JP2005511242A - 積層状構造のステントグラフトとその製造方法 - Google Patents
積層状構造のステントグラフトとその製造方法 Download PDFInfo
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Abstract
Description
多孔性外層12はステントグラフト10の最も外側の層である。多孔性外層12は一般に円筒型でよい。多孔性外層12は適切な生体親和性材料、実際には生体吸収性(すなわち、生体分解性)か生体内安定性(すなわち、非生体分解性)のどちらかで作ることができる。使用できる材料の代表的な例には制限はないが、多孔性ポリウレタン(例えば、Thoralon(登録商標)、カリフォルニア州プレザントンのThoratecコーポレイションより入手可能)、ePTFE、PET、alphiticポリオキサエステル、ポリラクチド、ポリカプロラクトン、及びヒドロゲルを含む高分子材料が挙げられる。“ヒドロゲル”は共有結合、イオン結合、あるいは水素結合を通じて架橋ポリマーを含有し、ゲルを作るために水分子を取り込むことができる3次元開口格子構造を形成するよう意図される。ヒドロゲルの例としてはアニオンヒドロゲル(例えば、アルギン酸ゲルあるいはカラジーナン)や“固体”ヒドロゲル(例えば、アガロースあるいはポリエチレン酸化物)のような非許容ゲルが挙げられる。
無孔中層14は多孔性外層12と多孔性内腔層16に付着していてもよい。図5はステント18が配置されている均一のポリマー層を提供するためにステント18を内包している無孔中層14を示している。従って、無孔中層14はポリマー層と支柱20の表面の間に支柱20の周囲にある隙間やくぼみがないように構成されることが可能である。
多孔性内腔層16はステントグラフト10の最も内部の半径層になりうる。多孔性内腔層16は無孔中層14に接することができる。多孔性内腔層16は適当な多孔生体親和性材料、現実に生体吸収性(すなわち生体分解性)あるいは生体安定性(例えば非生体分解性)を有するものから作られている。適切な材料の例は多孔性外層12と同じであるべきである。多孔性外層12と同様に、多孔性内腔層16は異なった孔隙で作られた副層に設計されている。
図1と2に示されたように、ステント18は無孔中層14に完全に囲まれていることが可能である。ステント18は一般に円形の横断面か、楕円形、六角形もしくは八角形のような他の機能的な形状を有することができる。図8A、8B、そして8Cについて説明すると、ステント18は複数の相互接続した(図8A、そして8Bで示すように)、あるいは分離された(図8Cで示すように)支柱20から作られている。接合部は、支柱20の間、もしくは支柱20の先端部の間に生じることが可能である。接合部は機械的なひだ、溶接部、もしくははんだ部であってもよい。ステント18は金属のシリンダーから機械加工されるかエッチング処理を施されていてもよい。
(締め付け、および折りたたみ)
図12A〜12Cは、デリバリーに備えてステントグラフト10を折りたたむ方法の実施形態を示している。図12Aは通常の、あるいは弛緩した状態でのステントグラフト10の実施形態を示している。図12Bにおいて、矢印で示すようにステントグラフト10の2つのほぼ反対の側面から半径方向に圧迫することにより、ステントグラフト10に力を加えることができる。この力はステントグラフト10において圧迫を引き起こす。圧迫はステントグラフト10のほぼ全長に沿って縦方向に広がることが可能である。ステントグラフト10は圧迫のどちらか一方の側面上で丸い突出部52と54を形成することができる。突出部52と54はステントグラフト10のほぼ全長に沿って広がることが可能である。
図12Fはデリバリー用のステントグラフト10を準備するための半径方向の圧縮性の実施形態を示している。半径方向の拡張性ステントグラフト10はバルーン拡張性もしくは自己拡張性である。ある実施形態では、半径方向の拡張性ステントグラフト10は、矢印で示すようにステントグラフト10上に2つかそれ以上の内部への半径方向の力を加えることにより圧縮される。ステント18の半径方向の圧縮性構造、すなわち当業者に知られているいくつかの実施形態のために、ステントグラフト10はより小さな直径に崩壊する。
全ての組成物は、全ての成分が組み合わされその後調整される従来の方法により準備されることが可能である。例えば、ポリマーの所定の量もしくはポリマーの組み合わせは、溶媒中あるいは溶媒混合物中で溶解され、例えば、周囲圧力で無水条件下である。もし必要ならば、かき混ぜることによる穏やかな加熱や攪拌は、ポリマーを効果的に溶解させるために用いてもよい。溶媒は所望の濃度でポリマーを溶液中に溶かすことができる流体として定義される。
不活性な(例えば、ガラス)主軸はステントグラフト10の製造を促進することができる。一実施形態では、主軸は直径6mm(0.24インチ)であり、製造する前にイソプロピルアルコールを用いて消毒される。主軸は多孔性内腔層16を形成するために第1の組成物に浸されるか、あるいは代わりに主軸は第1の組成物に噴き付けられてもよい。
多孔性内腔層16の形成に続いて、第2の組成物は、噴霧するか主軸を浸すことによる無孔中層14の蒸着のために多孔内腔層16に塗布されることが可能である。第2の組成物は、第2の溶媒で混ぜられた無孔中層14用の前述のポリマーの少なくとも1つを構成することができる。第2の溶媒は第1の溶媒と同じかあるいは異なっていてもよい。第2の溶媒は内腔層16を湿らせ中層14で付着することを手助けしている。第2の組成物用のポリマーの溶媒に対する可能な比率は、第1の組成物用の比率と同じであってもよい。主軸が第2の組成物中に浸される場合の一実施形態では、第2の組成物は重量で約24%のポリマーである。
無孔中層14の形成に続いて、第3の組成物が多孔性外層12の形成のために無孔中層14に塗布される。第3の組成物は、第3の溶媒で混合された多孔性外層12用の前述のポリマーのうちの少なくとも1つから構成されている。第3の溶媒は、第1もしくは第2の溶媒と同じかあるいは異なっていてもよい。第3の溶媒は、中層14を湿らせることで外層12への接着を手助けすることができる。第3の組成物用のポリマーの溶媒に対する可能な比率は、第1の組成物用の比率と同じであってもよい。主軸が第3の組成物に浸される場合の一実施形態では、第3の組成物は重量で約10%のポリマーである。
除去が可能な溶媒中で混合されたコーティングの化学物質で噴霧するか浸すことにより、ステントグラフト10を内腔側面もしくは外層側面上で覆うこともできる。潤滑油はシリコン、ポリビニルpryoladone、そしてポリプロピレンオキシド(PPO)、さらにその他の当業者に知られた生体親和性潤滑油を含有するコーティング剤に内包することができる。薬物はコーティング剤として内包されていてもよいし、あるいは外層12や16に埋め込まれていてもよい。薬物は溶解でき、溶媒やポリマー組成物、あるいは微粒子中に懸濁したものの中で飽和状態かあるいは過飽和状態になっていてもよい。代わりに薬物は外層12や内腔層16の孔隙中に物理的に内包されていてもよい。
本発明は、図を通して与えられ本発明の目的を過度に制限しようとするものではない以下の例を参照することでより良く理解されるであろう。それぞれの例において、ステントグラフトの実施形態は異なった特徴の試験がなされた。例で用いられているステントグラフトは、約110ミクロンの厚さの多孔性内腔層、約135ミクロンの厚さの無孔中層、そして約205ミクロンの厚さの多孔外層で覆われたSymphony(登録商標)ニチノールステントであり、それら全てはThoralon(登録商標)から作られている。
3つのステントグラフトはヒトの動脈(例えば、5〜7%の半径方向の伸展性)に類似した半径方向の伸展性を持った模擬の動脈の内腔に取り付けられ、促進耐久性試験を受けた。耐久性試験は37℃の水で満たされたEnduraTEC試験システム(ミネソタ州ミンネトンカのEnduraTECシステムズコーポレイションより入手可能)において行われた。圧力は最低80mmHgから最高120mmHg、56時間に40Hzの速さで循環された。これは1分間に心拍数72回で77日に相当する。耐久性運転完了時にそれぞれのステントグラフトは、被覆剤、ステント突出、被覆剤の剥離、ステント不具合もしくは何か他の明白な装置の不具合における裂傷が視覚的に40倍の倍率で検査された。試験完了時、どのステントグラフトにも不具合は認められなかった。
デリバリーシステムやステントグラフトを適切に配置する能力を評価する試験が10F鞘付き誘導針(フロリダ州マイアミのCordisコーポレイションより入手可能)を有する流量閉回路において、5%から7%の半径方向の伸展性を持った模擬動脈で行われた。Thoratec(登録商標)14086補助人工心臓(VAD)は1分間に心拍数72回標的血管を通じて1分間に180と220mlの間で模擬動脈を通して流速を与えた。3つのステントグラフトは分離デリバリーシステムに装着されて35分間、120℃で蒸気滅菌された。
配置試験に続いて、同じシステムにおいて各ステントグラフトの位置が血管の外から印をつけられ、3日間流し続けた。もしどんな動きでも記録されたら、試験は失敗とみなされる。試験の終わりに、それぞれの装置の位置が視覚的な検査により確認され、移動がないことが明らかになった。
MIO試験は、Thoralon(登録商標)がニチノールの存在下で分解されるかどうかを決定するために行われた。MIO試験はネガティブ(理論的にはダメージなし)コントロールやポジティブ(理論的には厳しいダメージ)コントロールの両者を試験の試料(Thoralon(登録商標)の中層中に内包されたニチノールステントであるが、外もしくは内層にはない)と共に用いた。試料は37℃で長時間3%の過酸化水素の溶液に浸した。分解は外観検査や分子量分析を通して評価された。もし分解が生じたならば、試料の分子量は減少しポリマーの応力亀裂が形成されるであろう。試料は2週間毎に取り外され試験された。15週間の試験によりポジティブコントロールの分解が示され、一方で試験のステントグラフトやネガティブコントロールには分解の形跡は確認されなかった。
3つのステントグラフトについて、30日間3つのステントを備えた3匹の羊の頚動脈で試験を行った。拡張血管を維持して血栓形成を防ぎ、脈管内膜の内成長を促進させ、そして構造的に無傷のままにするためのステントグラフトの効果は他の特徴に共通してこれらの生体実験によって示される。表1は動物実験をまとめている。
Claims (21)
- 血管壁の組織に接するための多孔性第1層と、
前記多孔性第1層に付着した無孔層と、
前記無孔層によって内包されたフレームと、
多孔性第2層とを有し、前記無孔層は前記多孔性第1層と前記多孔性第2層の間に存在するステントグラフト。 - 前記多孔性第1層は空隙容量の割合が約40%から約90%である請求項1に記載のステントグラフト。
- 前記多孔性第1層は空隙容量の割合が約70%から約80%である請求項1に記載のステントグラフト。
- 前記無孔層は空隙容量の割合が5%未満である請求項1に記載のステントグラフト。
- 前記無孔層は空隙容量の割合が1%未満である請求項1に記載のステントグラフト。
- 前記多孔性第2層は空隙容量の割合が約40%から約90%である請求項1に記載のステントグラフト。
- 前記多孔性第2層は空隙容量の割合が約65%から約80%である請求項1に記載のステントグラフト。
- 前記多孔性第1および第2層の孔隙は約1ミクロンから約400ミクロンの平均孔直径を有する請求項1に記載のステントグラフト。
- 前記フレームは隙間で隔てられた複数の相互に接続された支柱を有する請求項1に記載のステントグラフト。
- 前記フレームは相互に離れて隔てられた複数のリングを含む請求項1に記載のステントグラフト。
- 前記多孔性第1あるいは第2層は複数の副層を有し、各副層は異なった多孔率を有する請求項1に記載のステントグラフト。
- (a)主軸に多孔性第1層を形成すること、
(b)前記多孔性第1層に第2層を形成すること、
(c)前記第2層にフレームを配置すること、
(d)前記第2層の厚さを増加させて実質的に、あるいは完全に第2層の中でフレームを覆うこと、
(e)第2層上の多孔性第3層を形成することを有するステントグラフトの製造方法。 - 前記多孔性第1層を形成する工程は、溶媒と、前記溶媒中に溶かしたポリマーと、それらに加えられた水溶性粒子とを含む組成物を主軸表面に塗布すること、前記溶媒と前記水溶性粒子を前記ポリマーから除去することを有する請求項12に記載の方法。
- 前記第3層を形成する工程は、溶媒と、前記溶媒中に溶かしたポリマーと、それらに加えられた水溶性粒子とを含む組成物を第2層に塗布すること、前記溶媒と前記水溶性粒子を前記ポリマーから除去することを有する請求項12に記載の方法。
- 前記多孔性第1および第3層は空隙容量の割合が約40%から約90%である請求項12に記載の方法。
- 前記第2層は空隙容量の割合が約5%未満である請求項12に記載の方法。
- 前記フレームは複数の相互に接続された支柱を有する請求項12に記載の方法。
- 前記フレームは相互に離れて隔てられた複数のリングを有する請求項12に記載の方法。
- 前記第2層はフレームの表面に接触しているエリアの周囲に隔てられた領域を含まない請求項12に記載の方法。
- 前記(a)と(b)の工程は、
(a)第1のポリマーと第1の溶媒を含む第1の組成物を主軸へ塗布して、前記第1の溶媒の大部分を前記組成物から除去して前記第1のポリマーの表面を半固体状態にして第1のポリマーを主軸に固めることと、
(b)第2のポリマーと第2の溶媒を含む第2の組成物を前記第1のポリマーへ塗布して、第1および第2の溶媒を除去して、第1層と第1層に接した前記第2層を形成することを有する請求項12に記載の方法。 - 前記(b)から前記(e)までの工程は、
(a)第1のポリマーと第1の溶媒を含む第1の組成物を第1層に塗布し、ほぼ全ての第1の溶媒を前記組成物から除去して第1ポリマーを固めることと、
(b)第2層にフレームを配置することと、
(c)第1の組成物を第2層とフレームに再度塗布して、第1の溶媒を組成物から除去して第2層の厚みを増加させることと、
(d)もし必要ならば、足場構造が実質的に、あるいは完全に第2層によって覆われるまで工程(c)を繰り返すことと、
(e)第2のポリマーや第2の溶媒を含む第2の組成物を第2層に塗布して第3層を形成することを有する請求項12に記載の方法。
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PCT/US2002/038940 WO2003051233A1 (en) | 2001-12-14 | 2002-12-06 | Layered stent-graft and methods of making the same |
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Publication number | Publication date |
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AU2002353068A1 (en) | 2003-06-30 |
EP1460972B1 (en) | 2015-06-17 |
CA2469744C (en) | 2010-04-13 |
WO2003051233A1 (en) | 2003-06-26 |
AU2002353068B2 (en) | 2008-06-05 |
EP1460972A4 (en) | 2008-05-21 |
JP4411431B2 (ja) | 2010-02-10 |
US6752826B2 (en) | 2004-06-22 |
CA2469744A1 (en) | 2003-06-26 |
EP1460972A1 (en) | 2004-09-29 |
US20030114917A1 (en) | 2003-06-19 |
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