JP2015512658A5 - 組織内の周波数に対する表面下抵抗率の相対的空間変化を決定するためのシステム - Google Patents
組織内の周波数に対する表面下抵抗率の相対的空間変化を決定するためのシステム Download PDFInfo
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Description
組織の湿潤度の他覚的尺度を提供することができるデバイス及び方法が開示される。一部の具体的なバリエーションでは、システム、デバイス及び方法は、被検体内部及び/又は被検体外部の設定(家庭での使用を含む)において肺鬱血(例えば、血管外間質液)を測定するように構成され得る。例えば、本願で開示されるシステムは、肺鬱血に対する非侵襲性で正確で再現可能な測定を提供し得る。こうしたシステムは、肺液評価モニタと称され得る。本願に記載されるあらゆるシステムは、皮膚に適用される電極の特定の幾何学的パターンにおいて電流を印加して電圧を測定することから導出される皮膚から組織までの見掛け抵抗率の相対的なパーセントの差を用いて組織の湿潤度を検出する実行可能ロジックを含み得る。従って、本願に記載されるシステムは、非侵襲性で高速であり、電離放射線を用いない。
任意の適切な導電性材料を用いて、電極を形成することができ、銀/塩化銀が挙げられる。一部バリエーションでは、センサは、電極上に導電性ゲルを含む(又は、導電性ゲルと相性がよい)。一部バリエーションでは、導電性ゲルは接着剤を含み得る。例えば、一部バリエーションでは、ゲルがセンサを被検体に接着させる。
配置のロバスト性を試験するため(kの誤差に対する“ウィグル”試験)、一番目がm1≒0.507で、二番目がm2≒6.736の二つのダイポール・ダイポール型アレイについて上記で計算した調査深度について考える。簡単のため、電流駆動電極は静止していて、聴診電極が互いに±1/2の電極間隔だけ移動する場合(つまり、一番目がC1=16、C2=18、P1=19±1/2、P2=21±1/2であり、二番目についても同様である)を考える。結果としてのDOI変化は、Δm1≒[0.305,0.677]、Δm2≒[6.611,6.862]であり、相対的変化は、Δm1/m1≒73%、Δm2/m2≒4%である。この結果は、一番目のダイポール・ダイポール型アレイのDOIが1/2電極偏差の影響を受け易いことを示している。
上記例では、電気抵抗率アレイを、調査深度と、電極位置の小さな変化に対するロバスト性とに基づいて選択していた。しかしながら、調査深度が大きくなるにつれて、P1とP2との間で測定される電圧降下が小さくなり、電気抵抗率アレイを選択する前に、結果としての電圧降下を正確に測定できることを識別する必要がある。従って、信号対ノイズ比(signal to noise ratio,SNR)閾値を追加的に用い得る。SNR閾値は、使用する又は使用しない電気抵抗率アレイを識別するための選択基準としても用いられ得る。このSNR閾値は、P1及びP2間の電圧降下の大きさについて二つの数学的モデルを検討することによって、求められ得る。第一のモデルは、点電流源に基づいていて、第二のモデルは、線電荷モデルに基づいていて、両方について、電流が、一様な半空間に流されるものとする。電圧の値φは、抵抗率ρの一様な半空間において、大きさIの点源からの距離rにおいて、以下のように減衰する(非特許文献2、p.33−34)。
φ=Iρ/(2πr)
四極アレイについて、P1での電圧は、C1の距離rC1P1での電流受けと、C2の距離rC2P1での電流源との両方の寄与を有する。IC1=−IC2と仮定すると、P1での電圧が以下のようになる:
φ=Iρ/(2πr)
四極アレイについて、P1での電圧は、C1の距離rC1P1での電流受けと、C2の距離rC2P1での電流源との両方の寄与を有する。IC1=−IC2と仮定すると、P1での電圧が以下のようになる:
上記と同じ二つのダイポール・ダイポール型アレイ(つまり、C1=16、C2=18、P1=19、P2=21と、C1=2、C2=4、P1=29、P2=31)を用い、四極抵抗率測定を点電極で行うと仮定すると、電圧降下の大きさは4I1ρ/(15επ)≒0.928及び4I2ρ/(19575επ)≒0.7mVとなる(10mAの電流、10Ωmの抵抗率、0.0091mの電極間隔とする)。従って、電圧降下は、二番目のダイポール・ダイポール型アレイについて略1/1300になり、閾値を用いて、電圧信号が、システムによって十分正確に測定されるだけ大きいことを保証しなければならない。しかしながら、その閾値を求める前に、ΔφP1P2をもたらす点電極モデルを、楕円電極に拡張して、互いに相対的に近い電気抵抗率アレイに対する電極の幾何学的形状の影響を予測する。
本願明細書及び特許請求の範囲に記載されている数値及び/又は位置は、その値及び/又は位置の予測される妥当な範囲内にある。例えば、或る数値は、記載されている値(又は数値範囲)の±0.1%の値、記載されている値(又は数値範囲)の±1%の値、記載されている値(又は数値範囲)の±2%の値、記載されている値(又は数値範囲)の±5%の値、記載されている値(又は数値範囲)の±10%の値等である。本願に記載される数値範囲は、そこの含まれる全ての部分的範囲を含むものである。
Claims (17)
- 被検体の組織の水和度を決定するためのシステムであって、
センサ上の電流注入電極対の間における複数の異なる周波数での電流の印加を制御すると共に、前記センサ上の電圧検出電極対から結果としての電圧情報を受信するように構成されたコントローラと、
前記コントローラと通信する処理ユニットであって、印加された電流及び結果としての電圧の大きさと周波数と位相とのうち一つ以上に基づいて、周波数に対する表面下抵抗率の相対的空間変化を決定するように構成された処理ユニットであって、前記周波数に対する表面下抵抗率の相対的空間変化が、前記センサの下の領域の表面下抵抗率の相対的変化の空間分布を含み、前記表面下抵抗率の相対的変化が、調べられる異なる周波数に対して相対的である、処理ユニットと、
前記表面下抵抗率の相対的変化の空間分布から或るボリュームの被検体の組織についての含水量の表現を出力するための出力部と、を備えたシステム。 - 複数の電流注入電極対及び複数の電圧検出電極対を備えたセンサを更に備え、前記コントローラが、前記電流注入電極対の間における複数の異なる周波数での電流の印加を制御する、請求項1に記載のシステム。
- 複数の電流注入電極対及び複数の電圧検出電極対を備えたセンサを更に備え、前記複数の電流注入電極対及び前記複数の電圧検出電極対が直線状に配置されていて、前記コントローラが、前記電流注入電極対の間における複数の異なる周波数での電流の印加を制御する、請求項1に記載のシステム。
- 複数の電流注入電極対及び複数の電圧検出電極対を有する接着性パッチセンサを更に備え、前記コントローラが、前記電流注入電極対の間における複数の異なる周波数での電流の印加を制御する、請求項1に記載のシステム。
- 前記コントローラが、100kHzよりも低い低周波数及び100kHzよりも高い高周波数での前記電流注入電極対の間における電流の印加を制御するように構成されている、請求項1に記載のシステム。
- 前記コントローラが、50kHz以下の低周波数及び200kHz以上の高周波数での前記電流注入電極対の間における電流の印加を制御するように構成されている、請求項1に記載のシステム。
- 前記処理ユニットが、或るボリュームの被検体の組織に対する第一印加電流周波数と第二印加電流周波数との間の抵抗率の相対的パーセント差(RPD)の分布を決定することによって、周波数に対する表面下抵抗率の相対的空間変化を決定するように構成されている、請求項1に記載のシステム。
- 前記処理ユニットが、検出された値と、表面下抵抗率の変化を計算する順モデルによって生成された値との間の誤差を最少化することによって、表面下抵抗率の空間分布を求める逆問題を用いて、印加された電流及び結果としての電圧に基づき、組織領域についての表面下抵抗率の空間分布を推定することによって、前記周波数に対する表面下抵抗率の相対的空間変化を決定するように構成されている、請求項1に記載のシステム。
- 前記出力部が、含水量の指標を備えた前記センサの下の組織領域についての含水量の表現を表すように構成されている、請求項1に記載のシステム。
- 前記コントローラが、複数の異なる周波数での電流の印加が逐次的に行われるように、前記センサ上の電流注入電極対の間における複数の異なる周波数での電流の印加を制御するように構成されている、請求項1に記載のシステム。
- 前記処理ユニットが、印加された電流及び結果としての電圧についての情報を処理して、異なる周波数における見掛け抵抗率を計算し、異なる周波数に対して決定された見掛け抵抗率の相対的パーセント差を決定するように構成されている、請求項1に記載のシステム。
- 前記処理ユニットが、前記見掛け抵抗率の相対的パーセント差の空間分布の傾斜を決定するように構成されていて、前記出力部が、前記傾斜に基づいて肺がドライであることを示すように構成されている、請求項11に記載のシステム。
- 前記傾斜が閾値よりも大きい場合に肺がドライであることを示すように構成されている請求項12に記載のシステム。
- 前記傾斜が正である場合に肺がドライであることを示すように構成されている請求項12に記載のシステム。
- センサを更に備え、前記センサが、平行に配置され且つ前記センサの近位から遠位までの軸に対して横に配置された複数の細長の電極を含み、前記電極が、複数の電圧検知電圧検出電極及び複数の電流印加電流注入電極を備える、請求項1に記載のシステム。
- センサであって、
近位から遠位までの軸に沿って延伸する支持裏地と、
38.1mmから63.5mmの間の長さと、2.54mmから12.7mmの間の幅とを各々有する複数の細長の電極と、を備え、前記電極が、前記電極の長手方向を前記近位から遠位までの軸に対して垂直にして、前記支持裏地の被検体に接触する表面に配置されていて、前記電極が、前記支持裏地の近位から遠位までの軸に平行に直線状に延伸して、前記近位から遠位までの軸に沿って152.4mmから355.6mmの間で延伸する活性領域を形成し、
前記活性領域内の複数の電極が、複数の電流注入電極対及び複数の電圧検出電極対を形成するように構成されている、センサを更に備えた請求項1に記載のシステム。 - 接着性ヒドロゲルを更に備えた請求項16に記載のシステム。
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2012
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- 2012-12-14 EP EP12857702.0A patent/EP2790576A4/en not_active Withdrawn
- 2012-12-14 WO PCT/US2012/069871 patent/WO2013090798A1/en active Application Filing
- 2012-12-14 US US13/715,722 patent/US8700121B2/en not_active Expired - Fee Related
- 2012-12-14 JP JP2014547511A patent/JP2015512658A/ja active Pending
- 2012-12-14 CA CA2858244A patent/CA2858244A1/en not_active Abandoned
- 2012-12-14 AU AU2012351988A patent/AU2012351988B2/en not_active Ceased
-
2014
- 2014-02-03 US US14/171,499 patent/US20140148721A1/en not_active Abandoned
- 2014-06-08 IL IL233010A patent/IL233010A0/en unknown
-
2015
- 2015-08-31 US US14/840,488 patent/US20160051190A1/en not_active Abandoned
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