A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

The invention relates in some aspects to a device for use in anchoring an implant, including anchors, sutures, implants, clips, tools, lassos, and methods of anchoring among other methods. Anchors as disclosed herein could be utilized to secure a coaptation assistance device, an annuloplasty ring, an artificial valve, cardiac patch, sensor, pacemaker, or other implants. The implant could be a mitral valve ring or artificial mitral valve in some embodiments.

An apparatus for stabilizing a prosthetic heart valve within an atrioventricular valve includes a collapsible and expandable stent having an inflow end, an outflow end, and struts forming a plurality of cells connected to one another in a plurality of annular rows around the stent. The stent further includes a collapsible and expandable valve assembly secured to the stent. The valve assembly includes a cuff and a plurality of leaflets having an open configuration and a closed configuration. A cord connected to the stent includes an attachment device adapted to couple the stent to heart tissue of a patient. A method of stabilizing a prosthetic heart valve within an atrioventricular valve annulus is also described.

This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In some implementations, a heart valve leaflet clipping mechanism includes a delivery apparatus and clipping arms. The clipping arms are coupled to the delivery apparatus. The clipping arms are movable between an open position and a closed position. The two clipping arms are biased to the closed position. The delivery apparatus is configured to hold the clipping arms in the open position. The delivery apparatus is configured to allow the clipping arms to move to the closed position to engage native heart valve leaflet tissue.

A system for reducing regurgitation includes a catheter and a coaptation member disposed along a distal end portion of the catheter, wherein the coaption member is sized to be advanced through a patient’s vasculature in a compressed configuration and wherein the coaptation member is expandable for deployment between leaflets of a native tricuspid valve. The coaptation member includes a frame covered with one or more panels of bioprosthetic tissue or flexible polymer to form a three-sided shape having three convex sides separated by rounded corners. An anchor is coupled to a proximal end portion of the catheter and is shaped for attachment to a vessel wall. After deployment, the anchor secures the position of the coaptation member relative to the native tricuspid valve.

Implantable devices formed of materials which are not readily imageable are delivered and deployed with a deployment/delivery device having one or more sensors generating a signal indicating a condition of the implantable device relative to the deployment site. For instance, the signal indicates at least one or more of the following: purchase of the implantable device with tissue, level of purchase of the implantable device with tissue, the position of the implantable device relative to the deployment site, seating of tissue with respect to the implantable device, extent of contact of the implantable device with tissue, or further information about the implantable device and/or the delivery/deployment device. As such, the implantable device need not be imaged to determine the relationship of the implantable device relative to the deployment site.

An implant includes an interface and a wing that is coupled to the interface. A catheter is transluminally advanceable to a heart chamber upstream of a heart valve of a subject and houses the implant. A delivery tool comprises a shaft and a driver. Via engagement with the interface, the shaft is configured to (i) deploy the implant out of the catheter such that, within the chamber, the wing extends away from the interface; and (ii) position the implant in a position in which the interface is at a site in the heart and the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve. The driver is configured to secure the implant in the position by driving an anchor through the interface and into tissue at the site. Other embodiments are also described.

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.

A method for placing a transcatheter stent-valve having replacement leaflets that are attached along their free edges. The stent-valve frame has supports that extend distally of the replacement leaflets to fastening sites. The replacement leaflets are attached along a leaflet base forming a linear attachment to the stent-valve frame. The free edges of the leaflets have cords attached; the cords attach the leaflets to the supports. The stent-valve can be a single component stent-valve or it can be a second component that attaches to a first component or dock.

Prosthetic heart valves described herein can be deployed using a transcatheter delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native heart valve. Some embodiments of prosthetic valves described herein include an anchor portion that couples to the anatomy near a native valve, and a valve portion that is mateable with the anchor portion. In some such embodiments, the anchor portion and/or the deployment system includes one or more prosthetic elements that temporarily augment or replace the sealing function of the native valve leaflets.