JP7681319B2 - Biological information measuring device - Google Patents

Description

This disclosure relates to a biometric information measuring device for measuring the biometric information of a subject.

Continuously measuring blood pressure and detecting changes in the blood pressure to detect illnesses early or to detect changes in the condition is an effective way of managing health. Therefore, a bioinformation measuring device has been proposed that can continuously measure bioinformation such as blood pressure without applying pressure to the arm with a cuff or the like.

For example, Patent Document 1 illustrates a wrist-worn wearable device that includes an optical sensor module and a motion sensor and is capable of measuring a subject's biometric information, such as heart rate, stress, and blood oxygen saturation, based on reflected light detected by the optical sensor module, and shows a mounting configuration in which the device is worn on the wrist with a belt-type strap.

JP 2019-042500 A

However, conventional wristwatches, such as those illustrated in Patent Document 1, are worn on the wrist with a strap, making them difficult to wear in cases where the user has paralysis in the hand, for example. Therefore, there is a demand for information measuring devices that can be easily worn.

On the other hand, one idea to make the information measuring device easier to wear is to make it a bracelet type (even Patent Document 1 only mentions the term "bracelet type"). In the case of such a bracelet type, it is necessary to create a gap between the attachment point and the measuring device to make it easier to put the wrist through the bracelet, so the desired configuration is in conflict with a configuration that obtains measurement information by being in close contact with the wrist, such as an optical sensor module, and a more complex mechanism would be required to achieve both.

Therefore, the present invention aims to provide a bioinformation measuring device that can accommodate subjects with a variety of arm sizes and can improve the detection accuracy of electrocardiogram waveforms.

In order to solve the above problems, the bioinformation measuring device of the present invention is a bioinformation measuring device having at least a main body portion, the main body portion including a first arm portion and a second arm portion that curve and extend to the left and right from the upper portion to the lower portion of the main body portion, the ends of the first arm portion and the second arm portion are separated from each other, and at least one of the ends of the first arm portion and the second arm portion is provided with an electrode for measuring bioinformation.

The above-mentioned bioinformation measuring device can accommodate subjects with a variety of arm sizes, and can provide a bioinformation measuring device that can improve the detection accuracy of electrocardiogram waveforms.

1 is a diagram for explaining the left arm of a subject, a biological information measuring device, and electrodes at measurement sites according to this embodiment. FIG. 1 is a perspective view of a biological information measuring device according to an embodiment of the present invention. 1A to 1C are six views of a biological information measuring device according to an embodiment of the present invention. 10 is a diagram showing a configuration example in which a thermistor is connected to an electrode of the biological information measuring device according to the present embodiment. FIG. 1 is a schematic block diagram showing a configuration of a biological information measuring system according to an embodiment of the present invention. 4A to 4C are diagrams for explaining examples of an electrocardiogram waveform and a pulse wave according to the present embodiment. 5 is a flowchart for explaining the operation of the blood pressure information measurement system according to the present embodiment.

The contents of the embodiments of the present invention will be listed and described below. A biological information measuring device according to an embodiment of the present invention has the following configuration.
[Item 1]
A biological information measuring device having at least a main body,
The main body includes a first arm and a second arm that are curved and extend to the left and right from an upper portion to a lower portion of the main body,
the ends of the first arm and the second arm are separated from each other;
At least one of the first arm portion and the second arm portion is provided at an end side with an electrode for measuring biological information.
A biological information measuring device comprising:
[Item 2]
At least one of the first arm portion and the second arm portion extends outward in the front-rear direction at a lower portion of the main body portion,
2. The biological information measuring device according to claim 1.
[Item 3]
At least a portion of both ends of the first arm portion and the second arm portion extend to a length such that they overlap each other in the front-rear direction at the lower portion of the main body portion.
3. The biological information measuring device according to claim 2.
[Item 4]
At least one of the ends of the first arm portion and the second arm portion is further curved from the lower side of the main body portion toward the upper side of the main body portion.
4. The biological information measuring device according to claim 1,
[Item 5]
The material of the first arm portion and the second arm portion includes a thermoplastic elastomer.
5. The biological information measuring device according to claim 1,
[Item 6]
The thermoplastic elastomer contains at least a polyether block amide.
6. The biological information measuring device according to claim 5.
[Item 7]
The main body does not have a display unit.
7. The biological information measuring device according to claim 1,
[Item 8]
The two electrodes are provided on the same end side of the first arm portion and the second arm portion.
7. The biological information measuring device according to claim 1,
[Item 9]
The electrode is provided on each of different end sides of the first arm portion and the second arm portion,
7. The biological information measuring device according to claim 1,
[Item 10]
Two of the electrodes are provided on different end sides of the first arm portion and the second arm portion.
7. The biological information measuring device according to claim 1,
[Item 11]
An amplifier is provided to amplify the potential difference between the two electrodes provided on the same end side.
11. The biological information measuring device according to claim 1,
[Item 12]
the main body has a reference voltage terminal for acquiring a reference voltage at an upper portion of the main body, and inputs the reference voltage to the amplifier;
12. The biological information measuring device according to claim 11.
[Item 13]
The reference voltage terminal is connected to a thermistor for measuring the skin temperature of the subject.
13. The biological information measuring device according to claim 12.
[Item 14]
The main body includes an optical sensor module for measuring a pulse wave of a subject.
14. The biological information measuring device according to claim 1,
[Item 15]
The main body includes a communication unit that outputs the measured biological information to an outside.
15. The biological information measuring device according to claim 1,

The present embodiment will be described below. Note that the present embodiment described below does not unduly limit the contents of the present invention described in the claims. Furthermore, not all of the configurations described in the present embodiment are necessarily essential components of the present invention. Furthermore, the features shown in each embodiment can be applied to other embodiments as long as they are not mutually inconsistent.

<Configuration>
The biological information measuring device 100 and the arm of the subject, which is the measurement site, in this embodiment will be described with reference to Figs. 1-3. Fig. 1A shows the biological information measuring device 100 attached to the left arm of the subject. Fig. 1B shows the radial artery and ulnar artery of the subject's left arm in a perspective view, and is a diagram showing the positional relationship between the radial artery, the ulnar artery, and the electrodes of the biological information measuring device 100. Fig. 1C is a diagram showing the positional relationship between the subject's arm, the electrodes of the biological information measuring device 100, and the optical sensor. Fig. 2 is a perspective view of the biological information measuring device 100. Fig. 3 is a six-sided view of the biological information measuring device 100. In Fig. 2, the direction in which the arm of the biological information measuring device 100 is inserted is defined as the front-rear direction, the direction toward the upper surface portion 102 and the opposite direction to the arm are defined as the up-down direction, and the direction in which the first arm portion 131 and the second arm portion 132 extend from the upper portion of the main body portion 101 are defined as the left-right direction for the sake of convenience.

As shown in Figure 1-3, the bioinformation measuring device 100 comprises a main body 101 and an upper surface 102. The main body 101 includes a first arm 131 and a second arm 132 that each curve and extend from the upper part of the main body 101 on the back of the hand to the lower part of the main body 101 so as to follow the wrist of the person being measured. The ends of the first arm 131 and the second arm 132 are separated from each other and have a non-annular shape as a component (i.e., nothing prevents the surfaces of both ends of the first arm 131 and the second arm 132, which are separated from each other, from coming into contact with each other to form a shape that can be called annular). At least one of the ends of the first arm 131 and the second arm 132 (both ends in Figs. 2 and 3) may extend outwardly in the front-rear direction at the lower part of the main body 101, and as shown in the lower view of Fig. 3, at least a part of both ends of the first arm 131 and the second arm 132 may extend to such a length that they overlap each other in the front-rear direction. Furthermore, at least one of the ends of the first arm 131 and the second arm 132 (the end of the first arm 131 in Figs. 2 and 3) may be curved inward (from the lower side of the main body 101 to the upper side of the main body 101), which is the side of the inserted arm. The material of part or all of the material constituting the bioinformation measuring device 100 (particularly the material of the first arm 131 and the second arm 132) is not particularly limited, but is preferably a thermoplastic elastomer having elasticity and excellent processability, and is particularly preferably polyether block amide (PEBA). For example, at least a portion of at least any of the main body 101, the top surface 102, the first arm 131, and the second arm 132 may be produced by a molding process using the above-mentioned materials, and the components produced in this manner may be connected to each other to form the bioinformation measuring device 100.

With this configuration, when the subject's arm is inserted between the first arm 131 and the second arm 132 of the main body 101, the first arm 131 and the second arm 132 are elastically deformed and expanded at least in the left-right direction, making it possible to accommodate various arm sizes with one size, and it is also possible to configure it so that fasteners (fixing devices) such as belts and hook-and-loop fasteners are not required, making it easy to wear even if the hand is paralyzed. In addition, since the ends of the first arm 131 and the second arm 132 are shifted outward in the front-to-back direction and extend to a length that overlaps each other in the front-to-back direction, it is possible to obtain a sufficient length compared to a circular shape like a bracelet, so that even when a thick arm is inserted into the bioinformation measuring device 100, each electrode (described later) provided on the end side of the first arm 131 and the second arm 132 can be positioned near the artery without being too far away from the artery. Furthermore, because the ends of the first arm 131 and the second arm 132 are curved inward (from the lower side of the main body 101 to the upper side of the main body 101), which is the side of the arm that is inserted, the structure is such that even if the first arm 131 and the second arm 132 are elastically deformed at least in the left-right direction and spread out, they can easily catch on the subject's arm, and each electrode provided on the end side of the first arm 131 and the second arm 132 can be sufficiently contacted with the surface of the arm.

The top surface 102 is provided on the outside of the upper part of the main body 101, and may serve as a lid when a circuit board, a battery, etc. are stored inside the main body 101. The top surface 102 may also have a display function, for example, a time display function or a biological information display function. However, if the top surface 102 has a display function, the number of necessary components increases and the main body 101 becomes large, so if miniaturization is required, it is more preferable not to have a display function. In that case, if the subject wants to check his or her biological information, the biological information measuring device 100 may communicate with an external terminal device 200 (see FIG. 5) and the biological information may be displayed on the terminal device display unit 214 of the terminal device 200.

The main body 101 has a first electrode 121 and a second electrode 122 on the end side of the second arm 132, a third electrode 123 and a fourth electrode 124 on the end side of the first arm 131, and includes a fifth electrode 125, a sixth electrode 126, an optical sensor module 111, etc. on the upper inside part of the main body 101. The sixth electrode 126 may be provided, for example, as a terminal for charging the battery, or as a terminal for communication with an external device, or may serve both purposes, or may be provided for other purposes.

As shown in FIG. 1B, the radial artery 911 and the ulnar artery 912 run through the subject's arm. The radial artery 911 runs between the radius and the skin on the surface of the wrist, and the ulnar artery 912 runs between the ulna and the skin on the surface of the wrist. The radial artery 911 and the ulnar artery 912 branch off from the brachial artery (not shown) in the upper arm.

1(B), 2, and 3, the first electrode 121 and the second electrode 122 are arranged side by side in the circumferential direction of the wrist near the radial artery 911 on the palm side of the wrist, and detect an electric potential linked to the electrocardiogram from the radial artery 911. The third electrode 123 and the fourth electrode 124 are arranged side by side in the circumferential direction of the wrist near the ulnar artery 912 on the palm side of the wrist, and detect an electric potential linked to the electrocardiogram from the ulnar artery 912. As shown in FIG. 1(C), 2, and 3, the fifth electrode 125 is arranged on the back side of the wrist, and detects a bioreference electric potential. With this configuration, the fifth electrode 125 is used as a reference potential, and the potential detected by at least one of the first electrode 121 or the second electrode 122, or at least one of the third electrode 123 or the fourth electrode 124 is measured over time by an amplifier (e.g., an operational amplifier, etc.), thereby obtaining an accurate electrocardiogram and measuring the electrocardiogram waveform. In addition, the fifth electrode 125 may be at, for example, ground potential, and by using this, the deviation of the reference potential for measurement can be suppressed, thereby improving the detection accuracy of the electrocardiogram waveform with minute changes (inflection points) such as T waves detected by at least one of the first to fourth electrodes.

Here, the number of electrodes used to obtain an electrocardiogram is not limited to five as described above, and may be increased or decreased as necessary. In this regard, modified examples of electrodes are described below.

<Electrode Modification Example 1>
For example, if an electrocardiogram waveform including minute changes (inflection points) such as T waves can be sufficiently detected from at least one of the first electrode 121 to the fourth electrode 124, the configuration does not need to include the fifth electrode 125.

<Electrode Modifications 2 and 3>
As long as the first electrode 121 to the fourth electrode 124 can be appropriately positioned near either the radial artery 911 or the ulnar artery 912 of the subject, for example, so that the bioinformation measuring device 100 can be created in a variety of sizes, the configuration may include any one of the first electrode 121 to the fourth electrode 124 (variant example 2), or a configuration of two electrodes in total, one for the radial artery 911 using either the first electrode 121 or the second electrode 122, and one for the ulnar artery 912 using either the third electrode 123 or the fourth electrode 124 (variant example 3).

<Electrode Modification 4>
The configuration may be one set (two in total), such as one set of the first electrode 121 and the second electrode 122 for the radial artery 911, or one set of the third electrode 123 and the fourth electrode 124 for the ulnar artery 912.

Here, in the configuration in which one set is provided for at least either the radial artery 911 or the ulnar artery 912, as in the above-mentioned embodiment and this modified example 4, for example, a configuration may be used in which the potential difference between both electrodes in one set is calculated. That is, for example, when the first arm portion 131 and the second arm portion 132 are elastically deformed and expanded at least in the left and right direction, or when the bioinformation measuring device 100 rotates in the circumferential direction of the wrist and is displaced, the electrode is separated from the artery and approaches extremely close to 0, and the influence of noise is more likely to appear, so that, for example, when one electrode is provided for the artery, it is necessary to arrange it in an appropriate position. On the other hand, by arranging one set of electrodes in a line in the circumferential direction of the wrist, for example, it is possible to arrange such that even if one electrode is separated from the artery, the other electrode is arranged near the artery, so that the detection accuracy of an electrocardiogram waveform accompanied by minute changes (inflection points) such as T waves can be improved. In addition, although the detected potential may be small, instead of the potential difference, the average value of the potential from both electrodes in one set may be calculated to be the electrocardiogram potential. Also, although this may complicate the judgment configuration, instead of using the potential difference, it is possible to select the potential of one of the two electrodes in a set as the electrocardiogram potential by comparing it with a reference potential for judgment or by comparing the potentials of both electrodes.

In addition, when two types of potentials, one for the radial artery 911 and one for the ulnar artery 912, are obtained as in the above-mentioned embodiment and variant example 2, the average value of the two may be calculated and used as the electrocardiographic potential, or it may be compared with a reference potential for judgment, or the potentials (potential difference) of the two may be compared, and the potential (potential difference) of one of the two types of electrodes may be used to detect the electrocardiographic waveform.

In addition, a thermistor may be connected to at least one of the first electrode 121 to the sixth electrode 126 to obtain the skin temperature. In particular, the fifth electrode 125 is more preferable than other electrodes as an electrode having a thermistor, considering that it is provided on the upper part of the main body 101. FIG. 4 shows an example in which a thermistor 1252 is connected to the fifth electrode 125 provided on the back side 103 of the main body 101. For example, the fifth electrode 125 may have a terminal 1251 connected to a reference potential (e.g., ground potential GND), and the thermistor 1252 may have a ground terminal 1253 and an output terminal 1254. For example, as illustrated in FIG. 4, the thermistor 1252 may be connected to the fifth electrode 125 via a thermally conductive adhesive 1255 having a high thermal conductivity, or may be directly connected to the fifth electrode 125 (e.g., a recess is made on the back side of the fifth electrode 125 and a part of the thermistor 1252 is inserted and fixed). This allows skin heat to be transferred to thermistor 1252 via an electrode that is in direct contact with the subject's skin (such as the fifth electrode 125 illustrated in FIG. 4), making it possible to measure the subject's skin temperature.

As shown in FIG. 1C, the optical sensor module 111 includes a light emitting unit 112 and a light receiving unit 113. The light emitting unit 112 includes, for example, a green light emitting LED, and the light receiving unit 113 includes a photodiode capable of receiving light emitted from the light emitting unit 112. The light emitting unit 112 is not limited to a green light emitting LED, and may be a red light emitting LED, a blue light emitting LED, an infrared LED, or the like, and may include multiple LEDs of the same color or multiple types of LEDs. More specifically, for example, the light emitting unit 112 may be configured to include a total of four LEDs, including two green light emitting LEDs, a red light emitting LED, and an infrared LED. The light receiving unit 113 may also be provided in a number corresponding to each LED included in the light emitting unit 112, or may be provided in common for several LEDs. The light irradiated from the light emitting unit 112 to the wrist is reflected inside the wrist and received by the light receiving unit 113. The pulse waveform can be measured based on the change in the intensity of the light received by the light receiving unit 113 over time, which is caused by the heartbeat of the subject's heart, and the pulse waveform that can be detected using this method is a photoelectric volume pulse waveform. The optical sensor module 111 is placed on the back of the wrist, and is placed in a position opposite the first electrode 121, etc. across the wrist. This allows the measurement sites of the electrocardiogram waveform measured by the first electrode 121, etc. and the photoelectric volume pulse waveform measured by the optical sensor module 111 to be separated. This allows the ventricular systolic pulse wave transit time PTT_SYS (Pulse Transit Time_Diastolic) and the ventricular diastolic pulse wave transit time PTT_DIA, which will be described later, to be lengthened, improving the reliability of the measurement.

Next, the configuration and overview of the biological information measurement system 1 including the server device 400 that calculates the biological information of the subject based on information from the biological information measurement device 100 in the first embodiment will be described with reference to FIG. 5. FIG. 5 is a block diagram of the biological information measurement system 1 in this embodiment.

As shown in FIG. 5, the bioinformation measuring system 1 of this embodiment is composed of a bioinformation measuring device 100, a terminal device 200, and a server device 400, and the terminal device 200 and the server device 400 are configured to be connectable to a network 300 such as the Internet or a LAN. The bioinformation measuring device 100 and the terminal device 200 may be integrated, or the bioinformation measuring device 100 may be provided with a network communication function that enables communication via the network 300, so that communication may be performed between the bioinformation measuring device 100 and the server device 400. In addition, a part or all of the calculation processing of the specified bioinformation (biogenic information) may be performed by the bioinformation measuring device 100 instead of the calculation by the server device 400. However, if the calculation is performed by the bioinformation measuring device 100, the calculation processing load will be high, which may lead to an increase in size and cost of the bioinformation measuring device 100, so calculation by the server device 400 is more preferable.

The biological information measuring device 100 includes an electrocardiogram detection unit 110, a pulse wave detection unit 120, a measuring device control unit 140, a measuring device storage unit 150, a measuring device operation unit 160, and a measuring device communication unit 170. These functional units are realized by executing a predetermined program for the biological information measuring device 100.

Examples of biometric information include electrocardiogram information and pulse wave information, and blood pressure information as biometric information obtained from these. However, biometric information is not limited to these and may include, using known techniques, for example, the subject's skin temperature information (body temperature information), acceleration information, and angular velocity information. Furthermore, biometric data obtained from these biometric information may include, for example, the subject's heart rate information, blood oxygen information, maximum oxygen intake information, blood glucose level information, respiratory rate, body temperature information, step count information, stride length information, center of gravity position information, posture information, stress information, amount of exercise information, exercise load information, distance traveled information, speed of movement information, activity amount information, and movement information of the wearing part such as the hand or leg.

The electrocardiogram detection unit 110 includes, for example, a first electrode 121 and a second electrode 122 for detecting the electrocardiogram of the radial artery, a third electrode 123 and a fourth electrode 124 for detecting the electrocardiogram of the ulnar artery, and a fifth electrode 125 for measuring the reference potential.

The pulse wave detection unit 120 includes an optical sensor module 111. The optical sensor module 111 is made up of the light-emitting unit 112 and the light-receiving unit 113 described above.

The measurement device control unit 140 is configured to include an electrocardiogram measurement control unit 141 and a pulse wave measurement control unit 142. The electrocardiogram measurement control unit 141 detects, for example, at least one of the difference in detected potential from the first electrode 121 and the second electrode 122, or the difference in detected potential from the third electrode 123 and the fourth electrode 124, amplifies it using the reference potential of the fifth electrode 125, and adds time information to create an electrocardiogram waveform. The pulse wave measurement control unit 142, for example, controls the emission of light from the light-emitting unit 112 of the pulse wave detection unit 120, and also receives a detection signal from the light-receiving unit 113.

The measuring device storage unit 150, for example, stores electrocardiogram information received by the electrocardiogram measurement control unit 117, and also stores pulse wave information received by the pulse wave measurement control unit 118. The electrocardiogram information includes electrocardiogram waveform information on an electrocardiogram waveform in which electrocardiogram information received by the measuring device control unit 140 is continuously arranged, and measurement time information of the electrocardiogram waveform and the like is added. The pulse wave information is information on a photoelectric volume pulse waveform in which pulse wave information received by the pulse wave measurement control unit 142 is continuously arranged, and measurement time information of the photoelectric volume pulse waveform and the like is added. The electrocardiogram information and pulse wave information are transmitted to the terminal device 200 via the measuring device communication unit 170 described later, but can also be temporarily stored when the frequency of transmission is reduced for power saving, etc., or when the communication connection with the terminal device 200 is cut off.

The measurement device operation unit 160 is an operation unit that allows the subject to perform operations such as powering on the biological information measurement device 100 and starting and ending measurement.

The measuring device communication unit 170 is a communication interface for communicating between the bioinformation measuring device 100 and an external device such as the terminal device 200. The measuring device communication unit 170 transmits, for example, electrocardiogram information received by the electrocardiogram measurement control unit 141 and pulse wave information received by the pulse wave measurement control unit 142, and electrocardiogram information and pulse wave information stored in the measuring device storage unit 150, to the terminal device 200, and receives information for operating the bioinformation measuring device 100 from the terminal device 200. Bluetooth (registered trademark) is used as the communication means in this embodiment. As other communication means, near field radio communication (NFC), Afero (registered trademark), Zigbee (registered trademark), Z-Wave (registered trademark), wireless LAN, etc. may be used. Alternatively, a wired connection may be made using the sixth electrode 126.

The terminal device 200 includes a terminal device control unit 211, a terminal device storage unit 212, and a terminal device communication unit 213. The terminal device 200 is an information processing device such as a smartphone, a mobile phone, a PHS, or a PDA. The terminal device 200 may be a terminal device dedicated to a biometric information measuring device, rather than a general-purpose device such as a smartphone. These functional units are realized by executing a specific program in the terminal device 200.

The terminal device control unit 211 controls the storage of biometric information such as electrocardiogram information and pulse wave information received by the terminal device communication unit 213 from the biometric information measuring device 100 in the terminal device storage unit 212, or transmits biometric information such as electrocardiogram information and pulse wave information from the terminal device storage unit 212 to the server device 400, or receives biometric information calculated by the server device 400 based on the biometric measurement information.

The terminal device storage unit 212 stores biometric information such as electrocardiogram information and pulse wave information received by the terminal device communication unit 213.

The terminal device communication unit 213 is a communication interface for communicating with the vital information measuring device 100 and the server device 400. It receives vital information such as electrocardiogram information and pulse wave information transmitted from the vital information measuring device 100, and also transmits setting information to the vital information measuring device 100 and request signals for vital information such as electrocardiogram information and pulse wave information. It also transmits vital information such as electrocardiogram information and pulse wave information to the server device 400, and also receives request signals for vital information such as electrocardiogram information and pulse wave information from the server device 400. In this embodiment, communication with the vital information measuring device 100 is performed using the aforementioned Bluetooth (registered trademark), but other communication means may be used. Also, communication with the server device 400 can be performed via a network 301 such as the Internet by wireless LAN.

The terminal device display unit 214 displays the biometric information and abnormality notifications sent from the biometric information measuring device 100 or the server device 400, for example, according to the rules of an application running on the terminal device 200.

The server device 400 includes a server device control unit 411, a server device communication unit 412, and a server device memory unit 413.

The server device control unit 411 includes a pulse wave propagation time calculation unit 421, which is a first calculation unit, and a bioinformation calculation unit 422, which is a second calculation unit. The server device control unit 411 (third calculation unit) calculates second-order differential data from photoelectric volume pulse waveform data. The pulse wave propagation time calculation unit 421 detects R waves and T waves from the waveform profile in the electrocardiogram information described later, and also detects P waves and D waves from the waveform profile in the photoelectric volume pulse waveform data, and calculates the ventricular systolic pulse wave propagation time PTT_SYS and the ventricular diastolic pulse wave propagation time PTT_DIA based on the information. The bioinformation calculation unit 422 calculates blood pressure information from the accelerated pulse wave characteristic information based on the second-order differential data calculated by the server device control unit 411 described later, and the ventricular systolic pulse wave propagation time PTT_SYS and the ventricular diastolic pulse wave propagation time PTT_DIA. Furthermore, the server device control unit 411 determines the health condition of the person being measured based on the blood pressure information and notifies the terminal device 200 of any abnormality. The pulse wave transit time calculation unit 421 may use first-order differential data or second-order differential data of the photoelectric volume pulse waveform data when detecting R waves and T waves.

The bioinformation calculation unit 422 can also obtain heart rate information as bioinformation (biologically generated information) from the interval between QRS waves in electrocardiogram waveform data (e.g., the electrocardiogram waveform data in FIG. 6 ) measured by the bioinformation measurement device 100 worn by the subject while at rest.

The bioinformation calculation unit 422 can also obtain temperature information as bioinformation (biogenic information) from the skin temperature information of the subject measured, for example, by a temperature sensor (such as a thermistor) of the bioinformation measurement device 100 worn by the subject.

The bioinformation calculation unit 422 can obtain walking speed information as bioinformation (biogenic information) by using known calculation methods alone or in combination (e.g., averaging, weighting, etc.) from waveform data of acceleration data measured by the bioinformation measurement device 100 worn on the wrist of the subject, and can obtain walking speed information as bioinformation (biogenic information) by integrating the acceleration data at predetermined intervals, for example.

The bioinformation calculation unit 422 can obtain stride information as bioinformation (biome-generated information) by using known calculation methods alone or in combination (e.g., averaging, weighting, etc.) from the waveform data of acceleration data measured by the bioinformation measurement device 100 worn by the subject on the wrist. For example, when walking, the hand swings like a pendulum, so the interval of one step can be determined based on the information from the acceleration sensor described above (e.g., the timing when the acceleration component in the direction of travel is the smallest or the timing when it switches to the opposite direction, the timing when the acceleration component in the direction perpendicular to the direction of travel is the smallest or the timing when it switches from up to down, etc.), and by further using time information, stride information can be obtained as bioinformation (biome-generated information). In addition, for example, when pushing off the ground, the acceleration component in the pushing direction is synthesized, so it is also possible to determine the interval of one step based on the timing of the occurrence of the acceleration component in that direction.

The bioinformation calculation unit 422 can also obtain motion information, such as the speed and angle at which the part of the body (e.g., the wrist or ankle) on which the bioinformation measuring device 100 is worn, is moving as bioinformation (biome-generated information) from, for example, acceleration data and angular velocity data measured by the bioinformation measuring device 100 worn by the subject.

The biometric information calculation unit 422 also performs frequency analysis on the acceleration data measured by the biometric information measurement device 100 that is worn daily, and calculates activity amount information as biometric information (biometric information) based on predetermined conditions, such as, for example, correlating high and low frequencies with high and low activity frequency, and calculating what percentage of a day activity occurs at a predetermined frequency or higher.

The bioinformation calculation unit 422 can identify acceleration data during exercise, including walking, from acceleration data measured by the bioinformation measurement device 100 that is worn daily, using a known calculation method, for example, and can obtain locomotion information as bioinformation (biogenesis information) by calculating under specified conditions using, for example, frequency analysis. Furthermore, by further using additional information such as angular velocity information, it is possible to obtain more accurate locomotion information.

The bioinformation calculation unit 422 can obtain exercise load information as bioinformation (biome-generated information) by weighting the activity amount information and exercise amount information derived from acceleration data measured by the bioinformation measurement device 100 worn daily, for example, with heart rate information that increases with exercise load. Furthermore, by adding vector information of the acceleration data, for example, it is possible to identify status information such as the walking environment (slope, stairs, etc.) and posture (standing, sitting, etc.), and this status information may also be used. Furthermore, by using additional information such as angular velocity information, it is possible to obtain more accurate exercise load information.

In addition, the bioinformation calculation unit 422 can obtain maximum oxygen intake information as bioinformation (biogenic information) using, for example, the above-mentioned resting heart rate information by a known formula such as _VO2 max = 15 x (220 - age) ÷ resting heart rate.

In addition, a machine learning model may be created in advance based on teacher data in which, for example, biometric information is associated with biogenerated information (e.g., heart rate information and blood pressure information) generated based on the biometric information and positive biometric information (e.g., heart rate information and blood pressure information based on a known medical device) based on a correspondence relationship (which may include, for example, information indicating the degree or range of error) using a known learning device, and the biometric information calculation unit 422 may generate biometric information by making a judgment using the machine learning model as the above-mentioned specified calculation (analysis).

The server device communication unit 412 is a communication interface for communicating with the terminal device 200 via a network 300 such as the Internet. It receives biometric information such as electrocardiogram information and pulse wave information transmitted from the terminal device 200, and also transmits a request signal for biometric information such as electrocardiogram information and pulse wave information to the terminal device 200. It also transmits an abnormality notification to the terminal device 200.

The server device storage unit 413 stores biometric information such as electrocardiogram information and pulse wave information received by the server device communication unit 412. It also stores blood pressure information calculated by the biometric information calculation unit 422.

<Electrocardiogram waveform, photoelectric volume pulse waveform, velocity pulse waveform, acceleration pulse waveform, blood pressure information calculation method>
Fig. 6 shows the electrocardiogram waveform and photoelectric volume pulse waveform of a non-measured person measured by the bioinformation measuring device 100, and the velocity pulse waveform and acceleration pulse waveform calculated by the server device 400. From the top of Fig. 6, the electrocardiogram waveform, photoelectric volume pulse waveform, velocity pulse waveform, and acceleration pulse waveform are shown. The vertical axis shows the intensity of each waveform, and the electrocardiogram waveform and photoelectric volume pulse waveform are expressed in mV, which indicates potential. The horizontal axis shows the passage of time, and the passage of time is shown from left to right.

An electrocardiogram waveform is a waveform that shows the periodic changes in the electrical signal that causes the human heart to beat. The inflection points of the electrocardiogram waveform are assigned the names P wave, Q wave, R wave, S wave, and T wave, and represent one cycle of the heartbeat. The P wave represents atrial contraction, the Q wave, R wave, and S wave represent ventricular contraction, and the T wave represents the start of ventricular expansion.

The photoelectric volume pulse waveform is a waveform that indicates the changes in blood pressure and volume in the peripheral vascular system that accompany the beating of the human heart. The inflection points of the photoelectric volume pulse waveform are assigned the names A wave, P wave, V wave, and D wave, respectively, and indicate one cycle of the heartbeat. With the A wave as the reference point for the time when the arterial pulse wave is generated, the P wave indicates the percussion wave (shock wave) generated by left ventricular ejection, the V wave indicates the valley wave (wave caused by dicrotic prominence) generated when the aortic valve is closed, and the D wave indicates the diastolic wave (dichotic wave), which is a reflected vibration wave.

The velocity pulse waveform is the first derivative of the photoelectric volume pulse waveform with respect to time. The acceleration pulse waveform is the first derivative of the velocity pulse waveform with respect to time, that is, the second derivative of the photoelectric volume pulse waveform. As shown in Figure 6, the peaks of the acceleration pulse waveform are assigned the names a wave (early positive systolic wave), b wave (early negative systolic wave), c wave (mid-systolic re-upward wave), d wave (late systolic re-downward wave), e wave (early positive diastolic wave), and f wave (early negative diastolic wave). The ratio of the intensity of the b wave to the intensity of the a wave, and the ratio of the intensity of the f wave to the intensity of the e wave are parameters that indicate the elasticity, or elasticity, of blood vessels. The main components of blood vessels are endothelium, elastic fiber, collagen, and smooth muscle. Each of these components has different properties, with collagen and elastin having a strong influence on the elasticity of blood vessels at maximum and minimum blood pressure, respectively. Therefore, elasticity that differs depending on blood pressure values can be expressed by parameters (b/a), which is the ratio of the intensity of b waves to the intensity of a waves, and (f/e), which is the ratio of the intensity of f waves to the intensity of e waves, and these values also vary depending on age, sex, and environmental variables (such as temperature). Therefore, the values of (b/a) and (f/e) can be calculated as characteristic information of the accelerated pulse waveform.

As shown in FIG. 6, the difference between the time Tr when the R wave occurs and the time Tp when the P wave occurs is the ventricular systolic pulse wave propagation time PTT_SYS. The difference between the time Tt when the T wave occurs and the time Td when the D wave occurs is the ventricular diastolic pulse wave propagation time PTT_DIA. In other words, the ventricular systolic pulse wave propagation time PTT_SYS and the ventricular diastolic pulse wave propagation time PTT_DIA can be calculated from the time Tr of the R wave and the time Tt of the T wave of the electrocardiogram waveform, and the time Tp of the T wave and the time Td of the D wave of the photoelectric volume pulse waveform, as shown in equations (1) and (2).

PTT_SYS=Tp-Tr...(1)

PTT_DIA=Td-Tt...(2)

The first electrode 121 to the fourth electrode 124 for measuring the electrocardiogram waveform and the optical sensor module 111 for measuring the photoelectric volume pulse waveform are opposed to each other via the wrist, and by separating them, the detection site of the electrocardiogram waveform and the measurement site of the photoelectric volume pulse waveform are separated. Therefore, by creating a time lag for the generation of each characteristic waveform, the absolute calculation time of the ventricular systolic pulse wave propagation time PTT_SYS and the ventricular diastolic pulse wave propagation time PTT_DIA can be made longer. Therefore, when obtaining change information of the ventricular systolic pulse wave propagation time PTT_SYS and the ventricular diastolic pulse wave propagation time PTT_DIA, the accuracy of the change information can be improved.

Here, we explain the formula for calculating blood pressure.

The relationship between pulse wave velocity and the longitudinal elastic modulus of the arterial wall is shown in the following equation (3) (Moens-Korteweg equation).

L/T_PTT=√(E・h/(2・r・ρ)) ...(3)

The parameters in equation (3) are: L: measurement distance, T_PTT: pulse wave transit time, r: blood vessel inner diameter, E: blood vessel longitudinal elastic modulus, h: blood vessel thickness, and ρ: blood density.

It is known that there is a correlation between the longitudinal elastic modulus and blood pressure,

E=E ₀・exp(α・P)...(4)

Here, P is the blood pressure value, α is a constant, and E ₀ is an initial value.

From equations (3) and (4)

P=(-2・ln(T_PTT)+ln(2・r・ρ・L ² /(E ₀・h)))/α...(5)

can be derived. ln indicates natural logarithm. In this case, since "r·ρ" is proportional to the blood volume at the measurement site, it can be shown as the high value (Vp, Vd) shown on the photoelectric volume pulse waveform. Also, since "E ₀ ·h" is a value proportional to the elasticity of the blood vessels, it can be replaced by the parameters (b/a) and (f/e) that indicate the elasticity.

Therefore, the systolic blood pressure BP_SYS (Blood Pressure_Systolic) and the diastolic blood pressure BP_DIA (Blood Pressure_Diastolic) can be expressed by the following equations (6) and (7).

BP_SYS=A1・ln(PTT_SYS)+A2・ln(Vp)+A3・ln(b/a)+A4...(6)

BP_DIA=A5・ln(PTT_DIA)+A6・ln(Vd)+A7・ln(f/e)+A8...(7)

A1 to A8 are constants determined by conditions. The systolic blood pressure BP_SYS that can be calculated using formula (6) can be calculated by multiplying the natural logarithm of the ventricular systolic pulse wave transit time PTT_SYS by a constant A1, multiplying the natural logarithm of the P-wave intensity Vp by a constant A2, multiplying the natural logarithm of (b/a) by a constant A3, and the sum of the constant A4. The diastolic blood pressure BP_SYS that can be calculated using formula (7) can be calculated by multiplying the natural logarithm of the ventricular systolic pulse wave transit time PTT_DIA by a constant A5, multiplying the natural logarithm of the D-wave intensity Vd by a constant A6, multiplying the natural logarithm of (f/e) by a constant A7, and the sum of the constant A8. The systolic blood pressure BP_SYS and the diastolic blood pressure BP_DIA can be calculated by calculating each constant based on the characteristics of the device, the person being measured, etc. However, when checking the change state of the systolic blood pressure BP_SYS and the diastolic blood pressure BP_DIA, it is not necessary to determine all the constants, and it is possible to obtain values as information on the systolic blood pressure BP_SYS and the diastolic blood pressure BP_DIA by substituting provisional values. The natural logarithm of the P wave intensity Vp and the natural logarithm of the D wave intensity Vd are terms that take into account the influence of blood density. In addition, the natural logarithm of (b/a) and the natural logarithm of (f/e) are terms that take into account the influence of the longitudinal elastic modulus of the arterial wall. Therefore, depending on the measurement conditions, the information on the systolic blood pressure BP_SYS and the diastolic blood pressure BP_DIA may be calculated by selecting one of the terms and making the other terms constant.

<Processing flow>
Next, the operation of the biological information measuring system 1 according to the first embodiment of the present invention will be described with reference to the flowchart illustrated in Fig. 7. The flowchart in Fig. 7 shows the associated states of the operations of the biological information measuring device 100, the terminal device 200, and the server device 400.

In step S101, the bioinformation measuring device 100 performs a loop until the subject starts measurement and performs an end operation, up until step S122.

In step S102, the electrocardiogram measurement control unit 141 detects the electrocardiogram from the first electrode 121 to the fourth electrode 124. Note that steps S102 and S104, and steps S103 and S105 are processed simultaneously in parallel.

In step S103, the electrocardiogram measurement control unit 141 generates an electrocardiogram waveform from the time change of the electrocardiogram detected in step S102.

In step S104, the pulse wave measurement control unit 142 controls the optical sensor module 111 to detect the pulse wave. Specifically, the light emitting LED of the light emitting unit 112 is caused to emit light and irradiate the wrist. The light receiving unit 113 receives the light reflected from the wrist. The light receiving unit 113 converts the received light into an electrical signal using the photodiode of the light receiving unit 113, and transmits it to the pulse wave measurement control unit 142 as pulse wave information.

In step S105, the pulse wave measurement control unit 142 generates a photoelectric volume pulse waveform from the time change in the pulse wave information based on the pulse wave detected in step S104.

In step S106, the measurement device control unit 140 adds the detected time to the electrocardiogram waveform generated in step S103 and the photoelectric volume pulse waveform generated in step S105 as the measurement time, and stores the electrocardiogram information and pulse wave information in the measurement device storage unit 150.

In step S107, the measuring device control unit 140 determines whether or not a measuring device data transmission trigger is present. If the measuring device data transmission trigger is "present", i.e., "Y", proceed to step S107, and if it is "absent", i.e., "N", proceed to step S122. The measuring device data transmission trigger is an internal parameter in the vital information measuring device 100, and if electrocardiogram information and pulse wave information are constantly transmitted from the vital information measuring device 100 to the terminal device 200, the parameter is always set to "present", i.e., "1". If electrocardiogram information and pulse wave information are periodically transmitted from the vital information measuring device 100 to the terminal device 200, an internal counter sets the measuring device data communication trigger to "1" at the set timing. The measuring device data communication trigger may also be set to "1" upon a request from the terminal device 200.

In step S108, the measurement device control unit 140 transmits the electrocardiogram information and pulse wave information stored in the measurement device storage unit 150 to the terminal device 200.

In step S109, the terminal device control unit 211 stores the electrocardiogram information and pulse wave information received by the terminal device communication unit 213 in the terminal device storage unit 212.

In step S110, the terminal device control unit 211 determines whether or not a terminal device data transmission trigger is present. If the terminal device data transmission trigger is "present", i.e., "Y", the process proceeds to step S111, and if the terminal device data transmission trigger is "absent", i.e., "N", the process proceeds to step S121. The terminal device data transmission trigger is an internal parameter in the terminal device 200, and if electrocardiogram information and pulse wave information are constantly transmitted from the terminal device 200 to the server device 400, the parameter is always set to "present", i.e., "1". If electrocardiogram information and pulse wave information are periodically transmitted from the terminal device 200 to the server device 400, the terminal device data communication trigger is set to "1" at the set timing by an internal counter. The terminal device data communication trigger may also be set to "1" in response to a request from the server device 400.

In step S111, the terminal device control unit 211 transmits the electrocardiogram information and pulse wave information stored in the terminal device storage unit 212 to the server device 400.

In step S112, the server device control unit 411 stores the electrocardiogram information and pulse wave information received by the server device communication unit 412 in the server device storage unit 413.

In step S113, the server device control unit 411 calculates the pulse wave propagation time from the electrocardiogram information and pulse wave information stored in the server device storage unit 413. A specific operation procedure is described below. The pulse wave propagation time calculation unit 421 extracts a waveform profile in the electrocardiogram information and a waveform profile in the pulse wave information that are close in measurement timing. Next, the pulse wave propagation time calculation unit 421 detects R waves and T waves from the waveform profile in the electrocardiogram information, and stores the time information at which the detected R waves and T waves occurred as Tr and Tt. Similarly, the pulse wave propagation time calculation unit 421 detects P waves and D waves from the waveform profile in the photoelectric volume pulse waveform data, and stores the time information at which the detected P waves and D waves occurred as Tp and Td. At the same time, it also detects and stores the intensity Vp of the P wave and the intensity Vd of the D wave. The pulse wave propagation time calculation unit 421 calculates the difference between the time information Tr when the R wave occurs and the time information Tp when the P wave occurs, as shown in Figure 6, to calculate the ventricular systolic pulse wave propagation time PTT_SYS. Similarly, it calculates the difference between the time information Tt when the T wave occurs and the time information Td when the D wave occurs to calculate the ventricular diastolic pulse wave propagation time PTT_DIA.

In step S114, the server device control unit 411 calculates second-order differential data from the photoelectric volume pulse waveform data stored in the server device storage unit 413. Specifically, as shown in FIG. 6, the photoelectric volume pulse waveform data is first differentiated, and the first-order differentiated data is further differentiated to obtain second-order differential data. The waveform obtained by second-order differentiation of the pulse wave is called an accelerated pulse waveform.

In step S115, the server device control unit 411 calculates characteristic information of the accelerated pulse waveform from the second derivative data obtained in step S114. The characteristic information of the accelerated pulse waveform is found by performing a calculation from the intensities of the a-wave, b-wave, e-wave, and f-wave, which indicate the peaks of the accelerated pulse waveform described above.

In step S116, the server device control unit 411 calculates blood pressure information from the ventricular systolic pulse wave transit time PTT_SYS and ventricular diastolic pulse wave transit time PTT_DIA obtained in step S113 and the characteristic information of the accelerated pulse waveform obtained in step S115. Blood pressure information related to maximum blood pressure is calculated from the ventricular systolic pulse wave transit time PTT_SYS and the characteristic information of the accelerated pulse waveform, and blood pressure information related to minimum blood pressure is calculated from the ventricular diastolic pulse wave transit time PTT_DIA and the characteristic information of the accelerated pulse waveform. The calculation is performed using the above-mentioned equations (6) and (7).

In step S117, the server device control unit 411 stores the blood pressure information calculated in step S116 in the server device storage unit 413.

In step S118, the server device control unit 411 analyzes the change in the blood pressure information stored in the server device storage unit 413. If the change is determined to be a deterioration in the subject's health condition, the judgment flag is set to "Yes" as an abnormality. The judgment flag is an internal parameter of the server device 400.

In step S119, the server device control unit 411 determines whether the determination flag is "Yes". If it is "Yes", the process proceeds to step S120, and if it is "No", the flow ends.

In step S120, the server device control unit 411 notifies the terminal device 200 of the abnormality via the server device communication unit 412.

In step S121, the terminal device control unit 211 controls the terminal device display unit 214 to display a message notifying the subject of an abnormality in their health condition based on the abnormality notification received by the terminal device communication unit 213. This enables the terminal device 200 to notify the subject of the abnormality in their health condition.

In step S122, the biometric measuring device 100 loops back to step S101 until the biometric measuring device 100 is powered off or the measuring device control unit 140 performs an operation to end the measurement.

<Explanation of effect>
As described above, the bioinformation measuring device 100 of the present invention, particularly by having the first arm portion 131 and the second arm portion 132, can accommodate subjects with a variety of arm thicknesses and can improve the detection accuracy of the electrocardiogram waveform.

Although several embodiments of the present invention have been described above, these embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their modifications are considered to be within the scope of the invention and its equivalents as set forth in the claims, as well as within the scope and spirit of the invention.

1 ... Biological information measuring system 100 ... Biological information measuring device 200 ... Terminal device 300 ... Network 400 ... Server device

Claims (7)

A biological information measuring device having at least a main body,
The main body includes a first arm and a second arm that are curved and extend to the left and right from an upper portion to a lower portion of the main body,
the ends of the first arm and the second arm are separated from each other;
the first arm portion has a first electrode and a second electrode arranged side by side in a circumferential direction of the wrist near the radial artery on the palm side of the wrist to acquire first electrocardiographic information related to the radial artery;
The second arm portion has a third electrode and a fourth electrode arranged side by side in a circumferential direction of the wrist near the ulnar artery on the palm side of the wrist to acquire second electrocardiographic information related to the ulnar artery.
Biometric information measuring device. The biological information measuring device according to claim 1, further comprising an amplifier that amplifies the potential difference between two electrodes provided on the same end side. The biological information measuring device according to claim 1 , further comprising a configuration for calculating an average value of two electrodes provided on the same end side. The biological information measuring device of claim 1, further comprising a second electrode arranged on an upper side of the main body, which is on the back side of the wrist, and acquiring a reference voltage to be compared with at least one of the first electrocardiogram information or the second electrocardiogram information. The biological information measuring device according to claim 1, wherein at least one of the first arm and the second arm extends outward in the front-to-rear direction at the lower part of the main body. The biological information measuring device according to claim 5, wherein at least a portion of both ends of the first arm and the second arm extend to a length such that they overlap each other in the front-to-rear direction at the lower part of the main body. The biological information measuring device according to claim 1 , wherein the main body does not have a display unit and includes a communication unit that outputs at least one of the acquired first electrocardiogram information and the acquired second electrocardiogram information to an outside.
a terminal device that displays on a display unit bio-generated information generated based on the information output from the communication unit to the outside;
An information system comprising:

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