JP5746552B2

JP5746552B2 - Vial shield

Info

Publication number: JP5746552B2
Application number: JP2011101907A
Authority: JP
Inventors: 雅人大屋; 拓二古荘; 仁史森本; 直人関谷
Original assignee: Nihon Medi Physics Co Ltd
Current assignee: Nihon Medi Physics Co Ltd
Priority date: 2010-04-30
Filing date: 2011-04-28
Publication date: 2015-07-08
Anticipated expiration: 2031-04-28
Also published as: JP2011247885A

Description

本発明は、放射性核種溶出装置における溶出液流出ニードルに接続して溶出液を採取するバイアルや放射性医薬品の調製を行うためのバイアルに使用する放射線遮へい容器（以下、バイアルシールド）に関する。 The present invention relates to a radiation shielding container (hereinafter referred to as a vial shield) used for a vial for collecting an eluate by connecting to an eluate outflow needle in a radionuclide elution apparatus and a vial for preparing a radiopharmaceutical.

過テクネチウム酸ナトリウム注射液等の放射性医薬品を医療現場で製造する際に用いられる放射性核種溶出装置として、図６に示すものが知られている。図６において、１０２はプラスチック製本体ケース、１０４は本体ケース１０２に着脱可能に取り付けられて本体ケース１０２の上端開口部を閉塞するプラスチック製蓋体を示す。蓋体１０４には、生理食塩液バイアル挿入凹部１０６及び無菌減圧バイアル挿入凹部１０８が形成されている。また、図中１１０は本体ケース１０２内に配設された放射性核種溶出カラム、１１２は生理食塩液流通管（溶離液流入管）、１１４は溶出液流通管（溶離液流出管）を示す。生理食塩液流通管１１２は、蓋体１０４の生理食塩液バイアル挿入凹部１０６の底部に突出した生理食塩液流入ニードル（溶離液流入ニードル）１１６を一端側に有し、他端側が放射性核種溶出カラム１１０に接続されたものである。溶出液流通管１１４は、蓋体１０４の無菌減圧バイアル挿入凹部１０８の底部に突出した溶出液流出ニードル１１８を一端側に有し、他端側が放射性核種溶出カラム１１０に接続されたものである。なお、本体ケース１０２内のカラム１１０の周囲には、放射線遮へい金属としてカラム収納部を有する鉛、タングステンあるいはそれらを組み合わせた遮へい部材(図示せず)が装填され、無菌減圧バイアル１２２は放射線遮へい材料で周囲が覆われたバイアルシールド１２４で遮へいされている。 As a radionuclide elution apparatus used when manufacturing a radiopharmaceutical such as sodium pertechnetate injection at a medical site, the one shown in FIG. 6 is known. In FIG. 6, reference numeral 102 denotes a plastic main body case, and reference numeral 104 denotes a plastic lid body that is detachably attached to the main body case 102 and closes the upper end opening of the main body case 102. The lid 104 is formed with a physiological saline vial insertion recess 106 and a sterile decompression vial insertion recess 108. In the figure, reference numeral 110 denotes a radionuclide elution column disposed in the main body case 102, 112 denotes a physiological saline flow pipe (eluent inflow pipe), and 114 denotes an eluate flow pipe (eluent outflow pipe). The physiological saline flow pipe 112 has a physiological saline inflow needle (eluent inflow needle) 116 protruding from the bottom of the physiological saline vial insertion recess 106 of the lid 104 at one end, and the radionuclide elution column at the other end. 110 is connected. The eluate circulation pipe 114 has an eluate outflow needle 118 protruding from the bottom of the sterile decompression vial insertion recess 108 of the lid 104 at one end and the other end connected to the radionuclide elution column 110. In addition, the periphery of the column 110 in the main body case 102 is loaded with a shielding member (not shown) including lead, tungsten, or a combination thereof having a column housing portion as a radiation shielding metal, and the sterile vacuum vial 122 is made of a radiation shielding material. It is shielded by a vial shield 124 whose periphery is covered with.

図６に示した放射性核種溶出装置１００を用いて放射性医薬品を調製する場合、生理食塩液バイアル挿入凹部１０６に生理食塩液バイアル１２０を挿入した後、無菌減圧バイアル挿入凹部１０８にバイアルシールド１２４内に収容された無菌減圧バイアル１２２を挿入する。すると、無菌減圧バイアル１２２内は減圧されているため、生理食塩液バイアル１２０中の生理食塩液は生理食塩液流入ニードル１１６から吸引され、生理食塩液流通管１１２を通ってカラム１１０内に入り、カラム１１０内で生理食塩液に放射性核種が溶出される。その後、カラム１１０を流出した溶出液は溶出液流通管１１４を通って溶出液流出ニードル１１８から無菌減圧バイアル１２２内に入る。無菌調製バイアルは放射線遮へい金属で周囲が遮へいされているので、このまま次の操作に使用することができる。例えば、得られた放射性核種は無菌バイアル内で薬学的に許容される試薬と混合する等により放射性医薬品に調製された後注射器に移されて投与される。或いは無菌バイアルから注射器で放射性核種を抜き取り、薬学的に許容される試薬の入った別のバイアルに移して混合することにより放射性医薬品が得られる。 In the case of preparing a radiopharmaceutical using the radionuclide elution apparatus 100 shown in FIG. 6, after the physiological saline vial 120 is inserted into the physiological saline vial insertion recess 106, the sterile vacuum vial insertion recess 108 is inserted into the vial shield 124. Insert the contained sterile vacuum vial 122. Then, since the inside of the sterile vacuum vial 122 is depressurized, the physiological saline in the physiological saline vial 120 is sucked from the physiological saline inflow needle 116, enters the column 110 through the physiological saline flow pipe 112, The radionuclide is eluted in the physiological saline in the column 110. Thereafter, the eluate flowing out of the column 110 passes through the eluent flow pipe 114 and enters the sterile vacuum vial 122 from the eluate outflow needle 118. The aseptic preparation vial is shielded by a radiation shielding metal, so that it can be used for the next operation as it is. For example, the obtained radionuclide is prepared into a radiopharmaceutical by mixing with a pharmaceutically acceptable reagent in a sterile vial, and then transferred to a syringe for administration. Alternatively, a radiopharmaceutical is obtained by extracting the radionuclide from a sterile vial with a syringe, transferring it to another vial containing a pharmaceutically acceptable reagent, and mixing.

放射性核種による被ばくから術者を守るため、放射性核種溶出装置から溶出液を取り出すためのバイアルや、放射性核種を注射器から移して調製する際に使用するバイアルは放射線遮へい金属を使用したバイアルシールドで覆われている。バイアルシールドで覆われたバイアルを用いて放射性医薬品を調合する場合には、バイアルシールドの上部に設けられた開口を通してバイアルの上部のゴム栓から試薬等が注射器によりバイアルに注入される。また、バイアル内の液を注射器に移す場合には、バイアルをバイアルシールドごと逆さにしてゴム栓を注射針で貫通し、針先が放射性医薬品を吸引できる状態になっていることを確認しながら注射器本体内に吸引する操作が行われる。 To protect the operator from exposure to radionuclides, vials for removing eluate from the radionuclide elution device and vials used for preparation by transferring radionuclides from syringes should be covered with a vial shield using a radiation shielding metal. It has been broken. When a radiopharmaceutical is prepared using a vial covered with a vial shield, a reagent or the like is injected into the vial by a syringe from a rubber stopper at the top of the vial through an opening provided at the top of the vial shield. When transferring the liquid in the vial to the syringe, invert the vial together with the vial shield, penetrate the rubber stopper with the injection needle, and confirm that the needle tip is in a state capable of sucking the radiopharmaceutical. An operation of sucking into the body is performed.

バイアルシールドは放射線被ばくから術者を守ると共に上記の操作に支障が無いよう使いやすいものが望まれる。従来使用されているバイアルシールドの例を図７、図８に示す。図７のバイアルシールド２００は全体がプラスチックでできた本体ケース２０１で覆われていて、内部には鉛遮へい部と図９に示すようなバイアル９０を収容するための空間が設けられている。バイアルシールドの上部及び下部には鉛をプラスチックで覆った上蓋２０３及び底蓋２０４が設けられていて、上蓋２０３には溶出液流出ニードルや注射器の針をバイアルに通すための開口部２０２が設けられている。また、上蓋２０３を開閉することにより、バイアル瓶をバイアルシールド内に収容することを可能にしている。鉛遮へい部は側面の一部が突出しており、ここに透明放射線遮へい材料である鉛ガラスが嵌めこまれた窓部２０５が形成されている。術者はこの窓を通して、放射性核種溶出装置の溶出液がバイアルに流入する様子やバイアルから液を抜く場合液面の位置等を知る。 A vial shield is desired that protects the operator from radiation exposure and is easy to use so as not to interfere with the above operation. Examples of conventionally used vial shields are shown in FIGS. The vial shield 200 in FIG. 7 is entirely covered with a main body case 201 made of plastic, and a lead shielding portion and a space for accommodating a vial 90 as shown in FIG. 9 are provided inside. An upper lid 203 and a bottom lid 204 covered with plastic are provided at the upper and lower portions of the vial shield. The upper lid 203 is provided with an opening 202 for passing the eluate outflow needle and the needle of the syringe through the vial. ing. Further, by opening and closing the upper lid 203, the vial can be accommodated in the vial shield. A part of the side surface of the lead shielding part protrudes, and a window part 205 into which lead glass as a transparent radiation shielding material is fitted is formed. Through this window, the operator knows how the eluate of the radionuclide elution apparatus flows into the vial and the position of the liquid surface when the liquid is extracted from the vial.

図８のバイアルシールド３００は、透明プラスチックの本体ケース３０１の内部に全体が透明の鉛ガラスでできた放射線遮へい部材３０２を有している。本体ケース３０１は、両端に鉛とプラスチックで形成された上蓋３０３、下蓋３０４を有し、上蓋の開閉により、バイアルがバイアルシールド内に収容される。上蓋の中央部は溶出液流出ニードルや注射器の針をバイアルに通すための開口部３０５が設けられている。 The vial shield 300 in FIG. 8 has a radiation shielding member 302 made of transparent lead glass as a whole inside a transparent plastic main body case 301. The main body case 301 has an upper lid 303 and a lower lid 304 formed of lead and plastic at both ends, and the vial is accommodated in the vial shield by opening and closing the upper lid. The central part of the upper lid is provided with an opening 305 for passing the eluate outflow needle and the needle of the syringe through the vial.

図７のバイアルシールドは、鉛ガラスが嵌めこまれたところ以外、光を通さない金属鉛で覆われている。このため、内部が比較的暗く、前述した放射性核種溶出装置からバイアル内に溶出液が流出する様子や、バイアルから液を抜き取る際に注射針を視認するのも容易ではなく、特にバイアルから放射性医薬品を抜き取るには熟練した操作を必要とした。
また、図８のバイアルシールドは、鉛ガラスが多用されているため、内部に光が入りやすく使いやすさは大いに改良されたものの、使用されている鉛ガラスは金属鉛と比較して遮へい能力が低く、それ自体極めて高価であり、また内部の視認性を高めるため、内表面、外表面の両表面を極めて平滑になるまで磨く必要があること、さらに鉛ガラスは極めて壊れやすいため複雑な形状に加工することが困難であることからコストがかかる点が問題であった。さらに、プラスチック製の本体ケースで覆われてはいるものの、周囲にあるものとぶつけると鉛ガラスは簡単に割れ、或いはひびが入ってしまう。さらに鉛ガラスには湿度の影響により変色してしまう問題もある。このように問題の多い鉛ガラスの一部が変色したり、欠けたりしただけで全体を交換しなければならないことも、問題となっていた。 The vial shield of FIG. 7 is covered with metallic lead that does not transmit light except where lead glass is fitted. For this reason, the inside is relatively dark, and it is not easy for the eluate to flow into the vial from the radionuclide elution device described above, and it is not easy to visually check the injection needle when extracting the liquid from the vial. It took a skillful operation to extract.
The vial shield shown in FIG. 8 uses a lot of lead glass, so it is easy for light to enter inside and the ease of use is greatly improved. However, the lead glass used has a shielding ability compared to metallic lead. Low, it is very expensive in itself, and it is necessary to polish both the inner and outer surfaces to be very smooth to improve internal visibility, and lead glass is very fragile and has a complicated shape. The problem is that it is difficult to process and costs. Furthermore, although it is covered with a plastic body case, the lead glass can be easily broken or cracked when it hits the surrounding objects. Furthermore, lead glass also has a problem of discoloration due to the influence of humidity. Thus, it has been a problem that the lead glass, which has many problems, has to be replaced only when it is discolored or chipped.

以上の通り、これまでのバイアルシールドは安価に供給しようとして鉛を多用すれば内部が暗くなって操作に熟練を要することとなり、内部を明るくしようとして鉛ガラスを多用すると壊れやすく、交換する場合には高価になってしまうという問題を有していた。 As mentioned above, the conventional vial shield will be dark if the lead is used to supply cheaply and the operation will be dark, and the operation will require skill. Had the problem of becoming expensive.

以上に鑑み、本発明者らは鋭意研究を重ねた結果、バイアルシールドに使用する放射線遮へい部材の一部に円筒状の透明放射線遮へい材料を用い、これを交換可能にバイアルシールド内に収容することで、上記問題を解決できることを見出した。 In view of the above, as a result of intensive studies, the present inventors have used a cylindrical transparent radiation shielding material as a part of the radiation shielding member used for the vial shield, and accommodated it in the vial shield in a replaceable manner. And found that the above problem can be solved.

すなわち第一の本発明は、第一の開放端および第二の開放端を有する略円筒状の本体ケースであって、第一の開放端には内側に向かって張り出した縁状の出っ張りにより本体ケースの内径より小さく、収容するバイアルの外径より大きな口径を有する開口部が形成され、第一の開放端から軸方向に第二の開放端に向う一定高さ部分には透明材料で形成された本体ケース上部が形成され、第二の開放端側の側面の一部には本体ケースから突き出して設けられた窓枠部が形成され、窓枠部の外側の面が透明材料で形成されている本体ケースに、円筒状であって、本体ケース上部の高さとほぼ等しい高さを有し、収容するバイアルの外径以上の内径を有し、バイアル内の放射能を遮へいするのに十分な厚みを持ち、本体ケースの第一の開放端の開口部の口径より大きく、本体ケース内径よりも小さい外径を有する透明放射線遮へい材料で構成された第一放射線遮へい部材、略円筒状であって、第一放射線遮へい部材とほぼ等しい外径及び内径を有し、軸方向に一定の高さを有する放射線遮へい材料で構成された第二放射線遮へい部材であって、該第二放射線遮へい部材の側面の一部が開口部を有し、該開口部周縁から突出させた枠体であって、本体ケースの窓枠部に対応する形状を有し、該窓枠部に重なってはめ込まれるよう形成された透明放射線遮へい部材用枠部を設け、該透明放射線遮へい部材用枠部に断面が少なくとも該開口部のすべてを覆い、透明放射線遮蔽用枠部の奥行きとほぼ等しい厚みを有する透明な放射線遮へい材料で構成された放射線遮へい窓部材を配置した第二放射線遮へい部材、および外径が第二放射線遮へい部材の外径とほぼ同じで、軸方向に一定の高さを有する略円盤状の放射線遮へい材料により構成された底部放射線遮へい部材が本体ケースの第一の開放端側から順に交換可能に配置され、前記第一放射線遮へい部材の高さ、第二放射線遮へい部材の高さの合計が収容するバイアルの高さとほぼ等しく、本体ケースの第二の開放端に着脱可能に設けられる底蓋を装着することにより前記部材が本体ケース内に固定され、本体ケースの第一の開放端側には、一部または全部が放射線遮へい材料で構成された、中央に開口部を有する円盤状の放射線遮へい性上蓋が着脱可能に固定されている、内部にバイアルを収容するためのバイアルシールドである。本発明に係るバイアルシールドは、本体ケースの第一の開放端側の口径を、収容されるバイアルの外径よりも大きくしているので、上蓋を外せば、第一の開放端からバイアルの出し入れを容易に行う事が可能である。 That is, the first aspect of the present invention is a substantially cylindrical body case having a first open end and a second open end, and the main body is formed by an edge-shaped bulge projecting inward at the first open end. An opening having a smaller diameter than the inner diameter of the case and larger than the outer diameter of the vial to be accommodated is formed, and is formed of a transparent material at a constant height portion from the first open end toward the second open end in the axial direction. The upper part of the main body case is formed, a part of the side surface on the second open end side is formed with a window frame part protruding from the main body case, and the outer surface of the window frame part is formed of a transparent material. The main body case is cylindrical and has a height approximately equal to the height of the upper portion of the main body case, has an inner diameter that is equal to or greater than the outer diameter of the vial to be contained, and is sufficient to block the radioactivity in the vial. Thick and open at the first open end of the body case The first radiation shielding member is made of a transparent radiation shielding material having an outer diameter larger than the inner diameter of the main body case and smaller than the inner diameter of the main body case. The first radiation shielding member is substantially cylindrical and has an outer diameter and an inner diameter substantially equal to the first radiation shielding member. And a second radiation shielding member made of a radiation shielding material having a certain height in the axial direction, wherein a part of the side surface of the second radiation shielding member has an opening, from the periphery of the opening. Protruding frame body having a shape corresponding to the window frame portion of the main body case, provided with a transparent radiation shielding member frame portion formed so as to be overlapped with the window frame portion, and to provide the transparent radiation shielding A second radiation in which a radiation shielding window member made of a transparent radiation shielding material having a thickness substantially equal to the depth of the transparent radiation shielding frame portion is disposed in the member frame portion so that the cross section covers at least all of the openings. The shielding member and the bottom radiation shielding member made of a substantially disk-shaped radiation shielding material whose outer diameter is substantially the same as the outer diameter of the second radiation shielding member and having a certain height in the axial direction are the first of the main body case. The first radiation shielding member is arranged so as to be exchangeable in order from the open end side, and the total height of the first radiation shielding member and the second radiation shielding member is substantially equal to the height of the vial to be accommodated, and the second open end of the main body case. By attaching a detachable bottom cover, the member is fixed in the main body case, and the first open end side of the main body case is partly or entirely made of a radiation shielding material, in the center. It is a vial shield for accommodating a vial in which a disk-shaped radiation shielding upper cover having an opening is detachably fixed. In the vial shield according to the present invention, since the diameter of the first open end side of the main body case is larger than the outer diameter of the vial to be accommodated, the vial can be taken in and out from the first open end by removing the upper lid. Can be easily performed.

本発明のバイアルシールドは、バイアルを内部に挿入した状態で使用する。バイアルシールドを構成する部材の内、本体ケース上部及び第一放射線遮へい部材は透明材料で構成されているため、本体ケース上部及び第一放射線遮へい部材を通してバイアルシールド内に作業環境の明かりが入りバイアルシールドを放射性核種溶出装置に装着した場合にも、バイアルから液を抜き取る場合にも、バイアルシールド内が明るく、内部が良く見え、遮へい効果を損なうことなく操作性が向上する。
また、本体ケース内に第一放射線遮へい部材、第二放射線遮へい部材及び底部放射線遮へい部材を接着剤等を用いることなく、順に収容しているだけなので、万一高価な透明の第一放射線遮へい部材が破損した場合でも、第一放射線遮へい部材のみを交換すれば良い。また、第一放射線遮へい部材は、単純な円筒形をしているので加工が容易であり、従って費用を抑えることができる。第一放射線遮へい部材以外の部材が壊れた場合も、当該部材のみを交換すれば良いので経済的である。 The vial shield of the present invention is used with the vial inserted therein. Among the components that make up the vial shield, the upper part of the main body case and the first radiation shielding member are made of a transparent material, so the light of the working environment enters the vial shield through the upper part of the main body case and the first radiation shielding member. When the is attached to the radionuclide elution apparatus or when the liquid is extracted from the vial, the inside of the vial shield is bright and the inside is visible, and the operability is improved without impairing the shielding effect.
Moreover, since the first radiation shielding member, the second radiation shielding member, and the bottom radiation shielding member are simply accommodated in this order without using an adhesive or the like, the transparent first radiation shielding member is expensive. Even if it is damaged, only the first radiation shielding member needs to be replaced. Moreover, since the first radiation shielding member has a simple cylindrical shape, it can be easily processed, and thus the cost can be reduced. Even when a member other than the first radiation shielding member is broken, it is economical because only the member needs to be replaced.

第二の本発明は、第一の開放端および第二の開放端を有する略円筒状の本体ケースであって、第一の開放端は内側に向かって張り出した縁状の出っ張りにより本体ケースの内径より小さく、収容するバイアルの外径より大きな口径を有する開口部が形成されている、全体が透明材料で構成された略円筒状の本体ケースに、円筒状であって収容するバイアルの外径以上の内径を有し、バイアル内の放射能を遮へいするのに十分な厚みを持ち、本体ケースの第一の開放端の開口部の口径より大きく、本体ケース内径よりも小さい外径を有し、軸方向に一定の高さを有する透明放射線遮へい材料で構成された第一放射線遮へい部材、円筒状であって第一放射線遮へい部材とほぼ等しい外径及び内径を有し、軸方向に一定の高さを有する透明放射線遮へい材料で構成された円筒状の第二放射線遮へい部材、および外径が第二放射線遮へい部材の外径とほぼ同じで、一定の高さを有する略円盤状の放射線遮へい部材により構成された底部放射線遮へい部材が本体ケースの第一の開放端側から順に交換可能に配置され、前記第一放射線遮へい部材の高さと第二放射線遮へい部材の高さの合計が収容されるバイアルの高さとほぼ等しく、本体ケースの第二の開放端に着脱可能に設けられる底蓋を装着することにより前記部材が本体ケース内に固定され、本体ケースの第一の開放端側には、一部または全部が放射線遮へい材料で構成された、中央に開口部を有する円盤状の放射線遮へい性上蓋が着脱可能に固定されている、内部にバイアルを収容するためのバイアルシールドである。
第二の本発明のバイアルシールドは、ケース全体が透明材料で構成され、第一放射性遮へい部材、第二放射性遮へい部材も透明材料で構成されているため、第一の発明のバイアルシールドよりもさらに内部が明るく、操作性が向上している。また、また、第一の発明と同様に、本体ケース内に第一放射線遮へい部材、第二放射線遮へい部材及び底部放射線遮へい部材を接着剤等を用いることなく、順に収容しているだけなので、万一高価な透明の第一放射線遮へい部材または第二放射線遮へい部材が破損した場合でも、当該部材のみを交換すれば良い。また、第一放射線遮へい部材、第二放射線遮へい部材とも、単純な円筒形をしているので加工が容易であり、従って費用を抑えることができる。 The second aspect of the present invention is a substantially cylindrical main body case having a first open end and a second open end, and the first open end is formed by an edge-shaped protrusion protruding inward. An outer diameter of a vial that is cylindrical and accommodated in a substantially cylindrical main body case that is entirely formed of a transparent material and has an opening that is smaller than the inner diameter and larger than the outer diameter of the vial to be accommodated. It has the above inner diameter, is thick enough to block the radioactivity in the vial, has an outer diameter that is larger than the diameter of the opening of the first open end of the main body case and smaller than the inner diameter of the main body case. A first radiation shielding member composed of a transparent radiation shielding material having a constant height in the axial direction, cylindrical and having an outer diameter and an inner diameter substantially equal to the first radiation shielding member, and being constant in the axial direction Transparent radiation shield with height A cylindrical second radiation shielding member made of a material and a bottom made of a substantially disk-shaped radiation shielding member having an outer diameter substantially the same as the outer diameter of the second radiation shielding member and having a certain height A radiation shielding member is disposed so as to be exchangeable in order from the first open end side of the main body case, and the sum of the height of the first radiation shielding member and the height of the second radiation shielding member is approximately equal to the height of the vial to be accommodated. The member is fixed in the main body case by attaching a detachable bottom cover to the second open end of the main body case, and a part or all of the radiation is exposed to the first open end side of the main body case. It is a vial shield for containing a vial in which a disk-shaped radiation shielding upper lid made of a shielding material and having an opening in the center is detachably fixed.
The vial shield according to the second aspect of the present invention is made of a transparent material as a whole, and the first radioactive shielding member and the second radioactive shielding member are also composed of a transparent material. The interior is bright and operability is improved. Also, as in the first invention, the first radiation shielding member, the second radiation shielding member, and the bottom radiation shielding member are simply accommodated in this order without using an adhesive or the like in the main body case. Even when an expensive transparent first radiation shielding member or second radiation shielding member is damaged, only the member needs to be replaced. Moreover, since both the first radiation shielding member and the second radiation shielding member have a simple cylindrical shape, the processing is easy, and thus the cost can be reduced.

本発明は、また、上記バイアルシールドの、第一放射線遮へい部材と第二放射線遮へい部材の間に放射線遮へい性弾性部材をさらに設けたものであっても良い。これによって、両者が直接接触しなくなるため割れを防止できるだけでなく、バイアルシールドを組み立てる際の底蓋をねじ締めする場合の緩衝材にもなり、遮へい能力を損なうことなくより確実に遮へい部材を固定できる。 In the present invention, the vial shield may further include a radiation shielding elastic member between the first radiation shielding member and the second radiation shielding member. As a result, they can be prevented from cracking because they are not in direct contact with each other, and it can also be used as a cushioning material when screwing the bottom lid when assembling a vial shield, so that the shielding member can be fixed more securely without impairing the shielding ability. it can.

以上の通り、本発明のバイアルシールドは透明部材を多く使用しているため内部が明るく、操作性を向上させることができる。また透明放射線遮へい部材自体は壊れやすいが、各部材を独立して交換することができる様になっているので、壊れてもその放射線遮へい部材だけを交換することができ、経済性を向上させることができる。 As described above, the vial shield of the present invention uses many transparent members, so that the inside is bright and the operability can be improved. In addition, the transparent radiation shielding member itself is fragile, but each member can be replaced independently. Therefore, even if it is broken, only the radiation shielding member can be replaced, improving the economy. Can do.

本発明のバイアルシールドの分解斜視図である。It is a disassembled perspective view of the vial shield of this invention. 本発明のバイアルシールドを組み立てた状態における、底蓋付近の断面図である。It is sectional drawing of the bottom cover vicinity in the state which assembled the vial shield of this invention. 本発明のバイアルシールドを組み立てた状態における、上蓋付近の断面図である。It is sectional drawing of the upper cover vicinity in the state which assembled the vial shield of this invention. 本発明のバイアルシールドにオーバーキャップを被せた図である。It is the figure which put the overcap on the vial shield of the present invention. ア、イ、ウは、それぞれバイアルシールドから漏洩する放射能を測定する検出器の位置を示している。A, B, and C respectively indicate the positions of detectors that measure the radioactivity leaking from the vial shield. 放射線核種溶出装置の断面図である。It is sectional drawing of a radionuclide elution apparatus. 従来技術のバイアルシールドである。Figure 2 is a prior art vial shield. 従来技術のバイアルシールドである。Figure 2 is a prior art vial shield. バイアルを表す斜視図である。It is a perspective view showing a vial.

以下、図を参照しながら本発明を詳述するが、好ましい態様の例示であって、本発明の技術的思想の範囲を限定するものではない。
図１は、本発明のバイアルシールドの分解斜視図である。本体ケース１０は、略円筒形で、プラスチック等で形成され、第一の開放端１１側に縁状出っ張り１３を有する。本発明のバイアルシールドは図６で示したような放射性核種溶出装置の無菌バイアル挿入凹部に嵌めるためにも使用されるので、好ましい態様におけるその外形も無菌バイアル挿入部の大きさに合わせた大きさとなる。本体ケースの縁状出っ張り１３の存在により第一の開放端側の開口部１８の口径は内部に収容した第一放射線遮へい部材３０等の外径より小さくなり、これによって第一放射線遮へい部材３０が第一の開放端１１側から抜け落ちるのを防止している。本体ケースの第一の開放端１１および第二の開放端１２の周囲にはそれぞれネジ部１６およびねじ部１７が設けられており、放射線遮へい性上蓋８０および底蓋７０が着脱可能に取り付けられる。本体ケース１０の第二の開放端側に当たる本体ケース胴部１５には、後述する第二放射線遮へい部材４０に設けた透明放射線遮へい部材用枠部４２が重なってはめ込まれるよう、透明放射線遮へい部材用枠部４２の外形に対応した形状の窓枠２１が側面の一部に突き出して設けられ、窓枠の外側の面には覗き窓２３が配置されている。覗き窓２３は図６に示したような放射性核種溶出装置にバイアルシールドを取り付けたとき、溶出液流出ニードル１１８からバイアル内に流入した放射性溶液の状態を視認するため設けられている。窓枠には後述する第二放射線遮へい部材の透明放射線遮へい部材用枠部および透明放射線遮へい部材がはめ込められる。透明放射線遮へい部材は比重が金属鉛の半分以下であるため放射線遮へい部材と同程度に放射線を遮へいするためには鉛の２倍以上の厚みを必要とする。窓枠を突出させて設けるのは厚みのある透明放射線遮へい部材を本体ケースに収容するためである。窓枠の底にあたる部分及び本体ケース下ねじ部１７の内、窓枠の下方に該当する部分は第二放射線遮へい部材をケース内に収容するため開放されている。窓枠は内部の様子を視認するのに必要な大きさがあればよく、図６の放射性核種溶出装置の無菌減圧バイアル挿入凹部１０８に本体ケースを挿入する際に邪魔にならない大きさであることが必要となる。好ましい態様において本体ケースの第一の開放端側は、円筒の軸方向に、第一の開放端から第二の開放端に向かって第一放射線遮へい部材の高さとほぼ等しい長さまで透明材料で形成された本体ケース上部１４が構成されている。その高さは、バイアルシールドを無菌バイアル挿入凹部１１８に装着する際に、バイアルシールド内に収容されているバイアルに溶出液流出ニードルが挿入される様子が視認できる程度あれば良い。流出液溶出ニードルが挿入される様子が視認できる高さがあれば、バイアルシールドに格納された無菌バイアル内に溶出された液の使用時において、注射器を用いてバイアルから放射性液を抜き取る際にも注射針の先端を視認できるので使いやすい。なお、本発明にかかるバイアルシールドの本体ケースにおいて少なくとも一部が透明材料である限りにおいて特に限定する必要はなく、ケース全体を透明材料で構成しても特に問題は無い。要は、第一放射線遮へい部材と第二の放射線遮へい部材をケース内に収容でき、透明材料で形成された第一の放射線遮へい部材を通してバイアル内部が視認できればよい。 Hereinafter, the present invention will be described in detail with reference to the drawings, but it is an example of a preferred embodiment and does not limit the scope of the technical idea of the present invention.
FIG. 1 is an exploded perspective view of the vial shield of the present invention. The main body case 10 has a substantially cylindrical shape and is made of plastic or the like, and has an edge-shaped protrusion 13 on the first open end 11 side. Since the vial shield of the present invention is also used to fit into the sterile vial insertion recess of the radionuclide elution apparatus as shown in FIG. 6, its outer shape in a preferred embodiment has a size that matches the size of the sterile vial insertion part. Become. The diameter of the opening 18 on the first open end side is smaller than the outer diameter of the first radiation shielding member 30 and the like accommodated therein due to the presence of the edge protrusion 13 of the main body case, whereby the first radiation shielding member 30 is formed. It is prevented from falling off from the first open end 11 side. A screw portion 16 and a screw portion 17 are provided around the first open end 11 and the second open end 12 of the main body case, respectively, and the radiation shielding upper cover 80 and the bottom cover 70 are detachably attached. For the transparent radiation shielding member, a transparent radiation shielding member frame portion 42 provided on the second radiation shielding member 40 described later is fitted on the body case body portion 15 corresponding to the second open end side of the body case 10. A window frame 21 having a shape corresponding to the outer shape of the frame portion 42 is provided so as to protrude from a part of the side surface, and a viewing window 23 is disposed on the outer surface of the window frame. The observation window 23 is provided for visually confirming the state of the radioactive solution flowing into the vial from the eluate outflow needle 118 when the vial shield is attached to the radionuclide elution apparatus as shown in FIG. The window frame is fitted with a transparent radiation shielding member frame portion and a transparent radiation shielding member of a second radiation shielding member, which will be described later. Since the transparent radiation shielding member has a specific gravity less than half that of metallic lead, it requires a thickness that is at least twice that of lead in order to shield radiation to the same extent as the radiation shielding member. The window frame is provided so as to protrude so as to accommodate a thick transparent radiation shielding member in the main body case. Of the portion corresponding to the bottom of the window frame and the lower portion 17 of the main body case, the portion corresponding to the lower portion of the window frame is opened to accommodate the second radiation shielding member in the case. The window frame only needs to have a size necessary for visually recognizing the inside of the window frame, and has a size that does not interfere with the insertion of the main body case into the sterile decompression vial insertion recess 108 of the radionuclide elution apparatus of FIG. Is required. In a preferred embodiment, the first open end side of the body case is formed of a transparent material in the axial direction of the cylinder from the first open end to the second open end to a length approximately equal to the height of the first radiation shielding member. The main body case upper part 14 is configured. The height may be such that when the vial shield is attached to the sterile vial insertion recess 118, it can be visually recognized how the eluate outflow needle is inserted into the vial accommodated in the vial shield. As long as the effluent elution needle can be seen to be inserted, when using the liquid eluted in a sterile vial stored in the vial shield, it is necessary to remove radioactive liquid from the vial using a syringe. Easy to use because the tip of the needle can be seen. In addition, as long as at least one part is a transparent material in the main body case of the vial shield concerning this invention, it is not necessary to specifically limit, and even if it comprises the whole case with a transparent material, there will be no problem in particular. In short, it is only necessary that the first radiation shielding member and the second radiation shielding member can be accommodated in the case, and the inside of the vial can be visually recognized through the first radiation shielding member formed of a transparent material.

本体ケース内の第一の開放端１１側に収容する第一放射線遮へい部材３０には鉛ガラスや鉛フリー放射線遮へいガラス等の透明放射線遮へい材料が使用され、内部のバイアルの状態が視認できるように構成される。この部分に透明放射線遮蔽材料を使用することによって、放射線被ばくを防ぎつつ、図６に示したような放射性核種溶出装置１００の溶出液流出ニードルへの取り付け状況やバイアルから液を取り出す際の注射針の穿刺状況を視認することができる。第一放射線遮へい部材３０の形状は、均一な壁厚を有する円筒形であり、円筒の外径は本体ケースに収容可能なように本体ケースの内径より小さく、また本体ケースの第一の開放端側から脱落しないよう本体ケースの縁状出っ張り１３の存在により本体ケースの内径より小さくなった開口部の口径よりも大きい。円筒の厚みはバイアル内の溶出液からの放射線を遮へいすることができる厚みを有することが必要である。また、円筒の内径はバイアルを収容するため、バイアルの外径より大きいことが必要である。これらの条件を満たすため、第一放射線遮へい部材の材料は、バイアルに溶出される放射性溶液の核種や放射能濃度、放射性薬液の量を考慮した適切な材料や厚みが選択される。第一放射線遮へい部材は内部を視認できるよう透明部材を使用しているので、同じく透明材料を使用している本体ケース上部１４と重なるようにすることで透明材料を用いた効果が発揮されることから、好ましくはその高さは本体ケース１０の透明部分の高さとほぼ等しい。第一放射線遮へい部材３０の外側面及び内側面は内部が視認可能なように磨かれ、上下面は加工のしやすさから平行な平面が好適である。第一放射線遮へい部材３０はこのように簡単な形状を有しているので、製造が容易であり、高価な放射線遮へいガラスを材料とした場合であっても、比較的低価格で提供することができる。 Transparent radiation shielding material such as lead glass or lead-free radiation shielding glass is used for the first radiation shielding member 30 accommodated on the first open end 11 side in the main body case so that the state of the internal vial can be visually confirmed. Composed. By using a transparent radiation shielding material for this part, while preventing radiation exposure, the attachment state of the radionuclide elution device 100 as shown in FIG. 6 to the eluate outflow needle and the injection needle when taking out the liquid from the vial The puncture situation of can be visually confirmed. The shape of the first radiation shielding member 30 is a cylindrical shape having a uniform wall thickness, and the outer diameter of the cylinder is smaller than the inner diameter of the main body case so as to be accommodated in the main body case, and the first open end of the main body case. The diameter of the opening is smaller than the inner diameter of the main body case due to the presence of the rim-like protrusion 13 of the main body case so as not to fall off from the side. The thickness of the cylinder needs to have a thickness that can shield radiation from the eluate in the vial. Also, the inner diameter of the cylinder needs to be larger than the outer diameter of the vial in order to accommodate the vial. In order to satisfy these conditions, as the material of the first radiation shielding member, an appropriate material and thickness are selected in consideration of the nuclide of the radioactive solution eluted in the vial, the radioactive concentration, and the amount of the radioactive chemical solution. Since the first radiation shielding member uses a transparent member so that the inside can be visually confirmed, the effect of using the transparent material can be demonstrated by overlapping the upper part 14 of the main body case that also uses the transparent material. Therefore, preferably the height is substantially equal to the height of the transparent portion of the main body case 10. The outer side surface and the inner side surface of the first radiation shielding member 30 are polished so that the inside can be visually recognized, and the upper and lower surfaces are preferably parallel planes for ease of processing. Since the first radiation shielding member 30 has such a simple shape, the first radiation shielding member 30 is easy to manufacture, and even when an expensive radiation shielding glass is used as a material, it can be provided at a relatively low price. it can.

第一放射線遮へい部材３０の次に本体ケース１０の第二の開放端１２側から第一の開放端１１側に収容されるのは、第二放射線遮へい部材４０である。第二放射線遮へい部材４０は略円筒状で一定の高さを有し、内径、外径は第一放射線遮へい部材とほぼ等しい。第一放射線遮へい部材と第二放射性遮へい部材の向き合う面は放射線漏洩が無いよう、隙間のないよう構成される。向き合う面は互いに平行な平面であってもよいが、凹凸部分が噛み合うような構成であってもよい。第二放射線遮へい部材の内径、外径は第一放射線遮へい部材とほぼ同じで、本体ケースに収まり、かつバイアルを収容できる大きさであれば良い。本体ケース胴部１５の内側にある第二放射線遮へい部材４０は必ずしも透明放射線遮へい材料を使用する必要はないため、安価で加工性の良い鉛や必要に応じてタングステン等の放射線遮へい性の金属が使用できる。第二の放射線遮へい性部材４０が金属鉛等の光不透過性材料で構成されている場合、第二放射線遮へい部材４０の側面の一部には開口部が設けられ、該開口部周縁から透明放射線遮へい部材用枠部４２が本体ケースの側面の一部に窓枠部２１及び覗き窓２３と重なるよう突出して設けられる。透明放射線遮へい部材用枠部４２に一定の厚みを有する鉛ガラスや鉛フリー放射線遮へいガラス等の透明放射線遮へい体４４を備えることによって放射線を遮へいしつつ、バイアルシールド内部の明るさを確保し、また前記図６に示したような放射性核種溶出装置１００に取り付けた状態で溶出液の流出状態を確認したり、放射性医薬品の調製を行ったりするのを容易にできる。窓枠部の本体ケースから突出した方向の断面の上下方向は高くするほどバイアルシールド内が明るく見やすくなるが、上限は本体ケース胴部の高さであり、断面横方向は放射線核種溶出装置の無菌バイアル挿入部に差し込むのに支障が無い程度におさめられる。 Next to the first radiation shielding member 30, the second radiation shielding member 40 is accommodated from the second open end 12 side of the main body case 10 to the first open end 11 side. The second radiation shielding member 40 is substantially cylindrical and has a certain height, and the inner diameter and the outer diameter are substantially equal to those of the first radiation shielding member. The facing surfaces of the first radiation shielding member and the second radiation shielding member are configured to have no gap so that there is no radiation leakage. The faces facing each other may be planes parallel to each other, but may be configured such that the concavo-convex portions mesh with each other. The inner diameter and outer diameter of the second radiation shielding member are substantially the same as those of the first radiation shielding member, so long as they can be accommodated in the main body case and accommodate the vial. The second radiation shielding member 40 inside the main body case body 15 does not necessarily need to use a transparent radiation shielding material. Therefore, inexpensive and workable lead or a radiation shielding metal such as tungsten is used if necessary. Can be used. When the second radiation shielding member 40 is made of a light-impermeable material such as metallic lead, an opening is provided in a part of the side surface of the second radiation shielding member 40 and transparent from the periphery of the opening. A radiation shielding member frame portion 42 is provided so as to protrude from a part of the side surface of the main body case so as to overlap the window frame portion 21 and the observation window 23. The transparent radiation shielding member frame portion 42 is provided with a transparent radiation shielding body 44 such as lead glass or lead-free radiation shielding glass having a certain thickness, thereby ensuring the brightness inside the vial shield while shielding radiation. It is possible to easily check the outflow state of the eluate and prepare the radiopharmaceutical while attached to the radionuclide elution apparatus 100 as shown in FIG. The higher the vertical direction of the cross section of the window frame that protrudes from the main body case, the brighter the inside of the vial shield becomes, and the easier it is to see, but the upper limit is the height of the main body case body. It can be stored to such an extent that there is no hindrance to insertion into the vial insertion part.

第二の本発明では、第一の本発明における本体ケース１０の全体が透明材料で形成されており、透明の第一放射線遮へい部材３０及び第二の放射線遮へい部材４０の両方に透明放射線遮へい部材を使用する。この場合、第二放射線遮へい部材４０には鉛ガラスや鉛フリー放射線遮へいガラス等の透明放射線遮へい材料を使用する。これによってバイアルシールドの内部の視認性を一層高め、またバイアル内部の明るさを確保できる。本体ケース１０、第二放射線遮へい部材４０が共に透明であれば、内部が視認できるので第一の本発明において述べた第二放射線遮へい部材の側面に設けた覗き窓は必要なく、したがって第二放射線遮へい部材は第二の開放端側の窓枠部や透明放射線遮へい部材用枠部は必要なく、単純な円筒形であれば良いので、加工が容易である。 In the second aspect of the present invention, the entire main body case 10 in the first aspect of the present invention is formed of a transparent material, and both the transparent first radiation shielding member 30 and the second radiation shielding member 40 are transparent radiation shielding members. Is used. In this case, the second radiation shielding member 40 is made of a transparent radiation shielding material such as lead glass or lead-free radiation shielding glass. Thereby, the visibility inside the vial shield can be further enhanced, and the brightness inside the vial can be secured. If the main body case 10 and the second radiation shielding member 40 are both transparent, the inside can be visually recognized, so that the viewing window provided on the side surface of the second radiation shielding member described in the first aspect of the present invention is not necessary, and therefore the second radiation. The shielding member does not require a window frame portion on the second open end side or a transparent radiation shielding member frame portion, and may be a simple cylindrical shape and can be easily processed.

第一の本発明及び第二の本発明における別の態様においては、上記バイアルシールドの、第一放射線遮へい部材と第二放射線遮へい部材の間に放射線遮へい性弾性部材をさらに設けることができる。これによって、両者が直接接触しなくなるため割れを防止できるだけでなく、バイアルシールドを組み立てる際の底蓋をねじ締めする場合の緩衝材にもなり、遮へい能力を損なうことなくより確実に遮へい部材を固定できる。
放射線遮へい性弾性部材３５は外径、内径ともに第一放射線遮へい部材、第二放射線遮へい部材にほぼ等しい円筒状で、第一放射線遮へい部材３０と第二放射線遮へい部材４０の間に圧接して使用する。放射線遮へい性弾性部材の好ましい態様としては、タングステン、鉛、ビスマス等の重金属粉をゴムに練り込んで製造されたものが使用できる。放射線遮へい性弾性部材は、圧力に応じて変形し、第一放射線遮へい部材と第二放射線遮へい部材の隙間を埋める要求を満たすため第一放射線遮へい部材や第二放射線遮へい部材、底蓋が本体ケースに収まる範囲内で一定以上の厚みを有することが望ましい。たとえば０．２ｍｍから１．０ｍｍ厚みのものが好適に使用される。放射線遮へい性弾性部材は弾性を有するため、圧接することによって、容易に隙間を無くすことができ、放射線漏洩を防止することができる。圧接は、後述する底蓋７０を本体ケースに取りつける際のネジ締めと同時に行われる。 In another aspect of the first invention and the second invention, a radiation shielding elastic member can be further provided between the first radiation shielding member and the second radiation shielding member of the vial shield. As a result, they can be prevented from cracking because they are not in direct contact with each other, and it can also be used as a cushioning material when screwing the bottom lid when assembling a vial shield, so that the shielding member can be fixed more securely without impairing the shielding ability. it can.
The radiation shielding elastic member 35 has a cylindrical shape whose outer diameter and inner diameter are substantially equal to the first radiation shielding member and the second radiation shielding member, and is used by being pressed between the first radiation shielding member 30 and the second radiation shielding member 40. To do. As a preferred embodiment of the radiation shielding elastic member, one produced by kneading heavy metal powder such as tungsten, lead, bismuth or the like into rubber can be used. The radiation shielding elastic member is deformed according to the pressure, and the first radiation shielding member, the second radiation shielding member, and the bottom lid are the main body case to satisfy the requirement to fill the gap between the first radiation shielding member and the second radiation shielding member. It is desirable to have a certain thickness or more within a range that falls within the range. For example, a material having a thickness of 0.2 mm to 1.0 mm is preferably used. Since the radiation shielding elastic member has elasticity, it is possible to easily eliminate the gap and prevent radiation leakage by press-contacting. The pressure contact is performed simultaneously with screw tightening when a bottom lid 70 described later is attached to the main body case.

バイアルシールド内部の視認性を高めたい場合には底部放射線遮へい部材５０及緩衝材７５および底蓋７０に透明材料が用いられる。たとえば底部放射線遮へい部材に鉛ガラス、底蓋７０には透明プラスチック、緩衝材７５に光透過性の高い発泡ポリスチレン材料等を用いることによって、バイアルシールド内部の明るさを確保することができる。 In order to improve the visibility inside the vial shield, a transparent material is used for the bottom radiation shielding member 50, the buffer material 75, and the bottom lid 70. For example, by using lead glass for the bottom radiation shielding member, transparent plastic for the bottom lid 70, and a foamed polystyrene material having a high light transmission property for the buffer material 75, the brightness inside the vial shield can be ensured.

本体ケース１０内に組み入れられた第一放射線遮へい部材３０、放射線遮へい性弾性部材３５、第二放射線遮へい部材４０、底部放射線遮へい部材５０等を固定するため、底蓋７０が使用される。底蓋に設けられたねじ部７２は本体ケースの下ネジ部１７に取り付けられる。第一放射線遮へい部材３０および第二放射線遮へい部材４０の高さの合計は収容するバイアルよりも高くなるよう設計される必要があり、好ましく態様はほぼ同じ高さである。そうすることによってバイアルをバイアルシールド内にしっかり固定できる。放射線遮へい性弾性部材を第一放射線遮へい部材３０と第二放射線遮へい部材４０の間に放射線遮へい性弾性部材を挿入して底蓋を装着すれば、本体ケース内に組み込まれた遮へい部材はしっかりと固定される。放射線遮へい性弾性部材３５を使用した場合も第一放射線遮へい部材３０、第二放射線遮へい部材４０、放射線遮へい性弾性部材３５及び底蓋７０の高さの合計をほぼ本体ケースの高さにすることによって、底蓋を装着することによって本体ケース内に組み込まれた遮へい部材はしっかりと固定される。底蓋７０を本体ケースから外せば、本体ケース内に組み入れた放射線遮へい部材はすべて取り出すことができ、ばらばらになるので、一部の部品が傷つき、または破損等していても当該部品のみを容易に交換することができる。底蓋７０は通常、光不透過性の着色プラスチックが使用されるが、バイアルシールドの内部をより明るくするため底部放射線遮へい部材５０に透明材料が使用されている場合には、底蓋７０にも透明プラスチック材料が使用される。
底蓋７０を取り付けると、本体ケース内部には図９に示したバイアル９０を収容する空間が形成される。 A bottom cover 70 is used to fix the first radiation shielding member 30, the radiation shielding elastic member 35, the second radiation shielding member 40, the bottom radiation shielding member 50 and the like incorporated in the main body case 10. The screw portion 72 provided on the bottom cover is attached to the lower screw portion 17 of the main body case. The sum of the heights of the first radiation shielding member 30 and the second radiation shielding member 40 needs to be designed to be higher than that of the vials to be accommodated, and the preferred embodiment is substantially the same height. By doing so, the vial can be securely fixed in the vial shield. If the radiation shielding elastic member is inserted between the first radiation shielding member 30 and the second radiation shielding member 40 and the bottom cover is attached, the shielding member incorporated in the main body case is firmly attached. Fixed. Even when the radiation shielding elastic member 35 is used, the total height of the first radiation shielding member 30, the second radiation shielding member 40, the radiation shielding elastic member 35, and the bottom cover 70 should be approximately the height of the main body case. By this, the shielding member incorporated in the main body case is firmly fixed by attaching the bottom lid. If the bottom cover 70 is removed from the main body case, all the radiation shielding members incorporated in the main body case can be taken out and separated, so even if some parts are damaged or damaged, only those parts can be easily Can be replaced. The bottom lid 70 is usually made of light-opaque colored plastic, but if a transparent material is used for the bottom radiation shielding member 50 in order to make the inside of the vial shield brighter, the bottom lid 70 is also used. Transparent plastic material is used.
When the bottom lid 70 is attached, a space for accommodating the vial 90 shown in FIG. 9 is formed inside the main body case.

したがって、価格や透明性の有無だけでなく、バイアル中の放射性物質の放射能量やエネルギーに応じて、適切な放射線遮蔽材料が適宜選択される。選択した部材の交換は、底蓋７０を開閉するだけで行うことができる。 Therefore, an appropriate radiation shielding material is appropriately selected according to the amount of radioactivity and energy of the radioactive substance in the vial as well as the price and transparency. The selected member can be replaced simply by opening and closing the bottom lid 70 .

放射線遮へい性上蓋８０は、バイアルシールド内部にバイアルを収容する際に外される。本発明のバイアルシールドに使用されるバイアルは、本体ケースの第一の開放端側の縁状出っ張り１３の口径より小さく、また第一放射線遮へい部材３０の内径よりも小さいので、放射線遮へい性上蓋８０を外せばバイアルをバイアルシールド内に導入することができる。バイアルを導入すると、放射線遮へい性上蓋８０のねじ部８２を本体ケース上部のねじ部１６にねじ込むことによって放射線遮へい性上蓋８０が本体ケースに装着されバイアルはバイアルシールドから抜けなくなる。放射線遮へい性上蓋８０には開口部８５があるが、バイアルよりも小さい径となっており、放射線遮へい性上蓋８０をしていればバイアルがバイアルシールドから抜けることはない。
放射線遮へい性上蓋８０の断面図を図３に示す。好ましい態様において、放射線遮へい性上蓋８０は、ほぼ全体がアンチモンを加えて硬性を高めた鉛合金やタングステン等で構成された上蓋放射線遮へい材部８１で構成されており、上蓋放射線遮へい材部８１の外周はさらにプラスチック部８３で覆われている。放射線遮へい性上蓋８０は、図６に示したような放射性核種溶出装置１００の溶出液流出ニードルや薬液調製の際に注射針がバイアル９０のゴム栓９５を穿刺できるようにするための開口部８５を中央に有している。放射性遮へい性上蓋８０の外周プラスチック部８３には本体ケース１０のねじ部１６と結合するための上部ネジ部８２が設けられている。また好ましい態様において、上蓋放射線遮へい材部８１は、放射線遮へい性上蓋８０を本体ケースに装着した際に、第一放射線遮へい部材の内側に少し入り込む形となるよう突出部８４を有している。突出部８４は上蓋放射線遮へい材部８１と第一放射線遮へい部材３０との間に生じる隙間をふさぎ、放射線が漏洩するのを防止している。 The radiation shielding upper lid 80 is removed when the vial is accommodated inside the vial shield. Since the vial used for the vial shield of the present invention is smaller than the diameter of the rim 13 on the first open end side of the main body case and smaller than the inner diameter of the first radiation shielding member 30, the radiation shielding upper lid 80. By removing the, the vial can be introduced into the vial shield. When the vial is introduced, the screw portion 82 of the radiation shielding upper lid 80 is screwed into the screw portion 16 at the upper portion of the main body case, so that the radiation shielding upper lid 80 is attached to the main body case and the vial cannot be removed from the vial shield. Although the radiation shielding upper lid 80 has an opening 85, the diameter is smaller than that of the vial. If the radiation shielding upper lid 80 is provided, the vial does not come out of the vial shield.
A cross-sectional view of the radiation shielding upper lid 80 is shown in FIG. In a preferred embodiment, the radiation shielding upper lid 80 is constituted by an upper lid radiation shielding material portion 81 made of a lead alloy, tungsten, or the like, which has been hardened substantially by adding antimony. The outer periphery is further covered with a plastic part 83. The radiation shielding upper lid 80 has an opening 85 for allowing the injection needle to puncture the rubber stopper 95 of the vial 90 when the eluate outflow needle of the radionuclide elution apparatus 100 as shown in FIG. In the center. An upper screw portion 82 for coupling to the screw portion 16 of the main body case 10 is provided on the outer peripheral plastic portion 83 of the radioactive shielding upper lid 80. Further, in a preferred embodiment, the upper lid radiation shielding material portion 81 has a protruding portion 84 so as to slightly enter the inside of the first radiation shielding member when the radiation shielding upper lid 80 is attached to the main body case. The projecting portion 84 blocks a gap generated between the upper lid radiation shielding material portion 81 and the first radiation shielding member 30 to prevent radiation from leaking.

本発明のバイアルシールドは図９のバイアル９０を収容することができる。バイアル９０の頂部はゴム栓９５で密封されており、ゴム栓は頂部の中央付近を除いた周囲をアルミシール９７で締め付けられている。バイアルは本体ケース１０の上部開口部１８から本体ケースに挿入され、放射線遮へい性上蓋８０をネジ式で取り付けることによって固定される。上蓋８０の中央部には開口部８５が設けられており、バイアル９０をバイアルシールドに入れたまま図６に示したような放射性核種溶出装置１００の無菌バイアル挿入部に嵌め、バイアルのゴム栓を溶出液流出ニードル１１８に穿刺することができる。また、放射性薬液を調製する場合にもバイアルをバイアルシールドに入れたまま、注射針を穿刺できるので放射線の被ばくを避けることができる。 The vial shield of the present invention can accommodate the vial 90 of FIG. The top of the vial 90 is sealed with a rubber stopper 95, and the periphery of the rubber stopper is tightened with an aluminum seal 97 except for the vicinity of the center of the top. The vial is inserted into the main body case from the upper opening 18 of the main body case 10 and fixed by attaching a radiation shielding upper lid 80 with a screw. An opening 85 is provided in the center of the upper lid 80, and the vial 90 is fitted into a sterile vial insertion portion of the radionuclide elution apparatus 100 as shown in FIG. The eluate outflow needle 118 can be punctured. Also, when preparing a radiopharmaceutical solution, radiation can be avoided because the injection needle can be punctured while the vial is still in the vial shield.

バイアルシールドは放射線遮へい性上蓋８０の中央に開口部８５を有するため、この方向の放射線を遮へいすることができない。このため、バイアルの待機時、保管時等は、図４のように放射線遮へい性のオーバーキャップ９９をバイアルシールドの上にかぶせておく。オーバーキャップ９９は、バイアル瓶中の放射性核種が発する放射線を遮へいできるものであれば材質を問わない。 Since the vial shield has an opening 85 in the center of the radiation shielding upper lid 80, radiation in this direction cannot be shielded. For this reason, when the vial is on standby or stored, a radiation shielding overcap 99 is placed on the vial shield as shown in FIG. The overcap 99 may be made of any material as long as it can shield the radiation emitted by the radionuclide in the vial.

以下、本発明のバイアルシールドにおいて、十分な放射線遮へい効果が得られることについて、実施例を挙げ、説明する。
本体ケースに、第一放射線遮へい部材として鉛ガラス製の放射線遮へい部材（外径３７ｍｍ内径２５ｍｍ高さ１２ｍｍ比重５．２）、第二放射線遮へい部材として金属鉛（外径３７ｍｍ内径２５ｍｍ高さ２０比重１１）製の放射線遮へい部材、および金属鉛製の底部放射線遮へい部材を収容したバイアルシールドと、第一放射線遮へい部材と第二放射線遮へい部材の間にさらに放射線遮へい性弾性部材（宮坂ゴム株式会社製、外径３７ｍｍ内径２５ｍｍ高さ１ｍｍ比重８．０）を収容したバイアルシールドの２種を用意した。第二放射線遮へい部材は透明放射線遮へい部材用枠部を有しているため、漏洩放射線は、透明放射線遮へい部材用枠部が放射線測定器の背後に来るようにして測定した（図５）。
Ｔｃ−９９ｍ溶液５ｍｌをいれたバイアル瓶を２本用意し、上記のバイアルシールドに収容した。Ｔｃ−９９ｍ溶液の液面は第一放射線遮へい部材の中央付近に位置している。
線源の放射能量をキャピンテック社製キュリーメータで測定したところ、１２．０６ＧＢｑであった。
バイアルからの漏洩線量をＮａＩ（よう化ナトリウム）シンチレーションサーベーメータＴＣＳ−１６１（製品名、アロカ社製）を用い、サーベーメーターの測定プローブ先端と本体ケースが３ｃｍ(図５のＡ)離れた位置で横方向から測定したところ以下の結果が得られた。なお、サーベーメーターの測定プローブの上下位置は、上部１が第一放射線遮へい部材の中央付近（図５ア）、上部２は第一放射線遮へい部材と第二放射線遮へい部材の境界線付近（図５イ）、下部は第二の放射線遮へい部材の中央付近（図５ウ）とした。 Hereinafter, an example is given and demonstrated that a sufficient radiation shielding effect is obtained in the vial shield of the present invention.
The main body case has a lead glass radiation shielding member (outer diameter 37 mm, inner diameter 25 mm, height 12 mm, specific gravity 5.2) as the first radiation shielding member, and metal lead (outer diameter 37 mm, inner diameter 25 mm, height 20 specific gravity) as the second radiation shielding member. 11) A radiation shielding member made of metal, a vial shield containing a bottom radiation shielding member made of metal lead, and a radiation shielding elastic member (Miyasaka Rubber Co., Ltd.) between the first radiation shielding member and the second radiation shielding member. Two types of vial shields containing an outer diameter of 37 mm, an inner diameter of 25 mm, a height of 1 mm, and a specific gravity of 8.0) were prepared. Since the second radiation shielding member has a transparent radiation shielding member frame, leakage radiation was measured so that the transparent radiation shielding member frame was behind the radiation measuring instrument (FIG. 5).
Two vials containing 5 ml of the Tc-99m solution were prepared and accommodated in the vial shield. The liquid level of the Tc-99m solution is located near the center of the first radiation shielding member.
It was 12.06 GBq when the amount of radioactivity of the radiation source was measured with a Curiemeter manufactured by Cappintech.
The leakage dose from the vial was measured using a NaI (sodium iodide) scintillation survey meter TCS-161 (product name, manufactured by Aloka) at a position where the measurement probe tip of the survey meter and the main body case were 3 cm apart (A in FIG. 5). When measured from the lateral direction, the following results were obtained. The upper and lower positions of the measurement probe of the survey meter are such that the upper part 1 is near the center of the first radiation shielding member (FIG. 5A), and the upper part 2 is near the boundary between the first radiation shielding member and the second radiation shielding member (FIG. 5). B) The lower part is located near the center of the second radiation shielding member (FIG. 5C).

放射性医薬品基準（平成８年１０月１日）において、放射線遮へい容器には、容器の外装の表面において２ｍＳｖ毎時以下、容器の外装の表面から１ｍ離れた位置において１００μＳｖ以下となる遮へい能力が要求されているが、表１に示したとおり、本発明の２つの態様においていずれもこの要求を十分に満たす遮へい能力を有することが確認された。 Under the Radiopharmaceutical Standard (October 1, 1996), radiation shielding containers are required to have a shielding ability of 2 mSv or less on the outer surface of the container and 100 μSv or less at a position 1 m away from the outer surface of the container. However, as shown in Table 1, it was confirmed that both of the two aspects of the present invention have a shielding ability that sufficiently satisfies this requirement.

１０・・・・本体ケース
１１・・・・第一の開放端
１２・・・・第二の開放端
１３・・・・縁状出っ張り
１４・・・・本体ケース上部
１５・・・・本体ケース胴部
１６・・・・本体ケース上ねじ部
１７・・・・本体ケース下ねじ部
１８・・・・開口部
２１・・・・窓枠部
２３・・・・覗き窓
３０・・・・第一放射線遮へい部材
３５・・・・放射線遮へい性弾性部材
４０・・・・第二放射線遮へい部材
４２・・・・透明放射線遮へい部材用枠部
４４・・・・透明放射線遮へい窓部材
５０・・・・底部放射線遮へい部材
５２・・・・上部外縁
７０・・・・底蓋
７２・・・・底蓋ねじ部
７５・・・・緩衝材
８０・・・・放射線遮へい性上蓋
８１・・・・上蓋放射線遮へい材部
８２・・・・上蓋ねじ部
８３・・・・上蓋プラスチック部
８４・・・・突出部
８５・・・・開口部
９０・・・・バイアル
９５・・・・ゴム栓
９７・・・・アルミシール
９８・・・・サーベーメーター
９９・・・・オーバーキャップ
１００・・・放射線核種溶出装置
１０２・・・本体ケース
１０４・・・蓋体
１０６・・・生理食塩液バイアル挿入凹部
１０８・・・無菌減圧バイアル挿入凹部
１１０・・・放射性核種溶出カラム
１１２・・・生理食塩液流通管
１１４・・・溶出液流通管
１１６・・・生理食塩液流入ヌードル
１１８・・・溶出液流出ニードル
１２０・・・生理食塩液バイアル
１２２・・・無菌減圧バイアル
１２４・・・バイアルシールド
２００・・・バイアルシールド
２０１・・・本体ケース胴部
２０２・・・開口部
２０３・・・上蓋
２０４・・・底蓋
２０５・・・鉛ガラス製窓部
３００・・・バイアルシールド
３０１・・・本体ケース
３０２・・・透明遮へい部材
３０３・・・上蓋
３０４・・・底蓋
３０５・・・開口部
10 .... main body case 11 .... first open end 12 .... second open end 13 .... edge-like ridge 14 ...... main body case upper part 15 .... main body case Body 16 ··· Upper screw portion of main body case 17 ··· Lower screw portion of main body case 18 ··· Opening portion 21 ··· Window frame portion 23 ··· Viewing window 30 ··· Radiation shielding member 35 ... Radiation shielding elastic member 40 ... Second radiation shielding member 42 ... Transparent radiation shielding member frame 44 ... Transparent radiation shielding window member 50 ... · Bottom radiation shielding member 52 ··· Upper outer edge 70 · · · Bottom lid 72 · · · Bottom lid screw portion 75 · · · Buffer 80 · · · Radiation shielding upper lid 81 · · · Top lid Radiation shielding material part 82 ... Upper cover screw part 83 ... Upper cover plastic 84 ··· Projection 85 ··· Opening 90 ··· Vial 95 · · · Rubber stopper 97 · · · Aluminum seal 98 · · · Serve meter 99 · · · Overcap 100 · · · ··· Radionuclide elution device 102 ··· Body case 104 ··· Lid 106 ··· Saline vial insertion recess 108 ··· Aseptic vacuum vial insertion recess 110 · · · Radionuclide elution column 112 · · · Physiology Saline solution pipe 114 ... Eluate flow pipe 116 ... Saline solution inflow noodle 118 ... Eluate outflow needle 120 ... Saline solution vial 122 ... Aseptic decompression vial 124 ... Vial shield 200 ... vial shield 201 ... body case trunk 202 ... opening 203 ... top lid 204 ... bottom lid 205 ... lead Glass window part 300 ... Vial shield 301 ... Main body case 302 ... Transparent shielding member 303 ... Top cover 304 ... Bottom cover 305 ... Opening part

Claims

A substantially cylindrical main body case having a first open end and a second open end, wherein the first open end is accommodated smaller than the inner diameter of the main body case by an edge-shaped protrusion projecting inward. An opening having a larger diameter than the outer diameter of the vial is formed, and an upper part of the main body case made of a transparent material is formed at a constant height from the first open end to the second open end in the axial direction. A part of the side surface on the second open end side is formed with a window frame portion protruding from the main body case, and at least the outer surface of the window frame portion is formed of a transparent material,
It is cylindrical, has a height approximately equal to the height of the upper part of the main body case, has an inner diameter that is equal to or greater than the outer diameter of the vial to be accommodated, and has a thickness sufficient to shield the radioactivity in the vial. A first radiation shielding member made of a transparent radiation shielding material having an outer diameter larger than the diameter of the opening of the first open end of the case and smaller than the inner diameter of the main body case;
A second radiation shielding member having a substantially cylindrical shape and having an outer diameter and an inner diameter substantially equal to those of the first radiation shielding member, and comprising a radiation shielding material having a constant height in the axial direction; A part of the side surface of the two radiation shielding member has an opening, and is a frame projecting from the periphery of the opening, and has a shape corresponding to the window frame of the main body case, and overlaps the window frame. A transparent radiation shielding member frame portion formed so as to be fitted is provided, and the transparent radiation shielding member frame portion has a cross section covering at least all of the opening and having a thickness substantially equal to the depth of the transparent radiation shielding frame portion. A second radiation shielding member having a radiation shielding window member made of a simple radiation shielding material, and a substantially disk shape having an outer diameter substantially the same as the outer diameter of the second radiation shielding member and having a constant height in the axial direction. Radiation shielding material Configured bottom radiation shielding member is replaceably arranged in this order from the first open end of the body case by,
A total of the height of the first radiation shielding member and the height of the second radiation shielding member is substantially equal to the height of the vial to be accommodated, and a bottom cover that is detachably attached to the second open end of the main body case is attached. Each member is fixed in the body case by
On the first open end side of the main body case, a disk-shaped radiation shielding upper cover having an opening in the center, which is partially or entirely made of a radiation shielding material, is detachably fixed. Vial shield for containing.

A substantially cylindrical main body case having a first open end and a second open end, wherein the first open end is accommodated smaller than the inner diameter of the main body case by an edge-shaped protrusion projecting inward. In the main body case formed of a transparent material as a whole, an opening having a larger diameter than the outer diameter of the vial is formed.
It is cylindrical and has an inner diameter that is greater than or equal to the outer diameter of the vial to be stored, has a sufficient thickness to shield the radioactivity in the vial, and is larger than the diameter of the opening at the first open end of the main body case, A first radiation shielding member made of a transparent radiation shielding material having an outer diameter smaller than the inner diameter of the main body case and having a certain height in the axial direction;
A second radiation shielding member made of a transparent radiation shielding material which is cylindrical and has an outer diameter and an inner diameter substantially equal to the first radiation shielding member and has a constant height in the axial direction; The bottom radiation shielding member, which is substantially the same as the outer diameter of the radiation shielding member and is constituted by a substantially disk-shaped radiation shielding member having a certain height, is disposed so as to be exchangeable in order from the first open end side of the main body case, A total of the height of the first radiation shielding member and the height of the second radiation shielding member is substantially equal to the height of the vial accommodated, and by attaching a bottom lid detachably provided at the second open end of the main body case. The member is fixed in the body case;
On the first open end side of the main body case, a disk-shaped radiation shielding upper cover having an opening in the center, which is partially or entirely made of a radiation shielding material, is detachably fixed. Vial shield for containing.

Radiation shielding elasticity composed of a cylindrical radiation shielding material that has elasticity between the first radiation shielding member and the second radiation shielding member, and is thin and has approximately the same outer diameter and inner diameter as the first radiation shielding member. 3. The vial shield according to claim 1 or 2, wherein the member is replaceable.