US 8,262,996 B2Granted

Small volume in vitro sensor and methods of making

AssigneeAbbott Diabetes Care Inc.

InventorsBenjamin J. Feldman, Adam Heller, Ephraim Heller, Fei Mao, Joseph A. Vivolo, Jeffery V. Funderburk, Fredric C. Colman, Rajesh Krishnan

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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.

Claims28

Dependent claims

A sensor for determining the concentration of an analyte in a sample fluid, the sensor comprising:

a working electrode and a counter electrode, wherein the working electrode and counter electrode are separated by an effective distance in a range of 25 to 1000 μm;
a sample chamber for holding the sample fluid, the sample chamber comprising the working electrode and the counter electrode, wherein the sample chamber is sized to contain a volume of no more than about 1 μL of the sample;
two indicator electrodes disposed in the sensor, wherein a first indicator electrode indicates when the sample chamber is beginning to fill with sample and a second indicator electrode indicates when the sample chamber is substantially filled with sample, and wherein the working electrode is disposed between the first and second indicator electrodes;
and
an analyte-responsive enzyme and a redox mediator disposed in the sample chamber.

2 more elements

Dependencies are inferred from the claim text.

Facts

Application: 12/568,930Filed 29 Sep 2009 · continuation
Priority: 8 Oct 1998
Published: US 2010/0012520 A121 Jan 2010
Granted: 11 Sep 2012
Term ends: Not estimatedThe source records don’t support an estimate.

Classification22 codes

G01N 27/3272
Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood: test elements therefor, i.e. disposable laminated substrates…
C12Q 1/001
Measuring or testing processes involving enzymes, nucleic acids or microorganisms ; Compositions therefor; Processes of preparing such…
C12Q 1/006
Involving specific analytes or enzymes: for glucose
C12Q 1/32
Involving oxidoreductase: involving dehydrogenase

Family

Application60/103,627Us provisional application · filed 8 Oct 1998
Application60/105,773Us provisional application · filed 8 Oct 1998
Application09/295,962Parent of this continuation · filed 21 Apr 1999
Application09/594,285Parent of this division · filed 15 Jun 2000
Application10/662,081Parent of this division · filed 12 Sep 2003
Application11/734,979Parent of this continuation · filed 13 Apr 2007
US 2010/0012520 A1Pre-grant publication · published 21 Jan 2010
US 7,225,535 B2Parent of this division
Application11/734,979Parent of this division
US 6,618,934 B1Parent of this division
US 6,338,790 B1Parent of this continuation
Application09/594,285Parent of this continuation
US 2004/0060818 A1Published application
US 2007/0193019 A1Published application
US 8,186,044 B2Related patent
US 8,262,996 B2This patent

From the US filing history. Foreign family members aren’t listed.