Title of Invention	"MEDICAL GAS BARRIER FILM AND MEDICAL BAG USING THE SAME"
Abstract	on one surface, an oriented polyamide layer 15 adhered to the surface of the deposited layer 13 and a polyethylene layer 17 adhered to the surface on the opposite side to an adhered surface 15a of the oriented polyamide layer 15, and a multilayer substrate film 22 including a cyclic olefin polymer layer 25, an elastomer layers 24, 26 and a heat sealing layer 23, and the multilayer substrate film 22 is adhered to an other surface l1b on the opposite side of the deposited layer of the deposition oriented polyester layer 11.

Title of Invention

"MEDICAL GAS BARRIER FILM AND MEDICAL BAG USING THE SAME"

Abstract

on one surface, an oriented polyamide layer 15 adhered to the surface of the deposited layer 13 and a polyethylene layer 17 adhered to the surface on the opposite side to an adhered surface 15a of the oriented polyamide layer 15, and a multilayer substrate film 22 including a cyclic olefin polymer layer 25, an elastomer layers 24, 26 and a heat sealing layer 23, and the multilayer substrate film 22 is adhered to an other surface l1b on the opposite side of the deposited layer of the deposition oriented polyester layer 11.

Full Text	Description MEDICAL GAS BARRIER FILM AND MEDICAL BAG USING THE SAME Technical Field The present invention relates to a gas barrier film suitable for medical applications and capable of maintaining excellent gas and vapor barrier properties and restricting elution of compounding ingredients of the film and ingredients of an adhesive without impairing flexibility, transparency and impact resistance of the film even after heating and sterilizing treatment and long storage, and a medical bag using the gas barrier film. Background Art Plastic bags such as infusion solution bags have advantages of easy handling and simple disposal after use. Currently, polyethylene as a safe material is generally used for plastic bags prevailing in the field of medical containers. However, since polyethylene is a plastic having high gas permeability, when easily oxidized medicine such as amino acid is contained in a medical bag, the medical bag is generally held in a plastic outer bag having gas barrier property together with an oxygen absorber. On the other hand, to reduce costs of the outer bag, there has been a demand to impart gas barrier property to the medical bag itself and various plastic materials having gas barrier property as well as properties including flexibility, transparency and impact resistance have been considered. A plastic material described in Patent document 1 is characterized in that it is a multilayer film having a heat sealing resin layer, a biaxial oriented polyester resin film with an inorganic oxide deposited layer, a biaxial oriented polyamide resin film and a surface protective film, wherein the deposited layer of the biaxial oriented polyester resin film is adhered to the heat sealing resin layer, the surface on the opposite side to the deposited surface of the biaxial oriented polyester resin film is adhered to one surface of the biaxial oriented polyamide resin film, and the surface protective film is disposed on the other surface of the biaxial oriented polyamide resin film. A plastic material described in Patent document 2 is characterized in that it is a multilayer film having a polyethylene layer forming a heat sealing part, a cyclic olefin polymer layer and a polyethylene terephthalate layer with an inorganic oxide deposited layer, wherein the polyethylene layer is adhered to one surface of the cyclic olefin polymer layer and the deposited layer of the polyethylene terephthalate layer is adhered to the other surface of the cyclic olefin polymer layer. A plastic material described in Patent document 3 is characterized in that it is a multilayer film having a heat sealing layer (ethylene polymer), a biaxial oriented film (biaxial oriented polyethylene) substrate with an inorganic oxide deposited layer and a protective film (biaxial oriented polyamide film), wherein the heat sealing layer is adhered to the surface on the opposite side to the inorganic oxide deposited layer of the biaxial oriented film substrate, and the protective film is adhered to the surface of the inorganic oxide deposited layer of the biaxial oriented film substrate. [Patent document 1] Japanese Unexamined Patent Publication No. 2004-58336 [Patent document 2] Japanese Unexamined Patent Publication No. 2001-157705 [Patent document 3] Japanese Unexamined Patent Publication No. 2004-148681 Disclosure of the Invention Problems to be Solved by the Invention Medical bags require, for example, heat resistance to heating and sterilizing treatment and safety to drugs contained therein (especially, low elution behavior of compounding ingredients of a resin film and ingredients of an adhesive) in addition to properties such as flexibility, transparency and impact resistance, which are required for conventional plastic bags. However, in the present circumstances, a plastic material which fulfills all of the properties has not been found. The multilayer films disclosed in Patent documents 1 to 3 have a common problem that flexibility is low and thus creases and lines are easy to generate when an infusion solution bag or the like is formed of the films. Further, the multilayer films described in Patent documents 1 and 2 have the problem that gas and vapor barrier properties are easy to lower over time since the deposited layer of the polyester (polyethylene terephtalate) film substrate is disposed at the side of an inner surface of a packaging body using the multilayer films. The multilayer films described in Patent documents 1 and 3 have the problem that the adhesive used for adhesion between the layers is eluted. In the multilayer films described in Patent documents 2 and 3, since the thickness between an outer surface of a packaging body using the multilayer films and the deposited layer is small, gas and vapor properties can lower over time. An object of the present invention is to provide a gas barrier film suitable for medical applications capable of realizing excellent gas and vapor barrier properties while maintaining flexibility, transparency and impact resistance of the film and controlling elution of compounding ingredients of the film and ingredients of an adhesive even after heating and sterilizing treatment and long storage, and a medical bag using the gas barrier film. Means for Solving Problems To solve the above-mentioned problems, the present invention provides (1) a medical gas barrier film comprising a multilayer gas barrier film and a multilayer substrate film adhered to the multilayer gas barrier film, wherein the multilayer gas barrier film includes a deposition oriented polyester layer having a deposited layer of an inorganic oxide on one surface, an oriented polyamide layer adhered to the surface of the deposited layer of the deposition oriented polyester layer and a polyethylene layer adhered to the surface on the opposite side to the adhered surface of the oriented polyamide layer to the deposited layer, the multilayer substrate film includes a cyclic olefin polymer layer, an elastomer layer and a heat sealing layer and is adhered to the other surface of the deposition oriented polyester layer, and the heat sealing layer is disposed on the surface on the opposite side to the adhered surface of the multilayer substrate film to the deposition oriented polyester layer, (2) a medical gas barrier film as stated in the above (1), wherein the multilayer substrate film has a cyclic olefin polymer layer, a first elastomer layer adhered to one surface of the cyclic olefin polymer layer, a heat sealing layer on the opposite side to the adhered surface of the first elastomer layer to the cyclic olefin polymer layer, a second elastomer layer adhered to the other surface of the cyclic olefin polymer layer and a polyethylene layer adhered to the surface on the opposite side to the adhered surface of the second elastomer layer to the cyclic olefin polymer layer, (3) a medical gas barrier film as stated in the above (2), wherein the total thickness of the first elastomer layer and the second elastomer layer is 55 to 80 % of the thickness of the multilayer substrate film, (4) a medical gas barrier film as stated in the above (1), wherein the thickness of the polyethylene layer of the multilayer gas barrier film is 1 or 2 times larger than the total thickness of the deposition oriented polyester layer and the oriented polyamide layer, (5) a medical gas barrier film as stated in the above (1) , wherein the polyethylene layer of the multilayer gas barrier film is a three-layer film formed of a linear polyethylene film having a density of 0.910 to 0.930 g/cm3 and high density polyethylene films each having a density of 0.950 to 0.970 g/cm3 and adhered to both surfaces of the linear polyethylene layer, and the thickness of each high density polyethylene film is 0.2 to 0.3 time larger than that of the linear polyethylene film, (6) a medical gas barrier film as stated in the above (I), wherein the inorganic oxide is alumina, (7) a medical gas barrier film as stated in the above (I), wherein the multilayer substrate film is a cylindrical film formed by inflation molding and an innermost layer of the cylindrical film is the heat sealing layer, (8) a medical bag formed by welding a medical gas barrier film so that heat sealing layers thereof face each other, wherein the medical gas barrier film comprises a multilayer gas barrier film and a multilayer substrate film adhered to the multilayer gas barrier film, the multilayer gas barrier film includes a deposition oriented polyester layer having a deposited layer of an inorganic oxide on one surface, an oriented polyamide layer adhered to the surface of the deposited layer of the deposition oriented polyester layer and a polyethylene layer adhered to the surface on the opposite side to the adhered surface of the oriented polyamide layer to the deposited layer, the multilayer substrate film includes a cyclic olefin polymer layer, an elastomer layer and a heat sealing layer and is adhered to the other surface of the deposition oriented polyester layer, and the heat sealing layer is disposed on the surface on the opposite side to the adhered surface of the multilayer substrate film to the deposition oriented polyester layer, (9) a medical bag formed by welding an open end of a multilayer substrate film in a medical gas barrier film, wherein the medical gas barrier film comprises a multilayer gas barrier film and a multilayer substrate film adhered to the multilayer gas barrier film, the multilayer gas barrier film includes a deposition oriented polyester layer having a deposited layer of an inorganic oxide on one surface, an oriented polyamide layer adhered to the surface of the deposited layer of the deposition oriented polyester layer and a polyethylene layer adhered to the surface on the opposite side to the adhered surface of the oriented polyamide layer to the deposited layer, the multilayer substrate film is a cylindrical film formed by inflation molding, includes a cyclic olefin polymer layer, an elastomer layer and a heat sealing layer and is adhered to the other surface of the deposition oriented polyester layer, the heat sealing layer is disposed on the surface on the opposite side to the adhered surface of the multilayer substrate film to the deposition oriented polyester layer, and an innermost layer of the cylindrical multilayer substrate film is the heat sealing layer, (10) a medical bag as stated in the above ( 8 ) , the whole of which is subjected to heating and sterilization after being filled with a medical fluid and sealed, and (11) a medical bag as stated in the above ( 9 ) , the whole of which is subjected to heating and sterilization after being filled with a medical fluid and sealed. Effects of the Invention A gas barrier film according to the present invention can obtain excellent gas and vapor barrier properties while maintaining flexibility, transparency and impact resistance of the film, and suppress degradation of gas and vapor barrier properties with time due to heating and sterilizing treatment and long storage as well as elution of compounding ingredients of the f i lm and ingredients of an adhesive. Brief Description of the Drawings Fig. 1 is a schematic sectional view showing the configuration of layers of a medical gas barrier film in accordance with an embodiment. Fig. 2 is a front view showing a medical bag in accordance with an embodiment. Fig. 3 is a front view showing a medical bag in accordance with another embodiment. Description of Reference Numerals 10 Multilayer gas barrier film 11 Deposition oriented polyester layer 15 Oriented polyamide layer 17 Polyethylene layer 22 Multilayer substrate film 23 Heat sealing layer 24 First elastomer layer 25 Cyclic olefin polymer layer 26 Second elastomer layer 30 Medical bag Best Mode for Carrying out the Invention A medical gas barrier film of the present invention comprises (i) a multilayer gas barrier film including an deposition oriented polyester layer having an inorganic oxide deposited layer on one surface thereof, an oriented polyamide layer adhered to the surface of the deposited layer and a polyethylene layer adhered to the surface on the opposite side to the adhered surface of the oriented polyamide layer to the deposited layer, and (ii) a multilayer substrate film including a cyclic olefin polymer layer, an elastomer layer and a heat sealing layer, and the above (ii) multilayer substrate film is adhered to the other surface of the deposition oriented polyester layer in the above (i) multilayer gas barrier film, and the heat sealing layer in the above (ii) multilayer substrate film is disposed on the surface on the opposite side to the surface adhered to the deposition oriented polyester layer. As described above, the multilayer gas barrier film includes three layers of the layer formed of the deposition oriented polyester film having the inorganic oxide deposited layer on one surface thereof (hereinafter, referred to as "deposition oriented polyester layer") , the oriented polyamide layer adhered to the surface of the deposited layer of the deposition oriented polyester layer and the polyethylene layer adhered to the surface on the opposite side to the adhered surface of the oriented polyamide layer to the deposited layer. The deposition oriented polyester layer is, for example, a layer formed to impart gas barrier property to the whole medical gas barrier film and is made by forming the inorganic oxide deposited layer on the surface of the polyester film subjected to orienting treatment. Polyesters for the oriented polyester film include polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene napthalate (PEN) and polybutylene napthalate (PBN). Orienting treatment of the polyester film may be either uniaxial orientation or biaxial orientation. Specific techniques of biaxial orienting treatment include tubular biaxial orientation and tenter biaxial orientation. By applying orienting treatment to the polyester film, pinhole resistance, strength, heat resistance in evaporating treatment, surface smoothness of the film and the like can be improved. Inorganic oxides forming the deposited layer include alumina (aluminum oxide), silica (silicon oxide), magnesium oxide and titan oxide, for example. Especially, alumina is preferable in terms of transparency of the deposited layer. Specific examples of the deposition oriented polyester film having the deposited layer made of alumina (hereinafter, referred to as "alumina deposition oriented polyester film") include transparent barrier films manufactured by Toppan Printing Co., Ltd. (product name "GL FAMILY"; "GL-AEH" (substrate: PET), "GL-AU" (substrate: PET), "GL-AE" (substrate: PET)) and transparent barrier films manufactured by Toray Advanced Film Co., Ltd. (product name "BARRIER ROCKS" series; "1011RG", "1011HG","1031HG", and so on). The ratio of the deposition oriented polyester layer to the multilayer gas barrier film in thickness is preferably 15 to 35 %, more preferably 10 to 30 %, and the ratio of the deposition oriented polyester layer to the entire medical gas barrier film in thickness is preferably 3 to 10 %, more preferably 5 to 7 % . The thickness of the deposition oriented polyester layer is preferably 7 to 20 urn, more preferably 9 to 15 μm. The oriented polyamide layer is, for example, a layer formed to protect the deposited layer of the deposition oriented polyester layer and is made using a polyamide film subjected to orienting treatment. Polyamides for the oriented polyamide film include nylon-6, nylon-6,6, nylon-6,10, nylon-6,12, nylon-11 and nylon-12. Orienting treatment of the polyamide film may be either uniaxial orientation or biaxial orientation. Specific techniques of biaxial orienting treatment include tubular biaxial orientation and tenter biaxial orientation, for example. By applying orienting treatment to the polyamide film, pinhole resistance, strength, heat resistance in evaporating treatment, surface smoothness of the film and the like can be improved. Specific examples of the oriented polyamide film include biaxial oriented nylon films manufactured by Unitica Ltd. (product name "EMBLEM (registered trademark) series; "EMBLEM ONMB", and so on). The ratio of the oriented polyamide layer to the multilayer gas barrier film in thickness is preferably 15 to 35 %, more preferably 20 to 30 %, and the ratio of the oriented polyamide layer to the entire medical gas barrier film in thickness is preferably 3 to 10 %, more preferably 5 to 10 %. The thickness of the oriented polyamide layer is preferably 7 to 20 um, more preferably 10 to 15 um. The polyethylene layer in the multilayer gas barrier film is an outermost layer of a medical bag in the case where the medical bag is formed using the medical gas barrier film of the present invention, and for example, a layer formed to protect the surface of the medical gas barrier film and add soft touch to the medical gas barrier film. The polyethylene film forming the polyethylene layer is not limited by density range such as high density and low density, molecular structure such as straight chain, and manufacturing methods such as high-pressure process and low-pressure process, and various polyethylene films may be used. The polyethylene film may be formed of one type of polyethylene or a composite of two or more types of polyethylene. Further, the polyethylene film may be a multilayer film formed of two or more types of polyethylene . Specific examples of the multilayer film include a three-layer film in which high density polyethylene having a density of 0.950 to 0.970 g/cm3 is disposed on both surfaces of a linear polyethylene film having a density of 0.910 to 0.930 g/cm3. When the above-mentioned three-layer film is used as the polyethylene film forming the polyethylene layer, properties such as formability and strength of the medical gas barrier film of the present invention can be further improved. The ratio of the high density polyethylene in the three-layer film to the linear polyethylene in thickness is preferably 0.2 to 0.3, more preferably 0.22 to 0.28. The thickness of the polyethylene layer is preferably 1 to 2 times, more preferably 1.2 to 1.8 times, larger than that of the sum of the alumina deposition oriented polyester layer and the oriented poly amide layer . The thickness of the polyethylene layer is preferably 5 to 30 urn. The multilayer gas barrier film can be manufactured by separately molding three types of films of the alumina deposition oriented polyester layer, the oriented polyamide layer and the polyethylene layer and then laminating the films according to various laminating methods. Various laminating methods can be adopted and a dry laminating method wherein an adhesive is used is the most preferable among them. Although the thickness of the entire multilayer gas barrier film is not specifically limited, the thickness of 30 to 80 um is preferable. Various adhesives used for manufacture of the laminated film can be adopted as an adhesive used in the dry laminating method. The adhesives include "TAKELAC" series (product name "TAKELAC A315", etc.) and "TAKENATE" series (product name) manufactured by Mitsui Takeda Chemicals Co., Ltd. The less the amount of ingredients of the adhesive eluted from the multilayer gas barrier film is, the better the adhesive is. Such adhesives include adhesives for dry lamination comprising at least a base compound and a stiffener, and the following combinations of the base compound and the stiffener are included (Refer to Japanese Unexamined Patent Publication No. 2000-309770, Japanese Unexamined Patent Publication No. 2000-351953 and Japanese Unexamined Patent Publication No. 2002-155260) . Base compound: polyether-polyurethane resin formed by extending a resin consisting of polyether and glycols and/or amines with diisocyanates; polyester resin formed of at least one type of acids selected from the group consisting of aromatic carboxylic acid, alicyclic carboxylic acid, aliphatic carboxylic acid and unsaturated carboxylic acid, esters or lactones of the above carboxylic acid and at least one type of glycols; polyester-urethane-diol resin formed by extending the above-mentioned polyester resin with diisocyanates; polyester resin formed of at least one type selected from the group consisting of dimer fatty acids and their esters and at least one type of glycols (at least one type of grycols selected from the group consisting of aromatic dicarboxylic acids and their ester compounds); polyester-urethane-diol resin formed by extending the polyester resin with diisocyanates; polyester-urethane-diol resin formed by extending the polyester diol resin formed of at least one type selected from the group consisting of dimer fatty acids, hydrogenated dimer fatty acids and ester and at least one type of glycols with diisocyanates. Stiffener: isocyanates adduct of trimethylolpropane, buret or trimer of diisocyanates. The multilayer gas barrier film can be manufactured by adopting an extrusion laminating method in place of the dry laminating method. In this case, an adhesive resin may be used in place of the above-mentioned adhesive and molding conditions of the publicly known extrusion laminating method can be employed. Adhesive resins preferably include, for example, nodified polyolefin obtained by graft copolymerizing polyolefin such as polyethylene with unsaturated carboxylic acid such as maleic acid, fumaric acid, tetrahydrophthalic adid, itaconic acid, citraconic acid, crotonic acid, isocrotonic acid, nagic acid, acrylic acid and methacryl acid or anhydrides of these acids. As described above, the multilayer substrate film is provided on the other surface (the surface on the opposite side of the surface on which the deposited layer is formed) of the deposition oriented polyester layer in the multilayer gas barrier film, and is a laminated body having the cyclic olefin polymer layer, the elastomer layer and the heat sealing layer. The cyclic olefin polymer layer is provided to prevent ingredients of the adhesive from exuding from the multilayer gas barrier film and permeation of moisture from exerting a negative impact such as peeling on the deposited layer of the deposition oriented polyester film, for example. Cyclic olefin polymers forming the cyclic olefin polymer layer include, for example, a copolymer of ethylene and dicyclopentadiene compound, a copolymer of ethylene and norbornene compound, a ring-opened polymer of cyclopentadiene compound, a ring-opened copolymer of two or more types of cyclopentadiene compound and their hydrogenated polymers and copolymers. In particular, the hydrogenated polymers and copolymers as saturated polymers among the above-mentioned cyclic olefin polymers are suitable for the material for the cyclic olefin polymer layer of the present invention since they are especially excellent in vapor barrier property and gas barrier property and also excellent in the effect of preventing absorption/adsorption of medicine, heat resistance, transparency, stability and the like. The hydrogenated copclymer of ethylene and norbornene compound and the hydrogenated ring-opened polymer (copolymer) of one or two or more types of cyclopentadiene derivative are especially preferable among the above-mentioned cyclic olefin polymers. Specific examples of the cyclic olefin polymers include a polymer having repeating unit shown in the following general formula (1) and repeating unit shown in the following general formula (!') and a polymer having repeating unit shown in the following general formula (2) . (Figure Removed) (In the formulas, R1, R:', R2, R2', R3 and R4 independently indicate hydrogen atom, hydrocarbon residue, halogen atom, ester, and a polar group such as nitryl and pylidyl. R1 and R2, R1 and R2' and R" and R4 may be connected to each other to form a ring, m, m' x and z indicate an integer of 1 or more, and n, n' and y indicates an integer of 1 or more). The polymer having the repeating units shown in the general formulas (1) and (1') is obtained by polymerizing one or two or more types of norbornene monomers according to a publicly known ring-opened polymerizing method or hydrogenating the ring-opened polymer thus obtained according to an ordinary method. On the other hand, the polymer having a structural unit shown in the general formula (2) is obtained by additive-copolymerizing one or two or more types of norbornene monomers and ethylene according to a publicly known method or hydrogenating the copolymer thus obtained according to an ordinary method. Although the type of cyclic olefin polymer is not specifically limited, the glass transition temperature (Tg) thereof is preferably 70°C or higher, more preferably 80 to 150'C. Although the molecular weight of cyclic olefin polymer is not specifically limited, the number molecular weight measured according to gel permeation chromatography (GPC) analysis using cyclohexane as a solvent is preferably 10 to 100 thousand, more preferably 20 to 50 thousand. In the case where unsaturated bonding remaining in the molecular chain of cyclic olefin polymer is saturated by hydrogenation, although the hydrogenation ratio is not specifically limited, it is preferably 90 % or more, more preferably 95 % or more, even more preferably 99 % or more. Specific examples of the cyclic olefin polymers include cyclic olefin polymer manufactured by Mitsui Chemicals, Inc. (product name "APEL (registered trademark)" series), optical resin manufactured by JSR Corporation ("ARTON (registered trademark)"), general-purpose transparent engineering plastics manufactured by Zeon Corp., (product name "ZEONOR (registered trademark)" series) and "TOPAS (product name)" manufactured by Ticona GmbH. In terms of compatibility with a layer adjacent to the cyclic olefin polymer layer (for example, an elastomer layer described later) , mixed resin of cyclic olefin polymer and polyolefin resin may be used for the cyclic olefin polymer layer. The polyolefin resins include, for example, polyethylene (PE) homopolymer, copolymer of ethylene and a-olefins having a carbon number 3 to 12 (for example, butane-1, pentene-1, hexene-1, 4-methyl-l-pentene, cctene-1, decene-1), polypropylene (PP) homopolymer, and copolymer of propylene and a-olefins having a carbon number 2 to 12 (for example, ethylene, butane-1, pentene-1, hexene-1, 4-methyl-l-pentene, octene-1, decene-1). Above all, PE homopolymer is preferable . An example of a preferred mode of mixed resin of cyclic olefin polymer and polyolefin resin is that polyethylene having a density of 0.910 to 0.930 g/cm3 is mixed to cyclic olefin polymer by 5 to 40 weight %. The ratio of the cyclic olefin polymer layer to the multilayer substrate film in thickness is preferably 3 to 10 % and the ratio of the cyclic olefin polymer to the entire medical gas barrier film in thickness is 5 to 10 %. The thickness of the cyclic olefin polymer layer is preferably 10 to 20 μm. To protect hard and fragile cyclic olefin polymer, the elastomer layer is provided on the surface on each of both sides of the cyclic olefin polymer layer. Elastomers for the elastomer layer include polyolefin elastomers, styrene elastomers and urethane elastomers, for example. Polyolefin elastomers include linear polyethylene elastomer, ethylene-a-olefin copolymer elastomer and propylene-a-olefin copolymer elastomer, for example. The a-olefins include a-olefins having a carbon number of 3 to 6 such as propylene, 1-butene, 1-pentene, 1-hexene and 4-methyl-l-pentene, and 1-butene is preferable. Stylene elastomers include, for example, stylene-ethylene/butylene-stylene block copolymer (SEES), stylene-butadiene-stylene block copolymer (SBS), stylene-isoprene-stylene block copolymer (SIS) , modified SEES modified by maleic acid or the like, stylene-ethylene/propylene-stylene block copolymer (SEPS), stylene-ethylene/butylene block copolymer (SEE) and stylene-ethylene/propylene block copolymer (SEP) rethane elastomers include commercial products such as thermoplastic polyurethane manufactured by Dainichiseika Color & Chemicals Mfg. Co., Ltd. (product name "RESAMINE P") and thermoplastic polyurethane manufactured by KYOWA HAKKO CHEMICAL Co., Ltd. (product name "ESTEN"). In terms of adhesiveness to the other layers (for example, cyclic olefin polymer layer) in the multilayer substrate film and safety as the medical gas barrier film, among the above-mentioned elastomers, polyolefin elastomers are used preferably, and ethylene-a-olefin copolymer elastomers are used more preferably. From the similar viewpoint, a mixture of the above-mentioned elastomer, linear polyethylene having a density of 0.910 to 0.930 cm3 and high-density polyethylene having a density of 0.950 to 0.970 cm3, in which the linear polyethylene and the high-density polyethylene are mixed in the entire elastomer layer by 20 to 30 weight % and 3 to 10 weight %, respectively, may be used for the elastomer layer. The ratio of the elastomer layer (when two or more elastomer layers are provided, the sum of each elastomer layer) to the multilayer substrate film in thickness is preferably 55 to 80 % and the sum of each elastomer layer to the multilayer substrate film in thickness to the entire medical gas barrier film is 43 to 62 %. The thickness of the elastomer layer is preferably 80 to 125 μm. The heat sealing layer constitutes an innermost layer when the medical bag is formed using the medical gas barrier film of the present invention. Materials for the heat sealing layer include polyolefin, for example. Above all, polyethylene is preferable and linear polyethylene having a density of 0.925 to 0.945 cm3 is more preferable. When a medical bag having a plurality of storage chambers (so-called multi-chamber bag) is formed using the medical gas barrier film of the present invention, it is required that peelable seal is formed at each of partitions separating the storage chambers from each other. In this case, to facilitate formation of peelable seal,' a resin such as polypropylene that has a different melting point from the polyethylene and is incompatible with the polyethylene should be mixed to the polyethylene by 10 to 40 weight %. The ratio of the heat sealing layer to the multilayer substrate film in thickness is preferably 10 to 25 % and the ratio of the heat sealing layer to the entire medical gas barrier film in thickness is preferably 8 to 19%. The thickness of the heat sealing layer is preferably 15 to 30 μm. To improve formability, it is preferred that the polyethylene layer is disposed as an outermost layer in the multilayer substrate film. Polyethylene forming the polyethylene layer in the muitnayer substrate film is not specifically limited. For example, linear polyethylene having a density of 0.930 to 0.950 cmj or the above-mentioned linear polyethylene to which high-density polyethylene having a density of 0.950 to 0.970 cm3 is added by 15 to 40 weight % may be used. The ratio of the polyethylene layer to the multilayer substrate film in thickness is preferably 20 to 30 % and the ratio of the polyethylene layer to the entire medical gas barrier film in thickness is 14 to 24 %. The thickness of the polyethylene layer is preferably 30 to 50 μm. The specific example of the multilayer substrate film is not limited to this, but for example, a five-layer laminated body in which a pair of the elastomer layers are disposed on both surfaces of the cyclic olefin polymer layer, the heat sealing layer is disposed on the surface on the opposite side to the adhered surface of one elastomer layer to the cyclic olefin polymer layer and the polyethylene layer is disposed on the surface on the opposite side to the adhered surface of the other elastomer layer to the cyclic olefin polymer layer may be used. Alternatively/ a four-layer laminated body having no polyethylene layer may be also used. The multilayer substrate film may be manufactured by molding resin and elastomer materials forming the laminated body, according to various coextruding methods . The multilayer substrate f i lm may be formed as a cylindrical inflation film according to an inflation method. In this case, the heat sealing layer needs to be molded so as to be disposed on the inner side of the inflation film. The medical gas barrier f i lm of the present invention may be manufactured by laminating the multilayer gas barrier film and the multilayer substrate film according to a known method. As a laminating method, the above-mentioned dry lamination is preferable. Used adhesives include the same adhesives as those used in manufacture of the multilayer gas barrier film. When the cylindrical inflation film is adopted as the multilayer substrate film, the multilayer gas barrier f i lm may be laminated on both the right and back surfaces of the cylindrical multilayer substrate f i lm in the state of being flatly folded. Although the thickness of the entire medical gas barrier film is not specifically limited, it is preferably 180 to 240 μm, more preferably 190 to 220 μm. Since the medical gas barrier f i lm has the deposition oriented polyester layer with the inorganic oxide deposited layer and the cyclic olefin polymer layer, excellent gas and vapor barrier properties can be obtained in the medical gas barrier film. Since (i) with respect to the oriented polyester film as its substrate, the deposited layer of the deposition oriented polyester layer is disposed on the side of the outer surface of the medical bag molded using the medical gas barrier film (that is, the side of the oriented polyamide film layer and polyethylene film layer), not on the side of the inner surface of the medical bag (that is, the side of the multilayer substrate film of the medical gas barrier film), and is protected by the oriented polyamide film layer and the polyethylene film layer, and (ii) since the oriented polyamide layer and the polyethylene layer are disposed between the deposited layer of the deposition oriented polyester layer and the outer surface of the medical bag to ensure enough thickness, even when the medical gas barrier film is subjected to heating and sterilizing treatment under high temperatures, excellent gas and vapor barrier properties can be realized, and furthermore, excellent gas and vapor barrier properties can be maintained while preventing degradation of the deposited layer (deterioration of gas and vapor properties of the medical gas barrier film over time). Since the medical gas barrier film has the polyethylene layer and the elastomer layer, sufficient flexibility is given to the whole of the film, and especially since the polyethylene layer is provided on the side closer to the film surface than the deposition oriented polyester layer and the oriented polyamide layer, creases and lines can be prevented from occurring on the surface when the infusion solution bag or the like is formed. Moreover, since the medical gas barrier film has the cyclic olefin polymer layer and the multilayer substrate film containing the cyclic olefin polymer layer is formed without using any adhesive, the compounding ingredients of the film and ingredients of the adhesive can be prevented from eluting from the surface of the heat sealing layer. The medical bag of the present invention is characterized in that it (I) is formed by welding the medical gas barrier film with the heat sealing layers facing each other, or (II) is formed by welding an open end of the multilayer substrate film in the medical gas barrier film of the present invention in which the multilayer substrate film is formed according to the inflation method. The above-mentioned medical bag in (I) maybe formed in the shape of a bag by superimposing two medical gas barrier films on each other so that their heat sealing layers face each other and heat sealing the circumferential part. Heat sealing condition in forming the circumferential part is not limited, but is a temperature of 170°C or higher, preferably 180 to 200°C for 3 to 5 seconds. The medical bag of the present invention may be a so-called multi-chamber bag having two or more storage chambers divided by the peelable sealing part. The heat sealing temperature in forming the peelable sealing part is not limited to this but may be appropriately set so that peel strength of the peelable seal falls between 5.92 to 5.88 N/lSmm, for example, even after the medical bag is subjected to sterilizing treatment under 105 to 115°C. The specific heat sealing condition is set depending on the types of the resin forming the heat sealing layer, but it is, for example, preferably 140 to 155 = C, more preferably 140 to 145°C for 4 to 5 seconds. The above-mentioned peel strength is measured according to a method "180 degrees peeling method" described in JIS Z 0237 "Adhesive Tape and Adhesive Sheet Test Method" . The peel strength is measured as a strength (N/15 mm) at the time when an elastic plastic film having a width of 15mm is cut with the peelable sealing part as a starting point and a pair of film parts of the measurement sample thus obtained are pulled in the direction of 180 degrees between them at the rate of 200 mm/minute, resulting in peeling of the peelable seal. According to the present invention, to maintain excellent gas and vapor barrier properties of the medical bag, it is desirable to use a material having excellent gas and vapor barrier properties for a mouth member of the medical bag. Such mouth member (mouth port, etc.) is, for example, a polyethylene mouth member having an ethylene-vinyl alcohol copolymer (EVOH) layer, a cyclic olefin polymer layer and so on therein. It is preferred that the medical bag of the present invention is subjected to heating and sterilizing treatment in the state of being filled with a medical fluid and sealed. According to the medical bag of the present invention, since the medical gas barrier film forming the medical bag has the cyclic olefin polymer layer and the deposited layer of the deposition oriented polyester layer in the multilayer gas barrier film is disposed on the opposite side to the multilayer substrate film and protected by the oriented polyamide layer, even heating and sterilizing treatment under high temperatures is performed, excellent gas and vapor properties can be realized and deterioration of the deposited layer can also be prevented to maintain excellent gas and vapor properties. Furthermore/ according to the medical bag of the present invention, since the medical gas barrier film forming the medical bag has the cyclic olef in polymer layer, and the multilayer substrate film including the cyclic olefin polymer layer is formed without using any adhesive and is disposed on the inner side of the medical bag than the multilayer gas barrier film using the adhesive in lamination, compounding ingredients of the film and ingredients of the adhesive can be prevented from eluting. Examples Next, although the present invention will be described in more detail on the basis of examples and comparative examples, the present invention is not limited by the following examples. Manufacture of the medical gas barrier film and the medical bag> Example 1 (1) Manufacture of a multilayer gas barrier film Three layers of an alumina deposition oriented polyester layer 11, an oriented polyamide layer 15 and a polyethylene layer 17 were laminated in this order via adhesive layers (14, 16) formed of the following adhesive according to dry lamination to manufacture a multilayer gas barrier f i lm 10 having a whole thickness of 60 pm ( r e f e r to Fig. 1). In manufacturing the multilayer gas barrier f i lm 10, the oriented polyamide layer 15 was laminated on a surface lla of a deposited layer 13 of the alumina deposition oriented polyester layer 11 via an adhesive layer 14 . The polyethylene layer 17 was laminated on a surface 15b on the opposite side to an adhered surface 15a of the oriented polyamide layer 15 to the deposited layer 13. Materials used to manufacture the multilayer gas barrier f i lm 10 are as follows: • Alumina deposition oriented polyester film: Alumina is deposited on the biaxial oriented PET f i lm (The whole thickness of the deposited layer 13 and the oriented polyester film 12 is 12 urn and the thickness of the deposited layer 13 is approximately 20 urn. Transparent barrier film manufactured by Toppan Printing Co., Ltd, product name "GLA-AEH") •Oriented polyamide film: Biaxial oriented nylon f i lm (Thickness of 15 urn, manufactured by Unitika Ltd., product name "EMBLEM ONMB") •Polyethylene film: Three-layer co-extrusion f i lm formed of a linear polyethylene 18 having a thickness of 20 urn (density 0. 920g/cm3, MFR 1.0 g/10 minutes ( 1 9 0 ° C ) ) , manufactured by Mitsui Chemicals, Inc., product name "ULTZEX 2010") and high-density polyethylene 19 and 20 each having a thickness of 5 urn which are disposed on both surfaces of the polyethylene 18 (density 0.950g/cm3, melt flow rate (MFR) 1.1 g/10 minutes (190°C), manufactured by Mitsui Chemicals, Inc., product name "HI-ZEX 3300F") •Adhesive: Manufactured by Mitsui Takeda Chemicals, Inc., product name "TAKELAC A 315" (2) Manufacture of a multilayer substrate film A cylindrical multilayer substrate film (whole thickness of 160 vim) 22 of five-layer configuration formed of a heat sealing layer 23 having a thickness of 25 um, a first elastomer layer 24 having a thickness of 55 urn, a cyclic olefin polymer layer 25 having a thickness of 10 um, a second elastomer layer 26 having a thickness of 55 um and a polyethylene layer 27 having a thickness of 15 um, in which the heat sealing layer 23 is disposed on its innermost side, is manufactured (refer to Fig. 1). Materials for each layer forming the multilayer substrate film 22 are as follows: •The heat sealing layer 23: Linear polyethylene (density 0.930 g/cm3, manufactured by Mitsui Chemicals, Inc., product name "ULTZEX 3020L", MFR 2.1 g/10 minutes (190'C)) • The first elastomer layer 24 and the second elastomer layer 26: Mixed resin of linear polyethylene elastomer (density 0.885 g/cm3, manufactured by Mitsui Chemicals, Inc. , product name "TAFMER A05 85", MFR 0.5 g/10 minutes (190°C)) by 70 weight %, linear polyethylene (density 0.920 g/cm3, manufactured by Mitsui Chemicals, Inc., product name "ULTZEX 2010", MFR 1.0 g/10 minutes (190°C)) by 25 weight % and high-density polyethylene (density 0.965 g/cm3, manufactured by Mitsui Chemicals, Inc., product number "NZ 65150", MFR 16 g/10 minutes (190°C)) by 5 weight % •The cyclic olefin polymer layer 25: Hydrogenated norbornene ring-opened polymer (product name "ZEONOR 1020R" manufactured by ZEON Corporation, specific gravity 1.01, glass transition temperature (Tg 105°C)} •The polyethylene layer 27: Mixed resin of linear polyethylene (density 0.940 g/cm3, manufactured by Mitsui Chemicals, Inc., product name "ULTZEX 4020L", MFR 2 .1 g/10 minutes (190*C)) by 75 weight % and high-density polyethylene (density 0.965 g/cm3, manufactured by Mitsui Chemicals, Inc., product number "NZ 65150", MFR 16 g/10 minutes (190°C)) by 25 weight % (3) Manufacture of the medical gas barrier film The right and back surfaces of the multilayer substrate film obtained in the above (2) in the state of being flatly folded (that is, the surface on the side of the polyethylene layer 27 of the multilayer substrate film 22) and the surface on the side of the alumina deposition oriented polyester film of the multilayer gas barrier film obtained in the above (1) (the surface lib on the opposite side to the deposited layer 13) were laminated via a layer 21 formed of the above-mentioned adhesive according to dry lamination. In this manner, a cylindrical medical gas barrier film having the layer configuration shown in Fig. 1. (4) Manufacture of a medical bag One open end 31 of the cylindrical medical gas barrier film obtained in the above (3) was heat sealed with a below-mentioned mouth member 34 being sandwiched and the other open end 32 and a circumferential part 33 of the multilayer gas barrier film laminated en the surface of the multilayer substrate film were heat sealed to obtain a medical bag 30 shown in Fig. 2. A mouth port 34 formed of polyethylene and having a layer of ethylene-vinyl alcohol copolymer (EVOH) in the middle thereof was used as the mouth member. The open ends 31 and 32 and the circumferential part (joint part of the multilayer gas barrier film laminated on the surface of the multilayer substrate film) 33 of the medical gas barrier film were heat sealed at 170°C for 4.5 seconds. Following preheating at 740"C, the mouth port 34 was fixed via the medical gas barrier film by heat sealing at 160'C for 4.5 seconds. A storage chamber of the medical bag 30 was filled with distilled water of 500 ml and sealed. Example 2 (1) Manufacture of a multilayer gas barrier film A multilayer gas barrier film was prepared in the same manner as (1) of Example 1. (2) Manufacture of a multilayer substrate film A multilayer substrate film was manufactured in the same way as (2) of Example 1 except that, in place of the heat sealing layer (thickness of 25 pm) 23 of Example 1, nixed resin of linear polyethylene (density 0.940 g/cirr, manufactured by Mitsui Chemicals, Inc., product name "ULTZEX 4020L", MFR 2.1 g/ 10 minutes (190°C)) by 85 weight % and polypropylene (density 0.910 g/cm3, nanufactured by Mitsui Chemicals, Inc., product number "J103WA") by 15 weight % was used as the heat sealing layer. (3) Manufacture of a medical gas barrier film A medical gas barrier film was prepared in the same way as (3) of Example 1 except that the multilayer substrate film obtained in the above (2) was used as the multilayer substrate film in place of the film prepared in Example 1. (4) Manufacture of a medical bag One open end 41 of the cylindrical medical gas barrier film obtained in the above (3) was heat sealed in the state of sandwiching the same mouth member (mouth port 34) as that used in Example 1, the other open end 42 and a joint part (circumferential part) 43 of the multilayer gas barrier film laminated on the surface of the multilayer substrate film were heat sealed and further a peelable sealing part 44 was formed in a storage chamber of a medical bag to obtain a medical bag (multi-chamber bag) 40 shown in Fig. 4. The open ends 41 and 42 and the circumferential part (joint part of the multilayer gas barrier film laminated on the multilayer substrate film) 43 of the medical gas barrier film were heat sealed at 170°C for 4.5 seconds and the peelable sealing part 44 was heat sealed at 130°C for 4.5 seconds. Following preheating at 740°C, the mouth port was fixed via the medical gas barrier film by heat sealing at 160"C for 4.5 seconds. A large storage chamber 45 of the medical bag 40 was filled with distilled water of 700 ml and a small storage chamber 46 was filled with distilled water of 300 ml and the both chambers 45 and 46 were sealed. Comparative example 1 A medical gas barrier film was manufactured in the same manner as in Example 1 except that the cyclic olefin polymer layer 25 is not provided in the multilayer substrate film 22 of the medical gas barrier film having the layer configuration shown in Fig. 1. The medical bag shown in Fig. 2 was manufactured in the same manner as in Example I except that the medical gas barrier film thus obtained was used. Comparative example 2 A medical gas barrier film was manufactured in the same manner as in Example 1 except that, in the deposition oriented polyester layer 11 of the multilayer gas barrier film 10 in the medical gas barrier film having the layer configuration shown in Fig. 1, the direction of laminating the oriented polyester film 12 and the deposited layer 13 was reversed. The medical bag shown in Fig. 2 was manufactured in the same manner as in Example 1 except that the medical gas barrier film thus obtained was used. Comparative example 3 A medical gas barrier film was manufactured in the same manner as in Example 1 except that the polyethylene layer 17 of the multilayer gas barrier film was not provided and the thickness of the oriented polyamide layer was 30 μm in the medical gas barrier film having the layer configuration shown in Fig. 1. The medical bag shown in Fig. 2 was manufactured in the same manner as in Example 1 except that the medical gas barrier film thus obtained was used. (1) Elution test, etc. The medical bags obtained in Examples 1 and 2 and Comparative examples 1 to 3 were subjected to high pressure steam sterilizing treatment (110°C, 60 minutes) and then test pieces were cut. Using the test pieces thus obtained, an "acute toxicity test", a "sensitization test" and a "hemolysis test" in conformance with rules of The Japanese Pharmacopoeia (14th revision), Part 1 "55. Test Methods for Plastic Containers - 2. Extraction Test" and "55. -7. Cytotoxicity Test" and The Japanese Pharmacopoeia (14tn version), Part 2 "13. Plastic Containers for Pharmaceutical Products " (Guideline on Basic Biological Tests of Medical Devices and Biomedical Materials, I. Cytotoxicity Test 10. Cytotoxicity Test Using Medical Devices and Extraction Liquid of Materials, II. Sensitization Test and VII. Hemolysis Test) were performed. (2) Measurement of transparency, oxygen transmission rate, etc. Further, using the test pieces, tests according to The Japanese Pharmacopoeia (14th revision), Part 1 "55. Test Methods for Plastic Containers - 4. Transparency Test" and "55. -5. Water Vapor Permeability" were performed, and oxygen transmission rate and sterilization shrinkage rate were measured. Oxygen transmission rate (cm3/m3/day) was measured under the conditions of temperature of 20'C and humidity of 60 %RH using an oxygen transmission rate measuring device (manufactured by MOCON Inc. (US), model name "OXTRAN 2/20"). Oxygen transmission rate is preferably 0.2 cm3/m3/day or less, more preferably 1 cm3/m3/day or less. Sterilization shrinkage rate (%) calculated by comparing test pieces cut from the medical bag before being subjected to high pressure steam sterilizing treatment with the above-mentioned test pieces in length shows the rate at which the medical gas barrier film is shrunk due to high pressure steam sterilizing treatment. Sterilization shrinkage rate is preferably 2.5 % or less, more preferably 1.0 % or less, in MD and preferably 2.5 % or less, more preferably 1.0 % or less, in TD. (3) Drop test 15 medical bags obtained in each of Example 1 and 2 and Comparative example 1 to 3 were subjected to high pressure steam sterilizing treatment (IIO'C, 60 minutes) and then, five medical bags of each example were stacked in the state of being horizontally arranged, contained in an outer housing and stored at 0°C for two days. After storage, the medical bags were dropped from the height of 120 cm and occurrence of leakage of liquid and presence or absence of gas and vapor barrier properties reduction were confirmed. With respect to gas and vapor barrier properties, oxygen transmission rate and vapor transmission rate after the drop test were measured in the same manner as the above-mentioned manner and when oxygen transmission rate exceeded 0.2 cm3/m3/day and vapor transmission rate exceeded 0.27 g/mVday, it was regarded that gas and vapor barrier properties were deteriorated. (4) Evaluation results The medical bags in Examples 1 and 2 satisfied reference values of all evaluation items in the tests (1) . On the contrary, in the medical bag in Comparative example I, elution of substances of the adhesive was found. It found that the medical bags in Examples 1 and 2 had transparency of 82.5 %, oxygen transmission rate of 0.04 cmVmVday (20°C, 60 %RH) , vapor transmission rate of 0.18 g/m3/day (40°C, 90 %RH) , and sterilization shrinkage rate of 1.3 (MD) and -0.3 (TD) , and showed excellent gas and vapor properties and extremely low shrinkage rate after sterilization treatment. On the contrary, it was found that the medical bags in Comparative examples 2 and 3 had increased oxygen transmission rate and vapor transmission rate by sterilization treatment and the medical bags in Comparative example 3 had lowered transparency by sterilization treatment. In the medical bags in Examples 1 and 2, even after the drop test was performed, no leakage of liquid was found and oxygen transmission rate and vapor transmission rate hardly changed. On the contrary, in the medical bags in Comparative example 2 contained in two of three outer housings, leakage of liquid was generated. Even in the medical bags generating no leakage of liquid, increase in oxygen transmission rate and vapor transmission rate was observed. In the medical bags in Comparative example 3, drop of flexibility and resulting occurrence of creases and lines were observed. The present invention is not limited to the above-mentioned descriptions and can be variously modified in design as long as it falls within the scope of matters stated in claims. While the present invention has been described by way of the embodiments thereof, these embodiments are merely illustrative, but not limitative of the invention. Variations of the present invention apparent to those skilled in the art are to fall within the scope of the present invention defined by the appended claims. Industrial Applicability The medical gas barrier film of the present invention is suitable for a material for medical bags for storing medicine which is easy to deteriorate due to gas such as oxygen, vapor and the like in medical applications. The medical bag of the present invention is suitable for medical applications, especially for storing medicine which is easy to deteriorate due to gas such as oxygen, vapor and the like. Claims 1. A medical gas barrier film comprising a multilayer gas barrier film and a multilayer substrate film adhered to the multilayer gas barrier film, wherein the multilayer gas barrier film includes a deposition oriented polyester layer having a deposited layer of an inorganic oxide on one surface, an oriented polyamide layer adhered to a surface of the deposited layer of the deposition oriented polyester layer and a polyethylene layer adhered to a surface on the opposite side to an adhered surface of the oriented polyamide layer to the deposited layer, the multilayer substrate film includes a cyclic olef in polymer layer, an elastomer layer and a heat sealing layer and is adhered to the other surface of the deposition oriented polyester layer, and the heat sealing layer is disposed on the surface on the opposite side to the adhered surface of the multilayer substrate film to the deposition oriented polyester layer. 2. A medical gas barrier film as stated in claim 1, wherein the multilayer substrate film has a cyclic olefin polymer layer, a first elastomer layer adhered to one surface of the cyclic olefin polymer layer, a heat sealing layer on the opposite side to an adhered surface of the first elastomer layer to the cyclic olefin polymer layer, a second elastomer layer adhered to the other surface of the cyclic olefin polymer layer and a polyethylene layer adhered to a surface on the opposite side to an adhered surface of the second elastomer layer to the cyclic olefin polymer layer. 3. A medical gas barrier film as stated in claim 2, wherein a total thickness of the first elastomer layer and the second elastomer layer is 55 to 80 % of a thickness of the multilayer substrate film. 4. A medical gas barrier film as stated in claim 1, wherein a thickness of the polyethylene layer of the multilayer gas barrier film is 1 or 2 times larger than a total thickness of the deposition oriented polyester layer and the oriented polyamide layer. 5. A medical gas barrier film as stated in claim 1, wherein the polyethylene layer of the multilayer gas barrier film is a three-layer film formed of a linear polyethylene film having a density of 0.910 to 0.930 g/cm3 and high density polyethylene films each having a density of 0.950 to 0.970 g/cm3 and adhered to both surfaces of the linear polyethylene layer, and a thickness of each of the high density polyethylene films is 0.2 to 0.3 time larger than that of the linear polyethylene film. 6. A medical gas barrier film as stated in claim 1, wherein the inorganic oxide is alumina. 7. A medical gas barrier film as stated in claim 1, wherein the multilayer substrate film is a cylindrical film formed by inflation molding and an innermost layer of the cylindrical film is the heat sealing layer. 8. Amedicalbag formed by welding a medical gas barrier film so that heat sealing layers thereof face each other, wherein the medical gas barrier film comprises a multilayer gas barrier film and a multilayer substrate film adhered to the multilayer gas barrier film, the multilayer gas barrier film includes a deposition oriented polyester layer having a deposited layer of an inorganic oxide on one surface, an oriented polyamide layer adhered to a surface of the deposited layer of the deposition oriented polyester layer and a polyethylene layer adhered to a surface on the opposite side to an adhered surface of the oriented polyamide layer to the deposited layer, the multilayer substrate film includes a cyclic olef in'polymer layer, an elastomer layer and a heat sealing layer and is adhered to the other surface of the deposition oriented polyester layer, and the heat sealing layer is disposed on a surface on the opposite side to an adhered surface of the multilayer substrate film to the deposition oriented polyester layer. 9. A medical bag formed by welding an open end of a multilayer substrate film in a medical gas barrier film, wherein the medical gas barrier film comprises a multilayer gas barrier film and a multilayer substrate film adhered to the multilayer gas barrier film, the multilayer gas barrier film includes a deposition oriented polyester layer having a deposited layer of an inorganic oxide on one surface, an oriented polyamide layer adhered to a surface of the deposited layer of the deposition oriented polyester layer and a polyethylene layer adhered to a surface on the opposite side to an adhered surface of the oriented polyamide layer to the deposited layer, the multilayer substrate film is a cylindrical film formed by inflation molding, includes a cyclic olefin polymer layer, an elastomer layer and a heat sealing layer and is adhered to the other surface of the deposition oriented polyester layer, the heat sealing layer is disposed on a surface on the opposite side to an adhered surface of the multilayer substrate film to the deposition oriented polyester layer, and an innermost layer of the cylindrical multilayer substrate film is the heat sealing layer. 10. Amedical bag as stated in claim 8, the whole of which is subjected to heating and sterilization after being filled with a medical fluid and sealed. 11 . A medical bag as stated in claim 9, the whole of which is subjected to heating and sterilization after being filled with a medical fluid and sealed. 12. A medical gas barrier film substantially as herein described with reference to the foregoing description and the accompanying drawings. 13. A medical bag barrier film substantially as herein described with reference to the foregoing description and the accompanying drawings.

Full Text

Description
MEDICAL GAS BARRIER FILM AND MEDICAL BAG USING THE SAME
Technical Field
The present invention relates to a gas barrier film
suitable for medical applications and capable of
maintaining excellent gas and vapor barrier properties and
restricting elution of compounding ingredients of the film
and ingredients of an adhesive without impairing
flexibility, transparency and impact resistance of the
film even after heating and sterilizing treatment and long
storage, and a medical bag using the gas barrier film.
Background Art
Plastic bags such as infusion solution bags have
advantages of easy handling and simple disposal after use.
Currently, polyethylene as a safe material is generally
used for plastic bags prevailing in the field of medical
containers.
However, since polyethylene is a plastic having high
gas permeability, when easily oxidized medicine such as
amino acid is contained in a medical bag, the medical bag
is generally held in a plastic outer bag having gas barrier
property together with an oxygen absorber.
On the other hand, to reduce costs of the outer bag,
there has been a demand to impart gas barrier property to
the medical bag itself and various plastic materials
having gas barrier property as well as properties
including flexibility, transparency and impact resistance
have been considered.
A plastic material described in Patent document 1
is characterized in that it is a multilayer film having
a heat sealing resin layer, a biaxial oriented polyester
resin film with an inorganic oxide deposited layer, a
biaxial oriented polyamide resin film and a surface
protective film, wherein the deposited layer of the
biaxial oriented polyester resin film is adhered to the
heat sealing resin layer, the surface on the opposite side
to the deposited surface of the biaxial oriented polyester
resin film is adhered to one surface of the biaxial
oriented polyamide resin film, and the surface protective
film is disposed on the other surface of the biaxial
oriented polyamide resin film.
A plastic material described in Patent document 2
is characterized in that it is a multilayer film having
a polyethylene layer forming a heat sealing part, a cyclic
olefin polymer layer and a polyethylene terephthalate
layer with an inorganic oxide deposited layer, wherein the
polyethylene layer is adhered to one surface of the cyclic
olefin polymer layer and the deposited layer of the
polyethylene terephthalate layer is adhered to the other
surface of the cyclic olefin polymer layer.
A plastic material described in Patent document 3
is characterized in that it is a multilayer film having
a heat sealing layer (ethylene polymer), a biaxial
oriented film (biaxial oriented polyethylene) substrate
with an inorganic oxide deposited layer and a protective
film (biaxial oriented polyamide film), wherein the heat
sealing layer is adhered to the surface on the opposite
side to the inorganic oxide deposited layer of the biaxial
oriented film substrate, and the protective film is
adhered to the surface of the inorganic oxide deposited
layer of the biaxial oriented film substrate.
[Patent document 1] Japanese Unexamined Patent
Publication No. 2004-58336
[Patent document 2] Japanese Unexamined Patent
Publication No. 2001-157705
[Patent document 3] Japanese Unexamined Patent
Publication No. 2004-148681
Disclosure of the Invention
Problems to be Solved by the Invention
Medical bags require, for example, heat resistance
to heating and sterilizing treatment and safety to drugs
contained therein (especially, low elution behavior of
compounding ingredients of a resin film and ingredients
of an adhesive) in addition to properties such as
flexibility, transparency and impact resistance, which
are required for conventional plastic bags. However, in
the present circumstances, a plastic material which
fulfills all of the properties has not been found.
The multilayer films disclosed in Patent documents
1 to 3 have a common problem that flexibility is low and
thus creases and lines are easy to generate when an
infusion solution bag or the like is formed of the films.
Further, the multilayer films described in Patent
documents 1 and 2 have the problem that gas and vapor
barrier properties are easy to lower over time since the
deposited layer of the polyester (polyethylene
terephtalate) film substrate is disposed at the side of
an inner surface of a packaging body using the multilayer
films. The multilayer films described in Patent
documents 1 and 3 have the problem that the adhesive used
for adhesion between the layers is eluted. In the
multilayer films described in Patent documents 2 and 3,
since the thickness between an outer surface of a packaging
body using the multilayer films and the deposited layer
is small, gas and vapor properties can lower over time.
An object of the present invention is to provide a
gas barrier film suitable for medical applications capable
of realizing excellent gas and vapor barrier properties
while maintaining flexibility, transparency and impact
resistance of the film and controlling elution of
compounding ingredients of the film and ingredients of an
adhesive even after heating and sterilizing treatment and
long storage, and a medical bag using the gas barrier film.
Means for Solving Problems
To solve the above-mentioned problems, the present
invention provides
(1) a medical gas barrier film comprising a multilayer
gas barrier film and a multilayer substrate film adhered
to the multilayer gas barrier film, wherein the multilayer
gas barrier film includes a deposition oriented polyester
layer having a deposited layer of an inorganic oxide on
one surface, an oriented polyamide layer adhered to the
surface of the deposited layer of the deposition oriented
polyester layer and a polyethylene layer adhered to the
surface on the opposite side to the adhered surface of the
oriented polyamide layer to the deposited layer, the
multilayer substrate film includes a cyclic olefin polymer
layer, an elastomer layer and a heat sealing layer and is
adhered to the other surface of the deposition oriented
polyester layer, and the heat sealing layer is disposed
on the surface on the opposite side to the adhered surface
of the multilayer substrate film to the deposition
oriented polyester layer,
(2) a medical gas barrier film as stated in the above
(1), wherein the multilayer substrate film has a cyclic
olefin polymer layer, a first elastomer layer adhered to
one surface of the cyclic olefin polymer layer, a heat
sealing layer on the opposite side to the adhered surface
of the first elastomer layer to the cyclic olefin polymer
layer, a second elastomer layer adhered to the other
surface of the cyclic olefin polymer layer and a
polyethylene layer adhered to the surface on the opposite
side to the adhered surface of the second elastomer layer
to the cyclic olefin polymer layer,
(3) a medical gas barrier film as stated in the above
(2), wherein the total thickness of the first elastomer
layer and the second elastomer layer is 55 to 80 % of the
thickness of the multilayer substrate film,
(4) a medical gas barrier film as stated in the above
(1), wherein the thickness of the polyethylene layer of
the multilayer gas barrier film is 1 or 2 times larger than
the total thickness of the deposition oriented polyester
layer and the oriented polyamide layer,
(5) a medical gas barrier film as stated in the above
(1) , wherein the polyethylene layer of the multilayer gas
barrier film is a three-layer film formed of a linear
polyethylene film having a density of 0.910 to 0.930 g/cm3
and high density polyethylene films each having a density
of 0.950 to 0.970 g/cm3 and adhered to both surfaces of
the linear polyethylene layer, and the thickness of each
high density polyethylene film is 0.2 to 0.3 time larger
than that of the linear polyethylene film,
(6) a medical gas barrier film as stated in the above
(I), wherein the inorganic oxide is alumina,
(7) a medical gas barrier film as stated in the above
(I), wherein the multilayer substrate film is a
cylindrical film formed by inflation molding and an
innermost layer of the cylindrical film is the heat sealing
layer,
(8) a medical bag formed by welding a medical gas barrier
film so that heat sealing layers thereof face each other,
wherein the medical gas barrier film comprises a
multilayer gas barrier film and a multilayer substrate
film adhered to the multilayer gas barrier film, the
multilayer gas barrier film includes a deposition oriented
polyester layer having a deposited layer of an inorganic
oxide on one surface, an oriented polyamide layer adhered
to the surface of the deposited layer of the deposition
oriented polyester layer and a polyethylene layer adhered
to the surface on the opposite side to the adhered surface
of the oriented polyamide layer to the deposited layer,
the multilayer substrate film includes a cyclic olefin
polymer layer, an elastomer layer and a heat sealing layer
and is adhered to the other surface of the deposition
oriented polyester layer, and the heat sealing layer is
disposed on the surface on the opposite side to the adhered
surface of the multilayer substrate film to the deposition
oriented polyester layer,
(9) a medical bag formed by welding an open end of a
multilayer substrate film in a medical gas barrier film,
wherein the medical gas barrier film comprises a
multilayer gas barrier film and a multilayer substrate
film adhered to the multilayer gas barrier film, the
multilayer gas barrier film includes a deposition oriented
polyester layer having a deposited layer of an inorganic
oxide on one surface, an oriented polyamide layer adhered
to the surface of the deposited layer of the deposition
oriented polyester layer and a polyethylene layer adhered
to the surface on the opposite side to the adhered surface
of the oriented polyamide layer to the deposited layer,
the multilayer substrate film is a cylindrical film formed
by inflation molding, includes a cyclic olefin polymer
layer, an elastomer layer and a heat sealing layer and is
adhered to the other surface of the deposition oriented
polyester layer, the heat sealing layer is disposed on the
surface on the opposite side to the adhered surface of the
multilayer substrate film to the deposition oriented
polyester layer, and an innermost layer of the cylindrical
multilayer substrate film is the heat sealing layer,
(10) a medical bag as stated in the above ( 8 ) , the whole
of which is subjected to heating and sterilization after
being filled with a medical fluid and sealed, and
(11) a medical bag as stated in the above ( 9 ) , the whole
of which is subjected to heating and sterilization after
being filled with a medical fluid and sealed.
Effects of the Invention
A gas barrier film according to the present invention
can obtain excellent gas and vapor barrier properties
while maintaining flexibility, transparency and impact
resistance of the film, and suppress degradation of gas
and vapor barrier properties with time due to heating and
sterilizing treatment and long storage as well as elution
of compounding ingredients of the f i lm and ingredients of
an adhesive.
Brief Description of the Drawings
Fig. 1 is a schematic sectional view showing the
configuration of layers of a medical gas barrier film in
accordance with an embodiment.
Fig. 2 is a front view showing a medical bag in
accordance with an embodiment.
Fig. 3 is a front view showing a medical bag in
accordance with another embodiment.
Description of Reference Numerals
10 Multilayer gas barrier film
11 Deposition oriented polyester layer
15 Oriented polyamide layer
17 Polyethylene layer
22 Multilayer substrate film
23 Heat sealing layer
24 First elastomer layer
25 Cyclic olefin polymer layer
26 Second elastomer layer
30 Medical bag
Best Mode for Carrying out the Invention
A medical gas barrier film of the present invention
comprises
(i) a multilayer gas barrier film including an
deposition oriented polyester layer having an inorganic
oxide deposited layer on one surface thereof, an oriented
polyamide layer adhered to the surface of the deposited
layer and a polyethylene layer adhered to the surface on
the opposite side to the adhered surface of the oriented
polyamide layer to the deposited layer, and
(ii) a multilayer substrate film including a cyclic
olefin polymer layer, an elastomer layer and a heat sealing
layer, and
the above (ii) multilayer substrate film is adhered
to the other surface of the deposition oriented polyester
layer in the above (i) multilayer gas barrier film, and
the heat sealing layer in the above (ii) multilayer
substrate film is disposed on the surface on the opposite
side to the surface adhered to the deposition oriented
polyester layer.
As described above, the multilayer gas barrier film
includes three layers of the layer formed of the deposition
oriented polyester film having the inorganic oxide
deposited layer on one surface thereof (hereinafter,
referred to as "deposition oriented polyester layer") , the
oriented polyamide layer adhered to the surface of the
deposited layer of the deposition oriented polyester layer
and the polyethylene layer adhered to the surface on the
opposite side to the adhered surface of the oriented
polyamide layer to the deposited layer.
The deposition oriented polyester layer is, for
example, a layer formed to impart gas barrier property to
the whole medical gas barrier film and is made by forming
the inorganic oxide deposited layer on the surface of the
polyester film subjected to orienting treatment.
Polyesters for the oriented polyester film include
polyethylene terephthalate (PET), polybutylene
terephthalate (PBT), polyethylene napthalate (PEN) and
polybutylene napthalate (PBN).
Orienting treatment of the polyester film may be
either uniaxial orientation or biaxial orientation.
Specific techniques of biaxial orienting treatment
include tubular biaxial orientation and tenter biaxial
orientation. By applying orienting treatment to the
polyester film, pinhole resistance, strength, heat
resistance in evaporating treatment, surface smoothness
of the film and the like can be improved.
Inorganic oxides forming the deposited layer include
alumina (aluminum oxide), silica (silicon oxide),
magnesium oxide and titan oxide, for example. Especially,
alumina is preferable in terms of transparency of the
deposited layer.
Specific examples of the deposition oriented
polyester film having the deposited layer made of alumina
(hereinafter, referred to as "alumina deposition oriented
polyester film") include transparent barrier films
manufactured by Toppan Printing Co., Ltd. (product name
"GL FAMILY"; "GL-AEH" (substrate: PET), "GL-AU"
(substrate: PET), "GL-AE" (substrate: PET)) and
transparent barrier films manufactured by Toray Advanced
Film Co., Ltd. (product name "BARRIER ROCKS" series;
"1011RG", "1011HG","1031HG", and so on).
The ratio of the deposition oriented polyester layer
to the multilayer gas barrier film in thickness is
preferably 15 to 35 %, more preferably 10 to 30 %, and the
ratio of the deposition oriented polyester layer to the
entire medical gas barrier film in thickness is preferably
3 to 10 %, more preferably 5 to 7 % . The thickness of the
deposition oriented polyester layer is preferably 7 to 20
urn, more preferably 9 to 15 μm.
The oriented polyamide layer is, for example, a layer
formed to protect the deposited layer of the deposition
oriented polyester layer and is made using a polyamide film
subjected to orienting treatment.
Polyamides for the oriented polyamide film include
nylon-6, nylon-6,6, nylon-6,10, nylon-6,12, nylon-11 and
nylon-12.
Orienting treatment of the polyamide film may be
either uniaxial orientation or biaxial orientation.
Specific techniques of biaxial orienting treatment
include tubular biaxial orientation and tenter biaxial
orientation, for example. By applying orienting
treatment to the polyamide film, pinhole resistance,
strength, heat resistance in evaporating treatment,
surface smoothness of the film and the like can be
improved.
Specific examples of the oriented polyamide film
include biaxial oriented nylon films manufactured by
Unitica Ltd. (product name "EMBLEM (registered trademark)
series; "EMBLEM ONMB", and so on).
The ratio of the oriented polyamide layer to the
multilayer gas barrier film in thickness is preferably 15
to 35 %, more preferably 20 to 30 %, and the ratio of the
oriented polyamide layer to the entire medical gas barrier
film in thickness is preferably 3 to 10 %, more preferably
5 to 10 %. The thickness of the oriented polyamide layer
is preferably 7 to 20 um, more preferably 10 to 15 um.
The polyethylene layer in the multilayer gas barrier
film is an outermost layer of a medical bag in the case
where the medical bag is formed using the medical gas
barrier film of the present invention, and for example,
a layer formed to protect the surface of the medical gas
barrier film and add soft touch to the medical gas barrier
film.
The polyethylene film forming the polyethylene layer
is not limited by density range such as high density and
low density, molecular structure such as straight chain,
and manufacturing methods such as high-pressure process
and low-pressure process, and various polyethylene films
may be used.
The polyethylene film may be formed of one type of
polyethylene or a composite of two or more types of
polyethylene.
Further, the polyethylene film may be a multilayer
film formed of two or more types of polyethylene . Specific
examples of the multilayer film include a three-layer film
in which high density polyethylene having a density of
0.950 to 0.970 g/cm3 is disposed on both surfaces of a
linear polyethylene film having a density of 0.910 to 0.930
g/cm3.
When the above-mentioned three-layer film is used
as the polyethylene film forming the polyethylene layer,
properties such as formability and strength of the medical
gas barrier film of the present invention can be further
improved. The ratio of the high density polyethylene in
the three-layer film to the linear polyethylene in
thickness is preferably 0.2 to 0.3, more preferably 0.22
to 0.28.
The thickness of the polyethylene layer is
preferably 1 to 2 times, more preferably 1.2 to 1.8 times,
larger than that of the sum of the alumina deposition
oriented polyester layer and the oriented poly amide layer .
The thickness of the polyethylene layer is preferably 5
to 30 urn.
The multilayer gas barrier film can be manufactured
by separately molding three types of films of the alumina
deposition oriented polyester layer, the oriented
polyamide layer and the polyethylene layer and then
laminating the films according to various laminating
methods.
Various laminating methods can be adopted and a dry
laminating method wherein an adhesive is used is the most
preferable among them.
Although the thickness of the entire multilayer gas
barrier film is not specifically limited, the thickness
of 30 to 80 um is preferable.
Various adhesives used for manufacture of the
laminated film can be adopted as an adhesive used in the
dry laminating method. The adhesives include "TAKELAC"
series (product name "TAKELAC A315", etc.) and "TAKENATE"
series (product name) manufactured by Mitsui Takeda
Chemicals Co., Ltd.
The less the amount of ingredients of the adhesive
eluted from the multilayer gas barrier film is, the better
the adhesive is. Such adhesives include adhesives for dry
lamination comprising at least a base compound and a
stiffener, and the following combinations of the base
compound and the stiffener are included (Refer to Japanese
Unexamined Patent Publication No. 2000-309770, Japanese
Unexamined Patent Publication No. 2000-351953 and
Japanese Unexamined Patent Publication No. 2002-155260) .
Base compound: polyether-polyurethane resin formed
by extending a resin consisting of polyether and glycols
and/or amines with diisocyanates; polyester resin formed
of at least one type of acids selected from the group
consisting of aromatic carboxylic acid, alicyclic
carboxylic acid, aliphatic carboxylic acid and
unsaturated carboxylic acid, esters or lactones of the
above carboxylic acid and at least one type of glycols;
polyester-urethane-diol resin formed by extending the
above-mentioned polyester resin with diisocyanates;
polyester resin formed of at least one type selected from
the group consisting of dimer fatty acids and their esters
and at least one type of glycols (at least one type of
grycols selected from the group consisting of aromatic
dicarboxylic acids and their ester compounds);
polyester-urethane-diol resin formed by extending the
polyester resin with diisocyanates;
polyester-urethane-diol resin formed by extending the
polyester diol resin formed of at least one type selected
from the group consisting of dimer fatty acids,
hydrogenated dimer fatty acids and ester and at least one
type of glycols with diisocyanates.
Stiffener: isocyanates adduct of trimethylolpropane,
buret or trimer of diisocyanates.
The multilayer gas barrier film can be manufactured
by adopting an extrusion laminating method in place of the
dry laminating method. In this case, an adhesive resin
may be used in place of the above-mentioned adhesive and
molding conditions of the publicly known extrusion
laminating method can be employed.
Adhesive resins preferably include, for example,
nodified polyolefin obtained by graft copolymerizing
polyolefin such as polyethylene with unsaturated
carboxylic acid such as maleic acid, fumaric acid,
tetrahydrophthalic adid, itaconic acid, citraconic acid,
crotonic acid, isocrotonic acid, nagic acid, acrylic acid
and methacryl acid or anhydrides of these acids.
As described above, the multilayer substrate film
is provided on the other surface (the surface on the
opposite side of the surface on which the deposited layer
is formed) of the deposition oriented polyester layer in
the multilayer gas barrier film, and is a laminated body
having the cyclic olefin polymer layer, the elastomer
layer and the heat sealing layer.
The cyclic olefin polymer layer is provided to
prevent ingredients of the adhesive from exuding from the
multilayer gas barrier film and permeation of moisture
from exerting a negative impact such as peeling on the
deposited layer of the deposition oriented polyester film,
for example.
Cyclic olefin polymers forming the cyclic olefin
polymer layer include, for example, a copolymer of
ethylene and dicyclopentadiene compound, a copolymer of
ethylene and norbornene compound, a ring-opened polymer
of cyclopentadiene compound, a ring-opened copolymer of
two or more types of cyclopentadiene compound and their
hydrogenated polymers and copolymers.
In particular, the hydrogenated polymers and
copolymers as saturated polymers among the
above-mentioned cyclic olefin polymers are suitable for
the material for the cyclic olefin polymer layer of the
present invention since they are especially excellent in
vapor barrier property and gas barrier property and also
excellent in the effect of preventing
absorption/adsorption of medicine, heat resistance,
transparency, stability and the like.
The hydrogenated copclymer of ethylene and
norbornene compound and the hydrogenated ring-opened
polymer (copolymer) of one or two or more types of
cyclopentadiene derivative are especially preferable
among the above-mentioned cyclic olefin polymers.
Specific examples of the cyclic olefin polymers
include a polymer having repeating unit shown in the
following general formula (1) and repeating unit shown in
the following general formula (!') and a polymer having
repeating unit shown in the following general formula (2) .
(Figure Removed)
(In the formulas, R1, R:', R2, R2', R3 and R4
independently indicate hydrogen atom, hydrocarbon residue,
halogen atom, ester, and a polar group such as nitryl and
pylidyl. R1 and R2, R1 and R2' and R" and R4 may be connected
to each other to form a ring, m, m' x and z indicate an
integer of 1 or more, and n, n' and y indicates an integer
of 1 or more).
The polymer having the repeating units shown in the
general formulas (1) and (1') is obtained by polymerizing
one or two or more types of norbornene monomers according
to a publicly known ring-opened polymerizing method or
hydrogenating the ring-opened polymer thus obtained
according to an ordinary method. On the other hand, the
polymer having a structural unit shown in the general
formula (2) is obtained by additive-copolymerizing one or
two or more types of norbornene monomers and ethylene
according to a publicly known method or hydrogenating the
copolymer thus obtained according to an ordinary method.
Although the type of cyclic olefin polymer is not
specifically limited, the glass transition temperature
(Tg) thereof is preferably 70°C or higher, more preferably
80 to 150'C. Although the molecular weight of cyclic
olefin polymer is not specifically limited, the number
molecular weight measured according to gel permeation
chromatography (GPC) analysis using cyclohexane as a
solvent is preferably 10 to 100 thousand, more preferably
20 to 50 thousand. In the case where unsaturated bonding
remaining in the molecular chain of cyclic olefin polymer
is saturated by hydrogenation, although the hydrogenation
ratio is not specifically limited, it is preferably 90 %
or more, more preferably 95 % or more, even more preferably
99 % or more.
Specific examples of the cyclic olefin polymers
include cyclic olefin polymer manufactured by Mitsui
Chemicals, Inc. (product name "APEL (registered
trademark)" series), optical resin manufactured by JSR
Corporation ("ARTON (registered trademark)"),
general-purpose transparent engineering plastics
manufactured by Zeon Corp., (product name "ZEONOR
(registered trademark)" series) and "TOPAS (product
name)" manufactured by Ticona GmbH.
In terms of compatibility with a layer adjacent to
the cyclic olefin polymer layer (for example, an elastomer
layer described later) , mixed resin of cyclic olefin
polymer and polyolefin resin may be used for the cyclic
olefin polymer layer. The polyolefin resins include, for
example, polyethylene (PE) homopolymer, copolymer of
ethylene and a-olefins having a carbon number 3 to 12 (for
example, butane-1, pentene-1, hexene-1,
4-methyl-l-pentene, cctene-1, decene-1), polypropylene
(PP) homopolymer, and copolymer of propylene and a-olefins
having a carbon number 2 to 12 (for example, ethylene,
butane-1, pentene-1, hexene-1, 4-methyl-l-pentene,
octene-1, decene-1). Above all, PE homopolymer is
preferable . An example of a preferred mode of mixed resin
of cyclic olefin polymer and polyolefin resin is that
polyethylene having a density of 0.910 to 0.930 g/cm3 is
mixed to cyclic olefin polymer by 5 to 40 weight %.
The ratio of the cyclic olefin polymer layer to the
multilayer substrate film in thickness is preferably 3 to
10 % and the ratio of the cyclic olefin polymer to the entire
medical gas barrier film in thickness is 5 to 10 %. The
thickness of the cyclic olefin polymer layer is preferably
10 to 20 μm.
To protect hard and fragile cyclic olefin polymer,
the elastomer layer is provided on the surface on each of
both sides of the cyclic olefin polymer layer.
Elastomers for the elastomer layer include
polyolefin elastomers, styrene elastomers and urethane
elastomers, for example.
Polyolefin elastomers include linear polyethylene
elastomer, ethylene-a-olefin copolymer elastomer and
propylene-a-olefin copolymer elastomer, for example.
The a-olefins include a-olefins having a carbon number of
3 to 6 such as propylene, 1-butene, 1-pentene, 1-hexene
and 4-methyl-l-pentene, and 1-butene is preferable.
Stylene elastomers include, for example,
stylene-ethylene/butylene-stylene block copolymer
(SEES), stylene-butadiene-stylene block copolymer (SBS),
stylene-isoprene-stylene block copolymer (SIS) , modified
SEES modified by maleic acid or the like,
stylene-ethylene/propylene-stylene block copolymer
(SEPS), stylene-ethylene/butylene block copolymer (SEE)
and stylene-ethylene/propylene block copolymer (SEP) rethane elastomers include commercial products
such as thermoplastic polyurethane manufactured by
Dainichiseika Color & Chemicals Mfg. Co., Ltd. (product
name "RESAMINE P") and thermoplastic polyurethane
manufactured by KYOWA HAKKO CHEMICAL Co., Ltd. (product
name "ESTEN").
In terms of adhesiveness to the other layers (for
example, cyclic olefin polymer layer) in the multilayer
substrate film and safety as the medical gas barrier film,
among the above-mentioned elastomers, polyolefin
elastomers are used preferably, and ethylene-a-olefin
copolymer elastomers are used more preferably.
From the similar viewpoint, a mixture of the
above-mentioned elastomer, linear polyethylene having a
density of 0.910 to 0.930 cm3 and high-density polyethylene
having a density of 0.950 to 0.970 cm3, in which the linear
polyethylene and the high-density polyethylene are mixed
in the entire elastomer layer by 20 to 30 weight % and 3
to 10 weight %, respectively, may be used for the elastomer
layer.
The ratio of the elastomer layer (when two or more
elastomer layers are provided, the sum of each elastomer
layer) to the multilayer substrate film in thickness is
preferably 55 to 80 % and the sum of each elastomer layer
to the multilayer substrate film in thickness to the entire
medical gas barrier film is 43 to 62 %. The thickness of
the elastomer layer is preferably 80 to 125 μm.
The heat sealing layer constitutes an innermost
layer when the medical bag is formed using the medical gas
barrier film of the present invention.
Materials for the heat sealing layer include
polyolefin, for example. Above all, polyethylene is
preferable and linear polyethylene having a density of
0.925 to 0.945 cm3 is more preferable.
When a medical bag having a plurality of storage
chambers (so-called multi-chamber bag) is formed using the
medical gas barrier film of the present invention, it is
required that peelable seal is formed at each of partitions
separating the storage chambers from each other. In this
case, to facilitate formation of peelable seal,' a resin
such as polypropylene that has a different melting point
from the polyethylene and is incompatible with the
polyethylene should be mixed to the polyethylene by 10 to
40 weight %.
The ratio of the heat sealing layer to the multilayer
substrate film in thickness is preferably 10 to 25 % and
the ratio of the heat sealing layer to the entire medical
gas barrier film in thickness is preferably 8 to 19%. The
thickness of the heat sealing layer is preferably 15 to
30 μm.
To improve formability, it is preferred that the
polyethylene layer is disposed as an outermost layer in
the multilayer substrate film.
Polyethylene forming the polyethylene layer in the
muitnayer substrate film is not specifically limited.
For example, linear polyethylene having a density of 0.930
to 0.950 cmj or the above-mentioned linear polyethylene
to which high-density polyethylene having a density of
0.950 to 0.970 cm3 is added by 15 to 40 weight % may be
used.
The ratio of the polyethylene layer to the multilayer
substrate film in thickness is preferably 20 to 30 % and
the ratio of the polyethylene layer to the entire medical
gas barrier film in thickness is 14 to 24 %. The thickness
of the polyethylene layer is preferably 30 to 50 μm.
The specific example of the multilayer substrate
film is not limited to this, but for example, a five-layer
laminated body in which a pair of the elastomer layers are
disposed on both surfaces of the cyclic olefin polymer
layer, the heat sealing layer is disposed on the surface
on the opposite side to the adhered surface of one
elastomer layer to the cyclic olefin polymer layer and the
polyethylene layer is disposed on the surface on the
opposite side to the adhered surface of the other elastomer
layer to the cyclic olefin polymer layer may be used.
Alternatively/ a four-layer laminated body having no
polyethylene layer may be also used.
The multilayer substrate film may be manufactured
by molding resin and elastomer materials forming the
laminated body, according to various coextruding methods .
The multilayer substrate f i lm may be formed as a
cylindrical inflation film according to an inflation
method. In this case, the heat sealing layer needs to be
molded so as to be disposed on the inner side of the
inflation film.
The medical gas barrier f i lm of the present invention
may be manufactured by laminating the multilayer gas
barrier film and the multilayer substrate film according
to a known method.
As a laminating method, the above-mentioned dry
lamination is preferable. Used adhesives include the
same adhesives as those used in manufacture of the
multilayer gas barrier film.
When the cylindrical inflation film is adopted as
the multilayer substrate film, the multilayer gas barrier
f i lm may be laminated on both the right and back surfaces
of the cylindrical multilayer substrate f i lm in the state
of being flatly folded.
Although the thickness of the entire medical gas
barrier film is not specifically limited, it is preferably
180 to 240 μm, more preferably 190 to 220 μm.
Since the medical gas barrier f i lm has the deposition
oriented polyester layer with the inorganic oxide
deposited layer and the cyclic olefin polymer layer,
excellent gas and vapor barrier properties can be obtained
in the medical gas barrier film.
Since (i) with respect to the oriented polyester film
as its substrate, the deposited layer of the deposition
oriented polyester layer is disposed on the side of the
outer surface of the medical bag molded using the medical
gas barrier film (that is, the side of the oriented
polyamide film layer and polyethylene film layer), not on
the side of the inner surface of the medical bag (that is,
the side of the multilayer substrate film of the medical
gas barrier film), and is protected by the oriented
polyamide film layer and the polyethylene film layer, and
(ii) since the oriented polyamide layer and the
polyethylene layer are disposed between the deposited
layer of the deposition oriented polyester layer and the
outer surface of the medical bag to ensure enough thickness,
even when the medical gas barrier film is subjected to
heating and sterilizing treatment under high temperatures,
excellent gas and vapor barrier properties can be realized,
and furthermore, excellent gas and vapor barrier
properties can be maintained while preventing degradation
of the deposited layer (deterioration of gas and vapor
properties of the medical gas barrier film over time).
Since the medical gas barrier film has the
polyethylene layer and the elastomer layer, sufficient
flexibility is given to the whole of the film, and
especially since the polyethylene layer is provided on the
side closer to the film surface than the deposition
oriented polyester layer and the oriented polyamide layer,
creases and lines can be prevented from occurring on the
surface when the infusion solution bag or the like is
formed.
Moreover, since the medical gas barrier film has the
cyclic olefin polymer layer and the multilayer substrate
film containing the cyclic olefin polymer layer is formed
without using any adhesive, the compounding ingredients
of the film and ingredients of the adhesive can be
prevented from eluting from the surface of the heat sealing
layer.
The medical bag of the present invention is
characterized in that it
(I) is formed by welding the medical gas barrier film
with the heat sealing layers facing each other, or
(II) is formed by welding an open end of the
multilayer substrate film in the medical gas barrier film
of the present invention in which the multilayer substrate
film is formed according to the inflation method.
The above-mentioned medical bag in (I) maybe formed
in the shape of a bag by superimposing two medical gas
barrier films on each other so that their heat sealing
layers face each other and heat sealing the
circumferential part.
Heat sealing condition in forming the
circumferential part is not limited, but is a temperature
of 170°C or higher, preferably 180 to 200°C for 3 to 5
seconds.
The medical bag of the present invention may be a
so-called multi-chamber bag having two or more storage
chambers divided by the peelable sealing part.
The heat sealing temperature in forming the peelable
sealing part is not limited to this but may be
appropriately set so that peel strength of the peelable
seal falls between 5.92 to 5.88 N/lSmm, for example, even
after the medical bag is subjected to sterilizing
treatment under 105 to 115°C. The specific heat sealing
condition is set depending on the types of the resin
forming the heat sealing layer, but it is, for example,
preferably 140 to 155 = C, more preferably 140 to 145°C for
4 to 5 seconds.
The above-mentioned peel strength is measured
according to a method "180 degrees peeling method"
described in JIS Z 0237 "Adhesive Tape and Adhesive Sheet
Test Method" . The peel strength is measured as a strength
(N/15 mm) at the time when an elastic plastic film having
a width of 15mm is cut with the peelable sealing part as
a starting point and a pair of film parts of the measurement
sample thus obtained are pulled in the direction of 180
degrees between them at the rate of 200 mm/minute,
resulting in peeling of the peelable seal.
According to the present invention, to maintain
excellent gas and vapor barrier properties of the medical
bag, it is desirable to use a material having excellent
gas and vapor barrier properties for a mouth member of the
medical bag.
Such mouth member (mouth port, etc.) is, for example,
a polyethylene mouth member having an ethylene-vinyl
alcohol copolymer (EVOH) layer, a cyclic olefin polymer
layer and so on therein.
It is preferred that the medical bag of the present
invention is subjected to heating and sterilizing
treatment in the state of being filled with a medical fluid
and sealed.
According to the medical bag of the present invention,
since the medical gas barrier film forming the medical bag
has the cyclic olefin polymer layer and the deposited layer
of the deposition oriented polyester layer in the
multilayer gas barrier film is disposed on the opposite
side to the multilayer substrate film and protected by the
oriented polyamide layer, even heating and sterilizing
treatment under high temperatures is performed, excellent
gas and vapor properties can be realized and deterioration
of the deposited layer can also be prevented to maintain
excellent gas and vapor properties.
Furthermore/ according to the medical bag of the
present invention, since the medical gas barrier film
forming the medical bag has the cyclic olef in polymer layer,
and the multilayer substrate film including the cyclic
olefin polymer layer is formed without using any adhesive
and is disposed on the inner side of the medical bag than
the multilayer gas barrier film using the adhesive in
lamination, compounding ingredients of the film and
ingredients of the adhesive can be prevented from eluting.
Examples
Next, although the present invention will be
described in more detail on the basis of examples and
comparative examples, the present invention is not limited
by the following examples.
Manufacture of the medical gas barrier film and the
medical bag>
Example 1
(1) Manufacture of a multilayer gas barrier film
Three layers of an alumina deposition oriented
polyester layer 11, an oriented polyamide layer 15 and a
polyethylene layer 17 were laminated in this order via
adhesive layers (14, 16) formed of the following adhesive
according to dry lamination to manufacture a multilayer
gas barrier f i lm 10 having a whole thickness of 60 pm ( r e f e r
to Fig. 1).
In manufacturing the multilayer gas barrier f i lm 10,
the oriented polyamide layer 15 was laminated on a surface
lla of a deposited layer 13 of the alumina deposition
oriented polyester layer 11 via an adhesive layer 14 . The
polyethylene layer 17 was laminated on a surface 15b on
the opposite side to an adhered surface 15a of the oriented
polyamide layer 15 to the deposited layer 13.
Materials used to manufacture the multilayer gas
barrier f i lm 10 are as follows:
• Alumina deposition oriented polyester film:
Alumina is deposited on the biaxial oriented PET f i lm (The
whole thickness of the deposited layer 13 and the oriented
polyester film 12 is 12 urn and the thickness of the
deposited layer 13 is approximately 20 urn. Transparent
barrier film manufactured by Toppan Printing Co., Ltd,
product name "GLA-AEH")
•Oriented polyamide film: Biaxial oriented nylon
f i lm (Thickness of 15 urn, manufactured by Unitika Ltd.,
product name "EMBLEM ONMB")
•Polyethylene film: Three-layer co-extrusion f i lm
formed of a linear polyethylene 18 having a thickness of
20 urn (density 0. 920g/cm3, MFR 1.0 g/10 minutes ( 1 9 0 ° C ) ) ,
manufactured by Mitsui Chemicals, Inc., product name
"ULTZEX 2010") and high-density polyethylene 19 and 20
each having a thickness of 5 urn which are disposed on both
surfaces of the polyethylene 18 (density 0.950g/cm3, melt
flow rate (MFR) 1.1 g/10 minutes (190°C), manufactured by
Mitsui Chemicals, Inc., product name "HI-ZEX 3300F")
•Adhesive: Manufactured by Mitsui Takeda Chemicals,
Inc., product name "TAKELAC A 315"
(2) Manufacture of a multilayer substrate film
A cylindrical multilayer substrate film (whole
thickness of 160 vim) 22 of five-layer configuration formed
of a heat sealing layer 23 having a thickness of 25 um,
a first elastomer layer 24 having a thickness of 55 urn,
a cyclic olefin polymer layer 25 having a thickness of 10
um, a second elastomer layer 26 having a thickness of 55
um and a polyethylene layer 27 having a thickness of 15
um, in which the heat sealing layer 23 is disposed on its
innermost side, is manufactured (refer to Fig. 1).
Materials for each layer forming the multilayer
substrate film 22 are as follows:
•The heat sealing layer 23: Linear polyethylene
(density 0.930 g/cm3, manufactured by Mitsui Chemicals,
Inc., product name "ULTZEX 3020L", MFR 2.1 g/10 minutes
(190'C))
• The first elastomer layer 24 and the second
elastomer layer 26: Mixed resin of linear polyethylene
elastomer (density 0.885 g/cm3, manufactured by Mitsui
Chemicals, Inc. , product name "TAFMER A05 85", MFR 0.5 g/10
minutes (190°C)) by 70 weight %, linear polyethylene
(density 0.920 g/cm3, manufactured by Mitsui Chemicals,
Inc., product name "ULTZEX 2010", MFR 1.0 g/10 minutes
(190°C)) by 25 weight % and high-density polyethylene
(density 0.965 g/cm3, manufactured by Mitsui Chemicals,
Inc., product number "NZ 65150", MFR 16 g/10 minutes
(190°C)) by 5 weight %
•The cyclic olefin polymer layer 25: Hydrogenated
norbornene ring-opened polymer (product name "ZEONOR
1020R" manufactured by ZEON Corporation, specific gravity
1.01, glass transition temperature (Tg 105°C)}
•The polyethylene layer 27: Mixed resin of linear
polyethylene (density 0.940 g/cm3, manufactured by Mitsui
Chemicals, Inc., product name "ULTZEX 4020L", MFR 2 .1 g/10
minutes (190*C)) by 75 weight % and high-density
polyethylene (density 0.965 g/cm3, manufactured by Mitsui
Chemicals, Inc., product number "NZ 65150", MFR 16 g/10
minutes (190°C)) by 25 weight %
(3) Manufacture of the medical gas barrier film
The right and back surfaces of the multilayer
substrate film obtained in the above (2) in the state of
being flatly folded (that is, the surface on the side of
the polyethylene layer 27 of the multilayer substrate film
22) and the surface on the side of the alumina deposition
oriented polyester film of the multilayer gas barrier film
obtained in the above (1) (the surface lib on the opposite
side to the deposited layer 13) were laminated via a layer
21 formed of the above-mentioned adhesive according to dry
lamination.
In this manner, a cylindrical medical gas barrier
film having the layer configuration shown in Fig. 1.
(4) Manufacture of a medical bag
One open end 31 of the cylindrical medical gas
barrier film obtained in the above (3) was heat sealed with
a below-mentioned mouth member 34 being sandwiched and the
other open end 32 and a circumferential part 33 of the
multilayer gas barrier film laminated en the surface of
the multilayer substrate film were heat sealed to obtain
a medical bag 30 shown in Fig. 2.
A mouth port 34 formed of polyethylene and having
a layer of ethylene-vinyl alcohol copolymer (EVOH) in the
middle thereof was used as the mouth member. The open ends
31 and 32 and the circumferential part (joint part of the
multilayer gas barrier film laminated on the surface of
the multilayer substrate film) 33 of the medical gas
barrier film were heat sealed at 170°C for 4.5 seconds.
Following preheating at 740"C, the mouth port 34 was fixed
via the medical gas barrier film by heat sealing at 160'C
for 4.5 seconds.
A storage chamber of the medical bag 30 was filled
with distilled water of 500 ml and sealed.
Example 2
(1) Manufacture of a multilayer gas barrier film
A multilayer gas barrier film was prepared in the
same manner as (1) of Example 1.
(2) Manufacture of a multilayer substrate film
A multilayer substrate film was manufactured in the
same way as (2) of Example 1 except that, in place of the
heat sealing layer (thickness of 25 pm) 23 of Example 1,
nixed resin of linear polyethylene (density 0.940 g/cirr,
manufactured by Mitsui Chemicals, Inc., product name
"ULTZEX 4020L", MFR 2.1 g/ 10 minutes (190°C)) by 85
weight % and polypropylene (density 0.910 g/cm3,
nanufactured by Mitsui Chemicals, Inc., product number
"J103WA") by 15 weight % was used as the heat sealing layer.
(3) Manufacture of a medical gas barrier film
A medical gas barrier film was prepared in the same
way as (3) of Example 1 except that the multilayer
substrate film obtained in the above (2) was used as the
multilayer substrate film in place of the film prepared
in Example 1.
(4) Manufacture of a medical bag
One open end 41 of the cylindrical medical gas
barrier film obtained in the above (3) was heat sealed in
the state of sandwiching the same mouth member (mouth port
34) as that used in Example 1, the other open end 42 and
a joint part (circumferential part) 43 of the multilayer
gas barrier film laminated on the surface of the multilayer
substrate film were heat sealed and further a peelable
sealing part 44 was formed in a storage chamber of a medical
bag to obtain a medical bag (multi-chamber bag) 40 shown
in Fig. 4.
The open ends 41 and 42 and the circumferential part
(joint part of the multilayer gas barrier film laminated
on the multilayer substrate film) 43 of the medical gas
barrier film were heat sealed at 170°C for 4.5 seconds and
the peelable sealing part 44 was heat sealed at 130°C for
4.5 seconds. Following preheating at 740°C, the mouth
port was fixed via the medical gas barrier film by heat
sealing at 160"C for 4.5 seconds.
A large storage chamber 45 of the medical bag 40 was
filled with distilled water of 700 ml and a small storage
chamber 46 was filled with distilled water of 300 ml and
the both chambers 45 and 46 were sealed.
Comparative example 1
A medical gas barrier film was manufactured in the
same manner as in Example 1 except that the cyclic olefin
polymer layer 25 is not provided in the multilayer
substrate film 22 of the medical gas barrier film having
the layer configuration shown in Fig. 1. The medical bag
shown in Fig. 2 was manufactured in the same manner as in
Example I except that the medical gas barrier film thus
obtained was used.
Comparative example 2
A medical gas barrier film was manufactured in the
same manner as in Example 1 except that, in the deposition
oriented polyester layer 11 of the multilayer gas barrier
film 10 in the medical gas barrier film having the layer
configuration shown in Fig. 1, the direction of laminating
the oriented polyester film 12 and the deposited layer 13
was reversed. The medical bag shown in Fig. 2 was
manufactured in the same manner as in Example 1 except that
the medical gas barrier film thus obtained was used.
Comparative example 3
A medical gas barrier film was manufactured in the
same manner as in Example 1 except that the polyethylene
layer 17 of the multilayer gas barrier film was not
provided and the thickness of the oriented polyamide layer
was 30 μm in the medical gas barrier film having the layer
configuration shown in Fig. 1. The medical bag shown in
Fig. 2 was manufactured in the same manner as in Example
1 except that the medical gas barrier film thus obtained
was used.

(1) Elution test, etc.
The medical bags obtained in Examples 1 and 2 and
Comparative examples 1 to 3 were subjected to high pressure
steam sterilizing treatment (110°C, 60 minutes) and then
test pieces were cut.
Using the test pieces thus obtained, an "acute
toxicity test", a "sensitization test" and a "hemolysis
test" in conformance with rules of The Japanese
Pharmacopoeia (14th revision), Part 1 "55. Test Methods
for Plastic Containers - 2. Extraction Test" and "55. -7.
Cytotoxicity Test" and The Japanese Pharmacopoeia (14tn
version), Part 2 "13. Plastic Containers for
Pharmaceutical Products " (Guideline on Basic Biological
Tests of Medical Devices and Biomedical Materials, I.
Cytotoxicity Test 10. Cytotoxicity Test Using Medical
Devices and Extraction Liquid of Materials, II.
Sensitization Test and VII. Hemolysis Test) were
performed.
(2) Measurement of transparency, oxygen
transmission rate, etc.
Further, using the test pieces, tests according to
The Japanese Pharmacopoeia (14th revision), Part 1 "55.
Test Methods for Plastic Containers - 4. Transparency
Test" and "55. -5. Water Vapor Permeability" were
performed, and oxygen transmission rate and sterilization
shrinkage rate were measured.
Oxygen transmission rate (cm3/m3/day) was measured
under the conditions of temperature of 20'C and humidity
of 60 %RH using an oxygen transmission rate measuring
device (manufactured by MOCON Inc. (US), model name
"OXTRAN 2/20").
Oxygen transmission rate is preferably 0.2
cm3/m3/day or less, more preferably 1 cm3/m3/day or less.
Sterilization shrinkage rate (%) calculated by
comparing test pieces cut from the medical bag before being
subjected to high pressure steam sterilizing treatment
with the above-mentioned test pieces in length shows the
rate at which the medical gas barrier film is shrunk due
to high pressure steam sterilizing treatment.
Sterilization shrinkage rate is preferably 2.5 % or
less, more preferably 1.0 % or less, in MD and preferably
2.5 % or less, more preferably 1.0 % or less, in TD.
(3) Drop test
15 medical bags obtained in each of Example 1 and
2 and Comparative example 1 to 3 were subjected to high
pressure steam sterilizing treatment (IIO'C, 60 minutes)
and then, five medical bags of each example were stacked
in the state of being horizontally arranged, contained in
an outer housing and stored at 0°C for two days. After
storage, the medical bags were dropped from the height of
120 cm and occurrence of leakage of liquid and presence
or absence of gas and vapor barrier properties reduction
were confirmed.
With respect to gas and vapor barrier properties,
oxygen transmission rate and vapor transmission rate after
the drop test were measured in the same manner as the
above-mentioned manner and when oxygen transmission rate
exceeded 0.2 cm3/m3/day and vapor transmission rate
exceeded 0.27 g/mVday, it was regarded that gas and vapor
barrier properties were deteriorated.
(4) Evaluation results
The medical bags in Examples 1 and 2 satisfied
reference values of all evaluation items in the tests (1) .
On the contrary, in the medical bag in Comparative example
I, elution of substances of the adhesive was found.
It found that the medical bags in Examples 1 and 2
had transparency of 82.5 %, oxygen transmission rate of
0.04 cmVmVday (20°C, 60 %RH) , vapor transmission rate
of 0.18 g/m3/day (40°C, 90 %RH) , and sterilization
shrinkage rate of 1.3 (MD) and -0.3 (TD) , and showed
excellent gas and vapor properties and extremely low
shrinkage rate after sterilization treatment. On the
contrary, it was found that the medical bags in Comparative
examples 2 and 3 had increased oxygen transmission rate
and vapor transmission rate by sterilization treatment and
the medical bags in Comparative example 3 had lowered
transparency by sterilization treatment.
In the medical bags in Examples 1 and 2, even after
the drop test was performed, no leakage of liquid was found
and oxygen transmission rate and vapor transmission rate
hardly changed. On the contrary, in the medical bags in
Comparative example 2 contained in two of three outer
housings, leakage of liquid was generated. Even in the
medical bags generating no leakage of liquid, increase in
oxygen transmission rate and vapor transmission rate was
observed. In the medical bags in Comparative example 3,
drop of flexibility and resulting occurrence of creases
and lines were observed.
The present invention is not limited to the
above-mentioned descriptions and can be variously
modified in design as long as it falls within the scope
of matters stated in claims.
While the present invention has been described by
way of the embodiments thereof, these embodiments are
merely illustrative, but not limitative of the invention.
Variations of the present invention apparent to those
skilled in the art are to fall within the scope of the
present invention defined by the appended claims.
Industrial Applicability
The medical gas barrier film of the present invention
is suitable for a material for medical bags for storing
medicine which is easy to deteriorate due to gas such as
oxygen, vapor and the like in medical applications.
The medical bag of the present invention is suitable
for medical applications, especially for storing medicine
which is easy to deteriorate due to gas such as oxygen,
vapor and the like.

Claims
1. A medical gas barrier film comprising a multilayer
gas barrier film and a multilayer substrate film adhered
to the multilayer gas barrier film, wherein
the multilayer gas barrier film includes a
deposition oriented polyester layer having a deposited
layer of an inorganic oxide on one surface, an oriented
polyamide layer adhered to a surface of the deposited layer
of the deposition oriented polyester layer and a
polyethylene layer adhered to a surface on the opposite
side to an adhered surface of the oriented polyamide layer
to the deposited layer,
the multilayer substrate film includes a cyclic
olef in polymer layer, an elastomer layer and a heat sealing
layer and is adhered to the other surface of the deposition
oriented polyester layer, and
the heat sealing layer is disposed on the surface
on the opposite side to the adhered surface of the
multilayer substrate film to the deposition oriented
polyester layer.
2. A medical gas barrier film as stated in claim 1,
wherein the multilayer substrate film has a cyclic olefin
polymer layer, a first elastomer layer adhered to one
surface of the cyclic olefin polymer layer, a heat sealing
layer on the opposite side to an adhered surface of the
first elastomer layer to the cyclic olefin polymer layer,
a second elastomer layer adhered to the other surface of
the cyclic olefin polymer layer and a polyethylene layer
adhered to a surface on the opposite side to an adhered
surface of the second elastomer layer to the cyclic olefin
polymer layer.
3. A medical gas barrier film as stated in claim 2,
wherein a total thickness of the first elastomer layer and
the second elastomer layer is 55 to 80 % of a thickness
of the multilayer substrate film.
4. A medical gas barrier film as stated in claim 1,
wherein a thickness of the polyethylene layer of the
multilayer gas barrier film is 1 or 2 times larger than
a total thickness of the deposition oriented polyester
layer and the oriented polyamide layer.
5. A medical gas barrier film as stated in claim 1,
wherein the polyethylene layer of the multilayer gas
barrier film is a three-layer film formed of a linear
polyethylene film having a density of 0.910 to 0.930 g/cm3
and high density polyethylene films each having a density
of 0.950 to 0.970 g/cm3 and adhered to both surfaces of
the linear polyethylene layer, and a thickness of each of
the high density polyethylene films is 0.2 to 0.3 time
larger than that of the linear polyethylene film.
6. A medical gas barrier film as stated in claim 1,
wherein the inorganic oxide is alumina.
7. A medical gas barrier film as stated in claim 1,
wherein the multilayer substrate film is a cylindrical
film formed by inflation molding and an innermost layer
of the cylindrical film is the heat sealing layer.
8. Amedicalbag formed by welding a medical gas barrier
film so that heat sealing layers thereof face each other,
wherein
the medical gas barrier film comprises a multilayer
gas barrier film and a multilayer substrate film adhered
to the multilayer gas barrier film,
the multilayer gas barrier film includes a
deposition oriented polyester layer having a deposited
layer of an inorganic oxide on one surface, an oriented
polyamide layer adhered to a surface of the deposited layer
of the deposition oriented polyester layer and a
polyethylene layer adhered to a surface on the opposite
side to an adhered surface of the oriented polyamide layer
to the deposited layer,
the multilayer substrate film includes a cyclic
olef in'polymer layer, an elastomer layer and a heat sealing
layer and is adhered to the other surface of the deposition
oriented polyester layer, and
the heat sealing layer is disposed on a surface on
the opposite side to an adhered surface of the multilayer
substrate film to the deposition oriented polyester layer.
9. A medical bag formed by welding an open end of a
multilayer substrate film in a medical gas barrier film,
wherein
the medical gas barrier film comprises a multilayer
gas barrier film and a multilayer substrate film adhered
to the multilayer gas barrier film,
the multilayer gas barrier film includes a
deposition oriented polyester layer having a deposited
layer of an inorganic oxide on one surface, an oriented
polyamide layer adhered to a surface of the deposited layer
of the deposition oriented polyester layer and a
polyethylene layer adhered to a surface on the opposite
side to an adhered surface of the oriented polyamide layer
to the deposited layer,
the multilayer substrate film is a cylindrical film
formed by inflation molding, includes a cyclic olefin
polymer layer, an elastomer layer and a heat sealing layer
and is adhered to the other surface of the deposition
oriented polyester layer,
the heat sealing layer is disposed on a surface on
the opposite side to an adhered surface of the multilayer
substrate film to the deposition oriented polyester layer,
and
an innermost layer of the cylindrical multilayer
substrate film is the heat sealing layer.
10. Amedical bag as stated in claim 8, the whole of which
is subjected to heating and sterilization after being
filled with a medical fluid and sealed.
11 . A medical bag as stated in claim 9, the whole of which
is subjected to heating and sterilization after being
filled with a medical fluid and sealed.
12. A medical gas barrier film substantially as herein described with
reference to the foregoing description and the accompanying
drawings.
13. A medical bag barrier film substantially as herein described with
reference to the foregoing description and the accompanying
drawings.

Documents:

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Patent Number

270139

Indian Patent Application Number

2663/DELNP/2007

PG Journal Number

49/2015

Publication Date

04-Dec-2015

Grant Date

30-Nov-2015

Date of Filing

10-Apr-2007

Name of Patentee

OTSUKA PHARMACEUTICAL FACTORY, INC.

Applicant Address

115, AZA-KUGUHARA, TATEIWA, MUYA-CHO, NARUTO-SHI, TOKUSHIMA 772-8601, JAPAN

Inventors:

#	Inventor's Name	Inventor's Address
1	MORI HITOSHI	27, KOMATSUNISHI, KAWAUCHI-CHO, TOKUSHIMA-SHI, TOKUSHIMA 771-0104, JAPAN
2	MORIMOTO YASUSHI	23-2, AZA-OTANI, OKUWAJIMA, MUYA-CHO, NARUTO-SHI, TOKUSHIMA 772-0011, JAPAN
3	KONISHI KENJI	512-2, AZA-HIGASHIKAKUEN, AIHATA, ISHII-CHO, MYOZAI-GUN, TOKUSHIMA 779-3212, JAPAN
4	TATEISHI ISAMU	569, OSHIRO, OTSU-CHO, NARUTO-SHI, TOKUSHIMA 772-0041, JAPAN

PCT International Classification Number

B32B 9/04

PCT International Application Number

PCT/JP2005/018834

PCT International Filing date

2005-10-13

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	2004-302987	2004-10-18	Japan