JP4689612B2 - 要求ベースの心機能治療 - Google Patents
要求ベースの心機能治療 Download PDFInfo
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- JP4689612B2 JP4689612B2 JP2006528133A JP2006528133A JP4689612B2 JP 4689612 B2 JP4689612 B2 JP 4689612B2 JP 2006528133 A JP2006528133 A JP 2006528133A JP 2006528133 A JP2006528133 A JP 2006528133A JP 4689612 B2 JP4689612 B2 JP 4689612B2
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- cardiac function
- patient
- cardiac
- therapy
- pacing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
- A61N1/36521—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure the parameter being derived from measurement of an electrical impedance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
- A61N1/36842—Multi-site stimulation in the same chamber
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
- A61N1/36843—Bi-ventricular stimulation
Description
心機能を改善するための電気刺激療法の一例は、CRTである。心室再同期療法では、心室を2つ以上の部位でペーシングして、興奮の広がりに影響を与え、より協調した収縮をもたらし、それによって心室間または心室内の伝導異常を克服する。両室ペーシングは、両室をペーシングしてそれぞれの収縮を同期化する再同期療法の一例である。再同期療法は、1つの室だけに複数部位のペーシング与えることも含む。たとえば、1つの心室の複数の部位を興奮性刺激パルスでペーシングして、ペーシング部位から出る複数の脱分極波を生成させる。それによって、より協調した心室の収縮をもたらし、存在する可能性がある心室内の状態の異常を補うことができる。
埋め込み型心臓機器は、通常、患者の胸の皮下または筋下に配置され、リードが静脈内を縫うように通って心臓内に入り、機器を電極に接続する。電極は、感知と刺激に使用される。様々な手段によって、リードを心外膜上に配置することもできる。プログラム可能な電子コントローラは、時間間隔の経過と感知された電気活動(すなわち、刺激パルスの結果として生じたのではない固有の心拍)に呼応して、出力すべき刺激パルスを発生する。機器は、感知すべき室付近に配置された内部電極によって、固有の心臓電気活動を感知する。機器によって感知された心房または心室の固有の収縮と関連した脱分極波は、それぞれ心房センスまたは心室センスと呼ばれる。固有の拍動が存在しない場合にこうした収縮を起こすために、一定の閾値を超えるエネルギーを有する刺激パルス(別名、一定リズムを確保するために送出されるペースまたはペーシング・パルス)が室に送出される。
心機能治療を要求ベースで提供するため、埋め込み型心臓機器のコントローラを、心機能治療の提供を一時停止し、1つまたは複数の感知モダリティによって患者の心機能を評価するようにプログラミングする。次いで判定アルゴリズムを使用して、その後の治療を決定する。一実施形態では、バイナリ判定アルゴリズムによって、心機能の評価に基づいて心機能治療を継続し、または無期限に中止する。たとえば、ストレス低減治療を心不全または心筋梗塞後の患者に使用して、心臓リモデリングの逆転を行うことができる。心機能の評価で、患者の状態が変わらない、または悪化したことが示された場合、機器はストレス低減治療を再開する。他方で、患者の心機能が十分に改善された場合は、機器は無期限に治療を終了する。心臓再同期治療の提供を心機能の評価に基づいて同様に継続し、または終了することができる。心機能治療の終了後に、定期的に、または他の方法で、機器が患者の心機能の監視を継続して、必要に応じて治療を再開することができる。また、機器が定期的に治療をスイッチ・オンして、患者の状態が徐々に進行したかどうか、また治療の提供が再び必要であるかどうかを判断する。
心機能を評価することができる一方法は、心拍出量を測定し、それを患者の測定済み運動レベルと比較することによる。上記のように、経胸インピーダンスを測定し使用して1回拍出量を計算するインピーダンス方式によって、心拍出量を測定することができる。長期にわたり積分した(または平均して心拍数を掛け算した)1回拍出量は患者の心拍出量である。参照テーブルまたは一次関数を使用して、所与の運動レベルに十分であると考えられる心拍出量を計算することができる。機器は、こうした測定値に基づいて、心機能治療が必要であるかどうかを判断することができる。
図3は、埋め込み型機器コントローラの適切なプログラミングによって実装可能な要求ベースの心機能治療の例示のアルゴリズムを示す。機器は、ステップ200で始動し、指定のペーシング・モードで、かつ指定のパルス出力構成とパルス出力シーケンスを使用する、ストレス低減ペーシングまたは再同期ペーシングなど心機能治療を開始する。ステップ201で、定期的な間隔で、またはテレメトリ・インターフェースを介した外部プログラマからのコマンドにより、機器は心機能治療のさらなる提供を停止する。ステップ202で、機器は次に、1つまたは複数の感知モダリティを使用して、患者の心機能の評価を開始する。この実施形態では、機器は、胸腔内インピーダンス方式で心拍数と心臓の1回拍出量の測定によって心拍出量を計算する。次いで、患者の運動レベル203(たとえば、活動レベルまたは分時換気)を測定し、ステップ203で測定された心拍出量と比較して、患者の心拍出量が前記特定の運動レベルに十分であるかどうかを判断する。ステップ204で、この比較に基づいて第1の心機能パラメータCFP1を計算することができ、それが指定閾値未満の場合は、心機能が不十分であることが示される。次にステップ205で患者の自律神経バランスを評価し、患者が受けた代謝ストレスの程度を示す第2の心機能パラメータCFP2を計算する。決定のために、このパラメータを指定閾値と比較することもできる。ステップ206で、機器は、計算された心機能パラメータCFP1とCFP2に基づいて、患者の心機能が不十分かどうかを判断する。不十分な場合、機器はステップ200に戻り、心機能治療を継続する。一方、計算された心機能パラメータにより、患者の心機能が十分に改善されたことが示された場合は、機器はステップ207で心機能治療のさらなる提供を無期限に停止する。
Claims (6)
- ペーシング・パルスを複数の心室部位に送出するようための複数のペーシング・チャネルに組み込むための一つ以上のパルス発生器と、
一つ以上のストレスを受けた或いは肥大性の心室領域を他の心室領域に対して事前に興奮させる方法で、前記心室領域にペーシング・パルスを送出することにより、心室リモデリングの逆転を行う心機能治療を提供するようにプログラムされたコントローラと、
心拍出量センサと、
運動レベルセンサと、を備え、
前記コントローラは、測定された心拍出量を測定された運動レベルと比較し、患者の心拍出量が前記測定された運動レベルに対して十分であるか否かを示す心機能パラメータを計算することによって、患者の心機能を評価するように更にプログラムされ、
前記コントローラは、心機能治療の提供を一時停止し、心機能治療が提供されない間に、心機能パラメータを閾値と比較することによって患者の心機能を評価し、患者の心機能が不十分だと判断された場合には、心機能治療の提供を継続し、患者の心機能が特定の程度まで改善したと判断された場合には、心機能治療の提供を終了するように更にプログラムされる、ことを特徴とする心機能治療を患者に提供するための埋め込み型機器。 - 前記心拍出量センサが、経胸インピーダンス測定回路である請求項1に記載の機器。
- 前記心機能の評価に、患者の心拍数変異性の測定による患者の自律神経バランスの評価が含まれる請求項1または2に記載の機器。
- 連続する室センス間の時間間隔を測定し、収集し、その収集した間隔を別々のRR間隔信号として記憶し、前記RR間隔信号を規定の高周波数帯域と低周波数帯域にフィルタリングし、それぞれLFとHFと呼ばれる各低周波数帯域と高周波数帯域のRR間隔信号の信号電力を決定する回路と、
LF/HF比を計算し、前記LF/HF比と指定した比の閾値とを比較することによって心機能を評価する回路とをさらに備える請求項3に記載の機器。 - 前記コントローラが、心機能治療の提供を一時停止し、外部プログラマからのコマンドにより患者の心機能を評価するようにプログラミングされる請求項1から4のいずれか1項に記載の機器。
- 前記コントローラが、心機能治療の提供を一時停止し、定期的な間隔で患者の心機能を評価するようにプログラミングされる請求項1から5のいずれか1項に記載の機器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US10/669,170 | 2003-09-23 | ||
US10/669,170 US7392084B2 (en) | 2003-09-23 | 2003-09-23 | Demand-based cardiac function therapy |
PCT/US2004/031062 WO2005030325A1 (en) | 2003-09-23 | 2004-09-23 | Demand-based cardiac function therapy |
Publications (2)
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JP2007521107A JP2007521107A (ja) | 2007-08-02 |
JP4689612B2 true JP4689612B2 (ja) | 2011-05-25 |
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JP2006528133A Expired - Fee Related JP4689612B2 (ja) | 2003-09-23 | 2004-09-23 | 要求ベースの心機能治療 |
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US (2) | US7392084B2 (ja) |
EP (1) | EP1667768B1 (ja) |
JP (1) | JP4689612B2 (ja) |
WO (1) | WO2005030325A1 (ja) |
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US8065003B2 (en) | 2011-11-22 |
EP1667768B1 (en) | 2015-09-02 |
US20080234776A1 (en) | 2008-09-25 |
EP1667768A1 (en) | 2006-06-14 |
WO2005030325A1 (en) | 2005-04-07 |
JP2007521107A (ja) | 2007-08-02 |
US7392084B2 (en) | 2008-06-24 |
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