JP7137620B2 - 通気式雌型瓶アダプターの対を含む二重瓶アダプター集合体 - Google Patents

通気式雌型瓶アダプターの対を含む二重瓶アダプター集合体 Download PDF

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JP7137620B2
JP7137620B2 JP2020518440A JP2020518440A JP7137620B2 JP 7137620 B2 JP7137620 B2 JP 7137620B2 JP 2020518440 A JP2020518440 A JP 2020518440A JP 2020518440 A JP2020518440 A JP 2020518440A JP 7137620 B2 JP7137620 B2 JP 7137620B2
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デネンバーグ・イゴール
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Description

本発明は、薬剤が入った薬瓶、および液体が入った液瓶と共に使用される二重瓶アダプター集合体に関する。
二重瓶アダプター集合体は、薬剤が入った薬瓶、および液体が入った液瓶と共に使用される。液体は薬瓶の中の薬剤と混ざって、またはその薬剤を戻して液状の薬を形成する。二重瓶アダプター集合体は薬瓶アダプターと液瓶アダプターとを含む。薬瓶アダプターは薬瓶の上に伸縮自在に取り付けられ、薬瓶と連通する。液瓶アダプターは液瓶の上に伸縮自在に取り付けられ、液瓶と連通する。二重瓶アダプター集合体は一般に2つのタイプに分類可能である。負圧タイプは負圧下の薬瓶と共に使用されるものであり、液瓶から液体が薬瓶の中へ確実に引き込まれる。重力流タイプは、液瓶から薬瓶へ液体が重力によって流れるように配置された通気口を使用するものである。前者のタイプは、まず液瓶の上に伸縮自在に取り付けられ、次に薬瓶の上に伸縮自在に取り付けられる。前者のタイプは一般に、液状の薬を少量用意する際に使用される。後者のタイプは、液瓶と薬瓶とへの取り付けに特定の順序を必要としない。後者のタイプは一般に、液状の薬を多量に用意する際に使用される。これにより、液状の薬を数回に分けて吸引させるのに、または点滴用の静脈注射セットと共に使用するのに適している。
特許文献1には重力流タイプの二重瓶アダプター集合体の一例が開示されている。特許文献1の図9に示されている二重瓶アダプター集合体が含む薬瓶アダプターには雌型コネクターがあり、液瓶アダプターには管腔が二重で端が2つの輸液スパイクがある。このスパイクは液瓶の栓と薬瓶の栓との両方を貫通している。薬瓶の中に液状の薬を作ることにより、無針注射器を薬瓶アダプターに取り付けて、そこから液状の薬を無針注射器に吸引させることを可能にするには、使用者は薬瓶アダプターと液瓶アダプターとを正しく区別しなければならない。しかし、薬瓶アダプターと液瓶アダプターとは非常に似ているので混同を招きやすく、液状の薬を液瓶の中に作ってしまいかねない。この場合、上記の輸液スパイクがある液瓶アダプターに無針注射器を取り付けることはできない。
特許文献2には別の二重瓶アダプター集合体が開示されている。図1-図5には通気式雌型薬瓶アダプターと通気式雄型液瓶アダプターとが開示されている。図6-図8には、同一の通気式雌型瓶アダプターが2つと、中間に位置する端が2つの輸液カプラーとが開示されている。この輸液カプラーには、方向が互いに反対である1対の雄型コネクターがある。図9-図11には、同一の通気式雄型瓶アダプターが2つと、中間に位置する端が2つの輸液カプラーとが開示されている。この輸液カプラーには、方向が互いに反対である1対の雌型コネクターがある。これらの二重瓶アダプター集合体には同一の通気式瓶アダプターが2つあるので、次の利点がある。いずれの通気式瓶アダプターを薬瓶または液瓶の上に取り付けても等価であるので、使用者は薬瓶アダプターと液瓶アダプターとを区別する必要がない。通気式瓶アダプターは、好ましくは特許文献3に開示されているように、瓶から速やかに取り外されるように設計されている。したがって、通気式瓶アダプターは、液状の薬が入った薬瓶から簡単に取り外すことができる。これにより、その薬瓶の栓を露出させて、液状の薬を患者に点滴するための静脈注射セットに挿入することができる。
二重瓶アダプター集合体において、薬瓶の中に液状の薬を形成するために、液瓶から薬瓶へ生じさせる重力による流れを改善する必要がある。
米国特許第8752598号明細書 国際公開第2017/203512号 国際公開第2012/150587号
本発明は二重瓶アダプター集合体を対象とする。この集合体は次のような3つの構成要素を含む。薬瓶の上に伸縮自在に取り付けられた第1通気式雌型瓶アダプター、液瓶の上に伸縮自在に取り付けられた第2通気式雌型瓶アダプター、および、第1通気式雌型瓶アダプターと第2通気式雌型瓶アダプターとを連結させて、それらの間で二重に密封された管腔構造を成す管状の輸液カプラー。この管腔構造には、密封された液体用中央管腔と、それよりも外周側に位置する、少なくとも1つの密封された空気用管腔とが含まれる。液体用中央管腔では液瓶から、その下に配置された薬瓶まで、液体が重力によって流れる。空気用管腔では薬瓶から液瓶へ変位した空気が排気される。液瓶と薬瓶との間で閉じたシステムが形成されることにより、重力による液体の流れが促される。輸液カプラーは好ましくは、空気用管腔が液体用中央管腔を同軸に囲むように設計されている。本発明の二重瓶アダプター集合体は好ましくは、適切に無菌状態とされた梱包から解かれたらすぐに使えるように設定された位置にある。その他に、二重瓶アダプター集合体は、使用前に使用者が組み立てなければならないものであってもよい。
発明を理解し、発明が実際にどのように実施可能であるかを見る目的で、以下、好ましい実施形態について、非限定的な例のみを用いて説明する。参照される添付の図面では、同様な部分に同様な参照番号が付されている。
投与セットの斜視図である。このセットには、無針注射器、薬瓶、液瓶、点滴セット、および、本発明の好ましい第1実施形態による二重瓶アダプター集合体が含まれる。 図1の二重瓶アダプター集合体の分解図である。 図1の直線A-Aに沿った図1の二重瓶アダプター集合体の縦断面図である。 液瓶から薬瓶への液体の流れと、薬瓶から液瓶への空気の変位とを示す、図1の直線A-Aに沿った図1の二重瓶アダプター集合体の縦断面図である。 投与セットの使用方法を示す。 本発明の好ましい第2実施形態による二重瓶アダプター集合体の斜視図である。 図6の二重瓶アダプター集合体の分解図である。 図6の二重瓶アダプター集合体の輸液カプラーの上面図である。 図8Aの直線C-Cに沿った図6の輸液カプラーの縦断面図である。 図8Aの直線D-Dに沿った図6の輸液カプラーの縦断面図である。 図8Aの直線D-Dに沿った図6の二重瓶アダプター集合体の縦断面図である。
図1は投与セット5を示す。このセット5は、最初は空である無針注射器10、薬瓶20、液瓶30、点滴セット40(寸法が縮小されている。)、および二重瓶アダプター集合体100を含む。無針注射器10はシリンダ11を含み、シリンダ11はプランジャー12と雄型のルアーロックコネクター13とを含む。注射器10は他のタイプの雄型コネクターで形成されていてもよい。薬瓶20には長手方向に軸20Aがある。薬瓶20は上端が開いたボトル21を含む。ボトル21は王冠部22と、径の狭い首部23とを含む。薬瓶の王冠部22は栓24によって密封されている。薬瓶の栓24はアルミニウムの帯26によって密封されている。薬瓶20には薬剤27が入っている。薬剤27は、粉状、固体状、または液状である。液瓶30には長手方向に軸30Aがある。液瓶30は上端が開いたボトル31を含む。ボトル31は王冠部32と、径の狭い首部33とを含む。液瓶の王冠部32は栓34によって密封されている。液瓶の栓34はアルミニウムの帯36によって密封されている。液瓶30には液体37が入っている。液体37は希釈剤だけであっても、活性成分が混ざっていてもよい。静脈注射用点滴セット40は、静脈注射用スパイク41、第1管42、クランプ43、滴下室44、第2管46、ローラークランプ47、雄型のルアーコネクター48、およびルアーシールド49を含む。第1管42は典型的な寸法が4.1mm×200mmであり、第2管46は典型的な寸法が4.1mm×500mmである。
図2-図4が示すように、二重瓶アダプター集合体100には、長手方向に伸びる中心線101がある。二重瓶アダプター集合体100は次の3つの構成要素を含む。第1通気式雌型瓶アダプター110は薬瓶20の上に伸縮自在に取り付けられている。第2通気式雌型瓶アダプター120は液瓶30の上に伸縮自在に取り付けられている。管状の輸液カプラー130は第1通気式雌型瓶アダプター110と第2通気式雌型瓶アダプター120とを連結している。
第1通気式雌型瓶アダプター110には、長手方向に伸びる中心線111がある。第1通気式雌型瓶アダプター110は、横方向に広がる第1上壁112を含む。第1上壁112には、第1直立雌型コネクター113と、直径方向で対を成す第1通気口112Aとがある。第1通気式雌型瓶アダプターの中心線111に対し、第1通気口112Aは第1直立雌型コネクター113よりも外周側に位置する。第1直立雌型コネクター113は好ましくは、雄ねじを含む雌型のルアーコネクターで構成されている。その雄ねじには雄型のルアーロックコネクターがねじ込まれる。第1通気式雌型瓶アダプター110は第1スカート114と環状の空気フィルター室116とを含む。第1スカート114は薬瓶20の上に伸縮自在に取り付けられている。空気フィルター室116は第1上壁112と第1スカート114との間に配置されている。空気フィルター室116は環状の空気フィルター116Aを含む。
第1上壁112は、環状である内側の囲い117を含む。内側の囲い117は、第1通気式雌型瓶アダプターの中心線111に対して第1通気口112Aよりも外周側に位置する。第1上壁112は、環状である外側の囲い118を含む。外側の囲い118が内側の囲い117の近くで内側の囲い117を囲むことにより、それらの囲いの間には環状の溝が形成されている。内側の囲い117には、外側の囲い118に面した外周シール面117Aがある。外側の囲い118は、互いに対向する1対の結合用の溝118Aを含む。内側の囲い117と外側の囲い118とは必ずしも環状でなくてもよいが、第1通気式雌型瓶アダプターの中心線111に対して、第1通気口112Aよりも外周側に位置しなければならない。
第1スカート114は第1管119を含む。第1管119は、第1通気式雌型瓶アダプター110を薬瓶20の上に伸縮自在に取り付けている薬瓶の栓24を貫通している。第1管119は液体用管腔119Aと空気用管腔119Bとを含む。液体用管腔119Aは第1通気式雌型瓶アダプターのコネクター113に連通している。空気用管腔119Bは第1通気口112Aに連通している。
第2通気式雌型瓶アダプター120には、長手方向に伸びる中心線121がある。第2通気式雌型瓶アダプター120は、横方向に広がる第2上壁122を含む。第2上壁122には、第2直立雌型コネクター123と、直径方向で対を成す第2通気口122Aとがある。第2通気式雌型瓶アダプターの中心線121に対し、第2通気口122Aは第2直立雌型コネクター123よりも外周側に位置する。第2直立雌型コネクター123は好ましくは、雄ねじを含む雌型のルアーコネクターで構成されている。その雄ねじには雄型のルアーロックコネクターがねじ込まれる。第2通気式雌型瓶アダプター120は第2スカート124と環状の空気フィルター室126とを含む。第2スカート124は液瓶30の上に伸縮自在に取り付けられている。空気フィルター室126は第2上壁122と第2スカート124との間に配置されている。空気フィルター室126は環状の空気フィルター126Aを含む。
第2上壁122は、環状である内側の囲い127を含む。内側の囲い127は、第2通気式雌型瓶アダプターの中心線121に対して第2通気口122Aよりも外周側に位置して、第2直立雌型コネクター123を囲んでいる。第2上壁122は、環状である外側の囲い128を含む。外側の囲い128が内側の囲い127の近くで内側の囲い127を囲むことにより、それらの囲いの間には環状の溝が形成されている。内側の囲い127には、外側の囲い128に面した外周シール面127Aがある。外側の囲い128は、互いに対向する1対の結合用の溝128Aを含む。内側の囲い127と外側の囲い128とは必ずしも環状でなくてもよいが、第2通気式雌型瓶アダプターの中心線121に対して、第2通気口122Aよりも外周側に位置しなければならない。
第2スカート124は第2管129を含む。第2管129は、第2通気式雌型瓶アダプター120を液瓶30の上に伸縮自在に取り付けている液瓶の栓34を貫通している。第2管129は液体用管腔129Aと空気用管腔129Bとを含む。液体用管腔129Aは第2通気式雌型瓶アダプターのコネクター123に連通している。空気用管腔129Bは第2通気口122Aに連通している。
第1通気式雌型瓶アダプター110と第2通気式雌型瓶アダプター120とは好ましくは、特許文献3に開示された、手早く取り外せるタイプである。
輸液カプラー130には、長手方向に伸びる中心線131がある。輸液カプラー130は、第1通気式雌型瓶アダプター110に結合した第1端130Aと、第2通気式雌型瓶アダプター120に結合した第2端130Bとを含む。これらの端が結合することにより二重瓶アダプター集合体100の各部の位置が設定される。輸液カプラー130は空気用管腔壁132と外壁133とを含む。外壁133は、径方向に広がる羽根134で空気用管腔壁132に取り付けられている。外壁133は第1上壁112の周囲と第2上壁122の周囲との間に広がっており、二重瓶アダプター集合体100を取り扱うのに役立つ。空気用管腔壁132は、横方向に広がる環状の内部フランジ136を含む。内部フランジ136は第1直立雄型コネクター137Aと、それとは反対方向の第2直立雄型コネクター137Bとを含む。第1直立雄型コネクター137Aは第1直立雌型コネクター113に挿入され、その中を密封する。第2直立雄型コネクター137Bは第2直立雌型コネクター123に挿入され、その中を密封する。
空気用管腔壁132は、互いに対向する1対の結合用突起132A、132Bを含む。結合用突起の一方132Aは輸液カプラーの第1端130Aから外周方向へ突出して、結合用の溝118Aと結合する。結合用突起のもう一方132B(図示せず。)は輸液カプラーの第2端130Bから外周方向へ突出して、結合用の溝128Aと結合する。こうして、二重瓶アダプター集合体100の各部の位置が設定される。このとき、空気用管腔壁132は、輸液カプラーの第1端130Aでは内側の囲い117と外側の囲い118との間に滑り込み、輸液カプラーの第2端130Bでは内側の囲い127と外側の囲い128との間に滑り込む。空気用管腔壁132は、輸液カプラーの第1端130Aでは外周シール面117Aを密封し、輸液カプラーの第2端130Bでは外周シール面127Aを密封している。
二重瓶アダプター集合体100の各部の位置が設定されると、輸液カプラー130は二重に密封された管腔構造138を構成する。この構造138は、密封された液体用中央管腔138Aと、密封された空気用管腔138Bとを含む。液体用中央管腔138Aは第1直立雌型コネクター113と第2直立雌型コネクター123との間に位置している。空気用管腔138Bは液体用中央管腔138Aを囲んでおり、第1通気口112Aと第2通気口122Aとを気密に連通させている。このように、二重瓶アダプター集合体100は液瓶と薬瓶との間に閉じたシステムを形成し、液瓶から薬瓶へ液体が重力によって流れるのを促す。図4は、重力によって液瓶30から薬瓶20へ、密封された液体用管腔138Aを通して流れる液体を示す。この流れは矢印Aで示されている。図4は、薬瓶20から液瓶30へ、空気用管腔119B、密封された空気用管腔138B、および空気用管腔129Bを通して変位する空気の流れも示す。この流れは矢印Bで示されている。
図5A-図5Fは投与セット5の使用方法を示す。投与セット5は、患者へ投与すべき液状の薬を薬瓶20の中に用意するためのものである。図5Aは、第2通気式雌型瓶アダプター120を液瓶30の上に伸縮自在に取り付けて液瓶30に連通させる様子を示す。図5Bは、二重瓶アダプター集合体100を液瓶30と共にひっくり返し、第1通気式雌型瓶アダプター110を薬瓶20の上に伸縮自在に取り付けて薬瓶20に連通させる様子を示す。これにより、液瓶30から薬瓶20へ液体が重力によって流れて、薬瓶20の中で液状の薬が形成されると共に、薬瓶20から液瓶30へ空気が変位して排気される。図5Cは、輸液カプラー130が第1通気式雌型瓶アダプター110から取り外される様子を示す。図5Dは、第1通気式雌型瓶アダプター110に注射器10がねじ込まれ、患者へ投与すべき量の液状の薬を薬瓶20から吸引する様子を示す。図5Eは、第1通気式雌型瓶アダプター110を薬瓶20から取り外す様子を示す。図5Fは、静脈注射用点滴セット40を薬瓶20に接続して、患者に液状の薬を点滴する様子を示す。
図6-図9は、二重瓶アダプター集合体100と構成および操作が同様な二重瓶アダプター集合体200を示す。後者200は前者100とは、輸液カプラー130を第1通気式雌型瓶アダプター110と第2通気式雌型瓶アダプター120とに結合させる仕方が異なる。1対の結合用の溝118Aと結合用突起132A、および1対の結合用の溝128Aと結合用突起132Bが配置されるのではなく、空気用管腔壁132が、第1直立雌型コネクターに結合する第1雌ねじ139Aと、第2直立雌型コネクター123に結合する第2雌ねじ139Bとを含む。
本発明の特定の実施形態を図示して説明したが、発明の精神と範囲とから外れることなく様々な変更および修正が可能であることは、当業者には明らかであろう。

Claims (6)

  1. 薬瓶と液瓶と共に使用される二重瓶アダプター集合体であって、
    前記薬瓶は、ボトルと、当該ボトルを密封する栓とを含み、
    前記薬瓶には薬剤が入っており、
    前記液瓶は、ボトルと、当該ボトルを密封する栓とを含み、
    前記液瓶には、前記薬瓶の中の薬剤に混ぜられ、または当該薬剤を戻して液状の薬を前記薬瓶の中に形成するための液体が入っており、
    中心線が長手方向に伸びており、
    前記薬瓶の上に伸縮自在に取り付けられた第1通気式雌型瓶アダプターと、
    前記液瓶の上に伸縮自在に取り付けられた第2通気式雌型瓶アダプターと、
    前記第1通気式雌型瓶アダプターと前記第2通気式雌型瓶アダプターとの間で二重に密封された管腔構造を成す管状の輸液カプラーと
    を備え、
    (a)前記第1通気式雌型瓶アダプターでは、中心線が長手方向に伸びており、
    前記第1通気式雌型瓶アダプターは、
    i)第1直立雌型コネクター、および、長手方向に伸びる前記第1通気式雌型瓶アダプターの中心線に対して前記第1直立雌型コネクターよりも外周側に位置する少なくとも1つの第1通気口を含む、横方向に広がる第1上壁と、
    ii)前記薬瓶の上に伸縮自在に取り付けられた第1スカートと、
    iii)前記第1通気式雌型瓶アダプターが取り付けられた前記薬瓶の栓を貫通する、管腔が二重の第1貫通管と
    を含み、
    前記第1貫通管は、
    前記第1直立雌型コネクターに連通している第1液体用管腔と、
    前記少なくとも1つの第1通気口に連通している第1空気用管腔と
    を含み、
    (b)前記第2通気式雌型瓶アダプターでは、中心線が長手方向に伸びており、
    前記第2通気式雌型瓶アダプターは、
    i)第2直立雌型コネクター、および、長手方向に伸びる前記第2通気式雌型瓶アダプターの中心線に対して前記第2直立雌型コネクターよりも外周側に位置する少なくとも1つの第2通気口を含む、横方向に広がる第2上壁と、
    ii)前記液瓶の上に伸縮自在に取り付けられた第2スカートと、
    iii)前記第2通気式雌型瓶アダプターが取り付けられた前記液瓶の栓を貫通する、管腔が二重の第2貫通管と
    を含み、
    前記第2貫通管は、
    前記第2直立雌型コネクターに連通している第2液体用管腔と、
    前記少なくとも1つの第2通気口に連通している第2空気用管腔と
    を含み、
    (c)前記輸液カプラーでは、中心線が長手方向に伸びており、
    前記輸液カプラーは、
    前記第1通気式雌型瓶アダプターに連結している第1端と、
    前記第2通気式雌型瓶アダプターに連結している第2端と
    を含み、
    前記輸液カプラーは、
    前記少なくとも1つの第1通気口と前記少なくとも1つの第2通気口との間に、前記二重に密封された管腔構造のうち、密封された空気用管腔を構成している、長手方向に広がる空気用管腔壁
    を含み、
    前記空気用管腔壁は、
    前記第1直立雌型コネクターに挿入されてその中を密封する第1雄型コネクターと、
    前記第1雄型コネクターとは反対向きであって、前記第2直立雌型コネクターに挿入されてその中を密封する第2雄型コネクターと
    を含み、
    前記空気用管腔壁は、前記第1直立雌型コネクターと前記第2直立雌型コネクターとの間に、密封された液体用中央管腔を構成しており、
    前記密封された空気用管腔は、長手方向に伸びる前記輸液カプラーの中心線に対して前記密封された液体用中央管腔よりも外周側に位置し、
    前記第1通気式雌型瓶アダプターが前記薬瓶の上に取り付けられ、前記第2通気式雌型瓶アダプターが前記液瓶の上に取り付けられ、前記薬瓶の上方に前記液瓶が置かれて使用されることにより、前記液瓶から前記密封された液体用中央管腔を通して前記薬瓶へ重力によって流れる液体が前記密封された液体用中央管腔の中で液状の薬を形成することと、前記薬瓶から前記密封された空気用管腔を通して前記液瓶へ変位した空気が排気されることとが可能であり、
    続いて前記第1通気式雌型瓶アダプターを前記輸液カプラーから取り外すことにより、無針注射器を前記第1直立雌型コネクターに取り付けて、そこから液体を吸引させることが可能である
    ことを特徴とする二重瓶アダプター集合体。
  2. 前記第1上壁は、
    i)長手方向に伸びる前記第1通気式雌型瓶アダプターの中心線に対して前記少なくとも1つの第1通気口よりも外周側に位置し、前記第1直立雌型コネクターを囲んでいる内側の囲いと、
    ii)当該内側の囲いを囲んでいる外側の囲いと
    を含み、
    前記第2上壁は、
    i)長手方向に伸びる前記第2通気式雌型瓶アダプターの中心線に対して前記少なくとも1つの第2通気口よりも外周側に位置し、前記第2直立雌型コネクターを囲んでいる内側の囲いと、
    ii)当該内側の囲いを囲んでいる外側の囲いと
    を含み、
    前記空気用管腔壁は、前記輸液カプラーの第1端では前記第1上壁の内側の囲いと外側の囲いとの間に気密に挿入されており、前記輸液カプラーの第2端では前記第2上壁の内側の囲いと外側の囲いとの間に気密に挿入されている
    請求項1に記載の二重瓶アダプター集合体。
  3. 前記密封された空気用管腔は前記密封された液体用中央管腔を囲んでいる、請求項1または請求項2に記載の二重瓶アダプター集合体。
  4. 前記輸液カプラーは、
    前記空気用管腔壁に取り付けられており、前記二重瓶アダプター集合体の取り扱いを手助けする外壁
    を含む、請求項1から請求項3までのいずれか1項に記載の二重瓶アダプター集合体。
  5. 前記空気用管腔壁は、前記輸液カプラーの第1端では前記第1上壁と結合しており、前記輸液カプラーの第2端では前記第2上壁と結合している、請求項1から請求項4までのいずれか1項に記載の二重瓶アダプター集合体。
  6. 前記空気用管腔壁は、前記第1直立雌型コネクターに結合する第1雌ねじと、前記第2直立雌型コネクターに結合する第2雌ねじとを含む、請求項1から請求項4までのいずれか1項に記載の二重瓶アダプター集合体。
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