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

Abstract

A vessel receives a liquid material, which is freeze-dried in situ within the vessel. A gas permeable material carried by the vessel provides gas transport for sublimation during drying. After freeze drying, an oxygen-free inert gas is introduced into the vessel through the gas permeable material, to occupy the interior of the vessel with the freeze-dried material. The gas permeable material is covered, to trap the oxygen-free inert gas within the vessel with the freeze-dried material. The freeze-dried material is stored in the entrapped oxygen-free inert gas within the vessel for a storage period. The vessel receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the vessel for administration to an individual.

Description

RELATED APPLICATIONS[0001]This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 11 / 881,493, filed 27 Jul. 2008, and entitled “Apparatus and Methods for Making, Storing, and Administering Freeze-Dried Materials Such as Freeze-Dried Plasma,” which is a continuation-in-part of co-pending U.S. patent application Ser. No. 11 / 725,352, filed 19 Mar. 2007, and entitled “Apparatus and Methods for Making, Storing, and Administering Freeze-Dried Materials Such as Freeze-Dried Plasma,” both of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to methods, systems, and apparatuses for manufacturing, storing and administering freeze-dried materials, such as single donor units of freeze-dried human plasma.BACKGROUND OF THE INVENTION[0003]First aid is critical for the survival of a person that has suffered a serious injury, such as a trauma victim. For instance, initial treatment of a severely wounded person in co...

AI Technical Summary

Benefits of technology

[0006]According to one aspect of the invention, a freeze-dried material, e.g., freeze-dried human plasma, is stored in a first chamber of a container along with a reconstituting liquid for the freeze-dried material, e.g., de-gassed water. The reconstituting liquid 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 can be manipulated to selectively open at least one region of the sealing wall to establish fluid flow communication between the first and second chambers. This allows the freeze dried material to be reconstituted within the container. The reconstituted freeze-dried material can also be administered directly from the same container to a recipient.

[0017]The system makes it possible for a material such a fresh human plasma to be freeze-dried, transported, stored, reconstituted, and administered in a single, multifunctional vessel.

[0020]In one embodiment, the method further includes, after freeze drying, introducing an oxygen-free inert gas into the interior space through the gas permeable material of the second end component. The oxygen-free inert gas occupies the interior space with the freeze-dried material to prevent deterioration of the material. The method also includes covering the gas permeable material of the second end component, to trap the oxygen-free inert gas within the interior space with the freeze-dried material. The method includes storing the freeze-dried material in the entrapped oxygen-free inert gas within the vessel for a storage period prior to introduction of the reconstituting liquid.

Problems solved by technology

For instance, initial treatment of a severely wounded person in combat situations can often mean the difference between life and death.

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