Sensitivity calibration of in vivo sensors used to measure analyte concentration

• US 10,188,334 B2
• Filed: 10/20/2017
• Issued: 01/29/2019
• Est. Priority Date: 10/30/2012
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Budiman, Erwin Satrya, Hayter, Gary Alan
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US15/789,949
• Publication Number:
  US 20180042531A1
• Time in Patent Office: 466 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0228 using calibration standards
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Methods, devices, systems, and computer program products are provided to improve sensitivity calibration of an in vivo analyte sensor and usability of an associated analyte monitoring system. In certain embodiments, methods are provided that improve the user experience of using an analyte monitoring system. Certain embodiments of the present disclosure include features that reduce the amount of calibration or re-calibration performed by the analyte monitoring system. More specifically methods of using a suspect calibration attempt to avoid having to recalibrate by adjusting the calibration or mitigating effects of sensor signal attenuation that caused the calibration attempt to be suspect are provided. Additional features are disclosed.

Claims

1. A method, comprising:

determining a sample lot sensitivity associated with a plurality of analyte sensors in a manufacturing lot;

determining one or more sensor-specific correction factors for an analyte sensor in the manufacturing lot;

determining a sensor-specific sensitivity for the analyte sensor based on the one or more sensor-specific correction factors; and

calibrating analyte level data obtained by the analyte sensor based on the sensor-specific sensitivity.

2. The method of claim 1, wherein the sample lot sensitivity is a median sensitivity for the sensors of the manufacturing lot.

3. The method of claim 1, wherein the one or more sensor-specific correction factors are predetermined.

4. The method of claim 1, wherein the one or more sensor-specific correction factors are predetermined based on prior analyte sensor use.

5. The method of claim 1, wherein the sample lot sensitivity corresponds to a nominal sensor code sensitivity.

6. The method of claim 1, wherein the one or more sensor-specific correction factors include a correction factor dependent on a physical characteristic of the analyte sensor.

7. The method of claim 6, wherein the correction factor dependent on a physical characteristic of the sensor is further dependent on a period of time of analyte sensor use.

8. The method of claim 1, wherein each of the plurality of analyte sensors in the manufacturing lot are one of a glucose sensor or a lactate sensor.

9. The method of claim 1, further comprising determining a risk distribution for each analyte sensor in the manufacturing lot.

10. The method of claim 1, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

11. The method of claim 10, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

12. The method of claim 10, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

13. The method of claim 12, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

14. The method of claim 1, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.