Obstructive sleep apnea treatment devices, systems and methods

• US 9,913,982 B2
• Filed: 05/12/2011
• Issued: 03/13/2018
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Kuhnley, Brian D., Suilmann, Dale G., Persson, Bruce J., Beck, John P., Hauschild, Sidney F., Tesfayesus, Wondimeneh, Skubitz, Jason J., Bosshard, Mark R., Parrish, Daniel A., Atkinson, Robert E.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): SO, ELIZABETH K
• Application Number:
  US13/106,460
• Publication Number:
  US 20120192874A1
• Time in Patent Office: 2,497 Days
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

Devices, systems and methods of neurostimulation for treating obstructive sleep apnea. The system is adapted to send an electrical signal from an implanted neurostimulator through a stimulation lead to a patient'"'"'s nerve at an appropriate phase of the respiratory cycle based on input from a respiration sensing lead. External components are adapted for wireless communication with the neurostimulator. The neurostimulator is adapted to deliver therapeutic stimulation based on inputs.

Claims

1. A method of delivering a nerve stimulation therapy to a subject via an implanted neurostimulator connected to a stimulation delivery lead, the method comprising:

delivering the nerve stimulation therapy at a first intensity during a first therapy period of the nerve stimulation therapy, wherein the first intensity is within a range having a lower bound and an upper bound, wherein the subject is awake during at least an initial portion of the first therapy period, and wherein the upper bound is a discomfort threshold; and

delivering the nerve stimulation therapy at a second intensity during a second therapy period of the nerve stimulation therapy subsequent to the first therapy period, wherein the second intensity is different from the first intensity, wherein the subject is asleep during at least an initial portion of the second therapy period,

wherein the nerve stimulation therapy is delivered to a nerve for treating a respiratory condition of the subject.

2. The method of claim 1, wherein the first therapy period is a programmed interval.

3. The method of claim 1, wherein a timing of an initiation of the second therapy period is selected before an initiation of the first therapy period.

4. The method of claim 1, wherein an initiation of the second therapy period is based on and/or responsive to at least one of a fixed duration of time, a number of breaths, a number of stimulations delivered during the first therapy period, an interval assigned to the first therapy period, and a detection of subject activity.

5. The method of claim 1, wherein the second intensity is greater than the first intensity.

6. The method of claim 5, wherein the second intensity is greater than the discomfort threshold.

7. The method of claim 1, wherein the second therapy period is consecutive to the first therapy period.

8. The method of claim 1, further comprising:

delivering the nerve stimulation therapy at an increasing level of intensity prior to the first therapy period, the increasing level of intensity maximizing at the first intensity.

9. The method of claim 1, wherein the first intensity is interposed with at least one of an additional intensity and a non-stimulating intensity of the first therapy period to define a therapy mode.

10. The method of claim 9, wherein each delivery of the first intensity is asynchronous with respiration.

11. The method of claim 9, wherein the therapy mode is at least one of an ABAB mode, an AOAO mode, an AABB mode, an xABO mode, an xAOB mode, and an xAB mode.

12. The method of claim 11, wherein each delivery of the first intensity is asynchronous with respiration.

13. The method of claim 1, wherein the second intensity is interposed with at least one of an additional intensity and a non-stimulating intensity of the second therapy period to define a therapy mode.

14. The method of claim 13, wherein each delivery of the second intensity is asynchronous with respiration.

15. The method of claim 13, wherein the therapy mode is at least one of an ABAB mode, an AOAO mode, an AABB mode, an xABO mode, an xAOB mode, and an xAB mode.

16. The method of claim 15, wherein each delivery of the second intensity is asynchronous with respiration.

17. The method of claim 1, wherein at least one of the first intensity and the second intensity is an amplitude of a current pulse.

18. The method of claim 1, wherein the discomfort threshold is defined while the subject is awake.

19. The method of claim 1, wherein the implanted neurostimulator includes at least one algorithm configured to provide:

a first capability to program the neurostimulator to deliver the first intensity during the first therapy period; and

a second capability to program the neurostimulator to deliver the second intensity during the second therapy period.

20. The method of claim 1, wherein the nerve is a hypoglossal nerve, and the respiratory condition is sleep apnea.

21. A method of delivering a nerve stimulation therapy to a subject via an implanted neurostimulator connected to a stimulation delivery lead, the method comprising:

delivering the nerve stimulation therapy at a first intensity during a first therapy period of the therapy, wherein the first intensity is within a range having a lower bound and an upper bound wherein the subject is awake during at least an initial portion of the first therapy period, and wherein the upper bound is a discomfort threshold;

transitioning from the first therapy period to a second therapy period of the nerve stimulation therapy subsequent to the first therapy period, the transitioning comprising a cessation of stimulation; and

delivering the nerve stimulation therapy at a second intensity during the second therapy period, wherein the second intensity is greater than the first intensity and the discomfort threshold wherein the subject is asleep during at least an initial portion of the second therapy period, wherein the nerve stimulation therapy is delivered to a nerve for treating a respiratory condition of the subject.

22. The method of claim 21, wherein the cessation of stimulation is due to subject action.

23. The method of claim 22, wherein the subject action is the initiation of a pre-set number of pauses.

24. The method of claim 21, wherein the second intensity is a product of a subject adjustment of the first intensity.

25. The method of claim 24, wherein the subject adjustment of the first intensity is limited to a pre-programmed range of second intensities.

26. The method of claim 21, further comprising:

delivering the nerve stimulation therapy at an increasing level of intensity between the cessation of stimulation and the second therapy period.

27. The method of claim 21, wherein the cessation of stimulation is prompted by a signal received from a sensor.

28. The method of claim 21, wherein at least one of the first intensity and the second intensity is an amplitude of a current pulse.

29. The method of claim 21, wherein the discomfort threshold is defined while the subject is awake.

30. The method of claim 21, wherein the implanted neurostimulator includes at least one algorithm configured to provide:

a first capability to program the neurostimulator to deliver the first intensity during the first therapy period; and

a second capability to program the neurostimulator to deliver the second intensity during the second therapy period.

31. A method of delivering a nerve stimulation therapy to a subject via an implanted neurostimulator connected to a stimulation delivery lead, the method comprising:

delivering the nerve stimulation therapy at a first intensity during a first therapy period of the nerve stimulation therapy, wherein the first intensity is within a range having a lower bound and an upper bound, wherein the subject is awake during at least an initial portion of the first therapy period, and wherein the upper bound is a threshold determined based on feedback from the subject; and

delivering the nerve stimulation therapy at a second intensity during a second therapy period of the nerve stimulation therapy subsequent to the first therapy period, wherein the second intensity is different from the first intensity, and wherein the subject is asleep during at least an initial portion of the second therapy period,

wherein the nerve stimulation therapy is delivered to a nerve for treating a respiratory condition of the subject.