Abstract: During a medical procedure, a transseptal fenestration is made at a septum of the heart and a shunt is implanted into the transseptal fenestration. During the same medical procedure, a transapical puncture is made into a left ventricle of the heart. A prosthetic valve is delivered via the transapical puncture and implanted at a mitral valve of the heart. Subsequently to delivering the prosthetic valve and making the transseptal fenestration, the transapical puncture is closed. Other embodiments are also described.

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 valve frame includes a tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around a longitudinal axis of the valve frame, and a plurality of arms, extending radially outward from an upstream portion of the tubular portion to define an arm span, and configured to engage tissue in the atrium. An outer frame is coupled to the valve frame, and includes a ring circumscribing the tubular portion, and a plurality of flanges that extend radially outward from the ring to define a flange span, and are configured to engage ventricular tissue. Each arm defines a rigid portion and a flexible portion that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion. The majority of the flexible portion is disposed further radially outward than the flange span. Other embodiments are also described.

Abstract: Embodiments of the present disclosure include a method for use at a native valve of a heart of a subject. At a distal portion of a delivery tool, a balloon is coupled to a shaft. The distal portion is advanced to the heart with an implant and the balloon disposed within a capsule. The implant includes a tubular frame and one or more shape-memory flanges. The tubular frame is compressed around the balloon, and the flanges are constrained within a downstream capsule-portion of the capsule. The flanges are exposed from the downstream capsule-portion such that the flanges automatically deflect radially outward. Subsequently, the flanges are pressed against a downstream surface of the native valve by moving the implant in an upstream direction. While the flanges are in contact with the downstream surface, the tubular frame is plastically expanded radially by inflating the balloon. Other embodiments are also described.

Abstract: Apparatus for crimping a frame of an implant includes a crimping assembly having a bath having a floor, and one or more side-walls extending upward from the floor to a side-wall height. A crimping mechanism that defines a crimping aperture is attached to the bath such that the crimping aperture is disposed within the bath below the side-wall height. The crimping mechanism further comprises a handle and is actuatable by moving the handle circumferentially around the crimping mechanism. Actuation of the crimping mechanism transitions the crimping aperture from its open state to its narrowed state. 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: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

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: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment portions and at least three rows of angled struts. The rows include a first row, a second row downstream of the first row, and a third row downstream of the second row. Each row of struts includes angled struts arranged in a zig-zag pattern defining a plurality of crowns. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment portions via sutures extending through apertures in the commissure attachment portions, wherein all of the apertures are located along the length of the frame between a first plane defined by the crowns of the second row of struts and a second plane defined by the crowns of the third row of struts.

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 method includes percutaneously advancing an implant to a native heart valve of a subject, the implant being housed in a compressed state within a delivery tool. Next, the method includes unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant. Subsequently, the longitudinally-proximal portion of the implant is unhoused. Subsequently, the longitudinally-distal portion of the implant is unhoused. By unhousing flanges of the implant, the flanges automatically expand. Upon the flanges expanding, a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction. Other applications are also described.

Abstract: Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular valve body and atrial anchors and ventricular anchors extending from the valve body. An atrial anchor may include a pivoting portion configured to extend in an upstream direction when the prosthetic heart valve is in a delivery configuration and in a downstream direction when the prosthetic heart valve is in a deployed-anchor configuration. A portion of a ventricular anchor may be configured to abut the annular valve body when the prosthetic heart valve is arranged in the delivery configuration.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a prosthetic valve may include an annular outer frame formed of struts intersecting at outer frame junctions, an inner frame situated within the outer frame and formed of struts intersecting at inner frame junctions, and a plurality of tissue anchors extending from the outer frame. The junctions along a downstream end of the outer frame may be spaced apart circumferentially from the junctions along a downstream end of the inner frame. The outer frame may include an anchor support strut extending between a downstream junction of the outer frame and a point of connection between one of the tissue anchors and the outer frame. The anchor support strut may be configured for placement parallel to a longitudinal axis of the prosthetic valve.

Abstract: Embodiments of the present disclosure include apparatus including a percutaneous delivery capsule and prosthetic valve. The prosthetic valve includes a frame assembly that includes a tubular portion, and a plurality of atrial arms that extend away from the tubular portion. A plurality of prosthetic leaflets are attached to the tubular portion, and are disposed within a lumen defined by the tubular portion. When the prosthetic valve is in a compressed state and is housed by the capsule, each of the atrial arms extends, in a serpentine shape, along the capsule and away from the tubular portion. 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 assembly (10) for crimping a frame (56) of an implant (58) comprises a crimping device (20) with a base (22) and a crimping mechanism (24) that defines a crimping aperture (26). A bath (28) having a floor (30), and one or more side-walls (32) extending upward from the floor to a side-wall height defines a receptacle (18) that is shaped to receive a portion of the crimping device. The apparatus has an assembled state in which the portion of the crimping device has been received by the receptacle, the crimping device is held securely by the bath, and the aperture is below the side-wall height. Other embodiments are also described.

Abstract: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment portions and at least three rows of angled struts. The rows include a first row, a second row downstream of the first row, and a third row downstream of the second row. Each row of struts includes angled struts arranged in a zig-zag pattern defining a plurality of crowns. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment portions via sutures extending through apertures in the commissure attachment portions, wherein all of the apertures are located along the length of the frame between a first plane defined by the crowns of the second row of struts and a second plane defined by the crowns of the third row of struts.