Abstract: A leaflet assembly for a prosthetic heart valve is disclosed. As one example, a prosthetic valve can include a leaflet sub-assembly which can include a leaflet including a cusp edge portion and two opposing leaflet tabs, and a skirt including a skirt middle portion and two tabs, where each tab comprises a first and second flaps, the first flap connected to and extending upwardly from an upper end of the skirt middle portion, and the second flap extending away from the first flap such that the second flap is offset from the skirt middle portion. Each tab of the skirt is wrapped around and secured to a corresponding leaflet tab such that the first flap covers a first side of the leaflet tab and the second flap covers a second side of the leaflet tab, thereby forming a half commissure portion at either end of the leaflet sub-assembly.

Abstract: A prosthetic heart valve can include a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between an outflow end and an inflow end of the frame. The plurality of interconnected angled struts can be arranged to form a plurality of circumferentially extending rows of struts, including an outflow row of struts at the outflow end of the frame, one or more intermediate rows of struts, and an inflow row of struts at the inflow end of the frame, the one or more intermediate rows of struts disposed between the outflow row of struts and the inflow row of struts. Each strut of the outflow row of struts can have a width greater than a width of each strut of the one or more intermediate rows of struts.

Abstract: An assembly and associated method for a commissure of a prosthetic heart valve is disclosed. As one example, a method includes forming each of a plurality of commissures with a plurality of leaflets by pairing a first commissure tab of a first leaflet with an adjacent, second commissure tab of a second leaflet, folding a support strip over an inner reinforcing element, positioning the folded support strip between the first and second commissure tabs, and attaching first and second outer reinforcing elements to the first and second commissure tabs, respectively, via stitching, the stitching extending over at least a portion of the first reinforcing element opposite a fold region of the support strip, and, for each commissure, securing end portions of the support strip to a respective support portion of a frame of the prosthetic heart valve.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of angled strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The frame has an inflow end and an outflow end, and includes a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets arranged to form a plurality of commissures. The frame includes a plurality of commissure support elements, each commissure support element being positioned at one of the commissures. Each of the commissure support elements has a coupling portion coupled to the frame and first and second members coupled to the coupling portion and extending in a direction toward the inflow end of the frame or toward the outflow end of the frame. The leaflets of each commissure are received between the first and second members of the respective commissure support element.

Abstract: Barrier layers for a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame having an inflow end and an outflow end, a plurality of leaflets disposed within the annular frame, each leaflet comprising a cusp edge portion that is positioned towards the inflow end of the frame, a skirt coupled to the annular frame, and a barrier layer coupled to each leaflet and comprising a first end and a second end, wherein the first end is coupled to the cusp edge portion and the second end is coupled to the skirt, wherein the barrier layer at least partially extends around the inflow end of the annular frame.

Abstract: A prosthetic valve has a radially expandable and compressible frame including a plurality of interconnected struts and a valvular structure including a plurality of leaflets configured to regulate the flow of blood through the prosthetic valve. The leaflets can have undulating cusp edge portions. The prosthetic valve further includes at least one connecting skirt having a shape that corresponds to the cusp edge portion of at least one leaflet. The connecting skirt can connect the cusp edge portion of the leaflet to at least one of the struts of the frame. The connecting skirt can include a first set of yarns intersecting with a second set of yarns. The first and second sets of yarns can extend at oblique angles relative to a longitudinal axis of the at least one strut.

Abstract: A delivery device for delivering a prosthetic valve to a target implantation site is disclosed. As one example, a delivery device includes a shaft, a distal shoulder mounted to the shaft, and an adjustable, proximal shoulder mounted to the shaft proximal to the distal shoulder. The proximal shoulder includes a first surface flexibly attached to the shaft, a second surface arranged opposite and spaced radially from the first surface, a third surface extending from the first surface toward the second surface at an angle such that a distal end of the second surface is arranged distal to a distal end of the first surface. The proximal shoulder is adjustable from a first position to a second position where the angle is decreased such that the distal end of the second surface is arranged closer to the distal shoulder and closer to the shaft than in the first position.

Abstract: A leaflet assembly for a prosthetic heart valve is disclosed. As one example, a method includes: forming a plurality of leaflet sub-assemblies, each including a leaflet and a skirt and formed by placing the skirt on one side of the leaflet such that the skirt extends along a curved cusp edge portion and two commissure tabs of the leaflet, folding two end portions of the skirt around corresponding commissures tabs, stitching each folded end portion to a corresponding commissure tab to form a respective half commissure portion, and stitching the skirt to the cusp edge portion and forming the leaflet assembly by pairing each half commissure portion of each leaflet sub-assembly with a half commissure portion of another leaflet sub-assembly to form a plurality of pairs of adjacent half commissure portions, and for each pair, stitching the adjacent half commissure portions to each other to form a commissure.

Abstract: A buckle commissure clamp can be used to attach leaflets of a valvular structure to a frame of a prosthetic heart valve. Tabs of adjacent leaflets can be assembled to the buckle commissure clamp by passing each leaflet through one or more gaps of the buckle commissure clamp. Each leaflet tab can be wrapped around portions of the buckle commissure clamp. Once the leaflet tabs are assembled to the buckle commissure clamp, the assembly can be attached to the frame, for example, by one or more sutures extending between the buckle commissure clamp and a support member, such as a strut of the frame, an actuator of the frame, a locking mechanism of the frame. In some embodiments, the buckle commissure clamp has a substantially W-shape or M-shape.

Abstract: Leaflets for prosthetic heart valves are disclosed. As an example, a prosthetic heart valve comprises a frame and a plurality of leaflets mounted on an inside the frame, where each leaflet comprises a main body with a cusp edge portion and an outflow edge portion. Each leaflet is compressed in an X direction and/or Y direction to form a concave shape.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of angled strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The frame has an inflow end and an outflow end, and includes a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets arranged to form a plurality of commissures. The frame includes a plurality of commissure support elements, each commissure support element being positioned at one of the commissures. Each of the commissure support elements has a coupling portion coupled to the frame and first and second members coupled to the coupling portion and extending in a direction toward the inflow end of the frame or toward the outflow end of the frame. The leaflets of each commissure are received between the first and second members of the respective commissure support element.

Abstract: A belt for an implantable prosthetic device can include an annular body including a plurality of alternating peaks and valleys and a plurality of frangible members extending between at least one of adjacent peaks and adjacent valleys. The annular body can be radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via an expandable implantable prosthetic device. A first frangible member of the plurality of frangible members can be configured to break when the radially outwardly directed force exceeds a first predetermined threshold to allow radial expansion of the annular body to a second diameter.

Abstract: An implant is provided for use at a native cardiac valve of a subject. The implant has a central axis and a frame that, in an implanted configuration, defines a circumferential ring of spiked cells around the central axis. Each spiked cell has four corners consisting of an inner apex, two lateral corners connected, at respective intermediate junctions, to lateral corners of adjacent cells, and an outer apex oriented radially away from the central axis. The spiked cells are defined by struts that carry spikes. The intermediate junctions provide circumferential articulation such that each spiked cell bends with respect to adjacent cells to move its outer apex toward and away from the central axis independently of outer apices of the adjacent cells in a manner that maintains the spikes of that cell in tissue-gripping contact with tissue of the valve. Other embodiments are also described.

Abstract: Prosthetic heart valves including a plurality of leaflets coupled to the frame and methods for leaflet attachment. The leaflets are disposed within the frame and configured to regulate the flow of blood through the frame, each leaflet comprising a cusp edge portion having a first central (apex) region and second and third side regions on opposing sides of the first region. The first region is folded and forms an inflow end of the leaflet when coupled to the frame. The side regions are coupled to the frame in an unfolded state. The leaflets can be coupled to the frame via a connecting suture line or an inner skirt.

Abstract: The present disclosure relates to prosthetic valves configured to allow or encourage tissue adherence to polymeric surfaces of valvular structures thereof. In an example, a prosthetic valve can include a frame movable between a radially compressed state and a radially expanded state, and a valvular structure mounted inside the frame, the valvular structure comprising a plurality of leaflets. Each leaflet comprises a leaflet polymeric inner surface facing a central longitudinal axis of the prosthetic valve, and a leaflet polymeric outer surface facing the frame, wherein at least one of the polymeric surfaces of the leaflet comprises a tissue-adherent surface, configured to allow tissue adherence thereto.

Abstract: Disclosed are techniques for construction of prosthetic heart valves, particularly techniques for attachment of scalloped edges of valvular leaflets to struts of mechanical frames using sutures and/or other materials as intermediate coupling members. In some embodiments, the scalloped edges of the leaflets are coupled to the segments of the struts of the frame via suture loops that are oriented transverse to the scalloped edges of the leaflets. In some embodiments, central portions of scallop line segments are attached to the scalloped edges of the leaflets and are not attached to the frame. In some embodiments, strut segments are tapered to limit translation of suture loops. In some embodiments, a cloth strip couples the scalloped edges of the leaflets to frame struts. In some embodiments, the scalloped edge is attached to adjacent segments of intersecting struts via sliding suture loops, where the adjacent segments join at a common pivot joint.

Abstract: A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

Abstract: A prosthetic heart valve and delivery device for delivering the prosthetic heart valve to a target implantation site, which reduce contact between the prosthetic heart valve and a delivery sheath through which the delivery device is advanced to the target implantation site, is disclosed. As one example, a prosthetic heart valve may comprise a frame including a first end with a plurality of apices spaced apart from one another around a circumference of the first end and a cover element covering the plurality of apices. The cover element may include a cushioning element or a bio-resorbable element.

Abstract: Adjustable leaflets for prosthetic heart valves are disclosed. As an example, a leaflet for a prosthetic valve can include a main body with a free, outflow edge and a cusp edge portion, and two tabs disposed on opposite sides of the main body, adjacent to the outflow edge. Each tab can include a tab body extending from the main body of the leaflet and a plurality of projections extending outward from the tab body. The projections of the plurality of projections are spaced apart from one another along the tab body to form a plurality of notches therebetween.

Abstract: An implantable prosthetic device can include a radially expandable and compressible frame including an inflow end portion and an outflow end portion. The frame can include an expansion and locking mechanism comprising a member having a first set of lateral extensions disposed adjacent an outflow end and a second set of lateral extensions axially spaced from the first set, each lateral extension comprising a bore extending into the lateral extension. The frame can further comprise a commissure attachment member having a first set of arms each extending into a respective inner bore of the first set of lateral extensions and a second set of arms each extending into a respective inner bore of the second set of lateral extensions such that the commissure attachment member is restrained from movement relative to the expansion and locking mechanism in the radial and axial directions.