Abstract: A low-profile prosthetic hemi valve for treatment of a regurgitant heart valve. In one example, the prosthetic valve includes a large upper portion for anchoring in a dilated annulus, and a smaller open lower portion that is suspended in the blood flow path near the native leaflet coaptation line when implanted. The prosthetic valve includes at least one flexible prosthetic leaflet that moves between an open configuration to a closed position along with native leaflets of the valve. In operation, the at least one prosthetic leaflet serves as a conformable coaptation surface for at least one native leaflet, and the posterior side of the lower portion of the frame serves as a coaptation surface for at least one native leaflet to completely seal the native valve orifice. Optionally, the frame can comprise an open flow channel to enhance diastolic filling of the ventricle.

Abstract: A heart valve leaflet replacement system for a diseased heart valve including a replacement valve that is configured to be selectively guided and implanted in a native annulus of the diseased heart valve. The replacement valve can include: a frame with a rigid portion to house and maintain the integrity of the replacement leaflets and a flexible portion enabling it to conform to the native vessel geometry, at least one prosthetic leaflet coupled to an inner surface of the stent, and a plurality of prong structures operatively coupled to and extending between portions of the at least one prosthetic leaflet and the inner surface of the bottom ventricular portion of the stent to selectively constrain the movement of the at least one prosthetic valve relative to the bottom ventricular portion of the stent.

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 prosthetic heart valve for treatment of a diseased heart valve having native anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of a heart. The prosthetic heart valve having a crescent shaped stent, at least one prosthetic leaflet mounted on an inner surface of the stent, and at least one prong structure coupling a portion of the at least one prosthetic leaflet to a lower ventricular portion of the stent frame. The prosthetic heart valve further having systems for anchoring the upper flared portion of the stent to a posterior portion of the native valve annulus.

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.

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 prosthetic heart valve for treatment of a diseased heart valve having native anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of a heart. The prosthetic heart valve having a crescent shaped stent, at least one prosthetic leaflet mounted on an inner surface of the stent, and at least one prong structure coupling a portion of the at least one prosthetic leaflet to a lower ventricular portion of the stent frame. The prosthetic heart valve further having systems for anchoring the upper flared portion of the stent to a posterior portion of the native valve annulus.

Abstract: A heart valve leaflet replacement system for a diseased heart valve including a replacement valve that is configured to be selectively guided and implanted in a native annulus of the diseased heart valve. The replacement valve can include: a frame with a rigid portion to house and maintain the integrity of the replacement leaflets and a flexible portion enabling it to conform to the native vessel geometry, at least one prosthetic leaflet coupled to an inner surface of the stent, and a plurality of prong structures operatively coupled to and extending between portions of the at least one prosthetic leaflet and the inner surface of the bottom ventricular portion of the stent to selectively constrain the movement of the at least one prosthetic valve relative to the bottom ventricular portion of the stent.

Abstract: A prosthetic heart valve for treatment of a diseased heart valve having native anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of a heart. The prosthetic heart valve having a crescent shaped stent, at least one prosthetic leaflet mounted on an inner surface of the stent, and at least one prong structure coupling a portion of the at least one prosthetic leaflet to a lower ventricular portion of the stent frame. The prosthetic heart valve further having systems for anchoring the upper flared portion of the stent to a posterior portion of the native valve annulus.