Abstract: A stimulation device for electrical stimulation of a target location of a gastrointestinal tract of a patient that includes a device housing sized for introduction into a gastrointestinal tract, wherein the device housing is configured to attach to a connector, an electrical pulse generator, mounted within the device housing, to generate an electrical stimulation waveform, one or more electrodes electrically coupled to the electrical pulse generator and mounted to the device housing to deliver the electrical stimulation waveform to the gastrointestinal tract, and a fixation structure to attach the device housing to the target location of the gastrointestinal tract, wherein the stimulation device is configured to be tethered to an area around the target location using the connector. A method for attaching a stimulation device of the invention to a wall of a gastrointestinal tract is also included.

Abstract: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.

Abstract: The disclosure is directed to gastric stimulation programmers, stimulators and methods for controlling delivery of gastric stimulation therapy to maintain the efficacy of the therapy over time. Maintaining the efficacy of gastric stimulation therapy may be possible by implementing one or more anti-desensitization features in a gastric stimulation controller or stimulator. As electrical stimulation therapy is continuously delivered to a patient, the stimulated tissue may become desensitized to the electrical stimulation therapy such that the beneficial effect of the electrical stimulation is diminished. Once desensitization occurs, the affected tissue may not respond favorably to electrical stimulation therapy. Application of one or more anti-desensitization features to control gastric stimulation therapy may reduce or prevent desensitization and effectively extend the efficacy of the therapy over time.

Abstract: The disclosure is directed to gastric stimulation programmers, stimulators and methods for controlling delivery of gastric stimulation therapy to maintain the efficacy of the therapy over time. Maintaining the efficacy of gastric stimulation therapy may be possible by implementing one or more anti-desensitization features in a gastric stimulation controller or stimulator. As electrical stimulation therapy is continuously delivered to a patient, the stimulated tissue may become desensitized to the electrical stimulation therapy such that the beneficial effect of the electrical stimulation is diminished. Once desensitization occurs, the affected tissue may not respond favorably to electrical stimulation therapy. Application of one or more anti-desensitization features to control gastric stimulation therapy may reduce or prevent desensitization and effectively extend the efficacy of the therapy over time.

Abstract: The disclosure is directed to gastric stimulation programmers, stimulators and methods for controlling delivery of gastric stimulation therapy to maintain the efficacy of the therapy over time. Maintaining the efficacy of gastric stimulation therapy may be possible by implementing one or more anti-desensitization features in a gastric stimulation controller or stimulator. As electrical stimulation therapy is continuously delivered to a patient, the stimulated tissue may become desensitized to the electrical stimulation therapy such that the beneficial effect of the electrical stimulation is diminished. Once desensitization occurs, the affected tissue may not respond favorably to electrical stimulation therapy.

Abstract: The invention is directed toward stimulation of a selected tissue layer. A device is attached to a target tissue by applying vacuum pressure to a vacuum cavity of the device and advancing a needle into tissue within the vacuum cavity. The depth on the vacuum cavity is selected to permit deployment at the selected tissue layer. In one embodiment, the invention is directed toward an implantable medical device comprising a device housing defining a vacuum cavity, and a vacuum port for application of vacuum pressure to draw tissue into the vacuum cavity, an electrode that is movable into the vacuum cavity of the device housing to contact at least a portion of the tissue drawn into the vacuum cavity, and a lead comprising at least one conductor coupled to the electrode.

Abstract: Methods and systems for stimulating a gastrointestinal system and for modifying a stimulation signal based on an indicator of autonomic nervous system function are described. One indicator of autonomic nervous system described is cardiac activity, including heart rate variability. Methods for selecting candidate patients for gastrointestinal stimulation therapy based on an indicator of autonomic nervous system function and methods of treating patients at risk of or suffering from gastrointestinal disorders by modifying therapy based on an indicator of autonomic function are also discussed.

Abstract: In general, the invention is directed to treatment of fecal incontinence by the implantation of one or more bulking prostheses proximate to an anal sphincter. These bulking prostheses, which may include biocompatible hydrogel, are inserted into the tissue near the anus through a small opening in the mucosa. When inserted, the bulking prostheses are in a miniature state. Upon introduction into the body, the devices enter an enlarged state. In their enlarged state, the bulking prostheses supply extra bulk to the tissues proximate to the anal sphincters. With the extra bulk, the patient can exercise voluntary control over the external sphincter to close the anus and maintain fecal continence.

Abstract: The invention provides methods and devices to treat obesity by ablating tissue from an exterior surface of a stomach of a patient. For example, the invention may involve ablation of exterior stomach tissue to alter gastric myoelectric activity or muscle function from the exterior surface of the stomach to produce abnormal gastric peristalsis without damaging the mucosal lining of the stomach. The invention may further provide methods and devices to monitor the gastric myoelectric activity before and after the ablation procedure.

Abstract: The invention provides methods and devices to reduce stomach acid secretion in a patient with a hyper acid condition. For example, the invention may involve ablation of the stomach lining to destroy acid-producing cells. Destroying acid-producing cells may reduce the amount of stomach acid produced and, therefore the amount of acid refluxed in the esophagus. The invention may further provide methods and devices to monitor the esophageal acid level before and after the ablation procedure.

Abstract: In general, an implantable medical device is disclosed for generating and applying an electric stimulation signal to a portion of a patient's gastrointestinal tract to induce symptoms of gastroparesis in the patient without substantially reducing normal stomach motility. The induced symptoms of gastroparesis may reduce a patient's desire to consume large portions of food and thus provide an effective treatment for obesity.

Abstract: In general, the invention is directed to systems and methods for monitoring the gastrointestinal system of a patient. In one embodiment, the invention includes techniques for monitoring the emptying of the patient's stomach. The techniques may employ glucose monitoring, pH monitoring with a consumable sensor, of monitoring the position of a consumable sensor as it exits the stomach. Consumable sensors may be employed to sense conditions, such as temperature or bile concentration, in other segments of the gastrointestinal system. The invention also includes systems for tracking the position of one or more consumable sensors as the sensors transit the gastrointestinal system, and monitoring the conditions sensed by the sensors.

Abstract: Methods and systems for treating patients suffering from eating disorders, e.g. obesity, through the dispensation of a drug by an implantable infusion pump (IIP) delivering drug into the cerebral spinal fluid (CSF) at a site of the intrathecal space in amounts and at times effective to suppress the patient's appetite through interaction of the drug transported through the CSF with receptors in the brain. Delivery of a programmed drug dosage is preferably by one of time-out of programmed time(s) of day, a command received from the patient, or a trigger signal developed from a sensed GI tract signal accompanying peristalsis.

Abstract: A gastro-electric stimulation system comprises a INS for producing a electrical stimulation signal, at least one medical electrical lead, and at least two electrical contacts. The medical electrical lead has a proximal end and a distal end, the proximal end being connected to the INS, the distal end being adapted for placement in or near a patient's stomach or appropriate nerve or nerve portion. The electrodes are disposed near the distal end of the medical electrical lead, and are The electrodes are electrically connected through the medical electrical lead to the INS to receive the electrical stimulation signal and convey such signal to the selected electrode implant position. The electrical stimulation signal is provided in an amount and manner adapted to decrease the pH of the gastric acid in the patient's stomach and/or to decrease the amount of gastric acid produced thereby.

Abstract: A gastro-electric stimulation system comprises a INS for producing a electrical stimulation signal, at least one medical electrical lead, and at least two electrical contacts. The medical electrical lead has a proximal end and a distal end, the proximal end being connected to the INS, the distal end being adapted for placement in or near a patient's stomach or appropriate nerve or nerve portion. The electrodes are disposed near the distal end of the medical electrical lead, and are The electrodes are electrically connected through the medical electrical lead to the INS to receive the electrical stimulation signal and convey such signal to the selected electrode implant position. The electrical stimulation signal is provided in an amount and manner adapted to increase the pH of the gastric acid in the patient's stomach and/or to increase the amount of gastric acid produced thereby.

Abstract: In general, the invention is directed to systems and methods for monitoring the gastrointestinal system of a patient. In one embodiment, the invention includes techniques for monitoring the emptying of the patient's stomach. The techniques may employ glucose monitoring, pH monitoring with a consumable sensor, of monitoring the position of a consumable sensor as it exits the stomach. Consumable sensors may be employed to sense conditions, such as temperature or bile concentration, in other segments of the gastrointestinal system. The invention also includes systems for tracking the position of one or more consumable sensors as the sensors transit the gastrointestinal system, and monitoring the conditions sensed by the sensors.

Abstract: The invention provides methods and devices for ablation of stomach tissue to treat obesity. For example, the invention may involve ablation of mucosal tissue to inhibit ghrelin production, recognized as a root cause of increased appetite. The invention alternatively may involve ablation of sub-mucosal tissue to alter myoelectric activity and thereby induce gastroparesis. As a further alternative, gastric muscle tissue, vagal nerves within the stomach or the pyloric region may be ablated to alter stomach function and thereby induce gastroparesis.

Abstract: A system and method for treating gastro-esophageal reflux disease (GERD) in a patient are disclosed. Electrical stimulation pulses are generated by an implantable neurostimulator and delivered to a portion of a patient's stomach located downstream from the lower esophageal sphincter via an implantable medical electrical lead.

Abstract: Methods and implants for treating patients suffering from eating disorders, particularly obesity, by constricting the size of the pylorus lumen through implantation of bulking agents or devices within the submucosa alongside the muscle layers of the pyloric sphincter to slow stomach emptying or elsewhere in the digestive tract to prolong feelings of satiety and reduce feelings of hunger.

Abstract: Methods and systems for treating patients suffering from eating disorders, e.g. obesity, through the dispensation of a drug by an implantable infusion pump (IIP) delivering drug into the cerebral spinal fluid (CSF) at a site of the intrathecal space in amounts and at times effective to suppress the patient's appetite through interaction of the drug transported through the CSF with receptors in the brain. Delivery of a programmed drug dosage is preferably by one of time-out of programmed time(s) of day, a command received from the patient, or a trigger signal developed from a sensed GI tract signal accompanying peristalsis.