JP2008259779A - Manufacturing method of biosensor cartridge - Google Patents

Abstract

A biosensor cartridge manufacturing method suitable for mass production and capable of easily fixing a chip body of a biosensor chip to a resin magazine without using an adhesive or the like, thereby reducing man-hours and manufacturing costs. I will provide a.
A biosensor cartridge having a biosensor chip 7 having a sampling port on a tip surface and a resin magazine 1 that supports the biosensor chip 7 and is provided with a puncture device 5 at a tip portion. The biosensor chip 7 and the resin magazine 1 are both formed in the form of a connecting chip 8 and a connecting magazine 2 that are connected in the lateral direction, and the connecting chip 8 is fixed on the connecting magazine 2 in the vertical direction. It was cut and divided into a plurality of biosensor cartridges.
[Selection] Figure 4

Description

  The present invention relates to a method for manufacturing a biosensor cartridge that measures and analyzes blood or chemical substances using, for example, a reagent housed in a hollow reaction part of a biosensor chip.

Conventionally, for example, a biosensor in which a biosensor chip that detects the concentration of glucose in blood and a lancet are integrated is known (for example, Patent Document 1).
FIG. 7A is a perspective view of the sensor described in Patent Document 1, and FIG. 7B is an exploded perspective view of the sensor. As shown in FIG. 7, the lancet-integrated sensor 100 includes a chip body 101, a lancet 103, and a protective cover 105. The chip body 101 has a cover 101a and a substrate 101b that can be opened and closed, and an internal space 102 is formed on the inner surface of the cover 101a. The internal space 102 has a shape that can accommodate the lancet 103 in a movable manner.

  The needle 104 provided at the tip of the lancet 103 can be moved in and out from an opening 102 a formed at the front end of the internal space 102 of the chip body 101 as the lancet 103 moves. The lancet 103 can be fixed to the chip body 101 by pressing both sides of the chip body 101 with a finger and pressing the convex portion 103a of the lancet 103, and puncture is performed in this fixed state. The protective cover 105 has a tube part 105 a into which the needle 104 is inserted, and the tube part 105 a can be accommodated inside the chip body 101 as the needle 104 moves. Therefore, in a state before use, the protective cover 105 is put on the needle 104 to protect the needle 104 and prevent the user from being accidentally injured. Note that the substrate 101b is provided with a pair of electrode terminals 106 so that it can be electrically connected to a measuring apparatus (not shown).

  Therefore, in use, the protective cover 105 is removed, the lancet 103 is pushed, the needle 104 is protruded from the chip body 101, and both sides of the chip body 101 are pressed with fingers to fix the needle 104. After puncturing the subject in this state, the needle 104 is housed inside the chip body 101, and the opening 102a provided at the front end of the chip body 101 is brought close to the puncture port to collect the outflowed blood.

In addition, as another conventional technique, a single planar substrate is three-dimensionally processed so that an electrode placed in a space between the substrate and the cover is disposed inside the substrate, thereby reducing the size. A method for manufacturing a sensor is also disclosed (Patent Document 2). According to this, the plate member is bent so that the electrode formed on the surface of the electrically insulating plate member is inside, and the electrode is disposed in a space sandwiched between the substrate and the cover, Forming the substrate and the cover from the plate member.
International Publication No. 02/056769 Pamphlet Japanese Patent Laid-Open No. 2005-233917

  Each conventional biosensor employs a method in which a chip body or a protective case or cover for the chip body is formed in advance into individual pieces, and the separated parts are assembled one by one to complete a biosensor. Therefore, the process becomes complicated, the cost increases due to an increase in man-hours, and there is a problem in terms of productivity.

  The present invention has been made in view of the above problems, and it is an object of the present invention to provide a method for manufacturing a biosensor cartridge capable of efficiently performing mass production.

  The present invention also provides a biosensor cartridge manufacturing method that can easily fix the chip body of a biosensor chip to a protective case, that is, a resin magazine without using an adhesive or the like, thereby reducing man-hours and manufacturing costs. Is to provide.

  A biosensor cartridge manufacturing method according to the first aspect of the present invention includes a biosensor chip and a resin magazine that supports the biosensor chip and is provided with a puncture device. The biosensor chip and the resin magazine are both formed in the form of a plurality of connected chips and connected magazines that are connected in the lateral direction, and the connected chips are fixed on the connected magazine and cut longitudinally. And a step of dividing into a plurality of biosensor cartridges.

  In the method of manufacturing a biosensor cartridge configured as described above, a resin magazine having a biosensor chip and a puncture device for supporting the biosensor chip are not separated and then assembled together. On top of that, a plurality of biosensor chips are similarly assembled in advance, and then the connected parts are cut and separated into individual pieces, so that the complicated assembly process in the conventional state is not required. This is advantageous for mass production.

  A biosensor cartridge manufacturing method according to a second feature of the present invention is the method according to the first feature of the present invention, wherein a hollow elastic body surrounding the puncture instrument is fixed to the tip of the resin magazine. The connecting magazine is formed in a form in which a plurality of the resin magazines in a state where the elastic body is fixed are connected in the lateral direction.

  In the biosensor cartridge manufacturing method configured as described above, since the puncture device protruding from the connection magazine is accommodated in the elastic body, the puncture device can be used for puncture even when the connection tip is fixed on the connection magazine. There is no danger of hurting the instrument or touching the puncture instrument with your hand, and you can work safely.

  According to a third aspect of the present invention, there is provided the biosensor cartridge manufacturing method according to the first aspect of the present invention, wherein the elastic body has a plurality of lateral directions at the same pitch as the resin magazines constituting the articulated magazine. The connecting elastic body is fixed to the front end of the connecting magazine, and the connecting tips are fixed on the connecting magazine, and then cut in a longitudinal direction to form a plurality of connecting elastic bodies. Divide into biosensor cartridges.

  In the biosensor cartridge manufacturing method configured as described above, the connection magazine, the connection elastic body, and the connection chip are fixed together in advance, and then cut and separated into a plurality at the connection portion. Since a plurality of biosensor cartridges are obtained, the assembly process is simplified and mass production can be performed at a low cost compared to the case where the elastic bodies formed into individual pieces are fixed to the connecting magazine one by one.

  According to a fourth aspect of the present invention, there is provided a method for manufacturing a biosensor cartridge according to the first aspect of the present invention, wherein the rear end of each of the biosensor chips is separated into two parts to form an electrode pair. In this state, a plurality of side chips are connected in the lateral direction to form the connected chip, and the connected parts of the connected chips are cut in the vertical direction and divided into a plurality of biosensor chips.

  In the biosensor cartridge manufacturing method configured in this way, the biosensor device insertion electrode pair at the end of the chip is separated into two forks at the stage of connecting chip formation in advance so that the counter electrode and the working electrode are formed. By cutting in the length direction at the intermediate position of this electrode part, it is possible to easily obtain a biosensor chip with an electrode pair, which makes it extremely easy to form an electrode pair, and to form an electrode pair as in the past. There is no need for drilling, and there is no waste such as chips.

  According to a fifth aspect of the present invention, there is provided the biosensor cartridge manufacturing method according to the fourth aspect of the present invention, wherein the articulated magazine corresponds to the concave portion of the rear end bifurcated portion of each of the biosensor chips. A plurality of locking claws are formed at the rear end portion, and the concave portion at the rear end portion of the connecting chip is engaged with the locking claws, and the flange-like protruding portion at the front end of the connecting magazine and the locking The connecting tips are sandwiched in the length direction by the claws, and the connecting tips are fixed to the connecting magazine.

  In the biosensor cartridge manufacturing method configured as described above, the resin magazine locking claw that engages with the recess between the electrodes at the rear end of the biosensor chip and the flange-like protruding portion at the front end of the resin magazine The biosensor chip can be clamped and fixed, and the conventional adhesive for fixing the biosensor chip is not required, making it possible to further reduce the manufacturing cost and extremely efficient mass production. Make it possible.

  A biosensor cartridge manufacturing method according to a sixth feature of the present invention is the method according to any one of the first to fifth features of the present invention, wherein the resin magazine is formed with a lid that covers the biosensor chip, The lid is folded with respect to the resin magazine to close the biosensor chip.

  In the biosensor cartridge manufacturing method configured as described above, a lid that covers the biosensor chip on the resin magazine is formed integrally with the resin magazine, and the lid is bent with respect to the magazine body at the time of assembly. It is possible to cover the sensor chip, which makes it easier to assemble and manufacture the biosensor cartridge. Of course, the lid is not necessarily formed integrally with the resin magazine, but may be formed separately.

  As described above, according to the present invention, the biosensor chip and the resin magazine with a puncture device are not assembled after being separated into pieces, but are assembled together in a single state in advance and then cut into pieces. Therefore, assembly time and assembly labor can be reduced, and efficient mass production becomes possible.

  In addition, the biosensor chip has a bifurcated structure at the rear end of the biosensor chip, and this portion is used as an electrode pair, and a latching claw is formed on the rear of the resin magazine to engage with the bifurcated recess. Since the biosensor chip is fixed by engagement with the claws, it can be assembled without using any adhesive or the like as in the prior art, and this point is also suitable for mass production.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
It should be understood that the embodiments disclosed below are illustrative in all respects and are not restrictive. The scope of the present invention is defined by the terms of the claims, rather than the meanings described above, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.
FIG. 1 is a front view of a connection magazine 2 formed by connecting a plurality of resin magazines 1 of a biosensor cartridge according to an embodiment of the present invention, and FIG. 2 is a perspective view of the connection magazine 2 shown in FIG. The articulated magazine 2 has a shape suitable for mounting and supporting a biosensor chip, which will be described later, on its upper surface, and a flange-shaped protruding portion 3 is formed at the tip. In the illustrated embodiment, a front projection 22 having a smaller diameter than the outer diameter of the protruding portion 3 is formed at the center of the tip of the flange-shaped protruding portion 3. A small-diameter through-hole 4 for taking in liquid that has flowed out from the subject, for example, blood, is formed in the approximate center of the front projection 22 and the overhanging portion 3, and the puncture device 5 is placed near the through-hole 4 in the front projection. 22 is provided so as to protrude from 22.

  Examples of the puncture device 5 include a hollow needle such as a syringe needle and a solid needle such as a lancet needle. As will be described later, the liquid that has flowed from the through hole 4 is guided to a hollow reaction portion formed near the tip of the biosensor chip on the resin magazine 1. A reagent is introduced into this hollow reaction part.

  As clearly shown in FIG. 1, each resin magazine 1 is formed so that a plurality of resin magazines 1 are connected to each other at the side of the protruding portion 3 at the tip and the biosensor chip mounting portion. At the center position of the rear end portion of each resin magazine 1, a tapered locking claw 6 having a slope 6a is formed.

  As will be clearly shown in FIG. 6 to be described later, the biosensor cartridge of the present embodiment has substantially the same outer diameter as the overhanging portion 3 so as to surround the puncture device 5 and the front protrusion 22 protruding from the front protrusion 22. In this case, a plurality of elastic bodies 15 are formed so as to be connected to the side portions in advance.

  FIG. 3 is a perspective view of a connecting chip 8 formed by connecting a plurality of biosensor chips 7 united with the resin magazine 1 described above. Each biosensor chip 7 has a hollow reaction portion 9 formed near the front end portion, and a rear end portion is bifurcated, and electrodes 10 and 11 are formed on the upper surface thereof. These electrodes 10 and 11 extend along the upper surface of the biosensor chip 7 to the hollow reaction part 9 near the tip. A rectangular recess 12 is formed between the branched electrodes 10 and 11 at the rear end. Each biosensor chip 7 is connected to each other at its side portion to constitute a connecting chip 8 according to the present invention.

  5 (A) and 5 (B) are a partial front view and a plan sectional view of a connecting elastic body 21 formed in a state where a plurality of elastic bodies 15 are connected to each other at the side portions. The elastic bodies 15 constituting the articulated elastic body 21 are connected to each other at the same pitch p as the arrangement pitch p of the resin magazines of the articulated magazine, and the number thereof is the same as the number of resin magazines of the articulated magazine. ing. Each elastic body 15 has an elastic concave portion 15b that engages with the front protrusion 22 at the tip of the overhang portion 3 at the rear end portion of the overhanging portion 3, and the penetrating instrument 5 is received in the center of the concave portion 15b. A hole 16 is formed. The elastic body 15 will be further described later with reference to FIG.

  FIG. 4 is a perspective view of a state in which the connecting chip 8 is placed and fixed on the connecting magazine 2 to which the connecting elastic body 21 is fixed. As shown in the figure, the connecting elastic body 21 is fixed to the front end surface of the connecting magazine by aligning the center of each resin magazine with the center of each elastic body 15. The connected magazine 2 shown in FIGS. 1 and 2 is shown in a state before the connected elastic body 21 is fixed. The number of the connected resin magazines 1 and the number of the connected biosensor chips 7 are the same number (both connected in the illustrated example), and the tip of each biosensor chip 7 is the tip of the corresponding resin magazine 1. The connecting chip 8 is placed on the upper surface of the connecting magazine 2 so as to come into contact with the back surface of the flange-like overhanging portion 3. At this time, the latching claw 6 at the rear end of the connecting magazine 2 engages with the concave portion 12 of the bifurcated branching portion at the rear end of the connecting chip 8, whereby the entire connecting chip is locked with the overhanging portion 3 of the connecting magazine 2. It is fixed on the articulated magazine 2 by being sandwiched by the claws 6.

  The recess 12 and the engaging claw 6 are engaged with each other because the engaging claw 6 has a tapered tapered slope 6a, so that the tip of the connecting chip 8 is applied to the back surface of the overhanging portion of the connecting magazine 2. By pressing the rear end of the chip against the upper surface 2a (FIG. 2) of the connecting magazine 2 in a state, the bottom of the recess 12 slides on the slope of the locking claw 6 so that the locking claw 6 enters the recess 12 and is easily connected. The chip 8 is fixed.

  After the assembly of the connecting chip 8 and the connecting magazine 2 and the connecting elastic body 21 is completed in this way, the connecting portion of the biosensor chip 7 is cut together with the resin magazine 1 and the connecting elastic body 21 to separate them. An obtained biosensor cartridge is obtained. 3 and 4, the cutting position is indicated by a cutting line 13.

  In the illustrated example, the upper part of the biosensor chip is open. However, in some cases, the upper surface of the biosensor chip may be separately suppressed with a lid. It is desirable to manufacture the lid body integrally with the resin magazine and bend the base portion of the lid body at the time of assembly to cover the upper surface of the biosensor chip. Of course, such a lid is not necessarily formed integrally with the magazine, and may be a lid formed separately.

With reference to FIG. 6, the material and the machine of the elastic body attached to the front surface of the overhang portion at the tip of the resin magazine will be described.

  In this embodiment, the elastic body 15 has a cylindrical shape in which a through-hole 16 for forming a closed space around the puncture device 5 is formed by being pressed against a subject (not shown). The thickness of the elastic body 15 in the length direction is sufficient to reliably cover the tip of the puncture device 5. The through hole 16 of the elastic body 15 communicates with the resin magazine 1 and a sample collection port 17 formed at the tip of the biosensor chip 7.

  The elastic body 15 may be any material that can be elastically deformed in the length direction by being pressed against the subject. Preferably, the elastic body 15 is a rubber material such as silicone, urethane, or acrylic rubber, or a polymer alone or copolymerized such as ethylene or styrene. Rubber or sponge made of polymer, polyolefin such as polyethylene and polypropylene, polyester such as polyethylene terephthalate and polybutylene terephthalate, fluorine resin such as PFA which is a copolymer of polytetrafluoroethylene and perfluoroalkoxylene and polyfluoroethylene, etc. Available.

  It is desirable that the distal end surface 15a, which is a surface in contact with the subject of the elastic body 15, is made of a material such as adhesive silicone rubber or acrylic rubber, or the elastic body 15 is coated with an adhesive. As a result, the adhesion between the elastic body 15 and the subject can be improved, the displacement from the puncture position can be prevented, and the closed space can be reliably formed. Further, it is desirable that the inner peripheral surface of the through hole 16 is made of a hydrophilic material, or at least the inner peripheral surface is subjected to a hydrophilic treatment. Thereby, the collected blood can be easily passed, and even a small amount of blood can be reliably collected and guided to the hollow reaction part 9. The elastic body 15 is bonded to the tip of the overhang portion 3 of the resin magazine 1 with an appropriate adhesive.

  The hollow reaction portion 9 formed near the tip of the biosensor chip 7 is a space formed by the upper surface of the biosensor chip 7 and the pair of electrode plates 18 and 19. Accordingly, the front end portions of the pair of electrode plates are formed in an L shape so as to face each other and define the hollow reaction portion 9. For example, a reagent 20 that immobilizes an enzyme and a mediator and reacts with glucose in the blood to generate an electric current is administered to the hollow reaction unit 9 adjacent to the electrode plates 18 and 19. For example, a sample such as blood collected from the collection port 17 becomes a part that undergoes a biochemical reaction with the reagent.

  Examples of the reagent include enzymes such as glucose oxidase (GOD), glucose dehydrogenase (GDH), cholesterol oxidase, uricase, and electron acceptors. For example, in the case of a glucose biosensor chip that measures the amount of glucose in blood, this portion includes a glucose oxidase layer, a glucose oxidase-electron acceptor (mediator) mixture layer, a glucose oxidase-albumin mixture layer, or a glucose oxidase-electron. A receptor-albumin mixture layer or the like is formed. These layers may be formed using enzymes other than glucose oxidase, such as glucose dehydrogenase. Moreover, you may include a buffering agent, hydrophilic polymer, etc. in a chemical | medical agent as an additive.

  In the biosensor cartridge according to the present invention thus obtained, the electrode portion at the rear end of the biosensor cartridge is inserted into the terminal insertion portion of a biosensor device (not shown) that performs measurement and analysis of a sample during use. Electrical connection is made. The biosensor device is provided with a power source, a control device, a display unit (all not shown) and the like in addition to the terminal insertion unit described above.

  As described above, the method of manufacturing the biosensor cartridge according to the present invention does not assemble and manufacture the separated biosensor chip and the elastic body that surrounds the resin magazine and the puncture device on the tip surface, A series of connected biosensor chips, a connected resin magazine, and a connected elastic body are assembled in advance and cut into individual biosensor cartridges in this state, making the manufacturing process extremely simple and easy. Thus, the manufacturing method is suitable for mass production. In addition, since the part corresponding to the electrode of the connected biosensor chip is branched and formed in advance, mechanical processing such as punching and punching for forming an electrode pair becomes unnecessary, and the man-hour is reduced. In addition, the generation of chips and dust during machining can be avoided, and a highly reliable biosensor cartridge can be obtained.

It is a front view of the connection magazine which connected and shape | molded several resin magazines of the biosensor cartridge which concerns on embodiment of this invention. It is a perspective view of the connection magazine shown in FIG. FIG. 3 is a perspective view of a connecting chip formed by connecting a plurality of biosensor chips united with a resin magazine according to an embodiment of the present invention. It is a perspective view of the state where the connecting chip was placed and fixed on the connecting magazine according to the embodiment of the present invention. It is the partial front view (A) and plane sectional view (B) of the articulation elastic body which connected the elastic body concerning the embodiment of the present invention by the side. It is the top view which carried out the partial cross section of the biosensor cartridge which concerns on embodiment of this invention. It is a figure which shows the conventional biosensor, Comprising: (A) is a perspective view of the biosensor in an assembly state, (B) is an exploded perspective view of a biosensor.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Resin magazine 2 Connection magazine 3 Overhang | projection substance 4 Through-hole 5 Puncture tool 6 Locking claw 7 Biosensor chip 8 Connection chip 9 Hollow reaction part 10,11 Electrode 12 Recess 15 Elastic body 15b Elastic body recessed part 16 Through-hole 20 Reagent 21 articulated elastic body 22 front projection

Claims (6)

A biosensor cartridge comprising: a biosensor chip; and a resin magazine that supports the biosensor chip and is provided with a puncture device,
The biosensor chip and the resin magazine are both formed in the form of a connection chip and a connection magazine that are connected in a plurality in the lateral direction, and a plurality of the connection chips are cut in the vertical direction while being fixed on the connection magazine. The biosensor cartridge is divided into the biosensor cartridges described above.   A hollow elastic body surrounding the puncture device is fixed to the tip of the resin magazine, and the connecting magazine is formed in a form in which a plurality of the resin magazines with the elastic body fixed are connected in a lateral direction. The method for producing a biosensor cartridge according to claim 1, wherein:   The elastic body is formed in the form of a connecting elastic body connected in a plurality of lateral directions at the same pitch as each resin magazine constituting the connecting magazine, and the connecting elastic body is fixed to the tip of the connecting magazine; 2. The method of manufacturing a biosensor cartridge according to claim 1, wherein the connecting chip is fixed on the connecting magazine and then cut in a vertical direction to be divided into a plurality of biosensor cartridges.   A rear end portion of each of the biosensor chips is separated into two to form an electrode pair, and in this state, a plurality of the side ends are connected to form the connecting chip, and a connecting portion of the connected chips is The biosensor cartridge manufacturing method according to claim 1, wherein the biosensor cartridge is cut in a vertical direction and divided into a plurality of biosensor chips.   A plurality of locking claws are formed at the rear end portion of the connecting magazine corresponding to the concave portion of the rear end bifurcated portion of each biosensor chip, and the concave portion at the rear end portion of the connecting chip is the locking claw. The biosensor cartridge manufacturing method according to claim 4, wherein the connecting chip is fixed to the connecting magazine by an overhanging portion at a front end of the connecting magazine and the locking claw.   The biosensor chip according to claim 1, wherein a lid body that covers the biosensor chip is formed in the resin magazine, and the biosensor chip is closed by bending the lid body with respect to the resin magazine. A method for manufacturing a sensor cartridge.

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