The invention relates to liquid drug transfer devices in general and liquid drug transfer devices including a vial adapter in particular.
Liquid drug reconstitution assemblages with an irremovable injection vial are known in the art. The term “irremovable” implies an injection vial after attachment to a liquid drug transfer device cannot be detached without damaging one or both of the liquid drug transfer device and the injection vial. One approach involves preventing detachment of an injection vial by preventing access thereto. Another approach involves sufficiently securely pre-attaching an injection vial to preclude detachment.
US Patent Application Publication No. US 2008/0015496 entitled Safety Device For a Bottle For Medical Use employs the former approach. The safety device includes a chamber for completely covering a bottle during the use thereof and spring tabs with free ends directed towards the interior of the chamber. The safety device can be designed to transfer liquid drug from a bottle to an infusion bag or a needleless syringe.
Commonly assigned PCT International Application No. PCT/IL2014/050327 entitled Drug Container Closure for Mounting on Open Topped Drug Container to Form Drug Reconstitution Assemblage for use with Needleless Syringe published under WO 2014/170888 employs the latter approach. The drug reconstitution assemblage includes a tubular closure housing with snap fit members for securely mounting on an injection vial and a fluid transfer member having a puncturing cannula for displacement with respect to the tubular closure housing from an initial set-up position with a non-punctured intact injection vial to a subsequent flow communication position with a punctured injection vial for liquid drug reconstitution for administration purposes.
The present invention is directed toward liquid drug transfer devices having a similar vial adapter construction as the aforementioned US 2008/0015496 safety devices insofar as their vial adapters include activation vial retention flex members for vial retention purposes in an activation position puncturing the injection vial equivalent to the US 2008/0015496 spring tabs. The liquid drug transfer devices of the present invention differ from the aforementioned US 2008/0015496 safety devices insofar as their vial adapters additionally include set-up vial retention flex members for vial retention purposes in a set-up position without puncturing an injection vial. The vial adapters can be implemented in a wide range of liquid drug transfer devices for use with a needleless syringe, an infusion bag, and the like. The liquid drug transfer devices of the present invention can be supplied with a pre-attached injection vial in a set-up position to form a ready-to-use liquid drug reconstitution assemblage.
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 female vial adapter 30 includes a vial adapter 31 having a longitudinal vial adapter centerline 32 and a transverse vial adapter top wall 33 transverse thereto. The female vial adapter 30 includes a substantially cylindrical skirt 34 downwardly depending from the vial adapter top wall 33 for telescopically slidingly receiving the injection vial 20 therein. The skirt 34 preferably has the same height H1 as the injection vial 20 such that the injection vial 20 is flush with the skirt 34 on full insertion of the injection vial 20 thereinto in an activation position.
The vial adapter top wall 33 has a downward depending hollow puncturing cannula 36 for puncturing an injection vial 20 and an upright fluid transfer port 37 constituted by a female Luer connector in flow communication with the puncturing cannula 36. The puncturing cannula 36 has a puncturing cannula tip 38 with a flow aperture 39 for accessing an injection vial 20.
The skirt 34 includes a discrete vial retention flex member structure 41 mounted therein. The vial retention flex member structure 41 has a solid section 42 distal to the vial adapter top wall 33 and a slotted section 43 proximate to the vial adapter top wall 33. The solid section 42 is about a third of the height of the skirt 34. The slotted section 43 includes four equispaced spacers 44 for abutting against the vial adapter top wall 33, a diametric pair of activation vial retention flex members 46 proximal to the vial adapter top wall 33 and a diametric pair of set-up vial retention flex members 47 distal to the vial adapter top wall 33. The set-up vial retention flex members 47 are preferably orthogonal to the activation vial retention flex members 46.
The discrete vial retention flex member structure 41 can optionally include additional activation vial retention flex members 46 and additional set-up vial retention flex members 47 in which case the former 46 have a first radial arrangement with respect to the longitudinal vial adapter centerline 32 and the latter 47 have a second radial arrangement with respect to the longitudinal vial adapter centerline 32 different from the first radial arrangement.
Each activation vial retention flex member 46 has an upright section 46A ending at a free tip 46B inwardly inclined towards the longitudinal vial adapter centerline 32. The free tips 46B are separated from the vial adapter top wall 33 by a height slightly less than the vial crown's height H2 such that the activation vial retention flex members 46 urge the injection vial 20 against the vial adapter top wall 33 on full insertion of the injection vial 20 into the skirt 34.
Each set-up vial retention flex member 47 has an upright section 47A ending at a free tip 47B inwardly inclined towards the longitudinal vial adapter centerline 32. The free tips 47B are separated from the upright sections 46A by a height slightly less than the vial crown's height H2 such that the vial crown 23 is snugly disposed therebetween in the set-up position. The skirt 34 lightly secures the injection vial 20 in the set-up position and prevents inadvertent puncturing of the vial stopper 28. The injection vial 20 outwardly flexes the set-up vial retention flex members 47 against the skirt 34 on full insertion thereinto.
While particular embodiments of the present invention are illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention.
Filing Document | Filing Date | Country | Kind |
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PCT/IL2016/050782 | 7/18/2016 | WO | 00 |
Number | Date | Country | |
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62194489 | Jul 2015 | US |