MANAGING OBSTRUCTIVE SLEEP APNEA THROUGH UPPER AIRWAY DUAL NEUROSTIMULATION

20250090848

18/967162

December 03, 2024

At least some embodiments of the present disclosure are directed to systems and methods for managing sleep disordered breathing (e.g., obstructive sleep apnea) for a patient. A first implantable electrode delivers a first stimulation signal proximate to a first nerve of the patient to stimulate the first nerve and activate at least one first muscle for an upper airway dilation of the person. A second implantable electrode delivers a second stimulation signal proximate to a second nerve to stimulate the second nerve and activate at least one second muscle for a caudal tracheal traction for an upper airway of the person. A stimulation signal generator generates the first and second stimulation signals and coordinates the delivery of the first stimulation signal with the delivery of the second stimulation signal.

1. A system for managing obstructive sleep apnea for a person, the system comprising: a first implantable electrode configured to deliver a first stimulation signal proximate to a first nerve of the person to stimulate the first nerve and activate at least one first muscle for an upper airway dilation of the person; a second implantable electrode configured to deliver a second stimulation signal proximate to a second nerve to stimulate the second nerve and activate at least one second muscle for a caudal tracheal traction for an upper airway of the person; and a stimulation signal generator configured to deliver the first stimulation signal to the first implantable electrode, and deliver the second stimulation signal to the second implantable electrode, the first stimulation signal having a series of first stimulation cycles each including a first stimulation period and a first non-stimulation period, the second stimulation signal having a series of second stimulation cycles each including a second stimulation period and a second non-stimulation period, the delivery of the first stimulation signal being coordinated with the delivery of the second stimulation signal, wherein the second stimulation signal is configured to activate sternothyroid and sternohyoid simultaneously.

2. The system of claim 1, wherein the second implantable electrode is positioned at or proximate to a nerve segment connecting to a first branch and a second branch of an ansa cervicalis nerve to activate the sternothyroid and the sternohyoid simultaneously.

3. The system of claim 1, further comprising a controller functionally connected to the stimulation signal generator to control one or more stimulation parameters for the stimulation signal generator.

4. The system of claim 3, wherein the one or more stimulation parameters include one or more of an amplitude, a frequency, a pulse width, a rate of amplitude change, and a duty cycle.

5. The system of claim 3, wherein the controller is configured to control the operation of the stimulation signal generator in a first mode, wherein the stimulation signal generator is configured to synchronize the first stimulation periods and the first non-stimulation periods of the first stimulation signal with the second stimulation periods and the second non-stimulation periods of the second stimulation signal, respectively.

6. The system of claim 3, wherein the controller is configured to control the operation of the stimulation signal generator in a second mode, wherein a first duration of the first stimulation period is greater than a second duration of the second stimulation period.

7. The system of claim 6, wherein in the second mode, the first duration of the first stimulation period is two or more times greater than the second duration of the second stimulation period.

8. The system of claim 1, wherein the first implantable electrode is configured to deliver the first stimulation signal proximate to a hypoglossal nerve to stimulate the hypoglossal nerve and activate at least one tongue muscle.

9. The system of claim 1, wherein the second implantable electrode is configured to: deliver the second stimulation signal proximate to an ansa cervicalis nerve to stimulate the ansa cervicalis nerve; and activate a plurality of infrahyoid muscles within a strain range between a first strain value and a second strain value.

10. The system of claim 1, wherein the stimulation signal generator is configured to coordinate the delivery of the first stimulation signal and the delivery of the second stimulation signal based at least in part on a historical respiratory waveform.

11. The system of claim 1, wherein the stimulation signal generator comprises an internal timer to provide timing to coordinate the series of first stimulation cycles and the series of second stimulation cycles, independent of a respiratory status of the person.

12. The system of claim 1, further comprising one or more sensors to detect one or more physiological parameters including an apnea-hypopnea index (AHI), a posture change, a sleep stage, and a time of day.

13. The system of claim 12, further comprising a controller configured to control one or more stimulation parameters of the stimulation signal generator based at least in part on the one or more physiological parameters.

14. The system of claim 1, further comprising a third implantable electrode configured to deliver a third stimulation signal proximate to a third nerve to stimulate the third nerve.

15. A method for managing obstructive sleep apnea for a person, the method comprising: providing a first implantable electrode configured to deliver a first stimulation signal proximate to a first nerve to stimulate the first nerve and activate at least one first muscle for upper airway dilation; providing a second implantable electrode configured to deliver a second stimulation signal proximate to a second nerve to stimulate the second nerve and activate at least one second muscle for a caudal tracheal traction for an upper airway of the person; delivering the first stimulation signal to the first implantable electrode; and delivering the second stimulation signal to the second implantable electrode, wherein the first stimulation signal and the second stimulation signal are coordinated, and wherein the first stimulation signal has a series of first stimulation cycles each including a first stimulation period and a first non-stimulation period, the second stimulation signal has a series of second stimulation cycles each including a second stimulation period and a second non-stimulation period, and wherein the second stimulation signal is configured to activate sternothyroid and sternohyoid simultaneously.

16. The method of claim 15, wherein the second implantable electrode is positioned at or proximate to a nerve segment connecting to a first branch and a second branch of an ansa cervicalis nerve to activate the sternothyroid and the sternohyoid simultaneously.

17. The method of claim 15, further comprising: controlling one or more first stimulation parameters for the first stimulation signal; and controlling one or more second stimulation parameters for the second stimulation signal.

18. The method of claim 17, wherein the one or more first stimulation parameters and the one or more second stimulation parameters each include one or more of an amplitude, a frequency, a pulse width, a rate of amplitude change, and a duty cycle.

19. The method of claim 15, wherein the first implantable electrode is configured to deliver the first stimulation signal proximate to a hypoglossal nerve to stimulate the hypoglossal nerve and activate at least one tongue muscle.

20. The method of claim 19, wherein delivering the first stimulation signal further comprises delivering the first stimulation signal proximate to one or more medial branches of a hypoglossal nerve (m-XII) to stimulate the one or more medial branches and activate one or more protrusion muscles of the at least one tongue muscle including genioglossus.

21. The method of claim 15, wherein the second implantable electrode is configured to deliver a second stimulation signal proximate to an ansa cervicalis nerve to stimulate the ansa cervicalis nerve and activate a plurality of infrahyoid muscles within a strain range between a first strain value and a second strain value.

22. The method of claim 15, further comprising controlling operation of a stimulation signal generator in a first mode, wherein the stimulation signal generator is configured to synchronize the first stimulation periods and the first non-stimulation periods of the first stimulation signal with the second stimulation periods and the second non-stimulation periods of the second stimulation signal, respectively.

23. The method of claim 15, further comprising controlling operation of a stimulation signal generator in a second mode, wherein a first duration of the first stimulation period is two or more times greater than a second duration of the second stimulation period.

24. The method of claim 15, further comprising coordinating the delivery of the first stimulation signal and the delivery of the second stimulation signal based at least in part on a historical respiratory waveform of the person.

25. The method of claim 24, further comprising synchronizing the series of first stimulation cycles of the first stimulation signal with a current respiratory waveform of the person.

61

edspap.20250090848