JP2022514652A - 生物学的インジケータを用いた液体化学滅菌システム - Google Patents
生物学的インジケータを用いた液体化学滅菌システム Download PDFInfo
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Abstract
Description
本明細書に開示される主題は、特に内視鏡滅菌に適用されるような、液体化学滅菌ルーチンの妥当性を評価するための器械および技術に関する。
医療装置は、典型的には使用前に滅菌されて、対象に感染症を引き起こし得る、汚染された装置が対象に使用され得る可能性を最小にする。ガスプラズマおよびエチレンオキシド(EtO)を伴うかまたは伴わない、蒸気、過酸化水素、および気相滅菌などの様々な滅菌技術を使用することができる。
本明細書には、バイアル、バイアル内に配置されたキャリア、および流体管理システムを含む、滅菌システムが開示される。流体管理システムは、バイアルに液体を送達するためにバイアルに接続可能な出力を含む。そのような液体には、少なくとも、液体化学滅菌剤(例えば、過酢酸)および中和剤(例えば、メタ重亜硫酸ナトリウム)が含まれる。したがって、流体管理システムは、液体化学滅菌剤の供給源と、中和剤の供給源と、を含むことができる。滅菌システムは、流体管理システムの出力に接続された針を有する第1のセグメントと、バイアルを収容するキャビティを有する第2のセグメントと、を含む器具をさらに含み得る。第1のセグメントおよび第2のセグメントは、ヒンジによって接続され得、ヒンジを中心として第1のセグメントが回転すると、針がバイアルを貫通する。バイアルは、やはり針によって貫通され得るカバーを含むことができる。内腔を有する医療装置(例えば、内視鏡)を、針と出力との間に接続することができる。
以下の詳細な説明は、異なる図面における同様の要素に同一の番号が付されている図面を参照して読むべきである。必ずしも縮尺どおりではない図面は、選択された実施形態を描いており、本発明の範囲を限定することを意図しない。詳細な説明は、限定としてではなく、例として、本発明の原理を示している。この説明は、当業者が本発明を製造および使用することを明らかに可能にし、本発明を実施するための最良の形態であると現在考えられているものを含む、本発明のいくつかの実施形態、適応形、変形例、代替物および使用を説明する。
(1) 滅菌システムであって、
バイアルと、
前記バイアル内に配置されたキャリアと、
前記バイアルに液体を送達するために前記バイアルに接続可能な出力を有する流体管理システムであって、前記流体管理システムは、
液体化学滅菌剤の供給源、および、
中和剤の供給源、
を含む、流体管理システムと、
を含む、滅菌システム。
(2) 器具をさらに含み、前記器具は、
前記出力に接続された針を含む第1のセグメントと、
前記バイアルを収容するキャビティを含む第2のセグメントと、
ヒンジであって、前記ヒンジを中心として前記第1のセグメントが回転すると、前記針が前記バイアルを貫通するように、前記第1のセグメントを前記第2のセグメントに接続する、ヒンジと、
を含む、実施態様1に記載の滅菌システム。
(3) 前記針と前記出力との間に接続された内腔を有する医療装置をさらに含む、実施態様2に記載の滅菌システム。
(4) 前記医療装置は、内視鏡を含む、実施態様3に記載の滅菌システム。
(5) 増殖培地を収容する第2のバイアルを収容する第2のキャビティをさらに含む、実施態様2に記載の滅菌システム。
(7) 前記器具は、前記キャビティに隣接して配置された加熱要素をさらに含む、実施態様6に記載の滅菌システム。
(8) 前記液体化学滅菌剤は、過酢酸を含む、実施態様6に記載の滅菌システム。
(9) 前記増殖培地は、α-MUGを含む、実施態様8に記載の滅菌システム。
(10) 前記キャリアは、ゲオバチルス・ステアロサーモフィルス胞子を含む、実施態様9に記載の滅菌システム。
(12) キャビティおよび針を有する器具を含む滅菌システムによって滅菌された医療装置の無菌性を判定する方法であって、
微生物のキャリアを収容するバイアルを前記キャビティに挿入するステップと、
前記針を前記バイアル内に貫通させるステップと、
液体化学滅菌剤を、前記針を通して前記バイアル内に導入するステップと、
前記液体化学滅菌剤が中に配置された前記バイアルをインキュベートするステップと、
前記針を通して前記バイアルから前記液体化学滅菌剤を引き出すステップと、
前記針を通して前記バイアルに中和剤を導入するステップと、
前記針を通して前記バイアルから前記中和剤を引き出すステップと、
前記針を通して前記バイアル内に増殖培地を導入するステップと、
前記増殖培地が中に配置された前記バイアルをインキュベートするステップと、
を含む、方法。
(13) 前記増殖培地の視覚的特徴をモニターするステップをさらに含む、実施態様12に記載の方法。
(14) 前記視覚的特徴の変化を判定するステップをさらに含む、実施態様13に記載の方法。
(15) 前記視覚的特徴は、蛍光強度を含む、実施態様13に記載の方法。
(17) 前記増殖培地が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約50℃~約60℃の温度に加熱するステップを含む、実施態様16に記載の方法。
(18) 前記増殖培地が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約57℃に加熱するステップを含む、実施態様17に記載の方法。
(19) 前記液体化学滅菌剤が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約30℃~約50℃の温度に加熱するステップを含む、実施態様17に記載の方法。
(20) 前記液体化学滅菌剤が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約35℃に加熱するステップを含む、実施態様19に記載の方法。
(22) 前記液体化学滅菌剤は、過酢酸を含む、実施態様20に記載の方法。
(23) 前記医療装置は、内視鏡を含む、実施態様16に記載の方法。
Claims (23)
- 滅菌システムであって、
バイアルと、
前記バイアル内に配置されたキャリアと、
前記バイアルに液体を送達するために前記バイアルに接続可能な出力を有する流体管理システムであって、前記流体管理システムは、
液体化学滅菌剤の供給源、および、
中和剤の供給源、
を含む、流体管理システムと、
を含む、滅菌システム。 - 器具をさらに含み、前記器具は、
前記出力に接続された針を含む第1のセグメントと、
前記バイアルを収容するキャビティを含む第2のセグメントと、
ヒンジであって、前記ヒンジを中心として前記第1のセグメントが回転すると、前記針が前記バイアルを貫通するように、前記第1のセグメントを前記第2のセグメントに接続する、ヒンジと、
を含む、請求項1に記載の滅菌システム。 - 前記針と前記出力との間に接続された内腔を有する医療装置をさらに含む、請求項2に記載の滅菌システム。
- 前記医療装置は、内視鏡を含む、請求項3に記載の滅菌システム。
- 増殖培地を収容する第2のバイアルを収容する第2のキャビティをさらに含む、請求項2に記載の滅菌システム。
- 前記流体管理システムは、増殖培地の供給源をさらに含む、請求項2に記載の滅菌システム。
- 前記器具は、前記キャビティに隣接して配置された加熱要素をさらに含む、請求項6に記載の滅菌システム。
- 前記液体化学滅菌剤は、過酢酸を含む、請求項6に記載の滅菌システム。
- 前記増殖培地は、α-MUGを含む、請求項8に記載の滅菌システム。
- 前記キャリアは、ゲオバチルス・ステアロサーモフィルス胞子を含む、請求項9に記載の滅菌システム。
- 前記バイアルは、カバーを含む、請求項1に記載の滅菌システム。
- キャビティおよび針を有する器具を含む滅菌システムによって滅菌された医療装置の無菌性を判定する方法であって、
微生物のキャリアを収容するバイアルを前記キャビティに挿入するステップと、
前記針を前記バイアル内に貫通させるステップと、
液体化学滅菌剤を、前記針を通して前記バイアル内に導入するステップと、
前記液体化学滅菌剤が中に配置された前記バイアルをインキュベートするステップと、
前記針を通して前記バイアルから前記液体化学滅菌剤を引き出すステップと、
前記針を通して前記バイアルに中和剤を導入するステップと、
前記針を通して前記バイアルから前記中和剤を引き出すステップと、
前記針を通して前記バイアル内に増殖培地を導入するステップと、
前記増殖培地が中に配置された前記バイアルをインキュベートするステップと、
を含む、方法。 - 前記増殖培地の視覚的特徴をモニターするステップをさらに含む、請求項12に記載の方法。
- 前記視覚的特徴の変化を判定するステップをさらに含む、請求項13に記載の方法。
- 前記視覚的特徴は、蛍光強度を含む、請求項13に記載の方法。
- ある量の前記液体化学滅菌剤を前記医療装置の内腔に通してから、前記量の前記滅菌剤を前記バイアル内に導入するステップをさらに含む、請求項14に記載の方法。
- 前記増殖培地が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約50℃~約60℃の温度に加熱するステップを含む、請求項16に記載の方法。
- 前記増殖培地が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約57℃に加熱するステップを含む、請求項17に記載の方法。
- 前記液体化学滅菌剤が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約30℃~約50℃の温度に加熱するステップを含む、請求項17に記載の方法。
- 前記液体化学滅菌剤が中に入った前記バイアルをインキュベートするステップは、前記バイアルを約35℃に加熱するステップを含む、請求項19に記載の方法。
- 前記滅菌システムは、複数の流体供給源、チューブ、弁、およびポンプを含み、前記方法は、前記流体供給源、前記チューブ、前記弁、および前記ポンプのうちの少なくともいくつかを、前記液体化学滅菌剤で滅菌するステップをさらに含む、請求項19に記載の方法。
- 前記液体化学滅菌剤は、過酢酸を含む、請求項20に記載の方法。
- 前記医療装置は、内視鏡を含む、請求項16に記載の方法。
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CN113453728B (zh) | 2023-07-21 |
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JP2024059705A (ja) | 2024-05-01 |
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CA3124009A1 (en) | 2020-06-25 |
US11850320B2 (en) | 2023-12-26 |
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US20240033385A1 (en) | 2024-02-01 |
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CN113543760A (zh) | 2021-10-22 |
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WO2020128975A1 (en) | 2020-06-25 |
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