Method of treating obstructive sleep apnea using electrical nerve stimulation

• US 20060224211A1
• Filed: 04/19/2005
• Published: 10/05/2006
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Yoo, Paul Byongsuk, Durand, Dominique M.
• Granted Patent: US 7,680,538 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A method for treating a medical condition, such as obstructive sleep apnea, includes the step of stimulating a nerve, particularly the hypoglossal nerve, using at least one of the following techniques: (a) continuous low-level electrical stimulation; (b) electrical stimulation synchronized with a physical process, such as inspiration, without feedback from the nerve being stimulated; and (c) intermittent electrical stimulation at controlled intervals based on the patient'"'"'s metabolism.

Claims

1. A method for controlling the patency of a patient'"'"'s airway, comprising the step of electrically stimulating a nerve to activate a muscle, including the step of intermittently stimulating the nerve at predetermined intervals based on a patient'"'"'s metabolism.

2. A method as set forth in claim 1, wherein the stimulating step includes stimulating the hypoglossal nerve to activate at least the genioglossus muscle.

3. A method as set forth in claim 1, wherein the stimulating step includes stimulating the hypoglossal nerve to activate at least one of the genioglossus muscle, the hyoglossus muscle or the styloglossus muscle.

4. A method as set forth in claim 1, wherein the stimulating step includes selectively stimulating at least one fascicle of the hypoglossal nerve to activate a muscle.

5. The method as set forth in claim 4, wherein the stimulating step includes selectively electrically stimulating hypoglossal nerve fascicles that activate functionally opposite muscles, including the genioglossus and styloglossus muscles.

6. The method as set forth in claim 4, wherein the stimulating step includes selectively electrically stimulating hypoglossal nerve fascicles that activate functionally similar muscles.

7. The method as set forth in claim 6, wherein the stimulating step includes selectively electrically stimulating hypoglossal nerve fascicles that activate the genioglossus and geniohyoid muscles.

8. A method as set forth in claim 1, wherein the stimulating step includes selectively stimulating at least one fascicle of the lingual nerve to initiate a reflex response in the hypoglossal nerve to activate a muscle.

9. A method as set forth in claim 1, wherein the stimulating step includes applying an electrical stimulus through an electrode intimately connected around the nerve.

10. A method as set forth in claim 1, wherein the stimulating step includes stimulating the nerve with an electrical pulse train having an amplitude of about 200 microamps to about 500 milliamps.

11. A method as set forth in claim 1, wherein the stimulating step includes stimulating the nerve with an electrical pulse train having a frequency of about 10 Hertz to about 30 Hertz.

12. A method as set forth in claim 1, wherein the stimulating step includes applying a train of stimulus pulses for about 2 seconds to about 3 seconds and then stopping application of the train for about 2 seconds to about 3 seconds.

13. A method as set forth in claim 1, wherein the stimulating step includes stimulating the nerve with an electrical pulse train at about 20 Hertz for about 2.5 seconds, and waiting at least 2 seconds before stimulating the nerve again.

14. A method as set forth in claim 1, used to treat obstructive sleep apnea (OSA) in a human patient, including the step of implanting an electrode in intimate contact around a nerve.

15. A method as set forth in claim 14, wherein the stimulating step includes stimulating the nerve with a with a train of stimulus pulses having a predetermined amplitude of at least the patient'"'"'s activation threshold.

16. A method as set forth in claim 1, further comprising the steps of determining a patient'"'"'s basal metabolic rate and the patient'"'"'s threshold activation amplitude, and setting the intervals for stimulating the nerve and the amplitude of the pulse train.

21. A method as set forth in claim 1, wherein the stimulating step includes synchronizing the electrical stimulus with inspiration by detecting either chest expansion or air pressure in the airway.

22. A method as set forth in claim 1, wherein the stimulating step includes stimulating the entire nerve upon expiration.

17. A method for treating sleep apnea, comprising the step of continuously electrically stimulating at least one fascicle of the hypoglossal nerve at a predetermined amplitude of about 10% less than the threshold amplitude necessary to activate a muscle of a patient up to approximately the patient'"'"'s threshold activation amplitude.

18. A method for controlling the patency of a patient'"'"'s airway, comprising the steps of electrically stimulating a nerve, and initiating the stimulating step in response to a physical process other than a signal from the nerve being stimulated.

19. A method as set forth in claim 18, wherein the stimulating step includes synchronizing the initiating step with a patient'"'"'s respiration cycle.

20. The method as set forth in claim 19, wherein the stimulating step includes synchronizing the electrical stimulation with inspiration of the patient.