Device for containing and opening a glass ampule and for transferring liquid within the ampule to a container

• US 5,393,497 A
• Filed: 01/24/1994
• Issued: 02/28/1995
• Est. Priority Date: 09/21/1992
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Foster, Clark B., Smedley, William H., Haber, Terry M.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Freed, Rachel
• Application Number:
  US08/187,369
• Time in Patent Office: 400 Days
• Field of Search: 73/864.82, 137/68.1, 206/528, 206/532, 206/219, 206/446, 206/438, 604/82, 604/83, 604/87, 422/103, 422/99
• US Class Current: 422/554
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: Y10T 137/1632 Destructible element

Abstract

A device (2) used to transfer the liquid contents (156) of a glass ampule (8) to a vial (10) includes a telescoping ampule body (12, 14) defining a collapsible, substantially air-tight region (22) within which the ampule is housed, which collapses when one part (12) is threaded onto the other part (14). This collapse increases the pressure within the collapsible region housing the ampule. The ampule is broken within the region, such as at the end of the collapsing of the telescoping members by snapping off the tip (64) of the ampule and breaking the base (48, 53) of the ampule. When used with a vial, a vial (10) is mounted to the ampule body via a vial body (80, 92). A vial spike (120) passes through the vial septum (128). The ampule body and the vial body defines a flow path (74, 100) between the vial spike and the ampule region. Once the flow path is open, the liquid from the ampule within the region flows along the flow path and into the vial because of the pressure created within the region.

Claims

1. A device for containing and opening a glass ampule containing a liquid, and for transferring a portion of the liquid to the interior of a container, the ampule including a base, a tip and a neck therebetween, the device comprising;

an ampule containing a liquid and having a base, a tip, and a neck therebetween;

a container having an interior containing a pharmaceutical component, the pharmaceutical component being a substrate other than the liquid;

means for increasing the pressure in the region to a pressure above ambient pressure

a body to which the container is mountable;

means, coupled to the body, for housing the ampule in a region;

means for breaking the ampule so that the liquid in the ampule flows into the region;

means for fluidly coupling the region to the interior of the container along a flow path so that the liquid in the region flows into the interior of the container; and

a pierceable septum positioned along the fluid path for fluidly accessing the interior of the container, the pierceable septum being exposed so that a syringe may be used to pierce the septum and extract a liquid mixture from the container.

18. The device of claim 1 wherein:

the fluidly coupling means includes a pierceable septum positioned along the flow path.

19. The device of claim 18 wherein:

the flow path is defined in part by a hollow valve spike having a sharpened end, used to pierce the septum, and an exit end.

20. The device of claim 19 wherein:

the flow path includes a check valve which permits fluid flow from the region to the interior of the container but prevents fluid flow from the interior of the container to the region.

21. The device of claim 20 wherein:

the check valve includes a flap of flexible material positioned adjacent the hollow valve spike at the exit end.

22. The device of claim 19 wherein:

the flow path is defined in part by a hollow vial spike having a sharpened vial end and an entrance end.

23. The device of claim 22 wherein:

the exit end and the entrance end open into a common region.

2. A method for transferring at least a portion of a liquid contained within a glass ampule to the interior of a container, the ampule including a base, a tip and a neck therebetween, the method comprising the following steps:

housing an ampule in a region of a body, the ampule containing a liquid;

coupling a container to the body, the container having an interior containing a pharmaceutical component, the interior of the container occupying a space which is independent and separate from the region in which the ampule is housed;

increasing the pressure in the region to a pressure above ambient pressure;

breaking the ampule so that the liquid in the ampule flows into the region; and

fluidly coupling the region to the interior of the container along a flow path so that the liquid in the region flows into the interior of the container under the influence of the pressure above ambient pressure.

3. The method of claim 2 wherein:

the pressure increasing step is carried out with a telescoping structure and collapsing the telescoping structure over the ampule to create a positive pressure within the region.

4. The method of claim 2 wherein:

the ampule breaking step includes snapping off the tip of the ampule and breaking the base of the ampule.

5. The method of claim 2 further comprising:

filtering the liquid as the liquid flows along the flow path.

6. The method of claim 2 further comprising:

preventing fluid flow along the flow path from the container to the region.

7. The method of claim 2 further comprising:

fluidly accessing the interior of the container through a syringe septum positioned along the flow path while the container remains coupled to the body; and

preventing a fluid flow from the region to the second position along the fluid path during fluidly accessing of the interior of the container.

8. A device for opening a glass ampule, containing a liquid, and transferring at least part of the liquid to a vial, the ampule including a tip, a base, and a neck therebetween, the vial including a pierceable vial septum and an interior containing a pharmaceutical component, the device comprising:

a vial including a pierceable vial septum and an interior containing a pharmaceutical component;

an ampule containing a liquid and having a base, a tip, and a neck therebetween;

a body defining a collapsible, substantially air-tight region therein, the ampule being housed within the region of the body, the body including first and second telescoping elements movable from an extended position to a collapsed position thereby reducing the size of the region so as to increase the pressure in the region;

means for breaking the ampule within the region;

a vial body, mountable to the body, including a vial spike for piercing the vial septum when the vial is mounted to the vial body; and

the body and the vial body defining a selectively openable flow path which is selectively opened so that the liquid in the region will flow from the region, through the flow path, through the vial spike and into the vial.

9. The device of claim 8 wherein:

the ampule breaking means includes an eccentric member carried by the first telescoping part and a post carried by the second telescoping part, the eccentric member engagable with the tip and the post engagable with the base of the ampule.

10. The device of claim 8 further comprising:

means for accessing the contents of the vial through the vial spike.

11. The device of claim 8 further comprising:

a filter along the flow path.

12. The device of claim 8 further comprising:

a one-way valve at a first position along the flow path.

13. The device of claim 12 further comprising:

a syringe access device including a syringe septum at a second position along the flow path between the first position and the vial spike to permit fluid access to the vial through said syringe septum.

14. An ampule containing, opening and transferring device comprising:

an ampule containing a liquid, the ampule having a base, a tip, and a neck therebetween;

a container having an interior containing a pharmaceutical component, the pharmaceutical component being a substance other than the liquid;

a body to which the container is mountable;

means, coupled to the body, for housing the ampule in a region;

means for increasing the pressure in the region to a pressure above ambient pressure;

means for breaking the ampule so that the liquid in the ampule flows into the region;

means for fluidly coupling the region to the interior of the container along a flow path so that the liquid in the region flows into the interior of the container under the influence of the pressure above ambient pressure thereby mixing the liquid and the pharmaceutical component; and

means for filtering a fluid flow along the flow path.

15. The device of claim 14 wherein:

the pressure increasing means includes a telescoping element, mountable over the ampule, movable from an extended position to a collapsed position so that the volume of the region decreases thereby increasing the pressure within the region to the pressure above ambient pressure.

16. The device of claim 15 wherein:

the ampule breaking means includes means, carried by the telescoping element, for applying a lateral force on the ampule as the telescoping element moves from the extended position to the collapsed position.

17. The device of claim 16 wherein:

the ampule breaking means includes means for breaking a base of the ampule as the telescoping element moves from the extended position to the collapsed position.