Sensors

• US 7,967,962 B2
• Filed: 05/08/2009
• Issued: 06/28/2011
• Est. Priority Date: 11/17/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Scott, Steve
• Primary Examiner(s): Ruddock; Ula C
• Assistant Examiner(s): Kaur; Gurpreet
• Application Number:
  US12/463,211
• Publication Number:
  US 20090211923A1
• Time in Patent Office: 781 Days
• Field of Search: 204/400, 20440301-40306, 20440309-40314, 205/779, 205/792, 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. A sensor for determining the concentration of a ketone body 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 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.

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

L of sample.

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

6. A sensor for determining the concentration of a ketone body 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; and

a sample chamber adapted to determine the concentration of a ketone body 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;

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 adapted to determine the concentration of a ketone body using about 0.5 μ

L or less of sample in the sample chamber.

9. The sensor of claim 8, wherein the sensor is adapted to determine the concentration of a ketone body using about 0.2 μ

L or less of sample in the sample chamber.

10. The sensor of claim 8, wherein the sensor is adapted to determine the concentration of a ketone body using about 0.1 μ

L or less of sample in the sample chamber.

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

L of sample.

12. The sensor of claim 11, wherein the sample chamber is configured to contain no more than about 0.5 μ

L of sample.

13. The sensor of claim 12, wherein the sample chamber is configured to contain no more than about 0.2 μ

L of sample.

14. The sensor of claim 13, wherein the sample chamber is configured to contain no more than about 0.1 μ

L of sample.

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

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

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

18. The sensor of claim 6, wherein the distance between a sample chamber edge and the distal edge ranges from about 0.01 mm to about 1.5 mm.

19. A ketone body sensor comprising:

a first substrate separated from a second substrate by a spacer layer and including at least one electrode, the first and second substrates forming a 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. A method for determining a ketone body concentration in a sample of biological fluid, the method 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;

applying, after connecting the sensor to the meter, an ketone body-containing sample to the analyte sensor by contacting the first or the second corner of the sensor with the sample; and

determining the concentration of a ketone body in the sample.

21. The method of claim 20, wherein the concentration of the ketone body is determined using about 1 μ

L or less of sample in the sample chamber.

22. The method of claim 21, wherein the concentration of the ketone body is determined using about 0.5 μ

L or less of sample in the sample chamber.

23. The method of claim 22, wherein the concentration of the ketone body is determined using about 0.2 μ

L or less of sample in the sample chamber.

24. The method of claim 23, wherein the concentration of the ketone body is determined using about 0.1 μ

L or less of sample in the sample chamber.

25. The method of claim 20, wherein the sample chamber is sized to contain no more than about 1 μ

L of sample.

26. The method of claim 20, wherein the ketone body concentration is determined using photometry.

27. The method of claim 20, wherein the determining comprises a measurement technique involving an electrochemical measurement in the sensor.

28. The method of claim 27, wherein the measurement technique comprises amperometry.

29. The method of claim 27, wherein the measurement technique comprises coulometry.

30. The method of claim 27, wherein the measurement technique comprises potentiometry.

31. The method of claim 27, wherein the measurement technique comprises impedance measurement.

32. An integrated device for determining the concentration of a ketone body in sample, the system comprising:

a housing comprising a sensor and a processor adapted for determining the concentration of a ketone 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.