JP4926064B2 - モニタされた心臓血管パラメータに基づいた圧反射調節 - Google Patents
モニタされた心臓血管パラメータに基づいた圧反射調節 Download PDFInfo
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Description
2004年9月13日に提出され、本願明細書に参照で組み入れる米国特許出願第10/939544号に優先権の恩典を主張する。
本出願は、2003年12月24日に提出され、その全文を本願明細書に参照で組み入れる「Automatic Baroreflex Modulation Based on Cardiac Activity」という表題の米国特許出願第10/746846号の一部継続出願である。
読者がこの開示を理解するのを手助けするために、高血圧と圧反射に関する生理学の簡単な考察が行われる。この簡単な考察は高血圧、自律神経系、圧反射を紹介する。
本主題事項の様々な実施形態は圧反射刺激システムに関する。そのような圧反射刺激システムは本願明細書では神経刺激(NS)デバイスまたは部品とも称される。神経刺激装置の例は高血圧を治療するために使用される抗高血圧(AHT)デバイスまたはAHT部品を含む。本主題事項の様々な実施形態は独立型の埋込可能な圧受容器刺激システムを含み、NSを集積化した埋込可能なデバイスと心調律管理(CRM)部品を含み、無線またはリード線で接続する埋込可能なデバイスのどちらかで互いに通信することが可能な少なくとも1つの埋込可能なNSデバイスと埋込可能なCRMデバイスとを備えたシステムを含む。同じデバイスまたは別々のデバイスのどちらかで実行されるNS機能とCRM機能の集積化は、NS療法と心臓治療が一緒に知能的に作用することを可能にすることによってこれらの治療の態様を向上させる。
2つの別々で異なる埋込可能なデバイスとして実装されたか、あるいは部品として1つの埋込可能なデバイスの中に集積化された、システムのNSおよび/またはCRM機能はNSおよび/またはCRM療法あるいは治療の一部を遂行するための処理過程を有する。いくつかの実施形態では、NS療法はAHT治療を実施する。これらの処理過程は、例えば、メモリに内蔵されたコンピュータ読み取り可能な命令を実行するプロセッサによって実行されることが可能である。これらの療法は様々な処理と機能を有するいくつかのアプリケーションを含み、これらのいくつかは下記で確認され、考察される。これらの療法の処理と機能は、本主題事項のいくつかの実施形態が下記で確認される2つ以上の処理と機能の組合せを有するので必ずしも相互排他的ではない。
図16A〜16Dは神経刺激(NS)デバイスからの電気刺激と心臓律動管理(CRM)デバイスによる感知の間の妨害を阻止するための、本主題事項の様々な実施形態によるシステムと方法を示している。神経刺激は信号を感知する能力を高め、したがって心臓の事象の検出に付随する偽陽性を減少させるかまたは除去する責任を負う。NSデバイスはいくつかの実施形態においてAHTデバイスを有する。例えば、いくつかの実施形態によると、CRMデバイスが故意でなく圧反射刺激に反応しないようにNSデバイスは通信を行い、圧反射刺激を阻止するかさもなければ補償する。いくつかの実施形態は圧反射刺激を心臓内の適切な屈折と自動的に同期させる。例えば、いくつかのシステムは肺動脈の中または近傍の圧受容器の刺激を心房興奮と自動的に同期させる。したがって、たとえ心臓と、心臓の電気興奮を検出するCRMセンサの近くで圧反射刺激が生じても、CRMデバイスの機能が圧反射刺激によって生じるファーフィールドノイズを検出することで悪影響を受けることはない。
交感または副交感神経系の活性化は、特定の心臓収縮間隔や、主として駆出前の期間(PEP)、心室内で感知される電気的活性(例えば「R」波の感知)の間の時間的間隔、血液の心室駆出の開始を変化させることが知られている。PEPは肺動脈圧センサを使用して、感知された電気的事象から肺動脈内の圧力上昇の開始までを測定することが可能であり、または駆出時の心室容積の減少に付随する心臓内インピーダンスの増加の開始までを、右心室の中または左心室に及んで配置された電極を使用して測定することが可能である。例えば心拍数または加速度計で測定される身体活動によって判定される休息時では、神経刺激を、予めプログラムされた範囲にPEPを維持するように変える。PEPの突然の減少は運動または情緒的ストレスに付随する交感神経系の緊張の高まりを示す。この状態は、神経刺激を減らして代謝要求に合致するのに必要な心拍数を増加させ、収縮性を増加させるのに使用される。同様の様式で、引き続いて生じるPEPの劇的な延長は増大した代謝要求の終了を特徴付ける。この時に、神経刺激による血圧の制御が再開される。
本主題事項は、例えば心拍数、毎分換気量、加速度、これらの組合せによって判定されるような心臓活動に基づいて圧受容器刺激を自動的に変える方法を記述する。圧受容器を電気的に刺激するためのデバイスの機能性は、代謝要求が相対的に低い休息時に少なくとも相対的に高いボロペーシング速度を加え、代謝要求が増大する身体運動時に徐々に低いボロペーシングを加えることによって強化される。心臓活動の指標は圧受容器の電気刺激を自動的に変えるために使用され、埋込可能な抗高血圧デバイスが代謝要求の変化に応答することを可能にする。様々な実施形態によると、ペースメーカ、AICDまたはCRTデバイスなどのCRMデバイスは圧受容器刺激用リード線も同様に備えている。このデバイスは、例えば混成センサを使用する既存の方法を通じて心臓活動をモニタする。混成センサは加速度や毎分換気量などのパラメータを測定するために2つのセンサを含む。混成センサの出力は複合パラメータを表す。様々なNSとAHT療法はこの開示の中で考察されるように2つ以上の感知されたパラメータから派生する複合パラメータを使用する。休息時(低い心臓活動)では、このデバイスは高速で圧受容器を刺激し、血圧を下げて高血圧を制御する。心臓活動が上昇すると、このデバイスは一時的に圧受容器刺激を減少させることによって応答する。これは結果として血圧と心拍出量の一時的な上昇につながり、身体を増大した代謝要求に応答できるようにする。例えば、いくつかの実施形態は休息時に圧反射刺激を供給し、運動時に圧反射刺激を引き下げて運動に対応した通常の血圧に一致させる。活動を判定するために圧力トランスデューサを使用することが可能である。さらに、心拍感応型ぺーシングを推進するために使用され、または使用されてきたセンサを使用して活動を感知することも可能である。そのようなセンサの例は身体の動き、心拍数、QT間隔、呼吸速度、経胸腔インピーダンス、1回換気量、毎分換気量、身体姿勢、脳波図(EEG)、心電図(ECG)、眼電図(EOG)、筋電図(EMG)、筋緊張、体温、脈波型酸素飽和度測定、時刻、(心臓内インピーダンスから)駆出前間隔を検出するためのセンサを含む。
本主題事項の態様は、血管拡張応答を増大させるため、および心筋虚血損傷を潜在的に阻止するためまたは減少させるために有害な心臓の事象を検出すると圧受容器刺激を自動的に増大させる方法を含む。様々な実施形態が、心臓律動管理デバイス(例えばペースメーカ、AICDまたはCRTデバイスなど)内にフィードバック・メカニズムを有し、そのデバイスも同様に圧受容器を電気的に刺激するための刺激用リード線を有する。このデバイスは既にある方法を通じて心臓の電気的活動をモニタする。心室細動(VF)と心房細動(AF)、予め規定された速度を上回る心室頻脈(VT)と心房頻脈(AT)、さらには毎分換気量センサによって検出される呼吸困難、狭心症、代償不全、虚血などの有害な心臓事象の事象で、このデバイスは圧受容器刺激を最大許容レベルまで上げることによって対応する。結果として、血圧が一時的に下げられ、虚血に起因する心筋の損傷を潜在的に阻止するかまたは減少させる。圧受容器刺激の量を一時的に変えることによって有害な心臓事象に対応することが可能であれば、高血圧を治療するデバイスの機能性を広げることが可能である。事象検出アルゴリズムが圧受容器刺激を自動的に変え、埋込可能なAHTデバイスが圧受容器刺激を増大させることによって有害事象に対応することを可能にし、心筋の虚血損傷を潜在的に阻止するかまたは減少させる。
本主題事項の態様は、24時間にわたって起こる血圧の自然な変動を模倣するように高血圧患者で圧反射を刺激するための方法に関する。高血圧における反射の減少は動脈圧の内因性変動を変えることなく長期間の圧受容器刺激の中で達成される。様々な実施形態によると、例えば埋込可能なデバイスは頸動脈洞、肺動脈、または大動脈弓内で高周波数のバースト(例えば約20〜150Hzの範囲内の周波数を備えた矩形波)を使用して圧受容器を刺激するように設計される。いくつかの実施形態は頸動脈洞神経、大動脈神経、または迷走神経をカフ電極で直接刺激する。しかしながら、バーストは一定の速度で起こらない。どちらかといえば刺激の周波数、振幅、および/またはバースト周波数は1日の中で自然の日周期リズムを模倣して上下する。
本主題事項の態様は、圧反射を刺激することによって全身血圧を下げるためのNS療法を実施し、速度制御のための心臓ペーシング用リード線を使用して心臓ペーシング療法をさらに実施する埋込可能な医学デバイスに関する。圧反射刺激と心臓ペーシングは連携して起こり、心拍出量を犠牲にせずに血圧を下げることができる。
本主題事項の態様は、難治性の高血圧を持つ患者の全身血圧を下げるために埋込可能なNSデバイスによって使用される圧反射刺激のための方法を含む。プログラム可能な目標に向けて血圧を緩やかに調節するために圧反射刺激アルゴリズムが圧反射刺激を徐々に高める。このアルゴリズムは中枢神経系が圧反射刺激の定常的高レベルに順応する(これは通常、降圧効果を弱める)のを阻止する。さらに、血圧変化の漸進性質は全身血圧と心拍出量の急激な変化を伴なわずに患者はさらに良好に療法に耐えることができる。
心筋梗塞に続いて、梗塞領域の筋細胞が死に、機能性心筋とは異なる機械的特性と伸縮特性を有する傷跡組織で置き換えられる。時間が経つとこの梗塞区域は弱くなって拡張する可能性が高く、心臓全体にわたって心筋緊張の再配分を引き起こす。最終的に、この過程は高度に緊張した領域における損なわれた機械的機能と心不全につながる。高度に緊張した領域は重く「負担をかけられている」と称され、緊張の減少は「負担を取り除く」と称される。急性心筋梗塞を治療して心筋の損傷を阻止または削減するためのデバイスが望ましい。
図26A〜26Bは、モニタされた心臓血管パラメータ(群)に基づいて長時間にわたって望ましい圧反射療法を漸増するために圧反射刺激レベルを自動的に調節するための、本主題事項の様々な実施形態によるシステムと方法を示している。図26Aを参照すると、図示された圧反射刺激装置2650は圧受容器療法の一部として圧受容器刺激を供給するためのパルス発生器2651、圧受容器刺激を変化または変更するためのモジュレータ2652、副交感神経応答のフィードバックを供給するための心臓血管パラメータ・モニタ2653を有する。様々な刺激装置の実施形態が埋込可能である。副交感神経系は2654として図示される。デバイス2650は望ましい神経刺激を与えるための適切な(複数の)電極2655と、神経刺激によって迅速に影響されるパラメータを感知するための(複数の)センサ2656を使用する。そのようなパラメータの例は心拍数、血圧、呼吸を含む。神経刺激に対する副交感神経系の全体的応答の指標であり、迅速で予測可能な応答を有する他の心臓血管パラメータ(群)と代理パラメータ。(複数の)センサと(複数の)電極は単一のリード線に集積化されても、複数のリード線を使用することも可能である。さらに、様々なシステムの実施形態が、異なる、または集積化された埋込可能な心臓律動管理デバイスと通信することができる埋込可能な神経刺激装置を使用して図26Aに図示された機能を実行する。
Claims (20)
- 圧反射刺激を供給するシステムであって、
パルス発生器とモジュレータとを含む圧反射刺激装置であって、前記パルス発生器は、圧反射療法のための間欠的な圧反射刺激を供給するように、反復し連続する刺激サイクルにおいて刺激信号を発生するように動作可能であり、各刺激サイクルは、「刺激あり」の部分と「刺激なし」の部分とを有し、前記モジュレータは、前記刺激信号を調節するように動作可能である、圧反射刺激装置と、
前記圧反射療法の間、少なくとも1つの心臓血管パラメータをモニタし、前記「刺激あり」の部分の間、前記心臓血管パラメータの指標となる第1の信号を供給し、前記「刺激なし」の部分の間、前記心臓血管パラメータの指標となる第2の信号を供給するように動作可能な心臓血管パラメータ・モニタと、
前記第1の信号と前記第2の信号とを比較することによって前記心臓血管パラメータの変化を検出し、前記心臓血管パラメータの目標変化と前記検出された変化とを比較することによって治療制御信号を発生するように動作可能なコンパレータと
を含むシステム。 - 前記モジュレータは、振幅、周波数、バースト周波数、パルス幅、デューティー・サイクルから構成される刺激信号属性の群から少なくとも1つの刺激信号属性を調節するように構成されている、請求項1に記載のシステム。
- 前記心臓血管パラメータ・モニタは、心拍数をモニタするように構成されている、請求項1に記載のシステム。
- 前記心臓血管パラメータ・モニタは、血圧をモニタするように構成されている、請求項1に記載のシステム。
- 前記心臓血管パラメータ・モニタは、呼吸速度をモニタするように構成されている、請求項1に記載のシステム。
- 前記少なくとも1つの心臓血管パラメータは、前記心拍数の増加に伴って増加し、前記心拍数の減少に伴って減少する心拍数の代理パラメータを含む、請求項1に記載のシステム。
- 前記心臓血管パラメータの目標変化は、前記圧反射刺激によって影響を受けるときの前記心臓血管パラメータに関するパーセント変化を含む、請求項1に記載のシステム。
- 前記心臓血管パラメータの目標変化は、前記圧反射刺激によって影響を受けるときの前記心臓血管パラメータに関連付けられた定量的変化を含む、請求項1に記載のシステム。
- 前記心臓血管パラメータは、心拍動であり、前記目標心拍数変化は、プログラム可能な値を含む、請求項1に記載のシステム。
- 前記心臓血管パラメータは、心拍動であり、前記目標心拍数変化は、「刺激なし」の部分の間の心拍数と「刺激あり」の部分の間の心拍数とに基づくパーセント変化を含む、請求項1に記載のシステム。
- 前記心臓血管パラメータは、心拍動であり、前記目標心拍数変化は、前記「刺激なし」の部分の間の心拍数と前記「刺激あり」の部分の間の心拍数とに対する心拍動の数の変化を含む、請求項1に記載のシステム。
- 前記モジュレータは、前記刺激信号の振幅を調節するように構成されている、請求項1に記載のシステム。
- 前記モジュレータは、前記刺激信号の周波数を調節するように構成されている、請求項1に記載のシステム。
- 前記モジュレータは、前記刺激信号のバースト周波数を調節するように構成されている、請求項1に記載のシステム。
- 前記モジュレータは、前記刺激信号のパルス幅を調節するように構成されている、請求項1に記載のシステム。
- 前記モジュレータは、前記刺激信号のデューティー・サイクルを調節するように構成されている、請求項1に記載のシステム。
- 前記モジュレータは、振幅、周波数、バースト周波数、パルス幅、デューティー・サイクルから構成される刺激信号属性の群からの少なくとも2つの刺激信号属性のいずれかの組合せを調節するように構成されている、請求項1に記載のシステム。
- 前記圧反射療法は、心臓組織のリモデリングの阻止と心臓組織の逆方向のリモデリングとのうちの少なくとも1つを含む、請求項1に記載のシステム。
- 埋込可能な神経刺激(NS)デバイスと埋込可能な心臓刺激装置とをさらに含み、前記埋込可能なNSデバイスは、前記圧反射刺激装置を含み、前記埋込可能な心臓刺激装置は、前記心臓血管パラメータ・モニタを含む、請求項1に記載のシステム。
- 埋込可能な神経刺激(NS)デバイスをさらに含み、前記埋込可能なNSデバイスは、前記圧反射刺激装置と前記心臓血管パラメータ・モニタとを含む、請求項1に記載のシステム。
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JP2012020185A (ja) | 2012-02-02 |
US20100106226A1 (en) | 2010-04-29 |
US20130231717A1 (en) | 2013-09-05 |
WO2006031331A1 (en) | 2006-03-23 |
US8805513B2 (en) | 2014-08-12 |
US20140316488A1 (en) | 2014-10-23 |
EP1807150A1 (en) | 2007-07-18 |
US8442640B2 (en) | 2013-05-14 |
US7647114B2 (en) | 2010-01-12 |
US20050143779A1 (en) | 2005-06-30 |
US9440078B2 (en) | 2016-09-13 |
EP1807150B1 (en) | 2017-02-15 |
JP2008512180A (ja) | 2008-04-24 |
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