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.

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: 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 device may include a frame including an inflow end and an outflow end. The frame defines a lumen between the inflow end and the outflow end. A device may include a first expandable member coupled to at least one portion of an internal surface of the frame and including a first inflation port. The first expandable member defines a first volume configured to receive an inflation fluid therein through the first inflation port. The first expandable member is configured to be reversibly inflatable to a first plurality of inflation states to partially or fully occlude the lumen. The devices described herein may be used to alleviate symptoms from congestive heart failure or chronic kidney disease.

Abstract: The present disclosure relates prosthetic valves and assemblies that include an outer skirt releasably coupled to the frame or to another skirt of the prosthetic valve. In an example, a prosthetic valve assembly includes a prosthetic valve comprising an annular frame and a first skirt attached to the frame, and a second skirt disposed radially outward to the first skirt and releasable coupled to the first skirt via at least one retaining suture attached to the frame and extending through inflow and outflow loops of the first and second skirts. The second skirt is configured to be released from the first skirt upon withdrawal of the at least one retaining suture from the inflow and outflow loops of both skirts.

Abstract: Disclosed herein are prosthetic valves with outer skirts that include patterned threads extending over base layers thereof to provide PVL sealing functionality, and methods for forming such patterned outer skirts. As one example, a prosthetic valve can include an annular frame and an outer skirt disposed around the frame, wherein the outer skirt comprises a base layer, a multi-yarn thread comprising a plurality of multi-filament yarns, and a backing thread. The multi-yarn thread can be embroidered to the base layer and define outer portions extending over an outer surface of the base layer, while the backing layer extends over an inner surface of the base layer, and is wound over the multi-yarn thread at stitch points defined at ends of the outer portions.

Abstract: A prosthetic heart valve includes a frame having an inflow end and an outflow end, and defining a longitudinal axis. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering includes a first woven portion extending circumferentially around the frame and including a plurality of texturized strands or yarns extending along the longitudinal axis of the frame. The covering further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. The texturized strands extend along the longitudinal axis of the frame from the first woven portion to the second woven portion and form a floating portion between the first woven portion and the second woven portion.

Abstract: Prosthetic heart valves and methods for assembling prosthetic heart valves are disclosed. As one example, a prosthetic heart valve includes a frame, commissure support elements, and leaflets, each leaflet comprising a body and opposing commissure tabs, each commissure tab folded over from a corresponding body to form a bend between the commissure tab and body and arranged adjacent to another folded commissure tab of an adjacent leaflet to form a pair of commissure tabs that is coupled to one commissure support element to form a commissure. Each commissure tab is secured to the commissure support element via a reinforcement member positioned against the commissure tab, adjacent to the bend, and secured to and/or at least partially wrapped around the commissure tab and the commissure support element, the reinforcement member comprising a flexible body and a more rigid, central portion, the central portion positioned along a height of the commissure tab.