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.

Abstract: Linear anchors for anchoring to tissue 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, which may be a ribbon, flattened wire, etc., is adapted to be delivered in an elongate straightened configuration through or against the tissue and then compressed along a longitudinal direction such that a tissue plication may be cinched between anchors. The elongate anchor defines a plurality of holes along its length in any number of patterns. A length of suture is routed through these holes such that tensioning the suture urges the elongate anchor to compress into its expanded anchoring configuration. A locking mechanism facilitates the cinching of the anchor against the tissue surface.

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: Apparatus and methods are provided for placing and advancing a diagnostic or therapeutic instrument in a hollow body organ of a tortuous or unsupported anatomy, comprising a handle, an overtube disposed within a hydrophilic sheath, and a distal region having an atraumatic tip. The overtube may be removable from the handle, and have a longitudinal axis disposed at an angle relative to the handle. The sheath may be disposable to permit reuse of the overtube. Fail-safe tensioning mechanisms may be provided to selectively stiffen the overtube to reduce distension of the organ caused by advancement of the diagnostic or therapeutic instrument. The fail-safe tensioning mechanisms reduce the risk of reconfiguration of the overtube in the event that the tension system fails, and, in one embodiment, rigidizes the overtube without substantial proximal movement of the distal region.

Abstract: Apparatus and methods are provided for placing and advancing a diagnostic or therapeutic instrument in a hollow body organ of a tortuous or unsupported anatomy, comprising a handle, an overtube disposed within a hydrophilic sheath, and a distal region having an atraumatic tip. The overtube may be removable from the handle, and have a longitudinal axis disposed at an angle relative to the handle. The sheath may be disposable to permit reuse of the overtube. Fail-safe tensioning mechanisms may be provided to selectively stiffen the overtube to reduce distension of the organ caused by advancement of the diagnostic or therapeutic instrument. The fail-safe tensioning mechanisms reduce the risk of reconfiguration of the overtube in the event that the tension system fails, and, in one embodiment, rigidizes the overtube without substantial proximal movement of the distal region.

Abstract: The present invention provides methods and apparatus for obtaining endoluminal access. An elongate body is configured for insertion within a body lumen, conduit, organ, orifice or passageway, the elongate body having a working axis and a distal region, and an articulating element disposed near the distal region, the articulating element configured to articulate off-axis from the working axis of the elongate body. Methods of using apparatus of the present invention are also provided.

Abstract: The present invention provides methods and apparatus for obtaining endoluminal access. An elongate body is configured for insertion within a body lumen, conduit, organ, orifice, passageway or cavity, the elongate body having a working axis and a distal region, and an articulating element disposed near the distal region, the articulating element configured to articulate off-axis from the working axis of the elongate body. The elongate may achieve access in an endoluminal or a laparoscopic fashion. Methods of using the apparatus are also provided.

Abstract: Apparatus and methods are provided for mapping out endoluminal gastrointestinal surgery, including endoluminal gastric reduction. Mapping is achieved by locally marking the interior of the gastrointestinal lumen at specified locations. In a first embodiment, the surgical map comprises localized RF scarring or mucosal ablation. In an alternative embodiment, the map comprises pegs. In another alternative embodiment, the map comprises dye and/or spheres injected into at least the submucosa. As a still further alternative, the map may comprise the shaft of an endoluminal surgical tool having specified dimensions and/or color-coding, etc. In another alternative embodiment, the map may be formed from surgical mesh. In one preferred embodiment, placement of the map is accurately achieved by approximating the interior of the stomach with an endoluminal support via suction ports and/or via an inflatable member disposed along the support. Methods of using apparatus of the present invention are provided.

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: Apparatus and methods are provided for mapping out endoluminal gastrointestinal surgery, including endoluminal gastric reduction. Mapping is achieved by locally marking the interior of the gastrointestinal lumen at specified locations. In some variations, mucosectomy and/or mucosal ablation are performed to map out endoluminal GI surgery, to facilitate direct endoluminal engagement of underlying muscularis tissue and/or to initiate a wound healing response. Specialized apparatus may be provided to achieve desired spacing and/or positioning of tissue markings, as well as to actually form the markings. Methods of using apparatus of the present invention are provided.

Abstract: Apparatus and methods are provided for placing and advancing a diagnostic or therapeutic instrument in a hollow body organ of a tortuous or unsupported anatomy, comprising a handle, an overtube disposed within a hydrophilic sheath, and a distal region having an atraumatic tip. The overtube may be removable from the handle, and have a longitudinal axis disposed at an angle relative to the handle. The sheath may be disposable to permit reuse of the overtube. Fail-safe tensioning mechanisms may be provided to selectively stiffen the overtube to reduce distension of the organ caused by advancement of the diagnostic or therapeutic instrument. The fail-safe tensioning mechanisms reduce the risk of reconfiguration of the overtube in the event that the tension system fails, and, in one embodiment, rigidizes the overtube without substantial proximal movement of the distal region.

Abstract: Apparatus and methods are provided for creating and regulating a gastric stoma by intraluminally reducing or partitioning a local cross-sectional area of the stomach, thereby inducing weight loss in obese patients. Various embodiments of stomas in accordance with the present invention are provided, as well as various regulation mechanisms for controlling or adjusting the size of the stoma.

Abstract: Apparatus & methods for endoscopic suturing are described herein. A distal tip of the endoscopic device engages the tissue and then approximates the engaged tissue to form a tissue fold. A needle body positioned within a flexible catheter is deployed into or through the newly created tissue fold where it is then detached or released from the endoscopic device. The needle body has a length of suture which depends therefrom and can be used to secure the tissue fold. The entire endoscopic device or its tissue engaging assembly can then be rotated relative to the tissue fold while maintaining engagement with the tissue to maneuver the flexible catheter to the opposing side of the penetrated tissue fold. This procedure can be repeated any number of times to create an interrupted, continuous, or running suture to secure the tissue fold.

Abstract: Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough and at least one steerable tool arm which extends from the distal end of the main body. In preferred embodiments, the system includes two tool arms, each arm steerable to form a curve laterally outward which then bends laterally inward so that the arms form an angular shape. In addition, end effectors extend from the distal ends of each tool arm for use in manipulation of tissue. The angular shape brings the end effectors together in view of the scope for cooperative movements which are continuously visible by the surgeon. In addition, the tool arms may be steerable in any additional direction and may be rotateable to allow grasping, elevation and more complex manipulation of tissue.

Abstract: Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough and at least one steerable tool arm which extends from the distal end of the main body. In preferred embodiments, the system includes two tool arms, each arm steerable to form a curve laterally outward which then bends laterally inward so that the arms form an angular shape. In addition, end effectors extend from the distal ends of each tool arm for use in manipulation of tissue. The angular shape brings the end effectors together in view of the scope for cooperative movements which are continuously visible by the surgeon. In addition, the tool arms may be steerable in any additional direction and may be rotateable to allow grasping, elevation and more complex manipulation of tissue.

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: Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough and at least one steerable tool arm which extends from the distal end of the main body. In preferred embodiments, the system includes two tool arms, each arm steerable to form a curve laterally outward which then bends laterally inward so that the arms form an angular shape. In addition, end effectors extend from the distal ends of each tool arm for use in manipulation of tissue. The angular shape brings the end effectors together in view of the scope for cooperative movements which are continuously visible by the surgeon. In addition, the tool arms may be steerable in any additional direction and may be rotateable to allow grasping, elevation and more complex manipulation of tissue.

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: Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough and at least one steerable tool arm which extends from the distal end of the main body. In preferred embodiments, the system includes two tool arms, each arm steerable to form a curve laterally outward which then bends laterally inward so that the arms form an angular shape. In addition, end effectors extend from the distal ends of each tool arm for use in manipulation of tissue. The angular shape brings the end effectors together in view of the scope for cooperative movements which are continuously visible by the surgeon. In addition, the tool arms may be steerable in any additional direction and may be rotateable to allow grasping, elevation and more complex manipulation of tissue.

Abstract: Apparatus and methods are provided for placing and advancing a diagnostic or therapeutic instrument in a hollow body organ of a tortuous or unsupported anatomy, comprising a handle, an overtube, a distal region having an atraumatic tip. The overtube may be removable from the handle, and have a longitudinal axis disposed at an angle relative to the handle. The overtube may be selectively stiffened to reduce distension of the organ caused by advancement of the diagnostic or therapeutic instrument. The distal region permits passive steering of the overtube caused by deflection of the diagnostic or therapeutic instrument while the atraumatic tip prevents the wall of the organ from becoming caught or pinched during manipulation of the diagnostic or therapeutic instrument.