Abstract: Various packaging assemblies and methods for preserving sterility of a sensing device prior to insertion into a body cavity of a subject are described herein. Some implementations of a packaging assembly include: a bag comprising an interior, the bag at least partially comprising a transparent material; and a tray configured to be positioned within the interior of the bag and configured to retain and protect the sensing device, wherein the tray comprises an opening configured to allow a button of the sensing device to be engaged via a portion of the bag, thereby allowing the sensing device to be transitioned from a non-operational state to an operational state when retained by the tray and positioned within the interior of the bag. Such operational state can be one in which the sensing device can be wirelessly paired with a separate electronic device, for example, to enable wireless data transmission.

Abstract: Various packaging assemblies and methods for preserving sterility of a sensing device prior to insertion into a body cavity of a subject are described herein. Some implementations of a packaging assembly include: a bag comprising an interior, the bag at least partially comprising a transparent material; and a tray configured to be positioned within the interior of the bag and configured to retain and protect the sensing device, wherein the tray comprises an opening configured to allow a button of the sensing device to be engaged via a portion of the bag, thereby allowing the sensing device to be transitioned from a non-operational state to an operational state when retained by the tray and positioned within the interior of the bag. Such operational state can be one in which the sensing device can be wirelessly paired with a separate electronic device, for example, to enable wireless data transmission.

Abstract: Various packaging assemblies and methods for preserving sterility of a sensing device prior to insertion into a body cavity of a subject are described herein. Some implementations of a packaging assembly include: a bag comprising an interior, the bag at least partially comprising a transparent material; and a tray configured to be positioned within the interior of the bag and configured to retain and protect the sensing device, wherein the tray comprises an opening configured to allow a button of the sensing device to be engaged via a portion of the bag, thereby allowing the sensing device to be transitioned from a non-operational state to an operational state when retained by the tray and positioned within the interior of the bag. Such operational state can be one in which the sensing device can be wirelessly paired with a separate electronic device, for example, to enable wireless data transmission.

Abstract: Methods and apparatus for the endoluminal revision of previously performed obesity procedures which have failed are described. One or more endoluminal instruments may be advanced per-orally into the previously formed failed pouch where a number of different procedures can be performed. One or more tissue folds can be formed and secured to reduce the size of the pouch, or the stoma connecting the pouch to the intestinal tract can be reduced in size using endoluminally deployed tissue anchors. These procedures can be performed entirely from within the pouch lumen or upon the exterior surface of the pouch via transgastric entry of the instruments into the peritoneal cavity of a patient. Alternatively, the interior tissue within the pouch can be injured or sclerosed to shrink the pouch lumen. In another alternative, a length of the Roux limb can be shortened endoluminally to create a malabsorptive region.

Abstract: Methods and apparatus for the endoluminal revision of previously performed obesity procedures which have failed are described. One or more endoluminal instruments may be advanced per-orally into the previously formed failed pouch where a number of different procedures can be performed. One or more tissue folds can be formed and secured to reduce the size of the pouch, or the stoma connecting the pouch to the intestinal tract can be reduced in size using endoluminally deployed tissue anchors. These procedures can be performed entirely from within the pouch lumen or upon the exterior surface of the pouch via transgastric entry of the instruments into the peritoneal cavity of a patient. Alternatively, the interior tissue within the pouch can be injured or sclerosed to shrink the pouch lumen. In another alternative, a length of the Roux limb can be shortened endoluminally to create a malabsorptive region.

Abstract: Methods and apparatus for the endoluminal revision of previously performed obesity procedures which have failed are described. One or more endoluminal instruments may be advanced per-orally into the previously formed failed pouch where a number of different procedures can be performed. One or more tissue folds can be formed and secured to reduce the size of the pouch, or the stoma connecting the pouch to the intestinal tract can be reduced in size using endoluminally deployed tissue anchors. These procedures can be performed entirely from within the pouch lumen or upon the exterior surface of the pouch via transgastric entry of the instruments into the peritoneal cavity of a patient. Alternatively, the interior tissue within the pouch can be injured or sclerosed to shrink the pouch lumen. In another alternative, a length of the Roux limb can be shortened endoluminally to create a malabsorptive region.

Abstract: The present invention provides methods and apparatus for obtaining endoluminal access. An elongate body is configured for insertion within a body lumen, conduit, organ, orifice or passageway, the elongate body having a working axis and a distal region, and an articulating element disposed near the distal region, the articulating element configured to articulate off-axis from the working axis of the elongate body. Methods of using apparatus of the present invention are also provided.

Abstract: An ablation catheter system for capturing and removing necrotic tissue and thrombi generated during an ablative procedure is disclosed. The catheter typically includes an elongate member, a filtration assembly disposed within the distal region, and an ablation instrument at the distal end. Alternatively, the ablation instrument is carried on the distal end of an ablation catheter, which is disposed within a lumen of the catheter system. The catheter may further include an aspiration port and lumen. Methods of using the devices in preventing distal embolization during ablative procedures are disclosed.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include 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, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: Tissue anchors include a flat, broad, and large contact surface for engagement with a portion of tissue. Several embodiments of composite tissue anchors include a support element and an overlay element. Tissue anchor assemblies include two or more tissue anchors, a connector, and a cinching mechanism. In some embodiments, the tissue anchors included in the tissue anchor assemblies are of different types, sizes, and/or shapes.

Abstract: Methods and apparatus for the endoluminal revision of previously performed obesity procedures which have failed are described. One or more endoluminal instruments may be advanced per-orally into the previously formed failed pouch where a number of different procedures can be performed. One or more tissue folds can be formed and secured to reduce the size of the pouch, or the stoma connecting the pouch to the intestinal tract can be reduced in size using endoluminally deployed tissue anchors. These procedures can be performed entirely from within the pouch lumen or upon the exterior surface of the pouch via transgastric entry of the instruments into the peritoneal cavity of a patient. Alternatively, the interior tissue within the pouch can be injured or sclerosed to shrink the pouch lumen. In another alterative, a length of the Roux limb can be shortened endoluminally to create a malabsorptive region.

Abstract: Apparatus and methods are provided for cleaning a patient's colon in preparation for colonoscopy. A rigidizable overtube is described, as well as several variations of a colon-cleaning element configured for use with the overtube to clean the patient's colon. In one variation, the colon-cleaning element comprises a fluid jet. In another variation, the colon-cleaning element comprises a mechanical brush. Aspiration optionally may be provided for removing blockage material disrupted during colonic cleaning.

Abstract: Apparatus and methods for endoluminal advancement are described herein. A shape-lockable tissue anchoring assembly generally has an elongate body, a handle assembly, and an anchoring assembly positioned at or proximal to a distal tip of the elongate body. A distal portion of the elongate body may optionally be steerable or curvable. The anchoring assembly may include various expandable or projecting anchoring features to contact and retain tissue relative to the elongate body such that pleated tissue is temporarily immobile relative to the elongate body. This anchoring can be actuated simultaneously with or independently from shape-locking of elongate body. The anchoring assembly can be actuated simultaneously with the shape-locking of the elongate body. Alternatively, the steerable distal portion of the elongate body can be angled against the pleated tissue to retain it while the endoscope is advanced relative to the pleated tissue.

Abstract: Methods and apparatus for maintaining sterility during transluminal procedures are described. The sterility is achieved by making use of a membrane in either the form, e.g., of a sheath, cap or umbrella to keep the instruments (endoscopes, overtubes, etc.) sterile while being advanced through lumens in the body and into the various cavities. Methods, such as vacuum acquisition, mechanical tissue anchoring, etc., of the underlying tissue followed by incision of the tissue with, e.g., a needle knife, can be utilized to gain access to the various cavities. It is expected that this procedure will provide the desired level of sterility for transluminal procedures.

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: 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: 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: 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: An apparatus suitable for filtering emboli in an open surgical procedure. The apparatus comprises an elongated member having a distal region and a support hoop attached to the distal region. A blood permeable sac is affixed to the support hoop so that the support hoop forms a distally-facing mouth of the blood permeable sac. A guidewire is slideably attached to the elongated member. A delivery sheath is provided having a cavity for accepting the elongated member, support hoop and blood permeable sac, and a lumen extending through the cavity to permit the guidewire to pass therethrough. Methods of use are also described.