JP4852029B2 - Test solution analysis chip - Google Patents

Description

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

  An example of this type of test solution analysis chip is disclosed in Patent Document 1. Specifically, this is a test liquid analysis chip having a rectangular plate shape, and a sample introduction port (contact port) is formed on a side surface thereof. When blood is brought into contact with the sample introduction port, blood flows into the flow path communicating with the sample introduction port by capillary action.

However, when blood is brought into contact with the sample introduction port, there is a problem that blood not only flows into the flow path but also spreads along the side surface where the sample introduction port is formed. If it does so, when moving a chip | tip etc. after blood collection, there exists a problem that an operator's hand will be soiled or the circumference | surroundings will be soiled. Furthermore, when the chip is inserted into the measuring instrument for analysis, there is a problem that the operator touches the operator's hand at the time of insertion, and the inside of the measuring instrument is soiled.
International Publication No. 2004/113927 Pamphlet

  Therefore, the present invention has been made to solve the above problems all at once, and its main purpose is to prevent external contamination by the test liquid adhering to the contact port and its vicinity after the test liquid is collected. It is intended.

  That is, the test liquid analysis chip according to the present invention is a test liquid analysis chip for analyzing a test liquid, and is in communication with the contact port in contact with the test liquid, and the contact port, A chip main body having an introduction path for introducing a test solution into the inside by capillary action, and provided rotatably on the chip main body. The contact opening is opened and extended in a folded state with respect to the chip main body. And an opening / closing body that covers and closes the contact opening in a state.

  In such a case, after the sample liquid is collected, the contact opening can be covered and closed by extending the opening / closing body with respect to the chip body. The test solution can prevent external contamination of workers and devices.

  In order to simplify the configuration of the test liquid analysis chip, it is desirable that the opening / closing body is rotatably provided on a part of the side surface on which the contact port is formed.

  In order to further prevent contamination to the outside, it is desirable that the opening / closing body covers the entire side surface in which the contact hole is formed in a state of extending to the chip body.

  An opening that is provided in a part of the introduction path and communicates with the introduction path and the outside, and is in contact with an electrode sensor for analyzing a measurement target substance in the test liquid; and provided in the opening. A separation membrane that separates a measurement target substance from the test solution and passes the opening, and the opening / closing body covers the opening in a state of being folded with respect to the chip body. It is desirable that it is a blockage. In this case, when the opening / closing body is folded with respect to the chip body, the opening is closed, and the contact between the separation membrane and the outside can be blocked to prevent the separation membrane from being damaged. On the other hand, in the state where the opening / closing body extends with respect to the chip body, the contact port is closed, and external contamination by the test liquid adhering to the contact port and the vicinity thereof is prevented, and the opening is opened so that the electrode sensor It becomes possible to measure in contact.

  As described above, according to the present invention, it is possible to prevent external contamination due to the test solution adhering to the contact port and the vicinity thereof after the sample solution is collected.

  Next, an embodiment of a test liquid analysis chip 1 according to the present invention will be described with reference to the drawings. 1 is a diagram showing a test liquid analysis chip 1 and a concentration measuring device Z according to the present embodiment, FIG. 2 is a perspective view (folded state) of the test liquid analysis chip 1, and FIG. FIG. 4 is a plan view of the test liquid analysis chip 1, FIG. 5 is a cross-sectional view taken along line AA, and FIG. 6 is an exploded view of the test liquid analysis chip 1. It is a perspective view.

  <Device configuration>

  The test liquid analysis chip 1 according to the present embodiment is used for a concentration measuring device Z using an electrode sensor Z3.

  The concentration measuring device Z measures, for example, 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 1 is inserted, and inserted into the insertion port Z1. A positioning mechanism Z2 for positioning the test liquid analysis chip 1, an enzyme electrode sensor Z3 that moves forward and backward with respect to the positioned test liquid analysis chip 1, 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 FIG. 2 to FIG. 5, the test solution analysis chip 1 has a substantially rectangular plate shape that can be folded, and is connected to the chip body 2 and the chip body 2. An opening / closing body 3 provided to be rotatable with respect to the main body 2 is provided.

  The chip body 2 includes a contact port 2A that is in contact with blood as a test solution, an introduction channel 2B that communicates with the contact port 2A and introduces blood into the inside by capillary action, and a terminal end of the introduction channel 2B. 2C provided between the air hole 2C that discharges air accompanying the introduction of blood and the contact port 2A and the air hole 2C in the introduction path 2B, and communicates the introduction path 2B with the outside. An opening 2D with which the sensor Z3 comes into contact; a separation membrane 2E which is provided in the introduction path 2B side opening of the opening 2D and separates plasma and serum, which are substances to be measured, from blood and passes through the opening 2D It has.

  Further, as shown particularly in FIG. 4 and the like, the introduction channel 2B is formed with a test liquid storage portion 2F whose channel width is expanded between the contact port 2A and the air hole 2C. And the opening part 2D is formed in the side wall which forms this test liquid storage part 2F (refer FIG. 5). The test liquid analysis chip 1 includes a positioning hole (not shown) 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 FIGS. 2, 3, and 5, the opening / closing body 3 is rotatably connected to a part of the side surface 201 in which the contact port 2 </ b> A is formed, in this embodiment, one side of the side surface 201. In a state of being folded with respect to 2, the contact opening 2A is opened and the opening 2D is covered and closed (see FIG. 2). On the other hand, the opening / closing body 3 covers and closes the contact opening 2A and opens the opening 2D in a state of extending with respect to the chip body 2 (see FIG. 3).

  Specifically, the opening / closing body 3 covers a range in which blood that contacts the contact port 2A spreads along the side surface 201 in a state of extending with respect to the chip body 2, and in this embodiment, the contact port 2A. It covers the entire side surface 201 on which is formed. Further, the opening / closing body 3 functions as a holding portion when the chip body 2 is inserted into the device Z in a state of being extended with respect to the chip body 2, thereby facilitating the insertion operation.

  Further, in the state where the opening / closing body 3 is folded with respect to the chip body 2, the thickness of the test liquid analysis chip 1 is larger than the insertion port Z <b> 1 of the concentration measuring device Z. Thereby, it can prevent inserting in the insertion port Z1 in the folded state, As a result, external contamination, such as an operator and the apparatus Z, can be prevented.

  The test liquid analysis chip 1 according to this embodiment includes a main body substrate 11 and a cover substrate 12. Hereinafter, each part will be described together with the description of the main body substrate 11 and the cover substrate 12.

  As shown in FIGS. 2, 3 and 5, the main body substrate 11 is a substrate in which a chip main body side substrate 111 and an opening / closing body side substrate 112 are connected, and is made of acrylic such as PET that forms a foldable rectangular plate shape. It is a substrate. The chip body side substrate 111 and the opening / closing body side substrate 112 have the same contour shape in plan view.

  The chip body side substrate 111 forms the chip body 2 and is a hydrophilic substrate by applying a hydrophilic coating to the substrate surface. As the hydrophilic coating, it is conceivable to coat polysaccharides such as heparin, nucleotides such as DNA, or compounds such as surfactants. In addition, what added hydrophilicity by plasma processing may be used.

  As shown in FIGS. 2 to 5, the chip body side substrate 111 has the introduction path 2 </ b> B together with the lower surface of the cover substrate 12 by bonding or bonding the cover substrate 12 to the upper surface thereof. A concave groove 111a to be formed and a storage groove 111b to form the test liquid storage part 2F are provided.

  As shown in FIG. 2 and the like, the concave groove 111a has one end opened on the side surface 111r of the chip body side substrate 111 and is formed linearly along the longitudinal direction of the chip body side substrate 111. Specifically, the concave groove 111a is a groove having a shape in which blood is transferred by capillary action after the cover substrate 12 is bonded or bonded.

  The storage groove 111b is for expanding a groove width on the downstream side of the concave groove 111a to store a predetermined amount of test liquid (blood), and has the same depth as the concave groove 111a (FIG. 5). reference).

  In such a configuration, the introduction path 2 </ b> B and the test liquid storage unit 2 </ b> F are formed by bonding or bonding the cover substrate 12.

  In particular, as shown in FIG. 5, a through hole 111 c that forms the opening 2 </ b> D is formed at the bottom of the storage groove 111 b of the chip body side substrate 111.

  The inner diameter of the through hole 111c is smaller than the diameter of the tip of the enzyme electrode sensor Z3. In other words, the opening 2D is smaller than the diameter of the tip of the enzyme electrode sensor Z3. Thereby, at the time of measurement, the front-end | tip part of enzyme electrode sensor Z3 contacts the separation membrane 2E while contacting the opening edge part of the exterior side of opening part 2D.

  An annular step 111d for accommodating and fixing the separation membrane 2E is formed at the opening edge of the through hole 111c on the storage groove 111b side (see FIG. 5). The depth of the annular step 111d is substantially the same as the thickness of the separation membrane 2E. Thereby, when the separation membrane 2E is accommodated in the annular step portion 111d, the bottom surface of the storage groove 111b and the top surface of the separation membrane 2E are flush with each other (see FIG. 5). Thereby, the blood can easily flow through the introduction path 2B (the test liquid storage part 2F) without the separation membrane 2E interfering with the capillary phenomenon in the introduction path 2B (the test liquid storage part 2F).

  The separation membrane 2E 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, as the separation membrane 2E, a polycarbonate membrane or the like may be used.

  The opening / closing body side substrate 112 forms the opening / closing body 3 as shown in FIGS. 2, 3, and 5, and has a rectangular plate shape like the chip body side substrate 111. The opening / closing body side substrate 112 is rotatably connected to one side of the side surface 111r where the concave groove 111a is opened in the chip body side substrate 111. Specifically, the side surface 111r where the groove 111a is open is connected to a side 111e (the lower side in FIG. 2 and the like) opposite to the groove 111a.

  As a connection method, a single substrate may be cut into a chip body side substrate 111 and an opening / closing body side substrate 112, and the opening / closing body side substrate 112 may be rotatable with respect to the chip body side substrate 111. Alternatively, the chip body side substrate 111 and the opening / closing body side substrate 112 may be prepared and connected by a link mechanism, or the opening / closing body side substrate 112 may be connected to the chip body side substrate 111 by an adhesive tape or the like. .

  Furthermore, the thickness of the opening / closing body side substrate 112 is a thickness obtained by combining the thickness of the chip body side substrate 111 and the thickness of the cover substrate 12 described later. The length of one side to which the open / close body side substrate 112 is connected is the same as the length of one side to which the chip body side substrate 111 is connected. That is, the size of the connection side surface 112r of the opening / closing body side substrate 112 is the same as the size of the side surface 201 of the chip body 2 in which the contact hole 2A is formed (see FIGS. 3 and 5). Here, the size is a contour shape in a side view. Thereby, the entire side surface 201 having the contact hole 2A formed by the chip body side substrate 111 and the cover substrate 12 described later can be covered.

  The side surface 201 includes a connection side surface 111r in which the groove 111a of the chip body side substrate 111 is opened, and a connection side surface 12r that forms the contact port 2A together with the opening of the groove 111a in the cover substrate 12 described later. Consists of.

  As shown in FIGS. 2, 3, and 5, the cover substrate 12 is a substrate made of a resin such as PET or acrylic having a rectangular plate shape, like the chip body side substrate 111, and penetrates through the air holes 2C. A hole 121 is provided. Similar to the chip body side substrate 111, the surface on which the introduction path 2B and the like are formed is provided with a hydrophilic coating.

  In the state where the cover substrate 12 is attached to the main body substrate 11 (specifically, the chip main body side substrate 111), the through hole 121 communicates with the terminal portion of the concave groove 111a (see FIG. 5). Then, the introduction path 2B is formed by the lower surface of the cover substrate 12 and the concave groove 111a, and the test liquid storage portion 2F is formed by the lower surface and the storage groove 111b.

  <Production method>

  Next, a manufacturing method of the test solution analysis chip 1 according to the present embodiment will be described with reference to FIG.

  First, the concave groove 111a, the storage groove 111b, and the through hole 111c are formed on the upper surface of the rectangular plate-shaped chip body side substrate 111 by cutting or die processing. Further, a through hole 121 that is an air hole 2 </ b> C is formed in the cover substrate 12. Next, the separation membrane 2E is attached to the annular step portion 111d provided at the opening edge of the through hole 111c. The connection between the chip body side substrate 111 and the opening / closing body side substrate 112 and the method thereof are as described above.

  Then, the main body substrate 11 (chip main body side substrate 111) and the cover substrate 12 are bonded or bonded. At this time, the through holes 121 of the cover substrate 12 are bonded or bonded so as to communicate with the end portions of the concave grooves 111a.

  In this way, the chip body 2 having the introduction path 2B inside, the test liquid storage section 2F provided on the introduction path 2B, and the separation membrane 2E provided in the test liquid storage section 2F, and the chip main body The test solution analysis chip 1 including the opening / closing body 3 that selectively closes or opens the two contact ports 2A or the opening 2D is manufactured.

  In addition, as a raw material, although inorganic materials, such as resin other than an acrylic or glass, can also be manufactured, since a surface state changes with materials, there exists a difference also in capillary force. Therefore, it is necessary to change the cross-sectional shape of the narrow flow path (the concave groove 111a and the storage groove 111b) according to each material.

  <Effect of this embodiment>

  According to the test liquid analysis chip 1 of the present embodiment configured as described above, the opening 2D is opened with the opening / closing body 3 folded with respect to the chip body 2 before and during blood collection. It closes and the contact of the separation membrane 2E and the outside can be blocked to prevent the separation membrane 2E from being damaged. On the other hand, at the time of insertion and measurement after blood collection, the contact 3A is closed while the opening / closing body 3 extends with respect to the chip body 2, and the test liquid adhered to the contact 2A and its vicinity is used. It is possible to prevent external contamination of the operator and the device Z.

  Furthermore, only by bringing blood into contact with the contact port 2A, a certain amount of blood can be automatically collected by capillary action, and non-blood cell components can be easily separated from the blood. This eliminates the need for the user to drop using a dropper, syringe, or the like, and the concentration measurement device Z is contaminated by excessive dripping onto the separation membrane 2E, the measurement error due to the contamination of the device Z, and the separation. Damage to the membrane 2E can be prevented.

  <Other modified embodiments>

  The present invention is not limited to the above embodiment. In the following description, the same reference numerals are given to members corresponding to the above-described embodiment.

  For example, in the above-described embodiment, the test solution analysis chip 1 has a two-layer structure including the cover substrate 12 of the main body substrate 11. However, as shown in FIG. A spacer substrate 13 may be provided to form a three-layer structure. In this case, the main body substrate 11 includes a through hole 11H and an annular step portion 11D that form the opening 2D. In addition, the spacer substrate 13 includes a slit portion 13S that forms the introduction path 2B and the test liquid storage portion 2F together with the upper surface of the main substrate 11 and the lower surface of the cover substrate 12. In this case, the side surface 201 in which the contact hole is formed includes the connection side surface 111r of the chip body side substrate with the opening / closing body side substrate 112, the opening side surface 13r of the slit portion 13S of the spacer substrate 13, and the cover substrate 12. The chip body side substrate 111 and the spacer substrate 13 together with the side surface 12r forming the contact hole 2A.

  Further, in the main body substrate, the separation membrane may be disposed on the bottom surface of the storage groove without providing the annular step at the opening edge of the through hole.

  Further, the separation membrane may be provided at the outer opening edge of the opening. Even in this case, the opening / closing body covers the separation membrane before and during collection of the test liquid, so that the separation membrane can be prevented from being damaged.

  Moreover, although the opening-closing body of the said embodiment covered and closed the opening part in the folded state, it may not be so. However, when placed on the floor or the like in the folded state, the opening / closing body serves as a wedge, and the opening (or separation membrane) can be prevented from coming into contact with the outside such as the floor.

  In addition, the introduction path of the embodiment may not have a test liquid storage part. In this case, the flow path width of the introduction path can be set according to the size of the opening, or the size of the opening can be set according to the flow path width of the introduction path.

  In addition, the test liquid analysis chip of the above embodiment has a blood cell separation membrane that allows only non-blood cell components to pass therethrough and separates non-blood cell components from blood. The component to be measured may be separated from the test solution. In this case, a separation membrane is selected in accordance with the test solution and the measurement target component.

  In addition, some or all of the above-described embodiments and modified embodiments may be combined as appropriate, and the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the spirit of the present invention. .

The figure which shows the test | inspection liquid analysis chip | tip and concentration measuring apparatus which concern on one Embodiment of this invention. The perspective view (folded state) of the chip | tip for test liquid analysis of the same embodiment. FIG. 3 is a perspective view (extended state) of the test liquid analysis chip of the embodiment. FIG. 3 is a plan view of the test liquid analysis chip of the embodiment. AA sectional view taken on the line. The disassembled perspective view of the test liquid analysis chip of the embodiment. The disassembled perspective view of the test liquid analysis chip concerning other modification embodiments.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Test solution analysis chip | tip Z3 ... Electrode sensor 2 ... Chip body 2A ... Contact port 2B ... Introduction path 2D ... Opening part 2E ... Separation membrane 3 ... Opening / closing body 201... Side surface on which contact hole is formed

Claims (4)

A test liquid analysis chip for analyzing a test liquid,
A chip main body having a contact port with which the test solution comes into contact, and an introduction path that communicates with the contact port and introduces the test solution into the inside by capillary action;
Rotatably provided on the tip body, the contact hole and opening are in a state of being folded with respect to the chip body when taken before or collection of test solution, with respect to the chip body after collection of the sample liquid test liquid analysis chip comprising a closing body, the occluding covers the contact hole is in a state extending Te.   The test liquid analysis chip according to claim 1, wherein the opening / closing body is rotatably provided on a part of a side surface on which the contact port is formed.   The test liquid analysis chip according to claim 1 or 2, wherein the openable body covers the entire side surface where the contact hole is formed in a state where the openable body extends with respect to the chip body. An opening that is provided in a part of the introduction path, communicates the introduction path with the outside, and contacts an electrode sensor for analyzing a substance to be measured in the test liquid;
A separation membrane that is provided in the opening and separates the measurement target substance from the test solution and passes through the opening; and
The test liquid analyzing chip according to claim 3, wherein the opening / closing body covers and closes the opening in a state of being folded with respect to the chip body.