JP7085866B2 - Medical device system - Google Patents

Description

The present invention relates to a medical device system that notifies the state of a medical device placed on the body surface of a living body.

For example, Patent Document 1 discloses a medical device system that detects biological information by a medical device (detection device) placed on the body surface of a living body and transmits the biological information to an external receiver. The receiver appropriately processes and displays the received biological information, and when an abnormality information or the like is received from the medical device or a communication failure occurs, the receiver notifies the user of the medical device of an alarm via the receiver.

Japanese Patent No. 4870075

By the way, although the receiver as described above is usually carried by the user, it is not carried by the user, for example, when the user plays sports or when the user takes a bath. That is, the receiver may be placed away from the medical device.

Therefore, the user cannot confirm the biometric information while the receiver is away from the medical device. Further, when an abnormality or an alert occurs in the medical device, the user may not notice the warning notified from the receiver.

The present invention has been made to solve the above problems, and an object of the present invention is to provide a medical device system capable of notifying a user of the state of a medical device by a simple configuration.

In order to achieve the above object, the medical device system according to the present invention includes a medical device placed on the body surface of a living body, a notification device that performs notification based on a signal or power output from the medical device, and a notification device. A fixture for fixing the notification device to the medical device and an information processing device for wirelessly communicating biometric information between the notification device are provided, and the notification device can be removed from the medical device by the fixture. The medical device has a detection unit for detecting the biological information of the living body and a control unit for acquiring the occurrence of the biological information or an abnormality related to the medical device. , The arrangement of the notification device in the vicinity of the medical device is monitored, and along with the arrangement of the notification device, information indicating that the notification device is arranged is transmitted to the information processing device, and the medical device of the medical device. It is characterized in that the notification of the notification device is performed based on the information on the occurrence of the abnormality in a state where the notification device is arranged at a nearby position .

In this case, it is preferable that the notification device is attached to the cover as the fixing tool and is attached to the medical device to be fixed to the body surface.

Then, the information processing device notifies the occurrence information of the abnormality in the non-attached state of the notification device, while monitoring the arrangement of the notification device in the vicinity of the medical device, and the attachment state of the notification device. Therefore, it is advisable to stop the notification of the occurrence information of the abnormality.

Further, it is preferable that the medical device has a battery for supplying electric power to an internal electric component, and the notification device can be notified by being supplied with electric power from the battery in a state of being placed on the body surface. ..

The medical device and the notification device may have a wireless power supply structure that wirelessly supplies power to the notification device from the battery.

For example, it is preferable that the notification device has a buzzer for notifying biological information or information on the occurrence of an abnormality related to the medical device with a warning sound.

Further, for example, the notification device may have a vibrator for notifying biological information or information on the occurrence of an abnormality related to the medical device by vibration.

Alternatively, the notification device may have a monitor that displays biological information or information on the occurrence of an abnormality related to the medical device. Further, the cover has an adhesive layer, and the adhesive layer includes a first portion to which the notification device is adhered and a second portion to be attached to the body surface, and the adhesive of the second portion. The force may be stronger than the adhesive force of the first portion.

According to the present invention, the medical device system and the notification device can fix the notification device at a position near the medical device as needed by the user, and the notification device can notify the state of the medical device. .. For example, even if the information processing device that communicates with the medical device is located away from the medical device, the notification device notifies when an abnormality in biological information is detected or when a communication failure occurs with the outside. This makes it possible for the user to recognize the occurrence of an abnormality. In particular, in a medical device system, a notification device can be easily placed on the body surface by using a cover. In addition, in the medical device system, the notification device is not attached at normal times, so that the weight and life of the medical device can be shortened, the indwelling state can be maintained well, and biometric information, etc. can be sent to the external information processing device. Signal can be transmitted.

It is a perspective view which shows the whole structure of the medical device system which concerns on 1st Embodiment of this invention. It is a block diagram which shows the structure of a medical device system. FIG. 3A is a side sectional view showing the configuration of the notification device. FIG. 3B is a cross-sectional view taken along the line IIIB-IIIB of FIG. 3A. FIG. 4A is a first side sectional view showing a procedure for arranging the notification device in the detection device. FIG. 4B is a second side sectional view showing a procedure following FIG. 4A. It is a block diagram which shows the functional part of a medical device system. FIG. 6A is a flowchart showing a procedure for notifying an abnormal glucose level when a notifying device is attached to the detection device. FIG. 6B is a flowchart showing a procedure for notifying a communication abnormality. FIG. 7A is a first side sectional view showing a procedure for arranging the notification device of the medical device system according to the second embodiment in the detection device. FIG. 7B is a second side sectional view showing a procedure following FIG. 7A. FIG. 8A is a first side sectional view showing a procedure for arranging the notification device of the medical device system according to the third embodiment in the detection device. FIG. 8B is a second side sectional view showing a procedure following FIG. 8A. FIG. 9A is a side sectional view showing a notification device of the medical device system according to the fourth embodiment. FIG. 9B is a side sectional view showing a notification device of the medical device system according to the fifth embodiment.

Hereinafter, preferred embodiments of the present invention will be given and will be described in detail with reference to the accompanying drawings.

[First Embodiment]
As shown in FIG. 1, the medical device system 10A according to the first embodiment of the present invention has a detection device 12 (medical device) placed on the body surface of a user (living body) who is a patient, and the detection device 12 Detects the biometric information of the user. The biological information detected by the detection device 12 is normally transmitted to the information processing device 14 carried by the user. The information processing apparatus 14 stores the transmitted biological information and provides the biological information to the user in an appropriate format under the operation of the user.

The biological information handled by the medical device system 10A is not particularly limited, and examples thereof include glucose level, blood glucose level, ketone body, blood pressure, heart rate, body temperature, electrocardiogram, brain wave, respiratory state, and blood oxygen saturation. In the present embodiment, the detection device 12 that obtains the glucose value of the user as biological information will be typically described.

That is, the medical device system 10A is configured as a system for CGM (Continuous Glucose Monitoring) in which a sensor is placed on the body surface and the glucose level in the interstitial fluid of the user is detected at predetermined intervals. The system for CGM monitors fluctuations in glucose levels in the interstitial fluid of the user, so that, for example, in the treatment of diabetes, doctors and the like can take a policy tailored to the condition of each individual patient. Further, the medical device system 10A may be configured to automatically administer a drug such as insulin based on the glucose value detected by the detection device 12 by interlocking with a drug administration device (not shown).

In this type of medical device system 10A, when the user performs sports, bathing, etc., the information processing device 14 is placed at a position farther from the detection device 12 than in normal times, so that the detection device 12 causes an abnormality or the like. Even if it is detected, it becomes difficult for the user to notice. Therefore, the medical device system 10A according to the present embodiment has a notification device 16A and a cover 18 as a fixing tool for fixing the notification device 16A, and the user installs the notification device 16A on the body surface as needed. It is configured to notify the state of the detection device 12. Hereinafter, the medical device system 10A will be described.

The detection device 12 of the medical device system 10A includes a detection main body 20 (detection unit), a transmitter unit 22 attached to the detection main body 20 to transmit a glucose value to the outside, and a detection main body 20 and a transmitter unit 22. It has an indwelling portion 24 to be indwelled on the table.

The detection main body 20 has a sensor-side housing 26 that is sufficiently smaller than the transmitter 22. The detection body unit 20 is connected to the transmitter unit 22 and includes a sensor unit 30 that projects from the surface of the sensor-side housing 26 facing the patient.

The sensor unit 30 is inserted into the user's body with the detection device 12 indwelled in the user. For example, the sensor unit 30 is incorporated in an insertion device (not shown) before insertion, and is punctured and placed in the body from the user's body surface under the operation of the insertion device. In the indwelling state, the sensor unit 30 detects information related to glucose contained in the interstitial fluid and sends it to the detection circuit unit 28 of the transmitter unit 22 based on a predetermined measurement principle.

As an example of the measurement principle, there is an enzyme electrode method for measuring glucose contained in the subcutaneous interstitial fluid. In this case, the sensor unit 30 is configured as an electrode that detects electrons generated by reacting glucose in the interstitial fluid with an enzyme as an amount of electric current. The detection circuit unit 28 detects a signal according to the glucose concentration in the interstitial fluid. The measurement principle is not limited to the enzyme electrode method, and may be an affinity sensor using a glucose-binding protein or phenylboronic acid, and the detection method may be an optical signal.

As shown in FIGS. 1 and 2, the transmitter unit 22 has a transmitter-side housing 32 that covers the detection body unit 20 and is attached to the indwelling unit 24. In the transmitter side housing 32, the power of the detection circuit unit 28, the A / D circuit 34 connected to the detection circuit unit 28, the communication module 36 that performs wireless communication with the outside, the battery 38, and the battery 38 is transmitted to the notification device 16A. A power feeding unit 40 for supplying power and a control unit 42 for controlling the operation of the detection device 12 are provided. The transmitter-side housing 32 is designed to be thin and small so that the user can comfortably wear it. Specifically, the height from the body surface is preferably set to 1 cm or less, preferably less than 5 mm. Therefore, the transmitter unit 22 is designed to mount the minimum components necessary for detecting biometric information, and does not include a display (display device) or an alert unit.

The A / D circuit 34 converts the analog signal received from the detection circuit unit 28 into a digital signal.

The communication module 36 constructs a wireless communication line with an external device (information processing device 14), and performs information communication including biometric information and device information under the control of the control unit 42. For example, examples of wireless communication line standards include wireless PANs such as Bluetooth (registered trademark) and ZigBee (registered trademark), and wireless LANs such as Wi-Fi.

The battery 38 is, for example, a rechargeable and dischargeable secondary battery, and supplies electric power to the detection device 12 (each electric component (including the power supply unit 40) of the detection main body 20 and the transmitter 22). The battery 38 may be a primary battery. The sensor unit 30 and the transmitter unit 22 are connected so as to be able to supply electric power and transmit / receive signals via connection terminals (not shown).

The power feeding unit 40 constitutes one of the wireless power feeding structures 44 that wirelessly supplies electric power to the notification device 16A by supplying electric power based on the control of the control unit 42. Specifically, the feeding portion 40 is provided on the upper part (opposite side of the body surface) of the transmitter side housing 32, and is formed in a shape (primary coil for electromagnetic induction) in which metal wires are arranged in a coil shape (primary coil for electromagnetic induction). See also FIG. 3B). A conversion unit (not shown) that converts DC power into AC power is provided between the battery 38 and the power supply unit 40, and the power supply unit 40 generates magnetism (electromagnetic induction) according to the power supply of the battery 38 to notify the user. This magnetism is applied to the device 16A.

As shown in FIG. 2, the detection body unit 20 is detachably connected to the transmitter unit 22. The detection circuit unit 28, in the connected state with the sensor unit 30, interlocks with the control unit 42 described later to acquire a signal corresponding to the glucose concentration obtained from the sensor unit 30. The acquired signal is sent to the A / D circuit 34 of the transmitter unit 22.

The control unit 42 has a processor and a memory (not shown). The control unit 42 controls signal detection according to the glucose concentration by the detection circuit unit 28 by the processor reading and executing a detection program (not shown) stored in the memory. For example, the control unit 42 performs signal detection according to the glucose concentration at predetermined timings, digitizes the signal corresponding to the detected glucose concentration by the A / D circuit 34 and stores it in the memory, and also stores the communication module 36. It is controlled and a signal value corresponding to the digitized glucose concentration is transmitted to the information processing apparatus 14. At this time, the transmitted signal is converted into a glucose value and displayed by the arithmetic unit in the information processing apparatus 14. Alternatively, the control unit 42 may be provided with a calculation unit (not shown) that noise-processes the signal digitized by the A / D circuit 34 and converts it into a glucose value. In this case, the glucose value converted by the calculation unit is transmitted to the information processing apparatus 14 via the communication module 36.

Then, in the control unit 42 according to the present embodiment, the notification device 16A is arranged in the vicinity of the detection device 12, and the glucose level is abnormal (hyperglycemia, hypoglycemia), the abnormality at the time of measurement, or the information processing device 14. When an abnormality in the communication of the above occurs, the power supply to the power feeding unit 40 is controlled. That is, based on the occurrence of an abnormality, the control unit 42 supplies the power of the battery 38 to the primary coil of the power feeding unit 40 to cause electromagnetic induction, thereby supplying power to the notification device 16A and outputting a warning sound. The control for notifying the alert by the notifying device 16A will be described in detail later.

Returning to FIG. 1, the indwelling unit 24 fixes the detection main body unit 20 and the transmitter unit 22 together to the body surface of the living body. For example, the indwelling portion 24 has flexibility and is configured as a sticker 24a for fixing the facing surface of the body surface of the transmitter side housing 32. The detection main body 20 is arranged inside the transmitter 22 and the sticker 24a in a fixed state, so that the detection main body 20 is maintained on the body surface. As the sticker 24a for sticking, it is preferable to apply a sticker that exerts strong and continuous adhesive force to the body surface in order to indwell the detection device 12 for a long period of time. The indwelling portion 24 has a frame (not shown) that integrally holds the detection main body portion 20 and the transmitter portion 22, and the frame and the sticker 24a may be fixed to the frame.

On the other hand, the information processing apparatus 14 is configured as a dedicated receiver for a system for CGM, and a computer having a processor 14a, a memory 14b, and an input / output interface (input / output I / F 14c) is provided inside the information processing apparatus 14. The information processing device 14 can be applied not only to a dedicated receiver but also to various devices capable of information communication with the detection device 12. For example, the information processing device 14 can be a portable information terminal such as a smartphone, a PDA, or a wearable computer, or a laptop computer, a tablet terminal, or the like.

A communication module 14d capable of wireless communication with the detection device 12 is connected to the input / output I / F 14c of the information processing device 14. Further, the information processing apparatus 14 has an operation unit 14e (button or the like) for the user to operate, and a display unit 14f (monitor) for displaying the glucose value or the like in an appropriate format. The operation unit 14e may be a touch screen displayed on the display unit 14f instead of the soft keys.

The information processing device 14 normally exists around the user to construct a wireless communication line with the detection device 12 and automatically acquire the glucose value from the detection device 12. The information processing apparatus 14 stores the acquired glucose value and displays it on the display unit 14f under the operation of the operation unit 14e by the user, for example. In addition to displaying the glucose value, the information processing apparatus 14 has an abnormality in the glucose value (hereinafter, also referred to as an abnormality in the glucose value) and an abnormality in the communication state between the detection device 12 and the information processing apparatus 14 (communication failure). : Hereinafter, when a communication abnormality occurs), information on the occurrence of the abnormality is displayed (notified). Since the detection device 12 has a structure in which the transmitter side housing 32 is thin and small and does not include a display device or an alarm unit, information on the occurrence of each glucose value abnormality or communication abnormality is normally transmitted to the information processing device 14. Through the message display, buzzer sound, light, vibration, etc., the user is notified.

The notification device 16A of the medical device system 10A is arranged on the upper part of the detection device 12 according to the user's need (intention). The notification device 16A is attached on the body surface by being integrally covered with the detection device 12 by a cover 18 as a fixing tool having adhesive strength.

As shown in FIG. 3A, the notification device 16A has a notification device side housing 46, and includes a power receiving unit 48, a circuit board 50, and a notification member 52 inside the notification device side housing 46.

The notification device-side housing 46 has a thin box shape for accommodating internal parts, and is formed smaller than the transmitter unit 22 (see also FIG. 4B). The notification device-side housing 46 is arranged so as to fit inside the upper surface (the surface opposite to the facing surface of the body surface) of the transmitter-side housing 32 in a plan view. The transmitter-side housing 32 and the notification device-side housing 46 may have a structure capable of positioning and fixing each other's positions. For example, the notification device 16A can be easily positioned on the upper surface of the detection device 12 by forming a recess (not shown) that matches the shape of the notification device side housing 46 on the upper surface of the transmitter side housing 32. The recesses may be flat, grooved, or dotted, and it is preferable that a plurality of recesses are provided.

The power receiving unit 48 of the notification device 16A is a portion (the other side of the wireless power feeding structure 44) that receives power wirelessly from the power feeding unit 40 of the detecting device 12. The power receiving unit 48 is provided on one side (the side facing the transmitter unit 22) of the notification device side housing 46. As shown in FIG. 3B, the power receiving unit 48 is formed in a shape in which metal wires are arranged in a coil shape (secondary coil for electromagnetic induction), and electromagnetic induction is performed based on the magnetism of the feeding unit 40 of the transmitter unit 22. Then, it receives power. The power supply method in the wireless power supply structure 44 is not limited to electromagnetic induction, and a resonance method, an electric field coupling method, or the like can be adopted.

As shown in FIGS. 3A and 3B, an electronic component is printed on the circuit board 50, a power receiving unit 48 is mounted on one surface thereof, and a notification member 52 is mounted on the other surface. The circuit board 50 may supply the AC power of the thin plate-shaped power receiving unit 48 to the notification member 52 as it is, or has a conversion unit (not shown) that converts the AC power into DC power, and supplies power to the notification member 52. May be good.

The notification member 52 is configured as a buzzer that outputs a predetermined warning sound, and sounds when power is supplied via the circuit board 50. The user who owns the notification device 16A can recognize that the detection device 12 has detected an abnormality by listening to the warning sound from the notification device 16A even when the information processing device 14 is away. The notification device 16A may be configured such that the circuit board 50 is provided with a control unit (not shown) and the notification member 52 can output a plurality of types of sounds under the control of the control unit. As a result, the control unit can select a sound according to the type of detected abnormality and notify the user.

Further, as shown in FIGS. 1 and 4A, the cover 18 covering the notification device 16A is flexible and is formed sufficiently larger than the planar shape of the detection device 12 and the notification device 16A. The upper surface of the notification device-side housing 46 is a fixed portion 46a to which the cover 18 is attached (fixed).

The cover 18 covers the detection device 12 and the notification device 16A together on the body surface, and the notification device 16A is positioned and held on the detection device 12 by being attached to the body surface around the cover 18. The cover 18 is formed to be transparent or translucent, for example, so that it can be easily confirmed from the outside even if the notification device 16A is covered. It is preferable that the cover 18 has a mark (not shown) printed on the place where the detection device 12 is scheduled to be attached.

The adhesive layer 54 is coated on the surface (body surface facing surface) of the cover 18 facing the detection device 12 and the notification device 16A. The adhesive layer 54 is set so that the adhesive force is weak in the central portion 54a to be adhered to the notification device 16A, and the adhesive force of the peripheral portion 54b to be attached to the body surface is stronger than the adhesive force of the central portion 54a. It is good. As a result, when the notification device 16A is fixed on the body surface, the peripheral portion 54b can be strongly attached on the body surface while the notification device 16A is attached to the central portion 54a, and the notification device 16A can be strongly attached. It is prevented from falling off and the waterproof function is enhanced. Further, after the notification device 16A is removed, the notification device 16A can be easily removed from the cover 18 and only the cover 18 can be discarded. That is, the notification device 16A is detachably attached to the detection device 12 by the cover 18 as a fixing tool.

As shown in FIG. 5, the control unit 42 of the transmitter unit 22 has a function of controlling the notification of the notification device 16A. Specifically, the control unit 42 constructs the glucose level measurement unit 56, the communication control unit 58, and the notification control unit 62 in accordance with the execution of the above-mentioned inspection program. Further, the information processing apparatus 14 constructs a notification processing unit 64, a communication control unit 66, and an abnormality determination unit 68 by executing and processing a processing program stored in the memory 14b by the processor 14a.

The glucose value measuring unit 56 controls the drive of the detection circuit unit 28 and the sensor unit 30, detects a signal related to the amount of glucose in the interstitial fluid at an appropriate timing, and obtains an appropriate measured value based on the detected signal. Convert. Further, the glucose value measuring unit 56 associates the measured value with the measurement date and time and stores it in the memory. The timing of measuring the glucose level is, for example, performed at predetermined intervals, the period varies according to the user's daily rhythm, the period is lengthened when there is free time from the meal, and the period is set before and after the user eats. It may be designed as appropriate, such as by shortening it.

When the measured value is obtained by the glucose value measuring unit 56, the communication control unit 58 of the transmitter unit 22 generates transmission data of the measured value to be transmitted to the outside (information processing device 14), and also controls the communication module 36. The measured value is output to the information processing device 14. Further, the communication control unit 58 has a communication determination unit 58a that detects a communication state with the information processing device 14 and determines whether or not a communication abnormality (information on the occurrence of an abnormality related to a medical device) has occurred.

The notification control unit 62 notifies the abnormality occurrence information detected by the abnormality determination unit 68 and the communication abnormality detected by the communication control unit 58 (communication determination unit 58a). Further, the notification control unit 62 constantly applies a weak bias power to the feeding unit 40, and monitors the attachment state of the notification device 16A to the detection device 12. When the power feeding unit 40 and the power receiving unit 48 face each other with the notification device 16A attached, the power or magnetic field flowing through the coil of the power feeding unit 40 changes. Therefore, the notification control unit 62 detects the change in the power or magnetic field and notifies the notification device. Judge the mounting state of 16A.

Further, when the notification device 16A is attached to the detection device 12, the notification control unit 62 transmits the installation information of the notification device 16A to the information processing device 14 via the communication control unit 58. Then, when the transmitter unit 22 receives information (glucose value abnormality information) indicating that the glucose value is abnormal from the information processing device 14, or the communication determination unit 58a determines the communication abnormality, the notification control unit 62 is not shown. The switch unit is switched to supply the power of the battery 38 to the power supply unit 40. As a result, a warning sound is output from the notification device 16A.

On the other hand, the notification processing unit 64 of the information processing device 14 displays the glucose value transmitted by the detection device 12 in an appropriate format. Further, the notification processing unit 64 notifies an alert corresponding to the glucose value abnormality when the abnormality determination unit 68 determines the glucose value abnormality based on the glucose value, or alerts according to the communication abnormality when the communication control unit 66 determines the communication abnormality. Is notified.

When the processor 14a receives the mounting information of the notification device 16A from the transmitter unit 22, for example, the processor 14a recognizes the mounting state by raising the mounting flag (not shown). As a result, the notification processing unit 64 stops the notification of the alert based on each abnormality while recognizing the mounting state.

The communication control unit 66 controls communication with the detection device 12, receives the glucose value, and stores it in the memory 14b. Further, when the abnormality determination unit 68 determines the glucose value abnormality in the mounted state (the state in which the mounting flag is 1) of the notification device 16A, the glucose value abnormality information is transmitted to the transmitter unit 22.

The abnormality determination unit 68 has, for example, a determination threshold value (not shown) and determines an abnormality (hyperglycemia / hypoglycemia) in the acquired glucose value. Then, when the glucose value abnormality is determined and the attachment flag is 0, the alert processing unit 64 is notified of the alert, and when the glucose value abnormality is determined and the attachment flag is 1, the glucose value abnormality information is executed. Is sent to the transmitter unit 22.

The medical device system 10A according to the present embodiment is basically configured as described above, and its action and effect will be described below.

The medical device system 10A is applied to continuously detect a user's glucose level, and is placed on a body surface such as a flank that does not interfere with the user's daily life by the user or a medical worker. At the time of this indwelling, the sensor unit 30 is inserted under the skin of the user by an insertion device (not shown). At the time of indwelling, the indwelling portion 24 integrated with the detection main body portion 20 and the sensor portion 30 is fixed on the body surface, and then the transmitter portion 22 is attached. Alternatively, the transmitter unit 22 may be attached in a series of indwelling operations.

The transmitter unit 22 forms a pairing (establishes communication) with a predetermined information processing device 14, so that data can be transmitted and received between the detection device 12 and the information processing device 14. Then, the control unit 42 operates the detection circuit unit 28 to detect the glucose value of the user, and transmits the information of the detected glucose value to the information processing apparatus 14. The information processing device 14 stores the glucose value information acquired from the detection device 12 in the memory 14b, and appropriately displays it on the display unit 14f.

Then, when the user performs sports, bathing, or the like, the detection device 12 and the notification device 16A are linked according to the method shown in FIG. 6A. Specifically, the user first attaches the fixed portion 46a of the notification device 16A to a predetermined position of the cover 18 (central portion 54a of the adhesive layer 54) to integrate the notification device 16A and the cover 18 (step S1: Cover application process, see also FIG. 4A). In this state, the user arranges the notification device-side housing 46 so as to overlap the upper portion of the transmitter-side housing 32, and further, the peripheral portion 54b of the cover 18 protruding from the periphery of the notification device 16A is placed on the user's body surface. Paste (step S2: notification device fixing step, also see FIG. 4B). Since the cover 18 extends radially outward from the indwelling portion 24 of the detection device 12, it is possible to attach the peripheral portion 54b having a strong adhesive force without touching the indwelling portion 24.

With the implementation of this notification device fixing step, the control unit 42 (notification control unit 62) of the detection device 12 detects a change in the current value or the magnetic field of the feeding unit 40 (step S3: notification device confirmation step). As a result, the notification control unit 62 of the transmitter unit 22 transmits the mounting information of the notification device 16A to the information processing device 14 (step S4: mounting information transmission step). Therefore, the information processing apparatus 14 is in the alert stop standby state in which the attachment flag is raised and the notification of the alert by the information processing apparatus 14 is stopped when the glucose value abnormality occurs. On the other hand, the information processing apparatus 14 is in a standby state in which glucose value abnormality information can be transmitted to the transmitter unit 22 (step S5: notification switching step).

Further, the measured value (measurement signal) measured by the detection device 12 continues to be transmitted to the information processing device 14, and the information processing device 14 (notification processing unit 64) processes the measured value transmitted from the detection device 12. And convert it to glucose value. The abnormality determination unit 68 determines whether or not the glucose value is abnormal by comparing the glucose value converted by the notification processing unit 64 with the determination threshold value held in the information processing apparatus 14 (step S6: glucose value abnormality). Monitoring process).

When the glucose value abnormality is determined, the communication control unit 66 transmits glucose value abnormality information to the notification control unit 62 of the detection device 12 via the communication module 14d based on the attachment flag. The notification control unit 62 switches the switch unit to supply the power of the battery 38 to the power supply unit 40. As a result, an alert is output from the notification device 16A (step S7: abnormality notification step). During this time, even if the information processing device 16A is attached, the information processing device 14 can continuously acquire glucose value information, display it on the information processing device 14, and store it in the memory 14b on the information processing device side. ..

Further, apart from each step described above, in the state after step S5, the communication control unit 58 (communication determination unit 58a) of the transmitter unit 22 communicates with the information processing device 14 according to the method shown in FIG. 6B. The occurrence of an abnormality such as an abnormality related to the device is monitored (step S11: communication abnormality monitoring step). Then, when the notification control unit 62 receives a determination from the communication control unit 58 that a communication abnormality has occurred, the notification control unit 62 supplies the power of the battery 38 to the power supply unit 40, and wirelessly from the power supply unit 40 to the power reception unit 48 (notification device 16A). Power is supplied. As a result, the notification device 16A can sound the notification member 52 to notify the user of the occurrence of an abnormality (step S12: abnormality notification step). In the case of a communication abnormality, when the communication module 14d of the information processing apparatus 14 detects a communication interruption, it is transmitted as abnormality information to the abnormality determination unit 68, and information on the occurrence of a communication abnormality or the occurrence of data loss is displayed as a buzzer sound. , It may be configured to be notified by light or the like.

As described above, the medical device system 10A according to the present embodiment has the following effects.

The medical device system 10A includes the detection device 12, the notification device 16A, and the cover 18, so that the notification device 16A can be fixed at a position near the detection device 12 as needed and the notification device 16A can perform notification. .. For example, even if the information processing device 14 is located away from the detection device 12, the notification device 16A notifies the user of an abnormality in glucose level, communication abnormality, or the like by notifying the user in the vicinity of the user when an abnormality occurs. It is possible to recognize it. That is, even in a situation where the user cannot confirm the alert by the information processing apparatus 14, the user can notice the alert. In particular, the medical device system 10A can easily fix the notification device 16A to the body surface and separate it from the detection device 12 (remove it from the body surface) by using the cover 18. Further, in the medical device system 10A, since the notification device 16A is not attached in the normal state, the detection device 12 can be made lighter and has a longer life, and the indwelling state can be maintained well and the living body can be attached to the external information processing device 14. It is possible to transmit signals such as information. This makes it possible to attach the notification device 16A in a detachable manner while achieving good wearability under normal usage conditions (the mounting state of the indwelling portion 24, the sensor-side housing 26, and the transmitter-side housing 32). Therefore, convenience is improved.

In the medical device system 10A, the notification device 16A is installed on the body surface without expanding the installation range on the body surface by stacking the notification device 16A on the upper part of the detection device 12 with the notification device 16A attached to the cover 18. Then, the detection device 12 and the notification device 16A can be more reliably linked (communication of information and supply of electric power).

Normally, the detection device 12 transmits the biometric information to the information processing device 14, so that the user can confirm the information processing device 14 and recognize the biometric information. Further, in a normal time, the user can recognize the abnormality via the information processing device 14. When the notification device 16A is arranged, even if the information processing device 14 is separated, the occurrence of an abnormality can be promptly notified to the user via the notification device 16A.

By monitoring the arrangement of the notification device 16A, the medical device system 10A can easily recognize that the notification device 16A is arranged at a position in the vicinity of the detection device 12. Then, the information processing device 14 stops issuing an alert based on the abnormal glucose value due to the arrangement of the notification device 16A, so that the information processing device 14 can be prevented from ringing at a distant position.

Since the notification device 16A can be notified by being supplied with electric power from the battery 38 of the detection device 12, the notification device 16A itself can be simplified and reduced in weight, and can be easily carried by the user.

In particular, since the detection device 12 and the notification device 16A have the wireless power feeding structure 44, the power of the battery 38 can be easily provided to the notification device 16A even if the detection device 12 and the notification device 16A do not have a connection line. can do. Therefore, the handling of the notification device 16A becomes easier.

By having the buzzer as the notification member 52, the notification device 16A can satisfactorily notify the user of the occurrence of an abnormality with a warning sound.

As described above, the information regarding the abnormality of the biometric information obtained from the user is particularly useful for the user. Examples of the information regarding the abnormality of the biological information include the case where the glucose level in the interstitial fluid is too high (hyperglycemia) and the case where the glucose level is too low (hypoglycemia). In particular, when the glucose level in the interstitial fluid is low, the user is in a hypoglycemic state, which is a dangerous state. However, by using the notification device 16A, the user can quickly and surely obtain biometric information. It is possible to notify the abnormality.

The abnormality determination unit 68 for determining an abnormality in the glucose value is provided in the information processing apparatus 14. In this case, the signal related to the biological information detected by the sensor unit 30 is transmitted to the information processing device 14 via the communication control unit 58. A signal (for example, a current value) related to biological information is processed by a calculation unit in the information processing apparatus 14 and converted into a measured value (for example, a glucose value). The abnormality determination unit 68 detects a case where the measured value deviates from a predetermined range as an abnormality in the biological information by comparing the measured value converted here with a preset threshold value. In response to the abnormality detection, the abnormality occurrence information is transmitted to the notification control unit 62 through the communication control unit 58 of the transmitter unit 22. The notification device 16A can issue an alarm by supplying electric power by the power feeding unit 40 based on the abnormality occurrence information. Further, at this time, the detection device 12 can detect that the notification device 16A is arranged based on the change in the current flowing through the coil on the power feeding unit 40 side. By configuring the information processing device 16 to transmit the information in which the notification device 16A is arranged in the detection device 12 to the information processing device 14 via the communication control unit 58, the alert issuance from the information processing device 14 is automatically stopped. Can be done. That is, the alarm issuance by the information processing apparatus 14 can be stopped as the alarm can be activated by the notification device 16A. As a result, even if the information processing device 14 is placed at a place away from the user, it is possible to prevent the information processing device 14 from continuously emitting an alert (sound, vibrator).

When the notification device 16A issues an alarm based on an abnormality in the biological information, even if the abnormality determination unit 68 determines that the biological information is abnormal, the transmitter unit 22 does not interrupt the wireless communication with the information processing device 14. Data transmission is sequentially performed between the information processing apparatus 14 and the information processing apparatus 14. With such a configuration, it is possible to prevent the loss of continuous measurement data while recording the abnormality of the biological information.

The present invention is not limited to the above-described embodiment, and various modifications can be made according to the gist of the invention. Next, some other embodiments of the present invention will be illustrated. In the following description, elements having the same configuration or the same function as those in the above-described embodiment are designated by the same reference numerals, and detailed description thereof will be omitted.

[Second Embodiment]
As shown in FIGS. 7A and 7B, the medical device system 10B according to the second embodiment is different from the medical device system 10A according to the first embodiment in that the notification device 16B performs notification by vibration by a vibrator. Specifically, the notification device 16B has an L-shaped notification device side housing 70 in a side sectional view, and inside the notification device 16B, a notification battery 71, an RFID reader / writer 72 (communication module), a vibrator motor 74, and a control. It has a substrate 76. That is, the notification device 16B can supply power to the internal electrical components by the notification battery 71 of the device itself, without supplying power from the battery 38 of the transmitter unit 22. As described above, if the notification battery 71 that supplies power only to the notification device 16B is further provided in the notification device 16B, it is possible to select a notification means (here, a vibrator) having a large power consumption.

The RFID reader / writer 72 performs wireless communication with the RFID tag 78 provided inside the detection device 12 (transmitter unit 22). The RFID tag 78 transmits the abnormality occurrence information to the RFID reader / writer 72 under the control of the control unit 42. Further, the RFID tag 78 is provided on the upper part of the transmitter unit 22 and is configured to be able to detect the electromagnetic wave of the RFID reader / writer 72. Therefore, the control unit 42 can confirm the attachment of the notification device 16B based on the monitoring of the electromagnetic wave of the RFID tag 78.

A known vibrator motor 74 can be applied to the vibrator motor 74 provided in the notification device 16B, and the entire notification device 16B is vibrated by rotating based on the power supply from the notification battery 71. The vibration of the vibrator motor 74 is transmitted to the body surface of the living body via the detection device 12.

An electronic control circuit 76a having a microcomputer (not shown) is formed on the control board 76. The control board 76 has an RFID reader / writer 72 on the surface facing the body surface, and a notification battery 71 on the opposite surface. Further, the electronic control circuit 76a is connected to the vibrator motor 74, and the microcomputer of the electronic control circuit 76a can switch the supply or stop of the power supply of the notification battery 71.

The medical device system 10B according to the second embodiment is basically configured as described above. Similar to the first embodiment, the medical device system 10B is positioned together with the cover 18 by the user after the notification device 16B is attached to a predetermined position of the cover 18 and then positioned on the upper portion and the side portion of the detection device 12. It is pasted on the body surface. In this state, the RFID reader / writer 72 of the notification device 16B can read the information from the RFID tag 78 of the detection device 12. Then, in the control board 76 of the notification device 16B, the control unit 42 of the detection device 12 rotationally drives the vibrator motor 74 by transmitting the abnormality occurrence information from the RFID tag 78.

Therefore, even with this medical device system 10B, the same effect as that of the medical device system 10A according to the first embodiment can be obtained. In particular, by having the vibrator motor 74, the notification device 16B can satisfactorily notify the user of the occurrence of an abnormality by vibration, and can suppress the sound from being heard by the surrounding people.

[Third Embodiment]
As shown in FIGS. 8A and 8B, the medical device system 10C according to the third embodiment is a medical device system according to the first and second embodiments in that the notification device 16C has a monitor 80 for displaying an abnormality or the like. It is different from 10A and 10B. Specifically, the notification device 16C is connected to the monitor 80, the control board 82 on which the monitor 80 is mounted and controls the display of the monitor 80, and the control board 82, and extends from the notification device side housing 84. It has a connecting line 86 to be output. As the monitor 80, a known one such as a liquid crystal display or an organic EL can be applied. Further, the housing 84 on the notification device side is formed larger than the detection device 12 in a plan view, and the size of the monitor 80 is increased.

An electronic control circuit 82a having a microcomputer (not shown) is formed on the control board 82. The control board 82 can display the information transmitted from the transmitter unit 22, for example, receives the information on the glucose value detected by the detection device 12 and displays the glucose value on the monitor 80. Further, when the abnormality occurrence information is received from the detection device 12, the monitor 80 displays the occurrence of the abnormality with a message, an icon or the like. At least a part of the portion where the cover 18 and the monitor 80 are in contact with each other, or the entire cover 18 is transparent. As a result, the user can check the display contents of the monitor 80 from above the cover 18.

The connection line 86 includes a notification device side connector 86a at its free end, and the notification device side connector 86a is connected to a wired connection connector 88 provided in the detection device 12. That is, the electric power of the notification device 16C is supplied from the battery 38 of the transmitter unit 22 via the wired connection connector 88 and the connection line 86. Therefore, the notification device 16C does not need to be provided with the battery 38, and the weight can be reduced. Further, information on the glucose value of the detection device 12 and information on the occurrence of an abnormality are also transmitted to the control board 82 via the wired connection connector 88 and the connection line 86. Therefore, the notification device 16C can obtain information more reliably.

As described above, the medical device system 10C according to the third embodiment can also obtain the same effects as the medical device systems 10A and 10B according to the first and second embodiments. In particular, since the notification device 16C has the monitor 80, the notification device 16C can satisfactorily notify the user of the occurrence of an abnormality by the monitor display, and also notifies a wider variety of information such as the glucose value measured by the detection device 12. It becomes possible to do.

[Fourth Embodiment]
In the medical device system 10D according to the fourth embodiment, as shown in FIG. 9A, the detection device 12 is covered with a cover 90, and a notification device 16A having a waterproof function can be attached to the upper portion of the cover 90. For example, the cover 90 has an adhesive layer 54 on the entire surface of the body surface to be opposed to the body surface, and has an adhesive layer 92 on a part (central portion) of the opposite surface thereof, so that the notification device 16A can be attached. Therefore, in the notification device 16A, the lower surface of the notification device side housing 46 is the fixed portion 46a. Even if the notification device 16A is attached to the outside of the cover 90 in this way, the operation of the notification device 16A can be performed by wireless communication or wireless power supply, and the abnormality of the detection device 12 can be satisfactorily notified. ..

[Fifth Embodiment]
In the medical device system 10E according to the fifth embodiment, as shown in FIG. 9B, the cover 94 has a hard cover 94a that covers the notification device 16A and a soft cover 94b that is fixed around the hard cover 94a and is more flexible than the hard cover 94a. And have. The hard cover 94a corresponds to a container that is not flexible and is not coated with the adhesive layer 54, and can accommodate the notification device 16A. The soft cover 94b has an adhesive layer 54 on a surface to be opposed to the body surface, and a part of the inside is attached to the flange of the hard cover 94a and another part of the outside is attached to the body surface. As a result, the notification device 16A and the cover 94 are not attached to each other, so that the notification device 16A can be easily removed from the cover 94, and the notification device 16A can be reused better.

It goes without saying that the medical device systems 10A to 10E according to each of the above-described embodiments may be applied to other embodiments by taking out a part of the configurations. For example, the notification devices 16A to 16C can include not only one type of configuration of the buzzer, the vibrator motor 74, and the monitor 80, but also a plurality of types of configurations as the notification member 52. Further, the medical devices handled by the medical device systems 10A to 10E are not limited to the detection device 12 that detects biological information (glucose value).

Further, in the medical device systems 10A to 10E according to each embodiment, the abnormality determination unit 68 detects that the abnormal state related to the medical device or biometric information has been resolved and the normal state has been restored, so that the notification devices 16A to 16A to The notification by 16C may be stopped. It is also possible to temporarily stop the notification by tapping (tapping) the notification devices 16A to 16C with the user's fingertip two or three times.

10A to 10E ... Medical device system 12 ... Detection device 14 ... Information processing device 16A to 16C ... Notification device 18 ... Cover 20 ... Detection main unit 22 ... Transmitter unit 40 ... Power supply unit 42 ... Control unit 44 ... Wireless power supply structure 48 ... Power receiving Part 52 ... Notification member 74 ... Vibrator motor 80 ... Monitor

Claims (9)

Medical devices placed on the body surface of living organisms and
A notification device that performs notification based on a signal or electric power output from the medical device, and
Fixtures for fixing the notification device to the medical device,
An information processing device for wirelessly communicating biometric information with the medical device is provided.
The notification device is detachably attached to the medical device by the fixture and is attached to the medical device.
The medical device has a detection unit for detecting the biological information of the living body and a control unit for acquiring the occurrence of the biological information or an abnormality related to the medical device.
The control unit monitors the arrangement of the notification device in the vicinity of the medical device, and transmits information indicating that the notification device has been arranged to the information processing device in accordance with the arrangement of the notification device. A medical device system characterized in that notification of the notification device is performed based on information on the occurrence of the abnormality in a state where the notification device is arranged at a position in the vicinity of the medical device. In the medical device system according to claim 1,
The notification device is a medical device system characterized in that the notification device is attached to a cover as the fixing tool and is fixed to the body surface by being attached to the medical device. In the medical device system according to claim 1 ,
The information processing device notifies the occurrence information of the abnormality in the non-attached state of the notification device, while monitoring the arrangement of the notification device in the vicinity of the medical device, and in the attached state of the notification device. A medical device system characterized in that the notification of the occurrence information of the abnormality is stopped. In the medical device system according to any one of claims 1 to 3 .
The medical device has a battery that supplies power to internal electrical components.
The notification device is a medical device system characterized in that electric power is supplied from the battery in a state of being placed on the body surface to enable notification. In the medical device system according to claim 4 ,
The medical device and the notification device are a medical device system having a wireless power supply structure that wirelessly supplies power to the notification device from the battery. In the medical device system according to any one of claims 1 to 5 .
The notification device is a medical device system characterized by having a buzzer for notifying biological information or information on the occurrence of an abnormality related to the medical device with a warning sound. In the medical device system according to any one of claims 1 to 5 .
The notification device is a medical device system characterized by having a vibrator that vibrates to notify biological information or information on the occurrence of an abnormality related to the medical device. In the medical device system according to any one of claims 1 to 5 .
The notification device is a medical device system including a monitor that displays biological information or information on the occurrence of an abnormality related to the medical device. In the medical device system according to claim 2,
The cover has an adhesive layer and
The adhesive layer is
The first part to which the notification device is attached and
Including the second part attached to the body surface,
A medical device system characterized in that the adhesive strength of the second portion is stronger than the adhesive strength of the first portion.

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