External infusion device with programmable capabilities to time-shift basal insulin and method of using the same

• US 7,704,226 B2
• Filed: 11/17/2005
• Issued: 04/27/2010
• Est. Priority Date: 11/17/2005
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Tolle, Mike Charles Vallet, Davis, Carol L., Torres, Linda I., Mueller, John C. Jr., Williams, Gary L., Kovelman, Paul H.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/282,453
• Publication Number:
  US 20070112298A1
• Time in Patent Office: 1,622 Days
• Field of Search: 604/65, 604/66, 604/891.1
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

An external infusion device for delivering insulin from a reservoir into a body of a user includes the capability to deliver time-shifted basal insulin. The external infusion device includes at least one drive mechanism operatively couplable to the reservoir to deliver insulin into the body of the user, at least one processor to control the external infusion device, at least one power supply, at least one display device operatively coupled to the processor to provide visual information to the user, at least one input device operatively coupled to the processor to allow the user to command the processor, and a housing. Time-shifting of basal insulin occurs when a portion of basal insulin is added to a bolus, to a current basal rate, or to a bolus and a current basal rate.

Claims

1. An external infusion device for delivering insulin from a reservoir into a body of a user, the external infusion device comprising:

at least one drive mechanism operatively couplable to the reservoir to deliver insulin into the body of the user;

at least one processor to control the external infusion device;

at least one power supply;

at least one display device operatively coupled to the at least one processor to provide visual information to the user;

at least one input device operatively coupled to the at least one processor to allow the user to command the at least one processor; and

a housing;

wherein the external infusion device is programmed to deliver three different types of basal insulin, the three types of basal insulin including current basal insulin, future basal insulin and time-shifted basal insulin, time-shifted basal insulin being a portion of the future basal insulin that is added to the current basal insulin, the portion of future basal insulin being insulin that is to be delivered during a future time period,

the delivery of the time-shifted basal insulin automatically eliminates delivery of the future basal insulin during the future time period.

2. An external infusion device according to claim 1, wherein the amount of time-shifted basal insulin to be delivered is selected by the user.

3. An external infusion device according to claim 1, wherein the amount of time-shifted basal insulin to be delivered is selected by the at least one processor.

4. An external infusion device according to claim 1, wherein the time-shifted basal insulin is added to a current basal rate.

5. An external infusion device according to claim 1, wherein the amount of time-shifted basal insulin to be delivered is based on a fixed number of Units of insulin.

6. An external infusion device according to claim 1, wherein time-shifted basal insulin is added to at least one of a current basal rate and a bolus.

7. An external infusion device according to claim 1, wherein the amount of time-shifted basal insulin to be delivered is based on externally supplied values.

8. An external infusion device according to claim 7, wherein the externally supplied values include at least one of insulin action, insulin sensitivity, insulin-on-board, basal-on-board, anticipated carbohydrate intake, carbohydrate ratio, glycemic index values, blood glucose levels, and target blood glucose values.

9. An external infusion device according to claim 1, wherein the amount of time-shifted basal insulin to be delivered is based on a percentage of a user'"'"'s current basal rate.

10. An external infusion device according to claim 9, wherein the user determines the percentage of the user'"'"'s current basal rate to be used.

11. An external infusion device according to claim 9, wherein the at least one processor recommends the percentage of the user'"'"'s current basal rate to be used.

12. An external infusion device according to claim 9, wherein the percentage of current basal rate is based on externally supplied values including at least one of insulin action, insulin sensitivity, insulin-on-board, basal-on-board, anticipated carbohydrate intake, carbohydrate ratio, glycemic index values, blood glucose level, and target blood glucose value.

13. An external infusion device according to claim 1, wherein the at least one processor determines the amount of time-shifted basal insulin based on blood glucose trends.

14. An external infusion device according to claim 13, wherein the blood glucose trends are supplied to the at least one processor by the user.

15. An external infusion device according to claim 13, wherein the blood glucose trends are downloaded to the external infusion device from a remote programmer.

16. An external infusion device according to claim 1, further including a glucose monitoring system to provide current blood glucose data to the at least one processor.

17. An external infusion device according to claim 16, wherein the external infusion device include a rate of change alarm to notify the user of changes in blood glucose levels.

18. An external infusion device according to claim 17, wherein the at least one processor recommends delivery of time-shifted basal insulin upon activation of the rate of change alarm.

19. An external infusion device according to claim 1, wherein the time-shifted basal insulin is added to at least one bolus.

20. An external infusion device according to claim 19, wherein the at least one processor includes at least one customizable bolus delivery profile.

21. An external infusion device according to claim 20, wherein the at least one customizable bolus delivery profile includes at least one of a square wave bolus, a dual wave bolus, a normal bolus, a meal bolus, and a time-shifted basal insulin bolus.

22. An external infusion device for delivering insulin from a reservoir into a body of a user, the external infusion device comprising:

at least one drive mechanism operatively couplable to the reservoir to deliver insulin into the body of the user;

at least one processor to control the external infusion device;

at least one power supply;

at least one display device operatively coupled to the at least one processor to provide visual information to the user;

at least one input device operatively coupled to the at least one processor to allow the user to command the at least one processor; and

a housing;

wherein the external infusion device is programmed to deliver three different types of basal insulin, the three types of basal insulin including current basal insulin, future basal insulin and time-shifted basal insulin, time-shifted basal insulin being a portion of the future basal insulin that is added to the current basal insulin, the portion of the future basal insulin being insulin that is to be delivered during a future time period,

the delivery of the time-shifted basal insulin automatically eliminates delivery of the future basal insulin during the future time period;

further including at least one alarm to provide alerts to the user.

23. An external infusion device according to claim 22, wherein the amount of time-shifted basal insulin is selected by the user.

24. An external infusion device according to claim 22, wherein the amount of time-shifted basal insulin is selected by the at least one processor.

25. An external infusion device according to claim 22, wherein the amount of time-shifted basal insulin is based on a fixed number of Units of insulin.

26. An external infusion device according to claim 22, wherein time-shifted basal insulin is also added to at least one bolus.

27. An external infusion device according to claim 22, wherein the at least one alarm is used to remind the user to deliver time-shifted basal insulin.

28. An external infusion device according to claim 22, wherein the at least one alarm is used to remind the user to check blood glucose levels.

29. An external infusion device according to claim 22, wherein the amount of time-shifted basal insulin is based on externally supplied values.

30. An external infusion device according to claim 29, wherein the externally supplied values include at least one of insulin action, insulin sensitivity, insulin-on-board, basal-on-board, anticipated carbohydrate intake, carbohydrate ratio, glycemic index values, blood glucose level, and target blood glucose value.

31. An external infusion device according to claim 22, wherein the amount of time-shifted basal insulin is based on a percentage of a user'"'"'s current basal rate.

32. An external infusion device according to claim 31, wherein the user determines the percentage of the user'"'"'s current basal rate.

33. An external infusion device according to claim 31, wherein the at least one processor recommends the percentage of the user'"'"'s current basal rate.

34. An external infusion device according to claim 31, wherein the percentage of current basal rate is based on externally supplied values including at least one of insulin action, insulin sensitivity, insulin-on-board, basal-on-board, anticipated carbohydrate intake, carbohydrate ratio, glycemic index values, blood glucose level, and target blood glucose value.

35. An external infusion device according to claim 22, wherein the at least one processor determines the amount of time-shifted basal insulin based on blood glucose trends.

36. An external infusion device according to claim 35, wherein the blood glucose trends are supplied to the at least one processor by the user.

37. An external infusion device according to claim 35, wherein the blood glucose trends are downloaded to the external infusion device from a remote programmer.

38. An external infusion device according to claim 22, further including a glucose monitoring system to provide current blood glucose data to the at least one processor.

39. An external infusion device according to claim 38, wherein the external infusion device include a rate of change alarm to notify the user of changes in blood glucose levels.

40. An external infusion device according to claim 39, wherein the at least one processor recommends delivery of time-shifted basal insulin upon activation of the rate of change alarm.

41. An external infusion device for delivering insulin from a reservoir into a body of a user, the external infusion device comprising:

at least one drive mechanism operatively couplable to the reservoir to deliver insulin into the body of the user;

at least one processor to control the external infusion device;

at least one power supply;

at least one display device operatively coupled to the at least one processor to provide visual information to the user;

at least one input device operatively coupled to the at least one processor to allow the user to command the at least one processor; and

a housing;

wherein the external infusion device is programmed to deliver three different types of basal insulin, the three types of basal insulin including current basal insulin, future basal insulin and time-shifted basal insulin, time-shifted basal insulin being a portion of the future basal insulin that is added to the current basal insulin and to at least one bolus, the portion of future basal insulin being insulin that is to be delivered during a future time period,

the delivery of the time-shifted basal insulin automatically eliminates delivery of the future basal insulin during the future time period.

42. An external infusion device according to claim 41, wherein the amount of time-shifted basal insulin is selected by the user.

43. An external infusion device according to claim 41, wherein the amount of time-shifted basal insulin is selected by the at least one processor.

44. An external infusion device according to claim 41, wherein time-shifted basal insulin is also added to the user'"'"'s current basal rate.

45. An external infusion device according to claim 41, wherein the amount of time-shifted basal insulin is based on a fixed number of Units of insulin.

46. An external infusion device according to claim 41, wherein the amount of time-shifted basal insulin is based on externally supplied values.

47. An external infusion device according to claim 46, wherein the externally supplied values include at least one of insulin action, insulin sensitivity, insulin-on-board, basal-on-board, anticipated carbohydrate intake, carbohydrate ratio, glycemic index values, blood glucose level, and target blood glucose value.

48. An external infusion device according to claim 41, wherein the amount of time-shifted basal insulin is based on a percentage of a user'"'"'s current basal rate.

49. An external infusion device according to claim 48, wherein the user determines the percentage of the user'"'"'s current basal rate.

50. An external infusion device according to claim 48, wherein the at least on processor recommends the percentage of the user'"'"'s current basal rate.

51. An external infusion device according to claim 48, wherein the percentage of current basal rate is based on externally supplied values including at least one of insulin action, insulin sensitivity, insulin-on-board, basal-on-board, anticipated carbohydrate intake, carbohydrate ratio, glycemic index values, blood glucose level, and target blood glucose value.

52. An external infusion device according to claim 41, wherein the at least one processor determines the amount of time-shifted basal insulin based on blood glucose trends.

53. An external infusion device according to claim 52, wherein the blood glucose trends are supplied to the at least one processor by the user.

54. An external infusion device according to claim 52, wherein the blood glucose trends are downloaded to the external infusion device from a remote programmer.

55. An external infusion device according to claim 41, further including a glucose monitoring system to provide current blood glucose data to the at least one processor.

56. An external infusion device according to claim 55, wherein the external infusion device include a rate of change alarm to notify the user of changes in blood glucose levels.

57. An external infusion device according to claim 56, wherein the at least one processor recommends delivery of time-shifted basal insulin upon activation of the rate of change alarm.

58. An external infusion device according to claim 41, wherein the at least one processor includes at least one customizable bolus delivery profile.

59. An external infusion device according to claim 58, wherein the at least one customizable bolus delivery profile includes different percentages of at least one of a square wave bolus, a dual wave bolus, a normal bolus, a meal bolus, and a time-shifted basal insulin bolus.

60. An external infusion device according to claim 41, further including at least one alarm to provide alerts to the user.

61. An external infusion device according to claim 60, wherein the at least one alarm is used to remind the user to deliver time-shifted basal insulin.

62. An external infusion device according to claim 60, wherein the at least one alarm is used to remind the user to check blood glucose levels.