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: An implantable device includes an adjustable spacer and at least one anchor. The adjustable spacer is configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween. The adjustable spacer can comprise a first side and a second side opposite the first side. Each side can be adjustable between a first width and a second width. Each side can be independently moved between the first width and the second width. The adjustable spacer can be made from a sponge material.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: An automated system that can be used for prosthetic heart valve manufacturing or suturing procedures. The system can include a first automated fixture that includes an articulating arm and a target device holder. The system can also include one or more additional automated fixtures, which can be configured as one or more suturing arms that include another articulating arm and a needle holder. The first automated fixture can be configured to rotate a target device held by the holder to allow the one or more additional automated fixtures to perform operations such as form sutures on the target device without intervention of a human operator. The system can include a display system configured to display status information of a suturing procedure.

Abstract: An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve. Other embodiments are also described.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for an implant, then return to a non-expanded state after the passage of the device. The sheath includes a foldable inner member having a detached flap structure at its distal tip that facilitates expansion of the sheath lumen to increased diameters, and an elastomeric distal end that reduces push and retrieval forces therethrough. The sheath can include a hemostasis seal on its proximal end to prevent the leakage of blood out of the sheath and prevent ballooning of outer layer of the sheath.

Abstract: An enlarged cardiac valve annulus can be reduced in diameter using a cord that is affixed to the annulus by a set of anchors. A knot or fixed loop is disposed at a first end of the cord, and the body of the cord passes through the knot or fixed loop so as to form (a) a loop portion positioned distally beyond the knot or fixed loop and (b) a second portion that runs between the knot or fixed loop and the second end. The body of the cord can slide with respect to the knot or fixed loop. After the anchors are implanted and a bond between the anchors and the annulus is sufficiently strong, pulling the second portion in a proximal direction while holding the knot or fixed loop in place will reduce the circumference of the annulus.

Abstract: A process of monitoring heart valve function involves placing one or more transducers on a patient's body, receiving, using the one or more transducers, one or more signals indicating a blood flow velocity profile associated with a heart of the patient, identifying a first peak in the blood flow velocity profile, and determining a severity of a dysfunction of a first heart valve of the heart based on the first peak.

Abstract: A delivery system for delivering a stent-mounted heart valve, or other implant, through an introducer sheath. The delivery system includes an elongate catheter supporting a capsule. The capsule contains the stent-mounted heart valve in the crimped condition. The capsule includes a protrusion extending from its outer surface for urging the sheath away from the outer surface capsule as it moves therethrough, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a leaflet construct including one or more leaflets. In some examples, the leaflet construct is coupled to the leaflet frame via a retention element. In some examples, the retention element is in the form of an outer frame that is coaxially arranged with the leaflet frame.

Abstract: A method of preparing a sterilized heart valve, the method comprising: compressing a compressible frame of a heart valve from an expanded configuration to a crimped configuration; the heart valve comprising the frame and a plurality of leaflets coupled to the frame; wherein each of the plurality of leaflets comprises a dry, unfixed, decellularized, antigen-free biological tissue that has been treated with a solution comprising a polyol or polyhydric alcohol; packaging the heart valve within a sealed packaging system while the heart valve is in the crimped configuration; and sterilizing the heart valve packaged within the sealed packaging system with one or more cycles of electron beam radiation.

Abstract: A prosthetic valve includes an annular frame and a skirt. The frame is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The skirt has a fold around an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame. When the frame is in the radially expanded configuration, an outer portion of the skirt tightly conforms to the outer surface of the frame and the inflow end of the frame is axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is in the radially compressed configuration, the inflow end of the frame extends axially so as to at least partially fill the axially extending gap.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: A sealing member for a prosthetic heart valve includes an annular fabric body having a first circumferential portion and a second circumferential portion. The first circumferential portion extends circumferentially around the annular fabric body and is resiliently stretchable in a direction along the longitudinal axis of the annular fabric body between an expanded configuration of the prosthetic heart valve and a collapsed configuration of the prosthetic heart valve. The second circumferential portion extends around the annular fabric body and is circumferentially offset from the first circumferential portion, the second circumferential portion being resiliently stretchable in a circumferential direction between the collapsed configuration of the prosthetic heart valve and the expanded configuration of the prosthetic heart valve.

Abstract: A device for deploying a suture clip onto a suture can include a proximal handle portion that includes an actuation mechanism. The device can also include an outer shaft defining an inner lumen. A crimping assembly can be at least partially disposed within a distal end of the outer shaft. The crimping assembly can include a plurality of crimping members configured to receive and radially compress a suture clip. The actuating mechanism can be configured to move the plurality of crimping members radially inwardly from a first position, where the crimping members are configured to receive a suture clip, to a second position where the plurality of crimping members are configured to radially compress the suture clip, causing the suture clip to plastically deform and become secured around one or more sutures.

Abstract: An expandable docking station includes an annular valve seat having an end, an annular outer wall comprising struts disposed around the valve seat, and links that connect the end of the annular valve seat to the annular outer wall. Each of the links extends from the struts of the annular outer wall directly toward a longitudinal axis that runs longitudinally through a center of the docking station, and to a corresponding one of a plurality of circumferentially spaced axially extending legs at least partially defining the annular valve seat. The outer wall is configured to conform to an interior shape of a blood vessel, when expanded inside the blood vessel, such that the outer wall can expand in multiple locations to conform to multiple bulges of the blood vessel and can contract in multiple locations to conform to multiple narrowed regions of the blood vessel.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a valved conduit. The valved conduit may include at least one leaflet and an interior surface that mitigates against thrombus formation within the conduit.