Abstract: A system for controlling a treatment device generates a graphical interface that visually prompts a user in a step-wise fashion to use the treatment device to perform a process of forming a pattern of lesions that extends both circumferentially and axially in different levels in a body region. The graphical interface displays for the user a visual record of the progress of the process from start to finish and guides the user so that so that individual lesions desired within a given level are all formed, and that a given level of lesions is not skipped.

Abstract: A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to heat tissue to create lesions without ablating the tissue. The system includes a first treatment device having at least one electrode for applying radiofrequency energy to tissue, a controller including a connector to which a first treatment device is coupled for use, and a generator for applying radiofrequency energy to the electrodes. The controller controls application of energy so that the tissue is thermally treated to create lesions but preventing thermal treatment beyond a threshold which would ablate the tissue.

Abstract: A system for controlling a treatment device generates a graphical interface that visually prompts a user in a step-wise fashion to use the treatment device to perform a process of forming a pattern of lesions that extends both circumferentially and axially in different levels in a body region. The graphical interface displays for the user a visual record of the progress of the process from start to finish and guides the user so that so that individual lesions desired within a given level are all formed, and that a given level of lesions is not skipped.

Abstract: A system for controlling a treatment device generates a graphical interface that visually prompts a user in a step-wise fashion to use the treatment device to perform a process of forming a pattern of lesions that extends both circumferentially and axially in different levels in a body region. The graphical interface displays for the user a visual record of the progress of the process from start to finish and guides the user so that so that individual lesions desired within a given level are all formed, and that a given level of lesions is not skipped.

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 system for controlling a treatment device generates a graphical interface that visually prompts a user in a step-wise fashion to use the treatment device to perform a process of forming a pattern of lesions that extends both circumferentially and axially in different levels in a body region. The graphical interface displays for the user a visual record of the progress of the process from start to finish and guides the user so that so that individual lesions desired within a given level are all formed, and that a given level of lesions is not skipped.

Abstract: A system for controlling a treatment device generates a graphical interface that visually prompts a user in a step-wise fashion to use the treatment device to perform a process of forming a pattern of lesions that extends both circumferentially and axially in different levels in a body region. The graphical interface displays for the user a visual record of the progress of the process from start to finish and guides the user so that so that individual lesions desired within a given level are all formed, and that a given level of lesions is not skipped.

Abstract: A system for controlling a treatment device generates a graphical interface that visually prompts a user in a step-wise fashion to use the treatment device to perform a process of forming a pattern of lesions that extends both circumferentially and axially in different levels in a body region. The graphical interface displays for the user a visual record of the progress of the process from start to finish and guides the user so that so that individual lesions desired within a given level are all formed, and that a given level of lesions is not skipped.

Abstract: A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region.

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 flexible sleeve mountable to an endoscope having a proximal portion, a distal portion, a first channel dimensioned to receive an endoscope, and a second channel dimensioned to receive an electrode. The electrode is slidable within the second channel from a retracted position wherein a tip of the electrode is unexposed from the sleeve and an extended position wherein the tip of the electrode is exposed from the sleeve and curves toward target tissue.

Abstract: A device carries a use monitoring element that possesses a state or condition that changes in response to use of the device and that is sensed when the device is presented for use. Reuse of the device is not permitted, if the use monitoring element indicates a prior use.

Abstract: A device for applying radiofrequency energy for sphincter treatment comprising a flexible outer tube, an expandable basket having a plurality of arms movable from a collapsed position to an expanded position, and a plurality of electrodes movable with respect to the arms from a retracted position to an extended position. An advancer is slidably disposed within the outer tube to move the plurality of electrodes to the extended position. An actuator moves the advancer from a first position to a second position to advance the plurality of electrodes. An aspiration tube extends within the outer tube. An assembly includes an aspiration disabler having a first position to enable aspiration from a distal portion of the aspiration tube to a proximal portion and a second position to disable aspiration.

Abstract: A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region.

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: A system comprising a storage medium associated with a device for treating a tissue region, the device including a handle, a catheter tube extending from the handle, a temperature sensor and a basket including a plurality of spines, the spines carrying an electrode for delivering treatment energy to a tissue site. The temperature sensor senses temperature near a distal end of the electrode. The basket is movable between a non-expanded low profile condition and an expanded condition and the electrode is movable from a first position to an extended position. The storage medium is formatted to contain an identification code uniquely assigned to the device for registration of the device if absence of prior use is determined.

Abstract: A device carries a use monitoring element that possesses a state or condition that changes in response to use of the device and that is sensed when the device is presented for use. Reuse of the device is not permitted, if the use monitoring element indicates a prior use.

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 system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to treat tissue to create lesions without ablating the tissue. The system includes a first treatment device having a plurality of electrodes. The electrodes are maintained in axial alignment and fixed radial spacing in retracted and extended positions. The device includes a basket having a plurality of arms. The arms are maintained in a fixed radial spacing in the collapsed position of the basket.

Abstract: A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to treat tissue to create lesions without ablating the tissue. The system includes a device having flexible outer tube, an expandable basket having a plurality of arms movable from a collapsed position to an expanded position, a plurality of electrodes movable from a retracted position to an extended position to extend through the openings in the arms, and an advancer slidably disposed within the outer tube to move the electrodes. An elongated spacer is positioned within the outer tube, the spacer having a central lumen to receive the advancer and to maintain a central position of the advancer.