Obstructive sleep apnea treatment devices, systems and methods

• US 8,744,589 B2
• Filed: 12/29/2010
• Issued: 06/03/2014
• 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): ANTHONY, JESSICA LYNN
• Application Number:
  US12/980,807
• Publication Number:
  US 20110152966A1
• Time in Patent Office: 1,252 Days
• Field of Search: 607/42, 607/48, 607/66, 607/68, 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

A method of stimulating a nerve of a patient. The method may include positioning a first electrode set on a first portion of the nerve, wherein the first portion of the nerve innervates a first upper airway muscle of the patient. The method may include positioning a second electrode set on a second portion of the nerve, wherein the second portion of the nerve innervates a second upper airway muscle of the patient. The method may further include alternatively delivering an electrical stimulation to the first electrode set and to the second electrode set.

Claims

1. A method of stimulating a nerve of a patient, the method comprising:

positioning a first electrode set on a first portion of the nerve, wherein the first portion of the nerve innervates a first upper airway muscle of the patient;

positioning a second electrode set on a second portion of the nerve, wherein the second portion of the nerve innervates a second upper airway muscle of the patient; and

alternatively delivering an electrical stimulation to the first electrode set and to the second electrode set, wherein the first electrode set and the second electrode set share a common electrode.

2. The method of claim 1, wherein the first upper airway muscle is a genioglossus muscle, and the second upper airway muscle is a geniohyoid muscle.

3. The method of claim 1, wherein the first upper airway muscle is one of the left and right genioglossus muscles, and the second upper airway muscle is the other of the left and right genioglossus muscles.

4. The method of claim 1, wherein delivering electrical stimulation to the first electrode set includes steering an electrical field and stimulating selected fascicles of the nerve.

5. The method of claim 1, further comprising the step of observing an upper airway of the patient.

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

7. The method of claim 1, wherein alternatively delivering an electrical stimulation to the first and second electrode sets includes delivering the electrical stimulation at a duty cycle of approximately 50%.

8. The method of claim 1, wherein the first electrode set and the second electrode set are disposed in a single nerve cuff.

9. A method of stimulating a hypoglossal nerve of a patient, the method comprising:

alternating delivery of a first electrical stimulation to a first portion of the hypoglossal nerve that innervates a first upper airway muscle of the patient and a second electrical stimulation to a second portion of the hypoglossal nerve that innervates a second upper airway muscle of the patient, wherein the first electrical stimulation is delivered via a first electrode set, and the second electrical stimulation is delivered via a second electrode set, and wherein the first electrode set and the second electrode set share a common electrode.

10. The method of claim 9, wherein the first upper airway muscle is a geniohyoid muscle, and the second upper airway muscle is a genioglossus muscle.

11. The method of claim 9, wherein the first upper airway muscle is one of the left and right genioglossus muscles, and the second upper airway muscle is the other of the left and right genioglossus muscles.

12. The method of claim 9, further comprising repeating the alternating delivery of the first and second electrical stimulations.

13. The method of claim 9, wherein the first electrical stimulation differs from the second electrical stimulation by at least one of amplitude and frequency.

14. The method of claim 9, wherein the first and second electrode sets are positioned adjacent the hypoglossal nerve.

15. The method of claim 9, wherein delivering a first electrical stimulation to a first portion of the hypoglossal nerve includes steering an electrical field so as to stimulate only the first portion of the hypoglossal nerve.

16. The method of claim 9, wherein the first electrode set and the second electrode set are disposed in a single nerve cuff.

17. A method of activating an upper airway muscle of a patient, the method comprising:

positioning a plurality of electrodes proximate a nerve innervating the upper airway muscle, the nerve including a first set of fascicles innervating a first portion of the upper airway muscle and a second set of fascicles innervating a second portion of the upper airway muscle;

delivering a first electrical stimulation to only the first set of fascicles for a first predetermined amount of time, wherein the first electrical stimulation is delivered via a first set of the plurality of electrodes;

delivering a second electrical stimulation to only the second set of fascicles for a second predetermined amount of time, wherein the second electrical stimulation is delivered via a second set of the plurality of electrodes; and

repeatedly alternating delivery of the first electrical stimulation and the second electrical stimulation, wherein the first set of the plurality of electrodes and the second set of the plurality of electrodes share a common electrode.

18. The method of claim 17, wherein the plurality of electrodes are disposed in a cuff body having a first side with a first longitudinal edge and a second side with a second longitudinal edge, the cuff body having a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end, and wherein, when the plurality of electrodes are positioned proximate the nerve, the cuff body surrounds substantially an entire circumference of a portion of the nerve, the first and second longitudinal edges are unattached and facing one another, and the proximalmost and distalmost ends of the second longitudinal edge are disposed between the proximalmost and distalmost ends of the first longitudinal edge, wherein the distalmost end surface of the cuff body is not associated with the second side of the cuff body.

19. The method of claim 17, wherein the first predetermined amount of time is longer than the second predetermined amount of time.

20. The method of claim 17, wherein the first electrical stimulation differs from the second electrical stimulation by at least one of amplitude and frequency.

21. The method of claim 17, wherein the nerve is a hypoglossal nerve, and the upper airway muscle is capable of causing protrusion of a tongue of the patient.

22. The method of claim 17, wherein the first set of the plurality of electrodes and the second set of the plurality of electrodes are disposed in a single nerve cuff.

23. A method of activating an upper airway muscle of a patient, the method comprising:

positioning a plurality of electrodes proximate a nerve innervating the upper airway muscle, the nerve including a first set of fascicles innervating a first portion of the upper airway muscle and a second set of fascicles innervating a second portion of the upper airway muscle;

delivering a first electrical stimulation to only the first set of fascicles for a first predetermined amount of time;

delivering a second electrical stimulation to only the second set of fascicles for a second predetermined amount of time; and

repeatedly alternating delivery of the first electrical stimulation and the second electrical stimulation,

wherein the plurality of electrodes are disposed in a cuff body having a first side with a first longitudinal edge and a second side with a second longitudinal edge, the cuff body having a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end, and wherein, when the plurality of electrodes are positioned proximate the nerve, the cuff body surrounds substantially an entire circumference of a portion of the nerve, the first and second longitudinal edges are unattached and facing one another, and the proximalmost and distalmost ends of the second longitudinal edge are disposed between the proximalmost and distalmost ends of the first longitudinal edge, wherein the distalmost end surface of the cuff body is not associated with the second side of the cuff body.

24. The method of claim 23, wherein the first predetermined amount of time is longer than the second predetermined amount of time.

25. The method of claim 23, wherein the first electrical stimulation differs from the second electrical stimulation by at least one of amplitude and frequency.

26. The method of claim 23, wherein the nerve is a hypoglossal nerve, and the upper airway muscle is capable of causing protrusion of a tongue of the patient.

27. The method of claim 23, wherein the first electrical stimulation is delivered via a first electrode set and the second electrical stimulation is delivered via a second electrode set, wherein the first electrode set and the second electrode set are disposed in a single nerve cuff.

28. A method of stimulating a nerve of a patient, the method comprising:

positioning a first electrode set on a first portion of the nerve, wherein the first portion of the nerve innervates a first upper airway muscle of the patient;

positioning a second electrode set on a second portion of the nerve, wherein the second portion of the nerve innervates a second upper airway muscle of the patient; and

alternatively delivering an electrical stimulation to the first electrode set and to the second electrode set, wherein an electrode in the first electrode set is electrically common to an electrode in the second electrode set.

29. The method of claim 28, wherein the first upper airway muscle is a genioglossus muscle, and the second upper airway muscle is a geniohyoid muscle.

30. The method of claim 28, wherein the first upper airway muscle is one of the left and right genioglossus muscles, and the second upper airway muscle is the other of the left and right genioglossus muscles.

31. The method of claim 28, wherein delivering electrical stimulation to the first electrode set includes steering an electrical field and stimulating selected fascicles of the nerve.

32. The method of claim 28, further comprising the step of observing an upper airway of the patient.

33. The method of claim 28, wherein the nerve is a hypoglossal nerve.

34. The method of claim 28, wherein alternatively delivering an electrical stimulation to the first and second electrode sets includes delivering the electrical stimulation at a duty cycle of approximately 50%.

35. The method of claim 28, wherein the first electrode set and the second electrode set are disposed in a single nerve cuff.

36. A method of stimulating a hypoglossal nerve of a patient, the method comprising:

alternating delivery of a first electrical stimulation to a first portion of the hypoglossal nerve that innervates a first upper airway muscle of the patient and a second electrical stimulation to a second portion of the hypoglossal nerve that innervates a second upper airway muscle of the patient, wherein the first electrical stimulation is delivered via a first electrode set, and the second electrical stimulation is delivered via a second electrode set, and wherein an electrode in the first electrode set is electrically common to an electrode in the second electrode set.

37. The method of claim 36, wherein the first upper airway muscle is a geniohyoid muscle, and the second upper airway muscle is a genioglossus muscle.

38. The method of claim 36, wherein the first upper airway muscle is one of the left and right genioglossus muscles, and the second upper airway muscle is the other of the left and right genioglossus muscles.

39. The method of claim 36, further comprising repeating the alternating delivery of the first and second electrical stimulations.

40. The method of claim 36, wherein the first electrical stimulation differs from the second electrical stimulation by at least one of amplitude and frequency.

41. The method of claim 36, wherein the first and second electrode sets are positioned adjacent the hypoglossal nerve.

42. The method of claim 36, wherein delivering a first electrical stimulation to a first portion of the hypoglossal nerve includes steering an electrical field so as to stimulate only the first portion of the hypoglossal nerve.

43. The method of claim 36, wherein the first electrode set and the second electrode set are disposed in a single nerve cuff.

44. A method of activating an upper airway muscle of a patient, the method comprising:

positioning a plurality of electrodes proximate a nerve innervating the upper airway muscle, the nerve including a first set of fascicles innerving a first portion of the upper airway muscle and a second set of fascicles innervating a second portion of the upper airway muscle;

delivering a first electrical stimulation to only the first set of fascicles for a first predetermined amount of time, wherein the first electrical stimulation is delivered via a first set of the plurality of electrodes;

delivering a second electrical stimulation to only the second set of fascicles for a second predetermined amount of time, wherein the second electrical stimulation is delivered via a second set of the plurality of electrodes; and

repeatedly alternating delivery of the first electrical stimulation and the second electrical stimulation, wherein an electrode in the first set of the plurality of electrodes is electrically common to an electrode in the second set of the plurality of electrodes.

45. The method of claim 44, wherein the plurality of electrodes are disposed in a cuff body having a first side with a first longitudinal edge and a second side with a second longitudinal edge, the cuff body having a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end, and wherein, when the plurality of electrodes are positioned proximate the nerve, the cuff body surrounds substantially an entire circumference of a portion of the nerve, the first and second longitudinal edges are unattached and facing one another, and the proximalmost and distalmost ends of the second longitudinal edge are disposed between the proximalmost and distalmost ends of the first longitudinal edge, wherein the distalmost end surface of the cuff body is not associated with the second side of the cuff body.

46. The method of claim 44, wherein the first predetermined amount of time is longer than the second predetermined amount of time.

47. The method of claim 44, wherein the first electrical stimulation differs from the second electrical stimulation by at least one of amplitude and frequency.

48. The method of claim 44, wherein the nerve is a hypoglossal nerve, and the upper airway muscle is capable of causing protrusion of a tongue of the patient.

49. The method of claim 44, wherein the first set of the plurality of electrodes and the second set of the plurality of electrodes are disposed in a single nerve cuff.