JP2009234044A - Laminated film for medical bag, and medical bag using the same - Google Patents
Laminated film for medical bag, and medical bag using the same Download PDFInfo
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本発明は、医療製袋用積層フィルム及びこれを用いた医療用製袋に関する。 The present invention relates to a laminated film for medical bag making and a medical bag making using the same.
膵臓、腎臓、Ｓ字結腸、腹部大動脈瘤等の手術の際、術野を確保するために小腸等を一時的に保管したり、あるいは臓器提供者から摘出した腎臓あるいは心臓等を臓器受容者のところまで運搬するまで保管したりする際に、アイソレーションバッグと呼ばれる医療用製袋が用いられている。 During surgery of the pancreas, kidney, sigmoid colon, abdominal aortic aneurysm, etc., temporarily store the small intestine, etc. to secure the operative field, or remove the kidney, heart, etc. removed from the organ donor A medical bag called an isolation bag is used when storing until it is transported.
この医療用製袋の材料としては、輸送時、保管時及び使用時の便宜性を考慮し、ポリエチレンやポリプロピレンに代表されるポリオレフィン系の合成樹脂製の袋が使用されることが多く、ポリオレフィン系合成樹脂からなる医療用製袋が数多く提案されている（例えば、特許文献１、２参照）。ここで、保管した臓器の状態を容易に目視観察できるように医療用製袋を形成する素材フィルムに透明性の高い材料である高圧法低密度ポリエチレン系、直鎖状低密度ポリエチレン系、ポリプロピレン系の材料が用いられている。
As a material for this medical bag-making, in consideration of convenience during transportation, storage and use, a polyolefin-based synthetic resin bag represented by polyethylene or polypropylene is often used. Many medical bags made of synthetic resins have been proposed (see, for example,
しかしながら、一般に、高圧法低密度ポリエチレン、直鎖状低密度ポリエチレンは機械的特性、透明性に劣り、ポリプロピレン系は機械的特性に優れるが、柔軟性、製袋性に劣る問題があった。
そこで、これら機械的特性と柔軟性を両立するためにポリプロピレン系と直鎖状低密度ポリエチレン系樹脂を積層する方法（例えば、特許文献３、４参照）やメタロセン系触媒で製造されたポリプロピレン系樹脂を用いる方法（例えば、特許文献５〜７参照）が提案されているが、これらは医療用製袋とした場合、シール強度と外観を両立することが困難であるばかりか、放射線照射によってポリプロピレンが分解することにより機械的特性が低下するとの理由で、放射線滅菌には適さないものであった。
However, in general, high-pressure method low-density polyethylene and linear low-density polyethylene are inferior in mechanical properties and transparency, and polypropylene is excellent in mechanical properties, but has problems of poor flexibility and bag-making properties.
Therefore, in order to achieve both of these mechanical properties and flexibility, a polypropylene-based resin produced by a method of laminating a polypropylene-based and linear low-density polyethylene-based resin (see, for example,
本発明の目的は、上述した従来技術の問題点を解決しようとするものであって、ＥＯＧ滅菌のみならず、放射線滅菌後も高い透明性を有し、機械的特性、柔軟性、製袋性にも優れた医療製袋用積層フィルム並びにこれを用いた医療用製袋を提供するものである。 The object of the present invention is to solve the above-mentioned problems of the prior art, and has high transparency not only by EOG sterilization but also after radiation sterilization, and has mechanical properties, flexibility and bag-making properties. The present invention also provides an excellent laminated film for medical bag making and a medical bag making using the same.
このような目的は、下記（１）〜（５）に記載の本発明により達成される。
（１）共押出により形成された３層構造の積層フィルムであって、
ポリエチレン樹脂を含む外層材と、ポリエチレン樹脂とメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂との混合材を含む中層材と、ポリエチレン樹脂を含む内層材と、から構成され、前記中層材に用いられる前記ポリエチレン樹脂の含有量が、前記混合材全体に対して重量％以上、９５重量％以下であり、且つ前記メタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の含有量が、５重量％以上、５０重量％以下であることを特徴とする医療製袋用積層フィルム。
（２）前記外層材、中層材及び内層材に用いられるポリエチレン樹脂の重量平均分子量（Ｍｗ）と数平均分子量（Ｍｎ）との比（Ｍｗ／Ｍｎ）が３．５以下である（１）に記載の医療製袋用積層フィルム。
（３）前記中層材に用いられるメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の重量平均分子量（Ｍｗ）と数平均分子量（Ｍｎ）との比（Ｍｗ／Ｍｎ）が３．０以下である（１）に記載の医療製袋用積層フィルム。
（４）（１）乃至（３）のいずれかに記載の医療製袋用積層フィルムをヒートシールし、該ヒートシールされた所定の形状に沿って前記積層フィルムを裁断若しくは打ち抜いて形成されてなるシート本体から構成されることを特徴とする医療用製袋。
（５）放射線で滅菌してなる（４）記載の医療用製袋。
Such an object is achieved by the present invention described in the following (1) to (5).
(1) A laminated film having a three-layer structure formed by coextrusion,
The intermediate layer material comprising: an outer layer material including a polyethylene resin; an intermediate layer material including a mixture of a polyethylene resin and a linear ultra-low density polyethylene resin polymerized by a metallocene catalyst; and an inner layer material including a polyethylene resin. The content of the polyethylene resin used in the above is not less than 95% by weight and not more than 95% by weight with respect to the whole mixed material, and the content of the linear ultra-low density polyethylene resin polymerized by the metallocene catalyst, A laminated film for medical bag making, characterized by being 5 wt% or more and 50 wt% or less.
(2) The ratio (Mw / Mn) of the weight average molecular weight (Mw) and the number average molecular weight (Mn) of the polyethylene resin used for the outer layer material, the middle layer material and the inner layer material is 3.5 or less. The laminated film for medical bag making described.
(3) The ratio (Mw / Mn) of the weight average molecular weight (Mw) to the number average molecular weight (Mn) of the linear ultra-low density polyethylene resin polymerized by the metallocene catalyst used for the intermediate layer material is 3.0 or less. The laminated film for medical bag making according to (1).
(4) The laminated film for medical bag making according to any one of (1) to (3) is heat-sealed, and the laminated film is cut or punched along the heat-sealed predetermined shape. A medical bag making comprising a sheet body.
(5) The medical bag-making according to (4), which is sterilized by radiation.
本発明によれば、ＥＯＧ滅菌のみならず、放射線滅菌後も高い透明性を有し、機械的特性、柔軟性、製袋性にも優れた医療製袋用積層フィルム並びにこれを用いた医療用製袋を得ることができる。 According to the present invention, not only EOG sterilization but also high transparency after radiation sterilization and excellent mechanical properties, flexibility, and bag-making properties, laminated films for medical bag making, and medical use using the same Bag making can be obtained.
以下、本発明を実施するための最良の形態について、図面を参照しつつ説明する。
図１は、本発明に係る医療製袋用積層フィルムの第一実施形態を示す概略斜視図である。
The best mode for carrying out the present invention will be described below with reference to the drawings.
FIG. 1 is a schematic perspective view showing a first embodiment of a laminated film for medical bag making according to the present invention.
第一実施形態に係る医療製袋用積層フィルム（以下、単に「積層フィルム」ということがある）は、ポリエチレン樹脂を含む外層材と、ポリエチレン樹脂とメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂との混合材を含む中層材と、ポリエチレン樹脂を含む内層材と、から構成される。即ち、本発明の積層フィルムは、円内の拡大断面図に示すように３層構造を有する。 The laminated film for medical bag making according to the first embodiment (hereinafter sometimes simply referred to as “laminated film”) is a linear ultra-low density polymerized by an outer layer material containing a polyethylene resin, a polyethylene resin and a metallocene catalyst. It is comprised from the intermediate | middle layer material containing the mixed material with a polyethylene resin, and the inner layer material containing a polyethylene resin. That is, the laminated film of the present invention has a three-layer structure as shown in an enlarged sectional view in a circle.
本発明の積層フィルム（１）の外層材（２）、内層材（４）に用いるポリエチレン樹脂及び中層材（３）に用いる１成分であるポリエチレン樹脂は、低密度ポリエチレン樹脂を用いるのが好ましい。低密度ポリエチレンを用いることで透明性の優れた積層フィルムを得ることが出来る。 As the polyethylene resin used as the outer layer material (2) and inner layer material (4) of the laminated film (1) of the present invention and the polyethylene resin as one component used in the middle layer material (3), it is preferable to use a low density polyethylene resin. By using low density polyethylene, a laminated film having excellent transparency can be obtained.
また、上記ポリエチレン樹脂の重量平均分子量（Ｍｗ）と数平均分子量（Ｍｎ）との比（Ｍｗ／Ｍｎ）が３．５以下であるグレードが好ましい。上記比の分子量範囲が狭いグレードのポリエチレン樹脂を用いることで機械的強度の優れた積層フィルムを得ることが出来る。このようなポリエチレン樹脂の例としては、直鎖型低密度ポリエチレン樹脂があげられる。また、３層構造の外層材（２）、内層材（４）に用いるポリエチレン樹脂及び中層材（３）に用いる１成分であるポリエチレン樹脂は、同一グレードであっても違うグレードでも良いが、性能に問題のない限り、装置、製法が簡略化できるので、経済的観点から３成分はいずれも同じグレードを用いることが好ましい。 Moreover, the grade whose ratio (Mw / Mn) of the weight average molecular weight (Mw) and number average molecular weight (Mn) of the said polyethylene resin is 3.5 or less is preferable. A laminated film having excellent mechanical strength can be obtained by using a grade of polyethylene resin having a narrow molecular weight range. Examples of such polyethylene resins include linear low density polyethylene resins. In addition, the polyethylene resin used for the outer layer material (2) and the inner layer material (4) of the three-layer structure and the polyethylene resin as one component used for the middle layer material (3) may be the same grade or different grades. As long as there is no problem, the apparatus and the manufacturing method can be simplified, so it is preferable to use the same grade for all three components from the economical viewpoint.
このような外層材（２）、中層材（３）と内層材（４）を備えた本発明の積層フィルム（１）を共押出しする方法は、特に限定されず、Ｔダイによる共押出成形、インフレーション成形、水冷インフレーション法のいずれであってもよい。ここで、ポリエチレン樹脂とメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂との混合材を含む中層材（３）は、予め所定の成分を溶融混練し、ペレット化したものを使用してもいいし、押出成形時に定量フィーダー等で所定の割合で各成分を供給してもいい。 The method of co-extrusion of the laminated film (1) of the present invention provided with such outer layer material (2), middle layer material (3) and inner layer material (4) is not particularly limited, Either an inflation molding or a water-cooled inflation method may be used. Here, the intermediate layer material (3) containing a mixture of a polyethylene resin and a linear ultra-low density polyethylene resin polymerized with a metallocene catalyst is prepared by previously kneading and pelletizing predetermined components. Alternatively, each component may be supplied at a predetermined ratio with a quantitative feeder or the like at the time of extrusion molding.
この中層材（３）の厚みは、材質等に応じて適宜設定することができるが、好ましくは４０μｍ以上、３００μｍ以下、より好ましくは６０μｍ以上、１５０μｍ以下である。厚みを上記範囲とすることで透明性、柔軟性と強度に優れる積層フィルムが得られる。 The thickness of the intermediate layer material (3) can be appropriately set according to the material and the like, but is preferably 40 μm or more and 300 μm or less, more preferably 60 μm or more and 150 μm or less. By setting the thickness within the above range, a laminated film having excellent transparency, flexibility and strength can be obtained.
本発明の積層フィルム（１）においては、後述する如くメタロセン触媒により重合された超低密度ポリエチレン樹脂を用いることによって、従来のポリエチレン樹脂を用いたフィルムに比べて高い強度が得られるため、例えば、従来２００〜３００μｍ程度の厚みが強度上要求されるフィルムを１００μｍ程度にまで薄くすることが可能である。 In the laminated film (1) of the present invention, by using an ultra-low density polyethylene resin polymerized with a metallocene catalyst as described later, a higher strength can be obtained than a film using a conventional polyethylene resin. Conventionally, it is possible to thin a film that requires a strength of about 200 to 300 μm in strength to about 100 μm.
本発明の積層フィルムの中層材（３）に用いられる前記ポリエチレン樹脂の含有量は、前記混合材全体に対して５０重量％以上、９５重量％以下であり、且つ前記メタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の含有量が、５重量％以上、５０重量％以下であることを特徴とする。更に好ましくはポリエチレン樹脂の含有量は、６０重量％以上、８０重量％以下、前記メタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の含有量が２０重量％以上、６０重量％以下である。
上記ポリエチレン樹脂及び直鎖状超低密度ポリエチレンの含有量を上記範囲とすることで、中層材（３）は高い透明性を有しながら、剛性、機械的特性も得られる。この効果が得られる理由としては、メタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂は、通常の直鎖状低密度ポリエチレンに比べ、分子量、コモノマーの分布が均一であるとされ、上記ポリエチレン樹脂との相乗効果によって得られるものと推測される。
ここでメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の含有量が上記下限値未満の場合は透明性、柔軟性が不十分となり、上記上限値を超えると成形性が悪くなるのみならず、機械的特性、剛性が不十分となる場合がある。
The content of the polyethylene resin used for the middle layer material (3) of the laminated film of the present invention is 50% by weight or more and 95% by weight or less with respect to the whole mixed material, and the content of the polymer directly polymerized by the metallocene catalyst. The content of the chain ultra-low density polyethylene resin is 5% by weight or more and 50% by weight or less. More preferably, the content of the polyethylene resin is 60% by weight or more and 80% by weight or less, and the content of the linear ultra-low density polyethylene resin polymerized by the metallocene catalyst is 20% by weight or more and 60% by weight or less. .
By setting the content of the polyethylene resin and the linear ultra-low density polyethylene in the above range, the intermediate layer material (3) can obtain rigidity and mechanical properties while having high transparency. The reason why this effect can be obtained is that the linear ultra-low density polyethylene resin polymerized by the metallocene catalyst has a uniform molecular weight and comonomer distribution compared to the normal linear low density polyethylene. It is presumed to be obtained by a synergistic effect with the resin.
Here, if the content of the linear ultra-low density polyethylene resin polymerized by the metallocene catalyst is less than the lower limit, transparency and flexibility are insufficient, and if the upper limit is exceeded, moldability only deteriorates. However, the mechanical properties and rigidity may be insufficient.
本発明の積層フィルム（１）の内層材（４）を形成する１成分であるメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の重量平均分子量（Ｍｗ）と数平均分子量（Ｍｎ）との比（Ｍｗ／Ｍｎ）が３．０以下であることが好ましく、より好ましくは２．８以下である。 Weight average molecular weight (Mw) and number average molecular weight (Mn) of a linear ultra-low density polyethylene resin polymerized by a metallocene catalyst that is one component forming the inner layer material (4) of the laminated film (1) of the present invention The ratio (Mw / Mn) is preferably 3.0 or less, more preferably 2.8 or less.
また、外層材（２）、中層材（３）および内層材（４）には、それぞれ必要な特性が保持される限り、各種安定剤、無機充填材あるいは各種樹脂を含有してもよいことは言及するまでもない。 In addition, the outer layer material (2), the middle layer material (3), and the inner layer material (4) may contain various stabilizers, inorganic fillers, or various resins as long as necessary characteristics are maintained. Needless to say.
３層構造フィルムの外層材（２）と中層材（３）と内層材（４）の厚みの比率は、外層材（２）を１としたときに中層材（３）が２以上、５以下、内層材（４）が１以上、２以下であることが好ましい。それぞれの比率を上記範囲内にすることにより、透明性を保ちながら柔軟性、機械的特性、製袋性良好なフィルムを得ることが出来ると共にスリット加工等の公知の方法で所定の寸法にすることが容易にできる。 The ratio of the thicknesses of the outer layer material (2), the middle layer material (3), and the inner layer material (4) of the three-layer structure film is such that when the outer layer material (2) is 1, the middle layer material (3) is 2 or more and 5 or less. The inner layer material (4) is preferably 1 or more and 2 or less. By making each ratio within the above range, it is possible to obtain a film having good flexibility, mechanical properties and bag-making property while maintaining transparency, and to make a predetermined size by a known method such as slit processing. Can be easily done.
以上が本発明に係る医療容器用積層フィルム（１）の構成及び製造方法であり、本発明に係る医療用製袋は上記した本発明の積層フィルム（１）を使用して製造される。
すなわち、本発明の医療用製袋は、上記本発明の医療製袋用積層フィルム（１）を用いて、所定の形状に上記積層フィルム（１）をヒートシールし、該ヒートシールされた所定の形状に沿って前記積層フィルム（１）を裁断若しくは打ち抜いて形成されてなるシート本体から構成されることを特徴とする。この積層フィルム（１）の内層材（３）同士を図２のように中心で折り曲げて、密着させて所定の輪郭形状、即ち所望の袋外形に合わせてヒートシールした後、該ヒートシール部（５）に沿って前記積層フィルム（１）を裁断するか若しくは打ち抜くことによって図３のような製袋が製造される。
The above is a structure and manufacturing method of the laminated film (1) for medical containers which concerns on this invention, and the medical bag making which concerns on this invention is manufactured using the above-mentioned laminated film (1) of this invention.
That is, the medical bag-making of the present invention uses the laminated film for medical bag-making (1) of the present invention to heat-seal the laminated film (1) into a predetermined shape, and the heat-sealed predetermined film It is characterized by comprising a sheet body formed by cutting or punching the laminated film (1) along its shape. The inner layer materials (3) of the laminated film (1) are bent at the center as shown in FIG. 2 and brought into close contact with each other and heat-sealed in accordance with a predetermined contour shape, that is, a desired bag outer shape. By cutting or punching the laminated film (1) along 5), a bag making as shown in FIG. 3 is manufactured.
本発明の医療用製袋は必要に応じて、図４のように所定箇所に、医療用製袋の開口部を閉じるための口ひも（６）、あるいはガーゼやゴムシートからなる滑り止め（７）を設置することができる。口ひも（６）を設置する場合は、口ひも（６）を通す箇所にあわせて積層フィルム（１）の外層材（２）同士をヒートシールする。このときひもに止め具（８）を付設しておくと、鉗子などで口ひもを止める必要がなくなる。 If necessary, the medical bag according to the present invention has a strap (6) for closing the opening of the medical bag at a predetermined position as shown in FIG. 4, or a slip stopper (7) made of gauze or a rubber sheet. ) Can be installed. When installing the lacing (6), the outer layer materials (2) of the laminated film (1) are heat-sealed to match the location where the lacing (6) is passed. At this time, if the stopper (8) is attached to the string, it is not necessary to stop the lace with forceps or the like.
通常、医療用製袋は通常滅菌を実施して、医療現場に提供される。
本発明の医療用製袋の滅菌方法としては、例えばエチレンガス滅菌、放射線滅菌を用いることができる。放射線滅菌の場合は、ＥＯガスを使用することがないために、アレルギー源とされる残留ＥＯの蒸散を待つまでなく（通常１週間程度の蒸散期間が必要とされる。）、直ちに医療現場に提供することができるので好ましい。
Usually, medical bags are usually sterilized and provided to the medical site.
Examples of the method for sterilizing a medical bag according to the present invention include ethylene gas sterilization and radiation sterilization. In the case of radiation sterilization, since EO gas is not used, there is no need to wait for evaporation of residual EO, which is a source of allergies (usually a transpiration period of about one week is required). Since it can provide, it is preferable.
放射線滅菌としては、γ線、電子線が一般的に用いられる。特に医療用製袋の滅菌では厚みが薄く、透過力がさほど必要ないことを考慮すると、処理時間が短くて済むこと及び空気中で滅菌処理ができるという観点から、電子線が好適である。その照射条件は、制限されるものではないが、総線量として５〜８０ｋＧｙが好ましく、更に好ましくは１０〜６０ｋＧｙである。放射線の総線量を上記範囲とすることで、十分な滅菌が可能であり、且つ製袋の柔軟性を保ちながら黄変を防止できる。 For radiation sterilization, γ rays and electron beams are generally used. In view of the fact that the thickness of the bag for sterilization of medical bags is particularly small and the permeation power is not necessary, an electron beam is preferable from the viewpoint of shortening the processing time and enabling sterilization in the air. Although the irradiation conditions are not limited, the total dose is preferably 5 to 80 kGy, more preferably 10 to 60 kGy. By setting the total dose of radiation within the above range, sufficient sterilization is possible, and yellowing can be prevented while maintaining the flexibility of the bag making.
以下、本発明に係る実施例及び比較例を示すことによって、本発明の効果をより明確なものとする。但し、本発明は以下の実施例により何ら限定されるものではない。 Hereinafter, the effects of the present invention will be made clearer by showing examples and comparative examples according to the present invention. However, the present invention is not limited to the following examples.
（実施例１）
３台の４０ｍｍφフィルム成形機（池貝社製 ＦＳ４０）にて、４００ｍｍ幅の３層共押出Ｔ字型ダイスを用い常法により、外層材に低密度ポリエチレン樹脂（ＭＦＲ１．０、密度０．９２０ｇ／ｃｍ３ Ｍｗ／Ｍｎが３．４）（以下、ＰＥ−１と略）、中層材がＰＥ−１とメタロセン触媒で重合されたＬ−ＬＤＰＥ（ＭＦＲ３．８、密度０．９０３ｇ／ｃｍ３ Ｍｗ／Ｍｎが２．８）（以下、「ＰＥ−２」と略す）を６０：４０の比率で混合したものであり、内層材はＰＥ−１である三層積層フィルムを製造した。
成形温度は１８５℃であり、厚み８０μｍ、幅３８０ｍｍ、各層材の厚み比を外層材：中層材：内層材＝１：５：１とした積層フィルムを得た。
Example 1
With three 40 mmφ film forming machines (FS40 manufactured by Ikegai Co., Ltd.), a low-density polyethylene resin (MFR1.0, density 0.920 g / density) is used for the outer layer material by a conventional method using a 400-mm-width three-layer coextrusion T-shaped die cm3 Mw / Mn is 3.4) (hereinafter abbreviated as PE-1), L-LDPE (MFR 3.8, density 0.903 g / cm3 Mw / Mn is polymerized with PE-1 and a metallocene catalyst as an intermediate layer material) 2.8) (hereinafter, abbreviated as “PE-2”) was mixed at a ratio of 60:40, and a three-layer laminated film was produced in which the inner layer material was PE-1.
The molding temperature was 185 ° C., and a laminated film having a thickness of 80 μm, a width of 380 mm, and a thickness ratio of each layer material of outer layer material: middle layer material: inner layer material = 1: 5: 1 was obtained.
（実施例２）
実施例１において、中層材のＰＥ−１とＰＥ−２との比率を８０：２０の比率で混合し、成形温度は１８５℃であり、厚み８０μｍ、幅３８０ｍｍ、各層の厚み比を外層材：中層材：内層材＝１：２：２とした以外は実施例１と同様にして積層フィルムを得た。
(Example 2)
In Example 1, the ratio of PE-1 and PE-2 of the middle layer material was mixed at a ratio of 80:20, the molding temperature was 185 ° C., the thickness was 80 μm, the width was 380 mm, and the thickness ratio of each layer was the outer layer material: A laminated film was obtained in the same manner as in Example 1 except that the intermediate layer material: inner layer material = 1: 2: 2.
（比較例１）
実施例１において、中層材をＰＥ−１のみから形成した以外は実施例１と同様にして積層フィルムを得た。
(Comparative Example 1)
In Example 1, a laminated film was obtained in the same manner as in Example 1 except that the middle layer material was formed only from PE-1.
（比較例２）
実施例１において、中層材をＰＥ−１とＰＥ−２を６０：４０の比率で混合したもので形成した以外は実施例１と同様にして積層フィルムを得た。
(Comparative Example 2)
In Example 1, a laminated film was obtained in the same manner as in Example 1 except that the middle layer material was formed by mixing PE-1 and PE-2 at a ratio of 60:40.
（比較例３）
実施例１において、中層材をチーグラー触媒で重合されたＬ−ＬＤＰＥ（ＭＦＲ２、０ 密度０．９００ｇ／ｃｍ３ Ｍｗ／Ｍｎ３．３）とＰＥ−１を８０：２０の比率で混合したもので形成した以外は実施例１と同様にして積層フィルムを得た。
(Comparative Example 3)
In Example 1, the middle layer material was formed by mixing L-LDPE (MFR2, 0 density 0.900 g / cm3 Mw / Mn3.3) polymerized with a Ziegler catalyst at a ratio of 80:20. A laminated film was obtained in the same manner as Example 1 except for the above.
（比較例４）
実施例１において、チーグラー触媒で重合されたランダムＰＰ（ＭＦＲ４．０、密度０．９００ｇ／ｃｍ３ Ｍｗ／Ｍｎ３．４）とＰＥ−１を８０：２０の比率で混合したもので形成した以外は実施例１と同様にして積層フィルムを得た。
(Comparative Example 4)
In Example 1, except that it was formed by mixing random PP (MFR 4.0, density 0.900 g /
実施例及び比較例で得られたフィルムについて特性を評価した。
評価方法は次のとおりである。
The characteristics of the films obtained in Examples and Comparative Examples were evaluated.
The evaluation method is as follows.
（１）透明性：ＪＩＳ Ｋ７１０５に準拠してヘイズ値を測定した。 (1) Transparency: The haze value was measured according to JIS K7105.
（２）柔軟性：ＪＩＳ Ｚ１７０２に準拠して、引張弾性率を測定した。 (2) Flexibility: The tensile elastic modulus was measured according to JIS Z1702.
（３）破断強度：ＪＩＳ Ｚ１７０２に準拠して、引張破断強度を測定した。 (3) Breaking strength: The tensile breaking strength was measured according to JIS Z1702.
（４）シール強度：得られたフィルム内層を重ね合せ、ヒートシールを行い（条件：シール温度１８０℃、シール時間１．２秒、シール圧力０．８ＭＰａ）、シール部を巾１５ｍｍで切り出してシール強度を測定した。 (4) Seal strength: The obtained film inner layers are overlapped and heat sealed (conditions: seal temperature 180 ° C., seal time 1.2 seconds, seal pressure 0.8 MPa), and the seal portion is cut out with a width of 15 mm and sealed. The strength was measured.
（５）耐放射線劣化性：加速電圧２００ＫｅＶで総量４０ＫＧｙの線量で処理した後に、ＩＳＯ１１７３７放射線滅菌に記載された、劣化加速試験方法（６０℃×７日間）で処理した後に、再度ＪＩＳ Ｚ１７０２に準拠し、破断強度を測定した。
結果を表１に示す
(5) Radiation resistance: after treatment with an acceleration voltage of 200 KeV and a dose of 40 KGy, and after treatment with the accelerated degradation test method (60 ° C. × 7 days) described in ISO 11737 radiation sterilization, conforms to JIS Z1702 again. Then, the breaking strength was measured.
The results are shown in Table 1.
表１に示すように、本発明の積層フィルムを用いた実施例１、２は、透明性及び柔軟性、破断強度の機械的特性及び製袋時のヒートシール強度、及び耐放射線劣化性に優れており、医療用製袋用フィルムに要求される透明性、柔軟性、機械的強度、製袋性（シール強度）の全ての評価項目で優れた特性を有していた。また、耐放射線劣化性にも優れているので、放射線滅菌が可能であることが示された。
これに対して、本発明の積層フィルムを用いない比較例１〜４では、医療用製袋用フィルムに要求される透明性、柔軟性、機械的強度、製袋性（シール強度）の全ての評価項目を満たし、かつ耐放射線劣化性に優れたものは無かった。
具体的には、中層材が低密度ポリエチレン樹脂のみから構成されている比較例１では透明性及び柔軟性が低く、中層材のメタロセン触媒で重合されたＬ−ＬＤＰＥの比率を請求項の範囲より多くした比較例２では成形性が悪くなり、中層材が平滑でなくなるために、積層フィルムのヘイズが悪くなった。中層材を形成する成分をチーグラー触媒で重合されたＬ−ＬＤＰＥに置き換えた比較例３では破断強度が低かった。また、中層材を形成する成分をチーグラー触媒で重合されたランダムＰＰに置き換えた比較例４では、放射線照射前の特性は優れるが、耐放射線劣化性に劣っていた。
As shown in Table 1, Examples 1 and 2 using the laminated film of the present invention are excellent in transparency and flexibility, mechanical properties of breaking strength, heat seal strength during bag making, and radiation resistance. Therefore, it had excellent characteristics in all evaluation items of transparency, flexibility, mechanical strength, and bag-making property (seal strength) required for medical bag-making films. It was also shown that radiation sterilization is possible because of its excellent resistance to radiation degradation.
On the other hand, in Comparative Examples 1 to 4 that do not use the laminated film of the present invention, all of the transparency, flexibility, mechanical strength, and bag-making property (seal strength) required for the medical bag-making film are used. None of them satisfied the evaluation items and were excellent in radiation resistance.
Specifically, in Comparative Example 1 in which the middle layer material is composed only of the low density polyethylene resin, the transparency and flexibility are low, and the ratio of L-LDPE polymerized with the metallocene catalyst of the middle layer material is from the scope of the claims. In the comparative example 2 which increased, since the moldability deteriorated and the intermediate layer material became not smooth, the haze of the laminated film was deteriorated. In Comparative Example 3 in which the component forming the middle layer material was replaced with L-LDPE polymerized with a Ziegler catalyst, the breaking strength was low. Moreover, in the comparative example 4 which replaced the component which forms an intermediate | middle layer material with the random PP polymerized with the Ziegler catalyst, although the characteristic before radiation irradiation was excellent, it was inferior to radiation degradation resistance.
１ 積層フィルム
２ 外層材
３ 中層材
４ 内層材
５ ヒートシール部
６ 口ひも
７ 滑り止め
８ 止め具
DESCRIPTION OF
Claims (5)
ポリエチレン樹脂を含む外層材と、ポリエチレン樹脂とメタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂との混合材を含む中層材と、ポリエチレン樹脂を含む内層材とから構成され、前記中層材に用いられる前記ポリエチレン樹脂の含有量が、前記混合材全体に対して５０重量％以上、９５重量％以下であり、且つ前記メタロセン触媒により重合された直鎖状超低密度ポリエチレン樹脂の含有量が、５重量％以上、５０重量％以下であることを特徴とする医療製袋用積層フィルム。 A laminated film having a three-layer structure formed by coextrusion,
It is composed of an outer layer material containing a polyethylene resin, an intermediate layer material containing a mixture of a polyethylene resin and a linear ultra-low density polyethylene resin polymerized by a metallocene catalyst, and an inner layer material containing a polyethylene resin. The content of the polyethylene resin used is 50% by weight or more and 95% by weight or less with respect to the entire mixed material, and the content of the linear ultra-low density polyethylene resin polymerized by the metallocene catalyst is A laminated film for medical bag making, characterized by being 5 wt% or more and 50 wt% or less.
The medical bag-making according to claim 4, which is sterilized by radiation.
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| JP2005324468A (en) * | 2004-05-14 | 2005-11-24 | Idemitsu Unitech Co Ltd | Multi-layer film for heat lamination, multi-layer film-laminated metallic plate and method for manufacturing multi-layer film-laminated metallic plate |
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Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0947486A (en) * | 1995-05-30 | 1997-02-18 | Tosoh Corp | Laminated body and medical bag |
| JPH11119382A (en) * | 1997-10-09 | 1999-04-30 | Fuji Photo Film Co Ltd | Container for photographic film |
| JP2001239631A (en) * | 1999-12-22 | 2001-09-04 | Showa Denko Kk | Laminate and medical container |
| JP2001225426A (en) * | 2000-02-15 | 2001-08-21 | Japan Polyolefins Co Ltd | Laminate, method of manufacturing the same, and molded object |
| JP2002136572A (en) * | 2000-08-21 | 2002-05-14 | Kawasumi Lab Inc | Medical instrument |
| JP2003342429A (en) * | 2002-03-18 | 2003-12-03 | Sumitomo Chem Co Ltd | Polypropylene resin composition and its application |
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