Medicament conversion system

• US 5,791,466 A
• Filed: 09/06/1996
• Issued: 08/11/1998
• Est. Priority Date: 09/07/1995
• Status: Expired due to Fees

• Current Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Original Assignee: Elan Medical Technologies (Ireland) Ltd. (Perrigo Company PLC)
• Inventors: Tsals, Izrail
• Primary Examiner(s): Sewell, Paul T.
• Assistant Examiner(s): LUONG, SHIAN TINH NHAN
• Application Number:
  US08/709,486
• Time in Patent Office: 704 Days
• Field of Search: 206/219, 206/222, 206/568, 604/82, 604/83, 604/86, 604/87, 604/88, 604/416
• US Class Current: 206/222
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61J 1/201 having one piercing end
• 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

Abstract

A system for converting a medicament from a storage form to an administrable form comprises an evacuted medicament container, a container for a liquid, and means in the form of a hollow needle for establishing communication between said containers and thereby causing liquid to be drawn by suction from the liquid container to the medicament container. By establishing communication between an evacuated container and an unevacuated container, there is an instant, reliable and controlled addition of liquid to the medicament from the liquid container. The system has particular application to lyophilised medicaments.

Claims

1. A system for converting a medicament from a storage form to an administrable form, comprising:

a medicament container sealed under vacuum by a stopper;

a plug covering the stopper;

guide means supporting the plug;

a liquid container having liquid therein;

a hollow needle extending between the liquid container and the plug, the needle having a first end and a second sharpened end, the first end in communication with the liquid in the liquid container and the sharpened end embedded in the plug, whereby movement of the medicament container along the guide means towards the liquid container causes the sharpened end of the needle to pierce the plug and stopper thereby causing liquid to be drawn by suction from the liquid container to the medicament container, and separation of the medicament container from the liquid container and guide means after depletion of the liquid container, causes the sharpened end of the needle to become re-embedded in the plug thereby resulting in an emptied liquid container for safe disposal and a separate medicament container ready for administration.

2. A system according to claim 1, wherein the medicament container is removably mounted on said stopper.

3. A system according to claim 2, wherein the plug has an annular groove for receiving the medicament container and stopper.

4. A system according to claim 1, wherein the guide means is dimensioned so as to ensure that the sharpened end of the needle does not penetrate the stopper prior to use, and that the sharpened end of the needle is re-embedded into the plug after separation of the medicament container from the liquid container and guide means.

5. A system according to claim 1, wherein the liquid container comprises a collapsible vessel.

6. A system according to claim 1, wherein the medicament container comprises a glass vial.

7. A system according to claim 1, wherein the stopper is slidably removable from the interior of the container while preventing any liquid container in the container from leaking when the stopper is fully received into the interior of the container.

8. A system according to claim 1, wherein the stopper includes a groove on the surface thereof, whereby when the stopper is partially inserted into the container, the groove acts as a vapour path and which path is blocked by the total insertion of the stopper into the container.

9. A medicament container for use in a system according claim 1, comprising a container body having a medicament therein.

10. A medicament container according to claim 9, wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to dilute the medicament for subsequent injection.

11. The system according to claim 9, wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to suspend the medicament for subsequent injection.

12. The system according to claim 9, wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to dissolve the medicament for subsequent injection.

13. The system according to claim 1, wherein the stopper includes a groove on the interior surface thereof, whereby when the stopper is partially inserted into the container, the groove acts as a vapour path and which path is blocked by the total insertion of the stopper into the container.

14. The system according to claim 1 wherein the medicament is lyophilized.

15. The system according to claim 1 wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to reconstitute the medicament for subsequent injection.

16. A system according to claim 1, wherein the stopper includes a groove on a portion of the interior surface thereof, whereby when the stopper is partially inserted into the container, the groove acts as a vapour path and when the stopper is totally inserted into the container, the path of the groove is blocked.

17. A method for safely and efficiently converting a medicament from a storage form to an administrable form, comprising the steps of:

sealing under vacuum a medicament container by means of a stopper;

covering the stopper with a plug supporting the plug with a guide means;

providing a liquid container containing liquid therein, the liquid container having a hollow needle extending between the liquid container and the plug, the needle having a first blunt end, and a second, sharpened end, the blunt end in communication with the liquid in the liquid container and the sharpened end embedded in the plug;

moving the medicament container along the guide means towards the liquid container so that the sharpened end of the needle pierces the plug and stopper causing liquid to be drawn by suction from the liquid container to the medicament container; and

separating the medicament container from the liquid container and guide means after depletion of the liquid container thereby causing the sharpened end of the needle to become re-embedded in the plug, and resulting in an emptied liquid container for safe disposal and a separate medicament container ready for administration.

18. The method according to claim 17, wherein the medicament container is removably mounted on the stopper.

19. The method according to claim 17, wherein the medicament container is removably mounted on the plug.

20. The method according to claim 19, wherein the plug has an annular groove for receiving the medicament container and stopper.

21. The method according to claim 17, wherein the liquid container comprises a collapsible vessel.

22. The method according to claim 17, wherein the medicament container comprises a glass vial.

23. The method according to claim 17, wherein the medicament container is cylindrical and the stopper makes a leakproof sliding fit with the interior thereof.

24. The method according to claim 17, wherein the stopper includes a groove on the surface thereof, whereby when the stopper is partially inserted into the container, the groove acts as a vapour path and which path is blocked by the total insertion of the stopper into the container.

25. The method according to claim 17, wherein the stopper includes a groove on the interior surface thereof, whereby when the stopper is partially inserted into the container, the groove acts as a vapour path and which path is blocked by the total insertion of the stopper into the container.

26. The method according to claim 17, wherein the medicament container comprises a container body having a medicament therein.

27. The medicament container according to claim 26, wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to dilute the medicament for subsequent injection.

28. The medicament container according to claim 26, wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to suspend the medicament for subsequent injection.

29. The medicament container according to claim 26, wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to dissolve the medicament for subsequent injection.

30. The method according to claim 17 wherein the guide means is dimensioned so that the sharpened end of the needle does not penetrate the stopper prior to use, and that the sharpened end of the needle is re-embedded into the plug after separation of the medicament container from the liquid container and guide means.

31. The method according to claim 17 wherein the medicament is lyophilized.

32. The method according to claim 17 wherein the medicament is a solid or semi-solid and the interior of the sealed container body contains an effective volume of liquid required to reconstitute the medicament for subsequent injection.