JP2021522885A - 血管内部位から閉塞性物質を除去する装置および方法 - Google Patents
血管内部位から閉塞性物質を除去する装置および方法 Download PDFInfo
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Abstract
【選択図】図24−2
Description
本出願は、2018年5月1日に仮出願された米国仮出願第62/665,369号の利益を主張し、その出願の全体は参照により本明細書に組み込まれる。
Claims (61)
- 血管内部位から塞栓物質を除去するシステムであって、
近位端と、遠位端と、管状の側壁であって、その中を通って軸方向に延びる少なくとも1つの管腔を画定する管状の側壁とを有する、細長い可撓性の管状体と、
前記側壁によって支持され、前記管腔に露出している軸方向拘束装置と、
前記管腔を通って伸縮可能であり、近位端と遠位端とを有するコアワイヤと、
前記コアワイヤによって支持され、前記拘束装置と回転可能に係合する軸受け面を有する制限装置と、
前記コアワイヤの前記遠位端上の撹拌体先端部と、を含み、
前記制限装置と前記拘束装置が、前記コアワイヤの回転を許容するが、前記管状体に対して相対的に前記先端部の遠位前進を制限するように係合可能である、システム。 - 前記軸方向拘束装置が、近位に面した軸受け面を含む、請求項1に記載のシステム。
- 前記軸方向拘束装置が、半径方向内側に延びる突出部を含む、請求項2に記載のシステム。
- 前記軸方向の拘束装置が、環状フランジを含む、請求項3に記載のシステム。
- 前記制限装置が、遠位に面した軸受け面を含む、請求項1に記載のシステム。
- 前記制限装置が、半径方向外側に延びる突出部を含む、請求項5に記載のシステム。
- 前記半径方向外側に延びる突出部が、前記管状の側壁の内面と摺動接触するように構成される摺動体を支持するスポークを含む、請求項6に記載のシステム。
- 前記摺動体をそれぞれ支持する3本のスポークを含む、請求項7に記載のシステム。
- 前記制限装置が、環状リングを含む、請求項6に記載のシステム。
- 前記制限装置が、前記コアワイヤから半径方向外側に離間した環状リングを含む、請求項1に記載のシステム。
- 前記コアワイヤと前記リングとの間に延びる少なくとも2本のスポークをさらに含む、請求項10に記載のシステム。
- 前記コアワイヤと前記リングとの間に延びる3本のスポークを含む、請求項11に記載のシステム。
- スポークの各隣接する一対の間に、かつ前記中央管腔と連通して画定される流路を含む、請求項8に記載のシステム。
- 3つの流路を含み、前記3つの流路の断面積の合計が、前記拘束装置の近位1cmの範囲内の前記管腔の断面積の少なくとも約75%である、請求項13に記載のシステム。
- 前記3つの流路の断面積の合計が、前記拘束装置の近位1cmの範囲内の前記管腔の断面積の少なくとも約90%である、請求項14に記載のシステム。
- 前記コアワイヤが、前記近位点での大きい方の直径から前記制限装置での前記大きい方の直径の約30%以下の小さい方の直径までテーパ状になっている、請求項1に記載のシステム。
- 前記コアワイヤが、前記制限装置での前記大きい方の直径の約18%以下の小さい方の直径までテーパ状になっている、請求項16に記載のシステム。
- 前記コアワイヤが、前記近位点での約0.025インチの直径から前記制限装置での約0.005インチ以下の直径までテーパ状になっている、請求項17に記載のシステム。
- 前記攪拌体の先端部が、らせん状ねじ山を含む、請求項1に記載のシステム。
- 前記らせん状ねじ山が、前記管腔の内径の約90%以下のねじ外径を有して、前記先端部と前記側壁の内面との間に環状流路を残す、請求項19に記載のシステム。
- 前記コアワイヤによって支持され、かつ約5cmから約60cmまでの範囲内の長さで前記先端部から近位に延びるばねをさらに含む、請求項16に記載のシステム。
- 前記ばねが、約20cmから約40cmまでの範囲内の長さで前記先端部から近位に延びる、請求項21に記載のシステム。
- 前記らせん状ねじ山が、尖っていない外縁を有する、請求項19に記載のシステム。
- 前記制限装置が、前記カテーテル長の遠位約50%以下の範囲内に位置している、請求項1に記載のシステム。
- 前記制限装置が、前記カテーテル長の遠位約25%以下の範囲内に位置している、請求項24に記載のシステム。
- 前記コアワイヤが、前記管状体の内部に取り外し可能に位置決め可能である、請求項1に記載のシステム。
- 前記らせん状ねじ山が、軸方向に隣接するねじ山間のらせん状流路を画定し、前記らせん状流路の断面積と前記環状流路の断面積の和が、前記管腔の断面積の少なくとも約20%である、請求項20に記載のシステム。
- 前記軸受け面が、蛇行した血管系内部への前記管状体の位置決めに応答して、前記攪拌体先端部の、前記管状体を越えての遠位前進を切り離す、請求項25に記載のシステム。
- 機械的かつ吸引による支援を用いて血管から塞栓物質を除去する方法であって、
中央管腔および遠位端を有する吸引カテーテルを提供するステップと、
前記遠位端を血管内の閉塞性物質まで前進させるステップと、
前記管腔内部で先端部を回転させるステップであって、前記先端部が、約5mm以下の軸方向長さと、前記管腔の内径よりも少なくとも約0.015インチ小さい外径を有するらせん状ねじ山とを有し、前記先端部の外側の周囲に吸引流路を設けるステップと、
前記管腔に真空を印加し、前記先端部を回転させて物質を管腔内に引き寄せるステップと、
を含む、方法。 - 前記回転のステップが、前記カテーテル内を通じて延びるコアワイヤを手動で回転させ、前記先端部を回転させることを含む、請求項29に記載の方法。
- 前記中央管腔内に位置決めされた拘束装置に対して、前記コアワイヤによって支持される制限装置を回転させることによって、前記コアワイヤの遠位前進を制限するステップをさらに含む、請求項30に記載の方法。
- 遠隔部位から血管閉塞物を吸引する方法であって、
血管アクセス部位を通じて細長い管状体を血管閉塞物まで前進させるステップであって、前記管状体が、近位端と、遠位端と、中央管腔と、前記管状体から前記管腔内に延びる停止装置とを含むステップと、
回転可能なコアワイヤを、前記コアワイヤによって支持される制限装置が、前記停止装置に摺動可能に係合するまで、前記管腔内を通じて遠位方向に前進させて、前記管腔内部での前記コアワイヤのさらなる遠位前進を制限する回転可能な軸受けを提供するステップと、
前記管腔に真空を印加し、前記コアワイヤを回転させて血栓を前記管腔内に引き寄せるステップと、
を含む、遠隔部位から血管閉塞物を吸引する方法。 - 前記真空を印加するステップが、パルス性の真空を印加することを含む、請求項32に記載の血管閉塞物を吸引する方法。
- 前記細長い管状体を前進させるステップが、前記管状体のいかなる介在もなしにガイドワイヤにわたって直接達成される、請求項32に記載の血管閉塞物を吸引する方法。
- 前記管状体を、少なくとも内頸動脈の海綿質区分まで遠位に前進させることを含む、請求項32に記載の血管閉塞物を吸引する方法。
- 前記管状体を、少なくとも内頸動脈の脳区分まで遠位に前進させることを含む、請求項32に記載の血管閉塞物を吸引する方法。
- 前記回転可能なコアワイヤを前進させるステップが、細長い管状体を、血管アクセス部位を通じて血管閉塞物まで前進させるステップの後に達成される、請求項32に記載の血管閉塞物を吸引する方法。
- 前記回転可能なコアワイヤを前進させるステップが、前記細長い管状体を、血管アクセス部位内を通じて血管閉塞物まで前進させるステップと同時に達成される、請求項32に記載の血管閉塞物を吸引する方法。
- 非外傷性ナビゲーション用先端部を有する神経血管カテーテルであって、
近位端と、遠位端と、中央管腔を画定する側壁とを有する細長い可撓性の管状体を含み、前記管状体の遠位ゾーンが、
管状の内側ライナと、
前記内側ライナを取り囲み、遠位端を有するらせん状コイルと;
前記らせん状コイルを取り囲み、前記らせん状コイルの遠位端を越えて遠位に延びて、カテーテルの遠位面で終端する管状ジャケットと、
前記コイルの遠位端と前記遠位面との間で前記管状ジャケット内に埋め込まれた管状の放射線不透過性マーカと、を含み、
前記遠位面が、約35度から約55度までの範囲内の角度で前記管状体の長手方向軸を横切る平面上に存在し、
前記マーカが、前記長手方向軸に対してほぼ垂直な近位面と、約35度から約55度までの範囲内の角度で前記長手方向軸を横切る平面上に存在する遠位面とを有する、神経血管カテーテル。 - 前記遠位面が、前記管状体の後縁から遠位に延びる前記管状体の前縁を画定し、前記前縁および後縁が、長手方向軸の周りで互いから約180度離間している、請求項39に記載の神経血管カテーテル。
- 前記管状体の前進区分が、前記マーカ帯を越えて遠位に延びる、請求項40に記載の神経血管カテーテル。
- 前記前進区分が、前記管状体の前記前縁側の約1mmから約3mmまでの範囲内の軸方向長さを有する、請求項41に記載の神経血管カテーテル。
- 前記管状体の前記前縁側の前進区分の長さが、前記管状体の前記後縁側の前進区分の長さよりも大きい、請求項40に記載の神経血管カテーテル。
- 前記管状体の前記前縁側のマーカ帯の軸方向長さが、前記管状体の前記後縁側のマーカ帯の軸方向長さよりも少なくとも約20%長い、請求項40に記載の神経血管カテーテル。
- 前記管状体の前記前縁側のマーカ帯の軸方向長さが、約1mmから約5mmまでの範囲内である、請求項44に記載の神経血管カテーテル。
- 前記マーカ帯が、少なくとも1つの軸方向スリットを含む、請求項40に記載の神経血管カテーテル。
- 前記管状ライナが、取り外し可能なマンドレルを浸漬塗布することによって形成される、請求項40に記載の神経血管カテーテル。
- 前記管状ライナがPTFEを含む、請求項47に記載の神経血管カテーテル。
- 前記内側ライナと前記らせん状コイルとの間に結束層をさらに含む、請求項40に記載の神経血管カテーテル。
- 前記結束層が約0.005インチ以下の壁厚を有する、請求項49に記載の神経血管カテーテル。
- 前記結束層が、前記可撓体の少なくとも最遠位の20cmに沿って延びる、請求項50に記載の神経血管カテーテル。
- 前記コイルがニチノール(Nitinol)を含む、請求項40に記載の神経血管カテーテル。
- 前記ニチノールが、体温でオーステナイト(Austenite)状態を含む、請求項52に記載の神経血管カテーテル。
- 前記外側ジャケットが、軸方向に隣接する少なくとも5つの離散的な管状区分から形成される、請求項39に記載の神経血管カテーテル。
- 前記外側ジャケットが、軸方向に隣接する少なくとも9つの離散的な管状区分から形成される、請求項54に記載の神経血管カテーテル。
- 前記管状区分の近位のものと前記管状区分の遠位のものとの間のデュロメータの差が、少なくとも約20Dである、請求項54に記載の神経血管カテーテル。
- 前記管状区分の近位のものと前記管状区分の遠位のものとの間のデュロメータの差が、少なくとも約30Dである、請求項56に記載の神経血管カテーテル。
- 前記遠位ゾーンの張力抵抗を増加させる張力支持体をさらに含む、請求項40に記載の神経血管カテーテル。
- 前記張力支持体が、軸方向に延びるフィラメントを含む、請求項58に記載の可撓性を強化させた神経血管カテーテル。
- 前記軸方向に延びるフィラメントが、前記内側ライナと前記らせん状コイルとの間に支持される、請求項59に記載の神経血管カテーテル。
- 前記軸方向に延びるフィラメントが、前記管状体の引張強度を少なくとも約2ポンドまで増加させる、請求項59に記載の神経血管カテーテル。
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