Abstract:
Devices and methods for ablating tissue in the wall of various organs of the gastrointestinal tract of a patient in order to cure or ameliorate metabolic pathophysiological conditions such as obesity, insulin resistance, or type 2 diabetes mellitus are provided. Ablational treatment of target areas may be fractional or partial, rendering a post-treatment portion of target tissue ablated and another portion that is substantially intact. Fractional ablation is achieved by controlling the delivery of ablational energy across the surface area being treated, and controlling the depth of energy penetration into tissue. Surface area control of energy delivery may controlled by the spatial pattern of distributed ablation elements or by the selective activation of a subset of a dense pattern of ablation elements. Embodiments of the device include an ablational electrode array that spans 360 degrees and an array that spans an arc of less than 360 degrees.
Abstract:
A targeted tissue region in a body is treated by a tissue heating element attached to a carrier. The carrier is intended, in use, to be temporarily mounted to an exterior of a catheter body, such as an endoscope. The catheter body is deployed, with the carrier mounted on it, into the targeted tissue region. The tissue heating element is operated, e.g., to form one or more tissue lesions, after which the catheter body is retrieved from the targeted tissue region. The carrier can then be removed from the catheter body, allowing the catheter body to be subsequently used for another purpose.
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:
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:
Systems and methods are provided for positioning and stabilizing an external instrument during insertion of the instrument through the oral cavity (e.g., insertion of a catheter through the oral cavity and into the esophagus or cardia for treatment of gastroesophageal reflux disease (GERD)). The systems and methods provide a gripping tool for association with a bite block, capable of selectively moving between an open position in which the instrument may be inserted or removed, and a closed position in which the external instrument is held in a fixed position.
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:
Systems and methods are provided for positioning and stabilizing an external instrument during insertion of the instrument through the oral cavity (e.g., insertion of a catheter through the oral cavity and into the esophagus or cardia for treatment of gastroesophageal reflux disease (GERD)). The systems and methods provide a gripping tool for association with a bite block, capable of selectively moving between an open position in which the instrument may be inserted or removed, and a closed position in which the external instrument is held in a fixed position.
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.
Abstract:
Systems and methods affect tightening of the pyloric sphincter and/or serve to mediate or moderate receptive relaxation of muscles in the stomach, to treat or mitigate various physiologic conditions, such as obesity, biliary reflex, GERD, and/or Barrett's esophagus. The systems and methods may be used as either a primary treatment modality, or applied as a supplementary treatment before, during or after a primary intervention.
Abstract:
Devices and methods are provided for ablating areas of the gastrointestinal tract affected with certain benign, pre-cancerous, or early cancerous lesions that originate within the epithelium and are limited to the mucosal layer of the gastrointestinal tract wall. Examples of such lesions include benign conditions such as cervical inlet patch (ectopic gastric mucosa in the upper esophagus), as well as pre-cancerous and cancerous conditions such as intestinal metaplasia/intra-epithelial neoplasia/early cancer of the stomach, squamous intra-epithelial neoplasia and early cancer of the esophagus, oral and pharyngeal leukoplakia, flat colonic polyps, anal intra-epithelial neoplasia (AIN), and early cancers of the anal canal. Ablation, as provided the invention, commences at the epithelial layer of the gastrointestinal wall and penetrates deeper into the gastrointestinal wall in a controlled manner to achieve a successful patient outcome, the latter of which is defined generally as eradication of the targeted lesion, and/or a change in the targeted lesion to prevent or forestall patient morbidity. Embodiments of the device include an ablational electrode array that spans 360 degrees and an array that spans an arc of less than 360 degrees.