JP2013509266A - 経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 - Google Patents
経皮的超音波腎神経除去による高血圧症を治療するための方法及び装置 Download PDFInfo
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Abstract
Description
本願は、米国仮特許出願第61/256429号(2009年10月30日出願)及び第61/292618号(2010年1月6日出願)の出願日の恩恵を主張するものであり、その開示の全体が、参照により本明細書に組み込まれる。
V=πr2 2h−πr1 2h
ここで、r1は振動子30の半径であり、r2は衝撃領域11の半径であり、hは振動子30の長さである。
Claims (35)
- 哺乳類対象において腎神経伝達を不活性化するための装置であって、
前記哺乳類対象の腎動脈へ挿入されて非集束超音波エネルギーを伝達する超音波振動子と、
前記超音波振動子に電気的に接続され、前記腎動脈を包含する少なくとも約0.5cm3の衝撃容積内に、前記衝撃容積全体の腎神経伝達を不活性化するのに十分な治療レベルで印加される非集束超音波エネルギーを伝達するように、前記超音波振動子を制御するアクチュエータと、
を含む装置。 - 前記アクチュエータは、前記衝撃容積内における約100〜約900ジュールの吸収用量を与えるために、約10〜約30ワットの音響出力レベルで前記非集束超音波エネルギーを約10〜約30秒間伝達するように、前記超音波振動子を制御する、請求項1に記載の装置。
- 前記アクチュエータは、前記腎動脈壁の温度を65℃未満に維持しながら、前記衝撃容積全体の温度が42℃超に達するように、前記超音波振動子を制御する、請求項1に記載の装置。
- 前記アクチュエータは、パルス関数を利用して前記非集束超音波エネルギーを伝達するように、前記超音波振動子を制御する、請求項1に記載の装置。
- 前記超音波振動子は、前記腎動脈の軸に沿った少なくとも約2mmの長さを含む形態で、前記超音波エネルギーを伝達する、請求項1に記載の装置。
- 前記超音波振動子は、前記腎動脈の軸に沿った少なくとも約2mmの長さを有する衝撃容積全体に、前記治療レベルで前記超音波エネルギーを印加する、請求項1に記載の装置。
- 遠位端部及び近位端部を有するカテーテルを更に含み、前記超音波振動子は、前記遠位端部に隣接して前記カテーテルに取り付けられ、前記カテーテル及び前記超音波振動子は、前記超音波振動子が前記腎動脈内に配置された際に、前記腎動脈内を十分な量の血液が流れるよう構成及び配置される、請求項1に記載の装置。
- 前記カテーテルは、前記超音波振動子を前記腎動脈壁に接触せずに保持するように構成及び配置される、請求項7に記載の装置。
- 前記超音波振動子は軸を有し、前記カテーテルは、前記腎動脈の軸と略平行に前記超音波振動子の軸を保持するように構成及び配置され、前記超音波振動子は、前記超音波振動子の軸の周囲360度の円筒形態で前記超音波エネルギーを伝達する、請求項7に記載の装置。
- 前記カテーテルは、前記超音波振動子に近接する中心配置要素を含み、前記中心配置要素は、前記腎動脈の略中心に前記超音波振動子を保持するように構成される、請求項1に記載の装置。
- 前記中心配置要素は、前記腎動脈を流れる血液を実質的に遮断することなく前記腎動脈壁に係合する膨張要素を含む、請求項10に記載の装置。
- 前記超音波振動子はさらに、超音波エネルギーを受信して、前記受信した超音波エネルギーを表す信号を生成し、
前記アクチュエータはさらに、
前記治療レベル未満のレベルで測定用超音波エネルギーを伝達するように前記超音波振動子を制御し、反射された測定用超音波エネルギーを表すエコー信号を前記超音波振動子から受信し、
前記受信したエコー信号を解析し、
前記受信したエコー信号に基づいて前記腎動脈のサイズを決定する、請求項1に記載の装置。 - 前記超音波システムは、前記腎動脈の決定サイズに応じ、治療効果のある前記非集束超音波エネルギーを伝達するのに用いられる音響出力を変えるよう、前記超音波振動子を制御する、請求項12に記載の装置。
- 哺乳類対象における腎神経伝達を不活性化するための方法であって、
前記哺乳類対象の腎動脈内に超音波振動子を挿入するステップと、
治療効果のある非集束超音波エネルギーが衝撃容積内の全ての前記腎神経伝達を不活性化するように、前記超音波振動子を作動させて前記腎動脈を包含する少なくとも約0.5cm3の前記衝撃容積内に前記治療効果のある非集束超音波エネルギーを伝達するステップと、
を含む方法。 - 前記超音波エネルギーは、前記衝撃容積全体に約100〜約900ジュールの吸収用量を提供するために、約10〜約30ワットの音響出力レベルで、約10〜約30秒間伝達される、請求項14に記載の方法。
- 超音波エネルギーを伝達する前記ステップは、前記衝撃域内の前記腎神経を42℃超に加熱しながら、前記腎動脈壁の温度を65℃未満に維持するようにして実行される、請求項14に記載の方法。
- 超音波振動子を挿入する前記ステップ及び超音波振動子を作動させて超音波エネルギーを伝達する前記ステップは、前記腎神経の実際の位置を測定せずに実行される、請求項14に記載の方法。
- 超音波振動子を作動させる前記ステップは、各腎動脈における前記超音波エネルギーの単一の印加が、当該腎動脈周囲の全ての前記腎神経伝達の不活性化に効果があるように実行される、請求項14に記載の方法。
- 超音波振動子を作動させる前記ステップの後に、前記腎動脈内に前記超音波振動子を再配置するステップと、
その次に、超音波振動子を作動させる前記ステップを繰り返すステップと、
をさらに含む、請求項14に記載の方法。 - 超音波振動子を作動させる前記ステップは、前記超音波エネルギーがパルス関数を用いて伝達されて実行される、請求項14に記載の方法。
- 超音波振動子を挿入する前記ステップは、前記超音波振動子が前記腎動脈内に配置された際に、前記腎動脈内を十分な量の血液が流れるようにして実行される、請求項14に記載の方法。
- 腎動脈内に超音波振動子を挿入する前記ステップは、前記超音波振動子が前記腎動脈壁に接触しないようにして実行される、請求項14に記載の方法。
- 前記治療効果のある非集束超音波エネルギーは、前記超音波振動子の周囲360度の円筒型において伝達される、請求項14に記載の方法。
- 前記治療効果のある非集束超音波エネルギーは、前記腎動脈の軸に沿った少なくとも約2mmの長さを有する形態で伝達される、請求項14に記載の方法。
- 前記治療効果のある非集束超音波エネルギーは、前記腎神経の少なくとも約2mmの長さにわたって伝達を不活性化する、請求項14に記載の方法。
- 治療効果のある非集束超音波エネルギーを伝達する前記ステップの前に、前記腎動脈内の略中心に前記超音波振動子を配置するステップをさらに含む、請求項14に記載の方法。
- 超音波振動子を略中心に配置する前記ステップは、前記腎動脈を流れる血液を実質的に減少しないようにして実行される、請求項25に記載の方法。
- 前記治療効果のある超音波エネルギーの出力レベル未満の出力レベルで非治療用の超音波エネルギーを用いるステップと、
反射した前記非治療用の超音波エネルギーを受信し、反射したエネルギーを表すエコー信号を生成するステップと、
超音波振動子を作動させて治療効果のある非集束超音波エネルギーを印加する前記ステップの前に、前記エコー信号に基づいて前記腎動脈のサイズを決定するステップと、
をさらに含む、請求項14に記載の方法。 - 決定する前記ステップにおいて決定された前記腎動脈のサイズに少なくとも一部において基づいて、前記治療効果のある非集束超音波エネルギーを放射する作動中に、前記超音波振動子に適用される出力を調節するステップをさらに含む、請求項28に記載の方法。
- 腎神経を不活性化するのに用いられるプローブであって、
非集束超音波エネルギーを伝達するための超音波振動子と、
遠位端部及び近位端部を有するカテーテルと、
を含み、前記超音波振動子は、前記遠位端部に隣接して前記カテーテルに取り付けられており、前記カテーテル及び前記超音波振動子は、前記遠位端部及び前記超音波振動子を前記腎動脈内に配置可能であり、前記超音波振動子が前記腎動脈内に配置された際に、前記腎動脈内を十分な量の血液が流れるように構成及び配置される、プローブ。 - 前記カテーテルは、前記超音波振動子を前記腎動脈壁に接触せずに保持するように構成及び配置される、請求項30に記載のプローブ。
- 前記超音波振動子は軸を有し、前記カテーテルは、前記腎動脈の軸と略平行に前記超音波振動子の軸を保持するように構成及び配置され、前記超音波振動子は、前記超音波振動子の軸の周囲360度の円筒形態で前記超音波エネルギーを伝達する、請求項30に記載のプローブ。
- 前記カテーテルは、前記超音波振動子に近接する中心配置要素を含み、前記中心配置要素は、前記腎動脈の略中心に前記超音波振動子を保持するように構成される、請求項30に記載のプローブ。
- 前記中心配置要素は、前記腎動脈を流れる血液を実質的に遮断することなく前記腎動脈壁に係合する膨張要素を含む、請求項33に記載のプローブ。
- 哺乳類対象において腎神経伝達を不活性化するための装置であって、
前記哺乳類対象の腎動脈に超音波振動子を配置する手段と、
治療効果のある非集束超音波エネルギーが衝撃容積内の全ての前記腎神経伝達を不活性化するように、前記超音波振動子を作動させて、前記腎動脈を包含する少なくとも約0.5cm3の前記衝撃容積内に前記治療効果のある非集束超音波エネルギーを伝達する手段と、
を含む装置。
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