JP2005537051A - 血管閉塞を破壊するための超音波カテーテル - Google Patents
血管閉塞を破壊するための超音波カテーテル Download PDFInfo
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Abstract
Description
本発明は、一般に医療デバイスおよび方法に関する。詳細には、本発明は、閉塞性血管内障害を治療するための超音波カテーテルデバイスおよび方法に関する。
本発明の超音波カテーテルデバイスおよび方法は、血管の閉塞の強化された破壊を提供する。一般に、超音波カテーテルは、1個以上のルーメンを有する長形の可撓性カテーテル本体を備える。超音波伝達部材またはワイヤは、カテーテル本体のルーメンを通って長軸方向延び、多くの実施形態では、ガイドワイヤの管も、同じルーメンを通って延びる。遠位ヘッドは、超音波伝達部材またはワイヤの遠位端に固定されるか、さもなければ機械的に結合され、カテーテル本体の遠位端に隣接して配置される。カテーテル本体の遠位端は、多くの場合、遠位ヘッドに重畳し、遠位ヘッドは、カテーテル本体の遠位端に直接的には固着されない。したがって、遠位先端は、超音波エネルギーが超音波伝達部材を介して印加される場合、カテーテル本体の遠位端に対して自由に移動する(または「浮動する」)。
本発明の超音波カテーテルデバイスおよび方法は、全体として、石灰化閉塞を含む血管内閉塞のアブレーションおよび破壊を行なう。ワイヤなどの超音波エネルギー伝達部材は、一般に、エネルギーを超音波変換器からカテーテルの遠位ヘッドに伝達する。伝達されるエネルギーは遠位ヘッドを振動させ、こうした振動エネルギーは、血管の閉塞をアブレートするために使用される。一般に、超音波カテーテルの遠位ヘッドは、カテーテル本体に直接的には固着されず、その結果、遠位ヘッドはカテーテル本体の遠位端に対して、自由に移動する(つまり、「浮動する」)。こうした移動の自由は、エネルギー伝達効率を増加させ、超音波伝達ワイヤに対する応力を減少させ、その結果、ワイヤの磨耗および引裂並びに永久的な破損を減少させる。さらに、遠位ヘッドに固着されないため、より大きいアブレーション能力を提供し、石灰化閉塞を破壊することができる。
Claims (49)
- 血管内の閉塞を破壊するための超音波カテーテルであって、該超音波カテーテルは以下:
近位端、遠位端および少なくとも1個のルーメンを有する長形の可撓性カテーテル本体;
カテーテル本体のルーメンを通って長軸方向に延びる超音波伝達部材であって、別個の超音波発生デバイスに接続可能な近位端およびカテーテル本体の遠位端に隣接して終端する遠位端とを有する超音波伝達部材;ならびに
超音波伝達部材の遠位端に結合された遠位ヘッドであって、該遠位ヘッドは、カテーテル本体の遠位端に隣接して配置され、ただし、直接的には固着されない、遠位ヘッド、
を備える、超音波カテーテル。 - カテーテル本体のルーメンの少なくとも一部分を通って長軸方向に延び、前記遠位ヘッドを通って長軸方向に延びるガイドワイヤの管をさらに備える、請求項1に記載の超音波カテーテル。
- 前記ガイドワイヤの管が前記遠位ヘッドに固着される、請求項2に記載の超音波カテーテル。
- 前記ガイドワイヤの管が、前記カテーテル本体にさらに固着される、請求項3に記載の超音波カテーテル。
- 前記ガイドワイヤの管が、前記カテーテル本体の遠位端から約25cmの位置において、前記カテーテル本体に固着される、請求項4に記載の超音波カテーテル。
- 前記ガイドワイヤの管が、前記カテーテル本体の遠位端から約1cm以内の位置において、前記カテーテル本体にさらに固着される、請求項5に記載の超音波カテーテル。
- 前記遠位ヘッドの一部分の周囲に配置されたポリマースリーブをさらに備え、該ポリマースリーブが、前記遠位ヘッドの側面開口部を通して、前記ガイドワイヤの管と結合する、請求項4に記載の超音波カテーテル。
- 前記ポリマースリーブが、前記遠位ヘッド側面開口部を通して延びる接着剤を介して、前記ガイドワイヤの管に結合される、請求項7に記載の超音波カテーテル。
- 前記遠位ヘッドが、金属およびポリマーからなる群から選択された材料を含む、請求項1に記載の超音波カテーテル。
- 前記遠位ヘッドが、その視認性を改善するために、少なくとも1個の放射性マーカー材料をさらに備える、請求項1に記載の超音波カテーテル。
- 前記遠位ヘッドが、前記超音波伝達部材の遠位端上に形成された球状部材を備える、請求項1に記載の超音波カテーテル。
- 前記カテーテル本体の遠位端が、前記遠位ヘッドの少なくとも一部分に重なり合う、請求項1に記載の超音波カテーテル。
- 前記遠位ヘッドが、以下;
前記カテーテル本体の外径にほぼ等しい直径を有し、前記カテーテル本体の遠位端を越えて延びる球状遠位部分;および
前記遠位部分の直径より小さい直径を有する近位部分であって、前記カテーテル本体の遠位端内に取り付けられるが、該カテーテル本体の遠位端に直接的には固着されない近位部分とを備える、
請求項12に記載の超音波カテーテル。 - 前記遠位ヘッドが、前記カテーテル本体の遠位端付近において、前記カテーテル本体の前記ルーメン内に完全に配置される、請求項12に記載の超音波カテーテル。
- 前記カテーテル本体の遠位端が、前記遠位ヘッドの近位端に隣接し、前記遠位ヘッドが、前記カテーテル本体の外径にほぼ等しい直径を有する、請求項1に記載の超音波カテーテル。
- 請求項1に記載の超音波カテーテルであって、該超音波カテーテルは、前記遠位端付近の前記ルーメン内で、前記カテーテル本体と結合する遠位スリーブをさらに備え、該スリーブが、前記超音波伝達ワイヤの一部分を包囲する中空円筒状部材を備える、超音波カテーテル。
- 前記遠位スリーブが、接着剤により、前記ルーメン内において前記カテーテル本体と結合する、請求項16に記載の超音波カテーテル。
- 前記カテーテル本体の前記ルーメン内に配置された固定部材をさらに備え、該固定部材が、前記遠位ヘッドに結合する遠位端および該カテーテル本体に結合する近位端を有する、請求項1に記載の超音波カテーテル。
- 前記超音波伝達部材が合金から形成される、請求項1に記載の超音波カテーテル。
- 前記合金が超弾性合金である、請求項19に記載の超音波カテーテル。
- 請求項1に記載の超音波カテーテルであって、該超音波カテーテルは、前記カテーテル本体の遠位端付近に位置する少なくとも1個の流体出口ポートをさらに備え、該流体出口ポートが、該カテーテル本体の少なくとも1個のルーメンと連通し、該ルーメンの近位端内に注入される流体が、該ルーメンを長軸方向に通過して、少なくとも1個の該流体出口ポートから流出する、請求項1に記載の超音波カテーテル。
- 前記カテーテル本体の少なくとも1個のルーメンが、超音波伝達部材の通過のための単一のルーメンおよびガイドワイヤの管を備える、請求項1に記載の超音波カテーテル。
- 請求項1に記載の超音波カテーテルであって、該超音波カテーテルは、前記カテーテル本体の前記近位端に結合する近位端コネクタアセンブリをさらに備え、該近位端コネクタアセンブリが;
該カテーテル本体の近位端に結合し、中空ボアを有し、該中空ボアが、該カテーテル本体の少なくとも1個のルーメンと連通し、前記超音波伝達部材が、該カテーテル本体から該中空ボアの少なくとも一部分を通って近位に延びる長形剛性本体;
該超音波伝達部材の周囲を囲む中空ボア内に配置され、振動を吸収するための1個以上の吸収部材;および
該近位端コネクタアセンブリの近位端上にある音響コネクタ装置であって、前記超音波伝達部材を別個の超音波発生装置に接続し、その結果、超音波エネルギーが、超音波伝達部材を通って前記遠位ヘッドに伝達される音響コネクタ装置、
を備える、超音波カテーテル。 - 前記1個以上の吸収部材が環状部材を備える、請求項23に記載の超音波カテーテル。
- 前記環状部材がOリングを備える、請求項24に記載の超音波カテーテル。
- 前記近位コネクタ装置の前記ボアを通し、前記カテーテル本体の前記ルーメンを通して流体を注入するための少なくとも1個の流体入口開口部をさらに備える、請求項23に記載の超音波カテーテル。
- ガイドワイヤを、前記近位コネクタ装置のボアおよび前記カテーテル本体のガイドワイヤルーメン内に導入することを可能にするため、少なくとも1個のガイドワイヤ開口部をさらに備える、請求項23に記載の超音波カテーテル。
- 前記超音波伝達部材が、その遠位端付近に少なくとも1つのテーパした領域を備える、請求項1に記載の超音波カテーテル。
- 前記超音波伝達部材が、前記少なくとも1つのテーパした領域により分離された近位部分および遠位部分を備える、請求項28に記載の超音波カテーテル。
- 前記近位部分および前記遠位部分の各々が、前記少なくとも1つのテーパした領域より大きい断面直径を有する、請求項29に記載の超音波カテーテル。
- 前記近位部分が前記遠位部分より大きい直径を有する、請求項29に記載の超音波カテーテル。
- 前記超音波伝達部材が金属ワイヤを備え、該金属ワイヤ上に形成した減摩コーティングを有する、請求項1に記載の超音波カテーテル。
- 前記コーティングがポリマー材料を含有する、請求項32に記載の超音波カテーテル。
- 前記コーティングがポリテトラフルオロエチレンを含有する、請求項33に記載の超音波カテーテル。
- 前記コーティングがポリエチレンを含有する、請求項33に記載の超音波カテーテル。
- 前記コーティングが、前記超音波伝達部材の少なくとも一部分を包囲する管状ジャケットを備える、請求項32に記載の超音波カテーテル。
- 前記コーティングが、前記超音波伝達部材の全長にわたって延びる、請求項32に記載の超音波カテーテル。
- 前記コーティングが、前記超音波伝達部材の長軸方向の全長より少ない長さを被覆する、請求項32に記載の超音波カテーテル。
- 血管内の閉塞を破壊するための超音波カテーテルであって、該超音波カテーテルが、
近位端、遠位端および少なくとも1個のルーメンを有する長形の可撓性カテーテル本体と、
前記カテーテル本体の前記ルーメンを通って長軸方向に延びる超音波伝達部材であって、別個の超音波発生デバイスに接続可能な近位端および前記カテーテル本体の遠位端に隣接して終端する遠位端とを有する超音波伝達部材;および
前記超音波伝達部材の遠位端と結合し、該カテーテル本体の遠位端に隣接して配置されるが、直接的には固着されない遠位ヘッドであって、前記カテーテル本体の遠位端が、前記遠位ヘッドの少なくとも一部分に重なり合う遠位ヘッド、
を備える、超音波カテーテル。 - 血管内の閉塞を破壊するための超音波カテーテルであって、該超音波カテーテルが、
近位端、遠位端および少なくとも1個のルーメンを有する長形の可撓性カテーテル本体;
前記カテーテル本体の前記ルーメンを通って長軸方向に延びる超音波伝達部材であって、別個の超音波発生デバイスに接続可能な近位端および該カテーテル本体の遠位端に隣接して終端する遠位端を有する超音波伝達部材;
該超音波伝達部材の遠位端に結合された遠位ヘッドであって、該カテーテル本体の遠位端に隣接して配置され、ただし直接的には固着されない遠位ヘッド;および
該カテーテル本体の前記近位端に結合される近位端コネクタアセンブリであって、該近位端コネクタアセンブリは以下;
該カテーテル本体の近位端に結合し、中空ボアを有し、該中空ボアが、該カテーテル本体の少なくとも1個のルーメンと連通する長形剛性本体であって、該超音波伝達部材が、該カテーテル本体から該中空ボアの少なくとも一部分を通って延びる長形剛性本体;
該超音波伝達部材の周囲を囲む該中空ボア内に配置され、振動を吸収するための1個以上の吸収部材;および
該近位端コネクタアセンブリの近位端上にある音響コネクタ装置であって、該超音波伝達部材を別個の超音波発生装置に接続し、その結果、超音波エネルギーが、該超音波伝達部材を通って該遠位ヘッドに伝達され得る音響コネクタ装置とを備える、近位端コネクタアセンブリ
を備える、超音波カテーテル。 - 前記1個以上の吸収部材が環状部材を備える、請求項40に記載の超音波カテーテル。
- 前記環状部材がOリングを備える、請求項44に記載の超音波カテーテル。
- 前記近位コネクタ装置のボアを通し、前記カテーテル本体の前記ルーメンを通して流体を注入するための少なくとも1個の流体入口開口部をさらに備える、請求項40に記載の超音波カテーテル。
- 近位端、遠位端および少なくとも1個のルーメンを有する長形の可撓性カテーテル本体、該ルーメンを通って長軸方向に延びる超音波伝達部材および該超音波伝達部材の遠位端と結合する遠位ヘッドを備えるタイプの改良超音波カテーテルであって、改良が、該カテーテル本体の遠位端が該遠位ヘッドの少なくとも一部分に重なり合うが、直接的には該遠位ヘッドに固着されないように配置される遠位ヘッドを提供する工程を包含する、改良超音波カテーテル。
- 血管内の血管の閉塞を破壊するための方法であって、該方法は以下;
閉塞付近の血管内のある位置に、超音波カテーテルの遠位端を配置する工程;
前記カテーテルの遠位ヘッドを前記閉塞に対して係合させる工程であって、該遠位ヘッドが、該カテーテルの遠位端に隣接して配置されるが、該遠位端に直接的には固着されない工程;および、
閉塞に対して係合している状態で、該遠位ヘッドを振動させて該閉塞を破壊する工程、
を包含する、方法。 - 前記遠位端を配置する前記工程が、前記カテーテルをガイドワイヤ上に通す工程を包含する、請求項45に記載の方法。
- 前記遠位ヘッドを振動させる工程が、エネルギーを伝達して、20kHzと40kHzとの間の周波数で、該遠位ヘッドを振動させる工程を包含する、請求項45に記載の方法。
- 前記超音波カテーテル内の少なくとも1個の流体入口開口部を通して、閉塞に隣接するある位置に流体を注入する工程をさらに包含する、請求項45に記載の方法。
- 前記遠位ヘッド内の少なくとも1個の流体入口開口部を通して、前記血管の閉塞に隣接するある位置に流体を注入する工程をさらに包含する、請求項45に記載の方法。
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US7621902B2 (en) | 2009-11-24 |
JP2010221064A (ja) | 2010-10-07 |
EP1553996A4 (en) | 2010-12-29 |
US8690819B2 (en) | 2014-04-08 |
US9770250B2 (en) | 2017-09-26 |
EP1553996B1 (en) | 2017-03-15 |
WO2004018019A2 (en) | 2004-03-04 |
US20130072824A1 (en) | 2013-03-21 |
US8308677B2 (en) | 2012-11-13 |
WO2004018019A3 (en) | 2004-05-27 |
US20040039311A1 (en) | 2004-02-26 |
US20070021691A1 (en) | 2007-01-25 |
JP4783014B2 (ja) | 2011-09-28 |
US20140214064A1 (en) | 2014-07-31 |
AU2003262952A1 (en) | 2004-03-11 |
US9314258B2 (en) | 2016-04-19 |
US10376272B2 (en) | 2019-08-13 |
US20110237983A1 (en) | 2011-09-29 |
EP1553996A2 (en) | 2005-07-20 |
US7955293B2 (en) | 2011-06-07 |
US20070021690A1 (en) | 2007-01-25 |
US20160242797A1 (en) | 2016-08-25 |
JP5178780B2 (ja) | 2013-04-10 |
US7137963B2 (en) | 2006-11-21 |
US20170354428A1 (en) | 2017-12-14 |
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