JP2005137426A - Multi-chamber transfusion container and multi-chamber transfusion container containing medicament - Google Patents

Multi-chamber transfusion container and multi-chamber transfusion container containing medicament Download PDF

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JP2005137426A
JP2005137426A JP2003374368A JP2003374368A JP2005137426A JP 2005137426 A JP2005137426 A JP 2005137426A JP 2003374368 A JP2003374368 A JP 2003374368A JP 2003374368 A JP2003374368 A JP 2003374368A JP 2005137426 A JP2005137426 A JP 2005137426A
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container
chamber
seal portion
partition member
partition
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JP4476598B2 (en
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Yohei Kageyama
陽平 蔭山
Manabu Nakamura
学 中村
Akihiko Sakata
明彦 坂田
Katsuyuki Yoshikawa
克行 吉川
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Showa Denko Plastic Products Co Ltd
Ajinomoto Pharmaceuticals Co Ltd
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Ajinomoto Pharma Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a multi-chamber transfusion container with a plurality of small chambers, practically capable of productive, easy and speedy mixing. <P>SOLUTION: The multi-chamber transfusion container consists of a first container and a second container with chambers to store medicament. The first and second containers are made of flexible materials and are integrated and divided by a partition member. The partition member comprises a cylinder member for connecting two adjacent containers to communicate with each other, a partition body for dividing the adjacent containers liquid-tightly, and a fracturable thin part in the connection part of the partition body and the cylinder member. The first container has at least two large chambers divided by a partition means to communicate, and the second container has at least two small chambers divided by a separable weak sealing part. The small chambers of the second container include a first small chamber adjacent to the partition member and a second small chamber adjacent to the first small chamber via the weak sealing part. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、複室輸液容器及び薬剤入り複室輸液容器に関する。   The present invention relates to a multi-chamber infusion container and a multi-chamber infusion container containing a medicine.

従来から、薬剤や栄養剤を収容保存するため、樹脂製容器やガラス容器が利用されている。
注射剤、静脈投与用輸液、透析溶液、点眼剤、眼科用灌流液及び臓器保存液等の輸液溶液は、容器にほぼ液密に充填され、殺菌又は滅菌される。
これらの製品形態のひとつにキット製品があり、上市されている。キット製品は、薬剤と医療用具又は2つ以上の薬剤をひとつの投与体系として組合せたものである。
キット製品の事例は、予充填式使い捨て注射剤(プレフィルドシリンジ製品)、ダブルバッグと呼ばれる2室混合式輸液剤、例えば味の素ファルマ社製の「ピーエヌツイン」(商品名)等である。
キット製品は、医療機関における投薬調剤時の負担軽減、細菌汚染防止、異物混入防止、調剤時の過誤防止、緊急時の迅速な対応を可能にするなどの利点を備えている。
Conventionally, resin containers and glass containers have been used to store and store medicines and nutrients.
Infusion solutions such as injections, infusions for intravenous administration, dialysis solutions, eye drops, ophthalmic perfusates, and organ preservation solutions are filled almost liquid-tightly and sterilized or sterilized.
One of these product forms is a kit product, which is marketed. A kit product is a combination of a drug and a medical device or two or more drugs as a single administration system.
Examples of kit products are prefilled disposable injections (prefilled syringe products), two-chamber mixed-type infusions called double bags, such as “PN Twin” (trade name) manufactured by Ajinomoto Pharma.
The kit product has advantages such as reduction of burden during dispensing in a medical institution, prevention of bacterial contamination, prevention of contamination, prevention of errors during dispensing, and quick response in an emergency.

キット製品は、容器を2室または3室に区画したものが上市されているが、投与する患者の病態に応じ、小容量の抗生物質やビタミン類などの追加の薬剤や栄養剤等を加えるために、使用時に容器内に注入して混合する混注作業が行われる場合も多い。
例えば、高カロリー輸液療法では、体内代謝を正常に維持するために必要なアミノ酸、糖質、電解質が収容されたダブルバッグに、患者への投与直前に、ビタミン類などの微量栄養素を混注して患者に非経口的に投与することが行われている。この投与直前の混注は、ビタミン類などの薬剤を予めダブルバッグの中に添加しておくことが、製剤としての安定性が必ずしも十分で無いことがあるためである。
混注作業が行われると従前のキット製品が備える利点のかなりの部分が失われてしまう。
また、複数種の薬剤の混注作業を繰り返し行う場合もある。
Kit products are available in two or three compartments. To add additional drugs or nutrients such as small-volume antibiotics or vitamins, depending on the patient's condition. In addition, there is often a mixed injection operation in which the mixture is injected into the container and mixed at the time of use.
For example, in high-calorie infusion therapy, micronutrients such as vitamins are mixed in a double bag containing amino acids, carbohydrates, and electrolytes necessary to maintain normal metabolism in the body just before administration to patients. It has been administered parenterally to patients. This mixed injection immediately before administration is because it is not always sufficient as a preparation to add a drug such as vitamins in a double bag in advance.
When mixed injection work is performed, a considerable part of the advantages of previous kit products is lost.
In some cases, the co-infusion operation of a plurality of types of medicines is repeated.

そこで、混注作業を行わずとも輸液を安全に行うために、3室以上の薬剤室を備えた輸液容器が提案されている。
例えば、複数の薬剤室を区画する隔壁に設けられた使用時に比較的硬質の樹脂からなる破断可能な流路閉塞体や壁構成からなる連通可能部を有する輸液用容器が提案されている(例えば、特許文献1参照。)。
また、複数の収容室を有し、周囲が密封された合成樹脂製複室容器であって、少なくとも一部の複数の前記収容室を、剥離不能な強シール部と、接続部において強シール部と接続する剥離可能な弱シール部とで液密に区画した複室容器が提案されている(例えば、特許文献2参照。)。この複室容器は剥離不能な強シール部と剥離可能な弱シール部の場所を特定の位置に多数配置している。
Therefore, an infusion container having three or more drug rooms has been proposed in order to perform infusion safely without performing mixed injection work.
For example, an infusion container having a breakable flow path blocker made of a relatively hard resin and a communicable portion made of a wall structure provided in a partition partitioning a plurality of drug chambers has been proposed (for example, , See Patent Document 1).
Also, a synthetic resin multi-chamber container having a plurality of storage chambers, the periphery of which is sealed, wherein at least some of the plurality of storage chambers are separated from a strong seal portion that cannot be peeled off, and a strong seal portion at a connection portion There has been proposed a multi-chamber container that is liquid-tightly divided by a peelable weak seal portion that is connected to (see, for example, Patent Document 2). In this multi-chamber container, a large number of locations of strong seal portions that cannot be peeled off and weak seal portions that can be peeled are arranged at specific positions.

また、2室からなる従来のダブルバッグの形状をほぼ維持しつつ、可撓性容器からなる3番目の室を設けた例として、薬液収容室内に易剥離性シール部を備える薬液収容小袋を吊設し、薬液収容小袋を薬液収容室を区画する両壁面に強シールした薬液収容小袋付き薬液容器が提案されている(例えば、特許文献3参照。)。小袋部は使用直前に容易に破袋させやすいものになっている。
また、2室からなる従来のダブルバッグの形状をほぼ維持しつつ硬質容器からなる3番目の室を設けた例として、A室とB室の間に連通可能な隔離壁を有し、A室またはB室に輸液供給部が設けられており、輸液供給部内にC室が含有され、C室は破断によりA室またはB室へ連通する連通用部材を有する3室の輸液容器の提案がある(例えば、特許文献4参照。)。
In addition, as an example in which a third chamber made of a flexible container is provided while substantially maintaining the shape of a conventional double bag made up of two chambers, a chemical solution containing pouch equipped with an easily peelable seal portion is suspended in the chemical solution containing chamber. A chemical solution container with a chemical solution storage pouch has been proposed in which a chemical solution storage pouch is strongly sealed on both wall surfaces that define the chemical solution storage chamber (see, for example, Patent Document 3). The pouch portion is easy to break the bag immediately before use.
In addition, as an example in which a third chamber made of a rigid container is provided while substantially maintaining the shape of a conventional double bag consisting of two chambers, a separation wall that can communicate between the A chamber and the B chamber is provided. Alternatively, the infusion supply section is provided in the B chamber, the C chamber is contained in the infusion supply section, and there is a proposal of a three-chamber infusion container having a communication member that communicates with the A chamber or the B chamber by breaking. (For example, refer to Patent Document 4).

また、不測の力で剥離する可能性が極めて低く抑えられ、連通断面積が広く、迅速な混合が可能なものとして、弱シール部の代わりに仕切部に硬質な樹脂を用いた、連通断面積が広い複室容器が提案されている。例えば、隣接する2つの容器を連通可能に接続する中空部と、この中空部の少なくとも一端を封止する蓋体とが形成され、前記蓋体と前記仕切部材の本体との連結部には、薄肉部が形成されている仕切部材を用いた複室輸液容器が提案されている(例えば、特許文献5参照。)。ここには2種の薬剤を2室に収容した容器が開示されている。
特開2000−5275号公報(第7頁、第10図) 特開2002−160771号公報 特開2003−62038号公報 特開2000−273035号公報 特開2001−87350号公報
In addition, the possibility of delamination due to unforeseen force is extremely low, the communication cross-sectional area is wide, and it is possible to mix quickly. A large multi-chamber container has been proposed. For example, a hollow part that connects two adjacent containers so as to communicate with each other, and a lid that seals at least one end of the hollow part are formed, and a connection part between the lid and the main body of the partition member includes: A multi-chamber infusion container using a partition member in which a thin portion is formed has been proposed (see, for example, Patent Document 5). Here, a container containing two kinds of medicines in two chambers is disclosed.
JP 2000-5275 (page 7, FIG. 10) JP 2002-160771 A JP 2003-62038 A JP 2000-273035 A JP 2001-87350 A

特許文献1記載の輸液容器においては、流路閉塞体や破壊しやすい壁構成を破断することで薬剤室の連通口を開口させ、薬剤が混合することが可能となるが、連通口の断面積が小さく、緊急時の迅速な対応に支障をきたすおそれがある。   In the infusion container described in Patent Document 1, it is possible to open the communication port of the drug chamber by breaking the channel blockage body and the easily breakable wall structure, and the drug can be mixed. , And there is a risk of impeding rapid response in an emergency.

特許文献2記載の複室容器は、剥離不能な強シール部と剥離可能な弱シール部の場所を特定の位置に多数配置している。従って、複雑な形状の全ての弱シール部を、目的とする開通強度で剥離できる複室容器にするためには、弱シール部を設計通りに精密に作成する必要があり、このような複室容器を安定的に製造するための精密な製造装置及び製造条件の設定が要求される。また、複室輸液容器本体はシール部により内面同士が接着されているため、容量が大きく厚みの厚い大室と、容量が小さく厚みの薄い小室とが組み合わさった容器全体は、輸液等を充填した後は細かな凹凸が生じ、輸送時や保管時に凸部が押圧されると弱シール部が剥離するおそれがあり、慎重な取扱が要求される。
また、連通開口部より長く形成された剥離可能な弱シール部に、移送や保管時に応力が外部から作用した時に応力が集中する角部を有し、剥離しやすいものとなっている。
また、小室と大室とが剥離可能な弱シール部からなる連通開口部により、液密に閉じられているため、不測の際に大室が受ける圧力に耐えられるだけの剥離強度が前記連通開口部には要求される。
In the multi-chamber container described in Patent Document 2, a large number of places of strong seal portions that cannot be peeled off and weak seal portions that can be peeled are arranged at specific positions. Therefore, in order to make all the weak seals of complicated shape into a multi-chamber container that can be peeled off with the desired opening strength, it is necessary to make the weak seals precisely as designed. Precise manufacturing equipment and manufacturing conditions are required to stably manufacture the container. In addition, since the inner surface of the multi-chamber infusion container body is bonded to each other by a seal portion, the entire container that combines a large chamber with a large capacity and a large thickness and a small chamber with a small capacity and a small thickness is filled with infusion fluid, etc. After that, fine irregularities occur, and if the convex part is pressed during transportation or storage, the weak seal part may be peeled off, and careful handling is required.
Further, the peelable weak seal portion formed longer than the communication opening has a corner portion where stress concentrates when stress is applied from the outside during transfer or storage, and is easily peeled off.
In addition, since the small chamber and the large chamber are liquid-tightly closed by a communication opening made of a weak seal portion that can be peeled off, the communication opening has a peel strength sufficient to withstand the pressure received by the large chamber in the event of an unexpected event. Required by the department.

また、特許文献3記載の容器は、その小袋部で外容器の容器内面が拘束されているため、容器形状に凹凸が生じることや、小袋部に応力が集中し易く、輸送や保管時の子袋の破袋防止も考慮した複雑な容器設計が要求される。
特許文献4記載の輸液容器は、小容量のC室と同様の構成を用いて、さらに多室にしようとすると、その数だけC室が必要となり構造が複雑になるのと同時に、室数が増えれば増えるほど、全ての薬剤を混合するための操作回数が増えることになる。
Moreover, since the container inner surface of the outer container is restrained by the sachet portion of the container described in Patent Document 3, irregularities are generated in the container shape, and stress tends to concentrate on the sachet portion. Complicated container design that takes into account the prevention of bag breakage is required.
The infusion container described in Patent Document 4 uses the same configuration as that of the small-capacity C chamber, and if the number of chambers is further increased, the number of chambers becomes complicated. As the number increases, the number of operations for mixing all the drugs increases.

上記特許文献1〜4の複室輸液容器においては、輸液の投与直前に連通する液密な仕切部として剥離可能な弱シール部が用いられている。
この弱シール部は剥離後の連通断面積が広く、迅速な混合が可能であるため好ましいが、製造工程における内容物の充填圧、滅菌時の高温で発生する内圧、輸送及び保管時の外圧など不測の力で剥離してしまうことがある。
弱シール部を用いて多室化しようとすると、この様な不測の力による剥離の可能性が更に高くなってくる。
In the multi-chamber infusion containers of Patent Documents 1 to 4, a peelable weak seal portion is used as a liquid-tight partition that communicates immediately before administration of the infusion solution.
This weak seal part is preferable because it has a wide communication cross-sectional area after peeling and can be quickly mixed, but the filling pressure of the contents in the manufacturing process, the internal pressure generated at a high temperature during sterilization, the external pressure during transportation and storage, etc. It may peel off by unexpected force.
When the number of chambers is increased by using the weak seal portion, the possibility of peeling due to such an unexpected force is further increased.

特許文献5には、薬剤入りの3室以上の複室容器については全く記載が無い。
これらのことから、小室を複数有する複室輸液容器であって、生産性、開通性、迅速な混合が実用的に可能な複室輸液容器が望まれていた。
本発明は、かかる状況に鑑みてなされたものであり、上記課題を改善した複室輸液容器を提供することを課題とする。
Patent Document 5 has no description of a multi-chamber container containing three or more chambers containing medicines.
For these reasons, there has been a demand for a multi-chamber infusion container having a plurality of small chambers, which is practically capable of productivity, patency, and quick mixing.
This invention is made | formed in view of this situation, and makes it a subject to provide the multi-chamber infusion container which improved the said subject.

本発明者らは、使用直前まで薬剤の誤混合を起こすことなく、使用時には簡単な操作で迅速に無菌混合が可能であり、取扱い及び多室化が容易な複室輸液容器について鋭意研究を重ねた結果、大室を有する第1容器と小室の集合体である第2容器を分離し特定の連通可能な仕切部材により一体化した複室輸液容器により、上記課題が解決できることを見出し、本発明を完成するに至ったものである。   The present inventors have conducted extensive research on a multi-chamber infusion container that can be rapidly mixed aseptically by a simple operation at the time of use without causing erroneous mixing of the drug until immediately before use, and easy to handle and multi-chamber. As a result, it has been found that the above problems can be solved by a multi-chamber infusion container in which a first container having a large chamber and a second container which is an assembly of small chambers are separated and integrated by a specific communicating partition member. Has been completed.

即ち、本発明は、以下に記載の複室輸液容器に関する。
1)薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器は剥離可能な弱シール部で区画された2つ以上の小室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室とを具備してなり、第1容器を下側、第2容器を上側に配置したとき、前記第2容器内の弱シール部の少なくとも一つは前記第2容器の下端の強シール部と前記第2容器の上端または側部の強シール部との間を仕切ってなるものであることを特徴とする複室輸液容器。
That is, the present invention relates to the multi-chamber infusion container described below.
1) In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member and first A multi-chamber infusion container partitioned between the container and the second container,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a partition means capable of communication, and the second container has two or more small chambers partitioned by a peelable weak seal portion, The chamber of the second container includes a first chamber adjacent to the partition member and a second chamber adjacent to the first chamber via the weak seal portion, and the first container is placed under the first container. When the second container is disposed on the side, at least one of the weak seal portions in the second container is a strong seal portion at the lower end of the second container and a strong seal portion at the upper end or the side portion of the second container. A multi-chamber infusion container characterized by being partitioned between the two.

2)薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器は剥離可能な弱シール部で区画された2つ以上の小室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室とを具備してなり、第1容器を下側、第2容器を上側に配置したとき、前記弱シール部は前記第2容器の両側部を結ぶ様に形成され、前記弱シール部と第2容器上端の強シール部の間に形成された複数の第2の小室間が、前記上端の強シール部の一部から延びる第2の強シール部で仕切られているものであることを特徴とする複室輸液容器。
2) In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member and the first container A multi-chamber infusion container partitioned between the container and the second container,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a partition means capable of communication, and the second container has two or more small chambers partitioned by a peelable weak seal portion, The chamber of the second container includes a first chamber adjacent to the partition member and a second chamber adjacent to the first chamber via the weak seal portion, and the first container is placed under the first container. When the second container is disposed on the side, the weak seal portion is formed so as to connect both side portions of the second container, and is formed between the weak seal portion and the strong seal portion at the upper end of the second container. A multi-chamber infusion container characterized in that a plurality of second small chambers are partitioned by a second strong seal portion extending from a part of the strong seal portion at the upper end.

3)薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器は剥離可能な弱シール部で区画された2つ以上の小室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室と、前記弱シール部を介して前記第2の小室に隣接する第3の小室とを具備してなることを特徴とする複室輸液容器。
3) In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member and the first container A multi-chamber infusion container partitioned between the container and the second container,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a partition means capable of communication, and the second container has two or more small chambers partitioned by a peelable weak seal portion, The second container chamber includes a first chamber adjacent to the partition member, a second chamber adjacent to the first chamber via the weak seal portion, and the second chamber via the weak seal portion. A multi-chamber infusion container comprising a third chamber adjacent to the other chamber.

4)第1容器を下側、第2容器を上側に配置したとき、仕切部材を挟んで設けられた第2容器下端の2つの強シール部の仕切部材に面する両端を結ぶように弱シール部が設けられ、該弱シール部と2つの下端強シール部、仕切部材とで囲まれた第1の小室が形成され、両側の下端強シール部のそれぞれから前記第2容器の上端強シール部を結ぶように弱シール部が設けられ、これらの弱シール部と前記上端強シール部に囲まれて第2の小室が形成されてなるものであることを特徴とする前記3)記載の複室輸液容器。 4) When the first container is disposed on the lower side and the second container is disposed on the upper side, a weak seal is formed so as to tie both ends facing the partition members of the two strong seal portions at the lower end of the second container provided across the partition member. A first small chamber surrounded by the weak seal portion, the two lower end strong seal portions, and the partition member, and the upper end strong seal portion of the second container from each of the lower end strong seal portions on both sides. The multiple chamber according to 3), wherein a weak seal portion is provided so as to connect the two, and a second small chamber is formed by being surrounded by the weak seal portion and the upper end strong seal portion. Infusion container.

5)第1容器を下側、第2容器を上側に配置したとき、前記第2容器の両側部を結ぶ様に2本の弱シール部が設けられ、その弱シール部の少なくとも一つが、その一部に角部を有する屈曲部を有することを特徴とする前記3)記載の複室輸液容器。 5) When the first container is disposed on the lower side and the second container is disposed on the upper side, two weak seal portions are provided so as to connect both side portions of the second container, and at least one of the weak seal portions is 3. The multi-chamber infusion container according to 3) above, which has a bent part having a corner part.

6)薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室とを具備してなり、第1容器を下側、第2容器を上側に配置したとき、前記第2容器は仕切部材と、該仕切部材の両側部から水平に延びる強シール部から構成される下端と該下端の両端から伸びる上に凸の弧状強シール部により外周が形成され、前記第2容器内の弱シール部は前記第2容器の下端の強シール部と弧状強シール部との間を仕切ってなるものであることを特徴とする複室輸液容器。
6) In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member and the first container A multi-chamber infusion container partitioned between the container and the second container,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a communicating partition means, and the small chamber of the second container includes a first small chamber adjacent to the partition member and the weak seal portion. A second chamber adjacent to the first chamber, and when the first container is disposed on the lower side and the second container is disposed on the upper side, the second container has a partition member and the partition member. The outer periphery is formed by a lower end composed of a strong seal portion extending horizontally from both sides of the upper end and an arc-shaped strong seal portion extending from both ends of the lower end, and the weak seal portion in the second container is the second container. A multi-chamber infusion container characterized in that it is formed by partitioning a strong seal portion at the lower end of an arc and a strong arc-shaped seal portion.

7)第1容器及び第2容器が仕切部材並びに強シール部により一体化され、該強シール部の少なくとも一方に複室輸液容器の表から裏へ指を挿入できる開口部を設けてなることを特徴とする前記1)〜6)のいずれか1項に記載の複室輸液容器。 7) The first container and the second container are integrated by a partition member and a strong seal portion, and at least one of the strong seal portions is provided with an opening for inserting a finger from the front to the back of the multi-chamber infusion container. The multi-chamber infusion container according to any one of 1) to 6), which is characterized in that

8)前記薄肉部を破断させた後に、第1容器を一回押圧するだけで、第1容器及び第2容器内の全ての室が連通可能であることを特徴とする前記1)〜7)のいずれか1項に記載の複室輸液容器。 8) All the chambers in the first container and the second container can communicate with each other only by pressing the first container once after the thin-walled portion is broken. The multi-chamber infusion container according to any one of the above.

9)第2容器の室の少なくとも1室が遮光部材で遮光されていることを特徴とする前記1)〜8)のいずれか1項に記載の複室輸液容器。 9) The multi-chamber infusion container according to any one of 1) to 8) above, wherein at least one of the chambers of the second container is shielded from light by a light shielding member.

10)第2容器の最内層が脂溶性ビタミンに対して低吸着性の材料からなることを特徴とする前記1)〜9)のいずれか1項に記載の複室輸液容器。 10) The multi-chamber infusion container according to any one of 1) to 9) above, wherein the innermost layer of the second container is made of a material having low adsorptivity to the fat-soluble vitamin.

11)第2容器の全ての弱シール部が仕切部材に隣接する第1の小室の周縁の弱シール部であることを特徴とする前記1)〜10)のいずれか1項に記載の複室輸液容器。 11) The multiple chambers according to any one of 1) to 10) above, wherein all weak seal portions of the second container are weak seal portions at the periphery of the first small chamber adjacent to the partition member. Infusion container.

12)第2容器の少なくとも1つの室が注入口を有する予備室であることを特徴とする前記1)〜11)のいずれか1項に記載の複室輸液容器。 12) The multi-chamber infusion container according to any one of 1) to 11) above, wherein at least one chamber of the second container is a preliminary chamber having an injection port.

13)前記1)〜12)のいずれか1項に記載の複室輸液容器における、第1容器の室に糖、電解質及びアミノ酸のいずれか1種以上を含有する薬剤が収容され、第2容器の室に水溶性ビタミン、脂溶性ビタミン及び微量元素のいずれか1種以上を含有する薬剤が収容されることを特徴とする薬剤入り複室輸液容器。 13) In the multi-chamber infusion container according to any one of 1) to 12) above, a medicine containing any one or more of sugar, electrolyte, and amino acid is accommodated in the chamber of the first container, and the second container A drug-containing multi-chamber infusion container characterized in that a medicine containing any one or more of water-soluble vitamins, fat-soluble vitamins and trace elements is contained in the chamber.

本発明の複室輸液容器は、可撓性材料からなる第1容器及び第2容器が連通可能な仕切部材により一体化され、各容器中の各室に薬剤が収容されていることにより、投与を行うまでは各薬剤の漏洩、混合のおそれがなく、投与直前に各薬剤を容易に迅速に混合することができる。   In the multi-chamber infusion container of the present invention, the first container and the second container made of a flexible material are integrated by a partition member that can communicate, and the medicine is accommodated in each chamber in each container. Until this is done, there is no risk of leakage or mixing of each drug, and each drug can be easily and quickly mixed immediately before administration.

本発明の複室輸液容器は、第1容器の大室と、第2容器の小室が仕切部材により分離され、偶発的な力により大室と小室間が連通することなく、投与を行うまでは各薬剤の漏洩、混合のおそれがない。
本発明の複室輸液容器は、第1容器の大室と第2容器の小室が仕切部材により分離され、小室が大室にかかる力の影響をうけることがなく、剥離可能な弱シール部による第2容器の多室化が容易である。
In the multi-chamber infusion container of the present invention, the large chamber of the first container and the small chamber of the second container are separated by a partition member, and until administration is performed without communication between the large chamber and the small chamber due to accidental force. There is no risk of leakage or mixing of each drug.
In the multi-chamber infusion container of the present invention, the large chamber of the first container and the small chamber of the second container are separated by a partition member, and the small chamber is not affected by the force applied to the large chamber, and is provided with a peelable weak seal portion. Multiple chambers of the second container are easy.

以下、本発明を詳細に説明する。
本発明において、図1に示すように第2容器2側を上、第1容器1側が下になるように上下左右を定義し、左右方向の長さを幅、上下の長さを高さとして説明する。側部は上下に延びる左右端の部分である。
また、弱シール部とは、複室輸液容器の洗浄、分注、滅菌時に簡単に剥離せず、使用時には容器を構成する可撓性材料を介して室に充填した薬剤に人手で圧力を加えることにより、容器本体を破損させること無く、シール部が容易に剥離可能で複数の室間を連通させ得るシール部である。強シール部は通常の使用においては剥離不可能なシール部である。
Hereinafter, the present invention will be described in detail.
In the present invention, as shown in FIG. 1, the top, bottom, left and right are defined so that the second container 2 side is up and the first container 1 side is down, the length in the left-right direction is the width, and the length in the top and bottom is the height. explain. The side portions are left and right end portions extending vertically.
The weak seal part does not peel easily during cleaning, dispensing, or sterilization of a multi-chamber infusion container, and in use, pressure is manually applied to the medicine filled in the chamber via the flexible material constituting the container. Thus, the seal portion can be easily peeled and communicated between a plurality of chambers without damaging the container body. The strong seal portion is a seal portion that cannot be peeled off during normal use.

本発明の複室輸液容器Yは可撓性材料からなる第1容器1及び第2容器2が連通可能な仕切部材4により一体化された複室輸液容器であって、第1容器1、第2容器2の間を仕切る仕切部材4を有している。
第1容器1には第2容器2の室より薬剤を多量に収容できる2つ以上の大室9、9と薬剤の排出及び/又は注入用のポート7が設けられている。第2容器2には第1容器1の室よりも小容量の小室10が2つ以上設けられている。ここで、大室9と小室10とは本発明における説明上の区分であり、大室9とは小室10よりも大容量であるとの意味であり、糖類製剤、蛋白質アミノ酸製剤及び血液代用剤などの比較的大容量の薬剤を収容するものである。これらの室の容量は特に限定されるものではないが、100mL程度がその境である。それぞれの室には液剤や粉剤の薬剤が収容される。本発明において、第1の小室とは、前記小室10の中、前記仕切部材に面する小室をいい、第2の小室とは弱シール部を介して前記第1の小室に隣接する小室をいい、第3の小室とは、弱シール部を介して前記第2の小室に隣接する第1の小室以外の小室をいう。
The multi-chamber infusion container Y of the present invention is a multi-chamber infusion container in which a first container 1 and a second container 2 made of a flexible material are integrated by a partition member 4 capable of communicating with each other. A partition member 4 that partitions the two containers 2 is provided.
The first container 1 is provided with two or more large chambers 9 and 9 that can accommodate a larger amount of medicine than the chamber of the second container 2 and a port 7 for discharging and / or injecting the medicine. The second container 2 is provided with two or more small chambers 10 having a smaller capacity than the chamber of the first container 1. Here, the large chamber 9 and the small chamber 10 are sections for explanation in the present invention, and the large chamber 9 means that the volume is larger than that of the small chamber 10, and is a saccharide preparation, a protein amino acid preparation, and a blood substitute. It accommodates a relatively large volume of medicine. The volume of these chambers is not particularly limited, but about 100 mL is the boundary. Each chamber contains a liquid medicine or a powder medicine. In the present invention, the first small chamber refers to a small chamber facing the partition member in the small chamber 10, and the second small chamber refers to a small chamber adjacent to the first small chamber via a weak seal portion. The third chamber is a chamber other than the first chamber adjacent to the second chamber through the weak seal portion.

図1に本発明の複室輸液容器の例を示す。
図1Aは、可撓性材料として合成樹脂製フィルムを用い、合成樹脂製フィルム2枚の周縁をヒートシールして強シール部3とした第1容器1及び第2容器2が一体化した袋状の容器である。第1容器1及び第2容器2は仕切部材4並びに第1容器上部の強シール部5及び第2容器下部の強シール部6で互いにつながり、一体化している。第1容器1の下部には内容物の排出や注入に用いられるポート7が溶着されている。図1Bは、図1Aの合成樹脂フィルム2枚に代えてインフレーション成形等によって得られる筒状フィルムを第1容器1及び第2容器2の両方に用いた例である。図1Bでは筒状フィルムの上下部分のみをヒートシールして強シール部3としている。図示しないが、第1容器または第2容器のどちらか片方のみを筒状フィルムとしてもよい。
FIG. 1 shows an example of a multi-chamber infusion container of the present invention.
In FIG. 1A, a synthetic resin film is used as a flexible material, and the periphery of two synthetic resin films is heat-sealed to form a strong seal portion 3, and the first container 1 and the second container 2 are integrated into a bag shape. The container. The first container 1 and the second container 2 are connected and integrated with each other by a partition member 4, a strong seal part 5 at the upper part of the first container, and a strong seal part 6 at the lower part of the second container. A port 7 used for discharging and injecting contents is welded to the lower portion of the first container 1. FIG. 1B is an example in which a cylindrical film obtained by inflation molding or the like is used for both the first container 1 and the second container 2 instead of the two synthetic resin films of FIG. 1A. In FIG. 1B, only the upper and lower portions of the tubular film are heat-sealed to form a strong seal portion 3. Although not shown, only one of the first container and the second container may be a tubular film.

(第1容器)
図1の下部に示した第1容器1は本発明の複室輸液容器Yに用いられる第1容器の例である。図1A、Bの例共に、第1容器1の内部は水平に延びた弱シール部8により2つの大室9、9に分けられている。
第1容器1の下部に溶着されたポート7は図5に示すように、代表的には円筒状の筒部材71の上部に、中空針が刺通可能なゴム栓などの弾性体72が装着されたものであり、内容物の排出や注入に用いられる。このポート7において、断面が中空円形の筒状部材のかわりに断面が楕円形、菱形及び舟形さらにこれらの組合さったものなどを用いることができ、さらに、硬質のポート7の代わりに柔軟なチューブでもよい。ポート7の材質については、少なくともその外表面が第1容器1の最内層と溶着可能な材質を選ぶことが好ましい。
本発明における第1容器の他の態様例として、図1に示す2つの大室9、9に代えて図2には大室が3室の例を示す。図1、図2に示す第1容器1の室は大室9の集合体であり、第2容器2の小室10に比べて大容量の内容物が収容される。第1容器1内に複数室を設けるときの大室同士の仕切部は従来のダブルバッグに使用されているのと同様の水平に延びる弱シール部8で仕切られている。
また、仕切手段として、弱シール部を使用することが仕切手段の連通後の迅速な混合が可能なため好ましいが、弱シール部に代えて、本願発明で用いられる仕切部材、パイプ折損方式、仕切治具方式などの仕切手段を採用してもよい。パイプ折損方式とは、仕切部の剥離不能なシール部に、端が閉塞された折損可能な管を挟持したものである。使用時に管を折損することによって連通する。仕切治具方式は、クリップなどの取り外し可能な仕切治具で可撓性シートを挟持することにより両室を仕切るようにしたものである。
(First container)
The 1st container 1 shown in the lower part of FIG. 1 is an example of the 1st container used for the multi-chamber infusion container Y of this invention. 1A and 1B, the inside of the first container 1 is divided into two large chambers 9 and 9 by a weak seal portion 8 extending horizontally.
As shown in FIG. 5, the port 7 welded to the lower portion of the first container 1 is typically provided with an elastic body 72 such as a rubber stopper through which a hollow needle can be inserted on the upper portion of a cylindrical cylindrical member 71. It is used for discharging and injecting contents. In this port 7, instead of a cylindrical member having a hollow circular cross section, an elliptical shape, a rhombus shape, a boat shape, or a combination thereof can be used, and a flexible tube can be used instead of the hard port 7. Good. As for the material of the port 7, it is preferable to select a material whose outer surface can be welded to the innermost layer of the first container 1.
As another example of the first container according to the present invention, FIG. 2 shows an example in which there are three large chambers instead of the two large chambers 9 and 9 shown in FIG. The chamber of the first container 1 shown in FIGS. 1 and 2 is an assembly of the large chamber 9, and contains a larger volume of content than the small chamber 10 of the second container 2. When a plurality of chambers are provided in the first container 1, the partitioning portion between the large chambers is partitioned by a weak seal portion 8 that extends horizontally, similar to that used in conventional double bags.
In addition, it is preferable to use a weak seal portion as the partition means because rapid mixing is possible after the partition means communicates, but instead of the weak seal portion, the partition member, pipe breakage method, partition used in the present invention can be used. You may employ | adopt partitioning means, such as a jig | tool system. In the pipe breakage method, a breakable tube having a closed end is sandwiched between non-peelable seal portions of a partition portion. Communicate by breaking the tube when in use. In the partitioning jig method, both chambers are partitioned by sandwiching a flexible sheet with a removable partitioning jig such as a clip.

(第2容器)
本発明における第2容器2は、第1容器1の大室9に比較して小容量の小室10を少なくとも2室有する袋状の容器である。第2容器2内の複数の小室10は、室周縁の仕切部が不測の力を受けやすい大室9に接していないため、大室9,9同士を仕切る弱シール部8が連通するより弱い力で連通する弱シール部11とすることができる。また、このため、形状の自由度が高まり任意の形状とすることができる。また、弱シール部11を形成しうる可撓性材料の最内面は、適度な剥離強度を有する弱シール部を形成できる特性を有することはもちろんのこと、内容物と直接接触するから、可撓性材料最内面から内容物への溶出物の無いこと、内容物を吸着しないこと及び内容物を分解させないことなどの要求特性をも合わせて満足することが要求される。しかし、本発明の第2容器2の小室10は、いずれも大室9に接していないため、適度な剥離強度を有する弱シール部を形成できる物性を有しているとの条件が緩和され、より幅広い材料からの選択が可能となる。これらのことにより、小室10には、10mL以下の小容量の内容物であっても、使用直前まで確実に分離して保持しておくことができる。
(Second container)
The second container 2 in the present invention is a bag-like container having at least two small chambers 10 having a small capacity as compared with the large chamber 9 of the first container 1. The plurality of small chambers 10 in the second container 2 are weaker than the weak seal portion 8 that partitions the large chambers 9 and 9 communicates with each other because the partitioning portion on the periphery of the chamber is not in contact with the large chamber 9 that is susceptible to unexpected force. It can be set as the weak seal part 11 connected by force. Moreover, for this reason, the freedom degree of a shape increases and it can be set as arbitrary shapes. In addition, the innermost surface of the flexible material that can form the weak seal portion 11 has a characteristic that it can form a weak seal portion having an appropriate peel strength, and is also in direct contact with the contents. It is required to satisfy the required characteristics such as the absence of eluate from the innermost surface of the functional material to the contents, the adsorption of the contents, and the decomposition of the contents. However, since none of the small chambers 10 of the second container 2 of the present invention are in contact with the large chamber 9, the condition of having a physical property capable of forming a weak seal portion having an appropriate peel strength is relaxed, A wider range of materials can be selected. As a result, even a small volume of 10 mL or less can be reliably separated and held in the small chamber 10 until just before use.

次に第2容器2の形状の例をいくつか挙げる。
図3Aは中央の仕切部材4に隣接する第1の小室10aと、上下方向に延びて、下端が第2容器下部の強シール部6に接続し、上端が強シール部6と相対する上端の強シール部3につながっている弱シール部11、11を介して前記第1の小室10aに隣接する2つの第2の小室10b、10bを有している。
第2容器2の全ての弱シール部11が、仕切部材4と接する第1の小室10aの周縁の弱シール部であるため、仕切部材4連通後に第1容器1から流入する薬剤が全ての弱シール部11に接し、第1容器1に加えられた力により発生した液圧が薬剤を通して第2容器2の全ての弱シール部11に直接付加され易く、第2容器内の弱シール部11、11が剥離しやすく、連通が容易である。薬剤の充填、封入については、例えば上方より全ての室へ薬剤を充填した後に、上部強シール部3を設けることで行うことができる。
Next, some examples of the shape of the second container 2 will be given.
FIG. 3A shows the first small chamber 10a adjacent to the central partition member 4 and the upper end of the upper end opposite to the strong seal portion 6 with the lower end connected to the strong seal portion 6 at the bottom of the second container and extending in the vertical direction. There are two second small chambers 10b, 10b adjacent to the first small chamber 10a via weak seal portions 11, 11 connected to the strong seal portion 3.
Since all the weak seal portions 11 of the second container 2 are weak seal portions on the periphery of the first small chamber 10a in contact with the partition member 4, all of the medicine flowing from the first container 1 after the partition member 4 communicates is weak. The liquid pressure generated by the force applied to the first container 1 in contact with the seal part 11 is easily applied directly to all the weak seal parts 11 of the second container 2 through the drug, and the weak seal parts 11 in the second container, 11 is easy to peel off and communication is easy. The filling and sealing of the medicine can be performed by, for example, providing the upper strong seal portion 3 after filling all the chambers from above.

図3Bは、全ての区画が弱シール部11,12で形成され、上下方向に延びる弱シール部11と幅方向に延びて弱シール部11と第2容器の幅方向端部を結ぶ弱シール部12が設けられ、中央の仕切部材4に隣接する第1の小室10aと、弱シール部11、12を介して前記第1の小室10aに隣接する2つの第2の小室10b、10bを有している。図3Bにおいては、弱シール部同士の交差部10Aがある。弱シール部同士の交差部10Aは、応力が集中し、薬液混合する必要がない場合でも少しの力がかかると剥離し易くなるが、このような弱シール部を剥離させる力は、通常、大量の薬液を封入された大室にかかる応力により発生するものであり、本願発明における第2容器2内部には、第1容器1で発生した力が仕切部材4により遮断されているため、交差部に力が働く可能性が極めて低くなる。従って、薬液混合直前まで安定して小室10a、10b、10bを仕切っておくことが可能である。   FIG. 3B shows that all the sections are formed by weak seal portions 11 and 12, and the weak seal portion 11 extending in the vertical direction and the weak seal portion extending in the width direction and connecting the weak seal portion 11 and the widthwise end of the second container. 12 and has a first small chamber 10a adjacent to the central partition member 4 and two second small chambers 10b and 10b adjacent to the first small chamber 10a via weak seal portions 11 and 12. ing. In FIG. 3B, there is an intersecting portion 10A between weak seal portions. The crossing portion 10A between the weak seal portions tends to be peeled off when a little force is applied even when the stress is concentrated and it is not necessary to mix the chemicals. However, the force for peeling off such a weak seal portion is usually a large amount. Is generated by the stress applied to the large chamber filled with the chemical solution, and the force generated in the first container 1 is blocked by the partition member 4 in the second container 2 in the present invention. The possibility that the force will work is extremely low. Therefore, it is possible to partition the small chambers 10a, 10b, and 10b stably until just before the chemical solution is mixed.

図3C及び図3Dは、上下方向に延びる2つの弱シール部11で第2容器2が3つの区画に区切られ、その区画の一つが幅方向に延びる弱シール部12で仕切られ、合計4つの室が設けられている例である。これらの場合も、中央の仕切部材4に隣接する第1の小室10a以外の各小室10は第1の小室10aに弱シール部11,12を介して隣接しており、第2の小室10bとなっている。
図示はしていないが、図3Dの第1の小室以外の区画がそれぞれ幅方向に延びるシールで仕切られ、合計5つの小室が設けられていてもよい。
3C and 3D, the second container 2 is divided into three sections by two weak seal portions 11 extending in the vertical direction, and one of the sections is partitioned by the weak seal sections 12 extending in the width direction. This is an example in which a chamber is provided. Also in these cases, each of the small chambers 10 other than the first small chamber 10a adjacent to the central partition member 4 is adjacent to the first small chamber 10a via the weak seal portions 11 and 12, and the second small chamber 10b. It has become.
Although not shown, the sections other than the first small chamber in FIG. 3D may be partitioned by seals extending in the width direction, and a total of five small chambers may be provided.

図3Eは、図3Aの構成と類似の弱シール部が設けられているが、この例の弱シール部13は上下方向に対して傾斜し、仕切部材4に隣接する第1の小室10aが下方より上方が狭くされた左右対称の台形状の室となっている。第2容器下部の強シール部6と弱シール部13の交差部18の第1の小室10a側の角度は鋭角となっているため、第1の小室10aから液圧が加わった時に図3Aの第2容器の弱シール部11よりも剥離し易い。従って、第2容器内の弱シール部13が一部剥離しなかった場合でも、少なくともこの交差部18は剥離する。該交差部18は第2容器2の最下部に位置しているため、第2容器2内の薬剤は確実に第1容器1内に流入することが可能である。   In FIG. 3E, a weak seal portion similar to the configuration of FIG. 3A is provided, but the weak seal portion 13 in this example is inclined with respect to the vertical direction, and the first small chamber 10a adjacent to the partition member 4 is downward. It is a symmetrical trapezoidal chamber with a narrower upper part. Since the angle on the first small chamber 10a side of the intersecting portion 18 of the strong seal portion 6 and the weak seal portion 13 at the lower portion of the second container is an acute angle, when hydraulic pressure is applied from the first small chamber 10a, FIG. It is easier to peel off than the weak seal portion 11 of the second container. Therefore, even when the weak seal portion 13 in the second container is not partially peeled, at least the intersection 18 is peeled off. Since the intersection 18 is located at the lowermost part of the second container 2, the medicine in the second container 2 can surely flow into the first container 1.

図3Fは第2容器2の下部の強シール部6′の高さが、第2容器2の下方において、側面側より中央部側が低くなるように設けられ、強シール部6′の中央の低い位置に仕切り部材4が設けられている。これにより第1容器1及び第2容器2内の薬剤を混合した後の混合済みの薬剤が残ることなく第1容器1の下部の排出口(仕切部材4)から排出されるという効果を有する。
図3Gは、図3Eと図3Fの考えを組合せた例である。即ち、第2容器2の下部の強シール部6′の高さが、第2容器2の下方において、側面側より中央部側が低くなるように設けられ、強シール部6′の中央の低い位置に仕切り部材4が設けられているとともに、弱シール部13は上下方向に対して傾斜し、仕切部材4に接する第1の小室10aが下方より上方の幅が狭くされた左右対称の形状の室になっている。
FIG. 3F shows that the height of the strong seal portion 6 ′ at the lower part of the second container 2 is provided below the second container 2 so that the center side is lower than the side surface side, and the center of the strong seal portion 6 ′ is low. A partition member 4 is provided at the position. Accordingly, there is an effect that the mixed medicine after mixing the medicines in the first container 1 and the second container 2 is discharged from the discharge port (partition member 4) at the lower part of the first container 1 without remaining.
FIG. 3G is an example combining the ideas of FIG. 3E and FIG. 3F. That is, the height of the strong seal portion 6 ′ at the lower portion of the second container 2 is provided below the second container 2 so that the center portion side is lower than the side surface side, and the lower position at the center of the strong seal portion 6 ′. The partition member 4 is provided, the weak seal portion 13 is inclined with respect to the vertical direction, and the first small chamber 10a in contact with the partition member 4 has a symmetrical shape in which the upper width is narrowed from below. It has become.

図3H及び図3Iは、第1容器1と第2容器2とを連通可能に仕切る仕切部材の位置を左側の小室10a側に設けた例である。図3Hの例では、仕切部材4がほぼ中央部にあり、左の小室10aが右の小室10bより大きくなっている。このように、第2容器2に注入する薬液の量に応じて小室10の大きさを適宜設定することができる。図3Iに示すように仕切部材4は幅方向において必ずしも中央部に位置させる必要はなく、適宜仕切部材の位置を選ぶことができる。   3H and 3I are examples in which the position of the partition member that partitions the first container 1 and the second container 2 so as to communicate with each other is provided on the left small chamber 10a side. In the example of FIG. 3H, the partition member 4 is substantially in the center, and the left small chamber 10a is larger than the right small chamber 10b. As described above, the size of the small chamber 10 can be appropriately set according to the amount of the chemical solution injected into the second container 2. As shown in FIG. 3I, the partition member 4 does not necessarily have to be positioned at the center in the width direction, and the position of the partition member can be selected as appropriate.

図3Jは、室が強シール部と弱シール部で区画して形成された例である。第2容器2の全幅にわたって延びる幅方向の弱シール部12と上下方向に上端の強シール部3から延びる第2の強シール部14が弱シール部12に当接する位置まで設けられ、仕切部材4に隣接する第1の小室10aと、弱シール部を介して第1の小室10aに隣接する第2の小室10bを有している例である。2つの第2の小室10bの間は第2の強シール部14で仕切られている。この例では、強シール部に比較して製造の難易度の高い弱シール部12が1箇所であり、生産するうえでの歩留まりを高く維持することが可能となる。図3Jでは上端から延びる第2の強シール部14が1本であるが、この第2の強シール部14を複数本設け、上端部に接する小室10bを3つ以上設けることもできる。本発明における第2容器であれば、前記のような第2の強シール部14の数が増えても完全混合までの容易さは変わらない。   FIG. 3J shows an example in which a chamber is formed by partitioning a strong seal portion and a weak seal portion. The partition member 4 is provided up to a position where the weak seal portion 12 in the width direction extending over the entire width of the second container 2 and the second strong seal portion 14 extending from the strong seal portion 3 at the upper end in the vertical direction abut against the weak seal portion 12. This is an example having a first small chamber 10a adjacent to the first small chamber 10a and a second small chamber 10b adjacent to the first small chamber 10a via a weak seal portion. The two second small chambers 10 b are partitioned by the second strong seal portion 14. In this example, there is one weak seal portion 12 that is more difficult to manufacture than the strong seal portion, and it is possible to maintain a high yield in production. In FIG. 3J, there is one second strong seal portion 14 extending from the upper end. However, a plurality of second strong seal portions 14 may be provided, and three or more small chambers 10b contacting the upper end portion may be provided. If it is the 2nd container in this invention, even if the number of the above 2nd strong seal parts 14 increases, the ease to complete mixing does not change.

図3Kは、仕切部材4の第2容器側の端を強シール部6′の第2容器側の端より低くし、仕切部材を挟んで設けられた第2容器下端の2つの強シール部6′、6′の仕切部材4に面する両端を結ぶように弱シール部15を設け、この弱シール部15と、強シール部6′、6′、仕切部材4に囲まれた第1の小室10aを形成している。
また、仕切部材4を挟んで両側の強シール部6′、6′のそれぞれから前記第2容器の上部の強シール部3まで斜め方向に延びる弱シール部13、13が設けられ、これらの3つの弱シール部13、13、15と強シール部6′、6′に相対する上端強シール部3に囲まれて第2の小室10bが形成されている。この第2の小室10bは前記第1の小室10aに弱シール部15を介して隣接している。第2の小室10bの両側にはそれぞれ第2の小室に隣接する第3の小室10cが設けられ、第2容器2には合計4つの小室が設けられている。第1の小室10aは容積が非常に小さいため、仕切部材の薄肉部を破断させた後には、第1の小室10aと第2の小室10bの間の弱シール部15は簡単に剥離し、図3Eに示したものとほぼ同様に第1容器を一回押圧することにより、第1容器1及び第2容器2内の全ての室が確実に連通可能となる。
In FIG. 3K, the end of the partition member 4 on the second container side is made lower than the end of the strong seal portion 6 'on the second container side, and the two strong seal portions 6 at the lower end of the second container provided with the partition member interposed therebetween. A weak seal portion 15 is provided so as to connect both ends of the partition members 4 'and 6' facing each other, and the first seal chamber surrounded by the weak seal portion 15 and the strong seal portions 6 'and 6' and the partition member 4 is provided. 10a is formed.
In addition, weak seal portions 13 and 13 extending obliquely from the strong seal portions 6 'and 6' on both sides across the partition member 4 to the strong seal portion 3 on the upper side of the second container are provided. A second small chamber 10b is formed by being surrounded by the two weak seal portions 13, 13, 15 and the upper end strong seal portion 3 facing the strong seal portions 6 ', 6'. The second small chamber 10b is adjacent to the first small chamber 10a via a weak seal portion 15. A third small chamber 10c adjacent to the second small chamber is provided on both sides of the second small chamber 10b, and a total of four small chambers are provided in the second container 2. Since the first small chamber 10a has a very small volume, the weak seal portion 15 between the first small chamber 10a and the second small chamber 10b is easily peeled off after the thin portion of the partition member is broken. By pressing the first container once in substantially the same manner as shown in 3E, all the chambers in the first container 1 and the second container 2 can be reliably communicated.

図3Lは、全ての室が弱シール部で区画して形成され、第2容器2の全幅で幅方向に延びる弱シール部12,16が2つ設けられ、仕切部材4に隣接する第1の小室10a、弱シール部12を介して第1の小室10aに隣接する10b、弱シール部16を介して第2の小室10bに隣接する第3の小室10cを有している。また、上部の弱シール部16はその一部に角部を有する屈曲部17を有し、下部の弱シール部12より剥離しやすいものとなっている。また、図示しないが、幅方向に広がる弱シール部を、中央部が低く側部が高くなるように傾斜をつける様にシールすると、弱シール部全幅に渡って剥離しなかった場合でも、薬剤が第2容器内部に滞留することなく、第1容器に流れ込むため、好ましい。薬剤の充填、封入については、上部の強シール部3を作成した後に側部より全ての室へ薬剤を充填した後に側部を強シールすることで行うことができる。   In FIG. 3L, all the chambers are formed by partitioning with weak seal portions, two weak seal portions 12, 16 extending in the width direction with the full width of the second container 2 are provided, and the first adjacent to the partition member 4 is provided. It has a small chamber 10a, 10b adjacent to the first small chamber 10a via the weak seal portion 12, and a third small chamber 10c adjacent to the second small chamber 10b via the weak seal portion 16. Further, the upper weak seal portion 16 has a bent portion 17 having a corner portion at a part thereof, and is easily peeled off from the lower weak seal portion 12. In addition, although not shown, if the weak seal portion spreading in the width direction is sealed so as to be inclined so that the central portion is low and the side portion is high, the drug is not peeled even if the weak seal portion does not peel over the entire width. This is preferable because it flows into the first container without staying inside the second container. The filling and sealing of the medicine can be performed by forming the upper strong seal portion 3 and then strongly filling the side portions after filling the chambers with the medicine from all the sides.

図3Mは仕切部材4を一方の側部に寄せて配置し、縦方向に延びる2本の弱シール部11、11′で第2容器内を3つに区画して、仕切部材4に隣接する第1の小室10a、弱シール部11を介して第1の小室10aに隣接する10b、弱シール部11′を介して第2の小室10bに隣接する第3の小室10cを設けた例である。   In FIG. 3M, the partition member 4 is arranged close to one side, and the inside of the second container is divided into three by two weak seal portions 11 and 11 ′ extending in the vertical direction and adjacent to the partition member 4. This is an example in which a first small chamber 10a, 10b adjacent to the first small chamber 10a via the weak seal portion 11 and a third small chamber 10c adjacent to the second small chamber 10b via the weak seal portion 11 ′ are provided. .

図3Nは、第2容器下端強シール部の中央部に設けられた仕切部材と、仕切部材の両端の強シール部から斜め上方に伸びて、第2容器側部の強シール部につながる弱シール部19、19を有し、弱シール部と第2容器上端の強シール部の間に、仕切部材4に隣接する第1の小室が設けられ、弱シール部19を介して第1の小室10aに隣接する第2の小室10bが設けられた例である。
図3Oは第2容器の上端部及び両側部の強シール部の代わりに上に凸の弧状をしている強シール部を設けた例であり、第2容器下端強シール部の中央部に設けられた仕切部材と、仕切部材の両端の強シール部からそれぞれ斜め上方に伸びて、弧状強シール部につながる弱シール部20、20が設けられている。これにより第2容器中央に仕切部材4に隣接する第1の小室10aと、弱シール部20を介して前記第1の小室10aに隣接する第2の小室
第2容器の他の態様については、当業者であれば上述の例に基づき様々に変化させることは容易である。
3N shows a partition member provided at the center of the second container lower end strong seal portion, and a weak seal extending obliquely upward from the strong seal portions at both ends of the partition member and connected to the strong seal portion on the second container side portion. A first small chamber adjacent to the partition member 4 is provided between the weak seal portion and the strong seal portion at the upper end of the second container, and the first small chamber 10a is interposed via the weak seal portion 19. This is an example in which a second small chamber 10b adjacent to is provided.
FIG. 3O is an example in which a strong seal portion having a convex arc shape is provided in place of the strong seal portions at the upper end portion and both side portions of the second container, and is provided at the central portion of the second container lower end strong seal portion. The partition member and the weak seal portions 20 and 20 extending obliquely upward from the strong seal portions at both ends of the partition member and connected to the arc-shaped strong seal portion are provided. Thereby, the first small chamber 10a adjacent to the partition member 4 in the center of the second container, and the second small chamber adjacent to the first small chamber 10a via the weak seal portion 20, Those skilled in the art can easily make various changes based on the above-described example.

図3E、図3G、図3Kの例の様な強シール部と弱シール部との鋭角部18、図3Lの様な弱シール部の角部を有する屈曲部17は応力集中部となるため、室内部の内圧が高くなった際に、最初に剥離する部分となる。
従来例に見られる弱シール部のみにより区画された、小室大室を組合せた多室の複室容器は大室と小室が弱シール部を介して接しており大室に加わった不測の力が弱シール部に加わるため、大室と小室を混合前まで安定に分離しておくことが困難であった。そこで、上述の様な応力集中部は、使用されるまでの安定した分離保管のため通常は避けて設計されるが、本発明の複室輸液容器は、大容量の室と小容量の室が仕切部材により完全に仕切られているため、仕切部材が連通する前に大容量の室で発生した力が小容量の室を区画するシール部に加わることがなく、大容量、小容量を区画するシール部よりも剥離しやすいシール部を第2容器に採用することが可能であり、第2容器の設計の自由度が高まり、かつ迅速で確実な完全混合が可能となっている。
従って、本発明の複室輸液容器において、第2容器は、小室のみからなる第2容器とすることが好ましく、大室のみからなる第1容器及び小室のみからなる第2容器の組み合わせとすることがより好ましい。
3A, 3G, and 3K, the acute angle portion 18 of the strong seal portion and the weak seal portion, and the bent portion 17 having the corner portion of the weak seal portion as shown in FIG. When the internal pressure in the interior increases, it becomes the part that peels first.
The multi-chamber multi-chamber container that combines a small chamber and a large chamber divided only by the weak seal portion seen in the conventional example is in contact with the large chamber and the small chamber through the weak seal portion, and there is an unexpected force applied to the large chamber. Since it is added to the weak seal portion, it is difficult to stably separate the large chamber and the small chamber before mixing. Therefore, the stress concentration portion as described above is usually designed to be avoided for stable separation and storage until it is used. However, the multi-chamber infusion container of the present invention has a large-capacity chamber and a small-capacity chamber. Since it is completely partitioned by the partition member, the force generated in the large-capacity chamber before the partition member communicates is not applied to the seal portion that partitions the small-capacity chamber, so that the large-capacity and small-capacity are partitioned. A seal part that is easier to peel than the seal part can be employed in the second container, the degree of freedom in designing the second container is increased, and rapid and reliable complete mixing is possible.
Therefore, in the multi-chamber infusion container of the present invention, the second container is preferably a second container consisting only of a small chamber, and a combination of a first container consisting only of a large chamber and a second container consisting only of a small chamber. Is more preferable.

図3のうちA〜J及びN〜Oに示した例は、第2容器2内における第1の小室10a以外の全ての小室10bが弱シール部を介して第1の小室10aと接している。このため、仕切部材4の連通後に第1容器から流入した内容物が、全ての小室10bの周縁の弱シール部のうち、少なくとも一部の弱シール部に直接触れるため、使用時には迅速に剥離し、迅速な完全混合が可能となるため好ましい。
さらに、これらA〜J及びN〜Oに示した例のうち、A、E〜J及びN〜Oに示した例は、第2容器の全ての弱シール部が、仕切部材に隣接する第1の小室10aの周縁の弱シール部である。即ち、B〜Dに示した例には仕切部材に隣接する第1の小室10aの周縁の弱シール部ではない弱シール部が第2容器内に存在するが、A、E〜J及びN〜Oに示した例は第1の小室10aの周縁以外の弱シール部は、第2容器内に存在しない。このため、仕切部材4の連通後に第1容器から流入した内容物が、第2容器内の全ての弱シール部に直接触れるため、さらに迅速に剥離し、さらに迅速な完全混合が可能となり、より好ましい。
In the example shown in A to J and N to O in FIG. 3, all the small chambers 10 b other than the first small chamber 10 a in the second container 2 are in contact with the first small chamber 10 a through the weak seal portion. . For this reason, since the content flowing in from the first container after the partition member 4 communicates directly touches at least a part of the weak seal portions at the peripheral edge of all the small chambers 10b, it peels off quickly during use. This is preferable because rapid and complete mixing is possible.
Furthermore, among the examples shown in A to J and N to O, the examples shown in A, E to J, and N to O are the first in which all weak seal portions of the second container are adjacent to the partition member. It is the weak seal part of the periphery of the small chamber 10a. That is, although the weak seal part which is not the weak seal part of the periphery of the 1st small chamber 10a adjacent to a partition member exists in the 2nd container in the example shown to B-D, A, E-J, and N- In the example shown by O, the weak seal part other than the periphery of the first small chamber 10a does not exist in the second container. For this reason, since the contents that flowed in from the first container after the partition member 4 communicates directly touch all the weak seals in the second container, they can be peeled off more quickly and more quickly and completely mixed. preferable.

図3のうち、J以外の例は全て、第2容器内の小室に分ける区画が全て弱シール部である。複室輸液容器の室の区画を強シール部と弱シール部の組合せにより区画した場合には、強シール部の設け方によっては、容器内面同士を剥離する方向への動きが拘束され、数回の押圧操作が必要となりやすい。特に、小室の区画が小容量であればあるほど、強シール部が多ければ多いほどより強く拘束される。このため連通して完全混合にするのに時間がかかる。第2容器内の区画が全て弱シール部であれば、拘束されることもなく、剥離が容易となり迅速で確実な完全混合が容易に可能である。   In FIG. 3, all the examples other than J are all weakly sealed sections divided into small chambers in the second container. When the compartment of a multi-chamber infusion container is partitioned by a combination of a strong seal portion and a weak seal portion, depending on how the strong seal portion is provided, the movement in the direction of peeling the inner surfaces of the containers is restricted, and several times It is easy to require pressing operation. In particular, the smaller the compartment, the more the strong seal part, the stronger the restraint. For this reason, it takes time to communicate and complete mixing. If all of the compartments in the second container are weakly sealed portions, they are not restrained and can be easily peeled off, allowing quick and reliable complete mixing easily.

図3のうち、B、C、D、J及びLは、仕切部材と接する第2容器2内に幅方向に延びる弱シール部12がある。これら幅方向の弱シール部は、仕切部材4の厚みのため、仕切部材4から一定の距離をとって設けることが必要であるため、仕切部材4と接する第1の小室10aを小さくすることに限界がある。従って、第2容器2の大きさ、特に上下方向の高さによっては幅方向の弱シール部を設けるのが望ましくない場合がある。また、図3のうち、A、E、F、G、H、I及びMのように上下方向の弱シール部のみで小室を区画すれば、第2容器2の複数の室への充填を同時に一度に行うことが可能となり好ましい。   In FIG. 3, B, C, D, J and L have a weak seal portion 12 extending in the width direction in the second container 2 in contact with the partition member. Since these weak seal portions in the width direction need to be provided at a certain distance from the partition member 4 because of the thickness of the partition member 4, the first small chamber 10a in contact with the partition member 4 is made small. There is a limit. Therefore, depending on the size of the second container 2, particularly the height in the vertical direction, it may not be desirable to provide a weak seal portion in the width direction. Further, in FIG. 3, if the small chamber is defined only by the weak seal portion in the vertical direction like A, E, F, G, H, I and M, the plurality of chambers of the second container 2 can be filled simultaneously. This is preferable because it can be performed at a time.

また、第2容器の小室の内容物に応じて、小室の構造を最適化することが好ましい。後述のように、第1容器1、第2容器2を構成する材料は熱可塑性樹脂が用いられ、中でも比較的透明な熱可塑性樹脂が多く用いられるが、例えば抗生剤などの光、酸素、水分に対して分解しやすい内容物の場合、その外面を遮光性及び/またはバリア性の高いフィルム、アルミ箔などの遮光部材で覆うことが好ましい。さらに、ビタミンD、ビタミンA、ビタミンE、ビタミンK、ビタミンHなどの脂溶性ビタミンを収容する室には、脂溶性ビタミンに対して低吸着性のポリエーテルサルホンや環状ポリオレフィンなどをその内面に用いることが好ましい。   Moreover, it is preferable to optimize the structure of the chamber according to the contents of the chamber of the second container. As will be described later, a thermoplastic resin is used as a material constituting the first container 1 and the second container 2, and a relatively transparent thermoplastic resin is often used. For example, light such as antibiotics, oxygen, moisture, etc. In the case of a content that is easily decomposed, it is preferable to cover the outer surface with a light shielding member such as a film having high light shielding properties and / or barrier properties, and aluminum foil. Furthermore, in the room containing fat-soluble vitamins such as vitamin D, vitamin A, vitamin E, vitamin K, vitamin H, etc., polyethersulfone or cyclic polyolefin with low adsorptivity to fat-soluble vitamins is placed on the inner surface. It is preferable to use it.

複室輸液容器をほぼ全面にわたる全体を大きなフィルムを区画して室を作る場合には、特定の内容物のために最適化すると内面全てを同一材質とする必要があるため、ポリオレフィン以外のより高価な材料を多く使用することとなり、コストアップなどの原因にもなるが、本発明においては第2容器2の内面のみの最適化で十分であり、最適化のために必要な材料が少なくて済むため好ましい。
また、第2容器2を形成する可撓性材料の一部領域に紫外線吸収性インクなどによる印刷を施すことにより、予め特定の室の薬剤を保護する様にすることも好ましい。
When a chamber is made by dividing a large-sized multi-chamber infusion container over the entire surface into a large film, it is necessary to use the same material for the entire inner surface when optimized for specific contents. However, in the present invention, it is sufficient to optimize only the inner surface of the second container 2 and less material is required for the optimization. Therefore, it is preferable.
In addition, it is also preferable to preliminarily protect the medicine in a specific chamber by performing printing with ultraviolet absorbing ink or the like on a partial region of the flexible material forming the second container 2.

また、図示はしていないが、第2容器2の少なくとも一つの室に、混注用のポート等の注入口を設けることも好ましい。
本発明の複室輸液容器は、種々の薬剤を分離して収容することが可能であるものの、多くの薬剤の組合せを考慮した、多種類の薬剤入り複室輸液容器を用意することは必ずしも現実的ではないと思われる。そこで、第2容器2の1室を混注用の注入口が設けられた空室並びに生理食塩水及び蒸留水など溶解液のみが充填された予備室とすることも好ましい態様である。予備室には、使用時に混注が必要な薬剤であって、他の薬剤と長時間混合して放置しておくことが望ましくない薬剤を、予め分離した状態で収容し保持しておくことが可能である。従って、無菌的環境の下で、予備室への薬剤の充填をまとめて複数の複室輸液容器に対して行うことができる。これにより、投与する度に毎回混注する作業が必要無くなり、医療機関における投薬調剤時の負担軽減、細菌汚染防止、異物混入防止、調剤時の過誤防止、緊急時の迅速な対応を可能にするなどのキット製品の利点が活かされた、患者の病体に応じた多種の薬剤入り複室輸液容器を準備しておくことが可能となり、在宅療法が可能な範囲が広がるなどの利点があり、極めて有用である。このような予備室を設ける態様は、本発明の多室化が容易な複室容器により可能となるものであり、本発明の好ましい適用例である。
Although not shown, it is also preferable to provide an injection port such as a mixed injection port in at least one chamber of the second container 2.
Although the multi-chamber infusion container of the present invention can separate and accommodate various drugs, it is not always realistic to prepare a multi-chamber multi-chamber infusion container considering various combinations of drugs. I don't think so. Therefore, it is also a preferred aspect that one chamber of the second container 2 is a vacant chamber provided with a mixed injection port and a spare chamber filled only with a solution such as physiological saline and distilled water. It is possible to store and hold drugs that need to be mixed at the time of use and are not desirable to be mixed with other drugs for a long time in the spare room. It is. Therefore, under a sterile environment, the filling of the medicine into the spare chamber can be performed collectively for a plurality of multi-chamber infusion containers. This eliminates the need for co-infusion every time it is administered, reduces the burden of dispensing at medical institutions, prevents bacterial contamination, prevents foreign matter contamination, prevents errors during dispensing, and enables quick response in emergencies. The advantage of the kit product is that it is possible to prepare a multi-chamber infusion container containing various drugs according to the patient's pathology, which has the advantage that the range of home therapy can be expanded and extremely useful It is. Such an embodiment in which the spare chamber is provided is made possible by the multi-chamber container in which the multi-chamber of the present invention can be easily formed, and is a preferable application example of the present invention.

(可撓性材料)
本発明における第1容器1及び第2容器2の本体に用いられる可撓性材料は、内容物の排出を容易にするための可撓性、内容物確認のための透明性、高圧蒸気殺菌のための耐熱性を有する材質からなるものである。この可撓性材料は主に合成樹脂製の単層または多層のフィルムまたはシートからなる。材料としては、例えば、ポリエチレン、ポリプロピレン等のポリオレフィン、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレート、脂環式コポリエステル等のポリエステル、エチレン−酢酸ビニル共重合体及びそのけん化物、ポリアミド樹脂、塩化ビニル、ポリ塩化ビニリデン、ポリエーテルサルホン並びに環状ポリオレフィンなどの熱可塑性樹脂が挙げられる。
(Flexible material)
The flexible material used for the main body of the first container 1 and the second container 2 in the present invention is flexible for easy discharge of contents, transparent for confirmation of contents, and high-pressure steam sterilization. Therefore, it is made of a material having heat resistance. This flexible material mainly consists of a single layer or multilayer film or sheet made of synthetic resin. Examples of materials include polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, and alicyclic copolyesters, ethylene-vinyl acetate copolymers and saponified products thereof, polyamide resins, and vinyl chloride. , Thermoplastic resins such as polyvinylidene chloride, polyethersulfone, and cyclic polyolefin.

容器を形成する袋体は、図1Aの例では、第1容器1及び第2容器2がインフレーション成形で得られる筒状フィルムを切断したフィルム、Tダイ成形で得られるフラットフィルムをそのまま、または、さらにラミネーション成形等によって得られる2枚のフィルムの周縁をヒートシールして強シール部としたものである。
別の例として、第1容器をブロー成形で得たものが挙げられる。その例を図7に示す。この場合、仕切部材と一体成形してもよい。
In the example of FIG. 1A, the bag forming the container is a film obtained by cutting the cylindrical film obtained by inflation molding of the first container 1 and the second container 2, and a flat film obtained by T-die molding, or Further, the periphery of two films obtained by lamination molding or the like is heat sealed to form a strong seal portion.
Another example is one obtained by blow molding the first container. An example is shown in FIG. In this case, it may be integrally formed with the partition member.

また、第1容器1と第2容器2は、それぞれに収容される薬剤との適性など考慮し、異なる材質からなる可撓性材料を用いることができる。可撓性材料は仕切部材4、ポート7、第1容器1及び第2容器2とそれぞれ溶着可能な材質、層構成のものであることが好ましい。さらに前述した様に内容物の吸着性などを考慮し適宜選択すればよい。   In addition, the first container 1 and the second container 2 can be made of flexible materials made of different materials in consideration of suitability of the medicines contained therein. The flexible material is preferably a material and a layer structure that can be welded to the partition member 4, the port 7, the first container 1 and the second container 2, respectively. Further, as described above, the content may be appropriately selected in consideration of the adsorptivity of the contents.

(仕切部材)
本発明における仕切部材4は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記仕切部材の連結部には破断可能な薄肉部を有するものである。この筒部材の中央部には隣接する2つの容器を連通可能に接続する中空部が設けられていれば、連通部の断面形状は任意の形状とすることができる。
仕切部材の具体的な例を図4に示す。
(Partition member)
The partition member 4 in the present invention can be ruptured into a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that liquid-tightly partitions two adjacent containers, and a connecting portion between the partition body and the partition member It has a thin part. If the hollow part which connects two adjacent containers so that communication is possible is provided in the center part of this cylinder member, the cross-sectional shape of a communication part can be made into arbitrary shapes.
A specific example of the partition member is shown in FIG.

図4(A)の仕切体は筒部材の端に設けられ、筒部材に蓋をする形となっている。仕切部材4は、前記第1容器1および第2容器2の幅方向に長尺で、容器の厚さ方向に扁平な筒部材を有する。この仕切部材4には、上面から底面に連通する中空部41を有する筒部材43と、この中空部41の底面側を封止する帯状の仕切体42が形成され、仕切部材42と筒部材43との連結部には、薄肉部が形成され、仕切部材4の中空部41には、支持部材46が挿入されている。薄肉部の一部には厚肉部が形成されている。また、筒部材43の幅方向端部43aは、舟形状であり、筒部材43の両表面側から傾斜する2面の傾斜面43bが形成されている。また、仕切体42の中空部41側表面には、仕切体42の幅方向に沿った複数のリブ47が設けられている。   The partition in FIG. 4A is provided at the end of the cylindrical member and has a shape that covers the cylindrical member. The partition member 4 has a cylindrical member that is long in the width direction of the first container 1 and the second container 2 and flat in the thickness direction of the container. The partition member 4 is formed with a cylindrical member 43 having a hollow portion 41 communicating from the upper surface to the bottom surface, and a strip-shaped partition body 42 that seals the bottom surface side of the hollow portion 41, and the partition member 42 and the cylindrical member 43 are formed. A thin portion is formed at the connecting portion, and a support member 46 is inserted into the hollow portion 41 of the partition member 4. A thick part is formed in a part of the thin part. The width direction end 43a of the cylindrical member 43 has a boat shape, and two inclined surfaces 43b that are inclined from both surface sides of the cylindrical member 43 are formed. A plurality of ribs 47 are provided on the surface of the partition body 42 on the hollow portion 41 side along the width direction of the partition body 42.

前記仕切体42と筒部材43との連結部に形成される薄肉部は、仕切部材4に対する外部からの変形操作によって破断可能とされた部分であり、厚肉部は、外部からの変形操作によっても破断せずに仕切体42と筒部材43とを連結するためのものである。薄肉部の厚さは、0.1〜0.2mmであることが好ましい。薄肉部44の厚さが0.1mm未満では、薬剤12の自重や第1容器1のレトルト殺菌時の内圧により破断してしまうおそれがあり、0.2mmを超えると、仕切部材4の変形操作時に不必要に高い力が必要となるため適切ではない。   The thin portion formed in the connecting portion between the partition body 42 and the cylindrical member 43 is a portion that can be broken by an external deforming operation on the partition member 4, and the thick portion is formed by an external deforming operation. Also, the partition 42 and the cylindrical member 43 are connected without breaking. The thickness of the thin portion is preferably 0.1 to 0.2 mm. If the thickness of the thin portion 44 is less than 0.1 mm, there is a risk of breaking due to the own weight of the drug 12 or the internal pressure during retort sterilization of the first container 1. It is not appropriate because sometimes it requires an unnecessarily high force.

前記筒部材43の幅方向端部43aに形成された傾斜面43b、43bは、例えば、仕切部材4と第1容器1の上端とをヒートシールする際、第1容器1を形成している2枚の合成樹脂製のフィルムと仕切部材4とを隙間なく溶着させるためのものである。筒部材43の幅方向端部43aが曲面の場合、2枚の合成樹脂製のフィルムと筒部材43の側面との間にピンホールが生じるおそれがある。前記リブ47は、仕切体42の幅方向の強度を高め、外部からの変形操作によって加わる外力に対して仕切体42および筒部材43から生じる応力の差を大きくし、仕切体42の筒部材43から剥がれるのを促すためのものである。また、リブ47は、仕切体42が筒部材43から剥がれた後、筒部材43の端面と接触し、引っ掛かりとなることによって、第1容器内の薬剤と第2容器内の薬剤の混合時に仕切体42が再び中空部41を封止するのを防止するためのものである。   The inclined surfaces 43b and 43b formed in the width direction end 43a of the cylindrical member 43 form the first container 1 when heat-sealing the partition member 4 and the upper end of the first container 1, for example. It is for welding the sheet of synthetic resin and the partition member 4 without a gap. When the width direction end portion 43 a of the cylindrical member 43 is a curved surface, a pinhole may occur between the two synthetic resin films and the side surface of the cylindrical member 43. The rib 47 increases the strength in the width direction of the partition 42, increases the difference in stress generated from the partition 42 and the tubular member 43 with respect to external force applied by an external deformation operation, and the tubular member 43 of the partition 42. It is intended to encourage peeling. In addition, the rib 47 comes into contact with the end surface of the cylindrical member 43 after the partition body 42 is peeled off from the cylindrical member 43 and becomes caught, thereby separating the drug in the first container and the drug in the second container. This is to prevent the body 42 from sealing the hollow portion 41 again.

このような仕切部材4にあっては、図4(A)に示すように、仕切部材4の両側の幅方向端部43aに、容器の厚さ方向に同一方向の力を加え、同時に仕切部材4の幅方向中央部に、幅方向端部43aとは逆方向に力を加えて、仕切部材4をくの字形に屈曲させることによって、外力に対して仕切体42および筒部材43からそれぞれ異なる応力が生じ、この応力の差によって仕切体42と筒部材43との連結部に形成された薄肉部を破断させることができ、仕切体42を仕切部材4の外側に開かせることができる。このようにして、第1容器1と第2容器2とが連通され、第1容器内の薬剤と第2容器内の薬剤を混合することができるようになる。このとき、蓋体42は、薄肉部の一部に設けられた厚肉部によって仕切部材本体43と連結しているので脱落を防止することができる。   In such a partition member 4, as shown to FIG. 4 (A), the force of the same direction is applied to the width direction edge part 43a of the both sides of the partition member 4 in the thickness direction of a container, and it is simultaneously a partition member 4 by applying a force in the direction opposite to the width direction end portion 43a to the width direction center portion 4 to bend the partition member 4 in a dogleg shape, thereby different from the partition body 42 and the cylindrical member 43 with respect to external force. Stress is generated, and the thin portion formed at the connecting portion between the partition body 42 and the cylindrical member 43 can be broken by the difference in stress, and the partition body 42 can be opened to the outside of the partition member 4. Thus, the 1st container 1 and the 2nd container 2 are connected, and the chemical | medical agent in a 1st container and the chemical | medical agent in a 2nd container can be mixed now. At this time, since the lid body 42 is connected to the partition member main body 43 by the thick part provided in a part of the thin part, it can be prevented from falling off.

図4(B)、(C)は、仕切部材4の他の例を示す図である。(B)は斜視図、(C)は側面図を示す。
図4(B)、(C)に示す仕切部材4′は筒部材43の中空部41の中央部を仕切る仕切体42を有し、前記仕切体42と前記筒部材43との連結部には、仕切部材42が力を受けたときに破断可能な薄肉部44が形成されている。
図4(B)の筒部材43の連通部の断面形状は図4(A)の筒部材43と同じ形状になっている。
仕切体42は、筒部材43内面に薄肉部44を介して保持され、中空部41を仕切り、容器内容物を使用する前まで確実に分離する部材であり、仕切部材4と容器を溶着する際に、薄肉部44と共に仕切部材4が変形することを防止する作用をも有している。
FIGS. 4B and 4C are diagrams showing another example of the partition member 4. (B) is a perspective view and (C) is a side view.
A partition member 4 ′ shown in FIGS. 4B and 4C has a partition body 42 that partitions the central portion of the hollow portion 41 of the tubular member 43, and a connecting portion between the partition body 42 and the tubular member 43 is provided at the connection portion. A thin portion 44 that can be broken when the partition member 42 receives force is formed.
The cross-sectional shape of the communicating portion of the cylindrical member 43 in FIG. 4B is the same as that of the cylindrical member 43 in FIG.
The partition body 42 is a member that is held on the inner surface of the cylindrical member 43 via the thin wall portion 44, partitions the hollow portion 41, and reliably separates the container contents before using them. When the partition member 4 and the container are welded, In addition, it has the function of preventing the partition member 4 from being deformed together with the thin portion 44.

筒部材43の中空部41には、少なくとも1つの支持部材46が設けられていることが好ましい。図4(B)、(C)の例では支持部材46が2個設けられている。
この支持部材46は、中空部の幅方向に沿った複数のリブ46bと、このリブ46bの中心部を連結するように中空部41の長手方向に延びる連結部材46aとを有するものであり、この支持部材46により、仕切部材本体43と容器との溶着時の仕切部材本体43の変形をより確実に防止することができ、溶着時に過大な力が加わったときの薄肉部の変形や破損を防止することが可能となる。支持部材46の上下方向の長さは、特に限定されるものではないが、連通前の中空部41の上下方向の長さの1/4以下であることが好ましい。
It is preferable that at least one support member 46 is provided in the hollow portion 41 of the cylindrical member 43. In the example of FIGS. 4B and 4C, two support members 46 are provided.
The support member 46 includes a plurality of ribs 46b extending in the width direction of the hollow portion, and a connecting member 46a extending in the longitudinal direction of the hollow portion 41 so as to connect the central portion of the rib 46b. The support member 46 can more reliably prevent deformation of the partition member main body 43 when the partition member main body 43 and the container are welded, and prevent deformation and breakage of the thin portion when an excessive force is applied during welding. It becomes possible to do. The length in the vertical direction of the support member 46 is not particularly limited, but is preferably ¼ or less of the length in the vertical direction of the hollow portion 41 before communication.

図4(B)に示す仕切部材4′も、仕切部材4′の両側の幅方向端部に、容器の厚さ方向に同一方向の力を加え、同時に仕切部材4′の幅方向中央部に、幅方向端部とは逆方向に力を加えて、仕切部材4′をくの字形に屈曲させることによって、外力に対して仕切体42および筒部材43からそれぞれ異なる応力が生じ、この応力の差によって仕切体42と仕切部材本体43との連結部に形成されている薄肉部44を破断させることができる。図4(B)、(C)に示すように、支持部材46が仕切部材4の両側に2個設けられていると、薄肉部44の破断により仕切体42が筒部材43と遊離しても、支持部材46により遮られて中空部41から外の第2容器2側あるいは第1容器1側に出ることはない。
図4(A)、(B)に例示した仕切部材の断面はある程度扁平していることが要求されるから特に限定されるものではないが、幅/厚みが3以上であることが好ましく、また、人の手により力がかけられる様にすることが好ましく、幅3〜20cm程度とすることが好ましい。また、仕切部材を幅広の複室輸液容器の中央部に設けるときには、仕切部材の屈曲操作を容易にするために、図8(A)に示す様に仕切部材の両端に設けられた強シール部の少なくとも一方に複室輸液容器の表から裏へ指を挿入できる開口部を設けたり、図8(B)に示す様に仕切部材のみで第1容器と第2容器とを一体化させる様にしたりすることも好ましい。なお、図8(B)は、第1容器及び第2容器が仕切部材のみにより一体化されている複室輸液容器であるが、図1や図8に示すように仕切部材及び強シール部で一体化すれば、より強固に第1容器及び第2容器が一体化されるため好ましい。
The partition member 4 'shown in FIG. 4B also applies a force in the same direction in the thickness direction of the container to the width direction end portions on both sides of the partition member 4', and at the same time at the center portion in the width direction of the partition member 4 '. By applying a force in the direction opposite to the end in the width direction and bending the partition member 4 'into a dogleg shape, different stresses are generated from the partition member 42 and the cylindrical member 43 with respect to the external force, respectively. Due to the difference, the thin portion 44 formed at the connecting portion between the partition body 42 and the partition member main body 43 can be broken. As shown in FIGS. 4B and 4C, when two support members 46 are provided on both sides of the partition member 4, even if the partition body 42 is separated from the cylindrical member 43 due to the breakage of the thin portion 44. In addition, it is blocked by the support member 46 and does not exit from the hollow portion 41 to the outer side of the second container 2 or the first container 1.
The partition member illustrated in FIGS. 4 (A) and 4 (B) is not particularly limited because the cross-section of the partition member is required to be flat to some extent, but the width / thickness is preferably 3 or more. It is preferable that a force is applied by a human hand, and the width is preferably about 3 to 20 cm. Further, when the partition member is provided at the center of the wide multi-chamber infusion container, in order to facilitate the bending operation of the partition member, as shown in FIG. 8 (A), strong seal portions provided at both ends of the partition member. At least one of them is provided with an opening through which a finger can be inserted from the front to the back of the multi-chamber infusion container, or as shown in FIG. 8B, the first container and the second container are integrated with only the partition member. Is also preferable. FIG. 8B shows a multi-chamber infusion container in which the first container and the second container are integrated only by the partition member. However, as shown in FIGS. If it integrates, since a 1st container and a 2nd container will be integrated more firmly, it is preferable.

(使用方法)
本発明の複室輸液容器を使用する際に内容物を混合させる方法は、例えば、仕切部材4を連通させた後、第1容器1を一回押圧すればよい。第1容器1を押圧して内圧を高めることにより、第1容器1の内容物が連通可能となった仕切部材4から第2容器2に流入する。これにより第1容器1及び第2容器2の各弱シール部が剥離して連通し、内容物が混合される。このように仕切部材4を連通させること、第1容器1の内容物の内圧を高めること、この2回の操作手順により混合させることができる。第2容器2内の小室が増えたときにも、この操作手順、回数に変化はない。
なお、仕切部材連通前に第1容器1を押圧して第1容器1内の弱シール部を剥離させてもよい。
(how to use)
The method of mixing the contents when using the multi-chamber infusion container of the present invention may be, for example, by pressing the first container 1 once after the partition member 4 is communicated. By pressing the first container 1 to increase the internal pressure, the contents of the first container 1 flow into the second container 2 from the partition member 4 that can communicate. Thereby, each weak seal part of the 1st container 1 and the 2nd container 2 peels and connects, and the contents are mixed. Thus, it can be made to mix by making the partition member 4 communicate, raising the internal pressure of the contents of the 1st container 1, and these two operation procedures. Even when the number of small chambers in the second container 2 increases, the operation procedure and the number of times do not change.
In addition, you may press the 1st container 1 before a partition member communication, and may peel the weak seal part in the 1st container 1. FIG.

第1容器1の内圧を高めるためには複室輸液容器Yを平面上に載置し上から手で押圧する、あるいは吊り下げた状態で、第1容器1を両側面から握りつぶすなどの方法がある。本発明の複室輸液容器Yは吊下げた状態であっても、両手で仕切部材4の幅方向の中心に親指をあて、屈曲させることにより仕切部材4の連通操作が可能であり、緊急を要する場合などで平面が無い場所であっても確実に容易に迅速に完全混合させることが可能である。   In order to increase the internal pressure of the first container 1, a method of placing the multi-chamber infusion container Y on a flat surface and pressing it manually from above, or squeezing the first container 1 from both sides in a suspended state There is. Even when the multi-chamber infusion container Y of the present invention is in a suspended state, it is possible to communicate the partition member 4 with both hands by placing the thumb at the center of the partition member 4 in the width direction and bending it. Even if it is necessary, even in a place where there is no flat surface, it is possible to carry out complete mixing easily and quickly.

(薬剤入り複室輸液容器の製造方法)
本発明の複室輸液容器に薬剤を充填し、薬剤入り複室輸液容器を製造する方法は特に限定されないが、その1例を図6に示す。
(1)仕切部材を射出成形により製造する。図6の例では仕切部材4として、図4Aに示したタイプで支持部材46の無いものを用いた例である。
(Manufacturing method of drug-containing multi-chamber infusion container)
A method for filling a multi-chamber infusion container of the present invention with a drug and producing a multi-chamber infusion container containing a drug is not particularly limited, but one example is shown in FIG.
(1) The partition member is manufactured by injection molding. In the example of FIG. 6, the partition member 4 is an example using the type shown in FIG. 4A and having no support member 46.

(2)第1容器の製造
1) 可撓性材料として、フィルム61を準備して図6の(2)−1)に示す形状に強シール部62と弱シール部63を形成する。図6の例では筒状フィルムを用いている。
強シール部62の左側面には弱シール部63の上と下の双方に充填口を形成するために強シール部の幅の狭い箇所62aを設けている。
2) 強シール部62に沿って、筒状フィルム61から第1容器形状に切り取る。この形状は上部に開口部64、下部にポート取り付け用の開口部65を有している。
3) ポート7を下部の開口部65に挿入し、液密にシールする。
(2) Production of first container 1) A film 61 is prepared as a flexible material, and a strong seal portion 62 and a weak seal portion 63 are formed in the shape shown in (2) -1) of FIG. In the example of FIG. 6, a tubular film is used.
On the left side surface of the strong seal portion 62, a narrow portion 62a of the strong seal portion is provided in order to form filling ports both above and below the weak seal portion 63.
2) Along the strong seal portion 62, cut from the tubular film 61 into a first container shape. This shape has an opening 64 at the top and an opening 65 for port attachment at the bottom.
3) Insert the port 7 into the lower opening 65 and seal it fluid-tight.

(3)第2容器の製造
1)可撓性材料としてフィルム66を準備する。この可撓性材料は第1容器に用いた可撓性材料と同じでもよく、仕切部材4と溶着可能であれば異なる可撓性材料でもよい。図6の例では筒状フィルムを用いている。
2)第2容器の各小室に分ける位置に弱シール部67を設ける。各弱シール部の両端は剥離防止のため強シール部68を設けておく。
(3) Production of second container 1) A film 66 is prepared as a flexible material. This flexible material may be the same as the flexible material used for the first container, or may be a different flexible material as long as it can be welded to the partition member 4. In the example of FIG. 6, a tubular film is used.
2) A weak seal portion 67 is provided at a position where the second container is divided into the small chambers. Strong seal portions 68 are provided at both ends of each weak seal portion to prevent peeling.

(4)第1容器、第2容器及び仕切部材の一体化
1)仕切部材4における筒部材の中空部の底面側(仕切体が形成された側)を下にして、第1容器の上部開口部64に仕切部材4を挿入し(4)−1)、筒部材の中空部41に支持体69を挿入する(4)−1)−1。
2)ヒートシールによって第1容器1と仕切部材4とを液密に強シールする。
3) 仕切部材4付第1容器1の上部を第2容器開口下部81で覆う。この時、第2容器の弱シール部67下部の強シール部68が第1容器の強シール部5にあたるようにする。
4) 支持体69を第2容器開口上部82から第2容器を上から下へ貫通して、筒部材中空部41に挿入する。
5) 第1容器1と仕切部材4との溶着部分である強シール部5の上に第2容器下部を溶着する。このとき、第2容器の強シール部6は、第1容器の強シール部上に重ねず、第2容器と仕切部材とを直接溶着してもよい。さらに、第2容器の側部も強シールする。
(4) Integration of the first container, the second container, and the partition member 1) The top opening of the first container with the bottom surface side (side on which the partition body is formed) of the hollow portion of the cylindrical member in the partition member 4 facing downward The partition member 4 is inserted into the portion 64 (4) -1), and the support 69 is inserted into the hollow portion 41 of the cylindrical member (4) -1) -1.
2) The first container 1 and the partition member 4 are strongly sealed by heat sealing.
3) The upper part of the first container 1 with the partition member 4 is covered with a second container opening lower part 81. At this time, the strong seal portion 68 below the weak seal portion 67 of the second container is made to hit the strong seal portion 5 of the first container.
4) The support body 69 is inserted from the second container opening upper part 82 through the second container from the top to the bottom, and inserted into the cylindrical member hollow part 41.
5) The lower part of the second container is welded onto the strong seal part 5 which is the welded part between the first container 1 and the partition member 4. At this time, the strong seal portion 6 of the second container may be welded directly to the second container and the partition member without overlapping the strong seal portion of the first container. Furthermore, the side part of the second container is also strongly sealed.

(5)第2容器への薬剤充填
1)第2容器上方の開口部82a、82b、82cから薬剤e、f、gを充填する。
2)薬剤充填後、第2容器2の上部を強シールし、強シール部に吊孔83を設ける。
(5) Drug filling into the second container 1) The drugs e, f and g are filled from the openings 82a, 82b and 82c above the second container.
2) After filling the medicine, the upper part of the second container 2 is strongly sealed, and the suspension hole 83 is provided in the strong seal part.

(6)第1容器への薬剤充填
1)第1容器1左側面(1点鎖線部i)を切断して充填口84を開口させる。
2)開口した充填口84から薬剤l、mを充填する。
3)薬剤充填後、開口した充填口を閉じるように第1容器左側面を強シールする。
(6) Drug filling into the first container 1) The left side surface of the first container 1 (one-dot chain line portion i) is cut to open the filling port 84.
2) The drugs 1 and m are filled from the opened filling port 84.
3) After filling the medicine, the left side surface of the first container is strongly sealed so as to close the opened filling port.

(7)外形のトリミング、加熱滅菌
1)得られた複室輸液容器側面を切断、トリミングする。
2)レトルト殺菌(高温蒸気滅菌)等の加熱滅菌処理を施す。
(7) Trimming of outer shape and heat sterilization 1) Cut and trim the side surface of the obtained multi-chamber infusion container.
2) Perform heat sterilization such as retort sterilization (high-temperature steam sterilization).

薬剤の充填は無菌的な環境下で充填する必要があるが、充填前に洗浄する、無菌環境下での充填など、適宜行えばよい。
また、上述の例では第1容器への充填を側面から行ったが、ポート7から充填してもよい。
The drug needs to be filled in an aseptic environment, but may be appropriately performed such as washing before filling or filling in an aseptic environment.
In the above example, the first container is filled from the side, but may be filled from the port 7.

また、上述の例では、仕切部材4付第1容器1の上部を第2容器開口下部81で覆ってシールして第1容器及び第2容器を一体化させているが、これとは逆に、仕切部材付第2容器を作成した後、第1容器開口上部で覆ってシールして第1容器及び第2容器を一体化してもよい。
また、上述の例では、仕切部材を第1容器に挿入シールした後、第1容器1及び第2容器2を一体化した後に薬剤を充填した例であるが、第2容器2に薬剤を充填した後、第1容器1と一体化させてもよい。この場合には、図4(B)の仕切部材を第2容器2に挿入シール後、薬剤を充填した第2容器2と第1容器1とを連結する。
このように、仕切部材に図4(B)の仕切部材4′を用いれば、図6(4)−1)−1、(4)−4)の工程で用いる支持体69が不要となりシール装置が簡単になる、第2容器への薬剤充填後に第1容器との連結が可能になるなどの利点がある。
In the above example, the upper part of the first container 1 with the partition member 4 is covered and sealed with the second container opening lower part 81 to integrate the first container and the second container. After creating the second container with a partition member, the first container and the second container may be integrated by covering and sealing with the upper opening of the first container.
In the above example, the partition member is inserted and sealed in the first container, and then the first container 1 and the second container 2 are integrated and then the medicine is filled. However, the second container 2 is filled with the medicine. After that, the first container 1 may be integrated. In this case, the partition member shown in FIG. 4B is inserted and sealed in the second container 2, and then the second container 2 filled with the drug and the first container 1 are connected.
As described above, when the partition member 4 ′ of FIG. 4B is used as the partition member, the support 69 used in the steps of FIGS. 6 (4) -1) -1 and (4) -4) becomes unnecessary, and the sealing device. There is an advantage that the connection to the first container becomes possible after the drug is filled in the second container.

シールは、ヒートシール、インパルスシール、超音波シールなどの方法を用いることができる。
弱シール部を形成する方法は、特に限定されるものではないが、例えば、容器の最内面をポリエチレンとポリプロピレンの組成物層等の融点や相溶性の異なる樹脂の組成物からなる層を形成させた可撓性材料を用いて高融点樹脂の温度以下でシールする方法、弱シール部付近を予め電子線などで架橋した可撓性材料を用いてシールする方法、強融着部と低融着部を特定の面積割合で発生させるシールバーを用いてシールする方法及び2枚の可撓性材料の間に易剥離性の樹脂製テープを挟んでシールする方法などが挙げられる。
加熱滅菌の方法としては、慣用の方法をいずれも使用することができ、たとえば、高圧蒸気滅菌、熱水浸漬滅菌、熱水シャワー滅菌、γ線滅菌、電子線滅菌などの方法が挙げられる。
For the sealing, methods such as heat sealing, impulse sealing, and ultrasonic sealing can be used.
The method of forming the weak seal portion is not particularly limited. For example, the innermost surface of the container is formed with a layer made of a resin composition having different melting points and compatibility such as a composition layer of polyethylene and polypropylene. A method of sealing using a flexible material at a temperature lower than the temperature of the high melting point resin, a method of sealing using a flexible material cross-linked with an electron beam or the like in the vicinity of the weak seal portion, and a strong fusion portion and low fusion. Examples include a method of sealing using a seal bar that generates a portion with a specific area ratio, and a method of sealing by sandwiching an easily peelable resin tape between two flexible materials.
Any conventional method can be used as the heat sterilization method, and examples thereof include high-pressure steam sterilization, hot water immersion sterilization, hot water shower sterilization, γ-ray sterilization, and electron beam sterilization.

(薬剤入り輸液容器)
本発明の複室輸液容器Yにおける第1容器1の室に収容される薬剤としては、特に限定されるものではないが、糖、電解質及びアミノ酸などが挙げられ、これらの薬剤を製剤とした糖類製剤、たんぱく質アミノ酸製剤及び血液代用剤などが収容される。
本発明の複室輸液容器Yにおける第2容器2の室に収容される薬剤としては、特に限定されるものではないが、ビタミン類、微量元素、補正用塩化カルシウム、インスリン、抗生物質、抗がん剤、消化性潰瘍剤、肝臓障害用剤、強心剤、鎮痛剤、解熱鎮痛消炎剤、麻酔剤、脂肪乳剤、血圧降下剤、血管拡張剤、ホルモン剤などが挙げられる。これらの薬剤は液体または粉体状の固体として収容される。また、生理食塩水及び蒸留水など溶解液も例示される。
(Medicine infusion container)
Although it does not specifically limit as a chemical | medical agent accommodated in the chamber of the 1st container 1 in the multi-chamber infusion container Y of this invention, Sugar, an electrolyte, an amino acid, etc. are mentioned, Sugars which made these chemical | medical agents a formulation Contains preparations, protein amino acid preparations, blood substitutes, and the like.
The medicine accommodated in the chamber of the second container 2 in the multi-chamber infusion container Y of the present invention is not particularly limited, but vitamins, trace elements, correction calcium chloride, insulin, antibiotics, anti Examples include cancer drugs, peptic ulcer agents, liver damage agents, cardiotonic agents, analgesics, antipyretic analgesics, anti-inflammatory agents, anesthetics, fat emulsions, antihypertensive agents, vasodilators, hormonal agents and the like. These drugs are stored as liquid or powdered solids. Examples of the solution include physiological saline and distilled water.

本発明の複室輸液容器Yは、経中心静脈栄養法に用いられる経中心静脈栄養用キット製剤や経末梢静脈栄養用キット製剤、経腸栄養法に用いられる成分栄養剤などの容器として用いることができる。
例えば、経中心静脈栄養法用の経中心静脈栄養用キット製剤として、開始液や維持液として使用される高カロリー輸液の好ましい態様として、第1容器の室には、糖、電解質及びアミノ酸のいずれか1種以上を含有する薬剤が収容され、第2容器の室には、水溶性ビタミン、脂溶性ビタミン、微量元素のいずれか1種以上を含有する薬剤が収容される。
微量元素は、例えば、銅、鉄、マンガン、亜鉛等の微量金属、ヨウ素などが挙げられる。微量金属は水溶液又は固形薬剤として収容され、水溶性ビタミン、脂溶性ビタミンなどのビタミン類(プロビタミンを含む)は凍結乾燥物(固形薬剤)あるいは水溶液として収容される。
The multi-chamber infusion container Y of the present invention is used as a container for transcentric parenteral nutrition kit preparations, transperipheral parenteral nutrition kit preparations used in transcentral parenteral nutrition, and component nutrients used in enteral nutritional methods. Can do.
For example, as a preferred embodiment of a high-calorie infusion used as a starter liquid or a maintenance liquid as a kit preparation for transcentral parenteral nutrition for transcentral parenteral nutrition, the first container chamber may contain any of sugar, electrolyte, and amino acid. A medicine containing at least one kind is accommodated, and a medicine containing any one or more of water-soluble vitamins, fat-soluble vitamins and trace elements is accommodated in the chamber of the second container.
Examples of the trace element include trace metals such as copper, iron, manganese, and zinc, and iodine. Trace metals are stored as aqueous solutions or solid drugs, and vitamins (including provitamins) such as water-soluble vitamins and fat-soluble vitamins are stored as lyophilized products (solid drugs) or aqueous solutions.

図1〜3で例示した本発明の複室輸液容器Yは、剥離可能な弱シール部で液密に区画された少なくとも2つの室を有する第2容器2及び第1容器1が屈曲して連通する仕切部材により一体され、仕切部材の屈曲連通操作、第1容器の押圧操作の2回の操作で、すべての薬剤を容易に迅速に混合することができる。   The multi-chamber infusion container Y of the present invention illustrated in FIGS. 1 to 3 is configured such that the second container 2 and the first container 1 having at least two chambers partitioned liquid-tightly by a peelable weak seal portion are bent and communicated. All the medicines can be easily and quickly mixed by two operations of the partition member bending communication operation and the first container pressing operation.

従来の、高カロリー輸液を利用した経中心静脈栄養療法では、無菌製剤室での混注作業がしばしば必要であったが、本発明の多室化が容易な複室輸液容器に消化性潰瘍剤や肝臓障害溶剤を注入することにより在宅高カロリー輸液療法用の薬剤入容器とすることが可能となる。   In conventional transcentral parenteral nutrition therapy using high-calorie infusion, mixed injection work in a sterile preparation chamber is often required. By injecting the liver injury solvent, it becomes possible to make a drug container for high-calorie infusion therapy at home.

は、本発明の複室輸液容器の実施態様例を示す図である。These are figures which show the example of an embodiment of the multi-chamber infusion container of this invention. は、第1容器の1実施態様例を示す図である。These are figures which show 1 example of implementation of a 1st container. は、第2容器の実施態様例を示す図である。These are figures which show the example of an embodiment of a 2nd container. は、仕切部材の実施態様例を示す図である。These are figures which show the example of an embodiment of a partition member. は、ポートの実施態様例を示す図である。FIG. 4 is a diagram illustrating an example of implementation of a port. は、薬剤入り複室輸液容器の製造方法の一例を示す図である。These are figures which show an example of the manufacturing method of the multi-chamber infusion container containing a medicine. は、ブロー成形で得た第1容器を用いた実施態様例を示す図である。These are figures which show the example of an embodiment using the 1st container obtained by blow molding. は、仕切部材の屈曲操作を容易にするための工夫がなされた複室輸液容器の実施態様例を示す図である。These are figures which show the example of an embodiment of the multi-chamber infusion container by which the device for making bending | flexion operation of a partition member easy was made | formed.

符号の説明Explanation of symbols

1:第1容器、 2:第2容器、 3、5、6、6′:強シール部、
8、11、12、13、15、16、19、20:弱シール部、
4、4′:仕切部材、 10a:第1の小室、 10b:第2の小室、
10c:第3の小室、 14:第2の強シール部、41:中空部、42:仕切体、
43:筒部材、 44:薄肉部、Y:複室輸液容器


1: first container, 2: second container, 3, 5, 6, 6 ′: strong seal part,
8, 11, 12, 13, 15, 16, 19, 20: weak seal part,
4, 4 ': partition member, 10a: first chamber, 10b: second chamber,
10c: 3rd chamber, 14: 2nd strong seal part, 41: Hollow part, 42: Partition body,
43: cylinder member, 44: thin part, Y: multi-chamber infusion container


Claims (13)

薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器は剥離可能な弱シール部で区画された2つ以上の小室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室とを具備してなり、第1容器を下側、第2容器を上側に配置したとき、前記第2容器内の弱シール部の少なくとも一つは前記第2容器の下端の強シール部と前記第2容器の上端または側部の強シール部との間を仕切ってなるものであることを特徴とする複室輸液容器。
In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member, and the first container and A multi-chamber infusion container partitioned between second containers,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a partition means capable of communication, and the second container has two or more small chambers partitioned by a peelable weak seal portion, The chamber of the second container includes a first chamber adjacent to the partition member and a second chamber adjacent to the first chamber via the weak seal portion, and the first container is placed under the first container. When the second container is disposed on the side, at least one of the weak seal portions in the second container is a strong seal portion at the lower end of the second container and a strong seal portion at the upper end or the side portion of the second container. A multi-chamber infusion container characterized by being partitioned between the two.
薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器は剥離可能な弱シール部で区画された2つ以上の小室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する複数の第2の小室とを具備してなり、第1容器を下側、第2容器を上側に配置したとき、前記弱シール部は前記第2容器の両側部を結ぶ様に形成され、前記弱シール部と第2容器上端の強シール部の間に形成された複数の第2の小室間が、前記上端の強シール部の一部から延びる第2の強シール部で仕切られているものであることを特徴とする複室輸液容器。
In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member, and the first container and A multi-chamber infusion container partitioned between second containers,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a partition means capable of communication, and the second container has two or more small chambers partitioned by a peelable weak seal portion, The small chamber of the second container includes a first small chamber adjacent to the partition member and a plurality of second small chambers adjacent to the first small chamber via the weak seal portion. When the second container is disposed on the lower side, the weak seal portion is formed so as to connect both side portions of the second container, and is formed between the weak seal portion and the strong seal portion at the upper end of the second container. A plurality of second small chambers partitioned by a second strong seal portion extending from a part of the strong seal portion at the upper end.
薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器は剥離可能な弱シール部で区画された2つ以上の小室を有し、
前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室と、前記弱シール部を介して前記第2の小室に隣接する第3の小室とを具備してなることを特徴とする複室輸液容器。
In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member, and the first container and A multi-chamber infusion container partitioned between second containers,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a partitioning means capable of communication, and the second container has two or more small chambers partitioned by a peelable weak seal portion,
The chambers of the second container include a first chamber adjacent to the partition member, a second chamber adjacent to the first chamber via the weak seal portion, and the first chamber via the weak seal portion. A multi-chamber infusion container comprising a third chamber adjacent to the two chambers.
第1容器を下側、第2容器を上側に配置したとき、仕切部材を挟んで設けられた第2容器下端の2つの強シール部の仕切部材に面する両端を結ぶように弱シール部が設けられ、該弱シール部と2つの下端強シール部、仕切部材とで囲まれた第1の小室が形成され、両側の下端強シール部のそれぞれから前記第2容器の上端強シール部を結ぶように弱シール部が設けられ、これらの弱シール部と前記上端強シール部に囲まれて第2の小室が形成されてなるものであることを特徴とする請求項3記載の複室輸液容器。   When the first container is disposed on the lower side and the second container is disposed on the upper side, the weak seal portion is connected so as to connect both ends facing the partition members of the two strong seal portions at the lower end of the second container provided across the partition member. A first small chamber is formed, surrounded by the weak seal portion, the two lower end strong seal portions, and the partition member, and connects the upper end strong seal portion of the second container from each of the lower end strong seal portions on both sides. The multi-chamber infusion container according to claim 3, wherein a weak seal portion is provided, and a second small chamber is formed surrounded by the weak seal portion and the upper end strong seal portion. . 第1容器を下側、第2容器を上側に配置したとき、前記第2容器の両側部を結ぶ様に2本の弱シール部が設けられ、その弱シール部の少なくとも一つが、その一部に角部を有する屈曲部を有することを特徴とする請求項3記載の複室輸液容器。   When the first container is disposed on the lower side and the second container is disposed on the upper side, two weak seal portions are provided so as to connect both side portions of the second container, and at least one of the weak seal portions is a part thereof. 4. The multi-chamber infusion container according to claim 3, further comprising a bent portion having a corner portion. 薬剤を収納する室を有する第1容器及び第2容器が一体化した複室輸液容器において、可撓性材料からなる第1容器及び第2容器が仕切部材により一体化されると共に第1容器及び第2容器の間を仕切られた複室輸液容器であって、
前記仕切部材は、隣接する2つの容器を連通可能に接続する筒部材、隣接する2つの容器を液密に仕切る仕切体並びに前記仕切体及び前記筒部材の連結部には破断可能な薄肉部を有し、
前記第1容器は、連通可能な仕切手段で区画された2つ以上の大室を有し、前記第2容器の小室は、前記仕切部材に隣接する第1の小室と、前記弱シール部を介して前記第1の小室に隣接する第2の小室とを具備してなり、第1容器を下側、第2容器を上側に配置したとき、前記第2容器は仕切部材と、該仕切部材の両側部から水平に延びる強シール部から構成される下端と該下端の両端から伸びる上に凸の弧状強シール部により外周が形成され、前記第2容器内の弱シール部は前記第2容器の下端の強シール部と弧状強シール部との間を仕切ってなるものであることを特徴とする複室輸液容器。
In a multi-chamber infusion container in which a first container having a chamber for storing a medicine and a second container are integrated, the first container and the second container made of a flexible material are integrated by a partition member, and the first container and A multi-chamber infusion container partitioned between second containers,
The partition member includes a cylindrical member that connects two adjacent containers so as to communicate with each other, a partition body that partitions the two adjacent containers in a liquid-tight manner, and a ruptureable thin portion at a connecting portion between the partition body and the cylindrical member. Have
The first container has two or more large chambers partitioned by a communicating partition means, and the small chamber of the second container includes a first small chamber adjacent to the partition member and the weak seal portion. A second chamber adjacent to the first chamber, and when the first container is disposed on the lower side and the second container is disposed on the upper side, the second container has a partition member and the partition member. The outer periphery is formed by a lower end composed of a strong seal portion extending horizontally from both sides of the upper end and an arc-shaped strong seal portion extending from both ends of the lower end, and the weak seal portion in the second container is the second container. A multi-chamber infusion container characterized in that it is formed by partitioning a strong seal portion at the lower end of an arc and a strong arc-shaped seal portion.
第1容器及び第2容器が仕切部材並びに強シール部により一体化され、該強シール部の少なくとも一方に複室輸液容器の表から裏へ指を挿入できる開口部を設けてなることを特徴とする請求項1〜6のいずれか1項に記載の複室輸液容器。   The first container and the second container are integrated by a partition member and a strong seal part, and at least one of the strong seal parts is provided with an opening through which a finger can be inserted from the front to the back of the multi-chamber infusion container. The multi-chamber infusion container according to any one of claims 1 to 6. 前記薄肉部を破断させた後に、第1容器を一回押圧するだけで、第1容器及び第2容器内の全ての室が連通可能であることを特徴とする請求項1〜7のいずれか1項に記載の複室輸液容器。   Any one of the first container and the second container can communicate with each other only by pressing the first container once after the thin-walled portion is broken. The multi-chamber infusion container according to Item 1. 第2容器の室の少なくとも1室が遮光部材で遮光されていることを特徴とする請求項1〜8のいずれか1項に記載の複室輸液容器。   The multi-chamber infusion container according to any one of claims 1 to 8, wherein at least one of the chambers of the second container is shielded from light by a light shielding member. 第2容器の最内層が脂溶性ビタミンに対して低吸着性の材料からなることを特徴とする請求項1〜9のいずれか1項に記載の複室輸液容器。   10. The multi-chamber infusion container according to claim 1, wherein the innermost layer of the second container is made of a material having a low adsorptivity to the fat-soluble vitamin. 第2容器の全ての弱シール部が仕切部材に隣接する第1の小室の周縁の弱シール部であることを特徴とする請求項1〜10のいずれか1項に記載の複室輸液容器。   11. The multi-chamber infusion container according to claim 1, wherein all weak seal portions of the second container are weak seal portions at the periphery of the first small chamber adjacent to the partition member. 第2容器の少なくとも1つの室が注入口を有する予備室であることを特徴とする請求項1〜11のいずれか1項に記載の複室輸液容器。   The multi-chamber infusion container according to any one of claims 1 to 11, wherein at least one chamber of the second container is a preliminary chamber having an injection port. 請求項1〜12のいずれか1項に記載の複室輸液容器であって、第1容器の室に糖、電解質及びアミノ酸のいずれか1種以上を含有する薬剤が収容され、第2容器の室に水溶性ビタミン、脂溶性ビタミン及び微量元素のいずれか1種以上を含有する薬剤が収容されることを特徴とする薬剤入り複室輸液容器。

The multi-chamber infusion container according to any one of claims 1 to 12, wherein a medicine containing any one or more of sugar, electrolyte and amino acid is accommodated in the chamber of the first container, and the second container A drug-containing multi-chamber infusion container characterized by containing a drug containing at least one of water-soluble vitamins, fat-soluble vitamins and trace elements in a chamber.

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KR200450674Y1 (en) 2008-07-28 2010-10-21 주식회사 메디파마플랜 Non-PVC medical container with multiple chambers
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KR200450674Y1 (en) 2008-07-28 2010-10-21 주식회사 메디파마플랜 Non-PVC medical container with multiple chambers
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