Analytical sensors for biological fluid

• US 7,918,975 B2
• Filed: 11/17/2005
• Issued: 04/05/2011
• Est. Priority Date: 11/17/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Scott, Steve, Wang, Yi
• Primary Examiner(s): Ruddock; Ula C
• Assistant Examiner(s): Kaur; Gurpreet
• Application Number:
  US11/282,001
• Publication Number:
  US 20070108048A1
• Time in Patent Office: 1,965 Days
• Field of Search: 204/403.02, 204/400, 20440301-40306, 20440309-40314, 205/792, 205/779, 205/775
• US Class Current: 204/403.01
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• 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 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte

Abstract

The subject invention provides devices and methods for the analysis of a body fluid. Embodiments include sensors that are sample-fillable by contacting a corner of the sensor to a sample.

Claims

1. An analyte sensor for determining the concentration of an analyte in a sample of biological fluid, the sensor comprising:

a working electrode and a counter electrode;

a first corner of the sensor at the intersection of a first side edge and a distal edge of the sensor and a second corner of the sensor at the intersection of a second side edge and the distal edge of the sensor; and

a sample chamber for receiving biological fluid, wherein the sample chamber includes at least a portion of the working and counter electrodes and wherein the sample chamber only has a first and a second entrance for admitting the biological fluid, the first entrance positioned at the first corner and the second entrance positioned at the second corner,

wherein the sample chamber is adapted to receive the biological fluid by contacting the first corner or the second corner of the sensor with the biological fluid.

2. The sensor of claim 1, wherein the sensor is adapted to determine the concentration of an analyte using about 1 μ

L or less of sample in the sample chamber.

3. The sensor of claim 1, wherein the sample chamber is configured to contain no more than about 1 μ

L of sample.

4. The sensor of claim 1, wherein the corners are substantially rounded.

5. The sensor of claim 1, wherein the corners are substantially squared.

21. The sensor of claim 1, wherein the analyte is glucose.

22. The sensor of claim 1, wherein the analyte is a ketone.

23. The sensor of claim 1, wherein the sample chamber is configured to contain no more than about 0.5 μ

L of sample.

24. The sensor of claim 1, wherein the first side edge and the second side edge are parallel to each other.

6. An analyte sensor for determining the concentration of an analyte in a biological fluid sample, the sensor comprising:

a first side edge, a second side edge, a proximal edge and a distal edge, wherein the distal edge is parallel to the proximal edge;

a first corner of the sensor at the intersection of the first side edge and the distal edge of the sensor and a second corner of the sensor at the intersection of the second side edge and the distal edge of the sensor;

a sample chamber adapted to determine the concentration of an analyte in less than about 1 μ

L of sample, wherein the sample chamber only has a first and a second chamber opening for admitting the sample to the sample chamber; and

wherein the first chamber opening is positioned at the first corner and the second chamber opening is positioned at the second corner of the sensor.

7. The sensor of claim 6, wherein the sensor is formed in a substantially rectangular shape.

8. The sensor of claim 6, wherein the sensor is a glucose sensor.

9. The sensor of claim 6, wherein the sensor is adapted to determine the concentration of an analyte using about 0.5 μ

L or less of sample in the sample chamber.

10. The sensor of claim 9, wherein the sensor is adapted to determine the concentration of an analyte using about 0.2 μ

L or less of sample in the sample chamber.

11. The sensor of claim 9, wherein the sensor is adapted to determine the concentration of an analyte using about 0.1 μ

L or less of sample in the sample chamber.

12. The sensor of claim 6, wherein the sample chamber is configured to contain no more than about 1 μ

L of sample.

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

L of sample.

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

L of sample.

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

L if sample.

16. The sensor of claim 6, wherein the sensor is an electrochemical sensor.

17. The sensor of claim 6, wherein the sensor is an optical sensor.

18. The sensor of claim 6, wherein the proximal edge is operatively connectable with a meter.

19. An analyte sensor comprising:

a first side edge opposite to a second side edge, a distal edge opposite and parallel to a proximal edge, wherein the distal edge is shorter than the proximal edge;

a first corner of the sensor at the intersection of the first side edge and the distal edge of the sensor and a second corner of the sensor at the intersection of the second side edge and the distal edge of the sensor;

a sample chamber; and

only a first and a second chamber opening for admitting sample to the sample chamber, wherein the first sample chamber opening is located at the first corner and the second sample chamber opening is located at the second corner of the sensor.

20. An integrated device for determining the concentration of an analyte in sample, the system comprising:

a housing comprising a sensor and a processor adapted for determining the concentration of an analyte in a sample applied to the sensor, the sensor comprising;

a working electrode and a counter electrode;

a first corner of the sensor at the intersection of a first side edge and a distal edge of the sensor and a second corner of the sensor at the intersection of a second side edge and the distal edge of the sensor; and

a sample chamber, wherein the sample chamber includes at least a portion of the working and counter electrodes and wherein the sample chamber only has a first and a second entrance for admitting sample to the sample chamber, the first entrance positioned at the first corner and the second entrance positioned at the second corner,

wherein the sample chamber is adapted to receive the sample by contacting the first corner or the second corner of the sensor with the biological fluid.