Abstract: Described herein are devices, systems and methods for treatment of tissue within a lumen of a body. For example, the devices described herein may be used to treat the urethra or gastrointestinal tract, including a sphincter. These devices may provide an expandable element at the distal end of an elongate body and may also include a plurality of electrodes (e.g., needle electrodes) configured to extend from the device and into the tissue to deliver energy to multiple, circumferentially arranged treatment sites. Sufficient energy may be delivered from the device to create a desired tissue effect.

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: Systems for treating a mucosal surface of an alimentary canal tissue region are provided. The systems can include an elongate support structure, an expandable member positionable at a distal portion of the support structure and one or more radio frequency (RF) ablation electrodes carried by the expandable member. The elongate support structure and the expandable member can be adapted to place the one or more electrodes in contact with a mucosal surface of an alimentary canal tissue region. The system can further include an RF energy source connected to the one or more electrodes.

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 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: Systems for treating a mucosal surface of an alimentary canal tissue region are provided. The systems can include an elongate support structure, an expandable member positionable at a distal portion of the support structure and one or more radio frequency (RF) ablation electrodes carried by the expandable member. The elongate support structure and the expandable member can be adapted to place the one or more electrodes in contact with a mucosal surface of an alimentary canal tissue region. The system can further include an RF energy source connected to the one or more electrodes.

Abstract: Methods treat a tissue region. In one arrangement, the methods deploy an endoscope in an esophagus and visualize with the endoscope a Z-line that marks a transition between esophageal tissue and stomach tissue by observing tissue color change at or near the Z-line. The methods deploy an electrode support structure over the endoscope at or near the Z-line visualized by the endoscope, wherein the endoscope serves as a guide for the electrode support structure. The methods introduce from the electrode support structure a tissue-piercing needle electrode into tissue at or near the Z-line and observe introduction of the tissue-piercing needle electrode using the endoscope. The methods couple the tissue-piercing electrode to a source of radio frequency energy to ohmically heat tissue and create a subsurface tissue lesion in tissue at or near the Z-line, and observe creation of the tissue lesion using the endoscope.

Abstract: A minimally invasive treatment and appartus for treating medical conditions of hollow organs is described. Electrodes positioned within the organ and in surface contact with the underlying glands, nerves, and muscle walls of the organ apply energy to specific glandular, nerve, or muscular areas to alter the organ's operation.

Abstract: A method detects at a tissue site an electrical activity causing a transient relaxation of at least a portion of one of a sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus. The method treats the electrical activity at the tissue site by delivering electromagnetic energy to ablate at least a portion of one of the nerve, the gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway. The method conducts a cooling solution to the tissue site at a flow rate and adjusts the flow rate in response to sensed temperature conditions.

Abstract: Methods of ablating mucosal tissue in an alimentary canal are provided. The methods can include the steps of (i) providing an ablation device comprising a tissue ablation source; (ii) positioning at least a portion of the ablation device at a mucosal tissue surface of the alimentary canal; (iii) delivering a sufficient amount of the source for tissue ablation to the mucosal tissue surface to create a lesion in the mucosal tissue. In one implementation the methods include a step of providing a radiofrequency (RF) energy delivery device.

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: Methods of accessing and ablating abnormal epithelium tissue in an alimentary canal are provided. The methods can include steps of (i) inserting an operative element into an alimentary canal such that the proximate to a portion of the alimentary canal having tissue to be ablated; and (ii) using the operative element to apply cryogenic ablation to a site of abnormal tissue.

Abstract: Methods of accessing and ablating abnormal epithelium tissue in an alimentary canal are provided. The methods can include steps of (i) inserting a vacuum source comprising one or more suction ports into an alimentary canal; (ii) inserting an operative element comprising a conduit for a tissue ablation source into the alimentary canal; (iii) positioning the vacuum source and the operative element proximate a portion of the alimentary canal having a site of abnormal tissue to be ablated; (iv) applying a vacuum to at least one of each suction port to draw the tissue against the operative element; and (v) applying the tissue ablation source to the tissue through the conduit to effect tissue ablation.

Abstract: A method for treating a sphincter provides a polymer material having a liquid state. The method also provides a catheter having a distal end, a tissue piercing device carried by the distal end, and an energy delivery device coupled to the tissue piercing device. The tissue piercing device has a lumen. The method introduces the catheter into an esophagus and pierces an exterior sphincter tissue surface within with the tissue piercing device. The method advances the tissue piercing device into an interior sphincter tissue site and conveys the polymer material while in a liquid state through the lumen into the interior sphincter tissue site. The method delivers energy to the tissue piercing device to transform the polymer material into a less liquid state within the interior sphincter tissue site, to thereby remodel the sphincter.

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: A method for treating a sphincter provides a polymer material having a liquid state. The method also provides a catheter having a distal end, a tissue piercing device carried by the distal end, and an energy delivery device coupled to the tissue piercing device. The tissue piercing device has a lumen. The method introduces the catheter into an esophagus and pierces an exterior sphincter tissue surface within with the tissue piercing device. The method advances the tissue piercing device into an interior sphincter tissue site and conveys the polymer material while in a liquid state through the lumen into the interior sphincter tissue site. The method delivers energy to the tissue piercing device to transform the polymer material into a less liquid state within the interior sphincter tissue site, to thereby remodel the sphincter.

Abstract: A delivery device is disclosed, which may include a needle and at least one deployable electrode retractable into the needle in a retracted geometry that may be substantially straight. The at least one deployable electrode may be operatively connectable to a radiofrequency energy source for delivery of radiofrequency energy. At least a distal portion of the at least one electrode may be deployable, from the needle in a lateral direction relative to a longitudinal axis of the needle, to a deployed geometry that may include at least one radius of curvature in three planes. The deployed geometry may include a helical portion.

Abstract: An ablation apparatus includes an ablation energy source producing an electromagnetic energy output. A multiple antenna device is included, and has a primary antenna with a longitudinal axis, a central lumen and a distal end, and a secondary antenna with a distal end. The secondary antenna is deployed from the primary antenna central lumen in a lateral direction relative to the longitudinal axis. The multiple antenna device is coupled to the ablation energy source.

Abstract: A medical probe device comprises a catheter having a stylet guide housing with one or more stylet ports in a side wall thereof and a stylet guide for directing a flexible stylet outward through the stylet port and through intervening tissue at a preselected, adjustable angle to a target tissue. The total catheter assembly includes a stylet guide lumen communicating with the stylet port and a stylet positioned in said stylet guide lumen for longitudinal movement from the port through intervening tissue to a target tissue. The stylet can be an electrical conductor enclosed within a non-conductive layer, the electrical conductor being a radiofrequency electrode. Preferably, the non-conductive layer is a sleeve which is axially moveable on the electrical conductor to expose a selected portion of the electrical conductor surface in the target tissue. The stylet can also be a microwave antenna. The stylet can also be a hollow tube for delivering treatment fluid to the target tissue.

Abstract: Systems and methods introduce a closure material to seal a vessel puncture site. The system and methods provide a catheter adapted for passage through a tissue puncture and sized to occupy substantially all the tissue puncture. The catheter includes a lumen in fluid communication with a fluid delivery port adjacent the catheter distal end. One or more dispensers are in fluid communication with the catheter lumen for dispensing first and second fluid compositions in the catheter lumen. An actuator causes the first and second fluid compositions to be dispensed from the dispensers and mixed by flowing the first and second fluid compositions through a static mixer. The first and second fluid compositions are dispensed from the fluid delivery port as a fluid mixture that reacts in situ to form a nonfluent closure composition adjacent the vessel puncture site.