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: Removable apparatus and methods 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 tissue stabilizing members adapted to stabilize tissue therebetween, an engagement member slidably disposed through the stabilizing members and having a distal end adapted to engage tissue, and a delivery tube pivotable about the tissue stabilizing members. The tissue manipulation assembly optionally may be configured for removable attachment to an endoscope.

Abstract: Tissue manipulation and securement systems are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member and has a lower jaw member and an upper jaw member pivotably coupled to the lower jaw member. A reconfigurable launch tube is also pivotably coupled to the upper jaw member and is used to urge the jaw members from a low-profile configuration to an open configuration for receiving tissue. The tissue manipulation assembly may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly.

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: Tissue manipulation and securement systems are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member and has a lower jaw member and an upper jaw member pivotably coupled to the lower jaw member. A reconfigurable launch tube is also pivotably coupled to the upper jaw member and is used to urge the jaw members from a low-profile configuration to an open configuration for receiving tissue. The tissue manipulation assembly may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly.

Abstract: Multi-position tissue manipulation assemblies 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. One or all the articulation controls and functions can be integrated into a singular handle enclosure connectable to the tissue manipulation assembly via a rigid or flexible tubular body. A needle deployment mechanism may be positioned within the enclosure. Such a mechanism can have multiple positions adapted to lock and/or advance a needle assembly within the enclosure in a controlled manner as well as for deploying the anchor assembly.

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: 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: Removable apparatus and methods 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 tissue stabilizing members adapted to stabilize tissue therebetween, an engagement member slidably disposed through the stabilizing members and having a distal end adapted to engage tissue, and a delivery tube pivotable about the tissue stabilizing members. The tissue manipulation assembly optionally may be configured for removable attachment to an endoscope.

Abstract: Removable apparatus for manipulating and securing tissue within a treatment space are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have tissue stabilizing members adapted to stabilize tissue therebetween, an engagement member slidably disposed through the stabilizing members and having a distal end adapted to engage tissue, and a delivery tube pivotable about the tissue stabilizing members. The tissue manipulation assembly optionally may be configured for removable attachment to an endoscope.

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: 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 unidirectional 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: 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: 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 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 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.

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.

Abstract: Apparatus and methods are provided for placing and advancing a diagnostic of 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.

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.