JP2008003066A - Biosensor cartridge - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor cartridge capable of preventing a component in a reagent layer from intruding into a body of a user, when pierced. <P>SOLUTION: A separation material 20 is interposed between the reagent layer 13 and a piercing tool 12 to prevent the reagent layer 13 from contacting directly with the piercing tool 12, in a hollow reaction part 14 provided in a tip 11a of a chip body 11, and the component in the reagent layer is thereby prevented from intruding into the body of the user, when pierced by the piercing tool 12. <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 layer housed in a hollow reaction part of a chip.

Conventionally, for example, a biosensor cartridge that detects the concentration of glucose in blood is known (see, for example, Patent Document 1).
FIG. 6 is an exploded perspective view showing the glucose sensor described in Patent Document 1. As shown in FIG. As shown in FIG. 6, 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. In addition, insulating layers 104 and 104 ′ that also serve as adhesive layers, such as epoxy resin adhesives, silicone adhesives, or glass, are generally applied to the cut surfaces that have been cut into half, and these insulating layers 104 and 104 ′ are applied. The working electrode 102 is attached via The working electrode 102 is a flat plate member on which glucose oxidase enzyme (GOD) is immobilized, and is adhered to the counter electrode 101 with the surface on which GOD is immobilized facing inward.
Accordingly, the tip 103 of the needle-like counter electrode 101 is punctured into the subject to collect blood, 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 cartridge in which a biosensor chip and a lancet are integrated is disclosed (see, for example, Patent Document 2).
FIG. 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 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 lancet 113 can be fixed to the chip body 111 by pressing both sides of the chip body 111 with a finger and pressing the projection 113a of the lancet 113, and puncture is performed in this fixed state. 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).

Therefore, in use, the protective cover 115 is removed, the lancet 113 is pushed, the needle 114 is protruded from the tip body 111, and both sides of the tip body 111 are pressed with fingers to fix the needle 114. 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.
Japanese Patent Laid-Open No. 2-120655 (FIG. 1) WO02-056769 (FIG. 1)

In the glucose sensor 100, which is a biosensor described in Patent Document 1 described above, the entire glucose sensor 100 functions as a puncture device, and an immobilized GOD 105, which is a reagent layer, is directly attached to the inner surface of the puncture device. Therefore, when the immobilized GOD 105 adheres to the tip for some reason, there is a possibility that the component of the immobilized GOD 105 enters the body at the time of puncturing, and improvement has been desired.
Further, when the puncture is performed by moving the needle 114 as in the lancet integrated sensor 110 described in Patent Document 2, the needle 114 is not directly guided when the needle 114 is moved. There was a possibility that the puncture position was shifted due to blurring in the direction.
Furthermore, there has been a problem that the measurement accuracy is lowered due to the influence of the change in the substantial glucose concentration due to the red blood cell component in the blood, the electrode covering effect due to the protein, the impurities causing the oxidation-reduction reaction, and the like.

  A main object of the present invention is to provide a biosensor cartridge that can prevent components of a reagent layer from entering a user's body during puncturing.

  In order to achieve the above-described object, a biosensor cartridge according to the present invention has a chip body and a puncture device provided so as to be able to protrude forward from the tip of the chip body. A biosensor cartridge having a hollow reaction part provided with a reagent layer that reacts with a sample collected by puncturing with the puncturing device, wherein a separating material is provided between the puncturing device and the reagent layer. The puncture device and the reagent layer are separated from each other.

  In the biosensor cartridge configured as described above, in the hollow reaction portion provided at the tip of the chip body, a separating material is provided between the reagent layer and the puncture device so that the reagent layer and the puncture device are directly connected to each other. This prevents contact of the reagent layer components with the puncture device, and ensures that the reagent layer components enter the user's body when puncturing with the puncture device. Can be prevented. In the present invention, a needle, a lancet needle, a cannula and the like are collectively referred to as a puncture device.

  In the biosensor cartridge according to the present invention, it is preferable that a hole for introducing a sample into the hollow reaction part is formed in the separation material.

  In the biosensor cartridge configured as described above, the separating material separates the reagent layer and the puncture device, and the unnecessary holes in the sample are removed by the holes formed in the separating material. Only components necessary for the measurement can be passed, and the measurement accuracy can be improved. For example, when measuring the amount of glucose in the blood, cells such as red blood cells and white blood cells and blood coagulation components do not pass, but the liquid component in serum has a pore size that allows the reaction between the reagent and glucose. Measurement accuracy can be improved. By adjusting the pore size of the separation material, not only cellular components such as erythrocytes but also proteins cannot pass, and the reaction efficiency between the reagent and glucose can be improved. In particular, red blood cells occupy a large proportion in the blood and have a great influence on the measured values. How to reduce the effect of the red blood cells is a problem in the measurement of the blood glucose level sensor. As a result, the measurement accuracy can be greatly improved by eliminating the influence of red blood cells.

  In the biosensor cartridge according to the present invention, it is desirable that the separating material includes the puncture device.

  In the biosensor cartridge configured as described above, since the separating material is included in the puncture device, the puncture device and the reagent layer can be reliably separated, and impurities are removed for measurement. Accuracy can be improved.

  In the biosensor cartridge according to the present invention, it is preferable that the separating material is a guide that supports the puncture device in a movable manner.

  In the biosensor cartridge configured as described above, when puncturing is performed by moving the puncture device relative to the chip body, the separation member guides the puncture device, so that the puncture device is prevented from blurring. , Can be punctured at an accurate position.

  In the blood sugar level sensor cartridge according to the present invention, it is desirable that the sample is blood and the blood sugar level is measured from the collected blood.

  The blood glucose level sensor cartridge configured as described above can be used as a sensor cartridge for blood glucose level measurement, and blood can be collected easily and easily. Further, the blood glucose level of the blood can be accurately and quickly obtained. Can be measured.

  The biosensor device according to the present invention includes the biosensor cartridge according to the present invention and a measuring instrument that obtains information on a sample collected by connecting to a detection electrode of the biosensor cartridge.

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

  According to the present invention, the separating layer is provided between the reagent layer provided in the hollow reaction part provided at the tip of the chip body and the puncture device so that the reagent layer and the puncture device are not in direct contact with each other. Since it did in this way, it can prevent that a reagent layer adheres to a puncture device, and can prevent that the component of a reagent layer penetrate | invades in a user's body at the time of puncture by a puncture device. Is obtained.

DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments according to the present invention will be described in detail with reference to the drawings.
1A is a plan view showing a first embodiment of the biosensor cartridge of the present invention, FIG. 1B is an end view seen from the direction I in FIG. 1A, and FIG. FIG. 3 is a structural view showing an embodiment of the biosensor device of the present invention, and FIG. 4 is a cross-sectional view showing a second embodiment according to the present invention.

  As shown in FIGS. 1 (A) and 1 (B), a biosensor cartridge 10 according to the first embodiment of the present invention includes a chip body 11 and a front side from a tip 11a of the chip body 11 (in FIG. 1 (A)). And a reagent layer 13 that reacts with blood B, which is a sample collected by being punctured by the puncture instrument 12, at the tip 11 a of the chip body 11. And a hollow reaction portion 14. Then, a separating material 20 is provided between the puncture device 12 and the reagent layer 13 to separate the puncture device 12 and the reagent layer 13.

  As shown in FIGS. 1A, 1B, and 2, the chip body 11 includes two substrates 15a and 15b facing each other, and a spacer layer sandwiched between the two substrates 15a and 15b. 16 and is formed in a rectangular shape as a whole. Detection electrodes 17a and 17b are provided on the surface of at least one of the two substrates 15a and 15b, and tip portions (lower ends in FIG. 1A) are provided in parallel at predetermined intervals. It has been. Further, at the rear end portion 11b of the chip body 11, the substrate 17b and the spacer layer 16 are cut so that only the substrate 17a is extended, and the detection electrodes 17a and 17b are exposed on the upper surface of the substrate 17a. Yes.

  As shown in FIG. 1, the hollow reaction portion 14 is formed by the two substrates 15 a and 15 b and the spacer layer 16 from the tip 11 a of the chip body 11 to the portion where the two detection electrodes 17 a and 17 b face each other. ing. A sample collection port 14 a for introducing blood B collected by puncturing a sample with the puncture device 12 into the hollow reaction unit 14 is provided at the tip of the hollow reaction unit 14. That is, the hollow reaction part 14 is formed of the substrates 15a and 15b and the detection electrodes 17a and 17b on both upper and lower surfaces, and a rectangular space is formed with the spacer layer 16 cut into a predetermined shape as a side wall. For this reason, in the hollow reaction part 14, the detection electrodes 17a and 17b are exposed. For example, an enzyme and a mediator are fixed immediately above or in the vicinity of the detection electrodes 17a and 17b in the hollow reaction part 14 in the blood B. A reagent layer 13 that generates an electric current by reacting with glucose is provided. Therefore, the hollow reaction part 14 becomes a part in which, for example, blood B collected and collected from the sample collection port 14 a undergoes a biochemical reaction with the reagent layer 13.

  As shown in FIG. 2, on the outside of the puncture device 12, a cylindrical porous member 21 is provided as an example of the separation material 20 and has a cylindrical shape and a hole into which a sample can be introduced into the hollow reaction portion 14. It has been. And since the circumference | surroundings of the puncture instrument 12 are covered with the cylindrical porous member 21 over the perimeter, between the puncture instrument 12 and the reagent layer 13 can be isolate | separated reliably. The separating material 20 is not limited to a cylindrical shape, and may be a polygonal shape or other shapes. The cylindrical porous member 21 is fixed by both the substrates 15a and 15b and the spacer layer 16, and is provided so as to cover at least the puncture device 12 included in the hollow reaction part 14 from the tip 11a of the chip body 11. Yes. There is a gap 23 between the outer peripheral surface of the puncture device 12 and the inner peripheral surface of the cylindrical porous member 21, and the tip of the gap 23 is a sample collection port 14a. Accordingly, the blood B flowing out from the puncture port punctured by the puncture device 12 is introduced into the gap 23 through the puncture device 12 by its surface tension and capillary phenomenon (see arrow B in FIG. 1A), The cylindrical porous member 21 flows from the inside to the outside (see arrow B in FIG. 2), is introduced into the hollow reaction portion 14, and reacts with the reagent layer 13.

  For this reason, by adjusting the pore diameter of the porous member 21, unnecessary components in the blood B can be removed, and only the components necessary for the measurement can be passed, and the measurement accuracy can be improved. For example, when measuring the amount of glucose in blood B, red blood cells and proteins are not passed, but glucose has a pore size to remove impurities such as red blood cells and proteins to improve measurement accuracy. Can do.

  The cylindrical porous member 21 also functions as a guide member that supports the puncture instrument 12 contained therein in a movable manner. That is, when the puncture device 12 is moved by a driving device (not shown) such as a lancet to puncture the specimen, the cylindrical porous member 21 fixed between the two substrates 15a and 15b is used as a guide. To move inside it. Thereby, blurring of the puncture device 12 can be prevented and puncture can be performed at an accurate position.

Next, the biosensor device according to the present invention will be described. FIG. 3 shows a configuration of a biosensor device 30 using the biosensor cartridge 10 described above.
As shown in FIG. 3, the biosensor device 30 includes the biosensor cartridge 10 described above, and a measuring device 31 that obtains information on blood B collected by connecting to the detection electrodes 17 a and 17 b of the biosensor cartridge 10. have. 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 biosensor device 30 includes a measuring device 31, a power supply 32, a control device 33, a terminal insertion unit 34, a display unit 35, and the like, which are connected to each other. The rear end portion 11b of the chip body 11 of the biosensor cartridge 10 is inserted and fixed to the terminal insertion portion 34, and the detection electrodes 17a and 17b exposed at the rear end portion 11b of the chip body 11 are electrically connected. To be connected to. The biosensor device 30 is small in size, for example, a handy type that a subject can hold with one hand. Therefore, by using this biosensor device 30, analysis and measurement can be performed in a short time simultaneously with puncturing, and the burden on the user can be reduced.

  As described above, in the biosensor cartridge 10 and the biosensor device 30 according to the present invention, the reagent layer 13 and the puncture instrument 12 are separated in the hollow reaction part 14 provided at the tip 11a of the chip body 11. A separator 20 was provided between them. Therefore, the reagent layer 13 and the puncture device 12 can be separated so as not to be in direct contact with each other, and the components of the reagent layer 13 are prevented from entering the body of the user when puncturing with the puncture device 12. can do.

Next, a second embodiment of the biosensor cartridge according to the present invention will be described.
4A is a plan view of the biosensor cartridge according to the second embodiment, and FIG. 4B is an end view of the biosensor cartridge according to the second embodiment as viewed from the direction B in FIG. 4A. . In addition, the same code | symbol is attached | subjected to the site | part which is common in the biosensor cartridge 10 concerning 1st Embodiment mentioned above, and the overlapping description is abbreviate | omitted.

In the biosensor cartridge 10 according to the first embodiment described above, the cylindrical porous member 21 that includes the puncture device 12 and covers the entire circumference is provided as an example of the separating material 20. In the biosensor cartridge 10B, a filter 22 as a film-like porous member is provided as an example of a separating material that separates the reagent layer 13 and the puncture device 12. The filter 22 is preferably provided between the reagent layer 13 and the puncture device 12 over the entire hollow reaction portion 14.
Therefore, also in the biosensor cartridge 10B according to the second embodiment, as in the biosensor cartridge 10 according to the first embodiment described above, the reagent layer 13 and the puncture device 12 can be separated so as not to be in direct contact with each other. Therefore, it is possible to prevent the components of the reagent layer 13 from entering the user's body during puncturing with the puncture device 12.

  Further, by adjusting the pore diameter of the filter 22, unnecessary components in the blood B can be removed, and only the components necessary for the measurement can be passed, and the measurement accuracy can be improved. For example, when measuring the amount of glucose in blood B, red blood cells and proteins are not passed, but glucose has a pore size to remove impurities such as red blood cells and proteins to improve measurement accuracy. Can do.

The biosensor cartridges 10 and 10B of the present invention are not limited to the above-described embodiments, and appropriate modifications and improvements can be made.
For example, in each of the above-described embodiments, the case where the amount of glucose in blood B is measured has been described. However, the present invention can be similarly applied to samples other than blood B.
Further, in each of the above-described embodiments, the detection electrodes 17a and 17b are provided in parallel in the same direction. However, as shown in FIG. 5, the tip ends of the detection electrodes 17a and 17b face each other. It may be bent into an L shape to maintain a predetermined interval. In this case, the same can be applied.

  As described above, the biosensor cartridge according to the present invention is provided with a separating material between the reagent layer provided in the hollow reaction part provided at the tip of the chip body and the puncture device, Since the reagent layer does not come into direct contact with the puncture device, the reagent layer adheres to the puncture device, thereby preventing the components of the reagent layer from entering the body of the user when puncturing with the puncture device. This is useful as a biosensor cartridge or the like for measuring and analyzing chemical substances using a reagent layer housed in a hollow reaction part of a chip.

(A) is a top view which shows 1st Embodiment which concerns on the biosensor cartridge of this invention. (B) is principal part sectional drawing which shows 1st Embodiment which looked at FIG. 1 (A) from the I direction. It is a principal part expanded sectional view of a biosensor cartridge. It is a block diagram which shows embodiment concerning the biosensor apparatus of this invention. It is sectional drawing which shows 2nd Embodiment based on this invention. (A) is a top view which shows another example of the biosensor cartridge of this invention. FIG. 1B is a cross-sectional view of FIG. 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 Chip body 11a Tip 12 Puncture device 13 Reagent layer 14 Hollow reaction part 20 Separation material 21 Cylindrical porous member (porous member, cylindrical member)
22 Filter (porous member)
30 Biosensor device 31 Measuring instrument B Blood (sample)

Claims (6)

A reagent layer that has a chip body and a puncture device that is provided so as to protrude forward from the tip of the chip body, and that reacts with a sample collected by being punctured by the puncture device at the tip of the chip body. A biosensor cartridge having a hollow reaction part provided,
A biosensor cartridge, wherein a separating material is provided between the puncture device and the reagent layer to separate the puncture device and the reagent layer.   The biosensor cartridge according to claim 1, wherein a hole for introducing a sample into the hollow reaction portion is formed in the separation material.   The biosensor cartridge according to claim 1 or 2, wherein the separating member includes the puncture device.   The biosensor cartridge according to claim 3, wherein the separating member is a guide that movably supports the puncture device.   The blood glucose level sensor cartridge according to any one of claims 1 to 4, wherein the sample is blood, and blood glucose level is measured from the collected blood.   A biosensor device comprising: the biosensor cartridge according to any one of claims 1 to 5; and a measuring device that obtains information on a sample collected by connecting to a detection electrode of the biosensor cartridge.

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