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JP3205560U - 点滴液容器とともに使用するための液体移送デバイス - Google Patents

点滴液容器とともに使用するための液体移送デバイス Download PDF

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JP3205560U
JP3205560U JP2016600070U JP2016600070U JP3205560U JP 3205560 U JP3205560 U JP 3205560U JP 2016600070 U JP2016600070 U JP 2016600070U JP 2016600070 U JP2016600070 U JP 2016600070U JP 3205560 U JP3205560 U JP 3205560U
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レヴ，ニムロッド
シャロム，ニヴ ベン
シャロム，ニヴ ベン
マークス，ヒュー・ザカリー
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メディモップ・メディカル・プロジェクツ・リミテッド
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Abstract

【課題】ニードルレス添加剤制御バルブに基づき、点滴液容器とともに使用するための液体移送デバイスを提供する。【解決手段】液体移送デバイス１０１は、コストを低減するとともに、ユーザの手順を低減することによって使用を容易にするための一体型バイアルアダプタ１０２および／または一体型点滴セット５０を備える。【選択図】図４

Description

本考案は、点滴液容器とともに使用するための液体移送デバイスに関する。
ＷＯ２００７／０５２２５２として公開されたニードルレス添加剤制御バルブという標題の本願出願人の国際出願ＰＣＴ／ＩＬ２００６／００１２２８は、点滴液容器とともに使用することが意図されている。この点滴液容器は、点滴液を収容するとともに、点滴（ＩＶ）ポートすなわち投与ポートを有している。点滴液容器は、点滴液バッグ、点滴液ボトルなどの形態であってもよい。また、ニードルレス添加剤制御バルブは、添加剤移送デバイスとともに使用することが意図されている。この添加剤移送デバイスは、雄コネクタを備えており、薬剤添加物を収容する。適切な添加剤移送デバイスは、とりわけ、ニードルレス注射器、雄バイアルアダプタなどを備えている。また、ニードルレス添加剤制御バルブは、点滴セットとともに使用することが意図されている。点滴セットは、ＩＶスパイクと、患者に投与するためのコネクタと、を有している。
ニードルレス添加剤制御バルブは、三叉コネクタ本体を備えている。この三叉コネクタ本体は、点滴液容器のＩＶポート内にシール挿入するためのＩＶスパイクと、雌コネクタを有するとともに通常は閉じられる（ＮＣ）ニードルレス添加剤ポートと、代替ＩＶポートと、を備えている。ＩＶスパイクは、単一の内腔を有しており、ＮＣニードルレス添加剤ポートは、単一の内腔を有しており、代替ＩＶポートは、単一の内腔を有している。この３つの内腔は、３段階で直接的かつ連続的に流体接続される。代替ＩＶポートは、点滴セットのＩＶスパイクをシール受け入れするために、適切な軟質プラスチック材料（例えば、ＰＶＣなど）から形成される。代替ＩＶスパイクは、点滴セットのＩＶスパイクの挿入時に穿刺されることが意図された膜を備えている。
ニードルレス添加剤制御バルブの一実施形態では、ＮＣニードルレス添加剤ポートは、薬剤添加物を複数添加できるようにするために拭き取ることができる露出面を有する自己シール式アクセスバルブによって構成される。適切な自己シール式アクセスバルブは、とりわけ、Leinsingに付与された米国特許第５，６７６，３４６号に開示されている。複数の添加は、単一の添加で利用可能な場合よりも大量の添加物を導入するために、比較的迅速に連続され得る。あるいは、複数の添加は、患者の病状に応じて、何時間にわたることもある。ニードルレス添加剤制御バルブの他の実施形態では、ＮＣニードルレス添加剤ポートは、手動操作される停止コックなどによって構成され得る。
ＷＯ２００７／０５２２５２の図４Ａおよび図４Ｂには、注射器の内容物を点滴液容器に注入して薬用点滴液を形成することを可能にするため、または、患者に直接投与することを可能にするためのニードルレス注射器を有するニードルレス添加剤制御バルブの使用方法が示されている。
ＷＯ２００７／０５２２５２の図５Ａおよび図５Ｂには、点滴液を点滴液容器からバイアルに１回以上通すか、逆に、バイアルから点滴液容器に１回以上通すことによって、バイアル内容物を点滴液内容物と混合して薬用点滴液を形成できるようにするために、バイアルアダプタとバイアルとともにニードルレス添加剤制御バルブを使用する方法が示されている。
自己シール式アクセスバルブを有するニードルレス添加剤制御バルブは、現在、ペンシルベニア州530 Herman O. West Drive, Exton, 19341のWest Pharmaceutical Services, Inc.,（www.westpharma.com）からVIAL2BAGとの登録商標のもと市販されている。ニードルレス添加剤制御バルブは、複合調剤においてそのような点滴液容器を用意する従前の普及した行為とは対照的に、点滴液容器のベッド側で用意するための普及した使用方法を見出してきた。さらに、ニードルレス添加剤制御バルブは、注射器とは対照的に、より普及した、バイアルとともに使用する方法を見出してきた。
本考案は、上述したＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブに基づいた液体移送デバイスを対象としている。
本考案の第１実施形態によれば、液体移送デバイスは、上述のＮＣニードルレス添加剤ポートに代えて一体型バイアルアダプタを有する三叉コネクタ本体を備えている。この液体移送デバイスは、ＮＣニードルレス添加剤ポートを用いないことによって相対的にコストを著しく節約できるが、以前に可能であった複数の添加とは対照的に、薬剤添加物の点滴液容器への１回の添加に対するその使用を効果的に制限する。したがって、一体型バイアルアダプタを有する液体移送デバイスの使用は、上述のＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブに対して簡素化される。
一体型バイアルアダプタは、好ましくは、その後続の取り外しをなくすために、バイアルにスナップ嵌め取り付けすることが意図されており、それによって、その薬剤添加物が点滴液容器に添加されたことの視覚的表示が提供される。バイアルは、患者への投与中において、少なくとも部分的に、典型的には全体的に、点滴液容器からの薬用点滴液で満たされ、不注意による漏洩をなくす。
本考案の第２実施形態によれば、液体移送デバイスは、一体型バイアルアダプタと一体型点滴セットとを備えている。一体型バイアルアダプタは、上述の利点を提供することができ、一体型点滴セットは、代替ＩＶポートのコストと、点滴セットを穿刺するために点滴セットのＩＶスパイクを挿入する工程と、をなくし、それによって、その使用方法が簡素化される。この使用方法は、薬用点滴液のベッド側での投与に関して特に有利である。
本考案の第３実施形態によれば、液体移送デバイスは、上述のＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブに類似しているが、代替ＩＶスパイクに代えて、本考案の第２実施形態に類似する一体型点滴セットを備えている。
本考案を理解し、それをどのように実施できるのかを理解するために、次に、好ましい実施形態について、同様の部分に同様の番号を付した添付図面を参照して、単なる非限定的な例として説明する。
点滴液バッグと、上述のＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブと、予備充填された注射器と、雄バイアルアダプタと、バイアルと、点滴セットと、を備える従来の投与セットの絵図である。 自己シール式アクセスバルブを有する図１のニードルレス添加剤制御バルブの正面図である。 自己シール式アクセスバルブの正面図である。 その閉状態にある自己シール式アクセスバルブの、図２ＡのＡ−Ａ線に沿った断面図である。 その閉状態にある自己シール式アクセスバルブの、図２ＡのＡ−Ａ線に沿った断面図である。 点滴液バッグと、本考案の第１の好ましい実施形態による液体移送デバイスと、バイアルと、点滴セットと、を備える投与セットの絵図である。 図４の液体移送デバイスの上面図である。 図４の液体移送デバイスの、図５ＡのＡ−Ａ線に沿った縦断面図である。 点滴液バッグと、本考案の第２の好ましい実施形態による液体移送デバイスと、バイアルと、を備える投与セットの絵図である。 点滴液バッグと、本考案の第３の好ましい実施形態による液体移送デバイスと、予備充填された注射器と、バイアルアダプタと、バイアルと、を備える投与セットの絵図である。
図１，２Ａ，２Ｂ，３Ａ，３Ｂは、上述のＷＯ２００７／０５２２５２の図１，２Ａ，２Ｂ，３Ａ，３Ｂにそれぞれ対応している。
図１は、点滴液バッグ１０を示している。この点滴液バッグ１０は、点滴液を収容し、また、点滴（ＩＶ）または投与ポート１１と、添加剤ポート１２と、を有している。また、図１は、上述のＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブ１３と、添加剤移送デバイス１４と、を示している。添加剤移送デバイス１４は、雄ルアーロックコネクタ１６を有している。添加剤移送デバイス１４は、注射器１７や、バイアル１９に入れ子式にスナップ嵌め取り付けするためのバイアルアダプタ１８などによって構成され得る。注射器１７は、点滴液と混合して、患者に投与するための薬用点滴液を形成するために、点滴液バッグ１０に注入するため、または、患者に直接投与するために、薬液で予備充填される。バイアル１９は、バイアルストッパ２０Ｂによってシールされるバイアルボトル２０Ａを備えている。バイアル１９は、投与前に復元が必要となる凍結乾燥粉末薬剤、または、薬液添加物の形態のバイアル内容物を収容する。バイアル内容物は、点滴液と混合して、患者に投与するための薬用点滴液を形成するために、点滴液バッグ１０に導入されることが意図されている。
図１は、さらに、ＩＶポート１１内にシール挿入するためのＩＶスパイク５１を有する従来の点滴セット５０を示している。点滴セット５０は、さらに、第１の管５２と、クランプ５３と、点滴室５４と、第２の管５６と、ローラクランプ５７と、雄ルアーコネクタ５８と、ルアーシールド５９と、を備えている。第１の管５２は、典型的には、４．１ｍｍ×２００ｍｍの寸法を有しており、第２の管５６は、典型的には、４．１ｍｍ×５００ｍｍの寸法を有している。
図２Ａは、上述のＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブ１３が、三叉コネクタ本体２１を有していることを示している。三叉コネクタ本体２１は、ＩＶポート１１内にシール挿入するためのＩＶスパイク２２を備えている。ＩＶスパイク２２は、適切な、剛性を有するプラスチック材料（例えば、ポリカーボネートなど）から形成される。ＩＶスパイク２２は、周囲に配置された孔２４を有する尖った端部２３と、内腔２６と、出口開口２７と、を備えている。ＩＶスパイク２２は、ＩＶポート１１内への挿入を制限するための円形フランジ２８と、出口開口２７に向けて配置される通常は閉じられる（ＮＣ）ニードルレス添加剤ポート２９と、を有する注入モールド一体構造として一体的に形成されている。
ニードルレス添加剤ポート２９は、内腔３１を有しており、雄ルアーロックコネクタ１６をねじ受け入れするための自己シール式アクセスバルブ３２が取り付けられている。アクセスバルブ３２は、段付き外面３３を有している。段付き外面３３は、当接面３４と、リム３６と、を有している。アクセスバルブ３２は、シリコーン製の自己シール式バルブ部材３７を収容する。自己シール式バルブ部材３７は、管状主要部３８と、円筒状ニードルレス入口部３９と、を有している。ニードルレス入口部３９は、露出した入口面４１と、それに沿って延在する予備形成されたスリット４２と、を有している（図２Ｂ参照）。
バルブ部材３７は、自然長Ｌ１を有しており、入口面４１がリム３６と同一面となり、それによって、衛生化のために入口面４１が容易に拭き取られ得るように、寸法が設定されている（図３Ａ参照）。アクセスバルブ３２にねじ取り付けされた雄ルアーコネクタ１６が、当接面３４に当接するまで前進する。その前進中において、雄ルアーコネクタ１６は、圧縮長Ｌ２がＬ２＜Ｌ１となるようにバルブ部材３７を圧縮する。これにより、添加剤移送デバイスと内腔３１との間での流体連通を可能にするために、その予備形成されたスリット４２に沿って入口部３９が分割される（図３Ｂ参照）。
三叉コネクタ本体２１は、代替ＩＶポートによって構成される投与ポート４３を備えている。代替ＩＶポートは、内腔４４とシール膜４６とを有している。内腔４４は、出口開口２７と連続的に流れ連通している。代替ＩＶポート４３は、約５ｍｍから６ｍｍの直径を有するＩＶスパイクをシール受け入れするために適切な軟質プラスチック材料（例えばあ、ＰＶＣなど）から形成されるＩＶポート１１に類似した従来のＩＶポートである。代替ＩＶポート４３は、ＩＶスパイク５１をシール受け入れすることが意図されている。
図４は、投与セット１００を示している。この投与セット１００は、点滴液バッグ１０と、液体移送デバイス１０１と、バイアル１９と、点滴セット５０と、を備えている。液体移送デバイス１０１は、ニードルレス添加剤制御バルブ１３と構造が類似しており、したがって、ＩＶスパイク２２と、ニードルレス添加剤ポート２９と、投与ポート４３と、を備えている。液体移送デバイス１０１は、ニードルレス添加剤ポート２９が一体型バイアルアダプタ１０２によって構成されている点において、ニードルレス添加剤制御バルブ１３と異なっている。また、液体移送デバイス１０１は、ＩＶスパイク２２を保護するシールド１０３を備えている。
図５Ａおよび図５Ｂは、一体型バイアルアダプタ１０２が従来の構成を有していることを示している。この従来の構成は、バイアル１９にスナップ嵌め取り付けするためのスカート１０４と、一体型バイアルアダプタ１０２をバイアル１９にスナップ嵌めする際にバイアル内部と流体連通させるためにそのバイアルストッパ２０Ｂを穿刺するための穿刺部材１０６と、を備えている。穿刺部材１０６は、ＩＶスパイク２２および代替ＩＶポート４３と直接的かつ連続的に流体連通する。
投与キット１００の使用方法は、次の通りである。ＩＶスパイク２２は、ＩＶポート１１内にシール挿入され、バイアルアダプタ１０２は、その薬剤添加物を点滴液バッグ１０に添加するために、バイアル１９にスナップ嵌めされる。そのような添加は、典型的には、点滴液バッグ１０をつぶして、点滴液をバイアル１９内に追い込み、次いで、バイアル内容物がその中に流入するように点滴液バッグ１０を逆さまにすることによって、達成される。バイアル１９が凍結乾燥薬剤添加物を収容する場合には、点滴液は、凍結乾燥薬剤添加物を溶解させる。そのような溶解は、点滴液をバイアル１９内に追いやるとともにバイアル内容物を点滴バッグ１０に流入させるいくつかのサイクルを必要とすることがある。その後、ＩＶスパイク５１は、患者に投与するために、液体移送デバイスの代替ＩＶポート４３内にシール挿入される。
図６は、投与セット１１０を示している。この投与セット１１０は、点滴液バッグ１０と、液体移送デバイス１１１と、バイアル１９と、を備えている。液体移送デバイス１１１は、液体移送デバイス１０１と構造が類似しており、したがって、ＩＶスパイク２２と、ニードルレス添加剤ポート２９と、投与ポート４３と、を備えている。液体移送デバイス１１１は、液体移送デバイス１１１が、代替ＩＶポートに代えて、一体型点滴セット１２２によって構成される投与ポート４３を備えている点において、液体移送デバイス１０１と異なっている。一体型点滴セット１１２は、第１の管５２がコネクタ本体２１に直接的に接続されている点を除いて、点滴セット５０と同様である。
液体移送デバイス１１１の使用方法は、点滴液バッグ１０に薬剤添加物を添加することに関して、液体移送デバイス１０１の使用方法と同様である。
図７は、投与セット１２０を示している。この投与セット１２０は、点滴液バッグ１０と、添加剤移送デバイス１４と、液体移送デバイス１２１と、を備えている。液体移送デバイス１２１は、ニードルレス添加剤制御バルブ１３と構造が類似しており、したがって、ＩＶスパイク２２と、ニードルレス添加剤ポート２９と、投与ポート４３と、を備えている。液体移送デバイス１２１は、液体移送デバイス１２１が、代替ＩＶポートに代えて、一体型点滴セット１２２によって構成される投与ポート４３を備えている点において、ニードルレス添加剤制御バルブ１３と異なっている。液体移送デバイス１２１の使用方法は、その点滴セット１２２が患者に直接的に接続され得る点を除いて、上述のＷＯ２００７／０５２２５２のニードルレス添加剤制御バルブ１３と同様である。
本考案が限られた数の実施形態に関して説明されたが、本考案の多くの変形形態、修正形態および他の用途が添付の実用新案登録請求の範囲内においてなされ得ることが理解されよう。
１０…点滴液バッグ
１１…投与ポート
１２…添加剤ポート
１３…ニードルレス添加剤制御バルブ
１４…添加剤移送デバイス
１６…雄ルアーロックコネクタ
１７…注射器
１８…バイアルアダプタ
１９…バイアル
２１…三叉コネクタ本体
２９…添加剤ポート
３２…自己シール式アクセスバルブ
３７…バルブ部材
３８…管状主要部
４２…スリット
４３…投与ポート
４４…内腔
４６…シール膜
５０…点滴セット
５８…雄ルアーコネクタ
５９…ルアーシールド
１００…投与セット
１０１…液体移送デバイス
１０２…バイアルアダプタ
１０６…穿刺部材
１１０，１２０…投与セット
１１１，１２１…液体移送デバイス
１１２，１２２…一体型点滴セット

Claims (3)

  1. 点滴液を収容するとともに、前記点滴液を投与するための点滴（ＩＶ）ポートを有する点滴液容器と、バイアルストッパによってシールされるとともに薬剤添加物を収容するバイアルボトルを備えるバイアルと、ＩＶポート内にシール挿入するためのＩＶスパイクと患者に投与するためのコネクタとを有する点滴セットと、ともに使用するための液体移送デバイスであって、
    三叉コネクタ本体を備え、
    前記三叉コネクタ本体は、
    ｉ）前記点滴液容器の前記ＩＶポート内にシール挿入するためのＩＶスパイクと、
    ｉｉ）前記バイアルに入れ子式に取り付けるための一体型バイアルアダプタによって構成されるニードルレス添加剤ポートと
    を備え、
    前記一体型バイアルアダプタは、流れ連通させるために前記バイアルアダプタを前記バイアルに前記取り付けする際に前記バイアルストッパを穿刺するための穿刺カニューレを備え、
    前記三叉コネクタ本体は、さらに、
    ｉｉｉ）前記点滴セットの前記ＩＶスパイクをシール受け入れするための代替ＩＶポートによって構成される投与ポートを備え、
    前記ＩＶスパイク、前記一体型バイアルアダプタおよび前記投与ポートは、３段階で直接的かつ連続的に流体連通し、それによって、前記点滴液と混合して薬用点滴液を形成し、それに続いて、前記薬用点滴液を患者に投与するために、前記バイアルから前記点滴液容器への前記薬剤添加物の初期の導入を可能にする
    液体移送デバイス。
  2. 点滴液を収容するとともに、前記点滴液を投与するための点滴（ＩＶ）ポートを有する点滴液容器と、バイアルストッパによってシールされるとともに薬剤添加物を収容するバイアルボトルを備えるバイアルと、ともに使用するための液体移送デバイスであって、
    三叉コネクタ本体を備え、
    前記三叉コネクタ本体は、
    ｉ）前記点滴液容器の前記ＩＶポート内にシール挿入するためのＩＶスパイクと、
    ｉｉ）前記バイアルに入れ子式に取り付けるための一体型バイアルアダプタによって構成されるニードルレス添加剤ポートと
    を備え、
    前記一体型バイアルアダプタは、流れ連通させるために前記バイアルアダプタを前記バイアルに前記取り付けする際に前記バイアルストッパを穿刺するための穿刺カニューレを備え、
    前記三叉コネクタ本体は、さらに、
    ｉｉｉ）患者に投与するためのコネクタを有する一体型点滴セットによって構成される投与ポートを備え、
    前記ＩＶスパイク、前記一体型バイアルアダプタおよび前記一体型点滴セットは、３段階で直接的かつ連続的に流体連通し、それによって、前記点滴液と混合して薬用点滴液を形成し、それに続いて、前記薬用点滴液を患者に投与するために、前記バイアルから前記点滴液容器への薬剤添加物の初期の導入を可能にする
    液体移送デバイス。
  3. 点滴液を収容するとともに、前記点滴液を投与するための点滴（ＩＶ）ポートを有する点滴液容器と、薬剤添加物を収容するとともに雄コネクタを有する添加剤移送デバイスと、ともに使用するための液体移送デバイスであって、
    三叉コネクタ本体を備え、
    前記三叉コネクタ本体は、
    ｉ）前記点滴液容器の前記ＩＶポート内にシール挿入するためのＩＶスパイクと、
    ｉｉ）前記添加剤移送デバイスの前記雄コネクタをシール受け入れするための雌コネクタを有し、通常は閉じられるニードルレス添加剤ポートと
    を備え、
    前記通常は閉じられるニードルレス添加剤ポートは、前記ニードルレス添加剤ポートを通る、雄コネクタの複数回の衛生挿入のための衛生化を可能にするとともに、雄コネクタのシール挿入時に通常の閉状態から開状態に押圧される自己シール式アクセスバルブを有する、露出したニードルレスアクセス面を備え、
    前記三叉コネクタ本体は、さらに、
    ｉｉｉ）投与のためのコネクタを有する一体型点滴セットによって構成される投与ポートを備え、
    前記ＩＶスパイク、前記通常は閉じられるニードルレス添加剤ポート、および、前記一体型点滴セットは、３段階で直接的かつ連続的に流体連通し、それによって、前記添加剤移送デバイスの前記添加物は、前記点滴液と混合され得るか、あるいは、患者に直接的に投与され得る
    液体移送デバイス。
JP2016600070U 2013-08-07 2014-07-25 点滴液容器とともに使用するための液体移送デバイス Expired - Lifetime JP3205560U (ja)

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JP7101900B2 (ja) 2019-01-31 2022-07-15 ウェスト・ファーマ・サービシーズ・アイエル・リミテッド 液体移送装置
CN113490477A (zh) * 2019-01-31 2021-10-08 西医药服务以色列有限公司 移液装置
JP2022508665A (ja) * 2019-01-31 2022-01-19 ウェスト・ファーマ・サービシーズ・アイエル・リミテッド 液体移送装置
JP7001838B2 (ja) 2019-04-30 2022-01-20 ウェスト ファーマ サービシーズ イスラエル リミテッド デュアルルーメンｉｖスパイク付き液体移送装置
KR20220002472A (ko) * 2019-04-30 2022-01-06 웨스트 파마. 서비시즈 일, 리미티드 이중 루멘 iv 스파이크를 갖는 액체 전달 디바이스
JP2021517055A (ja) * 2019-04-30 2021-07-15 ウェスト ファーマ サービシーズ イスラエル リミテッド デュアルルーメンｉｖスパイク付き液体移送装置
US11786442B2 (en) 2019-04-30 2023-10-17 West Pharma. Services IL, Ltd. Liquid transfer device with dual lumen IV spike
JP2022031443A (ja) * 2019-04-30 2022-02-18 ウェスト ファーマ サービシーズ イスラエル リミテッド デュアルルーメンｉｖスパイク付き液体移送装置

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DK201600035Y3 (da) 2016-04-08
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WO2015019343A1 (en) 2015-02-12
GB2533714A (en) 2016-06-29
BR112016001905A2 (pt) 2017-08-01
GB2578705B (en) 2020-11-11
GB201602766D0 (en) 2016-03-30
GB2533714B (en) 2020-04-08
IL243896A0 (en) 2016-04-21
US20160166824A1 (en) 2016-06-16
GB2578705A (en) 2020-05-20
IL243896B (en) 2020-07-30
KR20160001372U (ko) 2016-04-27
DE212014000169U1 (de) 2016-03-14
KR200486088Y1 (ko) 2018-04-02
US10688295B2 (en) 2020-06-23
DK201600035U1 (da) 2016-03-11
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BR112016001905B1 (pt) 2021-12-28
CN205626622U (zh) 2016-10-12

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