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: An apparatus for treating tissue within a lumen may include a therapeutic or diagnostic instrument. A cleaning device may also be supported by the instrument. The cleaning device has a portion of a cleaning surface positioned proximal to the distal end of the cleaning device.

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 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: 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: Methods of ablating tissue in an alimentary tract are provided. The methods include advancing an ablation structure into an alimentary tract while supporting the ablation structure with an endoscope. The methods further include a step of moving at least part of the ablation structure with respect to the endoscope and toward a tissue surface, before activating the ablation structure to ablate a tissue surface.

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: Methods, systems, and devices for providing treatment to a target site are described. The system may include a guide assembly, an expandable support device coupled with the distal end of the guide assembly, and an operative member disposed on the expandable support device. The expandable support device may be configured to transition between a collapsed and expanded configuration. The expandable support device may be supported by one or more flexible supports aligned in parallel with an axis about which the expandable support device collapses and/or multiple splines arranged in a pattern configured to promote transitioning of the expandable support device between an expanded and collapsed configuration. The guide assembly may be configured to provide torque to the expandable support device. The operative member can include multiple electrodes arranged in parallel to the axis about which the expandable support device collapses.

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: 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 device for treating a tissue region at or near a lower esophageal sphincter to treat gastroesophageal reflux disease including a flexible tube having a plurality of arrays of first and second lumens, a proximal base, a distal hub, a plurality of radially spaced slits formed between the proximal base and distal hub, and a plurality of electrode ports and fluid ports, the electrode and fluid ports and the lumens are positioned between the slits. The tube is flexible outwardly between the slits to form an array of spines forming a three dimensional basket. A first electrode is movable within the first lumen of one array and a second electrode is movable within the first lumen of another array to exit through the electrode ports to penetrate tissue for application of energy to the tissue region to tighten the lower esophageal sphincter to treat gastroesophageal reflux disease.

Abstract: Methods, systems, and devices for providing treatment to a tissue in body lumens are described. The system may include a catheter, an expansion member coupled with a distal portion of the catheter, an ablation structure including one or more longitudinal electrode segments, and an ablation structure support coupled to the ablation structure configured to at least partially unfurl as the expansion member expands and furl as the expansion member contracts. The ablation structure may include multiple separately wired and/or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, such that each longitudinal electrode or longitudinal electrode zone may be selectively enabled or selectively disabled. In some instances, one or more springs are coupled to the ablation structure configured to promote unfurl or furl around the expansion member. In some instances, one or more protection elements are be positioned along the catheter.

Abstract: Methods, systems, and devices for providing treatment to a tissue in body lumens are described. The system may include a support shaft, an expansion member coupled with a distal portion of the support shaft, and an ablation structure wrapped around the expansion member less than a circumference of the expansion member configured to engage the body lumens with varying sizes. The ablation structure may include multiple separately wired or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, such that each longitudinal electrode or longitudinal electrode zone may be selectively enabled or selectively disabled. The expansion member may include a single highly-compliant balloon, a single non-compliant balloon, multiple non-compliant balloons, or a multi-chambered non-compliant balloon.

Abstract: Methods, systems, and devices for providing treatment to a tissue in body lumens are described. The system may include a catheter, an expansion member coupled with a distal portion of the catheter, an ablation structure including one or more longitudinal electrode segments, and an ablation structure support coupled to the ablation structure configured to at least partially unfurl as the expansion member expands and furl as the expansion member contracts. The ablation structure may include multiple separately wired and/or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, such that each longitudinal electrode or longitudinal electrode zone may be selectively enabled or selectively disabled. In some instances, one or more springs are coupled to the ablation structure configured to promote unfurl or furl around the expansion member. In some instances, one or more protection elements are be positioned along the catheter.

Abstract: Methods, systems, and devices for providing treatment to a tissue in body lumens are described. The system may include a catheter, an expansion member coupled with a distal portion of the catheter, an ablation structure including one or more longitudinal electrode segments, and an ablation structure support coupled to the ablation structure configured to at least partially unfurl as the expansion member expands and furl as the expansion member contracts. The ablation structure may include multiple separately wired and/or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, such that each longitudinal electrode or longitudinal electrode zone may be selectively enabled or selectively disabled. In some instances, one or more springs are coupled to the ablation structure configured to promote unfurl or furl around the expansion member. In some instances, one or more protection elements are be positioned along the catheter.

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: 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. 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.

Abstract: An apparatus treats tissue at or near a sphincter. The apparatus has an elongated member having at least one lumen including an inflation lumen, and a basket assembly including a first and a second arm. An inflatable member is coupled to the inflation lumen and has a deployed and a non-deployed state. In the deployed state, the inflatable member expands the basket assembly into contact with tissue. At least one of the first and second arms of the basket assembly has a fluid lumen having an aperture for conveying a fluid from the basket assembly. A source of fluid is coupled to the fluid lumen for conveyance of fluid through the aperture. The fluid can be, e.g., an electrolytic solution, and/or an anti-infection agent, and/or an echogenic media, and/or a steroid, and/or an anesthetic, and/or a medicament, and/or a tissue cooling agent. The source can be a drug delivery device.

Abstract: A method and apparatus for treating abnormal mucosa in the esophagus is disclosed, such that the depth of the treated tissue is controlled. The depth of ablation is controlled by monitoring the tissue impedance and/or the tissue temperature. A desired ablation depth is also achieved by controlling the energy density or power density, and the amount of time required for energy delivery. A method and apparatus is disclosed for measuring an inner diameter of a body lumen, where a balloon is inflated inside the body lumen at a fixed pressure.