Transcatheter valve leaflet replacement device, delivery, guiding and fixation system and method for same

A heart valve leaflet replacement delivery system for treatment of a diseased heart valve within a patient's body, the system comprising:

• a prosthetic valve comprising a stent including an upper flared portion and a lower portion and at least one prosthetic leaflet, the stent comprising a plurality of through-holes in the upper flared portion;
• a plurality of dual-guiding and fixation (DGF) members;
• and
• a multi-stage, multi-lumen (MSML) delivery system comprising a dual-guiding-and-fixation (DGF) delivery system and a valve housing, positioning, and locking (VHPL) system configured cooperatively for advancing to an operative position, and for delivering and implanting the plurality of DGF members to the operative position, and for guiding, delivering, and fixing the prosthetic valve to the operative position;
• wherein each of the plurality of DGF members comprises a head portion including a sharpened tip configured to be embedded in tissue, a body portion including a fixation mechanism, and a tail portion that extends from the body portion to a proximal end of the MSML system comprising a tether;
• the DGF delivery system configured to implant the plurality of DGF members in a native annulus such that one end of each tail portion is attached to the respective body portion and the other end of each tail portion exits the patient's body to aid in guiding and fixing the prosthetic valve, the tail portions extending from the body portions to a proximal side of the DGF delivery system to guide prosthetic valve delivery via the plurality of through-holes;
• and
• the VHPL system configured to track over the tail portions to a desired implantation location at the previously implanted plurality of DGF members, and incrementally release the prosthetic valve from a crimped state starting with a proximal-most portion of the prosthetic valve and moving to a distal-most portion of the prosthetic valve, and fix the prosthetic valve to the plurality of DGF members via the respective fixation mechanisms,
• wherein the body portion of each of the plurality of DGF members is configured to attach to the respective head portion and resist separation, and each body portion is configured with a plurality of engagement structures designed to engage with the DGF delivery system, and comprises a plurality of passages, wherein at least one passage of the plurality of passages is configured for securing the respective fixation mechanism to the respective body portion, and at least one other passage of the plurality of passages is for attaching a stabilization member.