Drug delivery system for administering an adjustable preset dose

• US 7,329,241 B2
• Filed: 02/14/2003
• Issued: 02/12/2008
• Est. Priority Date: 02/14/2003
• Status: Expired due to Fees

• Current Assignee: Valeant Pharmaceuticals North America LLC (Bausch Health Cos., Inc.)
• Original Assignee: Valeant Pharmaceuticals North America LLC (Bausch Health Cos., Inc.)
• Inventors: Jensen, David F., Sponsel, Mark R., Malone, Gregory D., Rossi, Joseph P., Horvath, Michael W.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/367,626
• Publication Number:
  US 20040162528A1
• Time in Patent Office: 1,824 Days
• Field of Search: 604/207, 604/208, 604/209, 604/210, 604/211, 604212-224, 604/187
• US Class Current: 604/208
• 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 adjustable dose drug delivery system comprising:

an outer housing;

an inner housing slidably and adjustably disposed within said outer housing and containing an inner housing distal end flange having a hole and located at a distal end;

a syringe containing a syringe tip located at a distal end, and containing a plunger having a stopper at a distal end and a plunger flange at a proximal end, wherein said syringe is fixably disposed within said inner housing, and wherein said syringe tip has a syringe tip aperture for transmitting a dose of a drug, and wherein said plunger is slidably and adjustably disposed on an inner surface of said syringe;

a plunger limiter attached to said outer housing and limiting an axial movement of said plunger flange; and

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

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

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

4. The system 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.

5. The system 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.

6. The system of claim 1, wherein the outer housing further comprises a dosage indicator.

7. The system 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.

8. The system 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.

9. The system of claim 1, wherein the plunger is substantially cylindrical in shape.

10. The system of claim 1, further comprising a grip connected to the outer housing.

11. The system of claim 10, wherein the grip is employed to adjust the amount of the dosage of the drug.

12. The system of claim 10, wherein the grip is employed to deliver the dosage to a patient.

13. The system of claim 1, further comprising a grip connected to the inner housing.

14. The system of claim 13, wherein the grip is employed to adjust the amount of the dosage of the drug.

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

16. The system of claim 1, further comprising a removable covering attached to the syringe.

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

18. The system 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.

19. The system of claim 18, 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.

20. The system of claim 1, wherein the drug comprises an anti-seizure medication.

21. The system of claim 20, wherein the anti-seizure medication consists essentially of diazepam.

22. The drug delivery system of claim 1, wherein said syringe tip is disposed within said hole of said inner housing distal end flange and protrudes out of a surface of said inner housing distal end flange.

23. The drug delivery system of claim 1, wherein said syringe tip bidirectionally transmits fluid through said syringe tip aperture.

24. The drug delivery system of claim 1, wherein said plunger limiter contains a plunger limiter aperture through which said plunger slidingly moves.

25. The drug delivery system of claim 1, wherein said drug delivery system is a single use, adjustable dose, drug delivery system.

26. The drug delivery system of claim 25, wherein said drug delivery system is a rectal drug delivery system.

27. A method for adjusting the dosage of a drug, the method comprising the steps of:

providing an outer housing, an inner housing, and a syringe containing a plunger, wherein said inner housing contains an inner housing distal end flange having a hole and located at a distal end, and wherein said syringe contains a syringe tip located at a distal end and a plunger having a stopper at a distal end and a plunger flange at a proximal end, and wherein said syringe tip has a syringe tip aperture for transmitting a dose of a drug, and wherein said plunger is slidably and adjustably disposed on an inner surface of said syringe;

inserting said syringe into said inner housing, wherein said syringe is fixably disposed within said inner housing;

inserting said inner housing into an outer housing having a plunger limiter, wherein said inner housing is slidably and disposed within said outer housing and;

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

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

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

28. The method of claim 27, wherein the inner housing further comprises a dosage indicator.

29. The method of claim 28, wherein the outer housing further comprises an opening for viewing the dosage indicator.

30. The method of claim 29, 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.

31. The method of claim 27, wherein the outer housing further comprises a dosage indicator.

32. The method of claim 27, the method further comprising the step of providing a predetermined number of dosages of the drug in increments ranging from approximately 0.1 ml to approximately 10 ml.

33. The method of claim 27, 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.

34. The method of claim 27, 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.

35. The method of claim 27, 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.

36. The method of claim 27, wherein the plunger is substantially cylindrical in shape.

37. The method of claim 27, wherein the method further comprises the step of connecting a grip to the outer housing.

38. The method of claim 37, wherein the method further comprises the step of employing the grip to adjust the amount of the dosage of the drug.

39. The method of claim 37, wherein the method further comprises the step of employing the grip to deliver the dosage to a patient.

40. The method of claim 27, wherein the method further comprises the step of connecting a grip to the inner housing.

41. The method of claim 40, wherein the method further comprises the step of employing the grip to adjust the amount of the dosage of the drug.

42. The method of claim 40, wherein the method further comprises the step of employing the grip to deliver the dosage to a patient.

43. The method of claim 27, wherein the method further comprises the step of attaching a removable covering to the syringe.

44. The method of claim 27, wherein the outer housing comprises two portions that are substantially cylindrical in shape.

45. The method of claim 27, 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.

46. The method of claim 45, 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.

47. The method of claim 27, 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.

48. The method of claim 27, 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.

49. The method of claim 27, wherein the drug comprises an anti-seizure medication.

50. The method of claim 49, wherein the anti-seizure medication consists essentially of diazepam.

51. The method claim 27, wherein said syringe tip is disposed within said hole of said inner housing distal end flange and protrudes out of a surface of said inner housing distal end flange.

52. The method of claim 27, wherein said syringe tip bidirectionally transmits fluid though said syringe tip aperture.

53. The method of claim 27, wherein said plunger limiter contains a plunger limiter aperture through which said plunger slidingly moves.