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 for treating a gastrointestinal condition by transvascular neuromodulation of a target site of the autonomic nervous system and preferably a target site in communication with a sympathetic nerve chain. A method for treating a gastrointestinal condition via transvascular neuromodulation incorporating a closed-loop feedback system is also provided.

Abstract: Methods and devices for gastrointestinal stimulation are disclosed. In one embodiment, disclosed is an electrical stimulator device that includes a circuit board and a battery contained within a base housing; a conduction element; and at least one electrode. In some embodiments, the stimulator base housing can be directly attached to a wall of a body lumen. In other embodiments, the stimulator base housing can be attached to a cuff or a sleeve device. In still other embodiments, one or more elements of the system are free-floating within the GI tract. The devices can be delivered endoscopically, and in some embodiments toposcopically.

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: Described are pharmaceutical compositions comprising sibutramine, metformin, topiramate, and at least one pharmaceutically acceptable carrier or excipient. Another aspect of the present invention relates to a method of treating a patient suffering from obesity or needing to lose weight, comprising the step of co-administering to said patient a therapeutically effective amount of sibutramine, metformin, and topiramate. In certain embodiments, an aforementioned method is practiced in conjunction or tandem with a medical procedure or the use of a medical device or both.

Abstract: Methods and apparatus are provided for pulsed electric field neuromodulation via an intra-to-extravascular approach, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation and other conditions in target neural fibers. In some embodiments, the ITEV PEF system comprises an intravascular catheter having one or more electrodes configured for intra-to-extravascular placement across a wall of patient's vessel into proximity with target neural fibers. With the electrode(s) passing from an intravascular position to an extravascular position prior to delivery of the PEF, a magnitude of applied voltage or energy delivered via the electrode(s) and necessary to achieve desired neuromodulation may be reduced relative to an intravascular PEF system having one or more electrodes positioned solely intravascularly.

Abstract: Devices and methods of non-surgically providing vagus nerve therapy trans-esophageally to treat a variety of medical conditions are disclosed herein. In an embodiment, an implantable medical device comprises a support member having an outer surface. The support member is adapted to engage the inner wall of an esophagus. The IMD also comprises at least one electrode disposed on the outer surface of the support member. The at least one electrode is capable of applying a trans-esophageal electrical signal to the vagus nerve through the wall of the esophagus from the inner lumen thereof. The implantable medical device further comprises a signal generator coupled to the support member and to the at least one electrode. The signal generator causes the at least one electrode to apply an electrical signal to the vagus nerve to treat a medical condition.

Abstract: A method and device for electrically stimulating one or more structures in the gastrointestinal tract as described. 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. The method and device may be used to treat obesity and/or GERD.

Abstract: A method and apparatus for stimulating a portion of a vagus nerve of a patient to treat a gastrointestinal disorder is provided. At least one electrode is coupled to at least one portion of a vagus nerve of the patient. The portion of the a vagus nerve may include an esophageal plexus, a myenteric plexus of aurbach, a submucous plexus of the meissner, a principal nerve of the lesser curvature of the stomach, and a gastric branch of said vagus nerve. An electrical signal is applied to the portion of the vagus nerve using the electrode to treat the gastrointestinal disorder.

Abstract: A method of treating motility conditions, such as an arrest of intestinal peristalsis, includes introducing an electrode through the esophagus and into the digestive tract of the patient and applying an electrical impulse to the electrode to modulate one or more nerves within the digestive tract such that intestinal peristalsis function is at least partially improved.

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, system and method for electrically stimulating the stomach is provided. A device system and method for attaching a stimulating device to the stomach wall is also provided.

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: Systems and devices for selectively applying electrical energy to a target region beneath a skin surface of a patient involve applying an electrical impulse to one or more electrodes on a skin surface of the patient to modulate one or more nerves at the target region, where the impulse is substantially blocked at nerves located between the target region and the skin surface such that only the nerves at the target region are modulated by the electrical impulse.

Abstract: An apparatus for effecting the closure of a stoma, the apparatus comprising a stimulator arranged to provide a signal for stimulation of implanted contractile tissues positioned proximate to the stoma in order to facilitate closure of the stoma.

Abstract: Diet evaluation gastric apparatus (18) is provided, which detects when a patient (10) swallows, and detects the type and amount of matter ingested. The apparatus includes electrodes (74, 100) adapted to be coupled to the fundus and antrum of the patient and to measure electrical and mechanical activity therein, and a control unit (90) to analyze such electrical and mechanical activity and optionally apply electrical energy to modify the activity of tissue of the patient.

Abstract: A method and apparatus for treatment of an eating disorder includes electrically, mechanically and/or pharmaceutically/chemically stimulating a of the vagus nerve of the lower esophagus, cardia, esophageal/cardia junction, cardia/fundus junction or upper stomach so as to induce afferent action potentials on the vagus nerve. The device may be noninvasively adjusted after implantation to provide increased or decreased restriction on the patient's gastrointestinal tract. Each stimulus may be administered as a series of programmed pulses of defined amplitude, duration and period, to evoke a responsive signal to the brain by the target nerve, effective for producing a temporary feeling of satiety in the person. An implantable stimulus generator may be operatively coupled to a nerve electrode, pressure device or chemical outlet to apply a defined signal to a selected nerve branch.

Abstract: Apparatus is provided that includes a swallowable medical treatment device, which is configured to initially assume a contracted state having a volume of less than 4 cm3. The device includes a gastric anchor, which initially assumes a contracted size, and which is configured to, upon coming in contact with a liquid, expand sufficiently to prevent passage of the anchor through a round opening having a diameter of between 1 cm and 3 cm. The device also includes a duodenal unit, which is configured to pass through the opening, and which is coupled to the gastric anchor such that the duodenal unit is held between 1 cm and 20 cm from the gastric anchor. Other embodiments are also described.

Abstract: A fixation device for holding stimulating electrodes in electrical contact with the wall of a portion of the gastrointestinal tract is provided. In one embodiment, the fixation device includes an expandable member that fixes the electrodes in electrical contact with the gastrointestinal tract wall. Also provided is an implantable device and method for controlling the opening and/or closing of the pylorus. In particular a device and method is provided for stimulating the duodenum to control the closing/and or opening of the pylorus. Finally, a method is provided for treating obesity by controlling the pylorus to retain food in the stomach for a desired period of time, among other things to provide a feeling of-satiety and/or to reduce hunger. One aspect includes controlling the pylorus's contraction by electrical stimulation of the duodenum.

Abstract: The present invention relates to a device (2) for reducing weight in an individual, the device (2) comprising: a generator (42, 43) adapted to produce an electrical signal; at least a first set of electrodes (6) comprising two electrodes (10, 12) able to be connected to the generator (42, 43) and being intended to be fixed to a first vagus nerve (18) of the individual at a predefined distance one from another to apply the electrical signal to a portion (19) of the first vagus nerve (18) located between the electrodes (10, 12); characterized in that it comprises a short-circuiting switch (52) being adapted to short-circuit the electrodes (10, 12).

Abstract: A magnetic gastric reduction device includes magnetic elements adapted to couple to a stomach and a sensor adapted to detect stomach properties. The device also includes a control device operably coupled to the magnetic elements. The control device is adapted to operably communicate with the sensor and is configured to control the magnetic elements based on a property of the stomach detected by the sensor to cause the magnetic elements to selectively compress or decompress the stomach.

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. These artificially generated signals may be superimposed on existing, naturally present signals. 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: Methods are disclosed for applying an electrical stimulation signal to nerves and/or muscles to modulate (i.e., relax, relieve spasms or tighten) the smooth muscle of the sphincter of Oddi, which stimulation may be applied directly to the smooth muscle of the sphincter or by modulation of the signals applied to the sphincter through the heptactic plexus.

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

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: Neural Gastric Electrical Stimulation (NGES) is a new method for invoking gastric contractions under microprocessor control. However, optimization of this technique using feedback mechanisms to minimize power consumption and maximize effectiveness has been lacking. An apparatus and method are provided for inducing controlled gastro paresis. The apparatus comprises a contraction sensor, a stomach contraction generator, and a controller. The contraction sensor is responsive to circumferential contractions of the stomach, and outputs a signal indicative of a circumferential contraction. The stomach contraction generator induces a circumferential contraction upon receipt of an electrical signal from the controller. The controller sends the electrical signal to the generator upon receipt of the output signal from the sensor.

Abstract: An implantable gastrointestinal (GI) stimulation system includes an implantable medical device and at least one stimulus delivery device configured to be placed in one or more lymphatic vessels of a patient, such as the patient's thoracic duct and/or vessels branching from the thoracic duct. In one embodiment, the implantable medical device includes a GI stimulation circuit to deliver electrical stimulation pulses to one or more target regions adjacent to a lymphatic vessel through the stimulus delivery device. In one embodiment, to control obesity, the electrical stimulation pulses are delivered to the organs and/or nerves of the GI tract to create a sensation of satiety and/or to expedite food movement through the GI tract.

Abstract: Method and apparatus for treating obesity by an energy delivery device, such as a high focus ultrasound transducer, mounted for movement along two or three axes relative to the esophagus to deliver transesophageal energy to interrupt the function of vagal nerves. Preferably, movement along a longitudinal axis of the esophagus changes the site to which the energy is directed and movement transversely along a radius of the esophagus focuses the energy on a vagal nerve. The third degree of freedom relative to the esophagus is to rotate the transducer about the longitudinal axis of the esophagus.

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

Abstract: The invention is a method of treatment for reducing visceral pain by administering in an individual in need thereof gastrointestinal electrical stimulation in repetitive trains of short pulses, where the administration of gastrointestinal electrical stimulation reduces visceral pain in the individual. Also, provided is a method of treating gastrointestinal sensory dysfunction. Further, this invention provides methods for modulating sympathetic nervous system for the treatment of visceral pain by administering in an individual in need thereof repetitive trains of short pulse electrical stimulation of the sympathetic nerves, where the electrical stimulation provided is effective in reducing visceral pain.

Abstract: An apparatus, and method, for providing continence to a gastrointestinal ostomy of a patient, the apparatus having a sealing device for retaining discharge of intestinal effluents and waste products from the ostomy, at least one pair of electrodes capable of delivering electrical stimulation to affect the smooth muscles of the patient's intestine and a stimulation generator in electrical communication with at least one pair of electrodes and capable of generating said electrical stimulation, wherein the electrical stimulation is selected to induce muscle contraction, relaxation, a tonic state or a flaccid state in the smooth muscles of the patient's intestine.

Abstract: An apparatus, and method, for providing continence to a gastrointestinal ostomy of a patient, the apparatus having a sealing device for retaining discharge of effluents or waste products from an ostomy, at least one pair of electrodes capable of delivering electrical stimulation to affect the smooth muscles of the patient's intestine and a stimulation generator in electrical communication with at least one pair of electrodes and capable of generating said electrical stimulation, wherein the electrical stimulation is selected to induce muscle contraction, relaxation, a tonic state or a flaccid state in the smooth muscles of the patient's intestine.

Abstract: A device, system and method for electrically stimulating the stomach is provided. A device system and method for attaching a stimulating device to the stomach wall is also provided.

Abstract: The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue. More specifically, systems and methods are provided for introducing a flowable electrode to a target site within the patient such that the flowable electrode converts to a hardened electrode after being introduced to the target site. An electrical impulse is applied to the hardened electrode to modulate one or more nerve(s) at the target site. The electrode preferably comprises a conductive polymer material.

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

Abstract: Method for treating obesity in a mammal which has an oesophagus connected to a stomach at the level of an oesophagogastric junction region, the oesophagogastric junction region exhibiting a zigzag oesophagogastric mucosal junction line and a transverse mucosal fold raised by sling fibres, the mucosal fold being located downstream of the Z line, the mucosal fold and the Z line defining a conical structure delimiting an opening to the stomach, including creating a first stricture zone by reducing the cross section of the opening by introducing at least a first biocompatible substance implanted on or in the wall of the conical structure, at least at the level of the mucosal fold.

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

Abstract: A method and device for electrically stimulating one or more structures in the gastrointestinal tract as described. 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. The method and device may be used to treat obesity and/or GERD.

Abstract: A method of controlling obesity by physically narrowing the lumen of the pylorus One embodiment includes injection of a bio-compatible bulking or stiffening material into the pyloric sphincter area of the stomach. The injection of this material bulks the pyloric sphincter, narrowing the lumen, retarding stomach emptying and producing a feeling of satiation in the patient. The method may be practiced or supplemented by cauterization of the pyloric sphincter or by suturing the sphincter to narrow the same and may be augmented by inducing flacid paralysis of the stomach by injecting botulinum toxin into the muscle tissue of the antrum or fundus of the stomach.

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

Abstract: Apparatus (18) for treating a condition of a subject is provided. An electrode device (100) is adapted to be coupled to longitudinal nervous tissue (40) of the subject, and a control unit (50) is adapted to drive the electrode device to apply to the nervous tissue a current which is capable of inducing action potentials that propagate in the nervous tissue in a first direction, so as to treat the condition. The control unit is further adapted to suppress action potentials from propagating in the nervous tissue in a second direction opposite to the first direction.

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: A method to regulate the endocrine and exocrine glands generally comprising generating at least one glandular function waveform signal that substantially corresponds to at least one waveform signal that is generated in the body and is operative in the regulation of an endocrine or exocrine gland and transmitting the generated glandular function waveform signal to the subject's nervous system.

Abstract: A surgical method for gastrocnemius muscle reduction is provided. The method may search for a motor nerve associated with a gastrocnemius muscle of a patient, inserts a probe by penetrating an epidermis around the motor nerve and locates a tip of the probe in the motor nerve, stimulates the motor nerve through supply of an electric signal to the probe, thereby shutting down the motor nerve.

Abstract: A method and a multichannel implantable device are described for partial or complete restoration of impaired gastrointestinal motility, or for disturbing and/or partially or completely blocking normal gastrointestinal motility using one or multiple microsystem-controlled channels of circumferentially arranged sets of two or more electrodes which provide externally-invoked synchronized electrical signals to the smooth muscles via the neural pathways.

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. In another embodiment, the electrical signal is applied to the vagus nerve transmucosally. 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 pancreatitis. 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: 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: The present invention provides methods of treating a gastrointestinal condition. In some embodiments, the method generally includes administering a chemical or electrical stimulus to an artery of the gastrointestinal vasculature of the subject, a vein of the gastrointestinal vasculature of the subject, a nerve supplying an artery of the gastrointestinal vasculature of the subject, and/or a nerve supplying a vein of the gastrointestinal vasculature of the subject, wherein the chemical or electrical stimulus is effective for treating a gastrointestinal condition.