JP2017525519A - 経頸動脈アクセスのための方法およびデバイス - Google Patents
経頸動脈アクセスのための方法およびデバイス Download PDFInfo
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Abstract
Description
この出願は、2014年9月4日に出願された「経頸動脈(transcarotid)アクセスのための方法およびデバイス」と表題が付けられた米国仮出願番号62/046,112号および2014年11月4日に出願された「経頸動脈アクセスのための方法およびデバイス」と表題が付けられた米国仮出願番号62/075,169号の優先権の利益を主張する、「経頸動脈アクセスのための方法およびデバイス」と表題が付けられ2014年11月10日に出願された米国特許出願番号14/537,316号の継続出願である、「経頸動脈アクセスのための方法およびデバイス」と表題が付けられ2014年12月18日に出願された米国特許出願番号14/575,199号の優先権を主張する。前述の出願日の優先権を主張し、それらの特許出願の全体が、参照によって本明細書に取り込まれる。
いくつかの例では、所望のアクセス部位は、頸動脈である。例えば、頸動脈分岐部および内頸動脈の疾患を処置するための手技は、このアクセス部位にかなり近い。頭蓋内および脳の動脈における手技は、同様に、大腿動脈よりもこのアクセス部位に、はるかに近い(closure)。この動脈も、上に示した代替のアクセス動脈のいくつかよりも大きい。(総頸動脈は、典型的に、直径が6〜10mmであり、橈骨動脈は、直径が2〜3mmである。)
図2を再び参照すると、経頸動脈用動脈アクセスシース220の1つの実施形態は、細長いシース本体222と、アクセスシース220の細長いシース本体222の近位端にある近位アダプタ224とを含む。細長いシース本体222は動脈アクセスシース220の一部分であり、動脈の中に挿入されるように寸法が決められて成形されており、細長いシース本体の少なくとも一部分は、手技中に動脈の中に実際に挿入される近位アダプタ224は、止血弁226と、シース本体222の内部管腔と連通する内部管腔を有する細長い噴出ライン228とを含む。近位アダプタ224は、シース本体222よりも大きい直径または断面の寸法を有していてもよい。止血弁226はシース本体222の内部管腔と連通しており、手技中に、内部管腔を介した血液損失を回避または最小限にしつつ、その中にデバイスを導入することを可能にしている。1つの実施形態では、止血弁226は、静的シール(static seal)タイプパッシブ弁である。(図5に示された)動脈アクセスシース220の代替の実施形態では、止血弁226は、ツイボースト(Tuohy−Borst)弁227または回転止血弁(RHV)などの調整可能な開口弁である。代わりに、アクセスシース220は、パッシブシール弁、ツイボースト(Tuohy−Borst)弁、または回転止血弁(RHV)のいずれかの独立した止血弁の構成要素を取り付けることができる、メスのルア(Luer)アダプタの近位端で終端してもよい。
脈、または大動脈弓、大動脈弁、冠動脈、または他の末梢動脈であってもよい。これらのターゲット位置に対して、細長いシース本体222の適切な長さは、ターゲット位置からアクセス部位までの距離に依存する。この構成では、細長いシース本体222は、動脈アクセス部位を通して置かれ、大動脈に向かって下方に方向付けられる。
図2を再び参照すると、シース拡張器260は、経頸動脈アクセスシースシステム200の構成要素である。シース拡張器260は、動脈の中に挿入される細長い本体であり、動脈壁の穿刺部位を通して、シースガイドワイヤ300の上へのアクセスシース220の滑らかな挿入を可能にする。したがって、拡張器260の遠位端は、拡張器を動脈中のシースガイドワイヤ300上に挿入することができるように、そしてニードル穿刺部位を、アクセスシース220そのものの挿入のために大きい直径に拡張させるために、一般に、テーパ状である。これらの機能に適合するために、拡張器260は、(拡張器の長手方向軸線に対する)全体的な角度(または全体を含む角度:total included angle)が概ね6〜12度のテーパを有し、丸い先端(leading edge)を備えたテーパ端部268を有する。シース拡張器は、動脈の中への挿入のために組み立てられたとき、典型的に、アクセスシースに固定される。例えば、シース拡張器260の近位ハブ264は、動脈アクセスシース220の止血弁226の対応する構造の中または上方に嵌めこまれるように構成されている。拡張器260の内部管腔は、例えば、シースガイドワイヤサイズに応じて、0.037〜0.041”の内側直径を有するシースガイドワイヤ300に適合する。
動脈アクセスシースは、典型的に、0.035”または0.038”直径のシースガイドワイヤ上で、動脈中に導入される。拡張器の遠位先端の内側直径およびテーパ長さは、このようなガイドワイヤと一致するように寸法が決められる。例えば、橈骨動脈アクセスのためのいくつかのシースは、遠位先端の内側直径およびテーパ長さを有する対応する拡張器とともに、0.018”直径のシースガイドワイヤに適合するように寸法が決められる。シースガイドワイヤは、傷つけない直線状の、角度が付いた、またはJ先端を有していてもよい。ガイドワイヤは、近位端の固いセグメントに滑らかに移行する。この構造は、シースが動脈中のワイヤ上に導入されたときにシースのための支持を可能にしつつ、動脈の中へのワイヤの傷つけない侵入および前進を可能にする。典型的には、傷つけない先端からの移行は、固い部分に対して、約4〜9cmである。シースが挿入されたときに、ワイヤの固いセグメントが動脈の侵入部位に存在するように、シースは、通常、動脈の中に15〜20cm挿入される。
図1を参照すると、初期経頸動脈アクセスのためのマイクロアクセスキット100は、アクセスニードル120、アクセスガイドワイヤ140、およびマイクロアクセスカニューレ160を含む。マイクロアクセスカニューレ160は、本体162と、本体162の管腔の内部でスライド可能に配置された内側拡張器168とを含む。典型的には、動脈アクセスのために、改良されたセルジンガー技術が使用される場合、初期ニードル穿刺は、21Gまたは22Gアクセスニードル、または18Gニードルにより行われてもよい。経頸動脈アクセスでは、さらに小さいニードル穿刺によってアクセスすることが望ましい。頸動脈の経皮的アクセスは、典型的に、大腿動脈のものよりも困難である。頸動脈は、厚い壁の動脈であり、頸動脈シースとして知られた組織スリーブに囲まれており、それは、筋肉組織を取り囲むのと同様に固定されておらず、それゆえに、初期ニードル刺し(initial needle stick)は難しく、不安定な動脈に、より大きな力で刺さなければならず、したがって、誤った部位への穿刺、動脈の切断、または後壁穿刺のリスクが増加する。小さい初期ニードル穿刺、例えば、23Gまたは24Gニードルは、ニードル侵入の容易性を増加させ、これらのリスクを減少させる。シースガイドワイヤは、小さいニードル、例えば、0.016”または0.014”ワイヤに適合するように適切に寸法が決められるべきである。アクセスニードル120は、超音波ガイドによる動脈中へのニードル挿入を支援するために、超音波でそれを見ることができる状態にするように、遠位端にテクスチャー加工した表面を含んでもよい。ニードル長さは、長さ4cm〜8cmの範囲にあってもよい。
上で説明されたデバイスのいずれかまたは全ては、システムの1つ以上の構成要素が一般的なパッケージまたはパッケージの集合に含まれるように、ユーザにキットの形で提供されてもよい。アクセスシースキットの1つの実施形態は、上で説明されたような経頸動脈アクセスのために構成されたアクセスシース、シース拡張器、およびシースガイドワイヤの全てを備える。
ここに、経頸動脈アクセスシステムのための例示の使用方法を記載する。頸動脈狭窄を処置するための例示の経頸動脈手技では、ユーザが、総頸動脈に至るまで切断を実行することによって開始する。その後、ユーザは、所望のアクセス部位でアクセスニードル120を総頸動脈の中に挿入する。経頸動脈アクセスのために構成されたテーパを有するアクセスガイドワイヤ140は、ニードルを通して総頸動脈の中に挿入され、CCAの中に前進される。アクセスニードル120は抜去され、マイクロアクセスカニューレ160は、CCA中のワイヤ140上に挿入される。マイクロアクセスカニューレは、ガイドとして、カニューレのマーク166を使用して所望の深さに挿入され、過挿入を回避する。
Claims (22)
- 介入デバイスを頸動脈中に導入するためのデバイスのシステムであって、
カテーテルを動脈中に導入するように適合された動脈アクセスシースであって、前記動脈アクセスシースは、頸動脈アクセス部位を介して総頸動脈中に導入するように寸法が決められて成形されたシース本体を含み、前記シース本体は、前記総頸動脈内に配置されたときに前記カテーテルを前記総頸動脈中に導入するための通路を提供する内部管腔を画定する、動脈アクセスシースと、
前記シース本体の前記内部管腔の内部に配置可能な細長い第1拡張器であって、前記第1拡張器は、動脈中への前記動脈アクセスシースの挿入のためにニードル穿刺部位をより大きい直径に拡張させるように寸法が決められて成形されたテーパ状の遠位先端を有し、前記第1拡張器は、動脈中のシースガイドワイヤ上に該拡張器を挿入できるようにするための前記内部管腔を有し、前記第1拡張器の少なくとも一部分が第1曲げ剛性を有し、前記動脈アクセスシースおよび前記第1拡張器を前記総頸動脈中に共に導入できる、細長い第1拡張器と、
前記シース本体の前記内部管腔の内部に配置可能な細長い第2拡張器であって、テーパ状の遠位先端を有し、動脈中の前記ガイドワイヤ上に前記第2拡張器を挿入できるようにするための内部管腔を有し、前記第1拡張器の前記第1曲げ剛性よりも少ない第2曲げ剛性を有する遠位領域を有する、細長い前記第2拡張器と
を含むシステム。 - 前記第1拡張器は、動脈中への急峻な挿入角度に適合するように、前記第1拡張器の近位部分よりも柔軟な遠位部分を有する、請求項1に記載のシステム。
- 前記第1拡張器の遠位部分は、長さが2〜5cmである、請求項2に記載のシステム。
- 前記第1拡張器の遠位部分は、前記第1拡張器の近位部分よりも20%〜50%柔軟である、請求項2に記載のシステム。
- 前記第2拡張器の遠位領域は、前記第1拡張器の遠位部分よりも柔軟である、請求項1に記載のシステム。
- 前記第2拡張器の遠位領域は、長さが2〜5cmである、請求項1に記載のシステム。
- 前記第2拡張器の遠位領域は、前記第2拡張器の近位領域よりも20%〜50%柔軟である、請求項1に記載のシステム。
- 前記第2拡張器は、前記第2拡張器の近位領域と前記第2拡張器の遠位領域との間における剛性の滑らかな移行を提供する中央の中間部分を有する、請求項1に記載のシステム。
- 前記第1拡張器の遠位領域は、50〜100N−mm2の範囲の曲げ剛性を有し、前記第2拡張器の遠位領域は、5〜15N−mm2の範囲の曲げ剛性を有する、請求項1に記載のシステム。
- 前記第1および第2拡張器の少なくとも1つに放射線不透過性先端マーカーをさらに含む、請求項1に記載のシステム。
- 前記第2拡張器の前記内部管腔は、前記第1拡張器の前記内部管腔の直径よりも小さい直径を有する、請求項1に記載のシステム。
- 前記第1拡張器の前記内部管腔は、直径が0.035〜0.038インチのガイドワイヤに適合し、前記第2拡張器の前記内部管腔は、直径が0.014〜0.018インチのガイドワイヤに適合する、請求項1に記載のシステム。
- 前記第1拡張器および前記第2拡張器の少なくとも1つの近位領域は、それぞれの拡張器の前記内部管腔中への前記ガイドワイヤの挿入または前記内部管腔からの抜去を許容するために、それぞれの拡張器の前記内部管腔へのアクセスを提供する側部開口を有するハブを含む、請求項1に記載のシステム。
- 前記ハブは、前記側部開口をカバーする前記第1位置と前記側部開口をカバーしない前記第2位置との間を移動するスリーブを含む、請求項13に記載のシステム。
- 前記第2拡張器は、外側拡張器と、共軸配置で前記外側拡張器にスライド可能に取り付ける1つ以上の内側拡張器とから形成された二部式拡張器である、請求項1に記載のシステム。
- 前記外側拡張器は、直径が0.035〜0.038インチのガイドワイヤに適合し、前記内側拡張器は、直径が0.014〜0.018インチのガイドワイヤに適合する、請求項15に記載のシステム。
- 前記内側拡張器および前記外側拡張器は、前記内側拡張器および前記外側拡張器を互いに固定するために、互いを固定する近位ハブを含む、請求項15に記載のシステム。
- 前記内側拡張器の少なくとも1つは、それぞれの拡張器の長手方向軸線から離れるように角度付けられた角度付き先端を有する、請求項15に記載のシステム。
- 前記シース本体は、近位部分と、前記近位部分よりも柔軟である最遠位部分とを有し、前記シース本体の全長に対する前記最遠位部分の全長の比率は、前記シース本体の全長の1/10〜1/2である、請求項1に記載のシステム。
- 前記シース本体は、近位部分と、前記近位部分よりも柔軟である最遠位部分とを有し、前記最遠位部分は、長さが2.5〜5cmであり、全体の前記シース本体は、長さが20〜30cmである、請求項1に記載のシステム。
- 前記シース本体は、近位部分と、前記近位部分よりも柔軟である最遠位部分と、柔軟な前記最遠位部分と前記近位部分との間の移行部分とを有し、前記最遠位部分は、長さが2.5〜5cmであり、前記移行部分は、長さが2〜10cmであり、全体の前記シース本体は、長さが20〜30cmである、請求項1に記載のシステム。
- 前記第1および第2拡張器の少なくとも1つは、前記動脈アクセスシースの前記内部管腔に配置されたときに前記動脈アクセスシースに固定されるように構成されている、請求項1に記載のシステム。
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US9126018B1 (en) | 2015-09-08 |
CN112545591A (zh) | 2021-03-26 |
JP6682510B2 (ja) | 2020-04-15 |
CN106714889A (zh) | 2017-05-24 |
JP2020114421A (ja) | 2020-07-30 |
JP6995914B2 (ja) | 2022-01-17 |
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EP4062963A1 (en) | 2022-09-28 |
EP4062963B1 (en) | 2024-04-24 |
US11759613B2 (en) | 2023-09-19 |
EP3738641B1 (en) | 2022-03-30 |
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