Abstract: A prosthetic hemi heart valve for treatment of a diseased heart valve having native anterior and prosthetic posterior leaflets includes a sting-ray and crescent shaped stent with an extended tab configured to be a safety mechanism. At least one prosthetic leaflet mounted on an inner surface of the stent comprises a free edge, two commissure attachment regions, an attachment edge, a coaptation region, a belly region, and at least one leg structure coupling a portion of the leaflet(s) to a lower ventricular portion of the stent. A sealing skirt coupled to the inner surface of the stent to mount the leaflet(s) and create a paravalvular seal on the atrial portion of the prosthetic hemi valve. The prosthetic hemi heart valve further having a plurality of dual guiding and fixation members for anchoring the atrial flared portion of the stent to a posterior portion of the native valve annulus.

Abstract: A novel multi-stage and multi-lumen (MSML) delivery and implantation system for implanting a prosthetic heart valve for treatment of a diseased heart valve. The MSML delivery system comprises of a docking system, a dual-guiding-and-fixation (DGF) system for implanting a plurality of DGF members in the proximity of the annulus, a valve delivery system for releasing and locking a prosthetic valve, and a prosthetic valve having a crescent shaped stent, a plurality of DGF members, a plurality of leaflets comprising a free edge, two commissure attachment regions, an attachment edge, a coaptation region, a belly region, and at least one prong structure. The docking system, the DGF system, and the valve delivery system are configured cooperatively for advancing to an operative position, and for delivering and implanting a plurality of DGF head members to the operative position, and for guiding, delivering and fixating the prosthetic valve to the operative position.

Abstract: A transcatheter heart valve leaflet replacement system includes a valve prosthesis and a multi-stage, multi-lumen (MSML) heart valve delivery and implantation system for guiding and implanting the prosthesis to a native annulus. The prosthesis includes a stent frame including an upper atrial flared portion and a lower ventricular portion, a plurality of prosthetic leaflets, and at least one lining skirt. The prosthesis is configurable or otherwise sizable to fit in the MSML delivery and implantation system and to subsequently be selectively expanded to an operative size and position once deployed within the annulus. A portion of the prosthesis can be configured to couple with dual guiding and fixation (DGF) members to guide and fix the prosthesis to the annulus. In one aspect, the MSML delivery and implantation system includes a main docking system, a DGF member delivery system, and a valve housing, positioning, and locking system.