Method and Apparatus for Providing Data Processing and Control in a Medical Communication System

• US 20140207400A1
• Filed: 03/24/2014
• Published: 07/24/2014
• 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
• Granted Patent: US 9,804,150 B2
• Time in Patent Office: Days
• US Class Current: 702/82
• 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 and apparatus for providing data processing and control for use in a medical communication system are provided.

Claims

1. A method, executed using one or more processors, of manufacturing analyte sensors, the method comprising:

determining a sensitivity value for each of a predetermined number of analyte sensors;

determining a sensitivity variation for the predetermined number of analyte sensors;

determining a mean sensitivity based on the sensitivity value determined for each of the predetermined number of analyte sensors when it is determined that a determined sensitivity variation does not exceed a tolerance threshold level; and

associating a sensor code with an analyte sensor batch associated with the predetermined number of analyte sensors when the mean sensitivity is within a predetermined sensitivity range.

2. The method of claim 1, wherein the sensitivity variation is determined as a coefficient of variation.

3. The method of claim 1, wherein the sensitivity value for each of the predetermined number of analyte sensors is determined in vitro.

4. The method of claim 3, wherein the in vitro determination of the sensitivity value includes measuring the sensitivity value for each of the predetermined number of analyte sensors.

5. The method of claim 4, wherein measuring the sensitivity value for each of the predetermined number of analyte sensors is performed during an analyte sensor manufacturing process.

6. The method of claim 1, wherein the sensor code is used to calibrate the predetermined number of analyte sensors associated with the analyte sensor batch associated with the predetermined number of analyte sensors.

7. The method of claim 1, wherein the sensor code is stored in an analyte monitoring device.

8. The method of claim 1, further comprising determining a response time for each of the predetermined number of analyte sensors.

9. The method of claim 8, further comprising determining a mean response time of the predetermined number of analyte sensors.

10. The method of claim 9, wherein the mean response time is used for lag correction of data obtained using analyte sensors included in the analyte sensor batch associated with the predetermined number of analyte sensors.

11. The method of claim 1, wherein each of the predetermined number of analyte sensors comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

12. The method of claim 1, wherein upon determining that the determined sensitivity variation exceeds the tolerance threshold level, rejecting the analyte sensor batch associated with the predetermined number of analyte sensors.

13. The method of claim 1, wherein determining the sensitivity value for each of the predetermined number of analyte sensors further includes determining if each of the determined sensitivity values are within a predetermined range.

14. The method of claim 13, further comprising rejecting the analyte sensor batch associated with the predetermined number of analyte sensors when a predetermined number of the determined sensitivity values are not within the predetermined range.

15. The method of claim 1, wherein determining the mean sensitivity includes determining if the determined mean sensitivity is within the predetermined sensitivity range.

16. The method of claim 15, further comprising rejecting the analyte sensor batch associated with the predetermined number of analyte sensors when the determined mean sensitivity is not within the predetermined sensitivity range.

17. The method of claim 1, further including sampling the predetermined number of analyte sensors during an analyte sensor manufacturing process.

18. The method of claim 17, wherein the sampled predetermined number of analyte sensors is a subset of the analyte sensors in the analyte sensor batch.