WO2008004623A1

WO2008004623A1 - Biosensor cartridge and method for manufacturing the same

Info

Publication number: WO2008004623A1
Application number: PCT/JP2007/063466
Authority: WO
Inventors: Shingo Kaimori; Takahiko Kitamura; Akira Harada; Toshifumi Hosoya; Tsuyoshi Fujimura; Isao Karube; Masao Gotoh; Hideaki Nakamura; Tomoko Ishikawa
Original assignee: Sumitomo Electric Industries, Ltd.; National Institute Of Advanced Industrial Science And Technology
Priority date: 2006-07-07
Filing date: 2007-07-05
Publication date: 2008-01-10
Also published as: JP2008012188A

Abstract

A biosensor cartridge which reduces burden on a user by reducing the collection quantity of a sample required for measurement, and allows a sample at the puncture mouth to be sampled and measured without requiring an operation for bringing the sampling mouth close to the puncture mouth. Since a puncture piece (14) is fixed to at least one of a spacer layer (13) and a substrate (12b), a hollow reactive portion (16) can be made small. Consequently, a sampling quantity is reduced and the burden on a user can be lessened. Furthermore, a puncture position can be brought close to a sampling mouth (16a) because at least a portion of the puncture piece (14) is fixed to be embedded in the substrate (12b) or the spacer layer (13). Consequently, a sample at the puncture mouth can be collected and measured without requiring an operation for bringing the sampling mouth (16a) close to the puncture mouth.

Description

Specification

Biosensor cartridge and method of manufacturing biosensor cartridge

[0001] The present invention relates to a biosensor cartridge that measures and analyzes a chemical substance, for example, using a reagent contained in a hollow reaction part of the biosensor cartridge.

Background art

Conventionally, for example, a biosensor in which a biosensor chip and a lancet are integrated has been disclosed (see, for example, Patent Document 1).

FIG. 9A is a perspective view of the sensor described in Patent Document 1, and FIG. 9B is an exploded perspective view of the sensor. As shown in FIG. 9, the lancet-integrated sensor 100 has 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 capable of movably storing the lancet 103, and the lancet 103 can be exchanged by opening the cover 101a.

[0003] The needle 104 provided at the tip of the lancet 103 can be projected and retracted from an opening 102a 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 projection 103a of the lancet 103, and puncture is performed in this fixed state. The protective cover 105 has a pipe part 105 a into which the needle 104 is inserted, and the pipe part 105 a can be stored inside the chip body 101 as the needle 104 moves. Therefore, before use, the protective cover 105 is put on the needle 104 to protect the needle 104 and prevent the user from being injured accidentally. 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).

[0004] Accordingly, 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 is Blood is collected by bringing the opening 102a provided at the front end of the main body 101 close to the puncture opening.

Patent Document 1: International Publication No. 02Z056769 Pamphlet

Disclosure of the invention

Problems to be solved by the invention

[0005] However, in the lancet-integrated sensor described in Patent Document 1, the outer side of the chip body is used.

In the biosensor chip in which the puncture device is attached to the (outer surface of the substrate), the size of the internal space can be reduced, but the puncture port of the puncture port through which the sample flows out by being punctured by the puncture device. Since the position and the position of the sample extraction port of the biosensor chip for collecting the sample are separated from each other, a sample collection error is likely to occur. In the lancet-integrated sensor 100, since the needle 104 is movably provided in the internal space 102 between the cover 101a and the substrate 101b, the width and height of the internal space 102 are made larger than the outer diameter of the needle 104. However, since the internal space 102 for accommodating the sample becomes large, the amount of sample collected becomes large and the burden of blood collection on the user increases.

[0006] An object of the present invention is to reduce the burden on the user by reducing the amount of sample collected for measurement, and to easily remove the puncture port without requiring an operation for bringing the sample collection port close to the puncture port. It is an object of the present invention to provide a biosensor cartridge that can collect and measure a sample.

Means for solving the problem

[0007] In order to achieve the above-mentioned object, a biosensor cartridge according to the present invention includes a chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates. And a puncture device that is fixed to the tip of the tip body and protrudes from the tip, wherein at least a part of the puncture device is at least part of the substrate or the spacer layer. One of them is fixed by burial.

[0008] In the nanosensor cartridge configured as described above, since at least a part of the puncture device is fixed by being embedded in at least one of the substrate or the spacer layer, a hollow reaction is performed. The part can be made small. This reduces the amount of sample collected and reduces the burden on the user. At this time, at least a part of the puncture device Is fixed so as to be embedded in at least one of the substrate and the spacer layer, so that the puncture position can be brought close to the sampling port. As a result, the sample at the puncture port can be easily collected and measured without requiring an operation for bringing the sample collection port close to the puncture port. It is desirable to embed more than half of the puncture device. As a result, the puncture device can be prevented from falling off the spacer layer. In the present invention, a needle, a lancet needle, force-yure and the like are collectively referred to as a puncture device. For example, a solid needle such as a hollow needle or a lancet needle can be used. In addition, the puncture device may be fixed with a material such as grease for ease of handling and embedment in the substrate or the spacer layer.

In the biosensor cartridge according to the present invention, at least a part of the puncture device is fixed by being embedded in one of the two substrates.

In the nanosensor cartridge configured as described above, since the puncture device is attached to the substrate instead of the spacer layer, the thickness of the spacer layer can be reduced. The hollow reaction part provided in the spacer layer can be made small. As a result, the amount of sample collected can be reduced and the burden on the user can be reduced. At this time, since at least a part of the puncture device is fixed so as to be embedded in the substrate, the puncture device can be brought closer to the spacer layer, and the puncture position can be brought closer to the sample collection port. As a result, the sample at the puncture port can be easily collected and measured without requiring an operation for bringing the sample collection port close to the puncture port. It is desirable to fix more than half of the puncture device by embedding. Thereby, the puncture device can prevent the substrate force from dropping off.

[0011] Further, the biosensor cartridge according to the present invention resides in that at least a partial force of the puncture device is fixed to a groove provided in the substrate.

[0012] In the nanosensor cartridge configured as described above, at least a part of the puncture instrument is easily attached by attaching at least a part of the puncture instrument to the V groove provided on the substrate. Can be embedded in the substrate, and the puncture position can be brought close to the sample collection port. The depth of the groove is desirably a depth at which half or more of the puncture device is embedded. Examples of the method for fixing the puncture device to the groove include fixing with an adhesive or an adhesive tape, and heating and pushing the substrate. [0013] In addition, a method of manufacturing a biosensor cartridge according to the present invention includes a chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, and the chip. A biosensor force cartridge having a puncture device fixed to the distal end portion of the main body and protruding from the distal end, wherein at least a part of the puncture device is embedded when the substrate is molded from a molten resin. It is to be fixed by.

[0014] According to the manufacturing method of the nanosensor cartridge configured as described above, at least a part of the puncture device is fixed by being embedded in the substrate when the substrate is molded by molten resin. Therefore, the puncture device can be embedded and fixed in the substrate easily and reliably. Also, since a plurality of aligned puncture devices can be embedded at the same time on the aligned substrates, manufacturing efficiency is good. As a result, the thickness of the spacer layer can be reduced, and the hollow reaction part provided in the spacer layer can be reduced, thereby reducing the amount of sample collected and reducing the burden on the user. be able to. In addition, since the puncture device can be brought close to the spacer layer and the puncture position can be brought close to the sample collection port, the sample of the puncture port can be easily removed without requiring the operation of bringing the sample collection port close to the puncture port. It can be collected. It is desirable to arrange so that more than half of the puncture device is embedded. Thereby, the puncture device can prevent the substrate force from falling off.

[0015] Further, the biosensor cartridge manufacturing method according to the present invention includes a chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, and the chip. A biosensor force cartridge having a puncture device fixed to the tip of the lip body and protruding from the tip, wherein at least a part of the puncture device is pushed into the heat-softened substrate. It is to be fixed by burial.

[0016] In the manufacturing method of the nanosensor cartridge configured as above, the substrate is heated and softened, and at least a part of the puncture device is pushed in and fixed by embedding, so that the substrate is manufactured. Later, at least a part of the puncture device can be easily embedded and fixed. As a result, the thickness of the spacer layer can be reduced, and the hollow reaction part provided in the spacer layer can be reduced, reducing the amount of sample collected and reducing the burden on the user. can do. Also, since the puncture device can be brought closer to the spacer layer and the puncture position can be brought closer to the sample collection port, an operation for bringing the sample collection port closer to the puncture port is necessary. The sample of the puncture opening can be easily collected without requiring it. As a method of heat softening the substrate and the spacer layer, a sample having low heat resistance as a reaction sample to be accommodated in the hollow reaction part is to heat and soften only the embedded portion rather than heat softening the entire substrate and spacer layer. It is preferable because it can be used. As a partial heating method, it is possible to partially soften the embedded portion with a laser or to narrow the range of the heat effect by resistance welding.

[0017] The biosensor cartridge manufacturing method according to the present invention includes a chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, and the chip. A biosensor force cartridge having a puncture device fixed to the distal end portion of the main body and protruding from the distal end, wherein a groove is formed in the substrate, and at least a part of the puncture device is fixed in the groove There is to do.

[0018] In the manufacturing method of the nanosensor cartridge configured as described above! Thus, since at least a part of the puncture device is fixed in the groove formed in the substrate, the puncture device can be easily embedded in the substrate. As a result, the thickness of the spacer layer can be reduced, and the hollow reaction part provided in the spacer layer can be reduced, reducing the amount of sample collected and reducing the burden on the user. can do. In addition, since the puncture device can be brought close to the spacer layer and the puncture position can be brought close to the sample collection port, the sample of the puncture port can be easily removed without requiring the operation of bringing the sample collection port close to the puncture port. It can be collected. It is desirable that the depth of the groove is such that more than half of the puncture device is embedded. Further, as a method of fixing the puncture device in the groove, it can be fixed by pressing the adhesive, the adhesive tape, or the substrate with heat.

[0019] In addition, a biosensor cartridge manufacturing method according to the present invention includes a chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, and the chip. A biosensor force cartridge having a puncture device that is fixed to the tip of the lip body and protrudes from the tip, wherein at least a part of the puncture device is fixed in the substrate by ultrasonic bonding. There is.

[0020] In the manufacturing method of the nanosensor cartridge configured as described above, since at least a part of the puncture instrument is embedded in the substrate by external force ultrasonic bonding of the substrate, After the plate is manufactured, the puncture device can be easily attached by reducing the influence of heating. As a result, the thickness of the spacer layer can be reduced, and the hollow reaction part provided in the spacer layer can be reduced, thereby reducing the amount of sample collected and reducing the burden on the user. be able to. In addition, since the puncture device can be brought close to the spacer layer and the puncture position can be brought close to the sample collection port, the sample of the puncture port can be easily collected without the need to move the sample collection port close to the puncture port. Will be able to. In addition, it is more effective to perform ultrasonic bonding without force.

[0021] Further, the biosensor device according to the present invention includes the biosensor cartridge described above, or a biosensor force cartridge manufactured by the method of manufacturing the biosensor cartridge described above, and detection of the nanosensor cartridge. And a measuring instrument that obtains information on the sample collected by connecting to the electrode for use.

In the nanosensor device configured as described above, a sample is collected by the biosensor cartridge described above, and information on the sample is transmitted to the measuring device via the detection electrode, so that it can be performed in a short time and easily. Since it can be measured, the burden on the subject can be reduced.

The invention's effect

[0023] According to the present invention, since the puncture device is attached to at least one of the substrate or the substrate and the spacer layer, the hollow reaction part can be made small. This reduces the amount of sample collected and reduces the burden on the user. At this time, since at least a part of the puncture device is embedded in the substrate, the puncture device can be brought close to the sample collection port. As a result, it is possible to obtain an effect that the sample of the puncture port can be easily collected and measured without requiring the operation of bringing the sample collection port close to the puncture port.

Brief Description of Drawings

FIG. 1 (A) is a plan view showing a first embodiment according to the biosensor cartridge of the present invention. (B) is a side view of the force in the B direction in Fig. 1 (A). (C) is an end view seen from the direction C in Fig. 1 (A).

FIG. 2 (A) is a plan view showing a second embodiment according to the biosensor cartridge of the present invention. is there. (B) is a side view of the force in the B direction in Fig. 2 (A). (C) is an end view seen from the direction C in Fig. 2 (A).

FIG. 3 (A) is a plan view showing a method of integrally providing a puncture device when a substrate is molded. (B) is a side view.

FIG. 4 is an explanatory view showing an example of a method for heat-softening a substrate by resistance welding and embedding and fixing a puncture device.

FIG. 5 is an explanatory view showing another example of a method of heating and softening a substrate by resistance welding to embed and fix a puncture device.

FIG. 6 is an explanatory diagram showing a method for embedding and fixing a puncture device in a groove provided in a substrate.

FIG. 7 is an explanatory view showing a method of embedding and fixing a puncture device in a substrate by ultrasonic bonding.

FIG. 8 is a configuration diagram of a biosensor device according to the present invention.

FIG. 9 (A) is a perspective view of a conventional biosensor. (B) is an exploded perspective view of a noise sensor.

Explanation of symbols

[0025] 10, 10B Biosensor cartridge

11 Chip body

11a Tip

12a, 12b board

13 Spacer layer

14a Tip

14 Puncture device

18 groove

30 Biosensor device

31 Measuring instrument

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, embodiments according to the present invention will be described in detail with reference to the drawings. Fig. 1 (A) is a plan view showing the first embodiment of the biosensor cartridge of the present invention, Fig. 1 (B) is a side view of the force in the B direction in Fig. 1 (A), and Fig. 1 (C) is a diagram. 1 (A) Middle C direction force End view, Fig. 2 (A) is a plan view showing a second embodiment of the biosensor cartridge of the present invention, and Fig. 2 (B) is Fig. 2 (A). Fig. 2 (C) is an end view of the middle B direction as viewed from the C direction in Fig. 2 (A).

[0027] As shown in Figs. 1 (A) to (C), the biosensor cartridge 10 according to the first embodiment of the present invention includes two substrates 12a and 12b facing each other and the two substrates. A chip body 11 having a spacer layer 13 sandwiched between 12a and 12b, and a puncture device 14 fixed to the tip 1 la of the chip body 11 and protruding from the tip 14a. Further, at least a part of the puncture device 14 is embedded in at least one of the two substrates 12a and 12b 12b (hereinafter, the case where the puncture device 14 is attached to the substrate 12b will be described). It is fixed by.

[0028] That is, the two substrates 12a and 12b have an overall rectangular shape, and can be made of, for example, polyethylene terephthalate (PET). On the surface of at least one of the two substrates 12a and 12b on the spacer layer 13 side, for example, detection electrodes 15a and 15b are provided by printing carbon on the substrate 12a. The front end portion (the lower end portion in FIG. 1A) is bent in an L shape in a direction opposite to each other, and maintains a predetermined interval. A rectangular hollow reaction part 16 is formed by the two substrates 12a, 12b and the spacer layer 13 from the tip 11a of the chip body 11 to the part where the two detection electrodes 15a, 15b are opposed to each other. It is. At the tip of the hollow reaction part 16, a sample collection port 16 a through which blood as a sample collected by puncturing a specimen with a puncture device 14 is introduced into the hollow reaction part 16 is provided.

[0029] Accordingly, the hollow reaction part 16 has a rectangular space with the spacer layer 13 formed on the upper and lower surfaces of the substrates 12a and 12b and the detection electrodes 15a and 15b and cut into a predetermined shape as side walls. Is formed. For this reason, the detection electrodes 15a and 15b are exposed in the hollow reaction part 16, and an enzyme (in the case of a glucose sensor chip, for example, directly above or in the vicinity of the detection electrodes 15a and 15b in the hollow reaction part 16). Glucose oxidase, glucose dehydrogenase, etc.) and mediators (potassium ferricyanide, Huekousen, benze) A reagent 17 is provided which reacts with glucose in the blood collected by immobilizing quinone or the like and generating an electric current. Therefore, the hollow reaction part 16 is a part where a sample such as blood collected from the sample collection port 16a undergoes a biochemical reaction with the reagent 17.

Further, as shown in FIGS. 1 (A) and 1 (B), only the substrate 12a is extended at the rear end portion ib of the chip body 11, and the detection electrodes 15a and 15b are exposed.

[0030] In the biosensor cartridge 10 described above, the puncture device 14 is attached not to the spacer layer 13 but to the substrates 12a and 12b, so that the thickness of the spacer layer 13 is reduced. The hollow reaction part 16 provided in the spacer layer 13 can be made small. As a result, the amount of sample B collected can be reduced and the burden on the user can be reduced. At this time, since at least a part of the puncture device 14 is embedded in the substrate 12b, the puncture device 14 is moved closer to the spacer layer 13 and the puncture position is moved closer to the sample collection port 16a. Can As a result, the sample B at the puncture port can be easily collected and measured without requiring the operation of bringing the sample collection port 16a close to the puncture port. It is desirable to fix the puncture device 14 so that more than half of the cross section of the puncture device 14 is embedded. As a result, the puncture device 14 can be reliably prevented from falling off the substrate 12b, and the distance between the puncture position by the puncture device 14 and the sample collection port 16a can be shortened. A collection mistake can be prevented.

In the biosensor cartridge according to the present invention, in addition to the embodiments described above, at least a part of the puncture device may be fixed by being embedded in at least one of the two substrates and the spacer layer.

Next, a biosensor cartridge 10B according to a second embodiment of the present invention will be described based on FIG. In addition, the same code | symbol is attached | subjected to the site | part which is common in the biosensor cartridge 10 which concerns on 1st Embodiment mentioned above, and the overlapping description is abbreviate | omitted.

As shown in FIGS. 2 (A) to (C), in the biosensor cartridge 10B according to the second embodiment of the present invention, at least a part of the puncture device 14 is fixed to the groove 18 provided in the substrate 12b. Has been. Various shapes of the groove 18 are conceivable. For example, a force that can be any of a V shape, a partial arc shape, a rectangular shape, and the like is preferable. The puncture device 14 can be fixed by using an adhesive or adhesive tape. Various manufacturing methods, which will be described later, can also be applied.

[0032] In this way, by fixing the puncture device 14 in the groove 18 formed on the outer surface of the substrate 12b, the puncture device 14 can be easily embedded in the substrate 12b at an accurate position. The puncture position can be brought close to the sample collection port 16a. It is desirable that the depth of the groove 18 is a depth at which half or more of the cross section of the puncture device 14 is embedded. As a result, the puncture device 14 can be prevented from falling off the substrate 12b.

[0033] Next, a method for producing a biosensor cartridge according to the present invention will be described.

FIGS. 3A and 3B show a method for manufacturing a first biosensor force cartridge according to a third embodiment of the present invention. In this biosensor cartridge manufacturing method, a chip body 11 having two substrates 12a and 12b facing each other and a spacer layer 13 sandwiched between the two substrates 12a and 12b, and the chip body 11 is a method of manufacturing a biosensor cartridge 10 having a puncture device 14 that is fixed to the tip portion 11a of the boss 11 and protrudes from the tip 14a. Is fixed by burial.

That is, when molding the substrate 12b made of resin with the resin, the puncture device 14 is attached to a predetermined position of the mold 19 for molding the substrate 12b, and the molten resin is poured into the mold. Then, the substrate 12b in which at least a part of the puncture device 14 is embedded and fixed is integrally molded.

As shown in FIG. 3 (A), a plurality of molds 19 are provided in parallel to mold a plurality of substrates 12b, and a plurality of puncture devices 14 are placed at predetermined positions on the mold 19. The state placed in is shown. As shown in FIG. 3 (B), the puncture device 14 is arranged so that at least a part thereof is buried in the substrate 12b. At this time, it is desirable to arrange the puncture device 14 so that more than half of the cross-section of the puncture device 14 is fixed by embedding with coagulation.

As described above, in this first biosensor cartridge manufacturing method, at least a part of the puncture instrument 14 is embedded in the substrate 12b when the substrate 12b is molded by molten grease. Since it is fixed, the puncture device 14 can be easily and securely embedded in the substrate 12b, and more than half of the cross-section of the puncture device 14 can be easily fixed by being embedded. . In addition, since a plurality of puncture devices 14 aligned with the aligned substrates 12b can be embedded and fixed at a time, manufacturing efficiency is high. Also, puncture device Manufacturing efficiency can be further improved by fixing the tool in advance with a resin made of the same material as that of the substrate and molding it into a shape to be joined to the groove 18 of the substrate 12b.

Next, a method for manufacturing the second biosensor cartridge according to the fourth embodiment of the present invention will be described.

In this biosensor cartridge manufacturing method, a chip body 11 having two substrates 12a, 12b facing each other and a spacer layer 13 sandwiched between the two substrates 12a, 12b, and this A biosensor cartridge 10 having a puncture device 14 that is fixed to a tip portion 11a of a chip body 11 and protrudes from a tip 14a, wherein at least a part of the puncture device 14 is placed on a heat-softened substrate 12b. It is pushed in, embedded and fixed.

That is, the manufactured resin substrate 12b is heated and softened, and at least a part of the puncture instrument 14 is pushed into the softened portion and fixed.

As a method of heating and melting the substrate 12b, resistance welding can be used as shown in FIG. That is, the positive electrode 21a and the negative electrode 21b of the resistance welding terminal 21, for example, energize the metal puncture device 14 to cause the puncture device 14 to generate heat, and heat * soften the resin substrate 12b. . At the same time, a pressing force is applied to the puncture device 14 to push it into the inside of the grease 12b. Alternatively, as shown in FIG. 5, a high-resistance metal foil 22 is interposed between the resistance welding terminal 21 and the puncture device 14 to heat the puncture device 14 more efficiently and heat the puncture device 14 with the heat. 12b can be softened.

[0039] As described above, in this second biosensor cartridge manufacturing method, the substrate 12b is heated and softened, and at least a part of the puncture instrument 14 is pushed in and embedded. The puncture device 14 can be easily embedded in the formed substrate 12b later. In addition, by using resistance welding to heat the puncture device 14 and melting the substrate 12b, it can be heated at a pinpoint and in a short time, preventing other parts from being adversely affected by heating. can do.

[0040] Next, a method for manufacturing the third biosensor cartridge according to the fifth embodiment of the present invention will be described.

In this biosensor cartridge manufacturing method, a chip body 1 having two substrates 12a, 12b facing each other and a spacer layer 13 sandwiched between the two substrates 12a, 12b. 1 and a puncture device 14 that is fixed to the tip end portion 11a of the chip body 11 and protrudes from the tip end 14a, in which a groove 18 is formed in the substrate 12b, and the groove 18 is punctured. It fixes at least a part of the appliance 14.

That is, as shown in FIG. 6, the groove 18 is formed in advance on the resin substrate 12b, or the groove 18 is formed after manufacturing, and the puncture device 14 is positioned in the groove 18. As a method of fixing the puncture device 14 to the groove 18, an adhesive or an adhesive tape can be used. Alternatively, at least a part of the puncture device 14 can be pushed into the groove 18 by simultaneously performing heat melting by using the resistance welding described above. Alternatively, the puncture device 14 may be fixed with a grease and previously molded so as to be joined to the groove 18 and pushed.

[0042] As described above, in the third method of manufacturing a biosensor cartridge, since at least a part of the puncture device 14 is fixed to the groove 18 formed in the substrate 12b, the puncture device 14 can be easily obtained. Can be embedded and fixed in the substrate 12b. In addition, the depth at which the puncture device 14 is embedded can be easily adjusted by the depth of the groove 18, and more than half of the cross-section of the puncture device 14 can be embedded and fixed. Furthermore, when heating and melting are performed simultaneously, embedding at least a part of the puncture device 14 can prevent the fat from rising around the periphery, and can improve the finish.

Next, a method for manufacturing the fourth biosensor cartridge according to the sixth embodiment of the present invention will be described.

In this biosensor cartridge manufacturing method, a chip body 11 having two substrates 12a, 12b facing each other and a spacer layer 13 sandwiched between the two substrates 12a, 12b, and this A biosensor cartridge 10 having a puncture device 14 fixed to the tip portion 11a of the chip body 11 and protruding from the tip 14a, wherein at least a part of the puncture device 14 is ultrasonically bonded to the inside of the substrate 12b. It is to be fixed to.

That is, as shown in FIG. 7, the puncture device 14 is placed on the resin substrate 12b, the puncture device 14 is pressurized by the pressurizing means 23, and the pressurizing means 23 is used as the horn 24. By oscillating in parallel (in the direction of the arrow in FIG. 7), Secure in the plate 12b. At this time, heating and melting can be performed simultaneously.

[0045] As described above, in the fourth method of manufacturing a biosensor cartridge, since the external force of the substrate 12b is also embedded in the substrate 12b by ultrasonic bonding, at least a part of the puncture instrument 14 is embedded in the substrate 12b. After the manufacture, the puncture device 14 can be easily embedded and fixed while reducing the influence of heating.

Next, a biosensor device according to a seventh embodiment of the invention will be described. FIG. 8 shows a configuration of a biosensor device 30 using the above-described biosensor cartridges 10 and 10B.

As shown in FIG. 8, the biosensor device 30 includes the biosensor cartridge 10, 1OB described above, or the biosensor cartridge 10, 10B manufactured by the biosensor cartridge manufacturing method described above, and the biosensor cartridge 10 And a measuring instrument 31 for obtaining information on blood collected by connecting to the detection electrodes 15a and 15b of 10B. The configuration of the biosensor cartridges 10 and 10B is as described above, and the same reference numerals are given to the same parts as the biosensor cartridges 10 and 10B described above, and the description thereof is omitted here.

The measuring device 31 includes a power source 32, a control device 33, a terminal insertion unit 34, and a display unit 35, which are connected to each other. The rear end l ib of the chip body 11 of the biosensor cartridge 10 is inserted and fixed to the terminal insertion part 34, and the detection electrodes 18a and 18b exposed at the rear end l ib of the chip body 11 are fixed. Are electrically connected. The biosensor device 30 is small in size, for example, a handy type that a subject can hold with one hand. Although not shown in the figure, the biosensor device 30 is provided with a puncture mechanism (lancet) in which the chip body can be moved by panel means or the like, and a cap 36 provided at the tip of the sensor device 30 is provided. Puncture can be performed by pressing the finger of the person to be inspected against the tip and moving the tip body 11. After the puncture is completed, blood can be collected with a biosensor, and blood glucose level and the like can be measured.

In the biosensor device 30 described above, blood is collected by the biosensor cartridges 10 and 10B described above, and blood information is transmitted to the measuring device 31 via the detection electrodes 15a and 15b. Because it can be measured in a short time and easily, The burden can be reduced.

Note that the biosensor cartridge of the present invention is not limited to the above-described embodiments, and can be appropriately modified and improved.

For example, in each of the embodiments described above, the case where the detection electrodes 15a and 15b are provided on one substrate 12a and the puncture device 14 is provided on the other substrate 12b is exemplified.

14 can be provided on the same substrate 12a as the detection electrodes 15a and 15b.

[0050] Although the invention has been described in detail and with reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention. is there.

This application is based on a Japanese patent application filed on July 7, 2006 (Japanese Patent Application No. 2006-188527), the contents of which are incorporated herein by reference.

Industrial applicability

[0051] As described above, in the biosensor cartridge according to the present invention, since the puncture device is attached to the substrate instead of the spacer layer, the thickness of the spacer layer can be reduced. The hollow reaction part provided in the spacer layer can be made small. As a result, the amount of sample collected can be reduced and the burden on the user can be reduced. At this time, since at least a part of the puncture device is fixed so as to be embedded in the substrate, the puncture device can be brought close to the spacer layer, and the puncture position can be made close to the sample collection port. This has the effect that the sample of the puncture port can be easily collected and measured without requiring the operation of bringing the sample collection port close to the puncture port, and the reagent contained in the hollow reaction part of the cartridge can be measured. It is useful as a biosensor cartridge for measuring and analyzing chemical substances.

Claims

The scope of the claims

[1] A chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, a puncture device fixed to the tip of the chip body and protruding from the tip A biosensor cartridge comprising:

A biosensor cartridge, wherein at least a part of the puncture device is fixed by being embedded in at least one of the substrate and the spacer layer.

[2] The biosensor cartridge according to claim 1, wherein at least a part of the puncture device is fixed by being embedded in one of the two substrates.

[3] The biosensor cartridge according to claim 1 or 2, wherein the puncture device is fixed in a groove provided in the substrate.

[4] A chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, a puncture device fixed to the tip of the chip body and protruding from the tip A biosensor cartridge manufacturing method comprising:

A method of manufacturing a biosensor cartridge, wherein at least a part of the puncture device is fixed by embedding when the substrate is molded from a molten resin.

[5] A chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, a puncture device fixed to the tip of the chip body and protruding from the tip A biosensor cartridge manufacturing method comprising:

A biosensor cartridge manufacturing method, wherein at least a part of the puncture device is pushed into the heat-softened substrate and fixed by embedding.

[6] A chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, a puncture device fixed to the tip of the chip body and protruding from the tip A biosensor cartridge manufacturing method comprising:

A method for producing a biosensor cartridge, comprising: forming a groove in the substrate; and fixing at least a part of the puncture device in the groove.

[7] A chip body having two substrates facing each other and a spacer layer sandwiched between the two substrates, and a puncture device fixed to the tip of the chip body and protruding from the tip A biosensor cartridge manufacturing method comprising: A biosensor cartridge manufacturing method, wherein at least a part of the puncture device is fixed in a substrate by ultrasonic bonding.

The biosensor cartridge according to any one of claims 1 to 3, or the biosensor cartridge manufactured by the method of manufacturing a biosensor cartridge according to any one of claims 4 to 7, and the noise sensor A biosensor device comprising: a measuring instrument connected to a detection electrode of a sensor cartridge to obtain information on a sample collected.