# US 10,946,195 B2 · System and method for ensuring airway patency when asleep > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,946,195 B2 - Document ID: US10946195B2 - Status: Granted - Kind: B2 - Application number: 15/553,223 - Filed: 2016-03-14 - Published: 2018-01-18 - Granted: 2021-03-16 - Earliest claimed: 2015-03-13 - Assignees: Case Western Reserve University - Applicants: Case Western Reserve University - Inventors: Kingman P. Strohl - Web page: https://patentgrep.com/patent/US10946195B2 ## CPC - A61N 1/36034: {specified by the stimulation parameters} - A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)} - A61N 1/0502: {Skin piercing electrodes} - A61N 1/0517: {Esophageal electrodes} - A61N 1/3601: {of respiratory organs} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/36057: {adapted for stimulating afferent nerves} - A61N 1/3611: {Respiration control (stimulating respiratory organs A61N1/3601)} - A61B 5/4818: {Sleep apnoea} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract One aspect of the present disclosure relates to a system that provides an alternative to traditional treatments for sleep apnea. The system allows to apply an electrical stimulus through an electrode to stimulate an afferent nerve fiber while a patient is sleeping. The system also includes activating an endogenous central nervous system (CNS)-regulated reflex response to coordinate upper airway muscles based on the stimulation of the afferent nerve fiber. Based on the endogenous CNS-regulated reflex response, an airway patency in the sleeping patient can be regulated. ## Claims ### Claim 1 A method comprising: applying an electrical stimulus through an electrode to stimulate an afferent nerve fiber within a sciatic nerve or a vagus nerve while a patient is sleeping; activating an endogenous central nervous system (CNS)-regulated reflex response that modulates respiratory bursting in the sleeping patient based on the stimulation of the afferent nerve fiber; and regulating airway patency in the sleeping patient based on an endogenous CNS-regulated reflex response. ### Claim 2 (depends on 1) The method of claim 1, wherein the electrode is a temporary electrode that is removable after the patient wakes up. ### Claim 3 (depends on 2) The method of claim 2, wherein the electrode is a skin electrode, a transcutaneous electrode, a transmucosal electrode, or an intra-esophageal electrode. ### Claim 4 (depends on 1) The method of claim 1, wherein the airway patency is regulated to ensure that the patient's airway remains open during sleep. ### Claim 5 (depends on 4) The method of claim 4, wherein the patient suffers from obstructive sleep apnea or central sleep apnea. ### Claim 6 (depends on 1) The method of claim 1, wherein the afferent nerve fiber is located within a nerve that relays peripheral information to the CNS to trigger a reflex that results in the endogenous CNS-regulated reflex response. ### Claim 7 (depends on 1) The method of claim 1, wherein the electrical stimulus comprises a strength parameter, a frequency parameter, and a duration parameter sufficient to activate the endogenous CNS-regulated reflex response. ### Claim 8 (depends on 7) The method of claim 7, wherein the frequency parameter is from 5 Hz to 100 Hz and the duration parameter is from 0.1 ms to 10 ms. ### Claim 9 (depends on 1) The method of claim 1, wherein a flow resistance in the sleeping patient is reduced by the CNS-regulated reflex response, mimicking conditions when the patient is awake. ### Claim 10 A system comprising: a signal generator programmed to generate an electrical therapy signal comprising a strength parameter, a frequency parameter, and a duration parameter sufficient to activate an endogenous CNS-regulated reflex response; and an electrode, coupled to the signal generator, to apply the electrical therapy signal to an afferent nerve fiber of a peripheral nerve of a sleeping patient to activate the endogenous CNS-regulated reflex response to regulate airway patency in the sleeping patient, wherein the peripheral nerve is a sciatic nerve or a vagus nerve, and wherein a response to the endogenous CNS-regulated reflex modulates respiratory bursting in the sleeping patient. ### Claim 11 (depends on 10) The system of claim 10, wherein the electrode is a skin electrode, a transcutaneous electrode, a transmucosal electrode, or an intra-esophageal electrode. ### Claim 12 (depends on 10) The system of claim 10, wherein the endogenous CNS-regulated reflex response regulates at least one efferent nerve-muscle unit that opens at least a portion of the airway of the sleeping patient to contribute to the airway patency. ### Claim 13 A method comprising: applying a temporary electrode configuration to a patient before sleep, wherein the temporary electrode configuration is coupled to a stimulator; during sleep, delivering an electrical stimulus through the temporary electrode configuration to stimulate an afferent nerve fiber of a sciatic nerve or a vagus nerve; and based on the electrical stimulus, activating an endogenous brainstem-regulated reflex to ensure that the patient's airway remains open during sleep; wherein a response to the endogenous CNS-regulated reflex modulates respiratory bursting in the sleeping patient. ### Claim 14 (depends on 13) The method of claim 13, wherein the endogenous CNS-related reflex regulates at least one of a CN V muscle, X muscle, IX muscle, and XII muscle. ### Claim 15 (depends on 13) The method of claim 13, wherein the electrode configuration comprises a skin electrode, a transcutaneous electrode, a transmucosal electrode, or an intra-esophageal electrode. ### Claim 16 (depends on 13) The method of claim 13, wherein the sleeping patient suffers from obstructive sleep apnea or central sleep apnea.