JP2014521486A - プラズマ改質医療デバイス及び方法 - Google Patents
プラズマ改質医療デバイス及び方法 Download PDFInfo
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Abstract
【選択図】 図1
Description
ステンレス鋼冠動脈ステントは、未拡張時に1.6mm(直径)×12mm(長さ)の寸法、及び20.66mm2の全露出表面積であった。ステントは、超音波槽において2%(v/v)洗剤8溶液により30分間50℃で洗浄した。次に、ステントを蒸留水にて30分50℃で超音波処理した。ステントに蒸留水で最後のすすぎをし、オーブンにて50℃で30分間乾燥させた。
長期安定性を評価するためにプラズマコーティング後最大12週間プラズマコーティング・ウェハに対して測定を行った。結果は、プラズマコーティング表面は、プラズマ処理後約2週間安定する傾向があり、DCプラズマを使用するTMSでコーティング後ΝΗ3/O2プラズマ処理をしたウェハ(図1)は、プラズマコーティング処理の12週間後、コーティングしていない対照と比較して非常に親水性のままであったことを示し、このことは、プラズマコーティング方法によって発生した長持ちする表面生物活性を示す。
かみそりの刃を使用してプラズマコーティング・ステンレス鋼ウェハに網目模様を付け、その後Scotch(登録商標)テープ引張り試験を行った。目視検査では、コーティングが網目を付けた領域又はその周辺領域からはがれていないことがわかり、下にある表面に強力に接着していることを示し、このことは、臨床用途においてステントを圧着、誘導及び拡張する際にステントが曲がったときコーティング統合性を保証するものである。
DCプラズマコーティングSSウェハをX線光電子分光法(XPS)により分析し、その結果を表2に示す。N及びO両方の元素組成が、TMSコーティング、その後のNH3/O2プラズマ表面改質を有する表面で増加したことがわかり、これは、オキシニトライト又はNO(一酸化窒素)官能基が表面に形成されたことを示す。表面上のこれらNO基の安定性は、プラズマ処理1週間後及び4週間後のウェハのN及びOの同様のレベルによって証明された。N(1s)の高解像度スペクトルの分析もNO形成を示した。
内皮回復は、重要な構造的機能及び抗血栓形成機能を与える血管の治癒に不可欠な要素である[Chin−Quee等、Biomaterials、31(4):648〜657頁、2010年]。Genlantis社(カリフォルニア州、San Diego)製ブタ冠動脈内皮細胞(EC)を内皮化の評価のために使用した。まず、標準プロトコルに従って、プラズマコーティングの1週間後のSSウェハに培養試験を実施した。図2に示す結果は、DC及びRFの両方のケースにおいてTMS単独でコーティングしたSSウェハに観察された細胞はないことを示す。TMSコーティング、その後のDC及びRFによるNH3/O2プラズマ表面改質は、培養の3日後に内皮細胞接着/成長がベアSSと比較して2.2から2.5倍の増加をもたらした。
プラズマコーティング又はプラズマ処理をしたステンレス鋼ウェハ、及びプラズマコーティング又はプラズマ処理をしていないステンレス鋼ウェハを各側に対して2時間UV光で滅菌し、その後、5群のそれぞれから2つのウェハを使用して24ウェルプレートに置いた。次に、50,000個のヒト冠動脈VSMC(カタログ番号:C−017−5C、Invitrogen社、カリフォルニア州、Carlsbad)を1つのウェハを含む各ウェル内に播種し、1日成長させた。次に、細胞を有するこれらのウェハを3%グルテルアルデヒドに固定し、トルイジンブルーで染色し、すすいだ。未結合の染料を除去するためにすすいだ後、次にウェハを落射蛍光顕微鏡によって調べ、デジタル写真を撮影した。次に、各顕微鏡写真視野の細胞数を数えた。図4は、DC−NH3/O2又はRF−NH3/O2によるプラズマコーティング・ウェハがベアステンレス鋼ウェハよりも平滑筋細胞付着が少ないことを示す。
以前と同じステント設置手順に従い、ブタ冠動脈内にステントを埋め込む、ブタを使用した大型動物試験を実施して[Tharp等、Arterioscler Thromb Vasc Biol、28(6):1084〜1089頁、2008年]、プラズマコーティングしたステントの性能を更に評価した。21日のエンドポイントで、動物研究の3つの区分(近位、中間及び遠位)のステント留置セグメントに組織分析を行った。ステント切片化は、HSRL Pathology(バージニア州、Mt.Jackson)にて行った。ImageJソフトウェア(Scion Image)を使用して2人の盲検調査官によって個別に分析を実施した。血管面積を外弾性板(EEL)で画定する面積として測定した。新生内膜(NI)面積を計算した(血管面積−内腔面積−中膜面積)。ステント留置セグメントの中膜面積に対する内膜面積の比率(I/M)を図5に示す。DC−NH3/O2コーティングしたステント(TMSコーティング、続いてDCプラズマによるNH3/O2プラズマ表面改質)は、冠動脈再狭窄の抑制がBMS対照よりも著しく良好であり(1つのステントのうち3つのステント区分に基づく対t検定でp<0.001)、平滑筋増殖の阻害、したがってステント内再狭窄の制限に大変見込みがあることを示す。
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Claims (24)
- 体液又は組織と接触する少なくとも1つの接触面を含む、ヒト又は動物宿主内に埋め込むように構成した医療デバイスであって、前記接触面は、1)プラズマ表面を生成するためのケイ素含有モノマーを使用するプラズマコーティングの薄層の成膜;及び2)次に、窒素含有分子及び酸素含有分子の混合物を使用する前記プラズマ表面の改質を含む2ステップ・プラズマ処理方法によって改質される、医療デバイス。
- 前記ケイ素含有モノマーは、通常条件で気体であるシラン基から選択される群を含む、請求項1に記載のデバイス。
- 前記ケイ素含有モノマーは、100℃未満の温度で気化することができるシラン基から選択される群を含む、請求項1に記載のデバイス。
- 前記ケイ素含有モノマーは、トリメチルシラン(TMS)、ビニルトリクロロシラン、テトラエトキシシラン、ビニルトリエトキシシラン、ヘキサメチルジシラザン、テトラメチルシラン、ビニルジメルヒルエトキシシラン、ビニルトリメトキシシラン、テトラビニルシラン、ビニルトリアセトキシシラン及びメチルトリメトキシシランからなるシラン基から選択される群を含む、請求項1に記載のデバイス。
- 前記ケイ素含有モノマーは、(CH3)3−SiH及び(CH3)2−SiH2からなるシラン基から選択される群を含む、請求項1に記載のデバイス。
- 前記窒素含有分子は、それぞれ6個以下の原子を含む、請求項1に記載のデバイス。
- 前記窒素含有分子は、それぞれ4個以下の原子を含む、請求項5に記載のデバイス。
- 前記窒素含有分子は、NH3、N2O、NO、NO2及びN2O4からなる群から選択される分子である、請求項1に記載のデバイス。
- 前記酸素含有分子は、O2及びO3からなる群から選択される分子である、請求項1に記載のデバイス。
- 窒素含有分子及び酸素含有分子による前記プラズマ表面改質は同時である、請求項1に記載のデバイス。
- 前記プラズマ改質接触面は、プラズマ改質しない同様の接触面と比較して少なくとも一部の哺乳類細胞への接着の向上を呈する、請求項1に記載のデバイス。
- 前記ヒト又は前記動物宿主は内皮細胞を含む、請求項10に記載のデバイス。
- 前記医療デバイスはステントであり、前記少なくとも1つの接触面はステントの内腔を含む、請求項1に記載のデバイス。
- 前記プラズマ改質接触面は、血管に設置した後にプラズマ改質しない同様のステントと比較して再狭窄の減少を呈する、請求項13に記載のデバイス。
- 前記プラズマコーティングの厚さは100nm未満である、請求項1に記載のデバイス。
- 前記プラズマコーティングの厚さは60nm未満である、請求項15に記載のデバイス。
- 前記プラズマコーティングの厚さは20nm未満である、請求項15に記載のデバイス。
- 前記プラズマコーティングの厚さは10から20nmの間である、請求項15に記載のデバイス。
- 前記プラズマ表面改質は約10分未満の間である、請求項1に記載のデバイス。
- 前記プラズマコーティング成膜は、前記ケイ素含有モノマーが(CH3)3−SiHであるプラズマの成膜である、請求項1に記載のデバイス。
- 前記プラズマコーティングの前記薄層は、グロー放電プラズマ成膜方法によって作製するナノスケール(100nm未満の)プラズマコーティングである、請求項1に記載のデバイス。
- 前記窒素含有分子はNH3であり、前記酸素含有分子はO2である、請求項1に記載のデバイス。
- 前記接触面は金属又はポリマー面である、請求項1に記載のデバイス。
- ステント、カテーテル、バルーン、シャント、移植片、弁、ペースメーカ、パルス発生器、心臓除細動器、脊髄刺激器、脳刺激器、リード、ねじ及びセンサを含む群から選択される、請求項1に記載のデバイス。
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US9603978B2 (en) | 2017-03-28 |
JP6132106B2 (ja) | 2017-05-24 |
WO2013025317A1 (en) | 2013-02-21 |
ES2663099T3 (es) | 2018-04-11 |
EP2744852A1 (en) | 2014-06-25 |
EP2744852A4 (en) | 2015-04-15 |
US20160184489A1 (en) | 2016-06-30 |
EP2744852B1 (en) | 2017-12-20 |
CN103748147B (zh) | 2016-07-06 |
US10016533B2 (en) | 2018-07-10 |
US20130046375A1 (en) | 2013-02-21 |
US20170296708A1 (en) | 2017-10-19 |
CN103748147A (zh) | 2014-04-23 |
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