Abstract: A device carries a use monitoring element that possesses a state or condition that changes in response to use of the device and that is sensed when the device is presented for use. Reuse of the device is not permitted, if the use monitoring element indicates a prior use.

Abstract: A sphincter tissue region is treated using a support structure sized for advancement into the anal canal. At least one electrode is carried by the structure. A mechanism is coupled to the electrode to move the electrode between a first position retracted in the support structure and a second position extended from the support structure through surface tissue to penetrate a subsurface tissue region at or near a sphincter in the anal canal. A cable is coupled to the electrode to conduct energy for application by the electrode to form a lesion in the subsurface tissue region.

Abstract: Systems for treating a mucosal surface of an alimentary canal tissue region are provided. The systems can include an elongate support structure, an expandable member positionable at a distal portion of the support structure and one or more radio frequency (RF) ablation electrodes carried by the expandable member. The elongate support structure and the expandable member can be adapted to place the one or more electrodes in contact with a mucosal surface of an alimentary canal tissue region. The system can further include an RF energy source connected to the one or more electrodes.

Abstract: Systems for treating a mucosal surface of an alimentary canal tissue region are provided. The systems can include an elongate support structure, an expandable member positionable at a distal portion of the support structure and one or more radio frequency (RF) ablation electrodes carried by the expandable member. The elongate support structure and the expandable member can be adapted to place the one or more electrodes in contact with a mucosal surface of an alimentary canal tissue region. The system can further include an RF energy source connected to the one or more electrodes.

Abstract: Methods treat a tissue region. In one arrangement, the methods deploy an endoscope in an esophagus and visualize with the endoscope a Z-line that marks a transition between esophageal tissue and stomach tissue by observing tissue color change at or near the Z-line. The methods deploy an electrode support structure over the endoscope at or near the Z-line visualized by the endoscope, wherein the endoscope serves as a guide for the electrode support structure. The methods introduce from the electrode support structure a tissue-piercing needle electrode into tissue at or near the Z-line and observe introduction of the tissue-piercing needle electrode using the endoscope. The methods couple the tissue-piercing electrode to a source of radio frequency energy to ohmically heat tissue and create a subsurface tissue lesion in tissue at or near the Z-line, and observe creation of the tissue lesion using the endoscope.

Abstract: A method detects at a tissue site an electrical activity causing a transient relaxation of at least a portion of one of a sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus. The method treats the electrical activity at the tissue site by delivering electromagnetic energy to ablate at least a portion of one of the nerve, the gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway. The method conducts a cooling solution to the tissue site at a flow rate and adjusts the flow rate in response to sensed temperature conditions.

Abstract: Methods of ablating mucosal tissue in an alimentary canal are provided. The methods can include the steps of (i) providing an ablation device comprising a tissue ablation source; (ii) positioning at least a portion of the ablation device at a mucosal tissue surface of the alimentary canal; (iii) delivering a sufficient amount of the source for tissue ablation to the mucosal tissue surface to create a lesion in the mucosal tissue. In one implementation the methods include a step of providing a radiofrequency (RF) energy delivery device.

Abstract: A usage key card is adapted to be handled separate from a device tissue treatment deice. The usage key card has a storage medium formatted to contain an identification code, which is unique to the usage key card. The usage key card is also adapted to be read by a reader separate from the device.

Abstract: Methods of accessing and ablating abnormal epithelium tissue in an alimentary canal are provided. The methods can include steps of (i) inserting a vacuum source comprising one or more suction ports into an alimentary canal; (ii) inserting an operative element comprising a conduit for a tissue ablation source into the alimentary canal; (iii) positioning the vacuum source and the operative element proximate a portion of the alimentary canal having a site of abnormal tissue to be ablated; (iv) applying a vacuum to at least one of each suction port to draw the tissue against the operative element; and (v) applying the tissue ablation source to the tissue through the conduit to effect tissue ablation.

Abstract: Methods of accessing and ablating abnormal epithelium tissue in an alimentary canal are provided. The methods can include steps of (i) inserting an operative element into an alimentary canal such that the proximate to a portion of the alimentary canal having tissue to be ablated; and (ii) using the operative element to apply cryogenic ablation to a site of abnormal tissue.

Abstract: A method for treating a sphincter provides a polymer material having a liquid state. The method also provides a catheter having a distal end, a tissue piercing device carried by the distal end, and an energy delivery device coupled to the tissue piercing device. The tissue piercing device has a lumen. The method introduces the catheter into an esophagus and pierces an exterior sphincter tissue surface within with the tissue piercing device. The method advances the tissue piercing device into an interior sphincter tissue site and conveys the polymer material while in a liquid state through the lumen into the interior sphincter tissue site. The method delivers energy to the tissue piercing device to transform the polymer material into a less liquid state within the interior sphincter tissue site, to thereby remodel the sphincter.

Abstract: Systems and methods affect tightening of the pyloric sphincter and/or serve to mediate or moderate receptive relaxation of muscles in the stomach, to treat or mitigate various physiologic conditions, such as obesity, biliary reflex, GERD, and/or Barrett's esophagus. The systems and methods may be used as either a primary treatment modality, or applied as a supplementary treatment before, during or after a primary intervention.

Abstract: A device for treating a tissue region is supplied with a separate usage key card. The usage key card comprises a storage medium, which is formatted to contain an identification code unique to the usage key card. The usage key card is adapted to be read by a remote reader, to download the identification code for processing by a controller for the device. Processing of the identification code by the controller either enables or disables operation of the device according to prescribed criteria.

Abstract: A method for treating a sphincter provides a polymer material having a liquid state. The method also provides a catheter having a distal end, a tissue piercing device carried by the distal end, and an energy delivery device coupled to the tissue piercing device. The tissue piercing device has a lumen. The method introduces the catheter into an esophagus and pierces an exterior sphincter tissue surface within with the tissue piercing device. The method advances the tissue piercing device into an interior sphincter tissue site and conveys the polymer material while in a liquid state through the lumen into the interior sphincter tissue site. The method delivers energy to the tissue piercing device to transform the polymer material into a less liquid state within the interior sphincter tissue site, to thereby remodel the sphincter.

Abstract: A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region.

Abstract: Systems and methods deploy an electrode structure in contact with the tissue region. The electrode structure carries a sensor at a known location on the electrode structure to monitor an operating condition. The systems and methods provide an interface, which generate an idealized image of the electrode structure and an indicator image to represent the monitored operating condition in a spatial position on the idealized image corresponding to the location of the sensor on the electrode structure. The interface displays a view image comprising the idealized image and indicator image. The systems and methods cause the electrode structure to apply energy to heat the tissue region while the view image is displayed on the display screen.

Abstract: Systems and methods that treat disorders of the gastrointestinal tract by applying one or more treatment agents to tissue at or near the region where abnormal neurological symptoms or abnormal tissue conditions exist. The treatment agent is selected to either disrupt the abnormal nerve pathways and/or to alleviate the abnormal tissue conditions. The treatment agent can include at least one cytokine and/or at least one vanilloid compound to evoke a desired tissue response. The systems and methods can be used a primary treatment modality, or as a neoadjuvent or adjuvant treatment modality.

Abstract: Unified systems and methods enable control of the use and operation of a family of different treatment devices, to treat dysfunction in different regions of the body.

Abstract: Devices and methods for tissue acquisition and fixation, or gastroplasty, are described. Generally, the devices of the system may be advanced in a minimally invasive manner within a patient's body to create one or more plications within the hollow body organ. A tissue treatment device attached to a distal end of a flexible elongated member and has a cartridge member opposite an anvil member. The cartridge member and the anvil member are movable between a closed position and an open position, and a moveable barrier is disposed between the cartridge and anvil members to help acquire a dual fold of tissue. The tissue treatment device can be repositioned to form multiple plications within the organ.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.