FILL-FINISH CARTRIDGES FOR STERILE FLUID PATHWAY ASSEMBLIES AND DRUG DELIVERY DEVICES INCORPORATING FILL-FINISH CARTRIDGES

• US 20130237916A1
• Filed: 03/12/2013
• Published: 09/12/2013
• Est. Priority Date: 03/12/2012
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Hanson, Ian B., Bente, Paul F. IV, O'Connor, Sean M., Clemente, Matthew J., Agard, Ryan M., Ciccarelli, Nicholas J.
• Granted Patent: US 11,033,679 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61L 2/00 Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for contact lenses A61L12/00; atomisers for disinfecting agents A61M; sterilisation of packages or package contents in association with packaging B65B55/00; treatment of water, waste water, sewage or sludge C02F; disinfecting paper D21H21/36; disinfecting devices for water closets E03D; articles having provision for disinfection, see the relevant subclasses for these articles, e.g. H04R1/12
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/182 Rigid packaging means
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A fluid pathway assembly includes a needle insertion mechanism, a fluid conduit, and a fluid pathway connection. The fluid pathway assembly may further include a drug container to hold a drug fluid prior to initiation of the injection. The assembly may include a carrier disposed along at least a portion of the fluid pathway assembly, and/or a drug container. The fill-finish cartridge functions to retain the components of the fluid pathway assembly in a sterile condition, while allowing for easy integration of the fluid pathway assembly and the drug container into a standard fill-finish process. Methods of constructing a cartridge, filling a drug container included in a cartridge, and incorporating the same into a drug delivery device are disclosed.

Claims

1. A cartridge for coupling to a drug container for use in a drug delivery device, the cartridge comprising:

a needle insertion mechanism including a needle, and operative to move the needle to an insertion position, and

a fluid pathway connection, the fluid pathway connection being adapted for disposal between the drug container and the needle insertion mechanism and being selectively actuable to fluidly connect the drug container to the needle insertion mechanism, the drug container, the fluid pathway connection, and the needle insertion mechanism defining a sterile fluid flowpath.

2. The cartridge of claim 1 wherein the fluid pathway connection and the needle insertion mechanism are in either axial or non-axial alignment.

3. The cartridge of claim 1 wherein the fluid pathway connection and the needle insertion mechanism are in axial alignment with the drug container when coupled thereto.

4. The cartridge of claim 1 wherein the fluid pathway connection and the needle insertion mechanism are mechanically coupled such that the cartridge may be handled as a unit.

5. The cartridge of claim 1 having sufficient structural integrity to be filled in a fill finish process.

6. The cartridge of claim 1 further including a fluid conduit fluidly coupling the fluid pathway connection and the needle insertion mechanism.

7. The cartridge of claim 1 wherein the fluid pathway connection and the needle insertion mechanism are coupled together at a mechanical connection.

8. The cartridge of claim 7 wherein the fluid pathway connection and the needle insertion mechanism are adapted to remain fluidly coupled when the mechanical connection is decoupled.

9. The cartridge of claim 8 further including a fluid conduit fluidly coupling the fluid pathway connection and the needle insertion mechanism.

10. The cartridge of claim 7 wherein the mechanical connection includes a snap connection.

11. The cartridge of claim 7 wherein the mechanical connection includes a threaded connection.

12. The cartridge of claim 7 wherein the mechanical connection includes an interference fit.

13. The cartridge of claim 7 wherein the mechanical connection includes a tongue and groove connection.

14. The cartridge of claim 7 wherein the mechanical connection includes an external support.

15. The cartridge of claim 1 further comprising the drug container wherein the drug container includes a proximal and a distal end, the cartridge further including a permeable seal disposed at the distal end of the drug container, the fluid pathway connection including a cannula disposed to selectively pierce the permeable seal to fluidly connect the drug container to the needle insertion mechanism.

16. The cartridge of claim 15 wherein the fluid pathway connection is adapted to be assembled to the permeable seal disposed in the drug container.

17. The cartridge of claim 15 wherein the fluid pathway connection is integrated with the permeable seal.

18. The cartridge of claim 1 further comprising a carrier disposed along at least a portion of the cartridge to maintain the relative positions of the needle insertion mechanism, and the fluid pathway connection.

19. The cartridge of claim 18 wherein the carrier includes multiple parts.

20. The cartridge of claim 18 wherein at least a portion of the carrier is removed prior to placement in the drug delivery device.

21. The cartridge of claim 18 wherein at least a portion of the carrier remains with the cartridge when placed in the drug delivery device.

22. The cartridge of claim 18 wherein the carrier surrounds at least a portion of the needle insertion mechanism, and the fluid pathway connection.

23. The cartridge of claim 1 further including the drug container and wherein the drug container includes a proximal end and a distal end, and an axis extending from the proximal to the distal end, and the needle insertion mechanism includes an axis extending along the needle, and wherein the drug container and the needle are not in axial alignment when disposed in the drug delivery device.

24. The cartridge of claim 1 further including the drug container and wherein the drug container includes a proximal end and a distal end, and an axis extending from the proximal to the distal end, and the needle insertion mechanism includes an axis extending along the needle, and wherein the drug container and the needle are in axial alignment when disposed in the drug delivery device.

25. The cartridge of claim 1 wherein the needle insertion mechanism is operative to move the needle to a refracted position following insertion.

26. The cartridge of claim 1 further including the drug container and a drug contained within the drug container, the cartridge being provided in a sterilized form.

27. The cartridge of claim 1 further including the drug container and wherein the drug container includes a plunger seal slidably disposed in a proximal end of the drug container.

28. The cartridge of claim 27 wherein the plunger seal is axially slidable within the drug container to dispense a drug contained there in through the sterile fluid pathway when the fluid pathway is actuated.

29. A drug delivery device comprising

a housing,

a cartridge disposed at least partially within the housing, the cartridge including

a drug container,

a needle insertion mechanism including a needle, and

a fluid pathway connection, the fluid pathway connection being disposed between the drug container and the needle insertion mechanism, the drug container, the fluid pathway connection and the needle insertion mechanism defining a sterile fluid flowpath,

an actuation mechanism, the actuation mechanism being operative to selectively actuate the fluid pathway connection to fluidly connect the drug container to the needle insertion mechanism, and

an injection actuator operative to cause the needle insertion mechanism to move the needle to an insertion position.

30. The drug delivery device of claim 29 wherein the actuation mechanism and the injection actuator are operative by a single user action.

31. The drug delivery device of claim 29 wherein the fluid flowpath is sterile prior to placement in the housing.

32. A method of constructing a cartridge for inclusion in a drug delivery device comprising the steps of

fluidly coupling a fluid pathway connection and a needle insertion mechanism, and

sterilizing the fluid pathway connection and the needle insertion mechanism.

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

sterilizing drug container and permeable seal,

disposing a cannula of the fluid pathway connection adjacent a permeable seal of a drug container, the cannula being operative to pierce the permeable seal as a result of relative movement between the permeable seal and the cannula to provide a fluid connection between the drug container and the fluid pathway connection, and

maintaining the drug container, the fluid pathway connection, and the needle insertion mechanism in a sterile environment.

34. The method of claim 33 wherein the step of sterilizing the fluid pathway connection and the needle insertion mechanism is performed separately from the step of sterilizing the drug container.

35. The method of claim 33 wherein the steps of sterilizing the fluid pathway connection and the needle insertion mechanism and of sterilizing the drug container are performed simultaneously after the step of disposing a cannula of the fluid pathway connection adjacent the permeable seal.

36. The method of claim 33 further comprising disposing a drug to be administered within the drug container using a fill-finish process.

37. The method of claim 36 wherein the step of disposing a drug is performed in a sterile environment after the sterilizing steps.

38. The method of claim 36 wherein the step of disposing a drug is performed after the step of disposing a cannula of the fluid pathway connection adjacent the permeable seal.

39. The method of claim 38 further comprising disposing a plunger seal in a proximal end of the drug container following the disposal of the drug step.

40. The method of claim 36 wherein the step of disposing a drug is performed after the step of disposing a cannula of the fluid pathway connection adjacent the permeable seal.

41. The method of claim 36 wherein the step of disposing a drug is performed through a proximal end of the drug container, and further comprising disposing a plunger seal in the proximal end of the drug container.

42. The method of claim 33 further comprising providing a plurality of said cartridges in a tray.

43. The method of claim 33 wherein the step of coupling the fluid pathway connection and the needle insertion mechanism include engaging at least one of a snap connection, a threaded connection, an interference connection, a tongue and groove connection, or a connection made by a fluid conduit.

44. The method of claim 33 further comprising disposing a carrier along at least a portion of two of the drug container, the fluid pathway connection and the needle attachment mechanism.

45. The method of claim 44 wherein the step of disposing a carrier includes disposing a multipart carrier.

46. The method of claim 44 wherein the step of disposing a carrier includes disposing at least a portion of the carrier about a circumference of at least one of the drug container, the fluid pathway connection and the needle attachment mechanism.

47. A method of constructing a drug delivery device including the steps of

disposing a fill-finish cartridge including a fluid pathway connection, a needle insertion mechanism, and a drug container including a drug to be administered in a housing of the drug delivery device, wherein the cartridge includes a sterilized fluid pathway from the drug container through the fluid pathway connection to the needle insertion mechanism, the sterilized fluid pathway being connected by actuation of the fluid pathway connection.

48. The method of claim 47 further comprising removing at least a portion of a carrier disposed along at least a portion of the drug container, the fluid pathway connection and the needle attachment mechanism.

49. The method of claim 47 further comprising decoupling a mechanical connection between the fluid pathway connection and the needle insertion mechanism while maintaining a fluid coupling therebetween, and disposing the needle insertion mechanism within the housing in nonaxial alignment with the needle fluid pathway connection and drug container.