Obstructive sleep apnea treatment devices, systems and methods

• US RE48,024 E1
• Filed: 04/08/2015
• Issued: 06/02/2020
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Hauschild, Sidney F., Kaplan, Paula M., Kuhnley, Brian D., Jasperson, Keith E., Tesfayesus, Wondimeneh, Thorp, Christopher K.
• Primary Examiner(s): Williams, Catherine S
• Application Number:
  US14/681,764
• Time in Patent Office: 1,882 Days
• CPC Class Codes: N/A

Abstract

Devices, systems and methods for nerve stimulation for OSA therapy.

Claims

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

chronically implanting an electrode on a nerve innervating an upper airway dilator muscle;

sensing a measure of respiration;

analyzing the measure of respiration to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration;

predicting the onset of a future expiratory phase; and

beginning stimulation of the nerve a fraction of the calculated respiratory period before the onset of the future expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

2. The method of claim 1, wherein the fraction ranges between 30/100 and 50/100.

3. The method of claim 1, wherein the fraction is selectively adjustable.

4. The method of claim 1, wherein the measure of respiration is bio-impedance.

5. The method of claim 1, wherein the electrode is disposed on a nerve cuff operably connected to a first end of a stimulation lead.

6. The method of claim 5, wherein a second end of the stimulation lead is operably connected to a neurostimulator.

7. The method of claim 6, wherein the neurostimulator is operably connected to a respiration sensing lead having a proximal end and a distal portion, wherein the distal portion is connected to a respiration sensor.

8. The method of claim 6, wherein the neurostimulator includes electronics containing an algorithm.

9. The method of claim 8, wherein the algorithm triggers the delivery of the stimulation via the stimulation lead.

10. The method of claim 5, wherein the stimulation lead includes a sigmoid-shaped section.

11. The method of claim 5, wherein the nerve cuff is cylindrical and includes a first semi-cylindrical portion connected to a second semi-cylindrical portion.

12. The method of claim 11, wherein the first semi-cylindrical portion is shorter in length than the second semi-cylindrical portion.

13. The method of claim 5, wherein the nerve cuff is cylindrical and includes a semi-cylindrical portion having a plurality of extending semi-cylindrical arms having free ends.

14. The method of claim 5, wherein the nerve cuff includes a plurality of electrodes configured to steer an electrical field.

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

obtaining a respiration waveform;

analyzing the respiration waveform to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration;

predicting the onset of a future expiratory phase; and

stimulating a nerve to cause dilation of a patient'"'"'s upper airway, wherein stimulation of the nerve begins a fraction of the calculated respiratory period before the onset of the future expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

16. The method of claim 15, wherein the fraction is selectively adjustable.

17. The method of claim 15, wherein analyzing the respiration waveform to identify onsets of expiration includes identifying a peak of the respiration waveform.

18. A method of treating obstructive sleep apnea with an electrode implanted on a nerve innervating an upper airway dilator muscle, the method comprising:

sensing a measure of respiration to generate a respiration waveform;

analyzing the respiration waveform to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration identified in the respiration waveform; and

beginning stimulation of the nerve a fraction of the calculated respiratory period before an onset of a subsequent expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

19. The method of claim 18, wherein the fraction ranges between 30/100 and 50/100.

20. The method of claim 18, wherein the fraction is selectively adjustable.

21. The method of claim 18, wherein the fraction of the calculated respiratory period is a predetermined amount of time.

22. The method of claim 18, wherein the measure of respiration is bio-impedance.

23. The method of claim 18, wherein the electrode is disposed on a nerve cuff operably connected to a first end of a stimulation lead including a first sigmoid section.

24. The method of claim 23, wherein the stimulation lead includes an anchor device disposed between the first sigmoid section and a second sigmoid section.

25. The method of claim 23, wherein a second end of the stimulation lead is operably connected to a neurostimulator.

26. The method of claim 25, wherein the neurostimulator is operably connected to a respiration sensing lead having a proximal end and a distal portion, wherein the distal portion is connected to a respiration sensor.

27. The method of claim 23, wherein the nerve cuff is cylindrical and includes a first semi-cylindrical portion connected to a second semi-cylindrical portion.

28. The method of claim 27, wherein the first semi-cylindrical portion is shorter in length than the second semi-cylindrical portion.

29. The method of claim 23, wherein the nerve cuff is cylindrical and includes a semi-cylindrical portion having a plurality of semi-cylindrical arms extending therefrom, the plurality of semi-cylindrical arms having free ends.

30. The method of claim 23, wherein the nerve cuff includes a plurality of electrodes configured to steer an electrical field.

31. The method of claim 18, wherein the onsets of expiration are identified without identifying an onset of an inspiratory phase.

32. A method of treating obstructive sleep apnea the method comprising:

obtaining a respiration waveform;

analyzing the respiration waveform to identify onsets of expiration;

calculating a respiratory period from the identified onsets of expiration;

stimulating a nerve to cause dilation of a patient'"'"'s upper airway, wherein stimulation of the nerve begins a fraction of the calculated respiratory period before an onset of an expiratory phase; and

continuing stimulation of the nerve during an entire inspiratory phase, wherein the step of stimulating the nerve is performed without identifying an onset of the inspiratory phase, and

wherein the stimulation is delivered to the nerve via an electrode cuff positioned on the nerve and disposed on a distal end of a stimulation lead having a sigmoid section.

33. The method of claim 32, wherein analyzing the respiration waveform to identify onsets of expiration includes identifying a peak of the respiration waveform.

34. The method of claim 32, wherein the onsets of expiration are identified without identifying an onset of an inspiratory phase.

35. A method of treating obstructive sleep apnea using an electrode implanted on a nerve innervating an upper airway dilator muscle, the method comprising:

sensing a biological parameter to generate a respiration waveform;

analyzing the respiration waveform to identify at least a first onset of expiration and a second onset of expiration;

calculating a respiratory period from the identified first and second onsets of expiration; and

beginning stimulation of the nerve a fraction of the calculated respiratory period after the identified second onset of expiration, and continuing stimulation of the nerve during an entire inspiratory phase subsequent to the identified second onset of expiration, wherein the step of beginning stimulation is performed without identifying an onset of the subsequent inspiratory phase.

36. The method of claim 35, wherein the fraction ranges between 50/100 to 70/100.

37. The method of claim 35, wherein the electrode is disposed on a nerve cuff operably connected to a first end of a stimulation lead including a first sigmoid section.

38. The method of claim 37, wherein the stimulation lead includes an anchor disposed between the first sigmoid section and a second sigmoid section.

39. The method of claim 35, wherein the first and second onsets of expiration are identified without identifying an onset of an inspiratory phase.

40. A method of treating obstructive sleep apnea with an electrode implanted on a nerve innervating an upper airway dilator muscle, the method comprising:

sensing a measure of respiration;

analyzing the measure of respiration to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration; and

beginning stimulation of the nerve a fraction of the calculated respiratory period before an onset of an expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

41. The method of claim 40, wherein the electrode is disposed on a nerve cuff operably connected to a first end of a stimulation lead including a first sigmoid section.

42. The method of claim 41, wherein the stimulation lead includes an anchor disposed between the first sigmoid section and a second sigmoid section.

43. A method of treating obstructive sleep apnea using an electrode implanted on a nerve innervating an upper airway dilator muscle, the method comprising:

sensing a measure of respiration;

analyzing the measure of respiration to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration; and

beginning stimulation of the nerve a predetermined amount of time after the onset of an expiratory phase, and continuing stimulation of the nerve during an entire subsequent inspiratory phase, wherein the method is performed without identifying an onset of the subsequent inspiratory phase.

44. The method of claim 43, wherein the electrode is disposed on a nerve cuff operably connected to a first end of a stimulation lead including a first sigmoid section.

45. The method of claim 44, wherein the stimulation lead includes an anchor disposed between the first sigmoid section and a second sigmoid section.

46. A method of treating obstructive sleep apnea with an electrode implanted on a nerve innervating an upper airway dilator muscle, the method comprising:

sensing a measure of respiration;

analyzing the measure of respiration to identify onsets of expiration;

calculating a respiratory period from the identified onsets of expiration; and

beginning stimulation of the nerve a fraction of the calculated respiratory period before an onset of a subsequent expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase prior to the subsequent expiratory phase, wherein the step of beginning stimulation is performed without identifying an onset of the inspiratory phase.

47. The method of claim 46, wherein the fraction ranges between 30/100 and 50/100.

48. The method of claim 46, wherein the onsets of expiration are identified without identifying an onset of an inspiratory phase.

49. A method of treating obstructive sleep apnea with an electrode implanted on a nerve innervating an upper airway dilator muscle of a subject having a breathing pattern, the method comprising:

identifying onsets of expiration by analyzing portions of the breathing pattern;

calculating a respiratory period from the identified onsets of expiration; and

beginning stimulation of the nerve a fraction of the calculated respiratory period before an onset of a subsequent expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase prior to the subsequent expiratory phase, wherein the step of beginning stimulation is performed without identifying an onset of the inspiratory phase.

50. The method of claim 49, wherein the fraction ranges between 30/100 and 50/100.

51. The method of claim 49, wherein the onsets of expiration are identified without identifying an onset of an inspiratory phase.