Oxygen reduction disposable kits, devices and methods of use thereof (ORDKit)
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-11350626-B2
Publication Date
2022-06-07
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 patent describes an oxygen depletion device comprising an outer receptacle substantially impermeable to oxygen and carbon dioxide, an inner collapsible blood container of a material having a permeability to oxygen of at least 25 Barrer, a mesh spacer maintaining a headspace, and an oxygen sorbent in the headspace. A method uses this device by [procedural detail omitted for safety] to produce oxygen-reduced blood having less than 20% oxygen saturation.
The invention addresses depleting oxygen and carbon dioxide from collected whole blood prior to storage or processing. The combination of an oxygen-impermeable outer barrier, a headspace with an interstitial mesh spacer, placement of oxygen sorbent in the headspace, and an inner container material composition improves deoxygenation kinetics, prevents oxygen ingress, and enables efficient diffusion to the sorbent, with spacer, surface-area-to-volume, and mixing considerations linked to performance.
The specification discloses targeted barrier and membrane permeability characteristics, geometric and mixing structures to avoid dead zones, spacer constructions that sustain gas diffusion to the sorbent, and sorbent formulations and packaging. Accessory elements such as indicator inclusion and controlled inlet/outlet sealing support device performance and storage outcomes, while procedural steps and operational parameters are omitted.
Claims Coverage
The patent includes two independent claims directed to an oxygen depletion device and a method to prepare blood for storage, summarized across five principal inventive features.
Outer receptacle substantially impermeable to oxygen and carbon dioxide
A receptacle substantially impermeable to oxygen and carbon dioxide enclosing the inner collapsible blood container and headspace.
Inner collapsible blood container having specified oxygen permeability
An inner collapsible blood container comprising one or more chambers comprising a material having a permeability to oxygen of at least 25 Barrer.
Spacer as a mesh maintaining a headspace with defined interstice area
A spacer situated between the outer receptacle and the inner collapsible blood container, wherein the spacer is a mesh comprising at least one interstice and maintains a headspace, and wherein the at least one interstice comprises between 50% to 80% of the total area of the mesh material of the spacer.
Oxygen sorbent situated in the headspace between outer receptacle and inner container
An oxygen sorbent situated between the outer receptacle and the inner collapsible blood container such that the headspace ensures efficient diffusion of oxygen from a surface of the inner collapsible blood container to the oxygen sorbent.
Flowing blood into inner collapsible blood container to produce oxygen-reduced blood
A method that provides the oxygen depletion device as claimed and [procedural detail omitted for safety], producing oxygen-reduced blood having less than 20% oxygen saturation.
The independent claims protect a device defined by an oxygen- and carbon-dioxide-impermeable outer receptacle, an inner collapsible blood container with at least 25 Barrer oxygen permeability, a mesh spacer maintaining a headspace with 50–80% interstice area, and an oxygen sorbent located in that headspace; the method claim adds [procedural detail omitted for safety] to obtain blood with less than 20% oxygen saturation.
Stated Advantages
Reduction of collected whole blood oxygen saturation to low levels (for example to less than 20%) to prepare blood for storage.
Improved deoxygenation kinetics and performance through use of a mesh spacer maintaining a headspace, favorable surface-area-to-volume geometry, and mixing considerations that increase diffusion to the sorbent.
Prevention of oxygen ingress and maintenance of a controlled headspace by use of an outer receptacle substantially impermeable to oxygen and carbon dioxide and oxygen-impermeable inlet/outlet components.
Placement of oxygen (and optionally carbon dioxide) sorbent in the headspace to enable efficient diffusion from the inner collapsible blood container to the sorbent.
Sorbent formulations and sachet packaging that allow defined oxygen uptake capacity and placement in the headspace.
Inclusion of oxygen indicator and controlled inlet/outlet sealing to support device performance and shelf life targets.
Documented Applications
Preparing blood for storage, including preparing blood for anaerobic storage.
Depleting oxygen and carbon dioxide from blood.
Deoxygenating blood collected in the device.
Storage of oxygen-reduced blood [procedural detail omitted for safety].
Blood collection kit concepts comprising an oxygen-impermeable enclosure with oxygen sorbent placed in the headspace and integrated inlet/outlet and bag components for collection and oxygen depletion.
Considerations for additive bags and integration with the oxygen depletion device in blood collection workflows.
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