JP5676431B2 - 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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- JP5676431B2 JP5676431B2 JP2011509771A JP2011509771A JP5676431B2 JP 5676431 B2 JP5676431 B2 JP 5676431B2 JP 2011509771 A JP2011509771 A JP 2011509771A JP 2011509771 A JP2011509771 A JP 2011509771A JP 5676431 B2 JP5676431 B2 JP 5676431B2
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Landscapes
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- Biomedical Technology (AREA)
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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 (11)
- 患者の大動脈瘤(AAA)治療用モジュール式エンドグラフトシステムであって、
第1の螺旋状ワイヤを有する第1の層と、前記第1の層に結合され、流体について実質的に不透過性の第1の可撓性の織物オーバーラップ層を備えた第1のエンドグラフトと、
第2の螺旋状ワイヤを有する第2の層と、前記第2の層に結合され、流体について実質的に不透過性の第2の可撓性の織物オーバーラップ層を備えた第2のエンドグラフトと、を備え、
前記第1及び第2のエンドグラフトは各々更に、湾曲側と平らな側のあるD型断面を有する近位部分と、実質的に円形の断面を有する遠位部分と、前記近位部分と前記遠位部分を接続し、前記D型断面から前記実質的に円形の断面へと移行する断面を有する本体部分を備え、
前記第1及び第2のエンドグラフトの近位部分は、前記患者の大動脈内に配置され、前記第1のエンドグラフトの近位部分の平らな側と前記第2のエンドグラフトの近位部分の平らな側が結合し、前記第1のエンドグラフトの近位部分の湾曲側及び前記第2のエンドグラフトの近位部分の湾曲側が大動脈壁と密接に接してシールするように構成されている、
ことを特徴とするモジュール式エンドグラフトシステム。 - 前記第1及び第2のエンドグラフトの各々の近位部分が更に、径方向外向きに展開するように構成された返しを備える、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2のエンドグラフトの各々の前記返しが、前記エンドグラフトが進行方向に移動できるようにし、前記エンドグラフトが前記進行方向に対して逆方向に移動すると前記大動脈に係合するように構成されている、ことを特徴とする請求項2に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2のエンドグラフトの各々の前記返しが、形状記憶材料で作成されている、ことを特徴とする請求項2に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2の螺旋状ワイヤが形状記憶材料を含む、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
- 前記第1のオーバーラップ層は、前記第1の層の外側に配置され、前記第2のオーバーラップ層は、前記第2の層の外側に配置される、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2のオーバーラップ層は伸縮性である、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2のオーバーラップ層は伸縮性延伸PTFE製である、ことを特徴とする請求項7に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2のオーバーラップ層はポリエステル繊維製である、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
- 前記第1のエンドグラフトの前記遠位部分は、前記患者の第1の腸骨動脈内に配置及び固定されるように構成され、前記第2のエンドグラフトの前記遠位部分は、前記患者の第2の腸骨動脈内に配置及び固定されるように構成されている、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
- 前記第1及び第2のエンドグラフトのうち少なくとも1つは、前記患者の腎動脈に血流を送り込むことができるよう、開口部を備えている、ことを特徴とする請求項1に記載のモジュール式エンドグラフトシステム。
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WO2009140638A1 (en) | 2009-11-19 |
AU2009246093A1 (en) | 2009-11-19 |
CN102088927A (zh) | 2011-06-08 |
EP2285308A1 (en) | 2011-02-23 |
EP2285308A4 (en) | 2015-06-03 |
US20090287145A1 (en) | 2009-11-19 |
CA2724771A1 (en) | 2009-11-19 |
US20150265394A1 (en) | 2015-09-24 |
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