Abstract: A responsive gastrointestinal stimulation device is provided where one or more sensors sense data corresponding to a subject or the gastrointestinal tract of a subject and responds to sensing the data by stimulating, adjusting stimulation, or stopping stimulation of the gastrointestinal tract. A stimulation device is also provided to stimulate the gastrointestinal tract to produce a sensation of satiety or to control hunger or food consumption.

Abstract: An apparatus for applying a signal to a nerve for the treatment of a disorder includes a first electrode and a second electrode. Each of the electrodes is adapted to be secured to a nerve of a patient. A signal generator is electrically connected to each of the first and second electrodes. The signal generator is adapted to create a signal having a first waveform at the first electrode and a second waveform at the second electrode. The waveforms have parameters selected to block propagation of neural action potentials. The waveforms have a repeating pattern of cycles of pulses with a delay period between at least selected ones of said pulses. In one embodiment, the first and second waveforms are out of phase for a cycle of one of the waveforms to occur during a delay period of the other of the waveforms.

Abstract: At least one of a plurality of disorders of a patient characterized at least in part by vagal activity innervating at least one of a plurality of organs of the patient is treated by a method that includes positioning a neurostimulator carrier around a body organ of the patient where the organ is innervated by at least a vagal trunk. An electrode is disposed on the carrier and positioned at the vagal trunk. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. The signal may be a blocking or a stimulation signal.

Abstract: A pseudounipolar stimulator lead for anchoring to a digestive organ is provided.

Abstract: Method and apparatus for treating obesity by use of transesophageal delivery of energy to interrupt the function of vagal nerves. The energy, which may be highly focused ultrasound energy or other types of energy is delivered through the wall of the esophagus by a device placed in the esophagus. The energy delivered is sufficient to ablate a vagal nerve on the outer wall of the esophagus.

Abstract: A fixation device for holding stimulating electrodes in electrical contact with the wall of a portion of the gastrointestinal tract is provided. The fixation device includes an expandable member that fixes the electrodes in electrical contact with the gastrointestinal tract wall.

Abstract: An apparatus for applying a signal to a nerve for the treatment of a disorder includes a first electrode and a second electrode. Each of the electrodes is adapted to be secured to a nerve of a patient. A signal generator is electrically connected to each of the first and second electrodes. The signal generator is adapted to create a signal having a first waveform at the first electrode and a second waveform at the second electrode. The waveforms have parameters selected to block propagation of neural action potentials. The waveforms have a repeating pattern of cycles of pulses with a delay period between at least selected ones of said pulses. In one embodiment, the first and second waveforms are out of phase for a cycle of one of the waveforms to occur during a delay period of the other of the waveforms.

Abstract: An exemplary method for treating obesity includes calling for delivery of electrical energy to a vagal nerve, detecting pre-prandial activity and, in response to the detection of pre-prandial activity, calling for delivery of electrical energy to the stomach for a pre-determined amount of time to induce satiety. Various other technologies are also disclosed.

Abstract: A method is provided for treating a subject, including applying a current to a site of the subject selected from the list consisting of: a vagus nerve of the subject, an epicardial fat pad of the subject, a pulmonary vein of the subject, a carotid artery of the subject, a carotid sinus of the subject, a vena cava vein of the subject, and an internal jugular vein of the subject.

Abstract: Systems and methods are provided for modulating the autonomic nervous system by the electrical stimulation of the neuro-muscular system of a patient, and include an implantable electrical system for gastrointestinal stimulation which incorporates a heart rate sensor to indicate the neurovegetative patient condition, to initiate and terminate stimulation at specific locations, and an algorithm to automatically control electrical stimulation frequency, interval, amplitude, or a combination of such parameters for adaptive treatment of obesity, anorexia, other eating disorders, diseases related with the so called “metabolic syndrome” (e.g., impaired glucose tolerance and diabetes type 2, GERD, systemic hypertension, early arterovascular degeneration, early senility, and the like), and disorders related to a pathologic imbalance of the autonomic nervous system.

Abstract: A device, system and method for stimulating a digestive organ is provided where the stimulation is randomized.

Abstract: Devices and methods are provided for electrically stimulating a predetermined body part of a mammal. The method includes placing at least one electrode in proximity to the mammal's skin, injecting an electrically conductive gel into the body of the mammal so as to form a conductive gel pathway extending at least partially along a distance between the at least one electrode and the predetermined body part, and stimulating the predetermined body part by applying an electrical signal via the electrode that travels, at least in part, through the conductive gel pathway.

Abstract: A method and system for selective inhibition of somatic nerve fibers in a mixed nerve containing both somatic and autonomic nerve fibers where the method finds use in treatment of chronic pain, spastic muscles and for sensory and motor control of a bladder. The methods and systems utilize alternate phase rectangular electrical pulses. An electrical pulse generator is coupled to a nerve. An alternate phase high frequency, low amplitude pulse is first applied to selectively inhibit somatic nerves when present in a mixed nerve. An alternate phase low frequency, high amplitude phase pulse subsequently supplied to stimulate the autonomic nerve fibers and in the case of the sacral root will permit a controlled voiding of the bladder and bowel.

Abstract: An retaining device for attaching to a contractile organ such as a digestive tract organ or stomach is provided. One aspect may include a lead for stimulating a digestive organ. The device may be an electrical stimulation device configured to deliver electrical signals to the organ. The device may be implanted in the abdomen using a laparoscopic or other method.

Abstract: Active implantable medical devices (AIMDs) are backfilled with a dielectric fluid to increase the volts per mil dielectric breakdown strength between internal circuit elements. In a method for backfilling the AIMD with dielectric fluid, substantially all air and moisture is evacuated from the AIMD housing prior to backfilling the AIMD housing with a dielectric fluid having a dielectric breakdown strength greater than air, nitrogen or helium. The AIMD is constructed to accommodate volumetric expansion or contraction of the dielectric fluid due to changes of pressure or temperature of the dielectric fluid to maintain integrity of the AIMD.

Abstract: The present invention teaches a method and apparatus for physiological modulation, including neural and gastrointestinal modulation, for the purposes of treating several disorders, including obesity, depression, epilepsy, and diabetes. This includes chronically implanted neural and neuromuscular modulators, used to modulate the afferent neurons of the sympathetic nervous system to induce satiety as well as to modulate the efferent neurons of the sympathetic nervous system to modulate metabolism, including metabolic rate. Furthermore, this includes neuromuscular stimulation of the stomach to effect baseline and intermittent smooth muscle contraction to increase gastric intraluminal pressure, which induces satiety, and stimulate sympathetic afferent fibers, including those in the sympathetic trunk, splanchnic nerves, and greater curvature of the stomach, to augment the perception of satiety.

Abstract: Methods and an apparatus are described for treating at least one of a plurality of disorders of a patient characterized at least in part by vagal activity innervating at least one of a plurality of organs of the patient. Embodiments include a method for treating a patient having a gastro-intestinal disorder having a inflammatory basis, including positioning an electrode on a vagus nerve below a vagal innervation of a heart of the patient, and treating the patient's gastro-intestinal disorder by applying an electrical signal to the electrode, wherein the signal has a frequency of at least 500 Hz and is selected to down-regulate neural activity on the vagus nerve, allow partial restoration of nerve activity upon discontinuation of the electrical signal, and wherein the signal is configured to reduce pancreatic output and biliary output. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. The signal may be blocking or a stimulation signal.

Abstract: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.

Abstract: Systems and methods selectively stimulate components of the pudendal nerve away from the sacral root to evoke desired physiologic responses in persons who lack the ability to otherwise produce these responses—e.g., maintain continence and/or produce micturition, and/or provide male/female sexuality responses, and/or provide bowel responses. The systems and methods use a multiple electrode array, or individual electrodes, placed on, in, or near the pudendal nerve. The electrode array, or individual electrodes, in association with a pulse generator, provide selective stimulation of individual fascicles within the pudendal nerve, to achieve different physiologic responses.

Abstract: A gastro-electric stimulation system includes an INS for producing an 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 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 decrease the amount of gastric acid produced thereby.

Abstract: Methods and systems of treating a patient having an eating disorder involving coupling at least one electrode to at least one cranial nerve of the patient, implanting a sensory stimulation device in the patient, applying a sensory stimulus to the patient using the sensory stimulation device, detecting the patient's response to the sensory stimulus, and applying an electrical signal to the cranial nerve using the electrode after detecting the response to treat the eating disorder. The methods and systems are effective in treating bulimia.

Abstract: A selection of parameter configurations for a neurostimulator using decision trees may be employed by a programming device to allow a clinician or other user to select parameter configurations, and then program an implantable neurostimulator to deliver therapy using the selected parameter configurations. The programming device executes a parameter configuration search algorithm to guide the clinician in selection of parameter configurations. The search algorithm relies on a decision tree to identify optimum parameter configurations. A decision tree is useful in classifying observations in a data set based upon one or more attributes or fields within the data. The data set includes parameter configurations matched with observed ratings of efficacy on patients of a similar indication. The learned attribute, on which classification occurs, will be the optimum parameter configuration for a set of rated configurations used to produce the classification.

Abstract: A device, system and method for stimulating a digestive organ is provided where the stimulation is randomized.

Abstract: A device (20) for treating a medical condition is provided, and a surgical procedure for implanting the device is disclosed. The device (20) includes a sensor (44), which is adapted to generate a signal responsive to a state of a patient, and at least one electrode (27), which is adapted to be coupled to a pelvic site of the patient. A control unit (22) is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode (27). In various configurations, the device (20) may be used alternatively or additionally to treat fecal incontinence, interstitial cystitis, chronic pelvic pain, or urine retention.

Abstract: A method for treating at least one of a plurality of disorders characterized at least in part by vagal activity includes positioning an electrode at a body organ innervated by the vagus. An electrical signal is applied to the electrode to modulate vagal activity. The electrical signal is applied at a frequency in excess of 3,000 Hz for the signal to create a neural conduction block to the vagus with the neural conduction block selected to at least partially block nerve impulses on the vagus.

Abstract: A method of controlling obesity by injecting bio-compatible bulking material into the pyloric sphincter area of the stomach. The injection of this material bulks the pyloric sphincter, retarding stomach emptying and producing a feeling of satiation in the patient. The method may be supplemental and augmented by inducing flaccid paralysis of the stomach by injecting botulinum toxin into the muscle tissue of the antrum or fundus of the stomach.

Abstract: An implantable stimulation device for use in stimulation based treatments for diseases such as GERD or obesity is described. The device is provided with an anchoring unit which upon deployment assumes a shape optimized for the site of deployment. Sensing electrodes and stimulating electrodes in the device are also designed to assume a suitable shape upon deployment. A novel catheter is also provided for easy and expeditious deployment of the device.

Abstract: The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue. A device is provided having an enclosure within an outer wall formed from an electrically-permeable material to allow for electrical energy to pass from the interior of the enclosure through the outer wall. The device further includes an electrode positioned within the interior of the enclosure and a fluid passage coupled to the enclosure for delivery of an electrically conductive fluid into the interior of the enclosure such that the electrically conductive fluid couples the electrode with the electrically-permeable section of the outer wall. The conductive fluid allows for the passage of electrical energy from the electrode through the fluid and the outer wall of the enclosure for treatment of tissue on or in a patient.

Abstract: Various methods and apparatus for treating a condition associated with impaired glucose regulation in a subject comprising in one embodiment, applying a neural conduction block to a target nerve at a blocking site with the neural conduction block selected to at least partially block nerve pulses. In another embodiment, combinations of down-regulating and or up-regulating with or without pharmaceutical agents are used to treat impaired glucose regulation. In other embodiments, up-regulation or down-regulation of various nerves, such as the vagus and its branches, and the splanchnic is used to modify the production of GLP-1 and GIP, thereby controlling glucose levels. In yet further embodiments, combinations of down-regulating and or up-regulating with or without pharmaceutical agents are used to modify the production of GLP-1 and GIP, to treat impaired glucose regulation.

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: An implantable medical device system advantageously utilizes low frequency (e.g., about 1-100 kHz) transcutaneous energy transfer (TET) for supplying power from an external control module to an implantable medical device, avoiding power dissipation through eddy currents in a metallic case of an implant and/or in human tissue, thereby enabling smaller implants using a metallic case such as titanium and/or allowing TET signals of greater strength thereby allowing placement more deeply within a patient without excessive power transfer inefficiencies.

Abstract: There is provided a method for controlling a flow of intestinal contents in the intestinal passageway of a patient's intestines. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the intestinal tissue wall) at least one portion of the intestinal tissue wall to influence the flow in the intestinal passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the intestinal passageway. The method can be used for restricting or stopping the flow in the intestinal passageway, or for actively moving the fluid in the intestinal passageway, with a low risk of injuring the intestines.

Abstract: Systems and methods are disclosed for treatment of metabolic disorders such as type 2 diabetes and obesity by stimulation of the small intestine to modulate hormone production. Methods include applying an appropriate signal to a region of the small intestine to modulate hormone production. The method may involve applying a signal to the nerves that innervate the small intestine. Devices for delivering the signal are disclosed.

Abstract: A method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient?s stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals. An endoscopic delivery system delivers the functional device through the esophagus and into the stomach where it is attached the stomach wall.

Abstract: Various methods and devices are provided for aligning an internal antenna with an external device. In one embodiment, an implantable restriction system is provided and includes an implantable restriction device configured to form a restriction in a pathway, and an implantable housing associated with the implantable restriction device. The housing has at least one antenna that can be configured to communicate telemetrically with a transceiver regardless of a rotational orientation of the housing about an axis. The at least one antenna can extend along an axis aligned with the longitudinal axis of a catheter extending from the housing. In one embodiment, the implantable housing can contain a sensor that can be configured, for example, to measure at least one of a system parameter and a physiological parameter, and the antenna can be effective to communicate the measured parameter to the transceiver.

Abstract: A device, system and method for anchoring a device to a stomach is provided. The device may be, among other things, a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The anchor of the device is constructed to resist pull out forces. An anchor has an optimal weight to surface area ratio.

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: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate fecal or urinary incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: A device for controlling food intake including a band, is configured to be placed around the stomach of a patient, dividing the stomach into lower and upper pouches. At least one sensor, located on the band detects pressure against the band caused by food ingestion collected in the upper pouch. A controller is coupled to the senor for receiving signals from the sensor for comparison against a predefined threshold. At least one electrode is coupled to the controller and the stomach, where the controller, upon the detection of pressure in the sensor above the pre-defined threshold, generates an electronic interference signal to the stomach of the patient.

Abstract: A system and method are provided for transducing vaginal conditions, affecting vaginal or body conditions, and/or stimulating perineal musculature and nerves. A separate, portable, non-implanted intravaginally containable combination probe and transceiver is provided that can sense vaginal conditions, can deliver signals or medication, and/or can stimulate perineal musculature and nerves. This probe unit is provided with 2-way wireless communication for transmitting information that is transduced and for receiving control and programming signals. In addition, a separate combination controller and transceiver is provided for wirelessly sending signals to the probe unit and for receiving signals therefrom. A real time wireless signal feedback loop is thus provided between the controller and the probe and/or external devices, networks and databases.

Abstract: A neurostimulation kit and a method of treating a patient are provided. The kit comprises a stimulation backing that includes a flat, electrically insulative, body having a pair of opposing first and second planar surfaces, and an electrode affixed to the first surface of the insulative body. The stimulation backing is implanted within a patient and affixed therein to place the electrode into contact with a tissue surface. The kit comprises a neurostimulator including a housing and stimulation circuitry contained within the housing. The neurostimulator is implanted within the patient by affixing the housing to the second surface of the insulative body, such that the stimulation circuitry is electrically coupled to the electrode.

Abstract: We disclose a method of treating a medical condition in a patient using an implantable medical device including coupling at least a first electrode and a second electrode to a cranial nerve of the patient, providing a programmable electrical signal generator coupled to the first electrode and the second electrode, generating a first electrical signal with the electrical signal generator, applying the first electrical signal to the electrodes, wherein the first electrode is a cathode and the second electrode is an anode, reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is an anode and the second electrode is a cathode, generating a second electrical signal with the electrical signal generator, applying the second electrical signal to the electrodes, reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is a cathode and the second electrode is an anode, generating a

Abstract: Methods and systems of treating a patient with pancreatitis pain include providing a stimulator, configuring one or more stimulation parameters to control sphincter of Oddi function, programming the stimulator with the one or more stimulation parameters, generating a stimulus configured to control sphincter of Oddi function with the stimulator in accordance with the one or more stimulation parameters, and applying the stimulus with the stimulator to one or more stimulation sites in accordance with the one or more stimulation parameters.

Abstract: The present invention teaches methods and apparatus for user control and operation of physiological modulation, including neural and gastrointestinal modulation, for the purposes of treating several disorders, including obesity. This includes programming of neuromodulatory signal for the modulation of autonomic neural and neuromuscular modulators, used to modulate tissues, including the afferent neurons of the sympathetic nervous system to induce satiety and efferent neurons to modulate metabolism.

Abstract: Systems and methods treat urinary incontinence by the bilateral stimulation of the left and/or right branches of the dorsal genital nerves using a single lead implanted in adipose or other tissue in the region at or near the pubic symphysis.

Abstract: A method (and associated apparatus) of providing electrical neurostimulation therapy to a patient using an implanted neurostimulator comprises (a) delivering an electrical stimulation to a nerve and (b) determining whether a predetermined condition has occurred as a result of the stimulation. The method further comprises (c) if the predetermined condition has not occurred, adjusting one or more stimulation parameters; and (d) repeating (a), (b), and (c) until the predetermined condition occurs.

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: A method for the treatment of obesity or other disorders by electrical activation or inhibition of the sympathetic nervous system is disclosed. This activation or inhibition can be accomplished by stimulating the greater splanchnic nerve or other portion of the sympathetic nervous system using an electrode. This nerve activation can result in reduced food intake and increased energy expenditure.

Abstract: A method of treating a temporary arrest of intestinal peristalsis includes inducing at least one of an electric current, an electric field and an electromagnetic field in a sympathetic nerve chain of a mammal to block and/or modulate inhibitory nerve signals thereof such that intestinal peristalsis function is at least partially improved.

Abstract: A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals.