JP2020521552A - 非らせんカット配列を有する微細加工医療デバイス - Google Patents
非らせんカット配列を有する微細加工医療デバイス Download PDFInfo
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Abstract
【選択図】図5
Description
[0001]本出願は、2017年5月26日に出願された、名称が「Micro−Fabricated Medical Device having a Distributed Cut Arrangement」である米国仮特許出願第62/511,605号、および2017年12月6日に出願された、名称が「Micro−Fabricated Medical Device having a Non−Helical Cut Arrangement」である米国仮特許出願第62/595,425号に対する優先権およびそれらについての利益を主張する。上記出願の全ては、その全体が参照によって本明細書に組み込まれる。
[0024]本開示は、可撓性を提供する微細加工された特徴を有し、同時にまた曲がりくねった血管系を通して有効にナビゲートするための有効なトルク能力および押す能力を維持するガイドワイヤおよびカテーテル等の介入的デバイスに関する。ここでいう微細加工された特徴とは、介入的デバイスの可撓性を増加させ、同時に良好なトルク能力を維持しながら好ましい曲げ方向を形成することがないように配列された穿孔を形成するカットパターンを含む。
介入的デバイスの概要
[0030]図1は、ハンドルまたはハブ102と、細長い部材104と、を含む介入的デバイス100(例えば、カテーテルまたはガイドワイヤデバイス)を示す。細長い部材104は、ハブ102に結合された近位端106と、ハブ102から離れる方に延びる遠位端108と、を有する。ハブ102は、パドル、ハンドル、グリップまたはユーザが装置を把持して、装置100を回転させ、押し/引きし、および別様に操作することを可能にするようなものを含んでもよい。細長い部材104は、ガイドワイヤとしてまたはカテーテルとして形成されてもよい。ガイドワイヤ等のいくつかの実施形態は、ハブ102を省略してもよく、そして、トルクデバイス等の付属物と共に用いられてもよい。
カットパターン
[0038]図3A〜3Cは、直線カットパターンについての実施形態を示し、図3Aは、典型的な「2−ビーム」直線カットパターンを示し、図3Bは、典型的な「1−ビーム」直線カットパターンを示し、図3Cは、典型的な「3−ビーム」直線カットパターンを示す。
分散パターン
[0050]図5は、分散カットパターンを有する細長い部材500のセクションを示す。
カットは、それぞれのビーム対の回転方向間隔を効果的に分散させるように有益に配列されている。この態様において、非らせんおよび非線形カットパターンは、細長い部材500の長さに沿った好ましい曲げ方向を有効に除去または最小化する。図5に表すカットパターンは、らせんカットパターンと対照的に、細長い部材500の結果として得られるビームが細長い部材500の軸線のまわりにらせんパターンで配列されないので、「非らせん」である。
不完全ランプパターン
[0064]図6Bは、一連の目的をもって設計された不完全を有する他のらせんパターンを意図的に混乱させることによって形成された非らせんカットパターンの他の実施形態をグラフで示す。このタイプのカットパターンは、本明細書中で「不完全ランプ」パターンと呼ばれる。有益なことに、不完全ランプパターンの意図的な逸脱は、真のらせん配置に固有の好ましいねじれおよび湾曲の残存物を減少または防ぐように働く。図示するように、セグメントは、3つの連続するビーム対またはセグメントが同じ回転オフセットに従って間隔をおいて配置されないように配置される。言い換えると、3つのビーム対またはセグメントは、円筒形の長い部材が平面に展開された場合に、直線を形成するように配置されない。
のこぎり歯状パターン
[0069]図6Cは、本明細書中で「のこぎり歯状」パターンと呼ばれる非らせんカットパターンの他の実施形態を示す。本明細書中に説明される他の非らせんカットパターンと同様に、有益なことに、のこぎり歯状カットパターンは、らせんパターンに固有の好ましい湾曲方向も制限しつつ、好ましい曲げ軸を避けることができる。らせんパターンとは対照的に、のこぎり歯状カットパターンは、回転オフセットの方向を周期的に逆にさせる。
間隔の人為構造
[0074]図7は、回転オフセット制限が適用されない場合に生じ得る望ましくない間隔の人為構造の一例を示す。図7は、第1のセグメント750aおよび第2のセグメント750bを有する細長い部材700のセクションを示す。第1のセグメント750aは、第1の対のビーム730a(それらのうちのたった1つがこの図に見える)と、第1の対から90度だけオフセットされている第2の対のビーム730bおよび730cとを備える。第2のセグメント750bは、第1の対のビーム730dおよび730eと、第1の対から90度だけオフセットされている第2の対のビーム730fおよび730gとを備える。対内の各ビームは、その対応するビームから180度だけ周方向に間隔をおいて配置される。第2のセグメント750bは、第1のセグメント750aから45度だけオフセットされ、これは、第1の対のビーム730dおよび730eを第1の対のビーム730aから45度だけずらして配置し、第2の対のビーム730fおよび730fを第2の対のビーム730bおよび730cから45度だけずらして配置する。
Claims (45)
- 壁および内部管腔を有する細長い部材であって、前記壁を通って延び前記管腔を露出させる複数の穿孔を含み、前記複数の穿孔は、複数の軸方向に延びるビームおよび複数の周方向に延びるリングを画定する、細長い部材を備え、
前記ビームは、前記細長い部材の長さに沿って配列されて、非らせんおよび非直線パターンを形成する介入的デバイス。 - 前記介入的デバイスは、マイクロカテーテルデバイスである、請求項1に記載のデバイス。
- 前記マイクロカテーテルデバイスは、ポリエーテルエーテルケトンまたはニチノールから少なくとも部分的に形成されている、請求項2に記載のデバイス。
- 前記介入的デバイスは、ガイドワイヤである、請求項1に記載のデバイス。
- 前記ガイドワイヤは、コアを含み、前記細長い部材は、前記コアの遠位セクションが前記チューブ構造の少なくとも一部分中に入るように、前記コアに結合されたチューブ構造として形成されている、請求項4に記載のデバイス。
- 前記コアの遠位セクションの外面と前記チューブ構造の内面との間に設置されるように、前記チューブ構造内部に配設された1つまたは複数のコイルを更に備える、請求項5に記載のデバイス。
- 前記コアは、ステンレス鋼またはニチノールから形成されている、請求項5または請求項6に記載のデバイス。
- 前記チューブ構造は、ニチノールから形成されている、請求項5〜7のうちのいずれか1項に記載のデバイス。
- 前記穿孔は、1−ビーム、2−ビームカット、3−ビームまたは4以上−ビームパターンに配列されている、請求項1〜8のうちのいずれか1項に記載のデバイス。
- 前記細長い部材は、セグメントの連続から形成され、それぞれのセグメントは、第1の対の周方向に対向したビームと、前記第1の対のビームから約90度だけ回転方向にオフセットされている第2の対の周方向に対向したビームと、を含む、請求項9に記載のデバイス。
- 前記非らせんおよび非線形パターンは、分散パターンを含み、前記分散パターンは、0度位置に設置されるように画定された前記細長い部材の第1のビーム対を含み、連続ビーム対が、回転オフセット制限を上回ることなくビーム位置の放射方向分散を最大にするように前記第1のビーム対から回転方向にオフセットされ、前記回転オフセット制限は、あるセグメントから次のセグメントへの許容回転を制限する、請求項1〜10のうちのいずれか1項に記載のデバイス。
- 前記回転オフセット制限は、1つのビーム対から次のビーム対までの前記回転オフセットを約60から120度まで、約70から110度までまたは約80から100度までの値に限定する、請求項11に記載のデバイス。
- 連続ビーム対が、前記回転オフセット制限を上回ることなく最大の残りの位置的な間隙の中間点の近くに配置されている、請求項11または請求項12に記載のデバイス。
- 前記連続セグメントは、最大の残りの位置的な間隙の前記中間点に、前記回転オフセット制限が許容する限り近くに配置されている、請求項13に記載のデバイス。
- 前記分散パターンは、約1から30度までの位置的な粒状度を有する、請求項11〜14のうちのいずれか1項に記載のデバイス。
- 前記分散パターンは、0.1度から1度までの位置的な粒状度を有する、請求項11〜15のうちのいずれか1項に記載のデバイス。
- 前記回転オフセット制限は、30度よりも大きい、請求項11に記載のデバイス。
- 前記非らせんおよび非直線パターンの少なくとも一部分は、不完全ランプパターンを含む、請求項1〜17のうちのいずれか1項に記載のデバイス。
- 前記不完全ランプパターン内部の1組の3つの連続セグメントまたはビーム対は、同じ回転オフセットに従って間隔をおいていない、請求項18に記載のデバイス。
- 前記不完全ランプパターンは、1つのビーム対から次のビーム対までに不完全回転オフセットを含み、前記不完全回転オフセットは、一定値±可変修正値に等しい、請求項18または請求項19に記載のデバイス。
- 前記可変修正値は、5から15度までの範囲に及ぶ、請求項20に記載のデバイス。
- 前記不完全ランプパターンは、2−ビーム構成を有し、前記不完全回転オフセットの前記一定値部分は、約90度である、請求項20または請求項21に記載のデバイス。
- 前記非らせんおよび非直線パターンの少なくとも一部分は、のこぎり歯状パターンを含む、請求項1〜22のうちのいずれか1項に記載のデバイス。
- 前記のこぎり歯状パターンは、セクションが方向を逆にする前に前記細長い部材の周全体のまわりに重ならないように周期的に方向を逆にする回転オフセットを含む、請求項23に記載のデバイス。
- 前記のこぎり歯状パターンは、第1の頂点および第2の頂点を含み、前記のこぎり歯状パターンの回転オフセットは、前記第1または第2の頂点に到達すると方向を逆にする、請求項23または請求項24に記載のデバイス。
- 前記第1および第2の頂点は、約90度だけ分離されている、請求項25に記載のデバイス。
- 壁および内部管腔を有する細長い部材であって、前記壁を通って延び前記管腔を露出させる複数の穿孔を含み、前記複数の穿孔は、分散パターンに配列された、複数の軸方向に延びるビームおよび複数の周方向に延びるリングを画定する、細長い部材を備え、
前記分散パターンは、0度位置に配置されるように画定された前記細長い部材の第1のビーム対を含み、連続ビーム対が、回転オフセット制限を上回ることなくビーム位置の放射方向分散を最大化するように前記第1のビーム対から回転方向にオフセットされ、前記回転オフセット制限は、あるセグメントから次のセグメントへの許容回転を制限する介入的デバイス。 - 前記回転オフセット制限は、1つのビーム対から次のビーム対までの前記回転オフセットを約60から120度までの値、約70から110度までの値または約80から100度までの値に限定する、請求項27に記載のデバイス。
- 連続ビーム対が、最大の残りの位置的な間隙の中間点の、前記回転オフセット制限が許容する限り近くに配置されている等、前記回転オフセット制限を上回ることなく最大の残りの位置的な間隙の中間点の近くに配置されている、請求項27または請求項28に記載のデバイス。
- 前記分散パターンは、約1から30度までまたは約0.1度から1度までの位置的な粒状度を有する、請求項27〜29のうちのいずれか1項に記載のデバイス。
- 前記回転オフセット制限は、30度よりも大きい、請求項27〜30のうちのいずれか1項に記載のデバイス。
- 壁および内部管腔を有する細長い部材であって、前記壁を通って延び前記管腔を露出させる複数の穿孔を含み、前記複数の穿孔は、不完全ランプパターンに配列された、複数の軸方向に延びるビームおよび複数の周方向に延びるリングを画定する、細長い部材を備え、
前記不完全ランプパターン内の1組の3つの連続セグメントまたはビーム対が、同じ回転オフセットに従って間隔をあけていない介入的デバイス。 - 前記不完全ランプパターンは、1つのビーム対から次のビーム対までに不完全回転オフセットを含み、前記不完全回転オフセットは、一定値±可変修正値に等しい、請求項32に記載のデバイス。
- 前記可変修正値は、5から15度までの範囲に及ぶ、請求項33に記載のデバイス。
- 前記不完全ランプパターンは、2−ビーム構成を有し、前記不完全回転オフセットの前記一定値部分は、約90度である、請求項32〜34のうちのいずれか1項に記載のデバイス。
- 壁および内部管腔を有する細長い部材であって、前記壁を通って延び前記管腔を露出させる複数の穿孔を含み、前記複数の穿孔は、のこぎり歯状パターンに配列された、複数の軸方向に延びるビームおよび複数の周方向に延びるリングを画定する、細長い部材を備え、
前記のこぎり歯状パターンは、セクションが方向を逆にする前に前記細長い部材の周全体のまわりに重ならないように周期的に方向を逆にする回転オフセットを含む介入的デバイス。 - 前記のこぎり歯状パターンは、第1の頂点および第2の頂点を含み、前記のこぎり歯状パターンの回転オフセットは、前記第1または第2の頂点に到達すると方向を逆にする、請求項36に記載のデバイス。
- 前記第1と第2の頂点とは、約90度だけ分離されている、請求項37に記載のデバイス。
- 前記介入的デバイスは、マイクロカテーテルデバイスまたはガイドワイヤデバイスである、請求項27〜38のうちのいずれか1項に記載のデバイス。
- 前記介入的デバイスは、コアを含むガイドワイヤであり、前記細長い部材は、前記コアに結合されたチューブ構造として形成されることにより、前記コアの遠位セクションが前記チューブ構造の少なくとも一部分中に入る、請求項39に記載のデバイス。
- 前記コアの遠位セクションの外面と前記チューブ構造の内面との間に配置されるように前記チューブ構造内部に配設された1つまたは複数のコイルを更に備える、請求項40に記載のデバイス。
- 前記コアは、ステンレス鋼またはニチノールから形成されている、請求項40〜41のうちのいずれか1項に記載のデバイス。
- 前記チューブ構造は、ニチノールから形成されている、請求項40〜42のうちのいずれか1項に記載のデバイス。
- 前記穿孔は、1−ビーム、2−ビームカット、3−ビーム、または4以上−ビームパターンに配列されている、請求項27〜43のうちのいずれか1項に記載のデバイス。
- 前記細長い部材は、セグメントの連続から形成され、それぞれのセグメントは、第1の対の周方向に対向したビームと、前記第1の対のビームから約90度だけ回転方向にオフセットされている第2の対の周方向に対向したビームと、を含む、請求項44に記載のデバイス。
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US11369351B2 (en) | 2022-06-28 |
EP4257173A2 (en) | 2023-10-11 |
US12310567B2 (en) | 2025-05-27 |
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CN110691626B (zh) | 2022-03-18 |
ES2966345T3 (es) | 2024-04-22 |
US20220280147A1 (en) | 2022-09-08 |
KR102628519B1 (ko) | 2024-01-22 |
CN110691626A (zh) | 2020-01-14 |
EP3609563B1 (en) | 2021-03-24 |
EP3609563A1 (en) | 2020-02-19 |
EP4257173A3 (en) | 2023-11-29 |
AU2018273992B2 (en) | 2023-11-16 |
CA3063425A1 (en) | 2018-11-29 |
ES2869148T3 (es) | 2021-10-25 |
AU2018273992A1 (en) | 2019-12-19 |
AU2024201009A1 (en) | 2024-03-07 |
EP3842091B1 (en) | 2023-09-13 |
EP3842091A1 (en) | 2021-06-30 |
WO2018218216A1 (en) | 2018-11-29 |
KR20200011430A (ko) | 2020-02-03 |
JP2024023515A (ja) | 2024-02-21 |
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