Analyte sensors and methods of use

• US 9,844,329 B2
• Filed: 05/06/2015
• Issued: 12/19/2017
• 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 Jay
• Primary Examiner(s): Van, Luan V
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US14/705,881
• Publication Number:
  US 20150230739A1
• Time in Patent Office: 958 Days
• Field of Search: None
• 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 monitoring system, comprising:

an analyte sensor configured to monitor an analyte level in interstitial fluid under a skin surface; and

a transmitter unit operatively coupled to the analyte sensor and configured to receive one or more signals generated by the analyte sensor corresponding to the monitored analyte level, the transmitter unit including an external surface having one or more conductive points in electrical contact with the analyte sensor, wherein the one or more conductive points physically contacts the skin surface when the transmitter unit is operatively coupled to the analyte sensor.

2. The system of claim 1, wherein the one or more conductive points includes a plurality of conductive points in electrical contact with the transmitter unit, one or more of the plurality of conductive points configured to provide physical contact with the skin surface when the transmitter unit is positioned on the skin surface.

3. The system of claim 2, wherein at least one of the plurality of conductive points is in continuous physical contact with the skin surface.

4. The system of claim 2, wherein the plurality of conductive points are positioned on the external surface in a predetermined pattern.

5. The system of claim 2, wherein the analyte sensor includes a substrate and one or more of a working electrode and a reference electrode disposed on the substrate, each of the working electrode and the reference electrode electrically coupled to the transmitter unit.

6. The system of claim 1, wherein one or more conductive contacts is configured to function as a counter electrode of the analyte sensor.

7. The system of claim 6, wherein the one or more conductive contacts is in electrical contact with a temperature probe.

8. The system of claim 7, wherein the temperature probe is configured to generate one or more signals corresponding to skin temperature.

9. The system of claim of 8, wherein the transmitter unit is configured to receive the generated one or more signals corresponding to the skin temperature.

10. The system of claim 9, wherein the transmitter unit is configured to process and communicate to a remote location the one or more signals corresponding to the skin temperature and the one or more signals generated by the analyte sensor corresponding to the monitored analyte level.

11. The system of claim 8, wherein the transmitter unit is configured to adjust the one or more signals generated by the analyte sensor corresponding to the monitored analyte level using the one or more signals corresponding to the skin temperature.

12. The system of claim 1, further including an alarm unit to generate an alarm signal when the one or more conductive points are no longer in physical contact with the skin surface when the transmitter unit is operatively coupled to the analyte sensor.

13. The system of claim 12, wherein the transmitter unit includes the alarm unit and is configured to output the generated alarm signal.

14. An analyte monitoring system, comprising:

an analyte sensor configured to generate one or more signals corresponding to a monitored analyte level in interstitial fluid under a skin surface;

a transmitter unit operatively coupled to the analyte sensor and configured to receive the generated one or more signals from the analyte sensor, the transmitter unit including an external surface having one or more conductive points in electrical contact with the transmitter unit, wherein the one or more conductive points physically contacts the skin surface when the transmitter unit is operatively coupled to the analyte sensor; and

a receiver in signal communication with the transmitter unit and configured to receive data associated with the generated one or more signals corresponding to the monitored analyte level.

15. The system of claim 14, wherein the receiver is configured to process the data received from the transmitter unit.

16. The system of claim 14, wherein the receiver is configured to wirelessly receive the data from the transmitter unit.

17. The system of claim 14, wherein the one or more conductive points includes a plurality of conductive points in electrical contact with the transmitter unit, one or more of the plurality of conductive points configured to provide physical contact with the skin surface when the transmitter unit is positioned on the skin surface.

18. The system of claim 17, wherein at least one of the plurality of conductive points is in continuous physical contact with the skin surface.

19. The system of claim 17, wherein the receiver is configured to output an alarm signal when the conductive points on the external surface of the transmitter unit are no longer in physical contact with the skin surface.