KR20080110356A - Bio-sensor - Google Patents

Abstract

A biosensor for detecting the analyte in a sample is provided to prevent the generation of errors in the lead of the identification information recording tool in advance due to pollution of the identification information recording tool by introducing the blood flow prevention part. The biosensor(100) measures the analyte existing in the sample and comprises: the lower plate(110); spacer(120) which sticks the lower plate to the predetermined upper plate and forms the sampling import space which induces the sample to be inhaled to the position of the measurement electrode along the reactive layer(51) of the lower plate; and the upper plate(130) which is adhered to face the lower plate through the spacer, and forms the reactive layer reacting with the analyte existing in the sample on the measurement electrode, wherein the sample flow prevention part(131) is formed in at least a portion of the upper plate or the lower plate.

Description

Bio-sensor

1 is an exploded perspective view of a biosensor according to an embodiment of the present invention;

2 is an exploded perspective view of a biosensor according to another embodiment of the present invention;

3 is an embodiment in which the biosensor according to the present invention is mounted on a meter;

Figure 4 is a bottom view of the lower substrate of the biosensor according to an embodiment of the present invention.

<Brief Description of Drawings>

30: lead part

31: lead wire 32: lead terminal

41: reference electrode 42: working electrode

50: insulating film 51: reaction layer

100: biosensor

110: lower substrate

120: spacer

130: upper substrate

131: sample flow prevention unit

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a biosensor, and more particularly, to a technique capable of preventing a sample from flowing into a portion other than a portion to be injected (for example, a reaction layer) when a sample (for example, blood or a test solution) is injected.

The biosensor forms an electrode system including a plurality of electrodes on the substrate by screen printing or the like, and a reaction layer formed of a hydrophilic polymer, a redox enzyme, and an electron acceptor is formed on the formed electrode system. Such a biosensor is a disposable sensor used to measure blood glucose or cholesterol content in blood samples taken from a human body. In general, a biosensor measuring analyte in a sample electrochemically includes a working electrode and a reference electrode. For example, the measuring principle of the electrochemical sensor using Oxidoreductase and an electron transfer mediator is shown below.

[Scheme]

Analyte + Enzyme (Reduced State) + Electron Transfer Mediator (oxidized state) ===> Reaction Result + Enzyme (oxidized State) + Electron Transfer Mediator (reduced state)

In this scheme, the reduced electron transfer mediator produced by reacting with the analyte in the sample is proportional to the concentration of the analyte present in the sample.

On the other hand, the portable measuring device (hereinafter referred to as 'meter') is a reduced state by applying a constant voltage to the working electrode based on the reference electrode of the biosensor when the biosensor is mounted in the sensor insert The electron transfer mediators are oxidized and the analyte in the sample can be quantified by measuring the amount of oxidation current.

However, when a sample (for example, blood or a test solution) is injected into a conventional biosensor, the sample flows to a portion other than a portion to be injected (for example, a reaction layer), and thus, the biosensor inlet of the meter is contaminated by the sample. there was. Furthermore, in the case of the meter without the ejector, the user must remove the used biosensors directly.

Accordingly, the present invention is to provide a biosensor that prevents the sample from flowing out of the biosensor to solve the above problems.

Another object of the present invention is to provide a biosensor capable of increasing the sample suction rate to a portion (eg, a reaction layer) to which a sample is to be injected while preventing a sample flow out of the biosensor.

According to an aspect of the present invention, a biosensor includes a lower substrate, a lower substrate, and a predetermined upper substrate on which a measurement electrode and a reaction layer reacting with an analyte present in a sample are formed on the measurement electrode. And a spacer on which a sample introduction space is formed to bond and induce a sample to be sucked to the position of the measurement electrode along the reaction layer of the lower substrate, and an upper substrate bonded to face the lower substrate through the spacer. Sample flow prevention portion is formed on at least a portion of the.

According to this aspect, the biosensor of the present invention can prevent the sample from flowing to a portion other than a portion (eg, a reaction layer) to be injected when the sample is injected into the upper substrate or the lower substrate. In addition, when the biosensor of the present invention is inserted into the meter, it is possible to prevent the meter from being contaminated by the sample.

The biosensor according to another aspect of the present invention, the upper substrate is further formed with an air discharge space for discharging the air sucked with the sample through the sample introduction space formed in the spacer, the air discharge space is constant with the sample flow prevention unit Characterized in that formed to be spaced apart by a distance.

According to this aspect, the biosensor of the present invention can increase the sample suction rate to a portion (eg, reaction layer) to which the sample is to be injected while preventing the sample flow to the outside during sample injection.

Hereinafter, with reference to the accompanying drawings will be described a preferred embodiment of the present invention; In the following description of the present invention, if it is determined that detailed descriptions of related well-known functions or configurations may unnecessarily obscure the subject matter of the present invention, the detailed description thereof will be omitted. In addition, terms to be described below are terms defined in consideration of functions in the present invention, which may vary according to intention or custom of a user or an operator. Therefore, the definition should be made based on the contents throughout the specification.

1 is an exploded perspective view of a biosensor according to an embodiment of the present invention. Referring to FIG. 1, the biosensor 100 according to the present exemplary embodiment includes a lower substrate 110, a spacer 120, and an upper substrate 130.

The upper substrate 130 is bonded to face the lower substrate 110 through the spacer 120. As shown in FIG. 1, the sample flow preventing part 131 is formed on the upper substrate 130. The sample flow prevention part 131 includes a hydrophobic material that may interfere with the course of the hydrophilic sample. Accordingly, when the sample is injected into the biosensor, the sample may be prevented from flowing along the upper substrate 130. The sample flow prevention part 131 may be formed by a screen printing method on the upper substrate 130 using an adhesive material having no conductivity. Sample flow prevention portion 131 may be implemented to be formed on the entire upper substrate 130, it may be implemented to be formed on a portion.

The lower substrate 110 may be a material having a thickness of 50 ~ 400um. The lower substrate 110 has a lead portion 30 including a lead terminal 32 and lead wires 31 extending from each lead terminal 32 at one end thereof. In addition, the lower substrate 110 includes electrodes 41 and 42 connected to the lead wire 31. In one example, the electrodes 41 and 42 can be fabricated using carbon, graphite, platinum treated carbon, silver, gold, palladium or platinum components. For example, the electrode may be printed on the lower substrate 110 using an ink composed of carbon, platinum treated carbon, or an ink containing palladium. Reference numeral 50 is an insulating film for electrical insulation of the electrodes 41 and 42.

The reaction layer 51 is a layer for inhaling a sample and causing a reaction. The reaction layer 51 is an electrode that reacts with an analyte in the sample, an electron transfer mediator that reacts with the enzyme, and a buffer solution, an enzyme stabilizer, and other components thereof. It consists of a polymer support fixed on the top. The reaction layer 51 is applied and fixed on the electrodes 41 and 42.

Here, enzymes include various kinds of oxidoreductases such as glucose oxidase, lactate oxidase, cholesterol oxidase, alcohol oxidase, glucose dehydrogenase, GOT (glutamate oxaloac PET trnasmianse) and GPT (glutamate pyruvate trnasmianse). Transferase and hydrolase may be used. In addition, as the electron transfer mediators, for example, hexaamineruthenium chloride, ferrocene and its derivatives, quinones and their derivatives can be used to react or oxidize or reduce the enzyme. have.

When the sample including the analyte is injected into the reaction layer 51, the reaction layer 51 is dissolved by the sample, and the analyte and the enzyme (Enzyme) in the sample react to oxidize the analyte. Is reduced. Analyte contained in the sample by measuring the oxidation current obtained by electrochemically oxidizing the reduced electron acceptor after the end of the enzymatic reaction through a meter (not shown) in contact with the lead wire 32 connected to the electrodes 41 and 42. The concentration of can be obtained.

The spacer 120 forms a capillary tube through the sample introduction space 121 formed by adhering the upper substrate 130 and the lower substrate 110. The thickness of the spacer 120 should be at least equal to or thicker than the thickness of the reaction layer 51. The reason for this is that the sample makes it easier to inject the sample into the reaction layer 51. That is, when the thickness of the spacer 120 is larger than the thickness of the reaction layer 51, sample injection into the free space becomes easy. Spacer 120 is composed of a double-sided tape and may be a double-sided tape having a thickness of 10 ~ 300um. In particular, in order to minimize the amount of sample to be injected, the thickness of the double-sided tape is preferably 10 ~ 150um. The sample injection space 121 formed in the spacer 120 is formed to gradually narrow the shape of the end portion as shown in FIG. 1 in order to prevent the blood from spreading at the end portion that meets the air discharge space 132. It is preferable.

According to an additional characteristic aspect of the present invention, the upper substrate 130 has an air discharge space 132 and a transparent window for discharging air sucked with the sample through the sample introduction space 121 formed in the spacer 120. 134 is further formed. The air discharge space 132 may be formed to be spaced apart from the sample flow preventing part 131 by a predetermined distance. The transparent window 134 is formed on a portion of the upper substrate 130 corresponding to the enzyme reaction layer 51 so that a user can confirm that a sample (for example, blood) is injected into the enzyme reaction layer 51 by a capillary phenomenon. It is preferable.

According to this embodiment, the sample to be measured through the sample introduction space 121 is automatically injected into the capillary phenomenon, the air existing in the sample introduction space 121 is formed on the upper substrate 130 due to the inflow of the sample It is discharged to the outside through the air discharge space (132). Accordingly, the biosensor 100 of the present invention can increase the sample suction rate to the portion to which the sample is to be injected, for example, the reaction layer 51 while preventing the sample flow to the outside of the biosensor. In addition, the air discharge space 132 is formed to be spaced apart from the sample flow preventing portion 131 by a predetermined distance, it can block the injection of the sample into the air discharge space (132).

On the other hand, the upper substrate 130 may be further provided with a sample injection groove 133 at the sample inlet entry position of the upper substrate 130 to facilitate sample injection. In this case, the reaction layer 51 may be contaminated by the sample injection groove 133, but when the size of the sample injection groove 133 is very small, the degree of contamination may be minimized.

2 is an exploded perspective view of a biosensor according to another embodiment of the present invention. Referring to FIG. 2, the biosensor 200 according to the present exemplary embodiment includes a lower substrate 210, a spacer 220, and an upper substrate 230. Here, the structure of the lower substrate 210 shown in FIG. 2 is the same as that of FIG.

The spacer 220 forms a capillary tube through the sample introduction space 221 formed by adhering the upper substrate 230 and the lower substrate 210. As shown in FIG. 2, the sample injection space 221 is preferably formed to gradually narrow the end of the sample injection space 221 in order to prevent the blood from spreading at the end that meets the air discharge space 232. .

The upper substrate 230 is bonded to face the lower substrate 210 through the spacer 220. As shown in FIG. 2, the sample flow preventing part 231 is formed on the upper substrate 230. The sample flow prevention part 231 includes a hydrophobic material that may interfere with the course of the hydrophilic sample. Accordingly, when the sample is injected into the biosensor, the sample may be prevented from flowing along the upper substrate 230. The sample flow prevention part 231 may be formed by a screen printing method on the upper substrate 230 with an adhesive material having no conductivity.

As the sample is injected through the sample introduction space 221, the upper substrate 230 may have an air discharge space 232 in which the air is discharged, in a tunnel shape perpendicular to the sample injection direction. Preferably, to prevent the spreading of the blood by capillary action and to increase the air discharge rate to improve the sample suction rate, while forming the shape of the air discharge space during the manufacturing process of the biosensor, the air discharge space The width and height of the air discharge space 232 should be embodied so as not to be pressed or distorted even after the formation.

Therefore, according to the experimentally obtained results, in the biosensor according to the present invention, it is preferable that the cross section of the air discharge space 232 has a width of about 0.3 mm to 3 mm and a height of about 0.1 mm to 3 mm. In this case, the sample injected through the sample introduction space is particularly preferably about 1 μl or less.

On the other hand, the upper substrate 230 may be further provided with a sample injection groove 233 and the transparent window 234 at the sample inlet entry position of the upper substrate 230 to facilitate sample injection. In this case, the reaction layer 51 may be contaminated by the sample injection groove 233, but if the size of the sample injection groove 233 is very small, the degree of contamination may be minimized. The transparent window 234 is formed on a portion of the upper substrate 230 corresponding to the enzyme reaction layer 51 so that a user can confirm that a sample (for example, blood) is injected into the enzyme reaction layer 51 by a capillary phenomenon. It is preferable.

3 is an embodiment in which the biosensor according to the present invention is mounted on a meter. As illustrated, when the biosensor 100 according to the present invention is mounted on the meter 300, the sample injected into the biosensor 100 may not flow below at least the dotted line A. This prevents the meter 300 from being contaminated by the sample. Furthermore, in the case of the meter 300 without the ejector, the user must directly remove the used biosensor, and in this case, the user may be able to solve the problem of depositing the sample on the user's hand.

Figure 4 is a bottom view of the lower substrate of the biosensor according to an embodiment of the present invention.

As shown, the lower substrate 400 of the biosensor according to the present invention may be formed with an identification information recording means 420 for recording the sample flow prevention unit 410 and the identification information of the biosensor. Preferably, the identification information recording means 320 is formed to be spaced apart from the sample flow prevention part 410 by a predetermined distance.

Here, the identification information refers to detailed information on the biosensor referenced by the user as needed, such as a manufacturer of the biosensor, a calibration code for correcting a measurement result, a serial number, and the like. The calibration code for calibrating the measurement result is a code value referred to to calibrate it in the measuring device because the test results are different when the performance test of each manufactured biosensor under the same conditions.

Identification information of the biosensor can be implemented to be recorded in various ways as follows. First, the identification information of the biosensor may be recorded by using the color included in the color tag. For example, if the color included in the color tag is red, it is a biosensor for measuring blood glucose of company A, and if it is yellow, the color tag is implemented to indicate that it is a biosensor for measuring hemoglobin of company B. The identification information of the biosensor may be recorded and read according to the included color.

Second, the identification information of the biosensor may be recorded by the chroma of the color included in the color tag. For example, if the color included in the color tag is red and the chroma is above a certain threshold, it is A's blood glucose measurement biosensor, and if the chroma is below a specific threshold, hemoglobin of A It indicates that it is a measurement biosensor, and if the color included in the color tag is yellow and the chroma is above a certain threshold, it is B company's blood glucose measurement biosensor, and the chroma is a specific threshold If it is less than, by implementing to indicate that the B hemoglobin measurement biosensor can be recorded by the identification information of the biosensor by the chroma (Color) included in the color tag (Color), it can be read.

Third, the identification information of the biosensor may be recorded by an array pattern of different colors included in the color tag. For example, the color tag region is divided into a first region and a second region, and when the color of the first region is red, it is a biosensor manufactured by company A, and in the case of yellow, company B It indicates that it is a biosensor manufactured by, and if the color of the second area is red, the biosensor for blood glucose measurement is implemented, and in the case of yellow, the biosensor is included in the color tag. The identification information of the biosensor can be recorded and read by the arrangement of different colors.

As described above, the biosensor of the present invention can prevent the sample from flowing into portions other than the portion to be injected (for example, the reaction layer) when the sample is injected into the upper substrate or the lower substrate. In addition, even if the biosensor of the present invention is inserted into the meter, there is a useful effect to prevent the meter from being contaminated by the sample.

In addition, the biosensor of the present invention by forming a three-dimensional air discharge space on the upper substrate in the direction as perpendicular to the sample injection direction, it is possible to improve the sample suction rate by effectively discharge the air to the outside during sample intake It has a useful effect.

In addition, the biosensor according to the present invention has a useful effect of preventing an error from occurring when the identification information recording means is read due to contamination of the identification information recording means by introducing a blood flow prevention unit.

Although the present invention has been described with reference to the accompanying drawings, it will be apparent to those skilled in the art that many various obvious modifications are possible without departing from the scope of the invention from this description. Therefore, it should be interpreted by the claims described to include many such variations.

Claims (6)

In the biosensor for measuring the analyte present in the sample, A lower substrate having a measurement electrode and a reaction layer formed on the measurement electrode to react with an analyte present in the sample; A spacer for adhering the lower substrate to a predetermined upper substrate and having a sample introduction space for inducing a sample to be sucked to the position of the measurement electrode along the reaction layer of the lower substrate; And An upper substrate is bonded to face the lower substrate through the spacer, Biosensor, characterized in that the sample flow prevention portion formed on at least a portion of the upper substrate or the lower substrate. The biosensor of claim 1, wherein the sample flow prevention part comprises a hydrophobic material. The method of claim 2, Biosensor characterized in that the hydrophobic (Hydrophobic) material is formed by the screen printing method. According to claim 1, The upper substrate further comprises an air discharge space for discharging the air sucked with the sample through the sample introduction space formed in the spacer, The air discharge space is characterized in that the biosensor is formed so as to be spaced apart from the sample flow prevention portion by a predetermined distance. The method of claim 1, wherein the upper substrate or the lower substrate further comprises identification information recording means for recording the identification information of the biosensor, The identification information recording means is formed so as to be spaced apart from the sample flow preventing unit by a predetermined distance. 6. The apparatus of claim 5, wherein said identification information recording means is: And a color tag for recording identification information including at least one of a manufacturer of the biosensor by color and at least one of correction code information for correcting a measurement result.

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