Seal cap with pre-filled agent for a specimen container

Abstract

A seal cap assembly for use with a biological specimen container, the cap assembly including an integral ampoule that holds a pre-filled agent. A piercer is movably disposed in the cap assembly to pierce into the ampoule. When the cap assembly is attached to a biological specimen container, the ampoule is pierced, the pre-filled agent in the ampoule is mixed with the specimen, and the seal cap assembly seals the biological specimen container. The seal cap assembly, together with a biological specimen container, permits stabilization, storage, and transport of biological fluid samples.

1 . A cap assembly for a specimen container, the cap assembly comprising:
 a housing defining an interior chamber having an open end;   a pre-filled agent disposed within the chamber;   a membrane covering and sealing the open end of the chamber to retain the pre-filled agent therein;   a piercer movably disposable within the housing; and   means for releasably attaching the cap assembly with a specimen container,   wherein engaging the cap assembly with a specimen container moves the piercer within the housing to penetrate the membrane, thereby permitting fluid communication between the pre-filled agent and a specimen in the specimen container.   
     
     
         2 . The cap assembly of  claim 1 , wherein the piercer and the housing include mating sealing features that seal the pre-filled agent and the specimen within the specimen container and cap assembly when the specimen container and cap assembly are engaged. 
     
     
         3 . The cap assembly of  claim 1 , wherein the pre-filled agent is any of a powder, liquid, gel, lyophilized cake, or lyophilized pellet. 
     
     
         4 . The cap assembly of  claim 1 , wherein the pre-filled agent is a chemical buffer to stabilize the specimen. 
     
     
         5 . The cap assembly of  claim 1 , wherein the membrane is any of a foil laminate, a co-extruded film, or an integral, molded portion of the piercer. 
     
     
         6 . The cap assembly of  claim 1 , wherein the membrane is sealed to the open end of the chamber using any of RF sealing, heat sealing, or adhesives. 
     
     
         7 . The cap assembly of  claim 1 , wherein the means for releasably attaching includes screw threads. 
     
     
         8 . The cap assembly of  claim 1 , wherein the means for releasably attaching utilizes any of a press fit, a friction fit, a snap fit, or a bayonet fitment. 
     
     
         9 . The cap assembly of  claim 1 , wherein the piercer is sized and shaped to create a flap in the membrane when the piercer penetrates the membrane. 
     
     
         10 . The cap assembly of  claim 1 , wherein the piercer is sized and shaped to move the pierced membrane substantially out of a fluid communication path between the pre-filled agent and a specimen in the specimen container. 
     
     
         11 . The cap assembly of  claim 2 , wherein the housing seals to the piercer, and the piercer seals to the chamber. 
     
     
         12 . The cap assembly of  11 , wherein at least one of the seals comprises an annular lip mating with an annular surface. 
     
     
         13 . The cap assembly of  claim 1 , wherein the specimen is saliva. 
     
     
         14 . A cap assembly for receiving a specimen container, the specimen container having a threaded end surrounding an opening, the cap assembly having a vertical axis and comprising:
 a first end including a housing defining a chamber, a pre-filled agent disposed in the chamber and retained by way of a retention member;   a second end opposite from the first and having threads sized to cooperate with the threads of the specimen container; and   an actuating member axially movable within the cap assembly intermediate the first end and the second end, the actuating member having an engagement surface for engaging the threaded end of the specimen container when the specimen container is threadably engaged with the second end of the cap assembly such that the actuating member penetrates the retention member thereby releasing the prefilled agent into the specimen container.   
     
     
         15 . The cap assembly of  claim 14 , wherein the retention member is a pierceable membrane and the actuating member includes a piercing tip. 
     
     
         16 . The cap assembly of  claim 14 , wherein the retention member is a frangible capsule and the actuating member includes a breaking member. 
     
     
         17 . The cap assembly of  claim 14 , wherein the piercing member is formed of a polymer. 
     
     
         18 . A kit, comprising:
 a plurality of specimen containers each defining an interior volume for containing a fluid specimen; and   a plurality of cap assemblies, each cap assembly configured to mate and form a seal with at least one of the specimen containers, each cap assembly comprising:
 a housing having walls forming an interior chamber; 
 a pre-filled agent disposed within the chamber; and 
 an actuating member slidably disposable within the housing, 
 wherein, when the cap assembly is mated with a specimen container, the actuating member causes the pre-filled agent to be released from the chamber and into the interior volume of the specimen container. 
   
     
     
         19 . The kit of  claim 18 , wherein each cap assembly further comprises a retention member that seals the pre-filled agent within the chamber, the actuating member operable to provide a fluid path through the retention member to release the pre-filled agent from the chamber. 
     
     
         20 . The kit of  claim 19 , wherein the retention member is a pierceable membrane and the actuating member includes a piercing tip that pierces the membrane to provide the fluid path.