FR3063424A1 - DEVICE FOR DETECTING AND TREATING SLEEP APNEA SYNDROME AND INTRA-AURICULAR HEAD - Google Patents

Abstract

The device (1) according to the invention comprises at least one in-ear atrium (21, 22) having a pressure sensor and a vibrator, able to be placed in the ear canal of a person, and a station (3) to which the in-ear atrium is connected. The device comprises means distributed between the atrium and the station to obtain a respiratory rhythm signal from a blood pressure signal delivered by the pressure sensor, to detect sleep apnea from the respiratory rhythm signal and to activate the buzzer when an apnea is detected.

Description

® FRENCH REPUBLIC

NATIONAL INSTITUTE OF INDUSTRIAL PROPERTY ® Publication number: 3,063,424 (to be used only for reproduction orders)

©) National registration number: 17 70208

COURBEVOIE © Int Cl ⁸ : A 61 B 5/00 (2017.01), A 61 B 5/02, A 61 M 21/02

A1 PATENT APPLICATION

©) Date of filing: 01.03.17. © Applicant (s): CESI ASSOCIATION - FR. (© Priority: @ Inventor (s): JALLARD MARGAUX, LE BAIL AGNES, LEBRETON AUDREY, RUFFIER OLIVIER, (43) Date of public availability of the RAKOTOARIMANANA MIALY and BUISINE STEPHA- request: 07.09.18 Bulletin 18/36. NIE. ©) List of documents cited in the report preliminary research: Refer to end of present booklet (© References to other national documents ® Holder (s): CESI ASSOCIATION. related: ©) Extension request (s): © Agent (s): CABINET l-PATVAL.

DEVICE FOR SCREENING AND TREATMENT OF SLEEP APNEA SYNDROME AND IN-EAR HEADSET.

FR 3,063,424 - A1 _ The device (1) according to the invention comprises at least one intra-auricular auricle (21,22) having a pressure sensor and a vibrator, capable of being placed in the auricular canal of a person , and a station (3) to which the ear cup is connected. The device comprises means distributed between the atrium and the station for obtaining a respiratory rhythm signal from a blood pressure signal delivered by the pressure sensor, detecting sleep apnea from the respiratory rhythm signal and activating the buzzer when apnea is detected.

DEVICE FOR SCREENING AND TREATING APNEA SYNDROME OF

SLEEP AND IN-EAR EARPHONE

The invention relates to a device for detecting and treating sleep apnea syndrome. The invention also relates to an intra-auricular auricle necessary for the functioning of the device of the invention.

Sleep apnea syndrome is manifested by involuntary breathing interruptions and occurs while the person is asleep. By definition, these interruptions of breathing are called apneas when they last more than ten seconds. Apneas can occur several times a night, at a variable frequency, and have a duration which extends beyond thirty seconds. Doctors consider these apneas to be a health problem when their frequency of occurrence exceeds five per hour. In severe cases, apneas can occur more than thirty times an hour. In the short term, sleep apnea leads in particular to fatigue, headaches, irritability, an increased risk of accident due to a lack of sleep and annoying snoring noise for spouses. In the long term, if left untreated, sleep apnea can have serious health consequences, such as the development of cardiovascular disease or nervous breakdown.

Sleep apnea is therefore a significant health problem, which today remains under-diagnosed and under-treated. The prevalence of sleep apnea in populations is very high and is comparable to that of other chronic diseases such as asthma or diabetes. Sleep apnea can affect adults and children, but its frequency increases sharply with age and overweight.

Polysomnography (PSG) is the benchmark test done while the patient is asleep to diagnose sleep apnea. However, it uses expensive equipment which is inconvenient for patients and which is ill-suited for large-scale screening.

For the treatment of sleep apnea, a device known as continuous positive pressure ventilation treatment is known. This device is recommended for severe apneas and makes it possible to breathe air continuously through the patient's nose, thanks to a mask that the patient wears at night.

An oral appliance called the "mandibular advancement orthosis" is recommended for light or moderate apneas. This dentist-made device is in the form of a molded groove that holds the lower jaw and the tongue forward so as to facilitate the passage of air.

These devices are treatment devices prescribed by doctors which have a high cost and require regular maintenance by qualified persons.

It is desirable to propose a device accessible to the greatest number which would allow people concerned with their health to practice a self-assessment of the quality of their sleep and to carry out a first screening for sleep apnea. It also appears desirable to make available to the greatest number of people a first treatment solution which would allow apnea to be interrupted when it persists beyond a period deemed critical.

According to a first aspect, the invention relates to a device for detecting and treating sleep apnea in a person, comprising at least one intra-auricular auricle having a pressure sensor and a vibrator, capable of being placed in the auricular canal. of the person, and a station to which the ear cup is connected, the device comprising means distributed between the ear cup and the station for obtaining a respiratory rate signal from a blood pressure signal delivered by the pressure sensor, detect sleep apnea from the respiratory rate signal and activate the vibrator when apnea is detected.

According to a particular characteristic of the invention, the vibrator emits a vibration at an infrasonic frequency.

According to another particular characteristic, the in-ear headset and the station are connected by a two-way wireless communication link.

According to yet another particular characteristic, the two-way wireless communication link is a wireless communication link, such as a Bluetooth link (registered trademark).

According to another aspect, the invention also relates to an intra-auricular earpiece able to be included in the device described briefly above and comprising an end piece housing at least one sensor in the form of a pressure sensor and a housing containing a vibrator, an electronic circuit, a power supply and a radio transmitter and receiver for communication with the station.

According to a particular characteristic, the in-ear auricle also includes an acoustic transmitter.

According to another particular characteristic, the power supply source includes induction charging means.

According to another aspect, the invention also relates to a station capable of being included in the device briefly described above and comprising an electronic control unit, a radio transmitter-receiver for communication with the in-ear headset, means of human-machine communication, a communication interface with a computer and a power supply unit, in which the electronic control unit comprises a software module for processing in real time a blood pressure signal delivered by the pressure sensor of the earpiece and get a respiratory rate signal from the blood pressure signal, detect sleep apnea from the respiratory rate signal and activate the vibrator of the earpiece when apnea is detected.

According to a particular characteristic, the electronic control unit comprises data storage means for recording signals detected during the person's sleep and means for analyzing these signals, and the man-machine interface means comprise a display screen intended to display the signals detected.

According to another particular characteristic, the power supply unit includes induction charging means.

Other advantages and characteristics of the present invention will appear more clearly on reading the description below of several particular embodiments with reference to the accompanying drawings, in which:

- Fig. 1 is a block diagram showing the architecture of a device for detecting and treating sleep apnea according to the invention;

- Fig.2 is a simplified view showing an ear cup according to the invention placed in the ear canal;

- Fig.3 is a simplified view, in perspective and exploded, of an intraaural auricle according to the invention;

- Fig.4 is a waveform of a blood pressure signal measured by a pressure sensor included in an earbud according to the invention; and

- Fig.5 is a waveform of a respiratory rate signal obtained from the blood pressure signal.

The hardware architecture and the operation of a particular embodiment 1 of the sleep apnea detection and treatment device according to the invention are now described in detail with reference to FIGS. 1 to 5.

With particular reference to FIG. 1, the device 1 comprises at least one in-ear device 2, here called “in-ear headset”, and a fixed unit 3 called “station” thereafter. According to the invention, the device 1 may include several in-ear atria, for example, as shown in Fig.1, two atria 2i and 2 ₂ to equip two people living under the same roof.

As shown in FIG. 2, the in-ear atrium 2i, 2 ₂ is intended to be housed in the atrial canal 40 of the external ear 4, between the pavilion 41 and the eardrum 42. A mouthpiece 20 of the atrium 2i, 2 ₂ is introduced into the ear canal 40.

The in-ear headset 2i, 2 ₂ and the station 3 are linked together by a wireless link L23i, L23 ₂ , typically a link of the local wireless type, for example of the Bluetooth type.

In this embodiment, the radio links L23i, L23 ₂ are established in point-to-point mode between the in-ear atria 2i, 2 ₂ and the station 3. The topology of the radio network is of star type and allows communication bidirectional between a headset 2i, 2 ₂ and the station 3. Preferably, a standard protocol of the OSI type with seven layers will be used to implement a radio network allowing simultaneous communications between the station 3 and the in-ear headsets 2i, 2 ₂ and a cohabitation between the in-ear atria. However, a proprietary communication protocol is not excluded and could be implemented in certain applications of the invention.

The different in-ear atria, here 2i, and 2 ₂ , have an identical architecture. The in-ear atrium 2i, 2 ₂ is now described below with reference more particularly to FIG. 3.

The headset 2i, 2 ₂ essentially comprises an in-ear tip 20, a miniature vibrator 21, an acoustic transmitter 22, an electronic circuit 23, an RF transceiver 24, a source of electrical power 25, and a cap forming a housing 26 .

The in-ear tip 20 is typically an essentially silicone tip. As shown in Fig.3, in the tip 20 is housed a pressure sensor 200. Depending on the applications, different miniature sensors can also be integrated in the tip 20, such as a temperature sensor, an accelerometer, a gyroscope, an oximeter, a blood pressure monitor and micro-electroencephalogram sensors. It will be noted that the end piece 20 has an internal conduit 201 passing through it which allows the propagation of mechanical waves.

The miniature vibrator 21 is a vibrating device with a degree of freedom such as the vibrators fitted to portable telephones. When the vibrator 21 is activated, it emits a mechanical vibration wave in the direction of the in-ear tip 20. The frequency of the vibratory wave emitted is typically 20 Hz here, that is to say, the frequency inaudible threshold of infrasound. The vibrator 21, when activated, therefore emits tactile stimulation in the ear which remains inaudible.

The acoustic transmitter 22 is a miniature audio transmitter operating in the human audible band, that is, frequencies between 20 Hz and 20 KHz. Typically, this is an acoustic transmitter of the type included in wireless headphones, for example, with a Bluetooth connection.

The electronic circuit 23 typically comprises a microcontroller which essentially performs measurement, signal processing and control functions for the various electronic components of the atrium 2i, 22. Thus, the measurement signal supplied by the sensor 200 is filtered, amplified , digitized and coded by the circuit 23 before being transmitted to the station 3 through the RF transceiver 24 and the RF link L23i, L232. In the other direction of transmission, the atrium 2i, 22 receives, through the RF transceiver 24 and the RF link L23i, L232, audio signals intended for the acoustic transmitter 22 and commands which are processed by the electronic circuit 23.

The RF 24 transceiver here is a conventional Bluetooth transceiver such as those included in the well-known wireless micro-earphones in mobile telephony. It allows the establishment of a bidirectional RF link L23i, L232 between the headset 2i, 22 and the station 3.

The electrical power source 25 supplies electrical energy to all of the electronic components of the headset 2i, 22. It typically comprises a rechargeable Li-lon type battery. Preferably, an induction charging circuit is provided for wireless charging of the battery. The battery is then charged automatically by placing the headset 2i, 22 at a dedicated charging location on station 3.

The cap 26 is made of plastic. The cap 26 comprises a housing part 260 which fits with a corresponding part 202 of the end piece 20, so as to form a housing adapted to contain all of the electronic components.

The station 3 here essentially comprises an electronic control unit such as a microcontroller 30, man-machine interface means 31, an RF transceiver 32, a USB port interface 33, a Wi-Fi transceiver 34 and a power supply unit 35.

The microcontroller 30 notably comprises a processing unit in the form of a microprocessor, a read only memory and a random access memory and input / output interface means, these various known components of a microcontroller not being shown in Fig. 1.

A software module 300 is installed in the microcontroller 30 and controls the operation of the station 3.

In this embodiment of the invention, the machine interface means 31 comprise a display screen 310 for example of the LCD or LED type and keys 311. The functions of the keys 311 may possibly be ensured by the screen 310 when a touch screen is chosen for it.

The RF transceiver 32 is controlled by the microcontroller 30 through its input / output interface means and authorizes the establishment of the radio communication links L23i, L232 with the earphones 2i, 22. As shown in FIG. 1, the transceiver 32 is equipped with an antenna 320. The transceiver 32 is, of course, of the same Bluetooth type as the transceiver 24 of the in-ear auricles 2i, 22. L antenna 320 is typically of the “microstrip” type and is produced directly on the printed circuit of the station 3. The transceiver 24 of the in-ear auricles 2i, 22, also includes a similar antenna of the “microstrip” type.

The USB 33 port interface is classic. It authorizes a wired connection of the station 3 with a computer 5 or other means such as a tablet or a so-called "smartphone", for the establishment of a data communication link L34 between them.

In this embodiment, the Wi-Fi transceiver 34, controlled by the microcontroller 30 through its input / output interface means, allows integration of the station 3 into a home Wi-Fi network. When station 3 is connected to the home WI-FI network, the L34 data communication link from station 3 to computer 5 can be established through the WI-FI network, without the need for the USB interface.

A dedicated software application is installed in the computer 5 and in particular authorizes the configuration of the station 3 and the analysis of measurement data transmitted by the in-ear auricle 2i, 22. In certain applications of the invention, this application software can also be used to download audio files, such as music, to station 3. The audio files will be transmitted to the in-ear headset 2i, 22 for listening via the acoustic transmitter 22. These audio files may for example be relaxation music to promote sleep.

The power supply unit 35 includes a direct current alternating current charger (AC-DC) 350, a direct-to-direct converter 351 (DC-DC) and an electric induction charging unit 352.

The AC-DC 350 charger is suitable for connecting to an alternative electrical supply network, such as the 220 Volt network, and for supplying a rectified direct voltage, for example 5 Volt.

The DC-DC converter 351 authorizes a voltage adaptation by supplying, from the rectified direct voltage supplied by the charger 350, the voltage values required by the various components of station 3.

The electric induction charging unit 352 is a device known to those skilled in the art. It here comprises means for detecting the presence of at least one earpiece 2i, 2 ₂ placed at the charging location of the station 3. When a presence of an earpiece is detected, the unit 352 is activated and a transfer of energy intervenes towards the electrical power source 25 of the atrium. The unit 352 is interfaced with the microcontroller 30, for the transmission of a headset presence detection signal to the microcontroller 30 and the reception of an activation command transmitted by the microcontroller 30. The dialogue with the headsets for load control is carried out via RF links, L23i, L23 ₂ .

Referring more particularly to FIGS. 4 to 5, the operation of the sleep apnea detection and treatment device according to the invention 1 is now described.

Referring to Fig. 4, when the in-ear atrium 2i, 2 ₂ is in place in the atrial canal 40, the pressure sensor 200 measures the blood pressure in the carotid artery which is located near the inner ear.

An example of a waveform of a blood pressure signal PA supplied by the sensor 200 is shown in Fig. 4. The PA signal is an oscillatory signal whose frequency is given by the heartbeat. The PA signal is modulated in amplitude and frequency by breathing.

The blood pressure signal PA is processed by the electronic circuit 23 before being transmitted by the Bluetooth transceiver 25 to the station 3, through the RF link L23i, L23 ₂ .

In station 3, the blood pressure signal PA is analyzed in real time in the microcontroller 300. Algorithms are implemented in software module 300 and processes the signal PA in real time to extract, by AM FM demodulation, a signal heart rate and respiratory rate signal. The AMFM demodulation of a blood pressure signal is dealt with in the article "Extraction of cardiac and respiratory rhythms by AMFM demodulation", Stéphane BRUNO and Pascal SCALART, 19th Colloquium on signal and image processing, 2003, pages 11011104, to which we will refer for more details.

Referring to Fig. 5, when sleep apnea AP occurs, it is detectable in the respiratory rate signal RR which is obtained by demodulation of the blood pressure signal PA. Apnea apnea is qualified when there is a decrease in BA of the respiratory amplitude greater than or equal to 90% for a duration of TA greater than or equal to 10 seconds.

According to the invention, when a decrease in BA of the respiratory amplitude greater than or equal to 90% is detected, the microcontroller 30 measures the duration TA of this decrease in BA. If the duration TA reaches TAws = 10 s, the microcontroller 30 delivers a CD command which is transmitted to the atrium 2i, 22 via the RF link L23i, L232. The CD command is a command to activate the vibrator 21. The vibrator 21 then emits a vibrating wave of frequency 20 Hz. This vibrating wave produces tactile stimulation in the ear of the user who, without waking the user, causes a movement that interrupts apnea apnea. It is thus possible, thanks to the invention, to minimize the duration of sleep apnea.

Note that station 3 can be programmed to record different signals obtained while the user is asleep. The programming of the station 3 can be carried out through the man-machine interface means 31 of the station or through the computer 5. The recorded signals will include the heart rate signal and the respiratory rate signal RR obtained from of the measurement carried out by the pressure sensor 200, as well as various other physiological signals, and the like, which can be measured by other sensors, indicated above, present in the end piece 20 of the atrium 2i, 22. The recordings made by the station 3 will allow an analysis of the signals whose waveforms can be displayed superimposed on the screen 310 of the station or on that of the computer 5. It is thus possible thanks to the invention to proceed to a self-assessment of the quality of his sleep and to detect possible apnea.

Of course, the invention is not limited to the embodiments which have been described more particularly here by way of example. Those skilled in the art, depending on the applications of the invention, may make various modifications and variants which fall within the scope of the appended claims.

Claims (10)

1. A device for detecting and treating sleep apnea in a person, comprising at least one intra-auricular auricle (2i, 22) having a pressure sensor (200) and a vibrator (21), capable of being placed in said ear canal (40), and a station (3) to which said in-ear headset (2i, 22) is connected, said device (1) comprising means distributed between said in-ear headset (2i, 22 ) and said station (3) for obtaining a respiratory rate signal (RR) from a blood pressure signal (PA) delivered by said pressure sensor (200), detecting sleep apnea (AP) from said respiratory rate signal (RR) and activate said vibrator (21) when said apnea (AP) is detected. 2. Device according to claim 1, characterized in that said vibrator (21) emits a vibration at an infrasonic frequency. 3. Device according to claim 1 or 2, characterized in that said in-ear headset (2i, 22) and said station (3) are connected by a bidirectional wireless communication link (L23i, L232). 4. Device according to claim 3, characterized in that said bidirectional wireless communication link (L23i, L232) is a radio communication link. 5. In-ear headset able to be included in a device (1) according to claim 4, characterized in that it comprises a nozzle (20) housing at least one sensor in the form of a pressure sensor (200) and a housing (26) containing a vibrator (21), an electronic circuit (23), a wireless transceiver (24) for communication with the station and a power source (25). 6. In-ear headset according to claim 5, characterized in that it also comprises an acoustic transmitter (22). 7. In-ear headset according to claim 5 or 6, characterized in that said electrical power source (25) comprises induction charging means. 8. Station able to be included in a device according to claim 3 or 4, characterized in that it comprises an electronic control unit (30), a radio transmitter-receiver (32) for communication with the intra-auricular auricle (2i , 22), man-machine communication means (31), a communication interface (33, 34) with a computer (5) and a power supply unit (35), said electronic control unit (30) comprising a software module (300) for processing in real time a blood pressure (PA) signal delivered by the pressure sensor (300) of the atrial atrium (2i, 22) and obtaining a respiratory rate signal (RR) from signal 5 of blood pressure (PA), detect sleep apnea (AP) from said respiratory rate signal (RR) and activate the vibrator (21) of the atrial atrium (2i, 22) when apnea (AP) is detected. 9. Station according to claim 8, characterized in that said electronic control unit (30) comprises data storage means for recording 10 of the signals read during the person's sleep and of the means of analysis (300) of said signals, and said man-machine interface means (31) include a display screen (310) intended to display said read signals. 10. Station according to claim 8 or 9, characterized in that said electrical supply unit (35) comprises induction charging means (352). 1/2