CLOSED LOOP/SEMI-CLOSED LOOP THERAPY MODIFICATION SYSTEM

• US 20080269723A1
• Filed: 04/25/2007
• Published: 10/30/2008
• Est. Priority Date: 04/25/2007
• Status: Abandoned Application

• Current Assignee: LG Electronics, Inc. (LG Corporation), Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Yoon, Richard K., Mastrototaro, John J.
• Application Number:
  US11/739,927
• Publication Number:
  US 20080269723A1
• Time in Patent Office: Days
• US Class Current: 604/890.1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1582 Double lumen needles
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A closed loop/semi-closed loop infusion system provides therapy modification and safeguards against the over-delivery or under-delivery of insulin. A glucose sensor system is configured to obtain a measured blood glucose value. A controller is operationally connected with the glucose sensor system and configured to compare the measured blood glucose value to a target blood glucose value and adjust a therapy delivery parameter if the measured blood glucose value is not consistent with the target blood glucose value, wherein the adjusted therapy delivery parameter is limited to be within a boundary. Thereafter, a delivery system delivers therapy at the adjusted therapy delivery parameter.

Claims

1. A method for providing therapy modification in an infusion system, the method comprising:

obtaining a measured blood glucose value;

comparing the measured blood glucose value to a target blood glucose value;

adjusting a therapy delivery parameter if the measured blood glucose value is not consistent with the target blood glucose value, wherein the adjusted therapy delivery parameter is limited to be within a boundary; and

delivering therapy at the adjusted therapy delivery parameter.

2. The method of claim 1, further comprising prompting a patient to accept the adjusted therapy delivery parameter prior to delivering the therapy.

3. The method of claim 1, further comprising performing a safety action if the adjusted therapy delivery parameter exceeds the boundary.

4. The method of claim 1, wherein the therapy delivery parameter is a basal rate.

5. The method of claim 3, wherein the safety action comprises:

reviewing a blood glucose history; and

performing a standard deviation analysis on the blood glucose history to confirm whether the measured blood glucose value is relatively consistent with the blood glucose history.

6. The method of claim 5, wherein the standard deviation analysis is performed if the adjusted therapy delivery parameter will increase the delivery of insulin.

7. The method of claim 3, wherein the safety action comprises notifying a patient of the adjusted therapy delivery parameter.

8. The method of claim 7, wherein the patient is notified of the adjusted therapy delivery parameter with an alarm.

9. The method of claim 7, further comprising prompting the patient to accept the adjusted therapy delivery parameter.

10. The method of claim 3, wherein the safety action comprises prompting a patient to perform a blood glucose strip meter reading to confirm whether the measured blood glucose value is accurate.

11. The method of claim 1, further comprising logging the adjusted therapy delivery parameter.

12. The method of claim 1, wherein the measured blood glucose value is obtained by a glucose sensor system.

13. The method of claim 1, wherein the boundary comprises 25% above or below a preset basal rate.

14. The method of claim 1, wherein the boundary comprises a maximum allowed increase or decrease of a preset basal rate.

15. The method of claim 14, wherein an absolute value of the maximum allowed increase does not equal an absolute value of the maximum allowed decrease.

16. An infusion system for providing therapy modification, the system comprising:

a glucose sensor system configured to obtain a measured blood glucose value; and

a controller operationally connected with the glucose sensor system and configured to compare the measured blood glucose value to a target blood glucose value, and adjust a therapy delivery parameter if the measured blood glucose value is not consistent with the target blood glucose value, wherein the adjusted therapy delivery parameter is limited to be within a boundary; and

a delivery system operationally connected with the controller and configured to deliver therapy at the adjusted therapy delivery parameter.

17. The system of claim 16, wherein the controller prompts a patient to accept the adjusted therapy delivery parameter prior to delivering the therapy.

18. The system of claim 16, wherein the controller performs a safety action if the adjusted therapy delivery parameter exceeds the boundary.

19. The system of claim 16, wherein the therapy delivery parameter is a basal rate.

20. The system of claim 18, wherein the controller performs the safety action by reviewing a blood glucose history and performing a standard deviation analysis on the blood glucose history to confirm whether the measured blood glucose value is relatively consistent with the blood glucose history.

21. The system of claim 20, wherein the controller performs the standard deviation analysis if the adjusted therapy delivery parameter will increase the delivery of insulin.

22. The system of claim 18, wherein the controller performs the safety action by notifying a patient of the adjusted therapy delivery parameter.

23. The system of claim 22, further comprising an alarm for notifying the patient of the adjusted therapy delivery parameter.

24. The system of claim 22, wherein the controller prompts the patient to accept the adjusted therapy delivery parameter.

25. The system of claim 18, wherein the controller performs the safety action by prompting a patient to perform a blood glucose strip meter reading to confirm whether the measured blood glucose value is accurate.

26. The system of claim 16, wherein the controller logs the adjusted therapy delivery parameter.

27. The system of claim 16, wherein the boundary comprises 25% above or below a preset basal rate.

28. The system of claim 16, wherein the boundary comprises a maximum allowed increase or decrease of a preset basal rate.

29. The system of claim 28, wherein an absolute value of the maximum allowed increase does not equal an absolute value of the maximum allowed decrease.

30. An infusion system for providing therapy modification, the system comprising:

means for obtaining a measured blood glucose value;

means for comparing the measured blood glucose value to a target blood glucose value;

means for adjusting a therapy delivery parameter if the measured blood glucose value is not consistent with the target blood glucose value, wherein the adjusted therapy delivery parameter is limited to be within a boundary; and

means for delivering therapy at the adjusted therapy delivery parameter.