Method and Apparatus for Computer Controlled Metering of Liquid Medicaments in the Event of a Time Shift

• US 20070142822A1
• Filed: 12/20/2006
• Published: 06/21/2007
• Est. Priority Date: 12/21/2005
• Status: Abandoned Application

• Current Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Remde, Axel
• Application Number:
  US11/613,643
• Publication Number:
  US 20070142822A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A computer-aided insulin pump by which a basal delivery profile can be automatically adapted in steps in the event of a travel-dependent time shift, in that the local time at the destination is communicated to the pump controller which uses the time, in accordance with a stored algorithm, to calculate one or more changeover delivery profiles which are then temporarily used for automatic control of the insulin pump until the changeover of time has been completed.

Claims

1. A method for operation of a metering apparatus for liquid medicaments with a computer-aided control in the event of a travel-dependent shift in the local time, comprising the steps of:

a) controlling the metering apparatus with the control at a first location with a first local time (t1) such that it automatically delivers the liquid medicament in accordance with a first diurnal profile of delivery;

b) moving the metering apparatus to a second location with a second local time (t2), which is shifted by a first time shift with respect to the first local time (t1); and

c) controlling the metering apparatus with the control directly subsequent to the delivery in accordance with the first diurnal profile of delivery on a temporary basis such that it automatically delivers the liquid medicament in accordance with at least one further diurnal profile of delivery which differs from the first diurnal profile of delivery and from the first diurnal profile of delivery shifted by the first time shift, wherein the at least one further diurnal profile of delivery is determined by the control in dependence on the first time shift.

2. The method according to claim 1, wherein the metering apparatus is, after the second location, moved to a third location with a third local time, which is shifted by a second time shift relative to the second local time (t2), and the metering apparatus temporarily is controlled by the control such that it automatically delivers the liquid medicament in accordance with at least one further diurnal profile of delivery, which differs from the diurnal profile of delivery last used at the second location and from the first diurnal profile of delivery shifted by the sum, with the correct mathematical sign, of the first and the second time shift, wherein the at least one further diurnal profile of delivery is determined by the control in dependence on the second time shift.

3. The method according to claim 2, wherein the further diurnal profile of delivery, which has last been used at the second location deviates from a diurnal profile of delivery which corresponds to the first diurnal profile of delivery shifted by the first time shift, and wherein the deviation is taken into account in the determination of the further diurnal profile of delivery, which is determined in dependence on the second time shift.

4. The method according to claim 1, wherein part or all of further diurnal profiles of delivery correspond to a first diurnal profile of delivery which has been shifted in time by a specific time shift.

5. The method according to claim 4, wherein at least the further diurnal profiles of delivery which follow the diurnal profile of delivery which has last been used at the second location each correspond to a timewise shifted first diurnal profile of delivery, and the diurnal profile of delivery which has last been used at the second location corresponds to a first diurnal profile of delivery which has been shifted merely by a partial amount of the first time shift, and wherein the difference between this partial amount and the total amount of the first time shift is taken into account in the determination of the further diurnal profiles of delivery which are determined in dependence on the second time shift by being added with the correct mathematical sign to the second time shift.

6. The method according to claim 4, wherein the time shift difference between in each case two directly successive diurnal profiles of delivery, which correspond to the first diurnal profile of delivery or to a first diurnal profile of delivery which has been shifted in time by a specific time shift, corresponds to an amount of time which has been obtained by integer division of a time shift which has been used for determination of at least one of the diurnal profiles of delivery.

7. The method according to claim 6, wherein the amount of time is one of less than or equal to 4 hours or less than or equal to 3 hours.

8. The method according to claim 6, wherein the time shift differences between all of the directly successive diurnal profiles of delivery which correspond to the first diurnal profile of delivery or to a first diurnal profile of delivery which has been shifted in time by a specific time shift are identical.

9. The method according to claim 4, wherein a desired or maximum permissible time shift difference between directly successive diurnal profiles of delivery which correspond to the first diurnal profile of delivery or to a first diurnal profile of delivery which has been shifted in time by a specific time shift is communicated to the control by one of a manual input or via an interface and wherein the further diurnal profiles of delivery are determined by the control in dependence on the first or the second time shift and on the desired or maximum permissible time shift difference.

10. The method according to claim 9, wherein the interface is one of wireless or stored in the control.

11. The method according to claim 9, wherein part or all of the further diurnal profiles of delivery correspond to a first diurnal profile of delivery which has been compressed and/or stretched in time essentially continuously variably or at one or more points.

12. The method according to claim 11, wherein the stretching or compression is carried out in intervals by a specific amount of time.

13. The method according to claim 12, wherein the intervals are one of each hour, every 2 hours, every 4 hours or every 6 hours, and wherein the amount of time at all of the stretches or compressions is identical or, seen over the diurnal profile of delivery, stretches and/or compressions with different amounts of time are carried out.

14. The method according to claim 12, wherein all of the stretched or compressed diurnal profiles of delivery have an identical profile shape and are shifted in time with respect to one another.

15. The method according to claim 14, wherein a desired or maximum permissible amount of time for each stretch or compression and/or a desired or maximum and/or minimum permissible number of stretching or compression steps and/or a desired or maximum and/or minimum permissible interval between the stretching and compression steps is communicated to the control by a manual input or by an interface, which is in particular wireless, or is stored in the control and by means of the control further diurnal profiles of delivery are determined automatically in dependence on the first time shift and on the desired or permissible amount of time per stretch or compression and/or on the desired or maximum and/or minimum permissible number of stretching or compression steps and/or on the desired or maximum and/or minimum permissible interval between the stretching or compression steps.

16. The method according to claim 1, wherein at least part of the further diurnal profiles of delivery correspond to a first diurnal profile of delivery which has been shifted in time by a specific time shift and has at the same time been compressed or stretched in time.

17. The method according to claim 1, wherein a diurnal profile of delivery which follows the further diurnal profile or profiles of delivery corresponds to the first diurnal profile of delivery shifted by the first time shift or by the sum of the first and the second time shift.

18. The method according to claim 1, wherein the first and, if appropriate, the second time shift is communicated to the control by a manual input or by data transmission via an interface, which is wireless, or is determined by the control by evaluation of data received via a satellite navigation system.

19. The method according to claim 1, wherein a computer-aided control having at least two separate clocks, which are clocked jointly, is used such that, by a first of the clocks, the second local time or a third local time is administered and is displayed via a display at the metering apparatus, and, by a second of the clocks, the metering apparatus is controlled in accordance with a diurnal profile of delivery, wherein the second of the clocks is automatically set by the control such that it has a time offset with respect to the first local time which is less than the first time shift or the sum of the first and the second time shift.

20. The method according to claim 19, wherein the second of the clocks (4) is automatically set by the control such that it has a time offset with respect to the first local time which corresponds to the time shift of a further diurnal profile of delivery which is currently used to control the metering apparatus with respect to the first diurnal profile of delivery.

21. The method according to claim 20, wherein a degree of changeover of operation of the metering apparatus to the second local time or the third local time is displayed graphically on the metering apparatus, wherein at least one of the distance between graphical elements or the extent of graphical elements serves to illustrate time differences.

22. The method according to claim 20, wherein the relationship of the first local time, the second local time and/or the third local time as well as the actual degree of changeover of the operation of the metering apparatus to the second local time or to the third local time is illustrated graphically by pictograms, wherein distances to each other serve for the illustration of the respective time differences and are proportional to the respective time differences.

23. The method according to claim 22, wherein the actual degree of changeover of operation of the metering apparatus is illustrated in that the actual time of the second clock is displayed in relationship to the second local time, the third local time, and, additionally, the first local time.

24. The method according to claim 23, wherein the second local time and/or the third local time and, additionally, the first local time are displayed as one of an analogue or digital clock display at the metering apparatus.

25. The method according to claim 21, wherein by the metering apparatus additionally boli are calculated in dependence on the current degree of changeover of operation of the metering apparatus to the second local time or the third local time.

26. The method according to claim 25, wherein the boli are calculated such that a greater deviation from the otherwise normal target value or target value corridor of a parameter is permitted in the changeover phase.

27. The method according to claim 21, wherein control data for the metering apparatus are stored as a control history with reference to the first local time, wherein the second local time or the third local time is additionally stored at least on storage of the data relating to therapy-relevant information.

28. The method according to claim 1, wherein the metering apparatus is associated with a computer-controlled insulin pump.

29. A metering apparatus for liquid medicaments, comprising a feed device for moving the liquid medicament and a controller comprising a computer for automatically controlling the feed device in accordance with at least one profile of delivery.

30. The apparatus according to claim 29, wherein the at least one profile of delivery comprises a first diurnal profile of delivery stored in the controller, wherein the controller can determine at least one further diurnal profile of delivery, which differs from the first diurnal profile of delivery.

31. The apparatus according to claim 30, wherein the at least one further diurnal profile differs from the first diurnal profile by a first time shift.

32. The apparatus according to claim 31, wherein the at least one further diurnal profile is determined in dependence on the first time shift, and the feed device is controlled automatically in accordance with the at least one further diurnal profile of delivery.

33. A metering apparatus for liquid medicaments, comprising a feed device for feeding the liquid medicament and a computer-aided control for automatic control of the feed device in accordance with a first diurnal profile of delivery stored in the control, wherein in the event of a first time shift, at least one further diurnal profile of delivery which differs from the first diurnal profile of delivery and from the first diurnal profile of delivery which has been shifted by the first time shift can be determined in dependence on the first time shift and the feed device is automatically controlled by the control in accordance with the at least one further diurnal profile of delivery.

34. The metering apparatus according to claim 33, wherein in the event of a second time shift following the first time shift, at least one further diurnal profile of delivery, which differs from the last used diurnal profile of delivery and from the first diurnal profile of delivery shifted by the sum, with the correct mathematical sign, of the first and the second time shift, can be determined in dependence on the second time shift, and the feed device can be controlled automatically in accordance with the at least one further diurnal profile of delivery which has been determined in dependence on the second time shift.

35. The metering apparatus according to claim 34, wherein if the diurnal profile of delivery which has last been used for the purpose of adaptation to the first time shift deviates from the first diurnal profile of delivery which has been shifted by the first time shift, this deviation can be taken into account automatically in addition to the second time shift in the determination of the at least one further diurnal profile of delivery which is determined in dependence on the second time shift.

36. The metering apparatus according to claim 35, wherein further diurnal profiles of delivery can be determined and be used for automatic controlling, which correspond to a first diurnal profile of delivery which has been shifted in time by a specific time shift.

37. The metering apparatus according to claim 36, wherein a time shift difference which exists when determining the further diurnal profile of delivery in dependence on the second time shift between the first time shift and the time shift of the last used diurnal profile of delivery is automatically taken into account in the determination of the at least one further diurnal profile of delivery, said time shift difference is added with the correct mathematical sign to the second time shift.

38. The metering apparatus according to claim 37, wherein the time shift difference between two directly successive diurnal profiles of delivery, which correspond to the first diurnal profile of delivery or a first diurnal profile of delivery which has been shifted in time by a specific time shift, can be automatically adjusted to correspond to an amount of time which has been obtained by integer division of the time shift used for determination of one of the diurnal profiles of delivery, and wherein the control automatically limits this time shift difference to one of an amount of less than or equal to 4 hours or less than or equal to 3 hours.

39. The metering apparatus according to claim 38, wherein the time shift differences between all of the directly successive diurnal profiles of delivery which correspond to the first diurnal profile of delivery or to a first diurnal profile of delivery which has been shifted in time by a specific time shift can be set to be identical.

40. The metering apparatus according to claim 39, wherein a desired or maximum permissible time shift difference between directly successive diurnal profiles of delivery which correspond to the first diurnal profile of delivery or to a first diurnal profile of delivery which has been shifted in time by a specific time shift can be communicated to the control by one of a manual input or via an interface, which is in particular wireless, or is stored in the control, and the further diurnal profile of delivery can be determined by the control in dependence on the first or the second time shift and on the desired or permissible time shift difference.

41. The metering apparatus according to claim 40, wherein the interface is one of wireless or stored in the control.

42. The metering apparatus according to claim 40, wherein further diurnal profiles of delivery can be determined and be used for automatic controlling, which correspond to a first diurnal profile of delivery which has been compressed and/or stretched in time essentially in a continuously variable manner or at one or more locations.

43. The metering apparatus according to claim 42, wherein the stretching or compression is or can be carried out in intervals of one of selected intervals, each hour, every 2 hours, every 4 hours or every 6 hours, and the amount of time at all of the stretches or compressions can be or is set to be identical or, seen over the diurnal profile of delivery, different amounts of time for the stretches and compressions can be set or are set.

44. The metering apparatus according to claim 42, wherein several successive further diurnal profiles of delivery which have been stretched and/or compressed in time can be determined and be used for automatic controlling, which all have an identical profile shape and are shifted in time with respect to each other.

45. The metering apparatus according to claim 42, wherein at least one of a desired or maximum permissible amount of time for each stretching or compression process, a desired or maximum and/or minimum permissible number of stretching and/or compression steps, and a desired or maximum and/or minimum permissible interval between the stretching or compression steps can be communicated to the control by an interface or are stored in the control, and the further diurnal profiles of delivery can be determined by the control automatically in dependence on the first time shift and at least one of the desired or permissible amount of time per stretching or compression, on the desired or maximum and/or minimum permissible number of stretching or compression steps, and the desired or maximum and/or minimum permissible interval between the stretching or compression steps.

46. The metering apparatus according to claim 33, wherein further diurnal profiles of delivery can be determined and be used for automatic controlling, which correspond to a first diurnal profile of delivery which has been shifted in time by a specific time shift and has been compressed or stretched in time as well.

47. The metering apparatus according to claim 33, wherein a diurnal profile of delivery which follows the further diurnal profile or profiles of delivery determined by it corresponds to the first diurnal profile of delivery shifted by the first time shift or by the sum of the first and the second time shift.

48. The metering apparatus according to claim 33, wherein the respective time shift can be communicated to the control by a manual input or by data transmission via an interface or can be determined by the control by evaluation of data which are received via a satellite navigation system.

49. The metering apparatus according to claim 33, wherein the control comprises at least two separate jointly clocked clocks and administers with a first of the clocks a time which is shifted by the first or second time shift, and displays said time via a display at the metering apparatus, and controls the metering apparatus with the second of said clocks in accordance with a diurnal profile of delivery, wherein the second of the clocks, to control the metering apparatus in accordance with a further diurnal profile of delivery, can be adjusted automatically by the control whereby, before the first time shift, said second clock has a time offset with respect to a base time which is less than the first time shift or the sum of the first and the second time shift.

50. The metering apparatus according to claim 49, wherein the second of the clocks can be adjusted automatically via the control to have a time offset with respect to the base time which corresponds to the time shift of a further diurnal profile of delivery which is currently used to control the metering apparatus with respect to the first diurnal profile of delivery.

51. The metering apparatus according to claim 50, wherein the metering apparatus comprises a display by which a degree of adaptation of the operation of the metering apparatus to the first or second time shift can be displayed graphically, wherein one of the distance between graphical elements and the extent of graphical elements serve for the illustration of time differences.

52. The metering apparatus according to claim 51, wherein the relationship of the base time, of a time which has been shifted by the first time shift or the sum of the first and the second time shift with respect to the base time as well as the current degree of adaptation of the operation of the metering apparatus to the first or second time shift can be illustrated graphically by pictograms, whose distances to each other serve for the illustration of the respective time differences and are proportional to the respective time differences.

53. The metering apparatus according to claim 49, wherein the current degree of adaptation to the time shift can be illustrated by displaying and/or illustrating of the current time of the second clock in relationship to a time which has been shifted by the first time shift or the sum of the first and the second time shift with respect to the base time and can be displayed in addition to the base time.

54. The metering apparatus according to claim 33, wherein the time which has been shifted by the first time shift or the sum of the first and the second time shift with respect to the base time and the base time can be displayed at the metering apparatus as one of an analogue or digital clock display.

55. The metering apparatus according to claim 33, wherein the control is designed for additional calculation of boli, in dependence on the current degree of adaptation of the operation of the metering apparatus to the first or second time shift.

56. The metering apparatus according to claim 55, wherein the boli are calculated or can be calculated such that a greater deviation from the otherwise normal target value or target value corridor of a parameter is temporarily permitted in a changeover phase.

57. The metering apparatus according to claim 56, wherein the control records the control data of the metering apparatus as a control history with reference to the base time and a time shifted by the first time shift or the sum of the first and the second time shift with respect to the base time at least for the recording of the data of therapy-relevant information including bolus deliveries.

58. The metering apparatus according to claim 57, wherein the metering apparatus is used for the metered delivery of insulin.