CN214104390U - Miniature ear-worn physiological device - Google Patents

Abstract

The present invention relates to a micro ear-worn physiological device, in a preferred embodiment, the micro ear-worn physiological device comprises a housing and an in-ear maintaining structure for disposing the housing in an auricle of a user, wherein the in-ear maintaining structure comprises a set of parts and a propping part, the set of parts is combined with at least a part of the housing, and the housing is disposed toward the bottom of the concha cavity of the auricle with the lower housing, the propping part is configured to extend from the set of parts to prop against the tragus of the auricle, so that the housing is maintained to be disposed in the concha cavity, and between the set of parts and the tragus, at least one channel is configured to be formed for sound to pass through, thereby achieving the effect of not affecting the hearing of the user.

Description

Miniature ear-worn physiological device

Technical Field

The present invention relates to a miniature ear physiological device, and more particularly, to a miniature ear physiological device which has a small size and can be installed at the ear.

Background

Wearable physiological apparatuses have become more popular with the development of technology, such as wrist-worn physiological apparatuses, and are more integrated into the daily lives of general people, for example, many people wear wrist-worn physiological apparatuses in daily lives to record daily activities and measure simple physiological information, such as heart rate.

With the modern people paying more and more attention to the physiological condition of the modern people, the requirement on the physiological detection function provided by the wearable physiological device is higher and higher, and the physiological detection function is not satisfied with single and simple physiological information any more; meanwhile, modern people have higher requirements on the appearance and the volume of the wearable physiological apparatus, and expect to achieve the effects of lightness and wearing no sense besides the appearance.

Therefore, it is an important issue how to break through the limitations of the conventional wearable physiological apparatuses and meet the needs of modern people.

SUMMERY OF THE UTILITY MODEL

This implement novel aim at provides a miniature ear-worn physiological device, includes: a shell at least comprising an upper shell and a lower shell; a control unit, which is contained in the shell and at least comprises a microcontroller/microprocessor; a light sensor electrically connected to the control unit and including at least one light source and at least one light detector; a communication module electrically connected to the control unit; a battery; and an in-ear retention structure, wherein the housing is disposed within an auricle of a user via the in-ear retention structure; and the in-ear maintenance structure comprises a set of parts and a propping part, wherein: the engaging member is configured to engage at least a portion of the housing and to position the housing with the lower housing facing a bottom of the concha cavity of the auricle; and the abutting part is constructed to extend out from the sheathing part so as to abut against the tragus of the auricle, so that the shell is maintained to be arranged at the concha cavity, and when the shell is arranged at the concha cavity, the at least one light-emitting source emits at least one light ray to enter tissues below the bottom of the concha cavity, and the at least one light ray is received by the at least one light detector after being reflected by blood in blood vessels, so that blood physiological information of the user is obtained; and at least one channel is formed between the set of parts and the tragus for sound to pass through, thereby achieving the effect of not influencing the hearing of the user.

Another object of the present invention is to provide a miniature ear-worn physiological apparatus, comprising: a shell at least comprising an upper shell and a lower shell; a circuit board, which is accommodated in the shell and is provided with an upper surface and a lower surface, wherein the lower surface faces the lower shell; a battery arranged above the circuit board; at least one magnetic substance; and a magnetic attraction structure for arranging the housing on an auricle part of a user, wherein the circuit board is at least provided with: a control unit at least comprising a microcontroller/microprocessor; at least one physiological sensing element electrically connected to the control unit; and a communication module electrically connected to the control unit, wherein the magnetic attraction structure comprises: a housing part for combining with at least one part of the shell; a magnetic member; and a connection member for connecting the receiving member and the magnetic member, and wherein the housing and the receiving member are constructed to be located at one side of the auricle part and the magnetic member is constructed to be located at the other side of the auricle part by a deformation characteristic of the connection member, and the housing is fixed to the auricle part by a magnetic attraction between the magnetic member and the at least one magnetic substance; and the control unit acquires at least one piece of physiological information from the auricle part through the at least one physiological sensing element.

Another object of the present invention is to provide a miniature ear-worn physiological apparatus, comprising: a shell at least comprising an upper shell and a lower shell; a control unit at least comprising a microcontroller/microprocessor; at least one physiological sensing element electrically connected to the control unit; a communication module electrically connected to the control unit; a battery; an auricle front part disposed at a auricle front side of an auricle of a user; and a connecting structure for connecting the housing and the ear front part, wherein the connecting structure has an ear front part and an ear rear part, wherein the ear front part has a first connecting member for mechanically connecting with at least a part of the ear front part, and the ear rear part has a second connecting member for mechanically connecting with at least a part of the housing, and the ear front part and the ear rear part generate a relative force; the ear front part is fixed by mutually clamping with the physiological structure at the front side of the auricle, so that the ear front part of the connecting structure is fixed, and then the shell is fixed at the back side of the auricle by the relative force application between the ear front part and the ear back part; and the control unit acquires at least one piece of physiological information of the user through the at least one physiological sensing element.

Drawings

The accompanying drawings are included to provide a better understanding of the present invention and are not intended to constitute an undue limitation on the invention. Wherein:

FIG. 1 is an exploded view of a micro-physiological apparatus according to a preferred embodiment of the present invention;

FIG. 2 is a schematic circuit diagram of a micro physiological apparatus according to the present invention;

FIGS. 3A-3G are schematic views illustrating possible combinations of the housing and the adhesive structure of the present invention;

FIG. 4 is a schematic view of a protruding structure of the lower housing of the present invention;

FIGS. 5A-5B are schematic diagrams illustrating electrical extension mount structures;

FIG. 6 is a schematic view showing the combination of the electrophysiological input/output device of the present invention with the fastener and the button electrode;

fig. 7 is a schematic view of an electrical extension base structure mounted on the forehead in accordance with a preferred embodiment of the present invention;

FIG. 8 is a schematic view of an electrical extension base structure implemented in a neck-worn form in accordance with a preferred embodiment of the present invention;

FIG. 9 is a schematic view of an electrophysiological input/output element implemented as a respiratory airflow sensor and located in the oronasal region according to a preferred embodiment of the present invention;

FIG. 10 is a schematic view of the combination of an electrically extended base structure and a housing with a protrusion structure according to a preferred embodiment of the present invention;

FIG. 11 is a schematic view of the combination of the housing and the insulating layer according to a preferred embodiment of the present invention;

fig. 12 is a schematic diagram of a charging/communication base structure according to a preferred embodiment of the present invention;

fig. 13 is a schematic view of an electrical contact member implemented as a header connector in accordance with a preferred embodiment of the present invention;

FIG. 14 is a schematic diagram showing the relative positions of auricles and cerebral cortex in the skull according to the present invention;

FIG. 15 is a schematic view of the front physiological structure of the auricle of the present invention;

FIGS. 16A-16D are schematic diagrams illustrating possible implementations of an in-ear maintenance structure of the present invention;

FIGS. 17A-17B are schematic views of the magnetic attraction structure of the present invention; and

fig. 18A-18C show schematic views of possible implementations of the ear front part and the connection structure of the present invention.

Description of the symbols in the drawings

100 housing 102 magnetic substance

101. 503 electric contact part 12 upper shell

14 battery 16 circuit board

161 block circuit board 18 lower case

181 projection structure 20 optical sensor

30 attach structure 301 accommodation space

302 lip 31 adhered substance

32-adhesive 50 electrical extension base structure

501 main housing 502 extension

504 electrophysiological input/output element 5041 Electrical contact pad

601. 602 binder 603 button electrode

70 load bearing structure 80 neck wear structure

801 neck fixture 802 torso contact body

803 the electrophysiological signal extraction electrode 804 is electrically connected to the propping member

901 respiratory airflow sensor 110 barrier

120 charging/communication base structure 1201 charging/communication electrical contact part

1202 communication interface 1203 opening

130 spike connector 150 ear canal

151 tragus 152 intertragic notch

153 antitragus 154 concha cavity

155 concha wall 156 concha boat

157 helix 158 antihelix crus

160 in-ear maintenance structure

161 cover part 162 abutting part

163 channel 170 magnetic attraction structure

171 accommodating member 172 connecting member

173 magnetic force component 180 ear front parts

181 in-the-ear part 182 extension rod

190 connecting structure 191 first combination

192 second coupling member 193 magnetic member

Detailed Description

Exemplary embodiments of the invention are described below with reference to the accompanying drawings, in which various details of embodiments of the invention are included to assist understanding, and which are to be considered exemplary only. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

The utility model discloses the application is for making the volume of physiology device miniaturized, what the device was inside to be adopted is range upon range of structural design, as shown in fig. 1, casing 100 is constructed for from top to bottom range upon range of setting up last casing 12, battery 14, circuit board 16, and lower casing 18, and the bottom surface of casing is planned and is used for towards human skin down, wherein, this circuit board 16 has an upper surface and a lower surface, physiology sensing element is set up on this circuit board, and battery 14 is maintained in circuit board 16 top, through such setting, inside circuit connection configuration can be the simplest, in order to provide the biggest battery volume, and then reach in small and exquisite volume, also possess sufficient electric power.

Since the volume of the battery is one of the main factors determining the volume of the device, it is possible to select a rechargeable battery, such as a lithium battery, or a disposable non-rechargeable battery, in consideration of whether the volume can conform to the body curve of the desired location, and also in consideration of whether the power is sufficient to provide the usage requirement of the location.

In addition, an electrical contact component may be disposed on the surface of the housing, as shown in the figure, one end of the electrical contact component 101 is mounted on the circuit board, and the other end is exposed out of the bottom surface of the lower housing to form a position where power can be supplied and contacted, so as to perform charging, communication, or other electrical connection, for example, the electrical contact component may be used to charge a rechargeable battery, perform wired communication between the physiological apparatus and the outside, for example, transmit information, perform setting, and the like, and also perform electrical extension of the physiological sensing element.

Such hardware configuration and electrical connection design make the device housing present a column-like appearance, such as a column with the same or different width/diameter, and the cross section of the column can be various shapes, such as circular, square-circular, etc., or different shapes, which can be changed according to the actual requirement, all belonging to the scope claimed by the present invention.

It should be noted that, in addition to the upper housing and the lower housing, the housing may also be implemented to include other housing parts according to different practical requirements, for example, an additional middle housing is disposed between the upper housing and the lower housing, so that it is feasible without limitation.

Next, please refer to fig. 2, which illustrates a schematic circuit diagram of a physiological apparatus according to the present application. When used for physiological signal acquisition, it is known to have a control unit in addition to the physiological sensing element and the battery to control the operation of the overall device, the control unit including at least one microcontroller/microprocessor preloaded with programs to handle communication between hardware elements, the control unit enabling signal transmission between different hardware elements and external applications/devices connected to the device, and also to allow the behavior of the device to be programmed to respond to different operating conditions, and the microcontroller/microprocessor also using an internal timer (not shown) to generate time stamps or to control the operation.

In addition, the control unit often includes an Analog Front End (AFE) circuit for performing, for example, analog-to-digital conversion, amplification, filtering, and other various signal processing procedures known to those skilled in the art, which are conventional and therefore not described in detail herein.

In addition, the device may include a communication module, which may be implemented as a wired communication module, such as a USB interface, a UART interface, etc., or a wireless communication module, such as Bluetooth (Bluetooth), Low Energy Bluetooth (BLE), Zigbee, WiFi, or other communication protocols, for communicating with an external device, wherein the external device may include, but is not limited to, a smart device, such as a smart phone, a smart bracelet, smart glasses, a smart headset, etc., a tablet computer, a notebook computer, a personal computer, and the communication enables information to be exchanged between the devices, and also enables operations such as information feedback, remote control, and monitoring, etc.

Alternatively, when a rechargeable battery is used, the device may have a charging module, such as an inductive charging circuit, or be charged via, for example, a USB interface.

In addition, the device may include an information providing interface, preferably an LCD or LED display element, to provide information to the user, such as, without limitation, physiological information, statistical information, analysis results, stored events, operating modes, alert content, progress, battery status, etc.

Furthermore, the device may include a data storage unit, preferably a memory, such as an internal flash memory, or a removable memory disk, for storing the acquired physiological information.

In addition, when having a wireless communication module, the antenna is correspondingly configured, and in order to place the antenna with a certain length into a tiny casing, the antenna can be arranged around the casing, for example, the antenna can be arranged along the edge of a circuit board in a printed circuit form, or the antenna can be combined on the casing, for example, attached to the inner side or the outer side of the casing, or embedded in the wall of the casing, or a separate wire body can be used as the antenna to be distributed along the inner surface of the casing, which is also a way of providing the antenna with a sufficient length; alternatively, a Chip Antenna (Chip Antenna) may be used without limitation.

Next, a description of the physiological sensing element is provided. One option is a light sensor, which is a sensor having both a light source, such as an LED, and a light detector, such as a photodiode (photodiode), and utilizes the principle of PPG (photoplethysmography), wherein light emitted from the light source enters human tissue, is received by the light detector after penetrating blood in a blood vessel or after being reflected by the blood, and obtains blood physiological information by obtaining the volume change of the light, which is also generally referred to as PPG signal; since the optical sensor obtains physiological information from blood, the position of the optical sensor can be any body surface area with blood vessels distribution, no matter the head, the front or the back of the body, the limbs, etc., are all feasible without limitation.

Wherein the PPG signal comprises a fast moving Component (AC Component), which reflects the pulse wave generated by the contraction of the myocardium propagating through the artery, and a slow moving Component (DC Component), which reflects the slower changes in tissue blood volume, such as Respiratory Effort (i.e., the dilatory action of the thoracico-abdominal region during respiration), the effects of sympathetic and parasympathetic activity, and the meier Waves (Mayer Waves); in addition, physiological information such as related blood vessel hardness and blood pressure can be obtained by analyzing the PPG signal; furthermore, physiological experiments show that the PPG pulse can generate harmonic resonance between each viscera and heart rate after frequency domain analysis, so that the pulse wave and heart rate harmonic resonance distribution can be applied to diagnosis of traditional Chinese medicine and monitoring of blood circulation of human body, for example, the liver and liver channels are related to the first harmonic of heart rate, the kidney and kidney channels are related to the second harmonic of heart rate, the spleen and spleen channels are related to the third harmonic of heart rate, the lung and lung channels are related to the fourth harmonic of heart rate, and the stomach and stomach channels are related to the fifth harmonic of heart rate.

Generally, the blood physiological information obtained may vary according to the type and number of the light sources and the light detectors included in the light sensor, for example, the light sensor may include at least one light source, such as an LED or a plurality of LEDs, preferably infrared light, red light, green light, blue light, or white light composed of multiple wavelength light sources, and at least one light detector to obtain the pulse rate/heart rate, and other blood physiological information, such as respiration physiological information, wherein the green light and other visible light, such as blue light or white light, are the main light sources currently used for measuring the heart rate, and mainly focus on the interpretation of the AC component part when measuring the pulse rate/heart rate; the effect of respiration on blood is that as a person breathes, the pressure within the chest cavity (the so-called intrathoracic pressure) changes with each breath, wherein during inspiration the chest expands causing a decrease in intrathoracic pressure, which draws air into the lungs, and during expiration the intrathoracic pressure increases forcing air out of the lungs, and these changes also cause a change in the amount of blood returning to the heart via the veins and the amount of blood driven into the arteries by the heart, which can be detected by analyzing the DC component of the PPG signal, referred to herein as low frequency respiration; furthermore, since the heart rate is controlled by the autonomic nerve, respiration affects the autonomic nervous system to cause a change in the heart beat, so-called Sinus Arrhythmia (RSA), which is generally accelerated during inspiration and slowed during expiration, so that the change in respiration can also be known by observing the heart rate, herein referred to as RSA respiration; therefore, the physiological information of respiration obtained by the optical sensor is collectively called respiration behavior.

The obtained Heart Rate may be further analyzed to obtain other related physiological information, such as calculating the Heart Rate Variability (HRV) to know the activity of the autonomic nerve, analyzing whether there is suspected arrhythmia, etc.

Alternatively, the light sensor may comprise at least two light sources, such as a plurality of LEDs, preferably green, infrared and/or red light, and at least one light detector for obtaining blood oxygen concentration (SPO2), pulse rate/heart rate and other physiological information of the blood, wherein, when measuring blood oxygen concentration, two different wavelengths of light are required to be irradiated into the tissue, and the two wavelengths of light are absorbed differently by the oxyhemoglobin (HbO2) and the non-oxyhemoglobin (Hb) in the blood, and after receiving the light that has been transmitted and reflected, the result of comparing the two can determine the blood oxygen concentration, therefore, the measurement of blood oxygen concentration is usually more limited for the position where the light sensor is installed, preferably the position where the light can be actually irradiated into the artery, such as the finger, palm, inner face, toe, sole, etc., and especially the toe/sole is often used when measuring the blood oxygen concentration of infants, the two different wavelengths may be, for example, red light and infrared light, or green light with two wavelengths, such as 560nm and 577nm, respectively, so that the light source can be selected according to the requirement without limitation.

The wavelength ranges of the above-mentioned light sources are, for example, the red light wavelength is about 620nm to 750nm, the infrared light wavelength is about more than 750nm, and the green light wavelength is about 495nm to 580nm, and for measurement, the red light wavelength is usually 660nm, the infrared light wavelength is 895nm, 880nm, 905nm or 940nm, and the green light wavelength is about 510 nm to 560nm or 577nm, however, it should be noted that, in practical use, other wavelengths of light sources can be used according to different purposes, for example, when only the heart rate is to be obtained, as mentioned above, blue light or white light composed of multiple wavelength light sources is also suitable to be selected, and therefore, for more precise description, the "wavelength combination" is used instead of the "wavelength" in the following description to cover the possibility of using multiple wavelength light sources.

In addition, particularly, the light sources can have three wavelength combinations at the same time, for example, in one embodiment, the first light source is implemented as an infrared light source to generate light with the first wavelength combination, the second light source is implemented as a red light source to generate light with the second wavelength combination, and the third light source is implemented as a green light source, a blue light source, or a white light source to generate light with the third wavelength combination, wherein the infrared light source and the red light source are used for obtaining blood oxygen concentration, and the green light source, the blue light source, or the white light source is used for obtaining heart rate; alternatively, in another embodiment, the light of the first wavelength combination is implemented as infrared light or red light, and the light of the second wavelength combination and the light of the third wavelength combination are implemented as green light, blue light, and/or white light, etc., wherein two of the wavelength combinations can be used to obtain the blood oxygen concentration, and the other wavelength combination can be used to obtain the heart rate; alternatively, in another embodiment, the light of the first wavelength combination, the light of the second wavelength combination, and the light of the third wavelength combination are all implemented as green light, wherein the green light of the two wavelength combinations can be used to obtain the blood oxygen concentration, and the green light of the other wavelength combination can be used to obtain the heart rate, and since, as shown above, different parts of the body can obtain different types of blood physiological information, the light source capable of generating multiple wavelength combinations is provided to achieve the purpose of obtaining various required blood physiological information by moving the same device to different parts of the body, for example, when the blood oxygen concentration is required to be obtained, the device is moved to a position where the light can be injected into an artery, and when the heart rate or other blood physiological information is required to be obtained, only the position of a blood vessel or a micro blood vessel is required. Therefore, there is no limitation.

It should be noted that, when there are three light-emitting sources, the number and the arrangement position of the light detectors can be varied according to the requirement. For example, two photodetectors may be implemented, wherein one photodetector with a single infrared light source and a single red light source is used to obtain blood oxygen concentration, and the other photodetector with a green light source implemented as two together obtains heart rate; alternatively, a single light detector and each of an infrared light source, a red light source, and a green light source may be used to obtain blood oxygen concentration and heart rate; alternatively, a single light detector may also obtain the blood oxygen concentration with a single red light source and a single infrared light source, and also obtain the heart rate with three green light sources, and therefore, there is no limitation.

In addition, in the selection of the photo detector, when detecting the blood oxygen concentration, since the environment contains other light sources, it is preferable that the photo detector receiving the infrared light is selected to have a smaller size to avoid saturation due to the ambient light; on the other hand, the photodetectors for receiving green light, blue light, white light, etc. may have a larger size to obtain effective reflected light, and may further adopt a process of blocking other light sources, for example, a filter material is adopted to isolate low-frequency infrared light in the environment to obtain a signal with a better S/N ratio.

Furthermore, when the heart rate is obtained, in order to eliminate noise, such as environmental noise, noise generated by body movement during wearing, etc., a plurality of light sources (and wavelengths are not limited, green light can be used, and light sources with other wavelengths can also be used) may be provided, and digital signal processing, such as calculation of Adaptive Filter (Adaptive Filter) or mutual subtraction, is performed on the PPG signals obtained by different light sources, so as to achieve the purpose of eliminating noise, and thus, there is no limitation.

In the present application, in order to minimize the volume and simplify the manufacturing process, particularly, on the premise that the micro-housing is composed of at least an upper housing and a lower housing, the material of the lower housing is a light-permeable material to save the space for disposing a light-permeable lens (lens) in the prior art, for example, the lower housing is made of a transparent material capable of transmitting visible light or a material capable of transmitting light emitted from other light sources, such as infrared rays, thereby achieving the effect of reducing the volume and saving the step of additionally disposing a light-permeable lens in the manufacturing aspect, the shell structure is that the upper shell and the lower shell are separated from each other, so the materials of the upper shell and the lower shell can be selected to be the same or different according to requirements without limitation, and more changes can be presented on the appearance through proper design. Of course, under the condition of suitable volume size, a common method for disposing the light sensor may also be adopted, for example, a transparent lens is disposed at a position of the lower housing corresponding to the light sensor, or a transparent material is filled around the light sensor, without limitation.

It should be noted that, in all the following embodiments, as long as the physiological information is obtained by the light sensor, the above-mentioned contents related to the housing made of the light-transmitting material and/or the contents related to the housing provided with the light-transmitting lens and the filling of the light-transmitting material are applied, and therefore, based on the principle of brief description, the following description will not be repeated.

Another physiological sensing device is an electrophysiological input/output device, for example, the electrode is one of the electrophysiological input/output devices, such as an electrophysiological signal acquisition electrode, an impedance detection electrode, and an electrical stimulation electrode.

Generally, the electrodes are divided into two types, Wet electrodes (Wet electrodes) and Dry electrodes (Dry electrodes), wherein the Wet electrodes are electrodes that need to be contacted with the skin of the human body by a conductive medium, for example, conductive paste, conductive glue, conductive liquid, etc. are commonly used as the conductive medium, most commonly, cup-shaped electrodes with conductive paste, and Electrode patches with conductive glue formed in advance are used; on the other hand, the dry electrode does not need a conductive medium, and may be implemented to obtain an electrical signal by directly contacting with the skin, or may be implemented in a non-contact manner, such as a capacitive electrode, an inductive electrode, or an electromagnetic electrode, and may be made of a variety of materials, for example, a conductive material known to sense a spontaneous potential difference of a human body may be used as the dry electrode, such as metal, conductive fiber, conductive rubber, conductive silicone, and the like. The electrodes usually disposed on the surface of the housing are usually in the form of dry electrodes to simplify the operation procedure.

The electrophysiological signal acquisition electrodes are mainly used for acquiring electrophysiological signals of a human body, such as electroencephalogram signals, electro-oculogram signals, electrocardio signals, myoelectricity signals, skin electric signals, and the like, and can be arranged in different body surface areas, such as a head area, a neck area (including front and back areas), a trunk area (including front and back areas), four limbs, and the like, according to the acquired electrophysiological signals; the potential change of the signal acquiring position is obtained by arranging at least two electrodes at the position, but since the shell of the present application has a small volume, and more preferably no more than one electrode is arranged on a single surface, it is preferable in practice that one electrode is arranged on the bottom surface and contacts the skin at the position, and the other electrode changes according to the type of the electrophysiological signal to be acquired, for example, the acquisition of the electrocardiographic signal can be achieved by arranging another electrode on a surface other than the bottom surface, for example, the top surface and the side surface, and contacting with a limb, for example, by hand, and the acquisition of other electrophysiological signals is preferably performed by extending another electrode from the shell to perform the acquisition of the electrophysiological signal together with the electrode on the shell, and the electrocardiographic signal can also be acquired in this way; the electrical skin signal is obtained by applying a tiny voltage or current source between two electrodes to obtain an impedance signal at the location, and detecting a skin potential difference signal between the two electrodes.

It should be noted that, in general, when acquiring electrophysiological signals, the usable electrodes include an electrophysiological signal acquisition electrode and a Right Leg Driver (DRL) electrode, wherein the signal acquisition electrode is used to acquire electrophysiological signals, the DRL electrode is used to eliminate common mode noises (e.g. 50Hz/60Hz power noise), and/or provide Body Potential Level (Body Potential Level) to match with the circuit reference Potential, and when in use, according to actual usage, a two-pole mode can be adopted, two electrophysiological signal acquisition electrodes are used to acquire electrophysiological signals, and the DRL electrode can be further used to adopt a three-pole mode, and the configuration can be flexibly changed without limitation.

The impedance detection electrodes are arranged on the trunk, such as the chest and the abdomen, to obtain the impedance signal of the human body, and the impedance change comes from the impedance change of muscle tissues caused by the fluctuation of the chest and/or the abdomen when the human body breathes, so the sleeping respiration condition can be known by analyzing the impedance change, for example, the existence of the respiration action, the size of the respiration amplitude, the respiration frequency and other respiration related information can be known.

Electrical Stimulation electrodes may be used to provide Electrical Stimulation to the body, with common Electrical stimulations including, for example, tCS (transcranial Current Stimulation), TENS (transcutaneous Electrical nerve Stimulation), MET (micro-Current Therapy), and other known Electrical stimulations, common forms of tCS include tDCS (transcranial Direct Current Stimulation), tACS (transcranial Alternating Current Stimulation), and tRNS (transcranial Random N oil Stimulation), wherein, the transcranial electrical stimulation is applied to local physiological tissues above the cerebral cortex so as to influence the activity of the corresponding cerebral cortex, the applied current is very weak, e.g., the applied current range is typically below 2 milliamps, and thus the subject typically does not have a noticeable sensation during the performance of the electrical stimulation; in addition, TE NS and MET are commonly used to alleviate symptoms of body parts, such as muscle soreness, and are widely used.

Another electrophysiological input/output device is a respiratory airflow sensor for acquiring respiratory airflow changes, such as a thermistor and a thermocouple, disposed in an oral-nasal region, such as between the mouth and nose, to acquire respiratory airflow changes, wherein two detection points can be selectively disposed near the nostrils, or three detection points can be selectively disposed near the nostrils and the mouth.

Still another option of the physiological sensing element is an accelerometer, for example, a three-axis accelerometer, which is usually disposed on a circuit board in the device housing and can be used to detect information such as body posture and body activity, and if used during sleep, can provide information such as sleep posture and sleep body activity, wherein the three-axis accelerometer returns acceleration values measured in all directions of x, y and z dimensions, and according to these values, the above-mentioned various information can be obtained, and further information related to sleep stage/state can be obtained by analyzing the body activity during sleep; alternatively, other kinds of accelerometers may be used, such as gyroscopes, magnetometers, etc. Furthermore, when the device containing the accelerometer is disposed on the body surface where the body surface vibration and fluctuation can be sensed, other physiological information can be detected, for example, the body cavity vibration caused by snoring can be detected, for example, the body cavity vibration can be obtained from the trunk, neck, head, ears, etc., wherein the trunk and head are the preferred obtaining positions, especially the nasal cavity, throat, chest, etc. can particularly well transmit the vibration caused by snoring, which is an advantageous option; can also be arranged on the trunk to obtain the acceleration and deceleration generated by the fluctuation of the chest and/or the abdomen in the breathing action; the blood vessel pulsation generated by the blood pulsation can also be detected to obtain the heart rate, and the obtaining position is not limited, for example, the head, the chest, the upper limb and the like can be obtained; in addition, the physical activity information acquired by the accelerometer can be used to determine whether the signal quality is poor due to physical movement or movement when analyzing the physiological signal.

The snoring can be detected by the accelerometer, and the body cavity vibration caused by the snoring can be detected by the piezoelectric vibration sensor, the setting position is the same as the accelerometer, or the sound detection is performed by the microphone without limitation, wherein the microphone can return the frequency and the amplitude of the detected sound, and the sound in the sleep, such as the snoring or the breathing sound, can be detected by the proper filter design of the acoustic transducer (acoustic transducer).

Alternatively, the breathing action may be detected by other physiological sensing elements, for example, a piezoelectric action sensor is disposed on the trunk, which obtains a signal by applying a force to the piezoelectric action sensor through the breathing action, and is usually implemented in a belt form surrounding the trunk, or may be implemented in a patch fixing form; still another option is a RIP (Respiratory inductance mapping) sensor, which is mounted on the torso to acquire the chest and/or abdomen expansion and contraction caused by breathing, usually in the form of a belt around the torso.

In another embodiment, the physiological sensing element is a temperature sensor for detecting the temperature of the device, the ambient temperature or the body temperature, wherein, in order to obtain the body temperature information, the temperature sensor is preferably disposed on the surface of the housing contacting the body surface, or a temperature conductive material is disposed on the surface of the housing for transmitting the temperature signal to the temperature sensor, or a radiation-induced temperature sensor can be used without contacting the skin.

All elements, modules, parts and the like required for physiological detection are prepared, the whole volume is only slightly larger than the volume of the adopted battery, for example, the length, the width and the height fall within the range of 10 × 10 × 10 mm to 20 × 20 × 20 mm, for example, 18 × 18 × 12 mm, the miniaturized physiological device is really achieved, and the device can be suitable for the targets of a plurality of position curves of a human body, for example, narrow setting positions of fingers, ears and the like.

The following describes various possible embodiments of the present microphysiological device.

In order to make the micro-shell not only be able to be disposed at the common positions of the general physiological apparatus, such as the wrist, the sole, the trunk, etc., but also be able to be disposed at other micro body surface disposing spaces, such as the finger tips, the ears, the head behind the ears, the forehead, etc., the application adopts a manner of matching with various suitable wearing structures to achieve the change of the disposing positions.

One embodiment is to adhere the microshell to a human body surface. The adhesion method has the advantages of good fixing effect on various fluctuant body surface areas, and unlimited arrangement and use of various physiological sensing elements, such as the physiological sensing element can be arranged at the most suitable sampling position, the contact between the shell and the skin can be more stable, and the like.

In the embodiment, an adhering structure is provided to make the housing tightly adhere to a body surface area of a user, as shown in fig. 3A-3G, wherein the adhering structure includes an attachment structure 30 and an adhering substance 31, the attachment structure 30 forms an attachment with the housing 100, and the adhering substance 31 is used to adhere the attachment to the skin surface, wherein the attachment has a protruding edge 302, which includes an upper surface and a lower surface, and is implemented to be disposed on the body surface area with the lower surface facing the skin.

In one embodiment, the attachment structure is combined with at least a portion of the housing to form the attachment, wherein the attachment structure has a receiving space 301 for receiving the housing 100, and the protruding edge 302 extends from the edge of the receiving space, so that the bottom edge of the micro-housing has a structure for fixing, especially the lower surface of the protruding edge is used for contacting the contact surface, and the increased surface area is beneficial to providing a space for disposing the adhesion substance and stabilizing the disposition of the bottom surface of the lower housing. It should be noted that the protruding edge may be implemented to surround the accommodating space for a circle, may be implemented to fall on two opposite sides, or other positions, and may also be changed according to the actual requirement without limitation.

As shown in fig. 3A-3B and fig. 3E, the adhering substance 31 can be directly applied to at least a portion of the lower surface of the protruding edge for adhering, and the adhering effect can be achieved without limiting the area and range; alternatively, as shown in fig. 3C-3D and fig. 3F-3G, an adhesive member 32 is used to carry the adhesive material 31, that is, the adhesive material is disposed on at least one surface of the adhesive member facing the body surface area, so as to achieve adhesive fixation by covering at least a portion of the adhesive member, wherein the range covered by the adhesive member may be at least a portion of the upper surface of the protruding edge 302 as shown in the figure, or the entire adhesive member (not shown), without limitation, as long as the adhesive fixation effect can be achieved.

The accommodating space and the micro-housing are combined with different possibilities, for example, fig. 3A-3C show a covering attachment structure, wherein fig. 3A shows that the accommodating space entirely covers the housing, and fig. 3B-3C show that the housing further has a combination step, and the top of the accommodating space is implemented to have a hole corresponding to the combination step, so as to achieve a fixing effect by utilizing the clamping between the combination step and the hole, which is particularly suitable for an embodiment having a physiological sensing element on the upper surface, for example, an embodiment in which an electrocardiograph electrode is arranged on the top surface for contacting with the upper limb; in addition, fig. 3F-3G show an attachment structure in the form of a base, which allows the housing to be placed from above, providing another operation option, for example, the attachment structure may be first placed on the body surface area, and then the housing is placed, in which case the receiving space and the housing may be combined with each other by magnetic attraction and/or mechanical engagement, or the receiving space may be made of an elastic material such as silica gel, and may be combined by sleeving. Thus, there are various possibilities, without limitation.

The attachment structure may be made of various materials, for example, plastic may be used, which is light in weight, has certain elasticity and rigidity, and facilitates the attachment to the body surface and the fixation, and particularly, as shown in the embodiment of fig. 3A to 3C, may be implemented in the form of a blister, simplifying the manufacturing process, reducing the cost, and when implemented as transparent plastic, it is visually almost equal to only the case being placed on the body, further providing aesthetic advantages; or, other materials, such as silica gel, non-woven fabric, etc., can be adopted, so that the soft material has the advantage of softness, and can also provide the functions of accommodating the shell, adhering to the body surface and being easily fixed; moreover, the receiving space and the protruding edge may be made of different materials, for example, the receiving space is made of a hard material to achieve the effect of fixing the housing, and the protruding edge is made of a soft material to adapt to the fluctuation of the body surface, so that various possibilities are available without limitation. Furthermore, the attachment structure and/or the adhesive member may further be embodied in a disposable form to provide convenient user options.

In another embodiment, the attachment structure is integrally formed with the housing as shown in fig. 3D-3E, that is, the housing itself has a protruding edge, so as to further simplify the structure, facilitate the process simplification and reduce the cost.

In particular, the attachment base structure and the housing as shown in fig. 3G provide an embodiment in which the optical sensor can still obtain the physiological information of blood through the bottom surface of the lower housing when the base structure is adopted, wherein the bottom surface of the housing is implemented to have a protrusion structure 181 for the optical sensor to be disposed, and correspondingly, the bottom of the accommodating space of the base attachment structure is implemented to have an opening for the protrusion structure to pass through, so that when the micro-housing is combined with the attachment base structure, the top end of the protrusion structure can pass through the opening, and the optical sensor disposed therein can also obtain the physiological information, for example, the protrusion structure can be configured to form the same plane with the lower surface of the protrusion edge, or be slightly convex, or slightly concave, without limitation.

The internal structure of the protruding structure 181 is shown in fig. 4, wherein, in order to dispose the optical sensor 20 in the protruding structure, the optical sensor is first combined with a block-shaped circuit board 161 to form an optical sensor module, and then the optical sensor module is mounted on the circuit board 16 to be electrically connected with the control unit, so that, through the height of the block-shaped circuit board, the optical sensor can enter the protruding structure downwards, so that the light generated by the light source can smoothly enter the human body, and the light reflected by the optical detector can be smoothly received. As mentioned above, the whole lower housing may be made of a light-permeable material, or only the protruding structure may be made of a light-permeable material, or a lens or a light-permeable material may be disposed on the lower edge of the protruding structure, which may be implemented in various ways without limitation.

Alternatively, instead of being implemented in a form having a protruding edge, a form without a protruding edge may be implemented, in which case, the above-mentioned adhesive can be directly used to fix the housing by covering, for example, directly using the adhesive to cover and adhere the housing without a protruding edge, or the base structure can be implemented without a protruding edge and covered and fixed by the adhesive, so that there are various possibilities without limitation.

On the other hand, while primarily utilizing electrophysiological input/output elements, other implementations are possible, as shown in fig. 5A-5B, which can be achieved by an electrically extending base structure 50 in combination with the housing 100. The electrically extending base structure includes a main housing 501 and an extending body 502 extending from the main housing 501, wherein the main housing is at least composed of an upper housing and a lower housing, for example, by ultrasonic bonding, and the upper housing is configured to have a receiving space for disposing the micro housing, and an in-housing space is formed between the upper housing and the lower housing for disposing a circuit substrate (not shown); the circuit substrate may be implemented in various ways, for example, a rigid circuit board, a flexible circuit board, etc. may be used to support the electrical components, and other materials may be used, for example, a substrate capable of supporting printing ink, without limitation. The extending body has one upper surface and one lower surface facing the body surface and is made of elastic material, such as flexible circuit board or silica gel to bear electric connecting wire, etc. to fit the curve of the body surface.

In addition, the base structure of the electrical extension also includes at least two electrical contact parts 503 and at least two electrophysiological input/output devices 504, wherein the at least two electrical contact parts are disposed on the circuit substrate of the inner space of the housing and exposed in the accommodating space to make electrical contact with the at least two electrical contact parts 101 on the bottom surface of the micro-housing when receiving the micro-housing (see fig. 1), and in this case, the electrical contact parts contacted on the micro-housing are electrical contact parts used for performing electrical extension or as electrodes besides charging and communication, and the difference between the two is only whether the housing can directly obtain electrophysiological signals by using the electrical contact parts when used alone, which can be changed according to actual use requirements without limitation, and furthermore, the at least two electrophysiological input/output devices 504 are disposed on the extension 502, and is electrically connected to the at least two electrical contact parts 503 in the accommodating space, so as to achieve the electrical connection between the at least two electrophysiological input/output devices and the control unit in the micro-housing, thereby performing the related electrophysiological operations through the electrophysiological input/output devices.

Such an advantage is that only the electrical extension base structure needs to be changed to adapt to different sampling requirements, e.g. to change the kind of the electrophysiological input/output element and/or to change the distance between two electrophysiological input/output elements, etc., the same miniature housing body can be quickly and simply changed by only changing different electrical extension base structures, which is quite cost-effective, and in addition, under such a structural design, the electrical extension base structure is quite simple and very low in cost, and can also be implemented in a disposable form based on hygienic considerations, which is quite advantageous.

As mentioned above, the electrophysiological input/output device can be used to obtain electrophysiological signals, such as electrocardio signals, electroencephalogram signals, electro-oculogram signals, myoelectric signals, and skin electric signals, and can also be used to detect impedance signals, such as respiration, or can be used to perform electrical stimulation, and the structure of the electrical extension base can be varied according to different purposes.

For example, in a preferred embodiment, as shown in fig. 6, the two electrical input/output devices 504 on the extension body 502 are implemented by mechanically and electrically connecting to the connectors 601 and 602, respectively, and then mechanically and electrically connecting to a button electrode 603 by using the connectors, so that the electrophysiological signals can be captured by the button electrode, for example, according to the different installation positions, the cardiac electrical signal, the brain electrical signal, the eye electrical signal, the muscle electrical signal, and/or the skin electrical signal can be obtained, the impedance signal can be detected, and the electrical stimulation can be performed, wherein, as shown in the figure, the connectors 601 and 602 are mechanically and electrically connected to the electrophysiological input/output devices 504 by using an up-and-down-riveting method, which is not only simple in process and good in connection and fixation effect, but also can be adapted to button electrodes of different combination forms, for example, when there are button electrodes of different types in the form of male buttons or female buttons, it is convenient to change the form of the engaging member.

The button electrode to be bonded may be a wet electrode or a dry electrode. When the button electrode is implemented as a wet button electrode, the adhesion between the wet electrode and the skin can be utilized to generate the effect of fixing the electrically extending base structure combined with the wet electrode on the body surface, and the adoption of the wet electrode is also beneficial to executing electrical stimulation; when the dry button electrode is implemented, the dry button electrode can be fixed by the adhesive before the connector is fastened, so as to fix the electrically-extended base structure. The button electrode has the advantages that the button electrode is combined, the contact between the electrode and the skin is independent of the extending body, the button electrode can be relatively more stable, the quality of the obtained electrophysiological information is improved, the provided electrical stimulation can be more stable, in addition, the button electrode can be independently replaced due to the fact that the button electrode is in a removable form, for example, a wet electrode can be replaced after viscosity is lost, the whole electrical extending base structure does not need to be replaced, the cost can be saved, in addition, the button electrode can be suitable for various electrophysiological signal acquisition, impedance signal detection and/or electrical stimulation providing only by changing the setting position according to different requirements and correspondingly replacing the proper button electrode, and the button electrode has the advantages.

In another embodiment, the electrical input/output element on the extension body can also be directly used as an electrode, i.e. the electrophysiological signal acquisition is performed by directly contacting the skin, therefore, the material of the extension body is preferably flexible and can be adhered to the body surface, so as to provideHigh use comfort. For example, one possibility is to use a flexible circuit board as the extension body, for example, the extension body is formed by directly extending the circuit substrate outward, in this case, an electrical contact pad (pad) formed on the flexible circuit board can be directly used as an electrode, and this technique of directly using the electrical contact pad as an electrode can be found in, for example, the manufacturer of wearable electroencephalogram detecting device^TMThe produced Muse S, Muse 2 and other series products are not described again; FIG. 7 shows an embodiment of the structure used for the forehead to obtain EEG/EEG signals, wherein the electrical extension base structure is further combined with a carrying structure 70 to be disposed on the forehead of a user, and as shown in the figure, the electrical contact pads 5041 on the extension body 502 are exposed, so that when the electrical contact pads are disposed on the forehead, the exposed electrical contact pads can directly contact the forehead to capture EEG signals, and then the carrying structure 70 is fixed, for example, a belt body passing behind the forehead can be combined to achieve a surrounding fixation, which is convenient; alternatively, an electrode, such as a dry electrode or a wet electrode as described above, may be further disposed on the electrical contact pad to further stabilize the electrode contact, and thus, there is no limitation.

In addition, particularly, it can be implemented in the form of necklace disposed at the front of the trunk to obtain the electrocardiographic signals, in this case, as shown in fig. 8, a neck wearing structure 80 is used to dispose the housing at the front of the trunk, the neck wearing structure has a neck fixing part 801 for fixing by using the neck, and a trunk contact body 802 for combining with the electrically extending base structure and further serving as a medium for the hand pressing to make the electrodes contact the trunk, wherein the trunk contact body has two electrophysiological signal extraction electrodes 803, for example, dry electrodes, and correspondingly two electrical connection abutting parts 804 for achieving the electrical connection between the electrophysiological signal extraction electrode 803 on the trunk contact body and the electrophysiological input/output element 504 on the extension body at the same time of combining, and then, by facing the two electrophysiological signal extraction electrodes on the trunk contact body toward the trunk when worn, the purpose of obtaining the electrocardiosignal by pressing the electrode to contact with the skin when the user needs to be provided is also an embodiment with great advantages.

Furthermore, as shown in fig. 9, based on the small volume of the micro-housing of the present application, it is also suitable to be disposed in the oral-nasal area, and therefore, the electrophysiological input/output device can also be implemented as a respiratory airflow sensor 901, such as a thermistor, a thermocouple, etc., in which case the electro-extension base structure is disposed in the oral-nasal area, such as between the oral cavity and the nose, and/or on the cheek, and the position of the electrophysiological input/output device, as mentioned above, needs to be disposed at a position where the change of respiratory airflow can be sensed, such as near the nostril, near the oral cavity, and therefore, is preferably disposed on the upper surface of the extension body, and here, the fixation of the electro-extension base structure has different possibilities, such as directly disposing an adhesive substance on the lower surface of the extension body for adhesion, or, as shown, fixing both ends of the extension body by using an adhesive member, can be changed according to the actual shape and the arrangement position without limitation. In addition, the position of the accommodating space for disposing the housing 100 on the extending body may also be different according to the requirement, so as to adapt to different requirements of use and installation, for example, the accommodating space may be disposed in the center of the extending body, so that the housing is located between the mouth and the nose, or may be disposed on one side of the extending body, so that the housing is located on the cheek. Therefore, there are various possibilities without limitation.

In these cases, the length and shape of the extending body are determined according to the position of the electrical input/output element to be disposed, for example, the extending body can be a long bar shape with various sizes, or an irregular shape, and it is convenient to fix/dispose the electrical extending base structure and then combine the micro-housing.

Further, in the case of the electrical extension base structure, the optical sensor can be used to obtain the blood physiological information, and in order to ensure that the optical sensor can obtain good physiological signals from the skin, it is preferable that, as shown in fig. 10, the lower surface of the micro-housing is implemented with a protrusion structure 181 for disposing the optical sensor, and correspondingly, the bottom of the accommodating space of the electrical extension base structure is provided with an opening for the protrusion structure to pass through, so that, when the micro-housing is combined with the electrical extension base structure, the top of the protrusion structure can pass through the opening, and the optical sensor disposed therein can obtain the physiological information, for example, the protrusion structure can be configured to form the same plane with the extension body, or be slightly convex, or be slightly concave, similar to the case shown in fig. 3G, and the protrusion structure has a similar structural design, therefore, the description thereof is omitted.

Therefore, the optical sensor and the electrophysiological input/output element can capture physiological information, for example, the optical sensor can simultaneously obtain blood oxygen concentration and electroencephalogram signals when being arranged on the forehead, can simultaneously obtain heart rate and electrocardiosignals when being arranged on the trunk, and can simultaneously obtain respirator flow change, blood oxygen concentration and the like when being arranged in the mouth-nose area, thereby being beneficial to further understanding the physiological state of a user; moreover, with such a design, the optical sensor, which is costly and has a complicated electrical connection, can be reused with the housing, in case the electrical extension base structure is implemented to be replaceable or disposable, which is very cost-effective.

Thus, the combination of the micro-housings with the attachment base structure and/or the electrically extending base structure may provide additional advantages. As mentioned above, the bottom surface of the housing is provided with the electric contact members for charging and/or communication in addition to the electric contact members for electric extension, so that the problem of electric safety that may occur when the housing is disposed on the body surface area needs to be considered, in this case, the contact between the electric contact members for charging and/or communication and the skin can be effectively isolated by using the base structure, for example, in the attached base structure as shown in fig. 3G, since the bottom of the accommodating space is only provided with the opening corresponding to the protruding structure, the isolation effect can be naturally achieved when the electric contact members for charging and/or communication are disposed at other positions than the protruding structure; in addition, in the electrical extension base structure shown in fig. 5A, which does not have the protruding structure, the entire bottom surface of the housing is isolated, and as in the case of the protruding structure shown in fig. 10, similarly, the charging/communication electrical contact component can be disposed at other positions than the protruding structure, so as to achieve the isolation effect.

Alternatively, when the base structure is not adopted, the effect of isolating the electrical contact can be achieved by other methods. For example, as shown in fig. 11, an insulating layer 110, such as a thin silicone sleeve, may be wrapped around the housing to cover the electrical contact elements on the bottom surface. Thus, there are various possibilities, without limitation.

Further, the charging and/or communication device can be further implemented to have a charging base structure, a communication base structure, or a charging communication base structure, which is combined with the housing to perform the charging and/or communication procedure. Here, similar to the base structure, it is preferable that, as shown in fig. 12, the charging/communication base structure 120 has a receiving space for receiving the housing, and a charging/communication electrical contact member 1201 is provided in the receiving space for making electrical contact with the charging/communication electrical contact member on the housing; in addition, the charging/communication base structure further includes a communication interface 1202, such as a USB interface, for connecting with an external device to perform a charging/communication procedure. Here, particularly, if the housing with the protruding structure is received, the bottom of the accommodating space needs to be provided with a corresponding opening 1203, and if the housing without the protruding structure is received, the bottom of the accommodating space can be optionally provided with or without an opening without limitation.

Further, when the housing is fixed to the receiving space of the attachment structure and/or the base structures by magnetic force, it is preferable that at least one first magnetic substance 102 is disposed in the housing (see fig. 1) and at least one second magnetic substance is disposed in the receiving space (not shown) respectively, so as to achieve the purpose of mutual combination by magnetic attraction between the paired magnetic substances, and it is more advantageous that the principles of like-polarity attraction and opposite-polarity repulsion between the magnetic substances are utilized, and the designed positions of the magnetic substances on the housing and the receiving space respectively are utilized to further provide the effects of orientation, limitation, etc., for example, the magnetic substances are preferably disposed at off-center positions, such as off-center positions or off-center positions, so as to ensure the correctness of the combination direction, furthermore, it is important to avoid the phenomenon of error in contact position easily occurring when the housing is implemented in a circular, square, rectangular or other symmetrical shape, and furthermore, more than two pairs of magnetic materials can be used, so that the positioning effect is better by using the magnetic difference, and the binding force between the two can be more even due to the increase of the stress points, so that the incomplete contact can be avoided.

Here, since the volume of the housing is small, in order to achieve the effects of orientation and position limitation, it is preferable to use a small-sized magnetic substance to avoid the situation that the magnetic field range is larger than the housing and the expected effect cannot be achieved; in addition, the first magnetic substance on the micro-housing may be disposed inside the housing, or embedded in the wall of the housing, for example, integrally formed with the housing, or attached to the outer surface of the housing, for example, after the housing is formed, the magnetic substance is attached by an adhesive, which may be implemented variously without limitation.

Furthermore, when the coupling between the miniature housing and the base structure involves electrical contacts, such as charging/communication base structures, and electrical extension base structures, there are many possibilities how the electrical contacts between the housing and the base structure can be made and maintained as well. In a preferred embodiment, a pin connector (pago pin) is used, wherein the electrical contact elements on the housing and the electrical contact elements on the base structure are paired with each other, for example, together for performing an electrophysiology operator, and together for performing a charging and/or communication procedure, at least one of the electrical contact elements of each pair of electrical contact elements being implemented as a pin connector, so that by virtue of the telescopic nature of the pin connector being stressed, an electrical contact between the two is ensured, as shown in fig. 13, by the electrical contact elements 101 on the lower surface of the housing being paired with the electrical contact elements implemented as pin connectors 130 in the base structure.

Particularly, in practical implementation, it is important to have a good distribution because a plurality of pairs of electrical contact members are provided at the same time for various purposes, for example, both electrical extension electrical contact members and charging/communication electrical contact members are provided. First, in the case of a certain volume of the thimble connectors, if all the thimble connectors are disposed in the housing, the housing will be oversized, and if all the thimble connectors are disposed in the base structure, although a larger space is available for accommodation, if the base structure is implemented as a disposable, e.g., a disposable electrically extendable base structure, this leads to a cost increase, and further, as is known, the thimble connectors have a telescopic elastic force, and when a plurality of thimble connectors are used in parallel, the stretching elastic forces are added to each other, and especially when more than three electrode contact points (constituting a plane), a greater binding force will be required to overcome the sum of the stretching elastic forces, the bond between the housing and the base structure is ensured and each pair of electrical contacts is made, for example, when the magnetic attraction method is used for bonding, the magnetic force of attraction must be larger than the sum of the elastic forces of the two to ensure the bonding and stable achievement of the plurality of electrical contacts. Therefore, it is preferable to separate the header connectors into the housing and base structure, thereby allowing for more even distribution of volume, cost, flex, and the like.

Accordingly, in practical implementation of the present invention, the pin connector of the plurality of pairs of electrical contact members is divided into two parts, that is, a first part of the pair of electrical contact members and a second part of the pair of electrical contact members, for example, since the electrophysiological signal extraction procedure and the charging/communication procedure are not performed simultaneously, the first part of the pair of electrical contact members can be implemented for charging/communication and the pin connector is disposed on the energizing/communication base structure, and the second part of the pair of electrical contact members can be implemented for electrical extension and the pin connector is disposed on the housing, for example, when charging/communication is performed using the USB port, 4 pairs of electrical contact members are required, and further, for electrical extension, 2 to 5 pairs of electrical contact members are required depending on the number of electrodes, so that, in addition to effectively reducing the volume of the housing and the cost of the base structure, the number of the pin connectors to be overcome for each combination between the housing and different base structures can be reduced, which is helpful for easily and stably achieving electrical contact, and particularly, when the magnetic force is used for attraction combination, the reduction of the required combination magnetic force also enables the volume of the magnetic substance to be kept small, which is helpful for the miniaturization of the volume of the housing.

In this way, according to the various embodiments described above, the micro-housing of the present invention can be installed at various positions of the human body, the physiological sensing element can be accurately installed to obtain stable and high-quality physiological information, and the installation burden of the user is very small due to the small size, which is very advantageous.

Next, a description will be given of a more specific installation position, ear.

Generally, the ear is a good location for obtaining various physiological signals, for example, when an optical sensor is provided, blood physiological information such as heart rate and blood oxygen concentration variation can be obtained, when a signal acquisition electrode is provided, various electrophysiological signals such as electroencephalogram, electrocardio, electromyogram, skin electrical signal and the like can be obtained, and when other physiological sensing elements are provided, other physiological information such as body temperature variation, body activity information, respiration status, snoring related information and the like can be obtained. However, the ear is difficult to be installed in practice because of various limitations such as narrow space, limited position, and difficulty in fixing the casing.

The small volume of the miniature housing of the present application just breaks the above-mentioned limitations, and therefore, whether placed inside the ear, on the ear, or near the ear, becomes practical, as exemplified below by the various possibilities.

In one aspect, the simplest and most straightforward way is to adhere the blood vessel to the back of the ear, e.g., the hair-free hair and hair region behind the auricle, near the temporal lobe region of the cerebral cortex, as shown in fig. 14, the upper half region behind the auricle corresponds to the cerebral cortex under the skull, and when it is located at this position, the blood vessel can be fixed by using the above-mentioned various adhesion structures or base structures, e.g., adhesion structure, attachment base structure, electrical extension base structure, etc., and the physiological sensing element can have various options, for example, a light sensor can be provided to obtain the physiological signal of blood, wherein, in addition to obtaining the heart rate, the blood oxygen concentration can be obtained when the position below the auricle corresponds to the cerebral cortex; in addition, when the bottom surface and the top surface of the shell are both provided with the electrophysiological signal acquisition electrodes, the electrocardio signal can be obtained, or other electrophysiological signals such as an electroencephalogram signal, an electromyogram signal, a skin electrical signal and the like can also be obtained by combining the electrical extension base structure; further, other physiological sensors such as a temperature sensor, an accelerometer, and a microphone may be provided to acquire other physiological information such as body temperature information, physical activity information, and snoring-related information. Therefore, there is no limitation.

In this case, the housing can be hidden behind the auricle, and is not easy to fall off by means of adhesion, so that the shell can be applied to almost any occasions, such as exercise, daily life, sleeping and the like, and is very convenient; furthermore, as long as the adhesion structure adopts a covering form and provides a waterproof function, the adhesive can be used during bathing and swimming, and has more advantages.

In another aspect, the ear pad can be disposed on the ear by using a wearing structure (ear wearing structure). Because the casing size of this application is very little, the position that can't smoothly set up among the many prior art all becomes feasible, only needs the wearing structure (ear wearing structure) that designs suitable to reach.

First, in the case of a sufficiently small housing volume, it becomes possible to place the housing in the ear. Depending on the structure of the ear, the proper location for the shell in the ear is the space defined by the concha cavity 154 and the ear canal 150, as shown in fig. 15, and in order to allow the shell to be stably positioned therein, an in-ear retention structure 160 is employed in the present application, as shown in fig. 16A-16D.

In this space, first, since the ear canal is a passage for receiving sound, it is preferable that the housing is biased toward the concha cavity when installed, so as to prevent sound from outside from being blocked due to the housing blocking the ear canal, and especially, when used during daily life, it may need to be worn for a long time, so as to keep receiving sound from outside without affecting hearing, which is very important for improving safety of use. Here, as mentioned above, the lower casing is preferably made of a transparent material to facilitate the light of the light source to penetrate into the concha cavity, but may be formed by disposing a transparent lens or a transparent material.

Accordingly, the in-ear retention structure 160 according to the present invention is implemented to have a set of components 161 and a top-retaining component 162, wherein the set of components 161 is configured to couple with the housing 100, e.g., to wrap at least a portion of the housing and to place the housing into the pinna in a direction toward the bottom of the concha cavity, and the top-retaining component 162 protrudes from the set of components toward and abuts against the position of the tragus 151, such that the housing can be maintained at the position of the concha cavity by the action of the top-retaining component protruding against the tragus due to the middle of the tragus 151 and the concha cavity 154 being the ear canal opening.

Further, the purpose is achieved by changing the shape of the abutment member in order to allow sound to pass into the ear canal. As shown in fig. 16A-16D, when the in-ear retention structure is disposed in the auricle, at least one channel 163 is formed between the cover member and the tragus, for example, fig. 16A shows the channel 163 formed directly on the top member, and fig. 16B-16D show the at least one channel formed by the top member, the concha wall 155 of the concha cavity 154, and the tragus 151 together, i.e., the in-ear retention structure does not fill the entire space, but provides a path for sound to pass near the mouth of the ear canal, such that sound is not blocked from passing in and out, thereby improving safety of use.

In addition, besides the top-resisting part facing to the tragus, other top-resisting parts can be added, for example, the top-resisting part facing upwards to the concha wall 155 around the concha boat 156 and the top-resisting part facing to the concha wall opposite to the tragus position, so as to increase the stability of the arrangement.

Preferably, the integral in-the-ear retention structure, or the abutment member, is implemented as an elastic material, such as silicone, rubber, or other elastic material, which, in addition to increasing comfort of use, also provides cushioning and fine adjustment functions.

In addition to the optical sensor, other physiological sensing elements, such as an accelerometer, a temperature sensor, a microphone, an electrode, a piezoelectric vibration sensor, etc., may be added to obtain other physiological information, such as physical activity information, sleeping posture, snoring related information, electrophysiological signals, etc., without limitation.

Furthermore, it is another possibility to arrange the housing on the auricle. As described above, the housing of the present application is small in size and light in weight, and does not cause a burden even when it is installed on the auricle, wherein the installation can be achieved by magnetic force.

As shown in fig. 17A-17B, a magnetic attraction structure 170 is used to dispose the micro-housing on a auricle portion of an auricle, and comprises a receiving component 171, a connecting component 172, and a magnetic component 173, wherein the receiving component 170 is used to combine with at least a portion of the housing 100, and the connecting component 172 is used to connect the receiving component 171 and the magnetic component 173, so that, in use, the combined housing and receiving component can be located on one side of the auricle portion and the magnetic component can be located on the other side of the auricle portion, and the two components are opposite to each other and fixed on the auricle portion by the principle of magnetic attraction.

Here, there are various possibilities for implementing the accommodating part, for example, a surrounding manner (fig. 17A) may be used, or a form using a covering (fig. 17B) may also be implemented, without limitation. In addition, the deformation characteristics of the connecting member may be achieved in different ways, for example, the deformation characteristics may be achieved by the characteristics of the material itself, such as silica gel, rubber, etc., or the deformation characteristics may be achieved by selecting members in the form of ropes, chains, etc., without limitation. Furthermore, the magnetic component contains a magnetic substance to achieve the effect of magnetic attraction with the containing component and the shell, and there are several ways to achieve the effect of magnetic attraction, for example, the magnetic substance can be directly arranged in the shell, for example, between the lower shell and the circuit board, or embedded in the wall of the lower shell or attached to the bottom surface of the lower shell to generate attraction with the magnetic component, or the magnetic substance can be arranged on the containing component, as shown in fig. 17B, a magnetic substance 174 is arranged at the bottom and can also generate attraction with the magnetic component, so that various changes can be made according to actual needs without limitation. In addition, as can be seen from the above description, the accommodating component, the connecting component, and the magnetic component, in addition to the magnetic substance contained therein, may be made of the same material according to actual requirements, or may be made of different materials in combination, without limitation.

As known, the physiological structure of the auricle is divided into a cartilaginous part and an earlobe (without cartilaginous part), wherein the cartilaginous part is rigid, the earlobe located below is flexible, the magnetic force for fixing can be effectively controlled because the thickness of the auricle has not too large individual difference, and the shell of the present application has small volume and light weight, so that it is suitable for fixing on the auricle by setting magnetic force on two sides of the auricle, and the fixed position is not limited except for the common earlobe, for example, the area between the auricle 157 and the antihelix foot 158, that is, the upper half of the auricle, the concha boat 156, the concha cavity 154, etc. can be the position set by magnetic attraction, wherein the cartilaginous part provides better supporting force, and the shell and the physiological sensing element can be set more stably, it is an advantageous choice to help obtain high quality physiological information.

In addition, without limitation, in implementation, the housing may be disposed at a front side of the auricle or at a rear side of the auricle, which may be changed according to actual situations, and when the housing is disposed in the concha cavity and/or the concha boat at the front side of the auricle, preferably, the accommodating part may further extend out of the top abutting part to abut against the concha wall around the concha cavity and/or the concha boat, so as to achieve a further fixing effect, which facilitates a more stable housing disposition.

The magnetic attraction structure may be set according to various factors such as the physiological sensing element used, the type of the physiological information to be obtained, and the aesthetic degree during use, for example, when the optical sensor is used to obtain the physiological information of blood, the bottom of the lower housing is required to face the sampling position, and the sampling position depends on the type of the physiological information of blood to be obtained, such as blood oxygen concentration and/or heart rate; when an electrode is captured using electrophysiological signals, another electrode may need to be extended, for example, from the housing to be disposed at the same auricle, another auricle, or skull, depending on the type of electrophysiological signals obtained; the accelerometer also has a difference in setting position according to the physiological information to be acquired, for example, if the information related to snoring is to be acquired, the accelerometer needs to be set at a position where the body cavity vibration caused by snoring can be sensed, and if the information related to sleeping posture is to be acquired, the setting position is relatively unlimited; the temperature sensor needs to be arranged at a position where body temperature information can be obtained; the microphone needs to be located at a position where sound can be acquired. Therefore, the housing is not limited to be disposed on the front side or the rear side of the auricle, and can be changed according to actual requirements.

Another possibility is to place the housing behind the ear, between the pinna and the skull. This arrangement is achieved by the present application employing an ear front piece 180 and a connecting structure 190, as shown in fig. 18A-18C.

The ear front part 180 is arranged on the front side of an auricle and can be mutually clamped with the physiological structure on the front side of the auricle, thereby achieving the fixing effect; the connecting structure 190 comprises an anterior auricle portion and a posterior auricle portion, the anterior auricle portion further has a first engaging member 191 for mechanically engaging with at least a portion of the anterior auricle component, the posterior auricle portion further has a second engaging member 192 for mechanically engaging with at least a portion of the housing 100, and a relative force is generated between the anterior auricle portion and the posterior auricle portion, and the housing can be fixed to the posterior auricle side by the relative force.

That is, the positioning effect is achieved after the ear front part is engaged with the ear front physiological structure, and therefore, the ear front part of the connecting structure mechanically combined with the ear front part can be positioned on the ear, and then the positioning effect of the shell mechanically combined with the ear rear part and positioned on the ear rear side is achieved through the relative force application between the ear front part and the ear rear part. When the shell can be stably arranged at the back side of the auricle, the physiological sensing element can be arranged and the physiological information can be acquired with positive help. Physiological sensing elements that may be provided herein include, but are not limited to, light sensors, accelerometers, electrophysiological signal acquisition electrodes, temperature sensors, and microphones.

It should be noted that, the first coupling member and the front ear part, and the second coupling member and the rear ear part may be integrally formed or may be removable, depending on the actual implementation, without limitation.

There are various possibilities for implementing the ear front part and for engaging with the physiological structure of the auricle. For example, as shown in fig. 18B, the ear front part 180 can be implemented to have an in-ear part 181 and an extension rod 182, and the in-ear part 181 is engaged between the tragus 151, the intertragic notch 152, and the antitragus 153 to achieve the fixing effect; alternatively, as shown in fig. 18A, the in-ear component 180 may be implemented to have only an in-ear portion, in which case the in-ear portion is preferably implemented to at least partially abut against the physiological structure of the pinna, e.g., the concha cavity and/or concha wall 155, tragus 151, antitragus 153, etc., of the cymba concha, or to engage with the ear canal to achieve a secure effect; therefore, the implementation form of the ear front part is not limited, and it is the scope of the present application as long as it can be engaged with the physiological structure of the front side of the auricle to achieve the fixing effect. As for the mechanical coupling between the first coupling member 191 and the ear front part 180 of the connecting structure, it can be implemented without limitation to be mechanically coupled with the in-ear part 181 and/or mechanically coupled with the extension rod 182, and further, it can be implemented in a removable form, for example, the first coupling member can be implemented as a loop removably coupled with the extension rod, or the first coupling member can also be implemented as a sleeve removably at least partially covering the in-ear part, and thus, there are various implementation options and possibilities without limitation.

The connection structure also has different embodiments. In one embodiment, as shown in fig. 18A, the connection structure 190 is implemented as a flexible connection structure, and the anterior auricle portion and the posterior auricle portion of the flexible connection structure are magnetically attracted to achieve a relative force therebetween, wherein the anterior auricle portion further has a magnetic member 193 disposed between the first connection member 191 and the second connection member 192 and containing a magnetic substance, and another magnetic substance for achieving the magnetic attraction is disposed behind the auricle, which can be implemented as disposed on the second connection member 192 of the posterior auricle portion or disposed on the casing 100, wherein when disposed on the casing, it can be implemented as disposed inside the casing, embedded in the casing wall, or attached to the casing wall, etc., all being feasible.

Therefore, the magnetic force between the two magnetic substances is attracted, so that the magnetic piece of the ear front part and the combination of the ear back part and the shell can generate relative force application, and the shell can be fixed on the back side of the auricle.

The advantage of this embodiment is that the placement of the magnetic element on the anterior side of the auricle is not limited as long as it is of a suitable size, so that the housing behind the ear can also be placed in an optimal sampling position.

In another embodiment, as shown in fig. 18B-18C, the connecting structure 190 is implemented as an earhook structure disposed between the auricle and the skull, in which case, when the first connecting member 191 of the anterior portion of the earhook structure is mechanically connected to at least a portion of the anterior component 180, one end of the earhook structure is positioned, and then, the second connecting member 192 of the posterior portion of the earhook structure is mechanically connected to the housing 100, so as to further achieve the housing positioning, and the relative force application between the anterior portion of the ear and the posterior portion of the ear is achieved by the earhook structure having an elastic deformation characteristic, for example, the earhook structure can be made of plastic or memory metal, so as to provide the elastic deformation characteristic, thereby achieving the stable setting; furthermore, the first coupling member 191 may be further embodied to be movable on the extension rod of the pre-auricular part, e.g. up-and-down, rotational, etc., wherein by moving up and down, different auricle sizes may be accommodated, and a fixed component of the housing downward may be provided, whereas by rotating, a component of the housing closer to the skin, e.g. towards the back of the auricle, may be further provided, which is therefore advantageous; in addition, the second engaging member 192 can be further implemented to be movable and/or rotatable on the behind-the-ear portion of the ear-hanging structure, for example, by a silicone member removably sleeved on the behind-the-ear portion, which can help to place the housing and the physiological sensing element in the optimal position, for example, the housing can be moved to the position most suitable for sampling, and the contact angle between the housing and the auricle or the head can be adjusted by rotation, etc., which also has advantages. It should be noted that, in addition to being disposed above the auricle and between the skull as shown in fig. 18B, the ear-hooking structure can also be disposed below the auricle and between the skull as shown in fig. 18C without limitation.

Furthermore, no matter what type of connection structure is adopted, the ear front part can be implemented as an earphone, such as a wired or wireless earphone, so that the existing earphone of a user can be directly used as a support to arrange the miniature shell of the application, which is not only convenient, but also has cost effect; furthermore, the earphone can be implemented to generate audio according to the acquired physiological information and provide the audio to the user, for example, notify the user that a preset physiological state is reached, such as heart rate reaching a preset value, or a preset sleeping posture, and the like, and the audio generation can be implemented, for example, if the wireless earphone with the control unit, for example, a smart earphone, can directly wirelessly communicate with the control unit in the miniature housing of the present application through a preloaded program of each other and determine the audio, or if the wired or wireless earphone controlled by the computer device or the portable electronic device, for example, the wired or wireless earphone connected with the mobile phone or the computer, can wirelessly communicate with the preloaded program of the control unit in the miniature housing of the present application and the preloaded program of the computer device or the portable electronic device and determine the audio, thus, there are various possibilities, without limitation.

Therefore, even if the volume of the miniature casing is small enough, the ear with limited space can be arranged well and stably by matching with different wearing/ear wearing structures, and therefore, when the casing is matched with the ear wearing structures, an ear wearing physiological system is formed, which can cover most of sampling positions on the ear, and can adopt different physiological sensing elements in a variable manner, which is equivalent to an all-directional system.

In practical implementation, the ear-worn physiological system includes a micro ear-worn physiological apparatus and a plurality of ear-worn structures, wherein the micro ear-worn physiological apparatus includes, as mentioned above, a housing, a control unit, a physiological sensing element, a communication module, a battery, and the like, and the ear-worn structures include at least a first ear-worn structure and a second ear-worn structure, but not limited thereto, and can be implemented as more than two ear-worn structures, e.g., three or four, and herein, the ear-worn structure can be any wearing structure that can place the housing on or near the ear, e.g., an in-ear holding structure, a magnetic attraction structure, an in-ear component and connection structure, an adhesion structure, an attachment base structure, an electrical extension base structure, and the like, and therefore, the position where the physiological information can be obtained is not limited, and can be any part of the auricle, and can also be the skull, without limitation.

The shell and each ear wearing structure are implemented in a removable form, so that a user can selectively combine with the proper ear wearing structure according to different use habits, use requirements and the like and obtain corresponding physiological information, for example, if the user uses the earphone in the exercise period, the user can select a connecting structure matched with an earphone or a magnetic attraction structure or a wearing structure arranged at the back side of an auricle; if the pillow is used during sleeping, the ear internal maintaining structure can be selected to avoid discomfort caused by side sleeping; if the user is in the daily life, the user can select the user according to the personal use habit. In addition, it may be that the user is unable to adapt to a particular ear-worn structure or structures, such as the auricle, and the user may be provided with other options without being constrained by the system, which is advantageous.

Alternatively, the selection may be made according to the physiological information to be obtained, for example, when the blood oxygen concentration is to be obtained, it is preferable to arrange the light sensor at the bottom of the earlobe, the cavum concha, or the position behind the ear corresponding to the cerebral cortex, etc., when the heart rate is to be obtained, the light sensor may be arranged at any position on the ear, and in particular, in order to change the sampling position generated by changing the ear wearing structure, the light sensor may be further implemented to have three light sources as described above, which respectively provide three wavelength combinations, so as to provide the optimal sampling wavelength combination for different physiological information of blood; when the physical activity information, the sleeping posture and/or the snoring-related information are/is to be acquired, an accelerometer and/or a microphone are/is arranged on/near the ear to acquire the physical activity, acquire the sound and/or detect the position of the snoring body cavity vibration; to obtain electrophysiological signals, such as electroencephalogram, electrocardiograph, electromyography, and electrodermal signals, the electrodes on the housing can be implemented as reference electrodes for obtaining various electrophysiological signals, and can be disposed at any position of the ear, or on the same auricle, another auricle, or skull if other electrodes need to extend from the housing. The related settings and usage details, as well as other possible settings, are listed in the contents of the above-mentioned various physiological sensing elements and wearing structures, and are not repeated herein.

Therefore, the concept not only enables the same micro physiological device to exert the maximum benefit at the position of the ear, but also provides the user with the most choices, which is helpful for increasing the use will and increasing the use popularity, and has the advantages.

In addition to being able to be installed on/near different positions of ears by combining with different ear wearing structures, other body positions can be changed by changing the wearing structures, for example, between positions of fingers, wrists, soles, ears, trunk, the vicinity of mouth and nose, forehead, etc., so as to provide a multifunctional one-wearing physiological system.

In particular, when using light sensors, further implementation options are available depending on the number of light sources provided and the wavelength. As mentioned above, in the embodiment of the present application, in which the different positions can be changed by changing the different wearing structures, it is preferable to arrange the three light sources at the same time, so that the blood physiological information can be obtained smoothly no matter what the positions are arranged, thereby not only increasing the convenience of use, but also improving the use efficiency.

For example, the wearable physiological system includes a micro wearable physiological device and at least one first wearable structure and a second wearable structure, wherein the micro wearable physiological device includes a housing, a control unit, a communication module, a battery, and in particular, at least one first light source, at least one second light source, at least one third light source, and at least one photodetector, wherein the at least one first light source generates light having a first wavelength combination, the at least one second light source generates light having a second wavelength combination, the at least one third light source generates light having a third wavelength combination, and the at least one photodetector receives at least one of the light emitted from the at least one first light source, the at least one second light source, and the at least one third light source.

The shell can be selectively combined with the first wearing structure or the second wearing structure to be arranged in a first body area or a second body area, wherein when the shell is arranged in the first body area, the control unit can obtain first blood physiological information through the first light-emitting source, the second light-emitting source and the at least one light detector, and when the shell is arranged in the second body area, the control unit can obtain second blood physiological information through the third light-emitting source and the at least one light detector.

The first blood physiological information includes blood oxygen concentration and blood physiological information obtained by the first light source, the second light source and the photodetector, and accordingly, the first body area includes, but is not limited to, forehead, between mouth and nose, ears, fingers, soles and other positions; the second blood physiological information includes various blood physiological information, such as heart rate, respiratory behavior, etc., which can be obtained through the third light source and the photodetector, and the second body region includes body parts such as a head, a trunk, and four limbs.

In practical implementation, for example, the first wearing structure may be implemented as a finger wearing structure to obtain blood oxygen concentration at a fingertip, or the second wearing structure may be implemented as a magnetic structure to obtain heart rate and other blood physiological information from an auricle; or, the first wearing structure can be used as an attaching structure attached to the base structure to obtain the blood oxygen concentration at the forehead, or the second wearing structure can be used as an adhering structure attached to the trunk to obtain the heart rate and other blood physiological information; alternatively, the first wearing structure can be used as an adhesion structure to obtain blood oxygen concentration between the mouth and the nose, and the second wearing structure can be used as a wrist wearing structure to obtain heart rate and other blood physiological information from the wrist. Accordingly, various types of wearing structures can be used without limitation, such as the various types of wearing structures described herein, or various wearing structures commonly used in the art, such as a headband, a chest band, a patch, etc., without limitation.

Naturally, the present invention is also applicable to the transformation of different parts of the same physiological structure, for example, the first wearing structure can be used to obtain the blood oxygen concentration on the earlobe, the second wearing structure can be used to obtain the heart rate and other blood physiological information in the ear, or the first wearing structure can be used to obtain the blood oxygen concentration on the fingertip, and the second wearing structure can be used to obtain the heart rate and other blood physiological information on other knuckles.

Accordingly, in practice, there is no limitation on the position and wearing structure, and it is within the scope of the present application that the micro-shell can be installed at any position on the body where the blood oxygen concentration, heart rate, and other physiological information of blood can be obtained and the wearing structure (including ear wearing structure) can be used.

In another aspect, the micro physiological apparatus of the present application can also obtain physiological information during sleep. Since the housing has a small size and is fitted with a suitable wearing structure, the user is not burdened even when the housing is used during sleep, and the conventional case where the user is difficult to fall asleep due to the installation of various physiological sensors can be significantly improved, and thus the housing is really a suitable choice for use during sleep.

When used during Sleep, a frequent application is to check whether Sleep disordered breathing occurs, one of which is Sleep Apnea (Sleep Apnea), it is generally classified into three types: obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), and Mixed Sleep Apnea (MSA), the Obstructive Sleep Apnea (OSA) is mainly characterized in that a phenomenon of respiratory airflow reduction or cessation within a period of time is formed due to complete or partial obstruction of an upper respiratory tract during sleep, central sleep apnea (CS a) is caused by a problem in a mechanism of brain driving muscles to breathe, so that nerve driving of respiratory muscles is stopped for a short time, and Mixed Sleep Apnea (MSA) is a condition in which obstructive sleep apnea and central sleep apnea are mixed; yet another common sleep disordered breathing is snoring, a condition that produces noise due to the vibration of soft tissues as the upper airway passes during sleep.

OSA and severe snoring have been studied to be highly correlated with a number of clinical symptoms such as daytime sleepiness, depression, hypertension formation, ischemic heart disease, cerebrovascular disease, etc., and snoring is the most frequently accompanied symptom in OSA, and is also widely considered as a precursor phenomenon of OSA, both of which are caused by physiological phenomena of upper airway stenosis.

However, according to studies, it has been generally shown that snoring related to a sleeping posture occurs first, and more seriously, snoring starts to occur easily even when the user is not lying on his back, and then the snoring starts to progress to mild OSA, and the snoring starts to have a gradually decreased correlation with the sleeping posture, and further, the OSA severity changes from mild to moderate correlated with the sleeping posture to a severe condition that is less correlated with the sleeping posture, as a result, the upper airway stenosis progresses.

Sleep Position Training (SPT) is a method for improving postural OSA and postural snoring, and a new generation of postural Training devices has been developed in recent years, in which a posture sensor, such as an accelerometer, is provided at a suitable position of the body, such as the head, neck, chest or abdomen, and when it is detected that the user is lying down, the user is prompted to change the sleeping position to avoid lying down by generating a weak vibration alert. Many research reports have indicated that in this simple yet effective way, the patient is prevented from lying down during sleep, thereby greatly reducing the number of OSA events.

The micro physiological device of the application is suitable for detecting the sleep breathing disorder or training the sleep posture.

For example, blood Oxygen concentration obtained by the optical sensor can be used to obtain important indicators for estimating or detecting sleep apnea, Oxygen Desaturation Index (ODI) and hypoxia level, and heart rate and DC components obtained from the PPG signal can be used to derive respiratory behavior to understand the changes in sleep breathing; the impedance detection electrode, the accelerometer, the piezoelectric motion sensor, the RIP sensor and the like can obtain the breathing motion so as to know the fluctuation change of the chest and the abdomen; the information related to snoring can be obtained by an accelerometer, a microphone, a piezoelectric vibration sensor and the like; the accelerometer can be used for obtaining sleep posture, sleep body activity information and the like and further obtaining sleep stage/state related information, the temperature sensor can be used for obtaining body temperature information, the electrophysiological signal acquisition electrode can be used for obtaining an electrooculogram signal and an electroencephalogram signal so as to judge the sleep stage and also can be used for obtaining an electrocardiosignal so as to know the heart activity condition during the sleep. Moreover, because the shell is very tiny, the shell is not limited to be provided with only one device, and can be simultaneously provided at a plurality of parts of the body to obtain a plurality of kinds of physiological information, thereby being beneficial to more accurately judging the sleep physiological information.

When the miniature physiological device is applied to sleep posture training, the tactile warning unit electrically connected to the control unit, such as the vibration module, is arranged in the shell, so that the tactile warning required by posture change can be provided, such as vibration warning, and the miniature physiological device can be arranged on the body surface originally, such as by using the adhesion structure, and is provided with the protruding edge which can help the device to be more attached to the skin, so that the tactile warning can be more effectively transmitted to the human body, the sleep posture training effect is more remarkable, and the implementation details of the protruding edge are detailed in the front, so that the detailed description is omitted.

The main basis of the sleep posture training is the sleep posture, and in the present application, the sleep posture related information is obtained by using an accelerometer, and the obtained position is a proper position of the body, including the top of the head, the forehead, the ears, the mouth and nose, the chin, the neck, the chest, and the abdomen, and can be disposed on any body surface of the body, such as the front, the back, etc., as long as the position of the sleep posture can be obtained by conversion, wherein the trunk and the neck above the trunk are most representative.

The posture training is performed by activating a tactile alert when the sleep posture is detected to be in a predetermined posture range, such as lying on back, for a period of time (e.g., 5 seconds to 10 seconds), and the tactile alert is gradually increased/incremented in intensity until the sleep posture is detected to be out of the predetermined posture range, such as changing to a different sleep posture or a non-lying on back posture, the alert is immediately stopped, and if no change in posture is detected after a predetermined period (e.g., adjustable 10 seconds to 60 seconds), the alert is paused and restarted after a period of time (e.g., adjustable minutes); in some embodiments, the tactile alert is initially very short in frequency/duration and gradually increases until the user no longer assumes the supine position; there are several repetitions (e.g., 6) of the inter-alert interval (e.g., 2 seconds) regardless of the intensity of the alert.

The preset posture range may be set according to actual requirements, for example, the preset posture range may be changed according to different definitions of the lying posture, for example, when the accelerometer is disposed on the torso, the included angle between the normal of the torso plane and the normal of the bed surface may be set to be within a range of plus or minus 30 degrees, or when the accelerometer is disposed on the forehead, the included angle between the normal of the forehead plane and the normal of the bed surface may be set to be within a range of plus or minus 45 degrees due to more movements of the head, or when the accelerometer is disposed on the neck, the same set range as the head may be set. Therefore, there are various options without limitation.

The control unit is configured to generate a driving signal, and the tactile alert unit generates at least one tactile alert after receiving the driving signal, and provides the at least one tactile alert to the user to achieve the purpose of sleep posture training, wherein the driving signal is generated according to an alert behavior determined when the sleep posture related information is compared with a preset posture range and conforms to the preset posture range.

To sum up, the miniature physiological device of the application achieves unprecedented small and exquisite size through the configuration of the internal structure, so that the limitation of the setting position of a human body is broken through, almost all positions of the body surface can be set and physiological signals can be obtained, and the miniature physiological device is matched with various wearing structures which are skillfully designed and are suitable for all parts of the body, not only provides almost non-sensible wearing experience, but also breaks through the limitation of the use opportunity, can be easily used in daily life, exercise and sleep, and is really an innovative breakthrough for the physiological device in the wearing form.

The above detailed description does not limit the scope of the present invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions can occur, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (19)

1. A miniature ear-worn physiological device, comprising:

a shell at least comprising an upper shell and a lower shell;

a control unit, which is contained in the shell and at least comprises a microcontroller/microprocessor;

a light sensor electrically connected to the control unit and including at least one light source and at least one light detector;

a communication module electrically connected to the control unit;

a battery; and

a structure to be maintained in the ear,

wherein the content of the first and second substances,

the housing is disposed within an auricle of a user via the in-ear retention structure; and

the in-ear maintenance structure includes a set of parts and a top part, wherein:

the engaging member is configured to engage at least a portion of the housing and to position the housing with the lower housing facing a bottom of the concha cavity of the auricle; and

the abutting part is configured to extend from the set part to abut against the tragus of the auricle so that the shell is maintained to be disposed at the concha cavity, and

wherein the content of the first and second substances,

when the shell is arranged in the concha cavity, the at least one light-emitting source emits at least one light ray to enter tissues below the bottom of the concha cavity, and the at least one light ray is received by the at least one light detector after being reflected by blood in blood vessels so as to obtain blood physiological information of the user; and

at least one channel is formed between the sheathing member and the tragus for sound to pass through, thereby achieving the effect of not influencing the hearing of the user.

2. The apparatus of claim 1, wherein the at least one channel is implemented as at least one of: formed on the top piece and formed by the top piece, the concha wall of the concha cavity, and the tragus together.

3. The device of claim 1, wherein the in-ear retention structure further comprises a further abutment member extending from the sleeve member to abut against one of: at least a portion of a concha wall of the concha of the pinna, and at least a portion of the concha wall positioned relative to the tragus.

4. The device of claim 1, wherein the top piece is implemented by an elastic material.

5. The device of claim 1, further comprising at least one other physiological sensing element, electrically connected to the control unit, embodied as at least one of: electrodes, accelerometers, microphones, temperature sensors, and piezoelectric vibration sensors.

6. The device of claim 1, wherein the lower housing is embodied as one of the following, comprising: is made of a light-permeable material, at least a part of which is provided with a light-permeable lens and at least a part of which comprises the light-permeable material.

7. The device of claim 1, wherein the length x width x height of the housing is implemented to be less than 18 x 12 mm.

8. A miniature ear-worn physiological device, comprising:

a shell at least comprising an upper shell and a lower shell;

a circuit board, which is accommodated in the shell and is provided with an upper surface and a lower surface, wherein the lower surface faces the lower shell;

a battery arranged above the circuit board;

at least one magnetic substance; and

a magnetic structure for mounting the housing on an auricle portion of a user,

wherein the content of the first and second substances,

the circuit board is at least provided with:

a control unit at least comprising a microcontroller/microprocessor;

at least one physiological sensing element electrically connected to the control unit; and

a communication module electrically connected to the control unit,

wherein the content of the first and second substances,

this magnetism is inhaled structure and is included:

a housing part for combining with at least one part of the shell;

a magnetic member; and

a connecting part for connecting the accommodating part and the magnetic part, an

Wherein the content of the first and second substances,

the shell and the accommodating component are constructed to be positioned at one side of the auricle part through a deformation characteristic of the connecting component, the magnetic component is constructed to be positioned at the other side of the auricle part, and the shell is fixed on the auricle part through magnetic attraction between the magnetic component and the at least one magnetic substance; and

the control unit obtains at least one piece of physiological information from the auricle part through the at least one physiological sensing element.

9. The apparatus of claim 8, wherein the at least one magnetic substance is implemented as one of the following: the circuit board is arranged between the lower shell and the circuit board, embedded in the shell wall of the lower shell, attached to the bottom surface of the lower shell and arranged on the accommodating part.

10. The apparatus of claim 8, wherein the pinna portion is implemented to include one of: earlobe, and cartilaginous parts.

11. The apparatus of claim 8, wherein the at least one physiological sensing element is implemented as at least one of: light sensors, electrodes, accelerometers, temperature sensors, and microphones.

12. A miniature ear-worn physiological device, comprising:

a shell at least comprising an upper shell and a lower shell;

a control unit at least comprising a microcontroller/microprocessor;

at least one physiological sensing element electrically connected to the control unit;

a communication module electrically connected to the control unit;

a battery;

an auricle front part disposed at a auricle front side of an auricle of a user; and

a connecting structure for connecting the housing and the ear front part,

wherein the content of the first and second substances,

the connecting structure is provided with an ear front part and an ear back part, wherein the ear front part is provided with a first combining piece used for being mechanically combined with at least one part of the ear front part, the ear back part is provided with a second combining piece used for being mechanically combined with at least one part of the shell, and the ear front part and the ear back part can generate opposite force;

the ear front part is fixed by mutually clamping with the physiological structure at the front side of the auricle, so that the ear front part of the connecting structure is fixed, and then the shell is fixed at the back side of the auricle by the relative force application between the ear front part and the ear back part; and

the control unit obtains at least one piece of physiological information of the user through the at least one physiological sensing element.

13. The apparatus according to claim 12, wherein the connection structure is implemented as a flexible connection structure, and the auricle portion of the flexible connection structure further comprises a magnetic member disposed between the first coupling member and the second coupling member and containing a magnetic substance for generating magnetic attraction with another magnetic substance disposed at the posterior side of the auricle to achieve relative force application between the auricle portion and the auricle portion, and wherein the another magnetic substance is implemented to be disposed on one of the following: the second engaging member of the behind-the-ear part, and the housing.

14. The device of claim 12, wherein the connecting structure is implemented as an earhook structure disposed between the auricle and the skull, and wherein the earhook structure has an elastic deformation characteristic, and achieves the relative force application between the anterior portion and the posterior portion through the elastic deformation characteristic.

15. The device according to claim 14, wherein the ear front portion of the earhook structure is embodied to be movably coupled with the at least a portion of the ear front part.

16. The device according to claim 12, wherein the first coupling member is embodied in an integrally formed or removable form with the anterior ear portion and the second coupling member is embodied in an integrally formed or removable form with the posterior ear portion.

17. The device of claim 12, wherein the ear front part is further embodied as an earphone.

18. The device of claim 17, wherein the headset is configured to provide an audio to the user, the audio being implemented to be generated based on the at least one physiological information.

19. The apparatus of claim 12, wherein the at least one physiological sensing element is implemented as at least one of: light sensors, accelerometers, electrodes, temperature sensors, and microphones.

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