Blood storage container containing aqueous composition for the storage of red blood cells
Inventors
Assignees
Publication Number
US-12178779-B2
Publication Date
2024-12-31
Expiration Date
2033-08-22
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Abstract
A blood storage container along with an aqueous composition for the storage of packed red blood cells is described. In a preferred embodiment, the container is not made of DEHP plasticizer. In some embodiments, the container is made from a polymeric material and a non-DEHP plasticizer. In some embodiments, the aqueous composition is made of about 1 to about 3 mM adenine, about 20 to about 115 mM dextrose, about 15 to about 60 unmetabolizable membrane-protectant sugar, about 20 to about 30 mM sodium bicarbonate, and about 4 to about 20 mM disodium phosphate. In a most preferred embodiment, the DEHP-lacking container is made from a PVC polymeric material and a DINCH plasticizer and the aqueous composition is made of about 2 mM adenine, about 80 mM dextrose, 55 mM unmetabolizable membrane-protectant sugar, about 26 mM sodium bicarbonate, and about 12 mM disodium phosphate.
Core Innovation
The invention provides a combination product consisting of a blood storage container and an aqueous composition specifically formulated for storage and preservation of collected red blood cells (RBCs). The storage container is constructed from a polymeric material combined with a non-phthalate plasticizer, explicitly excluding the use of di-ethylhexyl phthalate (DEHP). The aqueous composition within the container comprises adenine, dextrose, at least one non-metabolizable membrane-protectant sugar, and a pH buffering system containing a combination of physiologically acceptable agents that provide bicarbonate anions, phosphate anions, and sodium cations. The composition is substantially free of exogenously derived chloride ions.
The problem addressed is the need for prolonged storage of red blood cells in containers that do not include DEHP as a plasticizer. While DEHP has beneficial effects on maintaining the viability and long-term storage of RBCs, it is known to be toxic to humans and presents regulatory and health concerns, especially for sensitive populations. Existing additive solutions used in non-DEHP containers typically do not meet regulatory requirements for hemolysis after long-term storage, leading to a critical need for effective storage systems without DEHP.
The core invention achieves preservation of RBCs for at least 42 days under standard blood bank procedures without requiring periodic mixing, using a non-DEHP storage container and a specified aqueous composition. The pH buffering system is formulated to maintain the RBC suspension pH at a level that establishes a reaction equilibrium favoring glycolysis over the synthesis of 2,3-diphosphoglycerate, promoting net ATP gain and reducing hemolysis, thereby complying with regulatory standards for RBC quality and function after extended storage times.
Claims Coverage
The patent includes one independent claim, which describes a method for storing red blood cells (RBCs) using specific storage containers and storage solutions designed to meet regulatory criteria for extended red blood cell storage.
Method for storing RBCs in DEHP-lacking blood storage container with specified aqueous composition
The method includes: 1. Concentrating red blood cells to obtain packed RBCs. 2. Mixing the packed RBCs with a specified amount of an aqueous composition to achieve a suspension containing about 35% to about 80% RBCs by volume. 3. Cooling the RBC suspension to about 1 to about 6°C. 4. Storing the cooled suspension in a DEHP-lacking blood storage container without periodic mixing, following standard blood bank procedures. The aqueous composition specifically includes: - Adenine - Dextrose - At least one non-metabolizable membrane-protectant sugar - A pH buffering system comprising physiologically acceptable buffering agents, including at least one agent delivering bicarbonate anions, at least one agent delivering phosphate anions, and at least one agent delivering sodium cations - The aqueous composition is substantially free of exogenously derived chloride ions The method guarantees that the red blood cell suspension stored without periodic mixing for a storage period of 42 days meets US regulatory standards, ensuring a hemolysis level below about 1.0% with 95% confidence and 95% reliability for at least 42 days of storage.
The inventive feature centers on a method for storing RBCs with an aqueous composition and DEHP-lacking storage container engineered to meet regulatory requirements for extended storage duration without the need for periodic mixing.
Stated Advantages
Enables storage of red blood cells for at least 42 days with hemolysis levels below about 1.0%, thereby meeting US regulatory requirements.
Eliminates the need to use DEHP as a plasticizer in blood storage containers, reducing risks associated with DEHP toxicity.
Maintains the integrity and physiological function of stored red blood cells during prolonged storage without requiring periodic mixing.
Provides an improved storage system that is compatible with standard blood bank procedures and does not require special handling or equipment.
Documented Applications
Use for the storage and preservation of packed red blood cells intended for transfusion in patients.
Application in blood banking for prolonged storage (at least 42 days) of RBC units collected from donors.
Use in standard blood bank workflows without modification to existing procedures.
Direct storage of leukoreduced or pathogen inactivated RBCs in approved blood storage systems.
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