Systems and methods for heart valve leaflet repair

Inventors

Chau, Mark • Shafigh, Sam • Oba, Travis Zenyo

Assignees

Edwards Lifesciences Corp

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Publication Number

US-12751818-B2

Patent

Publication Date

2026-10-06

Expiration Date


Abstract

An implant includes an interface and a wing that is coupled to the interface. A catheter is transluminally advanceable to a heart chamber upstream of a heart valve of a subject and houses the implant. A delivery tool comprises a shaft and a driver. Via engagement with the interface, the shaft is configured to (i) deploy the implant out of the catheter such that, within the chamber, the wing extends away from the interface; and (ii) position the implant in a position in which the interface is at a site in the heart and the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve. The driver is configured to secure the implant in the position by driving an anchor through the interface and into tissue at the site. Other embodiments are also described.

Core Innovation

The transcatheter heart-valve leaflet repair system comprises an implant having an interface, an anchor receiver at the interface, and a flexible wing coupled to the interface, together with an anchor, a catheter, and a delivery tool. The catheter houses the implant and is transluminally advanceable to a heart chamber upstream of the valve. The delivery tool deploys and positions the implant such that the wing extends over a first leaflet toward an opposing leaflet with its contact face facing the first leaflet.

The delivery tool includes a shaft housing the anchor that engages with the interface to deploy the implant, and a driver that secures the implant by driving a tissue-engaging element distally through the anchor receiver into tissue. The system supports and redirects an abnormal leaflet toward the opposing leaflet to restore coaptation and reduce regurgitation. The delivery tool permits positioning and repositioning before anchoring, as well as de-anchoring or retrieval.

Claims Coverage

The claims identify one independent claim covering four inventive features of a heart-valve system comprising an implant, an anchor, a catheter, and a delivery tool.

Implant with a flexible wing and anchor receiver

The implant comprises an interface, an anchor receiver at the interface, and a flexible wing coupled to the interface, wherein the wing includes a contact face facing the first leaflet and an opposing face, and extends over the first leaflet toward the opposing leaflet.

Catheter configured to house the implant

The catheter is transluminally advanceable to the heart chamber upstream of the valve and configured to house the implant.

Delivery tool shaft deploying and positioning the implant

The delivery tool comprises a shaft housing the anchor and engaged with the interface, configured to deploy the implant out of the catheter so the wing extends away from the interface and position the interface at a site in the chamber while the anchor remains within the shaft.

Driver securing the implant

A driver engaged with the anchor within the shaft secures the implant in position by driving a tissue-engaging element of the anchor distally through the anchor receiver and into tissue at the site.

The independent claim combines a catheter-delivered winged implant having an anchor receiver with a delivery tool that positions the wing over a leaflet and drives an anchor through the receiver to secure the implant to tissue.

Stated Advantages

The flexible wing redirects an abnormal leaflet toward the opposing leaflet to improve and restore coaptation and reduce regurgitation, including during valve closure.

Documented Applications

A catheter-delivered system for use with a heart valve of a subject having a first leaflet and an opposing leaflet, wherein the implant is transluminally delivered to a chamber upstream of the valve, positioned with the flexible wing extending over the first leaflet toward the opposing leaflet, and secured to tissue near the valve annulus.

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