JP4050773B2 - Component measurement chip - Google Patents

Description

  The present invention relates to a component measuring chip for measuring the amount of a target component in a specimen, such as blood glucose level measurement.

  A blood glucose measurement device (blood component measurement device) that measures blood glucose levels is known. This blood glucose measuring device supplies and develops blood 200 (specimen) on a test paper colored according to the amount of glucose in the blood, and optically measures (colorimetry) the degree of coloration of the test paper. The value is quantified.

  In such a conventional blood glucose measurement device, a component measurement chip is attached, and blood 200 is collected from the component measurement chip. The collected blood 200 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 (blood test tool), a bottomed cylindrical (cup-shaped) chip body (holder), a test paper (blood-absorbing member) installed inside the bottom of the chip body, and a chip body (See, for example, JP-A-10-1988). When blood 200 (specimen) is brought into contact with the tip of a capillary tube with such a component measurement chip mounted on a blood glucose measurement device, blood 200 is sucked into the capillary tube by capillary action and reaches the test paper.

  By the way, in recent years, for example, when blood 200 is discharged from a patient, pain at the time of puncture to the patient (puncture pain) is reduced, and a component measurement chip (capillary tube) is attached (dropped) to blood 200. In order to prevent operation failure, the amount of blood 200 collected (attached) tends to be very small (for example, 1 μL or less).

  However, in the component measuring chip, since the outer diameter of the thin tube is thin (small), that is, the area where blood 200 can adhere (contact) in the thin tube is small, when the attachment position with respect to blood 200 is shifted, blood 200 There is a problem in that it may be difficult to reliably collect the sample.

  In addition, the code | symbol here is a thing as described in the said gazette.

  An object of the present invention is to provide a component measuring chip capable of reliably collecting even a very small amount of sample.

In order to achieve the above object, the component measuring chip of the present invention comprises:
A housing having a tip for contacting the skin, and a through-hole opening in the tip;
A test paper that can absorb the specimen on one side, a nesting body that comes into contact with the test paper, and a nesting that is formed on the nesting body and has a protrusion that is inserted into the through hole. A component measuring chip,
In order to guide the specimen to the test paper, a gap formed between the outer periphery of the protrusion and the inner periphery of the through hole in a state in which the protrusion of the insert is inserted into the through hole of the housing. It is a chip | tip for a component measurement characterized by using as a flow path.

  Thereby, even if it is a trace amount sample, the sample can be collected reliably.

  In the component measuring chip of the present invention, it is preferable that the tip portion has a center pole portion projecting and formed in a mountain shape, and the through hole is opened around or around the center pole portion. .

  Thereby, even a very small amount of sample can be collected more reliably.

In the component measurement chip of the present invention, the housing has a plurality of the through holes arranged radially from the center of the housing,
It is preferable that a plurality of the protrusions are arranged radially from the center of the insert.

  Thereby, in the state which inserted the protrusion part of the nest into the through hole of the housing, a gap can be surely formed between the outer peripheral part of the protrusion part and the inner peripheral part of the through hole.

  In the component measurement chip of the present invention, it is preferable that the center of each projection is eccentric with respect to the center of each through hole in a state where the housing and the insert are combined.

  Thereby, even a very small amount of sample can be collected more reliably.

  In addition, the component measuring chip of the present invention preferably includes means for collecting the specimen that has passed through the flow path at the center of the test paper.

  As a result, in a state where the protrusion of the insert is inserted into the through-hole of the housing, a gap can be formed between the insert-side taper portion and the housing-side taper portion. The phenomenon is surely collected in the center of the test paper through the gap.

In the component measurement chip of the present invention, a housing-side taper portion whose outer diameter gradually decreases in a direction opposite to the protruding direction of the tip portion is provided on the back surface of the housing.
The surface of the nesting body is provided with a nesting side taper portion whose inner diameter gradually increases toward the protruding direction of the protruding portion,
In a state where the housing and the insert are combined, it is preferable that the housing side taper portion and the insert side taper portion face each other.

  As a result, in a state where the protrusion of the insert is inserted into the through-hole of the housing, a gap can be formed between the insert-side taper portion and the housing-side taper portion. The phenomenon is surely collected in the center of the test paper through the gap.

The component measuring chip of the present invention is
A chip body;
A center pole formed to project in a mountain shape at the tip of the chip body;
A channel formed around or on the slope of the center pole portion, through which the specimen can pass,
A component measuring chip comprising a test paper capable of absorbing the specimen and installed on the back side of the chip body.

  Thereby, even if it is a trace amount sample, the sample can be collected reliably.

  In the component measurement chip of the present invention, it is preferable that the flow path is constituted by a gap formed by combining two different members.

  Thereby, even a very small amount of sample can be collected more reliably.

  In the component measuring chip of the present invention, it is preferable that the tip of the protruding portion protrudes from the through hole of the housing in a state where the housing and the insert are combined.

  This prevents the inlet (opening) of the flow path from being blocked when the tip of the component measurement chip is brought into contact with (abuts) the skin when collecting the specimen. Can be smoothly and reliably supplied.

  In the component measuring chip of the present invention, it is preferable that the tip of the protruding protrusion is located at a position lower than the tip of the tip.

  As a result, the entire shape of the tip of the component measurement tip can be a mountain with a gentle slope, so that the outer diameter (average) of the tip of the component measurement tip is larger than the outer diameter of the base end. It becomes smaller (thinner). With such a shape, when the component measurement chip is attached (contacted) to the specimen, the attachment position is easily visually recognized (confirmed), and thus the component measurement chip can be accurately attached.

  In the component measuring chip of the present invention, it is preferable that each protrusion of the insert is formed corresponding to each of the plurality of through holes of the housing.

  Thereby, in the state which inserted the protrusion part of the nest into the through hole of the housing, a gap can be surely formed between the outer peripheral part of the protrusion part and the inner peripheral part of the through hole.

  In the component measuring chip of the present invention, it is preferable that the center of each of the protrusions is eccentric to the central axis side of the tip.

  Thereby, the flow path is set such that the width on the central axis side of the component measuring chip is smaller than the width on the outer peripheral side of the component measuring chip. By such a flow path, the capillary phenomenon preferentially appears on the central axis side of the component measurement chip in the flow path compared to the outer peripheral side of the component measurement chip. It can be reliably collected by the center of the.

  In addition, the component measuring chip of the present invention preferably includes positioning means for positioning so that the center of the housing and the insert is aligned in a state where the housing and the insert are combined.

  Thereby, a housing and a nest | insert are correctly positioned.

  In the component measuring chip of the present invention, the positioning means includes a guide pin provided at the center of the back surface of the housing and a guide hole provided at the center of the nesting body and into which the guide pin is inserted. Preferably, it is configured.

  Thereby, a housing and a nest | insert are correctly positioned.

  In the component measuring chip of the present invention, it is preferable that a lip portion provided concentrically with the tip portion and projecting in a ring shape is formed on the outer peripheral side of the through hole.

  Thus, when the skin contacts the housing, the specimen can be easily and surely introduced into the through-hole without missing the specimen.

  In the component measuring chip of the present invention, it is preferable that the through hole is provided substantially parallel to the protruding direction of the tip.

  Thereby, even a very small amount of sample can be collected more reliably.

  In the component measuring chip of the present invention, it is preferable that a taper angle of the nesting side taper portion is smaller than a taper angle of the housing side taper portion.

  As a result, the gap formed between the nesting side taper portion and the housing side taper portion in a state where the nesting protrusion is inserted into the through hole of the housing gradually decreases in width toward the central axis of the component measuring chip. That is, the gap forms a convergent shape. Therefore, a capillary phenomenon appears remarkably near the center of the gap. Therefore, the specimen that has passed through the flow path can be reliably collected at the center of the test paper.

  In the component measuring chip of the present invention, it is preferable that the housing-side tapered portion and / or the nesting-side tapered portion is provided with a plurality of concave portions or convex portions.

  As a result, the gap between the housing-side taper portion and the nesting-side taper portion becomes small (narrow) in a state where the nesting protrusion is inserted into the through hole of the housing. Therefore, the specimen flowing down the flow path enters the gap between the housing-side taper portion and the nesting-side taper portion, and can easily reach the center portion of the test paper through the gap by capillary action.

  In the component measuring chip of the present invention, it is preferable that a part of the test paper is supported on the one surface of the nesting body.

  This ensures that the specimen that has passed through the flow path reaches the test paper.

  In the component measuring chip of the present invention, it is preferable that the housing and the insert are fixed to each other by bonding or fusion in a state where the housing and the insert are combined.

  This prevents the nest from unintentionally leaving the housing.

  In the component measurement chip of the present invention, it is preferable that the outer peripheral portion of the protrusion and / or the inner peripheral portion of the through hole is subjected to a hydrophilic treatment.

  As a result, the sample is quickly (reliably) introduced into the flow path, and can thus be reliably reached by the test paper.

  In the component measuring chip of the present invention, it is preferable that the housing and the nesting are made of the same or different materials.

  Thereby, when the same constituent material is used, the kind of constituent material to be used decreases, and it can suppress manufacturing cost. When different constituent materials are used, for example, materials suitable for molding of the housing and the insert can be used.

FIG. 1 is a perspective view of a component measuring chip of the present invention. FIG. 2 is a front view of the component measuring chip shown in FIG. FIG. 3 is a front view of a housing provided in the component measuring chip shown in FIG. FIG. 4 is a side view of the housing shown in FIG. FIG. 5 is a rear view of the housing shown in FIG. FIG. 6 is a cross-sectional view taken along line AA in FIG. FIG. 7 is a front view of a nest provided in the component measuring chip shown in FIG. FIG. 8 is a side view of the nest shown in FIG. FIG. 9 is a rear view of the nest shown in FIG. FIG. 10 is a sectional view taken along line BB in FIG. FIG. 11 is a longitudinal sectional view showing a state where the component measuring chip shown in FIG. 1 is attached to the component measuring apparatus and blood (body fluid) is collected. FIG. 12 is an enlarged detailed view of a region [C] surrounded by a two-dot chain line in FIG.

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

  1 is a perspective view of a component measuring chip according to the present invention, FIG. 2 is a front view of the component measuring chip shown in FIG. 1, and FIG. 3 is provided in the component measuring chip shown in FIG. FIG. 4 is a side view of the housing shown in FIG. 3, FIG. 5 is a rear view of the housing shown in FIG. 3, and FIG. 6 is a cross-sectional view taken along line AA in FIG. 7 is a front view of the nest included in the component measuring chip shown in FIG. 1. FIG. 8 is a side view of the nest shown in FIG. 7. FIG. 9 is a side view of the nest shown in FIG. FIG. 10 is a rear view, FIG. 10 is a cross-sectional view taken along the line BB in FIG. 7, and FIG. 11 is a diagram for collecting blood (body fluid) by mounting the component measuring chip shown in FIG. FIG. 12 is an enlarged detailed view of a region [C] surrounded by a two-dot chain line in FIG. 1, 11, and 12, the left side is the “tip”, the right side is the “base end”, and the right side in FIGS. 4, 6, 8, and 10 is the “tip”. ”And the left side as“ base end ”.

  As shown in FIG. 11, the component measuring chip 1 (hereinafter simply referred to as “chip 1”) is mounted on the chip mounting portion 101 of the component measuring apparatus 100 and used. Hereinafter, a state where the chip 1 is mounted on the chip mounting unit 101 of the component measuring apparatus 100 is referred to as a “chip mounting state”.

  As shown in FIGS. 1 and 11, the chip 1 includes a housing 6, a nest 7, and a test paper 5 that abuts on the base end side of the nest 7. In the chip 1, the chip body 2 is constituted by the housing 6 and the insert 7 excluding the test paper 5.

  As shown in FIGS. 3 to 6, the housing 6 includes a housing main body 61, a center pole portion 3 projecting and formed at the tip of the housing main body 61 (chip body 2), and a center pole portion 3. And a through hole 31 formed in the periphery or on the slope.

  As shown in FIG. 7 to FIG. 10, the insert 7 is formed in the insert body 71 that is in contact with the test paper 5 on the base end side (one side), and is inserted into the through hole 31 of the housing 6. And a protruding portion 4 to be formed.

  When the projection 4 of the insert 7 is inserted into the through hole 31 of the housing 6 from the base end side of the housing 6, the chip 1 is assembled with the insert 6 as shown in FIG. 1 (FIG. 11). (Combined) state (hereinafter referred to as “assembled state”).

  As shown in FIG. 11, the test paper 5 is supported and fixed at a peripheral edge portion thereof to a test paper fixing portion 68 provided on the edge of the back surface of the housing 6. The test paper 5 can be supported and fixed by, for example, fusion using ultrasonic waves or adhesion using an adhesive. Further, the peripheral edge of the test paper 5 may be sandwiched and pressed by another member from the base end side of the housing 6.

  The front end side surface of the test paper 5 is set so as to contact the proximal end side of the nested body 71.

  In the assembled state, an annular narrow gap is formed between the inner peripheral surface of the through hole 31 and the outer peripheral surface of the protrusion 4. Thereby, a narrow gap can be formed in a wide range of the tip portion 12 of the chip 1. Thereby, when the fingertip 400 contacts the distal end portion 12 of the housing 6 (chip 1), the blood 200 can be brought into contact with a narrow gap in a wide range, and the blood 200 can be easily and reliably introduced into the flow path 11. Can do.

  Hereinafter, the configuration of each part in the chip 1 will be described.

  First, the housing 6 will be described.

  As shown in FIG. 6, the housing main body 61 has a bottomed cylindrical shape.

  It is preferable that the outer diameter of the housing main body 61 is substantially equal to or smaller than the outer diameter of the tip mounting portion 101. In the illustrated embodiment, the outer diameter of the housing body 61 is set substantially equal to the outer diameter of the tip of the chip mounting portion 101. Thereby, even when a finger or the like touches the outer edge portion of the housing body 61 (chip 1), the chip 1 is prevented from being unintentionally detached from the chip mounting portion 101.

  A center pole 3 that protrudes toward the distal end is provided at the center on the distal end side of the bottom 63 (front end) of the housing body 61. The center pole portion 3 has a truncated cone shape (mountain shape).

  As shown in FIGS. 3 and 6, at least one through-hole 31 is provided around the center pole portion 3 or on the inclined surface, that is, at a position shifted (eccentric) from the center of the center pole portion 3. Yes. The through hole 31 has a circular cross-sectional shape.

  As shown in the figure, a plurality of (four in this embodiment) through holes 31 are arranged along the periphery of the center pole portion 3, that is, radially from the center of the center pole portion 3 (housing 6). Is preferred. The plurality of through holes 31 are more preferably arranged at equiangular intervals.

  As shown in FIGS. 4 and 6, the housing body 61 (housing 6) is formed with a lip portion (bank) 62 protruding in a ring shape (annular shape). The lip portion 62 is provided concentrically with the center pole portion 3 so as to surround the outer peripheral side of each through hole 31.

  By forming such a lip portion 62, when the fingertip (skin) 400 comes into contact with the housing 6 (chip 1), the blood 200 does not escape, so that the blood 200 can be easily and easily passed through each through-hole 31. It can be reliably introduced (see FIG. 11).

  A housing-side taper portion 64 is provided at the base end side central portion (back surface) of the bottom portion 63 of the housing body 61. The housing-side taper portion 64 has an outer diameter that gradually decreases in the direction opposite to the protruding direction of the center pole portion 3, that is, in the proximal direction.

  In addition, a guide pin (projecting portion) 65 that slightly projects in the proximal direction is provided at the center of the housing-side tapered portion 64. The guide pin 65 is inserted into a guide hole 73 of the insert 7 described later in an assembled state.

  Further, as shown in FIG. 5, the housing side taper portion 64 is provided with four convex portions 66 arranged radially at equal angular intervals. With such a convex portion 66, the gap between the housing-side taper portion 64 and a nesting-side taper portion 72 to be described later becomes small (narrow) in the assembled state. As a result, the blood 200 flowing down the flow path 11 enters the gap between the convex portion 66 and the nesting side taper portion 72, and passes through this gap due to capillary action, and is caused by the central portion of the nesting body 71 (test paper 5). Can be reached easily.

  In addition, although the internal diameter of the through-hole 31 is not specifically limited, For example, it is preferable that it is 0.1-5 mm, and it is more preferable that it is 0.5-2 mm.

  Next, the nesting 7 will be described.

  As shown in FIGS. 7 and 8, the nesting body 71 has a disk shape.

  In the assembled state, the nesting body 71 is installed (stored) in the lumen 67 of the housing body 61 (housing 6) (see FIG. 11).

  A plurality of (four in this embodiment) projections 4 projecting in the distal direction are provided at the distal end of the nested body 71. Further, each protrusion 4 has a cylindrical shape, that is, its cross-sectional shape has a circular shape.

  As shown in FIG. 7, these protrusions 4 are arranged radially at equal angular intervals from the center of the insert 71 (the insert 7).

  As shown in FIG. 2, each protrusion 5 is formed (provided) so as to correspond to each of the four through holes 31 of the housing 6 in the assembled state. Further, the outer diameter of each protrusion 4 is slightly smaller than the inner diameter of the corresponding through hole 31.

  With such a protrusion 4, a gap (flow path 11) can be formed between the outer peripheral portion 43 of the protrusion 4 and the inner peripheral portion 311 of the through hole 31 in the assembled state.

  Moreover, as shown in FIG. 8, it is preferable that the inclined surface 42 is provided in a part of the front-end | tip part (top part) 41 of each projection part 4. As shown in FIG. The inclined surface 42 faces the outer peripheral side (radial direction) of the insert 7.

  By providing such an inclined surface 42, the contact area where the fingertip 400 contacts the insert 7 (chip 1) is increased, and thus blood 200 can be easily and reliably supplied to each flow path 11 in an assembled state. Can be introduced (see FIG. 11).

  As shown in FIG. 10, a nesting-side taper portion 72 is provided on the front end surface (front surface) of the nesting body 71.

  The inner diameter of the nesting-side taper portion 72 gradually increases in the protruding direction of the protruding portion 4, that is, in the distal direction. Moreover, as shown in FIG. 11, the nesting side taper part 72 is facing the housing side taper part 64 in the assembly state.

  In the assembled state, the gap 8 can be formed between the nesting-side taper portion 72 and the housing-side taper portion 64, so that the blood 200 that has passed through the flow path 11 passes through the gap 8 by capillary action and is nested. It is surely collected at the center of the main body 71 (test paper 5).

  Further, as shown in FIG. 12, the taper angle of the nesting side taper portion 72 (the angle indicated by β in FIG. 12) is the taper angle of the housing side taper portion 64 (the angle indicated by α in FIG. 12). It is set larger. As a result, the width of the gap 8 (the length indicated by w in FIG. 12) gradually decreases toward the central axis of the chip 1, that is, the gap 8 has a convergent shape. A capillary phenomenon appears prominently in the vicinity of the central portion 81. Therefore, the blood 200 that has passed through the flow path 11 can be reliably collected by the central portion of the nesting body 71.

  Further, since the gap 8 has a convergent shape, the flow rate of the blood 200 gradually increases as the blood 200 in the gap 8 moves toward (flows) toward the central portion 81. Thereby, the blood 200 can reach the test paper 5 quickly.

  The difference between the taper angle α and the taper angle β is not particularly limited, but is preferably, for example, 1 to 10 degrees, and more preferably 3 to 6 degrees.

  Further, a guide hole 73 penetrating the nesting body 71 is provided at the center of the nesting side taper portion 72 (nesting body 71). As described above, the guide pin 73 of the housing 6 is inserted into the guide hole 73 in the assembled state. At this time, the housing 6 and the insert 7 are accurately positioned so that the central axes of the housing 6 and the insert 7 substantially coincide (match).

  Thus, the guide pin 65 and the guide hole 73 function as blood introduction means for guiding the blood 200 to the test paper 5 in the assembled state.

  Further, the blood 200 in the gap 8 can reach the test paper 5 via the guide hole 73.

  On the base end surface (one surface) of the nesting body 71, a rib 74 for promoting blood expansion into the gap between the test paper 5 and the guide pin 65 is formed. As shown in FIG. 9, the rib 74 has a cross shape.

  The test paper 5 is fixed to the test paper fixing portion 68 by a method such as fusion or bonding with an adhesive, and comes into contact with the rib 74.

  In addition, four fan-shaped concave portions 75 formed toward the outer peripheral side by the ribs 74 are formed. The recess 75 has a function of assisting (promoting) the development of the blood 200 on the test paper 5. That is, the blood 200 flowing out from the guide hole 73 spreads radially through the recesses 75 by capillary action, so that the blood can be rapidly and uniformly developed on the test paper 5.

  Next, the shape, structure, material, etc. of the test paper 5 will be described.

  The overall shape of the test paper 5 is preferably a circle as shown in FIG. 9, but is not limited to this, and other examples include, for example, an ellipse, a square, a rectangle, a rectangle such as a diamond, a triangle, a hexagon, an octagon, etc. Can be selected and used as required.

  Such a test paper 5 is obtained by carrying (impregnating) a reagent (coloring reagent) on a carrier capable of absorbing the specimen (blood 200). This carrier is preferably composed of a porous sheet.

  By using a porous sheet carrier, when the reagent to be impregnated is a reagent system including a process using oxygen such as an oxidase reaction, sufficient supply of oxygen in the atmosphere after the specimen is developed on the test paper 5 Therefore, the reaction can proceed rapidly, and therefore, the color development state can be detected without removing the specimen 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.

  The material constituting the 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 the specimen. .

  Examples of the reagent carried on the test paper 5 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 200 components such as ascorbate oxidase, alcohol oxidase, cholesterol oxidase, etc., depending on the measurement components, Examples of the color former (coloring reagent) are the same as those described above. 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.

  Such a carrier made of a porous sheet preferably has a pore size that does not allow blood cells contained in blood 200, particularly red blood cells (hereinafter, represented by red blood cells) to pass through. Specifically, the pore diameter of the pores in the carrier is preferably about 0.05 to 2.0 μm, and more preferably about 0.1 to 0.5 μm. If the pore size is too small, the developability of the blood 200 is reduced, and if the pore size is too large, blood cells ooze out and the measurement sensitivity is lowered, and it is difficult for the drug to be carried and the coloration sensitivity is low. It becomes (it becomes difficult to color).

  Further, the test paper 5 may have not only a portion supporting the color reagent, but also a development layer composed of a conventionally known mesh or nonwoven fabric, a light reflection layer composed of titanium oxide fine particles, and the like.

  Next, the assembled chip 1 will be described.

  When the insert 7 is inserted into the lumen 67 from the base end side of the housing 6 and each projection 4 of the insert 7 is inserted into each through hole 31 of the housing 6, as shown in FIGS. Thus, the assembled chip 1 is obtained.

  As shown in FIG. 2, the chip 1 has a small, substantially cylindrical shape between the outer peripheral portion 43 of each protrusion 4 and the inner peripheral portion 311 of each through hole 31 into which the protrusion 4 is inserted ( However, an eccentric) gap is formed. In the chip 1, the gap is used as the flow path 11 for guiding the blood 200 to the test paper 5.

  As described above, in the chip 1, the flow path 11 is configured by a gap formed between two different members, that is, the housing 6 (through hole 31) and the insert 7 (projection 4). (Formed).

  By forming such a flow path 11, the blood 200 adhering to the chip 1 is surely transferred to the test paper 5 through the flow path 11 by capillary action even if it is a very small amount. Supplied. Furthermore, since the gap can be formed in a wide range, the blood 200 can be easily supplied to the test paper 5 in a wide range.

  Further, as shown in FIG. 11, in the chip 1, the top surface (tip) 411 of each protruding portion 4 protrudes from the through hole 31 of the housing 6. This prevents the inlet (opening) of the flow path 11 from being blocked when the tip portion 12 of the chip 1 is brought into contact (contact) with the surface of the finger 400 or the like in collecting the blood 200, The blood 200 can be smoothly and reliably supplied to the test paper 5.

  The top surface 411 of each protrusion 4 is located at a position lower than the top surface (tip) 32 of the center pole portion 3 and is located at a position higher than the top surface 621 of the lip portion 62. That is, the height of the top surface 32 of the center pole portion 3, the top surface 411 of each protrusion 4, and the top surface 621 of the lip portion 62 are reduced in this order.

  Due to the positional relationship (height relationship) between the top surfaces, the overall shape of the tip portion 12 of the tip 1 composed of the center pole portion 3, the respective protrusions 4, and the lip portion 62 is a gradual slope. Therefore, the outer diameter (average) on the distal end side of the chip 1 is smaller (thinner) than the outer diameter on the proximal end side. Accordingly, as shown in FIG. 11, when the chip 1 is attached (contacted) to the blood 200, the attachment position can be easily visually confirmed (confirmed), and thus the chip 1 can be attached accurately.

  As shown in FIG. 2, in the chip 1, the center of each protrusion 4 is closer to the center axis of the chip 1 (center pole part 3) than the center of the through hole 31 corresponding to each protrusion 4. Eccentric. Thereby, each channel 11 is set such that the width on the central axis side of the chip 1 is smaller than the width on the outer peripheral side of the chip 1.

  By such a channel 11, the capillary axis phenomenon appears preferentially on the central axis side of the chip 1 in the channel 11 compared to the outer peripheral side of the chip 1, so that the blood 200 that has passed through the channel 11 is removed from the test paper. It can be reliably collected by the central part of 5.

  Further, when the amount of blood 200 attached is small (a small amount), the blood 200 passes through the central axis side of the chip 1 in the flow path 11. When the amount of attached blood 200 is large, the blood 200 passes through the entire flow path 11. Thus, in any case, the blood 200 passes through the central axis side of the chip 1 in the flow path 11.

  Note that the chip 1 is configured such that the four protrusions 4 sandwich the center pole part 3 in the radial direction (center axis side of the chip 1), whereby each protrusion 4 and the corresponding through hole 31 are provided. Can be reliably eccentric.

  Further, in the chip 1, it is preferable that the housing 6 and the insert 7 are fixed to each other by adhesion or fusion. This prevents the nesting 7 from unintentionally leaving the housing 6.

  Further, the constituent materials of the housing 6 and the insert 7 may be the same or different.

  When the same constituent material is used, the number of constituent materials to be used is reduced, and thus the manufacturing cost can be suppressed.

  When different constituent materials are used, for example, materials suitable for molding the housing 6 and the insert 7 can be used.

  Further, it is preferable that at least one of the outer peripheral portion 43 of the protrusion 4 and the inner peripheral portion 311 of the through hole 31 is subjected to a hydrophilic treatment. As a result, the blood 200 is rapidly (reliably) introduced into the flow path 11, and thus can be reliably reached by the test paper 5.

  In the chip 1, since the chip body 2 is composed of two members of the housing 6 and the insert 7, the outer peripheral portion 43 of the protruding portion 4 and the inner peripheral portion 311 of the through hole 31 can be easily subjected to a hydrophilic treatment. it can.

  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.).

  The chip 1 described above is used by being mounted on the chip mounting portion 101 of the component measuring apparatus (blood component measuring apparatus) 100. Here, the component measuring apparatus 100 will be briefly described.

  The component measuring apparatus 100 has a chip mounting part 101. The chip mounting part 101 has a cylindrical shape, and the chip 1 is detachably mounted at the tip thereof.

  Near the inner side of the chip mounting portion 101, a photometric unit (not shown) having a light emitting element (light emitting diode) and a light receiving element (photodiode) is provided. For example, the light emitting element emits pulsed light at a predetermined time interval.

  Moreover, the component measuring apparatus 100 has a control means (not shown) comprised with a microcomputer. This control means incorporates a calculation unit that calculates a target blood component (for example, glucose) based on a signal from the photometry unit.

  The chip 1 is mounted on the chip mounting portion 101, and the sample is supplied to and spread on the test paper 5 of the chip 1 as described later, and then measurement is performed. When the light emitting element is turned on, the light emitted from the light emitting element is applied to the test paper 5 of the chip 1 to obtain the reflected light. The intensity of the reflected light corresponds to the color intensity of the test paper 5, that is, the amount (concentration) of the target component in the specimen. This reflected light is received by the light receiving element and subjected to photoelectric conversion. From the light receiving element, an analog signal corresponding to the amount of received light is output, 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 the amount of target component in the sample Is quantified (blood glucose level is determined).

  In the chip mounting state, the test paper 5 is not in contact with the chip mounting portion 101 (see FIG. 11). Therefore, the test paper 5 is protected, and the test paper 5 is prevented from being scratched or torn, and the test paper 5 comes into contact with the chip mounting portion 101 and the blood 200 adheres to the chip mounting portion 101 and is contaminated. Is prevented.

  Next, a method for using the component measuring apparatus 100 with the chip mounted will be described with reference to FIG.

  First, a fingertip 400 (or earlobe) or the like is punctured with a needle, a scalpel, or the like, and a small amount (for example, 1 μL or less) of blood 200 flows out (discharges) from the puncture portion onto the skin.

  On the other hand, the chip 1 is mounted on the chip mounting portion 101 of the component measuring apparatus 100, and the tip 12 of the chip 1 is brought into contact with the skin. The blood 200 of the fingertip 400 reaches the flow path 11, is sucked by capillary action, flows in the proximal direction in the flow path 11, and reaches (absorbs) the test paper 5 through (via) the gap 8. . At this time, the blood 200 of the fingertip 400 is effectively inhaled into the flow path 11, so that it is not excessively scattered on the skin and has little loss. Moreover, since the flow path 11 is open in a wide range, the allowable range of the spotting position of the blood 200 is large and the spotting is easy.

  Thus, even when the amount of blood 200 in the fingertip 400 is relatively small (a small amount), it can be supplied to the test paper 5 without waste. That is, even when the amount of blood 200 in the fingertip 400 is relatively small, the blood 200 can be reliably collected.

  As the blood 200 is supplied onto the test paper 5, the target component (for example, glucose) in the blood reacts with the reagent carried on the test paper 5 and colors according to the amount of the target component.

  By measuring the color intensity of the test paper 5 optically with the component measuring device (blood component measuring device) 100 as described above, the target component amount (blood glucose level) in the blood can be obtained.

  After the measurement is completed, the pin 104 built in the chip mounting unit 101 is slid in the distal direction, the base end of the housing 6 of the chip 1 is pressed with the tip of the pin 104, and the chip 1 is removed from the chip mounting unit 101. The removed used chip 1 is subjected to disposal.

  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.

  Further, the chip body is not limited to being constituted by two different members, that is, a housing and a nesting, but may be constituted so as to integrate them. When the housing and the insert are integrated, the flow path is directly formed in the chip body.

  Further, the number of through-holes and nest protrusions formed in the housing is not limited to four, and may be one, two, three, five, or more, for example.

  Moreover, you may provide the convex part provided in the housing side taper part in the nesting side taper part. Moreover, it may replace with such a convex part and may provide a recessed part.

  Moreover, it is preferable that at least one of the outer peripheral portion of the protrusion and the inner peripheral portion of the through hole is subjected to a hydrophilic treatment, but instead of this hydrophilic treatment, the outer peripheral portion of the protrusion and the through hole A highly hydrophilic material such as an acrylic resin may be used for the inner peripheral portion.

  The component measuring chip of the present invention includes a housing having a tip portion for contacting the skin, a through-hole opening in the tip portion, a test paper capable of absorbing a sample on one side, and the test paper. A component measuring chip configured by combining a nesting main body and a nesting formed on the nesting main body and having a protrusion inserted into the through hole, wherein the protrusion of the nesting is formed on the housing. A gap formed between the outer peripheral portion of the protrusion and the inner peripheral portion of the through hole in a state of being inserted into the through hole is used as a flow path for guiding the specimen to the test paper. Therefore, by forming a narrow channel in a wide range, even a very small amount of sample can be reliably collected. Therefore, the component measuring chip of the present invention has industrial applicability.

Claims (8)

A housing having a tip for contacting the skin, and a through-hole opening in the tip;
A test paper that can absorb the specimen on one side, a nesting body that comes into contact with the test paper, and a nesting that is formed on the nesting body and has a protrusion inserted into the through hole. A component measuring chip,
In order to guide the specimen to the test paper, a gap formed between the outer periphery of the protrusion and the inner periphery of the through hole in a state in which the protrusion of the insert is inserted into the through hole of the housing. A component measuring chip, characterized in that it is used as a flow path. 2. The component measuring chip according to claim 1, wherein the tip portion has a center pole portion protruding and formed in a mountain shape, and the through-hole is opened around or around the center pole portion. In the housing, a plurality of the through holes are arranged radially from the center of the housing,
The component measuring chip according to claim 1, wherein a plurality of the protrusions are arranged radially from the center of the nest. 4. The component measuring chip according to claim 3, wherein the center of each projection is eccentric with respect to the center of each through hole in a state where the housing and the insert are combined. 2. The component measuring chip according to claim 1, further comprising means for collecting the specimen that has passed through the flow path at a central portion of the test paper. On the back surface of the housing, a housing-side taper portion whose outer diameter gradually decreases in a direction opposite to the protruding direction of the tip portion is provided,
A surface of the nesting body is provided with a nesting side taper portion whose inner diameter gradually increases in the protruding direction of the protrusion, and in a state where the housing and the nesting are combined, the housing side taper portion and The component measuring chip according to claim 1, wherein the nesting side taper portion faces each other. A chip body;
A center pole formed to project in a mountain shape at the tip of the chip body;
A channel formed around or on the slope of the center pole portion, through which the specimen can pass,
A component measuring chip comprising a test paper capable of absorbing the specimen and installed on the back side of the chip body. 8. The component measuring chip according to claim 7, wherein the flow path is constituted by a gap formed by combining two different members.

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