Abstract: Described herein are devices and methods for mitral valve repair. The devices and methods implant a plurality of distal anchors at an annulus of the mitral valve (e.g., the posterior annulus) and tension artificial chordae to pull the portion of the annulus toward an opposite edge and inward into the ventricle. This can effectively reduce the size of the orifice and increase coaptation. The delivery devices can be configured to be actuated to form a distal anchor made of a pre-formed knot. The delivery devices deliver the pre-formed knot in an elongate configuration. Actuation of the delivery device causes the pre-formed knot to transition from the elongate configuration to the deployed configuration by approximating opposite ends of a suture coupled to a coiled configuration to form one or more loops. After formation of the knot, the delivery device can be withdrawn.

Abstract: Described herein are methods and apparatus for approximating targeted tissue using locking sutures. The locking sutures can be configured to receive suture ends that are interweaved through portions of the locking sutures. In a pre-deployment configuration, a locking suture can slide along suture tails and can be positioned at a target location within a target region. Once a desired position and/or tension is achieved, the locking suture can be transitioned to a post-deployment configuration where the locking suture constricts around the suture tails to inhibit relative movement between the suture tails and the locking suture. A visualization system can be used to provide visual feedback with respect to approximating the targeted tissue and the locking sutures.

Abstract: An introducer device includes a proximal hub including a first port and a second port, first and second fluid valves associated with the first port and the second port, respectively, a first elongate lumen projecting distally from the proximal hub, the first elongate lumen being in fluid communication with the first port, and a second elongate lumen projecting distally from the proximal hub, the second elongate lumen being in fluid communication with the second port and fluidly isolated from the first elongate lumen.

Abstract: Described herein are methods and apparatus for approximating targeted tissue using locking sutures. The locking sutures can be configured to receive suture ends that are interweaved through portions of the locking sutures. In a pre-deployment configuration, a locking suture can slide along suture tails and can be positioned at a target location within a target region. Once a desired position and/or tension is achieved, the locking suture can be transitioned to a post-deployment configuration where the locking suture constricts around the suture tails to inhibit relative movement between the suture tails and the locking suture.

Abstract: Described herein are cords (or sutures) and methods for using cords wherein the cords comprise a synthetic aromatic polyamide (or aramid) polymer, wherein the cords comprise a core of a high-strength material such as a polymer (e.g., PET), aramid, ceramic, or metal with a coating of ePTFE encapsulating the core, or wherein the cords comprise braided strands of ePTFE. The disclosed cords have higher strength and durability than typical ePTFE cords or sutures. Furthermore, disclosed herein are methods that utilize the disclosed cords in cardiac repairs, thereby resulting in repairs that are superior to repairs that utilize typical ePTFE cords.

Abstract: A tissue anchor delivery device includes a handle, an elongate shaft extending from the handle, a pusher tube disposed at least partially within a lumen of the elongate shaft, a pusher hub coupled to the pusher tube, a needle disposed at least partially within a lumen of the pusher tube, a needle hub coupled to the needle, and an actuator configured to be fixed to the pusher hub and the needle hub. The actuator is further configured to advance the needle hub and the pusher hub a first distance, thereby causing a tip of the needle to protrude from a distal end of the elongate shaft, disengage from the needle hub, and advance the pusher hub a second distance relative to the needle hub, thereby causing a distal end of the pusher tube to advance over the needle and push a coiled suture form off of the needle.

Abstract: A delivery system comprises two or more needles including at least a first needle comprising a distal tip configured to pierce a valve leaflet of a heart, two or more leaflet anchors, each of the two or more leaflet anchors configured to be delivered via one of the two or more needles, and a shaft comprising a first interior lumen configured to slidably receive the two or more needles, the shaft having a first opening into the first interior lumen at a distal end of the shaft, the first opening configured to allow at least the first needle to exit the shaft.

Abstract: A suture system can comprise a first and a second curved double arm needle, and a needle docking device configured to maintain the first and the second curved double arm needles in alignment with and parallel to one another and at predetermined orientations relative to the needle docking device. The system can include a needle manipulating instrument having a distal portion configured to engage the first and the second curved double arm needles while the first and second curved double arm needles are in the needle docking device, and to maintain the needles in predetermined orientations.

Abstract: A method comprises advancing an elongate tube to a target implantation site, the elongate tube having a needle disposed at least partially therein that has a coiled sutureform wrapped around at least a portion thereof, contacting a distal end of the elongate tube to a target tissue, projecting a tip of the needle from the distal end of the elongate tube to pierce through the target tissue such that the tip of the needle and at least a portion of the coiled sutureform project through the target tissue, advancing a pusher device within the elongate tube and over the needle to push the at least a portion of the coiled sutureform off of the tip of the needle, and proximally pulling one or more suture tails associated with the coiled sutureform to form the coiled sutureform into a knot on a distal side of the target tissue.

Abstract: Described herein are devices for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.

Abstract: A medical device shaft includes a rigid, elongate shaft, an end effector form coupled to a distal end of the elongate shaft, and echogenic additives associated with at least one of the elongate shaft and the end effector. The shaft exhibits improved echogenicity, and is suitable for devices that are manipulated or positioned with under echo guidance.

Abstract: Described herein are methods and apparatus for implanting grafts to leaflets for cardiac procedures that are performed minimally-invasively while the heart is beating. The graft elongates, reinforces, and patches the leaflet. In certain disclosed examples, the graft is secured to the atrium or ventricle side of the leaflet with an artificial cord implanted on an edge of the graft to improve coaptation. In some disclosed examples, the graft is secured to both leaflets to enable an edge-to-edge procedure similar to the Alfieri technique. Some examples of the disclosed methods including introducing the graft into the ventricle and guiding it into place using artificial cords previously implanted in the leaflet.

Abstract: A method of suturing a tissue opening can comprise placing a tissue-facing surface of a first pad, a second pad and a third pad over respective tissue areas adjacent to the tissue opening. The second pad can be positioned on a first side of the first pad and the third pad can be positioned on a second side of the first pad. The first and second pads can be coupled to a suture, the suture forming a stitch over the upper surface of each of the respective pads. The suture can be stitched through an area of tissue between the first pad and the second pad, between the second pad and the third pad, and between the third pad and the first pad. A first distal portion and a second distal portion of the suture can be coupled to the third pad for forming the purse-string suture.

Abstract: Described herein are methods and apparatus for approximating targeted tissue using locking sutures. The locking sutures can be configured to receive suture ends that are interweaved through portions of the locking sutures. In a pre-deployment configuration, a locking suture can slide along suture tails and can be positioned at a target location within a target region. Once a desired position and/or tension is achieved, the locking suture can be transitioned to a post-deployment configuration where the locking suture constricts around the suture tails to inhibit relative movement between the suture tails and the locking suture.

Abstract: Described herein are methods and apparatus for approximating targeted tissue using locking sutures. The locking sutures can be configured to receive suture ends that are interweaved through portions of the locking sutures. In a pre-deployment configuration, a locking suture can slide along suture tails and can be positioned at a target location within a target region. Once a desired position and/or tension is achieved, the locking suture can be transitioned to a post-deployment configuration where the locking suture constricts around the suture tails to inhibit relative movement between the suture tails and the locking suture.

Abstract: Described herein are methods and apparatus for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.

Abstract: A method comprises advancing an elongate tube to a target implantation site, the elongate tube having a needle disposed at least partially therein that has a coiled sutureform wrapped around at least a portion thereof, contacting a distal end of the elongate tube to a target tissue, projecting a tip of the needle from the distal end of the elongate tube to pierce through the target tissue such that the tip of the needle and at least a portion of the coiled sutureform project through the target tissue, advancing a pusher device within the elongate tube and over the needle to push the at least a portion of the coiled sutureform off of the tip of the needle, and proximally pulling one or more suture tails associated with the coiled sutureform to form the coiled sutureform into a knot on a distal side of the target tissue.

Abstract: Described herein are devices and methods for mitral valve repair. The devices and methods implant a plurality of distal anchors at an annulus of the mitral valve (e.g., the posterior annulus) and tension artificial chordae to pull the portion of the annulus toward an opposite edge and inward into the ventricle. This can effectively reduce the size of the orifice and increase coaptation. The delivery devices can be configured to be actuated to form a distal anchor made of a pre-formed knot. The delivery devices deliver the pre-formed knot in an elongate configuration. Actuation of the delivery device causes the pre-formed knot to transition from the elongate configuration to the deployed configuration by approximating opposite ends of a suture coupled to a coiled configuration to form one or more loops. After formation of the knot, the delivery device can be withdrawn.

Abstract: In some embodiments, an apparatus includes a handle, an actuator, a pusher device, and a puncture member. A distal anchor is disposed at a distal end portion of an artificial chorda, or suture, and is in a delivery configuration. The artificial chorda, or suture, is coupled to the actuator and extends through a lumen of the puncture member. The actuator can be actuated to move the puncture member distally a preset distance, and to move the pusher device distally such that at least a portion of the distal anchor is moved distal to the distal end of the puncture member and the distal anchor is moved from its delivery configuration to a deployed configuration.

Abstract: Described herein are devices and methods for mitral valve repair. The devices and methods implant a plurality of distal anchors at an annulus of the mitral valve (e.g., the posterior annulus) and tension artificial chordae to pull the portion of the annulus toward an opposite edge and inward into the ventricle. This can effectively reduce the size of the orifice and increase coaptation. The anchor points of the artificial chordae can be offset from the apex of the heart to achieve a targeted force vector on the annulus. In addition, some embodiments include distal anchors implanted in the posterior leaflet in addition to those at the posterior annulus. This allows differential tensioning to be applied to provide for greater flexibility in treating various configurations of mitral valves to improve coaptation.