Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma

Abstract

A freeze-dried material is stored in a first chamber of a container along with a reconstituting liquid for the freeze-dried material, which is stored in a second chamber of the container. A sealing wall within the container forms a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid. At least one valve assembly in the sealing wall selectively opens a region of the sealing wall to establish fluid flow communication between the first and second chambers, allowing the freeze dried material to be reconstituted. The reconstituted freeze-dried material can be administered from the same container to a recipient.

1 . Apparatus comprising:
 a dry freeze-dried material,   a reconstituting liquid for the freeze-dried material, and   a flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers.   
     
     
         2 . Apparatus according to  claim 1   wherein the valve assembly includes a pressure sensitive valve operative between a normally closed condition normally resisting fluid flow communication between the first and second chambers and an opened condition establishing fluid flow condition communication between the first and second chambers in response to a pressure differential applied across the valve.   
     
     
         3 . Apparatus according to  claim 2   wherein the pressure sensitive valve comprises a flap valve.   
     
     
         4 . Apparatus according to  claim 1   wherein the valve assembly includes a normally closed septum operative in a normally closed condition maintaining closure between the first and second chambers and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum.   
     
     
         5 . Apparatus according to  claim 4   wherein the septum includes a tear member coupled to a pulling member to at least partially tear the septum.   
     
     
         6 . Apparatus according to  claim 1   wherein the valve assembly includes a pressure sensitive valve operative between a normally closed condition normally resisting fluid flow communication between the first and second chambers and an opened condition establishing fluid flow condition communication between the first and second chambers in response to a pressure differential applied across the valve, and a normally closed septum associated with the valve operative in a normally closed condition maintaining closure between the first and second chambers independent of the valve and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum and a pressure differential applied across the valve.   
     
     
         7 . Apparatus according to  claim 6   wherein the pressure sensitive valve comprises a flap valve.   
     
     
         8 . Apparatus according to  claim 6   wherein the septum includes a tear member coupled to a pulling member to at least partially tear the septum.   
     
     
         9 . Apparatus according to  claim 1   further including an outer skirt overlaying an exterior wall of the container in a region of the sealing wall.   
     
     
         10 . Apparatus according to  claim 9   wherein the outer skirt includes a tear member coupled to a pulling member to tear the outer skirt for removal.   
     
     
         11 . Apparatus according to  claim 9   wherein at least a portion of the exterior wall of the container overlaid by the outer skirt includes placations.   
     
     
         12 . Apparatus according to  claim 9   wherein the flexible container includes an integral administration port for administering material from the container.   
     
     
         13 . Apparatus according to  claim 1   wherein the freeze-dried material includes freeze-dried human plasma.   
     
     
         14 . A method comprising
 providing a flexible container including first chamber holding a freeze-dried material in a dry state, a second chamber holds a reconstituting liquid for the freeze-dried material, the flexible container including an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,   manipulating the valve assembly to open the region, and   expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.   
     
     
         15 . A method according to  claim 14   further including reconstituting the freeze-dried material by successively expressing a mixture of the reconstituting liquid and freeze-drive material between the first and second chambers, thereby preparing a reconstituted product.   
     
     
         16 . A method according to  claim 15   further including administering the reconstituted product directly from one of the chambers to a recipient.   
     
     
         17 . A method according to  claim 14   wherein the freeze-dried material includes freeze-dried human plasma.   
     
     
         18 . A method comprising
 providing a flexible container including first chamber holding a freeze-dried material in a dry state, a second chamber holding a reconstituting liquid for the freeze-dried material, the flexible container including an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers, and an outer skirt overlaying an exterior wall of the container in a region of the sealing wall and blocking manipulation of the valve assembly,   removing the outer skirt to expose the valve assembly to manipulation,   manipulating the valve assembly to open the region, and   expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.   
     
     
         19 . A method according to  claim 18   further including reconstituting the freeze-dried material by successively expressing a mixture of the reconstituting liquid and freeze-drive material between the first and second chambers, thereby preparing a reconstituted product.   
     
     
         20 . A method according to  claim 19   further including administering the reconstituted product directly from one of the chambers to a recipient.   
     
     
         21 . A method according to  claim 18   wherein the freeze-dried material includes freeze-dried human plasma.   
     
     
         22 . A method comprising
 providing a flexible container including first chamber, a second chamber, and an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber, and at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,   preparing a freeze-dried material comprising freeze-dried human plasma,   placing the freeze dried material in the first chamber of the container, and   placing a reconstitution liquid for the freeze dried material in the second chamber of the container.   
     
     
         23 . A method according to  claim 22   further including manipulating the valve assembly to open the region, and   expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.   
     
     
         24 . A method according to  claim 23   further including reconstituting the freeze-dried material by successively expressing a mixture of the reconstituting liquid and freeze-drive material between the first and second chambers, thereby preparing a reconstituted product.   
     
     
         25 . A method according to  claim 24   further including administering the reconstituted product directly from one of the chambers to a recipient.