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 sphincter treatment apparatus includes an energy delivery device introduction member including a plurality of arms. Each arm has distal and proximal sections. The distal sections of the arms are coupled as are the proximal sections of the arms. The energy delivery device introduction member is configured to be introduced in the sphincter in a non-deployed state, expand to a deployed state to at least partially expand the sphincter. A plurality of energy delivery devices are coupled to the energy delivery device introduction member. At least a portion of the plurality of energy delivery devices are controllably introducible from the energy delivery device introduction member into the sphincter.

Abstract: Improved electrode assemblies for treating a tissue region at or near a sphincter comprise a support structure and an electrode carried by the support structure for advancement in a path to penetrate the tissue region. In one arrangement, the electrode has a non-cylindrical cross section selected to resist deflection when advanced to penetrate the tissue region. In another arrangement, the electrode includes a tissue stop to resist tissue penetration beyond a selected depth. In another arrangement, the electrode includes a proximal portion formed from a first material and a distal tissue penetrating portion formed of a second material different than the first material. The first material can comprise, e.g., stainless steel, and the second material can comprise, e.g., nickel titanium.

Abstract: An apparatus to treat a sphincter includes a catheter means including a catheter means distal portion means. An energy delivery device means is coupled to the catheter means and includes a tissue piercing distal end. The energy delivery device means is configured to pierce a sphincter exterior surface, advance a sufficient distance in an interior of the sphincter to a tissue site, deliver energy to the tissue site and create controlled cell necrosis of the sphincter in order to reduce a frequency of sphincter relaxation. A cable means is coupled to the energy delivery device means.

Abstract: Assemblies for treating a tissue region at or near a sphincter have a support structure with a distal end and an electrode carried by the support structure for contact with the tissue region. A lumen in the support structure accommodates passage of a body through the support structure and beyond the distal end of the support structure. The body can comprise a guide wire to guide deployment of the support structure, or an endoscope to permit visualization of the support structure from beyond the distal end of the support structure.

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 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.

Abstract: Systems and methods manipulate a support structure to form a composite lesion in a tissue region at or near a sphincter. The support structure carries an array of electrodes attachable to a source of energy capable of heating tissue when transmitted by the electrodes. The systems and methods advance the electrodes to penetrate the tissue region and form, when the energy is transmitted, a first pattern of lesions. The systems and methods retract the electrodes, and shift the position of the electrodes, either rotationally, or axially, or both rotationally and axially. The systems and methods advance the electrodes a second time to form, when the energy is transmitted, a second pattern of lesions either rotationally or axially or both rotationally and axially shifted from the first pattern of lesions. The first and second patterns of lesion together comprise the composite lesion.

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 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: Multiple electrodes are coupled together in monopolar or bipolar arrays to form lesion patterns in tissue regions at or near a sphincter. A controller couples the electrodes to a generator so that a single power channel serves more than a single electrode.

Abstract: Systems and methods treat a tissue region at or near a sphincter by deploying a carrier, which carries an electrode that can be advanced to penetrate tissue. Negative pressure is applied through a suction port on the carrier near the electrode, to draw tissue in the tissue region inward against the carrier. The systems and methods advance the electrode to penetrate tissue drawn against the carrier. The vacuum anchors the surrounding tissue and mediates against the “tenting” of tissue during electrode penetration. Without tenting, the electrode penetrates mucosal tissue fully, to obtain a desired depth of penetration.

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 integrate the control of an energy generator, to supply energy to an electrode structure to heat a tissue region, and the control of a pumping mechanism, to supply cooling fluid to control tissue temperature in the region.

Abstract: Expandable assemblies for treating a tissue region at or near a sphincter comprises a support basket formed from an array of spines. A mechanism flexes the spines to expand and collapse the basket. Electrodes carried by the spines for advancement in a path to penetrate the tissue region upon expansion of the basket. The basket can be formed from a mechanical array of molded, jointed spines, or from an extruded tube having axial slits forming the spines.

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.