SEMI-CLOSED LOOP INSULIN DELIVERY

• US 20110071464A1
• Filed: 09/23/2009
• Published: 03/24/2011
• Est. Priority Date: 09/23/2009
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Palerm, Cesar C.
• Application Number:
  US12/565,574
• Publication Number:
  US 20110071464A1
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 20/17 delivered via infusion or injection

Abstract

Subject matter disclosed herein relates to a semi-closed loop drug delivery system. In particular embodiments, an amount of insulin to be administered to a patient may be calculated based, at least in part, on one or more blood-glucose measurements obtained from said patient, and an alarm may be initiated in response to the calculated amount of insulin. At least a portion of the calculated amount of insulin may then be injected into the patient in the absence of a response to the alarm within a time limit.

Claims

1. A method comprising:

calculating an amount of insulin to be administered to a patient based, at least in part, on sensor measurements obtained from said patient;

initiating an alarm in response to said calculated amount of insulin; and

automatically initiating injection of at least a portion of said calculated amount in the absence of a response to said alarm within a time limit of said initiation of said alarm.

2. The method of claim 1, wherein said at least a portion of said calculated amount is less than said calculated amount.

3. The method of claim 1, wherein said calculating said amount of insulin comprises estimating an amount of insulin on board.

4. The method of claim 1, wherein said calculating said amount of insulin further comprises calculating said amount of insulin based, at least in part, on a blood-glucose target and an insulin correction factor associated with said patient.

5. The method of claim 4, wherein said at least a portion of said calculated amount of insulin is based, at least in part, on a lower limit for a corrected blood-glucose concentration in said patient.

6. The method of claim 1, wherein said sensor measurements are correlated with a blood-glucose concentration in said patient.

7. The method of claim 1, wherein said sensor measurements comprise blood-glucose sensor measurements.

8. The method of claim 1, wherein said sensor measurements comprise ketone sensor measurements.

9. The method of claim 4, wherein said blood-glucose concentration is measured by a blood glucose sensor, and wherein said at least a portion of said calculated amount of insulin is based, at least in part, on an estimate of a measurement error associated with said blood glucose sensor.

10. A device comprising:

at least one sensor to measure blood-glucose concentration of a patient;

an alarm;

one or more processors programmed with instructions to;

calculate an amount of fluid to be administered to said patient based, at least in part, on sensor measurements obtained from said patient;

initiate said alarm in response to said calculated amount of fluid; and

automatically initiate injection of at least a portion of said calculated amount in the absence of a response to said alarm within a time limit of said initiation of said alarm; and

an infusion device to deliver said amount of fluid to said patient

11. The device of claim 10, wherein said at least a portion of said calculated amount is less than said calculated amount.

12. The device of claim 10, wherein said one or more processors are further programmed with said instructions to calculate said amount of fluid by estimating an amount of fluid on board.

13. The device of claim 10, wherein said one or more processors are further programmed with instructions to calculate said amount of fluid by calculating said amount of fluid based, at least in part, on a blood-glucose target and a fluid correction factor associated with said patient.

14. The device of claim 13, wherein said at least a portion of said calculated amount of fluid is based, at least in part, on a lower limit for a corrected blood-glucose concentration in said patient.

15. The device of claim 10, wherein said sensor measurements are correlated with a blood-glucose concentration in said patient.

16. The device of claim 10, wherein said sensor measurements comprise blood-glucose sensor measurements.

17. The device of claim 10, wherein said sensor measurements comprise ketone sensor measurements.

18. The device of claim 12, wherein said blood-glucose concentration is measured by a blood glucose sensor, and wherein said at least a portion of said calculated amount of fluid is based, at least in part, on an estimate of a measurement error associated with said blood glucose sensor.

19. The device of claim 10, wherein said fluid comprises insulin.

20. An apparatus comprising:

means for calculating an amount of insulin to be administered to a patient based, at least in part, on measurements obtained from said patient;

means for initiating an alarm in response to said calculated amount of insulin; and

means for automatically initiating injection of at least a portion of said calculated amount in the absence of a response to said alarm within a time limit of said initiation of said alarm.

21. The apparatus of claim 20, wherein said at least a portion of said calculated amount is less than said calculated amount.

22. The apparatus of claim 20, wherein said means for calculating said amount of insulin comprises means for estimating an amount of insulin on board.

23. The apparatus of claim 20, wherein said means for calculating said amount of insulin further comprises means for calculating said amount of insulin based, at least in part, on a blood-glucose target and an insulin correction factor associated with said patient.

24. The apparatus of claim 23, wherein said at least a portion of said calculated amount of insulin is based, at least in part, on a lower limit for a corrected blood-glucose concentration in said patient.

25. The apparatus of claim 20, wherein said sensor measurements are correlated with a blood-glucose concentration in said patient.

26. The apparatus of claim 20, wherein said sensor measurements comprise blood-glucose sensor measurements.

27. The apparatus of claim 20, wherein said sensor measurements comprise ketone sensor measurements.

28. The apparatus of claim 23, wherein said blood-glucose concentration is measured by a blood glucose sensor, and wherein said at least a portion of said calculated amount of insulin is based, at least in part, on an estimate of a measurement error associated with said blood glucose sensor.

29. An article comprising:

a storage medium comprising machine-readable instructions stored thereon which, in response to being executed by a processor, enable said processor to;

calculate an amount of insulin to be administered to a patient based, at least in part, on sensor measurements obtained from said patient;

initiate activation of an alarm in response to said calculated amount of insulin; and

automatically initiate injection of at least a portion of said calculated amount into said patient in the absence of a response to said alarm within a time limit of said initiation of said alarm.

30. The article of claim 29, wherein said instructions, in response to being executed by said processor, further enable said processor to calculate said amount of insulin by estimating an amount of insulin on board.

31. The article of claim 29, wherein said instructions, in response to being executed by said processor, further enable said processor to calculate said amount of insulin by calculating said amount of insulin based, at least in part, on a blood-glucose target and a insulin correction factor associated with said patient.

32. The article of claim 31, wherein said at least a portion of said calculated amount of insulin is based, at least in part, on a lower limit for a corrected blood-glucose concentration in said patient.

33. A method comprising:

measuring a patient'"'"'s blood-glucose concentration based, at least in part, on measurements obtained at a sensor;

calculating a correction bolus based, at least in part, on said measured blood-glucose concentration and said patient'"'"'s insulin correction factor.

calculating a worst-case value of blood-glucose based, at least in part, on said measured blood-glucose concentration and a relative sensor error of said sensor;

calculating a maximum allowable bolus based, at least in part, on said worst-case value of blood-glucose concentration and a safety target limit; and

delivering less than said correction bolus to said patient if said correction bolus is less than said maximum allowable bolus.

34. The method of claim 33, further comprising:

further reducing a bolus delivered to said patient based, at least in part, on insulin-on-board.

35. A device comprising:

at least one sensor to measure blood-glucose concentration of a patient;

one or more processors programmed with instructions to;

calculate a correction bolus based, at least in part, on said measured blood-glucose concentration and said patient'"'"'s insulin correction factor.

calculate a worst-case value of blood-glucose concentration based, at least in part, on said measured blood-glucose concentration and a relative sensor error of said sensor; and

calculate a maximum allowable bolus based, at least in part, on said worst-case value of blood-glucose concentration and a safety target limit; and

initiate delivery of less than said correction bolus to said patient if said correction bolus is less than said maximum allowable bolus.

36. The device of claim 35, wherein said one or more processors are further programmed with instructions to further reduce a bolus delivered to said patient based, at least in part, on insulin-on-board.

37. A method comprising:

calculating an amount of insulin to be administered to a patient based, at least in part, on measurements obtained from said patient;

automatically initiating injection of at least a portion of said calculated amount if said patient fails to manually inject insulin within a time limit if blood-glucose measurements surpass a threshold level.

38. The method of claim 37, wherein said at least a portion of said calculated amount is less than said calculated amount.

39. The method of claim 37, wherein said calculating said amount of insulin comprises estimating an amount of insulin on board.

40. The method of claim 37, wherein said sensor measurements are correlated with a blood-glucose concentration in said patient.

41. The method of claim 37, wherein said sensor measurements comprise blood-glucose sensor measurements.

42. The method of claim 37, wherein said sensor measurements comprise ketone sensor measurements.