Abstract: Methods and apparatus are provided for diagnosing and treating digestive or other organs (as well as other parts of the body) endoluminally and transluminally, via instruments passed into the GI tract per-orally and/or per-anally. The instruments may, for example, pass transluminally out of the stomach and/or the colon through a breach formed therein in order to conduct diagnostic or therapeutic procedures, such as gastroenterostomy.

Abstract: Apparatus & 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: Methods and apparatus for performing endoluminal procedures are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Multiple 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: Apparatus and methods for transgastric tissue manipulation are described herein. Procedures are performed transgastrically through a trocar or insert, e.g., to create tissue plications and approximating those plications towards one another for accomplishing gastroplasty procedures. The trocar is positioned through the abdominal wall of the patient and into the stomach. A multi-lumen insertion tool is positioned within the trocar and comprises one or several channels, e.g., two, three, or more channels as practicable, through the single insertion tool. Each of the channels is aligned and individually sealable with a reversible seal which allows for insertion or removal of a tool therethrough without comprising sealing of the entire trocar or port. A proximal section of the shafts comprise a flexible section to allow for the flexing of each respective control handle away from one another such that the surgeon can manipulate the tools without interference between the handles.

Abstract: 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 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: Self-locking 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: Methods and apparatus for grasping a suture and cinching and/or locking 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 suture of the tissue anchor. With suture engaged, the grasper may be withdrawn within the tube, such that the resilient member again obstructs the lumen of the tube. Continued retraction of the grasper relative to the tube and anchor may act to cinch the anchor via interaction between a cinching/locking mechanism of the anchor and the obstructing resilient member. In an alternative variation, a snare device is provided comprising a resilient wire loop that coacts with an element of the snare device or of the tissue anchor for grasping and cinching the tissue anchor.

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: A system for treating gastroesophageal reflux disease (GERD) is disclosed herein. A variety of tools, such as a shape-lockable endoscopic device, can be advanced trans-esophageally and into the stomach or through the stomach wall to access regions of the tissue in and around the gastroesophageal junction. Utilizing expandable tissue anchors, the angle of Hiss can be reconfigured by deploying the anchors within the esophagus and fundus and approximating the two. Alternatively, the esophagus can be lengthened by approximating tissue from within the stomach to follow the lesser curve of the stomach. Alternatively, one or more tissue folds can be formed within or adjacent to the GEJ to form a barrier to refluxing stomach contents.

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: Needle assemblies for tissue manipulation 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. A needle deployment assembly is deployable through the tissue manipulation assembly via a handle assembly, through the tubular member, and into or through tissue. An elongate pusher is translationally disposed within a sheath of the needle deployment assembly and can be urged distally for deploying an anchor assembly from the sheath distal end. The anchor assembly is positioned distally of the pusher within the sheath.

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 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 or liner, and a distal region having an atraumatic tip. The sheath/liner may be disposable to permit reuse of the overtube. Loading devices may be provided for disposing the sheath/liner about the overtube. 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 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 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: Apparatus and methods for rapid deployment of tissue anchors 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 pivotably coupled to the upper jaw member and is used to urge the jaw members from a low-profile configuration to an open configuration. A needle assembly can be advanced through the launch tube across tissue received between the jaw members of the tissue manipulation assembly. Tissue anchors can be advanced through the needle assembly for securing received tissue. The tissue anchors can be positioned within a reloadable chamber of a control handle disposed outside the patient, then advanced through the needle 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: 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: 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.