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 rotateable to allow grasping, elevation and more complex manipulation of tissue.

Abstract: A surgical access device is adapted for performing laparoscopic surgical procedures with at least one instrument passing through the surgical access device and through an incision in the abdominal wall of a patient with the abdominal cavity pressurized with an insufflation gas. The surgical access device is adapted to provide instrument access to the abdominal cavity for surgical procedures while generally maintaining insufflation pressure in the abdominal cavity. The surgical access device comprises an access seal. The access seal comprises a material formed of a mixture comprising a triblock copolymer and an oil. The access seal is adapted to be disposed relative to the abdominal wall in an operative position. The material of the access seal is adapted to form a seal to generally maintain insufflation pressure within the abdominal cavity. At least one opening is formed through the material of the access seal between a proximal portion and a distal portion of the access seal.

Abstract: A surgical access device is adapted for performing laparoscopic surgical procedures with multiple instruments passing through the surgical access device and through a single incision in the abdominal wall of a patient with the abdominal cavity pressurized with an insufflation gas. The surgical access device is adapted to provide instrument access to the abdominal cavity for surgical procedures while generally maintaining insufflation pressure in the abdominal cavity. The surgical access device comprises an access pad. The access pad comprises a material formed of a mixture comprising a triblock copolymer, an oil, and a foaming agent. The access pad is adapted to be disposed within an incision within an abdominal wall. The access pad has an external flange and an internal flange integrally formed with the access pad.

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. Some embodiments of the systems include an elongated main body which is rigidizable and/or torque transmitting to improve manipulation through passageways in the body.

Abstract: A flexible surgery access and instrument management system includes a base unit and an insertion unit. The base unit provides a platform having a connection mechanism to which the insertion unit is attached. The insertion unit includes an elongated conduit having one or more tubes providing instrument passages, and a connection mechanism adapted to selectively couple with the mating connection mechanism provided on the base unit. The elongated conduit of the insertion unit is preferably steerable. One or more flexible instruments may be inserted through the tubes of the elongated conduit, with the proximal ends of the instruments being attached to the base unit such that the user is able to control and manipulate the instruments.

Abstract: Apparatus & methods for endoscopic suturing are described herein. A distal tip of the endoscopic device engages the tissue and then approximates the engaged tissue to form a tissue fold. A needle body positioned within a flexible catheter is deployed into or through the newly created tissue fold where it is then detached or released from the endoscopic device. The needle body has a length of suture which depends therefrom and can be used to secure the tissue fold. The entire endoscopic device or its tissue engaging assembly can then be rotated relative to the tissue fold while maintaining engagement with the tissue to maneuver the flexible catheter to the opposing side of the penetrated tissue fold. This procedure can be repeated any number of times to create an interrupted, continuous, or running suture to secure the 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 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 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: 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 & 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: Apparatus & methods for endoscopic suturing are described herein. A distal tip of the endoscopic device engages the tissue and then approximates the engaged tissue to form a tissue fold. A needle body positioned within a flexible catheter is deployed into or through the newly created tissue fold where it is then detached or released from the endoscopic device. The needle body has a length of suture which depends therefrom and can be used to secure the tissue fold. The entire endoscopic device or its tissue engaging assembly can then be rotated relative to the tissue fold while maintaining engagement with the tissue to maneuver the flexible catheter to the opposing side of the penetrated tissue fold. This procedure can be repeated any number of times to create an interrupted, continuous, or running suture to secure the tissue fold.

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: Endoscopic instrument management systems are described herein which allow one or more operators to manage multiple different instruments utilized in endoscopic procedures. In one aspect, 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. In another aspect, one or more plastically deformable instrument manifolds are provided to guide flexible endoscopic instruments into and through an endoscopic access device.

Abstract: Apparatus and methods are provided for mapping out endoluminal gastrointestinal surgery, including endoluminal gastric reduction. Mapping is achieved by locally marking the interior of the gastrointestinal lumen at specified locations. In some variations, mucosectomy and/or mucosal ablation are performed to map out endoluminal GI surgery, to facilitate direct endoluminal engagement of underlying muscularis tissue and/or to initiate a wound healing response. Specialized apparatus may be provided to achieve desired spacing and/or positioning of tissue markings, as well as to actually form the markings. Methods of using apparatus of the present invention are provided.

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: 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 & 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: 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.