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: An assembly for treating tissue in the anal canal uses a barrel structure having a dimension that can be selectively altered to be conducive for insertion into an anal canal according to an anatomic condition assessed within the anal canal. An electrode is carried by the barrel structure that can be coupled to a source of tissue ablation energy, which, when applied through the electrode, forms a lesion.

Abstract: This invention provides a method and system for the curative treatment of obesity. A first aspect of this invention is that it enables identification of the nerves responsible for the relaxation of the stomach muscles that occurs prior to and during eating. A second aspect of the invention is that it allows the physician to identify focal nerve sites in the stomach and upper duodenum that are associated with producing sensations of hunger and satiety. Nervous transmission from these sites can be modulated or blocked all together so as to minimize the sensation of hunger. A third aspect of this invention is that allows a physician to shrink selected portions of the innermost oblique muscle and middle circular muscle layers of the stomach. This can be performed in a physician's office using local anesthesia. Shrinkage of these muscles produces a feeling of satiety that enhances the patient's efforts to restrict his caloric intake.

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: 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: An apparatus to treat a sphincter has a support member. A sphincter electropotential mapping device includes a mapping electrode. The sphincter electropotential mapping device is coupled to the support member and configured to detect aberrant myoelectric activity of the sphincter.

Abstract: Systems and methods treat hemorrhoids by introducing a treatment device into the anal canal to extend above a hemorrhoidal plexus and adjacent a tissue region containing blood vessels that feed the hemorrhoidal plexus. The systems and methods operate the treatment device to affect tissue morphology in the tissue region to occlude or otherwise reduce blood flow through the vessels.

Abstract: Systems and methods are provided for positioning and stabilizing an external instrument during insertion of the instrument through the oral cavity (e.g., insertion of a catheter through the oral cavity and into the esophagus or cardia for treatment of gastroesophageal reflux disease (GERD)). The systems and methods provide a gripping tool for association with a bite block, capable of selectively moving between an open position in which the instrument may be inserted or removed, and a closed position in which the external instrument is held in a fixed position.

Abstract: A sphincter treatment apparatus includes an elongated member having at least one lumen including an inflation lumen and a basket assembly with first and second arms. The basket assembly is coupled to the elongated member and has deployed and non-deployed configurations. An inflatable member is coupled to the elongated member and positioned in an interior of the basket assembly. The inflatable member has deployed and non-deployed states and is coupled to the inflation lumen. In the deployed state, the inflatable member expands the basket assembly to its deployed configuration. A first energy delivery device is positionable in the first arm and advanceable from the first arm to a selected treatment site. A second energy delivery device is positionable in the second arm and advanceable from the second arm to a selected treatment site.

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 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 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: The present invention comprises a method of treating a sphincter that 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. In another embodiment of the method of the invention, a method of treating a sphincter that 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: 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: 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 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: An apparatus to treat a sphincter includes an energy delivery device support member. An energy delivery device is coupled to the energy delivery support member. The energy delivery device has a configuration that controllably produces lesions of a sufficient size and number in the sphincter to create a selectable tightening of the sphincter.

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 sphincter treatment apparatus has an introducer means including a distal portion means. An expandable device means includes a plurality of arm means. Each arm means of the plurality has a distal section means and a proximal section means. Each of distal sections means of the arm means are coupled and each of the proximal sections means of the arm means are coupled to the introducer means distal portion means. The expandable device means is configured to at least partially dilate a sphincter in a deployed state. An energy delivery device means is introduceable from the introducer means into a selected site of the sphincter. The energy delivery device means is configured to deliver sufficient energy to reduce a frequency of relaxation of the sphincter.