Closed Loop Control System with Safety Parameters and Methods

• US 20130218126A1
• Filed: 02/13/2013
• Published: 08/22/2013
• Est. Priority Date: 10/23/2007
• 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, Taub, Marc Barry, Bernstein, Daniel Milfred, Sloan, Mark Kent
• Granted Patent: US 10,173,007 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• 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: 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: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• 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: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

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 adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation, and initiating a non-zero pre-programmed medication delivery rate are provided.

Claims

1. A method, comprising:

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 adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation; and

initiating a non-zero pre-programmed medication delivery rate.

2. The method of claim 1 wherein the plurality of parameters monitored includes analyte level, insulin administration level, exercise level, analyte sensor signal condition, insulin on board information, signal transmission level, or one or more combinations thereof.

3. The method of claim 1 wherein the detected adverse condition includes one or more of a failed communication state between a medication delivery device and a controller executing the closed loop control operation, absence of a valid analyte level information, or detection of medication delivery level exceeding a predetermined threshold level.

4. The method of claim 1 wherein the non-zero pre-programmed medication delivery rate includes an open loop medication delivery rate.

5. The method of claim 1 further including:

estimating insulin on board information; and

modifying the non-zero pre-programmed medication delivery rate based on the estimated insulin on board information.

6. The method of claim 5 further including outputting a notification based on the estimated insulin on board information.

7. The method of claim 6 wherein the notification includes one or more of a recommendation to modify the medication delivery rate, or a recommendation to verify the blood glucose level.

8. The method of claim 1 wherein detecting the adverse condition includes:

retrieving the predetermined safety level information;

confirming the presence of the detected adverse condition; and

disabling the automatic medication delivery function.

9. The method of claim 1 wherein detecting the adverse condition includes:

determining a severity level of the detected adverse condition based on the predetermined safety level information; and

generating closed loop operation instruction based on the severity level determination.

10. A device, comprising:

one or more processors; and

a memory operatively coupled to the one or more processors, the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to monitor a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detect an adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation, and initiate a non-zero pre-programmed medication delivery rate.

11. The device of claim 10, wherein the plurality of parameters monitored includes analyte level, insulin administration level, exercise level, analyte sensor signal condition, insulin on board information, signal transmission level, or one or more combinations thereof.

12. The device of claim 10 wherein the detected adverse condition includes one or more of a failed communication state between a medication delivery device and a controller executing the closed loop control operation, absence of a valid analyte level information, or detection of medication delivery level exceeding a predetermined threshold level.

13. The device of claim 10 wherein the non-zero pre-programmed medication delivery rate includes an open loop medication delivery rate.

14. The device of claim 10 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to estimate insulin on board information, and modify the non-zero preprogrammed medication delivery rate based on the estimated insulin on board information.

15. The device of claim 14 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to output a notification based on the estimated insulin on board information.

16. The device of claim 15 wherein the notification includes one or more of a recommendation to modify the medication delivery rate, or a recommendation to verify the blood glucose level.

17. The device of claim 10 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to retrieve the predetermined safety level information, confirm the presence of the detected adverse condition, and disable the automatic medication delivery function.

18. The device of claim 10 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a severity level of the detected adverse condition based on the predetermined safety level information, and generate closed loop operation instruction based on the severity level determination.

19. The device of claim 10 including one or more of an infusion device, or an analyte monitoring device.

20. The device of claim 10 including a blood glucose meter.