JP2000116626A5 - - Google Patents

Description

[Claims]
[Claim 1]
It is a body fluid measuring device equipped with a main body and a mounting body to be attached to and used on this main body.
The main body is a terminal that contacts and conducts to each electrode of a sensor included in the wearable body when the wearable body is mounted, and an electron that determines a measured value based on an electric signal obtained through the terminal. It is equipped with a circuit and a drive mechanism for driving the puncture body forward and causing the puncture body to take an advanced position.
The wearing body has a sensor having a skin contact portion and a puncture body capable of moving between an advance position where the tip protrudes toward the skin contact portion and a retracted position where the tip is immersed from the skin contact portion. I have
The sensor, through only the skin contact portion in contact with the skin, and that it is arranged at an angle of 5-90 degrees for tangentially at the contact portion between the skin contact portion in the skin A featured body fluid measuring device.
2.
The body fluid measuring device according to claim 1, wherein the wearing body is formed with an opening for applying a negative pressure to the skin.
3.
It is a body fluid measuring device equipped with a main body and a mounting body to be attached to and used on this main body.
The main body is a terminal that contacts and conducts to each electrode of a sensor included in the wearable body when the wearable body is mounted, and an electron that determines a measured value based on an electric signal obtained through the terminal. It is equipped with a circuit and a drive mechanism for driving the puncture body forward and causing the puncture body to take an advanced position.
The wearing body includes a sensor having a skin contact portion, a puncture body capable of moving between an advance position where the tip protrudes near the skin contact portion and a retracted position where the tip is immersed from the skin contact portion . It has an opening for applying negative pressure to the skin ,
The skin contact portion, characterized in that it is arranged in the vicinity of the upper KiHiraki port, the body fluid measuring apparatus.
4.
The attached body further includes an elastic body for urging the puncture body toward the retracted position side.
The body fluid measuring device according to any one of claims 1 to 3, wherein the elastic body is integrally molded with the puncture body.
5.
The attached body further includes an elastic body for urging the puncture body to the retracted position side, and the puncture body is punctured in a state where the punctured body is stationary on the retracted position side. The body fluid measuring device according to any one of claims 1 to 4, wherein the needle is configured to retract and be protected in an elastic body.
6.
The body fluid measuring device according to any one of claims 1 to 5, wherein the attached body has a cap shape as a whole.
7.
The sensor in the mounting body has a plate shape as a whole, and a body fluid passage facing the reaction portion is formed on the inner surface in the thickness direction thereof, and the sensor has a body fluid passage.
The skin contact portion is configured to constitute the body fluid suction port communicating with the fluid passage are placed in the vicinity advanced position of the tip of the lancet, the body fluid measuring apparatus according to any one of claims 1 to 6 ..
8.
The sensor in the mounting body was superposed on the base plate in which the working electrode and the counter electrode were formed on the upper surface, and the base plate so as to face each part of the working electrode and the counter electrode to form a groove. It is composed of a spacer, a reaction portion in which a reaction reagent layer is formed in a part or all of the groove, and a cover plate superposed on the spacer, and a space surrounded by the groove and the cover plate is a body fluid. The body fluid measurement according to claim 7, wherein a terminal portion that forms a passage and is electrically connected to the working electrode and the counter electrode and is brought into contact with the terminal of the main body is arranged at an appropriate portion on the upper surface of the base plate. apparatus.
9.
The sensor in the mounting body includes a base plate having a working electrode formed on the upper surface, a spacer superposed on the base plate so as to face a part of the working pole and forming a groove, and a spacer superposed on the spacer. The cover plate is formed with a counter electrode facing the groove on the lower surface thereof, and the first reaction portion having the first reagent layer formed in the groove so as to be in contact with the working electrode is in contact with the counter electrode. A second reaction portion having a second reagent layer formed on the lower surface of the cover plate is provided, and the space surrounded by the groove and the cover plate forms a body fluid passage, while the above action. A first terminal portion that conducts with the pole and is brought into contact with the terminal of the main body is arranged at an appropriate portion on the upper surface of the base plate, and a second terminal portion that conducts with the counter electrode and is brought into contact with the terminal of the main body. The body fluid measuring device according to claim 7, wherein the body fluid measuring device is arranged on the upper surface of the cover plate.
10.
The body fluid measuring device according to claim 9, wherein the cover plate is formed of a conductor plate, the lower surface thereof functions as a counter electrode, and the appropriate upper surface portion functions as a second terminal portion.
11.
The terminal in the main body is movable between an advance position in which the tip protrudes from the main body and a retracted position in which the tip protrudes from the advance position, and is always urged in the advance direction by a spring. The body fluid measuring device according to any one of 1 to 10.
12.
A body fluid measuring device according to any one of claims 1 to 11, which is mounted on a main body and used.

The body fluid measuring device provided by the present invention is a body fluid measuring device including a main body and a mounting body to be attached to and used on the main body, and the main body is the mounting body when the mounting body is mounted. A terminal that contacts and conducts to each electrode of the sensor provided in the sensor, an electronic circuit that determines a measured value based on an electric signal obtained through this terminal, and a forward drive of the puncture body to the puncture body. The body is provided with a drive mechanism for taking an advance position, and the wearing body has a sensor having a skin contact portion, and an advance position where the tip protrudes near the skin contact portion and the tip is immersed from the skin contact portion. It relates to a body fluid measuring device provided with a puncture body that can move between the retracted position and an attached body in such a body fluid measuring device, and the gist thereof is that the sensor is used only for the skin contact portion. It is to come into contact with the skin through. By arranging the sensor in this way, there is no room for blood to enter between the skin and the part other than the skin contact portion, and the flow path of the discharged blood is limited to the body fluid passage of the sensor. Can be done.

The wearer is provided, for example, as a disposable consumable. In the measurement, the user attaches the above-mentioned body to the main body. If while pressing the skin contact portion in the skin such as the fingertip or earlobe Ru actuates the drive mechanism of the body, scratches its tip from the skin contact surface puncture body in the retracted position is caused to advance projects to the skin Attach. At the next moment, the puncture body returns to the retracted position by the action of the elastic body. If the device is left in place, the blood effluent from the skin will permeate the sensor and the sensor will output a reaction current. This current is converted into a specific component concentration in blood by an electronic circuit and displayed on a display arranged on the surface of the main body, for example.

The skin contact portion of the sensor incorporated in the wearing body simultaneously constitutes a body fluid suction port. Then, the skin contact portion is arranged so as to be near the advance position of the puncture body. The term "neighborhood" as used herein refers to the proximity of the puncture body to the extent that it comes into contact with the body fluid suction port as soon as the puncture body damages the skin and the discharged blood forms a blood droplet. For example, if the blood required for measurement is 1 μl (assuming that 1 μl is a cube with a side of 1 mm), the fluid suction port needs to be arranged at least within 1 mm from the advance position of the puncture body.

According to this structure, together with the work for electrode or the counter electrode by such subjected to screen printing base plate can be easily formed by a simple method of laminating plate-shaped parts, the body fluid passage inside the thickness direction It is possible to easily manufacture a plate-shaped sensor in which is properly formed.

The terminal portions 36f and 36h and the main body 20 for the working pole 36c and the counter electrode 36d exposed at the end of the base plate 36A of the plate-shaped biosensor 36 are formed by bringing the tip of the connector pin 25a into contact with the terminal portions 36f and 36h. It is electrically connected.

On the other hand, a pair of pin connectors 25 are incorporated in the tubular portion 21 of the main body 20 so that the tip of the connector pin 25a elastically protrudes from the front surface of the tubular portion 21. The pin connector 25 is connected to the electronic circuit 33 as shown in FIG. This electronic circuit 33 is composed of a microcomputer or the like, and as will be described later, a calibration curve is used to measure a measured value of a substance to be detected such as a blood glucose level from an action current generated by an enzymatic reaction and an electrochemical reaction generated in the biosensor 36. At the same time as deciding, it has a function to display this on the display 22 arranged on the surface of the main body 20. Further, as shown in FIGS. 2 and 3, the pressing rod 32, which is pressed and driven by the pressing portion 23, is movable in the axial direction (direction indicated by the arrow in the drawing) and is movable in the main body 20. The drive mechanisms 23 and 32 are constructed by being incorporated while being constantly urged to the rear side by a spring. The drive mechanisms 23 and 32 are not limited to this, and a pressing rod 32 is provided so as to be movable in the axial direction and elastically return to the neutral position in the axial direction, and the pressing rod 32 is pulled backward. By holding the latch and pressing the latch release button, the pressing rod 32 is vigorously fired forward, and the pressing rod 32 vigorously hits the rear end of the guide shaft portion 31a of the puncture body 31, and the puncture needle 31c is accompanied by this. Can be configured to momentarily project from the skin contact surface 35a. Further, by incorporating a suction cylinder mechanism (not shown) in the main body 20, it is possible to apply a negative pressure to the tip of the tubular portion 21. Further, the terminal provided on the main body 20 so as to make conductive contact with the terminal portion of the biosensor 36 when the mounting body 30 is mounted on the main body 20 is in the form of a pin connector in which the pin always protrudes elastically as described above. For example, in conjunction with the mounting of the mounting body 30 on the main body 20, the terminal pin is retracted into the main body when the mounting body 30 is not mounted, and when the mounting body 30 is mounted, the terminal pin is moved to the main body. It is also possible to configure the biosensor so that it protrudes from the terminal and makes an appropriate conductive contact with the terminal portion of the biosensor.

The attachment body 30 is provided as a disposable consumable item, and when using the body fluid measuring device 10, the user attaches the attachment body 30 to the tubular portion 21 of the main body 20 (see FIG. 1). Since the mounting body 30 has a cap shape in the above embodiment, such mounting work can be easily performed. When the mounting body 30 is mounted, the tip of the connector pin 25a on the main body side automatically contacts the electrode portions 36f and 36h arranged on the upper surfaces of both ends of the base plate 36A of the biosensor 36 as shown in FIG. ..

The pressing portion 23 is pressed while the end surface 35'of the bottom wall portion 35 of the wearing body 30 and the skin contact portion 37 of the biosensor 36 are pressed against an appropriate part of the patient's skin, for example, a fingertip or an earlobe. Then, the tip of the pressing rod 32 inside the main body 20 pushes the rear end of the guide shaft portion 31a of the puncturing body 31, and the puncturing body has a stroke until the pressing rod 32 comes into contact with the back side of the depressed portion 35A of the mounting body 30. Push 31 forward against the elasticity of the elastic body 37. At this time, the puncture needle 31c of the puncture body 31 punctures the vicinity of the skin contact portion 37 of the biosensor 36 to damage the skin and allow blood to flow out. When the pressure on the pressing portion 23 is released, the pressing rod 32 returns to its original position by the elasticity of the spring, and the puncture body 31 also immerses the puncture needle 31c from the skin contact portion 37 by the elasticity of the elastic body 37. Return to the retracted position.

The protrusion of the puncture needle 31c causes an appropriate wound on the skin, and the blood discharged from the wound is introduced into the body fluid passage 36b in the biosensor 36 via the skin contact portion 37 by the capillary phenomenon. The skin contact portion 37 is located at the position where the puncture needle 31c advances, that is, very close to the wound on the skin and therefore the liquid discharge portion. Then, as described above, since the parenchymal volume of the body fluid passage 36b in the biosensor 36 is extremely small, it is possible to fill the body fluid passage 36b with a small amount of blood. Therefore, the above operation is performed while the skin contact portion 37 is pressed against the skin, and the state where the skin contact portion 37 is pressed against the skin is maintained for a predetermined time without having to visually check the blood volume of the fluid discharge portion one by one. Only by doing so, sufficient blood necessary for measurement can be introduced into the body fluid passage 36b in the sensor. As described above, the suction cylinder mechanism is added to the body, when the operation described above while applying a negative pressure to the skin through the opening 35e (and the through hole 35f), at puncture puncture needle 31c skin congestive states Since it can be scratched, a more sufficient amount of blood can be discharged.

Electronic circuit 33 of the measuring apparatus body 20, the working electrode current is measured this time, and calculates and determines the glucose concentration (blood sugar level), preferably in the LCD display 22 disposed on the surface of the body 20 for example indicate.

As described above, according to the body fluid measuring device 10, after making a simple preparation for mounting the wearing body 30 on a predetermined portion of the main body 20, the end face 35'of the mounting body 30 and the skin contact portion of the biosensor 36 While maintaining the state in which 37 is pressed against the patient's fingertips, ear pads, etc., the operation of protruding the puncture needle 31c as if handling a conventional lancet requires further operation or operation. It is possible to properly measure body fluids such as blood glucose level.

In the biosensor 36 having the structure of FIGS. 6 to 11, as shown in the figure, the reaction reagent layer 361k containing potassium ferricyanide is brought into contact with the working electrode 36c formed on the base plate 36A (first reaction section). On the other hand, the reaction part 36k is formed by forming a reaction reagent layer 362k (second reaction part) containing glucose oxidase which is an oxidase and potassium ferricyanide as a mediator on the inner surface of the cover body 36C. Is also possible. In this way, a biosensor 36 of this type that detects the working pole current via an enzymatic reaction and an electrochemical reaction enables more accurate measurement without the influence of ascorbic acid.

[Simple explanation of drawings]
FIG. 1
It is an overall external view of the body fluid measuring apparatus which concerns on this invention.
FIG. 2
It is an enlarged vertical sectional view which shows the detail of the wearing body.
FIG. 3
It is an enlarged vertical sectional view which shows the detail of the wearing body of another aspect.
FIG. 4
It is a top view of the state which disassembled the sensor.
FIG. 5
It is a vertical sectional view of a sensor.
FIG. 6
It is a vertical sectional view of a sensor.
FIG. 7
It is a vertical sectional view of a sensor.
FIG. 8
It is a schematic block diagram for demonstrating the electrical configuration.
FIG. 9
It is a vertical sectional view of a sensor.
FIG. 10
It is a vertical sectional view of a sensor.
FIG. 11
It is a vertical sectional view of a sensor.
[Explanation of symbols]
10 Body fluid measuring device 20 Main body 23 Pressing part (constituting a drive mechanism)
25a connector pin (as a terminal on the main unit)
30 Wearing body 31 Puncture body
31d Elastic body 32 Pressing rod (constituting a drive mechanism)
33 Electronic circuit 36 Sensor 36A Base plate (constituting the sensor)
36B spacer (constituting the sensor)
36C cover plate (constituting the sensor)
36b Body fluid flow path (of sensor)
36c working pole (of the sensor)
36d counter electrode (of sensor)
36e groove (of the sensor)
36k reaction section (sensor reaction reagent layer)
36f, 36h terminal (as sensor electrode)
361k 1st reaction part (reaction reagent layer of sensor)
362k 2nd reaction unit (reaction reagent layer of sensor)
37 Skin contact area (sensor (body fluid suction port))

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