JP2011520527A - 腹部大動脈瘤を治療するための装置及び方法 - Google Patents
腹部大動脈瘤を治療するための装置及び方法 Download PDFInfo
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- JP2011520527A JP2011520527A JP2011509771A JP2011509771A JP2011520527A JP 2011520527 A JP2011520527 A JP 2011520527A JP 2011509771 A JP2011509771 A JP 2011509771A JP 2011509771 A JP2011509771 A JP 2011509771A JP 2011520527 A JP2011520527 A JP 2011520527A
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Abstract
【選択図】図4B
Description
本出願は、2008年5月15日に出願された米国仮特許出願第61/053,378号に関するとともに該特許出願の利益を主張するものであり、該特許出願は、その全体が引用により本明細書に組み入れられて本明細書の一部を成す。
腹部大動脈瘤のEVAR(血管内動脈瘤修復)問題を治療するためのステントグラフトが、目立ちにくい導入、短い頸部、長下肢/短下肢のカテーテル法、グラフトのサイズ、グラフトの構成などの特徴を含むことができる。1つの好ましい実施形態では、ステントグラフトの要素が、(金属、ニチノール金属、形状記憶金属、プラスチック、形状記憶プラスチック又はその他の可撓性材料などの)レーザ切断した弾性材料又は半剛性材料のフラットシート、螺旋、又はメッシュからなる中間層、及び延伸PTFEオーバーラップからなる外層を含む少なくとも2つの層を含むことができる。ステントグラフトは、任意に伸縮性延伸PTFE(ポリテトラフルオロエチレン)管からなる第3の内層をさらに含む。これらの層は、ステントグラフト複合材料の構築材として機能するように圧縮される。ステントグラフトの遠位部(1ac)は、グラフトが腸骨動脈に適合するように成形することができる。ステントグラフトは、半円状の側面と平らな側面とを有するD型グラフト(Dグラフト)(図1A)のような異なる形状に成形することができる。1つの実施形態では、延伸PTFEが液体又は水を透過させない。内側PTFE層及び外側PTFE層が、複合構成材料の液体密封性を確実にする働きをする。
本発明の1つの態様は、拡張可能な可撓性シースに関する。1つの実施形態では、可撓性シースが、必要時に径方向に拡張できるように構成される。図3A〜図3Cは、外向きの力により径方向に拡張できる連続した一体型のシースを含む、軸方向の伸縮性/圧縮性が実質的にほとんど又は全く無い径方向拡張可能シースを示している。この拡張可能な可撓性シースは、軸方向の伸縮性を制限するように実質的に軸方向に配向した非伸縮性繊維又は糸を組み込んだ弾性ポリマーで作成することができる。1つの実施形態では、収縮状態(3aa)にある可撓性シースを、複雑な又は小径の血管内に通し、その後このシースを通じてより大きな装置(3ab)を挿入することができる。従って、この拡張可能なシースにより、大きなシースの前進が不可能な、通り抜けできない、非実用的な、又は解離を生じ得る複雑な又は小径の血管を通じて本発明のエンドグラフト又はDグラフトなどの大きな装置を配置できるようになる。大きな装置を配置した後、患者から拡張シース(3ac)を除去し、又は引き抜くことができる。1つの実施形態では、拡張可能な可撓性シースが径方向に伸縮自在である。拡張可能な可撓性シースは、「ガイドシース」として機能することができる。
短いネックのエンドグラフトを使用するための1つの実施形態では、腎動脈に腎ステントグラフトを埋め込むことができ、この腎ステントグラフトの金属メッシュ部分が、外部RFソースに電気的に接続されたRF電極(6ad)に取り外し可能に接続される。図6Aに示すように、腎ステントグラフト(6aa)の露出端部(6ab)が、大動脈内壁(6ac)を越えて延び又は突出する。図6Bは、大動脈内部に位置するエンドグラフト(6ae)を示しており、腎ステントグラフト(6aa)の露出端部がエンドグラフト外部と密接に接触してこれを圧迫している。ステント端部(6ab)にRF電流を印加することにより、(図6Cに示す)エンドグラフト繊維内に孔(6ah)を形成して、大動脈(6ag)と腎動脈(6af)の間に血液が通るようにする。エンドグラフトを腎動脈口の境界に密接かつ緊密に圧迫して血液の漏出又は浸出を防ぐ。
ここで図14を参照すると、本発明によるモジュール式二管腔エンドグラフトシステムの例示的な実施形態を、このようなシステムを体内に配置するため要素及び手順とともに示している。本発明のいくつかの態様は、大動脈及び左右腸骨動脈周辺の動脈壁にある腹部大動脈瘤を修復する方法に関し、この方法は、(a)左右大腿動脈の一方にガイドワイヤを経皮的に導入して、左右腸骨動脈のそれぞれ一方に進入させ、その後動脈瘤の領域を越えて大動脈の管腔に進入させるステップと、(b)ガイドワイヤ上に嵌合するようになっているガイドワイヤ管腔を内部に形成した第1の展開カテーテルの遠位端部分の周囲に崩壊状態のネック取り付け要素を組み立てるステップと、(c)ネック取り付け要素を腎動脈口近くの大動脈の部位に送達し、大動脈管腔の直径に近似した所定のサイズの取り付けシートを動脈瘤の領域を越えて施すステップと、(d)ネック取り付け要素を自己拡張又はバルーン拡張により展開して、この要素を返しなどで適所に定着又は固定させるステップと、(e)第1の展開カテーテルを回収するステップと、(f)遠位端と近位端の間に延びる連続する側壁を有し、いずれかの端部又は両端を金属メッシュ又はステント挿入要素で補強することができる第1の細長い管状グラフトプロテーゼを第2の展開カテーテルの遠位端部分の周囲に組み立てるステップと、(g)第1のグラフトプロテーゼを送達して、近位端がネック取り付け要素の周囲に、及び遠位端が右腸骨動脈の1つの周囲に位置するようにするステップと、(h)第1のグラフトプロテーゼの近位端を定着具によってネック取り付け要素上に展開する一方で、右腸骨動脈内に金属メッシュを展開するステップと、(i)第2の展開カテーテルを経皮的に回収するステップと、(j)第2の細長い管状プロテーゼ及び第3の展開カテーテルを使用してステップfからステップiまでを繰り返し、左腸骨動脈内に金属メッシュを展開させるステップとを含む。好ましい実施形態では、2つのグラフトプロテーゼの近位端の管腔開口部に隣接する円周領域をシールして、腹部動脈瘤内の2つのプロテーゼの外部に血液が流れ込むのを防ぐ。別の好ましい実施形態では、遠位端が、展開後にグラフト管腔及び腸骨動脈を動脈瘤部分からシールするような大きさ及び構成にされる。
(例えば、700、300、30ミクロンなどの)異なる気孔を含むPVAスポンジを、例えば7mmの管腔を有する25mmの「二重D」構成又は7mmの管腔を有する10mm長の管などの異なるサイズの管として作成することができる。乾燥状態のPVAスポンジは容易に圧縮され、完全に再水和して数分で元の状態に拡張することができる。本発明の1つの態様は、最適な気孔を含むPVAスポンジ管をエンドプラグとして圧縮乾燥形態で導入すること、及びこれが動脈瘤全体にわたって原位置で拡張できるようにすることである。次いで、管の貫通管腔を、拡張したスポンジの直径よりも小さな直径でステント挿入するか又はステント移植する。真空を印加すること、ラップすることによって多孔性スポンジプラグを圧縮し又はファネルに注入することができる。乾燥スポンジプラグをステント又はバルーン上に圧接し、シースを通じてワイヤ上に押し付け、或いは独自の送達装置に予め取り付けることができる。
動脈瘤嚢の排除はステントグラフト治療の主な目標であり、動脈瘤の「全排除」により臨床的成果が定義される。しかしながら、時には、動脈瘤嚢への血流を全て排除するためのステントグラフトに障害が起こることがある。実際のところ、内部漏出が合併症の、従ってAAAの管腔内治療における障害の主要な原因となる。内部漏出とは、装置配置後に動脈瘤嚢に持続的に流れる血液が存在することを表す用語である。いくつかの種類の内部漏出の管理についてはまだ議論の余地があるが、ほとんどは、手術、さらなるステント移植、又は塞栓でうまく閉塞させることができる。これらの提案される病因に基づいて4つの種類の内部漏出が定義されてきた。
本発明のいくつかの態様は、カテーテル室内で局所麻酔を使用して経皮的送達(好ましくは12フレンチ以下の小型送達カテーテル)を行うという臨床的ニーズを満たす改良したモジュール式AAA装置に関する。モジュール式装置は複数のサイズを有することができるが、特注ではない。装置は、とりわけネック取り付け、ねじれ及び腸骨生体構造に対して解剖学的に完全に適合できるように構成される。最新の装置は、大動脈に沿って同じ軸方向立面にない短頸及び/又は2つの腎動脈を有する患者に移植を行うのに特に適している。図7は、大動脈に沿って同じ軸方向立面にない2つの腎動脈の問題を解決するためのいくつかの手順及び手段を示している。図9は、短頸の問題を解決するためのいくつかの手順及び手段を示している。
第1のカフを(図30Aに示すような)腎動脈よりも下の大動脈領域内に導入してここを占有した後、第1のカフにバルーンカテーテルを導入してバルーン膨張させる(ステップ1)。カフ管腔内でマイクロカテーテル又はその他の適当な手段を使用して流体でカフを膨張させる(ステップ2)。次に、第1のカフ領域に第2の管腔にカテーテルを挿入する(ステップ3)。血管造影図を使用して位置及びシールをチェックし、必要であれば再位置決めする(ステップ4)。図30Bは、第2のカフを小径方式で腸骨動脈に挿入するステップ(ステップ5)を示している。液体ポリマーでカフを満たし、熱、UV、溶剤溶解、化学反応又は沈降反応を使用して液体ポリマーを硬化させる(ステップ6)。次に、図30Cに示すようなステントグラフトを挿入する(ステップ7)。代替の実施形態では、(図30Dに示すような)一致する又はD型のカフを有する2カフグラフトを適用することができる。
図31は、金属又は剛性支持要素(「バルーンエンドグラフト」)を使用せずに二重層可膨張性バルーンで作成したエンドグラフトの1つの実施形態を示している。バルーンエンドグラフト(31aa)は、流体、生理食塩水又は硬化性軟質ポリマーで膨張できる空間を間に有する二重層で作られる。1つの実施形態では、エンドグラフト(31aa)が、ネック取り付け部材(31ab)と、管状本体(31ac)と、分岐遠位端(31ad、31ae)とを含み、ネック取り付け部材は、上側ネック取り付けリングユニット(31ba)と、下側ネック取り付けリングユニット(31bb)と、流体連通のためのスループット管腔を備えた、上側ネック取り付けリングユニットと下側ネック取り付けリングユニットとを接続する少なくとも2つの接続ユニット(31bc)とを含むことができる。1つの好ましい実施形態では、上側ネック取り付けリングユニット(31ba)が、近位腎動脈(31ca)と遠位腎動脈(31cb)との間に配置されるように構成されるのに対し、下側ネック取り付けリングユニット(31bb)は、遠位腎動脈(31cb)の遠位に配置されるように構成される。別の好ましい実施形態では、接続ユニット(31bc)の数を3又はそれ以上として、実質的に互いに平行な2つのネック取り付けリングユニットを保持するようにする。1つの実施形態では、片方又は両方の遠位端に任意の導入ポートが設けられ、この導入ポートは自己密封式であり、或いは空間に流体を注ぎ込んで可膨張性エンドグラフトを膨張させるための一方向弁を有する。
4ab エンドグラフト
4ac 血管
Claims (33)
- カフと少なくとも2つのエンドグラフトユニットとを含む大動脈瘤(AAA)治療用エンドグラフトシステムであって、個々のエングラフトユニットが、管腔と、近位端と、遠位端とを有し、前記エンドグラフトユニットが、前記カフに配置され固定された近位端と腸骨動脈の各々に配置され固定される前記遠位端とを有する可撓性の防水性管で作成される、ことを特徴とするエンドグラフトシステム。
- 前記エンドグラフトユニットが、圧縮可能な防水性発泡管で作成される、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 前記システムが、4つのエンドグラフトユニットを含み、個々のエンドグラフトユニットが、管腔と、近位端と、遠位端とを有し、4つの近位端が全て前記カフに配置され固定されるのに対し、第1の遠位端が延びて右腸骨動脈に固定されるようになり、第2の遠位端が延びて左腸骨動脈に固定されるようになり、第3の遠位端が延びて右腎動脈に固定されるようになり、第4の遠位端が延びて左腎動脈に固定されるようになる、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 前記カフが、前記エンドグラフトユニットを適所に保持する突起を有する、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 前記カフが発泡体カフを含む、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 前記発泡体が、硬化性発泡材料で作成される、ことを特徴とする請求項5に記載のエンドグラフトシステム。
- 前記発泡材料が、ポリビニルアルコール発泡体、ポリ(エチレン−コ−ビニルアルコール)、セルロースアセテート、ポリ(2−ヒドロキシエチルメタクリレート)、アクリレート、及びこれらの組み合わせからなる群から選択される、ことを特徴とする請求項6に記載のエンドグラフトシステム。
- 前記発泡材料が、UV光又は熱で処理される、ことを特徴とする請求項6に記載のエンドグラフトシステム。
- 第1のエンドグラフトユニットの前記第1の近位端が、第2のエンドグラフトユニットの第2の近位端に実質的に近い距離に位置する、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 前記エンドグラフトユニットが、防水性可撓管からなる内層と、半剛性メッシュ状材料からなる中間層と、防水性の可撓性オーバーラップからなる外層とを含み、前記エンドグラフトユニットが少なくとも2つの防水層を含む、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 前記内層が伸縮性PTFE管で作成され、前記外層が伸縮性PTFEオーバーラップで作成される、ことを特徴とする請求項10に記載のエンドグラフトシステム。
- 前記エンドグラフトユニットが、マイクロファイバー織布で作成される、ことを特徴とする請求項1に記載のエンドグラフトシステム。
- 腹部大動脈瘤(AAA)治療用エンドグラフトであって、ネック取り付け部分と、グラフト体と、脚部とを含み、前記ネック取り付け部分が、腎動脈の近位に配置されるための少なくとも第1の定着要素と、該第1の定着要素から軸方向に離間して配置された、前記腎動脈の遠位に配置されるように構成された第2の定着要素とを含む複数の定着機構を有する、ことを特徴とするエンドグラフト。
- 複数の定着機構が、2つの腎動脈間の領域の周囲に配置されるように構成された第3の定着要素を含む、ことを特徴とする請求項13に記載のエンドグラフト。
- AAA治療用エンドグラフトであって、ネック取り付け部分と、近位端と第1の腸骨動脈内部に固定されるべく前記ネック取り付け部分から前記第1の腸骨動脈へ延びる長さとを有する第1の発泡管と、近位端と第2の腸骨動脈内部に固定されるべく前記ネック取り付け部分から前記第2の腸骨動脈へ延びる長さとを有する第2の発泡管とを含み、両発泡管が前記ネック取り付け部分に固定される、ことを特徴とするエンドグラフト。
- 第1の発泡管の前記第1の近位端が、第2の発泡管の前記第2の近位端に実質的に近い距離に位置する、ことを特徴とする請求項15に記載のエンドグラフト。
- 前記ネック取り付け要素がハンガーを含み、前記第1の発泡管の前記近位端がフックで構成されて前記フックを前記ハンガーに確実に連結する、ことを特徴とする請求項15に記載のエンドグラフト。
- 前記第1の発泡管の遠位端を広げ、該遠位端を前記第1の腸骨動脈の周辺組織に定着させてシールする、ことを特徴とする請求項15に記載のエンドグラフト。
- 前記発泡管の近位部分を可膨張性要素で作成し、前記近位部分が膨張して前記近位部を血管壁に定着させて固定する、ことを特徴とする請求項15に記載のエンドグラフト。
- 前記発泡管の少なくとも1つが、可膨張性管体をさらに含む、ことを特徴とする請求項15に記載のエンドグラフト。
- 前記発泡管の少なくとも1つが、径方向の位置決め構造を使用しないように十分なフープ強度を有する可撓性グラフトとして機能する、成形充填材料で満たされた二重壁バッフル管体を含む、ことを特徴とする請求項15に記載のエンドグラフト。
- 前記発泡管の少なくとも一端の前記バッフル層の一部を裏返してカフを形成する、ことを特徴とする請求項21に記載のエンドグラフト。
- 血管に挿入するための可撓性ステントグラフトであって、遠位部と、近位部と、該遠位部及び近位部を接続する管腔とを有するグラフト体を含み、前記グラフトが、可撓性の剛性又は半剛性材料からなる第1の層と、防水性の可撓性オーバーラップからなる第2の層とを有し、前記グラフトが折り畳み式であり、挿入手術中に目立たない、ことを特徴とするステントグラフト。
- 前記第1の層が、前記挿入手術中にシース内で圧縮可能な螺旋状ワイヤを含む、ことを特徴とする請求項23に記載のステントグラフト。
- 前記第1の層を適所に位置決めした後に、前記第2の層が前記第1の層上に重積する、ことを特徴とする請求項23に記載のステントグラフト。
- 防水性の可撓管からなる第3の層をさらに含み、前記グラフトが少なくとも2つの防水層を含む、ことを特徴とする請求項23に記載のステントグラフト。
- 前記ステントグラフトの端部にあるスリーブが、前記第1及び第2の層上に前記第3の層の余長を反転させることにより形成される、ことを特徴とする請求項23に記載のステントグラフト。
- 前記第3の層が可撓性繊維又はポリマー管で作成され、前記第2の層が可撓性繊維又はポリマーオーバーラップで作成される、ことを特徴とする請求項23に記載のステントグラフト。
- 前記グラフトの前記近位部分の周囲に、前記グラフトを血管壁に定着させるように構成された定着具が二次手術として設けられる、ことを特徴とする請求項23に記載のステントグラフト。
- 請求項4に記載の第1及び第2のステントグラフトを含むステントグラフトシステムであって、いずれかのステントグラフトの近位部分が、半円状側面及び結合側面を有するように成形され、前記2つのグラフトの前記近位部分が互いに結合して円筒状管状構成を形成する際に、前記第1のステントグラフトの前記第1の結合側面が、前記第2のステントグラフトの前記第2の結合側面に結合して密接に一致する、ことを特徴とするステントグラフトシステム。
- 前記第1のステントグラフトの前記第1の結合側面が、正電荷磁石を有するように構成され、前記第2のステントグラフトの前記対向する第2の結合側面が、負電荷磁石を有するように構成されて、結合時に制御シール及び密接な接触を確実にするようにされる、ことを特徴とする請求項30に記載のステントグラフトシステム。
- 大動脈瘤(AAA)治療用エンドグラフトであって、前記エンドグラフトの管腔と周辺動脈瘤嚢との間の血液連通を排除するための不透過性部分と、腎動脈口を横切って配置されるように構成された多孔性部分と、を含むことを特徴とするエンドグラフト。
- 前記エンドグラフトが、前記不透過性部分よりも長いマクロ多孔性スリーブを含み、前記多孔性部分が、前記不透過性部分の少なくとも一部の上に前記マクロ多孔性スリーブを固定することにより作成される、ことを特徴とする請求項32に記載のエンドグラフト。
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- 2009-05-15 CN CN201510037534.6A patent/CN104905891A/zh active Pending
- 2009-05-15 CA CA 2724771 patent/CA2724771A1/en not_active Abandoned
- 2009-05-15 EP EP09747719.4A patent/EP2285308A4/en not_active Withdrawn
- 2009-05-15 JP JP2011509771A patent/JP5676431B2/ja active Active
- 2009-05-15 CN CN2009801268217A patent/CN102088927A/zh active Pending
- 2009-05-15 AU AU2009246093A patent/AU2009246093A1/en not_active Abandoned
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JP2013533017A (ja) * | 2010-06-25 | 2013-08-22 | サンブセッティ,アントニオ | 同所性人工膀胱装具 |
Also Published As
Publication number | Publication date |
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WO2009140638A1 (en) | 2009-11-19 |
US20150265394A1 (en) | 2015-09-24 |
CA2724771A1 (en) | 2009-11-19 |
AU2009246093A1 (en) | 2009-11-19 |
US20090287145A1 (en) | 2009-11-19 |
EP2285308A1 (en) | 2011-02-23 |
JP5676431B2 (ja) | 2015-02-25 |
JP2015057243A (ja) | 2015-03-26 |
CN104905891A (zh) | 2015-09-16 |
EP2285308A4 (en) | 2015-06-03 |
CN102088927A (zh) | 2011-06-08 |
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