JP2020527376A - 薬物容器のためのガス透過性シーリング部材及び組立方法 - Google Patents
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Abstract
Description
2017年7月21日に出願された米国仮特許出願第62/535,777号明細書の優先権の利益が主張され、その内容全体が参照により本明細書に明示的に援用される。
上述したように、容器に薬物を充填することができる。この薬物は、以下に列挙する薬物の任意の1つ又は組み合わせとすることができ、ただし、以下のリストは、全てを包含するようにも限定するようにもみなされるべきではない。
Claims (50)
- ハウジングと、
前記ハウジング内に配置され、且つ内容積及び端部表面を有する容器であって、開口部は、前記端部表面に形成され、且つ前記内容積と連通している、容器と、
前記容器の前記内容積内に配置された薬物と、
基端部と先端部とを含むセプタムであって、前記基端部は、前記開口部を通して前記容器の前記内容積に挿入され、前記先端部は、フランジを含み、前記フランジは、前記基端部の外側に配置され、且つ前記容器の前記端部表面に接触し、前記フランジの少なくとも端部部分は、第1の材料で作製されており、前記先端部の少なくとも一部分は、第2の材料で作製されており、前記第1の材料は、気体滅菌剤を透過させる、セプタムと
を含む薬物送達デバイス。 - 前記フランジの前記端部部分の基端側対向表面は、前記容器の前記端部表面に密閉的に係合して、汚染物質の侵入を阻止する、請求項1に記載の薬物送達デバイス。
- 前記気体滅菌剤は、エチレンオキサイド又は蒸気の少なくとも1つを含む、請求項1又は2に記載の薬物送達デバイス。
- 前記セプタムの前記基端部は、前記第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項1〜3のいずれか一項に記載の薬物送達デバイス。
- 前記セプタムの前記先端部は、前記フランジの前記端部部分以外、完全に前記第2の材料から作製されている、請求項4に記載の薬物送達デバイス。
- 前記フランジの前記端部部分は、滅菌処置中に前記気体滅菌剤に曝される外部周辺表面を有する、請求項4又は5に記載の薬物送達デバイス。
- 前記フランジの前記端部部分の長さは、前記フランジの全長よりも短く、及び前記フランジの前記端部部分の幅は、前記フランジの全幅に等しい、請求項4〜6のいずれか一項に記載の薬物送達デバイス。
- 前記フランジに対して遠位に配置されている前記セプタムの前記先端部の一部分は、第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項1〜3のいずれか一項に記載の薬物送達デバイス。
- 前記セプタムの前記基端部は、前記第1の材料で作製されている、請求項8に記載の薬物送達デバイス。
- 前記フランジの前記端部部分は、滅菌処置中に前記気体滅菌剤に曝される外部周辺表面を有する、請求項8又は9に記載の薬物送達デバイス。
- 前記フランジの前記端部部分の長さは、前記フランジの全長よりも短く、及び前記フランジの前記端部部分の幅は、前記フランジの全幅に等しい、請求項8〜10のいずれか一項に記載の薬物送達デバイス。
- 前記フランジの前記端部部分の前記基端側対向表面及び前記フランジの前記端部部分の外部周辺表面以外に前記セプタムを完全に覆うフルオロポリマーフィルムを含む、請求項2〜11のいずれか一項に記載の薬物送達デバイス。
- 前記セプタムの先端側対向表面と前記容器の外部表面とに係合して、前記フランジを前記容器の前記端部表面に対して固定する締結具を含み、前記締結具は、前記気体滅菌剤を透過させる、請求項1〜12のいずれか一項に記載の薬物送達デバイス。
- 前記セプタムの前記基端部の外側に向かって延び、且つ前記容器の内側表面に密閉的に係合するように構成されている環状リブを含む、請求項1〜13のいずれか一項に記載の薬物送達デバイス。
- 前記ハウジングの外部表面は、患者に取り外し可能に取り付け可能である、請求項1〜14のいずれか一項に記載の薬物送達デバイス。
- 送達部材を、前記ハウジング内の後退位置から、前記ハウジングの外に延びる展開位置に移動させるように構成されている挿入機構を含む、請求項1〜15のいずれか一項に記載の薬物送達デバイス。
- 前記薬物送達デバイスの起動時に前記容器と前記送達部材との間に流体流路を確立するために、前記セプタムを通して挿入可能な中空穿孔部材を含む、請求項1〜16のいずれか一項に記載の薬物送達デバイス。
- 前記薬物送達デバイスの起動時に前記容器から前記薬物を排出するように構成されている駆動機構を含む、請求項1〜17のいずれか一項に記載の薬物送達デバイス。
- 薬物送達デバイスを組み立てる方法であって、
内容積及び端部表面を有する容器であって、開口部は、前記端部表面に形成され、且つ前記内容積と連通している、容器と、
基端部と先端部とを含むセプタムであって、前記基端部は、前記開口部を通して前記容器の前記内容積に挿入され、前記先端部は、フランジを含み、前記フランジは、前記基端部の外側に配置され、且つ前記容器の前記端部表面に接触し、前記フランジの少なくとも端部部分は、第1の材料で作製されており、前記第1の材料は、気体滅菌剤を透過させる、セプタムと
を含む容器アセンブリを提供することと、
気体滅菌剤が前記第1の材料を通して拡散して、前記容器の前記端部表面を滅菌するように、前記容器アセンブリを前記気体滅菌剤で滅菌することと、
前記容器の前記内容積に薬物を充填することと、
前記容器アセンブリを前記薬物送達デバイスに取り付けることと
を含む方法。 - 前記気体滅菌剤は、エチレンオキサイド又は蒸気の少なくとも1つを含む、請求項19に記載の方法。
- 前記セプタムの前記基端部は、第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項19又は20に記載の方法。
- 前記セプタムの前記先端部は、前記フランジの前記端部部分以外、完全に前記第2の材料から作製されている、請求項21に記載の方法。
- 前記セプタムの前記先端部は、完全に前記第1の材料で作製されている、請求項19〜21のいずれか一項に記載の方法。
- 前記セプタムの前記基端部は、前記第1の材料で作製されており、及び前記フランジに対して遠位に配置されている前記セプタムの前記先端部の一部分は、第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項19又は20に記載の方法。
- 前記セプタムは、完全に前記第1の材料で作製されている、請求項19又は20に記載の方法。
- 前記容器アセンブリは、前記容器アセンブリが前記薬物送達デバイスに取り付けられた後、前記気体滅菌剤で滅菌される、請求項19又は20に記載の方法。
- 内容積及び端部表面を有する容器であって、開口部は、前記端部表面に形成され、且つ前記内容積と連通している、容器と、
基端部と先端部とを含むセプタムであって、前記基端部は、前記開口部を通して前記容器の前記内容積に挿入可能であり、前記先端部は、前記基端部の外側に配置されたフランジを含み、前記フランジの少なくとも端部部分は、第1の材料で作製されており、前記先端部の少なくとも一部分は、第2の材料で作製されており、前記第1の材料は、気体滅菌剤を透過させる、セプタムと
を含む容器アセンブリ。 - 前記気体滅菌剤は、エチレンオキサイド又は蒸気の少なくとも1つを含む、請求項27に記載の容器アセンブリ。
- 前記セプタムの前記基端部は、前記第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項27又は28に記載の容器アセンブリ。
- 前記セプタムの前記先端部は、前記フランジの前記端部部分以外、完全に前記第2の材料から作製されている、請求項29に記載の容器アセンブリ。
- 前記セプタムの前記基端部は、前記第1の材料で作製されており、及び前記フランジに対して遠位に配置されている前記セプタムの前記先端部の一部分は、第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項27又は28に記載の容器アセンブリ。
- 前記容器の前記内容積内に摺動可能に配置されたストッパと、前記ストッパと前記セプタムとの間に配置された薬物とを含む、請求項27〜31のいずれか一項に記載の容器アセンブリ。
- 前記フランジの前記端部部分の基端側対向表面及び前記フランジの前記端部部分の外部周辺表面以外に前記セプタムを完全に覆うフルオロポリマーフィルムを含む、請求項27〜32のいずれか一項に記載の容器アセンブリ。
- 前記セプタムの先端側対向表面と前記容器の外部表面とに係合して、前記フランジを前記容器の前記端部表面に対して固定する締結具を含み、前記締結具は、前記気体滅菌剤を透過させる、請求項27〜33のいずれか一項に記載の容器アセンブリ。
- 内容積及び端部表面を有する容器であって、開口部は、前記端部表面に形成され、且つ前記内容積と連通している、容器と、
基端部と先端部とを含むセプタムであって、前記基端部は、前記開口部を通して前記容器の前記内容積に挿入可能であり、前記先端部は、前記基端部の外側に配置されたフランジを含む、セプタムと、
前記フランジと前記容器の前記端部表面との間に配置された環状シーリング部材であって、第1の材料で作製されており、前記第1の材料は、気体滅菌剤を透過させる、環状シーリング部材と
を含む容器アセンブリ。 - 前記気体滅菌剤は、エチレンオキサイド又は蒸気の少なくとも1つを含む、請求項35に記載の容器アセンブリ。
- 前記セプタムの少なくとも一部分は、第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項35又は36に記載の容器アセンブリ。
- 前記セプタムの先端側対向表面と前記容器の外部表面とに係合して、前記フランジと前記容器の前記端部表面との間の前記環状シーリング部材を固定する締結具を含み、前記締結具は、前記気体滅菌剤を透過させる、請求項35〜37のいずれか一項に記載の容器アセンブリ。
- 前記締結具は、前記気体滅菌剤が前記締結具を通過することを可能にするように構成された少なくとも1つの開口部を有する、請求項38に記載の容器アセンブリ。
- 薬物容器のためのセプタムであって、
長手方向軸線と、
前記薬物容器に挿入可能な基端部と、
前記基端部の半径方向外側に配置されたフランジを含む先端部であって、前記フランジは、外部周辺表面及び基端側対向表面を含む、先端部と
を含み、及び
前記フランジの少なくとも端部部分は、第1の材料で作製されており、前記先端部の少なくとも一部分は、第2の材料で作製されており、前記第1の材料は、気体滅菌剤が、前記第1の材料を通して前記フランジの前記外部周辺表面と前記フランジの前記基端側対向表面との間に拡散することを可能にされるように、前記気体滅菌剤を透過させる、セプタム。 - 前記気体滅菌剤は、エチレンオキサイド又は蒸気の少なくとも1つを含む、請求項40に記載のセプタム。
- 前記セプタムの前記基端部は、前記第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項40又は41に記載のセプタム。
- 前記セプタムの前記先端部は、前記フランジの前記端部部分以外、完全に前記第2の材料から作製されている、請求項42に記載のセプタム。
- 前記セプタムの前記基端部は、前記第1の材料で作製されており、及び前記フランジに対して遠位に配置されている前記セプタムの前記先端部の一部分は、第2の材料で作製されており、前記第2の材料は、前記第1の材料よりも透過性が低い、請求項40又は41に記載のセプタム。
- 完全に前記第1の材料で作製されている、請求項40又は41に記載のセプタム。
- 前記フランジの前記基端側対向表面及び前記フランジの前記端部部分の前記外部周辺表面の一部分以外に前記セプタムを完全に覆うフルオロポリマーフィルムを含む、請求項40又は45に記載のセプタム。
- ハウジングと、
前記ハウジング内に配置され、且つ内容積及び端部表面を有する容器であって、開口部は、前記端部表面に形成され、且つ前記内容積と連通している、容器と、
前記容器の前記内容積内に配置された薬物と、
基端部と先端部とを含むセプタムであって、前記基端部は、前記開口部を通して前記容器の前記内容積に挿入され、前記先端部は、フランジを含み、前記フランジは、前記基端部の外側に配置され、且つ前記容器の前記端部表面に接触し、前記セプタムの全体は、気体滅菌剤を透過させる材料で作製されている、セプタムと
を含む薬物送達デバイス。 - 前記フランジの基端側対向表面は、前記容器の前記端部表面に密閉的に係合して、汚染物質の侵入を阻止する、請求項47に記載の薬物送達デバイス。
- 前記気体滅菌剤は、エチレンオキサイド又は蒸気の少なくとも1つを含む、請求項47又は48に記載の薬物送達デバイス。
- 前記フランジの前記基端側対向表面及び前記フランジ47の外部周辺表面の一部分以外に前記セプタムを完全に覆うフルオロポリマーフィルムを含む、請求項47〜49のいずれか一項に記載の薬物送達デバイス。
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EP3655063A1 (en) | 2020-05-27 |
US20210361529A1 (en) | 2021-11-25 |
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EP4292576A2 (en) | 2023-12-20 |
WO2019018169A1 (en) | 2019-01-24 |
IL271173B1 (en) | 2023-12-01 |
MA49626A (fr) | 2020-05-27 |
JP2023113682A (ja) | 2023-08-16 |
IL271173B2 (en) | 2024-04-01 |
IL271173A (en) | 2020-01-30 |
EP4292576A3 (en) | 2024-01-17 |
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