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JP4365948B2 - Infusion bag - Google Patents

Infusion bag Download PDF

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Publication number
JP4365948B2
JP4365948B2 JP23389499A JP23389499A JP4365948B2 JP 4365948 B2 JP4365948 B2 JP 4365948B2 JP 23389499 A JP23389499 A JP 23389499A JP 23389499 A JP23389499 A JP 23389499A JP 4365948 B2 JP4365948 B2 JP 4365948B2
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Japan
Prior art keywords
seal portion
infusion bag
infusion
bag
width
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JP2001054553A (en
Inventor
知彦 江崎
功 大竹
仁 斎藤
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Hosokawa Yoko KK
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Hosokawa Yoko KK
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261Flexible containers having several compartments
    • B65D81/3266Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Package Specialized In Special Use (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Description

【0001】
【発明の属する技術分野】
本発明はプラスチック製シートで作られたへん平な多室からなる輸液バッグに関する。特に弱シール部により複数室に分割され、使用時に液体収容部を加圧して弱シール部分を剥離させ、薬液を混合する輸液バッグであって、誤って落下しても該剥離部の破損のおそれのない輸液バッグに関する。
【0002】
【従来の技術】
医療用輸液バッグが使用される一分野においては、輸液する直前に、複数種の薬液を混合して輸液する場合があり、該輸液用薬液の混合、調製作業時における異物の混入、雑菌の侵入等の防止のできる衛生防疫機能を備えた輸液バッグの出現が望まれてきたが、この対策として筒状合成樹脂製フィルムによって形成された袋状容器内壁面を弱シールして複数室に区画し、各室に混合用の薬液または薬剤を予め充填して置き、輸液が必要な時にこれら区画のシール部を剥離又は破壊し、輸液バッグ全体を一室とすることにより、複数種の薬液を無菌的環境下に混合することができるようにした輸液バッグが知られている。
【0003】
このような形式の輸液バッグとしては、分離されている薬液を混合して輸液を行うまでは、各混合用薬液を確実に分離して置く必要性から、弱シール部は輸液バッグに必要な通常の取扱工程、例えば洗浄、分注、滅菌等の工程では簡単に剥離するようなものであってはならないが、薬液を混合して輸液という本来の目的のために使用しようとするときは、手によるバッグを加圧する等適切な手段によって、輸液バッグ本体の強シール部の剥離を起こすことなく、上記弱シール部のみ剥離又は破壊できるという特性が要求される。
【0004】
このような要求を満たすための輸液バッグとしては種々のものが提案されている(例えば、特開明63−19149号公報、特開平1−240469号公報、特開平2−4671号公報、特開平6−39018号公報等)が、従来のものは、上記弱シール部の形成手段として、相溶性の高くない2種類の合成樹脂を混合して成形した袋状容器を用い、該容器内面を通常の熱接着させることにより高い接着強度までは得られないイージーピールタイプとしたものや、融着及び剥離の機能を受け持つ層として輸液バッグ内面に別フィルムをラミネートしたタイプのものが代表例として挙げられる。
【0005】
従来輸液バッグは、薬液の輸液中における易偏平化特性の他、高生産性等の要求から、主としてポリエチレンとかエチレン−酢酸ビニールコポリマー等の比較的剛性の低い合成樹脂が使用されてきた。これらの合成樹脂はインフレーション成形加工とか、フラットな帯状フィルムの折り畳み及び熱接着加工により筒状フィルムに成形され、これを所望の長さに切断し、上下両切断口の少なくとも一方は、合成樹脂製薬液充填用又は取り出し用口部材と共に、高い気密性、液密性、非剥離性の熱接着が要求される。通常は高温、高圧の条件下、広幅の強シール性熱接着帯域が形成されている。この熱接着に当たっては、剛性の比較的低い上記合成樹脂の場合であっても、筒状フィルムの長さ方向に沿う両側端部の折り畳み部分は、合成樹脂特有の弾性回復力があり、この折り畳み部分は使用合成樹脂の融点をも考慮し、かなりの高温、高圧、長加圧時間でもって熱融着をしなければ液漏れが生ずる。
【0006】
本発明にかかる輸液バッグは、上下端部間の中間に少なくとも1個の区画シール部を有するものであるが、該区画シール部のうち両側端部分はフィルムの折り畳み部の弾性回復特性に基づき、完全なシールをするためには可なり苛酷な条件が要求され、その結果、前記袋状容器上下端部の強シールに近い強力なシール状態にならざるを得ない。従って、この部分のシールは、区画シール部の中央部分の弱シール部と同様の、輸液作業時に剥離させることのできる弱シール状態にすることは困難である。従来においても、区画シールの両側端は輸液作業前の薬液混合時にも非剥離性の強シール部とし、該両側端の強シール部に挟まれた中央部分のみ剥離性の弱シール部とする形態が採られてきた。
【0007】
しかし、従来のこの強シール部の形状は、中央部分にある細幅で帯状の弱シール部が両側端の折り目に向かって連続的に拡幅した形状、具体的には例えば、特開平6−39018号公報(図2参照)に開示されているように、直線状弱シール部2がその上下対称に、しかも輸液バッグ1内方に凹である曲線を描いて連続的に拡幅した形状をとり、この拡幅した形状部分が強シール部3に相当する区画シール部となっていた。
当然のことであるが、この形状の強シール部3の場合もまた両側端部の折り日部分を含むため、中央部分の弱シール部2に比べ、かなり厳しいシール条件が採られているものと考えられ、例えば高温加圧、複数回加圧、長時間加圧等の条件が考えられる。また、上記のごときこのタイプのシール部では、袋内方に凹の曲線であるため、輸液時における薬剤の滞留が起こりやすく、全薬剤の完全輸液が期待できない問題点を有する。
【0008】
前記図2に示される輸液バッグの強シール部3は、弱シール部2の連続的延長線上にあるため、弱シール部2との境界は尖鋭な突起形状になっており、薬液混合のために弱シール部2を剥離又は破壊した後において誤って落袋させると、この突起形状の境界に瞬間的引張伸長応力が集中し易く、当該部分に破壊とかピンホールが発生し易い欠点を有する。
【0009】
【発明が解決しようとする課題】
本発明の目的は、上記した中央付近で区画された従来の輸液バッグの弱シール部を剥離した後の破袋の問題点を解消しようとするものである。より具体的には、区画シール部の弱シール部を剥離し、薬液混合後輸液前に、輸液バッグの洗浄、分注、或は滅菌等の工程で僅かの内圧が掛かったり、或いは誤って落袋して急激に内圧がかかっても、弱シール部と接続していた場所の強シール部に破裂的な応力集中が発生するおそれがなく、従ってこの部分における破裂、ピンホールの発生を極力防止でき、しかも輸液作業時に薬液が滞留することなく容易に落下できる形状の区画シール形状、特にそれを構成する強シール部の好ましい形状を見出すことにあり、更にはそのような好ましい区画シール部を効率よく形成しうる輸液バッグを提供しようとするものである。
【0010】
【課題を解決するための手段】
上記の課題を解決するために本発明者らは鋭意研究をした結果、従来の区画シール部における強シール部の形状を特定の形状にすることにより解決できることを見出し、本発明を完成するに至った。
即ち本発明の要旨は、以下の通りである。
[1] シール部により複数室に区画され、各室に異なる薬剤が充填され、相互に混合されることなく輸送され、使用時にはこれらの薬剤を混合できる輸液バッグであって、上記シール部がバッグ両側端部分の強シール部と、それに挟まった中央部の帯状の弱シール部とからなり、該強シール部は一定の幅で該弱シール部の幅よりも長くその上下方向に対称的に直交して設けられたことを特徴とする輸液バッグ、
[2] 中空状フィルムから製造されたことを特徴とする上記[1]に記載の輸液バッグ、及び
[3] 強シール部の長さが弱シール幅の1.1〜3倍、幅が0.3〜2倍である上記[1]または[2]に記載の輸液バッグ、を開発することにより上記の課題を解決した。
【0011】
【発明の実施の形態】
本発明の輸液バッグに使用する素材としては、生体に有害な物質を溶出しない熱可塑性プラスチックで軟質のものが好ましい。高圧法低密度ポリエチレン、直鎖状低密度ポリエチレン、高密度ポリエチレン、ポリプロピレンなど、特に前3種の樹脂またはそれらの混合物が好ましく使用されている。
【0012】
以下上下2室からなる輸液バッグである図1を参照して本発明を説明するが、3室以上あっても構わない。
輸液バッグ1の成形前の中空状のフィルムの長さ方向に沿う両側端には折り目が形成され、下両端はそれぞれの切断口に薬液充填用口部材7及び同取り出し用口部材8を取り付け、中空状のフィルムと共に液密に接着された強シール部分5及び6が形成された輸液バッグが得られる。
該輸液バッグの上下方向の中間部には、その幅方向に区画シール部9が形成される。該区画シール部9は弱シール部2と強シール部3とから構成されている。なおこの区画シール部9の形成により、輸液バッグ1は上部薬剤室4と下部薬剤室4’に分割された輸液バッグ1となり、両室に充填された薬剤は、輸液作業まで混合されることなく隔離状態におかれる。
【0013】
本発明にいう弱シールとは、輸液作業を行うまでの輸液バッグの種々の取扱時には簡単には剥離せず、区画された各室内に封入された混合用薬剤はそのまま保存することができるシールであり、輸液作業時に入る直前の薬剤混合時に、区画室の内圧を意図的に所定の値以上にするため、手等により薬液充填の薬剤室を圧迫すれば輸液バッグ内壁面において該弱シール部分全体にわたり均一且つ安定した剥離できるシールであり、輸液バッグの切断口部の強シール部5及び6のごとく輸液バッグ自体の形成に必要でしかも剥離することは許されないシール部分の剥離強度に比較してかなり低い融着強度しか有しないシールを意味するものであり、その具体的シール強度又はその範囲は、輸液バッグの形状、大きさ、混合用薬剤量等により適宜設定される。
【0014】
輸液バッグ1は中空状のフィルムを偏平に折り畳んで製造されるものであり、その両側端は中空状のフィルムの折り目であるが、該折り目は合成樹脂特有の弾性回復性を有し、折り日部分以外の部分と同様の条件でヒートシールをしても他の部分と同じ密封状態は得難い。即ち、折り目部分はかなり高温、高圧、長時間の条件下でシールしなければ液密なシールはできない。これに対して、折り目以外の部分はこれよりも弱い条件でも液密にシールすることができる。
しかも、この区画シール部9には輸液作業時に剥離又は破壊可能な弱シール性を有する部分が必要がある。本発明はこの区画シール部9を、両側端の折り目部分に薬剤混合時に剥離等を起こさない特定の強シール部3を形成し、該両端の強シール部3に挟まれた部分を弱シール部2とし、しかも該弱シール部2を剥離又は破壊して開口した場合に、弱シール部2と相接していた部分の強シール部3に破裂又はピンホールを発生させない要求を満たそうとするものである。
【0015】
本発明においては区画シール部9の強シール部3は、弱シール部の両端部分に一定の幅で弱シール部2の幅よりも長く、その上下方向に対称的にかつ直交して設けられる。
強シール部3の長さ(上下方向)は、通常弱シール部2の幅(上下方向)の1.1〜5倍、好ましくは1.2〜3倍程度である。強シール部3の長さがこれより長くとも剥離、破袋、ピンホールに対しては特に問題がないが、輸液バッグ1の上下方向の柔軟性が失われるので余り長くすることは好ましくない。
また強シール部3の幅(横方向)は、弱シール部2の幅の0.2〜2倍程度、好ましくは0.3〜1.5倍程度である。この幅も輸液バッグの取扱性のために弱シール部2の幅の2倍より大きくすることは好ましくない。
【0016】
該強シール部3のシール強度は、そのシール強度において弱シール部と大きい差がなければならないが、そのため強シール部は表裏に綾目形状又は平目形状の凹凸を互いに背中合わせに形成したシール方式などをとることが好ましい。
また弱シール部2の剥離強度は、輸液バッグ内に収納された複数種の薬剤を適切に混合できるように所望の範囲に管理されたものでなければならないが、その非剥離状態を保つには、輸液バッグの長さ、幅、薬剤量により決まる値の範囲であり、具体的な特定値としては表すことはできないが、通常は輸液バッグ内圧が0.1〜0.5Kgf/cm2 に昇圧されたときに剥離し始める耐圧強度が好ましい。
このように、弱シール部2の幅よりも長いかつ一定幅の強シール部3は、対称的に弱シール部2の幅全体及びその上下に延長して直交して設けられているが、理由は解明できなかったが弱シール部と強シール部の交点をストレート形状にすることにより、弱シール部を剥離後の破袋は回避でき、落袋強度が大きく改善できた。
【0017】
【実施例】
次に実施例及び比較例で本発明を説明する。
(実施例1〜3、比較例1〜2)
厚さ250ミクロン、折径190mmの線状低密度ポリエチレン製中空状フィルムを900mmに切断し、上下開口部を口部材とともにヒートシールして図1に示すような輸液バッグを作成した。
輸液バッグの長さ方向中央部に、区画シールを形成するため、ヒートシールバーを使用し、温度:120℃、押圧力:4kg/cm2 、押圧時間:4秒で押圧し、幅10mm×長さ190mmの弱シール部を形成した。更にその弱シール部の両端部に、シール部が重なるように表1に示す長さ及び幅のヒートシールバーをあてがって強シール部を形成した。強シール部のヒートシール条件は温度:145℃、押圧力:4kg/cm2 、押圧時間2.5秒である。
次いで該輸液バッグの上下2室に合計1000mlの水を充填し、各口部材を封じて115℃、30minのレトルト処理をした後、弱シール部部を剥離し、上下2室を連通させ、輸液バッグを4℃に保持した後、1.5mの高さから連続5回落下させた時の破袋するまでの落下回数の平均を測定した。結果を表1に示す。
比較のため、図2に示すような区画シール部を設けた輸液バッグを実施例と同様にテストした。結果を表1に示す。
【0018】
【表1】

Figure 0004365948
Figure 0004365948
実施例
1 ストレート 15mm 4mm 5回で破袋せず
2 ストレート 15mm 4mm 5回で破袋せず
3 ストレート 30mm 8mm 5回で破袋せず
比較例
1 内方に凹 半径15mm 4mm 0.7回
2 内方に凹 半径15mm 8mm 0.4回
【0019】
【発明の効果】
本発明はプラスチックフィルムで作られた複数室からなる輸液バッグ、特に弱シール部により複数室に分割され、使用時に液体収容部を加圧して弱シールを剥離し、薬剤を混合する輸液バッグであって、落下や過度の加圧に対して該剥離部の破損のおそれのない取扱の安全性の高い輸液バッグである。
本発明の輸液バッグは、区画シール部の弱シール部を剥離し、薬液混合後、輸液前に輸液バッグの洗浄、分注、或は滅菌等の工程で余分の内圧がかかったり、或いは誤って落袋して急激に内圧がかかっても、弱シール部と接続していた場所の強シール部に破裂的な応力集中が発生するおそれがなく、従ってこの部分における破裂、ピンホールの発生を極力防止でき、しかも輸液作業時に薬液が滞留することなく容易に落下できる形状の区画シール形状を有するので有利である。
【図面の簡単な説明】
【図1】本発明の輸液バッグの正面図である。
【図2】従来の輸液バッグの一例の正面図である。
【符号の説明】
1 輸液バッグ
2 弱シール部
3 強シール部
4、4’ 薬剤室
5 強シール部
6 強シール部
7 薬剤用口部材
8 薬剤用口部材
9 区画シール[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an infusion bag comprising a flat multi-chamber made of a plastic sheet. In particular, it is an infusion bag that is divided into a plurality of chambers by a weak seal part, pressurizes the liquid storage part during use, peels off the weak seal part, and mixes the chemical solution, and the peel part may be damaged even if it is accidentally dropped It is related with the infusion bag without.
[0002]
[Prior art]
In one field where medical infusion bags are used, just before infusion, multiple types of medicinal liquids may be mixed and transfused. Mixing of the infusion medicinal liquids, contamination of foreign substances during preparation work, invasion of germs The emergence of an infusion bag with a hygiene and quarantine function that can prevent such problems has been desired, but as a countermeasure against this, the inner wall surface of a bag-like container formed by a cylindrical synthetic resin film is weakly sealed and partitioned into multiple chambers. Each chamber is pre-filled with chemicals or drugs for mixing, and when infusion is needed, the seals of these compartments are peeled or destroyed, and the entire infusion bag is made into one chamber, so that multiple types of medicinal solutions can be aseptic Infusion bags are known which can be mixed in a typical environment.
[0003]
In this type of infusion bag, the weakly sealed part is usually necessary for an infusion bag because it is necessary to separate each medicinal solution for mixing until the separated medicinal solution is mixed and infused. In the handling process, such as washing, dispensing, sterilization, etc., it should not be easily peeled off. However, when mixing chemicals and using them for the original purpose of infusion, A characteristic that only the weak seal portion can be peeled or broken without causing peeling of the strong seal portion of the infusion bag body by an appropriate means such as pressurizing the bag is required.
[0004]
Various infusion bags for satisfying such a demand have been proposed (for example, JP-A-63-19149, JP-A-1-240469, JP-A-2-4671 and JP-A-6-6). However, the conventional one uses a bag-like container formed by mixing two types of synthetic resins that are not highly compatible as the means for forming the weak seal portion. Typical examples include an easy peel type in which high adhesive strength cannot be obtained by heat bonding, and a type in which another film is laminated on the inner surface of the infusion bag as a layer responsible for fusion and peeling.
[0005]
Conventional infusion bags have been mainly made of synthetic resins having relatively low rigidity such as polyethylene and ethylene-vinyl acetate copolymer because of demands for high productivity as well as easy flattening characteristics of medicinal solutions during infusion. These synthetic resins are formed into a tubular film by inflation molding, flat belt-like film folding and thermal bonding, and this is cut into a desired length. At least one of the upper and lower cut ports is a synthetic resin pharmaceutical. A high airtightness, liquid tightness, and non-peelable thermal bonding are required together with the liquid filling or taking out port member. Usually, a wide, strong-sealable thermal bonding zone is formed under high temperature and high pressure conditions. In this thermal bonding, even in the case of the above-mentioned synthetic resin having a relatively low rigidity, the folded portions at both end portions along the length direction of the tubular film have an elastic recovery force unique to the synthetic resin. In consideration of the melting point of the synthetic resin used, the portion will leak if it is not heat-sealed at a considerably high temperature, high pressure and long pressurization time.
[0006]
The infusion bag according to the present invention has at least one partition seal portion in the middle between the upper and lower ends, but both end portions of the partition seal portion are based on the elastic recovery characteristics of the folded portion of the film, In order to achieve a perfect seal, extremely severe conditions are required, and as a result, a strong sealing state close to a strong seal at the upper and lower ends of the bag-like container has to be obtained. Therefore, it is difficult for the seal at this portion to be in a weak seal state that can be peeled off during the infusion operation, similar to the weak seal portion at the center of the partition seal portion. Conventionally, both side ends of the partition seal are non-peelable strong seal portions even during mixing of the chemical solution before the infusion operation, and only the central portion sandwiched between the strong seal portions on both side ends is a peelable weak seal portion. Has been adopted.
[0007]
However, the conventional shape of the strong seal portion is a shape in which a narrow, band-like weak seal portion at the center portion is continuously widened toward the folds at both ends, specifically, for example, JP-A-6-39018. As disclosed in the Gazette (see FIG. 2), the linear weak seal portion 2 has a shape that is continuously widened by drawing a curved line that is concave in the vertical direction and inwardly in the infusion bag 1, This widened shape portion was a partition seal portion corresponding to the strong seal portion 3.
As a matter of course, the strong seal portion 3 of this shape also includes the folding date portions at both end portions, so that considerably strict seal conditions are taken compared to the weak seal portion 2 at the center portion. For example, conditions such as high-temperature pressurization, multiple pressurization, and long-time pressurization are conceivable. Further, since the seal portion of this type as described above has a concave curve inward of the bag, the drug is liable to stay at the time of infusion, and a complete infusion of all the drugs cannot be expected.
[0008]
Since the strong seal portion 3 of the infusion bag shown in FIG. 2 is on the continuous extension line of the weak seal portion 2, the boundary with the weak seal portion 2 has a sharp protrusion shape for mixing the chemical solution. If the bag is accidentally dropped after the weak seal portion 2 is peeled or broken, the instantaneous tensile elongation stress tends to concentrate on the boundary of the projection shape, and there is a defect that the portion is liable to break or pinhole.
[0009]
[Problems to be solved by the invention]
An object of the present invention is to solve the problem of bag breakage after peeling off the weak seal portion of a conventional infusion bag partitioned near the center. More specifically, the weak seal part of the compartment seal part is peeled off, and a slight internal pressure is applied or mistakenly dropped in the process of washing, dispensing or sterilizing the infusion bag before infusion after mixing the chemicals. There is no risk of bursting stress concentration in the strong seal part where it was connected to the weak seal part even if the bag is suddenly subjected to internal pressure. Therefore, the burst and pinholes in this part are prevented as much as possible. In addition, the object is to find a partition seal shape that can be easily dropped without causing a chemical solution to stay during the infusion operation, and in particular, to find a preferable shape of the strong seal portion that constitutes it. It is intended to provide an infusion bag that can be well formed.
[0010]
[Means for Solving the Problems]
In order to solve the above problems, the present inventors have intensively researched and found that it can be solved by making the shape of the strong seal portion in the conventional partition seal portion into a specific shape, and the present invention has been completed. It was.
That is, the gist of the present invention is as follows.
[1] An infusion bag that is partitioned into a plurality of chambers by a seal portion, filled with different drugs in each chamber, transported without being mixed with each other, and capable of mixing these drugs at the time of use, wherein the seal portion is a bag It consists of a strong seal part at both ends and a belt-like weak seal part sandwiched between them, and the strong seal part has a constant width and is longer than the width of the weak seal part. An infusion bag characterized by being provided as
[2] The infusion bag according to [1] above, which is manufactured from a hollow film, and [3] The length of the strong seal portion is 1.1 to 3 times the weak seal width and the width is 0 The above-mentioned problems were solved by developing the infusion bag according to [1] or [2], which is 3 to 2 times.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
The material used for the infusion bag of the present invention is preferably a soft thermoplastic material that does not elute substances harmful to the living body. High pressure method low density polyethylene, linear low density polyethylene, high density polyethylene, polypropylene and the like, in particular, the former three kinds of resins or a mixture thereof are preferably used.
[0012]
Hereinafter, the present invention will be described with reference to FIG. 1, which is an infusion bag consisting of two upper and lower chambers, but there may be three or more chambers.
A crease is formed at both side ends along the length direction of the hollow film before molding of the infusion bag 1, and the lower end is attached with the chemical solution filling port member 7 and the same outlet port member 8 at the respective cutting ports, An infusion bag in which strong seal portions 5 and 6 adhered in a liquid-tight manner together with a hollow film is formed.
A partition seal portion 9 is formed in the width direction of the intermediate portion in the vertical direction of the infusion bag. The partition seal portion 9 includes a weak seal portion 2 and a strong seal portion 3. By forming the partition seal portion 9, the infusion bag 1 becomes the infusion bag 1 divided into the upper medicine chamber 4 and the lower medicine chamber 4 ′, and the medicine filled in both chambers is not mixed until the infusion work. Placed in isolation.
[0013]
The weak seal referred to in the present invention is a seal that does not easily peel off during various handling of the infusion bag until the infusion operation is performed, and the mixing medicine sealed in each compartmented room can be stored as it is. Yes, when mixing the drug just before entering the infusion operation, the internal pressure in the compartment is intentionally set to a predetermined value or more. Compared to the peel strength of the seal portion that is necessary for the formation of the infusion bag itself, such as the strong seal portions 5 and 6 at the cut opening portion of the infusion bag, and is not allowed to be peeled off. This means a seal having a considerably low fusion strength, and the specific seal strength or range thereof is appropriately set depending on the shape, size, amount of drug for mixing, etc. It is.
[0014]
The infusion bag 1 is manufactured by flatly folding a hollow film, and both side ends thereof are folds of a hollow film, and the folds have elastic recovery characteristic unique to synthetic resins, Even if heat sealing is performed under the same conditions as those of the other parts, it is difficult to obtain the same sealed state as the other parts. That is, the crease part cannot be liquid-tightly sealed unless it is sealed under conditions of considerably high temperature, high pressure and long time. On the other hand, portions other than the folds can be liquid-tightly sealed even under weaker conditions.
In addition, the partition seal portion 9 needs to have a weakly sealable portion that can be peeled off or destroyed during the infusion operation. In the present invention, the partition seal portion 9 is formed with a specific strong seal portion 3 which does not cause peeling or the like at the time of mixing the medicines at the crease portions at both ends, and the portion sandwiched between the strong seal portions 3 at both ends is the weak seal portion. 2 and when the weak seal portion 2 is peeled or broken and opened, it tries to satisfy the requirement not to generate a rupture or pinhole in the strong seal portion 3 that is in contact with the weak seal portion 2 Is.
[0015]
In the present invention, the strong seal portions 3 of the partition seal portion 9 are provided at both end portions of the weak seal portion with a constant width and longer than the width of the weak seal portion 2, and symmetrically and perpendicularly to the vertical direction.
The length (vertical direction) of the strong seal portion 3 is usually 1.1 to 5 times, preferably about 1.2 to 3 times the width (vertical direction) of the weak seal portion 2. Even if the length of the strong seal portion 3 is longer than this, there is no particular problem with respect to peeling, bag breaking, and pinholes, but since the flexibility of the infusion bag 1 in the vertical direction is lost, it is not preferable to make it too long.
Further, the width (lateral direction) of the strong seal portion 3 is about 0.2 to 2 times, preferably about 0.3 to 1.5 times the width of the weak seal portion 2. It is not preferable to make this width larger than twice the width of the weak seal portion 2 for handling of the infusion bag.
[0016]
The seal strength of the strong seal portion 3 must be greatly different from that of the weak seal portion in the seal strength. For this reason, the strong seal portion has a twill shape or flat shape unevenness formed on the back and back, etc. It is preferable to take
In addition, the peel strength of the weak seal portion 2 must be controlled within a desired range so that a plurality of types of drugs stored in the infusion bag can be appropriately mixed. This is a range of values determined by the length, width, and amount of drug of the infusion bag, and cannot be expressed as a specific specific value. Usually, the infusion bag internal pressure is increased to 0.1 to 0.5 kgf / cm 2 . The pressure strength that begins to peel when applied is preferred.
As described above, the strong seal portion 3 longer than the width of the weak seal portion 2 and having a constant width is provided symmetrically extending perpendicularly to the entire width of the weak seal portion 2 and above and below. However, by making the intersection of the weak seal part and the strong seal part straight, it was possible to avoid the bag breaking after peeling off the weak seal part, and the bag drop strength could be greatly improved.
[0017]
【Example】
Next, the present invention will be described with reference to examples and comparative examples.
(Examples 1-3, Comparative Examples 1-2)
A linear low density polyethylene hollow film having a thickness of 250 microns and a fold diameter of 190 mm was cut into 900 mm, and the upper and lower openings were heat-sealed together with a mouth member to prepare an infusion bag as shown in FIG.
A heat seal bar is used to form a compartment seal at the center in the length direction of the infusion bag. Temperature: 120 ° C., pressing force: 4 kg / cm 2 , pressing time: 4 seconds, width 10 mm × length A weak seal portion having a thickness of 190 mm was formed. Further, a heat seal bar having a length and width shown in Table 1 was applied to both ends of the weak seal portion so that the seal portion overlapped to form a strong seal portion. The heat seal conditions of the strong seal part are temperature: 145 ° C., pressing force: 4 kg / cm 2 , and pressing time of 2.5 seconds.
Next, the upper and lower chambers of the infusion bag are filled with a total of 1000 ml of water, each mouth member is sealed and subjected to a retort treatment at 115 ° C. for 30 min, the weak seal portion is peeled off, and the upper and lower chambers are communicated with each other. After holding the bag at 4 ° C., the average number of times of dropping until the bag was broken when it was dropped continuously from the height of 1.5 m five times was measured. The results are shown in Table 1.
For comparison, an infusion bag provided with a compartment seal as shown in FIG. 2 was tested in the same manner as in the example. The results are shown in Table 1.
[0018]
[Table 1]
Figure 0004365948
Figure 0004365948
Example 1 Straight 15 mm 4 mm 5 times without breaking the bag 2 Straight 15 mm 4 mm 5 times without breaking the bag 3 Straight 30 mm 8 mm 5 times without breaking the bag Comparative Example 1 Inward radius 15 mm 4 mm 0.7 times 2 Inward concave radius 15mm 8mm 0.4 times [0019]
【The invention's effect】
The present invention is an infusion bag comprising a plurality of chambers made of a plastic film, particularly an infusion bag that is divided into a plurality of chambers by a weak seal portion, pressurizes the liquid storage portion during use and peels off the weak seal, and mixes the drug. Thus, it is an infusion bag with high handling safety that does not cause the peeling part to be damaged due to dropping or excessive pressurization.
The infusion bag of the present invention peels off the weak seal part of the compartment seal part, and after mixing the chemical solution, before the infusion, excessive internal pressure is applied in the process of washing, dispensing, or sterilization of the infusion bag, or by mistake. Even if the bag is dropped and sudden internal pressure is applied, there is no risk of bursting stress concentration in the strong seal part where it was connected to the weak seal part. This is advantageous because it has a partition seal shape that can be prevented and can be easily dropped without stagnation of the chemical during the infusion operation.
[Brief description of the drawings]
FIG. 1 is a front view of an infusion bag according to the present invention.
FIG. 2 is a front view of an example of a conventional infusion bag.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Infusion bag 2 Weak seal part 3 Strong seal part 4, 4 'Drug chamber 5 Strong seal part 6 Strong seal part 7 Drug mouth member 8 Drug mouth member 9 Compartment seal

Claims (3)

シール部により複数室に区画され、各室に異なる薬剤が充填され、相互に混合されることなく輸送され、使用時にはこれらの薬剤を混合できる輸液バッグであって、上下両端が強シールされ、両側端は折り目が形成され、上記シール部がバッグ両側端部分の強シール部と、それに挟まった中央部の帯状の内壁同士が直接シールされた弱シール部とからなり、該強シール部は一定の幅(横方向)で、弱シール幅の0.2〜2倍、長さ(上下方向)は該弱シール部の幅の1.1〜5倍で、強シール部と弱シール部は対称的に直交して設けられたことを特徴とする輸液バッグ。Is partitioned into a plurality chambers by a seal portion, is filled with different drugs in each chamber, is transported without being mixed with one another, a transfusion bag which can mix these agents at the time of use, the upper and lower ends are strong seal, both sides The end is formed with a crease, and the seal portion is composed of a strong seal portion at both side end portions of the bag and a weak seal portion in which the central belt-like inner walls sandwiched between the weak seal portions are directly sealed . The width (lateral direction) is 0.2 to 2 times the weak seal width, the length (vertical direction) is 1.1 to 5 times the width of the weak seal portion, and the strong seal portion and the weak seal portion are symmetrical. An infusion bag characterized by being provided orthogonally to. 強シール部は一定の幅(横方向)で、弱シール幅の0.3〜1.5倍、長さ(上下方向)は該弱シール部の幅の1.2〜3倍である請求項1に記載の輸液バッグ。  The strong seal portion has a constant width (lateral direction), 0.3 to 1.5 times the weak seal width, and the length (vertical direction) is 1.2 to 3 times the width of the weak seal portion. The infusion bag according to 1. 中空状フィルムから製造されたことを特徴とする請求項1または2に記載の輸液バッグ。  The infusion bag according to claim 1 or 2, wherein the infusion bag is manufactured from a hollow film.
JP23389499A 1999-08-20 1999-08-20 Infusion bag Expired - Lifetime JP4365948B2 (en)

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