US5437999A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Electrochemical sensor
Assignee: Roche Diabetes Care Inc
•
Filing: 1994-02-22
•
Granted: 1995-08-01
•
Expires: 2014-02-22
Abstract
Abstract A method for fabricating high-resolution, biocompatible electrodes is disclosed, allowing production of an electrochemical sensor which is capable of precise analyte concentration determination on a very small sample size. Electrically conducting material is affixed to a first insulating substrate. A second insulating substrate is then affixed to the electrically conducting material and patterned using photolithography to define an electrode area. Alternatively, the electrically conducting material may be screen printed directly onto a standard printed circuit board substrate in the case of a counter or reference electrode. In either case, the substrate may be rigid or flexible. When the electrodes produced in accordance with the present invention are then used in an electrochemical sensor which includes a reagent, the small and highly-defined electrode areas permit highly-accurate electrochemical analyte measurements to be performed on very small sample sizes.
Inventors
- 👤 Eric R. Diebold
- 👤 Richard J. Kordal
- 👤 Nigel A. Surridge
- 👤 Christopher D. Wilsey
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 22:10
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/001; G; G01; G01N; G01N27/00; G01N27/26; G01N27/28; G01N27/30; G01N27/327; G01N27/3271; G01N27/3272; Y; Y10; Y10S; Y10S435/00; Y10S435/817
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
219 words
An electrochemical sensor useful for measuring the concentration of an analyte in a fluid sample, comprising: (a) opposing working and counter electrode elements, spatially displaced by a spacer having a first cutout portion forming a capillary space between the working and counter electrode elements and a second cutout portion allowing electrical connection between the counter electrode element and a meter and power source, wherein the capillary space is vented by a port in the working or counter electrode elements, the working electrode element including 1) a first insulating substrate, 2) an electrically conducting material affixed to the first insulating substrate, and 3) a second insulating substrate affixed to the electrically conducting material and the spacer, the second insulating substrate having a first cutout portion for exposing a portion of the electrically conducting material to the capillary space and a second cutout portion which allows contact between the electrically conducting material and the meter and power source, the counter electrode element including 1) an insulating substrate, and 2) an electrically conducting material affixed to the insulating substrate and the spacer; and (b) a reagent disposed in the capillary space, the reagent being specifically reactive with the analyte in the fluid sample to produce an electrochemically-measurable signal which can be correlated to the concentration of the analyte in the fluid sample.
Claim 2
Dependent Claim
219 words
An electrochemical sensor useful for measuring the concentration of an analyte in a fluid sample, comprising: (a) opposing working and counter electrode elements, spatially displaced by a spacer having a first cutout portion forming a capillary space between the working and counter electrode elements and a second cutout portion allowing electrical connection between the counter electrode element and a meter and power source, wherein the capillary space is vented by a port in the working or counter electrode elements, the working electrode element including 1) a first insulating substrate, 2) an electrically conducting material affixed to the first insulating substrate, and 3) a second insulating substrate affixed to the electrically conducting material and the spacer, the second insulating substrate having a first cutout portion for exposing a portion of the electrically conducting material to the capillary space and a second cutout portion which allows contact between the electrically conducting material and the meter and power source, the counter electrode element including 1) an insulating substrate, and 2) an electrically conducting material affixed to the insulating substrate and the spacer; and (b) a reagent disposed in the capillary space, the reagent being specifically reactive with the analyte in the fluid sample to produce an electrochemically-measurable signal which can be correlated to the concentration of the analyte in the fluid sample.
Claim 3
Dependent Claim
21 words
The electrochemical sensor of claim 1, wherein the vent port extends through the working electrode element and the counter electrode element.
Claim 4
Dependent Claim
63 words
The electrochemical sensor of claim 2, wherein the counter electrode element further comprises: 3) a second insulating substrate affixed to the electrically conducting material and the spacer, the second insulating substrate having a first cutout portion for exposing a portion of the electrically conducting material to the capillary space and a second cutout portion which overlays the second cutout portion of the spacer.
Claim 5
Dependent Claim
22 words
The electrochemical sensor of claim 3, wherein the electrically conducting material of the working electrode element is a noble metal or carbon.
Claim 6
Dependent Claim
22 words
The electrochemical sensor of claim 4, wherein the electrically conducting material of the counter electrode element is a noble metal or carbon.
Claim 7
Dependent Claim
15 words
The electrochemical sensor of claim 5, wherein the second insulating substrate is a solder resist.
Claim 8
Dependent Claim
41 words
The electrochemical sensor of claim 6, further comprising: (d) the power source in electrical connection with the working and counter electrode elements; and (e) the meter in electrical connection with the working and counter electrode elements and capable of measuring current.
Claim 9
Dependent Claim
15 words
The electrochemical sensor of claim 7, wherein the reagent comprises a mediator and an enzyme.
Claim 10
Dependent Claim
19 words
The electrochemical sensor of claim 8, wherein the reagent further comprises a buffer, a film former, and a surfactant.
Claim 11
Dependent Claim
44 words
The electrochemical sensor of claim 9, wherein the analyte is glucose, the mediator is [Os(II)(bpy) 2 (im)Cl] + [Cl] - , the enzyme is glucose oxidase, the buffer is MES buffer, the film former is polyvinyl alcohol, and the surfactant is a nonionic surfactant.
Claim 12
Dependent Claim
22 words
The electrochemical sensor of claim 8, wherein the mediator is Os(II)(bpy) 2 (im)Cl] + [Cl] - and the enzyme is glucose oxidase.
Claim 13
Dependent Claim
219 words
An electrochemical sensor useful for measuring the concentration of an analyte in a fluid sample, comprising: (a) opposing working and reference electrode elements, spatially displaced by a spacer having a first cutout portion forming a capillary space between the working and reference electrode elements and a second cutout portion allowing electrical connection between the reference electrode element and a meter and power source, wherein the capillary space is vented by a port in the working or reference electrode elements, the working electrode element including 1) a first insulating substrate, 2) an electrically conducting material affixed to the first insulating substrate, and 3) a second insulating substrate affixed to the electrically conducting material and the spacer, the second insulating substrate having a first cutout portion for exposing a portion of the electrically conducting material to the capillary space and a second cutout portion which allows contact between the electrically conducting material and the meter and power source, the reference electrode element including 1) an insulating substrate, 2) an electrically conducting reference material affixed to the insulating substrate and the spacer; and (b) a reagent disposed in the capillary space, the reagent being specifically reactive with the analyte in the fluid sample to produce an electrochemically-measurable signal which can be correlated to the concentration of the analyte in the fluid sample.
Claim 14
Dependent Claim
219 words
An electrochemical sensor useful for measuring the concentration of an analyte in a fluid sample, comprising: (a) opposing working and reference electrode elements, spatially displaced by a spacer having a first cutout portion forming a capillary space between the working and reference electrode elements and a second cutout portion allowing electrical connection between the reference electrode element and a meter and power source, wherein the capillary space is vented by a port in the working or reference electrode elements, the working electrode element including 1) a first insulating substrate, 2) an electrically conducting material affixed to the first insulating substrate, and 3) a second insulating substrate affixed to the electrically conducting material and the spacer, the second insulating substrate having a first cutout portion for exposing a portion of the electrically conducting material to the capillary space and a second cutout portion which allows contact between the electrically conducting material and the meter and power source, the reference electrode element including 1) an insulating substrate, 2) an electrically conducting reference material affixed to the insulating substrate and the spacer; and (b) a reagent disposed in the capillary space, the reagent being specifically reactive with the analyte in the fluid sample to produce an electrochemically-measurable signal which can be correlated to the concentration of the analyte in the fluid sample.
Claim 15
Dependent Claim
21 words
The electrochemical sensor of claim 12, wherein the vent port extends through the working electrode element and the reference electrode element.
Claim 16
Dependent Claim
63 words
The electrochemical sensor of claim 13, wherein the reference electrode element further comprises: 4) a second insulating substrate affixed to the reference electrode material and the spacer, the second insulating substrate having a first cutout portion for exposing a portion of the electrically conducting material to the capillary space and a second cutout portion which overlays the second cutout portion of the spacer.
Claim 17
Dependent Claim
22 words
The electrochemical sensor of claim 14, wherein the electrically conducting material of the working electrode element is a noble metal or carbon.
Claim 18
Dependent Claim
20 words
The electrochemical sensor of claim 15, wherein the electrically conducting reference material of the reference electrode element is silver/silver chloride.
Claim 19
Dependent Claim
15 words
The electrochemical sensor of claim 16, wherein the second insulating substrate is a solder resist.
Claim 20
Dependent Claim
41 words
The electrochemical sensor of claim 17, further comprising: (d) the power source in electrical connection with the working and reference electrode elements; and (e) the meter in electrical connection with the working and reference electrode elements and capable of measuring current.
Claim 21
Dependent Claim
16 words
The electrochemical sensor of claim 18, wherein the reagent comprises a redox mediator and an enzyme.
Claim 22
Dependent Claim
19 words
The electrochemical sensor of claim 19, wherein the reagent further comprises a buffer, a film former, and a surfactant.
Claim 23
Dependent Claim
45 words
The electrochemical sensor of claim 20, wherein the analyte is glucose, the redox mediator is [Os(II)(bpy) 2 (im)Cl] + [Cl] - , the enzyme is glucose oxidase, the buffer is MES buffer, the film former is polyvinyl alcohol, and the surfactant is a nonionic surfactant.
Claim 24
Dependent Claim
23 words
The electrochemical sensor of claim 19, wherein the redox mediator is [Os(II)(bpy) 2 (im)Cl] + [Cl] - and the enzyme is glucose oxidase.
References Cited (Backward Citations)
GB2073891A
Cited
US4571292A
Cited
EP0127958B1
Cited
US5141868A
Cited
JPS6285855A
Cited
JPS6429155A
Cited
US5108564A
Cited
JPH02120655A
Cited
WO1990005300A1
Cited
WO1990005910A1
Cited
JPH0326956A
Cited
US5229282A
Cited
US5108819A
Cited
JPH0572171A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1998-07-31 | 1999-01-30 | 1999-08-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-07-31 | 2003-01-30 | 2003-08-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-07-31 | 2007-01-30 | 2007-08-01 | $7700.00 | Window Closed / Lapsed |