JP5027797B2 - 心臓再同期化のための多重電極ペーシングの自動最適化 - Google Patents
心臓再同期化のための多重電極ペーシングの自動最適化 Download PDFInfo
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Description
本願は、35U.S.C.§119(e)に基づいて、米国仮特許出願第60/667,575号(2005年3月31日出願)、米国仮特許出願第60/667,529号(2005年3月31日出願)米国仮特許出願第60/684,751号(2005年5月25日出願)米国仮特許出願第60/695,577号(2005年6月29日出願)の出願日の優先権を主張する。上記出願の開示は、本願明細書において参考により援用される。
(発明の分野)
本発明は生体組織における電気信号の監視と管理に関する。特に、本発明は心臓再同期療法のための多電極ペースメーカーを自動的に最適化するための方法とシステムに関する。
心臓再同期療法(CRT)は、うっ血性心不全に苦しむ患者のための重要で新しい医学的介入である。うっ血性心不全においては、身体の生理的欲求を満たすために血液を供給するような機械ポンプとして、心臓が十分に機能できなくなることにより症状が進行する。うっ血性心不全は、心機能の緩やかな低下によって典型的に特徴付けられ、最終的に死をもたらす重篤な悪化が時々起こる。米国において500万を超す患者がこの疾患に苦しんでいると推定されている。
本発明の一つの実施形態は、多電極ペースメーカーリードを用いるCRT手技を自動的に最適化するためのシステムを提供する。操作中、このシステムは、患者に挿入される一つ以上のペースメーカーリード上の一つ以上のサテライトを選択するために、第一の反復を行う。一つのペースメーカーリードは複数のペースメーカーサテライトを含み、一つのペースメーカーサテライトは個別にアドレス指定が可能で、かつ電気信号の通信または検出が可能な複数の電極を含む。次にシステムは、選択されたサテライト上の一つ以上の電極を選択するための第二の反復を行う。システムはさらに、一つ以上の選択された電極を介して送信されるペーシング信号のための一つ以上のタイミング設定を選択するために、第三の反復を行う。
以下の説明は、全ての当業者が本発明を作成し使用できるようにするために提示され、特定の応用の文脈とその必要条件において提供される。開示される実施形態に対する様々な修正は、当業者には容易に理解できるものであり、本書で定義される一般原則は本発明の精神と範囲から逸脱することなしに他の実施形態や応用に適用されてもよい。従って、本発明は示される実施形態に限定されることを意図するものではないが、本書で開示される原則と特徴に一致する最大の範囲に合致するものである。
(多電極ペースメーカーリード)
図1は、本発明の実施形態に従って、多電極ペースメーカーリードに内蔵される多数のペースメーカーサテライトの場所を図示する。ペーシングおよび信号検出システム101は、心臓外伝達と制御要素を総合システムに提供する。いくつかの実施形態では、ペーシングおよび信号検出システム101は、例えば外部または体外部位に存在するペースメーカーの容器であってもよい。
多電極リードはペーシングの目的に多数の電極の組み合わせを提供することができるため、迅速に効率的な組み合わせを特定することは非常に有利である。理論上、システムは、総当り方式で可能性のある全ての電極の組み合わせとタイミング設定を自動的に試すことができるが、時間がかかる。本発明の実施形態は、最適化プロセスを迅速化するために三段階の階層反復を用いる。そのようなプロセスを用いて、心臓応答を効率的に生成できないサテライトと電極の組み合わせを、システムは迅速に除外できる。
典型的には、システムは多電極ペースメーカーリードを制御するために様々なハードウェアとミドルウェアモジュールを使用する。自動最適化処理を行うために、これらのモジュールは、応答データが同時に収集される間、与えられたシーケンスにおいて異なるパラメータを用いて稼動される。そのようなシステムを実行するための一つの可能性のある手法は、システムにおいて使用される特定のハードウェアのために作られる、カスタム化された組み込みソフトを開発することである。しかしそのようなシステムは費用がかかり柔軟性に欠けたりするが、これは制御ソフトウエアが基礎をなすハードウェアとミドルウェアに密接に接続され、簡単に変更できないためである。
本発明の実施形態は、同期性情報を測定、表示するための多数の方法を提供する。本書で説明する同期性の表示の様々な方法は、臨床医が同期性をリアルタイムかつ直観的な様式で観察できるようにする。さらに臨床医の入力は、例えば広域ピークの選択などにおいて最適化プロセスを支援することができる。
本発明の実施形態は、臨床医が応答信号を観察して最適化プロセスを手助けできるように、同期性情報を表示または示すために多数の方法を用いる。
図13は、本発明の実施形態に従う、同期性指数の直線表示の典型的な図である。この表示は、縦棒に沿って表示1308の位置を変えることにより、対応する2つの信号のポイントの間のタイミング遅延を示す。縦棒は、1302、1304、および1306の3つの領域を含む。領域1306は0と60ミリ秒の間のタイミング遅延用、領域1304は60と120ミリ秒の間の遅延用、ならびに領域1302は120ミリ秒より長い遅延用である。例えば60ミリ秒と120ミリ秒などの数値域は単に図示の目的のためのものである。他の範囲もまた使用できる。一つの実施形態では、領域1302、1304、および1306は色分けできる。例えば、領域1206は「良好」な同期性を示すために緑、領域1304は「可」の同期性を示すために黄色、そして領域1302は「不良」な同期性を示すために赤であってもよい。表示矢印1308はリアルタイムで動かして現行で測定されている値を示すことができる。読み取り値1310はタイミング遅延の数値を示す。
本発明の実施形態は、心臓の同期性を評価するためにECG信号とセンサー信号の間の電気機械的遅延(EMD)を測定する。一般に、電気的活動の開始と応答する機械的事象の開始の間には有限の時間が存在する。この時間がEMDとされる。EMDは心臓内の同期性の程度を示すために使用できる。
図23は、本発明の実施形態に従って、多電極ペースメーカーリードを設定するため、ならびに測定された信号を表示するための典型的なグラフィカルユーザインターフェース(GUI)を図示する。電極を設定するため、複数電極リード2354から送信されるペーシング信号を調節するために、このGUIを使用できる。ユーザーは、キーボード、マウス、またはタッチスクリーンを用いて、このGUIを介してペーシング制御システムを操作できる。このGUIはまた、最適化されるべき異なる同期不全および性能指数をユーザーが選択し観察できるようにする。
Claims (36)
- 心臓再同期療法(CRT)の自動最適化を行うためのシステムであって、
前記システムは、
患者に挿入される一つ以上のペーシングリード上の一つ以上のサテライトを選択するための第一の反復を行う手段であって、ペーシングリードは、複数のペーシングサテライトを含み、ペーシングサテライトは、個別にアドレス指定が可能な複数の電極であって、電気信号の送信または検出のために使用可能である複数の電極を含む、手段と、
前記選択されたサテライト上の一つ以上の電極を選択するための第二の反復を行う手段と、
前記選択された電極のうちの一つ以上の電極を介して送信されるペーシング信号についての一つ以上のタイミング設定を選択するための第三の反復を行う手段と、
を含む、システム。 - 前記ペーシングリードは、一つ以上のセンサーをさらに含む、請求項1のシステム。
- 前記センサーは、加速度計、ひずみゲージ、角度計、圧力センサー、温度センサー、または電場によって誘起される信号を検出するように構成された電極であり得る、請求項2のシステム。
- 前記第一の反復を行なう手段は、
前記ペーシングサテライトを介してペーシング信号を反復して送信する手段であって、各反復は、前回の反復とは少なくとも一つの異なるサテライトを含む、手段と、
前記サテライトを介して送信される前記ペーシング信号によってもたらされる心臓応答に基づいて、前記一つ以上のサテライトを選択する手段と、
を含む、請求項1のシステム。 - 前記サテライトを介して前記ペーシング信号を送信する手段は、
少なくとも一つのサテライトまたは一つの容器を信号発信源として使用し、
少なくとも一つのサテライトまたは前記容器を信号シンクとして使用する、請求項4のシステム。 - 前記サテライトを介して前記ペーシング信号を送信する手段は、送信用に前記サテライト上の全ての電極を使用する、請求項4のシステム。
- 前記心臓応答に基づいて前記一つ以上のサテライトを選択する手段は、前記ペーシング信号が心収縮をもたらすかどうかを判断する手段を含む、請求項4のシステム。
- 前記第二の反復を行う手段は、
前記選択されたサテライト上の前記電極を介してペーシング信号を反復して送信する手段であって、各反復は、前回の反復とは異なる電極を含む、手段と、
前記電極を介して送信された前記ペーシング信号によってもたらされる心臓応答に基づいて、前記一つ以上の電極を選択する手段と、
を含む、請求項1のシステム。 - 前記電極を介して前記ペーシング信号を送信する手段は、
前記選択されたサテライトのうちの一つのサテライト上の少なくとも一つの電極、または一つの容器を信号発信源として使用し、
前記選択されたサテライトのうちの一つのサテライト上の少なくとも一つの電極、または前記容器を信号シンクとして使用する、請求項8のシステム。 - 前記心臓応答に基づいて一つ以上の電極を選択する手段は、前記電極であって、該電極を介して心収縮をもたらすペーシング信号が送信される電極を選択する手段を含む、請求項8のシステム。
- 前記第三の反復を行う手段は、
少なくとも一つの選択された電極を介してペーシング信号を反復して送信する手段であって、各反復は、前回の反復とは前記ペーシング信号の異なるタイミング設定を含む、手段と、
前記ペーシング信号によってもたらされる心臓応答に基づいて一つ以上のペーシング信号のタイミング設定を選択する手段と、
を含む、請求項1のシステム。 - 前記選択された電極を介して前記ペーシング信号を反復して送信する手段は、
第一の場所で第一の選択された電極を介して第一のパルスを送信する手段と、
第二の場所で第二の選択された電極を介して第二のパルスを送信する手段と、
を含み、
前記ペーシング信号の前記タイミング設定は、前記第一のパルスと前記第二のパルスとの間の時間遅延を含む、請求項11のシステム。 - 前記選択された電極を介してペーシング信号を反復して送信する手段は、粗粒性反復と細粒性反復を実行する手段を含み、
前記粗粒性反復の間の前記タイミング設定の差は、前記細粒性反復の間の前記タイミング設定の差よりも大きい、請求項11のシステム。 - 前記粗粒性反復の間の前記タイミング設定の差は、前記細粒性反復の間の前記タイミング設定の差のおよそ5〜10倍である、請求項13のシステム。
- 前記粗粒性反復の間の前記タイミング設定の差は、前記細粒性反復の間の前記タイミング設定の差の少なくとも2倍である、請求項14のシステム。
- 前記粗粒性反復の間の前記タイミング設定の差は、前記細粒性反復の間の前記タイミング設定の差のおよそ5〜10倍である、請求項15のシステム。
- 前記粗粒性反復の間の前記タイミング設定の差は、約5〜10ミリ秒であり、
前記細粒性反復の間の前記タイミング設定の差は、約1ミリ秒である、請求項16のシステム。 - 前記心臓応答に基づいて前記ペーシング信号のタイミング設定を選択する手段は、
前記ペーシング信号のタイミング設定に対応する同期性を測定する手段を含み、
前記ペーシング信号のタイミング設定を選択する手段は、前記粗粒性反復の後において、他のタイミング設定より優れた同期性を生成するタイミング設定の収集を決定する手段をさらに含み、
前記細粒性反復は、前記粗粒性反復の後に決定された前記タイミング設定の収集に基づいて、行われる、請求項13のシステム。 - 前記タイミング設定の収集を決定する手段は、同期性対タイミングプロットに基づいて広域ピークを識別する手段を含む、請求項18のシステム。
- 前記タイミング設定の収集を決定する手段は、既定の閾値に基づいて前記タイミング設定を分類する手段を含む、請求項18のシステム。
- 前記同期性を測定する手段は、2つの対応する場所での心収縮を示す2つの応答信号間の時間差を測定する手段を含む、請求項18のシステム。
- 前記2つの応答信号間の時間差を測定する手段は、前記2つの信号の対応する最高スキューレートポイントを比較する手段を含み、それにより、前記2つの信号の相対値が使用可能になる、請求項21のシステム。
- 前記同期性を測定する手段は、2つの対応する場所での心収縮を示す2つの応答信号の相互相関を計算する手段を含む、請求項18のシステム。
- 前記同期性を測定する手段は、2つの対応する場所での心収縮を示す2つの応答信号の電気機械的遅延を比較する手段を含む、請求項18のシステム。
- 前記信号の電気機械的遅延は、心電図(ECG)の特徴点と信号の特徴点との間の時間遅延である、請求項24のシステム。
- 前記ECGの前記特徴点は、QRS群の開始点であり、
前記信号の前記特徴点は、前記信号の対応するピークである、請求項25のシステム。 - 前記ペーシング信号のタイミング設定を選択する手段は、前記タイミング設定に対応する前記同期性の図であって、医師が観察できる図を表示する手段を含む、請求項18のシステム。
- 前記同期性の図を表示する手段は、リアルタイムでX−Y座標面上にポイントをトレースする手段を含み、
前記ポイントのX座標は、第一の場所での心収縮を示す第一の応答信号の振幅に対応する値を示し、
前記ポイントのY座標は、第二の場所での心収縮を示す第二の応答信号の振幅に対応する値を示す、請求項27のシステム。 - 前記同期性の図を表示する手段は、
極座標上の第一のポイントをトレースする手段であって、前記第一のポイントの動径座標は、第一の場所での心収縮を示す第一の信号の振幅に対応する値を示し、前記第一のポイントの角座標は、一定速度にて変化するように構成されている、手段と、
同一極座標上で第二のポイントをトレースする手段であって、前記第二のポイントの動径座標は、第二の場所での心収縮を示す第二の信号の振幅に対応する値を示し、前記第二のポイントの角座標は、同一一定速度にて変化するように構成されている、手段と、
前記第一のポイントと前記第二のポイントの両方のトレースによって囲まれる領域をハイライトする手段と、
を含む、請求項27のシステム。 - スクリプト言語を使用することにより前記3セットの反復を自動的に実行する手段をさらに含む、請求項1のシステム。
- スクリプト言語を用いる各セットの反復中に応答信号の値を保存する手段をさらに含む、請求項30のシステム。
- スクリプト言語を用いて前記保存された値を読み込む手段をさらに含む、請求項30のシステム。
- スクリプト言語を用いて、サテライト、電極およびタイミング設定を保存する手段をさらに含む、請求項30のシステム。
- スクリプト言語を用いて、前記保存されたサテライト、電極およびタイミング設定を読み込む手段をさらに含む、請求項33のシステム。
- サテライト、電極およびタイミング設定を特定することによって、医師にペーシング手順を作成させる手段をさらに含む、請求項30のシステム。
- 前記医師にペーシング手順を作成させる手段は、前記ペーシング手順を自動的に実行するスクリプトを生成する手段を含む、請求項35のシステム。
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US8036743B2 (en) | 2011-10-11 |
EP1871470A4 (en) | 2011-06-01 |
WO2006105474A3 (en) | 2007-10-04 |
US20080294218A1 (en) | 2008-11-27 |
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