JP2022044640A - 積層型止具を含む医療用送達装置 - Google Patents
積層型止具を含む医療用送達装置 Download PDFInfo
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Abstract
Description
当業者には自明だが、本開示の様々な側面は、意図された機能を行うように構成されている任意の数の方法及び装置により実現されてもよい。また、添付の図面の図は、必ずしも縮尺通りに描画されておらず、本開示の様々な側面を例示するために誇張されている場合がある。この点で、図面の図を限定的と解釈すべきではない。
図1は、少なくとも一態様による注射器10(前充填された注射器であってもよい)を示す。当業者には自明であるように、本発明は以後、注射器に関するものとして記載されるが、本開示の精神及び範囲を逸脱することなく他の種類の医療用送達装置、例えば、自動注射器又はカートリッジなどが想起される。注射器10は、対向する遠位端20と近位端25を有する外筒15、及び遠位端20と近位端25の間に配置された受容室30を含む。外筒15は実質的に剛直なすなわち硬い材料で形成されていてもよい。そのような材料としては、例えば、ガラス材料(例えば、ホウケイ酸ガラス)、セラミック材料、1種以上の重合性材料(例えば、ポリプロピレン、ポリエチレン、及びこれらの共重合体)、金属材料、又はプラスチック材料(例えば、環状オレフィン重合体(COC)及び環状オレフィン共重合体(COP)、及びこれらの組み合わせが挙げられる。
態様によっては、1つ以上の積層体層130は、フッ素重合体の単層を含んでいてもよい。図2は、弾性体125及びフッ素重合体の単層すなわち障壁層140を含む止具100を示す。弾性体125を形成するのに用いることができるエラストマーの例としては、本願に好適な任意のエラストマー、特に、ブチル、ブロモブチル、クロロブチル、シリコーン、ニトリル、スチレンブタジエン、ポリクロロプレン、エチレンプロピレンジエン、フッ素エラストマー、熱可塑性エラストマー(TPE)、熱可塑性加硫物(TPV)、商品名VITON(登録商標)で販売されている材料、並びにこれらの組み合わせ及び混合物から構築されたゴムが挙げられる。エラストマー性材料の例としては、これらに限定されないが、ブチルゴム、ブロモブチルゴム、クロロブチルゴム、シリコーン、ニトリル、スチレンブタジエン、ポリクロロプレン、エチレンプロピレンジエン、フッ素エラストマー、及びこれらの組み合わせが挙げられる。
態様によっては、止具100は、容認できる程度に小さい始動力と摺動力を維持しつつ、空気と液体に対する高い不透過性を有する容器の閉鎖完全性を達成するように構成されている。図10A及び図10Bは、対向する近位端210及び遠位端215、及び2つ以上のリブ220を含む本体205を含む止具100を示す。頭部225は、本体205の遠位端215と一体に形成されている。本体205の外表面には1つ以上の環状溝230が形成されており、これにより、2つ以上のリブ220を形成して結合している。2つ以上のリブ220のうちの少なくとも1つには1つ以上の積層体層130が積層されている。空洞240は、本体205の210から遠位端215に向かって延びていてもよい。プランジャー棒85の遠位端90は、止具の空洞240に挿入されて固定されていてもよい。
自明の通り、特定の方法及び実験を以下で記載するが、当業者が好適であると判定した他の方法あるいは装置を代わりに用いてもよい 。
プランジャーの外筒に対する封止を評価するため、組み立てた注射器系の内部から外環境へのヘリウム漏出率を評価した。これは、乾燥したむき出しのガラスの外筒(潤滑剤を含まない)に止具を入れて、プランジャー棒を拘束し、試験中に止具が動かないようにして行った。組み立てた注射器の内容積を真空装置を用いて針を介して真空排気し、約1psigに加圧したヘリウム雰囲気に置換した。ヘリウムに微調整したガスクロマトグラフィー/質量分析(GC/MS)(LACO's TitanTest(登録商標)Helium Leak Tester、ユタ州ソルトレークシティー)を用いて注射器の周りの空間を監視した。注射器の周りの領域を真空排気して、ヘリウム濃度を分析し、ヘリウム差圧が15.7psigになった後に1分当たりのヘリウム漏出率を求めた。
注射器に0.96mlの注射用水(WFI)を充填し、通気管止具挿入機を用いて止具を挿入して、摺動力を測定した。用いた注射器は、29ゲージ1/2インチ針を含む杭状針(staked needle)構造であった。止具を動かしたり阻害したりせずに止具に合う適切なプランジャー棒を組み立てた注射器系にはめ込んだ。この系を力変位分析器のホルダーに設置して、クロスヘッドとプランジャー棒の近位端が接触するまでクロスヘッドを25mm/分の速度で動かした。250mm/分の試験速度が確立した後に、力変位データを得た。得られた最大力を記録した。用いた力変位測定器は、TA-270N注射器試験固定部を有するTA XT Plus Texture分析装置(マサチューセッツ州ハミルトン)であった。
ガラス外筒と接合するプランジャーの接触幅は、キーエンスデジタルマイクロメーターVHX-5000(イリノイ州アイタスカ)を用いて各リブを倍率30xで3回測定したものを平均した。
デジタル3点内部マイクロメーター(ミツトヨシリーズ468、イリノイ州オーロラ)を用いて注射器外筒の内径を測定した。
光学測定システム(キーエンスIM6225、イリノイ州アイタスカ)を用いて止具のリブ直径とリブ半径を測定した。
[1]
外筒、プランジャー棒、及び止具(stopper)を含む医療用送達装置であって、
前記外筒は、内面を有し、
前記プランジャー棒は、前記外筒内に挿入された遠位端を有し、
前記止具は、前記プランジャー棒の遠位端に取り付けられて、前記外筒の内面の少なくとも一部と接触すると共に、弾性体と、1つ以上のフッ素重合体層と、封止面を有し、前記1つ以上のフッ素重合体層面に配置された、2つ以上のリブとを含み、
ここで、前記止具の約7.9%超の圧縮率で測定される、前記2つ以上のリブのうちの少なくとも1つと前記外筒の内面の一部との間の接触幅が、約1.0mm未満である、医療用送達装置。
[2]
前記内面は、親水性内面である、項目1に記載の医療用送達装置。
[3]
前記内面は、潤滑剤を含まないか実質的に含まない、項目1に記載の医療用送達装置。
[4]
前記1つ以上のフッ素重合体層は、前記2つ以上のリブに積層される、項目1に記載の医療用送達装置。
[5]
前記止具は、約2.0mm未満の摺動面をさらに含む、項目1に記載の医療用送達装置。
[6]
前記内面は、むき出しのガラスである、項目1に記載の医療用送達装置。
[7]
前記2つ以上のリブの各リブは封止面を有し、前記封止面は、各リブの頂点において約0.22mm未満の曲率半径を有する、項目1に記載の医療用送達装置。
[8]
前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は約1.08より大きい、項目7に記載の医療用送達装置。
[9]
封止面を有する前記リブの最大外径は約5.0mmより大きく、前記外筒の内面の内径は約4.65mm~約11.85mmであり、前記外筒の内面の内径に対する封止面を有する前記リブの最大外径の比は約1.08より大きい、項目7に記載の医療用送達装置。
[10]
前記1つ以上のフッ素重合体層は、圧縮延伸ポリ四フッ化エチレンの単層を含む、項目1に記載の医療用送達装置。
[11]
前記2つ以上のリブの各リブは、各リブの頂点において約0.22mm未満の曲率半径を有する、項目10に記載の医療用送達装置。
[12]
前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は約1.08より大きい、項目11に記載の医療用送達装置。
[13]
封止面を有する前記リブの最大外径は約5.0mmより大きく、前記外筒の内面の内径は約4.65mm~約11.85mmであり、前記外筒の内面の内径に対する封止面を有する前記リブの最大外径の比は約1.08より大きい、項目11に記載の医療用送達装置。
[14]
前記1つ以上のフッ素重合体層は、障壁層及び多孔性層を含むフッ素重合体複合膜を含み、前記障壁層は、圧縮ePTFE、PTFE、フッ化エチレンプロピレン、ポリエチレン、ポリプロピレン、ポリフッ化ビニリデン、ポリフッ化ビニル、ペルフルオロプロピルビニルエーテル、ペルフルオロアルコキシ重合体、並びにこれらの共重合体及び組み合わせから選択される少なくとも1種の材料を含む、項目1に記載の医療用送達装置。
[15]
前記2つ以上のリブの各リブは、各リブの曲率の頂点で約0.22mm未満の曲率半径を有する、項目14に記載の医療用送達装置。
[16]
前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は約1.08より大きい、項目15に記載の医療用送達装置。
[17]
封止面を有する前記リブの最大外径は約5.0mmより大きく、前記外筒の内面の内径は約4.65mm~約11.85mmであり、前記外筒の内面の内径に対する封止面を有する前記リブの最大外径の比は約1.08より大きい、項目15に記載の医療用送達装置。
[18]
遠位端及び止具(stopper)を含むプランジャー棒であって、
前記遠位端は、内面を有する外筒に挿入可能であり、
前記止具は、前記遠位端に取り付けられて、前記外筒の内面の少なくとも一部に接触するように構成されると共に、弾性体と、1つ以上のフッ素重合体層と、前記1つ以上のフッ素重合体層面に配置された2つ以上のリブとを含み、
ここで、封止面を有する前記2つ以上のリブの各リブは、各リブの頂点で約0.22mm未満の曲率半径を有し、前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は、約1.08より大きく、
ここで、前記プランジャー棒は、前記外筒の内面の内径を有する外筒に挿入された場合に、前記止具の約7.9%超の圧縮率で測定される、前記2つ以上のリブのうちの少なくとも1つと前記外筒の内面の一部との間の接触幅が、約1.0mm未満である、プランジャー棒。
[19]
前記内面は、親水性内面である、項目18に記載のプランジャー棒。
[20]
前記内面は、潤滑剤を含まないか実質的に含まない、項目18に記載のプランジャー棒。
[21]
前記1つ以上のフッ素重合体層は、前記2つ以上のリブに積層される、項目18に記載のプランジャー棒。
[22]
前記1つ以上のフッ素重合体層は、圧縮延伸ポリ四フッ化エチレンの単層を含む、項目18に記載のプランジャー棒。
[23]
前記1つ以上のフッ素重合体層は、障壁層及び多孔性層を含むフッ素重合体複合膜を含み、前記障壁層は、圧縮ePTFE、PTFE、フッ化エチレンプロピレン、ポリエチレン、ポリプロピレン、ポリフッ化ビニリデン、ポリフッ化ビニル、ペルフルオロプロピルビニルエーテル、ペルフルオロアルコキシ重合体、並びにこれらの共重合体及び組み合わせより選択される少なくとも1つの材料を含む、項目18に記載のプランジャー棒。
[24]
内面を有する外筒に挿入可能な止具(stopper)であって、
弾性体と、
1つ以上のフッ素重合体層と、
2つ以上のリブとを含み、
ここで、前記2つ以上のリブのうちの少なくとも1つは、前記1つ以上のフッ素重合体層面に配置されて、前記外筒の内面の少なくとも一部と接触するように構成され、
ここで、前記2つ以上のリブの各リブは、各リブの頂点で約0.22mm未満の曲率半径を有し、前記リブのすべての最大外径の前記外筒の内面の内径に対する比は約1.08より大きく、
ここで、前記止具は、前記外筒に挿入された場合に、前記止具の約7.9%超の圧縮率で測定される、前記2つ以上のリブのうちの少なくとも1つと前記外筒の内面の一部との間の接触幅が、約1.0mm未満である、止具。
[25]
前記1つ以上のフッ素重合体層は、前記2つ以上のリブに積層される、項目24に記載の止具。
[26]
前記1つ以上のフッ素重合体層は、圧縮延伸ポリ四フッ化エチレンの単層を含む、項目24に記載の止具。
[27]
前記1つ以上のフッ素重合体層は、障壁層及び多孔性層を含むフッ素重合体複合膜を含み、前記障壁層は圧縮ePTFE、PTFE、フッ化エチレンプロピレン(FEP)、ポリエチレン、ポリプロピレン、ポリフッ化ビニリデン、ポリフッ化ビニル、ペルフルオロプロピルビニルエーテル、ペルフルオロアルコキシ重合体、並びにこれらの共重合体及び混合物より選択される少なくとも1つの材料を含む、項目24に記載の止具。
Claims (27)
- 外筒、プランジャー棒、及び止具(stopper)を含む医療用送達装置であって、
前記外筒は、内面を有し、
前記プランジャー棒は、前記外筒内に挿入された遠位端を有し、
前記止具は、前記プランジャー棒の遠位端に取り付けられて、前記外筒の内面の少なくとも一部と接触すると共に、弾性体と、1つ以上のフッ素重合体層と、封止面を有し、前記1つ以上のフッ素重合体層面に配置された、2つ以上のリブとを含み、
ここで、前記止具の約7.9%超の圧縮率で測定される、前記2つ以上のリブのうちの少なくとも1つと前記外筒の内面の一部との間の接触幅が、約1.0mm未満である、医療用送達装置。 - 前記内面は、親水性内面である、請求項1に記載の医療用送達装置。
- 前記内面は、潤滑剤を含まないか実質的に含まない、請求項1に記載の医療用送達装置。
- 前記1つ以上のフッ素重合体層は、前記2つ以上のリブに積層される、請求項1に記載の医療用送達装置。
- 前記止具は、約2.0mm未満の摺動面をさらに含む、請求項1に記載の医療用送達装置。
- 前記内面は、むき出しのガラスである、請求項1に記載の医療用送達装置。
- 前記2つ以上のリブの各リブは封止面を有し、前記封止面は、各リブの頂点において約0.22mm未満の曲率半径を有する、請求項1に記載の医療用送達装置。
- 前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は約1.08より大きい、請求項7に記載の医療用送達装置。
- 封止面を有する前記リブの最大外径は約5.0mmより大きく、前記外筒の内面の内径は約4.65mm~約11.85mmであり、前記外筒の内面の内径に対する封止面を有する前記リブの最大外径の比は約1.08より大きい、請求項7に記載の医療用送達装置。
- 前記1つ以上のフッ素重合体層は、圧縮延伸ポリ四フッ化エチレンの単層を含む、請求項1に記載の医療用送達装置。
- 前記2つ以上のリブの各リブは、各リブの頂点において約0.22mm未満の曲率半径を有する、請求項10に記載の医療用送達装置。
- 前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は約1.08より大きい、請求項11に記載の医療用送達装置。
- 封止面を有する前記リブの最大外径は約5.0mmより大きく、前記外筒の内面の内径は約4.65mm~約11.85mmであり、前記外筒の内面の内径に対する封止面を有する前記リブの最大外径の比は約1.08より大きい、請求項11に記載の医療用送達装置。
- 前記1つ以上のフッ素重合体層は、障壁層及び多孔性層を含むフッ素重合体複合膜を含み、前記障壁層は、圧縮ePTFE、PTFE、フッ化エチレンプロピレン、ポリエチレン、ポリプロピレン、ポリフッ化ビニリデン、ポリフッ化ビニル、ペルフルオロプロピルビニルエーテル、ペルフルオロアルコキシ重合体、並びにこれらの共重合体及び組み合わせから選択される少なくとも1種の材料を含む、請求項1に記載の医療用送達装置。
- 前記2つ以上のリブの各リブは、各リブの曲率の頂点で約0.22mm未満の曲率半径を有する、請求項14に記載の医療用送達装置。
- 前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は約1.08より大きい、請求項15に記載の医療用送達装置。
- 封止面を有する前記リブの最大外径は約5.0mmより大きく、前記外筒の内面の内径は約4.65mm~約11.85mmであり、前記外筒の内面の内径に対する封止面を有する前記リブの最大外径の比は約1.08より大きい、請求項15に記載の医療用送達装置。
- 遠位端及び止具(stopper)を含むプランジャー棒であって、
前記遠位端は、内面を有する外筒に挿入可能であり、
前記止具は、前記遠位端に取り付けられて、前記外筒の内面の少なくとも一部に接触するように構成されると共に、弾性体と、1つ以上のフッ素重合体層と、前記1つ以上のフッ素重合体層面に配置された2つ以上のリブとを含み、
ここで、封止面を有する前記2つ以上のリブの各リブは、各リブの頂点で約0.22mm未満の曲率半径を有し、前記外筒の内面の内径に対する、封止面を有する前記リブの全ての最大外径の比は、約1.08より大きく、
ここで、前記プランジャー棒は、前記外筒の内面の内径を有する外筒に挿入された場合に、前記止具の約7.9%超の圧縮率で測定される、前記2つ以上のリブのうちの少なくとも1つと前記外筒の内面の一部との間の接触幅が、約1.0mm未満である、プランジャー棒。 - 前記内面は、親水性内面である、請求項18に記載のプランジャー棒。
- 前記内面は、潤滑剤を含まないか実質的に含まない、請求項18に記載のプランジャー棒。
- 前記1つ以上のフッ素重合体層は、前記2つ以上のリブに積層される、請求項18に記載のプランジャー棒。
- 前記1つ以上のフッ素重合体層は、圧縮延伸ポリ四フッ化エチレンの単層を含む、請求項18に記載のプランジャー棒。
- 前記1つ以上のフッ素重合体層は、障壁層及び多孔性層を含むフッ素重合体複合膜を含み、前記障壁層は、圧縮ePTFE、PTFE、フッ化エチレンプロピレン、ポリエチレン、ポリプロピレン、ポリフッ化ビニリデン、ポリフッ化ビニル、ペルフルオロプロピルビニルエーテル、ペルフルオロアルコキシ重合体、並びにこれらの共重合体及び組み合わせより選択される少なくとも1つの材料を含む、請求項18に記載のプランジャー棒。
- 内面を有する外筒に挿入可能な止具(stopper)であって、
弾性体と、
1つ以上のフッ素重合体層と、
2つ以上のリブとを含み、
ここで、前記2つ以上のリブのうちの少なくとも1つは、前記1つ以上のフッ素重合体層面に配置されて、前記外筒の内面の少なくとも一部と接触するように構成され、
ここで、前記2つ以上のリブの各リブは、各リブの頂点で約0.22mm未満の曲率半径を有し、前記リブのすべての最大外径の前記外筒の内面の内径に対する比は約1.08より大きく、
ここで、前記止具は、前記外筒に挿入された場合に、前記止具の約7.9%超の圧縮率で測定される、前記2つ以上のリブのうちの少なくとも1つと前記外筒の内面の一部との間の接触幅が、約1.0mm未満である、止具。 - 前記1つ以上のフッ素重合体層は、前記2つ以上のリブに積層される、請求項24に記載の止具。
- 前記1つ以上のフッ素重合体層は、圧縮延伸ポリ四フッ化エチレンの単層を含む、請求項24に記載の止具。
- 前記1つ以上のフッ素重合体層は、障壁層及び多孔性層を含むフッ素重合体複合膜を含み、前記障壁層は圧縮ePTFE、PTFE、フッ化エチレンプロピレン(FEP)、ポリエチレン、ポリプロピレン、ポリフッ化ビニリデン、ポリフッ化ビニル、ペルフルオロプロピルビニルエーテル、ペルフルオロアルコキシ重合体、並びにこれらの共重合体及び混合物より選択される少なくとも1つの材料を含む、請求項24に記載の止具。
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JP2022129944A Active JP7492996B2 (ja) | 2016-01-15 | 2022-08-17 | 積層型止具を含む医療用送達装置 |
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