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

• US 10,031,002 B2
• Filed: 12/02/2013
• Issued: 07/24/2018
• 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): Weare, Meredith
• Application Number:
  US14/094,721
• Publication Number:
  US 20140088908A1
• Time in Patent Office: 1,695 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• 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: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G01D 18/008 with calibration coefficients stored in memory
• CPC Class Codes: G01N 33/48 Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Claims

1. A method, comprising:

determining, using one or more processors, a sensitivity value associated with an analyte sensor;

retrieving, from a memory, two stored sensitivity values associated with the analyte sensor, the two stored sensitivity values being previously successively stored;

comparing the determined sensitivity value to the retrieved sensitivity values to determine whether the determined sensitivity value is within a predetermined range from either of the retrieved sensitivity values;

determining, based on the comparison of the determined sensitivity value to the retrieved sensitivity values, that the determined sensitivity value is within the predetermined range from a first retrieved sensitivity value of the retrieved sensitivity values;

determining, using the one or more processors, a composite sensitivity for the analyte sensor based on the determined sensitivity value and the first retrieved sensitivity value; and

updating buffered data based on the composite sensitivity by at least updating a value of the buffered data, the value corresponding to an analyte level measured by the analyte sensor.

2. The method of claim 1, wherein the first retrieved sensitivity value is associated with a prior calibration parameter used to calibrate the analyte sensor.

3. The method of claim 2, wherein the prior calibration parameter includes a blood glucose value.

4. The method of claim 1, wherein determining the composite sensitivity includes applying a first weighted parameter to the determined sensitivity value and applying a second weighted parameter to the first retrieved sensitivity value.

5. The method of claim 4, wherein the first weighted parameter and the second weighted parameter are different.

6. The method of claim 4, wherein the first weighted parameter and the second weighted parameter are the same.

7. The method of claim 4, wherein the first weighted parameter and the second weighted parameter are time based.

8. The method of claim 7, wherein the first retrieved sensitivity value associated with the analyte sensor is based on a prior calibration parameter used to calibrate the analyte sensor prior to a predetermined time period of receiving the prior calibration parameter.

9. The method of claim 7, wherein the first weighted parameter is associated with a current calibration event and the second weighted parameter is associated with a prior calibration event.

10. The method of claim 1, wherein the analyte sensor comprises at least one working electrode including an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

11. The method of claim 10, wherein the analyte sensor further comprises a mediator crosslinked with the polymer.

12. The method of claim 1, wherein the determined composite sensitivity is a first composite sensitivity, and wherein the two stored sensitivity values are a first set of previously successively stored sensitivity values, and further comprising:

providing a calibration schedule, the calibration schedule providing for a plurality of calibration events having corresponding times, wherein the analyte sensor is calibrated during each calibration event;

calibrating the analyte sensor according to the calibration schedule;

subsequent to the updating the buffered data, determining a subsequent second composite sensitivity value associated with the analyte sensor;

retrieving, from the memory, a second set of two previously successively stored sensitivity values associated with the analyte sensor;

comparing the determined subsequent second composite sensitivity value to the retrieved second set of two previously successively stored sensitivity values to determine whether the determined subsequent second composite sensitivity value is within the predetermined range from either of the retrieved second set of two previously successively stored sensitivity values;

determining, based on the comparison of the determined subsequent second composite sensitivity value to the retrieved second set of two previously successively stored sensitivity values, that the determined subsequent second composite sensitivity value is not within the predetermined range from either of the retrieved second set of two previously successively stored sensitivity values;

scheduling a series of new calibration events at predetermined time intervals using the calibration schedule, the series of new calibration events being prior to a scheduled calibration event of the calibration schedule, wherein each of the series of new calibration events is associated with a determination of whether the analyte sensor has reached an acceptable stability point; and

terminating the series of new calibration events according to the sooner of (a) a determination that the analyte sensor has reached the acceptable stability point, or (b) the occurrence of the scheduled calibration event.

13. An apparatus, comprising:

one or more processors; and

a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a sensitivity value associated with an analyte sensor;

to retrieve two stored sensitivity values associated with the analyte sensor, the two stored sensitivity values being previously successively stored;

to compare the determined sensitivity value to the retrieved sensitivity values to determine whether the determined sensitivity value is within a predetermined range from either of the retrieved sensitivity values;

to determine, based on the comparison of the determined sensitivity value to the retrieved sensitivity values, that the determined sensitivity value is within the predetermined range from a first retrieved sensitivity value of the retrieved sensitivity values;

to determine a composite sensitivity for the analyte sensor based on at least the determined sensitivity value and the first retrieved sensitivity value; and

to update buffered data based on the composite sensitivity by at least updating a value of the buffered data, the value corresponding to an analyte level measured by the analyte sensor.

14. The apparatus of claim 13, wherein the first retrieved sensitivity value is associated with a prior calibration parameter used to calibrate the analyte sensor.

15. The apparatus of claim 14, wherein the prior calibration parameter includes a blood glucose value.

16. The apparatus of claim 13, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine the composite sensitivity by applying a first weighted parameter to the determined sensitivity value and applying a second weighted parameter to the first retrieved sensitivity value.

17. The apparatus of claim 16, wherein the first weighted parameter and the second weighted parameter are different.

18. The apparatus of claim 16, wherein the first weighted parameter and the second weighted parameter are the same.

19. The apparatus of claim 16, wherein the first weighted parameter and the second weighted parameter are time based.

20. The apparatus of claim 19, wherein the first retrieved sensitivity value associated with the analyte sensor is based on a prior calibration parameter used to calibrate the analyte sensor prior to a predetermined time period of receiving the prior calibration parameter.

21. The apparatus of claim 19, wherein the first weighted parameter is associated with a current calibration event and the second weighted parameter is associated with a prior calibration event.

22. The apparatus of claim 13, wherein the analyte sensor comprises at least one working electrode including an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

23. The apparatus of claim 22, wherein the analyte sensor further comprises a mediator crosslinked with the polymer.