Obstructive sleep apnea treatment devices, systems and methods

• US 8,626,304 B2
• Filed: 12/29/2010
• Issued: 01/07/2014
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Mazar, Scott T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US12/980,743
• Publication Number:
  US 20120010681A1
• Time in Patent Office: 1,105 Days
• Field of Search: 607/42, 607/48, 607/66, 607/118
• US Class Current: 607/48
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

In one embodiment, a method of treating an upper airway may include delivering a first electrical stimulation to a first portion of a nerve innervating a first upper airway muscle via a plurality of electrodes adjacent the nerve. The method may further include delivering a second electrical stimulation to a second portion of the nerve innervating a second upper airway muscle via the plurality of electrodes, wherein the second muscle is different from the first muscle.

Claims

1. A method of treating obstructive sleep apnea, the method comprising:

delivering a first electrical stimulation to a first portion of a nerve innervating a first upper airway muscle via a plurality of electrodes adjacent the nerve; and

delivering a second electrical stimulation to a second portion of the nerve innervating a second upper airway muscle via the plurality of electrodes, wherein the second muscle is different from the first muscle, wherein the first and second electrical stimulations are delivered repeatedly in an alternating pattern to treat obstructive sleep apnea, and wherein the first and second electrical stimulations are delivered only during an inspiratory phase of a respiratory cycle.

2. The method of claim 1, wherein the first electrical stimulation is delivered prior to and simultaneously with the second electrical stimulation.

3. The method of claim 1, wherein the first electrical stimulation is delivered for a first predetermined time period, the second electrical stimulation is delivered for a second predetermined time period, and the second predetermined time period is larger than the first predetermined time period.

4. The method of claim 1, wherein the first electrical stimulation differs from the second electrical stimulation in at least one of amplitude and frequency.

5. The method of claim 1, wherein the nerve is a hypoglossal nerve.

6. The method of claim 5, wherein a first electrode of the plurality of electrodes is positioned on the hypoglossal nerve at a location proximal of a portion innervating a genioglossus muscle and distal of a portion innervating a geniohyoid muscle.

7. The method of claim 5, wherein a first electrode of the plurality of electrodes is positioned on the hypoglossal nerve at a location proximal of a portion innervating a geniohyoid muscle and distal of portions innervating a hyoglossus muscle and a styloglossus muscle.

8. The method of claim 5, wherein a first electrode of the plurality of electrodes is positioned on the hypoglossal nerve at a location proximal of portions innervating a genioglossus muscle and a geniohyoid muscle, and distal of portions innervating a hyoglossus muscle and a styloglossus muscle.

9. The method of claim 5, wherein a first electrode of the plurality of electrodes is positioned on the hypoglossal nerve at a location proximal of portions innervating a genioglossus muscle, a hyoglossus muscle, and a styloglossus muscle.

10. The method of claim 1, wherein the plurality of electrodes includes at least three electrodes, and delivering a first electrical stimulation includes steering an electrical field to stimulate selected fascicles in the nerve.

11. A method of treating an upper airway of a patient, the method comprising:

positioning a plurality of electrodes adjacent a nerve innervating a plurality of upper airway muscles;

delivering a first electrical stimulation to a first portion of the nerve innervating a first muscle of the plurality of upper airway muscles;

delivering a second electrical stimulation to a second portion of the nerve innervating a second muscle of the plurality of upper airway muscles, wherein the second muscle is different from the first muscle; and

visually observing the upper airway of the patient during delivery of the first and second electrical stimulations with an imaging device, wherein the first and second electrical stimulations are delivered in a repeated, alternating pattern during an inspiratory phase of a respiratory cycle.

12. The method of claim 11, wherein the first electrical stimulation is delivered prior to and simultaneously with the second electrical stimulation.

13. The method of claim 11, wherein the first electrical stimulation is delivered for a first predetermined time period, the second electrical stimulation is delivered for a second predetermined time period, and the second predetermined time period is larger than the first predetermined time period.

14. The method of claim 11, wherein the first electrical stimulation differs from the second electrical stimulation in at least one of amplitude and frequency.

15. The method of claim 11, wherein observing the upper airway of the patient includes visually confirming an increase in a dimension of the upper airway.

16. A method of treating obstructive sleep apnea, the method comprising:

positioning a plurality of electrodes adjacent a nerve innervating a plurality of upper airway muscles, the nerve including a first set of fascicles innervating a first muscle of the plurality of upper airway muscles and a second set of fascicles innervating a second muscle of the plurality of upper airway muscles, wherein the first muscle is different from the second muscle;

selectively delivering a first electrical stimulation to the first set of fascicles; and

selectively delivering a second electrical stimulation to the second set of fascicles, wherein the first electrical stimulation and the second electrical stimulation are delivered repeatedly in an alternating pattern to treat obstructive sleep apnea, and wherein the first and second electrical stimulations are delivered only during an inspiratory phase of a respiratory cycle.

17. The method of claim 16, wherein the first muscle is a genioglossus muscle, and the second muscle is a geniohyoid muscle.

18. The method of claim 16, wherein the plurality of electrodes includes at least three electrodes, and delivering the first electrical stimulation includes steering an electrical field to stimulate selected fascicles of the nerve.

19. The method of claim 16, wherein the first electrical stimulation differs from the second electrical stimulation in at least one of amplitude and frequency.

20. The method of claim 16, wherein the method further comprises observing the upper airway of the patient during delivery of the first and second electrical stimulations with an imaging device.

21. A method of treating an upper airway of a patient, the method comprising:

positioning a plurality of electrodes adjacent a nerve innervating a plurality of upper airway muscles;

delivering a first electrical stimulation to a first portion of the nerve innervating a first muscle of the plurality of upper airway muscles;

delivering a second electrical stimulation to a second portion of the nerve innervating a second muscle of the plurality of upper airway muscles, wherein the second muscle is different from the first muscle; and

visualizing the upper airway of the patient during delivery of the first and second electrical stimulations with a visualization device, wherein the first and second electrical stimulations are delivered in a repeated, alternating pattern during an inspiratory phase of a respiratory cycle.

22. The method of claim 21, wherein the first and second electrical stimulations are delivered repeatedly in an alternating pattern.

23. The method of claim 21, wherein treating an upper airway of a patient includes preventing obstructive sleep apnea.

24. The method of claim 21, wherein the visualization device includes an optical scope.

25. The method of claim 24, wherein the optical scope includes a nasopharyngoscope.

26. The method of claim 21, wherein the plurality of electrodes are disposed in a nerve cuff.