Analyte sensors and methods of use

• US 8,033,162 B2
• Filed: 05/08/2009
• Issued: 10/11/2011
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi
• Primary Examiner(s): LARKIN, DANIEL SEAN
• Application Number:
  US12/463,194
• Publication Number:
  US 20090211344A1
• Time in Patent Office: 886 Days
• Field of Search: 73/614.1, 738/647.3, 204/403.1, 204/403.2, 422/68.1
• US Class Current: 73/61.41
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• 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 27/416 Systems G01N27/27 takes precedence
• CPC Class Codes: Y10T 156/1082 Partial cutting bonded sandwich [e.g., grooving or incising]

Abstract

Analyte sensors for determining the concentration of an analyte in a sample. The sensors have a sample chamber having an inlet with a projection extending from an edge of the sensor for facilitating flow of sample into the sample chamber.

Claims

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

a first substrate and a second substrate;

a spacer between the first substrate and the second substrate;

a sample chamber having a first inlet and a second inlet, the first inlet and the second inlet defined by the first substrate, second substrate, and spacer; and

a first projection extending from a first edge of the sensor proximate the first inlet, wherein the first projection is defined by the first substrate, and wherein a width of the first projection is less than a width of the inlet.

2. The sensor of claim 1, wherein the width of the projection is 80% or less than the width of the inlet.

3. The sensor of claim 1, the width of the projection is approximately 50% of the width of the inlet.

4. The sensor of claim 1, wherein the projection has a height of at least 0.2 mm.

5. The sensor of claim 1, wherein the projection extends from a side edge of the sensor.

6. The sensor of claim 1, wherein the sample chamber has a volume of one microliter or less.

7. The sensor of claim 1, wherein the analyte is glucose and the sample chamber comprises a glucose-responsive enzyme.

8. The sensor of claim 1, wherein the analyte is ketone and the sample chamber comprises a ketone-responsive enzyme.

9. The sensor of claim 1, comprising:

a second projection extending from the first edge of the sensor proximate the first inlet, wherein the second projection is defined by the second substrate, and wherein a width of the second projection is less than a width of the inlet.

10. The sensor of claim 1, comprising:

a second projection extending from a second edge of the sensor proximate the second inlet, wherein the second projection is defined by the first substrate, and wherein a width of the second projection is less than a width of the inlet.

11. The sensor of claim 1, comprising:

a second projection extending from a second edge of the sensor proximate the second inlet, wherein the second projection is defined by the second substrate, and wherein a width of the second projection is less than a width of the inlet.

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

a first substrate and a second substrate;

a spacer between the first substrate and the second substrate; and

a sample chamber between the first substrate and the second substrate, wherein the sample chamber is bounded by the spacer, and wherein the sample chamber includes a first inlet and a second inlet;

a first projection extending from the first substrate at the first inlet; and

a second projection extending from the first substrate at the second inlet.

13. The sensor of claim 12, comprising:

a third projection extending from the second substrate at the first inlet.

14. The sensor of claim 13, comprising:

a fourth projection extending from the second substrate at the second inlet.

15. The sensor of claim 12, wherein the analyte is glucose and the sample chamber comprises a glucose-responsive enzyme.

16. The sensor of claim 12, wherein the analyte is ketone and the sample chamber comprises a ketone-responsive enzyme.

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

a first substrate and a second substrate;

a first side edge, a second side edge and an end edge;

a sample chamber defined between the first substrate and the second substrate, the sample chamber extending from the first side edge to the second side edge;

a first aperture between the first substrate and the second substrate at the first side edge;

a second aperture between the first substrate and the second substrate at the second side edge; and

a first projection extending from the first side edge proximate the first aperture.

18. The sensor of claim 17, comprising:

a second projection extending from the second side edge proximate the second aperture.

19. The sensor of claim 18, comprising:

a third projection extending from the first side edge proximate the first aperture; and

a fourth projection extending from the second side edge proximate the second aperture.

20. The sensor of claim 19, wherein a width of the first projection is less than a width of the first aperture;

a width of the second projection is less than a width of the second aperture;

a width of the third projection is less than the width of the first aperture; and

a width of the fourth projection is less than the width of the second aperture.

21. The sensor of claim 19, wherein a width of the first projection is 80% or less than a width of the first aperture;

a width of the second projection is 80% or less than a width of the second aperture;

a width of the third projection is 80% or less than the width of the first aperture; and

a width of the fourth projection is 80% or less than the width of the second aperture.

22. The sensor of claim 19, wherein each of the first projection, second projection, third projection, and fourth projection have a height of at least 0.2 mm.

23. The sensor of claim 19, wherein the first projection, second projection, third projection, and fourth projection are triangles extending from the substrates.

24. The sensor of claim 17, wherein the analyte is glucose and the sample chamber comprises a glucose-responsive enzyme.

25. The sensor of claim 17, wherein the analyte is ketone and the sample chamber comprises a ketone-responsive enzyme.

26. A method of analyzing an analyte concentration in a sample, comprising:

contacting a sample with a sensor, the sensor comprising;

a first substrate and a second substrate;

a spacer between the first substrate and the second substrate;

a sample chamber between the first substrate and the second substrate, wherein the sample chamber is bounded by the spacer, and wherein the sample chamber includes a first inlet and a second inlet;

a first projection extending from the first substrate at the first inlet; and

a second projection extending from the first substrate at the second inlet;

transferring the sample into the sample chamber through the first inlet, wherein the first inlet is bounded by the first substrate, the second substrate, and the first projection; and

determining the concentration of the analyte in the sample.

27. The method of claim 26, wherein the first inlet is also bounded by a third projection.

28. The method of claim 26, wherein the determining of the concentration of the analyte in the sample comprises employing one of coulometry, amperometry and potentiometry.

29. The method according to claim 28, wherein the determining of the concentration of the analyte in the sample comprises employing coulometry.

30. The method of claim 26, wherein the transferring of the sample into the sample chamber comprises transferring 1 μ

L or less of the sample into the sample chamber.

31. The method according to claim 26, wherein the transferring of the sample into the sample chamber comprises transferring 0.5 μ

L or less of the sample into the sample chamber.

32. The sensor of claim 26, wherein the analyte is glucose and the sample chamber comprises a glucose-responsive enzyme.

33. The sensor of claim 26, wherein the analyte is ketone and the sample chamber comprises a ketone-responsive enzyme.

34. A method of analyzing an analyte concentration in a sample, comprising:

contacting a sample with a sensor, the sensor comprising;

a first substrate and a second substrate;

a spacer between the first substrate and the second substrate;

a sample chamber having a first inlet and a second inlet, the first inlet and the second inlet defined by the first substrate, second substrate, and spacer; and

a first projection extending from a first edge of the sensor proximate the first inlet, wherein the first projection is defined by the first substrate, and wherein a width of the first projection is less than a width of the inlet;

transferring the sample into the sample chamber through the first inlet, wherein the first inlet is bounded by the first substrate, the second substrate, and the first projection; and

determining the concentration of the analyte in the sample.

35. The method of claim 34, wherein the sensor comprises a second projection extending from the first edge of the sensor proximate the first inlet, wherein the second projection is defined by the second substrate, and wherein a width of the second projection is less than a width of the inlet.

36. The method of claim 34, wherein the determining of the concentration of the analyte in the sample comprises employing one of coulometry, amperometry and potentiometry.

37. The method according to claim 36, wherein the determining of the concentration of the analyte in the sample comprises employing coulometry.

38. The method of claim 34, wherein the transferring of the sample into the sample chamber comprises transferring 1 μ

L or less of the sample into the sample chamber.

39. The method according to claim 34, wherein the transferring of the sample into the sample chamber comprises transferring 0.5 μ

L or less of the sample into the sample chamber.

40. The sensor of claim 34, wherein the analyte is glucose and the sample chamber comprises a glucose-responsive enzyme.

41. The sensor of claim 34, wherein the analyte is ketone and the sample chamber comprises a ketone-responsive enzyme.