Closed loop control with reference measurement and methods thereof

• US 10,406,286 B2
• Filed: 04/16/2018
• Issued: 09/10/2019
• Est. Priority Date: 08/31/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US15/953,623
• Publication Number:
  US 20180296758A1
• Time in Patent Office: 512 Days
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting an impending administration of the medication level exceeding a predetermined threshold level, retrieving one or more signals associated with the monitored physiological condition, determining an accuracy indication of the retrieved one or more signals associated with the monitored physiological condition, and executing the administration of the medication level based on the accuracy indication are provided.

Claims

1. A method comprising:

monitoring a physiological condition corresponding to information received from an in vivo analyte sensor and automatic administration of a medication;

detecting a potential fault condition or failure mode associated with the in vivo analyte sensor;

causing the medication to be delivered according to a predetermined delivery rate in response to detecting the potential fault condition or failure mode; and

causing, upon correction of the potential fault condition or failure mode or upon confirmation that the in vivo analyte sensor is in a proper operation mode, the medication to be delivered according to a dynamic delivery rate instead of the predetermined delivery rate;

wherein the dynamic delivery rate is based upon the information received from the in vivo analyte sensor.

2. The method of claim 1, wherein the predetermined delivery rate is associated with a predetermined delivery profile.

3. The method of claim 2, wherein the predetermined delivery profile includes a basal profile.

4. The method of claim 1, wherein the potential fault condition or failure mode includes a false positive value in the information received from the in vivo analyte sensor.

5. The method of claim 1, wherein the physiological condition includes a glucose level and the medication includes insulin.

6. The method of claim 1, further comprising modifying the predetermined delivery rate based on a delivered amount of the medication to maintain a safety level associated with an amount of the medication to be delivered.

7. The method of claim 1, further comprising executing one or more routines to confirm whether the in vivo analyte sensor is in the proper operation mode.

8. The method of claim 7, wherein the one or more routines are selected from the group consisting of verification of calibration information, confirmation that sensor sensitivity does not exceed a predetermined level, and any combination thereof.

9. The method of claim 1, further comprising receiving confirmation of the presence of the detected potential fault condition or failure mode.

10. The method of claim 9, further comprising performing a corrective action to correct the confirmed potential fault condition or failure mode.

11. The method of claim 10, wherein the corrective action is selected from the group consisting of replacing the in vivo analyte sensor, recalibrating the in vivo analyte sensor, and any combination thereof.

12. The method of claim 1, further comprising modifying the dynamic delivery rate based on a medication on board level.

13. A device comprising:

one or more processors; and

a memory operatively coupled to the one or more processors, wherein the one or more processors are configured to;

monitor a physiological condition corresponding to information received from an in vivo analyte sensor and automatic administration of a medication;

detect a potential fault condition or failure mode associated with the in vivo analyte sensor;

cause the medication to be delivered according to a predetermined delivery rate in response to detection of the potential fault condition or failure mode; and

cause, upon correction of the potential fault condition or failure mode or upon confirmation that the in vivo analyte sensor is in a proper operation mode, the medication to be delivered according to a dynamic delivery rate instead of the predetermined delivery rate;

wherein the dynamic delivery rate is based upon the information received from the in vivo analyte sensor.

14. The device of claim 13, wherein the one or more processors are configured to execute one or more routines to confirm whether the in vivo analyte sensor is in the proper operation mode.

15. The device of claim 13, wherein the one or more processors are configured to request confirmation of the presence of the detected potential fault condition or failure mode.

16. The device of claim 13, wherein the one or more processors are configured to correct the detected potential fault condition or failure mode.

17. The device of claim 13, wherein the potential fault condition or failure mode includes a false positive value in the information received from the in vivo analyte sensor.

18. The device of claim 13, wherein the one or more processors are configured to modify the predetermined delivery rate based on a delivered amount of the medication to maintain a safety level associated with an amount of the medication to be delivered.

19. The device of claim 13, wherein the predetermined delivery rate is associated with a predetermined delivery profile.

20. The device of claim 13, wherein the physiological condition includes a glucose level and the medication is insulin.