JP2019503737A - 眼センサ、システム、及び方法 - Google Patents
眼センサ、システム、及び方法 Download PDFInfo
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Abstract
Description
発明の分野
本発明は、監視者(例えば、麻酔医、集中治療医、または臨床医)に、患者の鎮静、意識、及び応答性のレベルを含む患者の脳幹活動または改変された脳幹状態の指標を提供するために、患者の眼球(例えば、角膜/強膜)の1つ以上の固視微動のグラフ及び数値表現を表示する、眼センサ、システム、及び方法に関する。これは、例えば、手術中に患者が麻酔される場合のような、医療または臨床的処置の前、間、及び後に使用され得る。眼センサのセンサは薄く柔軟であり、患者の閉じられた眼瞼の形状に一致することができるか、または、患者の眼球の固視運動に応答する患者の開いた眼瞼の組織ひだ内に位置付けられることができる。
刺激に対する応答をもたらす身体及び脳活動における一時的な増加対鎮静または麻酔のレベルにおける基本的な転換と、
睡眠状態の活動抑制対薬物誘発性の活動抑制と、
意識のある認識対薬によって麻痺され、通常の身体活動指標が不在である場合の意識のない認識の欠如と、
軽対中レベルの鎮静またはしばしば同様に存在する他の微細なグレードと、
「非応答性」のグラデーションまたは身体的に観察可能なカットオフポイント未満に存在する脳状態活動の連続とを区別するための有効な客観的データを提供する。これらの状態は、OMT周波数測定値単独によって明確に区別されない。OMT周波数はこれらの状態を示すことができるが、多くの場合、データの単独セットの大半の場合のように、同様のOMT周波数読み取り値が複数の状態で存在する。同様に、マイクロサッカード動作、反応性パターン、及び突発波は、応答の強度及び速度の優れた指標である一方で、一般的な傾向及び漸進的変化を評価する際に価値が少ない。脳幹に対する既知の同様の基本薬物用量及び効果の時間の所与の長さの間、複数の刺激に関連する一般的な強いマイクロサッカードイベントの期間及び即座に隣接する反対の期間を観察し得る。追加の情報がない場合、マイクロサッカード反応性の観察者は、間違った結論を導き得て、致死性薬物の不適当な投与をもたらす可能性がある。
例示の簡略化及び明確化のために、適切な場合、参照番号及び/または名称が、対応するまたは類似の要素を示すために、異なる図面間で繰り返されていることが理解されるであろう。加えて、本明細書に記載の実施形態の完全な理解を提供するために、多数の具体的な詳細が記載されている。しかしながら、本明細書に記載される実施形態は、これらの具体的な詳細なしで実施され得ることが当業者に理解されるであろう。他の事例において、記載されている関連する関連特徴を不明瞭にしないように、方法、手順、及び構成要素は詳細に記載されていない。図面は必ずしも縮尺通りではなく、特定の部分の割合は、詳細及び特徴をより良好に説明するために誇張されている場合がある。説明は、本明細書に記載の実施形態の範囲を制限すると考えられるものではない。本開示において「一」または「1つの」実施形態への言及は、必ずしも同じ実施形態に対するものではなく、そのような言及は少なくとも1つを意味することに留意されたい。
図面のうちの図18は、信号プロセッサ9−1と通信しているセンサ16の実施形態を示し、この信号プロセッサ9−1は、増幅されたアナログ固視運動生体信号を増幅器3−1から、無線通信経路を介して受信することができる。増幅器3−1が無線通信経路を介して信号プロセッサ9−1と通信する実施形態では、前述のa/d変換器110は、プロセッサ9(図17)から除去され、増幅器3−1に位置して、リボン5から固視運動生体信号を受信する。図18の増幅器3−1のA/D変換器110は、電池、マイクロセル、または好適な電源、及びアンテナと共に同じく増幅器3−1に位置する無線送信器116に電気的に結合されている。この場合、遮蔽ケーブル(図7及び17では7と標記される)は、排除されている。同様に、図18の信号プロセッサ9−1には、増幅器3−1の無線送信器116と互換性であり、それと通信可能なトランシーバ118が設けられている。したがって、信号プロセッサ9−1は、眼センサ1から遠隔に位置してもよく(例えば、看護師ステーションに)、これにより、患者は、手術または他の処置から回復し、意識を取り戻す過程で監視され得る。
Claims (21)
- センサからの出力信号を受信する工程であって、前記センサが眼球運動に応じて前記出力信号を生成する、工程と、
周波数成分及び振幅成分を生成する工程であって、前記周波数成分が眼球マイクロトレモア(OMT)周波数を含み、前記振幅成分がマイクロサッカード(MS)振幅を含み、前記出力信号から前記OMT周波数及び前記MS振幅が得られる、工程と、
前記周波数成分及び前記振幅成分から、組み合わされたデータセットを生成する工程であって、前記組み合わされたデータセットが、前記周波数成分、前記振幅成分、及び前記周波数成分と前記振幅成分との間の時間関係を含む、工程と
を含む、方法。 - 前記振幅成分が、OMT振幅をさらに含み、前記OMT振幅が、前記出力信号から得られる、請求項1に記載の方法。
- 前記組み合わされたデータセットを、少なくとも1つの既知の参照値と比較して、比較を得る工程をさらに含む、請求項1に記載の方法。
- 参照値を生成する工程をさらに含み、前記参照値が、前記組み合わされたデータセット、前記比較、または前記組み合わされたデータセットと前記比較との組み合わせに基づく、請求項3に記載の方法。
- 前記センサが、眼瞼を通して眼球運動を感知する、請求項1に記載の方法。
- 出力信号を生成する工程をさらに含み、
前記出力信号を生成する工程が、
圧電素子によって、眼球運動に応じて電圧を生成すること、及び
電気接続部に沿って電流を伝達すること
を含む、請求項1に記載の方法。 - 前記出力信号を増幅して、増幅された出力信号をレンダリングする工程
をさらに含み、
前記周波数成分及び前記振幅成分を生成する工程が、前記増幅された出力信号を処理することを含む、請求項1に記載の方法。 - 前記周波数成分及び前記振幅成分を生成する工程が、プロセッサによって前記出力信号を処理することを含み、
前記出力信号を処理することが、
OMT及びMSに起因する眼球運動を分離すること、
OMT周波数を判定すること、及び
組み合わされたOMT MS振幅、MS電力、MS反応性、またはそれらの組み合わせを判定すること
を含む、請求項1に記載の方法。 - 結果を表示する工程をさらに含み、
前記結果を表示する工程が、
前記周波数成分及び前記振幅成分の表現、前記組み合わされたデータセット、MS振幅の反応性、またはそれらの組み合わせを提示すること
を含む、請求項1に記載の方法。 - 前記周波数成分、前記振幅成分、前記組み合わされたデータセット、またはそれらの組み合わせを、既知の値、既知のパターン、または既知の値と既知のパターンの両方と比較する工程をさらに含む、請求項1に記載の方法。
- 前記比較する工程に基づいて、警告または提案される措置を表示する工程をさらに含む、請求項10に記載の方法。
- イベント検出及びイベント評価をさらに含み、イベント評価が、イベントの反応性、長期比率及び短期比率、イベント前、イベント中、及びイベント後の比較分析、振動数、またはそれらの組み合わせを判定することを含む、請求項1に記載の方法。
- センサからの出力信号を受信する工程であって、前記センサが眼球運動に応じて前記出力信号を生成する、工程と、
眼球マイクロトレモア(OMT)成分及びマイクロサッカード(MS)成分を含むパラメータを導出する工程であって、前記出力信号から前記OMT成分及び前記パラメータが得られる、工程と、
前記OMT成分及び前記パラメータから、組み合わされたデータセットを生成する工程であって、前記OMT成分が、OMT周波数、OMT振幅、OMT速度、またはそれらの組み合わせから導出され、前記パラメータが、MS周波数、MS振幅、MS速度、またはそれらの組み合わせから導出され、前記組み合わされたデータセットが、前記OMT成分、前記パラメータ、及び前記OMT成分と前記パラメータとの間の時間関係を組み込む、工程と
を含む、方法。 - 前記OMT成分が、OMT周波数から導出される、請求項13に記載の方法。
- 前記組み合わされたデータセットを、少なくとも1つの既知の参照値と比較して、比較を得る工程をさらに含む、請求項13に記載の方法。
- 参照値を生成する工程をさらに含み、前記参照値が、前記組み合わされたデータセット、前記比較、またはそれらの組み合わせに基づく、請求項15に記載の方法。
- 前記センサが、眼瞼を通して眼球運動を感知する、請求項13に記載の方法。
- 出力信号を生成する工程をさらに含み、
前記出力信号を生成する工程が、
圧電素子によって、眼球運動に応じて電圧を生成すること、及び
電気接続部に沿って電流を伝達すること
を含む、請求項13に記載の方法。 - 前記出力信号を増幅して、増幅された出力信号をレンダリングする工程
をさらに含み、
前記OMT成分及び前記パラメータを導出する工程が、前記増幅された出力信号を処理することを含む、請求項13に記載の方法。 - 前記OMT成分及び前記パラメータを導出する工程が、プロセッサによって前記出力信号を処理することを含み、
前記出力信号を処理することが、
前記OMTのOMT周波数に起因する眼球運動を分離すること
を含む、請求項13に記載の方法。 - 結果を表示する工程をさらに含み、
前記結果を表示する工程が、
前記OMT成分の表現、前記パラメータ、前記組み合わされたデータセット、反応性、またはそれらの組み合わせを提示すること
を含む、請求項13に記載の方法。
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