Abstract: A method of treating a wide variety of heretofore considered unrelated ailments comprises delivering electricity through a circuit in the body. The circuit includes at least four nerves leading from at least two of the patient's extremities to various nerve roots adjacent the spinal column. Electrical energy from an electrical interferential therapy device is delivered through electrodes on the extremities adjacent the nerve endings until symptoms of the diagnosed ailment ameliorates. Sending impulses from the periphery to the central nervous system appears to the help the body manufacture various neuropeptides and other chemicals which control the essential basics of the body's health and well being.

Abstract: A system, device, and method for placing a capsule for sensing one or more parameters of a patient by anchoring the capsule to a tissue at a specific site and releasing the capsule from the device, using a single actuator operated during a single motion. As an example, a delivery device may anchor the capsule to the tissue site and release the capsule from the delivery device during a single motion of the actuator. This allows a user to place the capsule by interacting with only a single actuator through one type of motion, thus making delivery of the capsule more reliable and user-friendly.

Abstract: An apparatus that comprises at least one electrode adapted to be placed adjacent to a portion of smooth muscle (200) and a controller for electrifying the electrode with a non-excitatory electric field (210) which does not generate excitation of the smooth muscle. The non-excitatory electric field affects the activity of the smooth muscle in a manner that controls a level of a chemical in the blood stream.

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: Gastric stimulation devices, systems and methods are provided, particularly for stimulating a gastric organ having an internal cavity. Such devices and systems are typically implanted outside of the gastric organ while the environment of the internal cavity is probed and monitored by one or more sensors. The sensor information may be used to affect the stimulation signals provided to the gastric organ by the devices and systems. Such feedback integration assists in providing treatments and stimulation programs that are tailored to the needs of the individual patient.

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: Systems and methods for determining a number of interruptions in a sleep state of a patient attributable to an urge or need to void during a sleep event include monitoring an activity level of the patient. The urge or need to void may be attributable to fecal or urinary incontinence. The patient activity level may be determined with one or more sensors that detect motion and/or one or more sensors that monitor a physiological parameter of the patient that varies as a function of patient activity. In one embodiment, a clinician selects a therapy parameter set for the patient based on the severity of the patient's incontinence. In another embodiment, the number of interruptions in the sleep state is associated with a therapy parameter set that was implemented during the sleep state in order to evaluate the efficacy of the therapy parameter set.

Abstract: Apparatus is provided, including an implantable mechanical support, shaped to support a portion of a urethra of a patient. One or more electrodes are coupled to the mechanical support, so as to contact tissue of the patient when the mechanical support is implanted in the patient. A control unit drives the electrodes to apply a current to the tissue. A method for treating a patient is also provided, including implanting a mechanical support in a position that supports a urethra of a patient. In response to increased pelvic pressure of the patient, a substance stored in a portion of the mechanical support that is not under the urethra is moved to a portion of the mechanical support that is under the urethra. Other embodiments are also described.

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: The disclosure is directed to techniques for delivering electrical stimulation therapy 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: 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: Transcutaneous electrical and magnetic nerve stimulation devices are disclosed, along with methods of treating lower urinary tract disorders using energy that is delivered noninvasively by the devices. The disorders comprise overactive bladder, urge incontinence, stress, incontinence, urge frequency, non-obstructive urinary retention and interstitial cystitis/painful bladder syndrome. In preferred embodiments of the disclosed methods, a posterior tibial nerve of a patient is stimulated non-invasively. Methods are disclosed for selecting protocol parameters for a nerve stimulation session for treating each individual patient, wherein modules of the bladder of the patient are represented as coupled non-linear oscillators.

Abstract: Gastric apparatus (18) is provided, including one or more sensors (70, 72, 74), adapted to generate respective sensor signals responsively to a gastrointestinal (GI) tract physiological parameter of a GI tract of a subject, and an implantable control unit (90), comprising a rechargeable battery and a first set of one or more transducers. The implantable control unit (90) is adapted to receive the sensor signals, using one or more of the transducers of the first set, and transmit data responsively to the sensor signals, using one or more of the transducers of the first set. An external control unit (200), including a power source and a second set of one or more transducers, is adapted to drive the power source to inductively transfer energy via one or more transducers of the second set, so as to recharge the battery, and receive the transmitted data, using one or more transducers of the second set.

Abstract: A desired effect is produced by therapeutically activating tissue at a first site within a patient's body and a corresponding undesired side effect is reduced by blocking activation of tissue or conduction of action potentials at a second site within the patient's body by applying high frequency stimulation and/or direct current pulses at or near the second site. Time-varying DC pulses may be used before or after a high frequency blocking signal. The high frequency stimulation may begin before and continue during the therapeutic activation. The high frequency stimulation may begin with a relatively low amplitude, and the amplitude may be gradually increased. The desired effect may be promotion of micturition or defecation and the undesired side effect may be sphincter contraction.

Abstract: The present invention describes methods and devices using low frequency electrical stimulation or neural high frequency 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 method is provided, including placing first and second electrodes at respective first and second sites of a duodenum of a subject, and activating the electrodes to increase a blood insulin level of the subject. Other embodiments are also described.

Abstract: An apparatus for renal neuromodulation includes an expandable support member having a main body portion for engaging a wall of a blood vessel proximate a renal vasculature and at least one electrode connected with the main body portion. The at least one electrode is arranged to selectively deliver electric current to a desired location where modulation of the sympathetic nervous system is effective to alter renal function. The apparatus further includes an insulative material attached to at least a portion of the main body portion for isolating blood flow through the vessel from the electric current delivered by the at least one electrode.

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: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

Abstract: A gastrointestinal device to be implanted into an animal or human tissue includes an elongated body (1) having a first end and a second end, and at least a first abutting member (2) at the first end of the elongated body (1). The device also includes a second abutting member (2?) at the second end of the elongated body (1), which is flexible. The device further includes at least one electrode (16) and a power supply (11) for supplying current to the electrode (16).

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 around 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 selected 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. The application of the electrical signal is discontinued. The application of the signal and the discontinuing of the signal are repeated with durations of the discontinuing and the application selected to treat the disorder.

Abstract: Presented is a method for quantifying breastfeeding between a mother and a baby, the method including measuring a physiological volume indicative of stomach fullness volume for the baby; setting a signal threshold value of the physiological volume to correspond to a stomach level that is less than or equal to the stomach fullness volume; obtaining an objective measurement of the physiological volume indicative of a level of fullness of the baby's stomach; and providing an indication to the mother when the objective measurement equals or exceeds the signal threshold value. In one embodiment, for instance, the baby's swallows may be recorded for determining the volume of breast milk consumed by the baby.

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 includes acquiring an electroneurogram of the right carotid sinus nerve or the left carotid sinus nerve, analyzing the electroneurogram for at least one of chemosensory information and barosensory information and calling for one or more therapeutic actions based at least in part on the analyzing. Therapeutic actions may aim to treat conditions such as sleep apnea, an increase in metabolic demand, hypoglycemia, hypertension, renal failure, and congestive heart failure. Other exemplary methods, devices, systems, etc., are also disclosed.

Abstract: In general, the disclosure describes techniques for providing conditional electrical stimulation to a patient for pelvic health. An implantable medical device (IMD) may adjust the delivery cycle of the electrical stimulation applied to a patient in response to receiving a delivery cycle parameter associated with one or more of the following: a time in a time schedule, a control device output from a control device, and physiological information from a physiological information sensing device. As an example, the IMD may monitor a status of one or more inputs of the IMD and adjust the delivery cycle of the electrical stimulation applied to the patient based on the status of the input(s).

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: A method is provided, including placing first and second electrodes (90) at respective first and second sites of a duodenum (40) of a subject, and activating the electrodes (90) to increase a blood insulin level of the subject. Other embodiments are also described.

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: A system for designing a therapy or for treating a gastrointestinal disorder or a condition associated with excess weight in a subject comprising at least one electrode configured to be implanted within a body of the patient and placed at a vagus nerve, the electrode also configured to apply therapy to the vagus nerve upon application of a therapy cycle to the electrode; an implantable neuroregulator for placement in the body of the patient beneath the skin layer, the implantable neuroregulator being configured to generate a therapy cycle, wherein the therapy cycle comprises an on time during which an electrical signal is delivered, the electrical signal comprising: a) a set of pulses applied at a first selected frequency of about 150-10,000 Hz, wherein each pulse of the set of pulses has a pulse width of at least 0.01 milliseconds and less than the period of the first selected frequency.

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 and have improved energy storage requirements.

Abstract: The present specification discloses devices and methodologies for the treatment of transient lower esophageal sphincter relaxations (tLESRs). Individuals with tLESRs 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: Apparatus and methods are provided, including a bladder stimulator that includes an elongate element adapted to pass through a urethra or adapted to pass through another opening in the bladder, an expandable body coupled to said elongate element, and an array of one or more stimulator contacts coupled to the expandable body, the array including at least one contact adapted to contact a portion of a bladder of a subject when the expandable body is inserted in the bladder and expanded. A controller stimulates the portion of the bladder by driving a pulse into the bladder via the contact, the pulse having a frequency of 5 Hz-1 kHz. Other applications 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: 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: Methods and devices create an intestinal braking effect, are non-invasive or minimally invasive, and may be reversible. These methods and devices are accomplished via stabilized implantable systems and ingestible pills. In one embodiment, a method of producing satiety comprising the steps of accessing a gastrointestinal tract of a patient and implanting an intraintestinal therapeutic substance eluting implant. The implant is capable of eluting a satiety inducing substance selected from at least one of a nutrient, a specific satiety inducing bio-active substance, pancreatic polypeptides, free fatty acids, cholecystokinin, amino acids, glutamine, lipids, linoleic acid, or a combination thereof, from the implant into the gastrointestinal tract.

Abstract: A method for regulating hormone production comprises placing at least one electrode in a gastrointestinal tract of a patient and recording an electrical signal during a preselected event produced by the gastrointestinal tract. The method further involves the steps of storing the electrical signal, and playing back the electrical signal by activating the electrode during the absence of the preselected event.

Abstract: At least one of a plurality of gastrointestinal disorders is treated by stimulating an enteric nervous system of a patient to enhance a functional tone of the enteric nervous system. A treatment includes electrically stimulating a vagus nerve of the patient at a stimulation site proximal to at least one site of vagal innervation of a gastrointestinal organ. The electrical stimulation includes applying a stimulation signal at the stimulation site. An optional proximal electrical blocking signal is applied to the vagus nerve at a proximal blocking site proximal to the stimulation site. The proximal blocking signal is selected to at least partially block nerve impulses at the proximal blocking site.

Abstract: Lumen-traveling biological interface devices and associated methods and systems are described. Lumen-traveling biological interface devices capable of traveling within a body lumen may include a propelling mechanism to produce movement of the lumen-traveling device within the lumen, electrodes or other electromagnetic transducers for detecting biological signals and electrodes, coils or other electromagnetic transducers for delivering electromagnetic stimuli to stimulus responsive tissues. Lumen-traveling biological interface devices may also include additional components such as sensors, an active portion, and/or control circuitry.

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: Disclosed is a method for lessening the effect of Benign Prostatic Hyperplasia by inducing increased urine flow and bladder emptying by a device including a plurality of protrusions configured to produce at least one stimulating effect on a predefined area of a foot.

Abstract: Methods for treating a patient and further to devices for performing such treatment, e.g., methods and devices to perturb at least one physiological system and deliver therapy to the patient based on the effects of such perturbation. For example, a method for using an implantable medical device is disclosed that involves a method for using an implantable medical device delivering electrical stimuli to an afferent nerve associated with the selected organ. The efferent electrical activity is monitored in an efferent nerve responsive to delivering electrical stimuli to the afferent nerve, the monitored efferent electrical activity includes an indirect component of a compound action potential (CAP). A status of the selected organ is assessed based upon the indirect component.

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 around 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 selected 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. The application of the electrical signal is discontinued. The application of the signal and the discontinuing of the signal are repeated with durations of the discontinuing and the application selected to treat the disorder.

Abstract: A treatment method is provided, including identifying a subject as one who is selected to undergo an interventional medical procedure, and, in response to the identifying, reducing a likelihood of a potential adverse effect of the procedure by applying an electrical current to a parasympathetic site of the subject selected from the group 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 coronary sinus of the subject, a vena cava vein of the subject, a jugular vein of the subject, a right ventricle of the subject, a parasympathetic ganglion of the subject, and a parasympathetic nerve of the subject.

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

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: 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: A system is provided for endoscopically attaching a functional device to a stomach wall wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach.

Abstract: A pancreatic controller, comprising: at least one electrode adapted for electrifying at least a portion of a pancreas; and a controller programmed to electrify said electrode so as to positively control at least the effect of at least two members of a group consisting of blood glucose level, blood insulin level and blood level of another pancreatic hormone. In one example, the controller controls insulin, glucagon and/or glucose blood levels.

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