Blood sensor and blood test apparatus having the same

The present invention relates to a blood sensor and a blood test apparatus having the same.

Diabetic patients need to measure their blood glucose level (glucose level) on a regular basis and inject insulin based on that blood glucose level to maintain their blood glucose level normal. In order to maintain this blood glucose level normally, it is necessary to constantly measure the blood glucose level, and for that purpose, a small amount of blood is collected from the fingertips of the patient using a blood test device, and the collected blood and it are examined. Blood glucose level is measured by a blood sensor.

FIG. 35 shows a cross-sectional view of an example of a conventional blood sensor (see Patent Document 1 and the like). The blood sensor 1 shown in FIG. 35 is composed of a substrate 3; a spacer 4 provided on the upper surface of the substrate 3; and a cover 5 provided on the upper surface of the spacer 4. A blood reservoir 6 is provided through the substrate 3 and the spacer 4, and the reservoir 6 opens toward the side that comes into contact with the skin (lower part of the drawing). One end of the blood supply path 8 is connected to the reservoir 6 and the other end is connected to the air hole 9. A blood detection unit 2 is formed in the blood supply path 8, and a reagent 10 is placed in the detection unit 2.

FIG. 36A is a perspective plan view of the blood sensor 1 viewed from above (from the side of the cover 5). In the blood sensor shown in FIG. 36A, the working electrode 14b and the counter electrode 14c act as detection electrodes to form the detection unit 2. The blood sensor shown in FIG. 36B is also known (see Patent Document 2). In the blood sensor shown in FIG. 36B, the working electrode 14b and the counter electrode 14c act as detection electrodes to form the detection unit 2.

In FIG. 37, how to use the blood sensor 1 will be described. FIG. 37 shows a state in which the needle 11 is pulled up and stopped at the original position after the blood collection is completed. First, the sensor 1 is brought into contact with the skin 7 such as a patient's finger. Next, the puncture needle 11 is fired in the direction of the arrow 12. The puncture needle 11 breaks through the cover 5 forming the top surface 6a of the reservoir 6, forms a puncture hole 14 in the top surface 6a, and further penetrates the puncture hole 14 to damage the skin 7. Blood 13 drains from the injured skin 7. The spilled blood 13 fills the reservoir 6. The blood 13 that fills the reservoir 6 is guided to the detection section 2 through the supply path 8 by a capillary phenomenon.

After that, the blood 13 between the working electrode 14b and the counter electrode 14c reacts with the reagent 10 to generate a current proportional to the blood glucose level. The generated current is guided to the measurement circuit of the blood test apparatus via the connector that contacts the connection electrode 15b and the connector that contacts the connection electrode 15c. A current proportional to the blood glucose level is measured by the measurement circuit, and the blood glucose level is obtained. Based on the obtained blood glucose level, basic data of the amount of insulin to be administered to the patient and the like are provided.

In order to measure the blood glucose level using the blood sensor 1 in this way, the signals of the detection electrode 14b and the detection electrode 14c must be reliably transmitted to the measurement circuit of the blood test apparatus via the connector.<patcit num="1"><text>Japanese Patent Application Laid-Open No. 2005-110712</text></patcit><patcit num="2"><text>Japanese Unexamined Patent Publication No. 2000-000231</text></patcit>

<p> When a conventional blood sensor is attached to a blood test device, the connector and location of the blood test device In order to make contact at the desired position, it was necessary to adjust the mounting angle and the like. Particularly in recent years, in addition to working electrodes and counter electrodes, detection electrodes and Hct poles (described later) have also been adopted as detection electrodes for blood sensors. Therefore, in order to properly connect the connector to each of the connection electrodes of each detection electrode, it is necessary to adjust the mounting angle and the like more precisely. For example, when a substantially circular blood sensor is randomly attached to a blood test device, it is unclear whether each of the connecting electrodes has contacted a connector, or it cannot be determined which connector has contacted, and blood glucose. The value cannot be measured. Therefore, it is conceivable to adjust the angle of the blood sensor with reference to a mark or the like, and visually align the blood sensor with the desired mounting position for mounting. However, this mounting work is burdensome for the patient. In particular, it is a heavy burden for diabetic patients with poor eyesight.</p><p> Therefore, an object of the present invention is to provide a blood sensor that can be easily attached to a blood test apparatus.</p>

<p> The blood sensor of the present invention is characterized by having a reference electrode as a reference for identifying each of the plurality of connecting electrodes. For example, the blood sensor of the present invention has a reference electrode whose electrical resistance with one of a plurality of connecting electrodes is adjusted to a predetermined value; or two or more electrically connected to each other via a conductor. Has a reference electrode of.</p>

<p> The blood sensor of the present invention is provided with a reference electrode as a reference for identifying each of the plurality of connection electrodes, and each connection electrode is specified with the reference electrode as a reference. Therefore, the connection electrodes can be automatically identified, and it is not necessary to visually adjust the mounting position when mounting the blood sensor as in the conventional case, and the mounting work becomes very easy.</p>

[About blood sensor] The blood sensor of the present invention is a detachable or replaceable member attached to a blood test apparatus. As will be described later, the blood test apparatus has a plurality of connectors for connecting to a blood sensor mounted in a predetermined position.

1A and 1B show cross-sectional views of a blood sensor 20, which is an example of a blood sensor. The blood sensor 20 is formed by the substrate 35. The substrate 35 is composed of a substrate 21; a spacer 22 attached to the upper surface of the substrate 21; and a cover 23 attached to the upper surface of the spacer 22.

The base 35 of the blood sensor 20-1 shown in FIG. 1A is provided with a blood reservoir 24, which opens toward the side to be placed on the skin (lower part of the drawing). The storage unit 24 includes a hole 21a provided in the substrate 21 and a hole 22a provided in the spacer 22. The blood reservoir 24 is preferably located near the center of the substrate 35.

One end of the supply channel 25 is connected to the storage unit 24. The blood stored in the storage unit 24 flows into the supply channel 25 by a capillary phenomenon and is guided to the detection unit 27. The other end of the supply path 25 is connected to the air hole 26.

It is preferable that the reagent 10 is placed on the detection unit 27. The detection unit 27 will be described later, but is, for example, on the substrate 21. Reagent 10 is appropriately selected according to the type of blood component to be measured. When measuring glucose level, add PQQ-GDH (0.1 to 5.0U / sensor), potassium ferricyanide (10 to 200 mM), maltitol (1 to 50 mM), and taurine (20 to 20 to 2.0 wt% CMC aqueous solution). 200 mM) is added and dissolved, and the reagent solution is dropped onto the detection unit 27 and dried to obtain the product.

The cover 23 may be provided with a hole 23a, as in the blood sensor 20-2 shown in FIG. 1B. The puncture needle 32 (described later) penetrates the hole 23a. If the cover 23 is provided with a hole 23a in advance, it is not necessary to make a puncture hole in the cover 23 by the puncture needle 32, so that the force for puncturing is small and damage to the needle tip of the puncture needle 32 is suppressed. Will be done.

[Introduction of blood into the blood sensor] FIG. 2 shows how blood is introduced into the blood sensor 20. First, the blood sensor 20 is brought into contact with the patient's skin 7 (skin such as a finger). The skin 7 is injured by the puncture means provided in the main body of the blood test device. In FIG. 2, the puncture means is the puncture needle 32, but the puncture needle 32 is not particularly limited, and puncture may be performed with, for example, a laser. The puncture needle 32 provided in the blood test device main body is fired in the direction of the arrow. The puncture needle 32 breaks through the cover 23 forming the top surface 24a of the reservoir 24 (if the cover 23 does not have the hole 23a) to form the puncture hole 36. In addition, the puncture needle 32 damages the skin 7. Blood 13 drains from the injured skin 7. The spilled blood 13 fills the reservoir 24. After that, the blood 13 flows into the supply path 27 due to the capillary phenomenon, and the blood 13 is introduced into the detection unit 27.

[Relationship between air hole and puncture hole of blood sensor] The diameter 26a (see FIG. 1A) of the air hole 26 is preferably 50 to 500 μm (for example, 50 μm). This is to prevent excessive blood from flowing out from the air holes 26. Further, the area of the air hole 26 in the blood sensor 20-1 is preferably smaller than the area of the puncture hole 36 (the hole of the cover 23 formed by the puncture needle 32; see FIG. 2). By making the area of the puncture hole 36 larger than the area of the air hole 26, most of the blood 13 excessively collected in the reservoir 24 flows out from the puncture hole 36. On the other hand, since the amount of blood 13 flowing out from the air hole 26 is reduced, the reagent 10 is less likely to be washed away. Therefore, the blood 13 is accurately inspected in the detection unit 27 without the reagent 10 moving from the detection unit 27. Similarly, the area of the hole 23a provided in the cover 23 of the blood sensor 20-2 is preferably larger than the air hole 26.

[About water repellency and hydrophobicity] First, it is preferable that the back surface (the surface to be bonded to the spacer) of the cover 23 corresponding to the "inner surface of the supply path 25" is treated with hydrophilicity. This is because the blood 13 smoothly flows into the supply path 25 due to the capillary phenomenon. Further, it is preferable that the back surface of the cover 23 corresponding to the top surface of the storage portion 24 has weaker hydrophilicity than the back surface of the cover 23 corresponding to the inner surface of the supply path 25. This is to allow the blood 13 to flow into the supply channel 25 more smoothly and at a constant speed. If the blood 13 flows into the supply path 25 at a constant speed and reaches the detection unit 27, the meltability of the reagent 10 does not vary, and the components of the blood 13 can be measured accurately.

The front surface of the cover 23 (the back surface of the surface to be bonded to the spacer) is preferably water-repellent. This is to prevent the blood in the reservoir 24 from excessively flowing out from the air hole 26 or the hole in the cover 23 (for example, the puncture hole 36 by the puncture needle 32 or the hole 23a in the cover). Further, it is preferable that the back surface of the cover 23 corresponding to the top surface of the storage portion 24 has weaker water repellency than the front surface of the cover 23. This is to suppress the outflow of blood in the reservoir 24 more effectively. Suppressing the outflow of blood reduces the amount of blood collected and reduces the burden on the patient.

Of the surfaces of the substrate 21 that come into contact with the skin, at least the periphery of the hole 21a is preferably water-repellent, and the entire surface may be water-repellent. Here, "water repellency" preferably means that the surface free energy is 43 mN / m or less. When the surface of the substrate 21 that comes into contact with the skin is water-repellent, the blood that has flowed out when the puncture needle 32 punctures the skin 7 is easily taken into the reservoir 24.

The degree of hydrophilicity or water repellency is adjusted by applying a hydrophilic treatment or water repellent treatment. In order to increase the hydrophilicity or water repellency, the hydrophilic material or the water repellent material may be mixed with the material of the member constituting the blood sensor 20 or applied to the surface of the member. By adjusting the amount of hydrophilic material or water repellent material to be mixed or applied, the degree of hydrophilicity or water repellency is also adjusted. Further, the hydrophilicity can be weakened by decomposing or removing the hydrophilic material of the hydrophobic material (plastic, for example, polyethylene terephthalate) having the hydrophilic material coated on the surface. Further, the hydrophilic material may be irradiated with UV to adjust its performance.

The blood sensor 20 whose hydrophilicity and water repellency are controlled as described above is produced, for example, by the following method. The upper surface of the cover 23 is subjected to a water repellent treatment in advance, and the lower surface of the cover 23 is subjected to a hydrophilic treatment. On the other hand, the entire surface of the back surface of the substrate 21 (the surface opposite to the surface to be bonded to the spacer) or the periphery of the hole 21a may be treated with hydrophobicity in advance. Next, the substrate 21, the spacer 22, and the cover 23 are bonded together (the spacer 22 is bonded to the hydrophilic treated surface of the cover 23).

[Relationship between storage and supply channel volume] As described above, the blood sensor 20 has a blood storage unit 24 and a supply channel 25, and the volume of the storage unit 24 is 1 to 20 times, preferably 4 to 15 times, more preferably 5 times the volume of the supply channel 25. ~ 7 times. For example, the volume of the reservoir 24 of the blood sensor 20-1 shown in FIG. 1A may be 0.904 μL, and the volume of the blood supply path 25 may be 0.144 μL. In this way, by appropriately controlling the volume ratio between the reservoir 24 and the supply channel 25, the speed of blood flowing through the supply channel 25 can be controlled to be constant; and the flow rate of blood flowing through the supply channel 25 is also controlled. It can be properly controlled so that the blood reacts well with reagent 10 without flushing it and is accurate. Inspection becomes possible.

Further, by controlling the volume ratio of the storage unit 24 and the supply channel 25, their volumes can be reduced. Therefore, the amount of blood collected for the test can be suppressed, and the burden on the patient is also reduced.

[About the thickness of each of the substrate, spacer, and cover] The thickness of the substrate 21, spacer 22 and cover 23 of the blood sensor 20, and their ratios are important for blood collection. First, in order to cause the capillary phenomenon in the supply path 25, the thickness of the spacer 22 is preferably in the range of 0.05 to 0.15 mm (preferably 0.1 mm).

Further, in the blood sensor 20, in order to adjust the volume of the storage portion 24 and the volume of the supply path 25, it is necessary to adjust the thickness of the spacer 22 and the thickness of the substrate 21. The thickness of the substrate 21 is preferably equal to or greater than the thickness of the spacer 22, and is in the range of "thickness of substrate 21: thickness of spacer 22" = 1: 1 to 5: 1 (preferably). It is more preferable that the value is 2.5: 1). Further, it is preferable that the thickness of the cover 23 is smaller than the thickness of the substrate 21 to reduce the overall thickness of the blood sensor 20. Therefore, "thickness of substrate 21: thickness of spacer 22: thickness of cover 23" may be set to 2.5: 1.3: 1 as a guide.

[Disassembled plan view of blood sensor] FIG. 3 shows an exploded plan view of the blood sensor 20-1. As mentioned above, the blood sensor 20-1 has a cover 23 shown in FIG. 3A, a spacer 22 shown in FIG. 3B, and a substrate 21 shown in FIG. 3C.

FIG. 3C shows a plan view of the substrate 21. Although the substrate 21 has an octagonal shape, the shape of the substrate is not particularly limited. The material of the substrate 21 is preferably a resin such as polyethylene terephthalate (PET). The thickness of the substrate 21 is preferably in the range of 0.075 to 0.25 mm (preferably 0.188 mm).

The detection electrodes 28 to 31 and the connection electrodes 28a to 31a connected to the detection electrodes 28 to 31 are integrally formed on one surface of the substrate 21 (the surface to be bonded to the spacer 22). The detection electrodes 28 to 31 and the connection electrodes 28a to 31a are formed by forming a conductive layer by a sputtering method or a vapor deposition method using gold, platinum, palladium or the like as a material, and laser processing the conductive layer. A hole 21a is provided substantially in the center of the substrate 21, and the diameter thereof may be about 2.0 mm.

FIG. 3B shows a plan view of the spacer 22. The thickness of the spacer 22 may be in the range of 0.05 to 0.15 mm (preferably 0.1 mm). The spacer 22 preferably has a polygonal shape such as a substantially cross shape. This is because the connector 47 (not shown) of the blood test device is likely to be arranged in the cross-shaped recess. The hole 22a is provided substantially in the center of the spacer 22 and at a position corresponding to the hole 21a provided in the substrate 21. The diameter of the hole 22a may be the same as the diameter of the hole 11a (about 2.0 mm). A slit 22e is formed from the hole 22a in the direction of the first convex portion 22d having a cross shape, and the slit 22e corresponds to the blood supply path 25. By setting the width of the groove of the slit 22e to 0.6 mm and the length in the flow path direction to 2.4 mm, the cavity of the supply path 25 may be set to about 0.144 μL. Since the test can be performed with a small amount of blood in this way, the burden on the patient is small and there is no fear. The material of the spacer 22 may be a resin such as polyethylene terephthalate (PET).

FIG. 3A shows a plan view of the cover 23. The cover 23 has an approximately cross-shaped shape. , An air hole 26 is provided in the first convex portion 23d having a cross shape, and is provided corresponding to the tip end portion of the supply path 25. The diameter of the air hole 26 is preferably about 50 μm.

The material of the cover 23 is plastic, preferably polyethylene terephthalate. The thickness of the cover 23 may be in the range of 0.05 to 0.25 mm (preferably 0.075 mm).

[About the electrode arrangement of the blood sensor] As described above, the blood sensor 20 is provided with a plurality of detection electrodes, connection electrodes derived from each detection electrode, and a reference electrode. The blood sensor 20 has two or more reference electrodes that are either 1) connected to one of the connecting electrodes with a predetermined resistance value, or 2) connected to each other with a predetermined resistance value (preferably 0). Have.

Further, the plurality of detection electrodes arranged on the blood sensor include at least a "working electrode" and a "counter electrode". The "working electrode" refers to an electrode for measuring a blood component, and the "counter electrode" refers to an electrode that is a pair of the working electrodes. Further, it is preferable that the plurality of detection electrodes arranged on the blood sensor include detection electrodes. The "detection electrode" is an electrode for detecting whether or not blood has been supplied to the detection unit. Further, the plurality of detection electrodes may include an Hct electrode, and the Hct electrode means an electrode for measuring a hematocrit value in blood.

The shape of the blood sensor 20 is preferably circular or polygonal, but is not particularly limited. However, if it is a quadrangle or a hexagon, the yield in manufacturing can be increased. Further, a hexagon is preferable because an inscribed circle can be made large. That is, when the inscribed circles are the same, the hexagon is advantageous because the area is smaller than that of the quadrangle.

4 to 9 are perspective plan views of the blood sensor 20, and 1) an example of electrode arrangement of the blood sensor 20 having a reference electrode connected to any of a plurality of connection electrodes with a predetermined resistance value is shown. On the other hand, FIG. 10 is a perspective plan view of the blood sensor 20, and 2) an example of electrode arrangement of the blood sensor 20 having two or more reference electrodes connected to each other with a predetermined resistance value is shown.

The blood sensor 20a shown in FIG. 4 has an octagonal shape, but may have other shapes. Detection electrodes 28 to 31 are formed from the storage portion 24 toward the air hole 26. The detection electrode 31 as the Hct electrode, the detection electrode 30 as the counter electrode, the detection electrode 28 as the working electrode, (the detection electrode 30 as the counter electrode), and the detection electrode 29 as the detection electrode are arranged in order from the storage portion 24.

A detection unit 27 is formed on the substrate 21, and the reagent 10 is brought into contact with a part of the detection unit 27. The reagent 10 preferably comes into contact with the detection electrode 28 that functions as the working electrode and the detection electrode 30 that functions as the counter electrode, while it preferably does not come into contact with the detection electrode 31 that functions as the Hct electrode.

Corresponding connection electrodes 28a, 29a, 30a and 31a are derived from the detection electrodes 28 to 31, respectively. Each of the connecting electrodes 28a to 31a has a contact portion where two pairs of connectors come into contact with each other. That is, the connection electrode 28a is a contact part consisting of 28c and 28d; the connection electrode 29a is a contact part consisting of 29c and 29d; the connection electrode 30a is a contact part consisting of 30c and 30d; the connection electrode 31a is composed of 31c and 31d. Has a contact site. Each contact portion is arranged on the outer peripheral side of the substrate 21.

Only 29c, the contact area consisting of 29c and 29d, is formed on the insulating member 34. .. Therefore, 29c and 29d are electrically insulated (that is, the connection electrodes 29a and 29c are electrically insulated), although the resistance between them is infinite; on the other hand, 28c and 28d, 30c and 30d, The resistance between 31c and 31d is 0. To electrically insulate the 29c and 29d, the 29c may be placed on an insulating member 34 provided on the connecting electrode 29a; a slit may be provided around the 29c; or from the connecting electrode 29a. The portion including the contact portion 19c may be cut out to insulate.

Further, 29c and 29d may not be insulated from each other, and 28c and 28d, 30c and 30d, and 31c and 31d may be insulated from each other. That is, it can be realized by insulating two pairs (one set) of electrodes of any one of the connection electrodes.

A 29c insulated from the 29d (ie, the connecting electrode 29a) can be used as the reference electrode. When the electrical resistance between pairs at each contact site is measured, only one pair becomes infinite, so the reference electrode 29c can be identified. Based on the identified reference electrode, for example, clockwise, each connection electrode can be identified as a connection electrode 29a, a connection electrode 30a, a connection electrode 31a, and a connection electrode 28a, and a detection electrode connected to each connection electrode. Can identify the function of.

When the blood sensor 20a provided with the reference electrode in this way is mounted on the mounting portion (described later) of the blood test device, it is not necessary to consider the relationship between the connector of the blood test device and the contact site of the blood sensor. Therefore, it is not necessary to visually adjust the mounting angle and the like. Therefore, it becomes easy to install.

The blood sensor 20b shown in FIG. 5 has an octagonal shape, but may have other shapes. The blood sensor 20b has detection electrodes 28 to 31 and connection electrodes 28a to 31a derived from each detection electrode, similarly to the blood sensor 20a. Each of the connection electrodes 28a to 31a is provided with a contact portion 28g to 31g, and the connection electrode 29a is further provided with a reference contact portion 29h in addition to the contact portion 29g, and 29h serves as a reference electrode. The reference contact portion is not limited to the connection electrode 29a, but may be any one of the connection electrodes 28a to 31a. The contact sites 28g to 31g and the reference contact sites 29h are preferably arranged in the vicinity of the outer circumference and at equal angular intervals. For example, a regular pentagon may be formed at sites 28g, 29g, 30g, 31g, and 29h. As described above, the blood sensor 20b may be the same as the blood sensor 20a except that the aspect of the reference contact site is different.

The reference contact site 29h can be identified by measuring the electrical resistance between the contact sites 28g to 31g and the reference contact site 29h, respectively. That is, since the electrical resistance between any of the contact portions of the connection electrodes and the reference contact portion 29h becomes zero, the reference contact portion 29h is specified. With reference to the specified reference contact site (29h in this example), each connection electrode can be specified as the connection electrode 29a, 30a, 31a, 28a clockwise, and the arrangement of the connection electrode can be specified. ..

Since the blood sensor 20b has a contact site 28g to 31g and a reference contact site 29h, the blood test device (described later) to which the blood sensor 20b is mounted has five connectors corresponding to each. In addition, there are five terminals of the blood test device corresponding to each connector.

As described above, when the blood sensor 20b provided with the reference electrode is attached to the attachment portion (described later) of the blood test apparatus, it is necessary to consider the relationship between the connector of the blood test apparatus and the contact portion of the blood sensor. Since there is no such thing, there is no need to visually adjust the mounting angle and so on. Therefore, it becomes easy to install.

The blood sensor 20b'shown in FIG. 6 has a square shape, but may have other shapes. Like the blood sensor 20b, the blood sensor 20b'has detection electrodes 28 to 31, and connection electrodes 28a to 31a derived from each detection electrode. Each of the connection electrodes 28a to 31a is provided with a contact portion 28g to 31g, and the connection electrode 30a corresponding to the counter electrode 30 is provided with a reference contact portion 30h in addition to the contact portion 30g, and 30h is a reference electrode. Become. The identification of each connection electrode is performed in the same manner as in the blood sensor 20b.

The blood sensor 20c shown in FIG. 7 has an octagonal shape, but may have other shapes. The blood sensor 20c has detection electrodes 28 to 31 and connection electrodes 28a to 31a derived from each detection electrode, similarly to the blood sensor 20a. Contact portions 28g to 31g are provided on each of the connection electrodes 28a to 31a. Further, the connection electrode 29a is provided with a reference contact portion 29h in addition to the contact portion 29g, and 29h serves as a reference electrode. The reference contact portion 29h and the contact portion 29g are connected with a predetermined resistance value. The reference contact portion is not limited to the connection electrode 29a, but may be any one of the connection electrodes 28a to 31a. As described above, the blood sensor 20c may be the same as the blood sensor 20a except that the aspect of the reference contact site is different.

The contact sites 28g to 31g and the reference contact sites 29h are preferably arranged near the outer circumference of the blood sensor 20c and at equal intervals. For example, a regular pentagon may be formed at the contact sites 28g, 29g, 30g, 31g and the reference contact site 29h. Therefore, like the blood sensor 20b, the blood test device to which the blood sensor 20c is mounted has five connectors and terminals, respectively.

The contact portion 29g of the connection electrode 29a and the reference contact portion 29h are connected by a pattern (used as an example of a predetermined resistance) 38 processed by a laser beam. By changing the width of the pattern 38, the resistance value between the contact portion 29g and the reference contact portion 29h can be adjusted to a predetermined value. Therefore, the reference contact site 29h can be specified by measuring the electrical resistance between the contact sites 28g to 31g and the reference contact site 29h, respectively. That is, since the electrical resistance between any of the contact portions of each connection electrode and the reference contact portion 29h becomes a predetermined value, the reference contact portion is specified. Based on the identified reference contact site (29h in this example), each connecting electrode can be identified clockwise as the connecting electrodes 29a, 30a, 31a, 28a, and the arrangement of the connecting electrodes can be specified. ..

The reference contact site 29h can be used not only as a reference electrode but also for determining the blood sensor 20c. An example of determining a blood sensor is the calibration line 1 if the resistance value of pattern 38 is 200 ohms to 1000 ohms; the calibration line 2 if the resistance value is 1000 ohms to 2000 ohms; the resistance value is 2000 ohms to 3000 ohms. In the case of, it is set to use the calibration line 3, the blood sensor is judged from the resistance value, and the calibration line to be applied is automatically selected. Further, the product specifications of the shipped blood sensor may be determined based on the difference in the resistance value of the pattern 38, such as the specifications of company A and the specifications of company B. Further, it is also possible to change the oscillation frequency according to the inductance value adjusted by the pattern 38, give the blood sensor 23c various information, and determine the blood sensor from the information.

When the blood sensor 20c having the reference contact site 29h serving as the reference electrode is attached to the attachment part (described later) of the blood test device, it is necessary to consider the relationship between the connector of the blood test device and the contact site of the blood sensor. Since there is no such thing, there is no need to visually adjust the mounting angle and so on. Yo Therefore, it becomes easy to install.

The blood sensor 20d shown in FIG. 8 has a hexagonal shape, but may have other shapes. The blood sensor 20d has detection electrodes 28 to 31, and connection electrodes 28a to 31a derived from each detection electrode. Contact portions 28g to 31g are provided on each of the connection electrodes 28a to 31a. Further, the connection electrode 30a is provided with a reference contact portion 30h used as a reference electrode in addition to the contact portion 30g. The reference contact portion is not limited to the connection electrode 30a, but may be any of the connection electrodes 28a to 31a.

Further, the blood sensor 20d is also provided with a dummy pole 33. The dummy pole is provided for mechanical balance (balance of contact position). A contact portion 33 g is arranged on the dummy pole 33. Therefore, the blood test device to which the blood sensor 20d is mounted has six connectors.

The contact sites 28 g to 31 g, the reference contact sites 30 h, and the contact sites 33 g are preferably arranged near the outer circumference of the blood sensor 20d and at equal angular intervals. For example, a regular hexagon may be formed at sites 28 g to 31 g, 30 h and 33 g.

The reference contact portion 30h can be specified by measuring the electrical resistance between the contact portion 28g to 31g, the contact portion 33g of the dummy pole 33, and the reference contact portion 30h. That is, since the electrical resistance between any of the contact sites and the reference contact site 30h becomes zero, the reference contact site 30h is specified. With reference to the specified reference contact site (30h in this example), each connection electrode is clockwise with the counter electrode connection electrode 30a, dummy electrode 33, Hct pole connection electrode 31a, working electrode connection electrode 28a, and detection electrode. It can be specified as the connection electrode 29a of the above, and the arrangement of the connection electrode can be specified.

The blood sensor 20e shown in FIG. 9A has a regular quadrangle, and the blood sensor 20e'shown in FIG. 9B has a rectangular shape, but other shapes may be used. The blood sensors 20e and 20e'have the detection electrode 28 as the working electrode, the detection electrode 29 as the detection electrode and the detection electrode 30 as the counter electrode, but do not have the detection electrode 31 as the Hct pole. It is different from the blood sensors 20a ~ 20d of.

Further, the blood sensors 20e and 20e'have connection electrodes 28a to 30a derived from each of the detection electrodes 28 to 30, and contact sites 28g to 30g are arranged in each of the connection electrodes 28a to 30a. Further, the connection electrode 29a is provided with a reference contact portion 29h in addition to the contact portion 29g, and 29h serves as a reference electrode. Therefore, four connectors are arranged in the blood test device to which the blood sensor 20e is attached. The sites 28g to 30g and 29h are preferably arranged near the outer circumference of the blood sensor 20e or 20e'and at equal intervals. For example, a regular quadrangle may be formed with a contact portion of 28 g to 30 g and a reference contact portion of 29 h. Further, the reference contact portion is not limited to the connection electrode 29a, but may be any one of the connection electrodes 28a to 30a.

The reference contact site 29h can be identified by measuring the electrical resistance between the contact sites 28g to 30g and the reference contact site 29h, respectively. That is, since the electrical resistance between any of the contact sites and the reference contact site 29h becomes almost zero, the reference contact site 29h is specified. With reference to the specified reference contact site (29h in this example), each connection electrode can be specified clockwise as the connection electrodes 29a, 30a, 28a, and the arrangement of the connection electrodes can be specified.

The blood sensor 20f shown in FIG. 10 has a hexagonal shape, but may have other shapes. The blood sensor 20f has detection electrodes 28 to 31, and connection electrodes 28a to 31a derived from each detection electrode. Contact portions 28g to 31g are arranged on the connection electrodes 28a to 31a, respectively. Further, the blood sensor 20f has an electrode 33, and the reference contact sites 33h and 33h'which serve as two reference electrodes are arranged on the electrode 33. It is preferable that the contact sites 28 g to 31 g and the reference contact sites 33h and 33h'are arranged in the vicinity of the outer circumference and at equal angular intervals. Six connectors are arranged in the blood test device to which the blood sensor 20f is attached.

Since the reference contact portions 33h and 33h', which are the reference electrodes, are connected via a conductor, the resistance between them becomes zero. Therefore, the pair of reference electrodes (33h and 33h') where the resistance between each other becomes zero is specified. With the specified reference electrode as a reference, each connection electrode can be specified as the connection electrodes 31a, 28a, 29a, 30a in a clockwise direction, and the arrangement of the connection electrodes can be specified.

[Blood sensor with mounting guide] The blood sensor 20 preferably has a mounting guide. The attachment guide is a member for attaching the blood sensor 20 to a predetermined position of the blood test device. The predetermined position is a position where each of the plurality of connectors of the blood test device is connected to the contact portion of the connection electrode of the blood sensor and the contact portion serving as the reference electrode. Further, at the predetermined position, each of the plurality of connectors does not come into contact with the boundary between the electrodes of the blood sensor.

Each connector of the blood test device preferably contacts around the axis of the blood sensor mounted in place. The axis of the blood sensor is near the center of the axis rotation of the blood sensor when the mounting direction of the blood sensor is mounted on the mounting portion of the blood test device. Further, the axis of the blood sensor may be near the center of the portion where the blood sensor unit (meaning a blood sensor or a cartridge containing the blood sensor) and the mounting portion of the blood test apparatus main body are engaged with each other. The axis of the blood sensor is usually inside the reservoir 24 on the substrate surface of the blood sensor.

It is preferable that the mounting guide appropriately adjusts the angle around the axis when the blood sensor 20 is mounted on the blood test device. That is, the mounting guide may be 1) a guide that adjusts the angle around the axis of the blood sensor 20 to a value other than an unfavorable value, that is, a guide that prevents the blood sensor 20 from being guided to a specific unfavorable position, 2). It may be a guide that adjusts the angle around the axis of the blood sensor 20 to a predetermined value, that is, selectively guides the blood sensor 20 to a predetermined position.

11 to 15 show an example of a combination of a mounting portion 90 of a blood test device to which a blood sensor 20 integrated with a holder 80 having a mounting guide 81 for preventing the patient from being guided to a specific unfavorable position is mounted. Is shown. Here, the "specific unfavorable position" refers to a position where a connector of a blood test device is arranged at a boundary between electrodes (connecting electrodes, dummy electrodes, etc.) formed on the blood sensor 20. This is because if the connector of the blood test device comes into contact with the boundary between the electrodes of the blood sensor 20, measurement cannot be performed.

On the other hand, FIGS. 16 to 17 show an example of a combination of a blood sensor 20 having a holder 80 that selectively guides the blood sensor 20 to a predetermined position and a mounting portion 90 of a blood test device to which the blood sensor 20 is mounted.

FIG. 11A shows a blood sensor 20d with holder 80-1. The blood sensor 20d is similar to the blood sensor shown in FIG. 8, has a hexagonal shape, and has four connecting electrodes 28a to 31a derived from four detection electrodes and a dummy pole 33. Connection electrode 28a ~ 3 A contact portion of 28 g to 31 g is arranged in each of 1a, a contact portion of 33 g is arranged in the dummy electrode 33, and a reference contact portion 30h serving as a reference electrode is arranged in the connection electrode 30 g. On the other hand, the holder 80-1 is fixedly arranged so as to surround the blood sensor 20d, and has one mounting guide 81 on the inner circumference thereof.

FIG. 11B shows the mounting portion 90-1 of the blood test apparatus to which the blood sensor 20d having the holder 80-1 is mounted. The mounting portion 90-1 has six connectors 47-1 to 47-6 and six mounting guides 91-1 to 91-6 on the outer surface. Both the connector 47 and the mounting guide 91 are arranged at equal intervals, and it is preferable that they are arranged on the same circle.

Six mounting guides 81 may be arranged on the inner surface of the holder 80-1, and one mounting guide 91 may be arranged on the outer surface of the mounting portion 90-1.

11C and 11D show a state in which the blood sensor 20d having the holder 80-1 is attached to the attachment portion 90-1 of the blood test apparatus. Four of the six connectors on the mounting part 90-1 (47-2 or 3, 47-4, 47-5, 47-6 in the figure) are located at the contact points 28g to 31g of the connection electrodes 28a to 31a. One connector (47-3 or 2 in the figure) contacts the reference contact portion 30h formed on the connection electrode 30a, and the remaining one connector (47-1 in the figure) is a dummy. It contacts 33 g of the contact portion formed on the electrode 33. As shown in FIGS. 11C and 11D, interference between the mounting guide 81 on the inner surface of the holder 80-1 and the mounting guide 91 on the outer surface of the mounting section 90-1 causes the connector 47 of the mounting section to become the blood sensor 20d. It is prevented from being placed on the boundary of each connecting electrode.

Then, as described above, the reference electrode 30h can be specified, and each connection electrode can be specified with reference to the reference electrode 30h.

FIG. 12A shows a blood sensor 20d with holder 80-2. The holder 80-2 is similar to the holder 80-1 in FIG. 11A in that the holder 80-2 is arranged so as to surround the blood sensor 20d and has one mounting guide 81 on the inner circumference thereof, but the mounting guide 81 and the blood sensor 20d The positional relationship with is different. Further, the mounting portion 90-2 shown in FIG. 12B is different from the mounting portion 90-1 shown in FIG. 11B in the position of the mounting guide 91. It is preferable that the connector 47 and the mounting guide 91 of the mounting portion 90-2 are arranged at equal intervals and are on the same circle.

When the blood sensor 20d having the holder 80-2 is mounted on the mounting portion 90-2 shown in FIG. 12B, the mounting guide 81 of the holder 80-2 and the mounting guide 81 are mounted as shown in FIGS. 12C and 12D. Interference with the mounting guide 91 of the mounting portion 90-2 prevents the connector 47 of the mounting portion 90-2 from being placed on the boundary of the connecting electrode of the blood sensor 20d.

FIG. 13A shows a blood sensor 20b'with holder 80-3. The blood sensor 20b'is similar to the blood sensor shown in FIG. 6, has a square shape, and has four connecting electrodes 28a to 31a derived from four detection electrodes 28 to 31. Contact portions 28g to 31g are arranged on each of the connection electrodes 28a to 31a, and a reference contact portion 30h serving as a reference electrode is further arranged on the connection electrode 30a. On the other hand, the holder 80-3 has one mounting guide 81 on its inner circumference.

FIG. 13B shows the mounting portion 90-3 of the blood test apparatus to which the blood sensor 20b'having the holder 80-3 is mounted. Mounting 90-3, shown in Figure 13B, has five connectors 4 It has 7-1 to 47-5 and has five mounting guides 91-1 to 91-5 on the outer surface of the mounting part 90-3. It is preferable that the connector 47 and the mounting guide 91 of the mounting portion 90-3 are arranged at equal intervals and are on the same circle.

Five mounting guides 81 may be formed on the inner surface of the holder 80-3, and one mounting guide 91 may be formed on the outer surface of the mounting portion 90-3.

13C and 13D show a state in which the blood sensor 20b'having the holder 80-3 is attached to the attachment portion 90-3 of the blood test apparatus. Each of the four connectors (47-1 or 2, 47-3, 47-4, 47-5 in the figure) out of the five connectors 47 of the mounting portion 90-3 has a contact portion 28g of the connection electrodes 28a to 31a. It contacts ~ 31g and the remaining one connector (47-2 or 1 in the figure) contacts the reference contact site 30h. As shown in FIGS. 13C and 13D, the interference between the protrusion 81 on the inner surface of the holder 80-3 and the mounting guide 91 on the outer surface of the mounting portion 90-3 causes the connector 47 of the mounting portion 90-3 to become a blood sensor. It is prevented from coming into contact with the boundary of the connecting electrode.

FIG. 14A shows a blood sensor 20f with holder 80-4. The blood sensor 20f is similar to the blood sensor shown in FIG. 10, has a hexagonal shape, and has four connecting electrodes 28a to 31a derived from four detection electrodes 28 to 31 and an electrode 33. Contact portions 28g to 31g are arranged on each of the connection electrodes 28a to 31a, and contact portions 33h and 33h'which serve as two reference electrodes are arranged on the electrode 33. On the other hand, the holder 80-4 has one mounting guide 81 on its inner circumference.

FIG. 14B shows the attachment part 90-4 of the blood test apparatus to which the blood sensor 20f having the holder 80-4 is attached. The mounting section 90-4 shown in FIG. 14B has six connectors 47-1 to 47-6 and six mounting guides 91-1 to 91-6 on the outer surface of the mounting section. It is preferable that the connector 47 and the protrusions of the mounting portion 90-4 are arranged at equal intervals and are on the same circle.

Six mounting guides 81 may be formed on the inner surface of the holder 80-4, and one mounting guide 91 may be formed on the outer surface of the mounting portion 90-4.

14C and 14D show a state in which the blood sensor 20f having the holder 80-4 is mounted on the mounting part 90-4 of the blood test device. Four of the six connectors 47 of mounting 90-4 (47-3 to 47-6) each contact the contact sites 28g to 31g of the connection electrodes 28a to 31a; the remaining two connectors (47- 1 and 47.2) contact the two reference electrodes 33h and 33h', respectively.

As shown in FIGS. 14C and 14D, interference between the protrusion 81 on the inner surface of the holder 80-4 and the mounting guide 91 on the outer surface of the mounting 90-4 causes the connector 47 on the mounting to connect the blood sensor 20f. Contact with the electrode boundaries is prevented.

Since the resistance is 0 between the two reference electrodes 33h and 33h', the reference electrode can be specified, and each connection electrode can also be specified.

FIG. 15A shows a blood sensor 20e with holder 80-5. The blood sensor 20e is similar to the blood sensor shown in FIG. 9A, has a square shape, and has connection electrodes 28a to 30a derived from each of the three detection electrodes 28 to 30. Contact portions 28g to 30g are arranged on each of the connection electrodes 28a to 30a, and a reference contact portion 29h serving as a reference electrode is further arranged on the connection electrode 29a. On the other hand, holder 80-5 is blood sensor 20e It is fixedly arranged so as to surround it, and has one mounting guide 81 on the inner circumference thereof.

FIG. 15B shows the mounting portion 90-5 of the blood test apparatus to which the blood sensor 20e having the holder 80-5 is mounted. The mounting portion 90-5 has four connectors 47-1 to 47-4 and four mounting guides 91-1 to 91-4 on the outer surface. It is preferable that the connector 47 and the mounting guide 91 of the mounting portion 90-5 are arranged at equal intervals and are on the same circle.

FIGS. 15C and 15D show a state in which the blood sensor 20e having the holder 80-5 is attached to the attachment portion 90-5 of the blood test device. Three of the four connectors 47 of the mounting section 90-5 (47-1, 47.2 and 47-3 or 4) each contact the contact sites 28g to 31g of the connection electrodes 28a to 30a, and the rest. One connector (47-4 or 3) contacts the reference contact site 29h.

As shown in FIGS. 15C and 15D, the interference between the protrusion 81 on the inner surface of the holder 80-5 and the mounting guide 91 on the outer surface of the mounting 90-5 causes the connector 47 of the mounting 90-5 to become a blood sensor. It prevents contact with the boundary of the 20f connector.

FIG. 16A shows a blood sensor 20d with holders 80-6. The blood sensor 20d is similar to the blood sensor shown in FIG. 8, has a hexagonal shape, has four connecting electrodes 28a to 31a derived from each of the four detection electrodes 28 to 31, and a dummy pole 33. .. A contact portion 28g to 31g is arranged on each of the connection electrodes 28a to 31a, a contact portion 33g is arranged on the dummy electrode 33, and a reference contact portion 33h serving as a reference electrode is arranged on the connection electrode 30a. On the other hand, the holder 80-6 has six mounting guides 81-1 to 81-6 on the inner circumference thereof. The mounting guides 81 are arranged at equal intervals and have a similar shape.

FIG. 16B shows the attachment part 90-6 of the blood test apparatus to which the blood sensor 20d having the holder 80-6 is attached. The mounting section 90-6 shown in FIG. 16B has six connectors 47-1 to 47-6 and six mounting guides 91-1 to 91-6 on the outer surface of the mounting section. The mounting guides 91 of the mounting portions 90-6 are all arranged at equal angle intervals and have the same shape.

FIG. 16C shows a state in which the blood sensor 20d having the holder 80-6 is attached to the attachment portion 90-6 of the blood test device. The mounting guide 81 on the inner surface of the holder 80-6 and the mounting guide 91 on the outer surface of the mounting portion 90-6 are engaged and fixed for mounting. Since the mounting guide 81 and the mounting guide 91 have the same shape at equal intervals, they can mesh with each other at six positions (see FIGS. 17C to 17H). When mounted, four of the six connectors 47 of the mounting section 90-6 (47-1 or 2, 47-3, 47-4, 47-5) are the contact points of the connection electrodes 28a to 31a, respectively. In contact with 28g ~ 31g, one connector (47-2 or 1) contacts the reference contact area 30h and the remaining one connector (47-6) contacts the contact area 33g of the dummy electrode 33.

As shown in FIG. 16, when a holder for selectively mounting the blood sensor 20 in a predetermined position is used, an unfavorable part (connector comes into contact with the boundary of the connection electrode) as shown in FIGS. 10 to 15. The following advantages can be obtained as compared with the case of using a holder that prevents the holder from being attached to the part to be mounted. 1) Each connector can be brought into contact with the connection electrode or the reference electrode without arranging the connectors 47 of the mounting portion 90 of the blood test device on the same circle. 2) Even if the connectors 47 of the mounting part 90 of the blood test device are not arranged at equal intervals, each connector The nectar can be brought into contact with the connection electrode or the reference electrode.

In FIG. 17, the blood sensor 20d with holder 80-6 (FIG. 17A: similar to FIG. 16A) is mounted with connectors 47-1 to 47-6 arranged at non-equal intervals rather than equiangular intervals. The state (6 types) attached to 90-7 (Fig. 17B) is shown (Fig. 17C to H). It can be seen that each of the connectors 47-1 to 6 of the mounting portion 90-7 contacts a predetermined site of the blood sensor 20d regardless of the mounting state.

As described above, the plurality of connectors of the blood test device may be directly contacted with the connection electrode or the reference electrode of the blood sensor, or may be connected via wiring or the like. For example, as will be described later, the blood sensor may be integrated with the holder to form a blood collection cartridge, and wiring from each of the connection electrode and the reference electrode of the blood sensor may be arranged in the holder. The connector of the blood test device may be connected to the connection electrode or the reference electrode of the blood sensor by contacting each of the wirings.

[About blood collection cartridge] The blood sensor 20 may be integrated with the holder and be a part of the blood collection cartridge. The holder of the blood collection cartridge may be given the function as the holder 80 described above.

FIG. 18A is a perspective view schematically showing a blood collection cartridge 61 including an integrated blood sensor 20 and a holder 60, and a mounting portion 41a (having a connector 47) of a blood test device main body to which the blood sampling cartridge 61 is mounted. .. As shown in FIG. 18A, it is preferable that the holder 60 includes the blood sensor 20 and has a protrusion 60a that abuts on the punctured site.

FIG. 18B shows a holder 60 divided into a first holder 60b and a second holder 60c (having a protrusion 60a), and a blood sensor 20 sandwiched between the first holder 60b and the second holder 60c. A blood collection cartridge 61 containing is shown. The first holder 60b, the second holder 60c, and the blood sensor 20 may be separable from each other. The blood collection cartridge 61 is attached to the attachment portion 41a (having the connector 47) of the blood test device.

FIG. 18C shows a holder 60 having a protrusion 60a and a blood collection cartridge 61 including a blood sensor 20 mounted on the holder 60. The holder 60 and the blood sensor 20 may be separable. The blood collection cartridge 61 is attached to the attachment portion 41a (having the connector 47) of the blood test apparatus. If the holder 60 and the blood sensor 20 are separable, the blood sensor alone can be replaced, but the manufacturing process may increase. FIG. 18D shows a holder 60 having a protrusion 60a and a blood collection cartridge 61 including a blood sensor 20 integrally molded with the holder 60 and inseparable. The blood collection cartridge 61 is attached to the attachment portion 41a (having the connector 47) of the blood test device.

FIG. 19A shows a holder 60 having a protrusion 60a and a blood collection cartridge 61 having a blood sensor 20 integrally molded with the holder 60. Further, the blood collection cartridge 61 has each electrode (connection electrode or the like) of the blood sensor 20 and an electrode 63 connected via the wiring 62. Further, the holder 60 is provided with a recess 60d for restricting the mounting position. On the other hand, the mounting portion 41a of the blood test device to which the blood collection cartridge 61 is mounted has a connector 47 and a convex portion 41i for restricting the mounting position. The connector 47 is urged by an elastic body such as a spring and can be pushed into the mounting portion 41a (see 19C to E). The connector 47 can come into contact with the electrode 63 by engaging the convex portion 41i with the concave portion 60d.

The blood collection cartridge 61 and the mounting portion 41a shown in FIG. 19B are arranged at 1) the point where the connector 47 in the mounting portion 41a and the convex portion 41i are not on the same circle, and 2) the holder 60 in the blood collection cartridge 61. It differs from the blood collection cartridge and mounting portion shown in FIG. 19A in that the electrode 63 and the recess 60d are not on the same circle, but the other parts are the same.

FIG. 19C shows the holder 60; the blood sensor 20 integrally molded with the holder 60; the wiring 62 from the connection electrode of the blood sensor 20 provided inside the holder 60; and the exposed electrode 63 connected to the wiring 62. A cross section of the including blood collection cartridge 61 is shown. The connector 47 of the mounting portion 41a is coupled to the electrode 63 connected to the electrode of the blood sensor 20 via the wiring 62. The connector 47 of the mounting portion 41a is urged to the side of the mounting portion (the side of the blood sensor). The connector 47 may be urged by an elastic body 41j (spring or the like) arranged in the device unit 41a.

FIG. 19D shows a state in which the blood collection cartridge 61 is attached to the attachment portion 41a of the blood test apparatus. By engaging the concave portion 60d of the blood collection cartridge 61 with the convex portion 41i of the mounting portion 41a, the blood collection cartridge 61 can be inserted to an appropriate depth and the connector 47 can come into contact with the holder electrode 63. On the other hand, as shown in FIG. 19E, the connector 47 cannot contact the holder electrode 63 unless the concave portion 60d and the convex portion 41i are engaged with each other.

FIG. 20 shows a perspective view of an example of a blood collection cartridge that includes an integrated blood sensor 20, a puncture means (including a lancet and a blood collection needle), and a holder. The height of the cross-shaped convex portion 43c formed on one end 43a side (blood sensor 20 side) of the holder 43 of the blood collection cartridge 42 is the height of the cross-shaped convex portion formed on the other end 43b side of the holder 43. Higher than the height of part 43d. That is, the convex portion 43d side of the holder 43 is thinner than the convex portion 43c side. As described above, when the front portion of the holder of the blood collection cartridge in the insertion direction is thinner than the rear portion, the blood collection cartridge 42 can be easily inserted into the mounting portion of the blood test device. Further, the tip portion 43g (43b side) of the convex portion 43d on the other end 43b side protrudes at an acute angle, and functions as a mounting guide (described above) for the mounting portion of the blood test device.

Since the blood collection cartridge 42 is attached to and detached from the attachment portion in units of the blood collection cartridge 42, the puncture needle 32 and the blood sensor 20 can also be attached to and detached from the attachment portion at once. Therefore, the blood sensor 20 and the puncture needle 32 can be easily attached and replaced.

FIG. 21 shows an assembled perspective view of an example of a blood collection cartridge. The blood collection cartridge 42 was mounted on a cylindrical holder 43; a blood sensor 20 mounted on one end 43a of the holder 43; a lancet 45 slidably provided within the holder 43; a lancet 45 mounted on the other end 45b of the lancet 45. Has a needle 32. On the other hand, the connector 47 is preferably located in the blood test apparatus main body. For example, the blood sensor 20a has 8 connectors (4 pairs of connectors); the blood sensor 20b, 20b'or 20c has 5 connectors; the blood sensor 20d or 20f has 6 connectors; the blood sensor 20e Now, four connectors are placed on the body of the blood test device.

The blood sensor 20 is attached to one end 43a of the holder 43. The outer skin of the holder 43 in FIG. 21 has a cross-shaped shape, and a connector 47 (in the main body of the blood test device) made of conductive metal is guided between the cross-shaped convex portions 43c. Therefore, four connectors are guided to the blood collection cartridge 42.

The other end of the holder 43 has another convex portion 43d integrally formed with the convex portion 43c, and the convex portion 43d is provided with a hole 43e.

The lancet 45 is inserted in the holder 43. The lancet 45 is provided with a guide 45c that is 180 degrees apart from each other to prevent reuse. Further, the lancet 45 is separated from each other by 180 degrees, and a guide 45d for improving linear motion is provided between the guides 45c. The guide 45d is provided so as to slide in the hole 43e. The guide 45c and the guide 45d are integrally formed with the lancet 45. A convex portion 45e is provided near one end 45a of the lancet 45, and a gripped portion 45f is provided between the convex portion 45e and one end 45a.

FIG. 22A is a cross-sectional view of the blood collection cartridge 42 at the time of puncture, and FIG. 22B is a cross-sectional view of the blood collection cartridge 42 at the end of puncture. As shown in FIG. 22A, the puncture needle 32 protrudes from the blood sensor 20 and stops at the time of puncture. At this time, the convex portion 45e of the lancet 45 is locked to the locking portion 43f provided at the other end 43b of the holder 43. Therefore, the puncture needle 32 does not protrude further from the blood sensor. As shown in FIG. 22B, at the end of puncture, the puncture needle 32 is housed in the holder 43 and stopped. The root of the guide 45c of the lancet 45 is locked to a locking portion 43f provided at the other end 43b of the holder 43. Therefore, the lancet 45 does not come off the holder 43.

In the state shown in FIG. 22B, the blood collection cartridge 42 is removed from the mounting portion 41a of the blood test device. In the state shown in FIG. 22B, even if the lancet 45 is accidentally pushed out in the direction of the arrow 55, the guide 45c rides on the convex portion 43c from the hole 43e of the holder 43 by its own elasticity. Then, since the base of the guide 45c engages with the end of the hole 43e and stops, the puncture needle 32 does not protrude from the blood sensor 20 again, which is safe and does not give the patient a feeling of fear.

As described above, the holder 43 of the cartridge 42 preferably has a function as a mounting guide for mounting the blood sensor 20 on the mounting portion 41a of the blood test apparatus. FIG. 23 is a development plan view of a main part showing an example of a mounting guide for mounting the cartridge 42 having the blood sensor 20 on the mounting portion 41a of the blood test apparatus. The convex portion 43d formed on the holder 43 functions as a mounting guide. A convex portion 41f is formed inside the mounting portion 41a of the blood test device. It is preferable that the tip portion 41g of the convex portion 41f and the tip portion 43g of the convex portion 43d have an acute angle.

When the cartridge 42 is mounted, the convex portion 43d and the convex portion 41f face each other, and even if the positions of the convex portion 43d and the convex portion 41f are displaced from each other, the cartridge 42 is mounted while correcting the angle as shown by the arrow 57. As a result, the contact portion arranged on the blood sensor of the cartridge 42 and the connector of the blood test device are surely in contact with each other.

FIG. 24 is a cross-sectional view of the mounting portion 41a of the blood test device to which the cartridge 42 is mounted. As shown in FIG. 24, the cartridge 42 is mounted according to the mounting guide, and the convex portion 41f and the convex portion 43d are engaged with each other, corrected to a predetermined angle, and fixed in the mounting portion 41a. As a result, the connector 47 reliably contacts each contact portion of the blood sensor 20, and the signal of the blood sensor 20 is reliably transmitted to the measurement circuit 52.

FIG. 25 is a cross-sectional view of the cartridge 42 and the mounting portion 41a into which the cartridge 42 is inserted. FIG. 25A shows the plunger 50 retracted rearward, with the puncture needle 32 inside the cartridge 42. That is, it shows the state before puncture. FIG. 25B shows the plunger 50 protruding forward, with the puncture needle 32 breaking through the cover 23 of the sensor 20 and puncturing the patient's skin. FIG. 25C shows the state in which the plunger 50 is pulled backward, and the puncture needle 32 is housed in the cartridge 42. In this way, the plunger 50 moves forward Except for the protruding state, the puncture needle 32 is housed in the cartridge 42.

[About blood test equipment] An example of a blood test device to which the blood sensor 20 is attached will be described. FIG. 26 shows a cross-sectional view of the blood test apparatus 40. The blood test device 40 has a housing 41 made of resin. The housing 41 is a frame of the device and houses the main members of the device.

One of the housings 41 is a mounting portion 41a. It is preferable that the blood collection cartridge 42 is inserted into the end 41b of the mounting portion 41a. The blood collection cartridge 42 inserted into the mounting portion 41a is inside the mounting portion 41a because the positioning recess 41h provided on the mounting portion 41a side and the positioning convex portion 43h provided on the holder 43 on the blood collection cartridge 42 side mesh with each other. Is fixed at a predetermined position (position in the left-right direction in FIG. 26).

The blood collection cartridge 42 includes a cylindrical holder 43, a blood sensor 20 attached to one end 43a of the holder 43, a lancet 45 that can freely slide inside the holder 43, and a puncture attached to the other end 45b of the lancet 45. Has a needle 32. The blood sensor 20 includes a test electrode and a connection electrode connected to the test electrode. The connector 47 comes into contact with the connection electrode.

The gripped portion 45f formed in the vicinity of one end 45a of the lancet 45, which is a member of the blood collection cartridge 42, is gripped by the grip portion 50a provided on one side of the plunger 50 that slides inside the mounting portion 41a. When the plunger 50 grips the lancet 45, when the puncture needle 32 punctures the skin, the puncture needle 32 does not shake and the straightness is improved, and the puncture needle 32 can be stably punctured into the skin.

On the other hand, the other 50b of the plunger 50 is connected to one 51a of the crank-shaped handle 51. A locking protrusion 51c is formed on the other 51b of the handle 51. The handle 51 passes through the hole 41c formed in the housing 41 and is locked by fitting the locking protrusion 51c with the locking recess 51d.

As the driving mechanism of the plunger 50, for example, the method disclosed in Japanese Patent Application Laid-Open No. 2006-314718 can be adopted. According to this method, the puncture needle can be retracted straight and stopped after the puncture, so that the pain to the patient at the time of puncture is minimized, and the patient's skin is pierced twice or three times. A mechanism to prevent multiple punctures and adjustment of the puncture depth can be easily realized. If such a prevention mechanism and an adjustment mechanism are provided not on the blood collection cartridge side but on the blood test device side, the blood collection cartridge can be realized in a small size and at low cost.

An example of a mechanism for preventing multiple punctures is described in JP-A-2006-314718. The other end of the pull spring with one end fixed is hung on a lever provided on the plunger and whose rotation is partially restricted. The plunger is given a forward urging force by the contraction-restoring force of the pull spring. The plunger advances further forward by inertia than the position where it can no longer be urged forward. At that time, the lever is squeezed and the pull spring is extended again, and the plunger is urged toward the rear end by the restoring force. In this way, the urging means for urging the plunger toward the front end direction and the rear end direction is configured by one pulling spring to simplify the manufacturing process of the puncture tool and prevent the puncture needle from being punctured multiple times. (See Gazette).

As an example of the puncture depth adjustment mechanism, when the plunger moves in the axial direction, the puncture depth adjustment knob 84 having a receiving portion that regulates the movement amount is rotatably fitted (see FIG. 34). .. The receiving portion (not shown) of the puncture depth adjusting knob 84 has a spiral shape, and the adjusting knob 84 is used. The amount of movement of the plunger in the axial direction can be changed by rotating the housing 41 with respect to the mounting portion 41a.

The measurement circuit 52 is housed inside the housing 41 on the other side 41e. The measurement circuit 52 is connected to a terminal 53 formed inside the mounting portion 41a. Further, the terminal 53 is connected to the connector 47. The terminal 53 is composed of two or more (usually 4 or 5) terminals 53a to 53d (or 53e), and is connected to the corresponding connectors 47a to 47d (or 47e), respectively. As mentioned above, each of the connectors 47 contacts the corresponding connection electrode. The housing also houses a battery 54 that supplies power to the measurement circuit 52.

As described above, the blood test device 40 has a blood collection cartridge 42 in which a lancet 45 to which the puncture needle 32 is attached and a blood sensor 20 are built and integrated, and the blood collection cartridge 42 is attached to and detached from the attachment portion 41a. sell. Therefore, the puncture needle and the blood sensor can be easily replaced together with the blood collection cartridge 42. In addition, since the blood sensor 20 and the puncture needle 32 are replaced at once for each test, there is no risk of using the puncture needle 32 multiple times, and there is no risk of infection.

Since the puncture needle 32 of the blood collection cartridge 42 is housed inside the holder 43 when attached, the puncture needle 32 does not hurt the patient, is safe, and does not cause fear. Further, the puncture needle 32 housed in the holder 43 is not directly touched, so that it is also hygienic.

[About blood test flow] FIG. 27 shows an example of a test flow using the blood test device 40. In step 61, the blood collection cartridge 42 is inserted into the mounting portion 41a and mounted on the blood test device 40. By this insertion, the holder 43 is press-fitted into the mounting portion 41a and locked, and the positioning concave portion 41h and the positioning convex portion 43h are fitted and positioned. Further, the gripped portion 45f of the lancet 45 is gripped by the gripped portion 50a of the plunger 50.

In step 62, each connecting electrode of the blood sensor 20 is identified. For example, in the case of the blood sensor 20a, the reference electrode 29f is specified by measuring the resistance value between the paired contact sites (28 to 31c and 28 to 31d). Based on the specified reference electrode 29f, the connection electrodes 28a to 31a are specified. As a result, the detection electrodes 28 to 31 are also specified.

In step 63, the blood sensor 20 of the blood collection cartridge 42 is pressed against the patient's skin to bring it into close contact. In step 64, the locking mechanism of the plunger 50 formed by the locking protrusion 51c provided on the handle 51 and the locking recess 41d provided on the housing 41 is released. As a result, the puncture needle 32 attached to the lancet 45 protrudes toward the skin by the plunger 50 urged by the spring.

Immediately after the puncture needle 32 punctures the patient's skin in step 65, the puncture needle 32 is retracted and stored inside the blood collection cartridge 42. Blood is drained and collected in step 66. The spilled blood is taken up by the blood sensor 20 and guided to the detection unit 10 arranged inside the supply path 25. When the detection electrode 29 as the detection electrode determines that the amount of blood required for measurement has been guided to the detection unit, blood collection is completed. In this way, since it is not necessary to collect excess blood more than necessary, the burden on the patient can be extremely lightened. If blood 13 is not detected by the detection unit 27 even after a predetermined time has passed, or if the amount of blood 13 is not appropriate, an alarm means is activated to give an alarm and the content of the treatment is displayed on the display unit. You may.

In step 67, glucose in the collected blood is measured. After reacting glucose in blood with glucose oxidoreductase for a certain period of time, the detection electrode 28 is used as the working electrode and the detection electrode 30 is used. A voltage is applied between the two electrodes with the opposite electrode. Then, the mediator in the reduced state generated on the detection electrode 28 by the enzymatic reaction is oxidized, and the oxidation current is detected. The reaction time of glucose and oxidoreductase is 10 seconds or less; the applied voltage in step 67 is 0.2 to 0.5 V; the applied time is usually 5 seconds or less. This application time is measured by a timer 79 (described later).

In step 68, measure the hematocrit (Hct) value. When a voltage is applied between both electrodes with the detection electrode 31 as the working electrode and the detection electrode 30 as the counter electrode, a current depending on the Hct value is detected. Measure the Hct value based on the detected current. The measured Hct value is used to correct the glucose measurement result. The relationship between the current and the Hct value may be obtained in advance as a calibration curve, or the detected current may be applied as it is.

The applied voltage in step 68 is about 2 to 3 V; the applied time is generally about 5 seconds or less. A mediator is arranged on the detection electrode 31 which is the working electrode, and there is a certain distance between the detection electrode 31 and the detection electrode 30, and only blood is present in this distance. Therefore, in step 68, the oxidation current depending on the Hct value can be detected without being affected by the reagent 10.

Then, in step 69, the measurement result of the blood component is corrected. That is, the Hct value measured in step 68 is used to correct the amount of glucose obtained in step 67. This correction is performed based on a calibration curve (including a calibration table) created in advance. The corrected glucose amount is displayed on the display 75 of the blood test apparatus 40.

After going through the blood glucose measurement steps 67,68,69, the used blood collection cartridge 42 is collected or discarded after each measurement.

[Principle of blood glucose measurement] FIG. 28 shows a measurement principle diagram of the blood test device 40 for measuring the blood glucose level of blood. Glucose 101 in the blood reacts specifically with glucose dehydrogenase (GDH) 103 to give product 102, and potassium ferricyanide 104 is reduced to produce potassium ferrocyanide 105. The amount of potassium ferrocyanide 105 produced is proportional to the concentration of glucose 101. Potassium ferrocyanide 105 is oxidized on the detection electrode 28 as the working electrode (see FIG. 4 and the like), and the oxidation response current 106 flowing through the detection electrode 30 as the counter electrode is proportional to the concentration of glucose 101. Therefore, the blood glucose level can be measured based on the oxidation response current 106.

FIG. 29 shows an output example of the measurement result of the blood test apparatus 20. The horizontal axis is the glucose 101 concentration (mg / dL), and the vertical axis is the response current 106 (μA). Thus, the oxidation response current 106 is proportional to the concentration of glucose 101.

[About the block diagram of the blood test device] FIG. 30 shows a block diagram of the blood test apparatus 52. The same members are designated by the same reference numerals to simplify the description. The blood test device 52 of FIG. 30 has a blood sensor 20b. The connection electrodes 28a to 31a and the reference electrode 29h of the blood sensor 20b are connected to the terminals 53a to 53e via connectors, respectively. The terminals 53a to 53e are connected to the switching circuit 71, and the output of the switching circuit 71 is connected to the input of the current / voltage converter 72. The output of the current / voltage converter 72 is connected to the input of the arithmetic unit 74 via an analog / digital converter (hereinafter referred to as an A / D converter) 73. The output of the calculation unit 74 is connected to the display unit 75 (for example, a liquid crystal display device), and is also connected to the input of the transmission unit 77. Further, a reference voltage source 78 is connected to the switching circuit 71. The reference voltage source 78 may be the ground potential. The output of the control unit 76 is connected to the control terminal of the switching circuit 71, the calculation unit 74, the transmission unit 77, and the timer 79. Alarm means (not shown) may be connected.

When performing a test using a blood test device 52 to which the blood sensor 20b is applied, the connection electrodes 28a to 31a are connected to any of the terminals 53a to 53e (via a connector) before measuring the blood component. It is necessary to identify whether or not. Therefore, among the terminals 33a to 33e, the terminal having continuity between the adjacent terminals is specified by the command of the control unit 76. If a conductive terminal is identified, it is determined that the electrode connected to that terminal is the connection electrode 29a. Based on the terminal connected to the connection electrode 29a, the terminals to be connected to the connection electrodes 30a, 31a, and 28a are determined in order. In this way, after determining the terminals connected to each of the connection electrodes 28a to 31a, the blood component is measured.

Next, the switching circuit 71 is switched, and the detection electrode 28, which is the working electrode for measuring the blood component amount, is connected to the current / voltage converter 72 via the terminal 53. On the other hand, the detection electrode 29, which serves as a detection electrode for detecting the inflow of blood, is connected to the reference voltage source 78 via the terminal 53. A constant voltage is applied between the detection electrode 28 and the detection electrode 29. When blood is introduced into the detection unit in this state, a current flows between the detection electrode 28 and the detection electrode 29. This current is converted into a voltage by the current / voltage converter 72, and the voltage value is converted into a digital value by the A / D converter 73. Then, it is output to the calculation unit 74. The calculation unit 74 detects that blood has flowed in based on the digital value.

Next, the amount of blood component (glucose) is measured. To measure the glucose component amount, first, the switching circuit 71 is switched by the command of the control unit 76, and the detection electrode 28, which is the working electrode for measuring the glucose component amount, is connected to the current / voltage converter 72 via the terminal 53. Connect to. On the other hand, the detection electrode 30, which is the opposite electrode for measuring the amount of glucose component, is connected to the reference voltage source 78 via the terminal 53.

The current / voltage converter 72 and the reference voltage source 78 may be turned off while the glucose in the blood reacts with its oxidoreductase for a certain period of time. After reacting for a certain period of time (10 seconds or less), if a constant voltage (0.2 to 0.5V) is applied between the detection electrodes 28 and 30 according to the command of the control unit 76, it is possible to apply a constant voltage (0.2 to 0.5V) between the detection electrodes 28 and 30. Current flows through. This current is converted into a voltage by the current / voltage converter 72, and the voltage value is converted into a digital value by the A / D converter 73 and output to the arithmetic unit 74. The calculation unit 74 converts the amount of glucose components based on the digital value.

After measuring the amount of glucose component, measure the Hct value. First, according to a command from the control unit 76, the switching circuit 71 is switched to connect the detection electrode 31, which is the working electrode for measuring the Hct value, to the current / voltage converter 72 via the terminal 53. On the other hand, the detection electrode 28, which is the opposite electrode for measuring the Hct value, is connected to the reference voltage source 78.

Then, according to the command of the control unit 76, a constant voltage (2V to 3V) is applied between the detection electrode 31 and the detection electrode 28 from the current / voltage converter 72 and the reference voltage source 78. The current flowing between the detection electrode 31 and the detection electrode 28 is converted into a voltage by the current / voltage converter 72, and the voltage value is converted into a digital value by the A / D converter 73 and output to the calculation unit 74. To. The calculation unit 74 measures the Hct value based on the digital value.

Using the measured Hct value and the amount of glucose component, a calibration curve or calibration obtained in advance Refer to the quantity line table and correct the glucose component amount with the Hct value. The corrected result may be displayed on the display unit 75 or transmitted from the transmission unit 77 to an injection device for injecting a therapeutic agent (for example, insulin). Radio waves may be used for transmission, but it is preferable to use optical communication that does not interfere with medical equipment.

If the therapeutic drug injection device can automatically set the therapeutic drug dose based on the corrected result (measurement data) transmitted from the transmitter 77, the patient does not need to set the dosage and sets it. No more hassle. Further, since the amount of insulin can be set in the injection device without using human means, it is possible to prevent a setting error.

[About negative pressure means] The blood test apparatus of the present invention may be provided with negative pressure means. It is preferable that the negative pressure means applies negative pressure to the vicinity of the punctured portion of the skin by the puncture needle 32. Therefore, the blood test device 40 having the negative pressure means preferably has a member for surrounding the vicinity of the puncture portion of the skin, and the space surrounded by the member may be negatively pressured.

FIG. 31 shows a block diagram of a blood test device 52a with negative pressure means. Since the blood test device 52a is different from the blood test device 52 shown in FIG. 29 in that it has a negative pressure means, the differences will be mainly described. The same members as the blood test device 52 are numbered the same to simplify the explanation.

In FIG. 31, the enclosure 81 extends from the end 41b of the mounting portion 41a. The control unit 76a is connected to the negative pressure means 82 (for example, a vacuum generator), and the output of the negative pressure means 82 is connected to the inside of the enclosure 81 via the negative pressure passage 83. Therefore, the negative pressure means 82 can negatively pressure the inside of the enclosure 81.

The negative pressure means 82 may be activated after step 61 in which the blood sensor 20b is brought into close contact with the measurement site and stopped after step 66 of blood collection. At the time of blood collection, the space between the skin punctured by the puncture needle and the blood sensor 20b is negatively pressured to make the skin tense and ensure blood collection quickly.

FIG. 32 shows a cross-sectional view of the blood test apparatus 52a. In FIG. 32, the enclosure 81 extends from the end 41b of the mounting portion 41a. The output of the negative pressure means 82 (for example, a vacuum generator) connected to the control unit 76a is connected to the inside of the enclosure 81 via the negative pressure passage 83. Therefore, the negative pressure means 82 can negatively pressure the inside of the enclosure 81.

FIG. 33 is an enlarged cross-sectional view of a main part in the vicinity of the enclosure 81 of the blood test apparatus 52a. In FIG. 33, when the negative pressure means 82 operates, the inside 81a of the enclosure 81 is sucked as shown by the arrow 83a, and the skin 7 is brought into close contact with the enclosure 81 and the sensor 20 to put the skin 7 in a tense state. To do. At this time, the inside 42a of the blood collection cartridge 42 is also sucked. Before puncturing with the puncture needle 32, it is preferable that the inside of the storage portion 24 is sucked from the air hole 26 in the direction of arrow 83b and negative pressure is applied to raise the skin 7. This puts the skin 7 in a tense state and facilitates puncture. After puncturing with the puncture needle 32, the inside of the reservoir 24 is sucked from the puncture hole 36 in addition to the air hole 26 as shown by arrow 83c and further negative pressure is applied to further raise the skin 7 and collect blood 13. To encourage.

Since the air hole 26 and the supply path 25 are also used as the negative pressure supply path in this way, the inside of the storage unit 24 can be negatively pressured without separately providing the negative pressure supply path. After puncturing, the puncture hole 36 can also be used as a negative pressure supply path.

FIG. 34 shows a state in which a patient is trying to perform a blood test using the blood test device 40. Blood is taken from the patient's left index finger to measure blood components (eg, blood glucose levels). In the blood test apparatus 40, there is a mounting portion 41a on one side of the housing 41. A blood collection cartridge 42 is inserted and fixed in the attachment portion 41a, and a blood sensor 20 is attached to one end of the blood collection cartridge 42. Further, a display unit 75 is provided on the other side of the housing 41. As a mechanism for driving the plunger, for example, the method disclosed in Japanese Patent Application Laid-Open No. 2006-314718 can be adopted. As a result, a double puncture prevention mechanism and a puncture depth adjustment mechanism can be realized. Further, the blood test device 40 may have a puncture depth adjusting mechanism, and as an example thereof, the puncture depth adjusting knob 84 is shown in FIG. 34.

Although the blood test apparatus of the present invention can be used for measuring glucose, it is also useful for measuring lactic acid levels and blood components of cholesterol.

Since the blood test apparatus of the present invention can easily attach and detach a blood collection cartridge including a puncture needle and a blood sensor, it can be applied to medical devices and the like.

This application claims priority based on Japanese Patent Application No. JP2006-22039 filed on January 31, 2006. All the contents described in the application specification are incorporated in the application specification.

<figref num="1">FIG. 1A is a cross-sectional view of a blood sensor in which the cover does not have a hole for the puncture needle to penetrate. FIG. 1B is a cross-sectional view of the blood sensor with a hole in the cover for the puncture needle to penetrate.</figref><figref num="2">It is sectional drawing which shows the state of introducing blood into a blood sensor.</figref><figref num="3">It is an exploded plan view of a blood sensor. FIG. 3A is a plan view of the cover. FIG. 3B is a plan view of the spacer. FIG. 3C is a plan view of the substrate.</figref><figref num="4">It is a perspective plan view of a blood sensor, and shows the arrangement of electrodes and the like. It has a reference electrode that is insulated from the connection electrode of the detection electrode. It has four pairs of connectors. The shape is octagonal.</figref><figref num="5">It is a perspective plan view of a blood sensor, and shows the arrangement of electrodes and the like. It has a connection electrode of the detection electrode and a reference electrode connected via a conductor. It has 5 connectors. The shape is octagonal.</figref><figref num="6">It is a perspective plan view of a blood sensor, and shows the arrangement of electrodes and the like. It has a counter electrode connection electrode and a reference electrode connected via a conductor. It has 5 connectors. The shape is quadrangular.</figref><figref num="7">It is a perspective plan view of a blood sensor, and shows the arrangement of electrodes and the like. It has a reference electrode connected to the connection electrode of the detection electrode with a predetermined resistance value. It has 5 connectors. The shape is octagonal.</figref><figref num="8">It is a perspective plan view of a blood sensor, and shows the arrangement of electrodes and the like. It has a counter electrode connection electrode, a reference electrode connected via a conductor, and a dummy electrode. It has 6 connectors. The shape is hexagonal.</figref><figref num="9">FIG. 9A is a perspective plan view of the blood sensor, showing the arrangement of electrodes and the like. It has a detection electrode, a working electrode, a counter electrode and a reference electrode, but no Hct electrode. It has four connectors. The shape is a regular quadrangle. On the other hand, FIG. 9B is a perspective plan view of the blood sensor, showing the arrangement of electrodes and the like. It has a detection electrode, a working electrode, a counter electrode and a reference electrode, but no Hct electrode. It has four connectors. The shape is rectangular.</figref><figref num="10">It is a perspective plan view of a blood sensor, and shows the arrangement of electrodes and the like. It has 2 reference electrodes and 6 connectors. The shape is hexagonal.</figref><figref num="11A">Indicates a blood sensor with a mounting guide.</figref><figref num="11B">The attachment part of the blood test apparatus to which the blood sensor shown in FIG. 11A is attached is shown.</figref><figref num="11C">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="11D">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="12A">Indicates a blood sensor with a mounting guide.</figref><figref num="12B">The attachment part of the blood test apparatus to which the blood sensor shown in FIG. 12A is attached is shown.</figref><figref num="12C">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="12D">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="13A">Indicates a blood sensor with a mounting guide.</figref><figref num="13B">The attachment part of the blood test apparatus to which the blood sensor shown in FIG. 13A is attached is shown.</figref><figref num="13C">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="13D">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="14A">Indicates a blood sensor with a mounting guide.</figref><figref num="14B">The attachment part of the blood test apparatus to which the blood sensor shown in FIG. 14A is attached is shown.</figref><figref num="14C">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="14D">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="15A">Indicates a blood sensor with a mounting guide.</figref><figref num="15B">The attachment part of the blood test apparatus to which the blood sensor shown in FIG. 15A is attached is shown.</figref><figref num="15C">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="15D">Indicates a state in which the blood sensor is attached to the attachment portion. The mounting guide prevents the blood sensor from being mounted in an unfavorable position.</figref><figref num="16">FIG. 16A shows a blood sensor with a mounting guide. FIG. 16B shows a mounting portion of the blood test apparatus to which the blood sensor shown in FIG. 16A is mounted. FIG. 16C shows a state in which the blood sensor is attached to the attachment portion. A mounting guide guides the blood sensor to a specific mounting position.</figref><figref num="17A">Indicates a blood sensor with a mounting guide.</figref><figref num="17B">FIG. 17A shows a mounting portion of a blood test device to which a blood sensor shown in FIG. 17A is mounted, in which connectors are arranged at non-equal angles.</figref><figref num="17C">The blood sensor shown in FIG. 17A is attached to the attachment portion shown in FIG. 17B.</figref><figref num="17D">The blood sensor shown in FIG. 17A is attached to the attachment portion shown in FIG. 17B.</figref><figref num="17E">The blood sensor shown in FIG. 17A is attached to the attachment portion shown in FIG. 17B.</figref><figref num="17F">The blood sensor shown in FIG. 17A is attached to the attachment portion shown in FIG. 17B.</figref><figref num="17G">The blood sensor shown in FIG. 17A is attached to the attachment portion shown in FIG. 17B.</figref><figref num="17H">The blood sensor shown in FIG. 17A is attached to the attachment portion shown in FIG. 17B.</figref><figref num="18A">It is a perspective view of the blood collection cartridge including a blood sensor and a holder, and the attachment part of the blood test device to which the blood collection cartridge is attached.</figref><figref num="18B">FIG. 5 is a cross-sectional view of a blood collection cartridge including a blood sensor and a holder, and a blood test device to which the blood collection cartridge is mounted.</figref><figref num="18C">FIG. 5 is a cross-sectional view of a blood collection cartridge including a blood sensor and a holder, and a blood test device to which the blood collection cartridge is mounted.</figref><figref num="18D">FIG. 5 is a cross-sectional view of a blood collection cartridge including a blood sensor and a holder, and a blood test device to which the blood collection cartridge is mounted.</figref><figref num="19A">It is a perspective view of a blood collection cartridge including a blood sensor and a holder, and a blood test device to which the blood collection cartridge is attached. The blood collection cartridge has electrodes connected to each electrode of the blood sensor through wiring.</figref><figref num="19B">It is a perspective view of a blood collection cartridge including a blood sensor and a holder, and a blood test device to which the blood collection cartridge is attached. The blood collection cartridge has electrodes connected to each electrode of the blood sensor through wiring.</figref><figref num="19C">It is sectional drawing of the blood collection cartridge which has the electrode which connects with each electrode of a blood sensor through wiring, and the attachment part of the blood test apparatus.</figref><figref num="19D">It is sectional drawing which shows the state which the blood collection cartridge which has the electrode which connects with each electrode of a blood sensor through wiring is attached to the attachment part.</figref><figref num="19E">FIG. 5 is a cross-sectional view showing a state in which a blood collection cartridge having electrodes connected to each electrode of a blood sensor through wiring is improperly attached to the attachment portion.</figref><figref num="20">It is a perspective view of the blood collection cartridge.</figref><figref num="21">It is an assembly perspective view of a blood collection cartridge.</figref><figref num="22">FIG. 22A is a cross-sectional view of the blood collection cartridge at the time of puncture. FIG. 22B is a cross-sectional view of the blood collection cartridge after the completion of puncture.</figref><figref num="23">It is a development plan view of the main part of the mounting guide for inserting a blood collection cartridge into a mounting portion.</figref><figref num="24">It is sectional drawing of the mounting part of the blood test apparatus to which the blood collection cartridge is mounted.</figref><figref num="25">FIG. 25A is a cross-sectional view showing the state of the lancet before puncture when the blood collection cartridge is attached to the blood test device. FIG. 25B is a cross-sectional view showing the state of the lancet at the time of puncture when the blood collection cartridge is attached to the blood test device. FIG. 25C is a cross-sectional view showing the state of the lancet after the completion of puncture in the state where the blood collection cartridge is attached to the blood test device.</figref><figref num="26">It is sectional drawing of the blood test apparatus which attached the blood collection cartridge.</figref><figref num="27">It is a figure which shows the flow of the blood glucose level (glucose) measurement by a blood test apparatus.</figref><figref num="28">It is a figure which shows the principle of glucose measurement in the blood of a blood test apparatus.</figref><figref num="29">It is a characteristic diagram of the blood glucose level (glucose) measurement.</figref><figref num="30">It is a block diagram of a blood test apparatus.</figref><figref num="31">It is a block diagram of the blood test apparatus which has a negative pressure apparatus.</figref><figref num="32">It is sectional drawing of the blood test apparatus which has a negative pressure apparatus.</figref><figref num="33">It is an enlarged sectional view of the main part of the blood test apparatus which has a negative pressure apparatus.</figref><figref num="34">It is a figure which shows the use state of a blood test apparatus.</figref><figref num="35">It is sectional drawing of the conventional blood sensor.</figref><figref num="36">36A and 36B are perspective views of a conventional blood sensor.</figref><figref num="37">It is a figure explaining how to use the conventional blood sensor.</figref>