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: 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 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 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 and methods for treating a tissue region employ an expandable structure projecting beyond the distal end of a catheter tube. A distal tail projects beyond the far end of the basket assembly. The distal tail includes a guidewire lumen that accommodates passage of a guidewire without threading the guidewire through the catheter tube.

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: A method and apparatus for treating abnormal mucosa in the esophagus is disclosed, such that the depth of the treated tissue is controlled. The depth of ablation is controlled by monitoring the tissue impedance and/or the tissue temperature. A desired ablation depth is also achieved by controlling the energy density or power density, and the amount of time required for energy delivery. A method and apparatus is disclosed for measuring an inner diameter of a body lumen, where a balloon is inflated inside the body lumen at a fixed pressure.

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. A viewable image is generated on a display screen that changes in response to processing of the identification code.

Abstract: A method of forming a composite lesion pattern in a tissue region at or near a sphincter comprising providing a catheter having a plurality of energy delivery devices coupled to the catheter. The catheter is introduced at least partially into the sphincter. Energy is delivered from the energy delivery devices to produce the composite lesion pattern. The composite lesion pattern comprises a radial distribution of lesions about the tissue region and a longitudinal distribution of lesions along the tissue region.

Abstract: A method of treating a sphincter provides a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter, the lower esophageal sphincter, stomach, the cardia or the fundus. Bioelectric activity causing a relaxation of the sphincter is detected and energy is delivered from either the mapping electrode or the treatment electrode to treat the bioelectric activity. A method of treating a sphincter provides a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter, the lower esophageal sphincter, stomach, the cardia or the fundus.

Abstract: An apparatus includes an expandable member. The expandable member is sized to be positionable in a sphincter. An energy delivery device is positioned on a surface of the expandable member. The energy delivery device has a configuration that provides sufficient energy delivery to create lesions in the interior of the sphincter. When the expandable member is removed from the sphincter, the sphincter returns to its closed or contracted configuration.

Abstract: An intraoral aversion device to assist a user in quitting an undesirable behavior such as tobacco smoking, tobacco chewing, use of snuff, illicit drug use, excessive alcohol consumption, excessive food consumption, and/or other undesirable activity facilitated via the mouth. The aversion device may be wholly or partially configured to be disposed in the user's mouth, for example. The aversion device may include a detector and a output device, wherein the detector is configured to detect a parameter indicative of the user engaging in the habit or undesirable activity. If (and only if) the detector detects such a parameter, the output device delivers a negative stimulus to the user, thus providing negative feedback and creating an incentive for the user to limit if not eliminate the undesirable activity.

Abstract: A sphincter treatment apparatus includes an energy delivery device introduction member including a proximal end with a first radius of curvature and a distal end with a second radius of curvature. The introduction member is configured to be introduced into the sphincter in a non-deployed state and to be expanded to a deployed state to at least partially expand the sphincter or an adjoining structure. An energy delivery device is coupled to the introduction member. A retainer member is coupled to the energy delivery device introduction member and configured to controllably position the introduction member in an orifice of the sphincter.

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: 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.

Abstract: Methods treat a tissue region. In one arrangement, the methods deploy an electrode on a support structure in a tissue region at or near the cardia of the stomach. In one embodiment, the support structure has a proximal region and a distal region. The proximal region is enlarged in comparison to the distal region, and the electrode is carried by the enlarged proximal surface. The methods advance the electrode in a path to penetrate the tissue region and couple the electrode to a source of radio frequency energy to ohmically heat tissue and create a lesion in the tissue region.

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: 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: 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: Systems and methods apply a selected treatment agent or agents into contact with tissue at or in the region of a dysfunctional sphincter (in the case of GERD, fecal incontinence, or other dysfunctional sphincter disorders) to affect improved sphincter barrier function and/or to disrupt abnormal nerve pathways. The treatment agent can include at least one cytokine and/or at least one tissue bulking agent 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 applied as a supplementary treatment before, during or after a primary intervention.