Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point. Adjustable anchor assemblies, as well as anchor delivery systems, are also provided.

Abstract: Apparatus for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

Abstract: Apparatus and methods for optimizing anchoring force are described herein. In securing tissue folds, over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable arms configured to minimize contact area between the anchor and tissue. When the anchor is in its expanded configuration, a load is applied to the anchor until it is optimally configured to accommodate a range of deflections while the anchor itself exerts a substantially constant force against the tissue. Various devices, e.g., stops, spring members, fuses, strain gauges, etc., can be used to indicate when the anchor has been deflected to a predetermined level within the optimal range. Moreover, other factors to affect the anchor characteristics include, e.g., varying the number of arms or struts of the anchor, positioning of the arms, configuration of the arms, the length of the collars, etc.

Abstract: A surgical access device includes a single valve that forms a seal with the body wall and provides an access channel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal with instruments having a full range of instrument diameter. The valve can include a gel and preferably an ultragel comprised of an elastomer and an oil providing elongation greater than 1000 percent and durometer less than 5 Shore A. The single valve can be used as a hand port where the instrument comprises the arm of a surgeon, thereby providing hand access into the cavity.

Abstract: A method of reducing the cross-sectional area of a gastrointestinal lumen is provided wherein a delivery catheter having a needle, one or more anchors disposed within the needle and a suture coupled to each anchor is advanced into the gastrointestinal lumen, the needle extended through the tissue wall, and an anchor ejected from a distal tip of the needle through the tissue wall. The needle is then repositioned against an opposing tissue wall, another anchor deployed from the needle through the opposing tissue wall, and the tissue walls approximated by applying tension to the sutures.

Abstract: A surgical access device includes a single valve that forms a seal with the body wall and provides an access channel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal with instruments having a full range of instrument diameter. The valve can include a gel and preferably an ultragel comprised of an elastomer and an oil providing elongation greater than 1000 percent and durometer less than 5 Shore A. The single valve can be used as a hand port where the instrument comprises the arm of a surgeon, thereby providing hand access into the cavity.

Abstract: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue grasping member attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the tissue grasping member. In an embodiment, the tissue grasping member includes a pair of jaws configured to open to an included angle between the jaws of 180 degrees or more. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.

Abstract: An access system comprises an access device. The access device is adapted to be disposed within an opening in a body wall. The access device has an external flange adapted to be disposed external to the body wall and an internal flange adapted to be disposed internal to the body wall. Holes extend through the access device between an external surface and an internal surface of the access device. The holes span the thickness of the body wall between a location external to the body wall and a location internal to the body wall. The access device is formed of an elastomeric material adapted to conform to surfaces of instruments inserted through the holes to form instrument seals along at least a portion of a length spanning the thickness of the body wall. The elastomeric material is compressible and adapted to form a seal with the body wall.

Abstract: The attenuation or isolation of environmental parameters on a gastric lumen is described herein. Once tissue plications are formed into a gastric lumen or sleeve within a stomach, the newly formed lumen is subjected to a multitude of fluctuating stresses or pressure from food or fluids passing therethrough, from naturally-occurring contractions, and/or from changes in pH levels from caustic stomach acids and hormones. The tissue interface between these plications can be isolated from such environmental fluctuations, or the fluctuations can be attenuated, by a number of methods. One example is to place a gastric stent or sleeve within the newly formed lumen. Another example is to utilize multiple rows of anchors, clips, or sutures along the interface. Alternatively, bio-adhesives can be dispensed to buttress the tissue interface. In another variation, the tissue can be approximated in different configurations which effectively reduce or isolate the adhered tissue region.

Abstract: A surgical access device includes an access seal comprising an ultra gel elastomeric material formed of a mixture comprising a triblock copolymer and an oil. The access seal is adapted to be disposed relative to the abdominal wall. At least one access channel is formed through the elastomeric material between a proximal portion and a distal portion of the access seal. The access channel when operatively disposed forms at least a portion of a working channel between a location external to the abdominal wall and a location internal to the abdominal wall. The elastomeric material of the access seal is adapted to conform to a surface of an instrument inserted through the working channel to provide instrument access to the abdominal cavity while maintaining insufflation pressure in the abdominal cavity. The access channel is configured to self seal in the absence of any instrument extending through the access channel.

Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point.

Abstract: Apparatus and methods for positioning and securing anchors are disclosed herein. The anchors are adapted to be delivered and implanted into or upon tissue, particularly tissue within the gastrointestinal system of a patient. The anchor is adapted to slide uni-directionally over suture such that a tissue plication may be cinched between anchors. A locking mechanism either within the anchor itself of positioned proximally of the anchor may allow for the uni-directional translation while enabling the anchor to be locked onto the suture if the anchor is pulled, pushed, or otherwise urged in the opposite direction along the suture. This uni-directional anchor locking mechanism facilitates the cinching of the tissue plication between the anchors and it may be utilized in one or several anchors in cinching a tissue fold.

Abstract: An endoscopic tissue anchor deployment device includes a handle, an elongated shaft defining an internal lumen, and an end effector attached to the distal end of the elongated shaft. A tissue anchor catheter is removably inserted through the lumen of the elongated shaft, the catheter having a tissue anchor assembly that is deployable from its distal end. In some embodiments, the handle includes a pin and track assembly that defines a series of handle actuation steps corresponding to deployment steps for the deployment device end effector and the tissue anchor catheter. In some embodiments, the handle includes a catheter stop member that prevents movement of the tissue anchor catheter under certain circumstances, and a handle stop member that prevents actuation of the handle under certain circumstances.

Abstract: A surgical access device includes an access seal adapted to be disposed within an incision within an abdominal wall. The access seal has an external flange adapted to be disposed external to the abdominal wall and an internal flange adapted to be disposed internal to the abdominal wall. The access seal with flanges is formed monolithically. There are access channels through the access seal. The access channels span the thickness of the abdominal wall and form working channels between a location external to the abdominal wall and a location internal to the abdominal wall. The access seal is formed of an elastomeric material adapted to conform to a surface of an instrument inserted through the working channel to form an instrument seal along a length spanning the thickness of the abdominal wall. The elastomeric material is adapted to form an abdominal seal within the abdominal wall.

Abstract: A delivery catheter for a gastric reduction system includes an elongate torqueable tube, a needle translatably disposed within the torqueable tube, an anchor translatably disposed within the needle and a stabilization device for holding a distal tip of the torqueable tube against a tissue wall.

Abstract: Devices and methods for forming and securing tissue folds and elongated invaginations in gastric tissue are used as a treatment for obesity. In several embodiments, a plurality of tissue folds is formed along the greater curvature of the stomach using laparoscopic tissue anchor deployment devices. Additional embodiments include various combinations of tissue folds, elongated invaginations, and other reconfigurations of stomach tissue using laparoscopic devices or laparoscopic devices in combination with endoscopic devices.

Abstract: The present invention provides methods and apparatus for pleating at least a portion of a patient's body lumen, such as the colon. Pleating is achieved via relative motion between an endoscope and a flexible conduit having an engagement element configured to reversibly engage the body lumen.

Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Abstract: A method of reducing the cross-sectional area of a gastrointestinal lumen is provided wherein a delivery catheter having a needle, one or more anchors disposed within the needle and a suture coupled to each anchor is advanced into the gastrointestinal lumen, the needle extended through the tissue wall, and an anchor ejected from a distal tip of the needle through the tissue wall. The needle is then repositioned against an opposing tissue wall, another anchor deployed from the needle through the opposing tissue wall, and the tissue walls approximated by applying tension to the sutures.

Abstract: A delivery catheter for a gastric reduction system includes an elongate torqueable tube, a needle translatably disposed within the torqueable tube, an anchor translatably disposed within the needle and a stabilization device for holding a distal tip of the torqueable tube against a tissue wall.