JP2010508969A - 活動に基づく自動的神経性刺激変調 - Google Patents
活動に基づく自動的神経性刺激変調 Download PDFInfo
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- A61N1/36564—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by blood pressure
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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
- A61N1/365—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
- A61N1/36571—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by blood flow rate, e.g. blood velocity or cardiac output
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37288—Communication to several implantable medical devices within one patient
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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
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Abstract
Description
本願は、米国特許出願第11/558,083号(2006年11月9日出願)に基づく優先権を主張するものであり、この出願は、その全体を参考として本明細書に援用される。
本願は、概して、埋込型医療機器に関し、より具体的には、活動に基づいて神経性刺激を自動的に変調することに関する。
読者が本開示を理解することを補助するために、高血圧症および圧受容器に関する生理機能の簡潔な考察を提供する。この簡潔な考察は、高血圧症、自律神経系、および圧反射を紹介する。
本主題の種々の実施形態は、神経刺激(NS)(例えば、圧反射刺激)機器または部品に関する。神経性刺激は、神経連絡を刺激する、または神経連絡を抑制するために使用することができる。神経連絡を刺激する神経性刺激の一実施例は、低周波数信号(例えば、約20Hzから50Hzまでの範囲内)である。神経連絡を抑制する神経性刺激の一実施例は、高周波数信号(例えば、約120Hzから150Hzまでの範囲内)である。所定の場所に配置される刺激電極を使用して、所望の神経標的に電気刺激パルスを印加する他の実施形態を含む、神経連絡を刺激および抑制するための他の方法が提案されている。加えて、神経を刺激する際に使用するために、超音波、光、または磁気エネルギー等の他のエネルギーの種類が提案されている。本主題の種々の実施形態によれば、交感神経標的は、腓骨神経、脊髄中の交感神経柱、および心臓節後交感神経ニューロンを含むが、それらに限定されない。本主題の種々の実施形態によれば、副交感神経神経標的は、迷走神経、圧受容器、および心臓脂肪体を含むが、それらに限定されない。
システムのNSおよび/またはCRMの機能は、2つの別個で異なる埋込型機器に埋め込まれていても、または部品として1つの埋込型機器に組み込まれていても、NSおよび/またはCRM治療または治療の各部を行うための過程を含む。一部の実施形態では、NS療法は、AHT療法を提供する。一部の実施形態では、神経性刺激療法は、心室再造形を予防および/または治療する。
図16A−16Dは、本主題の種々の実施形態による、神経刺激(NS)機器からの電気刺激と心調律管理(CRM)機器による感知との間の干渉を防ぐシステムおよび方法を図示する。神経性刺激は、信号を感知する能力を改善し、心イベントの検出と関連する偽陽性を排除するように関与する。NS機器は、一部の実施形態ではAHT機器を含む。例えば、NS機器は、一部の実施形態によれば、CRM機器が圧反射刺激に非意図的に反応しないように、通信し、圧反射刺激を予防するか、あるいは補う。一部の実施形態は、圧反射刺激を心臓における適切な屈折と自動的に同期化する。例えば、一部のシステムは、肺動脈の中または周囲の圧受容器の刺激を心房興奮と自動的に同期化する。したがって、圧反射刺激が心臓および心臓の電気的活性化を検出するCRMセンサの近傍で生成された時でさえも、CRM機器の機能は、圧反射刺激によって生成される遠方界の雑音を検出することによって、悪影響を受けない。
本主題の種々の実施形態は、心房興奮を感知し、肺動脈刺激を心房不応期に限定して、近くの心房組織の意図しない刺激を予防する方法に関する。埋込型圧受容器刺激機器は、心房感知リードで心房興奮を監視する。肺動脈中のリードは、血管壁中の圧受容器を刺激する。しかしながら、これらの圧受容器を連続して刺激する代わりに、肺動脈中の圧受容器の刺激は、心房不応期中に発生して近くの心房心筋を捕獲することを回避し、内因性心房レートおよび興奮を維持する。本主題の種々の実施形態は、肺動脈壁中の圧受容器を刺激するための埋込型機器を心房感知のための性能と組み合わせる。種々の実施形態は、心臓脂肪体中の圧受容器、心腔中の圧受容器、および/または求心性神経を刺激する。
交感神経系または副交感神経系の活性化は、ある収縮間隔、主として、心室内の感知された電気的活動(例えば、「R」波の感知)と血液の心室駆出の開始との間の時間間隔である、前駆出期(PEP)を変え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の圧力増加の開始まで測定されてもよいか、または、右心室に位置するか、または左心室に及ぶ電極を使用して、駆出中の心室容積の減少を伴う心内インピーダンスの増加の開始まで測定されてもよい。例えば加速度計で測定される心拍数または身体活動によって判定されるような安静時に、神経性刺激は、事前にプログラムした範囲でPEPを維持するように変調される。PEPの突然の減少は、運動または情緒的ストレスと関連する交感神経の緊張の増加を示す。この状態は、代謝要求を満たすために必要な心拍数および心収縮性の増加を可能にする、神経性刺激を減少させるために使用されてもよい。同様に、PEPの後の劇的な延長は、増加した代謝要求の終了の印となる。この時、神経性刺激による血圧の制御が再開し得る。
本主題は、心拍数、分時換気量、加速度、およびそれらの組み合わせによって判定できるような活動に基づいて、神経性刺激(例えば、圧反射刺激)を自動的に変調する方法を記載する。例えば、圧受容器を電気的に刺激するための機器の機能性は、代謝要求が比較的低い時の安静中に、少なくとも比較的高い圧力ペーシング率で印加し、代謝要求が増加するにつれて、身体運動中に圧力ペーシングを次第に少なくすることによって、強化される。活動の指数は、圧受容器の電気刺激を自動的に変調するために使用され、埋込型神経性刺激機器(例えば、血圧降下機器)が代謝要求の変化に反応することを可能にする。種々の実施形態によれば、ペースメーカー、AICD、またはCRT機器等のCRM機器もまた、神経性刺激リードを有する。機器は、例えば、混合センサを使用して、既存の方法を通して活動を監視する。混合センサは、加速度および分時換気量等のパラメータを測定する2つのセンサを含む。混合センサの出力は、複合パラメータを表す。AHT療法、抗再造形療法、および同等物等の種々の神経性刺激療法は、本開示内で論じられるような2つ以上の感知されたパラメータに由来する、複合パラメータを使用する。安静(より低い活動)時に、機器は、より高い比率で神経性刺激を送達し、血圧を低減して高血圧症を制御する。活動が増加するにつれて、機器は、神経性刺激を一時的に低減または停止することによって反応する。これは、血圧および心拍出量の一時的増加をもたらし、身体が増加した代謝要求に反応することを可能にする。例えば、一部の実施形態は、安静中に圧反射刺激を提供し、運動中に圧反射刺激を撤回して運動への正常な血圧反応に適合する。活動を判定するために、圧力変換器を使用することができる。その上、活動は、比率適応型ペーシングを駆動するために使用される、または使用されてきたセンサを使用して、感知することができる。そのようなセンサの例は、身体の動き、心拍数、QT間隔、呼吸数、経胸腔インピーダンス、1回換気量、分時換気量、体位、脳波図(EEG)、皮下ECGを含む心電図(ECG)、眼電図(EOG)、筋電図(EMG)、筋緊張、体温、パルス酸素濃度、時刻、および心内インピーダンスからの前駆出間隔を検出するセンサを含む。
本主題のある側面は、24時間の期間にわたって発生する血圧の自然変動を模倣するよう、高血圧症患者の圧反射を刺激するための方法に関する。高血圧症の反射低減は、動脈圧の内因性変動を変えずに、長期的圧受容器刺激中に達成される。種々の実施形態によれば、埋込型機器は、例えば、短い高周波数バースト(約20〜150Hzの範囲内の周波数を伴う方形波)を使用して、頸動脈洞、肺動脈、または大動脈弓中の圧受容器を刺激するように設計される。一部の実施形態は、カフ電極で、頸動脈洞神経、大動脈神経、または迷走神経を直接刺激する。しかしながら、バーストは一定の比率で発生しない。むしろ、刺激周波数、振幅、および/またはバースト周波数は、日中に昇降して、自然な概日リズムを模倣する。
本主題のある側面は、圧反射を刺激することによって全身血圧を低減するNS療法を提供し、さらに、心拍数制御のために心臓ペーシングリードを使用して心臓ペーシング療法を提供する、埋込型医療機器に関する。圧反射刺激および心臓ペーシングは、提携して発生し、心拍出量を犠牲にすることなく、血圧が低下されることを可能にする。
本主題の側面は、埋込型NS機器によって使用される、不応性高血圧症患者の全身血圧を低下させる、圧反射刺激のための方法を伴う。圧反射刺激アルゴリズムは、圧反射刺激を徐々に増加させて、プログラム可能な標的に向けて血圧をゆっくりと調整する。このアルゴリズムは、通常は圧力低下作用を減衰させる、一定の増加したレベルの圧反射刺激に中枢神経系が適応することを防ぐ。また、血圧変化の漸進的性質は、全身血圧および心拍出量の急変を伴わずに、患者が治療により良く耐えることを可能にする。
心筋梗塞後、梗塞領域中の筋細胞は死んで、機能的心筋とは異なる機械的および弾性特性を有する、瘢痕組織に代替される。経時的に、この梗塞領域は菲薄化および拡大し得て、心臓全体にわたって心筋ストレスの再配分を引き起こす。最終的に、この過程は、高応力下の領域中の機械的機能の低下、および心不全につながる。高応力下の領域は、高「負荷」であると呼ばれ、応力の低減は、「無負荷」と称される。急性心筋梗塞を治療して、心筋損傷を予防または低減する機器が望ましい。
Claims (35)
- 神経性刺激を提供するシステムであって、
活動を感知し、該活動を示す信号を提供する、活動モニタと、
神経刺激装置であって、
神経性刺激療法を提供するように適合される神経性刺激信号を提供する、パルス発生器と、
該活動を示す該信号を受信し、該活動を示す該信号に基づいて該神経性刺激信号を変調して該神経性刺激療法を変更する、変調器と
を含む、神経刺激装置と
を備える、システム。 - 前記活動モニタは、安静と運動とを区別するための、少なくとも1つの信号を提供するように適合され、前記パルス発生器と前記変調器とは、恊働して、前記神経性刺激信号を提供することによって安静に反応するように、かつ該神経性刺激信号を撤回することによって運動に反応するように適合される、請求項1に記載のシステム。
- 前記活動を示す前記信号は、活動レベルを示す信号を含み、前記変調器は、該活動レベルに基づいて神経性刺激レベルを設定するように適合される、請求項1に記載のシステム。
- 前記変調器は、少なくとも1つの感知された活動パラメータを少なくとも1つの参照パラメータと比較し、該比較の結果に基づいて前記神経性刺激信号を変調するように適合される、請求項1に記載のシステム。
- 前記変調器は、前記少なくとも1つの参照パラメータと前記少なくとも1つの感知された活動パラメータの差異を判定し、該差異に基づいて前記神経性刺激を変調するように適合される、請求項4に記載のシステム。
- 前記変調器は、前記差異に比例して前記神経性刺激の強度を変更するように適合される、請求項5に記載のシステム。
- 前記変調器は、一定の期間にわたる感知された活動に基づいて、前記少なくとも1つの参照パラメータを動的に調整するように適合される、請求項5に記載のシステム。
- 前記パルス発生器と前記変調器とは、前記感知された活動が閾値を下回るときに、前記神経性刺激信号を提供し、該感知された活動が該閾値を上回るときに、該神経性刺激信号を与えずにおくように適合される、請求項1に記載のシステム。
- 前記感知された活動は、意図的でない生理学的反応と関連し、前記パルス発生器と前記変調器とは、前記神経性刺激を調整して該意図的でない反応を軽減するように適合される、請求項1に記載のシステム。
- 前記刺激信号は、振幅を有し、前記変調器は、前記活動を示す前記信号に基づいて該振幅を変調する変調器を含む、請求項1に記載のシステム。
- 前記刺激信号は、周波数を有し、前記変調器は、前記活動を示す前記信号に基づいて該周波数を変調する変調器を含む、請求項1に記載のシステム。
- 前記パルス発生器は、神経性刺激パルス列を生成するように適合され、前記変調器は、神経性刺激パルス列の継続時間を変更する変調器を含む、請求項1に記載のシステム。
- 前記活動モニタは、心拍数センサを含む、請求項1に記載のシステム。
- 前記活動モニタは、呼吸モニタを含む、請求項1に記載のシステム。
- 前記呼吸モニタは、分時換気量モニタを含む、請求項14に記載のシステム。
- 前記呼吸モニタは、呼吸数モニタを含む、請求項14に記載のシステム。
- 前記活動モニタは、動作モニタを含む、請求項1に記載のシステム。
- 前記動作モニタは、加速度計を含む、請求項17に記載のシステム。
- 前記動作モニタは、筋肉の動きを評価するために筋電図法(EMG)を使用するように適合される、請求項17に記載のシステム。
- 前記動作モニタは、グローバルポジショニングシステム(GPS)技術を使用するように適合される、請求項17に記載のシステム。
- 前記活動モニタは、1回拍出量モニタを含む、請求項1に記載のシステム。
- 前記活動モニタは、1回呼吸量モニタを含む、請求項1に記載のシステム。
- 前記活動モニタは、神経活動のモニタを含む、請求項1に記載のシステム。
- 前記活動モニタは、心拍出量のモニタを含む、請求項1に記載のシステム。
- 前記活動モニタは、少なくとも1つの血圧パラメータを感知するセンサを含む、請求項1に記載のシステム。
- 前記少なくとも1つの血圧パラメータは、平均動脈圧、脈圧、収縮末期圧、または拡張末期圧を含む、請求項25に記載のシステム。
- 前記活動モニタは、少なくとも1つの電位図測定値を測定するモニタを含む、請求項1に記載のシステム。
- 埋込型医療機器をさらに備え、該埋込型医療機器は、前記活動モニタおよび前記神経刺激装置を含む、請求項1に記載のシステム。
- 埋込型神経刺激(NS)機器と、埋込型心臓刺激装置とをさらに備え、該埋込型NS機器は、前記神経刺激装置を含み、該埋込型心臓刺激装置は、前記活動モニタを含む、請求項1に記載のシステム。
- 前記変調器は、概日リズムに基づいて、および前記活動を示す前記信号に基づいて、前記神経性刺激信号を変調して前記神経性刺激療法を変更するように適合される、請求項1に記載のシステム。
- 前記変調器は、日中は、増加した活動によって神経性刺激強度をより積極的に低減するが、夜間は、増加した活動によって神経性刺激をあまり積極的に低減しないように適合される、請求項30に記載のシステム。
- 神経刺激装置であって、
神経性刺激療法を提供するように適合される神経性刺激信号を提供する、埋込型パルス発生器と、
該神経性刺激療法の強度を変更するために、活動を示す信号に基づいて該神経性刺激信号を変調する、手段と
を備える、装置。 - 前記神経性刺激信号を変調する前記手段は、活動レベルを検出する手段と、該活動レベルに基づいて該神経性刺激信号を変調する手段とを含む、請求項32に記載の神経刺激装置。
- 前記神経性刺激信号を変調する前記手段は、前記活動を示す信号が閾値未満である場合にだけ神経性刺激を印加する手段を含む、請求項32に記載の神経刺激装置。
- 前記神経性刺激信号を変調する前記手段は、概日リズムに基づいて、および前記活動を示す信号に基づいて、該神経性刺激信号を変調する手段を含む、請求項32に記載の神経刺激装置。
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US20150032188A1 (en) | 2015-01-29 |
EP2089104A1 (en) | 2009-08-19 |
US20110082514A1 (en) | 2011-04-07 |
JP5502957B2 (ja) | 2014-05-28 |
JP2012236083A (ja) | 2012-12-06 |
US20190366095A1 (en) | 2019-12-05 |
US8874211B2 (en) | 2014-10-28 |
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