JP2001314484A - Medical plural chamber container and manufacturing method thereof - Google Patents
Medical plural chamber container and manufacturing method thereofInfo
- Publication number
- JP2001314484A JP2001314484A JP2000134561A JP2000134561A JP2001314484A JP 2001314484 A JP2001314484 A JP 2001314484A JP 2000134561 A JP2000134561 A JP 2000134561A JP 2000134561 A JP2000134561 A JP 2000134561A JP 2001314484 A JP2001314484 A JP 2001314484A
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- Prior art keywords
- chamber
- medical
- container
- chamber container
- chambers
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、異種の薬液等を隔
離して別々の室に保存しておき、使用時に各室間を連通
して薬液等を混合し、均一溶液とする方式の医療用複室
容器及びその製造方法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical system in which different kinds of liquid medicines and the like are isolated and stored in separate chambers, and when used, the medicines and the like are mixed by communicating between the chambers to form a uniform solution. The present invention relates to a multi-chamber container for use and a method for producing the same.
【０００２】[0002]
【従来の技術】従来、異種の薬液等を隔離して別々の室
に保存しておき、使用時に各室間を連通して薬液等を混
合し、均一溶液とする方式の医療用複室容器として、特
開平６−３９０１８号の容器が提案されている。前記容
器は、プラスチック製の多層シートからなる偏平な容器
の内部が、剥離可能に内壁接着帯及びその両端に続く強
溶着部によってシールされ、複数の室が形成されたもの
で、強溶着部に衝撃緩和用の溶着領域が設けられている
ものである。2. Description of the Related Art Conventionally, different types of medical solutions and the like are isolated and stored in separate chambers, and at the time of use, the medical chambers are communicated between the chambers to mix the medical solutions and the like to form a uniform solution. A container disclosed in JP-A-6-39018 has been proposed. In the container, the inside of a flat container made of a plastic multilayer sheet is releasably sealed by an inner wall adhesive band and a strong welding portion following both ends thereof, and a plurality of chambers are formed. A welding area for impact reduction is provided.
【０００３】また、別の容器として特開平１１−１６９
４３２号が提案されている。前記容器は、各室を区画し
ている境界部において対向し合うプラスチックフィルム
の内面側に、易剥離性コーティング材料を塗布してから
ヒートシンクすることにより、剥離可能に接合したウイ
ークシール部を有するものである。As another container, Japanese Patent Application Laid-Open No. 11-169
No. 432 has been proposed. The container has a weak seal portion which is peelably joined by applying an easily peelable coating material to the inner surface side of a plastic film facing each other at a boundary portion dividing each chamber and then applying a heat sink. It is.
【０００４】しかしながら、特開平６−３９０１８号、
特開平１１−１６９４３２号に開示されている医療用複
室容器にあっては、隔離手段として剥離可能な溶着領域
が設けられているが、ヒートシールにより比較的弱い強
度でシールされているので、その剥離は比較的弱い力で
行われる。またシール強度はシートの偏肉、内層の樹脂
のブレンド比、ヒートシールの温度制御等に大きく支配
されるので、その値のばらつきが大きくなり、剥離に要
する力も容器毎に微妙に異なる。However, Japanese Patent Application Laid-Open No. Hei 6-39018,
In the medical double-chamber container disclosed in Japanese Patent Application Laid-Open No. H11-169432, a detachable welding area is provided as an isolation means, but is sealed with a relatively weak strength by heat sealing. The peeling is performed with a relatively weak force. Further, since the sealing strength is largely controlled by the sheet thickness deviation, the resin blend ratio of the inner layer, the temperature control of the heat sealing, and the like, the value varies greatly, and the force required for peeling is slightly different for each container.
【０００５】さらに特開平１１−１６９４３２号の容器
は、対抗しあうプラスチックフィルム内面に易剥離性コ
ーティング材料を塗布してから剥離可能に接合される
が、この場合にフィルムの内面が開放状態となって、コ
ーティング工程で袋の内面に異物が混入することを避け
られない。また易剥離性コーティング材料は高圧蒸気殺
菌時に溶融しやす一方で、軟質容器では内圧が１．２ｋ
ｇ／ｃｍ２にまで達することから、剥離可能なシール領
域が滅菌工程中に連通されてしまうという不都合があ
り、製品の歩留率が低い。また搬送過程や保存時でおも
わぬ破袋が生ずるが散見されている。Further, the container disclosed in Japanese Patent Application Laid-Open No. 11-169432 is releasably joined by applying an easily releasable coating material to the inner surface of a plastic film which opposes. In this case, the inner surface of the film is opened. Therefore, it is unavoidable that foreign matter is mixed into the inner surface of the bag in the coating process. The easily peelable coating material is easily melted during high-pressure steam sterilization, while the internal pressure is 1.2 k in a soft container.
Since g / cm 2 is reached, the peelable seal area is in communication during the sterilization process, and the product yield is low. In addition, undesired breakage of the bag occurs during the transporting process and during the preservation, but it is scattered.
【０００６】[0006]
【発明が解決しようとする課題】本発明は上記問題点に
鑑み提案されたものであり、複室間の異種薬剤等を混合
して均一溶液にする医療用複室容器に於いて、複室間を
安定して隔離することができる医療用複室容器及びその
製造方法を提供することを目的とする。DISCLOSURE OF THE INVENTION The present invention has been proposed in view of the above problems, and is directed to a medical multi-chamber container for mixing a heterogeneous drug or the like between the multi-chambers into a uniform solution. It is an object of the present invention to provide a medical double-chamber container capable of stably isolating a container and a method of manufacturing the same.
【０００７】また他の目的は、複室間の異種薬剤等を混
合して均一溶液にする医療用複室容器に於いて、その製
造工程で複室間を隔離する部分が連通されることがな
く、製品の歩留率が高い医療用複室容器及びその製造方
法を提供することにある。It is another object of the present invention to provide a medical multi-chamber container in which a heterogeneous drug or the like between two or more chambers is mixed to form a uniform solution. Another object of the present invention is to provide a medical multi-chamber container having a high product yield and a method for producing the same.
【０００８】また他の目的は、複室間の異種薬剤等を混
合して均一溶液にする医療用複室容器に於いて、その製
造工程で容器内に異物が混入することがない医療用複室
容器及びその製造方法を提供することにある。Another object of the present invention is to provide a medical multi-chamber container which mixes different kinds of drugs and the like between the multi-chambers to form a uniform solution. An object of the present invention is to provide a chamber container and a method for manufacturing the same.
【０００９】[0009]
【課題を解決するための手段】本発明の医療用複室容器
は、薬剤等が収容される第一室と第二室を有し、該第一
室と該第二室は閉塞体を介して区画され、少なくとも一
部に薄肉縁部を介在して該閉塞体に連通部が設けられ、
該薄肉縁部の少なくとも一部を切断して該第一室と該第
二室を連通可能であることを特徴とする。The medical double-chamber container of the present invention has a first chamber and a second chamber for accommodating a medicine and the like, and the first chamber and the second chamber are connected via an obstruction. Communication part is provided in the closing body with a thin edge part interposed at least in part,
The first chamber and the second chamber can be communicated by cutting at least a part of the thin edge.
【００１０】さらに本発明の医療用複室容器は、上記医
療用複室容器に於いて、前記連通部の周縁の一部のみが
薄肉縁部であることを特徴とする。前記薄肉縁部を一部
のみとすることで、連通時に連通部が閉塞体に繋がった
状態にすることが可能となって、連通部が完全に分離さ
れて溶液中に浮遊するようなことがなくなる。[0010] Further, the medical multi-chamber container according to the present invention is characterized in that, in the medical multi-chamber container, only a part of the peripheral edge of the communicating portion is a thin-walled edge. By making the thin-walled edge part only, it becomes possible to make the communication part connected to the closing body at the time of communication, so that the communication part is completely separated and floats in the solution. Disappears.
【００１１】さらに本発明の医療用複室容器は、上記医
療用複室容器に於いて、可撓性プラスチックにより形成
され、多層構造を有することを特徴とする。Further, the medical multi-chamber container of the present invention is characterized in that the medical multi-chamber container is formed of a flexible plastic and has a multilayer structure.
【００１２】また本発明の医療用複室容器の製造方法
は、薬剤等が収容される第一室と第二室を有し、該第一
室と該第二室は閉塞体を介して区画され、少なくとも一
部に薄肉縁部を介在して該閉塞体に連通部が設けられ、
該薄肉縁部の少なくとも一部を切断して該第一室と該第
二室を連通可能である医療用複室容器の製造方法に於い
て、クロスヘッドダイを用いた押出の際に該閉塞体をプ
ラスチックフィルム内に連続して導入し、該プラスチッ
クフィルムの所定位置に連続して固着する工程を有する
ことを特徴とする。Further, the method for manufacturing a multi-chamber medical container according to the present invention has a first chamber and a second chamber for accommodating a medicine or the like, and the first chamber and the second chamber are partitioned via an obstruction. The communication portion is provided in the closing body with a thin edge portion interposed at least in part,
In a method for manufacturing a multi-chamber medical container in which at least a part of the thin-walled edge portion can be cut and the first chamber and the second chamber can be communicated with each other, in the extrusion using a crosshead die, the obstruction occurs. A step of continuously introducing the body into the plastic film and continuously fixing the body to a predetermined position of the plastic film.
【００１３】[0013]
【発明の実施の形態】以下、本発明を図に示す具体的な
実施形態に基づいて説明する。図１は本発明の医療用複
室容器の一実施形態を示す正面図、図２（ａ）は図１の
医療用複室容器に於ける閉塞体を示す縦断正面図、図２
（ｂ）はその連通状態を示す縦断正面図、図３は閉塞体
の変形例を示す一部縦断正面図である。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below with reference to specific embodiments shown in the drawings. FIG. 1 is a front view showing an embodiment of the medical multi-chamber container of the present invention, FIG. 2 (a) is a longitudinal sectional front view showing a closing body in the medical multi-chamber container of FIG.
(B) is a vertical front view showing the communication state, and FIG. 3 is a partial vertical front view showing a modification of the closing body.
【００１４】図１に於いて医療用複室容器１は、正面視
で略長方形状であって、全体として透明で可撓性を有す
るプラスチックフィルムからなり、その略中央に閉塞体
２が設けられていると共に、閉塞体２を所定位置に固着
しているシール領域３が容器内壁に形成され、前記閉塞
体２及びシール領域３を境界にして上方の第一室４と下
方の第二室５に区画されている。前記第一室４と第二室
５の所要箇所はそれぞれシールされており、その内部に
薬液などの薬剤等を収容し密封できるようになってい
る。In FIG. 1, a multi-chamber medical container 1 is substantially rectangular in a front view, is entirely made of a transparent and flexible plastic film, and has a closing body 2 provided substantially at the center thereof. In addition, a sealing area 3 for fixing the closing body 2 at a predetermined position is formed on the inner wall of the container, and the first chamber 4 and the second chamber 5 above and below the closing body 2 and the sealing area 3 are boundaries. Is divided into Necessary portions of the first chamber 4 and the second chamber 5 are respectively sealed, so that a medicine such as a chemical solution or the like can be accommodated therein and sealed.
【００１５】前記第一室４の略上端には、第一室４の内
部と外部を連通している充填口６が複室容器１の周縁部
によって把持されるように、その外周をプラスチックフ
ィルムによるヒートシールで固着されて設けられ、その
側方に複室容器１の吊下孔７が穿設されている。前記第
二室５の略下端には、第二室５の内部と外部を連通して
いる充填口８が設けられ、さらに別途第二室５の内部と
外部を連通する接続チューブ９と混注口１０が設けられ
ている。接続チューブ９は例えば腹膜へ通るカテーテル
の接続口等へ繋げるための軟質チューブであり、混注口
１０は注射器等により別途薬液等を注入する部分であ
る。前記充填口８、接続チューブ９、混注口１０も、複
室容器１の周縁部によって把持されるように、その外周
をプラスチックフィルムによるヒートシールで固着され
ている。前記充填口６、８は第一室４や第二室５に薬液
等を収容後にヒートシール等で塞がれる。また接続チュ
ーブ９は使用直前まで端シールされ、混注口１０には栓
で塞がれている。At the substantially upper end of the first chamber 4, the outer periphery of the first chamber 4 is formed of a plastic film so that the filling port 6 communicating the inside and the outside of the first chamber 4 is gripped by the periphery of the multi-chamber container 1. And a suspension hole 7 of the multi-chamber container 1 is formed on the side thereof. At a substantially lower end of the second chamber 5, a filling port 8 for communicating the inside and the outside of the second chamber 5 is provided, and a connection tube 9 for separately communicating the inside and the outside of the second chamber 5 and a mixed injection port. 10 are provided. The connection tube 9 is, for example, a soft tube for connecting to a connection port or the like of a catheter passing through the peritoneum, and the co-infusion port 10 is a portion into which a drug solution or the like is separately injected by a syringe or the like. The outer periphery of the filling port 8, the connection tube 9, and the co-injection port 10 is also fixed by heat sealing with a plastic film so as to be gripped by the peripheral portion of the multi-chamber container 1. The filling ports 6 and 8 are closed with a heat seal or the like after a chemical solution or the like is stored in the first chamber 4 or the second chamber 5. The end of the connection tube 9 is sealed until immediately before use, and the co-infusion port 10 is closed with a stopper.
【００１６】前記閉塞体２は、図２に示すように、略ド
ーナツ形の基部２１の中央に正面視で山形の連通部２２
が上方に凸設され、連通部２２の周縁は一部が略円周状
の薄肉縁部２３、前記薄肉縁部２３以外の周縁部分が厚
肉縁部２４で形成されており、連通部２２は薄肉縁部２
３及び厚肉縁部２４を介して基部２１に連設されてい
る。また閉塞体２は容器内壁にヒートシールすることに
より、シール領域３に強固に固着されている。As shown in FIG. 2, the closing body 2 has a communication portion 22 having a mountain shape in a front view at the center of a substantially donut-shaped base portion 21.
Is formed to project upward, and a part of the periphery of the communication part 22 is formed by a thin peripheral part 23 having a substantially circumferential shape, and a peripheral part other than the thin part 23 is formed by a thick part 24. Is thin edge 2
3 and the base 21 through the thick edge 24. Further, the closing body 2 is firmly fixed to the sealing area 3 by heat sealing to the inner wall of the container.
【００１７】前記閉塞体２は、連通部２２によって閉塞
された状態で形成されているが、連通部２２を摘みとし
て押すこと等により、薄肉縁部２３の部分を全て或いは
一部切断できるようになっており、前記切断によって図
２（ｂ）に示すように連通孔が形成され、第一室４と第
二室５を連通可能である。連通の際には、連通部２２は
完全に基部２１から分離せず、周縁の一部に設けられた
厚肉縁部２４を介して基部２１に繋がった状態となる。
従って、連通時に連通部２２は第一室４或いは第二室５
内に収容された薬液中に浮遊すること等がない。なお連
通部２２の周縁の全部を薄肉縁部２３にして形成するこ
とも可能である。The closing body 2 is formed so as to be closed by the communicating portion 22. The closing portion 2 can be cut completely or partially by pressing the communicating portion 22 with a knob or the like. The communication hole is formed as shown in FIG. 2B by the cutting, and the first chamber 4 and the second chamber 5 can be communicated. At the time of communication, the communication portion 22 is not completely separated from the base portion 21 and is connected to the base portion 21 through a thick edge portion 24 provided at a part of the periphery.
Therefore, at the time of communication, the communication part 22 is in the first chamber 4 or the second chamber 5.
It does not float in the chemical solution stored in the inside. In addition, it is also possible to form the whole periphery of the communication part 22 as the thin edge part 23.
【００１８】閉塞体２は上記形状のものに限定されず、
例えば図３に示すような形状であってもよい。図３に於
ける閉塞体２は、略ドーナツ形の基部２１の中央に正面
視で略Ｔ字形のプルトップ２２ａと球面部２２ｂとで形
成された連通部２２が上方に凸設され、連通部２２の周
縁は一部が略円周状の薄肉縁部２３、前記薄肉縁部２３
以外の周縁部分が厚肉縁部２４（図示せず）で形成され
ており、連通部２２は薄肉縁部２３及び厚肉縁部２４を
介して基部２１に連設されている。The closing body 2 is not limited to the above-mentioned shape.
For example, the shape may be as shown in FIG. In the closing body 2 in FIG. 3, a communication part 22 formed by a pull-up 22 a and a spherical part 22 b that are substantially T-shaped in a front view is provided at the center of a base part 21 having a substantially donut shape and project upward. The peripheral edge of the thin-walled edge portion 23 has a substantially circular shape.
The other peripheral portion is formed by a thick edge portion 24 (not shown), and the communication portion 22 is connected to the base portion 21 via the thin edge portion 23 and the thick edge portion 24.
【００１９】そして、上記医療用複室容器１を例えば腹
膜透析用液について使用する場合には、充填口６からｐ
Ｈ７．１の生理食塩液を１０００ｍｌ充填した後、充填
口６がヒートシールして塞がれる。次に充填口８から所
定濃度のぶどう糖液１０００ｍｌを充填した後、充填口
８がヒートシールして塞がれる。前記のように薬液が充
填された容器は高圧蒸気滅菌処理を施されことになる。When the medical multi-chamber container 1 is used for a peritoneal dialysis solution, for example,
After filling 1000 ml of H7.1 physiological saline solution, the filling port 6 is heat-sealed and closed. Next, after filling 1000 ml of glucose solution having a predetermined concentration from the filling port 8, the filling port 8 is closed by heat sealing. The container filled with the chemical solution as described above is subjected to high-pressure steam sterilization.
【００２０】上記医療用複室容器１は、異種の薬剤等を
確実に隔離して別々の室に保存することができるので、
高圧蒸気滅菌等により相互に反応して変質しやすい異種
の液体状の薬液を隔離保存すること等に好適である。In the medical double-chamber container 1, different kinds of drugs and the like can be reliably isolated and stored in separate chambers.
It is suitable for isolating and preserving different kinds of liquid chemicals which are susceptible to alteration due to mutual reaction by high-pressure steam sterilization or the like.
【００２１】なお医療用複室容器１の素材は適宜である
が、本発明の医療用複室容器は「医療用具および医療材
料の基礎的な生物学的試験のガイドライン１９９５解
説」（薬事日報社）でカテゴリー別医療用具例に分類さ
れている体内・体外連結器具に該当する。従って、ここ
に規定されている生物学的試験のガイドラインに合致す
る素材を用いることが好ましく、例えばポリエチレン、
ポリプロピレンあるいはこれらの共重合体およびポリマ
ーブレンド等を使用可能である。特に使用する可撓性プ
ラスチックフィルムとして、軟質ポリプロピレン系樹脂
を主体とするものを用いると好適である。The material of the medical multi-chamber container 1 is arbitrary, but the medical multi-chamber container of the present invention is described in "Guidelines for Basic Biological Testing of Medical Tools and Medical Materials 1995" (Yakuji Nippo Co., Ltd.). ) Corresponds to the internal / external connection device classified as a medical device example by category. Therefore, it is preferable to use a material that meets the biological test guidelines specified herein, for example, polyethylene,
Polypropylene or their copolymers and polymer blends can be used. In particular, it is preferable to use a film mainly composed of a soft polypropylene resin as the flexible plastic film to be used.
【００２２】また医療用複室容器１は単一の素材で形成
することも可能であるが、医療用容器として一層好まし
い耐熱性、易ヒートシール性、柔軟性を具備させるた
め、異なる機能の素材からなる多層フィルムで形成する
など、異なる機能を複合化した多層構造で形成すること
が好ましい。また上記複室容器１は第一室４と第二室５
の２つの複室容器の場合について説明したが、本発明は
２つ以上の隔絶された室を有する複室容器に適用可能で
ある。Although the medical multi-chamber container 1 can be formed of a single material, the medical multi-chamber container 1 is made of a material having different functions in order to provide heat resistance, heat sealability and flexibility which are more preferable as a medical container. It is preferable to form a multi-layer structure in which different functions are combined, such as a multi-layer film made of. The double chamber container 1 has a first chamber 4 and a second chamber 5.
However, the present invention is applicable to a multi-chamber container having two or more isolated chambers.
【００２３】次に、医療用複室容器１の製造工程例につ
いて説明する。図４は図１の医療用複室容器の製造工程
を示す概要図、図５はプラスチックフィルムと閉塞体が
圧着バーで固着される状態を示す一部断面平面図、図６
は圧着後のプラスチックフィルムと閉塞体を示す正面
図、図７は打抜加工後のプラスチックフィルムと閉塞体
を示す正面図、図８はシール加工後の医療用複室容器を
示す正面図である。Next, an example of a manufacturing process of the multi-chamber medical container 1 will be described. FIG. 4 is a schematic view showing a manufacturing process of the medical multi-chamber container of FIG. 1, FIG. 5 is a partial cross-sectional plan view showing a state in which a plastic film and a closing body are fixed by a pressure bar, and FIG.
Is a front view showing the plastic film and the closure after crimping, FIG. 7 is a front view showing the plastic film and the closure after punching, and FIG. 8 is a front view showing the medical multi-chamber container after sealing. .
【００２４】図４の製造ラインに於いて１１は押出成形
機であり、押出成形機１１の先端には略円筒状のクロス
ヘッドダイ１２が取り付けられている。クロスヘッドダ
イ１２の内側には閉塞体２のガイドレール１３が挿通し
て設けられており、又押出成形機１１の排出端からの溶
融材料の流路１２ａが形成され、前記流路１２ａは平面
視で略円筒状に形成されている。前記流路１２ａの排出
口は下向きに設けられ、クロスヘッドダイ１２から下方
に突出するガイドレール１３よりも外側に位置してい
る。さらにクロスヘッドダイ１２の下方には、順に水冷
リング１４、圧着バー１５、ピンチロール１６がそれぞ
れ所要間隔を開けて配設されている。前記圧着バー１５
の略中央は、図５に示すように、平面視で略半円形に形
成され、閉塞体２の外形に沿った形状になっている。In the production line of FIG. 4, reference numeral 11 denotes an extruder, and a substantially cylindrical crosshead die 12 is attached to the tip of the extruder 11. A guide rail 13 of the closing body 2 is inserted through the inside of the crosshead die 12, and a flow path 12a for molten material from the discharge end of the extruder 11 is formed. It is formed in a substantially cylindrical shape when viewed. The outlet of the flow channel 12a is provided downward, and is located outside the guide rail 13 projecting downward from the crosshead die 12. Further, below the crosshead die 12, a water-cooling ring 14, a pressure bonding bar 15, and a pinch roll 16 are disposed at required intervals. The crimping bar 15
5, is formed in a substantially semicircular shape in a plan view, as shown in FIG.
【００２５】上記製造ラインで医療用複室容器１を製造
するには、押出成形機１１から溶融樹脂１７ａをクロス
ヘッドダイ１２の流路１２ａに押し出し、流路１２ａの
下方の排出口から円筒状に溶融樹脂１７ａを排出する。
前記溶融樹脂１７ａは途中に設けられた水冷リング１４
を通過して冷却され、その外面が固化してフィルム１７
ｂの状態になる。前記プロセスに特に限定はなく、下向
きのインフレーション方式とすると良好であるが、実質
上フィルム１７ｂの外径はドローダウンで小さくなって
デフレーションフィルムになることから、クロスヘッド
ダイ１２の流路１２ａの口径はフィルム１７ｂの折径に
対してほぼ１．０近傍程度に設定すると好適である。In order to manufacture the multi-chamber medical container 1 on the above-mentioned production line, the molten resin 17a is extruded from the extruder 11 into the flow passage 12a of the crosshead die 12, and the cylindrical resin is discharged from the outlet below the flow passage 12a. The molten resin 17a is discharged.
The molten resin 17a is provided on the water cooling ring 14 provided on the way.
And the outer surface of the film 17 is solidified and cooled.
The state becomes b. The process is not particularly limited, and it is preferable to use a downward inflation method. However, since the outer diameter of the film 17b is substantially reduced by drawdown to become a deflation film, the flow path 12a of the crosshead die 12 is formed. It is preferable that the aperture is set to about 1.0 with respect to the folding diameter of the film 17b.
【００２６】前記フィルム成形と同時にガイドレール１
３で閉塞体２を案内し、フィルム１７の成形速度に対応
して一定の間隔でフィルム１７ｂ内に閉塞体２を導入し
ていく。閉塞体２がガイドレール１３から落下して圧着
バー１５・１５間に位置するタイミングで圧着バー１５
・１５が締まり、両側からフィルム１７ｂとその内側の
閉塞体２を締め付ける。この際、フィルム１７ｂの内面
は未だ導入された閉塞体２が仮溶着されるのに十分な熱
を持っているので、圧着バー１５・１５で圧力を加える
ことで閉塞体２はフィルム１７ｂの内面に固着される。
固着時に閉塞体２の周縁は完全にフィルム１７ｂの内面
に固着されることから、前記閉塞体２の上側と下側のフ
ィルム１７ｂは隔絶される。かような動作は連続して行
われ、図６に示すように、閉塞体２はフィルム１７ｂの
内面に所定間隔毎に固着されていく。The guide rail 1 is formed simultaneously with the film formation.
The closing body 2 is guided by 3 and the closing body 2 is introduced into the film 17b at a constant interval corresponding to the forming speed of the film 17. At the timing when the closing body 2 falls from the guide rail 13 and is positioned between the crimping bars 15, 15, the crimping bar 15
15 is tightened, and the film 17b and the closing body 2 inside the film 17b are tightened from both sides. At this time, since the inner surface of the film 17b has sufficient heat to temporarily weld the introduced closure 2, the closure 2 is pressed by the pressure bonding bars 15 To be fixed.
At the time of fixing, the peripheral edge of the closing body 2 is completely fixed to the inner surface of the film 17b, so that the upper and lower films 17b of the closing body 2 are isolated. Such an operation is performed continuously, and as shown in FIG. 6, the closing body 2 is fixed to the inner surface of the film 17b at predetermined intervals.
【００２７】前記閉塞体２の断面積の大きさは、インフ
レーション成形による場合には流路１２ａから排出され
る溶融樹脂１７ａの直径に対し略７０％以下とすると、
密閉系のフィルム内の圧力変動が小さくなって、折径を
安定することができ好適である。また、複室容器１の使
用時に第一室４と第二室５に保存された薬剤をすみやか
に混合するためには、閉塞体２の連通孔は充分大きくな
ければならないことから、前記連通孔の断面積の大きさ
は、流路１２ａから排出される溶融樹脂１７ａの直径に
対し少なくとも１０％以上は必要である。When the size of the cross-sectional area of the closing body 2 is about 70% or less of the diameter of the molten resin 17a discharged from the flow path 12a in the case of inflation molding,
This is preferable because the pressure fluctuation in the film of the closed system can be reduced and the folding diameter can be stabilized. Further, in order to promptly mix the medicines stored in the first chamber 4 and the second chamber 5 when the multi-chamber container 1 is used, the communication hole of the closing body 2 must be sufficiently large. Is required to be at least 10% or more of the diameter of the molten resin 17a discharged from the flow path 12a.
【００２８】その後、閉塞体２が圧着されたフィルム１
７ｂは、回転するピンチロール１６で折りたたまれると
同時に定速でひきとられる。前記ピンチロール１６は両
側方に移動可能で、フィルム１７ｂの閉塞体２の固着部
分を巻き取る際には両側方に応動するようになってい
る。Thereafter, the film 1 on which the closing body 2 is pressed
7b is folded at a constant speed while being folded by the rotating pinch roll 16. The pinch roll 16 is movable to both sides, and is adapted to respond to both sides when winding the portion of the film 17b to which the closing body 2 is fixed.
【００２９】上記製造方法で成形されたチューブ状のイ
ンフレーションフィルムは、内圧が外圧より陽圧に維持
されるのでほぼクローズドシステムで形成される。従っ
て、上記製造方法は外界から異物、雑菌が混入する機会
を極小に維持することが可能で、医療用容器の製造方法
として非常に好ましい。なお本発明の医療用複室容器１
は上記製造方法で製造されるものに限定されないが、ク
ロスヘッドダイ１２を用いた押出の際に閉塞体２をプラ
スチックフィルム１７ｂ内に連続して導入し、プラスチ
ックフィルム１７ｂの所定位置に連続して固着する工程
を用いて製造すると好適である。The tubular blown film formed by the above-described manufacturing method is formed in a substantially closed system since the internal pressure is maintained at a more positive pressure than the external pressure. Therefore, the above-mentioned manufacturing method can keep the chance of foreign substances and various germs mixed from the outside to be minimized, and is very preferable as a method for manufacturing a medical container. The medical multi-chamber container 1 of the present invention
Is not limited to the one manufactured by the above-described manufacturing method, but the plugging body 2 is continuously introduced into the plastic film 17b at the time of extrusion using the crosshead die 12, and continuously inserted into a predetermined position of the plastic film 17b. It is preferable to manufacture using a fixing step.
【００３０】なお腹膜透析は腹膜のもつ半透膜を利用
し、浸透圧差により血中の老廃物を体外に除去する原理
であり、透析の効率面からは高濃度のぶどう糖液を腹腔
内に充填したほうが好ましいが、腹膜の負荷を考えると
等張液とすべきである。このため、ぶどう糖液と生理食
塩液を事前に無菌的にかつ均一に混合して腹膜へ充填す
ることが考えられるが、その混合操作は煩雑であり、予
めぶどう糖液と生理食塩液の混合液を一つの容器に準備
しておく方が便利である。他方、ぶどう糖液は通常滅菌
による熱分解を防ぐためｐＨ５．５付近の弱酸性に維持
する必要があり、ｐＨ７．１付近の生理食塩液とは隔離
して滅菌されねばならない。かような場合に確実に区画
された第一室４と第二室５を使用直前に連通可能な複室
容器１は好適であり、混合操作が安全且つ容易で、滅菌
による薬液の分解を防止することができる。In addition, peritoneal dialysis is based on the principle of using a semi-permeable membrane of the peritoneum to remove waste products from the blood outside the body by means of a difference in osmotic pressure. It is preferable to use it, but in consideration of the load on the peritoneum, it should be made isotonic. For this reason, it is conceivable that the glucose solution and the physiological saline solution are mixed aseptically and uniformly beforehand and filled into the peritoneum, but the mixing operation is complicated, and the mixed solution of the glucose solution and the physiological saline solution is previously prepared. It is more convenient to prepare them in one container. On the other hand, glucose solutions usually need to be maintained at a weakly acidic pH of around 5.5 to prevent thermal decomposition due to sterilization, and must be sterilized separately from physiological saline at around pH 7.1. In such a case, the multi-chamber container 1 which can communicate the first chamber 4 and the second chamber 5 which are definitely partitioned immediately before use is preferable, the mixing operation is safe and easy, and the decomposition of the drug solution by sterilization is prevented. can do.
【００３１】[0031]
【発明の効果】本発明の医療用複室容器及びその製造方
法は上記構成であるから、複室間の異種薬剤等を混合し
て均一溶液にする医療用複室容器に於いて、複室間を安
定して隔離することができる効果を奏する。As described above, the medical multi-chamber container and the method for producing the same according to the present invention have the above-mentioned structure. This has the effect of stably separating the spaces.
【００３２】また本発明の医療用複室容器及びその製造
方法は、複室間の異種薬剤等を混合して均一溶液にする
医療用複室容器に於いて、その製造工程で複室間を隔離
する部分が連通されることがなく、その製品の歩留率を
向上することができる効果を奏する。Further, the medical multi-chamber container and the method of manufacturing the same according to the present invention provide a medical multi-chamber container in which different kinds of medicines and the like between the multi-chambers are mixed to form a uniform solution. There is an effect that the isolated portion is not communicated, and the yield of the product can be improved.
【００３３】また本発明の医療用複室容器及びその製造
方法は、複室間の異種薬剤等を混合して均一溶液にする
医療用複室容器に於いて、その製造工程で容器内に異物
が混入することがない効果を奏する。Further, according to the medical multi-chamber container and the method for producing the same of the present invention, in a medical multi-chamber container which mixes different kinds of medicines and the like between the multi-chambers to form a uniform solution, foreign matter is contained in the container in the manufacturing process. This has the effect of not mixing.
【図１】本発明の医療用複室容器の一実施形態を示す正
面図。FIG. 1 is a front view showing an embodiment of a medical double-chamber container of the present invention.
【図２】（ａ）図１の医療用複室容器に於ける閉塞体を
示す縦断正面図。 （ｂ）同図（ａ）の閉塞体の連通状態を示す縦断正面
図。FIG. 2 (a) is a longitudinal sectional front view showing a closing body in the multi-chamber medical container of FIG. (B) A longitudinal sectional front view showing a communicating state of the closing body in FIG.
【図３】閉塞体の変形例を示す一部縦断正面図。FIG. 3 is a partially longitudinal front view showing a modification of the closing body.
【図４】図１の医療用複室容器の製造工程を示す概要
図。FIG. 4 is a schematic view showing a manufacturing process of the medical double-chamber container of FIG. 1;
【図５】プラスチックフィルムと閉塞体が圧着バーで固
着される状態を示す一部断面平面図。FIG. 5 is a partial cross-sectional plan view showing a state in which the plastic film and the closing member are fixed by a pressure bar.
【図６】圧着後のプラスチックフィルムと閉塞体を示す
正面図。FIG. 6 is a front view showing the plastic film and the closure after pressure bonding.
【図７】打抜加工後のプラスチックフィルムと閉塞体を
示す正面図。FIG. 7 is a front view showing the plastic film and the closing body after punching.
【図８】シール加工後の医療用複室容器を示す正面図。FIG. 8 is a front view showing the medical multi-chamber container after sealing.
１ 医療用複室容器 ２ 閉塞体 ２１ 基部 ２２ 連通部 ２２ａ プルトップ ２２ｂ 球面部 ２３ 薄肉縁部 ２４ 厚肉縁部 ３ シール領域 ４ 第一室 ５ 第二室 ６、８ 充填口 １１ 押出成形機 １２ クロスヘッドダイ １２ａ 流路 １５ 圧着バー １７ａ 溶融樹脂 １７ｂ フィルム DESCRIPTION OF SYMBOLS 1 Medical double-chamber container 2 Closed body 21 Base 22 Communication part 22a Pull-top 22b Spherical part 23 Thin edge part 24 Thick edge part 3 Seal area 4 First chamber 5 Second chamber 6, 8 Filling port 11 Extruder 12 Cross Head die 12a Channel 15 Crimping bar 17a Molten resin 17b Film
Claims (4)
し、該第一室と該第二室は閉塞体を介して区画され、少
なくとも一部に薄肉縁部を介在して該閉塞体に連通部が
設けられ、該薄肉縁部の少なくとも一部を切断して該第
一室と該第二室を連通可能である医療用複室容器。1. A first chamber and a second chamber for accommodating a medicine and the like, wherein the first chamber and the second chamber are partitioned via an obstructing body, and at least a part thereof is provided with a thin-walled edge portion. A medical multi-chamber container, wherein a communication portion is provided in the closing body, and at least a part of the thin-walled edge portion is cut to allow communication between the first chamber and the second chamber.
であることを特徴とする請求項１記載の医療用複室容
器。2. The medical double-chamber container according to claim 1, wherein only a part of a peripheral edge of the communication portion is a thin-walled edge portion.
層構造を有することを特徴とする請求項１又は２記載の
医療用複室容器。3. The multi-chamber medical container according to claim 1, wherein the multi-chamber medical container is formed of a flexible plastic and has a multilayer structure.
し、該第一室と該第二室は閉塞体を介して区画され、少
なくとも一部に薄肉縁部を介在して該閉塞体に連通部が
設けられ、該薄肉縁部の少なくとも一部を切断して該第
一室と該第二室を連通可能である医療用複室容器の製造
方法に於いて、 クロスヘッドダイを用いた押出の際に該閉塞体をプラス
チックフィルム内に連続して導入し、該プラスチックフ
ィルムの所定位置に連続して固着する工程を有すること
を特徴とする医療用複室容器の製造方法。4. It has a first chamber and a second chamber for accommodating a medicine and the like, the first chamber and the second chamber are partitioned via a closing body, and at least a part thereof has a thin-walled edge. A communication part is provided in the closing body, and at least a part of the thin edge is cut so that the first chamber and the second chamber can communicate with each other. Manufacturing a multi-chamber medical container, comprising a step of continuously introducing the closed body into a plastic film at the time of extrusion using a head die and continuously fixing the closed body at a predetermined position of the plastic film. Method.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2000134561A JP2001314484A (en) | 2000-05-08 | 2000-05-08 | Medical plural chamber container and manufacturing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2000134561A JP2001314484A (en) | 2000-05-08 | 2000-05-08 | Medical plural chamber container and manufacturing method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2001314484A true JP2001314484A (en) | 2001-11-13 |
Family
ID=18642818
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2000134561A Withdrawn JP2001314484A (en) | 2000-05-08 | 2000-05-08 | Medical plural chamber container and manufacturing method thereof |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2001314484A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100340454C (en) * | 2005-05-13 | 2007-10-03 | 湖南千山制药机械股份有限公司 | Method for pouring liquid and solid in anti-adhersive multi-chamber perfusion bag made of non-PCV film |
| CN100368263C (en) * | 2006-03-03 | 2008-02-13 | 湖南千山制药机械股份有限公司 | Production of multiple chamber-bags for large infusion for preventing from opening pollution at charging after sterilization |
-
2000
- 2000-05-08 JP JP2000134561A patent/JP2001314484A/en not_active Withdrawn
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100340454C (en) * | 2005-05-13 | 2007-10-03 | 湖南千山制药机械股份有限公司 | Method for pouring liquid and solid in anti-adhersive multi-chamber perfusion bag made of non-PCV film |
| CN100368263C (en) * | 2006-03-03 | 2008-02-13 | 湖南千山制药机械股份有限公司 | Production of multiple chamber-bags for large infusion for preventing from opening pollution at charging after sterilization |
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