JP5660890B2 - 血管アクセス及びガイダンスシステム - Google Patents
血管アクセス及びガイダンスシステム Download PDFInfo
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- JP5660890B2 JP5660890B2 JP2010515139A JP2010515139A JP5660890B2 JP 5660890 B2 JP5660890 B2 JP 5660890B2 JP 2010515139 A JP2010515139 A JP 2010515139A JP 2010515139 A JP2010515139 A JP 2010515139A JP 5660890 B2 JP5660890 B2 JP 5660890B2
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Description
・抗生物質、化学療法剤、およびその他のIV薬剤などの薬の投与。
・流体や栄養剤(過栄養)の投与。
・血液製剤の注入。
・血液透析。
・診断試験用採血。
患者の血管系にアクセスするように構成されて細長いフレキシブル(柔軟)な部材と、
細長いフレキシブルな部材の末端に配置され、生体の非結像超音波又は近赤外光を用いて、患者の血管の血管内心電図信号及び血流プロファイル情報を提供し、温度測定値、圧力測定値を提供するように構成されたセンサ、及び血液速度情報を提供する測定値を提供するその他のセンサと、
血流速度情報と、センサから提供された患者の血管の血管内心電図信号を受信し、処理し、関連付けるとともに、患者の血管内の細長いフレキシブルな部材の末端の位置に関する位置情報を提供するプロセッサと、
プロセッサからの位置情報を出力するように構成された出力装置を有する。
体の血管系にアクセスする工程、
体の血管系に器具を位置付ける工程、
超音波信号を体の血管系に送信するために該器具を使用する工程、
2〜20cm/秒の間の流速を示す血管からの反射超音波信号を受信するために該器具を用いる工程、
心臓の血管内電気活動を測定するために該器具を用いる工程、
一つ又は複数のパラメータとそれらの時間的挙動を、血流方向、血流速度(例えば、最も高い、最も低い、平均の速度)、血流特性パターン、圧力特性パターン、Aモード情報、流れの優先的な非ランダム方向、血管内心電図を特徴付ける種々の波形や群の形状(例えば、P波、QRS波、T波、ピークツーピーク振幅、絶対及び相対振幅変化、血管内ECGの他の独特な要素)の群から求めるために反射超音波と心電図信号を処理する工程、
一つ又は複数の予め決められたパラメータを用いて血管内で該器具を前進させる工程を有する。
患者の血管にアクセスできるように構成された細長いフレキシブルな部材と、
細長いフレキシブルな部材の末端に配置され、患者の血管と心臓の生体非結像超音波情報を提供するように構成されたセンサと、
細長いフレキシブルな部材の末端に配置され、患者の血管と心臓の生体電気信号(心電図)を提供するように構成されたセンサと、
生体の非結像超音波情報と、上記センサから提供された患者の血管と心臓の心電図情報を受信して処理し、また、患者の血管内と心臓内に細長いフレキシブルな部材の末端を配置するための位置情報を提供するように構成されたプロセッサと、
及び/又は、プロセッサからの位置情報を出力するように構成された出力装置のいずれかを含む。
センサで提供された患者の血管系の生体非結像超音波情報を処理して、出力情報に、視野内に構造と対象物を表示すること、
生体の非結像超音波情報と患者の血管系の心電図情報を処理して、出力情報に、患者の血管内の所望方向に関する細長いフレキシブルな部材の移動を示すこと、
静脈血流方向、静脈血流速度、静脈血流特性パターン、圧力特性パターン、Mモード情報及び優先的な非ランダム方向の流れ、心電図信号、P波パターンQRS群パターン、T波パターンからなる群から選択されたパラメータに基づいて、患者の血管系の生体非結像超音波情報を処理することのいずれかを含む。
体の血管にアクセスする工程、
体の血管内に器具を配置する工程、
体の静脈系に超音波信号を送信するために器具を使用する工程、
2〜20cm/秒の間の流れ速度を示す血管からの反射超音波信号を受信するために器具を使用する工程、
心臓の洞房結節の近傍を示す血管内心電図を記録するために器具を使用する工程、
静脈血流方向、静脈血流速度、静脈血流特性パターン、圧力特性パターン、Aモード情報及び優先的な非ランダム方向の流れ、心電図信号、P波パターン、QRS群パターン、T波パターンからなる群から一つ又は複数のパラメータを求めるために反射超音波信号と心電図を処理する工程、
及び、一つ又は複数の決定パラメータ又は血管内のパラメータを用いて血管内で器具を前進する工程、のいずれかを含む。
配置されようとしている器具を用いて体の血管内に向けて又はそこからAモード超音波信号を送信又は受信する工程、
体の血管に向けて又はそこからドップラー超音波信号を送信又は受信する工程、
体の血管に向けて又はそこから非結像ターゲット追跡用超音波信号を送信又は受信する工程、
器具を用いて体の血管から血管内及び心臓内の心電図を記録する工程、
反射超音波信号と血管内心電図を処理して流れパターンを求めると共に血管内で器具に向かう流れ方向を決定する工程、
反射超音波信号を処理して流れパターンを求めると共に血管内で器具から離れる流れ方向を決定する工程、
反射超音波信号と血管内心電図を処理して特定の血流パターンと特定の心電図パターンを示す信号の存在を求める工程、
反射超音波信号と血管内心電図を処理して洞房結合と洞房結節に対する器具の位置を求める工程、
反射超音波信号を処理して特定の構造(血液の凝集を含む)を示す信号の存在を判断する工程、
反射超音波信号と血管内心電図を処理して内頸静脈に対する器具の位置を求める工程、
反射超音波信号と血管内心電図を処理して鎖骨下静脈に対する器具の位置を求める工程、
器具で収集された情報を用いて、体の血管内の装置の位置を求めて固定する工程、
決められた場所に装置を維持するために体に該装置を固定する工程、
器具からの情報を用いて装置の現在の位置を計算する工程、
計算工程に基づいて、装置の計算された現在の位置と器具によって求めた位置を比較して、装置が器具によって決められた場所にあるか否かを判断する工程、
反射超音波信号と血管内ECGを処理して冠状静脈洞に対する右心房内の器具の位置を求める工程、
及び/又は、反射超音波信号と血管内ECGを処理して肺静脈に対する左心房内の器具の位置を求める工程のいずれかを含む。
本発明の実施例は、ガイド付血管アクセス装置からの信号を処理するガイド付血管アクセス装置とシステム、及び、処理装置からの出力に基づいてユーザに情報を提供するユーザインターフェイスを提供する。図1は、典型的な血管内アクセス及びガイダンスシステム100の一実施例を示す。システム100は、基端110と末端115を備えた細長い本体105を有する。細長い本体105は、患者1の血管系への挿入及び該血管系を進むように構成された種々の血管内装置の任意のものである。図1は、尺側皮静脈6に挿入された末端115を示している。この図示する実施例において予想される移動経路(点線20)は、心臓20の一部、又は、洞房結節(SAノード)8の近傍の上大静脈14内に入っている。大動脈3、肺動脈、肺静脈11、頸動脈10、腕頭静脈12、下大静脈16、及び房室結節(AVノード)9もまた、この図に示されている。
図2は、血管内装置150を示す。この装置は、基端110と末端115を備えた細長い本体105を有する。細長い本体105の上には非結像式超音波トランスデューサ(変換器)120が設けてある。無傷(組織を傷つけない)先端121が血管内装置150に設けてある。無傷先端121は、超音波レンズを備えていてもよい。超音波レンズは、超音波トランスデューサ120で生成される超音波信号の整形に利用できる。一つの形態では、超音波レンズは、発散レンズである。
[システム構成]
図6は、システム100を示す。システムは、非結像の超音波を利用した体の血流情報と電気活動を利用してカテーテルを案内するために利用される。一つの実施例では、システム100は、血管内装置150を、血流とECGパターンを利用して上大静脈14に配置し、血管内ECGを利用して洞房結節8に対して配置するために利用される。例示のディスプレイ140及び/又はユーザインターフェイスは、図7,8,9,13,14A,14Dに示してあり、以下に説明される。
一つの実施例では、本発明に係るシステムは、血管内における血管内装置150の場所を特定するために、センサを用いた血管内装置150で検出された2種類の生理学的パラメータを用いる。以下の実施例では、パラメータは超音波で特定された血流パターンと血管内心電図パターンである。図7,8,9は、血管内の異なる場所における血流と心電図パターンを示すディスプレイ130の図である。
a)例えば周波数領域のスペクトルパワーで測定された、双方向の流れのそれぞれの流れのエネルギーを比較すること、
b)洞房接合を検出するために、低周波領域における双方向の流れパターン、
c)心房の活動を検出するために拍動性、
d)速度プロファイル及び以下に説明するその他の最も高い意味のある平均速度である。
図13は、ここで説明する血管アクセス及びガイダンスシステム用のグラフィックユーザインターフェイス(GUI)として構成されたディスプレイ130の要素を示す。図13のディスプレイ130は、血管アクセス用にユーザフレンドリーな方法で異なるガイダンス技術(例えば、ドップラー、RCG、オーディオ、ワークフロー最適化、Aモード撮像)を一体化している。ドップラーウィンドウは、ドップラー又は相互相関法を用いて検出された血流の特性を示す。その情報は、時間又は周波数の領域に示される。双方向ドップラーの場合、2つの方向が一つのディスプレイ又は2つの異なるディスプレイに表示される。履歴を表示したり、テンプレートデータベースにアクセスさせるために、複数のドップラーウィンドウを並べてタブでアクセスするようにしてもよい。代わりに、履歴/テンプレートウィンドウは、器具スクリーン上に別々に表示してもよい。Aモード撮像ウィンドウは、時間(X軸)−深度(Y軸)のグラフに超音波情報を表示する。Aモード画像装置を保持する手の移動がリアルタイムに表れるように、ウィンドウは定期的に更新される。これにより、視覚と手の協調関係が増大する。典型的には、Aモードの単一ビームのオリジナルがスクリーンの上部にあり、Aモード超音波フラッシュライトが下を見ている。Aモード画像ディスプレイウィンドウの他の使用は、血液の凝固を撮影し識別できるようにすることである。ガイディングサインウィンドウは、異なる形状の色要素(点滅してもよい。)からなる。例えば、ドップラーウィンドウが赤の曲線よりも大きな曲線を表示する場合、ガイディングサインウィンドウが点灯してその他のライトが消灯される。血管内センサが誤った方向に配置されている場合、赤の光が点灯する(その他の光は消灯している)。信号が判断処理を行うために十分に強く/明るくないことを、黄色の光が示す。センサが洞房結節の血流特性を検出していることを、青色の光が示す。
図15は、カテーテルの例示的方法300を示す。この例では、方法300は、本発明で詳細に説明するシステムと処理技術によってもたらされる血流情報とECGを用いて提供されるガイダンス情報を利用する血管内装置を利用してユーザが如何にPICCカテーテルを配置するかを示す。この例は、説明の目的のためのものである。類似の従来のカテーテル、ガイドワイヤ、装置導入手順は、システムで生成された信号を利用した血管4中の装置の進行は、図16を参照して説明する。
Claims (38)
- 基端と末端を有する細長い本体と、
患者の血管の体内非結像超音波情報を提供するように構成された細長い本体に設けた非結像超音波トランスデューサと、
細長い本体が血管内にあるときに血管内心電図リード線電気検出セグメントが患者の生体心電図信号を提供する位置にある、細長い本体に設けた血管内心電図リード線と、
非結像超音波トランスデューサからの信号と血管内心電図リード線からの信号を受信して処理するように構成されたプロセッサと、
上記プロセッサで処理された情報の結果を表示するように構成された出力装置と、
心電図信号に応答して超音波トランスデューサを駆動するように構成された超音波トランスデューサに接続されたドライバとを備えた、血管アクセス及びガイダンスシステム。 - 上記出力装置は患者の血管内で上記細長い本体の一部に関連する結果を表示する、請求項1の血管アクセス及びガイダンスシステム。
- 上記プロセッサは、上記非結像超音波トランスデューサからの信号を処理し、上記非結像超音波トランスデューサの視野に構造の存在に関連した情報を上記出力装置に示すように構成されている、請求項1の血管アクセス及びガイダンスシステム。
- 上記プロセッサで処理された情報の結果は、生体の非結像超音波情報と生体の心電図情報に基づいて、血管内の細長い本体の位置又は移動の指標を含む、請求項1の血管アクセス及びガイダンスシステム。
- 上記プロセッサは、
静脈血流方向、静脈血流速度、静脈血流特性パターン、圧力特性パターン、Aモード情報、及び流れの優先的な非ランダム方向からなる群の少なくとも一つからの信号を有する非結像超音波トランスデューサからの信号を受信し処理し、また、心電図信号、P波パターン、QRS群パターン、T波パターン、EEG信号、及びEMG信号からなる群の少なくとも一つからなる、血管内心電図リード線からの信号を受信して処理するように、上記プロセッサが構成されている、請求項1の血管アクセス及びガイダンスシステム。 - 超音波トランスデューサに接続されたドライバは、複数の超音波送信モードで超音波トランスデューサを駆動するように構成されている、請求項1の血管アクセス及びガイダンスシステム。
- 血管内心電図リード線の末端側に配置された細長い本体上の第2の血管内心電図リード線を有し、上記プロセッサは第2の血管内心電図リード線からの信号を受信して処理するように構成されている、請求項1の血管アクセス及びガイダンスシステム。
- 上記プロセッサは、血管内心電図リード線からの信号と第2の血管内心電図リード線からの信号を比較するように構成されている、請求項7の血管アクセス及びガイダンスシステム。
- 血管内心電図リード線からの信号は目標の心電図信号を含み、第2の血管内心電図リード線は基準心電図信号を含む、請求項8の血管アクセス及びガイダンスシステム。
- 上記目標の心電図信号と上記基準心電図信号がECG、EMG、又はEEGに関連付けられる、請求項9の血管アクセス及びガイダンスシステム。
- 上記プロセッサは、非結像超音波トランスデューサから受信した信号と血管内心電図リード線から受信した信号を記憶するように構成されている、請求項1の血管アクセス及びガイダンスシステム。
- 上記プロセッサは、血管内心電図リード線から受信した信号に対応する非結像超音波トランスデューサから受信した記憶された信号の一部を処理するように構成されている、請求項11の血管アクセス及びガイダンスシステム。
- 血管内心電図リード線から受信した信号がP波を含む、請求項12の血管アクセス及びガイダンスシステム。
- 血管の生理学的パラメータを検出する別のセンサを有し、上記別のセンサは細長い本体に沿って配置されており、上記プロセッサは上記別のセンサからの信号を受信して処理するように構成されている、請求項1の血管アクセス及びガイダンスシステム。
- 血管の生理学的パラメータを検出する上記別のセンサは、圧力センサ又は光学センサである、請求項14の血管アクセス及びガイダンスシステム。
- 基端と末端を有する細長い本体と、
上記細長い本体上の非結像超音波トランスデューサと、
血管内装置が血管内にあるときに血管内心電図リード線が血液と接する位置にある上記細長い本体上の血管内心電図リード線と、
上記血管内装置が血管内にあるときに上記血管内心電図リード線が血液と接する位置にある上記細長い本体に設けた第2の血管内心電図リード線とを有し、
上記血管内心電図リード線が目標の上大静脈にあるときに上記第2の血管内心電図リード線が上大静脈の外側にあるように、上記第2の血管内心電図リード線の電気検出セグメントが上大静脈の長さに関連する距離の位置に配置されている、血管内装置。 - 上記血管内心電図リード線が、上記細長い本体の末端に配置されている、請求項16の血管内装置。
- 血管内心電図リード線の上記電気検出セグメントが非結像超音波トランスデューサの近傍に配置されている、請求項16の血管内装置。
- 上記第2の血管内心電図リード線の上記電気検出セグメントが上記血管内心電図リード線から所定距離の位置に配置されており、上記血管内心電図リード線が目標の心電図信号を検出しているとき、上記第2の血管内心電図リード線は基準心電図信号を検出する、請求項16の血管内装置。
- 上記血管内心電図リード線の電気検出セグメントが心臓からの目標血管内心電図信号を検出するように配置されているときに上記第2の血管内心電図リード線の電気検出セグメントが比較用の基準ECG信号を検出するように配置されるように、上記第2の血管内心電図リード線の電気検出セグメントが配置されている、請求項16の血管内装置。
- 上記血管内心電図リード線の電気検出セグメントが脳からの目標血管内心電図信号を検出するように配置されているときに上記血管内心電図リード線が比較用の基準EEG信号を検出するように配置されるように、上記第2の血管内心電図リード線の電気検出セグメントが配置されている、請求項16の血管内装置。
- 上記血管内心電図リード線の電気検出セグメントが筋肉からの目標血管内心電図信号を検出するように配置されているときに上記第2の血管内心電図リード線の電気検出セグメントが比較用の基準EMG信号を検出するように配置されるように、上記第2の血管内心電図リード線の電気検出セグメントが配置されている、請求項16の血管内装置。
- 上記血管内心電図リード線は、細長い本体内に収容された状態から上記細長い本体の外側に展開した状態に移動可能である、請求項16の血管内装置。
- 上記収容された状態の血管内心電図リード線は、血管内装置の末端を曲がる、請求項23の血管内装置。
- 上記血管内心電図リード線が収容された状態にあるとき、上記電気検出セグメントは心電図信号を検出するように配置されている、請求項23の血管内装置。
- 上記細長い本体の基端を方向付けるために上記血管内心電図リード線に接続された操縦要素を有する、請求項16の血管内装置。
- 上記操縦要素は、上記細長い本体の末端にトルクを与える、請求項26の血管内装置。
- 上記血管内心電図リード線は、使用時に、上記細長い本体の周りを少なくとも部分的に伸びる、請求項16の血管内装置。
- 上記血管内心電図リード線は、形状記憶合金から形成されている、請求項16の血管内装置。
- 上記血管内心電図リード線は、超音波センサを血管壁から離すために使用されるように構成されている、請求項16の血管内装置。
- 上記血管内装置は被覆された金属網状構造を有し、上記金属網状構造上の被覆の一部が除去されており、露出した金属網状構造は血管内心電図リード線電気検出セグメントとして機能する、請求項16の血管内装置。
- 上記血管内装置の末端に、組織に傷を付けない先端を有する、請求項16の血管内装置。
- 上記組織に傷を付けない先端は、超音波レンズを有する、請求項32の血管内装置。
- 上記超音波レンズは拡散レンズである、請求項33の血管内装置。
- 上記細長い本体に設けた開口と、上記開口と上記細長い本体の基端に接続された細長い本体内のルーメンを有する、請求項16の血管内装置。
- 生理学的パラメータを測定するために、上記血管内装置に設けた別のセンサを有し、
上記別のセンサが光学センサで、上記生理学的パラメータは、血管内で検出された光学特性に関連している、又は
上記別のセンサが圧力センサで、上記生理学的パラメータが、血管内部で取得された圧力測定値に関連している、若しくは、
上記別のセンサが音響センサで、上記生理学的パラメータが、血管内で検出された音響信号に関連している、請求項16の血管内装置。 - 上記細長いフレキシブルな部材がカテーテル、ガイドワイヤ又は探り針を有する、請求項16の血管内装置。
- 基端と末端を有する細長い本体と、
上記細長い本体上の非結像超音波トランスデューサと、
血管内装置が血管内にあるときに、血管内心電図リード線が血液と接する位置にある、
上記細長い本体上の血管内心電図リード線とを有し、
上記血管内心電図リード線は、超音波センサを血管壁から離すために使用されるように構成されている、血管内装置。
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2008
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- 2008-06-26 CA CA2691211A patent/CA2691211C/en active Active
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- 2008-06-26 CN CN2008801016368A patent/CN101854853B/zh active Active
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CA2691211A1 (en) | 2008-12-31 |
US20160143560A1 (en) | 2016-05-26 |
JP5963834B2 (ja) | 2016-08-03 |
CN101854853A (zh) | 2010-10-06 |
CN101854853B (zh) | 2013-11-06 |
JP2010532227A (ja) | 2010-10-07 |
US10470743B2 (en) | 2019-11-12 |
US20130289417A1 (en) | 2013-10-31 |
EP2170162A1 (en) | 2010-04-07 |
CA2691211C (en) | 2017-03-21 |
US20160228019A1 (en) | 2016-08-11 |
US20090177090A1 (en) | 2009-07-09 |
EP2170162B1 (en) | 2017-08-23 |
US10321890B2 (en) | 2019-06-18 |
WO2009003138A1 (en) | 2008-12-31 |
US20200077981A1 (en) | 2020-03-12 |
US20170035392A1 (en) | 2017-02-09 |
US8597193B2 (en) | 2013-12-03 |
JP2015091325A (ja) | 2015-05-14 |
US20090005675A1 (en) | 2009-01-01 |
US9339207B2 (en) | 2016-05-17 |
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