JP6183922B2 - バイオリズム障害の検出、診断、及び治療のためのシステム - Google Patents
バイオリズム障害の検出、診断、及び治療のためのシステム Download PDFInfo
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- JP6183922B2 JP6183922B2 JP2015076313A JP2015076313A JP6183922B2 JP 6183922 B2 JP6183922 B2 JP 6183922B2 JP 2015076313 A JP2015076313 A JP 2015076313A JP 2015076313 A JP2015076313 A JP 2015076313A JP 6183922 B2 JP6183922 B2 JP 6183922B2
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Description
本出願に記載された研究のいくつかは、国立衛生研究所からGrant R01 HL83359による資金援助を受けている。従って、米国政府は本発明に関して権利を有する。
本発明は一般的に医療の分野に関し、特に、バイオリズムの診断、バイオリズム障害の源の発見、バイオリズムの不規則性及びその他の障害の治療のための方法、システム、及び装置に関する。特に、本発明は、障害を検出し、診断し、治療する最小侵襲技術または外科技術に適用することができる。一の実施例は、心臓の鼓動の障害に本発明を適用し、別の実施例は、脳及び神経システムの電気的障害に適用し、その他の実施例は、胃腸システム及び泌尿生殖器システムの平滑筋の電気障害又は収縮障害に適用される。
a)一又はそれ以上のセンサを用いて複数個所における生物活性化信号を検出するステップと;
b)前記一またはそれ以上のセンサから、各信号についてのセンサ位置と各信号の活性化時間を含むデータを回収するステップと;
c)このデータを分析して前記バイオリズム障害の一またはそれ以上の原因の存在を認識し位置を突き止めるステップと;
を具える。
a)複数個所において生物活性化信号を検出するセンサ装置と;
b)前記センサ装置とインターフェースをとり当該装置から受信したデータを回収して処理するコンピュータプロセッサであって、前記回収したデータが各信号についてのセンサ位置と、各信号についての活性化時間または活性化期間を含むものであり、前記処理が、前記センサ位置において活性化開始時間を順序づけて前記バイオリズム障害の原因を示す活性化トレイルを作る処理を含む、コンピュータプロセッサと;
を具える。このオーダーを実行するアルゴリズムを含むソフトウエアも使用することができる。
a)一又はそれ以上のセンサを用いて複数個所における生物活性化信号を検出するステップと;
b)前記一またはそれ以上のセンサから、各信号についてのセンサ位置と各信号の活性化時間または活性化期間を含むデータを回収するステップと;
c)このデータを分析して前記バイオリズム障害の一またはそれ以上の原因の存在を認識し位置を突き止めるステップと;
d)前記バイオリズム障害の主原因を表示する前記原因のうちの一またはそれ以上を選択するステップと;
e)前記主原因を治療して前記バイオリズム障害を改善するあるいはなくすステップと;
を具える。
a)一又はそれ以上のセンサを用いて複数個所における生物活性化信号を検出するステップと;
b)前記一またはそれ以上のセンサから、各信号についてのセンサ位置と各信号の活性化時間を含むデータを回収するステップと;
c)このデータを分析して前記心拍障害の一またはそれ以上の原因の存在を認識し位置を突き止めるステップと;
を具える。
a)複数個所において生物活性化信号を検出するセンサ装置と;
b)前記センサ装置とインターフェースをとり当該装置から受信したデータを回収して処理するコンピュータプロセッサであって、前記回収したデータが各信号についてのセンサ位置と、各信号についての活性化時間または活性化期間を含むものであり、前記処理が、前記センサ位置において活性化開始時間を順序づけて前記心拍障害の原因を示す活性化トレイルを作る処理を含む、コンピュータプロセッサと;
を具える。このオーダーを実行するアルゴリズムを含むソフトウエアも使用することができる。
a)一又はそれ以上のセンサを用いて複数個所における生物活性化信号を検出するステップと;
b)前記一またはそれ以上のセンサから、各信号についてのセンサ位置と各信号の活性化時間または活性化期間を含むデータを回収するステップと;
c)このデータを分析して前記心拍障害の一またはそれ以上の原因の存在を認識し位置を突き止めるステップと;
d)前記バイオリズム障害の主原因を表示する前記原因のうちの一またはそれ以上を選択するステップと;
e)前記主原因を治療して前記心拍障害を改善するあるいはなくすステップと;
を具える。
a)第1及び第2の端部を有する筒状シャフト本体と;
b)前記本体の一方の端部に取り付けた拡長可能なセンサ構造であって、当該センサ構造が、複数のつながったセンサーアームであってねじれて動くと当該センサーアーム間のスペースが変化するセンサーアームを具え、前記センサ構造が少なくとも部分的に拡張したときに心室の管腔表面に接触できる、センサ構造と;
c)前記センサ構造を保持して送達する収縮シースと;
を具える。
a)第1及び第2の端部を有する筒状シャフト本体と;
b)直径方向に拡張可能ならせん状センサ構造であって、複数のセンサを具え、少なくとも部分的に拡張したときに心室の管腔表面に接触できるセンサ構造と;
c)前記センサ構造を保持して送達する収縮シースと;
を具える。
本発明の目的に照らして、以下の定義を適用すべきである:
検出/診断;リズム障害の検出と診断の用語は、本出願においては同じ意味で用いられる。
活性化時間;所定の心拍信号についての、活性化開始の時間。
活性化期間;所定の心拍の信号についての、活性化開始時間と終了時間の間の期間及び信号波形。心臓拡張インターバルは、前の心拍の活性化終了から現心拍の活性化開始までの期間である(図3)。
活性化トレイル;例えば、限定することなく、ロータを示すコア領域の周りの回転パターン、限局性拍動の原因を示すコア領域から半径方向に広がるパターン、あるいは分散パターンを含む識別できる信号パターンをつくるためのセンサ位置における活性化時間開始の順序付けであり、更なる信号サンプリングと上述の分析ステップの繰り返しを要する。
認識する及び位置を突き止める;心拍障害の局所的なあるいは分散した原因の存在を見つけ、次いでセンサ位置に対するあるいは心臓内の既知の身体構造位置に対するこの原因の位置を突き止めるプロセス。
心拍障害;異常な心拍であり、しばしば治療を必要とする。限定することなく、正常な洞結節の急速で異常な活性化(不適切な洞頻脈あるいは洞結節リエントリ)、心房頻脈(AT)、上室性頻脈(STV)、心房粗動(AFL)、心房性期外症候群/収縮(PAC)、及び心房細動(AF)の複雑なリズムなどの、心臓(心房)の上側室の急速な心拍、及び不規則な心房細動のある種の形を含む。急速な鼓動は、心臓の下側室(心室)にも生じる。これは、心室頻脈(VT)、心室粗動(VF)、心室頻拍、及び心室性期外症候群/収縮(PVC)を含む。心拍障害は、遅くなることもあり、洞性除脈、異所性心房除脈接合部性除脈、房室ブロック、心室固有調律を含む。
バイオリズム障害または心拍障害の原因;この用語は、本出願においては、バイオリズム障害又は心拍障害の「源」と同じ意味で使用される。これは、限定することなく、ロータを示すコア領域周囲の活性化シーケンスの回転パターン、限局性拍動の原因を示すコア領域からの半径方向に広がるパターン、あるいは、分散するパターンを意味する。本発明では、分散した原因が見つかった場合、信号サンプリングを追加の複数個所へ拡げて、本発明の検出及び分析ステップを繰り返す。これらの原因は、心拍障害の永続化に直接関与している。
センサ;この用語は、本出願では電極と同じ意味に用いられる。信号の検出と心臓から又は心臓への信号の伝送を行う装置を意味する。
図1は、本発明のプロセス及びシステムに使用することができる様々な有益な構成要素(モジュール)の概略図である。このモジュールは、互いに独立しており、共働してインターフェースをとってその機能を提供している、あるいは、プロセッサに含まれて互いに一体化しており、システムの個別ハードウエアユニットをより少ないものとしている。図1は、最小侵襲性経皮手順、あるいは表面ECG、心磁図、超音波、電磁放射、音波、マイクロ波、または電気インピーダンスの変化からの心エコー及び/又はドップラー検査、を行う間に障害の原因の位置を突き止めることができる一実施例を示す。
リアルタイムで、心拍障害をアブレーションまたは治療する手順を行う間に、手順の計画を立てる前に、あるいは、障害を再検討した後に、信号サンプリングを行うことができる。上述した通り、様々なタイプのセンサを用いて、一又はそれ以上の位置において器官から信号を回収する。接触センサは、組織とできる限り良好な接触を維持しなくてはならない。好ましいモードでは、電極は複数部位で同時にあるいはほぼ同時に記録するべきである。AFなどの最も速い心拍障害は、100msを超えるサイクル長を有し、この時間より実質的により少ない信号取得が、「ほぼ同時」に行われると考えられる。代替の操作モードによれば、センサをシーケンシャル部位に移動させることができる。本発明は、現存のセンサ装置と共に使用することができる。
分析における第1ステップは、図5に符号400−460で示すようなルックアップテーブルを用いて信号タイプを決定することである。このステップは、心臓(心臓病患者)、脳、呼吸器系、消化管、泌尿生殖器系、などから信号が立ち上がったかどうかを決定する。心臓病患者の場合、信号はECG表面、心内膜、心エコー、あるいはその他の信号である。心内膜の場合、信号は更に、活動電位(単相性活動電位)、バイポーラ電気記録図、ユニポーラ電気記録図、あるいはその他に分類される。これらの信号のいくつかは、高品質の情報(例えば、心臓内の単相性活動電位記録など)を提供するが、その他はしない。低品質の信号では、源の位置を特定するためには、事前処理、フィルタリング、平均化、異なる時間とその他のコンピュータ計算ステップにおけるその患者のデータベースに保存されている信号との比較、を必要とすることが多い。
の閉曲線上の線積分を計算することによって見つけることができる。ここで、この線積分は、位相特異点を囲む経路l上で行われる。電極からの信号は単一で観測可能であるため、位相の決定には、特別の注意が必要である。我々は、電極信号の品質に応じて、いくつかの異なる方法を用いる。
心拍障害の源についてのデータは、データベース160に保存することが好ましい。これは様々な患者の源を分類する、単一の患者の源を認識する、あるいは患者が同じあるいは異なる源に戻るかどうかを確認するのに有益である。データベース内のデータは、従って、同時に発生した源の数、レート、時間の経過に伴うレートの変化可能性、器官、その源によって活性化が直接生じている生体器官のサイズ(空間定数)、位置、この位置が時間の経過につれて移動するかどうか、源が検出された時間における心臓の複数領域なにおけるレート(AFの間の左右心房のレートなど)、及び各源のアブレーションに対する反応を含む、上述した特徴を含む。
本発明は、バイオリズム障害の特定、位置、及び上述した特徴を医師に通信する方法および装置を含む。これは、視覚表示手段、典型的には、コンピュータモニタ上の図形表示、あるいは心臓解剖に関連する源を示すプリントアウト、または、その源願ある位置及び/又はセンサ部位の基本的テキストライン概要を含む。
律動障害の原因を検出して診断するのに用いる本発明のプロセス及びシステムに加えて、本発明は、バイオリズム障害の源を治療して、この律動障害を修正、改善あるいはなくすデバイス及び方法を含む。
重要な動作モードでは、本発明を非リアルタイムの、オフライン分析態様で使用する。このレビューモードを、以前の電気生理学的研究といった時を改めた個人からのデータに、別のデバイス(埋め込んだペースメーカ、あるいは除細動器)または以前に失敗したアブレーションからのデータに、適用することができる。これを用いて、以前の手順からの結果をレビューしたり、本発明の適用を考える前の患者からのデータをレビューしたり、あるいは、同じ患者が、現在、律動障害について同じあるいは異なる源を提示しているかどうかを評価することができる。
図11、パネル900−910は、代表的な患者である、5年以上の持続性心房細動(AF)がある47歳の男性を示す。この患者は、心臓の症候性ペーシングが続いており、アミオダロンを使った様々な治療とその他の適切な治療の代わりに、また、AFの以前のアブレーション術にもかかわらず、病院の緊急ルームを訪れて治療を受ける必要があった。彼の症状の重大性を考え、この患者は更なる評価とアブレーションを行うために、電気生理学研究所に戻ることを選択した。
77歳の男性が、心房細動(AF)のアブレーションを示していた。彼の病歴は、複数の抗不整脈薬剤ではなく、発作性AFであり、若干肥大した左心房(直径45mm)と、正常な左心室駆出分画率(58%)に注目すべきであった。侵襲性の電気生理学的観察において、上述した通りカテーテルを心房に挿入した。本発明を、複数のセンサに適用した。図15、パネル900は、下側肺静脈近傍に電気ロータの形の局在化した源を示している。左から右へ(時間の経過に沿って)パネルを調べると、暖色(赤)で示す消極化した(活性化)組織が、左下側肺静脈の内側唇上のコア領域周囲に時計回り方向に展開していることを示している(黒いくびれた形のアウトライン参照)。この部位におけるアブレーションが、AFを即座に終結させた。
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Claims (27)
- 心拍障害の電気活性に関連する信号間の関係を決定するシステムにおいて:
電気活性に関連する複数の活性化信号であって、一またはそれ以上の位置における各活性化信号の位置及び活性化開始時間に関連するデータを具え、前記一またはそれ以上の位置における複数の活性化開始時間にアクセスするようにした活性化信号にアクセスし;
一またはそれ以上の位置における複数の活性化開始時間のシーケンスを構成し、前記活性化開始時間の順序づけに基づいて活性化トレイルを作成し;
前記活性化トレイルに関連する少なくとも一のおよそのコア領域を決定する;
ように構成したプロセッサを具え、前記活性化トレイルは回転パターンまたは半径方向に広がるパターンを含む識別可能な信号パターンであり、前記回転パターンは前記少なくとも一のおよそのコア領域の周りを回転し、前記半径方向に広がるパターンは前記少なくとも一のおよそのコア領域から広がることを特徴とするシステム。 - 請求項1に記載のシステムにおいて、前記プロセッサが更に、各位置における活性化開始時間のシーケンスを視覚的に表わして前記活性化トレイルを表示するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に、前記回転パターン又は前記半径方向に広がるパターンを視覚的に表示するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記およそのコア領域がロータであることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記回転パターンまたは前記半径方向に広がるパターンが時間的に繰り返されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に、少なくとも一のおよそのコア領域を視覚的に表示するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記少なくとも一のおよそのコア領域が限局性活性であることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に、活性化開始時間の分散パターンを決定することによって、前記シーケンスを構成するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に、追加の複数の位置を収集、配置、及び決定するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に前記活性化トレイルを視覚的に表示するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に信号ノイズをフィルタリングするように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に、前記活性化トレイルを、直接位相、Hilbert変換、及び前記信号に関連する時間ドメイン分析の一またはそれ以上の方法に基づいて認識するように構成したことを特徴とするシステム。
- 請求項1に記載のシステムにおいて、ある位置におけるある活性化信号の前記活性化開始時間に関連する活性化時間データが、更に、活性化開始時間とそれに対応する終了時間を含むことを特徴とするシステム。
- 請求項14に記載のシステムにおいて、前記活性化時間データが心臓拡張インターバルを含むことを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記データが複数位置において同時に生成された活性化信号に対応することを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記データが複数位置において段階的に生成された活性化信号に対応することを特徴とするシステム。
- 請求項16に記載のシステムにおいて、前記データが単一の位置からの活性化信号に対応することを特徴とするシステム。
- 請求項1に記載のシステムが更に、データベース中の前記活性化トレイルに関連するデータを保存することを特徴とするシステム。
- 請求項1に記載のシステムが更に、前記活性化トレイルを、データベースに保存されたデータに関連する同様の活性化トレイルとの比較に基づいて、増補または変更するステップを具えることを特徴とするシステム。
- 請求項1に記載のシステムが更に、複数位置の各々における電圧時間トレースの電気記録図を構築し、当該構築は、前記電気記録図に、前記データ中の各位置における各活性化信号の活性開始時間における生理学的パターンを挿入することによって行われることを特徴とするシステム。
- 請求項20に記載のシステムにおいて、前記生理学的パターンが、以前に記録したデータとシミュレーションしたパターンからなる群から選択されたパターンを具えることを特徴とするシステム。
- 請求項20に記載のシステムにおいて、前記生理学的パターンが、ユニポーラ電気記録図、バイポーラ電気記録図、活動電位の表示、あるいはこれらの組み合わせからなる群から選択されたパターンであることを特徴とするシステム。
- 請求項20に記載のシステムにおいて、前記生理学的パターンがレートによって調整されることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記プロセッサが更に、前記活性化トレイルに近い複数の位置の一またはそれ以上における前記活性化信号に対応するデータを分析するように構成されていることを特徴とするシステム。
- 請求項24に記載のシステムにおいて、前記データの分析が更に、レート、規則性、振幅、期間、及び位置の一つの分析を含むことを特徴とするシステム。
- 請求項24に記載のシステムにおいて、前記位置の数が、前記活性化トレイルを直接測定する分析に比較して低減されることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記電気的活性が、心臓、脳、中枢神経、末梢神経、骨格筋、平滑筋、消化管、膀胱及び子宮の一またはそれ以上に関連することを特徴とするシステム。
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