Abstract: A frame assembly (222) includes a tubular portion (32) that defines a lumen along an axis; a plurality of arms (46) coupled to the tubular portion at a first axial level, each of the arms extending radially outward from the tubular portion to a respective arm-tip; and a plurality of ventricular legs (50) that are coupled to the tubular portion at a second axial level, and that extend radially outward from the tubular portion. A first sheet (440) has a greater perimeter (446), and a smaller perimeter (448) that defines an opening. The first sheet is stitched onto the plurality of arms, with the opening aligned with the lumen. Subsequently, an outer perimeter (454) of a second sheet (450) is stitched to the greater perimeter of the first sheet. Subsequently, the second sheet is everted by passing an inner perimeter (452) of the second sheet around the arm-tips.

Abstract: Prosthetic valves and methods of using prosthetic valves may be provided. 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, such that at least one atrial anchoring arm extends in a first upstream direction from the annular valve body, and a deployed configuration, in which they may deflect radially outward. In the deployed configuration, a first arm portion may be configured to deflect radially outward to extend in a downstream direction, and a second arm portion may be configured to deflect radially outward to extend in a second upstream direction, the first upstream direction being angled relative to the second upstream direction.

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 outer frame, an inner frame, and at least one connector configured to secure the outer frame to the inner frame. The connector may be spaced apart from at least one of the downstream end of the outer frame or the downstream end of the inner frame. The prosthetic heart valve may be configured to maintain a greater distance between the downstream ends of the outer and inner frames when the prosthetic heart valve is radially compressed than when the prosthetic heart valve is radially expanded.

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, 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 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. Commissural portions of prosthetic leaflets are sandwiched between inner layers of the first and second tabs. The tabs protrude from a first side of the panel, and are shaped such that progressively downstream parts of each tab protrude progressively further away from the panel portion. Other embodiments are also described.

Abstract: Embodiments of the present disclosure provide an apparatus comprising a delivery tool and a prosthetic valve, the prosthetic valve comprising a first frame, and a second frame coupled to the first frame. The delivery tool comprises a first catheter, a second catheter, and a rod. A steerable portion of the second catheter extends out of the first catheter, and a steerable distal portion of the rod extends out of the second catheter. An extracorporeal rod-controller is operably coupled to the rod such that operating the extracorporeal rod-controller steers the steerable distal portion of the rod. In a delivery state of the apparatus, the prosthetic valve is compressed onto the rod, distal to the distal end of the second catheter, and the apparatus is transfemorally and transseptally advanceable into a left atrium of a heart of a subject. Other embodiments 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 outer frame, an inner frame, and at least one connector configured to secure the outer frame to the inner frame. The connector may be spaced apart from at least one of the downstream end of the outer frame or the downstream end of the inner frame. The prosthetic heart valve may be configured to maintain a greater distance between the downstream ends of the outer and inner frames when the prosthetic heart valve is radially compressed than when the prosthetic heart valve is radially expanded.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an annular valve body having atrial anchoring arms and ventricular anchoring legs extending therefrom. The atrial anchoring arms and the ventricular anchoring legs may be configured for independent outward radial deflection. In some embodiments, at least one atrial anchoring arm may include first and third arm segments configured to extend in upstream directions and a second arm segment configured to extend in a downstream direction, the second arm segment situated between the first and third arm segments. The terminal end of the at least one atrial anchoring arm may be configured to be situated upstream from the rest of the arm when the prosthetic valve is radially-expanded.

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: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of releasing a prosthetic valve from a delivery capsule within a heart may be provided. The delivery capsule may include a distal capsule portion and a proximal capsule portion. The method may include moving the distal capsule portion in a first direction to release ventricular anchoring legs of the prosthetic valve from the delivery capsule and moving the released legs into contact with a native mitral valve. The method may include moving the proximal capsule portion in a second direction to release atrial anchoring arms of the prosthetic valve from the delivery capsule, after contacting the mitral valve with the released legs. The method may include moving the distal capsule portion in the first direction to release an annular valve body of the prosthetic valve from the delivery capsule.

Abstract: A prosthetic valve includes a tubular valve body, snares, and an upstream support. A native valve of a heart of a subject is disposed between an atrium and a ventricle of the heart, and has an annulus and leaflets. The prosthetic valve is advanced to the heart while in a compressed state. The prosthetic valve is positioned within the heart such that the snares are disposed upstream of the annulus and leaflets. The snares are expanded radially outwardly upstream of the leaflets. Subsequently, the prosthetic valve is moved in a downstream direction such that the snares become disposed downstream of the leaflets. While the snares remain downstream of the leaflets, the upstream support is expanded within the atrium, and the upstream support is placed against an upstream surface of the annulus. Other embodiments are also described.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of implanting a prosthetic valve within a native heart valve may be provided. The method may include delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration. The method may also include unconstraining ventricular tissue anchors and atrial tissue anchors of the prosthetic valve while maintaining an annular valve body of the prosthetic valve in the delivery configuration. The method may also include unconstraining the annular valve body from the delivery configuration while the unconstrained atrial tissue anchors and ventricular tissue anchors are positioned within an atrium and a ventricle, respectively. Unconstraining the annular valve body may decrease a longitudinal distance between the ventricular tissue anchors and atrial tissue anchors to secure the prosthetic valve within the native heart valve.

Abstract: A valve frame is shaped to define a plurality of atrial arms, and a tubular portion that defines a lumen along a longitudinal axis of the valve frame. Prosthetic leaflets within the lumen are coupled to the frame. An outer frame defines a ring and a plurality of ventricular legs coupled to the ring. The ring circumscribes the tubular portion, and is defined by a pattern of alternating peaks and troughs. The tubular portion defines a row of upstream cells, and a row of downstream cells that is tessellated with the row of upstream cells. Each of the atrial arms is attached to, and extends from, a respective connection site at which adjacent upstream cells are connected to each other. Other embodiments are also described.

Abstract: Apparatus and methods are provided including a mitral valve prosthesis. The prosthesis includes an inner support structure having downstream and upstream sections, the upstream section having a cross-sectional area greater than the downstream section. The inner support structure is configured to be positioned on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into the left ventricle. A prosthetic valve having prosthetic valve leaflets is coupled to the inner support structure. An outer support structure has engagement arms, downstream ends of the engagement arms being coupled to the inner support structure. The prosthesis is configured such that, upon implantation thereof: downstream ends of the native valve leaflets, downstream ends of the engagement arms, and downstream ends of the prosthetic leaflets, are disposed at a longitudinal distance from one another of less than 3 mm. Other embodiments are also described.

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 method is provided, comprising: (1) making a transapical puncture into a left ventricle of the heart; (2) making a transseptal fenestration in the heart; (3) delivering a prosthetic valve via the transapical puncture and implanting the prosthetic valve at a mitral valve of the heart; and (4) subsequently to delivering the prosthetic valve and making the transseptal fenestration, closing the transapical puncture. Other embodiments are also described.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, an expandable prosthetic valve may be configured for implantation within a native heart valve. The prosthetic valve may include an expandable outer frame formed at least partially of outer frame struts. The prosthetic valve may also include an inner frame with tissue anchors extending therefrom, the inner frame being formed at least partially of inner frame struts. The struts along the downstream ends of the outer and inner frames may be arranged in undulating configurations to extend between peaks and troughs. A trough of the outer frame may be configured to be situated downstream from a peak of the inner frame.

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.