Abstract: The disclosure provides a method of treatment for obesity, in an individual in need thereof, by administering electrical stimulation at dual sites in the gastrointestinal tract. The electrical stimulations are administered by positioning bipolar stimulatory electrodes in contact with the gastric and dudenol cavities, along afferent vagal neural pathways, in the gastrointestinal tract. The electrical stimulations thus administered, activate the vagal afferents associated with the gastric and dudenol sites in the gastrointestinal tract. The activation of vagal afferents modulates the gastrointestinal peptide satiety hormones. Further, the disclosure provides a method of treatment for eating disorders, in an individual in need thereof, by administering electrical stimulation at dual sites, along afferent vagal neural pathways, in the gastrointestinal tract.

Abstract: The present invention is directed to a method of stimulating the vagus nerve of a subject.

Abstract: The present invention involves a method and a system for using electrical stimulation to treat gastrointestinal and/or eating disorders. More particularly, the method comprises surgically implanting an electrical stimulation lead that is in communication with predetermined thoracic vertebral segments to cause spinal nervous tissue stimulation, thus treating a wide variety of gastrointestinal disorders.

Abstract: Apparatus (450) is provided including an electrode (460) and an implantation tool (458) configured to be passed into an abdominal cavity of a patient, and to insert the electrode into a gastric wall of the patient, generally in parallel to the gastric wall. Other embodiments are also described.

Abstract: A therapeutic waveform for neurophysiologic treatment of conditions associated with function of ionic channels of beta cells of the pancreas includes a positive part having a pulse width of 40 to 60 milliseconds having a positively pointing segment, and includes a negative part dropping sharply negatively following the positive part. The negative drop is 75 to 90 percent of the peak-to-peak voltage of the waveform at about 10 to 100 volts AC. A negative spike-like first aspect of the negative part exhibits a pulse width of 40 to 60 milliseconds but afterwards gradually approaches a neutral voltage level of the waveform. The first aspect of the negative part of the waveform is followed by a second aspect which more slowly approaches the neutral level over a period of 100 to 200 milliseconds, before the next waveform. The current of the waveform is 300 to 1000 micro-amperes.

Abstract: A small implantable stimulator(s) having at least two electrodes is implanted adjacent to a gastrointestinal nerve and/or muscle for the stimulation treatment of gastrointestinal disorders, including gastrointestinal motility, sphincteric disorders, and/or eating disorders. The stimulator provides a means of stimulating tissue at a stimulation site when desired, and may be implanted via a minimal surgical procedure.

Abstract: Devices, systems and methods are disclosed for treating or preventing gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve. The methods provide damaged interstitial cells of Cajal (ICC) with trophic factors via vagal afferent nerve fibers, thereby reversing ICC damage, and as a consequence improving gastric motility. The methods also increase levels of inhibitory neurotransmitters in the brain so as to decrease neural activity within the area postrema, or they deactivate a resting state neural network containing parts of the anterior insula and anterior cingulate cortex, which will thereby reduce abnormal interoception and visceral hypersensitivity.

Abstract: The present specification discloses devices and methodologies for the treatment of nocturnal GERD. Individuals with nocturnal GERD may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow and have improved energy storage requirements.

Abstract: The present specification discloses devices and methodologies for the treatment of diurnal GERD. Individuals with GERD may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow and have improved energy storage requirements.

Abstract: The present invention provides a method of affecting physiological disorders by stimulating a specific location along the sympathetic nerve chain. Preferably, the present invention provides a method of affecting a variety of physiological disorders or pathological conditions by placing an electrode adjacent to or in communication with at least one ganglion along the sympathetic nerve chain and stimulating the at least one ganglion until the physiological disorder or pathological condition has been affected.

Abstract: A method for treating an impaired body function in a patient, including the steps of (a) laparoscopically implanting at least one neuroprothesis electrode on a least one endopelvic nerve root of a patient; (b) electrostimulating the nerve root with the electrode for a predetermined time period to induce a body function of the patient; and (c) during the predetermined time period, instructing the patient to mentally concentrate on performing the body function.

Abstract: Apparatus (18, 18?) is provided, which includes one or more fundic sensors (74), configured to be applied to a fundus of a subject (10), and to generate a fundic signal. The apparatus further includes a control unit (90), which is configured to make a tentative determination of ingestion by the subject (10), determine fundic impedance responsively to the fundic signal, and calculate a duration of a period during which the fundic impedance rose during the tentatively-determined ingestion. Upon finding that the duration is less than a fundic rise duration threshold value, the control unit (90) determines that the tentative determination of ingestion is a false positive. Other embodiments are also described.

Abstract: A device and method is provided for treating treat gastrointestinal disorders using electrical stimulation. In one advantageous form, the method uses mucosal EGG (mEGG) to analyze a patient's natural gastric electrical activity. The mEGG can be measured anywhere in the gastrointestinal tract. From the mEGG, one can determine whether a patient is a good candidate for gastrointestinal electrical stimulation. For example, analysis of the frequency, amplitude and a ratio of frequency to amplitude can be used to determine who should receive gastrointestinal electrical stimulation, and at what the various stimulation parameters should be. The present method can be used to treat various disorders relating to gastrointestinal electrical activity. Ideally, the gastric electrical stimulation is delivered at a desired frequency and amplitude to effectuate normalization of gastric electrical current/activity, thereby treating disorders associated with gastric electrical activity.

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 embodiments of an implant system are provided. The implant, such as a mesh implant, can include a support structure, e.g., mesh sling or implant, one or more stimulation elements (e.g., leads), and an energizing element. Leads or electrodes can be positioned in desired stimulation zones of the implant. As such, the implant can include multiple electrically isolated mesh electrode pads or regions.

Abstract: Methods and devices for creating and/or adding to sensations of satiety to reduce food intake. Methods include electrically stimulating the duodenum which may induce false nerve signals in the duodenal region which are normally indicative of duodenal distension (fullness) and/or the presence of food in the duodenum. The artificially generated signals may be applied in a pattern which mimics at least in part a naturally occurring pattern of duodenal signals generated responsive to eating a meal. Some artificial patterns may be exaggerated relative to the natural patterns, by occurring earlier after ingestion, and/or lasting longer after ingestion, having an exaggerated (higher) frequency response or a faster rate of frequency increase after ingestion. The applied signals may generate nerve signals going to the brain which induce a feeling of satiety.

Abstract: The present specification discloses devices and methodologies for the treatment of GERD. Individuals with GERD may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow, have improved energy storage requirements, enable improved LES function while concurrently delivering additional health benefits, and enable improved LES function post stimulation termination.

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 an electrode on a vagus nerve. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. In some embodiments, the disorder is gastroparesis. The signal may be a blocking or a stimulation signal. In some embodiments, the signal is selected to a) at least in part, upregulate neural activity on the vagus nerve without triggering muscular contractility, and, b) increase pancreobilliary output.

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: A method for altering operation of a nerve related to a given body condition includes the steps of identifying at least one nerve root of a nerve related to the given body condition; laparoscopically implanting at least one electrode on the nerve root; and operating the electrode to electrostimulate the nerve root and alter operation of the nerve.

Abstract: Systems for stimulating one or more esophageal muscle contractions are provided. The systems, which are designed to evoke esophageal motion to promote the downward movement of material, include an elongated member for placement in a patient's esophagus and at least one mechanical or electrical stimulator coupled to the elongated member. Methods for stimulating and contracting an esophageal muscle using electrodes and a generated signal sequence are also provided.

Abstract: Provided herein are methods and devices useful for inhibiting or treating urological conditions, such as overactive bladder (OAB) symptoms including bladder overactivity, urinary frequency, urinary urgency, urinary incontinence, interstitial cystitis (IC), urinary retention, and pelvic pain; gastrointestinal conditions, such as fecal incontinence, irritable bowel syndrome (IBS), and constipation; and sexual conditions, such as premature ejaculation, erectile disorder, and female sexual arousal disorder by non-invasive transcutaneous electrical stimulation of the foot.

Abstract: The evoked spinal cord potential monitoring apparatus of the present invention includes: a pair of electrodes 14; and a holding section 12 for holding the pair of electrodes 14, a tip section of each of the electrodes 14 being extended outwards from an end of the holding section 12, and the electrodes 14 being movable relative to the holding section 12. A hook section 15 engageable to an intercostal nerve is provided at the tip section of each of the electrodes 14, and the electrodes 14 or the holding section 12 is moved while the hook section 15 is coupled to the intercostal nerve such that the hook section 15 and the holding section 12 are able to hold the intercostal nerve therebetween. The apparatus requires no preoperative preparation, is capable of coping with an emergency case, and further, is unsusceptible to the influence of anesthetics.

Abstract: A pancreatic controller, comprising: a glucose sensor, for sensing a level of glucose or insulin in a body serum; at least one electrode, for electrifying an insulin producing cell or group of cells; a power source for electrifying said electrode with a pulse that does not initiate an action potential in said cell and has an effect of increasing insulin secretion; and a controller which receives the sensed level and controls said power source to electrify said electrode to have a desired effect on said level.

Abstract: Methods and devices for improved neurostimulation to treat obesity. Some methods include measuring temperature increases in Brown Adipose Tissue (BAT) during intraoperative test stimulations to determine the proper nerve electrode placement for implantation. Methods can include determining the side of the patient having the most BAT, and stimulating preferentially on that right or left side. The BAT maybe used to burn fat by stimulating the sympathetic nervous system innervating the BAT deposits.

Abstract: Medical, diagnostic, and/or patient monitoring methods, systems and devices enhance ingestion-related health, often by screening and/or treating patients with eating disorders. Optionally, a gastric electric stimulation (GES) therapy system monitors changes in an obese patients' autonomic balance associated with a stimulation event and/or a meal event by analyzing heart rate variability (HRV) of the patient. These event-based changes in autonomic balance may be used to determine which patients will likely respond to GES therapy, and/or to control the GES therapy administration.

Abstract: A method of preventing acute pancreatitis comprising positioning stimulatory electrodes in the stomach of an individual in need thereof; and administering repetitive trains of short pulse gastrointestinal electrical stimulation effective for suppressing the inflammatory response in the pancreas is provided herein. The electrodes are placed by laproscopic, endoscopic or surgical means. The gastrointestinal stimulation activates vagal reflexes. The activation of the vagal reflexes is via the gastric and pancreatic afferents. The gastrointestinal stimulation also activates the axonal reflexes. The activation of the axonal reflexes is via the dichotomous branches of the spinal nerves. The electrical stimulation is administered concurrently with an endoscopic procedure or immediately following an endoscopic procedure.

Abstract: Methods and devices for delivering electrical stimulation to the sympathetic nervous system in response to the onset of eating. In some methods, swallowing is detected which then initiates a dose of stimulation which can vary in intensity, frequency, or both over the dose length. In some methods, the dose length is between about one quarter hour and one hour. The dose frequency may increase, hold steady, then decrease over the dose duration so as to mimic the response of the gut stretch and nutrient receptors to receiving food. The dose can drive biomarkers indicative of eating, for example glucagon, glucose, FFA or glycerol to at least about half of their normal post eating levels and then stop so as to retain stimulation effectiveness for subsequent doses and to prolong battery life.

Abstract: Described herein are methods and systems for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation. In particular, described herein are single supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >4 hours, greater than 12 hours, greater than 24 hours, greater than 48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation. These methods and devices are particularly of interest in treatment of inflammatory bowel disease (IBD).

Abstract: In some examples, the disclosure relates to a systems, devices, and techniques for monitoring the occurrence of food intake by a patient. In one example, the disclosure relates to a method including determining a phase of tissue impedance at one or more gastrointestinal tract locations of a patient via a medical device, and determining the occurrence of food intake by the patient based on the determined phase of the tissue impedance. In some examples, a medical device may control the delivery of therapy to a patient based on the determination of food intake based on the phase to the tissue impedance.

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: A method is provided, including physically contacting a gastric implantation site of a stomach via a transluminal approach, physically contacting the site via a transabdominal approach, stabilizing the site, and implanting an electrode at the site based on the physical contact provided by the transluminal and transabdominal approach. Other embodiments are also described.

Abstract: A time series data analyzer includes a segment condition input section, an analysis condition input section, and an optimum condition deriving section for analyzing all segments based on the segment conditions and analysis conditions inputted in the respective input sections, under all analysis conditions by a maximum entropy method and a nonlinear least squares method. The time series data analyzer derives the optimum segment length and the optimum lag value in correspondence to selected results, and an analysis execution section executes analysis by the maximum entropy method by setting the optimum analysis conditions derived as described above. The trending of the spectrum of electroencephalogram data is used as an indicator of the state of the subject based on the findings that the spectrum of electroencephalogram data is an exponential spectrum and the gradient changes depending on the state of the subject.

Abstract: A method is provided for treating a subject. The method includes administering to the subject an ingestible capsule containing one or more flexible support elements adapted to expand while in a stomach of the subject, thereby bringing a plurality of electrodes into contact with a wall of the stomach. The method also includes driving the electrodes to apply an electrical signal to the stomach wall at first and second times, the second time at last 24 hours after the first time. Other embodiments are also described.

Abstract: Systems and methods for treating gastroesophageal reflux disease (GERD) includes minimally invasively implanting a stimulating device in a patient's esophagus in the region proximate the lower esophageal sphincter (LES). The patient is provided with a questionnaire related to his disease via an online service. The questionnaire is accessed on a mobile device, such as a cell phone, or on a computer with network access. The data from the sensors and the answers from the questionnaire are analyzed together by a health care provider using the online service. The data and answers are used to program the stimulating device, via the mobile device or computer, to optimize treatment.

Abstract: The present invention involves a method and a system for using electrical stimulation to treat gastrointestinal and/or eating disorders. More particularly, the method comprises surgically implanting an electrical stimulation lead that is in communication with predetermined thoracic vertebral segments to cause spinal nervous tissue stimulation, thus treating a wide variety of gastrointestinal disorders.

Abstract: An implantable stimulator(s), small enough to be located near or adjacent to an autonomic nerve(s) innervating urinary and/or gastrointestinal structures, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, if necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.

Abstract: A device is provided for stimulating select body tissues and organs from within a compartment in a body. The device includes a tube having a distal end, a proximal end and a plurality of lumens. At least one distendable element is located along and coupled to the tube in closer proximity to the distal end than to the proximal end. Each distendable element is configured to expand against the compartment into a first position and contract within the compartment into a second position. At least one electrical component is in association with each of the distendable elements and configured to activate and deactivate electrical stimulation to the select body tissues and organs. The expansion and contraction of each distendable element and the activation and deactivation of each electrical component in the compartment is repeated over a period of time.

Abstract: Assessing decongestive therapy delivered to a heart failure patient involves use of an implantable sensor configured to sense a physiologic parameter indicative of the patient's diuresis status and a processor coupled to the implantable sensor. The sensor may comprise a thoracic fluid sensor, a heart sounds sensor, a cardiac chamber or arterial pressure sensor, a respiration sensor, or a blood chemistry sensor, for example. The processor is configured to determine if a target level of patient diuresis has been achieved based on a relationship between the sensed physiologic parameter and a threshold developed for the patient, and to produce an output in response to determining that the target level of patient diuresis has been achieved. The processor may be disposed in an implantable housing, in a patient-external housing, or in a network server system.

Abstract: The present specification describes methods and devices using electrical stimulation to modulate lower esophageal sphincter (LES) pressure. The electrical stimulation may be delivered to the LES via one or more electrodes that is placed in contact with the LES tissue. The methods and devices are useful to treat a number of conditions or disease conditions, including for example, gastroesophageal reflux disease (GERD).

Abstract: Apparatus is provided, including a control unit (310), adapted to be implanted within a patient (324), and a corkscrew-shaped electrode mount (400), adapted to be implanted in a wall of a stomach of the patient. The corkscrew-shaped electrode mount includes first (404) and second (424) electrodes, at respective sites of the electrode mount, and a controller (420), wirelessly coupled to the control unit. Other embodiments are also described.

Abstract: Some embodiments relate to a method of treating a waste evacuation dysfunction, comprising administering transcutaneous electrical stimulation to at least one lumbar or abdominal region for at least one treatment period per day over a treatment term of at least one week.

Abstract: The invention relates to a stimulation electrode for a stimulation device for stimulating organs in the case of spinal paraplegia, more particularly in the case of detrusor sphincter dyssynergia, including an electrode shaft, at one end of which an electrode tip is arranged for emitting a stimulation signal and at the other end of which a connection region is provided for a signal line, and also at least one fixing mechanism for fixing the position of the electrode shaft in the surrounding tissue along the longitudinal axis of said electrode shaft, fixing mechanism having at least one holding member preventing a withdrawal and at least one holding member preventing an advance.

Abstract: An implant device comprising an electrode for electrical stimulation of the pancreas, the device being adapted to be inserted into the pancreas, and to change at least one of its properties after being inserted into the pancreas, so that it will cause less irritation to the pancreas than before changing said property.

Abstract: A cell stimulating and measuring device which contains a larger number of electrodes than used in current stimulators and measuring devices. The larger number of electrodes is possible with the implementation of an addressing system to choose one or a plurality of electrodes from a larger set of available electrodes to be active. Moreover, the digital address and control lines passing from the battery/control electronics unit, to the stimulator and measuring device which contains the electrodes, are sent in serial form, which decreases the space used by the wires that must be minimized in a device implanted in a living organism. The system can be used to send current to electrically stimulate cells, and to connect the same, or other electrodes to a measuring unit for data collection, which can be used either for clinical or for research use.

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 in an embodiment of 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.

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: In general, the disclosure is directed to devices, systems, and techniques for delivering electrical stimulation to a patient with varying pulse frequencies within each burst of pulses. The pulse frequency variation within each burst of pulses may be between approximately 20 Hz and 40 Hz. In some examples, the pulse frequency may be increased, decreased, or polynomially varied within each burst. In other examples, the frequency of intrinsic nerve impulses may be detected and used to deliver pulses with the detected frequency or an inverse of the detected frequency. Electrical stimulation therapy with intra-burst pulse frequency variation may alleviate bladder dysfunction, bowel dysfunction, pain or other disorders.

Abstract: An implantable restriction system having an antenna capable of being readily and predictably movable to achieve a desired orientation that is effective to communicate with an external device is provided. The antenna can be movably coupled to a housing such that the antenna can float and/or move freely with respect to the housing. The housing can be part of a gimbal element or another component of the system. The antenna can include a weight or a magnetic element to help it achieve the desired orientation. Methods for transcutaneously communicating with an implantable restriction device are also provided.

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.