SMALL VOLUME IN VITRO ANALYTE SENSOR

• US 20060169599A1
• Filed: 04/13/2006
• Published: 08/03/2006
• Est. Priority Date: 10/08/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Krishnan, Rajesh, Heller, Ephraim, Heller, Adam, Colman, Fredric C., Feldman, Benjamin J., Mao, Fei, Funderburk, Jeffery V., Vivolo, Joseph A.
• Granted Patent: US 8,728,297 B2
• Time in Patent Office: Days
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49004 including measuring or testing of device or component part
• CPC Class Codes: Y10T 29/49007 Indicating transducer
• CPC Class Codes: Y10T 29/49126 Assembling bases
• CPC Class Codes: Y10T 29/49128 Assembling formed circuit to base
• CPC Class Codes: Y10T 29/4913 Assembling to base an electrical component, e.g., capacitor, etc.
• CPC Class Codes: Y10T 29/49147 Assembling terminal to base
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing
• CPC Class Codes: Y10T 29/49208 by assembling plural parts
• CPC Class Codes: Y10T 29/4921 with bonding
• CPC Class Codes: Y10T 29/49794 Dividing on common outline

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.

Claims

11. A sensor for determining the concentration of glucose in a biological fluid sample, the sensor having a first end and an opposite second end, the sensor comprising:

a sample chamber sized to contain no more than about 1 μ

L of sample; and

a sample filling arrangement at the first end in fluid communication with the sample chamber, the sample filling arrangement configured to pull the sample into the chamber via capillary action.

1. A method for determining the concentration of glucose in a biological fluid sample from a subject, comprising the steps of:

providing a sensor comprising a sample chamber sized to contain no more than about 1 μ

L of sample, wherein the sample chamber is not a flow cell;

filling at least a portion of the sample chamber via capillary action with a biological fluid sample; and

determining the concentration of glucose from about 1 μ

L or less of sample in the sample chamber.

2. The method of claim 1, wherein determining the concentration of glucose from about 1 μ

L or less of sample comprises determining the concentration of glucose from about 1 μ

L or less of sample within a clinically acceptable degree of accuracy.

3. The method of claim 2, wherein determining the concentration of glucose from about 1 μ

L or less of sample comprises;

determining the concentration of glucose from about 0.5 μ

L or less of sample in the sample chamber.

4. The method of claim 3, wherein determining the concentration of glucose from about 0.5 μ

L or less of sample comprises;

determining the concentration of glucose from about 0.2 μ

L or less of sample in the sample chamber.

5. The method of claim 2, wherein:

providing a sensor comprises providing a sensor comprising a sample chamber sized to contain no more than about 0.5 μ

L of sample; and

determining the concentration of glucose comprises determining the concentration of glucose from about 0.5 μ

L or less of sample in the sample chamber.

6. The method of claim 5, wherein determining the concentration of glucose from about 0.5 μ

L or less of sample comprises;

determining the concentration of glucose from about 0.2 μ

L or less of sample in the sample chamber.

7. The method of claim 2, wherein:

providing a sensor comprises providing a sensor comprising a sample chamber sized to contain no more than about 0.2 μ

L of sample; and

determining the concentration of glucose comprises determining the concentration of glucose from about 0.2 μ

L or less of sample in the sample chamber.

8. The method of claim 1, further comprising:

obtaining the biological fluid sample from a finger of the subject.

9. The method of claim 1, further comprising:

obtaining the biological fluid sample from a location other than a finger of the subject.

10. The method of claim 9, wherein obtaining the biological fluid sample comprises obtaining the biological fluid sample from a forearm.

12. The sensor of claim 11, wherein the sensor is adapted to determine the concentration of glucose from about 1 μ

L or less of sample in the sample chamber within a clinically acceptable degree of accuracy.

13. The sensor of claim 12, wherein the sample chamber is sized to contain no more than about 0.5 μ

L of sample.

14. The sensor of claim 13, wherein the sample chamber is sized to contain no more than about 0.2 μ

L of sample.

15. The sensor of claim 14, wherein the sample chamber is sized to contain no more than about 0.1 μ

L of sample.

16. The sensor of claim 12, wherein the sample filling arrangement is a tip-fill arrangement.

17. The sensor of claim 16, wherein the first end is tapered.

18. The sensor of claim 12, wherein the sample filling arrangement is a side-fill arrangement.

15-1. The sensor of claim 12, further comprising a sorbent in the sample chamber.