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 This allows the anchor assembly to be advanced distally as well as withdrawn proximally within a deployment sheath while avoiding inadvertently ejecting an anchor.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: 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 rotatable to allow grasping, elevation and more complex manipulation of tissue.

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 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.

Abstract: An articulatable, steerable tool guide includes a maneuverable head subassembly, a flexible or rigid insertion tube subassembly, and a handle subassembly. The tool guide defines at least one inner lumen extending through the length of the tool guide, with each such lumen being adapted to receive a flexible endoscopic medical device.

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: Methods for performing gastroplasty include reducing the effective volume or cross-sectional area of the stomach via approximation of gastric tissue. Such reduction preferably is achieved endoluminally, either with or without laparoscopic ports. In one variation, a sleeve, pouch, Magenstrasse and Mill, Vertical Banded Gastroplasty (“VBG”), etc., is formed within the stomach by approximating opposing anterior and posterior segments or ridges of the stomach wall at locations inferior to the gastroesophageal junction. In another variation, opposing walls of the stomach are approximated at a plurality of substantially random locations to reduce an effective volume of the stomach. In yet another variation, both a sleeve and random approximations are formed, the random approximations preferably disposed in a portion of the stomach excluded by the sleeve. In still another variation, opposing walls of the stomach are approximated over significant lengths at random or specified locations.

Abstract: Flexible, steerable, endoscopic instruments include a handle, a flexible shaft, and an end effector. The handle includes an actuator for controlling the end effector. The handle also includes a steering mechanism for steering the endoscopic instrument. The steering mechanism includes one or more tensioning members configured to increase or decrease a tension force on one or more steering wires that are attached to one or more steerable portions of the flexible shaft.

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 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 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 for performing gastroplasty include reducing the effective volume or cross-sectional area of the stomach via approximation of gastric tissue. Such reduction preferably is achieved endoluminally, either with or without laparoscopic ports. In one variation, a sleeve, pouch, Magenstrasse and Mill, Vertical Banded Gastroplasty (“VBG”), etc.,is formed within the stomach by approximating opposing anterior and posterior segments or ridges of the stomach wall at locations inferior to the gastroesophageal junction. In another variation, opposing walls of the stomach are approximated at a plurality of substantially random locations to reduce an effective volume of the stomach. In yet another variation, both a sleeve and random approximations are formed, the random approximations preferably disposed in a portion of the stomach excluded by the sleeve. In still another variation, opposing walls of the stomach are approximated over significant lengths at random or specified locations.

Abstract: A surgical access device includes a single valve forming a seal with the body wall and providing an access channel into a body cavity. The valve has properties for creating a zero-seal in the absence of an instrument and an instrument seal with instruments. The valve can include a gel comprised of an elastomer and 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. A method for making the surgical access device includes combining a gelling agent with oil, preferably in a molding process. A method for using the device includes creating an opening with the instrument. An organ can be removed from the body cavity through the single valve to create an organ seal while the organ is addressed externally of the body cavity.

Abstract: Endoluminal instrument management systems are described herein which allow one or more operators to manage multiple different instruments utilized in endoluminal procedures. Responsibility for instrumentation management between one or more operators may be configured such that a first set of instruments is controlled by a primary operator and a second set of instruments is controlled by a secondary operator. The division of instrumentation may be facilitated by the use of separated instrumentation platforms or a single platform which separates each instrument for use by the primary operator. Such platforms may be configured as trays, instrument support arms, multi-instrument channels, as well as rigidized portions of instruments to facilitate its handling, among others.

Abstract: A surgical access device includes a single valve forming a seal with the body wall and providing an access channel into a body cavity. The valve has properties for creating a zero-seal in the absence of an instrument and an instrument seal with instruments. The valve can include a gel comprised of an elastomer and 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. A method for making the surgical access device includes combining a gelling agent with oil, preferably in a molding process. A method for using the device includes creating an opening with the instrument. An organ can be removed from the body cavity through the single valve to create an organ seal while the organ is addressed externally of the body cavity.

Abstract: An endoscopic system includes a sheath having a flexible sheath body. A tip is attached to a distal end of the sheath body. A handle is attached to the proximal end of the sheath body. A steerable section may be provided in the sheath adjacent to the tip. Steering controls may then be provided on the handle for steering the steerable section. Lumens extend from the tip to the handle. The distal end of each lumen is sealed to the tip. Bodily fluids can only enter into the lumens and not other areas within the sheath. A shapelock assembly has an elongated hollow body positionable within the sheath body. The shapelock body may be switched between generally rigid and flexible conditions. The sheath provides a sterile barrier around the shapelock body. The shapelock assembly can be readily reused and the sheath may be disposable.

Abstract: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue grasping member attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the tissue grasping member. In an embodiment, the tissue grasping member includes a pair of jaws configured to open to an included angle between the jaws of 180 degrees or more. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.

Abstract: An endoscopic system includes a sheath having a flexible sheath body. A tip is attached to a distal end of the sheath body. A handle is attached to the proximal end of the sheath body. A steerable section may be provided in the sheath adjacent to the tip. Steering controls may then be provided on the handle for steering the steerable section. Lumens extend from the tip to the handle. The distal end of each lumen is sealed to the tip. Bodily fluids can only enter into the lumens and not other areas within the sheath. A shapelock assembly has an elongated hollow body positionable within the sheath body. The shapelock body may be switched between generally rigid and flexible conditions. The sheath provides a sterile barrier around the shapelock body. The shapelock assembly can be readily reused and the sheath may be disposable.

Abstract: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue penetrating and grasping member attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the tissue penetrating and grasping member. In an embodiment, the tissue penetrating and grasping member includes a rigid penetrating member that is rotatably attached to the distal end of the elongated shaft. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.

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.