Abstract: A resealable transfer assembly for a container such as a bottle or vial featuring a membrane for selectively opening or sealing a fluid path between the bottle and a medical delivery device introduced into the assembly. The assembly includes a body disposed on the bottle, and a luer connector hub which may be separately provided with the body or formed integrally therewith. A free plug rests in a cavity defined within the luer connector hub. The free plug includes an orifice dimensioned to accept a luer tip associated with the medical delivery device. A membrane, preferably formed from an elastomeric material, is secured across both the opposed end of the luer connector hub and the open top of the bottle, and may be retained between the top surface of the bottle and the body. The membrane preferably includes a central area sealing the opposed end of the luer connector hub from the open top of the bottle, with one or more fluid openings defined on a portion of the membrane outside of the central area.

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 lyophilization closure assembly for a container or vial is disclosed. The lyophilization closure assembly is self-supporting with the container and may be employed with the container during a lyophilization process, eliminating the need for a separate crimping operation outside of the sterile environment in which lyophilization is conducted. The lyophilization closure assembly includes a body with a skirt disposed around the rim of the container. The skirt features one or more deflectable abutments and one or more deflectable latches positionable about the rim of the container, and defines one or more vapor passages. An elastomeric closure is retained within the body for sealing the open top of the medicament container. The elastomeric closure features a plug for sealing the open top of the container and a top surface facing away from the open top of the container. The body defines an opening over the elastomeric closure that delimits an access area on the top surface of the closure.

Abstract: A sterile closure assembly for a container or vial includes an elastomeric closure for sealing the open top of a medicament container. The elastomeric closure features a plug for sealing the open top of the container and a top surface facing away from the open top of the container. A washer is secured in surface contact with the top surface of the closure. The washer defines an opening that delimits an access area on the top surface of the closure for access by a fluid delivery device such as a syringe. A membrane is removably secured over the washer and hermetically encloses the access area of the elastomeric closure. The sterile closure assembly can be provided pre-assembled in a sterile state to assure the sterility of the top surface of the closure, obviating the need to sterilize the top surface of the closure, such as with an alcohol solution, prior to use of the vial.

Abstract: A syringe stopper for use in a syringe barrel having a substantially cylindrical body comprises a piston-like stopper body for slidable fluid-tight engagement inside the barrel of the syringe. The body includes a distal end, a proximal end and a longitudinal axis therethrough. A distally directed, conically-shaped projection is positioned on the distal end of the stopper body. At least one elongate discontinuity, running along the conically-shaped projection, is provided. The discontinuity includes a first end on the conically-shaped projection and extends radially outwardly therefrom to a second end, as viewed from the distal end of the stopper. The discontinuity may be in the form of a raised rib or a recessed groove.

Abstract: A syringe assembly includes a substantially cylindrical syringe barrel and a plunger stopper. Distal portions on the plunger stopper are configured to permit outflow of vapor from the syringe barrel during a lyophilization process. Proximal portions of the plunger stopper are dimensioned to engage the syringe barrel in sliding fluid-tight engagement. Liquid medication in the chamber is lyophilized and a vacuum is applied to the syringe barrel after lyophilization. The plunger stopper then is urged distally into sealing engagement with the syringe barrel. A plunger rod can be engaged with the plunger stopper. The tip cap is then removed and a diluent is drawn into the chamber by moving the plunger rod and the plunger stopper in a proximal direction. The syringe assembly then can be used in the standard manner.

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 resealable assembly for a container such as a bottle or vial featuring a membrane for selectively opening or sealing a fluid path between the bottle and a medical delivery device introduced into the assembly. The assembly includes a body disposed on said bottle, and a luer connector hub which may be separately provided with the body or formed integrally therewith. The luer connector hub features a connector end open for access by the medical delivery device, and an opposed end which is disposed for fluid communication with the open top of the bottle. A membrane, preferably formed from an elastomeric material, is secured across both the opposed end of the luer connector hub and the open top of the bottle, and may be retained between the top surface of the bottle and the body. The membrane preferably includes a central area sealing the opposed end of the luer connector hub from the open top of the bottle, with one or more fluid openings defined on a portion of the membrane outside of the central area.

Abstract: A backstop device to prevent inadvertent withdrawal of a stopper or plunger rod from the open distal end of a flangeless syringe barrel. The backstop includes a retaining wall configured to engage at least a portion of the syringe barrel, and a finger plate at the proximal end of the retaining wall. The finger plate includes an aperture adjacent the open proximal end of the syringe through which a stopper may be inserted. If desired, a ridge may be formed around the periphery of the aperture which may engage with a portion of the syringe barrel. The aperture and, if present, the ridge present a smaller passageway than the inside diameter of the syringe, preventing inadvertent removal of the stopper from the syringe. The backstop can be placed on the syringe regardless of the presence or absence of the plunger.

Abstract: A resealable vial connector assembly includes a transfer set having a body dimensioned for slidable insertion into a vial. The body includes an axial passageway for fluid communication into or out of the vial. A stopper support extends downwardly from the body and is dimensioned for receiving spaced apart upper and lower vial stoppers. The stopper support includes at least one passageway communicating with the axial space between the stoppers and with the passageway through the body. Upper portions of the transfer set are configured for threaded engagement with a luer collar of a medical fluid delivery instrument such as a hypodermic syringe or intravenous bag. The transfer set is configured for releasable locking engagement with the vial in a first position where both stoppers seal the entrance to the vial and in a second position where the lower stopper permits fluid communication between the vial and the passageway through the transfer set.

Abstract: A backstop device to prevent inadvertent withdrawal of a stopper from the open distal end of a syringe barrel. The backstop, mounted to a syringe flange, includes a pair of spaced apart plates located on either side of the flange. Both plates include respective apertures accessible through lead openings formed through the plates. The bottom aperture is formed for snug contact with the syringe barrel, while the upper aperture includes a ridge engageable with the interior of the syringe barrel adjacent the open distal end. The top aperture and ridge together present a smaller passageway than the diameter of the stopper, preventing inadvertent removal thereof. The backstop can be placed on the syringe regardless of the presence or absence of the plunger.

Abstract: A pre-fillable hypodermic syringe is provided. The hypodermic syringe includes a syringe barrel having opposed proximal and distal ends and a drug-receiving chamber therebetween. The distal end of the syringe receives a needle cannula that is sealingly and protectively covered by a cap. The proximal end of the syringe is sealed by a stopper assembly. The stopper assembly includes a distal stopper that is positioned adjacent the drug pre-filled into the syringe barrel. The distal stopper is formed to exhibit acceptably low sliding forces without the presence of lubricants deleterious to the drug. The stopper assembly further includes a proximal stopper formed from a material that exhibits acceptable microbiological sealing. Because the proximal stopper is separated from the drug by the distal stopper the proximal stopper may be treated with any convenient lubricant, such as silicone oil.

Abstract: A device for automatically injecting a material into the body is disclosed. The device includes a drive assembly and a syringe assembly which is mounted to the drive assembly. The drive assembly includes a drive rod, a driver releasably coupled to the drive rod, and a constant force spring which urges the drive rod towards the syringe assembly. The spring first urges the coupled drive rod and driver along the axis of the device, causing the skin to be penetrated by the needle of the syringe assembly. The drive rod is then decoupled from the driver. The spring continues to urge the drive rod in the axial direction, whereby the drive rod engages a piston in the syringe assembly and causes the displacement of the material therein.