System for extended storage of red blood cells and methods of use
Inventors
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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-12502462-B2
Publication Date
2025-12-23
Expiration Date
Abstract
A system and methodology for the preservation of red blood cells is described in which red blood cells are oxygen or oxygen and carbon dioxide depleted, treated and are stored in an anaerobic environment to optimize preparation for transfusion. More particularly, a system and method for extended storage of red blood cells from collection to transfusion that optimizes red blood cells prior to transfusion is described.
Core Innovation
The disclosure describes an integrated method and disposable apparatus for extended anaerobic storage and preparation of red blood cells. The core innovations include an oxygen/carbon-dioxide depletion device (OCDD) employing gas-permeable hollow fibers/films together with an O2/CO2 sorbent to strip hemoglobin-bound gas prior to storage, an anaerobic storage bag architecture comprising an inner blood-compatible bag and an outer oxygen-barrier film containing a sorbent sachet, additive formulations and metabolic supplements optimized for anaerobic storage, modular workflow steps for editing and processing, and combined multifunction devices that integrate plasma separation, leukoreduction and OCDD.
The disclosure addresses limitations of standard refrigerated red blood cell storage by providing anaerobic removal of hemoglobin-bound gases and an anaerobic storage environment to mitigate storage lesion and preserve in-vitro quality metrics. Reported technical advantages include maintained or high ATP and 2,3-DPG, reduced hemolysis, and extended refrigerated shelf life (examples: about 7–15 weeks and up to about 20+ weeks) compared with standard six-week storage. The disclosure also gives device design parameters and process timing recommendations [procedural detail omitted for safety].
Claims Coverage
The patent contains two independent method claims directed to workflows for editing and storing red blood cells. The claims recite 4 main inventive features that focus on (1) gas depletion via a disposable-housed device with gas-permeable membranes and an oxygen sorbent, (2) an anaerobic storage bag architecture with an oxygen-impermeable outer barrier and inner bag contacting the red blood cells, (3) editing to identify and remove moribund/dead/dying red blood cells, and (4) leukoreduction at various stages.
Oxygen depletion device with gas-permeable membranes and oxygen sorbent
Depleting oxygen comprises passing the packed red blood cells through a device having a disposable housing, an inlet port, an outlet port, one or more gas permeable membranes adapted to receiving and conveying red blood cells, and an oxygen sorbent.
Anaerobic storage bag with outer oxygen barrier and inner blood bag
Storing under anaerobic conditions in an anaerobic storage bag comprising an outer bag having a barrier film that is impermeable to oxygen and an inner bag in contact with the packed red blood cells to form stored depleted red blood cells.
Editing to remove moribund, dead, or dying red blood cells
Editing comprises identifying and removing moribund, dead, or dying red blood cells from the stored or packed red blood cells to form stored edited and depleted packed red blood cells. Performing the editing step to identify and remove moribund, dead, or dying red blood cells from the packed red blood cells before depleting oxygen by passing the packed red blood cells through the device having a disposable housing, gas permeable membranes, and an oxygen sorbent.
Leukoreduction at selectable stages
Leukoreducing the whole blood, the packed red blood cells, the edited packed red blood cells, or the edited and depleted packed red blood cells.
The independent claims cover methods that combine separation and optional leukoreduction, targeted removal of moribund/dead/dying red blood cells, gas depletion through a disposable device with gas-permeable membranes and an oxygen sorbent, and anaerobic storage in a dual-bag architecture with an oxygen-impermeable outer barrier and inner blood bag.
Stated Advantages
Maintained or high ATP and 2,3-DPG levels during storage.
Reduced hemolysis compared with standard storage.
Extended refrigerated shelf life for red blood cells (examples reported: about 7–15 weeks, up to about 20+ weeks) compared with standard six-week storage.
Improved in-vitro quality metrics as supported by reported figures/data (ATP, DPG, hemolysis).
Combined multifunction devices that integrate plasma separation, leukoreduction and OCDD to avoid centrifugation.
Documented Applications
Extended anaerobic storage and preparation of red blood cells.
Modular workflow steps for red blood cell processing [procedural detail omitted for safety].
Disposable and combined multifunction devices that integrate plasma separation, leukoreduction and oxygen/carbon-dioxide depletion to avoid centrifugation.
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