JP2008510573A - 改良型超音波カテーテルデバイスおよび方法 - Google Patents
改良型超音波カテーテルデバイスおよび方法 Download PDFInfo
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- A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
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Abstract
Description
本発明の一局面において、血管内の閉塞物を破壊するための超音波カテーテルは、以下:細長い可撓性カテーテル本体であって、近位端、遠位端および少なくとも1つの内腔を有する、細長い可撓性カテーテル本体;超音波伝送部材であって、カテーテル本体の内腔を通って長軸方向に延び、近位端および遠位端を有する、超音波伝送部材;遠位ヘッドであって、超音波伝送部材の遠位端と連結され、カテーテル本体の遠位端に隣接して配置される、遠位ヘッド;ソニックコネクタ(sonic connector)であって、超音波伝送部材を超音波変換器デバイスと連結するために、超音波伝送部材の近位端と連結される、ソニックコネクタ;ならびに近位ハウジングであって、カテーテル本体の近位端と連結され、ソニックコネクタおよび超音波伝送ワイヤの近位部分を収容する、近位ハウジング、を備える。この近位ハウジングは、超音波伝送部材の近位部分から熱を放散するために少なくとも1つの熱放散特徴を備える。
本発明の超音波カテーテルデバイスおよび方法は、血管内の閉塞物の破壊を提供する。カテーテルデバイスは、一般的に、カテーテル本体、そのカテーテル本体内に配置される超音波エネルギー伝送部材、およびそのエネルギー伝送部材と連結されかつカテーテル本体の遠位端にもしくは遠位端の近くに配置される遠位ヘッドを備える。超音波伝送部材は、超音波エネルギーを超音波変換器から遠位ヘッドに伝送し、そのヘッドを振動させ、したがって、脈管閉塞物を破壊する。そのようなカテーテルデバイスの多くの改良された特徴が、以下により完全に記載される。
Claims (75)
- 血管内の閉塞物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、
細長い可撓性カテーテル本体であって、近位端、遠位端および少なくとも1つの内腔を有する、細長い可撓性カテーテル本体;
超音波伝送部材であって、該カテーテル本体の内腔を通って長軸方向に延び、近位端および遠位端を有する、超音波伝送部材;
遠位ヘッドであって、該超音波伝送部材の遠位端と連結され、該カテーテル本体の遠位端に隣接して配置される、遠位ヘッド;
ソニックコネクタであって、該超音波伝送部材を超音波変換器デバイスと連結するために、該超音波伝送部材の近位端と連結される、ソニックコネクタ;ならびに
近位ハウジングであって、該カテーテル本体の近位端と連結され、該ソニックコネクタおよび該超音波伝送ワイヤの近位部分を収容する、近位ハウジング
を備え、
ここで、該近位ハウジングは、該超音波伝送部材の近位部分から熱を放散するために少なくとも1つの熱放散特徴を備える、超音波カテーテル。 - 前記熱放散特徴が、熱伝導性物質から構成される前記ハウジングの1以上の部分を含む、請求項1に記載の超音波カテーテル。
- 前記熱伝導性物質が、金属、ポリマー、ガラス、ゴムおよびそれらの組み合わせからなる群より選択される、請求項2に記載の超音波カテーテル。
- 前記熱放散特徴が、前記ハウジングの表面積を増加させるために該ハウジング上に複数の表面特徴を含む、請求項1または2に記載の超音波カテーテル。
- 前記表面特徴が、溝、ノッチ、ウェーブおよびディップからなる群より選択される、請求項4に記載の超音波カテーテル。
- 前記熱放散特徴が、少なくとも1つの導電性物質を含み、該導電性物質が、熱を前記超音波伝送部材から取り去って伝導するように、前記ハウジング内に配置され、該超音波伝送部材を少なくとも部分的に取り囲む、請求項1または2に記載の超音波カテーテル。
- 前記導電性物質が、前記超音波伝送部材を取り囲む1以上の振動吸収部材に隣接して配置される、請求項6に記載の超音波カテーテル。
- 前記少なくとも1つの導電性物質が、複数の別個の導電性部材を含み、該導電性部材は、複数の振動吸収部材の間に配置され、前記超音波伝送部材を少なくとも部分的に取り囲む、請求項7に記載の超音波カテーテル。
- 前記導電性物質が、前記超音波伝送部材を取り囲む1以上の振動吸収部材の上に配置される、請求項6に記載の超音波カテーテル。
- 前記熱放散特徴が、1以上の熱放散流体が前記ハウジングの内部空洞に入ることを可能にするために、少なくとも1つの流体入口を含む、請求項1に記載の超音波カテーテル。
- 前記ハウジングの内部空洞が、前記カテーテル本体の内腔と流体連絡し、その結果、該内部空洞に導入される流体が該カテーテル本体内腔の遠位端を通過し、該遠位端を出る、請求項10に記載の超音波カテーテル。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する熱放散流体が前記超音波伝送部材の近位部分に接触する、請求項10に記載の超音波カテーテル。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する熱放散流体が前記超音波伝送部材の上に配置される少なくとも1つの振動吸収部材に接触する、請求項10に記載の超音波カテーテル。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する熱放散流体が前記ソニックコネクタおよび前記超音波伝送部材の一部に接触する、請求項10または13に記載の超音波カテーテル。
- 前記流体入口を通って導入されるべき流体を冷蔵するために、前記カテーテルと連結される冷蔵デバイスをさらに備える、請求項10に記載の超音波カテーテル。
- ガイドワイヤの通過を可能にするために、前記カテーテル本体の少なくとも一部を通って延びるガイドワイヤチューブをさらに備える、請求項10に記載の超音波カテーテル。
- 前記ガイドワイヤチューブの側壁が、前記カテーテル本体の内腔に導入される流体が該ガイドワイヤチューブに入り、該ガイドワイヤチューブを通過することを可能にするために、複数の開口部を備える、請求項16に記載の超音波カテーテル。
- 前記近位ハウジングの少なくとも一部が、該ハウジングの温度が変化した場合に色を変化させるのに適合する物質を含む、請求項1に記載の超音波カテーテル。
- 前記物質がサーモクロミック色素を含む、請求項18に記載の超音波カテーテル。
- 前記サーモクロミック色素が、前記ハウジングの温度が約45℃に達した場合に第一の色から第二の色に変化し、該ハウジングの温度が約45℃未満に下がった場合に該第二の色から該第一の色に変化する、請求項19に記載の超音波カテーテル。
- 血管内の閉塞物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、
細長い可撓性カテーテル本体であって、近位端、遠位端および少なくとも1つの内腔を有する、細長い可撓性カテーテル本体;
超音波伝送部材であって、該カテーテル本体の内腔を通って長軸方向に延び、近位端および遠位端を有する、超音波伝送部材;
遠位ヘッドであって、該超音波伝送部材の遠位端と連結され、該カテーテル本体の遠位端に隣接して配置される、遠位ヘッド;
ソニックコネクタであって、該超音波伝送部材を超音波変換器デバイスと連結するために、該超音波伝送部材の近位端と連結される、ソニックコネクタ;
近位ハウジングであって、該カテーテル本体の近位端と連結され、該ソニックコネクタおよび該超音波伝送ワイヤの近位部分を収容する、近位ハウジング;ならびに
該超音波伝送部材から熱を放散するための手段
を備える、超音波カテーテル。 - 前記熱放散手段が、熱伝導性物質から構成される前記ハウジングの1以上の部分を含む、請求項21に記載の超音波カテーテル。
- 前記熱伝導性物質が、金属、ポリマー、ガラス、ゴムおよびそれらの組み合わせからなる群より選択される、請求項22に記載の超音波カテーテル。
- 前記熱放散手段が、前記ハウジングの表面積を増加させるために該ハウジング上に複数の表面特徴を含む、請求項22に記載の超音波カテーテル。
- 前記表面特徴が、溝、ノッチ、ウェーブおよびディップからなる群より選択される、請求項24に記載の超音波カテーテル。
- 前記熱放散手段が、少なくとも1つの導電性物質を含み、該導電性物質が、熱を前記超音波伝送部材から取り去って伝導するように、前記ハウジング内に配置され、該超音波伝送部材を少なくとも部分的に取り囲む、請求項21に記載の超音波カテーテル。
- 前記導電性物質が、前記超音波伝送部材を取り囲む1以上の振動吸収部材に隣接して配置される、請求項26に記載の超音波カテーテル。
- 前記少なくとも1つの導電性物質が、複数の別個の導電性部材を含み、該導電性部材は、複数の振動吸収部材の間に配置され、前記超音波伝送部材を少なくとも部分的に取り囲む、請求項27に記載の超音波カテーテル。
- 前記導電性物質が、前記超音波伝送部材を取り囲む1以上の振動吸収部材の上に配置される、請求項26に記載の超音波カテーテル。
- 前記熱放散手段が、1以上の熱放散流体が前記ハウジングの内部空洞に入ることを可能にするために、少なくとも1つの流体入口を含む、請求項21に記載の超音波カテーテル。
- 前記ハウジングの内部空洞が、前記カテーテル本体の内腔と流体連絡し、その結果、該内部空洞に導入される流体が該カテーテル本体内腔の遠位端を通過し、該遠位端を出る、請求項30に記載の超音波カテーテル。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する熱放散流体が前記超音波伝送部材の近位部分に接触する、請求項30に記載の超音波カテーテル。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する熱放散流体が前記超音波伝送部材の上に配置される少なくとも1つの振動吸収部材に接触する、請求項30に記載の超音波カテーテル。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する熱放散流体が前記ソニックコネクタおよび前記超音波伝送部材の一部に接触する、請求項30または33に記載の超音波カテーテル。
- 前記流体入口を通って導入されるべき流体を冷蔵するために、前記カテーテルと連結される冷蔵デバイスをさらに備える、請求項30に記載の超音波カテーテル。
- ガイドワイヤの通過を可能にするために、前記カテーテル本体の少なくとも一部を通って延びるガイドワイヤチューブをさらに備える、請求項30に記載の超音波カテーテル。
- 前記ガイドワイヤチューブの側壁が、前記カテーテル本体の内腔に導入される流体が該ガイドワイヤチューブに入り、該ガイドワイヤチューブを通過することを可能にするために、複数の開口部を備える、請求項36に記載の超音波カテーテル。
- 前記近位ハウジングの少なくとも一部が、該ハウジングの温度が変化した場合に色を変化させるのに適合する物質を含む、請求項21に記載の超音波カテーテル。
- 前記物質がサーモクロミック色素を含む、請求項38に記載の超音波カテーテル。
- 前記サーモクロミック色素が、前記ハウジングの温度が約45℃に達した場合に第一の色から第二の色に変化し、該ハウジングの温度が約45℃未満に下がった場合に該第二の色から該第一の色に変化する、請求項39に記載の超音波カテーテル。
- 血管内の閉塞物を破壊するための超音波カテーテルシステムであって、該システムは、
超音波カテーテルデバイス;
該超音波カテーテルデバイスと取り外し可能に連結された超音波発生器;および
熱放散流体を冷却するために、該超音波カテーテルデバイスと取り外し可能に連結された流体冷却デバイス
を備え、
該超音波カテーテルデバイスは、
細長い可撓性カテーテル本体であって、近位端、遠位端および少なくとも1つの内腔を有する、細長い可撓性カテーテル本体;
超音波伝送部材であって、該カテーテル本体の内腔を通って長軸方向に延び、近位端および遠位端を有する、超音波伝送部材;
遠位ヘッドであって、該超音波伝送部材の遠位端と連結され、該カテーテル本体の遠位端に隣接して配置される、遠位ヘッド;
ソニックコネクタであって、該超音波伝送部材を超音波変換器デバイスと連結するために、該超音波伝送部材の近位端と連結される、ソニックコネクタ;ならびに
近位ハウジングであって、該カテーテル本体の近位端と連結され、該ソニックコネクタおよび該超音波伝送ワイヤの近位部分を収容する、近位ハウジング
を備え、
ここで、該近位ハウジングは、1以上の該熱放散流体が該ハウジングの内部空洞に入ることを可能にするために、少なくとも1つの流体入口を備える、システム。 - 前記ハウジングの1以上の部分が、熱伝導性物質から構成される、請求項41に記載のシステム。
- 前記熱伝導性物質が、金属、ポリマー、ガラス、ゴムおよびそれらの組み合わせからなる群より選択される、請求項42に記載のシステム。
- 前記ハウジングが、該ハウジングの表面積を増加させるために複数の表面特徴をさらに含む、請求42に記載のシステム。
- 前記表面特徴が、溝、ノッチ、ウェーブおよびディップからなる群より選択される、請求項44に記載の超音波カテーテル。
- 少なくとも1つの導電性物質をさらに備え、該導電性物質が、熱を前記超音波伝送部材から取り去って伝導するように、前記ハウジング内に配置され、該超音波伝送部材を少なくとも部分的に取り囲む、請求項41に記載のシステム。
- 前記導電性物質が、前記超音波伝送部材を取り囲む1以上の振動吸収部材に隣接して配置される、請求項46に記載のシステム。
- 前記少なくとも1つの導電性物質が、複数の別個の導電性部材を含み、該導電性部材は、複数の振動吸収部材の間に配置され、前記超音波伝送部材を少なくとも部分的に取り囲む、請求項47に記載のシステム。
- 前記導電性物質が、前記超音波伝送部材を取り囲む1以上の振動吸収部材の上に配置される、請求項46に記載の超音波カテーテル。
- 前記ハウジングの内部空洞が、前記カテーテル本体の内腔と流体連絡し、その結果、該内部空洞に導入される流体が該カテーテル本体内腔の遠位端を通過し、該遠位端を出る、請求項41に記載のシステム。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する前記熱放散流体が前記超音波伝送部材の近位部分に接触する、請求項41に記載のシステム。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する前記熱放散流体が前記超音波伝送部材の上に配置される少なくとも1つの振動吸収部材に接触する、請求項41に記載のシステム。
- 前記入口が、前記ハウジングに沿って配置され、その結果、該入口を通過する前記熱放散流体が前記ソニックコネクタおよび前記超音波伝送部材の一部に接触する、請求項41または52に記載のシステム。
- ガイドワイヤの通過を可能にするために、前記カテーテル本体の少なくとも一部を通って延びるガイドワイヤチューブをさらに備える、請求項30に記載のシステム。
- 前記ガイドワイヤチューブの側壁が、前記カテーテル本体の内腔に導入される流体が該ガイドワイヤチューブに入り、該ガイドワイヤチューブを通過することを可能にするために、複数の開口部を備える、請求項36に記載の超音波カテーテル。
- 前記近位ハウジングの少なくとも一部が、該ハウジングの温度が変化した場合に色を変化させるのに適合する物質を含む、請求項41に記載の超音波カテーテル。
- 前記物質がサーモクロミック色素を含む、請求項56に記載の超音波カテーテル。
- 前記サーモクロミック色素が、前記ハウジングの温度が約45℃に達した場合に第一の色から第二の色に変化し、該ハウジングの温度が約45℃未満に下がった場合に該第二の色から該第一の色に変化する、請求項57に記載の超音波カテーテル。
- 血管内の閉塞物を破壊するための方法であって、該方法は、
超音波カテーテルの遠位端が該閉塞物に隣接するように、該血管内に該カテーテルを位置決めする工程;
超音波エネルギーを該超音波カテーテルの超音波伝送部材に伝送して、該閉塞物を複数の閉塞物断片に破壊する工程;および
冷却された灌注流体を該超音波カテーテルに通過させて、熱を該超音波伝送部材から放散させる工程
を包含する、方法。 - 前記冷却された流体が、1℃と22℃との間の温度を有する、請求項59に記載の方法。
- 前記冷却された流体が、生理食塩水、血栓溶解剤、抗血小板薬、溶解剤および抗凝固剤からなる群より選択される、請求項59に記載の方法。
- 前記超音波カテーテルと連結された冷蔵デバイスを用いて前記灌注流体を所望の温度に冷却する工程をさらに包含する、請求項59に記載の方法。
- 前記冷却された流体が、閉塞物破壊手順の間に、前記超音波カテーテルを連続的に通過する、請求項59に記載の方法。
- 前記超音波カテーテルが作動されている間、前記冷却された流体が該カテーテルを通過し、該超音波カテーテルが作動停止されたときに流体の通過が自動的に停止する、請求項59に記載の方法。
- 血管内の閉塞物を破壊するための方法であって、該方法は、
超音波カテーテルの遠位端が該閉塞物に隣接するように、該血管内に該カテーテルを位置決めする工程;
超音波エネルギーを該超音波カテーテルの超音波伝送部材に伝送して、該閉塞物を複数の閉塞物断片に破壊する工程;および
酸素過飽和の灌注流体を該超音波カテーテルに通過させて、熱を該超音波伝送部材から放散させる工程
を包含する、方法。 - 前記酸素過飽和の灌注流体が、酸素過飽和の生理食塩水溶液を含む、請求項65に記載の方法。
- 前記酸素過飽和の灌注流体が、放射線不透過性造影物質と混合された生理食塩水を含む、請求項65に記載の方法。
- 前記酸素過飽和の灌注流体が、室温とおよそ同じ温度を有する、請求項65に記載の方法。
- 前記酸素過飽和の灌注流体が、1℃と22℃との間の温度を有する、請求項65に記載の方法。
- 血管内の閉塞物を破壊するための方法であって、該方法は、
超音波カテーテルの遠位端が該閉塞物に隣接するように、該血管内に該カテーテルを位置決めする工程;
超音波エネルギーを該超音波カテーテルの超音波伝送部材に伝送して、該閉塞物を複数の閉塞物断片に破壊する工程;および
潤滑性灌注流体を該超音波カテーテルに通過させて、熱を該超音波伝送部材から放散させ、かつ該超音波伝送部材と超音波カテーテル本体との間の摩擦を減少させる工程
を包含する、方法。 - 前記潤滑性灌注流体がエマルジョンを含む、請求項70に記載の方法。
- 前記エマルジョンが、オリーブ油、卵黄、リン脂質、グリセリン、デオキシコール酸ナトリウム、L−ヒスチジン、CDTA二ナトリウム、水酸化ナトリウムおよび水を含む、請求項71に記載の方法。
- 前記エマルジョンが、8.0と9.0との間のpHを有する、請求項71に記載の方法。
- 前記潤滑性灌注流体が、室温とおよそ同じ温度を有する、請求項70に記載の方法。
- 前記潤滑性灌注流体が、1℃と22℃との間の温度を有する、請求項70に記載の方法。
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JP2014113495A (ja) * | 2012-12-11 | 2014-06-26 | Biosense Webster (Israel) Ltd | ガイドワイヤを有するラッソーカテーテル |
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JP2021502171A (ja) * | 2017-11-10 | 2021-01-28 | シー・アール・バード・インコーポレーテッドC R Bard Incorporated | カテーテル用ヒートシンクならびにそのシステムおよび方法 |
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JP2022088636A (ja) * | 2017-11-10 | 2022-06-14 | シー・アール・バード・インコーポレーテッド | カテーテル用ヒートシンクならびにそのシステムおよび方法 |
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JP7339388B2 (ja) | 2017-11-10 | 2023-09-05 | シー・アール・バード・インコーポレーテッド | カテーテル用ヒートシンクならびにそのシステムおよび方法 |
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US20060047239A1 (en) | 2006-03-02 |
JP4875621B2 (ja) | 2012-02-15 |
US20140081288A1 (en) | 2014-03-20 |
US20090216246A1 (en) | 2009-08-27 |
US10004520B2 (en) | 2018-06-26 |
EP1793747A2 (en) | 2007-06-13 |
US7540852B2 (en) | 2009-06-02 |
EP1793747A4 (en) | 2011-10-05 |
US8790291B2 (en) | 2014-07-29 |
US10682151B2 (en) | 2020-06-16 |
WO2006026207A3 (en) | 2006-10-05 |
US20180280044A1 (en) | 2018-10-04 |
US8617096B2 (en) | 2013-12-31 |
ES2663681T3 (es) | 2018-04-16 |
EP1793747B1 (en) | 2018-01-10 |
US20110125164A1 (en) | 2011-05-26 |
WO2006026207A2 (en) | 2006-03-09 |
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