Three envelope package for sterile specimens

Abstract

A three-envelope package for preserving tissue specimens or other sterile objects. A sterile tissue sample is sealed within an innermost envelope sterile inside and out. The innermost envelope is sealed within the sterile interior of an intermediate envelope equipped with a peel-back seal for subsequent opening. Both the inside and the outside of the intermediate envelope are sterile. The intermediate envelope is sealed within the sterile interior of an outermost envelope, made of foil or another substance impermeable to a storage medium, such as liquid nitrogen. The outermost envelope provides complete impermeability to liquid nitrogen, eliminating the possibility of nitrogen seepage through the peel-back seal of the intermediate envelope. When the envelope package is removed from storage, the intermediate envelope is removed from the outermost envelope and can be opened in an assumed non-sterile environment, without contaminating the innermost envelope or the tissue specimen therein.

I claim: 
     
       1. A package for storage of a sterile transplantable specimen in a cryogenic atmosphere, comprising: an outermost envelope having a non-sterile exterior.Iadd., said envelope made from a material .Iaddend.that provides an impermeable barrier to . .the cryogenic atmosphere.!. .Iadd.liquid nitrogen .Iaddend.and .Iadd.said envelope .Iaddend.having closure means impenetrably sealed against . .the cryogenic atmosphere.!. .Iadd.liquid nitrogen .Iaddend.to define a closed sterile interior,   an intermediate envelope removably received within the outer envelope and having at least two walls sealed to each other around the periphery thereof to define the closed interior, and   an innermost envelope removably situated within the interior of the intermediate envelope comprised of at least two walls sealed to each other around the periphery thereof to define an inner, sterile cavity,   wherein said outermost envelope protects against contact by . .the cryogenic atmosphere.!. .Iadd.liquid nitrogen.Iaddend., and the intermediate envelope maintains the sterile exterior of the innermost envelope irrespective of possible contamination occurring to the exterior of the intermediate envelope during removal from the outer envelope, said package being in the cryopreserved state.Iadd., and wherein the outermost envelope and the innermost envelope are comprised of a material resistant to damage upon cryopreservation and thawing, and which is effective for protecting a transplantable tissue sample contained within the cavity of the innermost envelope from damage due to cryopreservation and thawing,   and further wherein the intermediate envelope comprises a peelback opening having a pair of surfaces defining the interior of the intermediate envelope and releasably bonded together along a predetermined course at the periphery of the interior; and the bond of the surfaces being selectively separable by peeling back one such surface relative to the other surface, thereby exposing the sterile interior of the intermediate envelope and the sterile innermost envelope received within, without subjecting the interior of the innermost envelope to possible contamination on the exterior of the intermediate envelope, so that the intermediate envelope is openable without subjecting the innermost envelope to possible contamination on the exterior of the intermediate envelope,   and further wherein the intermediate envelope comprises a peelback opening having a pair of surfaces defining the interior of the intermediate envelope and releasably bonded together along a predetermined course at the periphery of the interior; and the bond of the surfaces being selectively separable by peeling back one such surface relative to the other surface, thereby exposing the sterile interior of the intermediate envelope and the sterile innermost envelope received within, without subjecting the interior of the innermost envelope to possible contamination on the exterior of the intermediate envelope, so that the intermediate envelope is openable without subjecting the innermost envelope to possible contamination on the exterior of the intermediate envelope.Iaddend.. . .2. The package of claim 1 wherein the outermost envelope is comprised of a material resistant to damage upon cryopreservation and thawing, and which is effective for protecting a transplantable tissue sample contained within the cavity of the innermost   
     
     
        envelope from damage due to cryopreservation and thawing..!.3. The package 
     
     
        of claim 2 wherein the outermost envelope is comprised of polyimide. 4. The package of claim 3 wherein said polyimide is polyimide/fluorinated ethylene polypropylene laminate. . .5. The package of claim 1 wherein the innermost envelope is comprised of a material resistant to damage upon cryopreservation and thawing and which is effective for protecting a transplantable tissue contained within the innermost cavity from damage 
     
     
        due to cryopreservation and thawing..!.6. The package of claim 5 wherein 
     
     
        the innermost envelope is comprised of polyimide. 7. The package of claim 6 wherein said polyimide is polyimide/fluorinated ethylene polypropylene 
     
     
        laminate. 8. The package of claim 1 in combination with a transplantable tissue contained within the innermost envelope.