The invention relates to drug container closures for mounting on open-topped drug containers to form so-called ready-to-use drug reconstitution assemblages for use with needleless syringes. The drug container closures include a drug container stopper for sealing an open-topped drug container and a fluid transfer member with an integral needleless syringe connector and puncturing cannula.
Ready-to-use drug reconstitution assemblages including an open-topped drug container and a drug container closure having a fluid transfer member with an integral needleless syringe connector and puncturing cannula are known in the prior art. Exemplary prior art includes inter alia:
U.S. Pat. No. 4,576,211 to Valentini et al. entitled Safety device for connection of a syringe with the mouth or opening of a bottle containing a drug or a small tube for drug delivery from the syringe
U.S. Pat. No. 5,429,614 to Fowles et al. entitled Drug delivery system
U.S. Pat. No. 5,776,116 to Lopez et al. entitled Medical connector
U.S. Pat. No. 5,902,280 to Powles et al. entitled Aspiration needle apparatus incorporating its own vacuum and method and adapter for use therewith
U.S. Pat. No. 6,070,623 to Aneas entitled Connecting device in particular between a receptacle with a stopper capable of being perforated and a syringe
U.S. Pat. No. 6,382,442 to Thibault et al. entitled Plastic closure for vials and other medical containers
U.S. Pat. No. 6,478,788 to Aneas entitled Device for connection between a recipient and a container and ready-to-use assembly comprising such a device
U.S. Pat. No. 6,706,031 to Manera entitled Needleless access apparatus and system
U.S. Pat. No. 7,074,216 to Fowles et al. entitled Sliding reconstitution device for a diluent container
U.S. Pat. No. 7,195,623 to Burroughs et al. entitled Kit including side firing syringe needle for preparing a drug in an injection pen cartridge
U.S. Pat. No. 7,615,041 to Sullivan et al. entitled Vial adapter
U.S. Pat. No. 8,225,949 to Aneas entitled Plug device for a container and container provided with one such device
U.S. Pat. No. 8,480,646 to Nord et al. entitled Medical device connector
U.S. Pat. No. 8,562,582 to Tuckwell et al. entitled Reconstitution device
US Patent Application Publication No. 2012/0310203 entitled Apparatus and method
US Patent Application Publication No. 2013/0053814 entitled Device
There is a need for improved ready-to-use drug reconstitution assemblages including an open-topped drug container and a drug container closure mounted thereon.
The present invention is directed toward drug container closures for mounting on an open-topped drug container to form a so-called ready-to-use drug reconstitution assemblage for use with a needleless syringe.
The drug container closures include three major components as follows: a closure housing for securely mounting on an open-topped drug container, a drug container stopper securely mounted on the closure housing for sealing the drug container, and a fluid transfer member slidingly mounted on the closure housing. The fluid transfer member includes a needleless syringe connector integrally formed with a puncturing cannula for puncturing the drug container stopper and in flow communication with the needleless syringe connector.
The closure housing preferably includes a diametric inverted L-shaped track pair for guiding downward displacement of the fluid transfer member from an initial non-puncturing position to a final puncturing position. Alternatively, closure housings can be designed with a single inverted L-shaped track or three or more inverted L-shaped tracks.
The inverted L-shaped tracks are configured to require a user to perform two actions for guiding a fluid transfer member from its initial non-puncturing position to its final puncturing position as follows: An initial minor clockwise rotation for priming the drug reconstitution assemblage ready for activation and a subsequent major activation displacement for puncturing a drug container stopper. The inverted L-shaped tracks ensure a secure path precluding inadvertent pre-puncturing and include one-way snap members to prevent a user returning the fluid transfer member to an earlier position thereby affording tamper evidence. The one-way snap members also afford audible user indications for indicating to proceed to the next user action.
The drug container closures can have closure housings with either open or closed inverted L-shaped tracks. The former requires an additional sheath for hermetically sealing a downward depending puncturing cannula. The latter requires an additional sleeve exterior mounted on the closure housing for sealing the open tracks thereby precluding the need for the additional sheath.
The fluid transfer members can be provided in a vented version or a non-vented version. The needleless syringe connectors can be formed as a female Luer connector. The needleless syringe connectors can be formed as a swabbable self-sealing port for multiple aspirations of liquid drug contents.
In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:
The syringe 10 includes a barrel 11 with a plunger 12 and a male Luer lock connector 13. The syringe 10 can be formed with other types of male connectors. The syringe 10 is filled with a liquid component 14. The liquid component 14 can be diluent only. Alternatively, the liquid component 14 can include an active component.
The closure housing 32 is made from suitable plastic material and includes a diametric inverted L-shaped track pair 39 for guiding activation displacement of the fluid transfer member 34 from its initial non-puncturing position to its final puncturing position. The drug container closure 30 includes a sleeve 41 exterior to the closure housing 32 for sealing the diametric inverted L-shaped track pair 39 to ensure sterility of the puncturing cannula 37. The sleeve 41 includes snap fit members 42 for snap fitting onto the drug vial rim 23 on downward depression of the drug container closure 30 onto the drug vial 20 during assembly of the ready-to-use drug reconstitution assemblage 100.
The fluid transfer member 34 includes a circular base member 43 formed with the needleless syringe connector 36 and the puncturing cannula 37. The base member 43 includes a diametrical outward directed pin pair 44 for travelling along the diametric inverted L-shaped track pair 39 for guided activation displacement of the fluid transfer member 34. The fluid transfer member 34 optionally includes a venting arrangement 46 as disclosed in commonly owned WIPO International Publication No. WO 2011/104712 entitled Liquid Drug Transfer Device with Vented Vial Adapter.
The closure housing 32 includes a cross member 47 having a cross member upperside 47A and a cross member underside 47B and formed with a central aperture 48 for passage therethrough of the puncturing cannula 37. The cross housing underside 47B is integrally formed with the drug container stopper 33. The cross member 47 and the drug container stopper 33 can be overmolded together. Alternatively, the cross member 47 can be mechanically attached to the drug container stopper 33, swaged thereto, adhered thereto, and the like.
The inverted L-shaped tracks 39 each include an open-ended upright access leg 49 co-directional with the longitudinal centerline 31, a horizontal priming leg 51 transverse to the longitudinal centerline 31, and an upright activation leg 52 co-directional with the longitudinal centerline 31. The major upright activation leg 52 has a proximal activation leg end 52A and a distal activation leg end 54B correspondingly adjacent and distal to the priming leg 51.
The inverted L-shaped tracks 39 also each include three one-way snap members as follows:
An one-way retaining snap member 53 at a juncture 54 between the opended upright access leg 49 and the horizontal priming leg 51. The one-way retaining snap member 53 retains the fluid transfer member 34 in the closure housing 32 before use.
An one-way primed snap member 56 at a juncture 57 between the horizontal priming leg 51 and the proximal activation leg end 52A.
An one-way activated snap member 58 at the distal activation leg end 52B.
The use of the drug reconstitution assemblage 100 is now described with reference to
While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.
Number | Date | Country | Kind |
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225734 | Apr 2013 | IL | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IL2014/050327 | 4/3/2014 | WO | 00 |