Blood component separation method and apparatus

#The following invention relates generally to instrumentalities and methodologies in blood component separation techniques. More specifically, the instant invention is directed to a method and apparatus for collecting a blood sample and subsequently separating the collected sample into the blood components for individual storage or use.

#Blood collection is always important, particularly in times of emergency (immediate use), but whole blood may only be stored for about 30 days before it is “outdated”. For long term storage, the ability to separate the whole blood into its major components (white blood cells, platelets, red blood cells and plasma) is of paramount importance because the long term storage conditions for each component is different in terms of temperature and storage media. The most important component separations occurring after collection is the separation of red blood cells (RBC), white blood cells (WBC), platelets, and plasma from one another. Within the WBC it is sometimes important to separate the granulocytes from the lymphocytes. After separation and extraction of particular components, a fraction of the blood may be returned to the patient.

#It is possible to separate the various components of whole blood either under or after centrifugation, due to their differing densities. Some prior art methods, such as that in U.S. Pat. No. 4,120,448, utilize a chamber connected to a centrifuge. The centrifuged blood separates in the chamber, and a plurality of collection means are positioned at various locations in the chamber corresponding to the areas where each component congregates, which is density-dependent.

#FIG. 1 depicts the bag set of the present invention.

#FIGS. 2A and 2B depict the clamshell container before insertion of the bag set.

#FIGS. 3A-3C depict the clamshell bag holder after insertion of the bag set.

#Considering the drawings, wherein like reference numerals denote like parts throughout the various drawing figures, reference numeral 10 as shown in FIG. 1 is directed to the bag set according to the present invention.

#Referring to FIG. 1, the bag set 10 includes a whole blood collection bag 2, a red blood cell (RBC) bag 4, and a freezing bag 6 for the collection and storage of white blood cells. The collection bag 2 is supplied through an inlet line 12, preferably through a phlebotomy needle 8. The collection bag 2 has an outlet 26, which directs output into a three-way metering valve 20 through a spike 30 (which is inserted into outlet 26) which is connected to an outlet line 32. The operation positions of the metering valve 20 are shown in FIGS. 9A-9C. Two supply lines 24a,24b lead from the metering valve 20 to the RBC bag 4 and the freezing bag 6, respectively. RBC supply line 24a has an optional HES inlet 14 for the introduction of a sedimenting agent, such as hydroxyethyl starch (HES) into the system. The freezing bag supply line 24b has an optional cryoprotectant inlet 16 for the introduction of cryoprotectant into the system. The HES inlet 14 and the cryoprotectant inlet 16 are each equipped with a filter 18, preferably a 0.2μ filter, to, inter alia, prevent contamination from pathogens in the outside air and to allow venting of air from the freezing bag and tubing. The supply lines 24a,24b and the inlet line 12 may each be heat sealed and separated from the bag set 10. All lines are equipped with line clamps 22 that may be closed to prevent fluid passage when desired. If other components are to be separated, the bag set 10 may include additional bags 200, and the metering valve 20 may be modified to accommodate the additional bags 200.

#Initially, the collection bag 2 is filled with an anticoagulant, such as CPD (citrate, phosphate, and dextrose). The metering valve 20 begins in the closed position (FIG. 9A). All clamps 22 are closed, with the exception of the clamp 22 on the inlet line 12. Blood, preferably whole, placental, or umbilical cord blood, is obtained from a source through the phlebotomy needle 8 or other appropriate inlet, which feeds into the collection bag 2 through the inlet line 12. The inlet line 12 is then clamped, heat sealed, and separated from the bag set 10. The clamps 22 on the HES inlet line 14 are opened, and HES is introduced through the HES inlet 14 into bag 2. The line leading to the HES inlet 14 is then clamped, heat sealed, and removed. Alternatively, the HES can be introduced into the bag 2 earlier, as, for example, during manufacture.