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

• US 8,679,311 B2
• Filed: 01/10/2013
• Issued: 03/25/2014
• Est. Priority Date: 08/31/2009
• Status: Active Grant

• 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:
  US13/738,585
• Publication Number:
  US 20130160941A1
• Time in Patent Office: 439 Days
• Field of Search: 20440301-40315, 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. A method of making an analyte sensor having supported protrusions, the method comprising:

combining

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

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

a plurality of spacers to provide a layered structure having the plurality of spacers positioned in a plane between the first substrate and the second substrate;

removing material from the layered structure to provide an analyte sensor having a first protrusion at the proximal end of the first substrate and a second protrusion at the proximal end of the second substrate, wherein the first protrusion and the second protrusion are supported by one of the plurality of spacers, or a portion thereof, positioned between the first protrusion and the second protrusion.

2. The method of claim 1, wherein the removing further comprises removing material from the layered structure to provide a third protrusion at the proximal end of the first substrate and a fourth protrusion at the proximal end of the second substrate, wherein the third protrusion and the fourth protrusion are supported by one of the plurality of spacers, or a portion thereof, positioned between the third protrusion and the fourth protrusion.

3. The method of claim 1, wherein the removing comprises punching the layered structure to provide the analyte sensor.

4. The method of claim 1, wherein the removing comprises cutting the layered structure to provide the analyte sensor.

5. The method of claim 1, wherein each of the plurality of spacers comprises an adhesive material.

6. The method of claim 1, wherein the method further comprises depositing the plurality of spacers on the first or second substrate as a single layer.

7. The method of claim 1, wherein the plurality of spacers comprises a spacer which comprises an edge defining a repeating geometric pattern.

8. The method of claim 7, wherein the first protrusion and the second protrusion are supported by a portion of said spacer comprising an edge defining a repeating geometric pattern.

9. The method of claim 7, wherein the repeating geometric pattern is a sawtooth pattern, a wave pattern or a crenellation pattern.

10. The method of claim 1, wherein the analyte sensor comprises 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⁻

1.

11. The method of claim 10, wherein A_p/V_c is greater than 1.0 mm⁻

1.

12. The method of claim 10, wherein A_p/V_c is greater than 1.5 mm⁻

1.

13. The method of claim 10, wherein A_p/V_c is greater than 2.0 mm⁻

1.

14. The method of claim 10, wherein A_p/V_c is greater than 2.5 mm⁻

1.

15. The method of claim 10, wherein A_p/V_c is greater than 3.0 mm⁻

1.

16. The method of claim 10, wherein V_c is less than 0.10 mm³.

17. The method of claim 10, wherein V_c is less than 0.075 mm³.

18. The method of claim 10, wherein V_c is less than 0.050 mm³.

19. A method of making an analyte sensor having a plurality of proximal supports, the method comprising:

combining

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

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

a plurality of spacers to provide a layered structure having the plurality of spacers positioned in a plane between the first substrate and the second substrate;

removing material from the layered structure to provide an analyte sensor having a first portion of one of the plurality of spacers positioned between the proximal end of the first substrate and the proximal end of the second substrate, and a second portion of said one of the plurality of spacers positioned between the proximal end of the first substrate and the proximal end of the second substrate, wherein the first and second portions of said one of the plurality of spacers are not in contact.

20. The method of claim 19, wherein the removing comprises punching the layered structure to provide the analyte sensor.

21. The method of claim 19, wherein the removing comprises cutting the layered structure to provide the analyte sensor.

22. The method of claim 19, wherein each of the plurality of spacers comprises an adhesive material.

23. The method of claim 19, wherein the method further comprises depositing the plurality of spacers on the first or second substrate as a single layer.

24. The method of claim 19, wherein said one of the plurality of spacers comprises a spacer which comprises an edge defining a repeating geometric pattern.

25. The method of claim 24, wherein the repeating geometric pattern is a sawtooth pattern, a wave pattern or a crenellation pattern.

26. The method of claim 19, wherein the analyte sensor comprises 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⁻

1.

27. The method of claim 26, wherein A_p/V_c is greater than 1.0 mm⁻

1.

28. The method of claim 26, wherein A_p/V_c is greater than 1.5 mm⁻

1.

29. The method of claim 26, wherein A_p/V_c is greater than 2.0 mm⁻

1.

30. The method of claim 26, wherein A_p/V_c is greater than 2.5 mm⁻

1.

31. The method of claim 26, wherein A_p/V_c is greater than 3.0 mm⁻

1.

32. The method of claim 26, wherein V_c is less than 0.10 mm³.

33. The method of claim 26, wherein V_c is less than 0.075 mm³.

34. The method of claim 26, wherein V_c is less than 0.050 mm³.