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.

Description

TECHNICAL FIELD This invention generally relates a heating bag. More particular, the invention relates to an essentially sterile, pyrogen-free, polymeric film-based heating bag. The polymeric film can include 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. BACKGROUND The storage of fluids and liquids that are essentially free of contaminants and ba...

AI Technical Summary

Benefits of technology

Systems, apparatuses and methods for an essentially sterile, pyrogen-free, polymeric film-based heating bag are now described. Embodiments of the invention can be used as infusion solutions, blood bags, mixing bags or any other type of bag which stores liquids, solids or gases. In an embodiment, these polymeric film-based bags are heated to a predetermined temperature and maintained as such temperature for a predetermined time. In one embodiment, the predetermined temperature is at least approximately 253° Celsius. In an embodiment, the predetermined time is at least one hour. Heating of the bag at such temperature for this time period satisfies current FDA standards to ensure that the bags are essentially sterile and free of pyrogen. Subsequently, fluids, such as blood, may be stored in the bags. Accordingly, embodiments of the invention are relatively less expensive in comparison to current approaches that use glass containers. Moreover, such bags do not trap air therein along with the fluids, as may occur when glass containers are used (as described above). Therefore, when such bags are used for a blood transfusion, relatively expensive electronic monitoring is not needed to ensure that air is not passed along with the transfusion of the blood into the individual receiving the transfusion.

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.

In an embodiment, there is a method for forming a polymeric film-based bag for storage of liquid. The method comprises aligning edges of a first polymeric film with edges of a second polymeric film. The method also includes placing a connector approximately perpendicular with one edge of the edges of the first polymeric film and one edge of the second polymeric film. The method includes coupling the edges of the first polymeric film to the edges of the second polymeric film. The first and second polymeric films are each independently 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-vi

Problems solved by technology

Therefore, when such bags are used for a blood transfusion, relatively expensive electronic monitoring is not needed to ensure that air is not passed along with the transfusion of the blood into the individual receiving the transfusion.

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