Liquid drug transfer devices for failsafe correct snap fitting onto medicinal vials

Liquid drug transfer devices including a vial adapter designed for failsafe correct snap fitting on a medicinal vial for ensuring flow communication with the vial's interior. The vial adapters include at least two non-adjacent vial retention flex members for snap fitting over a vial opening for vial retention purposes and at least two non-adjacent vial guidance flex members longer than their counterpart vial retention flex members for guiding a vial adapter with respect to a vial prior to snap fitting the vial adapter thereon.

FIELD OF THE INVENTION

The invention pertains to liquid drug transfer devices for snap fitting onto medicinal vials.

BACKGROUND OF THE INVENTION

Medimop Medical Projects Ltd., Ra'anana, Israel (www.medimop.com) supply liquid drug transfer devices for use with medicinal vials containing liquid or powder drug contents and having a vial opening stopped by a typically rubber stopper. Vials are typically available in 13/14 mm and 20 mm standard sizes, and often contain expensive drugs. The liquid drug transfer devices include inter alia vial adapters with single lumen puncturing spikes, vented vial adapters with dual lumen puncturing spikes, fluid control devices illustrated and described in commonly owned PCT International Publication No. WO96/29113, MIX2VIAL® fluid control devices illustrated and described in commonly owned U.S. Pat. No. 6,558,365 to Zinger et al., in-line MIXJECT® fluid control devices illustrated and described in commonly owned PCT International Publication No. WO 2005/105014, and the like. The liquid drug transfer devices are used by both professional users and also home users, for example, young users, visually impaired users, infirm users, and the like, for self-drug administration purposes in the home.

The liquid drug transfer devices include a plastic molded vial adapter with a generally cylindrical skirt for telescopically slidingly receiving a vial opening therein, an integrally formed hollow puncturing spike for puncturing the vial's stopper and having at least one flow aperture towards the puncturing spike's tip for accessing the vial's interior, and at least one access port in flow communication with the puncturing spike. The skirts typically include four or six flex members including at least two non-adjacent vial retention flex members with at least partially circumferentially extending inwardly protruding vial retention ribs for snap fitting over a vial opening for vial retention purposes. The vial retention flex members are designed such that vial adapters cannot be released from a medicinal vial after being snap fitted thereon for sterilization purposes. Flex members not employed for vial retention purposes have smooth inner surfaces for bearing against a vial opening for stabilization purposes. Such vial stabilization flex members are typically of the same length as their counterpart vial retention flex members but maybe shorter, for example, as shown in US Patent Application Publication No. 2003/0199847 to Akerlund et al.

Misalignment of a liquid drug transfer device with respect to a vial results in puncturing difficulties and in some instances its vial adapter's puncturing spike's tip being embedded in the vial's stopper, thereby precluding flow communication with the vial's interior. In such instances, notwithstanding that a vial contains a full dosage of medicament, it is necessarily discarded. It has been long recognized that inaccurate snap fitting of vial adapters on vials can be at least partially contributed to a problematic design feature of medicinal vials described hereinafter. Professional users of liquid drug delivery devices are generally aware of this design feature but are still prone to inaccurately snap fit a vial adapter on a vial due to time pressure, and the like. Home users of liquid drug delivery devices are often not even aware of the design feature and are therefore even more prone to inaccurately snap fit a vial adapter on a vial despite their best efforts.

SUMMARY OF THE INVENTION

The present invention is directed towards liquid drug transfer devices including a vial adapter designed for failsafe correct snap fitting on a medicinal vial for ensuring flow communication with the vial's interior. The vial adapters include at least two non-adjacent vial retention flex members for snap fitting on a vial opening for vial retention purposes and at least two non-adjacent vial guidance flex members longer than their counterpart vial retention flex members for guiding a vial adapter with respect to a vial prior to snap fitting the vial adapter thereon. The vial guidance flex members are designed such that they assist a user to correctly co-axially align a liquid drug delivery device with respect to a vial prior to the former's puncturing spike touches the latter's stopper. Moreover, the vial guidance flex members have the tendency to cause a user to more cautiously approach a snap fitting procedure, thereby considerably assisting in correct snap fittings.

FIGS. 1 and 2show a liquid drug transfer device10for failsafe correct snap fitting on a conventional medicinal vial11. The vial11has a longitudinal axis12, a bottle portion13containing a liquid drug14, a vial opening16, an upper peripheral shoulder15and a narrow neck17intermediate the upper peripheral shoulder15of the bottle portion13and the vial opening16. The vial opening16is stopped by a typically rubber stopper18. The stopper18has a circular head19and a downward depending tubular section21with a blind bore22having a cross section area A1in a transverse direction to the longitudinal axis12. The vial11is hermetically sealed by an aluminum band23with a rim24having an external diameter D1, and an axially directed peripheral surface26, and exposing a raised central area27of the stopper18. The stopper's central area27has a cross section area A2in a transverse direction to the longitudinal axis12where A2>A1. The design feature A2>A1contributes to misalignment of a vial adapter with respect to a vial for flow communication purposes because users are under the mistaken impression that they have a larger target area for puncturing purposes than they have in practice.

The liquid drug transfer device10includes a plastic molded vial adapter30having a longitudinal axis31, and an upright female Luer connector32for receiving a syringe (not shown) and integrally formed with the vial adapter30. The vial adapter30includes a top wall33transverse to the longitudinal axis31, and a substantially cylindrical skirt34for telescopically slidingly receiving the vial opening16therein. The skirt34includes three non-adjacent axially directed vial retention flex members36and three non-adjacent axially directed vial guidance flex members37resiliently elastically attached to the top wall33. The guidance flex members36,37form an exterior wall of the vial adapter30. The vial adapter30includes an integrally formed hollow puncturing spike38in flow communication with the female Luer connector32. The puncturing spike38has a tip39with a flow aperture41theretowards.

The vial retention flex members36have inside surfaces36A and outwardly taper to flex member tips36B with an internal diameter D2>D1and having a length L1relative to the top wall33. The inward surfaces36A are provided with circumferentially extending inwardly protruding vial retention ribs36C for snap fitting over the vial opening16for vial retention purposes. The puncturing spike's tip39downwardly extends slightly past the vial retention ribs36C such that the puncturing spike's flow aperture41resides in a vial's blind bore22on snap fitting the liquid rug transfer device10on a vial11. The vial guidance flex members37have straight inside surfaces37A and extend to flex member tips37B with an internal diameter D3where D2>D3>D1and having a length L2>L1relative to the top wall33. The flex member tips37B downwardly extend beyond the flex member tips36B such that the former contact a band's rim24before the puncturing spike's tip39contacts the vial's stopper18for positively guiding the liquid drug delivery device10in concentric alignment with the vial11.

The failsafe correct snap fitting of a liquid drug delivery device10on a vial11is now described with reference toFIGS. 3A to 3E: Users are prone to inaccurately align a liquid drug delivery device10with respect to a vial11either by off centering the liquid drug delivery device10(seeFIG. 3A) or approaching the vial11at an angle (seeFIG. 3B). The vial guidance flex members37assist a user to co-axially align the liquid drug delivery device10relative to the vial11such that its flex member tips37B simultaneously contact the band's rim24before its puncturing spike's tip39contacts the vial's stopper18(seeFIG. 3C). Initial depression of the liquid drug delivery device10towards the vial11causes the vial guidance flex members37to flex slightly outward as they travel along the aluminum band's peripheral surface26and the puncturing spike's tip39to approach the vial's stopper18before contacting same at about the same time that the inside surfaces36B under the vial retention ribs36C touch the band's rim24(seeFIG. 3D). Continued depression of the liquid drug delivery device10towards the vial11causes the vial guidance flex members37to slide over the band's peripheral surface19and the vial retention flex members36to snap fit over the vial opening16and the flow aperture41to be positioned midway along the stopper's blind bore22for effecting flow communication with the female Luer connector32(seeFIG. 3E). The vial guidance flex members37have a length and sufficient flexibility to extend radially outwardly beyond the upper peripheral shoulder15of the bottle portion13of the vial11, such that the inside surface37A of each vial guidance flex member37rests against the upper peripheral shoulder15and the tip37B of each vial guidance flex member37extends radially outwardly beyond the upper peripheral shoulder15and radially outwardly beyond a periphery33aof the top wall33of the vial adapter30.

FIG. 4shows a liquid drug transfer device similar50in construction and use as the liquid drug transfer device10and differing therefrom insofar that the former is vented and includes a vial adapter51with two non-adjacent axially directed vial retention flex members36and two non-adjacent axially directed vial guidance flex members37.

FIG. 5shows a MIXJECT® fluid control device60with a detachable vial adapter61similar to the vial adapter30for failsafe correct snap fitting on a medicinal vial.

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.