WO2008023703A1

WO2008023703A1 - Biosensor cartridge

Info

Publication number: WO2008023703A1
Application number: PCT/JP2007/066195
Authority: WO
Inventors: Tsuyoshi Fujimura; Isao Karube; Masao Gotoh; Hideaki Nakamura; Tomoko Ishikawa; Takahiko Kitamura; Akira Harada; Shingo Kaimori; Hiroto Nakajima; Hiroshi Hayami; Toshifumi Hosoya
Original assignee: Sumitomo Electric Industries, Ltd.; National Institute Of Advanced Industrial Science And Technology
Priority date: 2006-08-22
Filing date: 2007-08-21
Publication date: 2008-02-28

Abstract

To provide a biosensor cartridge in which burden on a user can be lessened by decreasing the quantity of a sample required for measurement, and the sample at the puncture mouth can be sampled easily without requiring an operation for making a sampling mouth approach the puncture mouth. When one end of a biosensor chip (11) is pressed against a specimen, an elastic body (20) is compressed to allows a puncture tool to project (12) and the specimen can be punctured. When the pressing force is weakened, the puncture tool (12) is drawn out from the specimen by the restoring force of the elastic body (20) and a sample flows out from the puncture mouth. Since the puncture mouth and a sampling mouth (13) provided in the biosensor chip (11) are included in an enclosed half-open space (23) formed by the elastic body (20), even a small quantity of sample can be sampled easily. Furthermore, since a protrusion (19) provided on one member is fitted in a recess (26) provided in the other member at the joint between the elastic body (20) and the biosensor chip (11), the elastic body (20) can be fixed surely to a predetermined position of the biosensor chip (11).

Description

Specification

Nokuo sensor cartridge

Technical field

The present invention relates to a biosensor cartridge, for example, a biosensor cartridge that measures and analyzes a chemical substance using a reagent accommodated in a hollow reaction part of a chip.

Background art

Conventionally, for example, biosensor chips that detect the concentration of glucose in blood are known (see, for example, Patent Document 1).

FIG. 15 is an exploded perspective view showing the glucose sensor described in Patent Document 1. FIG. As shown in FIG. 15, a glucose sensor 100 that is a biosensor has a counter electrode 101 and a working electrode 102. The counter electrode 101 has a hollow needle shape half cut in the length direction, and its tip end portion 103 is obliquely cut into an injection needle shape so that it can be easily punctured. The cut surfaces that have been cut are generally coated with insulating layers 104 and 104 'that also serve as adhesive layers, such as epoxy resin adhesives, silicone adhesives, or glass. The insulating layers 104 and 104' The working electrode 102 is attached via The working electrode 102 is a flat plate member on which glucose oxidase (GOD) is fixed, and is adhered to the counter electrode 101 with the surface on which the GOD is fixed facing inward.

Therefore, blood is collected by puncturing the subject 103 with the tip 103 of the needle-shaped counter electrode 101, and the reaction between the collected blood and the immobilized GOD 105 is detected by the working electrode 102, and glucose is quantified.

[0003] In addition, a biosensor in which a biosensor chip and a lancet are integrated is disclosed (for example, see Patent Document 2).

FIG. 16 (A) is a perspective view of the sensor described in Patent Document 2, and FIG. 16 (B) is an exploded perspective view of the sensor. As shown in FIG. 16, the lancet-integrated sensor 110 has a chip body 111, a lancet 113, and a protective cannula 115. The chip body 111 (cano 111a and substrate 111b can be opened and closed, and the inner space 112 is formed on the inner surface of the cover 111a. It is made. The internal space 112 has a shape that can accommodate the lancet 113 in a movable manner.

[0004] The needle 114 provided at the tip of the lancet 113 is formed at the front end of the internal space 112 of the tip body 111 as the lancet 113 moves! It has become. The shape of the internal space 11 la is curved so that the width thereof is slightly narrower than that of the lancet 113 at the end where the protrusion 113a is located, and the lancet 113 is attached to the chip body 111 by the mutual pressing force and frictional force. Being locked up! / The protective cover 115 has a tube portion 115 a into which the needle 114 is fitted, and the tube portion 115 a can be accommodated inside the chip body 111 as the needle 114 moves. Therefore, in a state before use, the protective cover 115 is put on the needle 114 to protect the needle 114 and to prevent accidental injury to the user. The substrate 11 lb is provided with a pair of electrode terminals 116 so that it can be electrically connected to a measuring device (not shown).

[0005] In use, remove the protective cover 115 and push the lancet 113 to place the needle 114 into the tip body.

11 Project from 1. After puncturing the subject in this state, the needle 114 is housed inside the chip body 111, and the opening 112a provided at the front end of the chip body 111 is brought close to the puncture port to collect the spilled blood. .

Patent Document 1: Japanese Patent Laid-Open No. 2-120655

Patent Document 2: Pamphlet of International Publication No. 02/056769

Disclosure of the invention

Problems to be solved by the invention

However, in the glucose sensor 100 described in Patent Document 1, since the needle-like counter electrode 101 and the working electrode 102 are bonded together, the diameter of the puncture needle is approximately the same as the width of the glucose sensor 100 and is large. Become. For this reason, there is a problem that the amount of blood collected increases and the pain at the time of puncture increases, which increases the burden on the user.

In addition, the lancet-integrated sensor 110 described in Patent Document 2 has a complicated force S and a structure that absorbs blood flowing out from the puncture port from the opening 112a. Furthermore, it is proposed to provide a cavity for storing blood separately from the internal space 112 of the chip body 111. In this case, the cavity size should be set independently of the lancet 113. Therefore, it can be considered that the amount of collected blood can be reduced. However, even though the piercing position by the lancet 113 and the cavity entrance are located at different positions, the blood discharged on the skin surface and the blood adhering to the needle 114 are effectively contained in the cavity. There is no disclosure of any mechanism for housing the container.

[0007] The present invention has been made in view of the above-described problems, and 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 puncture the sample collection port. It is an object of the present invention to provide a biosensor cartridge that can easily collect and measure a sample of a puncture mouth without requiring an operation to bring it close to the mouth.

Means for solving the problem

[0008] In order to achieve the above-mentioned object, the first feature of the biosensor cartridge according to the present invention is a biosensor chip and a puncture for puncture that is fixed to a part of the biosensor chip and has a protruding tip. A biosensor cartridge having a sampling instrument, including a sample sampling port provided at a tip of the biosensor chip and a puncture port formed in the subject by the puncturing instrument, and a space necessary for sampling The surface of the elastic body in contact with the biosensor chip and the surface of the biosensor chip in contact with the elastic body are fitted by an uneven structure. is there.

In the biosensor cartridge configured as described above, when one end of the biosensor chip is pressed against the subject, the elastic body provided in a part of the biosensor chip is compressed and the puncture device protrudes. Thus, the subject can be punctured. When the pressing force is weakened, the puncture instrument is pulled out from the subject by the restoring force of the elastic body, and the sample flows out from the puncture port. In addition, the connecting portion between the elastic body and the biosensor chip is fitted with a convex portion on one side and a concave portion on the other side, so that the elastic body can be securely attached to a predetermined position of the biosensor chip. it can. It should be noted that the puncture device and the user can be protected by preventing the puncture device from protruding from the distal end surface of the elastic body before use. Further, even when discarded after use, the puncture device can be safely and properly disposed of by preventing it from protruding from the tip surface of the elastic body. [0010] In addition, the second feature of the biosensor cartridge which is advantageous for the present invention is that in the first feature of the present invention described above, the sampling is provided at the tip of the biosensor chip by the sealed semi-open space. The mouth and the puncture port formed in the subject by the puncture device are connected to each other.

In the biosensor cartridge configured as described above, at the time of puncturing, the puncture port and the sample collection port provided at the tip of the biosensor chip are connected by a closed semi-open space formed by an elastic body. Therefore, it is easy to take a sample even with a small amount of sample.

[0012] In addition, a third feature of the biosensor cartridge according to the present invention is that, in the first or second feature of the present invention, the biosensor chip is provided with the convex portion and the elastic body has the above-described feature. A concave portion is provided, and the convex portion has a columnar shape, a prismatic shape, or a truncated cone shape.

In the biosensor cartridge configured as described above, the convex portion is provided in the biosensor chip, and the concave portion in which the convex portion is fitted is provided in the elastic body. The sensor chip and the elastic body can be easily manufactured. At this time, the shape of the convex portion formed on the nanosensor chip is changed to a cylindrical shape, a prismatic shape, or a truncated cone shape.

[0014] Further, the fourth feature of the biosensor cartridge according to the present invention is that in the first to third features of the present invention described above, the convex portion of the biosensor chip, the concave portion of the elastic body, Are fitted (fixed) by the elastic force of the elastic body.

[0015] In the biosensor cartridge configured as described above, the biosensor chip and the elastic body are fitted by the elastic force of the elastic body, so that the biosensor chip can be securely fixed and can be easily manufactured.

[0016] Further, a fifth feature of the biosensor cartridge according to the present invention is that, in the first feature of the present invention, a recess is provided on the side of the biosensor chip to which the elastic body is attached, An engaging tool having a convex part that fits into the concave part is integrally attached to the biosensor chip attaching side of the elastic body.

In the biosensor cartridge configured as described above, the biosensor chip is removed. Since the engagement tool having a convex part that fits into the concave part on the attachment side is attached to the elastic body, the attachment using the engagement tool ensures the attachment strength regardless of the type of constituent material of the elastic body. As well as being able to arrange the elastic body, troublesome softness, and made of material! /, But it does not affect the installation work, so productivity is good! /.

[0018] Further, the sixth feature of the biosensor cartridge according to the present invention is that, in the first feature of the present invention, a recess is provided on the side of the biosensor chip to which the elastic body is attached, An engaging tool having a convex part that fits into the concave part is configured separately from the elastic body !, and the engaging tool can be attached from the subject contact side of the elastic body. As described above, the elastic body is provided with a hole through which the convex portion passes.

[0019] In the biosensor cartridge configured as described above, since the engaging tool having the convex portion to be fitted into the concave portion on the biosensor chip mounting side is configured separately from the elastic body, the elastic body is used. When attaching to the biosensor chip, the convex part of the engaging tool is passed through the hole of the elastic body and integrated, and the convex part of the engaging tool can be attached and fixed simply by fitting into the concave part of the biosensor chip. Productivity is good.

[0020] The biosensor cartridge according to the seventh feature of the present invention is characterized by the first to sixth features of the present invention, or any one of the features! It has a drive mechanism for puncturing a specimen.

[0021] In the biosensor cartridge configured as described above, the puncture device can be punctured by the drive mechanism to puncture the subject, so that the puncture time can be shortened and pain when taking the sample can be reduced. It can be reduced.

[0022] Further, an eighth feature of the biosensor cartridge according to the present invention is that in any one of the first to seventh features of the present invention described above, at least a surface of the elastic body in contact with the subject is adhesive. It is to have sex.

[0023] In the biosensor cartridge configured as described above, since at least the surface of the elastic body that comes into contact with the subject has adhesiveness, the elastic body can be in close contact with the subject, and the shift of the puncture position can be prevented. In addition, a sealed semi-open space can be reliably formed. [0024] Further, a ninth feature of the biosensor cartridge according to the present invention is that, in any one of the first to eighth features of the present invention, the elastic body and the tip of the biosensor chip are provided. It is fixed with adhesive or double-sided tape.

In the biosensor cartridge configured as described above, the elastic body can be reliably attached to the tip of the biosensor chip. When using a pressure-sensitive adhesive, if there is a gap between the elastic body and the nanosensor chip, the adhesive can be applied so that the gap is crushed, so that a sealed semi-open space can be reliably formed. At the same time, leakage of collected samples can be prevented. When applying an adhesive to the contact surface between the convex part and the concave part, care must be taken so that it does not protrude into the part of the sample flow path or inside the nanosensor chip.

[0026] Further, a tenth feature of the biosensor cartridge according to the present invention is the biosensor cartridge according to any one of the first to ninth features of the present invention, wherein the elastic body is punctured by compressing the elastic body. The puncture device may be removed from the subject by the restoring force of the body, and the sample may be collected from the sample collection port.

In the biosensor cartridge configured as described above, when one end of the biosensor chip is pressed against the subject, the elastic body provided at the one end of the biosensor chip is compressed and the puncture device protrudes. Thus, the subject can be punctured. After that, the puncture device is removed by the restoring force of the elastic body, and the sample flowing out from the puncture port is collected from the sample collection port in the space formed by the elastic body. Therefore, after the puncture, the sample collection port is used as the puncture port. A sample can be reliably collected without positioning. This enables analysis with a small amount of sample, thereby reducing the burden on the subject.

[0028] Further, a biosensor device according to the present invention is collected by connecting to the biosensor cartridge according to any one of the first to tenth aspects of the present invention and a detection electrode of the biosensor cartridge. And a measuring instrument for obtaining information on the sample.

[0029] In the biosensor device configured as described above, since the sample is collected by the biosensor cartridge described above, the puncture and the sample collection can be performed in a series of operations, and the biosensor as in the conventional case. The sample can be collected easily and reliably without having to align the sample sampling port of the chip with the puncture port. The sample information is also detected. By transmitting to the measuring instrument via the pole, it is possible to perform measurement in a short time and easily, so that the burden on the subject can be reduced.

The invention's effect

[0030] According to the present invention, since the elastic body is provided at one end of the biosensor chip, after the puncture, the puncture device is pulled out by the restoring force of the elastic body, and the sample is removed from the sealed semi-open space formed by the elastic body. Therefore, even a small amount of sample can be easily collected through the sampling port. In addition, in the connecting portion between the elastic body and the biosensor chip, a convex portion is provided on one side and a concave portion is provided on the other side, and the elastic body can be securely attached to a predetermined position of the biosensor chip. The effect that it can be obtained. Brief Description of Drawings

FIG. 1 (A) is an explanatory view showing a first embodiment of a biosensor cartridge according to the present invention. (B) is an explanatory view showing an embodiment of a biosensor cartridge according to the present invention.

FIG. 2 is an exploded perspective view showing a joint portion between an elastic body and a biosensor chip.

FIG. 3 (A) is a cross-sectional view showing a joint portion between an elastic body and a biosensor chip. (B) is a cross-sectional view showing a joint between an elastic body and a biosensor chip.

FIG. 4 is a plan view showing an embodiment of a biosensor device according to the present invention.

[FIG. 5] (A) to (C) are explanatory views showing an operation of measuring a blood glucose level using the biosensor device according to the present invention.

FIG. 6 (A) is an explanatory view showing a second embodiment of the biosensor cartridge according to the present invention. (B) is an explanatory view showing a second embodiment of the biosensor cartridge according to the present invention.

FIG. 7 is a cross-sectional view showing a third embodiment of the biosensor cartridge according to the present invention.

FIG. 8A is a cross-sectional view of the biosensor chip of FIG. (B) is a bottom view seen from the needle tip direction.

9 is a perspective view showing the configuration of the integral type engaging tool and elastic body of FIG. 7. FIG.

FIG. 10 is a schematic view showing an example of a measuring apparatus equipped with the biosensor cartridge of FIG. 11] A cross-sectional view showing a fourth embodiment of the biosensor cartridge according to the present invention.

Yes

FIG. 12 (A) is a perspective view of the elastic body in FIG. 11 as viewed from above (sensor body side). (B) is a perspective view seen from below (needle tip side).

13] FIG. 13 is a perspective view showing the configuration of the engagement tool in FIG.

FIG. 6 is a cross-sectional view showing a fifth embodiment of the biosensor cartridge according to the present invention. 15] An exploded perspective view showing a conventional biosensor chip.

FIG. 16 (A) is a perspective view showing a conventional biosensor chip. (B) is an exploded perspective view showing a conventional biosensor chip.

Explanation of symbols

10 Biosensor cartridge

11, 60, 60 'biosensor chip

11a One end

12, 52 Puncture device

12a Tip

13 Sampling port

18a, 18b detection electrode

19 Convex

20, 70, 70, 80 Elastic body

21 Tip surface (surface in contact with the subject)

23 Sealed semi-open space

24 Adhesive

25 Surface in contact with biosensor chip

26 Recess

27 Adhesive

30 Biosensor device

31 Measuring instrument

40 Convex 41 recess

57, 79 engaging recess

59, 77, 87 Engaging projection

72, 82 Through hole

75, 85 engagement tool

76, 86 base

81a Perforation hole

M subject

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) shows a first embodiment according to the biosensor cartridge of the present invention. FIG. 1 (B) is a cross-sectional view taken along the line A—A, and FIG. 1 is a cross-sectional view at the position B--B in FIG. 1A, FIG. 2 is an exploded perspective view showing an example of a joint between a biosensor chip and an elastic body, and FIGS. ) Is a cross-sectional view of the joint between the elastic body and the biosensor chip, FIG. 4 is a block diagram showing an embodiment of the biosensor system of the present invention, and FIGS. 5A to 5C are biosensors according to the present invention. It is explanatory drawing which shows the sampling operation | movement of a sample using a system.

[0034] As shown in FIGS. 1A, 1B, and 2, the biosensor cartridge 10 according to the first embodiment of the present invention includes a biosensor chip 11 and one end portion 11a of the biosensor chip 11. And a puncture device 12 with a tip 12a protruding therefrom. Then, by pressing against the subject M, the sample collection port 13 provided at the tip 11a of the biosensor chip 11 and the puncture port formed in the subject M by the puncture device 12 are enclosed and sealed. The elastic body 20 forming the open space 23 is provided at the tip 11a of the biosensor chip 11, and as shown in FIGS. 2 and 3, the surface 25 of the elastic body 20 that contacts the biosensor chip 11 and the biosensor chip 11 A convex portion 19 is provided on either one of the surfaces 11a in contact with the elastic body 20 (here, for example, the biosensor chip 11), and a concave portion 26 into which the convex portion 19 is fitted is formed on the other (here, for example, the elastic body 20). Provided.

In the present invention, the puncture device 12 is a generic term for a needle, a lancet needle, a force nut, and the like. However, it is desirable to be composed of a biodegradable material. For example, a hollow needle such as an injection needle or a solid needle such as a lancet needle can be used. In addition, the puncture device may be fixed with a material such as a resin for ease of handling and ease of joining with the substrate or the spacer layer.

Yes

[0036] The biosensor chip 11 includes two substrates 16a and 16b facing each other, and a spacer layer 17 sandwiched between the two substrates 16a and 16b. Detection electrodes 18a and 18b are provided on the surface of at least one of the two substrates 16a and 16b on the spacer layer 17 side of the substrate 16a. 1 (A)! And the bottom end) are bent in an L-shape in opposite directions to maintain a predetermined distance. As shown in FIG. 3, a hollow reaction part is formed by two substrates 16a and 16b and a spacer layer 17 from the tip 11a of the biosensor chip 11 to the part where the two detection electrodes 18a and 18b face each other. 15 is formed. Blood D (see FIG. 5 (C)) as a sample collected by puncturing specimen 12 (see FIG. 5) with puncture device 12 is inserted into the hollow reaction portion 15 at the tip (bottom end in FIG. 3). A sample collection port 13 to be introduced into 15 is provided.

[0037] That is, the hollow reaction part 15 is formed of the substrates 16a and 16b and the detection electrodes 18a and 18b on both upper and lower surfaces, and a rectangular space is formed by using the spacer layer 17 cut into a predetermined shape as a side wall. Is formed. For this reason, in the hollow reaction part 15, the detection electrodes 18a and 18b are exposed, and for example, an enzyme and a mediator are immobilized in the blood D immediately above or in the vicinity of the detection electrodes 18a and 18b in the hollow reaction part 15. A reagent 14 that generates an electric current by reacting with the glucose is provided. Therefore, the hollow reaction part 15 becomes a part where the blood D such as blood taken from the sample collection port 13 undergoes a biochemical reaction with the reagent 14.

[0038] As the material of the substrates 16a and 16b and the spacer layer 17, an insulating material film is selected. As the insulating material, ceramics, glass, paper, biodegradable material (for example, polylactic acid microorganism production) Polyester, etc.), polychlorinated butyl, polypropylene, polystyrene, polycarbonate, acrylic resin, polybutylene terephthalate, polyethylene terephthalate (PET), etc., thermoplastic resin such as epoxy resin, plastic material such as UV curable resin, etc. The power S can be illustrated. A plastic material such as polyethylene terephthalate is preferred because of its mechanical strength, flexibility, and ease of chip fabrication and processing. Representative P Examples of the ET resin include Melinex Nether Tetron (trade name, manufactured by Teijin DuPont Films Ltd.), Nore Miller (trade name, manufactured by Toray Industries, Inc.), and the like.

[0039] Examples of the reagent 14 include enzymes such as glucose oxidase (GOD), glucose dehydrogenase (GDH), cholesterol oxidase, and uricase, and electron acceptors such as potassium ferricyanide, pheucene, and benzoquinone.

For example, in the case of a dalcose biosensor chip that measures the amount of dalcoose in the blood, this portion includes a glucose oxidase layer, a glucose oxidase electron acceptor (mediator) mixture layer, a glucose oxidase albumin mixture layer, or Darcosoxidase Electron acceptor Albumin mixture layer is formed. In some cases, these layers are formed by using an enzyme other than darcose oxidase, such as glucose dehydrogenase. Further, as additives, buffers such as PBS and phosphate buffer, and hydrophilic polymers such as carboxymethyl cellulose and cyclodextrin may be included in the drug.

As shown in FIGS. 2 and 3, the elastic body 20 attached to the tip 11a of the biosensor chip 11 is, for example, a cylinder having a through hole 22 for forming a sealed semi-open space 23 in the central portion. The thing of a shape can be illustrated. The through hole 22 is larger than the outer diameter of the puncture device 12 because the puncture device 12 is passed through. Further, the thickness of the elastic body 20 is set to a thickness that can reliably cover the tip of the puncture device 12. The elastic material or viscoelastic material of the elastic body 20 is not particularly limited as long as it has elasticity! /, For example, natural rubber, silicone rubber, urethane rubber, ethylene rubber, styrene rubber, synthetic isoprene Synthetic rubbers such as rubber, nitrinole rubber, chloroprene rubber and attalinole rubber, sponges such as polystyrene foam, polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polytetrafluoroethylene and perfluoro Fluoropolymers such as PFA, which is a copolymer of low alkoxyethylene and polyfluoroethylene, and thermoplastic elastomers such as ethylene acetate butyl copolymer can be used.

The rubber elastic body may be solid or hollow.

[0041] The distal end surface 21 which is a surface in contact with the subject M of the elastic body 20 is formed of an adhesive silicone rubber. It is desirable that the elastic body has a force composed of a material such as rubber or acrylic rubber, or has an adhesive 24 or is coated with the adhesive 24. The adhesive 24 is not particularly limited as long as the elasticity is not impaired. As a result, it is possible to improve the adhesion between the elastic body 20 and the subject M, prevent displacement from the puncture position, and reliably form the sealed semi-open space 23. In addition, it is desirable that the inner peripheral surface of the through hole 22 has a force using a hydrophilic material, or at least the inner peripheral surface is subjected to a hydrophilic treatment. For example, a surfactant can be suitably used. The surfactant is not particularly limited as long as it does not inhibit the enzyme reaction, and examples thereof include lecithin and saponin. This facilitates passage of blood D to be collected, and even a small amount of blood D can be reliably collected.

[0042] The sealed semi-open space 23 becomes a sealed space by pressing the elastic body 20 against the sample, and a sample can be easily collected.

As shown in FIG. 2, the shape of the convex portion 19 provided on the tip 11a of the biosensor chip 11 and the concave portion 26 provided on the upper surface 25 of the elastic body 20 and into which the convex portion 19 is fitted are cylindrical. A prismatic shape or a truncated cone shape can be exemplified. By setting it as such a shape, the convex part 19 and the recessed part 26 can be formed easily. In the following description, the circular convex portion 19 will be described as an example.

The convex portion 19 provided on the biosensor chip 11 can be formed only by the spacer layer 17, but the strength is not sufficient only by the spacer layer 17, and thus sufficient strength is expected. It is desirable to provide it on the two substrates 16a and 16b that can be formed. That is, as shown in FIG. 2, the biosensor chip 11 is composed of two substrates 16a and 16b and a spacer layer 17 sandwiched between the substrates 16a and 16b. The part 19 is also formed across the three layers 16a, 16b and 17. In addition, the convex portion 19 can be made to attach the convex portion 19 after the biosensor chip 11 is manufactured after the biosensor chip 11 is manufactured.

On the other hand, as shown in FIGS. 2 and 3, a circular recess 26 into which the protrusion 19 is fitted is provided on the surface 25 of the elastic body 20 in contact with the biosensor chip 11. The shape of the recess 26 can be formed by cutting it into a cylindrical shape as shown in FIG. 2, but in addition to this, a circular groove can be provided in which the projection 19 that is a part of the cylindrical shape is fitted. Fit the convex part 19 into the groove You may do it.

As shown in FIG. 3 (A), it is desirable that the biosensor chip 11 and the elastic body 20 are securely fixed with an adhesive 27. At this time, if there is a gap between the elastic body 20 and the biosensor chip 11, the sealed half-open space 23 can be reliably formed by applying the adhesive 27 so as to crush this gap. This is particularly necessary when blood D is sucked out using a pump or the like. Further, it is possible to prevent blood D collected from the joint from leaking. In addition, when the adhesive 27 is applied to the contact surface between the convex part 19 of the biosensor chip 11 and the concave part 26 of the elastic body 25, the part serving as the blood D flow path or the inner part of the biosensor chip 11 It is necessary to be careful not to stick out.

Next, the biosensor device according to the present invention will be described. FIG. 4 shows a configuration of a biosensor device 30 using the above-described biosensor cartridge 10.

As shown in FIG. 4, the biosensor device 30 includes a biosensor cartridge 10 and a measuring device 31 that obtains information on blood D collected by connecting to the detection electrodes 18a and 18b of the biosensor cartridge 10. And a protective cap 36 for the biosensor cartridge. Note that the configuration of the biosensor cartridge 10 is as described above, and parts that are the same as those of the biosensor cartridge 10 described above are denoted by the same reference numerals, and the description thereof is omitted here.

The measuring instrument 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 biosensor chip 11 having the biosensor force trough 10 is inserted and fixed in the terminal insertion part 34, and the detection electrode exposed at the rear end 11c of the biosensor chip 11 is fixed. 18a and 18b are electrically connected. The biosensor device 30 is small in size, for example, a subject can be held with one hand.

Next, with reference to FIGS. 5 (A) to (C), a method for using the biosensor device 30 as an example will be described with reference to a case where the blood glucose level is measured.

First, as shown in FIG. 4, the rear end l ib of the main body 11 of the biosensor cartridge 10 is inserted into the terminal insertion portion 34 of the measuring device 31 to be fixed and electrically connected. Turn on the power 32 of the biosensor device 30 and check that it is operating normally. As shown in Figure 5 (A) Hold the biosensor device 30 and press the protective cap 36 against the subject to make the puncture site congested and bring the elastic body 20 attached to the tip 11a of the biosensor cartridge 10 into contact with the blood collection location of the subject M . Since the adhesive 24 is coated on the distal end surface of the elastic body 20, it can be prevented from being displaced during subsequent operations.

Next, as shown in FIG. 5 (B), the biosensor cartridge 10 is pressed against the subject M. As a result, the elastic body 20 is crushed and the puncture device 12 projects from the tip of the elastic body 20 to puncture the subject M.

[0050] As shown in FIG. 5 (C), when the force for pressing the biosensor cartridge 10 is weakened, the elastic body 20 returns to the original state (the state shown in FIG. 5 (A)) due to the restoring force. Instrument 12 exits subject M. At this time, since the inside of the sealed semi-open space including the puncture port is negative pressure, blood D easily flows out from the puncture port. Furthermore, since the inner peripheral surface of the through-hole 22 forming the sealed semi-open space 23 is subjected to hydrophilic treatment, the blood D is sampled along the inner peripheral surface of the through-hole 22 by its surface tension and capillary phenomenon. Collected from sampling port 13. The collected blood D is introduced into the hollow reaction part 15. At this time, since the sample collection port 13 is located in the sealed semi-open space 23 together with the puncture port formed by the puncture device 12, blood D can be easily and reliably removed without moving the biosensor cartridge 10. Can be collected. For this reason, it can be used even with the subject M with reduced visual acuity, and measurement with a small amount of blood can reduce the burden on the subject at the time of blood collection. In addition, since the closed semi-open space 23 is shielded from outside air, the blood D coagulation is delayed to facilitate collection.

[0051] When a predetermined amount of blood is collected, the biosensor device 30 is separated from the subject M, and the measurement result is displayed on the display unit 35. The blood D introduced into the hollow reaction unit 15 reacts with the reagent 14, and the current value or charge value (charge amount) data measured by the detection electrodes 18 a and 18 b is sent to the control device 33. A calibration curve data table is stored in the control device 33, and the blood glucose level is calculated based on the measured current value (charge value). When the calculation is completed, the measurement result is displayed on the display unit 35. For example, the blood glucose level can be expressed as a numerical value. Finally, the force to remove the biosensor cartridge 10 from the measuring instrument 31. At this time, 弹 1. The living body 20 has returned to its original height. The protrusion 11 does not protrude from the tip 11a. Thus, the force S can be used to properly process the used biosensor cartridge 10 that is not damaged by the puncture device 12 by the user.

For puncturing, there is a case where a driving mechanism is used in addition to puncturing by pressing the biosensor cartridges 10 and 10B against the subject. Examples of the drive mechanism for puncturing a subject with a puncture device include a panel and a motor. By using these drive mechanisms, the time required for puncture can be shortened, and pain during puncture can be reduced.

[0053] In consideration of the blood collection burden of the subject, the volume of the hollow reaction part 15 is preferably 1 L (microliter) or less, particularly 300 nL (nanoliter) or less. With such a minute hollow reaction part 15, even if the diameter of the puncture device 12 is small, a sufficient blood volume of the subject can be collected. Preferably, the diameter is 1000 m or less.

As described above, according to the biosensor cartridge 10 and the biosensor device 30 described above, when one end portion 11a of the biosensor chip 11 is pressed against the subject M, the elastic body 20 is compressed and a puncture device for puncture Since 12 protrudes, the subject M can be punctured. Further, when the pressing force is weakened, the puncture device 12 is extracted from the subject M by the restoring force of the elastic body 20, and the blood D flows out from the puncture port. At this time, the puncture port and the sample collection port 13 provided at the tip 11a of the biosensor chip 11 are enclosed in a sealed half-open space 23 formed by the elastic body 20, and after the puncture, the elastic body 20 is restored to its original shape. Since the inside of the sealed semi-open space 23 becomes negative pressure when returning to the shape of the blood, blood D can be collected from a minute puncture port, and pain of the subject M can be reduced. In addition, since a small amount of blood D can be easily collected and analyzed by the sample collection port 13, it is possible to reduce the burden on the subject M with the force S.

[0055] Further, in the connecting portion between the elastic body 20 and the biosensor chip 11, the convex portion 19 is provided on one side and the concave portion 26 is provided on the other side. Can be securely attached to the predetermined position.

In addition, by preventing the puncture device 12 from protruding from the distal end surface 21 of the elastic body 20 before use, the puncture device 12 and the user can be protected. Also, the puncture device 12 should not protrude from the distal end surface 21 of the elastic body 20 when it is discarded after use. Can be disposed of safely and properly.

[0056] In addition, puncture and sample collection can be performed by a series of operations, and sample collection can be performed easily and reliably without the need to align the sample collection port 13 of the biosensor chip with the puncture port as in the prior art. Can do. In addition, since the information of blood D is transmitted to the measuring device 31 via the detection electrodes 18a and 18b, the measurement can be easily performed in a short time, so that the burden on the subject M can be reduced.

It should be noted that the biosensor cartridge of the present invention is not limited to the above-described embodiment, and can be appropriately modified and improved.

For example, in the above-described embodiment, the case where the puncture device 12 is provided in the biosensor chip 11, that is, in the spacer layer 17 sandwiched between both the substrates 16a and 16b is illustrated. 10 is not limited to this.

[0058] Next, a second embodiment of the biosensor cartridge according to the present invention will be described.

FIG. 6 (A) shows a second embodiment of the biosensor cartridge of the present invention, and FIG. 6 (B) is a cross-sectional view taken along the line A—A. FIG. 6 (B) is a diagram of the biosensor cartridge of the present invention. FIG. 7 is a cross-sectional view taken along the line BB in FIG. 6 (A) showing the second embodiment.

[0059] As shown in FIGS. 6A and 6B, the puncture device 12 may be provided along the outer surface of one of the substrates 16a. In the case of this biosensor cartridge, the thickness of the biosensor chip 11 can be reduced to form a thin biosensor cartridge. However, since the puncture device 12 and the sampling port 13 are somewhat separated from each other, the cross-sectional shape of the through-hole 22 is made oval or the like so that the outer peripheral surface of the puncture device 12 and the through-hole 22 of the elastic body 20 It is desirable to make the gap formed between the inner peripheral surface as small as possible.

[0060] Further, in this biosensor cartridge 10B, the convex portion 19 provided in the biosensor chip 11 and the concave portion 26 provided in the elastic body 20 are not in the region centering on the puncture device 12, and thus as described above. It is difficult to provide a circular shape. Therefore, for example, a semicircular convex portion 19 is provided on the side opposite to the puncture device 12 of the sample collection port 13 (upper side in FIG. 6B) so as not to obstruct the flow path of blood D. ! /

In FIG. 6, parts that are the same as those of the biosensor cartridge 10 already described are denoted by the same reference numerals, and redundant description is omitted. In the above-described embodiment, the force described in the case where the biosensor chip 11 is provided with the convex portion 19 and the elastic body 20 is provided with the concave portion 26 is illustrated in FIG. In addition to the configuration of (A), the biosensor chip 11 may be further provided with a recess 41 and the elastic body 20 may be provided with a protrusion 40. Moreover, the shape of a convex part and a recessed part is not restricted circular. For example, the recess may be a slit, and the biosensor chip 11 may be inserted into the slit. It is also possible to use the upper end portion of the through hole 22 as a recess without providing the recess 26 separately.

[0062] Furthermore, although the case where the collection is performed by the surface tension of the blood D or capillary action has been described, a device such as a pump for sucking up the blood D flowing out to the puncture port can be used.

The detection electrodes 18a and 18b may be linear as shown in FIG. 3B, which is not L-shaped.

[0063] Next, a third embodiment of the biosensor cartridge of the present invention will be described with reference to the drawings.

FIG. 7 is a cross-sectional view of a biosensor cartridge showing a third embodiment of the present invention. The biosensor force trough shown in FIG. 7 is obtained by attaching an elastic body having an engagement tool as shown in FIG. 9 attached to the tip of a biosensor chip as shown in FIG.

[0064] The biosensor chip 60 includes two electrically insulating substrates 50a and 50b formed on one side of a flat plate sensor unit 50 formed by shelling together with an adhesive or the like on the substrate 50b of the puncture instrument 52. The needle support part 55 attached so that the front-end | tip protrudes is stacked, and the mounting part 56 is stacked on the board | substrate 50a which comprises the opposite side surface of the flat sensor part 50, and is comprised. The needle support portion 55 and the mounting portion 56 are each provided with an engagement recess 57 for engaging the engagement tool 75.

In FIG. 8, reference numeral 50c denotes an adhesive part. At the tip of the detection unit 50, there is a square part to which no adhesive is applied, and this square non-adhesive part forms a hollow reaction part 53 for inhaling a liquid sample such as blood. 53a is an entrance of the hollow reaction part 53. A pair of detection electrode patterns 54 are printed on the surface of the insulating substrate 50a to which the adhesive is applied, and the pair of electrodes 54 are arranged so as to cross the hollow reaction portion 53. Is drawn. In addition, a reagent that reacts with a liquid sample such as blood enters the hollow reaction part 53. It has been applied. Therefore, the liquid sample sucked into the hollow reaction part 53 reacts with the reagent, and the potential and current changes caused by the chemical change can be detected by the pair of electrodes 54. For example, when blood as a liquid sample is inhaled into the hollow reaction part 53, the potential change caused by the reaction with the reagent is detected by the electrode 54 so that the measurement part can measure a desired characteristic such as blood glucose level. It has become.

[0066] The elastic body 70 is a cylindrical body having a through hole 72 serving as a flow path, and an engagement tool 75 is fixed to the biosensor chip 60 side. The engaging tool 75 is provided with three pins as the engaging convex portions 77 having the tip tapered portions 77a on the upper surface of the ring-shaped base 76. The hole 75a is sized to allow the puncture device 52 to pass therethrough and to communicate with the reaction portion entrance 53a. The hole 75a communicates with the through hole 22 of the flow path forming body 20 so as to communicate from the tip of the puncture device 52 to the reaction portion entrance 53a. A flow path that communicates up to

[0067] The elastic body 70 is made of an elastic material that can be compressed or deformed by a pressure applied in the puncture direction and can be restored to its original shape by releasing the pressure. Thus, when the elastic body 70 is compressed or deformed by the pressure in the puncturing direction of the puncture device 52, the tip of the puncture device 52 can protrude from the bottom surface of the elastic body 70.

The base 76 may be made of a hard material such as metal or hard plastic, and the engaging protrusion 77 may be integrally made of the same material as the base 76. Alternatively, the base 76 is made of a hard material, and the engaging convex portion 77 is made of a material that is softer than the base 76 but does not deform due to the pressing force of the base 76. May be fixedly attached to the base 76.

[0069] Since the elastic body 70 and the engagement tool 75 are integrally fixed by an adhesive or the like, the base 76 is gripped, and the engagement protrusion 57 is engaged with the engagement recess 57 at the tip of the biosensor chip 60. By press-fitting 77, the engaging tool 75 and the elastic body 70 can be attached and fixed to the biosensor chip 60. When mounting and fixing the elastic body 70, it is only necessary to grip the base 76 and insert it into the engagement recess 57! /, So handling! / Is soft and inconvenient! / It is possible to carry out by a simple operation of insertion, and it is possible to secure the mounting accuracy of the elastic body that is soft and difficult to secure the mounting accuracy by the engagement and fixing using the pin.

[0070] A method of using the biosensor cartridge having the above configuration will be described. The biosensor cartridge of the present invention is attached to a measuring instrument 90 having a display unit 91, a measuring unit 92, a puncture panel 93, and a panel operation button 94 as shown in FIG. . At the time of mounting, the sensor mounting portion 56 of the nano sensor chip 60 is inserted into a setting portion (not shown) of the measuring instrument, whereby the puncture panel 93 is compressed. Then, by pressing the panel operation button 94, the panel 93 is released from the compressed state, and accordingly, the biosensor chip 60 can be driven in the puncturing direction. 90a is a casing.

[0071] With the puncture panel compressed (panel biased state), the bottom surface of the elastic body 70 or the casing 90a is pressed against the skin of the subject, for example, a finger. Next, when the operation button is pushed in the direction in which the spring holding the puncture device 52 extends, the biosensor chip 60 is pushed out toward the skin. Along with this, a pressure in the puncture direction is generated in the elastic body 70 attached to the tip of the biosensor chip 60, and the elastic body 70 is deformed so as to compress in the puncture direction or expand in the radial direction. Since the puncture device 52 attached to the tip of the biosensor chip 60 is pushed toward the skin in the deformed state of the elastic body 70, the puncture device 52 protrudes from the bottom surface of the elastic body 70 and punctures the skin. Next, when the urging by the panel is released, the elastic body 70 returns to its original shape by the original restoring force, and accordingly, the puncture device 52 is pulled out from the skin, and the elastic body 70 flows into the flow path of the elastic body 70. Will be stored. A blood droplet exudes from the site punctured by the puncture device 52 and rises in the flow path along the puncture device 52 or by capillary action. The blood sucked up to the tip of the biosensor chip 60 is further introduced into the hollow reaction part 53 through the reaction part inlet 53a.

[0072] As described above, in the biosensor cartridge of the present embodiment, the liquid sample is passed through the air reaction part 53, despite the fact that the tip of the puncture instrument 52 and the reaction part inlet 53a are arranged at a distance from each other. It becomes possible to introduce in.

[0073] Note that the shapes of the engaging convex portion and the engaging concave portion are not limited to the above-described embodiments, and may be a simple pin or a tip key shape. Further, the number of engaging portions is three in the above embodiment, but the present invention is not limited to this, and any number may be used as long as the elastic body can be stably attached and fixed to the biosensor chip. Further, the engagement by the unevenness is not limited to the above embodiment, and the engagement recess is formed in the engagement tool, and the engagement protrusion is formed in the biosensor chip. May protrude.

[0074] In the above-described embodiment, the elastic body and the engagement tool are integrated. However, the biosensor cartridge of the present invention is not limited to this. The elastic body and the engagement tool may be configured separately.

[0075] Furthermore, in the above embodiment, the diameter of the hole 75a and the through-hole 72 serving as the flow path is a force that includes the puncture device 52 and the reaction portion entrance 53a, and the biosensor cartridge of the present invention is Not limited to this! The diameter of the flow path portion may be set to a diameter that allows the puncture instrument 52 to move relatively.

[0076] Next, a fourth embodiment of the biosensor cartridge of the present invention will be described.

The biosensor cartridge shown in FIG. 11 is obtained by attaching and fixing the inertia member 80 to the biosensor chip 60 using the elastic body 80 (FIG. 12) and the engaging tool 85 (FIG. 13) configured separately. . Since the configuration of the biosensor chip 60 is the same as that of the third embodiment, the description thereof is omitted.

[0077] The engagement tool 85 is configured such that three stop pins as the engagement protrusions 87 are erected on the upper surface of a ring-shaped base 86 made of metal or hard plastic. 85a is a hole in the ring.

The lower surface side of the elastic body 80 has a double ring structure of an inner wall 80a and an outer wall 80b. The outer wall 80b constitutes the peripheral wall of the elastic body 80, and the bottom surface of the outer wall 80b is the bottom surface of the elastic body 80. It is. On the other hand, the inner wall 80a constitutes the peripheral wall of the through hole 82 serving as a flow path, and the bottom surface of the inner wall 80a is formed slightly above the bottom surface of the outer wall 80b. Therefore, when the bottom surface of the elastic body 80 (the bottom surface of the outer wall 80b) is brought into contact with the subject, a slight space S is formed between the inner wall 80a and the contact surface. Further, the outer wall 80b has two openings 84 that are notched at opposite positions, so that the elastic body 80 (outer wall 80b) is brought into contact with the subject via the space S. Thus, the outside of the elastic body 80 and the inside of the flow path 82 can communicate with each other.

[0079] On the upper surface of the elastic body 80, a fitting portion 81 into which the tip of the biosensor chip 60 is fitted is recessed, and a through-hole penetrating from the bottom surface of the fitting portion 81 to the bottom surface of the elastic body 80. 82 is provided, and the puncture device 52 is inserted therein so as to be relatively movable. In addition, a hole 81a that penetrates to the circumferential groove 80c that is provided between the inner wall 80a and the outer wall 80b of the elastic body 80 is provided in the bottom surface of the fitting portion 81. The engagement projection 87 of the engagement tool 85 is I am able to pass.

[0080] In addition, the elastic body 80 is provided with an air passage 83 communicating with the through hole 82 and the outer peripheral surface of the inertia member 80 so as to pass through the reaction portion entrance 53a. The rising liquid sample can flow into the hollow reaction part 53.

The engaging tool 85 is set in the circumferential groove 80c of the elastic body having the above configuration. That is, the inner wall 80a is passed through the ring hole 85a of the engaging tool 85, and the engaging convex portion 87 is passed through the hole 81a. The elastic body 80 may be attached to the biosensor chip 60 by inserting the engaging convex portion 87 into the engaging concave portion 57 of the biosensor chip 60, or the fitting portion 81 of the elastic body 80 may be attached to the biosensor chip 60. The base 86 of the engagement tool 85 may be inserted into the circumferential groove 80c after being temporarily attached to the distal end of the engagement tool 85. In any method, the engaging projection 87 can be attached and fixed by engagement only by fitting into the engaging recess 57. Compared to the case where the elastic body 80 that is soft and inconvenient is directly attached and fixed. Convenient.

[0082] As in the case of the third embodiment, the biosensor cartridge having the above-described configuration can be used by being mounted on the measuring instrument shown in FIG. A space S exists in contact with the subject (skin), and the through-hole 82 serving as the flow path is formed by the elastic body 80 by the opening 84 and the air passage 83 provided in the outer wall 80b. The outside is in communication. Next, when the operation button is pushed in the direction in which the panel holding the puncture device 52 extends, the biosensor chip 60 is pushed out toward the skin. Along with this, a pressure in the puncture direction is generated on the elastic body 80 attached to the tip of the biosensor chip 60, the elastic body 80 is deformed, and the puncture device 52 protrudes to puncture the skin. Next, when the urging by the panel is released, the elastic body 80 returns to its original shape with the original restoring force, and accordingly, the puncture device 52 is extracted from the skin and stored in the through hole 82. Will be. When the elastic body 80 returns to the original state, the space S again exists, so that the atmosphere from the outside is introduced into the through-hole 82, and further, due to the air flow and capillary action through the air passage 83. In addition, the force of the site punctured by the puncture device 52 can also rise in the blood droplet force S and the inside of the through-hole 82. The liquid sample that has reached the ceiling surface (front end surface of the sensor main body) of the through-hole 82 flows toward the air passage 83 along the air flow, and is introduced into the hollow reaction part from the reaction part inlet 53a. The liquid sample flowing into the air passage 83 is preferentially introduced into the hollow reaction part 53 rather than out of the elastic body 80. As described above, it is preferable to adjust the size appropriately in relation to the hollow reaction part 53, or to apply a surfactant or the like to the reaction part inlet 53a.

[0083] As described above, the biosensor cartridge of the fourth embodiment is also arranged at a position where the tip of the puncture instrument 52 and the reaction portion entrance 53a are spaced apart from each other as in the biosensor chip of the third embodiment. Nevertheless, it is possible to introduce the liquid sample discharged by the puncture into the hollow reaction part 53. Further, the mounting and fixing of the elastic body 80 is substantially performed by the fitting operation of the engaging tool 85, so that the requirement for the accuracy of the fitting portion in the fitting portion 81 can be reduced.

[0084] In each of the above embodiments, the elastic body is attached and fixed to the biosensor chip by using the engaging tool. However, the present invention is not limited to the case where the engaging tool is used. For example, when the elastic body is made of a material having strength and hardness that can be fixed and fixed by engagement, an engagement recess or engagement protrusion provided in the needle support or mounting portion of the biosensor chip. An engaging convex portion or an engaging concave portion that can be engaged with the elastic member may be provided directly on the elastic body. In addition, since the present invention only requires that the elastic body can be attached and fixed to the biosensor chip by engagement, the engagement portion is provided outside the biosensor chip and the elastic body! /

FIG. 14 shows a fifth embodiment of the biosensor cartridge of the present invention. This biosensor cartridge has an engaging convex portion 59 projecting on the surface of the biosensor chip 60 ′ on which the elastic body 70 ′ is attached, and an engaging concave portion 79 into which the engaging convex portion 59 can be fitted. It is recessed directly on the elastic body 70 '. By configuring the engaging convex portion 59 integrally with the biosensor chip 60 ′ (needle support portion 55 and mounting portion 56) made of a hard material, a force S for ensuring the engagement strength can be obtained. Since the configuration other than the engaging portion in the fifth embodiment is the same as that of the third embodiment, the description thereof is omitted by attaching the same reference numerals.

[0086] In the embodiment of V and displacement, both of the fitting part and the biosensor chip tip part are formed in a circular cross section. However, the biosensor cartridge of the present invention has the fitting part and The shape of the fitting part at the tip of the biosensor chip is not particularly limited. Since it is attached and fixed by engagement, any shape that can provide an engagement portion and can secure a flow path from the subject contact surface to the reaction portion entrance is acceptable.

[0087] Further, in the above embodiment, the insulating base to which the puncture device is not attached Force with which an electrode was provided on the plate In the biosensor cartridge of the present invention, the positional relationship between the puncture device mounting position and the electrode substrate is not limited! /. The electrode may be provided on the substrate on the puncture device mounting side, and the positive electrode and the negative electrode do not need to be provided on the same substrate. One substrate may be provided with a positive electrode and the other substrate may be provided with a negative electrode. Furthermore, the biosensor chip has a configuration in which two substrates are bonded together. For example, as disclosed in International Publication 2005-010519, a pair of electrodes are arranged on one substrate, and the electrodes are arranged on the inner side. You may comprise by bending so that it may become.

[0088] Furthermore, in the biosensor cartridge of the above embodiment, the biosensor chip has a flat plate shape. However, the present invention is not limited to this, and the biosensor chip may have a cylindrical shape. May also be cylindrical. The attachment position of the puncture device is not limited, and the puncture device may be attached in the hollow reaction part. In this case, the electrode is disposed so as not to contact the puncture device, and the reagent is applied so as to communicate with the electrode and the hollow reaction.

[0089] Although the present 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. It is.

This application is based on a Japanese patent application filed on August 22, 2006 (Japanese Patent Application No. 2006-224993) and a Japanese patent application filed on February 24, 2007 (Japanese Patent Application No. 2007-044782). The contents are incorporated herein by reference.

Industrial applicability

As described above, since the biosensor cartridge according to the present invention is provided with an elastic body at the tip end of the biosensor chip, the puncture device is extracted by the restoring force of the elastic body after puncturing, and formed by the elastic body. Since a sample can be collected from the sealed half-open space, even a small amount of sample can be easily collected through the sample collection port. In addition, at the connecting portion between the elastic body and the biosensor chip, a convex portion is provided on one side and a concave portion is provided on the other side to be fitted! /, So that the elastic body can be securely placed at a predetermined position of the biosensor chip. It is useful as a biosensor cartridge for measuring and analyzing chemical substances using the reagent contained in the hollow reaction part of the chip.

Claims

The scope of the claims

[1] A biosensor cartridge comprising a biosensor chip and a puncture device that is fixed to a part of the biosensor chip and has a protruding tip.

An elastic body that encloses a sample collection port provided at the tip of the biosensor chip and a puncture port formed in the subject by the puncture device to form a space necessary for sample collection, At the tip of the tip,

A biosensor cartridge, wherein a surface of the elastic body that contacts the biosensor chip and a surface of the biosensor chip that contacts the elastic body are fitted by an uneven structure.

[2] By means of the sealed semi-open space, the sample collection port provided at the tip of the biosensor chip is connected to the puncture port formed in the subject by the puncture device! The biosensor cartridge according to claim 1, wherein the cartridge is a biosensor cartridge.

[3] The convex portion is provided on the biosensor chip and the concave portion is provided on the elastic body, and the convex portion has a columnar shape, a prismatic shape, or a truncated cone shape. The biosensor force trilogy described in 1.

[4] The force according to any one of claims 1 to 3, wherein the convex portion of the biosensor chip and the concave portion of the elastic body are fitted by a stretching force of the elastic body. Biosensor cartridge.

[5] A concave portion is provided on a side of the biosensor chip to which the elastic body is attached, and an engaging tool having a convex portion that fits into the concave portion is integrally provided on the biosensor chip attachment side of the elastic body. The biosensor cartridge according to claim 1, wherein the biosensor cartridge is attached to the cartridge.

[6] An engaging tool having a concave portion on the side to which the elastic body of the biosensor chip is attached and having a convex portion that fits into the concave portion is configured separately from the elastic body, 2. The elastic body is provided with a hole through which the convex portion passes so that the engaging tool can be attached from the subject contact side of the elastic body. The biosensor cartridge according to 1.

7. A drive mechanism for puncturing the subject with the puncture device. The biosensor cartridge according to any one of -6.

[8] The biosensor cartridge according to any one of [1] to [7], wherein at least a surface of the elastic body in contact with the subject has adhesiveness.

9. The biosensor force cartridge according to any one of claims 1 to 8, wherein the elastic body and the tip of the biosensor chip are fixed with an adhesive or a double-sided tape.

[10] The puncture is performed by pressing the elastic body against the specimen and compressing it, collecting a sample while forming a flow path, and removing the puncture device from the subject by the restoring force of the elastic body. The biosensor cartridge according to any one of claims 1 to 9, wherein:

[11] The power of any one of claims 1 to 10, comprising the biosensor cartridge according to 1, and a measuring device that obtains information on a sample collected by connecting to the detection electrode of the biosensor cartridge. A biosensor device characterized.