Analyte sensors and methods of use

• US 8,083,927 B2
• Filed: 05/08/2009
• Issued: 12/27/2011
• Est. Priority Date: 03/29/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Feldman, Benjamin J., Watkin, Jared L.
• Primary Examiner(s): Barton, Jeffrey T
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US12/463,206
• Publication Number:
  US 20090240166A1
• Time in Patent Office: 963 Days
• Field of Search: 20440301-412, 205/787, 205/777.5, 205/792, 205/775
• US Class Current: 205/792
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing

Abstract

In vitro analyte sensors and methods of analyte determination are provided. Embodiments include sensors that include a pair of electrodes to monitor filling of the sample chamber with sample.

Claims

1. A method of analyzing a ketone body in a biological fluid sample, the method comprising:

contacting an inlet region of a biosensor having multi-directional fill capabilities with the sample to provide sample into a sample chamber of the sensor, the sensor comprising;

a first electrode pair, wherein electrodes of the first electrode pair are spaced in a lateral direction with respect to each other in the sample chamber, and

a second electrode pair, wherein electrodes of the second electrode pair each comprise an electrode portion and a trace portion and wherein entire electrode portions of the electrodes of the second electrode pair are spaced in a longitudinal direction with respect to each other in the sample chamber,

wherein the second electrode pair is positioned in between the first electrode pair,

the first and second electrode pairs placed on a first surface within the sample chamber, the first electrode pair being a pair of indicator electrodes;

contacting the indicator electrode pair with the sample in the sample chamber; and

after contacting each electrode of the indicator electrode pair with the sample, beginning analysis of the ketone body at the second electrode pair.

2. The method of claim 1, wherein the method further comprises determining a signal differential by comparing signal from an electrode of the second electrode pair to its surface area and comparing signal from another electrode of the second electrode pair to its surface area.

3. The method of claim 2, further comprising discarding the analysis if the signal differential is not within acceptable limits.

4. A method of analyzing a ketone body in a biological fluid sample, the method comprising:

contacting an inlet region of a biosensor having multi-directional fill capabilities with the sample to provide sample into a sample chamber of the sensor;

contacting a first electrode pair and a second electrode pair with the sample in the sample chamber,

wherein electrodes of the first electrode pair are spaced in a lateral direction with respect to each other in the sample chamber, wherein electrodes of the second electrode pair each comprise an electrode portion and a trace portion and wherein entire electrode portions of the electrodes of the second electrode pair are spaced in a longitudinal direction with respect to each other in the sample chamber, and wherein the second electrode pair is positioned in between the first electrode pair;

determining if the sample is sufficiently filled; and

analyzing of the ketone body.

5. An integrated system for determining concentration of a ketone body in biological fluid, the system comprising:

a housing having an interior space;

at least one sensor for determining the concentration of ketone body in a sample positioned in the interior space, the sensor comprising a sample chamber configured for multi-directional fill, and at least a first electrode pair, wherein electrodes of the first electrode pair are spaced in a lateral direction with respect to each other in the sample chamber, and

a second electrode pair, wherein electrodes of the second electrode pair each comprise an electrode portion and a trace portion and wherein entire electrode portions of the electrodes of the second electrode pair are spaced in a longitudinal direction with respect to each other in the sample chamber,

wherein the second electrode pair is positioned in between the first electrode pair, and the first and second electrode pairs placed on a first arrangement surface; and

a processor for determining the concentration of ketone body.

6. The integrated system of claim 5, further comprising a skin-piercing element.

7. A sensor for determining the concentration of a ketone body in a sample, the sensor comprising:

a sample chamber;

a first electrode pair, wherein electrodes of the first electrode pair are spaced in a lateral direction with respect to each other in the sample chamber,

a second electrode pair, wherein electrodes of the second electrode pair each comprise an electrode portion and a trace portion and wherein entire electrode portions of the electrodes of the second electrode pair are spaced in a longitudinal direction with respect to each other in the sample chamber,

wherein the second electrode pair is positioned in between the first electrode pair; and

sensing chemistry for determining concentration of ketone body in a sample.

8. The sensor of claim 7, wherein about 10% to about 95% of the perimeter of the sample chamber is unbounded.

9. The sensor of claim 8, wherein about 50% to about 95% of the perimeter of the sample chamber is unbounded.

10. The sensor of claim 7, wherein the sample chamber comprises at least two unbounded sides.

11. The sensor of claim 10, wherein the sample chamber comprises three unbounded sides.

12. The sensor of claim 7, wherein the sensor comprises a first substrate and a second substrate, a spacer between the first substrate and the second substrate, together the first substrate, second substrate and spacer defining at least a portion of the sample chamber.

13. The sensor of claim 12, wherein the first electrode pair and the second electrode pair are on the first substrate.

14. The sensor of claim 7, wherein the sample chamber has a volume of no more than about 1 microliter.

15. The sensor of claim 14, wherein the sample chamber has a volume of no more than about 0.5 microliter.

16. The sensor of claim 15, wherein the sample chamber has a volume of no more than about 0.1 microliter.

17. A sensor for determining the concentration of a ketone body in a sample, the sensor comprising:

a sample chamber configured for multi-directional fill; and

a first electrode pair, wherein electrodes of the first electrode pair are spaced in a lateral direction with respect to each other in the sample chamber, and

a second electrode pair, wherein electrodes of the second electrode pair each comprise an electrode portion and a trace portion and wherein entire electrode portions of the electrodes of the second electrode pair are spaced in a longitudinal direction with respect to each other in the sample chamber,

wherein the second electrode pair is positioned in between the first electrode pair, and the first and second electrode pairs placed on a first surface within the sample chamber, the first electrode pair being a pair of indicator electrodes.

18. The sensor of claim 17, wherein the second electrode pair comprises a pair of counter electrodes, and the sensor further comprising a working electrode on a second surface within the sample chamber.

19. The sensor of claim 17, wherein the second electrode pair comprises a pair of working electrodes, and wherein the first electrode pair is a pair of co-functional indicator/counter electrodes.

20. The sensor of claim 17, wherein the second electrode pair comprises a pair of counter electrodes, and wherein the first electrode pair is a pair of co-functional indicator/working electrodes.

21. The sensor of claim 17, wherein the sensor further comprises a second substrate, a spacer between the first substrate and the second substrate, together the first substrate, second substrate and spacer defining at least a portion of the sample chamber.

22. The sensor of claim 17, wherein about 10% to about 95% of the perimeter of the sample chamber is unbounded.

23. The sensor of claim 22, wherein about 50% to about 95% of the perimeter of the sample chamber is unbounded.

24. The sensor of claim 17, wherein the sample chamber comprises at least two unbounded sides.

25. The sensor of claim 24, wherein the sample chamber comprises three unbounded sides.

26. The sensor of claim 17, wherein the sample chamber has a volume of no more than about 1 microliter.

27. The sensor of claim 26, wherein the sample chamber has a volume of no more than about 0.5 microliter.

28. The sensor of claim 27, wherein the sample chamber has a volume of no more than about 0.1 microliter.