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

• US 20020010423A1
• Filed: 04/17/2001
• Published: 01/24/2002
• Est. Priority Date: 06/16/1997
• Status: Active Grant

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Tsals, Izrail, Gross, Joseph
• Granted Patent: US 6,824,529 B2
• Time in Patent Office: Days
• 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 the drug and which is connected to the base member such that in use the longitudinal axis of the syringe is disposed substantially parallel to the skin-contacting surface;

a delivery needle in communication with the syringe, the needle having an angled bend which directs the tip of the needle substantially perpendicular to the skin-contacting surface such that in use the tip of the needle is adapted to penetrate the skin of the subject; and

means for expelling a drug out of the interior of the syringe.

2. A device according to claim 1, wherein the syringe is a prefilled syringe.

3. A device according to claim 1, wherein a mounting member is mounted along the length of the exterior of the needle at the angled portion thereof.

4. A device according to claim 3, wherein the mounting member is permanently affixed to the needle.

5. A device according to claim 3, wherein a sealing sheath is mounted on the mounting member.

6. A device according to claim 5, wherein the sheath is removably mounted on the mounting member.

7. A device according to any preceding claim, wherein means are provided for driving a piston along the interior of the syringe barrel.

8. A device according to claim 7, wherein the syringe barrel and the driving means are mounted within a housing.

9. A device according to claim 7, wherein the driving means is disposed alongside the syringe barrel.

10. A device according to claim 9, wherein the driving means is a gas generator.

11. A device according to claim 10, wherein a tube provides communication between the gas generator and a piston in the syringe.

12. A device according to claim 1, wherein the needle extends from the neck of the syringe barrel parallel to the longitudinal axis of the syringe and then bends to a substantially right angle, such that the tip of the needle points perpendicularly to the longitudinal axis of the syringe.

13. A device according to claim 12, wherein the sealing sheath is provided with a flexible pull tab which extends through a release liner.

14. A device according to claim 13, 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 the mounting member to reveal the needle tip.

15. A device according to claim 1, wherein the base member is pivotally mounted to a housing of the device.

16. A device according to claim 14, 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.

17. A device according to claim 16, wherein said removable locking member is a semi-rigid safety tab.

18. A device according to claim 15, wherein relative motion of the housing towards the base member causes activation of the gas generator.

19. A device according to claim 15, wherein relative motion of the housing towards the base member causes the needle tip to penetrate the skin.

20. A device according to claim 15, wherein the base member is displaceable relative 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.

21. A device according to claim 20, wherein the locking means comprises a mechanical latch which is brought into operation by said reciprocation.

22. A device according to claim 21, 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.

23. A device according to claim 22, 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.

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

25. A device according to claim 24, wherein the presence of said removable locking member also prevents the means for providing a gas from being actuated.

26. A device according to claim 24, wherein said removable locking member comprises a laminar member inserted between said base member and said housing.

27. A device according to claim 10, wherein following delivery of drug through the needle, any residual gas is vented through a release valve.

28. A device according claim 1, wherein means are provided for enabling a user to determine that delivery of drug has been completed.

29. A device according to claim 1, wherein the syringe barrel is provided with an end piston in addition to an internal piston so as to allow for mixing of a drug in a lyophilised form with a diluent, said internal piston initially dividing the interior of the syringe barrel into a diluent compartment and a drug compartment.

30. A device according to claim 10, wherein pressure resulting from the gas generator is transmitted through the diluent compartment so as to push the internal piston into the drug compartment allowing for ingress of diluent into said drug compartment.

31. A device according to claim 1, wherein a travel limiting mechanism is provided to limit the maximum amount of travel of the internal piston along the length of the syringe barrel so that the dose of drug can be adjusted to suit individual user needs.

32. A method for manufacturing and filling a drug delivery device comprising:

providing a base member having a skin-contacting surface, a syringe having drug therein and which is connected to the base member such that in use the longitudinal axis of the syringe is disposed substantially parallel to the skin-contacting surface, a delivery needle in communication with the syringe, the needle having an angled bend which directs the tip of the needle substantially perpendicular to the skin-contacting surface such that in use the tip of the needle is adapted to penetrate the skin of the subject; and

means for expelling a drug out of the interior of the syringe,

filling the syringe barrel with the drug under sterile conditions with the drug delivery path and the skin-contacting and skin-penetrating portions of the needle under sterile conditions and carrying out the remainder of the manufacturing and assembly steps in a clean area.

33. A method according to claim 32, wherein the sterility of the drug delivery path and the skin-contacting and skin-penetrating portions of the needle is achieved by securely affixing a mounting member along the exterior length of the needle under sterile conditions.

34. A method according to claim 32wherein the drug delivery path and the skin-contacting and skin-penetrating portions of the needle are sealed by means of a sheath mounted on the mounting member.

35. A method according to claim 32, wherein the external mounting member is used as a bending point when a right-angled needle is required.

36. A method according to claim 32, wherein sterilisation is achieved by steam sterilisation or gamma radiation.

37. 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 displaceable relative 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.

38. A method according to claim 37, wherein the base member is pivotally mounted to the housing.

39. A device according to claim 37, wherein the locking means comprises a mechanical latch which is brought into operation by said reciprocation.

40. A device according to claim 39, 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.

41. A device according to claim 40, 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.

42. A device according to claim 37, wherein movement of the base member relative to the housing is initially prevented by said removable locking member.

43. A method of delivering drug to a subject comprising the steps of:

providing a drug delivery device having a skin-contacting surface, a syringe having drug therein, and which is connected to the base member such that in use the longitudinal axis of the syringe is disposed substantially parallel to the skin contacting surface, a delivery needle in communication with the syringe, the needle having an angled bend, and means for expelling a drug out of the interior of the syringe;

applying the device to the skin of the subject; and

activating the device.

44. A method according to claim 43, wherein the tip of the delivery needle is substantially perpendicular to the skin contacting surface such that in use the tip of the needle is adapted to penetrate the skin of the subject.

45. A method according to claim 43, wherein the means for expelling the drug comprises a gas generator.

46. A method according to claim 43, wherein the syringe is prefilled.

47. A method according to claim 43, wherein the device is activated by moving the housing towards the base member.

48. A method according to claim 47, wherein the movement of the housing simultaneously causes the needle to penetrate the skin.

49. A method according to claim 43, further comprising the step of causing the device to lock into position after use whereby the needle tip is recessed within the housing.