Robust Closed Loop Control And Methods

Abstract

Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor and automatic delivery of medication at least in part in response to the received analyte sensor signals, determining whether the signal level received from the analyte sensor is associated with one of a fault condition or a potential fault condition, and dynamically adjusting a current infusion rate executed by the closed loop control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or potential fault condition, where medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with a potential fault condition, and where the first predetermined range is narrower compared to the second predetermined range are provided.

1 - 7 . (canceled) 
     
     
         8 . 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   activating a predetermined safety level threshold for medication delivery such that the level of medication administration in the closed loop control operation does not exceed the predetermined safety level threshold.   
     
     
         9 . The method of  claim 8  wherein the safety level threshold includes a maximum safety limit for insulin administration in the closed loop control operation. 
     
     
         10 . The method of  claim 8  including deactivating the predetermined safety level threshold when the detected adverse condition is not present. 
     
     
         11 . The method of  claim 8  including modifying the predetermined safety level threshold based at least in part on the severity of the detected adverse condition. 
     
     
         12 . The method of  claim 8  including outputting a notification to take action in response to the detected adverse condition. 
     
     
         13 . The method of  claim 8  wherein the monitored physiological condition includes monitored glucose level, monitored heart rate, monitored exercise level, monitored blood pressure level, or monitored carbohydrate intake level. 
     
     
         14 . The method of  claim 8  wherein the medication includes insulin, or glucagon, or one or more combinations thereof. 
     
     
         15 . The method of  claim 8  including:
 determining the presence of the adverse condition persistently over a predetermined time period; and   disabling the closed loop control operation.   
     
     
         16 . The method of  claim 15  including generating a notification associated with the disabled closed loop control operation. 
     
     
         17 . The method of  claim 15  including initiating a pre-programmed medication delivery rate. 
     
     
         18 . 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 activate a predetermined safety level threshold for medication delivery such that the level of medication administration in the closed loop control operation does not exceed the predetermined safety level threshold.   
     
     
         19 . The device of  claim 18  wherein the safety level threshold includes a maximum safety limit for insulin administration in the closed loop control operation. 
     
     
         20 . The device of  claim 18  wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to deactivate the predetermined safety level threshold when the detected adverse condition is not present. 
     
     
         21 . The device of  claim 18  wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to modify the predetermined safety level threshold based at least in part on the severity of the detected adverse condition. 
     
     
         22 . The device of  claim 18  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 to take action in response to the detected adverse condition. 
     
     
         23 . The device of  claim 18  wherein the monitored physiological condition includes monitored glucose level, monitored heart rate, monitored exercise level, monitored blood pressure level, or monitored carbohydrate intake level. 
     
     
         24 . The device of  claim 18  wherein the medication includes insulin, or glucacon, or one or more combinations thereof. 
     
     
         25 . The device of  claim 18  wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine the presence of the adverse condition persistently over a predetermined time period, and disable the closed loop control operation. 
     
     
         26 . The device of  claim 25  wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to generate a notification associated with the disabled closed loop control operation. 
     
     
         27 . The device of  claim 25  wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to initiate a pre-programmed medication delivery rate. 
     
     
         28 . The method of  claim 8  wherein the adverse condition includes one or more of an analyte sensor signal attenuation condition, analyte sensor signal dropout condition, or an analyte sensor calibration failure condition. 
     
     
         29 . The method of  claim 8  including outputting an indication of the activated predetermined safety level threshold. 
     
     
         30 . The method of  claim 29  wherein the indication includes one or more of a visual indicator, an audible indicator, or a vibratory indicator. 
     
     
         31 . The method of  claim 8  wherein the monitored physiological condition includes monitored glucose level and further, wherein the medication includes insulin or glucagon. 
     
     
         32 . The device of  claim 18  wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to output an indication of the activated predetermined safety level threshold. 
     
     
         33 . 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 operating within a predetermined safety range of the closed loop control operation;   detecting a signal dropout condition of an analyte sensor monitoring the physiological condition; and   activating a predetermined safety level threshold for medication delivery such that the level of medication administration is modified to not exceed the predetermined safety level threshold within the safety range of the closed loop control operation.   
     
     
         34 . The method of  claim 33  including temporarily disabling the automatic administration of the medication when the detected signal dropout condition is present over a predetermined time period.