US6299757B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
Assignee: Abbott Diabetes Care Inc
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Filing: 1999-10-06
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Granted: 2001-10-09
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Expires: 2019-10-06
Abstract
Abstract A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.
Inventors
- 👤 Benjamin J. Feldman
- 👤 Adam Heller
- 👤 Ephraim Heller
- 👤 Fei Mao
- 👤 Joseph A. Vivolo
- 👤 Jeffery V. Funderburk
- 👤 Fredric C. Colman
- 👤 Rajesh Krishnan
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 07:32
CPC Classifications
G; G01; G01N; G01N27/00; G01N27/26; G01N27/28; G01N27/30; G01N27/327; G01N27/3271; G01N27/3272; C; C12; C12Q; C12Q1/00; C12Q1/001; C12Q1/005; C12Q1/006; C12Q1/26; C12Q1/32; G01N27/3274; Y; Y10; Y10T; Y10T156/00; Y10T156/10; Y10T156/1052; Y10T29/00; Y10T29/49; Y10T29/49002; Y10T29/49004; Y10T29/49007; Y10T29/49117; Y10T29/49124; Y10T29/49126; Y10T29/49128; Y10T29/4913; Y10T29/49147; Y10T29/49155; Y10T29/49204; Y10T29/49208; Y10T29/4921; Y10T29/49789; Y10T29/49794
Claims Analysis
Total Claims: 37
Claim 1
Independent Claim
247 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate, the distal end being configured and arranged for insertion into a sensor reader; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on at least one of the first and second substrates; (e) at least one counter electrode disposed on at least one of the first and second substrates, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates and positioned relative to a sample flow path within the sample chamber to indicate that, when sample contacts a one of the at least one indicator electrode, the sample chamber is filled with sample.
Claim 2
Dependent Claim
247 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate, the distal end being configured and arranged for insertion into a sensor reader; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on at least one of the first and second substrates; (e) at least one counter electrode disposed on at least one of the first and second substrates, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates and positioned relative to a sample flow path within the sample chamber to indicate that, when sample contacts a one of the at least one indicator electrode, the sample chamber is filled with sample.
Claim 3
Dependent Claim
24 words
The sensor of claim 1 , wherein portions of the first and second side edges proximate to the first and second apertures are straight.
Claim 4
Dependent Claim
29 words
The sensor of claim 1 , wherein the sample chamber comprises two opposing straight edges extending between the first and second openings of the first and second side edges.
Claim 5
Dependent Claim
24 words
The sensor of claim 1 , wherein the at least one indicator electrode is configured and arranged to aid in electrolysis of the analyte.
Claim 6
Dependent Claim
63 words
The sensor of claim 1 , wherein the at least one indicator electrode comprises first and second indicator electrodes, the first indicator electrode is positioned relative to the sample chamber to determine when the sample chamber begins to fill with sample and the second indicator electrode is positioned relative to the sample chamber to determine when the sample chamber is filled with sample.
Claim 7
Dependent Claim
32 words
The sensor of claim 5 , wherein a one of the at least one working electrodes and the at least one counter electrodes is positioned between the first and second indicator electrodes.
Claim 8
Dependent Claim
31 words
The sensor of claim 1 , wherein the sample chamber comprises two opposing edges between the first and second side edges, the edges defining an expanded region in the sample chamber.
Claim 9
Dependent Claim
17 words
The sensor of claim 1 , further comprising a diffusible redox mediator disposed in the sample chamber.
Claim 10
Dependent Claim
24 words
The sensor of claim 8 , wherein the diffusible redox mediator is disposed on at least one of the at least one working electrodes.
Claim 11
Dependent Claim
43 words
The sensor of claim 8 , wherein the sensor is configured and arranged so that a background signal generated by the diffusible redox mediator is no more than five times a signal generated by electrolysis of an average normal physiological amount of analyte.
Claim 12
Dependent Claim
18 words
The sensor of claim 1 , further comprising a second electron transfer agent disposed in the sample chamber.
Claim 13
Dependent Claim
25 words
The sensor of claim 11 , wherein the second electron transfer agent is disposed on at least one of the at least one working electrodes.
Claim 14
Dependent Claim
14 words
The sensor of claim 11 , wherein the second electron transfer agent is diffusible.
Claim 15
Dependent Claim
41 words
The sensor of claim 4 , wherein the at least one working electrode is disposed on the first substrate and extends over substantially all of the sample chamber and the at least one counter electrode is disposed on the second substrate.
Claim 16
Dependent Claim
41 words
The sensor of claim 4 , wherein the at least one counter electrode is disposed on the second substrate and extends over substantially all of the sample chamber and the at least one working electrode is disposed on the first substrate.
Claim 17
Dependent Claim
23 words
The sensor of claim 1 , wherein the sample chamber is sized to contain a volume of no more 1 μl of sample.
Claim 18
Dependent Claim
24 words
The sensor of claim 1 , wherein the sample chamber is sized to contain a volume of no more than 0.5 μL of sample.
Claim 19
Dependent Claim
72 words
The sensor of claim 1 , wherein the at least one working electrode is disposed on the first substrate, the at least one counter electrode is disposed on the second substrate, and the at least one working electrode is in a facing relationship to the at least one counter electrode and at least a portion of the working electrode is no more than 200 μm from a portion of the counter electrode.
Claim 20
Dependent Claim
27 words
The sensor of claim 1 , wherein at least one of the at least one indicator electrode is configured and arranged for use as a counter electrode.
Claim 21
Dependent Claim
27 words
The sensor of claim 1 , wherein at least one of the at least one indicator electrode is configured and arranged for use as a working electrode.
Claim 22
Dependent Claim
58 words
The sensor of claim 1 , wherein the at least one indicator electrode is disposed on at least one of the first and second substrates and positioned, relative to a sample flow path within the sample chambers after at least one of the working and counter electrodes to indicate when the sanple chamber is sufficiently filled with sample.
Claim 23
Dependent Claim
227 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the proximal end of the sensor, a second aperture along the first side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on at least one of the first and second substrates; (e) at least one counter electrode disposed on at least one of the first and second substrates, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates and positioned relative to the sample chamber to determine when the sample chamber contains sample.
Claim 24
Dependent Claim
227 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the proximal end of the sensor, a second aperture along the first side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on at least one of the first and second substrates; (e) at least one counter electrode disposed on at least one of the first and second substrates, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates and positioned relative to the sample chamber to determine when the sample chamber contains sample.
Claim 25
Dependent Claim
21 words
The sensor of claim 22 , wherein a portion of the first side edge proximate to the second aperture is straight.
Claim 26
Dependent Claim
216 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on the first substrate; (e) at least one counter electrode disposed on the second substrate, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates and positioned relative to the sample chamber to determine when the sample chamber contains sample.
Claim 27
Dependent Claim
216 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on the first substrate; (e) at least one counter electrode disposed on the second substrate, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates and positioned relative to the sample chamber to determine when the sample chamber contains sample.
Claim 28
Dependent Claim
231 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate, the distal end being configured and arranged for insertion into a sensor reader; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on at least one of the first and second substrates; (e) at least one counter electrode disposed on at least one of the first and second substrates, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates wherein the at least one indicator electrode is configured and arranged to aid in electrolysis of the analyte.
Claim 29
Dependent Claim
231 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate, the distal end being configured and arranged for insertion into a sensor reader; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on at least one of the first and second substrates; (e) at least one counter electrode disposed on at least one of the first and second substrates, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates wherein the at least one indicator electrode is configured and arranged to aid in electrolysis of the analyte.
Claim 30
Dependent Claim
258 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on the first substrate; (e) at least one counter electrode disposed on the second substrate, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates, wherein the at least one indicator electrode comprises first and second indicator electrodes, the first indicator electrode is positioned relative to the sample chamber to determine when the sample chamber begins to fill with sample and the second indicator electrode is positioned relative to the sample chamber to determine when the sample chamber is filled with sample.
Claim 31
Dependent Claim
258 words
A sensor for determining a concentration of an analyte in a sample, the sensor comprising: (a) a first substrate having a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, the first substrate defining a first side edge and a second side edge of the sensor extending from the proximal end to the distal end of the first substrate; (b) a second substrate disposed over the first substrate; (c) a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending from the first aperture to the second aperture; (d) at least one working electrode disposed on the first substrate; (e) at least one counter electrode disposed on the second substrate, wherein the at least one working electrode and the at least one counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and (f) at least one indicator electrode disposed on at least one of the first and second substrates, wherein the at least one indicator electrode comprises first and second indicator electrodes, the first indicator electrode is positioned relative to the sample chamber to determine when the sample chamber begins to fill with sample and the second indicator electrode is positioned relative to the sample chamber to determine when the sample chamber is filled with sample.
Claim 32
Independent Claim
167 words
A method of monitoring an analyte an electrochemical sensor, the method comprising: contacting a sample with an aperture defined between two substrates of an electrochemnical scraper comprising at least one working electrode disposed on a one of the two substrates; drawing at least a portion of the sample through the aperture and into a sample chamber disposed between the two substrates; observing an indicator electrode disposed on a one of the two substrates, wherein the indicator electrode is positioned within the sensor to indicate, when the sample contacts the working electrode and then subsequently contacts the indicator electrode, that the sample chamber is sufficiently full for monitoring the analyte using the sensor; and generating an analyte-responsive signal using the at least one working electrode and at least one counter electrode disposed on a one of the two substrates, wherein the at least one working electrode and at least one counter electrode are separate from the indicator electrode and are disposed in electrolytic contact with the sample chamber.
Claim 33
Independent Claim
167 words
A method of monitoring an analyte an electrochemical sensor, the method comprising: contacting a sample with an aperture defined between two substrates of an electrochemnical scraper comprising at least one working electrode disposed on a one of the two substrates; drawing at least a portion of the sample through the aperture and into a sample chamber disposed between the two substrates; observing an indicator electrode disposed on a one of the two substrates, wherein the indicator electrode is positioned within the sensor to indicate, when the sample contacts the working electrode and then subsequently contacts the indicator electrode, that the sample chamber is sufficiently full for monitoring the analyte using the sensor; and generating an analyte-responsive signal using the at least one working electrode and at least one counter electrode disposed on a one of the two substrates, wherein the at least one working electrode and at least one counter electrode are separate from the indicator electrode and are disposed in electrolytic contact with the sample chamber.
Claim 34
Dependent Claim
49 words
The method of claim 27 , further comprising observing a second indicator electrode disposed on a one of the two substrates, wherein the second indicator electrode is positioned within the sensor to indicate, when sample contact the indicator electrode, that the sample chamber is beginning to fill with sample.
Claim 35
Dependent Claim
33 words
The method of claim 27 , wherein generating an analyte-responsive signal comprises generating the analyte-responsive signal using the at least one working electrode, the at least one counter electrode, and the indicator electrode.
Claim 36
Dependent Claim
27 words
The method of claim 27 , wherein the step of generating an analyte-responsive signal occurs simultaneously with and continues after the step of observing the indicator electrode.
Claim 37
Dependent Claim
24 words
The method of claim 28 , wherein the step of generating an analyte responsive signal occurs after the step of observing the indicator electrode.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-10-08 | 2005-04-09 | 2005-10-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-10-08 | 2009-04-09 | 2009-10-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-10-08 | 2013-04-09 | 2013-10-09 | $7700.00 | Window Closed / Lapsed |