JP2022520491A - 無針血管アクセスコネクタのための密封及びクリーンシング装置 - Google Patents
無針血管アクセスコネクタのための密封及びクリーンシング装置 Download PDFInfo
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- JP2022520491A JP2022520491A JP2021549198A JP2021549198A JP2022520491A JP 2022520491 A JP2022520491 A JP 2022520491A JP 2021549198 A JP2021549198 A JP 2021549198A JP 2021549198 A JP2021549198 A JP 2021549198A JP 2022520491 A JP2022520491 A JP 2022520491A
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
- A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
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Abstract
Description
以下の説明は、本発明を理解するのに有用であり得る情報を含む。そのような情報は、いずれも、現在特許請求されている発明に先行技術であるか、または関連していること、または具体的にまたは暗黙に参照されている記載が先行技術であることを容認するものではない。
医療分野、特に、患者への流体の注入または患者からの流体の吸引の分野において、ルアーアクセス装置、例えば、無針弁コネクタ(NC)などの医療装置の汚染されている可能性のある表面からの患者への病原体の伝播を防止する必要性が依然として存在する。病原体には、細菌、真菌、ウイルスなどの微生物が含まれ、その微生物が患者に伝播すると、生命を脅かす可能性のある感染症を引き起こすことがある。医療現場に特化して、「院内感染」という用語は、病院または病院のような状況に由来する、または発生する感染を意味する。米国では、院内感染は全ての急性期入院の少なくとも5%で発生すると推定されている。推定発生率は年間200万例以上であり、重大な罹患率、死亡率、および経費をもたらす。実際、院内感染はあらゆる入院患者の死亡率と罹患率のリスクの2倍以上と見積もられており、米国だけでも年間約100,000人が死亡する可能性が高い。患者の血流中への汚染微生物の伝播のための一般的な部位は、ルアーアクセス装置、バイアル、無針(または無針)弁、ならびに容器、チューブ、およびカテーテルの注入口などの医療装置上に見出される。患者におけるこのような感染症の発生率は増加しており、感染管理開業医(ICP)は、しばしばこのような感染症の主要な感染源として、部位の不適切な洗浄を挙げている。
本発明を詳細に説明する前に、本発明の文脈で使用されるいくつかの用語を定義する。これらの用語に加えて、他の用語は、必要に応じて、本明細書の他の箇所で定義される。本明細書中で特に明確に定義されない限り、本明細書中で使用される技術用語は、それらの技術的に認識された意味を有する。
以下の詳細な説明では、その一部を形成する添付の図面(図1~10)を参照する。図において、同様の記号は、文脈が別段の指示をしない限り、典型的には同様の構成要素を識別する。詳細な説明、図面、および特許請求の範囲に記載される例示的な実施形態は、限定することを意味しない。本明細書に提示される主題の精神または範囲から逸脱することなく、他の実施形態を利用することができ、他の変化を行うことができる。
本発明の特定の好ましい代表的な実施形態をさらに例示し、説明するために、リーダは、本発明の密封および洗浄装置の様々な特に好ましい実施形態を例示する添付の図面、図1~10を対象とする。これらの好ましい代表的な実施形態について以下に説明する。
Claims (12)
- ねじ切りされた弁部分を有する無針脈管アクセスコネクタ用の密封および洗浄装置であって、
(a) 無針脈管アクセスコネクタの前記ねじ切りされた弁部分に当該装置をねじ込み、かつ、前記弁部分から当該装置のねじを緩めることができるように構成された内側筐体と、
(b) 前記内部筐体が配置されるキャビティを備えて、前記内部筐体を保持及び係合するように構成されるが、前記内部筐体に係合されないときには前記内部筐体から独立して回転することができる外側筐体と、
(c) 前記外側筐体内に保持され、前記外側筐体と共に回転して、任意で消毒剤、任意選択で70%イソプロピルアルコール溶液で含浸される、圧縮可能な洗浄マトリックスと、
を備える装置。 - 請求項1に記載の装置であって、外部環境から内部を封止する取り外し可能な封止体をさらに備える、装置。
- 請求項1に記載の装置であって、前記洗浄試薬は、任意で70%イソプロピルアルコール溶液であるイソプロピルアルコールを含む、装置。
- 請求項1に記載の装置であって、前記外側筐体は複数の垂直リッジを有する外側表面を含む、装置。
- 無針脈管アクセスコネクタを洗浄する方法であって、
(a) 請求項1に記載の密封および洗浄装置へ無針脈管アクセスコネクタを接続することで、前記コネクタの1つ以上の表面が前記圧縮可能な洗浄マトリックスと係合して前記圧縮可能な洗浄マトリックスの一部を圧縮する段階と、
(b) 必要な場合には、前記外側筐体を前記内側筐体に対して回転可能にして、前記外側筐体を前記内側筐体及び前記コネクタに対して回転させることで、前記圧縮可能な洗浄マトリックスによって接続される前記表面を洗浄する段階と、
を有する方法。 - 請求項5に記載の方法であって、洗浄後に当該密封および洗浄装置へ接続される無針脈管アクセスコネクタを外すことで前記無針脈管アクセスコネクタを密封する段階をさらに有する、方法。
- ねじ切りされた弁部分を有する無針脈管アクセスコネクタ用の密封および洗浄装置であって、
内側筐体と、外側筐体と、圧縮可能な洗浄マトリックスを備え、
前記内側筐体は、上端および下端で開口する中心ボアを形成する実質的に円筒形状の側壁と、外側筐体係合領域と、任意で内側筐体保持領域を備え、
無針血管アクセスコネクタを保持し、必要に応じて、無針コネクタを解放するように、無針血管アクセスコネクタのねじ付き弁部分と係合するように構成された1つ以上のねじ係合タブまたはねじ山が前記下端開口に近接し、かつ、前記中心ボア上に配置され、
前記外側筐体係合領域は、当該装置の外側筐体の機械的係合および係合解除を可能にするように構成され、
前記外側筐体保持領域は、前記外側筐体係合領域が係合解除されたときに、前記外側筐体の空洞内での前記内側筐体の保持、及び、前記外側筐体の前記内側筐体に対する回転を可能にするように構成され、
前記外側筐体は、外壁と上壁とによって形成されたキャビティと、任意で同心のマトリックスウェルと、前記内側筐体を前記キャビティ内に解放可能に係合及び保持するように構成された1つ以上の係合および保持構造とを備え、
前記係合構造が前記内側筐体と係合すると、前記内側筐体と前記外側筐体は、一体とって回転することができ、前記係合構造が前記内側筐体から係合解除されると、前記外側筐体は、前記内側筐体に対して回転することが可能で、
前記圧縮可能な洗浄マトリックスは、内部に配置され、前記外側筐体のマトリックスウェルに固定された洗浄試薬を含み、
前記マトリックスは、当該装置が前記コネクタに固定され、かつ、前記外側筐体および前記マトリックスが前記内側筐体に対して回転されるときに、無針血管アクセスコネクタの1つ以上の表面に接触及び洗浄するように構成され、
前記洗浄試薬は、任意で70%イソプロピルアルコール溶液である、
装置。 - 請求項7に記載の装置であって、外部環境から内部を封止する取り外し可能な封止体をさらに備える、装置。
- 請求項7に記載の装置であって、前記洗浄試薬は、任意で70%イソプロピルアルコール溶液であるイソプロピルアルコールを含む、装置。
- 請求項7に記載の装置であって、前記外側筐体は複数の垂直リッジを有する外側表面を含む、装置。
- 無針脈管アクセスコネクタを洗浄する方法であって、
(a) 請求項7に記載の密封および洗浄装置へ無針脈管アクセスコネクタを接続することで、前記コネクタの1つ以上の表面が前記圧縮可能な洗浄マトリックスと係合して前記圧縮可能な洗浄マトリックスの一部を圧縮する段階と、
(b) 必要な場合には、前記外側筐体を前記内側筐体に対して回転可能にして、前記外側筐体を前記内側筐体及び前記コネクタに対して回転させることで、前記圧縮可能な洗浄マトリックスによって接続される前記表面を洗浄する段階と、
を有する方法。 - 請求項11に記載の方法であって、洗浄後に当該密封および洗浄装置へ接続される無針脈管アクセスコネクタを外すことで前記無針脈管アクセスコネクタを密封する段階をさらに有する、方法。
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JP2024037783A (ja) | 2024-03-19 |
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CA3130950A1 (en) | 2020-08-27 |
AU2020225386B2 (en) | 2022-03-10 |
AU2022204713A1 (en) | 2022-07-21 |
CN114401765A (zh) | 2022-04-26 |
WO2020172346A1 (en) | 2020-08-27 |
EP3927415A1 (en) | 2021-12-29 |
MA55036A (fr) | 2021-12-29 |
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EP3927415A4 (en) | 2022-11-02 |
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