Prosthetic heart valve leaflet commissure assemblies and methods

Inventors

Bukin, Michael • Nir, Noam • Levi, Tamir S. • Yohanan, Ziv • Sherman, Elena • Goldberg, Eran • Maimon, David

Assignees

Edwards Lifesciences Corp

Abstract

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.

Core Innovation

The disclosure relates to prosthetic heart valve commissure assemblies in which leaflet commissure tabs are arranged to form commissures. An annular frame includes a plurality of commissure support portions, and a plurality of commissure support elements each include two axially-extending members spaced apart to form an open, leaflet-receiving window. Leaflets include a body and two opposing commissure tabs arranged on opposite sides of the body, where each commissure tab is arranged adjacent to a commissure tab of an adjacent leaflet to form a pair of commissure tabs disposed in a commissure support element to form a commissure.

Each commissure tab is arranged as a series of overlapping layers with a first set of two overlapping layers extending through the window of the commissure support element and a second set of two overlapping layers extending away from the first set and over an outer side of a corresponding axially-extending member. The overlapping-layer arrangement is specified in a lateral direction arranged tangent to a circumference of the prosthetic heart valve and perpendicular to a radial direction relative to a central longitudinal axis of the prosthetic heart valve. In assembly, the folded configuration places the overlapping layers within the window so that multiple overlapping layers are pressed together within the window and additional layers extend along an outer side and around an outer surface of the axially-extending member.

In some embodiments, the commissure support element further includes a coupling portion configured to couple to a corresponding commissure support portion of the annular frame, and the axially-extending members are radially offset from the coupling portion while laterally spaced apart to form the open leaflet-receiving window. The disclosure also describes reinforcement members that couple to the window or commissure support and hold the commissure tabs against the support to reduce abrasion and axial fold formation during valve cycling, and may enable attachment with reduced need for fasteners piercing the leaflets.

Claims Coverage

The partial content includes three independent claims covering layered commissure tabs within an open leaflet-receiving window, a method of assembling the valve by folding, pairing, suturing, and arranging the folded tabs in a window, and an alternative valve structure with a coupling portion and a detailed folded commissure tab arrangement. The inventive features center on commissure support elements forming an open leaflet-receiving window with two axially-extending members, commissure tabs configured as series of overlapping layers arranged through and over the support members, and specific folding and placement patterns within the window.

Across the independent claims in the partial content, the claims consistently require commissure support elements defining an open leaflet-receiving window by two axially-extending members, commissure tabs that form commissures by being arranged adjacent or paired between adjacent leaflets, and layered commissure-tab configurations in which first sets of overlapping layers extend through the window and second sets extend laterally along and over the axially-extending members. The method claim adds suturing via axially-extending lines of sutures, and the alternative structure claim adds a coupling portion and a folded tab arrangement with pressed overlapping layers within the window.

Stated Advantages

Documented Applications