This application is a Section 371 of International Application No. PCT/IL2013/050407, filed Oct. 17, 2012, which was published in the English language on Mar. 20, 2014, under International Publication No. WO 2014/041529 A1, and the disclosure of which is incorporated herein by reference.
The invention relates to drug vial adapters in general and female drug vial adapters in particular.
Commonly owned PCT International Application No. PCT/IL2006/000912 entitled Liquid Drug Transfer Devices for Failsafe Correct Snap Fitting onto Medicinal Vials and published under PCT International Publication No. WO 2007/017868 illustrates and describes liquid drug transfer devices including a drug vial adapter designed for guided alignment with a drug vial prior to snap fitting thereon and puncturing same for ensuring flow communication with the drug vial's interior. WO 2007/017868
A WO 2007/017868 drug vial adapter includes a top wall with a downward depending puncturing member and an opposite upright access port in flow communication with the puncturing member. The top wall is also formed with a downward depending generally cylindrical skirt surrounding the puncturing member. The generally cylindrical skirt includes at least four axially directed flex members longer than the puncturing member to avoid the puncturing member contacting a drug vial's drug vial stopper prior to alignment of the drug vial adapter and the drug vial. The axially directed flex members include two non-adjacent drug vial retention flex members for snap fitting over a drug vial opening for drug vial retention purposes and at least two non-adjacent drug vial guidance flex members longer than their counterpart drug vial retention flex members for guiding the drug vial adapter with respect to a drug vial prior to snap fitting thereon.
A WO 2007/017868 vented female drug vial adapter includes a dual lumen puncturing member having a liquid transfer lumen and a venting lumen. The liquid transfer lumen is in flow communication with a female connector for sealingly receiving a needleless syringe. The venting lumen is in flow communication with a generally circular air filter formed in the top wall. Inversion of the vented female drug vial adapter for aspiration of its liquid drug contents leads to liquid drug contents undesirably entering the venting lumen and wetting the air filter therefore considerably detracting from its ability to enable filtered air to pass therethrough for pressure equalization purposes during aspiration.
There is a need for female drug vial adapters for guided alignment relative to a drug vial prior to mounting thereon and puncturing but with a longer puncturing member.
The present invention is directed toward female drug vial adapters including a dual component construction having a spike component telescopically mounted on a skirt component for manual displacement from a set-up position to an actuated position for snug mounting on and puncturing a drug vial. Manual displacement of the spike component towards the skirt component affords initial guided alignment of the drug vial adapter relative to a drug vial prior to being snugly mounted thereon and puncturing same.
The present invention is particularly advantageous for vented female drug vial adapters which can be provisioned with a long puncturing member having a venting lumen with a venting lumen aperture at its puncturing tip. The vented female drug vial adapters are intended to be used with needleless syringes filled with a predetermined volume of liquid contents such that, on inversion of a vented female drug vial adapter mounted on a drug vial with liquid drug contents for aspiration purposes, the venting lumen aperture is above the liquid level of the liquid drug contents in a manner resembling a swimming snorkel. By virtue of this arrangement, liquid drug contents are precluded from entering the venting lumen and wetting the air filter.
In order to understand the invention and to see how it can be carried out in practice, a preferred embodiment will now be described, by way of a non-limiting example only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:
The drug vial 20 has a longitudinal drug vial axis 20A and includes a drug vial bottle 21 having a drug vial shoulder 22, a drug vial rim 23 and an intermediate narrow drug vial neck 24. The drug vial rim 23 defines a drug vial opening 26 sealed by a drug vial stopper 27 capped by a band 28. The drug vial 20 contains a powder drug 29 under negative pressure or a liquid drug 29.
The vented spike component 32 includes a transversely directed spike component top wall 36 having a circular air filter 37 and a pair of vent apertures 38. The vented spike component 32 preferably includes protective hoods 38 as illustrated and described in commonly owned PCT International Application No. PCT/2011/000187 entitled Liquid Drug Transfer Device with Vented Vial Adapter and published under PCT International Publication No. WO 2011/104712.
The spike component top wall 36 includes a downward depending dual lumen puncturing member 39 with a puncturing tip 41 for puncturing a drug vial stopper and an opposite upright female connector 42. The female connector 42 is preferably a female Luer connector with an external screw thread 43. The dual lumen puncturing member 39 includes a liquid transfer lumen 44 in flow communication with the opposite upright female connector 42. The dual lumen puncturing member 39 includes a venting lumen 46 having a venting lumen aperture 47 adjacent the puncturing tip 41 and in flow communication with the pair of vent apertures 38.
The spike component top wall 36 includes an uppermost spike component top wall surface 36A facing the upright female connector 42 and a lowermost spike component top wall surface 36B facing the dual lumen puncturing member 39. The puncturing member 39 has a length L1 defined between the lowermost spike component top wall surface 36B and the puncturing tip 41.
The spike component top wall 36 also includes a pair of opposite spaced apart downward depending spike component legs 48 lateral to the puncturing member 39. The spike component legs 48 terminate at leg tips 49 inwardly protruding toward the puncturing tip 41.
The skirt component 33 includes a transversely directed skirt component top wall 51 having a central aperture 52 and a downward depending substantially cylindrical skirt 53. The skirt 53 includes a multitude of drug vial flex members 54 defining a drug vial rim cavity 56 for snugly receiving the drug vial rim 23 therein and a skirt component margin 57 remote from the skirt component top wall 51. The drug vial flex members 54 preferably include inward directed projections 58 for snap fitting on the drug vial rim 23.
The skirt component top wall 51 includes an uppermost skirt component top wall surface 51A facing the spike component 32 and a lowermost skirt component top wall surface 51B facing the skirt 53. The skirt 53 has a length L2 defined between the uppermost skirt component top wall surface 51A and the skirt component margin 57.
Two opposite drug vial flex members 54A have leg tip apertures 59 for initially receiving the leg tips 49 for initially spacing the spike component top wall 36 from the skirt component top wall 51 with the puncturing member 39 protruding through the central aperture 52 in a set-up position of the telescopic female drug vial adapter 30. The drug vial flex members 54A are preferably formed with smooth outside surfaces 61 beneath the leg tip apertures 59 to enable smooth sliding movement of the legs tips 49 towards the skirt component margin 57.
In the set-up position, the lowermost spike component top wall surface 36B and the uppermost skirt component top wall surface 51A are separated by a length L3. In the set-up position, L1<L2+L3 such that the puncturing tip 41 does not protrude beyond the skirt component margin 57 which would lead to the puncturing tip 41 contacting a drug vial stopper 27 prior to correct alignment of the vented telescopic female drug vial adapter 30 with a drug vial 20. The puncturing member 39 and the skirt 53 are preferably dimensioned such that L1>L2 such that the venting tip aperture 47 protrudes beyond the skirt component margin 57 in the actuated position in which the spike component 32 fully abuts the skirt component 33.
The securing arrangement 34 includes a pair of opposite snap fit clips 62 orthogonal to the pair of opposite spike component legs 48.
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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221920 | Sep 2012 | IL | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IL2012/050407 | 10/17/2012 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2014/041529 | 3/20/2014 | WO | A |
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Number | Date | Country | |
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20150231034 A1 | Aug 2015 | US |