User actuated liquid drug transfer devices for use in ready-to-use (RTU) liquid drug transfer assemblages

Liquid drug transfer device for use in a Ready-To-Use liquid drug transfer assemblage for establishing flow communication between a liquid source and an injection vial. The liquid drug transfer device includes an injection vial adapter for mounting on an intact injection vial having an injection vial stopper without puncturing same, a liquid source adapter for attachment to a liquid source, a dual ended liquid transfer member for flow communication with the liquid source and puncturing an injection vial stopper, a safety catch mechanism requiring an initial manual linear sliding extension for priming the liquid drug transfer device, an extension limit arrangement for limiting the linear sliding extension, and a snap fit securing arrangement for securing the liquid source adapter on the injection vial adapter after actuation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Section 371 of International Application No. PCT/IL2018/050336, filed Mar. 23, 2018, which was published in the English language on Oct. 4, 2018 under International Publication No. WO 2018/178971 A1, which claims priority under 35 U.S.C. § 119(b) to Israeli Application No. 251458, filed Mar. 29, 2017, the disclosures of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The invention relates to liquid drug transfer devices suitable for use in Ready-To-Use (RTU) liquid drug transfer assemblages.

BACKGROUND OF THE INVENTION

Ready-To-Use (RTU) liquid drug transfer assemblages include a liquid drug transfer device and at least one intact non-punctured injection vial attached thereto. Such RTU assemblages require a user actuation for puncturing an injection vial for enabling flow communication therewith. Such RTU assemblages can be generally classified into two types as follows: First, a liquid drug transfer device with a user removable injection vial. The liquid drug transfer device can be supplied with a pre-attached injection vial or alternatively a user attaches same in a telescopic snap fit mounting action as a prior step to user actuation for puncturing. And second, a liquid drug transfer device with an irremovable injection vial except by applying extreme force damaging the liquid drug transfer device and/or the injection vial. Such RTU arrangements are particularly beneficial for wide range of usage environments including inter alia home use, out-patient clinic use, and the like.

Commonly owned PCT International Application No. PCT/IL2010/000777 entitled Vial Assemblage with Vial and Pre-Attached Fluid Transfer Device and published under PCT International Publication No. WO 2011/039747 discloses RTU assemblages of the first type. The RTU assemblages include a fluid transfer device having a pre-attached removable injection vial for use with a needleless syringe. The fluid transfer devices include an elongated tubular flow member having a connector for sealing flow communication with a needleless syringe and a puncturing cannula for puncturing an injection. The puncturing cannula tip is embedded in an injection vial stopper. WO 2011/039747FIG. 9toFIG. 13disclose a fluid transfer device with a pull ring type safety catch mechanism. WO 2011/039747FIG. 14toFIG. 23disclose a fluid transfer device with a twist and depress safety catch mechanism.

Commonly owned PCT International Application No. PCT/IL2013/050721 entitled Liquid Drug Transfer Devices employing Manual Rotation for Dual Flow Communication Step Actuations and published under PCT International Publication No. WO 2014/033710 discloses RTU assemblages of both types for enabling flow communication between an injection vial and a liquid source in the form of another injection vial, an infusion liquid container, and the like. The RTU assemblages include liquid drug transfer devices employing different mechanical arrangements for converting manual rotation into a linear displacement for flow communication purposes. Suitable mechanical arrangements include inter alia a screw thread arrangement, a pin and track arrangement, and the like.

Commonly owned 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 and published under PCT International Publication No. WO 2014/170888 discloses RTU assemblages of the second type for use with a needleless syringe. The RTU assemblages include a fluid transfer member with an integral needleless syringe connector and a puncturing cannula. The fluid transfer member is manually disposed along a diametric inverted L-shaped track pair from an initial non-puncturing position to a puncturing position. The inverted L-shaped track pair includes one-way snap fit members to prevent a user returning the fluid transfer member to an earlier position and indicating progress of the user activation.

SUMMARY OF THE INVENTION

The present invention is directed towards liquid drug transfer devices for use in Ready-To-Use (RTU) liquid drug transfer assemblages. The liquid drug transfer devices include an injection vial adapter for telescopic mounting on a non-punctured injection vial having an injection vial stopper and an uppermost injection vial surface without puncturing same. An injection vial adapter can be designed to either enable or prevent removal of an injection vial. The liquid drug transfer devices include a liquid source adapter intended for flow communication with a range of liquid sources. Suitable liquid sources include inter alia a needleless syringe with a male connector, an infusion liquid container, and the like.

A liquid source adapter is mounted on an injection vial adapter and configured for telescopically receiving the injection vial adapter therein on a manual linear sliding compaction of a liquid drug transfer device from an initial pre-actuated height H1to a final actuated height H2where H2<H1. The liquid drug transfer devices each include a dual ended liquid transfer member with a puncturing tip for puncturing an injection vial stopper. A dual ended liquid transfer member can be either integral formed with a liquid source adapter or a discrete component interdisposed between a liquid source adapter and an injection vial adapter depending on an intended liquid source. The puncturing tip is deployed above an uppermost injection vial surface in a pre-actuated state of a liquid drug transfer device and punctures through the injection vial stopper in the actuated state.

The liquid drug transfer devices include an integral safety catch mechanism for precluding inadvertent user actuation leading to inadvertent puncturing an intact non-punctured injection vial. The safety catch mechanism requires an initial manual linear sliding extension for imparting a short extension of the liquid source adapter from the injection vial adapter for priming the liquid drug transfer device ready for a subsequent manual linear sliding compaction whereupon the liquid source adapter snugly receives the injection vial adapter therein. The compaction stroke is necessarily longer than the extension stroke because the compaction stroke includes causing the puncturing tip to puncture the injection vial stopper. The liquid drug transfer devices include an extension limit arrangement for limiting the extension of the liquid source adapter from the vial injection adapter on priming the safety catch mechanism from its initial pre-actuated state. The liquid drug transfer device includes a snap fit securing arrangement for securing the liquid source adapter on the injection vial adapter in the actuated state.

FIG. 1toFIG. 7show a Ready-To-Use (RTU) liquid drug transfer assemblage100including a user actuated liquid drug transfer device30A in a pre-actuated state and a pre-attached injection vial10. The injection vial10has a longitudinal injection vial centerline11and includes a closed end vial tube12, a tubular vial crown13having a crown opening14and a vial neck16intermediate the vial tube12and the vial crown13. The injection vial10includes a vial shoulder17intermediate the vial tube12and the vial neck16. The injection vial10includes an injection vial stopper18stopping the crown opening14and an uppermost injection vial surface19. The injection vial10can include powder contents requiring reconstitution to form a liquid drug. Alternatively, the injection vial10can include liquid contents requiring dilution for administration purposes.

The liquid drug transfer device30A has a longitudinal device centerline31and includes an injection vial adapter32for telescopic snap fit mounting on the injection vial10and a liquid source adapter33initially mounted on the injection vial adapter32in a pre-actuated state. The liquid drug transfer device30A includes a safety catch mechanism34for priming the liquid drug transfer device30A ready for actuation thereby preventing inadvertent user actuation to puncture the intact non-punctured injection vial10. The liquid drug transfer device30A includes an extension limit arrangement36for limiting linear sliding extension of the liquid source adapter33from the vial injection adapter32on priming the liquid drug transfer device30A. The liquid drug transfer device30A includes a snap-fit securing arrangement37for securing the liquid source adapter33on the injection vial adapter32in an actuated state.

The injection vial adapter32includes a transverse injection vial adapter top surface38and a downward depending injection vial adapter skirt39for telescopic mounting on the vial crown13. The downward depending injection vial adapter skirt39has a lowermost injection vial adapter skirt rim39A. The injection vial adapter top surface38has a throughgoing injection vial adapter top surface aperture41overlying the uppermost injection vial surface19. The injection vial adapter skirt39includes four longitudinal slits42forming a diametric resiliently flexible flex member pair43. The injection vial adapter skirt39includes a diametric resiliently flexible longitudinal directed flex member pair44orthogonal to the flex member pair43.

The flex member pair43each includes an inward directed protrusion46for snap fit under the vial crown13. The flex member pair43each includes a longitudinal slit pair47forming a central longitudinal directed flex securing member48constituting a component of both the extension limit arrangement36and the snap fit securing arrangement37. The flex securing members48each have a free end49flush with the injector vial adapter top surface38. The free ends49are formed with an outward directed protrusion51having an inclined leading surface52.

The diametric resiliently flexible longitudinal directed flex member pair44terminate at an inward directed hook53disposed toward the injection vial adapter top surface38.

The liquid source adapter33includes a cap-like member54having a transverse liquid source adapter top surface56and a downward depending liquid source adapter skirt57for telescopically receiving the injection vial adapter32therein in an actuated state of the liquid drug transfer device30A. The liquid source adapter33includes an integral dual ended liquid transfer member58having an upward liquid transfer member end59and terminating in a downward puncturing tip61for puncturing the injection vial stopper18for flow communication with the vial tube12. The upward liquid transfer member end59is constituted by an upright liquid drug access port62protruding from the liquid source adapter top surface56. The liquid drug access port62is preferably constituted by a female connector as shown for flow communication with a needleless syringe, a male connector, and the like.

The liquid source adapter skirt57has a lowermost liquid source adapter skirt rim63and is formed with a diametric cutaway pair64each with a resiliently flexible longitudinal directed flex member66terminating at an outward directed hook67adjacent with the liquid source adapter skirt rim63. The safety catch mechanism34includes a diametric safety catch pair68each being constituted by an inward directed hook53and an outward directed hook67.

The liquid source adapter skirt57includes a diametric extension limit aperture pair69adjacent the liquid source adapter skirt rim63and a diametric securing aperture pair71adjacent the liquid source adapter top surface56. The extension limit aperture pair69each has an uppermost transverse rim72and a lowermost transverse rim73.

The heights of the liquid drug transfer device30A at its three different states: pre-actuated state, intermediate primed state and actuated state are indicated between the female connector62and the lowermost injection vial adapter skirt rim39A. Accordingly, the liquid drug transfer device30A has a pre-actuated height H1(seeFIG. 5) greater than its actuated height H2(seeFIG. 12). The liquid drug transfer device30A has an intermediate primed height H3(seeFIG. 8) greater than its pre-actuated height H1wherein H3=H1+H4and H4is the height of the extension limit aperture pair69.

FIG. 5toFIG. 13show use of the liquid drug transfer device30A is as follows:

FIG. 5toFIG. 7show the liquid drug transfer device30A in a pre-actuated state at a height H1. The puncturing tip61overlies the uppermost injection vial surface19. The outward directed protrusion pair51are deployed at the uppermost transverse rim pair72. The flex member pair44are outwardly biased with respect to their non-flexed positions and the flex member pair66are inwardly biased with respect to their non-flexed positions such that the safety catch pair68are engaged. Accordingly, the safety catch mechanism34is operative for preventing an inadvertent user compaction of the liquid source adapter33towards the injection vial adapter32until after the priming of the liquid drug transfer device30A.

FIG. 8toFIG. 10show the liquid drug transfer device30A in an intermediate primed state at the primed height H3by virtue of an initial manual linear sliding extension denoted P for extending the liquid source adapter33from the injection vial adapter32being stopped by the outward directed protrusion pair51stopping against the lowermost transverse rim pair73. The manual linear sliding extension disengages the inward directed hook pair53and the outward directed hook pair67such that the flex member pair44and flex member pair66assume their non-flex positions, thereby releasing the safety catch mechanism34.

FIG. 11shows the beginning of a subsequent manual linear sliding compaction for compacting the liquid drug transfer device30A from its intermediate primed state towards its actuated state. The outward directed hook pair67contact the inward directed hook pair53thereby causing an instantaneous outwardly flexing of the flex member pair66and an instantaneous inward flexing of the flex member pair44until the inward directed hook pair53and the outward directed hook pair67pass each other whereupon the flex member pair44and flex member pair66revert to their non-flexed positions. The height difference H1−H2equals the displacement the liquid source adapter33has to travel from its pre-actuated state in which the puncturing tip61overlies the uppermost injection port surface19to its actuated state in which the puncturing tip61protrudes through the injection vial stopper18.

FIG. 12andFIG. 13show the liquid drug transfer device30A in its actuated state after a complete manual compaction denoted Q. The user compaction releases the outward directed protrusion pair51from the extension limit aperture pair69such that they slide on the inside surface of the cap-like member54towards the securing aperture pair71and urges the puncturing tip61though the injection vial stopper18for flow communication with the injection vial10. The outward directed protrusion pair51correspondingly snap into the securing aperture pair71in the actuated state thereby securing the actuated liquid drug transfer device30A. The flex member pair44and the flex member pair66are correspondingly substantially co-extensive.

FIG. 14toFIG. 16show a RTU liquid drug transfer assemblage200including a liquid drug transfer device30B having a similar construction as the liquid drug transfer device30A and therefore similar parts are likewise numbered. The latter30B differs from the former30A insofar as it is intended to be used with a liquid source also requiring a puncturing action. The liquid source can be in the form of an infusion liquid source, and the like. The liquid drug transfer device30B is shown implemented for flow connection with an infusion bag20having an injection port21and an administration port22.

The liquid drug transfer device30B includes a three component construction as opposed to the liquid drug transfer device30A's two component construction. The liquid drug transfer device30B includes an injection vial adapter81, a liquid source adapter82and a discrete dual ended liquid transfer member83interdisposed between the injection vial adapter81and the liquid source adapter82. The dual ended liquid transfer member83includes an upward liquid transfer member end84also terminating in a puncturing tip similar to the puncturing tip61. The dual ended liquid transfer member83includes an intermediate circular flange86.

The injection vial adapter81includes an upward sleeve87mounted on the injection vial adapter top surface38for supporting the circular flange86in the liquid drug transfer device30B's pre-actuated state and the intermediate primed state. The upward sleeve87is formed with the diametric flex member pair44formed with the inward directed hooks53and the diametric flex securing member pair48.

The liquid source adapter top surface56is formed with an injection port connector89for slidingly receiving the injection port21and a diametric inward directed injection port stopper pair91for stopping the insertion of the injection port21therein. The upward liquid transfer member end84underlies the injection port21in the liquid drug transfer device30B's pre-actuated state.

The liquid drug transfer device30B has a pre-actuated height H1, an actuated height H2and an intermediate primed height H3similar to the liquid drug transfer device30A. The heights are indicated between the liquid source adapter top surface56and the lowermost injection vial adapter skirt rim39A. The height difference H1−H2equals the displacement that the liquid drug transfer device30B has to compact from its pre-actuated state in which the puncturing tip61overlies the uppermost injection port surface19and the upward liquid transfer member end84underlies the injection port21to its actuated state in which the puncturing tip61protrudes through the injection vial stopper18and the upward liquid transfer member end84punctures through the injection port21.

FIG. 17toFIG. 22show the use of the liquid drug transfer device30B with an injection vial10and an infusion bag20is as follows:

FIG. 17andFIG. 18show the liquid drug transfer device30B in a pre-actuated state at height H1. The puncturing tip61overlies the uppermost injection vial surface19. The puncturing tip84underlies the injection port connector21. The safety catch mechanism34prevents an inadvertent compaction. The outward directed protrusion pair51are deployed at the uppermost transverse rim pair72.

FIG. 19andFIG. 20show the liquid drug transfer device30B in an intermediate primed state at height H3after an initial manual linear sliding extension denoted P. The safety catch mechanism34is disengaged. The outward directed protrusion pair51stop against the lowermost transverse rim pair73.

FIG. 21andFIG. 22show the liquid drug transfer device30B in an actuated state at height H2after a subsequent manual compaction denoted Q. The puncturing tip61punctures though the injection vial stopper18for flow communication with the injection vial10. The puncturing tip84punctures the injection port21for flow communication with the infusion bag20thereby enabling flow communication between the infusion bag20and the injection vial10. The outward directed protrusion pair51snap into the securing aperture pair71.

FIG. 23toFIG. 25show a liquid drug transfer device30C also for use with the infusion bag20. The liquid drug transfer device30C has a similar construction and operation as the liquid transfer device disclosed in commonly owned PCT International Application No. PCT/IL2014/050680 entitled Liquid Transfer Devices for use with Infusion Liquid Containers and published under PCT International Publication No. WO 2015/019343FIG. 4andFIG. 5. The liquid drug transfer device30C includes a trifurcated body92having an IV spike93for sliding sealed insertion into an infusion bag's administration port, a substitute IV port94for sliding sealed insertion of an infusion set and an integral vial adapter96constituted by the liquid drug transfer device30A where the upward liquid transfer member end59is in continuous flow communication with the IV spike93and the substitute IV port94.

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.