Analyte sensors and methods of use

• US 20070203407A1
• Filed: 02/28/2006
• Published: 08/30/2007
• 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, Liu, Zenghe, Feldman, Benjamin
• Granted Patent: US 7,826,879 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 third electrode provided in electrical contact with at least one of the first or second electrodes;

wherein at least a portion of the first electrode and the second electrode are subcutaneously positioned in a patient, and further

wherein the third electrode is substantially entirely positioned external to the patient.

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

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

4. 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.

5. The system of claim 1 wherein the analyte includes one of an interstitial fluid or blood.

6. The system of claim 2 further including a second working electrode at least a portion of which is subcutaneously positioned in the patient.

7. The system of claim 1 wherein the third electrode includes an external skin contact counter electrode.

8. The system of claim 1 further including a transmitter unit configured to establish electrical contact with one or more of the first, second or third electrodes.

9. The system of claim 8 wherein the third electrode is disposed on a surface of the transmitter unit such that at least a portion of the third electrode is in physical contact with the patient'"'"'s skin and the transmitter unit.

10. The system of claim 9 further including an alarm unit, the alarm unit configured to alert the patient when the third electrode physically separates from the skin of the patient.

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

12. A method of providing an analyte sensor, comprising the steps of:

providing a substrate;

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

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

positioning a third electrode in electrical contact with the first and second electrodes, where the third electrode is substantially entirely external to the patient.

13. The method of claim 12 wherein the first electrode is a working electrode, the second electrode is a reference electrode, and the third electrode is a counter electrode.

14. The method of claim 12 wherein the first and second surfaces of the substrate are the same.

15. The method of claim 12 wherein the first surface of the substrate on the opposite side of the substrate as the second surface of the substrate.

16. The method of claim 12 wherein the analyte includes one of an interstitial fluid or blood.

17. The method of claim 13 further including the step of disposing a second working electrode on either of said first or second surface of the substrate.

18. The method of claim 17 wherein at least a portion of the second working electrode is subcutaneously positioned in the patient.

19. A system for monitoring analyte in a patient, comprising:

a sensor including a working electrode, a reference electrode, and a counter electrode, at least a portion of the sensor configured for transcutaneous placement in a patient such that the at least the portion of the sensor is in fluid contact with an analyte of the patient, and wherein the counter electrode is provided on the external surface of the patient'"'"'s skin; and

a transmitter unit operatively coupled to the sensor and configured to receive one or more signals from the sensor corresponding to an analyte level of the patient.

20. The system of claim 19 wherein the portion of the sensor in fluid contact with the patient'"'"'s analyte includes a portion of the working electrode.

21. The system of claim 19 wherein the counter electrode is positioned substantially completely external to the body of the patient, and further, wherein the counter electrode is configured for electrical communication with the transmitter unit.