JPWO2006027994A1 - 生体留置用ステント - Google Patents
生体留置用ステント Download PDFInfo
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- JPWO2006027994A1 JPWO2006027994A1 JP2006535706A JP2006535706A JPWO2006027994A1 JP WO2006027994 A1 JPWO2006027994 A1 JP WO2006027994A1 JP 2006535706 A JP2006535706 A JP 2006535706A JP 2006535706 A JP2006535706 A JP 2006535706A JP WO2006027994 A1 JPWO2006027994 A1 JP WO2006027994A1
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
- A61L2300/608—Coatings having two or more layers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
- A61L2300/608—Coatings having two or more layers
- A61L2300/61—Coatings having two or more layers containing two or more active agents in different layers
Abstract
Description
ステントの本体は、当業者が通常作製する方法と同様に、ステンレス鋼(SUS316L)の内径1.50mm、外径1.80mmの筒状チューブをレーザーカットによりステントデザインにカットし、電解研磨を施すことで作製した。使用したステントの展開図を図1に、模式図を図2に示した。ステント長さを13mm、厚みを120μm、拡張後の公称径を3.5mmとした。ステントはバルーンエクスパンダブルタイプと言われるもので、カテーテルの先端部付近にバルーンを備えたバルーンカテーテルを使ってステントを拡張・留置するタイプのものである。バルーンエクスパンダブルタイプのステントはバルーンカテーテルのバルーン部分に収縮された状態でセットされ、目的個所までデリバリーされた後、バルーンを拡張することで拡張・留置される。
薬剤濃度/高分子濃度=0.75wt%/0.50wt%である溶液を作製し、ステント1個あたりの高分子の重量が66μg、薬剤の重量が100μgである内層(薬剤/高分子重量比=1.52)を形成させた以外は実施例1と同様に作製した。
薬剤濃度/高分子濃度=0.05wt%/0.50wt%である溶液を作製し、ステント1個あたりの高分子の重量が500μg、薬剤の重量が50μgである外層(薬剤/高分子重量比=0.10)を形成させた以外は実施例1と同様に作製した。
薬剤濃度/高分子濃度=0.75wt%/0.50wt%である溶液を作製し、ステント1個あたりの高分子の重量が66μg、薬剤の重量が100μgである内層(薬剤/高分子重量比=1.52)を形成させ、薬剤濃度/高分子濃度=0.20wt%/0.50wt%である溶液を作製し、ステント1個あたりの高分子の重量が125μg、薬剤の重量が50μgである外層(薬剤/高分子重量比=0.40)を形成させた以外は実施例1と同様に作製した。
薬剤濃度/高分子濃度=0.25wt%/0.50wt%である溶液を作製し、ステント1個あたりの高分子の重量が200μg、薬剤の重量が100μgである内層(薬剤/高分子重量比=0.50)を形成させた以外は実施例1と同様に作製した。
ステントの本体は、当業者が通常作製する方法と同様に、ステンレス鋼(SUS316L)の内径1.50mm、外径1.80mmの筒状チューブをレーザーカットによりステントデザインにカットし、電解研磨を施すことで作製した。使用したステントの展開図を図1に、模式図を図2に示した。ステント長さを13mm、厚みを120μm、拡張後の公称径を3.5mmとした。ステントはバルーンエクスパンダブルタイプと言われるもので、カテーテルの先端部付近にバルーンを備えたバルーンカテーテルを使ってステントを拡張・留置するタイプのものである。バルーンエクスパンダブルタイプのステントはバルーンカテーテルのバルーン部分に収縮された状態でセットされ、目的個所までデリバリーされた後、バルーンを拡張することで拡張・留置される。
薬剤濃度/高分子濃度=0.13wt%/0.50wt%である溶液を作製し、ステント1個あたりの高分子の重量が580μg、薬剤の重量が150μgであるコーティング層(薬剤/高分子重量比=0.26)を形成させた以外は比較例1と同様に作製した。
3.5×15mmのバルーンを備えたPTCAバルーンカテーテルを試作し、バルーン部に上述のステントをマウントさせた。室温・空気中の条件でバルーンを8atm(810kPa)で拡張し、ステントを拡張させた。1分後バルーン内を減圧し、ステントからバルーンを取り外した。拡張した状態のステントを電子顕微鏡観察用の試料台に固定し、Pt−Pd合金を蒸着した後、走査型電子顕微鏡(S−3000N、株式会社日立ハイテクノロジーズ)にて表面を観察した。コーティングの割れおよび剥がれの発生頻度を定性的に評価した結果を表1に示す。また、コーティングの割れおよび剥がれの典型的な例として、図3に実施例1のSEM観察像を、図4に比較例1のSEM観察像を示す。
実施例1および2、比較例1および2について薬剤の溶出試験を行った。35%メタノールを含有する酸性リン酸緩衝液(pH3.4,NaCl:6.1g/L,NaH2PO4・2H2O:7.1g/L,H3PO4:263μL/L)100mLに各ステント1個を浸漬させ、37℃水浴中で振盪させた。一定時間ごとに1mLずつサンプリング後、等量の新鮮な緩衝液を補充し、試験液の総量は常に100mLになるようにした。サンプリング液中のタクロリムス濃度をHPLC(アライアンス、日本ウォーターズ株式会社)で定量し、次式に従い溶出率を算出した。結果(データ)を表2に、図5にグラフを示す。
溶出率(%)=サンプリング液中のタクロリムス濃度(wt%)/ステント全体のタクロリムスがすべて緩衝液に溶出した場合のタクロリムス濃度(wt%)×100
Claims (17)
- ほぼ管状体に形成されるステントであって、前記ステントは前記管状体の半径方向外方に伸長可能であり、前記ステントは、ステント基材として、生体内で非分解性の材料を含むステント本体と、前記ステント本体表面の少なくとも一部に薬剤および高分子を含むコーティング層とを備え、前記コーティング層は内層および外層から構成され、各層ごとに含まれる重量で定義した薬剤/高分子重量比が前記内層の方が高く、かつ前記外層に有効量の薬剤が含まれることを特徴とする生体留置用ステント。
- 前記ステント本体の外表面、内表面および側表面のほぼ全面に前記コーティング層を有することを特徴とする請求項1記載の生体留置用ステント。
- 前記高分子が生分解性高分子であることを特徴とする請求項1に記載の生体留置用ステント。
- 前記生分解性高分子がポリ乳酸、ポリグリコール酸、および乳酸−グリコール酸共重合体から選ばれる少なくとも1種であることを特徴とする請求項3記載の生体留置用ステント。
- 前記内層を構成する高分子の生分解期間と前記外層を構成する高分子の生分解期間がほぼ同等であることを特徴とする請求項4記載の生体留置用ステント。
- 前記内層を構成する高分子の生分解期間が前記外層を構成する高分子の生分解期間よりも長いことを特徴とする請求項4記載の生体留置用ステント。
- 前記内層に含まれる薬剤と前記外層に含まれる薬剤が同一であることを特徴とする請求項1から6のいずれかに記載の生体留置用ステント。
- 前記薬剤が免疫抑制剤であることを特徴とする請求項7記載の生体留置用ステント。
- 前記免疫抑制剤がタクロリムス(FK506)、シクロスポリン、シロリムス(ラパマイシン)、アザチオプリン、マイコフェノレートモフェチルおよびこれらのアナログから選ばれる少なくとも1種であることを特徴とする請求項8記載の生体留置用ステント。
- 前記免疫抑制剤がタクロリムス(FK506)であることを特徴とする請求項9記載の生体留置用ステント。
- 前記内層に含まれる薬剤と前記外層に含まれる薬剤が異なることを特徴とする請求項1から6のいずれかに記載の生体留置用ステント。
- 前記内層に含まれる薬剤が免疫抑制剤、前記外層に含まれる薬剤が抗炎症剤であることを特徴とする請求項11記載の生体留置用ステント。
- 前記免疫抑制剤がタクロリムス(FK506)、シクロスポリン、シロリムス(ラパマイシン)、アザチオプリン、マイコフェノレートモフェチルおよびこれらのアナログから選ばれる少なくとも1種であり、前記抗炎症剤がデキサメタゾン、ヒドロキシコルチゾン、コルチゾン、デソキシコルチコステロン、フルドロコルチゾン、ベータメタゾン、プレドニゾロン、プレドニゾン、メチルプレドニゾロン、パラメタゾン、トリアムシノロン、フルメタゾン、フルオシノロン、フルオシノニド、フルプレドニゾロン、ハルシノニド、フルランドレノリド、メプレドニゾン、メドリゾン、コルチゾール、6α−メチルプレドニゾロン、トリアムシノロン、ベータメタゾン、サリチル酸誘導体、ジクロフェナク、ナプロキセン、スリンダク、インドメタシン、およびこれらのアナログから選ばれる少なくとも1種であることを特徴とする請求項12記載の生体留置用ステント。
- 前記免疫抑制剤がタクロリムス(FK506)であり、前記抗炎症剤がデキサメタゾンであることを特徴とする請求項13記載の生体留置用ステント。
- 前記内層における薬剤/高分子重量比が0.50以上1.60以下であることを特徴とする請求項1に記載の生体留置用ステント。
- 前記外層における薬剤/高分子重量比が0.10以上0.40以下であることを特徴とする請求項1に記載の生体留置用ステント。
- 前記内層における薬剤/高分子重量比が0.50以上1.60以下であり、かつ前記外層における薬剤/高分子重量比が0.10以上0.40以下であることを特徴とする請求項1に記載の生体留置用ステント。
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JP2006535706A JP4894519B2 (ja) | 2004-09-08 | 2005-09-01 | 生体留置用ステント |
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JP2006535706A JP4894519B2 (ja) | 2004-09-08 | 2005-09-01 | 生体留置用ステント |
PCT/JP2005/016002 WO2006027994A1 (ja) | 2004-09-08 | 2005-09-01 | 生体留置用ステント |
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US (1) | US20070250157A1 (ja) |
EP (1) | EP1792582B1 (ja) |
JP (1) | JP4894519B2 (ja) |
KR (1) | KR20070056122A (ja) |
CN (1) | CN101052362A (ja) |
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EP1792582A1 (en) | 2007-06-06 |
JP4894519B2 (ja) | 2012-03-14 |
KR20070056122A (ko) | 2007-05-31 |
US20070250157A1 (en) | 2007-10-25 |
EP1792582B1 (en) | 2018-04-04 |
EP1792582A4 (en) | 2012-06-20 |
CN101052362A (zh) | 2007-10-10 |
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