Manual processing systems and methods for providing blood components conditioned for pathogen inactivation

Abstract

Systems and methods manually process blood and blood components in sterile, closed environments, which further condition the blood components for subsequent pathogen inactivation processes. The systems and methods mate the manual collection of random donor platelet units with the creation of larger therapeutic doses of platelets targeted to undergo pathogen inactivation prior to long term storage and/or transfusion.

1 - 6 . (canceled)  
   
   
       7 . A platelet pooling assembly comprising 
 a manifold sized and configured to convey multiple platelet concentrate mixtures from a plurality of platelet concentrate units, said platelet concentrate comprising a platelet concentrate volume, a plasma volume, and a synthetic platelet additive solution volume,    a container coupled to the manifold for pooling the multiple platelet concentrate mixtures.    
   
   
       8 . A platelet pooling assembly according to  claim 7   wherein the container includes an appendage sized and configured for coupling the container to a source of the selected pathogen inactivating compound.    
   
   
       9 . A platelet pooling assembly according to  claim 7  further including a filter for removing leukocytes from platelets.  
   
   
       10 . A platelet pooling assembly comprising 
 a manifold sized and configured to convey multiple platelet concentrate mixtures from a plurality of a platelet concentrate units as defined in  claim 7 , and    a first container coupled to the manifold for pooling the multiple platelet concentrate mixtures, and    a second container coupled to the first container to receive the multiple platelet concentrate mixtures after centrifugation in the first container to remove residual red blood cells.    
   
   
       11 . A platelet pooling assembly according to  claim 10   wherein the second container includes an appendage sized and configured for coupling the second container to a source of the selected pathogen inactivating compound.    
   
   
       12 . A platelet pooling assembly according to  claim 10   further including a filter for removing leukocytes from platelets.    
   
   
       13 . A platelet pooling assembly comprising 
 a first container for receiving a concentration of platelets, and    a second container integrally coupled by tubing to the first container to receive the concentration of platelets after centrifugation in the first container to remove residual red blood cells.    
   
   
       14 . A platelet pooling assembly according to  claim 13   wherein the first container includes a region of reduced volume to collect the residual red blood cells.    
   
   
       15 . A platelet pooling assembly according to  claim 13   wherein the first container includes a region of reduced volume to concentrate the residual red blood cells.    
   
   
       16 . A platelet pooling assembly according to  claim 13   further including a third container integrally coupled by tubing to the first container to receive the separated residual red blood cells.    
   
   
       17 . A platelet pooling assembly according to  claim 16   further including a one-way valve in the tubing between the first and third container to resist fluid flow from the third container toward the first container.    
   
   
       18 . A platelet pooling assembly according to  claim 13   wherein the tubing carries an in-line filter to remove leukocytes from platelets.    
   
   
       19 . A platelet pooling assembly comprising 
 a manifold sized and configured to receive multiple platelet concentrate units that have centrifugally separated from individual random donors, the manifold further including a site to receive a synthetic platelet additive solution for mixing with the multiple platelet concentrate units, and    a container coupled to the manifold for pooling a mixture of the multiple platelet concentrate units and the synthetic platelet additive solution.    
   
   
       20 . A platelet pooling assembly according to  claim 19   wherein the synthetic platelet additive solution volume includes ingredients that condition the multiple platelet concentrate units for pathogen inactivation in the presence of a selected pathogen inactivating compound.    
   
   
       21 . A platelet pooling assembly according to  claim 20   wherein the ingredients comprise an aqueous solution including sodium chloride, sodium citrate, sodium acetate, and sodium phosphate.    
   
   
       22 . A platelet concentrate unit according to  claim 20   wherein the selected pathogen inactivating compound is selected from a group comprising psoralens, methylene blue, dimethyl-methylene blue, riboflavin, or PEN  110 , or combinations thereof.    
   
   
       23 . A platelet pooling assembly according to  claim 20   wherein the container includes an appendage sized and configured for coupling the container to a source of the selected pathogen inactivating compound.    
   
   
       24 . A platelet pooling assembly according to  claim 19   further including a filter for removing leukocytes from platelets.    
   
   
       25 . A platelet pooling assembly according to  claim 19   further including a second container coupled by tubing to the first container to receive the mixture after separation of residual red blood cells.    
   
   
       26 . A platelet pooling assembly according to  claim 25   further including a filter for removing leukocytes from platelets.    
   
   
       27 - 42 . (canceled)  
   
   
       43 . A system for collecting a pooled therapeutic platelet unit conditioned for pathogen inactivation from random donor platelet units comprising 
 means for collecting from a unit of whole blood drawn from an individual donor and processed by centrifugation in a sterile, closed blood collection system, a random donor sterile platelet component unit that has been conditioned for pathogen inactivation by the mixing, in the sterile, closed blood processing system, of a prescribed platelet additive solution, and    means for pooling in a sterile, closed system a plurality of random donor sterile platelet component units to provide a pooled random donor sterile platelet component dose that is conditioned for pathogen inactivation due to the presence of the platelet additive solution.    
   
   
       44 . A system according to  claim 43   further including means for subjecting the pooled random donor sterile platelet component dose to closed system leukocyte filtration.    
   
   
       45 . A system according to  claim 43   further including means for subjecting the random donor sterile platelet component unit to closed system leukocyte filtration.    
   
   
       46 . A system according to  claim 43   further including means for mixing with the pooled random donor sterile platelet component dose a desired volume of a pathogen inactivating compound to provide a treatment-ready pooled random donor dose.    
   
   
       47 . A system according to  claim 46   further including means for subjecting the treatment-ready pooled random donor dose to pathogen decontamination.    
   
   
       48 . A system for collecting a pooled therapeutic platelet unit conditioned for pathogen inactivation from random donor platelet units comprising 
 means for collecting from a unit of whole blood drawn from an individual donor and processed by centrifugation in a sterile, closed blood collection system, a random donor sterile platelet component unit, and    means for pooling in a sterile, closed system a plurality of random donor sterile platelet component units, while also mixing, in the sterile, closed system, a prescribed platelet additive solution, to provide a pooled random donor sterile platelet component dose that is conditioned for pathogen inactivation due to the presence of the platelet additive solution.    
   
   
       49 . A system according to  claim 48   further including means for subjecting the pooled random donor sterile platelet component dose to closed system leukocyte filtration.    
   
   
       50 . A system according to  claim 48   further including means for subjecting the random donor sterile platelet component unit to closed system leukocyte filtration.    
   
   
       51 . A system according to  claim 48   further including means for mixing with the pooled random donor sterile platelet component dose a desired volume of a pathogen inactivating compound to provide a treatment-ready pooled random donor dose.    
   
   
       52 . A system according to  claim 51   further including means for subjecting the treatment-ready pooled random donor dose to pathogen decontamination.    
   
   
       53 - 55 . (canceled)  
   
   
       56 . A method for collecting a pooled therapeutic platelet unit conditioned for pathogen inactivation from random donor platelet units comprising the steps of 
 collecting from a unit of whole blood drawn from an individual donor and processed by centrifugation in a sterile, closed blood collection system, a random donor sterile platelet component unit that has been conditioned for pathogen inactivation by the mixing, in the sterile, closed blood processing system, of a prescribed platelet additive solution, and    pooling in a sterile, closed system a plurality of random donor sterile platelet component units to provide a pooled random donor sterile platelet component dose that is conditioned for pathogen inactivation due to the presence of the platelet additive solution.    
   
   
       57 . A method according to  claim 56   further including the step of subjecting the pooled random donor sterile platelet component dose to closed system leukocyte filtration.    
   
   
       58 . A method according to  claim 56   further including the step of subjecting the random donor sterile platelet component unit to closed system leukocyte filtration.    
   
   
       59 . A method according to  claim 56   further including the step of mixing with the pooled random donor sterile platelet component dose a desired volume of a pathogen inactivating compound to provide a treatment-ready pooled random donor dose.    
   
   
       60 . A method according to  claim 59   further including the step of subjecting the treatment-ready pooled random donor dose to pathogen decontamination.    
   
   
       61 . A method for collecting a pooled therapeutic platelet unit conditioned for pathogen inactivation from random donor platelet units comprising the steps of 
 collecting from a unit of whole blood drawn from an individual donor and processed by centrifugation in a sterile, closed blood collection system, a random donor sterile platelet component unit, and    pooling in a sterile, closed system a plurality of random donor sterile platelet component units, while also mixing, in the sterile, closed system, a prescribed platelet additive solution, to provide a pooled random donor sterile platelet component dose that is conditioned for pathogen inactivation due to the presence of the platelet additive solution.    
   
   
       62 . A method according to  claim 61   further including the step of subjecting the pooled random donor sterile platelet component dose to closed system leukocyte filtration.    
   
   
       63 . A method according to  claim 61   further including the step of subjecting the random donor sterile platelet component unit to closed system leukocyte filtration.    
   
   
       64 . A method according to  claim 61   further including the step of mixing with the pooled random donor sterile platelet component dose a desired volume of a pathogen inactivating compound to provide a treatment-ready pooled random donor dose.    
   
   
       65 . A method according to  claim 64   further including the step of subjecting the treatment-ready pooled random donor dose to pathogen decontamination.