Systems, methods and devices for prosthetic heart valve with single valve leaflet

Inventors

Chambers, Jeffrey W. • Kumar, Saravana B. • Higgins, Joseph P. • Thatcher, Robert J. • Diedering, Jason S. • Stone, Jeffrey R.

Assignees

4C Medical Technologies Inc

Abstract

Devices and methods for supplementing and/or replacing native cardiac valve functionality, e.g., the mitral valve with a single prosthetic leaflet. An exemplary device is directed to dysfunctional mitral valves. In some cases, the entire device, including the single prosthetic leaflet, will be arranged entirely above the dysfunctional mitral valves and, therefore, disposed entirely within the left atrium. In other cases, the valve support and/or single prosthetic leaflet may extend a distance into the annulus between the left atrium and left ventricle. In some cases, the device will not physically interact with the native leaflets. In other cases, the device may physically interact with the native leaflets.

Core Innovation

The disclosed invention relates to systems and devices for supplementing and/or replacing function of dysfunctional native mitral valve leaflets disposed within an annulus located between a left atrium and a left ventricle. The device is a prosthetic mitral valve device adapted to anchor within a left atrium of a heart using an expandable anchoring structure defining a lower opening.

A single prosthetic leaflet is operatively engaged with the expandable anchoring structure at the lower opening and comprises an upper surface. In a closed position, the upper surface directly engages a lower surface of a first base side to cover the lower opening and prevent retrograde blood flow resulting from the dysfunctional native mitral valve leaflets, and in an open position the single prosthetic leaflet rotates away from the first base side to allow blood to flow through the lower opening.

The disclosure further includes embodiments positioning and/or spacing the prosthetic leaflet relative to native leaflets to avoid physical interference or, in other embodiments, support within the annulus that pins native leaflets. Additional embodiments include a rotatable leaflet member with a flexion point and optional biasing to a closed position, a super-annular valve support configuration using a temporary seal via a small lip structure, and optional therapeutic-agent delivery on the prosthetic device for localized treatment.

Claims Coverage

The independent claim covers a prosthetic mitral valve device with a left-atrial anchored expandable anchoring structure and a single prosthetic leaflet that rotates between closed and open positions to prevent retrograde blood flow.

Overall, the claim coverage centers on an expandable anchoring structure with a lower opening, a base-side arrangement, and a single prosthetic leaflet that directly covers the lower opening in a closed position to prevent retrograde blood flow and rotates away in an open position to allow forward flow.

Stated Advantages

Documented Applications

No documented applications found