Obstructive sleep apnea treatment devices, systems and methods

• US 10,632,306 B2
• Filed: 08/25/2017
• Issued: 04/28/2020
• 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, Kaplan, Paula M., Hoyhtya, Adam K., Tesfayesus, Wondimeneh, Atkinson, Robert E., Eastwood, Peter R., Hillman, David R.
• Primary Examiner(s): D Abreu, Michael J
• Application Number:
  US15/687,271
• Publication Number:
  US 20180008824A1
• Time in Patent Office: 977 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. An implantable neurostimulation system for delivering a respiratory therapy to a subject, comprising:

a neurostimulator adapted to deliver a neurostimulation signal to the subject, the neurostimulator comprising a microprocessor programmed to;

titrate 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 limit defined by a capture threshold corresponding to a beneficial effect of the respiratory therapy and a first upper limit defined by a comfort threshold corresponding to a negative sensation experienced by the subject; and

subsequently, when the subject is asleep, repeat 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. The neurostimulation system of claim 1, wherein the awake titration includes determining a stimulation level that causes the subject discomfort.

3. The neurostimulation system of claim 2, wherein the microprocessor is further programmed to, as part of the asleep titration, compare the subject'"'"'s responses to the second and third sets of stimulation pulses.

4. The neurostimulation system of claim 2, wherein the third set of stimulation pulses has a different amplitude than the second set of stimulation pulses.

5. The neurostimulation system of claim 2, wherein the second and third sets of stimulation pulses are delivered in a sequence to define a stimulation pattern.

6. The neurostimulation system of claim 2, wherein the awake titration includes determining a stimulation level operating window.

7. The neurostimulation system of claim 1, wherein the microprocessor is programmed to perform at least one of the awake titration or the asleep titration in response to an input from a user.

8. The neurostimulation system of claim 7, wherein the input defines at least one of the lower limit, the first upper limit, or the second upper limit.

9. The neurostimulation system of claim 1, wherein the awake titration includes determining a stimulation level operating window.

10. The neurostimulation system of claim 1, wherein the awake titration includes determining a stimulation level that causes muscle contraction.

11. The neurostimulation system of claim 1, wherein the microprocessor is further programmed to, as part of the asleep titration, subsequently deliver 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.

12. The neurostimulation system of claim 1, wherein the awake titration defines a stimulation level operating window having a capture stimulation level and a maximum comfort stimulation level inclusively between which the first set of stimulation pulses is delivered, the capture stimulation level corresponding to respiratory muscle movement, the maximum comfort stimulation level being greater than the capture stimulation level.

13. The neurostimulation system of claim 1, wherein the second set of stimulation pulses are delivered at a magnitude that is greater than the maximum comfort stimulation level.