Additive transfer unit having a slidable piercing member

Abstract

An additive container and transfer unit for transferring a solution from the additive container to a container which is under a vacuum, the transfer unit including a closure having a transfer pin or piercing member which is axially movable from a first position to a second position within a supporting member or guide. The additive container and transfer unit is particularly applicable to the transfer of a medicament within the container to a vacuumized parenteral fluid container. In this application, the additive container is inverted and the point of the transfer pin projecting from the closure is positioned on the I.V. fluid bottle stopper. As downward thrust is applied to the additive container, the end of the transfer pin projecting from the closure will pierce the I.V. fluid bottle stopper. As further thrust is applied, the additive container closure will move along the transfer pin, the other end of the transfer pin thereby piercing the diaphragm portion of the stopper within the transfer unit thereby providing a pathway between the two containers through the passageway in the transfer pin. The vacuum within the vacuumized container will then draw the solution within the additive container into the vacuumized container.

What is claimed is: 
     
       1. An additive transfer unit for storing and transferring of a medicament to a .Iadd.solution .Iaddend.container having an exposed closure .[.and a vacuum therein.].; said transfer unit comprising .[.a.]. .Iadd.an additive .Iaddend.container for storing the medicament to be transferred, said .Iadd.additive .Iaddend.container having a rigid neck portion defining a finish, the opening in said .Iadd.additive .Iaddend.container being sealed by a closure affixed thereto;   said closure having a shoulder for resting against said finish of the rigid container neck, said closure including a puncturable stopper with a pierceable diaphragm portion positioned in sealing engagement with the opening in the .Iadd.additive .Iaddend.container and in a substantially stationary manner;   a tubular member having a cylindrical portion, the cylindrical portion including a central opening therein for slidably receiving a piercing member;   said tubular member including an undercut in the outside surface of the cylindrical portion thereof, sealing means positioned in said undercut;   a hood engageable with the cylindrical portion of the tubular member and the sealing means to cover the piercing member and tubular member prior to use of the unit;   said tubular member being positioned and arranged so that the opening therein overlies the diaphragm portion of said stopper;   crimping means to affix the closure and tubular member to the .Iadd.additive .Iaddend.container;   said piercing member being positioned within said central opening in said member and having a passageway therethrough for the flow of said medicament and a point on both ends thereof;   said piercing member having an integral stop and being movable from the first position for entry through the closure of the .[.vacuumized.]. .Iadd.solution .Iaddend.container with said integral stop constructed and arranged to contact said exposed closure of .[.vacuumized.]. .Iadd.said solution .Iaddend.container to a second position for puncturing of the stopper in the additive container to thereby provide a pathway between the containers and permit the medicament within the additive container to transfer into the .[.vacuumized.]. .Iadd.solution .Iaddend.container.   
     
     
       2. The additive transfer unit of claim 1 wherein said tubular member includes an annular flange extending from one end thereof, the flange being positioned on the stopper so that the opening within the cylindrical portion overlies said stopper, and said crimping means for affixing said closure and tubular member to said .Iadd.additive .Iaddend.container includes a ferrule crimped about the flange and container to affix said member and stopper to the .Iadd.additive .Iaddend.container. 
     
     
       3. The additive transfer unit of claim 2 wherein the piercing member comprises a needle having a hub, the diameter of the hub being coextensive with the central opening through the tubular member to thereby prevent leakage of fluid while at the same time permitting the hub to slide within the central opening, the length of the needle being longer than the length of the hub so that the pointed ends thereof project from either end of the hub. 
     
     
       4. An additive transfer unit for storing and transferring of a medicament to a .Iadd.solution .Iaddend.container having an exposed closure .[.and a vacuum therein.].; said transfer unit comprising .[.a.]. .Iadd.an additive .Iaddend.container for storing the medicament to be transferred, said .Iadd.additive .Iaddend.container having a rigid neck portion defining a finish, the opening in said container being sealed by a closure affixed thereto;   said closure having a shoulder for resting against said finish of the rigid container neck, said closure including a puncturable stopper positioned in sealing engagement with the opening in the .Iadd.additive .Iaddend.container and in a substantially stationary manner, and means for affixing the stopper to the .Iadd.additive .Iaddend.container;   said stopper including a central opening extending along the longitudinal axis thereof for slidably receiving a piercing member, the end of the stopper projecting into the container being sealed by a puncturable diaphragm;   a piercing member having a passageway therethrough for the flow of said medicament and a point on both ends thereof and disposed within the central opening in said stopper, one end of the piercing member extending from said opening;   said piercing member having an integral stop and being movable from a first position for entry through the closure of the .[.vacuumized.]. .Iadd.solution .Iaddend.container with said integral stop contacting said exposed closure of the .[.vacuumized.]. .Iadd.solution .Iaddend.container to a second position for puncturing of the diaphragm of the stopper in the additive container to thereby provide a pathway between the containers and permit the said medicament within the additive container to transfer into the .[.vacuumized.]. .Iadd.solution .Iaddend.container;   said integral stop of the piercing member including an annular shoulder extending from the body thereof at a point in the portion of the piercing member which extends from the central opening in the stopper, said shoulder preventing excessive movement of the piercing member in the central opening in the stopper when the piercing member is inserted in the closure of .[.a vacuumized.]. .Iadd.said solution .Iaddend.container;   said piercing member including an elongated body with said point on either end thereof and a projection extending from the body intermediate the ends thereof;   the central opening within the stopper including an undercut to receive the projection on the piercing member when the piercing member is moved from the first position to the second position within the central opening in the stopper for puncturing of the diagram of the stopper whereby the projection on the piercing member will engage the undercut in the opening in the stopper to thereby retain the piercing member within the opening in the stopper when the transfer unit is withdrawn from the .[.vacuumized.]. .Iadd.solution .Iaddend.container.   
     
     
       5. The additive transfer unit of claim 4 including a hood for protecting the piercing member and stopper prior to use, said hood having a flange extending from the open end thereof, the flange of the hood overlying said stopper, and means for affixing the hood to the .Iadd.additive .Iaddend.container. 
     
     
       6. The additive transfer unit of claim 5 wherein the means for affixing the hood to the .Iadd.additive .Iaddend.container comprises a tamperproof, removable seal fastened to the .Iadd.additive .Iaddend.container and hood so that upon removal of the seal, the hood can be removed to expose the piercing member. .Iadd. 7. The additive transfer unit as defined in claim 4 wherein said solution container is vacuumized. .Iaddend.