Irradiation of red blood cells and anaerobic storage

Inventors

Yoshida, TatsuroVernucci, Paul J.

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Assignees

Hemanext Inc

Member
Hemanext
Hemanext

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-11284616-B2

Patent

Publication Date

2022-03-29

Expiration Date


Abstract

A blood storage system comprising: a collection vessel for red blood cells; an oxygen or oxygen and carbon dioxide depletion device; a storage vessel for red blood cells; tubing connecting the collection vessel to the oxygen or oxygen and carbon dioxide depletion device and the oxygen or oxygen and carbon dioxide depletion device to the storage vessel; and a gamma or X-ray irradiating device is used to irradiate red blood cells stored in the vessel, storing red blood cells under anaerobic conditions.

Core Innovation

The invention discloses a blood storage system and methods that combine oxygen and optional carbon dioxide depletion with gamma/X-ray irradiation and anaerobic refrigerated storage. Depletion is effected via cartridges with hollow fibers, flushing gas, or scavenger sorbents and by in-bag sorbent sachets or barrier films. Key device embodiments include pre-storage depletion cartridges (OCDD), integrated unitary cartridges that combine leukoreduction and depletion, and laminated or dual-bag storage bags containing oxygen/CO2 sorbent sachets or barrier films. Operational ranges and performance targets are defined in the specification as [procedural detail omitted for safety].

The invention addresses preservation of red blood cell quality during storage and following irradiation by reducing oxidative damage and metabolic degradation. Experimental data in the specification indicate that anaerobic depletion, with or without carbon dioxide control, preserves ATP and 2,3-DPG and, when combined with irradiation, reduces potassium leakage compared to irradiated aerobic controls, thereby supporting longer functional storage. The specification also contemplates use of additive solutions and in-bag or cartridge sorbents and describes applications including extended storage of irradiated RBCs and prevention of transfusion-associated graft-versus-host disease.

Claims Coverage

Not explicitly described in patent.

Not explicitly described in patent.

Stated Advantages

Preserves ATP and 2,3-DPG levels in stored red blood cells.

Reduces oxidative damage to stored red blood cells.

Reduces potassium (K+) leakage in irradiated units compared to irradiated aerobic controls.

Supports longer functional refrigerated storage of red blood cells.

Enables compatibility of gamma/X-ray irradiation with anaerobic storage.

Documented Applications

Extended storage of irradiated red blood cells.

Prevention of transfusion-associated graft-versus-host disease (TA-GVHD) via provision of gamma-irradiated oxygen- and carbon dioxide-depleted red blood cell units.

Adjustable depletion of oxygen and carbon dioxide for patient needs.

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