JP3117103U - Electrochemical biological specimen that can be sampled in a small amount - Google Patents

Abstract

The present invention relates to a kind of electrochemical biosensor that can be sampled in a trace amount. A pair of insulating substrates is provided, a reaction zone protruding outside is provided on the end face of the substrate, and the reaction zone is opened. Further, a working electrode and a reference electrode having different polarities are provided between the substrates, and the reaction enzyme is applied to one end of the electrode extended to the reaction zone. When detecting, insert the electrode end to which the enzyme is not applied into the measurement instrument. When diffused from all directions and inhaled into the reaction zone, the reactive enzyme dissolves quickly, the electrode becomes a passage by conduction, and the oxidation or reduction substance and the analyte cause a unique reaction, causing the movement of electrons. Let me. Furthermore, the concentration of the specimen can be detected by combining with a detection instrument.
[Selection] Figure 7

Description

  The present invention relates to a kind of electrochemical biological specimen that can be sampled in a small amount. It generates a single electrochemical reaction between an oxidized or reduced substance and a sample to be measured to generate electron transfer, and is used in combination with a detection instrument. Thus, the analyte concentration can be measured. Further, since the circumference of the reaction zone is omnidirectional, the specimen is not restricted in direction and can enter the reaction zone more easily.

The idea of home care is gradually increasing, and there are an increasing number of products that can be self-detected at home, such as blood glucose meters, electronic thermometers, and electronic blood pressure meters that are fast, inexpensive, and do not require special operation. Among them, a disposable blood glucose test piece that can be used in a blood glucose meter measures the blood glucose concentration of a sample to which the principle of electrochemical reaction is applied.
Currently, there are two types of sample collection methods for various blood glucose test strip products on the market, a dropping method and a quantitative method (capillary method). Regarding the design of the test piece, the dropping type is provided with a plastic net on the test piece to cover the reaction zone to prevent contamination.
However, the sample requirement is 3 ml or more. This is extremely inconvenient because elderly people or patients with a long history of diabetes can collect and measure blood samples with a blood collection needle, unless it is a single drop of blood. Often we experience wasting test specimens due to operational errors.

  On the other hand, the required amount of sample in a quantitative (capillary method) test piece is 3 ml or less, and when a small amount of sample comes into contact with the inlet, the sample is automatically inhaled into the reaction zone. However, since the commercially available capillary test pieces are small, inconvenience in use, contamination of the suction port, and there is only one suction port and the direction is fixed, so the operation is extremely inconvenient. . In addition, this type of specimen reduces the electrode area on the reaction zone to achieve a blood requirement of 3 milliliters or less. However, if the electrode area is reduced, the detection signal becomes weaker and a more precise instrument must be used.

  Shown in FIG. 1 is US Pat. No. 5,762,770. It is mainly related to a kind of drop-type sheet-like electrode test piece. One electrode insulating substrate is provided, and an electrode system having two polarities is provided on the same surface. One insulating layer is placed over the electrode system to provide the reaction zone and the positive and negative contacts of the detector. Further, the reaction film is applied to the reaction zone, and a plastic net is put on the upper part of the reaction zone, and then a tape for opening the reaction zone is attached to fix the plastic net.

  However, specimen collection with this type of test piece is a drop method and drops on the reaction area, so there are restrictions on the direction in which the specimen is dropped on the reaction area, and the required amount of specimen is 9 ml or more. is there.

  Shown in FIG. 2 is US Pat. No. 5,120,420. A kind of capillary sheet electrode test piece is mainly used. A specimen loading and reaction zone in which one electrode insulating substrate is provided and the electrode system, electrical insulating layer, reaction film, and hydrophilic top plate on the reaction film are formed on the same end surface as the electrode insulating substrate. Among them, one specimen inlet and gas outlet are provided in the specimen loading and reaction zone. The reaction film is formed by applying a carboxymethyl cellulose (CMC) aqueous solution to the reaction zone of the electrode substrate and drying it to form a hydrophilic polymer CMC layer. Further, a Glucose oxidase solution is applied thereon and dried to form GOD. Then, a hydrophilic polymer-polyvinylpyrrolidone is applied thereon and dried again, and then a protective film (PVP layer) is formed. Further, an organic suspension solution of an electron medium is sprayed thereon to produce a reaction film after drying.

The capillary-type sheet-like electrode test piece has the following problems.
<1> In order to create a reaction film, four processing steps are required: forming a CMC layer, forming a hydrophobic layer on the surface of the reaction zone electrode, forming a GOD layer, a hydrophilic protective film PVP layer and an electron mediator layer. Furthermore, every time a layer is made, it must be dried and the production process procedure is very cumbersome.
<2> After the specimen contacts the electrode tip, it is led to the reaction zone, but there is only one place.
<3> The test piece is too small, causing inconvenience in use and easily contaminating the sample inlet.

FIG. 3 shows Taiwan Patent No. 573735. This involves a kind of blood test piece, which includes the following:
One first substrate, one first electrode, disposed on the first substrate, one end is an electrode contact, and the other end is an electrode enzyme action area.
One insulating layer is provided, covered on the first substrate, and one opening is provided in the electrode enzyme action area.
Apply to one enzyme membrane, electrode enzyme action area of insulating layer opening. A second electrode is provided on the bottom surface of one second substrate, which is placed on the uppermost layer of the blood glucose test piece. One end of the second electrode is an electrode contact, and the other end is an enzyme action area.

  Among them, a narrow slit for acting the capillary effect is provided on the insulating layer of the blood sugar test piece, and an opening is provided at the end of the narrow slit to provide a capillary effect ventilation hole.

  Such a structure solves the above-mentioned problems, but since a certain direction is required for the opening, the area is reduced, and the direction and range of dropping are limited when collecting a specimen.

  Furthermore, since an opening is provided as a vent hole when the capillary effect is applied in the vicinity of a narrow slit, it is more difficult to use and manufacture.

  Shown in FIG. 4 is US Pat. No. 6,258,229 B1. It is mainly related to electrode test pieces that use the capillary effect with the amount of one kind of specimen being 1 milliliter or less, and is provided with one electrical insulating substrate and a three-pole electrode system on the same surface as the substrate. One insulating intermediate layer forms a U-shaped passage and forms an upper cover plate layer having one hole. However, as a drawback, there is only one sample collection port provided at the top of the test piece.

  FIG. 5 shows Taiwan Patent No. 570192. This is related to a kind of thick-film electrode type biotech sensor. A conductive film is provided over the substrate, and a conductive silver liquid and a conductive carbon liquid are provided on the conductive film. The insulating layer exposes part of the conductive film which is placed over the substrate and the conductive film. The plurality of reaction zones are covered with an exposed conductive film on the insulating layer. A plurality of reaction films are placed on the reaction zone, and a reaction film layer and a reaction zone are provided on the washer, and are put on the insulating layer. Furthermore, the upper part of the reaction membrane layer is spaced to inhale the specimen, and the protective membrane is placed on the washer to protect the reaction zone. Further, a ventilation hole is provided on the protective film, and a design for identifying the sample inlet is provided around the ventilation hole.

  However, as a drawback, since the reaction zone is provided at the apex, it is not easy to drop the specimen, and it is difficult to inhale into the reaction zone.

  What is shown in FIG. 6 is US Pat. No. 5,997,817. This is mainly related to a kind of siphon type sheet-shaped electrode test piece. One electrode insulating substrate is provided, and an electrode system is provided on the same surface. One insulating layer is placed over the electrode system to provide the reaction zone and the positive and negative contacts of the detector. Further, the reaction film is applied to the reaction zone, the plastic mesh is put on the upper part of the reaction zone, and a tape for opening the reaction zone is attached to fix the plastic mesh. However, this type of specimen inlet has only one location on the right side. The disadvantage is that there is only one specimen entrance, only one inhalation direction, and only one direction.

  The present invention has developed a kind of electrochemical biosensor that can be sampled in a minute amount in response to the above-mentioned drawbacks of the prior art. A reaction zone is provided on the end face of the test piece, and the reaction zone protrudes from the test piece so that the entire surface is open. As a result, a very small amount of sample is easily inhaled into the reaction zone by the action of capillary diffusion.

  In order to achieve the above object, the present invention provides an electrochemical biological specimen that can be sampled in a small amount. A pair of first and second insulating substrates are provided, and reaction zones are provided so as to protrude from the first and second substrates. The reaction zone is transparent and the entire area around the reaction zone is open. A working electrode and a reference electrode are provided at an appropriate interval between the first substrate and the second substrate. One end of the electrode is extended to the reaction zone, and when the detection is performed, the periphery of the reaction zone is completely open, so that the specimen can be inhaled into the reaction zone without any restriction of direction due to the action of capillary diffusion. For this reason, sample collection is simple, the required amount of sample is kept to 3 ml or less, pain at the time of patient blood collection can be greatly reduced, and the required amount of sample is stable. It can be lost.

  Another object of the present invention is to provide an electrochemical biological specimen that can be sampled in a trace amount. The reaction zone is provided with a hydrophilic reaction membrane, and this hydrophilic reaction membrane is placed on the working electrode and the reference electrode and brought into contact with the specimen, thereby causing a unique electrochemical reaction. Further, the reaction membrane is composed of a hydrophilic polymer and an enzyme, and the specimen can easily enter the reaction zone.

  Yet another object of the present invention is to provide a kind of electrochemical biological specimen that can be sampled in a minute amount. The area around the reaction zone is protruding, making it easy to identify the tactile sensation, providing convenience for inhalation of the sample, and reducing the dose hesitation phenomenon when the sample enters the reaction zone.

In the present invention, at least one of the following effects can be obtained.
<1> Specimen sample collection is simple, the amount of specimen required is less than 3 milliliters, pain at the time of patient blood collection can be greatly reduced, and the amount of specimen required is stable. It can be lost.
<2> The specimen can easily enter the reaction zone.
<3> Convenient for body inhalation, and can reduce the dose hesitation phenomenon when the specimen enters the reaction zone.

  In order to further recognize and understand the object, shape, structure, apparatus, features, and effects of the present invention, the details thereof will be described in conjunction with the following examples and diagrams.

  The present invention relates to a kind of electrochemical biological specimen that can be sampled in a small amount, combining an electrochemical biological detection specimen that is electronically transformed by a unique biochemical reaction between an oxidizing or reducing substance and a specimen with a measuring instrument. When used, specialized analyte concentrations can be sensitively detected.

  7 and 8 show a first substrate and a second substrate 11 and 12 which are placed facing each other on a test piece. The first substrate and the second substrates 11 and 12 are flat and have insulating properties. Furthermore, there is an adhesive around the first substrate and the second substrate 11 and 12 except for both ends (this is one of the implementation methods of the present invention. In other words, the portion where the first substrate and the second substrate 11 and 12 are bonded together without the adhesive has hydrophilicity. Among them, one end of the second substrate 12 covers only a part on the first substrate 11. On the other hand, the other ends of the first substrate and the second substrate 11 and 12 are projected outward to provide the reaction zone 13, the reaction zone 13 is made transparent, and the periphery of the reaction zone 13 is projected. The entire area around the reaction zone 11 is open. This provides convenience for inhalation of the sample and can reduce the hesitation phenomenon during administration when the sample enters the reaction zone (shown in FIG. 8).

  Further, a working electrode 21 and a reference electrode 22 are provided between the substrates 11 and 12, respectively. A fixed gap is provided between the working electrode 21 and the reference electrode 22, one end of the working electrode 21 and the reference electrode 22 extends to the reaction zone 13, and the other end protrudes from the other end of the second substrate 12. The first substrate 11 is short and is placed on the end surface of the first substrate 11.

  In addition, the hydrophilic reaction film 30 is placed on the reaction zone 13, and the hydrophilic reaction film 30 covers the work electrode 21 and the reference electrode 22. In this example, a hydrophilic enzyme is used. A combination of an oxidizing or reducing substance, a hydrophilic polymer, an electron mediator, a surfactant, and a buffer solution. This is brought into contact with the specimen to cause a biochemical reaction.

  The usage state is as shown in FIGS. When detecting, the reaction zone 13 protrudes to the outside of the substrate, and since the entire area around the reaction zone 13 is open, the specimen can be inhaled into the reaction zone 13 by the action of capillary diffusion without being restricted in direction. Furthermore, the specimen is diffused from the hydrophilic reaction membrane 30 and is routed to the reaction zone 13 to cause a biochemical reaction. For this reason, sample collection is simple, the required amount of sample is kept to 3 ml or less, pain at the time of patient blood collection can be greatly reduced, and the required amount of sample is stable. It can be lost.

  As described above, the present invention has novelty in the shape and structure of the article, various defects of the prior art are improved, the effect of use can be improved, and it is practical, so it sufficiently satisfies the requirements of the new patent. This is an ideal idea.

1 is a schematic view of US Pat. No. 5,762,770. 1 is a schematic view of US Pat. No. 5,120,420. It is the schematic of Taiwan patent number 573735. 1 is a schematic view of US Pat. No. 6,258,229B1. It is the schematic of Taiwan patent number 570192. 1 is a schematic diagram of US Pat. No. 5,997,817. It is an exploded schematic diagram of the present invention. It is the combination schematic of this invention. It is a plane perspective view which combined this device. It is the cross-sectional schematic at the time of implementing this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 11 1st board | substrate 12 2nd board | substrate 13 Reaction zone 21 Work electrode 22 Reference electrode 30 Hydrophilic reaction film

Claims (3)

An electrochemical biological test specimen that can be sampled in a trace amount to detect the concentration of a biochemical substance contained in a specimen,
The electrochemical biological specimen is
A pair of electrically insulating first and second substrates;
A reaction zone,
The first substrate and the second substrate are joined to each other at opposite end faces, and a working electrode and a reference electrode are sandwiched between the first substrate and the second substrate,
The reaction zone is formed by projecting an end face where the first substrate and the second substrate are not joined to the outside, and the entire surface is open.
Electrochemical biological specimen that can be sampled in a small amount.
The reaction zone is provided with a hydrophilic reaction membrane, and the hydrophilic reaction membrane is composed of a hydrophilic polymer and an enzyme. 2. The electrochemical biological specimen capable of being sampled in a trace amount according to claim 1, wherein the specimen is configured so that the specimen can easily enter the reaction zone.
The component of the hydrophilic reaction membrane is composed of an oxidative or reductase enzyme, a hydrophilic polymer, an electron mediator, a surfactant, and a buffer salt. Electrochemical biological specimen.

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