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 device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: An implantable lead device and method for implanting the lead, wherein the lead device electrically stimulates tissue within a patient's body and more particularly the lead device stimulates gastrointestinal tissue. The implantable lead may be inserted through the tissue with minimal expansion of the penetration tunnel and attached to the tissue being stimulated with minimal efforts or apparatus. The implantable lead has flexible properties thus minimizing the potential for electrode erosion, maximizing tissue compliance, and minimizing the mechanical stress concentration that may result in fatigue failure in the lead.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate urinary or fecal incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

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: Devices, systems and methods are provided for electrical stimulation of a body organ, particularly within the gastrointestinal tract. In preferred embodiments, the stomach is the organ within the gastrointestinal tract which is targeted for such stimulation. A guide wire or other delivery device is positioned within the body so as to transect the stomach wall. Devices and systems are then advanced over the guide wire for attachment to the stomach wall. The guide wire may be placed by endoscopic, open, laparoscopic or a modified percutaneous approach. In a modified percutaneous approach, the stomach is accessed without the use of general anesthesia by advancing a needle through the abdomen, transecting the stomach wall with the needle and advancing the guide wire through the needle.

Abstract: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: A method is provided for detecting a change in posture of a subject. An electrical impedance is measured between two or more sites on a stomach (20) of the subject, and an impedance signal is generated responsive thereto. The change in posture is detected by performing a posture analysis of the impedance signal. A method is also provided for treating a subject. The method includes applying an electrical signal to a site of the subject selected from the list consisting of: a colon (402) of the subject, and a distal small intestine (408) of the subject. The signal is configured to stimulate cells of the subject to increase secretion of glucagon-like-peptide-1 (GLP-1) or PYY, or to decrease secretion of ghrelin, in order to treat the subject.

Abstract: An endoscopic delivery system is provided to deliver a functional device through the esophagus and into the stomach where it is attached the stomach wall The endoscopic instruments attach or remove the attachment devices and functional devices from the stomach and may be used to assist in determining the optimal attachment location.

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: An implantable intramuscular lead system, such as for use as a gastric lead, and method of use in which electrodes along the lead are imbedded in tissue. First and second anchors are mounted on an elongate lead. At least the second anchor is movable along the length of the lead relative to the first anchor to capture the tissue between the anchors so that the lead is retained in position. The system facilitates implantation of the lead in tissue, and may be particularly suited for minimally invasive implantation, such as laparoscopically.

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: 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.

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 patient is treated with electrode positioned within a lumen of an esophagus of the patient and positioned at a mucosal layer of the esophagus. An electrical signal is applied to the electrode to to create a neural conduction block on a vagal trunk external to the esophagus.

Abstract: A device and method are provided for treating obesity by implanting an electrode in the duodenum and stimulating the duodenum with a stimulator, causing the pylorus to contract.

Abstract: Systems and methods deploy a therapeutic or diagnostic element into contact with a body tissue region. The systems and methods can sense position of the therapeutic or diagnostic element relative to a targeted tissue region without direct or indirect visualization, by sensing fluid pressure in a fluid path having an outlet located at or near the therapeutic or diagnostic element. The systems and methods can also inflate the therapeutic or diagnostic element during use, while taking steps to avoid over-inflation and/or while dynamically monitoring the pressure conditions within the expanded element.

Abstract: A lower esophageal sphincter tightening device for treating gastroesophageal reflux disease which includes an insertion device, an energy source, and an energy transmitting device. The insertion device, by insertion through a body opening, positions the energy transmitting device in the proximity of the lower esophageal sphincter. The energy source generates and transmits energy via the insertion device to the energy transmitting device which directs the transmitted energy onto the lower esophageal sphincter which is comprised largely of collagen. The energy source transmits energy at a level sufficient to cause heating of the sphincter's collagen resulting in a shrinkage of the collagen and a tightening of the sphincter.

Abstract: Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of tissue volumes at two or more locations adjacent sacral nerves or portions thereof, and/or pudendal nerves of portions thereof. Two or more electrical stimulation regimes are applied on a continuous, alternating, intermittent or other basis to the respective tissue volumes in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary and/or fecal voiding dysfurictions such as constipation, incontinence disorders such as urge frequency and urinary retention disorders, sexual dysfunctions such as orgasmic and erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Abstract: Devices and methods are provided for treatment of tissue in a body lumen with an electrode deployment device. Embodiments typically include a device with a plurality of electrodes having a pre-selected electrode density arranged on the surface of a support. The support may comprise a non-distensible electrode backing that is spirally furled about an axis and coupled to an expansion member such as an inflatable elastic balloon. In some embodiments, the balloon is inflated to selectively expose a portion of the electrode surface while maintaining the electrode density.

Abstract: The disclosure describes a medical lead with a retrieval wire that extends from the proximal end of the lead. The retrieval wire allows a physician to insert the medical lead into a patient and grab the retrieval wire to pull the proximal end of the lead away from the implant site. Upon gaining access to a lead connector on the proximal end of the medical lead, the physician may remove the retrieval wire and couple the lead connector to an implantable medical device that provides stimulation therapy. In this manner the physician may avoid damaging the lead connector when retrieving the medical lead. In addition, the retrieval wire may be used to provide test stimulation to verify correct electrode location. The medical lead may be used to stimulate tissue such as the stomach, small intestine, and the large intestine.

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: The invention provides methods and devices to reduce stomach acid secretion in a patient with a hyper acid condition. For example, the invention may involve ablation of the stomach lining to destroy acid-producing cells. Destroying acid-producing cells may reduce the amount of stomach acid produced and, therefore the amount of acid refluxed in the esophagus. The invention may further provide methods and devices to monitor the esophageal acid level before and after the ablation procedure.

Abstract: In general, an implantable medical device is disclosed for generating and applying an electric stimulation signal to a portion of a patient's gastrointestinal tract to induce symptoms of gastroparesis in the patient without substantially reducing normal stomach motility. The induced symptoms of gastroparesis may reduce a patient's desire to consume large portions of food and thus provide an effective treatment for obesity.

Abstract: At least one of a plurality of disorders of a patient characterized at least in part by vagal activity innervating at least one of a plurality of organs of the patient is treated by a method that includes positioning a neurostimulator carrier around a body organ of the patient where the organ is innervated by at least a vagal trunk. An electrode is disposed on the carrier and positioned at the vagal trunk. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. The signal may be a blocking or a stimulation signal.

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: The device and method for placement of an instrument, specifically electrodes, in the GI tract allows for placement of electrodes for gastric electrical stimulation into the gastric wall using endoscopic techniques. The device has one or more electrodes disposed on an elongated body having a pointed first end and a bolster disposed on a second end. When placed within the GI tract, the first end of the device extends through the gastric and abdominal walls, extending outside of the patient's body with the bolster in contact against the inner lining of the gastric wall to retain the device. Exposed electrodes contact the gastric smooth muscle. Insulated wires in electrical connection with-the electrodes run the length of the device body. Once the device is placed, the first end of the device body is removed to expose the wires, allowing electrical connection to an external electrical signal generator to provide electrical stimulus.

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: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: A fixation device for holding stimulating electrodes in electrical contact with the wall of a portion of the gastrointestinal tract is provided. In one embodiment, the fixation device includes an expandable member that fixes the electrodes in electrical contact with the gastrointestinal tract wall. Also provided is an implantable device and method for controlling the opening and/or closing of the pylorus. In particular a device and method is provided for stimulating the duodenum to control the closing/and or opening of the pylorus. Finally, a method is provided for treating obesity by controlling the pylorus to retain food in the stomach for a desired period of time, among other things to provide a feeling of satiety and/or to reduce hunger. One aspect includes controlling the pylorus's contraction by electrical stimulation of the duodenum.

Abstract: A lower esophageal sphincter tightening device for treating gastroesophageal reflux disease which includes an insertion device, an energy source, and an energy transmitting device. The insertion device, by insertion through a body opening, positions the energy transmitting device in the proximity of the lower esophageal sphincter. The energy source generates and transmits energy via the insertion device to the energy transmitting device which directs the transmitted energy onto the lower esophageal sphincter which is comprised largely of collagen. The energy source transmits energy at a level sufficient to cause heating of the sphincter's collagen resulting in a shrinkage of the collagen and a tightening of the sphincter.

Abstract: A non-invasive percutaneously acting apparatus for relieving constipation or diarrhea and appropriately stimulating peristaltic movement in the human gastro-intestinal (GI) tract. The apparatus includes an annular or toroidal shaped hollow housing having a working surface on one side thereof. A multi-point electrode generally coextensive with the working surface includes a plurality of point electrodes each separately mounted in and preferably biasingly moveably extend outwardly from the working surface. A d.c. pulse generator selectively and sequentially connectable to the point electrodes whereby, when the working surface is positioned against or in close proximity to the skin over the GI tract, the point electrodes deliver electrical pulses percutaneously and sequentially moving from one point electrode to the next adjacent point electrode repeatedly around the working surface.

Abstract: A device, system and method for diagnosing and treating a patient is provided where a functional device is attached to a stomach wall. The device in one embodiment provides electrical stimulation of the stomach wall. The device may also have other functional aspects such as a sensor for sensing various parameters of the stomach or stomach environment, or a substance delivery device. The implant may be programmed to respond to sensed information or signals. The device may be modular with a portion of the device accessible for removal and replacement. In one embodiment, an endoscopic delivery system delivers the functional device through the esophagus and into the stomach where it is attached the stomach wall with the assistance of a suction used to stabilize the tissue of the stomach wall. The device includes a chamber for receiving tissue of the stomach wall for attachment where a vacuum pressure is applied through the chamber to draw the tissue into the chamber.

Abstract: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: Instruments for thermally-mediated treatment of a patient's lower esophageal sphincter (LES) to induce an injury healing response to thereby populate the extracellular compartment of walls of the LES with collagen matrices to altere the biomechanics of the LES to provide an increased intra-esophageal pressure for preventing acid reflux. A preferred embodiment is a bougie-type device for trans-esophageal introduction that carries conductive electrodes for delivering Rf energy to walls of the LES (i) to induce the injury healing response or (ii) to “model” collagenous tissues of the LES by shrinking collagen fibers therein.

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: Active fixation, gastrointestinal leads adapted to be implanted within the body at a site of the GI tract to conduct electrical stimulation from an implantable or external gastrointestinal stimulator to the site and to conduct electrical signals of the GI tract from the site to the implantable or external gastrointestinal stimulator are disclosed. Disclosed active fixation mechanisms include one or more of hooks, and helixes extending from stops, e.g. plates, of an electrode head and functioning as stimulation/sense electrodes in unipolar and bipolar configurations or simply as fixation mechanisms. The active fixation mechanisms are coated to reduce inflammation and polarization effects.

Abstract: A method and apparatus for electrical stimulation of the lower esophageal sphincter (LES) is provided. Electrode sets are placed in the esophagus in an arrangement that induce contractions of the LES by electrical stimulation of the surrounding tissue and nerves. The electrical stimulus is applied by a pulse generator for periods of varying duration and varying frequency so as to produce the desired contractions. The treatment may be short-term or may continue throughout the life of the patient in order to achieve the desired therapeutic effect. The stimulating electrode sets can be used either alone or in conjunction with electrodes that sense esophageal peristalsis. The electrode sets can be placed endoscopically, surgically or radiologically.

Abstract: The device (1) for controlling the extent of intra-abdominal fat in the monitoring of an individual's slimming, comprises one electrical signal generator (2) connected to at least one first pole (3), associable to the stomach surface, and a second pole (4), associable to the abdominal wall. The poles (3,4) are connected to detection means (6) and means (7) for processing said electrical signals, adapted to provide a signal indicating the extent of intra-abdominal fat. The control procedure of the entity of the intra-abdominal fat in the monitoring of an individual's slimming, consists in detecting the impedance of the abdominal fat tissues, and hence, in calculating the extent of intra-abdominal fat is obtained.

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, system and method for diagnosing and treating a patient is provided where a functional device is attached to a stomach wall. The device in one embodiment provides electrical stimulation of the stomach wall. The device may also have other functional aspects such as a sensor for sensing various parameters of the stomach or stomach environment, or a substance delivery device. The implant may be programmed to respond to sensed information or signals. The device may be modular with a portion of the device accessible for removal and replacement. In one embodiment, an endoscopic delivery system delivers the functional device through the esophagus and into the stomach where it is attached the stomach wall with the assistance of a suction used to stabilize the tissue of the stomach wall. The device includes a chamber for receiving tissue of the stomach wall for attachment where a vacuum pressure is applied through the chamber to draw the tissue into the chamber.

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.

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: 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.