Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body, a plurality of atrial anchoring arms configured to extend radially outward from the valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the valve body. The prosthetic valve may also include a blood-inflatable cuff situated between the arms and legs. The cuff may be configured to substantially fill a volume between the arms and the legs when the cuff is fully inflated with blood.

Abstract: Apparatus is provided, comprising a ring, comprising a plurality of struts arranged in a pattern of alternating peaks and troughs, each strut having a first end-portion and a second end-portion, each peak defined by convergence of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of adjacent second end-portions. The apparatus also comprises a plurality of anchors. Each anchor has a longitudinal axis, is configured to be driven along the longitudinal axis into tissue of the heart, and is coupled to the ring at a respective trough in a manner that facilitates (i) movement of the anchor along the longitudinal axis with respect to the trough, and (ii) deflection of the longitudinal axis with respect to the trough.

Abstract: An anchor includes (a) an anchor head; and (b) a tissue-engaging member extending distally away from the anchor head until a distal tip of the tissue-engaging member, and configured to anchor the anchor to tissue. An anchor driver can include (a) a longitudinal shaft, having a flexible distal portion and a distal end; (b) a deployment element at the distal end of the shaft, reversibly lockable to the anchor head, and reversibly movable between (i) a locked state that retains locking between the deployment element and the anchor head, and (ii) an unlocked state that unlocks the deployment element from the anchor head; and (c) a tissue-piercing lance, reversibly movable between (i) an extended state in which the lance extends distally from the shaft past the distal tip of the anchor, and retains the deployment element in the locked state, and (ii) a retracted state in which the deployment element automatically moves into the unlocked state.

Abstract: Heart valve prostheses are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame including a first portion and a second portion. In the collapsed configuration, the first portion is positioned adjacent to the second portion. In the expanded configuration, the first portion moves to be positioned within an interior area of the second portion.

Abstract: A tubular valve body has an upstream end and a downstream end, and has a central longitudinal axis, and defines a lumen along the axis. Prosthetic leaflets are disposed within the lumen, and are configured to facilitate one-way movement of fluid through the lumen in an upstream-to-downstream direction. The valve body has a cellular structure defined by a plurality of joists connected at nodes, the joists and nodes delimiting cells of the cellular structure. The nodes include minor nodes at which 2-4 joists are connected, and major nodes at which 6-8 joists are connected. The cells of the cellular structure comprise a first circumferential row of first-row cells. Each of the first-row cells is connected to each of its circumferentially-adjacent first-row cells at a respective one of the major nodes, and is longitudinally delimited by two of the minor nodes. Other embodiments are described.

Abstract: A frame assembly includes a valve body, a plurality of arms that each extend radially outward from the valve body to a respective arm-tip, and a plurality of ventricular legs that are coupled to the valve body and that extend radially outward from the valve body and toward the plurality of arms. A liner lines the lumen. Prosthetic leaflets are attached to the liner within the lumen. A first sheet of flexible material is attached to the plurality of arms. A second sheet of flexible material is attached to the first sheet and extends radially inwards and downstream, and is attached to the valve body. The first sheet, the second sheet, and the liner define an inflatable pouch therebetween. The apparatus defines a plurality of windows from the lumen into the pouch.

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 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 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: A unitary flexible sheet is folded to define: (i) a panel, defining a plane, and having a first side facing in a first direction away from the plane, (ii) a first tab, disposed on the first side of the panel, and protruding in the first direction away from the panel, and (iii) a second tab, disposed on the first side of the panel, and protruding in the first direction away from the panel. Between the first tab and the second tab are secured (i) a first-leaflet commissural portion of a first prosthetic leaflet, and (ii) a second-leaflet commissural portion of a second prosthetic leaflet. At the first tab, the sheet is folded to define a first cushion at a downstream edge of the first tab. At the second tab, the sheet is folded to define a second cushion at a downstream edge of the second tab.

Abstract: Apparatus and methods are provided for use with a mitral valve of a heart of a subject. The apparatus includes a P1-anchor, a P2-anchor, and a P3-anchor, that are anchored to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors. A cardiac-site anchor anchors the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet. Other embodiments are also described.

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: A unitary flexible sheet is folded to define: (i) a panel, defining a plane, and having a first side facing in a first direction away from the plane, (ii) a first tab, disposed on the first side of the panel, and protruding in the first direction away from the panel, and (iii) a second tab, disposed on the first side of the panel, and protruding in the first direction away from the panel. Between the first tab and the second tab are secured (i) a first-leaflet commissural portion of a first prosthetic leaflet, and (ii) a second-leaflet commissural portion of a second prosthetic leaflet. At the first tab, the sheet is folded to define a first cushion at a downstream edge of the first tab. At the second tab, the sheet is folded to define a second cushion at a downstream edge of the second tab.

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: A method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic valve.

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.