Abstract: The present disclosure relates to delivery assemblies that include a steerable delivery catheter. In an example, the steerable delivery catheter comprises a slotted tube disposed around a primary lumen thereof, the slotted tube comprising a plurality of slots axially spaced from each other, wherein each slot defines a slot circumferential center between circumferential ends thereof. The steerable delivery catheter further comprises a pull-wire lumen extending along at least a portion of the steerable delivery catheter, through which a pull-wire extends, wherein the pull-wire is attached to the slotted tube. The circumferential center of each slot is circumferentially offset from the circumferential center of an adjacent slot by a helix angle.

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: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: A prosthetic heart valve can include a frame, a valve component, a sealing member, and a retaining member. The frame can be radially compressible and expandable between a radially-compressed configuration and a radially-expanded configuration. The valve component can be disposed within and coupled to the frame and have a plurality of leaflets. The sealing member can have a plurality of ribs and a plurality of connectors. The ribs can be coupled to and extend radially outwardly from the frame when the frame is in the radially-expanded configuration. The connectors can be coupled to and extend radially between the frame and the ribs. The sealing member can be configured to reduce or prevent perivalvular leakage around the prosthetic heart valve. The retaining member can be coupled to the frame and the sealing member and can retain the sealing member at a desired spacing relative to the frame.

Abstract: The present disclosure relates to devices designed to aid in accurate positioning and deployment of prosthetic valves inside a native annulus. In an example, a delivery assembly comprises a prosthetic valve comprising a frame movable between radially compressed and expanded configurations, and a delivery apparatus. The delivery apparatus includes an outer delivery shaft, and at least one elongated positioning member extending through, and axially movable relative to, the outer delivery shaft. The elongated positioning member is configured to position a distal end thereof radially outward to the prosthetic valve and axially distal to an outflow end of the frame. In some examples, the delivery apparatus can further include at least one sensor attached to the elongated positioning member.

Abstract: The present disclosure relates to devices designed to aid in accurate positioning and deployment of prosthetic valves inside a native annulus. In an example, a delivery assembly comprises a prosthetic valve comprising a frame movable between radially compressed and expanded configurations, and a delivery apparatus. The delivery apparatus includes an outer delivery shaft, and at least one elongated positioning member extending through, and axially movable relative to, the outer delivery shaft. The elongated positioning member is configured to position a distal end thereof radially outward to the prosthetic valve and axially distal to an outflow end of the frame. In some examples, the delivery apparatus can further include at least one sensor attached to the elongated positioning member.

Abstract: A prosthetic heart valves including an annular frame and one or more detachable outer skirts and methods associated therewith are disclosed. The frame includes a plurality of interconnected struts and one or more outer skirts releasably attached to an exterior surface of the frame. In some examples, an outer skirt is attached to the frame via at least one retaining suture formed by a plurality of stitches looped around a pull suture. Removal of the pull suture from the suture line enables the outer skirt and frame to separate as the stitches are pulled through openings in the outer skirt and remain attached to the frame. Removability of the outer skirt can facilitate improvements in implant and explant procedures of the prosthetic valves, such as, for example, valve-in-valve procedures.

Abstract: A balloon catheter can comprise a shaft and a balloon coupled to a distal end portion of the shaft. The balloon can comprise a main body having first and second end portions and a sleeve. The sleeve can comprise a first end portion extending partially over the first end portion of the balloon and a second end portion extending partially over an adjacent surface of the balloon catheter. The first end portion of the sleeve can comprise a first plurality of circumferentially spaced, axially extending fingers. The second end portion of the sleeve can comprise an intermediate portion and a second plurality of fingers extending in a direction opposite the first plurality of fingers.

Abstract: A folding device for an introducer sheath is disclosed herein. The folding device includes a housing including a plurality of jaws rotatably coupled to the housing, each of the plurality of jaws is rotatable within a corresponding channel extending through a side wall of the housing. Each of the plurality of jaws are rotatable between a first (retracted) position, where the plurality of jaws do not extend into a central opening of the housing, and a second (contracted) position where at least a portion of each of the plurality of jaws extends into the central opening of the housing in a configuration to fold and/or compress a portion of the sheath received within the central opening of the housing.

Abstract: A system for crimping a prosthetic valve can include a radially compressible collet positioned around the prosthetic valve, a housing positioned around the collet, and a pusher at least partially disposed within the housing. The collet can include a first axial end portion, a second axial end portion, and an intermediate portion therebetween. The first axial end portion can have an outer diameter adjacent the intermediate portion that is greater than an outer diameter of the intermediate portion. The second axial end portion can have an outer diameter adjacent the intermediate portion that is greater than the outer diameter of the intermediate portion. The housing can include a housing internal annular ledge configured to slidably engage the second axial end portion of the collet. The pusher can include a pusher internal annular ledge configured to slidably engage the first axial end portion of the collet.

Abstract: A prosthetic heart valve includes an annular frame, leaflets, each leaflet having opposing commissure tabs, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, and post members mounted on an interior surface of the frame, where each post member includes an inner side comprising a commissure receiving portion. The commissure comprises a commissure attachment assembly, which comprises a support member disposed around the paired commissure tabs and at least one wire attached to the support member and extending outward from an outer side of the support member. The commissure attachment assembly is secured to a first post member via the at least one wire such that the outer side of the support member is positioned against the commissure receiving portion and the at least one wire is bent around and tightened against the outer side of the first post member.

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.

Abstract: A cardiac implant comprises a first fluid transfer device configured for placement at least partially within a blood vessel of a heart, a second fluid transfer device configured for placement outside the blood vessel, and one or more lines interconnecting the first fluid transfer device and the second fluid transfer device.

Abstract: A perforation device constituted of a guidewire extending from a proximal portion to a distal portion thereof, wherein the distal portion of the guidewire comprises a first section, the first section comprising an electrically conductive surface, and wherein the distal portion of the guidewire comprises a non-straight shape in a free state thereof.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A prosthetic heart valve includes a valve structure and a frame. The valve structure includes a plurality of leaflets, and the leaflets are configured to move from an open configuration to a closed configuration. The valve structure is coupled to the frame. The frame includes an inflow end, an outflow end, a longitudinal axis extending from the inflow end to the outflow end, and a plurality of struts forming a plurality of rows of cells. Each row of cells extends in a circumferential direction perpendicular to the longitudinal axis. Adjacent cells in a row of cell are coupled together at a junction of the struts defining the adjacent cells.

Abstract: A device for crimping a radially expandable and collapsible prosthetic valve comprises a crimping loop having a first end portion, a second end portion, and a loop portion extending between the first and second end portions and defining an opening configured to receive the prosthetic valve. The crimping loop is movable between a first state in which the opening has a first diameter and a second state in which the opening has a second diameter smaller than the first diameter such that when the prosthetic valve is positioned within the loop portion, movement of the crimping loop from the first state to the second state is effective to reduce a diameter of the prosthetic valve. A method for crimping a prosthetic valve comprises reducing a diameter of an opening of a crimping loop, thereby radially compressing an at least partially expanded prosthetic valve disposed within the opening.

Abstract: An implantable device or implant is configured to be positioned within anatomy such as a native heart valve to repair the valve. The implantable device or implant is configured to be attached to one or more portions of the anatomy or native heart valve, such as one or more portions thereof can be moved closer together. For example, native valve leaflets, chordae tendinea, papillary muscles, a leaflet cleft, etc. can be moved to prevent or inhibit regurgitant flow through the native valve.

Abstract: Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

Abstract: A prosthetic heart valve includes an annular frame that is radially collapsible and radially expandable, a plurality of leaflets situated within the frame, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure, and a plurality of post members mounted on an interior surface of the frame. The at least one commissure includes a commissure attachment assembly including a support member disposed at least partially around the commissure tab portions and the commissure tab portions are folded around the support member. The commissure attachment assembly is secured to a first post member of the plurality of post members such that the commissure tab portions are positioned between the first post member and the support member.

Abstract: A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.