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US-20260124452-A1 - SYSTEMS AND METHODS FOR TREATING SLEEP DISORDERED BREATHING

US20260124452A1US 20260124452 A1US20260124452 A1US 20260124452A1US-20260124452-A1

Abstract

Methods and systems of treating sleep disordered breathing in a patient suffering therefrom by activating one or more infrahyoid strap muscles are provided. Activation of one or more infrahyoid muscles can be accomplished by stimulating an ansa cervicalis, including one or both of the superior root and the inferior root of the ansa cervicalis, alone or in combination with stimulating the hypoglossal nerve.

Inventors

  • David T. Kent

Assignees

  • VANDERBILT UNIVERSITY

Dates

Publication Date
20260507
Application Date
20251218

Claims (17)

  1. 1 - 12 . (canceled)
  2. 13 . A therapy delivery system to improving sleep disordered breathing comprising: an ultrasound energy source; and a controller in ultrasound communication with the ultrasound energy source and programmed to direct delivery of at least one ultrasound signal proximate an ansa cervicalis to stimulate the ansa cervicalis and activate a sternothyroid muscle to improve the sleep disordered breathing.
  3. 14 . The therapy delivery system of claim 13 , further comprising: the controller programmed to direct delivery of the at least one ultrasound signal proximate to the ansa cervicalis to stimulate the ansa cervicalis and activate a sternohyoid muscle.
  4. 15 . The therapy delivery system of claim 13 , further comprising: the controller programmed to direct delivery of the at least one ultrasound signal proximate to the ansa cervicalis to stimulate the ansa cervicalis and activate an omohyoid muscle.
  5. 16 . The therapy delivery system of claim 14 , further comprising: the controller programmed to direct delivery of the at least one ultrasound signal proximate to the ansa cervicalis to stimulate the ansa cervicalis and activate an omohyoid muscle.
  6. 17 . The therapy delivery system of claim 13 , further comprising: the controller being programmed to direct delivery of the at least one ultrasound signal to a hypoglossal nerve to activate a genioglossus muscle.
  7. 18 . The therapy delivery system of claim 13 , further comprising a sensor configured to sense a physiological parameter indicative of a presence, onset or extent of the sleep disordered breathing.
  8. 19 . The system of claim 18 , wherein the controller is programmed to activate the ultrasound energy source in response to the sensed physiological parameter to improve the sleep disordered breathing.
  9. 20 . The system of claim 18 , wherein the sensor is configured to detect a sleep disordered breathing event and the controller is programmed to activate the ultrasound energy source to activate or pace respiration after detection of the sleep disordered breathing event.
  10. 21 . A method of improving sleep disordered breathing in a patient suffering therefrom comprising: obtaining the system of claim 13 ; delivering the at least one ultrasound signal proximate to the ansa cervicalis to stimulate the ansa cervicalis innervating the sternothyroid muscle; activating the sternothyroid muscle; and improving the patient's sleep disordered breathing via delivery of the at least one ultrasound signal.
  11. 22 . The method of claim 21 , further comprising: delivering the at least one ultrasound signal proximate to the ansa cervicalis to stimulate the ansa cervicalis innervating a sternohyoid muscle; and activating the sternohyoid muscle.
  12. 23 . The method of claim 21 , wherein proximate to the ansa cervicalis comprises proximal to or at a branch point of a superior root of the ansa cervicalis.
  13. 24 . The method of claim 21 , wherein proximate to the ansa cervicalis comprises proximate to an inferior root of the ansa cervicalis.
  14. 25 . The method of claim 21 , further comprising: delivering the at least one ultrasound signal proximate to the ansa cervicalis to stimulate the ansa cervicalis innervating an omohyoid muscle; and activating the omohyoid muscle.
  15. 26 . The method of claim 21 , further comprising: delivering the at least one ultrasound signal proximate to a hypoglossal nerve innervating a genioglossus muscle; and activating the genioglossus muscle.
  16. 27 . The method of claim 22 , further comprising: delivering the at least one ultrasound signal proximate to a hypoglossal nerve innervating a genioglossus muscle; and activating the genioglossus muscle.
  17. 28 . The method of claim 27 , wherein proximate to the hypoglossal nerve comprises distal to or at a branch point of the hypoglossal nerve and a superior root of the ansa cervicalis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority to U.S. Provisional Application No. 62/843,641 filed on May 6, 2019 and U.S. Provisional Application No. 62/815,393 filed on Mar. 8, 2019, both of which are incorporated by reference herein. TECHNICAL FIELD The present disclosure relates to methods and systems for treating sleep disordered breathing by activating infrahyoid strap muscles via neuromodulation. BACKGROUND Sleep disordered breathing (SDB) occurs when there is a partial or complete cessation of breathing that occurs many times throughout the night. Obstructive sleep apnea (OSA) is a type of SDB that involves cessation or significant decrease in airflow in the presence of breathing effort. It is the most common type of SDB and is characterized by recurrent episodes of upper airway collapse during sleep inducing repetitive pauses in breathing followed by reductions in blood oxygen saturation or neurologic arousal. The pathophysiology of OSA can involve factors such as craniofacial anatomy, airway collapsibility, and neuromuscular control of the upper airway dilator musculature. Electromyogram studies have shown that the tonic and phasic activity of the pharyngeal airway dilatory muscles (such as the genioglossus muscle) is progressively reduced from wakefulness to non-rapid eye movement to rapid eye movement. Continuous positive airway pressure (CPAP) therapy is the frontline treatment for OSA. CPAP therapy utilizes machines, generally including a flow generator, tubing, and a mask designed to deliver a constant flow of air pressure to keep the airways continuously open in patients with OSA. However, the success of CPAP therapy is limited by compliance with reported rates ranging from 50% to 70%. Hypoglossal nerve stimulation (HNS) has now been established as an effective form of therapy for patients with obstructive sleep apnea (OSA) who are unable to tolerate positive airway pressure. This therapy works by protruding and stiffening the tongue muscle thereby dilating the pharyngeal airway. However, only a small subset of patients with OSA have anatomy suitable for hypoglossal nerve stimulation therapy, as many patients continue to suffer from airway collapse even with stimulation of hypoglossal nerve musculature. SUMMARY The present disclosure relates to methods and systems for treating SDB in a patient suffering therefrom by activating infrahyoid strap muscles via neuromodulation. In an aspect, a method for improving SDB in a patient suffering therefrom comprises delivering a neuromodulation signal to a target site proximate to an ansa cervicalis that innervates a sternothyroid muscle and activating the sternothyroid muscle to improve the patient's SDB. In another aspect, a method for improving SDB in a patient suffering therefrom comprises delivering a neuromodulation signal to a target site proximate to an ansa cervicalis that innervates a sternothyroid muscle to activate the sternothyroid muscle. The method further involves delivering a neuromodulation signal to a target site proximate to a hypoglossal nerve (HGN) to activate a genioglossus muscle. Delivery of the neuromodulation signals can improve the patient's SDB. Aspect of the present disclosure can further include delivering a neuromodulation signal to a target site proximate to an ansa cervicalis that innervates a sternohyoid muscle to activate the sternohyoid muscle to improve the patient's SDB. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a flow chart depicting illustrative steps of a method of improving SDB in a patient suffering therefrom. FIG. 2 is a schematic illustration of exemplary target sites for neuromodulation according to an aspect of the present disclosure. FIG. 3 is a schematic illustration of exemplary target sites for neuromodulation according to an aspect of the present disclosure. FIG. 4 is a flow chart depicting illustrative steps of a method of improving SDB in a patient suffering therefrom according to an aspect of the present disclosure. FIG. 5 is block diagram depicting illustrative components of a neuromodulation system according to an aspect of the present disclosure. FIG. 6 is a block diagram depicting illustrative components of a neuromodulator according to an aspect of the present disclosure. DETAILED DESCRIPTION The present disclosure relates to systems and methods for improving SDB by activating one or more infrahyoid strap muscles. Non-limiting examples of SDBs are increased upper airway resistance including snoring; upper airway resistance syndrome (UARS); and sleep apnea. Sleep apnea can include OSA, central sleep apnea (CSA), and mixed sleep apnea. As used herein with respect to a described element, the terms “a,” “an,” and “the” include at least one or more of the described element unless otherwise indicated. Further, the terms “or” and “and” refer to “and/or” and combinations thereof unless otherwise indicated. Reference to “improving” a patient's SDB includes treating,