RECONSTITUTION DEVICE

• US 20100168712A1
• Filed: 05/24/2007
• Published: 07/01/2010
• Est. Priority Date: 05/25/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Tuckwell, Jonathan David, Arlett, Ben, Kivlin, Robert Owen, Palmer-Felgate, John Peter, Avery, Matthew Burgess, Schwan, Peter, Skinner, Kevin George, Dyer, Robert, Kadamus, Chris, Wood, Lee
• Granted Patent: US 8,562,582 B2
• Time in Patent Office: Days
• US Class Current: 604/406
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A reconstitution device for storing a first component of a pharmaceutical preparation includes a receptacle, a cap having a first end secured to the receptacle, a second end, and an inner bore having a central aperture. The device further includes a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated. The device also includes a plunger secured to the second end of the cap, a locking mechanism located in the cap, and an actuating mechanism. The actuating mechanism may prevent the device from inadvertent activation.

Claims

1. A reconstitution device comprising;

a receptacle;

a cap including a first end, a second end, and an inner bore having a central aperture, the first end being secured to the receptacle;

a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated;

a plunger secured to the second end of the cap;

a locking mechanism located in the cap; and

an actuating mechanism.

2. The device of claim 1, wherein the actuating mechanism comprises at least one protrusion on the cap and at least one indentation on the plunger, and wherein when the cap is rotated, the protrusion aligns with the indentation to allow the plunger to move in a downward direction.

3. The device of claim 2 further comprising a feedback mechanism for indicating to a user when the plunger has pierced the stopper.

4. The device of claim 3, wherein the feedback mechanism comprises a convex bump on each of the at least one protrusion on the cap, and a convex bump on each of the at least one indentation on the plunger.

5. The device of claim 2, further comprising a feedback mechanism for indicating to a user when the plunger has rotated such that the protrusion aligns with the indentation.

6. The device of claim 5, wherein the feedback mechanism provides tactile feedback and audible feedback.

7. The device of claim 1, wherein the plunger further comprises a shaft for perforating the stopper.

8. The device of claim 1, wherein the locking mechanism comprises a thin material including a tongue capable of flexing in a vertical direction.

9. The device of claim 8, wherein the tongue of the locking mechanism further comprises an aperture that is coaxially aligned with the shaft of the plunger.

10. The device of claim 1, wherein the receptacle includes an opening surrounded by a neck for attaching to the first end of the cap, the stopper being located in the opening of the neck.

11. The device of claim 10, wherein the first end of the cap is secured to the neck of the receptacle by a crimp ring.

12. The device of claim 10, wherein the first end of the cap is secured to the receptacle by a C-clip.

13. The device of claim 1, wherein the plunger further includes a male element for receiving a second receptacle.

14. The device of claim 13, wherein the male element includes an inner bore and an outer surface including a thread.

15. The device of claim 13, wherein the second receptacle is a syringe.

16. The device of claim 14, wherein the shaft of the plunger includes an in-line filtering mechanism and a channel for establishing communication between the inside of the receptacle and the inner bore of the male element.

17. The device of claim 1, further comprising a tamper-proof mechanism.

18. The device of claim 1, further comprising a top surrounding the plunger and the cap.

19. The device of claim 1, wherein the plunger is adapted to slide along the inner bore of the cap.

20. The device of claim 1, wherein the plunger is adapted to slide along an outer surface of the cap.

21. The device of claim 1, wherein the plunger has a top surface including direction markers and alignment markers.

22. The device of claim 1, wherein the top surface comprises a dome shape.

23. The device of claim 1, wherein the top surface is angled.

24. A reconstitution device comprising:

a receptacle having an opening surrounded by a neck;

a cap including a first end, a second end, and an inner bore having an aperture, the first end being secured to the receptacle;

a stopper located within the opening of the neck, the stopper including a portion capable of being perforated;

a plunger secured to the second end of the cap and being adapted to slide along the inner bore of the cap, the plunger having a shaft;

a locking mechanism located between the cap and the stopper for engagement with the shaft of the plunger; and

an actuating mechanism located on the plunger and the cap;

wherein when the actuating mechanism is activated, the plunger travels downwardly through the locking mechanism to perforate the stopper.

25. The device of claim 24, wherein the actuating mechanism comprises at least one protrusion on the cap and at least one indentation on the plunger, wherein when the cap is rotated, the protrusion aligns with the indentation to allow the plunger to move in a downward direction.

26. A reconstitution device comprising;

a receptacle;

a cap including a first end, a second end, and an inner bore having a central aperture, the first end being secured to the receptacle;

a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated;

a plunger secured to the second end of the cap, the plunger including a shaft for perforating the stopper;

a locking mechanism located on the plunger comprising a thin material including a tongue capable of flexing in a vertical direction and an aperture that is coaxially aligned with the shaft of the plunger; and

a feedback mechanism for indicating to a user when the plunger has perforated the stopper.

27. A method of assembling a reconstitution device comprising:

providing a receptacle having a lip surrounding an opening;

inserting a stopper into the opening of the receptacle;

providing a cap having a first end and including flexible legs, and a second end opposite the first end;

inserting a C-clip into an indentation at the first end of the cap;

sliding the first end of the cap over the stopper and the lip of the receptacle, wherein the C-clip allows the flexible legs to expand as the flexible legs pass over the lip, and allows the flexible legs to contract after passing over the lip to secure the cap to the receptacle.