JP5068672B2 - 改良された金属合金ステントを形成する方法 - Google Patents
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Description
以下に図面を参照し、本発明が、物理的形態およびある部品においてとる、および部品の配置をとる様々な実施の形態を説明する。
チューブを工程段階160で洗浄した後、次いで、チューブを、図1で説明するようなステントの形態に切断する。分かるように、他のステントの設計を、工程段階170で述べるような切断工程中に形成することができる。チューブの切断を、典型的にはレーザーによって行なう。チューブを加熱するために使用されたビーム強度が、少なくとも2350℃の切削温度を得ることができるように、チューブを切断するために使用されるレーザーを選択する。使用することができるレーザーの限定しない例は、パルスYAG−NDまたはCO2レーザーを含む。レーザーによるチューブの切断は、アルゴンおよび1〜10体積パーセントの水素雰囲気などの酸素還元雰囲気で行う;しかし、真空雰囲気、不活性雰囲気または他のタイプの酸素還元雰囲気を使用することができる。チューブの切断中に、チューブを、切断工程中にチューブの振動を抑制するまたは防止するように、典型的には安定させ、チューブを切断する場合、振動は、チューブ中のミクロクラックの形成をもたらす可能性がある。切断工程中のチューブに汚染物を導入しないように、チューブを、典型的には、モリブデン、レニウム、タングステン、モリブデンTZM合金、セラミックなどからなる装置によって固定する;しかし、これは必須ではない。チューブの切断の間に、振動の平均振幅は、典型的には、チューブの肉厚の約50%以下である。そのため、肉厚が、約0.0024インチであるチューブについては、切断工程中のチューブの振動の平均振幅は、約0.0012インチ以下である。
30 管状の形成体
32 第1の端部
34 第2の端部
36 第1の端部と第2の端部との間に配置された部材構造
Claims (51)
- a)表面および外周断面積を有するとともに、金属合金から形成されるロッドまたはチューブであって、前記金属合金が第一次金属、炭素、酸素、窒素および不純物から構成され、前記金属合金の99重量%以上が前記第一次金属、炭素、酸素および窒素で形成され、前記金属合金の重量%の大部分は、第一次金属で占められ、前記第一次金属が、レニウム、モリブデン、カルシウム、クロム、コバルト、銅、金、鉄、鉛、マグネシウム、ニッケル、ニオブ、白金、希土類金属、銀、タンタル、タングステン、イットリウム、亜鉛およびジルコニウムからなる群の中から選ばれる2またはそれ以上の金属を含むロッドまたはチューブを形成するステップと、
b)各低減プロセスの間に、減少機構によって、前記ロッドまたはチューブを少なくとも1回低減させて、前記ロッドまたはチューブの前記外周断面積を25%未満まで低減させた第1の低減断面積を得るステップと、
c)前記ロッドまたはチューブの前記外周断面積を50%より大きくなるまで低減させる前に、前記ロッドまたはチューブを第1の焼きなまし温度で焼きなますステップと、
d)低減および焼きなましステップ後に、前記ロッドまたはチューブの前記金属合金が、炭素を200ppmまで含有し、酸素を100ppmまで含有するとともに、前記低減ステップと焼きなましステップの間に、前記ロッドまたはチューブの環境をコントロールして、前記金属合金中に含まれる炭素および酸素の原子比率を2:1以上50:1以下に調整するステップと、を有する、
ことを特徴とする医療用部材の製造方法。 - 前記ロッドまたはチューブを形成するステップは、前記低減および焼きなましステップの前に、金属粉を一体に静水圧プレスし、次いで、前記金属粉を焼結して、前記ロッドまたはチューブを形成する工程を有する、
ことを特徴とする請求項1に記載の医療用部材の製造方法。 - 前記金属粉を一体に静水圧プレスするステップによって、前記金属合金の最小理論密度の0.7〜0.95の平均密度を有するロッドまたはチューブが形成される、
ことを特徴とする請求項2に記載の医療用部材の製造方法。 - 前記金属粉は、200メッシュ未満の平均粒径を有する、
ことを特徴とする請求項2または3に記載の医療用部材の製造方法。 - 前記静水圧プレスされた金属粉を焼結するステップによって、前記金属合金の最小理論密度の0.9〜0.99の平均密度を有するロッドまたはチューブが形成される、
ことを特徴とする請求項2乃至4のいずれか1項に記載の医療用部材の製造方法。 - 前記静水圧プレスされた金属粉を焼結するステップによって、平均密度が12〜14gm/ccのロッドまたはチューブが形成される、
ことを特徴とする請求項2乃至5のいずれか1項に記載の医療用部材の製造方法。 - 前記静水圧プレスされた金属粉を焼結するステップを、不活性雰囲気、酸素還元雰囲気または真空中で実行する、
ことを特徴とする請求項2乃至6のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブを形成するステップは、
前記ロッドに穴を開けて、前記ロッドの長手方向の少なくとも一部を通る通路を形成する工程と、
前記通路の表面を研磨する工程と、を有する、
ことを特徴とする請求項1乃至7のいずれか1項に記載の医療用部材の製造方法。 - 前記通路は、ガンドリル加工、放電加工による切断およびこれらの組み合わせによって形成される、
ことを特徴とする請求項8に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブを酸素から保護するステップを含む、
ことを特徴とする請求項1乃至9のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブの前記外周断面積を前記減少機構で低減するステップによって、前記外周断面積は、前記ロッドまたはチューブが前記減少機構によって処理されるごとに20%未満減少される、
ことを特徴とする請求項1乃至10のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブの前記外周断面積を前記減少機構で低減するステップによって、前記外周断面積は、前記ロッドまたはチューブが前記減少機構によって処理されるごとに15%未満減少される、
ことを特徴とする請求項1乃至11のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブの前記外周断面積を前記減少機構で低減するステップによって、前記外周断面積は、前記ロッドまたはチューブが前記減少機構によって処理されるごとに10%未満減少される、
ことを特徴とする請求項1乃至12のいずれか1項に記載の医療用部材の製造方法。 - 前記減少機構は、プラグ引き抜き工程を有する、
ことを特徴とする請求項1乃至13のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブの前記外周断面積を低減するステップの少なくとも一部を、不活性雰囲気、酸素還元雰囲気または真空で実行する、
ことを特徴とする請求項1乃至14のいずれか1項に記載の医療用部材の製造方法。 - 前記各低減ステップ後に、前記ロッドまたはチューブの表面を洗浄するステップを有する、
ことを特徴とする請求項1乃至15のいずれか1項に記載の医療用部材の製造方法。 - 前記各焼きなましステップ前に、前記表面を洗浄するステップを実行する、
ことを特徴とする請求項16に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブの前記外周断面積を45%よりも大きく低減する前に、前記ロッドまたはチューブを焼きなますステップを実行する、
ことを特徴とする請求項1乃至17のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブを焼きなますステップを、温度1300℃以上で2分以上実行する、
ことを特徴とする請求項1乃至18のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブを焼きなますステップの少なくとも一部を、不活性雰囲気、酸素還元雰囲気または真空中で実行する、
ことを特徴とする請求項1乃至19のいずれか1項に記載の医療用部材の製造方法。 - 焼きなましステップを1回以上実行する前に、前記チューブを複数回低減する、
ことを特徴とする請求項1乃至20のいずれか1項に記載の医療用部材の製造方法。 - 前記低減ステップの間に、潤滑剤を使用するステップを有し、
前記潤滑剤には、モリブデンが含まれる、
ことを特徴とする請求項1乃至21のいずれか1項に記載の医療用部材の製造方法。 - 前記ロッドまたはチューブの前記外周断面積を低減するステップの後に、ロッドまたはチューブの表面を洗浄するステップを実行する、
ことを特徴とする請求項1乃至22のいずれか1項に記載の医療用部材の製造方法。 - 前記焼きなましたロッドまたはチューブの少なくとも一部を、前記医療用部材に切断するステップを含む、
ことを特徴とする請求項1乃至23のいずれか1項に記載の医療用部材の製造方法。 - 前記切断ステップの少なくとも一部は、レーザによって実行される、
ことを特徴とする請求項24に記載の医療用部材の製造方法。 - 前記切断ステップには、前記ロッドまたはチューブの少なくとも一部を切断するときに、前記ロッドまたはチューブの振動を抑制するために、前記ロッドまたはチューブを拘束するステップが含まれる、
ことを特徴とする請求項24または25に記載の医療用部材の製造方法。 - 前記拘束するステップには、前記レーザで前記チューブの壁厚を50%よりも大きく切断しているときに、前記チューブの振動が、レーザ切断によって前記チューブの平均振動振幅よりも大きくなる間、前記焼きなましたチューブを安定させる工程が含まれる、
ことを特徴とする請求項26に記載の医療用部材の製造方法。 - 前記切断ステップの少なくとも一部を、不活性雰囲気、酸素還元雰囲気または真空中で実行する、
ことを特徴とする請求項24乃至27のいずれか1項に記載の医療用部材の製造方法。 - 前記切断ステップ後に、前記医療用部材を電解研磨するステップを有する、
ことを特徴とする請求項24乃至28のいずれか1項に記載の医療用部材の製造方法。 - 前記医療用部材は、ステント、グラフト、バルブ、ビス、爪、ロッド、PFO装置、人口器官、シース、ガイドワイヤー、バルーンカテーテル、皮下注射筒、カテーテル、電気生理学的カテーテル、止め金または切断部材である、
ことを特徴とする請求項1乃至29のいずれか1項に記載の医療用部材の製造方法。 - 前記医療用部材は、ステントである、
ことを特徴とする請求項30に記載の医療用部材の製造方法。 - 前記医療用部材の少なくとも1つの領域上に、少なくとも1つの生物学的作用物質を適用する工程を含む、
ことを特徴とする請求項1乃至31のいずれか1項に記載の医療用部材の製造方法。 - 前記医療用部材の少なくとも1つの領域に少なくとも1つのポリマーを適用して、前記少なくとも1つの生物学的作用物質を少なくとも部分的に被覆し、カプセル化し、または被覆してカプセル化する工程を含む、
ことを特徴とする請求項32に記載の医療用部材の製造方法。 - 前記低減および焼きなましステップが完了した後に、前記チューブは最終的に0.095インチ未満の壁厚を有する、
ことを特徴とする請求項1乃至33のいずれか1項に記載の医療用部材の製造方法。 - 前記チューブはステントとして形成され、該ステントは0.0027インチ未満の壁厚を有する、
ことを特徴とする請求項1乃至34のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金が、レニウム、モリブデン、必要に応じて加えられる金属添加物、炭素、酸素、窒素および不純物から構成され、前記レニウムと前記モリブデンの含有量は、前記金属合金の95重量%以上を占め、前記レニウムの含有量は、前記金属合金の40重量%以上を占め、前記モリブデンの含有量は、前記金属合金の40重量%以上を占める、
ことを特徴とする請求項1乃至35のいずれか1項に記載の医療用部材の製造方法。 - 前記レニウムとモリブデンの含有量は、前記金属合金の99重量%以上を占める、
ことを特徴とする請求項36に記載の医療用部材の製造方法。 - 前記レニウムとモリブデンの含有量は、前記金属合金の99.95重量%以上を占める、
ことを特徴とする請求項37に記載の医療用部材の製造方法。 - 前記レニウムの含有量は、前記金属合金の40〜55重量%であり、前記モリブデンの含有量は、前記金属合金の45〜60重量%である、
ことを特徴とする請求項37または38に記載の医療用部材の製造方法。 - 前記レニウムの含有量は、前記金属合金の40〜50重量%であり、前記モリブデンの含有量は、前記金属合金の50〜60重量%である、
ことを特徴とする請求項36乃至39のいずれか1項に記載の医療用部材の製造方法。 - 前記レニウムの含有量は、前記金属合金の45〜50重量%であり、前記モリブデンの含有量は、前記金属合金の50〜55重量%である、
ことを特徴とする請求項36乃至40のいずれか1項に記載の医療用部材の製造方法。 - 前記レニウムの含有量は、前記金属合金の46〜49重量%であり、前記モリブデンの含有量は、前記金属合金の51〜54重量%である、
ことを特徴とする請求項36乃至41のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金は、窒素を20ppm未満含有し、炭素を150ppm未満含有し、酸素を75ppm未満含有する、
ことを特徴とする請求項36乃至42のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金は、窒素を20ppm未満含有し、炭素を150ppm未満含有し、酸素を50ppm未満含有する、
ことを特徴とする請求項36乃至43のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金の前記炭素の含有量は100ppm未満であり、前記金属合金の前記酸素の含有量は50ppm未満である、
ことを特徴とする請求項36乃至44のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金の前記炭素の含有量は50ppm未満であり、前記金属合金の前記酸素の含有量は10ppm未満である、
ことを特徴とする請求項36乃至45のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金の前記窒素の含有量は10ppm未満である、
ことを特徴とする請求項36乃至46のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金中の炭素と酸素の原子比率は、20:1までに調整される、
ことを特徴とする請求項36乃至47のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金は、炭素と酸素の原子比率が2:1以上、炭素と窒素の原子比率が40:1未満、酸素と窒素の原子比率が30:1未満にそれぞれ調整され、
前記医療用部材の少なくとも1つの領域には、少なくとも1つの生物学的作用物質が含まれる、
ことを特徴とする請求項36乃至48のいずれか1項に記載の医療用部材の製造方法。 - 前記金属合金は、炭素と酸素の原子比率が2.5〜10:1に調整される、
ことを特徴とする請求項36乃至49のいずれか1項に記載の医療用部材の製造方法。 - 前記必要に応じて加えられる金属添加物は、前記金属合金の2重量%未満を占め、
前記必要に応じて加えられる金属添加物は、チタン、イットリウムおよびジルコニウムからなる群の中から選ばれる1または複数の金属を有する、
ことを特徴とする請求項36乃至50のいずれか1項に記載の医療用部材の製造方法。
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WO2006096251A2 (en) | 2006-09-14 |
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AU2006221058A1 (en) | 2006-09-14 |
EP1858440A4 (en) | 2011-03-30 |
US7648591B2 (en) | 2010-01-19 |
EP1868528A2 (en) | 2007-12-26 |
EP1858440A2 (en) | 2007-11-28 |
WO2006096263A2 (en) | 2006-09-14 |
EP1868528B1 (en) | 2024-05-22 |
WO2006096263A3 (en) | 2007-04-05 |
US20090068249A1 (en) | 2009-03-12 |
US20060198750A1 (en) | 2006-09-07 |
EP1868528A4 (en) | 2011-04-06 |
AU2006221046B2 (en) | 2012-02-02 |
EP1858440B1 (en) | 2024-04-24 |
US7540994B2 (en) | 2009-06-02 |
WO2006096251A3 (en) | 2009-04-30 |
AU2006221058B2 (en) | 2012-02-02 |
JP2008531191A (ja) | 2008-08-14 |
JP2008538933A (ja) | 2008-11-13 |
JP5335244B2 (ja) | 2013-11-06 |
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