JP6710185B2 - 治療薬の制御送達のための装着型自動注入装置 - Google Patents
治療薬の制御送達のための装着型自動注入装置 Download PDFInfo
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
例示的実施形態の理解を容易にするために、ここで特定の用語が定義される。
図1から図10を参照して、特定の例示的な装着型自動注入装置が記載される。治療薬を運搬するために例示的な装着型自動注入装置で使用されてもよい特定の例示的な針システムは、図11から図23を参照して記載される。シリンジまたはカートリッジから治療薬を放出するために例示的な装着型自動注入装置で使用されてもよい特定の例示的なプランジャ作動システムは、図24から図51を参照して記載される。注射針を注入後状態の後退位置に保持するために例示的な装着型自動注入装置で使用されてもよい特定の例示的な針保護システムは、図52から図55を参照して記載される。
例示的実施形態は、1回分の治療薬を患者の皮膚に注入するための、異なる例示的な針アセンブリを提供する。いくつかの例示的実施形態において、患者の皮膚に投与量を注入するために、投与量を収容する例示的な自動注入装置のバレル部に結合された注射針が患者の皮膚に挿入されてもよい。その他の例示的実施形態において、バレル部から投与量を導出するために、投与量を収容するバレル部にシリンジ針が結合されてもよく、患者の皮膚に投与量を注入するために、シリンジ針に結合された注射針が患者の皮膚に挿入されてもよい。
例示的実施形態は、栓がバレル部内を前方に移動して、バレル部に収容されている投与量の治療薬を放出するように、装着型自動注入装置のバレル部内の栓を作動させる、プランジャ作動システムを提供する。プランジャ作動システムを起動するために、いずれの適切なトリガ機構が使用されてもよい。一例示的実施形態において、トリガ機構は、装着型自動注入装置が注入前状態から注入状態に移動するときに、プランジャ作動システムを自動的に起動してもよい。一例示的実施形態において、シリンジまたはカートリッジアセンブリと注射針との間に流体路を提供するための筐体内での注入ボタンの下方垂直運動は、プランジャ作動システムを起動するための起動力を提供するだろう。別の例示的実施形態において、シリンジまたはカートリッジアセンブリと注射針との間に流体路を確立するための筐体内でのシリンジまたはカートリッジアセンブリの前進運動は、プランジャ作動システムを起動するための起動力を提供するだろう。別の例示的実施形態において、プランジャ作動システムは、ユーザによって手動で起動されてもよい。
例示的実施形態は、注入後の注入後状態で装着型自動注入装置内に注射針を保持するための異なる例示的な針保護システムを提供する。針の保護は、偶発的な針刺しによって患者または装着型自動注入装置の近傍にいるその他いずれかの人物が負傷するのを防止する。
例示的な自動注入装置は、本質的に注入による投与に適したいずれかの物質または治療薬を投与するために使用されてもよい。通常、物質または治療薬は、流体、たとえば液体の形態となるが、ただし装着型自動注入装置がそのような形態の薬剤の投与を許容するように設計されていれば、ゲルまたは半固体、スラリ、微粒子溶液など、その他の形態の薬剤もまた使用に適しているだろう。
本発明の一実施形態によれば、図示される自動注入装置は、関節炎およびその他の病気を治療するために使用される1回分のTNF阻害剤を送達するために使用されてもよい。一実施形態において、シリンジに収容された溶液は、pHを約5.2に調整するために必要に応じてUSP水酸化ナトリウムが添加された、注入のための、たとえば40または80mgのアダリムマブ、4.93mgの塩化ナトリウム、0.69mgの無水リン酸一ナトリウム、1.22mgの無水リン酸二ナトリウム、0.24mgのクエン酸ナトリウム、1.04mgのクエン酸一水和物、9.6mgのマンニトール、0.8mgのポリソルベート50、および水など、40または80ミリグラムの製剤(TNFα遮断剤または阻害剤)/1mLを含有する。
医薬組成物は、患者への送達のために本発明の自動注入装置に装填されてもよい。一実施形態において、抗体、抗体部分、ならびにその他のTNFα阻害剤は、本発明の装置を用いる患者への投与に適した医薬組成物に組み込まれることが可能である。通常、医薬組成物は、抗体、抗体部分、またはその他のTNFα阻害剤、および製薬上許容可能な担体を含む。「製薬上許容可能な担体」は、生理学的に適合する、ありとあらゆる溶媒、分散媒、被膜、抗菌および抗真菌剤、等張および吸収遅延剤などを含む。製薬上許容可能な担体の例は、水、生理食塩水、リン酸緩衝生理食塩水、デキストロース、グリセロール、エタノールなどのうちの1つ以上、ならびにこれらの組み合わせを含む。多くの場合、組成物中に、糖類、マンニトールのような多価アルコール、ソルビトール、または塩化ナトリウムなどの等張剤を含むことが、好ましい。製薬上許容可能な担体は、湿潤または乳化剤、防腐剤、または緩衝剤など、少量の補助物質をさらに含んでもよく、これらは抗体、抗体部分、またはその他のTNFα阻害剤の保管寿命または有効性を強化する。
本明細書全体を通じて引用された、特許および特許出願を含む、すべての参考文献の内容は、参照によりその全体が本願に組み込まれる。これら参考文献の適切な構成要素および方法は、本発明およびその実施形態のために選択されてもよい。さらにまた、背景技術の章で特定された構成要素および方法は、本開示に不可欠であり、本発明の範囲内で本開示のいずれかの箇所に記載された構成要素および方法と組み合わせて使用されるか、またはこれに代えて使用されることが、可能である。
例示的実施形態の記載において、明確さのために特定の専門用語が使用されている。説明目的のため、各々の特定用語は、類似の目的を達成するために類似の方式で動作するすべての技術的および機能的同等物を、少なくとも含むように意図されている。加えて、特定の例示的実施形態が複数のシステム要素または方法ステップを含むいくつかの例において、これらの要素またはステップは、単一の要素またはステップに置き換えられてもよい。同様に、単一の要素またはステップは、同じ目的に役立つ複数の要素またはステップに置き換えられてもよい。さらに、様々な特性のパラメータが例示的実施形態のために本明細書において指定されている場合、これらのパラメータは、別途指定のない限り、1/20、1/10、1/5、1/3、1/2などだけ、またはその四捨五入された近似値に、切り上げまたは切り捨てられてもよい。また、例示的実施形態はその特定の実施形態を参照して提示および記載されてきたが、当業者は、本発明の範囲を逸脱することなく、その形態および詳細において様々な代替例および変形例がなされてもよいことを、理解するだろう。さらにまた、その他の態様、機能、および利点もまた本発明の範囲に含まれる。
Claims (31)
- 患者に治療薬を注射するための装着型自動注入装置であって、前記装着型自動注入装置が、
患者に対して固定可能な患者接触部を有する筐体と、
治療薬を保持するための筐体内の容器と、
容器内に設けられた栓と、
容器と流体連絡可能なシリンジ針と、
シリンジ針と流体連絡可能である患者への挿入のための注射針を有し、筐体内に移動可能に設けられた注入アセンブリと、
流体ベースの作動機構とを含み、前記流体ベースの作動機構は、保持された非圧縮性作動流体に流体圧力を提供する圧力要素を有し、かつ1つ以上の流体回路を有し、前記1つ以上の流体回路は、容器から治療薬を送出するように栓に力を供給するために栓と流体連通する圧力要素から非圧縮性作動流体を運搬し、
前記装着型自動注入装置はさらに、流体ベースの作動機構に結合された送達トリガを含み、作動機構は、始動すると、圧力要素に、栓と流体連絡するように作動流体を解放させる、装着型自動注入装置。 - 流体ベースの作動機構は、圧力要素と栓との間に設けられた流体導管をさらに含む、請求項1に記載の装着型自動注入装置。
- 流体ベースの作動機構は、容器からの治療薬の送出を調整するために栓と圧力要素との間に結合された減衰機構をさらに含む、請求項2に記載の装着型自動注入装置。
- 減衰機構が、容器に向かう流量制限器の下流の液圧を作動流体源に向かう流量制限器の上流の液圧よりも低い圧力に維持するための流量制限器を含む、請求項3に記載の装着型自動注入装置。
- 圧力要素は、配管を使用して流量制限器に結合される、請求項4に記載の装着型自動注入装置。
- 非圧縮性作動流体は、水または油の一方を含む、請求項1に記載の装着型自動注入装置。
- 圧力要素は、弾性気槽、マスタシリンダ、またはバネ式シリンジの1つを含む、請求項1に記載の装着型自動注入装置。
- 容器が、筐体内に移動可能に設けられている、請求項1に記載の装着型自動注入装置。
- 穿通可能な隔膜をさらに含み、前記穿通可能な隔膜が、注入前状態においてシリンジ針を注入アセンブリの滅菌流体導管から分離する、請求項1に記載の装着型自動注入装置。
- 容器が、注入状態において移動して、シリンジ針を穿通可能な隔膜に穿通させ、シリンジ針と注射針との間に流体連絡を確立する、請求項9に記載の装着型自動注入装置。
- 容器を注入前状態における第一位置から注入状態における第二位置まで自動的に作動させるためのカートリッジアクチュエータをさらに含む、請求項10に記載の装着型自動注入装置。
- 流体ベースの作動機構および患者接触部が、非滅菌状態である、請求項1に記載の装着型自動注入装置。
- 筐体が、非滅菌状態である、請求項1に記載の装着型自動注入装置。
- 筐体の外側から容器によって保持されている治療薬をユーザが検査できるようにする、筐体に設けられた検査窓をさらに含む、請求項1に記載の装着型自動注入装置。
- 流体ベースの作動機構が、患者への治療薬の送達速度を調整する流量制限器を含む、請求項1に記載の装着型自動注入装置。
- 注射針を注入後状態の筐体内の後退位置に自動的に係止するための針係止機構をさらに含む、請求項1に記載の装着型自動注入装置。
- 針係止機構が、
筐体の注射針開口の上に移動可能に設けられた障壁機構を含み、
注射針開口は、障壁機構が第一位置にあるときに開放して注射針を筐体の外側に突起させ、
注射針開口は、障壁機構が第二位置にあるときに閉鎖して注射針が筐体の外側に突起するのを防止する、請求項16に記載の装着型自動注入装置。 - 針係止機構が、
注入状態の伸長位置から注入後状態の後退位置への注入アセンブリの後退に反応する針ロック解放機構と、
注射針および針ロック解放機構に結合された旋回部材とを含み、
針ロック解放機構の始動が旋回部材に注射針を筐体の注射針開口から離れる方に旋回させる、請求項16に記載の装着型自動注入装置。 - シリンジ針と注射針との間に滅菌流体導管を画定する搬送機構をさらに含む、請求項1に記載の装着型自動注入装置。
- 搬送機構に結合された注入ボタンをさらに含む、請求項19に記載の装着型自動注入装置。
- 搬送機構が、アダプタを含み、前記アダプタが、シリンジ針および注射針に結合され、シリンジ針と注射針との間に滅菌流体導管を確立する、請求項19に記載の装着型自動注入装置。
- アダプタの第一部分が、長手軸と実質的に平行に容器から延在する、請求項21に記載の装着型自動注入装置。
- アダプタの第二部分が、長手軸に対して実質的に直角にアダプタの第一部分から延在する、請求項22に記載の装着型自動注入装置。
- アダプタの第二部分が、注射針に結合可能である、請求項23に記載の装着型自動注入装置。
- アダプタの第一部分およびアダプタの第二部分が、一体に形成されている、請求項23に記載の装着型自動注入装置。
- アダプタの第一部分が、容器の遠位末端を実質的に包む、請求項21に記載の装着型自動注入装置。
- アダプタが、注射針を長手軸に対して約90度で延在できるようにする、請求項21に記載の装着型自動注入装置。
- 滅菌流体導管が、搬送機構において中央に延在するチャネルであり、前記チャネルを通って、治療薬がシリンジ針から注射針まで流れる、請求項27に記載の装着型自動注入装置。
- 滅菌流体導管が、上昇壁部を含み、上昇壁部は、チャネルへ治療薬を強制するために中央に延在するチャネルの縁に沿って延在する、請求項28に記載の装着型自動注入装置。
- 装着型自動注入装置が、電力によらず動作可能である、請求項1に記載の装着型自動注入装置。
- 治療薬が、一定の線形流量の線形送達プロファイルで送達される、請求項1に記載の装着型自動注入装置。
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