JP5993533B2 - 頂部が開口した薬剤容器に取り付けて、ニードルレス注射器とともに使用するための薬剤復元組立体を形成するための薬剤容器閉鎖体 - Google Patents

頂部が開口した薬剤容器に取り付けて、ニードルレス注射器とともに使用するための薬剤復元組立体を形成するための薬剤容器閉鎖体 Download PDF

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JP5993533B2
JP5993533B2 JP2016507113A JP2016507113A JP5993533B2 JP 5993533 B2 JP5993533 B2 JP 5993533B2 JP 2016507113 A JP2016507113 A JP 2016507113A JP 2016507113 A JP2016507113 A JP 2016507113A JP 5993533 B2 JP5993533 B2 JP 5993533B2
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レヴ，ニムロッド
ブクマン，モルデカイ
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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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Description

本発明は、頂部が開口した薬剤容器に取り付けて、ニードルレス注射器とともに使用するためのいわゆる使用準備ができた薬剤復元組立体を形成するための薬剤容器閉鎖体に関する。薬剤容器閉鎖体は、頂部が開口した薬剤容器をシールするための薬剤容器ストッパと、一体型のニードルレス注射器コネクタおよび穿刺カニューレを有する流体移送部材と、を備えている。
頂部が開口した薬剤容器と、一体型のニードルレス注射器コネクタおよび穿刺カニューレを有する流体移送部材を有する薬剤容器閉鎖体と、を備える使用準備ができた復元組立体は、従来技術において公知である。例示的な先行技術には、とりわけ、以下が含まれる。
薬剤を収容するボトル、または、注射器から薬剤を移送するための小型チューブの口すなわち開口を注射器に接続するための安全デバイスという標題のValentiniらに付与された米国特許第４，５７６，２１１号
薬剤移送システムという標題のFowlesらに付与された米国特許第５，４２９，６１４号
医療用コネクタという標題のLopezらに付与された米国特許第５，７７６，１１６号
自身の真空を組み入れた吸引ニードル装置、および、方法、ならびに、それとともに使用するためのアダプタという標題のPowlesらに付与された米国特許第５，９０２，２８０号
特に穿刺されることができるストッパを有する容器と注射器との間での接続デバイスという標題のAneasに付与された米国特許第６，０７０，６２３号
バイアルおよび他の医療用容器のためのプラスチック閉鎖体という標題のThibaultらに付与された米国特許第６，３８２，４４２号
受容器と容器との間の接続のためのデバイス、および、そのようなデバイスを備える使用準備ができた組立体という標題のAneasに付与された米国特許第６，４７８，７８８号
ニードルレスアクセス装置およびシステムという標題のManeraに付与された米国特許第６，７０６，０３１号
希釈剤容器のための摺動式復元デバイスという標題のFowlesらに付与された米国特許第７，０７４，２１６号
注入ペンカートリッジに薬剤を用意するための側部焼成注射器を備えるキットという標題のBurroughsらに付与された米国特許第７，１９５，６２３号
バイアルアダプタという標題のSullivanらに付与された米国特許第７，６１５，０４１号
容器のためのプラグデバイス、および、１つのそのようなデバイスを有する容器という標題のAneasに付与された米国特許第８，２２５，９４９号
医療デバイスコネクタという標題のNordらに付与された米国特許第８，４８０，６４６号
復元デバイスという標題のTuckwellらに付与された米国特許第８，５６２，５８２号
装置および方法という標題の米国特許出願公開第２０１２／０３１０２０３号
デバイスという標題の米国特許出願公開第２０１３／００５３８１４号
頂部が開口した薬剤容器と、そこに取り付けられる薬剤容器閉鎖体と、を備える使用準備ができた薬剤復元組立体を改善することが求められる。
本発明は、頂部が開口した薬剤容器に取り付けて、ニードルレス注射器とともに使用するためのいわゆる使用準備ができた薬剤復元組立体を形成するための薬剤容器閉鎖体を対象としている。
薬剤容器閉鎖体は、以下の３つの主要な構成要素、すなわち、頂部が開口した薬剤容器にしっかりと取り付けるための閉鎖体ハウジングと、薬剤容器をシールするために閉鎖体ハウジングにしっかりと取り付けられる薬剤容器ストッパと、閉鎖体ハウジングに摺動的に取り付けられる流体移送部材と、を備えている。流体移送部材は、薬剤容器ストッパを穿刺するとともにニードルレス注射器コネクタに流れ連通するための穿刺カニューレと一体的に形成されたニードルレス注射器コネクタを備えている。
閉鎖体ハウジングは、好ましくは、初期の非穿刺位置から最終的な穿刺位置まで流体移送部材を下方に移動させて案内するための直径方向の逆Ｌ字状のトラック対を備えている。あるいは、閉鎖体ハウジングは、単一の逆Ｌ字状のトラック、または、３つ以上の逆Ｌ字状のトラックを有するように構成されてもよい。
逆Ｌ字状のトラックは、その初期の非穿刺位置からその最終的な穿刺位置まで流体移送部材を次のように案内するための２つの動作を行うことをユーザに求めるように構成されている。まず、動作準備のできた薬剤復元組立体を準備するために最初に時計回りに僅かに回転させ、続いて、薬剤容器ストッパを穿刺するために大きく変位動作させる。逆Ｌ字状のトラックによって、不注意によって事前穿刺することが生じない安全な経路が確保される。逆Ｌ字状のトラックは、ユーザが流体移送部材を以前の位置に戻すことを防止し、それによって、証拠改ざんを諦めさせるための一方向スナップ部材を備えている。また、一方向スナップ部材は、次のユーザ動作に進むことを表すための可聴式のユーザ表示を提供する。
薬剤容器閉鎖体は、開口または閉口した逆Ｌ字状のトラックを有する閉鎖体ハウジングを有していてもよい。開口した逆Ｌ字状のトラックには、下方に垂下する穿刺カニューレを密封シールするための追加的なシースが必要となる。閉口した逆Ｌ字状のトラックには、開口したトラックをシールし、それによって、追加的なシースが必要なくなるようにするための、閉鎖体ハウジングの外部に取り付けられる追加的なスリーブが必要になる。
流体移送部材は、通気式、または、非通気式で提供され得る。ニードルレス注射器コネクタは、雌ルアーコネクタとして形成されてもよい。ニードルレス注射器コネクタは、液剤内容物を複数吸引するための、掃除することができる自己シール式ポートとして形成されてもよい。
本発明を理解し、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。
ニードルレス注射器とともに使用するための初期非穿刺位置にある、本発明にしたがった薬剤復元組立体の第１実施形態の図である。 図１の薬剤復元組立体の隠された正面図である。 図１の薬剤復元組立体の上面図である。 図３のＡ−Ａ線に沿った図１の薬剤復元組立体の縦断面図である。 図３のＢ−Ｂ線に沿った図１の薬剤復元組立体の縦断面図である。 図１の薬剤復元組立体の分解正面図である。 図６のＣ−Ｃ線に沿った図１の薬剤復元組立体の縦断面図である。 一体型のニードルレス注射器コネクタおよび穿刺カニューレを有する図６の流体移送部材の正面図である。 線Ｄ−Ｄに沿った図８の流体移送部材の縦断面図である。 図１の薬剤容器閉鎖体の閉鎖体ハウジングおよび薬剤容器ストッパの縦断面図である。 初期非穿刺位置にある図１の薬剤容器閉鎖体の縦断面図である。 動作の用意ができた準備位置に押圧されている図１の薬剤容器閉鎖体の縦断面図である。 最終穿刺位置にある図１の薬剤容器閉鎖体の縦断面図である。 図１の薬剤復元組立体の使用方法を示している。 図１の薬剤復元組立体の使用方法を示している。 図１の薬剤復元組立体の使用方法を示している。 初期非穿刺位置にある、本発明にしたがった薬剤復元組立体の第２実施形態の正面図である。 Ｅ−Ｅ線に沿った図１５の薬剤復元組立体の縦断面図である。
図１は、生理学的流体源を構成するニードルレス注射器１０とともに使用するための、使用準備ができた薬剤復元組立体１００を示している。薬剤復元組立体１００は、頂部が開口した薬瓶によって構成される頂部が開口した薬剤容器２０と、そこにしっかりと固定される薬剤容器閉鎖体３０と、を備えている。頂部が開口した薬剤容器２０は、代替的に、粉末薬剤または液体薬剤を収容するための他の医療用容器によって構成されていてもよい。
注射器１０は、プランジャ１２と雄ルアーロックコネクタ１３とを有するバレル１１を備えている。注射器１０は、他のタイプの雄コネクタによって形成されていてもよい。注射器１０は、液体内容物１４で満たされている。液体内容物１４は、希釈剤のみであってもよい。あるいは、液体内容物１４は、活性成分を含有していてもよい。
図２は、頂部が開口した薬瓶２０を示している。この頂部が開口した薬瓶２０は、長手方向軸線２１を有し、薬瓶ショルダ２２と、薬瓶リム２３と、中間の薬瓶幅狭ネック２４と、を備えている。薬瓶リム２３は、薬瓶開口２６を形成する。薬瓶２０は、粉末状または液体の薬剤２７を収容する。
図２〜１３は、薬剤容器閉鎖体３０を示している。この薬剤容器閉鎖体３０は、長手方向中心線３１と、薬瓶２０にしっかりとスナップ嵌め取り付けするための閉鎖体ハウジング３２と、薬瓶開口２６をシールするための薬剤容器ストッパ３３と、を備えている。閉鎖体ハウジング３２は、初期の非穿刺位置から薬剤容器ストッパ３３を穿刺するための最終的な穿刺位置まで摺動的に移動できる流体移送部材３４を収容する。流体移送部材３４は、一体型のニードルレス注射器コネクタ３６と、注射器コネクタ３６に流れ連通する穿刺カニューレ３７と、を備えている。ニードルレス注射器コネクタ３６は、雄コネクタ１３をそこにねじ取り付けするための掃除することができる雌ルアーコネクタとして形成されている。薬剤容器閉鎖体３０は、ニードルレス注射器コネクタ３６をシールするための閉鎖体キャップ３８を備えている。
閉鎖体ハウジング３２は、適切なプラスチック材料から製造され、その初期の非穿刺位置からその最終的な穿刺位置まで流体移送部材３４の移動動作を案内するための直径方向の逆Ｌ字状トラック対３９を備えている。薬剤容器閉鎖体３０は、直径方向の逆Ｌ字状トラック対３９をシールして穿刺カニューレ３７の無菌状態を確保するために閉鎖体ハウジング３２の外部にスリーブ４１を備えている。スリーブ４１は、使用準備ができた薬剤復元組立体１００の組立中に薬剤容器閉鎖体３０を薬瓶２０上に下方に押し下げる際に、薬瓶リム２３にスナップ嵌めするためのスナップ嵌め部材４２を備えている。
流体移送部材３４は、円形のベース部材４３を備えている。ベース部材４３は、ニードルレス注射器コネクタ３６および穿刺カニューレ３７とともに形成されている。ベース部材４３は、流体移送部材３４の移動動作を案内するための直径方向の逆Ｌ字状トラック対３９に沿って移動するために、直径方向外側に向けられたピン対４４を備えている。流体移送部材３４は、オプションとして、通気式バイアルアダプタを有する液剤移送デバイスという標題の本願出願人の国際公開ＷＯ２０１１／１０４７１２に開示されているように、通気構造４６を備えていている。
閉鎖体ハウジング３２は、上側横断部材４７Ａと下側横断部材４７Ｂとを有する横断部材４７を備えている。横断部材４７は、穿刺カニューレ３７の通路のための中央開口４８を有して形成されている。下側横断部材４７Ｂは、薬剤容器ストッパ３３と一体的に形成されている。横断部材４７および薬剤容器ストッパ３３は、一緒にオーバーモールドされていてもよい。あるいは、横断部材４７は、機械的手段、かしめ、接着などによって薬剤容器ストッパ３３に取り付けられていてもよい。
逆Ｌ字状トラック３９の各々は、長手方向中心線３１と同一方向の、端部が開口した直立したアクセスレッグ４９と、長手方向中心線３１と交差する方向の水平準備レッグ５１と、長手方向中心線３１と同一方向の直立する動作レッグ５２と、を備えている。主要な部分である直立する動作レッグ５２は、動作レッグ基端５２Ａと、準備レッグ５１に対応して隣接するとともに準備レッグ５１よりも先端側の動作レッグ先端５２Ｂと、有している。
また、逆Ｌ字状トラック３９の各々は、３つの一方向スナップ部材を次のように備えている。
１つ目の一方向保持スナップ部材５３は、端部が開口した直立するアクセスレッグ４９と水平準備レッグ５１との連結部５４のところにある。一方向保持スナップ部材５３は、使用前に流体移送部材３４を閉鎖体ハウジング３２内に保持する。
２つ目の準備スナップ部材５６は、水平準備レッグ５１と動作レッグ基端５２Ａとの間の連結部５７のところにある。
３つ目の一方向動作スナップ部材５８は、動作レッグ先端５２Ｂのところにある。
図１１は、使用前の、その初期のセットアップ位置にある流体移送部材３４を示している。外側に向けられたピン対４４は、一方向保持スナップ部材対５３を越えて、一方向準備スナップ部材対５６の手前に、水平準備レッグ対５１に沿って配置されている。穿刺カニューレ３７は、薬剤容器ストッパ３３を穿刺するために、中央開口４８の上方において適所に配置されている。
図１２は、流体移送部材３４が、動作準備ができた動作レッグ基端対５２Ａのところで、一方向準備スナップ部材対５６を越えて、その準備位置まで押圧されている状態を示している。この位置は、外側に向けられたピン対４４が一方向準備スナップ部材対５６を越えてスナップされるまで、ユーザが、ニードルレス注射器１０を薬剤復元組立体１００にねじ取り付けして、時計回りの締める方向に回転させることによって可能になる。ユーザには、ユーザが動作を進めてもよいことを表すために、外側に向けられたピン対４４が一方向準備スナップ部材対５６を越えてスナップされたときに、カチッという音が聞こえる。穿刺カニューレ３７は、薬剤容器ストッパ３３を穿刺するために、中央開口４８の上方において適所に配置されたままである。一方向準備スナップ部材対５６によって、流体移送部材３４が水平準備レッグ対５１まで戻されることが防止される。
図１３は、動作レッグ先端対５２Ｂのところでその動作位置にある流体移送部材３４を示している。この位置は、外側に向けられたピン対４４が一方向動作スナップ部材対５８を越えてスナップされるまで、ユーザがニードルレス注射器１０を薬瓶２０に向けて押し下げることによって可能になる。ユーザには、外側に向けられたピン対４４が一方向動作スナップ部材対５８を越えてスナップされたときに、ユーザが薬剤の復元および投与を進めてもよいことを表すカチッという音が聞こえる。一方向動作スナップ部材対５８によって、流体移送部材３４が以前の位置まで戻されることが防止される。
薬剤復元組立体１００の使用方法について図１４Ａ〜１４Ｃを参照して以下に説明する。
図１４Ａは、図１１に示されるような使用前にそのセットアップ位置にある薬剤復元組立体１００を示している。ユーザは、閉鎖体キャップ３８を薬剤復元組立体１００から取り外して、ニードルレス注射器コネクタ３６を露出させる。
図１４Ｂは、ユーザがニードルレス注射器１０を矢印Ａによって示される時計回り方向に回してニードルレス注射器コネクタ３６にねじ取り付けして、最初に注射器１０をシールし、続いて、図１２に示されるように流体移送部材３４を動作レッグ基端対５２Ａのところで停止させる様子を示している。ユーザには、薬剤復元組立体１００が動作準備されていることを表すために、流体移送部材３４が一方向準備スナップ部材対５６を越えたときに、カチッという音が聞こえる。
図１４Ｃは、ユーザが流体移送部材３４を矢印Ｂで示されるように動作レッグ５２に沿って下方に向けて押して、図１３に示されるように動作レッグ先端対５２Ｂのところで停止される様子を示している。この移動によって、穿刺カニューレ３７は薬剤容器ストッパ３３を貫通穿刺する。ユーザには、ユーザが薬剤の復元および投与を進めてもよいことを表すために、流体移送部材３４が一方向動作スナップ部材対５８を越えたときに、カチッという音が聞こえる。
図１５および図１６は、構成および動作が、使用準備ができた薬剤復元組立体１００と類似しており、したがって、同様の部分には同様の符号が付された、使用準備ができた薬剤復元組立体２００を示している。薬剤復元組立体２００は、薬剤復元組立体２００がスリーブ４１を有しておらず、したがって、その閉鎖体ハウジング３２が、スナップ嵌め部材４２とともに形成され、直径方向に開口した逆Ｌ字状トラック対３９を有している点において、薬剤復元組立体１００と異なっている。薬剤復元組立体２００は、無菌状態を確保するために穿刺カニューレ３７に配置されるシース６１を備えている。シース６１は、裂かれて、流体移送部材３４をその最終的な穿刺位置まで下方に移動させる際に上側横断部材４８Ｂに当接して上方に押圧される。
本発明を限られた数の実施例に関して説明したが、本発明の多くの変形、変更および他の用途が、添付の特許請求の範囲内で可能であることが理解されよう。
１０…ニードルレス注射器
１１…バレル
１２…プランジャ
１３…雄コネクタ
１４…液体内容物
２０…薬剤容器
２１…長手方向軸線
２２…薬瓶ショルダ
２３…薬瓶リム
２４…薬瓶幅狭ネック
２６…薬瓶開口
２７…薬剤
３０…薬剤容器閉鎖体
３１…長手方向中心線
３２…閉鎖体ハウジング
３３…薬剤容器ストッパ
３４…流体移送部材
３６…ニードルレス注射器コネクタ
３７…穿刺カニューレ
３８…閉鎖体キャップ
３９…逆Ｌ字状トラック対
４１…スリーブ
４２…スナップ嵌め部材
４３…ベース部材
４４…ピン
４６…通気構造
４７…横断部材
４７Ａ…上側横断部材
４７Ｂ…下側横断部材
４８…中央開口
４９…アクセスレッグ
５１…水平準備レッグ
５２…動作レッグ
５２Ａ…動作レッグ基端
５２Ｂ…動作レッグ先端
５３…一方向保持スナップ部材
５４…連結部
５６…一方向準備スナップ部材
５７…連結部
５８…一方向動作スナップ部材
６１…シース
１００，２００…薬剤復元組立体

Claims (4)

  1. 頂部が開口した薬剤容器に取り付けて、ニードルレス注射器とともに使用するための使用準備ができた薬剤復元組立体を形成するための薬剤容器閉鎖体であって、
    前記頂部が開口した薬剤容器は、薬剤容器開口を形成する薬剤容器リムを備え、
    前記薬剤容器閉鎖体は、長手方向中心線を有し、
    前記薬剤容器閉鎖体は、
    （ａ）前記薬剤容器リムにしっかりと取り付けるためのチューブ状の閉鎖体ハウジングを備え、
    前記閉鎖体ハウジングは、端部が開口した直立アクセスレッグと、水平準備レッグと、直立動作レッグと、を有する少なくとも１つの逆Ｌ字状トラックを備え、
    前記動作レッグは、動作レッグ基端と、前記準備レッグに対応して隣接するとともに該準備レッグに対して先端側にある動作レッグ先端と、を有し、
    前記逆Ｌ字状トラックの各々は、
    ｉ）前記端部が開口した直立アクセスレッグと前記水平準備レッグとの間にある一方向保持スナップ部材であって、該一方向保持スナップ部材の先端が、前記動作レッグ基端よりも、前記水平準備レッグの前記動作レッグ基端と反対側に配置された一方向保持スナップ部材と、
    ｉｉ）前記水平準備レッグと前記動作レッグ基端との間にある一方向準備スナップ部材であって、該一方向準備スナップ部材の先端が、前記端部が開口した直立アクセスレッグよりも前記動作レッグ基端側に配置された一方向準備スナップ部材と、
    ｉｉｉ）前記動作レッグ先端に向かう一方向動作スナップ部材であって、前記一方向動作スナップ部材の先端が、前記動作レッグ基端よりも前記動作レッグ先端側に配置された一方向動作スナップ部材と
    を有し、
    前記薬剤容器閉鎖体は、
    ｂ）前記閉鎖体ハウジングを前記薬剤容器リムにしっかりと取り付ける際に前記薬剤容器開口をシールするために、前記閉鎖体ハウジングにしっかりと取り付けられる薬剤容器ストッパと、
    ｃ）前記ニードルレス注射器を取り付けるための一体型のニードルレス注射器コネクタと、前記薬剤容器ストッパを穿刺するための、前記ニードルレス注射器コネクタに流れ連通する穿刺カニューレと、を有する流体移送部材と
    を備え、
    前記流体移送部材は、前記流体移送部材を前記長手方向中心線に対して手動回転させる際に、前記水平準備レッグの各々に沿って該水平準備レッグに最初に配置され、
    前記流体移送部材は、前記薬剤容器と流体連通するために前記薬剤容器ストッパを穿刺するために前記一方向動作スナップ部材の各々を越えて前記動作レッグ先端の各々まで手動で押圧される前に、前記一方向準備スナップ部材の各々を越えて前記動作レッグ基端の各々まで押圧される
    薬剤容器閉鎖体。
  2. 請求項１に記載の薬剤容器閉鎖体であって、
    さらに、前記逆Ｌ字状トラックの各々をシールして前記穿刺カニューレの無菌状態を確保するために、前記閉鎖体ハウジングの外部にスリーブを備える
    薬剤容器閉鎖体。
  3. 請求項１に記載の薬剤容器閉鎖体であって、
    さらに、前記穿刺カニューレにシースを備える
    薬剤容器閉鎖体。
  4. 使用準備ができた薬剤復元組立体であって、
    頂部が開口した薬剤容器と、
    前記薬剤容器に取り付けられる、請求項１ないし請求項３のいずれか一項に記載の薬剤容器閉鎖体と
    を備える薬剤復元組立体。
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IL241889B (en) 2019-02-28
CN105120826B (zh) 2016-09-21
IL225734A0 (en) 2013-09-30
US20160051446A1 (en) 2016-02-25
DK2986267T3 (en) 2017-09-11
JP2016515439A (ja) 2016-05-30
BR112015025847B1 (pt) 2021-02-23
CN105120826A (zh) 2015-12-02
EP2986267A1 (en) 2016-02-24
BR112015025847A2 (pt) 2017-07-25

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