JP2017503599A - 統合された隔膜アクチュエータ保持具を備えるポート付カテーテルアダプタ - Google Patents
統合された隔膜アクチュエータ保持具を備えるポート付カテーテルアダプタ Download PDFInfo
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Abstract
Description
Claims (20)
- 近位端、遠位端、及びそれらの間に延在する内腔を有するカテーテルアダプタであって、当該カテーテルアダプタの側壁を通り内腔と連通する経路を形成する側部ポートをさらに備えるカテーテルアダプタ、
当該内腔内に配置され、当該内腔を近位チャンバーと遠位チャンバーとに分割する血液制御隔膜、
外径を有して、当該近位チャンバー内に配置され、基部と先端部とそれらの間に延在する本体とを有する隔膜アクチュエータであって、先端部は当該血液制御隔膜に近接して配置されており、基部は当該カテーテルアダプタの近位端に近接して位置されている隔膜アクチュエータ、
外径を有し、当該本体の外表面に配置されるアクチュエータ保持タブ、及び
内腔内に配置され、当該内腔と側部ポートの経路との間にシールを形成するバルブであって、当該バルブは、当該隔膜アクチュエータの外径より大きく、且つ当該アクチュエータ保持タブの外径よりも小さい内径を備えた保持リングを有し、当該アクチュエータ保持タブは当該血液制御隔膜と当該アクチュエータ保持リングとの間で当該本体の外表面に位置されているバルブ、
を備えることを特徴とするポート付カテーテルアセンブリ。 - 当該バルブは、当該内腔の内径とほぼ同じ大きさの外径を有する可撓性チューブを備え、それによって、当該バルブが締まり嵌めにより当該内腔内に保持されていることを特徴とする請求項1に記載のアセンブリ。
- 当該カテーテルアダプタの近位端は、別の器具が当該隔膜アクチュエータの基部に接触し、当該血液制御隔膜のスリットを通して当該隔膜アクチュエータの先端を前進させるべく挿入され得る開口部をさらに備えることを特徴とする請求項1に記載のアセンブリ。
- 基部は、当該アクチュエータ保持リングの内径よりも大きい外径を有することを特徴とする請求項1に記載のアセンブリ。
- 当該アクチュエータ保持リングは、複数の通気部をさらに備えることを特徴とする請求項4に記載のアセンブリ。
- 基部が当該保持リングに接触するとき、当該隔膜アクチュエータの先端は隔膜のスリットを通って前進され、且つ基部と当該アクチュエータ保持リングとの間の界面は、当該隔膜アクチュエータの先端がスリットを通ってさらに前進するのを防ぐように、当該アクチュエータ保持リングと基部との間に第一の距離をさらに備えることを特徴とする請求項1に記載のアセンブリ。
- 当該第一の距離は、当該アクチュエータ保持タブが当該アクチュエータ保持リングに接触しているとき、当該隔膜アクチュエータの先端の最遠位表面と当該血液制御隔膜の最遠位表面との間の第二の距離にほぼ等しい、ことを特徴とする請求項6に記載のアセンブリ。
- 当該隔膜アクチュエータ保持タブに塗布された抗菌コーティングをさらに備え、当該隔膜アクチュエータ保持タブは、当該カテーテルアダプタの内腔を通る流体経路内に位置されていることを特徴とする請求項1に記載のアセンブリ。
- 当該抗菌コーティングは、二酢酸クロルヘキシジン、グルコン酸クロルヘキシジン、アレキシジン、スルファジアジン銀、酢酸銀、クエン酸水和物、セトリミド、セチルピリジニウムクロライド、塩化ベンザルコニウム、o-フタルアルデヒド及び銀元素からなる群から選択される抗菌剤を含むことを特徴とする請求項8に記載のアセンブリ。
- 当該抗菌コーティングは、溶出抗菌コーティングを含み、それによって当該溶出抗菌コーティングが当該カテーテルアダプタの内腔の流体内で阻害ゾーンを提供していることを特徴とする請求項8に記載のアセンブリ。
- 当該保持リングは、当該バルブの近位端からなることを特徴とする請求項1に記載のアセンブリ。
- 当該保持リングは、側部ポートと当該カテーテルアダプタの遠位開口部との間の位置で当該カテーテルアダプタ内に位置されていることを特徴とする請求項1に記載のアセンブリ。
- ポート付カテーテルアセンブリを製造する方法であって、
近位端、遠位端、及びそれらの間に延在する内腔を有するカテーテルアダプタを提供するステップ、
当該カテーテルアダプタの側壁に側部ポートを配置し、当該カテーテルアダプタの側壁を貫通して内腔と連絡する経路を形成するステップ、
当該内腔内に血液制御隔膜を配置して、当該内腔を近位チャンバーと遠位チャンバーに分割するステップ、
当該内腔の当該近位チャンバー内に、隔膜アクチュエータであって、基部、先端部、及びそれらの間に延在する本体を有し、当該先端部は当該血液制御隔膜に近接して位置され、且つ当該基部はカテーテルアダプタの近位端に近接して位置されていて、外径をさらに備えている隔膜アクチュエータを配置するステップ、
当該本体の外表面に、外径を有するアクチュエータ保持タブを位置決めするステップ、そして
当該内腔内に、バルブであって、当該隔膜アクチュエータの外径よりも大きく、当該アクチュエータ保持タブの外径よりも小さい内径を備える保持リングを有しているバルブを配置して、当該内腔と側部ポートの経路との間にシールを形成するステップ、を備え、
当該アクチュエータ保持タブが、当該血液制御隔膜と当該アクチュエータ保持リングとの間の本体の外表面に位置されていることを特徴とする方法。 - 当該隔膜の保持タブは内腔の流体経路内に配置されており、当該隔膜の保持タブに抗菌コーティングを塗布するステップをさらに備えることを特徴とする請求項13に記載の方法。
- 当該抗菌コーティングは、二酢酸クロルヘキシジン、グルコン酸クロルヘキシジン、アレキシジン、スルファジアジン銀、酢酸銀、クエン酸水和物、セトリミド、セチルピリジニウムクロライド、塩化ベンザルコニウム、o-フタルアルデヒド及び銀元素からなる群から選択される抗菌剤を備えることを特徴とする請求項14に記載の方法。
- 当該抗菌コーティングは溶出抗菌コーティングからなり、当該溶出抗菌コーティングは、当該カテーテルアダプタの内腔の流体内に阻害のゾーンを提供することを特徴とする請求項14に記載の方法。
- 当該アクチュエータ保持リングに複数の通気部を設けるステップをさらに含むことを特徴とする請求項13に記載の方法。
- 隔膜アクチュエータの外表面を受入れ、それに固定的に取り付けられるべく構成された内表面と、
当該内表面の反対側にカテーテルアダプタの内腔の流体経路と連通して位置された外表面であって、当該カテーテルアダプタのアクチュエータ保持リングの内径よりも大きい外径を有する外表面とを備え、
それによって、アクチュエータ保持タブが、当該アクチュエータ保持リングを通過することを防止されることを特徴とするアクチュエータ保持タブ器具。 - 外表面に塗布された抗菌コーティングをさらに含むことを特徴とする請求項18に記載の器具。
- 当該抗菌コーティングは、二酢酸クロルヘキシジン、グルコン酸クロルヘキシジン、アレキシジン、スルファジアジン銀、酢酸銀、クエン酸水和物、セトリミド、セチルピリジニウムクロライド、塩化ベンザルコニウム、o-フタルアルデヒド及び銀元素からなる群から選択された抗菌剤を溶出し、それにより、カテーテルアダプタの内腔の流体内に阻害ゾーンを提供することを特徴とする請求項19に記載の器具。
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