Abstract: The present invention provides systems and methods for treating and/or controlling obesity and type II diabetes. In one aspect of the invention, a device for treating obesity includes a flow restrictor and an anchor coupled to the flow restrictor. The flow restrictor is movable between a first or collapsed configuration sized and shaped for endoscopic advancement through the patient's esophagus and into a distal region of the stomach and a second or operative configuration sized and shaped for inhibiting a flow of chyme from the stomach to the pyloric sphincter. It is believed that this will cause the prolongation of satiety, and result in fewer meals being eaten and/or smaller meals being ingested.

Abstract: Devices and systems are disclosed for the non-invasive treatment of medical conditions through delivery of energy to target tissue, comprising a source of electrical power, a magnetically permeable toroidal core, and a coil that is wound around the core. The coil and core are embedded in a continuous electrically conducting medium, which is adapted to have a shape that conforms to the contour of an arbitrarily oriented target body surface of a patient. The conducting medium is applied to that surface by any of several disclosed methods, and the source of power supplies a pulse of electric charge to the coil, such that the coil induces an electric current and/or an electric field within the patient, thereby stimulating tissue and/or one or more nerve fibers within the patient. The invention shapes an elongated electric field of effect that can be oriented parallel to a long nerve. In one embodiment, the device comprises two toroidal cores that lie adjacent to one another.

Abstract: Devices, systems, and methods for treating gastro-esophageal reflux disease (GERD) include anti-reflux valves and retainers for securing them within the lumen of the esophagus, stomach, or a hiatal hernia. The retainers contain inflatable balloons, some of which may be enveloped by a flexible shell that is used to secure the balloon to tissue. Methods are described for treating GERD patients who (1) have no hiatal hernia, (2) have a hiatal hernia that is fixed in place, or (3) have a hiatal hernia that slides above and below the diaphragm. Methods are also described for delivering GERD-treatment devices to their target locations within the patient's gastrointestinal tract.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a device comprises a hollow sleeve sized and shaped for positioning within a duodenum of the patient, an anchor coupled to the proximal end of the sleeve and being sized and shaped to inhibit distal migration of the sleeve and a plurality of elastomeric objects coupled to the distal end of the sleeve and being sized and shaped to inhibit proximal migration of the sleeve through a pylorus of the patient. The bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

Abstract: The present invention provides systems and methods for treating wounds in patients who lack the innate ability to regulate glucose (e.g., diabetic patients). In one aspect of the invention, a method includes positioning an internal bypass device within the duodenum to inhibit contact between chyme passing therethrough and an internal wall of the duodenum and maintaining the internal bypass device within the duodenum for a sufficient period of time to decrease insulin resistance and reduce a blood glucose level in the patient. The internal bypass device increases peripheral blood flow and elevates an immune system response to accelerate healing of the wound.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a bypass device includes gastric and duodenal anchors coupled to each other and positioned on either side of the pylorus and a hollow sleeve designed to extend from the pylorus through at least a proximal portion of a patient's small intestine. The gastric and duodenal anchors are movable between collapsed configurations for advancement through the esophagus and an expanded configuration for inhibiting movement of the anchors through the pyloric sphincter. Thus, the bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

Abstract: Devices, systems and methods are disclosed for treating bronchial constriction related to asthma, anaphylaxis, chronic obstructive pulmonary disease (COPD), exercise-induced bronchospasm and post-operative bronchospasm. The treatment comprises transmitting impulses of energy non-invasively to selected nerve fibers that activate neural pathways to reduce the release of acetycholine from airway-related vagal preganglionic neurons within the brain of the patient. The transmitted energy impulses, comprising magnetic and/or electrical energy, stimulate the selected nerve fibers to produce the bronchodilation.

Abstract: Devices, systems and methods are disclosed for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD, depression, anxiety, epilepsy, fibromyalgia, and the like. The invention involves the use of an energy source comprising magnetic and/or electrical energy that is transmitted non-invasively to, or in close proximity to, a selected nerve to temporarily stimulate, block and/or modulate the signals in the selected nerve such that neural pathways are activated to release inhibitory neurotransmitters in the patient's brain.

Abstract: Devices, systems and methods are disclosed for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD, depression, anxiety, epilepsy, fibromyalgia, and the like. The invention involves the use of an energy source comprising magnetic and/or electrical energy that is transmitted non-invasively to, or in close proximity to, a selected nerve to temporarily stimulate, block and/or modulate the signals in the selected nerve such that neural pathways are activated to release inhibitory neurotransmitters in the patient's brain.

Abstract: Devices, systems and methods are disclosed for treating a variety of diseases and disorders that are primarily or at least partially driven by an imbalance in neurotransmitters in the brain, such as asthma, COPD, depression, anxiety, epilepsy, fibromyalgia, and the like. The invention involves the use of an energy source comprising magnetic and/or electrical energy that is transmitted non-invasively to, or in close proximity to, a selected nerve to temporarily stimulate, block and/or modulate the signals in the selected nerve such that neural pathways are activated to release inhibitory neurotransmitters in the patient's brain.

Abstract: The present invention provides systems and methods for treating wounds in patients who lack the innate ability to regulate glucose (e.g., diabetic patients). In one aspect of the invention, a method includes positioning an internal bypass device within the duodenum to inhibit contact between chyme passing therethrough and an internal wall of the duodenum and maintaining the internal bypass device within the duodenum for a sufficient period of time to decrease insulin resistance and reduce a blood glucose level in the patient. The internal bypass device increases peripheral blood flow and elevates an immune system response to accelerate healing of the wound.

Abstract: Devices, systems and methods are disclosed for treating or preventing an autism spectrum disorder, a pervasive developmental disorder, or a disorder of psychological development. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve. The nerve stimulation may be used as a behavior conditioning tool, by producing euphoria in an autistic individual. Vagus nerve stimulation is also used to modulate circulating serotonin levels in a pregnant woman so as to reduce the risk of having an autistic child; modulate the levels of growth factors within a child; promote balance of neuronal excitation/inhibition; modulate the activity of abnormal resting state neuronal networks; increase respiratory sinus arrhythmia; and avert episodes of motor stereotypies with the aid of forecasting methods.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, a bypass device includes gastric and duodenal anchors coupled to each other and positioned on either side of the pylorus and a hollow sleeve designed to extend from the pylorus through at least a proximal portion of a patient's small intestine. The gastric and duodenal anchors are movable between collapsed configurations for advancement through the esophagus and an expanded configuration for inhibiting movement of the anchors through the pyloric sphincter. Thus, the bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

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: Energy is transmitted noninvasively to a patient using electrode-based stimulation devices or magnetic stimulation devices that are designed to non-invasively stimulate nerves selectively. The devices produce impulses that are used to treat atrial fibrillation, by stimulating a vagus nerve of a patient. The devices are also used to forecast the imminent onset of atrial fibrillation and then avert it by stimulating a vagus nerve.

Abstract: The present invention provides systems and methods for treating and controlling obesity and/or type II diabetes. In one aspect of the invention, an internal bypass device includes gastric and duodenal anchors coupled to each other and positioned on either side of the pylorus and a hollow sleeve designed to extend from the pylorus through at least a proximal portion of a patient's small intestine. The gastric and duodenal anchors are movable between collapsed configurations for advancement through the esophagus and an expanded configuration for inhibiting movement of the anchors through the pyloric sphincter. Thus, the bypass device can be placed and removed endoscopically through the patient's esophagus in a minimally invasive outpatient procedure and it is “self-anchoring” and does not require invasive tissue fixation within the patient's GI tract, thereby reducing collateral tissue damage and minimizing its impact on the digestive process.

Abstract: Transcutaneous electrical and magnetic nerve stimulation devices are disclosed, along with methods of averting imminent medical attacks using energy that is delivered noninvasively by the devices. The attacks comprise asthma attack, epileptic seizure, attacks of migraine headache, transient ischemic attack or stroke, onset of atrial fibrillation, myocardial infarction, onset of ventricular fibrillation or tachycardia, panic attack, and attacks of acute depression. The imminence of an attack is forecasted using grey-box or black-box models as used in control theory. In preferred embodiments of the disclosed methods, a vagus nerve in the neck of a patient is stimulated noninvasively to avert the attack.

Abstract: Devices, systems and methods are disclosed for treating or preventing dementia, such as Alzheimer's disease. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve, that modulate the activity of a patient's locus ceruleus. The transmitted energy impulses, comprising magnetic and/or electrical energy, stimulate the selected nerve fibers to cause the locus ceruleus to release norepinephrine into regions of the brain that contain beta-amyloids. The norepinephrine counteracts neuroinflammation that would damage neurons in those regions and the locus ceruleus, thereby arresting or slowing the progression of the disease in the patient.

Abstract: Transcutaneous electrical and magnetic nerve stimulation devices are disclosed, along with methods of averting imminent medical attacks using energy that is delivered noninvasively by the devices. The attacks comprise asthma attack, epileptic seizure, attacks of migraine headache, transient ischemic attack or stroke, onset of atrial fibrillation, myocardial infarction, onset of ventricular fibrillation or tachycardia, panic attack, and attacks of acute depression. The imminence of an attack is forecasted using grey-box or black-box models as used in control theory. In preferred embodiments of the disclosed methods, a vagus nerve in the neck of a patient is stimulated noninvasively to avert the attack.

Abstract: Transcutaneous electrical and magnetic nerve stimulation devices are disclosed, along with methods of averting imminent medical attacks using energy that is delivered noninvasively by the devices. In particular, the devices and methods involve handheld devices designed to stimulate the vagus nerve of a patient with a signal sufficient to minimize or avert epileptic seizures.