JP2021193384A - Gmrによるバイオマーカの検出におけるサンプル調整のためのシステムおよび方法 - Google Patents
Gmrによるバイオマーカの検出におけるサンプル調整のためのシステムおよび方法 Download PDFInfo
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Abstract
Description
本出願は、米国特許仮出願第62/711,396号(出願日:2018年7月27日)に基づく優先権を主張するものであり、この米国特許出願の開示は、参照により全体として本明細書に組み込まれる。
けられている。前記カートリッジアセンブリはまた、前記空気圧インターフェースを備える。前記空気圧インターフェースは、少なくとも1つの空気圧制御ポートと、前記少なくとも1つの計量チャンバに流体接続された対応する連通チャネルとを備える。前記空気圧インターフェースは、前記カートリッジ読み取り機のオフボード空気圧システムに接続するように構成されており、前記空気圧インターフェースは、前記サンプル処理カードへ正圧および負圧の加圧流体を適用することにより、前記検査サンプルおよび前記1つまたは複数の混合材料を移動させるように構成されている。前記メモリチップは、少なくとも前記検査サンプルを前記サンプル処理カードから前記センサへと送達させるべく、前記空気圧インターフェースに選択的に圧力を印加するための工程および設定を含む空気圧系統プロトコルを格納してもよい。
するためにカートリッジ読み取り機100内の空気圧系統330によって制御される複数のおよび/または一連のバルブを含む。この領域230内の複数のバルブは、サンプル処理カード210内の複数の連通チャネルに接続されてもよい。混合領域とは、分離された検査サンプルを他の液体(試薬、洗浄緩衝液、磁気ビーズ等)と混合および/または移動するために使用される領域を指す。バルブアレイ領域230における(例えば、弾性撓み部分を有する)バルブは開位置と閉位置との間で選択的に制御されることにより、検査サンプルの連通チャネルを通じた選択的送達、例えば、混合領域に設けられた流体計量チャンバ240への送達を可能にし、検査サンプルは、例えば、試薬、緩衝液等と混合される。制御・送達領域は、読み取り機100のカートリッジリーダ310および空気圧系統330と連通するカード210上の領域であり得る。一実施形態では、カード210のチャネル内の流体の動きを制御するための複数のポート235(少なくとも1つの空気圧制御ポート235)が空気圧制御インターフェースに設けられる。いくつかの実施形態では、制御・送達領域はまた、必要に応じてバルブアレイゾーン230内のバルブの位置を制御するためのポートを有してもよい。空気圧制御ポート235はそれぞれ、カード210内の他の特徴(例えば、計量チャンバ)との接続のために、当該ポートに流体接続された対応する連通チャネルを有する。これら領域およびその説明は例示に過ぎず、これに限定することを意図したものではない。
受けるまで上面に引き寄せられでもよい。
330から測定信号を受信した後、信号プロセッサ1330は測定信号を処理して被検物質の検出検査結果を取得する。表示制御ユニットユニット120を介して、検査結果を一体化されたディスプレイまたは外部ディスプレイに表示することができる。更に、信号プロセッサ1330は、ユーザからの命令を受信するためにユーザーインターフェース140に接続されてもよい。いくつかの実施形態では、信号プロセッサ1330は、通信ユニット340および/または診断ユニット350に接続されて、検査結果単独または他の外部の利用可能なデータと組み合わせた評価および診断を可能にしてもよい。
される構造、配置、比率、要素、材料および構成要素に対して様々な変形を加えることが可能であることは当業者であれば理解できる。
Claims (23)
- 検査サンプルを準備し、前記検査サンプル内の被検物質を検知するためのカートリッジアセンブリであって、前記カートリッジアセンブリは、
センサを含む基板と、
前記基板に取り付けられたサンプル処理カードであって、前記サンプル処理カードは、
前記サンプル処理カードの本体内に前記検査サンプルを受け取るためのサンプルポートと、
前記サンプル処理カードのベントポートであって、前記ベントポートは、大気に開放されており、前記サンプル処理カードから空気を排気するように構成されている、ベントポートと、
前記検査サンプルを受け取るための少なくとも1つの計量チャンバと、
前記検査サンプルと、前記サンプル処理カード内のその他の流体とを誘導するための複数のバルブと、
前記検査サンプルを前記センサに送達するために前記少なくとも1つの計量チャンバに流体接続された少なくとも1つの出力ポートと
を含む、サンプル処理カードと
を備え、
前記センサは、前記検査サンプル内の被検物質を検知するように構成されている、カートリッジアセンブリ。 - 前記基板は、読み取り機との電気接続を確立するように構成された電気接点部と、前記サンプル処理カード内の前記検査サンプルの処理に関する情報を格納するためのメモリチップとをさらに含む、請求項1に記載のカートリッジアセンブリ。
- 前記基板は、i)接着剤材料を用いて前記サンプル処理カードに取り付けられているか、ii)前記サンプル処理カードに適用された積層された層であるか、iii)サンプル処理カードに積層されたフレキシブル回路であるか、iv)セラミック材料から製造されているか、またはv)前記サンプル処理カードに機械的に位置合わせされ、接続されている、請求項1または2のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、前記サンプルポートに注入された前記検査サンプルをろ過するためのろ過膜をさらに含む、請求項1〜3のいずれかに記載のカートリッジアセンブリ。
- 前記複数のバルブは、前記サンプル処理カード内の1つ以上の連通チャネルに接続されており、前記バルブの各々は、開位置と閉位置との間で移動するように構成されており、これにより、それぞれ、接続された連通チャネルへの流体連通を開放し、接続された連通チャネルへの流体連通を閉鎖する、請求項1〜4のいずれかに記載のカートリッジアセンブリ。
- 前記複数のバルブの各バルブは、開位置と閉位置との間で移動するように構成されたエラストマー撓み部分を含む、請求項1〜5のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、複数の層を含み、前記少なくとも1つの計量チャンバおよび混合材料源は、同じ層上に設けられている、請求項1〜6のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、複数の層を含み、前記少なくとも1つの計量チャンバは、混合材料源と比較して別個の層上に設けられている、請求項1〜7のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、複数の層を含み、前記少なくとも1つの計量チャンバは、1つ以上の廃棄物チャンバと比較して別個の層上に設けられている、請求項1〜8のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、複数の層を含み、前記少なくとも1つの計量チャンバおよびろ過膜は、同じ層上に設けられている、請求項1〜9のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、複数の層を含み、前記少なくとも1つの計量チャンバおよび前記複数のバルブは、同じ層上に設けられている、請求項1〜10のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、前記サンプル処理カード内に1つ以上の廃棄物チャンバをさらに含み、前記1つ以上の廃棄物チャンバは、1つ以上の連通チャネルを介して、前記少なくとも1つの計量チャンバ、前記センサからの入力ポート、またはそれらの両方のいずれかに流体接続されている、請求項1〜11のいずれかに記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、複数の層を含み、前記1つ以上の廃棄物チャンバおよび前記複数のバルブは、同じ層上に設けられている、請求項12に記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、1つ以上の混合材料を前記少なくとも1つの計量チャンに導入するための混合材料源と、前記サンプルポートおよび前記混合材料源を前記少なくとも1つの計量チャンバに流体接続する流体連通チャネルとをさらに含み、前記少なくとも1つの出力ポートは、前記検査サンプルおよび前記1つ以上の混合材料を前記センサに送達する、請求項1〜13のいずれかに記載のカートリッジアセンブリ。
- 前記センサは、前記少なくとも1つの出力ポートを介して前記検査サンプルおよび前記1つ以上の混合材料を受け取る、請求項14に記載のカートリッジアセンブリ。
- 前記サンプル処理カードは、前記検査サンプルと前記1つ以上の混合材料とを実質的に均質な混合物へと混合するための少なくとも1つの混合チャネルをさらに含み、前記少なくとも1つの混合チャネルは、前記少なくとも1つの計量チャンバに選択的に接続され、前記少なくとも1つの出力ポートを介して前記実質的に均質な混合物を前記センサに送達するように構成されている、請求項14または15に記載のカートリッジアセンブリ。
- 前記少なくとも1つの混合チャネルは、前記サンプル処理カードの縦軸に対して階段状の構成を含む、請求項16に記載のカートリッジアセンブリ。
- 空気圧インターフェースであって、前記空気圧インターフェースは、少なくとも1つの空気圧制御ポートと、前記サンプル処理カードの前記少なくとも1つの計量チャンバに流体接続された対応する連通チャネルとを含む、空気圧インターフェース
をさらに備え、
前記空気圧インターフェースは、読み取り機のオフボード空気圧システムに接続するように構成されており、前記空気圧インターフェースは、前記サンプル処理カードへの正圧および負圧の加圧流体の適用を可能にすることにより、前記検査サンプルおよび1つ以上の混合材料を連通チャネル内で前記センサへと移動させるように構成されており、メモリチップは、前記空気圧インターフェースに圧力を選択的に適用することにより、少なくとも前記検査サンプルを前記サンプル処理カードから前記センサに送達するための工程および設定を含む空気圧系統プロトコルを格納している、請求項1〜17のいずれかに記載のカートリッジアセンブリ。 - 空気圧インターフェースであって、前記空気圧インターフェースは、少なくとも1つの空気圧制御ポートと、前記サンプル処理カードの前記少なくとも1つの計量チャンバに流体接続された対応する連通チャネルとを含む、空気圧インターフェース
をさらに備え、
前記空気圧インターフェースは、読み取り機のオフボード空気圧システムに接続するように構成されており、前記空気圧インターフェースは、前記サンプル処理カードへの正圧および負圧の加圧流体の適用を可能にすることにより、前記検査サンプルを前記センサへと移動させるように構成されている、請求項1〜18のいずれかに記載のカートリッジアセンブリ。 - 前記空気圧インターフェースは、前記サンプル処理カード上に設けられている、請求項18または19の記載のカートリッジアセンブリ。
- 前記空気圧インターフェースは、前記複数のバルブのうちの1つ以上に加圧空気を送達することにより、前記複数のバルブのうちの前記1つ以上を開位置と閉位置との間で移動させるように構成された1つ以上のバルブ制御ポートをさらに含む、請求項18または19に記載のカートリッジアセンブリ。
- カートリッジシステムであって、
カートリッジ読み取り機であって、
請求項1〜21のいずれかに記載のカートリッジアセンブリを受け取るためのカートリッジ受け部と、
インターフェースと、
ディスプレイと
を含む、カートリッジ読み取り機
を備え、
前記カートリッジ読み取り機は、前記検査サンプルを処理し、前記検査サンプルに関するリアルタイムフィードバックを提供するために、前記カートリッジアセンブリを受け取るように構成されている、カートリッジシステム。 - 請求項1〜22のいずれかに記載のカートリッジアセンブリを使用する方法であって、前記方法は、
前記検査サンプルを前記サンプルポートへと注入することと、
読み取り機との電気接続を確立することと、
オフボード空気圧システムを使用して加圧空気を空気圧インターフェースに選択的に適用することにより、前記検査サンプルおよび前記1つ以上の混合材料を連通チャネル内で前記センサへと移動させることと
を含む、方法。
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