JP2022190053A - 補助人工心臓 - Google Patents
補助人工心臓 Download PDFInfo
- Publication number
- JP2022190053A JP2022190053A JP2022175971A JP2022175971A JP2022190053A JP 2022190053 A JP2022190053 A JP 2022190053A JP 2022175971 A JP2022175971 A JP 2022175971A JP 2022175971 A JP2022175971 A JP 2022175971A JP 2022190053 A JP2022190053 A JP 2022190053A
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- Prior art keywords
- vad
- heart
- blood
- control device
- speed
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
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Images
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Abstract
Description
ΔAoP(h)=AoP|max(h)-AoP|min(h)
のことであると理解される。
AoP|max(j)=maxk{AoP(tj,k)} 但しk=0,…,mj
では指数jにより第j心拍が指し示されており、第j心拍に係る信号AoPの最大値が、第j心拍の冒頭計測点k=0で始まり次の第(j+1)心拍の開始直前の最終計測点k=mjで終わるk=0,…,mj全てでの信号AoPの計測値を対象にして、計算されている。以後は
AoP|max(j+1)=maxk{AoP(tj+1,k)} 但しk=0,…,mj+1
等々となる。
生理学的(非補助時)拍動性:ΔAoP(h)=AoP|max(h)-AoP|min(h)
所望(補助時)最小拍動性:ΔAoP~(h)=AoP~|max(h)-AoP~|min(h)
拍動性差:ΔAoPpulse(h)=ΔAoP~(h)-ΔAoP(h)
の通りである(図3aも参照あれ;本願にて「~」はAoPの上に波線の意)。
Qtotal|max(h)=Qheart|max(h)+QVAD|max(h)
並びに心拍毎総駆出体積(EV)
EV(h)=EVheart(h)+EVVAD(h)
により、収縮期全身血圧の適切な上昇を引き起こすことができる。生来の心臓の共同駆出能は、心室性前負荷、心室充満レベル及び心収縮性のレベル、並びにVADの実現可能ピーク流により左右されうる。生来の心臓の共同駆出能は、その患者の肥満指数、或いは体表面積、或いは血管コンプライアンス、並びに末梢抵抗によっても左右されうる。
Qtoal|max(h)=Qheart|max(h)+QVAD|max(h)>6L/min,…,10L/min
なる総ピーク流、ひいては
EV(h)=EVheart(h)+EVVAD(h)=40ml,…,70ml
なる総駆出体積をもたらす収縮期ピーク流速とするのが望ましく、それにより所望最小拍動性ΔAoP~(h)>[15,…,30]mmHgを達成することができる。
Δp(t)=AoP(t)-LVP(t)
により左右される。
IVAD(t)=f(nVAD set(t),Δp(t))
となる。
nVAD set(t)=nVAD set,basic(j)
から、速度パルスの開始に際する増強速度レベル
nVAD set(t)=nVAD set,basic(j) +ΔnVAD set(j)
への速度上昇を呈しており、ΔnVAD set(j)により速度パルス内速度差が表されている。
nVAD set(t)=nVAD set,basic(j) +ΔnVAD set(j)
から基本速度レベル
nVAD set(t)=nVAD set,basic(j)
へと低下、復帰することも示されている。
Qtotal|max(h)=Qheart|max(h)+Qpump|max(h)>6L/min,…,10L/min
なる総ピーク流を誘起させ、
EV(h)=EVheart(h)+EVpump(h)=40,…,70ml
なる総駆出体積がもたらされるようにすべきであり、それにより所望最小拍動性ΔAoP~(h)≧15,…,30mmHgを達成することができる。とはいえ、目標となる所望最小拍動性ΔAoP~(h)は固定値ではなく、vWFの補充より変動しうる。更に、虚弱心臓の生来の拍動性だけでも所望最小拍動性を上回っている場合、無論のことその拍動性を低減させる必要はなかろう。
Claims (19)
- 非拍動型の補助人工心臓即ちVAD(50)の回転速度(nVAD(t))を事象ベース拍内制御策によって制御する制御装置(100)であり、被補助心臓の心周期内で当該VAD(50)の回転速度(nVAD(t))を変更するよう、且つその心周期内の少なくとも1個の所定特徴事象に関わる少なくとも1系列のトリガ信号(σ(t))により当該回転速度(nVAD(t))の変更を心拍と同期させるよう、構成されている制御装置。
- 請求項1の制御装置(100)であって、上記VAD(50)の回転速度(nVAD(t))を所定のパルス持続時間(τpulse(h))又は心拍数依存性パルス持続時間(τassist(h))に亘り変更することで所定所望最小拍動性(ΔAoP~(h))を注目動脈にて上記心周期内で発生させるよう、且つ上記少なくとも1系列のトリガ信号(σ(t))により当該速度変更の開始及び/又は終了を同期させるよう、構成されている制御装置。
- 請求項2の制御装置(100)であって、速度指令信号(nVAD set(t))を生成し上記VAD(50)の回転速度(nVAD(t))の変更に供することで上記所定所望最小拍動性(ΔAoP~(h))を達成するよう、またそれを
開ループ制御による第1機構であり、上記速度指令信号(nVAD set(t))が指令信号発生器(120)を用い所定回転速度レベル間で変更されるもの、或いは
フィードバック系内閉ループ圧力制御による第2機構であり、上記速度指令信号(nVAD set(t))が心拍(h)毎に自動設定されるもの、
にて達成するよう、構成されている制御装置。 - 請求項3の制御装置(100)であって、上記速度指令信号(nVAD set(t))を調整することで上記所定所望最小拍動性(ΔAoP~(h))を上記第2機構にて達成するよう構成されている制御装置。
- 請求項2乃至4のうちいずれか一項に係る制御装置(100)であって、上記VAD(50)の回転速度(nVAD(t))を変更することで、上記所定所望最小拍動性(ΔAoP~(h))を相連続するx個の被補助心臓心周期のうちy個のみで発生させるよう、構成されており、xが2より大きい整数、yがy≦xを満たす整数である制御装置。
- 請求項5に係る制御装置(100)であって、相連続する他のx-y個の被補助心臓心周期のうち少なくともy個にて上記VAD(50)の回転速度(nVAD(t))を設定することで、心拍毎平均動脈血圧(AoP-(h))を所定のしきい値(AoP- thr(h))より上に保つよう、構成されている制御装置。
- 請求項2乃至6のうちいずれか一項の制御装置(100)であって、更に、上記速度指令信号(nVAD set(t))を調整することで心拍毎平均動脈血圧(AoP-(h))を所定のしきい値(AoP- thr(h))より上に保つよう構成されている制御装置。
- 請求項2乃至7のうちいずれか一項の制御装置(100)であって、上記少なくとも1個の所定特徴事象のうち1個が生起するより所定の第1期間(τincr(h))前にて上記速度指令信号(nVAD set(t))の調整を開始するよう構成されており、その特徴事象が、好ましくは、心室収縮の開始と、被補助心臓が付された患者からもたらされる心電図信号即ちECG信号におけるR波(R)の生起と、のうち少なくとも一方である制御装置。
- 請求項2乃至8のうちいずれか一項の制御装置(100)であって、上記所定のパルス持続時間(τpulse(h)))の経過、適合化された心拍数依存性パルス持続時間(τassist(h))の経過、上記心周期における上記少なくとも1個の所定特徴事象のうち1個の生起、その心周期にてその所定事象が生起する以前の所定の第2期間(τred(h))の経過、のうち少なくとも一つに従い上記速度指令信号(nVAD set(t))の調整を終了するよう構成されており、上記心周期における上記少なくとも1個の所定特徴事象が、好ましくは、被補助心臓の心室弛緩の開始と、大動脈弁の閉止と、のうち少なくとも一方である制御装置。
- 請求項1乃至9のうちいずれか一項の制御装置(100)であって、上記VAD(50)のアクチュエータに供給される電流から上記少なくとも1系列のトリガ信号(σ(t))のうち1個を導出するよう構成されている制御装置。
- 請求項10の制御装置(100)であって、上記VAD(50)の回転速度(nVAD(t))の変更による電流変化を、被補助心臓がその心周期を経ることで引き起こされる電流変化から弁別するよう、構成されている制御装置。
- 請求項1乃至11のうちいずれか一項の制御装置(100)であって、被処理計測信号たる少なくとも1個の信号から上記少なくとも1系列のトリガ信号(σ(t))を導出するよう構成されており、その被処理計測信号が次の物理量、即ち上記VAD(50)の血液駆出用アウトレットとそのVAD(50)の血液吸入用インレットとの間の血圧差、被補助心臓の心室内血圧、被補助心臓近隣大動脈内血圧、被補助心臓近隣大静脈内血圧、被補助心臓近隣肺動脈内血圧、のうち少なくとも1個を表すものである制御装置。
- 請求項1乃至12のうちいずれか一項の制御装置(100)であって、上記少なくとも1個の被処理計測信号のうち少なくとも1個から循環器系についての特徴的情報を上記心周期内で導出するよう、且つ、先行する心周期中に求まった特徴情報に基づき後来心周期に関し上記少なくとも1個の特徴事象を導出又は予測するよう、構成されている制御装置。
- 請求項13の制御装置(100)であって、上記事象を導出又は予測する際に少なくとも2個の被処理計測信号から上記VAD(50)の回転速度(nVAD(t))の変更の影響を導出するよう、構成されている制御装置。
- 請求項1乃至14のうちいずれか一項の制御装置(100)であって、被補助心臓の心周期のうち拡張期には大動脈内又は肺動脈内へと駆出される血液の量が対応する心室における血液体積を保つものとなり、且つ、収縮期におけるVAD(50)及び心室の共同駆出により所定最小総ピーク血流(Qtotal|max(h))が好ましくは少なくとも6L/min、より好ましくは8L/minとなるように、上記VAD(50)の回転速度(nVAD(t))を制御するよう、構成されている制御装置。
- 請求項1乃至15のうちいずれか一項に係る制御装置(100)であって、心臓の収縮期にて上記VAD(50)の回転速度(nVAD(t))を上昇させるよう、及び/又は、心臓の拡張期にてそのVAD(50)の回転速度(nVAD(t))を低下させるよう、構成されており、どちらの場合も好ましくは基本速度レベル(nVAD set,basic(t))が基準とされる制御装置。
- 請求項1乃至16のうちいずれか一項に係る制御装置(100)であって、被補助心臓で現在求められている最小血流需要より上に平均VAD誘起性血流を設定しうる場合に限り上記VAD(50)の回転速度を変更するよう構成されている制御装置。
- 心補助用のVAD(50)であって、請求項1乃至17のうちいずれか一項の制御装置(100)を備え、好ましくは非拍動ロータリ血液ポンプであり、その血液ポンプが好ましくはカテーテル式であるVAD。
- 請求項18に係り低慣性装置たるVAD(50)であって、その低慣性装置が以下の特性、即ちそのVADの可動部品特に回動部品例えばロータ又はインペラが軽量素材例えばプラスチックにより製作されていて低質量を有すること、駆動手段例えば電動モータがそのモータにより駆動される部品例えばロータ又はインペラの近く、好ましくはすぐ近く、最も好ましくは隣り合わせに配置されており、カテーテル式ならばそのモータが好ましくは回転駆動ケーブル又は駆動ワイヤを有していないこと、上記モータにより駆動される部品例えばロータ又はインペラに対する上記モータの結合又は連結手段例えばシャフトが短いこと、そのVADの全ての可動部品特に回動部品が小さな直径を有していること、という特性のうち1個又は複数個を有するVAD。
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