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-10603417-B2
Publication Date
2020-03-31
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
This disclosure describes an integrated system and method to extend refrigerated red blood cell storage by depleting oxygen and carbon dioxide prior to storage and maintaining an anaerobic environment. Key elements include an O2/CO2 depletion device using gas‑permeable hollow fibers and an O/CD sorbent to strip hemoglobin‑bound O2 [procedural detail omitted for safety], optional leukoreduction or editing, selected additive solutions and antioxidants, and anaerobic storage bags with an inner blood‑compatible bag, an outer oxygen/carbon dioxide barrier film, and a sorbent sachet disposed between them.
The invention addresses limitations in conventional refrigerated red blood cell storage that produce declines in ATP and 2,3‑DPG, increased hemolysis, and reduced post‑transfusion recovery with excess iron. The system intends to maintain ATP and 2,3‑DPG, reduce hemolysis, and extend shelf life [procedural detail omitted for safety], with predicted improved recovery and reduced excess iron after transfusion compared to non‑oxygen depleted red blood cells.
Claims Coverage
The independent claim defines four main inventive features that together form the method for preparing packed red blood cells for transfusion in the treatment of an inherited hemoglobinopathy.
Obtaining whole blood
Obtaining whole blood.
Separating red blood cells to form packed red blood cells
Separating red blood cells from said whole blood to form packed red blood cells.
Depleting oxygen and carbon dioxide from packed red blood cells prior to storage
Depleting oxygen and carbon dioxide from said packed red blood cells prior to storage to prepare depleted packed red blood cells.
Storing depleted packed red blood cells in an anaerobic storage bag with an outer oxygen/carbon dioxide‑impermeable barrier film and an inner bag in contact with said red blood cells
Storing said depleted packed red blood cells in an anaerobic storage bag comprising an outer bag having a barrier film that is impermeable to oxygen and carbon dioxide, and an inner bag in contact with said red blood cells, wherein said depleted packed red blood cells are maintained in an anaerobic condition, to form stored depleted red blood cells.
The independent claim covers obtaining whole blood, forming packed red blood cells, depleting oxygen and carbon dioxide prior to storage, and maintaining depleted packed red blood cells in an anaerobic storage bag having an outer oxygen/carbon dioxide‑impermeable barrier film and an inner bag in contact with the red blood cells.
Stated Advantages
Extended shelf life of refrigerated red blood cells.
Improved maintenance of ATP and 2,3‑DPG during storage.
Reduced hemolysis during storage.
Predicted improved recovery and reduced excess iron after transfusion compared to non‑oxygen depleted red blood cells.
Documented Applications
Preparing red blood cells for transfusion in the treatment of an inherited hemoglobinopathy.
Transfusing the prepared red blood cells into a subject in need thereof.
Extended refrigerated storage of red blood cells in an anaerobic storage bag configuration.
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