JP2015512628A - 統合された移送モジュールを有する試験カートリッジ - Google Patents
統合された移送モジュールを有する試験カートリッジ Download PDFInfo
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- JP2015512628A JP2015512628A JP2014561469A JP2014561469A JP2015512628A JP 2015512628 A JP2015512628 A JP 2015512628A JP 2014561469 A JP2014561469 A JP 2014561469A JP 2014561469 A JP2014561469 A JP 2014561469A JP 2015512628 A JP2015512628 A JP 2015512628A
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Abstract
Description
(分野)
本発明の実施形態は、臨床診断ツールの分野に関する。
分子試験および免疫アッセイ技法の自動化の複雑性を前提として、患者近傍試験環境において臨床的に使用可能な適正な性能を提供する、製品が欠けている。典型的分子試験は、正確な用量の試薬、試料導入、DNAまたはRNAを抽出するための細胞の溶解、精製ステップ、およびその後続検出のための増幅を伴う、種々のプロセスを含む。これらのプロセスを自動化する、中央検査室ロボットプラットフォームが存在するが、短いターンアラウンドタイムを要求する多くの試験のために中央検査室は、必要とされる時間要件において結果を提供することができない。
臨床診断プラットフォームは、種々の分析試験プロセスを統合し、誤差、コスト、および試験時間を削減することができる。
具体的構成および配列が論じられるが、これは、例証的目的のためだけに行なわれることを理解されたい。当業者は、他の構成および配列も、本発明の精神および範囲から逸脱することなく、使用されることができることを認識するであろう。本発明はまた、種々の他の用途において採用されることができることも、当業者に明白となるであろう。
図1−4は、ある実施形態による、種々の図および試験カートリッジシステムの構成要素を図示する。図1は、カートリッジ筐体102と、移送モジュール104とを含む、試験カートリッジシステム100を図示する。他の構成要素も同様に、分析器モジュールあるいはポンプまたはヒータ等の種々の能動的構成要素等、試験カートリッジシステム100内への含有のためにも検討され得る。
図5−8は、別の実施形態による、試験カートリッジシステムの種々の図および構成要素を図示する。図5A−5Bは、カートリッジ筐体502と、移送モジュール504とを含む、試験カートリッジシステム500の分解表現の図を図示する。移送モジュール504は、実質的に、第1の試験カートリッジ実施形態の移送モジュール104とシステム内に同一の機能を有する。移送モジュール504、104は両方とも、いくつかの実施形態によると、システム内で側方に移動し、移送モジュールの外部上のポートと筐体502、102の側面上のポートを整列させる。さらに、移送モジュール504は、外被508によって囲繞され、蓋506によって冠着された内部チャンバを有する、内側筐体510を伴う、移送モジュール104と類似構造を有する。移送モジュール504のさらなる詳細は、図7A−Dを参照して後述される。
カートリッジ筐体の実施形態およびその対応する移送チャンバの両方の種々のチャンバ間で流体移送を行なうための例示的方法が、以下に説明される。
ここで、試験カートリッジシステム100を使用して行なわれるべき2つの例示的プロトコルについて、論じられる。第1の例示的プロトコルは、リアルタイムPCR検出を対象とする一方、第2の例示的プロトコルは、免疫アッセイを対象とする。本明細書に列挙されるステップは、システムを使用し、各試験を行なうための可能性として考えられる実施例を提供することを理解されたい。
例示的PCRプロトコルは、カートリッジ筐体102の周囲の多数の処理チャンバならびに反応チャンバを利用する。一実施例では、PCRプロトコルは、図2Aに図示されるカートリッジ筐体実施形態を使用する。プロトコルはまた、図6A−6Bに図示されるカートリッジ筐体実施形態を使用して行なわれてもよいことを理解されたい。本実施例では、5つの貯蔵チャンバが使用され、それぞれ、事前に装填された溶液を含有する。貯蔵チャンバは、以下のように標識される。
例示的免疫アッセイは、カートリッジ筐体102の周囲の貯蔵チャンバならびに種々の処理チャンバのうちの少なくとも3つを利用する。一実施例では、免疫アッセイは、図2Bに図示されるカートリッジ筐体実施形態を使用する。PCRプロトコルと同様に、貯蔵チャンバは、アッセイを行なうための事前に装填された溶液を含有する。加えて、特異的捕捉抗体が、検出チャンバ226内に固定化され、結合部位を着目抗原に提供してもよい。蛍光標識された抗体もまた、凍結乾燥された状態で反応チャンバ224内に事前装填されてもよい。本実施例では、貯蔵チャンバは、以下のように標識される。
Claims (69)
- システムであって、前記システムは、
カートリッジ筐体であって、前記カートリッジ筐体は、
少なくとも1つの試料入口と、
複数の貯蔵チャンバと、
複数の反応チャンバと、
前記少なくとも1つの試料入口、前記複数の貯蔵チャンバの少なくとも一部、および前記複数の反応チャンバの少なくとも一部を前記カートリッジ筐体の内側表面上に位置する第1の複数のポートに接続する流体ネットワークと
を備える、カートリッジ筐体と、
前記カートリッジ筐体内に配置された中空移送モジュールであって、前記中空移送モジュールは、前記移送モジュールの中心チャンバにつながる、前記移送モジュールの外側表面に沿った第2の複数のポートを備え、前記移送モジュールは、前記カートリッジ筐体の長さに沿って側方に移動するように構成され、前記移送モジュールの側方移動は、前記第1の複数のポートの少なくとも一部と前記第2の複数のポートの少なくとも一部を整列させる、中空移送モジュールと
を備える、システム。 - 前記カートリッジ筐体はさらに、複数の処理チャンバを備え、前記流体ネットワークはまた、前記複数の処理チャンバの少なくとも一部を前記第1の複数のポートに接続する、請求項1に記載のシステム。
- 前記複数の処理チャンバは、前記カートリッジ筐体の側面表面に沿って位置する、請求項2に記載のシステム。
- 前記カートリッジ筐体と前記中空移送モジュールとの間の界面によって形成された一式の弁チャネルをさらに備える、請求項1に記載のシステム。
- 前記中空移送モジュールの外側表面は、リッジを備える、請求項1に記載のシステム。
- 前記リッジは、トロイド形状を有する、請求項5に記載のシステム。
- 前記リッジは、前記第1の複数のポートのうちの少なくとも2つと整列し、流体が、前記第1の複数のポートのうちの前記少なくとも2つ間を流動することを可能にするように構成されている、前記移送モジュールの外側表面上の面積を画定する、請求項5に記載のシステム。
- 前記リッジは、前記移送モジュールを介して、前記流体ネットワークに連結された複数の弁領域を画定する、請求項5に記載のシステム。
- 前記弁領域は、前記試料入口、前記複数の貯蔵チャンバ、前記複数の反応チャンバ、および前記中心チャンバの中に液体試料の移送経路を画定するように構成されている、請求項8に記載のシステム。
- 前記複数の貯蔵チャンバのうちの少なくとも1つは、前記貯蔵チャンバを通気させるように構成された開口部を含む、請求項1に記載のシステム。
- 前記カートリッジ筐体の側面表面に沿って位置する複数の予混合チャンバをさらに備える、請求項1に記載のシステム。
- 前記複数の貯蔵チャンバ、前記複数の反応チャンバ、および前記複数の予混合チャンバのうちの少なくとも1つ内に密閉された1つ以上の試薬をさらに備える、請求項11に記載のシステム。
- 前記1つ以上の試薬は、凍結乾燥される、請求項12に記載のシステム。
- 前記複数の貯蔵チャンバは、前記カートリッジ筐体の上部表面に沿って位置する、請求項1に記載のシステム。
- 前記複数の反応チャンバは、前記カートリッジ筐体の側面表面に沿って位置する、請求項1に記載のシステム。
- 前記カートリッジ筐体はさらに、前記複数の反応チャンバの下方に位置する1つ以上の光学アクセス窓を備える、請求項15に記載のシステム。
- 前記複数の貯蔵チャンバを密閉する第1のフィルムと、前記複数の反応チャンバを密閉する複数のフィルムとをさらに備える、請求項1に記載のシステム。
- 前記複数の貯蔵チャンバを密閉する前記第1のフィルムは、熱的に制御された表面と接触している、請求項17に記載のシステム。
- 前記複数の反応チャンバを密閉する前記複数のフィルムは、熱的に制御された表面と接触している、請求項17に記載のシステム。
- 前記熱的に制御された表面の温度は、熱電システムによって影響される、請求項19に記載のシステム。
- 前記熱的に制御された表面の温度は、抵抗加熱システムによって影響される、請求項19に記載のシステム。
- 前記熱的に制御された表面の温度は、空気の加熱または冷却のいずれかによって影響される、請求項19に記載のシステム。
- 前記少なくとも1つの試料入口は、スワブを介して、試料を受容するように定寸されている、請求項1に記載のシステム。
- 前記少なくとも1つの試料入口は、固体および液体試料を受容するように構成されている、請求項1に記載のシステム。
- 前記カートリッジ筐体はさらに、少なくとも1つの空気入口ポートを備える、請求項1に記載のシステム。
- 前記少なくとも1つの空気入口ポートは、外部加圧源に接続するように構成されている、請求項25に記載のシステム。
- 前記少なくとも1つの空気入口ポートに連結されたフィルタをさらに備える、請求項25に記載のシステム。
- 前記少なくとも1つの空気入口ポートに連結され、前記液体が前記少なくとも1つの空気入口ポートを通して逃散する前に、液体を保持するように構成されている、バッファチャンバをさらに備える、請求項25に記載のシステム。
- 前記中空移送モジュールは、線形アクチュエータを介して、側方に移動するように構成されている、請求項1に記載のシステム。
- 前記線形アクチュエータは、離散ステップ間で前記移送モジュールを移動させるように構成されている、請求項29に記載のシステム。
- 前記カートリッジ筐体はさらに、前記システムを分析器内の中心に設置するための手段を備える、請求項1に記載のシステム。
- 前記第2の複数のポートのうちの少なくとも1つは、実質的に、前記中心チャンバ内の最下点に位置する、請求項1に記載のシステム。
- 前記中心チャンバの壁は、前記第2の複数のポートのうちの前記少なくとも1つを通して、前記中心チャンバ内の液体を適正に排出するように傾斜されている、請求項32に記載のシステム。
- 前記カートリッジ筐体はさらに、前記流体ネットワークに連結されたフィルタを備える、請求項1に記載のシステム。
- 前記フィルタは、ケイ酸マトリクスである、請求項34に記載のシステム。
- 前記フィルタは、複数のシリカビーズを備える、請求項34に記載のシステム。
- 前記中心チャンバ内に配置された撹拌棒をさらに備える、請求項1に記載のシステム。
- 前記カートリッジ筐体はさらに、複数の液体感知面積を備える、請求項1に記載のシステム。
- 液体の存在は、光学センサを使用して、前記液体感知面積において検出される、請求項38に記載のシステム。
- 前記カートリッジ筐体はさらに、前記流体ネットワークに連結された複数のフリットを備える、請求項1に記載のシステム。
- 液体試料を貯蔵および移送するように構成された移送モジュールであって、前記移送モジュールは、
中心チャンバを封入する内側筐体と、
前記内側筐体の周囲に形成された外被であって、前記外被は、
前記外被の外側表面に沿うパターン化されたリッジであって、前記パターン化されたリッジは、前記移送モジュールが前記パターン化されたリッジと接触する封入体内に配置されると、前記外被の外側表面に沿って複数の弁領域を画定するように構成されている、パターン化されたリッジと、
前記外被および前記内側筐体を通して、前記中心チャンバ内に延在する複数のポートと
を備える、外被と
を備え、
前記複数の弁領域のうちの1つは、前記複数の弁領域内の他の領域と別個に加圧されるように構成されている、移送モジュール。 - 前記複数の弁領域のうちの1つが加圧されると、前記複数のポートのうちの1つ以上を介して、前記中心チャンバの内外いずれかに流体の流動が生じる、請求項41に記載の移送モジュール。
- 前記パターン化されたリッジはさらに、前記移送モジュールを実質的に囲繞する筐体の少なくとも2つのポートと整列する、前記外被の外側表面上の面積を画定し、流体が前記少なくとも2つのポート間を流動することを可能にするように構成されている、請求項41に記載の移送モジュール。
- 前記内側筐体および前記外被は、単一射出成形ユニットとして形成されている、請求項41に記載の移送モジュール。
- 前記複数のポートは、前記移送モジュールの側面に沿って、かつ前記移送モジュールの上部に沿って配列されている、請求項41に記載の移送モジュール。
- 複数の前記パターン化されたリッジは、トロイド形状を有する、請求項41に記載の移送モジュール。
- 前記複数のポートのうちの少なくとも1つは、実質的に、前記中心チャンバ内の最下点に位置する、請求項41に記載の移送モジュール。
- 前記中心チャンバの壁は、前記複数のポートのうちの前記少なくとも1つを通して、前記中心チャンバ内の液体を適正に排出するように傾斜されている、請求項47に記載の移送モジュール。
- 前記中心チャンバ内に配置された撹拌棒をさらに備える、請求項41に記載の移送モジュール。
- 前記中心チャンバの一端を密閉するように構成され、前記中心チャンバ内に傾斜構造を有する蓋をさらに備える、請求項41に記載の移送モジュール。
- 前記傾斜構造は、前記中心チャンバ内の液体を前記複数のポートのうちの1つ以上に指向させるように構成された複数のチャネルを備える、請求項50に記載の移送モジュール。
- 方法であって、前記方法は、
移送モジュールを側方に平行移動させ、中心チャンバを有する前記移送モジュールの第1のポートを第1のチャンバのポートに整列させることと、
第1の圧力差を介して、試料を前記第1のチャンバから前記中心チャンバ内に引き込むことと、
前記移送モジュールを側方に平行移動させ、前記移送モジュールの第2のポートを第2のチャンバのポートに整列させることと、
第2の圧力差を介して、前記試料を前記中心チャンバから前記第2のチャンバ内に引き込むことと
を含む、方法。 - 前記第1のチャンバ内に導入された前記試料と前記第1のチャンバ内に配置されたバッファを混合することをさらに含む、請求項52に記載の方法。
- 前記第1のチャンバから前記中心チャンバ内に引き込まれた前記試料と前記中心チャンバ内に既に存在する液体を混合することをさらに含む、請求項52に記載の方法。
- 前記試料を担持するスワブを介して、前記試料を前記第1のチャンバに導入することをさらに含む、請求項52に記載の方法。
- 前記第2のチャンバ内の試料を処理することと、
第3の圧力差を介して、前記試料を前記第2のチャンバから前記中心チャンバ内に引き込むことと、
前記移送モジュールを側方に平行移動させ、前記移送モジュールの第2のポートを第3のチャンバのポートに整列させることと、
第4の圧力差を介して、前記試料を前記中心チャンバから前記第3のチャンバ内に引き込むことと、
前記第3のチャンバ内にある間、前記試料の1つ以上の品質を測定することと
をさらに含む、請求項52に記載の方法。 - 測定することは、蛍光信号を光学的に測定することを含む、請求項56に記載の方法。
- 測定することは、吸収率を光学的に測定することを含む、請求項56に記載の方法。
- 前記試料を前記第2のチャンバ内に引き込んだ後、または前記試料を前記第3のチャンバ内に引き込んだ後のいずれかにおいて、前記試料を加熱することをさらに含む、請求項56に記載の方法。
- 前記移送モジュールを側方に平行移動させることを繰り返し、前記移送モジュールの第1のポートと1つ以上のチャンバの種々のポートを整列させることをさらに含む、請求項52に記載の方法。
- 1つ以上の圧力差を介して、1つ以上の液体を前記1つ以上のチャンバから前記中心チャンバ内に引き込むことをさらに含む、請求項60に記載の方法。
- 前記移送モジュールを側方に平行移動させることを繰り返し、前記移送モジュールの第2のポートと1つ以上のチャンバの種々のポートを整列させることをさらに含む、請求項52に記載の方法。
- 1つ以上の圧力差を介して、1つ以上の液体を前記1つ以上のチャンバから前記中心チャンバ内に引き込むことをさらに含む、請求項62に記載の方法。
- 1つ以上の圧力差を介して、1つ以上の液体を前記中心チャンバから前記1つ以上のチャンバ内に引き込むことをさらに含む、請求項62に記載の方法。
- 前記第2のチャンバ内に前記試料を処理することと、
第3の圧力差を介して、前記試料を前記第2のチャンバから前記中心チャンバ内に引き込むことと、
前記移送モジュールを側方に平行移動させ、前記移送モジュールの第2のポートを第3のチャンバのポートに整列させることと、
第4の圧力差を介して、前記試料を前記中心チャンバから前記第3のチャンバ内に引き込むことと、
前記第3のチャンバ内に前記試料を処理することと、
前記移送モジュールを側方に平行移動させ、前記移送モジュールの第2のポートを第4のチャンバのポートに整列させることと、
第5の圧力差を介して、前記試料を前記中心チャンバから前記第4のチャンバ内に引き込むことと、
前記第4のチャンバ内にある間、前記試料の1つ以上の品質を測定することと
をさらに含む、請求項52に記載の方法。 - 前記試料を前記第2のチャンバ内に引き込むことは、フィルタを通して、前記試料を流動させることを含む、請求項52に記載の方法。
- 前記試料を前記第2のチャンバ内に引き込むことは、流体スプリッタを通して、前記試料を1つ以上のサブチャンバ内に流動させることを含む、請求項52に記載の方法。
- 前記中心チャンバ内において前記試料を磁気撹拌棒で混合することをさらに含む、請求項52に記載の方法。
- 方法であって、前記方法は、
筐体内で移送モジュールを側方に平行移動させ、前記移送モジュールの外側表面上の構造を第1のチャンバと関連付けられた第1のポートおよび第2のチャンバと関連付けられた第2のポートと整列させることと、
少なくとも、前記第1のポートおよび前記第2のポートを覆って整列された前記構造を介して、試料を前記第1のチャンバから前記第2のチャンバに引き込むことと、
前記移送モジュールの壁を通したポートを介して、前記試料を前記第2のチャンバから前記移送モジュール内に位置する第3のチャンバに引き込むことと
を含む、方法。
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