Miniaturized ear-wearing polysomnosis respiration monitoring device

Abstract

The invention discloses a miniaturized ear-wearing polysomnosis monitoring device which comprises at least one main body (2) suitable for being worn on the ear, the main body comprises a shell, and a control unit (3) used for collecting, storing and processing various physiological data, an audio sensor (5) used for collecting audio signals and a blood oxygen sensor (6) used for collecting blood oxygen signals are arranged in the shell. And the multi-axis acceleration sensor (8) is used for acquiring body position information. The sound pressure gain effect and the bone conduction characteristic of the outer ear are innovatively utilized to effectively improve the audio signal gain, the sensitivity and reliability of snore and airflow sound detection can be effectively improved, and hypopnea and apnea parameters are obtained; the blood oxygen sensor (6) is adopted to obtain parameters such as blood oxygen saturation and heart rate; and a multi-axis acceleration sensor (8) is adopted to acquire body position information. According to the invention, parameters such as snore, mouth-nose airflow, oxyhemoglobin saturation, heart rate, body position and the like can be simply, conveniently and effectively collected, and more OSAHS patients can enjoy convenient clinical diagnosis service.

Description

Technical Field

[0001] The invention relates to a polysomnography monitoring device, in particular to a miniaturized ear-worn polysomnography monitoring device. Background Art

[0002] Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common disease that has a significant impact on human health. Its clinical manifestations are complex, with snoring, apnea during sleep, and excessive daytime sleepiness as the main manifestations. When patients sleep, the pharynx partially or completely collapses, leading to repeated nocturnal sleep structure disorders, pathological sleep interruptions, and sleep hypoxemia. Patients are prone to fatigue and sleepiness during the day, which can induce work-related injuries, traffic accidents, and other accidents. In addition, OSAHS can also lead to a series of pathological changes in the body, causing chronic major diseases such as cerebrovascular disease, ischemic heart disease, hypertension, diabetes, arrhythmia, pulmonary hypertension, etc., which seriously endanger human health and safety.

[0003] At present, the gold standard for clinical diagnosis of OSAHS is polysomnography (PSG). PSG equipment generally uses various sensors to collect and record various physiological parameters, including snoring, oral and nasal airflow, blood oxygen saturation, body position, electroencephalogram, respiratory movement, electrooculogram, electromyogram, electrocardiogram, etc. These parameters are finally displayed in the form of curves, numbers, images, and audio and video to form information data that can be interpreted and analyzed, namely polysomnogram. Among them, snoring, oral and nasal airflow, and blood oxygen saturation are the most important parameters, which are used to determine whether there is hypoventilation and apnea, and give the hypopnea index (AHI) as an important basis for the clinical diagnosis of OSAHS. EEG helps to determine the sleep cycle and analyze the sleep structure. The current PSG equipment is complex in structure and expensive, and is only used in a few large hospitals. PSG equipment also uses a large number of dispersed sensors, which require a large number of wires to connect to the host, resulting in the patient's body being covered with wires, affecting comfort and disturbing the patient's sleep. In addition, most of these sensors are contact-type, which are complex to install, time-consuming and labor-intensive. These factors have severely limited the clinical popularity of PSG equipment, resulting in most OSAHS patients not receiving timely and effective diagnosis and treatment. Summary of the invention

[0004] The outer ear includes the auricle and the external auditory canal, and is an important auditory organ. During the long process of evolution, the outer ear has acquired excellent acoustic properties, which can efficiently collect and converge sound waves and transmit them to the eardrum. First, the outer ear has a resonance characteristic, which can produce a "sound pressure gain effect" by converging and reflecting sound waves. This gain effect covers the sound of 2000-7000Hz, which corresponds to the most important frequency range for human language perception. The main acoustic parameters collected by PSG, snoring and airflow sound, are within its gain range. Therefore, using ear-worn devices can more easily collect the snoring and airflow sound parameters of OSAHS patients than external devices; second, the outer ear also has a "bone conduction" characteristic, which can transmit sound waves directly to the cochlea through the bone structure to produce hearing. The snoring and airflow sounds of OSAHS patients can also be directly transmitted to the ear-worn device through bone conduction, which can further improve the sensitivity and reliability of the ear-worn device in detecting snoring and airflow sounds. The ear-worn device can also conveniently set an ear clip-type blood oxygen sensor on the auricle. In addition, the auricle is close to the temporal lobe of the brain, making it easy to set up electrodes to collect temporal EEG signals.

[0005] The purpose of the embodiment of the present invention is to provide a miniaturized ear-worn polysomnography device (miniaturized ear-worn PSG device), comprising at least one body suitable for ear-wearing and a sensor for collecting signals, wherein the body comprises a housing, and a control unit is arranged inside the housing for collecting and storing various physiological data and performing data processing;

[0006] The sensors that collect signals include:

[0007] Audio sensor: arranged in the housing and corresponding to the position of the external ear resonance cavity, connected to the control unit, and used for collecting audio signals;

[0008] Blood oxygen sensor: arranged in the housing, connected to the control unit, and collecting blood oxygen signals;

[0009] Multi-axis acceleration sensor: arranged in the housing, connected to the control unit, and used to obtain body position information.

[0010] The sensor of the present invention further comprises:

[0011] EEG sensor: connected to the control unit, used to be placed at the base of the ear tip above the auricle to obtain temporal EEG signals. The EEG sensor can be independently set outside the main body and connected to the control unit inside the main body through a wire; if the main body is provided with an ear hook, it is set on the ear hook.

[0012] In the present invention, a power supply and power management unit is also arranged inside the shell of the main body, which provides a stable power supply required for at least one whole night of sleep breathing monitoring and can be charged and used repeatedly.

[0013] The control unit can transmit data to a workstation computer through a wireless or wired interface circuit system for detailed analysis and processing, thereby achieving accurate diagnosis of OSAHS.

[0014] The blood oxygen sensor adopts a transmission type blood oxygen sensor or a reflection type blood oxygen sensor, which can be close to the auricle.

[0015] Preferably, the main body of the miniaturized ear-worn polysomnography monitoring device is configured as a closed ear-worn shell structure, which may be an in-ear structure, an ear-pressing structure, or an ear-covering structure, which can effectively isolate peripheral noise, improve signal gain, and play a good fixing role. The closed ear-worn shell structure can more effectively closely contact the auricle and its surrounding structures to form a closed resonance cavity, and closely contact the auricle and its surrounding structures to form bone conduction.

[0016] When the main body is an ear-pressing structure or an ear-covering structure, the main body is provided with an ear pad, the audio sensor and the blood oxygen sensor are arranged in the shell, and the electroencephalogram sensor is arranged at a position of the ear pad corresponding to the root of the ear tip above the auricle.

[0017] Preferably, the power supply and power management unit includes a lithium battery pack and a power management module for controlling the operation of the lithium battery pack, providing a stable power supply required for at least one full night of sleep breathing monitoring. The power supply and power management unit is provided with a charging interface to charge the lithium battery pack, and the interface can be set as a dedicated magnetic suction interface or a universal USB interface.

[0018] The miniaturized ear-worn PSG device provided by the present invention has the following beneficial effects:

[0019] 1. The outer ear has good resonance characteristics in the audio range of 2000-7000Hz, covering the audio range of snoring and airflow sounds, and can produce a sound pressure gain effect; at the same time, snoring and airflow sounds can also be directly transmitted through bone conduction, further improving the sensitivity and reliability of acoustic detection. The miniaturized ear-worn PSG device of the present invention innovatively utilizes the sound pressure gain effect and bone conduction characteristics of the outer ear to effectively improve the gain of the audio signal, and can effectively improve the sensitivity and reliability of detecting snoring and airflow sounds. By analyzing the interruption time of snoring and airflow sounds, the parameters of the number and duration of apnea can be obtained, and hypopnea and apnea parameters can be obtained. Hypopnea parameters can be obtained by analyzing the changes in the acoustic characteristics of snoring and airflow sounds and combining them with blood oxygen saturation parameters.

[0020] 2. The inner cavity of the main body of the present invention is connected to the external auditory canal, and a resonance cavity is formed after sealing, which can produce three advantages:

[0021] (1) After resonance, the gain is significantly increased, and the audio detection sensitivity is improved;

[0022] (2) Bone conduction is formed, and the airflow sound and snoring sound are directly transmitted through the contact between the body and the external auditory canal. The efficiency is significantly higher than that through air transmission, further improving the gain.

[0023] (3) After being sealed, it can effectively isolate external noise and significantly improve the signal-to-noise ratio.

[0024] 3. The present invention uses a blood oxygen sensor to obtain parameters such as blood oxygen saturation and heart rate; uses an EEG sensor at the base of the ear tip to obtain temporal EEG signals; and uses a multi-axis acceleration sensor to obtain body position information. The miniaturized ear-worn PSG device can simply, conveniently and effectively collect parameters such as snoring, oral and nasal airflow, blood oxygen saturation, heart rate, EEG, body position, etc., aiming to allow more OSAHS patients to enjoy convenient clinical diagnosis services.

[0025] 4. The present invention adopts ultra-lightweight and miniaturized design, effectively improving system reliability and reducing costs, solving the problems of complex structure, low reliability and high cost of current PSG devices.

[0026] 5. The present invention significantly improves operability through integrated, wire-free design, saves time and effort, and solves the problem of complicated wire connection and cumbersome operation of current PSG equipment. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 Schematic diagram of the structure of the miniaturized ear-worn PSG device described in Example 1.

[0028] Figure 2 3D diagram of the main body of the miniaturized ear-worn PSG device according to the first embodiment.

[0029] Figure 3 2. It is a front view of the miniaturized ear-worn PSG device described in Example 2. Specific embodiments

[0030] Embodiment 1

[0031] The miniaturized ear-worn polysomnography monitoring device is an in-ear structure, comprising a main body 2 suitable for being worn on the ear, and a sensor for collecting signals. Figure 1-2 It is a structural schematic diagram showing the position relationship between the main body 2 and the sensor for collecting signals.

[0032] The main body 2 is a closed ear-wearing shell structure. One end of the ear canal is embedded with a detachable earplug 21, which is used to adapt to the external auditory canal and fix the entire device when worn. The other end is located in the auricle, which is enlarged and has an inner cavity. The earplug 21 is made of silicone material, has a longitudinal channel, and is connected to the inner cavity of the main body 2. A control unit 3 is set in the inner cavity for collecting, storing various physiological data, and performing data processing. The data can be transmitted to a workstation computer for detailed analysis and processing through a wireless or wired interface circuit system to achieve accurate diagnosis of OSAHS. The inner cavity of the shell of the main body 2 is also provided with a power supply and power management unit 4 to provide a stable power supply required for at least one night of sleep breathing monitoring. The power supply and power management unit includes a lithium battery pack and a power management module for controlling the operation of the lithium battery pack, providing a stable power supply required for at least one night of sleep breathing monitoring, and can be charged and used repeatedly. The power supply and power management unit is provided with a charging interface to charge the lithium battery pack, and the interface can be set to a dedicated magnetic suction interface or a universal USB interface.

[0033] The sensors that collect signals include:

[0034] Audio sensor 5: connected to the control unit. It is arranged in the inner cavity of the main body 2 and corresponds to the position of the outer ear resonance cavity of the auricle 1. The outer shell of the main body 2 is provided with a through hole so that the inner cavity communicates with the outer ear resonance cavity, so that the audio sensor 5 in the inner cavity of the main body 2 can collect snoring and airflow sounds. The outer ear has good resonance characteristics in the audio range of 2000-7000Hz, covering the audio range of snoring and airflow sounds, and can produce a sound pressure gain effect; at the same time, snoring and airflow sounds can also be directly transmitted through bone conduction, further improving the sensitivity and reliability of acoustic detection. Therefore, the audio sensor 5 is located in the outer ear resonance cavity, which can effectively collect snoring and airflow sounds, transmit them to the control unit, and transmit them to the processor. The processor analyzes the interruption time of snoring and airflow sounds to obtain the parameters of the number and duration of apnea, analyzes the changes in the acoustic characteristics of snoring and airflow sounds, and combines them with blood oxygen saturation parameters to obtain hypopnea parameters. -

[0035] Blood oxygen sensor 6: The main body 2 is located at one end of the outer side of the ear canal and has a mounting hole facing the outer wall of the auricle. The blood oxygen sensor 6 is embedded in the mounting hole and is used to contact the skin of the auricle 1 to collect blood oxygen signals. The blood oxygen sensor 6 is a reflective blood oxygen sensor, which consists of a light-emitting diode 61 with two wavelengths and a phototransistor 62. The light-emitting diode 61 emits red light and infrared light to penetrate the skin tissue and irradiate the hemoglobin in the capillaries. The phototransistor 62 receives the reflected or transmitted light. By measuring the changes in the intensity of the two lights reflected or transmitted after penetrating the skin, the ratio of oxygenated hemoglobin to total hemoglobin in the blood, that is, blood oxygen saturation (SpO2), can be calculated. Heart rate parameters can also be obtained at the same time.

[0036] The electroencephalogram sensor 7 is connected to the control unit 3 in the main body 2 through a wire. When in use, the electroencephalogram sensor 7 is set at the position of the tip of the ear above the auricle to obtain the temporal electroencephalogram signal.

[0037] Multi-axis acceleration sensor 8: arranged in the main body 2, connected to the control unit 3, and used to obtain body position information.

[0038] Embodiment 2

[0039] Different from the first embodiment, Figure 2 As shown, the main body 2 is provided with an ear hook 22, and the EEG sensor 7 is arranged on the ear hook 22 at a position corresponding to the base of the ear tip above the auricle. After being worn, the ear hook 22 contacts the base of the ear tip above the auricle to obtain temporal EEG signals.

[0040] In more embodiments, the main body 2 of the present invention can also be set as an ear-pressing structure or an ear-covering structure. In these two structures, the main body 2 is provided with an ear pad, the audio sensor 5, the blood oxygen sensor 6 and the multi-axis acceleration sensor 8 are arranged in the shell, and the electroencephalogram sensor 7 is arranged at the position of the ear pad corresponding to the root of the ear tip above the auricle.

Claims

1. A miniaturized ear-worn polysomnography monitoring device, characterized in that: The device comprises at least one main body (2) suitable for being worn on the ear, and a sensor for collecting signals, wherein the main body (2) comprises a housing, and a control unit (3) is arranged inside the housing for collecting and storing various physiological data and performing data processing; The sensor for collecting signals includes: An audio sensor (5): arranged in the housing and corresponding to the position of the external ear resonance cavity, connected to the control unit (3), and used for collecting audio signals; A blood oxygen sensor (6) is disposed in the housing, connected to the control unit (3), and collects blood oxygen signals; A multi-axis acceleration sensor (8) is arranged in the housing and connected to the control unit to obtain body position information.

2. The miniaturized ear-worn polysomnography device according to claim 1, characterized in that: The blood oxygen sensor (6) is a transmission type blood oxygen sensor or a reflection type blood oxygen sensor.

3. The miniaturized ear-worn polysomnography device according to claim 1, characterized in that: The main body (2) is configured as a closed ear-worn shell structure.

4. The miniaturized ear-worn polysomnography device according to claim 3 is characterized in that: The closed earband shell structure is an in-ear structure, an ear-pressing structure or a circum-ear structure.

5. The miniaturized ear-worn polysomnography device according to claim 4 is characterized in that: When the main body (2) is an ear-pressing structure or an ear-covering structure, the main body (2) is provided with an ear pad, and the audio sensor (5), the blood oxygen sensor (6) and the multi-axis acceleration sensor (8) are arranged in the housing.

6. The miniaturized ear-worn polysomnography device according to claim 4, characterized in that: The main body (2) is an in-ear structure and is provided with an ear hook.

7. The miniaturized ear-worn polysomnography device according to any one of claims 1 to 6, characterized in that: The sensor also includes: The electroencephalogram sensor (7) is connected to the control unit and is used to be placed at the base of the ear tip above the auricle to obtain the temporal electroencephalogram signal.

8. The miniaturized ear-worn polysomnography device according to claim 7, characterized in that: When the main body (2) is an ear-pressing structure or an ear-covering structure, the electroencephalogram sensor (7) is arranged at a position of the ear pad corresponding to the base of the ear tip above the auricle; when the main body (2) is an ear-in structure and is provided with an ear hook, the electroencephalogram sensor (7) is arranged at a position of the ear hook (22) corresponding to the base of the ear tip above the auricle.

9. The miniaturized ear-worn polysomnography device according to claim 1, characterized in that: A power supply and power management unit is also arranged in the shell of the main body (2).

10. The miniaturized ear-worn polysomnography device according to claim 9, characterized in that: The power supply and power management unit includes a lithium battery pack and a power management module for controlling the operation of the lithium battery pack.

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