DRUG DELIVERY DOSE SETTING MECHANISM WITH VARIABLE MAXIMUM DOSE

• US 20100324527A1
• Filed: 05/27/2010
• Published: 12/23/2010
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Plumptre, David Aubrey
• Granted Patent: US 9,345,840 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/3154 limiting maximum permissible dose
• CPC Class Codes: A61M 5/31536 Blocking means to immobilize a selected dose, e.g. to administer equal doses

Abstract

A method and system for proving a drug delivery device having a variable dose. The drug delivery device comprising a first tubular member and a second tubular member rotatably coupled to the first tubular member. A maximum stop component is operatively coupled to the first and second tubular member such that the maximum stop component is movable from a first position to a second position. The first position defines a first maximum dose that may be set by a user of said drug delivery device and the second position defines a second maximum dose that may be set by the user of said drug delivery device.

Claims

1. A drug delivery device having a variable maximum dose, said device comprising:

a first tubular member,

a second tubular member rotatably coupled to said first tubular member, and

a maximum stop component operatively coupled to said first tubular member and said second tubular member,

such that said maximum stop component is movable from a first position to a second position on said first tubular member,

wherein said first position defines a first maximum dose that may be set by a user of said drug delivery device, and

wherein said second position defines a second maximum dose that may be set by said user of said drug delivery device.

2. The invention of claim 1 wherein said second tubular member is external to said first tubular member.

3. The invention of claim 1 wherein movement of said second tubular member moves said maximum dose stop component to from said first position to said second position on said first tubular member.

4. The invention of claim 1 wherein axial movement of said second tubular member engages said maximum stop component to allow said maximum stop component to be moved to said second position on said first tubular member.

5. The invention of claim 4 wherein after engagement of said second tubular member and said maximum stop component, rotational movement of said second tubular member moves said maximum stop component to said second position on said first tubular member.

6. The invention of claim 1 wherein said drug delivery device comprises a non-resettable pen type delivery device.

7. The invention of claim 1 wherein said drug delivery device comprises a resettable pen type delivery device.

8. The invention of claim 1 further comprising a cartridge containing a medicament.

9. The invention of claim 8 wherein said cartridge is a removable cartridge.

10. The invention of claim 9 wherein said cartridge comprises a cartridge containing an insulin type.

11. The invention of claim 10 wherein said insulin type comprises a long acting insulin type.

12. The invention of claim 1 wherein said second tubular member comprises a scale arrangement, said scale arrangement indicative of a dose that may be set by said drug delivery device.

13. The invention of claim 1 wherein said maximum stop component is rotated to said second position on said first tubular member.

14. The invention of claim 13 wherein said maximum stop component is rotated in a clockwise direction to said second position on said first tubular member.

15. The invention of claim 13 wherein said maximum stop component is rotatable in a counter-clockwise direction to said second position on said first tubular member.

16. The invention of claim 13 wherein said maximum stop component is rotatable in both a counter-clockwise and a clockwise direction.

17. The invention of claim 1 wherein said first position of said maximum stop component defines a maximum dose range, said maximum dose range being a pre-defined region over which said user can re-adjust a maximum dose of said drug delivery device.

18. The invention of claim 1 wherein said second position of said maximum stop component defines a maximum dose range, said maximum dose range being a pre-defined region over which said user can re-adjust a maximum dose of said drug delivery device.

19. A drug delivery device having a variable maximum dose, said device comprising:

a housing, said housing comprising

a helical groove, and

a plurality of ratchet teeth;

a dial sleeve rotatably coupled to said helical groove of said housing, and

a first stop component engaging a first set of said plurality of ratchet teeth of said housing, said first stop component located at a first stop position defining a first maximum dose of said drug delivery device;

wherein said dial sleeve moves said first stop component to a second set of said plurality of said ratchet teeth so that said first stop component moves to a second stop location, said second stop location defining a second maximum dose of said drug delivery device.

20. The invention of claim 19 wherein rotational movement of said dial sleeve moves said first stop component to said second stop position.

21. The invention of claim 19 wherein clockwise rotational movement of said dial sleeve moves said first stop component to said second stop position.

22. The invention of claim 19 wherein counter-clockwise rotational movement of said dial sleeve moves said first stop component to said second stop position.

23. The invention of claim 19 wherein dial sleeve may be rotated in either a clockwise or a counter-clockwise direction.

24. The invention of claim 19 wherein said stop component comprises

a plurality of internal features that releasably engage said first set of said plurality of external ratchet teeth,

a maximum dose stop face;

and

a maximum dose stop position face.

25. The invention of claim 20 wherein when said dial sleeve is moved to said first position, a first stop face of said dial sleeve engages said maximum dose stop face of said first stop component and thus defines a first maximum dose.

26. The invention of claim 25 further comprising:

a second stop face of said dial sleeve engages, said second stop face engages said maximum dose stop position face and moves said first stop component along said inner housing such that said internal features of said first stop component engage a second set of said plurality of ratchet teeth of said inner housing to define a second maximum dose.

27. The invention of claim 19 wherein said first maximum dose is greater than said second maximum dose.

28. The invention of claim 19 further comprising a second stop component.

29. The invention of claim 19 wherein said dial sleeve includes a numeric scale, said scale viewable by a user of the drug delivery device and representative of a dose that may be set by said pen type drug delivery device.

30. The invention of claim 19 wherein said first position defines a maximum dose range, said maximum dose range being a pre-defined region over which said user can re-adjust a maximum dose.

31. A method for providing a drug delivery device having a first and a second maximum dose, said method comprising the steps of:

a. positioning a plurality of ratchet teeth on an inner housing;

b. engaging a first stop component having a plurality of internal features along a set of said plurality of ratchet teeth of said inner housing;

c. positioning a number sleeve in a first position so that

said plurality of ratchet teeth of said inner housing engage a first set of said plurality of said internal features of said first stop component defining said first maximum dose, and

preventing said inner housing plurality of ratchet teeth from disengaging said plurality of internal feature of said first stop component;

d. displacing said number sleeve in a second position;

e. disengaging said inner housing plurality of ratchet teeth from said plurality of internal features of said first stop component; and

e. manipulating said number sleeve so as to select a second maximum dose.

32. The method of claim 31 further comprising the step of

engaging a second stop component having a plurality of internal features along a second set of said plurality of ratchet teeth of said inner housing.

33. The method of claim 31 further comprising the step of

providing internal features on said stop component;

and

providing a plurality of external teeth on said inner housing;

wherein said internal features of said stop component engage said external ratchet teeth of said inner housing so as to select a new maximum dose of said drug delivery device.

34. The invention of claim 31 wherein said first position defines a maximum dose range, said maximum dose range being a pre-defined region over which said user can re-adjust a maximum dose.

35. The invention of claim 31 further comprising the step of

rotating said number sleeve to select said second maximum dose.

36. The invention of claim 31 further comprising the step of

rotating said number sleeve in a clockwise direction to select said second maximum dose.

37. The invention of claim 36 further comprising the step of

rotating said number sleeve in a counter-clockwise direction to select a different dose.