JP6971988B2 - 医用診断モニタリングおよびスクリーニングに用いられるモバイルデバイスベースの多検体検査アナライザ - Google Patents
医用診断モニタリングおよびスクリーニングに用いられるモバイルデバイスベースの多検体検査アナライザ Download PDFInfo
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Description
本発明は、一般に体液検査システムに関するものであり、より詳しくは、医用診断モニタリングおよびスクリーニングに用いられるモバイルデバイスベースの多検体検査アナライザに関するものである。
正確かつ詳細な医療情報を提供するために、体液サンプル内の各種検体濃度を検出する体液検査システムが用いることができる。かかる情報は、糖尿病などの特定の病状の診断および/または治療を補助するために使用できる。例えば、糖尿病モニタリング用途では、高(すなわち高血糖)または低(すなわち低血糖)血糖値を検出するために、糖尿病患者または医師がアナライザを使用できる。モニタされた値は、異常な値をユーザに通知することによって、糖尿病の治療および管理に役立てることができ、これにより、ユーザは、砂糖またはインスリン摂取を増加させるなど、血糖値を安定化させるために必要な調整を行うことができる。別の例として、糖化ヘモグロビンとも呼ばれるHbA1cは、長期間の平均血漿グルコース濃度を取り込むので、糖尿病のモニタリングおよびスクリーニングの両方に使用される検体である。他の例は、他の慢性の病に対してより一般的な検体である。かかる例には、血液、尿および唾液などの様々な体液中で測定できる、脂質(総コレステロール、HDLコレステロール、LDLコレステロールおよびトリグリセリド)、血清クレアチニン、ヘモグロビンおよびケトンが含まれる。現在、医療診断のモニタリングおよびスクリーニングに使用されるいくつかのシステムおよび方法が存在する。
本発明は、概して、反射率ベースの比色試験片読取装置からのデータを制御および処理するためのユーザインターフェースとして、モバイルデバイスアプリケーションを使用して、体液中の検体濃度を測定するシステムおよび方法に関する。
本発明の実施形態は、添付図面に関連した、本発明の様々な実施形態の以下の詳細な説明を考慮することにより、より完全に理解されるであろう。
以下の詳細な説明は、図面を参照して読まれるべきであり、異なる図面における同様の要素には同じ番号が付与されている。必ずしも縮尺通りである必要のない図面は、例示的な実施形態を示しており、特許請求された発明の範囲を限定することを意図するものではない。
本件出願は、以下の構成の発明を提供する。
(構成1)
試験片長手方向軸を有する試験片を取り外し可能に受け入れるように構成され、ジャックプラグ受容ソケットを有するモバイルデバイスと共に使用するための、反射率ベースの比色測定試験片読取装置であって;
ハウジング;
該ハウジングに動作可能に連結すると共に、ジャックプラグ軸に沿って該ハウジングから延出し、該ジャックプラグ受容ソケットと動作可能に連結するように構成されたジャックプラグ;
試験片受容チャネル軸を示す試験片受容チャネルを定義する構造を含み、該ハウジングに動作可能に、取り外し可能に連結される試験片アダプタ;
該試験片受容チャネルによって、運ばれたときに該試験片が照明されるように、該試験片アダプタが該ハウジングに動作可能に連結されているときに、該試験片受容チャネルに向かって光を導くために、該ハウジング内に配置された光源;及び
該試験片受容チャネルによって、運ばれる試験片から反射された光を検知するために該ハウジング内に配置された光センサを備える、該試験片読取装置。
(構成2)
前記光源は、前記反射面からの光を前記試験片受取チャネルに導くために、傾斜した反射面に近接して前記ハウジング内に等間隔に角度をつけて配置された2つの発光ダイオードを備え、
前記光センサは、前記試験片から反射された光を検知するために、前記ハウジング内の該2つの発光ダイオードの間に配置されている、構成1に記載の試験片読取装置。
(構成3)
前記2つの発光ダイオードは、第1の色の第1の発光ダイオードと、第2の色の第2の発光ダイオードと、を備える、構成2に記載の試験片読取装置。
(構成4)
前記光源が3つ以上の発光ダイオードを備える、構成2に記載の試験片読取装置。
(構成5)
前記試験片受容チャネル軸は、前記試験片アダプタが前記ハウジングに連結されているときに、前記ジャックプラグ軸に沿って略整列配置しており、
その結果試験片は、前記試験片アダプタが前記ハウジングに動作可能に連結されているときに、前記試験片アダプタによって、受け容れ可能であり、
前記試験片長手方向軸は、前記ジャックプラグ軸と略同軸である、構成1に記載の試験片読取装置。
(構成6)
前記試験片読取装置の表面上に配置された試験片スイッチをさらに備え、該試験片スイッチは、起動時に前記試験片読取装置の電源をオンにするように構成される、構成5に記載の試験片読取装置。
(構成7)
制御回路をさらに備え、該制御回路は、測定された光強度に対応する信号を生成するように構成され、該信号は、処理のために前記モバイルデバイスに送信される、構成1に記載の試験片読取装置。
(構成8)
モバイルデバイスと動作可能に連結された反射率ベースの比色測定試験片読取装置を利用して検体濃度を測定する方法であって;
試験片上に体液サンプルを受け取るステップ;
試験片受容チャネルへの該試験片の挿入に応答して、該試験片の反応領域を照らすために光源を作動させるステップ;
該試験片のカラープロファイル変化に基づいて該体液サンプルの検体濃度を決定するステップ;及び
該モバイルデバイスに該検体濃度に対応する信号を送信するステップを含む、該方法。
(構成9)
前記光源を作動させるステップは、構成プロファイルに対応する前記モバイルデバイスからの信号を受信するステップを含み、
該構成プロファイルは、使用中に前記光源のパラメータを変更するために動的に更新される、構成8に記載の方法。
(構成10)
前記構成プロファイルは、記憶媒体に記憶されることを特徴とする構成9に記載の方法。
(構成11)
前記構成プロファイルは、前記モバイルデバイスを介してサーバからダウンロードされることを特徴とする構成9に記載の方法。
(構成12)
前記検体濃度を決定するステップは、前記カラープロファイル変化を光学的に評価するために光センサを利用するステップを含み、
前記光センサは、測定された反射光強度に対応する信号を生成することを特徴とする構成8に記載の方法。
(構成13)
前記体液サンプルを受け取るステップが、血液、尿、および唾液からなる群から選択される体液サンプルを受け取るステップを含む、構成8に記載の方法。
(構成14)
前記検体濃度を前記モバイルデバイスのグラフィカルユーザインターフェース上に表示するステップをさらに含む、構成8に記載の方法。
(構成15)
ハウジングと、ジャックプラグと、試験片受容チャネルを含む試験片アダプタと、光学サブシステムとを有し、モバイルデバイスと通信可能に連結される試験片読取装置を使用する方法であって;
該試験片受容チャネルへの該試験片の挿入に応答して、該試験片の反応領域を照らすために光源を作動させるステップ;
該光学サブシステムの光源を利用して該試験片の反応領域を照射するステップ;
該試験片上に付着した体液サンプルを検出するステップ;
該試験片のカラープロファイル変化に基づいて該体液サンプルの検体濃度を決定するステップ;及び
該検体濃度に対応する信号を該モバイルデバイスに送信するステップを含む、該方法。
(構成16)
前記試験片読取装置の電源を入れるステップをさらに含み、
該試験片読取装置の電源を入れるステップは、前記試験片読取装置の表面上に配置された試験片スイッチをトグルするステップを含む、構成15に記載の方法。
(構成17)
前記検体濃度に対応する前記信号を処理して、前記モバイルデバイスのグラフィカルユーザインターフェース上に表示するステップをさらに含む、構成15に記載の方法。
(構成18)
ハウジング、ジャックプラグ、試験片アダプタ、および光学サブシステムを含む試験片読取装置をユーザに提供するステップ、及び該試験片読取装置を用いて検体分析試験を行うための使用方法を該ユーザに提供するステップを含む方法であって;
該使用方法は、
該試験片読取装置をモバイルデバイスに連結するステップ;
該試験片を該試験片アダプタのアダプタチャネルに挿入するステップ;
該試験片上に体液サンプルを受け取るステップ;
該試験片読取装置に該体液サンプルの検体濃度を測定させるステップ;及び
グラフィカルユーザインターフェース上に表示するために、該試験片読取装置に、該検体濃度に対応するデータを該モバイルデバイスに送信させるステップを含む、該方法。
(構成19)
前記検体分析試験を行うための前記使用方法は、前記モバイルデバイスに、前記試験片読取装置に構成プロファイルを送信させるステップをさらに含む、構成18に記載の方法。
(構成20)
前記検体分析試験を行うための前記使用方法は、前記試験片読取装置の装置ばらつきを補償するために装置特性評価を実行するステップをさらに含む、構成18に記載の方法。
Claims (7)
- 試験片長手方向軸を有する試験片を取り外し可能に受け入れるように構成され、ジャックプラグ受容ソケットを有するモバイルデバイスと共に使用するための、反射率ベースの比色測定試験片読取装置であって、
ハウジング;
該ハウジングに動作可能に連結すると共に、ジャックプラグ軸に沿って該ハウジングから延出し、該ジャックプラグ受容ソケットに挿入されるように構成されたジャックプラグ、ここで該ジャックプラグは、オス型のコネクタである;
該ハウジングに動作可能に、取り外し可能に連結されるように構成されたモジュール式形状を有する試験片アダプタであって、該試験片アダプタが該ジャックプラグ軸と同軸である該試験片長手方向軸を有する該ハウジングと物理的、電気的に接続された場合に、該試験片が該試験片アダプタによって受け入れ可能となるように、該試験片アダプタが該ハウジングに連結されているときに、該ジャックプラグ軸に沿って並列配置している試験片受容チャネル軸を示す試験片受容チャネルを定義する構造を含む、前記試験片アダプタ;
該試験片が該試験片受容チャネルによって運ばれたときに照明されるように、該試験片アダプタが該ハウジングに連結されているときに、光を該試験片受容チャネルに向けて導くために、該ハウジング内に配置された光源であって、該ハウジング内に配置され、該光源から等間隔離れて互いに角度的に変位している少なくとも2つの発光ダイオードを含む、前記光源、
ここで、該少なくとも2つの発光ダイオードの各々が、反射面からの光を該試験片受容チャネルに向けて導くための、対応する傾斜した反射面に近接して配置される;
該試験片受容チャネルによって運ばれる該試験片から反射された光を検知するための、該ハウジング内に配置された光センサであって、該試験片から反射された光を検知するために該ハウジング内の該少なくとも2つの発光ダイオードの間に配置されている、前記光センサ;及び
該ジャックプラグを介して該モバイルデバイスからの制御シーケンスを受け入れ、該制御シーケンスに応答して該光源を制御し、該制御シーケンスの間該光センサからの測定された光強度に対応する信号を連続的に生成し、かつ処理のために該モバイルデバイスに該信号を送信するように構成された、制御回路、を含む、前記試験片読取装置。 - 前記傾斜した反射面の各々が、その対応する発光ダイオードから放出される光線によって規定される方向に対して15-45度の角度で傾斜して、二次元平面に投影されたときに10-30 mmの長さである、前記発光ダイオードからその対応する傾斜した反射面を介して前記試験片に送り、かつ前記光センサに返す光路に沿って、光を該反射面から前記試験片受容チャネルに向けて導く、請求項1記載の試験片読取装置。
- 前記少なくとも2つの発光ダイオードは、第1の色の第1の発光ダイオードと、第2の色の第2の発光ダイオードと、を備える、請求項1に記載の試験片読取装置。
- 前記光源が3つ以上の前記発光ダイオードを備える、請求項1に記載の試験片読取装置。
- 前記制御シーケンスが、前記制御回路に指令して、前記少なくとも2つの発光ダイオードの点滅、期間、順序、または輝度のうちの少なくとも1つを変化させる点滅シーケンスを含む、請求項1に記載の試験片読取装置。
- 前記試験片読取装置の表面上に配置された試験片スイッチをさらに備え、該試験片スイッチは、起動時に該試験片読取装置の電源をオンにするように構成される、請求項1に記載の試験片読取装置。
- 前記制御回路が、構成プロファイルに対応する前記モバイルデバイスからの信号を受信するようにさらに構成され、ここで該構成プロファイルは、前記制御シーケンスの間に前記光源のパラメータを変更するために動的に更新される、請求項1に記載の試験片読取装置。
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