JP5937094B2 - 気道に使用する人口かさぶた - Google Patents
気道に使用する人口かさぶた Download PDFInfo
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- JP5937094B2 JP5937094B2 JP2013536780A JP2013536780A JP5937094B2 JP 5937094 B2 JP5937094 B2 JP 5937094B2 JP 2013536780 A JP2013536780 A JP 2013536780A JP 2013536780 A JP2013536780 A JP 2013536780A JP 5937094 B2 JP5937094 B2 JP 5937094B2
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Description
[0001]本出願は、2010年10月27日に出願された米国特許仮出願第61/407391号「気道に使用する人口かさぶた(ARTIFICIAL SCAB FOR USE IN AN AIRWAY)」の優先権を主張するものである。この米国特許仮出願の開示内容を、ここで参照することによって本願明細書に援用する。
[0050]キトサングルタメート(エフエムシー・バイオポリマー・エーエス(FMC BioPolymer AS)のノバマトリックス(NovaMatrix)ユニット製のPROTASAN(登録商標)UP G 213)と酸化でんぷん(シグマ・アルドリッチ(Sigma-Aldrich)製のP9265ポリマージアルデヒド)との50:50の混合物から、粉末混合物を生成した。以下の表では「実行第1号」としたこの混合物について、ハムスターの頬袋モデルを使用して、その生体内粘膜接着性を評価した。ハムスターの頬袋のそれぞれにおいて2か所、紙やすりで皮をめくって、その露出した表面にテスト試料を塗布した。動物たちにはカラーをつけて試料が剥がれてしまわないようにして、塗布のあと1日、3日、5日、7日後に目視で検査を行い、滞留期間を評価した。また、粉末状混合物を湿らせたソーセージの皮の欠片にも塗布し、混合物が古くなっていくうちに気道を塞いでしまう危険性が発生するかどうかについて、医者団によって客観的に判断してもらった。同様の粘膜接着性と気道閉塞についての評価を、PCT出願公開番号:WO2009/132229A2に記載の通りに低温電子線ビーム(cold e-beam)で滅菌した酸化でんぷんとして、モノマー・ポリマー及びダジャック・ラボ社(Monomer-Polymer and Dajac Labs, Inc.)製のジアルデヒドスターチ(Dialdehyde Starch)9056を使用して生成した試料(実行第2号)において行った。その他7つの市販されている又は実験により生成可能なシーリング材(実行第3〜9号)を同様に評価した。以下の表にその結果を示す。
[0052]実施例1における実行第1号の粉末状混合物を、犬の扁桃摘出術モデルを使用して評価し、組織学的分析を通して、無治療対照と比較して刺激性がないものと判断された。第2の犬扁桃摘出術テストを行い、様々な電気焼灼器切除の設定を使用し、また、粉体の塗布直後に潅注工程を実行して、その止血作用を評価した。電気焼灼器の設定に関わらずすべての部位において粉末状混合物は問題なく接着し、止血効果を発揮することが分かった。塗布された粉末状混合物は潅注後であってもその場に留まり続けた。扁桃床の治癒についても検査したが、その結果は、電気焼灼器設定が低いほど、治癒効果が高いということを示した。
[0053]実施例1における実行第1号の粉末状混合物を、豚肝臓生検パンチ止血モデルにおいて評価した。当該混合物は、可撓性のある背部を有するキトサンをベースとした止血材料である、ヘムコム・メディカルテクノロジーズ社(HemCon Medical Technologies, Inc.)製のHemCom(登録商標)包帯が示す機能と同様の機能を示し、止血手段として認められるものであると評価された。
[0054]第3の犬扁桃摘出術テストを行い、治療の効能を評価した。塗布から10日後、実施例1の実行第2号の粉末状混合物によって治療した創傷部位は、無治療対照の部位と比較して約50%小さくなっていた。
Claims (7)
- 少なくとも部分的に溶媒和可能であるキトサン粒子と少なくとも部分的に溶媒和可能である酸化多糖粒子よりなる、乾燥した自由流動性の粉末状混合物を含む組成物であって、
前記粉末状混合物は、体液で湿潤した手術部位又は創傷部位に付着されることにより、該粉末状混合物の粒子が該体液の存在に基づいて架橋的反応を生じて互いに付着して不均一で非結合の固形シート状体を形成し、当該固形シート状体を形成する前記粒子どうしの結合力は、該固形シート状体の前記手術部位又は創傷部位に対する結合力より小さい、組成物。 - 体液で湿潤した手術部位又は創傷部位に付着する不均一で非結合の固形シート状体を含む人工かさぶたを形成する組成物であって、
前記固形シート状体は、キトサン粒子及び多糖粒子からなって前記手術部位又は創傷部位に付着されることにより、該体液の存在に基づいて互いに付着し合っている粒状混合物を具備し、当該固形シート状体を形成する前記粒子どうしの結合力は、該固形シート状体の前記手術部位又は創傷部位に対する結合力より小さい、組成物。 - 請求項1又は2記載の組成物において、
前記キトサンが、500kDaより高い数平均分子量を有する塩を含む、又は前記酸化多糖が、酸化セルロース、キチン、キトサン、コンドロイチン硫酸、デキストラン、グリコーゲン、及びヒアルロン酸のうちのいずれかを含む、組成物。 - 請求項1又は2記載の組成物において、
前記キトサンがグルタミン酸塩を含み、前記酸化多糖が酸化でんぷんを含む、組成物。 - 請求項1又は2記載の組成物において、
10〜90wt%のキトサンと、90〜10wt%の酸化多糖とを含む、組成物。 - 請求項1又は2記載の組成物において、
さらに、抗菌剤、鎮痛薬、抗-コリン作動薬、抗真菌剤、抗ヒスタミン剤、ステロイド性又は非ステロイド性抗炎症剤、抗寄生虫剤、抗ウイルス剤、生物静力学的組成物、化学療法剤又は抗腫瘍剤、サイトカイン、充血除去剤、追加の止血剤、免疫抑制剤、粘液溶解剤、核酸、ペプチド、タンパク質、ステロイド、血管収縮剤、ビタミン、及びこれらの組合せのいずれかを含む、組成物。 - 請求項2記載の組成物において、
前記手術部位又は創傷部位は気道内にあり、前記人工かさぶたは1日より長く2週間より短い滞留期間を有する、組成物。
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US40739110P | 2010-10-27 | 2010-10-27 | |
US61/407,391 | 2010-10-27 | ||
PCT/US2011/057893 WO2012058312A1 (en) | 2010-10-27 | 2011-10-26 | Artificial scab for use in an airway |
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