Cyberonics, Inc.

Joachim F Wernicke

Reese S Terry, Jr

Ross G Baker, Jr

Jacob Zabara

Paul Rutecki

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

Method and apparatus for treating and controlling sleep disorders by detecting the presence of the sleep disorder under treatment, and, in response, selectively applying a predetermined electrical signal to the patient's vagus nerve for stimulation thereof to alleviate the sleep disorder under treatment. The method and apparatus includes several techniques for detecting the presence of the sleep disorder under treatment, such as sensing the patient's EEG activity in the case of insomniac and hypersomniac patients, or detecting a sudden nodding of the head in the case of narcoleptic patients, or sensing the cessation of respiration in the case of sleep apnea patients.

Therapeutic treatment of sleep disorder by nerve stimulation

Method and apparatus for treating severe chronic, persistent or recurring neuropathic or psychogenic pain, or pain which is nociceptive if the patient is suffering from terminal disease, by selectively applying a pulse waveform to a lead/electrode implanted on the patient's cervical vagus nerve or other site preferably above the location of the pain to stimulate afferent fibers for activating a descending anti-nociceptive pathway and thereby blocking incoming pain signals. The pulse waveform has programmable pulse width, current level and frequency, and pulse sequence on and off time durations. The programmed pulse sequences are applied to the implanted electrode either on a continuous basis, or only during the period the patient is normally awake, or is initiated by the patient or automatically in response to the onset of pain. A method for use in advancing relief and control of pain includes providing the lead/electrode assembly to be implanted and the generator for the programmable pulse sequences, incorporating a connector on the generator to accommodate the lead, restricting the ranges of programmable values of the pulse sequences to values which in combination will stimulate the small afferent fibers of the vagus nerve to activate a descending anti-nociceptive pathway, and adapting the generator for physician selection of manner of control of commencement and cessation of the pulse sequences.

Treatment of pain by vagal afferent stimulation

Method and apparatus for treating and controlling neuropsychiatric disorders including schizophrenia, depression, and borderline personality disorder by selectively applying a predetermined electrical signal to the patient's vagus nerve for stimulation thereof to alleviate the symptoms of the disorder being treated. The electrical signal may be applied continuously, periodically, or intermittently to the vagus nerve depending, in part, on the nature of the disorder being treated. In certain instances, the electrical signal is applied upon detection of an event indicative of onset of the disorder. In other instances, the electrical signal is selectively applied at will to the vagus nerve, such as by patient activation of the signal generator. Parameter values of the electrical signal including pulse width, output current, frequency, on time and off time, are selectively programmable.

Treatment of neuropsychiatric disorders by nerve stimulation

A method of treating symptoms of dementia, including cortical dementia, subcortical dementia, and multi-infarct dementia, includes selecting a patient suffering from dementia, and applying to the patient's vagus nerve an electrical stimulation signal having parameter values selected to modulate the electrical activity of the vagus nerve in a manner to modulate the activity of preselected portions of the reticular activating system of the brain stem.

Treatment of dementia by nerve stimulation

A method of treating patients with compulsive eating disorders includes the steps of detecting a preselected event indicative of an imminent need for treatment of the specific eating disorder of interest, and responding to the detected occurrence of the preselected event by applying a predetermined stimulating signal to the patient's vagus nerve appropriate to alleviate the effect of the eating disorder of interest. For example, the preselected event may be a specified level of food consumption by the patient within a set interval of time, or the commencement of a customary mealtime according to the patient's circadian cycle, or the passage of each of a sequence of preset intervals of time, or the patient's own recognition of the need for treatment by voluntarily initiating the application of the stimulating signal to the vagus nerve. In cases in which the disorder is compulsive eating to excess, the stimulating signal is predetermined to produce a sensation of satiety in the patient. The occurrence of the preselected event is detected by summing the number of swallows of food by the patient within the set interval of time. In cases where the disorder is compulsive refusal to eat (anorexia nervosa), the stimulating signal is predetermined to produce a sensation of hunger or to suppress satiety in the patient.

Treatment of eating disorders by nerve stimulation

Method and apparatus are described for treating and controlling diabetes and other systemic pancreatic endocrine disorders attributable to abnormal levels of secretion of endogenous insulin. An electrical stimulator implanted into or worn external to the patient's body is adapted, when activated, to generate a programmable electrical waveform for application to electrodes implanted on the vagus nerve of the patient. The electrical waveform is programmed using parameter values selected to stimulate or inhibit the vagus nerve to modulate the electrical activity thereof to increase or decrease secretion of natural insulin by the patient's pancreas. The stimulator is selectively activated manually by the patient in response to direct measurement of blood glucose or symptoms, or is activated automatically by programming the activation to occur at predetermined times and for predetermined intervals during the circadian cycle of the patient. Alternatively, the automatic activation is achieved using an implanted sensor to detect the blood glucose concentration, and is triggered when the patient's blood glucose concentration exceeds or falls below a predetermined level depending on whether diabetes or hypoglycemia is being treated.

Treatment of endocrine disorders by nerve stimulation

Method and apparatus for treating and controlling migraine by selectively applying a predetermined electrical signal to the patient's vagus nerve for stimulation thereof to alleviate the migraine attack. The signal is a pulse waveform having parameters programmed to desynchronize the patient's EEG if paroxysmal activity is detected in the EEG, or to synchronize the EEG if low voltage fast wave activity is detected. Alternatively, the application of the stimulating signal to the vagus nerve may be initiated manually by the patient upon recognition of the onset of a migraine attack. The neurostimulator device implanted in the patient to generate the appropriate signal has a power down circuit to conserve battery power between migraine episodes.

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League City, TX, United States of America

Joachim F Wernicke