JP2022517847A - 一体化されたスワブ及び検査デバイスを有する有害汚染物質採取デバイス - Google Patents
一体化されたスワブ及び検査デバイスを有する有害汚染物質採取デバイス Download PDFInfo
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Abstract
Description
この出願は、これにより引用によってその全体が組み込まれる2019年1月28日出願の米国仮特許出願第62/797,804号の利益を主張するものである。
本発明の開示の実施形態は、癌治療に使用される抗癌薬等であるがこれに限定されない有害環境汚染物質を汚染物質への検査オペレータの露出を最小にしながら検出するためのシステム及び技術に関する。そのような検査のためのキットは、採取デバイスと検査デバイスを含むことができる。本発明の開示を通して例示的システム、キット、及び方法を抗癌剤の採取、検査、及び検出に関して以下に説明するが、本発明の技術は、着目するあらゆる粒子、分子、又は検体を採取、検査、及び検出するのに使用することができることは理解されるであろう。
で与えられる正確な薬物濃度測定値を取得するのに重要である可能性があるいくつかのファクタがある。上式中のCは濃度であり、αは、汚染面密度(ng/ft^2)であり、Aは、拭き取り及び検査されている表面積であり、ηpは捕捉効率であり、ηeは、スワブ密度からの抽出であり、Vbは、汚染物質を抽出して検査ストリップに搬送することを支援するのに使用される緩衝溶液の流体容積である。本説明の検査の目標は、低い変動しか伴わない高濃度信号を有することとすることができる。変数の過度の「ノイズ」又は変動は、検査に偽陽性又は偽陰性のいずれかの結果を生成する場合がある。本明細書に説明する検査キットは、上述の濃度式中の各項の変動を低減することを支援するための機構及び/又はユーザへの指図を含むことができる。
図1は、図2A~図2C及び図4A~図6Eに示すもの等であるがこれらに限定されない本発明の開示によるシステム汚染物質採取デバイスを使用した検査方法100の例示的段階を示している。図1の描いたブロックのうちの1つ、一部、又は全ては、アッセイキット及び/又は採取キットのパッケージング又は指図資料上にグラフィカル指図として印刷することができ、又はアッセイ読取器デバイス、検査区域端末、又はユーザのパーソナルコンピュータデバイスの表示画面のグラフィカルユーザインタフェース上に提示することができる。
本明細書に説明するように、本発明の開示による汚染物質採取デバイスは、液密移送機構によるスワブ材料からアッセイ検査ストリップへの流体の移送を意味する「閉じたシステム」とすることができる。例えば、スワブ材料と検出デバイス(検査ストリップのような)は、スワブ材料と検査ストリップ(及び採取デバイスのいずれかの介在流路)の間の液密シールを提供するためにハウジング内で互いに流体的に結合することができる。有益なことに、害を及ぼす流体、薬物、又は蒸気をそのような採取デバイス内に完全に閉じ込めて、場合によってユーザに害を与えることになる雰囲気中への発散又は採取器と検査デバイスの間の移送中の溢流を起こさないとすることができる。液密は、採取キットが検出するように設計される汚染物質の特性に依存して液体不透過性、ガス又は蒸気の不透過性、又は両方を有することを意味することができる。有益なことに、液密は、キットのユーザに対する採取デバイスの流体内の潜在的な汚染物質からの保護を提供することができる。
図7は、例示的アッセイ読取器デバイス700の構成要素の1つの可能な実施形態の概略ブロック図を示している。これらの構成要素は、メモリ715、作業メモリ755、カートリッジ読取器735、接続性モジュールインタフェース745、及びディスプレイ750にリンクされ、かつこれらと電子通信しているプロセッサ710を含むことができる。
本発明の開示の態様は、汚染検査データ管理システムに関する。病院及び他のヘルスケア提供環境には、薬物調製システム、面汚染検査、及びヘルスケア従事者安全手順がある。これら3つの分野は、有害薬物へのヘルスケア従事者の露出を低減又は排除し、患者に適正な薬物投与量が与えられることを保証するという共通の目標を有するという点でのみ結び付けられる。本説明の有害汚染検出のキット、システム、及び技術は、これら3つの分野と、感知パターン及び傾向と、意図する従事者のフィードバック及び訓練とをリンクさせることによって既存手法を改善する。投与量調製、職員の活動、及び汚染検査結果に関するデータ間の関係を確立して分析することにより、本発明の開示のシステムは、ヘルスケア従事者及び経営側にリスクの識別、フィードバック、及び訓練を意図する情報を提供することができる。有益な成果は、検査区域内の露出リスクを低減するための挙動及び/又はワークフローの変化を含むことができる。
本明細書に開示する実施は、抗癌剤又は他の環境汚染物質の存在及び/又は量の検出のためのシステム、方法、及び装置を提供する。当業者は、これらの実施形態をハードウエア、又はハードウエアとソフトウエアの組合せ、及び/又はファームウエアに実施することができることを認識されるであろう。
Claims (25)
- エンクロージャを形成する細長本体と、
前記エンクロージャ内に配置されたアッセイ検査ストリップであって、有害汚染物質の存在下で光検出可能な外見変化を生成するように構成された反応ゾーンを含む前記アッセイ検査ストリップと、
前記細長本体に結合された吸収性スワブ材料であって、該スワブ材料が、前記有害汚染物質を検査面から持ち上げるように構成された溶液で湿潤され、該細長本体が、該吸収性スワブ材料に結合された第1の端部と、該第1の端部から離間した第2の端部と、それらの間を延びる細長長さとを有するハンドルを形成する前記吸収性スワブ材料と、
前記吸収性スワブ材料と前記検査ストリップの間に流体通路を含む液密エンクロージャと、
を備える採取デバイス、
を備える、有害汚染物質検査システム。 - 前記細長本体の前記第1の端部を密封するように構成されたキャップを更に備える、請求項1に記載の有害汚染物質検査システム。
- 前記キャップは、
前記有害汚染物質を前記吸収性スワブ材料から洗い流すように構成された流体を閉じ込めるリザーバと、
前記キャップが前記細長本体に付加された時に前記リザーバと該細長本体の前記第1の端部の間に位置決めされる易壊性シールと、
を備える、
請求項2に記載の有害汚染物質検査システム。 - 前記キャップは、前記易壊性シールに結合されたスワブ受け入れ部材を含み、
前記スワブ受け入れ部材は、前記キャップが前記細長本体に第1の向きに付加された時に前記吸収性スワブ材料が該スワブ受け入れ部材に入らないように、かつ該キャップが該細長本体に第2の向きに付加された時に該吸収性スワブ材料が該スワブ受け入れ部材に入るように構成され、
前記吸収性スワブ材料は、前記キャップが前記細長本体に前記第2の向きに付加された時に前記易壊性シールを破断するように構成される、
請求項3に記載の有害汚染物質検査システム。 - 前記キャップは、起動された時に前記易壊性シールを開封して前記流体を前記吸収性スワブ材料の中に放出するポンプを含む、請求項3に記載の有害汚染物質検査システム。
- 前記吸収性スワブ材料と前記アッセイ検査ストリップは、材料の単一片から形成され、
前記流体通路は、前記吸収性スワブ材料と前記反応ゾーンの間を延びる前記材料の領域を備える、
請求項1に記載の有害汚染物質検査システム。 - 前記流体通路は、前記吸収性スワブ材料と前記アッセイ検査ストリップのサンプル受け入れゾーンとを流体的に結合するチャネルを備える、請求項1に記載の有害汚染物質検査システム。
- 前記アッセイ検査ストリップは、前記サンプル受け入れゾーンと前記反応ゾーンの間を延びるある長さの材料を含み、
前記長さの材料は、前記サンプル受け入れゾーンに受け入れられた液体を前記反応ゾーンまで吸い上げるように構成される、
請求項7に記載の有害汚染物質検査システム。 - 前記アッセイ検査ストリップの幅が、前記スワブ材料の幅と異なっている、請求項1に記載の有害汚染物質検査システム。
- 前記吸収性スワブ材料の一部分が、前記細長本体の遠位端から出て延びる、請求項1に記載の有害汚染物質検査システム。
- 単一構造が、前記採取デバイスの第1の領域と第2の領域の間の密封流体通路を含み、該採取デバイスは、該デバイスの第1の領域に有害汚染物質を受け入れ、該有害汚染物質を該流体通路に沿って該第2の領域まで下流に移動し、かつ該有害汚染物質を該デバイスの該第2の領域に結合する、請求項1に記載の有害汚染物質検査システム。
- 前記反応ゾーンから反射された光を受光するように位置決めされ、かつ該受光した光の強度を表す信号を発生させるように構成された画像センサと、
前記信号を分析して前記反応ゾーンでの前記有害汚染物質の存在を決定するように構成された制御電子機器と、
を備える検出デバイス、
を更に備える、請求項1に記載の有害汚染物質検査システム。 - エンクロージャを形成する細長本体と、
前記エンクロージャ内に配置されたアッセイ検査ストリップであって、有害汚染物質の存在下で光検出可能な外見変化を生成するように構成された反応ゾーンを備える前記アッセイ検査ストリップと、
前記細長本体に結合された吸収性スワブ材料であって、該スワブ材料が、前記有害汚染物質を検査面から持ち上げるように構成された溶液で湿潤され、該細長本体が、該吸収性スワブ材料に結合された第1の端部と、該第1の端部から離間した第2の端部と、それらの間を延びる細長長さとを有するハンドルを形成する前記吸収性スワブ材料と、
前記吸収性スワブ材料と前記検査ストリップの間の流体通路を備える液密エンクロージャと、
を備える、有害汚染物質採取デバイス。 - 前記細長本体の前記第1の端部を密封するように構成されたキャップを更に備える、請求項13に記載の有害汚染物質採取デバイス。
- 前記キャップは、
前記有害汚染物質を前記吸収性スワブ材料から洗い流すように構成された流体を閉じ込めるリザーバと、
前記キャップが前記細長本体に付加された時に前記リザーバと該細長本体の前記第1の端部の間に位置決めされる易壊性シールと、
を備える、
請求項14に記載の有害汚染物質採取デバイス。 - 前記キャップは、前記エンクロージャを密封して液密チャンバを生成するように構成される、請求項15に記載の有害汚染物質採取デバイス。
- 前記キャップは、前記易壊性シールに結合されたスワブ受け入れ部材を含み、
前記スワブ受け入れ部材は、前記キャップが前記細長本体に第1の向きに付加された時に前記吸収性スワブ材料が該スワブ受け入れ部材に入らないように、かつ該キャップが該細長本体に第2の向きに付加された時に該吸収性スワブ材料が該スワブ受け入れ部材に入るように構成され、
前記吸収性スワブ材料は、前記キャップが前記細長本体に前記第2の向きに付加された時に前記易壊性シールを破断するように構成される、
請求項15に記載の有害汚染物質採取デバイス。 - 前記キャップは、起動された時に前記易壊性シールを開封して前記流体を前記吸収性スワブ材料の中に放出するポンプを含む、請求項15に記載の有害汚染物質採取デバイス。
- 前記吸収性スワブ材料と前記アッセイ検査ストリップは、材料の単一片から形成され、
前記液密流体通路は、前記吸収性スワブ材料と前記反応ゾーンの間を延びる前記材料の領域を備える、
請求項13に記載の有害汚染物質採取デバイス。 - 前記液密流体通路は、前記吸収性スワブ材料と前記アッセイ検査ストリップのサンプル受け入れゾーンとを流体的に結合するチャネルを備える、請求項13に記載の有害汚染物質採取デバイス。
- 前記アッセイ検査ストリップは、前記サンプル受け入れゾーンと前記反応ゾーンの間を延びるある長さの材料を含み、
前記長さの材料は、前記サンプル受け入れゾーンから受け入れた液体を前記反応ゾーンまで吸い上げるように構成される、
請求項20に記載の有害汚染物質採取デバイス。 - 有害汚染物質の存在に関して検査面を検査する方法であって、
採取デバイスの細長本体からキャップを取り外して該細長本体の端部に結合された吸収性スワブ材料を露出させる段階であって、該吸収性スワブ材料が、前記有害汚染物質を前記検査面から持ち上げるように構成された溶液の第1の容積で事前湿潤される前記露出させる段階と、
前記検査面を前記吸収性スワブ材料で拭き取って該検査面から前記有害汚染物質を採取する段階と、
前記細長本体に前記キャップを再度付加して前記吸収性スワブ材料を密封し、前記採取した有害汚染物質を前記採取デバイス内に隔離する段階と、
ある容積の液体を前記吸収性スワブ材料から前記採取デバイス内に密封されたアッセイ検査ストリップまで該採取デバイス内の液密経路を通じて移送する段階と、
前記アッセイ検査ストリップをアッセイ読取器デバイスの中に挿入する段階と、
前記アッセイ読取器デバイスの出力に基づいて、前記有害汚染物質が前記検査面上に存在することを識別する段階と、
を含む方法。 - 前記キャップは、前記緩衝溶液の第2の容積を閉じ込めるリザーバを含み、
前記方法が、前記緩衝溶液の前記第2の容積を前記吸収性スワブ材料の中に放出する段階を更に含む、
請求項22に記載の方法。 - 前記キャップは、前記スワブ材料が前記リザーバの易壊性シールに接触しない第1の向きに前記細長本体に最初に付加され、
前記緩衝溶液の前記第2の容積を放出する段階は、前記スワブ材料が前記易壊性シールに対して押圧してそれを開封する第2の向きに前記キャップを前記細長本体の上に押圧する段階を含む、
請求項23に記載の方法。 - 前記キャップのポンプ機構を起動して前記緩衝溶液の前記第2の容積を前記吸収性スワブ材料の中に放出する段階を更に含む、請求項23に記載の方法。
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CA3125355A1 (en) | 2020-08-06 |
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EP3918300A4 (en) | 2022-11-16 |
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AU2020215639A1 (en) | 2021-08-05 |
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