Abstract: Apparatus and methods optimize anchoring force in securing tissue folds. Over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable designs 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.

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: Methods and apparatus for the endoluminal revision of previously performed obesity procedures which have failed are described. One or more endoluminal instruments may be advanced per-orally into the previously formed failed pouch where a number of different procedures can be performed. One or more tissue folds can be formed and secured to reduce the size of the pouch, or the stoma connecting the pouch to the intestinal tract can be reduced in size using endoluminally deployed tissue anchors. These procedures can be performed entirely from within the pouch lumen or upon the exterior surface of the pouch via transgastric entry of the instruments into the peritoneal cavity of a patient. Alternatively, the interior tissue within the pouch can be injured or sclerosed to shrink the pouch lumen. In another alternative, a length of the Roux limb can be shortened endoluminally to create a malabsorptive region.

Abstract: Devices and methods for forming and securing tissue folds, elongated invaginations, and tissue appositions 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 are formed in the body region and/or antrum 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 and/or antrum of the stomach. In other embodiments, a plurality of tissue folds is formed in the fundus region of the stomach and one or more tissue appositions are formed in the body region and/or antrum of the stomach. Additional embodiments include various combinations of tissue folds, elongated invaginations, tissue appositions, and other reconfigurations of stomach tissue.

Abstract: An endoluminal surgical instrument has first and second steering controls on a handle. A flexible shaft attached to the handle has a distal steerable end including a first link and a second link separated by a plurality of intermediate links. First and second steering elements, such as pairs of steering wires, are linked to first and second steering controls and to the first and second links. One or more of the links is pivotable through an angle of at least 30 degrees relative to an adjoining link. The set back position of the second steering elements from the first steering elements, and the pivoting capability of the links allows the steerable end to be steered into a small bend radius. This makes the instrument highly maneuverable for use in endoluminal surgery, such as incision-less surgery of the stomach.

Abstract: Transgastric abdominal access methods and apparatus are described herein. A shape-lockable elongate body can be advanced endoluminally in a flexible state into the stomach, where an opening is created through the stomach wall. The opening can be created endoluminally or by incising instruments placed through the abdominal wall. The elongate body can be transitioned to a rigid state prior to, during, or after advancement into the patient and is passed through the opening into the peritoneal cavity. A dilation balloon can be positioned simultaneously within the elongate body and within the tissue opening such that the elongate body can be advanced through the tissue opening. A flexible needle catheter can also be delivered through the elongate body or an endoscope to provide for insufflation prior to cutting or piercing through the stomach wall. Also, tissue closure devices and methods to close the opening created through the stomach wall.

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: Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which 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. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically by applying thermal energy through at least one suture cutting element disposed along the deployment assembly.

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: 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: 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 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: A surgical method for treating obesity by reducing the size and/or function of the stomach includes forming at least two plications or tissue folds in tissue of a patient using anchor assemblies having a loop. The plications are then optionally allowed to heal. A loop suture or wire is threaded through the loops. The loop suture is then tensioned to draw the plications towards each other. The loop suture is then secured via a knot or a cinch. When the method is performed in the stomach for treatment of obesity, forming the plications reduces the volume of the stomach. Drawing the plications together creates a contracted tissue area which further reduces the volume of the stomach. Additional plications may also be formed and drawn together with the same loop suture, or with a different loop suture.

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: 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: Apparatus and methods optimize anchoring force in securing tissue folds. Over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable designs 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.

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: 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 define 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: 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: Methods and apparatus for off-axis visualization 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.