WO2008062648A1

WO2008062648A1 - Biosensor cartridge and biosensor apparatus

Info

Publication number: WO2008062648A1
Application number: PCT/JP2007/071332
Authority: WO
Inventors: Tsuyoshi Fujimura; Hideaki Nakamura; Tomoko Ishikawa; Masao Gotoh; Isao Karube; Shingo Kaimori; Takahiko Kitamura; Hiroto Nakajima; Hiroshi Hayami; Toshifumi Hosoya
Original assignee: National Institute Of Advanced Industrial Science And Technology; Sumitomo Electric Industries, Ltd.
Priority date: 2006-11-21
Filing date: 2007-11-01
Publication date: 2008-05-29
Also published as: JP4894039B2; JP2008125813A

Abstract

This invention provides a biosensor cartridge, which can reduce the amount of a sample, to be collected, necessary for measurement to reduce a burden on users and can easily collect the sample, through a punctured port without the need to provide the step of allowing a sample collection port to approach the punctured port, for the measurement, and a biosensor apparatus. A sample collection port (13) provided at one end of a biosensor chip (11) is open in a direction which crosses an axis line of a puncturing tool (12). By virtue of this constitution, the sample collection port (13) can be allowed to approach to a punctured port formed by the tip of the puncturing tool (12) to a nearer position to the punctured port than the position attained by the prior art technique. According to the above constitution, even a small amount of a sample can easily be collected through the sample collection port (13), and a reliable examination can be carried out.

Description

Specification

Biosensor cartridge and biosensor device

Technical field

The present invention relates to a biosensor cartridge, for example, a biosensor cartridge and a biosensor device that measure and analyze a chemical substance using a reagent contained 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. 6 is an exploded perspective view showing the glucose sensor described in Patent Document 1. FIG. As shown in FIG. 6, a glucose sensor 100 as a biosensor has a counter electrode 101 and a working electrode 102. The counter electrode 101 has a hollow needle shape cut in half in the length direction, and a distal end portion 103 thereof is obliquely cut into an injection needle shape so as to 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 working electrode 102 is attached via '. The working electrode 102 is a flat plate member to which glucose oxidase (GOD) is immobilized. The so-called immobilized GOD105 surface on which the GOD is immobilized is adhered to the counter electrode 101 with the surface side 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).

7A is a perspective view of the sensor described in Patent Document 2, and FIG. 7B is an exploded perspective view of the sensor. As shown in FIG. 7, the lancet-integrated sensor 110 has a chip body 111, a lancet 113, and a protective cannula 115, and is laid out. The chip body 111 (the board 111a and the substrate 111b can be opened and closed, and the inner space 112 is formed on the inner surface of the cover 111a. Is formed. 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 biosensor 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.

[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 puncture the sample collection port. It is an object of the present invention to provide a biosensor cartridge and a biosensor device capable of performing a more accurate measurement as much as possible by easily collecting and measuring a sample of a puncture mouth without requiring an operation to bring the mouth close.

Means for solving the problem

[0008] In order to achieve the above-described object, a biosensor force cartridge according to the first feature of the present invention includes a biosensor chip having a sample collection port for collecting a sample at a tip portion, and the biosensor chip. A biosensor cartridge having a puncture device fixed to the puncture device, wherein the sample collection port is opened in a direction intersecting the axis of the puncture device.

In the biosensor cartridge configured as described above, since the sample collection port can be made closer to the puncture port formed by the tip of the puncture device than before, a small amount of the sample collection port can be obtained. This sample can be easily collected through the sampling port, and a reliable inspection can be performed.

[0010] In addition, the biosensor cartridge that is the second feature of the present invention is characterized in that, in the first feature of the present invention, the sampling port is provided at a corner of the tip of the biosensor chip. It is what.

In the biosensor cartridge configured as described above, when the puncture device support and the biosensor chip are integrated, the sample collection port and the puncture device are brought close to each other with a force S.

In addition, it is preferable that an inclined angle portion is formed at the corner of the tip of the biosensor chip, and a sample collection port is provided at the inclined angle portion.

By adopting this configuration, the sample collection port of the biosensor chip and the puncture device are brought closer to each other, and even a small amount of sample can be easily guided to the sample collection port.

[0011] In addition, the biosensor cartridge which is the third feature of the present invention is the biosensor cartridge according to the first or second feature of the present invention described above, wherein the puncture instrument support is configured to attach the biosensor chip. It is integrated with the biosensor chip so as to be sandwiched from the front and back. In the biosensor cartridge configured as described above, the puncture instrument support and the biosensor chip are combined and integrated, and the sample collection port and the tip of the biosensor chip are easily close to each other.

[0012] In addition, the biosensor cartridge that is the fourth feature of the present invention is the biosensor chip and the puncture device support according to any one of the first to third features of the present invention. The tip of the puncture device is provided with an elastic body that encloses a puncture opening formed in the subject by the tip of the puncture device and forms a space necessary for sample collection. In the biosensor cartridge, at the time of puncture, the puncture port and the sample collection port provided at the tip of the biosensor chip are connected by a space formed by an elastic body. Can be collected

Yes

Further, according to this biosensor cartridge, it is possible to prevent the puncture device from protruding from the distal end surface of the elastic body before use, thereby protecting the puncture device and protecting the user. Can do. Furthermore, it is possible to prevent the puncture device from protruding from the distal end surface of the elastic body when it is discarded after use, and this allows safe and proper disposal with the force S.

[0013] In addition, the biosensor cartridge that is the fifth feature of the present invention is characterized in that, in the fourth feature of the present invention, at least the distal end surface of the elastic body has adhesiveness.

In the biosensor cartridge configured as described above, since at least the tip surface of the elastic body has adhesiveness, the surface in contact with the subject has adhesiveness, and the elastic body is in close contact with the subject. Therefore, it is possible to prevent the puncture position from shifting and to ensure the sample collection.

It should be noted that the elastic body is not limited to the case where only the tip surface has adhesiveness, but when the elastic body itself has adhesiveness or when the adhesive is kneaded into the elastic body, it is coated with the adhesive. The method etc. are mentioned.

[0015] Further, the biosensor device which is the sixth feature of the present invention is characterized by the biosensor force trig- gy of the above-mentioned configuration of the present invention; Sensor force And a measuring instrument for obtaining information of a sample collected by connecting to a detection electrode.

[0016] In the biosensor device configured as described above, since the sample is collected by the biosensor cartridge described above, puncture and 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. In addition, by transmitting the sample information to the measuring device via the detection electrode, the measurement can be easily performed in a short time, so that the burden on the subject can be reduced.

The invention's effect

[0017] According to the present invention, since the sample collection port provided at one end of the biosensor chip and the axis of the puncture device are configured to intersect at an appropriate angle, the sample collection port is used as the puncture port. Since they can be very close to each other, it is possible to provide a biosensor cartridge and a biosensor device that can easily collect even a small amount of sample through the sample collection port and can perform a reliable test.

Brief Description of Drawings

FIG. 1 (A) is an explanatory diagram of a schematic longitudinal section in an embodiment of a biosensor cartridge according to the present invention. (B) is an explanatory diagram of a substantially horizontal cross section in an embodiment of a biosensor cartridge according to the present invention.

FIG. 2 is an exploded perspective view in which an elastic body and a biosensor chip are disassembled in an embodiment of a biosensor cartridge according to the present invention.

FIG. 3 is a cross-sectional view showing a main part in an embodiment of a biosensor cartridge according to the present invention.

FIG. 4 is a schematic 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 by using the biosensor device which is effective in the present invention.

FIG. 6 is an exploded perspective view showing a conventional biosensor chip.

FIG. 7 (A) is a perspective view showing a conventional biosensor chip. (B) is an exploded perspective view showing a conventional biosensor chip.

Explanation of symbols [0019] 10 Biosensor cartridge

11 Biosensor chip

11a Tip of biosensor chip

l ib Inclination angle

12 Puncture device

12a Tip of puncture device

13 Sampling port

15 Hollow reaction part

18a, 18b detection electrode

20 Elastic body

21 Tip surface (surface in contact with the subject)

22 Through hole

23 Sealed semi-open space (space)

24 Adhesive

25 Surface in contact with biosensor chip

26 Raised

28 Puncture device support

28a Tip of puncture device support

30 Biosensor device

31 Measuring instrument

D Blood (sample)

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) is a longitudinal sectional view of the essential part of the embodiment of the biosensor cartridge of the present invention as seen from the side, and FIG. 1 (B) is the elasticity in the embodiment of the biosensor cartridge of the present invention. Fig. 2 is a view from the tip direction with the body removed (viewed in the direction B in Fig. 1 (A)). FIG. 2 is an exploded perspective view of the biosensor chip and the elastic body. Figure 3 shows the It is a principal part expanded sectional view in Ming embodiment. FIG. 4 is a block diagram showing an embodiment of the biosensor device of the present invention. 5 (A) to 5 (C) are a series of explanatory views showing a sample collecting operation using the biosensor device which is effective in the present invention.

As shown in FIG. 1, a biosensor cartridge 10 according to an embodiment of the present invention includes a biosensor chip 11 having a sample collection port 13 for collecting a sample at the tip, a puncture device support 28, and the like. It is the structure which was combined and integrated. The puncture device support 28 has a puncture device 12 fixed to one end thereof. The puncture device support 28 is integrated with the biosensor chip 11 so that the tip 12a of the puncture device 12 protrudes from the tip 11a side of the biosensor chip 11 and sandwiches the biosensor chip 11. Yes. An elastic body 20 is provided so as to surround the puncture device 12. Furthermore, an inclined angle portion l ib having an angle of approximately 45 degrees is formed at the corner of the tip 11a of the biosensor chip 11, and the sample collection port 13 is opened at the inclined angle portion l ib. The opening of the sampling port 13 faces the puncture device 12 and faces it.

Also, as shown in FIGS. 2 and 3, the center line F of the hollow reaction part 15 constituting the opening of the sample collection port 13 and the axis C of the puncture device 12 intersect with each other at an angle of about 45 degrees, for example. It is in place.

As described above, the sample collection port 13 is provided at the inclined corner portion l ib formed at the corner of the tip 11a of the biosensor chip 11, so that the puncture instrument support 28 and the biosensor chip 11 are provided. When it is integrated, it is easy to bring the sampling port 13 and the puncture device 12 into a very close state.

In the present embodiment, the puncture device support 28 is integrated so as to sandwich the biosensor chip 11 from the front and back sides thereof. In the biosensor cartridge 10 configured in this manner, the puncture device support 28 can be held so as to sandwich the relatively thin biosensor chip 11, so that the biosensor chip 11 can be easily held firmly. It is easy to combine and integrate both members.

[0024] Further, the elastic body 20 is formed with a sealed semi-open space 23 that encloses a puncture opening formed in the subject M by the puncture device 12. Further, as shown in FIGS. 2 and 3, the elastic body 20 includes the tip 1 la of the sensor chip 11 and the tip of the puncture device support 28. The surface 25 in contact with the end 28a is joined by an adhesive or the like.

[0025] In the present invention, puncture device 12 is a generic term for a needle, a lancet needle, a force needle, and the like, and is preferably composed of a biodegradable material! /.

[0026] 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 the at least one substrate 16a of the two substrates 16a and 16b on the spacer layer 17 side. (A)! And the bottom end) are bent in a substantially slanted L-shape slightly in the opposite direction to maintain a predetermined distance.

[0027] As shown in Fig. 3, the biosensor chip 11 includes two substrates 16a, 16b extending from the inclined angle portion l ib of the tip 11a to a portion where the two detection electrodes 18a, 18b face each other. And the hollow reaction part 15 is formed by the spacer layer 17.

One end of this hollow reaction part 15 (! /, One end on the left side in FIG. 3) opens to the inclined angle part 11b to constitute the sampling port 13. That is, blood D (see FIG. 5C) collected by puncturing the subject M with the tip 12a of the puncture device 12 is introduced from the sample collection port 13 to the hollow reaction unit 15.

[0028] The hollow reaction part 15 is formed by the substrates 16a and 16b and the detection electrodes 18a and 18b on both upper and lower surfaces, and the spacer layer 17 cut into a predetermined shape has a side wall of about 45 degrees (center). A rectangular space is formed in which the line F is inclined at approximately 45 degrees. In the hollow reaction part 15, the detection electrodes 18a and 18b are appropriately exposed. For example, an enzyme and a mediator are fixed immediately above or in the vicinity of the detection electrodes 18a and 18b in the hollow reaction part 15 in the blood D. A reagent 14 is provided that reacts with the glucose to generate an electric current. Therefore, the hollow reaction part 15 is a part where, for example, blood D, which is a sample collected from the sample collection port 13, undergoes a biochemical reaction with the reagent 14.

[0029] 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), polychlorinated butyl, polypropylene, polystyrene, polycarbonate, acrylic resin, polybutylene terephthalate, polyethylene terephthalate (PET) and other thermoplastic resins, epoxy resins and other thermosetting resins, UV curable resins and other plastics. The ability to exemplify materials A plastic material such as polyethylene terephthalate is preferred because of its mechanical strength, flexibility, and ease of chip fabrication and processing. Typical PET resins include Melinex Nya Tetron (trade name, manufactured by Teijin DuPont Films Ltd.), Nore Miller (trade name, manufactured by Toray Industries, Inc.), and the like.

[0030] Examples of the reagent 14 include enzymes such as glucose oxidase (GOD), glucose dehydrogenase (GDH), cholesterol oxidase, uricase, and electron acceptors. For example, dulcose for measuring the amount of darcose in blood. In the case of a biosensor chip, a glucose oxidase layer, a glucose oxidase electron acceptor (mediator) mixture layer, a glucose oxidase albumin mixture layer, a darcos oxidase electron acceptor albumin mixture layer, or the like is formed in this portion. In some cases, these layers are formed by using an enzyme other than darcose oxidase, such as glucose dehydrogenase. Further, a buffering agent, a hydrophilic polymer or the like may be included in the drug as an additive.

As shown in FIGS. 2 and 3, the elastic body 20 attached to the tip 11a of the biosensor chip 11 and the tip 28a of the puncture device support 28 has, for example, a sealed semi-open space 23 in the center. The cylindrical thing which has the through-hole 22 for forming can be illustrated. The through hole 22 is configured to allow the puncture device 12 to pass through and to allow the sample (blood D) to reach the sample collection port 13.

Accordingly, in the sealed semi-open space 23, the through hole 2 is formed to be slightly larger than the outer diameter of the puncture device 12 (inner diameter W1), and further, from the space force through hole 22 on the specimen M side (lower side in the figure). Also configured with a larger inner diameter (W2)!

[0032] When the opening of the sealed semi-open space 23 is configured to be large, the positional relationship necessary for collecting the sample D can be reliably maintained between the puncture port and the open space of the insulator 20 at the time of puncturing. Also, unexpected contact due to misalignment between the sample D and the elastic body 20 is avoided, and troubles such as the sample D oozing out to the contact portion can be avoided.

[0033] Further, the sealed semi-open space 23 has a so-called through-hole 22 in which the so-called through-hole 22 has a raised portion 26 in which the wall surface around the through-hole 22 is raised. According to this configuration, the sealed half The blood D that has flowed into the open space 23 first contacts the raised portion 26 around the through hole 22 and is guided to the through hole 22. Therefore, since blood D first contacts the location near the through hole 22 in the sealed semi-open space 23, the introduction of blood D into the sampling port 13 can be stabilized, and the blood D can be unexpectedly exposed to the outside. Bleeding can be prevented.

Further, the thickness (t) of the elastic body 20 is configured to be able to reliably cover the tip 12 a of the puncture device 12.

[0035] The material of the elastic body 20 is not particularly limited as long as it has elasticity. However, the elastic body 20 is made of a polymer such as silicone, urethane, acrylic rubber, or a single polymer or copolymerized polymer such as ethylene or styrene. Rubber or sponge, polyethylene such as polyethylene and polypropylene, polyester such as polyethylene terephthalate and polybutylene terephthalate, polytetrafluoroethylene and PFA which is a copolymer of perfluoroalkoxyethylene and polyfluoroethylene, etc. Can be used.

The elastic body 20 may be solid or hollow.

[0036] At least the distal end surface 21 of the elastic body 20 that is in contact with the subject M has a force composed of a material such as adhesive silicone rubber or acrylic rubber, and the elastic body has the adhesive 24. It is desirable to have or be coated with adhesive 24. The adhesive 24 is not particularly limited as long as the elasticity is not impaired. As a result, the adhesion between the elastic body 20 and the subject M can be improved, the puncture position force can be prevented from shifting, and the sealed semi-open space 23 can be reliably formed. 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. This facilitates passage of blood D to be collected, and even a small amount of blood D can be reliably collected.

[0037] It is desirable that the sensor chip 11 and the puncture device support 28 and the elastic body 20 are securely fixed with an adhesive. At this time, when a gap is formed between the elastic body 20 and the biosensor chip 11 and the puncture device support 28, a force S can be ensured by applying an adhesive so as to crush the gap. . Further, this adhesive can prevent blood D collected from the joint from leaking.

In the case where an adhesive is applied to the contact surface between the biosensor chip 11 and the puncture device support 28 and the elastic body 20, the portion serving as the blood D flow path or the biosensor chip 1 1 It is necessary to pay attention so that it does not protrude into the interior.

Next, a biosensor device according to the present invention will be described.

FIG. 4 shows a configuration of a biosensor device 30 using the biosensor cartridge 10 described above.

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.

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.

[0039] 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 portion 11c of the biosensor chip 11 of the biosensor force trough 10 is inserted and fixed in the terminal insertion portion 34, and the detection electrode 18a exposed at the rear end portion 11c of the biosensor chip 11 is fixed. 18b are electrically connected. The biosensor device 30 is small in size, for example, a subject can be held with one hand.

[0040] Next, with reference to (A) to (C) of FIG. 5, a method of using the biosensor device 30 as an example of measuring blood glucose levels will be described.

First, as shown in FIG. 4, the rear end portion 11c of the biosensor chip 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.

[0041] Then, as shown in FIG. 5A, the biosensor device 30 is held, the protective cap 36 is pressed against the subject, the puncture site is congested, and the biosensor cartridge 10 is attached to the tip 11a of the biosensor cartridge 10. The elastic body 20 is brought into contact with the blood collection point of the subject M. Here, since the pressure sensitive adhesive 24 is coated on the tip surface 21 of the elastic body 20, the positional shift is prevented in the subsequent work.

[0042] Next, as shown in FIG. 5B, the biosensor cartridge 10 is pressed against the subject M. I will. As a result, the elastic body 20 is crushed and the distal end 12a of the puncture device 12 protrudes from the distal end of the elastic body 20 to puncture the subject M.

[0043] Thereafter, the force pressing the biosensor cartridge 10 is weakened. By weakening this pressing, as shown in FIG. 5C, the elastic body 20 returns to its original state (the state of FIG. 5A) by its restoring force. As a result, the tip 12a of the puncture device 12 is removed from the subject M. At this time, since the inside of the sealed semi-open space 23 including the puncture port is temporarily under negative pressure, blood D easily flows out from the puncture port.

Further, since the inner peripheral surface of the through hole 22 is subjected to a hydrophilic treatment, the blood D is guided to the sampling port 13 along the inner peripheral surface of the through hole 22 and the puncture device 12 by the surface tension and capillary action. Collected. 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, the blood D can be easily and reliably collected without moving the biosensor cartridge 10. Can be collected.

In this way, since a series of operations from the puncture operation to blood D collection can be performed with one operation, for example, it is easy to use even the subject M with reduced visual acuity, and measurement with a small amount of blood is possible. The burden on the subject at the time can be reduced. Furthermore, since the sealed semi-open space 23 is shielded to some extent from outside air, the coagulation of the blood D is delayed to facilitate collection.

When a predetermined amount of blood is collected as described above, 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 device 31. At this time, the elastic body 20 has returned to its original height, so that the puncture device 12 does not protrude from the tip 1 la of the biosensor chip 11! / It ’s in a state!

In this way, do not protrude from the tip 1 la of the biosensor chip 11! The used biosensor cartridge 10 that is not damaged by the user with the puncture device 12 can be properly processed.

For puncturing, in addition to puncturing by pressing the biosensor cartridge 10 against the subject M, for example, a drive mechanism may be used. 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.

[0046] In consideration of the blood collection burden of the subject M, the volume of the hollow reaction part 15 is preferably 1 L (microliter) or less, particularly preferably 300 nL (nanoliter) or less. With such a small hollow reaction part 15, a sufficient blood volume of the subject can be collected even if the diameter of the puncture device 12 is small. Preferably, the diameter is 1000 m or less.

[0047] As described above, according to the biosensor cartridge 10 and the biosensor device 30 described above, when the microsensor chip 11 and the puncture device support 28 are pressed against the subject M, the elastic body 20 is compressed. As a result, the tip 12a of the puncture device 12 protrudes and can puncture the subject M. 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. The spilled blood D is guided through the through hole 22 and the puncture device 12 to the sample collection port 13 formed in the inclined portion l ib of the biosensor chip 11, so that the minute puncture port A small amount of blood D can be collected effectively, and the pain of 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, the burden on the subject M can be reduced.

[0048] Further, 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. Further, when the puncture device 12 does not protrude from the distal end surface 21 of the elastic body 20 when it is discarded after use, it can be disposed of safely and properly.

[0049] In addition, since puncture and sample collection can be performed by a series of operations, it is possible to easily and reliably perform the sample without the need to align the sample collection port 13 of the biosensor chip with the puncture port as in the prior art. Can be collected. In addition, blood D information is transmitted to the measuring device 31 via the detection electrodes 18a and 18b, so that it can be measured in a short time and easily. Therefore, the burden on the subject M can be reduced.

[0050] 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 force in which the inclined angle portion l ib of the negative sensor chip 11 is inclined by approximately 45 degrees is not limited to this, and can be set to an appropriate angle. .

Further, even if the angle is not provided, the sample collection port may be provided only at the corner of the tip. In addition, the hollow reaction part 15 has a rectangular shape inclined approximately 45 degrees, and its inclination angle and shape can be changed as appropriate. In the above-described embodiment, the force S illustrated as an example in which the hollow reaction portion 15 of the biosensor chip 11 is provided in the spacer layer 17 sandwiched between the substrates 16a and 16b, the biosensor of the present invention. The sensor cartridge is not limited to this.

[0051] Further, in the above-described embodiment, the force described in the case where the blood D is collected by the surface tension or capillary phenomenon. For the application of the present invention, a device such as a pump for sucking the blood D flowing out to the puncture port is used. Can be used. Further, it goes without saying that the detection electrodes 18a and 18b can be configured in a straight line shape as required in the L shape or in a shape as required.

In addition, although an elastic body is provided in the above embodiment, the present invention may have a configuration in which this elastic body is not provided.

[0052] 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. This application is based on a Japanese patent application filed on November 21, 2006 (Japanese Patent Application No. 2006-314188), the contents of which are incorporated herein by reference.

Industrial applicability

[0053] As described above, the biosensor cartridge according to the present invention opens in the direction intersecting the axis of the tip of the sample-collecting mouth force puncture device provided at one end of the biosensor chip. Therefore, since the sample collection port can move the sample collection port closer to the puncture port formed by the tip of the puncture device than before, even a small amount of sample can be collected easily by the sample collection port. And a reliable inspection can be performed. In addition, according to the present invention, Then, it is possible to provide a biosensor device that can perform a reliable test.

Claims

The scope of the claims

[1] A biosensor cartridge having a biosensor chip having a sample collection port for collecting a sample at a tip and a puncture device fixed to the biosensor chip, wherein the sample collection port is the puncture device A biosensor cartridge characterized by opening in a direction intersecting with the axis of.

[2] The biosensor cartridge according to [1], wherein the sampling port is provided at a corner of the tip of the biosensor chip! /.

[3] The puncture device support that holds the puncture device is integrated with the biosensor chip so as to sandwich the biosensor chip from the front and back sides thereof. The biosensor cartridge according to 1 or 2.

[4] The biosensor chip and the tip of the puncture device support are provided with an elastic body that includes a puncture port formed in the subject by the puncture device and forms a space necessary for sampling. The biosensor cartridge according to claim 1, wherein the force is any one of claims 1 to 3.

5. The biosensor force trough according to claim 4, wherein at least a tip surface of the elastic body has adhesiveness.

[6] The power according to any one of claims 1 to 5, comprising the biosensor cartridge according to 1, and a measuring device that obtains information on a sample collected by connecting to a detection electrode of the biosensor cartridge. A biosensor device characterized by the above.