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.

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 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 arranged in a cellular structure defined by first and second circumferential rows 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. The struts are joined at four corners of the four-side closed cell. Each of the four sides of each of the four-sided closed cells is double-strutted. Other embodiments are also described.

Abstract: A delivery tool 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, (ii) tapers proximally away from the widest part and from the nosepiece, and (iii) is dimensioned to slide proximally through the lumen of the implant in its expanded state, between leaflets of the implant, and out of the lumen. When non-expanded, the widest part of the expandable element has a non-expanded external diameter that is smaller than the expanded external diameter of the expandable element. In a compressed state of the implant a portion of the expandable element is disposed within the lumen of the frame. Other applications are also described.

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: 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 prosthetic heart valve configured for transcatheter implantation is provided, the prosthetic heart valve including a prosthetic valve frame and a plurality of prosthetic leaflets and arranged to facilitate one-way inflow-to-outflow fluid flow in a proximal-to-distal direction when the prosthetic heart valve is in an expanded state. The prosthetic valve frame includes a plurality of struts, and is shaped so as to define a plurality of intermediate nodes that are intermediate proximal and distal ends of the prosthetic valve frame. A portion of the plurality of struts are intermediate struts. Each intermediate node has at least four struts extending therefrom, the at least four struts including (a) a distally-extending pair of two struts the at least four struts, and (b) a proximally-extending pair of two struts of the at least four struts. 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. The prosthetic valve may also include a plurality of tissue anchors arranged about the valve body and configured to extend from connection points on the valve body. The prosthetic valve may also include at least one protective fabric covering extending over each of the connection points between each tissue anchor and the valve body.

Abstract: A prosthetic aortic valve is provided including a frame including interconnected stent struts arranged so as to define interconnected stent cells. A plurality of prosthetic leaflets are coupled to the frame so as to allow blood flow in a downstream direction and inhibit blood flow in an upstream direction when the prosthetic aortic valve is in an expanded deployment configuration. Circuitry is mechanically coupled to the frame. An electrode is mechanically coupled to the frame. A printed circuit board (PCB) is shaped so as to define an elongate portion. An electrical lead electrically couples the electrode to the circuitry, and is integral with the elongate portion of the PCB. The elongate portion of the PCB is mechanically coupled to some of the interconnected stent struts of the frame. Other embodiments are also described.

Abstract: A prosthetic aortic valve is provided including a frame including interconnected stent struts arranged so as to define interconnected stent cells. Upstream ones of the stent cells are located in an upstream half of the frame and define respective upstream peaks. An electrode is disposed at or near an upstream peak of one of the upstream stent cells. First and Second upstream stent struts of the one of the upstream stent cells are joined at the upstream peak. Coupling material is shaped so as to define a first strip that is mechanically coupled to the first upstream stent strut, a second strip that is mechanically coupled to the second upstream stent strut, and a junction, which couples together the first and the second strips, such that the first and the second strips together couple the electrode to the frame at or near the upstream peak. 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 closure device (320) is provided for suturing a puncture. The closure device (320) includes a suture (322, 822), an elongate support (328), a suture-positioning support (330), and an elongate dilator (344). The suture-positioning support (330) is coupled to a distal end portion (332) of the elongate support (328), laterally extendable with respect to the distal end portion (332) of the elongate support (328), and configured to removably receive the suture (322, 822). The dilator (344) is configured to be inserted through the puncture, and has a proximal end (348) that is coupled to the distal end portion (332) of the elongate support (328). The closure device (320) is configured to allow movement of the distal end portion (332) of the elongate support (328) with respect to the proximal end (348) of the dilator (344) with at least two degrees of freedom. Other embodiments are also described.

Abstract: A method for grouping prosthetic valve leaflets of an aggregate of prosthetic valve leaflets is provided. Using a computer processor, for each leaflet of the aggregate, a leaflet-flexibility value is derived. A group size value is provided to the processor. Using the processor, at least some of the leaflets of the aggregate are designated into leaflet groups, based on similarity between the respective leaflet-flexibility value of each leaflet of the aggregate. Each of the leaflet groups includes a number of leaflets equal to the group size value. Using the processor, an indication of the designated leaflet groups is outputted. 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: 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: 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: 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.