JP2009039210A - Medical container package bag and method of storing medical container using the same, medicament-coinjected medical container package body and method of manufacturing medicament uncoinjected medical container package body, and medicament uncoinjected medical container package body - Google Patents

Medical container package bag and method of storing medical container using the same, medicament-coinjected medical container package body and method of manufacturing medicament uncoinjected medical container package body, and medicament uncoinjected medical container package body Download PDF

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JP2009039210A
JP2009039210A JP2007205572A JP2007205572A JP2009039210A JP 2009039210 A JP2009039210 A JP 2009039210A JP 2007205572 A JP2007205572 A JP 2007205572A JP 2007205572 A JP2007205572 A JP 2007205572A JP 2009039210 A JP2009039210 A JP 2009039210A
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medical container
packaging bag
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sealing
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JP5101205B2 (en
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Toshiharu Iwasaki
年晴 岩崎
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Hosokawa Yoko KK
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical container package bag easily discharging air inside, preventing inflow of air and preventing alteration of a solvent coinjected into a medical container without using an exclusive device or instrument such as a vacuum machine; a method of storing the medical container using the same; a medicament-coinjected medical container package body and a method of manufacturing a medicament uncoinjected medical container package body; and a medicament uncoinjected medical container package body. <P>SOLUTION: The medical container package bag 10 formed with a gas barrier film for wrapping the medical container comprises a sealing means 12 which can be reopened, and a check valve mechanism 13 which discharges air from inside the medical container package bag 10 to the outside and which prevents inflow of air from the outside to the inside. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は、医療用容器包装袋、およびこれを用いた医療用容器の収容方法、薬剤混注済み医療用容器包装体、薬剤未混注の医療用容器包装体の製造方法、ならびに薬剤未混注の医療用容器包装体に関する。   The present invention relates to a medical container packaging bag, a method for containing a medical container using the same, a medical container package with a medicine mixed, a method for manufacturing a medical container packaging with no medicine mixed, and a medicine with no medicine mixed The present invention relates to a container package.

医療分野で使用される医療用容器としては、例えば図11に示すようなフィルムを製袋してなる袋状のいわゆる輸液バッグ70、ブロー成形で製造された医療用容器、アンプル、薬剤入りシリンジ、ボトルなどがある。
例えば薬剤入りの輸液バッグは、病院等に納入される迄の流通段階において、酸素や紫外線の透過を防止して内容物(薬剤)の変質を抑制し品質を保持したり、衛生性を確保したり、容器の傷などの機械的損傷を防止したりする目的で、通常、専用の包装袋に包装され搬送される。
As a medical container used in the medical field, for example, a bag-shaped infusion bag 70 formed by making a film as shown in FIG. 11, a medical container manufactured by blow molding, an ampule, a syringe with a medicine, There are bottles.
For example, infusion bags containing medicines prevent the transmission of oxygen and ultraviolet rays in the distribution stage until they are delivered to hospitals, etc., to suppress the deterioration of the contents (drugs) and maintain the quality, and to ensure hygiene. Or, for the purpose of preventing mechanical damage such as scratches on the container, it is usually packed and transported in a dedicated packaging bag.

病院等に搬送された輸液バッグは、包装袋から取り出された後、患者へ投与する前に、患者の病態に応じて他の薬剤を輸液バッグ内に投入したり、または複室輸液バッグの複室の薬剤を混合したりするなど、いわゆる混注操作が行われる場合が多い。混注操作を効率良く、かつ迅速に行ったり、在宅医療用に予め病院で混注された輸液バッグを準備したりするため、病院では輸液バッグを使用する直前よりも前の段階で薬剤を混注し、薬剤が混注された状態で輸液バッグを冷蔵庫等で保管することもある。   After the infusion bag transported to a hospital or the like is taken out of the packaging bag and before administration to the patient, another drug is put into the infusion bag according to the patient's pathology, or the infusion bag of the multi-chamber infusion bag is used. In many cases, so-called mixed injection operations such as mixing medicines in a room are performed. In order to perform mixed injection operation efficiently and quickly, or to prepare an infusion bag pre-mixed in the hospital for home medical care, the hospital mixes the drug at a stage before immediately before using the infusion bag, The infusion bag may be stored in a refrigerator or the like with the medicine mixed.

通常、輸液バッグはガスバリア性に乏しいポリオレフィン樹脂からなるので、酸素などが輸液バッグを通過しやすい。酸素などが容器内に侵入すると、混注後の薬剤が劣化することがあった。
一般に、病院等に納入される迄の流通段階で用いられる上述の包装袋(薬剤未混注の輸液バッグの包装袋)は、バリア性を有さないものも多い。
従って、薬剤混注済み輸液バッグの保管方法としては、ガスバリア性を有する新たな包装袋を用意し、この包装袋に薬剤混注済み輸液バッグを投入し包装袋の中の空気を抜いてヒートシールして密封する方法が一般的である。さらに、より安定した保管状態を維持するため、真空包装シール機を用いて包装袋内を脱気後、ヒートシールにより密封して保管されることもある。
Usually, an infusion bag is made of a polyolefin resin having poor gas barrier properties, so oxygen and the like easily pass through the infusion bag. When oxygen or the like enters the container, the drug after mixed injection may be deteriorated.
In general, the above-described packaging bags (packaging bags for non-drug-infusion infusion bags) used in the distribution stage before being delivered to a hospital or the like often have no barrier property.
Therefore, as a method of storing the infusion bag with the drug mixed injection, prepare a new packaging bag with gas barrier properties, put the infusion bag with the drug mixed injection into this packaging bag, evacuate the air in the packaging bag and heat seal it. The method of sealing is common. Furthermore, in order to maintain a more stable storage state, the inside of the packaging bag may be deaerated using a vacuum packaging sealing machine and then sealed and stored by heat sealing.

このように、薬剤入りの輸液バッグを搬送し、他の薬剤を混注した輸液バッグを保管するためには、各用途に応じた包装袋をその都度用意する必要があった。
近年では、輸液バッグの搬送と保管の用途に対応した包装袋が提案されている。例えば特許文献1には、開封される側の端部面域が開封方向に平行な向きの直線引裂き性を有し、直線状の切り口を有する開封口の端縁部を封止代として再封止できる包装体が開示されている。該包装体は、再封止性が改善されているため、薬剤入りの輸液バッグの搬送時に用いた後、一旦開封して他の薬剤を輸液バッグに混注し、再度薬剤混注済み輸液バッグを収容して保管することができる。
特開2004−121649号公報
Thus, in order to transport an infusion bag containing a medicine and store an infusion bag mixed with other medicines, it is necessary to prepare a packaging bag for each application.
In recent years, a packaging bag corresponding to the purpose of transporting and storing an infusion bag has been proposed. For example, in Patent Document 1, the end surface area on the side to be opened has a linear tearing property in a direction parallel to the opening direction, and the end edge portion of the opening having a straight cut is used as a sealing allowance. A package that can be stopped is disclosed. Since the package has improved resealability, it is used when transporting a drug-containing infusion bag, then opened once, and other drugs are mixed and infused into the infusion bag. Can be stored.
JP 2004-121649 A

医療用容器に混注される薬剤は、空気中の酸素などの影響を受けやすく、変質しやすい。そのため、薬剤混注済み医療用容器の保管には、該医療用容器を包装する包装袋内の空気が残存しないように、かつ包装袋内に空気が流入しないように細心の注意を払う必要がある。
しかしながら、特許文献1に記載されたような従来の包装袋では、該包装袋内に空気が残存しやすく、特に混注された薬剤の変質を抑制することは必ずしも十分ではなかった。包装袋内に残存する空気量を低減し薬剤の変質を抑制するためには、真空機などを用いて包装袋内を脱気し、真空包装した後にヒートシール等により再封止する必要があり、作業性が低下しやすかった。
Drugs mixed in medical containers are easily affected by oxygen in the air and easily deteriorated. Therefore, it is necessary to pay close attention to the storage of the medical container mixed with medicine so that the air in the packaging bag for packaging the medical container does not remain and the air does not flow into the packaging bag. .
However, in the conventional packaging bag as described in Patent Document 1, air tends to remain in the packaging bag, and it is not always sufficient to suppress the deterioration of the mixed medicine in particular. In order to reduce the amount of air remaining in the packaging bag and suppress the deterioration of the drug, it is necessary to deaerate the inside of the packaging bag using a vacuum machine, etc., and then reseal it by heat sealing etc. The workability was easy to decrease.

本発明は、かかる状況に鑑みてなされたものであり、真空機などの専用の装置や器具を用いなくとも、内部の空気を容易に排出し、かつ空気の流入を防止し、医療用容器に混注された溶剤の変質を抑制できる医療用容器包装袋、およびこれを用いた医療用容器の収容方法、薬剤混注済み医療用容器包装体、薬剤未混注の医療用容器包装体の製造方法、ならびに薬剤未混注の医療用容器包装体を実現することを課題とする。   The present invention has been made in view of such a situation, and without using a dedicated device or instrument such as a vacuum machine, the internal air can be easily discharged and the inflow of air can be prevented. Medical container packaging bag capable of suppressing deterioration of mixed solvent, method for containing medical container using the same, method for manufacturing medical container package with mixed drug, method for manufacturing medical container package without drug mixed, and It is an object of the present invention to realize a medical container package in which no medicine is mixed.

本発明者らは、鋭意検討した結果、以下の構成からなる包装袋を用いることにより、上記課題を解決することを見出し、本発明を完成するに至った。
すなわち、本発明の医療用容器包装袋は、ガスバリア性フィルムを用いて形成された医療用容器包装袋において、再開封可能な封止手段と、当該医療用容器包装袋の内部から外部へ空気を排出し、かつ外部から内部への空気流入を防止する逆止弁機構とを有することを特徴とする。
また、前記逆止弁機構の外気と接触する側の周縁部aを密封する密封代Aが設けられていることが好ましい。
さらに、前記封止手段の外気と接触する側の周縁部bを密封する密封代Bが設けられていることが好ましい。
As a result of intensive studies, the present inventors have found that the above problems can be solved by using a packaging bag having the following configuration, and have completed the present invention.
That is, the medical container packaging bag of the present invention is a medical container packaging bag formed using a gas barrier film, and sealing means that can be re-sealed and air from the inside of the medical container packaging bag to the outside. And a check valve mechanism that discharges air and prevents inflow of air from the outside to the inside.
Moreover, it is preferable that a sealing allowance A for sealing the peripheral edge portion a on the side of the check valve mechanism that contacts the outside air is provided.
Furthermore, it is preferable that a sealing allowance B for sealing the peripheral edge b on the side of the sealing means that comes into contact with the outside air is provided.

また、本発明の医療用容器の収容方法は、前記医療用容器包装袋を用い、封止手段を開封して薬剤が混注された医療用容器を収容した後、前記封止手段を封止し、当該医療用容器包装袋の内部の空気を逆止弁機構から外部へ排出することを特徴とする。
さらに、本発明の薬剤混注済み医療用容器包装体は、前記医療用容器の収容方法により薬剤が混注された医療用容器が包装されたことを特徴とする。
In the medical container housing method of the present invention, the medical container packaging bag is used, the sealing means is opened, the medical container mixed with the medicine is accommodated, and then the sealing means is sealed. The air inside the medical container packaging bag is discharged from the check valve mechanism to the outside.
Furthermore, the medical-contained medical container package of the present invention is characterized in that a medical container mixed with a medicine is packaged by the method for housing medical containers.

また、本発明の薬剤未混注の医療用容器包装体の製造方法は、前記医療用容器包装袋を用い、前記封止手段および逆止弁機構を有さない一辺を切断して開封部を設け、該開封部から薬剤未混注の医療用容器を収容した後、開封部を密封することを特徴とする。   Further, the method for producing a medical non-mixed medical container package according to the present invention uses the medical container packaging bag, and cuts one side not having the sealing means and the check valve mechanism to provide an opening portion. In addition, after the medical unmixed medical container is accommodated from the opening portion, the opening portion is sealed.

また、本発明の薬剤未混注の医療用容器包装体は、ガスバリア性フィルムを用いて形成された医療用容器包装袋に、薬剤未混注の医療用容器が包装された薬剤未混注の医療用容器包装体であって、前記医療用容器包装袋は、再開封可能な封止手段と、医療用容器包装袋の内部から外部へ空気を排出し、かつ外部から内部への空気流入を防止する逆止弁機構とを有し、かつ、前記封止手段および逆止弁機構の外気と接触する側の周縁部が密封されたことを特徴とする。   In addition, the medical unmixed medical container package of the present invention is a medical unmixed medical container in which a medical unmixed medical container is packaged in a medical container packaging bag formed using a gas barrier film. The medical container packaging bag includes a sealing means capable of re-sealing, and a reverse means for discharging air from the inside of the medical container packaging bag to the outside and preventing air from flowing from the outside to the inside. It has a valve stop mechanism, and the peripheral part on the side which contacts the outside air of the sealing means and the check valve mechanism is sealed.

本発明によれば、真空機などの専用の装置や器具を用いなくとも、内部の空気を容易に排出し、かつ空気の流入を防止し、医療用容器に混注された溶剤の変質を抑制できる医療用容器包装袋、およびこれを用いた医療用容器の収容方法、薬剤混注済み医療用容器包装体、薬剤未混注の医療用容器包装体の製造方法、ならびに薬剤未混注の医療用容器包装体を実現できる。
また、本発明によれば、薬剤未混注の医療用容器の搬送に用いた後、一旦開封して他の薬剤を医療用容器に混注し、薬剤混注済み医療用容器の保管に再使用できるので、医療用容器の搬送用と保管用に2種類の包装袋を使用する必要がなく、コストを低下でき、かつ、包装袋の廃棄量を半分に低減できる。
According to the present invention, the internal air can be easily discharged and the inflow of air can be prevented without using a dedicated device or instrument such as a vacuum machine, and the alteration of the solvent mixed in the medical container can be suppressed. MEDICAL CONTAINER PACKAGING BAG, METHOD FOR Storing MEDICAL CONTAINER USING THE SAME, MEDICAL CONTAINED MEDICAL CONTAINER PACKAGE BODY, METHOD FOR MANUFACTURING MEDIUM CONTAINER MEDICAL CONTAINER, AND MEDICAL UNMIXED MEDICAL CONTAINER Can be realized.
In addition, according to the present invention, after being used for transporting a medical container with no medicine mixed, it can be opened once, and another medicine can be mixed into the medical container and reused for storing the medical container with the medicine mixed. It is not necessary to use two types of packaging bags for transporting and storing medical containers, the cost can be reduced, and the amount of packaging bags discarded can be reduced by half.

以下、図を用いて本発明を詳細に説明する。
図1は、本発明の医療用容器包装袋(以下、「包装袋」という。)10の一例を示す平面図であり、図2は包装袋10の分解斜視図である。なお、この例の包装袋10は長方形の形状を示しているが、本発明においてはこれに限らず、他の形状の包装袋も実施可能である。
本発明の包装袋10は、図2に示すように、2枚のフィルム11が両側融着部11a、第1の底融着部11bおよび第2の底融着部11cでヒートシールされて袋状に形成される。各フィルム11はガスバリア性フィルムを備えており、該ガスバリア性フィルムと他のフィルムを積層した構造になっている。
Hereinafter, the present invention will be described in detail with reference to the drawings.
FIG. 1 is a plan view showing an example of a medical container packaging bag (hereinafter referred to as “packaging bag”) 10 according to the present invention, and FIG. 2 is an exploded perspective view of the packaging bag 10. In addition, although the packaging bag 10 of this example has shown the rectangular shape, in this invention, it is not restricted to this, The packaging bag of another shape can also be implemented.
As shown in FIG. 2, the packaging bag 10 of the present invention is a bag in which two films 11 are heat-sealed at both side fused portions 11a, a first bottom fused portion 11b, and a second bottom fused portion 11c. It is formed in a shape. Each film 11 includes a gas barrier film, and has a structure in which the gas barrier film and another film are laminated.

本発明に用いられるガスバリア性フィルムとしては、酸素バリア性を有するフィルムであればよく、例えば、ポリエステル、またはポリアミドからなるフィルムに、シリカ、アルミニウム、アルミナ等を蒸着させたフィルム、アルミニウム箔ラミネートフィルム、ポリビニルアルコールからなるフィルム、エチレン・ビニルアルコール共重合体からなるフィルム、ポリビニリデンクロライドからなるフィルム等が挙げられる。
ガスバリア性フィルムとしては、市販品を用いることもでき、例えば、凸版印刷株式会社製の「GLフィルム」、大日本印刷株式会社社製の「IBフィルム」、三菱樹脂株式会社製の「テックバリア」、株式会社クラレ製の「エバールフィルム」、旭化成株式会社製の「サランUB」、タマポリ株式会社製の「ハイトロンBX」などが挙げられる。
ガスバリア性フィルムの厚さは、7〜30μmが好ましい。
The gas barrier film used in the present invention may be any film having an oxygen barrier property, for example, a film obtained by vapor-depositing silica, aluminum, alumina or the like on a film made of polyester or polyamide, an aluminum foil laminate film, Examples thereof include a film made of polyvinyl alcohol, a film made of ethylene / vinyl alcohol copolymer, a film made of polyvinylidene chloride, and the like.
Commercially available products can be used as the gas barrier film. For example, “GL film” manufactured by Toppan Printing Co., Ltd., “IB film” manufactured by Dai Nippon Printing Co., Ltd., “Tech Barrier” manufactured by Mitsubishi Plastics, Inc. “Eval film” manufactured by Kuraray Co., Ltd., “Saran UB” manufactured by Asahi Kasei Co., Ltd., “Hyttron BX” manufactured by Tamapoli Co., Ltd., and the like.
The thickness of the gas barrier film is preferably 7 to 30 μm.

他のフィルムとしては、シーラントフィルムが挙げられる。シーラントフィルムを構成する樹脂としては、ポリエチレン、ポリプロピレンなどのポリオレフィンが好適である。特にポリエチレンが好ましく、中でも、低密度ポリエチレンおよび高強度な直鎖状低密度ポリエチレンが好ましい。これらシーラントフィルムの厚さは、収容する医療用容器の質量にもよるが、例えば30〜200μmが好ましく、40〜100μmがより好ましい。   Examples of other films include sealant films. As the resin constituting the sealant film, polyolefins such as polyethylene and polypropylene are suitable. Polyethylene is particularly preferable, and among them, low density polyethylene and high-strength linear low density polyethylene are preferable. Although the thickness of these sealant films depends on the mass of the medical container to be accommodated, for example, 30 to 200 μm is preferable, and 40 to 100 μm is more preferable.

また、他のフィルムとしては、上述したシーラントフィルム以外にも、酸素バリア性に加えて、水蒸気バリア性や遮光性を有するフィルムを併用してもよい。なお、遮光性を有するフィルム(遮光性フィルム)を併用する場合は、紫外線の透過を遮断または抑制する遮光性フィルムが好ましく、特にビタミンB1などを混注した輸液バッグなどの医療用容器を保管する際に好適である。このような遮光性フィルムとしては、例えば、一般的なアルミニウム箔、アルミニウム箔ラミネートフィルムの他に、市販品として、クリロン化成株式会社製の「イーグルカットUV」、住友大阪セメント株式会社製の「レイパリア」および「ZMF−110」などが挙げられる。遮光性フィルムの厚さは、7〜30μmが好ましい。   In addition to the above-described sealant film, in addition to the oxygen barrier property, a film having a water vapor barrier property and a light shielding property may be used in combination. When using a light-shielding film (light-shielding film) in combination, a light-shielding film that blocks or suppresses the transmission of ultraviolet rays is preferable, especially when storing medical containers such as infusion bags mixed with vitamin B1 and the like. It is suitable for. As such a light-shielding film, for example, in addition to general aluminum foil and aluminum foil laminate film, commercially available products such as “Eagle Cut UV” manufactured by Krillon Kasei Co., Ltd. and “Rayparia” manufactured by Sumitomo Osaka Cement Co., Ltd. And “ZMF-110”. The thickness of the light shielding film is preferably 7 to 30 μm.

本発明の包装袋10は、図1に示すように、再開封可能な封止手段12と、逆止弁機構13とを有する。
封止手段12は、前記2枚のフィルム11の間の開口部14側に配置されており、封止手段12を開封して1つ以上の医療用容器を開口部14から包装袋10に収容し、封止手段12を封止して包装袋10を密封する。
このような封止手段12としては、何度も開封および封止が可能であり、包装袋10内への医療用容器の出し入れができるものであれば特に限定されないが、例えば、チャック構造を有するもの、包装袋10の内面へ粘着剤を塗布したもの、粘着テープを貼付したもの、クランプで狭持したものなどが挙げられる。これらの中でも、操作性が良好で、かつ封止後の密封性に優れる点で、チャック構造を有するものが好ましい。
As shown in FIG. 1, the packaging bag 10 of the present invention includes a sealing means 12 that can be re-sealed and a check valve mechanism 13.
The sealing means 12 is disposed on the opening 14 side between the two films 11, and the sealing means 12 is opened to accommodate one or more medical containers in the packaging bag 10 from the opening 14. Then, the sealing means 12 is sealed and the packaging bag 10 is sealed.
Such a sealing means 12 is not particularly limited as long as it can be opened and sealed many times and the medical container can be taken in and out of the packaging bag 10, but has, for example, a chuck structure. For example, a case where a pressure-sensitive adhesive is applied to the inner surface of the packaging bag 10, a case where a pressure-sensitive adhesive tape is affixed, a case where a clamp is held, and the like. Among these, those having a chuck structure are preferable in terms of good operability and excellent sealing performance after sealing.

逆止弁機構13は、包装袋10の内部から外部へ空気を排出し、かつ外部から内部への空気流入を防止するものである。この例の逆止弁機構13は、前記封止手段12に対向して設けられているが、これに限定されず、他の位置に設けてもよい。
逆止弁機構13としては、上述した機能を有するものであれば特に限定されない。
The check valve mechanism 13 discharges air from the inside of the packaging bag 10 to the outside and prevents air from flowing from the outside to the inside. Although the check valve mechanism 13 of this example is provided to face the sealing means 12, it is not limited to this and may be provided at other positions.
The check valve mechanism 13 is not particularly limited as long as it has the above-described function.

ここで、図2を用いて、逆止弁機構13の一例について説明する。
この例の逆止弁機構13は、2枚のフィルム11の間に弁条片15を配置し、該弁条片15の上側融着部15aおよび下側融着部15bを各フィルム11にヒートシールすることで構成されている。なお、弁条片15の上側融着部15a、および下側融着部15bは、図1に示す2枚のフィルム11が接着した第1の底融着部11b、および第2の底融着部11cと各々重なる。
弁条片15の材質としては、例えばポリエチレン、ポリプロピレン、エチレン酢酸ビニル共重合体などが挙げられる。
Here, an example of the check valve mechanism 13 will be described with reference to FIG.
The check valve mechanism 13 in this example arranges a valve strip 15 between two films 11, and heats the upper fusion portion 15 a and the lower fusion portion 15 b of the valve piece 15 to each film 11. It is configured by sealing. In addition, the upper side fusion | fusion part 15a and the lower side fusion | fusion part 15b of the valve strip 15 are the 1st bottom fusion | fusion part 11b and 2nd bottom fusion | fusion which the two films 11 shown in FIG. 1 adhere | attached Each overlaps with the part 11c.
Examples of the material of the valve strip 15 include polyethylene, polypropylene, and ethylene vinyl acetate copolymer.

弁条片15は、上側融着部15aおよび下側融着部15bの接着により2つの連通路が形成され、上側連通路は一方のフィルム11と弁条片15の間に形成され、下側連通路は他方のフィルム11と弁条片15の間に形成される。
各連通路の幅W1は、包装袋10の大きさにもよるが、1〜8cmが好ましい。また、連通路の第1の通路口15cの口径Wc2、および第2の通路口15dの口径Wd2は、包装袋10の幅Wの1/30〜1/10倍が好ましい。なお、通路口15cの口径Wc2と通路口15dの口径Wd2は同一であってもよく、異なっていてもよい。また、包装袋10の幅Wは、収容する医療用容器の大きさや収容数によって適宜変化するので制限されないが、例えば10〜50cmが好ましい。
The valve strip 15 has two communication passages formed by adhesion of the upper fusion portion 15a and the lower fusion portion 15b, and the upper communication passage is formed between one film 11 and the valve piece 15 and is A communication path is formed between the other film 11 and the valve strip 15.
The width W1 of each communication path is preferably 1 to 8 cm, although it depends on the size of the packaging bag 10. Further, the diameter Wc2 of the first passage port 15c of the communication passage and the diameter Wd2 of the second passage port 15d are preferably 1/30 to 1/10 times the width W of the packaging bag 10. The diameter Wc2 of the passage opening 15c and the diameter Wd2 of the passage opening 15d may be the same or different. In addition, the width W of the packaging bag 10 is not limited because it appropriately changes depending on the size and number of medical containers to be accommodated, but is preferably 10 to 50 cm, for example.

包装袋10に医療用容器が収容されていない場合、弁条片15の両面は、各フィルム11と接触している。そして、医療用容器が収容され、前記封止手段12が封止されて包装袋10内部の圧力が袋外部の押圧等により周囲の気圧よりも高くなると、包装袋10内部の空気が連通路の第1の通路口15cを通過し、上側連通路および下側連通路を経て第2の通路口15dから排出される。次いで、包装袋10の周囲の空気の圧力が、各シート11を弁条片15に押し付けることで、上側連通路および下側連通路が閉じられ、外部からの空気の流入を防ぐ。   When the medical container is not accommodated in the packaging bag 10, both surfaces of the valve strip 15 are in contact with the films 11. Then, when the medical container is accommodated and the sealing means 12 is sealed and the pressure inside the packaging bag 10 becomes higher than the surrounding air pressure due to the pressure outside the bag, etc., the air inside the packaging bag 10 is connected to the communication path. It passes through the first passage port 15c and is discharged from the second passage port 15d through the upper communication passage and the lower communication passage. Next, the pressure of the air around the packaging bag 10 presses each sheet 11 against the valve strip 15, whereby the upper communication path and the lower communication path are closed to prevent inflow of air from the outside.

包装袋10内の空気の排出方法としては、例えば、図10(a)、(b)に示すように手などを使って包装袋10の片方の面を押しつけて圧縮する方法、封止手段12から逆止弁機構13に向けて折り曲げたり、しごき操作を行ったりして圧縮する方法などが挙げられる。本発明によれば、このような簡便な方法によって包装袋10内部の空気を排出させることによって、容器と包装袋との空間の空気を包装袋10内から容易に排出することができる。また、外部からの空気などの流入を防止するので、特に医療用容器に混注された薬剤の変質を抑制できる。
なお、本発明においては、薬剤を混注していない医療用容器を「薬剤未混注の医療用容器」、該薬剤未混注の医療用容器に他の薬剤を混注したものを「薬剤混注済み医療用容器」という。
As a method for discharging the air in the packaging bag 10, for example, as shown in FIGS. 10A and 10B, a method of compressing one side of the packaging bag 10 by pressing with one hand or the like, sealing means 12 And a method of compressing by bending toward the check valve mechanism 13 or performing an ironing operation. According to the present invention, the air in the space between the container and the packaging bag can be easily discharged from the inside of the packaging bag 10 by discharging the air inside the packaging bag 10 by such a simple method. In addition, since the inflow of air or the like from the outside is prevented, it is possible to suppress the deterioration of the medicine mixed especially in the medical container.
In the present invention, a medical container not mixed with a drug is referred to as a “medicine-unmixed medical container”, and a non-drug-mixed medical container is mixed with another drug as a “medicine-mixed medical container” It is called a “container”.

本発明においては、逆止弁機構13としては上述したものに制限されず、例えば図3〜5に示すようなものも用いることができる。
ここで、図3〜5に示す逆止弁機構13について説明する。
In the present invention, the check valve mechanism 13 is not limited to the above-described one, and for example, the one shown in FIGS.
Here, the check valve mechanism 13 shown in FIGS.

図3(a)に示す包装袋100は、2枚のフィルム111が両側融着部111a、および底融着部111bでヒートシールされて袋状に形成され、開口部114には封止手段112が設けられ、底部には逆止弁機構113が設けられている。なお、逆止弁機構113は、底融着部111bの一部を貫通するように取り付けられており、逆止弁機構113が取り付けられた部分の底融着部111bは、ヒートシールされていないものとする。
逆止弁機構113は、図3(b)に示すように、包装袋100の内部と外部とが連続するようにシートを扁平な筒状とした外筒部113aと、この外筒部113aの内部に設けられた弁条シート113bとを備えている。弁条シート113bを設けることで、包装袋100の内部から外部への空気の流れ(気流)を促し、逆方向の気流を遮断できる。
The packaging bag 100 shown in FIG. 3A is formed into a bag shape by heat-sealing two films 111 at both side fusion portions 111a and bottom fusion portions 111b. And a check valve mechanism 113 is provided at the bottom. The check valve mechanism 113 is attached so as to penetrate a part of the bottom fusion part 111b, and the bottom fusion part 111b of the part to which the check valve mechanism 113 is attached is not heat-sealed. Shall.
As shown in FIG. 3B, the check valve mechanism 113 includes an outer cylinder portion 113a having a flat cylindrical sheet so that the inside and the outside of the packaging bag 100 are continuous, and the outer cylinder portion 113a. And a valve seat 113b provided inside. By providing the valve sheet 113b, the air flow (air flow) from the inside to the outside of the packaging bag 100 can be promoted, and the air flow in the reverse direction can be blocked.

逆止弁機構113を包装袋100の底部に設ける際には、融着部113cにてヒートシールし、各フィルム111と外筒部113aとを接着させればよい。なお、接着の際に、弁条シート113bもヒートシールされるのを防止する目的で、外筒部113aの内面と対向する側の弁条シート113bの表面に、溶融防止塗料を塗布しておいてもよい。
外筒部113aおよび弁条シート113bの材質としては、先に例示した弁条片15の材質の中から1種以上を選択して用いることができる。
When the check valve mechanism 113 is provided at the bottom of the packaging bag 100, the film 111 and the outer cylinder portion 113a may be bonded by heat sealing at the fusion portion 113c. In order to prevent the valve sheet 113b from being heat-sealed at the time of bonding, an anti-melting paint is applied to the surface of the valve sheet 113b on the side facing the inner surface of the outer cylinder part 113a. May be.
As the material of the outer tube portion 113a and the valve sheet 113b, one or more types can be selected and used from the materials of the valve strip 15 exemplified above.

図4(a)に示す包装袋200は、2枚のフィルム211が両側融着部211a、および底融着部211bでヒートシールされて袋状に形成され、開口部214には封止手段212が設けられ、底部には逆止弁機構213が設けられている。
なお、底融着部211bをヒートシールする際には、図4(a)、(f)に示す斜線部のような形状の金型を用いてヒートシールすればよい。
The packaging bag 200 shown in FIG. 4A is formed into a bag shape by heat-sealing two films 211 at both side fused portions 211a and bottom fused portions 211b. And a check valve mechanism 213 is provided at the bottom.
In addition, when heat-sealing the bottom fusion | bond part 211b, what is necessary is just to heat-seal using the metal mold | die like a shaded part shown to Fig.4 (a), (f).

この例の逆止弁機構213は、図4(f)に示すように、2枚の弁条シート213aおよび2枚の台座シート213bが、2枚のフィルム211の間に配置されることで構成されている。そして、包装袋200の内部の空気を排出する際には、図4(b)、(d)に示すように空気通路部Pが形成され、包装袋200の内部から外部へ空気を排出することが可能となる。なお、弁条シート213aはその一部が、空気通路部Pが閉鎖されるまで可動可能となっており、弁条シート213aに接着された各フィルム211に対して一方の弁条シート213aの一部が浮き上がって他方の弁条シート213a密着することで、空気通路部Pを封鎖できる(図4(c)、(e))。これにより、包装袋200の外部から内部への空気の流入を抑制できる。
弁条シート213aの材質としては、先に例示した弁条片15の材質の中から1種以上を選択して用いることができる。
As shown in FIG. 4F, the check valve mechanism 213 of this example is configured by arranging two valve sheets 213a and two pedestal sheets 213b between two films 211. Has been. When the air inside the packaging bag 200 is discharged, an air passage portion P is formed as shown in FIGS. 4B and 4D, and the air is discharged from the inside of the packaging bag 200 to the outside. Is possible. A portion of the valve sheet 213a is movable until the air passage portion P is closed, and one valve sheet 213a is attached to each film 211 adhered to the valve sheet 213a. The air passage part P can be blocked by the part rising and closely contacting the other valve sheet 213a (FIGS. 4C and 4E). Thereby, inflow of air from the outside to the inside of the packaging bag 200 can be suppressed.
As the material of the valve sheet 213a, one or more kinds can be selected and used from the materials of the valve piece 15 exemplified above.

図5(a)に示す包装袋300は、2枚のフィルム311が両側融着部311a、および底融着部311bでヒートシールされて袋状に形成され、開口部314には封止手段312が設けられ、底部には逆止弁機構313が設けられている。
この例の包装袋300は、図5(a)に示すように、底融着部311bから所定距離おいた位置において、底融着部311bに対して平行になるようにヒートシールされた区画シール311cが形成されている。
A packaging bag 300 shown in FIG. 5A is formed into a bag shape by heat-sealing two films 311 at both side fused portions 311a and bottom fused portions 311b. And a check valve mechanism 313 is provided at the bottom.
As shown in FIG. 5A, the packaging bag 300 of this example is a compartment seal heat-sealed so as to be parallel to the bottom fused portion 311b at a position a predetermined distance from the bottom fused portion 311b. 311c is formed.

逆止弁機構313は、図5(b)に示すように、1枚の弁条シート313aが、2枚のフィルム311の間に配置されることで構成されている。弁条シート313aの一方の面は、その周囲辺のうちの3辺が一方のフィルム311’と密着し、弁条シート313aの他方の面は、全ての周囲辺が他方のフィルム311’’と密着しており、このような構造とすることにより連通路313bが形成されている。また、区画シール311cは一部が途中で途切れたものとされていて、途切れた部分が連通部311dとなり、包装袋300内部と連通路313bを連通させている。さらに、一方のフィルム311の連通路313bには、脱気孔313cが設けられており、包装袋300内部の空気は、連通部311dおよび連通路313bを通過して脱気孔313cから排出される。
なお、弁条シート313aの他方の面は、他方のフィルム311’’と密着している以外の部分が、他方のフィルム311’’に対して離反可能となっている。従って、弁条シート313aが他方のフィルム311’’に対して浮き上がり、一方のシート311’に対して密着することで脱気孔313cを塞ぐことができる。これにより、包装袋300の外部から内部への空気の流入を抑制できる。また、脱気孔313cを覆うように、一方のフィルム311’に対して脱着可能なシール部材313dを、一方のフィルム311’に設けておき、包装袋300内の空気を排出後、シール部材313dにて脱気孔313cを塞げば、より効果的に空気の流入を抑制できる。
弁条シート313aの材質としては、先に例示した弁条片15の材質の中から1種以上を選択して用いることができる。
As shown in FIG. 5B, the check valve mechanism 313 is configured by arranging a single valve sheet 313 a between two films 311. One side of the valve sheet 313a is in close contact with one film 311 ′ of the peripheral sides, and the other side of the valve sheet 313a is all the peripheral sides with the other film 311 ″. The communication path 313b is formed by having such a structure. In addition, a part of the partition seal 311c is assumed to be interrupted in the middle, and the interrupted portion serves as a communication portion 311d, which communicates the inside of the packaging bag 300 and the communication path 313b. Further, the communication passage 313b of one film 311 is provided with a deaeration hole 313c, and the air inside the packaging bag 300 passes through the communication part 311d and the communication passage 313b and is discharged from the deaeration hole 313c.
The other surface of the valve sheet 313a can be separated from the other film 311 '' except for the portion that is in close contact with the other film 311 ''. Accordingly, the degassing hole 313c can be blocked by the valve sheet 313a being lifted with respect to the other film 311 ″ and being in close contact with the other sheet 311 ′. Thereby, the inflow of air from the outside to the inside of the packaging bag 300 can be suppressed. Further, a sealing member 313d that can be attached to and detached from one film 311 ′ is provided on one film 311 ′ so as to cover the deaeration hole 313c, and after the air in the packaging bag 300 is discharged, the sealing member 313d If the deaeration hole 313c is closed, the inflow of air can be suppressed more effectively.
As the material of the valve sheet 313a, one or more kinds can be selected and used from the materials of the valve piece 15 exemplified above.

本発明においては、逆止弁機構として上述した以外の構成のものを用いることも可能であるが、成形が容易な点から図1、2に示すような逆止弁機構13が好ましい。   In the present invention, it is possible to use a check valve mechanism having a configuration other than that described above, but the check valve mechanism 13 shown in FIGS.

本発明の包装袋は、上述したような封止手段および逆止弁機構を有することにより、医療用容器の出し入れと、包装袋内の空気の排出が可能となり、かつ、外部からの空気の流入を抑制できるので、特に薬剤混注済み医療用容器の保管に適している。
本発明の包装袋を用いて薬剤を混注した薬剤混注済み医療用容器を収容して保管する場合、まず、図6(a)に示すように、封止手段12を開封して薬剤混注済み医療用容器71を収容して、封止手段12を封止する。次いで、図6(b)に示すように、包装袋10内部の空気を逆止弁機構13から外部へ排出する収容方法を用いることで、薬剤混注済み医療用容器包装体50が得られ、薬剤混注済み医療用容器71を密封した状態で保管できる。保管の際には、医療用容器に混注した薬剤の安定性を考慮して、冷蔵庫などの冷暗所にて保管するのが好ましい。
The packaging bag of the present invention has the sealing means and the check valve mechanism as described above, so that the medical container can be taken in and out, the air in the packaging bag can be discharged, and the inflow of air from the outside. This is particularly suitable for storing medically mixed medical containers.
In the case of storing and storing a medicine-mixed medical container into which a medicine is mixed using the packaging bag of the present invention, first, as shown in FIG. The container 71 is accommodated and the sealing means 12 is sealed. Next, as shown in FIG. 6 (b), by using a housing method in which the air inside the packaging bag 10 is discharged from the check valve mechanism 13 to the outside, a medically mixed medical container package 50 is obtained. The mixed medical container 71 can be stored in a sealed state. In storage, it is preferable to store in a cool and dark place such as a refrigerator in consideration of the stability of the medicine mixed in the medical container.

また、本発明の包装袋は、薬剤未混注の医療用容器を病院などに搬送する際に用いることもできる。このような場合、他の薬剤を混注するタイミングにおいて封止手段を開封して薬剤未混注の医療用容器を取り出し、他の薬剤を混注した後、同じ包装袋に再度収容して封止手段を封止し、包装袋内部の空気を逆止弁機構から外部へ排出することで、薬剤混注済み医療用容器を密封した状態で保管できる。
このように、本発明によれば、医療用容器の搬送に用いた包装袋を保管用に再使用できる。
Moreover, the packaging bag of this invention can also be used when conveying the medical container with no medicine mixed injection to a hospital etc. In such a case, the sealing means is unsealed at the timing when other drugs are mixed and taken out, and the medical container not filled with the medicine is taken out.After other drugs are mixed and mixed, the sealing means is stored again in the same packaging bag. By sealing and discharging the air inside the packaging bag from the check valve mechanism to the outside, it is possible to store the medical container with the medicine mixed in a sealed state.
Thus, according to this invention, the packaging bag used for conveyance of a medical container can be reused for storage.

なお、包装袋内の空気の排出の際には、図1に示す第2の通路口15dに真空機などを設置し、該真空機により包装袋内を脱気してもよい。
ただし、本発明においては、包装袋を圧縮するなどの簡便な方法によって包装袋内の空気を外部へ排出できるので、真空機などの専用の装置や器具を用いなくても、包装袋内部の空気を容易に脱気し、かつ外部からの空気の流入を防止するので、特に医療用容器に混注された薬剤の変質を抑制できる。
When the air in the packaging bag is discharged, a vacuum machine or the like may be installed in the second passage port 15d shown in FIG. 1, and the inside of the packaging bag may be deaerated with the vacuum machine.
However, in the present invention, since the air in the packaging bag can be discharged to the outside by a simple method such as compressing the packaging bag, the air inside the packaging bag can be used without using a dedicated device or instrument such as a vacuum machine. Can be easily degassed and the inflow of air from the outside is prevented, so that the alteration of the medicine mixed in the medical container can be particularly suppressed.

また、微量の酸素にも影響を受けやすい薬剤を混注した医療用容器内を包装袋に収容する場合は、該医療用容器と共に、脱酸素剤を包装袋に収容して保管するのが好ましい。脱酸素剤としては、酸素を除去できるものであればよく、例えばアモルファス銅を用いた脱酸素剤が挙げられる。市販品としては、三菱瓦斯化学株式会社製の「エージレス」などが使用できる。   In addition, when the inside of a medical container in which a medicine that is easily affected by a small amount of oxygen is mixed and contained in a packaging bag, it is preferable to store the oxygen scavenger in the packaging bag together with the medical container. Any oxygen scavenger can be used as long as it can remove oxygen. Examples thereof include an oxygen scavenger using amorphous copper. As commercial products, “AGELESS” manufactured by Mitsubishi Gas Chemical Co., Ltd. can be used.

本発明の包装袋においては、図7に示すように、逆止弁機構13の外気と接触する側の周縁部aに、密封代Aが設けられた構造とするのが好ましい。このような構造とすることで、逆止弁機構13の周縁部aが密封されるので、包装袋10の外部から内部へ外気が流入するのをより抑制することができ、薬剤混注済み医療用容器の保管に用いられる直前まで包装袋内をより衛生的に保持できる。
このような包装袋を薬剤混注済み医療用容器の保管に用いる際には、周縁部aの任意の箇所、例えば図7に示す切断線16に沿って切断することで、逆止弁機構13の周縁部aが露出し、包装袋内部の空気を外部へ放出可能となる。
As shown in FIG. 7, the packaging bag of the present invention preferably has a structure in which a sealing margin A is provided at the peripheral edge portion a on the side of the check valve mechanism 13 that contacts the outside air. With such a structure, since the peripheral edge a of the check valve mechanism 13 is sealed, it is possible to further suppress the flow of outside air from the outside of the packaging bag 10 to the inside, and for medical use that has been mixed with a medicine. The packaging bag can be kept more hygienic until just before being used for storage of the container.
When such a packaging bag is used for storing a medical container with mixed medicines, the check valve mechanism 13 can be cut by cutting along an arbitrary portion of the peripheral edge a, for example, along the cutting line 16 shown in FIG. The peripheral edge part a is exposed, and the air inside the packaging bag can be released to the outside.

さらに、封止手段12の外気と接触する側の周縁部b(すなわち開口部)に、密封代Bが設けられた構造とするのが好ましい。このような構造とすることで、封止手段12の周縁部bが密封されるので、薬剤混注済み医療用容器の保管に用いられる直前まで包装袋内をより衛生的に保持できる。
このような包装袋を薬剤混注済み医療用容器の保管に用いる際には、周縁部bの任意の箇所、例えば図7に示す切断線17に沿って切断することで、封止手段12の周縁部bが露出するので、封止手段12を開封して薬剤混注済み医療用容器を包装袋内に収容できる。
Furthermore, it is preferable that a sealing margin B is provided at the peripheral edge b (that is, the opening) on the side of the sealing means 12 that contacts the outside air. By setting it as such a structure, since the peripheral part b of the sealing means 12 is sealed, the inside of a packaging bag can be hold | maintained more hygienically just before it is used for storage of the medical container by which medicine mixing was carried out.
When such a packaging bag is used for storing a medical container with mixed medicines, the peripheral edge of the sealing means 12 can be cut by cutting along an arbitrary portion of the peripheral edge b, for example, along the cutting line 17 shown in FIG. Since the part b is exposed, the sealing means 12 can be opened, and the medical container mixed with medicine can be accommodated in the packaging bag.

なお、切断線16、17に沿って密封代A、Bを切断する際には、ハサミなどの刃物を使用して切断しても構わないが、直線カット性を有するフィルムを使用したり、切断開始部にノッチを設けたり粗面加工を施したりすることで、刃物などの器具を用いて切断しやすくなることはもちろんのこと、器具を用いることなく手で開封するように切断することも可能になる。   In addition, when cutting the sealing allowances A and B along the cutting lines 16 and 17, it may be cut using a blade such as scissors, but a film having a straight cut property may be used or cut. By providing a notch at the start or roughening the surface, it will be easier to cut with a tool such as a blade, and it can also be cut by hand without using a tool. become.

図7に示すように、包装袋を、逆止弁機構13の周縁部aに密封代Aを、封止手段12の周縁部bに密封代Bを各々設けた構造の包装袋20とすることで、周縁部aおよび周縁部bは密封されるので、逆止弁機構13および封止手段12は保護されることとなる。
従って、包装袋を薬剤未混注の医療用容器の搬送に用いる際に、搬送の衝撃などから封止手段12や逆止弁機構13を保護し、これらの損傷を効果的に抑制できる。
包装袋20は、密封代Aと密封代Bの両方が設けられた構造でもよく、いずれか一方の密封代が設けられた構造でもよいが、両方の密封代が設けられた構造がより好ましい。
As shown in FIG. 7, the packaging bag is a packaging bag 20 having a structure in which a sealing margin A is provided at the peripheral portion a of the check valve mechanism 13 and a sealing margin B is provided at the peripheral portion b of the sealing means 12. Thus, since the peripheral edge portion a and the peripheral edge portion b are sealed, the check valve mechanism 13 and the sealing means 12 are protected.
Therefore, when the packaging bag is used for transporting a medical container not mixed with medicine, the sealing means 12 and the check valve mechanism 13 are protected from the impact of transport and the like, and these damages can be effectively suppressed.
The packaging bag 20 may have a structure in which both a sealing allowance A and a sealing allowance B are provided, or may have a structure in which any one sealing allowance is provided, but a structure in which both sealing allowances are provided is more preferable.

このような構造の包装袋20を医療用容器の搬送に用いる際には、例えば図8(a)に示す包装袋30内に薬剤未混注の医療用容器72を収容した後、封止手段12の周縁部bを密封することで、図8(b)に示すような薬剤未混注の医療用容器包装体60を作製してもよいが、次のような方法を用いてもよい。   When the packaging bag 20 having such a structure is used for transporting a medical container, for example, after the medical container 72 with no medicine mixed therein is accommodated in the packaging bag 30 shown in FIG. By sealing the peripheral edge b, a medical container package 60 with no medicine mixed as shown in FIG. 8B may be produced, but the following method may be used.

封止手段12の周縁部b、および逆止弁機構13の周縁部aが密封された状態で、かつ包装袋同士が両側融着部11aで連結した状態で製造された連結包装袋40(図9(a))を、両側融着部11aに対して平行な切断線18にて切断して開封部19を設け、薬剤未混注の医療用容器72を開封部19から収容し(図9(b))、さらに開封部19をヒートシールなどにより接合することで、図8(b)に示すような薬剤未混注の医療用容器包装体60を作製する。連結包装袋40を切断する際は、切断後に個別となった包装袋が1つの両側融着部11aを有するように(すなわち、片側が融着部、もう一方の片側が開封部となるように)切断線18を設定すればよく、具体的には、両側融着部11aの端部からの距離dが0〜10mmとなるような位置に切断線18を設定するのが好ましい。なお、距離dが0mmとなるように切断線18を設定した場合、切断後に個別となった包装袋は、図9(b)に示すような構造になる。
このような方法によれば、封止手段12の開封、封止操作を行わなくても、切断、ヒートシールなどの簡便な操作で、かつ量産的に薬剤未混注の医療用容器72を包装袋に収容でき、さらには、封止手段12や逆止弁機構13の損傷を効果的に抑制しながら病院などまで搬送できる。
The connected packaging bag 40 (FIG. 6) manufactured in a state where the peripheral edge b of the sealing means 12 and the peripheral edge a of the check valve mechanism 13 are sealed and the packaging bags are connected to each other by the double-side fused portions 11a. 9 (a)) is cut at a cutting line 18 parallel to the both side fusion parts 11a to provide an opening part 19, and a medical container 72 with no medicine mixed therein is accommodated from the opening part 19 (FIG. 9 ( b)) Further, the unsealed medical container package 60 as shown in FIG. 8B is manufactured by joining the opening 19 by heat sealing or the like. When cutting the connected packaging bag 40, the individual packaging bags after cutting have one double-side fused portion 11a (that is, one side serves as a fused portion and the other side serves as an unsealed portion). ) The cutting line 18 may be set. Specifically, it is preferable to set the cutting line 18 at a position where the distance d from the end of the both-side fused part 11a is 0 to 10 mm. In addition, when the cutting line 18 is set so that the distance d is 0 mm, the individual packaging bag after cutting has a structure as shown in FIG.
According to such a method, even if the sealing means 12 is not opened and sealed, the medical container 72 containing the unmixed medicine in a mass production can be obtained by a simple operation such as cutting and heat sealing. Furthermore, it can be transported to a hospital or the like while effectively suppressing damage to the sealing means 12 and the check valve mechanism 13.

なお、本発明の包装袋の製造方法については、特に制限されないが、例えば、次のようにして製造できる。
まず、ガスバリア性フィルムとシーラントフィルムとを、接着剤を介してドライラミネート法により積層し、ガスバリア性積層フィルムを2枚作製する。
次いで、封止手段および逆止弁機構を、図1に示すような配置構成になるように、2枚のガスバリア性積層フィルムで挟持し、図1や図7に示すような構造になるように両側融着部や底融着部など、必要な箇所をヒートシールして溶着させることで製造できる。
In addition, although it does not restrict | limit especially about the manufacturing method of the packaging bag of this invention, For example, it can manufacture as follows.
First, a gas barrier film and a sealant film are laminated by an adhesive with a dry lamination method to produce two gas barrier laminated films.
Next, the sealing means and the check valve mechanism are sandwiched between two gas barrier laminated films so as to have the arrangement as shown in FIG. 1, so that the structure as shown in FIG. 1 or FIG. 7 is obtained. It can be manufactured by heat-sealing and welding necessary portions such as both-side fused portions and bottom fused portions.

以上のように、本発明によれば、再開封可能な封止手段と、逆止弁機構を備えることにより、医療用容器の出し入れと、包装袋内の空気の排出が可能となる。
従って、本発明の包装袋を用いて薬剤を混注した薬剤混注済み医療用容器を保管する場合、封止手段を開封して薬剤混注済み医療用容器を収容し、封止手段を封止し、包装袋内部の空気を逆止弁機構から外部へ排出することで、薬剤混注済み医療用容器を密封した状態で保管できる。逆止弁機構は、包装袋外部から内部への空気の流入を防止できるので、空気などに対して不安定な溶剤を医療用容器に混注した場合であっても、溶剤の変質を抑制できる。
As described above, according to the present invention, the sealing means capable of re-sealing and the check valve mechanism are provided, so that the medical container can be taken in and out and the air in the packaging bag can be discharged.
Therefore, when storing a mixed medicine medical container mixed with a medicine using the packaging bag of the present invention, the sealing means is opened to accommodate the mixed medicine medical container, and the sealing means is sealed, By discharging the air inside the packaging bag from the check valve mechanism to the outside, it is possible to store the medical container with the medicine mixed in a sealed state. Since the check valve mechanism can prevent the inflow of air from the outside to the inside of the packaging bag, the deterioration of the solvent can be suppressed even when a solvent unstable to air or the like is mixedly injected into the medical container.

さらに、本発明の包装袋であれば、溶剤未混注の医療用容器の搬送に用いた後に、溶剤混注済み医療用容器の保管にも再使用可能であるので、包装袋の廃棄量を低減できる。   Furthermore, the packaging bag of the present invention can be reused for storage of a solvent-mixed medical container after it is used for transporting a solvent-unmixed medical container, thereby reducing the amount of packaging bag discarded. .

以下、本発明の実施例を説明するが、本発明はこれらの実施例に限定されるものではない。
[実施例1]
<包装袋の製造>
ガスバリア性フィルム(凸版印刷株式会社製、「GLフィルム GL−AU」、厚さ:15μm)と、直鎖状低密度ポリエチレン性シーラントフィルム(厚さ:60μm)とを、ウレタン系接着剤を使用してドライラミネートにより積層し、さらに封止手段としてチャック(出光ユニテック株式会社製)をヒートシールにより取り付けたガスバリア性積層フィルムを作成した。このフィルムを50cm×40cmに切断した。
切断したフィルム2枚を使用し、シーラントフィルム面同士が接するように重ね合わせ、図2に示すような逆止弁機構13を制作し、開口部14(封止手段の周縁部b)を除く3方をヒートシールし、図8(a)に示すような、逆止弁機構13の周縁部aも密封代Aにて密封された包装袋30を製造した。
次に、薬剤未混注の医療用容器72として、500mlアミノ酸含有製剤輸液バッグと、脱酸素剤(三菱瓦斯化学株式会社製、「エージレス」)を、封止手段12を開封して包装袋30内に収容し、封止手段を封止して、開口部(封止手段の周縁部)に設けた密封代Bを密封し、図8(b)に示すような薬剤未混注の医療用容器包装体60を製造した。
Examples of the present invention will be described below, but the present invention is not limited to these examples.
[Example 1]
<Manufacture of packaging bags>
Gas barrier film (made by Toppan Printing Co., Ltd., “GL film GL-AU”, thickness: 15 μm) and linear low density polyethylene sealant film (thickness: 60 μm) are used with urethane adhesive. Then, a gas barrier laminated film was prepared by laminating by dry lamination and further attaching a chuck (manufactured by Idemitsu Unitech Co., Ltd.) as a sealing means by heat sealing. This film was cut into 50 cm × 40 cm.
Using two cut films, the sealant film surfaces are overlapped so that the sealant film surfaces are in contact with each other, and a check valve mechanism 13 as shown in FIG. 2 is produced, and the opening 14 (the peripheral edge b of the sealing means) is excluded. The packaging bag 30 in which the peripheral edge a of the check valve mechanism 13 was also sealed with a sealing allowance A as shown in FIG.
Next, as an unmixed medical container 72, a 500 ml amino acid-containing preparation infusion bag and an oxygen scavenger (manufactured by Mitsubishi Gas Chemical Co., Ltd., “AGELESS”) are opened in the sealing bag 12 and the packaging bag 30 The sealing means is sealed, the sealing margin B provided at the opening (peripheral edge of the sealing means) is sealed, and the medical container packaging with no medicine mixed as shown in FIG. 8 (b) A body 60 was produced.

この医療用容器包装体60の密封代A、Bを、切断線16、17に沿って切断し、封止手段12を開封して薬剤未混注の医療用容器72を取り出し、他の薬剤としてビタミンB1製剤を混注した。薬剤混注済み医療用容器71を、密封代A、Bを切断した先の包装袋に戻し、封止手段12を封止した後、図10(a)に示すように包装袋の片方の面を手で押して圧縮し、包装袋内の空気を逆止弁機構13から排出した後(図10(b))、4℃の冷蔵庫で一週間保管した。
一週間保管後の薬剤混注済み医療用容器を目視にて観察した結果、外観上の変化は見られなかった。
The sealing allowances A and B of the medical container package 60 are cut along the cutting lines 16 and 17, the sealing means 12 is opened, and the medical container 72 with no medicine mixed is taken out, and vitamins are used as other medicines. B1 formulation was mixed. After the medical mixed container 71 is returned to the previous packaging bag from which the sealing margins A and B have been cut and the sealing means 12 is sealed, one side of the packaging bag is attached as shown in FIG. After pressing by hand and compressing, the air in the packaging bag was discharged from the check valve mechanism 13 (FIG. 10B), and stored in a refrigerator at 4 ° C. for one week.
As a result of visual observation of the medical mixed container after one week storage, no change in appearance was observed.

[実施例2]
実施例1と同様のガスバリア性積層フィルムを使用し、4方をヒートシールし、図7に示すような、逆止弁機構13の周縁部a、および封止手段12の周縁部bが密封代Aおよび密封代Bにて密封された包装袋20を製造した。
[Example 2]
Using the same gas barrier laminate film as in Example 1, heat sealing is performed on the four sides, and the peripheral edge a of the check valve mechanism 13 and the peripheral edge b of the sealing means 12 as shown in FIG. A packaging bag 20 sealed with A and a sealing allowance B was manufactured.

従来の包装袋に保管された薬剤未混注の医療用容器(500mlアミノ酸含有製剤輸液バッグ)を、包装袋から取り出し、他の薬剤としてビタミンB1製剤を混注した。
先に製造した包装袋20の密封代A、Bを、切断線16、17に沿って切断し、封止手段12を開封して、薬剤混注済み医療用容器を収容し、封止手段12を封止した。これ以降の操作を実施例1と同様に行った。
一週間保管後の薬剤混注済み医療用容器を目視にて観察した結果、外観上の変化は見られなかった。
A medical non-mixed medical container (500 ml amino acid-containing preparation infusion bag) stored in a conventional packaging bag was taken out from the packaging bag, and vitamin B1 preparation was mixed and injected as another drug.
The sealing allowances A and B of the packaging bag 20 produced earlier are cut along the cutting lines 16 and 17, the sealing means 12 is opened, the medicine mixed medical container is accommodated, and the sealing means 12 is Sealed. Subsequent operations were performed in the same manner as in Example 1.
As a result of visual observation of the medical mixed container after one week storage, no change in appearance was observed.

[実施例3]
薬剤未混注の医療用容器72として、剥離可能な隔壁で仕切られた2室に糖および電解質液と、アミノ酸液とが各々収容された輸液バッグ(内容量:1200mL)を用い、混注操作として、2室を仕切る隔壁を開通させて混合させる操作を行った以外は、実施例1と同様の操作を実施した。
4℃の冷蔵庫で3日間保管後の薬剤混注済み医療用容器を目視にて観察した結果、外観上の変化は見られなかった。
[Example 3]
As an unmixed medical container 72, an infusion bag (with an internal volume of 1200 mL) containing sugar and an electrolyte solution and an amino acid solution in two chambers separated by a removable partition wall, The same operation as in Example 1 was carried out except that the partition partitioning the two chambers was opened and mixed.
As a result of visually observing the medically mixed medical container after storage for 3 days in a refrigerator at 4 ° C., no change in appearance was observed.

[比較例1]
薬剤混注済み医療用容器を包装袋に収容しなかった以外は、実施例1と同様に行った。
一週間保管後の薬剤混注済み医療用容器を目視にて観察した結果、医療用容器の内溶液には変色が認められ、沈殿物が確認できた。
[Comparative Example 1]
The same procedure as in Example 1 was carried out except that the medical container into which the medicine was mixed was not accommodated in the packaging bag.
As a result of visually observing the medical mixed container after one week storage, discoloration was observed in the solution inside the medical container, and a precipitate could be confirmed.

以上の結果より、本発明の包装袋であれば、真空機などの専用の装置や器具を用いることなく、内部の空気を容易に脱気し、医療用容器に混注された溶剤の変質を抑制できる。
また、溶剤未混注の医療用容器の搬送に用いた後に、溶剤混注済み医療用容器の保管にも再使用可能である。
From the above results, with the packaging bag of the present invention, the internal air can be easily deaerated without using a dedicated device or instrument such as a vacuum machine, and the deterioration of the solvent mixed in the medical container can be suppressed. it can.
Further, after being used for transporting a medical container not mixed with solvent, it can be reused for storing a medical container mixed with solvent.

本発明の包装袋の一例を示す平面図である。It is a top view which shows an example of the packaging bag of this invention. 図1に示す包装袋の分解斜視図である。It is a disassembled perspective view of the packaging bag shown in FIG. 本発明の包装袋の他の例を示す図であり、(a)は平面図であり、(b)は(a)のA−A線で切断した断面図である。It is a figure which shows the other example of the packaging bag of this invention, (a) is a top view, (b) is sectional drawing cut | disconnected by the AA of (a). 本発明の包装袋の他の例を示す図であり、(a)は平面図であり、(b)および(c)は(a)のB−B線で切断した断面図であり、(d)は(b)に示す状態に対応し、かつ(a)のC−C線で切断した断面図であり、(e)は(c)に示す状態に対応し、かつ(a)のC−C線で切断した断面図である。It is a figure which shows the other example of the packaging bag of this invention, (a) is a top view, (b) And (c) is sectional drawing cut | disconnected by the BB line of (a), (d ) Corresponds to the state shown in (b) and is a cross-sectional view taken along line CC of (a), (e) corresponds to the state shown in (c), and C-- It is sectional drawing cut | disconnected by the C line. 本発明の包装袋の他の例を示す図であり、(a)は平面図であり、(b)は分解斜視図である。It is a figure which shows the other example of the packaging bag of this invention, (a) is a top view, (b) is a disassembled perspective view. 医療用容器の収容方法、及び薬剤混注済み医療用容器包装体の製造工程の一例を説明する図である。It is a figure explaining an example of the manufacturing method of the accommodation method of a medical container, and the medical container packaging body by which medicine mixing was carried out. 密封代が設けられた包装袋の一例を示す平面図である。It is a top view which shows an example of the packaging bag provided with the sealing allowance. 薬剤未混注の医療用容器の製造工程の一例を説明する工程図である。It is process drawing explaining an example of the manufacturing process of the medical container with no medicine mixed injection. 薬剤未混注の医療用容器の製造工程の他の例を説明する工程図である。It is process drawing explaining the other example of the manufacturing process of the medical container with no medicine mixed injection. 包装袋内の空気の排出方法の一例を示す説明図であり、(a)は圧縮前、(b)は圧縮後を示す図である。It is explanatory drawing which shows an example of the discharge method of the air in a packaging bag, (a) is a figure before compression, (b) is a figure which shows after compression. 医療用容器の一例を示す平面図である。It is a top view which shows an example of a medical container.

符号の説明Explanation of symbols

10:医療用容器包装袋、12:封止手段、13:逆止弁機構、20:医療用容器包装袋、30:医療用容器包装袋、50:薬剤混注済み医療用容器包装体、60:薬剤未混注の医療用容器包装体、100:医療用容器包装袋、200:医療用容器包装袋、300:医療用容器包装袋。

10: Medical container packaging bag, 12: Sealing means, 13: Check valve mechanism, 20: Medical container packaging bag, 30: Medical container packaging bag, 50: Medical mixed container package filled with medicine, 60: Medical container packaging body with unmixed medicine, 100: medical container packaging bag, 200: medical container packaging bag, 300: medical container packaging bag.

Claims (7)

ガスバリア性フィルムを用いて形成された医療用容器包装袋において、
再開封可能な封止手段と、当該医療用容器包装袋の内部から外部へ空気を排出し、かつ外部から内部への空気流入を防止する逆止弁機構とを有することを特徴とする医療用容器包装袋。
In a medical container packaging bag formed using a gas barrier film,
A medical device comprising: sealing means capable of re-sealing; and a check valve mechanism for discharging air from the inside to the outside of the medical container packaging bag and preventing air from flowing from the outside to the inside. Container packaging bag.
前記逆止弁機構の外気と接触する側の周縁部aを密封する密封代Aが設けられていることを特徴とする請求項1に記載の医療用容器包装袋。   The medical container packaging bag according to claim 1, wherein a sealing margin A is provided for sealing the peripheral edge portion a on the side of the check valve mechanism that contacts the outside air. 前記封止手段の外気と接触する側の周縁部bを密封する密封代Bが設けられていることを特徴とする請求項1または2に記載の医療用容器包装袋。   The medical container packaging bag according to claim 1 or 2, wherein a sealing margin B for sealing the peripheral edge b on the side of the sealing means in contact with the outside air is provided. 請求項1〜3のいずれかに記載の医療用容器包装袋を用い、封止手段を開封して薬剤が混注された医療用容器を収容した後、前記封止手段を封止し、当該医療用容器包装袋の内部の空気を逆止弁機構から外部へ排出することを特徴とする医療用容器の収容方法。   After using the medical container packaging bag according to any one of claims 1 to 3, the sealing means is opened and the medical container mixed with the medicine is accommodated, and then the sealing means is sealed, and the medical A method for containing a medical container, wherein the air inside the container packaging bag is discharged from the check valve mechanism to the outside. 請求項4に記載の医療用容器の収容方法により、薬剤が混注された医療用容器が包装されたことを特徴とする薬剤混注済み医療用容器包装体。   A medical container packaged with a medicine mixed-injected, wherein a medical container mixed with a medicine is packaged by the medical container housing method according to claim 4. 請求項1〜3のいずれかに記載の医療用容器包装袋を用い、前記封止手段および逆止弁機構を有さない一辺を切断して開封部を設け、該開封部から薬剤未混注の医療用容器を収容した後、開封部を密封することを特徴とする薬剤未混注の医療用容器包装体の製造方法。   Using the medical container packaging bag according to any one of claims 1 to 3, a side not having the sealing means and the check valve mechanism is cut to provide an opening portion, and a drug unmixed injection from the opening portion A method for producing a medical container package containing unmixed medicines, wherein after opening the medical container, the opening is sealed. ガスバリア性フィルムを用いて形成された医療用容器包装袋に、薬剤未混注の医療用容器が包装された薬剤未混注の医療用容器包装体であって、
前記医療用容器包装袋は、再開封可能な封止手段と、医療用容器包装袋の内部から外部へ空気を排出し、かつ外部から内部への空気流入を防止する逆止弁機構とを有し、かつ、前記封止手段および逆止弁機構の外気と接触する側の周縁部が密封されたことを特徴とする薬剤未混注の医療用容器包装体。

A medical container packaging body with unmixed medicine in which a medical container with unmixed medicine is packaged in a medical container packaging bag formed using a gas barrier film,
The medical container packaging bag has sealing means that can be re-sealed, and a check valve mechanism that discharges air from the inside of the medical container packaging bag to the outside and prevents air from flowing from the outside to the inside. And the peripheral part of the side in contact with the outside air of the sealing means and the check valve mechanism is sealed.

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Cited By (7)

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JP2012153405A (en) * 2011-01-26 2012-08-16 Dainippon Printing Co Ltd Packing bag
WO2014104220A1 (en) * 2012-12-28 2014-07-03 ニプロパッチ株式会社 Packaging
JP2014210749A (en) * 2013-04-20 2014-11-13 株式会社シビルテック Active ingredient-diffusing tool, and sheet filled with liquid body
JP2014534932A (en) * 2011-10-18 2014-12-25 メニコン シンガポール ピーティーイー. リミテッド Contact lens auxiliary packaging and auxiliary packaging method
JP6168328B1 (en) * 2016-08-30 2017-07-26 共栄機械株式会社 Bag making device with check valve
JP2017145028A (en) * 2016-02-17 2017-08-24 株式会社フジシール Package containing granular material and packaging bag for granular material
CN111717534A (en) * 2020-06-22 2020-09-29 长沙银腾塑印包装有限公司 High-barrier recyclable packaging product

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JP2002193273A (en) * 2000-12-22 2002-07-10 R:Kk Compression storage bag
JP2006142592A (en) * 2004-11-18 2006-06-08 Matsushita Electric Works Ltd Volume reducing method of waste
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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012153405A (en) * 2011-01-26 2012-08-16 Dainippon Printing Co Ltd Packing bag
JP2014534932A (en) * 2011-10-18 2014-12-25 メニコン シンガポール ピーティーイー. リミテッド Contact lens auxiliary packaging and auxiliary packaging method
WO2014104220A1 (en) * 2012-12-28 2014-07-03 ニプロパッチ株式会社 Packaging
JPWO2014104220A1 (en) * 2012-12-28 2017-01-19 ニプロパッチ株式会社 Package
JP2014210749A (en) * 2013-04-20 2014-11-13 株式会社シビルテック Active ingredient-diffusing tool, and sheet filled with liquid body
JP2017145028A (en) * 2016-02-17 2017-08-24 株式会社フジシール Package containing granular material and packaging bag for granular material
JP6168328B1 (en) * 2016-08-30 2017-07-26 共栄機械株式会社 Bag making device with check valve
JP2018034890A (en) * 2016-08-30 2018-03-08 共栄機械株式会社 Making-bag device with nonreturn valve
CN111717534A (en) * 2020-06-22 2020-09-29 长沙银腾塑印包装有限公司 High-barrier recyclable packaging product

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