Abstract: Methods and apparatuses for monitoring and regulating physiological states and functions are disclosed. Several embodiments include application of one or more microelectrode arrays to a dorsal root ganglion for measurement of sensory neuron activity, or stimulation of sensory reflex circuits. The methods and apparatuses can be used, for example, for monitoring or controlling bladder function in a patient.

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: In some examples, electrical stimulation therapy is delivered to support obesity management. The electrical stimulation therapy is configured to cause at least partial gastric distention. Gastric distention tends to induce a sensation of fullness and thereby discourages excessive food intake by the patient. The electrical stimulation therapy may be delivered to the gastrointestinal tract of the patient by electrodes deployed by one or more implantable leads coupled to an electrical stimulator. The electrical stimulator delivers stimulation pulses having a pulse width in a range found to be effective in causing gastric distention.

Abstract: Systems and methods for treating at least one of a plurality of disorders characterized at least in part by vagal activity.

Abstract: Systems and methods of using a system for treating a gastrointestinal disorder characterized by dysmotility of a gastrointestinal organ.

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: A therapy system for applying an electrical signal to an internal anatomical feature of a patient includes an implantable component and an external component. The medical device can be checked for safety issues by periodically initiating a sequence of tests of an H-bridge circuit, and, during each test, monitoring a current flow through a sensing resistor electrically connected between a sensing connection of the H-bridge circuit and a ground. Current flow through the sensing resistor indicates that both series electrical switches within at least one of the two pairs of series electrical switches are active during that test.

Abstract: Various implantable medical device embodiments stimulate an autonomic neural target from within a pulmonary artery, and comprise at least one electrode, a power supply, a neural stimulator connected to the power supply, and an anchor structure. The neural stimulator is configured to generate a neural stimulation signal for delivery to the neural stimulation target through the at least one electrode. The anchor structure is configured to chronically and securely implant the neural stimulator, the power supply and the at least one electrode within the pulmonary artery. The anchor structure, the neural stimulator, the power supply and the at least one electrode are configured to be implanted through a pulmonary valve into the pulmonary artery. In various embodiments, the neural stimulator is configured to be operational to implement a neural stimulation protocol when chronically implanted within the pulmonary artery without a wired connection through the pulmonary valve.

Abstract: An exemplary method for treating an eating or metabolism disorder includes calling for delivery of energy to the stomach using a pulse train that includes use of pulses with a pulse width less than approximately 20 ms, a duty cycle greater than approximately 20% and a pulse train duration of less than approximately 10 seconds and calling for delivery of energy to a vagal nerve. Various other methods, devices, systems, etc., are also disclosed.

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 bulimia. The signal may be a blocking or a stimulation signal. In some embodiments, the signal is selected to, at least in part, downregulate neural activity on the vagus nerve.

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: Systems and methods are disclosed to stimulate gastrointestinal tissue to treat medical conditions such as eating disorders, gastroparesis, and gastric reflux. The invention uses electrical stimulation of the nerve, where vibrational energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined gastrointestinal tissue site. The vibrational energy is generated by a controller-transmitter, which could be implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on or around the gastrointestinal tissue that needs to be stimulated. The implantable receiver-stimulator stimulates different gastrointestinal tissue to provide the desired therapeutic benefit.

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: The specification discloses methods and devices for electrically stimulating one or more structures in the gastrointestinal tract. The one or more structures are preferably selected from the upper esophageal sphincter, the esophagus and gastric fundus. The method may involve the step of arranging a plurality of stimulating electrodes adjacent one or more structures which may further include the lower esophageal sphincter, the stomach, the pyloric sphincter, the small intestine, the colon and the vagus. The method and device may further include sensing electrodes to detect change in one or more physiological parameters in the gastrointestinal tract and modulate the stimulating electrodes in response to the change. The device comprises a pulse generator, a power source, a plurality of stimulating electrode set, one or more sensing electrodes and means for varying activity of the stimulating electrodes in response to change detected in the gastrointestinal tract.

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: 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: 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: 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: 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 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 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 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 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: 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: 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.