JP2013081798A - 反復的な治療介入の同期 - Google Patents
反復的な治療介入の同期 Download PDFInfo
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- JP2013081798A JP2013081798A JP2012280150A JP2012280150A JP2013081798A JP 2013081798 A JP2013081798 A JP 2013081798A JP 2012280150 A JP2012280150 A JP 2012280150A JP 2012280150 A JP2012280150 A JP 2012280150A JP 2013081798 A JP2013081798 A JP 2013081798A
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- A61N1/39—Heart defibrillators
- A61N1/3904—External heart defibrillators [EHD]
- A61N1/39044—External heart defibrillators [EHD] in combination with cardiopulmonary resuscitation [CPR] therapy
Abstract
【解決手段】医療装置は、フィードバック合図を生成し、ユーザが胸部圧迫の供給の時機を設定することを補助するように構成されたフィードバック装置と、フィードバック装置によってフィードバック合図が生成される合図時機を決定するように構成されたプロセッサ、メモリおよび関連する回路と、を備える。フィードバック合図はユーザが区別できる2つ以上の位相を有し、第1の位相は救助者の運動の上昇位相に対応し、フィードバック合図の第2の位相は救助者の圧迫運動の下降に対応する。
【選択図】図1
Description
ックを加えるように介護者に通知する。次いで、介護者は、制御ボタンを押してショックを供給することに関与する。ショック供給に続き、SAEDは自動または手動で患者のECGリズムを再び解析し、追加のショックを通知したり、介護者に、患者の循環の徴候を検査し(除細動治療が成功したこと、またはリズムがショック不可能であることを示す)、除細動の試行によって循環が回復されなかった場合、CPRを開始するように指示したりする場合がある。一方、完全に自動式の体外除細動器は、ユーザの介在を待機せずに除細動ショックを加える。以下では、自動式体外除細動器(AED)には半自動式体外除細動器(SAED)が含まれる。
提示されるグラフィカル命令の形態による、高度化されたプロンプトを用いる除細動器について記載されている。1970年代以来のAEDは除細動電極間で測定されるインピーダンスを用いてAEDの状態や救助者に供給する適切なメッセージ(例えば、ユニット上の最初のプロンプトが供給されており、インピーダンスが何らかの所定のしきい値より高いままである場合には「電極を取り付ける(Attach Electrodes)」)を判定していた(あるいは、特許文献15におけるように、過度の患者の動きが存在するか否かを判定していた)。特許文献16には、「電極を取り付ける」などのメッセージを供給するために、電極のインピーダンスを用いてAEDの状態を判定する装置について記載されている。
る反復的な治療は、心臓蘇生の一部として手動で供給される胸部圧迫を含む。実際の供給時機および所望の供給時機は、実際の供給位相および所望の供給位相を含む。実際の供給時機および所望の供給時機は、実際の供給時機と所望の供給時機との間の差を形成することによって比較される。実際の供給時機を徐々に変更するために、複数の治療供給の時間を通じて合図時機が徐々に変更される。フィードバック合図は聴覚的または視覚的である。反復的な治療は心臓蘇生の一部として換気を含む。フィードバック合図はユーザが区別できる2つ以上の位相を有し、第1の位相は供給される治療の第1の位相に対応し、フィードバック合図の第2の位相は供給される治療の第2の位相に対応する。反復的な治療は心臓蘇生のための胸部圧迫を含み、フィードバック合図の第1の位相は救助者の圧迫運動の上昇に対応し、フィードバック合図の第2の位相は救助者の圧迫運動の下降に対応する。フィードバック合図は可聴音を含み、第1の位相および第2の位相は周波数および振幅のうちの一方または両方において異なる。フィードバック合図は胸部圧迫のための上昇合図を含み、上昇合図は、圧迫の供給前の上昇中に救助者の体が上昇するにつれて、周波数が増加するように変化する。フィードバック合図は圧迫の供給中に時間によって周波数の変化する下降合図を含む。下降合図は上昇合図より持続時間が短い。下降合図の音量は供給される圧迫がほぼ底にある時に最高となるように増大する。プロセッサは、合図時機と実際の供給時機との間の遅延時間を決定するように、かつ、合図時機を決定する際に遅延時間および所望の供給時機を使用するように構成されている。プロセッサは、合図時機と実際の供給時機との間の類似の時間関係を維持するように構成されている。類似の時間関係は実際の供給時機の前に合図時機を発生させる。プロセッサは、トラッキングフィルタを用いて、反復的な治療を供給する際のユーザの過去の成績に基づき、実際の供給時機を予測するように構成されている。トラッキングフィルタはカルマン(Kalman)フィルタを含む。プロセッサは、合図時機と実際の供給時機との間のヒステリシス関係を補償するように構成されている。トラッキングフィルタは、所望の供給時機からの実際の供給時機の短時間の解離の影響を制限するように構成されている。ローパスフィルタによって供給時機の短時間の解離の影響が制限される。所望の供給時機は患者の測定される生理機能に基づき選択される。測定される生理機能は患者のECGを含む。所望の供給時機はECGにおけるT波以外の時である。測定される生理機能は心臓のPEAであり、所望の供給時機は、PEAに関連して位相の設定された実際の胸部圧迫時機を生成し、血行動態の出力を改善するように選択される。測定される生理機能は心臓の低レベルの機械的活動であり、所望の供給時機は、低レベルの機械的活動に関連して位相の設定された実際の胸部圧迫時機を生成し、血行動態の出力を改善するように選択される。測定される生理機能は心臓のリズム状態を含み、プロセッサは、リズム状態における少なくとも幾つかの変化にしたがって合図時機を変化させるように構成されている。患者の基調となる循環器系活動に関連してフィードバック合図の位相を設定するか否かを決定する際にリズム状態が考慮される。測定される生理機能は特定の生理学的事象の時機を含み、合図時機は、生理学的事象の時機と実際の供給時機との間の所望の時間関係を生成するように選択される。生理学的事象は心臓の機械的収縮である。所望の供給時機は、ペーシング刺激によって生じる改善された心筋の緊張の期間に胸部圧迫が発生するように、心臓に供給されるペーシング刺激の直後に続く。
モデルによって構成されている。
は食道の開口部にまたは開口部の中に挿入されるように構成されており、プローブは、背骨に向けて後部の方へ、ほぼ頚椎C3−C6に超音波エネルギーを供給し、測定し、脊椎骨および血管の両方から反射される超音波エネルギーを測定するように構成されている。
心臓は除細動ショック後の回復の初期段階にあり、多くの場合、電気活動はリズミカルであるものの機械的出力の低下した状態であるので、本発明によって、胸部圧迫が回復中の心臓の正常な機械的活動(低レベルであっても)に同期されることにより、心臓の回復が強化される。本発明は、非潅流の細動リズムの患者やPEAなど血行動態的に不安定または無効なリズムの患者に有効なCPRを供給するのを支援することができる。
不全収縮のリズムはCPR中に自然にPEAに変化する場合があり、現在通常実行されているようなPEA中の胸部圧迫の非同期な供給は、循環系の血行動態に関して本質的に最適なものではない。ショック後のPEAなど、これらの回復の初期段階においては、実際には心臓はある程度収縮しており、圧迫の位相を非同期とすることによって、心筋に対する追加のストレスや、より低い駆出分画が与えられる場合がある。本発明では、1つのリズム状態から次のリズム状態への心臓の変化を検出し、救助者の換気及び胸部圧迫など
CPR活動の位相を心臓および肺の基調となる電気および機械的活動に同期させる(同調させる)フィードバックを、救助者に供給することができる。これには、胸部圧迫の中断の必要を減少させること、および血行動態を改善することの両方の利点が存在する。
入力信号をフィードバックトーン(または他の圧迫フィードバック合図)に変換するア
ルゴリズムは、複雑さが異なってよい。このアルゴリズムは、ECG信号におけるQRS群または他の関心の点を検出する程度の単純なものであってもよい。あるいは、このアルゴリズムは、カルマンフィルタ、または過去の読取値を用いて次の圧迫が生じるべき時を予測する他の方法など、予測的なトラッキングアルゴリズムを含む、より複雑な方法を含んでもよい。予測された圧迫時機を用いて、フィードバック合図の供給される時機が即座に更新されてもよく、あるいは(図2に示すように)、複数の圧迫を通じてフィードバック合図のタイミングがゆっくり調整され、救助者が圧迫のリズムをゆっくり変化させ、圧迫を所望のタイミングに至らせることを可能としてもよい。
1、パルスオキシメトリ2、侵襲性血圧および非侵入性血圧などによって測定される血行動態状態である、患者の生理学的な状態から生成される。H’(kT)56は、X(kT)64のレートおよび位相が患者の現在の生理学的な状態に最大の利益を提供するように最適化されるよう、X(kT)64を調整するようにフィードバックされる。
UPT開始=t0+{P−[φ−(δt+1−ψt+1)+(1/σ*Δf)]} 。
定し、次いで、(ノイズを含む)測定値の形態のフィードバックを得る。そのため、カルマンフィルタの方程式は、複数の時間更新方程式および複数の測定値更新方程式の2つの群となる。時間更新方程式は、現在の状態の前方(時間)および誤差共分散推定値を予測し、次の時間ステップに対する演繹的な推定値を得ることを担う。測定値更新方程式はフィードバックを担う。すなわち、新たな測定値を演繹的な推定値に組み込み、改善された帰納的な推定値を得ることを担う。測定値更新方程式は修正方程式と考えられ、時間更新方程式は予測方程式と考えられる。実際、最終の推定値アルゴリズムは、数値問題を解くための予測−修正アルゴリズムに類似している。
非ガウス分布で非線形のフィルタリングの問題を解決する最もよく知られているアルゴリズムは、拡張カルマンフィルタ(EKF)である。このフィルタは、テイラー級数展開を用いて測定値および発展モデルを線形化する原理に基づく。しかしながら、EKFアルゴリズムにおける級数近似は、関心の非線形関数および確率分布の不十分な表現が導かれることがある。その結果、このフィルタは発散することがある。任意の非線形関数を近似することよりガウス分布を近似することの方が容易であるという仮説に基づき、他の研究者らは、無香(unscented)カルマンフィルタ(UKF)と呼ばれるフィルタを開発した。UKFではEKFより正確な結果が導かれること、詳細には、充分により良好な状態の共分散の推定値を生成する(EKFでは多くの場合この量が過小評価されると思われる)ことが示されている。しかしながら、UKFには、ECGスペクトル分布の場合に多く見られる一般的な非ガウス分布に適用されないという制限が存在する。粒子フィルタとしても知られる逐次モンテカルロ法によって、この制限が克服され、平均、モード、尖度および分散などの任意の統計推定値を容易に計算可能であるように、状態の後の分布の完全な表現が可能となった。したがって、粒子フィルタによって、任意の非線形性または分布が処理される。粒子フィルタは重点サンプリングに依っており、その結果、後の分布を適度に十分に近似可能な予測分布の設計を必要とする。一般に、そのような予測を設計することは困難である。最も一般的なストラテジーは、状態発展(先の遷移)の確率モデルからサンプリングを行うことである。しかしながら、新たな測定値が先の測定値のテールに出現する場合、あるいは尤度が先の尤度と比較して尖鋭すぎる場合、このストラテジーは失敗することがある。
初期化:t=0.
i=1,...Nについて、先のp(x0)から状態(粒子)x0 (i)を取り出し設定する、
a)重点サンプリングステップ:
i=1,...Nについて:UKFを用いて粒子を更新:
シグマ点を計算:
b)選択ステップ
それぞれ高重点/低重点重み
c)出力:このアルゴリズムの出力は、後の分布を近似するために使用可能な次式の1組のサンプルである:
ステリシスが存在する。
フィードバックのタイミングを判定するために、患者の生理機能についての様々な種類の情報が入力として用いられてよい。例えば、次の生理学的な信号のうちのいずれか、または複数の生理学的な信号の組み合わせを用いることも可能である:ECG、心拍出量の測定値、心拍の測定値、血圧、酸素飽和度(SpO2)、心音(心音図検査を含む)、心臓画像処理(超音波を含む)、インピーダンスカルジオグラフィー。
は、好適には、知覚的に分類可能な観点から、圧迫および換気のそれぞれのフィードバックトーンを認識可能な別個のものとすることによって達成可能である。例えば、圧迫用のトーンはトランペットとして理解される波形および和声を有し、換気はバイオリンとして理解されるが波形および和声を有することができる。音声合成に共通する技術を用いて、各々のトーンについて基本周波数を変位させ、フィードバックに必要な周波数を変化させることができる。
な実施形態では、まさに言及したような医療知識が、Crit Care Med、2000年、第28巻、第11号(補遺)に記載のものなど、循環系の数学的記述と組み合わされる。この著者が記載するように、微分方程式のシステムは複数の刊行物に記載されている。この特定の例では、“ヒトの循環は血液が流動できる抵抗によって接続された7つの弾性の室によって表現される。弾性体は、胸大動脈、腹大動脈、上大静脈および右心、腹部および低末端静脈、頚動脈、ならびに頚静脈に相当する。加えて、胸郭は、肺血管および左心の弾性体を表現するポンプを含む。このポンプは、加えられる圧力によって心臓自体から大動脈弁を通じて血液を絞り出す心臓状の心臓ポンプとして、あるいは加えられる圧力によって肺血管床から左心を通じて周囲へ血液を搾り出す全体的な胸部圧力ポンプとして、機能するように構成され得る。教科書的な普通の「70kgの男性」を記述する生理学的変数の値を用いて、モデルにおける弾性および抵抗を指定する。頭部、胸部および尾部の構成要素への血管のコンダクタンス(1/抵抗)の分布は、様々な身体領域に対する心拍出量の教科書的な分布を反映している”とある。
たは他のトランスデューサが用いられる。この音は、訓練された救助者7に対しスピーカ6を通じて増幅されてもよく、訓練のより少ない救助者7に合図を供給するように処理されてもよい。心音は、CPRレート、深度、デューティサイクルまたはその両方を判定するため、およびCPRの有効性を評価するために、他の測定値から独立して用いられてよい。これは、ECG 1、血圧または脈拍が自然なレートまたは心臓の圧迫される時機を示唆しない不全収縮において、患者11に有効な場合がある。圧迫のDPT 39位相の速度は弁膜逆流を最小化するように調整されてよい。適切な圧迫の深度は、弁閉止を示す心音によって評価されてよい。
ーサアレイを使用することによって、またはプローブ面への音響レンズを組み込むことによって形成され、約45度のビーム方位角を有する狭い上昇ビームを生じる。トランスデューサは、音響ビームに総頸動脈と頚静脈とを交差させるようにプローブに配置され、上昇ビーム角が狭いため、狭い領域においてのみ頚動脈および頚静脈と交差し、血流速度の精度を改善する。頚動脈および頚静脈の両方の血流速度は、ドップラ偏移2fcv/cを用いて同時に計算される。ここで、fc、vおよびcは、それぞれ音響ビームの中心周波数、血流速度および音速である。
れてもよい。
時に15秒でPPIを0とするレートで減少することが所望された。選択された特定の値は、部分的には、アメリカ心臓協会(AHA)によって提案されている、換気対圧迫について30:2の比の新たなCPRガイドラインによった。通常、休止は換気の実行されるときに発生するので、PPIは分間の換気サイクルにより生じる休止の終了によって著しく低下する。しかし、良好な圧迫が実行される場合、1分間のCPR間隔の終了に発生する除細動ショックの直前に100まで戻る。救助者の目標はショック直前に100に近いPPIを得ることである。PPIはショック後に0にリセットされるので、救助者はショック直後に圧迫を開始するように動機付けを行われる。図12Cには、別の可能なグラフィカルなフィードバック実施形態を示す。PPIブロック120の外側の厚い帯(幅約3.2mm(約1/8インチ))は、良好な圧迫(約3.81cm(1.5インチ)以上)が供給された後、1秒間緑になり、次いで黒に戻る。「不良な」圧迫(約3.81cm(1.5インチ))が供給されると、この帯は1秒間赤くなり、次いで再び黒に戻る。目標はPPIの輪郭の帯120を緑色にしておくことである。PPIブロック121は、Perfusion_Perf_Ind値に基づき満ちる(Perfusion_Perf_Ind=32896のとき完全)。より複雑な実施形態では、換気と圧迫との相互作用またはBabbsによって記載されるより完全なモデルが組み込まれてよい。
バイザリ方法の解析の結果に基づき、AED 10は、自動的に患者11に適切な治療を供給することができる。また、AED 10は「アドバイザリ」モードにより構成されてもよい。「アドバイザリ」モードでは、AED 10は、AED 10が最も良好な治療の決定を行った後、介護者にプロンプトを示す。治療が患者へ供給される前に、ボタン押下または音声検出の承認の形態の介護者/装置操作者による承認が要求される。
Claims (33)
- ユーザが手動で患者へ反復的な治療を供給することを補助するために用いられる種類の医療装置であって、
ユーザが反復的な治療を供給する供給時機を設定することを補助するためのフィードバック合図を生成するように構成されたフィードバック装置と、
ユーザが実際に反復的な治療を供給した実際の供給時機を検出するように構成された1つ以上のセンサまたは回路部品と、
実際の供給時機を所望の供給時機を表す情報と比較し、該比較結果に基づいて、フィードバック装置がフィードバック合図を生成する合図時機を決定するように構成されたプロセッサ、メモリおよび関連する回路と、からなる装置。 - 手動で供給される反復的な治療は、心臓蘇生の一部として手動で供給される胸部圧迫を含む請求項1に記載の装置。
- 実際の供給時機および所望の供給時機は、実際の供給位相および所望の供給位相を含む請求項2に記載の装置。
- 実際の供給時機および所望の供給時機は、実際の供給時機と所望の供給時機との間の差を形成することによって比較される請求項2に記載の装置。
- 実際の供給時機を徐々に変更するように、複数の治療供給の時間を通じて合図時機が徐々に変更される請求項2に記載の装置。
- フィードバック合図は聴覚的または視覚的である請求項2に記載の装置。
- 反復的な治療は心臓蘇生の一部として換気を含む請求項2に記載の装置。
- フィードバック合図はユーザが区別できる2つ以上の位相を有し、第1の位相は供給される治療の第1の位相に対応し、かつ、フィードバック合図の第2の位相は供給される治療の第2の位相に対応する請求項1に記載の装置。
- 反復的な治療は心臓蘇生のための胸部圧迫を含み、フィードバック合図の第1の位相は救助者の圧迫運動の上昇に対応し、かつ、フィードバック合図の第2の位相は救助者の圧迫運動の下降に対応する請求項8に記載の装置。
- フィードバック合図は可聴音を含み、第1の位相および第2の位相は周波数および振幅のうちの一方または両方において異なる請求項9に記載の装置。
- フィードバック合図は胸部圧迫のための上昇合図を含み、上昇合図は、圧迫の供給前の上昇中に救助者の体が上昇するにつれて、周波数が増加するように変化する請求項10に記載の装置。
- フィードバック合図は圧迫の供給中に時間によって周波数の変化する下降合図を含む請求項11に記載の装置。
- 下降合図は上昇合図より持続時間が短い請求項12に記載の装置。
- 下降合図の音量は供給される圧迫がほぼ底にある時に最高となるように増大する請求項12に記載の装置。
- プロセッサは、合図時機と実際の供給時機との間の遅延時間を決定するように、かつ、合図時機を決定する際に遅延時間および所望の供給時機を使用するように構成されている請求項1に記載の装置。
- プロセッサは、合図時機と実際の供給時機との間の類似の時間関係を維持するように構成されている請求項1に記載の装置。
- 前記類似の時間関係は実際の供給時機の前に合図時機を発生させる請求項16に記載の装置。
- プロセッサは、トラッキングフィルタを用いて、反復的な治療を供給する際のユーザの過去の成績に基づき、実際の供給時機を予測するように構成されている請求項1に記載の装置。
- トラッキングフィルタはカルマンフィルタを含む請求項18に記載の装置。
- プロセッサは、合図時機と実際の供給時機との間のヒステリシス関係を補償するように構成されている請求項18に記載の装置。
- トラッキングフィルタは、所望の供給時機からの実際の供給時機の短時間の解離の影響を制限するように構成されている請求項18に記載の装置。
- ローパスフィルタによって供給時機の短時間の解離の影響が制限される請求項21に記載の装置。
- 所望の供給時機は患者の測定される生理機能に基づき選択される請求項2に記載の装置。
- 測定される生理機能は患者のECGを含む請求項23に記載の装置。
- 所望の供給時機はECGにおけるT波以外の時である請求項24に記載の装置。
- 測定される生理機能は心臓のPEAであり、所望の供給時機は、PEAに関連して位相の設定された実際の胸部圧迫時機を生成し、血行動態の出力を改善するように選択される請求項23に記載の装置。
- 測定される生理機能は心臓の低レベルの機械的活動であり、所望の供給時機は、低レベルの機械的活動に関連して位相の設定された実際の胸部圧迫時機を生成し、血行動態の出力を改善するように選択される請求項23に記載の装置。
- 測定される生理機能は心臓のリズム状態を含み、プロセッサは、リズム状態における少なくとも幾つかの変化にしたがって合図時機を変化させるように構成されている請求項23に記載の装置。
- 患者の基調となる循環器系活動に関連してフィードバック合図の位相を設定するか否かを決定する際にリズム状態が考慮される請求項28に記載の装置。
- 測定される生理機能は特定の生理学的事象の時機を含み、合図時機は、生理学的事象の時機と実際の供給時機との間の所望の時間関係を生成するように選択される請求項23に
記載の装置。 - 生理学的事象は心臓の機械的収縮である請求項30に記載の装置。
- 所望の供給時機は、ペーシング刺激によって生じる改善された心筋の緊張の期間に胸部圧迫が発生するように、心臓に供給されるペーシング刺激の直後に続く、請求項2に記載の装置。
- フィードバック合図は非言語的合図である請求項1に記載の装置。
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