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: 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 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: 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: 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 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: A device for treating a tissue region is supplied with a separate usage key card. The usage key card comprises a storage medium, which is formatted to contain an identification code unique to the usage key card. The usage key card is adapted to be read by a remote reader, to download the identification code for processing by a controller for the device. Processing of the identification code by the controller either enables or disables operation of the device according to prescribed criteria. A viewable image is generated on a display screen that changes in response to processing of the identification code.

Abstract: A usage key card is adapted to be handled separate from a device tissue treatment deice. The usage key card has a storage medium formatted to contain an identification code, which is unique to the usage key card. The usage key card is also adapted to be read by a reader separate from the device.

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: 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 device for treating a tissue region at or near a sphincter including a proximal support, a distal support and an expandable basket having a plurality of spines. The spines have a proximal portion, a distal portion and an intermediate portion therebetween, wherein the spines are movable from a first non-expanded position to a second expanded position wherein in the expanded position the intermediate portion of the spines extends outwardly radially beyond the proximal and distal portions of the spines. A plurality of electrodes are carried by the spines and movable outwardly to an outward position to penetrate tissue for application of energy to the tissue region.

Abstract: A method of regulating temperature at a tissue site comprising measuring sphincter tissue temperature at or near a tissue site, comparing the measured sphincter tissue temperature to a desired temperature, increasing an existing flow rate of a cooling solution to the tissue site if the measured tissue temperature exceeds the desired temperature, and maintaining the existing flow rate of the cooling solution to the tissue site if the measured temperature does not exceed the desired temperature.

Abstract: A device for treating a tissue region is supplied with a separate usage key card. The usage key card comprises a storage medium, which is formatted to contain an identification code unique to the usage key card. The usage key card is adapted to be read by a remote reader, to download the identification code for processing by a controller for the device. Processing of the identification code by the controller either enables or disables operation of the device according to prescribed criteria. A viewable image is generated on a display screen that changes in response to processing of the identification code.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.

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: 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: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.

Abstract: Systems and methods deploy an electrode from a catheter assembly. The systems and methods provide a catheter handle having a trigger lever adapted to carry an actuator rod. The actuator rod is adapted to cause movement of the electrode between a retracted position and an extended position. A pinion is carried by the trigger lever for engagement with a rack carried by the actuator rod. Compression of the trigger lever moves the rack along the actuator rod between a first position corresponding to the electrodes being in the retracted position and a second position corresponding to either the primed electrode firing position or the electrodes being in an extended position.

Abstract: An obesity treatment system has a first treatment region sized and configured for deployment in a duodenum and a second treatment region sized and configured for deployment in a stomach. The first and second treatment regions are spaced apart a distance sized and configured to permit simultaneous deployment of the first treatment region in the duodenum and deployment of the second treatment region in the stomach. The first and second treatment regions each carry at least one electrode, which can deliver energy to ablate tissue in and the duodenum.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.