JP2008029529A - Medical multi-chamber container - Google Patents

Medical multi-chamber container Download PDF

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JP2008029529A
JP2008029529A JP2006205246A JP2006205246A JP2008029529A JP 2008029529 A JP2008029529 A JP 2008029529A JP 2006205246 A JP2006205246 A JP 2006205246A JP 2006205246 A JP2006205246 A JP 2006205246A JP 2008029529 A JP2008029529 A JP 2008029529A
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chamber
container
drug
covering member
port
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JP4973052B2 (en
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Minoru Honda
稔 本田
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Nipro Corp
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Nipro Corp
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical multi-chamber container capable of attaching a cover member thereto despite of the shapes of a container body and a port and surely detaching the cover member from the port or a hanging hole simultaneously with the communication of the respective chambers. <P>SOLUTION: This medical multi-chamber container containing medicines includes a flexible container body liquid-tightly partitioned into an upper medicine chamber and a lower medicine chamber by a peelable weak seal part, the hanging hole provided in the upper part of the container body, the port provided in the lower part of the container body to communicate with the lower medicine chamber and having a penetration hole, and the bag-shaped cover member contracting and covering the port or the hanging hole across the outer circumference of its adjacent medicine chamber; and, when the medicine chamber non-covered with the cover member is pushed to peel off the weak seal part and communicate the respective medicine chambers, the cover member is broken and is removable from the container body. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

本発明は、医療用複室容器に関する。詳しくは、未連通状態で使用不可能な医療用複室容器に関する。   The present invention relates to a medical multi-chamber container. Specifically, the present invention relates to a medical multi-chamber container that cannot be used in an unconnected state.

予め混合した状態で保管しておくと変質などによって保存性が悪くなる薬剤や薬液がある。これらの薬剤や薬液は個別に保管され、使用直前に無菌混合によって混合され使用される。保管時には薬剤や薬液を個々に保管し、使用時にはこれらの薬剤や薬液を無菌混合するために医療用複室容器が用いられている。   There are drugs and chemicals that have poor storability due to alteration when stored in a premixed state. These drugs and drug solutions are stored separately and mixed and used by aseptic mixing immediately before use. A medical multi-chamber container is used to store drugs and chemical solutions individually during storage and to aseptically mix these drugs and chemical solutions during use.

これは、容易に剥離可能な弱シール部によって区画される複数の室内に複数の薬剤及び薬液を別々に保存しておき、薬剤投与の直前に容器を手で押圧するなどして弱シール部を剥離させ、複数の室を連通させて内容物を無菌状態で混合あるいは溶解させるというものである。   This is because a plurality of medicines and chemical solutions are stored separately in a plurality of chambers partitioned by weak seal parts that can be easily peeled off, and the weak seal parts are removed by pressing the container by hand immediately before drug administration. The contents are exfoliated and the contents are mixed or dissolved under aseptic conditions by communicating with a plurality of chambers.

しかし、従来の医療用複室容器は、複数の室が連通したかどうかを見分ける方法はなく、目視により見分けることが一般的である。そのため医療用複室容器に封入されている薬剤を連通しないまま患者に投与してしまうといったミスが報告されている。   However, the conventional medical multi-chamber container does not have a method of distinguishing whether or not a plurality of chambers communicate with each other, and is generally distinguished visually. For this reason, it has been reported that a drug enclosed in a medical multi-chamber container is administered to a patient without communication.

このような未連通状態での患者への複室容器からの薬剤投与を回避するために、未連通状態で薬剤を投与しないような機構が提案されている。例えば、ポートもしくは吊り下げ孔に隣接する薬剤室に液剤を封入し、液剤を充填した薬剤室ごと、隣接するポートまたは吊り下げ孔を袋状の部材で被覆したものがあり、これを使用する際には、袋状の部材内に存在する液剤の充填された薬剤室から、液剤を他方の薬剤室へ移動させることにより、袋状の部材を抜き取ることが可能な構造が提案されている(特許文献1)。   In order to avoid the administration of the drug from the multi-chamber container to the patient in such a disconnected state, a mechanism that does not administer the drug in the disconnected state has been proposed. For example, when a drug is sealed in a drug chamber adjacent to a port or suspension hole and the drug chamber filled with the liquid is coated, the adjacent port or suspension hole is covered with a bag-shaped member. Has proposed a structure in which a bag-like member can be removed from a drug chamber filled with a liquid agent present in a bag-like member by moving the liquid agent to the other drug chamber (patent) Reference 1).

また、複室容器のポート部を硬質の被覆部材を係合させることによって装着し、ポートが連通していない側の薬剤室を押圧して連通し、ポートが連通している側の薬剤室を膨張させることによって、被覆部材を破壊する構造が提案されている(特許文献2)。 In addition, the port portion of the multi-chamber container is attached by engaging a hard covering member, and the drug chamber on the side where the port is not communicated is pressed and communicated, and the drug chamber on the side where the port is communicated A structure that destroys a covering member by expanding is proposed (Patent Document 2).

特開2005−211558号JP-A-2005-212558 特開2005−305136号JP-A-2005-305136

しかし、特許文献1のような、熱収縮フィルムより形成された袋状の部材で覆い、収縮させて装着し、引き抜く形態の場合には、必要以上に収縮しすぎてしまうことによって、複室容器に密着しすぎてしまい、各薬剤室の連通後であっても複室容器から脱離できなくなったり、袋全体が収縮するためにポートの形状に沿うように密着するように包み込んでしまい、開封できなくなったりといった問題が生じる。また、特許文献2のような、被覆部材に硬質材料を用いる場合には、液剤が封入されている薬剤室に硬質の被覆部材を装着させる際に圧力がかかってしまい連通してしまう等の不具合が生じたり、また、装着に際し、ポートや容器本体等の形状に依存するため、形状が異なるものには使用できない。そこで、未連通使用防止部材の複室容器への固定方法に特別な構造を必要とせず、連通と同時に確実に取り外し可能となる構造を持つ、未連通での患者への薬剤投与が回避可能な構造が必要である。   However, in the case of a configuration in which a bag-like member formed of a heat-shrink film, such as Patent Document 1, is covered, contracted, and pulled out, it is contracted more than necessary, resulting in a multi-chamber container. Even after the communication of each drug room, it cannot be detached from the multi-chamber container, or the bag is shrunk so that it is wrapped in close contact with the shape of the port and opened. Problems such as being unable to do so occur. In addition, when a hard material is used for the covering member as in Patent Document 2, when the hard covering member is attached to the drug chamber in which the liquid agent is sealed, pressure is applied and communication occurs. In addition, since it depends on the shape of the port, the container main body, etc. when mounting, it cannot be used for different shapes. Therefore, there is no need for a special structure for fixing the non-communication use prevention member to the multi-chamber container, and it is possible to avoid drug administration to the patient without communication, having a structure that can be surely removed simultaneously with communication. A structure is needed.

本発明の目的は、容器本体やポート等の形状によらず被覆部材を取り付け可能であり、各室が連通すると同時に確実に被覆部材をポートまたは吊り下げ孔より脱離可能である医療用複室容器を提供することにある。   It is an object of the present invention to attach a covering member regardless of the shape of a container main body, a port or the like, and a medical multiple chamber in which each chamber communicates with each other and the covering member can be reliably detached from a port or a suspension hole. To provide a container.

そこで、本発明者らは、
(1)薬剤入りの医療用複室容器であって、剥離可能な弱シール部によって上部薬剤室と下部薬剤室とに液密に区画され、少なくとも前記上部薬剤室には薬液が封入されている可撓性の容器本体と、前記容器本体の上部に設けられた吊り下げ孔と、前記容器本体の下部に、前記下部薬剤室と連通するように設けられた刺通口を有するポートと、前記下部薬剤室外周に係るように前記ポートごと収縮被覆する袋状の被覆部材とを含み、前記被覆部材は、前記上部薬剤室を押圧して前記弱シール部を剥離し、各々の薬剤室を連通させると破壊され、前記容器本体より取り除くことが可能となることを特徴とする医療用複室容器。
(2)前記被覆部材の下部であって、前記容器本体及び前記ポートに係らない領域に把持部を有する(1)に記載の医療用複室容器。
(3)前記被覆部材には破壊されやすいように被覆部材上端から下方に向かって破線状の切り込みを有する、(1)または(2)に記載の医療用複室容器。
(4)薬剤入りの医療用複室容器であって、 剥離可能な弱シール部によって上部薬剤室と下部薬剤室とに液密に区画され、少なくとも前記下部薬剤室には薬液が封入されている可撓性の容器本体と、前記容器本体の上部に設けられた吊り下げ孔と、前記容器本体の下部に、前記下部薬剤室と連通するように設けられた刺通口を有するポートと、上部薬剤室の外周に係るように前記吊り下げ孔ごと収縮被覆する被覆部材とを含み、前記被覆部材は、前記下部薬剤室を押圧して前記弱シール部を剥離し、各々の薬剤室を連通させると破壊され、前記容器本体より取り除くことが可能となることを特徴とする医療用複室容器。
(5)前記被覆部材の上部であって、前記容器本体に係らない領域に把持部を有する、(4)に記載の医療用複室容器。
(6)前記被覆部材には破壊されやすいように被覆部材下端から上方に向かって破線状の切り込みを有する、(4)または(5)に記載の医療用複室容器。
(7)前記被覆部材の少なくとも一部がシュリンクフィルムで形成されてなる、(1)から(6)のいずれかに記載の医療用複室容器。
(8)前記刺通口に硬質部材が装着されてなる、(1)から(7)のいずれかに記載の医療用複室容器。
を用いることにより、被覆部材を収縮させることで装着させるため、容器本体やポートなどの形状に依存せず、装着させることが可能である。また、被覆していない側の薬剤室を押圧し連通することによって、被覆部材が破壊されるため、被覆部材を容器本体に装着する際に収縮しすぎた場合であっても、被覆部材が容器本体より分離が不可能となってしまうことはない。このように、複室容器の各室が未連通状態ではポートまたは吊り下げ孔を被覆するよう設けられており、各室が連通することによって被覆部材によって被覆されていない側の薬剤室に封入された薬剤が移動し、被覆されている側の薬剤室の厚みが増大することによって破壊され、被覆部材が脱離可能となる構造となっているため、連通構造と被覆部材を脱離する構造がリンクしているため、患者への未調製の薬剤を投与する危険を回避するとともに、複室容器の各薬剤室が連通した際には、速やかに使用可能であることを見出し本願発明に至った。
Therefore, the present inventors
(1) A medical multi-chamber container containing a medicine, which is liquid-tightly divided into an upper medicine chamber and a lower medicine chamber by a peelable weak seal portion, and at least the upper medicine chamber is filled with a medicine solution A flexible container body, a suspension hole provided in an upper part of the container body, a port having a piercing port provided in a lower part of the container body so as to communicate with the lower drug chamber, A bag-shaped covering member that shrinks and covers the entire port so as to relate to the outer periphery of the lower drug chamber, the cover member pressing the upper drug chamber to peel off the weak seal portion, and communicating each drug chamber A medical multi-chamber container which is destroyed when removed and can be removed from the container body.
(2) The medical multi-chamber container according to (1), which has a grip portion in a region below the covering member and not related to the container main body and the port.
(3) The medical multi-chamber container according to (1) or (2), wherein the covering member has a broken line-like notch from the upper end of the covering member so as to be easily broken.
(4) A medical multi-chamber container containing a medicine, which is liquid-tightly divided into an upper medicine chamber and a lower medicine chamber by a peelable weak seal portion, and at least the lower medicine chamber is filled with a medicine solution A flexible container body, a suspension hole provided in the upper part of the container body, a port having a piercing port provided in the lower part of the container body so as to communicate with the lower drug chamber, and an upper part A covering member that shrinks and coats the entire suspension hole so as to relate to the outer periphery of the drug chamber, and the cover member presses the lower drug chamber to peel off the weak seal portion, thereby communicating each drug chamber. A medical multi-chamber container that is broken and can be removed from the container body.
(5) The medical multi-chamber container according to (4), which has a grip portion in an area which is an upper part of the covering member and is not related to the container body.
(6) The medical multi-chamber container according to (4) or (5), wherein the covering member has a broken line-like cut from the lower end of the covering member so as to be easily broken.
(7) The medical multi-chamber container according to any one of (1) to (6), wherein at least a part of the covering member is formed of a shrink film.
(8) The medical multi-chamber container according to any one of (1) to (7), wherein a hard member is attached to the piercing opening.
By using this, the covering member is attached by being contracted, so that it is possible to attach it without depending on the shape of the container body or the port. In addition, since the covering member is destroyed by pressing and communicating with the uncoated medicine chamber, the covering member is used in the container even if the covering member contracts too much when the container member is attached to the container body. Separation from the main body is never impossible. As described above, each chamber of the multi-chamber container is provided so as to cover the port or the hanging hole in a non-communication state, and is sealed in the drug chamber on the side not covered by the covering member by the communication of each chamber. The structure is such that the communication member and the covering member can be detached because the covering member can be detached because the medicine is moved and destroyed by increasing the thickness of the medicine chamber on the coated side. Because it is linked, the risk of administering an unprepared drug to a patient is avoided, and when each drug chamber of a multi-chamber container communicates, it has been found that it can be used quickly, and the present invention has been achieved. .

本発明の医療用複室容器は、薬剤容器の外周に取り付ける収縮装着可能な被覆部材が設けられているため、薬剤容器の形状に依存せず容易に医療用複室容器に取り付け可能であり、各薬剤室が連通すると同時に被覆部材が破壊されるため、外れなくなるといったおそれもない。また、未連通の状態ではポートの刺通口が被覆されているので、未連通のままの調整されていない薬剤を誤って患者に投与することがないため医療に好適に用いることができる。   The medical multi-chamber container of the present invention is provided with a shrinkable and wearable covering member that is attached to the outer periphery of the drug container, and can be easily attached to the medical multi-chamber container without depending on the shape of the drug container, Since the covering members are destroyed at the same time as the respective drug chambers communicate with each other, there is no possibility that they will not come off. In addition, since the port piercing port is covered in a non-communication state, an unadjusted medicine that remains uncommitted is not erroneously administered to a patient, and thus can be suitably used for medical treatment.

以下、図を用いて本発明の医療用複室容器を説明する。しかし、本願発明は、これら図面に記載した実施態様例に限定されるものではない。   Hereinafter, the medical multi-chamber container of the present invention will be described with reference to the drawings. However, the present invention is not limited to the exemplary embodiments described in these drawings.

図1は、本発明の医療用複室容器のポートを被覆したタイプの一実施態様例の図である。図2は、本発明の医療用複室容器の吊り下げ孔を被覆したタイプの一実施態様例の図である。図3は、本発明の医療用複室容器の被覆部材に把持部を設けたタイプの一実施態様例の図である。図4は本発明の医療用複室容器のポート刺通口に硬質部材を設けた図である。図5本発明の医療用複室容器の使用状態の図である。   FIG. 1 is a view of an embodiment of a type in which a port of a medical multi-chamber container of the present invention is covered. FIG. 2 is a diagram of an embodiment of the type in which the suspension hole of the medical multi-chamber container of the present invention is covered. FIG. 3 is a diagram of an embodiment of a type in which a grip portion is provided on the covering member of the medical multi-chamber container of the present invention. FIG. 4 is a view in which a hard member is provided at the port piercing port of the medical multi-chamber container of the present invention. 5 is a diagram of the use state of the medical multi-chamber container of the present invention.

図1は、下部薬剤室1と上部薬剤室2とからなる複室の容器本体Aと、ポート3と未連通使用防止部材4とを含む医療用複室容器である。容器本体Aは、筒状のフィルムから形成された袋状の下部薬剤室1と上部薬剤室2とからなり、弱シール部5によって下部薬剤室1と上部薬剤室2とが液密に区画されている可撓性の複室容器である。下部薬剤室1及び上部薬剤室2には液剤が封入されている。容器本体Aの上部には、容器吊り下げ手段である吊り下げ孔6が設けられ、吊り下げ孔6と対称に位置する容器本体Aの下部には、下部薬剤室1と連通する、下端を刺通口であるゴム栓体31によって閉鎖されたポート3が設けられている。被覆部材4として、下側が閉じられた袋状の部材が、ポート3から容器本体Aの下部薬剤室1に係るように収縮して締め付けられることによって被覆し、被覆部材4の上端から下方に向けて破線状の切り込み41が形成されている。   FIG. 1 is a medical multi-chamber container including a multi-chamber container body A composed of a lower drug chamber 1 and an upper drug chamber 2, a port 3 and a non-communication use preventing member 4. The container body A is composed of a bag-like lower drug chamber 1 and an upper drug chamber 2 formed from a cylindrical film, and the lower drug chamber 1 and the upper drug chamber 2 are partitioned liquid-tightly by a weak seal portion 5. It is a flexible multi-chamber container. The lower drug chamber 1 and the upper drug chamber 2 are filled with a liquid agent. A suspending hole 6 as a container suspending means is provided in the upper part of the container main body A, and the lower end of the container main body A located symmetrically with the suspending hole 6 is pierced at the lower end that communicates with the lower drug chamber 1. A port 3 is provided that is closed by a rubber plug 31 that is a passage. As the covering member 4, a bag-like member whose lower side is closed is covered by being contracted and tightened from the port 3 so as to be related to the lower drug chamber 1 of the container body A, and directed downward from the upper end of the covering member 4. A broken line-shaped cut 41 is formed.

上部薬剤室2を押圧することによって弱シール部5が剥離し、下部薬剤室1と上部薬剤室2とが連通し、初期状態にて上部薬剤室2内に封入されていた液剤が下部薬剤室1へ流れ込む。液剤が移動した下部薬剤室1は体積が膨張する。こうして下部薬剤室1の厚みが増大することによって、下部薬剤室1に収縮して取り付けられている被覆部材4に形成された破線状の切り込み41が千切れて分断されることによって、被覆部材4の締め付けが実質的に解消されるため、被覆部材4が容器本体Aより脱離することが可能となる構造となっている。このように、未連通使用防止部材4は下部薬剤室1と上部薬剤室2とが連通し、上部薬剤室2に封入されていた液剤が、下部薬剤室1に流入することにより下部薬剤室1が膨張するため、被覆部材4が破壊されるため、分離することが可能となる。また、被覆部材4を容器本体Aに装着させる際に収縮させすぎたとしても、被覆部材4が破壊されるので、容器本体Aより分離不能となってしまうといったこともない。即ち下部薬剤室1が膨張することなしに未連通使用防止部材4は外れず、下部薬剤室1と上部薬剤室2とが連通することによって脱離可能となるため容器本体Aが使用可能となる。従って、ポート3のゴム栓体31は、未連通の状態では未連通使用防止部材4が被覆していることによって出現しないので、未連通の状態では輸液具と連通させることを防ぐことができる。なお、下部薬剤室1を押圧し連通した場合においても、その後、上部薬剤室2を押圧すれば、薬液は下部薬剤室1に移動するため、被覆部材4を破壊し容器本体Aより脱離させることは可能である。   When the upper drug chamber 2 is pressed, the weak seal portion 5 is peeled off, the lower drug chamber 1 and the upper drug chamber 2 communicate with each other, and the liquid drug sealed in the upper drug chamber 2 in the initial state is the lower drug chamber. Flow into 1. The volume of the lower drug chamber 1 to which the liquid agent has moved expands. By increasing the thickness of the lower drug chamber 1 in this way, the broken line-shaped cut 41 formed in the cover member 4 contracted and attached to the lower drug chamber 1 is cut into pieces and divided, thereby covering the member 4. Therefore, the covering member 4 can be detached from the container body A. Thus, the non-communication use preventing member 4 communicates with the lower drug chamber 1 and the upper drug chamber 2, and the liquid drug sealed in the upper drug chamber 2 flows into the lower drug chamber 1, whereby the lower drug chamber 1. Since the swell expands, the covering member 4 is destroyed and can be separated. Further, even if the covering member 4 is contracted excessively when being attached to the container main body A, the covering member 4 is destroyed, so that the container main body A cannot be separated. That is, the non-communication use preventing member 4 does not come off without the lower drug chamber 1 expanding, and the container main body A can be used because the lower drug chamber 1 and the upper drug chamber 2 communicate with each other and can be detached. . Therefore, since the rubber plug 31 of the port 3 does not appear when the non-communication use preventing member 4 is covered in the non-communication state, it can be prevented from communicating with the infusion device in the non-communication state. Even when the lower drug chamber 1 is pressed and communicated, if the upper drug chamber 2 is pressed thereafter, the drug solution moves to the lower drug chamber 1, so that the covering member 4 is broken and detached from the container body A. It is possible.

図2は、吊り下げ孔を塞ぐことで未連通時の使用を妨害するものである。容器本体Aの上部には、容器吊り下げ手段である吊り下げ孔6が設けられ、吊り下げ孔6と対称に位置する容器本体Aの下部には、下部薬剤室1と連通する、下端を刺通口であるゴム栓体31によって閉鎖されたポート3が設けられている。被覆部材4として、上側が閉じられた袋状又はバンド状の部材が、吊り下げ孔6を塞ぎ、容器本体Aの上部薬剤室1に係るように収縮して被覆し、被覆部材4の下端から上方に向けて破線状の切り込みが形成されている。   FIG. 2 blocks use when not in communication by closing the suspension hole. A suspending hole 6 as a container suspending means is provided in the upper part of the container main body A, and the lower end of the container main body A located symmetrically with the suspending hole 6 is pierced at the lower end that communicates with the lower drug chamber 1. A port 3 is provided that is closed by a rubber plug 31 that is a passage. As the covering member 4, a bag-like or band-like member whose upper side is closed closes the suspension hole 6, contracts and covers the upper drug chamber 1 of the container body A, and starts from the lower end of the covering member 4. A broken line-shaped cut is formed upward.

吊り下げ孔を被覆部材で被覆する場合には、下部薬剤室1を押圧することによって弱シール部5が剥離し、下部薬剤室1と上部薬剤室2とが連通し、初期状態にて下部薬剤室1内に封入されていた液剤が下部薬剤室1へ流れ込む。液剤が移動した上部薬剤室2は体積が膨張する。こうして上部薬剤室2の厚みが増大することによって、上部薬剤室2に収縮して取り付けられている被覆部材4に形成された破線状の切り込み41が千切れて分断されることによって、被覆部材4の締め付けが実質的に解消されるため、被覆部材4が容器本体Aより脱離することが可能となる構造となっている。   When the suspension hole is covered with a covering member, the weak seal 5 is peeled off by pressing the lower drug chamber 1, and the lower drug chamber 1 and the upper drug chamber 2 communicate with each other. The liquid agent sealed in the chamber 1 flows into the lower drug chamber 1. The volume of the upper drug chamber 2 to which the liquid agent has moved expands. By increasing the thickness of the upper drug chamber 2 in this way, the broken line-shaped cut 41 formed in the cover member 4 contracted and attached to the upper drug chamber 2 is cut off and divided, thereby covering the member 4. Therefore, the covering member 4 can be detached from the container body A.

薬剤室の材質は、薬剤が安定的に保存可能であれば材質は特に限定されるものではなく、通常、薬剤バッグに用いられる合成樹脂製フィルムで形成される。薬剤が粉末である場合には、薬剤を安定に保存可能であって、ガス・水分遮断性を有し、バッグ強度に優れるものが好ましく、フィルムを袋状にしたときに薬剤と接する最内層が薬剤を安定的に保存可能であるポリエチレン及び環状ポリオレフィン、中間層が水分及びガスを遮断にし,印刷強度に優れる蒸着ポリエチレンテレフタレート、外界側となる最外層が製袋性に優れたポリエチレン又はポリエチレンテレフタレートで形成される積層フィルムを用いることが特に好ましい。このようにフィルムを積層することによって、合成樹脂を透過しようとする水分やガスを遮断することが可能である。また、薬剤が液体である場合には、低温衝撃に強く柔軟性に優れるポリエチレンを用いることが好ましい。   The material of the drug chamber is not particularly limited as long as the drug can be stably stored, and is usually formed of a synthetic resin film used for a drug bag. When the drug is a powder, it is preferable that the drug can be stably stored, has gas / moisture barrier properties, and has excellent bag strength, and has an innermost layer that comes into contact with the drug when the film is formed into a bag shape. Polyethylene and cyclic polyolefin that can stably store chemicals, vapor-deposited polyethylene terephthalate with an intermediate layer that blocks moisture and gas, and excellent printing strength, and the outermost layer on the outside is polyethylene or polyethylene terephthalate with excellent bag-making properties. It is particularly preferable to use a laminated film to be formed. By laminating films in this way, it is possible to block moisture and gas that are going to permeate the synthetic resin. When the drug is a liquid, it is preferable to use polyethylene that is resistant to low temperature impact and excellent in flexibility.

図1及び図2に例示された容器本体Aは、筒状のフィルムより複室に区画・形成されているが、上部薬剤室と下部薬剤室とでフィルムの積層素材を換える必要がある場合には、第一の薬剤室と第二の薬剤室とを別々に製造して弱シール部により連結させて容器本体としてもよく、また、必要であれば、フロントシートとリアシートとに分割して形成したフィルムを貼り合わせて薬剤室を形成してもよい。ここで、複室容器に封入される薬剤は、被覆部材に被覆されない側の薬剤室に液剤が封入してあればよく、被覆されない側の薬剤室に封入される薬剤については、液状や粉末状等、物質状態は特に限定されない。   The container body A illustrated in FIG. 1 and FIG. 2 is divided and formed into multiple chambers from a cylindrical film, but when it is necessary to change the laminated material of the film between the upper drug chamber and the lower drug chamber The first drug chamber and the second drug chamber may be manufactured separately and connected by a weak seal part to form a container body. If necessary, the container body is divided into a front seat and a rear seat. You may form the chemical | medical chamber by bonding together the film which carried out. Here, the drug sealed in the multi-chamber container may be a liquid or powdered form for the drug sealed in the drug chamber on the side not covered by the liquid drug in the drug chamber on the side not covered by the covering member. The material state is not particularly limited.

薬剤及び薬液に、光に晒すと変質・劣化してしまうものを用いる場合、薬剤室を形成するフィルムに遮光性を有するものを積層する。通常、薬剤室の片面を、アルミ箔層を加えた積層フィルムで形成し、もう一方の面を、アルミ箔層を加えない積層フィルムで形成した薬剤室を用い、アルミ箔層を加えない積層フィルム側に、剥離可能なアルミとポリエチレンテレフタレートから形成されるカバーシートを被覆させる。これは、両面アルミ箔層を加えることによって封入されている薬剤状態が目視できなくなり、変質に気づかないまま使用してしまうということを避けるためである。   When using chemicals and chemicals that deteriorate or deteriorate when exposed to light, a film having a light shielding property is laminated on the film forming the chemical chamber. Normally, one side of the drug room is formed with a laminated film with an aluminum foil layer added, and the other side is formed with a laminated film without an aluminum foil layer, and the laminated film with no aluminum foil layer added. On the side, a cover sheet made of peelable aluminum and polyethylene terephthalate is coated. This is in order to avoid using the double-sided aluminum foil layer without observing the sealed drug state and not knowing the alteration.

弱シール部5は、各々の薬剤室が液体密に区画可能であって、容器を押圧した際には速やかに各々の薬剤室が連通可能であれば、構造は特に問わない。例えば、弱シール部に弱シール部形成用シートを咬ませて弱シール部を形成する場合、このシートは通常、最内層の材料と溶着強度の弱い樹脂が採用される。例えば、最内層がポリエチレンである場合、ポリエチレンとポリプロピレンとを3:7〜7:3に混合したポリマーブレンドが好適に採用される。最内層の材料と溶着強度の弱い樹脂を用いることによって、最内層と溶着しない箇所が弱シール部に点在するため弱シールが可能となる。また、最内層がポリエチレンとポリプロピレンとのポリマーブレンドである場合には、容器本体を200〜250℃で溶着し、弱シール部形成用シートを120℃前後で溶着して弱シール部を形成することによって、連通時の押圧によって容器周縁は剥離することなく弱シール部のみを剥離可能とする構造を達成することができる。   The structure of the weak seal 5 is not particularly limited as long as each drug chamber can be partitioned in a liquid-tight manner, and each drug chamber can be communicated quickly when the container is pressed. For example, when a weak seal portion is formed by biting a weak seal portion forming sheet into the weak seal portion, the innermost layer material and a resin having low welding strength are usually used for the sheet. For example, when the innermost layer is polyethylene, a polymer blend in which polyethylene and polypropylene are mixed at 3: 7 to 7: 3 is suitably employed. By using the resin of the innermost layer and the resin having a weak welding strength, weak seals are possible because the portions not welded to the innermost layer are scattered in the weak seal portion. When the innermost layer is a polymer blend of polyethylene and polypropylene, the container body is welded at 200 to 250 ° C., and the weak seal portion forming sheet is welded at around 120 ° C. to form a weak seal portion. Thus, it is possible to achieve a structure in which only the weak seal portion can be peeled without peeling off the peripheral edge of the container due to pressing during communication.

ポート3は筒状体であって、ポート下部の刺通口は栓体が装着されている。栓体のゴムには通常、イソプレンゴム、ブタジエンゴム等が用いられる。   The port 3 is a cylindrical body, and a stopper is attached to the piercing opening at the bottom of the port. Usually, isoprene rubber, butadiene rubber or the like is used as the rubber of the plug.

被覆部材4は、上部又は下部薬剤室に、各室が未連通の状態では脱離不能なように、収縮させることによって備えられ、例えば、ポリエチレン製やPET製のシュリンクフィルムで形成される。被覆部材4を容器本体Aに装着させる際には、熱処理により収縮させ、締め付け装着させるが、この時、処理条件により、収縮させすぎることのないように、部分収縮可能な部材を使用することがより好ましい。このようなものとしては、例えば、非収縮部であるポリプロピレンシートと収縮部であるPET製シュリンクフィルムとを繋ぎ合わせて形成する。熱処理をすることにより、PET製シュリンクフィルム部のみ収縮するため、このように、部分的に収縮するように形成することによって、収縮後のバンドの締め付けが好ましくなるよう適宜設計することが可能であり収縮しすぎて脱離しにくいということもない。取り付けに際しても、複室容器に取り付けた後に熱収縮をかけるので、容易に固定させることが可能である。   The covering member 4 is provided by contracting the upper or lower drug chamber so that each chamber cannot be detached when the chamber is not in communication, and is formed of, for example, a shrink film made of polyethylene or PET. When the covering member 4 is attached to the container main body A, it is contracted by heat treatment and tightened and attached. At this time, depending on the processing conditions, a member that can be partially contracted may be used so as not to contract too much. More preferred. For example, a polypropylene sheet that is a non-shrinkable portion and a PET shrink film that is a shrinkable portion are joined together. Since only the shrink film made of PET is shrunk by heat treatment, it can be designed appropriately so that tightening of the band after shrinkage is preferable by forming it so as to shrink partially. It does not shrink too much and is not easily detached. Also, since the heat shrinkage is applied after attaching to the multi-chamber container, it can be easily fixed.

被覆部材4が、被覆している薬剤室が膨張した際に破壊される手段として、図1や図2に図示されているように破線状の切り込み41を設けている。この時、破線状の切り込み41は図1及び図2に示されるように上端又は下端から、中央付近まで形成しても良いし、上端又は下端から、他端まで形成してもよく、また、破線の形状としては、単純な点線状等で形成され、切り込みの終点位置や形状は特に限定されるものではない。   As a means to be destroyed when the medicine chamber which the covering member 4 is covering expands, a broken line-shaped cut 41 is provided as shown in FIGS. At this time, the broken line-shaped cut 41 may be formed from the upper end or the lower end to the vicinity of the center as shown in FIGS. 1 and 2, or may be formed from the upper end or the lower end to the other end. The shape of the broken line is a simple dotted line or the like, and the end point position and shape of the cut are not particularly limited.

さらに、被覆部材4を容器本体Aより脱離する際に脱離しやすいように、被覆部材4に把持部42を設けてもよい。   Furthermore, a grip portion 42 may be provided on the covering member 4 so that the covering member 4 is easily detached when the covering member 4 is detached from the container body A.

被覆部材の上から誤って輸液具を連通することができないように、刺通口に硬質部材43を設けてもよい。穿刺妨害部材の材質および形状としては、輸液ラインの穿刺針でゴム栓体31を穿刺することを妨害できるものであれば特に限定されることはなく、材質としてはたとえば、PET、PP、PC等が挙げられ、形状も円盤状や曲面を下側に設けた半円球でもよい。または、硬質部材が刺通口よりずれないようにポートの最下面に対して凹部を形成するように刺通口を設け、その凹部に硬質部材を係合させる。このような硬質部材43を、例えばタンパーシール44などでポート刺通口を露出しないように貼着し、その上で被覆部材を容器本体に装着させる。特に、図4に示されるように、被覆部材がポートを被覆するタイプの場合には、硬質部材43を設けることによって、被覆部材がポートに被覆されている状態では、ポートよりタンパーシールを剥離し、刺通口から硬質部材を脱離することが不可能であるため、輸液ラインの穿刺が不可能となるので、確実に未連通時での使用を防ぐことができる。なお、被覆部材を脱離した際には、硬質部材を取り外し、速やかに使用可能となる。   The hard member 43 may be provided in the piercing opening so that the infusion device cannot be communicated by mistake from above the covering member. The material and shape of the puncture blocking member is not particularly limited as long as it can block the puncture of the rubber plug 31 with the puncture needle of the infusion line. Examples of the material include PET, PP, PC, and the like. The shape may also be a disc shape or a hemisphere with a curved surface on the lower side. Alternatively, a piercing port is provided so as to form a recess with respect to the lowermost surface of the port so that the hard member does not deviate from the piercing port, and the hard member is engaged with the recess. Such a hard member 43 is attached with, for example, a tamper seal 44 so as not to expose the port piercing opening, and then the covering member is attached to the container body. In particular, as shown in FIG. 4, in the case where the covering member covers the port, by providing a hard member 43, the tamper seal is peeled off from the port when the covering member is covered by the port. Since it is impossible to detach the hard member from the piercing opening, it is impossible to puncture the infusion line, so that it can be reliably prevented from being used when not connected. When the covering member is detached, the hard member can be removed and used quickly.

図1に示される医療用複室容器の使用方法を図5を用いて説明する。まず、上部薬剤室1を外部より押圧して弱シール部5を剥がし、下部薬剤室1と上部薬剤室2とを連通させる。連通することによって上部薬剤室2の薬剤が下部薬剤室1に移動し下部薬剤室1が膨張、その厚みが増大する。厚みが増大することによって、被覆部材4に形成された破線状の切り込み41が千切れ、被覆部材4の薬剤容器Aに対する実質的な締め付けが解除される。そのため、容器本体Aから被覆部材4が脱離可能となり、把持部42を掴んで被覆部材4を引き抜くと、被覆部材4によって覆われていた連通口31が露出する。このように、未薬液入りの上部薬剤室を押圧して各薬剤室を連通し、下部薬剤室に薬液が流入して厚みが増大することを利用して、連通手段と被覆手段の脱離とがリンクした構造となっている。上記構造をとることによって、複室が連通するまで連通口を被覆部材が被覆しているため、輸液ラインの穿刺を防ぐことができ、未連通状態で患者に薬液を投与するおそれがない。   A method of using the medical multi-chamber container shown in FIG. 1 will be described with reference to FIG. First, the upper drug chamber 1 is pressed from the outside, the weak seal portion 5 is peeled off, and the lower drug chamber 1 and the upper drug chamber 2 are communicated. By communicating, the medicine in the upper medicine chamber 2 moves to the lower medicine chamber 1, the lower medicine chamber 1 expands, and its thickness increases. By increasing the thickness, the broken line-shaped cuts 41 formed in the covering member 4 are broken, and the substantial tightening of the covering member 4 to the drug container A is released. Therefore, the covering member 4 can be detached from the container body A, and when the covering member 4 is pulled out by grasping the grip portion 42, the communication port 31 covered by the covering member 4 is exposed. In this way, the upper drug chamber containing the non-chemical solution is pressed to communicate with each drug chamber, and the chemical solution flows into the lower drug chamber to increase the thickness. Has a linked structure. By adopting the above structure, since the covering member covers the communication port until the multiple chambers communicate with each other, the infusion line can be prevented from being punctured, and there is no possibility of administering the drug solution to the patient in an unconnected state.

本発明の医療用複室容器は、上述のように薬剤容器の外周に取り付け可能な可撓性の被覆部材が設けられているため、薬剤容器の形状に依存せず容易に医療用複室容器に取り付け可能であり、各薬剤室が連通すると同時に被覆部材が破壊されるため、外れなくなるといったおそれもない。また、未連通の状態ではポートの刺通口が被覆されているので、未連通のままの調整されていない薬剤を誤って患者に投与することがないため医療に好適に用いることができる。   Since the medical multi-chamber container of the present invention is provided with the flexible covering member that can be attached to the outer periphery of the drug container as described above, the medical multi-chamber container can be easily used without depending on the shape of the drug container. Since the covering member is destroyed at the same time as the respective drug chambers communicate with each other, there is no possibility that they will not come off. In addition, since the port piercing port is covered in a non-communication state, an unadjusted medicine that remains uncommitted is not erroneously administered to a patient, and thus can be suitably used for medical treatment.

本発明の医療用複室容器のポートを被覆したタイプの一実施態様例の図。The figure of one embodiment of the type which coat | covered the port of the medical multiple chamber container of this invention. 本発明の医療用複室容器の吊り下げ孔を被覆したタイプの一実施態様例の図。The figure of one embodiment example of the type which coat | covered the suspension hole of the medical multiple-chamber container of this invention. 本発明の医療用複室容器の被覆部材に把持部を設けたタイプの一実施態様例の図。The figure of one embodiment of the type which provided the holding part in the coating | coated member of the medical multiple-chamber container of this invention. 本発明の医療用複室容器のポート刺通口に硬質部材を設けた図。The figure which provided the hard member in the port penetration port of the medical multiple-chamber container of this invention. 本発明の医療用複室容器の使用状態の図。The figure of the use condition of the medical multiple-chamber container of this invention.

符号の説明Explanation of symbols

A 容器本体
1 下部薬剤室
2 上部薬剤室
3 ポート
31 栓体
4 被覆部材
41 破線状の切り込み
42 把持部
43 硬質部材
44 タンパーシール
5 弱シール部
6 吊り下げ孔
A Container body 1 Lower drug chamber 2 Upper drug chamber 3 Port 31 Plug body 4 Cover member 41 Broken line-shaped cut 42 Gripping part 43 Hard member 44 Tamper seal 5 Weak seal part 6 Hanging hole

Claims (8)

薬剤入りの医療用複室容器であって、
剥離可能な弱シール部によって上部薬剤室と下部薬剤室とに液密に区画され、少なくとも前記上部薬剤室には薬液が封入されている可撓性の容器本体と、
前記容器本体の上部に設けられた吊り下げ孔と、
前記容器本体の下部に、前記下部薬剤室と連通するように設けられた刺通口を有するポートと、
前記下部薬剤室外周に係るように前記ポートごと収縮被覆する袋状の被覆部材とを含み、
前記被覆部材は、前記上部薬剤室を押圧して前記弱シール部を剥離し、各々の薬剤室を連通させると破壊され、前記容器本体より取り除くことが可能となることを特徴とする、
医療用複室容器。
A medical multi-chamber container containing a medicine,
A flexible container body that is liquid-tightly divided into an upper drug chamber and a lower drug chamber by a peelable weak seal, and at least the upper drug chamber is filled with a drug solution;
A suspension hole provided in the upper part of the container body;
A port having a piercing opening provided in the lower part of the container body so as to communicate with the lower drug chamber;
A bag-shaped covering member that shrinks and covers the entire port so as to relate to the outer periphery of the lower drug chamber,
The covering member presses the upper drug chamber, peels off the weak seal portion, is broken when each drug chamber is communicated, and can be removed from the container body,
Medical multi-chamber container.
前記被覆部材の下部であって、前記容器本体及び前記ポートに係らない領域に把持部を有する、請求項1に記載の医療用複室容器。   The medical multi-chamber container according to claim 1, further comprising a grip portion in a region below the covering member and not related to the container body and the port. 前記被覆部材には破壊されやすいように被覆部材上端から下方に向かって破線状の切り込みを有する、請求項1または2に記載の医療用複室容器。 The medical multi-chamber container according to claim 1 or 2, wherein the covering member has a broken line-like cut from the upper end of the covering member downward so as to be easily broken. 薬剤入りの医療用複室容器であって、
剥離可能な弱シール部によって上部薬剤室と下部薬剤室とに液密に区画され、少なくとも前記下部薬剤室には薬液が封入されている可撓性の容器本体と、
前記容器本体の上部に設けられた吊り下げ孔と、
前記容器本体の下部に、前記下部薬剤室と連通するように設けられた刺通口を有するポートと、
上部薬剤室の外周に係るように前記吊り下げ孔ごと収縮被覆する被覆部材とを含み、
前記被覆部材は、前記下部薬剤室を押圧して前記弱シール部を剥離し、各々の薬剤室を連通させると破壊され、前記容器本体より取り除くことが可能となることを特徴とする、
医療用複室容器。
A medical multi-chamber container containing a medicine,
A flexible container body that is liquid-tightly divided into an upper drug chamber and a lower drug chamber by a peelable weak seal portion, and at least the lower drug chamber is sealed with a drug solution;
A suspension hole provided in the upper part of the container body;
A port having a piercing opening provided in the lower part of the container body so as to communicate with the lower drug chamber;
A covering member that shrinks and covers the entire suspension hole so as to relate to the outer periphery of the upper drug chamber,
The covering member presses the lower drug chamber, peels off the weak seal portion, is broken when each drug chamber is communicated, and can be removed from the container body,
Medical multi-chamber container.
前記被覆部材の上部であって、前記容器本体に係らない領域に把持部を有する、請求項4に記載の医療用複室容器。   The medical multi-chamber container according to claim 4, wherein the medical multi-chamber container has a grip portion in an area which is an upper part of the covering member and is not related to the container main body. 前記被覆部材には破壊されやすいように被覆部材下端から上方に向かって破線状の切り込みを有する、請求項4または5に記載の医療用複室容器。   The medical multi-chamber container according to claim 4 or 5, wherein the covering member has a broken line-like cut from the lower end of the covering member so as to be easily broken. 前記被覆部材の少なくとも一部がシュリンクフィルムで形成されてなる、請求項1から6のいずれかに記載の医療用複室容器。   The medical multi-chamber container according to any one of claims 1 to 6, wherein at least a part of the covering member is formed of a shrink film. 前記刺通口に硬質部材が装着されてなる、請求項1から7のいずれかに記載の医療用複室容器。   The medical multi-chamber container according to any one of claims 1 to 7, wherein a hard member is attached to the piercing opening.
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Publication number Priority date Publication date Assignee Title
CN102834085A (en) * 2010-05-10 2012-12-19 德国梅尔松根B·布劳恩股份有限公司 Filling
US9962896B2 (en) 2008-02-27 2018-05-08 Fenwal, Inc. Peelable seals including porous inserts
CN114392189A (en) * 2022-01-13 2022-04-26 北京大学第三医院(北京大学第三临床医学院) Changeable multi-functional medicine box of cavity

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JPH0324311U (en) * 1989-07-08 1991-03-13
JP2005211558A (en) * 2004-02-02 2005-08-11 Kr Business:Kk Medical double-chamber container with unopened use preventive mechanism
JP2005245677A (en) * 2004-03-03 2005-09-15 Kr Business:Kk Medical multi-chamber container with unmixing-preventing mechanism
WO2005097039A1 (en) * 2004-04-08 2005-10-20 Ajinomoto Co., Inc. Medicine containing sealed body

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Publication number Priority date Publication date Assignee Title
JPH0324311U (en) * 1989-07-08 1991-03-13
JP2005211558A (en) * 2004-02-02 2005-08-11 Kr Business:Kk Medical double-chamber container with unopened use preventive mechanism
JP2005245677A (en) * 2004-03-03 2005-09-15 Kr Business:Kk Medical multi-chamber container with unmixing-preventing mechanism
WO2005097039A1 (en) * 2004-04-08 2005-10-20 Ajinomoto Co., Inc. Medicine containing sealed body

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9962896B2 (en) 2008-02-27 2018-05-08 Fenwal, Inc. Peelable seals including porous inserts
CN102834085A (en) * 2010-05-10 2012-12-19 德国梅尔松根B·布劳恩股份有限公司 Filling
CN114392189A (en) * 2022-01-13 2022-04-26 北京大学第三医院(北京大学第三临床医学院) Changeable multi-functional medicine box of cavity
CN114392189B (en) * 2022-01-13 2024-02-02 北京大学第三医院(北京大学第三临床医学院) Multifunctional medicine box with changeable cavity

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