JP5281002B2 - うっ血性心不全患者の携帯型自動モニタリング - Google Patents
うっ血性心不全患者の携帯型自動モニタリングInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/024—Detecting, measuring or recording pulse rate or heart rate
- A61B5/02405—Determining heart rate variability
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7235—Details of waveform analysis
- A61B5/7253—Details of waveform analysis characterised by using transforms
- A61B5/7257—Details of waveform analysis characterised by using transforms using Fourier transforms
Description
図1A〜Bは、モニタされた患者で測定されたPBの2つの例を示す。図1A〜Bの横のスケールは、時間である。図1Aは、2分の間にわたるCHF患者の有意な周期性変動呼吸を示す。ここでは、上の記録は経時的な肺容量(Vt)を表し、下の記録は毎分換気量(VE)を表す。上の記録から、個々の呼吸量がPBの特性を幾分、増減することは明らかである。また、この患者の残余の肺気量は呼吸が増加した期間に増加して、呼吸が減少した期間に減少する。下の記録から、VEが一様に上の値と低い値(すなわちほぼ0)の間を変化することは、明瞭である。図1Bが高地の健常な患者における顕著なPBや急性低酸素症(減少したSaO2)を示す。Vtを示す上の記録は、この患者が、呼吸が減少した期間に呼吸が実際に止まる(無呼吸)ことを示す。この図における他の記録はパラメータを示す。RCとABは胸郭のサイズと腹部のサイズを示し、VT(Vt)はここではRCとABの記録の合成である肺容量であり、RRは呼吸数を示し、Ti/Totは全体の呼吸時間(Tot)で割った吸気の時間(Ti)を示し、SaO2は血液酸素飽和度を示し、そしてHRは心拍数を示す。VtはRCとABの線形和として厳密に算定され、そして、VEはVtかける呼吸数である。
ここでxiは、オリジナルデータ系列の入力データ値Nであり、これらは、M=N/T、入力データポイントTを有する各ブロックである連続したブロックMに分けられ、代表値νj rを形成するために平均化されたj番目のブロックのデータポイント、そして、νj r 1<=j<=Tは派生した系列の出力値である。派生したデータ系列が入力データ系列のスケールのT倍のスケールを持つことを考慮する。例えば、Costaら、2002年、合成の生理学的時系列のマルチスケール解析、Phys. Rev. Lett. 89(6)を参照。データ値は、代表的な値を構成するために、他の統計技術によって組み合わせることもできる。また、データブロックは部分的に重複できる。データ時系列を分析する代わりに、マルチスケールのエントロピーは、時系列の変換係数に適用することもできる。
p(νj T)はデータセットの値νj Tの出現確率である(例えば、データの標準化されたヒストグラム)。容易に決定されるにもかかわらず、それが入力データ系列のノイズとアーチファクトによって容易に歪められるので、普通のエントロピーはあまり好まれない。KSエントロピーはシステムの動力学を特徴づけるのに有用なパラメータであって、情報の生成の割合の平均を示す。計算的に容易であるが、これと同様なものとして、本質的に有限期間系列の上のKSエントロピーの評価である近似エントロピー(ApEn)がある。発見的に、E−RエントロピーとApEnは、接近したパターンの流れが次のインクリメント式の比較に近いままである(対数の)尤度を評価する。
SampEn(k,r,N)=−In(A(k)/B(k−1)
k=0,1・・・,m−1、B(0)=N(入力系列の長さ)。
本発明は、HRV測定を曲解する入力データにおける異常を認識して、除去することによって、HRVのより信頼性が高く正確な測定のための方法を与える。前置きとして、HRV測定と入力データ異常を認識する既知の方法を簡潔に述べる。まず、心拍数データの時間領域分析及び周波数領域分析によるHRV測定の標準分析法が知られている。Carumら、1996年を参照(前述した)。入力心拍数データは、大抵並列の心電図(ECG)記録の連続したR波間の時間的間隔(R−R間隔)として測定される。R波出現は既知の方法によってECGで容易に認識され、R−R間隔はそれで連続したR波出現の間の時間的間隔の系列である。入力RR間隔データの異常はHRVを深刻に歪め、そして、特定の治療がそのような異常が十分にない「きれいな」データを選択する際に必要である。異なる「クリーニング」方法は、異なるタイプの異常の場合適用される。
と
と
ここで、Vpeak(Vtrough)は、代表的な値からの有意な変化が現在のウインドウの信号の極大(極小)にある場合、上記の式にしたがってFalseにセットされるブール変数である。Nは現在のウインドウの呼吸の数、
はN回の信号極大を代表し、
はN回の信号極小を代表し、
はN回の一回換気量(吸気の終わりの量引く前の呼気の終わりの量)。この典型的な実装例において、代表的な値は中央値として測定する。更に、BIjはj番目の極小値であり、EIjはj番目の極大値である。Vthreshは、(一回換気量の代表的な値によって標準化したものとして)現在の値と代表的な値の差が有意である(代わりに、異なる閾値が、信号の極大と極小に選択できる)とみなされる選択された閾値である。VpeakとVtroughは、上記の式によって計算されたブール値である。Vrは安定した呼吸が検出されるとTrueにセットされるブール変数である。他の実施例において、安定した谷が検出される、または、安定した谷と頂点が検出されると、VrはTrueである。
と
VpeakやVtroughを決定する他の関連した方法は明瞭で、本発明の範囲内にある。また、ブールの閾値テストは、他のテスト方式と置き換えられる。例えば、極大(極小)の特定の部分が閾値を上回る場合だけ、Vpeak(Vtrough)はFalseにセットできる。
胸部カルジオグラフィー(TCG)は、腹側の胸部サイズの経時的測定から、非侵襲的に心拍出量(CO)の指標を与える。心臓の拡張期と収縮期を反映する心臓の拍動は、覆っている腹側の胸部のサイズ(例えば剣状突起の高さの横径部分の長さ)に影響を及ぼしうる。呼吸が腹側の胸部サイズの変化に優位であるとはいえ、吸息と呼息よりかなり少ない振幅ではあるが、心臓の活動と心臓の拍動は腹側の胸部サイズを変える。フィルタリングと平均化技術(例えば、集合平均化)は明確に心臓の活動を、より大きい呼吸活動から抽出するために開発された。全体としてこの中の参照によってこの中に組み込まれる1993年発行の米国特許番号5,178,151、2004年発行の6,783,498及び、2004年11月18日申請の米国出願10/991,877を参照。これらの技術は、標準的で侵襲的な技術で測定される実際の心拍出量データを反映する(または、単調に相関する、または、ほぼ比例する)心拍出量の指標を与える。
本発明の上記の方法に入力する、若しくは分析されるモニタリング・データは、例えば、多種多様なモニタリングシステムによって集める、病院内用、クリニック用若しくは携帯使用や他の環境出の使用のために設計したシステムのような幅広い種類のモニタリングシステムによって集められる。本発明の好適な実施形態は、患者が実質的に抑制されない方法で正常な日常活動を行う間にモニタリング・データが集められる、携帯型モニタリングを目的とする。また、本発明の方法は、携帯型システムからサーバ型システムまでの広範囲のコンピュータシステムに実装できる。本発明の好適な実施形態は、本発明の方法を移動する患者によって容易に持ち歩かれる携帯用の処理装置に実装する。そのような好適な実施形態において、患者のCHFの状態は直ちに患者が利用でき、後の検査のために介護者に遠隔で送信もできる。
本発明は、以下の内容を包含する。
[1]
患者の呼吸および心臓の生理の非侵襲的モニタリングによって生じる信号を受信して、前記信号は少なくとも前記患者の呼吸速度と容量及び前記患者の心拍数に関する情報を伝達し、
前記受信した信号に周期性変動呼吸(PB)の指標がないか検査し、
前記受信した信号に心拍変動(HRV)の低下の指標がないか検査し、
前記PBの指標及び前記HRVの指標に基づいて前記患者のCHFの状態を示すこと
を含む患者におけるうっ血性心不全(CHF)を自動的にモニタリングする方法。
[2]
前記患者が移動するときに、前記信号の少なくとも一部を受信する[1]に記載の方法。
[3]
PBの指標が見られる場合またはHRVの低下の指標が見られる場合に、CHFの重症度が増すことを知らせる[1]に記載の方法。
[4]
前記受信した信号が前記患者の心臓拍動の大きさに関する情報も伝達し、前記受信した信号に心拍出量(CO)の指標がないか検査し、PBの指標が見られる場合、または、HRVの低下の指標が見られる場合、または、還元型COの低下の指標が見られる場合に、CHFの重症度が増していることを知らせる[1]に記載の方法。
[5]
前記受信した信号は前記患者の血液酸素含量(spO2)に関する情報も伝達し、spO2の低下の指標が見られる場合、または、spO2の指標がない場合、または、PBが見つかる場合には、CHFの重症度が増していることを知らせる[1]に記載の方法。
[6]
前記患者の呼吸および心臓の生理をモニタリングして、少なくとも前記患者の呼吸速度と容量及び前記患者の心拍数に関する情報を伝達する信号を与える非侵襲性のセンサを有する装着型アイテムと、
前記センサの信号に周期性変動呼吸(PB)の指標がないか検査し、
前記センサの信号に心拍変動(HRV)の低下の指標がないか検査して、
前記PBの指標及び前記HRVの指標に基づいて前記患者のCHFの状態を示すために前記センサに有効に接続するコンピュータとを、
含む患者におけるうっ血性心不全(CHF)を自動的にモニタリングするシステム。
[7]
ガーメントは大きさを変更され、シャツの一部または、一つ以上のバンドとして構成されることを特徴とする[6]に記載のシステム。
[8]
前記コンピュータが携帯用のデジタル補助手段と類似する大きさ及び構造を有する[6]に記載のシステム。
[9]
前記システムが大きさを変更されて、控え目に着用されておよび/または移動する患者によって携帯されるように構成される[6]に記載のシステム。
[10]
前記非侵襲性のセンサが心電図(ECG)信号を感知しうる電極センサ、または時間で変化する患者のサイズを感知しうる誘導プレチスモグラフィ・センサの一つ以上を含む[6]に記載のシステム。
[11]
前記非侵襲性のセンサが前記患者における患者の胸郭(RC)、または患者の腹部(AB)の時間で変化するサイズを感知しうる一つ以上のセンサを含み、前記コンピュータが前記RCおよび/または前記AB信号に基づいて時間で変化する肺容量信号を判定する[6]に記載のシステム。
[12]
与えられた前記センサの信号が前記患者の心臓の時間で変化する拍動(TCG)を感知しうる信号を一つ以上含み、前記コンピュータが前記TCGの信号から心拍出量(CO)の指標を測定して、前記COの指標に更に基づいてCHFの状態を知らせる[6]に記載のシステム。
[13]
前記患者の呼吸生理を非侵襲的にモニタリングすることによって生じる信号を受信して、前記信号は少なくとも前記患者の呼吸速度及び容量に関する情報を伝達し、
前記受信した信号に周期性変動呼吸(PB)の指標がないか検査し、
PBの指標が見られる場合に、重症度が増しているとして前記患者のCHFの状態を知らせること
を含む患者におけるうっ血性心不全(CHF)を自動的にモニタリングする方法。
[14]
前記受信した信号から一定のサンプリング・レートでサンプリングした毎分換気量(VE)信号を判定することを更に含む[13]に記載の方法。
[15]
0時間シフトと複数の0以外の時間シフトでVE信号を自動相関させることによって自動コレログラムを形成して、
前記自動コレログラムにPBの指標がないか検査し、前記自動コレログラムが0時間シフトの中央の極大に隣接する0以外の時間シフトの有意な極大を含む場合にはPBを知らせること
を前記検査の工程が更に含む[14]に記載の方法。
[16]
前記VEデータのフーリエ変換法によるパワースペクトルを形成して、前記VEデータに窓を掛け、
前記パワースペクトルにPBの指標がないか検査し、前記パワースペクトルがPBの周波数特性に有意な極大を含む場合にはPBを知らせること
を前記検査の工程が更に含む[14]に記載の方法。
[17]
前記VEデータのロム−スカーグル法によるパワースペクトルを形成して、前記VEデータに窓を掛け
前記パワースペクトルにPBの指標がないか検査し、前記パワースペクトルがPBの周波数特性に有意な極大を含む場合にはPBを知らせること
を前記検査の工程が更に含む[14]に記載の方法。
[18]
前記VEデータのバーグ法によるパワースペクトルを形成して、前記VEデータに窓を掛け、
前記パワースペクトルにPBの指標がないか検査し、前記パワースペクトルがPBの周波数特性に有意な極大を含む場合にはPBを知らせること
を前記検査の工程が更に含む[14]に記載の方法。
[19]
前記受信した信号が前記患者の胸郭(RC)、前記患者の腹部(AB)の一方または両方の時間で変化するサイズに関する情報を伝達し、
前記検査の工程が、自動相関法とフーリエ変換法とロム−スカーグル法及びバーグ法の一つ以上によって、前記受信した信号のパワースペクトルを形成することを更に含み、
前記パワースペクトルにPBの指標がないか検査して、前記パワースペクトルがPBの周波数特性と呼吸の周波数特性において、2つの有意な極大を含む場合にはPBを示す
[13]に記載の方法。
[20]
パワースペクトルを形成する工程の前に、前記受信した信号をトレンド除去し、前記トレンド除去した信号を調整することを更に含む[19]に記載の方法。
[21]
複数の付加的な信号の複数のエントロピーを計算し、前記複数の付加的な信号は、窓を掛けて続いて複数の粗さのグレイニングをすることにより前記受信した信号から導かれ、
粗さが小さな段階のグレイニングにおけるエントロピーと粗さが大きな段階のグレイニングにおけるエントロピーとを比較することによって、前記複数のエントロピーにPBの指標がないか検査すること
を前記検査の工程が更に含む[13]に記載の方法。
[22]
一つ以上の前記エントロピーがサンプル・エントロピー法によって計算される[21]に記載の方法。
[23]
患者の心臓生理を非侵襲的にモニタリングすることによって生じる信号を受信して、前記信号は少なくとも患者の心拍数に関する情報を伝達し、
前記受信した信号に心拍変動(HRV)の低下の指標がないか検査し、
HRVの低下の指標が見られる場合には、重症度が増しているとして前記患者のCHFの状態を知らせること
を含む患者におけるうっ血性心不全(CHF)を自動的にモニタリングする方法。
[24]
前記受信した信号が前記患者の呼吸生理を更にモニタリングして、前記患者の呼吸速度と容量に関する情報を伝達し
前記受信した信号に周期性変動呼吸(PB)の指標がないか検査し、
PBが検出される期間において、前記受信した信号にHRVの減少の指標がないか検査するのを中止することを更に含む
[23]に記載の方法。
[25]
前記受信した信号が前記患者の呼吸生理を更にモニタリングして、前記患者の呼吸速度と容量に関する情報を伝達し、
前記受信した信号に呼吸変動が異常に増加した周期がないか検査し、
呼吸変動性が異常に増加した周期において、前記受信した信号にHRVの減少の指標がないか検査するのを中止することを更に含む
[23]に記載の方法。
[26]
前記受信した信号に呼吸変動が異常に増加した周期がないか検査する工程が
先のウインドウの周期と後のウインドウの周期に信号の極大または極小の位置または値を同定し、
前記後のウインドウの周期に同定された前記位置と値が、前記先のウインドウの周期に同定された前記位置と値に有意差があるか否かを判定し、
有意差が判定された場合には、前記後のウインドウの周期に呼吸変動が異常に増加した指標を与えること
を更に含む[25]に記載の方法。
[27]
2つの値の差が予め定められた閾値を上回る場合には、2つ値に有意差がある[26]に記載の方法。
[28]
前記信号の極大または前記信号の極小のうち両方ではなく、1つだけが同定されて、比較される[26]に記載の方法。
[29]
前記信号の極大および/または前記信号の極小の、値または位置の両方ではなく、1つだけが同定されて、比較される[26]に記載の方法。
[30]
信号の極大および/または極小の前記位置だけが同定されて、比較される[26]に記載の方法。
Claims (4)
- 患者の呼吸及び心臓の生理を非侵襲的にモニタリングすることにより生じる信号を受信して、前記信号は少なくとも前記患者の呼吸速度及び前記患者の心拍数に関する情報を伝達し、
前記受信した信号に周期性呼吸(PB)の指標がないか検査し、
前記受信した信号に心拍変動(HRV)の低下の指標がないか検査し、
前記PBの指標及び前記HRVの指標に基づいて前記患者のCHFの状態を示すコンピュータを含み、
PBが生じていた周期からの心電図(ECG)記録の連続したR波間の時間的間隔(R−R間隔)のデータからHRVは測定され、
前記信号の極大または極小における有意な変化は、前のウインドウにおいて認める信号の極大および極小を代表する値を見つけること、および、次いで代表する値から現在のウインドウのセンサ信号の極大または極小の違いを閾値設定することによって測定され、当該閾値設定が下記式を用いて行われる、患者のうっ血性心不全(CHF)を自動的にモニタリングするシステム。
[上記式中、代表する値からの有意な変化が現在のウインドウの信号のいずれかの極大にある場合、Vpeakは上記の式にしたがってFalseにセットされるブール変数であり、代表する値からの有意な変化が現在のウインドウの信号のいずれかの極小にある場合、Vtroughは上記の式にしたがってFalseにセットされるブール変数である。Nは現在のウインドウの呼吸の数、
はN回の信号極大を代表し、
はN回の信号極小を代表し、
はN回の換気量を代表する。代表する値は中央値として測定する。更に、BIjはj番目の極小値であり、EIjはj番目の極大値である。Vthreshは、現在の値と代表する値との間の差が有意であるとみなされる上記の選択された閾値である。VpeakとVtroughは、上記の式によって計算されたブール値である。Vrは安定した呼吸が検出されるとTrueにセットされるブール変数である。] - PBの指標が検出されるか、HRVの低下の指標が検出された場合に、CHFが重症度を増すことを知らせる請求項1に記載のシステム。
- 前記受信した信号が、前記患者の心拍動の振幅に関する情報も伝達し、前記受信した信号が心拍出量(CO)の指標を検査され、PBの指標が検出されるか、HRVの低下の指標が検出されるか、COの減少の指標が検出された場合に、前記CHFが重症度を増すことを知らせる請求項1に記載のシステム。
- 前記受信した信号が、前記患者の血液酸素含量(spO2)に関する情報も伝達し、spO2減少の指標が検出されるか、spO2減少の指標が検出されないがPBが検出された場合に、CHFが重症度を増すことを知らせる請求項1に記載のシステム。
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US11/764,527 US8475387B2 (en) | 2006-06-20 | 2007-06-18 | Automatic and ambulatory monitoring of congestive heart failure patients |
PCT/US2007/071562 WO2007149856A2 (en) | 2006-06-20 | 2007-06-19 | Automatic and ambulatory monitoring of congestive heart failure patients |
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