JP5759615B2 - 腎交感神経の除神経およびイオン導入薬物送達のためのイオン導入カテーテルシステムならびに方法 - Google Patents
腎交感神経の除神経およびイオン導入薬物送達のためのイオン導入カテーテルシステムならびに方法 Download PDFInfo
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Description
本開示は、腎臓除神経および血管内薬物送達に関する。より具体的には、本開示は、腎交感神経の除神経およびイオン導入薬物送達のためのイオン導入カテーテルシステムならびに方法に関する。
慢性的血圧上昇、すなわち、高血圧は、心臓病および死亡の有意な原因であって、世界中で数百万人を苦しめている。概して、１４０ｍｍＨｇ収縮期および９０ｍｍＨｇ拡張期を超える慢性的血圧を有する人は、高血圧に罹患していると分類される。腎交感神経活性が、血圧の上昇を引き起こし、持続させると考えられている。腎神経は、腎動脈の周囲に結束されており、大腿動脈を介して、容易にアクセス可能である。腎臓除神経は、血圧を低下させることが分かっている。
高血圧の治療のための腎臓除神経の従来の方法には、いくつかの不利点がある。従来の方法は、腎動脈のいくつかの離散部位への高熱の印加を伴い、これは、患者にとって、非常に痛みを伴うものであって、回復時間を増加させ得る。加えて、高熱の印加は、流動を制限する狭窄をもたらし得る。別の不利点は、動脈壁内の神経束の正確な場所が分からないことに関わる。したがって、複数の部位が、腎神経機能が減衰されるであろう確率を増加させるために治療されなければならない。
別の不利点として、治療の間、血管壁との並置を維持する際の困難が挙げられる。また、従来の腎臓除神経治療システムおよび方法は、各部位の治療後、カテーテルを縦方向に移動させ、カテーテルを回転させ、流動を制限する狭窄の生成を回避する。したがって、従来の腎神経除神経システムおよび方法の不利点を克服する、腎神経の除神経のためのシステムおよび方法は、歓迎すべき進展となるであろう。
本開示によると、腎交感神経の除神経およびイオン導入薬物送達のためのイオン導入薬物送達システムならびに方法が提供される。本システムは、患者内に介入的に配置されるように構成されるイオン導入カテーテルを含む。ある実施形態では、イオン導入カテーテルは、下行大動脈および／または腎臓に隣接する１つ以上の腎動脈分岐間の腎動脈の管腔内に配置されるように構成される。薬物送達カテーテルは、その遠位先端または端部の近傍に、膨張されると、血管壁に円周全体に接触するバルーンを含む。
１つ以上の電極が、バルーンの表面に関連付けられ、いくつかの実施形態では、電極は、バルーンの外側表面上に配置される。電極は、エネルギー源に動作可能に連結される。エネルギー源は、２つのバルーン電極間（例えば、双極モード）、および／または１つのバルーン電極と、限定ではないが、皮膚、血管等の患者の身体の一部に接触して配置される別の電極との間（例えば、単極モード）に双極または単極電場を発生させるように構成される。エネルギー源は、エネルギー送達を調整かつ監視し、および／または関連パラメータ（組織インピーダンス、接触温度、組織温度、および同等物）を監視するように構成される、制御システムを含み得る。いくつかの実施形態では、エネルギー源は、一定電流である直流（ＤＣ）エネルギーを提供する。
電場は、連続またはパルス直流であり得る。使用の間、開示されるカテーテルは、隣接する組織（例えば、血管壁、神経、および周囲組織）内に電位勾配を発生させ、ひいては、薬物のイオン導入送達を促進する。
開示されるカテーテルはまた、標的組織に送達されるべき１つ以上の薬物の格納部を含むことができる。本開示による実施形態では、薬物は、バルーンの外側表面上にコーティングとして提供されることができる。本開示によるいくつかの実施形態では、バルーンは、バルーン管腔への薬物の投与が、電極に隣接するバルーンの外側表面へのその輸送を生じさせるように、穿孔される（例えば、浸出バルーン）。
本開示によるいくつかの実施形態では、薬物は、バルーンの外側表面に関連付けられたウェル内に提供される。ウェルは、バルーンが、膨張されると、破裂され、それによって、ウェルの内側の薬物を電極の近傍に放出させる被覆層で被覆される。１つ以上の薬物をバルーンの外側表面に提供するための他の実施形態も、本開示の教示内で想定される。したがって、本明細書に説明される方法は、例示的方法として提供され、限定として解釈されない。
本開示のある側面によると、イオン導入薬物送達システムが提供される。本システムは、エネルギー源と、カテーテルと、カテーテルの遠位端に配置されるバルーンと、バルーンの表面上に配置され、エネルギー源に動作可能に連結される少なくとも１つの電極と、バルーンに動作可能に関連付けられた薬物供給部とを含む。薬物供給部は、薬物を選択的に放出するように構成される。薬物供給部は、少なくとも１つの薬物を含む。少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される。エネルギー源は、少なくとも１つの電極に直流電流を送達するように構成される。
いくつかの実施形態では、バルーンの外側表面は、薬物供給部を格納するための少なくとも１つのウェルを含む。少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む。
いくつかの実施形態では、バルーンは、バルーンの内部と流体連通する複数の穿孔を含む。
いくつかの実施形態では、薬物供給部は、バルーンの外側表面上に提供されているコーティングである。
本開示の別の側面によると、イオン導入薬物送達システムが提供される。本システムは、エネルギー源と、カテーテルと、カテーテルの遠位端に配置される拡張可能部材と、拡張可能部材上に配置され、エネルギー源に動作可能に連結される、少なくとも１つの電極と、拡張可能部材に動作可能に関連付けられた薬物供給部とを含む。薬物供給部は、薬物を選択的に放出するように構成される。薬物供給部は、少なくとも１つの薬物を含む。少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される。エネルギー源は、少なくとも１つの電極に直流電流を送達するように構成される。
拡張可能部材は、バルーンおよびフレームから成る群から選択される。バルーンの外側表面は、薬物供給部を格納するための少なくとも１つのウェルを含む。少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む。バルーンは、バルーンの内部と流体連通する複数の穿孔を含む。薬物供給部は、バルーンの外側表面上に提供されているコーティングである。
本開示のさらに別の側面によると、イオン導入薬物送達カテーテルが提供される。カテーテルは、カテーテルの遠位端に配置されるバルーンと、バルーンの表面上に配置され、エネルギー源に動作可能に連結される少なくとも１つの電極と、バルーンに動作可能に関連付けられた薬物供給部とを含む。薬物供給部は、薬物を選択的に放出するように構成される。薬物供給部は、少なくとも１つの薬物を含む。少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される。
バルーンの外側表面は、薬物供給部を格納するための少なくとも１つのウェルを含む。少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む。バルーンは、バルーンの内部と流体連通する複数の穿孔を含む。薬物供給部は、バルーンの外側表面上に提供されているコーティングである。
本開示のさらに別の側面によると、腎性高血圧の治療のための方法が提供される。本方法は、薬物送達カテーテルを腎動脈の管腔内に配置することと、カテーテルと腎動脈壁に隣接する神経との間に電位を発生させることと、電位を介して、薬物を神経に投与し、該神経の活性を減衰させることとを含む。
本開示の別の側面によると、高血圧患者が、腎臓除神経手技から恩恵を被り得るかどうかを決定する方法が提供される。本方法は、高血圧患者の血圧を測定することと、グアネチジンを高血圧患者に投与することと、高血圧患者の血圧が、グアネチジン投与後、変化したかどうかを決定することと、血圧変化を所定の値と比較することと、血圧変化が、所定の値を超える場合、高血圧患者に腎臓除神経手技を行うこととを含む。
本発明はさらに、例えば、以下を提供する。
（項目１）
イオン導入薬物送達システムであって、
エネルギー源と、
カテーテルと、
前記カテーテルの遠位端に配置されているバルーンと、
前記バルーンの表面上に配置され、前記エネルギー源に動作可能に連結されている少なくとも１つの電極と、
前記バルーンに動作可能に関連付けられている薬物供給部と
を備えている、イオン導入薬物送達システム。
（項目２）
前記薬物供給部は、薬物を選択的に放出するように構成されている、項目１に記載のイオン導入薬物送達システム。
（項目３）
前記薬物供給部は、少なくとも１つの薬物を含む、項目１に記載のイオン導入薬物送達システム。
（項目４）
前記少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される、項目３に記載のイオン導入薬物送達システム。
（項目５）
前記エネルギー源は、前記少なくとも１つの電極に直流電流を送達するように構成されている、項目１に記載のイオン導入薬物送達システム。
（項目６）
前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、項目１に記載のイオン導入薬物送達システム。
（項目７）
前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、項目６に記載のイオン導入薬物送達システム。
（項目８）
前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、項目１に記載のイオン導入薬物送達システム。
（項目９）
前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、項目１に記載のイオン導入薬物送達システム。
（項目１０）
イオン導入薬物送達システムであって、
エネルギー源と、
カテーテルと、
前記カテーテルの遠位端に配置されている拡張可能部材と、
前記拡張可能部材上に配置され、前記エネルギー源に動作可能に連結されている少なくとも１つの電極と、
前記拡張可能部材に動作可能に関連付けられている薬物供給部と
を備えている、イオン導入薬物送達システム。
（項目１１）
前記薬物供給部は、前記薬物を選択的に放出するように構成されている、項目１０に記載のイオン導入薬物送達システム。
（項目１２）
前記薬物供給部は、少なくとも１つの薬物を含む、項目１０に記載のイオン導入薬物送達システム。
（項目１３）
前記少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される、項目１２に記載のイオン導入薬物送達システム。
（項目１４）
前記エネルギー源は、前記少なくとも１つの電極に直流電流を送達するように構成されている、項目１０に記載のイオン導入薬物送達システム。
（項目１５）
前記拡張可能部材は、バルーンおよびフレームから成る群から選択される、項目１０に記載のイオン導入薬物送達システム。
（項目１６）
前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、項目１５に記載のイオン導入薬物送達システム。
（項目１７）
前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、項目１６に記載のイオン導入薬物送達システム。
（項目１８）
前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、項目１５に記載のイオン導入薬物送達システム。
（項目１９）
前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、項目１５に記載のイオン導入薬物送達システム。
（項目２０）
イオン導入薬物送達カテーテルであって、
前記カテーテルの遠位端に配置されているバルーンと、
前記バルーンの表面上に配置され、エネルギー源に動作可能に連結されている少なくとも１つの電極と、
前記バルーンに動作可能に関連付けられている薬物供給部と
を備えている、イオン導入薬物送達カテーテル。
（項目２１）
前記薬物供給部は、前記薬物を選択的に放出するように構成されている、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２２）
前記薬物供給部は、少なくとも１つの薬物を含む、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２３）
前記少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される、項目２２に記載のイオン導入薬物送達カテーテル。
（項目２４）
前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２５）
前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、項目２４に記載のイオン導入薬物送達カテーテル。
（項目２６）
前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２７）
前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２８）
腎性高血圧の治療のための方法であって、
薬物送達カテーテルを腎動脈の管腔内に配置することと、
前記カテーテルと前記腎動脈壁に隣接する神経との間に電位を発生させることと、
前記電位を介して、薬物を前記神経に投与し、前記神経の活性を減衰させることと
を含む、方法。
（項目２９）
高血圧患者が、腎臓除神経手技から恩恵を被り得るかどうかを決定する方法であって、
高血圧患者の血圧を測定することと、
グアネチジンを前記高血圧患者に投与することと、
グアネチジン投与後、前記高血圧患者の血圧が変化したかどうかを決定することと、
血圧変化を所定の値と比較することと、
前記血圧変化が前記所定の値を超える場合、前記高血圧患者に腎臓除神経手技を行うことと
を含む、方法。
（項目３０）
高血圧を治療するための方法であって、
薬物送達カテーテルを腎動脈の管腔内に配置することと、
前記カテーテルと前記腎動脈の壁に隣接する神経との間に電位を発生させることと、
前記電位を介して、薬物を前記神経に投与し、それによって、前記神経の活性を減衰させることと
を含む、方法。
本発明はさらに、例えば、以下を提供する。
（項目１）
イオン導入薬物送達システムであって、
エネルギー源と、
カテーテルと、
前記カテーテルの遠位端に配置されているバルーンと、
前記バルーンの表面上に配置され、前記エネルギー源に動作可能に連結されている少なくとも１つの電極と、
前記バルーンに動作可能に関連付けられている薬物供給部と
を備えている、イオン導入薬物送達システム。
（項目２）
前記薬物供給部は、薬物を選択的に放出するように構成されている、項目１に記載のイオン導入薬物送達システム。
（項目３）
前記薬物供給部は、少なくとも１つの薬物を含む、項目１に記載のイオン導入薬物送達システム。
（項目４）
前記少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される、項目３に記載のイオン導入薬物送達システム。
（項目５）
前記エネルギー源は、前記少なくとも１つの電極に直流電流を送達するように構成されている、項目１に記載のイオン導入薬物送達システム。
（項目６）
前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、項目１に記載のイオン導入薬物送達システム。
（項目７）
前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、項目６に記載のイオン導入薬物送達システム。
（項目８）
前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、項目１に記載のイオン導入薬物送達システム。
（項目９）
前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、項目１に記載のイオン導入薬物送達システム。
（項目１０）
イオン導入薬物送達システムであって、
エネルギー源と、
カテーテルと、
前記カテーテルの遠位端に配置されている拡張可能部材と、
前記拡張可能部材上に配置され、前記エネルギー源に動作可能に連結されている少なくとも１つの電極と、
前記拡張可能部材に動作可能に関連付けられている薬物供給部と
を備えている、イオン導入薬物送達システム。
（項目１１）
前記薬物供給部は、前記薬物を選択的に放出するように構成されている、項目１０に記載のイオン導入薬物送達システム。
（項目１２）
前記薬物供給部は、少なくとも１つの薬物を含む、項目１０に記載のイオン導入薬物送達システム。
（項目１３）
前記少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される、項目１２に記載のイオン導入薬物送達システム。
（項目１４）
前記エネルギー源は、前記少なくとも１つの電極に直流電流を送達するように構成されている、項目１０に記載のイオン導入薬物送達システム。
（項目１５）
前記拡張可能部材は、バルーンおよびフレームから成る群から選択される、項目１０に記載のイオン導入薬物送達システム。
（項目１６）
前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、項目１５に記載のイオン導入薬物送達システム。
（項目１７）
前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、項目１６に記載のイオン導入薬物送達システム。
（項目１８）
前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、項目１５に記載のイオン導入薬物送達システム。
（項目１９）
前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、項目１５に記載のイオン導入薬物送達システム。
（項目２０）
イオン導入薬物送達カテーテルであって、
前記カテーテルの遠位端に配置されているバルーンと、
前記バルーンの表面上に配置され、エネルギー源に動作可能に連結されている少なくとも１つの電極と、
前記バルーンに動作可能に関連付けられている薬物供給部と
を備えている、イオン導入薬物送達カテーテル。
（項目２１）
前記薬物供給部は、前記薬物を選択的に放出するように構成されている、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２２）
前記薬物供給部は、少なくとも１つの薬物を含む、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２３）
前記少なくとも１つの薬物は、グアネチジン、エピネフリン、ジメチル・スルホキシド（ＤＭＳＯ）、およびそれらの組み合わせから成る群から選択される、項目２２に記載のイオン導入薬物送達カテーテル。
（項目２４）
前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２５）
前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、項目２４に記載のイオン導入薬物送達カテーテル。
（項目２６）
前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２７）
前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、項目２０に記載のイオン導入薬物送達カテーテル。
（項目２８）
腎性高血圧の治療のための方法であって、
薬物送達カテーテルを腎動脈の管腔内に配置することと、
前記カテーテルと前記腎動脈壁に隣接する神経との間に電位を発生させることと、
前記電位を介して、薬物を前記神経に投与し、前記神経の活性を減衰させることと
を含む、方法。
（項目２９）
高血圧患者が、腎臓除神経手技から恩恵を被り得るかどうかを決定する方法であって、
高血圧患者の血圧を測定することと、
グアネチジンを前記高血圧患者に投与することと、
グアネチジン投与後、前記高血圧患者の血圧が変化したかどうかを決定することと、
血圧変化を所定の値と比較することと、
前記血圧変化が前記所定の値を超える場合、前記高血圧患者に腎臓除神経手技を行うことと
を含む、方法。
（項目３０）
高血圧を治療するための方法であって、
薬物送達カテーテルを腎動脈の管腔内に配置することと、
前記カテーテルと前記腎動脈の壁に隣接する神経との間に電位を発生させることと、
前記電位を介して、薬物を前記神経に投与し、それによって、前記神経の活性を減衰させることと
を含む、方法。
これらおよび他の利点は、図面を参照して、以下の本開示の種々の実施形態の発明を実施するための形態からより明白となるであろう。
本開示の特定の実施形態は、付随の注記および図面とともに、本明細書に後述される。しかしながら、開示される実施形態は、単に、種々の形態で具現化され得る、本開示の実施例であることを理解されたい。本明細書で使用される専門用語は、特定の実施形態を説明する目的のためだけのものであって、限定として意図されるものではない。公知および／または反復性の機能ならびに構造は、不必要または冗長な詳細において、本明細書を曖昧にするのを回避するために、詳細に説明されない。したがって、本明細書に開示される具体的構造および機能詳細は、限定として解釈されず、単に、請求項の基礎として、かつ事実上、任意の適切に詳細な構造において、本開示を多様に採用するための当業者への教示のための代表的基礎として、解釈される。
本明細書で使用される場合、用語「近位」は、従来通り、ユーザにより近い器具の端部を指す一方、用語「遠位」は、ユーザからより離れた端部を指すものとする。本明細書で使用される場合、配向を指す用語、例えば、「上部」、「底部」、「上方」、「下方」、「左」、「右」、「〜時の方向」、および同等物は、図ならびにその中に示される対応する軸および特徴を参照して、例証的目的のために使用される。本開示による実施形態は、制限なしに任意の配向において実践され得ることを理解されたい。本明細書で使用される場合、用語「イオン導入」は、電流が、薬物搬送イオンを刺激し、血管壁等の無傷組織を通過させるために使用される、薬物送達方法を指す。同様の参照番号は、同一、類似、または同等機能を行い得る、要素を表し得る。
本開示による実施形態では、イオン導入薬物送達システムおよび方法が提供される。各薬物送達システムは、身体管腔内に導入され、イオン導入を介して、薬物、薬剤、または他の治療用物質を標的組織に送達し得る、イオン導入カテーテルを含む。ある非限定的実施例では、開示されるカテーテルは、大腿動脈内に導入され、腎動脈内に前進させられ、腎神経束に隣接して位置付けられ得る。有利には、本開示によるイオン導入カテーテルは、腎神経束へのグアネチジンの標的送達による高血圧の治療のために、腎交感神経機能の減衰を可能にし得る。他の用途および他の薬物もまた、想定される。
図１、２、および３を参照すると、本開示による、薬物コーティングされたバルーンを取り付けられたイオン導入カテーテルを有する、腎神経の除神経のためのイオン導入薬物送達システムの例示的実施形態が示される。イオン導入薬物送達システムは、概して、参照番号１００によって指定される。システム１００は、下行大動脈および／または腎臓に隣接する腎動脈分岐のうちの１つ以上間の腎動脈の管腔内に配置されるように構成される、イオン導入カテーテル１１０を含む。
図１によって示される実施形態では、カテーテル１１０は、その遠位端１１４またはその近傍に、拡張可能部材またはバルーン１１２を含み、バルーン１１２は、膨張されると、腎神経１１９に近接した腎動脈１１７の壁のような血管壁１１６と円周全体に接触する。１つ以上の電極１１８は、バルーン１１２の表面に関連付けられる。本実施形態では、電極１１８は、バルーン１１２の外側表面１２０上に配置される。電極１１８は、少なくとも１つのワイヤ１２３を介して、エネルギー源１２２に動作可能に連結される。エネルギー源１２２は、２つのバルーン電極１１８間（例えば、双極モード）、および／または一方のバルーン電極１１８と、限定ではないが、皮膚、血管等の患者の身体の一部と接触して配置される別のバルーン電極１１８との間（例えば、単極モード）に、双極または単極電場を発生させるように構成される。
エネルギー源１２２は、エネルギー送達を調整かつ監視し、および／または関連パラメータ（組織インピーダンス、接触温度、組織温度等）を監視するように構成される、制御システムを含み得る。いくつかの実施形態では、エネルギー源１２２は、一定電流であるＤＣエネルギーを提供する。戻り電極１２４が、図１に示されるように、含まれ得る。
システム１００によって生成され、図１における破線によって図示される電場は、連続またはパルス直流であり得る。電極１１８は、バルーン１１２の外側表面１２０上に任意のパターンで位置付けられ、電場の特定の構成を提供し得る。電極１１８は、図２および３によって示されるような等しく離間されたパターンに位置付けられ、および／または電極１１８は、バルーン１１２の外側表面１２０上の無作為場所に位置付けられることができる。
電極１１８は、生成された電場の大部分が、腎神経１１９の最適な除神経のために腎神経１１９を貫通するように配列され得る。電極１１８はまた、生成された電場の末端が、腎神経１１９を貫通するように、図１に示されるように、配列されることができる。したがって、本開示によると、電極１１８は、腎神経１１９を貫通することが所望される電場の量に従って、バルーン１１２の外側表面１２０上に位置付けられることができる。
バルーン１１２またはカテーテル１１０の遠位端１１４はまた、カテーテルシャフト１２６を押し引きすることによって、腎動脈１１７等の血管の内部に沿って移動され得る。バルーン１１２は、電極１１８の作動に先立って、または電極１１８の作動の間、血管の内部に沿って、移動されることができる。バルーン１１２はまた、完全に膨張されている間、部分的に膨張されている間、または収縮されている間、血管の内部に沿って、移動され得る。
バルーン１１２および／またはカテーテルシャフト１２６等のカテーテルは、腎神経の除神経および／またはイオン導入薬物送達の間、腎臓の灌流を維持するために、バルーン１１２の一方の側から他方の側に血液を流動させるための１つ以上の管腔を含むことができる。図３に示される、管腔１２８等の１つ以上の管腔は、除神経手技または任意の他の所望の手技を完了させるために必要とされる間、バルーン１１２が膨張し続けることを可能にする。加えて、イオン導入薬物送達における薬物浸透の深度は、部分的に、印加される電流の持続時間に依存する。
使用の間、開示されるカテーテル１１０は、隣接する組織（例えば、血管壁、神経、および周囲組織）内に電位勾配を発生させ、ひいては、薬物のイオン導入送達を促進する。
開示されるイオン導入薬物送達システムはまた、標的組織に送達されるべき１つ以上の薬物の格納部を含む。好ましくは、少なくとも１つの薬物は、イオン形態である。例えば、限定ではないが、グアネチジンは、ノルエピネフリン（また、ノルアドレナリンとしても知られる）の放出を阻害することによって、交感神経の機能を減衰させることが知られている薬物である。グアネチジンは、＋２電荷を伴う、イオン形態に調合され得る。加えて、または代替として、他の薬物が利用され得る。例えば、限定ではないが、薬物は、薬物摂取の速度を改善するために（例えば、ジメチル・スルホキシド（ＤＭＳＯ）等の浸透または透過促進剤）、または局所的薬物効果を延長させるために（例えば、エピネフリン等の脈管血管収縮剤）、１つ以上の二次薬物と組み合わせられ得る。
いくつかの実施形態では、カテーテル１１０は、薬物の供給部を含み（例えば、薬物送達に先立って）、身体管腔および／または周囲組織内へのイオン導入送達のために、その放出を促進するように構成され得る。いくつかの実施形態では、他の実施形態に加えて、またはその代替として、薬物は、バルーン１１２の外側表面１２０を囲むコーティング１３０（図１）内に組み込まれ得る。
他の実施形態に加えて、またはその代替として、イオン導入薬物送達システム１００のバルーン１４０は、図４によって示されるように、穿孔されることができ（例えば、浸出バルーン）、例えば、カテーテルシャフト１２６を介した、薬物供給部からバルーン管腔１４２への薬物の投与が、複数の穿孔１４９を介して、バルーン１４０の内側体積から、電極１４６における、またはそれに隣接する外側表面１４４への薬物の輸送を生じさせる。薬物供給部は、患者の外部または外側にあり得る。
図４によって示される実施形態では、カテーテルシャフト１２６は、バルーン１４０の内側表面とほぼ同一の直径を有するようなサイズを有することができる。バルーン１４０の内側表面は、シャフト１２６の内側管腔１４１と流体連通する、少なくとも１つの開口部を含む。薬物は、圧力下、少なくとも１つの開口部（明示的に示されない）を介して、シャフト１２６を通して、バルーン１４０に送達される。薬物は、次いで、複数の穿孔１４９から、バルーン１４０の外側表面に押し出される。薬物はまた、カテーテルシャフト１２６以外の管腔を通して、バルーン１４０に送達されることができる。
いくつかの実施形態では、他の実施形態に加えて、またはその代替として、図５を参照すると、薬物は、バルーン１５０の表面上に配置される、１つ以上のウェル１４８内に格納され、それらの各々は、被覆層１５２によって被覆される。この被覆層１５２が破裂されると、ウェル１４８内側の薬物は、電極１５４の近傍に放出される。被覆層１５２は、機械的作用（例えば、バルーンが血管壁に対して押圧することによって印加される圧力）または熱の印加（例えば、金属被覆が、電極１５４からの電気エネルギーの印加を通して、抵抗加熱によって溶融される）によって、破裂され得る。
被覆層１５２は、例証的目的のために、図５では、下側の２つのウェルに対して、破裂されずに示される一方、上側の２つのウェルに対する被覆層１５２は、破裂されている。動作において、全被覆層１５２は、薬物送達システムの動作の間、同時またはほぼ同時に破裂される可能性が高い。
送達されるべき薬物が、電極１１８、１４６、１５４に隣接して位置しているときに、電場が２つ以上の電極間に印加される。薬物のイオン電荷が、薬物分子に、電場を辿らせ、それによって、例えば、単純拡散によって、生じるであろうより高速で組織に進入させる。組織内への薬物の高速摂取は、電気穿孔法によって向上させられ得、１つ以上の高電圧パルスが、組織内に一時的な孔を開くために印加され、ひいては、薬物摂取の加速を促進する。加えて、または代替として、イオン導入のために使用される直流は、組織インピーダンスが、印加される電流の周波数に伴って減少するので、パルス化され得る。電流の送達は、イオンの移動方向が、印加される電場の極性に依存するので、主に、直流である。いくつかの実施形態では、本開示によるイオン導入カテーテルは、有利には、望ましくない化合物、薬物、および毒素を標的組織から除去するために使用され得る。
前述の実施形態は、バルーンカテーテルを説明する。ほぼ円周全体の血管壁並置をもたらす追加または代替の方法もまた、本開示の範囲内で想定される。例えば、限定ではないが、いくつかの実施形態では、電極１１８、１４６、１５４は、雨傘のフレームに類似する拡張可能ワイヤフレーム上に搭載され得る。いくつかの実施形態では、電極１１８、１４６、１５４は、ステント状拡張可能部材またはフレーム上に搭載され得る。
また、開示されるのは、腎性高血圧の治療のための方法である。本方法は、図２に示されるカテーテル１１０等の薬物送達カテーテルを腎動脈１１７の管腔内に配置することを含む。本方法はさらに、カテーテルと腎動脈壁に隣接する神経との間に電位を発生させることを含む。本方法はさらに、電位を介して、前述の薬物等の薬物を神経に投与し、それによって、神経の活性を減衰させることを含む。
また、開示されるのは、高血圧患者が、腎臓除神経手技から恩恵を受ける可能性が高いかどうかを決定する方法である。これは、交感神経機能を抑制し得る、グアネチジンの確立された特性に基づく。本方法は、（１）患者の血圧を測定することと、（２）グアネチジンを患者に投与すること（例えば、経口錠剤、注射、または血管内送達）と、（３）グアネチジン投与後、患者の血圧変化を測定することと、（４）血圧変化を所定の値と比較することと、（５）血圧変化が、所定の値を超える場合、腎臓除神経手技を行うこととを含む。
本開示による薬物送達システムおよびカテーテルは、少なくとも以下の利点を有する。（１）熱の発生がなく、したがって、患者は、疼痛を被らない。（２）流動を制限する狭窄をもたらさない。（３）治療は、円周全体であって、したがって、１回のみの印加が、腎神経の治療を保証するために必要とされる。（４）システムおよびカテーテルは、治療の間、血管壁との並置を維持する。
本開示の説明される実施形態は、制限ではなく、例証であることが意図され、本開示のあらゆる実施形態を表すことを意図するものではない。本明細書に記載される本開示および／または事実上の以下の請求項かつ法律で認められた均等物の両方の精神あるいは範囲から逸脱することなく、前述の開示される実施形態のさらなる変形例ならびに他の特徴および機能、またはその代替が成されてもよく、あるいは多くの他の異なるシステムまたは用途に望ましいように組み合わせられ得る。
Claims (7)
- イオン導入薬物送達システムであって、
エネルギー源と、
カテーテルと、
前記カテーテルの遠位端に配置されているバルーンと、
前記バルーンの表面上に配置され、前記エネルギー源に動作可能に結合されている少なくとも１つの電極と、
前記バルーンに動作可能に関連付けられている薬物供給部であって、前記薬物供給部は、グアネチジンを含む、薬物供給部と
を備えている、イオン導入薬物送達システム。 - 前記薬物供給部は、薬物を選択的に放出するように構成されている、請求項１に記載のイオン導入薬物送達システム。
- 前記エネルギー源は、前記少なくとも１つの電極に直流電流を送達するように構成されている、請求項１〜請求項２のいずれか一項に記載のイオン導入薬物送達システム。
- 前記バルーンの外側表面は、前記薬物供給部を格納するための少なくとも１つのウェルを含む、請求項１〜請求項２のいずれか一項に記載のイオン導入薬物送達システム。
- 前記少なくとも１つのウェルは、破裂されるように構成されている被覆層を含む、請求項４に記載のイオン導入薬物送達システム。
- 前記バルーンは、前記バルーンの内部と流体連通する複数の穿孔を含む、請求項１〜請求項２のいずれか一項に記載のイオン導入薬物送達システム。
- 前記薬物供給部は、前記バルーンの外側表面上に提供されているコーティングである、請求項１〜請求項２のいずれか一項に記載のイオン導入薬物送達システム。
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- 2012-04-09 EP EP12735357.1A patent/EP2694150A1/en not_active Withdrawn
- 2012-04-09 JP JP2014504081A patent/JP5759615B2/ja not_active Expired - Fee Related
- 2012-04-09 KR KR1020137026368A patent/KR20130131471A/ko not_active Application Discontinuation
- 2012-04-09 US US13/442,788 patent/US20120259269A1/en not_active Abandoned
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2015
- 2015-05-06 US US14/705,318 patent/US9919144B2/en not_active Expired - Fee Related
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Also Published As
| Publication number | Publication date |
|---|---|
| CN103517731B (zh) | 2016-08-31 |
| WO2012161875A1 (en) | 2012-11-29 |
| CN103517731A (zh) | 2014-01-15 |
| US20120259269A1 (en) | 2012-10-11 |
| EP2694150A1 (en) | 2014-02-12 |
| US9919144B2 (en) | 2018-03-20 |
| US20150231386A1 (en) | 2015-08-20 |
| CA2832311A1 (en) | 2012-11-29 |
| US20180229022A1 (en) | 2018-08-16 |
| JP2014517731A (ja) | 2014-07-24 |
| KR20130131471A (ko) | 2013-12-03 |
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