward or outward direction relative to a central longitudinal axis of the frame.
Method: insert paired commissure tabs through a relaxed central opening and bend side portions to clamp
Pairing a first commissure tab of a first leaflet with a second commissure tab of a second leaflet; inserting the paired first commissure tab and second commissure tab into and through a central opening of a support member that is in a relaxed state; securing the support member to a post member mounted on an interior surface of the frame; and after inserting the tabs through the opening, bending each of the two side portions of the support member in an outward radial direction toward the post member and moving inner edges of the central opening toward each other in order to exert a clamping force against portions of the first and second commissure tabs arranged therein.
Retaining-member pair per post with prong member offset and folding commissure tab portions through retaining members
A pair of retaining members attached to each post member, the pair of retaining members spaced apart from each other, wherein each retaining member comprises a base portion directly attached to the post member and a prong member that extends from the base portion toward the outflow end of the frame, wherein the prong member is offset from the post member in a radial direction relative to a central longitudinal axis of the frame, and wherein an end of the prong member opposite the base portion is unattached to the post member and configured to be urged radially toward the post member; each pair of commissure tab portions extends through a respective pair of retaining members such that the pair of commissure tab portions are folded away from one another and each commissure tab portion is positioned radially between a respective retaining member of the pair of retaining members and the respective post member.
Overall, the independent claims cover commissure formation from paired commissure tab portions across adjacent leaflets, retention by a support member with a central opening secured to interior post members, and mechanisms that fold tabs and apply clamping force either via a flexible, radially bending support member or via retaining-member pairs with prong members that urge and position folded tabs between the retaining members and the post members. The method claim focuses on assembling the commissure attachment by inserting tabs through a relaxed support member opening and then bending side portions to move inner edges toward each other to exert a clamping force.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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