Abstract: A connector device is disclosed for establishing fluid communication between a diluent container having sidewalls and a drug vial. The connector has a piercing member having a first end and a second end and a central fluid pathway. The piercing member is mounted to the liquid container and has fluid accessing portions hermetically sealed from an outside environment. A vial receiving chamber is associated with the piercing member and is dimensioned to connect to the vial. The vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the fluid accessing portions of the piercing member. Means are provided for connecting the vial receiving chamber to the liquid container.

Abstract: The present invention provides a septum for sealing an end of a medical connector. The connector has an end to attach to a closure of a container, the closure of the container having a target site, the connector further having a piercing member therein for piercing the target site of the closure. The septum comprises a disk having opposing first and second surfaces, a sheath extending axially from the first surface of the disk, and an annular ridge extending from the second surface of the disk, the annular ridge having a flared distal end, the distal end being dimensioned to form a fluid tight seal with the target area of the closure.

Abstract: The present invention provides a connector device for establishing fluid communication between a first container and a second container. The device has a first sleeve member having a first end and a second end and a sidewall defining a chamber, the first sleeve member having at the first end a first attaching member adapted to attach to the first container. The device further has a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and is movable axially with respect thereto from an inactivated position to an activated position. A second attaching member is positioned on the second end of the second sleeve and adapted to attach the second sleeve member to the second container. A piercing member positioned in the chamber and projecting from one of the first and second sleeve members is provided for establishing a fluid flow path from the first container to the second container. The piercing member is hermetically sealed.

Abstract: The present invention provides an apparatus for introducing a reconstituted drug in a drug vial into a medical liquid while venting any gas within the vial to the atmosphere. The assembly includes a receptacle disposed in the middle of a fluid conduit for the medical fluid and which has an upper chamber and lower chamber. The assembly also has a cannula assembly which mounts upon and pierces a septum of the receptacle and also a pierceable stopper of the drug vial. The cannula assembly includes a pair of coaxial cannulas which pierce the stopper of the drug vial and establish a first flow path from the upper chamber to the drug vial and a second flow path from the drug vial to the lower chamber. The cannula assemble also includes a cannula that forms a vent passage in fluid communication with an upper portion of the vial, upon the piercing of the drug vial, with an end of the vent passage communicating with the atmosphere.

Abstract: An improved drug delivery system and method for reconstituting drugs are provided. The system allows the delivery of a medicament from a drug vial (40) directly into an intravenous line to a patient. The system provides a method and an apparatus that insures that the drug vial (40) is properly pierced and the vial (40) is locked into an activated position when it is desired to use the same. To this end, a vial retaining member (50) for coupling the vial (40) to a cartridge (12) including a cannula (22) is provided. The retaining member (50) includes a cannula centering member extending from an end thereof.

Abstract: An adapter for interconnecting in fluid communication a first connection site and a beneficial agent container having a closure. The adapter includes a plate having first and second connection site sides. A wall extends from the plate from the second connection site side and constructed to surround only the closure. This allows containers having varying sized bodies to be received. A cannula structure is rigidly secured in the plate and defines a flow path extending through the plate. The adapter can be provided in an assembly with the beneficial agent contained or in a drug delivery system.

Abstract: A drug delivery device is provided comprising a cartridge body including an upper portion defining a vial receiving area and terminating in a wall, the cartridge body including a cannula extending from the wall. A vial including a beneficial agent is coupled by a retaining member to the cartridge body in an inactivated position. The retaining member allows the vial to move to an activated position. The retaining member including an outer member and an inner member, the inner member separating from portions of the outer member as the vial moves from the inactivated position to the activated position.

Abstract: The present invention provides an improved cannula that can be used to reconstitute powdered drugs in a drug delivery system. Furthermore, the present invention provides a cannula and drug delivery system incorporating same. To this end, the present invention provides a cannula structure for use in a reconstitution device for reconstituting a powdered drug comprising a cannula having a first end and a second end, and defining a channel in an interior thereof between the first and second ends. The first end is closed and includes a member for piercing a septum. The cannula includes at least two slots providing fluid communication between the channel and an exterior of the cannula. The slots are located in juxtaposition to the first end and have a width, as measured along a length of the cannula, that is less than a length, as measured around the cannula. The slots also have a minimum projected area equal to or greater than the cross-sectional area of the channel.

Abstract: The present invention provides a sheath for at least removably covering the blunt end of the cannula. The sheath allows the cannula to be presterilized and utilized without subsequent sterilization. The sheath comprises a body member defining an interior for receiving at least a portion of the blunt cannula, the body member including a first end and a second end, the second end having an opening for receiving at least a portion of the cannula. The first end including a wall member so constructed and arranged as to rip upon the exertion of a sufficient perpendicular force by an end of the blunt cannula. The body also includes side walls extending between the first and second end, the side walls are so constructed and arranged so as to slide back along the cannula toward the second end upon the tearing of the first end by the cannula and the application of a sufficient force upon the side walls.

Abstract: An apparatus (60) and system (20) are disclosed for the patient-controlled delivery of an analgesic or other beneficial agent 142, while preventing administration of a toxic quantity of the beneficial agent. The invention permits delivery of fractional doses to a patient in quantities which are directly proportional to the time period since the last dose or fraction thereof was delivered to the patient. In the preferred embodiments the apparatus includes a housing (58) including a casing (88) and a back plate (86), the housing containing a control switch (84) for opening and closing downstream conduit (62) and for depressing a floating plate (100) that thereby compresses a dose reservoir (90) with the beneficial agent (142) therein. A spring (124) biases the control switch (84).

Abstract: A port and closure assembly is provided. The closure includes a sleeve member and the port a rib member. The sleeve member having an inner circumference that is less than the outer circumference of the rib. The port and closure cooperating to produce an audible signal when the closure is removed from the port.

Abstract: A port and closure assembly is provided. The closure includes a cap that cooperates with the port to produce a friction fit. The cap and port are hermetically sealed together by a coating. The coating provides a method of determining if the closure has been opened.

Abstract: A improved port and closure assembly is provided. The closure is overmolded to the port. The closure hermetically seals the port and provides a tamper evident closure. The closure cooperates with the port to provide a band that circumscribes the port after the closure is removed.

Abstract: A method is disclosed for forming, filling and hermetically sealing a blowmolded container having a sterile integral inner dispensing outlet, all in a single sterile operation. The method is directed toward establishing a preferably hermetic seal between the inner dispensing outlet and the container neck, by establishing the seal early in the blowmolding cycle. This is accomplished by mounting the dispensing outlet-defining tubular member about a unique fluid supply mandrel. The supply mandrel thereby also serves as a check and the tubular member of the to-be-formed container serves as a tool in blowmolding. The dispensing outlet/container neck seal is thus formed before the blowmolding step.

Abstract: A one-piece integral plastic container is disclosed which has an outer closure or overcap removable along a frangible line of weakness, and a separately-formed inner closure that is maintained in sterile condition by the outer closure until the container contents are dispensed. The inner closure comprises a tubular member inserted in fluid-tight relationship within the container neck after the container body and neck are molded, but prior to formation of the outer closure. The tubular member thus provides the dispensing outlet for the container and is maintained in sterile condition by the overcap which encloses it.

Abstract: Containers used for storing and dispensing liquids for medical applications and formed in a one-piece, molded construction include a neck defining a dispensing outlet and an annular lip, a closure for the outlet and a frangible section coupling the closure to the neck. An article of manufacture and a method are provided where a frangible section couples the closure to the neck and defines an annular channel between the outlet lip and the closure. Completing the article of manufacture and method, the neck has an overmold which engages the closure whereby the molding of the overmold may tend to reduce the bio-burden at the area of contact of the overmold and the neck and whereby displacement of the overmold ruptures the frangible section permitting removal of the overmold and closure for opening of the container.

Abstract: A plastic container and a three-piece closure system therefor are disclosed. The container has a threaded neck defining a dispensing outlet. A separate closure covers the dispensing outlet and is heat-sealed to the threaded neck, forming a frangible section which may be broken to remove the closure. An internally threaded jacking ring is threadedly received on the neck, and includes a plurality of inwardly directed flexible fingers, which snap into an annular groove in the closure when the jacking ring is threaded onto the neck. To break the frangible portion and open the container, the jacking ring is rotated in the direction to remove it, so that the jacking ring fingers press against the top edge of the recess in the closure and actually pry the closure away from the container neck.

Abstract: An opening ring (40) for a bottle (29) has a closure element (36) attached to the bottle neck (30) at a frangible section (38). The opening ring (40) includes rigid shock absorbing means such as a collar (58) to protect the bottle from unwanted opening of the frangible section (38) which would thereby destroy the seal, and in the case of bottle-stored sterile liquids, contaminate same.

Abstract: A one-piece integral plastic container is disclosed which has an outer closure or overcap removable along a frangible line of weakness, and a separately-formed inner closure that is maintained in sterile condition by the outer closure until the container contents are dispensed. The inner closure comprises a tubular member inserted in fluid-tight relationship within the container neck after the container body and neck are molded, but prior to formation of the outer closure. The tubular member thus provides the dispensing outlet for the container and is maintained in sterile condition by the overcap which encloses it.

Abstract: A closure system for a container having a neck with a cap support flange extending radially outwardly around the neck. A resilient gasket encircles the neck and overlies the cap support flange, to be compressed by a closure cap which is attached to the neck for sealing. Annular rib means project from the support flange against the gasket to retain the gasket in its sealing position. A method is also described for the manufacturing of such a closure system.