JP2012502670A - 心臓活動を正確に分類する方法およびデバイス - Google Patents
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Abstract
Description
2)N−3、N−4、およびN−5と比較するときの、N−2についての交互の低−高−低。
結論:N−1およびN−3をT波として扱う。
さらなる確証的規則は、
3)静的テンプレートに対するNおよびN−2についての少なくとも「中間の(Medium)」」相関
であってよい。別の手法は、規則のセットが満たされることに応答してN−1だけを過検出としてマーク付けしながら、規則1)および3)だけを適用することである。1つまたは複数の事象は、過検出としてマーク付けされると、上記図3Bに示す方法で扱われてもよい。
2.N−1およびN−2の事象は、Nの事象に対して低い相関を有する。
3.N−1およびN−2の事象は、静的テンプレートに対して低い相関を有する。
そして、1〜4の全てが満たされる場合、N−1およびN−2が廃棄され、NからN−3までの間隔が、計算され、レート解析で使用されてもよい。
5.N−1およびN−2の事象は、幅閾値より広い。
幅閾値は、所望に応じて設定されてもよい。一実施例では、幅閾値は、100から140msの範囲にある。この幅閾値規則は、事象が過検出として廃棄されるという任意の判定に対する付加的な層として適用されてもよい。別の実施例では、極性が考慮されてもよい。
極性は、たとえば、事象について大部分の信号サンプルを参照することによって、その事象において最大マグニチュードを有するサンプルの極性として、または、事象における最大の正または最小の正のいずれの極値が、最初に起こるかを判定することによって規定されてもよい。
7.所定の継続時間未満の結合間隔N〜N−3
ここで、「所定の継続時間(Duration)」は、800〜1200msの範囲である。この条件およびその変形はまた、以下の図11〜13および14A〜14Bに関連して説明される。
図11に示すように、QRS群は260にて起こり、続いて、262に示す心室期外収縮(PVC)が起こり、続いて、264にて別のQRS群が起こる。PVCは、この実施例では、テンプレートに対する低い相関を特徴とする。そのため、図3Aで先に示したパターンと同様の、高−低−高の相関パターンが現れる。したがって、一つの実施例は、PVC262を廃棄するものとなる。しかし、解析的には、PVC262が、実際には、過検出事象でないため、PVC262を廃棄することは必要でない可能性がある。さらに、PVC262の周りの間隔は共に、500ミリ秒より大きい。たとえデータ補正がない場合でも、2つの間隔の平均は、約103拍動/分の事象レート、不必要な治療をもたらす怖れがないと思われるレートをもたらすこととなる。そのため、データ補正は、拍動感度を低減しながら、デバイス内の律動特異性を改善しないであろう。
1.静的テンプレートと比較する:一致する場合、ショック不可能である、そうでなければ、
2.動的テンプレートと比較する:一致しない場合、ショック可能である、そうでなければ、
3.QRS幅閾値と比較する:幅広である場合、ショック可能であり、そうでなければショック不可能である。
ここで、動的テンプレートは、以下のもののうちの任意のものでありうる。
b)個々の事象のセット、たとえば、{N−1、…、N−i}、ここで、個々の事象の一部または全てに一致することは、動的テンプレートに一致することとして計数する、
c)連続して更新されるテンプレート。
y)QRS幅は、プログラミングセッション中に患者について測定され、113msの最大許容可能値を有し、
z)解析中のQRS幅は、QRS幅閾値より少なくとも20ms長い場合、幅広であると考えられる。
これらの規則x)、y)、およびz)は、1つの特定の実施形態に対して調節され、使用されるシステムに応じて変わる可能性がある。
Claims (17)
- 埋め込み型心臓刺激(ICS)システムであって、
該ICSシステム用のキャニスタハウジング作動回路要素と、キャニスタ電極が配設されているキャニスタと、少なくとも第1のリード線電極が配設されているリード線とを備え、前記キャニスタ電極および前記第1のリード線電極が前記作動回路要素に電気的に接続されており、前記作動回路要素が、
患者内で起こる電気事象を検出すること、
前記検出された電気事象のための複数の事象表示を構築することであって、各事象表示が一連のサンプルを含む、前記複数の事象表示を構築すること、
テンプレート基準点を有するテンプレートと第1の事象表示との比較を行うことであって、前記第1の事象表示内で事象基準点を識別し、該事象基準点と前記テンプレート基準点とを互いにアライメントし、該アライメントしたときに前記テンプレートと前記第1の事象表示との間の第1の相関を計算することによって前記比較を行うこと、
前記テンプレートと前記第1の事象表示との比較を再び行うことであって、前記事象基準点と前記テンプレート基準点との異なるアライメントを選択することによって前記比較を再び行うこと、
少なくとも前記第1の相関または第2の相関から、より大きな相関を示すものを前記第1の事象表示についての相関結果として選択すること、
正確な事象検出が行われているかどうかを一連の相関結果を使用して判定し、正確な事象検出が行われていない場合、不正確な事象検出に応答してデータを補正すること、
潜在的な心臓不整脈が起こっているかどうかを判定し、起こっている場合、刺激が必要かどうかを判定すること、および、
刺激が必要な場合、前記ICSシステムから患者へ電気刺激を送出すること
を含む方法を実施するように構成されている、ICSシステム。 - 前記作動回路要素は、前記方法が、前記事象基準点を前記テンプレート基準点からミスアライン状態にし、前記第1の事象表示と前記テンプレートとの間の第3の相関を計算することによって前記第1の事象表示を前記テンプレートと比較する別のステップを含むようにさらに構成されており、
前記第2の相関は、前記テンプレート基準点よりも前の1つまたは複数のサンプルにアライメントされた前記事象基準点を用いて計算され、前記第3の相関は、前記テンプレート基準点よりも後の1つまたは複数のサンプルにアライメントされた前記事象基準点を用いて計算される、請求項1に記載のICSシステム。 - 前記作動回路要素は、前記第2の相関が、第1の方向に前記テンプレート基準点から1サンプル離れてアライメントされた前記事象基準点を用いて計算されるようにさらに構成されており、
前記第2の相関が前記第1の相関より大きい場合、前記方法は、前記第1の方向に前記テンプレート基準点から2サンプル離して前記事象基準点をアライメントし、前記第1の事象表示と前記テンプレートとの間の第3の相関を計算することによって前記第1の事象表示を前記テンプレートと比較するさらに別のステップをさらに含み、
前記第2の相関が前記第1の相関より小さい場合、前記方法は、前記第1の方向と反対の方向に前記テンプレート基準点から1サンプル離して前記事象基準点をアライメントし、前記第1の事象表示と前記テンプレートとの間の第3の相関を計算することによって前記第1の事象表示を前記テンプレートと比較するさらに別のステップを、前記作動回路要素が実施することをさらに含む、請求項1に記載のICSシステム。 - 前記作動回路要素は、前記正確な事象検出が行われているかどうかを一連の相関結果を使用して判定する前記ステップが、相関結果の交互の高−低−高のパターンが起こっているかどうかを判定し、起こっている場合、低い相関結果を有する事象表示が、過検出信号から生じていると判定することを含むようにさらに構成されている、請求項1に記載のICSシステム。
- 前記作動回路要素は、前記方法が更に、前記第1の事象表示についての相関結果を閾値と比較することによって、一連の検出事象がショック可能かショック不可能かを判定することと、前記相関結果が前記閾値を超える場合、前記第1の事象表示に対応する検出事象がショック不可能であると判定することとを含むようにさらに構成されている、請求項1に記載のICSシステム。
- 埋め込み型心臓刺激(ICS)システムであって、
該ICSシステム用のキャニスタハウジング作動回路要素と、キャニスタ電極が配設されているキャニスタと、少なくとも第1のリード線電極が配設されているリード線とを備え、前記キャニスタ電極および前記第1のリード線電極が前記作動回路要素に電気的に接続されており、前記作動回路要素が、
患者内で起こる心臓電気事象を検出すること、
前記検出された電気事象のための事象表示を構築すること、
一組の前記検出された電気事象を使用して心拍数を計算すること、
前記事象表示と既知の心臓状態を表すテンプレートとを比較して一組の相関を確立するすること、
以下の2つのパターンのうちの1つについて前記一組の相関を解析することであって、前記2つのパターンが、
a)第1の境界の周りに高−低−高のパターンを含む、3つ以上の連続する相関の組を必要とする短いパターン、
b)第2の境界の周りに高−低−高−低−高のパターンを含む、5つ以上の連続する相関の組を必要とする長いパターン、
であり、ここで、前記第1の境界は、前記第2の境界に比べて、「高」について強い相関を必要とするものである、前記一組の相関を解析すること、
前記短いパターンか、または、前記長いパターンが識別される場合、1つまたは複数の検出事象を過検出であるとして特徴付けて、前記計算された心拍数を修正すること、
潜在的な心臓不整脈が起こっているかどうかを判定し、起こっている場合、刺激が必要かどうかを判定すること、および、
刺激が必要とされる場合、ICSシステムから患者へ電気刺激を送出すること
を含む方法を実施するように構成されている、ICSシステム。 - 前記第2の境界は、
前記一組の相関において平均相関を識別すること、および、
前記平均相関よりも上の設定距離のところに上限を確立すること
によって規定される、請求項6に記載のICSシステム。 - 以下のパターンについて前記一組の検出を解析することをさらに含み、該パターンが、
c)高−低−低の相関の少なくとも2つのシーケンスを含む3重パターンであり、
前記方法は、前記3重パターンが識別される場合、各「低」事象を過検出として特徴付け、心拍数を再計算するときに使用するための、高い事象間の間隔を計算することを含む、請求項6に記載のICSシステム。 - 埋め込み型心臓刺激(ICS)システムであって、
該ICSシステム用のキャニスタハウジング作動回路要素と、キャニスタ電極が配設されているキャニスタと、少なくとも第1のリード線電極が配設されているリード線とを備え、前記キャニスタ電極および前記第1のリード線電極が前記作動回路要素に電気的に接続されており、前記作動回路要素が、
患者内で起こる電気事象を検出すること、
一組の前記検出された電気事象を使用して、心拍数を計算すること、
1つまたは複数の検出事象を、過検出のために起こっている可能性があるものとして識別すること、
潜在的な過検出がT波である可能性があるかどうかを判定するために、前記過検出のために起こっている可能性があるものとして識別された前記検出事象の周りの間隔を解析することであって、
a)前記潜在的な過検出がT波である可能性がある場合、計算された心拍数を減らすために前記過検出に関するデータを補正し、
b)前記潜在的な過検出がT波である可能性がない場合、少なくとも前記潜在的な過検出の間、ICSシステム内のデータ補正法を使用不能にする、
ために前記検出事象の周りの間隔を解析すること、
潜在的な心臓不整脈が起こっているかどうかを判定し、起こっている場合、刺激が必要かどうかを判定すること、および、
刺激が必要とされる場合、ICSシステムから患者へ電気刺激を送出すること
を含む方法を実施するように構成されている、ICSシステム。 - 前記作動回路要素は、前記潜在的な過検出がT波である可能性があるかどうかを判定するために前記間隔を解析することが、前記潜在的な過検出ならびに前記直前の検出事象および前記直後の検出事象に対して、QT期間とRR間隔との間の受容関係を適用することを含むようにさらに構成されており、前記QT期間とRR間隔との間の受容関係を適用することが、
前記直前の検出事象および前記直後の検出事象についての間隔をRR間隔として扱い、
前記直前の検出事象および前記潜在的な過検出についての期間をQT間隔として扱い、
前記間隔および前記期間に対して前記受容関係を適用し、
前記受容関係が成り立つ場合、前記潜在的な過検出がT波である可能性があると判定し、
前記受容関係が成り立たない場合、前記潜在的な過検出がT波である可能性がないと判定する
ように行われる、請求項9に記載のICSシステム。 - 前記作動回路要素は、前記受容関係が、バゼットの公式か、フリデリシアの公式か、または回帰式の群から選択されるようにさらに構成されている、請求項10に記載のICSシステム。
- 前記作動回路要素は、前記潜在的な過検出がT波である可能性があるかどうかを判定するために前記間隔を解析することが、前記潜在的な過検出と直前の検出事象との間の間隔を閾値と比較し、閾値を超える場合、前記潜在的な過検出がT波である可能性がないことを見出すことを含むようにさらに構成されている、請求項9に記載のICSシステム。
- 埋め込み型心臓刺激(ICS)システムであって、
該ICSシステム用のキャニスタハウジング作動回路要素と、キャニスタ電極が配設されているキャニスタと、少なくとも第1のリード線電極が配設されているリード線とを備え、前記キャニスタ電極および前記第1のリード線電極が前記作動回路要素に電気的に接続されており、前記作動回路要素が、
患者内で起こる電気事象を検出すること、
前記検出された電気事象のための事象表示を構築すること、
一組の事象N、N−1、N−2、およびN−3について、相関解析により、前記N番目の事象を、前記N−1、N−2、およびN−3の事象のそれぞれと比較すること、
前記相関解析の結果を使用して、前記一組の事象が、過検出、良性心律動、または潜在的な心臓不整脈のうちの1つを示すかどうかを判定すること、および、
潜在的な心臓不整脈が識別される場合、刺激が必要とされるかどうかを判定し、刺激が必要とされる場合、ICSシステムから患者へ電気刺激を送出すること
を含む方法を実施するように構成されており、
前記相関解析が、過検出に相当する、事象Nと事象N−1と事象N−2と事象N−3との間の相関パターンを示す場合に、過検出が識別されることを特徴とするICSシステム。 - 前記作動回路要素は、前記相関解析により、N番目の事象を、N−1番目、N−2番目、およびN−3番目の事象のそれぞれと比較する前記ステップが、N−1およびN−3の事象に対する低い相関のパターン、およびN−2の事象に対する高い相関のパターンをもたらす場合に、前記方法が、過検出が起こっていると判定することを含むようにさらに構成されている、請求項13に記載のICSシステム。
- 前記作動回路要素は、前記方法が、
前記検出された電気事象を使用して心拍数を計算すること、および、
前記一組の事象N、N−1、N−2、およびN−3が過検出を示す場合に、1つまたは複数の過検出事象に関するデータを補正し、前記計算された心拍数を再計算することをさらに含むようにさらに構成されている、請求項13に記載のICSシステム。 - 前記作動回路要素は、前記一組の事象が、過検出、良性心律動、または潜在的な心臓不整脈のうちの1つを示すかどうかを判定する前記ステップが、N番目の事象が、N−1番目、N−2番目、またはN−3番目の事象の少なくとも1つに対して高い相関を持つかどうかを判定し、高い相関を持つ場合、良性心律動が起こっていると判定することを含むようにさらに構成されている、請求項13に記載のICSシステム。
- 前記作動回路要素は、前記一組の事象が、過検出、良性心律動、または潜在的な心臓不整脈のうちの1つを示すかどうかを判定する前記ステップが、N番目の事象が、N−1番目、N−2番目、またはN−3番目の事象のそれぞれに対して近い相関を持つかどうかを判定し、近い相関を持つ場合、良性心律動が起こっていると判定することを含むようにさらに構成されており、ここで、「高い相関を持つ」は、「近い相関を持つ」より比較的高い相関を示すものである、請求項16に記載のICSシステム。
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