Abstract: Systems and methods treat a tissue region. In one arrangement, the systems and methods deploy an electrode on a support structure in a tissue region at or near the cardia of the stomach. 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 systems and 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. In another arrangement, the systems and methods treat abnormal epithelium tissue at or near the lower esophageal sphincter by bringing an array of surface electrodes into contact with abnormal epithelium tissue. The systems and methods couple the surface electrodes to a source of radio frequency energy to ohmically heat tissue and cause necrosis of the abnormal epithelium tissue.

Abstract: An assembly for treating tissue at or near the sphincter includes a support structure for deployment in a tissue region, and a an electrode carried by the support structure. The support structure includes a spine with a lumen having an exit port, the electrode being deployable from the exit port. The spine also includes a cooling lumen and as aspiration lumen to provide and remove fluids, respectively.

Abstract: Electrode assemblies actively cool mucosal surface tissue at or near a sphincter while applying energy through an electrode to ohmically heat tissue beneath the surface. The applied energy creates one or more lesions, or a prescribed pattern of lesions, below the mucosal surface. Natural healing of the subsurface lesions leads to a physical tightening of the sphincter and/or adjoining tissue to treat sphincter dysfunction. The active surface cooling preserves and protects the mucosal surface against thermal damage. Furthermore, electrode assemblies can deliver a therapeutic material to the tissue region independent of or as an adjunct to lesion formation. The therapeutic material can comprise, e.g., a tissue ablating chemical; or a drug, such as a tissue growth factor, or a fibrosis inducer, or a fibroblast growth factor, or a sclerosant; or a tissue bulking agent; or an exotoxin.

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 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 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: 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.