Biological monitoring device

Abstract

This biological monitoring device is provided with a sensor unit substrate on which one sensor or a plurality of sensors are mounted and a control unit substrate on which a power supply, a control unit and a storage unit are mounted. The sensor unit substrate has a sensor-mounted region in which the sensor is mounted and an extraction region including a power supply line and a signal line between the control unit substrate and the sensor unit substrate, and the sensor-mounted region is embedded in a living body.

Description

Biological monitoring devices

[0001] This application claims priority to Japanese Patent Application No. 2023-003002, filed on January 12, 2023, the contents of which are incorporated herein by reference.

[0002] Conventionally, medical sensors that are implanted in the human body and used have been known (see, for example, Patent Document 1). Patent Document 1 describes a medical sensor that includes an electronic device having a sensor with an accelerometer, a bidirectional wireless communication system electronically connected to the electronic device for transmitting an output signal from the sensor to an external device and receiving commands from an external controller to the electronic device, and a wireless power supply system for supplying power to the electronic device.

[0003] Special Publication No. 2021-513895

[0004] However, the medical sensor described in the above-mentioned Patent Document 1 requires an antenna and circuit for wirelessly supplying power to the medical sensor implanted in the body, but the antenna and circuit increase the size of the medical sensor. This increases the burden on the human body in which the medical sensor is implanted. Furthermore, a power supply device for wirelessly supplying power to the medical sensor must be installed near the human body. Furthermore, when the medical sensor is applied to small animals, if the size of the medical sensor becomes too large, the small animals may not be able to perform their normal activities, and the biological information obtained by the medical sensor may not be effective for analyzing the ecology of the small animals.

[0005] The present invention has been made in consideration of the above circumstances, and its object is to reduce the burden on a living body in which a sensor is implanted.

[0006] One aspect of the present invention is a biological monitoring device comprising a sensor unit substrate on which one or more sensors are mounted, and a control unit substrate on which a power supply, a control unit, and a memory unit are mounted, the sensor unit substrate having a sensor mounting area on which the sensors are mounted, and an extraction area including power lines and signal lines between the sensor mounting area and the control unit substrate, and the sensor mounting area is embedded in a living body.

[0007] One aspect of the present invention is the biological monitoring device described above, wherein the sensor unit substrate has a displacement prevention portion that prevents the sensor unit substrate from being displaced in the sensor mounting area.

[0008] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention portion has a protrusion.

[0009] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention portion has a hole.

[0010] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention portion has a protrusion and a hole.

[0011] One aspect of the present invention is a biological monitoring device as described above, wherein the anti-slip portion is a portion of the surface of the sensor unit substrate that has been surface-treated with a chemical substance that promotes adhesion with biological tissue.

[0012] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention portion is a minute unevenness provided on at least a part of the surface of the sensor unit substrate.

[0013] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention portion is made of a bioabsorbable material.

[0014] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention unit is located on the outer periphery of the sensor unit substrate.

[0015] One aspect of the present invention is the biological monitoring device described above, wherein the slippage prevention portion is disposed approximately perpendicular to the interface between the epidermis and the subcutaneous tissue.

[0016] One aspect of the present invention is the biological monitoring device described above, wherein the sensor unit substrate has a plurality of the slippage prevention units.

[0017] One aspect of the present invention is the biological monitoring device described above, wherein the sensor unit substrate has a plurality of the slippage prevention portions in positions that do not overlap when the sensor unit substrate is viewed from above.

[0018] One aspect of the present invention is a biological monitoring device as described above, wherein the sensor mounting area has an anti-slip structure on the pull-out area side that prevents the sensor mounting area from slipping out of the living body.

[0019] One aspect of the present invention is the biological monitoring device described above, wherein the sensor mounting area has a rounded shape on the side opposite the pull-out area.

[0020] One aspect of the present invention is the biological monitoring device described above, wherein an adhesion inhibitor is applied to the periphery of the sensor in the sensor mounting area.

[0021] One aspect of the present invention is a biological monitoring device as described above, in which the sensor unit substrate has the sensor mounted on the side of the sensor mounting area that is inside the body when implanted in a living body, of both sides of the sensor mounting area.

[0022] One aspect of the present invention is the biological monitoring device described above, in which a temperature sensor or a pulse wave sensor, or both a temperature sensor and a pulse wave sensor, are mounted as the sensors on the surface inside the body.

[0023] One aspect of the present invention is the biological monitoring device described above, wherein the sensor unit substrate has a chamfered edge in the sensor mounting area.

[0024] One aspect of the present invention is a biological monitoring device in which, in the above-mentioned biological monitoring device, a wireless communication unit is further implemented on the control unit board, and the control unit causes the sensor output signal stored in the memory unit to be wirelessly transmitted to an external device via the wireless communication unit.

[0025] One aspect of the present invention is a biological monitoring device further comprising a clock unit, wherein the memory unit stores a sensor output signal in association with a recording time, which is the time measured by the clock unit, the control unit causes the wireless communication unit to wirelessly transmit a predetermined signal to the external device at a predetermined transmission period based on the time measured by the clock unit, the control unit causes the wireless communication unit to wirelessly transmit the sensor output signal and the recording time associated with the sensor output signal to the external device, and the external device corrects the time series data of the sensor output signal and the recording time wirelessly received by the external device based on the reception time of the predetermined signal wirelessly received by the external device.

[0026] One aspect of the present invention is the biological monitoring device described above, wherein the control unit causes the wireless communication unit to wirelessly transmit a signal indicating the operating status of the biological monitoring device to an external device.

[0027] One aspect of the present invention is the biological monitoring device described above, wherein the control unit notifies the user whether the installation position of the sensor is normal or not.

[0028] One aspect of the present invention is the biological monitoring device described above, wherein the sensor mounting area and the control unit board are non-flexible, and the draw-out area is flexible.

[0029] One aspect of the present invention is a biological monitoring device as described above, wherein the sensor unit substrate is arranged so that the drawer area spans both inside and outside the body, and the control unit substrate is arranged outside the body.

[0030] One aspect of the present invention is the biological monitoring device described above, wherein the drawer region has a constricted shape.

[0031] One aspect of the present invention is the biological monitoring device described above, wherein the drawer region has a plurality of constricted shapes in a direction in which the drawer region extends.

[0032] One aspect of the present invention is the biological monitoring device described above, wherein the drawer area has a narrowed shape with a width shorter than both ends on the sensor mounting area side and the control unit board side.

[0033] One aspect of the present invention is the biological monitoring device described above, wherein the pull-out region has one or more curved portions.

[0034] One aspect of the present invention is the biological monitoring device described above, wherein the pull-out area has a meandering shape formed by a plurality of bends.

[0035] One aspect of the present invention is the biological monitoring device described above, wherein the drawer area has a wedge shape.

[0036] One aspect of the present invention is the biological monitoring device described above, wherein the sensor unit substrate has a pressurizing mechanism that presses the sensor mounting area toward the inside of the living body.

[0037] One aspect of the present invention is the biological monitoring device described above, wherein at least one of the sensor unit board and the control unit board has a connector region that fits into a connector.

[0038] One aspect of the present invention is the biological monitoring device described above, wherein the connector is arranged on the sensor unit board on the side of the control unit board that is arranged outside the living body.

[0039] One aspect of the present invention is a biological monitoring device in which, in the above-mentioned biological monitoring device, the control unit board has a connector area that fits into a control unit side connector as the connector, the control unit side connector can be used to connect to an external device, and the control unit or the memory unit is configured to be operable from an external device connected to the control unit board by the control unit side connector.

[0040] One aspect of the present invention is a biological monitoring device in which, in the above-mentioned biological monitoring device, the sensor unit board has a connector area that fits into a sensor side connector as the connector, the sensor side connector can be used to connect to an external device, and the sensor is configured to be operable from an external device connected to the sensor unit board by the sensor side connector.

[0041] One aspect of the present invention is a biological monitoring device comprising a sensor unit board on which one or more sensors are mounted, and a control unit board on which a power supply, a control unit, and a memory unit are mounted, the sensor unit board having a sensor mounting area on which the sensor is mounted, an extraction area including power lines and signal lines between the sensor unit board and the control unit board, and a connector area on which a sensor side connector that fits into the control unit side connector of the control unit board is mounted, the sensor unit board and the control unit board are configured to be detachable using the sensor side connector and the control unit side connector, the sensor unit board has the sensor mounting area embedded in a living body, the control unit board is used by connecting the control unit side connector to the sensor side connector, the control unit side connector and the sensor side connector connect the power lines and the signal lines between the control unit board side and the sensor unit board side, the sensor operates by receiving power from the power supply, and the memory unit stores a sensor output signal output from the sensor.

[0042] According to the present invention, it is possible to obtain an effect of reducing the burden on the living body in which the sensor is implanted.

[0043] FIG. 1 is a block diagram showing an example of the configuration of a biological monitoring system according to an embodiment. FIG. 1 is a plan view showing an example of the mounting configuration of a sensor unit substrate according to an embodiment. FIG. 2 is a cross-sectional view showing an example of the substrate configuration of a sensor unit substrate according to an embodiment. FIG. 2 is a plan view and a cross-sectional view showing an example of the substrate configuration of metal wiring in a lead-out region according to an embodiment. FIG. 3 is a plan view and a cross-sectional view showing an example of the substrate configuration of metal wiring in a lead-out region according to a comparative example. FIG. 3 is a plan view and a cross-sectional view showing an example of the substrate configuration of metal wiring in a lead-out region according to a comparative example. FIG. 4 is an explanatory diagram showing an example of usage of a biological monitoring device according to an embodiment. FIG. 5 is a diagram showing an example of processing of a sensor output signal according to an embodiment. FIG. 6 is a plan view showing an example of the mounting configuration of a sensor unit substrate according to an embodiment. FIG. 7 is a plan view showing an example of the mounting configuration of a sensor unit substrate according to an embodiment. FIG. 8 is a plan view and a cross-sectional view showing an example of the mounting configuration of a slippage prevention unit according to an embodiment. FIG. 9 is a plan view and a cross-sectional view showing an example of the mounting configuration of a slippage prevention unit according to an embodiment. FIG. 10 is a diagram showing an example of a method of inserting a sensor mounting region according to an embodiment into a living body. FIG. 11 is an explanatory diagram showing an example of usage of a biological monitoring device having a slip-out prevention structure according to an embodiment. FIG. 12 is an explanatory diagram showing an example of usage of a biological monitoring device having a pressurizing mechanism according to an embodiment.

[0044] Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a block diagram showing an example of the configuration of a biological monitoring system according to one embodiment. In FIG. 1, the biological monitoring system includes a biological monitoring device 1 and an external device 5. The biological monitoring device 1 and the external device 5 communicate wirelessly. The biological monitoring device 1 and the external device 5 can also communicate wired via a signal line L2. Note that FIG. 1 shows a connection between the control units 103 and 503 via the signal line L2 as an example of the connection between the signal line L2 between the biological monitoring device 1 and the external device 5, but this is not limiting. For example, the memory unit 104 or the wireless communication unit 107 of the biological monitoring device 1 may be connected to the control unit 503 of the external device 5 via the signal line L2. In this case, the control unit 503 of the external device 5 may directly control the memory unit 104 or the wireless communication unit 107 of the biological monitoring device 1.

[0045] The biological monitoring device 1 includes a control unit board 10 and a sensor unit board 20. Mounted on the control unit board 10 are a battery 101, a power distribution unit 102, a control unit 103, a memory unit 104, a quartz oscillator 105, an antenna 106, and a wireless communication unit 107. Mounted on the sensor unit board 20 are a temperature sensor 201, a pulse wave sensor 202, and an acceleration sensor 203. Hereinafter, when there is no need to distinguish between the temperature sensor 201, the pulse wave sensor 202, and the acceleration sensor 203, they will be referred to as sensors 20X.

[0046] Furthermore, a sensor-side connector CN1 (not shown in FIG. 1) is mounted on the sensor board 20, and a control-side connector CN2 (not shown in FIG. 1) is mounted on the control board 10. The sensor-side connector CN1 and the control-side connector CN2 are mated together. The sensor board 20 and the control board 10 are configured to be detachable using the sensor-side connector CN1 and the control-side connector CN2. The sensor board 20 and the control board 10 are connected by mating the sensor-side connector CN1 and the control-side connector CN2. The sensor board 20 and the control board 10 are detached by removing the sensor-side connector CN1 and the control-side connector CN2.

[0047] The control unit side connector CN2 and the sensor side connector CN1 connect the power supply lines P1, P2 and the signal line L1 between the control unit board 10 and the sensor unit board 20. Specifically, when the control unit side connector CN2 and the sensor side connector CN1 are mated, the power supply lines P1, P2 and the signal line L1 are connected between the control unit board 10 and the sensor unit board 20. On the other hand, when the control unit side connector CN2 and the sensor side connector CN1 are detached, the power supply lines P1, P2 and the signal line L1 are disconnected between the control unit board 10 and the sensor unit board 20.

[0048] The battery 101 is a power source that supplies power to each unit mounted on the control unit board 10 and the sensor 20X mounted on the sensor unit board 20. The power distribution unit 102 distributes the power supplied from the battery 101 to each unit mounted on the control unit board 10 and the sensor 20X mounted on the sensor unit board 20.

[0049] 1 is configured so that power is supplied to the components mounted on the control unit board 10 and the sensor 20X mounted on the sensor unit board 20 only when the control unit side connector CN2 and the sensor side connector CN1 are mated. Specifically, as shown in FIG. 1 , a power line P1 for supplying power from a battery 101 is wired so as to run from the control unit board 10 through the sensor unit board 20 and then connect to a power distribution unit 102 of the control unit board 10. Power lines (not shown) are wired on the control unit board 10 from the power distribution unit 102 to the components mounted on the control unit board 10. Furthermore, a power line P2 is wired from the power distribution unit 102 so as to connect from the control unit board 10 to the sensor 20X mounted on the sensor unit board 20.

[0050] 1 are wired in this manner, when the control unit side connector CN2 and the sensor side connector CN1 are mated, power is supplied from the battery 101 via the power line P1 to the components mounted on the control unit board 10 through the power distribution unit 102, and power is supplied via the power line P2 to the sensor 20X mounted on the sensor unit board 20. On the other hand, when the control unit side connector CN2 and the sensor side connector CN1 are disconnected, power supply from the battery 101 to the components mounted on the control unit board 10 and the sensor 20X mounted on the sensor unit board 20 is stopped. As a result, when the control unit side connector CN2 and the sensor side connector CN1 are disconnected, only power is consumed by natural discharge, which has the effect of suppressing wear on the battery 101.

[0051] The sensor 20X operates by receiving power from the battery 101. The sensor 20X outputs a detection signal detected by itself. The temperature sensor 201 outputs a temperature detection signal indicating the temperature detected by itself. The pulse wave sensor 202 outputs a pulse wave detection signal indicating the pulse wave detected by itself. The acceleration sensor 203 outputs an acceleration detection signal indicating the acceleration detected by itself. The detection signal (sensor output signal) output from the sensor 20X is transmitted to the control unit 103 mounted on the control unit board 10 via the signal line L1.

[0052] The signal line L1 is a bidirectional serial communication signal line that includes a transmission clock, a first signal, and a second signal. The first signal is a signal that is transmitted from the sensor 20X to the control unit 103 in synchronization with the transmission clock. The second signal is a signal that is transmitted from the control unit 103 to the sensor 20X in synchronization with the transmission clock.

[0053] The control unit 103 controls the sensor 20X mounted on the sensor unit board 20, and the storage unit 104 and wireless communication unit 107 mounted on the control unit board 10. The control unit 103 has preset measurement conditions. The control unit 103 sets measurement for the sensor 20X according to the measurement conditions. The control unit 103 also samples the sensor output signal at regular intervals according to the measurement conditions, and stores the sampled sensor output signal in the storage unit 104 in association with a recording time. The recording time is the time measured by the clock unit. The recording time is indicated, for example, in units of year, month, day, hour, minute, and second. Note that the recording time is not limited to the time of day, and may be an index indicating the elapsed time from a reference time. The recording time may indicate, for example, the elapsed time from the time the control unit 103 was started.

[0054] The storage unit 104 stores various data such as sensor output signals.

[0055] The quartz crystal oscillator 105 generates a fundamental frequency signal having a fundamental frequency for generating a clock used in the biological monitoring device 1. The fundamental frequency signal is used, for example, as the operating frequency of the clock of the control unit 103. The time of the clock of the control unit 103 is used, for example, as the recording time of the sensor output signal. The clock of the control unit 103 is an example of a clock unit. In other words, in this embodiment, the clock unit is provided as a function of the control unit 103. The clock unit may be mounted on the control unit board 10 as a circuit separate from the control unit 103.

[0056] The control unit 103 causes the wireless communication unit 107 to wirelessly transmit the sensor output signal and recording time stored in the memory unit 104 to the external device 5. The control unit 103 also causes the wireless communication unit 107 to wirelessly transmit an operating status signal indicating the operating status of the biological monitoring device 1 to the external device 5.

[0057] The wireless communication unit 107 transmits and receives wireless signals via the antenna 106 .

[0058] The external device 5 includes an antenna 501, a wireless communication unit 502, a control unit 503, and an external communication unit 504. The wireless communication unit 502 transmits and receives wireless signals via the antenna 501. The wireless communication unit 107 of the biological monitoring device 1 and the wireless communication unit 502 of the external device 5 perform wireless communication using wireless signals transmitted and received via the respective antennas 106 and 501.

[0059] The control unit 503 wirelessly receives a sensor output signal and a recording time from the biological monitoring device 1. The control unit 503 also wirelessly receives an operating status signal from the biological monitoring device 1. The control unit 503 performs predetermined processing on the received sensor output signal and recording time, and transmits the results of the processing to a predetermined destination via a LAN (Local Area Network) using the external communication unit 504. The control unit 503 also performs predetermined processing in response to the received operating status signal, and transmits the results of the processing to a predetermined destination via a LAN (Local Area Network) using the external communication unit 504.

[0060] 2 is a plan view showing an example of the mounting configuration of the sensor substrate 20 according to this embodiment. As shown in FIG. 2, the sensor substrate 20 has a sensor mounting area 20A, a lead-out area 20B, and a connector area 20C.

[0061] A sensor 20X is mounted on the sensor mounting area 20A. The sensor mounting area 20A is used by being embedded in a living body. The living body is a human or a non-human animal. The sensor mounting area 20A is non-flexible.

[0062] Of the two surfaces of the sensor mounting area 20A, a temperature sensor 201 and a pulse wave sensor 202 are mounted on the surface facing the body when implanted in a living organism. The temperature sensor 201 is mounted on the surface facing the body because it can measure a body temperature closer to core body temperature and is less susceptible to external environmental factors such as room temperature than if it were mounted on the body surface. The pulse wave sensor 202 is mounted on the surface facing the body because it is less susceptible to external light disturbances, improving the signal-to-noise ratio (SNR), and is not affected by the skin than if it were mounted on the body surface. On the other hand, an acceleration sensor 203 is mounted on the surface facing the body when implanted in a living organism. Note that one or more of the temperature sensor 201 and the pulse wave sensor 202 may be mounted on the body surface.

[0063] Furthermore, by embedding the sensor 20X in a living body, it can be more stably positioned at the desired measurement location than if it were placed on the body surface, thereby obtaining more stable measurement results. Furthermore, by embedding the acceleration sensor 203 in a living body, it is less susceptible to the effects of shock and vibration absorption by the skin than if it were placed on the body surface, thereby improving the accuracy of acceleration measurement.

[0064] 2, the edges of the sensor mounting area 20A are chamfered. By chamfering the edges of the sensor mounting area 20A, when the sensor mounting area 20A is embedded in a living body, it is possible to insert the sensor mounting area 20A into the living body smoothly without causing damage to body tissue and without getting caught.

[0065] The lead-out region 20B is configured to include power supply lines P1, P2 and a signal line L1 between the lead-out region 20B and the control unit substrate 10. The lead-out region 20B is used by being disposed across the inside of the living body where the sensor mounting region 20A is embedded and outside of the living body. The lead-out region 20B is flexible.

[0066] A sensor-side connector CN1 is mounted on the connector region 20C. The sensor-side connector CN1 is a connector that mates with the control unit-side connector CN2 of the control unit board 10. The connector region 20C is placed outside the body for use. The connector region 20C is non-flexible. The control unit board 10 is also non-flexible.

[0067] 2, the lead-out region 20B has a narrowed shape with a smaller width than both ends on the sensor mounting region 20A side and the connector region 20C side. The narrowed shape may be formed at any position in the lead-out region 20B. In FIG. 2, an example of the narrowed shape is a narrowed shape with a middle portion that is shorter in width than both ends on the sensor mounting region 20A side and the connector region 20C side.

[0068] 3 is a cross-sectional view showing an example of the substrate configuration of the sensor portion substrate 20 according to this embodiment. The sensor mounting area 20A and the connector area 20C are non-flexible, while the lead-out area 20B is flexible. To form such a substrate, a rigid-flex substrate, which can change the flexibility for each area, is suitable.

[0069] 3, the sensor substrate 20 has a three-layer structure consisting of a rigid substrate K1, a polyimide substrate K2, and a rigid substrate K3. The sensor mounting area 20A uses a non-flexible substrate in which base materials (rigid substrates K1 and K3) such as FR4 are bonded to both sides of the polyimide substrate K2. The lead-out area 20B uses a flexible substrate consisting only of the polyimide substrate K2. The connector area 20C uses the polyimide substrate K2 with a reinforcing plate 210.

[0070] 3, the sensor board 20 can be configured so that only the lead-out region 20B bends without damaging the soldered mounting locations of the sensor 20X or the sensor-side connector CN1. Furthermore, considering that the length of the lead-out region 20B is to be as short as possible to bridge the area from the subcutaneous tissue to the epidermal surface, the lead-out region 20B must have sufficient flexibility. Therefore, it is preferable that the lead-out region 20B be a single-layer polyimide substrate consisting of only the polyimide substrate K2.

[0071] FIG. 4 is a plan view and a cross-sectional view showing an example of the substrate configuration of metal wiring in the lead-out region 20B according to this embodiment. Electrical wiring is required from the sensor mounting region 20A to the connector region 20C using metal wiring. It is preferable that these metal wirings be arranged alternately on the front and back sides of the sensor substrate 20 so that the metal wirings do not overlap in the same portion on the front and back sides. The front surface metal wiring 21 is metal wiring arranged on the front surface of the sensor substrate 20 in the lead-out region 20B. The back surface metal wiring 22 is metal wiring arranged on the back surface of the sensor substrate 20 in the lead-out region 20B. The multiple front surface metal wirings 21 and the multiple back surface metal wirings 22 are arranged alternately on the front and back sides of the sensor substrate 20 so that they do not overlap in the same portion on the front and back sides of the sensor substrate 20 in the lead-out region 20B. It is preferable that the thickness of the metal wiring is sufficiently thin. It is also preferable that the metal wiring does not include solid wiring.

[0072] Here, for comparison with the metal wiring in the lead-out region 20B according to this embodiment, an example will be shown in which the metal wiring is not arranged alternately on the front and back sides so as not to overlap in the same portion on the front and back sides of the sensor portion substrate 20. In the metal wiring shown in Fig. 5, a plurality of front surface metal wirings 121 and a plurality of back surface metal wirings 122 are arranged overlapping in the same portion on the front and back sides of the sensor portion substrate 20. In the metal wiring shown in Fig. 6, a plurality of front surface metal wirings 121 and a back surface metal wiring 123 are arranged overlapping in the same portion on the front and back sides of the sensor portion substrate 20. The back surface metal wiring 123 is a metal pattern that spreads out in a plane.

[0073] In the biological monitoring device 1 according to this embodiment, the metal wiring in the lead-out region 20B is arranged alternately on the front and back of the sensor unit substrate 20 so that the metal wiring does not overlap in the same portion on the front and back of the sensor unit substrate 20, thereby increasing the flexibility of the lead-out region 20B compared to when the metal wiring is arranged so that the metal wiring overlaps in the same portion on the front and back of the sensor unit substrate 20. Note that the metal wiring in the lead-out region 20B may have portions where the metal wiring overlaps in the same portion on the front and back of the sensor unit substrate 20. However, in order to increase the flexibility of the lead-out region 20B, it is preferable that the metal wiring in the lead-out region 20B does not have portions where the metal wiring overlaps in the same portion on the front and back of the sensor unit substrate 20.

[0074] 7 is an explanatory diagram showing an example of use of the biological monitoring device 1 according to this embodiment. As shown in FIG. 7, the sensor mounting region 20A of the sensor unit substrate 20 is embedded in a living body. The lead-out region 20B of the sensor unit substrate 20 is disposed across the living body and outside the living body. The connector region 20C of the sensor unit substrate 20 is disposed outside the living body. The control unit substrate 10 is disposed outside the living body. Therefore, the sensor-side connector CN1 is disposed on the side of the sensor unit substrate 20 that is the control unit substrate 10 disposed outside the living body.

[0075] The portion of the lead-out region 20B extending from inside the body to outside the body is curved to smoothly connect the sensor mounting region 20A embedded in the body to the connector region 20C placed outside the body. The sensor-side connector CN1 of the connector region 20C of the sensor unit substrate 20 is fitted into the sensor-side connector CN1 of the control unit substrate 10 placed outside the body.

[0076] The incisions made in skin A to insert sensor mounting area 20A and lead-out area 20B into the body are sutured or glued with medical adhesive, but the area B where lead-out area 20B exits the body cannot be completely closed. If the incision at area B is large, it will cause significant stress to the body, potentially interfering with the body's normal activities and making the biometric information obtained by sensor 20X ineffective for analyzing the body's ecology. For this reason, it is preferable that the incision at area B be as small as possible.

[0077] The lead-out region 20B according to this embodiment has a constricted shape as shown in FIG. 2, thereby reducing the size of the wound at location B. Because only the power supply lines P1 and P2 and the signal line L1 are mounted in the lead-out region 20B, the minimum width of the constricted shape of the lead-out region 20B can be significantly reduced. By positioning the minimum width portion of this constricted shape at location B, the wound at location B can be minimized, minimizing stress on the living body and suppressing bacterial infection. Furthermore, the constricted shape of the lead-out region 20B can be used as a guide for suturing. This prevents the sensor unit substrate 20 from being suturing out of its intended mounting position.

[0078] Considering application to small animals, the minimum width of the constricted shape of the draw-out region 20B is preferably 5 millimeters (mm) or less. Furthermore, when implanting the sensor mounting region 20A subcutaneously in a typical human or animal, the length of the draw-out region 20B is preferably 3 mm to 10 mm. If the length of the draw-out region 20B is too short, load may be applied to the rigid boards K1 and K3, potentially damaging the mounted components. On the other hand, if the length of the draw-out region 20B is too long, the fixation of the control unit board 10 becomes unstable. Furthermore, since the control unit board 10 is positioned farther away by the length of the draw-out region 20B, the moment of inertia seen from the sensor board 20 increases, increasing the likelihood of the sensor board 20 moving significantly when the living organism moves. This results in a shift in the measurement point of the sensor 20X, making stable measurements impossible.

[0079] Since the sensor substrate 20 is placed inside a living body, it is waterproofed with a parylene coating or the like. Here, the sensor substrate 20 is mounted with only the minimum necessary components, such as the sensor 20X, that need to be implanted inside a living body, so there are fewer irregularities and the coating coverage is improved. This has the effect of forming a high-quality waterproof film.

[0080] On the other hand, since the control unit board 10 is placed outside the living body, excessive waterproofing is not required. This is advantageous when arranging components that require electrical contacts, such as a battery holder and connectors, and the user can replace the battery 101 and connect to an external device 5 using the control unit side connector CN2 without any special fastening.

[0081] The control unit board 10 placed outside the body is equipped with the control unit 103, memory unit 104, wireless communication unit 107, and other components that do not need to be placed inside the body, but since placing the wireless communication unit 107 inside the body would degrade the radio wave transmission characteristics due to radio wave absorption by body tissue, it is preferable to place the wireless communication unit 107 outside the body. Furthermore, since there is less opportunity for the wireless communication unit 107 to come into contact with body fluids than when it is placed inside the body, it is possible to suppress corrosion and prevent short circuits and increased current consumption due to moisture.

[0082] Furthermore, by configuring the control unit substrate 10 to be detachable from the sensor unit substrate 20 using the sensor-side connector CN1 and the control unit-side connector CN2, it is possible to remove only the control unit substrate 10 while leaving the sensor unit substrate 20 attached to the living body. This makes it easy to replace only the control unit substrate 10 when, for example, the battery 101 runs out of capacity or the memory unit 104 runs out of free space. Furthermore, since it is not necessary to remove the sensor unit substrate 20 that has been implanted in the living body from the living body and then implant it again, the burden on the living body is significantly reduced.

[0083] FIG. 8 is a diagram illustrating an example of processing a sensor output signal according to this embodiment. Note that the numerical values ​​shown in FIG. 8 are for convenience of explanation. In the example of FIG. 8, the sensor output signal is a temperature detection signal from the temperature sensor 201. As shown in FIG. 8 (1), the recorded time associated with the sensor output signal and recorded in the memory unit 104 of the biological monitoring device 1 deviates from the actual time. This is due to factors such as the frequency accuracy of the quartz oscillator 105, which generates the fundamental frequency signal that is the basis of the operating frequency of the clock of the control unit 103 of the biological monitoring device 1. While the biological monitoring device 1 itself cannot grasp this time deviation, by periodically transmitting information from the wireless communication unit 107 of the biological monitoring device 1, the external device 5 that receives the information via the wireless communication unit 502 can subsequently correct the time.

[0084] An example of a method for processing a sensor output signal according to this embodiment will be described below. The control unit 103 of the biological monitoring device 1 causes the wireless communication unit 107 to wirelessly transmit a predetermined signal to the external device 5 at a predetermined transmission cycle (10-second cycle, for example) based on the time of its own clock (i.e., the time measured by the clock unit). The control unit 503 of the external device 5 uses its own clock to record the reception time of the predetermined signal wirelessly received by the wireless communication unit 502. The clock of the control unit 503 of the external device 5 is a clock that keeps accurate time using a predetermined time correction method, such as a radio-controlled clock. Based on the record of the reception time of the predetermined signal, the control unit 503 calculates the deviation (time lag) between the "10-second cycle" of the transmission cycle of the biological monitoring device 1 and the 1-second cycle of the time of its own clock.

[0085] The control unit 103 of the biological monitoring device 1 causes the wireless communication unit 107 to wirelessly transmit the sensor output signal and recording time stored in the memory unit 104 to the external device 5. As described above, the recording time is associated with the sensor output signal. The control unit 503 of the external device 5 corrects the time series data of the sensor output signal and recording time wirelessly received by the wireless communication unit 502 based on the time deviation. Therefore, the external device 5 corrects the time series data of the sensor output signal and recording time wirelessly received by the external device 5 based on the reception time of a predetermined signal wirelessly received by the external device 5.

[0086] FIG. 8(2) shows a first correction example of time-series data of a sensor output signal and a recording time. In the first correction example of FIG. 8(2), the recording time is corrected based on a time offset in the time-series data of the sensor output signal and the recording time. This correction method may, for example, directly reflect the time offset in the recording time, or may predict the offset of the recording time depending on changes in the time offset and correct the recording time based on the prediction. Furthermore, if the time offset calculation interval is long, linear interpolation or the like may be used to interpolate the calculation result of the time offset. According to the first correction example of FIG. 8(2), the corrected recording time (corrected time) associated with the sensor output signal is aligned with the actual time.

[0087] 8(3) shows a second example of correction of the time series data of the sensor output signal and the recording time. In the second example of correction of FIG. 8(3), the sensor output signal is corrected based on the time shift in the time series data of the sensor output signal and the recording time. This correction method interpolates the sensor output signal corresponding to the actual time so that the time series data has the same time interval as the recording time.

[0088] FIG. 8(4) shows a third correction example of time series data of a sensor output signal and a recording time. In the third correction example of FIG. 8(4), the time series data of the sensor output signal and the recording time is corrected based on the time difference between the sensor output signal and the recording time. This correction method is a method of deleting or adding pairs of the sensor output signal and the recording time when it is not desired to directly manipulate the recording time and the sensor output signal. For example, if a time difference of one or more steps occurs when rounding the actual time, dummy data is inserted or existing data is deleted, thereby adjusting the time series data to a plausible pair of the time and the sensor output signal.

[0089] The above is a description of an example of a method for processing a sensor output signal.

[0090] Furthermore, instead of immediately capturing the wirelessly transmitted sensor output signals, the external device 5 may read at least some of the sensor output signals stored in the memory unit 104 of the biological monitoring device 1 via a wired or wireless connection after the biological monitoring device 1 has completed measurement. In this case, transmitting all of the sensor output signals wirelessly is undesirable in terms of power consumption and radio wave resource consumption. Therefore, for example, instead of the sensor output signals, an identifier (ID) associated with the sensor output signal may be transmitted in combination with the recording time. In this case, after the biological monitoring device 1 has completed measurement, the external device 5 may correct the recording time based on this association.

[0091] Furthermore, as described above, the control unit 103 may wirelessly transmit a signal (operational status signal) indicating the operating status of the biological monitoring device 1 to the external device 5 via the wireless communication unit 107. The operating status signal may include the voltage of the battery 101, the sensor output signal (or an outline of the sensor output signal), the recording time (or information indicating the time), an identifier of the biological monitoring device 1, etc. By having the external device 5 receive the operating status signal, the operating status of multiple biological monitoring devices 1 can be centrally managed. This allows the user to understand the operating status of the biological monitoring device 1. The operating status of the biological monitoring device 1 may include, for example, when the battery should be replaced, whether the device is operating normally, etc.

[0092] The control unit 103 may also notify the user whether the installation position of the sensor 20X is normal. The notification is made using a sensor output signal. The control unit 103 causes the wireless communication unit 107 to wirelessly transmit the sensor output signal to an external receiver. The receiver presents an installation position evaluation index based on the sensor output signal. The installation position evaluation index is an index for evaluating whether the installation position of the sensor 20X is normal.

[0093] For example, if the sensor 20X is an optical sensor, the installation position evaluation index indicates that the installation position of the sensor 20X is normal when the light intensity value (each of the DC component and AC component) falls within a specific range, and indicates that the installation position of the sensor 20X is abnormal when the light intensity value does not fall within the specific range. For example, if the sensor 20X is an acceleration sensor, the installation position evaluation index indicates that the installation position of the sensor 20X is normal when gravitational acceleration occurs in a specific direction, and indicates that the installation position of the sensor 20X is abnormal when gravitational acceleration does not occur in the specific direction. Sensors 20X whose installation positions are evaluated include temperature sensors, acceleration sensors, optical sensors, pulse wave sensors, blood oxygen saturation (SpO2) sensors, nerve potential sensors, brain potential sensors, and myoelectric potential sensors.

[0094] The receiver is, for example, an external device 5. The receiver may be a dedicated device for notifying the user of the installation position evaluation index. This device communicates wirelessly with the biological monitoring device 1. The receiver may be a smartphone, a tablet, or the like.

[0095] The receiver notifies the user of the installation position evaluation index by displaying the installation position evaluation index on a display device using, for example, text or an image such as a mark. The display device is provided in the receiver. The receiver may notify the user of the installation position evaluation index using light or sound. When light is used to notify the installation position evaluation index, the receiver is provided with, for example, a light-emitting unit including an LED lamp. When sound is used to notify the installation position evaluation index, the receiver is provided with, for example, a speaker. Note that the receiver may notify the user of the installation position evaluation index only when the installation position is abnormal.

[0096] As described above, based on the sensor output signal received by the external receiver, the user can know whether the installation position of the sensor 20X is correct. For example, the user can infer whether the subcutaneously implanted position of the sensor 20X is appropriate, whether the subcutaneously implanted sensor 20X is floating under the skin, whether a foreign object has been introduced and caused the installation position to shift, and whether the sensor 20X is tilted. If the installation position is not correct, the user can correct the installation position of the sensor 20X. This prevents a decrease in the measurement accuracy of the sensor 20X due to such a shift in the installation position.

[0097] Instead of an external receiver receiving the sensor output signal, a notification unit may be provided on the control unit board 10 of the biological monitoring device 1. The notification unit notifies the user whether the installation position of the sensor 20X is normal or not. The notification unit notifies the user of the installation position evaluation index using, for example, light or sound. The notification unit includes, for example, an LED lamp or a speaker.

[0098] The control unit-side connector CN2 of the control unit board 10 of the biological monitoring device 1 according to this embodiment may also be capable of connecting to the external device 5. This allows the control unit board 10 and the external device 5 to be connected via the control unit-side connector CN2. The control unit-side connector CN2 connects the signal line L2 shown in FIG. 1 between the control unit board 10 and the external device 5. The control unit 103, memory unit 104, and wireless communication unit 107 implemented on the control unit board 10 are configured to be operable from the external device 5 connected to the control unit board 10 via the control unit-side connector CN2. Specifically, the control unit 503 of the external device 5 transmits and receives control signals to and from the control unit 103 implemented on the control unit board 10 via the signal line L2. This allows the control unit 503 of the external device 5 to access the control unit 103 implemented on the control unit board 10, and further access the memory unit 104 and wireless communication unit 107 via the control unit 103.

[0099] For example, the control unit 503 of the external device 5 sets measurement conditions and the like for the biological monitoring device 1. For example, the control unit 503 of the external device 5 reads out measurement data (sensor output signals, recording times, etc.) recorded in the storage unit 104 of the biological monitoring device 1 at high speed by wired communication via the signal line L2. For example, the control unit 503 of the external device 5 tests the wireless communication unit 107 of the biological monitoring device 1.

[0100] Furthermore, the sensor-side connector CN1 of the sensor unit board 20 of the biological monitoring device 1 according to this embodiment may also be capable of being connected to the external device 5. This allows the sensor unit board 20 and the external device 5 to be connected via the sensor-side connector CN1. The sensor-side connector CN1 connects the signal line L1 shown in FIG. 1 between the sensor unit board 20 and the external device 5. The sensor 20X mounted on the sensor unit board 20 is configured to be operable by the external device 5 connected to the sensor unit board 20 via the sensor-side connector CN1. Specifically, the control unit 503 of the external device 5 transmits and receives control signals to and from the sensor 20X mounted on the sensor unit board 20 via the signal line L1. This allows the control unit 503 of the external device 5 to perform calibration, self-tests, etc. of the sensor 20X mounted on the sensor unit board 20.

[0101] In this embodiment, an example has been described in which the lead-out region 20B of the sensor unit board 20 and the control unit board 10 are connected by mating the sensor-side connector CN1 and the control unit-side connector CN2 mounted on the connector region 20C. In other words, an example has been described in which the lead-out region 20B and the control unit board 10 are connected via a connector, but this is not limiting. The lead-out region 20B and the control unit board 10 may be connected without a connector. In this case, the lead-out region 20B and the control unit board 10 are directly connected by a power line and a signal line. In this case, the sensor unit board 20 does not need to have the connector region 20C.

[0102] Furthermore, at least one of the sensor portion substrate 20 and the control portion substrate 10 may have a connector region that fits into a connector. When the sensor portion substrate 20 has a connector region (connector region 20C) that fits into a connector (sensor-side connector CN1), the sensor portion substrate 20 is connected to the control portion substrate 10 via the connector, as described in the embodiment. When the control portion substrate 10 has a connector region that fits into a connector (control portion-side connector CN2), the control portion substrate 10 is connected to the lead-out region 20B via the connector. By having at least one of the sensor portion substrate 20 and the control portion substrate 10 have a connector region that fits into a connector, at least one of the sensor portion substrate 20 and the control portion substrate 10 can be easily replaced.

[0103] It should be noted that one or more sensors may be mounted on the sensor unit board 20. That is, it is sufficient that one or more of the temperature sensor 201, pulse wave sensor 202, and acceleration sensor 203 be mounted on the sensor unit board 20. Furthermore, in the above-described embodiment, the temperature sensor 201, pulse wave sensor 202, and acceleration sensor 203 are listed as types of sensors, but various types of sensors other than these may also be applied.

[0104] Furthermore, the lead-out region 20B of the sensor unit substrate 20 may have any shape other than the constricted shape illustrated in FIG. 2 above. FIG. 9 is a plan view showing an example of a mounting configuration of the sensor unit substrate. FIG. 9 shows an example of the shape of the lead-out region 20B of the sensor unit substrate 20. In the example of FIG. 9, the lead-out region 20B has a serpentine shape formed by multiple continuous bends. By shaping the lead-out region 20B in this way, movement of the control unit substrate 10 (e.g., force due to body movement or vibration of a living body, or movement due to a moment) is buffered by the lead-out region 20B and is less likely to be transmitted to the sensor mounting region 20A. This suppresses vibration and positional deviation with respect to the sensor mounting region 20A, thereby preventing noise and artifacts from occurring in the detection signal (sensor output signal) output from the sensor 20X.

[0105] The bent portions may be bent at right angles as in the example shown in FIG. 9 , or may be bent in an arc. In the example shown in FIG. 9 , the lead-out region 20B has multiple constrictions in the direction in which the lead-out region 20B extends. The direction in which the lead-out region 20B extends is the direction from the sensor mounting region 20A to the connector region 20C. In other words, the direction in which the lead-out region 20B extends is the wiring direction of the power supply lines and signal lines. Although the bent portions are continuous in the example shown in FIG. 9 , the bent portions do not have to be continuous, and straight portions may exist between the bent portions. The number of bent portions may be one or more.

[0106] It is preferable to have multiple bends. As described above, the incisions made to insert the sensor mounting region 20A and the lead-out region 20B into the living body are sutured. The multiple bends allow the position of the sensor mounting region 20A and the position of the part to be sutured (referred to as the suture position) to be adjusted during suturing. If the relationship between the position of point B (see FIG. 7 ) where the lead-out region 20B exits the living body and the suture position is not determined in advance, the position of point B may be misaligned with the suture position. If there is only one bend, it may be difficult to adjust the position of point B if the position of point B is misaligned with the suture position.

[0107] Furthermore, both end portions and the periphery of the lead-out region 20B may be linear. By making both end portions and the periphery of the lead-out region 20B linear rather than serpentine, tension applied to each connection portion with the sensor mounting region 20A and the connector region 20C can be reduced, thereby improving the durability of the connection portions.

[0108] When the lead-out region 20B has a meandering shape, the radius of curvature of the curved portion is preferably 1 mm to 2 mm. When the curved portion is curved in an arc, the radius of curvature of the curved portion is the radius of curvature of the arc. When the curved portion is curved at a right angle, the radius of curvature of the curved portion is, for example, the radius of curvature of the arc when the curved portion is approximated by an arc.

[0109] Furthermore, to ensure sufficient stretchability, the period of successive bent portions is preferably small relative to the width of the bent portions. The period of successive bent portions is the distance between adjacent bent portions among the multiple bent portions arranged repeatedly. The width of the bent portion is the length from one end of the bent portion to the other end in a direction perpendicular to the direction in which the multiple bent portions are arranged repeatedly. In other words, the width of the bent portion is the vertical width of the bent portion in Figure 9. For example, the period of successive bent portions is 5 mm, and the width of the bent portion is 8 mm.

[0110] The lead-out region 20B may also have a wedge-like shape. FIG. 10 is a plan view showing an example of the mounting configuration of the sensor unit substrate 20. FIG. 10 shows an example of the shape of the lead-out region 20B of the sensor unit substrate 20. In the example of FIG. 10, the lead-out region 20B has a wedge-like shape on one side. FIG. 11 is a plan view showing an example of the mounting configuration of the sensor unit substrate 20. FIG. 11 shows an example of the shape of the lead-out region 20B of the sensor unit substrate 20. In the example of FIG. 11, the lead-out region 20B has a wedge-like shape on both sides. By making the lead-out region 20B wedge-like, the sensor mounting region 20A is less likely to come out of the living body even if a force directed from the outside is applied to the lead-out region 20B, the connector region 20C, or the control unit substrate 10.

[0111] Additionally, it is preferable that either the sensor mounting area 20A or the connector area 20C, or both the sensor mounting area 20A and the connector area 20C, have a slippage prevention portion. The slippage prevention portion prevents the sensor unit substrate 20 from shifting in position. As described below, the slippage prevention portion is configured with a protrusion, a through-hole, or the like. The slippage prevention portion prevents the subcutaneous position of the sensor mounting area 20A from shifting from its initial position when inserted into the living body, which could result in noise, measurement fluctuation, or malfunction in the sensor output signal. Furthermore, as described above, movement of the connector area 20C due to movement of the control unit substrate 10 placed outside the living body can be transmitted to the sensor mounting area 20A as vibrations and movement. Vibrations and positional shifts relative to the sensor mounting area 20A affect the sensor output signal. Therefore, by providing a slippage prevention portion in at least one of the sensor mounting area 20A and the connector area 20C, movement caused by body movement can be suppressed in both the sensor mounting area 20A and the connector area 20C. Furthermore, if the slippage prevention portion is a protrusion, the protrusion can be inserted into a slit provided in the skin to more firmly fix the position of the sensor unit substrate 20. The protrusion preferably has a size of approximately 1 mm to 2 mm.

[0112] The following describes an example in which the sensor unit substrate 20 has a slippage prevention portion in the sensor mounting area 20A. To prevent the sensor mounting area 20A implanted subcutaneously (i.e., within the living body) from unintentionally slipping out of position, it is possible to utilize the phenomenon of subcutaneous tissue regeneration and adhesion due to natural healing power. For example, the configurations shown in Figures 12 to 14 below can prevent the sensor mounting area 20A implanted subcutaneously from unintentionally slipping out of position.

[0113] FIG. 12 is a plan view and a cross-sectional view showing an example of the mounting configuration of the slippage prevention unit. In the example shown in FIG. 12, the slippage prevention unit has protrusions 31. Three protrusions 31 are provided on each of the three surfaces that form the outer periphery of the sensor mounting area 20A. In other words, the slippage prevention unit is located on the outer periphery of the sensor mounting area 20A. The protrusions 31 protrude from the surfaces in a direction toward the outside of the sensor mounting area 20A. The height of the sensor mounting area 20A and the height of the protrusions 31 are approximately equal. The top surface of the protrusions 31 and the top surface of the sensor mounting area 20A are in the same plane. The bottom surface of the protrusions 31 and the bottom surface of the sensor mounting area 20A are in the same plane.

[0114] Because the protrusions 31 catch on the subcutaneous tissue, the position of the sensor mounting area 20A is less likely to shift. Furthermore, because the subcutaneous tissue regenerates according to the shape of the sensor mounting area 20A, the position of the sensor mounting area 20A is less likely to shift after healing. By providing the slippage prevention portion on the outer periphery of the sensor mounting area 20A, a large moment is less likely to be generated compared to when the slippage prevention portion is provided on the inner periphery of the sensor mounting area 20A, and therefore the sensor mounting area 20A is less likely to rotate within the top surface (or bottom surface) of the sensor mounting area 20A.

[0115] The misalignment prevention portion may have a recess (indentation). For example, one or more of the protrusions 31 shown in FIG. 12 may be realized by a recess provided at an edge of the base shape of the sensor mounting area 20A. The misalignment prevention portion may also be located at a corner that constitutes the outer periphery of the sensor mounting area 20A.

[0116] FIG. 13 is a plan view and a cross-sectional view showing an example of the mounting configuration of the slippage prevention unit. In the example shown in FIG. 13, the slippage prevention unit has protrusions 32. The protrusions 32 protrude from each of the front and back surfaces of the sensor mounting area 20A in a direction toward the outside of the sensor mounting area 20A. In other words, the slippage prevention unit is disposed approximately perpendicular to the interface between the epidermis and the subcutaneous tissue. Four protrusions 32 are provided on each of the front and back surfaces of the sensor mounting area 20A. In other words, a total of eight protrusions 32 are provided. The protrusions 32 are provided near the four corners of each of the front and back surfaces of the sensor mounting area 20A. Since the subcutaneous tissue regenerates according to the shape of the protrusions 32, after healing, the position of the sensor mounting area 20A is less likely to shift in a direction approximately parallel to the surface of the epidermis.

[0117] The slippage prevention unit does not have to be disposed substantially perpendicular to the interface between the epidermis and the subcutaneous tissue. The slippage prevention unit may be disposed tilted at a predetermined angle from a direction substantially perpendicular to the interface between the epidermis and the subcutaneous tissue.

[0118] FIG. 14 shows a plan view and a cross-sectional view illustrating an example of the mounting configuration of the slippage prevention unit. In the example shown in FIG. 14, the slippage prevention unit has a hole. The hole shape is, for example, a circle. In the example shown in FIG. 14, two through-holes 33 are provided so as to penetrate from the front surface to the back surface of the sensor mounting area 20A. After the sensor mounting area 20A is inserted into the living body, the subcutaneous tissue that regenerates according to the shape of the through-holes 33 adheres to the through-holes 33, making it difficult for the sensor mounting area 20A to shift position. Providing holes as slippage prevention units reduces costs compared to providing protrusions, by the amount of material cost for the protrusions. Furthermore, holes are easier to manufacture than protrusions. The shape of the holes in the slippage prevention unit is not limited to a circle. The shape of the holes may be any shape, such as a rectangle. The holes in the slippage prevention unit may also be non-through holes or recesses.

[0119] The slippage prevention portion may also have protrusions and holes. For example, one or more of the protrusions 32 shown in FIG. 13 may be replaced with non-through holes or depressions. One or more of the through-holes 33 shown in FIG. 14 may be replaced with protrusions. That is, the slippage prevention portion may be configured as irregularities provided on the base of the sensor mounting area 20A. The subcutaneous tissue regenerates according to the shape of these irregularities. In the early stage after the sensor mounting area 20A is inserted into the living body, the protrusions mainly prevent the sensor mounting area 20A from shifting. As the subcutaneous tissue regenerates over time, the regenerated subcutaneous tissue adheres to the holes after healing. Therefore, after healing, the adhesion to the holes increases the effectiveness of preventing the sensor mounting area 20A from shifting.

[0120] The positional deviation of the sensor mounting area 20A is, in other words, a deviation in the installation position of the sensor 20X. The positional deviation of the sensor mounting area 20A includes a positional deviation in a direction substantially parallel to the surface of the skin and a deviation due to rotation within a plane substantially parallel to the surface of the skin.

[0121] As described above, the sensor unit substrate 20 has a plurality of anti-slip portions. The plurality of anti-slip portions of the sensor unit substrate 20 may be configured with one or more of the various shapes described above (such as protrusions and holes). The sensor unit substrate 20 may also have only one anti-slip portion. It is preferable that a sufficient number of anti-slip portions be provided in appropriate positions in the sensor mounting area 20A to prevent misalignment of the sensor mounting area 20A, provided that the anti-slip portions do not overlap with the positions where the sensors 20X are mounted in the sensor mounting area 20A and the external shape of the sensor mounting area 20A itself does not become too complex.

[0122] When the sensor substrate 20 has multiple slip prevention portions, the sensor substrate 20 preferably has the multiple slip prevention portions in positions that do not overlap when viewed from above. For example, in the examples shown in Figures 12, 13, and 14 described above, the multiple slip prevention portions are provided in positions that do not overlap when viewed from above the sensor mounting area 20A. When the multiple slip prevention portions are provided in positions that do not overlap when viewed from above the sensor mounting area 20A, rotation of the sensor mounting area 20A about one slip prevention portion in a plane viewed from above the sensor mounting area 20A is prevented by another slip prevention portion. In other words, the multiple slip prevention portions can prevent rotation of the sensor mounting area 20A in a plane viewed from above the sensor mounting area 20A.

[0123] The slippage prevention portion may also be a surface-treated portion for preventing displacement of the sensor mounting area 20A in vivo. For example, the slippage prevention portion may be minute irregularities provided on at least a portion of the surface of the sensor mounting area 20A. The minute irregularities are irregularities whose height or depth from the surface of the sensor mounting area 20A is, for example, 10 micrometers to less than 1 millimeter. The minute irregularities increase the resistance of the surface of the sensor mounting area 20A, preventing displacement of the sensor mounting area 20A.

[0124] The slippage prevention portion may also be a portion where at least a portion of the surface of the sensor mounting area 20A has been surface-treated with a chemical that promotes adhesion with biological tissue. For example, the surface of the sensor mounting area 20A may be coated with a cyanoacrylate-based, biopolymer-aldehyde-based, or fibrin-based bioadhesive material; a hydrogel material made of collagen, hyaluronic acid, alginic acid, chitosan, or silk fibroin; a bioactive ceramic material such as hydroxyapatite, bioglass, calcium phosphate, or carbonate-containing apatite; or a porous material. The chemical that promotes adhesion with biological tissue makes the surface of the sensor mounting area 20A more likely to adhere to biological tissue, thereby increasing the effectiveness of fixation through adhesion.

[0125] Furthermore, the optical properties of the transmission windows of optical sensors such as the temperature sensor 201 and pulse wave sensor 202 may change due to adhesion of biological tissue, potentially reducing the sensitivity of the optical sensor. Therefore, it is effective not to apply chemical coatings to areas where the sensitivity of the optical sensor may be reduced. Alternatively, an anti-adhesion agent may be applied to the periphery of the sensor 20X in the sensor mounting area 20A. Examples of the anti-adhesion agent include surface-modified gelatin, oxidized cellulose, a gelling agent made of sodium hyaluronate or carboxymethyl cellulose, a dextrin-based anti-adhesion material, or a bioinert ceramic material such as alumina. The anti-adhesion agent can prevent a decrease in the sensitivity of the optical sensor due to adhesion of biological tissue.

[0126] The slippage prevention portion may also be made of a bioabsorbable material. For example, protrusions serving as the slippage prevention portion may be made of a bioabsorbable material. If the slippage prevention portion is made of a bioabsorbable material, after the sensor mounting area 20A is inserted into the body, the slippage prevention portion is absorbed by the body and disappears, and biological tissue regenerates in the area where the slippage prevention portion was provided. The sensor mounting area 20A is fixed by the regenerated biological tissue, thereby preventing the sensor mounting area 20A from shifting out of position. If the slippage prevention portion is made of a bioabsorbable material, the slippage prevention portion prevents the sensor mounting area 20A from shifting out of position in the early stages after the sensor mounting area 20A is inserted into the body. After the subcutaneous tissue heals, the biological tissue regenerates in the area where the slippage prevention portion was provided, thereby enhancing the effectiveness of preventing the sensor mounting area 20A from shifting out of position. Therefore, if the slippage prevention portion is made of a bioabsorbable material, the same effect as the effect when the slippage prevention portion has both protrusions and holes described above is achieved. Furthermore, since the bioabsorbable material is absorbed into the living body, the volume that the sensor mounting area 20A occupies inside the living body can be reduced, and the burden on the living body in which the sensor is embedded can be reduced.

[0127] The sensor mounting area 20A may also have a rounded shape on the side opposite the draw-out area 20B. As shown in Fig. 15, the sensor mounting area 20A is inserted into a living body in the direction indicated by arrow Y1. The end R1 shown in Fig. 15 is the portion of the sensor mounting area 20A that faces the draw-out area 20B. By making the end R1 rounded, it becomes easier to insert the sensor mounting area 20A into a living body.

[0128] The sensor mounting area 20A may also have a slip-out prevention structure on the draw-out area 20B side to prevent the sensor mounting area 20A from slipping out of the living body. The anchor 34 shown in FIG. 16 is an example of a slip-out prevention structure. The anchor 34 is provided at the end R2 of the sensor mounting area 20A, which is the portion of the sensor mounting area 20A that faces the draw-out area 20B. The anchor 34 may be provided, for example, at the end of the sensor unit substrate 20 that faces the control unit substrate 10. The anchor 34 is provided at the end so that it extends from the end in a direction opposite to the direction in which the sensor mounting area 20A is inserted into the living body. The anchor 34 may also be provided at a portion of the sensor unit substrate 20 closer to the center than the end on the control unit substrate 10 side. The slip-out prevention structure makes it difficult for the sensor mounting area 20A to slip out of the living body, even when a force directed from the outside of the living body is applied to the draw-out area 20B, the connector area 20C, or the control unit substrate 10.

[0129] The sensor substrate 20 may also have a pressure mechanism that presses the sensor mounting area 20A toward the inside of the living body. In the example shown in FIG. 17 , the lead-out area 20B of the sensor substrate 20 is formed by a rigid-flexible substrate 35, and the control unit substrate 10 is fixed to the skin A by a fixing portion 36. The fixing portion 36 is, for example, an adhesive tape such as surgical tape. The fixing portion 36 is attached to the surface of the control unit substrate 10 opposite the skin A so that the fixing portion 36 covers the control unit substrate 10, thereby fixing the control unit substrate 10 to the skin A. The rigid-flexible substrate 35 and the fixing portion 36 are an example of a pressure mechanism. The repulsive force of the rigid-flexible substrate 35 urges the sensor mounting area 20A toward the living body. The urging force of the rigid-flexible substrate 35 can prevent the sensor mounting area 20A from floating up. Therefore, the sensor 20X mounted in the sensor mounting area 20A can be stably held in the desired measurement position, resulting in stable measurement results.

[0130] The method by which the fixing unit 36 ​​fixes the control unit substrate 10 is not limited to the example shown in FIG. 17 . As another example, the fixing unit 36 ​​may be attached to the surface of the control unit substrate 10 facing the skin A using double-sided tape, thereby fixing the control unit substrate 10 to the skin A. The fixing unit 36 ​​may also be a member other than adhesive tape, such as a band. If the control unit substrate 10 is sufficiently heavy, the fixing unit 36 ​​may be omitted from the pressure mechanism. For example, if it is expected that the part of the living body to which the biological monitoring device 1 is attached will not move much while the biological monitoring device 1 is in operation, the control unit substrate 10 may be fixed to the skin A by its own weight. In this case, the control unit substrate 10 has a weight large enough to prevent it from floating off the skin A due to the repulsive force of the rigid-flex substrate 35, but small enough to avoid applying excessive pressure to the skin A.

[0131] As described above, according to this embodiment, it is possible to obtain the effect of reducing the burden on the living body in which the sensor is implanted.

[0132] Although the present invention has been described above using the embodiments, the present invention is not limited to these embodiments, and various modifications and substitutions can be made without departing from the spirit of the present invention. The configurations described in the above-described embodiments and examples may be combined.

[0133] 1...biometric monitoring device, 10...controller board, 20...sensor board, 101...battery, 102...power distribution unit, 103...controller, 104...storage unit, 105...quartz oscillator, 106...antenna, 107...wireless communication unit, 201...temperature sensor, 202...pulse wave sensor, 203...acceleration sensor, 5...external device, 501...antenna, 502...wireless communication unit, 503...controller, 504...external communication unit

Claims

1. a sensor unit substrate on which one or more sensors are mounted; a control unit board on which a power supply, a control unit, and a storage unit are mounted, The sensor unit substrate has a sensor mounting area in which the sensor is mounted and an extraction area including a power line and a signal line between the sensor mounting area and the control unit substrate, and the sensor mounting area is embedded in a living body. Biometric monitoring devices.

2. The sensor board has a displacement prevention portion that prevents the sensor board from being displaced in the sensor mounting area, The slippage prevention portion has a protrusion. The biological monitoring device according to claim 1 .

3. The sensor unit substrate has a displacement prevention portion that prevents the sensor unit substrate from being displaced in the sensor mounting area, The slip prevention portion has a hole. The biological monitoring device according to claim 1 .

4. The sensor unit substrate has a displacement prevention portion that prevents the sensor unit substrate from being displaced in the sensor mounting area, The slippage prevention portion is a portion on at least a part of the surface of the sensor portion substrate that has been surface-treated with a chemical substance that promotes adhesion with biological tissue. The biological monitoring device according to claim 1 .

5. The sensor unit substrate has a displacement prevention portion that prevents the sensor unit substrate from being displaced in the sensor mounting area, The displacement prevention portion is a fine unevenness provided on at least a part of the surface of the sensor portion substrate. The biological monitoring device according to claim 1 .

6. the sensor mounting area has a slip-out prevention structure on the pull-out area side that prevents the sensor mounting area from slipping out of the living body; The biological monitoring device according to claim 1 .

7. The sensor mounting area has a rounded shape on the side opposite to the pull-out area. The biological monitoring device according to claim 1 .

8. the sensor unit substrate is configured such that the sensor is mounted on one of the two surfaces of the sensor mounting area that faces the body when the sensor unit substrate is implanted in a living body; The biological monitoring device according to claim 1 .

9. The sensor unit substrate has a chamfered edge in the sensor mounting area. The biological monitoring device according to claim 1 .

10. It also has a clock section, a wireless communication unit is further mounted on the control unit board; the storage unit stores the sensor output signal in association with a recording time, which is the time measured by the clock unit; the control unit causes the wireless communication unit to wirelessly transmit a predetermined signal to an external device at a predetermined transmission period based on the time measured by the clock unit; the control unit causes the wireless communication unit to wirelessly transmit the sensor output signal stored in the storage unit and the recording time associated with the sensor output signal to the external device; the external device corrects the time series data of the sensor output signal and the recording time wirelessly received by the external device based on the reception time of the predetermined signal wirelessly received by the external device. The biological monitoring device according to claim 1 .

11. The control unit notifies the user whether the installation position of the sensor is normal or not. The biological monitoring device according to claim 1 .

12. the sensor mounting area and the control unit substrate are non-flexible; the withdrawal region is flexible; The biological monitoring device according to claim 1 .

13. the sensor unit substrate is arranged such that the draw-out region extends across the in vivo and ex vivo regions; The control unit substrate is placed outside the living body. The biological monitoring device according to claim 1 .

14. The pull-out region has a constricted shape. The biological monitoring device according to claim 1 .

15. The pull-out region has a serpentine shape formed by a plurality of bends. The biological monitoring device according to claim 1 .

16. The pull-out region has a wedge shape. The biological monitoring device according to claim 1 .

17. The sensor unit substrate has a pressurizing mechanism that presses the sensor mounting area toward the inside of the living body. The biological monitoring device according to claim 1 .