IMPLANTABLE ELECTRODE SYSTEM, METHOD AND APPARATUS FOR MEASURING AN ANALYTE CONCENTRATION IN A HUMAN OR ANIMAL BODY

• US 20070151868A1
• Filed: 11/12/2006
• Published: 07/05/2007
• Est. Priority Date: 11/12/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Staib, Arnulf, Gillen, Ralph
• Application Number:
  US11/558,933
• Publication Number:
  US 20070151868A1
• Time in Patent Office: Days
• US Class Current: 205/792
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

An electrode system for determining an analyte concentration in a human or animal may comprise first and second electrodes. The first electrode may be configured to produce a first signal from which the analyte concentration can be determined, and may have a first measuring sensitivity that is optimized for a first analyte concentration range. The second electrode may be configured to produce a second signal from which the analyte concentration can be determined, and may have a second measuring sensitivity that is optimized for a second analyte concentration range that is different from the first analyte concentration range. An analytical unit may be configured to determine the analyte concentration based on the first signal if the analyte concentration falls within the first analyte concentration range, and to determine the analyte concentration based on the second signal if the analyte concentration falls within the second analyte concentration range.

Claims

1-13. -13. (canceled)

14. An electrode system for determining an analyte concentration in a human or animal, comprising:

a first electrode configured to produce a first signal from which the analyte concentration can be determined, the first electrode having a first measuring sensitivity that is optimized for a first analyte concentration range, and

a second electrode configured to produce a second signal from which the analyte concentration can be determined, the second electrode having a second measuring sensitivity that is optimized for a second analyte concentration range that is different from the first analyte concentration range.

15. The electrode system of claim 14 wherein the first and second electrodes are configured such that the first and second concentration ranges do not overlap.

16. The electrode system of claim 14 wherein the first and second electrodes are configured such that the first and second concentration ranges overlap.

17. The electrode system of claim 14 wherein the first and second electrodes are configured such that the first and second measuring sensitivities differ at a reference concentration by at least a factor of 2.

18. The electrode system of claim 14 wherein the first and second electrodes each comprise an enzyme layer having an enzyme that generates, by catalytic conversion of the analyte, charge carriers that are captured for generating the first and second signals.

19. The electrode system of claim 18 wherein the enzyme layer comprising the first electrode is a different enzyme layer than the enzyme layer comprising the second electrode.

20. The electrode system of claim 18 wherein the enzyme layer comprising one of the first and second electrodes is provided in a different quantity than the enzyme layer comprising the other of the first and second electrodes.

21. The electrode system of claim 14 wherein one of the first and second electrodes comprises a covering layer that produces a diffusion resistance for the analyte,

and wherein a difference in the first and second measuring sensitivities results from the covering layer comprising the one of the first and second electrodes.

22. The electrode system of claim 14 further comprising a counter electrode that is common to the first and second electrodes.

23. The electrode system of claim 14 further comprising a third electrode configured to produce a third signal from which the analyte concentration can be determined, the third electrode having a third measuring sensitivity that is optimized for a third analyte concentration range that is different from the first and second analyte concentration ranges.

24. The electrode system of claim 14 further comprising an analytical unit configured to analyze the first and second signals to determine whether the analyte concentration falls within the first analyte concentration range or the second analyte concentration range.

25. The electrode system of claim 24 wherein the analytical unit is configured to determine the analyte concentration based on the first signal if the analyte concentration falls within the first analyte concentration range, and to determine the analyte concentration based on the second signal if the analyte concentration falls within the second analyte concentration range.

26. The electrode system of claim 24 wherein the first and second analyte concentrations overlap in an area of overlap,

and wherein the analytical unit is configured to determine the analyte concentration in the area of overlap based on a statistical analysis of a first analyte concentration determined from the first signal and a second analyte concentration determined from the second signal.

27. The electrode system of claim 14 further comprising:

an analytical unit configured to receive the first and second signals, and

a memory in which at least one first sensitivity parameter defining the first measuring sensitivity and at least one second sensitivity parameter defining the second measuring sensitivity are stored,

wherein the analytical unit is configured to determine from at least one of the first and second signals whether the analyte concentration belongs in the first or the second analyte concentration range,

and wherein the analytical unit is configured to determine the analyte concentration based on the first signal and the at least one first sensitivity parameter if the analyte concentration belongs in the first analyte concentration range, and based on the second signal and the at least one second sensitivity parameter if the analyte concentration belongs in the second analyte concentration range.

28. The electrode system of claim 27 wherein the first and second analyte concentration ranges overlap in an area of overlap,

and wherein the analytical unit is configured to determine the analyte concentration in the area of overlap based on a statistical analysis of a first analyte concentration determined from the first signal and the at least one first sensitivity parameter and a second analyte concentration determined from the second signal and the at least one second sensitivity parameter.

29. The electrode system of claim 27 further comprising:

a first potentiostat electrically connected between the first electrode and the analytical unit, and

a second potentiostat electrically connected between the second electrode and the analytical unit.

30. The electrode system of claim 29 wherein the analytical unit comprises a processor configured to separately control each of the first and second potentiostats to selectively apply and remove measuring voltages to each of the first and second electrodes,

and wherein the analytical unit is configured to compensate numerically for a local decrease in the analyte concentration resulting from a measuring current for at least one of the first and second electrodes after applying the measuring voltage to the at least one of the first and second electrodes.

31. A method for determining analyte concentration in a human or animal, the method comprising:

receiving a first measurement signal from a first implanted electrode that is optimized to produce first measurement signals over a first analyte concentration range,

receiving a second measurement signal from a second implanted electrode that is optimized to produce second measurement signals over a second analyte concentration range that is different from the first analyte concentration range, and

processing at least one of the first and second measurement signals to determine the analyte concentration.

32. The method of claim 31 wherein processing at least one of the first and second measurement signals comprises:

processing at least one of the first and second measurement signals to determine whether the analyte concentration falls within the first or second analyte concentration range,

determining the analyte concentration based on the first measurement signal if the analyte concentration falls within the first analyte concentration range, and

determining the analyte concentration based on the second measurement signal if the analyte concentration falls within the second analyte concentration range.

33. The method of claim 31 wherein processing at least one of the first and second measurement signals comprises,

processing at least one of the first and second measurement signals to determine whether the analyte concentration falls within an overlap area defined between the first and second analyte concentration ranges,

if the analyte concentration falls within the overlap area, determining a first analyte concentration based on the first measurement signal, determining a second analyte concentration based on the second measurement signal and determining the analyte concentration based on a statistical analysis of the first and second analyte concentrations.

34. The method of claim 31 wherein the first and second analyte concentrations ranges overlap.

35. The method of claim 31 wherein the first and second analyte concentration ranges do not overlap.

36. The method of claim 31 wherein the first implanted electrode has a first measuring sensitivity that is optimized to produce the first measurement signals over the first analyte concentration range,

and wherein the second implanted electrode has a second measuring sensitivity that is optimized to produce the second measurement signals over the second analyte concentration range,

and wherein the first and second sensitivities differ by at least a factor of 2.

37. The method of claim 31 further comprising receiving a third measurement signal from a third implanted electrode that is optimized to produce third measurement signals over a third range of analyte concentrations that is different from the first and second analyte concentration ranges, and

and wherein processing at least one of the first and second measurement signals comprises processing at least one of the first, second and third measurement signals to determine the analyte concentration.