JP2021501647A - 内蔵フィルタを有する塞栓術用カテーテル - Google Patents
内蔵フィルタを有する塞栓術用カテーテル Download PDFInfo
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- JP2021501647A JP2021501647A JP2020524460A JP2020524460A JP2021501647A JP 2021501647 A JP2021501647 A JP 2021501647A JP 2020524460 A JP2020524460 A JP 2020524460A JP 2020524460 A JP2020524460 A JP 2020524460A JP 2021501647 A JP2021501647 A JP 2021501647A
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- Prior art keywords
- microcatheter
- section
- slits
- distal end
- embolization
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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Abstract
【選択図】図1
Description
本明細書で開示するマイクロカテーテルを使用した蛍光ビーズの用量送達を、標準的マイクロカテーテルの用量送達と比較した。本明細書で開示するマイクロカテーテルは、本明細書に開示するように形成され、編組を用いた骨格と離間された5つの円周方向の区間を用いた流体バリアを含み、各区間は6つの軸方向のスリットを含み、円周方向の各区間はその隣接する区間から約0.3mm離間され、同じ円周方向の区間の中のスリットは、同じ区間内のその隣接するスリットから約0.5mm離間され、複数の軸方向のスリットの各々は約0.35mmの長さと30〜50マイクロメートル(マイクロカテーテルの内径で測定)の幅を有する。
本明細書で開示するように形成された本明細書で開示するマイクロカテーテルの注入量を標準的カテーテルのそれと比較した。
本明細書で開示されているように形成され、ここで5つの離間された円周方向の区間を用いた編組骨格による流体バリアを有し、各区間は6つの軸方向のスリットを含み、円周方向の各区間はその隣接する区間から約0.3mm離間され、同じ円周方向の区間の中のスリットは、同じ区間内のその隣接するスリットから約0.5mm離間され、複数の軸方向のスリットの各々は約0.35mmの長さと30〜50マイクロメートル(マイクロカテーテルの内径で測定)の幅を有する本開示のマイクロカテーテルを、ISO10555−1による引張試験のために試験した。試験サンプルは、より小さい区間に切断しマイクロカテーテルアセンブリ内の各接合部を試験できるようにした。区間を試験前に37℃の水槽中に入れ、1つずつ取り出して試験を行い、熱の損失をできるだけ最小限にした。
マイクロカテーテルのキンク半径とは、それがキンクを生じずに曲がることのできる最小半径と定義される。本発明の実施形態による各種のマイクロカテーテルのキンク半径を特定するために、異なる半径を有するピンで固定具を作った。マイクロカテーテルを、最も大きいものから始めて、各ピンの周囲に慎重にループ状にかけ、近位及び遠位端部が相互に180度になるようにした。次に、両端を反対方向に引っ張り、マイクロカテーテルがピンの周囲で締まるようにする。マイクロカテーテルを各ピンの上でキンクが発生するまで試験する。マイクロカテーテルを、キンクを生じさせずに巻き付けることのできた最も小さいピンを記録する。その結果、標準的なマイクロカテーテルを使用した時のキンク半径は1.5mmであり、有利な点として、本明細書で開示するマイクロカテーテルを使用した場合のキンク半径は0.9mmであったことを示した。
Claims (21)
- 標的区域に塞栓粒子を送達するための塞栓術用マイクロカテーテルにおいて、
前記マイクロカテーテルの近位端部にあり、前記マイクロカテーテルを標的位置に送達するように構成された第一の区間と、
前記マイクロカテーテルの遠位端部にあり、そこを通る流れを制限するように構成された第二の区間であって、前記マイクロカテーテルを通る懸濁液の送達を可能にするような大きさと形状である遠位端開口を含み、前記懸濁液は懸濁溶媒と前記塞栓粒子を含む、第二の区間と、
前記第一の区間と前記第二の区間との間にある第三の区間であって、
前記遠位端開口の近位側に、そこから所定の距離だけ離れて形成された複数の軸方向のスリットであって、前記複数の軸方向のスリットの各々は前記塞栓粒子のそこからの流出を防止しながら、前記懸濁溶媒の流出を可能にするように構成された最小の断面寸法を有し、前記複数のスリットは、前記フィルタ区間の下流の前記粒子が、前記懸濁液中の基本的にすべての粒子が前記遠位端開口から送達され、その一方でその逆流を防止するような体積流量で流れるような大きさ及び形状である、複数の軸方向のスリットを含む第三の区間と、
を含み、
前記第三の区間は、前記第一の区間より高い柔軟性を有する材料で形成され、前記塞栓術用マイクロカテーテルは少なくとも約5Nの引張強度を有する塞栓術用マイクロカテーテル。 - 骨格は編組みワイヤで形成され、ポリマ層は前記骨格の中に挿入され、及び/又はその上に重ねられ、前記骨格の前記編組みワイヤと前記ポリマ層はカットされ、それによって基本的に前記骨格及び/又はポリマ層を含まない前記複数の軸方向のスリットが形成される、請求項1の塞栓術用マイクロカテーテル。
- 前記複数の軸方向のスリットの各々は、その外面において、その内面スリットと比較してより大きい幅を有し、それによって前記塞栓粒子が前記マイクロカテーテルの内部から前記複数の軸方向のスリットに入ることが防止され、その一方で、そこを通る前記懸濁溶媒の流出をほとんど制限しない、請求項1又は2のマイクロカテーテル。
- 前記第三の区間は、前記マイクロカテーテルの前記外面の上に重ねられる親水性コーティングをさらに含み、前記複数の軸方向のスリットは、前記親水性コーティングを貫通して形成される、請求項1〜3の何れか1項のマイクロカテーテル。
- 前記第三の区間は、前記マイクロカテーテルの前記内面を裏打ちする内層をさらに含み、前記複数の軸方向のスリットは前記内層を貫通して形成される、請求項1〜4の何れか1項のマイクロカテーテル。
- 前記内側コーティングはポリテトラフルオロエチレン(PTFE)を含む、請求項5のマイクロカテーテル。
- 前記複数の軸方向のスリットの各々の前記幅は約15〜100マイクロメートルの範囲である、請求項1〜6の何れか1項のマイクロカテーテル。
- 前記複数の軸方向のスリットの各々の前記幅は約50マイクロメートルである、請求項7のマイクロカテーテル。
- 前記第一の区間の曲げ剛さは約0.003〜0.01lbs−in^2である、請求項1〜8の何れか1項のマイクロカテーテル。
- 前記第三の区間の曲げ剛さは約0.0001〜約0.002lbs−in^2である、請求項1〜9の何れか1項のマイクロカテーテル。
- 前記第二の区間はテーパ状の内面を有する、請求項1〜10の何れか1項のマイクロカテーテル。
- 前記第二の区間は非テーパ状の内面を有する、請求項1〜10の何れか1項のマイクロカテーテル。
- 前記第二の区間の内筒径は約0.2〜0.75mmの範囲である、請求項1〜12の何れか1項のマイクロカテーテル。
- 前記第三の区間の前記複数のスリットの総開口面積は約0.2〜1mm2の範囲である、請求項1〜13の何れか1項のマイクロカテーテル。
- 前記第三の区間の前記複数のスリットの総開口面積は約0.2〜0.6mm2の範囲である、請求項1〜13の何れか1項のマイクロカテーテル。
- 前記第三の区間の少なくとも5〜30%は前記複数のスリットにより形成された開口面積である、請求項1〜13の何れか1項のマイクロカテーテル。
- 前記ポリマ層の極限引張強度は9000〜10000psiであり、極限伸びは350〜450%である、請求項1〜16の何れか1項のマイクロカテーテル。
- 前記ポリマ層の極限引張強度は約9600psiであり、極限伸びはほぼ400%である、請求項17のマイクロカテーテル。
- 前記ポリマ層はポリカーボネート系熱可塑性ポリウレタンである、請求項1〜18の何れか1項のマイクロカテーテル。
- 前記複数の軸方向のスリットは、前記編組みワイヤのレーザカットにより形成される、請求項1〜19の何れか1項のマイクロカテーテル。
- 標的区域に塞栓粒子を送達するための塞栓術用マイクロカテーテルにおいて、
前記マイクロカテーテルの近位端部にあり、標的位置に前記マイクロカテーテルを送達するように構成された第一の区間と、
前記マイクロカテーテルの遠位端部にあり、それを通る流れを制限するように構成された第二の区間であって、前記マイクロカテーテルを通じて流れる懸濁液の送達を可能にする大きさ及び形状の遠位端開口を含み、前記懸濁液は懸濁溶媒と前記塞栓粒子を含む、第二の区間と、
前記第一の区間と前記第二の区間との間に配置された第三の区間であって、
編組み又はコイルワイヤで形成される骨格と、
前記骨格の中に挿入された、及び/又はその外側に重ねられたポリマ層と、
前記遠位端開口の近位側に、そこから所定の距離だけ離れて形成された複数の軸方向のスリットと、を含み、前記軸方向のスリットの各々は、ポリマ層を選択的に横断し、その一方で、前記骨格は無傷のまま残され、前記複数の軸方向のスリットの各々は、その外面において、その内面スリットと比較してより大きい幅を有し、それによって前記塞栓粒子が前記マイクロカテーテルの内筒から前記複数の軸方向のスリットに入るのを防止し、その一方で、前記複数の軸方向のスリットを通じた前記懸濁溶媒の流出をほとんど制限しない、第三の区間と、
を含む塞栓術用マイクロカテーテル。
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- 2018-11-01 JP JP2020524460A patent/JP7364193B2/ja active Active
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JPH09508557A (ja) * | 1994-08-08 | 1997-09-02 | シュナイダー(ユーエスエー)インク | 迅速交換構成の薬剤搬送用カテーテルおよび膨張型薬剤搬送用カテーテル |
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Also Published As
Publication number | Publication date |
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WO2019087191A1 (en) | 2019-05-09 |
EP3703583A4 (en) | 2020-12-30 |
BR112020008852A2 (pt) | 2020-10-20 |
JP7364193B2 (ja) | 2023-10-18 |
US20210177430A1 (en) | 2021-06-17 |
EP3703583A1 (en) | 2020-09-09 |
US11653929B2 (en) | 2023-05-23 |
KR20200085285A (ko) | 2020-07-14 |
IL274383B2 (en) | 2024-03-01 |
IL274383B1 (en) | 2023-11-01 |
CN111447882A (zh) | 2020-07-24 |
IL274383A (en) | 2020-06-30 |
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