JP2006500173A - 高強度の真空堆積されたニチノール合金フィルム、医療用薄膜グラフト材料、およびそれを作製する方法。 - Google Patents
高強度の真空堆積されたニチノール合金フィルム、医療用薄膜グラフト材料、およびそれを作製する方法。 Download PDFInfo
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Abstract
Description
平坦な正方形片(1×1cm)として、ステントを作製するのに用いられる金属および金属合金の5個の試料を準備した:電解研磨した316Lステンレス鋼、2つの異なる表面処理(電解研磨および電解研磨/熱処理)がなされたニチノール、金、タンタルおよびチタン。全ての試料片は、以下のような標準化された5工程の超音波洗浄プロセスを受けた:順に、洗剤(20%のExtran 1000(VWR Science, West Chester, P.C.))中の初期浴、引き続いて蒸留水すすぎ、メタノールすすぎ、アセトンすすぎ、および蒸留水すすぎ。
316Lステンレス鋼、電解研磨(ep)ニチノール、電解研磨および熱処理された(epht)ニチノール、金、タンタルおよびチタンの全表面エネルギーは、epニチノールの32.8ダイン/cmから316Lステンレス鋼の64.6ダイン/cmまでの範囲におよび、その平均は43.94.8ダイン/cmであった。試験されたそれぞれの金属の全表面エネルギーを図2に示した。それぞれの金属に関する全表面エネルギーの極性成分および分散性(すなわち非極性)成分を図3に示し、非極性成分が0.210.07の平均極性/非極性比を有して最大であった。
電解研磨316Lステンレス鋼、2つの異なる表面処理(電解研磨および電解研磨/熱処理)がなされたニチノール、金、タンタルおよびチタンの平坦な1×1cmの正方形片(厚さ0.159cm)を相対的な金属表面の静電力の測定に用いた。全ての試料片は、以下のような標準化された5工程の超音波洗浄プロセスを受けた:順に、洗剤(20%のExtran 1000(VWR Science, West Chester, P.C.))中の初期浴、引き続いて蒸留水すすぎ、メタノールすすぎ、アセトンすすぎ、および蒸留水すすぎ。洗浄後、希薄食塩水(pH7.0)下における静電力曲線の取得のために、金属試料をAFM中に配置した。それぞれの金属試料の5つの部位において10回の静電力曲線を実施した。それぞれ異なる金属を有する5種の試料の総計を測定した。
力−体積画像の色レベルの試験において、ニチノールの画像に比較して、金およびステンレス鋼の体積画像の色が比較的均質であることが注目された。加えて、金およびステンレス鋼は、記載されるより暗い(すなわち、より低い)測定値における平均化後のニチノール画像について得られるレベルよりも平均的に高い、同等の静電力レベルを有するように見える。図5は、金属試料上の定量的測定値を示すグラフであり、一方、図6aは力−体積画像を反映したグラフであり、および図6bは、それぞれの画像に関する個々の力曲線である。
第1の群160aおよび第3の群160cは共通の縦軸を有し、一方、第2の群160bおよび第4の群160dは、共に第1の群160aおよび第3の群160cの縦軸に垂直である共通の縦軸を有するようなものであることによって特徴づけられる。この様式において、微孔性金属薄膜被覆は、概して市松模様の開口部の群を有し、および径方向および縦軸方向の拡張可能性を示す。
a. HCマグネトロン中に取り付けられるが、カソードとターゲットとの間に薄いセラミック製円筒を配置することによって、水冷カソードとターゲットとの間の熱接触が阻害されるような、ニチノールターゲットを準備する;
b. カソードとターゲットとの間の電気的接触を提供する;
c. 基材は、100μmローパスフィルタを用いた500μm長さの軌跡に関するRa<50nmの表面粗さである表面仕上げまでその外側を研磨された、無酸素(OFE)銅管である;
d. 基材を真空チャンバ内に配置し、引き続いて該真空チャンバを、およそ2×10−7トール未満のベース圧力まで排気する;
e. 基材を、約400〜500℃の間の温度まで予熱する。あるいはまた、基材予熱工程を排除し、非予熱の基材表面への堆積が起こることも同様に考慮する;
f. 純Arガス(99.99%以上の純度)を、約1ミリトールと20ミリトールとの間の圧力において、堆積チャンバへと導入する;
g. ターゲット調整:マグネトロンに電力を供給してプラズマを発生させ、ダミーの基材とともに約10〜40分にわたって使用して、安定な堆積条件を実現する。約50mm直径および約150mmの長さのターゲットサイズに関して、マグネトロン電力はおよそ0.1kWと1kWとの間である。カソードの電圧は、約400Vと1000Vとの間、好ましくは600〜900Vの間に維持され、そして一定に保持される。Arガス供給を調節して、Arガス圧力を調整して、一定のカソード電圧を維持する;
h. 基材を、全ての面においてほぼ等しい約10mm〜25mmの照射距離を与えるスパッタ位置に移動させる;
i. 基材を、約10rpmと200rpmとの間の回転速度でその縦軸周りで回転させる;
j. 基材に対して、約−60Vと−100Vとの間の負のバイアス電圧を与える;
k. 所望される厚さの堆積物を与える期間にわたって、スパッタを実施する;
l. 堆積の完了後、プラズマを消失させ、そして、堆積チャンバ中に冷Ar(アルコールおよびドライアイスの混合物冷媒中に浸漬されるコイルを用いて冷却される)を導入することによって、真空下で堆積物を急冷する。
Claims (68)
- (a) 擬弾性特性を有する金属材料を含む微孔性金属薄膜被覆と、
(b) 金属材料を含み、および少なくとも一対の円筒形要素と、隣接する円筒形要素を接合する連結部材とをさらに含むる、該微孔性金属薄膜被覆の下にある構造支持体要素と
を含み、
(c)該微孔性金属薄膜被覆と該構造支持体要素との間の少なくとも1つの接触点によって、該構造支持体要素が該微孔性金属薄膜被覆に接着されている
ことを特徴とする移植可能な管腔内グラフト。 - 前記少なくとも1つの接触点は、該微孔性金属薄膜被覆の近位端または遠位端のいずれか、および該構造支持体要素の対応する端の近傍に位置することを特徴とする請求項1に記載の移植可能な管腔内グラフト。
- 前記少なくとも1つの接触点は、該微孔性金属薄膜被覆および該構造支持体要素の遠位端の近傍に位置することを特徴とする請求項1に記載の移植可能な管腔内グラフト。
- 前記構造支持体要素は、該構造支持体要素の末端から縦軸方向に伸びる少なくとも1つの延長部材をさらに含むことを特徴とする請求項1に記載の移植可能な管腔内グラフト。
- 前記少なくとも1つの延長部材は、該微孔性金属薄膜被覆に接着されていることを特徴とする請求項4に記載の移植可能な管腔内グラフト。
- 前記円筒形要素は、交互の峰部および谷部を有する正弦曲線パターンを採ることを特徴とする請求項1に記載の移植可能な管腔内グラフト。
- 前記連結部材は、峰部−峰部または谷部−谷部のいずれかで、隣接する円筒形要素を接合することを特徴とする請求項6に記載の移植可能な管腔内グラフト。
- 前記円筒形要素は、交互の峰部および谷部を有する正弦曲線パターンをとり、および前記少なくとも1つの延長部材は、該構造支持体要素の末端の少なくとも1つの谷部から縦軸方向に伸びることを特徴とする請求項4に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜被覆は、該微孔性金属薄膜被覆の表面全体を通して均一なパターンの開口部を示すことを特徴とする請求項8に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜被覆および前記構造支持体要素は、ニチノールから製造されることを特徴とする請求項9に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜被覆は、室温から体温への温度変化を通してマルテンサイト結晶構造を維持し、および生体内でマルテンサイト的に挙動することを特徴とする請求項10に記載の移植可能な管腔内グラフト。
- 室温から体温への温度変化中にマルテンサイト結晶構造からオーステナイト結晶構造への相転移を起こし、および生体内でオーステナイト的に挙動する構造支持体要素をさらに含むことを特徴とする請求項10に記載の移植可能な管腔内グラフト。
- 室温から体温への温度変化を通してオーステナイト結晶構造を維持し、および生体内でオーステナイト的に挙動する微孔性金属薄膜被覆をさらに含むことを特徴とする請求項10に記載の移植可能な管腔内グラフト。
- 室温から体温への温度変化中にマルテンサイト結晶構造からオーステナイト結晶構造への相転移を起こし、および生体内でオーステナイト的に挙動する微孔性金属薄膜被覆をさらに含むことを特徴とする請求項10に記載の移植可能な管腔内グラフト。
- 前記少なくとも1つの接触点は、末端において円筒形要素から近位端方向または遠位方向に突出する突出部をさらに含み、および該円筒形要素の谷部および連結部材と共に4点結合を形成することを特徴とする請求項1に記載の移植可能な管腔内グラフト。
- 前記円筒形要素の幅は、峰部および谷部の頂点において、該円筒形要素の他の部分よりも狭いことを特徴とする請求項1に記載の移植可能な管腔内グラフト。
- それぞれの連結部材は、波状の円筒形要素の峰部または谷部のいずれかと接続され、および該連結部材の中間部分の幅よりも狭い幅を有する、対立する端を有することを特徴とする請求項16に記載の移植可能な管腔内グラフト。
- (a) 37℃より高いオーステナイト相転移開始温度を有する形状記憶合金を含む微孔性金属薄膜被覆と、
(b) 少なくとも一対の円筒形要素と、隣接する円筒形要素を該円筒形要素の周囲に沿った同一の角度点で接合する連結部材とを含む、該微孔性金属薄膜被覆の下にある構造支持体要素であって、該構造支持体要素は、0℃未満のオーステナイト相転移開始温度を有する形状記憶合金をさらに含む構造支持体要素と
を含み、
(c)該微孔性金属薄膜被覆と該構造支持体要素との間の少なくとも1つの接触点によって、該構造支持体要素が該微孔性金属薄膜被覆に接着されている
ことを特徴とする移植可能な管腔内グラフト。 - 前記形状記憶合金はニチノールであることを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜被覆は、室温から体温への温度変化を通してマルテンサイト結晶構造を維持することを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 室温から体温への温度変化中に、マルテンサイト結晶構造からオーステナイト結晶構造への相転移を起こす構造支持体要素をさらに含むことを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記少なくとも1つの接触点は、該微孔性金属薄膜被覆の近位端または遠位端のいずれか、および該構造支持体要素の対応する端の近傍に位置することを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記少なくとも1つの接触点は、該微孔性金属薄膜被覆および該構造支持体要素の遠位端の近傍に位置することを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記円筒形要素は、交互の峰部および谷部を有する正弦曲線パターンを採ることを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記連結部材は、峰部−峰部または谷部−谷部のいずれかで隣接する円筒形要素を接合することを特徴とする請求項21に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜被覆は、該微孔性金属薄膜被覆の表面全体を通して均一なパターンの開口部を示すことを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記少なくとも1つの接触点は、末端連結部材の末端上にあることを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- 前記円筒形要素の幅は、頂点においておよび頂点の近傍において、該円筒形要素の他の部分よりも狭いことを特徴とする請求項17に記載の移植可能な管腔内グラフト。
- (a) ニチノールを含む微孔性金属薄膜被覆;および
(b) 複数の峰部および谷部を有する少なくとも一対の波状の円筒形要素と、該峰部または該谷部のいずれかにおいて隣接する円筒形要素を接合し、および末端の円筒形要素の谷部から縦軸方向に伸びる少なくとも1つの突出部を有する連結部材とを含む、該微孔性被覆の下にある構造支持体要素であって、ニチノールを含む構造支持体要素と
を含み、
(c)該構造支持体要素は、該少なくとも1つの突出部において該微孔性金属薄膜被覆と接合されている
ことを特徴とする移植可能な管腔内グラフト。 - 室温から体温への温度変化を通して、前記微孔性金属薄膜被覆はマルテンサイト結晶構造を維持することを特徴とする請求項27に記載の移植可能な管腔内グラフト。
- 前記構造支持体部材は、室温から体温への温度変化中に、マルテンサイト結晶構造からオーステナイト結晶構造への相転移を起こすことを特徴とする請求項28に記載の移植可能な管腔内グラフト。
- 室温から体温への温度変化を通してオーステナイト結晶構造を維持し、生体内でオーステナイト的に挙動する微孔性金属薄膜被覆をさらに含むことを特徴とする請求項27に記載の移植可能な管腔内グラフト。
- 室温から体温への温度変化中に、マルテンサイト結晶構造からオーステナイト結晶構造への相転移を起こし、生体内でオーステナイト的に挙動する微孔性金属薄膜被覆をさらに含むことを特徴とする請求項27に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜被覆は、該微孔性金属薄膜被覆の表面全体を通して規則的なパターンの開口部を示すことを特徴とする請求項28に記載の移植可能な管腔内グラフト。
- マグネトロン、カソード、該カソードと熱的に結合される冷却装置、および大気から選択的に隔離することができる堆積チャンバを有する真空スパッタ堆積装置中で、請求項1から31のいずれかに記載の金属薄膜を製造するための方法であって、該方法が:
(a) ニッケル、チタン、およびニッケル−チタン合金からなる群から選択される少なくとも1つのターゲットを、堆積チャンバ中に配置する工程と;
(b) 堆積チャンバ中に、ターゲットと空間的に離隔された基材を配置する工程と;
(c) 選択される作動気体を堆積チャンバに供給する工程と;
(d) スパッタされる粒子の平均自由行程が、ターゲットと基材との間の距離の約半分より大きい条件下で、前記少なくとも1つのターゲットから、材料をスパッタ堆積する工程と;
(e) 基材から、堆積された材料を取り外す工程と
を含むことを特徴とする方法。 - 工程(a)が、少なくとも1つのニッケルターゲットと、少なくとも1つのチタンターゲットとを提供することをさらに含むことを特徴とする請求項32に記載の方法。
- 前記カソードと前記ターゲットとは、少なくとも部分的に熱的に絶縁されていることを特徴とする請求項32に記載の方法。
- 前記スパッタ堆積装置が、ターゲットとカソードとの間の絶縁性接触における断熱性セラミック材料をさらに含むことを特徴とする請求項34に記載の方法。
- 前記基材の少なくとも1部は、約50nm未満のRa値の表面粗さを有することを特徴とする請求項32に記載の方法。
- 工程(c)における作動気体が、He、Ne、Ar、KrおよびXeからなる群から選択されることを特徴とする請求項32に記載の方法。
- 工程(d)に先だって、前記基材を、約400℃〜550℃の間の温度に加熱することを特徴とする請求項32に記載の方法。
- 工程(b)が、前記基材に対してバイアス電圧を供給することをさらに含むことを特徴とする請求項32に記載の方法。
- 前記バイアス電圧は負の電圧であることを特徴とする請求項39に記載の方法。
- 前記バイアス電圧は、約−120V以下であることを特徴とする請求項40に記載の方法。
- 工程(c)が、真空堆積システム中に、約0.1〜約30ミリトールの圧力までのArガスを導入する工程をさらに含むことを特徴とする請求項32に記載の方法。
- 工程(d)が、堆積基板とターゲットとの間の照射距離が約25mm未満になるように、堆積基板とターゲットとを配置する工程をさらに含むことを特徴とする請求項32に記載の方法。
- 前記基材が、円筒形基材であることを特徴とする請求項32に記載の方法。
- 工程(d)が、堆積される膜が管形状であるように、前記基材を回転させる工程をさらに含むことを特徴とする請求項44に記載の方法。
- 工程(d)が、スパッタ装置内部で、堆積されたニチノール膜を急冷する工程をさらに含むことを特徴とする請求項32に記載の方法。
- 堆積されたニチノール膜を視覚的に検査し、および堆積されたニチノール膜の光沢に基づいて堆積されたニチノール膜の表面粗さを定性的に決定する工程をさらに含むことを特徴とする請求項32に記載の方法。
- 前記金属薄膜が、少なくとも1000MPaの極限強度を有するニチノール膜から本質的に構成されていることを特徴とする請求項1から31のいずれかに記載の微孔性金属薄膜。
- 前記ニチノール膜が、少なくとも約10%の最大歪みを有することを特徴とする請求項48のニチノール膜。
- 前記金属薄膜が、何らの堆積後加工なしに、実質的に非柱状の微細構造を有するニチノール膜から本質的に構成されていることを特徴とする請求項1から31のいずれかに記載の微孔性金属薄膜。
- 前記ニチノール膜が、約500MPaより大きい極限強度を有することを特徴とする請求項50に記載のニチノール膜。
- 前記ニチノール膜が、約8%より大きい最大歪みを有することを特徴とする請求項51に記載のニチノール膜。
- 前記ニチノール膜が、ニッケルおよびチタンから本質的に構成されていることを特徴とする請求項50に記載のニチノール膜
- 前記ニチノール膜が、析出物を実質的に持たないことを特徴とする請求項53に記載のニチノール膜。
- 約1250MPaよりも大きい極限強度を有することを特徴とする請求項53に記載のニチノール膜。
- 約12%より大きい最大歪みを有することを特徴とする請求項55に記載のニチノール膜。
- 前記ニチノール膜が、約−20℃と−60℃との間の転移温度Apを有することを特徴とする請求項53に記載のニチノール膜。
- 前記微孔性金属薄膜および前記構造支持体要素の少なくとも1つが、マグネトロン、ターゲット、基材、該カソードと熱的に結合された冷却装置および大気から選択的に隔離することが可能な堆積チャンバを有する真空システム中でニチノールをスパッタ堆積する工程を含む方法によって製造され、
ターゲットから放出される粒子のエネルギーを、放出された粒子の平均自由行程がターゲットと基材との間の照射距離の約半分より大きいように制御することを特徴とする請求項1から31のいずれかに記載の移植可能な管腔内グラフト。 - 前記方法が、スパッタ堆積装置内部のカソードからターゲットを熱的に脱結合する工程をさらに含むことを特徴とする請求項58に記載の移植可能な管腔内グラフト。
- 前記方法が、スパッタ堆積実施中にターゲットを等温的に加熱する工程をさらに含むことを特徴とする請求項58に記載の移植可能な管腔内グラフト。
- 前記方法が、ターゲット材料のスパッタ堆積中、ターゲットを実質的に一定の温度に加熱する工程をさらに含むことを特徴とする請求項58に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜および前記構造支持体要素の少なくとも1つが、実質的に非柱状の結晶粒構造を有することによって特徴づけられる請求項58に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜および前記構造支持体要素の少なくとも1つが、500MPaより大きい極限強度を有することによって特徴づけられる請求項58に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜および前記構造支持体要素の少なくとも1つが、合金化されたニッケルおよびチタンから本質的に構成されることを特徴とする請求項58に記載の移植可能な管腔内グラフト。
- 前記微孔性金属薄膜および前記構造支持体要素の少なくとも1つが、ニチノール膜内部に実質的に析出物を持たないことによって特徴づけられる請求項64に記載の移植可能な管腔内グラフト。
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- 2003-09-19 CA CA2499961A patent/CA2499961C/en not_active Expired - Lifetime
- 2003-09-19 EP EP03752530.0A patent/EP1549248A4/en not_active Withdrawn
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JP2015509134A (ja) * | 2011-10-28 | 2015-03-26 | 韓国機械材料技術院 | チタン−ニッケル合金薄膜、及び同時スパッタリング法を用いたチタン−ニッケル合金薄膜の製造方法 |
JP2016507345A (ja) * | 2013-02-25 | 2016-03-10 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | 動脈疾患用薄膜血管ステント |
WO2017179716A1 (ja) * | 2016-04-15 | 2017-10-19 | 国立大学法人お茶の水女子大学 | シート材の弾性調整方法、フォースセンサ、及びシート材 |
JPWO2017179716A1 (ja) * | 2016-04-15 | 2019-04-11 | 国立大学法人お茶の水女子大学 | シート材の弾性調整方法、フォースセンサ、及びシート材 |
JP2022518927A (ja) * | 2019-02-01 | 2022-03-17 | ボルトン メディカル インコーポレイテッド | 拡張可能な管腔ステントおよび使用方法 |
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US7704274B2 (en) | 2010-04-27 |
WO2004028340A2 (en) | 2004-04-08 |
AU2003270817B2 (en) | 2009-09-17 |
EP1549248A4 (en) | 2015-11-25 |
CA2499961C (en) | 2014-12-30 |
US20180010230A1 (en) | 2018-01-11 |
AU2003270817A1 (en) | 2004-04-19 |
EP1549248A2 (en) | 2005-07-06 |
WO2004028340A3 (en) | 2004-08-26 |
JP4995420B2 (ja) | 2012-08-08 |
US20100217373A1 (en) | 2010-08-26 |
CA2499961A1 (en) | 2004-04-08 |
US9284637B2 (en) | 2016-03-15 |
US20200181753A1 (en) | 2020-06-11 |
US20040098094A1 (en) | 2004-05-20 |
US10465274B2 (en) | 2019-11-05 |
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