ANALYTE SENSORS COMPRISING ELECTRODES HAVING SELECTED ELECTROCHEMICAL AND MECHANICAL PROPERTIES

• US 20120097554A1
• Filed: 10/18/2011
• Published: 04/26/2012
• Est. Priority Date: 10/18/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Larson, Eric Allan, Wolfe, Katherine T., Pesantez, Daniel E.
• Application Number:
  US13/276,183
• Publication Number:
  US 20120097554A1
• Time in Patent Office: Days
• US Class Current: 205/782
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Embodiments of the invention disclosed herein comprise amperometric glucose sensor systems that include multiple working electrodes having different material properties as well as algorithms and other elements designed for use with such systems. While embodiments of the innovation can be used in a number of contexts, typical embodiments of the invention include glucose sensors used to facilitate the management of diabetes.

Claims

1. An amperometric glucose sensor system comprising:

a processor;

a first working electrode comprising a first electrochemically reactive surface formed from an iridium composition, wherein the first electrochemically reactive surface generates an electrochemical signal that is assessed by the processor in the presence of glucose;

a second working electrode comprising a second electrochemically reactive surface formed from a platinum composition, wherein the second electrochemically reactive surface generates an electrochemical signal that is assessed by the processor in the presence of glucose;

a counter electrode;

a reference electrode; and

a computer-readable program code having instructions, which when executed cause the processor to;

assess electrochemical signal data obtained from the first working electrode and the second working electrode; and

compute a glucose concentration based upon the electrochemical signal data obtained from the first working electrode and/or the second working electrode.

2. The amperometric glucose sensor system of claim 1, wherein the first working electrode and the second working electrode are coated with:

a glucose oxidase layer; and

/or

an interference rejection layer; and

/or

a glucose modulating layer, wherein the glucose modulating layer comprises a composition that modulates the diffusion of glucose through the glucose modulating layer.

3. The amperometric glucose sensor system of claim 2, wherein:

the first working electrode is not coated with an interference rejection layer and the second working electrode is coated with a interference rejection layer; and

/or

the first working electrode is coated with a first glucose oxidase layer and the second working electrode is coated with a second glucose oxidase layer, wherein the amount of glucose oxidase in the first glucose oxidase layer is greater than the amount of glucose oxidase in the second glucose oxidase layer; and

/or

the first working electrode is coated with a first glucose modulating layer having a first rate of glucose diffusion and the second working electrode is coated with a second glucose modulating layer having a second rate of glucose diffusion, wherein the first rate of glucose diffusion is less than the second rate of glucose diffusion.

4. The amperometric glucose sensor system of claim 1, wherein:

the first electrochemically reactive surface comprises iridium oxide; and

/or

the second electrochemically reactive surface comprises platinum black.

5. The amperometric glucose sensor system of claim 1, wherein the first working electrode exhibits an electrochemically reactive surface area that is at least 25% greater than a geometrical surface area of the electrochemically reactive surface.

6. The amperometric glucose sensor system of claim 1, wherein the first and/or second working electrodes are formed from a cylindrical wire having a diameter less than 0.0015 inches.

7. The amperometric glucose sensor system of claim 1, wherein the processor evaluates data resulting from a plurality of different voltages applied to the system.

8. The amperometric glucose sensor system of claim 7, wherein:

the processor evaluates data resulting from a plurality different voltage pulses applied to the first working electrode and second working electrode; and

the data evaluated results from;

a voltage potential of between 0.2 and 0.6 volts applied to the first working electrode; and

a voltage potential of between 0.5 and 0.7 volts applied to the second working electrode.

9. The amperometric glucose sensor system of claim 1, wherein the processor compares the electrochemical signal data from the first working electrode and the second working electrode and the comparison includes:

observing whether a signal obtained from the first working electrode and the second working electrode falls within a predetermined range of values;

observing a trend in sensor signal data from the first working electrode and the second working electrode;

or

observing an amount of nonspecific signal noise in the first working electrode and the second working electrode.

10. The amperometric glucose sensor system of claim 1, wherein the processor:

assesses electrochemical signal data obtained from the first working electrode and the second working against one or more reliability parameters;

ranks electrochemical signal data obtained from the first working electrode and the second working electrode; and

computes glucose concentration based upon the ranking of electrochemical signal data obtained from the first working electrode and the second working electrode.

11. The amperometric glucose sensor system of claim 1, wherein the system further comprises:

a first probe adapted to be inserted in vivo, wherein the first probe includes a first electrode array comprising the first working electrode and the second working electrode;

a probe platform coupled to the first probe;

a second probe coupled to the probe platform and adapted to be inserted in vivo, wherein the second probe comprises a second electrode array comprising;

a third working electrode comprising a third electrochemically reactive surface formed from an iridium composition, wherein the third electrochemically reactive surface generates an electrochemical signal that is observed by the processor in the presence of glucose;

a fourth working electrode comprising a fourth electrochemically reactive surface formed from a platinum composition, wherein the fourth electrochemically reactive surface generates an electrochemical signal that is observed by the processor in the presence of glucose; and

a computer-readable program code having instructions, which when executed cause the processor to;

assess electrochemical signal data obtained from the first and second electrode arrays; and

compute a glucose concentration based upon the electrochemical signal data obtained from the first and second electrode arrays.

12. The amperometric glucose sensor system of claim 11, wherein:

electrochemical signal data obtained from the first working electrode and the second working electrode is weighted according to one or more reliability parameters and the weighted electrochemical signal data is fused to compute a glucose concentration; and

/or

electrochemical signal data obtained from the first and second electrode arrays is weighted according to one or more reliability parameters and the weighted electrochemical signal data is fused to compute a glucose concentration.

13. The amperometric glucose sensor system of claim 11, wherein:

the first and second probes are oriented on the probe platform so that the first and second electrode arrays are located at different depths when inserted into an in vivo environment; and

/or

the first probe and second probes are coupled to the probe platform and the probe platform is made from a flexible material that allows the probes to twist and bend when implanted in vivo in a manner that inhibits in vivo movement of the probes.

14. The amperometric glucose sensor system of claim 11, wherein the system further comprises an adhesive patch adapted to secure the probe platform to skin of a diabetic patient

15. A method for computing a blood glucose concentration in a diabetic patient, the method comprising:

observing electrochemical signal data generated by a sensor system comprising;

a processor;

a first working electrode comprising a first electrochemically reactive surface formed from an iridium composition, wherein the first electrochemically reactive surface generates an electrochemical signal that is assessed by the processor in the presence of glucose;

a second working electrode comprising a second electrochemically reactive surface formed from a platinum composition, wherein the second electrochemically reactive surface generates an electrochemical signal that is assessed by the processor in the presence of glucose;

a counter electrode;

a reference electrode; and

a computer-readable program code having instructions, which when executed cause the processor to;

assess electrochemical signal data obtained from the first working electrode and the second working electrode; and

compute a glucose concentration based upon the electrochemical signal data obtained from the first working electrode and the second working electrode;

wherein the first working electrode and second working electrode are configured to be electronically independent of one another; and

the method further comprises;

comparing the electrochemical signal data from the first working electrode and the second working electrode; and

computing a blood glucose concentration using the comparison of the electrochemical signal data obtained from the first working electrode and the second working electrode.

16. The method of claim 15, wherein the comparison of electrochemical signal data from the first working electrode and the second working electrode includes:

observing whether a signal obtained from the first working electrode and the second working electrode falls within a predetermined range of values;

observing a trend in sensor signal data from the first working electrode and the second working electrode;

or

observing an amount of nonspecific signal noise in the first working electrode and the second working electrode.

17. The method of claim 15, wherein the comparison of electrochemical signal data from the first working electrode and the second working electrode is used to identify one or more signals that is:

indicative of increasing glucose blood concentrations or decreasing blood glucose concentrations in the diabetic patient;

indicative of a presence of interfering compounds;

indicative of background noise;

indicative of sensor hydration;

indicative of sensor signal drift; and

/or

indicative of sensor loss of sensitivity to glucose.

18. The method of claim 15, further comprising using a monitor adapted to display discreet signal information from the first working electrode and/or the second working electrode.

19. A composition of matter comprising:

an iridium composition having an electrochemically reactive surface;

a glucose oxidase composition disposed upon the electrochemically reactive surface;

an analyte modulating layer disposed upon the glucose oxidase composition, wherein the analyte modulating layer comprises;

a linear polyurethane/polyurea polymer;

a branched acrylate polymer;

or

a blended mixture of the linear polyurethane/polyurea polymer and the branched acrylate polymer, wherein the mixture is blended at a ratio of between 1;

1 and 1;

20 by weight percentage.

20. The composition of claim 19, wherein:

(1) the linear polyurethane/polyurea polymer is formed from a mixture comprising;

(a) a diisocyanate;

(b) at least one hydrophilic diol or hydrophilic diamine; and

(c) a siloxane; and

/or

(2) the branched acrylate polymer is formed from a mixture comprising;

(a) a 2-(dimethylamino)ethyl methacrylate;

(b) a methyl methacrylate;

(c) a polydimethyl siloxane monomethacryloxypropyl; and

(d) a poly(ethylene oxide) methyl ether methacrylate.