Abstract: Devices and methods for forming and securing tissue folds and elongated invaginations in stomach tissue are used as a treatment for obesity. In a first embodiment, a plurality of tissue folds is formed in the fundus region of the stomach. In a second embodiment, one or more elongated invaginations is formed in the body region of the stomach. In a third embodiment, a plurality of tissue folds is formed in the fundus region of the stomach and one or more elongated invaginations is formed in the body region of the stomach. Additional embodiments include various combinations of tissue folds, elongated invaginations, and other reconfigurations of stomach tissue.

Abstract: An articulatable, steerable tool guide includes a maneuverable head subassembly, a flexible or rigid insertion tube subassembly, and a handle subassembly. The tool guide defines at least one inner lumen extending through the length of the tool guide, with each such lumen being adapted to receive a flexible endoscopic medical device.

Abstract: Interlocking tissue anchor apparatus and methods 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. Anchor assemblies can be delivered via the tissue manipulation assembly into or through the tissue. The anchors can incorporate various temporary interlocking features or spacing elements between one another to ensure that an anchor is not prematurely ejected from the needle assembly. This allows the anchor assembly to be advanced distally as well as withdrawn proximally within a deployment sheath while avoiding inadvertently ejecting an anchor.

Abstract: An endoscopic system includes a sheath having a flexible sheath body. A tip is attached to a distal end of the sheath body. A handle is attached to the proximal end of the sheath body. A steerable section may be provided in the sheath adjacent to the tip. Steering controls may then be provided on the handle for steering the steerable section. Lumens extend from the tip to the handle. The distal end of each lumen is sealed to the tip. Bodily fluids can only enter into the lumens and not other areas within the sheath. In some embodiments, a shapelock assembly has an elongated hollow body positionable within the sheath body. The shapelock body may be switched between generally rigid and flexible conditions The sheath provides a sterile barrier around the shapelock body. The shapelock assembly can be readily reused and the sheath may be disposable. In other embodiments, the flexible sheath has a composite construction that provides improved torque transmission capabilities.

Abstract: Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another. Once the edges are brought towards one another, they may be joined such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner. Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another.

Abstract: Methods for performing gastroplasty include reducing the effective volume or cross-sectional area of the stomach via approximation of gastric tissue. Such reduction preferably is achieved endoluminally, either with or without laparoscopic ports. In one variation, a sleeve, pouch, Magenstrasse and Mill, Vertical Banded Gastroplasty (“VBG”), etc., is formed within the stomach by approximating opposing anterior and posterior segments or ridges of the stomach wall at locations inferior to the gastroesophageal junction. In another variation, opposing walls of the stomach are approximated at a plurality of substantially random locations to reduce an effective volume of the stomach. In yet another variation, both a sleeve and random approximations are formed, the random approximations preferably disposed in a portion of the stomach excluded by the sleeve. In still another variation, opposing walls of the stomach are approximated over significant lengths at random or specified locations.

Abstract: Apparatus and methods are provided for performing mucosectomy, such as to map out gastrointestinal surgery, including endoluminal gastric reduction. In one variation, the apparatus comprises a separating element and an integrated resection element. In one variation, the apparatus is configured to simultaneously separate mucosal tissue from underlying muscularis tissue and to resect the separated mucosal tissue. Methods of using the apparatus are provided.

Abstract: Flexible, steerable, endoscopic instruments include a handle, a flexible shaft, and an end effector. The handle includes an actuator for controlling the end effector. The handle also includes a steering mechanism for steering the endoscopic instrument. The steering mechanism includes one or more tensioning members configured to increase or decrease a tension force on one or more steering wires that are attached to one or more steerable portions of the flexible shaft.

Abstract: A ligature delivery device includes a control member, an elongated shaft, and an end effector attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the end effector. In several embodiments, the end effector includes a reverse grasping mechanism. Several embodiments of ligature devices are adapted to be deployed endoscopically and/or translumenally using the reverse-grasping delivery device.

Abstract: Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another. Once the edges are brought towards one another, they may be joined such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner. Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another.

Abstract: Methods for performing gastroplasty include reducing the effective volume or cross-sectional area of the stomach via approximation of gastric tissue. Such reduction preferably is achieved endoluminally, either with or without laparoscopic ports. In one variation, a sleeve, pouch, Magenstrasse and Mill, Vertical Banded Gastroplasty (“VBG”), etc.,is formed within the stomach by approximating opposing anterior and posterior segments or ridges of the stomach wall at locations inferior to the gastroesophageal junction. In another variation, opposing walls of the stomach are approximated at a plurality of substantially random locations to reduce an effective volume of the stomach. In yet another variation, both a sleeve and random approximations are formed, the random approximations preferably disposed in a portion of the stomach excluded by the sleeve. In still another variation, opposing walls of the stomach are approximated over significant lengths at random or specified locations.

Abstract: Endoluminal instrument management systems are described herein which allow one or more operators to manage multiple different instruments utilized in endoluminal procedures. Responsibility for instrumentation management between one or more operators may be configured such that a first set of instruments is controlled by a primary operator and a second set of instruments is controlled by a secondary operator. The division of instrumentation may be facilitated by the use of separated instrumentation platforms or a single platform which separates each instrument for use by the primary operator. Such platforms may be configured as trays, instrument support arms, multi-instrument channels, as well as rigidized portions of instruments to facilitate its handling, among others.

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: An endoscopic system includes a sheath having a flexible sheath body. A tip is attached to a distal end of the sheath body. A handle is attached to the proximal end of the sheath body. A steerable section may be provided in the sheath adjacent to the tip. Steering controls may then be provided on the handle for steering the steerable section. Lumens extend from the tip to the handle. The distal end of each lumen is sealed to the tip. Bodily fluids can only enter into the lumens and not other areas within the sheath. A shapelock assembly has an elongated hollow body positionable within the sheath body. The shapelock body may be switched between generally rigid and flexible conditions. The sheath provides a sterile barrier around the shapelock body. The shapelock assembly can be readily reused and the sheath may be disposable.

Abstract: An endoscopic system includes a sheath having a flexible sheath body. A tip is attached to a distal end of the sheath body. A handle is attached to the proximal end of the sheath body. A steerable section may be provided in the sheath adjacent to the tip. Steering controls may then be provided on the handle for steering the steerable section. Lumens extend from the tip to the handle. The distal end of each lumen is sealed to the tip. Bodily fluids can only enter into the lumens and not other areas within the sheath. A shapelock assembly has an elongated hollow body positionable within the sheath body. The shapelock body may be switched between generally rigid and flexible conditions. The sheath provides a sterile barrier around the shapelock body. The shapelock assembly can be readily reused and the sheath may be disposable.

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: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue penetrating and 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 penetrating and grasping member. In an embodiment, the tissue penetrating and grasping member includes a rigid penetrating member that is rotatably attached to the distal end of the elongated shaft. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.

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: Methods and apparatus for controlled grasping and cinching or locking of a tissue anchor are provided. In one variation, a tube is provided having a lumen and a resilient member that obstructs the lumen. A grasper may be advanced coaxially through the lumen, such that it reversibly displaces the resilient member and extends beyond the lumen's outlet to engage an element of the tissue anchor. The grasper then may be retracted within the tube, such that the resilient member again obstructs the lumen of the tube. Continued retraction of the grasper may act to cinch the anchor, for example, via interaction between the anchor and the obstructing resilient member. During cinching, a cinching mechanism of the anchor optionally may be positioned at least partially within the tube to enhance lateral stability. Furthermore, feedback indicative of a degree of cinching or locking may be provided during cinching.