JP2022084785A - 遠位側に延在するコイルおよび成形可能な先端部を有するガイドワイヤデバイス - Google Patents
遠位側に延在するコイルおよび成形可能な先端部を有するガイドワイヤデバイス Download PDFInfo
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Abstract
【解決手段】ガイドワイヤデバイス100が、近位側セクション110と、テーパ状の遠位側セクション112とを有するコア102を有する。チューブ構造104がコア102に結合され、その結果、コア102のテーパ状の遠位側セクション112がチューブ構造104の中まで延在し、チューブ構造104を越えて遠位側へと延在する。チューブ104を越えて遠位側へと延在するコア102の一部分が成形可能な先端部106を形成する。また、1つまたは複数のコイル114,118がチューブ104を越えて遠位側へと延在する。先端部106が、チューブ構造104からの弾性力により先端部106のカスタマイズされた形状が乱される傾向を低減するように構成される。
【選択図】図2
Description
[0001]本出願は、「GUIDEWIRE DEVICES HAVING DISTALLY EXTENDING COILS AND SHAPEABLE TIPS」と題される、2017年6月1日に出願された米国特許出願第15/611,328号、および「GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS」と題される、2016年7月18日に出願された米国仮特許出願第62/363,760号の優先権および利益を主張するものである。上で言及したすべての出願はその全体が参照により本明細書に組み込まれる。
[0017]本開示は、有効な解剖学的ナビゲーション能力(anatomical navigation capability)を提供するガイドワイヤデバイスに関連する。ガイドワイヤを操作して標的の解剖学的ロケーションまで移動させる能力は、トルク伝達性と成形先端部を維持するための能力との間のバランスを維持しながらそれらの間のトレードオフを最適化することに依存する。ガイドワイヤデバイスが、手術者が遠位側先端部を回転させることにより先端部を脈管構造内の所望の方向に向けるのを可能にするための成形可能な先端部を有することができる。しかし、このようなガイドワイヤデバイスのトルク伝達性が不十分である場合、成形遠位側先端部の向きを制御するために手術者がねじり力を常に成形遠位側先端部まで伝達することが不可能となる。このような障害は、脈管構造の中へとさらにガイドワイヤデバイスが前進させられてより大きい摩擦抵抗を受けるときにその問題性が増大する。加えて、ガイドワイヤデバイスが成形先端部を適切に形成および維持することができない場合、先端部の向きを調節するためのガイドワイヤデバイスの能力を制限することになり、脈管構造内でのナビゲーションがより困難なものとなる。
配備中の手術者の操作に対して応答的であり、伝達されるねじり力を成形遠位側先端部が受けるのを可能にすることにより有効なナビゲーション能力を提供する。
成形可能な先端部を有するガイドワイヤデバイス
[0020]図1および2が、有効な成形可能な先端部を有する例示のガイドワイヤデバイス100を示す。図1がデバイスの側面図を示し、図2がデバイスの断面図を示す。ガイドワイヤデバイス100がコア102を有する。チューブ104がコア102に結合され、コア102に取り付けられるポイントから遠位側に延在する。示されるように、コア102の遠位側セクションがチューブ104の中まで延在し、チューブ104によって囲まれる。いくつかの実施形態では、コア102が1つまたは複数のテーパ状セクションを有し、その結果、コア102がチューブ104の中に嵌合されてチューブ104の中まで延在することができる。例えば、コア102の遠位側セクションが、漸進的に先細となり遠位端のところでより小さい直径となるように研削され得る。この実施例では、コア102およびチューブ104が取り付けポイント103のところで実質的に同等の外径を有し、取り付けポイント103のところでコア102およびチューブ104が互いに隣接して取り付けられる。
形態では、チューブ104が約3から100cm(約1.18から39.37インチ)の範囲内にある長さを有する。チューブ104がニチノールなどの超弾性材料から形成され得、および/またはニチノールなどの超弾性材料を含むことができる。別法として、チューブ104が線形弾性材料から形成され得、および/または線形弾性材料を含み得る(例えば、少なくとも約6%の復元可能なひずみ(recoverable strain)を有する)。チューブ104を越えて遠位側に延在するデバイスの部分(先端部106と称される)が、約0.5から5cmの長さ、または約1から3cmの長さを測定することができる。
、内側コイル114が1つの一体部片として形成される。他の実施形態では、内側コイル114が、互いに隣接して位置決めされる、および/または撚り合わせコイルを介してインターロックされる複数の別個のセクションを有する。加えてまたは別法として、このような別個のセグメントが、完全な内側コイル114を形成するように、互いに、はんだ付けされ得るか、接着され得るか、または他の形で固定され得る。
切欠部パターン
[0036]図3から8が、本明細書で説明されるガイドワイヤデバイスの実施形態うちの1つまたは複数の実施形態で利用され得るチューブ切欠部パターンの例示の実施形態を示す。例えば、図1および2に示される実施形態のチューブ104が、図3から8に示される構成のうちの1つまたは複数の構成に従って切削され得る。
側セクションを有することができ、この近位側セクションは相対的に高い可撓性および相対的に低いトルク伝達性を有する遠位側セクションへと急激な形で移行する。好都合には、このような切欠部パターンによって提供される可撓性により、チューブがガイドワイヤの内部構造(例えば、コア)の形状を変形させることが最小となるかまたは防止され得、その結果、先端部のカスタマイズされる形状がより良好に形成されて維持され得る。
うように配設される。
先端部の変形形態
[0047]図9から11が、本明細書で説明される実施形態のうちの1つまたは複数の実施形態と共に利用され得る種々の遠位側先端部の構成の実施形態を示す。図9が連続的な直径の先端部構成を示す。ここでは、テーパ状のコア902を囲むコイル918が実質的に連続的な直径を有する。図10が段のある先端部構成を示し、ここでは、コア1002の上に位置決めされる外側コイル1018が実質的に連続的な直径を有する。より小さい直径の内側コイル1014が、先端部の階段状に変化する直径を提供するように、外側コイル1018よりさらに遠位側に延在するように位置決めされる。図11がテーパ状の先端部構成を示しており、ここでは、コイル1118がコア1102の少なくとも一部分のテーパ部分に適合するように先細となる。図9から11に示される先端部の実施形態が、本明細書で説明されるガイドワイヤデバイスの実施形態のうちの任意の実施形態と組み合わされ得る。例えば、所望の先端部構成が、所与のガイドワイヤの用途のための所望の成形可能性特性および/または可撓性特性を提供するように選択され得る。
化され得る。説明される実施形態は、あらゆる点において、単に例示的なものであり、限定的なものではないとみなされる。したがって、本発明の範囲は、上記の説明ではなく、添付の特許請求の範囲によって示される。特許請求の範囲の意義の範囲内およびその均等物の範囲内にあるすべての変更形態が本発明の範囲に含まれる。
Claims (20)
- 成形可能な先端部を有するガイドワイヤデバイスであって、前記ガイドワイヤデバイスが、
近位側セクションおよび遠位側セクションを有するコアであって、前記遠位側セクションが前記近位側セクションより小さい直径を有する、コアと、
前記コアに結合されるチューブ構造であって、その結果、前記コアの前記遠位側セクションが前記チューブ構造の中まで通過し、前記チューブ構造を越えて遠位側へと通過し、成形可能な先端部を形成する、チューブ構造と、
前記先端部の少なくとも一部分を包囲する1つまたは複数のコイルと
を備える
ガイドワイヤデバイス。 - 前記コアの前記遠位側セクションが前記コアの前記近位側セクションから先細となる、請求項1に記載のガイドワイヤデバイス。
- 前記成形可能な先端部が、約0.5cmから5cm、または約1cmから3cmの距離で前記チューブ構造を越えて遠位側へと延在する、請求項1に記載のガイドワイヤデバイス。
- 前記1つまたは複数のコイルが、前記チューブ構造の遠位端に結合され、前記チューブ構造から遠位側へと延在する外側コイルを有する、請求項1に記載のガイドワイヤデバイス。
- 前記外側コイルが、ニチノールと比較してより弾性的に変形可能である材料から形成される、請求項4に記載のガイドワイヤデバイス。
- 前記外側コイルがステンレス鋼から形成される、請求項5に記載のガイドワイヤデバイス。
- 前記1つまたは複数のコイルが前記チューブ構造内に少なくとも部分的に配設される内側コイルを有し、前記外側コイルが、前記チューブ構造を越えて遠位側へと延在する前記内側コイルの少なくとも一部分を包囲する、請求項4に記載のガイドワイヤデバイス。
- 前記1つまたは複数のコイルが、前記コアの外側表面と前記チューブ構造の内側表面との間に位置決めされるように前記チューブ構造内に少なくとも部分的に配設される内側コイルを有する、請求項1に記載のガイドワイヤデバイス。
- 前記内側コイルが前記コアと前記チューブ構造との間の空間の中を満たすようにサイズおよび形状を構成され、その結果、前記チューブ構造の湾曲時に前記チューブ構造の湾曲部分が前記コアの一致する部分の湾曲部分に位置合わせされる、請求項8に記載のガイドワイヤデバイス。
- 前記内側コイルがX線不透過材料から形成される、請求項8に記載のガイドワイヤデバイス。
- 前記内側コイルが白金から形成される、請求項10に記載のガイドワイヤデバイス。
- 前記チューブ構造がニチノールから形成される、請求項1に記載のガイドワイヤデバイス。
- 前記コアがステンレス鋼から形成される、請求項1に記載のガイドワイヤデバイス。
- 前記チューブ構造が、円周方向に延在する複数のリングを結合する軸方向に延在する複数のビームを画定する複数の窓を有する、請求項1に記載のガイドワイヤデバイス。
- 前記複数の窓が、ワンビーム切欠部パターン、ツービーム切欠部パターン、またはスリービーム切欠部パターン、のうちの1つまたは複数の切欠部パターンとなるように構成される、請求項14に記載のガイドワイヤデバイス。
- 前記窓が、前記チューブ構造の長さ方向に沿う連続する各セグメントを1つ前のセグメントから円周方向に回転させるような回転方向のオフセットを有する切欠部パターンを画定する、請求項14に記載のガイドワイヤデバイス。
- 前記窓が、前記チューブ構造の遠位端に向かって増大する深さを有する切欠部を有する、および/または前記チューブ構造の遠位端に向かって縮小する連続する切欠部の間の間隔を有する、切欠部パターンを画定する、請求項14に記載のガイドワイヤデバイス。
- 成形可能な先端部を有するガイドワイヤデバイスであって、前記ガイドワイヤデバイスが、
近位側セクションおよび遠位側セクションを有するコアであって、前記遠位側セクションが前記近位側セクションより小さい直径を有する、コアと、
前記コアに結合されるチューブ構造であって、その結果、前記コアの前記遠位側セクションが前記チューブ構造の中まで通過し、前記チューブ構造を越えて遠位側へと通過し、成形可能な先端部を形成し、ここでは前記チューブ構造が、軸方向に延在する複数のビームと、円周方向に延在する複数のリングとを画定する複数の窓を有する、チューブ構造と、
前記コアの前記遠位側セクションの少なくとも一部分を包囲する内側コイルであって、前記内側コイルの一部分が、前記コアの外側表面と前記チューブ構造の内側表面との間に配設され、前記内側コイルの一部分が、前記先端部の少なくとも一部分を包囲するように前記チューブ構造を越えて遠位側へと延在する、内側コイルと、
前記チューブ構造の遠位端に結合され、前記チューブ構造から遠位側へと延在する外側コイルであって、前記外側コイルが、前記チューブ構造を越えて遠位側へと延在する前記内側コイルの前記一部分を包囲する、外側コイルと
を備える
ガイドワイヤデバイス。 - 前記内側コイルおよび前記外側コイルが、前記先端部のところの前記コアに、無効にするように働く復元力を受けさせないように、構成される、請求項18に記載のガイドワイヤデバイス。
- 成形可能な先端部を有するガイドワイヤデバイスを使用する方法であって、前記方法が、
ガイドワイヤデバイスを提供するステップであって、前記ガイドワイヤデバイスが、
近位側セクションおよび遠位側セクションを有するコアであって、前記遠位側セクションが前記近位側セクションより小さい直径を有する、コアと、
前記コアに結合されるチューブ構造であって、その結果、前記コアの前記遠位側セクションが前記チューブ構造の中まで通過し、前記チューブ構造を越えて遠位側へと通過し、成形可能な先端部を形成し、ここでは前記チューブ構造が、軸方向に延在する複数のビームと、円周方向に延在する複数のリングとを画定する複数の窓を有する、チューブ
構造と、
前記コアの前記遠位側セクションの少なくとも一部分を包囲する内側コイルであって、前記内側コイルの一部分が、前記コアの外側表面と前記チューブ構造の内側表面との間に配設され、前記内側コイルの一部分が、前記先端部の少なくとも一部分を包囲するように前記チューブ構造を越えて遠位側へと延在する、内側コイルと、
前記チューブ構造の遠位端に結合され、前記チューブ構造から遠位側へと延在する外側コイルであって、前記外側コイルが、前記チューブ構造を越えて遠位側へと延在する前記内側コイルの前記一部分を包囲する、外側コイルと
を有する、ステップと、
前記先端部を成形するステップと、
前記ガイドワイヤデバイスを患者の脈管構造の中まで送るステップと
を含む、方法。
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