JP2009022405A - Blood testing equipment and test method using the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To solve the problem that since blood is adhered to a used sensor, it has to be wrapped up and then discarded. <P>SOLUTION: Blood testing equipment is provided with: a casing 22 having a puncture part 25; a sensor cartridge 24 which is provided inside the casing 22 and in which sensors 23 are laminates and stored; a conveying means 30 for conveying the sensors 23 to the puncture part 25 from the sensor cartridge 24 one by one; a laser emitter 26 provided oppositely to the puncture part 25; and an electric circuit 27 electrically connected to the sensors 23 conveyed to the puncture part 25. The equipment is provided with a film cartridge 17 where a film 16 is stored inside the casing 22 and it has a wrapping means 20 (the film cartridge 17, a holding part 18, and a pressing and cutting part 19) for wrapping the sensors 23b punctured by the laser emitter 26 with the film 16b guided from the film cartridge 17. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a blood test apparatus and a test method using the same.

  Hereinafter, a conventional blood test apparatus and a test method using the same will be described. FIG. 31 shows a conventional blood test apparatus 1 and FIG. 32 is a flowchart of a test method using the blood test apparatus 1.

  In FIG. 31, a conventional blood test apparatus 1 includes a housing 2 having a puncture portion 8, a sensor cartridge 4 provided in the housing 2 and containing a blood sensor (hereinafter referred to as a sensor) 3 in a stacked manner, Electrically connected to the transport means 5 for transporting the sensors 3a from the sensor cartridge 4 one by one to the puncture section 8, the puncture means 6 provided facing the puncture section 8, and the sensor 3a transported to the puncture section 8 The electric circuit unit 7 is configured.

  A blood test method using blood test apparatus 1 configured as described above will be described with reference to FIG. First, in step 11, blood test apparatus 1 is brought into contact with patient's skin 9 (see FIG. 31). Then, the process proceeds to step 12, and the puncture button 6b is pressed. Then, the puncture needle 6 a is fired from the puncture means 6 and punctures the skin 9. Blood 10 exudes by puncturing the skin 9.

  Next, the process proceeds to step 13. In step 13, the transport button 5b is pressed. Then, the lowermost sensor 3 a stacked and accommodated in the sensor cartridge 4 is conveyed to the puncture unit 8. And the blood 10 which exuded from the skin 9 is taken in in the sensor 3a. Next, the process proceeds to step 14. In step 14, the property of the blood 10 taken into the sensor 3a is measured by the electric circuit unit 7 electrically connected to the sensor 3a. When the measurement is completed, the process proceeds to step 15. In step 15, the sensor 3a to which the blood 10 is attached is removed from the puncture unit 8 and discarded.

As prior art document information related to the invention of this application, for example, Patent Document 1 and Patent Document 2 are known.
Special Table 2004-519302 Special table 2003-52496

  However, in such a conventional blood test apparatus 1, the sensor 3 a that has become contaminated due to the blood 10 must be removed from the puncture portion 8. When the sensor 3a is removed, the blood 10 attached to the sensor 3a may adhere to the patient's hand and become unsanitary. Moreover, in order to prevent reattachment of the blood 10 adhering to the sensor 3a, it is necessary to package it in something and discard it.

  As described above, even after the blood test, the patient must handle the sensor 3a contaminated with the blood 10 with utmost care and troublesome work.

  The present invention solves this problem and aims to provide a blood test apparatus in which a used sensor can be easily handled.

  In order to achieve this object, the blood test apparatus of the present invention is provided with a film cartridge in which a film is housed in a housing, and a package in which a blood sensor that has been punctured by puncturing means is packaged with the film derived from the film cartridge. It has a means. Thereby, the initial purpose can be achieved.

  As described above, the present invention comprises a packaging means for packaging a blood sensor that has been punctured by a puncturing means with a film derived from the film cartridge provided with a film cartridge containing a film in a housing, Since the punctured blood sensor is packaged with a film, the packaged blood sensor can be discarded as it is. Therefore, the patient does not need to package the punctured blood sensor, and the handling is easy. Further, the patient does not directly touch the used blood sensor to which blood has adhered, and is hygienic. Further, by disposing the film away from the focal point of the laser emitting device, blood is prevented from adhering to the lens of the laser emitting device.

(Embodiment 1)
Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a cross-sectional view of blood test apparatus 21 in the present embodiment. In FIG. 1, reference numeral 22 denotes a housing made of resin and having a substantially rectangular parallelepiped shape, and a puncture portion 25 is provided at a lower right corner (in the drawing) of the housing 22. A laser emitting device (used as an example of puncturing means) 26 is attached to face the puncturing unit 25.

  Reference numeral 24 denotes a sensor cartridge in which a blood sensor (hereinafter referred to as a sensor) 23 is stacked and accommodated and is detachably provided from the housing 22. The sensor cartridge 24 is formed integrally with the puncture portion 25. .

  A film cartridge 17 in which the film 16 is accommodated is integrally provided adjacent to the case 24 b of the sensor cartridge 24. A holding unit 18 is attached to the tip of the puncture unit 25. A pressing and cutting portion 19 for the film 16 is provided to face the holding portion 18. In the present embodiment, the holding means 18 and the push-cut section 19 constitute a packaging means 20. Since the punctured sensor 23 is packaged with the film 16 by the packaging means 20, the sensor 23 to which the blood 10 has adhered can be discarded in the packaged state. That is, the patient does not need to wrap the punctured sensor 23, and the handling is easy. Further, the patient does not directly touch the used sensor 23 to which the blood 10 has adhered, and is hygienic.

  An electric circuit section 27 and a battery 29 are accommodated above the laser emitting device 26, and a negative pressure means 28 is accommodated above the sensor cartridge 24.

  In the present embodiment, the laser emitting device 26 is used as the puncturing means, but this is not limited to the laser emitting device 26, and a needle puncturing device using a puncture needle may be used. In this case, the consumption of the battery 29 is reduced.

  Hereinafter, each component will be described. FIG. 2 is a cross-sectional view of the sensor 23 stacked and housed in the sensor cartridge 24. 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. 14). The reservoir 34 is formed in the substrate hole 31a formed in the approximate center of the substrate 31 and in the spacer 32 corresponding to 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 25 and is provided through the sensor 23.

  Reference numeral 35 denotes a supply path for blood 10 having one end connected to the storage section 34, and a path for introducing the blood 10 stored in the storage section 34 into the detection section 37 at once 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 0.904 μL, and the volume of the supply path 35 is 0.144 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 dissolving the solution, and the reagent solution is dropped on the detection unit 37 formed on the substrate 31 and dried. When the reagent 40 absorbs moisture, the performance deteriorates.

  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 detection electrodes 41 to 45 (see FIG. 3) are formed by laser processing. Yes. The connection electrodes 41a to 45a and the identification electrode 47a respectively derived from the detection 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. 3 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 electrode 47 formed of a conductor pattern is formed between the connection electrode 43a and the identification electrode 47a.

  Reference numeral 34 denotes a blood 10 storage part provided substantially in the 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. 2) is placed on the detection electrodes 41 and 43 forming the detection unit 37.

  Whether or not the sensor 23 is attached to the puncture unit 25 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 25, it is detected that the sensor 23 is surely attached to the puncture unit 25 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 25. In this case, a warning can be displayed on the display unit 50 (see FIG. 22) of the blood test apparatus 21.

  Further, by changing the electric resistance value of the identification electrode 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. 4 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.

  Further, a step is formed on the other end of the sensor 23 opposite to the side where the connection electrodes 41a to 45a and 47a are formed. That is, the positions of the end surface of the substrate 31 constituting the sensor 23 (the end surface opposite to the connection electrode) and the end surface of the spacer 32 (opposite to the connection electrode) or the end surface of the cover 33 (opposite to the connection electrode) are Unlike (refer to FIG. 2), a step is formed as the sensor 23.

  Accordingly, when the sensors 23 stacked in the sensor cartridge 24 are separated one by one, the step is used to separate them.

  Further, when the separated sensor 23 is transported to the puncture unit 25, the end surface and the step are regulated and the sensor 23 is transported to the puncture unit 25. Further, when the slider 24k (see FIG. 5) is only returned after being set on the puncture unit 25, the end face and the step are regulated so as not to interfere with the sensor 23. (Details of sensor transport will be described later).

  FIG. 5 is a perspective plan view of the sensor cartridge 24 and its periphery. A sensor outlet 24a is provided on the lower side surface of the case 24b of the sensor cartridge 24, and a puncture portion 25 is integrally provided in connection with the sensor outlet 24a. A holding portion 18 is provided at the tip of the puncture portion 25, and a film cartridge 17 containing a film 16 is mounted on the upper surface of the puncture portion 25 and the corner of the case 24b. A laser emitting device 26 is disposed opposite to the puncture unit 25.

  A sensor chamber 24c is provided in the case 24b, and the sensor 23 is stacked and accommodated in the sensor chamber 24c. A drying chamber 24d is provided in parallel with the sensor chamber 24c, and is connected to the sensor chamber 24c through a passage 24e provided above. Further, the desiccant 48 may be stored in the drying chamber 24d.

  Reference numeral 24f denotes a negative pressure path formed above the sensor chamber 24c, and negative pressure is supplied from the negative pressure path 24f to protect the inside of the sensor chamber 24c from moisture. Reference numeral 24g denotes a pressing plate that presses the stacked and stored sensor 23 downward, and a hole 24h is provided at a position corresponding to the storage portion 34 of the sensor 23 at the approximate center of the pressing plate 24g. Therefore, the negative pressure introduced from the negative pressure path 24f dries the storage portion 34 of each sensor 23 through the hole 24h, and protects the reagent 40 from deterioration. Further, the dry air supplied from the drying chamber 24d also dries the storage section 34 of each sensor 23 through the passage 24e, thereby protecting the reagent 40 from deterioration. 24j is a spring that presses the holding plate 24g downward.

  A slider 24k slides below the sensor chamber 24c, and the slider 24k conveys the lowermost sensor 23 to the outside of the sensor outlet 24a. The slider 24k is driven by the conveying means 30.

  FIG. 6 is a cross-sectional view of the puncture unit 25 and the vicinity thereof. The puncture unit 25 includes an upper holder 25a made of resin and a lower holder 25b provided to face the upper holder 25a. The upper holder 25a is fixed to the case 24b, and the lower holder 25b is urged toward the upper holder 25a by a leaf spring 25c. The sensor 23 conveyed from the sensor outlet 24a of the sensor cartridge 24 is sandwiched and fixed between the upper holder 25a and the lower holder 25b.

  The film 16 is led out from the film cartridge 17 fixed to the corners of the case 24b and the puncture unit 25, and is held by the holding unit 18 through the upper surface of the upper holder 25a. The holding portion 18 includes a rubber (elastic body having friction) 18a, a pressing member 18b that can be pressed toward the rubber 18a, and a leaf spring 18c that presses the pressing member 18b toward the rubber 18a. And the front-end | tip of the film 16 is inserted in this holding | maintenance part 18, and is pinched | interposed and fixed between the rubber 18a and the pressing member 18b.

  A pressing member 26m is slidably provided at the tip of the laser emitting device 26, and the pressing member 26m is urged downward by a spring 26n. The film 16 is inserted by lifting the pressing member 26m upward and passing it between the upper holder 25a.

  Next, FIG. 7 will be described. Reference numeral 28a represents a negative pressure chamber, and reference numeral 28c represents a negative pressure path connected to the negative pressure means 28 (see FIG. 1).

  The negative pressure chamber 28a is formed from a hole formed in the upper holder 25a constituting the puncture unit 25, a storage part 34 of the sensor 23, and a hole of the lower holder 25b which is another member constituting the puncture part 25. ing.

  Moreover, the negative pressure chamber 28a is connected to the negative pressure means 28 (refer FIG. 1) of the apparatus main body via the negative pressure path 28c which is a hole formed inside the upper holder 25a.

  The upper surface of the negative pressure chamber 28a is closed by the film 16 pressed by the pressing member 26m at the tip of the laser emitting device 26.

  Next, the operation in FIG. 7 will be described. First, when measuring blood components, the skin 9 (“finger”, which is an example of skin) is brought into contact with the skin contact surface (lower side in FIG. 7) of the lower holder 25b. At this time, the negative pressure chamber 28 a is sealed with the film 16 and the skin 9.

  By driving the negative pressure means 28 of the apparatus main body in this sealed state, the pressure inside the negative pressure chamber 28a is lowered through the negative pressure path 28c, and the skin 9 (finger) is sucked.

  As described above, the film 16 is arranged on the upper surface of the puncture unit 25, the negative pressure chamber 28a and the negative pressure path 28c are provided in the puncture unit 25, and the pressing member 26m at the tip of the laser emitting device 26 The film is regulated and negative pressure can be surely obtained.

  FIG. 8 is a perspective view of the sensor cartridge 24. Since the puncture part 25 is integrally provided in the case 24b, the puncture part 25 can be replaced simultaneously with the sensor cartridge 24. Accordingly, the puncture portion 25 that is in contact with the skin 10 or has a possibility of blood adhering from the skin for inspection every time during the inspection is hygienic because it is periodically replaced. Further, a connector 51 for transmitting the signal of the sensor 23 to the electric circuit unit 27 is provided on the side surface of the puncture unit 25. Reference numeral 17 denotes a film cartridge in which a film covering the sensor 23 is accommodated, and reference numeral 18 denotes a holding unit for holding the end of the film.

  FIG. 9 is a perspective view of the puncture unit 25 and its periphery. In FIG. 9, a push cutting unit 19 that pushes and cuts the film 16 into the holding unit 18 is provided above the holding unit 18 provided at the tip of the puncture unit 25. The push-cut section 19 is slidably attached above a discharge port 22a (not shown) for discharging the sensor 23 provided in the housing 22. The push cutting part 19 includes a knob 19a, a push member 19b connected to the lower side of the knob 19a, and a cutting blade 19c mounted in parallel with the push member 19b. The knob 19a can be manually slid up and down from the outside. The upper and lower sides of the knob 19a can be controlled electrically.

  18c is a spring that urges the pressing member 18b toward the rubber 18a. Reference numeral 51 denotes a connector provided on the upper surface of the puncture unit 25.

  FIG. 10 is a side view of the upper holder 25a constituting the puncture unit 25, and FIG. 11 is a perspective view of the upper holder 25a as viewed from the lower surface 25e side. The upper holder 25a is provided with a hole 25g penetrating from the upper surface 25f to the lower surface 25e. This hole 25g is provided facing the laser emitting device 26 (see FIG. 9), and is a hole through which the laser beam 26h (see FIG. 14) passes. In the needle puncture device using the puncture needle, the puncture needle penetrates the hole 25g. Further, when the sensor 23 is mounted in the puncture unit 25, it corresponds to the position of the storage unit 34 (see FIGS. 2, 3, and 4) provided in the sensor 23. Further, the lower portion of the hole 25g is bent in an “L” shape. The tip 25 h bent in the “L” shape corresponds to the position of the air hole 38 formed in the sensor 23. This is to ensure the effect of the capillary action of the supply path formed in the sensor 23. A negative pressure is supplied through the hole 25g.

  Reference numeral 25j denotes a protrusion provided between the opening 25d and the hole 25g, which is fitted into a positioning hole 36 (see FIG. 4) provided in the sensor 23 to position the sensor 23 in the advancing direction. It is. The protrusion 25j has a trapezoidal shape narrowed toward the hole 25g. Further, the thickness gradually increases from the direction of the opening 25d toward the hole 25g. Therefore, the sensor 23 is easily inserted and fixed.

  Reference numerals 25k denote positioning convex portions provided on both sides of the holder 25a, respectively, and are provided at positions just beside the holes 25g (positions in a direction perpendicular to the traveling direction of the sensor 23). The convex portion 25k is used to position the sensor 23 in the lateral direction (a direction perpendicular to the traveling direction of the sensor 23). Reference numeral 49 denotes a connector, which is provided on the opposite side of the opening 25d. The connector 49 is connected to the connection electrodes 41 a to 45 a and the identification electrode 47 a of the sensor 23, and is electrically connected to the connector 51 provided on the side surface of the puncture unit 25. The electrical circuit unit 27 is connected via the connector 51. In addition, you may provide the protrusion 25j and the convex part 25k in the lower holder 25b side.

  FIG. 12 is a cross-sectional view of the lower holder 25b, and is provided with a hole 25m communicating with a hole 25g formed in the upper holder 25a. A negative pressure chamber 28a that opens downward is connected to the hole 25m. A skin detection sensor 28b is provided adjacent to the negative pressure chamber 28a. The skin detection sensor 28b is connected to the electric circuit unit 27 via a connector 28e.

  The skin detection sensor 28b may use a mechanical switch or may detect electrical continuity. Further, it may be an optical sensor using a light emitting diode and a light receiving transistor, or may be a magnetic sensor. In the present embodiment as well, the skin detection sensor 28 b uses an electrical sensor that detects the conduction resistance of the skin 9. Therefore, the battery 29 is not consumed.

  FIG. 13 is a cross-sectional view of the laser emitting device 26. The laser emitting device 26 includes an oscillation tube 26a and a cylindrical body 26b connected to the oscillation tube 26a. In the oscillation tube 26a, an Er: YAG (yttrium, aluminum, garnet) laser crystal 26c and a flash light source 26d (an example of a light source) are stored. The flash light source 26d is connected to a high voltage generation circuit 27h (see FIG. 22) provided in the electric circuit unit 27.

  A partial transmission mirror 26e having a transmittance of about 1% is attached to one end of the oscillation tube 26a, and a total reflection mirror 26f is attached to the other end. A convex lens 26g is mounted in the cylindrical body 26b in front of the partial transmission mirror 26e, and is set so as to focus on the patient's skin with the laser light 26h.

  The operation of the laser emitting device 26 configured as described above will be described below. When the skin detection sensor 28b (see FIGS. 12, 14, and 22) detects the skin 9, the predetermined time measured by the timer 27k (see FIG. 22) elapses or is supplied to the negative pressure means 28. The high voltage generation circuit 27h) is driven by the conditions of either the time point when the current change is detected, one of the above two time points, or the time point when the high voltage generation circuit 27h is sufficiently charged, and the flash light source 26d Is excited. The light emitted from the flash light source 26d enters the Er: YAG laser crystal 26c, where it is reflected by the total reflection mirror 26f, the YAG laser crystal 26c, and the partial transmission mirror 26e and resonates and is amplified. . A part of the amplified laser light passes through the partial transmission mirror 26e by stimulated emission. The laser beam 26h that has passed through the partial transmission mirror 26e is emitted through the lens 26g and is focused under the skin 9. The depth of focus when puncturing is suitably 0.1 mm to 1.5 mm from the skin 9, and is 0.5 mm in the present embodiment.

  In this embodiment, since the laser emitting device 26 that can puncture the patient's skin 9 without contact is used, it is hygienic. In addition, there are no moving parts and there are fewer failures. The puncture voltage with this laser beam 26h is set to 300V to 500V. Therefore, there is little pain to the patient.

  The negative pressure means 28 (refer FIG. 1) is comprised with the motor and the pump. The negative pressure generated by the negative pressure means 28 is guided to the negative pressure chamber 28a of the puncture unit 25 through the negative pressure path 28c (see FIG. 14). Moreover, it is also led to the sensor chamber 24c via the negative pressure path 24f (see FIG. 5). Switching of the negative pressure between the negative pressure path 28c and the negative pressure path 24f is performed by a switching valve 28d (not shown). The control of the switching valve 28d and the ON / OFF control of the negative pressure means 28 are controlled by the electric circuit section 27. Further, the negative pressure means 28 has a current change detection unit that detects a change in current.

  FIG. 14 is a cross-sectional view of the main part when the puncturing operation using the blood test apparatus 21 is performed. Here, in order to simplify the description, portions related to the film 16 are omitted. Parts related to the film 16 will be described in detail with reference to FIG.

  In FIG. 14, a negative pressure chamber 28a is formed on the lower surface of the lower holder 25b. The negative pressure chamber 28a has holes 25m formed in the lower holder 25b, holes formed in the storage portion 34, and the upper holder 25a. 25g and the negative pressure path 28c are connected to the negative pressure means 28. A skin detection sensor 28b is provided on the convex portion that forms the periphery of the negative pressure chamber 28a. Reference numerals 49 (49a to 49f) denote connectors provided on the upper holder 25a, which are provided corresponding to the connection electrodes 41a to 45a and the identification electrode 47a (see FIGS. 3 and 4) formed on the sensor 23. The connectors 49 (49a to 49f) are respectively connected to the connectors 51 (51a to 51f). That is, signals from the connection electrodes 41 a to 45 a and the identification electrode 47 a are guided to the electric circuit unit 27 through the connector 49 and the connector 51.

  When blood test apparatus 21 configured as described above is brought into contact with skin 9, a signal is output from skin detection sensor 28b. A signal output from the skin detection sensor 28 b is guided to the electric circuit unit 27. A laser beam 26h is automatically emitted from the laser emitting device 26 when the puncturing button is pressed or the puncturing conditions are adjusted. This laser beam 26h penetrates the skin 9 through the hole 25g, the reservoir 34, and the hole 25m 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 FIG. 3) and reacts with the reagent 40. The signal that has reacted with the reagent 40 is measured by the electric circuit unit 27 via the connectors 49 and 51. At this time, the sensor 23 is contaminated by the exuded blood 10.

  Hereinafter, operation | movement of the packaging means 20 is demonstrated using FIGS. 15-21. In the present embodiment, the packaging means 20 includes a holding portion 18 that fixes and holds the end of the film 16, and a push-cut portion 19 that cuts the film 16 after packaging the sensor 23 after use with the film 16. Has been.

  FIG. 15 shows the first state, in which the film 16 is led out from the film cartridge 17. The derived film 16 passes between the puncture portion 25 and the pressing member 26m. At this time, the pressing member 26m is lifted upward against the urging force of the spring 26n (see FIG. 6). And a clearance gap is formed between the puncture part 25 and the press member 26m, and the film 16 is passed through this clearance gap. When the pressing member 26m is released, the space between the puncture portion 25 and the pressing member 26m is closed by the force of the spring 26n.

  A gap is formed between the pressing member 18b provided on the holding portion 18 and the rubber 18a against the urging force of the leaf spring 18c. And the front-end | tip of the film 16 is inserted in this clearance gap, and the pressing member 18b is released. The pressing member 18b is pressed and fixed to the rubber 18a side together with the film 16 by the plate spring 18c. In this state, the push-cut part 19 is located above, and the slider 24k is located inside the sensor cartridge 24.

The film 16 used here allows the YAG laser beam 26h having a wavelength of 294 nm to pass therethrough, and polyethylene, polypropylene, polyimide, or the like can be used.
Since the film 16 is formed of a material that transmits the laser beam 26h, the film 16 does not interfere with the transmission of the laser beam 26h. Further, since the film 16 is separated from the skin 9 that is the puncture position by at least the distance formed by the thickness of the lower holder 25b, the sensor 23, and the upper holder 25a, the film 16 is also sufficient from the focal position of the laser beam 26h. It will be arranged at a distant position. Therefore, the laser beam 26h does not open the film 16 and break it. Therefore, it is possible to prevent the lens 26g of the laser emitting device from being contaminated with the blood 10 that has exuded after puncturing the skin.

  A film detection sensor 18d (not shown) for detecting that the film 16 has been inserted is provided between the rubber 18a of the holding portion 18 and the pressing member 18b. The signal of the film detection sensor 18d is an electric circuit. Connected to the unit 27.

  FIG. 16 shows the second state. In this second state, puncturing by the laser emitting device 26 has been completed. The slider 24k is moved in the direction of the discharge port 22a, and the sensor 23 is pushed out from the discharge port 22a. At this time, the used sensor 23 b is pushed out so as to be wrapped with the film 16.

FIG. 17 shows the third state. In this third state, the used sensor 23 b wrapped in the film 16 is left behind and the slider 24 k is returned into the sensor cartridge 24.
FIG. 18 shows the fourth state. In this fourth state, the push cutting part 19 is lowered and the film 16 is pushed between the rubber 18a of the holding part 18 and the pressing member 18b by the push member 19b.

  FIG. 19 shows the fifth state. In this fifth state, the push-cut section 19 is further lowered and the film 16 is cut by the cutting blade 19c. The sensor 23 wrapped in the film 16 by this cutting is separated from the blood test apparatus 21.

  FIG. 20 shows a sixth state. In this sixth state, the push-cut section 19 is raised and separated from the holding section 18. The end of the remaining cut film 16 is sandwiched and fixed between the rubber 18a and the pressing member 18b by the pressing force of the leaf spring 18c. Thus, the relationship between the film 16 and the holding portion 18 returns to the initial relationship (FIG. 15).

  FIG. 21 shows a state where the packaged sensor 23 b is separated by the packaging means 20. Since the width of the film 16 is sufficiently larger than the width of the blood sensor 23b, leakage of blood or the like from the blood sensor can be prevented.

  FIG. 22 is a block diagram of the electric circuit unit 27 and the vicinity thereof. In FIG. 22, connection electrodes 41a to 45a (see FIG. 3) of the sensor 23 are connected to a switching circuit 27a via connectors 49a to 49e and connectors 51a to 51e. The output of the switching circuit 27a is connected to the input of the current / voltage converter 27b. The output is connected to the input of the arithmetic unit 27d via an analog / digital converter (hereinafter referred to as A / D converter) 27c. The output of the calculation unit 27d is connected to the display unit 50 and the transmission unit 27e formed of liquid crystal. A reference voltage source 27f is connected to the switching circuit 27a. The reference voltage source 27f may be a ground potential.

  Reference numeral 27g denotes a control unit. The output of the control unit 27g includes a high voltage generation circuit 27h to which the laser emitting device 26 is connected, a control terminal of the switching circuit 27a, a calculation unit 27d, a transmission unit 27e, and a negative pressure. The means 28 and the conveying means 30 are connected. Further, the input of the control unit 27g is connected to the film detection sensor 18d that detects the attachment of the film 16 to the holding unit 18, the calculation unit 27d, the skin detection sensor 28b, the timer 27k, and the identification electrode 47a. A connector 49f is connected.

  Hereinafter, the operation of the electric circuit unit 27 will be described. First, when the skin detection sensor 28b detects the skin 9, the negative pressure means 28 is turned on based on the detection signal of the skin 9. Subsequently, the laser emitting device 26 punctures the skin 9. And the property of the blood 10 exuded by this puncture is measured. In the measurement operation, the switching circuit 27a is switched to connect the detection electrode 41 (see FIG. 3) to the current / voltage converter 27b. Further, a detection electrode 42 serving as a detection electrode for detecting the inflow of blood 10 is connected to the reference voltage source 27f. 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 27b, and the voltage value is converted into a digital value by the A / D converter 27c. And it outputs toward the calculating part 27d. The computing unit 27d detects that the blood 10 has sufficiently flowed based on the digital value. At this time, the operation of the negative pressure means 28 is turned off.

  Next, glucose, which is a blood component, is measured. In the measurement of the glucose component amount, first, the switching circuit 27a is switched by a command from the control unit 27g, and the detection electrode 41 serving as a working electrode for measuring the glucose component amount is connected to the current / voltage converter 27b. In addition, a detection electrode 43 serving as a counter electrode for measuring the glucose component amount is connected to the reference voltage source 27f.

  Note that the current / voltage converter 27b and the reference voltage source 27f are kept off while glucose in the blood reacts with its oxidoreductase for a certain period of time. Then, after a certain time (1 to 10 seconds) has elapsed, a certain voltage (0.2 to 1 V) is applied between the detection electrodes 41 and 43 according to a command from the control unit 27g. Then, a current flows between the detection electrodes 41 and 43. This current is converted into a voltage by the current / voltage converter 27b, and the voltage value is converted into a digital value by the A / D converter 27c. And it outputs toward the calculating part 27d. The computing unit 27d converts it into a glucose component amount based on the digital value.

  After the measurement of the glucose component amount, the Hct value is measured. The Hct value is measured as follows. First, the switching circuit 27a is switched by a command from the control unit 27g. Then, the detection electrode 45 serving as a working electrode for measuring the Hct value is connected to the current / voltage converter 27b. Further, the detection electrode 41 serving as a counter electrode for measuring the Hct value is connected to the reference voltage source 27f.

  Next, a constant voltage (2 V to 3 V) is applied between the detection electrodes 45 and 41 from the current / voltage converter 27b and the reference voltage source 27f according to a command from the control unit 27g. The current flowing between the detection electrodes 45 and 41 is converted into a voltage by the current / voltage converter 27b, and the voltage value is converted into a digital value by the A / D converter 27c. And it outputs toward the calculating part 27d. The computing unit 27d 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 50. To display. Which calibration curve or calibration curve table is used is determined based on the identification electrode 47 in the sensor 23. Further, the calibration curve or the result corrected by the calibration curve table is transmitted from the transmitter 27e 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.

  By transmitting the measurement data corrected in this way from the transmission unit 27e, if the dose of insulin is automatically set in the injection device, 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, a method for examining blood 10 will be described with reference to FIG. First, in step 60, the attachment of the film 16 to the holding unit 18 is detected. The attachment of the film 16 is detected by a film detection sensor 18d. Further, the sensor outlet 24a provided in the sensor cartridge 24 is opened.

  If there is an output from the film detection sensor 18d, the display unit 50 displays that the skin 9 should be brought into contact with the puncture unit 25. Following the display, the process proceeds to step 61. In step 61, the patient brings the blood test apparatus 21 into contact with the skin 9 according to the instruction of the display unit 50. The contact with the skin 9 is performed by the output of the skin detection sensor 28b.

  Next, the process proceeds to step 62. In step 62, the conveying means 30 is automatically driven by a signal from the skin detection sensor 28b. The bottom sensor 23 a in the sensor cartridge 24 is separated and conveyed to the puncture unit 25. This conveyance is confirmed by detecting the continuity between the connection electrode 43a of the sensor 23a and the identification electrode 47a.

  The process proceeds to step 63 on condition that the skin detection sensor 28b is output, and the negative pressure means 28 is operated. Then, negative pressure is applied to the negative pressure chamber 28 a provided in the puncture unit 25. The high voltage generation circuit 27h starts charging.

  The skin 9 is raised by applying a negative pressure. Either a change in current accompanying the operation of the negative pressure means 28, or a predetermined time (3 to 10 seconds) by the timer 27k, and the completion of charging (4 to 10 seconds) by the high voltage generation circuit 27h are detected. Accordingly, it is determined that the skin 9 in the storage unit 34 is sufficiently raised by the negative pressure and the charge necessary for puncturing is completed, and the process proceeds to step 64.

  Then, the skin 9 is punctured by the laser emitting device 26. The puncture may be performed by connecting a puncture button 27j to the control unit 27g and detecting the depression of the puncture button 27j. When the skin 9 is punctured, the exuded blood 10 becomes the sensor 23b attached with the blood 10. And it is taken in into the storage part 34 of this sensor 23b. The blood 10 taken into the reservoir 34 is introduced into the detection electrode 42 (see FIG. 3) at once (at a fixed flow rate) by capillary action by the supply path 35. When the blood 10 reaches the detection electrode 42, the operation of the negative pressure means 28 is automatically turned off, and the routine proceeds to step 65.

  In step 65, the blood 10 has already been taken into the detection unit 37, and the blood sugar level of the blood 10 is measured. It should be noted that the negative pressure means 28 may be automatically turned off when the blood glucose level measurement is completed. In this case, since the patient can recognize that the measurement is being performed by the operation of the negative pressure means 28, care can be taken not to swing the blood test apparatus 21 during the measurement.

  Next, the process proceeds to step 66, and the blood glucose level measured by the electric circuit unit 27 is displayed on the display unit 50. The blood glucose level measurement result may be automatically transmitted from the transmitter 27e toward the injection device. Then, the process proceeds to step 67. In step 67, the conveyance means 30 is operated and the sensor 23b is discharged from the discharge port 22a. Then, the process proceeds to step 68 where the punctured sensor 23b is packaged by the packaging means 20. The packaged sensor 23b is separated from the blood test apparatus 21.

  Then, the process proceeds to step 69. In step 69, negative pressure is supplied to the predetermined time sensor cartridge 24. This is to delay deterioration of the sensor 23 due to moisture. When the filling of the negative pressure into the sensor cartridge 24 is completed, the power supply of the blood test apparatus 21 is automatically turned off.

  As described above, the used sensor 23b is packaged by the holding unit 18 and the push-cut unit 19 constituting the packaging means 20 in step 68, so that there is no troublesomeness regarding the handling of the used sensor 23b.

  Further, since the puncture is performed by penetrating the storage part 34 (see FIG. 14), all the exuded blood 10 is accumulated in the storage part 34 and used for the blood test. Therefore, since all the exuded blood 10 is used effectively, there is no need to use wasted blood and the burden on the patient is minimized.

(Embodiment 2)
FIG. 24 is a perspective plan view of blood test apparatus 71 in the second embodiment. In the present embodiment, the operation of the slider 75k by the transport unit 76 and the transport of the sensor 23 are mainly described. Note that the same components as those in the first embodiment are denoted by the same reference numerals, and the description is simplified.

  In FIG. 24, reference numeral 72 denotes a casing, and a sensor cartridge 74 in which the sensors 23 are stacked and accommodated is detachably mounted in the casing 72. Below the sensor cartridge 74, a conveying means 76 for operating the slider 75k is provided, and the lowermost sensor 23 stacked and accommodated in the sensor cartridge 74 is separated by the slider 75k and conveyed to the puncture unit 25. To do.

  A laser emitting device 26 is provided above the puncturing unit 25 so as to face the puncturing unit 25, and an electric circuit unit 27 and a battery 29 are stored above the laser emitting device 26. A negative pressure means 28 is stored above the sensor cartridge 74.

  A film cartridge 17 is mounted on the case 74 b of the sensor cartridge 74 and the upper corner of the puncture unit 25. Further, a holding part 18 and a push-cut part 19 are provided at the tip of the puncture part 25. A discharge port 72a is provided on the downstream side of the holding unit 18 and the push-cut unit 19, and a locking means 70 for the sensor 23b is provided in the discharge port 72a.

  The locking means 70 includes a locking member 70a having elasticity and formed of a heating element, and a pedestal 70b provided to face the locking member 70a. The locking means 70 has a function of locking the sensor 23b in cooperation with the pedestal 70b while the locking member 70a enters the positioning hole 36 formed in the sensor 23b. Further, in the state where the sensor 23b is locked, a current is passed through the locking member 70a to generate heat, and the film 16 (see FIG. 25) is adhered, and the sensor 23b (see FIG. 27) is packaged. The film 16 may be a hot melt sheet that melts with heat.

  The sensor cartridge 74 in the present embodiment is formed independently, and the puncture unit 25, the film cartridge 17, the holding unit 18, and the conveying means 76 are integrated as in the sensor cartridge 24 in the first embodiment. It is not a thing. Therefore, a small and low-cost sensor cartridge 74 can be realized.

  Since the upper holder 25a is fixed to the casing 72 and the laser emitting device 26 is also fixed to the casing 72, the distance from the laser emitting device 26 to the lower holder 25b is accurately constant. Therefore, it is possible to puncture the puncture depth with the set value. This is the same even if the lower holder 25b is fixed and the upper holder 25a is varied.

  Next, the operation of the sensor 23 will be described with reference to FIGS. FIG. 25 shows the first state of the slider 75k. The slider 75k conveys the lowermost sensor 23a stacked and accommodated in the sensor cartridge 74 to the puncture unit 25. This transport is performed between the upper holder 25a and the lower holder 25b while pushing the lower holder 25b biased upward by a spring in a state where the sensor 23a is placed on the mounting portion 75u provided at the tip of the slider 75k. insert. This conveyance is stopped by detecting the identification electrode 47 of the sensor 23a. At this time, the protrusion 25j provided on the upper holder 25a is engaged with the positioning hole 36 formed in the sensor 23a for positioning.

  FIG. 26 shows the second state of the slider 75k. In the sensor 23a, the positioning hole 36 is engaged with the protrusion 25j. Accordingly, the slider 75k can be returned toward the sensor cartridge 24 while leaving the sensor 23a in the puncture portion 25. At this time, the placement portion 75u of the slider 75k on which the sensor 23a is placed stops in the middle of the length (front-rear) direction of the sensor 23c stacked and accommodated. This prevents the new sensor 23c from being placed on the placement portion 75u. In this state, puncture is performed by operating the laser emitting device 26. Blood 10 is taken into sensor 23b by sensor 23a by puncture.

  FIG. 27 shows a third state of the slider 75k. The slider 75k is advanced again, and the used sensor 23b that has been punctured is placed on the placement portion 75u. At this time, the new sensor 23c remains in the sensor cartridge 74 as it is.

  FIG. 28 shows a fourth state of the slider 75k. The slider 75k is further advanced to discharge the used sensor 23b from the discharge port 72a while being wrapped by the film 16. The conveyance is stopped at the position where the locking member 70a is locked in the positioning hole 36 of the used sensor 23b.

  FIG. 29 shows a fifth state of the slider 75 k, and the used sensor 23 b is separated from the slider 75 k and returns the slider 75 k into the sensor cartridge 74. At this time, the used sensor 23b is locked to the locking means 70. And the new sensor 23c is mounted in the mounting part 75u of the slider 75k.

  In this state, the holding unit 18 and the push-cut unit 19 cooperate to push the film 16 into the holding unit 18 and cut the film 16 with a slight delay. Subsequently, the locking member 70a is caused to generate heat. Then, the film 16 sandwiched between the base 70b and the locking member 70a is bonded in the positioning hole 36 of the sensor 23b. By bonding, the sensor 23b wrapped in the film 16 is not exposed or spilled.

  FIG. 30 shows the sixth state, in which the slider 75k remains at the same position. When the used sensor 23b wrapped in the film 16 is pulled forward, the used sensor 23b is separated from the blood test apparatus 71 in a packaged state. Immediately before the separation, the film 16 may be bonded by applying heat to the locking member 70a again.

  Since the locking member 70a is inclined forward, it can be easily pulled forward. The used sensor 23b that has been pulled out and separated is packaged and sealed in the film 16, so that not only the labor of packaging is saved but also the hands are not soiled.

  Since the laser puncture device according to the present invention places little burden on the patient in discarding the punctured sensor, the laser puncture device can be applied to uses such as medical devices that require blood collection or the like.

Sectional drawing of the blood test apparatus in Embodiment 1 of this invention Cross section of the sensor used in the blood test device Same perspective plan view of sensor Same external perspective view of sensor The same perspective view of the sensor cartridge housed in the blood test apparatus and its surroundings Same as above, sectional view of the main part around the puncture part Same as above, a puncture section having a negative pressure chamber and a negative pressure path, and a waist cross-sectional view of the peripheral portion Same perspective view of sensor cartridge Same as above, perspective view of main part of puncture part and main body of sensor cartridge Side view of the upper holder constituting the puncture unit Same as above, perspective view of upper holder Sectional drawing of the lower holder which comprises a puncture part similarly Cross section of the laser emission device Same as above, cross-sectional view of the puncture state First, sectional view of the puncture portion and the vicinity thereof Same as above, second sectional view Third sectional view of the same 4th state sectional view Same as above, fifth sectional view The sixth state sectional view Same as above, seventh sectional view Same as above, block diagram of electrical circuit and its vicinity Same as above, flowchart of inspection method The perspective plan view of the blood test apparatus according to the second embodiment First, sectional view of the puncture portion and the vicinity thereof Same as above, second sectional view Third sectional view of the same 4th state sectional view Same as above, fifth sectional view The sixth state sectional view Sectional view of a conventional blood test device Same as above, flowchart of inspection method

Explanation of symbols

DESCRIPTION OF SYMBOLS 16 Film 17 Film cartridge 18 Holding | maintenance part 19 Push cutting part 20 Packing means 21 Blood test apparatus 22 Case 23 Sensor 23b Used sensor 24 Sensor cartridge 25 Puncture part 26 Laser emission apparatus 27 Electric circuit part 30 Conveyance means

Claims (16)

A housing having a puncture portion; a sensor cartridge provided in the housing and having a blood sensor stacked therein; transport means for transporting the blood sensors one by one from the sensor cartridge to the puncture portion; and the puncture portion A puncture means provided opposite to the puncture portion, and an electric circuit portion electrically connected to the blood sensor conveyed to the puncture portion, and a film cartridge in which a film is housed in the housing is provided. A blood test apparatus comprising packaging means for packaging a blood sensor that has been punctured by the puncturing means with a film derived from a film cartridge. The blood test apparatus according to claim 1, wherein a member that transmits laser light is used for the film, and a laser emitting device is used for the puncturing means. The blood according to claim 1, wherein the wrapping means comprises a holding part that holds the film through between the puncturing means and the puncturing part, and a push cutting part that cuts after the film is pushed into the holding part. Inspection device. The film is disposed between the puncture means and the puncture portion that holds the blood sensor, and has a function of preventing dirt on the puncture means against scattering of dirt or blood during puncture. 4. The blood test apparatus according to any one of 3. The blood test apparatus according to claim 1, wherein the packaging unit includes a thermocompression bonding unit that thermocompresses and wraps the film. The blood test apparatus according to claim 1, wherein the blood sensor is discharged from a discharge port provided in the housing by a conveying unit, and a locking unit that locks the sensor is provided in the discharge port. The blood test apparatus according to claim 6, wherein the blood sensor is packaged by the packaging means in a state where the blood sensor is locked by the locking means. The blood test apparatus according to claim 1, wherein the sensor cartridge and the puncture unit are integrated. The blood test apparatus according to claim 1, wherein the sensor cartridge and the film cartridge are integrated. The blood test apparatus according to claim 1, wherein the puncture portion is formed by a holder for fixing the conveyed blood sensor, and pierces through the storage portion of the blood sensor fixed to the holder. The blood test apparatus according to claim 10, wherein the holder includes a first holder and a second holder, and the blood sensor is sandwiched and fixed by the first and second holders. The blood test apparatus according to claim 11, wherein a protrusion is provided on the first holder or the second holder, and the protrusion is fitted with a positioning hole formed in the blood sensor to position the blood sensor. A negative pressure means for negatively applying pressure to the skin in the vicinity of the puncture portion, a negative pressure chamber is formed by the film and the puncture portion holding the blood sensor, and the negative pressure chamber is negatively pressured by the negative pressure means; The blood test apparatus according to claim 1. It is a test | inspection method using the blood test apparatus of Claim 1, Comprising: The 1st step which abuts the puncture part formed in the said blood test apparatus to skin, and a puncture after this 1st step A test method using a blood test apparatus, comprising: a second step of puncturing the skin using a means; and a third step of packaging the punctured blood sensor after the second step. A method using the blood test apparatus according to claim 3, wherein the packaging means holds the film between the puncture means and the puncture part with a holding part, and after the holding step. Then, after the puncturing / measurement is completed in the blood test apparatus, a transporting step of transporting the film held by the holding unit by the punctured blood sensor to the outside of the housing by the transporting means, and the transporting step A second holding step for holding the film so as to enclose the used blood sensor, and a cutting for cutting the film in which the blood sensor is packaged by a push cutting unit after the second holding step. A test method using a blood test apparatus having steps. A test method using the blood test apparatus according to claim 5, wherein the packaging means holds the film between the puncture means and the puncture part with a holding part, and a first holding step. After the puncture / measurement is completed in the blood test apparatus later, a conveyance step of conveying the outside of the housing while pushing the film held by the holding unit with the punctured blood sensor by the conveyance means, and this conveyance step Thereafter, a second holding step for holding the film so as to enclose the used blood sensor therein, and after this second holding step, the film on which the blood sensor is packaged is thermocompression bonded by a thermocompression bonding section. A test method using a blood test apparatus having a sealing step for sealing.

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