JP2021058669A - Injection preparation storing container, container with injection preparation, usage for container with injection preparation and method for storing injection preparation in injection preparation storing container - Google Patents

Injection preparation storing container, container with injection preparation, usage for container with injection preparation and method for storing injection preparation in injection preparation storing container Download PDF

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JP2021058669A
JP2021058669A JP2020217737A JP2020217737A JP2021058669A JP 2021058669 A JP2021058669 A JP 2021058669A JP 2020217737 A JP2020217737 A JP 2020217737A JP 2020217737 A JP2020217737 A JP 2020217737A JP 2021058669 A JP2021058669 A JP 2021058669A
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container
injection
container body
insertion surface
opening
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JP7293185B2 (en
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孝之 池田
Takayuki Ikeda
孝之 池田
石川 浩二
Koji Ishikawa
浩二 石川
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Dai Nippon Printing Co Ltd
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Dai Nippon Printing Co Ltd
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Abstract

To provide an injection preparation storing container that eliminates the need of additionally fitting a structure for checking opening and can maintain quality of sanitary inside a container until when injection preparation is sucked.SOLUTION: An injection preparation storing container includes: a container body 11 having an insertion surface 13 for an injection needle at one side and an opening on the other side; a protective cover 12 for covering the insertion surface of the container body; and a connection part 15 for connecting the protective cover to the container body. The insertion surface can be penetrated with an injection needle, while the opening on the other side can be hermetically sealed. The connection part is crushed when the protective cover is removed so as to expose the insertion surface to the outside.SELECTED DRAWING: Figure 1

Description

本発明は、注射剤収納用容器、注射剤入り容器、注射剤入り容器の使用方法、および、注射剤収納用容器に注射剤を収納する方法に関する。 The present invention relates to a container for storing an injection, a container containing an injection, a method for using the container containing an injection, and a method for storing an injection in the container for storing an injection.

注射剤を保存または輸送するための容器には、密封状態を安定して保持することが求められている。このような容器として、通常、ガラス製またはプラスチック製のアンプル瓶あるいはバイアル瓶が用いられている(例えば、特許文献1参照)。 Containers for storing or transporting injections are required to maintain a stable sealed state. As such a container, an ampoule bottle or a vial bottle made of glass or plastic is usually used (see, for example, Patent Document 1).

また、このような容器には、安全を確保する目的で、容器の開封、未開封を容易に識別できるような構造であることが求められている。例えば、日本国の場合、薬事法施行規則第219条に規定がある。 Further, for the purpose of ensuring safety, such a container is required to have a structure that allows easy identification of opened and unopened containers. For example, in the case of Japan, there is a provision in Article 219 of the Pharmaceutical Affairs Law Enforcement Regulations.

例えば、バイアル瓶では、容器本体の開口から容器本体に注射剤が注入された後に、キャップが容器本体の開口に嵌合されることで密封され、次に、開封確認のための構造として、シュリンクラベルが巻き付けられ、もしくはバージンシールが貼り付けられる。バイアル瓶の使用時には、それらが剥がされることで開封確認が可能となる。 For example, in a vial, after an injection is injected into the container body through the opening of the container body, the cap is fitted into the opening of the container body to seal the bottle, and then shrink as a structure for confirming opening. A label is wrapped or a virgin seal is attached. When using vials, they can be peeled off to confirm opening.

一方、アンプル瓶では、容器本体の開口から容器本体に注射剤が注入された後に、容器本体の開口がヒートシールされて密封される。アンプル瓶の使用時には、注射針挿入口を形成するために容器の一部が予め切り取られることで、開封確認が可能となる。 On the other hand, in an ampoule bottle, after the injection is injected into the container body through the opening of the container body, the opening of the container body is heat-sealed and sealed. When using an ampoule bottle, a part of the container is cut out in advance to form an injection needle insertion port, so that the opening can be confirmed.

実開昭61−159933号公報Jikkai Sho 61-159933

ところで、バイアル瓶では、注射剤が注入されて密封された後に、開封確認のための構造として、シュリンクラベルが巻き付けられ、またはバージンシールが貼り付けられる。すなわち、密封作業とは別に開封確認のための構造の取り付け作業が行われるため、製造上の手間がかかる。また、密封作業の後に開封確認のための構造の取り付け作業が行われるため、開封確認のための構造の取り付け作業は、バイアル瓶の製造業者では無く、注射剤入り容器の製造業者で行われる。そのため、注射剤入り容器の製造業者は、注射剤を注入して密封するための設備だけでなく、開封確認のための構造を取り付けるための設備をも別途に用意する必要があり、負担が大きい。 By the way, in the vial, after the injection is injected and sealed, a shrink label is wrapped or a virgin seal is attached as a structure for confirming opening. That is, since the structure for confirming the opening is attached separately from the sealing work, it takes time and effort in manufacturing. Further, since the structure for confirming the opening is attached after the sealing work, the work for attaching the structure for confirming the opening is performed not by the manufacturer of the vial but by the manufacturer of the container containing the injection. Therefore, the manufacturer of the container containing an injection needs to separately prepare not only the equipment for injecting the injection and sealing, but also the equipment for attaching the structure for confirming the opening, which is a heavy burden. ..

一方、アンプル瓶では、注射剤の密封作業と同時に開封確認のための構造が自動的に作製されるため、製造上の手間はかからないが、注射針挿入前に容器の一部を予め切り取ることで、容器内が外気に開放される。そのため、容器の一部を切り取ってから注射針を挿入して注射剤を吸引するまでの間に容器内の衛生面の質が低下するという問題もある。 On the other hand, in the ampoule bottle, since the structure for confirming the opening is automatically created at the same time as the sealing work of the injection, it does not require any manufacturing effort, but by cutting out a part of the container in advance before inserting the injection needle. , The inside of the container is opened to the outside air. Therefore, there is also a problem that the quality of hygiene in the container deteriorates between the time when a part of the container is cut off and the time when the injection needle is inserted and the injection is sucked.

本発明は、以上のような問題点に着目し、これを有効に解決すべく創案されたものである。本発明の目的は、開封確認のための構造を別に取り付ける必要が無く、且つ、注射剤を吸引する時まで容器内の衛生面の質を維持することができる注射剤収納用容器を提供することにある。また、本発明の目的は、そのような注射剤収納用容器を用いた注射剤入り容器を提供することにある。 The present invention has been devised in order to effectively solve the above problems by paying attention to the above problems. An object of the present invention is to provide a container for storing an injection, which does not require a separate structure for confirming opening and can maintain the hygienic quality in the container until the time when the injection is aspirated. It is in. Another object of the present invention is to provide a container containing an injection using such a container for storing an injection.

本発明の注射剤収納用容器は、
一側に注射針の挿入面を有し、他側が開口する容器本体と、
前記容器本体の前記挿入面を覆う保護カバーと、
前記保護カバーと前記容器本体とを連結する連結部と、
を備え、
前記挿入面は、注射針が貫通可能であり、
前記他側の開口は、密封可能であり、
前記連結部は、前記挿入面が露出するように前記保護カバーが外される際に破壊される。
本発明の注射剤収納用容器において、前記他側の開口は、当該他側の開口を構成する壁面同士が密着された状態で密封可能であってもよい。
本発明の注射剤収納用容器において、前記他側の開口を構成する壁面は、その周囲の部分と同じ厚みかもしくは肉薄であってもよい。
本発明の注射剤収納用容器において、前記挿入面は、前記容器本体の前記挿入面側の端部の内周面に設けられた補強リブにより補強されていてもよい。
本発明の注射剤収納用容器は、前記保護カバーと前記容器本体とを連結する第2連結部を更に備え、前記保護カバーは、前記第2連結部をヒンジ軸として、前記挿入面から遠ざかる向きに回動可能であってもよい。
本発明の注射剤収納用容器において、前記容器本体の前記挿入面側の端部の内周面には、前記挿入面に近づくにつれて前記容器本体内の容積を狭くする傾斜部が設けられていてもよい。
本発明の注射剤入り容器は、
一側に注射針の挿入面を有し、他側が開口する容器本体と、
前記容器本体の前記挿入面を覆う保護カバーと、
前記保護カバーと前記容器本体とを連結する連結部と、
を有し、
前記挿入面は、注射針が貫通可能であり、
前記他側の開口は、密封可能であり、
前記連結部は、前記挿入面が露出するように前記保護カバーが外される際に破壊される、という注射剤収納用容器と、
前記注射剤収納用容器の前記容器本体に収納された注射剤と、
を備え、
前記容器本体の前記他側の開口は密封されている。
本発明は、前記された注射剤入り容器の使用方法であって、
前記連結部を破壊しながら前記保護カバーを退けて前記挿入面を露出させる工程と、
前記容器本体の外方から注射針を前記挿入面に突き刺して前記注射剤を吸引する工程
を備える。
本発明は、一側に注射針の挿入面を有し、他側が開口する容器本体と、
前記容器本体の前記挿入面を覆う保護カバーと、
前記保護カバーと前記容器本体とを連結する連結部と、
を有し、
前記挿入面は、注射針が貫通可能であり、
前記他側の開口は、密封可能であり、
前記連結部は、前記挿入面が露出するように前記保護カバーが外される際に破壊される、という注射剤収納用容器に注射剤を収納する方法であって、
前記容器本体の前記他側の開口から当該容器本体に注射剤を注入する工程と、
前記容器本体の前記他側の開口を密封する工程と、
を備える。
The container for storing an injection of the present invention
A container body that has an injection needle insertion surface on one side and opens on the other side,
A protective cover that covers the insertion surface of the container body,
A connecting portion that connects the protective cover and the container body,
With
The insertion surface is piercable by an injection needle.
The opening on the other side can be sealed and
The connecting portion is broken when the protective cover is removed so that the insertion surface is exposed.
In the injection container for storing the injection of the present invention, the opening on the other side may be sealed in a state where the wall surfaces constituting the opening on the other side are in close contact with each other.
In the injection container of the present invention, the wall surface forming the opening on the other side may be the same thickness or thin as the surrounding portion.
In the injection container for storing the injection of the present invention, the insertion surface may be reinforced by reinforcing ribs provided on the inner peripheral surface of the end of the container body on the insertion surface side.
The container for storing an injection of the present invention further includes a second connecting portion for connecting the protective cover and the container body, and the protective cover is oriented away from the insertion surface with the second connecting portion as a hinge axis. May be rotatable.
In the container for storing injections of the present invention, an inclined portion that narrows the volume inside the container body as it approaches the insertion surface is provided on the inner peripheral surface of the end portion of the container body on the insertion surface side. May be good.
The container containing the injection of the present invention
A container body that has an injection needle insertion surface on one side and opens on the other side,
A protective cover that covers the insertion surface of the container body,
A connecting portion that connects the protective cover and the container body,
Have,
The insertion surface is piercable by an injection needle.
The opening on the other side can be sealed and
The connecting portion is destroyed when the protective cover is removed so that the insertion surface is exposed, and an injection storage container.
The injection stored in the container body of the injection storage container and
With
The opening on the other side of the container body is sealed.
The present invention is the method of using the above-mentioned container containing an injection.
A step of removing the protective cover to expose the insertion surface while breaking the connecting portion, and a step of exposing the insertion surface.
A step is provided in which an injection needle is pierced into the insertion surface from the outside of the container body to suck the injection.
The present invention includes a container body having an injection needle insertion surface on one side and an opening on the other side.
A protective cover that covers the insertion surface of the container body,
A connecting portion that connects the protective cover and the container body,
Have,
The insertion surface is piercable by an injection needle.
The opening on the other side can be sealed and
The connecting portion is a method of storing an injection in an injection storage container, which is destroyed when the protective cover is removed so that the insertion surface is exposed.
A step of injecting an injection into the container body through the opening on the other side of the container body,
The step of sealing the opening on the other side of the container body and
To be equipped.

本発明によれば、開封確認のための構造を別に取り付ける必要が無く、且つ、注射剤を吸引する時まで容器内の衛生面の質を維持することができる。 According to the present invention, it is not necessary to separately attach a structure for confirming opening, and the quality of hygiene in the container can be maintained until the time when the injection is aspirated.

図1は、本発明の一実施の形態による注射剤収納用容器を立体的に示す断面図である。FIG. 1 is a cross-sectional view showing a three-dimensional injection container according to an embodiment of the present invention. 図2は、図1の注射剤収納用容器の一部を拡大して立体的に示す断面図である。FIG. 2 is an enlarged and three-dimensional cross-sectional view of a part of the injection storage container of FIG. 図3は、図2の注射剤収納用容器のA−A線に沿った断面図である。FIG. 3 is a cross-sectional view taken along the line AA of the injection storage container of FIG. 図4は、図1の注射剤収納用容器を用いた注射剤入り容器を立体的に示す断面図である。FIG. 4 is a three-dimensional cross-sectional view showing a container containing an injection using the container for storing the injection of FIG. 1. 図5は、図4の注射剤入り容器において保護カバーを外して挿入面を露出させる工程を説明するための図である。FIG. 5 is a diagram for explaining a step of removing the protective cover to expose the insertion surface in the container containing the injection of FIG. 4. 図6は、図4の注射剤入り容器から注射剤を吸引する工程を説明するための図である。FIG. 6 is a diagram for explaining a step of sucking the injection from the container containing the injection of FIG. 図7は、図2に対応する断面図であって、挿入面が補強リブにより補強されている態様を説明するための図である。FIG. 7 is a cross-sectional view corresponding to FIG. 2 and is a view for explaining an embodiment in which the insertion surface is reinforced by the reinforcing ribs. 図8は、図2に対応する断面図であって、容器本体の天井部にストッパが設けられている態様を説明するための図である。FIG. 8 is a cross-sectional view corresponding to FIG. 2, and is a diagram for explaining an embodiment in which a stopper is provided on the ceiling portion of the container body.

以下に、添付の図面を参照して、本発明の実施の形態を詳細に説明する。なお、本明細書に添付する図面においては、図示の理解のしやすさの便宜上、適宜縮尺および縦横の寸法比等を、実物のそれらから変更し誇張してある。 Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the drawings attached to the present specification, the scale, aspect ratio, etc. are appropriately changed from those of the actual product and exaggerated for the convenience of easy understanding of the illustration.

図1は、本発明の一実施の形態による注射剤収納用容器を立体的に示す断面図である。図2は、図1の注射剤収納用容器の一部を拡大して立体的に示す断面図である。図3は、図2の注射剤収納用容器のA−A線に沿った断面図である。 FIG. 1 is a cross-sectional view showing a three-dimensional injection container according to an embodiment of the present invention. FIG. 2 is an enlarged and three-dimensional cross-sectional view of a part of the injection storage container of FIG. FIG. 3 is a cross-sectional view taken along the line AA of the injection storage container of FIG.

図1乃至図3に示すように、本実施の形態による注射剤収納用容器10は、一側に注射針の挿入面13を有し、他側が開口する容器本体11と、容器本体11の挿入面13を覆う保護カバー12と、保護カバー12と容器本体11とを連結する連結部15と、を備えている。 As shown in FIGS. 1 to 3, the injection storage container 10 according to the present embodiment has a container body 11 having an injection needle insertion surface 13 on one side and an opening on the other side, and insertion of the container body 11. A protective cover 12 that covers the surface 13 and a connecting portion 15 that connects the protective cover 12 and the container body 11 are provided.

このうち容器本体11は、略円筒形状の胴部と、胴部の一端を閉塞する天井部11bと、を有している。胴部の一端を閉塞する天井部11bに注射針の挿入面13が設けられており、胴部の他端に開口14が設けられている。 Of these, the container body 11 has a substantially cylindrical body portion and a ceiling portion 11b that closes one end of the body portion. An injection needle insertion surface 13 is provided on the ceiling portion 11b that closes one end of the body portion, and an opening 14 is provided on the other end of the body portion.

容器本体11の軸線方向の長さは、例えば30mm〜40mmであり、容器本体11の直径は、例えば10mm〜20mmである。 The axial length of the container body 11 is, for example, 30 mm to 40 mm, and the diameter of the container body 11 is, for example, 10 mm to 20 mm.

容器本体11の他側の開口14は、密封可能となっている。容器本体11の他側の開口14は、当該他側の開口14を構成する壁面11a同士が密着された状態で密封可能となっていることが好ましい。この場合、容器本体11の開口14にキャップを嵌合させることなく密封できるため、毎回安定して密封することができるとともに、輸送等の振動があっても密封状態を安定して保持することができる。また、この場合、部品点数が少なくなる。他側の開口14を構成する壁面11a同士が密着された状態での密封としては、例えばヒートシールによる密封や、接着剤による密封が挙げられる。他側の開口14を構成する壁面11a同士が密着された状態での密封を容易にするために、容器本体11の他側の開口14を構成する壁面11aは、その周囲の部分、すなわち当該壁面11aに対して天井部11b側から隣接する部分、と同じ厚みかもしくはより肉薄であることが好ましい。具体的には、例えば、容器本体11の胴部のうち開口14を構成する壁面11aの厚みT3は、0.5mmであり、胴部のうち他の部分の厚みT2は、1.5mmである。 The opening 14 on the other side of the container body 11 can be sealed. It is preferable that the opening 14 on the other side of the container body 11 can be sealed in a state where the wall surfaces 11a constituting the opening 14 on the other side are in close contact with each other. In this case, since the container body 11 can be sealed without fitting the cap into the opening 14, the container body 11 can be sealed stably every time, and the sealed state can be stably maintained even if there is vibration such as transportation. it can. Further, in this case, the number of parts is reduced. Examples of the sealing in a state where the wall surfaces 11a constituting the opening 14 on the other side are in close contact with each other include sealing with a heat seal and sealing with an adhesive. In order to facilitate sealing in a state where the wall surfaces 11a forming the other side opening 14 are in close contact with each other, the wall surface 11a forming the other side opening 14 of the container body 11 is a peripheral portion, that is, the wall surface. It is preferable that the thickness is the same as or thinner than the portion adjacent to the ceiling portion 11b side with respect to 11a. Specifically, for example, the thickness T3 of the wall surface 11a forming the opening 14 of the body of the container body 11 is 0.5 mm, and the thickness T2 of the other part of the body is 1.5 mm. ..

また、図示された例では、容器本体11の挿入面13は、その周囲の部分より肉薄であって、注射針が容易に貫通可能となっている。挿入面13の厚みT1は、例えば0.7mmである。(校閲用注釈:図面は、容器を斜め上から見下ろした形態を示しており、符号12、13の示す場所のドーム状の線は、奥側の輪郭線を示しています。) Further, in the illustrated example, the insertion surface 13 of the container body 11 is thinner than the peripheral portion thereof, so that the injection needle can easily penetrate the container body 11. The thickness T1 of the insertion surface 13 is, for example, 0.7 mm. (Review Note: The drawing shows the container looking down from diagonally above, and the dome-shaped lines at the locations indicated by symbols 12 and 13 indicate the contour lines on the back side.)

図1及び図2に示すように、容器本体11の挿入面13は、保護カバー12により覆われており、衛生性が確保されるようになっている。 As shown in FIGS. 1 and 2, the insertion surface 13 of the container body 11 is covered with a protective cover 12 to ensure hygiene.

図示された例では、保護カバー12は、略円板形状を有しており、容器本体11の外方において挿入面13と対向して位置決めされている。保護カバー12の直径は、容器本体11の天井部11bの直径と同程度であり、例えば10mm〜20mmである。保護カバー12の外縁部のうち円周方向の一部には、径方向外向きに突出する鍔部12aが設けられている。 In the illustrated example, the protective cover 12 has a substantially disk shape and is positioned on the outer side of the container body 11 so as to face the insertion surface 13. The diameter of the protective cover 12 is about the same as the diameter of the ceiling portion 11b of the container body 11, for example, 10 mm to 20 mm. A flange portion 12a that projects outward in the radial direction is provided on a part of the outer edge portion of the protective cover 12 in the circumferential direction.

図2に示すように、保護カバー12と容器本体11とは、連結部15および第2連結部16により連結されている。 As shown in FIG. 2, the protective cover 12 and the container body 11 are connected by a connecting portion 15 and a second connecting portion 16.

より詳しくは、連結部15および第2連結部16は、それぞれ、容器本体11の天井部11bのうち挿入面13を取り囲む周縁部と保護カバー12の周縁部との間に挟まれるように設けられている。これにより、連結部15および第2連結部16が外方に突き出すことが無く、保管時および搬送時における占有スペースがコンパクトになる。また、図3に示すように、連結部15は、円周方向において鍔部12aに対応する角度位置に位置決めされており、第2連結部16は、円周方向において連結部15とは180°離れた角度位置に位置決めされている。 More specifically, the connecting portion 15 and the second connecting portion 16 are provided so as to be sandwiched between the peripheral edge portion surrounding the insertion surface 13 and the peripheral edge portion of the protective cover 12 in the ceiling portion 11b of the container body 11, respectively. ing. As a result, the connecting portion 15 and the second connecting portion 16 do not protrude outward, and the occupied space during storage and transportation becomes compact. Further, as shown in FIG. 3, the connecting portion 15 is positioned at an angle position corresponding to the flange portion 12a in the circumferential direction, and the second connecting portion 16 is 180 ° with the connecting portion 15 in the circumferential direction. It is positioned at a distant angle position.

図示された例では、連結部15および第2連結部16は、それぞれ長方形状の断面を有しており、当該断面の1辺の長さは、例えば0.3mm〜1.0mmである。 In the illustrated example, the connecting portion 15 and the second connecting portion 16 each have a rectangular cross section, and the length of one side of the cross section is, for example, 0.3 mm to 1.0 mm.

このうち連結部15は、挿入面13が露出するように保護カバー12が外される際に、破壊可能となっている。一方、第2連結部16は、挿入面13が露出するように保護カバー12が外される際に、ヒンジ軸として機能するようになっている。 Of these, the connecting portion 15 can be destroyed when the protective cover 12 is removed so that the insertion surface 13 is exposed. On the other hand, the second connecting portion 16 functions as a hinge shaft when the protective cover 12 is removed so that the insertion surface 13 is exposed.

図示された例では、連結部15には軸方向の一部に「くびれ」が形成されており、軸方向の引っ張り力に対する強度が低下されている。そのため、図5に示すように、保護カバー12の鍔部12aに上向きの外力が加えられて保護カバー12が第2連結部16をヒンジ軸として挿入面13から遠ざかる向きに回動されると、連結部15に軸方向の引っ張り力がかかり、連結部15は「くびれ」部分において破壊されるようになっている。 In the illustrated example, the connecting portion 15 is formed with a "neck" in a part in the axial direction, and the strength against the tensile force in the axial direction is reduced. Therefore, as shown in FIG. 5, when an upward external force is applied to the flange portion 12a of the protective cover 12, the protective cover 12 is rotated in a direction away from the insertion surface 13 with the second connecting portion 16 as a hinge axis. A tensile force in the axial direction is applied to the connecting portion 15, and the connecting portion 15 is destroyed at the "necked" portion.

また、図示された例では、第2連結部16にも軸方向の一部に「くびれ」が形成されており、保護カバー12が第2連結部16をヒンジ軸として挿入面13から遠ざかる向きに回動される際に、第2連結部16は「くびれ」部分において容易に湾曲または屈曲されるようになっている。第2連結部16の「くびれ」の断面積は、連結部15の「くびれ」の断面積より大きいことが好ましい。この場合、保護カバー12が第2連結部16をヒンジ軸として挿入面13から遠ざかる向きに回動される際に、第2連結部16が不所望に破壊されてしまうことを抑制できる。 Further, in the illustrated example, the second connecting portion 16 also has a "neck" formed in a part in the axial direction, and the protective cover 12 is oriented away from the insertion surface 13 with the second connecting portion 16 as a hinge axis. When rotated, the second connecting portion 16 is adapted to be easily curved or bent at the "neck" portion. The cross-sectional area of the "neck" of the second connecting portion 16 is preferably larger than the cross-sectional area of the "neck" of the connecting portion 15. In this case, when the protective cover 12 is rotated with the second connecting portion 16 as a hinge axis in a direction away from the insertion surface 13, it is possible to prevent the second connecting portion 16 from being undesirably broken.

本実施の形態では、図2に示すように、容器本体11の胴部のうち挿入面13側の端部の内周面には、挿入面13に近づくにつれて容器本体11内の容積を狭くする傾斜部17が設けられている。図示された例では、傾斜部17は、その内側に切頭円錐形状の収容空間を画成するように、円周方向に沿ってリング状に設けられている。傾斜部17により画成される収容空間の挿入面13側の端部の内径は、他側の端部の内径より小さくされている。 In the present embodiment, as shown in FIG. 2, the volume inside the container body 11 is reduced as it approaches the insertion surface 13 on the inner peripheral surface of the end portion of the body of the container body 11 on the insertion surface 13 side. An inclined portion 17 is provided. In the illustrated example, the inclined portion 17 is provided in a ring shape along the circumferential direction so as to define a conical accommodation space inside the inclined portion 17. The inner diameter of the end portion on the insertion surface 13 side of the accommodation space defined by the inclined portion 17 is smaller than the inner diameter of the end portion on the other side.

以上のような構成からなる注射剤収納用容器10は、例えば、割型の金型を使用した樹脂の射出成形により一体に、すなわち一部品として作製され得る。注射剤収納用容器10の材質としては、好ましくは透明な樹脂が用いられ、具体的には、例えば、ポリエチレン(PE)、ポリプロピレン(PP)、シクロオレフィンポリマー(COP)等が用いられる。注射剤収納用容器10が一部品として射出成形されることで、部品点数が減り、製造時の部品管理が容易となる。 The injection container 10 having the above configuration can be manufactured integrally, that is, as one part, for example, by injection molding of a resin using a split mold. A transparent resin is preferably used as the material of the injection container 10, and specifically, for example, polyethylene (PE), polypropylene (PP), cycloolefin polymer (COP), or the like is used. Since the injection container 10 is injection-molded as one part, the number of parts is reduced and the parts can be easily managed at the time of manufacturing.

なお、本実施の形態では、注射剤収納用容器10は、割型の金型を使用した樹脂の射出成形により一体に、すなわち一部品として作製されているが、これに限定されず、例えば、容器本体11と保護カバー12とが別体に、すなわち2部品として射出成形され、別体に射出成形された保護カバー12が容器本体11の天井部11bに接着剤により接着固定されてもよい。この場合、固化した接着剤によって連結部15が形成され得る。 In the present embodiment, the injection container 10 is manufactured integrally by injection molding of a resin using a split mold, that is, as one part, but the present invention is not limited to this, and for example, The container body 11 and the protective cover 12 may be injection-molded separately, that is, as two parts, and the protective cover 12 injection-molded into the separate body may be adhesively fixed to the ceiling portion 11b of the container body 11 with an adhesive. In this case, the solidified adhesive may form the connecting portion 15.

次に、以上のような注射剤収納用容器10を用いた注射剤入り容器20について説明する。 Next, the injection container 20 using the injection storage container 10 as described above will be described.

図4は、本実施の形態による注射剤入り容器20を示す概略側面図である。 FIG. 4 is a schematic side view showing a container 20 containing an injection according to the present embodiment.

図4に示すように、本実施の形態による注射剤入り容器20は、注射剤収納用容器10と、注射剤収納用容器10の容器本体11に収納された注射剤21と、を備えており、容器本体11の他側の開口14が当該他側の開口14を構成する壁面11a同士が密着された状態で、例えばヒートシールにより密封されている。図4の符号18は、ヒートシールされた部分を示している。 As shown in FIG. 4, the container 20 containing an injection according to the present embodiment includes an injection storage container 10 and an injection 21 stored in the container body 11 of the injection storage container 10. The opening 14 on the other side of the container body 11 is sealed by, for example, a heat seal in a state where the wall surfaces 11a constituting the opening 14 on the other side are in close contact with each other. Reference numeral 18 in FIG. 4 indicates a heat-sealed portion.

容器本体11に収納される注射剤21の容量は、例えば1ml〜2mlである。注射剤21の種類は、特に限定されないが、例えば樹状細胞を含有する注射用保存液が想定される。 The volume of the injection 21 stored in the container body 11 is, for example, 1 ml to 2 ml. The type of injection 21 is not particularly limited, but for example, an injection preservative solution containing dendritic cells is assumed.

次に、このような注射剤入り容器20の製造方法、すなわち注射剤収納用容器10に注射剤21を収納する方法を説明する。 Next, a method for manufacturing such an injection-containing container 20, that is, a method for storing the injection 21 in the injection storage container 10 will be described.

まず、図1に示すような注射剤収納用容器10が準備され、容器本体11の開口14が上向きに向けられる。 First, the injection storage container 10 as shown in FIG. 1 is prepared, and the opening 14 of the container body 11 is directed upward.

次に、容器本体11の開口14が上向きに向けられた状態で、当該開口14から容器本体11の内部に注射剤21が注入される。後述するヒートシールにより注射剤21が熱変性されることを防止するために、容器本体11内に注入された注射剤21の液面は、容器本体11の開口14を構成する壁面から25mm程度離れて位置することが好ましい。 Next, the injection 21 is injected into the inside of the container body 11 through the opening 14 with the opening 14 of the container body 11 facing upward. In order to prevent the injection 21 from being thermally denatured by the heat seal described later, the liquid level of the injection 21 injected into the container body 11 is separated from the wall surface forming the opening 14 of the container body 11 by about 25 mm. It is preferable to be located.

次に、容器本体11の開口14が上向きに向けられた状態で、容器本体11の開口14が当該他側の開口14を構成する壁面11a同士が密着された状態で、例えばヒートシールにより密封される。 Next, with the opening 14 of the container body 11 facing upward, the opening 14 of the container body 11 is sealed with, for example, a heat seal in a state where the wall surfaces 11a constituting the opening 14 on the other side are in close contact with each other. To.

次に、このような注射剤入り容器20の使用方法を説明する。 Next, a method of using such a container 20 containing an injection will be described.

まず、注射剤21が収納された注射剤入り容器20が用意される。注射剤入り容器20のうち注射針の挿入面13は、保護カバー12により覆われて、清潔に保たれている。 First, a container 20 containing an injection agent containing the injection agent 21 is prepared. The insertion surface 13 of the injection needle in the injection container 20 is covered with the protective cover 12 and kept clean.

次に、図5に示すように、保護カバー12の鍔部12aに上向きの外力が加えられて保護カバー12が第2連結部16をヒンジ軸として挿入面13から遠ざかる向きに回動されることで、挿入面13が外方に露出される。この時、第2連結部16がその「くびれ」部分において湾曲または屈曲されるとともに、連結部15に軸方向の引っ張り力がかかり、連結部15はその「くびれ」部分において破壊される。 Next, as shown in FIG. 5, an upward external force is applied to the flange portion 12a of the protective cover 12, and the protective cover 12 is rotated in a direction away from the insertion surface 13 with the second connecting portion 16 as a hinge axis. Then, the insertion surface 13 is exposed to the outside. At this time, the second connecting portion 16 is curved or bent at the "necked" portion, and an axial pulling force is applied to the connecting portion 15, and the connecting portion 15 is broken at the "necked" portion.

連結部15が破壊されることで、容器20が使用された可能性があることを容易に識別することができ、すなわち開封確認が可能となる。 By breaking the connecting portion 15, it is possible to easily identify that the container 20 may have been used, that is, it is possible to confirm the opening.

また、第2連結部16は破壊されずに湾曲されることで、保護カバー12は容器本体11から分離されずに連結されたまま残る。これにより、分離された保護カバー12が落下して、現場が散らかってしまうことを防止できる。 Further, since the second connecting portion 16 is curved without being broken, the protective cover 12 remains connected without being separated from the container main body 11. As a result, it is possible to prevent the separated protective cover 12 from falling and cluttering the site.

次に、図6に示すように、容器本体11の挿入面13が下向きに向けられた状態で、注射器22の注射針23が容器本体11の外方から挿入面13に突き刺され、注射針23の先端が容器本体11に収納された注射剤21中に浸漬される。そして、注射器22のピストン24が引かれてシリンジ25の内部に負圧が形成されることで、容器本体11から注射針23を通ってシリンジ25の内部に注射剤21が吸引される。 Next, as shown in FIG. 6, the injection needle 23 of the syringe 22 is pierced into the insertion surface 13 from the outside of the container body 11 with the insertion surface 13 of the container body 11 facing downward, and the injection needle 23 is inserted. The tip of the needle is immersed in the injection 21 stored in the container body 11. Then, the piston 24 of the syringe 22 is pulled to form a negative pressure inside the syringe 25, so that the injection agent 21 is sucked from the container body 11 through the injection needle 23 into the inside of the syringe 25.

本実施の形態では、挿入面13に近づくにつれて容器本体11内の容積を狭くする傾斜部17が設けられているため、容器本体11内の注射剤21の量が少なくなった時に隅部などに液溜まりが生じて吸引できなくなることが抑制され、所望量の注射剤21を確実に吸引することが可能である。 In the present embodiment, since the inclined portion 17 that narrows the volume in the container body 11 as it approaches the insertion surface 13 is provided, when the amount of the injection 21 in the container body 11 decreases, the corner portion or the like is provided. It is possible to suppress the formation of a liquid pool and the inability to aspirate, and to reliably aspirate the desired amount of the injection 21.

以上のような本実施の形態によれば、挿入面13が露出するように保護カバー12が外される際に連結部15が破壊されることで、容器20が使用された可能性があることを容易に識別することが可能となる。したがって、バイアル瓶のように、開封確認のための構造として、シュリンクラベルを巻き付けたり、もしくはバージンシールを貼り付けたりする必要が無く、製造上の手間がかからない。 According to the present embodiment as described above, there is a possibility that the container 20 has been used because the connecting portion 15 is broken when the protective cover 12 is removed so that the insertion surface 13 is exposed. Can be easily identified. Therefore, unlike a vial, there is no need to wrap a shrink label or affix a virgin seal as a structure for confirming opening, and there is no manufacturing effort.

また、本実施の形態によれば、容器本体11の一側には注射針23が容易に貫通可能な挿入面13が設けられているため、注射剤吸引時に容器本体11の挿入面13に注射針23を直接突き刺して注射剤21を吸引することができる。これにより、アンプル瓶のように容器の一部を切り取って容器内を外気に開放する必要が無く、注射剤を吸引する時まで容器内の衛生面の質を維持することが可能である。 Further, according to the present embodiment, since the insertion surface 13 through which the injection needle 23 can easily penetrate is provided on one side of the container body 11, the injection surface 13 of the container body 11 is injected when the injection is sucked. The injection 21 can be sucked by directly piercing the needle 23. As a result, unlike an ampoule bottle, it is not necessary to cut out a part of the container to open the inside of the container to the outside air, and it is possible to maintain the hygienic quality inside the container until the time when the injection is aspirated.

なお、前述の実施の形態に対して様々な変更を加えることが可能である。 It is possible to make various changes to the above-described embodiment.

例えば、図7に示すように、注射針の挿入面13は容器本体11の挿入面13側の端部の内周面に設けられた補強リブ31により補強されていてもよい。図示された例では、容器本体11内において4枚の補強リブ31が、円周方向に対して90°おきに設けられており、各補強リブ31の肉厚は、1.0mmである。補強リブ31は、容器本体11の他の部分と一体に射出成形されている。挿入面13はその周囲の部分より肉薄であるが、このように補強リブ31により補強されることで、注射剤吸引時において注射針23が容易に貫通可能でありながら、保存時および輸送時において構造物としての強度を改善することが可能である。 For example, as shown in FIG. 7, the insertion surface 13 of the injection needle may be reinforced by a reinforcing rib 31 provided on the inner peripheral surface of the end portion of the container body 11 on the insertion surface 13 side. In the illustrated example, four reinforcing ribs 31 are provided in the container main body 11 at intervals of 90 ° with respect to the circumferential direction, and the wall thickness of each reinforcing rib 31 is 1.0 mm. The reinforcing rib 31 is injection-molded integrally with other parts of the container body 11. The insertion surface 13 is thinner than the surrounding portion, but by being reinforced by the reinforcing ribs 31 in this way, the injection needle 23 can be easily penetrated at the time of suction of the injection agent, and at the time of storage and transportation. It is possible to improve the strength as a structure.

また、図8に示すように、容器本体11の天井部11bには外方に突き出すようにストッパ32が設けられていてもよい。この場合、容器本体11の外方から挿入面13に注射針23が突き刺される際に、ストッパ32の先端がシリンジ25の端部に当接することで、注射針23の更なる挿入が規制され、注射針23の先端が容器本体11のヒートシールされた部分18を突き破ってしまうことを防止できる。 Further, as shown in FIG. 8, a stopper 32 may be provided on the ceiling portion 11b of the container body 11 so as to project outward. In this case, when the injection needle 23 is pierced into the insertion surface 13 from the outside of the container body 11, the tip of the stopper 32 comes into contact with the end of the syringe 25, thereby restricting further insertion of the injection needle 23. It is possible to prevent the tip of the injection needle 23 from breaking through the heat-sealed portion 18 of the container body 11.

また、前述の実施の形態では、容器本体11の他側の開口14が、当該他側の開口14を構成する壁面11a同士が密着された状態で密封可能であったが、これに限定されず、例えば容器本体11の他側の開口14にキャップが嵌合されることで密封可能であってもよい。この場合、注射剤入り容器の製造業者側において、たとえばヒートシール用の特殊な設備を用意することが不要であり、負担が少なくなる。 Further, in the above-described embodiment, the opening 14 on the other side of the container body 11 can be sealed in a state where the wall surfaces 11a constituting the opening 14 on the other side are in close contact with each other, but the present invention is not limited to this. For example, the container body 11 may be hermetically sealed by fitting a cap into the opening 14 on the other side. In this case, it is not necessary for the manufacturer of the container containing the injection to prepare special equipment for heat sealing, for example, and the burden is reduced.

また、前述の実施の形態では、容器本体11と保護カバー12とが連結部15および第2連結部16により連結されていたが、これに限定されず、第2連結部16が省略されて容器本体11と保護カバー12とが連結部15だけで連結されていてもよい。この場合、挿入面13を露出させる際に保護カバー12が容器本体11から分離されるため、図6に示すように、下向きに向けられた挿入面13に注射針23を突き刺す時に、保護カバー12が容器本体11から垂れ下がって注射針23と干渉することが防止される。また、連結部15は、円周方向に間隔を空けて複数設けられていてもよいし、円周方向に沿ってリング状に設けられていてもよい。円周方向に沿ってリング状に設けられていれば、挿入面13の衛生性をより確実に維持することができる。 Further, in the above-described embodiment, the container body 11 and the protective cover 12 are connected by the connecting portion 15 and the second connecting portion 16, but the present invention is not limited to this, and the second connecting portion 16 is omitted to form the container. The main body 11 and the protective cover 12 may be connected only by the connecting portion 15. In this case, since the protective cover 12 is separated from the container body 11 when the insertion surface 13 is exposed, the protective cover 12 is inserted when the injection needle 23 is pierced into the downwardly facing insertion surface 13 as shown in FIG. Is prevented from hanging from the container body 11 and interfering with the injection needle 23. Further, a plurality of connecting portions 15 may be provided at intervals in the circumferential direction, or may be provided in a ring shape along the circumferential direction. If the insertion surface 13 is provided in a ring shape along the circumferential direction, the hygiene of the insertion surface 13 can be more reliably maintained.

10 注射剤収納用容器
11 容器本体
11a 開口を構成する壁面
11b 天井部
12 保護カバー
12a 鍔部
13 挿入面
14 開口
15 連結部
16 第2連結部
17 傾斜部
18 ヒートシールされた部分
20 注射剤入り容器
21 注射剤
22 注射器
23 注射針
24 ピストン
25 シリンジ
31 補強リブ
32 ストッパ
10 Syringe storage container 11 Container body 11a Wall surface 11b that constitutes the opening Ceiling part 12 Protective cover 12a Flange part 13 Insertion surface 14 Opening 15 Connecting part 16 Second connecting part 17 Inclined part 18 Heat-sealed part 20 Contains injection Container 21 Injection 22 Syringe 23 Injection needle 24 Piston 25 Syringe 31 Reinforcing rib 32 Stopper

Claims (1)

一側に注射針の挿入面を有し、他側が開口する容器本体と、
前記容器本体の前記挿入面を覆う保護カバーと、
前記保護カバーと前記容器本体とを連結する連結部と、
を備え、
前記挿入面は、注射針が貫通可能であり、
前記他側の開口は、密封可能であり、
前記連結部は、前記挿入面が露出するように前記保護カバーが外される際に破壊されることを特徴とする注射剤収納用容器。
A container body that has an injection needle insertion surface on one side and opens on the other side,
A protective cover that covers the insertion surface of the container body,
A connecting portion that connects the protective cover and the container body,
With
The insertion surface is piercable by an injection needle.
The opening on the other side can be sealed and
The connecting portion is a container for storing an injection, which is broken when the protective cover is removed so that the insertion surface is exposed.
JP2020217737A 2019-06-05 2020-12-25 A container for storing an injection, a container containing an injection, a method of using a container containing an injection, and a method for containing an injection in a container for containing an injection Active JP7293185B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2020217737A JP7293185B2 (en) 2019-06-05 2020-12-25 A container for storing an injection, a container containing an injection, a method of using a container containing an injection, and a method for containing an injection in a container for containing an injection
JP2023034541A JP2023060223A (en) 2019-06-05 2023-03-07 Injection preparation storing container, injection preparation-filled container, method for using injection preparation-filled container and method for storing injection preparation in injection preparation storing container

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61159933U (en) * 1985-03-28 1986-10-03
JPH0245056A (en) * 1988-06-01 1990-02-15 Stella Kg Werner Deussen Ampule
JP2012106763A (en) * 2010-11-17 2012-06-07 Daikyo Seiko Ltd Plastic cap, and method of manufacturing the same
KR20140022340A (en) * 2012-08-14 2014-02-24 이상운 Plastic ampoule molded by injection

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61159933U (en) * 1985-03-28 1986-10-03
JPH0245056A (en) * 1988-06-01 1990-02-15 Stella Kg Werner Deussen Ampule
JP2012106763A (en) * 2010-11-17 2012-06-07 Daikyo Seiko Ltd Plastic cap, and method of manufacturing the same
KR20140022340A (en) * 2012-08-14 2014-02-24 이상운 Plastic ampoule molded by injection

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