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-12201584-B2
Publication Date
2025-01-21
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 provides an anaerobic blood storage device enclosing an inner collapsible blood container within an outer receptacle substantially impermeable to oxygen. An oxygen sorbent is situated inside the outer receptacle, and at least one inlet/outlet substantially impermeable to oxygen is in fluid communication with the inner collapsible container. The inlet/outlet is a unitary barrier-traversing tube comprising outer, inner, and intermediate oxygen barrier layers, with tubing 304, a bond 302, and tubing 205.
The inner collapsible blood container comprises polyvinyl chloride doped with a plasticizer. The invention addresses oxygen ingress into stored blood that compromises deoxygenation and reduces shelf life, particularly through tubing, bond gaps, and permeable packaging. It specifies oxygen-impermeable bonds, barrier-traversing tubing, and sealing and assembly techniques to reduce permeation and enable anaerobic storage.
The specification further details alternatives for inner container materials and plasticizers, membrane and spacer constructions, tubing permeability metrics, sorbent chemistries and formats, and methods for oxygen-impermeable bonds and seals. It provides spacer 213 and headspace management features, an oxygen indicator 215 [procedural detail omitted for safety], and quantitative performance targets [procedural detail omitted for safety] to support extended storage durations and maintenance of low headspace PO2.
Experimental data quantify oxygen permeation, identify PVC tubing as the dominant source of ingress, report oxygen ingress rates and sorbent performance, and demonstrate anaerobic storage with headspace PO2 stability exemplified by maintaining below 0.8 mmHg for 84 days. Manufacturing methods are described [procedural detail omitted for safety].
Claims Coverage
Overview: one independent claim (claim 1) defines a blood storage device and sets out five main inventive features that together define the oxygen-impermeable storage system.
Outer receptacle substantially impermeable to oxygen
An outer receptacle that is substantially impermeable to oxygen and surrounds the inner collapsible blood container.
Inner collapsible blood container comprising PVC doped with a plasticizer
An inner collapsible blood container comprising polyvinyl chloride (PVC) doped with a plasticizer.
At least one inlet/outlet substantially impermeable to oxygen in fluid communication with inner container
At least one inlet/outlet that is substantially impermeable to oxygen passing through the outer receptacle and that is in fluid communication with the inner collapsible container.
Oxygen sorbent situated within the outer receptacle
An oxygen sorbent located within the outer receptacle to scavenge residual oxygen inside the outer receptacle.
Unitary barrier-traversing tube comprising inner, barrier, and outer layers
The at least one inlet/outlet comprises a unitary tube that is substantially impermeable to oxygen comprising tubing 304, a bond 302, and tubing 205, wherein said unitary tube is a barrier traversing tube 305 comprising an outer layer 308, an inner layer 306, and an intermediate oxygen barrier layer 307.
The independent claim defines a blood storage device by combining an oxygen-impermeable outer receptacle, a PVC inner collapsible container doped with a plasticizer, at least one oxygen-impermeable unitary inlet/outlet that is a multilayer barrier-traversing tube, and an oxygen sorbent within the outer receptacle as the core inventive features.
Stated Advantages
Minimizes oxygen ingress into stored blood, especially from tubing, by using oxygen-impermeable outer receptacle, oxygen-impermeable bonds, and barrier-traversing tubing.
Enables extended anaerobic storage performance with headspace PO2 and SO2 stability targets up to 64–84 days and examples maintaining headspace PO2 below 0.8 mmHg for 84 days.
Uses an oxygen sorbent with defined capacities, formats, and adsorption-rate targets to reduce headspace oxygen.
Allows identification and reduction of dominant sources of oxygen ingress, with experimental quantification of materials and seams to select superior barrier materials (RollPrint Clearfoilae Z noted as superior).
Provides options to omit the inner collapsible bag or sorbent if barrier integrity is sufficient.
Integration into collection kits.
Optional oxygen indicators 215 for quality control and monitoring residual oxygen.
Documented Applications
Anaerobic storage of blood with headspace PO2 and SO2 stability targets for extended durations (examples up to 6484 days).
Integration into collection kits.
Use of oxygen indicators for quality control.
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