Obstructive sleep apnea treatment devices, systems and methods

• US 9,744,354 B2
• Filed: 12/30/2009
• Issued: 08/29/2017
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• 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., Kaplan, Paula M., Hoyhtya, Adam K., Tesfayesus, Wondimeneh, Atkinson, Robert E., Eastwood, Peter R., Hillman, David R.
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US12/650,045
• Publication Number:
  US 20100174341A1
• Time in Patent Office: 2,799 Days
• Field of Search: 607 42, 607 48
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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 1/36139 with automatic adjustment

Abstract

Devices, systems and methods of neurostimulation for treating obstructive sleep apnea.

Claims

1. A method of delivering a respiratory therapy to a subject via a programmable neurostimulator communicating with a stimulation delivery lead implanted in the subject, the method comprising:

titrating a stimulation setting of the neurostimulator while the subject is awake by delivering a first set of stimulation pulses at a plurality of first stimulation setting values between a lower limited defined by a capture threshold corresponding to a beneficial effect of the respiratory therapy and an upper limit defined by a comfort threshold corresponding to an unacceptable sensation experienced by the subject; and

subsequently, while the subject is asleep, repeating the step of titrating the stimulation setting of the neurostimulator by delivering a second set of stimulation pulses at a plurality of second stimulation setting values, wherein one or more of the plurality of second stimulation setting values is different than one or more of the plurality of first stimulation setting values and the plurality of second stimulation setting values are between the lower limit defined by the capture threshold and a second upper limit defined by a threshold at which the patient is expected to at least partially arouse from sleep.

2. A method as in claim 1, wherein repeating the step of titrating the stimulation setting of the neurostimulator includes subsequently delivering a third set of stimulation pulses at a plurality of third stimulation setting values, wherein one or more of the plurality of third stimulation setting values is different than one or more of the plurality of second stimulation setting values.

3. A method as in claim 2, wherein repeating the step of titrating the stimulation setting of the neurostimulator further includes comparing the subject'"'"'s responses to the second and third stimulation signals.

4. A method as in claim 3, wherein comparing the responses includes comparing air flow.

5. A method as in claim 4, further comprising:

delivering controlled pressure to an airway of the subject while titrating and/or repeating the step of titrating the stimulation setting of the neurostimulator.

6. A method as in claim 5, wherein the controlled pressure creates a flow-limited state.

7. A method as in claim 2, wherein the second and third sets of stimulation pulses are delivered in a sequence to define a stimulation pattern.

8. A method as in claim 7, wherein the stimulation pattern includes a period of no stimulation.

9. A method as in claim 7, wherein the stimulation pattern includes at least one of an AB pattern, an ABAB pattern, an 0A0B pattern, or an AA pattern.

10. A method as in claim 7, wherein the stimulation pattern is delivered in a manual mode.

11. A method as in claim 7, wherein the stimulation pattern is delivered in a synchronized mode.

12. A method as in claim 7, wherein the stimulation pattern is delivered in a triggered mode.

13. A method as in claim 2, wherein the third set of stimulation pulses has a different amplitude than the second set of stimulation pulses.

14. A method as in claim 2, wherein titrating the stimulation setting of the neurostimulator while the subject is awake includes determining a stimulation level operating window.

15. A method as in claim 1, wherein the titrating defines a stimulation level operating window having a capture stimulation level and a maximum comfort stimulation level inclusively between which the first stimulation signal is delivered, the capture stimulation level corresponding to respiratory muscle movement, the maximum comfort stimulation level being greater than the capture stimulation level.

16. The method of claim 15, wherein the respiratory muscle movement is an initial response of the respiratory muscle to a stimulation.

17. The method of claim 15, wherein the respiratory muscle movement is a tongue movement or stiffening.

18. The method of claim 15, wherein the maximum comfort stimulation level corresponds to at least one of a sensation of pain or an inability to sleep.

19. The method of claim 15, wherein the second stimulation signal is delivered at a magnitude that is greater than the maximum comfort stimulation level.

20. A method as in claim 1, wherein the awake titration includes determining a stimulation level operating window.

21. A method as in claim 1, wherein the awake titration includes determining a stimulation level that causes muscle contraction.

22. A method as in claim 1, wherein the awake titration includes determining a stimulation level that causes subject discomfort.

23. A method of delivering a therapy to an upper airway of a subject via a neurostimulator and a stimulation delivery lead implanted in the subject, with an electrode coupled to the stimulation lead disposed adjacent to a nerve stimulating an upper airway muscle of the subject, the method comprising:

identifying a stimulation operating window for the therapy, wherein the stimulation operating window includes a first threshold and a second threshold, wherein the first threshold is defined as a first level of stimulation at which a beneficial response is observed in the upper airway, and wherein the second threshold is defined as a second level of stimulation greater than the first level of stimulation, wherein the second threshold comprises an awake level at which the subject experiences an unacceptable sensation while awake and an asleep level greater than the awake level at which the subject is expected to at least partially arouse from sleep, wherein identifying the stimulation operating window for the therapy comprises;

titrating a stimulation setting of the neurostimulator while the subject is awake, wherein the titrating includes delivering successive stimulation bursts, via the electrode, until the first threshold and the awake level of the second threshold are identified, wherein at least one of the successive stimulation bursts includes an intensity different than another one of the successive stimulation bursts; and

subsequently repeating the step of titrating the stimulation setting of the neurostimulator while the subject is asleep, wherein the repeating the step of titrating includes delivering successive stimulation bursts, via the electrode, until the asleep level of the second threshold is identified.

24. The method of claim 23, further comprising:

delivering controlled pressure to the upper airway of the subject while titrating and/or repeating the step of titrating said stimulation setting.

25. The method of claim 24, wherein the controlled pressure creates a flow-limited state.

26. The method of claim 23, wherein the beneficial response includes muscle contraction.

27. The method of claim 23, wherein the unacceptable sensation includes at least one of pain, arousal from sleep, and inability to sleep.

28. The method of claim 23, wherein at least one of the first level of stimulation or the second level of stimulation is delivered in a synchronized mode.