Medicament delivery device

• US 5,814,020 A
• Filed: 09/06/1996
• Issued: 09/29/1998
• Est. Priority Date: 09/11/1995
• Status: Expired due to Term

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Medical Technologies Ltd. (Perrigo Company PLC)
• Inventors: Gross, Joseph
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/708,230
• Time in Patent Office: 753 Days
• Field of Search: 604/83-89, 604/131, 604/132, 604/133, 604/141, 604/142, 604/145, 604/146, 604/147, 604/151, 604/153, 604/156, 604/157, 604/140
• US Class Current: 604/141
• 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 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure

Abstract

A medicament delivery device has a reservoir within a housing and means for driving medicament from the reservoir. The device is provided with a filling mechanism upon which a medicament container sealed by a penetrable stopper is mounted. The mechanism comprises an internal bore which accommodates an internal rod from which a needle projects. Needle is hollow and is in communication with the reservoir. In order to fill the reservoir, the container is pressed into the bore, causing the needle to pierce the stopper, the stopper abutting against the rod and acting as a piston to drive medicament from the container as the container is pushed into the bore and moves relative to the stopper. Thus, the reservoir can be filled with the sterile medicament which is stable when stored in the container, and the filling is easily accomplished without the use of a syringe. A further advantageous feature is provided by a delivery needle which is mounted on the periphery of the lower surface of the housing. This configuration allows the driving means to be located adjacent to the skin, thereby, providing a more stable temperature and more predictable operation of the device.

Claims

1. A medicament delivery device comprising a housing, a reservoir within the housing, a filling mechanism for the reservoir integral with the housing and gas generated means for driving the medicament from the filled reservoir, the filling mechanism being adapted to receive a container for the medicament, said container being sealed by a penetrable stopper, and the filling mechanism comprising means for penetrating the stopper, said penetrating means being in communication with the reservoir to allow the medicament to be transferred from the container to the reservoir via the filling mechanism.

2. A medicament delivery device according to claim 1, wherein the medicament is provided in the form of a solid material which is reconstituted to a liquid form prior to use of the device.

3. A medicament delivery device according to claim 2, wherein the medicament is provided as a lyophilised solid.

4. A medicament delivery device according to claim 3, wherein a portion of the housing is transparent or translucent thereby allowing visual inspection of the reservoir contents.

5. A medicament delivery device according to claim 4, wherein said cover is provided with a snap mechanism allowing it to snap between a first and a second position.

6. A medicament delivery device according to claim 1, wherein the housing has a skin-contacting surface, and further comprising a hollow needle communicating with the reservoir extending, in use, through the periphery of the skin-contacting surface.

7. A medicament delivery device according to claim 6, wherein the driving means is located intermediate the reservoir and the skin-contacting surface.

8. A medicament delivery device according to claim 7, wherein the driving means has a substantially flat configuration and is disposed parallel to the skin-contacting surface.

9. A medicament delivery device according to claim 6, wherein the skin-contacting surface is in the form of a cover attached to the housing, said cover being movable between first and second positions, the needle being concealed by said cover when the cover is in said first position, and the needle being exposed when the cover is in said second position.

10. A medicament delivery device according to claim 9, wherein said cover is mounted on the housing by a hinge mechanism.

11. A medicament delivery device according to claim 6, wherein the driving means is located immediately above the skin-contacting surface.

12. A medicament delivery device according to claim 1, wherein the gas generating apparatus is in the form of an electrolytic cell.

13. A medicament delivery device according to claim 12, wherein the electrolytic cell comprises upper and lower plates and an electrolyte intermediate said plates.

14. A medicament delivery device according to claim 13, wherein the electrolytic cell further comprises a battery.

15. A medicament delivery device according to claim 12, wherein the electrolytic cell comprises a reservoir for a liquid electrolyte bounded in part by a gas permeable, liquid impermeable membrane.

16. A medicament delivery device according to claim 15, wherein the electrolytic cell further comprises a battery.

17. A medicament delivery device according to claim 1, wherein the housing is provided with a bore which receives the container and the penetrating means is disposed on a stop within the bore, such that the stopper is penetrated and abuts against the stop when the container is pushed along the bore, the penetrated stopper acting as a piston to deliver the medicament from the container.

18. A medicament delivery device according to claim 17, wherein the penetrating means comprises a hollow needle and the stop is a rod extending within the bore, the needle communicating with the reservoir via a conduit extending internally of the rod.

19. A medicament delivery device according to claim 1, wherein the gas generating apparatus comprises two substances which when brought into contact react to generate a gas.

20. A medicament delivery device according to claim 19, wherein the substances are an acid and a base.

21. A medicament delivery device according to claim 1, wherein the driving means comprises a swellable gel.

22. A medicament delivery device according to claim 21, wherein the swellable gel swells on contact with a liquid and the driving means further comprises a container containing such a liquid, and means for bringing the liquid and gel into contact.

23. A medicament delivery device according to claim 1, wherein the container protrudes from the housing prior to use and moves to a recessed position within the housing when the reservoir is filled with the medicament.

24. A medicament delivery device according to claim 1, wherein the container is integral with the housing.

25. A medicament delivery device according to claim 1, wherein the container is separate from the housing and is mounted thereon prior to use.

26. A medicament delivery device according to claim 1, wherein the penetrating means penetrates partially into but not entirely through the stopper prior to use.

27. A medicament delivery device according to claim 1, wherein the medicament is selected from peptides, proteins, hormones, analgesics, anti-migraine agents, anti-coagulant narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, protaglandins and antidiuretic agents.

28. A medicament delivery device according to claim 1, wherein the medicament is provided in the form of a semi-solid material which is reconstituted to a liquid form prior to use of the device.

29. A medicament delivery device comprising a housing having a skin-contacting surface, a reservoir within the housing, a hollow needle, in hinged relation to the housing, communicating with the reservoir extending, in use, through the periphery of the skin-contacting surface, and driving means for driving a medicament from the reservoir to a patient via the needle.

30. A medicament delivery device according to claim 29, wherein the driving means comprises a gas generating apparatus.

31. A medicament delivery device according to claim 30, wherein the gas generating apparatus is in the form of an electrolytic cell.

32. A medicament delivery device according to claim 31, wherein the electrolytic cell comprises upper and lower plates and an electrolyte intermediate said plates.

33. A medicament delivery device according to claim 32, wherein the electrolytic cell further comprises a battery.

34. A medicament delivery device according to claim 31, wherein the electrolytic cell comprises a reservoir for a liquid electrolyte bounded in part by a gas permeable, liquid impermeable membrane.

35. A medicament delivery device according to claim 34, wherein the electrolytic cell further comprises a battery.

36. A medicament delivery device according to claim 30, wherein the gas generating apparatus comprises two substances which when brought into contact react to generate a gas.

37. A medicament delivery device according to claim 36, wherein the substances are an acid and a base.

38. A medicament delivery device according to claim 29, further comprising a filling mechanism for the reservoir integral with the housing, the filling mechanism being adapted to receive a container for the medicament, said container being sealed by a penetrable stopper, and the filling mechanism comprising means for penetrating the stopper, said penetrating means being in communication with the reservoir to allow the medicament to be transferred from the container to the reservoir via the filling mechanism.

39. A medicament delivery device according to claim 38, wherein the container is capable of sliding within the housing, and the stopper makes a leakproof sliding fit with the interior of the container.

40. A medicament delivery device according to claim 39, wherein the housing is provided with a bore which receives the container and the penetrating means is disposed on a stop within the bore, such that the stopper is penetrated and abuts against the stop when the container is pushed along the bore, the penetrated stopper acting as a piston to deliver the medicament from the container.

41. A medicament delivery device according to claim 40, wherein the penetrating means comprises a hollow needle and the stop is a rod extending within the bore, the needle communicating with the reservoir via a conduit extending internally of the rod.

42. A medicament delivery kit comprising:

(a) A medicament delivery device according to claim 38; and

(b) a container sealed by a penetrable stopper which stopper makes a leakproof sliding fit with the interior of the container.

43. A medicament delivery device according to claim 42, wherein the medicament is selected from peptides, proteins, hormones, analgesics, anti-migraine agents, anti-coagulant narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, protaglandins and antidiuretic agents.

44. A medicament delivery device according claim 38, wherein the container is integral with the housing.

45. A medicament delivery device according claim 38, wherein the container is separate from the housing and is mounted thereon prior to use.

46. A medicament delivery device according to claim 38, wherein the container protrudes from the housing prior to use and moves to a recessed position within the housing when the reservoir is filled with the medicament.

47. A medicament delivery device according to claim 38, wherein the penetrating means penetrates partially into but not entirely through the stopper prior to use.

48. A medicament delivery device according to claim 29, wherein the driving means is located intermediate the reservoir and the skin-contacting surface.

49. A medicament delivery device according to claim 48, wherein the driving means has a substantially flat configuration and is disposed parallel to the skin-contacting surface.

50. A medicament delivery device according to claim 49, wherein the driving means is located immediately above the skin-contacting surface.

51. A medicament delivery device according to claim 29, wherein the driving means comprises a swellable gel.

52. A medicament delivery device according to claim 51, wherein the swellable gel swells on contact with a liquid and the driving means further comprises a container containing such a liquid, and means for bringing the liquid and gel into contact.

53. A medicament delivery device according claim 29, wherein the medicament is provided in the form of a solid material which is reconstituted to a liquid form prior to use of the device.

54. A medicament delivery device according to claim 53, wherein the medicament is provided as a lyophilised solid.

55. A medicament delivery device according to claim 29, wherein the skin-contacting surface is in the form of a cover attached to the housing, said cover being movable between first and second positions, the needle being concealed by said cover when the cover is in said first position, and the needle being exposed when the cover is in said second position.

56. A medicament delivery device according to claim 55, wherein said cover is mounted on the housing by a hinge mechanism.

57. A medicament delivery device according to claim 56, wherein said cover is provided with a snap mechanism allowing it to snap between said first and second positions.

58. A medicament delivery device according to claim 55, wherein said cover is provided with a snap mechanism allowing it to snap between said first and second positions.

59. A medicament delivery device according claim 29, wherein a portion of the housing is transparent or translucent thereby allowing visual inspection of the reservoir contents.

60. A medicament delivery device according to claim 29, wherein the medicament is selected from peptides, proteins, hormones, analgesics, anti-migraine agents, anti-coagulant narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, protaglandins and antidiuretic agents.

61. A medicament delivery device according to claim 29, wherein the medicament is provided in the form of a semi-solid material which is reconstituted to a liquid form prior to use of the device.

62. A medicament delivery kit comprising:

(a) a medicament delivery device comprising a housing, a reservoir within the housing, a filling mechanism for the reservoir integral with the housing and gas generated means for driving the medicament from the filled reservoir, the filling mechanism being adapted to receive a container for the medicament, said container being sealed by a penetrable stopper, and the filling mechanism comprising means for penetrating the stopper, said penetrating means being in communication with the reservoir to allow the medicament to be transferred from the container to the reservoir via the filling mechanism; and

(b) a container sealed by a penetrable stopper which stopper makes a leakproof sliding fit with the interior of the container.

63. A medicament delivery kit according to claim 62, wherein the medicament is selected from peptides, proteins, hormones, analgesics, anti-migraine agents, anti-coagulant narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, protaglandins and antidiuretic agents.