JP5535321B2 - 薬物送達システムのためのカートリッジ挿入アセンブリ - Google Patents
薬物送達システムのためのカートリッジ挿入アセンブリ Download PDFInfo
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Description
本発明は、一般的に薬物送達システム（例えば外部薬物ポンプ）に関し、特に、患者に投与される物質を収納しているカートリッジを薬物送達システムに挿入するためのアセンブリに関する。
外部薬物ポンプは、経口投与された場合に吸収され得ない巨大分子（例えばインスリン）を含んでいる物質を患者に投与するために、一般的に使用される。一般的に、上記ポンプは、患者の腹部、胸部または他の部分に付着させられ、患者の皮下に挿入されるカニューレを介して上記物質を患者に投与する。しかし、以下に説明されている本発明は、針による物質の投与に限定されない。
本発明は、患者に投与される物質を収納しているカートリッジを薬物ポンプ（または任意の種類の薬物送達システム）に挿入するための、改良されたアセンブリを提供することを目的としている。本発明のさらなる詳細は以下に説明されている。「カートリッジ」という用語は、患者に投与される物質のための任意の種類の貯蔵器または容器（使い捨てであるか、または使い捨てではない）（例えば、バイアル、アンプル、ボトルおよびあらかじめ充填されている注射器など）を包含しており、任意の大きさまたは形状に限定されないことが、留意される。
したがって、本発明の実施形態に従って提供されるのは、内部に形成された通路を有する装置、上記通路に挿入可能なカートリッジ、および当該装置に対して回転させられるドアを含んでいるカートリッジ挿入アセンブリである。上記カートリッジは、当該カートリッジに収納されている物質を、計量して当該カートリッジから排出させることが可能な上記装置に配置されている駆動手段と接続可能なカートリッジ連結要素を含んでいる。上記ドアはドア連結要素を含んでおり、当該ドア連結要素は、当該ドアが完全に閉じられているときに、上記カートリッジ連結要素を上記駆動手段の連結要素と連結させるように、上記カートリッジに対して配置されている。
本発明の実施形態において、固定ラッチが装置の底面から片持ち梁として突出しており、上記カートリッジが上記装置に完全に挿入されているとき、当該固定ラッチは、上記カートリッジのリムに沿って接触することによって、上記通路に上記カートリッジを固定する。
本発明の実施形態において、上記カートリッジが上記装置に完全に挿入されているとき、当該カートリッジは、当該装置に取り付けられているカートリッジストッパーに沿って接触する。
本発明の実施形態において、上記カートリッジは、上記カートリッジ連結要素に対して反対側の端部に隔壁を含んでおり、上記装置は中空の針を含んでおり、当該中空の針は、カートリッジが装置に完全に挿入されているとき、上記隔壁に穴を開ける。
本発明の実施形態において、上記ドアはその内部の表面上に閉鎖部材を含んでいる。上記閉鎖部材は１つ以上の傾いた傾斜部材を含んでいる。上記傾斜部材は、上記カートリッジ連結要素をスライドさせかつ押して、上記ドアの閉鎖によって上記カートリッジを上記装置内に完全に押し込む。
本発明の実施形態において、上記ドアは、１つ以上の突出部材を用いて形成されており、上記突出部材は、上記ドアが完全に閉じられているとき、上記装置に形成された１つ以上の対応している溝に受け入れられている。
本発明の実施形態において、上記閉鎖部材はハブを含んでおり、ドアが完全に閉じられているとき、上記ハブはスナップ部材に固定して受け入れられている。
本発明は、図面を用いた以下の詳細な説明からより正しく理解され、正しく評価される。
以下は図１および２に対する説明である。図１および２は、本発明の非限定的な実施形態に係る、物質（例えばインスリン）を対象に投与する装置１０を示している。装置１０は、対象に投与される物質を収納しているカートリッジ（図２）を一般的に備えている。図２は、カートリッジ挿入アセンブリの開放位置にあるドア１４、および装置１０における通路１５に挿入する状態のカートリッジ１２を示している。
図２に示されているように、カートリッジ１２は、駆動手段１８（図４に示されており、モーター、バッテリー、および制御ユニットを一般的に備えている）と連結させる（例えば、歯車のかみ合わせの）ための、カートリッジ連結要素１６（例えば歯車）を備えている（いくつかの実施形態において、カートリッジ連結要素１６は、駆動スクリュー（driving screw）の端部に取り付けられている）。上記駆動手段１８は、最終的な患者への投与の間に、カートリッジ１２に収納されている物質を計量しながらカートリッジ１２の外部に供給させる。駆動手段が機能して物質を計量してカートリッジ１２の外部に排出させる方法は、本発明には関連していない。一例として、上記駆動手段は、米国特許出願公開第２００９／００９３７９２号、米国特許出願公開第２００９／００９３７９３号または国際特許出願第ＰＣＴ／ＩＬ２００８／００１３１２号（国際公開２００９／０４４４０１号として公開）に記載されている種類の外部薬物ポンプとして動作する。しかし、本発明は、患者に対する針穿刺による投与だけでなく、経皮的な（薬物が装置１０によって計量されて経皮パッチに供給される）投与、噴射（薬物が装置１０に計量されて噴射ノズルに供給される）および微小針のアレイによる投与などの、薬物の適切な投与の任意の種類に使用され得、上記薬物ポンプに限定されない。
カートリッジ１２は一般的に使い捨てであるが、システムの電子機器、バッテリーおよびモーター、ならびに他の要素は、必要に応じて１回を超えて使用され得ることに注意すべきある。
図３に示されているように、本発明の非限定的な実施形態によれば、ドア１４は、ドア連結要素２０（例えば、歯車であるが、回転運動を伝達する任意の他の連結要素（例えば摩擦車）であり得る）を備えている。ドア結合要素２０は、さらなる詳細について以下に記載される通り、カートリッジ連結要素１６および駆動手段１８の連結要素２２（図２）の間の連結（例えば、かみ合わせ）のために、ドア１４に備えられている。
以下は図４に対する説明である。図４は、装置１０に部分的に挿入されたカートリッジ１２を図示しており、カートリッジ挿入アセンブリの構成要素を示している。カートリッジ１２は、カートリッジ連結要素１６の反対側の端部に隔壁２４を有している。隔壁２４が中空の針２６によって突き刺されて、カートリッジ１２の内容物は、患者に対して最終的に投与されるために、カートリッジ１２から針２６に流れ込み、針２６から出射口（図示せず）まで流れる。カートリッジストッパー２８は、剛体材料（例えばプラスチック）またはより好ましくは弾性材料（例えば、エストラマーまたはシリコン）によって作製され得る。カートリッジストッパー２８は、カートリッジ１２を装置１０に挿入するときに、カートリッジ１２の移動を停止させ、カートリッジ１２の過剰な挿入を防ぐために設けられている。また、カートリッジストッパー２８は、駆動手段１８によって生み出されてカートリッジの駆動スクリューを回転させるトルクによるカートリッジ１２の回転を、防止する。カートリッジストッパー２８は、カートリッジ１２の段部に沿って接触する。図５は、ドア１４が解放状態にある装置１０内にあるカートリッジストッパー２８まで完全に挿入されているカートリッジ１２を示している。
以下は図６および７に対する説明である。装置１０のカートリッジ挿入アセンブリは、装置１０の底面３３（図７）から片持ち梁として突出している固定ラッチ３２を備えている。カートリッジ１２を装置１０に挿入するとき、カートリッジ連結要素１６の近傍にあるリム３４は、固定ラッチ３２を押し下げ、固定ラッチ３２を越えてスライドする。カートリッジ１２が装置１０に完全に挿入されているとき、リム３４は固定ラッチ３２を通り過ぎて移動しており、固定ラッチ３２は、跳ね戻って、リム３４に沿って接触している。これによって、固定ラッチ３２はカートリッジ１２を適当な位置に固定する。ユーザは、装置１０からカートリッジ１２を取り外すことはできない。
以下は、ドア１４の内側を図示している図８に対する説明である。上述のドア連結要素２０は、ドア１４の内側の中央にある。要素２０から見た側方の一方には、装置１０の本体における対応するソケット３８（図１０参照）内に回転軸として（例えばスナップ式のはめ合わせによって）接続するヒンジ部材３６がある。要素２０から見た側方の他方には閉鎖部材４０があり、閉鎖部材４０は、ハブ４２および１つ以上の傾斜部材４４（図示されている実施形態において、ハブ４２の両端に、２つの傾いた傾斜部材４４が伸びている）をともなって形成されている。ユーザが装置１０にカートリッジ１２を完全に挿入していない場合であっても、ドア１４を閉じる動作（図９参照）によって、傾斜部材４４は、カートリッジ連結要素１６に対してスライドし、カートリッジ連結要素１６を押す。傾斜部材４４の傾斜した表面は、カートリッジ連結要素１６をゆっくりと押し、はめ込んで、図４よび５を参照して上述した通りに隔壁２４が中空の針２６によって突き刺されるように、装置１０内に完全に収める。
カートリッジ１２が適当な位置に固定された後、傾斜部材４４は、駆動スクリューに対する押圧を維持して、薬物ポンプの起動をもたらす。ここで、カートリッジ１２の内容物は針２６に流出し、針２６内の圧力を上昇させ、針２６から液滴が出る。この起動プロセスは、破断荷重（長期保存後にプランジャを取り外すための初期荷重）を減少させ、流路から気泡を除去する。
ドア１４の内部は、１つ以上の突出部材４６を有して形成されており、ドア１４が完全に閉じられたとき、装置１０の筺体端に形成された１つ以上の対応する溝４８（図１０）に受け入れられる。溝４８に収められている突出部材４６は、装置１０の操作の間、カートリッジ１２およびドア１４に対して作用し得る軸方向の引抜き荷重に対する抵抗力を与える。
図１０は完全に閉じられているドア１４を図示している。ドア連結要素２０は、カートリッジのカートリッジ連結要素１６および駆動手段の連結要素２２の間を連結して、駆動手段に以下の動作を実施させる。当該動作は、駆動手段による、患者に対する最終的な投与のための、上記カートリッジに収容されている物質を計量しながらのカートリッジの外部に対する当該物質の即座の排出である。
以下は図１１に対する説明である。ドア１４が完全に閉じられているとき、閉鎖部材４０のハブ４２は、すばやく締まり、閉鎖部材４０のハブ４２は、スナップ部材５０（湾曲したスナップ部材）に固定して受け入れられて、装置１０の本体に対してドア１４を適切に固定させる。
本発明が、以上において特に示されており、説明されている事項に限定されないことは、当業者に正しく理解される。より正確には、本発明の範囲は、本明細書に上述されている特徴点と、以上の記載を参照した当業者によって想到される、従来技術にはないこれらの変更および変形との組合せならびに小結合の両方を包含している。
Claims (18)
- その内部に形成されている通路（１５）を有している装置（１０）、および当該通路（１５）に挿入可能なカートリッジ（１２）を備えており、当該カートリッジ（１２）は、上記カートリッジに収納されている物質を計量して当該カートリッジから排出させることが可能な上記装置（１０）に配置されている駆動手段（１８）と接続可能なカートリッジ連結要素（１６）を含んでいる、カートリッジ挿入アセンブリであって、
上記装置（１０）に対して回転させられるドア連結要素（２０）を含んでいるドア（１４）によって特徴付けられており、上記ドア連結要素（２０）は、当該ドア（１４）が完全に閉じられたときに、当該ドア連結要素（２０）を介して上記カートリッジ連結要素（１６）と上記駆動手段（１８）の連結要素（２２）とを連結するように、上記カートリッジ連結要素（１６）と上記駆動手段（１８）の連結要素（２２）との間の位置に配置される、カートリッジ挿入アセンブリ。 - 上記装置（１０）の底面（３３）から片持ち梁として突出している固定ラッチ（３２）をさらに含んでおり、上記固定ラッチ（３２）は、上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）のリム（３４）に沿って接触しており、それによって上記通路（１５）において上記カートリッジ（１２）を固定している、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）は、上記装置（１０）に取り付けられているカートリッジストッパー（２８）に沿って接触している、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記カートリッジ（１２）は上記カートリッジ連結要素（１６）の反対側の端部に隔壁（２４）を含んでおり、上記装置（１０）は中空の針（２６）を含んでおり、上記針（２６）は、上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記隔壁（２４）に穴を開ける、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記ドア（１４）はその内部の表面上に閉鎖部材（４０）を含んでおり、上記閉鎖部材（４０）は１つ以上の傾いた傾斜部材（４４）を含んでおり、上記傾斜部材（４４）は、上記ドア（１４）の閉鎖によって上記カートリッジ連結要素（１６）をスライドさせかつ押して、上記カートリッジ（１２）を上記装置（１０）内に完全に押し込む、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記ドア（１４）は、１つ以上の突出部材（４６）を用いて形成されており、上記突出部材（４６）は、上記ドア（１４）が完全に閉じられているとき、上記装置（１０）に形成されている１つ以上の対応する溝（４８）に受け入れられている、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記ドア（１４）はその内部の表面上に閉鎖部材（４０）を含んでおり、上記閉鎖部材（４０）は、ハブ（４２）を含んでおり、上記ハブ（４２）は、上記ドア（１４）が完全に閉じられているとき、スナップ部材（５０）に固定して受け入れられている、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記連結要素（１６、２０）は歯車を含んでいる、請求項１に記載のカートリッジ挿入アセンブリ。
- 上記装置（１０）の底面（３３）から片持ち梁として突出している固定ラッチ（３２）をさらに含んでおり、当該固定ラッチ（３２）は、上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）のリム（３４）に沿って接触することによって、上記通路（１５）に上記カートリッジ（１２）を固定し、
上記ドア（１４）は、その内側の表面上の閉鎖部材（４０）を含んでおり、当該閉鎖部材（４０）は、１つ以上の傾いた傾斜部材（４４）を含んでおり、上記傾斜部材（４４）は、上記ドア（１４）の閉鎖によって上記カートリッジ連結要素（１６）をスライドさせかつ押して、上記装置（１０）に上記カートリッジ（１２）を完全に押し込み、
上記ドア（１４）がその内側表面の閉鎖部材（４０）を含んでおり、上記閉鎖部材（４０）は、ハブ（４２）を含んでおり、上記ハブ（４２）は、上記ドア（１４）が完全に閉じられているとき、スナップ部材（５０）に固定して受け入れられている、請求項１に記載のカートリッジ挿入アセンブリ。 - カートリッジ挿入アセンブリであって、
その内部に形成されている通路（１５）を有している装置（１０）；当該通路（１５）に挿入可能なカートリッジ（１２）；および上記装置（１０）に対して回転させられる、ドア連結要素（２０）を含んでいるドア（１４）を備えており、
上記カートリッジ（１２）は、上記カートリッジに収納されている物質を計量して当該カートリッジから排出させることが可能な上記装置（１０）に配置されている駆動手段（１８）と接続可能なカートリッジ連結要素（１６）を含んでおり、
上記ドア連結要素（２０）は、回転動作を伝達するための大きさおよび形状に形成されており、上記ドア連結要素（２０）は、当該ドア（１４）が完全に閉じられたときに、当該ドア連結要素（２０）を介して上記カートリッジ連結要素（１６）と上記駆動手段（１８）の連結要素（２２）とを連結するように、上記カートリッジ連結要素（１６）と上記駆動手段（１８）の連結要素（２２）との間の位置に配置される、カートリッジ挿入アセンブリ。 - 上記装置（１０）の底面（３３）から片持ち梁として突出している固定ラッチ（３２）をさらに含んでおり、上記固定ラッチ（３２）は、上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）のリム（３４）に沿って接触しており、それによって上記通路（１５）において上記カートリッジ（１２）を固定している、請求項１０に記載のカートリッジ挿入アセンブリ。
- 上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）は、上記装置（１０）に取り付けられているカートリッジストッパー（２８）に沿って接触している、請求項１０に記載のカートリッジ挿入アセンブリ。
- 上記カートリッジ（１２）は上記カートリッジ連結要素（１６）の反対側の端部に隔壁（２４）を含んでおり、上記装置（１０）は中空の針（２６）を含んでおり、上記針（２６）は、上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記隔壁（２４）に穴を開ける、請求項１０に記載のカートリッジ挿入アセンブリ。
- 上記ドア（１４）はその内部の表面上に閉鎖部材（４０）を含んでおり、上記閉鎖部材（４０）は１つ以上の傾いた傾斜部材（４４）を含んでおり、上記傾斜部材（４４）は、上記ドア（１４）の閉鎖によって上記カートリッジ連結要素（１６）をスライドさせかつ押して、上記カートリッジ（１２）を上記装置（１０）内に完全に押し込む、請求項１０に記載のカートリッジ挿入アセンブリ。
- 上記ドア（１４）は、１つ以上の突出部材（４６）を用いて形成されており、上記突出部材（４６）は、上記ドア（１４）が完全に閉じられているとき、上記装置（１０）に形成されている１つ以上の対応する溝（４８）に受け入れられている、請求項１０に記載のカートリッジ挿入アセンブリ。
- 上記ドア（１４）はその内部の表面上に閉鎖部材（４０）を含んでおり、上記閉鎖部材（４０）は、ハブ（４２）を含んでおり、上記ハブ（４２）は、上記ドア（１４）が完全に閉じられているとき、スナップ部材（５０）に固定して受け入れられている、請求項１０に記載のカートリッジ挿入アセンブリ。
- 上記連結要素（１６、２０）は歯車を含んでいる、請求項１０に記載のカートリッジ挿入アセンブリ。
- カートリッジ挿入アセンブリであって、
その内部に形成されている通路（１５）を有している装置（１０）；当該通路（１５）に挿入可能なカートリッジ（１２）；上記装置（１０）に対して回転させられるドア連結要素（２０）を含んでいるドア（１４）；および上記装置（１０）の底面（３３）から片持ち梁として突出している固定ラッチ（３２）を備えており、
上記カートリッジ（１２）は、上記カートリッジに収納されている物質を計量して当該カートリッジから排出させることが可能な上記装置（１０）に配置されている駆動手段（１８）と接続可能なカートリッジ連結要素（１６）を含んでおり、
上記ドア連結要素（２０）は、当該ドア（１４）が完全に閉じられたときに、当該ドア連結要素（２０）を介して上記カートリッジ連結要素（１６）と上記駆動手段（１８）の連結要素（２２）とを連結するように、上記カートリッジ連結要素（１６）と上記駆動手段（１８）の連結要素（２２）との間の位置に配置され、
上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）は、上記装置（１０）に取り付けられているカートリッジストッパー（２８）に沿って接触して
上記固定ラッチ（３２）は、上記カートリッジ（１２）が上記装置（１０）に完全に挿入されているとき、上記カートリッジ（１２）のリム（３４）に沿って接触しており、それによって上記通路（１５）において上記カートリッジ（１２）を固定している、カートリッジ挿入アセンブリ。
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| US12/559,563 US8157769B2 (en) | 2009-09-15 | 2009-09-15 | Cartridge insertion assembly for drug delivery system |
| US12/559,563 | 2009-09-15 | ||
| PCT/US2010/048556 WO2011034799A1 (en) | 2009-09-15 | 2010-09-12 | Cartridge insertion assembly for drug delivery system |
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| BR112012005660A2 (pt) | 2018-03-20 |
| US8157769B2 (en) | 2012-04-17 |
| US8465455B2 (en) | 2013-06-18 |
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| EP2477679B1 (en) | 2014-08-13 |
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| US20120035546A1 (en) | 2012-02-09 |
| US20130296792A1 (en) | 2013-11-07 |
| US20110066131A1 (en) | 2011-03-17 |
| USD882761S1 (en) | 2020-04-28 |
| US10688243B2 (en) | 2020-06-23 |
| BR112012005660B1 (pt) | 2020-05-26 |
| WO2011034799A1 (en) | 2011-03-24 |
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