TWM567370U - Biological test strip structure - Google Patents

Abstract

The present invention provides a biological test piece structure comprising a substrate, a circuit board, a septum, an enzyme layer and a protective film. The substrate is a rectangular sheet having a flat surface; the circuit board is printed on the substrate and has a working electrode and a reference electrode; the intermediate layer covers the substrate and the circuit board, and the intermediate layer has a gap, so that the working electrode and the reference electrode are exposed. a compartment; an enzyme layer covering the gap of the intermediate layer, the enzyme layer biochemically reacting or chemically reacting with glucose in the sample; and a protective film covering the intermediate layer, and a vent hole is formed in the protective film. The biological test piece structure of the present invention utilizes capillary phenomenon to inhale the sample to accelerate the action time, thereby avoiding the problem of incorrect blood glucose measurement.

Description

Biological test piece structure

This creation relates to a biological test piece structure, and more particularly to a biological test piece structure in which a sample is inhaled by capillary action and is easily taken.

With the advancement of science and technology, the tests that were previously performed in the hospital can now be carried out at home. Currently, the test strips that are commercially available for home operation are mostly disposable test pieces, which can be discarded after the user has used them once. Suitable for non-professionals and home care, no pollution.

The sensing test piece currently used has an electrically insulating substrate, a conductive film, a reactive film layer, and a cover plate, and a conductive film is formed on the electrically insulating substrate, the conductive film comprising at least two separated and non-contacting The anode portion and the cathode portion are partially covered with an electrically insulating layer on the conductive film, and one end of the exposed portion forms a working electrode and a reference electrode, and the other end is connected to the electronic measuring device, and the working electrode and the working electrode The reference electrode is covered with a reaction film layer, and a cover plate is covered on the reaction film layer, and the cover plate has a sample suction groove.

When the sample is dropped into the sample suction tank, the sample reacts with the reaction film layer material, and the potential, resistance or current of the electrochemical reaction changes, and the working electrode which can be contacted by the conductive film and the reaction film layer The reference electrode is conducted to the cathode connector and the anode connector at the other end of the conductive layer, and is connected and receives a signal via an electronic measuring device.

There are many types of blood glucose test strips used in the market today. The structure of the meter is also different. The functions of the existing blood glucose test strips, the types of test strips, and the types of reaction enzymes are all different. Therefore, the blood glucose tester must adjust the calculation parameters for different blood glucose test pieces.

However, the existing blood glucose test piece is a rectangular thin plate body, and the reaction zone and the reaction film layer are both disposed on the narrow side surface of the rectangular piece body, and the test piece must be retained in order to keep the user's finger with a pinching space. A certain width will increase the cost of materials. In addition, the conventional blood glucose test piece receives the sample by dropping, but the sample is dripped from the upper sample into the tank to reach the time of completely filling the entire reaction film layer, which is not favorable for the measurement of the biochemical reaction.

How to solve the above problems, in order to reduce the manufacturing cost of the blood glucose test piece, and speed up the action time of the sample to avoid the problem of incorrect blood glucose measurement, is the subject of research in the technical field.

In view of this, the creator has invested a lot of research and development energy and spirit, constantly making breakthroughs and innovations in this field, and hopes to solve the shortcomings of the use of novel technology, in addition to bringing more good products to the society, and promoting industrial development.

The main purpose of the present invention is to provide a biological test piece structure having a first angle and a second angle, which can reduce the manufacturing cost of the test piece, and absorb the sample by capillary action to accelerate the action time, and the user can easily operate in the hand, and then Achieve accurate detection of blood sugar levels. Therefore, the user can immediately know the blood sugar level through the biological test piece structure and the test of the blood glucose meter, thereby controlling the diet and maintaining the blood sugar concentration.

In order to achieve the above object, the present invention provides a biological test piece structure, which can comprise a substrate, a circuit board, a middle layer, an enzyme layer and a protective film. First, the substrate can be a rectangular sheet, and the rectangular sheet can have a flat surface. And the substrate can have a suction side of the sample. Next, the circuit board can be printed on the substrate, and has a working electrode and a reference electrode. One end of the working electrode can be extended to form a first joint, and one end of the reference electrode can be extended to form a second joint. The electrode and the reference electrode respectively have an L shape, and the first joint forms a fork-shaped electrode structure in which three finger electrodes are connected. Then, the intermediate layer can cover the substrate and the circuit board, and the first joint and the second joint can be exposed to connect a blood glucose meter, and the intermediate layer can have a gap, so that the working electrode and the working electrode The reference electrode exposes the intermediate barrier layer. Furthermore, the enzyme layer may cover the gap of the intermediate layer, and the working electrode of the circuit board may be in contact with the reference electrode, and the enzyme layer may contain a biologically active substance, a non-bioactive substance, and a An enzyme cofactor, a stabilizer, a capillary permeation enhancer and a buffer. The enzyme layer generates a biochemical reaction or a chemical reaction with a glucose in a sample, and the enzyme layer can be used to carry out a reaction of the capillary moisture permeation layer. In addition, the protective film may be covered on the intermediate layer, and a venting hole may be formed in the protective film, the venting hole is disposed adjacent to the enzyme layer; wherein the protective film is used to protect the gasket to avoid It is contaminated and the venting holes can be used for ventilation.

In the biological test piece structure of the present invention, the working electrode and the reference electrode are parallel to each other, and the first joint of the working electrode and the second joint of the reference electrode may extend to a bottom end of the substrate.

In the biological test piece structure of the present invention, the adjacent sides of the suction side of the sample may be a first side and a second side, respectively, and the sample suction side and the first side may form a first angle θ1, The sample suction side and the second side may form a second angle θ2; and the angle of the first angle is equal to the angle of the second angle. The first angle θ1 and the second angle θ2 may be between 100 degrees and 140 degrees, preferably between 110 degrees and 130 degrees, more preferably between 115 degrees and 125 degrees, when the angle of the first angle is The smaller the angle of the second angle, the smaller the area of the substrate required, and the lower the cost.

In the biological test piece structure of the present invention, the protective film may have a U-shaped inner recess corresponding to the sample side of the substrate, and the length and width of the U-shaped inner recess are used to determine the size of the enzyme layer. The sample is drawn from the U-shaped inner notch, which increases the venting and accelerates sample inhalation.

In the biological test piece structure of the present invention, the biologically active substance can be arbitrarily changed according to the user's needs, and the biological active substance can be an enzyme, an antibody or an antigen, and the creation is not limited thereto. Second, the capillary penetration enhancer can be a surfactant.

In the biological test piece structure of the present invention, the stabilizer can be arbitrarily changed according to user requirements, and the stabilizer can be carboxymethyl cellulos (CMC), hydroxymethyl cellulose (HMC). , hydroxypropyl methylcellulose (HPMC), or polyethylene glycol (PEG), the creation is not limited to this.

In the biological test piece structure of the present invention, the material of the substrate can be arbitrarily changed according to user requirements, and the substrate can have good heat resistance, insulation, impact resistance and unintentional fragmentation. The material of the substrate may be polyamide, polyester, polycarbonate, polyethylene terephthalate or polyvinyl chloride. Limited to this.

In the biological test piece structure of the present invention, the material of the working electrode and the reference electrode can be arbitrarily changed according to user requirements, and the material of the working electrode and the reference electrode can have good electrical conductivity, such as gold, silver, palladium. , platinum, carbon. The material of the pair of working electrodes and the reference electrode may be a mixture of one or more of the above materials, and the creation is not limited thereto.

When the user operates the biological test piece structure of the present invention, first, the sample is taken in from the suction side of the sample, and the vent hole can increase the exhaust gas and accelerate the sample suction. In. When the sample is in contact with the enzyme layer, the sample reacts with the enzyme layer to produce an electrochemical change, and the enzyme layer contacts the working electrode and the reference electrode to transport electrochemical changes to the first joint and The second connector enables the blood glucose meter to convert the change in electrochemical changes into a concentration display of the sample, which is easy for the user to interpret.

1‧‧‧Biology test piece structure

10‧‧‧Substrate

101‧‧‧ Sample suction side

102‧‧‧ first side

103‧‧‧ second side

104‧‧‧ bottom

11‧‧‧ boards

111‧‧‧Working electrode

112‧‧‧ reference electrode

113‧‧‧First joint

114‧‧‧Second joint

12‧‧‧ septum

13‧‧‧Enzyme layer

14‧‧‧Protective film

141‧‧‧ venting holes

142‧‧‧U-shaped notch

Θ1‧‧‧ first angle

Θ2‧‧‧second angle

3-3‧‧‧ Extension line

FIG. 1 is a perspective view showing the structure of a biological test piece according to the present embodiment.

Fig. 2 is an exploded view showing the structure of the biological test piece of the present embodiment.

Figure 3 is a side cross-sectional view showing the 3-3 extension line of the biological test piece structure of the present embodiment.

Fig. 4 is a plan view showing the structure of the biological test piece of the present embodiment.

Fig. 5 is a diagram showing the operation of the structure of the biological test piece of the present embodiment.

The embodiments of the present invention are described below by way of specific examples, and those skilled in the art can readily appreciate the other advantages and effects of the present invention from the disclosure herein. In addition, the present invention may be implemented or applied by various other specific embodiments, and various modifications and changes may be made without departing from the spirit of the invention.

1 and FIG. 2, FIG. 1 is a perspective view showing the structure of a biological test piece according to the present embodiment; FIG. 2 is an exploded view showing the structure of the biological test piece of the present embodiment.

As shown in FIG. 1 and FIG. 2, a biological test piece structure 1 of the present invention includes a substrate 10, a circuit board 11, a middle layer 12, an enzyme layer 13, and a protective film 14. First, the substrate 10 is a rectangular sheet body having a flat shape. The surface is flat and the substrate has a sample suction side 101. The circuit board 11 is printed on the substrate 10 and has a working electrode 111 and a reference electrode 112. One end of the working electrode 111 extends to form a first joint 113. One end of the reference electrode 112 extends to form a second joint 114. The working electrode 111 and the reference electrode 112 respectively have an L shape, and the first joint 113 forms a fork-shaped electrode structure in which three finger electrodes are connected. Next, the intermediate layer 12 covers the substrate 10 and the circuit board 11, and exposes the first joint 113 and the second joint 114 to connect a blood glucose meter, and the intermediate layer 12 has a notch 121, so that the The working electrode 111 and the reference electrode 112 expose the intermediate layer 12. Furthermore, the enzyme layer 13 covers the notch 121 of the intermediate layer 12, and the working electrode 111 of the circuit board 11 is in contact with the reference electrode 112. The enzyme layer 13 contains a biologically active substance and a non-biological substance. An active substance, an enzyme cofactor, a stabilizer, a capillary permeation enhancer and a buffer, the enzyme layer 13 generates a biochemical reaction or a chemical reaction with a glucose in a sample. In addition, the protective film 14 covers the intermediate layer 12, and a vent hole 141 is formed in the protective film 14. Wherein, the biological active substance may be an enzyme, an antibody or an antigen; the stabilizer may be carboxymethyl cellulose, hydroxymethyl cellulose, hydroxypropyl methyl cellulose, or polyethanol.

Next, the adjacent sides of the sample suction side 101 are respectively a first side 102 and a second side 103. The sample suction side 101 forms a first angle θ1 with the first side 102, and the sample suction side 101 is The second side 103 forms a second angle θ2, the first angle θ1 is equal to the second angle θ2, and the first angle θ1 and the second angle θ2 may be 110-130 degrees. In addition, the working electrode 111 and the reference electrode 112 are parallel to each other, and the first joint 113 of the working electrode 111 and the second joint 114 of the reference electrode 112 extend to a bottom end 104 of the substrate 10 . Furthermore, the sample suction side 101 of the protective film 14 corresponding to the substrate 10 may have a U-shaped inner recess 142 whose length and width determine the size of the area of the enzyme layer 13. The sample is drawn from the U-shaped inner recess 142 which increases the exhaust and accelerates sample inhalation.

Please refer to FIG. 3, which is a side cross-sectional view of the 3-3 extension line of the biological test piece structure of the present invention.

As shown in Fig. 3, the side cross-sectional view of Fig. 3 is a cross-sectional view taken along the direction of the extension line 3-3 of Fig. 1. The bottom layer is the substrate 10, and the second layer is a circuit board 11 printed on the substrate 10. The circuit board 11 has the working electrode 111 and the reference electrode 112. The third layer is the intermediate layer 12, and The intermediate layer 12 is adjacent to an enzyme layer 13; the uppermost layer is the protective film 14, and the protective film 14 has the vent hole 141.

Please refer to FIG. 4, which is a top view of the structure of the biological test piece of the present embodiment.

As shown in FIG. 4, the length of the protective film 14 is smaller than the length of the substrate 10, so that the first joint 113 and the second joint 114 are exposed. The working electrode 111 can be parallel to the reference electrode 112, and the first joint 113 of the working electrode 111 can extend to the bottom end 104 of the substrate 10 with the second joint 114 of the reference electrode 112. Further, the vent hole 141 is disposed adjacent to the enzyme layer 13, so that the vent hole 141 can increase the exhaust gas and accelerate the sample suction.

Please refer to FIG. 5, which is an operational use diagram of the biological test piece structure of the present embodiment.

As shown in FIG. 5, when the user operates the biological test piece structure 1, the sample is first sucked by the U-shaped inner notch 142, which increases the exhaust gas and accelerates the sample inhalation. When the sample is in contact with the enzyme layer (not shown), the sample reacts with the enzyme layer to produce an electrochemical change, the enzyme layer and the working electrode (not shown) and the reference electrode (not shown) Contacting, the electrochemical change is delivered to the first joint 113 and the second joint 114, so that the blood glucose meter can convert the electrochemical change change into a concentration display of the sample, which is easy for the user to interpret.

However, the above description is only a preferred embodiment of the present invention, and it is not intended to limit the scope of patent protection of the present creation, so the use of the present specification and the content of the schema is used. The equivalent changes are included in the scope of protection of this creation and are combined with Chen Ming.

Claims (10)

A biological test piece structure comprising: a substrate, which is a rectangular piece, the rectangular piece has a flat surface, and the substrate has a sample suction side; a circuit board printed on the substrate and having a working electrode And a reference electrode, one end of the working electrode extends to form a first joint, one end of the reference electrode extends to form a second joint; a middle layer covers the substrate and the circuit board, and the first joint is exposed Connected to the second connector to connect a blood glucose meter, and the intermediate layer has a gap, such that the working electrode and the reference electrode expose the intermediate layer; an enzyme layer covering the gap of the intermediate layer, and The working electrode of the circuit board is in contact with the reference electrode, and the enzyme layer comprises a biologically active substance, a non-biologically active substance, an enzyme cofactor, a stabilizer, a capillary penetration enhancer and a buffer, and the enzyme layer Forming a biochemical reaction or a chemical reaction with a glucose in a sample; and a protective film covering the intermediate layer and opening a venting hole in the protective film. The biological test piece structure according to claim 1, wherein the enzyme layer is used for performing a capillary moisture permeation layer of the reaction. The biological test piece structure of claim 1, wherein the working electrode and the reference electrode are parallel to each other, and the first joint and the second joint extend to a bottom end of the substrate, the working electrode and The reference electrodes respectively have an L-shape, and the first joint forms a fork-shaped electrode structure in which three finger electrodes are connected. The biological test piece structure of claim 1, wherein the adjacent sides of the suction side of the sample are a first side and a second side, and the sample suction side forms a first side with the first side. At an angle, the sample suction side forms a second angle with the second side. The biological test piece structure of claim 4, wherein the angle of the first angle is equal to the angle of the second angle. The biological test piece structure of claim 5, wherein the angle of the first angle and the angle of the second angle are between 100 degrees and 140 degrees. The biological test piece structure according to claim 1, wherein the protective film has a U-shaped inner recess corresponding to the sample suction side of the substrate. The biological test piece structure according to claim 1, wherein the substrate is made of polyamide, polyester, polycarbonate, and polyethylene terephthalate. (polyethylene Terephthalate) or polyvinyl chloride. The biological test piece structure according to claim 1, wherein the biologically active substance is an enzyme, an antibody or an antigen. The biological test piece structure according to claim 1, wherein the stabilizer is carboxymethyl cellulos (CMC), hydroxymethyl cellulose (HMC), hydroxypropyl group Hydroxypropyl methylcellulose (HPMC), or polyethylene glycol (PEG).