JP2010104417A - Extraction cartridge and extraction medium storing tool used for organism ingredient analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an organism ingredient analyzer where a high measurement precision can be maintained by the prevention of extraction media from evaporation or leakage from a liquid storing part. <P>SOLUTION: The organism ingredient analyzer includes: an extraction medium holder 53 to hold an extraction medium that holds an extract from the skin of a subject; a reactor 54 to produce certain reactions from the extract, a detector 40 to detect the extract from the certain reactions produced by the reactor 54; an extraction medium storing part 52 to store the extract medium; an extraction medium transferrer to transfer the extraction medium stored in the extraction medium storing part 52 to the extraction medium holder 53, and to transfer at least part of the extraction media, which have been transferred to the extraction medium holder 53 and holding extracts from subjects, to the reactor 54 from the extraction medium holder 53, and an analyzer 17 to analyze the results of detection by the detector 40. The extraction medium storing part 52 is a container made of a thin metal membrane. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a biological component analyzer, an extraction cartridge used in the apparatus, and an extraction medium container.

  2. Description of the Related Art Conventionally, biological component analyzers that perform analysis by reacting extracted glucose by extracting an analyte such as glucose from a subject and then using an enzyme such as glucose oxidase as a catalyst are known (for example, patents). Reference 1).

  Patent Document 1 contains a reaction unit in which glucose reacts with glucose oxidase as a catalyst, an extraction unit configured to hold an extraction medium for holding glucose extracted from a subject, and an extraction medium. A biological component analyzer including a syringe pump that provides (transfers) a medium to each unit is disclosed. In this biological component analyzer, the syringe pump provides the stored extraction medium to the extraction unit, and after the glucose is extracted to the extraction medium in the extraction unit, further provides the extraction medium from the syringe pump to the extraction unit. Thus, the extraction medium holding glucose is transferred (extruded) from the extraction unit to the reaction unit.

  However, in the biological component analyzer described in Patent Document 1, after the glucose is extracted to the extraction medium in the extraction unit, the extraction medium holding glucose is extracted by further providing the extraction medium to the extraction unit from the syringe pump. Since it is configured to be transferred (extruded) from the reaction part to the reaction part, the glucose in the extraction part is held in the extraction medium from the syringe pump for pushing the extraction medium holding the glucose in the extraction part to the reaction part side. There is a possibility that the extraction medium comes into contact and glucose is mixed into the extraction medium from the syringe pump. If glucose is mixed in the extraction medium outside the extraction unit in this way, the glucose concentration in the extraction medium becomes non-uniform, and the analysis accuracy may be reduced.

  Therefore, the applicant adopts an air pump instead of a syringe pump as a means for transferring the extraction medium, and a device for transferring the extraction medium to the extraction unit and the extraction medium from the extraction unit to the reaction unit by air. Proposed jointly (Japanese Patent Application No. 2008-91599).

  In the biological component analyzer according to Japanese Patent Application No. 2008-91599, an amount that can be held by an extraction medium holding unit (a portion configured to hold a predetermined amount of extraction medium for holding an extract extracted from a subject). And a liquid storage unit that stores an extraction medium of approximately the same amount as the above. And by the liquid transfer part provided with the air pump, while extracting the extraction medium accommodated in the said liquid accommodating part to the extraction medium holding | maintenance part, it was transferred to the said extraction medium holding | maintenance part, and the extract extracted from the test subject was hold | maintained At least a part of the extraction medium is transferred from the extraction medium holding unit to the reaction unit.

JP 2005-246054 A

According to the biological component analyzer according to Japanese Patent Application No. 2008-91599, the concentration of the extract can be prevented from becoming nonuniform by preventing the extraction medium from being mixed, but it is formed on the extraction cartridge made of synthetic resin. Since the extraction medium is held in the liquid storage portion including the recessed portion, if the extraction cartridge is left for a long period of time, the extraction medium may evaporate or leak from the liquid storage portion. . If the extraction medium is reduced below a predetermined amount due to evaporation or the like, the measurement accuracy is lowered.
Further, when the extraction medium evaporated or leaked from the liquid storage part reaches the reaction part, the reaction part deteriorates, and there is a possibility that the measurement accuracy is lowered due to the deterioration.

  The present invention has been made in view of such circumstances, and a biological component analyzer capable of preventing evaporation and leakage of an extraction medium from a liquid storage unit and maintaining good measurement accuracy, and the apparatus. It is an object of the present invention to provide an extraction cartridge and an extraction medium container used in the above.

The biological component analyzer according to the first aspect of the present invention is capable of contacting an examinee's skin and holding an extraction medium that can hold an extract medium for holding an extract extracted from the subject's skin. And
A reaction part for causing a predetermined reaction by the extract;
A detection unit for detecting the extract based on a predetermined reaction occurring in the reaction unit;
An extraction medium accommodating section capable of accommodating the extraction medium;
The extraction medium accommodated in the extraction medium accommodating unit is transferred to the extraction medium holding unit, and at least a part of the extraction medium that is transferred to the extraction medium holding unit and holds the extract extracted from the subject is An extraction medium transfer section for transferring from the extraction medium holding section to the reaction section;
And an analysis unit for analyzing a detection result by the detection unit, wherein the extraction medium storage unit is made of a metal thin film container.

In the biological component analyzer according to the first aspect of the present invention, the extraction medium storage portion for storing the extraction medium is made of a metal thin film container having a low liquid permeability compared to the synthetic resin, and thus stored for a long period of time. Even in this case, evaporation or leakage of the extraction medium accommodated in the container can be suppressed. Thereby, it can prevent that an extraction medium reduces, and can prevent the fall of the measurement precision resulting from the reduction | decrease of the said extraction medium. Moreover, since the reaction part is not deteriorated by the evaporated or leaked extraction medium, good measurement accuracy can be maintained.
Here, the predetermined amount of the extraction medium held in the extraction medium holding unit is preferably set to an amount substantially equal to the capacity of the extraction medium holding unit capable of holding the extraction medium in order to improve analysis accuracy.

  An extraction cartridge according to a second aspect of the present invention can be used in the biological component analyzer according to the first aspect, and includes the extraction medium storage unit and the extraction medium holding unit.

  An extraction medium container according to the third aspect of the present invention includes a container for containing an extraction medium for holding an extract extracted from the skin of a subject, and the container is made of a metal thin film. It is characterized by having.

  According to the biological component analyzer of the present invention, the extraction cartridge used in the apparatus, and the extraction medium container, it is possible to prevent evaporation and leakage of the extraction medium from the liquid container and maintain good measurement accuracy. it can.

Hereinafter, embodiments of a biological component analyzer of the present invention, an extraction cartridge used in the apparatus, and an extraction medium container will be described in detail with reference to the accompanying drawings.
First, the whole structure of the blood glucose level estimation apparatus 100 as one embodiment of the biological component analyzer of the present invention will be described.

[Overall configuration of blood sugar level estimation device]
FIG. 1 is a perspective view showing a blood sugar level estimating device 100 as an embodiment of the biological component analyzer of the present invention, and FIG. 2 is a diagram showing the blood sugar level estimating device 100 shown in FIG. 3 is a perspective view showing a state, and FIG. 3 is a perspective view showing a state in which the analysis unit of the blood glucose level estimation apparatus 100 shown in FIG. 1 is attached to the arm of the subject in the state of FIG. FIG. 4 is a schematic explanatory diagram for explaining the configuration of the apparatus main body of the blood glucose level estimation apparatus 100 shown in FIG. Note that in FIG. 4, for the sake of easy understanding, some elements that are actually arranged so as to be overlapped in the paper penetrating direction are arranged side by side in the horizontal direction of the paper.

  The blood glucose level estimation device 100 according to the present embodiment is a device that extracts glucose, which is one of biochemical components, from a living body and estimates the blood glucose level by analyzing the extracted glucose. As shown in FIGS. 1 and 2, the blood sugar level estimating apparatus 100 includes an analysis unit 1 and an extraction cartridge 50 (see FIG. 2). The analysis unit 1 includes an apparatus main body 10 that detachably holds the extraction cartridge 50, a holding member 20 that holds the apparatus main body 10 so as to be rotatable in the directions of arrows A and B, and the holding member 20 that is an arm of a subject. 110 (see FIG. 3).

  As shown in FIGS. 1 to 3, the apparatus main body 10 of the analysis unit 1 includes a display unit 11 (see FIG. 1) and operation buttons 12 (see FIG. 1) arranged on the surface side, and a state in use (apparatus). In the state where the main body 10 is closed), the release button 13 disposed on the end side in the arrow X1 direction, the extraction cartridge mounting portion 14 (see FIGS. 2 and 3) and the engagement hole 15 ( 2 and FIG. 3), a power source 16 (see FIG. 4) that functions as a DC constant voltage power source disposed inside, and also functions as an AC high frequency power source, and glucose by the detection unit 40 described later. The control part 17 as an analysis part which estimates (analyzes) a glucose level and a blood glucose level based on the detection result of this, and the pump 18 as an extraction medium transfer part which blows the air for transferring an extraction medium That.

  The display unit 11 of the apparatus main body 10 is provided to display the amount of glucose calculated by the control unit 17 and / or the estimated blood sugar level. The operation button 12 of the apparatus main body 10 is provided for the subject to operate the blood glucose level estimation apparatus 100 such as start of measurement. The release button 13 of the apparatus main body 10 is provided to release the engagement between an engagement portion 21e of the holding member 20 described later and an engagement hole 15 (see FIGS. 2 and 3) of the apparatus main body 10. .

  As shown in FIGS. 2 and 3, the extraction cartridge mounting portion 14 of the apparatus main body 10 includes a pair of rib-shaped protrusions 14a that function as a guide when mounting the extraction cartridge 50, and the extraction cartridge 50 (see FIG. 2). ) Are configured, a terminal portion 14c (see FIG. 3) connected to the power source 16 (see FIG. 4) of the apparatus main body 10, and a detection unit 40 (see FIG. 4). The light source part 41 and the light-receiving part 42, and the ejection part 14d which ejects the air ventilated from the pump 18 to the outer side of the extraction cartridge attachment part 14 are included. Further, the four engaging portions 14b of the extraction cartridge mounting portion 14 are configured to be elastically deformable so that the extraction cartridge 50 (see FIG. 2) can be attached and detached. The ejection portion 14d has a hemispherical shape and is urged so as to protrude outward from the extraction cartridge mounting portion 14 by a spring member (not shown). Further, the extraction cartridge mounting portion 14 is formed with a convex portion 5 for pressing an extraction medium accommodating portion (container) described later and supplying the extraction medium in the extraction medium accommodating portion to the liquid reservoir.

The engagement hole 15 of the apparatus main body 10 is provided to engage with the engagement portion 21e of the holding member 20 when the apparatus main body 10 is in a closed state with respect to the holding member 20 (see FIG. 1). .
2 and 3, the holding member 20 includes a holding member main body 21 that rotatably holds the apparatus main body 10, an engagement member 22 that constitutes a ratchet mechanism, and a holding member main body. 21 and a cover member 23 that covers one end side (the end side in the direction of the arrow Y1).

  In addition, the holding member main body 21 of the holding member 20 includes an opening 21a, four relief portions 21b, stepped portions 21c and 21d provided in the vicinity of the central portion in plan view, and an end portion in the arrow X1 direction. And an engaging portion 21e provided. The holding member main body 21 is made of synthetic resin such as ABS, and the lower surface 21f of the holding member main body 21 is formed in an arc shape when viewed from the X2 direction. Thereby, when the holding member 20 is attached to the subject's arm 110, it is possible to improve the adhesion with the subject's arm 110.

  Further, the opening 21a of the holding member main body 21 is formed in a square shape when seen in a plan view. Further, as shown in FIG. 3, the opening 21 a has a function of defining the measurement target region 110 a of the subject's arm 110 when the holding member 20 is attached to the subject's arm 110 by the attachment member 30. ing. At this time, the measurement target region 110a of the arm 110 of the subject protrudes in the arrow Z2 direction through the opening 21a.

  The four escape portions 21b of the holding member main body 21 are four engaging portions 14b (FIG. 2 and FIG. 2) of the apparatus main body 10 when the apparatus main body 10 is closed with respect to the holding member 20 (see FIG. 1). (See FIG. 3). The stepped portion 21c of the holding member main body 21 is provided with the extraction cartridge mounting portion 14 (see FIGS. 2 and 3) of the apparatus main body 10 when the apparatus main body 10 is closed with respect to the holding member 20 (see FIG. 1). It is provided for accommodation. Further, as shown in FIG. 2, a pair of engaging protrusions 21 g are formed on the step portion 21 d of the holding member main body portion 21. Further, the step portion 21d and the engagement protrusion 21g have a function of positioning when using a micro hole forming device 120 described later.

  The engaging portion 21e (see FIGS. 2 and 3) of the holding member main body 21 has an engagement hole 15 (see FIG. 1) when the apparatus main body 10 is closed with respect to the holding member 20 (see FIG. 1). 2 and FIG. 3), the device main body 10 has a function of restricting rotation of the apparatus main body 10 in the A direction (opening direction) with respect to the holding member main body 21. At this time, when the extraction cartridge 50 (see FIG. 2) is attached to the apparatus main body 10, the extraction cartridge 50 is exposed from the opening 21a of the holding member main body 21 as shown in FIG. The surface of the subject's arm 110 is contacted.

  Further, a sheet (not shown) made of a conductive material electrically connected to the power source 16 is attached to the lower surface portion 21 f of the holding member main body portion 21. Thereby, the holding member main-body part 21 is comprised so that it may function as an electrode.

  The engaging member 22 is made of a synthetic resin such as polyacetal and includes a pressing portion 22a. The engaging member 22 constitutes a ratchet mechanism that regulates the moving direction of the mounting member 30 relative to the holding member 20 in one direction (the direction of the arrow Z2). Further, the engaging member 22 has a release function for releasing the restriction of the ratchet mechanism, and is configured such that the restriction of the ratchet mechanism is released with respect to the mounting member 30 when the pressing portion 22a is pressed. Has been. On the other hand, when the pressing of the pressing portion 22a is released, the mounting member 30 is configured to be regulated by the ratchet mechanism.

  The cover member 23 of the holding member 20 includes a pair of passage holes 23 a through which the mounting member 30 passes and a hole portion 23 b in which the pressing portion 22 a of the engagement member 22 is disposed. The cover member 23 is made of a synthetic resin such as ABS, and is attached to the holding member main body 21 with screws 81.

  As shown in FIGS. 1 and 2, the mounting member 30 includes a connecting portion 31 and two sandwiching portions 32 extending from the lower end portion (the end portion on the arrow Z1 direction side) of the connecting portion 31 in the arrow Y2 direction. Is included. The mounting member 30 is made of a synthetic resin (rigid body) such as ABS. Further, a sheet (not shown) made of a conductive material electrically connected to the power source 16 is provided on the inner surface of the mounting member 30, similarly to the sheet affixed to the lower surface portion 21 f of the holding member main body portion 21. It is pasted. Thereby, the mounting member 30 is configured to function as an electrode.

  Further, the connecting portion 31 of the mounting member 30 includes a pair of engaging regions 31b having a plurality of engaging claws 31a, a retaining engaging groove 31c, and a protruding portion 31d protruding in the arrow Y2 direction. . The connecting portion 31 is configured to be able to change the distance between the sandwiching portion 32 and the holding member 20. Further, the plurality of engaging claws 31a allow the mounting member 30 to move in the arrow Z2 direction (upward) with respect to the holding member 20, and the mounting member 30 in the arrow Z1 direction (with respect to the holding member 20). It is configured to restrict movement in the downward direction. Further, the retaining engagement groove 31c is provided to prevent the mounting member 30 from falling off the holding member 20 when the connecting portion 31 is slid in the arrow Z1 direction. The protrusion 31d protruding in the arrow Y2 direction is provided with a through hole 311d extending in the arrow X1 direction and the arrow X2 direction.

  The sandwiching portion 32 of the mounting member 30 is formed in a curved plate shape as viewed from the direction of the arrow X2, and is configured to be elastically deformable. In addition, the pinching portion 32 is configured so that the distance between the pinching portion 32 and the holding member 20 is changed by the connecting portion 31, so that the arm 110 (see FIG. 3) of the subject is held between the holding member 20 and the vertical direction. It is comprised so that it can pinch | interpose. The sandwiching portion 32 is provided with two protrusions 32a at the end on the arrow Y1 direction side. The two protrusions 32a are formed with through holes (not shown) extending in the directions of the arrows X1 and X2, respectively. These through holes are formed so as to be coaxial with the through hole 311d of the connecting part 31, and a stainless steel shaft member 33 is inserted into the through hole 311d of the connecting part 31 and the through hole of the protruding part 32a. ing. As a result, the pinching portion 32 can be rotated around the shaft member 33 with respect to the connecting portion 31, and the pinching portion 32 can be folded to the connecting portion 31 side.

[Extraction cartridge]
Next, the extraction cartridge 50 will be described.
5 is a plan view when the extraction cartridge 50 of the blood glucose level estimation apparatus 100 shown in FIG. 1 is viewed from above, and FIG. 6 is a view when the extraction cartridge 50 shown in FIG. 5 is viewed from below. It is a top view. 7 is a cross-sectional view taken along line AA in FIG. 5, and FIG. 8 is a cross-sectional view taken along line BB in FIG.

  As shown in FIGS. 4 to 5, the extraction cartridge 50 in the present embodiment functions as an extraction medium for holding a cartridge body 51 made of a synthetic resin such as acrylic and glucose extracted from the arm 110 of the subject. A container 52 that is an extraction medium storage unit that stores pure water to be stored, an extraction medium holding unit 53 that can hold a predetermined amount of pure water for holding glucose extracted from the arm 110 of the subject, and glucose A reaction section 54 that causes a predetermined reaction, an air inlet 55 into which air ejected from the ejection section 14d flows, and a liquid reservoir section 6 that temporarily stores pure water supplied from the container 52. Contains. The said container 52 is arrange | positioned in the 4th recessed part 51d as a container installation part arrange | positioned adjacent to the said liquid reservoir part 6. As shown in FIG. 5 to 6, reference numeral 59 denotes a long hole for passing wiring from the apparatus main body 10 to electrodes 63 and 64 described later.

  As shown in FIGS. 4 and 6, a first recess 51 a having a rectangular opening 511 a is formed in the substantially central portion of the lower surface of the cartridge body 51. The extraction medium holding unit 53 is configured by the first recess 51a. The rectangular opening 511a is formed to extend in the directions of the arrows Y1 and Y2. On the first bottom surface 512a in the first recess 51a, a plurality of cylindrical intrusion prevention portions 513a extending in the outer direction (the direction of the arrow Z1) are formed. Further, the intrusion prevention part 513a is formed so that its height is substantially the same as the depth of the first recess 51a. For this reason, the front end surface of the intrusion prevention unit 513 a is located on the same plane as the lower surface of the cartridge body 51. Further, the plurality of intrusion prevention portions 513a are arranged in a line at predetermined intervals in the directions of the arrows Y1 and Y2 over the entire area of the opening 511a. Thereby, it is possible to prevent the surface of the arm 110 of the subject from entering the extraction medium holding unit 53. Further, the extraction medium holding part 53 has a volume capable of holding a predetermined amount (for example, about 5 μl to about 6 μl) of liquid.

  As shown in FIG. 5, the second surface of the cartridge body 51 overlaps with the vicinity of the end portion on the arrow Y1 direction side of the extraction medium holding portion 53 (first concave portion 51a) in plan view. A recess 51b is formed. The liquid reservoir 6 is configured by the second recess 51b. Further, as shown in FIG. 4, the second bottom surface 511b of the second recess 51b is disposed on the upper side (arrow Z2 direction side) of the first bottom surface 512a of the first recess 51a. That is, the liquid reservoir 6 and the extraction medium holding unit 53 are arranged so as not to overlap in the height direction (the directions of the arrows Z1 and Z2). Further, a first flow path 56 penetrating to the first bottom surface 512a of the first recess 51a is formed in a portion of the second bottom surface 511b where the liquid reservoir 6 and the extraction medium holding unit 53 overlap when viewed in plan. Yes. Accordingly, the liquid reservoir 6 and the extraction medium holding unit 53 are spatially connected via the first flow path 56. In addition, the liquid reservoir 6 has a volume capable of accommodating a liquid of substantially the same amount (for example, about 5 μl to about 6 μl) that can be held by the extraction medium holding unit 53.

  Further, as shown in FIGS. 4 and 5, the upper surface of the cartridge body 51 extends from the second recess 51b by a predetermined distance in the arrow Z1 direction, then extends by a predetermined distance in the arrow X2 direction, and further in the arrow Y1 direction. A second flow path 57 extending a predetermined distance and finally extending a predetermined distance in the arrow Z2 direction is formed. An opening in the upper surface of the cartridge main body 51 of the second flow path 57 is a pump connection port 55.

  The pump connection port 55 has a circular shape when seen in a plan view. The diameter of the pump connection port 55 is set to be smaller than the diameter of the ejection portion 14d having a hemispherical shape. Thereby, in a state where the extraction cartridge 50 is attached to the extraction cartridge attachment portion 14, the pump connection port 55 can be blocked by the outer surface of the ejection portion 14d. At this time, since the ejection portion 14 is urged toward the outside of the extraction cartridge mounting portion 14 by a spring member (not shown), a predetermined urging force is applied to the outer surface of the ejection portion 14d and the edge of the pump connection port 55. In contact with each other. Thereby, it can suppress that the air which ejects from the ejection part 14d leaks from the pump connection port 55. FIG.

  Further, as shown in FIG. 5, the upper surface of the cartridge main body 51 has a third recess so as to overlap with the end of the extraction medium holding portion 53 (first recess 51a) on the arrow Y2 direction side in plan view. 51c is formed in a rectangular shape. As shown in FIG. 4, the third bottom surface 511c of the third recess 51c is disposed on the upper side (arrow Z2 direction side) of the first bottom surface 512a of the first recess 51a. That is, the third concave portion 51d and the extraction medium holding portion 53 are arranged so as not to overlap in the height direction (arrow Z1 and arrow Z2 directions). Further, a third flow path 58 penetrating to the first bottom surface 512a of the first recess 51a is formed in a portion of the third bottom surface 511c where the third recess 51c and the extraction medium holding portion 53 overlap in plan view. Yes. Further, as shown in FIG. 5, a groove 61 extending from the third recess 51c to the end of the cartridge body 51 on the arrow Y2 direction side is formed in the center part of the cartridge body 51 on the arrow X1 and arrow X2 direction sides. Has been. Further, the groove 61 is formed so that the depth thereof is substantially the same as the depth of the third recess 51c.

  In the present embodiment, as shown in FIG. 5, the third bottom surface 511 c of the third recess 51 c has a rectangular shape so as to surround substantially the center of the third bottom surface 511 c in a plan view. Two shading tapes 71 and 72 having a predetermined height are arranged. Specifically, one light shielding tape 71 has a rectangular shape, and the other light shielding tape 72 has an L shape. In addition, one light shielding tape 71 is arranged on the arrow X1 direction side with respect to the other light shielding tape 72 and at a position separated from the inner side surface of the third recess 51c by a predetermined distance. The other light-shielding tape 72 having an L shape is disposed on the side of the arrow X2 with respect to the one light-shielding tape 71 and at a position separated from the inner side surface of the third recess 51c by a predetermined distance. Further, the portion 72 a extending in the direction of the arrow X <b> 1 of the light shielding tape 72 having an L shape is formed so that the tip end portion thereof is disposed at a position separated from the one light shielding tape 71 by a predetermined distance. The light shielding tapes 71 and 72 have a function of shielding light when the detection unit 40 detects glucose.

  A sensor member 80 described later is disposed on the upper surfaces of the light shielding tapes 71 and 72. The sensor member 80 has a rectangular shape that is substantially the same size as the third recess 51c in plan view, and is fitted into the third recess 51c so as to close the opening of the third recess 51c. . Further, since the light shielding tapes 71 and 72 function as spacers, the sensor member 80 is disposed at a position separated from the third bottom surface 511c of the third recess 51c by a predetermined distance (approximately the distance corresponding to the height of the light shielding tape). Yes. Here, the reaction portion 54 is surrounded by the light shielding tapes 71 and 72, the third bottom surface 511c of the third recess portion 51c, and the lower surface 80a of the sensor member 80 at a substantially central portion of the third recess portion 51c as viewed in a plan view. It is constituted by being. Further, in the third recess 51c, other than the reaction portion 54 surrounded by the inner surface of the third recess 51c, the light shielding tapes 71 and 72, the bottom surface 511c of the third recess 51c, and the lower surface 80a of the sensor member 80. The part functions as a flow path for venting the reaction part 54 and allowing the excess liquid to escape to the groove part 61. The reaction unit 54 is configured to be able to hold an amount of liquid (for example, about 2.5 μl to about 3 μl) smaller than a predetermined amount that can be held by the extraction medium holding unit 53. Further, a mesh sheet 62 having almost the same height as the light shielding tapes 71 and 72 is disposed in the reaction portion 54 over the entire reaction portion 54. Thereby, since the liquid transferred to the reaction unit 54 is absorbed by the mesh sheet 62, it is possible to reliably hold a certain amount or more of liquid in the reaction unit 54 and to be transferred into the reaction unit 54. The liquid can be easily brought into contact with the lower surface 80a of the sensor member 80.

  As shown in FIG. 6, the first electrode 63 and the second electrode 64 are attached to the lower surface of the cartridge body 51 in the direction of the arrow X1 and the direction of the arrow X2 of the opening 511a, respectively. Further, in a state where the extraction cartridge 50 is attached to the extraction cartridge attachment portion 14 of the apparatus main body 10, the first electrode 63 and the second electrode 64 are in contact with the terminal portion 14 c and the terminal portion 14 c of the extraction cartridge attachment portion 14. The extraction cartridge 50 is electrically connected to the power source 16 of the apparatus main body 10 via the terminal portion 51e. The first electrode 63 is disposed so as to extend from the end portion on the arrow Y1 direction side of the opening 511a to the vicinity of the end portion on the arrow Y2 direction side. Further, the second electrode 64 is disposed so as to extend by a minute distance in the arrow Y1 direction from the end of the opening 511a on the arrow Y2 direction side so as not to contact the first electrode 63. That is, the first electrode 63 and the second electrode 64 are arranged so as to be separated in the vicinity of the end portion on the arrow Y2 direction side of the opening 511a. The first electrode 63 and the second electrode 64 are actually arranged at positions that do not appear in FIG. 4, but here, for convenience of explanation, the first electrode 63 and the second electrode are shown in FIG. 64 is described.

  A double-sided tape 65 is attached to the lower surface of the cartridge main body 51 in a region other than the opening 511 a of the extraction medium holding unit 53. As a result, the cartridge body 51 can be brought into close contact with the arm 110 of the subject. As shown in FIGS. 4 and 5, a tape 66 is attached to the upper surface of the cartridge body 51 so as to close the second recess 51 b opened on the upper surface side of the cartridge body 51.

Further, a mixed gel containing a coloring dye that develops color due to the reaction of glucose and a predetermined enzyme is applied to a portion exposed in the reaction portion 54 of the lower surface 80a of the sensor member 80. A treatment for drying the gel is performed. Specifically, on the lower surface 80a of the sensor member 80, glucose oxidase (GOD), which is an oxidase as a catalyst for glucose, and hydrogen peroxide (H ₂ O generated by the reaction of glucose with GOD as a catalyst). ₂ ) Gels of peroxidase (POD), which is an oxidoreductase as a catalyst for ₂ ), and a coloring dye that develops color by reacting with O ^* (active oxygen) produced by reaction of H ₂ O ₂ with POD as a catalyst. The mixed gel mixed with is applied, and the mixed gel is dried.

[Extraction medium container]
FIG. 9 is an explanatory plan view of the container 52 disposed in the fourth recess 51d constituting the container installation portion. The container 52 has a cylindrical shape provided with a container main body 52a formed of an aluminum thin film having a thickness of about 0.1 mm and a discharge port 52b through which pure water (extraction medium) accommodated in the container main body 52a is discharged. And the mouth portion 52c.

The container body 52a has two rectangular aluminum thin films having a short side of about 3 to 4 mm and a long side of about 4 to 5 mm, and a synthetic resin thin film is interposed in the peripheral region 52d to heat each other by heat sealing. It is fixed.
The mouth portion 52c is made of a synthetic resin such as ABS or a metal such as brass, and is formed of a cylinder having an outer diameter of about 1 to 1.5 mm and an inner diameter of about 0.5 to 1.0 mm. The peripheral region 52d is heat-sealed in a state where the mouth portion 52c is disposed between two aluminum thin films constituting the container body 52a, whereby the mouth portion 52c is fixed to the container body 52a.

An easy peel 7 is provided in the vicinity of the container inner side end of the mouth portion 52c as a sealing means for blocking between the inside of the container and the passage 52e of the mouth portion 52c. The easy peel 7 is formed by heat sealing in the same manner as the peripheral region 52d of the container body 52a. The degree of adhesion (strength) of the easy peel 7 is determined by a predetermined method for the bulging portion of the container body 52a filled with pure water. It is set so that it can be torn by pressing. Specifically, the easy peel 7 having a desired fixing strength can be obtained by appropriately selecting the type of hot melt adhesive used for heat sealing and the width of the belt-shaped heat sealing region.
As shown in FIG. 8, the container 52 has the container body 52 located in the fourth recess 51d and the mouth 52c located in the communication path 60 that communicates the second recess 51b and the fourth recess 51d. It is arranged as follows.

  As the sealing means, a synthetic resin film such as a nylon film having a thickness of about 0.03 mm can be adopted instead of the easy peel 7, and this film is either one of both end faces of the cylindrical mouth portion 52c. It is fixed to the end face.

[Device usage procedure]
FIG. 10 is a flowchart for explaining a procedure when the subject uses the blood sugar level estimating device, and FIG. 11 is a diagram for explaining a procedure for using the blood sugar level estimating device shown in FIG.

  First, in step S1, as shown in FIG. 11, the blood glucose level estimating apparatus 100 is placed on the subject's arm 110 so that the subject's arm 110 is sandwiched between the holding member 20 and the sandwiching portion 32 of the mounting member 30. Installing. Thereby, the measurement target region 110 a is defined by the opening 21 a of the holding member 20. In step S <b> 2, using the micropore forming device 120, micropores (extraction holes) 111 (see FIG. 12) are formed in the measurement target region 110 a defined by the opening 21 a of the subject's arm 110. Specifically, after fitting the guide portion 122 of the micropore forming device 120 into the stepped portion 21 d of the holding member main body portion 21, the subject presses the button portion 121, thereby causing the micropore forming device 120 to move from the inside. A fine needle (not shown) protrudes. Thereby, a fine hole (extraction hole) 111 (see FIG. 12) is formed in the measurement target region 110a defined in the opening 21a of the arm 110 of the subject. At that time, as shown in FIG. 12, a minute hole (extraction hole) 111 that penetrates the epidermis and reaches the dermis but does not reach the subcutaneous tissue is formed in the arm 110 of the subject. It becomes possible to extract body fluid from the arm 110 of the subject through the plurality of fine holes (extraction holes) 111. Thereby, when extracting glucose from a test subject's arm 110 using the blood glucose level estimation apparatus 100, it is possible to reduce the pain which a test subject feels. Thereafter, the micropore forming device 120 is removed from the holding member main body 21.

  Next, in step S <b> 3, the extraction cartridge 50 is attached to the extraction cartridge attachment portion 14 of the apparatus main body 10. Specifically, as shown in FIG. 13, a film 90 is attached to an unused extraction cartridge 50 so as to cover almost the entire upper and lower surfaces of the cartridge body 51. All the openings exposed on the lower surface are blocked by the film 90. Thereby, impurities are prevented from adhering to each part provided in the cartridge main body 51. In this state, the subject peels the film 90 from the cartridge main body 51 by pulling the end of the film 90 arranged on the lower surface side of the cartridge main body 51 in the direction of arrow Y1 in the direction of arrow Y2. Each part inside the cartridge main body 51 is filled with air (gas). Then, the subject attaches the extraction cartridge 50 to the extraction cartridge attachment portion 14 of the apparatus main body 10.

When the extraction cartridge 50 is attached to the extraction cartridge attachment portion 14 of the apparatus main body 10, the bulge portion of the container 52 is pressed by the convex portion 5 formed on the extraction cartridge attachment portion 14 so as to correspond to the position of the container 52. . As a result, the easy peel 7 of the container 52 is broken and the pure water inside the container 52 is discharged to the liquid reservoir 6.
Thereafter, the apparatus main body 10 is rotated in the B direction to close the apparatus main body 10, and the measurement is started by operating the operation button 12.

[Measurement processing]
FIG. 14 is a flowchart for explaining measurement processing by the control unit of the blood sugar level estimating apparatus shown in FIG. FIGS. 15-20 is a figure for demonstrating the measurement process by the control part of the blood glucose level estimation apparatus shown by FIG. Next, measurement processing by the control unit 17 of the blood glucose level estimation apparatus 100 according to the present embodiment will be described with reference to FIGS.

  As shown in FIGS. 15 and 16, immediately after the measurement is started, a predetermined amount (for example, about 5 μl to about 6 μl) of pure water (liquid) supplied from the container 52 is accommodated in the liquid reservoir 6. ing. In step S11, air blown from the pump 18 is ejected from the ejection portion 14d to the air inflow portion 55. As a result, the air present in the second flow path 57 is transferred to the liquid reservoir 6, so that the pure water stored in the liquid reservoir 6 is pushed out to the air flowing in from the second flow path 57. As described above, it is transferred to the extraction medium holding unit 53 via the first flow path 56. In step S <b> 12, the controller 17 performs an operation for confirming the completion of the transfer of pure water from the liquid reservoir 6 to the extraction medium holder 53. Specifically, a high frequency voltage is applied to the first electrode 63 and the second electrode 64 by the power supply 16, and a change in impedance between the first electrode 63 and the second electrode 64 is detected by the control unit 17. . That is, pure water flowing into the extraction medium holding part 53 from the first flow path 56 arranged on the arrow Y1 direction side of the extraction medium holding part 53 is near the end of the extraction medium holding part 53 on the arrow Y2 direction side. When a certain distance between the first electrode 63 and the second electrode 64 is reached, the impedance between the first electrode 63 and the second electrode 64 decreases, and the controller 17 detects the decrease. Thereby, it is possible to confirm that pure water has been transferred to almost the entire area of the extraction medium holding unit 53.

  In step S13, whether or not the transfer of pure water from the liquid reservoir 6 to the extraction medium holding unit 53 is completed based on the detection result of the change in impedance between the first electrode 63 and the second electrode 64. Is judged. In this determination, when the impedance between the first electrode 63 and the second electrode 64 falls below a predetermined threshold, it is determined that the transfer of pure water from the liquid reservoir 6 to the extraction medium holding unit 53 is completed. The controller 17 may be configured as described above, and when the amount of decrease in impedance within a predetermined time exceeds the threshold, it is determined that the transfer of pure water from the liquid reservoir 6 to the extraction medium holding unit 53 is completed. The control unit 17 may be configured as described above. If the transfer is not completed even after the predetermined time has elapsed, it is handled as an error in step S19, and the operation of the measurement process is ended as it is.

  On the other hand, when the controller 17 determines that the transfer of pure water has been completed, the blowing of air by the pump 18 is stopped, and the transfer of pure water is stopped. At that time, as shown in FIGS. 17 and 18, a predetermined amount (for example, about 5 μl to about 6 μl) of pure water is present only in the extraction medium holding unit 53 (that is, in FIGS. 17 and 18). The region where pure water is present is the extraction medium holding unit 53). Then, in step S14, glucose is retained from the subject's arm 110 (micropore 111) for a predetermined time while holding pure water in the extraction medium holding portion 53 in which the opening 511a is blocked by the surface of the subject's arm 110. Extracted. Specifically, based on the control of the control unit 17, the first electrode 63 and the second electrode 64 are negative by the power source 16, and the sheet made of a conductive material attached to the inner surface of the mounting member 30 is the positive electrode. To supply a constant current. As a result, glucose in the body of the subject is easily moved toward the first electrode 63 and the second electrode 64 to which a negative voltage is applied, so that the subject's arm 110 (fine) is added to the pure water in the extraction medium holding unit 53. Glucose can be extracted smoothly from the hole 111). Then, after a predetermined time has elapsed, the supply of constant current to the first electrode 63 and the second electrode 64 by the power source 16 and the sheet made of the conductive material of the mounting member 30 is stopped, and glucose extraction is completed. The power source 16 may supply a direct current, an alternating current, or a mixed current of direct current and alternating current. The power supply 16 may be a constant voltage power supply that applies a constant voltage.

  Thereafter, in step S15, air blowing by the pump 18 is resumed. As a result, the air present in the second flow path 57, the liquid reservoir 6 and the first flow path 56 is transferred to the extraction medium holding part 53 side, so that the inside of the extraction medium holding part 53 for holding the extracted glucose is transferred. The third flow path is such that a part (for example, about 2.5 μl to about 3 μl) of pure water (hereinafter, this liquid is referred to as a glucose holding liquid) is pushed out to the air flowing from the first flow path 56. 58 to the reaction section 54 (see FIGS. 19 and 20). Then, the glucose retentate transferred to the reaction unit 54 is absorbed in the mesh sheet 62 installed in the reaction unit 54, thereby being held in the reaction unit 54 and applied to the lower surface 80 a of the sensor member 80. Contacted with the mixed gel. Further, the air present in the reaction part 54 before the glucose holding liquid is transferred is released to the outside of the extraction cartridge 50 through the groove part 61 as the glucose holding liquid is transferred. Moreover, the excess glucose holding liquid other than the glucose holding liquid transferred to the reaction unit 54 is released to a space (flow path) other than the reaction unit 54 in the third recess 51c.

  In step S16, glucose detection is started. Specifically, the control unit 17 uses the light source unit 41 and the light receiving unit 42 constituting the detection unit 40 (see FIG. 4) to determine the absorbance at which the light from the light source unit 41 is absorbed by the coloring dye of the sensor member 80. Monitor continuously for a predetermined time. After that, in step S17, the blood glucose level is calculated by the control unit 17 based on the absorbance when the absorbance is substantially saturated. In step S18, the calculated blood glucose level is displayed on the display unit 11, and the measurement processing operation by the control unit 17 ends.

  In addition, although the container 52 in embodiment mentioned above is provided with the cylindrical opening | mouth part separately from the container main body, as FIG. 21 shows, the container 152 can also be comprised only with a metal thin film. In this case, a part of the peripheral edge of the container 152 is a discharge port 152a, and an easy peel 107 as a sealing means is provided in the vicinity of the discharge port 152a. In the aspect shown in FIG. 21, the container installation part (fourth recessed part 51d) and the convex part 5 of the apparatus main body 10 as in the above-described embodiment can be omitted. That is, the container 152 is disposed at a predetermined position on the flat surface of the cartridge main body 51, the extraction cartridge 50 is mounted on the apparatus main body 10 in this state, and the container 152 is sandwiched between the apparatus main body 10 and the cartridge main body 51. Pressure can be applied inside the container. Then, the easy peel 107 can be broken by this pressure, and the extraction medium inside the container can be discharged into the liquid reservoir 6. In this case, in order to facilitate the movement of the extraction medium from the apparatus main body 10 to the liquid reservoir 6, the discharge port 152 a is lengthened and the tip portion thereof is disposed in the liquid reservoir 6, and the discharge port 152 a A recess having a semicircular cross section can be formed on the surface of the cartridge body 51 at the portion to be disposed.

  In the above-described embodiment, the extraction medium holding unit, the reaction unit, and the detection unit are set at different locations, but they can be set at the same location. That is, the extract extracted at the same place can be measured while extracting the extract from the subject using the extraction medium.

  In the above-described embodiment, a metal thin film such as aluminum is used as a material constituting the containers 52 and 152. Instead of the metal thin film, for example, a polytetrafluoroethylene-based synthetic resin having a relatively high moisture resistance. It is also possible to use.

  Furthermore, in the biological component analyzer according to the above-described embodiment, an extraction medium holding unit that extracts an extract from a subject, and a detection unit that detects the extract based on a predetermined reaction caused by the extracted extract, However, the extraction cartridge and the extraction medium container of the present invention can also be applied when the extraction medium holding unit and the detection unit are provided in different apparatuses.

It is a perspective view which shows the blood glucose level estimation apparatus as one Embodiment of the biological component analyzer of this invention. It is a perspective view which shows the state which opened the apparatus main body of the blood glucose level estimation apparatus shown by FIG. It is a perspective view which shows the state which mounted | wore the test subject's arm with the analysis unit of the blood glucose level estimation apparatus shown by FIG. It is a schematic explanatory drawing explaining the structure of the apparatus main body of the blood glucose level estimation apparatus shown by FIG. It is a top view at the time of seeing the extraction cartridge of the blood glucose level estimation apparatus shown by FIG. 1 from the upper side. It is a top view at the time of seeing the extraction cartridge shown by FIG. 5 from the lower side. It is AA sectional view explanatory drawing of FIG. FIG. 6 is a cross-sectional explanatory view taken along line BB in FIG. 5. It is a plane explanatory view of the extraction medium storage part of the blood sugar level estimation device shown in FIG. It is a flowchart for demonstrating the procedure at the time of a test subject using a blood glucose level estimation apparatus. It is a figure for demonstrating the use procedure of the blood glucose level estimation apparatus shown by FIG. It is sectional drawing which shows the state of the skin in which the micropore was formed by the micropore formation apparatus shown by FIG. It is the schematic which shows the unused extraction cartridge used for the blood glucose level estimation apparatus shown by FIG. It is a flowchart for demonstrating the measurement process by the control part of the blood glucose level estimation apparatus shown by FIG. FIG. 2 is an explanatory plan view showing an extraction cartridge in a state where liquid is stored in a liquid storage unit in the blood sugar level estimation device shown in FIG. 1. FIG. 2 is a cross-sectional explanatory view showing an extraction cartridge in a state where liquid is stored in a liquid storage unit in the blood sugar level estimation device shown in FIG. 1. FIG. 2 is an explanatory plan view showing an extraction cartridge in a state where a liquid is held in an extraction medium holding unit in the blood sugar level estimation device shown in FIG. 1. FIG. 2 is an explanatory cross-sectional view showing an extraction cartridge in a state where a liquid is held in an extraction medium holding unit in the blood sugar level estimation device shown in FIG. FIG. 2 is an explanatory plan view showing an extraction cartridge in a state where liquid is held in a reaction part in the blood sugar level estimation device shown in FIG. 1. FIG. 2 is a cross-sectional explanatory view showing an extraction cartridge in a state where a liquid is held in a reaction part in the blood sugar level estimation device shown in FIG. 1. It is plane explanatory drawing of the other aspect of the extraction medium accommodating part of a blood glucose level estimation apparatus.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Analysis unit 5 Convex part 6 Liquid reservoir part 7 Easy peel 10 Apparatus main body 11 Display part 12 Operation button 13 Release button 14 Extraction cartridge attachment part 15 Engagement hole 16 Power supply 17 Control part 18 Pump 20 Holding member 21 Holding member main body part 22 Engagement member 23 Cover member 30 Mounting member 31 Connecting portion 32 Clipping portion 33 Shaft member 40 Detection portion 41 Light source portion 42 Light receiving portion 51 Cartridge body 52 Container (extraction medium storage portion)
53 Extraction medium holding unit 54 Reaction unit
56 1st flow path 57 2nd flow path 58 3rd flow path 59 Communication path 60 Long hole 80 Sensor member 90 Film 107 Easy peel 110 Arm 152 Container

Claims (13)

An extraction medium holding unit capable of contacting the subject's skin and holding an extraction medium for holding an extract extracted from the subject's skin;
A reaction part for causing a predetermined reaction by the extract;
A detection unit for detecting the extract based on a predetermined reaction occurring in the reaction unit;
An extraction medium accommodating section capable of accommodating the extraction medium;
The extraction medium accommodated in the extraction medium accommodating unit is transferred to the extraction medium holding unit, and at least a part of the extraction medium that is transferred to the extraction medium holding unit and holds the extract extracted from the subject is An extraction medium transfer section for transferring from the extraction medium holding section to the reaction section;
A biological component analyzer comprising: an analysis unit that analyzes a detection result of the detection unit, wherein the extraction medium storage unit is a container made of a metal thin film.   The biological component analyzer according to claim 1, wherein a sealing unit is provided in the vicinity of a discharge port from which the extraction medium is discharged from the container so that the sealing performance is released by pressing a metal thin film constituting the container.   The biological component analyzer according to claim 2, wherein the sealing means is formed by heat sealing of a synthetic resin thin film.   The biological component analyzer according to claim 1, wherein the metal thin film is made of aluminum.   The biological component analyzer includes a convex portion at a position corresponding to the extraction medium container when an extraction cartridge including the extraction medium container and the extraction medium holder is mounted on the biological component analyzer. The metal thin film container constituting the extraction medium accommodating portion is pressed by the convex portion to release the sealing by the sealing means, and the extraction medium is supplied to a predetermined position. The biological component analyzer according to 1.   An extraction cartridge that can be used in the biological component analyzer according to claim 1 and includes the extraction medium storage unit and the extraction medium holding unit.   The extraction cartridge according to claim 6, wherein sealing means is provided in the vicinity of a discharge port from which the extraction medium is discharged from the container so that the sealing performance is released by pressing a metal thin film constituting the container.   The extraction cartridge according to claim 7, wherein the sealing means is formed by heat sealing of a synthetic resin thin film.   The extraction cartridge according to claim 6 or 7, wherein the metal thin film is made of aluminum.   An extraction medium container comprising a container for storing an extraction medium for holding an extract extracted from the skin of a subject, and the container is made of a metal thin film.   The extraction medium container according to claim 10, wherein sealing means is provided in the vicinity of a discharge port from which the extraction medium is discharged from the container so that the sealing performance is released by pressing a metal thin film constituting the container.   The extraction medium container according to claim 11, wherein the sealing means is formed by heat sealing of a synthetic resin thin film.   The extraction medium container according to claim 10 or 11, wherein the metal thin film is made of aluminum.