Abstract: Apparatus for repairing a leaflet of a heart valve can include a leaflet-plicating tool that can include leaflet-capture arms and a helical needle. The needle can be operatively coupled to the leaflet-capture arms. The leaflet-capture arms can include an arm-shaft, each configured to house a leaflet-engaging member. The leaflet-capture arms can be configured to use the leaflet-engaging members, extended over the leaflet from the annulus toward a free edge of the leaflet, to form a plication in the leaflet of the heart valve between the leaflet-capture arms. The leaflet-plicating tool can be configured to secure the plication by using the helical needle to stitch a suture helically along the plication. Other embodiments are also described.

Abstract: Certain aspects of the disclosure concern a device for repairing or replacing a native heart valve. The device can include a frame including a first set of struts intersecting with a second set of struts at a plurality of strut connection points. The frame can be radially expandable from a radially collapsed state to a radially expanded state. The device can include at least one expansion feature including a screw head and a screw shaft connected to the screw head. The screw shaft can extend through a first strut connection point and a second strut connection point. The device can further include a plurality of penetrating members extending from a first end of the frame. Rotating the screw shaft in a first direction can radially expand the frame from the radially collapsed state to the radially expanded state.

Abstract: Devices and methods for retrieving percutaneously implanted catheter systems such as a heart valve repair system. The devices include at least one locking connector at the distal end of a flexible elongated extension for coupling to an implanted tubular member. The locking connector may be a tubular anchor having a pair of distal prongs which are biased outward and face in a proximal direction, as well as an expandable auxetic midsection. Inserting the tubular anchor into the implanted tubular member flexes the distal prongs inward such that they prevent proximal movement of the tubular anchor. A user pulls on the proximal end of the tubular anchor to expand the auxetic midsection and lock the two pieces together. The devices and methods are particularly useful to attach extensions to implanted concentric tubes to enable relative axial force application.

Abstract: A flexible delivery catheter can be used to deploy valve repair and replacement devices at an implant site for the repair or replacement of poorly functioning native heart valves. Such a catheter can include a flexible tube having a plurality of links. A control wire can be connected to the plurality of links, such that applying tension to the control wire causes the flexible tube to bend.

Abstract: An assistance system that can be used for prosthetic heart valve manufacturing or suturing procedures includes an automated fixture that can comprise an articulation arm and a target device holder. The target device holder can be positioned and oriented to reduce operator strain during a manufacturing or inspection process. The assistance system includes a user input device enabling the operator to move between positions to assist in such processes. The assistance system can also be trained by capturing sequences of position data corresponding to a manufacturing or inspection process.

Abstract: A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.

Abstract: A knotless suture fastener installation system for securing medical devices such as cardiac implants. The knotless suture fasteners may be spring-biased so as to grip onto sutures passed therethrough. The system includes a fastener deployment tool with a proximal handle and a distal shaft to which a fastener cartridge attaches. A plurality of disposable cartridges are sequentially attached to the end of the deployment tool and used to secure the medical implant one fastener at a time. The deployment tool may also cut the sutures being fastened.

Abstract: A packaging assembly for storing a bioprosthetic heart valve is disclosed. The packaging assembly can include a sub-assembly comprising a valve holder configured to hold the bioprosthetic heart valve, and a clip configured to receive a shaft of the valve holder. The clip can comprise a body having an outer periphery and opposing inner edges. The opposing inner edges can define a slot in the body for receiving the shaft of the valve holder. The slot can be open at a first end of the body and extend, along a longitudinal axis of the body, from the first end to a docking aperture. The clip can further comprise a compliance feature in an interference-fit area of the slot adjacent to the docking aperture. The compliance feature can comprise a cutout adjacent to each of the opposing inner edges such that each of the opposing inner edges defines a beam within the interference-fit area.

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: An apparatus is provided for use with a tissue anchor and an anchor driver. The apparatus includes a housing, shaped to define a channel. The channel includes (i) an anchor-storage zone, and (ii) a proximal opening configured to provide access for the anchor driver to the anchor-storage zone. The channel is configured to enable sliding of the tissue anchor therewithin to be stored in the anchor-storage zone. The apparatus also includes a retaining member, shaped to define a cradle for cradling and holding the tissue anchor in the anchor-storage zone. The retaining member includes a pillar pivotable with respect to the cradle, and configured to support the tissue anchor at the cradle. Other embodiments are also described.

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: 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 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: 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: 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 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.