Container for preserving blood products at cryogenic temperatures

Abstract

Metallic containers with high toughness characteristics are utilized to cryopreserve blood products and more particularly neonatal stem and progenitor cells at cryogenic temperatures. Metallic containers with high toughness and strength characteristics are durable at low temperatures and are capable to endure high stresses and impacts at −196° C. These containers are better fit to preserve blood products without compromising their sterility or their medical integrity. Methods for fabricating metallic containers are also disclosed.

1 - Thin wall metallic container to receive biological fluids, comprising; 
 enclosure encompassing a volume confined by a first surface situated in a plane, a second surface situated in a plane that is parallel to and at a distance from the first surface, and a sidewall circumscribing the first and the second surfaces, whereas one edge of the sidewall is entirely connected to the periphery of the first surface and blends therewith, and the second edge of the sidewall is entirely connected to the periphery of the second surface and blends therewith, wherein said enclosure having contoured edges and blended corners, and    plurality of portals disposed at the top end of said enclosure, having means to communicate the interior of said enclosure to the exterior,    wherein the container is used to cryopreserve blood products at cryogenic temperatures, said blood product including whole blood or any of its component(s), erythrocytes, leukocytes, platelets, stem cell, and plasma either alone or in combination.    
   
   
       2 - The container according to  claim 1 , wherein the metallic container is made of stainless steel alloys.  
   
   
       3 - The container according to  claim 1 , wherein the metallic container is made of Titanium alloys.  
   
   
       4 - The container according to  claim 1 , wherein the metallic container is formed by seal welding two previously fabricated and preferably symmetrical half shells, said half shell having uniform thickness and encompassing a planar base circumscribed by a sidewall blended by a contoured radius to the planar base, furthermore said half shells comprise semicircular cylindrical shells extending longitudinally outward from the top edge of the sidewall in a plane parallel to the planar base, said semicircular cylindrical shells form tubular portals when welded to the matching semicircular cylindrical shells.  
   
   
       5 - The container according to  claim 1 , wherein the metallic container is fabricated by seal welding a half shell to an overlay sheet metal, said half shell having uniform thickness and encompassing a planar base circumscribed by a sidewall blended by a contoured radius to the planar base; whereas tubular portals are welded to at least one surface of said container.  
   
   
       6 - The container according to  claim 1 , wherein plastic bushings are seal bonded or welded to the metallic tubular ports.  
   
   
       7 - The container according to  claim 1 , wherein at least one face of the container having a curved surface arrangement, said arrangement includes concave and convex surfaces, grooves, and bumps.  
   
   
       8 - The container according to  claim 1 , wherein at least one face of the container having the shape of a funnel converging to a fluid channeling portal.  
   
   
       9 - The container according to  claim 1 , wherein at least one face of the container retaining a flexible geometric feature having means to relief stresses generated by limited volume expansion.  
   
   
       10 - The container according to  claim 1 , wherein the metallic surface is coated with a biocompatible polymer.  
   
   
       11 - The container according to  claim 1 , wherein a biocompatible plastic laminate covering the inner surface of said container, wherein the plastic material is selected from a group consisting essentially of silicone, polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl-acetate, fluropolymers, or copolymers of these materials.  
   
   
       12 - The container according to  claim 1 , wherein a plurality of said container are jointly interconnected by breakable metallic bonds with defined breaking lines that permit each container to separate safely and aseptically when the bond is broken.  
   
   
       13 - The container according to  claim 1 , wherein a plurality of said container are secured to a breakable holder with defined breaking lines that permit each container to separate safely and aseptically when the holder is broken.  
   
   
       14 - Thin wall metallic container to receive biological fluids, comprising; 
 enclosure having at least two compartments separated by a partition, each compartment encompassing a volume confined by a first surface situated in a plane, a second surface situated in a plane that is parallel to and at a distance from the first surface, and a sidewall circumscribing the first and the second surfaces, whereas one edge of the sidewall is entirely connected to the periphery of the first surface and blends therewith, and the second edge of the sidewall is entirely connected to the periphery of the second surface and blends therewith, wherein said compartments having contoured edges and blended corners,    plurality of portals disposed at the top end of said enclosure with at least one portal per compartment, wherein said portals having means to communicate the interior of said compartment to the exterior, and    a passageway providing fluid communication between said compartments, wherein said passageway having means to be permanently sealed preventing any fluid communication there through,    wherein the container is used to cryopreserve blood products at cryogenic temperatures, said blood product including whole blood or any of its component(s), erythrocytes, leukocytes, platelets, stem cell, and plasma either alone or in combination.    
   
   
       15 - The container according to  claim 14 , wherein the metallic container is made of stainless steel alloys.  
   
   
       16 - The container according to  claim 14 , wherein the metallic container is made of Titanium alloys.  
   
   
       17 - The container according to  claim 14 , wherein the metallic container is formed by seal welding two previously fabricated and preferably symmetrical half shells, said half shell having at least two depressions, each having uniform thickness and encompassing a planar base circumscribed by a sidewall blended by a contoured radius to the planar base, wherein the matching depressions of the welded half shells constitute said compartments, furthermore said half shells comprise semicircular cylindrical shells extending longitudinally outward from the top edge of the sidewall in a plane parallel to the planar base, said semicircular cylindrical shells form tubular portals when welded to the matching semicircular cylindrical shells.  
   
   
       18 - The container according to  claim 14 , wherein the metallic container is fabricated by seal welding a half shell having at least two depressions, each having uniform thickness and encompassing a planar base circumscribed by a sidewall blended by a contoured radius to the planar base, to an overlay sheet metal, wherein the depressions and the welded overlay constitute said compartment, whereas tubular portals are welded to at least one surface of said compartment.  
   
   
       19 - The container according to  claim 14 , wherein the passageway connecting said compartments is completely sealable, whereas compartments joined by passageway are aseptically separable after sealing connecting passageway.  
   
   
       20 - The container according to  claim 14 , wherein the enclosure having two compartments constituting one major portion and one minor portion, each compartment further encompassing at least one portal for fluid communication and a label on the outer surface of said compartment for identification of the contents within.