Abstract: Flexible shaft systems having interchangeable end effectors are described herein. A shaft with a flexibility sufficient to allow advancement through a lumen of an endoscopic device has an interface at its distal end for engaging a removable end effector tool. The shaft and end effector tool are configured to enable endoluminal deployment through a patient, e.g., through the esophagus and into the stomach. The removable end effector tool may comprise any number of different tools, such as graspers, forceps, scissors, snares, needles, etc., each being interchangeable upon the flexible shaft distal end. Once a procedure is done within the patient, the flexible shaft may be withdrawn and another distal end effector tool may be interchanged. The new end effector tool and flexible shaft can then be reintroduced into the patient.

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: Methods and apparatus for obtaining endoluminal access are provided comprising a steerable endoluminal guide having a variable pivot for altering steering dynamics. In one variation, variable pivoting is achieved by advancing a member having a hard or substantially rigid section to various depths within a lumen of the guide. The hard section resists deformation, thereby reducing or precluding pivoting of the guide proximal of the distal-most depth of hard section insertion. In another variation, the guide comprises one or more pivot wires that terminate at a segment of the guide disposed proximal of the guide's distal outlet. In such a variation, the steering pivot of the guide may be altered by applying tension to at least one pivot wire, while concurrently applying tension to a steering wire that terminates more distally than the pivot wire, and that is radially offset from the pivot wire about the circumference of the guide.

Abstract: Systems, devices and methods for endoscopic procedures are provided involving accessing and manipulating tissues beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body which has one or more independently shape-lockable sections and a variety of instruments which are either built in to the main body or advanceable through lumens which extend through the main body. Such instruments may include scopes, suction instruments, aspiration instruments, tool arms, plicators, needles, graspers, and cutters, to name a few. The ability to steer and shapelock specific sections of the main body enables access to target locations which are typically challenging to reach and provides a stabilized platform to perform a desired procedure at the target location.

Abstract: Apparatus and methods for conveying or transmitting force or energy to a medical end effector coupled to a flexible or rigid shaft are described herein. One variation of such apparatus may be used to manipulate tissue and create a tissue fold and may generally comprise an elongate tubular member having an end effector disposed thereon. The end effector may comprise a tissue engagement member adapted to engage tissue, a first stabilizing member and a second stabilizing member positioned at the tubular member distal end, and a launch tube adapted to pivot about the first stabilizing member. Elements of the end effector may be actuable via various force transmission elements and/or mechanisms. Such force transmission elements preferably are integrated into and/or are actuable via a handle. The force transmission mechanisms may be utilized to actuate and/or transmit force to alternative medical end effectors coupled to flexible or rigid shafts.

Abstract: The attenuation or isolation of environmental parameters on a gastric lumen is described herein. Once tissue plications are formed into a gastric lumen or sleeve within a stomach, the newly formed lumen is subjected to a multitude of fluctuating stresses or pressure from food or fluids passing therethrough, from naturally-occurring contractions, and/or from changes in pH levels from caustic stomach acids and hormones. The tissue interface between these plications can be isolated from such environmental fluctuations, or the fluctuations can be attenuated, by a number of methods. One example is to place a gastric stent or sleeve within the newly formed lumen. Another example is to utilize multiple rows of anchors, clips, or sutures along the interface. Alternatively, bio-adhesives can be dispensed to buttress the tissue interface. In another variation, the tissue can be approximated in different configurations which effectively reduce or isolate the adhered tissue region.

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: 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 pleating at least a portion of a patient's body lumen, such as the colon. Pleating is achieved via relative motion between an endoscope and a flexible conduit having an engagement element configured to reversibly engage the body lumen.

Abstract: Apparatus and methods are provided for controlling pressurization of a body cavity by controlling the rate and magnitude of pressurization during insufflation and/or exsufflation. In one variation, a pump may be used to either draw suction or to pressurize a body cavity. The pump may be connected to a controller that controls one or more regulators and/or valves for regulating pressurization. The controller preferably is programmable to allow a medical practitioner to input and/or rapidly alter desired pressurization parameters. In another variation, one or more pumps may be provided to simultaneously and independently control pressurization of multiple body cavities, such as a patient's stomach and peritoneal cavity.

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: Disposable shapelocking systems are disclosed herein. A shapelock assembly generally comprises an elongate body defining at least one lumen therethrough for advancement of an endoscope or other endoscopic instruments therethrough. A handle assembly can be actuated to compress nested links against one another to transition the elongate body from a flexible state to a rigid shape-locked state. One or more of the nested links can be made from a particular thermoplastic either alone or in combination with one or more reinforcing structures. Such structures can include a reinforcing ring integrated with the link on an inner, outer, or lower surface of the link. Alternatively, the link can be coated or layered to enhance its strength. Additionally, different portions of the shapelock body can be made from different types of links depending upon the loads imparted upon the various portions of the shapelock body.

Abstract: Methods and apparatus for performing malabsorptive bypass procedures within a patient's gastrointestinal lumen are described comprising, for example, gastroenterostomy procedures that are preferably performed in an endoscopic or laparoscopic fashion. Anastomosis between the patient's stomach and intestine allows food to bypass at least a portion of the patient's stomach and/or intestine, thereby providing a malabsorptive region. The malabsorptive procedure may be accompanied by additional procedures, for example, pyloric occlusion, pyloroplasty, gastroplasty, gastric tissue destruction and/or intestinal pleating.

Abstract: A multi-barbed apparatus is provided, and methods of use, for penetrating two sides of a wound and holding the edges in apposition. The apparatus may be inserted within a wound or underneath the skin, and mechanically adheres the two sides of the wound together. The apparatus includes a biocompatible substrate carrying a multiplicity of tissue penetrating barbs on a least one side thereof, and may be formed as a rigid or flexible sheet, tube or other shape.

Abstract: Apparatus and methods are provided for achieving prolonged maintenance of gastrointestinal (“GI”) tissue folds. The apparatus and methods are adapted to form, secure, approximate and promote healing of tissue folds. Such healing may comprise remodeling the tissue folds along region(s) of opposing tissue contact to facilitate prolonged maintenance of the folds. In one variation, the apparatus and methods may be utilized to achieve gastric reduction. The apparatus may be provided as a system of tools.

Abstract: A manipulatable grasping needle is described herein. A piercing and grasping assembly generally comprises a needle body, which is optionally hollow, having a piercing tip and a grasping arm positioned proximally of the tip, wherein the grasping arm is adapted to project from the needle body and releasably retain a length of suture. Alternatively, opposing jaws can form a singular piercing tip when the jaws are closed. The assembly is positioned at the distal end of an elongate member which can be rigid or flexible for advancement through an endoscopic device. The elongate member can also comprise one or more articulatable sections to enable manipulation of the assembly into various shapes to facilitate suture and tissue manipulation. Moreover, either the needle body or grasping arm can define a notch for receiving suture material. A hooking member can also be provided to facilitate suture retrieval when grasping suture.

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: Systems 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: 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.