JP5147719B2 - 血管内−血管外の接近路を経てパルス電界神経変調を行うための方法及び装置 - Google Patents
血管内−血管外の接近路を経てパルス電界神経変調を行うための方法及び装置 Download PDFInfo
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Description
本発明は、神経変調、例えば、除神経を行うための方法及び装置に係る。より詳細には、本発明は、血管内−血管外接近路を経てパルス電界神経変調を達成するための方法及び装置に係る。幾つかの実施形態では、ITEV PEFシステムは、患者の血管壁を横切ってターゲット神経線維の付近へと血管内−血管外配置するように構成された1つ以上の電極を有する血管内カテーテルを備えている。PEFを付与する前に血管内位置から血管外位置へと電極(1つ又は複数)が通過する状態で、電極を経て付与されて希望の神経変調を達成するのに必要な印加電圧又はエネルギーの大きさを、1つ以上の電極が血管内のみに位置された血管内PEFシステムに対して減少することができる。本発明の方法及び装置は、例えば、腎臓機能に貢献する1つ以上のターゲット神経線維を変調するのに使用できる。
図1を参照すると、人間の腎臓の解剖学的構造は、腹部の大動脈AAにより心臓に接続された腎臓動脈RAによって酸素付加血液が供給される腎臓Kを含む。酸素除去血液は、腎臓から、腎臓静脈RV及び下大静脈IVCを経て心臓へ流れ込む。図2は、腎臓の解剖学的構造の一部分を詳細に示す。より詳細には、腎臓の解剖学的構造は、一般的に動脈の外膜内で腎臓動脈RAの長さ次元Lに沿って長手方向に延びる腎臓神経RNも含む。腎臓動脈RAは、動脈の角度軸θの周りの動脈周囲及び螺旋部を取り巻く滑らかな筋肉細胞SMCを有する。従って、腎臓動脈の滑らかな筋肉細胞は、その長さ又は長手次元が、腎臓動脈の長さ次元を横断して(即ち、非平行に)延びる。腎臓神経及び滑らかな筋肉細胞の長さ次元の不整列は、「細胞不整列」として定義される。
図4を参照して、本発明の血管内−血管外(ITEV)PEFシステム及び方法の実施形態を説明する。本発明のITEV PEFシステムは、1つ以上の電極を一時的に血管内に配置しそして血管の壁を横切って血管外に配置するように構成される。更に、このシステムは、神経変調のために神経線維にパルス電界を付与するように構成される。1つの特定例では、システムは、腎臓機能に貢献する神経線維にパルス電界を付与し、腎臓神経変調を達成するように構成される。本発明の説明上、血管外とは、血管の内膜及び中膜層に対して外部の位置を指す。血管外とは、例えば、血管の外膜内又は周囲の脂肪組織内の位置を含んでもよい。
Claims (30)
- 血管内−血管外の接近路を経て電界神経変調を行う装置において、
電界ジェネレータと、
前記電界ジェネレータに電気的に結合され、血管内に送り込んで血管内−血管外の接近路を経て血管外に配置するように構成された少なくとも1つの電極と、
を備え、前記電極は、電界を血管外に付与し、腎機能に寄与する1または2以上の目標神経線維を変調するように構成されたものである、
ことを特徴とする装置。 - 前記電極は、第1電極及び第2電極を有する少なくとも1つの双極電極対を含み、この双極電極対は、前記電界ジェネレータに結合される、
請求項1に記載の装置。 - 前記第1電極は、血管内−血管外の接近路を経て血管外に配置されるように構成され、そして前記第2電極は、血管内に配置されるように構成される、
請求項2に記載の装置。 - 前記第1電極は能動的な電極であり、そして前記第2電極は戻り電極である、
請求項3に記載の装置。 - 前記第1電極及び第2電極は、両方とも、血管内−血管外の接近路を経て血管外に配置されるように構成される、
請求項2に記載の装置。 - 前記第1電極及び第2電極は、その配備構成において互いに長手方向に離間される、
請求項2に記載の装置。 - 前記第1電極及び第2電極は、患者の血管の周囲に対して互いに角度的に整列される、
請求項2に記載の装置。 - 外部接地パッドを更に備え、前記電極は、パルス電界の単極血管外付与を行って、神経変調を誘起するように構成される、
請求項1に記載の装置。 - 血管内に送り込むように構成された突き刺し要素を更に備え、この突き刺し要素は、血管内から患者の血管壁を突き刺すように構成される、
請求項1に記載の装置。 - 前記電極は、突き刺し要素を含む、
請求項9に記載の装置。 - 前記突き刺し要素は、ニードル又はカニューレを含む、
請求項9に記載の装置。 - 前記電極は、前記ニードルの内腔を通して血管外に配置されるように構成される、
請求項11に記載の装置。 - 前記電極は、カテーテルに結合される、
請求項1に記載の装置。 - 前記電極は、前記カテーテルの膨張可能な要素に結合される、
請求項13に記載の装置。 - 前記電極は、目標腎繊維の壊死を介して神経変調を誘起させるように構成される、
請求項1に記載の装置。 - 前記装置は、薬剤を血管外に注ぐように構成される、
請求項1に記載の装置。 - 電界神経変調を行う装置において、
電界ジェネレータと、
患者の血管構造体内を移動するように構成された細長い要素と、
前記細長い要素に関連した血管内部分と、血管構造体の壁を貫通するように構成された血管外部分とを有する少なくとも1つの電極であって、前記電界ジェネレータに電気的に結合される電極と、
前記電極に関連したアクチュエータであって、前記電極の血管外部分が血管構造体内にある第1位置から、前記電極の血管外部分が電界の血管外付与のために血管外位置に配置される第2位置へと前記電極を移動させ腎機能に寄与する1または2以上の目標神経線維を調整するように構成されたアクチュエータと、を備えている、
ことを特徴とする装置。 - 前記電極は、第1電極及び第2電極を有する少なくとも1つの双極電極対を含み、この双極電極対は、前記電界ジェネレータに結合される、
請求項17に記載の装置。 - 前記電極の血管外部分は、双極電極対を含む、
請求項18に記載の装置。 - 前記電極の血管内部分は、前記双極電極対の第1電極を含み、そして前記電極の血管外部分は、前記双極電極対の第2電極を含む、
請求項18に記載の装置。 - 前記第1電極及び第2電極は、前記第2の位置において互いに長手方向に離間される、
請求項18に記載の装置。 - 外部接地パッドを更に備え、前記電極の血管外部分は、電界の単極血管外付与を行うように構成される、
請求項17に記載の装置。 - 前記アクチュエータは、前記電極の血管外部分を前記第1位置から第2位置へ移動する間に血管構造の壁を突き刺すように構成された突き刺し要素を含む、
請求項17に記載の装置。 - 前記電極の血管外部分は、前記電極の血管外部分を前記第1位置から第2位置へ移動する間に血管構造の壁を突き刺すように構成された突き刺し要素を含む、
請求項17に記載の装置。 - 注入剤を更に備え、前記装置は、前記注入剤を血管外に注入するように構成される、
請求項17に記載の装置。 - 前記注入剤は、神経変調向上注入剤又は保護注入剤を含む、
請求項25に記載の装置。 - 前記アクチュエータは、膨らまし得るバルーンを含む、
請求項17に記載の装置。 - 前記アクチュエータは、膨張可能なかご又はおりを含む、
請求項17に記載の装置。 - 前記アクチュエータは、前記電極の血管外部分が前記第1位置から第2位置へ移動されるときに前記電極の血管外部分を半径方向外方に向けるように構成されたプロフィールをもつ移行要素を含む、
請求項17に記載の装置。 - 電界神経変調を行う装置において、
電界ジェネレータと、
第1及び第2電極を有する双極電極対であって、前記パルス電界ジェネレータに電気的に結合された双極電極対と、
アクチュエータを有するカテーテルと、
を備え、前記カテーテルは、前記双極電極対を患者の血管構造体内に位置させるよう構成され、
前記アクチュエータは、前記双極電極対の非絶縁部分を、前記血管構造体内の位置から血管外位置へと一時的に移動し双極電界を血管外に付与し、腎機能に寄与する1または2以上の神経線維を変調するように構成された、
ことを特徴とする装置。
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US11/363,867 US7620451B2 (en) | 2005-12-29 | 2006-02-27 | Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach |
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CN101426551B (zh) | 2016-01-20 |
EP2656873B1 (en) | 2016-04-06 |
US20110202098A1 (en) | 2011-08-18 |
EP3173123A1 (en) | 2017-05-31 |
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WO2007078997A3 (en) | 2008-10-23 |
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CA2633666A1 (en) | 2007-07-12 |
EP1968692A4 (en) | 2010-03-10 |
US8958871B2 (en) | 2015-02-17 |
EP2656874B1 (en) | 2016-11-16 |
JP2009521993A (ja) | 2009-06-11 |
CA2633666C (en) | 2016-09-20 |
EP2664355A1 (en) | 2013-11-20 |
EP2656874A2 (en) | 2013-10-30 |
US10039596B2 (en) | 2018-08-07 |
US20170014178A1 (en) | 2017-01-19 |
EP2656874A3 (en) | 2013-11-27 |
CN105288847A (zh) | 2016-02-03 |
US9364280B2 (en) | 2016-06-14 |
US20150164583A1 (en) | 2015-06-18 |
US20100057150A1 (en) | 2010-03-04 |
WO2007078997A2 (en) | 2007-07-12 |
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