Source: https://patents.justia.com/patent/8980074
Timestamp: 2020-08-11 02:03:53
Document Index: 744819279

Matched Legal Cases: ['§371', 'Application No. 2000', 'Application No. 2000', 'Application No. 2000', 'Application No. 2000', 'Application No. 2000', 'art 1106', 'art 1106', 'art 4117', 'art.\n3']

US Patent for Biosensor, thin film electrode forming method, quantification apparatus, and quantification method Patent (Patent # 8,980,074 issued March 17, 2015) - Justia Patents Search
Justia Patents Disposable Apparatus Or Apparatus Having Removable Section (e.g., Removable Cartridge, Etc.)US Patent for Biosensor, thin film electrode forming method, quantification apparatus, and quantification method Patent (Patent # 8,980,074)
May 7, 2013 - Panasonic
This application is a continuation of U.S. patent application Ser. No. 12/930,627, filed Jan. 11, 2011, now U.S. Pat. No. 8,480,878, which is a continuation of U.S. patent application Ser. No. 10/809,217, filed Mar. 25, 2004, now U.S. Pat. No. 7,998,325, which is a continuation of U.S. patent application Ser. No. 09/889,243, filed Oct. 1, 2001, now U.S. Pat. No. 6,875,327, which is a national stage entry under 35 U.S.C. §371 of PCT International Patent Application No. PCT/JP00/08012, filed Nov. 14, 2000, which claims priority of Japanese patent application Ser. No. 11/324,551, filed Nov. 15, 1999, Japanese Patent Application No. 2000/111255, filed Apr. 12, 2000, Japanese Patent Application No. 2000/113754, filed Apr. 14, 2000, Japanese Patent Application No. 2000/124394, filed Apr. 25, 2000, Japanese Patent Application No. 2000/128249, filed Apr. 27, 2000, and Japanese Patent Application No. 2000/130158, filed Apr. 28, 2000, the contents of all of which are hereby incorporated by reference into the subject application.
A biosensor is a sensor which utilizes a molecule recognizing capacity of a biological material such as microorganisms, enzymes, antibodies, DNA, and RNA and applies a biological material as a molecular discrimination element to quantify a substrate included in a sample liquid. That the substrate included in the sample liquid is quantified by utilizing a reaction which is caused when a biological material recognizes an objective substrate, such as an oxygen consumption due to respiration of a microorganism, an enzyme reaction, and a luminous reaction. Among various biosensors, an enzyme sensor has progressively come into practical use, and an enzyme sensor as a biosensor for, for example, glucose, lactic acid, cholesterol, and amino acid is utilized in the medical diagnostics or food industry. This enzyme sensor reduces an electron transfer agent by an electron which is generated by a reaction of a substrate included in a sample liquid as a specimen and enzyme or the like, and a quantification apparatus electrochemically measures a reduction quantity of the transfer agent, thereby performing quantitative analysis of the specimen.
A reagent including enzyme or the like is applied to the counter electrode 1103a and the working electrode 1103b which are formed on the support 1101 as described above, whereby a reagent layer 1105 is formed, and a spacer 1106 having a cutout part 1106a for forming a specimen supply path and a cover 1107 having an air hole 1107a are further laminated thereon and bonded. One end of the cutout part 1106a of the spacer 1106 leads to tie air hole 1107a provided in the cover 1107. As shown in FIG. 21(b), the arrangements of the counter electrode 1103a and the working electrode 1103b which are formed on the support 1101 are such that the counter electrode 1103a is located at a position nearest to an inlet 1106b of the specimen supply path and the working electrode 1103b and the counter electrode 1103a are located in the inner part thereof.
The measuring device 4115 has correction data according to the output characteristics for each production lot, and subjects an output of the biosensor Z to the correction which is required for each production lot to obtain a correct blood, sugar level. Therefore, it is required to insert a correction chip (not shown here) which is specified for each production lot into the insertion opening 4116 of the measuring device 4115 before the measurement, thereby designating the required correction data to the measuring device 4115. The correction chip has information about the correction data to be used, and is inserted in the insertion opening 4116, whereby the measuring device 4115 prepares the required correction data. The correction chip taken out from the insertion opening 4116, the biosensor Z is inserted in the opening 4116 of the measuring device 4115, and then the substrate included in a specimen is quantified as described above. The measuring device 4115 to which a correction value is inputted as described above obtains a correct blood sugar level from a measured current value and correction data, and displays the blood sugar level at the display part 4117.
Further, only by applying the reagent on electrodes for the reagent layer formation, the reagent cannot uniformly be applied on the electrodes because of the surface state of the electrode or a difference in the way in which the reagent spreads due to reagent liquid composition, whereby variations in the reagent quantity on the electrodes occur. That is, even when the same amount of reagent is applied by dripping, variations in spread of the reagent occur, resulting in variations in position or area of the reagent layer. Therefore, the performance of the biosensor 2 is deteriorated.
According to the present invention, there is provided a biosensor for quantifying a substrate included in a sample liquid comprising: a first insulating support and a second insulating support; an electrode part comprising et least a working electrode and a counter electrode; a specimen supply path for introducing the sample liquid to the electrode part; and a reagent layer employed for quantifying the substrate included in the sample liquid, and the electrode part, the specimen supply path, and the reagent layer exist between the first insulating support and the second insulating support, the specimen supply path is provided on the electrode part, and the reagent layer is provided on the electrode part in the specimen supply path, respectively, and the electrode part is dividedly formed by first slits provided on an electrical conductive layer which is formed on the whole or part of an internal surface of one or both of the first insulating support and the second insulating support.
Since a biosensor is constructed as described above, an electrode part can be defined easily and with a high accuracy, and variations in response of each biosensor can be reduced, resulting in a favorable response. Further, the electrode part is formed in a monolayer of electrical conductive layer, whereby troubles can be reduced and an electrode part with a smooth surface can be formed by a simple method. Since the structure of the electrode part is quite simple, it possible to easily form biosensors having the same performance.
Like in the surface roughening processing for the surface of the support 81, it is subjected to the vacuum evacuation to a prescribed degree of vacuum (it can be within a range of 1×10−1 to 3×10−1 pascals). Thereafter, the vacuum chamber is filled up with an inert gas (the degree of vacuum after the filling is within a range of approximately 0.1 to 10 pascals), and a high-frequency voltage of approximately 0.01 to 5 KV is applied thereto, whereby the inert gas is excited and ionized. The ionized gas is collided against a target plate composed of a conductive material, whereby atoms of the conductive substance are beaten out and then deposited as a film on the support 81, thereby forming a thin film electrode layer. It is also possible that the vacuum evacuation is performed and thereafter the conductive substance is heated and evaporated so as to be deposited as a film on the support 81, thereby forming a thin film electrode layer. A typical one of the former manufacturing method is the sputtering evaporation, and a typical one of the latter is the vacuum evaporation.
1. A biosensor for quantifying a substrate in a sample liquid, the biosensor comprising: wherein:
an electrode pattern and an identification pattern formed of an electrically conductive material on a surface of the insulating support and having a thickness from 3 nm to 100 nm;
a reagent layer covering a portion of the electrode pattern;
a spacer layer covering a portion of the reagent layer; and
a cover on the spacer layer;
a portion of the reagent layer is in the supply path, and the supply path is narrower than the reagent layer;
the electrically conductive material comprises a noble metal;
the electrode pattern defines at least a working electrode and a counter electrode;
a portion of the working electrode and a portion of the counter electrode are in the supply path; and
no portion of the identification pattern is in the supply path.
2. The biosensor according to claim 1, wherein the identification pattern consists of one part.
3. The biosensor according to claim 1, wherein the identification pattern consists of two parts.
4. The biosensor according to claim 1, wherein the identification pattern consists of three parts.
5. The biosensor according to claim 1, wherein the identification pattern consists of more than three parts.
6. The biosensor according to claim 1, wherein the insulating support comprises a resin material.
7. The biosensor according to claim 1, wherein the noble metal is selected from the group consisting of palladium, platinum, gold, and ruthenium.
8. The biosensor according to claim 1, wherein the noble metal is gold.
9. The biosensor according to claim 1, wherein the electrode pattern has a thickness from 3 nm to 50 nm.
10. The biosensor according to claim 1, wherein the identification pattern has a thickness from 3 nm to 50 nm.
11. The biosensor according to claim 1, wherein the electrode pattern has a wettability index equal to or greater than 48 dyn/cm.
12. The biosensor according to claim 1, wherein the identification pattern has a wettability index equal to or greater than 48 dyn/cm.
13. The biosensor according to claim 1, wherein the reagent layer comprises an enzyme.
14. The biosensor according to claim 13, wherein the reagent layer further comprises an electron transfer agent.
15. The biosensor according to claim 14, wherein the reagent layer further comprises a hydrophilic polymer.
16. The biosensor according to claim 1, further comprising an air hole that leads to the supply path.
17. The biosensor according to claim 16, wherein the supply path is sufficiently narrow to draw in the sample liquid by capillary action.
18. The biosensor according to claim 1, wherein the portion of the counter electrode in the supply path is equal to or larger than the portion of the working electrode in the supply path.
19. The biosensor according to claim 1, wherein a portion of the counter electrode in the supply path is closer than any portion of the working electrode in the supply path to an inlet of the supply path.
20. The biosensor according to claim 1, wherein the working electrode and the counter electrode are separated by 0.005 mm to 0.3 mm in the supply path.
21. The biosensor according to claim 1, wherein the electrode pattern further defines a detecting electrode, and a portion of the detecting electrode is in the supply path.
22. The biosensor according to claim 21, wherein a portion of the counter electrode in the supply path is closer than any portion of the working electrode in the supply path to an inlet of the supply path, and the entire portion of the working electrode in the supply path is closer than any portion of the detecting electrode in the supply path to the inlet of the supply path.
23. The biosensor according to claim 21, wherein the detecting electrode is separated from the closest of the working electrode and the counter electrode by 0.005 mm to 0.3 mm in the supply path.
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Patent Publication Number: 20140158534
Application Number: 13/888,431
Current U.S. Class: Disposable Apparatus Or Apparatus Having Removable Section (e.g., Removable Cartridge, Etc.) (204/403.02); Enzyme Included In Apparatus (204/403.04)
International Classification: G01N 27/327 (20060101); C12Q 1/00 (20060101); G01N 33/487 (20060101);