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.

Description

FIELD OF THE INVENTION [0001] This Invention relates to cryopreservation of blood or blood components at cryogenic temperatures. BACKGROUND OF THE INVENTION [0002] It has been known in blood bank industry that long-term storage of blood components can be achieved at cryogenic temperature. Plasma can be stored for one year at −18° C. to be thawed and used for therapeutic applications. Concentrated red blood cells (RBC) treated with glycerol can be stored for 10 years at −70° C. to be used again. Recently, a new technique has been established to cryopreserve hematopoietic stem and progenitor cells of neonatal or fetal blood. These cells that have been cryopreserved and thawed can be used for autologous reconstitution. Hematopoietic stem cells treated with cryoprotectant fluids are expected to survive a long-term storage in liquid Nitrogen at −196° C. [0003] Throughout all these cryogenic preservation applications, plasma, RBC, or progenitor stem cells are stored in plastic bags of dif...

AI Technical Summary

Benefits of technology

[0005] The present invention provides a container, which may be used for collecting and safely storing biological fluids, blood cells, and hematopoietic stem and progenitor cells at temperature ranging from normal body temperature to cryogenic liquid Nitrogen temperature. The container is fabricated of metal that characterized with high strength and high toughness to endure very low cryogenic temperature and to suppress any effect of the embrittlement. The container has the shape of a rectangular parallelepiped with a large flat base and a modest height. All edges are contoured with radius to eliminate high stress concentration spots on the container structure. The significant aspect ratio between the large flat base area and the thin profile of the container enhances the uniformity of phase changing process inside the container. The fine and uniform thickness of the sheet metal coupled with substantial thermal conductivity greatly improves the consistency of the freezing process. The container has sealable ports for channeling blood cells or biological fluids.

[0012] In another embodiment, the container internal surface is coated by a polymer such as silicone or laminated by a polymeric liner to add another protective layer to the container and to broaden the metal alloy selection.

[0013] It is common in blood bank industry to separate different blood products derived from one collected unit of blood. These products are stored in different containers and each container is labeled per FDA regulations and American Society of Blood Banks (AABB) standards. When blood products derived from one donor, are preserved for long-term storage, it is recommended to use more than one storage chamber. This is done in anticipation that a portion of the product can be used in the future and still keeping another portion in safe storage for potential use. It is also recommended that these stored portions are maintained in physically connected but safely separable containers. This invention provides a way of having metallic containers connected by breakable joints. These connected containers used to store blood products can be safely separated without compromising the sterility of the stored products, by simply breaking the joints in between. The invention also provides a holder that securely clinches on two or more containers to maintain them physically united. These containers can be safely separated by breaking the holder at specified breakable spots without compromising the sterility of the stored products.

[0014] It is preferred in certain applications to have a passageway permitting to channel fluids between the joint containers. These passageways could be made of metal or plastic material, and can be sealed or welded. The containers can be safely separated by first sealing each passageway at two spots and then cut the passageway in between the two sealed spots. The containers are safely separated without compromising the sterility and the medical integrity of the stored product.

[0018] In another embodiment, the metallic container having at least one face retaining a flexible corrugated geometry. This geometry is flexible enough to adjust the container shape for limited volume expansion caused by frozen fluids inside the container. Typically metallic containers are strong enough and tough enough to withstand any level of stress caused by frozen fluid volume expansion. The flexible geometry feature is used to relief stresses caused by expanding frozen fluid.

Problems solved by technology

Titanium can also be used to fabricate the container, but the cost could be higher.

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