Obstructive sleep apnea treatment devices, systems and methods

• US 10,737,094 B2
• Filed: 10/18/2018
• Issued: 08/11/2020
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• 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.
• Primary Examiner(s): Abreu, Michael J D
• Application Number:
  US16/164,551
• Publication Number:
  US 20190151656A1
• Time in Patent Office: 663 Days
• 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 programmable neurostimulator comprising:

a processor configured to;

deliver a respiratory therapy to a subject;

titrate a stimulation setting of the respiratory therapy while the subject is awake by delivering a first set of stimulation pulses at a plurality of first stimulation setting values between a lower limit 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, repeat the step of titrating the stimulation setting of the respiratory therapy 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 subject is expected to at least partially arouse from sleep.

2. The programmable neurostimulator of claim 1, wherein the processor is configured to repeat the step of titrating the stimulation setting of the respiratory therapy by further 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. The programmable neurostimulator of claim 2, wherein the processor is configured to repeat the step of titrating the stimulation setting of the respiratory therapy by further comparing responses of the subject to the second and third sets of stimulation pulses.

4. The programmable neurostimulator of claim 3, wherein the processor is configured to compare the responses of the subject by comparing air flow of the subject responsive to the second and third sets of stimulation pulses.

5. The programmable neurostimulator of claim 4, wherein the processor is further configured to deliver controlled pressure to an airway of the subject while performing at least one of titrating or repeating the step of titrating the stimulation setting of the respiratory therapy.

6. The programmable neurostimulator of claim 5, wherein the controlled pressure creates a flow-limited state.

7. The programmable neurostimulator of claim 2, wherein the processor is configured to deliver the second and third sets of stimulation pulses in a sequence to define a stimulation pattern.

8. The programmable neurostimulator of claim 7, wherein the stimulation pattern comprises at least one of a period of no stimulation, an AB pattern, an ABAB pattern, an 0A0B pattern, or an AA pattern.

9. The programmable neurostimulator of claim 7, wherein the processor is configured to deliver the stimulation pattern in at least one of a manual mode, a synchronized mode, or a triggered mode.

10. The programmable neurostimulator of claim 2, wherein the third set of stimulation pulses comprises a different amplitude than the second set of stimulation pulses.

11. The programmable neurostimulator of claim 1, wherein the processor is configured to titrate the stimulation of the respiratory therapy such that the titrating defines a stimulation level operating window having a capture stimulation level and a maximum comfort stimulation level inclusively between which the programmable neurostimulator is configured to deliver the first set of stimulation pulses;

and

wherein the capture stimulation level corresponds to respiratory muscle movement and the maximum comfort stimulation level is greater than the capture stimulation level.

12. The programmable neurostimulator of claim 11, wherein the respiratory muscle movement is at least one of an initial response of the respiratory muscle to a stimulation, a tongue movement, or a tongue stiffening.

13. The programmable neurostimulator of claim 11, wherein the maximum comfort stimulation level corresponds to at least one of a sensation of pain or an inability to sleep.

14. The programmable neurostimulator of claim 11, wherein the processor is configured to deliver the second set of stimulation pulses at a magnitude that is greater than the maximum comfort stimulation level.

15. The programmable neurostimulator of claim 1, wherein the processor is configured to deliver the awake titration by performing at least one of:

determining a stimulation level operating window;

determining a stimulation level that causes muscle contraction;

or

determining a stimulation level that causes subject discomfort.

16. A programmable neurostimulator comprising:

a processor configured to;

deliver a respiratory therapy to a subject;

identify a stimulation operating window for the respiratory 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 an upper airway of the subject, 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; and

wherein the programmable neurostimulator is configured to identify the stimulation operating window for the respiratory therapy by;

titrating a stimulation setting of the respiratory therapy while the subject is awake by delivering successive stimulation bursts 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 respiratory therapy while the subject is asleep by delivering successive stimulation bursts until the asleep level of the second threshold is identified.

17. The programmable neurostimulator of claim 16, wherein the processor is further configured to deliver controlled pressure to an upper airway of the subject while performing at least one of titrating or repeating the step of titrating the stimulation setting.

18. The programmable neurostimulator of claim 17, wherein the controlled pressure creates a flow-limited state.

19. The programmable neurostimulator of claim 16, wherein the beneficial response comprises a muscle contraction.

20. The programmable neurostimulator of claim 16, wherein the unacceptable sensation comprises at least one of pain, arousal from sleep, or inability to sleep.