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

• US 6,500,150 B1
• Filed: 06/23/1998
• Issued: 12/31/2002
• 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: Gross, Joseph, Lavi, Gilad, Tsals, Izrail
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): HAYES, MICHAEL J
• Application Number:
  US09/103,716
• Time in Patent Office: 1,652 Days
• Field of Search: 604/93, 604/110, 604/111, 604/192, 604/198, 604/233, 604/239, 604/263, 604/264, 604/131, 604/272
• US Class Current: 604/131
• 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 housing having an internal drug reservoir;

a drug delivery needle extending from the housing for penetration of the skin of a subject, the needle having an outlet for drug delivery;

a base member defining a skin-contacting surface for application to the skin of a subject, said base member being in pivotable relation to the housing between a first position in which the needle is concealed from the exterior of the device and a second position in which the delivery needle protrudes from the device for penetration of the skin, the device further comprising means for locking the device in the first position after a single reciprocation of the device from the first position to the second position and back to the first position.

2. A device according to claim 1, wherein a sealing sheath is provided with a flexible pull tab which extends through a release liner.

3. A device according to claim 2, wherein when the pull tab is pulled away from the base member, the release liner is pulled away from a lower surface of the base member and the sealing sheath is detached from a mounting member to reveal the needle tip.

4. A device according to claim 3, which is provided with a removable locking member which prevents relative movement of the base member towards the housing following removal of the sealing sheath and the release liner, thereby retaining the needle within the housing until skin penetration is required.

5. A device according to claim 4, wherein said removable locking member is a semi-rigid safety tab.

6. A device according to claim 4, wherein movement of the base member relative to the housing is initially prevented by said removable locking member.

7. A device according to claim 6, additionally comprising means for providing a gas for delivering a drug from the reservoir through the needle, and wherein the presence of said removable locking member also prevents the means for providing a gas from being actuated.

8. A device according to claim 6, wherein said removable locking member comprises a laminar member inserted between said base member and said housing.

9. A device according to claim 1, wherein the locking means comprises a mechanical latch which is brought into operation by said reciprocation.

10. A device according to claim 9, wherein said latch comprises a pair of elements mounted on the base member and the 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 the housing, namely a movable configuration in which the elements are mutually movable, and a locked configuration in which the elements are prevented from mutual movement, and wherein reciprocation of the base member and the housing causes the elements to pass from the first movable configuration, through an intermediate configuration when the base member is in said second position relative to the housing, and then to said locked configuration, thereby preventing any further movement of the base member relative to the housing.

11. A device according to claim 10, wherein one of said elements is provided with a recess which is adapted to receive a projection on the other of said elements, the recess and the projection being spaced apart from one another in the movable configuration, and being in engagement with one another in the locked configuration.

12. A device according to claim 1, additionally comprising means for providing a gas for delivering a drug from the reservoir through the needle and a release valve, and wherein following delivery of the drug through the needle, any residual gas is vented through said release valve.

13. A device according to claim 1, wherein the locking means comprises a mechanical latch which is brought into operation by said reciprocation.

14. A device according to claim 13, wherein said latch comprises a pair of elements mounted on the base member and the 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 the housing, namely a movable configuration in which the elements are mutually movable, and a locked configuration in which the elements are prevented from mutual movement, and wherein reciprocation of the base member and the housing causes the elements to pass from the first movable configuration, through an intermediate configuration when the base member is in said second position relative to the housing, and then to said locked configuration, thereby preventing any further movement of the base member relative to the housing.

15. A device according to claim 14, wherein one of said elements is provided with a recess which is adapted to receive a projection on the other of said elements, the recess and the projection being spaced apart from one another in the movable configuration, and being in engagement with one another in the locked configuration.

16. A device according to claim 1, wherein movement of the base member relative to the housing is initially prevented by a removable locking member.