Gas depletion and gas addition devices for blood treatment
Inventors
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Assignees
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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-10687526-B2
Publication Date
2020-06-23
Expiration Date
Abstract
Devices for the preparation of depleted blood products that provide for the depletion of oxygen, carbon dioxide, or oxygen and carbon dioxide are described. In addition, devices for the replenishment of oxygen and other gases to an anaerobic blood product are described. Methods and systems incorporating depletion and addition devices are provided to optimize the preparation, storage and transfusion of blood products to a recipient are described.
Core Innovation
The invention discloses integrated devices, methods and systems to deplete and later re-add gases to blood products to enable extended anaerobic storage and controlled re-oxygenation prior to transfusion. A device architecture comprises an enclosure with one or more liquid chambers separated from gas-depletion or gas-addition chambers by at least one gas-permeable barrier. Internal flow-control features induce mixing and disrupt laminar flow to enhance gas transfer, reducing storage lesions and extending shelf-life and quality.
The disclosure provides multiple device configurations, including rigid and flexible enclosures, with chamber geometries and stacking, parallel or series arrangements to tune depletion and addition performance. It describes O2 and CO2 diffusion to depletion media or flowing depletion gas and re-oxygenation via gas addition ports. Integrations include plasma separation using plasma porous hydrophobic or hydrophilic membranes, leukoreduction media, and combined devices for depletion and reoxygenation.
The invention presents a workflow from collection through storage under reduced-gas conditions and final gas restoration before transfusion. It reports experimental deoxygenation performance for prototype devices with measured metrics including pO2 in/out, ΔpO2, % O2 reduction, and % SO2 across multiple runs. It notes measurement discrepancies and rapid reoxygenation of red blood cells after removal from an anaerobic environment.
Claims Coverage
One independent claim is present and it defines a gas addition device for adding gas to a blood product, reciting five main inventive features.
Gas addition device for adding gas to a blood product
A gas addition device for adding gas to a blood product comprising an enclosure.
Liquid chambers with flow control features that disrupt laminar flow
One or more liquid chambers that further comprise one or more flow control features that disrupt laminar flow and wherein the one or more flow control features are half the height of the one or more liquid chambers and are the width of the one or more liquid chambers.
Two or more gas addition chambers
Two or more gas addition chambers contained in the enclosure.
Gas-permeable barrier separating liquid and gas chambers
At least one gas permeable barrier separating at least one of the one or more liquid chambers from the two or more gas addition chambers.
Liquid inlet and liquid outlet
At least one liquid inlet and at least one liquid outlet.
The independent claim covers an apparatus for adding gas to a blood product, comprising an enclosure with liquid chambers that include specified flow-control features, multiple gas addition chambers, at least one gas-permeable barrier between liquid and gas chambers, and liquid inlet(s)/outlet(s).
Stated Advantages
Extended anaerobic storage of blood products.
Controlled re-oxygenation prior to transfusion.
Reducing storage lesions and extending shelf-life and quality of red blood cells and other blood products for safer transfusion.
Flow-control features that disrupt laminar flow to enhance gas transfer.
Tunable depletion/addition performance via chamber geometries and stacking/parallel/series arrangements.
Documented Applications
Gas depletion devices.
Plasma separation.
Leukoreduction.
Preparing anaerobic/CO2-depleted blood.
Extended anaerobic storage.
Re-oxygenation (and NO addition) prior to transfusion.
Reducing storage lesions and extending shelf-life and quality of red blood cells and other blood products for safer transfusion.
A method of preparing a blood product for transfusion by flowing the blood product through the device to produce a blood product with an increased level of gas (deplete 2 store 2 re-add gas).
Combined processing including leukoreduction, plasma removal, editing, pathogen inactivation, and irradiation.
A system workflow from collection through storage and final gas restoration.
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