JP2016214731A - Vital sensor module and operation method therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a vital sensor module capable of extracting respiration components including a respiratory rhythm, a respiratory rate, and the existence of respiration, by paying attention to signal attitude variations in a pulse wave; and an operation method for the vital sensor module.SOLUTION: A vital sensor module 2 comprises: a substrate 20A; a light-emitting element 12 arranged on the substrate's surface; and a light-receiving element 14 arranged on the substrate's surface so as to be separated from the light-emitting element 12. The vital sensor module, when being made to be in contact with a body surface of a living body, receives reflected light that is light emitted from the light-emitting element and returned from the inside of the living body, by using the light-receiving element; and detects pulse wave signal strength on the basis of strength of the reflected light before individually arranging top and bottom peak values of the pulse wave signal strength's waveform in time series to acquire an envelope curve in which a respiratory rhythm has been reflected. Monitoring variations in signal amplitude in the pulse wave signal strength's region lower than a predetermined base line makes it possible to detect the respiratory rhythm, a respiratory rate, the existence of respiration, etc.SELECTED DRAWING: Figure 5

Description

  The present embodiment relates to a vital sensor module and an operation method thereof.

  When information related to the human body is acquired by a sensor, a motion sensor that captures movement and an optical sensor that obtains information using light are used other than those used in medical practice and blood glucose meters that directly measure blood itself.

  The pulse wave sensor can measure the blood flow of capillaries using an optical sensor that contacts the body surface, and can measure the pulse rate and pulse fluctuation from the fluctuation of blood flow due to the pulsation of the heart. . In the measurement using an optical sensor, blood oxygen saturation using light of two different wavelengths is used in addition to the pulse.

  On the other hand, in order to monitor respiration, a general method is to attach a respiratory band or a velocimeter to the breathing band or nasal cavity of the chest or waist.

JP 2012-19926 A JP 2012-19928 A JP 2012-19929 A JP 2012-120773 A US Patent Application Publication No. 2014/0051955 JP 2004-121668 A International Publication No. 2011/027438

  However, in order to monitor respiration, the method of attaching a pneumatic transducer or current meter to the breathing band or nasal cavity of the chest or lumbar region is very expensive, and it is difficult for a general person to wear it properly. Because it is difficult, it is necessary to go to a specialized institution and receive an examination in an environment different from the daily living space.

  In addition, these methods are strong in tightening devices and equipment on the body, and discomfort associated with wearing is also a major problem.

  The present embodiment is to provide a vital sensor module capable of extracting respiratory components such as respiratory rhythm, respiratory rate, and respiratory presence by focusing on the change in pulse wave signal amplitude, and an operation method thereof.

  According to one aspect of the present embodiment, a substrate, a light emitting element disposed on the surface of the substrate, a light receiving element disposed on the surface and spaced apart from the light emitting element, and on the surface A light-emitting element and a light-receiving element that are spaced apart from the light-receiving element, contact the body surface of a living body, and the light emitted from the light-emitting element returns reflected light from the living body by the light-receiving element. And detecting the pulse wave signal intensity based on the intensity of the reflected light, and arranging the peak values of the top and bottom of the waveform of the pulse wave signal intensity in time series, thereby creating an envelope reflecting the respiratory rhythm. A resulting vital sensor module is provided.

According to another aspect of the present embodiment, an optical sensor detects a pulse wave signal waveform, A / D converts the pulse wave signal waveform, and detects a bottom of the pulse wave signal waveform. The bottom n-th time of the pulse wave signal waveform is T _n , the bottom n-th signal intensity is B _n , the data is (T _n , B _n ), and the time interval D _n ( = T _n −T _n−1 ), and if it is 50% or 200% or more compared to the time interval (D _n−1 , D _{n + 1} ) before and after, it is eliminated as an error value, Substituting values (T _c , B _c ) supplemented from previous and subsequent time intervals into the data excluded as the error values, and for the data group (B ₀ , B ₁ ,..., B _n ,...) suitably performs the moving average processing, the step of the data group after the moving average process and _{(b 0, b 1, ...} , b n, ...) Each data (T _n, b _n) which has been subjected to moving average processing obtains the envelope by connecting, the obtained said envelope, by obtaining the peak value or bottom value per unit time, respiratory rate A method of operating a vital sensor module is provided.

According to another aspect of the present embodiment, a step of acquiring a pulse wave signal waveform by an optical sensor, a step of A / D converting the pulse wave signal waveform, and a peak and a bottom of the pulse wave signal waveform are obtained. The peak data of the pulse wave signal waveform is detected by _tn , the peak nth signal intensity is _Pn , the bottom nth time is _Tn , and the bottom nth signal intensity is _Bn. (T _n , P _n ) and bottom data as (T _n , B _n ), the difference between the peak signal intensity and the bottom signal intensity (P _n -B _n ) or (P _n -B _n-1 ) Is provided, and a method for operating the vital sensor module is provided. The method includes calculating the signal amplitude ΔH _n as time elapses, and monitoring the amount of change in the signal amplitude ΔH.

  According to the present embodiment, it is possible to provide a vital sensor module that can extract respiratory components such as respiratory rhythm, respiratory rate, and respiratory presence, and an operation method thereof by paying attention to changes in pulse wave signal amplitude.

(A) A schematic diagram showing a state of wireless communication with an external PC / portable terminal when the vital sensor module according to the first embodiment is mounted on the inner side of the forearm, and (b) according to the first embodiment. The schematic diagram which shows the mode of the radio | wireless communication with an external PC / mobile terminal by mounting | wearing the outer side of a forearm sensor module. (A) A schematic diagram showing a state of wireless communication with an external PC / portable terminal by mounting the vital sensor module according to the first embodiment on the inner side of the index finger, and (b) according to the first embodiment. The schematic diagram which shows the mode of the radio | wireless communication with an external PC / mobile terminal by mounting | wearing the outer side of a forefinger with a vital sensor module. (A) Schematic diagram showing how the vital sensor module according to the first embodiment is mounted at the entrance of the ear canal, (b) the vital sensor module according to the embodiment mounted on the ear canal and an external PC / portable terminal The schematic diagram which shows the mode of wireless communication. (A) Typical planar configuration example of the optical sensor portion of the vital sensor module according to the first embodiment, (b) Another schematic planar configuration of the optical sensor portion of the vital sensor module according to the first embodiment. Example. The typical cross-section figure of the state which mounted | wore the arm with the vital sensor module which concerns on 1st Embodiment provided with the optical sensor shown to Fig.4 (a). FIG. 6 is still another schematic plan configuration example of the optical sensor portion of the vital sensor module according to the first embodiment. FIG. 7 is a schematic cross-sectional structure diagram taken along line II of FIG. 6. The typical bird's-eye view block diagram of the vital sensor module which concerns on 1st Embodiment. The typical block block diagram inside the housing | casing of the vital sensor module which concerns on 1st Embodiment. The flowchart figure which shows the operating method of the vital sensor module which concerns on 1st Embodiment. FIG. 11 is a flowchart showing a detailed operation method between step S6 and step S7 in FIG. The measurement example of the relationship between the pulse wave signal strength (a.u.) and the number of samples S in the vital sensor module according to the first embodiment. 6 is another measurement example of the relationship between the pulse wave signal intensity (a.u.) and the number of samples S in the vital sensor module according to the first embodiment. In the vital sensor module according to the first embodiment, an example of measuring the number of breaths by the envelope of the relationship between the pulse wave signal intensity (au) and the number of samples S in FIG. 12 (number of samples S = 1000 to 6000 (pieces)) ). In the vital sensor module according to the first embodiment, an example of measuring the number of breaths by the envelope of the relationship between the pulse wave signal intensity (au) and the number of samples S in FIG. 12 (number of samples S = 6000 to 11000 (pieces)) ). In the vital sensor module according to the first embodiment, a measurement example of the relationship between the pulse wave signal intensity (a.u.) during apnea and the number of samples S (number of samples S = 1000 to 8000 (pieces)). In the vital sensor module according to the first embodiment, another measurement example of the relationship between the pulse wave signal intensity (a.u.) and the sample number S during apnea (sample number S = 1000 to 11000 (pieces)). The flowchart which shows the operation | movement method of the vital sensor module which concerns on 1st Embodiment. Explanatory drawing of the pulse-wave signal waveform corresponding to the operation | movement method shown in FIG. The flowchart which shows another operation | movement method of the vital sensor module which concerns on 1st Embodiment. Explanatory drawing of the pulse-wave signal waveform corresponding to the operation | movement method shown in FIG. In the vital sensor module according to the first embodiment, a measurement example of the relationship between the pulse wave signal intensity (a.u.) and the number of samples S during the operation of FIG. It is an example of a pulse wave signal waveform in a vital sensor module according to a comparative example, and (a) a typical example including ejected waves and reflected waves, (b) a waveform example including unnatural notches and inflection points of ascending legs, (C) Waveform example provided with deformation / amplitude change of reflected wave at systolic apex, (d) Waveform example provided with unnatural inflection line of descending leg. It is a pattern example of a pulse wave signal waveform requiring attention in a vital sensor module according to a comparative example, and (a) a systolic deformation example (notch type), (b) a systolic deformation example (tosaka type), (c) expansion Seasonal variation (Sazanami type). In the vital sensor module which concerns on 2nd Embodiment, the typical plane block diagram seen from the surface side which contact | connects a human body. In the vital sensor module which concerns on 3rd Embodiment, the typical plane block diagram seen from the surface side which contact | connects a human body. In the vital sensor module which concerns on 4th Embodiment, the typical plane block diagram seen from the surface side which contact | connects a human body. (A) Bird's-eye view of the optical sensor part of the vital sensor module which concerns on 5th Embodiment, (b) Explanatory drawing of Fig.28 (a). (A) Bird's-eye view of vital sensor module according to fifth embodiment, (b) Explanatory drawing of FIG. 29 (a). The typical block block diagram of the vital sensor module which concerns on 5th Embodiment. The circuit block block diagram of the vital sensor module which concerns on 5th Embodiment. The flowchart figure which shows the operating method of the vital sensor module which concerns on the 1st-5th embodiment. The flowchart figure which shows another operation | movement method of the vital sensor module which concerns on 1st-5th embodiment.

  Next, the present embodiment will be described with reference to the drawings. In the following description of the drawings, the same or similar parts are denoted by the same or similar reference numerals. However, it should be noted that the drawings are schematic, and the relationship between the thickness and the planar dimensions, the ratio of the thickness of each layer, and the like are different from the actual ones. Therefore, specific thicknesses and dimensions should be determined in consideration of the following description. Moreover, it is a matter of course that portions having different dimensional relationships and ratios are included between the drawings.

  In addition, the embodiment described below exemplifies an apparatus and method for embodying the technical idea, and does not specify the material, shape, structure, arrangement, etc. of the component parts as follows. . This embodiment can be modified in various ways within the scope of the claims.

[First embodiment]
(Vital sensor module mounting form)
A schematic diagram showing a state of wireless communication with the external PC / portable terminal 4 by mounting the vital sensor module 2 according to the first embodiment on the inner side of the forearm of the human body 18 is as shown in FIG. It is expressed in Moreover, the vital sensor module 2 which concerns on 1st Embodiment is mounted | worn with the outer side of the forearm of the human body 18, and the schematic diagram which shows the mode of wireless communication with the external PC / mobile terminal 4 is shown in FIG.1 (b). It is expressed as follows. As shown in FIGS. 1A and 1B, the vital sensor module 2 according to the first embodiment can be attached to the forearm of the human body 18 via the strap 50 for the arm.

  FIG. 2A is a schematic diagram showing a state of wireless communication with the external PC / portable terminal 4 by mounting the vital sensor module 2F according to the first embodiment on the inner side of the index finger 18F of the human body 18. It is expressed as shown in FIG. 2B is a schematic diagram showing the state of wireless communication with the external PC / portable terminal 4 by mounting the vital sensor module 2F according to the first embodiment on the outside of the index finger 18F of the human body 18. It is expressed as shown in As shown in FIGS. 2A and 2B, the vital sensor module 2F according to the first embodiment can be attached to the index finger 18F of the human body 18 via the strap 50F for fingers. Here, an example of attaching to the index finger 18F is shown, but the present invention is not limited to the index finger 18F, and other fingers may be used.

  A schematic diagram showing a state in which the vital sensor module 2E according to the first embodiment is attached to the entrance of the ear canal is represented as shown in FIG. 3A, and the vital sensor module according to the embodiment attached to the ear canal is shown. A schematic diagram showing a state of wireless communication between 2E and the external PC / portable terminal 4 is expressed as shown in FIG.

  Furthermore, the mounting example of the vital sensor module according to the first embodiment is not limited to the forearm 18, the index finger 18F, and the ear canal entrance, but may be another human body part.

(Optical sensor)
A schematic planar configuration example of the optical sensor 1 portion of the vital sensor module according to the first embodiment is represented as shown in FIG. 4A, and another schematic planar configuration example is shown in FIG. It is expressed as shown in

  The optical sensor 1 portion of the vital sensor module according to the first embodiment is disposed adjacent to one light emitting element (LED) 12 and the LED 12 as shown in FIG. And a single light receiving element (PD: Photodetector) 14. LED12 and PD14 are arrange | positioned on the board | substrate 20A. The LED 12 and the PD 14 may be surrounded by a light shielding resin wall (insulating layer) 21 disposed on the substrate 20A. Here, the LED 12 can emit visible light or near-infrared light. The PD 14 is a light receiving element having sensitivity in the same band as the LED 12 that emits visible light or near infrared light. When a plurality of PDs 14 are arranged, an optical filter may be provided on each of the plurality of PDs 14 and used separately. For example, an optical filter may be provided so that one PD 14 is sensitive to visible light and the other PD 14 is sensitive to near infrared light. The optical filter can be formed, for example, by being applied to a light receiving element or a resin package, but is not limited thereto.

  Moreover, in the vital sensor module 2 according to the first embodiment, the LED 12 includes a green light emitting diode and can measure a pulse wave.

  In the vital sensor module 2 according to the first embodiment, the LED 12 includes a red light emitting diode or an infrared light emitting diode, and can measure blood oxygen saturation.

Another configuration example of the optical sensor 1 portion of the vital sensor module according to the first embodiment is adjacent to _two LEDs 12 ₁ and 12 ₂ and LEDs 12 ₁ and 12 ₂ as shown in FIG. And one PD 14 arranged in this manner. The LEDs 12 ₁ and 12 ₂ and the PD 14 are disposed on the substrate 20A. The periphery of the LEDs 12 ₁ and 12 ₂ and the PD 14 may be surrounded by a light shielding resin wall (insulating layer) 21 disposed on the substrate 20A. Here, the LEDs 12 ₁ and 12 ₂ can emit visible light or near infrared light. The PD 14 is a light receiving element having sensitivity in the same band as the LEDs 12 ₁ and 12 ₂ emitting visible light or near infrared light.

(Vital sensor module)
FIG. 5 shows a schematic cross-sectional structure example in a state where the vital sensor module 2 according to the first embodiment including the optical sensor 1 shown in FIG. It is expressed in

  As shown in FIG. 5, the vital sensor module 2 according to the first embodiment is disposed in close contact with the human body (arm) 18 in a face-down manner, for example. In the example shown in FIG. 5, the vital sensor module 2 is in close contact with the human body (arm) 18, but may be arranged at a predetermined distance from the surface of the human body (arm) 18. Here, the predetermined distance is, for example, within several mm.

  The board 20 </ b> A can be formed of, for example, a printed circuit board (PCB) or the like, and is disposed in the module housing 10. A memory 8A, a control integrated circuit 8B, a resistance element 8R, a capacitor 8C, and the like are arranged on the front surface (the surface on the side in contact with the human body 18 is referred to as a back surface or a bottom surface) of the substrate 20A. Here, the resistance element 8R, the capacitor 8C, and the like are applied to components such as a delay circuit, for example.

  Moreover, as shown in FIG. 5, the battery 9 may be arrange | positioned through the columnar resin wall (insulating wall) 21B on the surface side of the board | substrate 20A. The battery 9 is also arranged in the module housing 10. The battery 9 and the electrodes on the substrate 20A are connected by a bonding wire 20W or the like.

  Furthermore, as shown in FIG. 5, the board 20 </ b> B may be disposed on the surface side of the board 20 </ b> A and the battery 9 via the connector 6 </ b> A. The substrate 20B is also disposed in the module housing 10. Here, the connector 6A connects the substrates 20A and 20B.

  As shown in FIG. 5, the optical sensor 1 is desirably disposed so as to protrude from the surface of the module housing 10.

  Further, the module housing 10 may be provided with a concave curved surface shape in accordance with the shape of the human body 18 part in a portion in contact with the human body 18 so that the adhesion between the human body 18 and the optical sensor 1 is facilitated. .

  The module housing 10 according to the present embodiment has, for example, adhesiveness on the surface, and the vital sensor module 2 may be attached to the human body 18 by the adhesiveness of the module housing 10. Good.

  Further, the module housing 10 may be made of a material having higher flexibility than other configurations of the vital sensor module 2, thereby improving the adhesion between the module housing 10 and the human body 18, As a result, the adhesion between the vital sensor module 2 and the human body 18 can be further improved.

  When the surface of the module housing 10 is made sticky, an extra configuration for bringing the vital sensor module 2 such as a belt into close contact with the human body 18 is not essential.

  Still another schematic plane configuration example of the optical sensor 1 portion arranged on the bottom surface side in contact with the human body 18 of the vital sensor module 2 according to the first embodiment is expressed as shown in FIG. A schematic cross-sectional structure along the line I-I is expressed as shown in FIG.

As shown in FIGS. 6 and 7, the optical sensor 1 of the vital sensor module 2 according to the first embodiment has a plurality of PDs 14 ₁ arranged on the PCB 20 around the LED 12 and surrounding the periphery of the LED 12.・ Place 14 ₂・ 14 ₃・ 14 ₄ In the example of FIG. 6, four PDs are arranged. In the example of FIG. 6, four PDs are arranged for one LED, but the configuration is not limited to this, and two PDs may be arranged for one LED. Further, four LEDs may be arranged for one PD. Two LEDs may be arranged for one PD.

Further, as shown in FIGS. 6 and 7, a black light shielding resin wall 21 is disposed on the surface of the PCB 20, and the LED 12 and the PDs 14 ₁ , 14 ₂ , 14 _3, and 14 ₄ are for light shielding. The resin walls 21 are separated from each other. An insulating layer colored black may be applied to the light shielding resin wall 21.

By arranging a plurality of PDs 14 ₁ , 14 ₂ , 14 _3, and 14 ₄ around the LED 12 so as to surround the periphery of the LED 12, the light information around the LED 12 can be effectively used for the plurality of PDs 14 ₁ , 14 ₂ , 14 _3, and so on. 14 ₄ , and can be applied to a photoelectric pulse wave sensor or the like to improve the operational stability. In addition, since the number of LEDs used is one, low power consumption operation is possible.

  Although not shown, an operation unit / display unit and the like are arranged on the top surface side of the vital sensor module 2 according to the first embodiment so as to be operated and observed by the subject and are in contact with the human body 18. An optical sensor, various sensors, and the like may be disposed on the bottom side.

  When the mounting state between the optical sensor 1 and the human body 18 is defective, as shown in FIG. 1A or 7, the main body moves in the X-axis / Y-axis / Z-axis directions, and the optical sensor 1. However, the vital sensor module 2 according to the first embodiment clearly displays the wearing state to the subject while maintaining the correct wearing state. Measurement can be performed. By making the mounting state explicit, it is possible to prevent measurement in a mounting failure state and always perform measurement in the correct state (correct value). It becomes possible to clarify the ideal state of wearing for the subject, and usability is improved.

  A schematic bird's-eye view configuration of the vital sensor module 2 according to the first embodiment is expressed as shown in FIG.

As shown in FIG. 8, the vital sensor module 2 according to the first embodiment includes a PCB 20, an LED 12 disposed on the surface of the PCB 20, and a PD 14 disposed on the surface of the PCB 20 so as to be separated from the LED 12. _1, 14 _2, 14 _3, 14 _4, on the surface of the PCB 20, LED 12 and PD 14 _1, 14 _2, 14 _3, 14 sensor 16, which is ₄ spaced apart from the arrangement _1, 16 _2, 16 _3, 16 ₄ The PD14 ₁ , 14 ₂ , 14 _3, and 14 ₄ receive reflected light from the light emitted from the LED 12 and returned from the living body to detect the intensity of the reflected light. In addition, the sensor can clearly indicate information on the contact state with the body surface based on the sensor output value detected by contacting the body surface.

Further, as shown in FIG. 8, a black light shielding resin wall 21 is disposed on the surface of the PCB 20, and the LED 12 and the PDs 14 ₁ , 14 ₂ , 14 ₃ , 14 ₄ , sensor (thermistor) 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ are separated from each other by the light shielding resin wall 21. An insulating layer colored black may be applied to the light shielding resin wall 21.

  The vital sensor module 2 according to the first embodiment may detect the wavelength, attenuation ratio, or phase difference of the reflected light.

  The sensor can determine the wearing state depending on whether the sensor output value is within the threshold range or outside the threshold range.

  In addition, the vital sensor module 2 according to the first embodiment may include a plane that contacts the body surface, and a surface that contacts the body surface may include a light receiving surface, a light emitting surface, and a sensor contact surface. Note that the surface in contact with the body surface is not necessarily a flat surface, and may be intentionally curved in order to fit the arm.

  Moreover, in the vital sensor module 2 according to the first embodiment, the LED 12 includes a green light emitting diode and can measure a pulse wave.

  In the vital sensor module 2 according to the first embodiment, the LED 12 includes a red light emitting diode or an infrared light emitting diode, and can measure blood oxygen saturation.

The sensor, as shown in FIG. 8, includes a thermistor 16 _1, 16 _2, 16 _3, 16 ₄ for detecting the temperature of surface in contact with the body surface when worn, the thermistor 16 _1, 16 _2, 16 ₃ - 16 depending on whether the measured value of ₄ is outside the threshold range or is within the threshold range, to determine the mounted state, it may be explicit information about mounting condition to the subject.

The thermistors 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ are also applicable to the measurement of the temperature of the human body 18 or the surface of the animal body. It is possible to estimate the body temperature from the temperature of the human body 18 or the surface of the animal body.

  Further, as shown in FIG. 8, the vital sensor module 2 according to the first embodiment is disposed on the surface of the PCB 20 (the surface on the side contacting the human body 18 is referred to as the back surface or the bottom surface here). A housing 10 may be provided.

  An example of a schematic block configuration inside the housing 10 of the vital sensor module 2 according to the first embodiment is expressed as shown in FIG.

  Here, in the vital sensor module 2 according to the first embodiment, the housing 10 includes a power supply unit 34, a wireless communication unit 32 connected to the antenna 36, a control unit 30, and an operation unit, as shown in FIG. 35, the display unit 40, or the storage unit 42 can be incorporated.

  Furthermore, the vital sensor module 2 according to the first embodiment may include an electronic circuit component arranged on the surface of the substrate 20 as in the configuration shown in FIG. The electronic circuit component may be, for example, an integrated circuit component such as an LED driver, or a passive circuit component such as a capacitor, resistor, or inductor.

  Moreover, in the vital sensor module 2 according to the first embodiment, the housing 10 can be wearably mounted.

  Further, the PCB 20 may be provided with a flexible material having flexibility according to the shape on the surface of the human or animal body. That is, the substrate may include a flexible printed circuit board.

(Operation method of vital sensor module)
A flowchart showing an operation method of the vital sensor module 2 according to the first embodiment is expressed as shown in FIG.

  As shown in FIG. 10, the operating method of the vital sensor module 2 according to the first embodiment includes a step S1 for turning on the power, a step S2 for starting the measurement by the optical sensor 1, and the mounting state is correct. Step S3 for determining whether or not the mounting state is incorrect in step S3, step S4 for displaying an alert on the display unit (40), resetting the measurement in response to the alert display, and measuring by the optical sensor 1 Step S5 returns to Step S2, and if the mounting state is correct in Step S3, Step S6 continues measurement by the optical sensor 1, and Step S7 stores the measured data in the storage unit (42). And step S8 which complete | finishes measurement, and step S9 which turns off power-on.

  Further, in FIG. 10, a flowchart showing a detailed operation method between step S6 and step S7 is expressed as shown in FIG.

  First, after step S6 in which measurement by the optical sensor 1 is continued, the process proceeds to step S61 in which it is determined whether or not signal acquisition by another sensor is performed. Here, for example, a temperature sensor or a pressure sensor is assumed as the other sensor.

  In step S61, when signal acquisition by another sensor is performed (YES), the process proceeds to step S62, and a signal from another sensor is acquired.

  Next, in step S62, after signal acquisition by another sensor is performed, the process proceeds to step S63, and the acquired signal information is stored in the storage unit (memory) 42.

  Next, in step S63, the acquired signal information is stored in the storage unit (memory) 42, and then the process proceeds to step S64 to acquire a pulse wave signal.

  In step S61, if signal acquisition by another sensor is not performed (NO), the process proceeds to step S64 to acquire a pulse wave signal.

  Next, in step S64, after acquiring the pulse wave signal, the process proceeds to step S7, and the acquired pulse wave signal information (data) is stored in the storage unit (memory) 42.

  Furthermore, after step S7, the operations of step S61, step S62, step S63, and step S64 may be repeated.

(Relationship between pulse wave signal intensity and number of samples S)
The vital sensor module according to the first embodiment includes an LED 12 that emits visible light and / or near-infrared light and a PD 14 having sensitivity in the same band, and can provide a pulse wave sensor module.

  Furthermore, the vital sensor module according to the first embodiment can be formed as a single composite module including a pulse wave sensor / thermistor / acceleration sensor by mounting sensors such as a thermistor / acceleration sensor. The wearing form is attached to the body in a shape (watch / wristband / earphone, etc.) that is in close contact with the body surface such as a fingertip / wrist / ear canal.

(Signal amplitude focus area)
In the vital sensor module according to the first embodiment, a measurement example of the relationship between the pulse wave signal intensity (au) and the number of samples S is expressed as shown in FIG. Further, in the vital sensor module according to the first embodiment, another measurement example of the relationship between the pulse wave signal intensity (au) and the number of samples S is expressed as shown in FIG.

  Here, the sampling is performed 200 times per second, for example. Therefore, the sample number S = 1000 (pieces) on the horizontal axis in FIGS. 12 and 13 corresponds to 5 seconds, and the sample number S = 11000 (pieces) corresponds to 55 seconds. Accordingly, in the two examples shown in FIGS. 12 and 13, the horizontal axis corresponds to sampling for 50 seconds. In addition, when the sampling frequency is relatively low, for example, 20 Hz, the resolution of the obtained pulse wave is lowered, and it becomes difficult to visualize the respiratory rhythm. For this reason, the sampling frequency is desirably in a relatively high frequency range of about 100 Hz to 1 kHz.

  In both the examples shown in FIGS. 12 and 13, the number of breaths during pulse wave measurement is unified at 13 times / minute.

  In the vital sensor module according to the first embodiment, an example of measuring the number of breaths by the envelope of the relationship between the pulse wave signal intensity (au) and the number of samples S in FIG. 12 (number of samples S = 1000 to 6000 (pieces)) ) Is expressed as shown in FIG. In the vital sensor module according to the first embodiment, an example of measuring the number of breaths by the envelope of the relationship between the pulse wave signal intensity (au) and the number of samples S in FIG. 12 (number of samples S = 6000 to 11000 ( )) Is expressed as shown in FIG.

  Here, the sampling is performed 200 times per second, for example. Therefore, the number of samples S = 1000 (pieces) on the horizontal axis in FIG. 14 corresponds to 5 seconds, and the number of samples S = 6000 (pieces) corresponds to 30 seconds. Accordingly, in the example shown in FIG. 14, the horizontal axis corresponds to sampling for 25 seconds.

  Similarly, the number of samples S = 6000 (pieces) on the horizontal axis in FIG. 15 corresponds to 30 seconds, and the number of samples S = 11000 (pieces) corresponds to 55 seconds. Therefore, in the example shown in FIG. 15, the horizontal axis corresponds to sampling for 25 seconds.

  In the vital sensor module according to the first embodiment, an envelope that reflects the respiratory rhythm can be obtained by arranging the peak values of the top and bottom of the waveform of the pulse wave signal intensity (au) in time series. .

  In the vital sensor module according to the first embodiment, as shown in FIGS. 12 to 15, when attention is paid to a change in pulse wave signal intensity (signal amplitude) in a lower region from the baseline AA of the pulse wave, The components appear and it can be seen that changes accompanying breathing appear.

  In the vital sensor module according to the first embodiment, the signal amplitude of the obtained pulse wave undergoes a change in amplitude due to respiration. Therefore, the change in the lower region is particularly monitored from the baseline AA line of the signal amplitude. Thus, the respiratory rhythm can be detected.

(Change in signal amplitude due to apnea)
In the vital sensor module according to the first embodiment, a measurement example (sample number S = 1000 to 8000 (pieces)) of the relationship between the pulse wave signal intensity (au) and the sample number S during apnea is shown in FIG. It is expressed as shown in In the vital sensor module according to the first embodiment, another measurement example of the relationship between the pulse wave signal intensity (au) during apnea and the number of samples S (number of samples S = 1000 to 11000 (pieces)). Is expressed as shown in FIG.

  Here, the sampling is performed 200 times per second, for example. For this reason, in the two examples shown in FIGS. 16 and 17, the horizontal axis corresponds to sampling for 35 seconds and 50 seconds, respectively.

  In both of the examples shown in FIGS. 16 and 17, the number of breaths during pulse wave measurement is unified to zero.

  In the example shown in FIG. 16, the initial value of the signal amplitude of the pulse wave signal intensity (au) at the time of apnea is 1200, whereas after 35 seconds, the signal amplitude of the pulse wave signal intensity (au) is , About 300.

  Similarly, in the example shown in FIG. 17, the initial value of the signal amplitude of the pulse wave signal intensity (au) during apnea is 1000, whereas the pulse wave signal intensity (au) is 50 seconds later. The signal amplitude is reduced to about 600.

By stopping breathing, oxygenated hemoglobin (HbO ₂ ) in the blood is decreased, and the blood oxygen saturation is decreased. Therefore, even when the same amount of blood propagation is performed, the signal amplitude of the pulse wave decreases.

  Therefore, in the vital sensor module according to the first embodiment, it is possible to determine the presence or absence of breathing by measuring a decreasing tendency of the signal amplitude of the pulse wave.

  In general, if apneas of 10 seconds or more are observed 30 times or more in 7 hours, or if the number of apneas or hypopneas is observed 5 times or more in 1 hour, it is determined as apnea Is done.

(Operation method of vital sensor module: flowchart example 1)
Flowchart example 1 showing the operation method of the vital sensor module according to the first embodiment is expressed as shown in FIG. Further, an explanatory diagram of a pulse wave signal waveform corresponding to the operation method shown in FIG. 18 is expressed as shown in FIG.

As shown in FIG. 19, the bottom n-th time of the pulse wave signal waveform is defined as T _n and the bottom n-th signal intensity is defined as B _n .

Hereinafter, an operation flowchart example 1 of the vital sensor module according to the first embodiment will be described.
(A) First, in step S11, a pulse wave is acquired by an optical sensor.
(B) Next, in step S12, the acquired analog signal of the pulse wave is converted into a digital signal via the A / D converter.
(C) Next, in step S13, the bottom of the pulse wave is detected and a time stamp as time information is given. The obtained data is defined as (T _n , B _n ).
(D) Next, in step S14, the time interval D _n (= T _n −T _n−1 ) of each bottom is calculated, and compared with the time intervals (D _n−1 , D _{n + 1} ) before and after, For example, when it is about 50% or about 200% or more, it is excluded as an error value. A value (T _c , B _c ) supplemented from the preceding and succeeding time intervals is substituted for the data excluded as the error value. Here, as the supplemented value, a method of taking a simple average of preceding and succeeding data, a method of taking a weighted average with weighting, or the like can be adopted.
(e) After performing the above processing, in step S15, the moving average processing is appropriately performed on the data group (B ₀ , B ₁ ,..., B _n ,...). A data group after the moving average processing is defined as (b ₀ , b ₁ ,..., B _n ,...).
(F) Next, in step S16, an envelope is obtained by connecting the data (T _n , b _n ) subjected to the moving average process, and a peak or bottom value per unit time is obtained for the obtained envelope. To obtain respiratory rate information.

  If conversation or forced breathing is detected by the microphone during the above operation, the system is notified (flag notification) to that effect.

  Since the information on the respiratory rate obtained during this period may not be correctly detected by conversation or the like, the system side may determine whether or not the information can be used.

(Operation method of vital sensor module: flowchart example 2)
A flowchart example 2 showing another operation method of the vital sensor module according to the first embodiment is expressed as shown in FIG. Further, an explanatory diagram of a pulse wave signal waveform corresponding to the operation method shown in FIG. 20 is expressed as shown in FIG.

As shown in FIG. 21, the peak n-th time of the pulse wave signal waveform is t _n , the peak n-th signal strength is P _n , the bottom n-th time is T _n , and the bottom n-th signal strength is B _n . Defined.

The operation flowchart example 2 of the vital sensor module according to the first embodiment will be described below.
(A) First, in step S21, a pulse wave is acquired by an optical sensor.
(B) Next, in step S22, the acquired analog signal of the pulse wave is converted into a digital signal via the A / D converter.
(C) Next, in step S23, the peak and bottom of the pulse wave are detected, and a time stamp is provided as time information. The obtained peak data is (t _n , P _n ), and the obtained bottom data is (T _n , B _n ).
(D) Next, in step S24, the difference (P _n −B _n ) or (P _n −B _n−1 ) between the peak signal intensity and the bottom signal intensity is calculated and set as the signal amplitude ΔH _n .
(E) Next, in step S25, the signal amplitude ΔH is calculated with the passage of time, and the amount of change in the signal amplitude ΔH is monitored.
(F) Next, in step S26, when the signal amplitude ΔH continuously decreases for a certain time (for example, 15 seconds, 30 seconds, etc.), it is determined that appropriate breathing is not maintained, and the system side To that effect.

  In the vital sensor module according to the first embodiment, a measurement example of the relationship between the pulse wave signal intensity (a.u.) and the number of samples S during the operation of FIG. 20 is shown in FIG. In the example shown in FIG. 22, the signal amplitude continuously decreases from 35 to 35 seconds until the signal amplitude ΔH = 1200 to ΔH = 300.

  An example of a pulse wave signal waveform in the vital sensor module according to the comparative example, and a typical waveform example including the ejection wave P1 and the reflected wave P2 is represented as shown in FIG. An example of a waveform having a notch and an inflection point (false P1) is represented as shown in FIG. 23B, and an example of a waveform having a deformation / amplitude change of a reflected wave at the systolic apex is shown in FIG. A waveform example having an unnatural inflection line of a descending leg is expressed as shown in FIG.

  FIG. 24A is a pattern example of a pulse wave signal waveform requiring attention in a vital sensor module according to a comparative example, and a systolic deformation example (notch type) is represented as shown in FIG. ) Is expressed as shown in FIG. 24 (b), and the diastolic modification (ripple shape) is expressed as shown in FIG. 24 (c).

  Due to the pressing pressure between the measuring instrument and the skin, distortion as shown in FIG. 23 and FIG. 24 occurs in each peak of the pulse wave. In addition, each peak of the pulse wave is affected by the pressing pressure between the measuring instrument and the skin, and a plurality of peaks including false peaks appear. Therefore, when the upper envelope is adopted, the detection accuracy is reduced due to the inclusion of a false peak, but in the vital sensor module according to the first embodiment, focus on the lower envelope rather than the upper envelope. Thus, the respiratory rhythm can be detected.

  Further, in the vital sensor module according to the first embodiment, the data calculation load in the MCU is small, and low power consumption and low cost can be achieved.

  Further, in the vital sensor module according to the first embodiment, since the amplitude change accompanying the occurrence of bradycardia is detected using the lower envelope, the lead time until detection is short, and body motion noise Is easy to distinguish.

  Furthermore, in the vital sensor module according to the first embodiment, it is possible to improve detection accuracy by combining body surface temperature / conversation and information on presence / absence of forced breathing (sampling frequency: low).

  In the vital sensor module according to the first embodiment, depending on the measurement state, referring to sensor output information (body surface temperature / presence of body movement / presence of conversation, etc.) acquired at the same time, The detection accuracy of the respiratory rhythm can be increased.

  Moreover, in the vital sensor module according to the first embodiment, it is possible to monitor the breathing rhythm of the wearer by a simple method without a large wearing load.

  In addition, by using the vital sensor module according to the first embodiment, it is not necessary to go to a specialized institution or the like, and monitoring in an environment close to everyday life is possible.

  Further, by using the vital sensor module according to the first embodiment, it becomes possible to help relaxation and physical condition management by visualizing the respiratory rhythm.

  As described above, according to the first embodiment, respiratory components such as respiratory rhythm, respiratory rate, and respiratory presence / absence can be reduced by reducing the burden caused by the wearing state of the subject and paying attention to changes in the signal amplitude of the pulse wave. Vital sensor module and its operation that can monitor the wearer's condition by acquiring information such as pulse rate, blood oxygen saturation, and presence or absence of body movement. A method can be provided.

[Second Embodiment]
In the vital sensor module 2 according to the second embodiment, a schematic planar configuration viewed from the side in contact with the human body is expressed as shown in FIG.

  In the vital sensor module 2 according to the second embodiment, the sensor includes a pressure sensor that detects a contact pressure with a surface in contact with the body surface when the sensor is attached. That is, by providing a pressure sensor that detects contact pressure (pressing pressure) on a surface (region) that comes into contact with the body (skin) when worn, information regarding the wearing condition may be made explicit to the subject.

As shown in FIG. 25, the vital sensor module 2 according to the second embodiment includes a PCB 20, an LED 12 disposed on the surface of the PCB 20, and a PD 14 _1. 14 _2, 14 _3, 14 _4, on the surface of the PCB 20, the LED12 and PD 14 _1, 14 _2, 14 _3, 14 ₄ pressure is spaced apart from the sensor 22 _1, 22 _2, 22 _3, 22 ₄ The reflected light returning from the living body is received by PDs 14 ₁ , 14 ₂ , 14 ₃ , 14 ₄ , and the intensity of the reflected light is detected. At the same time, the pressure sensors 22 ₁ , 22 ₂ , 22 _3, and 22 ₄ can clearly indicate information on the contact state with the body surface based on the sensor output value detected by contacting the body surface.

Further, as shown in FIG. 25, a black light shielding resin wall 21 is disposed on the surface of the PCB 20, and the LED 12 and the PDs 14 ₁ , 14 ₂ , 14 ₃ , 14 ₄ , pressure sensors 22 ₁ , 22 ₂ are arranged. 22 ₃ and 22 ₄ are separated from each other by the light shielding resin wall 21. An insulating layer colored black may be applied to the light shielding resin wall 21.

  The vital sensor module 2 according to the second embodiment may detect the wavelength, attenuation ratio, or phase difference of the reflected light.

  The sensor can determine the wearing state depending on whether the sensor output value is within the threshold range or outside the threshold range. Other configurations and operation methods are the same as those in the first embodiment.

  According to the second embodiment, similar to the first embodiment, the burden due to the wearing state of the subject is reduced, and the respiratory rhythm, the respiratory rate, and the presence / absence of breathing by focusing on the change in the signal amplitude of the pulse wave Vital sensor that can extract the respiratory components such as pulse rate, blood oxygen saturation, presence / absence of body movement, etc. A module and its operating method can be provided.

[Third embodiment]
In the vital sensor module 2 according to the third embodiment, a schematic planar configuration viewed from the side in contact with the human body is expressed as shown in FIG.

In the vital sensor module 2 according to the third embodiment, as shown in FIG. 26, the sensor is a thermistor 16 ₁ , 16 ₂ , 16 ₃ , 16 ₄ that detects the temperature of the surface in contact with the body surface when worn. And pressure sensors 22 ₁ , 22 ₂ , 22 _3, and 22 ₄ that detect contact pressure with the surface that comes into contact with the body surface when worn.

  The vital sensor module 2 according to the third embodiment is attached to the human body 18 via the strap 50.

As shown in FIG. 26, the schematic planar configuration of the optical sensor portion arranged on the bottom surface side in contact with the human body 18 of the vital sensor module 2 according to the third embodiment is arranged around the LED 12, and the periphery of the LED 12 A plurality of PDs 14 ₁ , 14 ₂ , 14 _3, and 14 ₄ are arranged so as to surround. In the example of FIG. 26, four PDs are arranged.

By arranging a plurality of PDs 14 ₁ , 14 ₂ , 14 _3, and 14 ₄ around the LED 12 so as to surround the periphery of the LED 12, the light information around the LED 12 can be effectively used for the plurality of PDs 14 ₁ , 14 ₂ , 14 _3, and so on. 14 ₄ , and can be applied to a photoelectric pulse wave sensor or the like to improve the operational stability. In addition, since the number of LEDs used is one, low power consumption operation is possible.

Although not shown, an operation unit / display unit and the like are arranged on the top side of the vital sensor module 2 according to the third embodiment so as to be operated and observed by the subject and are in contact with the human body 18. An optical sensor, thermistors 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ , pressure sensors 22 ₁ , 22 ₂ , 22 _3, and 22 ₄ are disposed on the bottom surface side. The optical sensors, thermistors 16 ₁ , 16 ₂ , 16 ₃ , 16 ₄ , and pressure sensors 22 ₁ , 22 ₂ , 22 ₃ , 22 ₄ are arranged on the same PCB arranged on the housing 10. Also good. Or you may arrange | position on a separate board | substrate.

Whether the measured values of the thermistors 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ are within the threshold range or out of the threshold range, the wearing state is determined, and information on the wearing condition is made explicit to the subject. Also good.

The thermistors 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ are also applicable to the measurement of the temperature of the human body 18 or the surface of the animal body.

In addition, the wearing state is determined based on whether the measured values of the pressure sensors 22 ₁ , 22 ₂ , 22 _3, and 22 ₄ are within the threshold range or out of the threshold range, and information on the wearing condition is clearly shown to the subject. You may do it. Other configurations and operation methods are the same as those in the first embodiment or the second embodiment.

  According to the third embodiment, similarly to the first embodiment, the burden due to the wearing state of the subject is reduced, and the respiratory rhythm, the respiratory rate, and the presence / absence of breathing by focusing on the change in the signal amplitude of the pulse wave Vital sensor that can extract the respiratory components such as pulse rate, blood oxygen saturation, presence / absence of body movement, etc. A module and its operating method can be provided.

(Fourth embodiment)
In the vital sensor module 2 according to the fourth embodiment, a schematic planar configuration viewed from the side in contact with the human body is expressed as shown in FIG.

In the vital sensor module 2 according to the fourth embodiment, as shown in FIG. 27, the sensor is a thermistor 16 ₁ , 16 ₂ , 16 ₃ , 16 ₄ that detects the temperature of the surface in contact with the body surface when the sensor is attached. And pressure sensors 22 ₁ , 22 ₂ , 22 _3, and 22 ₄ that detect contact pressure with the surface that comes into contact with the body surface when worn.

  The vital sensor module 2 according to the fourth embodiment is attached to the human body 18 via the strap 50.

As shown in FIG. 27, the schematic planar configuration of the optical sensor portion arranged on the bottom surface side in contact with the human body 18 of the vital sensor module 2 according to the fourth embodiment is arranged around the PD 14 and the periphery of the PD 14 A plurality of LEDs 12 ₁ , 12 ₂ , 12 ₃ , 12 ₄ are arranged so as to surround. In the example of FIG. 27, four LEDs are arranged.

By arranging a plurality of LEDs 12 ₁ , 12 ₂ , 12 _3, and 12 ₄ so as to surround the periphery of the PD 14, it is possible to compensate for the insufficient light quantity of the PD 14 and to irradiate the PD 14 with the same amount of light from the periphery. it can. Therefore, it can be applied to a photoelectric pulse wave sensor or the like to improve the operation stability.

Although not shown, an operation unit / display unit and the like are arranged on the top surface side of the vital sensor module 2 according to the fourth embodiment so as to be operated and observed by the subject and are in contact with the human body 18. An optical sensor, thermistors 16 ₁ , 16 ₂ , 16 ₃ , 16 ₄ , pressure sensors 22 ₁ , 22 ₂ , 22 ₃ , 22 _4, etc. are arranged on the bottom side. The optical sensors, thermistors 16 ₁ , 16 ₂ , 16 ₃ , 16 ₄ , and pressure sensors 22 ₁ , 22 ₂ , 22 ₃ , 22 ₄ are arranged on the same PCB arranged on the housing 10. Also good. Or you may arrange | position on a separate board | substrate.

Whether the measured values of the thermistors 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ are within the threshold range or out of the threshold range, the wearing state is determined, and information on the wearing condition is made explicit to the subject. Also good.

The thermistors 16 ₁ , 16 ₂ , 16 _3, and 16 ₄ can also be applied to the measurement of the temperature of the human body 18 or the surface of the animal body.

In addition, the wearing state is determined based on whether the measured values of the pressure sensors 22 ₁ , 22 ₂ , 22 _3, and 22 ₄ are within the threshold range or out of the threshold range, and information on the wearing condition is clearly shown to the subject. You may do it. Other configurations and operation methods are the same as those in the first to third embodiments.

  According to the fourth embodiment, similarly to the first embodiment, the burden due to the wearing state of the subject is reduced, and the respiratory rhythm, the respiratory rate, the presence / absence of breathing by focusing on the change in the signal amplitude of the pulse wave Vital sensor that can extract the respiratory components such as pulse rate, blood oxygen saturation, presence / absence of body movement, etc. A module and its operating method can be provided.

(Fifth embodiment)
A bird's-eye view of the optical sensor portion 2A of the vital sensor module 2 according to the fifth embodiment is represented as shown in FIG. 28 (a), and an explanatory diagram of FIG. 28 (a) is shown in FIG. 28 (b). It is expressed as follows.

  A bird's-eye view of the vital sensor module 2 according to the fifth embodiment is represented as shown in FIG. 29 (a), and an explanatory diagram of FIG. 29 (a) is represented as shown in FIG. 29 (b). .

  28 and 29, the optical sensor 1 is projected from the surface of the module housing 10 by about 1 mm to 2 mm. A power switch (SW) 102 is disposed on the side surface of the module housing 10. The power can be supplied from the outside via the micro USB terminal 110, for example. Further, as a power source, a solar cell, a dye-sensitized solar cell, an organic thin film solar cell, or the like may be built-in and made wireless. Further, similarly to the vital sensor module 2 according to the first embodiment, a configuration capable of performing wireless communication with an external PC / mobile terminal may be employed.

  29, for example, the length L is about 35 mm, the width W is about 25 mm, and the thickness D is about 13 mm. The above dimensions are examples, and as described in the mounting example of the vital sensor module according to the embodiment, the dimensions are appropriately sized according to the mounting state on the forearm, the index finger, the ear canal entrance, or other human body parts. May be miniaturized.

  In order to determine the mounting state, various sensors can be arranged in the sensor arrangement portions SR1 and SR2 around the optical sensor 1 on the surface of the module housing 10. The various sensors can be arranged with a thermistor, an interelectrode resistance sensor, a pressure sensor, and the like.

  In order to stably determine the mounting state by measuring temperature, pressure, resistance value, etc., it is desirable to arrange two or more measurement points. That is, a plurality of thermistors may be arranged and the data at a plurality of measurement points may be compared. In the case of an inter-electrode resistance sensor, it is preferable to arrange a plurality of electrodes, measure the resistance value between the plurality of electrodes, and compare the data. If it is a pressure sensor, it is good to arrange a plurality and to compare the data of a plurality of measurement points.

  The measurement unit of the vital sensor module according to the fifth embodiment is not limited to the watch type because it is assumed that the measurement unit is other than the wrist and the forearm. As described in the mounting example of the vital sensor module according to the embodiment, it may be mounted on the index finger / ear canal entrance or other human body part.

  In addition, on the bottom surface side of the vital sensor module 2 according to the fifth embodiment (in the usage state, the top surface side), an operation unit, a display unit, and the like are arranged so that the subject can perform operations and observations. In addition, the optical sensor 1, various sensors, and the like are arranged on the surface side that is in contact with the human body 18 (the surface that contacts the human body when in use).

(Schematic block configuration of vital sensor module)
A schematic block configuration of the vital sensor module 2 according to the fifth embodiment is expressed as shown in FIG.

  As shown in FIG. 30, the vital sensor module 2 according to the fifth embodiment includes a power supply unit 34, a control unit 30 connected to the power supply unit 34, and an optical sensor that detects optical information of the external living body 18. 1 and a sensor (temperature sensor 38 / various sensors 43) for detecting contact information with the living body 18, a display unit 40 for displaying mounting information with the living body 18, and the optical sensor 1 and the sensors (38/43). And a storage unit 42 for storing the processed data.

  As shown in FIG. 30, the vital sensor module 2 according to the fifth embodiment may include a temperature sensor 38 that detects the temperature of the living body 18.

  As shown in FIG. 30, the vital sensor module 2 according to the fifth embodiment may include a pressure sensor as various sensors 43 that detect contact information with the living body 18.

  As shown in FIG. 30, the vital sensor module 2 according to the fifth embodiment includes a wireless communication unit 32 and an antenna 36 for wirelessly communicating mounting information with the living body 18, and includes an external PC / portable terminal 4. Wireless communication can be carried out with

  As shown in FIG. 30, the vital sensor module 2 according to the fifth embodiment includes a speaker 47 that clearly indicates wearing information with the living body 18, an external interface 33 that can be connected to an external device, and an operation that performs an operation. The unit 35 and a microphone 37 for inputting voice information may be provided. Here, as an external device connected to the external interface (I / F) 33, a charging device or the like may be provided. Here, as a charging method, for example, a method of supplying from the outside via the micro USB terminal 110 or a method of supplying power wirelessly from the outside through a minute coil may be applied. In addition, a solar cell, a dye-sensitized solar cell, an organic thin film solar cell, or the like may be incorporated to reduce the size and wirelessly.

  Other configurations and operation methods are the same as those in the first to fourth embodiments.

(Circuit block configuration of vital sensor module)
The circuit block configuration of the vital sensor module according to the fifth embodiment is expressed as shown in FIG.

  The LED / PD in the optical sensor 1 is connected to the MCU 30 via an LED driver 1D / analog front end (AFE) 1A.

  The thermistor 38 is connected to the MCU 30 via an amplifier and an A / D converter 38A.

  The microphone 37 is connected to the MCU 30 via an amplifier and an A / D converter 37A.

  Further, the MCU 30 may be connected to the acceleration sensor 43 as various sensors, for example, so as to be able to detect the movement of the body.

  The MCU 30 may be connected to a wireless communication unit (RF) 32.

  Further, the MCU 30 may be connected to the speaker 47 via a D / A converter and an amplifier 47A.

  Further, the MCU 30 may be connected to the display 40 and the memory 42.

  According to the fifth embodiment, as in the first embodiment, the burden due to the wearing state of the subject is reduced, and the respiratory rhythm, the respiratory rate, and the presence / absence of breathing by focusing on the signal amplitude change of the pulse wave Vital sensor that can extract the respiratory components such as pulse rate, blood oxygen saturation, presence / absence of body movement, etc. A module and its operating method can be provided.

(Operation method of vital sensor module: optical sensor calibration)
A flowchart showing the operation methods of the vital sensor modules according to the first to fifth embodiments is expressed as shown in FIG.

  As shown in FIG. 32, the operating method of the vital sensor module according to the first to fifth embodiments includes a mounting state determination step S31 and a step S32 for determining whether or not the measured value of the sensor is within a threshold range. If the measured value of the sensor is not within the threshold range in step S32 to be determined, an alert is displayed and the measured value of the sensor is returned in step S33 to return to the mounting state determination step and in step S32 to be determined above. Is within the threshold range, step S34 for performing optical sensor calibration, step S35 for measuring by the optical sensor, step S36 for determining whether the measurement by the optical sensor is completed, If the measurement is not completed, the step returns to step S35 of measuring by the optical sensor, and the optical sensor If by measurement is completed, and a step of ending.

  Here, a thermistor, a pressure sensor, an interelectrode resistance sensor, or the like can be applied to the sensor. For example, when a plurality of thermistors are arranged, the output value of each thermistor is monitored. If even one of the thermistors falls outside the threshold range, the determination result can be NO in step S32.

  As the alert display in step S33, for example, blinking display by LED or display display can be applied.

  “Optical sensor calibration” is defined as follows.

  Since the detection sensitivity of the pulse wave varies depending on the person and the measurement unit, in order to obtain a substantially constant output (pulse wave amplitude), it is necessary to change the amount of LED light depending on the person and the measurement unit. . Therefore, by monitoring the output (pulse wave amplitude) when the LED light amount is changed from a relatively low state to a relatively high state, the initial setting for determining the optimal LED light amount for the subject is light. This is called sensor calibration.

  A flowchart showing another operation method of the vital sensor module according to the first to fifth embodiments is expressed as shown in FIG.

  As shown in FIG. 33, another operation method of the vital sensor module according to the first to fifth embodiments includes a mounting state determination step S41 and a step of determining whether or not the measured value of the thermistor is within a threshold range. If the measured value of the thermistor is not within the threshold range in S42 and the above-described determination step S42, an alert is displayed, and the process returns to the mounting state determination step S43, and in the above determination step S42, the thermistor If the measured value is within the threshold range, step S44 for performing optical sensor calibration, step S45 for measuring pulse waves with the optical sensor, step S46 for measuring temperature with the thermistor, and temperature measurement with the thermistor. Step S47 for determining whether or not the result is less than the threshold value continuously for a predetermined time; When the temperature measurement result by the star is less than the threshold value for a predetermined time continuously, an alert is displayed, and the step S43 for returning to the mounting state determination step S41 and the temperature measurement result by the thermistor are continuous for the predetermined time. If it is not less than the threshold, step S48 determines whether or not the pulse wave measurement by the optical sensor is completed. If the pulse wave measurement by the optical sensor is not completed, the pulse wave is measured by the optical sensor. The process returns to step S45, and if the pulse wave measurement by the optical sensor has been completed, the process has a step of ending.

  As the alert display in step S43, for example, blinking display by LED or display display can be applied.

(Examples of various pressure sensors)
―Button type pressure sensor―
A button-type pressure sensor can be applied as the pressure sensor 22 applicable to the vital sensor module 2 according to the embodiment. In the vital sensor module 2 according to the embodiment to which the button type pressure sensor is applied, the mounting state can be determined depending on whether the output value of the button type pressure sensor is within the threshold range or outside the threshold range.

-Air blow type pressure sensor-
As the pressure sensor 22 applicable to the vital sensor module 2 according to the embodiment, an air blowing pressure sensor can be applied. In the vital sensor module 2 according to the embodiment to which the air blowing type pressure sensor is applied, the mounting state is determined depending on whether the output value of the air blowing type pressure sensor is within the threshold range or outside the threshold range. it can. For example, the mounting state may be determined to be poor in the pressure release state and the mounting state may be determined to be good in the pressure application state based on the air pressure of the air blowing port. Alternatively, the contact pressure may be derived by detecting the air resistance at the air outlet that sends out air.

―Film pressure sensor―
As the pressure sensor 22 applicable to the vital sensor module 2 according to the embodiment, a film-like pressure sensor can be applied. In the vital sensor module 2 according to the embodiment to which the film-like pressure sensor is applied, the mounting state can be determined depending on whether the output value of the film-like pressure sensor is within the threshold range or outside the threshold range. As the film-shaped pressure sensor, for example, a film-shaped piezo film pressure sensor can be applied, and processing such as color development in a pressurized region may be performed.

―O-ring resistance film type pressure sensor―
As the pressure sensor 22 applicable to the vital sensor module 2 according to the embodiment, an O-ring resistance film type pressure sensor can be applied. The O-ring resistance film type pressure sensor applicable to the vital sensor module 2 according to the embodiment is disposed on the glass substrate, the first transparent electrode layer disposed on the glass substrate, and the first transparent electrode layer. Dot spacers, a second transparent electrode layer disposed on the first transparent electrode layer via a dot spacer and a space, and an insulating layer disposed on the second transparent electrode layer. The insulating layer can be formed of, for example, polyethylene terephthalate (PET).

  The O-ring resistance film type pressure sensor applies a resistance film type touch panel, when pressure is applied to the insulating layer, the insulating layer and the second transparent electrode layer are pushed down, and the first and second transparent electrode layers come into contact with each other. The contact point coordinates can be detected.

-O-ring pressure sensor-
Further, as the pressure sensor 22 applicable to the vital sensor module 2 according to the embodiment, an O-ring-shaped pressure sensor is an O-ring-shaped tube in which a liquid / gas / laser light source is enclosed, and a liquid / gas. The contact pressure may be derived by detecting the flow of light and the intensity of the laser beam.

(Example of resistance sensor between electrodes)
The contact resistance between the electrodes is expressed by a parallel circuit of the resistance R _S of the skin portion and the resistance R _W of the surface portion in the contact state with the human body 18, and is usually about 2 kΩ to 5 kΩ. On the other hand, in a non-contact state with the human body 18, it is about several MΩ.

  The vital sensor module 2 according to the embodiment may include an inter-electrode resistance sensor that comes into contact with the body surface when it is mounted.

  The optical sensor, thermistor, and pressure sensor may be disposed on the same PCB disposed on the housing 10. Or you may arrange | position on a separate board | substrate.

  As in the third or fourth embodiment, a thermistor or a pressure sensor may be provided and used in combination with these sensors.

  The vital sensor module 2 according to the embodiment is attached to the human body 18 via the strap 50.

  A black light shielding resin wall is disposed on the surface of the PCB 20, and the LED and PD / electrode resistance sensor are separated from each other by the light shielding resin wall. An insulating layer colored black may be applied to the light shielding resin wall.

  Depending on whether the measured value of the interelectrode resistance sensor is within the threshold range or outside the threshold range, the wearing state may be determined, and information regarding the wearing state may be made explicit to the subject.

  In the vital sensor module 2 according to the embodiment, the mounting state can be determined depending on whether the output value of the interelectrode resistance sensor is within the threshold range or outside the threshold range.

  For example, the contact resistance between the electrodes is normally about 2 kΩ to 5 kΩ in the contact state with the human body, so if it is within this range, it is determined to be within the threshold range, and about several MΩ in the non-contact state with the human body. Therefore, if it is within this range, it can be determined that it is outside the threshold range.

  The vital sensor module according to the present embodiment includes a sleep breathing monitor tool, a rehabilitation monitor tool for sick patients (determining whether rehabilitation is overloaded from the respiratory state), a relaxation tool (which manages respiratory rate) It can be used for medical measurement equipment such as abdominal breathing, respiration monitor, activity meter, and heart rate monitor.

  As described above, according to the present embodiment, it is possible to extract respiratory components such as respiratory rhythm, respiratory rate, and respiratory presence / absence by reducing the burden due to the wearing state of the subject and paying attention to the change in the signal amplitude of the pulse wave. A vital sensor module that can monitor the wearer's condition by acquiring information such as pulse rate, blood oxygen saturation, and presence / absence of body movement, and its operation method. Can be provided.

[Other embodiments]
As described above, the present embodiment has been described. However, it should be understood that the description and the drawings, which form a part of this disclosure, are illustrative and do not limit the present embodiment. From this disclosure, various alternative embodiments, examples and operational techniques will be apparent to those skilled in the art.

  As described above, this embodiment includes various embodiments not described here.

  The vital sensor module of the present embodiment can be applied to medical measurement devices such as a rehabilitation monitor tool after medical treatment, a living body monitor tool during sleep, an activity meter, and a heart rate monitor.

1 ... optical sensor 2,2F, 2E ... vital sensor module 4 ... PC / portable terminal 8A ... memory 8B ... control integrated circuit 8C ... capacitor 8R ... resistance element 9 ... Battery 10 ... module housing 12, 12 _1, 12 ₂ , 12 ₃ , 12 ₄ ... Light emitting element (LED)
14, 14 ₁ , 14 ₂ , 14 ₃ , 14 ₄ ... Light receiving element (PD)
16, 16 ₁ , 16 ₂ , 16 ₃ , 16 ₄ ... thermistor 18 ... human body (living body) (forearm)
18F ... Index finger 20, 20A, 20B ... Printed circuit board (PCB, board)
21 ... Light shielding resin wall (insulating layer)
21B ... Columnar resin wall (insulating wall)
22, 22 ₁ , 22 ₂ , 22 ₃ , 22 ₄ ... pressure sensor 30 ... control unit (MCU)
32 ... Wireless communication unit (RF)
33 ... External interface (I / F)
34 ... Power supply unit 35 ... Operation unit 36 ... Antenna 37 ... Microphones 37A, 38A ... Amplifier and A / D converter 38 ... Temperature sensor (thermistor)
40. Display section (display)
42 ... Storage unit (memory)
43 ... Various sensors (acceleration sensor)
47 ... Speaker 47A ... D / A converter and amplifier 50, 50F ... Strap 100 ... Vital sensor module 102 ... Power switch (SW)
110 ... Micro USB terminal (receptacle)
SR ₁ , SR ₂ ... sensor placement section

Claims (20)

A substrate,
A light emitting device disposed on a surface of the substrate;
A light receiving element disposed on the surface and spaced apart from the light emitting element;
The light received by the light receiving element is contacted with the body surface of the living body, and the light emitted from the light emitting element returns from the living body, and the pulse wave signal intensity is detected based on the intensity of the reflected light.
A vital sensor module characterized in that an envelope reflecting a respiratory rhythm is obtained by arranging the peak values of the top and bottom of the waveform of the pulse wave signal intensity in time series.   The vital sensor module according to claim 1, wherein the number of breaths can be measured by an envelope of a relationship between the pulse wave signal intensity and the number of samples within a predetermined time.   The vital sensor module according to claim 1 or 2, wherein a respiratory rhythm can be detected by monitoring a change in signal amplitude in a region below a predetermined baseline of the pulse wave signal intensity.   The vital sensor module according to claim 1, wherein the presence or absence of respiration can be determined by measuring a decreasing tendency of the signal amplitude of the pulse wave signal intensity.   The vital sensor module according to claim 1, further comprising a sensor disposed on the surface so as to be separated from the light emitting element and the light receiving element.   The vital sensor module according to claim 5, wherein the sensor is capable of clearly indicating information related to a contact state with the body surface based on a sensor output value detected by contacting the body surface.   The vital sensor module according to claim 6, wherein the sensor determines a mounting state based on whether the sensor output value is within a threshold range or outside the threshold range.   The vital sensor module according to claim 5, wherein the sensor includes a pressure sensor that detects a contact pressure with a surface that contacts the body surface when the sensor is attached.   The sensor includes a thermistor that detects a temperature of a surface in contact with the body surface when worn, and determines a wearing state depending on whether the measured value of the thermistor is within a threshold range or outside the threshold range. The vital sensor module according to any one of claims 5 to 7.   The vital sensor module according to claim 9, wherein the thermistor is applicable to the measurement of the temperature of the body surface of the living body.   The vital sensor module according to claim 1, wherein the substrate includes a flexible material having flexibility.   The vital sensor module according to claim 11, wherein the substrate includes a flexible printed circuit board.   The vital sensor module according to claim 1, wherein the light emitting element includes a light emitting diode.   The vital sensor module according to claim 1, wherein the light emitting element includes a red light emitting diode and an infrared light emitting diode, and is capable of measuring blood oxygen saturation.   The vital sensor module according to any one of claims 1 to 14, wherein the vital sensor module can be attached to a forearm, a finger, or an external auditory canal of a human body.   The vital sensor module according to claim 1, wherein the vital sensor module is capable of wireless communication with an external personal computer or a portable terminal. Obtaining a pulse wave signal waveform by an optical sensor;
A / D converting the pulse wave signal waveform;
Detecting the bottom of the pulse wave signal waveform, setting the bottom n-th time of the pulse wave signal waveform to T _n , the bottom n-th signal intensity as B _n , and setting the data to (T _n , B _n ) When,
When the time interval D _n (= T _n −T _n−1 ) of each bottom is calculated and becomes 50% or 200% or more compared to the time interval (D _n−1 , D _{n + 1} ) before and after Are excluded as error values, and substituting values (T _c , B _c ) supplemented from previous and subsequent time intervals for the data excluded as error values;
The data group (B ₀ , B ₁ ,..., B _n ,...) Is appropriately subjected to moving average processing, and the data group after the moving average processing is expressed as (b ₀ , b ₁ ,..., B _n ,. And steps to
By connecting each data (T _n , b _n ) that has been subjected to moving average processing, an envelope is obtained, and by obtaining a peak value or a bottom value per unit time for the obtained envelope, A method for operating the vital sensor module, comprising: obtaining information.   The method of operating a vital sensor module according to claim 17, wherein the complemented value is obtained by a simple average or a weighted average of preceding and succeeding data. Obtaining a pulse wave signal waveform by an optical sensor;
A / D converting the pulse wave signal waveform;
The peak and bottom of the pulse wave signal waveform are detected, the peak n-th time of the pulse wave signal waveform is t _n , the peak n-th signal intensity is P _n , the bottom n-th time is T _n , and the bottom n A step in which the second signal intensity is B _n , the peak data is (t _n , P _n ), and the bottom data is (T _n , B _n );
Calculating a difference (P _n −B _n ) or (P _n −B _n−1 ) between the peak signal intensity and the bottom signal intensity and setting it as a signal amplitude ΔH _n ;
Calculating the signal amplitude ΔH with the passage of time, and monitoring the amount of change in the signal amplitude ΔH.   20. The method of operating a vital sensor module according to claim 19, further comprising the step of determining that proper respiration is not maintained when the signal amplitude [Delta] H continuously decreases during a certain period of time.