JP2007537840A - 埋込み可能心臓デバイスによるリモデリング制御治療と抗リモデリング治療との組合せ法 - Google Patents
埋込み可能心臓デバイスによるリモデリング制御治療と抗リモデリング治療との組合せ法 Download PDFInfo
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Abstract
Description
本出願は、2003年11月3日に出願された同時係属中で、かつ、同一譲受人に譲渡された米国特許出願第10/700,368号に関連し、その開示は、参照により組み込まれる。
心臓の選択された心腔に電気刺激を供給する埋込み可能心臓デバイスは、多くの心疾患を処置するために開発されてきた。たとえば、ペースメーカは、最も一般的には、心室レートが緩慢過ぎる徐脈の処置のために、調時されたペーシング・パルスによって心臓をペーシングするデバイスである。房室伝導欠陥(すなわち、AVブロック)や洞不全症候群は、永続的なペーシングの必要を示す徐脈の最も一般的な原因を表す。適切に機能する場合、ペースメーカは、代謝要求に適合するように心臓が適切な調律で自身をペーシングすることができないことを、最小心拍数を強制することによって補っている。また、埋込み可能デバイスは、抗頻脈ペーシングによるか、あるいは、心房または心室細動を終了させるための電気刺激の送出によって、速過ぎる心臓調律を処置するためにも使用される。
上述したように、自律神経系の活動は、MIの結果として、または、心不全によって起こる心室リモデリングに少なくとも部分的に起因する。リモデリングは、たとえば、ACE阻害剤やベータ遮断薬を使用した薬理学的介入によって影響を受ける可能性があることが実証された。しかし、薬理学的処置は、副作用のリスクを伴い、厳密に薬物の作用を調節することも難しい。本発明によれば、抗リモデリング治療またはARTと呼ばれる、電気刺激手段を使用して、自律神経活動が調節される。心室再同期ペーシングと共に送出されると、自律神経活動のこうした調節は、心臓リモデリングを逆転するか、または、防止するように相乗的に作用する。
図1に示すように、CRTを実施する埋込み可能心臓デバイス100は、通常、患者の胸部内の皮下または筋肉下に設置され、心房および/または心室を検知し、ぺーシングするのに使用される電極300にデバイスを接続するために、リード線200が、経静脈的に心臓内に通される。電極は、種々の手段によって、心外膜上に配置される。プログラム可能な電子コントローラによって、経過時間間隔と検知された電気活動(すなわち、ペーシング・パルスの結果としてではない内因性心拍動)に応答して、ペーシング・パルスが出力される。デバイスは、検知される心腔の付近に配設された内部電極を組み込んだ検知チャネルによって、内因性心臓の電気的活動を検知する。デバイスによって検出される心房または心室の内因性収縮に伴う脱分極波は、それぞれ、心房センスまたは心室センスと呼ばれる。内因性拍動のない状態でこうした収縮を引き起こすために、あるしきい値より大きいエネルギーを有するペーシング・パルスが、ペーシングされる心腔の付近に配設された内部電極を組み込んだペーシング・チャネルによって心腔に送出される。図には、神経刺激用の電極を組み込み、無線リンクを介してデバイス100と通信するサテライト・ユニット110も示される。
本発明の一実施形態では、RCTおよび/またはARTは、埋込み可能デバイスによって実施される心機能の評価に従って調整される。心臓機能が評価される1つの手段は、心拍出量を測定し、心拍出量を患者の測定された運動レベルと比較することによる。心拍出量は、インピーダンス技法によって測定されてもよく、インピーダンス技法において、経胸腔インピーダンスが測定され、1回拍出量を計算するのに使用される。一実施形態では、運動レベル・センサは、励起器とインピーダンス測定回路を含む分時換気量センサである。励起器は、胸腔内に配設される励起電極に指定された振幅の励起電流(たとえば、一定振幅のパルス波)を供給する。励起電流が供給されている間、電極間の電位差が、電圧センス電極間で経胸腔インピーダンスを表すように、電圧センス電極は、胸腔の選択された領域内に配設される。導電性ハウジングまたは筐体は、電圧センス電極のうちの1つの電極として使用される。インピーダンス測定回路は、電圧センス電極からの電圧センス信号を処理して、インピーダンス信号が導出される。インピーダンス信号のさらなる処理は、胸腔内での電圧センス電極のロケーションに応じて、呼吸活動および/または心臓血液容積を表す信号の導出を可能にする。(たとえば、本発明の譲受人に譲渡され、参照により組み込まれる米国特許第5,190,035号と第6,161,042号を参照されたい)呼吸成分を除去するために、インピーダンス信号がフィルタリングされると、結果として、任意の時点における心臓内の血液容積を表す信号が得られ、したがって、1回拍出量の計算が可能となり、心拍数と組み合わされて、心拍出量の計算が可能になる。所定期間にわたって積分された(または、平均され、心拍数を掛けた)1回拍出量は、患者の心拍出量を与える。ルックアップ・テーブルまたは他の機能を使用して、所与の運動レベルについて、どれだけの心拍出量が適切であると考えられるかが計算できる。心拍出量の測定または心拍出量の適切性の判定は、RCTおよび/またはARTの送出を調節するために、デバイスによって使用されてもよい。
本発明の例示的な実施形態では、MI後患者に心臓治療を施す埋込み可能デバイスは、ペーシング・パルスを1つまたは複数の心室部位に送出する1つまたは複数のペーシング・チャネルと、交感神経活動を抑制する神経を刺激する交感抑制チャネルとを含む。コントローラは、収縮期中に、機械的に心室心筋の領域の負荷を取り除くために、その領域を前興奮させる心臓再同期モードにおいて心室ペーシングを送出することによるリモデリング制御治療(RCT)を行うようにプログラムされる。心臓再同期治療は、プログラム式2心室オフセット間隔によって決められるように、心室の一方の心室が、他の心室に対して前興奮させられる2心室ペーシングとして行われてもよい。あるいは、左心室の遅延活性化を患う患者では、左心室のみの再同期ペーシング・モードが採用されてもよい。別の実施形態では、ペーシング治療は、心室のうちの少なくとも1つの心室が、複数部位でペーシングされて、部位のうちの1つまたは複数の部位を他の部位に対して前興奮させる多部位心室ペーシングとして送出されてもよい。いずれの場合も、心室ペーシングは、心室補充収縮間隔が、心室ペース間で規定される非心房トラッキング・モードか、または、心室ペースが、心房センスに続く規定された房室補充収縮間隔後に送出される心房トラッキング・モードで送出されてもよい。変時的に不全である患者では、心房ペーシング・チャネルはまた、心房をペーシングするために提供されてもよく、心室ペース(複数可)は、心房ペースに続く房室補充収縮間隔の終了によって送出される。
Claims (32)
- 心臓治療を患者に施す埋込み可能デバイスであって、
ペーシング・パルスを1つまたは複数の心室部位に送出する1つまたは複数のペーシング・チャネルと、
交感神経活動を抑制する神経を刺激する交感抑制チャネルと、
プログラムされたペーシング・モードに従った、心周期中の1つまたは複数の心室部位に対するペーシング・パルスの前記送出を制御するコントローラとを備え、
前記コントローラは、収縮期中に、機械的に心室心筋の領域の負荷を取り除くように、リモデリング制御治療(RCT)のために前記領域を前興奮させるように心室ペーシングを送出するようにプログラムされ、
前記コントローラは、RCTと共に、前記交感抑制チャネルを介して交感神経活動を抑制することによる抗リモデリング治療(ART)のためにさらにプログラムされるデバイス。 - 副交感神経活動を刺激する副交感刺激チャネルをさらに備え、前記コントローラによって行われた前記抗リモデリング治療が副交感神経活動の刺激をさらに含む請求項1に記載のデバイス。
- 前記副交感刺激チャネルは、神経刺激パルスを出力するパルス発生器と、副交感神経の周りへの配設に適合した神経カフ電極とを含む請求項2に記載のデバイス。
- 前記交感抑制チャネルは、神経刺激パルスを出力するパルス発生器と、動脈圧受容器近くへの配設に適合した電極とを含む請求項1に記載のデバイス。
- 前記交感抑制チャネルは、圧反射刺激を肺動脈内の圧受容器部位に加える手段を含む請求項4に記載のデバイス。
- 前記交感抑制チャネルは、圧反射刺激を心臓脂肪パッド内の神経終末に加える手段を含む請求項4に記載のデバイス。
- 前記交感抑制チャネルは、圧反射刺激を求心性神経に加える手段を含む請求項4に記載のデバイス。
- 前記副交感刺激チャネルは、神経刺激パルスを出力するパルス発生器と、血管に隣接する副交感神経を経脈管的に刺激するように、脈管内配設に適合した電極とを含む請求項2に記載のデバイス。
- 前記電極とパルス発生器は、無線受信機を含むサテライト・ユニット内に組み込まれ、無線リンクを介して前記サテライト・ユニットの動作を制御する前記コントローラにインタフェースされた無線送信機をさらに備える請求項2に記載のデバイス。
- 前記電極とパルス発生器は、RF受信機を含むサテライト・ユニット内に組み込まれ、RFリンクを介して前記サテライト・ユニットの動作を制御する前記コントローラにインタフェースされたRF送信機をさらに備える請求項2に記載のデバイス。
- 前記コントローラは、RCTとARTを同時に送出するようにプログラムされる請求項1に記載のデバイス。
- 前記コントローラは、RCTとARTを、プログラムされた時間間隔で別々に実施するようにプログラムされる請求項1に記載のデバイス。
- 心機能を評価する手段をさらに備え、前記コントローラは、心機能の評価によって調節されたRCTとARTを実施するようにプログラムされる請求項2に記載のデバイス。
- 前記コントローラは、心機能の前記評価に従って、副交感刺激と交感抑制の実施を別々に調節するようにさらにプログラムされる請求項13に記載のデバイス。
- 前記心機能評価手段は、心拍出量を測定するセンサを備え、前記コントローラは、前記測定された心拍出量に従って、RCTとARTの実施を調節するようにプログラムされる請求項13に記載のデバイス。
- 前記心拍出量センサは、経胸腔インピーダンス測定回路である請求項15に記載のデバイス。
- 前記心機能評価手段は、動脈血圧センサを備え、前記コントローラは、前記測定された血圧に従って、RCTとARTの実施を調節するようにプログラムされる請求項13に記載のデバイス。
- 前記心機能評価手段は、前記患者の運動レベルを測定する運動レベル・センサを備え、前記コントローラは、前記測定された運動レベルに従って、RCTとARTの実施を調節するようにプログラムされる請求項13に記載のデバイス。
- 前記運動レベル・センサは、分時換気量を測定する請求項18に記載のデバイス。
- 前記心機能評価手段は、自律神経平衡を測定する検知チャネルを含み、前記心機能評価は、前記患者の自律神経平衡の評価を含む請求項13に記載のデバイス。
- BB間隔と呼ばれる、連続する内因性拍動間の時間間隔を測定し、収集し、前記収集された間隔を離散BB間隔信号として記憶し、規定の高周波数帯域と低周波数帯域になるように前記BB間隔信号をフィルタリングし、LFおよびHFと呼ばれる、前記低周波数帯域と前記高周波数帯域のそれぞれにおいて、前記BB間隔信号の信号パワーを確定する回路と、
LF/HF比を計算し、前記LF/HF比を指定されたしきい値と比較することによって、自律神経平衡を評価する回路とをさらに備える請求項20に記載のデバイス。 - 自律神経平衡を測定する前記検知チャネルは、交感神経と副交感神経における電気活動を測定する請求項20に記載のデバイス。
- RCTは、心室ペーシング部位に供給される前興奮の程度を変えることによる、心機能の前記評価に応答して調節される請求項13に記載のデバイス。
- ARTは、神経刺激パルスの振幅を変えることによる、心機能の前記評価に応答して調節される請求項13に記載のデバイス。
- ARTは、神経刺激パルスの周波数を変えることによる、心機能の前記評価に応答して調節される請求項13に記載のデバイス。
- ARTは、神経刺激パルスのデューティ・サイクルを変えることによる、心機能の前記評価に応答して調節される請求項13に記載のデバイス。
- 内因性心臓活動を検出する検知チャネルと、
カーディオバージョン/ディフィブリレーション・ショック・パルスを送出するショック・チャネルとをさらに備え、
前記コントローラは、指定されたレートしきい値を超える頻脈性不整脈の検出に基づいてショック・パルスを送出するようにプログラムされる請求項1に記載のデバイス。 - 前記コントローラは、2心室ペーシングとしてRCTを送出して、前記心室のうちの一方の心室を、他の心室に対して前興奮させるようにプログラムされる請求項1に記載のデバイス。
- 前記コントローラは、前記心室のうちの少なくとも一方が、複数の部位でペーシングされる多部位心室ペーシングとしてRCTを送出して、前記部位の1つまたは複数の部位を他の部位に対して前興奮させるようにプログラムされる請求項1に記載のデバイス。
- 前記コントローラは、収縮期中に、前記左心室を前記右心室に対して前興奮させる左心室のみペーシングとしてRCTを送出するようにプログラムされる請求項1に記載のデバイス。
- 心機能の前記評価は、RFテレメトリ・リンクを介して遠隔モニタに送信される請求項1に記載のデバイス。
- 前記コントローラは、前記RFテレメトリ・リンクを介して前記遠隔モニタから受信された通信に応答してRCTとARTの実施を修正するようにプログラムされる請求項31に記載のデバイス。
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US10/850,341 US7260431B2 (en) | 2004-05-20 | 2004-05-20 | Combined remodeling control therapy and anti-remodeling therapy by implantable cardiac device |
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PCT/US2005/017659 WO2005113066A1 (en) | 2004-05-20 | 2005-05-20 | Combined remodeling control therapy and anti-remodeling therapy by implantable cardiac device |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1761305A1 (en) | 2007-03-14 |
JP4731559B2 (ja) | 2011-07-27 |
US20050261741A1 (en) | 2005-11-24 |
EP1761305B1 (en) | 2010-08-11 |
US7260431B2 (en) | 2007-08-21 |
US20110015692A1 (en) | 2011-01-20 |
US8838239B2 (en) | 2014-09-16 |
US20130296958A1 (en) | 2013-11-07 |
WO2005113066A1 (en) | 2005-12-01 |
DE602005022865D1 (de) | 2010-09-23 |
US8483828B2 (en) | 2013-07-09 |
ATE477015T1 (de) | 2010-08-15 |
US7805193B2 (en) | 2010-09-28 |
US20080015648A1 (en) | 2008-01-17 |
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