Abstract: A connector assembly for a vial is disclosed. The connector assembly features a protective cap, a collar attachable to the rim of the vial, and a crimp cap for securing the collar to the rim. The collar features a flexible skirt provided adjacent the proximal end of the collar that is foldable about the underside portion of the vial rim. One or more ribs are provided adjacent a distal portion of the collar to seal against the stopper obturating the vial. The crimp cap can be supplied preattached to the collar in an uncrimped condition. When crimped, the crimp cap exerts a force against the distal end of the collar and the flexible skirt folded about the rim to secure the collar to the vial.

Abstract: The improved vial transfer assembly or vial transferset may be attached to a vial under sterile conditions and used to transfer fluid to or from a conventional vial. The transferset includes a tubular transfer member which is sealingly supported on the rim portion of a vial stopper, a piercing member having a piercing end reciprocally supported by an internal surface of the transfer member, a cap enclosing the tubular transfer member and a collar preferably formed of a malleable material which secures the assembly on the stopper, which is crimped beneath the vial rim. The piercing member has a generally longitudinal external channel which, upon piercing the planar portion of the stopper, establishes fluid communication with the vial through the tubular transfer member. The distal end of the tubular transfer member includes a Luer lock for establishing fluid communication to a syringe, IV set or the like.

Abstract: A lockable safety shield assembly for a prefillable syringe is provided. The design of the lockable safety shield assembly enhances pharmaceutical manufacturers' ease of assembling the various components as part of its filling or processing of the prefillable syringes in normal practice, while at the same time minimizes difficulties in mating parts made from different materials. A tube is placed around the outside surface of the syringe barrel and affixed thereto. A collar is provided on the tube adjacent the distal end of the syringe barrel. A safety shield is axially slidable over the tube between a retracted position, wherein the distal end of the piercing element associated with the prefillable syringe is exposed, and an extended position, wherein the safety shield is locked to the collar to protectively cover the distal end of the piercing element. The safety shield includes locking structure configured so that the shield can be easily fitted over the tube.

Abstract: A method and apparatus for attaching a connector assembly onto a vial is disclosed. The connector assembly features a protective cap, a collar attachable to the rim of the vial, and a crimp cap for securing the collar to the rim. A vial access device is contained within the collar. One or more ribs are provided adjacent a distal portion of the collar to seal against the stopper obturating the vial. The collar is provided with one or more slits which render the collar flexible in directions radial and axial to the central axis of the vial to compensate for variations in tolerances or dimensions present in the various components. The crimp cap can be supplied preattached to the collar in an uncrimped condition.

Abstract: A stopper assembly having by-pass features for use in a multi-chamber syringe barrel. The stopper assembly includes a sequential stopper body responsive to fluid forces for enabling the sequential delivery of disparate contents, such as disparate fluids, separately held in the syringe barrel. The sequential stopper body has a generally cylindrical sidewall with a distal end, a proximal end and a longitudinal axis therethrough. The stopper assembly also includes a generally cylindrical flow channelizer mounted to the distal end of the sequential stopper body. The flow channelizer enables the reconstitution of dry medicament held in the syringe barrel distally of the flow channelizer. The flow channelizer features opposed proximal and distal ends and a generally cylindrical outer surface therebetween. At least one fluid flow channel extends between the proximal and distal ends of a flow channelizer.

Abstract: A connector assembly provided for efficient flow of liquid into and/or out of a vial, such as a vial containing a lyophilized drug. The connector assembly features a collar mountable to the rim of the vial in a locked position and thereafter removable by an end-user when disposal of the device is desired. A protective cap mountable over the collar includes an annulus-type ring at its proximal end which mounts over locking structure associated with the collar. The ring is secured to the protective cap via one or more user-severable connections. As the cap is urged proximally, the ring places the collar in the locked position with the vial rim, exerting an inwardly-directed force onto the locking structure to secure the collar to the vial rim. The cap can be separated from the ring at its user-severable connections, and the device used in its ordinary matter. When disposal is desired, the ring may be urged proximally out of engagement with the locking structure of the collar.

Abstract: A connector assembly is provided for efficient flow of liquid into and/or out of a vial, such as a vial containing a lyophilized drug. The connector assembly includes a spike slidably mounted in the open top of the vial. The connector assembly further includes a stopper sealingly engaged in the open top of the vial and slidably moveable in response to the axially movement of the spike. Thus, movement of the spike relative to the vial will move the stopper into or out of sealing engagement with the vial. The connector assembly further includes a spring for generating a small amount of axial movement of the spike after the stopper has been moved into the opened position in the vial. Movement of the spike generated by the spring will cause a sufficient change in pressure to overcome surface tension and initiate an efficient flow of fluid into or out of the vial.

Abstract: A stopper assembly having by-pass features for use in a multi-chamber syringe barrel. The stopper assembly includes a sequential stopper body responsive to fluid forces for enabling the sequential delivery of disparate contents, such as disparate fluids, separately held in the syringe barrel. The sequential stopper body has a generally cylindrical sidewall with a distal end, a proximal end and a longitudinal axis therethrough. The stopper assembly also includes a generally cylindrical flow channelizer mounted to the distal end of the sequential stopper body. The flow channelizer enables the reconstitution of dry medicament held in the syringe barrel distally of the flow channelizer. The flow channelizer features opposed proximal and distal ends and a generally cylindrical outer surface therebetween. At least one fluid flow channel extends between the proximal and distal ends of a flow channelizer.

Abstract: A connector assembly is provided for efficient flow of liquid into and/or out of a vial, such as a vial containing a lyophilized drug. The connector assembly includes a spike and a stopper sleeve, both slidably mounted in the open top of the vial. The connector assembly includes a stopper affixed to the stopper sleeve and sealingly engaged in the open top of the vial. The stopper is slidably moveable in response to axial movement of the stopper sleeve. Movement of the stopper sleeve relative to the vial will move the stopper into or out of sealing engagement with the vial. The connector assembly further includes a spring for generating a small amount of axial movement of the spike, stopper sleeve and stopper after the stopper has been moved into the opened position in the vial. Movement of the spike, stopper sleeve and stopper generated by the spring will cause a sufficient change in pressure to overcome surface tension and initiate an efficient flow of fluid into or out of the vial.

Abstract: A sequential stopper having structural features for facilitating substantially complete delivery of fluid held within a syringe barrel. The sequential stopper features a stopper body having a cylindrical side wall, proximal and distal ends, and one or more circumferentially-disposed sealing elements thereabout. One of the circumferentially-disposed sealing elements may be located adjacent the proximal end of the stopper body. An elongate hollow chamber is disposed within the stopper body parallel to the longitudinal axis of the stopper body. A pair of longitudinal sealing elements are disposed on the cylindrical side wall of the stopper body and are separated on the sidewall by a distance greater than a maximum width displayed by the elongate hollow chamber disposed within the stopper body. A recessed surface is disposed between the longitudinal sealing elements adjacent the proximal end of the stopper body.

Abstract: A lockable safety shield for a prefillable syringe is provided. The design of the lockable safety shield enhances pharmaceutical manufacturers' ease of assembling the various components as part of its filling or processing of the prefillable syringes in normal practice. A collar is attachable to the distal hub of the prefillable syringe. A safety shield is axially slidable over the collar between a retracted position, wherein the distal end of the piercing element associated with the prefillable syringe is exposed, and an extended position, wherein the safety shield is locked to the collar to protectively cover the distal end of the piercing element. The safety shield includes locking structure configured so that the shield, as supplied to the pharmaceutical manufacturer, can be easily fitted to the syringe. The locking structure includes at least one deflectable arm provided on the body of the shield. The deflectable arm includes a proximal end deflectable towards the interior of the shield.