Devices, systems, and methods for reducing levels of pro-inflammatory or anti-inflammatory stimulators or mediators in blood products

Abstract

Devices, systems, and methods reduce levels of pro-inflammatory or anti-inflammatory stimulators or mediators in blood by selective adsorption. The devices, systems, and methods are useful in situations where abnormal levels of or unregulated or excessive interaction among pro-inflammatory or anti-inflammatory stimulators or mediators occur, or during events that do induce or have the potential for inducing abnormal production of pro-inflammatory or anti-inflammatory stimulators or mediators. The devices, systems, and methods serve to prevent, control, reduce, or alleviate the severity of the inflammatory response and disease states that are associated with abnormal levels of or unregulated or excessive interaction among pro-inflammatory or anti-inflammatory stimulators or mediators.

We claim:  
     
         1 . A blood processing system comprising a blood component product harvested from the blood drawn from an individual, a container sized to receive the blood component product, and a device communicating with the container to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators from the blood component product.  
     
     
         2 . A system according to  claim 1   wherein the blood component product includes a red blood cell component.    
     
     
         3 . A system according to  claim 1   wherein the blood component product includes a platelet component.    
     
     
         4 . A system according to  claim 1   wherein the blood component product includes a white blood cell component.    
     
     
         5 . A system according to  claim 1   wherein the blood component product includes a plasma component.    
     
     
         6 . A system according to  claim 1   wherein the device includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators.    
     
     
         7 . A system according to  claim 6   wherein the adsorption medium is characterized by a Biocompatibility Index of not greater than 14.    
     
     
         8 . A system according to  claim 7   wherein the Biocompatibility Index is not greater than 7.    
     
     
         9 . A system according to  claim 1  or  2  
 wherein the device includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators, the adsorption medium comprising a polymeric material.  
 
     
     
         10 . A system according to  claim 9   wherein the polymeric material comprises particles prepared by polymerization or copolymerization of a monomer selected from a group consisting of styrene, ethylstyrene, α-methylstyrene, divinylbenzene, di isopropenyl benzene, trivinylbenzene, and alkyl methacrylate.    
     
     
         11 . A system according to  claim 9   wherein the polymeric material comprises particles formed from crosslinked polystyrene-type resins having a surface modified to minimize activation of blood complement system.    
     
     
         12 . A system according to  claim 9   wherein the polymeric material comprises particles formed from a porous hydrophobic divinylbenzene copolymer having a surface modified to include surface exposed functional groups selected from the group of polymers of 2-hydroxyethyl methacrylate, N-vinylpyrrolidine, N-vinylcaprolactame and N-acrylamide.    
     
     
         13 . A system according to  claim 9   wherein the polymeric material comprises particles formed by polymerization of aromatic divinyl compounds or their copolymerization with aromatic monovinyl compounds in the presence of porogens or mixtures of porogens with properties close to those of θ-solvents.    
     
     
         14 . A system for collecting a blood component product comprising 
 means for processing the blood drawn from an individual into a blood component product,    a storage container,    means for collecting the blood component product in the storage container, and    means for removing cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators from the blood component product before, during, or after its collection in the storage container.    
     
     
         15 . A system according to  claim 14   wherein the blood component product includes a red blood cell component.    
     
     
         16 . A system according to  claim 14   wherein the blood component product includes a platelet component.    
     
     
         17 . A system according to  claim 14   wherein the blood component product includes a white blood cell component.    
     
     
         18 . A system according to  claim 14   wherein the blood component product includes a plasma component.    
     
     
         19 . A system according to  claim 14   wherein the means for removing cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators.    
     
     
         20 . A system according to  claim 19   wherein the adsorption medium is characterized by a Biocompatibility Index of not greater than 14.    
     
     
         21 . A system according to  claim 20   wherein the Biocompatibility Index is not greater than 7.    
     
     
         22 . A system according to  claim 14   wherein the device includes an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators, the adsorption medium comprising a polymeric material.    
     
     
         23 . A system according to  claim 22   wherein the polymeric material comprises particles prepared by polymerization or copolymerization of a monomer selected from a group consisting of styrene, ethylstyrene, α-methylstyrene, divinylbenzene, di isopropenyl benzene, trivinylbenzene, and alkyl methacrylate.    
     
     
         24 . A system according to  claim 22   wherein the polymeric material comprises particles formed from crosslinked polystyrene-type resins having a surface modified to minimize activation of blood complement system.    
     
     
         25 . A system according to  claim 22   wherein the polymeric material comprises particles formed from a porous hydrophobic divinylbenzene copolymer having a surface modified to include surface exposed functional groups selected from the group of polymers of 2-hydroxyethyl methacrylate, N-vinylpyrrolidine, N-vinylcaprolactame and N-acrylamide.    
     
     
         26 . A system according to  claim 22   wherein the polymeric material comprises particles formed by polymerization of aromatic divinyl compounds or their copolymerization with aromatic monovinyl compounds in the presence of porogens or mixtures of porogens with properties close to those of e-solvents.    
     
     
         27 . A method for collecting a blood component product comprising the steps of 
 processing the blood drawn from an individual into a blood component product,    collecting the blood component product in a storage container, and    removing cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators from the blood component product before, during, or after its collection in the storage container.    
     
     
         28 . A method according to  claim 27   wherein the blood component product includes a red blood cell component.    
     
     
         29 . A method according to  claim 27   wherein the blood component product includes a platelet component.    
     
     
         30 . A method according to  claim 27   wherein the blood component product includes a white blood cell component.    
     
     
         31 . A method according to  claim 27   wherein the blood component product includes a plasma component.    
     
     
         32 . A method according to  claim 27   wherein the removing step includes use of an adsorption medium to remove cytokines or other species of pro-inflammatory or anti-inflammatory stimulators or mediators.    
     
     
         33 . A method according to  claim 32   wherein the adsorption medium comprises a polymeric material.    
     
     
         34 . A method according to  claim 33   wherein the polymeric material comprises particles prepared by polymerization or copolymerization of a monomer selected from a group consisting of styrene, ethylstyrene, α-methylstyrene, divinylbenzene, di isopropenyl benzene, trivinylbenzene, and alkyl methacrylate.    
     
     
         35 . A method according to  claim 33   wherein the polymeric material comprises particles formed from crosslinked polystyrene-type resins having a surface modified to minimize activation of blood complement system.    
     
     
         36 . A method according to  claim 33   wherein the polymeric material comprises particles formed from a porous hydrophobic divinylbenzene copolymer having a surface modified to include surface exposed functional groups selected from the group of polymers of 2-hydroxyethyl methacrylate, N-vinylpyrrolidine, N-vinylcaprolactame and N-acrylamide.    
     
     
         37 . A method according to  claim 33   wherein the polymeric material comprises particles formed by polymerization of aromatic divinyl compounds or their copolymerization with aromatic monovinyl compounds in the presence of porogens or mixtures of porogens with properties close to those of θ-solvents.