Reconstituting device for injectable medication

• US 6,645,171 B1
• Filed: 03/16/1999
• Issued: 11/11/2003
• Est. Priority Date: 06/03/1996
• Status: Expired due to Term

• Current Assignee: Merck Serono SA (Merck & Co., Inc.)
• Original Assignee: Applied Research Systems ARS Holding NV (Merck & Co., Inc.)
• Inventors: Hobbs, Michael Anthony, Robinson, Grenville Arthur, Rowlands, Martyn Omar, Calvert, John Richard
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/194,873
• Time in Patent Office: 1,701 Days
• Field of Search: 604/82, 604/86-92, 604/200, 604/201, 604/411, 604/412, 604/413, 604/414, 604/415, 604/416
• US Class Current: 604/82
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• 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: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C

Abstract

A device for reconstituting liquid for medical use by bringing together a first liquid medium contained in a first vessel in the form of a cartridge (3) and a second medium, such as a drug in solid form, contained in a second vessel in the form of a vial (7), the device (19) comprising means (41) for supporting the first and second vessels, and a movable operating member (50) for applying a force to cause the first liquid medium to be delivered at a controlled rate from the first vessel into the second vessel. The first and second vessels may be provided in a pack (70) having liquid transfer means in the form of a needle (10).

Claims

1. A device for reconstituting liquid for medical use by bringing together a first liquid medium contained in a first vessel, the device comprising a support for the first and second vessels, a moveable operating member, and a driver for automatically moving the moveable operating member for applying a force to cause the first liquid medium to be delivered at a controlled rate from the first vessel into the second vessel, wherein the moveable operating member is reversibly operable to cause the combined first and second media to be delivered from the second vessel into the first vessel.

2. A device as claimed in claim 1, comprising a weight to provide the force to effect delivery.

3. A device as claimed in claim 1, comprising one or more springs to provide the force to effect delivery.

4. A device as claimed in claim 1, wherein movement of the movable operating member is controlled at least partly by the flow of gas via a restricted flow path.

5. A device as claimed in claim 1, comprising a housing which houses the support for the first and second vessels and the movable operating member.

6. A device as claimed in claim 1, wherein an arrangement of relatively movable coaxial tubular members is provided to guide the movement of the movable operating member.

7. A device as claimed in claim 1, wherein the movable operating member is arranged to engage a movable portion of the first vessel to urge the movable portion in an axial direction.

8. A device as claimed in claim 1, comprising an indicator for indicating the status of delivery.

9. A device as claimed in claim 8, wherein the indicator provides a visual indication of the position of the movable operating member.

10. A device as claimed in claim 1, combination with a pack removably insertable in the device.

11. A device and a pack as claimed in claim 10, wherein the pack includes the first vessel containing the first liquid medium, the second vessel containing the second medium, or both.

12. A device and a pack as claimed in claim 10, wherein the pack includes a liquid transfer device for transferring liquid from the first vessel into the second vessel, the liquid transfer device being shielded by a housing of the pack.

13. A device and a pack as claimed in claim 11, wherein the pack has a removable tamper evident cap.

14. A device and a pack as claimed in claim 10, wherein the device has an engagement member for engaging the pack to cause the first and second vessels to be placed in liquid communication.

15. Use of a device as claimed in claim 1, for reconstituting a pharmaceutical liquid.

16. Use as claimed in claim 15, for reconstituting a pharmaceutical liquid formulation comprising a drug and a diluent or carrier.

27. A pack as claimed in claim 1, arranged to hold the second vessel removably.

17. A kit for reconstituting a liquid for medical use by bringing together a first liquid medium contained in a first vessel and a second medium contained in a second vessel, the kit comprising a pack for holding the first and second vessels, and a device in which the pack is removably insertable, the kit being operable to bring the first liquid medium and the second medium together by transferring the first liquid medium from the first vessel to the second vessel and being operable to transfer the combined first and second media from the second vessel to the first vessel, wherein the pack is arranged to hold the first vessel removably so that, in use, after transfer of the first liquid medium from the first vessel to the second vessel and transfer of the combined first and second media from the second vessel to the first vessel, the first vessel may be removed from the pack together with the combined first and second media contained therein.

18. A kit as claimed in claim 17, wherein the device has an engagement device for engaging the pack to cause the first and second vessels to be placed in liquid communication.

19. A kit as claimed in claim 17, comprising a liquid communication device arranged to access the second vessel before it accesses the first vessel.

20. A pack for reconstituting a liquid for medical use by bringing together a first liquid medium contained in a first vessel and a second medium contained in a second vessel, the pack comprising a holder for the first and second vessels, a liquid transfer device for placing the vessels in liquid communication, said liquid transfer device including a first penetrating member for penetrating a closure of the second vessel, a second penetrating member for penetrating a closure of the first vessel, and a shield for shielding a user from the penetrating members before, during and after liquid reconstitution, wherein the pack further comprises protective members for the first and second penetrating members arranged such that when the first penetrating member and second vessel closure are brought together the first penetrating member penetrates both a protective member and the second vessel closure, and when the second penetrating member and the first vessel closure are brought together the second penetrating member penetrates both a protective member and the first vessel closure.

22. A pack as claimed in claim 20, wherein the protective members are sheaths on the first and second penetrating members.

23. A pack as claimed in claim 20, wherein the protective members are bungs.

24. A pack as claimed in claim 23, wherein the bungs are arranged to be pushed on e first and second penetrating members by the first and second vessels.

25. A pack as claimed in claim 24, comprising a vent for venting gas from the sterile environment around the first and second penetrating members when the bungs are pushed.

26. A pack as claimed in claim 20, wherein the liquid transfer device is arranged in a tubular housing for receiving the first vessel at one end and the second vessel at the opposite end.

21. A pack for reconstituting a liquid for medical use by bringing together a first liquid medium contained in a first vessel and a second medium contained in a second vessel, the pack comprising a holder for the first and second vessels, a liquid transfer device for placing the vessels in liquid communication, said liquid transfer device including a first penetrating member for penetrating a closure of the second vessel, a second penetrating member for penetrating a closure of the first vessel, wherein the first and second penetrating members are arranged to be maintained in a sterile environment at all times prior to penetration of the first and second vessel closures, and wherein the pack further comprises protective members for the first and second penetrating members arranged such that when the first penetrating member and second vessel closure are brought together the first penetrating member penetrates both a protective member and the second vessel closure, and when the second penetrating member and the first vessel closure are brought together the second penetrating member penetrates both a protective member and the first vessel closure.

28. A pack as claimed in claim 21, wherein the protective members are sheaths on the first and second penetrating members.

29. A pack as claimed in claim 21, wherein the protective members are bungs.

30. A pack as claimed in claim 29, wherein the bungs are arranged to be pushed onto the first and second penetrating members by the first and second vessels.

31. A pack as claimed in claim 30, comprising a vent for venting gas from the sterile environment around the first and second penetrating members when the bungs are pushed.

32. A pack as claimed in claim 21, wherein the liquid transfer device is arranged in a tubular housing for receiving the first vessel at one end and the second vessel at the opposite end.