Abstract: A rod (508) is transfemorally advanceable to the heart. An implant (460) comprises (i) a first frame (462), compressed around a first longitudinal site of a distal portion of the rod, (ii) a second frame (464), compressed around a third longitudinal site of the distal portion, (iii) a valve member (50), disposed within the second frame, and (iv) a flexible sheet (466), coupling the first frame to the second frame, and disposed around a second longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site. An extracorporeal controller (569) is coupled to a proximal portion of the rod, and is operably coupled to the distal portion of the rod. Operating the controller bends the distal portion of the rod causing articulation between the frames. Other embodiments are also described.

Abstract: A tool (410) for use with an implant (20) includes a housing (426) and a controller (440). The housing includes a tubular wall (428) that circumscribes a longitudinal axis; is dimensioned to house at least part of the implant; and defines a track (430) that follows a generally-helical path around the longitudinal axis. The controller includes a rod (442) that extends from a proximal part of the tool to the housing; and an actuator (444). The actuator is fixedly coupled to the rod, includes an engaging element (446) that engages the track, and is rotatable with respect to the housing. The controller and the housing mechanically cooperate such that rotation of the actuator with respect to the housing slides the housing longitudinally with respect to the actuator. Other embodiments are also described.

Abstract: Embodiments of the present disclosure are directed to prosthetic heart valves and methods of use thereof. In one implementation, a prosthetic heart valve may include an annular spacer having a spacer opening therein and a disc-shaped wall configured to obstruct blood flow. The annular spacer may be configured for engaging with a native heart valve opening, such as the orifice of a mitral valve. The spacer opening may be sized to be smaller than the native heart valve opening. The prosthetic heart valve may also include a central valve section configured for disposal within the spacer opening. The central valve section may be separate from the annular spacer and may include one or more prosthetic valve leaflets.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a method of releasing a valve from a delivery capsule in a heart may be provided. The method may include moving a distal capsule portion of the delivery capsule a first distance in the heart in a first direction. Such movement may release ventricular anchoring legs of the valve from the capsule. The method may also include moving a proximal capsule portion of the delivery capsule a second distance in a second direction in the heart. The first direction may be opposite the second direction. Such movement may release atrial anchoring arms of the valve from the capsule. The method may also include moving the distal capsule portion a third distance in the first direction in the heart, to thereby release an annular valve body of the valve from the capsule.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a prosthetic valve may include an annular valve body and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. At least one ventricular anchoring leg may include a first concave portion situated between the valve body and a terminal end of the leg, and a second concave portion situated between the first concave portion and the terminal end of the leg. The first concave portion may face radially outward, while the second concave portion may face radially inward. At least one of the first concave portion and the second concave portion may be angularly aligned with a point of connection between the at least one leg and the valve body.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a method of implanting a prosthetic valve within a native mitral valve may be provided. The method may include delivering the prosthetic valve into a heart chamber. The prosthetic valve may be constrained in a contracted delivery configuration. The prosthetic valve may include an annular valve body with a plurality of ventricular anchors and a plurality of atrial anchors attached thereto. The method may also include unconstraining the plurality of ventricular anchors and the plurality of atrial anchors while maintaining the valve body in the contracted delivery configuration. The method may also include unconstraining the valve body from the contracted delivery configuration while the unconstrained atrial anchors are positioned within an atrium and while the unconstrained ventricular anchors are positioned within a ventricle.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body having an atrial end, a ventricular end, and an intermediate portion between the atrial end and the ventricular end. Atrial anchoring arms and ventricular anchoring legs may extend from the intermediate portion of the valve body. At least one atrial anchoring arm may extend radially outward beyond a terminal end of at least one ventricular anchoring leg. The atrial arms and the ventricular legs may be devoid of lateral interconnections therebetween beyond locations of connection to the intermediate portion. At least one atrial anchoring arm may extend in the generally radially outward direction from a single location of connection to the intermediate portion of the valve body.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, an annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs configured to extend therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are substantially parallel to a longitudinal axis of the valve body, and a deployed configuration, in which they may deflect radially outward. The anchoring arms may include a pivoting portion configured to extend in a non-ventricular direction when the arm is in the delivery configuration and in a ventricular direction when the arm is in the deployed configuration. The entire length of each leg may be configured to extend in a non-ventricular direction when the legs are in both the delivery and deployed configurations.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, an expandable annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs extending radially outward therefrom. At least one atrial anchoring arm may include a rigid portion and a flexible portion positioned radially outwards from the rigid portion. At least part of the flexible portion may be configured for placement at a location radially outward from an outer diameter defined by terminal ends of the ventricular anchoring legs.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, an expandable annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs extending therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are radially constrained, such as within a delivery device, and a deployed configuration, in which they may deflect radially outward. The anchoring legs may deflect radially outward by less than 90° when transitioning from the delivery configuration to the deployed configuration. Portions of the anchoring arms may deflect radially outward by at least 90° when transitioning from the delivery configuration to the deployed configuration.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, an expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may be expandable from a radially contracted state to a radially expanded state. The prosthetic valve may include an expandable outer frame and an inner frame with tissue anchors extending therefrom. The outer and inner frames may be configured and interconnected such that ventricular ends of the inner and outer frames are substantially aligned when the frames are in the radially expanded state and are not substantially aligned when the frames are in the radially contracted state.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a prosthetic valve may include an annular outer frame formed at least partially of struts intersecting at outer frame junctions and an inner frame situated within the outer frame. The inner frame may be formed at least partially of struts intersecting at inner frame junctions. The valve may include at least one inner frame tissue anchor extending from an inner frame junction. Outer frame junctions along a ventricular end of the outer frame may be angularly offset from inner frame junctions along a ventricular end of the inner frame.

Abstract: Apparatus for regulating blood flow of a subject is provided, the apparatus comprising a prosthetic valve (20) that comprises a tubular element (22), shaped to define a lumen (23) therethrough, and a valve member (24), configured to be coupled to the tubular element (22) and to be disposed within the lumen (23). The prosthetic valve (20) has (1) a compressed configuration in which the lumen (23) has a compressed width, the valve member (24) is generally cylindrical, and the prosthetic valve (20) is configured to be percutaneously delivered into the subject, and (2) an expanded configuration in which the lumen (23) has an expanded width that is greater than the compressed width, and the valve member (24) is generally disc-shaped, is coupled to the tubular element (22), and is disposed within the lumen (23). Other embodiments are also described.

Abstract: In an unfolded state, a sheet defines a panel at a medial region, and tab portions disposed peripherally to the panel. A method comprises (A) sandwiching, between a first tab portion and a second tab portion, (i) a first commissural portion of a first leaflet, and (ii) a second commissural portion of a second leaflet; (B) attaching the first tab portion and the second tab portion to the sheet by stitching a first stitching through the tab portions and the commissural portions; (C) subsequently, covering the first stitching by: (i) forming the first tab portion into a first tab having an outer layer and an inner layer, and (ii) forming the second tab portion into a second tab having an outer layer and an inner layer; and (D) subsequently, stitching a second stitching through the outer and inner layers, and the commissural portions. Other embodiments are also described.

Abstract: Apparatus and methods are described including a prosthetic atrioventricular valve (10) for coupling to a native atrioventricular valve (12). The prosthetic valve includes a support frame (20) and a covering (22), which at least partially covers the support frame. The support frame and the covering are shaped so as to define a downstream skirt (24). A plurality of prosthetic leaflets (40) are coupled to at least one element selected from the group consisting of: the support frame and the covering. An elongated anchoring member (152) is positioned around the downstream skirt in a subvalvular space (150), such that the anchoring member presses native leaflets (30) of the native valve against the downstream skirt, thereby anchoring the prosthetic valve to the native valve. Other applications are also described.

Abstract: Apparatus and methods are described including a prosthetic valve support (40) configured to be placed at a patient's native atrioventricular valve annulus. The valve support defines an annular element (44) that defines an inner cross-sectional area thereof. An expandable prosthetic valve (80) is placed into the patient's ventricle, the prosthetic valve including an expandable frame (79) and prosthetic valve leaflets (82) coupled to the frame. When the frame is in a non-constrained state thereof, a cross-sectional area of the frame, along at least a given portion L of the frame's length, is greater than the cross-sectional area defined by the annular element. The prosthetic valve is couplable to the prosthetic valve support at any location along the portion, by the frame being expanded when the location along the portion is aligned with the annular element. Other applications are also described.

Abstract: Apparatus is provided, including: (1) a delivery tube, transluminally advanceable to the heart of the subject; (2) a prosthetic valve support, configured to support a prosthetic valve at a native valve of the heart, and including an upstream support portion, the upstream support portion: (A) having a working configuration in which it is generally annular and (B) having a delivery configuration in which it defines a channel, and is configured to be disposed within the delivery tube; (3) a tissue anchor, slidable through the channel; and (4) an anchor driver. The anchor driver is slidable within the delivery tube and the channel, and configured to anchor the upstream support portion to tissue of the heart by driving the tissue anchor through the upstream support portion and into the tissue, while at least part of the upstream support portion is disposed within the delivery tube.

Abstract: Apparatus for regulating blood flow of a subject is provided, the apparatus comprising a prosthetic valve (20) that comprises a tubular element (22), shaped to define a lumen (23) therethrough, and a valve member (24), configured to be coupled to the tubular element (22) and to be disposed within the lumen (23). The prosthetic valve (20) has (1) a compressed configuration in which the lumen (23) has a compressed width, the valve member (24) is generally cylindrical, and the prosthetic valve (20) is configured to be percutaneously delivered into the subject, and (2) an expanded configuration in which the lumen (23) has an expanded width that is greater than the compressed width, and the valve member (24) is generally disc-shaped, is coupled to the tubular element (22), and is disposed within the lumen (23). Other embodiments are also described.

Abstract: Apparatus is provided for use with a prosthetic valve for implantation at a native valve of a subject, the native valve including at least one native leaflet, the apparatus including (1) a prosthetic valve support, including (a) an upstream support portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening that is configured to receive the prosthetic valve, and (b) at least one clip (i) comprising at least two clip arms and a clip-controller interface, the clip-controller interface being coupled to at least one of the clip arms, and (ii) being configured to be coupled to a native leaflet of the native valve; and (2) at least one clip controller, reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip. Other embodiments are also described.