Cyberonics, Inc.

Southern Illinois University

Other

Reese S Terry, Jr

Joachim F Wernicke

Ross G Baker, Jr

Burke T Barrett

Jacob Zabara

Douglas C Smith

Ronald A Browning

Dean K Naritoku

Robert A Jensen

Kevin B Clark

Robert A Adkins

Alan Adkins

Andre Marquette

Paul Rutecki

Cormac A O'Donovan

A method of treating a patient with at least one substance addiction, which comprises directly stimulating a cranial nerve, such as the vagus nerve, of a patient with an electrical pulse signal defined by a plurality of parameters to provide a therapy regimen for alleviating a symptom associated with the substance addiction.

Cranial nerve stimulation for treatment of substance addiction

A method of providing an electrical signal to a cranial nerve of a patient for treating a medical condition, including providing an electrical signal generator, coupling at least a first electrode to a cranial nerve of the patient and to the electrical signal generator, generating an electrical signal with the electrical signal generator, and applying the electrical signal to the cranial nerve, using the at least a first electrode, for a duration less than a cardiac period of the patient and during the cardiac period of the patient. In addition, an implantable medical device capable of implementing the method is disclosed.

Neurostimulation with signal duration determined by a cardiac cycle

We disclose a method of providing an electrical signal to a cranial nerve of a patient for treating a medical condition, comprising providing an electrical signal generator, coupling at least a first electrode to a cranial nerve of the patient and to the electrical signal generator, generating an electrical signal with the electrical signal generator, and applying the electrical signal to the cranial nerve, using the at least a first electrode, for a duration less than a cardiac period of the patient and during the cardiac period of the patient. We also disclose an implantable medical device capable of implementing the method.

A device for treating patients suffering from congestive heart failure includes an implantable neurostimulator for stimulating the patient's vagus nerve at or above the cardiac branch with an electrical pulse waveform at a stimulating rate sufficient to maintain the patient's heart beat at a rate well below the patient's normal resting heart rate, thereby allowing rest and recovery of the heart muscle, to increase in coronary blood flow, and/or growth of coronary capillaries. A metabolic need sensor detects the patient's current physical state and concomitantly supplies a control signal to the neurostimulator to vary the stimulating rate. If the detection indicates a state of rest, the neurostimulator rate reduces the patient's heart rate below the patient's normal resting rate. If the detection indicates physical exertion, the neurostimulator rate increases the patient's heart rate above the normal resting rate.

Treatment of congestive heart failure and autonomic cardiovascular drive disorders

A method for treating patients with movement disorders includes unilaterally or bilaterally stimulating one or both of the left and right branches of a patient's vagus nerve directly or indirectly with an electrical pulse signal generated by an implantable neurostimulator with at least one operatively coupled nerve electrode to apply the pulse signal to the selected nerve branch at a location in the vicinity of the patient's diaphragm, either slightly above or slightly below the diaphragm. A device for performing the method includes a government approved implantable neurostimulator which is programmable to enable physician programming of electrical and timing parameters of the pulse signal, to generate the desired therapy regimen for alleviating the disorder by application of the therapeutic electrical stimulation signal to a selected nerve. Automatic detection or patient sensing of a symptom of the disorder may be utilized for activating the device.

Treatment of movement disorders by near-diaphragmatic nerve stimulation

A method and apparatus for treating patients with neuropsychiatric disorder includes unilaterally or bilaterally stimulating one or both of the left and right branches of a patient's vagus nerve directly or indirectly with an electrical pulse signal generated by an implantable neurostimulator with at least one operatively coupled nerve electrode to apply the pulse signal to the selected nerve branch at a location in the vicinity of the patient's diaphragm, either slightly above or slightly below the diaphragm. The implantable neurostimulator is programmable to enable physician programming of electrical and timing parameters of the pulse signal, to generate the desired therapy regimen for alleviating the disorder. Patient activation of the device is permitted in the case of treating a neuropsychiatric disorder such as depression, where the patient is able to sense a symptom of a disorder.

Treatment of neuropsychiatric disorders by near-diaphragmatic nerve stimulation

Methods of improving memory and learning in humans and animals by vagus nerve stimulation are provided. These methods comprise selecting an appropriate human or animal subject and applying to the subject's vagus nerve an electrical stimulation signal having parameter values effective in modulating the electrical activity of the vagus nerve in a manner so as to modulate the activity of preselected portions of the brain.

Methods for improving learning or memory by vagus nerve stimulation

A method is disclosed for treating patients suffering from heart failure to increase cardiac output. The patient's vagus nerve is electrically stimulated or modulated with a sequence of substantially equally spaced pulses by an implanted neurostimulator, and the frequency of the stimulating pulses is adjusted until the patient's heart rate reaches a target rate within a relatively stable target rate range below the low end of the patient's customary resting heart rate. The frequency of the stimulating pulses is maintained at the frequency which ultimately produced the relatively stable target rate range so as not to deviate markedly from the target rate, at least so long as the patient remains at rest. An activity sensor associated with the implanted neurostimulator detects physical activity of the patient and adjusts the frequency of the stimulating pulses accordingly, to elevate the heart rate during periods of physical activity by the patient. When the patient ceases the activity, the vagal stimulation reverts along a prescribed fall-back path to a frequency that will reproduce the target heart rate.

Method to enhance cardiac capillary growth in heart failure patients

Methods of modulating brain neural plasticity, improving memory and learning, improving recovery from traumatic brain injury, preventing epilepsy, treating memory disorders and chronic memory impairment, and treating persistent impairment of consciousness in humans and animals by vagus nerve stimulation are provided. These methods comprise selecting an appropriate human or animal subject and applying to the subject's vagus nerve an electrical stimulation signal having parameter values effective in modulating the electrical activity of the vagus nerve in a manner so as to modulate the activity of preselected portions of the brain.

Methods of modulating aspects of brain neural plasticity by vagus nerve stimulation

Methods of treating traumatic brain injury by vagus nerve stimulation

A device and method of controlling seizures in an epileptic patient, in which the device is implanted in the patient for selective activation to generate an electrical waveform constituting a pre-programmed therapy regimen for application to the patient's vagus nerve to modulate the electrical activity thereof in a manner to inhibit, abort, or reduce the severity and duration of the seizure. The device is activated to generate the waveform upon detecting a time rate of change in the patient's heart rate relative to a predetermined threshold time rate of change which is sufficiently abrupt and of sufficient magnitude to be inconsistent with normal physical activity, as being indicative of an imminent epileptic seizure. Sustained cardiac activity at the highest heart rate detected in the change in heart rate is used as a confirmation of imminent seizure. The electrical waveform is generated a burst of pulses, with a minimum time interval between consecutive pulse bursts selected to avoid overstimulation of the nerve. Cardiac activity of the patient is detected using electrodes which include the conductive housing for the device and a stimulating electrode to be mounted on the nerve for large signal detection, or which are integral with the device housing itself so that no electrical leads are required to be implanted for such detection and the electrodes are arranged to detect the cardiac activity with a sensitivity that is substantially independent of orientation of the device as implanted in the patient.

Automatic activation of a neurostimulator device using a detection

A method of treating patients suffering from refractory hypertension includes identifying a patient suffering from the disorder and applying a stimulating electrical signal to the patient's vagus nerve predetermined to modulate the electrical activity of the nerve and to alleviate the hypertension. The step of applying the stimulation may be performed manually by the patient, or automatically following detection of the hypertension by sensing the patient's blood pressure, or, preferably by continuous or periodic application without use of a sensor. The stimulating signal is a pulse waveform with programmable signal parameter values including pulse width, output current, frequency, on time and off time.

Treating refractory hypertension by nerve stimulation

A method of treating a patient in coma is performed by placing an electrode in juxtaposition with a preselected cranial nerve of the patient for electrical stimulation of the nerve, applying an electrical pulse waveform to the electrode to stimulate the cranial nerve, and adjusting electrical parameters of the pulse waveform to modulate electrical activity of the nerve in an effort to rouse the patient from the coma. The patient's response to the treatment is monitored and assessed by the attending physician according to Glasgow coma scale. The preferred cranial nerve is the vagus nerve, and the stimulation is performed either for acute treatment by positioning an esophageal electrode in the patient for stimulating a region of the vagus nerve in the neck, or for longer term treatment by implanting a nerve electrode on the vagus nerve. The electrical parameters of the pulse waveform to be adjusted, by programming, include pulse frequency, pulse width, pulse current, pulse voltage, waveform on time, and waveform off time. The programming is performed to control the patient's EEG activity by said modulation of the electrical activity of the vagus nerve. Preferably, the EEG activity is desynchronized.

Treatment of patients in coma by nerve stimulation

Apparatus for treating patients with motility disorders applies a modulating signal to the patient's vagus nerve to stimulate or inhibit neural impulses and produce excitatory or inhibitory neurotransmitter release by the vagus nerve according to the specific nature of the motility disorder. The apparatus includes a neurostimulator which can be activated to generate an electrical output signal. The neurostimulator is responsive to the sensing of a selected event having occurred which is indicative of the need for treatment of the motility disorder, and includes an activation element which responds to sensing of that event to activate the neurostimulator, and a lead with an electrode array to apply the electrical output signal as the modulating signal to the patient's vagus nerve. Certain parameters of the output signal are programmable, and the neurostimulator can be calibrated according to the specific patient and the specific motility disorder being treated. One form of sensor detects the impedance of a selected part of the gastrointestinal system to detect the presence of excessive contractions in that part as an indication of hypermotility whether or not food has been consumed by the patient within a preset interval of time, and inadequate contractions in that part as an indication of hypomotility if food was consumed by the patient within a preset interval of time.

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Houston, TX, United States of America

Reese S Terry, Jr