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 a coaptation assist implant and a coaptation assist system for treating mal-coaptation of a mitral valve regurgitation heart valve. The coaptation enhancement uses a coaptation assist body having a first coaptation surface and a second surface, with the surfaces extending laterally and longitudinally along the coaptation assist body.

The implant is positioned within the blood flow path between native leaflets to create opposed coaptation surfaces intended to seal mal-coapting segments without leaflet fusion or annular reshaping. The coaptation assist body is described as laterally/axially conformable and thin elongate, with a curved funnel-like coaptation geometry defining a coaptation zone curve.

The coaptation assist system includes a primary anchor configured to secure the coaptation body to the valve annulus, and one or more secondary anchors spaced apart laterally from the primary anchor. The anchors are described as separately deployed independent anchors near mitral commissures, and optionally a ventricular anchor, to enable accurate positioning and support during a beating-heart procedure.

The document further describes optional structure and formation features, including an outer ePTFE layer over a swelling fluid-absorbing matrix/foam for shape formation, optional adjustable curvature using an eccentric tether within an axial channel constrained by a curvature lock, and catheter steerability with hemodynamic verification and replacement capability during deployment.

Claims Coverage

The independent claims (three total: clm-00001, clm-00010, and clm-00016) define a coaptation assist system for treating mal-coaptation of a heart valve using a coaptation assist body having first and second surfaces, a primary anchor to anchor the body to the valve annulus, and secondary anchors with specified spacing/arrangement and, in one claim, separately deployable helical anchors.

Across the independent claims, the core claim coverage centers on a coaptation assist body with first and second surfaces and a primary anchor secured to the valve annulus, together with laterally spaced secondary anchors; additional independent-claim-specific structure includes two secondary anchors on opposite sides of the primary anchor, and in another case separately deployable helical primary and secondary anchors driven into tissue.

Stated Advantages

Documented Applications