Anaerobic blood storage and pathogen inactivation method
Inventors
Sowemimo-Coker, Samuel O. • Sutton, Jeffrey • Yoshida, Tatsuro
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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-10583192-B2
Publication Date
2020-03-10
Expiration Date
Abstract
A method for reducing hemolysis and microparticle formation during storage of pathogen reduced blood. Oxygen reduced blood compositions comprising SAGM and riboflavin having reduced hemolysis. Oxygen reduced blood compositions comprising SAGM and riboflavin having reduced microparticles. Oxygen and pathogen reduced blood compositions comprising CPAD and riboflavin having reduced hemolysis. Oxygen and pathogen reduced blood compositions comprising SAGM and riboflavin having reduced microparticles.
Core Innovation
The invention discloses methods and devices that deoxygenate, and optionally decarbonate, whole blood or blood components prior to pathogen inactivation to substantially reduce hemolysis and microparticle formation and extend storage life. It presents two modalities: a riboflavin plus ultraviolet pathogen reduction process applied to oxygen- or oxygen-and-carbon-dioxide-reduced blood, and amustaline (S303) treatment with glutathione (GSH) applied under oxygen-reduced conditions to improve pathogen inactivation and decrease nonspecific reactions. [procedural detail omitted for safety]
The invention addresses improvement of pathogen inactivation efficacy and preservation of blood quality by performing pathogen reduction under oxygen-reduced conditions. It targets reductions in microparticle formation and hemolysis, preservation or improvement of ATP and 2,3-DPG levels and deformability, and reduction of residual S303 with attendant formation of the S300 degradant, achieved by controlling oxygen (and optionally CO2) and the timing/order of operations. Device and system implementations include bag-based and apheresis architectures with inner and outer bags, oxygen-absorbing sorbents, deoxygenation modules and an ultraviolet chamber, with optional anaerobic storage to preserve the oxygen-reduced state.
Claims Coverage
The disclosure contains four independent claims. The following four inventive features are extracted from those independent claims and their immediate focus areas.
Oxygen removal plus S303 and GSH treatment
Removing oxygen from a blood product prior to pathogen reduction; adding amustaline (S303) to the blood product [procedural detail omitted for safety]; adding glutathione (GSH) to the blood product [procedural detail omitted for safety]; incubating the oxygen-reduced blood product under oxygen-reduced conditions [procedural detail omitted for safety]; whereby residual pathogens are reduced, S303 level is reduced to a non-toxic level, and microparticle formation is reduced compared to S303 treatment under non-oxygen-reduced conditions.
Pathogen-reduced, oxygen-reduced blood product with S303 and gas constraints
A pathogen-reduced, oxygen-reduced blood product characterized by containing amustaline (S303) at a specified concentration [procedural detail omitted for safety], having an oxygen saturation (SO2) below a specified threshold [procedural detail omitted for safety], and having a pCO2 at or below a specified level [procedural detail omitted for safety], with dependent refinements adding glutathione and measurable storage performance improvements.
Method to improve efficacy of S303 pathogen inactivation via oxygen removal
Removing oxygen from a blood product to prepare an oxygen-reduced blood product; adding amustaline (S303) [procedural detail omitted for safety]; adding glutathione (GSH) [procedural detail omitted for safety]; incubating under oxygen-reduced conditions [procedural detail omitted for safety]; whereby residual pathogens are reduced and S303 level is reduced to a non-toxic level.
Oxygen-reduced blood product with higher S300 than S303
A pathogen-reduced, oxygen-reduced blood product having oxygen saturation below a specified threshold [procedural detail omitted for safety], having a pCO2 at or below a specified level [procedural detail omitted for safety], and exhibiting a concentration of the S300 degradant that is greater than the concentration of amustaline (S303), with dependent refinements imposing residual S303 safety limits and reduced microparticle formation relative to non-oxygen-reduced treatment.
The independent claims center on removing oxygen from blood prior to pathogen inactivation combined with S303 and GSH treatment under oxygen-reduced conditions, and on product definitions specifying S303 content and gas constraints, including a state where S300 exceeds S303, with dependent refinements adding glutathione, reduced microparticle formation, safety limits and storage performance improvements.
Stated Advantages
Reduction of residual pathogens following treatment.
Reduction of S303 residual levels to a non-toxic level.
Reduction in microparticle formation compared to S303 treatment under non-oxygen-reduced conditions.
Reduced hemolysis during storage and after treatment.
Extended storage life, including multi-week shelf-life extensions for treated blood products.
Improved metabolic markers and cell quality, including increased ATP and 2,3-DPG and improved deformability after storage.
Improved pathogen inactivation efficacy while decreasing nonspecific reactions associated with S303 chemistry.
Decreased formation or accelerated decomposition of reactive S303 species and related degradants (e.g., S300) over time.
Documented Applications
Deoxygenation and optional decarbonation of whole blood or blood components prior to pathogen inactivation to reduce hemolysis and microparticle formation and extend storage life.
Application of a riboflavin plus ultraviolet pathogen-reduction system to oxygen- or oxygen-and-carbon-dioxide-reduced blood.
Application of amustaline (S303) with glutathione (GSH) to oxygen- or oxygen-and-carbon-dioxide-reduced blood to improve pathogen inactivation and reduce nonspecific reactions.
Bag-based and apheresis system implementations, including inner/outer bag architectures with oxygen-absorbing sorbents, deoxygenation modules and an ultraviolet chamber.
Anaerobic storage of oxygen-reduced, pathogen-reduced blood products to preserve the oxygen-reduced state and benefits.
Use with common transfusion product types explicitly named in claim language, including whole blood, leukoreduced whole blood, plasma, packed red blood cells and platelets.
Improved storage of pathogen-reduced, oxygen-reduced blood products with measurable improvements after cold storage [procedural detail omitted for safety] in selected quality parameters.
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