Analyte sensor calibration management

• US 10,463,288 B2
• Filed: 08/11/2017
• Issued: 11/05/2019
• Est. Priority Date: 03/28/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Harper, Wesley Scott, Dunn, Timothy Christian, Budiman, Erwin Satrya, Doniger, Kenneth J., Hayter, Gary Alan
• Primary Examiner(s): Jang, Christian
• Application Number:
  US15/675,636
• Publication Number:
  US 20180000389A1
• Time in Patent Office: 816 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Methods and devices to detect analyte in body fluid are provided. Embodiments include positioning an analyte sensor in fluid contact with an analyte, detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, categorizing the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal, performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period, managing if and when to request additional reference signal measurements, and managing if and when to temporarily not display results.

Claims

1. A method, comprising:

detecting, using one or more processors, a first attenuation associated with a first early signal attenuation condition in a first analyte related signal from an analyte sensor positioned in fluid contact with bodily fluid during a predetermined time period;

categorizing, using the one or more processors, the detected first attenuation based, at least in part, on one or more characteristics of the first analyte related signal;

confirming, in response to categorizing the detected first attenuation, that a reportable data should be generated;

performing, using the one or more processors, signal processing to generate the reportable data associated with the first analyte sensor signal during the predetermined time period;

displaying, using the one or more processors, an indication of the analyte level based on the reportable data on an activated user interface;

detecting, using the one or more processors, a second attenuation associated with a second early signal attenuation condition in a second analyte related signal from the analyte sensor;

categorizing, using the one or more processors, the detected second attenuation based at least in part on one or more characteristics of the second analyte related signal, to determine a category for the detected second attenuation, the category for the detected second attenuation corresponding to an early sensitivity attenuation (ESA) severity; and

in response to the ESA severity of the category for the detected second attenuation exceeding a predetermined threshold, deactivating the user interface.

2. The method of claim 1, wherein the analyte is one of lactate or glucose.

3. The method of claim 1, wherein the indication is displayed in real time while the user interface is activated.

4. The method of claim 1, further comprising receiving, using the one or more processors, the first analyte related signal and the second analyte related signal from the analyte sensor over a wireless communication protocol, the protocol being one of:

an RF communication protocol, an infrared communication protocol, a Bluetooth enabled communication protocol, or an 802.11x wireless communication protocol.

5. The method of claim 1, further comprising storing, using the one or more processors, a schedule, and wherein the predetermined time period corresponds to a scheduled calibration time period.

6. The method of claim 5, further comprising scheduling, using the one or more processors, an additional calibration at a later time period relative to the predetermined time period.

7. The method of claim 1, further comprising determining, using the one or more processors, that a grace period has not expired, and wherein categorizing, using the one or more processors, the detected first attenuation is in response to determining that the grace period has not expired.

8. 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.

9. The method of claim 8, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

10. The method of claim 8, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

11. The method of claim 10, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

12. An apparatus, comprising:

a data communication interface;

a user interface;

one or more processors operatively coupled to the data communication interface; and

a memory storing instructions which, when executed by the one or more processors, causes the one or more processors to;

detect a first attenuation associated with a first early signal attenuation condition in a first analyte related signal from an analyte sensor positioned in fluid contact with bodily fluid during a predetermined time period;

categorize the detected first attenuation based, at least in part, on one or more characteristics of the first analyte related signal;

confirm, in response to categorizing the detected first attenuation, that a reportable data should be generated;

perform signal processing to generate the reportable data associated with the first analyte sensor signal during the predetermined time period;

display an indication of the analyte level based on the reportable data on the user interface while the user interface is activated;

detect a second attenuation associated with a second early signal attenuation condition in a second analyte related signal from the analyte sensor;

categorize the detected second attenuation based at least in part on one or more characteristics of the second analyte related signal, to determine a category for the detected second attenuation, the category for the detected second attenuation corresponding to an early sensitivity attenuation (ESA) severity; and

in response to the ESA severity of the category for the detected second attenuation exceeding a predetermined threshold, deactivating the user interface.

13. The apparatus of claim 12, wherein the analyte is one of lactate or glucose.

14. The apparatus of claim 12, further storing instructions to receive the first analyte related signal and second analyte related signal from the analyte sensor over a wireless communication protocol, the protocol being one of:

an RF communication protocol, an infrared communication protocol, a Bluetooth enabled communication protocol, or an 802.11x wireless communication protocol.

15. The apparatus of claim 12, wherein the memory stores a schedule, and wherein the predetermined time period corresponds to a scheduled calibration time period.

16. The apparatus of claim 15, further storing instructions to schedule an additional calibration at a later time period relative to the predetermined time period.

17. The apparatus of claim 12, further storing instructions to determine that a grace period has not expired, and wherein the one or more processors categorize the detected first attenuation in response to determining that the grace period has not expired.

18. The apparatus of claim 12, 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.

19. The apparatus of claim 18, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

20. The apparatus of claim 18, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.