# US 2023/0057549 A1 · Biosensor structure for measuring specimen and method for measuring specimen by using the same

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- Number: US 2023/0057549 A1
- Document ID: US20230057549A1
- Status: Published application
- Kind: A1
- Application number: 17/777,376
- Filed: 2021-09-28
- Published: 2023-02-23
- Earliest claimed: 2020-09-28
- Assignees: Dong Woon Anatech Co., Ltd
- Applicants: Dong Woon Anatech Co., Ltd.
- Inventors: Min Su KWON; Ji Won KYE; Hee Jae WOO; Eun Hyun SHIM; In Su JANG; Dong Cheol KIM
- Web page: https://patentgrep.com/patent/US20230057549A1

## CPC

- C12Q 1/006: {for glucose}
- A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06)
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/15: Devices for taking samples of blood
- A61B 10/00: Instruments for taking body samples for diagnostic purposes (for taking samples of blood A61B5/15); Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- C12Q 1/32: involving dehydrogenase
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- G01N 27/3273: {Devices therefor, e.g. test element readers, circuitry (details not specific to biochemical electrodes G01N33/4875)}
- G01N 33/4875: {Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method (test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B)}
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Disclosed are a biosensor structure for sample measurement and a sample measuring method using same. In a biosensor electrode structure for sample measurement according to an embodiment of the present invention, a working electrode, which is an electrode for measuring a sample, and a reference electrode are arranged to be spaced apart from each other in the longitudinal direction of a sample insertion channel, a working protrusion, which is a protrusion of the working electrode, and two reference protrusions, which are protrusions of the reference electrode, are alternately arranged at a part corresponding to the sample insertion channel, the ratio of the area of the working protrusion to the areas of the reference protrusions is equal to or greater than 1, at least one recognition electrode for recognizing the sample is disposed adjacent to the working electrode or the reference electrode and parallel to the working electrode and the reference electrode while being spaced apart from the working electrode and the reference electrode, and the at least one recognition electrode has at least one recognition protrusion which is a protrusion disposed at the part corresponding to the sample insertion channel.

## Claims

### Claim 1

A biosensor electrode structure for measuring a specimen, wherein a working electrode and a reference electrode that are electrodes for measuring the specimen are spaced apart from each other in a lengthwise direction of a specimen insertion passage,
wherein a working boss that is a boss of the working electrode and reference bosses that are two bosses of the reference electrode are alternately arranged in a part corresponding to the specimen insertion passage, and a ratio of an area of the working boss and an area of the reference bosses is 1 or more,
wherein at least one recognition electrode for recognizing the specimen is disposed adjacent to the working electrode or the reference electrode and is spaced apart from the working electrode and the reference electrode in parallel, and
wherein a recognition boss that is at least one boss is disposed in a part of the at least one recognition electrode, which corresponds to the specimen insertion passage.

### Claim 2 (depends on 1)

The biosensor electrode structure of claim 1, wherein the recognition boss is disposed to be adjacent to a distal end of the specimen insertion passage.

### Claim 3 (depends on 1)

The biosensor electrode structure of claim 1, wherein the at least one recognition electrode recognizes the specimen in response to a specimen recognition signal applied independently from a specimen measurement signal applied to the working electrode and the reference electrode.

### Claim 4 (depends on 1)

The biosensor electrode structure of claim 1, comprising:
a strip recognition electrode configured to detect a moment, at which a biosensor including the electrode structure is inserted into a measurer for measurement.

### Claim 5

A biosensor structure for measuring a specimen, the biosensor structure comprising:
a lower plate, in which a working electrode and a reference electrode that are electrodes for measuring a specimen, and at least one recognition electrode for recognizing the specimen are disposed in an insulation substrate, the working electrode and the reference electrode are spaced apart from each other in a lengthwise direction of a specimen insertion passage, a working boss that is a boss of the working electrode and reference bosses that are two bosses of the reference electrode are alternately arranged in a part corresponding to the specimen insertion passage, and a ratio of an area of the working boss and an area of the reference bosses is 1 or more, at least one recognition electrode is disposed adjacent to the working electrode or the reference electrode and is spaced apart from the working electrode and the reference electrode in parallel, and a recognition boss that is at least one boss is disposed at a part corresponding to the specimen insertion passage;
a middle plate having the specimen insertion passage, wherein an enzyme compound is inserted into the specimen insertion passage, and
an upper plate, in which an insertion hole for inserting the specimen and a discharge hole for discharging air are formed at parts of an insulation substrate, which correspond to the specimen insertion passage.

### Claim 6 (depends on 5)

The biosensor structure of claim 5, wherein the enzyme compound, when the specimen is saliva, includes:
an enzyme for causing a selective reaction of glucose included in the saliva;
a polymer for attaching the enzyme onto the electrodes disposed in the lower plate; and
a catalyst for expediting a reaction of the enzyme and the glucose,
wherein the enzyme includes:
1 unit to 30 units of at least one of glucose oxidase and glucose dehydrogenase (GDH),
wherein the polymer includes:
0.01 wt % to 1.0 wt % of at least one of chitosan, PVP, nafion, polyethylene glycol, poly vinyl pyrrolidone, poly vinyl alcohol, agarose, and trehalose, and
wherein the catalyst includes:
1% to 10% of at least one of Ferrocene, a Ferrocene derivative, Quinone, a Quinone derivative, hexamine ruthenium (III) chloride, and a ferricyanide.

### Claim 7 (depends on 6)

The biosensor structure of claim 6, wherein the catalyst includes 0.001% to 5% of Prussian blue.

### Claim 8 (depends on 5)

The biosensor structure of claim 5, wherein the at least one recognition electrode recognizes the specimen in response to a specimen recognition signal applied independently from a specimen measurement signal applied to the working electrode and the reference electrode.

### Claim 9

A system for measuring a specimen, the system comprising:
a collection device including a collection unit configured to collect a specimen, and a filter configured to remove interference materials that are obstructions in measuring the specimen collected by the collection unit;
a biosensor having an electrode structure, in which a working electrode and a reference electrode that are electrodes for measuring the specimen, from which the interference materials have been removed, and at least one recognition electrode for recognizing the specimen, from which the interference materials have been removed, are disposed in an insulation substrate, the working electrode and the reference electrode are spaced apart from each other in a lengthwise direction of a specimen insertion passage, a working boss that is a boss of the working electrode and reference bosses that are two bosses of the reference electrode are alternately arranged in a part corresponding to the specimen insertion passage, and a ratio of an area of the working boss and an area of the reference bosses is 1 or more, at least one recognition electrode is disposed adjacent to the working electrode or the reference electrode and is spaced apart from the working electrode and the reference electrode in parallel, and a recognition boss that is at least one boss is disposed at a part corresponding to the specimen insertion passage; and
a measurement device configured to, when the specimen, from which the interference materials have been removed through the collection device, is inserted into the biosensor after a strip of the biosensor is inserted, measure the specimen, from which the interference materials have been removed, based on a specimen measurement signal received through the working electrode and the reference electrode.

### Claim 10 (depends on 9)

The system of claim 9, wherein when the specimen is saliva, the filter removes big molecular materials and foreign substances, which are present in the saliva, and separates proteins, amylase, and ions that are obstructions in measuring sugar in the saliva.

### Claim 11 (depends on 9)

The system of claim 9, wherein the biosensor includes:
a lower plate having the electrode structure;
a middle plate having the specimen insertion passage, wherein an enzyme compound is inserted into the specimen insertion passage, and
an upper plate, in which an insertion hole for inserting the specimen, from which the interference materials have been removed, and a discharge hole for discharging air are formed at parts corresponding to the specimen insertion passage.

### Claim 12 (depends on 11)

The system of claim 11, wherein the enzyme compound, when the specimen is saliva, includes:
an enzyme for causing a selective reaction of glucose included in the saliva;
a polymer for attaching the enzyme onto the electrodes disposed in the lower plate; and
a catalyst for expediting a reaction of the enzyme and the glucose,
wherein the enzyme includes:
1 unit to 30 units of at least one of glucose oxidase and glucose dehydrogenase (GDH),
wherein the polymer includes:
0.01 wt % to 1.0 wt % of at least one of chitosan, PVP, nafion, polyethylene glycol, poly vinyl pyrrolidone, poly vinyl alcohol, agarose, and trehalose, and
wherein the catalyst includes:
1% to 10% of at least one of ferrocene, a ferrocene derivative, Quinone, a Quinone derivative, hexamine ruthenium (III) chloride, and a ferricyanide.

### Claim 13 (depends on 12)

The system of claim 12, wherein the catalyst includes 0.001% to 5% of Prussian blue.

### Claim 14

A method for measuring a specimen, the method comprising:
collecting a specimen by using a collection unit, and removing interference materials that are obstructions in measuring the specimen, from the collected specimen, by using a filter;
causing the specimen, from which the interference materials have been removed, to contact a biosensor; and
measuring a response signal to the specimen, from which the interference materials have been removed, by applying a specimen measurement signal to a working electrode and a reference electrode of the biosensor, when a contact of the specimen, from which the interference materials have been removed, is recognized by at least one recognition electrode of the biosensor,
wherein the working electrode and the reference electrode are spaced apart from each other in a lengthwise direction of a specimen insertion passage, a working boss that is a boss of the working electrode and reference bosses that are two bosses of the reference electrode are alternately arranged in a part corresponding to the specimen insertion passage, and a ratio of an area of the working boss and an area of the reference bosses is 1 or more, and at least one recognition electrode is disposed adjacent to the working electrode or the reference electrode and is spaced apart from the working electrode and the reference electrode in parallel, and a recognition boss that is at least one boss is disposed in a part corresponding to the specimen insertion passage.
