System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween. The first gripping element and the second gripping element each includes a plurality of barbs extending therefrom, the plurality of barbs of each of the first gripping element and the second gripping element being aligned transversely in at least one row. The fixation device further includes a covering disposed on each of the first gripping element and the second gripping element, wherein the plurality of barbs of the first gripping element and the second gripping element, respectively, protrude through the covering.

System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, and a fixation device releasably coupled to the delivery catheter. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween. The first gripping element and the second gripping element each include a plurality of barbs extending therefrom, the plurality of barbs of each of the first gripping element and the second gripping element being aligned transversely in at least one row. The fixation device further includes a covering disposed on each of the first gripping element and the second gripping element, wherein the plurality of barbs of the first gripping element and the second gripping element, respectively, protrude through the covering.

A device for closing an opening in tissue includes a shaft having a proximal end, a distal end, and a channel disposed between the proximal and distal ends. A pair of pins are disposed within the channel and cooperate with a slidable and axially movable foot. The foot extends distally from the channel with a flexible guidebody extending from a distal foot end of the foot.

A device and method for selectively engaging or penetrating a layer of a luminal organ wall where the luminal organ wall has a plurality of layers including an outermost layer and an innermost layer adjacent to the lumen of the organ. The device and method select one of the plurality of layers of the organ wall other than the innermost layer and deploy from within the lumen of the organ a tissue device through the innermost layer to a specific depth to engage or penetrate the selected one of the plurality of layers. The device and method may be employed to create luminal pouches or restrictive outlets. In a stomach organ, the device and methods may be employed to treat obesity by forming a gastric pouch with or without a restrictive outlet.

A method of removing needles operatively associated with suture through tissue surrounding an access tract, the method comprising advancing an elongate distal member along the access tract, locating an elongate proximal member in contact with tissue surrounding the puncture site, the elongate proximal member comprising a guide disposed within the elongate proximal member, a perimeter of the guide forming a plurality of needle receiving gaps that are circumferentially spaced about a needle deployment actuator with a portion of the guide disposed between adjacent needle receiving gaps extending outwardly towards a wall of the lumen of the elongate proximal member, the needle deployment actuator extending to the elongate distal member and being configured to initiate proximal movement of a needle toward an opening of the elongate proximal member, and actuating the needle deployment actuator to move the needle toward the opening of the elongate proximal member.

A bi-directional medical suturing device includes a first needle; a second needle being disposed distal to the first needle; a first thread control member including a first holding portion being movable between a position where the first holding portion prevents a movement of the first needle and a position where the first holding portion does not prevent the movement of the first needle; and a second thread control member including a second holding portion being located the first holding portion, the second holding portion being movable between a position where the second holding portion prevents a movement of the second needle and a position where the second holding portion does not prevent the movement of the second needle.

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.

In accordance with the present invention there is provided apparatuses and methods for using a medical instrument including a sizing and positioning adapter. The apparatus comprises an adapter for a medical instrument, the adapt having a body having a shim portion and an instrument holding portion adjacent the shim portion, wherein the shim portion provides an enlarged peripheral surface adjacent the medical instrument such that when the medical instrument is held in the instrument holding portion and the medical instrument and body are inserted through an opening in a patient tissue, at least a portion of the enlarged peripheral surface is in contact with at least a portion of the periphery of the opening in the patient tissue.

In accordance with an aspect of the present disclosure, an apparatus for suturing tissue is provided that includes a body having a proximate end and a distal end. A suturing head is coupled to the distal end of the body, including a first set of curved needles, a second set of curved needles, and a plurality of sutures. A first end of a suture is coupled to one of the curved needles of the first set. A second end of the suture is coupled to one of the curved needles of the second set. The curved needles of the first set are oppositely oriented to the curved needles of the second set. The suturing head can be positioned between two substantially parallel sections of tissue. An actuator is coupled to the body to deploy the first and second sets of curved needles.

An assembly includes a flexible fixation member, a suture, and a delivery device. The fixation member includes a body with two terminal ends. A suture passes through the flexible fixation member at various points along a length of the body such that portions of the fixation member are slidable relative to the suture and configurable to form a cluster within a surgical site. The delivery device includes a tubular member, an elongated inserter, and a trigger. The elongated inserter is slidably disposed within the tubular member. The inserter has a forked distal end configured to receive a portion of the flexible fixation member and the suture. The trigger is finger-engagable and fixedly coupled to the proximal end of the inserter. It is configured to advance and retract the inserter relative to the tubular member. The trigger includes a retention member for retaining a proximal end portion of the suture.