JP2017196461A - 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。
式:V=πr2 2h−πr1 2h(r1は前記振動子の半径、r2は前記衝撃領域の半径、hは前記振動子の長さ)
近位端部と遠位端部との間を延伸し、線32は、振動子30から管腔34を通り抜けて、カテーテル18の近位端部14まで延伸する。
方の圧力センサが、カテーテル18の遠位に流れる液体を監視して閉塞があるか否かを判定し、他方が、カテーテル18における液漏を監視する。バルーンが膨張状態にある間は、圧力センサ38は、バルーン内を所望の圧力、好ましくは約3ポンド/平方インチ(20KPa)に維持する。
カテーテルにおけるバルーン24は、カテーテルの遠位端部が腎動脈内の所望の位置に配置されるまで収縮状態を維持することが好ましい。カテーテル18及び振動子30の挿入中(ステップ56)、医師は、腎臓6又は存在するであろう腎動脈10のあらゆる分岐の前であっても、腎動脈10内での振動子30の配置を確認できる。このような確認は、蛍光透視法などのX線技術を利用して実現され得る。
コー信号における時間遅延の幅をもたらすことがある。超音波システム20は、その幅の平均を取得して腎動脈10の平均サイズを決定し、その平均サイズに基づいて出力レベルを調節できる。
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。
の変更では、カテーテル18が身体内に導かれ、その後、腎臓6に近接して配置される経路は、前述の心房へ近づく経路とは異なる。静脈への進入は、カテーテル18を取り出した後の閉鎖の問題を低減し得るという利点により、利用されることができる。
Claims (13)
- 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、
遠位端部に沿って配置される拡張可能なバルーンを有するカテーテルと、
前記カテーテルの遠位端部の拡張可能なバルーン内に包含される超音波振動子であって、前記哺乳類対象の腎動脈へ挿入されて、前記超音波振動子の軸の周囲360度の円筒形態で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0.5cm3の衝撃容積内に、当該腎動脈の内膜層を損傷させることなく、前記衝撃容積全体の腎神経伝達を不活性化するために、治療用量の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、
を含み、
前記超音波振動子及び前記腎動脈の内面を冷却するために、拡張された前記バルーンへ循環する冷却された液体の流れを、前記拡張したバルーンが、受け入れるように構成されている、装置。 - 前記アクチュエータは、10〜30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10〜30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または2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2mmの長さに沿って前記腎神経伝達を不活性化するように、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、2〜10mmの長さを有する、請求項1から4のいずれかに記載の装置。
- 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1から5のいずれかに記載の、カテーテル。
- 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ている、請求項1から5のいずれかに記載の装置。
- 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から7のいずれかに記載の装置。
- 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、
ある測定レベルで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から8に記載の装置。 - 前記アクチュエータは、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9に記載の装置。
- 前記衝撃容積は、略円筒状であり、前記腎動脈と略同軸である、請求項1から9のいずれかに記載の装置。
- 前記衝撃容積(V)は、以下の式によって決定される、請求項1から11のいずれかに記載の装置。
式:V=πr22h−πr12h(r1は前記振動子の半径、r2は前記衝撃領域の半径、hは前記振動子の長さ) - 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、
超音波振動子と、
前記超音波振動子に電気的に接続されるアクチュエータと、
前記超音波振動子を包含するように構成された拡張可能なバルーンと、
を備え、
当該超音波振動子は、
前記哺乳類対象の腎動脈へ挿入され、
治療用量の非集束超音波エネルギーを、前記腎動脈へ伝達し、
前記アクチュエータは、
前記腎動脈を包含する少なくとも0.5cm3の衝撃容積内に、当該腎動脈の内膜層を損傷させることなく、前記衝撃容積全体の腎神経伝達を不活性化するために、治療用量の非集束超音波エネルギーを360度の円筒形態で伝達するように、前記超音波振動子を制御し、
前記超音波振動子及び前記腎動脈の内面を冷却するために、拡張された前記バルーンを通じる冷却された液体の流れの循環を制御するように構成されている、装置。
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