JP5262551B2 - Blood test equipment - Google Patents

Description

  The present invention relates to a blood test apparatus for testing blood sugar levels and the like.

  Hereinafter, a conventional blood test apparatus will be described. FIG. 21 is a perspective view of a conventional blood test apparatus 1, and FIGS. 22 to 25 are plan views of the blood test apparatus 1 in use.

  In FIG. 21, reference numeral 2 denotes a main body case having a substantially rectangular parallelepiped shape, and a puncture portion 3 for puncturing the skin is provided on one longitudinal side surface of the main body case 2. The puncture portion 3 is provided with a semicircular finger cover 4, and a finger insertion hole 5 covered with the finger cover 4 is formed. Further, a puncture button 6 a is provided on the other longitudinal side surface of the main body case 2, and a display unit 7 is provided on the upper surface side of the main body case 2.

  The puncture unit 3 is equipped with a blood sensor (hereinafter referred to as a sensor), and this sensor is connected to an electric circuit unit for measuring a blood sugar level or the like. The blood glucose level measured by this electric circuit unit is displayed on the display unit 7. A laser puncture unit 6 (not shown) is mounted inside the main body case 2 so as to face the puncture unit 3, and this laser puncture unit 6 is activated when the puncture button 6a is pressed.

  The operation of blood test apparatus 1 configured as described above will be described below. This blood test apparatus 1 is a portable type that can be easily grasped, and inserts a finger 8 (a general term for a finger) into the finger insertion hole 5 and presses the puncture button 6a. When the puncture button 6a is pressed, a laser beam 6b (not shown) is emitted from the laser puncture unit 6, and the finger 8 is punctured. Blood 10 (not shown) exudes from the finger 8. The exuded blood 10 is taken into the sensor. The blood 10 taken into the sensor reacts with the reagent in the sensor. The reaction result is transmitted to the electric circuit unit, and the blood glucose level and the like are measured by the electric circuit unit. Then, the measured value is displayed on the display unit 7.

  Hereinafter, the usage state of the blood test apparatus 1 will be described. FIG. 22 is a plan view when blood 10 is collected from the index finger 8b of the right hand. The main body case 2 is gripped with the right hand, and the index finger 8 b is inserted into the finger insertion hole 5. Then, the puncture button 6a is pressed with the thumb 8a. As a result, the blood glucose level of the blood 10 that is pierced by the index finger 8b and exudes from the skin surface can be measured.

  FIG. 23 is a plan view when blood 10 is collected from the middle finger 8c of the right hand. The main body case 2 is gripped with the right hand, and the middle finger 8 c is inserted into the finger insertion hole 5. Then, the puncture button 6a is pressed with the thumb 8a. As a result, the blood sugar level of the blood 10 pierced by the middle finger 8c and exuded from the skin surface can be measured.

  FIG. 24 is a plan view when blood 10 is collected from the ring finger 8d of the right hand. The main body case 2 is grasped with the right hand, and the ring finger 8 d is inserted into the finger insertion hole 5. Then, the puncture button 6a is pressed with the thumb 8a. Thus, the blood sugar level of blood 10 pierced by ring finger 8d and exuded from the skin surface can be measured.

  FIG. 25 is a plan view when blood 10 is collected from the little finger 8e of the right hand. The main body case 2 is gripped with the right hand, and the little finger 8 e is inserted into the finger insertion hole 5. Then, the puncture button 6a is pressed with the thumb 8a. As a result, the blood sugar level of blood 10 pierced by the little finger 8e and exuded from the skin surface can be measured.

As prior art document information related to the invention of this application, for example, Patent Document 1 is known.
JP-A-10-24028

  However, in such a conventional blood test apparatus 1, the grasping position differs depending on the type of the finger 8 to be punctured (the index finger 8b, the middle finger 8c, the ring finger 8d, and the little finger 8e). The inspection apparatus 1 has a problem that it is difficult to grasp and has poor operability.

  The present invention has been made to solve such problems, and an object of the present invention is to provide a blood test apparatus having a compact shape and good operability.

  In order to achieve this object, a blood test apparatus according to the present invention includes a main body case having a puncture portion, a puncture means provided in the main body case and opposed to the puncture portion, and the puncture portion. A blood sensor to be mounted; and an electric circuit portion electrically connected to the blood sensor; a cover case that covers at least a portion of the main body case and is slidable; and the cover case is pulled out In the above, the cover case is provided with a finger insertion hole at a position corresponding to the puncture portion. Thereby, the intended purpose can be achieved.

  As described above, the blood test apparatus of the present invention is provided with a cover case that covers at least a part of the main body case and is slidable. In the state where the cover case is pulled out, the cover case has a position corresponding to the puncture portion. Since the finger case is provided with a finger insertion hole and a cover case is provided to make the outer shape of the main body case substantially extendable and retractable, the blood test apparatus is substantially enlarged by pulling out the cover case. Can be gripped easily. Moreover, in the state which accommodated the main body case in the cover case, it becomes a compact shape convenient for carrying.

  Further, when puncturing, even if a puncturing means such as one that punctures with laser light is used, it is safe because the cover case is located at a position that prevents the laser light from being emitted outside the finger insertion hole. is there. Furthermore, in the state stored in the cover case, the finger insertion hole is closed by the main body case 2 and does not correspond to the puncture portion, so that it is not possible to insert a finger and it is safe.

(Embodiment 1)
Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is an exploded perspective view of a blood test apparatus 11 of the present invention. The blood test apparatus 11 includes a main body case 12 and a cover case 13 that covers the main body case 12.

  The main body case 12 has a substantially rectangular parallelepiped shape, and a puncture portion 14 is provided at a lower corner. The cover case 13 has a box shape with at least an upper part 13a opened, and is inserted from below the main body case 12 to cover the puncture part 14. The cover case 13 is slidably inserted into the main body case 12. A first state in which the main body case 12 is stored in the cover case 13 and a second state in which the cover case 13 is pulled out from the main body case 12 are formed.

  The cover case 13 is provided with a semi-circular finger insertion hole 15 penetrating from the front surface 13b to the back surface 13c. The finger insertion hole 15 corresponds to the puncture portion 14 in the second state in which the cover case 13 is pulled out. It is provided so that it may become a position to do. Therefore, in this second state, when the finger 8 is inserted into the finger insertion hole 15, the finger 8 is restricted so as to contact the puncture portion 14. Further, one side surface 13d of the cover case 13 protrudes upward, and a recess 13e is formed on the inside thereof. The recess 13e covers the puncture button 19 (see FIG. 3) when the cover case 13 is in the first state.

  On the front surface 12a of the main body case 12, an operation switch 16 and a display unit 17 formed of liquid crystal are provided. A discharge slider 18 for discharging a blood sensor 23 (hereinafter referred to as “sensor”, see FIGS. 7 to 9) is slidably provided on the other side surface 12 b of the main body case 12.

FIG. 2 is an external perspective view of the blood test apparatus 11 in the first state in which the main body case 12 is inserted into the cover case 13. In this state, since the main body case 12 is inserted into the cover case 13, the blood test apparatus 11 has a compact size convenient for carrying. In addition, since the puncture button 19 (see FIG. 3) is covered with the one side surface 13d of the cover case 13, it is safe to never press the puncture button 19 by mistake. Furthermore, since the puncture part 14 is covered with the surface 13b of the cover case 13, the finger 8 cannot be inserted from the finger insertion hole 15 and is safe.
Further, there is a method of controlling the power on / off in conjunction with the sliding operation of the cover case 13.

  In the first state in which the cover case 13 is inserted into the main body case 12, the power is turned off. As a result, the blood test apparatus 11 cannot operate, so it is safe even while being carried.

  FIG. 3 is an overall perspective view in the second state in which the cover case 13 is pulled out from the main body case 12. In this state, the cover case 13 is pulled out from the main body case 12, and the finger insertion hole 15 provided in the cover case 13 is in a position corresponding to the puncture portion 14 provided in the main body case 12 (see FIG. 5). Therefore, any finger 8 can be easily inserted into the finger insertion hole 15 and punctured. Moreover, as the blood test apparatus 11, since the cover case 13 is pulled out, the whole apparatus becomes long and it becomes easy to grasp. As a result, even if any finger 8 (index finger 8b, middle finger 8c, ring finger 8d, little finger 8e) is inserted into the finger insertion portion, it can be gripped without impairing operability as in the prior art.

  Further, by moving one side surface 13d of the cover case 13 downward, the puncture button 19 is exposed, and the puncture button 19 can be easily operated.

  Further, when a function for controlling on / off of the power supply in conjunction with the sliding operation of the cover case 13 is installed, the power is turned on in the second state in which the cover case 13 is pulled out. To. Thereby, since it is confirmed that the blood test apparatus 11 can automatically prepare for operation and is surely in the second state, the reliability is improved together with the operability.

  FIG. 4 is a perspective view of the first state in which the main body case 12 is inserted into the cover case 13 as viewed from the back side. In this state, the main body case 12 is inserted into the cover case 13, and the blood sensor discharge slider 18 provided on the other side surface 12 b of the main body case 12 is locked on the opening 13 j side of the cover case 13. It is regulated by. Therefore, in this state, the slide of the discharge slider 18 is suppressed, and the blood sensor 23 that is mounted by mistake is not discharged.

  FIG. 5 is a perspective view of the second state in which the cover case 13 is pulled out from the main body case 12 as seen from the back side. In this state, the cover case 13 is pulled out from the main body case 12, and the finger insertion hole 15 is in a position corresponding to the puncture portion 14, and the finger 8 can be inserted into the finger insertion hole 15 for puncture. . Further, the discharge slider 18 provided on the other side surface 12b of the main body case 12 can be slid. Accordingly, by sliding the discharge slider 18 downward in this state, the used sensor 23 can be discharged after the puncturing / measurement is completed.

  Reference numeral 65 denotes a discharge button of the sensor cartridge 24 (see FIG. 6). By pressing the discharge button 65, the sensor cartridge 24 is discharged from the surface 12a. The discharge button 65 is provided in a recess that is one step lower than the surface of the main body case 12 so as not to be pressed by mistake.

  The cover case 13 is shaped so as to cover the discharge button 65 in the same manner as the shape covering the puncture button described above, so that whether or not the discharge button 65 can be used is controlled by the sliding operation of the cover case 13. it can. That is, when the cover case 13 is pulled out, the cover of the discharge button 65 is released, and when the main body case 12 is stored in the cover case 13, the cover is covered with the discharge button 65 and use is prohibited. It is possible to do so. Thus, the discharge button is prohibited from operating when it is not necessary, and erroneous operation can be prevented.

  Next, reference numeral 66 denotes a level setting dial. When the puncturing means is a needle puncturing method, the level setting dial 66 sets / adjusts the puncture depth level. When the puncturing means is a laser puncturing method, the output level of the laser from the high voltage generating circuit 30h (see FIG. 16) is adjusted by the set level output of the level setting dial 66. The level setting dial 66 is provided in a recess that is one step lower than the surface of the main body case 12 so as not to be operated by mistake.

  Next, 67 is an auxiliary display portion provided on the upper surface of the main body case 12, and is formed of a light emitting diode. The auxiliary display unit 67 visually informs the patient of the puncture timing when counting down during puncture, and visually notifies the patient of a display such as measurement completion or measurement completion using a plurality of colors. It is something to do. During puncturing and measurement operations, the patient is expected to have the entire device, and it is difficult to see the display provided on the front of the body. Therefore, during operation, the guide display of the auxiliary display unit arranged on the upper surface is effective. The flow is such that the completion of measurement is confirmed by the display of the light emitting diode on the auxiliary display section, and then the measurement result is confirmed on the display section in front of the main body.

  FIG. 6 is a cross-sectional view of the main body 21 constituting the blood test apparatus 11. A puncture portion 14 is provided at a lower corner of the main body case 12 constituting the main body portion 21. This puncture part 14 is comprised by the upper holder 14a and the lower holder 14b. The sensor 23 is sandwiched and fixed between the upper holder 14a and the lower holder 14b.

  A laser puncture unit 22 (used as an example of puncture means) that emits laser light is attached to face the puncture unit 14. In the present embodiment, the laser puncture unit 22 is used. However, this is not limited to the laser puncture unit 22, and a needle puncture unit using a puncture needle may be used.

  In parallel with the laser puncture unit 22, a sensor cartridge 24 in which a sensor 23 is stacked and accommodated is detachably inserted. The sensor cartridge 24 includes a sensor chamber 24a in which the sensor 23 is accommodated and a desiccant chamber 24b in which the desiccant 25 is accommodated. The stacked sensor 23 is pressed downward (to the left in the drawing) by a spring 24c. A slide plate 27 is attached to the lower end (left end in the drawing) of the sensor cartridge 24. By sliding a power transmission portion 27a formed on the slide plate 27, the slide plate 27 is moved to the bottom (left in the drawing) side. The stacked sensor 23 is pushed out and conveyed between the upper holder 14a and the lower holder 14b.

  Reference numeral 28 denotes a conveying means that conveys the sensor 23 to the puncture unit 14 by moving the slide plate 27 in the left and right (up and down in the drawing) direction. For example, the conveying means 28 slidably fits the power transmission unit 27a into a spiral groove formed on the surface of a cylinder 28a (not shown), and rotates the cylinder 28a to move the slide plate 27 left and right. Slide in the direction.

  The cylinder 28a is driven by a motor. The activation of the motor is detected and activated by a slide sensor 12d (see FIG. 16) that detects that the cover case 13 has been pulled out. Accordingly, when the cover case 13 is pulled out, the sensor 23 is automatically set on the puncture portion 14.

  A negative pressure means 29 is accommodated adjacent to the conveying means 28. This negative pressure means 29 raises the skin 9 (see FIG. 15) by making the inside of the puncture part 14 negative pressure during puncture via a negative pressure path. An electric circuit portion 30 is accommodated adjacent to the negative pressure means 29 and the sensor cartridge 24. The electric circuit unit 30 performs measurement of blood glucose level, control of the laser puncture unit 22, control of the negative pressure means 29, and control of the transport means 28 based on the signal from the sensor 23.

  A battery 20 supplies power to these elements, and is inserted adjacent to the electric circuit section 30 and the negative pressure means 29 so as to be freely inserted and removed.

  Hereinafter, each element will be described in detail. FIG. 7 is a cross-sectional view of the sensor 23. The sensor 23 includes a substrate 31, a spacer 32 bonded to the upper surface of the substrate 31, and a cover 33 bonded to the upper surface of the spacer 32.

  Reference numeral 34 denotes a reservoir for blood 10 (see FIG. 15). The reservoir 34 is formed in the spacer 32 corresponding to the substrate hole 31a formed in the approximate center of the substrate 31 and the substrate hole 31a. A spacer hole 32a and a cover hole 33a formed in the cover 33 corresponding to the substrate hole 31a are formed in communication. Reference numeral 36 denotes a positioning hole that determines the mounting position of the sensor 23 on the puncture portion 14 and is formed through the sensor 23.

  Reference numeral 35 denotes a supply path for blood 10 having one end connected to the storage section 34, and an introduction path for guiding the blood 10 stored in the storage section 34 to the detection section 37 by capillary action. The other end of the supply path 35 is connected to the air hole 38. The volume of the reservoir 34 is about 1 μL, and the volume of the supply path 35 is 0.1 to 0.2 μL. In this way, it is possible to test with a small amount of blood 10, thereby reducing the burden on the patient.

  Reference numeral 40 denotes a reagent placed on the detection unit 37. This reagent 40 is a 0.01 to 2.0 wt% CMC aqueous solution, PQQ-GDH 0.1 to 5.0 U / sensor, potassium ferricyanide 10 to 200 mM, maltitol 1 to 50 mM, and taurine 20 to 200 mM. The reagent solution is prepared by adding and melting the solution, and the reagent solution is dropped on the detection electrodes 41 and 43 (see FIG. 8) formed on the substrate 31 and dried. When the reagent 40 absorbs moisture, the performance of the reagent 40 progresses with a slight deterioration. In order to prevent this deterioration as much as possible, a desiccant 25 is accommodated in the sensor cartridge 24.

  Here, a conductive layer is formed on the upper surface of the substrate 31 by a sputtering method or a vapor deposition method using gold, platinum, palladium or the like as a material, and this is detected by laser processing with detection electrodes 41 to 45 (see FIG. 8) and this detection. Connection electrodes 41a to 45a and identification electrodes 47a respectively led out from the electrodes 41 to 45 are integrally formed.

The substrate 31, spacer 32, and cover 33 are all made of polyethylene terephthalate (PET). Management costs are reduced by sharing materials.
FIG. 8 is a perspective plan view of the sensor 23, and connection electrodes 41a to 45a and an identification electrode 47a are formed at one end. An identification portion 47 formed of a conductor pattern is formed between the connection electrode 43a and the identification electrode 47a.

  The storage part 34 is provided in the approximate center of the sensor 23, and a supply path 35 having one end connected to the storage part 34 is provided toward the detection electrode 42. The other end of the supply path 35 is connected to the air hole 38. On the supply path 35, the detection electrode 44 sequentially connected to the connection electrode 44a from the reservoir 34, the detection electrode 45 connected to the connection electrode 45a, the detection electrode 44 connected to the connection electrode 44a again, A detection electrode 43 connected to the connection electrode 43a, a detection electrode 41 connected to the connection electrode 41a, a detection electrode 43 connected again to the connection electrode 43a, and a detection electrode 42 connected to the connection electrode 42a are provided. ing. A reagent 40 (see FIG. 7) is placed on the detection electrodes 41 and 43.

  Whether or not the sensor 23 is attached to the puncture unit 14 can be identified based on whether or not there is electrical continuity between the connection electrode 43a and the identification electrode 47a. That is, when the sensor 23 is conveyed to the puncture unit 14, it is detected whether or not the sensor 23 is securely attached to the puncture unit 14 by detecting electrical continuity between the connection electrode 43a and the identification electrode 47a. be able to. If there is no electrical continuity, the sensor 23 is not attached to the puncture unit 14. In this case, a warning can be displayed on the display unit 17 (see FIG. 16) of the blood test apparatus 11.

  In addition, by changing the electric resistance value of the identification unit 47, it is possible to store information on a calibration curve to be used or store manufacturing information. Therefore, a more precise blood test can be performed using these pieces of information.

  FIG. 9 is a perspective view of the sensor 23. The sensor 23 is formed of a rectangular plate. A storage section 34 is formed in the approximate center of the plate body, and connection electrodes 41a to 45a and an identification electrode 47a are formed at one end. A positioning hole 36 is formed in the vicinity of the other end. The positioning hole 36 has a trapezoidal shape in which the storage portion 34 side is narrowed. An air hole 38 is formed between the positioning hole 36 and the storage portion 34.

  This is to minimize the possibility that the blood 10 or the like that has adhered will reattach to the spring 14c side. The spring 14c is opened from the hole 14g side toward the connector 49 side. Therefore, the sensor 23 conveyed to the puncture unit 14 is smoothly inserted. Reference numeral 14 j denotes a positioning convex portion that fits into the positioning hole 36 formed in the sensor 23.

  FIG. 11 is a perspective view of the lower holder 14b forming the puncture portion 14 as viewed from the upper surface side (right side in FIG. 6). A spring 14d is provided on this upper surface. This spring 14d is integrally formed of the same material as the resin forming the lower holder 14b. Two springs 14d are provided at positions facing the spring 14c formed on the upper holder 14a, and support the sensor 23 at one point. In this way, the contact area with the sensor 23 is reduced. This is to minimize the possibility that the blood 10 or the like attached to the sensor 23 will reattach to the spring 14d side. The spring 14d is also gradually inclined and opened from the side of the hole 14m penetrating the lower holder 14b. Therefore, the sensor 23 conveyed to the puncture unit 14 is smoothly inserted. Reference numeral 14p denotes a tongue piece that is pushed up by the pressing portion 18c forming the pressing slider 18 (see FIGS. 1 and 13).

  FIG. 12 is a cross-sectional view of the puncture unit 14 when the sensor 23 is discharged. FIG. 12A is a cross-sectional view showing a state in which the sensor 23 is sandwiched and fixed between the upper holder 14a and the lower holder 14b. Reference numeral 14f denotes a leaf spring that presses the lower holder 14b toward the upper holder 14a. The lower holder 14b is held parallel to the upper holder 14a by the leaf spring 14f. At this time, the springs 14c and 14d are bent against elasticity. The springs 14 c and 14 d are deformed and do not affect the airtightness between the upper and lower holders 14 a and 14 b and the sensor 23. In this state, the negative pressure means creates a negative pressure around the storage portion 34 of the sensor 23, swells the skin, punctures by the laser puncture unit 22, and then is spotted and measured and examined.

  FIG. 12B is a cross-sectional view showing a state where the puncturing operation by the laser puncturing unit 22 is completed and the measurement / inspection is completed. When the discharge slider 18 (see FIG. 5) is slid downward after the series of measurement operations is completed, the pressing portion 18c connected to the discharge slider 18 pushes up the tongue piece 14p of the lower holder 14b. When the tongue piece 14p is pushed up, the lower holder 14b is separated from the upper holder 14a. At this time, it goes away first from the side opposite to the tongue piece 14p. Thus, when the space between the upper holder 14a and the lower holder 14b is opened, the sensor 23 forms gaps 14q and 14r between the upper holder 14a and the lower holder 14b by the elasticity of the springs 14c and 14d. That is, a gap 14q is formed between the upper holder 14a and the sensor 23, and a gap 14r is formed between the lower holder 14b and the sensor 23. Since the gaps 14q and 14r are formed in this way, blood 10 or the like attached to the sensor 23 is not attached again to the upper holder 14a or the lower holder 14b and becomes dirty.

  FIG. 12C is a cross-sectional view showing a state where the sensor 23 is taken out. A pressing portion 18c connected to the discharge slider 18 further pushes up the tongue piece 14p of the lower holder 14b. Then, the space between the upper holder 14a and the lower holder 14b is further opened, and the sensor 23 is supported by the springs 14c and 14d and falls in a state of being floated between the upper holder 14a and the lower holder 14b.

  Thus, since the sensor 23 is supported and locked at one point by the springs 14c and 14d, it can be used without depending on the posture of the blood test apparatus 11, such as the inclination.

  FIG. 13 is a cross-sectional view of the discharge slider 18 provided on the side surface of the main body case 12 and the vicinity thereof. FIG. 13A is a cross-sectional view in the first state where the main body case 12 is housed in the cover case 13. The discharge slider 18 is locked on the opening 13j side of the cover case 13, and the discharge slider 18 cannot be slid. That is, the sensor 23 is prohibited from being discharged.

  The discharge slider 18 is connected to a pressing portion 18c that presses the tongue piece 14p of the lower holder 14b through a steel (flexible rigid body) 18b. Guides 18d and 18e are provided between the discharge slider 18 and the pressing portion 18c, and the traveling direction of the steel 18b is bent at a right angle. Further, the discharge slider 18 is biased upward in FIG. 13A by a spring 18f.

  FIG. 13B is a cross-sectional view of the second state in which the cover case 13 is pulled out from the main body case 12, the opening 13 j side of the cover case 13 is moved downward, and the discharge slider 18 is moved to the main body case 12. It is possible to slide in the slit 12c provided on the other side surface 12b. That is, the sensor 23 can be discharged.

  When the discharge slider 18 is moved downward against the force of the spring 18f, the pressing portion 18c moves to the left in the drawing. That is, the pressing portion 18c presses the tongue piece 14p of the lower holder 14b. As shown in FIG. 12 by the pressing operation by the pressing portion 18c, the lower holder 14b and the upper holder 14a are separated from each other, and the sensor 23 is discharged. When the force applied to the discharge slider 18 is removed, it is biased by the spring 18f, and the discharge slider 18 moves upward and returns to its original position. That is, the pressing of the tongue piece 14p is released, and the lower holder 14b returns to the original position.

  FIG. 14 is a cross-sectional view of a laser puncture unit 22 which is an example of puncture means. The laser puncture unit 22 includes an oscillation tube 22a and a cylindrical body 22b connected to the oscillation tube 22a. In the oscillation tube 22a, an Er: YAG (yttrium, aluminum, garnet) laser crystal 22c and a flash light source 22d (an example of a light source) are stored. A partial reflection mirror 22e having a reflectance of about 90% is attached to one end of the oscillation tube 22a, and a total reflection mirror 22f is attached to the other end. A convex lens 22g is installed in the cylindrical body 22b in front of the partial reflecting mirror 22e, and is set so that the laser beam 22h is focused on the patient's skin.

The operation of the laser puncture unit 22 configured as described above will be described below.
The puncture button 19 (see FIGS. 3 and 16) is pressed. Then, the flash light source 22d emits light. The light emitted from the flash light source 22d excites electrons in the Er: YAG laser crystal 22c to cause stimulated emission. The light generated by the stimulated emission is amplified by being repeatedly reflected and reciprocated among the total reflection mirror 22f, the YAG laser crystal 22c, and the partial reflection mirror 22e. A part of the amplified laser beam passes through the partial reflection mirror 22e. The laser beam 22h that has passed through the partial reflection mirror 22e is refracted by the lens 22g and focused under the skin 9. The depth of focus when puncturing is suitably 0.1 mm to 1.5 mm from the skin 9.

  In the present embodiment, the laser puncture unit 22 that can puncture the patient's skin 9 without contact is used, which is hygienic. In addition, there are no moving parts and there are fewer failures.

  FIG. 15 is a cross-sectional view of the main part when the measurement operation using the blood test apparatus 11 is performed. In FIG. 15, a negative pressure chamber 29a is formed on the lower surface of the lower holder 14b. The negative pressure chamber 29a has a hole 14m formed in the lower holder 14b, a hole 34g formed in the storage portion 34, and the upper holder 14a. Are connected to the negative pressure means 29 through the negative pressure path 29b. The negative pressure means 29 (see FIG. 6) is composed of a motor and a vacuum pump connected to the motor. The negative pressure generated by the vacuum pump is supplied to the negative pressure chamber 29a formed in the lower holder 14b via the negative pressure path 29b. A skin detection sensor 29c is provided on the convex portion that forms the periphery of the negative pressure chamber 29a. 49 (49a-49f) is a connector provided in the upper holder 14a, and is provided in order to contact the connection electrodes 41a-45a and the identification electrode 47a (see FIG. 8) formed in the sensor 23. Then, signals from the connection electrodes 41a to 45a and the identification electrode 47a are sent to the electric circuit unit 30 (see FIG. 16) via the connector 49. In addition, the positioning hole 36 formed in the sensor 23 is fitted and aligned with the positioning convex portion 14j formed in the upper holder 14a.

  The lower holder 14b of the blood test apparatus 11 configured as described above is brought into contact with the skin 9 of the finger 8 and the puncture button 19 (see FIG. 3) is pressed. Then, the laser beam 22h is emitted from the laser puncture unit 22. The laser light 22h penetrates the skin 9 through the hole 14g, the reservoir 34, and the hole 14m in a straight line. When the skin 9 is punctured, blood 10 oozes out from the skin 9 and blood drops 10 a are formed in the reservoir 34. The blood droplet 10a is taken into the detection unit 37 (see FIGS. 7 and 8) from the supply path 35 of the sensor 23 by capillary action and reacts with the reagent 40. The signal that has reacted with the reagent 40 is measured by the electric circuit unit 30 via the connector 49.

  FIG. 16 is a block diagram of the electric circuit unit 30 and its vicinity. In FIG. 16, connection electrodes 41a to 45a (see FIG. 8) of the sensor 23 are connected to the switching circuit 30a via connectors 49a to 49e. The output of the switching circuit 30a is connected to the input of the current / voltage converter 30b. The output is connected to the input of the arithmetic unit 30d via an analog / digital converter (hereinafter referred to as A / D converter) 30c. The output of the calculation unit 30d is connected to the display unit 17 and the communication unit 30e made of liquid crystal. A reference voltage source 30f is connected to the switching circuit 30a. The reference voltage source 30f may be a ground potential.

  Reference numeral 30g denotes a control unit. The output of the control unit 30g includes a high voltage generation circuit 30h connected to the laser puncture unit 22, a control terminal of the switching circuit 30a, a calculation unit 30d, a communication unit 30e, a negative pressure It is connected to the means 29 and the conveying means 28. In addition, a slide sensor 12d that detects the withdrawal of the cover case 13, a puncture button 19, a skin detection sensor 29c, a timer 30k, and a connector 49f are connected to the input of the control unit 30g.

  Here, it is also possible to turn on / off the main power supply of the blood test apparatus 11 using the signal of the slide sensor 12d that detects the state in which the cover case 13 is pulled out. That is, when the slide sensor 12d is off (the cover case 13 is not pulled out), the main power supply of the blood test apparatus 11 is off, and power supply to the display unit, the laser puncture unit, etc. is stopped. deep.

  When the slide sensor 12d is turned on (in a state where the cover case 13 is pulled out), the main power supply is turned on, internal electrical initial processing is performed, and power is supplied to the display unit and the like.

  Hereinafter, the operation of the electric circuit unit 30 will be described. First, the puncture button 19 is pressed and the skin 9 is punctured with the laser puncture unit 22. Then, the property of blood 10 exuded by puncture is measured. In the measurement operation, the switching circuit 30a is switched to connect the detection electrode 41 (see FIG. 8) to the current / voltage converter 30b. Further, a detection electrode 42 serving as a detection electrode for detecting inflow of blood 10 is connected to the reference voltage source 30f. A constant voltage is applied between the detection electrode 41 and the detection electrode 42. In this state, when blood 10 flows in, a current flows between detection electrodes 41 and 42. This current is converted into a voltage by the current / voltage converter 30b, and the voltage value is converted into a digital value by the A / D converter 30c. And it outputs toward the calculating part 30d. The calculation unit 30d detects that the blood 10 has sufficiently flowed based on the digital value. At this time, the operation of the negative pressure means 29 is turned off.

  Next, glucose, which is a blood component, is measured. In the measurement of the glucose component amount, first, the switching circuit 30a is switched by a command from the control unit 30g, and the detection electrode 41 serving as a working electrode for measuring the glucose component amount is connected to the current / voltage converter 30b. Further, a detection electrode 43 serving as a counter electrode for measuring the glucose component amount is connected to the reference voltage source 30f.

  Note that the current / voltage converter 30b and the reference voltage source 30f are kept off while glucose in the blood reacts with its oxidoreductase for a certain time. Then, after a certain time (1 to 10 seconds), a certain voltage (0.2 to 0.5 V) is applied between the detection electrodes 41 and 43 according to a command from the control unit 30g. Then, a current flows between the detection electrodes 41 and 43. This current is converted into a voltage by the current / voltage converter 30b, and the voltage value is converted into a digital value by the A / D converter 30c. And it outputs toward the calculating part 30d. The computing unit 30d converts the glucose component amount based on the digital value.

  After the measurement of the glucose component amount, the Hct (hematocrit) value is measured. The Hct value is measured as follows. First, the switching circuit 30a is switched by a command from the control unit 30g. Then, the detection electrode 45 serving as a working electrode for measuring the Hct value is connected to the current / voltage converter 30b. Further, the detection electrode 41 serving as a counter electrode for measuring the Hct value is connected to the reference voltage source 30f.

  Next, a constant voltage (2 V to 3 V) is applied between the detection electrodes 45 and 41 from the current / voltage converter 30b and the reference voltage source 30f according to a command from the control unit 30g. The current flowing between the detection electrodes 45 and 41 is converted into a voltage by the current / voltage converter 30b, and the voltage value is converted into a digital value by the A / D converter 30c. And it outputs toward the calculating part 30d. The calculation unit 30d converts the Hct value based on the digital value.

  Using the Hct value and the glucose component amount obtained in this measurement, the glucose component amount is corrected with the Hct value by referring to a calibration curve or a calibration curve table obtained in advance, and the corrected result is displayed on the display unit 17. To display. Which calibration curve or calibration curve table is used is determined based on the identification unit 47 in the sensor 23. Further, the calibration curve or the result corrected with the calibration curve table is transmitted from the communication unit 30e to the injection device for injecting insulin. For this transmission, radio waves can be used, but it is preferable to transmit by optical communication that does not interfere with the medical device.

  If the dose of insulin is automatically set in the injection device by transmitting the measurement data corrected in this way from the communication unit 30e, the amount of insulin administered by the patient is set in the injection device. There is no need, and the troublesome setting is eliminated. In addition, since the amount of insulin can be set in the injection device without using artificial means, setting errors can be prevented.

  The glucose measurement has been described above as an example, but the present invention can be applied to the measurement of blood components such as lactate and cholesterol in addition to glucose measurement by exchanging the reagent 40 of the sensor 23.

  Next, the test method of blood test apparatus 11 will be described using FIG. First, in step 51, the cover case 13 of the blood test apparatus 11 is pulled out. When the cover case 13 is pulled out, the slide sensor 12d is turned on, and the routine proceeds to step 52. At this time, the main power supply of blood test apparatus 11 may be turned on.

  In step 52, the conveying means 28 (see FIG. 6) is operated by the ON signal of the slide sensor 12d. Then, the sensor 23 is conveyed to the puncture unit 14 by the slide plate 27. This conveyance confirmation is performed by detecting the continuity between the connection electrode 43a of the sensor 23 and the identification electrode 47a. Thereafter, the slide plate 27 is returned to the standby state by the conveying means 28.

  Next, the process proceeds to step 53. In step 53, a display for prompting contact with the skin 9 (see FIG. 15) is performed on the display unit 17. In accordance with this display, the patient brings the puncture unit 14 into contact with the patient's skin 9. The contact with the skin 9 is performed by the output of the skin detection sensor 29c. When the contact with the skin 9 is confirmed, the routine proceeds to step 54 where the negative pressure means 29 is operated to apply a negative pressure into the negative pressure chamber 29 a provided in the puncture section 14. The skin 9 is raised by applying a negative pressure. Further, when the output of the skin detection sensor 29c is detected, the high voltage generation circuit 30h is operated to start high voltage charging of the capacitor.

  When the change of the current accompanying the operation of the negative pressure means 29 and the completion of the high voltage charge by the high voltage generation circuit 30h, or when a predetermined time has elapsed by the timer 30k, the high voltage charge sufficient for puncture and the storage unit 34 It is determined that the skin 9 is sufficiently raised, and the process proceeds to step 55. In step 55, the display unit 17 displays that puncturing is possible. Then, the process proceeds to step 56 and waits for pressing of the puncture button 19. When the puncture button 19 is pressed, the routine proceeds to step 57.

  It should be noted that the pressing operation of the puncture button 19 in this step 56 can be automated based on the display indicating that puncture is possible. At this time, it is desirable to notify the patient of the puncture timing by counting down. As a countdown method, visual notification to the display unit 17 (or the auxiliary display unit 67) is preferable because of concern for others.

  In step 57, the display performed in step 55 is turned off. Then, the process proceeds to step 58. In step 58, the exuded blood 10 (see FIG. 15) is taken into the reservoir 34 of the sensor 23 by puncturing the skin 9. The blood 10 taken into the storage part 34 is taken into the detection part 37 at a stretch (at a fixed flow rate) by capillary action by the supply path 35 formed in the sensor 23. Then, the blood sugar level of blood 10 is measured.

  When the blood glucose level is measured in step 58, the process proceeds to step 59 and the negative pressure means 29 is turned off. Then, the process proceeds to step 60. In step 60, the measured blood glucose level is displayed on the display unit 17. The negative pressure means 29 may be turned off when the blood 10 reaches the detection electrode 42.

  This completes the measurement of blood 10, and proceeds to step 61. In step 61, the discharge slider 18 is pushed down, and the sensor 23 is discharged out of the blood test apparatus 11. Then, the process proceeds to step 62. In step 62, the main body case 12 of the blood test apparatus 11 is stored in the cover case 13. Storage by the cover case 13 is detected by a slide sensor 12d. At this time, the main power supply of blood test apparatus 11 may be turned off.

(Embodiment 2)
The blood test apparatus 71 according to the second embodiment of the present invention is different from the first embodiment in that the sensor 23 is mechanically transported in conjunction with the pulling-out operation of the cover case 73 (corresponding to the cover case 13 in the first embodiment). 1 and different. The same components as those in the first embodiment are denoted by the same reference numerals, and the description is simplified.

  FIG. 18 is a perspective view of the first state in which the main body case 72 (corresponding to the main body case 12 in the first embodiment) is inserted into the cover case 73 as viewed from the back surface. The other side surface 73g of the cover case 73 protrudes from the opening 73j side, and forms a protruding portion 73k. A main body case 72 is inserted into the cover case 73, and the discharge slider 18 provided on the other side surface 72b of the main body case 72 is locked at the upper end 73m of the protruding portion 73k. Accordingly, in this state, the slide of the discharge slider 18 is prohibited, and the sensor 23 is not accidentally discharged. In addition, a power transmission portion 75a (corresponding to the power transmission portion 27a in the first embodiment) connected to the slide plate 27 is inserted into the hole 74 formed in the protruding portion 73k.

  FIG. 19 is a perspective view of the second state in which the cover case 73 is pulled out from the main body case 72 as seen from the back side. In this state, when the cover case 73 is pulled out, the power transmission portion 75 a inserted into the hole 74 also moves downward along the slit 76 in conjunction with the pulling operation of the cover case 73 into the hole 74. As a result, the sensor 23 is mechanically transported to the puncture unit 14.

  In this state, the finger insertion hole 15 is located at a position corresponding to the puncture portion 14, and the finger 8 can be inserted into the finger insertion hole 15 for puncture. Further, the discharge slider 18 provided on the other side surface 72b of the main body case 72 can be slid downward along the slit 12c. Accordingly, by sliding the discharge slider 18 in this state, the used sensor 23 that has been measured can be discharged.

  FIG. 20A is a cross-sectional view of the main part in the first state in which the main body case 72 is inserted into the cover case 73. In this state, the power transmission part 75a is inserted into the hole 74 formed in the protrusion 73k. When the cover case 73 is moved downward from this state, the power transmission portion 75a is pushed by the upper end 74a of the hole 74 and is downward (in the direction of the arrow in FIG. 20A) as shown by the dotted line in FIG. Move to. That is, by pulling out the cover case 73 from the main body case 72, the slide plate 27 (see FIG. 6) connected to the power transmission unit 75a moves, and the sensor 23 is conveyed to the puncture unit 14.

  The cover case 73 moves downward, and the arc 74b formed near the hole 74 rides on the lower end 76a of the slit 76 formed on the other side surface 72b. Then, the protrusion 74k moves in the direction of the arrow 77a. When the protruding portion 74k moves in the direction of the arrow 77a (rightward in FIG. 20B), the power transmission portion 75a is disengaged from the upper end 74a of the hole 74. When the engagement is released, the power transmission unit 75a is biased by the spring 77 and returns to the original position even if it moves in the direction indicated by the arrow 77b.

  Next, when the puncturing operation is finished and the main body case 72 is accommodated in the cover case 73, the power transmission unit 75a slides on the arc 74c formed on the upper end 74a side of the hole 74 and fits into the hole 74, Returning to the state shown in FIG.

  The blood test apparatus according to the present invention can be applied to the blood test apparatus because it is compact and easy to operate.

1 is an exploded perspective view of a blood test apparatus according to Embodiment 1 of the present invention. Whole perspective view of the 1st state accommodated in the cover case Whole perspective view of the second state withdrawn Whole perspective view of the 1st state seen from the back side Whole perspective view of the 2nd state seen from the back side Cross section of the main body Sectional view of the sensor housed in the cartridge Perspective plan view of the sensor External perspective view of the sensor The perspective view which looked at the upper holder which comprises the puncture part from the lower surface side The perspective view which looked at the same holder from the upper surface side The cross-sectional view of the puncture section when the sensor is excluded, (a) is a cross-sectional view of the state where the sensor is mounted, (b) is the cross-sectional view of the state where the lower holder starts to be separated from the upper holder, (c) ) Is a cross-sectional view of the sensor being discharged Sectional view of the discharge slider and its vicinity, (a) is a sectional view of the first state, (b) is a sectional view of the second state Sectional view of the laser puncture unit Cross-sectional view of the main part during the measurement operation Block diagram of the electrical circuit and its vicinity Flow chart of the inspection method The perspective view of the 1st state of the blood test apparatus in Embodiment 2 of this invention Perspective view of the second state The principal part sectional drawing of the conveyance means, (a) is principal part sectional drawing of the conveyance means in the 1st state which the cover case accommodates, (b) is the 2nd state where the cover case is pulled out Sectional view of the main part of the transport means A perspective view of a conventional blood test apparatus Top view when piercing the index finger Top view when puncturing the middle finger Top view when piercing the ring finger Top view when puncturing the little finger

Explanation of symbols

DESCRIPTION OF SYMBOLS 11 Blood test apparatus 12 Main body case 13 Cover case 14 Puncture part 15 Finger insertion hole 22 Laser puncture unit 23 Sensor 30 Electric circuit part

Claims (14)

A main body case having a puncture portion; a puncture means provided in the main body case and opposed to the puncture portion; a blood sensor attached to the puncture portion; and the blood sensor electrically connected And an electric circuit part that covers at least a part of the main body case and is slidable. When the cover case is pulled out, the cover case is in a position corresponding to the puncture part. A blood test apparatus provided with a finger insertion hole. When the cover case is pulled out, the puncture button that gives an activation signal to the puncture means is exposed, and when the main body case is housed in the cover case, the puncture button is covered and the use is prohibited. The blood test apparatus according to claim 1. The blood according to claim 1, wherein the blood sensor can be discharged when the cover case is pulled out, and the blood sensor is prohibited from being discharged when the main body case is housed in the cover case. Inspection device. One end of the cover case is disposed at a position that regulates a discharge slider that activates the discharge operation. When the cover case is pulled out, the restriction of the discharge slider is released, and the main body case is attached to the cover case. The blood test apparatus according to claim 3, wherein the blood test apparatus is configured to restrict the discharge slider and prohibit its use in the housed state. The blood test apparatus according to claim 1, wherein transport means for transporting the blood sensor is provided, and the blood sensor is transported to the puncture portion by pulling out the cover case. The blood test apparatus according to claim 5, wherein the blood sensor is transported to the puncture portion in a mechanically interlocking manner with the cover case pulling-out operation. The blood test apparatus according to claim 1, wherein in a state where the main body case is housed in the cover case, the puncture portion of the main body case is covered and use is prohibited. The blood test apparatus according to claim 1, wherein the puncturing means is a laser puncturing unit, and a cover case is provided at a position where the laser beam emitted from the laser puncturing unit is shielded. The blood test apparatus according to claim 1, wherein the main body case and the cover case are configured to be removable. The blood test apparatus according to claim 1, wherein the cover case is provided with a sensor disposal port for discharging the sensor. The blood test apparatus according to claim 1, wherein the power supply of the apparatus is turned off when the main body case is housed in the cover case, and the apparatus is turned on when the cover case is pulled out. The blood test apparatus according to claim 1, wherein the main body case includes a sensor cartridge capable of storing a plurality of sensors. The blood test apparatus according to claim 12, wherein the main body case includes a discharge button that activates a discharge operation of the sensor cartridge. One end of the cover case is disposed at a position that regulates the ejection button that activates the ejection operation of the sensor cartridge. When the cover case is pulled out, the regulation of the ejection button is released, and the body case is The blood test apparatus according to claim 13, wherein the blood test apparatus is configured to restrict the discharge button and prohibit its use in a state of being housed in the cover case.

Images