JP2015503365A - 身体通路の組織又は身体通路に隣接する組織をリモデリングするための方法及び装置 - Google Patents
身体通路の組織又は身体通路に隣接する組織をリモデリングするための方法及び装置 Download PDFInfo
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Abstract
Description
1つの特定の円筒形の治療ゾーンは、2つの異なる電極アセンブリの2つの遠位の電極パッド、及び残りの電極アセンブリの1つの中間のテール部を含んでいてもよい。
各電極パッドは熱感知デバイスを含んでいてもよい。
各電極アセンブリは、近位の電極パッドから延びる近位のテール部を更に含んでいてもよい。
中間の接地ラインは、近位の接地ラインと共有される軸上に延びていてもよい。
遠位の電極パッドの遠位の接地電極及び近位の電極パッドの近位の接地電極はともに、中間の接地ライン及び近位の接地ラインと共有される軸に沿って延びていてもよく、それによって、遠位の接地電極、中間の接地ライン、近位の接地電極及び近位の接地ラインは全てその軸に沿って延びる。
可撓性回路のうちの少なくとも幾つかのエネルギー治療部位は、互いに対して長手方向及び周方向にオフセットされていてもよい。
エネルギー治療部位は、隣接する双極電極の対の間に位置決めされる温度センサをそれぞれ更に含んでいてもよい。
各可撓性回路は、第1の単極電極及び第2の単極電極を含んでいてもよい。第1の単極電極及び第2の単極電極は、周方向にオフセットされていてもよい。第1の可撓性回路の単極電極は、隣接する可撓性回路の単極電極に対して長手方向にオフセットされていてもよい。
可撓性回路の少なくとも幾つかのコーナーは丸みを帯びたコーナーとすることができる。
各可撓性回路は、可撓性回路に沿って長手方向に延びる少なくとも2つの別個の導体トレースを含んでいてもよい。
可撓性回路は、回路の可撓性を高めるように構成される開口を含んでいてもよい。
別の例示的なデバイスは、外面を含む拡張可能なバルーンを含む。少なくとも1つの可撓性回路を拡張可能なバルーンの外面に取り付けることができる。少なくとも1つの可撓性回路は第1の絶縁層を含んでいてもよい。少なくとも1つの熱感知デバイスを、第1の絶縁層内に少なくとも部分的に位置決めすることができる。導電層を第1の絶縁層の上に配置することができ、導電層の少なくとも一部を熱感知デバイスに電気的に接続することができる。第2の絶縁層を導電層の上に配置することができる。少なくとも1つの単極電極を導電層に関連付けることができる。
熱感知デバイスは、およそ0.15mm未満の厚さを有していてもよい。
熱感知デバイスは、組織と接触すると、単極電極及び組織の双方を表す温度を測定するべく構成されるように単極電極に対して位置決めすることができる。
デバイスは、10気圧(1013kPa)以下の膨張圧力、又は6気圧(608KPa)以下の膨張圧力で十分に膨張するように構成することができる。
少なくとも1つの電極は単極電極とすることができる。
熱感知デバイスの厚さは0.15mm未満とすることができる。
バルーンは、6気圧(608KPa)以下の膨張圧力で十分に膨張するように構成することができる。
第1のトレースは、長手方向に延びる第1の細長い電極トレースを含んでいてもよい。
第3のトレースは、熱感知構成部材に結合されている電源パッドを含んでいてもよい。
第1の複数の電極のそれぞれは長手方向に細長くなっていてもよい。
第2の細長い電極トレースは、第1の細長い電極トレースに実質的に平行であるものとすることができる。
上部絶縁層は、形状が下部絶縁層に実質的に合致していてもよい。
熱感知構成部材はサーミスタを含んでいてもよい。サーミスタはおよそ0.10mmの厚さとすることができる。
第1の複数の電極及び第2の複数の電極は金を含んでいてもよい。
熱感知デバイスは、およそ0.15mm未満の厚さを有していてもよい。例えば、熱感知デバイスは、およそ0.1mmの厚さを有していてもよい。
熱感知デバイスは、双極電極の対の間に位置決めすることができる。
熱感知デバイスは、組織と接触すると、双極電極及び組織の双方を表す温度を測定するべく構成されるように双極電極の対に対して位置決めすることができる。
双極電極の対は複数の活性電極及び複数の接地電極を含んでいてもよい。
複数の活性電極は第1の長手方向軸に沿って配置することができ、複数の接地電極は、第1の長手方向軸からオフセットされているとともに第1の長手方向軸に概ね平行である第2の長手方向軸に沿って配置される。
この方法はまた、熱感知デバイスを用いて、少なくとも1つの電極及び腎動脈の壁の双方を表す温度を測定することを含んでいてもよい。
バルーンはカニューレ付きでなくてもよい。
バルーンの外面の少なくとも一部を可撓性のポリイミド膜とすることができる。可撓性のポリイミド膜は、複数の可撓性回路の底部絶縁層を画定することができる。
各可撓性回路は、バルーンの外面に隣接する底部絶縁層を含んでいてもよい。
第1のバルーン及び第2のバルーンは、様々な外径のサイズである大きいプロファイル形態を有していてもよい。
大動脈と腎臓との間に延びる主たる腎動脈、及び大動脈と腎臓との間に延びる補助的な腎動脈を有し得る患者の腎除神経のための例示的なシステムは、第1のバルーンカテーテル及び第2のバルーンカテーテルを含み、それぞれが、小さいプロファイル形態及び大きいプロファイル形態を有するバルーンを有し、複数の可撓性回路が各バルーンの外面に沿って延び、各可撓性回路は少なくとも1つの電極を含む。バルーンのうちの少なくとも一方は、外径が4mm未満である大きいプロファイル形態を有していてもよい。このシステムはまた、第1のバルーンカテーテル及び第2のバルーンカテーテルの可撓性回路に電気的に接続されるように構成されているとともに、第1のバルーンカテーテル及び第2のバルーンカテーテルの電極を腎除神経エネルギーによって異なる時点で励起するように構成されている電源を含んでいてもよい。
第1のバルーン及び第2のバルーンは、様々な外径のサイズである大きいプロファイル形態を有していてもよい。
第3のバルーンの外径は、大きいプロファイル形態であるときは、4mm以上とすることができる。
バルーンはカニューレ付きでなくてもよい。
バルーンの外面の少なくとも一部は可撓性のポリイミド膜とすることができる。
バルーンの底部絶縁層の上面が、可撓性回路のうちの少なくとも1つの導電層に直接接触していてもよい。
大動脈と腎臓との間に延びる主たる腎動脈、及び大動脈と腎臓との間に延びる補助的な腎動脈を有する患者の腎除神経のための例示的なシステムも開示される。このシステムは、第1のバルーンカテーテル及び第2のバルーンカテーテルを含み、それぞれが、小さいプロファイル形態及び大きいプロファイル形態を有するバルーンを有し、複数の可撓性回路が各バルーンの外面に沿って延び、各可撓性回路は少なくとも1つの電極を含み、バルーンのうちの少なくとも1つは、外径が4mm未満である大きいプロファイル形態を有する。電源を、第1のバルーンカテーテル及び第2のバルーンカテーテルの電極に電気的に接続することができ、腎除神経エネルギーによって電極を励起するように構成することができる。
第1のバルーン及び第2のバルーンは、様々な外径のサイズである大きいプロファイル形態を有していてもよい。
第3のバルーンの外径は、大きいプロファイル形態であるときは、4mm以上のものとすることができる。
別の例示的な腎除神経方法は、細長い可撓性のカテーテル本体の径方向に拡張可能な構造を、大動脈を腎臓に接続する腎動脈内に位置決めすることを含んでいてもよい。径方向に拡張可能な構造は複数の電極を含んでいてもよい。この方法はまた、電極のサブセットが腎動脈の壁に係合するように径方向に拡張可能な構造を拡張させることであって、電極の別のサブセットは大動脈内にある、拡張させることと、電極に電気的に接続されている電源を用いて、腎動脈の壁に係合する電極のサブセットのうちの少なくとも幾つかを励起することと、を含んでいてもよい。
大動脈と腎臓との間に延びる主たる腎動脈と大動脈と腎臓との間に延びる補助的な腎動脈と、を有する患者の腎除神経のための別の例示的なシステムも開示される。このシステムは、第1のバルーンカテーテル及び第2のバルーンカテーテルを含み、それぞれが、小さいプロファイル形態及び大きいプロファイル形態を有するバルーンを有し、複数の可撓性回路が各バルーンの外面に沿って延び、各可撓性回路は少なくとも1つの電極を含む。バルーンのうちの少なくとも1つは、外径が4mm未満である大きいプロファイル形態を有していてもよい。このシステムはまた、第1のバルーンカテーテル及び第2のバルーンカテーテルの可撓性回路に電気的に接続されるように構成されているとともに、第1のバルーンカテーテル及び第2のバルーンカテーテルの電極を腎除神経エネルギーによって異なる時点で励起するように構成されている電源を含んでいてもよい。
第1のバルーン及び第2のバルーンは、様々な外径のサイズである大きいプロファイル形態を有していてもよい。
第3のバルーンの外径は、大きいプロファイル形態であるときは、4mm以上とすることができる。
治療サイクルは、第1の電極に漏電を誘発するように近接する少なくとも1つの電極を特定することを更に含んでいてもよい。第1の電極に漏電を誘発するように近接する少なくとも1つの電極は、治療サイクル中に励起されないものとすることができる。
電極のサブセットのうちの電極の所望の電圧を求めることは、電極のサブセットのうちのその電極に近接して測定された温度と目的温度との差に基づくものとすることもできる。
複数の可能な出力レベルを求めることは、複数の可能な出力電圧を求めることを含んでいてもよい。
第1のエネルギー送達部位の特定は、治療サイクル毎に、複数のエネルギー送達部位をサイクルすることができる。
電気外科的システムを用いて組織において所望の治療的変化を誘発する例示的な方法も開示される。この方法は、システムの複数の電極を複数の組織のゾーンに電気的に接続することと、組織を複数の加熱サイクルで加熱することと、を含んでいてもよい。各加熱サイクルは、関連付けられる選択されるゾーンを有することができ、所望の特性に応じて選択されるゾーンに関して所望の電位を求めることと、所望の電位の印加に適切な電極のセットを判断することと、電極の選択したセットを所望の電位で励起することと、を含んでいてもよい。この方法はまた、それらのゾーンからの温度信号をモニタリングすることと、ゾーンのうちの選択されるゾーンを交換することと、温度信号に応じて電極の所望の変更及びセットを特定することと、によって、ゾーンの組織において所望の治療的変化を同時に誘発することと、を含んでいてもよい。
複数の屈曲回路は、単極電極のうちの少なくとも1つに近接して温度感知構造を更に含むことができ、温度感知構造は、フィードバックを提供するようにプロセッサに電気的に接続されている。
拡張可能な構造の拡張した直径は約2mm〜約10mmとすることができる。例えば、拡張可能な構造の拡張した直径は約3mm以下とすることができる。
電気回路の特性を測定することは、電気回路に関連付けられる抵抗を測定することを含んでいてもよい。
複数の電極を含む拡張可能な構造を位置決めすることは、複数の単極電極を含む拡張可能な構造を位置決めすることを含んでいてもよい。
測定した特性が基準を満たすか否かを判断することは、第1の単極電極に関連付けられる測定した特性が第1の基準を満たすか否かを判断することと、第2の単極電極に関連付けられる測定した特性が第2の基準を満たすか否かを判断することと、を含んでいてもよい。第1の基準及び第2の基準は異なるものとすることができる。
拡張可能な構造は、少なくとも1つの共通電極を更に含んでいてもよい。
細長いカテーテルは、少なくとも1つの共通電極を更に含んでいてもよい。
エネルギーベースの治療を血管に近接する組織に送達する例示的な方法も開示される。この方法は、細長いカテーテルを用いて、エネルギーベースの治療システムの拡張可能な構造を、血管内の位置に位置決めすることであって、拡張可能な構造はカテーテルの遠位端部に又は遠位端部付近に位置決めされ、複数の単極電極を含む、位置決めすることを含んでいてもよい。エネルギーベースの治療システムは、共通電極及び電源を更に含むことができ、電源は複数の単極電極に電気的に接続されている。この方法はまた、複数の電極のうちの少なくとも幾つかが組織に接触するように拡張可能な構造を拡張させることと、プロセッサを用いて、複数の電気回路の特性を測定することであって、各電気回路は複数の単極電極及び共通電極のうちの1つに関連付けられる、測定することと、プロセッサを用いて、励起のための単極電極のサブセットを特定することであって、特定した電極のサブセットは、所望の範囲内にある測定した特性を有する、特定することと、励起のために特定した単極電極のうちの1つ又は複数を同時に励起することと、を含んでいてもよい。
エネルギーベースの治療を血管に近接する組織に送達する別の例示的な方法は、細長いカテーテルの拡張可能な構造を、血管内の位置に位置決めすることであって、拡張可能な構造はカテーテルの遠位端部に又は遠位端部付近に位置決めされ、複数の単極電極を含み、複数の単極電極のうちの少なくとも幾つかは拡張可能な構造に沿って長手方向に離間し、複数の電極は電源に電気的に接続されている、位置決めすることと、複数の電極のうちの少なくとも幾つかが組織に接触するように拡張可能な構造を拡張させることと、複数の電極のサブセットを選択的に励起することと、プロセッサを用いてエネルギーの送達を制御することであって、治療ゾーンに送達されるエネルギーが内部の組織を所望の範囲内の温度に加熱するように、電極のうちの少なくとも幾つかに関連付けられる電気回路からのフィードバックのモニタリングに基づいてエネルギー治療の1つ又は複数のパラメータを調節する、制御することと、を含んでいてもよい。
電極のサブセットを特定することは、複数の電極のそれぞれに関連付けられる電気回路の特性を測定することを含んでいてもよい。
励起のためのサブセットを特定することは、実質的に同様の測定した特性を有する電極の群を特定することを含んでいてもよい。
複数の電極のそれぞれに関連付けられる測定した特性が所定の要件を満たすか否かを判断することは、複数の電極のそれぞれに関連付けられる測定した特性が所定の範囲内に入るか否かを判断することを含んでいてもよい。
治療サイクルは、第1の単極電極に関連付けられる電気回路の特性とは実質的に異なる電気回路の特性に関連付けられる少なくとも1つの単極電極を特定することを更に含んでいてもよい。実質的に異なる電気回路の特性に関連付けられる少なくとも1つの単極電極は、治療サイクル中は励起されないものとすることができる。
複数の別個の単極エネルギー送達部位を有するエネルギー送達デバイス、共通電極、エネルギー発生器、及び、単極エネルギー送達部位をエネルギー発生器に結合するとともに複数の単極エネルギー送達部位を選択的に励起するように構成されているコントローラ、を備える装置を用いて身体通路を治療する例示的な方法も開示される。この方法は、装置を用いて身体通路を複数の治療サイクルに供することを含んでいてもよい。治療サイクルのうちの少なくとも幾つかは、治療の所定のパラメータを維持するように単極エネルギー送達部位の少なくともサブセットに関して複数の可能な出力レベルを求めることと、単極エネルギー送達部位のうちの1つに関して求めた可能な出力レベルに対応するようにエネルギー発生器の実際の出力レベルを設定することと、単極エネルギー送達部位のうちの少なくとも幾つかを実際の出力レベルにおいて励起し、エネルギーを身体通路に送達することと、を含んでいてもよい。実際の出力レベルを設定するのに用いられる単極エネルギー送達部位は、少なくとも幾つかの場合、治療サイクル毎に変更することができる。
鬱血性心不全を治療する例示的な方法は、患者の鬱血性心不全を治療するために、治療が患者内のノルエピネフリン濃度を50%超低下させるのに効果的であるように、患者の腎組織を高周波エネルギーに10分未満にわたって付すことを含んでいてもよい。
腎組織を高周波エネルギーに10分未満にわたって付すことは、腎組織を高周波エネルギーに5分未満にわたって付すことを含んでいてもよい。
腎組織を高周波エネルギーに付すことは、腎組織に近接する温度を、およそ50℃〜80℃の範囲の温度に上昇させることを含んでいてもよい。
温度が目的温度に近づくにつれて温度変化の速度が徐々に低下するように温度を上昇させることは、温度が目的温度に近づくにつれて温度変化の速度が直線的に低下するように温度を上昇させることを更に含んでいてもよい。
鬱血性心不全は拡張期鬱血性心不全であり得る。
例示的な腎除神経治療方法は、腎除神経カテーテルシステムのカテーテルアセンブリを用いて、腎動脈に近接する組織にRFエネルギー治療を送達することを含んでいてもよい。除神経システムは、コントローラによってカテーテルアセンブリに結合されているRFエネルギー発生器を含んでいてもよい。この方法はまた、カテーテルアセンブリを用いて、腎動脈に近接する組織に神経活性刺激を加えることと、カテーテルアセンブリを用いて、組織の刺激された神経活性反応を評価することと、評価した神経活性に基づいてRFエネルギー治療のパラメータを求めることと、を含んでいてもよい。
データを出力することは、神経活性の十分な低下が生じたか否かを出力することを含んでいてもよい。
第1の神経活性測定値を採用することは、RFエネルギー治療の送達を開始する前に第1の神経活性測定値を採用し、基準神経活性測定値を確立することを含んでいてもよい。第2の神経活性測定値を採用することは、RFエネルギー治療の送達を開始した後で第2の神経活性測定値を採用することを含んでいてもよい。この方法はまた、神経活性が基準値から変化したか否かを判断することを含んでいてもよい。
この方法はまた、神経活性の変化が閾値であるか又は閾値を上回ると、RFエネルギー治療を終了することを含んでいてもよい。
神経活性刺激を加えることは、カテーテルアセンブリの少なくとも1つの電極を励起することを含んでいてもよい。刺激された神経活性反応を評価することは、カテーテルアセンブリの第2の電極を用いて神経反応信号をモニタリングすることを含んでいてもよい。
RFエネルギー治療を送達することは、拡張可能なデバイスの近位端部に少なくとも1つの電極を、かつデバイスの遠位端部に第2の電極を有するカテーテルアセンブリを用いることを含んでいてもよい。
神経反応信号をモニタリングすることは、神経反応信号の振幅を測定することと、神経刺激信号と神経反応信号との間の時間遅延を測定することと、神経反応信号の分割振幅を測定することと、のうちの少なくとも1つを含んでいてもよい。
RFエネルギー治療の少なくとも1つのパラメータを求めることは、評価した神経活性に基づいて少なくとも1つのパラメータを調整することを含んでいてもよい。
少なくとも1つのパラメータを調整することは、目的温度プロファイルの目的温度における時間の長さを調整することを含んでいてもよい。
少なくとも1つのパラメータを調整することは、目的温度を一定に維持しながら電圧設定を調整することを含んでいてもよい。
この方法はまた、カテーテルアセンブリを位置決めし直すことと、腎動脈に近接する第2の組織部分に第2のRFエネルギー治療を送達することと、を含んでいてもよい。
別の例示的な腎除神経方法は、第1の神経活性刺激を、腎除神経システムのカテーテルアセンブリに近接する組織に加えることと、カテーテルアセンブリを用いて組織の第1の刺激された神経活性反応を測定することと、カテーテルアセンブリを用いて腎動脈に近接する組織にエネルギー治療を送達することと、カテーテルアセンブリを用いて神経組織の第2の神経活性反応を測定することと、第1の測定した神経活性及び第2の測定した神経活性を比較することによって、エネルギー治療のパラメータを求めることと、を含んでいてもよい。
治療は、腎動脈に近接する身体の組織内のノルエピネフリン濃度を50%超低下させるのに効果的であるものとすることができる。
治療は、患者の拡張期血圧を、少なくとも5%、又は少なくとも10%、又は少なくとも20%だけ低下させるのに効果的であるものとすることができる。
全ての数値は、本明細書では、明示的に示されるか否かにかかわらず、「約」という用語によって修飾されるものと想定される。「約」という用語は、概して、当業者が記載の値と同等である(すなわち同じ機能又は結果を有する)とみなすであろう数字の範囲を指す。多くの場合、「約」という用語は、最も近い有意な数字に四捨五入される数字を含んでいてもよい。
本明細書及び添付の特許請求の範囲において用いられる場合、単数形(“a”,“an”及び“the”)は、その内容による別段のはっきりした指示がない限り、複数の指示対象を含む。本明細書及び添付の特許請求の範囲において用いられる場合、「又は」という用語は、概して、その内容による別段のはっきりした指示がない限り、「及び/又は」を含む意味で用いられる。
システムの概説
図1Aは、身体通路内で治療を行うシステム100を示している。システム100は制御ユニット110を含む。制御ユニット110は、RFエネルギーをカテーテルデバイス120に送達するRF発生器を含んでいてもよい。本明細書において開示される実施形態とともに使用可能な例示的な制御ユニット及び関連するエネルギー送達方法が、参照により本明細書に援用される、本発明の譲受人に譲渡された米国特許出願公開第2012/0095461号明細書に開示されている。本明細書において開示される実施形態とともに使用可能な更なる例が、本発明の譲受人に譲渡された、「Tuned RF Energy for Selective Treatment of Atheroma and Other Target Tissues and/or Structures」と題する米国特許第7,742,795号明細書、「Selectable Eccentric Remodeling and/or Ablation of Atherosclerotic Material」と題する米国特許第7,291,146号明細書、及び「System for Inducing Desirable Temperature Effects on Body Tissue」と題する米国特許出願公開第2008/0188912号明細書に開示されており、これらの開示全体が参照により本明細書に援用される。幾つかの実施形態では、特に単極のエネルギー送達を用いる幾つかの実施形態では、システムはまた、カテーテルデバイスに関連付けることができる接地/共通電極、制御ユニット110に電気的に接続されるか又はシステム100に別様に関連付けられる別個のパッドを含んでいてもよい。
拡張可能なデバイス及び電極アセンブリ
図1Aを参照すると、カテーテルデバイス120は、柔軟であるか、柔軟ではないか、又は半柔軟性であるバルーンであり得る拡張可能なデバイス130を含んでいてもよい。拡張可能なデバイス130は、制御ユニット110に電気的に接続されている複数の電極アセンブリを含む。そのような電極アセンブリは、単極又は双極であるように電気的に構成することができ、熱感知機能を更に有する。
a.重なり合う治療ゾーン及び重なり合わない治療ゾーン
図1Bを参照すると、治療ゾーンA〜Dは、長手方向軸L−Lに沿って互いに長手方向に隣接しており、電極アセンブリによって印加されるエネルギーが重なり合わない治療を形成するように構成することができる。長手方向に隣接する双極電極アセンブリ140a〜dによって適用される治療は、長手方向軸L−Lに沿って周方向に不連続的である。例えば、図1Cを参照すると、治療ゾーンAにおいて形成されている損傷部位は、幾つかの実施形態では、治療ゾーンBにおいて形成される損傷部位と、外周の周りで(この図ではL−Lに対して横方向に)最小限にしか重なり合わないものとすることができる。
b.電極アセンブリの構造
図1Cを参照すると、各電極パッドアセンブリは、遠位の電極パッド150a〜d、中間のテール部160a〜d、近位の電極パッド170a〜d、及び近位のテール部180b、d(電極パッドアセンブリ140b及び140cについては示されていない)である4つの主要な要素を含む。電極アセンブリ140a〜dの構造の詳細は、図2A〜図2Cを参照して示し、説明する。
図2Bは、遠位の電極パッド208の部分断面A−Aを示している。電極222が絶縁層206の一部分に重ねられて示されており、絶縁層206は、電極222を(導電層204の)接地トレース210の細長い電極支持体216に結合することを可能にするように複数の通路(例えば孔)を有する。
図5Cは、電極アセンブリ500と同様に構成されるが、電極パッド512上に比較的大きな電極の表面積及びより多数の電極を有する電極アセンブリ510を示している。
図5Eは、電極アセンブリ500と同様に構成されるが、電極パッド516上に比較的小さな電極の表面積及びより少数の電極518を有する電極アセンブリ514を示している。電極パッド516は、電極と同じ側に取り付けられる2つの熱感知デバイス520も組み込む。
図2〜図5Fの電極アセンブリは、双極又は単極の構成において用いることができる。図5G〜図5Iは、単極電極の構成の付加的な例を示している。図5Gでは、温度センサ532の両側に単極電極530の2つの平行なアレイがある。図5Gでは、単極電極530の各アレイはそれ自身の別個のトレースを有し、温度センサ532もそれ自身の別個のトレースを有する。しかしながら、他の実施形態では、特定の屈曲回路アセンブリの単極電極530の全てが単一の活性トレースを共有することができ、温度センサの2つのトレースのうちの一方も共有されることができるが、他の実施形態では、温度センサの電源及び接地トレースは、単極のトレース(複数の場合もあり)とは別個であるものとすることができる。
治療方法及び制御システム
a.デバイスの位置決め
図6は、本開示の1つの非限定的な実施形態による、治療方法600を行うのに用いられる図1Aのシステム100を示している。ここで、制御ユニット110は、カテーテルデバイスに動作結合されて示されており、カテーテルデバイスは、(複数の電極アセンブリを有する)拡張可能なデバイスが、治療が必要とされる身体通路のセクションS1に隣接して配置されるように身体通路内に配置されている。セクションS1へのカテーテルデバイスの配置は、従来の方法に従って、例えば透視下でガイドワイヤによって行うことができる。
b.エネルギーの送達
必要とされる特定のリモデリング効果に応じて、制御ユニットは、1秒〜180秒にわたって約0.25ワット〜5ワットの平均出力、すなわち約0.25ジュール〜900ジュールで電極を励起することができる。より高いエネルギーの治療は、90秒にわたって0.5ワット又は180秒にわたって0.25ワットといったように、より低い出力かつより長い持続時間で行うことができる。単極の実施形態では、制御ユニットは、電極の構成、及び電極と共通接地との間の距離に応じて、最高5分間にわたって最高30ワットで電極を励起することができる。より短い距離であれば、エネルギーがより少ない伝導損失でより局所的なエリアにわたって進むため、より短い時間にわたってより低いエネルギーを提供することができる。腎除神経において用いられる例示的な実施形態では、治療ゾーンが治療中に約68℃まで加熱されるように、エネルギーが約5ワットの治療設定で約30秒にわたって送達される。上述したように、出力要件は、電極のタイプ及び構成に応じて大きく変わり得る。概して、より広い電極の間隔の場合、より高い出力が必要とされ、この場合、平均出力は5ワットよりも高くなることができ、総エネルギーは45ジュールを超えることができる。同様に、より短いか又はより小さい電極の対を用いると、平均出力を縮小することが必要とされ、総エネルギーは4ジュールよりも低くなることができる。出力及び持続時間は、幾つかの場合、深刻な損傷を引き起こすのに十分であるよりも低く、特に血管内の罹患組織を焼灼するのに十分であるよりも低いように校正することができる。血管内のアテローム性動脈硬化部位を焼灼する機構は、Slager他による「Vaporization of Atherosclerotic Plaque by Spark Erosion」と題する文献(J.of Amer.Cardiol.(June,1985),pp.1382−6)、及びStephen M. Fryによる「Thermal and Disruptive Angioplasty:a Physician’s Guide」、Strategic Business Development,Inc.,(1990)を含め、十分に記載されている(この開示全体は参照により本明細書に援用される)。
c.目的温度
RFエネルギーの印加は、目的組織も並んだ組織も不可逆的な熱損傷を持続しないように、目的組織及び/又は並んだ組織の温度を制限し、例えば目的組織の加熱を制限するよう、制御することができる。幾つかの実施形態では、表面温度の範囲は約50℃〜約90℃である。緩やかな加熱の場合、表面温度は約50℃〜約70℃の範囲であるものとすることができ、一方で、より積極的な加熱の場合、表面温度は、約70℃〜約90℃の範囲であるものとすることができる。バルク組織の温度がたいていは50℃〜55℃未満のままであるように、並んだ組織の加熱を約50℃〜約70℃の範囲の表面温度未満に抑えるよう加熱を制限することは、狭窄、熱損傷等につながりかねない免疫反応を抑制することができる。50℃〜70℃の間の比較的穏やかな表面温度は、より大きい血管腔及び改善された血流を提供するように、治療に対する組織の治癒反応を通じて、治療中、治療直後、及び/又は治療後1時間、1日、1週間、若しくは更には1か月よりも後にタンパク質結合を変性及び破壊するのに十分であるものとすることができる。
d.制御アルゴリズム
図13及び図14は、上述し、かつ図7〜図10に示されているような目的温度プロファイル、又は他のプロファイルに基づく、上述し、かつ図1〜図6に示されているような電気外科的デバイス、又は他のデバイスのエネルギーの印加を制御する方法の1つの実施形態を示している。この制御方法は、図1の制御ユニット110の処理機能、及び/若しくは上記で更に詳細に記載した制御ソフトウェアを用いて、又は他の方法で実行することできる。少なくとも幾つかの場合、制御方法は、比較的簡単でロバストなエネルギー発生器を用いて、単一の出力設定(例えば電圧)で電極のうちの幾つか又は他の送達部位を同時に励起しながら、デバイスの種々の治療部位における温度又は他の治療パラメータ(複数の場合もあり)の微調節を提供するが、このことによってシステムのコスト、サイズ及び複雑さを最小限に抑えることができる。制御方法は、目的温度又は他の治療パラメータ(複数の場合もあり)からのずれを最小限に抑えることができ、したがって、治療の任意の時間スライス中のエネルギー発生器に対する要求(例えば電圧要求)の変化を最小限に抑える。
ステップ1300に示されているように、各電極を最初はオフに設定する。ステップ1302において、電極のうちの1つを、その治療サイクルの主電極として指定する。以下で更に詳細に説明するように、治療中に指定された主電極は、治療サイクル毎に変わる(例えば、サイクルを通して全ての電極を利用可能である)。どの電極を主電極として指定するかの判断は、ルックアップテーブルにアクセスするか、又は主電極を特定するとともに治療サイクル毎に主電極の選択を変える任意の他の好適な機能を用いることによって行うことができる。
Vは目的電圧であり、
Teは目的からの温度誤差であり、
VLは最後に割り当てられた電極の電圧であり、
KL、KP及びKIは定数であり、
nは0秒〜t秒の範囲の時間値である。
Vは目的電圧であり、
Teは目的からの温度誤差であり、
VLは最後に割り当てられた電極の電圧であり、
KPは比例制御の定数であり、
KIは積分制御の定数である。
ステップ1314において、励起すべき電極がその時点で68℃よりも高い温度であるか否かを判断する。68℃よりも高い温度である電極はオフにするか、又はそうでなければ、その治療サイクルにおいて励起されないようにし、上記基準を別様に満たす電極をステップ1316において設定電圧において励起する。その後、別の治療サイクルを開始し、治療が完了するまで図13の制御ループを繰り返す。幾つかの実施形態では、各治療サイクルは前回の及び次のサイクルと重ならない(例えば、図13のステップは、次のサイクルのステップを開始する前に完全に行われる)が、他の実施形態では、これらのサイクルは少なくとも或る程度まで重なってもよい。
e.神経信号の刺激及びモニタリング
上述した実施形態のうちの少なくとも幾つかでは、又は代替的な実施形態では、腎除神経治療方法及びシステムは、神経信号の刺激、及び治療した腎動脈に近接する組織における神経信号反応のモニタリングを提供することができる。幾つかの場合、神経活性のこの電気記録図は、除神経治療の有効性の評価を提供し、及び/又は治療を調節するフィードバックを提供することができる。少なくとも幾つかの実施形態では、そのような電気記録図は、神経活性が存在するか否か、及び/又は測定された基準値に対してシフトしている(例えば低下している)か否かの評価を提供し、腎動脈に近接する神経組織の存在のマッピング又は定量を伴わない。
小さい/分岐した血管及び他の通路の治療
本明細書において記載されるシステム及びデバイスは、他のエネルギーベースの治療システム及びデバイスが好適ではない状況において有利に用いることができる。例えば、本明細書において記載されるシステム及びデバイスの実施形態は、他のカテーテルベースのエネルギー治療システムを用いて治療するには小さすぎる血管及び他の通路において用いることができる。幾つかの場合、本明細書において記載されるシステム及びデバイスは、4mm未満の直径及び/又は20mm未満の長さを有する腎動脈又は他の血管において用いることができる。血管の捩れ、及び治療を受けるべきではない領域に治療部位が近接していること等の他の要因は、以前のデバイスを用いた治療には禁忌であるか、或いは、そうでなければ適していない可能性があるが、本明細書において記載するシステム及びデバイスの少なくとも幾つかの実施形態ではそうではない。
Claims (15)
- 長手方向軸に沿って延びるカテーテルと、
カテーテルの端部に結合されるバルーンであって、拡張状態では、前記長手方向軸に沿って延びる複数の円筒形の治療ゾーンを有するバルーンと、
前記バルーンに取り付けられる複数の電極アセンブリであって、各電極アセンブリが、遠位の電極パッド及び近位の電極パッドを含み、遠位の電極パッドが中間のテール部によって近位の電極パッドから長手方向に離間しており、各電極アセンブリが双極電極の対を含んでおり、遠位の電極パッド及び近位の電極パッドが、前記バルーンの拡張状態では互いに対して周方向にオフセットいる、複数の電極アセンブリと、を含む、デバイスであって、
前記複数の電極パッドは、各円筒形の治療ゾーンが複数の電極アセンブリのうちの少なくとも1つの遠位の電極パッド及び近位の電極パッドのうちの少なくとも一方を含むように、それぞれ長手方向に配置されており、
各電極アセンブリの中間のテール部は、任意の特定の電極アセンブリの遠位の電極パッド及び近位の電極パッドがバルーンの隣接しない治療ゾーンを占めるように、長手方向に延びている、デバイス。 - 前記バルーンは4つの円筒形の治療ゾーンを有し、2つの電極アセンブリは、各ゾーンが1つの遠位の電極パッド又は1つの近位の電極パッドを含むようにバルーンに結合される、請求項1に記載のデバイス。
- 前記バルーンは4つの円筒形の治療ゾーンを有し、2つの隣接しない円筒形の治療ゾーンのそれぞれが2つの遠位の電極パッド又は2つの近位の電極パッドを含み、かつ他の2つの隣接しない円筒形の治療ゾーンのそれぞれが1つの遠位の電極パッド又は1つの近位の電極パッドを含むように、3つの電極アセンブリが前記バルーンに結合される、請求項1に記載のデバイス。
記載のシステム。 - 1つの特定の円筒形の治療ゾーンは、1つの電極アセンブリの1つの近位の電極パッドと、2つの他の電極アセンブリの2つの中間のテール部と、を含む、請求項3に記載のデバイス。
- 1つの特定の円筒形の治療ゾーンは、2つの異なる電極アセンブリの2つの遠位の電極パッドと、残りの電極アセンブリの1つの中間のテール部と、を含む、請求項3に記載のデバイス。
- 前記バルーンは4つの円筒形の治療ゾーンを有し、2つの隣接しない円筒形の治療ゾーンのそれぞれが2つの遠位の電極パッド又は2つの近位の電極パッドを含み、他の2つの隣接しない円筒形の治療ゾーンのそれぞれが1つの遠位の電極パッド又は1つの近位の電極パッドを含むように、4つの電極アセンブリが前記バルーンに結合される、請求項1に記載のデバイス。
- 2つの異なる電極アセンブリの2つの遠位の電極パッドは、特定の円筒形の治療ゾーンを占め、これらの2つの近位の電極パッドのそれぞれは、他の2つの他の電極アセンブリのうちの一方の中間のテール部によって周方向に離間される、請求項6に記載のデバイス。
- 2つの異なる電極アセンブリの2つの近位の電極パッドは、特定の円筒形の治療ゾーンを占め、これらの2つの近位の電極パッドのそれぞれは、他の2つの他の電極アセンブリのうちの一方の中間のテール部によって周方向に離間される、請求項6に記載のデバイス。
- 各電極パッドは接地電極及び活性電極を含む、請求項1乃至8のいずれか一項に記載のデバイス。
- 各電極パッドは熱感知デバイスを含む、請求項1乃至9のいずれか一項に記載のデバイス。
- 各電極アセンブリは、近位の電極パッドから延びる近位のテール部を更に含む、請求項1乃至10のいずれか一項に記載のデバイス。
- 各電極アセンブリについて、前記中間のテール部は、中間の接地ライン、中間の活性電極ライン及び中間の熱センサラインを含み、近位のテール部は、中間の活性電極ライン、中間の熱センサライン、近位の接地ライン、近位の活性電極ライン及び近位の熱感知ラインを含む、請求項1乃至11のいずれか一項に記載のデバイス。
- 前記中間の接地ラインは、近位の接地ラインと共有される軸上に延びている、請求項12に記載のデバイス。
- 遠位の電極パッドの遠位の接地電極及び近位の電極パッドの近位の接地電極はともに、中間の接地ライン及び近位の接地ラインと共有される軸に沿って延びており、それにより、遠位の接地電極、中間の接地ライン、近位の接地電極及び近位の接地ラインは全て前記軸に沿って延びる、請求項13に記載のデバイス。
- (a)細長いカテーテルと、
(b)前記カテーテルに関連付けられる拡張可能なバルーンと、
(c)前記拡張可能なバルーンの表面に沿って長手方向に延びる複数の周方向に離間した可撓性回路と、
を含む、デバイスであって、
各可撓性回路は少なくとも1つの電極を含み、前記電極は互いに対して軸方向及び周方向に離間しており、前記可撓性回路は、拡張可能なバルーンに接着固定されるとともに同可撓性回路を貫通する複数の開口を含み、前記開口は、前記可撓性回路の可撓性を高めるように構成される、デバイス。
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