JP2008082899A - Component measuring chip - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a component measuring chip capable of certainly guiding a very small amount of body fluids to test paper to rapidly and certainly develop the same on the test paper. <P>SOLUTION: The component measuring chip 4 includes a chip body 5 constituted of a plate-shaped member and demarcating a blood flow channel 50 through which blood passes, the test paper 6 installed in the chip body 5 to detect a predetermined component in the blood passed through the blood flow channel 50, the developing auxiliary member 7 installed adjacent to the test paper 6 to assisting the development of the blood passed through the blood flow channel 50 on the test paper 6 and a lid body 8 having a function for fixing the test paper 6 and the developing auxiliary member 7 to the chip body 5. The blood flow channel 50 is formed of the pipeline 54 formed in the chip body 5 and opened as a blood introducing port 541 at its leading end, the recess 55 opened on the side of the test paper 6 and more expanded in width than the inner diameter of the base end part 542 of the pipeline 54 and the groove part 56 opened to the bottom part 551 of the recess 55 to communicate with the base end part 542 of the pipeline 54 and the recess 55. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a component measuring chip.

  A blood glucose measurement device (blood component measurement device) that measures blood glucose levels is known. This blood glucose measurement device quantifies blood glucose levels by supplying and spreading blood on test paper that is colored according to the amount of glucose in the blood, and optically measuring (colorimetric) the degree of coloration on the test paper To do.

  In such a conventional blood glucose measuring device, a component measuring chip (body fluid collecting tool) is attached, and blood is collected from the component measuring chip. The collected blood is absorbed by the test paper installed on the component measuring chip. The color measurement of the test paper is performed by irradiating the test paper with light and measuring the intensity of the reflected light in a photometry unit including a light emitting element and a light receiving element.

  As a component measuring chip, for example, a chip described in Patent Document 1 is known. This component measuring chip has a base (base) and a cover that are plate-shaped, and a test paper installed on the base. The base has a groove provided on the surface opposite to the test paper, and a hole communicating with the groove and opening on the test paper side. In the component measuring chip, the surface of the base opposite to the test paper and one surface of the cover are joined. In the component measuring chip, the space defined by the inner peripheral surface of the groove and one surface of the cover and the hole are used as a blood flow path for guiding blood to the test paper.

  In this conventional component measuring chip, a gap occurs at the joint between the base and the cover. Some blood that passes through the space (blood flow path) may flow into this gap before it reaches the test paper. For this reason, blood sufficient for blood glucose measurement may not reach (develop) the test paper, that is, the test paper may not be colored enough for blood glucose measurement. In addition, since blood flows toward the test paper while flowing into the portion other than the blood flow path (gap) in this way, a relatively large amount of time is spent until the blood reaches the test paper, Rapid blood glucose measurement has been difficult.

International Publication No. 2004/084727 Pamphlet

  The objective of this invention is providing the chip | tip for a component measurement which can guide | invade a trace amount of bodily fluid reliably to a test paper, and can be developed to the said test paper rapidly and reliably.

  Such an object is achieved by the present inventions (1) to (17) below. Moreover, it is preferable that it is following (18)-(21).

(1) a first member that is configured by a plate-like body and that defines a body fluid passage through which body fluid passes;
A test paper installed on the first member for detecting a predetermined component in the body fluid that has passed through the body fluid flow path;
A deployment auxiliary member that is installed adjacent to the test paper and assists in spreading the body fluid that has passed through the body fluid flow path on the test paper;
A second member having a function of fixing the test paper and the development auxiliary member to the first member;
The bodily fluid channel is formed inside the first member, one end of which opens as a bodily fluid inlet for introducing bodily fluid, and the inner diameter of the other end of the tube that opens on the test paper side. A component measuring chip comprising: a recess having a wider width; and a groove opening at the bottom of the recess and communicating the other end of the conduit with the recess.

  (2) The component measuring chip according to (1), wherein a> b is satisfied, where a is an inner diameter of the conduit and b is a depth of the recess.

  (3) The above-described (1) or (1) or (2), wherein the conduit, the groove, and the recess are arranged substantially in a straight line along the flow direction of the body fluid introduced from the body fluid introduction port in this order in a side view. The component measuring chip according to (2).

  (4) The component measuring chip according to any one of (1) to (3), wherein an inner diameter of the one end portion of the conduit is gradually increased in a distal direction.

  (5) The component measurement chip according to any one of (1) to (4), wherein one end portion of the pipe line protrudes in a distal direction.

  (6) The component measurement chip according to any one of (1) to (5), wherein the groove is open at an edge of the bottom of the recess.

  (7) The component measurement chip according to any one of (1) to (6), wherein a width of the groove is equal to an inner diameter of the other end of the conduit.

  (8) The component measurement chip according to any one of (1) to (7), wherein the groove has a portion whose depth is continuously shallow at a base end portion thereof.

  (9) The component measuring chip according to any one of (1) to (8), wherein the concave portion has a substantially rectangular or square shape in plan view.

(10) The deployment assisting member is installed in the recess,
The said test paper is a chip | tip for a component measurement in any one of said (1) thru | or (9) currently laminated | stacked on the said expansion | deployment auxiliary member.

  (11) The component measuring chip according to any one of (1) to (10), wherein the deployment assisting member is configured by a sheet-like mesh member.

  (12) The expansion assisting member according to any one of (1) to (11), wherein the area of the development assisting member is smaller than that of the test paper in a plan view, and is positioned at a substantially central portion of the test paper in a plan view. Component measurement chip.

  (13) The component measurement chip according to any one of (1) to (12), wherein the deployment assisting member has a portion whose width gradually decreases in the distal direction.

  (14) The (1) to (1), wherein the first member communicates with the recess and defines an exhaust path for discharging air in the body fluid flow path when body fluid is introduced into the body fluid flow path. The component measuring chip according to any one of 13).

  (15) The component measurement chip according to any one of (1) to (14), wherein the second member includes a window portion for measuring the color of the colored test paper.

  (16) The component measuring chip according to any one of (1) to (15), further including a flow promoting unit that promotes a flow of body fluid from the groove to the recess.

  (17) The flow promoting means is provided in the second member, and includes a protrusion that protrudes toward the groove in the vicinity of the groove of the recess to suppress the test paper. Component measurement chip.

  (18) The chip for measuring a component according to any one of (1) to (17), wherein the groove is disposed on an extension line of the conduit.

  (19) The component measuring chip according to any one of (1) to (18), wherein the groove has a substantially U-shaped cross section.

  (20) The component measurement chip according to (10), wherein a maximum width of the deployment assisting member is substantially equal to a width of the recess.

  (21) The component measurement chip according to (15), wherein a diameter of the window and a width of the recess are substantially equal.

  According to the present invention, even if it is a trace amount sample, the bodily fluid surely passes through a channel, a groove, and a crevice in order. This ensures that the specimen is guided to the test paper. In addition, the specimen guided to the test paper can be quickly and reliably developed on the test paper.

  Further, when the inner diameter of the conduit is a and the depth of the recess is b, when a> b is satisfied, the specimen passing through the conduit is more reliably guided to the recess through the groove.

  Hereinafter, the component measuring chip of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a perspective view showing a first embodiment when the component measuring chip of the present invention is applied to a body fluid collecting tool in which a puncture needle is housed, and FIG. 2 is an exploded perspective view of the component measuring chip shown in FIG. 3 is a plan view of the component measuring chip shown in FIG. 1, FIG. 4 is a cross-sectional view taken along line AA in FIG. 3, and FIG. 5 is a body fluid collecting tool (component measuring chip) shown in FIG. FIG. 6 is a perspective view of a lid of the component measuring chip shown in FIG. 1. In the following, for convenience of explanation, the right side in FIGS. 1 to 5 (the same applies to FIGS. 7 to 10) is referred to as “base end”, and the left side is referred to as “tip”. 1, 2, 4, and 5 (the same applies to FIGS. 8 and 10 to 13), the upper side is referred to as “upper” or “upper”, and the lower side is referred to as “lower” or “lower”. To tell.

  A bodily fluid collecting tool 1 shown in FIG. 1 includes a collecting tool main body 2, a puncture needle 3 housed (installed) in the collecting tool main body 2, and a component measuring chip of the present invention installed in the collecting tool main body 2 ( (Hereinafter simply referred to as “chip”) 4.

  As shown in FIG. 5, the body fluid sampling tool 1 (chip 4) is used by being loaded into the component measuring device 100. As the component measuring apparatus 100, an apparatus that includes a puncturing means (a puncturing mechanism (not shown)) and that can measure a predetermined component in a body fluid collected through the epidermis (skin) will be described as a representative. In addition, the part of the epidermis involved in the collection of the body fluid (body fluid collection part) is preferably a finger, but in addition, for example, with the hand (palm, back of hand, side of hand), arm, thigh, earlobe, etc. There may be. Hereinafter, blood will be described as a representative body fluid, glucose as a predetermined component, and a fingertip (finger) as a body fluid collection site.

  The collection tool main body 2 has a block-shaped head portion (head) 21 and a cylindrical storage portion 22 that is formed to protrude from the base end portion of the head portion 21.

  On the upper part of the head part 21, a chip installation part 211 in which the chip 4 is installed is provided. In addition, the head portion 21 is provided with a through hole 212 that penetrates the head portion 21. The through hole communicates with the storage portion 22.

  The storage part 22 is a part for storing the puncture needle 3. In addition, the storage portion 22 is preferably formed integrally with the head portion 21.

  The constituent material of the collection tool body 2 is not particularly limited. For example, ABS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, Examples thereof include thermoplastic resins such as fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, and polyethylene terephthalate, and thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester. Moreover, various ceramic materials, various metal materials, etc. can also be used for these constituent materials, for example.

The puncture needle 3 includes a needle body 31 and a hub 32 that supports the needle body 31.
The needle body 31 has a sharp needle tip 311 at the tip thereof. The needle tip 311 can puncture the epidermis (surface of the living body), and thus blood is discharged (outflow) from the epidermis.

  The hub 32 is fixed to the needle body 31. The hub 32 has a cylindrical outer shape. Further, an enlarged diameter portion 321 having an enlarged outer diameter is provided in the middle of the hub 32. When the outer peripheral surface of the enlarged diameter portion 321 is frictionally engaged with the inner peripheral surface of the storage portion 22, the puncture needle 3 is collected in a state where the body fluid sampling device 1 is not attached to the component measuring device 100 (non-attached state). Unintentional detachment from the tool body 2 (housing portion 22) is prevented.

  In the puncture needle 3 having such a configuration, the base end portion of the hub 32 is connected to the puncture means when the body fluid sampling device 1 is attached to the component measuring apparatus 100. By the operation of the puncturing means, the puncture needle 3 can be moved along the longitudinal direction thereof, that is, the needle tip 311 can protrude from the collection tool body 2 to the outside.

  The needle body 31 is preferably composed of a hollow member or a solid member made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy.

  The method for fixing the hub 32 to the needle body 31 is not particularly limited, and examples thereof include a method using fusion, bonding with an adhesive, fitting, caulking, and the like.

  Further, the constituent material of the hub 32 is not particularly limited, but for example, the same constituent material as that of the sampling tool body 2 can be used.

Next, the chip 4 will be described.
The chip 4 shown in FIGS. 1 to 5 includes a chip main body (first member) 5 formed of a plate-like body, a test paper 6 installed on the upper side of the chip main body 5, the chip main body 5 and the test paper 6 And a sheet-like unfolding auxiliary member 7 interposed therebetween, and a lid (second member) 8 formed of a plate-like body. Hereinafter, the configuration of each unit will be described.

  The chip body 5 defines (forms) a blood flow path (body fluid flow path) 50 through which blood passes. As shown in FIG. 2, the chip body 5 includes a flat base portion 51 that is substantially rectangular in a plan view, a tip protrusion portion 52 that protrudes from the distal end portion in the longitudinal direction of the base portion 51, and a lower portion of the base portion 51. And a pair of claw portions 53 that are formed so as to protrude.

  On the upper surface 512 of the base portion 51, a lid installation portion 511 configured with a concave portion that is substantially square in a plan view is formed. The lid body 8 is mounted (installed) on the lid body installation portion 511 from above (see, for example, FIGS. 2 and 3). Further, the lid body setting portion 511 is such that side portions 511a positioned at the top and bottom in FIG. 3 are opened on the side surface 513 of the base portion 51. A part (each ear portion 81) of the lid 8 is fitted to each side portion 511a. Thereby, the lid body 8 is firmly installed on the base 51, and thus, the unintentional detachment of the lid body 8 from the base 51 is prevented. The lid body 8 and the lid body setting portion 511 may be connected by, for example, fusion (thermal fusion, high frequency fusion, ultrasonic fusion, etc.).

  A tip projecting portion 52 is provided at the center of the base 51 in the width direction. The tip protrusion 52 has a shape in which the width gradually decreases in the tip direction. In addition, the blood flow path 50 is open at the distal end surface 521 of the distal protrusion 52. The opening of the blood channel 50 functions as a blood inlet (body fluid inlet) 541 for introducing blood.

  Thus, when the front-end | projection protrusion part 52 is formed, ie, the blood introduction port 541 protrudes toward the front-end | tip direction, when making the blood introduction port 541 contact the puncture site | part of an epidermis, You can do this while checking the position. Thereby, blood introduction port 541 can be reliably spotted (contacted) with blood that has bleed from the puncture site.

  Further, a groove 522 that communicates with the blood flow path 50 is formed in the distal end surface 521 of the distal protrusion 52. In the illustrated example, the groove 522 is a single-letter groove extending in the vertical direction of the tip protrusion 52. Both ends of the groove 522 are open to the outer peripheral surfaces (upper surface and lower surface) of the tip protrusion 52, respectively. By providing the groove 522, the blood flow path 50 is not blocked and the blood inflow path is secured when the front end surface 521 of the front end protrusion 52 is brought into contact with the epidermis when blood is collected. The test paper 6 can be supplied smoothly and reliably.

  A pair of claw portions 53 projecting downward is provided on the distal end side of the lower portion of the base portion 51. Each nail | claw part 53 makes an L-shape when it is seen from the front end side, respectively. In addition, these claw portions 53 are arranged to face each side surface 513 side of the base portion 51. When the chip 4 is installed in the chip installation unit 211 of the head unit 21, the two claw units 53 sandwich (engage) the head unit 21 (chip installation unit 211), and thus the chip 4 is installed in the chip. The unit 211 is firmly connected.

  In addition, protrusions 514 are formed on both side surfaces 513 of the base 51 on the base end side. Each protrusion 514 engages with a recess (not shown) provided in the chip installation part 211 when the chip 4 is installed in the chip installation part 211. Thereby, the chip 4 is firmly connected by the chip installation portion 211.

  Although it does not specifically limit as a constituent material of the chip | tip body 5 of such a structure, For example, the thing similar to the constituent material of the collection tool main body 2 can be used.

  Now, as described above, the blood flow channel 50 through which blood passes is defined in the chip body 5. As shown in FIGS. 3 to 5, the blood flow path 50 is formed on a pipe line (blood introduction path) 54 formed inside the chip body 5 and a bottom part (test paper 6 side) of the lid installation part 511. It is formed by a recessed portion (widened flow path) 55 that is opened (formed) and a groove portion (communication path) 56 that communicates the conduit 54 and the recessed portion 55.

The duct 54 is formed along the longitudinal direction of the chip body 5 (base 51). In addition, the distal end side (the distal end portion (one end portion) 543) of the duct 54 communicates with the blood introduction port 541, and the proximal end portion (the other end portion) 542 communicates with the groove portion 56.
The pipe 54 has a circular cross-sectional shape.

  Further, the distal end 543 (near the blood introduction port 541) of the conduit 54 has a tapered shape in which the inner diameter gradually increases in the distal direction. When blood is collected, the flow rate of blood introduced from the blood inlet 541 is accelerated as it passes through the tip 543. As a result, the blood that has flowed out of the puncture site can be quickly and reliably guided (supplied) to the test paper 6.

  A concave portion 55 is disposed on the proximal end side of the pipe line 54. As shown in FIGS. 4 and 5, the development assisting member 7 is installed on the bottom 551 of the recess 55, and the test paper 6 is laminated (adjacent) on the deployment assisting member 7. Therefore, it can be said that the recessed part 55 has a function as an installation part which installs the expansion | deployment auxiliary member 7 and the test paper 6. FIG.

  As shown in FIG. 3, the recess 55 has a width w that is larger than the inner diameter φa of the proximal end portion 542 of the conduit 54 and has a substantially rectangular (or square) shape in plan view. Since the concave portion 55 has such a shape, when the blood having passed through the groove portion 56 flows into the concave portion 55, it rapidly spreads (expands) in the concave portion 55. Thereby, the blood can be rapidly and reliably spread on the test paper 6 in the recess 55.

  In the bottom portion 551 of the concave portion 55, a groove portion 56 opened (formed) in the bottom portion 551 is disposed. In addition, as shown in FIG. 3, the groove portion 56 is disposed on an extension line of the pipe line 54.

  In other words, as shown in FIGS. 4 and 5, the duct 54, the groove 56, and the recess 55 are substantially straight along the flow direction of the blood introduced from the blood inlet 541 in this order in a side view. It is arranged on the line.

  With such an arrangement, the blood introduced from the blood introduction port 541 can quickly pass through the blood flow path 50, and thus can surely reach the test paper 6. As a result, the blood discharged from the puncture site can be reliably guided to the test paper 6 and further developed with the test paper 6.

  Even when the blood discharged from the puncture site is introduced to the same extent as the necessary blood volume, and it cannot be said that it is more than a sufficient amount or excessive, the blood is surely spread to the test paper 6 Can do.

  Therefore, unintentional consumption of the chip 4 due to measurement failure such as blood not reaching the test paper 6 can be suppressed.

  As shown in FIGS. 2, 3, and 5, the groove portion 56 opens to the edge portion 552 on the distal end side of the bottom portion 551 of the concave portion 55, that is, the base end portion 561 of the groove portion 56 is the bottom portion 551 of the concave portion 55. It is located on the tip side of the central portion 554 of the. Thereby, the groove part 56 is installed in the form which extends a part of flow path in the part ahead of the exit (base end side opening) of the pipe line 54. FIG. Thereby, the stagnation of the inflowing blood at the outlet of the pipeline 54 can be prevented. Further, since the base end portion 561 of the groove portion 56 is located on the front end side with respect to the center portion 554 of the bottom portion 551 of the concave portion 55, the advantage that blood accumulated in the groove portion 56 becomes a base point for flowing into the concave portion 55. There is also.

  As shown in FIG. 3, the groove portion 56 has a width u set to be equal to the inner diameter φa of the pipe 54. Thereby, formation (molding) of the blood channel 50 is facilitated.

  Moreover, the cross-sectional shape of the groove part 56 is not specifically limited, For example, U shape, V shape, square shape etc. are mentioned, U shape is especially preferable among these, and a semicircle is more preferable.

  When the cross-sectional shape of the groove portion 56 is semicircular, blood that has passed through the duct 54 having a circular cross-sectional shape can smoothly flow into the groove portion 56.

  As shown in FIG. 4, the magnitude relationship among the inner diameter φa of the conduit 54, the depth b of the recess 55, and the depth c of the groove 56 satisfies φa> b and φa> c. As a result, the blood that has flowed out from the puncture site of the epidermis can pass through the blood channel 50 quickly (smoothly), and is thus reliably guided to the test paper 6.

  In the illustrated configuration, the depth b is constant along the direction of blood flow (longitudinal direction of the chip body 5), but is not limited to this. For example, the depth b gradually increases in the proximal direction. It may be decreased.

  When the depth b gradually decreases toward the proximal direction, the flow velocity of the blood in the concave portion 55 is promoted more than in the case where the depth b is constant. Can do.

  Moreover, it is preferable that the whole or a part of the blood channel 50 (for example, the concave portion 55 and the groove portion 56) is subjected to a hydrophilic treatment. As a result, blood is rapidly (reliably) introduced into the blood flow path 50, and thus can be reliably reached by the test paper 6. As the hydrophilization treatment, for example, physical activation treatment such as plasma treatment, glow discharge, corona discharge, ultraviolet irradiation, etc., addition of surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol and the like ( Etc.).

  As shown in FIGS. 2, 3, and 5, the chip body 5 has an exhaust passage 57 communicating with the recess 55. The exhaust path 57 discharges air in the blood flow path 50 when blood is introduced into the blood flow path 50. The exhaust passage 57 is disposed (positioned) on the side opposite to the groove portion 56 via the recess 55.

  By forming such an exhaust path 57, when passing through the blood flow path 50, the blood flows down while pushing the air in the blood flow path 50 toward the exhaust path 57 (downstream side). Thereby, the blood can smoothly pass through the blood flow path 50, and thus the blood reliably reaches the test paper 6.

  As described above, the lid body 8 is installed in the lid body installation portion 511 of the chip body 5 (base 51). As shown in FIGS. 4 and 5, the lid 8 has a function of supporting and fixing the test paper 6 and the development auxiliary member 7 to the chip body 5 in a lump.

  The lid body 8 is a flat shape having a substantially square shape in plan view. The lid body 8 is formed with protruding ears 81 on two opposing sides. Each ear 81 has a long shape along the longitudinal direction of the side. Each of the ears 81 is fitted into the side part 511a of the lid installation part 511 (see FIGS. 1 and 3).

  In addition, the lid 8 has a window portion 82 formed of an opening through which the test paper 6 is exposed at the center thereof. The window 82 is for measuring the color of the colored test paper 6 by the component measuring apparatus 100. In other words, as shown in FIG. 5, the light emitted (emitted) from the light emitting element (light emitting diode) 101 of the component measuring apparatus 100 is incident on the test paper 6 through the window 82, and is incident on the test paper 6. The light is reflected by the test paper 6 and enters the light receiving element (photodiode) 102 through the window 82, that is, is received by the light receiving element 102.

  As shown in FIG. 3, in the chip 4, the width w of the recess 55 is preferably equal to or greater than the diameter φd of the window portion 82, and more preferably substantially equal. Thereby, there is an advantage that the necessary sample amount can be minimized, and the blood filling the concave portion 55 immediately comes into contact with the test paper 6 and can infiltrate the necessary measurement region.

  As shown in FIG. 6, a plurality of protrusions 83 are provided on the lower surface of the lid 8 on the outer peripheral side of the window 82 along the circumferential direction. Of these protrusions 83, the remaining protrusions 83 excluding the protrusions 83 a located on the most distal side, that is, in the vicinity of the groove 56 of the recess 55, are bonded to the test paper 6 by, for example, fusion (thermal fusion). Bonding, high frequency fusion, ultrasonic fusion, etc.). As a result, the test paper 6 is intermittently supported and fixed along the circumferential direction thereof, so that the test paper 6 is positioned with respect to the window portion 82, that is, an unintentional position of the test paper 6 with respect to the window portion 82. Misalignment is prevented. The remaining protrusions 83 each have a hemispherical shape (dome shape).

  Further, the protrusion 83 a has a portion 831 whose height is set higher than that of the remaining protrusion 83. The portion 831 faces the groove portion 56 and protrudes toward the groove portion 56. By this portion 831, the front end portion of the test paper 6 and the front end portion of the development assisting member 7 are surely held together toward the groove portion 56. Thereby, the front-end | tip part of the test paper 6 and the front-end | tip part of the expansion | deployment auxiliary member 7 will be in the state which adjoined to the groove part 56, respectively, Therefore, the flow of the blood from the groove part 56 to the recessed part 55 is accelerated | stimulated. As a result, the blood surely flows into the recess 55, so that the supply (development) of blood to the test paper 6 is performed more quickly and more reliably.

  Thus, the protrusion 83a functions as a flow promoting means for promoting the blood flow from the groove 56 to the recess 55.

  In addition, although it does not specifically limit as a constituent material of the cover body 8, For example, the thing similar to the constituent material of the collection tool main body 2 can be used.

The test paper 6 detects glucose in the blood that has passed through the blood channel 50.
The overall shape of the test paper 6 is preferably a circle, but is not limited to this, and for example, an oval, a square, a rectangle, a rectangle such as a rhombus, a triangle, a hexagon, an octagon, etc. are selected and used as necessary. be able to. Further, the size of the test paper 6 is set larger than that of the concave portion 55 in plan view, and covers the entire concave portion 55 from above (see FIG. 3).

  Such a test paper 6 is obtained by carrying (impregnating) a reagent (coloring reagent) on a carrier capable of absorbing blood. This carrier is preferably composed of a porous sheet.

  Sufficient supply of oxygen in the atmosphere after blood is spread on the test paper 6 when the reagent to be impregnated is a reagent system including a process using oxygen such as an oxidase reaction, by using a carrier made of a porous sheet. As a result, the reaction can proceed rapidly, and the color development state can be detected without removing blood or its filtered components (such as red blood cells).

  Examples of the carrier using the porous sheet include a nonwoven fabric, a woven fabric, a stretched sheet, a membrane filter, and filter paper. Examples of the constituent material include polyesters, polyamides, polyolefins, polysulfones, celluloses, silicates, and fluorine resins. More specifically, for example, polyethylene terephthalate, polybutylene terephthalate, polyethersulfone, nitrocellulose, cellulose, glass, polytetrafluoroethylene (Teflon: “Teflon” is a registered trademark) and the like can be mentioned.

  A material constituting such a carrier is preferably a material manufactured by impregnating an aqueous solution in which a reagent is dissolved, or a hydrophilic material or a material that has been hydrophilized in order to rapidly absorb and develop blood. .

  Examples of the reagent carried on the test paper 6 include glucose oxidase (GOD), peroxidase (POD), 4-aminoantipyrine, N-ethyl-N- (2-hydroxy-3-, for blood glucose measurement. Examples include color formers (color development reagents) such as sulfopropyl) -m-toluidine, and others that react with blood components such as ascorbate oxidase, alcohol oxidase, cholesterol oxidase, etc., depending on the measurement components, And the same color former (coloring reagent). Further, a buffering agent such as a phosphate buffer may be included. Needless to say, the types and components of the reagents are not limited to these.

On the lower surface of the test paper 6, a development auxiliary member 7 is installed adjacent to the test paper 6. The development assisting member 7 assists in developing the blood that has passed through the blood flow path 50 onto the test paper 6.
The deployment assisting member 7 is a sheet-like mesh member.

  The numerical aperture per inch of the development assisting member 7 is not particularly limited, but is preferably 30 to 300, for example, and preferably 100 to 150.

  Moreover, the expansion | deployment auxiliary | assistant member 7 is comprised by making a several wire cross | intersect mutually (orthogonally). When manufacturing this expansion | deployment auxiliary | assistant member 7, it is preferable to process wires by heat press, for example. As a result, the wire rods can be engaged with each other at the crossing portion, and thus fraying of the wire rods can be prevented. Moreover, although the wire diameter of each wire is not particularly limited, for example, it is preferably about 10 to 200 μm, and more preferably 30 to 100 μm. Examples of the constituent material of each wire include polyolefin such as polyamide, polyethylene, and polypropylene, polyester such as polyethylene terephthalate and polybutylene terephthalate, nylon, cellulose, polyurethane, and aramid fiber.

  Moreover, the thickness in the natural state of the expansion | deployment auxiliary member 7 is although it does not specifically limit, For example, it is preferable that it is about 20-400 micrometers, and it is more preferable that it is 50-150 micrometers.

  Moreover, it is preferable that the expansion | deployment auxiliary member 7 has hydrophilicity. That is, it is preferable that the expansion | deployment auxiliary | assistant member 7 is comprised with the material which has hydrophilicity itself, or the hydrophilic treatment (for example, plasma treatment, a hydrophilic coat etc.) is performed. Thereby, the blood which passed through the groove part 56 can be more reliably expanded toward the test paper 6 via the expansion | deployment auxiliary member 7. FIG.

  As shown in FIG. 3 (the same applies to FIG. 2), the maximum width v of the deployment assisting member 7 is substantially equal to the width w of the recess 55, and the length k is set to be approximately equal to the length L of the recess 55. ing. As a result, the deployment assisting member 7 is positioned with respect to the recess 55, and thus it is possible to reliably prevent the deployment assisting member 7 from moving unintentionally within the recess 55. Further, blood filling into the concave portion 55 is quickly performed by a capillary suction force in the gap between the development auxiliary member 7 and the bottom portion 551 of the concave portion 55 or the gap between the development auxiliary member 7 and the test paper 6. Thereby, there exists an advantage that the infiltration of the required measurement area | region of the test paper 6 can be performed reliably.

  Further, the area of the development assisting member 7 in plan view is smaller than that of the test paper 6. Such a deployment assisting member 7 is located substantially at the center of the test paper 6 in plan view.

  Thereby, the blood can be reliably supplied toward the portion (in the present embodiment, the center portion of the test paper 6) where the blood is to be developed on the test paper 6, that is, the blood can be developed.

  The deployment assisting member 7 has a distal end portion (part) 71 whose width gradually decreases in the distal end direction. The tip 71 faces the groove 56.

  Thereby, the blood passing through the groove 56 is promoted particularly at the tip 71. Thereby, blood can be developed on the test paper 6 more quickly. In addition, the blood that has passed through the groove 56 is prevented or suppressed from flowing near the corner portion 553 that is located on the distal end side of the concave portion 55, so that the amount of blood necessary for measurement is insufficient, that is, blood loss (loss). ) Can be prevented.

Next, an example of a usage pattern (usage state) of the body fluid sampling tool 1 (chip 4) will be described.
First, the component measuring apparatus 100 to which the body fluid collecting tool 1 is attached will be described.

  As shown in FIG. 5, the component measuring apparatus 100 has a chip mounting portion 103 to which the body fluid collecting tool 1 is detachably mounted. A light emitting element 101 and a light receiving element 102 are provided near the inside of the chip mounting portion 103. The light emitting element 101 emits pulsed light at a predetermined time interval, for example.

  Moreover, the component measuring apparatus 100 has a control means (not shown) comprised with a microcomputer. This control means includes a calculation unit that calculates glucose based on a signal from the light receiving element 102.

  The body fluid collecting tool 1 is mounted on the chip mounting unit 103, and the sample is supplied to and spread on the test paper 6 of the chip 4 as described later, and then measurement is performed. When the light emitting element 101 is turned on, the light emitted from the light emitting element 101 is applied to the test paper 6 of the chip 4 to obtain the reflected light. The intensity of the reflected light corresponds to the color intensity of the test paper 6, that is, the amount (concentration) of glucose in the blood. This reflected light is received by the light receiving element 102 and photoelectrically converted. From the light receiving element 102, an analog signal corresponding to the amount of received light is output, and the signal is converted into a digital signal and then input to the control means, where desired calculation processing, correction processing, etc. are performed, and glucose in the blood is The amount is quantified (blood glucose level is determined).

  Next, a usage pattern (usage method) of the body fluid sampling device 1 (chip 4) mounted on the component measuring apparatus 100 will be described.

  First, the puncture mechanism of the component measuring apparatus 100 is operated. As a result, the fingertip is punctured with the puncture needle 3, and a very small amount (for example, 1 μL or less) of blood flows out (discharges) from the puncture portion onto the skin.

  The blood at the fingertip reaches the blood inlet 541. Thereafter, the blood sequentially passes through the conduit 54, the groove 56, and the recess 55 as described above by capillary action. The blood that has flowed into the recess 55 is supplied to the test paper 6 via the development assisting member 7 (developed on the test paper 6).

  As blood is supplied onto the test paper 6, glucose in the blood reacts with the reagent carried on the test paper 6, and the test paper 6 is colored according to the amount of glucose.

  By measuring the color intensity of the test paper 6 optically with the component measuring apparatus 100 as described above, the amount of glucose (blood glucose level) in the blood can be obtained.

  After completion of the measurement, the body fluid collecting tool 1 is removed from the chip mounting portion 103. The removed used bodily fluid collecting tool 1 is removed for disposal.

<Second Embodiment>
FIG. 7 is a plan view showing a second embodiment of the component measuring chip of the present invention.

  Hereinafter, the second embodiment of the component measuring chip of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the size (width) of the groove is different.

  In the chip 4 </ b> A shown in FIG. 7, the width u of the groove 56 </ b> A is set larger than the width u of the groove 56 of the first embodiment, that is, the inner diameter φa of the conduit 54. At this time, the stagnation of blood can be prevented by making the depth c of the groove portion 56A shallower than the groove portion 56 of the first embodiment and applying a slope so as to eliminate the step at the outlet of the conduit 54. it can.

<Third Embodiment>
FIG. 8 is a longitudinal sectional view showing a third embodiment of the component measuring chip of the present invention.

  Hereinafter, the third embodiment of the component measuring chip of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the shape of the groove is different.
In the chip 4 </ b> B shown in FIG. 8, the groove portion 56 </ b> B has a depth gradually decreasing portion 562. The depth gradually decreasing portion 562 is a portion where the depth c of the base end portion 561 is continuously shallowed (gradually decreased) in the base end direction.

  By forming this gradually decreasing portion 562, the blood passing through the groove 56B is prevented or suppressed from staying in the groove 56B. Thereby, the blood that has passed through the groove 56B is promoted to flow, and thus flows quickly (smoothly) toward the recess 55.

  Further, the depth gradually decreasing portion 562 can be said to be a flow promoting means for promoting the blood flow from the groove portion 56B to the concave portion 55.

  Further, the inner diameter φa of the base end portion 542 of the pipe line 54 is gradually reduced toward the base end direction. As a result, the blood that has flowed into the conduit 54 is promoted by the proximal end portion 542, and thus quickly flows into the groove portion 56B.

<Fourth embodiment>
9 is a plan view showing a fourth embodiment of the component measuring chip of the present invention, FIG. 10 is a cross-sectional view taken along the line BB in FIG. 9, and FIG. 11 is a cross-sectional view taken along the line CC in FIG. 12 is a cross-sectional view taken along a line DD in FIG. 9, and FIG. 13 is a cross-sectional view taken along a line EE in FIG.

  Hereinafter, the fourth embodiment of the component measuring chip of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the shape of the groove is different.
In the chip 4 </ b> C shown in FIG. 9, the width u of the groove 56 </ b> C gradually increases toward the base end direction. Further, the depth c of the groove 56C gradually decreases from the distal end to the proximal end in the proximal direction (see FIG. 10).

  In the groove portion 56 </ b> C having such a shape, the radius of curvature R of the inner peripheral surface (bottom surface) 563 continuously increases in the proximal direction (see FIGS. 11 to 13).

  By providing the groove portion 56 </ b> C having the above configuration, blood can smoothly flow from the groove portion 56 </ b> C to the recessed portion 55. Thereby, blood is more reliably guided to the test paper 6.

  As shown in FIG. 10, in this embodiment, the pipe 54 may have an inner diameter φa of the base end portion 542 gradually decreasing in the base end direction, as in the second embodiment.

  As described above, the component measuring chip of the present invention has been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each component constituting the component measuring chip is an arbitrary element that can exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added.

  Moreover, the component measuring chip of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  For example, the groove part of the second embodiment may have a depth gradually decreasing part like the groove part of the third embodiment.

  In addition, the inner diameter of the proximal end portion of the pipe line of the second embodiment may be gradually reduced in the proximal direction like the inner diameter of the proximal end part of the pipe line of the third embodiment.

It is a perspective view which shows 1st Embodiment at the time of applying the chip | tip for a component measurement of this invention to the bodily fluid collection tool in which the puncture needle was accommodated. FIG. 2 is an exploded perspective view of the component measurement chip shown in FIG. 1. It is a top view of the chip | tip for a component measurement shown in FIG. It is the sectional view on the AA line in FIG. It is the schematic (partial longitudinal cross-sectional view) which shows the state which loaded the body fluid collection tool (chip for a component measurement) shown in FIG. 1 in the component measuring device. It is a perspective view of the cover body of the component measuring chip shown in FIG. It is a top view which shows 2nd Embodiment of the chip | tip for a component measurement of this invention. It is a longitudinal cross-sectional view which shows 3rd Embodiment of the chip | tip for a component measurement of this invention. It is a top view which shows 4th Embodiment of the chip | tip for a component measurement of this invention. It is the BB sectional view taken on the line in FIG. It is CC sectional view taken on the line in FIG. It is the DD sectional view taken on the line in FIG. It is the EE sectional view taken on the line in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Body fluid collection tool 2 Collection tool main body 21 Head part (head)
211 Tip installation portion 212 Through hole 22 Storage portion 3 Puncture needle 31 Needle body 311 Needle tip 32 Hub 321 Expanded portion 4, 4A, 4B, 4C Tip (component measurement tip)
5 Chip body (first member)
50 Blood channel (body fluid channel)
51 Base 511 Lid Installation Portion 511a Side 512 Upper Surface 513 Side 514 Projection 52 Tip Projection 521 Tip Surface 522 Groove 53 Claw 54 Pipe (Blood Introduction Channel)
541 Blood inlet (body fluid inlet)
542 Base end (other end)
543 Tip (one end)
55 Concave part (widened flow path)
551 Bottom portion 552 Edge portion 553 Corner portion 554 Center portion 56, 56A, 56B, 56C Groove (communication path)
561 Base end portion 562 Depth decreasing portion 563 Inner peripheral surface (bottom surface)
57 Exhaust path 6 Test paper 7 Deployment assisting member 71 Tip (part)
8 Lid (second member)
81 Ear part 82 Window part 83, 83a Projection part 831 Part 100 Component measuring device 101 Light emitting element (light emitting diode)
102 Light receiving element (photodiode)
103 Chip mounting part

Claims (17)

A first member configured with a plate-like body and defining a body fluid flow path through which the body fluid passes;
A test paper installed on the first member for detecting a predetermined component in the body fluid that has passed through the body fluid flow path;
A deployment auxiliary member that is installed adjacent to the test paper and assists in spreading the body fluid that has passed through the body fluid flow path on the test paper;
A second member having a function of fixing the test paper and the development auxiliary member to the first member;
The bodily fluid channel is formed inside the first member, one end of which opens as a bodily fluid inlet for introducing bodily fluid, and the inner diameter of the other end of the tube that opens on the test paper side. A component measuring chip comprising: a recess having a wider width; and a groove opening at the bottom of the recess and communicating the other end of the conduit with the recess.   The component measuring chip according to claim 1, wherein a> b is satisfied, where a is an inner diameter of the pipe and b is a depth of the recess.   The said pipe line, the said groove part, and the said recessed part are arrange | positioned substantially linearly along the flow direction of the bodily fluid introduce | transduced from the said bodily fluid inlet in this order in side view. Component measurement chip.   The component measuring chip according to any one of claims 1 to 3, wherein an inner diameter of the one end portion of the conduit is gradually increased in a distal direction.   The component measuring chip according to any one of claims 1 to 4, wherein one end portion of the pipe line protrudes in a distal direction.   The component measuring chip according to claim 1, wherein the groove is open at an edge of the bottom of the recess.   The component measuring chip according to claim 1, wherein a width of the groove is equal to an inner diameter of the other end of the pipe.   The component measuring chip according to any one of claims 1 to 7, wherein the groove portion has a portion whose depth is continuously shallow at a base end portion thereof.   9. The component measuring chip according to claim 1, wherein the concave portion has a substantially rectangular or square shape in plan view. The deployment assisting member is installed in the recess,
The component measuring chip according to claim 1, wherein the test paper is laminated on the development assisting member.   The component measuring chip according to claim 1, wherein the development assisting member is configured by a mesh-like member having a sheet shape.   The component measuring chip according to any one of claims 1 to 11, wherein the development assisting member has an area smaller than that of the test paper in a plan view and is positioned substantially at the center of the test paper in a plan view.   The component measuring chip according to any one of claims 1 to 12, wherein the development assisting member has a portion whose width gradually decreases in the distal direction.   14. The first member according to claim 1, wherein the first member communicates with the recess and defines an exhaust path for discharging air in the bodily fluid channel when the bodily fluid is introduced into the bodily fluid channel. The chip | tip for a component measurement of description.   The component measuring chip according to claim 1, wherein the second member has a window portion for measuring the color of the colored test paper.   The component measuring chip according to claim 1, further comprising a flow promoting unit that promotes a flow of body fluid from the groove to the recess.   17. The component measurement device according to claim 16, wherein the flow promoting means is configured by a protrusion provided on the second member and protruding toward the groove portion in the vicinity of the groove portion of the concave portion to suppress the test paper. Chip.

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