Oxygen reduction disposable kits, devices and methods of use thereof
Inventors
Wolf, Michael • SARITA, Jancarlo • Sutton, Jeffrey Karl • Cordero, Rafael • ZOCCHI, Michael • Keegan, Philip • Renganathan, Narendran • Harhen, Robert
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Assignees
MemberHemanextHemanextHemanext 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-11638421-B2
Publication Date
2023-05-02
Expiration Date
Abstract
The present disclosure relates to Oxygen Reduction Disposable kits (ORDKit), devices and methods for the improved preservation of whole blood and blood components. The improved devices and methods for the collection of blood and blood components provide for whole blood and blood components having reduced levels of oxygen. The devices and methods provide for the rapid preparation of deoxygenated blood and blood components for storage that improves the overall quality of the transfused blood and improves health outcomes in patients.
Core Innovation
The invention describes an oxygen reduction storage system for rapid deoxygenation of collected blood and storage of oxygen-depleted blood. The system comprises an outer receptacle substantially impermeable to oxygen, an inner collapsible oxygen-permeable blood container, an oxygen sorbent situated between them, and a mesh spacer that maintains a headspace. The mesh interstices comprise 50% to 80% of the total area to ensure efficient diffusion of oxygen from the container surface to the sorbent.
The system combines an oxygen depletion component and an anaerobic blood storage component interconnected via tubing and sealed bonds. Each component positions the inner collapsible blood container inside the outer receptacle and uses a headspace containing the oxygen sorbent to promote diffusion-driven oxygen removal. Inlet/outlets with tubing include a bond to the outer receptacle that is substantially impermeable to oxygen to enable depleting oxygen and subsequent anaerobic storage.
The disclosure addresses venous oxygen saturation in collected blood of approximately 30–70% and oxygen-associated storage lesions that impair transfusion quality and outcomes, initiating oxygen reduction at donor collection. The patent specifies microporous membrane materials for the inner container, including PVDF, polysulfone, polyolefin, and PTFE. Operational performance parameters and example procedural steps are disclosed [procedural detail omitted for safety], along with device geometry, materials, surface-to-volume ratio thresholds, and sorbent capacities as process levers.
Claims Coverage
This coverage addresses one independent claim with seven main inventive features.
Outer receptacle substantially impermeable to oxygen
An outer receptacle that is substantially impermeable to oxygen and defines a headspace around the inner collapsible blood container in which the oxygen sorbent is situated.
Inner collapsible oxygen-permeable blood container
An inner collapsible blood container comprising one or more chambers that are permeable to oxygen and positioned inside the outer receptacle to permit diffusion from the blood to the container surface.
Inlet/outlets with tubing and oxygen-impermeable bond
At least one inlet/outlet comprising tubing connecting to the collapsible inner blood container and a bond to the outer receptacle, wherein the bond to the outer receptacle is substantially impermeable to oxygen.
Oxygen sorbent situated between receptacle and container
An oxygen sorbent positioned between the outer receptacle and the inner collapsible blood container to remove oxygen from the headspace between them.
Spacer mesh maintaining headspace with specified interstices
A spacer that is a mesh comprising at least one interstice that maintains a headspace defined by the outer receptacle and the collapsible blood container, wherein the interstice comprises between 50% to 80% of the total area of the mesh to ensure efficient diffusion of oxygen from the blood container surface to the oxygen sorbent.
Anaerobic blood storage component mirroring depletion component
An anaerobic blood storage component comprising an outer receptacle substantially impermeable to oxygen, a collapsible blood container, a set of inlet/outlets with a substantially impermeable bond to the outer receptacle, an oxygen sorbent situated between the receptacle and the container, and a spacer mesh with specified interstice area.
Dual-component integration for depletion and storage
A system architecture combining an oxygen depletion component and a separate anaerobic blood storage component interconnected via tubing and sealed bonds to enable depleting oxygen from collected blood and transferring or storing the oxygen-depleted blood within the system.
The independent claim recites a two-part system integrating oxygen-impermeable outer receptacles, inner collapsible oxygen-permeable blood containers, inlet/outlet tubing with oxygen-impermeable bonds, oxygen sorbents positioned between container and receptacle, and mesh spacers with 50% to 80% interstice area to maintain headspaces that drive diffusion for oxygen removal and support subsequent anaerobic storage.
Stated Advantages
Rapid deoxygenation of collected blood prior to storage.
The spacer-maintained headspace ensures efficient diffusion of oxygen from a surface of the inner collapsible blood container to the oxygen sorbent.
Outer receptacles that are substantially impermeable to oxygen enable anaerobic storage of oxygen-depleted blood.
Provides extended anaerobic storage performance as exemplified by a dependent claim requiring oxygen-depleted blood in the collapsible container to maintain PO2 below a specified threshold for a prolonged storage period (up to 64 days as claimed).
Initiate oxygen reduction at donor collection.
Reduce storage lesions and improve transfusion quality and outcomes.
Documented Applications
Oxygen-reduction disposable kits and devices (ORDKit) to deoxygenate whole blood at collection.
Anaerobic storage of oxygen-depleted blood maintaining PO2 <15 mmHg for a storage period of up to 64 days.
Use with collected blood types including whole blood, LRpRBC, pRBC, and packed RBCs.
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