Pre-filled drug-delivery device and method of manufacture and assembly of same

• US 6,824,529 B2
• Filed: 04/17/2001
• Issued: 11/30/2004
• Est. Priority Date: 06/16/1997
• Status: Expired due to Term

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Tsals, Izrail, Gross, Joseph
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US09/836,105
• Publication Number:
  US 20020010423A1
• Time in Patent Office: 1,323 Days
• Field of Search: 604/93.01, 604/181, 604/187, 604/233, 604/239, 604/131, 604/140, 604/141, 604/143, 604/145, 604/146, 604/147, 604/272, 604/200, 604/208, 604/220, 604/223, 604/110
• US Class Current: 604/143
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/31591 Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

A drug delivery device having a base member defining a skin-contacting surface, a syringe serving as a reservoir for the drug, and means for expelling drug from the syringe. The syringe is connected to the base member such that the longitudinal axis of the syringe is substantially parallel to the skin surface. A delivery needle is in communication with the syringe. The needle has an angled bend which directs the tip of the needle substantially perpendicular to the skin-contacting surface. In use, the tip of the needle is adapted to penetrate the skin of the subject.

Claims

1. A drug delivery device comprising a base member defining a skin-contacting surface for application to the skin of a subject, a syringe serving as a reservoir for a drug, a delivery needle coupled to said syringe, and means for expelling the drug out of the interior of said syringe and through said needle, said needle having a tip, said syringe having a longitudinal axis and being movably coupled to said base member from a first position to a second position, said longitudinal axis of said syringe when in said first position being at a first angle to said skin contacting surface, said longitudinal axis of said syringe when in said second position being at a second angle to said skin contacting surface, said needle having first portion extending along said longitudinal axis and an angled bend which directs said tip of said needle at an angle to said longitudinal axis, whereupon when said syringe is in said second position said tip of the needle is adapted to penetrate the skin of the subject.

2. The drug delivery device of claim 1 wherein said second angle is approximately zero degrees, whereupon said longitudinal axis is substantially parallel to said skin contacting surface when said longitudinal axis of said syringe is in said second position.

3. The drug delivery device of claim 1 wherein said syringe is pre-filled with the drug.

4. The drug delivery device of claim 1 additionally comprising a mounting member mounted along the length of the exterior of the needle at the angled portion thereof.

5. The drug delivery device of claim 4, wherein said mounting member is permanently affixed to the needle.

6. The drug delivery device of claim 5, additionally comprising a sealing sheath mounted on said mounting member.

7. The drug delivery device of claim 6, wherein said sealing sheath is removably mounted on said mounting member.

8. The drug delivery device of claim 1 wherein said syringe comprises a barrel and a piston located adjacent said reservoir within said barrel, and wherein said means for expelling the drug out of the interior of the syringe comprises driving means for driving said piston along the interior of said barrel.

9. The drug delivery device of claim 8, wherein said syringe and said driving means are mounted within a housing.

10. The drug delivery device of claim 9, additionally comprising a travel limiting mechanism to limit the maximum amount of travel of said piston along the length of said barrel to adjust the amount of the drug provided by the needle to the subject.

11. The drug delivery device of claim 8, wherein said driving means is disposed alongside said barrel.

12. The drug delivery device of claim 8, wherein said driving means comprises a gas generator.

13. The drug delivery device of claim 12, additionally comprising a tube in communication between said gas generator and said piston.

14. The drug delivery device of claim 12, additionally comprising a housing for said syringe, said base member being movably coupled to said housing, and wherein relative motion of said housing towards said base member causes activation of said gas generator.

15. The drug delivery device of claim 8, additionally comprising a travel limiting mechanism to limit the maximum amount of travel of said piston along the length of said barrel to adjust the amount of the drug provided by the needle to the subject.

16. The drug delivery device of claim 1, wherein said tip of said needle extends approximately perpendicularly to said longitudinal axis.

17. The drug delivery device of claim 16, additionally comprising a flexible pull tab coupled to said sealing sheath.

18. The drug delivery device of claim 17 additionally comprising a release liner coupled to said skin contacting surface of said base member and to said sealing sheath.

19. The drug delivery device of claim 18, wherein said pull tab is arranged to be pulled away from said base member, and said release liner is arranged to be pulled away from said skin contacting surface of said base member, whereupon said sealing sheath is detached from said mounting member to expose said needle tip.

20. The drug delivery device of claim 1, wherein said base member is pivotally mounted with respect to said syringe.

21. The drug delivery device of claim 20 additionally comprising a housing, and wherein said syringe is located within said housing and said base member is pivotably coupled to said housing.

22. The drug delivery device of claim 21, additionally comprising a removable locking member which prevents relative movement of said base member towards said housing following removal of said sealing sheath and said release liner, whereupon said needle is retained within said housing until skin penetration is required.

23. The drug delivery device of claim 22, wherein said removable locking member comprises a semi-rigid safety tab.

24. The drug delivery device of claim 22, wherein movement of said base member relative to said housing is initially prevented by said removable locking member.

25. The drug delivery device of claim 24, wherein said means for expelling the drug out of said interior of said syringe comprises gas driving means and wherein the presence of said removable locking member also prevents said gas driving means from being actuated.

26. The drug delivery device of claim 22, wherein said removable locking member comprises a laminar member inserted between said base member and said housing.

27. The drug delivery device of claim 22, additionally comprising a travel limiting mechanism to limit the maximum amount of travel of said piston along the length of said barrel to adjust the amount of the drug provided by the needle to the subject.

28. The drug delivery device of claim 21, wherein relative motion of said housing towards said base member causes said needle tip to penetrate the skin.

29. The drug delivery device of claim 21, wherein said base member is movable relative to said housing between a first position in which said needle is retracted from the exterior of said device and a second position in which said tip of said needle protrudes from said device for penetration of the skin, said device further comprising means for locking the device in said first position after a single reciprocation of said device from said first position to said second position and back to said first position.

30. The drug delivery device of claim 29, wherein said locking means comprises a mechanical latch which is brought into operation by said reciprocation.

31. The drug delivery device of claim 30, wherein said latch comprises a pair of elements mounted on said base member and said housing, respectively, said elements being shaped such that they can have two relative configurations when the base member is in said first position relative to said housing, one of said configurations being a movable configuration in which said elements are mutually movable, and the other of said configurations being a locked configuration in which said elements are prevented from mutual movement, and wherein reciprocation of said base member and said housing with respect to each other causes said elements to pass from said first movable configuration, through an intermediate configuration when said base member is in said second position relative to said housing, and then to said locked configuration, thereby preventing any further movement of said base member relative to said housing.

32. The drug delivery device of claim 31, wherein one of said elements includes a projection and the other of said elements includes a recess which is adapted to receive said projection elements, said recess and said projection being spaced apart from each other in said movable configuration, and being in engagement with each other in said locked configuration.

33. The drug delivery device of claim 29, additionally comprising a travel limiting mechanism to limit the maximum amount of travel of said piston along the length of said barrel to adjust the amount of the drug provided by the needle to the subject.

34. The drug delivery device of claim 1, additionally comprising a release valve, and wherein said means for expelling the drug out of the interior of said syringe comprises gas driving means producing a gas and wherein following delivery of the drug through said needle, any residual gas is vented through said release valve.

35. The drug delivery device of claim 1, wherein means are provided for enabling a user to determine that delivery of the drug has been completed.

36. The drug delivery device of claim 1, wherein said syringe comprises a barrel coupled to an end piston and to an internal piston so as to allow for mixing of the drug in a lyophilised form with a diluent, said internal piston initially dividing the interior of said barrel into a diluent compartment and a drug compartment.

37. The drug delivery device of claim 36, wherein said means for expelling the drug out of said interior of said syringe comprises a gas generator for providing gas under pressure and wherein the gas pressure is transmitted through said diluent compartment so as to push said internal piston into said drug compartment allowing for ingress of the diluent into said drug compartment.