Described are devices, implants, kits, and related methods for treating pelvic conditions such as urinary in incontinence, in a male or a female patient. The invention includes, in one embodiment, a multi-piece implant, including a tissue support piece, extension portion, and one or more self-fixating tips. The device may be employed through a medial incision in the pelvic region of the patient.

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. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.

A readily implantable knotless suture anchor that de-couples the angle of insertion of the anchor from the tissue passage step and other steps of conventional procedures. An anchor provides an internal locking mechanism configured such that: suture knots do not have to be tied; suture and tissue tension can be easily adjusted intraoperatively; and suture passage and tensioning can be done at a variety of positions and angles. A method includes: passing a first suture through a patient's tissue and then through a loop of a shuttle suture; pulling the free end of the shuttle suture until the first suture passes through an internal suture locking mechanism; applying tension in the first suture until adequate tension is achieved with respect to the tissue; automatically engaging an internal locking member; and securing the first suture against further relative movement with respect to the anchor.

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.

Meniscal repair devices, systems, and methods are provided.

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes a tether fixer assembly configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The fixer assembly defines a lumen configured to receive therethrough a tether extending from the prosthetic valve and a movable portion. The fixer assembly is movable between a first configuration, in which the movable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether. The fixer assembly can be disposed against an epicardial pad positioned on the outside surface of the heart when in the second configuration to secure the prosthetic valve, the epicardial pad and tether in a desired position within the heart.

Anchor delivery systems include anchors having a generally cylindrical body with a rail on top for positioning within a delivery device slot. The rail incorporates a side-bulge as a retaining feature which axially extends along a majority of the length of the rail. The bulge interferes with a corresponding hourglass cutout in the delivery device slot to prevent the anchor from stripping out of the delivery device when the delivery device is retracted through tissue. The anchors are symmetrical along a length and width to facilitate loading within the delivery device. The distal portion of the delivery device includes a series of distally-extending barbs that intentionally change the penetration force required to push the device tip through tissue.

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. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.

Apparatus for securing an object to bone, the apparatus comprising: an anchor, the anchor comprising: a body comprising an opening for receiving a filament therein; and a locking element movably mounted to the body for selectively locking the filament to the body; and an inserter for deploying the anchor in bone, the inserter comprising: a handle; an overtube extending distally from the handle; a carriage movably mounted to the handle; a shaft movably mounted within the overtube and connected to the carriage and releasably connected to the body of the anchor, the shaft being hollow; and a rod movably mounted within the shaft and connected to the locking element.

An epicardial anchor device may include a base and a hub each defining a radial slot. The hub is received within, and is rotatable relative to, the base. The radial slot of the hub defines a tether passageway for receiving a tether coupled to a prosthetic heart valve. The epicardial anchor device may have an unlocked configuration in which the radial slot of the base aligns with the radial slot of the hub so that the tether may be slid laterally through the radial slot of the base, and a locked configuration in which the radial slot of the base is out of alignment with the radial slot of the hub so that the tether cannot be slid laterally away from the radial center of the hub. Rotation of the hub may transition the epicardial anchor device from the locked to the unlocked configuration.