JP2022501112A - 心内膜組織へのパルス電界アブレーションエネルギーの送達のためのシステム、装置、および方法 - Google Patents
心内膜組織へのパルス電界アブレーションエネルギーの送達のためのシステム、装置、および方法 Download PDFInfo
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Abstract
Description
本出願は、2018年9月20日に出願された米国仮出願第62/734,214号の利益を主張するものであり、その開示全体は、参照によりその全体が本明細書に組み込まれる。
概要
本明細書において、組織アブレーショを補助し、不可逆的電気穿孔をもたらするための、電圧パルス波形の選択的かつ迅速な印加を介した組織アブレーションのために構成されたシステムおよびデバイスが開示される。概して、本明細書に記載される組織を切除するためのシステムは、電気穿孔を駆動するためのDC電圧の選択的かつ迅速な印加のための、1つ以上の電極および拡張可能/膨張可能な部材(例えば、バルーン)を有する信号発生器およびアブレーションデバイスを含んでもよい。本明細書に記載されるように、システムおよびデバイスは、心内膜で展開されて、心不整脈を治療し得る。電圧パルス波形は、適切なアノード/カソード電極の選択を伴い、電極のサブセットに印加され得る。心刺激のためのペーシング信号は、ペーシング信号と同期して信号発生器によってパルス波形を発生させるために発生し、使用され得る。
本明細書に記載されるシステムは、不整脈などの兆候を治療するために、心臓の肺静脈の組織を切除するように構成された1つ以上の多電極アブレーションデバイスを含んでもよい。図2Aは、内腔を画定する第1のカテーテル(203)(例えば、カテーテルシャフトまたは外側シャフト)と、第2のカテーテル(210)(例えば、内腔を画定する管状ガイドワイヤまたは内側シャフト)と、膨張可能な部材(207)とを含むアブレーションデバイス(200)(例えば、アブレーションデバイス(110)と構造的および/または機能的に類似)の側面図である。第2のカテーテル(210)は、第1のカテーテル(203)の内腔内、および第2のカテーテル(210)が第1のカテーテル(203)に対して摺動可能であり得る膨張可能な部材(207)のチャンバ内に配置されてもよい。膨張可能な部材(例えば、バルーン)(207)は、第2のカテーテルが膨張可能な部材(207)の内側チャンバを通過し得るように、第2のカテーテル(210)に連結されてもよい。第1の電極(213)は、第1のカテーテル(203)の遠位部分(217)の表面上に配置されてもよく、膨張可能な部材(207)の近位部分から分離されるか、あるいはそれに取り付けられてもよい。第2の電極(220)は、第2のカテーテル(210)の遠位部分(223)上に配置されてもよく、膨張可能な部材(207)の遠位部分から分離されるか、あるいはそれに取り付けられてもよい。第2のカテーテル(217)の遠位部分(223)は、直線的に移動可能であり、第1のカテーテル(203)の遠位部分の周囲にあり得る。いくつかの実施形態では、第2の電極(223)は、第1の電極(213)に対して移動可能であってもよい。膨張可能な部材(207)の近位部分は、第1のカテーテル(203)の遠位部分に連結されてもよい。
また、本明細書において、上記のシステムおよびデバイスを使用して肺静脈(例えば、左心房の肺静脈)内の組織を切除するための方法も記載される。概して、本明細書に記載される方法は、デバイスを肺静脈口に導入および配置することを含む。パルス波形は、デバイスの1つ以上の電極および膨張可能な部材(例えば、バルーン)によって送達されて、組織を切除し得る。いくつかの実施形態では、心臓ペーシング信号は、送達されたパルス波形を心周期と同期させ得る。追加的または代替的に、パルス波形は、総エネルギー送達を低減するための複数の階層レベルを含んでもよい。実施される組織切除は、したがって、健康な組織の損傷を低減するために、ペーシングされた心拍と同期して、かつより少ないエネルギー送達で送達され得る。本明細書に記載されるアブレーションデバイスのいずれかを使用して、必要に応じて以下で考察される方法を使用して組織を切除し得ることが理解されるべきである。
本明細書において、不可逆的電気穿孔を伴う組織アブレーションをもたらすための、パルス電界/波形の選択的かつ迅速な印加のための方法、システム、および装置が開示される。本明細書に開示されるパルス波形(複数可)は、本明細書に記載されるシステム(100)、デバイス(例えば、200、300、400、500、600、700、800、900)、および方法(例えば、1600)のいずれかで使用可能である。いくつかの実施形態は、電極のセットを介して組織にエネルギーを送達するための順序付けられた送達スキームとともに、パルス高電圧波形に関する。いくつかの実施形態では、ピーク電界値が低減および/または最小化され得ると同時に、十分に大きい電界の大きさが、組織アブレーションが望まれる領域で維持され得る。いくつかの実施形態では、不可逆的電気穿孔に有用なシステムは、信号発生器と、アブレーションデバイスの電極の選択された複数またはサブセットにパルス電圧波形を印加するように構成され得るプロセッサとを含む。いくつかの実施形態では、プロセッサは、入力を制御するように構成され、それによって、電極のアノード−カソードサブセットの選択された対は、所定のシーケンスに基づいて同時または順次のいずれかでトリガされ得、一実施形態では、順序付けられた送達は、心臓刺激装置および/またはペーシングデバイスからトリガされ得る。いくつかの実施形態では、アブレーションパルス波形は、心臓の洞調律の乱れを回避するために、心周期の不応期中に印加され得る。これを実施する方法の一例は、心臓刺激装置を用いて心臓を電気的にペーシングし、心周期の周期性および予測可能性を確立するためにペーシング捕捉を確実にし、次いで、アブレーション波形が送達されるこの周期サイクルの不応期の十分範囲内に時間窓を定義することである。
Claims (27)
- 長手方向軸を有し、内腔を画定する第1のシャフトと、
前記内腔内に配置され、前記第1のシャフトの遠位部分から延在する遠位部分を有する第2のシャフトであって、前記第2のシャフトが、前記第1のシャフトに対して前記長手方向軸に沿って移動可能な、第2のシャフトと、
前記第1のシャフトの前記遠位部分に連結された第1の電極と、
前記第2のシャフトの前記遠位部分に連結された第2の電極であって、前記第1および第2の電極が、組織を切除するための電界を発生させるように構成されている、第2の電極と、
前記第1の電極と前記第2の電極との間に配置された膨張可能な部材であって、前記膨張可能な部材が、前記第1のシャフトに対して近位に移動している前記第2のシャフトに応答して、非展開構成から展開構成に移行するように構成され、前記展開構成の前記膨張可能な部材が、肺静脈口の壁に係合し、前記第1および第2の電極によって発生する前記電界を前記壁に向けるように構成されている、膨張可能な部材と、を備える、装置。 - 前記膨張可能な部材が、壁であって、
近位部分と、
遠位部分と、
前記壁の前記近位部分と前記遠位部分との間に配置された中間部分であって、前記中間部分が、前記壁の前記近位および遠位部分の厚さよりも小さい最小厚さを有する、中間部分と、を有する壁を含む、請求項1に記載の装置。 - 前記長手方向軸に沿った前記膨張可能な部材の前記近位および遠位部分の各々の長さが、前記長手方向軸に沿った前記中間部分の長さよりも大きい、請求項2に記載の装置。
- 長手方向軸を有し、内腔を画定するシャフトと、
前記シャフトの遠位部分の近くに配置された膨張可能な部材であって、前記膨張可能な部材が、非展開構成と展開構成との間を移行するように構成され、前記膨張可能な部材が、壁であって、近位部分、遠位部分、および前記壁の前記近位部分と遠位部分との間に配置された中間部分を有する壁を含み、前記中間部分が、前記壁の前記近位および遠位部分の厚さよりも小さい最小厚さを有する、膨張可能な部材と、
前記長手方向軸に沿って前記膨張可能な部材の反対側に配置された第1および第2の電極であって、前記第1の電極および第2の電極が、組織を切除するための電界を発生させるように構成されている、第1の電極および第2の電極と、を備える、装置。 - 前記展開構成の前記膨張可能な部材が、肺静脈口の壁に係合するよう構成され、前記展開構成の前記膨張可能な部材が、前記第1および第2の電極によって発生する前記電界を前記肺静脈口の前記壁に向けるように、前記拡張可能な部材が絶縁材料から形成される、請求項4に記載の装置。
- 前記展開構成の前記膨張可能な部材が、前記長手方向軸に対して約45度超角度の付いた少なくとも近位部分または遠位部分を含む、請求項1〜5のいずれか一項に記載の装置。
- 前記中間部分の前記最小厚さが、前記壁の少なくとも前記近位部分または遠位部分の前記厚さの約3分の1未満である、請求項3または4のいずれか一項に記載の装置。
- 前記中間部分の前記長さに対する前記近位部分の前記長さの比、および前記中間部分の前記長さに対する前記遠位部分の前記長さの比が、約3よりも大きい、請求項2〜5または7のいずれか一項に記載の装置。
- 前記展開構成の前記膨張可能な部材が、約40mm未満の幅、約25mm未満の高さ、および約15mm未満の曲率半径を有する側面部分を有する、断面形状を有する、請求項1〜8のいずれか一項に記載の装置。
- 前記展開構成の前記膨張可能な部材が、約20mm〜約40mmの最大幅を有する断面形状を有する、請求項1〜9のいずれか一項に記載の装置。
- 前記第1の電極が、前記膨張可能な部材の近位部分に取り付けられ、前記第2の電極が、前記膨張可能な部材の遠位部分に取り付けられている、請求項1〜10のいずれか一項に記載の装置。
- 前記第1および第2の電極の各々が、約1mm〜7mmの外径、および約1mm〜約15mmの前記長手方向軸に沿った長さを有する、請求項1〜11のいずれか一項に記載の装置。
- 前記第2の電極が、円形遠位端を有する、請求項1〜12のいずれか一項に記載の装置。
- 前記長手方向軸に沿った前記膨張可能な部材の前記近位および遠位部分の各々の長さが、前記長手方向軸に沿った前記中間部分の長さよりも大きい、請求項2〜5または7のいずれか一項に記載の装置。
- 前記膨張可能な部材が、注入デバイスに流体連結され、前記膨張可能な部材が、前記注入デバイスからの流体の注入に応答して、前記非展開構成から前記展開の構成に移行するように構成されている、請求項1〜14のいずれか一項に記載の装置。
- 前記流体の注入が、約2psi〜約20psiの注入圧力で送達される、請求項15に記載の装置。
- パルス波形を発生させるように構成された信号発生器と、
前記信号発生器に連結されたアブレーションデバイスであって、前記アブレーションデバイスが、
前記パルス波形を受信し、アブレーションのための電界を発生させるように構成された第1および第2の電極、ならびに
絶縁材料から形成され、前記第1の電極と前記第2の電極との間に配置された膨張可能な部材であって、前記膨張可能な部材が、前記膨張可能な部材が肺静脈口に前進することができる非展開構成と、前記膨張可能な部材が前記肺静脈口の壁と係合することができる展開構成との間を移行するように構成され、前記展開構成の前記膨張可能な部材が、前記電界を前記壁に向けるように構成されている、膨張可能な部材、を含むアブレーションデバイスと、を備える、システム。 - 前記アブレーションデバイスが、
長手方向軸を有し、内腔を画定する第1のシャフトと、
前記内腔を通って延在する第2のシャフトであって、前記第2のシャフトが、前記長手方向軸に沿った前記膨張可能な部材の近位端および遠位端を互いに近づけて、前記膨張可能な部材を前記非展開状態から前記展開状態に移行させるように、前記第1のシャフトに対して移動可能である、第2のシャフトと、をさらに含む、請求項17に記載のシステム。 - 前記アブレーションデバイスの近位部分に連結されたハンドルをさらに備え、前記ハンドルが、前記第1のシャフトに対して前記第2のシャフトを移動させるように構成された機構を含む、請求項18に記載のシステム。
- 前記ハンドルが、前記第1のシャフトに対する前記第2のシャフトの位置をロックして、前記膨張可能な部材を前記展開構成に維持するように構成されたロック機構をさらに含む、請求項19に記載のシステム。
- 前記膨張可能な部材を加圧して、前記膨張可能な部材を前記非展開構成から前記展開構成に移行させるように構成された注入デバイスをさらに備える、請求項17〜20のいずれか一項に記載のシステム。
- 前記展開構成の前記膨張可能な部材が、約40mm未満の幅、約25mm未満の高さ、および約15mm未満の曲率半径を有する側面部分を有する、断面形状を有する、請求項17〜21のいずれか一項に記載のシステム。
- アブレーションデバイスの外側シャフトに対して前記アブレーションデバイスの内側シャフトを格納することであって、前記内側シャフトが、前記外側シャフトの内腔内に配置されている、格納することと、
前記外側シャフトに対して前記内側シャフトを格納することに応答して、前記アブレーションデバイスの膨張可能な部材を、非展開構成から、前記膨張可能な部材の側面部分が肺静脈口の壁に係合する展開構成に移行させることと、
前記移行後に、前記アブレーションデバイスの第1および第2の電極にパルス波形を送達して、これにより、前記第1および第2の電極が、前記肺静脈口の前記壁を切除するための電界を発生させることであって、前記第1および第2の電極が、前記膨張可能な部材の反対側に配置されている、送達することと、を含む、方法。 - 前記膨張可能な部材が、前記第1および第2の電極によって発生する前記電界を前記肺静脈口の前記壁に向けるために構成されるように、前記拡張可能な部材が絶縁材料から形成される、請求項23に記載の方法。
- 前記格納後に、前記アブレーションデバイスのロック機構を使用して、前記外側シャフトに対する前記内側シャフトの位置をロックすることをさらに含む、請求項23または24のいずれか一項に記載の方法。
- 前記格納前に、前記内側シャフトの一部分を偏向させて、前記膨張可能な部材を前記肺静脈口内に位置付けることをさらに含む、請求項23〜25のいずれか一項に記載の方法。
- 前記膨張可能な部材に流体を注入することをさらに含む、請求項23〜26のいずれか一項に記載の方法。
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EP3852661A1 (en) | 2021-07-28 |
CN112955088A (zh) | 2021-06-11 |
US10687892B2 (en) | 2020-06-23 |
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