Blood inspection device

The present invention relates to a blood test apparatus that tests the property of blood and the like.

Diabetes patients need to measure their blood sugar level on a regular basis and inject insulin based on this measured blood sugar level to maintain a normal blood sugar level. To maintain this normal blood sugar level, diabetes patients need to measure the blood sugar level on a regular basis, and sample a small amount of blood from their fingertips using a blood test apparatus and measure the blood sugar level from the sampled blood.

As shown in FIG. 1 , a conventional blood test apparatus is formed with: housing 2 ; cylindrical body 2 a that forms this housing 2 ; opening part 2 c that forms the front end of this cylindrical body 2 a ; laser emitting apparatus 3 that is provided in housing 2 ; blood sensor 4 (hereinafter, “sensor”) that is attached facing this laser emitting apparatus 3 ; electrical circuit section 5 that is connected to this blood sensor 4 ; and filter 6 that is provided between laser emitting apparatus 3 and blood sensor 4 and that allows laser light 3 a to pass.

The operation of blood test apparatus 1 constituted as described above will be explained below. First, sensor 4 and filter 6 that are not used yet are attached. Then, as shown in FIG. 2 , blood test apparatus 1 is abutted on skin 9 of the left hand using, for example, the right hand. Next, puncturing button 3 b shown in FIG. 1 is pressed. Then, laser emitting apparatus 3 emits laser light 3 a . Laser light 3 a passes filter 6 and sensor 4 and punctures skin 9 (see FIG. 2 ). By this puncturing, blood 10 flows out from skin 9 . This blood 10 is detected by sensor 4 . Then, electrical circuit section 5 provided in blood test apparatus 1 measures the blood sugar level. After the measurement of the blood sugar level is finished, sensor 4 is removed and discarded. Further, filter 6 is separately removed depending on how dirty filter 6 is and is discarded.

Furthermore, for example, Patent Document 1 and Patent Document 2 are known as prior art reference information related to the present invention. Patent Document 2 discloses an example of a conventional blood test apparatus of an optical reading measurement type (without a filter).

Patent Document 1: Japanese Translation of PCT Application Laid-Open No. 2004-533866 Patent Document 2: Japanese Patent Application Laid-Open No. 2001-170031

Problems to be Solved by the Invention

However, with such conventional blood test apparatuses, sensor 4 and filter 6 are attached in different locations or a filter itself is not attached. Therefore, there is a possibility that, when a filter is not attached, dust from the surrounding, blood and so on enter inside the blood test apparatus and cause a problem, or, even when a filter is attached, dust from the surrounding, blood and so on adhere to filter 6 . Further, in case of laser puncturing, dirt is likely to adhere to the vicinity of the part to puncture, because of the substance (i.e. the substance produced when skin transpires) produced by the transpiration of skin radiated by laser light. Therefore, when filter 6 is dirty, sensor 4 must be removed and, further, filter 6 attached in a different location must also be removed. That is, sensor 4 and filter 6 must be removed separately, which is troublesome, and there are many structures of blood test apparatuses from which filters cannot be removed easily and maintenance of these blood test apparatuses is not easy.

It is therefore an object of the present invention to provide a blood test apparatus that solves the above-described problem and that can easily eject a sensor unit including the blood sensor and a filter unit including the filter.

Means for Solving the Problem

To achieve this object, the blood test apparatus according to the present invention can eject the sensor unit and the filter unit separately using a single ejecting means. Consequently, it is possible to achieve the desired object.

Advantageous Effect of the Invention

The present invention can eject the sensor unit and the filter unit separately using a single ejecting means and can eject the sensor unit and the filter unit only by operating a single ejecting means. Accordingly, it is not necessary to remove the sensor unit and filter unit from separate locations, thereby making the ejection substantially easy.

Further, by replacing only the blood sensor after puncturing, it is possible to measure a plurality of other items (glucose+lactate acid and so on) in bodily fluid such as blood.

FIG. 1 is a cross-sectional view of a conventional blood test apparatus;

FIG. 2 illustrates the state of use of the conventional blood test apparatus;

FIG. 3 is a cross-sectional view of a blood test apparatus according to Embodiment 1 of the present invention;

FIG. 4 is a cross-sectional view of main parts in the blood test apparatus according to Embodiment 1 of the present invention in the first state seen from the side;

FIG. 5 is a cross-sectional view of the blood test apparatus according to Embodiment 1 of the present invention seen from above;

FIG. 6 is a cross-sectional view of main parts in the blood test apparatus according to Embodiment 1 of the present invention in the second state;

FIG. 7 is a cross-sectional view of main parts in the blood test apparatus according to Embodiment 1 of the present invention in the third state;

FIG. 8 is a developed plan view of guiding parts of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 9 is a cross-sectional view of a sensor of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 10 is a perspective plan view of the sensor of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 11 is a plan view of components constituting the sensor of the blood test apparatus according to Embodiment 1 of the present invention, (a) is a plan view of a cover of the blood test apparatus according to Embodiment 1 of the present invention, (b) is a plan view of a spacer of the blood test apparatus according to Embodiment 1 of the present invention and (c) is a plan view of a substrate of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 12 is a cross-sectional view of main parts in the sensor of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 13 is a plan view of main parts in the sensor of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 14 is a cross-sectional view of the sensor of the blood test apparatus according to Embodiment 1 of the present invention in the first state;

FIG. 15 is a cross-sectional view of the sensor of the blood test apparatus according to Embodiment 1 of the present invention in the second state;

FIG. 16 is a cross-sectional view of the sensor of the blood test apparatus according to Embodiment 1 of the present invention in the third state;

FIG. 17 is a block diagram of an electrical circuit section constituting the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 18 illustrates the operation of the blood test apparatus according to Embodiment 1 of the present invention;

FIG. 19 is a cross-sectional view of the blood test apparatus according to Embodiment 2 of the present invention;

FIG. 20 is a block diagram of the electrical circuit section constituting the blood test apparatus according to Embodiment 2 of the present invention;

FIG. 21 illustrates the operation of the blood test apparatus according to Embodiment 2 of the present invention;

FIG. 22 is a cross-sectional view of the blood test apparatus according to Embodiment 3 of the present invention;

FIG. 23 is a block diagram of the electrical circuit section constituting the blood test apparatus according to Embodiment 3 of the present invention; and

FIG. 24 illustrates the operation of the blood test apparatus according to Embodiment 3 of the present invention.

Hereinafter, embodiments of the present invention will be explained based on the accompanying drawings.

FIG. 3 is a cross-sectional view of blood test apparatus 11 according to Embodiment 1 of the present invention. In FIG. 3 , housing 12 is made of a resinic material and is provided with cylindrical body 12 b of a cylindrical shape that has opening part 12 a . Filter unit 13 including filter 21 is attached inside cylindrical body 12 b and sensor unit 14 including sensor 22 for analyzing the components of bodily fluid such as blood, is attached on the outer surface of cylindrical body 12 b.

Body part 15 a of ejecting means 15 is provided slidably on the outer surface of cylindrical body 12 b . First ejecting part 15 b and second ejecting parts 15 c are formed in body part 15 a . First ejecting part 15 b abuts on sensor unit 14 to push out and eject sensor unit 14 . Further, second ejecting parts 15 c abut on filter unit 13 to push out and eject filter unit 13 .

Next, laser emitting apparatus 16 provided in housing 12 will be explained. This laser emitting apparatus 16 is constituted by oscillating tube 16 a and cylindrical body 16 b of a cylindrical shape coupled to the front of this oscillating tube 16 a . Oscillating tube 16 a accommodates Er:YAG (yttrium aluminum garnet) laser crystal 16 c and flash light source 16 d . Partial transmission mirror 16 e of about one percent transmittance is attached to one end of oscillating tube 16 a , and total reflection mirror 16 f is attached to the other end. Convex lens 16 g is attached in cylindrical body 16 b ahead of partial transmittance mirror 16 e and is set to adjust a focus of laser light emitted from laser crystal 16 c under the skin of the patient.

Electrical circuit section 18 is connected to sensor 22 forming sensor unit 14 through connectors 53 (see FIG. 4 and this will be described later) and measures the blood sugar level from blood 10 (see FIG. 2 ) taken in sensor 22 . Vacuuming means 19 applies a negative pressure to the vicinity of sensor 22 and lifts up skin 9 upon puncturing to make it easier to sample blood. Battery 20 supplies power to electrical circuit section 18 and laser emitting apparatus 16 .

The operation of blood test apparatus 11 constituted as described above will be explained below. First, prior to test of blood 10 (see FIG. 2 ), the user (i.e. patient) inserts filter unit 13 inside cylindrical body 12 b to make locking parts 13 a lock filter unit 13 . Next, the user fits sensor unit 14 onto the outer surface of cylindrical body 12 b to make locking parts 14 a lock sensor unit 14 . At this time, connectors 53 (see FIG. 4 ) provided with opening part 12 a contact connection electrodes provided in sensor 22 to electrically connect sensor 22 and electrical circuit section 18 .

Next, the user makes blood test apparatus 11 abut on skin 9 to sample blood. Then, the user presses start button 16 j . Then, flash light source 16 d emits light, and the light source emitted from this flash light source 16 d enters Er:YAG laser crystal 16 c and the crystal is excited to generate laser light. Further, laser light is reflected between total reflection mirror 16 f , YAG laser crystal 16 c and partial transmission mirror 16 e to oscillate and amplify. Part of this amplified laser light passes partial transmission mirror 16 e by stimulated emission. Laser light 16 h that has passed this partial transmission mirror 16 e passes lens 16 g to emit and its focus is adjusted inside skin 9 . Preferably, the depth of the focus laser light punctures skin is between 0.1 millimeters and 1.5 millimeters from skin 9 , and is 0.5 millimeters with the present embodiment.

Blood 10 flows out from punctured skin 9 . Blood 10 that has flowed out is taken in sensor 22 and causes a chemical reaction in this sensor 22 . Information about blood 10 that causes the chemical reaction is transmitted to electrical circuit section 18 through the connectors and the blood sugar level and the like is measured in electrical circuit section 18 . Further, details of this will be explained later. After the blood sugar level and the like is measured, the user ejects sensor unit 14 that has been used. Further, when filter 21 is dirty, the user also ejects filter unit 13 using ejecting means 15 . How this ejection is performed will be explained next.

First, the user moves body part 15 a of ejecting means 15 toward opening part 12 a . Then, first ejecting part 15 b presses against sensor unit 14 and releases the lock in locking parts 14 a . Then, first ejecting part 15 b ejects sensor unit 14 from cylindrical body 12 b and stops.

Further, when filter 21 becomes dirty due to, for example, scattering blood 10 and skin 9 , the user further moves body part 15 a toward opening part 12 a . By so doing, second ejecting parts 15 c press against filter unit 13 and release the lock in locking parts 13 a . Then, second rejecting parts 15 c eject filter unit 13 from cylindrical body 12 b and stop.

In this way, only by operating body part 15 a , it is possible to separately eject sensor unit 14 and filter unit 13 that have been used. Consequently, sensor unit 14 and filter unit 13 are ejected substantially easily.

Further, by replacing only sensor unit 14 a plurality of times after puncturing, it is possible to measure other items (glucose+lactate acid and so on) in bodily fluid such as blood or interstitial fluid.

With the present embodiment, laser emitting apparatus 16 that can puncture skin 9 of the patient without contacting his skin, so that the operation of replacing the puncturing needle is not required compared to a contact type puncturing apparatus that uses a puncturing needle, and preparation before puncturing is simplified significantly. Further, skin 9 and laser emitting apparatus 16 do not contact, which is sanitary. Furthermore, there are no movable components unlike puncturing apparatuses that use a puncturing needle and the number of components decreases. Accordingly, an accident takes place less and it is easy to manage the components. Moreover, the structure of blood test apparatus 11 can be made water-proof, so that the apparatus can be washed entirely. Further, the puncturing voltage for this laser light 16 h is about 300 volts. Accordingly, patients suffer from little pain.

Filter unit 13 , sensor unit 14 and ejecting means 15 will be further explained in detail below. FIG. 4 is a cross-sectional view showing the vicinity of filter unit 13 and sensor unit 14 used in blood test apparatus 11 seen from the side, and FIG. 5 is a cross-sectional view showing filter unit 13 and sensor unit 14 seen from above.

In FIG. 4 and FIG. 5 , sensor unit 14 is made of a resinic material and constituted by cylindrical holder 23 that is open at both ends and sensor 22 that is attached to this holder 23 . Holder 23 is integrally formed with: cylindrical upper part 23 a ; cylindrical lower part 23 b of a smaller diameter than this upper part 23 a ; and circular, disc-shaped receiving part 23 c , which partitions between this lower part 23 b and upper part 23 a , and on which sensor 22 is arranged. The diameter of lower part 23 b is made smaller than upper part 23 a to allow a plurality of holders 23 to be stacked in layers and accommodated and adopts dimensions to allow lower part 23 b of second holder 23 to be inserted inside upper part 23 a of first holder 23 . Accordingly, it is possible to accommodate holders in small space because first holder 23 and second holder 23 are overlaid.

Further, positioning concave parts 23 f making locking parts 14 a between upper part 23 a and cylindrical body 12 b are formed in the inner surface of upper part 23 a , and hole 23 d is formed in the center of receiving part 23 c . This hole 23 d and the interior of lower part 23 b form vacuuming chamber 19 a . 23 j are skin detecting sensors provided in the bottom surface of lower part 23 b , and these skin detecting sensors 23 j are conducted with the interior of holder 23 through conductors and connected with electrodes that are formed in positioning concave parts 23 f.

These skin detecting sensors 23 j are formed with two conductive electrodes provided in different locations in the bottom surface of lower part 23 b and detect contact with skin 9 based on the change in the resistance value between conductive electrodes when these skin detecting sensors 23 j abut on skin 9 . Then, detection signals are communicated to electrical circuit section 18 through positioning concave parts 23 f . Skin detecting sensors 23 j in the present embodiment use conductive electrodes and, consequently, can be realized at low cost. Further, optical sensors, temperature sensors and the like can be used in addition to conductive electrodes for these skin detecting sensors 23 j.

Next, filter unit 13 will be explained. Filter unit 13 is formed with cylindrical holder 25 a made of resin and filter unit 21 attached on the upper surface of this holder 25 a . This filter 21 is made of material such as glass or transparent resin (ex. polypropylene) that allows laser light to pass. Accordingly, filter 21 plays a role of allowing laser light 16 h to pass and preventing, for example, the substance that has transpired and scattered from skin 9 upon puncturing, from adhering to lens 16 g.

Further, filter 21 is attached on the upper surface of holder 25 a , that is, closer to lens 16 g than to sensor 22 . Consequently, filter 21 is placed apart from the focus of laser light 16 h and is protected from the energy of laser light 16 h . Further, if filter 21 is provided apart from the focus of laser light 16 h , for example, the amount of the substance that has transpired and scattered from skin 9 and adheres to filter 21 , decreases. That is, filter 21 is prevented from being dirty, and the number of times filter 21 can be used increases, which is economical.

Circular hole 25 h is provided above holder 25 a forming filter unit 13 and circular hole 25 h is provided below holder 25 a . Laser light 16 h passes filter 21 , hole 25 g , hole 25 h and storing part 34 of sensor 22 and punctures skin 9 .

Next, how filter unit 13 and sensor unit 14 are attached to cylindrical body 12 b will be explained. In the outer surface of opening part 12 a of cylindrical body 12 b , positioning convex parts 12 f are formed in the positions to meet positioning concave parts 23 f provided in sensor unit 14 . These positioning convex parts 12 f make holder 23 fit onto the outer surface of cylindrical body 12 b and is elastic so as to fit in positioning concave parts 23 f.

In the inner surface of cylindrical body 12 b , positioning convex parts 12 g are formed in the positions to meet positioning concave parts 25 c provided in filter unit 13 . These positioning convex parts 12 g insert holder 25 a inside cylindrical body 12 b and is elastic so as to fit in positioning concave parts 25 c . Positioning concave parts 23 f and positioning convex parts 12 f make locking parts 14 , and positioning concave parts 25 c and positioning convex parts 12 g make locking parts 13 a . Consequently, when filter unit 13 is inserted inside cylindrical body 12 b , positioning concave parts 25 c and positioning convex parts 12 g fit in locking parts 13 a , and the position of filter unit 13 in cylindrical body 12 b is determined. Then, when sensor unit 14 is fitted onto the outer surface of cylindrical body 12 b , positioning concave parts 23 f and positioning convex parts 12 f fit in locking parts 14 a , thereby determining the position of sensor unit 14 in cylindrical body 12 b.

In the bottom surface of opening part 12 a , connectors 53 (including connectors 53 a to 53 f ), which will be described later, are provided, and these connectors 53 abut on connection electrodes 41 a to 45 a (described later) formed in sensor 22 when sensor unit 14 is attached to cylindrical body 12 b . Accordingly, signals from connection electrodes 41 a to 45 a are supplied to electrical circuit section 18 through these connectors 53 . Further, electrodes are also provided in the surfaces of positioning convex parts 12 f and signals from skin detecting sensors 23 j are supplied to electrical circuit section 18 .

Next, ejecting means 15 will be explained. Body part 15 a constituting ejecting means 15 is made of resin and is cylindrical. Further, body part 15 a is provided so as to slidably move on the outer surface of cylindrical body 12 b . In the lower portion of this body part 15 a , first ejecting part 15 b for pushing out the upper end of sensor unit 14 is formed. Further, cover part 15 d that covers the outer surface of holder 23 is formed continuing from this first ejecting part 15 b . The lower portion of this cover part 15 d is tapered widening downward to make it easier to insert sensor unit 14 .

From the inner surface of body part 15 a , second ejecting parts 15 c of a hook shape for pushing out filter unit 13 through holes 12 h formed in cylindrical body 12 b are provided every 90 degrees (see FIG. 5 ). Moreover, concave parts 15 e and concave parts 15 f are formed in portions of the inner surface of this body part 15 a from the bases of second ejecting parts 15 c to cover parts 15 d . When sensor unit 14 is ejected, concave parts 15 f fit in positioning convex parts 12 f and stop. When body part 15 a is further pushed out, concave parts 15 e eject filter unit 13 , and fit in positioning convex parts 12 f and stop. As shown in FIG. 5 , the negative pressure produced in vacuuming means 19 is supplied to vacuuming chamber 19 a by providing holes 25 d penetrating the top and bottom of filter 21 . With the present embodiment, four holes 25 d forming these vacuuming passages are formed. Further, body part 15 a , cylindrical body 12 b and holder 25 a may be made of transparent members such that how dirty filter 21 is can be checked from the outside.

Next, ejection of sensor unit 14 will be explained using FIG. 6 and ejection of filter unit 13 will be explained using FIG. 7 . FIG. 6 is a cross-sectional view of main parts after sensor unit 14 is ejected. Body part 15 a of ejecting means 15 is moved in the direction of arrow 24 (toward opening part 12 a ). Then, first ejecting part 15 b constituting ejecting means 15 releases the engagement between positioning concave parts 23 f and positioning convex parts 12 f to eject sensor unit 14 . Concave parts 15 f fit in positioning convex parts 12 f and stop. Consequently, when filter 21 is not dirty very much, only sensor unit 14 can be replaced.

Next, body part 15 a is further moved in the direction of arrow 24 . Then, as shown in FIG. 7 , second ejecting parts 15 c release the engagement between positioning concave parts 25 c and positioning convex parts 12 g and further move in the direction of arrow 24 , thereby ejecting filter unit 13 . Next, concave parts 15 e fit in positioning convex parts 12 f and stop. Here, in a state where sensor unit 14 is ejected or in a state where filter unit 13 is ejected, cover part 15 d provided at the front end of body part 15 a goes down, so that this cover part 15 d plays a role of protecting connectors 53 a to 53 f from dust and dirt.

Sensor unit 14 and filter unit 13 are attached in steps opposite to the above steps. That is, first, filter unit 13 is inserted inside cylindrical body 12 b . Then, positioning concave parts 25 c fit in positioning convex parts 12 g forming locking parts 13 a , thereby determining the position of filter unit 13 . Next, sensor unit 14 shown in FIG. 6 is fitted onto the outer periphery of cylindrical body 12 b . The upper end of holder 23 abuts on ejecting part 15 b and pushes body part 15 a upward. Then, positioning concave parts 23 f fit in positioning convex parts 12 f forming locking parts 14 a , thereby determining the position of sensor unit 14 .

At this time, a device is made as follows such that connection electrodes 41 a to 45 a abut on connectors 53 a to 53 f even when cylindrical sensor unit 14 is inserted carelessly. That is, guides 23 e shown in FIG. 8 are formed in the inner surface of upper part 23 a of holder 23 constituting sensor unit 14 . Further, guides 12 e are formed in the outer surface of cylindrical body 12 b onto which this sensor unit 14 is fitted. Consequently, even when cylindrical sensor unit 14 is inserted carelessly, guides 23 e are inserted along guides 12 e of cylindrical body 12 b , so that it is possible to make connection electrodes 41 a to 45 a abut on connectors 53 a to 53 f in a reliable manner. These connectors 53 a to 53 f are directly provided in opening part 12 a and need not to be moved to abut on connection electrodes 41 a to 45 a . Consequently, connectors 53 a to 53 f are electrically connected in a reliable manner and are mechanically simple, so that they produce little friction, thereby realizing electrical and mechanical reliability in connection parts.

As explained above, according to the present embodiment, it is possible to eject sensor unit 14 and filter unit 13 in two steps or eject them separately by moving body part 15 a forming ejecting means 15 . Accordingly, when filter 21 is not dirty so much, only sensor unit 14 may be ejected and, when filter 21 is very dirty, sensor unit 14 and filter unit 13 may be ejected together.

Further, these units are individual units and are easily attached and removed. Furthermore, even when one of sensor unit 14 and filter unit 13 is defective, the other good unit can be used and is not wasted.

Still further, ejecting means 15 according to the present embodiment ejects sensor unit 14 and then ejects filter unit 13 , so that, when sensor 22 is defective for example, it is possible to replace only sensor 22 easily. It is possible to measure a plurality of other items (glucose+lactate acid and so on) in bodily fluid such as blood and interstitial fluid, by replacing only sensor 22 after puncturing, so that filter unit 13 is not wasted.

Moreover, to prevent blood test apparatus 11 from being used in a irregular state, detecting sensors for detecting whether or not filter unit 13 and sensor unit 14 are attached are provided to enable puncturing only when filter unit 13 and sensor unit 14 are attached.

FIG. 9 is a cross-sectional view of sensor 22 attached to sensor unit 14 . This sensor 22 is constituted by: substrate 31 ; spacer 32 pasted on the upper surface of this substrate 31 ; and cover 33 pasted on the upper surface of spacer 32 , and has a plate shape.

Substrate hole 31 a formed in virtually the center of substrate 31 , spacer hole 32 a formed in virtually the center of spacer 32 and cover hole 33 a formed in virtually the center of cover 33 communicate to form blood storing part 34 .

This storing part 34 is open downward to abut on skin 9 and sample blood 10 . One end of supply channel 35 continues to this storing part 34 and supply channel 35 leads blood 10 stored in storing part 34 by capillary action to detecting section 37 arranged on supply channel 35 (see FIG. 10 ). Further, the other end of this supply channel 35 continues to air hole 38 .

Here, a water-repellant material is used for upper surface 33 h of cover 33 . Further, a hydrophillic material is used in supply channel 35 . Here, preferably, ceiling 34 a of storing part 34 is treated to be less hydrophilic than supply channel 35 or treated to be less water-repellant than upper surface 33 h of cover 33 .

Reagent 30 is arranged on detecting section 37 . This reagent 30 can be formed by dropping and drying reagent 30 on detection electrodes 41 and 43 (see FIG. 10 ) formed in substrate 31 .

FIG. 10 is a perspective plan view of sensor 22 . The shape of sensor 22 is a regular hexagon, and connection electrodes 41 a to 45 a that are connected with connectors 53 a to 53 f provided in opening part 12 a of blood test apparatus 11 and reference electrode 43 c that is connected with connection electrode 43 a , are formed in respective six apexes of this regular hexagon.

Storing part 34 is provided in virtually the center of sensor 22 , and supply channel 35 , one end of which is connected with this storing part 34 , is provided continuing to detection electrode 42 . Further, the other end of this supply channel 35 continues to air hole 38 . On this supply channel 35 , there are, from the side closer to storing part 34 , detection electrode 44 connected with connection electrode 44 a , detection electrode 45 connected with connection electrode 45 a , detection electrode 44 , which is provided again, connected with connection electrode 44 a , detection electrode 43 connected with connection electrode 43 a and reference electrode 43 c , detection electrode 41 connected with connection electrode 41 a , detection electrode 43 , which is provided again, connected with connection electrode 43 a and reference electrode 43 c and detection electrode 42 connected with connection electrode 42 a . Further, reagent 30 (see FIG. 9 ) is arranged on detection electrodes 41 and 43 .

FIG. 11 is an exploded plan view of sensor 22 . FIG. 11( c ) is a plan view of regular hexagonal substrate 31 constituting sensor 22 and its dimension 31 b is about 9 millimeters. The essential requirement is that the material of this substrate 31 is polyethylene terephthalate (PET) and the thickness of substrate 31 is about 0.1 millimeters.

The conductive layer is formed on the upper surface of this substrate 31 by the sputtering method or the vapor deposition method using metal material such as gold, platinum, or palladium, and detection electrodes 41 to 45 and connection electrodes 41 a to 45 a and reference electrode 43 c derived from these detection electrodes 41 to 45 are integrally formed by applying laser machining to this conductive layer. Substrate hole 31 a is provided in virtually the center of substrate 31 .

FIG. 11( b ) is a plan view of spacer 32 and its dimension 32 b is about 9 millimeters. Spacer hole 32 a is provided in virtually the center of spacer 32 in a position to meet substrate hole 31 a . This spacer 32 is a regular hexagon, and six semicircular notches 32 f are formed in the six apexes of this regular hexagon to meet connection electrodes 41 a to 45 a and reference electrode 43 c of substrate 31 .

Further, slit 32 c is formed continuing to this spacer hole 32 a and this slit 32 c forms supply channel 35 for blood 10 . The wall surfaces of this slit 32 c and the upper surface of substrate 31 to meet the wall surfaces of slit 32 c are subjected to hydrophilic treatment. The width of this slit 32 c is made about 0.6 millimeters and the length of slit 32 c is made about 2.5 millimeters to form supply channel 35 with a cavity of about 0.15 microliters. In this way, it is possible to perform test with a small amount of blood 10 , so that patients do not have to get strained and scared. The material of spacer 32 is polyethylene terephthalate and the thickness of spacer 32 is about 0.05 millimeters.

FIG. 11( a ) is a plan view of cover 33 . Its dimension 33 b is about 9 millimeters. 33 a is a cover hole provided in a position slightly decentered from the center of cover 33 . Air hole 38 is provided to meet the front end part of supply channel 35 . Diameter 38 a of this air hole 38 is about 50 micrometers. The reason for reducing the diameter of air hole 38 in this way is to prevent blood 10 from flowing out from air hole 38 . Cover 33 is a regular hexagon, and six semicircular notches 33 f are formed in the six apexes of this regular hexagon to meet connection electrodes 41 a to 45 a and reference electrode 43 c of substrate 31 . The material of this cover 33 is polyethylene terephthalate and the thickness of cover 33 is about 0.1 millimeters.

Substrate 31 , spacer 32 and cover 33 constituting sensor 22 can be formed by dividing a parent substrate of a fixed measure into several pieces. These substrate 31 , spacer 32 and cover 33 that are divided are regular hexagons and, consequently, can be aligned in the parent substrate without space. Accordingly, these materials are efficiently scribed in the parent substrate, which cuts waste, is economical and contributes to resource saving.

Further, the shape of sensor 22 may be a polygon other than a regular hexagon.

FIG. 12 is a cross-sectional view near storing part 34 of sensor 22 and FIG. 13 is a plan view of storing part 34 . In FIG. 12 and FIG. 13 , diameter 31 g of substrate hole 31 a formed in substrate 31 and diameter 32 g of spacer hole 32 a formed in spacer 32 are about 1.75 millimeters, and diameter 33 g of cover hole 33 a formed in cover 33 is 1.5 millimeters. The centers of substrate hole 31 a and spacer hole 32 a are on the same line, and the center of cover hole 33 a is in a direction slightly apart from the supply channel 35 side. Further, opposite side 34 e of supply channel 35 in substrate hole 31 a , spacer hole 32 a and cover hole 33 a are on the same plane.

According to this configuration, projecting part 33 c projecting from supply channel 35 toward the center of storing part 34 is formed in storing part 34 . The dimension of projection of this projecting part 33 c is about 0.25 millimeters and is greater 0.1 millimeters than the sum, 0.15 millimeters, of the thicknesses of substrate 31 and spacer 32 . Further, opposite side 34 e of supply channel 35 in storing part 34 is formed on the same plane. That is, there are the centers of substrate hole 31 a and spacer hole 32 a in the center of storing part 34 and the center of cover hole 33 a on the opposite side of supply channel 35 . The relationship between dimensions 31 g , 32 g and 33 g of these holes are that dimension 31 g of substrate hole 31 a and diameter 32 g of spacer hole 32 a are equal and diameter 33 g of cover hole 33 a is smaller than diameter 32 g of spacer hole 32 a.

The operation of sensor 22 constituted as described above will be explained below. As shown in FIG. 14 , when skin 9 inside storing part 34 is punctured, blood 10 flows out from punctured hole 9 a by this puncturing to form blood drop 10 a . As shown in FIG. 15 , this blood drop 10 a increasingly grows, and abuts on the tip of projecting part 33 c (shown by the dotted line). Further, before blood drop 10 a grows to reach contact point 31 j with skin 9 on the supply channel 35 side, as shown in FIG. 16 , blood drop 10 a flows into detecting section 37 through supply channel 35 at a burst in a rate-controlled state thanks to the capillary action produced by projecting part 33 c and skin 9 .

In this way, capillary action produced in the space between cover 33 and skin 9 becomes strong on the supply channel 35 side, so that it is possible to allow blood 10 to flow into detecting section 37 through supply channel 35 in a reliable manner before blood 10 fills storing part 34 . Consequently, it is possible to reduce the amount of blood left in storing part 34 . That is, the amount of blood 10 to sample decreases accordingly, so that it is possible to alleviate the burden upon patients.

FIG. 17 is a block diagram of electrical circuit section 18 . In FIG. 17 , connection electrodes 41 a to 45 a and reference electrode 43 c of sensor 22 are connected with switching circuit 60 through connectors 53 a to 53 f . The output of this switching circuit 60 is connected with the input of current/voltage converter 61 . The output of current/voltage converter 61 is connected with the input of calculating section 63 through analogue/digital converter 62 (hereinafter “A/D converter”). The output of this calculating section 63 is connected with display section 64 formed with liquid crystal and communication section 67 . Further, reference voltage source 65 is connected with switching circuit 60 . This reference voltage source 65 may be a ground potential.

Controlling section 66 controls the entire operation of the blood test apparatus according to the present invention. The output of controlling section 66 is connected with laser emitting apparatus 16 , the controlling terminal of switching circuit 60 , calculating section 63 , communication section 67 and vacuuming means 19 . Further, the input of controlling section 66 is connected with start button 16 j , skin detecting sensors 23 j and clock-and-timer 68 . It may also be possible to use a vacuum button that is manually pressed, instead of using skin detecting sensors 23 j.

Next, the operation of electrical circuit section 18 will be explained. First, to which connectors 53 a to 53 f connection electrodes 41 a to 45 a and reference electrode 43 c of sensor 22 are connected is detected. That is, according to a command from controlling section 66 , a connector having an extremely small electrical resistance between the adjacent connectors compared to other connectors is determined among connectors 53 a to 53 f . Then, when the connector having an extremely small electrical resistance compared to other connectors is determined, the connector connected with reference electrode 43 c is determined as connector 53 . It is determined based on connector 53 connected with this reference electrode 43 c that connectors 53 (i.e. starting with any of connectors 53 a to 53 f ) are connected with connection electrodes 44 a , 45 a , 41 a , 42 a and 43 a , respectively. In this way, connectors 53 a to 53 f respectively connected with connection electrodes 41 a to 45 a and reference electrode 43 c are determined and then blood 10 is measured.

In the measurement operation, switching circuit 60 is switched first to connect detection electrode 41 , which serves as an active electrode for measuring the amount of blood components, with current/voltage converter 61 . Further, detection electrode 42 , which serves as a sensing electrode for sensing the inflow of blood 10 , is connected with reference voltage source 65 . Then, a certain voltage is applied between detection electrode 41 and detection electrode 42 . In this state, when blood 10 flows in, a current flows between detection electrode 41 and detection electrode 42 . This current is converted into a voltage by current/voltage converter 61 and this voltage value is converted into a digital value in A/D converter 62 . The digital value is outputted to calculating section 63 . Calculating section 63 detects based on the digital value that sufficient blood has flowed in. At this point, the operation of vacuuming means 19 is stopped.

Next, glucose, which is a blood component, is measured. To measure the amount of glucose components, according to a command from controlling section 66 , switching circuit 60 is switched, and detection electrode 41 , which serves as an active electrode for measuring the amount of blood components, is connected with current/voltage converter 61 . Further, detection electrode 43 , which serves as a counter electrode for measuring the amount of glucose components, is connected with reference voltage source 65 .

While, for example, the glucose in blood and its oxidation-reduction enzyme are reacted for a certain period, current/voltage converter 61 and reference voltage source 65 are stopped. Further, after a certain reaction period passes, a voltage is applied between detection electrodes 41 and 43 according to the command from controlling section 66 . Then, a current flows between detection electrodes 41 and 43 . This current is converted into the voltage in current/voltage converter 61 , and the voltage value is converted into a digital value in A/D converter 62 and is outputted to calculating section 63 . Calculating section 63 converts this digital value into the amount of glucose components.

Next, after the amount of glucose components is measured, the Hct (hematocrit) value is measured. The Hct value is measured as follows. First, switch circuit 60 is switched according to a command from controlling section 66 . Then, detection electrode 45 , which serves as the active electrode for measuring the Hct value, is connected with current/voltage converter 61 . Further, detection electrode 41 , which serves as the counter electrode for measuring the Hct value, is connected with reference voltage source 65 .

Next, according to a command from controlling section 66 , a certain voltage is applied between detection electrodes 45 and 41 from current/voltage converter 61 and reference voltage source 65 . The current flowing between detection electrodes 45 and 41 is converted into the voltage in current/voltage converter 61 and the voltage value is converted into a digital value in A/D converter 62 . The digital value is outputted to calculating section 63 . Calculating section 63 converts the digital value into an Hct value.

Using the Hct value and the amount of glucose components resulting form this measurement, the amount of glucose components is corrected by the Hct value with reference to a calibration curve or calibration curve table created in advance and the correction result is displayed in display section 64 . Further, the correction result may be transmitted from communication section 67 to the injection apparatus that injects insulin. Although a radio wave may be used for this communication, transmission is preferably performed by optical communication that does not interfere with medical equipment.

By transmitting measurement data corrected in this way from communication section 67 to automatically set the dose of insulin to administer in the injection apparatus, the patient needs not to set the dose of insulin to administer, so that annoyance of setting the dose of insulin to administer is eliminated. Further, the dose of insulin can be set in the injection apparatus without an artificial means, so that it is possible to prevent setting errors.

Although measurement of glucose is explained as an example, by replacing sensor 22 , the present invention is also effective to measure the lactate acid level, cholesterol and other components in bodily fluid such as blood and interstitial fluid, in addition to glucose.

Next, the operation of blood test apparatus 11 will be explained using FIG. 18 . In step 71 , filter unit 13 is attached and then sensor unit 14 is attached to cylindrical body 12 b . Then, the flow proceeds to step 72 . In step 72 , by pressing the power supply switch of blood test apparatus 11 or by attaching sensor unit 14 to turn on the power supply switch, power is supplied from battery 20 to electrical circuit section 18 . When power is supplied to electrical circuit section 18 , reference electrode 43 c of sensor 22 is detected first. Based on detection of this reference electrode 43 c , detection electrodes 41 to 45 are specified.

Then, in step 73 , the patient waits while blood test apparatus 11 is abutted on skin 9 to puncture. When skin detecting sensors 23 j of sensor unit 14 detect contact of skin 9 , the flow proceeds to step 74 and vacuuming means 56 is operated. Then, this vacuuming means 19 applies a negative pressure to vacuuming chamber 19 a (the vicinity of sensor 22 ). A vacuum button (not shown) may be connected with controlling section 66 and be pressed instead of using skin detecting sensors 23 j.

When the current in the vacuum pump forming vacuuming means 19 changes or the time determined in advance in clock-and-timer 68 passes, it is decided that skin 9 inside storing part 34 is sufficiently lifted up, and the flow proceeds to step 75 . In step 75 , display section 64 displays that puncturing is possible. In next step 76 , according to this display, patients press start button 16 j constituting laser emitting apparatus 16 .

When start button 16 j is pressed, laser light 16 h passes filter 21 attached to filter unit 13 and punctures skin 9 . Blood 10 flows out as a result of puncturing skin 9 . This blood 10 is taken in detecting section 37 of sensor 22 . Then, in step 78 , the blood sugar level of blood 10 is measured.

After the blood sugar level is measured in step 78 , the flow proceeds to step 79 and the vacuuming by vacuuming means 19 is stopped. Then, the flow proceeds to step 80 and the blood sugar level that is measured is displayed in display section 64 . Further, the display in step 75 to the effect that puncturing is possible, is turned off in step 77 . That is, display is turned off at the timing blood 10 reaches detection electrode 42 before the blood sugar level is measured in step 78 . Further, the vacuuming may be stopped at this timing.

FIG. 19 is a cross-sectional view of blood test apparatus 11 - 2 according to Embodiment 2 of the present invention. To simplify explanation, the same components as in above-described Embodiment 1 will be assigned the same reference numerals.

In FIG. 19 , housing 12 is made of a resinic material and is provided with a cylindrical body of a cylindrical shape that has opening part 12 a . Filter unit 13 in which filter 21 is attached is attached inside cylindrical body 12 b , and sensor unit 14 in which sensor 22 is attached is attached on the outer surface of cylindrical body 12 b.

Body part 15 a of ejecting means 15 is provided slidably on the outer surface of cylindrical body 12 b . First ejecting part 15 b and second ejecting parts 15 c are formed in body part 15 a . First ejecting part 15 b abuts on sensor unit 14 to push out and eject sensor unit 14 . Second ejecting parts 15 c abut on filter unit 13 to push out and eject filter unit 13 .

Next, optical reading section 90 provided in housing 12 will be explained. This optical reading section 90 radiates light on sensor 22 to detect the state of sensor 22 after drops of blood are spotted on sensor 22 and outputs a detection signal according to the amount of received reflected light. Further, electrical circuit section 18 - 2 is electrically connected with optical reading section 90 that detects the state of sensor 22 and optically reads blood 10 (see FIG. 2 ) taken in sensor 22 to measure the blood sugar level based on this detection signal. Battery 20 supplies power to electrical circuit section 18 - 2 and optical reading section 90 .

Here, the measurement scheme according to Embodiment 2 is a scheme whereby a custom-designed reagent is added to a sensor such that the sensor shows a unique color matching the blood component to measure and the grade of color showing the specific blood component is optically measured. The same applies to Embodiment 3 described later.

FIG. 20 is a block diagram of electrical circuit section 18 - 2 according to Embodiment 2.

In FIG. 20 , as a detecting mechanism for detecting the state of sensor 22 after drops of blood are spotted on sensor 22 , optical reading section 90 has light emitting element 90 a which radiates light on sensor 22 and light receiving element 90 b which receives the light emitted by light emitting element 90 a and reflected by sensor 22 . Light receiving element 90 b outputs an analogue signal matching the amount of received light. This analogue signal is amplified by amplifying section 91 . The output of amplifying section 91 is connected to the input of calculating section 63 through A/D converter 62 . The output of this calculating section 63 is connected with display section 64 made of liquid crystal and communication section 67 .

Controlling section 66 controls the entire operation of the blood test apparatus according to the present invention. The output of controlling section 66 is connected to optical reading section 90 , calculating section 63 and communication section 67 . Further, the input of controlling section 66 is connected to start button 16 j , skin detecting sensors 23 j and clock-and-timer 68 .

Next, the operation of electrical circuit section 18 - 2 will be explained.

In a state where drops of blood are spotted on sensor 22 attached in sensor unit 14 , in optical reading section 90 , light from light emitting element 90 a of optical reading section 90 passes filter unit 13 in which filter 21 is attached, is radiated on sensor 22 on which drops of blood are spotted, is reflected by sensor 22 and is received by light receiving element 90 b of optical reading section 90 . As a result, an analogue signal matching the amount of received light is outputted. The analogue signal outputted is amplified in amplifying section 91 and then is converted into a digital value in A/D converter 62 . Then, the digital value is outputted to calculating section 63 . Calculating section 63 performs internal arithmetic operation processing based on this digital value and display section 64 displays the measurement result of blood test. Further, the measurement result is transmitted from communication section 67 to the injection apparatus that injects insulin. Although a radio wave may be used for this communication, transmission is preferably performed by optical communication that does not interfere with medical equipment.

Next, the operation of blood test apparatus 11 - 2 according to Embodiment 2 will be explained using FIG. 21 . In step 101 , filter unit 13 is attached and then sensor unit 14 is attached to cylindrical body 12 b . Then, the flow proceeds to step 102 . In step 102 , by pressing the power supply switch of blood test apparatus 11 - 2 or by attaching sensor unit 14 to automatically turn on the power supply switch, power is supplied from battery 20 to electrical circuit section 18 - 2 . After power is supplied to electrical circuit section 18 - 2 , preparation for measurement such as initial processing is performed. When the preparation for measurement is finished, display section 64 displays that measurement is possible and stand-by is finished. Next, in step 103 , when puncturing skin by means of a separate puncturing apparatus (which is not included in Embodiment 2), the patient waits while sensor 22 attached in sensor unit 14 is abutted on the finger and drops of blood 10 are spotted on sensor 22 .

When skin detecting sensors 23 j detect contact of the finger, the flow proceeds to step 104 and display is turned off.

At this time, it may also be possible to launch a start of measurement by the method of pressing start button 16 j instead of using skin detecting sensors 23 j.

Next, the flow proceeds to step 105 and the blood sugar level of blood 10 is measured through the optical reading section. After the blood sugar level is measured in step 105 , the flow proceeds to step 106 and the measured blood sugar level is displayed in display section 64 .

FIG. 22 is a cross-sectional view of blood test apparatus 11 - 3 according to Embodiment 3 of the present invention. To simplify explanation, the same components as in above-described Embodiment 1 and Embodiment 2 will be assigned the same reference numerals.

In FIG. 22 , housing 12 is made of a resinic material and is provided with cylindrical body 12 b of a cylindrical shape that has opening part 12 a . Filter unit 13 in which filter 21 is attached is attached inside cylindrical body 12 b , and sensor unit 14 in which sensor 22 is attached is attached on the outer surface of cylindrical body 12 b.

Body part 15 a of ejecting means 15 is provided slidably on the outer surface of cylindrical body 12 b . First ejecting part 15 b and second ejecting parts 15 c are formed in body part 15 a . First ejecting part 15 b abuts on sensor unit 14 to push out and eject sensor unit 14 . Second ejecting parts 15 c abut on filter unit 13 to push out and eject filter unit 13 .

With Embodiment 3, laser emitting apparatus 16 and optical reading section 90 (components 90 a and 90 b are shown) are provided in housing 12 . Laser emitting apparatus 16 is basically the same as the laser emitting apparatus used in above-described Embodiment 1. Further, optical reading section 90 is basically the same as the optical reading section used in above-described Embodiment 2. The function will not be explained.

FIG. 23 is a block diagram of electrical circuit section 18 - 3 of blood test apparatus 11 - 3 according to Embodiment 3.

In FIG. 23 , as a detecting mechanism for detecting the state of sensor 22 after drops of blood are spotted on sensor 22 , optical reading section 90 has light emitting element 90 a which radiates light on sensor 22 and light receiving element 90 b which receives the light emitted by light emitting element 90 a and reflected by sensor 22 . Light receiving element 90 b outputs an analogue signal matching the amount of received light. This analogue signal is amplified by amplifying section 91 , and then the output of amplifying section 91 is connected to the input of calculating section 63 through analogue/digital converter 62 (hereinafter “A/D converter”). The output of this calculating section 63 is connected with display section 64 made of liquid crystal and communication section 67 .

Controlling section 66 controls the entire operation of the blood test apparatus according to the present invention. The output of controlling section 66 is connected to laser emitting apparatus 16 , light emitting element 90 a which is a component in optical reading section 90 , calculating section 63 , communication section 67 and vacuuming means 19 . Further, the input of controlling section 66 is connected to start button 16 j , skin detecting sensors 23 j and clock-and-timer 68 . Furthermore, it may also be possible to use a vacuum button (not shown) that is manually pressed, instead of using skin detecting sensors 23 j.

Next, the operation of electrical circuit section 18 - 3 will be explained. With the measurement operation, in a state where drops of blood are spotted on sensor 22 attached in sensor unit 14 , light from light emitting element 90 a of optical reading section 90 passes filter unit 13 , is radiated on sensor 22 on which drops of blood are spotted, is reflected by sensor 22 and then is received by light receiving element 90 b of optical reading section 90 . An analogue signal matching the amount of received light is outputted. The analogue signal outputted is amplified in amplifying section 91 and then is converted into a digital value in A/D converter 62 . Then, the digital value is outputted to calculating section 63 . Calculating section 63 performs internal arithmetic operation processing based on this digital value and display section 64 displays the measurement result of blood test. Further, the measurement result is transmitted from communication section 67 to the injection apparatus that injects insulin. Although a radio wave may be used for this communication, transmission is preferably performed by optical communication that does not interfere with medical equipment.

Next, the operation of blood test apparatus 11 - 3 according to Embodiment 2 will be explained using FIG. 24 . In step 111 , filter unit 13 is attached and then sensor unit 14 is attached to cylindrical body 12 b . By pressing the power supply switch of blood test apparatus 11 - 3 or by attaching sensor unit 14 to turn on the power supply switch, power is supplied from battery 20 to electrical circuit section 18 - 3 . After power is supplied to electrical circuit section 18 - 3 , preparation for measurement such as initial processing is performed.

Then, in step 112 , the patient waits while blood test apparatus 11 - 3 is abutted on skin 9 to sample blood. When skin detecting sensors 23 j of sensor unit 14 detect skin 9 , the flow proceeds to step 113 and vacuuming means 19 is operated. Then, this vacuuming means 19 applies a negative pressure to vacuuming chamber 19 a (near sensor 22 ). Further, it may also be possible to connect a vacuum button (not shown) to controlling section 66 and press this vacuum button, instead of using skin detecting sensors 23 j.

When the current in the vacuum pump forming vacuuming means 19 changes or the time determined in advance in clock-and-timer 68 passes, it is decided that skin 9 inside storing part 34 is sufficiently lifted up and the flow proceeds to step 114 . In step 114 , display section 64 displays that puncturing is possible. In next step 115 , according to this display, the patient presses start button 16 j constituting laser emitting apparatus 16 .

By pressing start button 16 j , laser light 16 h passes filter 21 attached to filter unit 13 and punctures skin 9 . Blood 10 flows out as a result of puncturing skin 9 . This blood 10 is taken in detecting section 37 of sensor 22 . Then, in step 117 , the blood sugar level of blood 10 is measured.

After the blood sugar level is measured in step 117 , the flow proceeds to step 118 and the vacuuming by vacuuming means 19 is stopped. Then, the flow proceeds to step 119 and the blood sugar level that is measured is displayed in display section 64 .

Further, the display in step 114 to the effect that puncturing is possible, is turned off in step 116 . That is, the display is turned off at the timing blood 10 reaches detection electrode 42 before the blood sugar level is measured in step 78 . Further, the vacuuming may be stopped at this timing.

The disclosure of Japanese Patent Application No. 2007-007755, filed on Jan. 17, 2007, including the specification, drawings and abstract, is incorporated herein by reference in its entirety.

The blood test apparatus according to the present invention can eject the blood sensor and filter together or separately using a single ejecting means and, consequently, is applicable to blood test apparatuses of an optical measurement type or blood test apparatuses having a puncturing means.