JP6770107B2 - システム - Google Patents
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Description
検査される血液試料を受け取るように構成された血液試料受け器と、
一つ以上の血液の処理および検査のための複数の経路であって、前記血液の処理および検査のための複数の経路のそれぞれが前記血液試料の一部を受け取り、かつ、
前記血液試料受け器と流体連通する血液試料体積測定室であって、前記血液試料体積測定室は、前記血液試料容器から所定体積の前記血液試料を含むための選択された内部体積を有する血液試料体積測定室と、
前記血液試料体積測定室およびその中の試薬に流体連通する混合室であって、前記血液試料体積測定室から血液試料を受け取るように、かつ、受け取られた前記血液と前記試薬とを混合するように構成された混合室と、
混合された血液および試薬が前記検査室に残っている間に、前記混合された血液および試薬に実行される粘弾性検査のために前記混合室から前記混合された血液および試薬を受け取るように構成された粘弾性血液検査室と、を備える一つ以上の血液の処理および検査のための経路と、
を備えるカートリッジ。
血液試料受け器と、
前記血液試料受け器と選択的に流体連通する複数の血液試料経路であって、前記血液試料経路のそれぞれが、
前記血液試料受け器を介して所定量の血液試料を受け取るための血液測定室と、
前記所定量の前記血液試料を一つ以上の試薬と一緒に受け取り、かつ、混合するための試薬混合室と、
前記試薬混合室から前記血液試料の少なくとも一部を、そこで混合される一つ以上の試薬と一緒に受け取るための血液凝固血液検査室であって、その中に、血液凝固特性を測定するための可動プローブを有する血液凝固血液検査室と、を備える複数の血液試料経路と、
を備えるカートリッジ装置
血液試料受け器と、
前記血液試料受け器と選択的に流体連通する少なくとも一つの血液試料経路であって、前記血液試料経路は、
前記血液試料受け器を介して所定量の血液試料で満たされるように構成された血液測定室と、
前記血液測定室から前記所定量の前記血液試料を受け取り、かつ、前記所定量の前記血液試料を一つ以上の試薬と一緒に混合する試薬混合室と、
前記試薬混合室から、前記血液試料の少なくとも一部を、それと一緒に混合される一つ以上の試薬と一緒に受け取る血液凝固血液検査室であって、その中に、血液凝固特性を測定するための可動プローブを有する血液凝固血液検査室と、
前記血液測定室からの前記所定量の前記血液試料を越えた過剰な血液を収集するために、前記血液試料経路と流体連通するオーバーフロー室と、を備える少なくとも一つの血液試料経路と、
を備えるカートリッジ装置。
粘弾性測定部品を収納する制御ユニットであって、外部ポートを画定する制御ユニットと、
少なくとも一つの使い捨てカートリッジであって、前記カートリッジの外面に沿ってアクセス可能な血液試料入口と、前記カートリッジの内面に沿って配置された複数の血液検査室とを備える少なくとも一つの使い捨てカートリッジと、を備え、
前記複数の血液検査室が前記制御ユニット内に配置される一方で、前記カートリッジの前記血液試料入口が、前記制御ユニットの外部に残るように、前記制御ユニットは、前記外部ポートに挿入された場合、前記使い捨てカートリッジと取り外し可能に嵌合するように構成されている、測定システム。
血液試料入口が外部に露出したままとなるように血液検査制御コンソール内に使い捨てカートリッジを挿入することと、
前記血液試料入口に血液試料リザーバを取り付けることと、
前記複数の血液検査室のそれぞれにおいて血液の粘弾性特性を測定するために、前記カートリッジ内の前記複数の血液検査室への前記血液試料リザーバ内の血液の自動輸送を開始するように、前記血液検査制御コンソールのユーザインターフェースを介してユーザ入力を提供することと、を含む方法。
血液試料リザーバ容器と取り外し可能に嵌合するように構成された空洞を画定する血液試料受け器構造と、
複数の血液検査室であって、前記血液試料受け器構造から離れて配置され、かつ、前記血液検査室のそれぞれが、その中に、血液凝固特性を測定する可動プローブを有し、前記血液検査室のすべてが、前記血液試料受け器構造と選択的に流体連通している、複数の血液検査室と、
を備えるカートリッジ装置。
血液凝固特性を測定するための複数の血液検査室であって、前記血液検査室のそれぞれは、大気に露出され、かつ、前記血液検査室の側壁に沿って配置された血液入口ポートを有し、
前記血液検査室のそれぞれは、前記血液検査室の前記血液入口ポートよりも低い高さで、前記カートリッジ装置において画定された前記試薬混合室のそれぞれの出口ポートと流体連通している、カートリッジ装置。
所定量の血液試料を一つ以上の試薬ビーズと一緒に受け取りかつ混合するための複数の試薬混合室と、
前記混合室内で前記試薬混合ビーズのそれぞれの所定鉛直位置を維持するように、前記試薬混合室内に延びる複数の保持要素であって、前記試薬混合室の少なくとも一つの前記保持要素が、前記複数の試薬混合ビーズを互いから離間した状態に維持するように前記複数の試薬混合ビーズと係合する、複数の保持要素と、
を備えるカートリッジ装置。
所定量の血液試料を一つ以上の試薬ビーズと一緒に受け取りかつ混合するための複数の試薬混合室と、
前記試薬混合室に保持された可動混合要素であって、前記血液試料に対して不活性な材料を備える可動混合要素と、
前記可動混合要素から離間した位置に試薬混合ビーズを維持するために、前記試薬混合室内に延びる複数の保持要素と、
を備えるカートリッジ装置。
血液検査制御ユニットの受け部に挿入された血液検査カートリッジを検出することと、
一つ以上の血液検査室のそれぞれにおける血液の粘弾性特性を測定するために、前記カートリッジ内の前記一つ以上の血液検査室に前記血液試料リザーバ内の前記血液の自動輸送を開始させるように、前記血液検査制御ユニットのユーザインターフェースを介して入力をユーザに促すことと、
前記血液検査カートリッジの血液試料受け器から所定量の血液試料を、前記カートリッジ内の前記一つ以上の血液検査室のそれぞれに自動的に輸送することと、
前記カートリッジの前記血液検査室のそれぞれで、血液凝固特性を測定するプローブを移動させることと、
前記血液凝固特性の測定結果を、前記ユーザインターフェースを介して表示させることと、
を含む方法。
その中に複数の血液検査室を有する使い捨てカートリッジを取り外し可能に受け取るように構成された少なくとも一つの結合要素と、前記使い捨てカートリッジの前記複数の血液検査室内の前記血液試料の凝固特性を測定するように構成された複数の測定部品と、を収納する制御ユニットハウジングと、
前記結合要素の近くに配置され、前記カートリッジを加熱するように構成された、一つ以上の加熱要素と、
前記結合要素の近くに配置された一つ以上の温度センサであって、前記温度センサが、前記使い捨てカートリッジの前記複数の血液検査室が所定温度に到達したことを示した後に、前記使い捨てカートリッジの前記複数の血液検査室に血液を輸送するように、前記制御ユニットが構成されている、一つ以上の温度センサと、
を備える制御コンソール。
Claims (19)
- 血液試料の特性を測定するためのシステムであって、
粘弾性測定部品を収納する制御ユニットであって、外部ポートを画定する制御ユニットと、
使い捨てカートリッジであって、血液試料受け器と流体連通する血液試料体積測定室であって、それぞれが所定体積の前記血液試料を含むための選択された内部体積を有する複数の前記血液試料体積測定室を含む使い捨てカートリッジと、を備え、
前記血液試料体積測定室は、直列に配置されており、その結果、第一の血液試料体積測定室が、所定レベルまで血液試料で満たされるように構成され、かつ、その後、連続する前記血液試料体積測定室のそれぞれが、順次満たされるように構成されており、
前記制御ユニットは、前記外部ポート内に挿入されたときに前記使い捨てカートリッジと取り外し可能に嵌合するように構成され、前記カートリッジの前記血液試料受け器が前記制御ユニットの外に残るようになっている、システム。 - 前記カートリッジの内面に沿って配置された複数の血液検査室を更に備え、前記血液検査室のそれぞれは、前記カートリッジが外部ポートに挿入された際、前記制御ユニット内に配置される、請求項1に記載のシステム。
- 前記使い捨てカートリッジは、血液試料リザーバ容器と取り外し可能に嵌合するように構成され、
前記使い捨てカートリッジは、血液凝固特性を測定するための可動プローブを有する複数の血液検査室をさらに備え、
前記血液検査室のすべては、前記血液試料受け器と選択的に流体連通する、請求項1に記載のシステム。 - 前記使い捨てカートリッジの前記血液検査室のそれぞれは、大気に露出され、かつ、前記血液検査室に沿って配置された血液入口ポートを備え、
各血液検査室の前記血液入口ポートは、前記使い捨てカートリッジのそれぞれの試薬混合室の対応する出口ポートと流体連通している、請求項3に記載のシステム。 - 前記使い捨てカートリッジは、所定量の血液試料を一つ以上の試薬ビーズと一緒に受け取りかつ混合するように構成された複数の試薬混合室を備え、
前記試薬混合室のそれぞれは、前記試薬混合室内で試料混合ビーズのそれぞれの所定鉛直位置を維持するように、前記試薬混合室内に延びる複数の保持要素を備え、
前記保持要素は、前記試料混合ビーズを互いに離間した状態に維持するように、前記試料混合ビーズと係合する、請求項1に記載のシステム。 - 前記試薬混合室のそれぞれは、可動混合要素を備え、
前記可動混合要素は、前記血液試料を吸収しない材料を備え、
前記可動混合要素から離れた位置に前記試料混合ビーズを維持するために、前記複数の保持要素のそれぞれが、対応する前記試薬混合室内に延びている、請求項5に記載のシステム。 - 前記使い捨てカートリッジは、前記血液試料受け器と選択的に流体連通する複数の血液試料経路を画定し、
前記血液試料経路は、互いに並列に接続され、
前記血液試料経路のそれぞれは、前記血液試料受け器を介して所定量の血液試料を受け取るように構成された前記血液試料体積測定室と、前記所定量の前記血液試料を一つ以上の試薬と一緒に受け取りかつ混合するように構成された試薬混合室と、前記試薬混合室から、前記血液試料の少なくとも一部と、それと一緒に混合された一つ以上の試薬とを一緒に受け取るように構成された血液検査室と、を備え、
前記血液検査室は、その中に、血液凝固特性を測定するための可動プローブを備える、請求項1に記載のシステム。 - 前記血液試料経路の前記血液試料体積測定室は、直列に配置されており、その結果、複数の前記血液試料経路の第一の経路の血液試料体積測定室が、所定レベルまで血液試料で満たされるように構成され、複数の前記血液試料経路の第二の血液試料体積測定室が、第一の血液試料体積測定室から溢れた血液試料で満たされるように構成され、その後、連続する血液試料体積測定室のそれぞれが、前の血液試料体積測定室から溢れた血液試料で順次満たされるように構成されている、請求項7に記載のシステム。
- 前記直列の血液試料体積測定室における前記血液試料受け器と反対端に真空ポートをさらに備え、
外部真空が前記真空ポートに適用された場合、血液が、前記血液試料体積測定室のそれぞれを順次満たすように前記血液試料入口から輸送されるように、前記カートリッジが構成されている、請求項8に記載のシステム。 - 前記血液試料受け器と、前記血液試料経路のうちの第一の経路の前記血液試料体積測定室との間で血液を輸送するための第一経路をさらに備える、請求項9に記載のシステム。
- 前記第一経路内に配置された第一バルブをさらに備え、
前記血液試料体積測定室のそれぞれを順次満たすために、血液試料が前記血液試料受け器から前記第一経路を通って輸送されることを可能にするように、前記第一バルブが、選択的に開かれるように構成されている、請求項10に記載のシステム。 - 前記血液試料経路のそれぞれは、前記血液試料体積測定室と、対応する前記試薬混合室との間で血液を輸送するための第二経路を備える、請求項7に記載のシステム。
- 前記血液試料経路のそれぞれは、前記カートリッジの周囲の外部への第一通気孔を備え、
前記第一通気孔が閉位置にある場合、血液が、前記血液試料体積測定室から前記試薬混合室に前記第二経路を通って流れないように、前記第一通気孔のそれぞれが配置されている、請求項12に記載のシステム。 - 前記第一通気孔が、選択的に開かれるように構成され、かつ、前記第一通気孔が開位置にある場合、血液が、前記血液試料体積測定室から前記試薬混合室に流れるように、前記カートリッジが構成されている、請求項13に記載のシステム。
- 前記試薬混合室は、前記血液試料体積測定室からの前記血液と接触したときに溶解して混合された血液および試薬を前記試薬混合室内に提供する固体状の試薬ビーズを備え、
前記試薬ビーズは、CaCl2、エラグ酸/リン脂質、組織因子、ヘパリナーゼ、ポリブレン、サイトカラシンD、トラネキサム酸の一つ以上を含む試薬組成物を備える、請求項7に記載のシステム。 - 前記血液試料経路のそれぞれが、前記試薬混合室から、対応する前記血液検査室に混合された血液および試薬を輸送するための第三経路を備える、請求項7に記載のシステム。
- 前記血液試料経路のそれぞれが、前記第三経路内に配置された第二バルブを備え、
前記第二バルブのそれぞれは、閉位置にある場合に、前記第三経路を介する前記混合された血液および試薬の流れを妨げるように、かつ、開位置にある場合、前記第三経路を介する前記混合された血液および試薬の流れを可能にするように構成されている、請求項16に記載のシステム。 - 加圧ポートであって、外部圧力が前記加圧ポートに加えられ、かつ、前記第二バルブが開位置にある場合、前記試薬混合室からの前記混合された血液および試薬が、前記試薬混合室から、対応する血液検査室へ前記第三経路を介して輸送されるように、配置された加圧ポートをさらに備える、請求項17に記載のシステム。
- 前記血液検査室は、その中に、血液凝固特性を機械的に検査する可動プローブ要素を備える、請求項7に記載のシステム。
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US20160091483A1 (en) | 2016-03-31 |
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