Small volume test strips with large sample fill ports, supported test strips, and methods of making and using same

• US 8,357,276 B2
• Filed: 08/31/2009
• Issued: 01/22/2013
• Est. Priority Date: 08/31/2009
• 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, Karinka, Shridhara Alva, Feldman, Benjamin J.
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US12/551,316
• Publication Number:
  US 20110048940A1
• Time in Patent Office: 1,240 Days
• Field of Search: 20440301-40315, 204/409, 422/82.01, 435/4, 435/14, 435 25- 28
• US Class Current: 204/403.14
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/12 characterised by using adhesives
• CPC Class Codes: B32B 37/14 characterised by the properties of the layers
• CPC Class Codes: B32B 37/18 involving the assembly of discrete sheets or panels only
• CPC Class Codes: B32B 38/0004 Cutting, tearing or severing, e.g. bursting; Cutter details cutting in general B26D; laminating combined with punching or perforating B32B38/04; removing all or part of the layers B32B38/10; cutting in combination with laying up and registration B32B38/185 takes precedence
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• 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 156/1052 with cutting, punching, tearing or severing

Abstract

The present disclosure provides small volume analyte sensors having large sample fill ports, supported analyte sensors, analyte sensors having supported tip protrusions and methods of making and using same.

Claims

1. An analyte sensor comprising:

a sample chamber, the sample chamber comprising a sample fill port, wherein the sample chamber has a volume (V_c) in mm³, the sample fill port has an area (A_p) in mm² and A_p/V_c is greater than 0.75 mm<sup>−

1</sup>;

a first substrate having a proximal end and a distal end;

a second substrate having a proximal end and a distal end; and

at least three spacers positioned between the first substrate and the second substrate,

wherein the at least three spacers are positioned in a single plane,

wherein the first substrate, the second substrate, and the at least three spacers together define the sample chamber, the sample chamber comprising a perimeter comprising a bounded region defined by the at least three spacers and an unbounded region open to the external environment, and

wherein the unbounded region is greater in distance than the bounded region.

2. The analyte sensor of claim 1, wherein A_p/V_c is greater than 1.0 mm⁻

1.

3. The analyte sensor of claim 1, wherein A_p/V_c is greater than 1.5 mm⁻

1.

4. The analyte sensor of claim 1, wherein A_p/V_c is greater than 2.0 mm⁻

1.

5. The analyte sensor of claim 1, wherein A_p/V_c is greater than 2.5 mm⁻

1.

6. The analyte sensor of claim 1, wherein A_p/V_c is greater than 3.0 mm⁻

1.

7. The analyte sensor of claim 1, wherein V_c is less than 0.10 mm³.

8. The analyte sensor of claim 1, wherein V_c is less than 0.075 mm³.

9. The analyte sensor of claim 1, wherein V_c is less than 0.050 mm³.

10. The analyte sensor of claim 1, wherein the analyte sensor comprises a plurality of electrodes.

11. The analyte sensor of claim 10, wherein one of the plurality of electrodes comprises an analyte-responsive enzyme.

12. The analyte sensor of claim 11, wherein the analyte-responsive enzyme is a glucose-responsive enzyme or a ketone-responsive enzyme.

13. The analyte sensor of claim 1, wherein two of the at least three spacers are positioned between the proximal end of the first substrate and the proximal end of the second substrate.

14. The analyte sensor of claim 1, wherein the plurality of spacers comprises at least four spacers.

15. The analyte sensor of claim 14, wherein three of the at least four spacers are positioned between the proximal end of the first substrate and the proximal end of the second substrate.

16. The analyte sensor of claim 1, wherein the plurality of spacers comprises at least five spacers.

17. The analyte sensor of claim 16, wherein four of the at least five spacers are positioned between the proximal end of the first substrate and the proximal end of the second substrate.

18. The analyte sensor of claim 1, wherein each of the plurality of spacers is an adhesive material.

19. The analyte sensor of claim 1, wherein the analyte sensor comprises a plurality of electrodes.

20. The analyte sensor of claim 19, wherein one of the plurality of electrodes comprises an analyte-responsive enzyme.

21. The analyte sensor of claim 20, wherein the analyte-responsive enzyme is a glucose-responsive enzyme or a ketone-responsive enzyme.

22. An analyte sensor comprising:

a sample chamber, the sample chamber comprising a sample fill port, wherein the sam s le chamber has a volume (V_c) in mm³, the sample fill port has an area (A_p) in mm² and A_p/V_c is greater than 0.75 mm<sup>−

1</sup>;

a first substrate having a proximal end and a distal end, wherein the first substrate comprises a first protrusion positioned at the proximal end of the first substrate;

a second substrate having a proximal end and a distal end, wherein the second substrate comprises a second protrusion positioned at the proximal end of the second substrate; and

a plurality of spacers positioned between the first substrate and the second substrate, wherein one of the plurality of spacers is positioned between the first protrusion and the second protrusion,

wherein the plurality of spacers are positioned in a single plane,

wherein the first substrate, the second substrate, and the plurality of spacers together define the sample chamber, the sample chamber comprising a perimeter comprising a bounded region defined by the plurality of spacers and an unbounded region open to the external environment, and

wherein the unbounded region is greater in distance than the bounded region.

23. The analyte sensor of claim 22, wherein the first substrate comprises a third protrusion positioned at the proximal end of the first substrate, the second substrate comprises a fourth protrusion positioned at the proximal end of the second substrate and one of the plurality of spacers is positioned between the third protrusion and the fourth protrusion.

24. An analyte sensor comprising:

a first substrate having a proximal end and a distal end;

a second substrate having a proximal end and a distal end;

a first protrusion positioned at the proximal end of the first substrate;

a second protrusion positioned at the proximal end of the second substrate;

a plurality of spacers positioned between the first substrate and the second substrate;

wherein the plurality of spacers is positioned in a single plane;

the first substrate, the second substrate, and the plurality of spacers together define a sample chamber; and

a spacer of the plurality of spacers is positioned between the first protrusion and the second protrusion.

25. The analyte sensor of claim 24, wherein the spacer positioned between the first protrusion and the second protrusion is positioned only between the first protrusion and the second protrusion.

26. The analyte sensor of claim 24, wherein the sample chamber comprises a perimeter, the perimeter comprising a bounded region defined by the plurality of spacers and an unbounded region open to the external environment, and wherein the unbounded region is greater in length than the bounded region.

27. The analyte sensor of claim 24, wherein the first substrate comprises a third protrusion positioned at the proximal end of the first substrate, the second substrate comprises a fourth protrusion positioned at the proximal end of the second substrate and another of the plurality of spacers is positioned between the third protrusion and the fourth protrusion.

28. The analyte sensor of claim 24, wherein each of the plurality of spacers is an adhesive material.

29. The analyte sensor of claim 24, wherein the analyte sensor comprises a plurality of electrodes.

30. The analyte sensor of claim 29, wherein one of the plurality of electrodes comprises an analyte-responsive enzyme.

31. The analyte sensor of claim 30, wherein the analyte-responsive enzyme is a glucose-responsive enzyme or a ketone-responsive enzyme.

32. The analyte sensor of claim 24, wherein the sample chamber comprises a sample fill port, and wherein the sample chamber has a volume (V_c) in mm³, the sample fill port has an area (A_p) in mm² and A_p/V_c is greater than 0.75 mm⁻

1.

33. The analyte sensor of claim 32, wherein A_p/V_c is greater than 1.0 mm⁻

1.

34. The analyte sensor of claim 32, wherein A_p/V_c is greater than 1.5 mm⁻

1.

35. The analyte sensor of claim 32, wherein A_p/V_c is greater than 2.0 mm⁻

1.

36. The analyte sensor of claim 32, wherein A_p/V_c is greater than 2.5 mm⁻

1.

37. The analyte sensor of claim 32, wherein A_p/V_c is greater than 3.0 mm⁻

1.

38. The analyte sensor of claim 32, wherein V_c is less than 0.10 mm³.

39. The analyte sensor of claim 32, wherein V_c is less than 0.075 mm³.

40. The analyte sensor of claim 32, wherein V_c is less than 0.050 mm³.