Device for Providing a Change in a Drug Delivery Rate

• US 20080147041A1
• Filed: 02/27/2006
• Published: 06/19/2008
• Est. Priority Date: 02/28/2005
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Kristensen, Jorgen Smedegaard
• Application Number:
  US11/816,748
• Publication Number:
  US 20080147041A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

The present invention relates to devices for providing an effective change in a drug delivery rate. In an exemplary embodiment the invention provides a drug delivery device using a method for changing a delivery rate for a drug from a first delivery rate to a second higher delivery rate, comprising the steps of: (a) Deliver the drug at the first delivery rate, (b) deliver the drug at a third delivery rate for a first period of time, the third delivery rate being higher than the second delivery rate, and (c) after the first period of time deliver the drug at the second delivery rate. By using a higher “bolus-like” third delivery rate for a first period of time it is possible relatively fast to fill up a depot corresponding to the new second delivery rate.

Claims

1. A method for providing a change in a delivery rate for a drug from a first delivery rate to a second higher delivery rate, comprising the steps of:

deliver the drug at the first delivery rate (401),

deliver the drug at a third delivery rate (403) for a first period of time, the third delivery rate being higher than the second delivery rate, and

after the first period of time deliver the drug at the second delivery rate (402).

2. A method as in claim 1, comprising the further step of:

after the first period of time deliver the drug at a fourth delivery rate (405) for a second period of time, the fourth delivery rate being lower than the second delivery rate, the second delivery rate being higher than zero.

3. A method as in claim 2, wherein the third and fourth delivery rates are substantially constant.

4. A method as in claim 2, wherein the fourth delivery rate is substantially zero.

5. A method as in claim 1, comprising the further step of:

setting the second higher delivery rate before changing the first delivery rate.

6. A method as in claim 5, wherein the second delivery rate is set and calculated on the basis of setting a plasma drug level to be achieved in a subject.

12. A method for providing a change in a delivery rate for a drug, comprising the steps of:

providing a raise in a delivery rate for a drug as defined in claim 1, and

providing a lowering of a delivery rate for a drug as defined in claim 7.

13. A method for providing a change in a delivery rate for a drug, comprising the steps of:

providing a lowering of a delivery rate for a drug as defined in claim 7, and

providing a raise in a delivery rate for a drug as defined in claim 1.

14. A method as in claim 12, wherein the delivery rate before and after the change in the delivery rate is substantially the same.

33. A method as in claim 1, wherein the first and second delivery rates are substantially constant.

34. A method for providing a percentage change in a delivery profile for a drug for a time interval, the delivery profile within the time interval comprising at least two delivery rates, the method comprising the steps of:

deliver the drug according to an initial profile,

creating for the time interval a temporary profile having delivery rates corresponding to a set percentage of the delivery rates of the initial profile, and

deliver the drug in accordance with the temporary profile,

wherein at least one raise in the delivery rate is in accordance with a method as defined in claim 1, and

wherein at least one lowering of the delivery rate is in accordance with a method as defined in claim 7.

35. A method as in claim 34, comprising, before changing the initial profile, the further steps of:

setting the time interval, and

setting the percentage.

36. A method as in claim 1, comprising the further step of calculating at least one delivery rate on the basis of a plasma drug level to be achieved in a subject.

37. A drug delivery device (100, 200) comprising:

a reservoir (230) adapted to contain a fluid drug,

an expelling assembly (220) adapted for cooperation with the reservoir to expel fluid drug from the reservoir to a subject via an outlet,

input means (130) configured to receive settings from a user, and

processor means (110) for controlling the expelling assembly,

wherein the processor means are configured to control the expelling assembly in accordance with a method as defined in claim 1.

38. A drug delivery device as in claim 37, comprising:

a first unit in which the reservoir, expelling assembly and processor means are arranged, and

a second unit comprising the user input means, wherein

the first and second units are adapted for wireless transmission of the received settings from the second to the first unit.

40. A drug delivery device as in claim 37, further comprising a display device adapted to graphically display the actual infusion rates as a function of time.

41. A drug delivery device as in claim 37, further comprising a display device adapted to graphically display only the intended first and second infusion rates as a function of time.

42. A drug delivery device as in claim 37, further comprising a display device adapted to graphically display, as a function of time, calculated plasma drug levels to be achieved in a subject on the basis of actual drug delivery rates.

43. A computer program product for carrying out the method according to claim 1 when said computer program product is run on a computer or a microprocessor.

44. A method for providing a change in a basal plasma drug level in a subject, comprising the steps of:

providing a drug delivery device adapted to expel a fluid drug at a controlled rate from an outlet,

establishing a fluid communication between the outlet and the subcutaneous tissue of the subject,

delivering drug to the subcutaneous tissue in accordance with a delivery rate or profile, and

change the delivery rate or profile for the drug in accordance with a method as defined in claim 1.

7. A method for providing a change in a delivery rate for a drug from a first delivery rate to a second lower delivery rate higher than zero, comprising the steps of:

deliver the drug at a first delivery rate (411),

deliver the drug at a third delivery rate (413) for a first period of time, the third delivery rate being lower than the second delivery rate, and

after the first period of time deliver the drug at the second delivery rate (412).

8. A method as in claim 7, wherein the third delivery rate is substantially constant.

9. A method as in claim 7, wherein the third delivery rate is substantially zero.

10. A method as in claim 7, comprising the further step of:

setting the second lower delivery rate before changing the first delivery rate.

11. A method as in claim 10, wherein the second delivery rate is set and calculated on the basis of setting a plasma drug level to be achieved in a subject.

15. A method for providing a change in a delivery rate for a drug from a first delivery rate to a second higher delivery rate within a time interval, the first delivery rate being higher than zero, comprising the steps of:

deliver the drug at the first delivery rate (401),

at the start of or before the time interval deliver the drug at a third delivery rate (403) for a first period of time, the third delivery rate being higher than the second delivery rate,

after the first period of time deliver the drug at the second delivery rate (402),

at the end of or before the end of the time interval deliver the drug at a fourth (404) delivery rate for a second period of time, the forth delivery rate being lower than the first delivery rate, and

after the second period of time deliver the drug at the first delivery rate (401).

16. A method as in claim 15, wherein the third and fourth delivery rates are substantially constant.

17. A method as in claim 15, wherein the fourth delivery rate is substantially zero.

18. A method as in claim 15, comprising the further step of:

after the first period of time deliver the drug at a fifth delivery rate (405) for a third period of time, the fifth delivery rate being lower than the second delivery rate.

19. A method as in claim 18, wherein the fifth delivery rate is substantially constant.

20. A method as in claim 18, wherein the fifth delivery rate is substantially zero.

21. A method as claim 15, wherein delivery of the drug at the fourth delivery rate begins before the end of the time interval.

22. A method as in claim 15, comprising, before changing the first delivery rate, the further steps of:

setting the time interval,

setting the second higher delivery rate for the time interval.

23. A method as in claim 22, wherein the second delivery rate is set and calculated on the basis of setting a plasma drug level to be achieved in a subject.

24. A method for providing a change in a delivery rate for a drug from a first delivery rate to a second lower delivery rate within a time interval, the second delivery rate being higher than zero, comprising the steps of:

deliver the drug at a first delivery rate (411),

at the start of or before the time interval deliver the drug at a third delivery rate (413) for a first period of time, the third delivery rate being lower than the second delivery rate,

after the first period of time deliver the drug at the second delivery rate (412),

at the end of or before the end of the time interval deliver the drug at a fourth delivery rate (414) for a second period of time, the forth delivery rate being higher than the first delivery rate, and

after the second period of time deliver the drug at the first delivery rate (411).

25. A method as in claim 24, wherein the third and fourth delivery rates are substantially constant.

26. A method as in claim 24, wherein the third delivery rate is substantially zero.

27. A method as in claim 24, comprising the further step of:

after the second period of time deliver the drug at a fifth delivery rate (415) for a third period of time, the fifth delivery rate being lower than the first delivery rate.

28. A method as in claim 27, wherein the fifth delivery rate is substantially constant.

29. A method as in claim 27, wherein the fifth delivery rate is substantially zero.

30. A method as in claim 24, wherein delivery of the drug at the third delivery rate begins before the start of the time interval.

31. A method as in claim 24, comprising, before changing the first delivery rate, the further steps of:

setting a time interval,

setting the second lower delivery rate for the time interval.

32. A method as in claim 31, wherein the second delivery rate is set and calculated on the basis of setting a plasma drug level to be achieved in a subject.

39. A drug delivery device as in 38, further comprising a transcutaneous device unit, the transcutaneous device unit comprising:

a hollow transcutaneous device,

a fluid port in fluid communication with the flexible cannula,

a mounting surface adapted for application to the skin of a subject,

the first unit further comprising;

coupling means allowing the first unit to be attached to the transcutaneous device unit, the expelling assembly being adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the fluid port and the transcutaneous device.