Analyte sensors and methods of use

• US 7,826,879 B2
• Filed: 02/28/2006
• Issued: 11/02/2010
• Est. Priority Date: 02/28/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, Feldman, Benjamin J., Liu, Zenghe
• Primary Examiner(s): Neckel; Alexa D
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US11/365,169
• Publication Number:
  US 20070203407A1
• Time in Patent Office: 1,708 Days
• Field of Search: 600300-301, 600306-309, 600345-365, 600/372, 600385-390, 600/346, 604174-180, 128897-898, 128/903, 128/904, 128/920, 204/403, 204/406, 204/408, 204/412, 204/403.01, 204/403.14, 205/779
• US Class Current: 600/347
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/4035 Combination of a single ion-sensing electrode and a single reference electrode G01N27/406 and G01N27/413 take precedence

Abstract

An analyte sensor system including a substrate, a first electrode disposed on a first surface of the substrate, a second electrode disposed on a second surface of the substrate, a third electrode provided in electrical contact with at least one of the first or second electrodes, where at least a portion of the first electrode and the second electrode are subcutaneously positioned in a patient, and where the third electrode is substantially entirely positioned external to the patient, and corresponding methods are provided.

Claims

1. An analyte sensor system, comprising:

a substrate;

a first electrode disposed on a first surface of the substrate;

a second electrode disposed on a second surface of the substrate; and

a transmitter unit configured for electrical communication with one or more of the first and second electrodes, and including a housing having a plurality of electrical contacts disposed thereon and configured for physical contact with a skin surface;

wherein the plurality of electrical contacts are electrically coupled such that when the transmitter is positioned on the skin surface, one or more of the plurality of electrical contacts provide continuous electrical contact between the transmitter and the skin surface during a time period when at least a portion of the first electrode and the second electrodes are subcutaneously positioned under the skin surface.

2. The system of claim 1 wherein the first and second surfaces of the substrate are the same.

3. The system of claim 1 wherein the first surface of the substrate on the opposite side of the substrate as the second surface of the substrate.

4. The system of claim 1 wherein the analyte sensor includes a glucose sensor.

5. The system of claim 1 wherein the plurality of electrical contacts are coupled to a counter electrode contact of the transmitter unit.

6. The system of claim 1 wherein the plurality of electrical contacts are electrically coupled to each other such that when the transmitter unit is positioned on the skin surface, one or more of the plurality of electrical contacts provide continuous electrical contact between the skin surface and the transmitter unit.

7. The system of claim 1 wherein the time period includes one of approximately, three days, five days or seven days.

8. The system of claim 1 wherein the first electrode is a working electrode, and the second electrode is a reference electrode.

9. The system of claim 8 further including a second working electrode at least a portion of which is subcutaneously positionable in the patient.

10. The system of claim 1 further including an alarm unit, the alarm unit configured to alert the patient only when all of the plurality of the electrical contacts are no longer in physical contact with the skin surface at the same time.

11. The system of claim 10 wherein the alarm unit is integrated in the transmitter unit.

12. The system of claim 1 wherein the plurality of electrical contacts are disposed on the surface of the transmitter unit housing in a predetermined position.

13. The system of claim 12 wherein the predetermined position includes one or more of a concentric pattern or a circular pattern.

14. A method, comprising:

subcutaneously positioning at least a portion of an analyte sensor including a first electrode disposed on a first surface of a substrate and a second electrode disposed on a second surface of the substrate such that the portion of the analyte sensor is in fluid contact with an analyte under a skin surface; and

positioning a transmitter unit including a housing on the skin surface such that the transmitter unit is in electrical contact with the analyte sensor, the transmitter unit housing including a plurality of electrical contacts configured for contacting the skin surface, wherein at least one of the plurality of electrical contacts is in physical contact with the skin surface;

wherein the plurality of electrical contacts are electrically coupled and provide continuous electrical contact with the skin surface during a time period when the analyte sensor is in fluid contact with an interstitial fluid.

15. The method of claim 14 wherein the first and second surfaces of the substrate are the same.

16. The method of claim 14 wherein the first surface of the substrate on the opposite side of the substrate as the second surface of the substrate.

17. The method of claim 14 wherein the analyte sensor includes a glucose sensor.

18. The method of claim 14 including electrically coupling the plurality of electrical contacts to a counter electrode contact on the transmitter unit.

19. The method of claim 14 including coupling the plurality of electrical contacts to a common contact point such that when the transmitter is positioned on the skin surface, one or more of the plurality of electrical contacts provide continuous electrical contact between the skin surface and the transmitter unit.

20. The method of claim 14 wherein the first electrode is a working electrode and the second electrode is a reference electrode.

21. The method of claim 20 further including the step of disposing a second working electrode on either of said first or second surface of the substrate.

22. The method of claim 21 wherein at least a portion of the second working electrode is subcutaneously positioned under the skin surface.

23. The method of claim 14 wherein the plurality of electrical contacts are positioned on the surface of the transmitter housing in a predetermined pattern.

24. The method of claim 23 wherein the predetermined pattern includes one or more of a concentric pattern or a circular pattern.