Abstract: Devices and methods for laparoscopically repairing a hernia are described. In some embodiments, a laparoscopic instrument is used to deploy one or more tissue anchor assemblies into the edges of the fascia tissue surrounding or adjacent to the hernia defect. The tissue anchor assemblies are used to cause the fascia tissue to be approximated to facilitate the repair procedure, to improve healing, and to reduce the incidence of recurrence.

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.

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: 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: A catheter system comprising a guidewire, an endovascular catheter, and an aspiration catheter. The guidewire has an expandable occluder mounted on a distal end. The guidewire and the endovascular catheter are insertable into a lumen of the aspiration catheter. The aspiration catheter also includes infusion and aspiration lumen(s) and port(s). Methods of using the catheter system for treating a vascular lesion and removing embolic material during the procedure are also disclosed.

Abstract: Devices and methods for filtering blood. The devices generally comprise a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, and a means to actuate the structure. The methods generally include the steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel.

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: 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 defines 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: Devices and methods for filtering blood. The devices generally comprise a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, and a means to actuate the structure. The methods generally include the steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: Devices and methods for forming and securing tissue folds and elongated invaginations in gastric tissue are used as a treatment for obesity. In several embodiments, a plurality of tissue folds is formed along the greater curvature of the stomach using laparoscopic tissue anchor deployment devices. Additional embodiments include various combinations of tissue folds, elongated invaginations, and other reconfigurations of stomach tissue using laparoscopic devices or laparoscopic devices in combination with endoscopic devices.

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: A catheter system comprising a guidewire, an endovascular catheter, and an aspiration catheter. The guidewire has an expandable occluder mounted on a distal end. The guidewire and the endovascular catheter are insertable into a lumen of the aspiration catheter. The aspiration catheter also includes infusion and aspiration lumen(s) and port(s). Methods of using the catheter system for treating a vascular lesion and removing embolic material during the procedure are also disclosed.

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: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

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: A catheter system comprising a guidewire, an endovascular catheter, and an aspiration catheter. The guidewire has an expandable occluder mounted on a distal end. The guidewire and the endovascular catheter are insertable into a lumen of the aspiration catheter. The aspiration catheter also includes infusion and aspiration lumen(s) and port(s). Methods of using the catheter system for treating a vascular lesion and removing embolic material during the procedure are also disclosed.

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: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

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.