Method and apparatus for providing data processing and control in a medical communication system

• US 10,634,662 B2
• Filed: 11/05/2018
• Issued: 04/28/2020
• Est. Priority Date: 05/14/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary Alan, McGarraugh, Geoffrey V., Naegeli, Andrew H., Mazza, John Charles, Feldman, Benjamin Jay
• Primary Examiner(s): Charioui, Mohamed
• Application Number:
  US16/181,069
• Publication Number:
  US 20190072538A1
• Time in Patent Office: 540 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

Methods for data processing and control for a medical communication system are provided, including determining a sensitivity value for each sensor of a batch of in vivo analyte sensors; determining a sensitivity variation for each sensor of the batch; determining a mean sensitivity based on the sensitivity value determined for each sensor of the batch when it is determined that the determined sensitivity variation does not exceed a tolerance threshold level; associating a sensor code with each sensor of the batch of in vivo analyte sensors when the mean sensitivity is within a predetermined sensitivity range, wherein the sensor code associated with each sensor is based on a characteristic of the associated sensor; and storing the sensor code associated with at least one sensor of the batch configured to generate signals corresponding to monitored analyte level in a memory of a data processing device associated with the sensor.

Claims

1. A method, comprising:

determining a sensitivity value for one or more sensors of a batch of in vivo analyte sensors;

determining a sensitivity variation for the one or more sensors of the batch of in vivo analyte sensors;

determining a batch sensitivity for the batch of in vivo analyte sensors when it is determined that each of the determined sensitivity variations do not exceed a threshold level, by discarding one or more of the determined sensitivity values for the one or more sensors of the batch of in vivo analyte sensors;

associating a sensor code with the one or more sensors of the batch of in vivo analyte sensors, wherein the sensor code associated with each particular sensor of the one or more sensors of the batch of in vivo analyte sensors is based on a characteristic specific to the particular sensor; and

labeling a packaging for the at least one sensor of the one or more sensors of the batch of in vivo analyte sensors with the sensor code.

2. The method of claim 1, wherein discarding one or more of the determined sensitivity values for the one or more sensors of the batch of in vivo analyte sensors comprises removing one or more outlier sensitivity values, and wherein determining the batch sensitivity is not based on the one or more outlier sensitivity values.

3. The method of claim 2, wherein removing one or more outlier sensitivity values comprises repeatedly removing outlier sensitivity values.

4. The method of claim 3, wherein the sensor code is further based on a sensitivity range associated with the batch sensitivity.

5. The method of claim 1, wherein each sensor of the batch of in vivo analyte sensors comprises a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

6. The method of claim 5, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

7. The method of claim 5, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

8. The method of claim 7, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

9. The method of claim 1, wherein each sensor of the batch of in vivo analyte sensors comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

10. A method, comprising:

determining a sensitivity value for one or more sensors of a batch of in vivo analyte sensors;

determining a sensitivity variation for the one or more sensors of the batch of in vivo analyte sensors;

determining a nominal sensitivity for the batch of in vivo analyte sensors when it is determined that each of the determined sensitivity variations do not exceed a threshold level;

associating a sensor code with the one or more sensors of the batch of in vivo analyte sensors, wherein the sensor code associated with each particular sensor of the one or more sensors of the batch of in vivo analyte sensors is based on a characteristic specific to the particular sensor; and

labeling a packaging for the at least one sensor of the one or more sensors of the batch of in vivo analyte sensors with the sensor code.

11. The method of claim 10, wherein the analyte of the batch of in vivo analyte sensors is one of glucose or lactate.

12. The method of claim 10, wherein the sensor code is further based on a sensitivity range associated with the nominal sensitivity.

13. The method of claim 12, wherein the nominal sensitivity is based on the sensitivity value of a first set of one or more sensors of the batch of in vivo analyte sensors, and wherein determining the nominal sensitivity comprises discarding one or more of sensitivity values of a second set of one or more sensors of the batch of in vivo analyte sensors.

14. The method of claim 10, wherein each sensor of the batch of in vivo analyte sensors comprises a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

15. The method of claim 14, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

16. The method of claim 14, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

17. The method of claim 16, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

18. The method of claim 10, wherein each sensor of the batch of in vivo analyte sensors comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.