JP6833703B2 - 卒中サブタイプの判定装置および方法 - Google Patents
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Description
本特許出願は、2014年11月14日に出願された米国特許仮出願第62/079,631号の優先権主張出願であり、この米国特許仮出願を参照により引用し、その開示内容を本明細書の一部とする。
全血試験用試料を受け入れ、試験用試料を刺激して凝血塊への試験用試料の変換を応じさせ、そして変換中、試験用試料の物理的特性を測定するよう構成された器具を含み、物理的性質は、データによって表され、
器具は、全血試験用試料の第1の変換を生じさせて物理的性質が虚血性または出血性指標を提供するようにし、器具は、全血試験用試料の第2の変換を生じさせて物理的特性が試料影響指標を提供するようにすることを特徴とするシステムが提供される。
流体処理構造を含む試料前処理部分と、
試料保持構造を含む試料試験部分とを有し、試料試験部分は、流体処理部分と試料保持構造とを流体連通させる流体通路を経て試料前処理部分に結合され、
試料保持構造は、試験されるべき試料を支持して試料をカートリッジに加えられた励振に応答して共振状態に励振させることができるようにし、試料保持構造は、試料の共振の観察を可能にし、
試料試験部分は、試料の虚血性または出血性指標を提供するための第1の試験部分および治療影響指標を提供するための第2の試験部分を含むことを特徴とするカートリッジが提供される。
被検者から全血試料を得るステップと、
励振によって全血試料の第1および第2の部分を凝血塊に変換するステップと、
全血試料の第1および第2の部分を変換中に測定して変換中に試験用試料の物理的特性を表すデータを得るステップと、
第1の部分のデータから虚血性または出血性指標を求めるとともに第2の部分のデータから治療影響を判定するステップと、
指標に基づいて卒中サブタイプを分類するステップとを含むことを特徴とする方法が提供される。
1.卒中指標を一次予防で用いると、個々の患者ベースで修正可能なリスクマーカを管理することができる。
2.EMS職員を訓練して最初の応答時にかつ/あるいは搬送中、血栓弾性記録的アッセイを実行することができ、その結果、情報を行き先病院のEDスタッフおよび他の発作チームメンバーに中継することができる。ついには、EMSスタッフにTPAまたは凝血塊促進薬をある特定の患者に投与させることさえも可能な場合があり、これは、特に大型大都市医療センターの外部にありかつ田舎の十分にサービスを受けられない場所でそうであるように長距離搬送において重要である。
3.病院またはポイント・オブ・ケアセッティングでは、TPAがいったん投与されると、血液試料を用いて、達成された溶解度を判定することができ、必要ならば追加の量を投与する。溶解は、現行の実務の場合のように体重では判定されず、したがって、体重に基づいた溶解薬を投与することは、最適ではない。各患者の止血状態は、投薬を良好に案内することができ、したがって、患者は、過剰治療されることはなくまたは治療不足になることがない。TPAの過剰投薬は、事実、出血性コンバージョンの決定因子のうちの1つとなりうる。
4.再発発作の二次的予防のための長期間治療を決定する際、血栓弾性記録試験の結果を用いることは、薬剤および服用量の適正な選択を案内することができ、それにより過剰治療または治療不足のリスクを減少させる。これは、新たなかつより有力な薬剤が利用可能になっているので特に重要である。
Claims (3)
- 卒中サブタイプが急性虚血性発作と出血性発作のいずれであるかを判定するシステムであって、前記システムは、血栓弾性記録図による全血の変換により止血を測定することができる適当に構成された装置である変換装置を含み、
前記変換装置は、全血試験用試料を受け入れ、前記試験用試料を刺激して凝血塊への前記試験用試料の変換を生じさせ、そして前記変換中、凝血塊の粘弾性特性を求めるために外部励振に応答して前記試験用試料の共振振動数の一連の非接触試験を実施することにより前記試験用試料の物理的特性を測定するよう構成され、
前記物理的特性は、初期凝血塊生成から最終の凝血塊溶解までの止血プロセスの全体像をもたらすデータによって表され、
前記変換装置は、第1の全血試験用試料の前記変換を生じさせて前記物理的特性が虚血性または出血性指標を提供するようにし、
前記変換装置は、前記第1の全血試験用試料の前記変換と同時に第2の全血試験用試料の前記変換を生じさせて前記物理的特性が治療影響指標を提供するようにする、システム。 - 前記変換装置は、第1のチャネルおよび第2のチャネルを備えたカートリッジを有し、前記第1および第2のチャネルは、それぞれ、前記第1および前記第2の変換に対応している、請求項1記載のシステム。
- 卒中サブタイプが急性虚血性発作と出血性発作のいずれであるかを判定する方法であって、
血栓弾性記録図による全血の変換により止血を測定することができる適当に構成された装置である変換装置を用意するステップを含み、
被検者から全血試料を得るステップと、
前記試験用試料を刺激して凝血塊への前記試験用試料の変換を生じさせるステップと、
前記変換中、凝血塊の粘弾性特性を求めるために外部励振に応答して前記試験用試料の共振振動数の一連の非接触試験を実施することにより前記試験用試料の物理的特性を測定するステップであって、前記物理的特性は、初期凝血塊生成から最終の凝血塊溶解までの止血プロセスの全体像をもたらすデータによって表されるステップと、
第1の全血試験用試料の前記変換を生じさせて前記物理的特性が虚血性または出血性指標を提供するステップと、
前記第1の全血試験用試料の前記変換と同時に第2の全血試験用試料の前記変換を生じさせて前記物理的特性が治療影響指標を提供するステップと、を含む方法。
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PCT/US2015/060499 WO2016077657A1 (en) | 2014-11-14 | 2015-11-13 | Apparatus and method to determine stroke subtype |
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US5447440A (en) * | 1993-10-28 | 1995-09-05 | I-Stat Corporation | Apparatus for assaying viscosity changes in fluid samples and method of conducting same |
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-
2015
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- 2015-11-13 JP JP2017544844A patent/JP6833703B2/ja active Active
- 2015-11-13 EP EP15805345.4A patent/EP3218723B1/en active Active
- 2015-11-13 WO PCT/US2015/060499 patent/WO2016077657A1/en active Application Filing
- 2015-11-13 CN CN201580073453.XA patent/CN107438765B/zh active Active
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JP2021001892A (ja) | 2021-01-07 |
EP3218723A1 (en) | 2017-09-20 |
JP7092831B2 (ja) | 2022-06-28 |
JP2017534069A (ja) | 2017-11-16 |
EP3218723B1 (en) | 2021-10-06 |
CN107438765B (zh) | 2022-07-26 |
WO2016077657A1 (en) | 2016-05-19 |
US20180238913A1 (en) | 2018-08-23 |
CN107438765A (zh) | 2017-12-05 |
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