Abstract: Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

Abstract: An ultrasonic catheter assembly includes a sheath having a sheath lumen. A core wire is at least partially disposed within the sheath lumen. The core wire has a proximal portion and a distal portion. The proximal portion of the core wire is configured to be coupled to an ultrasound-producing mechanism. A working length of the distal portion of the core wire extends distally from the sheath. The working length is configured for longitudinal displacement, transverse displacement, or a combination of longitudinal and transverse displacement, in accordance with a plurality of output modes for vibrational energy supplied to the core wire proximal portion by the ultrasound-producing mechanism.

Abstract: A suture passer which is sized and shaped to be inserted through the femoral notch during a meniscal repair. The suture passer includes upper and lower jaws that may be straight or that may have an angled offset in relation to the common axis of the suture passer in order to gain an indirect access to meniscal tissue in a constricted space. The jaws of the suture passer may be angled, either to the left or to the right, up to 45 degrees from the central axis of the shaft. The suture passer is also able to grasp meniscal tissue prior to suture passing. A nitinol needle housed within one of the jaws can then be deployed to pass a preloaded suture through the tissue to be captured on the opposite side of the tissue.

Abstract: A method for closing a puncture in tissue that includes advancing a guide member into proximity with the tissue, the guide member having a needle guide, positioning a distal end of the guide member with the needle guide toward the tissue to present an opening of the needle guide toward the tissue the needle guide cooperating with a suture securing device that is slidably coupled to the guide member and a suture attached to the suture securing device, deploying the suture securing device, the suture securing device comprising a body with an anchor point for the suture and features that allow the suture securing device to pierce the tissue and resist retraction through the tissue, and establishing tension in the suture to move the suture securing device toward another suture securing device to thereby close the puncture in the tissue.

Abstract: An improvement to devices and methods for suturing tissue in various applications, such as percutaneous closure of arterial and venous puncture sites and the like, providing a self-locking or self-securing suture that does not require manual knot-tying to hold in apposition the tissue of the vessel wall on opposite sides of the puncture.

Abstract: Systems and methods for harvesting tissue from a donor site include first and second conduits through which a flexible saw component is guided. Certain embodiments include a mechanism which facilitates insertion of a flexible cutting member component parallel to a transverse plane and slicing a graft parallel to the coronal plane to extract the graft.

Abstract: Delivery devices for delivery of a stented prosthetic heart valve. Various delivery devices include an outer sheath assembly including an outer sheath connected to a capsule that is advanced proximally to retain the prosthetic valve, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper to provide a smooth transition of the capsule over the prosthetic valve during loading and recapture procedures. The bumper is expandable from a first position to a second position in which a distal end of the bumper is expanded to increase its diameter. The bumper can be biased in the second, expanded position so that the bumper automatically transitions to the expanded position upon retraction of the outer sheath.

Abstract: An expansile member that may be used on a delivery device or may be used for occlusive purposes within the vasculature.

Abstract: Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle.

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 method of and a system for treating a lesion. A waveguide is inserted into a vessel of a subject, with the lesion being present in the vessel and the waveguide extending longitudinally between a proximal end and a distal end. The distal end of the waveguide is positioned adjacent to the lesion, and a high amplitude broadband mechanical pulse is generated and propagated from the proximal end to the distal end of the waveguide. At least a portion of the high amplitude broadband mechanical pulse is propagated from the distal end of the waveguide to the lesion, with the at least a portion of the high amplitude broadband mechanical pulse propagating up to the lesion, thereby treating at least partially the lesion.

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.

Abstract: Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle.

Abstract: A locking member of a suture locking device includes a loop portion formed in an ?-shape when viewed from a width direction, and a pair of extensions extending from the loop portion towards a distal side, and an intersection portion in which the pair of extensions intersect is formed at a distal end of the loop portion. The loop portion is inserted into the hollow portion from the distal side with the thread being inserted through an inner space of loop portion, and the thread is pulled from a proximal side towards the intersection portion in the inner space of the loop portion so that the thread is locked to the loop portion.

Abstract: A delivery system for delivering and deploying stent grafts having a proximal stent includes a first lumen and a stent capture device including a capture portion fixedly connected adjacent a first lumen distal end. An outer catheter has a catheter distal end and a catheter inner diameter. A second lumen having a second distal end is slidably disposed about the first lumen and within the outer catheter. A stent graft sheath has a sheath proximal end connected to the second distal end and disposed about the first lumen. The sheath has a sheath distal end and a sheath inner diameter greater than the catheter inner diameter for holding a compressed stent graft. A distal nose cone has a cone proximal end connected to either the capture portion or the first distal end. The nose cone and the capture portion are movably adjustable to selectively capture the sheath distal end therebetween.

Abstract: Devices and methods are described for delivering aneurysm stabilizing substances that may act in more than one pathway to the aneurysmal wall to prevent further enlargement of an aneurysm while allowing blood flow through the treatment area. Methods, devices and features for removal of the delivery device after the treatment are also disclosed.

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 material for use in a medical device includes a blend of a non-melt polymer such as Polyamideimide, a meltable carrier polymer such as Polyetherketoneketone and lubricants/rheology modifiers such that the final polymer material can be extruded, pelletized and used to injection mold components for the medical device. The ratios of the Polyamideimide, Polyetherketoneketone and the lubricants are selected to provide sufficient lubricity and glass transition temperature to the material to make it appropriate for use in high temperature applications and additive manufacturing processes.

Abstract: Closure devices and methods are provided for ligating tissue, such as the left atrial appendage. Generally, the closure devices include an elongate body, a snare loop assembly comprising a snare and a suture loop, and a shuttle connected to the snare and releasably coupled to the elongate body and retractable therein. In some variations, the shuttle may be configured to fit into the lumen. In other variations, a handle may be attached to the elongate body, and the handle may comprise a track and a snare control coupled to the track. The handle may be configured to release the shuttle from the elongate body and allow movement of the snare control along the track to retract the snare loop and the shuttle into a lumen of the elongate body.

Abstract: An embodiment provides a method for normalizing cardiac venous return, including: inserting percutaneously a calibrated balloon catheter through a femoral vein; advancing the calibrated balloon catheter to the inferior vena cava; and placing a balloon portion of the calibrated balloon catheter at a location before the drainage point of the hepatic vein.