JP2018531133A - 充填済流体容器の屈曲流体路型付属物 - Google Patents
充填済流体容器の屈曲流体路型付属物 Download PDFInfo
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- JP2018531133A JP2018531133A JP2018538073A JP2018538073A JP2018531133A JP 2018531133 A JP2018531133 A JP 2018531133A JP 2018538073 A JP2018538073 A JP 2018538073A JP 2018538073 A JP2018538073 A JP 2018538073A JP 2018531133 A JP2018531133 A JP 2018531133A
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Abstract
Description
図1は、パッチ型自己注射器の簡易側面図である。
図2Aおよび図2Bは、任意の例示的実施形態に係るモジュール式のパッチ型自己注射器の簡易側面図である。
図3A〜図3Pは、例示的実施形態に係る、注射器と流体容器との結合部材の簡易断面図および簡易斜視図である。
図4A〜図4Hは、例示的実施形態に係るモジュール式の流体容器・注射器結合システムの簡易上面図および簡易斜視図である。
図5A、図5B、図5C、図5D、図5E、図5Fおよび図5Gは、流体容器を自己注射器に結合させる締結部材の配置位置を示す簡易部分断面側面図である。
図6は、自己注射のための家庭用キットの簡易上面図である。
図1は、パッチ型の自己注射器の簡易側面図である。このパッチ型自己注射器は、米国特許仮出願第62/284,806号に記載されており、その記載内容を全体として本明細書に援用する。自己注射器100は、カートリッジ104に結合された屈曲針102を備えている。屈曲針102は、例えば、90度の角度で屈曲している。カートリッジ104には、注射物質が予め充填されていてもよい。カートリッジ104は、支持プレート106に搭載されていてもよく、プランジャ108を含んでいてもよい。プランジャ108は、電動モータの駆動ギア110によって駆動されるものである。カートリッジ104は、注入処置を経た後に廃棄されると共に、新たな充填済カートリッジと交換されてもよい。
図2A、図2B、および図2C(図2と総称する)は、任意の例示的実施形態に係るモジュール式のパッチ型自己注射器の簡易側面図である。図2に示したように、自己注射器200は、種々の異なる種類および大きさを有する流体容器を収容することが可能な大きさを有していてもよい。図1に示した例のように、自動注射器200は、いくつかの実施形態では、屈曲針202を備えている。屈曲針202は、例えば、90度の角度で屈曲している。本開示の他の部分においてより詳細に説明されているように、自己注射器200は、いくつかの実施形態では、支持プレート204と共に、少なくとも屈曲針202の針保持部206を備えている。針保持部206は、いくつかの実施形態では、流体容器250または流体容器255の先端部252を収容することが可能な大きさを有する穴208を少なくとも有している。穴208は、いくつかの実施形態では、針202の屈曲部212に至る開口部210を含んでいる。針202の少なくとも一部は、いくつかの実施形態では、封止状態を維持しながら開口部210を経由して穴208の内部まで延在している。針保持部206は、いくつかの実施形態では、支持プレート204上に固定されている。
一般的に用いられる流体容器の先端部としては、嵌め込み(slip-on)型または押し込み(push-on)型の先端部と、ルアーロック(Luer lock)型の先端部とが挙げられる。プラスチック製の流体容器は、双方の種類のプラスチック製先端部を備えている一方、ガラス製の流体容器の先端部は、一般的には金属によって構成されている。一部のガラス製流体容器は、ガラス製の嵌め込み型の先端部を備えている。一般的に用いられる流体容器と針との結合手法においては、注射物質の通路の滅菌化が図られるが、これは場合によっては困難を伴い得る。典型的な手法としては、流体容器および針のそれぞれを滅菌された袋(pouch)中に保存することによって、袋からの取り出し時から注射時までにそれらが周囲の環境に曝される時間を限定する手法が挙げられる。この手法は、自己注射器の場合、とりわけパッチ型の自己注射器の場合には、実用的でない。
図3A〜図3P(図3と総称する)は、例示的実施形態に係る注射器と流体容器との結合部材の簡易断面図および簡易斜視図である。図3A〜図3Lに示した例示的実施形態は、流体容器のうちの1以上の異なる種類の先端部に屈曲針202を結合させる1以上のアダプタを示している。例えば、図3Aは、アダプタ302を備えた針保持部206を示している。アダプタ302は、流体容器のうちの嵌め込み型または押し込み型の先端部352に屈曲針202を結合させる大きさを有している。中心に設けられた穴308は、一方の側では開口部306において開口しており、その反対側では開口部310において終端している。開口部306は、流体容器の先端部を受容するために、流体容器に対向している。開口部310は、封止状態を維持しながら屈曲針202の少なくとも一部を収容することが可能な大きさを有している。穴308は、例えば、いくつかの実施形態では、円錐形状を有している。または、穴308は、例えば、いくつかの実施形態では、円筒形状を有している。また、図3Cに示したように、針保持部206は、例えば、いくつかの実施形態では、さらに、弾性を有する取り付け部材312を備えていてもよい。取り付け部材312は、接着またはその他の適切な手法によって、開口部306の上に取り付けられている。取り付け部材312は、いくつかの実施形態では、開口部314を有していてもよい。開口部314は、流体容器のうちのスライド型(摺動装着(slide-on)型)であると共に対応する大きさを有する先端部を収容することが可能な大きさを有している。弾性取り付け部材312は、いくつかの実施形態では、注射器200における所定位置に係止されることによって、流体容器350の少なくとも一部が弾性取り付け部材312に対して付勢された際に、流体容器の先端部と針との結合部分からの漏出の可能性を低下させるものである。
図3G〜図3Iに示した自己注射器200は、屈曲針202と、ルアーロック型の結合部材316とを備えている。ルアーロック型結合部材316は、ルアーロック型のオス型先端部362を有する流体容器350を受容することが可能な大きさを有している。ルアーロック型結合部材316は、いくつかの実施形態では、シリンダを備えている。シリンダの一端部は、屈曲針202および自己注射器200に封止状態を維持しながら結合されている。また、シリンダの反対側の端部は、ツメ付き縁部(tabbed rim)322を備えている。シリンダの反対側の端部は、開口部306の穴308に向かって開口している。ツメ付き縁部322は、いくつかの実施形態では、流体容器のうちのルアーロック型のオス型先端部362に設けられたスリーブ364に螺合するように構成されている。図3Iは、ルアーロック型結合部材316と流体容器350のうちのルアーロック型の先端部362とが完全に一体化された構成を示している。
本発明のいくつかの実施形態の一側面は、モジュール式の流体容器・注射器結合システムを備えた自己注射器に関する。自己注射器、具体的にはパッチ型自己注射器は、注射処理の際における組織内の注射針の移動を防ぐことにより、注射に伴う痛みを最小限に抑えるように設計されている。これは、自己注射器のハウジングに注射針および/または流体容器のカートリッジを固定されるように取り付ける各種結合方法によって達成される。
流体容器と自己注射器との固定結合を確保するためには、流体容器を支持プレート410等の表面に固定する以外にも、締結部材420、締結部材414および締結部材424等の締結部材を流体容器のバレル部の長さとなるように調整する必要がある。これは、多くの場合、本開示の他の部分に記載されているように、流体容器のバレル部に沿うように締結部材を摺動させることにより、および/または流体容器のフィンガフランジに締結部材を結合させることによって、達成される。本開示の他の部分に記載されているモジュール式の支持プレート410の構造では、例えば、流体容器のバレル部またはフィンガフランジに対する取り付けの際、締結部材をほとんどの所望位置に配置することが可能である。図5A〜図5Gは、流体容器を自己注射器に結合させる締結部材の配置位置を示す簡易部分断面側面図である。
Claims (56)
- 自己注射器用の付属物であって、
少なくとも1つの結合部材を有するアダプタと、
第1端部が組織を貫通するように構成されると共に第2端部が前記アダプタに結合された屈曲流体路と、
を備え、
前記少なくとも1つの結合部材は、前記アダプタを流体容器に結合させる大きさおよび形状を有し、
前記流体容器に結合された前記付属物は、滅菌されると共に注射物質が充填されるように構成された一体型の自己注射器のカートリッジユニットを形成している
自己注射器用の付属物。 - さらに、
針保護キャップを備えた
請求項1のいずれか1項に記載の付属物。 - 前記流体路は、90度の角度で屈曲している
請求項1または請求項2のいずれか1項に記載の付属物。 - さらに、
前記容器の前記本体を自己注射器に結合させる大きさを有する少なくとも1つの締結部材を備えた
請求項1または請求項2のいずれか1項に記載の付属物。 - 自己注射器用の付属物であって、
少なくとも1つの結合部材を有するアダプタと、
第1端部が組織を貫通するように構成されると共に第2端部が前記アダプタに結合された屈曲流体路と、
を備え、
前記少なくとも1つの結合部材は、前記アダプタを流体容器に結合させる大きさおよび形状を有し、
前記付属物が前記流体容器に結合された際、前記容器と前記屈曲流体路の前記第1端部との間に滅菌された流体連結が確保されている
自己注射器用の付属物。 - 前記屈曲流体路は、前記第2端部に結合部材を有し、
前記屈曲流体路の前記結合部材は、前記屈曲流体路を前記アダプタに結合させる大きさおよび形状を有すると共に、それらの間に滅菌された流体連結を確保している
請求項5に記載の付属物。 - さらに、
前記容器の前記本体を自己注射器に結合させる大きさを有する少なくとも1つの締結部材を備えた
請求項5に記載の付属物。 - 前記屈曲流体路は、中空針を含む
請求項5に記載の付属物。 - 前記流体路は、90度の角度で屈曲している
請求項5に記載の付属物。 - 前記容器は、充填済カートリッジである
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記容器は、シリンジである
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記容器は、バイアルである
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記容器の少なくとも一部は、ガラスによって形成されている
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記容器の少なくとも一部は、プラスチック材料によって形成されている
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記付属物は、全体に渡って滅菌可能である
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記アダプタ結合部材は、ルアーロック型の結合部材である
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記アダプタ結合部材は、バイアルアダプタである
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記アダプタ結合部材は、スライド型の流体容器結合部材である
請求項5から請求項9のいずれか1項に記載の付属物。 - 前記アダプタは、さらに、自己注射器に前記付属物を結合させる大きさおよび形状を有する結合部材を含む
請求項5から請求項9のいずれか1項に記載の付属物。 - 自己注射器用の付属物であって、
少なくとも1つの屈曲流体路を有すると共に、流体容器の少なくとも先端部に滅菌された前記屈曲流体路を結合させる大きさを有する少なくとも1つのアダプタと、
前記流体容器の本体および前記自己注射器に対する大きさを有する少なくとも1つの締結部材と、
を備え、
前記アダプタおよび前記締結部材は、異なる大きさおよび異なる先端部の種類を有する複数の容器のうちの少なくとも1つを前記自己注射器に結合させるように構成されている
自己注射器用の付属物。 - 前記アダプタと前記締結部材との間の間隔は、調整可能である
請求項20に記載の付属物。 - 前記締結部材の内径は、調整可能である
請求項20および請求項21のいずれか1項に記載の付属物。 - 前記付属物は、さらに、前記締結部材の内径に沿うように取り付けられる大きさおよび形状を有する取り付け部材を備えた
請求項20から請求項21のいずれか1項に記載の付属物。 - 前記取り付け部材は、前記締結部材の内径を減少させている
請求項19に記載の付属物。 - 前記締結部材の少なくとも一部は、プラスチック材料によって形成されている
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記流体容器の少なくとも一部は、ガラスによって形成されている
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記流体容器の少なくとも一部は、プラスチック材料によって形成されている
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記屈曲流体路は、中空針を含む
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記流体路は、90度の角度で屈曲している
請求項24に記載の付属物。 - 前記容器は、充填済カートリッジである
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記容器は、流体容器である
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記容器は、バイアルである
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記付属物は、全体に渡って滅菌可能である
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記アダプタ結合部材は、ルアーロック型の結合部材である
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記アダプタ結合部材は、バイアルアダプタである
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記アダプタ結合部材は、スライド型の流体容器結合部材である
請求項20から請求項22のいずれか1項に記載の付属物。 - 前記アダプタは、さらに、前記付属物を自己注射器に結合させる大きさおよび形状を有する結合部材を含む
請求項20から請求項22のいずれか1項に記載の付属物。 - 複数の取り付けポイントを有する支持プレートを含む自己注射器と、
少なくとも1つの屈曲流体路を有すると共に、流体容器の少なくとも先端部に滅菌された前記屈曲流体路を結合させる大きさを有する少なくとも1つのアダプタと、
前記流体容器の本体および前記取り付けポイントのうちの少なくとも1つに結合される大きさを有する少なくとも1つの締結部材と、
を備えた自己注射器結合システムの付属物。 - 前記アダプタは、前記取り付けポイントのうちの少なくとも1つに結合される大きさを有している
請求項38に記載のシステム。 - 前記取り付けポイントは、前記支持プレートの上において、前記アダプタから種々の異なる距離だけ離れた位置に分散配置されている
請求項38および請求項39のいずれか1項に記載のシステム。 - 前記種々の異なる距離は、前記流体容器の種々の異なる長さに対応する
請求項38に記載のシステム。 - 前記締結部材の内径は、調整可能である
請求項38から請求項39のいずれか1項に記載のシステム。 - 前記システムは、さらに、前記締結部材の内径に沿うように取り付けられる大きさおよび形状を有する取り付け部材を備えた
請求項38から請求項39のいずれか1項に記載のシステム。 - 前記取り付け部材は、前記締結部材の前記内径を減少させている
請求項43に記載のシステム。 - 複数の取り付けポイントを有する支持プレートを含む少なくとも1つの自己注射器と、
少なくとも1つの屈曲流体路を有すると共に、少なくとも1つの種類の流体容器の少なくとも先端部に滅菌された前記屈曲流体路を結合させる大きさを有する複数のアダプタと、
前記流体容器の本体の少なくとも1つの直径および前記取り付けポイントのうちの少なくとも1つに結合される大きさを有する複数の締結部材と、
を備えた自己注射器キット。 - さらに、
前記複数の締結部材のうちの少なくとも1つの締結部材の内径に沿うように取り付けられる大きさおよび形状を有する少なくとも1つの取り付け部材を備えた
請求項45に記載のキット。 - 前記取り付け部材は、前記締結部材の内径を減少させている
請求項42に記載のキット。 - 前記流体容器は、充填済カートリッジ、シリンジおよびバイアルのうちの少なくとも1つである
請求項45から請求項47のいずれか1項に記載のキット。 - 前記流体容器の少なくとも一部は、ガラスによって形成されている
請求項45から請求項47のいずれか1項に記載のキット。 - 前記締結部材の少なくとも一部は、プラスチック材料によって形成されている
請求項45から請求項47のいずれか1項に記載のキット。 - 前記アダプタのうちの少なくとも1つは、滅菌されている
請求項45から請求項47のいずれか1項に記載のキット。 - 空の流体容器を選択する工程と、
少なくとも1つの屈曲流体路を有すると共に、前記流体容器の少なくとも先端部に前記屈曲流体路を流体結合させる大きさを有するアダプタに、前記流体容器の少なくとも先端部を結合させることにより、自己注射器のカートリッジユニットを形成する工程と、
前記流体容器と前記屈曲流体路との間に流体連結を形成する工程と、
を含む自己注射器用の付属物の組立方法。 - さらに、
前記カートリッジを滅菌する工程と、
滅菌された注射物質を前記流体容器に充填する工程と、
前記流体容器の流体路のうちの非屈曲端部にプランジャを挿入する工程と、
前記流体容器の前記端部を滅菌しながら封止する工程と、
を含む請求項52に記載の方法。 - さらに、
少なくとも1つの締結部材を選択すると共に、前記流体容器の本体に前記締結部材を結合させる工程と、
前記注射器のうちの少なくとも1つの対応する取り付けポイントに前記締結部材を結合させる工程と、
を含む請求項52に記載の方法。 - 流体容器を選択する工程と、
少なくとも1つの屈曲流体路を有すると共に、前記流体容器の少なくとも先端部に前記屈曲流体路を流体連結させる大きさを有するアダプタに、前記流体容器の少なくとも先端部を結合させる工程と、
前記流体容器と前記屈曲流体路との間に滅菌された連結を形成する工程と、
を含む自己注射器用の付属物を流体容器に結合させる方法。 - さらに、
少なくとも1つの締結部材を選択すると共に、前記流体容器の本体に前記締結部材を結合させる工程と、
前記注射器のうちの少なくとも1つの対応する取り付けポイントに前記締結部材を結合させる工程と、
を含む請求項55に記載の方法。
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US15/269,248 US10086145B2 (en) | 2015-09-22 | 2016-09-19 | Rotation resistant friction adapter for plunger driver of drug delivery device |
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