Therapeutic treatment of sleep disorder by nerve stimulation

• US 5,335,657 A
• Filed: 05/03/1991
• Issued: 08/09/1994
• Est. Priority Date: 05/03/1991
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Terry, Reese S. Jr., Wernicke, Joachim F.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/695,558
• Time in Patent Office: 1,194 Days
• Field of Search: 128/419 S, 128/419 G, 128/419 R, 128/421, 128/422, 128/423 R, 600/28, 607/42, 607/44, 607/45, 607/72
• US Class Current: 607/45
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36078 Inducing or controlling sleep or relaxation non-implantable stimulator A61M21/00
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/3614 based on impedance measurement

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.

Claims

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, 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.

2. The method of claim 1, further including:

providing as the electrical stimulus a signal having programmable electrical parameters, and

programming the electrical parameters of the signal to modulate the electrical activity of the vagus nerve to control the EEG activity of the patient.

3. The method of claim 2, wherein:

and including;

programming at least some of the electrical parameters of the pulse waveform to synchronize or desynchronize the patient'"'"'s EEG activity according to the nature of the sleep disorder under treatment.

4. The method of claim 3, wherein

the detected event is one of (i) a desynchronous EEG pattern indicative of inability of the patient to sleep during nighttime hours, and (ii) a synchronous EEG pattern indicative of overwhelming desire of the patient to sleep during daytime hours;

and

the pulse waveform is programmed to synchronize the patient'"'"'s EEG activity upon detected event (i), and to desynchronize the patient'"'"'s EEG activity upon detected event (ii).

5. The method of claim 3, wherein:

the disorder under treatment is sleep apnea, and including;

detecting the physiological event by sensing a predetermined sustained period without respiration by the patient, and

programming the pulse waveform electrical parameters to modulate the electrical activity of the vagus nerve, upon application of the pulse waveform to the vagus nerve, to desynchronize the patient'"'"'s EEG upon sensing said predetermined sustained period without respiration.

6. The method of claim 3, including:

programming the electrical parameters of the pulse waveform including pulse width, output current or voltage, frequency, on time and off time.

7. The method of claim 3, wherein:

the disorder under treatment is insomnia, and including;

detecting the physiological event by sensing a respiration pattern of the patient indicative of wakefulness during normal nocturnal hours, and

programming the pulse waveform electrical parameters to modulate the electrical activity of the vagus nerve, upon application of the pulse waveform, to the vagus nerve, to synchronize the activity of the patient'"'"'s EEG upon sensing said respiration pattern indicative of wakefulness.

8. The method of claim 3, wherein the disorder under treatment is hypersomnia, and

the pulse waveform signal parameters are programmed to desynchronize the activity of the patient'"'"'s EEG.

9. The method of claim 1, wherein

the detected event includes one of (i) an EEG pattern of the patient reflecting presence of the sleep disorder under treatment, (ii) a sudden uncontrolled nodding of the patient'"'"'s head, and (iii) a cessation of respiration by the patient.

10. The method of claim 9, wherein

the predetermined signal has electrical parameters programmed to stimulate the vagus nerve to cause desynchronization of the patient'"'"'s EEG upon detected event (ii).

11. The method of claim 1, wherein

the event is detectable by the patient, and the electrical signal is manually activatable.

12. The method of claim 1, wherein

the step of detecting the event is performed by sensing abdominal impedance changes associated with respiration by the patient indicative of the sleep disorder under treatment, to signal the need for applying the predetermined electrical stimulus to the patient'"'"'s vagus nerve.

13. The method of claim 12, wherein

the step of sensing is performed to detect an abnormally along time interval in which the patient has stopped breathing.

14. The method of claim 12, wherein

the step of sensing is performed to detect respiration typically associated with a state of sleeplessness of the patient, during normal nocturnal hours.

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.

16. The method of claim 15, wherein

said electrical signal is a pulse waveform, and including:

selecting the patient'"'"'s vagus nerve as the cranial nerve to which the signal is to be applied, and

applying the programmed pulse waveform to a nerve electrode implanted on the patient'"'"'s vagus nerve.

17. The method of claim 16, including

programming the parameter values of the pulse waveform including pulse width, output current, frequency, on time and off time.

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.

19. A device for treating sleep disorders in human patients, comprising:

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.

20. The invention of claim 19, wherein:

said programming means includes means for limiting adjustment of the parameter values of the waveform to a range of values predetermined to be suitable for modulating the electrical activity of the vagus nerve to synchronize or desynchronize the activity of the patient'"'"'s EEG according to whether the sleep disorder under treatment is insomnia-related or hypersomnia-related, respectively.

21. The invention of claim 19, wherein:

said event is a physiological response of the patient indicative of the manifestation of the sleep disorder under treatment, and

said control means includes sensing means for detecting said physiological response to initiate the application of said waveform to said electrode means.

22. The invention of claim 21, wherein

said sensing means includes means for detecting the EEG activity of the patient.

23. The invention of claim 21, wherein

said sensing means includes means for detecting a sustained abnormal period of cessation of respiration of the patient.

24. The invention of claim 23, wherein

said means for detecting cessation of respiration includes means responsive to the absence of movement of the patient'"'"'s diaphragm for sensing said sustained abnormal period of cessation of respiration.

25. The invention of claim 23, wherein

said means for detecting cessation of respiration includes means responsive to the absence of nasal air flow by the patient.

26. The invention of claim 21, wherein

said sensing means includes means for detecting a sudden uncontrolled nodding of the patient'"'"'s head.

27. The invention of claim 21, wherein

said sensing means includes

an abdominal impedance detector, and

means responsive to predetermined changes in detected abdominal impedance to initiate the application of said waveform to said electrode means.

28. The invention of claim 19, wherein:

said event is a designated time during the circadian cycle of the patient when the patient should be sleeping, and

said control means includes timing means to energize said stimulus means and thereby cause the application of said waveform to said electrode means at said designated time for a predetermined time interval.

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:

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.

30. The method of claim 29, wherein the step of implementing the stimulus generator means includes arranging the stimulus generator means for selective variation of electrical parameters of the pulse sequences including pulse width, amplitude and frequency, sequence duration and intervals.

31. A method of treating patients suffering from a sleep disorder, which includes the steps of:

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.

32. The method of claim 31, wherein:

the output signal of the stimulus generator is a pulse waveform and the programmable parameters thereof include pulse width, output current or output voltage, frequency, on time and off time, and

the implanting of the nerve electrode is performed by securing the electrode to the vagus nerve at a site in the patient'"'"'s neck and electrically connecting the electrode via a conductive lead to the stimulus generator.

33. The method of claim 31, wherein:

the adapting of the stimulus generator to generate its output signal upon selective activation is performed by providing the stimulus generator with a sensor to detect an event associated with the sleep disorder under treatment and to activate the stimulus generator upon such detection, and including

implanting the sensor along with the stimulus generator.

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:

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.

35. The apparatus of claim 34, in which:

the neurostimulator device further includes manual activation means for alternative patient activation of the neurostimulator device to cause generation of the programmed electrical output signal thereof.

36. The apparatus of claim 34, in which the neurostimulator device includes:

means for generating the electrical output signal of the device in the form of a pulse waveform, and

selection means for programming signal parameters of the pulse waveform, including width of pulses, output current, output voltage, pulse frequency, and on time and off time of the waveform.