JP2012127925A - Chip for analyzing liquid to be inspected - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a chip for analyzing a liquid to be inspected having a devised shape for improving productive efficiency.SOLUTION: A chip 100 for analyzing a liquid to be inspected having a substantially long shape in a plan view, comprises: a contact port 2 with which a liquid to be inspected is brought into contact; an analysis part 3 for analyzing the liquid to be inspected; and a transporting path 4 communicated with the contact port 2 and the analysis part 3 for transporting the liquid to be inspected to the analysis part 3 through capillarity. The contact port 2 is formed in a projection 101 projecting outward in a plan view on one longitudinal side 1a, and a recess 102 in a shape corresponding to the projection 101 in a plan view is formed on the other longitudinal side 1b.

Description

  The present invention relates to a test liquid analysis chip for analyzing a test liquid.

  As a conventional test liquid analysis chip, as shown in Patent Document 1, a plan view generally long shape having a protrusion shape on a part of a side surface, a contact port with which blood as a test liquid contacts, and blood And a transfer path that communicates the contact port and the analysis unit and transfers blood to the analysis unit by capillary action. The analysis unit is for bringing non-blood cell components such as plasma and serum other than blood cells from blood transferred by a transfer path into contact with an external sensor, an analysis opening communicating with the outside, and the analysis And a separation membrane that is provided in the opening and separates and passes plasma and serum from the blood.

  And in this test solution analysis chip, as shown in FIGS. 3 and 9 of Patent Document 1, the contact port is formed in a protrusion formed on the long side portion, and blood such as a finger is provided. The part is configured to easily come into contact with the contact port.

  Here, when manufacturing the above-mentioned test liquid analysis chip, after laminating various sheets constituting the test liquid analysis chip, it is punched out with a mold having a plan view shape of the test liquid analysis chip By processing, each test solution analysis chip is created.

  However, in the conventional test liquid analysis chip, as described above, the protrusions with the contact holes formed on the long side portions are printed on the multi-sided sheet. In this case, it is necessary to separate the test solution analysis chips adjacent to each other at least as much as the protrusions of the protrusions. Then, there is a problem that the number of test solution analysis chips punched out from one multi-chamfered sheet having a predetermined area is limited, and it is difficult to improve production efficiency.

JP 2009-175118 A

  Accordingly, the main purpose of the present invention is to improve the production efficiency of the test liquid analysis chip by devising the shape of the test liquid analysis chip.

  That is, the test liquid analysis chip according to the present invention is a test liquid analysis chip for analyzing a test liquid, and has a substantially long shape in plan view, and is in contact with the test liquid. A mouth, an analysis unit for analyzing the test solution, and a transfer path that communicates the contact port and the analysis unit to transfer the test solution to the analysis unit by capillary action, and the contact port is It is formed in a projection protruding outward in plan view on one longitudinal side, and a recess having a shape corresponding to the projection in plan view is formed on the other longitudinal side. To do. The analysis unit may have a configuration in which a sensor is provided, or a configuration in which a test solution is analyzed by contact with a sensor outside the chip.

  If this is the case, a plurality of test solution analysis chips are formed by forming recesses in the other long side portion so as to correspond to the protrusions formed in one long side portion. Can be made as close as possible to adjacent test solution analysis chips. As a result, as many test solution analysis chips as possible can be created from one multi-chamfered sheet having a predetermined area, and the production efficiency can be improved.

  In order to make adjacent test solution analysis chips as close as possible to each other in one multi-sided sheet, or to make a part or all of them contact and continue, the one long side portion and the other side It is desirable that the longitudinal side portion is substantially linear in plan view, and the contour shape of the concave portion in plan view is substantially the same as the contour shape of the protrusion in plan view. Here, it is particularly desirable that the contour shape in plan view of the one long side portion is substantially the same as the contour shape in plan view of the other long side portion. If this is the case, a plurality of test solution analysis chips can be brought into contact with each other in the short-side direction in the multi-chamfer sheet. As a result, after one test liquid analysis chip is punched, a part of the punched surface also serves as the longitudinal side of another adjacent test liquid analysis chip. Specifically, the punched surface of the other longitudinal side portion of one test solution analysis chip is one longitudinal side portion of another adjacent test solution analysis chip. Moreover, the waste sheet material after processing can be reduced as much as possible by bringing adjacent chips into contact with each other in the multi-chamfer sheet.

  In addition, in order to prevent the reverse insertion of the test liquid analysis chip without reducing the production efficiency of the test liquid analysis chip, it is opposite to the longitudinal tip inserted into the measuring instrument. At the rear end portion in the longitudinal direction on the side, an erroneous insertion prevention convex portion is formed on at least one of the one longitudinal side portion or the other longitudinal side portion, and the erroneous insertion prevention convex portion is formed. It is desirable that a second concave portion having a shape corresponding to the erroneous insertion preventing convex portion is formed on the long side portion opposite to the formed long side portion.

  At this time, in order to create as many test solution analysis chips having erroneous insertion prevention convex portions as possible from one multi-faced sheet having a predetermined area, the contour shape of the second concave portion in plan view is It is desirable that the erroneous insertion preventing convex portion has substantially the same contour shape as seen in plan view.

  According to the present invention configured as described above, the production efficiency can be improved by devising the shape of the test liquid analysis chip.

The figure which shows the test | inspection liquid analysis chip | tip and concentration measuring apparatus of this embodiment. The perspective view of the test liquid analysis chip of the embodiment. FIG. 6 is a six-side view of the test liquid analysis chip of the same embodiment. FIG. 2 is a schematic cross-sectional view showing an internal configuration of a test liquid analysis chip. The figure which shows the outline shape of a test liquid analysis chip | tip. The top view which shows the lower board | substrate sheet | seat which comprises a multi-sided sheet | seat. The top view which shows the intermediate | middle board | substrate sheet | seat which comprises a multi-sided sheet | seat. The top view which shows the upper board | substrate sheet | seat which comprises a multi-sided sheet | seat. The top view which shows the multiple chamfering sheet | seat of the test solution analysis chip | tip. The figure which shows the punching process of a multi-chamfer sheet | seat. The top view which shows the modification of a multi-surface sheet.

  The test solution analysis chip 100 according to the present embodiment is used in a concentration measuring device Z using an electrode sensor Z3.

  The concentration measuring device Z measures, for example, a blood glucose level in blood. As shown in FIG. 1, the concentration measuring device Z is inserted into the insertion port Z1 into which the test liquid analysis chip 100 is inserted, and inserted into the insertion port Z1. A positioning mechanism Z2 that positions the test solution analysis chip 100, an enzyme electrode sensor Z3 that moves forward and backward relative to the positioned test solution analysis chip 100, and a measurement voltage for the enzyme electrode sensor Z3. The measurement power supply Z4 to be applied, the current detection unit Z5 for detecting the current output from the enzyme electrode sensor Z3, and the measurement power supply Z4 are controlled, the detected current is differentiated, and the maximum value of the differential value is obtained. And a calculation unit Z6 for detecting and calculating the concentration of the measurement target substance in the test liquid. The enzyme electrode sensor Z3 includes a platinum (Pt) electrode at the tip, and a glucose oxidase (GOD) immobilization film is coated on the surface thereof.

  Specifically, as shown in FIGS. 2 and 3, the test liquid analysis chip 100 has a substantially long shape in plan view, and is provided on a test liquid supply site (blood supply site, such as a finger). A contact port 2 that comes into contact with blood, an analysis unit 3 for analyzing blood, and a transfer path 4 that communicates the contact port 2 and the analysis unit 3 to transfer blood to the analysis unit 3 by capillary action. It comprises. The test solution analysis chip 100 includes a positioning hole 5 into which a pin or the like of the positioning mechanism Z2 is inserted when positioning to the concentration measuring device Z.

  As shown in FIG. 3 in particular, the test solution analysis chip 100 has a pair of longitudinal side portions 1a and 1b that are substantially linear in a plan view. The pair of longitudinal side portions 1a and 1b are formed substantially parallel to the longitudinal central axis C. Further, a grip 6 for operating the test solution analysis chip 100 is provided at the longitudinal rear end 1d opposite to the longitudinal tip 1c inserted into the concentration measuring device Z as a measuring instrument. Is formed. In the following, the left long side portion facing the front end in the longitudinal direction is referred to as one long side portion 1a, and the right long side portion is referred to as the other long side portion 1b.

  The contact port 2 is formed in a protrusion 101 that protrudes outward in plan view at one longitudinal side 1a, and specifically faces outward in the vicinity of the topmost part (outermost part) of the protrusion 101 in plan view. Is formed. The protrusion 101 is provided so as to extend in a direction orthogonal to the longitudinal central axis C, and the contour shape of the protrusion 101 in a plan view is formed so as to form a curved shape bulging outward. .

  As shown in FIGS. 3 and 4, the analysis unit 3 is for bringing non-blood cell components such as plasma and serum other than blood cells from the blood transferred by the transfer path 4 into contact with the enzyme electrode sensor Z3. A test liquid storage section 31 provided on the upstream side of the air hole 7 in the transfer path 4 and whose flow path width is widened, and an analysis opening communicating with the outside on the side wall forming the test liquid storage section 31 32 and a separation membrane 33 that is provided in the analysis opening 32 and separates plasma and serum, which are measurement target substances, from blood and passes through the analysis opening 32. The air hole 7 discharges air accompanying the introduction of blood.

  As shown in FIG. 4, the analysis opening 32 is formed on the surface (lower surface) opposite to the surface (upper surface) where the air holes 7 are formed. The enzyme electrode sensor Z3 is in contact with the analysis opening 32.

  The separation membrane 33 is, for example, a polyethylene terephthalate (PET) membrane having a large number of micropores through which non-blood cell components such as plasma and serum other than blood cells pass from the blood. In addition, a polycarbonate membrane or the like may be used as the separation membrane 33.

  As shown in FIGS. 3 and 4, the transfer path 4 communicates with the contact port 2 and the analysis unit 3, and extends to the downstream side of the analysis unit 3, and the air hole 7 is provided downstream of the analysis unit 3. Is formed. Specifically, the transfer path 4 is formed to extend from the contact port 2 toward the longitudinal tip 1c.

  Thus, as shown in FIGS. 3 and 5, the test solution analysis chip 100 of the present embodiment has a first recess 102 having a shape corresponding to the protrusion 101 in plan view on the other longitudinal side 1b. Is formed. Here, the protrusion 101 and the corresponding first recess 102 are formed at symmetrical positions in the longitudinal direction with respect to the central axis C in the longitudinal direction in the test solution analyzing chip 100.

  Specifically, the contour shape of the first recess 102 in plan view is substantially the same as the contour shape of the protrusion 101 in plan view. In the present embodiment, the contour shape of the first recess 102 in plan view is a curved shape curved inward, and is formed so as to match the contour shape of the projection 101 in plan view.

  In addition, in the rear end portion 1d in the longitudinal direction of the test solution analysis chip 100, at least one of the one long side portion 1a or the other long side portion 1b is prevented from being erroneously inserted into the measuring instrument Z. Is formed. In the present embodiment, the grip portion 6 is formed on the other long side portion 1b. The erroneous insertion preventing convex portion 103 is formed by a convex portion that protrudes outward in plan view in the other long side portion 1b, and the contour shape in plan view forms a curved shape that bulges outward. Is formed.

  A second concave portion 104 having a shape corresponding to the erroneous insertion preventing convex portion 103 is formed on one longitudinal side portion 1a of the longitudinal rear end portion 1d. Here, the erroneous insertion preventing convex portion 103 and the corresponding second concave portion 104 are formed at symmetrical positions in the longitudinal direction with respect to the longitudinal central axis C1 in the test solution analyzing chip 100.

  Specifically, the contour shape of the second recess 104 in a plan view and the contour shape of the erroneous insertion prevention convex portion 103 in a plan view are substantially the same. In the present embodiment, the contour shape of the second recess 104 in plan view is formed so as to coincide with at least part of the contour shape of the projection 101 in plan view. Since the erroneous insertion preventing convex portion 103 and the second concave portion 104 are thus formed at the longitudinal rear end portion 1d of the chip 100, the central axis C1 of the longitudinal rear end portion 1d of the chip is the longitudinal length of the entire chip. It is slightly inclined from the direction center axis C.

  By configuring in this way, the contour shape in plan view of the substantially entire one longitudinal side portion 1a of the test solution analysis chip 100 is substantially the same as the contour shape in plan view of the substantially entire other longitudinal side portion 1b. It is configured to be substantially the same as the whole. That is, the test liquid analysis chip 100 is configured such that the width in the direction orthogonal to the longitudinal direction is substantially the same throughout.

  Note that the third recess 105 formed in one longitudinal side portion 1a of the distal end portion 1c in the longitudinal direction of the test solution analysis chip 100 is formed for positioning by the positioning mechanism Z2 of the measuring instrument Z. The fourth recess 106 formed in the other longitudinal side 1b at the longitudinal tip 1c is a processing recess formed by a first punching process described later. These parts are exceptionally different in width from the other parts.

  Next, a method of manufacturing the test solution analyzing chip 100 configured as described above will be described with reference to FIGS.

  As shown in FIG. 4, the test solution analysis chip 100 of this embodiment has a three-layer structure including a lower substrate 100a, an intermediate substrate 100b, and an upper substrate 100c. The lower substrate 100a and the intermediate substrate 100b, and the intermediate substrate 100b and the upper substrate 100c are bonded to each other.

  Then, the test solution analyzing chip 100 forms a lower substrate sheet S1 that forms the lower substrate 100a, an intermediate substrate sheet S2 that forms the intermediate substrate 100b, and an upper substrate 100c, as shown in FIGS. The multi-chamfered sheet S (see FIG. 9) formed by laminating the upper substrate sheet S3 is created by cutting out by punching or the like.

  As shown in FIG. 6, the lower substrate sheet S1 has a substantially rectangular plate shape and is a resin sheet having hydrophilicity on the surface. In this embodiment, it comprises by carrying out hydrophilic coating on the surface of resin-made sheets, such as PET and an acryl. In addition, what added hydrophilicity by plasma processing may be used. In addition, the back surface is water-repellent.

  The lower substrate sheet S1 has, after punching, a through hole S11 that constitutes the positioning hole 5 of the test solution analysis chip 100, a through hole S12 that constitutes the analysis opening 32, and the contact hole 2. A through hole S13 is formed to open the chip below and increase the opening size. These through-holes S11 to S13 are formed by pressing corresponding to the punched portions of the test solution analysis chip 100, respectively. In addition, the through-hole S14 formed in the four corners of the sheet S1 is a positioning hole for bonding for positioning the sheets S1 to S3.

  As shown in FIG. 7, the intermediate substrate sheet S <b> 2 has a substantially rectangular plate shape, and is composed of a double-sided tape in which a base material is made of a resin such as PET, and an acrylic adhesive is applied to the front and back surfaces thereof. Yes.

  The intermediate substrate sheet S2 has a through-hole S21 that constitutes the positioning hole 5 of the test liquid analysis chip 100, the contact port 2 of the test liquid analysis chip 100, and a test liquid storage section after punching. 31, a slit-like through-hole S <b> 22 constituting the transfer path 4 is formed. These through holes S21 and S22 are formed by pressing corresponding to the punched portions of the test liquid analysis chip 100, respectively. In addition, the through-holes S23 formed at the four corners of the sheet S2 are bonding positioning holes for positioning the sheets S1 to S3.

  As shown in FIG. 8, the upper substrate sheet S3 is a resin sheet having a substantially rectangular plate shape and hydrophilic on the back surface. The upper substrate sheet S3 of the present embodiment is configured such that a sheet for imparting rigidity is further bonded to the surface of a hydrophilic sheet on the back surface.

  The upper substrate sheet S3 is formed with a through hole S31 constituting the positioning hole 5 of the test solution analyzing chip 100 and a through hole S32 constituting the air hole 7 after punching. These through holes S31 and S32 are formed by pressing corresponding to the punched portions of the test solution analysis chip 100, respectively. In addition, the through-hole S33 formed in the four corners of the sheet S3 is a positioning hole for bonding for positioning the sheets S1 to S3.

  Then, the lower substrate sheet S1, the intermediate substrate sheet S2, and the upper substrate sheet S3 are bonded together using bonding positioning holes S14, S23, and S33. Then, as shown in FIG. 9, a plurality (five) of the test solution analysis chips 100 are in a state of being aligned in parallel on the left and right sides in a contact state. In addition, the analysis part 3, the transfer path 4, etc. are formed in each chip | tip punching location for test liquid analysis.

  The multi-cavity sheet S configured in this manner is punched out according to the following procedure to create a test liquid analysis chip 100 (see FIG. 10).

  First, the positioning hole 5 is formed in the front-end | tip part of the longitudinal direction of the test liquid analysis chip | tip 100 in the multiple chamfering sheet S obtained by the above (1st punching process).

  Then, after the first punching process is completed, a second punching process is performed. In the second punching process, the test liquid analysis chip 100 is punched out by skipping one of the test liquid analysis chip punching sites printed on the multi-chamfered sheet S. In this embodiment, since the odd-numbered (five) test liquid analysis chip punched portions are set and printed on the multi-surface sheet S, the test liquid analysis chips 100 on both sides and one of them are skipped. The test solution analysis chip 100 (intermediate test solution analysis chip 100) is punched out. At this time, the chips 100 may be punched one by one, or a die that can be punched one by one may be prepared and punched at once using this die.

  Further, in the second punching process, a part of the through hole S13 formed in the lower substrate sheet S1 and a part corresponding to the through hole S13 in the through hole S22 formed in the intermediate substrate sheet S2 are cut. One contact port 2 is formed. At this time, a side opening portion is formed by the through hole S22 formed in the intermediate substrate sheet S2, and a downward opening portion is formed by the through hole S13 formed in the lower substrate sheet S1.

  The blade portion on the left side in the longitudinal direction of the mold used at this time cuts the left side portion 1a on the left side of the chip 100, and when there is a chip punching place on the left side of the chip 100, the right side of the chip 100 The long side portion 1b is cut. Further, the right side blade portion of the mold in the longitudinal direction cuts the right side portion 1b on the right side of the chip 100, and when there is a chip punching site on the right side of the chip, the left side longitudinal portion of the chip 100 The side part 1a is cut.

  As a result of this second punching process, the chip 100 with the longitudinal end portions 1c and 1d connected to the multi-chamfered sheet S remains on the multi-chamfered sheet S. Contour portions other than the longitudinal end portions 1c and 1d form the contour shape of the chip 100 after punching.

  In the third punching process, the chip 100 remaining on the multi-chamfered sheet S is punched. The cutting edge of the mold used at this time coincides with the contour shape of the longitudinal end portions 1c and 1d connected to the multi-chamfered sheet S of the chip 100, and other parts do not contact the multi-chamfered sheet S. It is composed of. As a result, the remaining test solution analysis chip 100 is punched from the multi-chamfered sheet S.

  Thus, the test liquid analysis chip 100 obtained by the second punching process and the third punching process has substantially the same shape in plan view.

<Effect of this embodiment>
According to the test solution analysis chip 100 according to the present embodiment configured as described above, a concave portion is formed in the other long side portion 1b so as to correspond to the protrusion portion 101 formed in one long side portion 1a. By forming 102, when a plurality of test solution analysis chips 100 are taken from a single sheet S, the adjacent test solution analysis chips 100 can be made as close as possible. As a result, as many test solution analysis chips 100 as possible can be created from one multi-chamfered sheet S having a predetermined area, and the production efficiency can be improved.

  In particular, in the present embodiment, since a plurality of test solution analysis chip punched portions are continuously formed in the multi-sided sheet S, a maximum number of test solutions can be obtained from one multi-sided sheet S having a predetermined area. The analysis chip 100 can be created.

<Other modified embodiments>
The present invention is not limited to the above embodiment.

  For example, in the above-described embodiment, the test solution analysis chips adjacent to each other in the multi-surface sheet are configured so as to be in contact with each other, but as illustrated in FIG. You may arrange as follows. This also makes it possible to increase the number of chips that can be created from a single multi-sheet.

  In addition, as a plan view outline shape of the protrusion, in addition to a curved shape bulging outward, a polygonal shape such as a substantially triangular shape or a substantially rectangular shape, or a partial arc shape or a partial ellipse shape It may be. At this time, a 1st recessed part is made into the shape corresponding to the projection part which makes each shape.

  Moreover, in the said embodiment, although the holding part and the erroneous insertion prevention convex part are formed and formed in the same site | part, you may form a grip part and an erroneous insertion prevention convex part in a mutually different place. For example, the grip portion may be provided at the rear end portion in the longitudinal direction, and the erroneous insertion prevention convex portion may be formed on the longitudinal side portion on the tip side of the grip portion.

  Further, the test liquid analysis chip of the above embodiment was inserted into a measuring instrument for analysis. However, a test reagent introduced into the analysis unit in the chip was applied through a transfer path. You may analyze a to-be-tested liquid part by seeing reaction with a liquid and a reaction reagent.

  In addition, in the above-described embodiment, the test solution analysis chip has a substantially long shape in plan view extending in the longitudinal direction, and the longitudinal central axis is linear, but the longitudinal central axis is slightly It may be curved.

  In addition, in the above-described embodiment, the protrusion and the recess of the test solution analysis chip are formed at symmetrical positions with respect to the central axis in the longitudinal direction, but may be formed at different positions in the longitudinal direction.

  In addition, in the above-described embodiment, the test solution analysis chip punching portions are formed in the left and right rows on the multi-surface sheet, but a plurality of rows may be formed vertically.

  In addition, it goes without saying that the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

100 ... Chip for analysis of test solution Z ... Concentration measuring device (measuring instrument)
2 ・ ・ ・ Contact 3 ・ ・ ・ Analyzing unit 4 ・ ・ ・ Transfer path 1 a ・ ・ ・ One longitudinal side portion 101 ・ ・ ・ Protrusion portion 1 b ・ ・ ・ The other longitudinal side portion 102 ・ ・ ・ First Recess (recess)
1c: Longitudinal front end 1d: Longitudinal rear end 103: Misinsertion preventing convex 104: Second concave

Claims (4)

A test liquid analysis chip for analyzing a test liquid,
It has an elongated shape in plan view, and has a contact port with which a test solution comes into contact, an analysis unit for analyzing the test solution, and the contact port and the analysis unit that communicate with each other by capillary action. A transfer path for transferring the test solution to the analysis unit,
The contact hole is formed in a protrusion protruding outward in plan view at one longitudinal side, and a recess having a shape corresponding to the protrusion in plan view is formed in the other longitudinal side. A test liquid analysis chip characterized by comprising:   The test liquid analysis chip according to claim 1, wherein a contour shape in plan view of the one long side portion is substantially the same as a contour shape in plan view of the other long side portion.   At the rear end in the longitudinal direction opposite to the longitudinal tip inserted into the measuring instrument, at least one of the one longitudinal side or the other longitudinal side is prevented from erroneous insertion into the measuring instrument. And a second concave portion having a shape corresponding to the erroneous insertion prevention convex portion is formed on the longitudinal side portion opposite to the longitudinal side portion on which the erroneous insertion prevention convex portion is formed. The test solution analysis chip according to claim 1 or 2.   The test liquid analysis chip according to claim 3, wherein a contour shape of the second concave portion in plan view is substantially the same as a contour shape of the erroneous insertion preventing convex portion in plan view.