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: 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: 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: 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: 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: 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 surgical access device includes a single valve that forms a seal with the body wall and provides an access channel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal with instruments having a full range of instrument diameter. The valve can include a gel and preferably an ultragel comprised of an elastomer and an oil providing elongation greater than 1000 percent and durometer less than 5 Shore A. The single valve can be used as a hand port where the instrument comprises the arm of a surgeon, thereby providing hand access into the cavity. A method for making the surgical access device includes the combining of a gelling agent with an oil, preferably in a molding process. A method for using the device includes steps for creating an opening with the instrument.

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: A surgical wound retractor is adapted to dilate a wound stretchable to a desired diameter, the retractor includes a first ring having a diameter greater than that desired for the wound and being adapted for disposition interiorly of the wound. A second ring has a diameter greater than that desired for the wound and is adapted for disposition exteriorly of the wound. A plurality of retraction elements are disposed in a generally cylindrical relationship to each other, between the first ring and the second ring. These elements extend through the wound to exert a radial retraction force on the wound which is dependent on the distance separating the first ring and the second ring. Retraction elements, both distensible and non-distensible are contemplated with appropriate attachment means at the rings to provide for variations in the retraction force. With a suitable retraction sleeve, a third ring can be provided to form a circumferential retainer to vary the retraction force.

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.

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: 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: 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 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: 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: 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.