JP6650436B2 - オリゴマー化されたポリフェノール層を含む、物品のコーティング、および、生物学的方法の使用 - Google Patents
オリゴマー化されたポリフェノール層を含む、物品のコーティング、および、生物学的方法の使用 Download PDFInfo
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- JP6650436B2 JP6650436B2 JP2017506898A JP2017506898A JP6650436B2 JP 6650436 B2 JP6650436 B2 JP 6650436B2 JP 2017506898 A JP2017506898 A JP 2017506898A JP 2017506898 A JP2017506898 A JP 2017506898A JP 6650436 B2 JP6650436 B2 JP 6650436B2
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Description
本非仮出願は、シリアルナンバーが62/035,173であり、2014年8月8日にファイルされ、タイトルが「ARTICLE COATINGS INCLUDING OLIGOMERIZED POLYPHENOL LAYER AND BIOLOGICAL METHODS OF USE」である仮出願が有する利益を請求する。当該仮出願は、その全体が、本非仮出願中に参考として援用される。
本発明は、医療用、診断用、および、細胞培養用の物品のためのコーティングに関する。
本発明の実施形態には、様々な物品(例えば、医療用、診断用、および、細胞培養用の物品)のためのコーティングが含まれる。本発明の実施形態には、また、コーティングされた物品を使用する方法が含まれる。
本発明は、以下の図面との関連において、より良く理解され得る。
本明細書における“ポリフェノール”は、2個〜約20個のフェノール単位(phenolic unit)を有する有機分子である。典型的なポリフェノールは、次の特性の1つ以上によって任意に特徴づけられ得る;つまり、(1)非重合体分子、(2)約200〜5000Daの範囲の分子量、(3)1つのフェノール単位あたり、1個〜3個のヒドロキシル基を有する、および、(4)1000Daあたり、5個〜8個の芳香環を有する。典型的なポリフェノールは、互いに結合している2個以上のフェノール単位を含む。典型的なポリフェノール単位は、レゾルシノール、ピロカテコール、ピロガロール、フロログルシノールおよびそれらの混合物から選択される。上記フェノール単位は、様々な化学基(例えば、エステル基、エーテル基、またはC−C基)を介して結合し得る。
まず、タンニン酸の繋ぎ目層を、ポリウレタン(PU)7F カテーテル(Solomon Scientific)の7cmの部分に塗布した。2mg/mLのタンニン酸(TA)溶液を調製するために、80mgのTAを、40mLの水性緩衝溶液中に溶解した。なお、当該水性緩衝溶液は、0.5M NaHCO3、および、0.5M NaCl(最終PH:8.3)を含むものであった。カテーテルの部分にタンニン酸溶液を加え、穏やかに反転させ、カテーテルの内腔から、付着しているあらゆる気泡を除去した。次いで、振とうさせること無く、50℃にて1時間、カテーテルをインキュベートした。インキュベーションの後、カテーテルの部分から除去し、内部直径(internal diameter)および外部直径(outer diameter)の両方を、水を用いて完全に洗浄し、空気乾燥を行った。
コーティングのタンパク質吸着特性を調べるために、ELISAの技術を用いて、コーティングされたカテーテル、および、コーティングされていないカテーテルに対するフィブリノーゲンの吸着を定量化した。ポリウレタンカテーテルを1cmの長さのサンプルに切り取り、12×75mmのガラスの試験管内に配置した(4サンプル/試験管)。ヒトの乏血小板血漿(George King Bio−Medical製のPPP)を、リン酸緩衝生理食塩水(PBS)を用いて、1:4に希釈した。2mLの希釈したPPPを、各試験管に加えた。サンプルを、室温にて2時間、オービタルシェーカー(orbital shaker)上で振とうしながら、インキュベートした。サンプルの血漿を吸引除去し、0.05%(v/v)Tween20、pH7.4を含むPBS洗浄溶液を用いて、サンプルを3回洗浄した。次いで、2mLの抗ヒトフィブリノーゲーンポリクローナル抗体−HRP(Rockland,Inc., 製品#200−103−240)を、PBS中で1:10,000に希釈されるように、各試験管に加えた。サンプルを、室温にて30分間、オービタルシェーカー上で振とうしながら、インキュベートした。抗体溶液を吸引除去し、PBSにTween20洗浄溶液を加えたものを用いて、サンプルを3回洗浄した。
表面修飾の血液親和性を決定するための有用な試験には、部分トロンボプラスチン時間(PTT(partial thromboplastin time))テストがある。当該PTTは、凝固における、固有(ファクターVIII、ファクターIX、ファクターXI、および、ファクターXII)の経路、および、共通(フィブリノーゲン、プロトロンビン、ファクターV、および、ファクターX)の経路に関するテストである。
Nunc maxisorb(最適なタンパク質の吸着に処理されたポリスチレン)、および、Greiner UV−Star(環状ポリオレフィン)の96ウェルのマイクロタイタープレートをタンニン酸によってコーティングし、次いで、典型的(model)な免疫アッセイによって試験した。
Claims (22)
- コーティングを備えた医療器具であって、
上記コーティングは、オリゴマー化されたポリフェノールを含む第1の被膜と、合成ポリマーまたは天然ポリマーを含む第2の被膜と、を含み、
上記合成ポリマーおよび天然ポリマーは、上記オリゴマー化されたポリフェノールに対して水素結合しており、
上記第1の被膜は、物品の表面と上記第2の被膜との間に配置されている、医療器具。 - 上記オリゴマー化されたポリフェノールは、500Da〜4000Daの分子量を有するポリフェノールを含んでいる、請求項1に記載の医療器具。
- 上記オリゴマー化されたポリフェノールは、12個以上のフェノール性ヒドロキシル基を有するポリフェノールを含んでいる、請求項1または2に記載の医療器具。
- 上記オリゴマー化されたポリフェノールは、没食子酸を含む組成物のエステル化によって得られるポリフェノールを含んでいる、請求項1〜3の何れか1項に記載の医療器具。
- 上記オリゴマー化されたポリフェノールは、タンニン酸を含んでいる、請求項1〜4の何れか1項に記載の医療器具。
- 上記第1の被膜および上記第2の被膜層は、厚さの合計が、250nm以下または100nm以下である、請求項1〜5の何れか1項に記載の医療器具。
- 上記合成ポリマーおよび天然ポリマーは、複数のヒドロキシル基を有している、請求項1〜6の何れか1項に記載の医療器具。
- 上記合成ポリマーは、ビニルピロリドン含有ポリマーである、請求項1〜7の何れか1項に記載の医療器具。
- 上記ビニルピロリドン含有ポリマーは、ビニルピロリドンホモポリマーまたはビニルピロリドン含有コポリマーである、請求項8に記載の医療器具。
- 更に、酸性基含有ポリマーを含む第3の被膜を含み、
上記第3の被膜は、上記第2の被膜と直接接触している、請求項1〜9の何れか1項に記載の医療器具。 - 上記酸性基含有ポリマーは、アクリル酸含有ポリマーである、請求項10に記載の医療器具。
- 上記アクリル酸含有ポリマーは、150kDa以上の平均分子量を有する、請求項11に記載の医療器具。
- 上記第2の被膜、上記第3の被膜、または、これらの両方が、更に、少なくとも1つの光反応性基を含んでいる、請求項10〜12の何れか1項に記載の医療器具。
- 上記光反応性基は、上記第2の被膜の合成ポリマー若しくは天然ポリマー、上記第3の被膜の酸性基含有ポリマー、または、これらの両方に付加しているものである、請求項13に記載の医療器具。
- 架橋剤中に存在する2つ以上の光反応性基を含む、請求項13または14に記載の医療器具。
- 上記オリゴマー化されたポリフェノールは、ポリフェノールを架橋する無機金属イオンを含む、請求項1〜15の何れか1項に記載の医療器具。
- 上記コーティングは、上記器具の内面上に形成されている、請求項1〜16の何れか1項に記載の医療器具。
- カテーテルを備えた、請求項1〜17の何れか1項に記載の医療器具。
- 上記オリゴマー化されたポリフェノールは、(a)フェノールとフェノールとの間の架橋を有する、脱プロトン化されたフェノール基、(b)無機イオンの配位結合を介したフェノールとフェノールとの間の架橋を有する、脱プロトン化されたフェノール基、または、当該(a)および(b)の両方、を含む、請求項1に記載の医療器具。
- 上記第1の被膜は、厚さが100nm未満である、請求項1に記載の医療器具。
- ポリフェノールを含む第1の被膜組成物を医療器具の表面に塗布して、オリゴマー化されたポリフェノールを含む第1の膜を形成する工程と、
上記第1の膜上に第2の被膜組成物を塗布する工程であって、上記第2の被膜組成物は、合成ポリマーまたは天然ポリマーを含み、当該合成ポリマーおよび天然ポリマーは、上記オリゴマー化されたポリフェノールに対して水素結合する、工程と、を含む、医療器具をコーティングする方法。 - 請求項1〜20の何れか1項に記載のコーティングを備えた医療器具を形成する、請求項21に記載の方法。
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