Closed drug delivery system

• US 4,583,971 A
• Filed: 02/10/1984
• Issued: 04/22/1986
• Est. Priority Date: 02/10/1984
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Travenol European Research and Development Centre (Baxter International Inc.)
• Inventors: Kersten, Jean, Mathias, Jean-Marie, Pearson, Stephen, Goldhaber, Richard P., Bocquet, Jacques R.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/578,908
• Time in Patent Office: 802 Days
• Field of Search: 604/88, 604/89, 604/91, 604/87, 604/82, 604/414, 604/416, 604/403, 604/56, 206/219, 206/222, 141/329, 141/330
• US Class Current: 604/82
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/201 having one piercing end
• 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

Abstract

A sterile, closed drug delivery system (10) is provided comprising a flexible container (12), a capsule (22) coupled to the flexible container and a standard glass drug vial (36) positioned within the capsule. The flexible container has a liquid diluent therein. The capsule has supporting legs (32-35) which extend inwardly from the capsule to support the vial and also a highly flexible, pleated cap (28) which enables the drug vial to be manually moved relative to the supporting legs. The capsule is coupled to the flexible container by means of a hollow spike (54) located within the capsule and a frangible member (58) located within the flexible container, which frangible member allows fluid passage only when it is broken. Manual pressing of the pleated cap moves the drug vial downwardly onto the spike, piercing the stopper of the drug vial. Once the frangible member is broken, there is sterile communication between the drug vial and the liquid diluent contents of the flexible container.

Claims

1. A closed drug delivery system which comprises:

a flexible container having a liquid diluent therein, said flexible container having a delivery outlet;

a capsule including a relatively rigid wall coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means;

a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the drug vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the drug vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule.

2. A system as described in claim 1, said flexible container comprising a sealed vinyl container and said delivery outlet is at a lowest location of the container.

3. A system as described in claim 1, said capsule having a relatively rigid bottom and side walls, and said flexible means comprising a flexible member that is sealed at the top of the side walls, said flexible member being substantially deformable to enable manual downward movement thereof.

4. A system as described in claim 3, said flexible member including a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to the side walls adjacent the periphery of the flexible member.

5. A system as described in claim 3, said flexible member having a generally circular outline and said capsule carrying means for enabling hanging of the capsule.

6. A system as described in claim 1, said capsule having side walls formed in a generally circular configuration, and said flexible means comprising a generally circular flexible member sealed at the top of the side walls and being substantially deformable to enable manual downward movement thereof.

7. A system as described in claim 6, said flexible member including a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to the side walls adjacent the periphery of the flexible member.

8. A system as described in claim 1, said drug vial comprising a standard glass drug vial bottle having a pierceable stopper retained by a metal band, said communicating means comprising a spike for piercing said stopper when the vial is moved onto the spike.

9. A system as described in claim 1, said drug vial having a pierceable stopper, said communicating means comprising a spike for piercing said stopper when the vial is moved onto the spike.

10. A system as described in claim 1, said capsule having a bottom and side walls with said supporting means comprising a plurality of legs extending inwardly from the capsule.

11. A system as described in claim 10, said legs extending upwardly from the bottom of the capsule.

12. A system as described in claim 10, said legs extending radially inwardly from the side walls of the capsule.

13. A system as described in claim 1, said coupling means including a frangible member preventing fluid flow unless the frangible member is broken.

14. A system as described in claim 1, said capsule comprising a relatively rigid plastic housing and said flexible means comprising a plastic bellows cap sealingly covering the plastic housing, the plastic bellows cap being substantially deformable to enable manual downward movement thereof.

15. A system as described in claim 1, said flexible container, said capsule, and said coupling means having sterile interiors whereby the drug delivery system is sterile.

16. A closed drug delivery system which comprises:

a flexible container having a liquid diluent therein, said flexible container having a delivery outlet;

said flexible container comprising a sealed vinyl container and said delivery outlet being at a lowest location of the container;

a capsule coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means;

said capsule having a relatively rigid bottom and side walls, and said flexible means comprising a flexible member that is sealed at the top of the side walls, said flexible member being substantially deformable to enable manual downward movement thereof;

said flexible member including a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to the side walls adjacent the periphery of the flexible member;

said flexible member having a generally circular outline and said capsule carrying means for enabling hanging of the capsule;

a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible member;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule;

said drug vial having a pierceable stopper, said communicating means comprising a spike for piercing said stopper when the vial is moved onto the spike;

said supporting means comprising a plurality of legs extending inwardly from the capsule; and

said coupling means including a frangible member preventing fluid flow unless the frangible member is broken.

17. A drug delivery system which comprises:

a flexible container having a liquid diluent therein;

a capsule including a relatively rigid wall coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule.

18. A system as described in claim 17, said flexible container comprising a sealed vinyl container having a delivery outlet at a lowest location of the container.

19. A system as described in claim 17, said capsule having a relatively rigid bottom and side walls, and said flexible means comprising a flexible member that is sealed at the top of the side walls, said flexible means being substantially deformable to enable manual downward movement thereof.

20. A system as described in claim 19, said flexible member including a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to the side walls adjacent the periphery of the flexible member.

21. A system as described in claim 20, said flexible member having a generally circular outline and said capsule carrying means for enabling hanging of the capsule.

22. A system as described in claim 17, said capsule having side walls formed in a generally circular configuration, and said flexible means comprising a generally circular flexible member sealed at the top of the side walls and being substantially deformable to enable manual downward movement thereof.

23. A system as described in claim 17, including a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means, said drug vial comprising a standard glass drug vial bottle having a pierceable stopper retained by a metal band, said communicating means comprising a spike for piercing said stopper when the vial is moved onto the spike.

24. A system as described in claim 17, including a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means, said drug vial having a pierceable stopper, said communicating means comprising a spike for piercing said stopper when the vial is moved onto the spike.

25. A system as described in claim 17, said capsule having a bottom and side walls with said supporting means comprising a plurality of legs extending inwardly from the capsule.

26. A system as described in claim 17, said coupling means including a frangible member preventing fluid flow unless the frangible member is broken.

27. A system as described in claim 17, said capsule comprising a relatively rigid plastic housing and said flexible means comprising a plastic bellows cap sealingly covering the plastic housing, the plastic bellows cap being substantially deformable to enable manual downward movement thereof.

28. A drug delivery system which comprises:

a flexible container having a liquid diluent therein;

a capsule including a relatively rigid wall, coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means, said flexible means including a flexible member having a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to said wall adjacent the periphery of the flexible member, said flexible member being substantially deformable to enable manual downward movement thereof;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule.

35. A system as described in claim 28, further comprising a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means.

29. A drug delivery system which comprises:

a flexible container having a liquid diluent therein;

a capsule having side walls formed in a generally circular configuration, coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means, said flexible means including a generally circular flexible member having a plurality of pleats surrounding a planar central portion, with the flexible member being sealed to the side walls adjacent the periphery of the flexible member;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule.

36. A system as described in claim 29, further comprising a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means.

30. A drug delivery system which comprises:

a flexible container having a liquid diluent therein;

a capsule coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means, said supporting means including a plurality of legs extending inwardly from the capsule;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule.

31. A system as described in claim 30, said capsule further comprising a bottom and side walls.

32. A system as described in claim 31, said legs extending upwardly from the bottom of the capsule.

33. A system as described in claim 31, said legs extending radially inwardly from the side walls of the capsule.

37. A system as described in claim 30, further comprising a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means.

34. A drug delivery system which comprises:

a flexible container having a liquid diluent therein;

a capsule including a relatively rigid housing, coupled to said flexible container, said capsule having means for supporting a drug vial and flexible means for enabling movement of the drug vial relative to the supporting means, said flexible means including a plastic bellows cap sealingly covering the housing, the plastic bellows cap being substantially deformable to enable manual downward movement thereof;

means coupling said capsule to the interior of said flexible container, said coupling means including means for communicating with the interior of the drug vial, said communicating means being out of communication with the interior of the vial when the vial is in a first position supported by said supporting means, said communicating means being in communication with the interior of the vial when the vial has been moved relative to said supporting means and the vial is in another position within said capsule.

38. A system as described in claim 34, further comprising a drug vial having a drug therein adapted to be mixed with said diluent, said drug vial being supported by said supporting means and being adapted for engagement by said flexible means.