Abstract: A method and device for wound closure is provided. One advantage of wound closure devices and methods shown includes a simple and inexpensive modified suture with increased pullout resistance to close wounds in eyes and prevent leakage. Another advantage includes a visualization tool to aid in locating the wound on the eye.

Abstract: Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient's vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.

Abstract: Among other things, there are disclosed embodiments of devices used for minimally-invasive treatments, such as treatment of mitral valves. In a system for placing an annuloplasty belt around the heart, embodiments for tensioning a suture associated with the belt are provided, as are embodiments of a suture lock for holding the suture with the applied tension. A delivery device that permits placement and tensioning of such a belt and activation of the suture lock in one procedure is also disclosed. Methods for making and using these features are also disclosed.

Abstract: A braided barbed suture includes a barbed monofilament insert including an elongated core having a thickness and a plurality of barbs projecting outwardly from opposite sides of the elongated core. The braided barbed suture includes a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture. The composite core has a thickness and the elongated core is located in a center of the composite core. The elongated core thickness is about 6-8 mil and the composite core thickness is about 13-18 mil. A ratio of the elongated core thickness relative to the composite core thickness is between about 0.16 to 0.91. The elongated core has transition zones that form a concave profile. The braided barbed suture has a single breaking point for both the braided sheath and the barbed monofilament insert. The barbed monofilament insert has a PDS monofilament core, and the braided sheath is a VICRYL multifilament yarn braided sheath.

Abstract: The disclosure provides a dynamic vascular access and closure device for radial cinching of an access site. The device includes a tensioning tube, a resilient member disposed within the tensioning tube, and a plurality of sutures extending axially between a distal end of the tensioning tube and a proximal end of the tensioning tube. A proximal end of each of the plurality of sutures can be configured to attach to the resilient member such that movement of that suture causes compression or extension of the resilient member within the tensioning tube to provide cinching to the sutures.

Abstract: A method includes positioning a surgical tool with an end effector adjacent a surgical site, the end effector including a housing having a tapered section that defines an inner surface, first and second arcuate jaw members protruding distally from the housing and defining a channel therebetween, each arcuate jaw member exhibiting a curved profile shaped to receive an arcuate surgical clip, and a feedbar movable within the housing. The method further including urging the arcuate surgical clip against the inner surface, advancing the feedbar within the housing to engage and follow the inner surface and thereby flexing the feedbar downward and into engagement with the arcuate surgical clip, advancing the arcuate surgical clip with the feedbar into interposition between the first and second arcuate jaw members, and collapsing the first and second arcuate jaw members to crimp the arcuate surgical clip.

Abstract: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

Abstract: A system to assist delivery of a mechanical intravascular treatment device, wherein the system includes a first assist device having a first linear sliding mechanism. The linear sliding mechanism includes: a first non-slidable section; a first slidable section linearly displaceable relative to the first non-slidable section; and a first tension device connected to the first slidable section to move together; the first tension device being transitionable between an unsecured state and a secured state. A first securing hub is fixedly attached to the first non-slidable section, wherein the first securing hub is transitionable between an unsecured state and a secured state. The system may also include a second assist device. The assist devices provide enhanced control of movement of the delivery wire and/or guide catheter.

Abstract: Embodiments hereof relate methods of delivering a valve prosthesis to an annulus of a native valve of a heart. A valve delivery system is introduced into a ventricle of the heart via a ventricular wall of the heart. The valve delivery system has a displacement component at the distal portion thereof. The valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has a first outer diameter. While the valve prosthesis is in the delivery configuration, the displacement component of the valve delivery system is radially expanded into an expanded state in which the displacement component has a second outer diameter greater than the first outer diameter. The valve delivery system is advanced towards the annulus of the native valve of the heart with the displacement component in the expanded state to displace chordae tendineae.

Abstract: A clot removal device for removing clot from a body vessel comprising an expandable structure and an elongate member. The elongate member can have a proximal end and a distal end, the elongate member being connected to the expandable structure at its distal end. The expandable structure can have a constrained delivery configuration, an expanded clot engaging deployed configuration, and an at least partially constrained clot pinching configuration. At least a portion of the expandable structure can be configured to engage clot in the expanded deployed configuration and to pinch clot on movement from the deployed configuration to the clot pinching configuration.

Abstract: Cartridges configured to hold anchors and associated locking sutures and a common suture used in an array of anchors. A suture anchor array is connected in series by a single working suture and each of the suture anchors allows tensioning of the working suture between itself and the prior anchor implanted in the serial string. Further, each anchor includes a suture lock having a free tail that can be pulled to lock the working suture in place subsequent to tensioning. This creates an independently tensioned suture bridge between each implanted suture anchor and the just previously implanted anchor. The cartridges are configured to securely hold an individual anchor and store the tail of the suture lock, while allowing flossing of anchors along the common suture.

Abstract: Embolization particles can be safely delivered to the left gastric artery of a patient by introducing the distal end of a catheter in the patient's left gastric artery, inflating a balloon located near the distal end of the catheter so that the balloon prevents blood from flowing through the left gastric artery, and injecting a mixture of particles and contrast agent into the proximal end of the catheter so that they flow through the catheter. In addition, a path is provided for blood to flow into the catheter through an opening in the sidewall of the catheter at a position that is proximal to the balloon, and out through the distal end of the catheter. This blood flow helps to carry the particles along to their destination in the distal portion of the left gastric artery. The particles are also prevented from flowing into portions of the patient's artery system that are proximal of the balloon.

Abstract: Vascular access devices, systems, and methods of their use are provided. In one embodiment, a vascular access device includes a catheter, a balloon, and an inflation lumen. The catheter includes an elongate flexible shaft having a proximal end and a distal end with a primary lumen therethrough. The balloon is disposed about the distal end of the catheter. The inflation lumen is in fluid communication with the balloon and extends toward the proximal end of the shaft of the catheter. The balloon is inflatable into a shape having a first open end, a second open end, a sidewall between the first and second open ends, and a passageway therethrough, which, when the balloon is deployed and inflated within a vessel, permits blood flowing in the vessel to flow through the passageway.

Abstract: A tissue anchor system includes a fixation device and a tool. The fixation device includes a tab connected to a tissue anchor. The tool includes a shaft connected between a proximal handle portion and a distal tip. The distal tip is configured to limit movement of the fixation device during loading of the tissue anchor.

Abstract: Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.

Abstract: Methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. A delivery device for staged deployment of an implantable device to a target area. The delivery device includes a deployment handle and one or more lock lines extending from the deployment handle through the catheter to the implantable device, the one or more lock lines being configured to engage with the implantable device to allow locking of the implantable device.

Abstract: A suture device for use in combination with a delivery system including a lumen extending through the delivery system includes a needle usable to carry a suture, a distal shuttle configured to releasably secure the needle, a sleeve disposable over the distal shuttle, the distal shuttle movable relative to the sleeve between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is releasable from the distal shuttle. A shaft is operably coupled to the sleeve and a control wire is operably coupled to the distal shuttle. A needle may include a needle cap.

Abstract: A slip knot suture construct system and method for securing multiple limbs of suture. The system includes a suture construct having a length of suture including a standing limb with a standing terminal end and a closing limb with a closing terminal end. The suture construct has three loops: a primary loop formed in the closing limb, the primary loop and closing limb extending to the standing limb, a secondary loop formed in the standing limb, and a locking loop formed in the length of suture between the primary loop and the secondary loop. A limb of suture extends through the primary loop. The limb of suture is secured in the suture construct by pulling the closing terminal end proximally, which pulls the primary loop holding the limb of suture through the locking loop and at least partially into the secondary loop.

Abstract: An intraosseous screw for deposit into a bone structure and retaining a soft tissue therein. The intraosseous screw includes a body and a retention member. The body defines an axial cavity in which soft tissue can be deposited and a window that permits the soft tissue to contact the bone structure in which the intraosseous screw is deposited. The retention member is positioned within the axial cavity and at least partially defines an opening through which a suture connected to soft tissue can pass to facilitate anchoring of the soft tissue within the axial cavity. The intraosseous screw can be combined with a passing suture, driver, and/or peg to provide a system for associating soft tissue with a bone structure. The intraosseous screw can be utilized in a method in which soft tissue is deposited into a bone structure after the interosseous screw is fully deposited in the bone structure.

Abstract: An Achilles tendon repair device comprises a handle for physician gripping and base having a first set of tendon rods disposed in an arcuate or U-shaped pattern about the base to engage the posterior surface of the tendon and impart a contour, or drape, the tendon in the posterior-anterior plane to increase the surface area for suturing. A second set of suture guide rods extend from the sides of the base and are spaced apart to allow insertion of suture needles along the entire length of the suture guide rods, and at any angle. A suture needle housing guide can be slidingly attached to the suture guide rods and includes sidewalls with predefined suture holes/angles. An adjustable clamping arm can engage the tendon's posterior surface such that the device grasps the tendon on both the anterior and posterior tendon surfaces simultaneously, while increasing posterior-anterior plane surface area to facilitate suturing.