Patent ID: 7618408

Claim:
A vacuum break assembly configured to be mounted within a medicinal vial of the type containing multiple doses of medicinal composition ingestible into a patient by a syringe and hypodermic needle, in order to reduce the incidence and propagation of nosocomial infections resulting from airborne pathogen vectors or airborne contaminants introduced into medicinal fluids contained in the interior volume of said vial by pre-pressurization with ambient air injected by said syringe via its hypodermic needle in the process of inverting said vial for withdrawing a dose aliquot of fluid from the interior of said vial, comprising in operative combination: a) an elastomeric stopper configured to fit in a neck of said vial, said stopper having an exterior surface and an interior surface, and a central web portion defined between said surfaces; b) a needle sheath assembly secured in association with said stopper in a manner selected from at least a portion of said assembly compressively engaged with an inner surface of said stopper and embedded in said stopper, so that at least a portion of said central web portion is disposed between said needle sheath assembly and the exterior of said vial, said needle sheath assembly having a sleeve portion projecting into said vial interior beyond said stopper interior surface, said sleeve having an internal diameter greater than said hypodermic needle, a length greater than the length of said hypodermic needle, and said side wall of said sleeve portion having multiple perforations to permit said medicinal fluid to be accessed by said hypodermic needle when introduced into said vial through said stopper web into said needle sheath, said sleeve side wall including at least one perforation adjacent said stopper interior surface so that substantially all said medicinal fluid may be withdrawn from said vial in an inverted position; c) a bladder disposed in the interior volume of said vial and in association with said vial to compensate for change in volume of medicinal fluid in said vial as said medicinal fluid is withdrawn from said vial in an inverted position, said bladder isolating external air for volume compensation from said medicinal fluid so that said vial does not have to be pre-pressurized by a syringe prior to withdrawal of said medicinal fluid to prevent vacuum lock; d) said needle sheath assembly protecting said bladder from being pierced by said hypodermic needle when inserted in said vial through said stopper; and e) ambient air vent communicating with said vial interior to prevent vacuum lock and permit said bladder to compensate for medicinal fluid volume changes when said vial is in an inverted position without prepressurization of said vial with external air introduced by said hypodermic needle.