Anaerobic blood storage containers
Inventors
Yoshida, Tatsuro • Cordero, Rafael • SARITA, Jancarlo • ZOCCHI, Michael • Wolf, Michael • KEEGAN, Philip Michael • Renganathan, Narendran • Sutton, Jeffrey Karl
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Assignees
Member
HemanextHemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Publication Number
US-10849824-B2
Publication Date
2020-12-01
Expiration Date
Abstract
A blood storage container for the anaerobic storage of blood, having enhanced sealing methods and materials for the preservation of stored blood is provided.
Core Innovation
The invention is a blood storage device for storing oxygen-depleted blood that comprises an outer receptacle substantially impermeable to oxygen, a collapsible blood container, at least one inlet/outlet that is substantially impermeable to oxygen and in fluid communication with the collapsible container, and an oxygen sorbent situated within the outer receptacle. The inlet/outlet is a unitary, barrier traversing tube comprising an outer layer, an inner layer, and an oxygen barrier layer together with an oxygen-impermeable bond.
The patent addresses oxygen ingress through packaging, connections, and ports that leads to reoxygenation and storage lesions by providing materials, constructions, manifolds and bonds that minimize oxygen permeation and tubing-related ingress. The specification identifies tubing as the major source of oxygen ingress and specifies barrier traversing multilayer tubing constructions, unitary tubing/bonding approaches, and package integrity features to limit oxygen transmission to the contained, oxygen depleted blood.
The device includes an internal oxygen sorbent to maintain reduced oxygen conditions inside the outer receptacle and an optional spacer situated within the outer receptacle to provide separation and maintain low oxygen saturation during extended storage. The disclosure details oxygen-permeable membrane options for the collapsible blood container, sorbent chemistries and sachet formats, spacers, and permeability metrics for tubing and seals to achieve oxygen impermeability within the outer receptacle.
Claims Coverage
Two independent claims recite six main inventive features directed to blood storage devices for oxygen-depleted blood.
Outer receptacle substantially impermeable to oxygen
An outer receptacle that is substantially impermeable to oxygen forming an enclosure for the device and enclosing the collapsible blood container and internal components.
Collapsible blood container
A collapsible blood container situated within the oxygen-impermeable outer receptacle for containing the oxygen-depleted blood.
At least one inlet/outlet substantially impermeable to oxygen in fluid communication
At least one inlet/outlet that is substantially impermeable to oxygen passing through the outer receptacle and in fluid communication with the collapsible container.
Unitary barrier traversing inlet/outlet tube
A unitary tube comprising tubing and an oxygen-impermeable bond, where the unitary tube is a barrier traversing tube comprising an inner layer, an oxygen barrier layer, and an outer layer; in one construction comprising tubing 304, bond 302, and tubing 205.
Oxygen sorbent within outer receptacle
An oxygen sorbent situated within the outer receptacle to reduce oxygen within the outer receptacle surrounding the collapsible blood container.
Spacer within outer receptacle
A spacer located within the outer receptacle to provide separation between components.
The independent claims define an assembly combining an oxygen-impermeable outer receptacle enclosing a collapsible blood container, a substantially oxygen-impermeable inlet/outlet configured as a unitary, multilayer barrier traversing tube with an oxygen-impermeable bond, an oxygen sorbent within the receptacle, and an internal spacer.
Stated Advantages
Minimize oxygen ingress through packaging and inlet/outlet constructions to enable extended anaerobic storage.
Maintain less than 20% O2 saturation for extended storage, up to at least 64 days.
Maintains low headspace oxygen partial pressure and preserves or reduces blood oxygen saturation (SO2) during storage.
Extends shelf-life of stored oxygen-depleted whole blood or packed red blood cells and reduces storage lesions.
Provide defined barrier and moisture-vapor transmission performance targets to control permeability.
Documented Applications
Storing oxygen-depleted whole blood or packed red blood cells (pRBC) to extend shelf-life and reduce storage lesions.
Methods for deoxygenation and indicators for oxygen ingress detection.
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