Abstract: A method includes delivering an implant to a heart of a patient using a delivery tool that includes a nosepiece that is fixed to a shaft and distal to an implant, and an expandable element proximal to the nosepiece. Maximally-expanded, the expandable element (i) has an expanded external diameter at its widest part that is smaller than the expanded internal diameter of a lumen of the frame of the implant and (ii) tapers proximally away from the widest part and from the nosepiece. In a compressed state of the implant a portion of the expandable element is disposed within the lumen of the frame. The method includes, following implantation of the implant, withdrawing the expandable element proximally through the lumen of the implant, between leaflets of the implant, and out of the lumen. Other applications are also described.

Abstract: A prosthetic heart valve includes a first frame shaped having metal segments and defines a lumen therethrough. A leaflet frame is coupled to and disposed within the lumen of the first frame. A second frame is configured to be placed against an upstream surface of the native valve. A plurality of prosthetic leaflets are coupled to the leaflet frame and facilitate upstream-to-downstream bloodflow through the prosthetic valve. Fabric couples the first and second frames together in the collapsed and expanded states of the prosthetic valve. In the expanded state of the prosthetic valve, the fabric separates a downstream end of the second frame and an upstream end of the metal segments of the first frame in a manner in which a gap is defined between the first and second frames, with no metallic structure being disposed within the gap. 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: First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. Other embodiments are also described.

Abstract: An expandable prosthetic valve for implantation within a heart valve includes an expandable valve body having upstream and downstream ends and an intermediate portion. The valve body includes an outer frame including a plurality of outer frame struts intersecting at junctions of the outer frame struts, and an inner frame situated at least partially within the outer frame and comprising a plurality of inner frame struts intersecting at junctions of the inner frame struts. The prosthetic valve includes a plurality of tissue anchoring legs. Each leg extends from a junction of the outer frame struts that is within the intermediate portion of the valve body. A connector pin is at an intersection of one of the tissue anchoring legs and two outer frame struts that are adjacent to the tissue anchoring leg, and connects the inner and outer frames. Other embodiments are also described.

Abstract: Apparatus is provided for use at a calcified native valve of a patient's heart, the apparatus including a prosthetic valve (22, 62, or 66) deliverable to the heart through a catheter. The prosthetic valve includes a frame (24) that includes: (i) a valve body (26) that circumscribes a central longitudinal axis of the prosthetic valve and defines a lumen along the axis; and (ii) arms (28) that are attached to and extend from respective circumferential sites of the valve body in an upstream direction. Each of the arms extends radially outward to a respective arm-tip (29) in an expanded state of the frame. Prosthetic leaflets (55) are disposed within the lumen and facilitate one-way fluid flow through the lumen following implantation of the prosthetic valve in the heart. A shape-conforming element (40) surrounds the valve body and conforms to calcified areas of cardiac tissue. Other embodiments are also described.

Abstract: A percutaneous delivery tool includes a shaft, and proximal and distal capsules which move axially with respect to the shaft. A prosthetic valve includes a tubular portion, an upstream support portion extending therefrom and a plurality of flanges each having a respective flange end-portion. The prosthetic valve is restrainable by the delivery tool, such that the shaft and a downstream end of the tubular portion are disposed within the distal capsule, and the upstream support portion and the flange end-portions are disposed within the proximal capsule. Other embodiments are also described.

Abstract: An implant for implantation at a native atrioventricular valve of a subject, includes a frame assembly, including a valve frame and an outer frame coupled to each other. The valve frame includes a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, and an upstream support portion including a plurality of arms. Each arm extends radially outward from the tubular portion to engage tissue in the atrium. The outer frame includes a ring that circumscribes the tubular portion, and a plurality of ventricular anchors that extend radially outward from the ring and are configured to anchor the implant to tissue of the ventricle. In an expanded state of the frame assembly, the implant defines a toroidal space between the plurality of ventricular anchors and the upstream support portion. Other embodiments are also described.

Abstract: First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. 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: A delivery tool including a shaft and a proximal capsule and a distal capsule is dimensioned for percutaneous delivery to the heart. An open end of the proximal capsule faces the open end of the distal capsule. The capsules are coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft. A prosthetic heart valve includes a tubular portion that defines a lumen and prosthetic leaflets disposed within the lumen. The prosthetic heart valve is restrainable in a compressed state by the delivery tool, such that a downstream end of the tubular portion is disposed within the distal capsule. The distal capsule is shaped so as to define an opening for visualizing ensheathing of at least a portion of the downstream end of the tubular portion within the distal capsule. Other embodiments are also described.

Abstract: A method, for use at a mitral valve of a heart of a subject, is provided which includes advancing a transluminal sheath into a femoral vein of the subject, through an inferior vena cava of the subject, into a right atrium of the subject, and transseptally into a left atrium of the subject. A surrounding-sheath is advanced out of a distal end of the transluminal sheath, into the left atrium, and toward a commissure of the mitral valve. An anchor is implanted by advancing the anchor out of the surrounding-sheath into a left ventricle of the subject, such that the anchor helically wraps around left ventricular mitral valve tissue. The surrounding-sheath is then extracted from the heart and then, a guide wire is advanced through the transluminal sheath. Other embodiments are also described.

Abstract: Apparatus is provided, including a frame assembly that includes a valve body that circumscribes a longitudinal axis and defines a lumen along the axis. A plurality of prosthetic leaflets are disposed within the lumen, and are arranged to facilitate one-way upstream-to-downstream fluid flow through the lumen. A flexible pouch defines an interior space therein. The pouch is shaped and is coupled to the frame assembly such that the pouch circumscribes the valve body, and has (1) a narrowed portion, (2) an inner portion of the interior space, radially inward from the narrowed portion, and in fluid communication with the lumen, and (3) an outer portion of the interior space, radially outward from the narrowed portion, and in fluid communication with the inner portion via the narrowed portion. Other embodiments are also described.

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: Apparatus and methods are described including a prosthetic atrioventricular valve (10) for coupling to a native atrioventricular valve (12). The prosthetic valve includes a support frame (20) and a covering (22), which at least partially covers the support frame. The support frame and the covering are shaped so as to define a downstream skirt (24). A plurality of prosthetic leaflets (40) are coupled to at least one element selected from the group consisting of: the support frame and the covering. An elongated anchoring member (152) is positioned around the downstream skirt in a subvalvular space (150), such that the anchoring member presses native leaflets (30) of the native valve against the downstream skirt, thereby anchoring the prosthetic valve to the native valve. Other applications 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 method includes delivering an implant to a heart of a patient using a delivery tool that includes a nosepiece that is fixed to a shaft and distal to an implant, and an expandable element proximal to the nosepiece. Maximally-expanded, the expandable element (i) has an expanded external diameter at its widest part that is smaller than the expanded internal diameter of a lumen of the frame of the implant and (ii) tapers proximally away from the widest part and from the nosepiece. In a compressed state of the implant a portion of the expandable element is disposed within the lumen of the frame. The method includes, following implantation of the implant, withdrawing the expandable element proximally through the lumen of the implant, between leaflets of the implant, and out of the lumen. Other applications are also described.

Abstract: An implant includes a support frame, having a compressed state, and an expanded state in which the support frame defines an opening therethrough, and is dimensioned to be placed against an upstream surface of a native heart valve. The implant includes a valve frame having a compressed state, and an expanded state in which the valve frame defines a lumen therethrough, and including a valve member disposed within the lumen. The valve frame is coupled to the support frame via a flexible sheet such that when the support and valve frames are in their expanded state, the valve frame is not in contact with the support frame. The implant is housed in the catheter for implanting transfemorally, with the valve frame closer to a distal end of the catheter than the support frame is to the distal end of the catheter. Other embodiments are also described.

Abstract: An implant includes a central body and anchoring arms that extend proximally from the implant's downstream end portion and that are movable with respect to an upstream end portion of the implant. The implant is advanced into the heart using a catheter and is implanted at a native atrioventricular valve by positioning: (i) the anchoring arms in the ventricle, (ii) the central body between the native valve's leaflets, and (iii) a distal end of an elongate element into the ventricle. The elongate element is (1) pulled to apply a proximally-directed force to the anchoring arms to move the anchoring arms' distal ends axially with respect to the upstream end portion while the distal ends of the anchoring arms remain radially fixed with respect to a central longitudinal axis of the implant, and (2) removed from the subject's body. Other embodiments are also described.

Abstract: Embodiments of the present disclosure include a method for conditioning ex vivo pericardial tissue that has a parietal side and a fibrous side from which fibers extend. A blade assembly includes a blade head having a blade array and a face that defines gaps therein. The parietal side of the tissue is placed downward against a support plate, and a motor is operated to move the blade array with respect to the face. The face contacts the tissue such that the fibers protrude through the gaps and into the blade head. The blade array shears the fibers that protrude through the gaps into the blade head, yielding sheared fibers. Other embodiments are also described.