JP3184337U - Biosensor specimen - Google Patents

Abstract

The present invention provides a biosensor test piece capable of preventing misuse and reading data accurately.
The biosensor test piece includes a substrate, a work lead, a ground lead, a first spacing layer, a second spacing layer, and an upper lid layer. The substrate 10 includes a reaction region 14. An introduction port 21 is provided on one side surface of the first spacing layer 20. An introduction port 31 is provided on one side surface of the second spacing layer 30. The top lid layer 40 is bonded onto the second spacing layer 30. A specimen introduction groove is formed between the upper lid layer 40, the substrate 10, the introduction port 21 of the first spacing layer 20, and the introduction port 31 of the second spacing layer 30. An exhaust passage 32 is provided at one end of the introduction port 31 of the second spacing layer 30. The biosensor test strip further includes a recognition code lead.
[Selection] Figure 1

Description

The present invention relates to a biosensor test piece, and more particularly to a biosensor test piece whose measurement display device can recognize the type of body fluid.

Clinically, there are many methods for measuring the concentration of biochemical substances in body fluids (blood, etc.). Among them, large-scale biochemical measuring instruments in clinical biochemistry laboratories are widely used. However, since this type of equipment can be used only in a predetermined medical institution, the place where the work is performed is limited. Therefore, as a measurement device for home use, a unit (biosensor) in which a disposable biosensor test strip (strip) is combined with a handy type measurement display device is provided as a measurement device for home use so that it is convenient to carry and can be easily used by individuals. Many are used.

In the reaction region of the biosensor test piece, an electrical signal is acquired by an oxidation or reduction reaction between the enzyme and the specimen sample, and the electrical signal acquired by a measurement display device (such as a blood glucose level measuring device). Is converted into various data such as body fluid concentration. However, since the structure of the conventional biosensor test piece is insufficient or inaccurate in extracting the specimen sample, the result of measuring the specimen sample by the measurement display device is inaccurate or incomplete.

In addition, since the enzyme concentration of the biosensor test piece of each lot is not the same or the use is not the same, a code is placed on the biosensor test piece packaging to classify the types of biosensor test pieces. A number or notation is written. Therefore, when the biosensor test piece is measured, the biosensor test piece cannot be accurately recognized and the body fluid concentration data cannot be accurately measured unless the measurement display device is manually adjusted.

Therefore, the conventional biosensor test piece has been required to be improved.

JP 2008-129004 A

The purpose of the present invention is that the measurement display device (such as a blood glucose level measuring device) can recognize the type of the biosensor test piece and includes a recognition code lead that can prevent misuse of the biosensor test piece. By being able to extract, it is providing the biosensor test piece which a measurement display apparatus can read data correctly.

In order to solve the above-described problem, the biosensor test piece of the present invention includes a substrate, a working lead, a ground lead, a first spacing layer, a second spacing layer, and an upper lid layer.

The substrate includes a reaction region.

The work lead and the ground lead are formed in parallel to the substrate. A measurement contact end is provided at one end of the working lead. The measurement contact end of the working lead is electrically connected to the measurement display device. A first biological reaction end is provided at the other end of the work lead. The first biological reaction end extends into the reaction region. A measurement contact end is provided at one end of the ground lead. The measurement contact end of the ground lead is electrically connected to the measurement display device. A second biological reaction end is provided at the other end of the ground lead. The second biological reaction end extends into the reaction region.

An inlet is provided on one side of the first spacing layer.

An inlet is provided on one side of the second spacing layer. The second spacing layer is coupled above the first spacing layer. The first spacing layer is coupled above the working and ground leads. The introduction port of the first spacing layer and the introduction port of the second spacing layer correspond to the reaction region, so that the first biological reaction end and a part of the second biological reaction end are exposed.

An upper lid layer is bonded onto the second spacing layer. A specimen introduction groove is formed between the upper lid layer, the substrate, the first gap layer inlet, and the second gap layer inlet.

At least one bioreactive membrane is applied to the reaction region.

An exhaust passage is provided at one end of the inlet of the second spacing layer. The exhaust passage communicates with the inlet of the second spacing layer.

The exhaust passage communicates vertically with the inlet of the second spacing layer.

The biosensor test strip further includes at least one sample reaction lead. A measurement contact end is provided at one end of the sample reaction lead. The measurement contact end of the sample reaction lead is electrically connected to the measurement display device. A biological reaction end is provided at the other end of the sample reaction lead. The biological reaction end is covered with the reaction region.

An adhesive layer is further included between the substrate and the first spacing layer. The adhesive layer includes an adhesive. The adhesive layer is a PET adhesive film and is adhered between the substrate and the first spacing layer. An introduction port is provided at a position corresponding to the introduction port of the first spacing layer of the adhesive layer.

The biosensor test strip further includes a recognition code lead. A plurality of measurement contact ends are provided at one end of the recognition code lead. The measurement contact end of the recognition lead code is electrically connected to the measurement display device.

The recognition code lead is two parallel leads.

The identification code lead is two parallel leads, and includes at least one connection point between the parallel leads.

The identification code leads are two parallel leads, and any one of 1-7 connection points is included between the parallel leads.

In the biosensor test piece of the present invention, a biological reaction film is formed by applying an arbitrary test reagent such as an enzyme or a chemical substance to each biological reaction end in the reaction region of the specimen. Thus, a sample sample such as blood or urine fluid is extracted in the reaction region, and data such as concentration is measured by the measurement display device. The biosensor test strip of the present invention is used for measurement of blood sugar, blood lipid, cholesterol, uric acid, hemoglobin, triglyceride, ketone body, creatinine, lactic acid and the like.

The substrate is made of an insulating material, and is configured by mixing one or more materials of the group consisting of polyamide, polyester, polycarbonate, polyethylene terephthalate, and polyvinyl chloride.

The first spacing layer and the second spacing layer are made of an insulating material, and are configured by mixing one or more materials of the group consisting of polyamide, polyester, polycarbonate, polyethylene terephthalate, and polyvinyl chloride. .

The material of the working lead group, ground lead group, and identification code lead group may be one or more materials of the group consisting of gold, silver, palladium, platinum, carbon, biochar, silver paste and silver / silver chloride paste. By being mixed and configured, it has good conductivity.

With the biosensor test strip of the present invention, the measurement display device automatically recognizes the measurement type of the biosensor test strip and the sample, so that the biosensor test strip can sufficiently extract the sample and quickly With this, accurate measurement can be realized.

It is a disassembled perspective view which shows the biosensor test piece by one Embodiment of this invention. It is a see-through | perspective perspective view which shows the biosensor test piece by one Embodiment of this invention. FIG. 5 is an exploded perspective view illustrating a biosensor test piece according to another embodiment of the present invention. It is a see-through | perspective perspective view which shows the biosensor test piece by another embodiment of this invention. It is a top view which shows 1st Embodiment of the work lead and ground lead of this invention. It is a top view which shows 2nd Embodiment of the work lead and ground lead of this invention. It is a top view which shows 3rd Embodiment of the work lead and ground lead of this invention. It is a top view which shows 4th Embodiment of the work lead and ground lead of this invention. It is a top view which shows 1st Embodiment of the sample reaction lead of this invention. It is a top view which shows 2nd Embodiment of the sample reaction lead of this invention. It is a top view which shows 3rd Embodiment of the sample reaction lead of this invention. It is a top view which shows one Embodiment of the recognition code lead of this invention. It is a top view which shows each embodiment of the recognition code lead of this invention.

An embodiment of a biosensor test piece of the present invention will be described in detail with reference to the drawings.

FIG. 1 is an exploded perspective view showing a biosensor test piece according to an embodiment of the present invention. FIG. 2 is a perspective view showing a biosensor test piece according to an embodiment of the present invention. FIG. 3 is an exploded perspective view illustrating a biosensor test piece according to another embodiment of the present invention. FIG. 4 is a perspective view showing a biosensor test piece according to another embodiment of the present invention.

As shown in FIGS. 1 and 2, the biosensor test piece of the present invention includes a substrate 10, a work lead 11, a ground lead 12, a first spacing layer 20, a second spacing layer 30, and an upper lid layer 40.

A reaction region 14 is defined on the substrate 10.

The work lead 11 and the ground lead 12 are formed in parallel to the substrate 10. A measurement contact end 112 is provided at one end of the work lead 11. The measurement contact end 112 is used to electrically connect to the measurement display device. A first biological reaction end 111 is provided at the other end of the work lead 11. The first biological reaction end 111 extends into the reaction region 14. A measurement contact end 122 is provided at one end of the ground lead 12. The measurement contact end 122 is used to electrically connect to the measurement display device. A second biological reaction end 121 is provided at the other end of the ground lead 12. The second biological reaction end 121 extends into the reaction region 14.

An introduction port 21 is provided on one side surface of the first spacing layer 20.

An introduction port 31 is provided on one side surface of the second spacing layer 30. The second spacing layer 30 is coupled above the first spacing layer 20. The first spacing layer 20 is coupled to the upper side of the work lead 11 and the ground lead 12. Since the introduction port 31 and the introduction port 21 correspond to the reaction region 14, a part of the first biological reaction end 111 and the second biological reaction end 121 is exposed.

The top lid layer 40 is bonded onto the second spacing layer 30. As a result, between the upper lid layer 40, the substrate 10, the introduction port 21, and the introduction port 31, the specimen introduction groove 50 is formed by the thickness at which the first spacing layer 20 and the second spacing layer 30 are laminated. It is formed.

When carrying out the measurement, at least one layer of a bioreactive film (enzyme, chemical substance, etc.) is applied to the reaction region 14. The specimen quickly enters the reaction region 14 due to the siphon phenomenon of the specimen introduction groove 50, and the entire first biological reaction end 111, the second biological reaction end 121, and the upper biological reaction membrane due to capillary action. Diffused. Since the biochemical reaction is sufficiently performed, accurate measurement can be performed by observing changes in the current value, resistance value, and the like. As a general embodiment, the potential difference of the specimen sample in the biosensor test piece is read by a measurement display device.

As shown in FIGS. 2 and 4, an exhaust passage 32 is provided at one end of the inlet 31. Since the exhaust passage 32 communicates with the introduction port 31, the specimen sample, which is various body fluids such as blood, enters the specimen introduction groove 50 and the reaction region 14 due to the siphon phenomenon. Since the exhaust passage 32 releases the pressure in the specimen introduction groove 50, the specimen sample that is a fluid is suitably diffused into the reaction region 14 by capillary action.

In the present embodiment, the exhaust passage 32 communicates vertically with the inlet 31 (see FIG. 2). Alternatively, the exhaust passage 32 communicates in parallel with the introduction port 31 (see FIG. 4).

The working lead 11 and the ground lead 12 of the biosensor test piece of the present invention can be designed in various structures so as to be applied to the measurement display device standards of each manufacturer. For example, as shown in FIG. 5, a reaction region 14, a work lead 11, and a ground lead 12 are defined on the substrate 10 of the biosensor test piece. The description of the reaction region 14, the work lead 11, and the ground lead 12 is as described above.

As shown in FIGS. 6 to 8, a reaction region 14, a work lead 11 and a ground lead 12 are defined on the substrate 10 of the biosensor test piece, and at least one empty lead 15 is further defined. The description of the reaction region 14, the work lead 11, and the ground lead 12 is as described above. One end of the empty lead 15 is electrically connected to the measurement display device. With the empty lead 15, the measurement display device can recognize the type of the biosensor test piece.

9 to 11 will be referred to as an embodiment of the present invention. On the biosensor test piece substrate 10, a reaction region 14, a work lead 11 and a ground lead 12 are defined, and a sample reaction lead 13 is further defined. The description of the reaction region 14, the work lead 11, and the ground lead 12 is as described above. A measurement contact end 132 is provided at one end of the sample reaction lead 13. The measurement contact end 132 is electrically connected to the measurement display device. A biological reaction end 131 is provided at the other end of the sample reaction lead 13. The biological reaction end 131 is covered with the reaction region 14. When the amount of the specimen sample is insufficient and a sufficient quantity of the specimen sample cannot be entered into the reaction region 14, the sample reaction lead 13 is placed at one end of the biological reaction end 131 in the reaction region 14 of the specimen sample. The coating contact signal cannot be received. Thereby, when the measurement contact end 132 which is the other end of the sample reaction lead 13 is connected to the measurement display device, it indicates that the sample sample is not sufficiently extracted or cannot be measured. Thereby, it is possible to prevent an electrical signal inaccurately reacting the specimen sample from being transmitted from the sample reaction lead to the measurement display device.

As shown in FIG. 12, the biosensor test strip further includes a recognition code lead 16. The recognition code lead 16 is formed on the surface of the substrate 10 opposite to the work lead 11 and the ground lead 12. A plurality of measurement contact ends 162 are provided at one end of the recognition code lead 16. The measurement contact end 162 is used to electrically connect to the measurement display device.

As shown in FIG. 13, in this embodiment, the recognition code lead 16 has a different recognition code (Code). For example, the code 1 recognition code lead 16 has no connection point between the two leads. The code 2 recognition code lead 16 has one connection point A between the two leads. The code 3 recognition code lead 16 has two connection points A and B between the two leads. The code 4 recognition code lead 16 has three connection points A, B, and C between the two leads. The code 5 identification code lead 16 has four connection points A, B, C, and D between the two leads. The recognition code lead 16 of Code 6 has five connection points A, B, C, D, and E between the two leads. The recognition code lead 16 of Code 7 has six connection points A, B, C, D, E, and F between the two leads. The code 8 identification code lead 16 has seven connection points A, B, C, D, E, F, and G between the two leads.

The biosensor test piece of the present invention has no connection point between two parallel lines of the above-described recognition code lead, or has at least one connection point between two parallel lines, or 2 By having one to seven connection points between two parallel lines, or having any one of a plurality of connection points between two parallel lines, a recognition code is formed.

In the present embodiment, the two leads of the recognition code lead 16 are two parallel lines, and two measurement contact ends 162 are formed at one end. Each measurement contact end 162 is used for electrical connection to a multifunctional measurement display device or the like. Since the measurement display device can automatically recognize the type or function of the biosensor test piece by reading the above-described recognition code lead 16, misuse of the biosensor test piece can be prevented. By applying the recognition code lead 16 to the biosensor test piece of the present invention, when the user inserts the biosensor test piece of the present invention into the measurement display device, the measurement display device is operated by the measurement contact ends of the work lead 11 and the ground lead 12. Since the measurement display device automatically adjusts the reading function according to the measurement type of the inserted biosensor test piece based on the form of the recognition code lead 16, the measurement of the sample is accurately and quickly performed. Can be done.

When using the biosensor test piece of the present invention, first, the sample body fluid to be measured flows from the opening of the specimen introduction groove 50. At this time, since the siphon phenomenon occurs in the specimen introduction groove 50 due to the exhaust passage 32 of the second spacing layer 30, the sample body fluid quickly flows into the specimen introduction groove 50. Next, the specimen introduction groove 50 is directly visually observed by the transparent upper cover layer 40 above the inlet 31 of the second spacing layer 30, and the sample body fluid is allowed to flow into the specimen introduction groove 50 until a sufficient amount is obtained. . At this time, an oxidation-reduction reaction occurs between the sample body fluid in the specimen introduction groove 50 and the reaction region 14 of the substrate 10 to generate an electrical signal.

Thereafter, the biosensor test piece is inserted into the measurement display device, and the measurement display device is activated. Alternatively, the electrical signal automatically activates the measurement display device via the measurement contact end 132 of the sample reaction lead 13 or the measurement contact end 122 of the ground lead 12. The electrical signal is transmitted to the measurement display device via the work lead 11 and the ground lead 12. At the same time, the measurement display device measures the accurate concentration data of the sample body fluid by reading the electronic data of the recognition code lead 16 of the substrate 10, adjusting the measurement type and the standard value, and converting them. Thereby, an accurate measurement result can be promptly provided to the user.

  The detailed description of the present invention according to the above embodiments does not limit the scope of the present invention. Even if a person familiar with the present technology makes changes or adjustments within the scope of the present invention, the important significance of the present invention is not lost and is included in the scope of the present invention.

DESCRIPTION OF SYMBOLS 10 Substrate 11 Work lead 111 First biological reaction end 112 Measurement contact end 12 Ground lead 121 Second biological reaction end 122 Measurement contact end 13 Sample reaction lead 131 Bioreaction end 132 Measurement contact end 14 Reaction region 15 Empty lead 16 Recognition Code lead 162 Measurement contact end 20 First interval layer 21 Inlet port 30 Second interval layer 31 Inlet port 32 Exhaust passage 40 Upper lid layer 50 Sample introduction groove 60 Adhesive layer 61 Inlet port

Claims (10)

A biosensor test strip comprising a substrate, a working lead, a ground lead, a first spacing layer, a second spacing layer, and an upper lid layer,
The substrate has a reaction region;
The working lead and the ground lead are formed in parallel with the substrate, and one end of the working lead is provided with a measurement contact end electrically connected to a measurement display device. A first biological reaction end extending into the reaction region is provided at the other end, and a measurement contact end electrically connected to the measurement display device is provided at one end of the ground lead. A second biological reaction end extending into the reaction region is provided at the other end of the ground lead,
An inlet is provided on one side of the first spacing layer,
An introduction port is provided on one side surface of the second spacing layer, the second spacing layer is coupled above the first spacing layer, and the first spacing layer includes the work leads and The first living body reaction end and the second space layer are coupled to the upper side of the ground lead, and the first space layer introduction port and the second space layer introduction port correspond to the reaction region. A part of the biological reaction end of
The upper lid layer is coupled onto the second gap layer, and the specimen guide is interposed between the upper lid layer, the substrate, the inlet of the first gap layer, and the inlet of the second gap layer. A biosensor test piece, wherein a flow groove is formed. The biosensor test piece according to claim 1, wherein at least one bioreactive film is applied to the reaction region. 2. The biosensor test piece according to claim 1, wherein an exhaust passage communicating with the inlet of the second spacing layer is provided at one end of the inlet of the second spacing layer. The biosensor test piece according to claim 3, wherein the exhaust passage communicates perpendicularly to the inlet of the second spacing layer. The sample reaction lead further includes at least one sample reaction lead, and at one end of the sample reaction lead, a measurement contact end electrically connected to the measurement display device is provided, and at the other end of the sample reaction lead The biosensor test piece according to claim 1, further comprising a biological reaction end that covers the reaction region. An adhesive layer that is a PET adhesive film is further provided between the substrate and the first spacing layer, and the adhesive layer is adhered between the substrate and the first spacing layer. The biosensor test piece according to claim 1, wherein an inlet is provided at a position corresponding to the inlet of the spacing layer. The biorecognition according to claim 1, further comprising a recognition code lead, wherein one end of the recognition code lead is provided with a plurality of measurement contact ends electrically connected to the measurement display device. Sensor specimen. The biosensor test piece according to claim 7, wherein the recognition code lead is two parallel leads. The biosensor test piece according to claim 7, wherein the recognition code lead is two parallel leads, and has at least one connection point between the parallel leads. 8. The biosensor according to claim 7, wherein the recognition code lead is two parallel leads, and any one of 1 to 7 connection points is provided between the parallel leads. Test pieces.

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