The present invention relates, for example, to a biosensor for measuring the concentration of glucose, amino acid, or the like in a living body, and a device for inserting this biosensor under the skin of a patient.
A conventional wearable sensor device is configured to comprise a sensor that is inserted into a human body, a mount unit to which this sensor is mounted and which is mounted on the skin of the human body, and an electronic unit that is mounted to this mount unit, is electrically connected to the sensor, and has a control unit that calculates biometric information from signals inputted from the sensor.
The user attaches the mount unit to the skin, uses the sensor insertion device to insert the sensor into the human body through an opening in the mount unit, and then attaches the electronic unit to the mount unit, thereby electrically connecting the electronic unit and the sensor (see Patent Literature 1, for example).
Also, as an example of a sensor insertion device that inserts a sensor into a human body, a configuration of a puncture mechanism has been disclosed in which a needle is inserted into a human body in a state in which the sensor is enclosed in the needle, and then just the needle is pulled out by spring force (see Patent Literature 2, for example).
Also, there is a configuration in which a puncture mechanism for inserting and withdrawing a needle is constituted by a link mechanism that is linked to a trigger button (see Patent Literature 3, for example).
Also, a configuration has been disclosed in which a coil spring is used for a mechanism for inserting and withdrawing a needle (Patent Literature 4).
Patent Literature 1: U.S. Pat. No. 8,801,611
Patent Literature 2: U.S. Pat. No. 9,402,544
Patent Literature 3: U.S. Patent Application Publication No. 2013/0267811
Patent Literature 4: WO 2017/187943
A problem with the above-mentioned conventional wearable sensor device was that it was difficult to be attached to the human body.
That is, with a conventional wearable sensor device, the user inserted the sensor into the body, and then attached the electronic unit to the mount unit, thereby electrically connecting the electronic unit and the sensor. If the sensor was attached at a location that could not be seen (such as on the outside of the upper arm), it was difficult to visually check the mount unit and the sensor, so the electronic unit had to be attached to the mount unit and the sensor by feel.
Also, even when the electronic unit was attached in a visible location, the relatively small electronic unit had to be held in the fingers and attached to the mount unit and the sensor, so it was difficult to mount the wearable sensor device on the body.
In view of this, it is an object of the present invention to facilitate the mounting of a wearable sensor device on a human body.
To achieve this object, the wearable sensor device of the present invention comprises a sensor at least part of which is inserted into a human body, and which has a first connection terminal; a mount unit on which at least part of the first connection terminal of the sensor is to disposed and which is mounted on the skin of a human body; an electronic unit that has a second connection terminal connected to the first connection terminal of the sensor, and a control unit for acquiring signals from the sensor; and a mounting mechanism that links the electronic unit to the mount unit in a rotatable state and mounts the electronic unit to the mount unit. The mounting mechanism forms a first state where the mount unit and the electronic unit are mounted in a state where the first connection terminal and the second connection terminal have yet to be connected, and a second state where the mount unit and the electronic unit are mounted in a state where the first connection terminal and the second connection terminal have been connected.
With to the configuration of the present invention, after the sensor has been inserted into the human body, the electronic unit goes from the first state to the second state and is mounted to the mount unit via the mounting mechanism, which allows the wearable sensor device to be easily attached to the body.
As an example of a continuous glucose monitoring (CGM) system according to an embodiment of the present invention, a case of application to a glucose sensor for measuring glucose will now be described with reference to the appended drawings.
A continuous glucose monitoring (CGM) system continuously measures blood glucose levels in diabetic patients.
In the following description, “lower” means the puncture side (the side from which the needle protrudes) in the puncture direction in which the patient is punctured, and “upper” means the opposite side from the puncture side (the puncture knob side).
With the wearable sensor device 1 of the continuous glucose monitoring (CGM) system, a sensor 5 (see
The wearable sensor device 1 in this embodiment converts the glucose concentration into a current value, and transmits this calculated value. With the wearable sensor device 1, for example, the current value is measured once every minute, the arithmetic mean for a specific number of measurements is found, and that value is recorded in a memory. Then, the wearable sensor device 1 stores the five-minute value of the glucose concentration by storing the value of the arithmetic mean of the values for five samples acquired once every minute in the memory, for example.
As shown in
The wearable sensor device 1 stores in a memory the current value received by the electronic unit 3 from the sensor 5, or a glucose concentration value calculated on the basis of that current value, and wirelessly transmits the value stored in the memory to the measurement device 4. The value that is transmitted may be a current value, or may be a value converted into glucose concentration. The measurement device 4 calculates the glucose concentration from the value read by the sensor 5, displays the calculation result along with time information, and stores the time information and the glucose concentration in the memory inside the measurement device 4.
Continuously carrying out this glucose level measurement for about 3 to 14 days makes it possible to ascertain any fluctuation in the glucose level of a diabetic patient over the course of 24 hours. This means it is possible to perform a more appropriate treatment according to the symptoms of each diabetic patient on the basis of the fluctuation in blood glucose level.
Furthermore, the amount and timing of insulin administration to the patient can be calculated using this blood glucose level fluctuation information. An insulin pump administers the proper amount of insulin while monitoring the blood glucose level of the patient in real time while being connected wirelessly to the wearable sensor device 1 (and/or the measurement device 4). The system therefore functions as an artificial pancreas, so blood glucose can be kept at the ideal level.
With the wearable sensor device 1, the sensor 5 protrudes from the lower surface side that is in contact with the upper arm 2. The sensor 5 is placed under the skin when the wearable sensor device 1 is attached to the body.
The distal end portion of the sensor 5 is needle-shaped or rod-shaped to make it easier to insert this portion under the skin of a diabetic patient, and is about 1 cm in length. The distal end portion of the sensor 5 is covered with a protective film through which glucose (the test substance) permeates and is absorbed and which causes the glucose to react with an enzyme to produce a measurement substance, and a reaction layer that is constituted by an enzyme layer, a mediator layer, or the like.
An electrode for electrochemically measuring glucose is provided under the reaction layer. The glucose concentration in the interstitial fluid of the subcutaneous tissue can be observed (and/or measured/sensed) by leaving the electrode in the interstitial fluid in a state in which this distal end portion has been inserted under the skin.
With a subcutaneous indwelling glucose sensor such as this that measures glucose in subcutaneous tissue, there may be a time lag between the blood glucose level and the measurement result. This means that correction may be necessary using a measurement value from a glucose sensor for the self-monitoring of blood glucose (SMBG).
When the wearable sensor device 1 is mounted on the body, the mount unit 6 is disposed on the skin. The sensor 5 is attached to the mount unit 6 via a connection terminal. The electronic unit 3 is then mounted on the mount unit 6. The electronic unit 3 and the sensor 5 are connected via the mount unit 6.
The configuration of the wearable sensor device 1 according to an embodiment of the present invention will now be described.
As shown in
At least a part of the sensor 5 is inserted into the patient's body, and the sensor 5 has a sensor connection terminal (first connection terminal) 7.
The mount unit 6 has at least a part of the sensor connection terminal 7 of the sensor 5 disposed thereon, and is mounted on the skin of the patient's body.
The electronic unit 3 has a second connection terminal 10 that is connected to the sensor connection terminal 7 of the sensor 5, and a control unit 20 (see
The hinge mechanism 8 allows the electronic unit 3 to rotate with respect to the mount unit 6 to switch between a contact state in which the electronic unit 3 is disposed opposite the mount unit 6 such that the surfaces thereof are close to each other, and a non-contact state. The hinge mechanism 8 forms a first state where the mount unit 6 and the electronic unit 3 are mounted in a state in which the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state where the mount unit 6 and the electronic unit 3 are mounted in a state in which the sensor connection terminal 7 and the second connection terminal 10 have been connected.
The hinge mechanism 8 is provided so as to link the ends of the electronic unit 3 and the mount unit 6 as shown in
In a state in which the components have been disconnected by the hinge mechanism 8, the hinge mechanism 8 is separated into a hinge member 8a on the electronic unit 3 side and a hinge member 8b on the mount unit side. The hinge mechanism 8 is configured so that when a projection of the hinge member 8a is fitted into the an opening in the hinge member 8b, the electronic unit 3 is rotated with respect to the mount unit 6.
When both ends of the projection of the hinge member 8a are pivotally supported by the insertion opening in the hinge member 8b, the hinge member 8a rotates with respect to the hinge member 8b, with the projection serving as the axis of rotation. This results in the attachment of the electronic unit 3 to the mount unit 6 in an openable and closable state.
An insertion opening 9 into which a part of the sensor connection terminal 7 is fitted is provided on the bottom surface side of the electronic unit 3. The insertion opening 9 is provided with the second connection terminal 10 that connects to the sensor connection terminal 7.
An O-ring 11 is provided as a waterproof member around the periphery of the insertion opening 9. The O-ring 11 is disposed so as to be sandwiched between the electronic unit 3 and the mount unit 6 when the electronic unit 3 and the mount unit 6 are linked facing each other. As a result, the O-ring 11 functions as a waterproofing mechanism that prevents the intrusion of water or the like into the sensor connection terminal 7 and the second connection terminal 10.
The wearable sensor device 1 further comprises locking mechanisms 12 and 13 that fix the electronic unit 3 and the mount unit 6 in order to keep the electronic unit 3 and the mount unit 6 in a linked state (the second state). The locking mechanisms 12 and 13 have snap fits 12a and 12b provided on the mount unit 6 side, and insertion openings 13a and 13b provided on the electronic unit 3 side. In a state in which the electronic unit 3 and the mount unit 6 are linked to each other, the snap fit 12a and the insertion opening 13a, and the snap fit 12b and the insertion opening 13b are mated to each other. As a result, the linked state of the electronic unit 3 and the mount unit 6 is maintained.
The bottom surface of the mount unit 6 serves as an adhesive surface that is attached to the skin of the upper arm 2 or the like. An adhesive material such as a skin tape is provided on the bottom surface of the mount unit 6 to facilitate adhesion to the skin. When coupling the locking mechanisms 12 and 13, it is necessary to apply a downward force from above. Consequently, when a downward force is applied in coupling the locking mechanisms 12 and 13, this causes the bottom surface of the mount unit 6 to be pressed against the skin. As a result, the wearable sensor device 1 is more securely attached to the skin of the upper arm 2.
The electronic unit 3 and the mount unit 6 are linked in a rotatable state via the hinge mechanism 8.
When the second connection terminal 10 of the electronic unit 3 and the sensor connection terminal 7 of the mount unit 6 have been connected, the two components are linked by rotating the electronic unit 3 around the protruding portion of the hinge member 8a of the hinge mechanism 8.
Here, the angle formed by the mount unit 6 and the electronic unit 3 around the protrusion of the hinge member 8a of the hinge mechanism 8 is defined as the rotation angle.
In this way, the electronic unit 3 and the mount unit 6 are linked together by the hinge mechanism 8. The hinge mechanism 8 forms the first state where the mount unit 6 and the electronic unit 3 are mounted to each other in a state in which the sensor connection terminal 7 linked to the sensor 5 and the second connection terminal 10 provided on the electronic unit 3 side have yet to be connected.
The first state is a state in which the sensor connection terminal 7 and the second connection terminal 10 are not yet connected to each other, as shown in
Furthermore, the hinge mechanism 8 forms the second state where the mount unit 6 and the electronic unit 3 are mounted in a state in which the sensor connection terminal 7 connected to the sensor 5 and the second connection terminal 10 provided on the electronic unit 3 side connected.
In the second state, as shown in
Thus, in this embodiment, the hinge mechanism 8 can form the first state where the mount unit 6 and the electronic unit 3 are attached to each other in a state in which the sensor connection terminal 7 and the second connection terminal 10 are not yet connected, and a second state where the mount unit 6 and the electronic unit 3 are attached to each other in a state in which the sensor connection terminal 7 and the second connection terminal 10 are connected, which allows the wearable sensor device 1 to be easily attached to the patient.
That is, after the sensor 5 has been inserted into the body, the electronic unit 3 is rotated with respect to the mount unit 6 via the hinge mechanism 8, and this simple operation switches from the first state to the second state, and attaches the electronic unit 3 to the mount unit 6, making it easy to attach the wearable sensor device 1 to the patient's body.
Consequently, even if the place where the sensor is to be attached cannot be seen (such as the outside of the upper arm part 2), the electronic unit 3 can be attached to the mount unit 6, and the sensor connection terminal 7 and the second connection terminal 10 can be connected, by the simple operation of rotating the electronic unit 3 via the hinge mechanism 8. As a result, the wearable sensor device 1 is easy to attach to the patient's body.
Since the mount unit 6 and the electronic unit 3 are rotatably linked together via the hinge mechanism 8, there is no need to grasp the relatively small electronic unit 3 to attach it to the mount unit 6 and the sensor 5. As a result, it is easy to attach the wearable sensor device 1 to the body.
Furthermore, the hinge mechanism 8 is provided with a spring or other such elastic body (not shown). An elastic body such as a spring biases the electronic unit 3 toward the mount unit 6.
Consequently, as shown in
As a result, the user can attach the electronic unit 3 to the mount unit 6 simply by lightly pressing on the electronic unit 3 from above with a finger, as shown in
Also, since the electronic unit 3 covers the sensor connection terminal 7 disposed on the mount unit 6 as shown in
The elastic body may be a torsion spring provided to the hinge mechanism, or may be a leaf spring.
Furthermore, a through-hole 14 through which passes a needle for puncturing the skin and inserting the sensor 5 into the body is provided above the sensor 5 of the mount unit 6.
In this embodiment, the electronic unit 3 is detachably attached to the mount unit 6 via the hinge mechanism 8 serving as a mounting mechanism.
Consequently, the electronic unit 3 can be attached to the mount unit 6 after the mount unit 6 and the sensor 5 attached to the mount unit 6 have been sterilized, so sterilization can be carried out in a state in which the electronic unit 3 has been separated.
Here, the reason for performing the sterilization with the electronic unit 3 separated is that the electronic unit 3 cannot be sterilized when electron beam sterilization is employed, for example, and therefore the electronic unit 3 must be separated from the member to be sterilized. Accordingly, because the electronic unit 3 is detachably mounted on the mount unit 6 via the hinge mechanism 8 serving as a mounting mechanism, sterilization can be performed with the electronic unit 3 in a separated state.
The sensor unit 18 in
With the electronic unit 3, the current value sensed by the sensor unit 18 and measured by a measurement unit 19 is transmitted to a control unit 20. In the control unit 20, the temperature near the sensor unit 18 is measured by a temperature sensor 21, the temperature is corrected, and the glucose concentration is calculated from the current value.
The control unit 20 repeatedly executes this calculation of the glucose concentration at predetermined sampling intervals. In this embodiment, this sampling interval is set to 1 minute, for example.
The control unit 20 then calculates an integrated average for the calculated glucose concentration at each predetermined recording interval, and records this result to the storage unit 22. In this embodiment, this recording interval is set to 5 minutes, for example. Consequently, the integrated average for 5 samples measured every 1 minute for 5 minutes is calculated, and the integrated average is recorded in the storage unit 22.
The control unit 20 transmits the value stored in the storage unit 22 to the measurement device 4 via the communication unit 23 according to an instruction from the measurement device 4.
The electronic unit 3 in this embodiment has a built-in battery 24 that supplies power to the measurement unit 19, the control unit 20, the temperature sensor 21, the communication unit 23, and so on. Usually, the electronic unit 3 is discarded at the point when the remaining battery level of the battery 24 becomes insufficient. The remaining battery level of the battery 24 is monitored through the measurement device 4.
When the sensor unit 18 is replaced, the measurement device 4 confirms whether or not the remaining charge of the battery 24 is sufficient to last until the next replacement of the sensor unit 18, with respect to the remaining charge of the battery 24 of the electronic unit 3. If the remaining charge is too low, the control unit 20 outputs an instruction message or audio telling the user to replace the electronic unit 3, and performs control so that the electronic unit 3 cannot be used.
In addition, in the configuration of the wearable sensor device 1 according to Embodiment 3 above, the electronic unit 3 is removably attached to the electronic unit housing 17. With this configuration, the battery (battery) 24 is located in a battery disposition unit provided to the electronic unit housing 17, rather than in the electronic unit 3, and supplies electric power to the electronic unit 3.
Consequently, the battery 24 does not have to be installed in the electronic unit 3, so the electronic unit 3 can be more compact.
Furthermore, when the sensor unit 18 is to be replaced, the electronic unit 3 is removed from the electronic unit housing 17, and the sensor unit 18, the mount unit 6, and the electronic unit housing 17 are discarded along with the battery 24. A new sensor unit 18, mount unit 6, electronic unit housing 17, and battery 24 are then installed, and the electronic unit housing 17 is attached.
This means that the electronic unit 3 can be used for an extended period of time, without its replacement depending on the remaining charge of the battery 24, so the cost of the product can be reduced.
The battery 24 may be disposed in the mount unit 6. In this case, since there is no need to install the battery 24 in the electronic unit 3, the electronic unit 3 can be more compact. Furthermore, when the sensor unit 18 is to be replaced, the electronic unit 3 is removed from the mount unit 6, and the sensor unit 18 and the mount unit 6 are discarded along with the battery 24. Installing a new sensor unit 18, mount unit 6, and battery 24 allows the electronic unit 3 to be used for an extended period of time, without its replacement depending on the remaining charge of the battery 24, so the cost of the product can be reduced.
In
In this state, the sensor 5 of the wearable sensor device 1 has punctured the skin of the patient.
The electronic unit 3 is linked to the mount unit 6 via the hinge mechanism 8 or 58 as described above. In a state in which the sensor insertion device 25 has released the wearable sensor device 1, the electronic unit 3 rotates and moves toward the mount unit 6 under its own weight. Alternatively, if there is a spring unit 16, such as with the hinge mechanism 58, the spring force of this spring unit 16 causes the electronic unit 3 to be substantially in contact with the mount unit 6 (closed).
In
An adhesive material is provided on the bottom surface of the mount unit 6. As described above, when the user pushes the upper surface of the electronic unit 3 downward with the finger 27, the mount unit 6 is pressed against the surface of the skin of the upper arm 2. Therefore, the adhesive material on the bottom surface of the mount unit 6 is more securely bonded to the skin of the upper arm 2.
As shown in
The internal configuration of the sensor insertion device 25 in this embodiment will now be described.
As shown in
The sensor insertion mechanism 29 has a puncture needle 32, a puncture needle holder 33, and a drive unit 34 that drives the puncture needle holder 33 downward in the puncturing direction, and pulls up the puncture needle holder 33 after the puncture to withdraw the puncture needle 32 from the skin.
In the configuration of the sensor insertion mechanism 29, the springs described in the above-mentioned Patent Literature 2 and 4, for example, may be used as the drive unit 34. Also, the link mechanism described in Patent Literature 3 may be used as the drive unit 34. In this embodiment, the specific configuration of the drive unit 34 will not be described in order to keep the description from becoming too complicated.
The support unit 30 is provided as a wall surface formed so as to extend downward from the ceiling surface in the upper case 26, and in the state shown in
Let us return to the description of
Inside the upper case 26, the mount unit 6 of the wearable sensor device 1 is held by the holding unit 31 in the lower part of the upper case 26.
The puncture needle 32 is in a state in which the sensor 5 is included therein.
The electronic unit 3 connected by the hinge mechanism 58 to the mount unit 6 is supported by the support unit 30. The electronic unit 3 is linked in a rotatable state to the mount unit 6 by the hinge mechanism 58. Therefore, the support unit 30 only needs to support the electronic unit 3 so as not to rotate.
Consequently, it is possible to form a first state in which the mount unit 6 and the electronic unit 3 of the wearable sensor device 1 are mounted in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state in which the mount unit 6 and the electronic unit 3 are mounted in a state where the connection terminal 7 and the second connection terminal 10 are connected. As a result, the wearable sensor device 1 can be easily attached to the patient's body.
That is, with the configuration of this embodiment, after the sensor 5 is inserted into the body, the support of the electronic unit 3 by the support unit 30 is released, and the electronic unit 3 goes from the first state to the second state, so that the electronic unit 3 is mounted on the mount unit 6. As a result, the wearable sensor device 1 can be easily attached to the patient's body.
The wearable sensor device 1 of this embodiment comprises the sensor 5, at least part of which is inserted into the patient's body, and which has the sensor connection terminal (first connection terminal) 7. At least part of the sensor connection terminal 7 of the sensor 5 is disposed on the mount unit 6 that is mounted on the skin of the patient. The electronic unit 3 has a second connection terminal 10 that is attached to the mount unit 6 via the hinge mechanism 8 of the attachment mechanism and is connected to the sensor connection terminal 7 of the sensor 5, and a control unit 20 (see
The hinge mechanism 8 forms a first state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the connection terminal 10 are connected.
A sensor insertion method for inserting the sensor 5 into the body using this wearable sensor device 1 will now be described.
First, a step of placing the mount unit 6 on the skin (S1) is performed in the first state in which the sensor connection terminal 7 of the mount unit 6 and the second connection terminal 10 of the electronic unit 3 have yet to be connected, that is, in a state in which the electronic unit 3 is supported by the support unit 30.
Next, a step of inserting the sensor 5 mounted on the mount unit 6 into the patient's body is performed (S2).
After the sensor 5 has been inserted into the body, a step of creating a second state in which the sensor connection terminal 7 of the mount unit 6 and the second connection terminal 10 of the electronic unit 3 are connected is performed (S3).
This forms a first state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 are connected. As a result, the wearable sensor device 1 can be easily attached to the body.
The configuration of the wearable sensor device 1 according to another embodiment of the present invention will now be described.
This embodiment differs from Embodiment 1 given above in that the configuration of the hinge mechanism 58 serving as a mounting mechanism that links the electronic unit 3 and the mount unit 6 together is different from the configuration of the hinge mechanism 8 discussed above. The rest of the configuration is the same as that in Embodiment 1, and those components will be numbered the same and will not be described in detail.
The wearable sensor device 1 comprises the electronic unit 3, the sensor 5, the mount unit 6, and the hinge mechanism 58.
At least part of the sensor 5 is inserted into the patient's body, and the sensor 5 has a sensor connection terminal (first connection terminal) 7.
The mount unit 6 has at least a part of the sensor connection terminal 7 of the sensor 5 disposed thereon, and is attached to the skin of the patient's body.
The electronic unit 3 has a second connection terminal 10 that is attached to the mount unit 6 via the hinge mechanism 58 (serving as an attachment mechanism) and is connected to the sensor connection terminal 7, and a control unit 20 (see
The hinge mechanism 58 (mounting mechanism) forms a first state in which the mount unit 6 and the electronic unit 3 are mounted to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have are connected.
As shown in
As shown in
As shown in
Here, the hinge portion 15 is formed at an angle at which the electronic unit 3 will be closed with respect to the mount unit 6.
Consequently, the thin-walled spring unit 16 of the hinge portion 15 exerts a biasing force that biases the electronic unit 3 in the closing direction when the electronic unit 3 has been opened with respect to the mount unit 6.
The bottom surface of the electronic unit 3 is provided with an insertion opening 9 into which part of the sensor connection terminal 7 fits. The second connection terminal 10 that is connected to the sensor connection terminal 7 is provided to the insertion opening 9.
An O-ring 11 is provided as a waterproof member around the periphery of the insertion opening 9. The O-ring 11 is disposed so as to be sandwiched between the electronic unit 3 and the mount unit 6 when the electronic unit 3 and the mount unit 6 are linked together. As a result, the O-ring 11 functions as a waterproofing mechanism that prevents water and the like from infiltrating the sensor connection terminal 7 and the second connection terminal 10.
The wearable sensor device 1 further comprises locking mechanisms 12 and 13 for maintaining a state in which the electronic unit 3 and the mount unit 6 are linked. The locking mechanisms 12 and 13 have snap fits 12a and 12b provided on the mount unit 6 side, and insertion openings 13a and 13b provided on the electronic unit 3 side. In a state in which the electronic unit 3 and the mount unit 6 are linked together, the snap fit 12a and the insertion opening 13a, and the snap fit 12b and the insertion opening 13b are fitted together. As a result, the linked state of the electronic unit 3 and the mount unit 6 is maintained.
The bottom surface of the mount unit 6 serves as an adhesive surface that is attached to the skin of the upper arm 2 or the like. An adhesive material such as skin tape is provided on the bottom surface of the mount unit 6 to facilitate bonding to the skin. In linking the locking mechanisms 12 and 13, it is necessary to apply a downward force from above. Therefore, when a downward force is exerted in the linking of the locking mechanisms 12 and 13, the bottom surface of the mount unit 6 is pressed against the skin where the device is to be attached. As a result, the wearable sensor device 1 is more securely attached to the skin of the upper arm 2.
The electronic unit 3 and the mount unit 6 are rotatably connected by the hinge mechanism 58.
When the electronic unit 3 and the mount unit 6 are linked together, the electronic unit 3 is coupled so as to rotate with the hinge mechanism 58 as its fulcrum.
Here, the angle formed by the mount unit 6 and the electronic unit 3 around the hinge mechanism 58 is defined as the rotation angle.
Thus, the electronic unit 3 and the mount unit 6 are linked to each other by the hinge mechanism 58. The hinge mechanism 58 forms the first state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 connected to the sensor 5 and the second connection terminal 10 provided on the electronic unit 3 side have yet to be connected.
The first state is a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected to each other, as shown in
Furthermore, the hinge mechanism 58 forms a second state in which the mount unit 6 and the electronic unit 3 are attached in a state where the sensor connection terminal 7 connected to the sensor 5 and the second connection terminal 10 provided on the electronic unit 3 side are connected.
This second state, as shown in
Thus, in this embodiment, because the hinge mechanism 58 forms the first state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and the second state in which the mount unit 6 and the electronic unit 3 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 are connected to each other, the wearable sensor device 1 can be easily attached to the body.
That is, after the sensor 5 has been inserted into the body, the electronic unit 3 is rotated with respect to the mount unit 6 via the hinge mechanism 58, and this simple operation causes a transition from the first state to the second state and mounts the electronic unit 3 on the mount unit 6, so the wearable sensor device 1 can be easily attached to the body.
Consequently, even if the sensor is attached at a location there cannot be seen (such as on the outside of the upper arm 2), the electronic unit 3 can be mounted on the mount unit 6, and the sensor connection terminal 7 and the second connection terminal 10 can be connected, by the simple operation of rotating the electronic unit 3 via the hinge mechanism 58. As a result, the wearable sensor device 1 can be easily attached to the body.
Also, since the mount unit 6 and the electronic unit 3 are rotatably linked via the hinge mechanism 58, there is no need to grasp the relatively small electronic unit to attach it to the mount unit 6 and the sensor 5. As a result, the wearable sensor device 1 can be easily attached to the body.
Furthermore, the hinge mechanism 58 is provided with an elastic body as described above. This elastic body is configured to bias the electronic unit 3 in the direction of mounting on the mount unit 6.
In this embodiment, the elastic body is constituted by the spring unit 16 provided to the hinge mechanism 58. The spring unit 16 is formed integrally with the hinge portion 15 using a resin or other such material. Therefore, the hinge mechanism 58 having an elastic body can be formed without increasing the number of parts.
Consequently, as shown in
As a result, the user can mount the electronic unit 3 to the mount unit 6 as shown in
Also, since the electronic unit 3 covers the sensor connection terminal 7 disposed on the mount unit 6 as shown in
The elastic body may be a torsion spring or a leaf spring linked to the hinge mechanism.
Furthermore, a through-hole 14 through which passes a needle for puncturing the skin and inserting the sensor 5 into the body is provided above the sensor 5 of the mount unit 6.
The configuration of the wearable sensor device 1 according to yet another embodiment of the present invention will be now described.
The wearable sensor device 1 of this embodiment differs from Embodiments 1 and 2 above in that it comprises an electronic unit housing 17 in which the electronic unit 3 is mounted. The rest of the configuration is the same as that in Embodiments 1 and 2, and those components will be numbered the same and will not be described in detail.
The wearable sensor device 1 comprises the electronic unit 3, the sensor 5, the electronic unit housing 17, and the hinge mechanism 58.
At least part of the sensor 5 is inserted into the patient's body, and the sensor 5 has a sensor connection terminal (first connection terminal) 7.
The mount unit 6 has at least a part of the sensor connection terminal 7 of the sensor 5 disposed thereon, and is attached to the skin of the patient's body.
The electronic unit housing 17 is mounted on the mount unit 6 via the hinge mechanism 58 serving as a mounting mechanism.
The electronic unit 3 is removably attached to the electronic unit housing 17, and has the second connection terminal 10 connected to the sensor connection terminal 7, and a control unit that calculates biometric information from signals inputted from the sensor 5 (see
The hinge mechanism 58 (mounting mechanism) forms a first state in which the mount unit 6 and the electronic unit housing 17 are attached to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state in which the mount unit 6 and the electronic unit housing 17 are attached to each other in a state where the second connection terminal 10 and the second connection terminal 10 are connected to each other.
As shown in
An insertion opening 9 into which a part of the sensor connection terminal 7 is fitted is provided on the bottom surface side of the electronic unit 3. The insertion opening 9 is provided with the second connection terminal 10 that connects to the sensor connection terminal 7.
An O-ring 11 is provided as a waterproof member around the periphery of the insertion opening 9. The O-ring 11 is disposed so as to be sandwiched between the electronic unit 3 and the mount unit 6 when the electronic unit 3 and the mount unit 6 are linked together. As a result, the O-ring 11 functions as a waterproofing mechanism that prevents the intrusion of water or the like into the sensor connection terminal 7 and the second connection terminal 10.
The wearable sensor device 1 further comprises locking mechanisms 12 and 13 that fix the electronic unit 3 and the mount unit 6 in order to keep the electronic unit 3 and the mount unit 6 in a linked state (the second state). The locking mechanisms 12 and 13 have snap fits 12a and 12b provided on the mount unit 6 side, and insertion openings 13a and 13b provided on the electronic unit 3 side. In a state in which the electronic unit 3 and the mount unit 6 are linked to each other, the snap fit 12a and the insertion opening 13a, and the snap fit 12b and the insertion opening 13b are mated to each other. As a result, the linked state of the electronic unit 3 and the mount unit 6 is maintained.
The bottom surface of the mount unit 6 serves as an adhesive surface that is attached to the skin of the upper arm 2 or the like. An adhesive material such as a skin tape is provided on the bottom surface of the mount unit 6 to facilitate adhesion to the skin. When coupling the locking mechanisms 12 and 13, it is necessary to apply a downward force from above. Consequently, when a downward force is applied in coupling the locking mechanisms 12 and 13, this causes the bottom surface of the mount unit 6 to be pressed against the skin. As a result, the wearable sensor device 1 is more securely attached to the skin of the upper arm 2.
The electronic unit housing 17 and the mount unit 6 are rotatably linked by the hinge mechanism 58.
When the electronic unit housing 17 and the mount unit 6 are coupled (face to face), the electronic unit housing 17 is coupled so as to rotate with the hinge mechanism 58 as its fulcrum.
Here, the angle formed by the mount unit 6 and the electronic unit housing 17 around the hinge mechanism 58 is defined as the rotation angle.
Thus, the electronic unit housing 17 and the mount unit 6 are linked to each other by the hinge mechanism 58. The hinge mechanism 58 forms the first state in which the mount unit 6 and the electronic unit housing 17 (electronic unit 3) are attached to each other in a state where the sensor connection terminal 7 linked to the sensor 5 and the second connection terminal 10 provided on the electronic unit 3 side have yet to be connected.
This first state is a state in which the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected to each other, as shown in
Furthermore, the hinge mechanism 58 forms the second state in which the mount unit 6 and the electronic unit housing 17 (electronic unit 3) are mounted in a state where the sensor connection terminal 7 linked to the sensor 5 and the second connection terminal 10 provided on the electronic unit 3 side have been connected.
This second state is a state in which the sensor connection terminal 7 and the second connection terminal 10 are connected to each other, as shown in
Thus, in this embodiment, the hinge mechanism 58 forms a first state in which the mount unit 6 and the electronic unit housing 17 (electronic unit 3) are mounted to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected to each other, and a second state in which the mount unit 6 and the electronic unit housing 17 (electronic unit 3) are mounted to each other in a state where the sensor connection terminal 7 and the second connection terminal 10 have been connected. This makes it easy to attach the wearable sensor device 1 to the patient's body.
That is, after the sensor 5 is inserted into the body, the electronic unit 3 is mounted on the mount unit 6 by the simple operation of rotating the electronic unit housing 17 with respect to the mount unit 6 via the hinge mechanism 58 to go from the first state to the second state. Therefore, the wearable sensor device 1 can be easily attached to the patient's body.
Consequently, even if the place where the sensor is to be attached cannot be seen (such as the outside of the upper arm part 2), the electronic unit housing 17 can be mounted to the mount unit 6, and the sensor connection terminal 7 and the second connection terminal 10 can be connected, by the simple operation of rotating the electronic unit 3 via the hinge mechanism 8. As a result, the wearable sensor device 1 is easy to attach to the patient's body.
Since the mount unit 6 and the electronic unit 3 are rotatably linked together via the hinge mechanism 8, there is no need to grasp the relatively small electronic unit 3 to attach it to the mount unit and the sensor. As a result, it is easy to attach the wearable sensor device 1 to the body.
Further, the hinge mechanism 58 is provided with an elastic body as described above. The elastic body is configured to bias the electronic unit 3 in the direction of mounting to the mount unit 6.
In this embodiment, the elastic body is constituted by the spring unit 16 provided to the hinge mechanism 58. The spring unit 16 is formed integrally with the hinge portion 15 using a resin or other such material. Therefore, the hinge mechanism 58 having an elastic body can be formed without increasing the number of parts.
Consequently, as shown in
As a result, the user can create a state in which the electronic unit housing 17 is mounted on the mount unit 6 simply by lightly pressing the electronic unit housing 17 from above with a finger as shown in
Also, since the electronic unit housing 17 covers the sensor connection terminal 7 disposed on the mount unit 6 as shown in
The elastic body may be a torsion spring provided to the hinge mechanism, or may be a leaf spring.
Furthermore, a through-hole 14 through which passes a needle for puncturing the skin and inserting the sensor 5 into the body is provided above the sensor 5 of the mount unit 6.
In this embodiment, the electronic unit housing 17 is detachably attached to the mount unit 6 via the hinge mechanism 8 serving as a mounting mechanism. The electronic unit 3 is removably attached to the electronic unit housing 17.
Consequently, the electronic unit 3 can be attached to the mount unit 6 after the electronic unit housing 17, the mount unit 6, and the sensor 5 attached to the mount unit 6 have been sterilized, which allows sterilization to be carried out in a state in which the electronic unit 3 has been separated.
Here, the reason for performing the sterilization with the electronic unit 3 separated is that the electronic unit 3 cannot be sterilized when electron beam sterilization is employed, for example, and therefore the electronic unit 3 must be separated from the member to be sterilized. Accordingly, because the electronic unit housing 17 is detachably mounted on the mount unit 6 via the hinge mechanism 8, sterilization can be performed with the electronic unit 3 in a separated state.
The configuration of the sensor insertion device 25 according to yet another embodiment of the present invention will now be described.
With the sensor insertion device 25 of this embodiment, the form of a support unit 130 that supports the electronic unit 3 differs from the support unit 30 in the above embodiments. The rest of the configuration is the same as in the above embodiments, and components that are the same will be numbered the same and detailed description thereof will be omitted.
As shown in
The sensor insertion mechanism 29 has a puncture needle 32, a puncture needle holder 33, and a drive unit 34 that drives the puncture needle holder 33 downward in the puncturing direction, and pulls up the puncture needle holder 33 after the puncture to withdraw the puncture needle 32 from the skin.
Just as in Embodiment 1, this sensor insertion mechanism 29 will not be described in order to avoid complicating the overall description.
The support unit 130 is provided as a side surface of the puncture needle holder 33 in the upper case 26, and in the state shown in
The description will now return to
Inside the upper case 26, the mount unit 6 of the wearable sensor device 1 is held by the holding unit 31 in the lower part of the upper case 26. The puncture needle 32 is in a state in which the sensor 5 is included therein.
The electronic unit 3 connected to the mount unit 6 by the hinge mechanism 8 is in a state of being supported by the support unit 130.
The electronic unit 3 connected to the mount unit 6 by the hinge mechanism 8 is supported by the support unit 130. The electronic unit 3 is rotatably linked to the mount unit 6 by the hinge mechanism 8. Therefore, the support unit 130 only needs to support the electronic unit 3 so as not to rotate.
Here, the support unit 130 of the electronic unit 3 is fixed to the puncture needle holder 33, so when the puncture needle holder 33 is lifted up, the support unit 130 is also lifted up, and the support of the electronic unit 3 is released. That is, the electronic unit 3 is supported by the support unit 130 in the above-mentioned first state until the sensor 5 is to inserted into the patient's body. Then, after the sensor 5 has been inserted into the body, the support unit 130 releases its support of the electronic unit 3.
Consequently, the mount unit 6 and the electronic unit 3 of the wearable sensor device 1 can form a first state of being mounted in a state where the sensor connection terminal 7 and the second connection terminal 10 have yet to be connected, and a second state of being mounted in a state where the connection terminal 7 and the second connection terminal 10 have been connected. As a result, the wearable sensor device 1 easily attached to the patient's body.
That is, in the configuration of this embodiment, after the sensor 5 is inserted into the body, the support of the electronic unit 3 by the support unit 130 is released, there is a change from the first state to the second state, and the electronic unit 3 is mounted on the mount unit 6. As a result, the wearable sensor device 1 can be easily attached to the patient's body.
In this embodiment, in addition to the configuration of the sensor insertion device 25 of the above-mentioned Embodiments 1 and 2, a configuration in which the electronic unit 3 and the mount unit 6 are rotatably mounted via the hinge mechanism 8 was also described as an example.
However, the present invention can be similarly applied to a configuration in which the electronic unit housing 17 and the mount unit 6 are rotatably mounted via the hinge mechanism 8. In this configuration, the support unit 130 is configured to support the electronic unit housing 17.
The wearable sensor device of the present invention is very much expected to be applied to a blood glucose level sensor in a continuous blood glucose measurement system, for example.
Number | Date | Country | Kind |
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2018-108631 | Jun 2018 | JP | national |
2018-108669 | Jun 2018 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2019/022185 | 6/4/2019 | WO | 00 |