JP2021532884A - 心筋酸素消費量を最小化するように心臓ポンプを制御するためのシステムおよび方法 - Google Patents
心筋酸素消費量を最小化するように心臓ポンプを制御するためのシステムおよび方法 Download PDFInfo
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Abstract
Description
本出願は、2018年7月31日に出願された「Systems and Methods for Controlling a Heart Pump to Minimize Myocardial Oxygen Consumption」と題する米国特許出願第16/050,542号の優先権および恩典を主張する。上記出願の内容全体が参照により本明細書に組み入れられる。
本開示は、心臓ポンプを制御するためのシステムおよび急性心筋梗塞(AMI)患者を治療するための関連する方法に関し、具体的には、AMI患者の治療中、左室(LV)の機械的減負荷を最大化し、心筋酸素消費量(MVO2)および結果的に梗塞サイズを最小化して、長期的心不全の発症を予防するように心臓ポンプの動作を制御するための閉フィードバック制御システムに関する。
一般的に心臓発作として知られるAMIは、心筋への血流が突然遮断されて組織損傷を生じさせるとき生じる、命を脅かす状態であるといえる。患部への不十分な血液供給のせいで、心臓中に壊死組織、すなわち梗塞が形成し得る。AMIは通常、冠動脈の1つまたは複数における閉塞の結果である。冠動脈は、酸素を豊富に含む血液を心筋に運ぶ。これらの動脈が閉塞または狭窄すると、心臓への血流は有意に減る、または完全に停止する。
本開示は、心臓血管不安定性の存在下で、LVの機械的減負荷を最大化し、MVO2および結果的に梗塞サイズを最小化して、引き続く心不全の発症を予防するやり方で制御される心臓ポンプを使用してAMI患者を治療するための、様々なシステム、装置および方法に関する。
(式中、Kはゲインであり、ζは減衰係数であり、fNは固有周波数であり、Lはタイムラグである)
と定義される、タイムラグを持つ二次遅れ系であることができる。いくつかの態様において、ゲインKは約0.013mmHg/rpmに等しくあることができ、減衰係数ζは約1.9に等しくあることができ、固有周波数fNは約0.41Hzに等しくあることができ、タイムラグLは約0.03秒に等しくあることができる。
以下、本明細書に開示されるシステム、装置および方法の構造、機能、製造および使用の原理の全体的理解を提供するために、特定の例示的な態様を説明する。これらの態様の1つまたは複数の例が添付図面に示されている。当業者は、本明細書に具体的に記載され、添付図面に示されるシステム、装置および方法が例示的な非限定的態様であること、ならびに本開示の範囲が特許請求の範囲のみによって画定されることを理解するであろう。1つの例示的な態様に関連して図示または記載された特徴が他の態様の特徴と組み合わされてもよい。そのような改変および変更は本開示の範囲に含まれると考えられる。本開示において、様々な態様の類似の番号を付された構成要素は一般に、それらの構成要素が類似の性質を有する、および/または類似の目的を果たす場合、類似の特徴を有する。当業者は、本開示を考慮して、異なる図面の間で類似の番号を付された構成要素どうしが同種である様々な例を理解するであろう。
式中、4つのパラメータは、ゲインK、減衰係数ζ、固有周波数fNおよび遅延時間Lである。項jは虚数単位を表す(j2=−1)。二次伝達関数H(f)は心臓血管系の解剖学的基本構造から生じるため、伝達関数は、ヒト心臓血管系に類似する解剖学的構造を有する多くの種に適用されることができる。伝達関数H(f)はまた、疾患状態下で心臓ポンプで補強された心臓をモデル化するためのプラントとしても使用することもできる。理由は、そのような状態は、心臓血管系の大きな解剖学的変化を伴う可能性が低いからである。
式中、Kpは比例ゲインであり、Kiは積分ゲインであり、Kdは微分ゲインであり、tは時間または瞬間であり、τは時間0から現在時tまでの値をとる積分の変数である。積分項は、制御装置のdeゲイン無限大を実質的に無限大に等しくするように構成されることができる。式u(t)は、ラプラスドメインにおいてU(s)=Kp+Ki/s and Kdsと書き換えることができる。
Claims (22)
- 心臓の左室内の左室収縮期圧(LVSP)を計測または計算するために使用される出力を生成するように構成されたセンサと;
心臓ポンプに結合され、該センサの該出力に基づいて該LVSPを計測または計算し、計測または計算されたLVSPに基づいて該左室の機械的減負荷を最大化するように該心臓ポンプの動作を制御するように構成された制御装置と
を含む、心臓ポンプを制御するためのシステム。 - 制御装置が、左室内のLVSPが目標基準圧に維持されるように心臓ポンプのポンプ速度および流量の1つまたは複数を制御するように構成されている、請求項1記載のシステム。
- 目標基準圧が、正常な拍出における収縮末期圧の比率に設定され、該比率が約0.2〜約0.4である、請求項2記載のシステム。
- 目標基準圧が、平均大動脈圧の比率に設定され、該比率が約0.2〜約0.4である、請求項2記載のシステム。
- 目標基準圧が、左室の圧・容積面積(PVA)を最小化するように設定されている、請求項2記載のシステム。
- 目標基準圧が、左室のPVAを約90%〜約97%最小化するように設定されている、請求項5記載のシステム。
- 目標基準圧が、左室の心筋酸素消費量(MVO2)を最小化するように設定されている、請求項2記載のシステム。
- 目標基準圧が、左室のMVO2を約45%〜約48.5%最小化するように設定されている、請求項7記載のシステム。
- 制御装置が、ポンプ速度の変化に応答するLVSPの変化をモデル化するプラント伝達関数に基づいて該LVSPを目標基準圧に維持するように心臓ポンプのポンプ速度および流量の1つまたは複数を制御するように構成されている、請求項2〜8のいずれか一項記載のシステム。
- ゲインKが約0.013mmHg/rpmに等しく、減衰係数ζが約1.9に等しく、固有周波数fNが約0.41Hzに等しく、タイムラグLが約0.03秒に等しい、請求項10記載のシステム。
- 制御装置が、臨床的に決定された応答時間未満で、かつ目標基準圧の10%未満のオーバシュートでLVSPが目標基準圧に達するように心臓ポンプのポンプ速度および流量の1つまたは複数を制御するように構成されている、請求項11記載のシステム。
- 制御装置が、プラント伝達関数の開ループゲインが16倍以下だけ変化するときLVSPを目標基準圧に維持するように心臓ポンプのポンプ速度および流量の1つまたは複数を制御するように構成されている、請求項11記載のシステム。
- 制御装置が、
約40に等しい比例ゲイン、約20に等しい積分ゲイン、および約0に等しい微分ゲインで構成された比例・積分制御装置
を含む、請求項11記載のシステム。 - 制御装置が、
プラント伝達関数を更新し、該プラント伝達関数の変化に応答して心臓ポンプのポンプ速度および流量の1つまたは複数を制御するように該制御装置を再構成するように構成された適応制御機構
を含む、請求項11記載のシステム。 - 請求項1〜15のいずれか一項記載のシステムを使用して急性心筋梗塞(AMI)患者を治療するための方法。
- 患者の心臓の左室(LV)内の左室収縮期圧(LVSP)を計測または計算する工程であって、心臓ポンプが、該LVから大動脈への血液の機械的減負荷を実行するために該心臓に植え込まれている、計測または計算する工程と、
計測または計算されたLVSPに基づいて該LVの該機械的減負荷を最大化するように該心臓ポンプの動作を制御する工程と
を含む、急性心筋梗塞(AMI)患者を治療するための方法。 - 心臓ポンプの動作を制御する工程が、LV内のLVSPが目標基準圧に維持されるように該心臓ポンプのポンプ速度および流量の1つまたは複数を制御することを含む、請求項16記載の方法。
- 目標基準圧が、正常な拍出における収縮末期圧の比率に設定され、該比率が約0.2〜約0.4である、請求項17記載の方法。
- 目標基準圧が、平均大動脈圧の比率に設定され、該比率が約0.2〜約0.4である、請求項17記載の方法。
- 目標基準圧が、左室の圧・容積面積(PVA)を約90%〜約97%最小化するように設定されている、請求項17記載の方法。
- 目標基準圧が、LVの心筋酸素消費量(MVO2)を約45%〜約48.5%最小化するように設定されている、請求項17記載の方法。
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