US-12623078-B2 - System and method for treating obstructive sleep apnea

Abstract

One aspect of the present disclosure relates to a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

Inventors

• Francis A. Papay
• Anthony V. Caparso

Assignees

• THE CLEVELAND CLINIC FOUNDATION
• XII MEDICAL, INC.

Dates

Publication Date

20260512

Application Date

20230906

Claims (20)

1. 1 . A method for treating disordered breathing that occurs during sleep in a subject comprising: positioning a neurostimulator in a head of the subject, the neurostimulator comprising a stimulating electrode and an electromyogram (EMG) sensor, wherein the neurostimulator is positioned such that the stimulating electrode and the EMG sensor are both in electrical communication with a muscle that controls a tongue of the subject and/or both in electrical communication with a nerve that controls the muscle of the tongue; for a given respiratory cycle that includes an inspiration phase and an expiration phase, the expiration phase occurring subsequent to the inspiration phase and the inspiration phase following an expiration phase of a respiratory cycle preceding the given respiratory cycle: after the expiration phase of the respiratory cycle immediately preceding the given respiratory cycle but prior to the onset of the inspiration phase of the given respiratory cycle, sensing EMG activity of the muscle of the tongue with the implanted EMG sensor and detecting an EMG signal indicative of an upcoming onset of the inspiration phase of the given respiratory cycle; and activating the neurostimulator to provide an electrical signal to the muscle of the tongue or nerve at the onset of or during the inspiration phase of the given respiratory cycle in response to the EMG signal to decrease the subject's airway resistance and treat the disordered breathing.
2. 2 . The method of claim 1 , wherein the electrical stimulation ends at an onset of the expiration phase of the given respiratory cycle.
3. 3 . The method of claim 1 , wherein the EMG signal indicative of the onset of the inspiration phase is sensed prior to the onset of the inspiration phase of the given respiratory cycle but after an expiration phase of a respiratory cycle preceding the given respiratory cycle.
4. 4 . The method of claim 1 , further comprising monitoring the sensed EMG activity for another EMG signal indicative of an onset of the expiration phase of the given respiratory cycle.
5. 5 . The method of claim 1 , wherein the electrical stimulation ends at an end of the inspiration phase of the given respiratory cycle.
6. 6 . The method of claim 1 , wherein the stimulating electrode and the EMG sensor are both in electrical communication with a genioglossus muscle of the tongue of the subject or both in electrical communication with a nerve that controls the genioglossus muscle.
7. 7 . The method of claim 1 , wherein the stimulating electrode is carried by a first lead and the neurostimulator further comprises a second lead.
8. 8 . The method of claim 1 , wherein the neurostimulator comprises two or more electrodes and positioning the neurostimulator comprises placing the two or more electrodes bilaterally into electrical communication with the tongue.
9. 9 . The method of claim 1 , wherein providing the electrical signal to the nerve comprises electrically stimulating the hypoglossal nerve and/or its distal arborizing branches at or near its neuromuscular junction.
10. 10 . The method of claim 1 , wherein the stimulating electrode is carried by a lead, and the lead of the neurostimulator is in direct electrical communication with a power source.
11. 11 . The method of claim 1 , wherein the stimulating electrode is carried by a lead, and the lead of the neurostimulator includes an anchoring element.
12. 12 . The method of claim 1 , wherein the neurostimulator comprises at least two leads, each of the leads having at least two electrodes and positioning the neurostimulator comprises positioning the at least two leads at different spatial locations.
13. 13 . The method of claim 1 , wherein the EMG signal indicative of the onset of the inspiration phase of the given respiratory cycle comprises an increase in EMG activity compared to a baseline level of the EMG activity, the increase in EMG activity occurring prior to the onset of the inspiration phase of the given respiratory cycle.
14. 14 . A method for treating disordered breathing that occurs during sleep in a subject, the subject having a first respiratory cycle and a second respiratory cycle subsequent to the first respiratory cycle and each of the first and second respiratory cycles having an inspiration phase followed by an expiration phase, the method comprising: positioning a neurostimulator in a head of the subject, the neurostimulator comprising a stimulating electrode and an electromyogram (EMG) sensor, wherein the neurostimulator is positioned such that the stimulating electrode and the EMG sensor are both in electrical communication with a muscle that controls a tongue of the subject and/or both in electrical communication with a nerve that controls the muscle of the tongue; after the expiration phase of the first respiratory cycle but prior to the onset of the inspiration phase of the second respiratory cycle, sensing EMG activity of the muscle of the tongue with the implanted EMG sensor and detecting an EMG signal indicative of an upcoming onset of the inspiration phase of the second respiratory cycle, wherein the EMG signal comprises an increase in EMG activity compared to a baseline level of the EMG activity, the increase in EMG activity occurring prior to the onset of the inspiration phase of the second respiratory cycle; and activating the neurostimulator to provide an electrical signal to the muscle of the tongue or nerve at or just prior to the onset of the inspiration phase of the second respiratory cycle in response to the EMG signal to decrease the subject's airway resistance and treat the disordered breathing.
15. 15 . The method of claim 14 , wherein the electrical stimulation ends at an onset of the expiration phase of the second respiratory cycle.
16. 16 . The method of claim 14 , wherein the EMG signal indicative of the onset of the inspiration phase is sensed prior to the onset of the inspiration phase of the second respiratory cycle but after the expiration phase of the first respiratory cycle.
17. 17 . The method of claim 14 , further comprising monitoring the sensed EMG activity for another EMG signal indicative of an onset of the expiration phase of the second respiratory cycle.
18. 18 . The method of claim 14 , wherein the electrical stimulation ends at an end of the inspiration phase of the second respiratory cycle.
19. 19 . The method of claim 14 , wherein the stimulating electrode and the EMG sensor are both in electrical communication with a genioglossus muscle of the tongue of the subject or both in electrical communication with a nerve that controls the genioglossus muscle.
20. 20 . The method of claim 14 , wherein the stimulating electrode is carried by a first lead and the neurostimulator further comprises a second lead.

Description

RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 16/507,390 filed on Jul. 10, 2019, now U.S. Pat. No. 11,771,899, which claims priority to U.S. Provisional Application No. 62/696,135 filed on Jul. 10, 2018, the entirety of each of which is incorporated by reference herein. TECHNICAL FIELD The present disclosure relates generally to a system and method for treating sleep disorders and, more particularly, to a system and method for treating obstructive sleep apnea. BACKGROUND Obstructive sleep apnea (OSA) is highly prevalent, affecting one in five adults in the United States. One in fifteen adults has moderate to severe OSA requiring treatment. Untreated OSA results in reduced quality of life measures and increased risk of disease including hypertension, stroke, heart disease, etc. Continuous positive airway pressure (CPAP) is a standard treatment for OSA. While CPAP is non-invasive and highly effective, it is not well tolerated by patients or sleeping partners. Patient compliance for CPAP is often reported to be between 40% and 60%. Surgical treatment options for OSA, such as anterior tongue muscle repositioning, orthognathic bimaxillary advancement, uvula-palatal-pharyngoplasty, and tracheostomy are available too. However, they tend to be highly invasive (result in structural changes), are irreversible, and have poor and/or inconsistent efficacy. Even the more effective surgical procedures are undesirable because they usually require multiple invasive and irreversible operations, they may alter a patient's appearance (e.g., maxillo-mandibulary advancement), and/or they may be socially stigmatic (e.g., tracheostomy) and have extensive morbidity. SUMMARY The present disclosure relates generally to a system and methods for treating sleep disorders and, more particularly, to a system and methods for treating obstructive sleep apnea (OSA). One aspect of the present disclosure relates to a system for treating OSA in a subject. The system can comprise a power source and a neuromuscular stimulator in electrical communication with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base and lingual positioning of the tongue of the subject. Another aspect of the present disclosure relates to a method for treating OSA in a subject. One step of the method can include providing a system comprising a power source and a neuromuscular stimulator in electrical communication with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. Next, the neuromuscular stimulator can be implanted in the subject so that the at least one electrode is in electrical communication with a target tissue associated with direct or indirect control of a posterior base of the tongue and posterior oropharyngeal airway of the subject. The power source can then be activated so that the therapy signal is delivered to the at least one electrode for a time and in an amount sufficient to open the oropharyngeal airway to the laryngeal introitus. Another aspect of the present disclosure relates to a method for treating OSA in a subject. One step of the method can include providing a closed-loop system comprising a power source, a neuromuscular stimulator, and a sensing component. The neuromuscular stimulator can be in electrical communication with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and data associated with a therapy signal from the power source. The sensing component can be configured to detect at least one physiological parameter or a related symptom associated with OSA. Next, the system can be implanted in the subject so that the at least one electrode and the sensing component are in electrical communication with target tissue, such as first and second target tissues, respectively, associated with direct or indirect control of a posterior base of the tongue and posterior oropharyngeal airway of the subject. A sensor signal can then be generated by the sensing component based on a detected at least one physiological parameter or a related symptom associated with OSA. The controller can activate the neuromuscular stimulator to adjust application of the therapy signal to the first target tissue in response to the sensor signal to treat the OSA. Another aspect of the present disclosure relates to a method for treating a sleep breathing disorder in a subject suffering therefrom. One step of such a method