Drug delivery system for administering an adjustable preset dose

• US 20040162528A1
• Filed: 02/14/2003
• Published: 08/19/2004
• Est. Priority Date: 02/14/2003
• Status: Active Grant

• Current Assignee: Valeant Pharmaceuticals North America LLC (Bausch Health Cos., Inc.)
• Original Assignee: Xcel Pharmaceuticals, Inc. (Bausch Health Cos., Inc.)
• Inventors: Horvath, Michael W., Jensen, David F., Sponsel, Mark R., Malone, Gregory D., Rossi, Joseph P.
• Granted Patent: US 7,329,241 B2
• Time in Patent Office: Days
• US Class Current: 604/207
• CPC Class Codes: A61M 2005/312 comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3154 limiting maximum permissible dose
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/31505 Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
• CPC Class Codes: A61M 5/31538 Permanent blocking, e.g. by medical personnel
• CPC Class Codes: A61M 5/31548 Mechanically operated dose setting member
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31555 by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• 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: A61P 25/12 for grand-mal

Abstract

An embodiment of the present invention provides an apparatus for setting a dose of a drug in a syringe having a plunger, comprising an outer housing and an inner housing adapted for encircling the syringe, such that the inner housing is positioned within the outer housing to set the dose of the drug. In an embodiment, the apparatus further comprises a dosage indicator disposed on the inner housing and the outer housing further comprises an opening for viewing the dosage indicator.

Claims

1. An apparatus for setting a dose of a drug in a syringe having a plunger, the apparatus comprising:

an outer housing;

an inner housing adapted for encircling the syringe; and

wherein the inner housing is positioned within the outer housing to set the dose of the drug.

2. The apparatus of claim 1, wherein the inner housing further comprises a dosage indicator.

3. The apparatus of claim 2, wherein the outer housing further comprises an opening for viewing the dosage indicator.

4. The apparatus of claim 2, further comprising

a locking assembly connected to the inner housing and the outer housing for fixing the relative positions of the inner housing and the outer housing;

wherein the dosage indicator is viewable through an opening in the outer housing.

5. The apparatus of claim 1, further comprising a dosage indicator disposed on the outer housing.

6. The apparatus of claim 2, wherein the dosage indicator provides a predetermined number of dosages of the drug in increments ranging from approximately 0.25 ml to approximately 10 ml.

7. The apparatus of claim 2, wherein the dosage indicator provides a predetermined number of dosages of the drug in increments ranging from approximately 0.5 mg to approximately 10 mg.

8. The apparatus of claim 1, further comprising a limiter attached to the inner housing for fixing at least one distance that the plunger can move within the syringe.

9. The apparatus of claim 1, further comprising a limiter attached to the outer housing for fixing at least one distance that the plunger can move within the syringe.

10. The apparatus of claim 1, wherein the plunger is substantially cylindrical in shape.

11. The apparatus of claim 1, further comprising a grip connected to the outer housing.

12. The apparatus of claim 11, wherein the grip is employed to adjust the amount of the dosage of the drug.

13. The apparatus of claim 11, wherein the grip is employed to deliver the dosage to a patient.

14. The apparatus of claim 1, further comprising a grip connected to the inner housing.

15. The apparatus of claim 14, wherein the grip is employed to adjust the amount of the dosage of the drug.

16. The apparatus of claim 14, wherein the grip is employed to deliver the dosage to a patient.

17. The apparatus of claim 1, further comprising a removable covering attached to the syringe.

18. The apparatus of claim 1, wherein the outer housing comprises two portions that are substantially cylindrical in shape.

19. The apparatus of claim 1, further comprising:

threadings disposed on the exterior of the inner housing; and

threadings disposed on the interior of the outer housing;

wherein the threadings on the inner and outer housing are slidably disposed within each other and the relative axial positions of the inner and outer housings are adjustable by rotation of the outer housing relative to the inner housing.

20. The apparatus of claim 19, wherein the threadings on the inner and outer housings are predetermined such that a desired predetermined dosage corresponds to a predetermined amount of rotation of the outer housing relative to the inner housing.

21. The apparatus of claim 1, further comprising a locking assembly attached to the inner housing and the syringe for fixing the relative positions of the syringe and the inner housing.

22. The apparatus of claim 1, further comprising a locking assembly connected to the inner housing and the outer housing for fixing the relative positions of the inner housing and the outer housing.

23. The apparatus of claim 1, wherein the drug comprises an anti-seizure medication.

24. The apparatus of claim 23, wherein the anti-seizure medication consists essentially of diazepam.

25. A single use, adjustable dose, rectal drug delivery system comprising:

an outer housing;

an inner housing adjustably disposed within the outer housing;

a syringe having a plunger and fixably disposed within the inner housing;

a plunger limiter attached to the outer housing; and

a locking assembly for adjusting the relative positions of the inner housing and the outer housing.

26. The system of claim 25, wherein the inner housing further comprises a dosage indicator.

27. The system of claim 26, wherein the outer housing further comprises an opening for viewing the dosage indicator.

28. The system of claim 25, wherein the outer housing further comprises a dosage indicator.

29. The system of claim 25, wherein the dosage indicator provides a predetermined number of dosages of the drug in increments ranging from approximately 0.25 ml to approximately 10 ml.

30. The system of claim 25, wherein the dosage indicator provides a predetermined number of dosages of the drug in increments ranging from approximately 0.5 mg to approximately 10 mg.

31. The system of claim 25, further comprising a limiter attached to the inner housing for fixing at least one distance that the plunger can move within the syringe.

32. The system of claim 25, further comprising a limiter attached to the outer housing for fixing at least one distance that the plunger can move within the syringe.

33. The system of claim 25, wherein the plunger is substantially cylindrical in shape.

34. The system of claim 25, further comprising a grip connected to the outer housing.

35. The system of claim 34, wherein the grip is employed to adjust the amount of the dosage of the drug.

36. The system of claim 34, wherein the grip is employed to deliver the dosage to a patient.

37. The system of claim 25, further comprising a grip connected to the inner housing.

38. The system of claim 37, wherein the grip is employed to adjust the amount of the dosage of the drug.

39. The system of claim 37, wherein the grip is employed to deliver the dosage to a patient.

40. The system of claim 25, further comprising a removable covering attached to the syringe.

41. The system of claim 25, wherein the outer housing comprises two portions that are substantially cylindrical in shape.

42. The system of claim 25, further comprising:

threadings disposed on the exterior of the inner housing; and

threadings disposed on the interior of the outer housing;

wherein the threadings on the inner and outer housing are slidably disposed within each other and the relative axial positions of the inner and outer housings are adjustable by rotation of the outer housing relative to the inner housing.

43. The system of claim 42, wherein the threadings on the inner and outer housings are predetermined such that a desired predetermined dosage corresponds to a predetermined amount of rotation of the outer housing relative to the inner housing.

44. The system of claim 25, wherein the drug comprises an anti-seizure medication.

45. The system of claim 44, wherein the anti-seizure medication consists essentially of diazepam.

46. A method for adjusting the dosage of a drug from a syringe having a plunger, the method comprising the steps of:

inserting the syringe into an inner housing;

inserting the inner housing into an outer housing having a plunger limiter;

adjusting the relative position of the inner housing and the outer housing;

fixing the relative position of outer housing to the inner housing; and

restricting the axial motion of the plunger by a plunger limiter.

47. The method of claim 46, wherein the inner housing further comprises a dosage indicator.

48. The method of claim 47, wherein the outer housing further comprises an opening for viewing the dosage indicator.

49. The method of claim 48, further comprising the steps of:

connecting a locking assembly to the inner housing and the outer housing for fixing the relative positions of the inner housing and the outer housing; and

viewing the dosage indicator through the opening in the outer housing.

50. The method of claim 46, wherein the outer housing further comprises a dosage indicator.

51. The method of claim 46, the method further comprising the step of providing a predetermined number of dosages of the drug in increments ranging from approximately 0.25 ml to approximately 10 ml.

52. The method of claim 46, the method further comprising the step of providing a predetermined number of dosages of the drug in increments ranging from approximately 0.5 mg to approximately 10 mg.

53. The method of claim 46, wherein the method further comprises the step of attaching a limiter to the inner housing for fixing at least one distance that the plunger can move within the syringe.

54. The method of claim 46, wherein the method further comprises the step of attaching a limiter to the outer housing for fixing at least one distance that the plunger can move within the syringe.

55. The method of claim 46, wherein the plunger is substantially cylindrical in shape.

56. The method of claim 46, wherein the method further comprises the step of connecting a grip to the outer housing.

57. The method of claim 56, wherein the method further comprises the step of employing the grip to adjust the amount of the dosage of the drug.

58. The method of claim 56, wherein the method further comprises the step of employing the grip to deliver the dosage to a patient.

59. The method of claim 46, wherein the method further comprises the step of connecting a grip to the inner housing.

60. The method of claim 59, wherein the method further comprises the step of employing the grip to adjust the amount of the dosage of the drug.

61. The method of claim 59, wherein the method further comprises the step of employing the grip to deliver the dosage to a patient.

62. The method of claim 46, wherein the method further comprises the step of attaching a removable covering to the syringe.

63. The method of claim 46, wherein the outer housing comprises two portions that are substantially cylindrical in shape.

64. The method of claim 46, further comprising the steps of:

providing threadings disposed on the exterior of the inner housing;

providing threadings disposed on the interior of the outer housing;

wherein the threadings on the inner and outer housing are slidably disposed within each other; and

adjusting the relative axial positions of the inner and outer housings by rotating the outer housing relative to the inner housing.

65. The method of claim 64, wherein the threadings on the inner and outer housings are predetermined such that a desired predetermined dosage corresponds to a predetermined amount of rotation of the outer housing relative to the inner housing.

66. The method of claim 46, wherein the method further comprises the step of attaching a locking assembly to the inner housing and the syringe for fixing the relative positions of the syringe and the inner housing.

67. The method of claim 46, wherein the method further comprises the step of attaching a locking assembly to the inner housing and the outer housing for fixing the relative positions of the inner housing and the outer housing.

68. The method of claim 46, wherein the drug comprises an anti-seizure medication.

69. The method of claim 68, wherein the anti-seizure medication consists essentially of diazepam.