Coaptation enhancement implant, system, and method

Inventors

Khairkhahan, Alexander • Lesh, Michael D.

Assignees

Polares Medical Inc

Abstract

Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.

Core Innovation

The invention relates to an implant for treating mal-coaptation of a heart valve of a patient, where the heart valve includes an annulus, an anterior leaflet, and a posterior leaflet. The implant includes a valve body having a triangular configuration with an atrial end, a ventricular end, and right and left lateral edges tapering inwardly toward the ventricular end.

The valve body includes front and back surfaces configured for placement toward the anterior leaflet and the posterior leaflet, respectively, with the front surface configured to coapt with the front surface. The valve body is characterized by an axial length from the atrial end to the ventricular end, at least one lateral width between the right and left lateral edges, and at least one thickness between the front and back surfaces.

The valve body includes localized variations in thickness between the front and back surfaces, so that the geometry of the valve body is configured to address mal-coaptation by shaping the coaptation-related surfaces. In a further aspect, the implant includes a protrusion extending from the front surface of the valve body, where the protrusion is configured to engage the anterior leaflet and enhance sealing of the heart valve.

Claims Coverage

The document provides two independent claims directed to a mal-coaptation treatment implant. Across the independent claims, the main inventive features are a triangular valve body with defined geometry and localized thickness variations, and a triangular valve body with a front-surface protrusion of variable thickness configured to engage the anterior leaflet and enhance sealing.

The claim set centers on a triangular implant valve body with front and back surfaces for anterior and posterior leaflet coaptation, combined with defined axial length, lateral width, thickness, and localized thickness variations to treat mal-coaptation. A second independent claim adds a front-surface protrusion of variable thickness configured to engage the anterior leaflet and enhance sealing.

Stated Advantages

Documented Applications