System for extended storage of red blood cells and methods of use
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-11433164-B2
Publication Date
2022-09-06
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 invention provides an integrated system and methods for anaerobic preservation of packed red blood cells for transfusion in the treatment of sickle cell. Packed red blood cells are oxygen- or oxygen-and-carbon-dioxide-depleted using [procedural detail omitted for safety] and are placed into an anaerobic storage bag comprising an inner blood-compatible bag and an outer barrier film with an interposed sorbent sachet so that the depleted packed red blood cells are maintained in an anaerobic condition.
The invention addresses deterioration associated with conventional refrigerated storage of packed red blood cells by maintaining or enhancing ATP and 2,3-DPG, reducing hemolysis, and extending refrigerated shelf-life with examples reported up to approximately 10–20 weeks versus conventional storage. The system and methods contemplate optional pre- and post-storage processing steps [procedural detail omitted for safety] and re-oxygenation immediately before transfusion to produce transfusable, oxygenated red blood cells.
Claims Coverage
The relevant independent claims are two methods. The summary extracts five main inventive features across these independent claims.
Obtaining whole blood and forming packed red blood cells
Obtaining whole blood and separating red blood cells from said whole blood to form packed red blood cells.
Depletion of 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.
Anaerobic storage bag that maintains an anaerobic condition
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.
Use of previously stored oxygen- and carbon-dioxide-depleted packed red blood cells
Obtaining previously stored oxygen and carbon dioxide depleted packed red blood cells that were depleted prior to storage and stored in an anaerobic storage bag comprising an outer bag with a barrier film impermeable to oxygen and carbon dioxide and an inner bag in contact with said depleted packed red blood cells.
Oxygenation of previously stored depleted red blood cells prior to transfusion
Oxygenating said previously stored depleted red blood cells to create oxygenated red blood cells and transfusing said red blood cells into a subject in need thereof.
The independent claims cover methods that deplete oxygen and carbon dioxide from packed red blood cells before storage in a two-bag anaerobic storage assembly and methods that retrieve, oxygenate, and transfuse previously stored oxygen- and carbon-dioxide-depleted packed red blood cells.
Stated Advantages
Maintains or enhances ATP and 2,3-DPG levels in stored packed red blood cells.
Reduces hemolysis during storage relative to conventional storage.
Extends refrigerated shelf-life of packed red blood cells with examples reported up to approximately 10–20 weeks versus conventional storage.
Provides higher 24-hour post-transfusion recovery and reduced excess iron compared to red blood cells that are not oxygen depleted.
Documented Applications
Preparing red blood cells for transfusion in the treatment of sickle cell in a subject in need thereof.
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