JP2008113770A - Biosensor cartridge - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor cartridge which can reduce burden on users by minimizing the amount of a sample drawn necessary for measurement along with an easier drawing of the sample. <P>SOLUTION: The biosensor cartridge has a sample detection part 13, a bent structure part 14 and a joint 12 connected to a measuring apparatus with a sample drawing port for drawing samples. Electrodes installed respectively on the detection part 13 and the joint 12 are conducted through the bent structure part 14 and the connection part is provided with a device for puncturing to draw the sample. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

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

Conventionally, for example, a biosensor chip that detects the concentration of glucose in blood is known (see, for example, Patent Document 1).
FIG. 5 is an exploded perspective view showing the glucose sensor described in Patent Document 1. As shown in FIG. As shown in FIG. 5, 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 a tip 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 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 immobilized, and is adhered to the counter electrode 101 with the surface on which the GOD is immobilized 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 to determine glucose.

In addition, a biosensor in which a biosensor chip and a lancet are integrated is disclosed (see, for example, Patent Document 2).
6A is a perspective view of the sensor described in Patent Document 2, and FIG. 6B is an exploded perspective view of the sensor. As shown in FIG. 6, the lancet-integrated sensor 110 includes a chip body 111, a lancet 113, and a protective cover 115. The chip body 111 has a cover 111a and a substrate 111b that can be opened and closed, and an internal space 112 is formed on the inner surface of the cover 111a. The internal space 112 has a shape capable of movably storing the lancet 113, and the lancet 113 can be exchanged by opening the cover 111a.

  The needle 114 provided at the tip of the lancet 113 can be projected and retracted from an opening 112 a formed at the front end of the internal space 112 of the chip body 111 as the lancet 113 moves. The shape of the internal space 111a 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 locked to the chip body 111 by mutual pressing force and frictional force. It is like that. The protective cover 115 has a tube portion 115 a into which the needle 114 is inserted, 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 prevent the user from being accidentally injured. Note that the substrate 111b is provided with a pair of electrode terminals 116 so that the substrate 111b can be electrically connected to a measuring apparatus (not shown).

In use, the protective cover 115 is removed and the lancet 113 is pushed to cause the needle 114 to protrude from the tip body 111. After puncturing the subject in this state, the needle 114 is housed inside the chip body 111, the opening 112a provided at the front end of the chip body 111 is brought close to the puncture port, and the outflowed blood is collected.
JP-A-2-120655 International Publication No. 02/056769 Pamphlet

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 to each other, the diameter of the puncture needle is approximately the same as the width of the glucose sensor 100 and increases. For this reason, there is a problem in that the amount of blood collected increases, pain during puncture increases, and the burden on the user increases.
The lancet-integrated sensor 110 described in Patent Document 2 has a complicated structure.

  The present invention has been made in view of the above-mentioned problems, and the purpose thereof is to easily collect a sample, reduce the amount of sample necessary for measurement, and reduce the burden on the user. An object of the present invention is to provide a biosensor cartridge that can be used.

  In order to achieve the above-described object, a first feature of the present invention is a biosensor cartridge having a detection unit having a sample collection port for collecting a sample, a bending structure unit, and a connection unit connected to a measuring instrument, A biosensor cartridge characterized in that an electrode provided in each of the detection part and the connection part conducts through the bending structure part, and the connection part is provided with a puncture device for collecting the sample. is there.

In the biosensor cartridge configured as described above, since the connecting portion connected to the measuring device and the detecting portion are connected via the bending structure portion, when the connecting portion is connected to the measuring device, Information on the collected sample can be immediately transmitted to the measuring instrument.
In addition, in the detection unit, when a puncture device is externally attached to the connection part of the biosensor cartridge, if the puncture device is pressed against the subject by holding the connection part, the bending structure part is further bent and is used for puncture. The instrument will be exposed and can be punctured easily. After puncturing, the sample can be easily collected with the same biosensor cartridge by bringing the detection unit closer to the puncture opening.
Further, when the puncture device is pressed against the subject with the connection portion, the bending structure portion is further bent to expose the puncture device, and puncture can be easily performed. After puncturing, the sample can be easily collected with the same biosensor cartridge by bringing the detection unit closer to the puncture opening. Compared with the case where the puncture device is externally attached to the connection portion, the user can easily handle the device. In the state before and after use, by making the tip of the detection unit protrude beyond the tip of the puncture device, the puncture device can be protected, and at the same time, the puncture device may injure the user or the like. Can be prevented.

  A second feature of the present invention is the biosensor cartridge according to the first feature of the present invention, wherein a sample collection port provided in the detection unit for collecting the sample is located in the vicinity of the tip of the puncture device. is there.

  In the biosensor cartridge configured as described above, since the sample collection port is located in the vicinity of the tip of the puncture device, the sample flowing out from the puncture port can be collected immediately and easily and reliably. As a result, measurement can be performed with a small amount of sample, so that the burden on the subject can be reduced.

  The third feature of the present invention is that, in the second feature of the present invention, the detection part is a puncture operation to the specimen by the puncture device, and the sample collection port is not separated from the vicinity of the puncture position by bending. This is a biosensor cartridge.

  In the biosensor cartridge configured as described above, during the puncture operation performed by bending the bent portion, the detection unit is located near the puncture position, so that the sample is collected and inhaled immediately after the puncture. Is possible.

  A fourth feature of the present invention is that in any one of the first to third features of the present invention, the bent structure portion has elasticity.

  In the biosensor cartridge configured as described above, since the bending structure portion has elasticity, even if the puncture device is removed after puncturing, the detection portion extends along the puncture device due to the restoring force of the bending structure portion. The state in contact with the subject can be maintained. For this reason, the sample flowing out from the puncture port can be easily and reliably collected from the sample collection port, and the sample can be prevented from flowing out and soiling clothes and the like.

  According to a fifth feature of the present invention, in any one of the first to fourth features of the present invention, the detection section, the bent structure section, and the connection section are made of PET (polyethylene terephthalate) resin, PBT. (Polybutylene terephthalate) It is formed integrally with a resin selected from the group consisting of a resin, an acrylic resin and a urethane resin.

  In the biosensor cartridge configured as described above, the detection part, the bending structure part, and the connection part are integrally formed of resin, so that the biosensor cartridge can be easily manufactured and the cost can be reduced.

  According to a sixth aspect of the present invention, there is provided a biosensor cartridge according to any one of the first to fifth aspects of the present invention, and a sample collected by connecting to the detection electrode of the biosensor cartridge. A biosensor device having a measuring instrument for obtaining information.

  In the biosensor device configured as described above, a sample is collected by the above-described biosensor cartridge, and information on the sample is transmitted to the measuring device via the detection electrode, so that the measurement can be easily performed in a short time. .

  According to the present invention, since the connecting part connected to the measuring instrument and the detecting part are connected via the bending structure part, when the connecting part is connected to the measuring instrument, information on the sample collected. Can be immediately transmitted to the measuring instrument. In addition, in the detection unit, when a puncture device is externally attached to the connection part of the biosensor cartridge, when the puncture device is pressed against the subject by holding the connection part, the bending structure part is further bent and the puncture device is used. The instrument will be exposed and can be punctured easily. After puncturing, the sample can be easily collected with the same biosensor cartridge by bringing the detection unit closer to the puncture opening.

DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments according to the present invention will be described in detail with reference to the drawings.
1 is a cross-sectional view showing an embodiment of a biosensor cartridge according to the present invention, FIG. 2 is a plan view showing an embodiment of the biosensor system according to the present invention, and FIGS. It is explanatory drawing which shows the operation | movement which uses and measures a blood glucose level.

  As shown in FIG. 1, the biosensor cartridge 10 according to the first embodiment of the present invention includes a connection portion 12 in which a puncture device 11 is fixed to a distal end portion 12 a and a puncture port punctured by the puncture device 11. A sample collection port 17a for collecting the exuded sample has a detection unit 13 provided at the tip 13a. The connection portion 12 and the detection portion 13 are provided so as to be able to approach and separate along the puncture instrument 11 via the bending structure portion 14, and the detection electrode 15 provided on the detection portion 13 is provided on the connection portion 12. It is electrically connected to the electrode 16 provided.

  In the present invention, the puncture device 11 refers to a needle, a lancet, a cannula or the like, and is preferably biodegradable.

  The connecting portion 12 has a rectangular plate shape, and a pair of electrodes 16 and 16 are provided therein. A rear end portion 12b (upper end portion in FIG. 1) of the connecting portion 12 is detachable from a measuring instrument 30 (see FIG. 2) described later, and the electrode 16 can be electrically connected to the measuring instrument 30. ing.

  Bending structure portions 14A and 14B are provided on the left and right sides of the puncture instrument 11 fixed to the front end portion 12a of the connecting portion 12. The bent structure portions 14A and 14B are provided with a plurality of (in this case, for example, three) inclined plates 14a inclined to the left and right outer sides, and are easily deformed when a pressing force acts in the vertical direction in FIG. ing. Thereby, since bending structure part 14A, 14B deform | transforms at the time of puncture with the instrument 11 for puncture, it can puncture easily.

  Further, it is desirable that the bent structure portions 14A and 14B have elasticity, and when the vertical pressing force is removed, the bent structure portions 14A and 14B return to their original shapes by a restoring force. Thus, after puncturing, when the puncture device 11 is extracted from the subject, it can be quickly extracted by the restoring force of the folding structure portions 14A and 14B. Further, when the puncture device 11 is extracted, the bending structures 14 </ b> A and 14 </ b> B extend, so that the detection unit 13 extends along the puncture device 11. In the left and right bent structure portions 14A and 14B, the direction of the inclined plate 14a at each step is preferably the same direction.

  A detection unit 13A is provided at the tip of the bending structure unit 14A. In the detection unit 13, a hollow reaction unit 17 is provided inside one detection unit 13A so that the tip is inclined inward, and the tip of the hollow reaction unit 17 is exposed from the tip 13a of the detection unit 13A. Thus, a sample collection port 17 a for guiding the sample to the hollow reaction unit 17 is formed. The sampling port 17a is desirably provided in the vicinity of the distal end portion 11a of the puncture device 11. Thus, after puncturing, the puncture device 11 can be extracted, and at the same time, the sample flowing out from the puncture port formed by the puncture device 11 can be easily and reliably collected.

  Further, a pair of detection electrodes 15 are provided at a predetermined interval so as to cross the hollow reaction portion 17 and are connected to the electrode 16 of the connection portion 12 via the bending structure portion 14A. A reagent (not shown) that reacts with the sample is provided directly above or in the vicinity of the detection electrode 15 in the hollow reaction portion 17.

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

  In the normal state (the state where the bending structure portion 14 is not compressed and expanded / contracted), it is desirable that the tip of the detection unit 13 protrudes beyond the tip of the puncture device 11. However, in the state where the bending structure portion 14 is compressed, the puncture device 11 is projected. Thereby, the detection part 13 can protect the puncture instrument 11 when not in use. Further, after use, the detecting portion 13 protrudes from the puncture device 11 by the restoring force due to the spring property of the bent structure portion 14, thereby preventing the puncture device 11 from being damaged and medical disposal. Things can be processed safely.

  It is desirable that the connecting portion 12, the bent structure portion 14, and the detecting portion 13 described above are integrally formed of PET resin, RBT resin, acrylic resin, urethane resin, or the like. Thereby, the biosensor cartridge 10 can be easily manufactured, and cost reduction can be achieved.

Next, the biosensor system according to the present invention will be described. FIG. 2 shows a configuration of a biosensor system 30 using the biosensor cartridge 10 described above.
As shown in FIG. 2, the biosensor system 30 includes the biosensor cartridge 10 described above and a measuring device 31 that is connected to the detection electrode 15 of the biosensor cartridge 10 and obtains information on a sample collected. ing. The configuration of the biosensor cartridge 10 is as described above, and the description of the biosensor cartridge 10 described above with reference to FIG.

  The measuring device 31 includes a power supply 32, a control device 33, a terminal insertion unit 34, and a display unit 35, which are connected to each other. The terminal insertion portion 34 is inserted and fixed with the rear end portion 12b of the connection portion 12 of the biosensor cartridge 10, and the electrodes 16 and 16 protruding from the rear end portion 12b of the connection portion 12 are electrically connected. It has become so. The biosensor system 30 is small in size, for example, a handy type that can be held by a person to be inspected with one hand.

Next, with reference to FIGS. 3A to 3C, the usage method will be described by taking as an example a case where a blood glucose level is measured using the biosensor system 30.
First, the rear end portion 12b of the biosensor cartridge 10 main body 12 with the puncture device 11 is inserted into the terminal insertion portion 34 of the measuring device 31 and fixed and electrically connected. The power source 32 of the biosensor system 30 is turned on and it is confirmed whether or not it is normally activated. While holding the biosensor system 30 in one hand, the tip of the detection unit 13 of the biosensor cartridge 10 is brought into contact with a blood collection point of the subject, for example, the finger F (see FIG. 3A), and the folding structure unit 14 is compressed and contracted. The puncture device 11 is punctured (see FIG. 3B).

  When the puncture device 11 is pulled out from the subject, the detection unit 13 is lifted by the restoring force of the bending structure unit 14, so that the tip of the detection unit 13 is pulled out so as not to be separated from the finger (see FIG. 3C). When the puncture device 11 is extracted, blood B, which is a sample, oozes out from the puncture port of the punctured subject, for example, a finger. At this time, the sample collection port 17a provided in the detection unit 13A serves as the puncture device. The blood B that has oozed out can be easily and reliably collected from the sample collection port 17a by the surface tension of the blood B and the capillary action of the hollow reaction portion 17. For this reason, it can measure with a small amount of blood, and the burden on the subject at the time of blood collection can be reduced.

  When a predetermined amount of blood is collected, the biosensor system 30 is released from the finger, and the measurement result is displayed on the display unit 35. The blood B introduced into the hollow reaction portion 17 reacts with the reagent, and the current value or the charge value (charge amount) data measured by the detection electrodes 15 and 15 is sent to the control device 33. A calibration curve data table is stored in the control device 33, and the blood sugar 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 biosensor cartridge 10 is removed from the measuring instrument 31. At this time, the detection unit 13 protrudes from the puncture device 11 due to the restoring force of the bending structure unit 14, so that the biosensor cartridge 10 is not damaged by the puncture device 11. The sensor cartridge 10 can be properly processed.

  In consideration of the blood collection burden of the subject to be examined, the volume of the hollow reaction part is preferably 1 μL (microliter) or less, particularly preferably 300 nL (nanoliter) or less. With such a minute hollow reaction part 14, even if the diameter of the needle 15 is small, a sufficient blood volume of the subject can be collected. Preferably, the diameter is 1000 μm or less.

  As described above, according to the biosensor cartridge 10 and the biosensor system 30 using the biosensor cartridge 10 according to the present invention, blood B as a sample can be collected easily and reliably. For this reason, it can measure with a small amount of blood B, and the burden on the subject can be reduced.

The biosensor cartridge of the present invention is not limited to the above-described embodiment, and appropriate modifications and improvements can be made.
For example, in the embodiment described above with reference to FIG. 1, the case where the bending structure portion 14 is configured by the three-stage inclined plate 14 a is illustrated, but the number of steps and the configuration of the bending structure portion 14 are not limited thereto.
In the above-described embodiment, the detection unit 13A is provided on one side of the puncture device 11, but the detection unit 13A may be provided on the opposite side or on both sides of the needle 11.
Furthermore, the folding structure portion B has better stability when it is present when the detection portion is pressed against the subject during sample collection, but it is also possible to have a structure without the bending structure portion 14B as shown in FIG. It is. Further, the folding structure portions 14A and 14B may be integrated.
Moreover, the blood glucose level measurement shown in the above-described embodiment is an example, and can be used for other measurements.

  As described above, the biosensor cartridge according to the present invention has the connection portion to which the puncture device is fixed and the detection portion are connected via the bending structure portion. By pressing against the person, the bending structure portion is further bent, and the puncture device is exposed so that puncture can be easily performed. Then, after puncturing, by bringing the detection part closer to the puncture opening, there is an effect that a sample can be easily collected by the same biosensor cartridge, and for example, it is accommodated in the hollow reaction part of the chip. It is useful as a biosensor cartridge that measures and analyzes chemical substances using reagents.

It is sectional drawing which shows 1st Embodiment which concerns on the biosensor cartridge of this invention. It is a top view which shows the biosensor system which concerns on this invention. (A)-(C) are explanatory drawings which show the state which measures the blood using the biosensor system concerning this invention. It is sectional drawing which shows another embodiment which concerns on the biosensor cartridge of this invention. It is a disassembled perspective view which shows the conventional biosensor cartridge. (A) is a perspective view which shows the conventional biosensor cartridge. (B) is an exploded perspective view showing a conventional biosensor cartridge.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Biosensor cartridge 11 Puncture instrument 12 Connection part 12a Tip part 13 Detection part 14 Bending structure part 15 Detection electrode 16 Electrode 17a Sample sampling port 30 Biosensor apparatus 31 Measuring instrument B Blood (sample)

Claims (6)

A biosensor cartridge having a detection unit having a sample collection port for collecting a sample, a bending structure unit, and a connection unit connected to a measuring instrument,
The electrodes provided in each of the detection part and the connection part are conducted through the bent structure part,
A biosensor cartridge comprising a puncture device for collecting the sample at the connection portion.   2. The biosensor cartridge according to claim 1, wherein a sample collection port for collecting the sample provided in the detection unit is located in the vicinity of a tip of the puncture device.   The biosensor cartridge according to claim 2, wherein the sample collection port is not separated from the vicinity of the puncture position by bending in the puncture operation to the specimen by the puncture device.   The biosensor cartridge according to claim 1, wherein the bent structure portion has elasticity.   The said detection part, the said bending structure part, and the said connection part are integrally formed by resin chosen from the group which consists of PET resin, PBT resin, an acrylic resin, and a urethane resin. The biosensor cartridge according to any one of the above.   A biosensor comprising: the biosensor cartridge according to any one of claims 1 to 5; and a measuring instrument that obtains information on a sample collected by connecting to a detection electrode of the biosensor cartridge. apparatus.

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