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JP7520399B2 - Shielding containers for radiopharmaceuticals - Google Patents

Shielding containers for radiopharmaceuticals Download PDF

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Publication number
JP7520399B2
JP7520399B2 JP2022168630A JP2022168630A JP7520399B2 JP 7520399 B2 JP7520399 B2 JP 7520399B2 JP 2022168630 A JP2022168630 A JP 2022168630A JP 2022168630 A JP2022168630 A JP 2022168630A JP 7520399 B2 JP7520399 B2 JP 7520399B2
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radiation
shielding
shielding material
lid
bottomed cylindrical
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JP2023002704A (en
JP2023002704A5 (en
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真一 野口
悠矢 藤井
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Pdrファーマ株式会社
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Description

本発明は、放射性医薬品の輸送や保管の際に、放射性医薬品から放出される放射線による人体への被曝を防止するために用いられる放射性医薬品用遮蔽容器に関する。 The present invention relates to a shielding container for radiopharmaceuticals that is used to prevent exposure of the human body to radiation emitted from radiopharmaceuticals during transportation and storage of the radiopharmaceuticals.

放射性医薬品としては、一般にバイアル入り注射液や薬液充填済みシリンジが汎用されており、これらは放射線による人体への被曝防止のため放射線遮蔽容器に収納して輸送や保管されている。
斯かる放射線遮蔽容器としては、放射線遮蔽材を備えた容器本体と、放射線遮蔽材を備えた蓋体から構成されたものが既に知られている(例えば特許文献1参照)。
Radioactive pharmaceuticals are generally used in the form of injections in vials or syringes prefilled with the drug solution, and these are transported and stored in radiation-shielding containers to prevent human exposure to radiation.
As such a radiation-shielding container, one that is composed of a container body provided with a radiation-shielding material and a lid body also provided with a radiation-shielding material is already known (see, for example, Patent Document 1).

然るとき、斯かる従来の放射線遮蔽容器は、高価な放射線遮蔽材を蓋体の下方から分別取り出してリユースするために、放射線遮蔽材を蓋体の内部に吊り下げた状態で保持していた。そのため重量物である放射線遮蔽材が放射性医薬品の使用中に蓋体から外れて落下し、作業者のケガにつながる恐れがあった。他方、その落下を防止すべく放射線遮蔽材の吊り下げ状態を強固なものとすると、リユースのための分別取り出しが困難になると云う問題があった。 However, such conventional radiation shielding containers hold the expensive radiation shielding material in a suspended state inside the lid so that it can be removed separately from under the lid for reuse. This means that the heavy radiation shielding material can come off the lid and fall during use of the radiopharmaceutical, which can lead to injury to workers. On the other hand, if the radiation shielding material is hung firmly to prevent it from falling, there is the problem that it becomes difficult to remove it separately for reuse.

特開2005-315577号公報JP 2005-315577 A

本発明は、上記の如き従来の問題に鑑みてなされたものであり、放射線遮蔽材が蓋体から落下する恐れがなく、しかもリユースのための放射線遮蔽材の分別取り出しを極めて容易に行なうことができる蓋体を備えた放射性医薬品用遮蔽容器を提供することを課題としている。 The present invention was made in consideration of the above-mentioned problems of the prior art, and aims to provide a shielding container for radioactive pharmaceuticals with a lid that eliminates the risk of radiation shielding material falling out of the lid and makes it extremely easy to separate and remove the radiation shielding material for reuse.

本発明者は、上記の課題を解決すべく鋭意研究を重ねた結果、放射線遮蔽材を蓋体内部に吊り下げず、有底筒状体に収納して蓋体とすれば、極めて良い結果が得られることを見い出し、本発明を完成した。 As a result of extensive research into solving the above problems, the inventors discovered that extremely good results could be obtained by storing the radiation shielding material in a bottomed cylindrical body as the lid, rather than suspending it inside the lid, and thus completed the present invention.

すなわち、本発明は、有底筒状体に放射線遮蔽材が収納され、かつ当該有底筒状体の開口部が閉止部材で着脱自在に閉止された放射線遮蔽蓋体が、当該有底筒状体の底部側において放射線遮蔽容器本体に着脱自在に取り付けられていることを特徴とする放射性医薬品用遮蔽容器により解決したものである。 That is, the present invention solves the problem by providing a shielding container for radioactive pharmaceuticals, characterized in that a radiation shielding material is stored in a bottomed cylindrical body, and a radiation shielding lid, the opening of which is detachably closed by a closing member, is detachably attached to the radiation shielding container body on the bottom side of the bottomed cylindrical body.

本発明の放射性医薬品用遮蔽容器によれば、蓋体の放射線遮蔽材が有底筒状体に収納されているので、それが、放射性医薬品の使用中に落下する恐れは全くない。しかも、上部の蓋部材を取り外すだけで有底筒状体の上部開口部から放射線遮蔽材のみを極めて容易に取り出すことができる。 According to the radiopharmaceutical shielding container of the present invention, the radiation shielding material of the lid body is stored in the bottomed cylindrical body, so there is absolutely no risk of it falling off during use of the radiopharmaceutical. Moreover, by simply removing the top lid member, it is extremely easy to remove just the radiation shielding material from the top opening of the bottomed cylindrical body.

本発明放射性医薬品用遮蔽容器の縦断面説明図。FIG. 2 is a longitudinal sectional view of a shielding container for radioactive pharmaceuticals according to the present invention. 本発明で用いる閉止部材例を示す縦断面説明図。FIG. 4 is a longitudinal sectional view showing an example of a closing member used in the present invention. 本発明で用いる閉止部材例を示す平面説明図。FIG. 4 is an explanatory plan view showing an example of a closing member used in the present invention. 本発明の放射線遮蔽容器本体の底面説明図。FIG. 2 is an explanatory bottom view of the radiation shielding container body of the present invention.

以下、本発明の実施の形態を図面と共に説明する。 The following describes an embodiment of the present invention with reference to the drawings.

図1において、10は放射線遮蔽蓋体で、上部に開口部11aを有すると共に、下部が底部11bで閉塞された有底筒状体11の内部に略円盤状の放射線遮蔽材12が収納されている。 In FIG. 1, 10 is a radiation shielding cover, which has an opening 11a at the top and a bottom-closed cylindrical body 11 with a bottom 11b at the bottom, and contains a substantially disk-shaped radiation shielding material 12 inside.

ここに収納は、有底筒状体11への放射線遮蔽材12の単なる挿置であっても良いが、当該放射線遮蔽材12の下部に形成した突出部を有底筒状体11の底部11bに形成した凹所に挿入嵌合して収納するのが、当該放射線遮蔽材12の有底筒状体11内における横方向の動きを抑止し、安定に保持固定する上で望ましい。より具体的には、図1に示したように、放射線遮蔽材12の下面外縁部に、内側から外側方向に下降傾斜するテーパー内面12bを有する筒状突出部12aを形成すると共に、有底筒状体11の底部11b外縁部に当該筒状突出部12aの外形に対応するテーパー付きの環状凹所11cを形成して、当該環状凹所11cに筒状突出部12aを挿入嵌合するのが、放射線遮蔽材12の動き抑止はもとより、嵌合操作性とその離脱操作性にも優れ、特に有利である。尚、当該筒状突出部12aの内面の下降傾斜角度としては、放射線遮蔽材12の下面を基準に95°~175°であればよいが、100°~135°が好ましく、100°~115°が特に好ましい。 Although the radiation shielding material 12 may be simply inserted into the bottomed cylindrical body 11, it is preferable to insert and fit a protrusion formed on the lower part of the radiation shielding material 12 into a recess formed in the bottom 11b of the bottomed cylindrical body 11 to store the radiation shielding material 12 in order to prevent lateral movement of the radiation shielding material 12 in the bottomed cylindrical body 11 and stably hold and fix the radiation shielding material 12. More specifically, as shown in Fig. 1, a cylindrical protrusion 12a having a tapered inner surface 12b that slopes downward from the inside to the outside is formed on the outer edge of the lower surface of the radiation shielding material 12, and a tapered annular recess 11c corresponding to the outer shape of the cylindrical protrusion 12a is formed on the outer edge of the bottom 11b of the bottomed cylindrical body 11, and the cylindrical protrusion 12a is inserted and fitted into the annular recess 11c, which is particularly advantageous in that it not only prevents the radiation shielding material 12 from moving, but also provides excellent fitting and removal operability. The downward inclination angle of the inner surface of the cylindrical protrusion 12a may be 95° to 175° with respect to the bottom surface of the radiation shielding material 12, but 100° to 135° is preferable, and 100° to 115° is particularly preferable.

また、当該放射線遮蔽材12は、有底筒状体11の底部11bとの間に空域部13を設けて収納するのが、後述する放射線遮蔽容器本体20に収納されるバイアル30等の医薬品が当該底部11bに当った際に、その衝撃を軽減する上で望ましい。この場合、空域部13の大きさとしては、上下の間隔が3.0~10.0mmで、バイアル蓋30a等の収納する医薬品の上部径よりも大きな径とするのが好ましい。また、当該空域部13の形成手段は、スペーサーの介在等特に限定されないが、放射線遮蔽材12の下面部に適宜凹所を設けて形成するのが簡便である。
尚、有底筒状体11の材質としては、ポリプロピレンやポリエチレン等のプラスチックが好ましいものとして挙げられ、放射線遮蔽材12の材質としては、鉛、タングステンが好ましいものとして挙げられる。
In addition, it is preferable to provide an air space 13 between the radiation shielding material 12 and the bottom 11b of the bottomed cylindrical body 11 in order to reduce the impact when a medicine such as a vial 30 stored in the radiation shielding container body 20 described later hits the bottom 11b. In this case, the size of the air space 13 is preferably such that the vertical gap is 3.0 to 10.0 mm and the diameter is larger than the upper diameter of the medicine stored in the vial cap 30a, etc. In addition, the means for forming the air space 13 is not particularly limited, such as the interposition of a spacer, but it is simple to form the air space 13 by providing an appropriate recess in the lower surface of the radiation shielding material 12.
The material of the bottomed cylindrical body 11 is preferably a plastic such as polypropylene or polyethylene, and the material of the radiation shielding material 12 is preferably lead or tungsten.

14は円板状の閉止部材で、有底筒状体11の開口部11aを着脱自在に閉止すると共に、放射線遮蔽材12を上方から圧接固定している。この閉止部材14により、放射線遮蔽材12の外方への飛び出しが防止される。また、この閉止部材14を、不透明体とすることにより、放射線遮蔽材12が外部から見えることを防止し得るので、きれいな外観の蓋体10を提供することができる。この閉止部材14の着脱方式は特に限定されないが、有底筒状体11の開口部11aへの落し蓋的な内挿嵌合方式が簡便である。この場合、閉止部材14の端縁部に着脱操作用のつまみ突片14aを付設するのが好ましい。
尚、閉止部材14の材質としては、ポリプロピレンやポリエチレン等のプラスチックが好ましいものとして挙げられる。
Reference numeral 14 denotes a disk-shaped closing member which detachably closes the opening 11a of the bottomed cylindrical body 11 and presses and fixes the radiation-shielding material 12 from above. This closing member 14 prevents the radiation-shielding material 12 from jumping outward. By making the closing member 14 opaque, the radiation-shielding material 12 can be prevented from being seen from the outside, providing the lid 10 with a clean appearance. There are no particular limitations on the method of attaching and detaching the closing member 14, but a simple method is to insert and fit the opening 11a of the bottomed cylindrical body 11 like a drop lid. In this case, it is preferable to provide a knob protrusion 14a for attachment and detachment at the edge of the closing member 14.
As the material for the closing member 14, a plastic such as polypropylene or polyethylene is preferable.

15はキャップ部で、円板状本体部15aとその外周部下方に突出連成された周壁部15bとから構成され、当該周壁部15bが、閉止部材14の上部に突出している有底筒状体11の開口部11a側壁に着脱自在に取り付けられている。このキャップ部15の取り付けにより、閉止部材14とキャップ部15の間に添付文書17等収納用の空域部16が形成されると共に、放射線遮蔽材12の外方への飛び出し防止が、閉止部材14と相俟って強化される。この放射線遮蔽材12の外方飛び出しをより確実にするために、当該周壁部15bの当該開口部11aへの着脱自在の取り付けは螺合とするのが望ましい。また、この螺合での取り付けと合わせてあるいは別に、放射線遮蔽材12の外方飛び出しをより確実にするために、閉止部材14の上面部に、図2及び図3で示したように、キャップ部15下面部に当接する突起14bを適宜数配設するのも望ましい。キャップ部15下面部に突起14bが当接することで、実質的に閉止部材14とキャップ部15が一体となり、閉止部材14の有底筒状体11の開口部11aへの取り付けと当該周壁部15bの当該開口部11aへの取り付けの2つの取り付け機構により放射線遮蔽材12を圧接固定するからである。この場合、当該突起14bの高さ(換言すれば空域部16の上下間隔)は、5.0~10.0mmとするのが好ましい。
尚、キャップ部15の材質としては、ポリプロピレンやポリエチレン等のプラスチック
が好ましいものとして挙げられるが、特に透明材質のものを用いれば、空域部16内の添付文書の有無を外部からチェックできるのでより望ましい。
Reference numeral 15 denotes a cap portion, which is composed of a disk-shaped main body portion 15a and a peripheral wall portion 15b connected to the disk-shaped main body portion 15a and protruding downward from its outer periphery, and the peripheral wall portion 15b is detachably attached to the side wall of the opening 11a of the bottomed cylindrical body 11 protruding above the closing member 14. By attaching the cap portion 15, an air space 16 for storing the package insert 17 and the like is formed between the closing member 14 and the cap portion 15, and the prevention of the radiation shielding material 12 from jumping outward is strengthened in cooperation with the closing member 14. In order to more reliably prevent the radiation shielding material 12 from jumping outward, it is preferable to detachably attach the peripheral wall portion 15b to the opening 11a by screwing. In addition to or in addition to the screwing attachment, it is also preferable to provide an appropriate number of protrusions 14b that come into contact with the lower surface portion of the cap portion 15 on the upper surface of the closing member 14, as shown in Figs. 2 and 3, in order to more reliably prevent the radiation shielding material 12 from jumping outward. This is because the protrusion 14b comes into contact with the lower surface of the cap portion 15, so that the closing member 14 and the cap portion 15 are substantially integrated, and the radiation shielding material 12 is pressed and fixed by two attachment mechanisms, namely, attachment of the closing member 14 to the opening 11a of the bottomed cylindrical body 11 and attachment of the peripheral wall portion 15b to the opening 11a. In this case, the height of the protrusion 14b (in other words, the vertical distance of the airspace portion 16) is preferably 5.0 to 10.0 mm.
As the material for the cap portion 15, plastics such as polypropylene and polyethylene are preferred, and it is particularly preferable to use a transparent material, since it is possible to check from the outside whether or not there is an attached document in the air space 16.

20は放射線遮蔽容器本体で、有底筒状体21の内部に放射線遮蔽材22が収納されている。この放射線遮蔽材22にはバイアル30等の医薬品収納用凹所23が形成されていると共に、当該医薬品収納用凹所23の略上半分の内壁部には、バイアル30等の医薬品を保持固定するプラスチック製の内装材24が挿置されている。
当該有底筒状体21の側面部には、本発明遮蔽容器をシュリンク包装した場合に、フィルムの回り動きを防止するために、図1及び図4に示すような突状部21aを形成するのが好ましい。
尚、当該有底筒状体21と放射線遮蔽材22の材質は、それぞれ蓋体10の有底筒状体11並びに放射線遮蔽材12と同様な材質が使用される。
Reference numeral 20 denotes a radiation-shielding container body, which contains a radiation-shielding material 22 housed inside a bottomed cylindrical body 21. A recess 23 for storing medicines such as vials 30 is formed in this radiation-shielding material 22, and a plastic interior material 24 for holding and fixing medicines such as vials 30 is inserted into the inner wall of approximately the upper half of the recess 23 for storing medicines.
It is preferable to form a protrusion 21a on the side surface of the bottomed cylindrical body 21 as shown in Figs. 1 and 4 in order to prevent the film from moving around when the shielding container of the present invention is shrink-packaged.
The materials used for the bottomed cylindrical body 21 and the radiation shielding material 22 are the same as those used for the bottomed cylindrical body 11 and the radiation shielding material 12 of the lid 10, respectively.

当該放射線遮蔽容器本体20の上部開口部に、上記の放射線遮蔽蓋体10が、その有底筒状体11の底部11b側において着脱自在に取り付けられている。この蓋体10の容器本体20への着脱自在の取り付けは、収納された放射性医薬品の飛び出しを防止するために螺合方式が望ましい。この場合、蓋体10の有底筒状体11の外周壁を底部11bより下方に延設し、当該延設外周壁内側と容器本体20の上部外周壁外側において螺合せしめるのが簡便である。 The radiation-shielding lid 10 is removably attached to the top opening of the radiation-shielding container body 20 at the bottom 11b side of the bottomed cylindrical body 11. The lid 10 is preferably removably attached to the container body 20 by a screwing method to prevent the stored radiopharmaceutical from spilling out. In this case, it is simple to extend the outer peripheral wall of the bottomed cylindrical body 11 of the lid 10 downward from the bottom 11b and screw the inside of the extended outer peripheral wall to the outside of the upper outer peripheral wall of the container body 20.

10:放射線遮蔽蓋体
11:有底筒状体
11a:開口部
11b:底部
11c:環状凹所
12:放射線遮蔽材
12a:筒状突出部
12b:テーパー内面
13:空域部
14:閉止部材
14a:つまみ突片
14b:突起
15:キャップ部
15a:円板状本体部
15b:周壁部
16:空域部
17:添付文書
20:放射線遮蔽容器本体
21:有底筒状体
21a:突状部
22:放射線遮蔽材
23:医薬品収納用凹所
24:内装材
30:バイアル
30a:バイアル蓋
10: Radiation shielding lid 11: Bottomed cylindrical body 11a: Opening 11b: Bottom 11c: Annular recess 12: Radiation shielding material 12a: Cylindrical protrusion 12b: Tapered inner surface 13: Air space 14: Closing member 14a: Knob protrusion 14b: Protrusion 15: Cap portion 15a: Disc-shaped main body 15b: Peripheral wall 16: Air space 17: Package insert 20: Radiation shielding container main body 21: Bottomed cylindrical body 21a: Protrusion 22: Radiation shielding material 23: Medicine storage recess 24: Interior material 30: Vial 30a: Vial lid

Claims (5)

略円盤状の放射線遮蔽材が内部に収納された放射線遮蔽蓋体が、医薬品バイアルを内部に収納する放射線遮蔽容器本体に着脱自在に取り付けられている放射性医薬品用遮蔽容器であって、
前記放射線遮蔽材が、前記医薬品バイアルが接し得る前記放射線遮蔽蓋体の接触面との間に空域部を設けて収納され
前記空域部が、前記医薬品バイアルの上部径より大きな径であることを特徴とする放射性医薬品用遮蔽容器。
A radiopharmaceutical shielding container in which a radiation-shielding lid body having a substantially disk-shaped radiation-shielding material stored therein is detachably attached to a radiation-shielding container body that stores a pharmaceutical vial therein,
The radiation-shielding material is stored with an air space provided between the radiation-shielding cover and a contact surface of the radiation-shielding cover with which the pharmaceutical vial can come into contact ;
A shielding container for radioactive pharmaceuticals , wherein the airspace has a diameter larger than the upper diameter of the pharmaceutical vial .
略円盤状の放射線遮蔽材が内部に収納された放射線遮蔽蓋体が、医薬品バイアルを内部に収納する放射線遮蔽容器本体に着脱自在に取り付けられている放射性医薬品用遮蔽容器であって、
前記放射線遮蔽蓋体の内部に空域部が設けられ、
前記空域部は、前記医薬品バイアルが前記放射線遮蔽蓋体に当った際の衝撃を軽減するためのものであることを特徴とする放射性医薬品用遮蔽容器。
A radiopharmaceutical shielding container in which a radiation-shielding lid body having a substantially disk-shaped radiation-shielding material stored therein is detachably attached to a radiation-shielding container body that stores a pharmaceutical vial therein,
An air space is provided inside the radiation shielding cover,
A shielding container for radioactive pharmaceuticals, characterized in that the air space is intended to reduce impact when the pharmaceutical vial hits the radiation-shielding lid.
前記空域部が、前記医薬品バイアルの上部径より大きな径であることを特徴とする請求項記載の放射性医薬品用遮蔽容器。 3. The radiopharmaceutical shielding container according to claim 2 , wherein the airspace has a diameter larger than the diameter of the upper portion of the pharmaceutical vial . 前記空域部が、前記放射線遮蔽材の下面部に凹所を形成して設けられていることを特徴とする請求項1~3のいずれか1項記載の放射性医薬品用遮蔽容器。 The radiopharmaceutical shielding container according to any one of claims 1 to 3, characterized in that the airspace is provided by forming a recess in the lower surface of the radiation shielding material. 前記放射線遮蔽蓋体が、上部に閉止部材で着脱自在に閉止された開口部を有すると共に、下部が底部で閉塞された有底筒状体であって、前記有底筒状体下部の底部側において前記放射線遮蔽容器本体に着脱自在に取り付けられていることを特徴とする請求項1~4のいずれか1項記載の放射性医薬品用遮蔽容器。 The shielding container for radiopharmaceuticals according to any one of claims 1 to 4, characterized in that the radiation shielding lid has an opening at the top that is detachably closed by a closing member, and is a bottomed cylindrical body whose lower part is closed at the bottom, and is detachably attached to the radiation shielding container body at the bottom side of the bottomed cylindrical body.
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Citations (2)

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JP2005315577A (en) 2004-04-26 2005-11-10 Daiichi Radioisotope Labs Ltd Container for medicine
US20070129591A1 (en) 2005-12-07 2007-06-07 Vulcan Lead, Inc. Radiation-shielding container

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JP3789811B2 (en) * 2001-12-14 2006-06-28 株式会社セブン・セブン Cold storage container for medicine
JP4469189B2 (en) * 2004-02-12 2010-05-26 日本メジフィジックス株式会社 Radiopharmaceutical transport container

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
JP2005315577A (en) 2004-04-26 2005-11-10 Daiichi Radioisotope Labs Ltd Container for medicine
US20070129591A1 (en) 2005-12-07 2007-06-07 Vulcan Lead, Inc. Radiation-shielding container

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