Chemistry: analytical and immunological testing – Biological cellular material tested
Reexamination Certificate
1999-04-21
2001-02-20
Wallenhorst, Maureen M. (Department: 1743)
Chemistry: analytical and immunological testing
Biological cellular material tested
C436S164000, C436S165000, C436S052000, C422S051000, C422S073000, C422S081000, C422S082050, C356S039000, C356S317000, C356S318000, C356S335000, C356S336000, C356S337000
Reexamination Certificate
active
06190919
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention generally relates to the deglycerolization of blood, and more particularly, to a system which controls the deglycerolization of blood by monitoring the segregation of erythrocytes by size.
The Armed Services Blood Program Office (ASBPO) has established a policy of maintaining pre-positioned stockpiles of frozen red blood cells, and utilizing these stockpiles in times of conflict for U.S. combat casualties. In order to implement this policy, glycerol is allowed to be absorbed by red blood cells, which then are frozen and stored. The glycerol prevents damage to the erythrocytes. Presently, the only method approved by the Food and Drug Administration (FDA) for processing thawed-frozen red blood cells uses an open, nonsterile wash system that is manually monitored and operated. This system generally requires about 1½ to 2 hours to thaw and deglycerolize red blood cells from a cryogenic state. Because this system is not sterile, the FDA mandates that thawed-frozen red blood cells processed this way must be transfused within 24 hours or discarded. However, the time restrictions and requirement to discard the blood are not compatible with the logistics of the ASBPO policy. Therefore, a need exist for a sterile, automated method for monitoring and controlling the deglycerolization of thawed red blood cells in a more timely manner compared to the processing time of the standard method.
SUMMARY OF THE INVENTION
The present invention provides a system and method for controlling the deglycerolization of red blood cells. A system for controlling the deglycerolization of red blood cells includes a cell sorter having multiple fluid channels each having a unique cross-sectional area for directing a fluid mixture consisting essentially of a saline solution and a plasma solution having glycerized red blood cell products through one or more of the fluid channels based on the sizes of the red blood cell products. An optical energy source illuminates the fluid mixture in the cell sorter, whereupon an optical detector generates a data signal in response to receiving light signals that propagate through the fluid mixture. A processor generates a control signal in response to receiving the data signal that is used by a servo-controlled device to control the ratio of the saline and plasma solutions in the fluid mixture so that the red blood cell products substantially flow only through one or more of the fluid channels having particular cross-sectional areas.
These and other advantages of the invention will become more apparent upon review of the accompanying drawings and specification, including the claims.
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Copeland Hugh D.
Mastny Gary F.
Patterson Andrew E.
Fendelman Harvey
Kagan Michael A.
Lipovsky Peter A.
The United States of America as represented by the Secretary of
Wallenhorst Maureen M.
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