Sterile, pyrogen-free, polymeric film-based heating bag

Abstract

In one embodiment, there is a method for storing fluids in a bag that has an inner lining that is essentially sterilized and essentially free of pyrogen. The method comprises heating the bag that is comprised of a polymeric film to at least approximately 253° Celsius. The polymeric film includes a polymer selected from the group of poly(oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene) (PEEK); polytetrafluoroethylene (PTFE); a perfluoroalkoxy (PFA) polymer; poly(tetrafluoroethylene-co-perfluoromethyl vinyl ether) (MFA); polyperfluoro(ethylene-co-propylene) (FEP); poly(ethylene-alt-chlorotrifluoroethylene) (ECTFE); poly(ethylene-co-tetrafluoroethylene) (ETFE); poly(vinylidene fluoride) (PDVF); tetrafluoroethylene-co-hexafluoropropylene-co-vinylidene fluoride terpolymer (THV); ultra-high molecular weight polyethylene (UHMW PE); (poly(bisphenol A-co-4-nitrophthalic anhydride-co-1,3-phenylenediamine) (PEI); poly(4-methyl-1-pentene) (PMP); and suitable mixtures thereof.

1 - 13 . (Canceled)  
     
     
         14 . An apparatus comprising: 
 a bag for the storage of fluids, the bag comprised of a polymeric film comprising a polymer selected from the group of poly(oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene) (PEEK); polytetrafluoroethylene (PTFE); a perfluoroalkoxy (PFA) polymer; poly(tetrafluoroethylene-co-perfluoromethyl vinyl ether) (MFA); polyperfluoro(ethylene-co-propylene)(FEP); poly(ethylene-alt-chlorotrifluoroethylene) (ECTFE); poly(ethylene-co-tetrafluoroethylene) (ETFE); poly(vinylidene fluoride) (PDVF); tetrafluoroethylene-co-hexafluoropropylene-co-vinylidene fluoride terpolymer (THV); ultra-high molecular weight polyethylene (UHMW PE); (poly(bisphenol A-co-4-nitrophthalic anhydride-co-1,3-phenylenediamine) (PEI); poly(4-methyl-1-pentene) (PMP); and suitable mixtures thereof, the bag suitable for heating to at least approximately 253° Celsius.    
     
     
         15 . The apparatus of  claim 14 , wherein the thickness of the polymeric film is in a range of approximately 15 to 50 microns.  
     
     
         16 . The apparatus of  claim 14 , wherein the bag is suitable for heating to at least 253° Celsius for at least approximately 30 minutes.  
     
     
         17 . The apparatus of  claim 14 , wherein the bag is suitable for heating to at least 253° Celsius for at least approximately 60 minutes.  
     
     
         18 . The apparatus of  claim 14 , wherein the fluids comprise bodily fluids.  
     
     
         19 . The apparatus of  claim 14 , wherein the fluids comprise blood.  
     
     
         20 - 22 . (Canceled)  
     
     
         23 . A kit comprising: 
 a bag for the storage of fluids, the bag comprised of a polymeric film comprising a polymer selected from the group of poly(oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene) (PEEK); polytetrafluoroethylene (PTFE); a perfluoroalkoxy (PFA) polymer; poly(tetrafluoroethylene-co-perfluoromethyl vinyl ether) (MFA); polyperfluoro(ethylene-co-propylene)(FEP); poly(ethylene-alt-chlorotrifluoroethylene) (ECTFE); poly(ethylene-co-tetrafluoroethylene) (ETFE); poly(vinylidene fluoride) (PDVF); tetrafluoroethylene-co-hexafluoropropylene-co-vinylidene fluoride terpolymer (THV); ultra-high molecular weight polyethylene (UHMW PE); (poly(bisphenol A-co-4-nitrophthalic anhydride-co-1,3-phenylenediamine) (PEI); poly(4-methyl-1-pentene) (PMP); and suitable mixtures thereof, the bag suitable for heating to at least approximately 253° Celsius; packaging material; and    instructions or indica located on the packaging material or inside the packaging material.    
     
     
         24 . The kit of  claim 23 , further comprising fluids stored in the bag.  
     
     
         25 . The kit of  claim 24 , wherein the bag is not heated to at least approximately 253° Celsius after the fluids are stored in the bag.  
     
     
         26 . The kit of  claim 23 , wherein a thickness of the polymeric film is in a range of approximately 15 to 50 microns.  
     
     
         27 . The kit of  claim 23 , wherein the bag is suitable for heating to at least 253° Celsius for at least approximately 30 minutes.  
     
     
         28 . The kit of  claim 23 , wherein the bag is suitable for heating to at least 253° Celsius for at least approximately 60 minutes.  
     
     
         29 . The apparatus of  claim 14 , wherein the bag comprises: 
 a first film comprised of a polymer selected from a material group consisting of poly(oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene) (PEEK); polytetrafluoroethylene (PTFE); a perfluoroalkoxy (PFA) polymer; poly(tetrafluoroethylene-co-perfluoromethyl vinyl ether) (MFA); polyperfluoro(ethylene-co-propylene)(FEP); poly(ethylene-alt-chlorotrifluoroethylene) (ECTFE); poly(ethylene-co-tetrafluoroethylene) (ETFE); poly(vinylidene fluoride) (PDVF); tetrafluoroethylene-co-hexafluoropropylene-co-vinylidene fluoride terpolymer (THV); ultra-high molecular weight polyethylene (UHMW PE); (poly(bisphenol A-co-4-nitrophthalic anhydride-co-1,3-phenylenediamine) (PEI); poly(4-methyl-1-pentene) (PMP); and    a second film that is coupled to the first film and comprised of a polymer selected from the material group.    
     
     
         30 . The apparatus of  claim 29 , and further comprising: 
 a connector comprised of a polymer and positioned approximately perpendicular to an edge of the first film.    
     
     
         31 . The apparatus of  claim 29 , wherein the second film is coupled to the first film by welding edges of the first film to edges of the second film.  
     
     
         32 . The apparatus of  claim 31 , wherein edges of the first film are welded to edges of the second film by heating the edges of the first film and edges of the second film to at least approximately 330° Celsius.  
     
     
         33 . The apparatus of  claim 29 , wherein the second film is coupled to the first film by ultrasonic sealing the edges of the first film to the edges of the second film.  
     
     
         34 . The kit of  claim 23 , wherein the bag comprises: 
 a first film comprised of a polymer selected from a material group consisting of poly(oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene) (PEEK); polytetrafluoroethylene (PTFE); a perfluoroalkoxy (PFA) polymer; poly(tetrafluoroethylene-co-perfluoromethyl vinyl ether) (MFA); polyperfluoro(ethylene-co-propylene)(FEP); poly(ethylene-alt-chlorotrifluoroethylene) (ECTFE); poly(ethylene-co-tetrafluoroethylene) (ETFE); poly(vinylidene fluoride) (PDVF); tetrafluoroethylene-co-hexafluoropropylene-co-vinylidene fluoride terpolymer (THV); ultra-high molecular weight polyethylene (UHMW PE); (poly(bisphenol A-co-4-nitrophthalic anhydride-co-1,3-phenylenediamine) (PEI); poly(4-methyl-1-pentene) (PMP); and    a second film that is coupled to the first film and comprised of a polymer selected from the material group.    
     
     
         35 . The kit of  claim 34 , and further comprising: 
 a connector comprised of a polymer and positioned approximately perpendicular to an edge of the first film.    
     
     
         36 . The kit of  claim 34 , wherein the second film is coupled to the first film by welding edges of the first film to edges of the second film.  
     
     
         37 . The kit of  claim 36 , wherein edges of the first film are welded to edges of the second film by heating the edges of the first film and edges of the second film to at least approximately 330° Celsius.  
     
     
         38 . The kit of  claim 34 , wherein the second film is coupled to the first film by ultrasonic sealing the edges of the first film to the edges of the second film.