Analyte sensors and methods of use

• US 8,511,147 B2
• Filed: 09/12/2011
• Issued: 08/20/2013
• 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:
  US13/230,579
• Publication Number:
  US 20120125767A1
• Time in Patent Office: 708 Days
• Field of Search: 73/614.1, 738/647.3, 204/403.1, 204/403.11, 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 only two inlets, a first inlet and a second inlet, the first inlet and the second inlet defined by the first substrate, second substrate, and spacer;

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

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

a distal end having a width and a proximal end having a width, wherein the width of the distal end is less than the width of the proximal end, and the sample chamber is proximate the distal end of the sensor.

2. The sensor of claim 1, wherein the distal end of the sensor comprises:

a portion of a first side edge of the sensor;

a portion of a second side edge of the sensor; and

an end edge of the sensor, the end edge extending from the portion of the first side edge to the portion of the second side edge;

wherein the portion of the first side edge and the portion of the second side edge are recessed or reduced from a remainder of the first side edge and a remainder of the second side edge, respectively.

3. The sensor of claim 2, wherein the portion of the first side edge and the portion of the second side edge are linear.

4. The sensor of claim 2, wherein the portion of the first side edge and the portion of the second side edge are curved.

5. The sensor of claim 2, wherein the portion of the first side edge and the portion of the second side edge are tapered.

6. The sensor of claim 2, wherein one or more sections of the portion of the first side edge and the portion of the second side edge are tapered.

7. The sensor of claim 2, wherein one or more sections of the portion of the first side edge and the portion of the second side edge are parallel.

8. The sensor of claim 2, wherein the portion of the first side edge and the portion of the second side edge are non-parallel and curved.

9. The sensor of claim 2, wherein the portion of the first side edge and the portion of the second side edge are linear with a curved transition region.

10. The sensor of claim 9, wherein the portion of the first side edge and the portion of the second side edge are linearly tapered.

11. The sensor of claim 1, wherein the width of the first projection is approximately 80% of the width of the first inlet and the width of the second projection is approximately 80% of the width of the first inlet.

12. The sensor of claim 1, the width of the first projection is approximately 50% of the width of the first inlet and the width of the second projection is approximately 50% of the width of the first inlet.

13. The sensor of claim 1, wherein the first and second projections have a height of at least 0.2 mm.

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

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

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

17. The sensor of claim 1, comprising a third projection extending from a second edge of the sensor at the second inlet, wherein the third projection is defined by the first substrate, and wherein a width of the third projection is less than a width of the second inlet.

18. The sensor of claim 17, comprising a fourth projection extending from the second edge of the sensor at the second inlet, wherein the fourth projection is defined by the second substrate, and wherein a width of the fourth projection is less than a width of the second inlet.

19. The sensor of claim 1, wherein the spacer comprises a first portion and a second portion, wherein the first portion is positioned at the distal end of the sensor and the first portion is smaller than the second portion.

20. 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, the spacer comprising a first portion and a second portion,

a sample chamber having only two inlets, a first inlet and a second inlet, the first inlet and the second inlet defined by the first substrate, second substrate, the first portion of the spacer and the second portion of the spacer;

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

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

a distal end having a width and a proximal end having a width, wherein the width of the distal end is less than the width of the proximal end, and the sample chamber is proximate the distal end of the sensor.

21. The sensor of claim 20, wherein the distal end of the sensor comprises:

a portion of a first side edge of the sensor;

a portion of a second side edge of the sensor; and

an end edge of the sensor, the end edge extending from the portion of the first side edge to the portion of the second side edge;

wherein the portion of the first side edge and the portion of the second side edge are recessed from a remainder of the first side edge and a remainder of the second side edge, respectively.

22. The sensor of claim 21, wherein the portion of the first side edge and the portion of the second side edge are linear.

23. The sensor of claim 21, wherein the portion of the first side edge and the portion of the second side edge are curved.

24. The sensor of claim 21, wherein the portion of the first side edge and the portion of the second side edge are tapered.

25. The sensor of claim 21, wherein one or more sections of the portion of the first side edge and the portion of the second side edge are tapered.

26. The sensor of claim 21, wherein one or more sections of the portion of the first side edge and the portion of the second side edge are parallel.

27. The sensor of claim 21, wherein the portion of the first side edge and the portion of the second side edge are non-parallel and curved.

28. The sensor of claim 21, wherein the portion of the first side edge and the portion of the second side edge are linear with a curved transition region.

29. The sensor of claim 28, wherein the portion of the first side edge and the portion of the second side edge are linearly tapered.

30. The sensor of claim 20, wherein the width of the first projection is approximately 80% of the width of the first inlet and the width of the second projection is approximately 80% of the width of the first inlet.

31. The sensor of claim 20, wherein the width of the first projection is approximately 50% of the width of the first inlet and the width of the second projection is approximately 50% of the width of the first inlet.

32. The sensor of claim 20, wherein the first and second projections have a height of at least 0.2 mm.

33. The sensor of claim 20, wherein the sample chamber has a volume of one microliter or less.

34. The sensor of claim 20, wherein the analyte is glucose and the sample chamber comprises a glucose-responsive enzyme.

35. The sensor of claim 20, wherein the analyte is ketone and the sample chamber comprises a ketone-responsive enzyme.

36. The sensor of claim 20, comprising a third projection extending from a second edge of the sensor at the second inlet, wherein the third projection is defined by the first substrate, and wherein a width of the third projection is less than a width of the second inlet.

37. The sensor of claim 20, comprising a fourth projection extending from the second edge of the sensor at the second inlet, wherein the fourth projection is defined by the second substrate, and wherein a width of the fourth projection is less than a width of the second inlet.