# US 12,685,865 B2 · Systems and methods for treating obstructive sleep apnea with automatic starts and stops > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,685,865 B2 - Document ID: US12685865B2 - Status: Granted - Kind: B2 - Application number: 18/394,314 - Filed: 2023-12-22 - Published: 2024-08-08 - Granted: 2026-07-21 - Earliest claimed: 2023-02-07 - Assignees: Alfred E. Mann Foundation for Scientific Research - Applicants: The Alfred E. Mann Foundation for Scientific Research - Inventors: Brian Shelton; Robert J. Greenberg - Web page: https://patentgrep.com/patent/US12685865B2 ## CPC - A61N 1/36139: {with automatic adjustment} - A61B 5/1116: {Determining posture transitions} - A61B 5/113: occurring during breathing - A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not} - A61B 5/4818: {Sleep apnoea} - A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)} - A61N 1/3601: {of respiratory organs} - A61N 1/3611: {Respiration control (stimulating respiratory organs A61N1/3601)} - A61N 1/3615: {Intensity} - A61N 1/36175: {Pulse width or duty cycle} - A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches - 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 The present disclosure generally relates to systems and methods for detecting and/or treating obstructive sleep apnea (OSA) experienced by a subject, using one or more implanted or external sensors. In some aspects, the systems and methods described herein are configured to classify the human subject as being awake or asleep by comparing a calculated standard deviation and/or variance of one or more respiratory parameters against a predetermined threshold and to control the delivery of stimulation based on this classification. ## Claims ### Claim 1 A implantable system for treating obstructive sleep apnea (OSA) in a human subject, comprising: an inertial measurement unit (IMU); and a controller communicatively linked to the IMU and configured to: receive sensor data from the IMU, and determine a position of the human subject from the sensor data; and a stimulation system, communicatively linked to the controller and configured to deliver stimulation to a nerve which innervates an upper airway muscle of the human subject; wherein the stimulation system is configured to activate the delivery of stimulation to the nerve when the controller detects a transition in the position of the human subject. ### Claim 2 (depends on 1) The system of claim 1, wherein the IMU is an accelerometer. ### Claim 3 (depends on 1) The system of claim 1, wherein the controller is further configured to cause the stimulation system to stop or prevent the delivery of stimulation when the human subject is determined to be in an upright, standing, or sitting position. ### Claim 4 (depends on 1) The system of claim 1, wherein the controller is further configured to: maintain a real-time clock; temporarily pause the delivery of stimulation when the human subject is determined to have switched to an upright, standing, or sitting position during a preset time range; and to resume the delivery of stimulation when the human subject is determined to have returned to a supine, prone or lateral recumbent position. ### Claim 5 (depends on 1) The system of claim 1, wherein the controller is further configured to cause the stimulation system to activate the delivery of stimulation based on a preset schedule, wherein the preset schedule comprises a) a time of day to enter a first mode of operation, b) a time of day to exit the first mode of operation, and c) a first delay timer setting comprising an amount of time to wait before activating the delivery of stimulation, after entering the first mode of operation; and the first mode of operation comprises a state wherein the controller is further configured to cause the stimulation system to activate the delivery of stimulation when the human subject is determined to have entered a supine, prone or lateral recumbent position, after the first delay time has elapsed. ### Claim 6 (depends on 5) The system of claim 5, wherein the controller is further configured to cause the stimulation system to gradually increase a pulse amplitude of the delivered stimulation, upon activation. ### Claim 7 (depends on 5) The system of claim 5, wherein the controller is further configured to determine the position of the human subject periodically while in the first mode of operation and to enter a second mode of operation when the human subject is determined to have switched to an upright, standing, or sitting position; and the second mode of operation comprises a state wherein the controller is configured to cause the stimulation system to pause the delivery of stimulation, and to resume the delivery of stimulation after the human subject is determined to have returned to a supine, prone or lateral recumbent position. ### Claim 8 (depends on 7) The system of claim 7, wherein the controller is further configured to cause the stimulation system to resume the delivery of stimulation in the second mode of operation after a preset second delay timer. ### Claim 9 (depends on 1) The system of claim 1, wherein the controller is further configured to cause the stimulation system to deliver stimulation to the nerve which innervates an upper airway muscle of the human subject: a) after determining that the human subject is asleep and detecting transition from a supine position from a prone or lateral position; or b) after determining that the human subject is asleep and detecting that the human subject has remained in a supine position for a minimum duration. ### Claim 10 (depends on 9) The system of claim 9, wherein the controller is further configured to determine that the human subject has rolled on their back based on the sensor data collected by one or more sensors. ### Claim 11 (depends on 9) The system of claim 9, wherein the controller is further configured to cause the stimulation system to deliver stimulation to the nerve which innervates an upper airway muscle of the human subject only while the human subject is in a supine position. ### Claim 12 (depends on 1) The system of claim 1, wherein the controller is further configured to receive, from a clinician or the human subject, a selection of one or more settings for the delivery of stimulation, wherein the one or more settings comprise a setting allowing or prohibiting the delivery of the stimulation based on a position of the human subject. ### Claim 13 (depends on 12) The system of claim 12, wherein the one or more settings comprise a setting allowing or prohibiting the delivery of the stimulation when the human subject is determined to be in a supine, prone, or lateral position. ### Claim 14 (depends on 12) The system of claim 12, wherein the one or more settings comprise a) a duty cycle of the stimulation; or b) a pulse amplitude of the stimulation. ### Claim 15 (depends on 1) The system of claim 1, wherein the controller is further configured to cause the stimulation system to activate the delivery of stimulation to the nerve after a time delay from when the controller detects that the subject is in a recumbent position during a preset time window and pause the delivery of stimulation to the nerve when the subject transitions to an upright position. ### Claim 16 A method for treating obstructive sleep apnea (OSA) in a human subject comprising: collecting sensor data indicative of respiratory activity or a physical state of the human subject using at least an inertial measurement unit (IMU) implanted in the human subject; receiving the sensor data from the IMU; determining a position of the human subject from the sensor data; delivering stimulation to a nerve which innervates an upper airway muscle of the human subject using a stimulation system; and activating, using the stimulation system, the delivery of stimulation to the nerve upon a detection of a transition in the position of the human subject. ### Claim 17 (depends on 16) The method of claim 16, wherein the IMU is an accelerometer. ### Claim 18 (depends on 16) The method of claim 16, further comprising: stopping or preventing the delivery of stimulation when the human subject is determined to be in an upright, standing, or sitting position. ### Claim 19 (depends on 16) The method of claim 16, further comprising: maintaining a real-time clock; temporarily pausing the delivery of stimulation when the human subject is determined to have switched to an upright, standing, or sitting position during a preset time range; and to resuming the delivery of stimulation when the human subject is determined to have returned to a supine, prone or lateral recumbent position. ### Claim 20 (depends on 16) The method of claim 16, further comprising: activating the delivery of stimulation based on a preset schedule, wherein the preset schedule comprises a) a time of day to enter a first mode of operation, b) a time of day to exit the first mode of operation, and c) a first delay timer setting comprising an amount of time to wait before activating the delivery of stimulation, after entering the first mode of operation; and the first mode of operation comprises a state to activate the delivery of stimulation when the human subject is determined to have entered a supine, prone or lateral recumbent position, after the first delay time has elapsed. ### Claim 21 (depends on 20) The method of claim 20, further comprising: gradually increasing a pulse amplitude of the delivered stimulation, upon activation. ### Claim 22 (depends on 20) The method of claim 20, further comprising: determining the position of the human subject periodically while in the first mode of operation and to enter a second mode of operation when the human subject is determined to have switched to a upright, standing, or sitting position; and the second mode of operation comprises a state to pause the delivery of stimulation, and to resume the delivery of stimulation after the human subject is determined to have returned to a supine, prone or lateral recumbent position. ### Claim 23 (depends on 22) The method of claim 22, further comprising: resuming the delivery of stimulation in the second mode of operation after a preset second delay timer. ### Claim 24 (depends on 16) The method of claim 16, further comprising: causing the stimulation system to deliver stimulation to the nerve which innervates an upper airway muscle of the human subject only after determining that the human subject is asleep and has transitioned to a supine position from a prone or lateral position. ### Claim 25 (depends on 24) The method of claim 24, further comprising: determining that the subject has rolled on their back based on the collected sensor data. ### Claim 26 (depends on 24) The method of claim 24, further comprising: delivering stimulation to the nerve which innervates an upper airway muscle of the human subject only while the human subject is in a supine position. ### Claim 27 (depends on 16) The method of claim 16, further comprising: obtaining, from a clinician or the human subject, a selection of one or more settings for the delivery of stimulation, wherein the one or more settings comprise a setting allowing or prohibiting the delivery of the stimulation based on a position of the human subject. ### Claim 28 (depends on 27) The method of claim 27, wherein the one or more settings comprise a setting allowing or prohibiting the delivery of the stimulation when the human subject is determined to be in a supine, prone, or lateral position. ### Claim 29 A implantable system for treating obstructive sleep apnea (OSA) in a human subject, comprising: one or more sensors, wherein each sensor is configured to collect sensor data indicative of respiratory activity or a physical state of the human subject when placed on, in proximity to, or implanted in, the human subject; and a controller communicatively linked to the one or more sensors and configured to; receive the sensor data from the one or more sensors, determine one or more respiratory parameters for the human subject, using the sensor data, calculate a standard deviation or a variance of the one or more respiratory parameters over a trailing window comprising 75-120 time points or a time range of 5-8 minutes, and classify the human subject as being awake or asleep by comparing the calculated standard deviation or a variance against a predetermined threshold; and a stimulation system, communicatively linked to the controller and configured to deliver stimulation to a nerve which innervates an upper airway muscle of the human subject based on the classification by the controller, wherein the controller is configured to cause the stimulation system to activate the delivery of stimulation to the nerve when the controller detects a transition in the position of the human subject.