Analyte sensors with a sensing surface having small sensing spots

• US 10,327,677 B2
• Filed: 12/08/2011
• Issued: 06/25/2019
• Est. Priority Date: 12/09/2010
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, Le, Phu, Wang, Yi, Fujimoto, Frank David, Qian, Suyue, Tran, Lam
• Primary Examiner(s): Messersmith, Eric J
• Application Number:
  US13/315,034
• Publication Number:
  US 20120150005A1
• Time in Patent Office: 2,756 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a sensing surface that includes two or more sensing elements disposed laterally to each other, where the sensing surface is on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Claims

1. A plurality of analyte sensors each comprising:

a working electrode comprising a conductive material disposed on a substrate;

a counter electrode;

a sensing surface disposed on the conductive material of the working electrode, the sensing surface comprising two or more discontiguous sensing elements arranged thereon,

wherein each discontiguous sensing element has an arcuate cross-sectional profile and semi-spherical shape, a diameter of 50 μ

m to 175 μ

m, a volume of 0.1 to 50 pico liters, and comprises an analyte-responsive enzyme; and

a flux limiting membrane that covers the discontiguous sensing elements and is in contact with the working electrode between each discontiguous sensing element; and

a sensor control unit comprising a processing circuit,

wherein the sensor control unit comprising a processing circuit is configured to process factory-determined calibrated measurements that are input or stored in the sensor control unit, such that the plurality of analyte sensors are thereby factory calibrated, requiring no user calibration or recalibration.

2. The plurality of analyte sensors of claim 1, wherein the discontiguous sensing elements are arranged as individual sensing elements on the working electrode.

3. The plurality of analyte sensors of claim 2, wherein the sensing surface comprises an array of two or more individual sensing elements.

4. The plurality of analyte sensors of claim 3, wherein the sensing surface comprises an array of 100 or more individual sensing elements.

5. The plurality of analyte sensors of claim 1, wherein the sensing surface has a density of discontiguous sensing elements ranging from 2-1000 sensing elements/mm².

6. The plurality of analyte sensors of claim 1, wherein the sensing surface further comprises inter-feature areas.

7. The plurality of analyte sensors of claim 6, wherein the inter-feature areas surround the discontiguous sensing elements.

8. The plurality of analyte sensors of claim 6, wherein the discontiguous sensing elements have an inter-feature distance ranging from 1 μ

m to 500 μ

m.

9. The plurality of analyte sensors of claim 6, wherein the inter-feature areas are free of the analyte-responsive enzyme.

10. The plurality of analyte sensors of claim 6, wherein the inter-feature areas are free of a redox mediator.

11. The plurality of analyte sensors of claim 1, wherein the two or more discontiguous sensing elements are a first layer, and further comprising a second layer of two or more discontiguous sensing elements disposed on first layer.

12. The plurality of analyte sensors of claim 1, wherein at least a portion of the plurality of analyte sensors is adapted to be subcutaneously positioned in a subject.

13. The plurality of analyte sensors of claim 1, wherein the analyte-responsive enzyme comprises a glucose-responsive enzyme.

14. The plurality of analyte sensors of claim 13, wherein the sensing elements comprise a redox mediator.

15. The plurality of analyte sensors of claim 14, wherein the redox mediator comprises a ruthenium-containing complex or an osmium-containing complex.

16. The plurality of analyte sensors of claim 13, wherein the plurality of analyte sensors are glucose sensors.

17. The plurality of analyte sensors of claim 13, wherein the plurality of analyte sensors are in vivo sensors.

18. The plurality of analyte sensors of claim 13, wherein the plurality of analyte sensors are in vitro sensors.

19. The plurality of analyte sensors of claim 1, wherein each discontiguous sensing element further element comprises:

a polymer; and

a redox mediator covalently bonded to the polymer.

20. The method of claim 1, wherein each discontiguous sensing element further comprises:

a polymer; and

a redox mediator.

21. The plurality of analyte sensors of claim 1, wherein the plurality of analyte sensors achieve a coefficient of variation in sensitivity of less than 20% therebetween.

22. A method comprising:

monitoring a level of an analyte with at least a portion of at least one of a plurality of analyte sensors configured to be positioned into skin of a subject, wherein the plurality of analyte sensors each comprises;

a working electrode comprising a conductive material disposed on a substrate;

a counter electrode;

a sensing surface disposed on the conductive material of the working electrode, the sensing surface comprising two or more discontiguous sensing elements arranged thereon,

wherein each discontiguous sensing element has an arcuate cross-sectional profile and semi-spherical shape, a diameter of 50 μ

m to 175 μ

m, a volume of 0.1 to 50 pico liters, and comprises an analyte-responsive enzyme; and

a flux limiting membrane that covers the discontiguous sensing elements and is in contact with the working electrode between each discontiguous sensing element; and

a sensor control unit comprising a processing circuit, wherein the sensor control unit comprising a processing circuit is configured to process factory-determined calibrated measurements that are input or stored in the sensor control unit, such that the plurality of analyte sensors are thereby factory calibrated, requiring no user calibration or recalibration; and

determining a level of an analyte over a period of time from signals generated by the analyte sensor.

23. The method of claim 22, wherein the plurality of analyte sensors achieve a coefficient of variation in sensitivity of less than 20% therebetween.

24. The method of claim 22, wherein the discontiguous sensing elements are arranged as individual sensing elements on the working electrode.

25. The method of claim 24, wherein the sensing surface comprises an array of two or more individual sensing elements.

26. The method of claim 25, wherein sensing surface comprises an array of 100 or more individual sensing elements.

27. The method of claim 22, wherein the sensing surface has a density of discontiguous sensing elements ranging from 2-1000 sensing elements/mm².

28. The method of claim 23, wherein the sensing surface further comprises inter-feature areas.

29. The method of claim 28, wherein the inter-feature areas surround the discontiguous sensing elements.

30. The method of claim 28, wherein the sensing elements have an inter-feature distance ranging from 1 μ

m to 500 μ

m.

31. The method of claim 28, wherein the inter-feature areas are free of the analyte-responsive enzyme.

32. The method of claim 28, wherein the inter-feature areas are free of a redox mediator.

33. The method of claim 22, wherein the two or more discontiguous sensing elements are a first layer, and further comprising a second layer of two or more sensing elements disposed on the first layer.

34. The method of claim 22, wherein at least a portion of at least one of the plurality of analyte sensors is adapted to be subcutaneously positioned in a subject.

35. The method of claim 22, wherein the analyte-responsive enzyme comprises a glucose-responsive enzyme.

36. The method of claim 35, wherein the discontiguous sensing elements comprise a redox mediator.

37. The method of claim 35, wherein the at least one of a plurality of analyte sensors is a glucose sensor.