# US 10,307,328 B2 · Device for discrimination of stages of a patient's sleep > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,328 B2 - Document ID: US10307328B2 - Status: Granted - Kind: B2 - Application number: 14/617,514 - Filed: 2015-02-09 - Published: 2015-08-13 - Granted: 2019-06-04 - Earliest claimed: 2014-02-11 - Assignees: Sorin Crm SAS; Universite Joseph Fourier - Grenoble 1; Inserm (Institut National De La Sante Et De La Recherche Medicale); Universite Rennes 1 - Applicants: Sorin Crm SAS; Inserm—Institut National De La Sante Et De La Recherche Medicale; Université De Rennes 1; Universite Joseph Fourier—Grenoble 1 - Inventors: Laurence Graindorge; Amel Amblard; Christine Henry; Marcel Limousin; Laure Duchemin Laporte; Alfredo Hernandez; Jean-Louis Pépin - Web page: https://patentgrep.com/patent/US10307328B2 ## CPC - A61H 23/00: Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms {(apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B)} - A61B 5/02405: {Determining heart rate variability} - A61B 5/4812: {Detecting sleep stages or cycles} - A61B 5/4818: {Sleep apnoea} - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61H 23/02: with electric or magnetic drive - A61B 5/332: Portable devices specially adapted therefor - A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not} - A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems} - A61H 2201/165: Wearable interfaces - A61H 2230/04: Heartbeat characteristics, e.g. E.G.C., blood pressure modulation - A61H 2230/06: Heartbeat rate - A61M 2021/0022: {by the tactile sense, e.g. vibrations} - A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation - A61M 2230/06: Heartbeat rate only - A61M 2230/40: Respiratory characteristics - A61M 2230/63: Motion, e.g. physical activity - A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A device for treating sleep apnea by discriminating between successive sleep stages of a patient includes a generator configured to produce stimulation pulses, a stimulator that receives the stimulation pulses produced by the generator and delivers stimulation to the patient, a sensor configured to measure a biological parameter of the patient, and a controller. The controller is configured to determine a state of the patient based on the biological parameter, perform a sleep analysis based on the state of the patient, activate the generator to trigger production of the stimulation pulses, determine a variation of the biological parameter subsequent to the production of the stimulation pulses, determine a response of the patient to the stimulation pulses according to the variation of the biological parameter, and determine a sleep stage of the patient based on the response. ## Claims ### Claim 1 A device for treating sleep apnea by discriminating between successive sleep stages of a patient, comprising: a generator configured to produce kinesthetic stimulation pulses; a kinesthetic effector adapted to be applied to an external skin site of the patient that receives the kinesthetic stimulation pulses produced by the generator and is adapted to deliver kinesthetic stimulation to the patient; a sensor configured to measure a biological parameter of the patient; and a controller configured to: detect a presence of the sleep apnea; in response to detecting the presence of the sleep apnea, determine a state of the patient based on the biological parameter; perform a sleep analysis based on the state of the patient; activate the generator to trigger production of the kinesthetic stimulation pulses based on the state of the patient and the presence of the sleep apnea; determine a variation of the biological parameter subsequent to the production of the kinesthetic stimulation pulses; determine a response of the patient to the kinesthetic stimulation pulses according to the variation of the biological parameter; determine a sleep stage of the patient based on the response; determine an effectiveness of the kinesthetic stimulation pulses in treating the sleep apnea based on the response; and modulate a stimulation energy of the kinesthetic stimulation pulses produced by the generator based on the determined sleep stage and the effectiveness of the kinesthetic stimulation pulses in treating the sleep apnea, the controller configured to increase the stimulation energy of the kinesthetic stimulation pulses in response to determining the kinesthetic stimulation pulses are ineffective in treating the sleep apnea to a level sufficient to stop the sleep apnea and low enough to limit an occurrence of micro-awakenings of the patient. ### Claim 2 (depends on 1) The device of claim 1, wherein the controller is configured to control the kinesthetic stimulation delivered to the patient in response to the determined sleep stage. ### Claim 3 (depends on 1) The device of claim 1, wherein the state of the patient is either an awake state or a sleep state, wherein the sleep state includes a plurality of sleep stages including slow-wave sleep I, slow-wave sleep II, slow-wave sleep III, slow-wave sleep IV, and REM sleep. ### Claim 4 (depends on 3) The device of claim 3, wherein the controller performs the sleep analysis in the presence of the sleep state. ### Claim 5 (depends on 4) The device of claim 4, wherein the controller is configured to establish a level of a kinesthetic stimulation parameter of the kinesthetic stimulation pulses based on the sleep stage, wherein the kinesthetic stimulation parameter includes at least one of an amount of the stimulation energy delivered, a duration of the kinesthetic stimulation pulses, a pulse repetition frequency, and a unitary pulse duration. ### Claim 6 (depends on 5) The device of claim 5, wherein the controller is configured to: initialize the level of the kinesthetic stimulation parameter to a default value; compare a current response to a first threshold of the response; and iteratively change the level of the kinesthetic stimulation parameter until the current response is less than the first threshold. ### Claim 7 (depends on 1) The device of claim 1, wherein the biological parameter of the patient is at least one of a current heart rate of the patient, a respiratory rate, a blood oxygen saturation, and a derivative parameter from a phonocardiographic signal or an endocardial acceleration signal. ### Claim 8 (depends on 1) The device of claim 1, wherein the controller is configured to reiteratively perform the sleep analysis, wherein the controller compares a current response of the patient with a previous response of the patient, and wherein the controller determines whether the difference between the current response and the previous response exceeds a second threshold. ### Claim 9 (depends on 8) The device of claim 8, wherein the controller is configured to determine the sleep stage relative to a previously determined sleep stage based on the difference between the current response and the previous response. ### Claim 10 (depends on 9) The device of claim 9, wherein the controller is configured to update the sleep stage based on the difference between the current response and the previous response, wherein the controller raises the sleep stage in response to a reduction of the difference between the current response and the previous response, and vice versa. ### Claim 11 (depends on 9) The device of claim 9, wherein the controller is configured to implement a stochastic automaton with a finite number of states whose transitions are defined by a Markov or semi-Markov process. ### Claim 12 (depends on 1) The device of claim 1, wherein the controller is configured to evaluate the effectiveness of the kinesthetic stimulation pulses in treating sleep apnea by determining whether the kinesthetic simulation pulses cause a recovery of breathing indicating a stop of the sleep apnea. ### Claim 13 (depends on 1) The device of claim 1, wherein the controller is configured to evaluate the effectiveness of the kinesthetic stimulation pulses in treating sleep apnea by counting a number of sleep apnea events over a time period, comparing the number of sleep apnea events to historical data for the patient, and determining the effectiveness based on whether the counted number of sleep apnea events to historical data indicates a decrease in number of counted events. ### Claim 14 (depends on 1) The device of claim 1, wherein the kinesthetic effector comprises a vibrating electromechanical transducer. ### Claim 15 (depends on 1) The device of claim 1, wherein the kinesthetic effector comprises a vibrator adapted to be disposed in a region of a mastoid bone in a vicinity of an ear of the patient. ### Claim 16 (depends on 1) The device of claim 1, wherein the kinesthetic effector is configured to generate the kinesthetic stimulation pulses at a frequency of approximately 250 Hz. ### Claim 17 (depends on 1) The device of claim 1, wherein the stimulation energy of the kinesthetic stimulation pulses is increased incrementally by one step and up to a predetermined maximum corresponding to a limit that could cause the occurrence of micro-awakenings of the patient. ### Claim 18 A method of using a determination of sleep stages of a patient to treat sleep apnea, comprising: acquiring, by a sensor, a biological parameter of the patient; detecting, by a controller, a presence of the sleep apnea; determining, by the controller, a state of the patient based on the biological parameter in response to detecting the presence of the sleep apnea; delivering, by a kinesthetic effector adapted to be applied to an external skin site of the patient, kinesthetic stimulation pulses to the patient based on the state of the patient and the presence of the sleep apnea; determining, by the controller, a variation of the biological parameter subsequent to the delivery of the kinesthetic stimulation pulses; determining, by the controller, a response of the patient to the kinesthetic stimulation pulses according to the variation of the biological parameter; determining, by the controller, a sleep stage of the patient based on the response; determining, by the controller, an effectiveness of the kinesthetic stimulation pulses in treating the sleep apnea based on the response; modulating, by the controller, a stimulation energy of the kinesthetic stimulation pulses based on the determined sleep stage and in response to determining the kinesthetic stimulation pulses are ineffective in treating the sleep apnea to a level sufficient to stop the sleep apnea and low enough to limit an occurrence of micro-awakenings of the patient. ### Claim 19 (depends on 18) The method of claim 18, further comprising: establishing, by the controller, a level of a kinesthetic stimulation parameter of the kinesthetic stimulation pulses based on the sleep stage, wherein the kinesthetic stimulation parameter includes at least one of an amount of the stimulation energy delivered, a duration of the kinesthetic stimulation pulses, a pulse repetition frequency, and a unitary pulse duration; activating, by the controller, a generator to trigger production of the kinesthetic stimulation pulses based on the state of the patient; and controlling, by the controller, the kinesthetic stimulation pulses delivered to the patient in response to the determined sleep stage. ### Claim 20 (depends on 19) The method of claim 19, further comprising: initializing, by the controller, the level of the kinesthetic stimulation parameter to a default value; comparing, by the controller, a current response of the patient to a first threshold; and iteratively changing, by the controller, the level of the kinesthetic stimulation parameter until exceeding the first threshold based on the current response being less than the first threshold. ### Claim 21 (depends on 18) The method of claim 18, wherein the state of the patient is either an awake state or a sleep state, wherein the sleep state includes a plurality of sleep stages including slow-wave sleep I, slow-wave sleep II, slow-wave sleep III, slow-wave sleep IV, and REM sleep. ### Claim 22 (depends on 21) The method of claim 21, wherein the controller performs a sleep analysis in the presence of the sleep state. ### Claim 23 (depends on 18) The method of claim 18, wherein the biological parameter of the patient is at least one of a current heart rate of the patient, a respiratory rate, a blood oxygen saturation, and a derivative parameter from a phonocardiographic signal or an endocardial acceleration signal. ### Claim 24 (depends on 18) The method of claim 18, further comprising reiteratively performing, by the controller, a sleep analysis, wherein the controller compares a current of the patient with a previous response of the patient, and wherein the controller determines whether the difference between the current response and the previous response exceeds a second threshold. ### Claim 25 (depends on 24) The method of claim 24, further comprising updating, by the controller, the sleep stage relative to a previously determined sleep stage based on the difference between the current response and the previous response. ### Claim 26 A device for treating sleep apnea of a patient, comprising: a generator configured to produce kinesthetic stimulation pulses; a kinesthetic effector configured to receive the kinesthetic stimulation pulses produced by the generator and adapted to deliver kinesthetic stimulation to the patient; a sensor configured to measure a biological parameter of a current activity of the patient; and a controller configured to; perform a sleep analysis on the patient, wherein the controller determines (i) a presence of the sleep apnea, (ii) a variation of the biological parameter subsequent to the production of the kinesthetic stimulation pulses, (iii) a response of the patient to the kinesthetic stimulation pulses according to the variation of the biological parameter, (iv) an effectiveness of the kinesthetic stimulation pulses in treating the sleep apnea based on the response, and (v) a sleep stage of the patient based on the response; and modulate a stimulation energy of the kinesthetic stimulation pulses produced by the generator based on the determined sleep stage and the effectiveness of the kinesthetic stimulation pulses in treating the sleep apnea, the controller configured to increase the stimulation energy of the kinesthetic stimulation pulses in response to determining the kinesthetic stimulation pulses are ineffective in treating the sleep apnea to a level sufficient to stop the sleep apnea and low enough to limit an occurrence of micro-awakenings of the patient.