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
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-11375709-B2
Publication Date
2022-07-05
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 provides a device and system for depleting oxygen from blood by enclosing an inner collapsible blood container within an outer receptacle substantially impermeable to oxygen and positioning an oxygen sorbent between them. A spacer that is a mesh preserves a headspace to enable diffusion from the blood container surface to the sorbent. The disclosure describes membrane materials, mesh-integrated spacers, sorbent sachets, kit configurations, and optional components such as an oxygen indicator and tubing.
The invention addresses accelerating depletion of dissolved oxygen from collected blood and preparing oxygen-reduced whole blood and blood components at collection. It identifies materials, geometries, placements, and performance targets that improve deoxygenation, including effective surface-to-volume ratios, membrane permeability and materials, spacer geometry to maintain headspace, and sorbent placement. Methods, operating parameters, and quantitative targets are described [procedural detail omitted for safety].
Claims Coverage
The patent includes one independent claim that recites five main inventive features combining structural components to enable oxygen depletion from blood.
Oxygen-impermeable outer receptacle
An outer receptacle substantially impermeable to oxygen.
Inner collapsible blood container comprising PVC or polyolefin
An inner collapsible blood container comprising one or more chambers comprising polyvinyl chloride (PVC) or polyolefin.
Mesh spacer that maintains a headspace
A spacer that is a mesh comprising at least one interstice and maintains a headspace defined by the outer receptacle and the inner collapsible blood container.
Mesh interstice open-area of 50% to 80%
Wherein the at least one interstice comprises between 50% to 80% of the total area of the mesh material.
Oxygen sorbent positioned between outer receptacle and inner collapsible blood container
An oxygen sorbent situated between the outer receptacle and the inner collapsible blood container such that the headspace ensures diffusion of oxygen from a surface of the inner collapsible blood container to the oxygen sorbent.
The independent claim covers the combination of an oxygen-impermeable outer receptacle, a PVC or polyolefin inner collapsible blood container, a meshed spacer with specified open-area that maintains a headspace, and an oxygen sorbent positioned to receive oxygen diffusing from the container surface.
Stated Advantages
Accelerated depletion of dissolved oxygen from blood through combined design features and process variables.
Ensures efficient diffusion of oxygen from the surface of the inner collapsible blood container to the oxygen sorbent via the preserved headspace.
Practical oxygen-impermeable collection kit configurations with quantified sorbent capacities to support oxygen depletion.
Improved deoxygenation performance through selection of membrane material, surface-to-volume ratios, spacer integration, and sorbent placement.
Enables preparing oxygen-reduced whole blood and blood components at collection.
Supports achieving specified deoxygenation targets for reduced O2 saturation to enable anaerobic storage concepts.
Documented Applications
Depleting oxygen from blood.
Preparing oxygen-reduced whole blood and blood components at collection.
Oxygen-impermeable collection kit enclosures for blood deoxygenation and storage.
Blood storage device 20 and anaerobic storage concepts.
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