Abstract: A prosthetic valve includes a tubular portion coupled to an upstream support portion, and ventricular legs. The prosthetic valve is transitionable from a compressed state into a partially-expanded state in which (1) a downstream surface of the support portion defines (i) an annular concave region extending radially between a concave-region inner radius and a concave-region outer radius, and (ii) an annular convex region, radially outward from the annular concave region, extending radially between a convex-region inner radius and a convex-region outer radius, and (2) the tip of each leg is disposed radially between the concave-region inner radius and the concave- region outer radius. In a fully-expanded state each leg's tip is disposed radially between the convex-region inner radius and the convex-region outer radius. Other embodiments are also described.

Abstract: A prosthetic heart valve implant is provided including a frame shaped so as to define upstream and downstream openings at upstream and downstream ends of the frame, respectively, when the implant is in an expanded state for implantation at a heart native valve. A sheet is coupled to the frame. When the implant is in the expanded state, the frame is shaped so as to define the following longitudinal portions arranged along a central longitudinal axis of the prosthetic heart valve implant: a substantially cylindrical mid portion having a diameter greater than respective diameters of the upstream and the downstream ends of the frame; an upstream portion, extending upstream and radially inward from the mid portion; and a downstream portion, extending downstream and radially inward from the mid portion. Other embodiments are also described.

Abstract: An expandable prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an expandable annular valve body. The valve body may include an atrial inlet opening and a ventricular outlet opening. The valve body may additionally include a plurality of tissue anchors extending from the valve body. The prosthetic valve may additionally include a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

Abstract: A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts, has an upstream end and a downstream end, and defines a lumen. The valve body is shaped so as to define a circumferential row of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. Exactly two of the four sides of each of the four-sided closed cells are double-strutted. Other embodiments are also described.

Abstract: A unitary flexible sheet (612) is folded to define (i) a panel (608); (ii) a first tab (606a), having a first-tab outer layer and a first-tab inner layer, and protruding away from the panel; and (iii) a second tab (606b), having a second-tab outer layer and a second-tab inner layer, and protruding away from the panel. A commissural portion of a first prosthetic leaflet (58a), and a commissural portion of a second prosthetic leaflet (58b) are disposed between the first-tab inner layer and the second-tab inner layer. A first stitching (632) is stitched through the inner layer of each tab, and the commissural portion of each leaflet. A second stitching (634) is stitched through the outer and inner layers of each tab, and the commissural portion of each leaflet. The first-tab outer layer and the second-tab outer layer cover the first stitching. Other embodiments are also described.

Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body and a plurality of atrial anchoring arms and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. The prosthetic valve may also include a blood-inflatable cuff situated between the arms and legs and fastened to at least one arm. The cuff may be configured to extend radially outward beyond a terminal end of at least one arm when fully inflated with blood.

Abstract: A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts, has an upstream end and a downstream end, and defines a lumen. The valve body is shaped so as to define a circumferential row of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. Each of the four sides of each of the four-sided closed cells is double-strutted. Other embodiments are also described.

Abstract: A unitary flexible sheet is folded to defines a panel, and first and second tabs. Each of the tabs has an inner layer and an outer layer. First and second prosthetic leaflets are coupled to a tubular frame via the sheet. Each of the leaflets has a respective commissural portion. For each of the commissural portions, a first region of the commissural portion is sandwiched between inner layers of the first and second tabs, and a second region of the commissural portion is disposed flat against the panel. Other embodiments are also described.

Abstract: An expandable prosthetic valve is implantable within a native mitral valve by terminal ends of ventricular anchors of the prosthetic valve moving outwardly from a constrained delivery position of the ventricular anchors, while the ventricular anchors are positioned within the atrium. Then, a portion of the expandable prosthetic valve containing the ventricular anchors is advanced through the native mitral valve into the ventricle. Terminal ends of atrial anchors of the prosthetic valve move outwardly relative to a portion of an annular valve body of the prosthetic valve while the atrial anchors are at least partially positioned within the atrium. Next, the annular valve body is radially expanded while the ventricular anchors are in the ventricle and the atrial anchors are in the atrium, thereby anchoring native heart valve tissue between the atrial anchors and ventricular anchors. Other embodiments are also described.

Abstract: A valve body circumscribes a longitudinal axis and defines a lumen along the axis. Upstream arms are coupled to the valve body, and extend radially outward from the valve body to respective arm-tips. Downstream legs are coupled to the valve body, and extend radially outward from the valve body and toward the plurality of arms. A flexible pouch extends radially outward from the valve body. The arms and the legs narrow the pouch therebetween to form a narrowed portion of the pouch, thereby defining, in an interior space of the pouch: (a) an inner portion, radially inward from the narrowed portion, and in fluid communication with the lumen, and (b) an outer portion, radially outward from the narrowed portion, and in fluid communication with the inner portion via the narrowed portion. Other embodiments are also described.

Abstract: An implant includes a prosthetic valve and is transitionable from a compressed to an expanded state. The implant includes a frame assembly including a plurality of struts that collectively define an upstream-frame-assembly-perimeter at an upstream end of the frame assembly and a downstream-frame-assembly-perimeter at a downstream end of the frame assembly. The frame assembly includes a valve frame that defines a lumen, and one or more appendages disposed at and extending in a downstream direction from the downstream-frame-assembly-perimeter. A plurality of prosthetic leaflets are disposed within the valve frame lumen and facilitate one-way upstream-to-downstream fluid flow through the lumen. The implant includes a fabric and, in the expanded state of the implant, the fabric obscures the one or more appendages and defines a downstream perimeter of the fabric at a downstream end of the implant. Additional embodiments are described.

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: An expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an expandable valve body having an atrial end, a ventricular end opposite the atrial end, and an intermediate portion extending between the atrial end and the ventricular end. The valve body may include a plurality of struts intersecting at junctions. The prosthetic valve may also include a plurality of tissue anchoring legs extending from junctions within the intermediate portion of the valve body. At least one of the tissue anchoring legs may have a cross-sectional area which is larger by at least 20% than a cross-sectional area of a strut extending between the at least one tissue anchoring leg and an adjacent tissue anchoring leg.

Abstract: A heart valve delivery system may be provided. The heart valve delivery system may include at least a first catheter movable relative to second and third catheters, arranged in a telescoping configuration. The second catheter may be movable relative to and extend from the distal end of the third catheter. The delivery system may include a first adjustable flexure radius associated with the second catheter, and a second flexure radius. The delivery system may include at one control handle assembly configured to permit the catheters to rotate together, independently adjust the first and second flexure radii, cause relative axial movement between the catheters, and permit the ejector to cause relative movement between a heart valve and a capsule connected to the first catheter.

Abstract: A prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an annular valve body, as well as a plurality of ventricular anchoring legs and a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body. The ventricular anchoring legs and grasping segments of the atrial anchoring arms may be configured to substantially restrict axial movement of the annular valve body within the native heart valve. In addition, anchoring segments of the atrial anchoring arms may be configured for lateral deformation relative to the native heart valve.

Abstract: A prosthetic heart valve, which may include an expandable annular outer frame having a tubular portion and at least one tissue anchor portion configured to extend from the tubular portion, may be provided. The at least one tissue anchor portion may have a plurality of attachment locations. The prosthetic heart valve may also include an expandable inner frame configured at least partially within the expandable annular outer frame. The expandable inner frame may be connected to the expandable annular outer frame solely at one or more of the plurality of attachment locations of the at least one tissue anchor portion.

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 annular valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. The arms may be configured to engage an atrial portion of the native mitral valve and the ventricular anchoring legs may be configured to engage a ventricular portion of the native mitral valve. The atrial anchoring arms and the ventricular anchoring legs may be positioned relative to each other such that when the atrial anchoring arms and ventricular anchoring legs engage the native mitral valve, a volume between the atrial anchoring arms and ventricular anchoring legs is configured to be substantially filled with tissue.

Abstract: A prosthetic valve delivery system may be provided. The prosthetic valve delivery system may include a first catheter and a first steering mechanism configured to bend the first catheter within a first steering plane. The prosthetic valve delivery system may also include a second catheter coaxially arranged within the first catheter and a second steering mechanism configured to bend the second catheter within a second steering plane, different from the first steering plane. Moreover, the prosthetic valve delivery system may include a capsule positioned distal to both the first catheter and the second catheter. The capsule may be configured to retain a prosthetic valve therein during transvascular advancement of the capsule.

Abstract: An expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an expandable valve body having an atrial end, a ventricular end opposite the atrial end, and an intermediate portion extending between the atrial end and the ventricular end. The valve body may include a plurality of struts intersecting at junctions. The prosthetic valve may also include a plurality of tissue anchoring legs extending from junctions within the intermediate portion of the valve body. At least one of the tissue anchoring legs may have a cross-sectional area which is larger by at least 20% than a cross-sectional area of a strut extending between the at least one tissue anchoring leg and an adjacent tissue anchoring leg.

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.