Abstract: Apparatus is provided, including: (A) a valve body (204) including a first frame (206) shaped to define a lumen therethrough, and a valve member (205) disposed within the lumen, (B) an upstream support (210), configured to be placed against an upstream surface of a native heart valve, and (C) a flexible sheet (214) that couples the upstream support to the valve body. The valve body has a compressed state in which the first frame has a first diameter, and an expanded state in which the first frame has a second diameter that is greater than the first diameter. The support includes a second frame (212) that has a compressed state, and an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter. Other embodiments are also described.

Abstract: Apparatus is provided for use at a native valve of a heart of a subject. The apparatus includes a delivery tube, transluminally advanceable to the heart; and a prosthetic valve support, configured to support a prosthetic valve at the native valve, and comprising an upstream support portion. The upstream support portion has a working configuration in which it is generally annular and has (1) a tissue-contacting side configured to be placed against an atrial surface of the native valve, and (2) an opposing side, and defines an opening therebetween. The upstream support portion also has a delivery configuration in which the upstream support portion is rolled up to define a channel, and is disposed within the delivery tube. The upstream support portion is configured to be transitioned from the delivery configuration to the working configuration by being exposed from the delivery tube, and unrolled.

Abstract: An implant includes a primary structural element, and two clips coupled to the primary structural element, on opposite lateral sides of the primary structural element from each other, each of the clips having a first clip element and a second clip element. The implant is transluminally advanced to a heart valve of a subject. The implant is coupled to leaflets of the valve (i) by, for each of the clips, closing the clip around a central part of a respective leaflet of the valve by causing deflection between the first clip element and the second clip element, thereby sandwiching the central part of the respective leaflet between the first clip element and the second clip element, and (ii) such that the leaflets form a double orifice configuration, with the primary structural element disposed between the central parts of the leaflets. Other embodiments are also described.

Abstract: An implant includes a clip and a clip-controller interface. The clip is disposed laterally from a central longitudinal axis of the implant, includes first and second arms articulatably coupled to each other, and sandwiches a leaflet of a heart valve between the first and second arms by articulation between the first and second arms, such that the second arm is disposed laterally from the first arm. The clip-controller interface is reversibly coupled to a clip controller of a delivery tool, and includes first and second portions. The first portion is linearly slidable by the clip controller. The second portion is articulatably coupled to the first portion and to the second arm, such that linear sliding of the first portion causes the second portion to (i) articulate with respect to the first portion, and (ii) push the second arm to articulate toward the axis. Other embodiments are also described.

Abstract: A native heart valve includes a first leaflet and a second leaflet. The first and second leaflets are arranged into a double-orifice by using the implant to couple a middle scallop of the first leaflet to a middle scallop of the second leaflet. Using at least one clip controller, each clip is opened by deflecting an arm of the clip away from a midline of the implant, and each clip is closed by deflecting the arm of the clip back toward the midline. The first and second clips are opened and closed independently of each other. Other embodiments are also described.

Abstract: A prosthetic valve structure, for use at a native atrioventricular heart valve, includes a frame, prosthetic leaflets, an upper skirt, and a lower skirt. The frame circumscribes a longitudinal axis of the structure. The leaflets are configured to facilitate upstream-to-downstream bloodflow through the structure. The upper skirt has an upstream perimeter. The lower skirt is downstream of the upper skirt, and has a downstream perimeter. The upper skirt extends away from the lower skirt, in an upstream direction and radially outward toward the upstream perimeter. The lower skirt extends away from the upper skirt, in a downstream direction and radially outward toward the downstream perimeter. A downstream portion of the frame is disposed downstream of at least part of the downstream perimeter of the lower skirt.

Abstract: An apparatus for use with a prosthetic heart valve at a native heart valve comprises an adjustable-lumen prosthetic valve support. In a delivery state, the prosthetic valve support is transluminally deliverable to the heart. The prosthetic valve support is transitionable, within the heart, into an implantation state for implantation at the native valve. In the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter. After the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which the lumen has a second diameter that is greater than the first diameter. In the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen.

Abstract: Apparatus for use at a native atrioventricular valve of a heart of a subject includes a prosthetic valve structure. The prosthetic valve structure comprises a valve ring, a leaflet frame, a plurality of prosthetic leaflets, and an upper skirt. The valve ring circumscribes a longitudinal axis of the prosthetic valve structure. The leaflet frame is disposed within the valve ring. The prosthetic leaflets are coupled to the leaflet frame, and are configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure. The upper skirt includes an annular skirt fabric, and an annular skirt frame coupled to the valve ring by the skirt fabric. The upper skirt extends radially outward and in an upstream direction from the valve ring. The upper skirt is configured to rest against an atrial portion of the native atrioventricular valve. 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 spacer configured for implantation with a native heart valve opening and a central valve section configured for disposal within the annular spacer. The central valve section may include at least one anchoring protrusion configured to anchor the central valve section against axial movement relative to the annular spacer. During deployment, the central valve section may be advanced downstream beyond the implanted annular spacer, and moved upstream until the anchoring protrusion engages the annular spacer.

Abstract: A prosthetic valve comprises a valve body, comprising a tubular frame and a plurality of leaflets; an upstream support, comprising a second frame; and a flexible sheet that couples the upstream support to the valve body. The prosthetic valve is compressible into a delivery tool such that the prosthetic valve is in a compressed state in which the second frame and the tubular frame are arranged in series within the tool, and the valve body has a compressed body-diameter. The prosthetic valve is deployable from the tool such that the prosthetic valve automatically expands into an expanded state. In the expanded state, the second frame defines an inner perimeter, the sheet extends inwardly from the inner perimeter to the valve body, and the prosthetic valve defines a conduit through the upstream support and the valve body. Other embodiments are also described.

Abstract: Apparatus is provided for use with a prosthetic valve for implantation at a patient's native heart valve. The apparatus includes an implant and a tool. The implant includes a plurality of metal segments coupled at a plurality of joints to define a ring having upper joints and lower joints disposed along the ring. The implant also includes a plurality of anchors coupled to the ring at the joints. The tool is couplable to the implant, and is configured to anchor the implant at the native heart valve by rotation of the tool. Other embodiments are also described.

Abstract: A transluminal sheath is advanced into a femoral vein of a subject, through an inferior vena cava of the subject, into a right atrium of a heart of the subject, and transseptally into a left atrium of the heart. A surrounding-sheath is advanced out of a distal end of the transluminal sheath, into the left atrium, and toward a commissure of a mitral valve of the heart. A commissural helix is implanted at the commissure by advancing the commissural helix out of the surrounding-sheath and through the commissure into a left ventricle of the heart, such that the commissural helix wraps around at least some chordae tendineae at the commissure and facilitates sealing of the commissure. Subsequently to the implantation of the commissural helix, the surrounding-sheath is extracted from the heart. Other embodiments are also described.

Abstract: A prosthetic valve structure, in a collapsed state thereof, is transcatheterally advanced toward a native valve of a subject, the native valve including native leaflets, and the prosthetic valve structure including prosthetic leaflets. An annular portion of the prosthetic valve structure is positioned between the native leaflets. Subsequently, the prosthetic valve structure is rotated such that curved anchors of the prosthetic valve structure gather the native chordae tendineae of the heart between the anchors and the annular portion.

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: Apparatus for use at a native atrioventricular valve of a heart of a subject includes a prosthetic valve structure. The prosthetic valve structure comprises a valve ring, a leaflet frame, a plurality of prosthetic leaflets, and an upper skirt. The valve ring circumscribes a longitudinal axis of the prosthetic valve structure. The leaflet frame is disposed within the valve ring. The prosthetic leaflets are coupled to the leaflet frame, and are configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure. The upper skirt includes an annular skirt fabric, and an annular skirt frame coupled to the valve ring by the skirt fabric. The upper skirt extends radially outward and in an upstream direction from the valve ring. The upper skirt is configured to rest against an atrial portion of the native atrioventricular valve. Other embodiments are also described.

Abstract: A transluminal sheath is advanced transfemorally into a left atrium of a heart of the subject. A surrounding-sheath is advanced out of a distal end of the transluminal sheath, into the atrium, and toward a commissure of the mitral valve. A helix is implanted at the mitral valve by advancing the helix out of the surrounding-sheath and through the commissure into a left ventricle of the subject, such that the helix wraps around at least some chordae tendineae of the mitral valve. A prosthetic valve is collapsed into a collapsed state, and subsequently to implanting the helix and collapsing the prosthetic valve, the prosthetic valve is advanced, in its collapsed state, through the transluminal sheath to the mitral valve. The prosthetic valve is implanted in the mitral valve by expanding it such that the helix facilitates anchoring of the prosthetic valve and sealing of the commissure.

Abstract: A prosthetic valve comprises a first frame, defining an arrangement of cells; a second frame, a first protrusion, and a second protrusion. In an expanded state of the valve, the first frame is generally cylindrical and has an expanded width, and the valve defines a lumen having a first end and a second end. In a compressed state of the valve, the first and second frames are both generally cylindrical, and the first frame has a compressed width that is smaller than the expanded width. In the expanded state, the valve provides directional fluid flow through the lumen. The valve defines first and second coupling points, and an axis therebetween, the axis lying on a transverse cross-section of the first frame. The first and second coupling points couple the second frame to the first frame by protruding into respective first and second slots defined by the first frame.

Abstract: An apparatus for use with a prosthetic heart valve at a native heart valve comprises an adjustable-lumen prosthetic valve support. In a delivery state, the prosthetic valve support is transluminally deliverable to the heart. The prosthetic valve support is transitionable, within the heart, into an implantation state for implantation at the native valve. In the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter. After the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which the lumen has a second diameter that is greater than the first diameter. In the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen.

Abstract: Apparatus is provided for use with a native valve of a heart of a subject. The apparatus includes: (1) an annular upstream support portion, comprising an expandable first frame, the upstream support portion configured to be placed against an upstream surface of the native valve; (2) a flexible polyester connector; and (3) an anchoring element, flexibly coupled to the upstream support portion by the connector, and configured to anchor the upstream support portion to the native valve by engaging tissue of the native valve.

Abstract: A prosthetic valve structure, in a collapsed state thereof, is transcatheterally advanced toward a native valve of a subject, the native valve including native leaflets, and the prosthetic valve structure including prosthetic leaflets. An annular portion of the prosthetic valve structure is positioned between the native leaflets. Subsequently, the prosthetic valve structure is rotated such that curved anchors of the prosthetic valve structure gather the native chordae tendineae of the heart between the anchors and the annular portion.