Therapeutic treatment of sleep disorder by nerve stimulation
First Claim
1. A method of treating patients experiencing sleep disorders, which includes the steps of:
- detecting a physiological event associated with the sleep disorder in the patient to be treated, andupon detection of such physiological event, applying a predetermined electrical stimulus to the patient'"'"'s vagus nerve for modulating the electrical activity of the vagus nerve to alleviate the sleep disorder under treatment.
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0 Petitions
Accused Products
Abstract
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.
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Citations
36 Claims
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1. A method of treating patients experiencing sleep disorders, which includes the steps of:
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detecting a physiological event associated with the sleep disorder in the patient to be treated, and upon detection of such physiological event, applying a predetermined electrical stimulus to the patient'"'"'s vagus nerve for modulating the electrical activity of the vagus nerve to alleviate the sleep disorder under treatment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of treating patients with sleep disorder, which includes
generating an electrical signal having a predetermined set of parameters, programming the electrical signal by adjusting said parameters to predetermined values according to the sleep disorder under treatment, detecting the presence of the sleep disorder under treatment, and, in response to such detection, applying the programmed electrical signal to a selected cranial nerve of the patient to modulate the electrical activity of the selected cranial nerve to alleviate the sleep disorder under treatment.
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18. In a method of treating patients with sleep disorders, the step of applying an electrical signal with parameters programmed to alleviate the sleep disorder under treatment to the vagus nerve of the patient to modulate the electrical activity thereof at predetermined times and for predetermined time intervals during the patient'"'"'s circadian cycle.
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19. A device for treating sleep disorders in human patients, comprising:
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stimulus means responsive to being energized for generating an electrical waveform having adjustable parameter values, electrode means structurally adapted to be implanted on a patient'"'"'s cranial nerve which, when the electrical activity of the nerve is modulated by an applied electrical signal, evokes a predictable response in the EEG activity of the patient according to the parameter values of the applied electrical signal, the electrode means further structurally adapted to be electrically connectable to the stimulus means for delivering the electrical waveform generated by the stimulus means to said cranial nerve of the patient to modulate its electrical activity, programming means operatively associated with said stimulus means for controllably adjusting the parameter values of the electrical waveform generated by said stimulus means, and control means responsive to the occurrence of an event associated with the sleep disorder to be treated for energizing the stimulus means to generate said electrical waveform for application to the electrode means when connected to the stimulus means, so that the adjusted parameter values of the electrical waveform are delivered to said cranial nerve on which the electrode means are implanted and modulate its electrical activity to controllably vary the patient'"'"'s EEG activity and alleviate the sleep disorder under treatment. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method for use in advancing the treatment and control in patients of sleep disorders detectable by an implanted or external sensor, which comprises:
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fabricating electrode means including an electrical lead with a stimulating electrode assembly at its distal end for implantation on a preselected cranial nerve of a patient which is responsive to electrical stimulation to selectively synchronize or desynchronize the patient'"'"'s EEG, implementing programmable stimulus generator means for generating, in response to detection by said sensor of the sleep disorder under treatment, electrical pulse sequences with selectively variable electrical parameters for selective application to the electrode means when implanted on said preselected cranial nerve, incorporating electrical connector means in the stimulus generator means for electrically connecting the proximal end of the electrical lead to the stimulus generator means to receive the electrical pulse sequences generated by the stimulus generator means, restricting the programmable ranges of values of the electrical pulse sequences to values which in combination will stimulate the small afferent fibers of the preselected cranial nerve when one or more programmed pulse sequences are applied to the nerve via the electrode means, for the purpose of selectively synchronizing or desynchronizing the patient'"'"'s EEG activity according to the nature of the sleep disorder to be treated upon said detection of the disorder, adapting the stimulus generator means for physician control of the programming, and implanting the stimulus generator means and the electrode means into a patient suffering from a sleep disorder, for use in the treatment and control of the sleep disorder. - View Dependent Claims (30)
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31. A method of treating patients suffering from a sleep disorder, which includes the steps of:
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providing an electrical stimulus generator with an electrical output signal having parameters which are programmable within respective ranges predetermined, when the programmed output signal is properly applied to the vagus nerve of the patient, to relive a sleep disorder of a patient under treatment, and adapting the stimulus generator to generate its output signal upon selective activation of the stimulus generator, implanting the stimulus generator in the patient'"'"'s body, and implanting a nerve electrode to receive the output signal of the stimulus generator on the vagus nerve of the patient, and programming at least some of the programmable parameters of the output signal of the stimulus generator according to the nature of the sleep disorder suffered by the particular patient under treatment to modulate the electrical activity of the vagus nerve, upon activation of the stimulus generator and consequent application of the programmed output signal thereof to the vagus nerve through the nerve electrode implanted thereon, to alleviate the sleep disorder suffered by the patient. - View Dependent Claims (32, 33)
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34. Apparatus for therapeutically treating patients suffering from a sleep disorder such as insomnia or hypersomnia, in which the apparatus includes an implantable programmable neurostimulator device adapted to generate a programmed electrical output signal upon activation of the device, and an implantable electrical lead assembly connectable at its proximal end to the neurostimulator device to receive the programmed output signal thereof and having an electrode at its distal end adapted to be secured to a selected cranial nerve of the patient being treated, for electrical excitation of the selected cranial nerve to controllably modulate its electrical activity, characterized in that the apparatus further includes:
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sensor means electrically coupled to the neurostimulator device for detecting the occurrence of a predetermined event associated with the sleep disorder of interest, and activator means responsive to detection of such occurrence for activating the neurostimulator device to apply its programmed electrical output signal to the electrical lead assembly, and in which the neurostimulator device includes means for rendering the output signal parameters thereof programmable only within respective ranges preselected to modulate the electrical activity of the selected cranial nerve so as to synchronize or desynchronize the patient'"'"'s EEG according to whether the patient being treated is suffering from insomnia or hypersomnia, respectively. - View Dependent Claims (35, 36)
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Specification