JP2013508033A - 組織を分離する脂肪酸癒着障壁 - Google Patents
組織を分離する脂肪酸癒着障壁 Download PDFInfo
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Abstract
Description
本出願は、2009年10月19日に出願された米国出願第12/581,582号(これは、2005年9月28日に出願された「Barrier Layer」との表題の米国特許出願第11/237,420号;2005年9月28日に出願された「A Stand−Alone Film and Methods for Making the Same」との表題の米国特許出願第11/237,264号:2007年10月30日に出願された「Coated Surgical Mesh」との表題の米国特許出願第11/978,840号;および2009年3月10日に出願された「Fatty−Acid Based Particles」との表題の米国特許出願第12/401,243号の一部継続出願である)に対する優先権を主張し、その利益を主張する。上記特許出願の内容は、本明細書中に参考として援用される。
本発明は、一般に、組織を分離する癒着障壁に関する。
医療用フィルムは、外科的介入又は鈍的切開後に、ある種の器官を隣接する組織及び医療機器から分離して手術後の癒着形成を最小化するのに役立つ物理的障壁として外科的状況でしばしば使用される。例えば、マサチューセッツ州ケンブリッジのGenzyme Corporationの製品であるSEPRAFILM(登録商標)(化学修飾糖で構成されたフィルム)は、異なる組織及び器官と移植可能な医療デバイス(例えば、軟部組織支持膜及びメッシュ、または非吸収性材料とメッシュとの組合せなど)との間での手術後の癒着形成の発生率、程度及び重症度を低下させるように意図された移植可能な処理として、腹部又は骨盤の手術に使用される。
以下でより詳細に記述するように、カルボキシメチルセルロース(「CMC」)またはNa−CMCなどの固着材料で構築された、魚油製フィルムなどの脂肪酸ベースのフィルムは、フィルムを固着させてフィルムの移動を防止するために設けることができる。CMCの炎症性の特徴、並びにCMC及びNa−CMCの急速な再吸収性にもかかわらず、癒着障壁は体による忍容性が良好であり、非炎症性であり、目標部位から移動せず、CMCの架橋を必要としない。本発明の癒着障壁は、許容される移植後持続期間(例えば、7日間を超える)まで再吸収を効果的に遅延させる。脂肪酸ベースのフィルムとCMCまたはNa−CMCなどの固着材料との組合せは、予想外の相乗効果をもたらす。特に、脂肪酸ベースのフィルムの存在下の非架橋CMCは、脂肪酸の存在下ではない架橋CMCほど急速には体に吸収されない。その結果、癒着障壁の固着部分は、別のCMCベースのフィルムよりもはるかに遅い速度で体に吸収されて、癒着が形成される可能性がある期間にわたって障壁機能が発揮される。
本発明の例示的態様及び実施形態は、脂肪酸ベースのフィルム又は脂肪酸ベースの粒子から形成された癒着障壁を提供する。癒着障壁は、CMCベースのフィルムなどの材料の固着特性を有し、さらに予想外の相乗効果を有し、癒着障壁の組織固着部分が吸収される速度をCMC成分の架橋を必要とせずにかなり低下させる。
一部の従来製品においては、ポリ(エチレングリコール)、ポリ(エチレンオキシド)、ポリ(HEMA)、ポリ(N−ビニルピロリドン)、ポリ(アクリル酸)、カルボキシメチルセルロース(CMC)、キトサンなどの親水性組織固着成分を使用して、フィルムを固着させる。この固着は、フィルム易動度又は移動の問題に対処することができる。しかし、これらの親水性材料は、かなりの異物反応及び炎症を示すおそれがあり、これらは望ましくない特性である(例えば、欧州特許出願第20020080404号参照)。
従来の癒着障壁とは対照的に、本発明の実施形態は、障壁機能を発揮するに十分な時間にわたって目標部位に存在し、CMC成分を架橋する必要がなく、著しい炎症反応を誘発しない、癒着障壁を提供する。本発明の例示的実施形態によれば、脂肪酸由来の生体材料で構成された脂肪酸ベースのフィルム又は脂肪酸ベースの粒子は、再吸収可能な、組織を分離する癒着障壁材料として使用される。オメガ3脂肪酸及びオメガ6脂肪酸は、例えば魚油から得ることができる脂肪酸の例である。オメガ3脂肪酸としては、エイコサペンタエン酸(EPA:eicosapentaenoic acid)、ドコサヘキサエン酸(DHA:docosahexanoic acid)及びアルファ−リノレン酸(ALA:alpha−linolenic acid)が挙げられる。
図1は、本発明の一実施形態による癒着障壁100を示す。癒着障壁100は、脂肪酸ベースのフィルム110を含む。脂肪酸ベースのフィルム110は、当該技術分野で公知の方法のいずれかによって形成することができる。一実施形態においては、架橋された脂肪酸由来の生体材料は、天然であり得る、又は合成供給源から誘導され得る、油を含み、脂肪酸ベースのフィルム110の形成に使用される。架橋された脂肪酸由来の生体材料は、魚油を含めて、少なくとも1種類の脂質又はオメガ3脂肪酸を含む油などの生物学的油を含むことができる。生体材料は、さらに、ビタミンEを含むことができる。
図5は、本発明の別の一代替実施形態を示す。図5に示す癒着障壁500は、CMCと水との混合物などの乳濁液基剤520と混合された脂肪酸ベースの粒子510の乳濁液である。
実験台上での剥離力−非滅菌試料
脱イオン水中の置換度0.65の2%(w/v)非架橋高分子量Na−CMC(Sigma)で構成されたコーティング溶液を15枚の1平方インチの脂肪酸ベースのフィルムに塗布し、乾燥させて、本発明の実施形態による癒着障壁を形成した。試験前に水道水ですすいだ新たに屠殺されたウシの腸に癒着障壁を置いた。癒着障壁を組織上に試験前に3分間放置した。Chatillonゲージを使用して、癒着障壁と組織との間の癒着面に平行な方向の剥離力を測定した。Chatillonゲージで測定された各試料の最大力を収集した。15枚のコーティングされていない脂肪酸ベースのフィルムを参照用に測定した。コーティングされていないフィルムの平均剥離力は0.08lbfであった。それに対して、本発明の実施形態による癒着障壁を形成するコーティングされたフィルムの平均剥離力は0.54lbfであった。
組織間の癒着を最小限にする脂肪酸−CMCフィルムのインビボでの結果
本発明の例示的実施形態による癒着障壁の試験試料を実施例1の上記方法によって作製した。CMCは架橋を増強するように改変されず、架橋促進剤も使用されなかった。試験試料を癒着防止のウサギ側壁モデルに移植した。試料を22.5kGyの線量で電子線を使用して滅菌した。盲腸を十分に擦過して、点状出血させ、腹膜の3×5cm切片を切り出した。このモデルは、未処理の動物では高密度の癒着を生じる。CMCでコーティングされた4×6cmのO3FAフィルムを腹膜の欠損部上にコーティング側を側壁に直接接触させて配置した。移植から28日後に、ウサギを屠殺し、癒着面積を等級分けした。
放射線曝露による架橋は、CMC水性組成物のインビボでの残存時間を増加させるのに使用することができる方法である。乾燥CMCフィルムに対する放射線曝露の効果を評価するために、SWFI中の置換度0.7の2%(w/v)Na−CMC(Hercules)で構成された溶液をSWFIで溶液:SWFI比5:2に希釈した。希薄溶液をTeflon(登録商標)でコーティングされたウェルプレートに注ぎ、室温で24時間乾燥させて、CMCの薄い固体フィルムを得た。フィルムを幾つかの四角い小片に切断し、別々に包装した。幾つかの小片を、10MeV電子線源を使用して22.5kGyの線量で照射した。照射試料及び非照射試料を別々のアルミニウムパンの脱イオン水に浸漬し、溶解度、及び構造の維持/喪失を評価した。CMCフィルムが放射線曝露によって架橋された場合、フィルムは水和すると、最初の四角形状を維持しながらやや膨潤するはずである。それに対して、照射フィルムおよび非照射フィルムの両方とも膨潤し、約10分以内に構造を失い、30分でもはや固体としてもゲルとして検出できなかった。これは、両方の試料においてCMCが十分に移動性である(架橋も他の方法での化学結合による固定もされない)ことを示す。パンのCMC溶液を周囲室温で48時間蒸発させると、パン底面に丸いパン形状に合わせてCMCの均一に薄い固体フィルムが生成した。曝露と非曝露のCMCフィルムの完全に等しい溶解度は、電子線曝露がCMC材料の移動性を構造上制限(すなわち架橋)しなかったことの証拠である。
SWFI中の置換度0.7の2%(w/v)Na−CMC(Hercules)及び1%グリセリンで構成されたコーティング溶液を調製した。コーティング溶液を幾つかの脂肪酸ベースのフィルムに塗布し、乾燥させて癒着障壁を形成した。コーティングは十分可塑化されたので、癒着障壁は優れた取扱い性を示した。癒着障壁を22.5kGyの線量の電子線で滅菌し、癒着のウサギ側壁モデルに移植した。盲腸を十分に擦過して、点状出血させ、腹膜の3×5cm切片を切り出した。CMCでコーティングされた4×6cmフィルムを腹膜の欠損部上にコーティング側を側壁に直接接触させて配置した。移植から28日後に、ウサギを屠殺し、癒着面積を等級分けした。
組織固着キトサンコーティングを有するO3FAフィルム
1%酢酸溶液中の4%(w/v)ChitoPharm S(MW=50,000〜1,000,000、Cognis)で構成されたコーティング溶液を、分子量カットオフ3,500のFisherbrand再生セルロース透析管膜を使用して透析した。最終コーティング溶液のpHは6.27であった。コーティングを幾つかの4×6cm O3FAフィルムに塗布し、癒着防止のウサギ側壁モデルにおいて評価した。試料を22.5kGyの線量で電子線を使用して滅菌した。盲腸を十分に擦過して、点状出血させ、腹膜の3×5cm切片を切り出した。このモデルは、未処理の動物では高密度の癒着を生じる。キトサンでコーティングされた4×6cmフィルムを腹膜の欠損部上にコーティング側を側壁に直接接触させて配置した。移植から28日後に、ウサギを屠殺し、癒着面積を等級分けした。結果を下表に示す。
乳濁液
図5に示した乳濁液の形の癒着障壁を図6に記載の手順に従って調製した。乳濁液の試料を試験まで4℃で貯蔵した。
本発明によって記述される脂肪酸ベースの生体材料を製造するプロセスは、油の酸化に関する文献の伝統的な科学報告に鑑みて、幾つかの予想外の化学プロセス及び特性をもたらしたs(J.Dubois et al.JAOCS.1996,Vol.73,No.6.,pgs787−794.H.Ohkawa et al.,Analytical Biochemistry,1979,Vol.95,pgs351−358.;H.H.Draper,2000,Vol.29,No.11,pgs1071−1077)。油酸化は、伝統的に、生体適合性であるとは考えられないヒドロペルオキシドおよびアルファ−ベータ不飽和アルデヒドなどの反応性副生物の形成という理由から油硬化手順の関心事である。(H.C.Yeo et al.Methods in Enzymology.1999,Vol.300,pgs70−78.;S−S.Kim et al.Lipids.1999,Vol.34,No.5,pgs489−496)。しかし、油及び脂肪に由来する脂肪酸の酸化は、インビボでの生化学プロセスの制御において自然であり、重要である。例えば、炎症の促進又は抑制などのある生化学的経路の調節は、様々な脂質酸化生成物によって制御される(V.N.Bochkov and N.Leitinger,J.Mol Med.2003;Vol.81,pgs613−626)。さらに、オメガ3脂肪酸は、ヒトの健康に重要であることが知られており、特にEPA及びDHAはインビボでの抗炎症性を有する。しかし、EPA及びDHAはそれ自体抗炎症性ではないが、それらが生化学的に変換された酸化副生物は、インビボで抗炎症効果を示す(V.N.Bochkov and N.Leitinger,2003;L.J.Roberts II et al.The Journal of Biological Chemistry.1998;Vol.273,No.22,pgs13605−13612)。従って、生体適合性ではないある種の油酸化生成物が存在するが、ポジティブな生化学的性質をインビボで有する幾つかの別のものも存在する(V.N.Bochkov and N.Leitinger,2003;F.M.Sacks and H.Campos.J Clin Endocrinol Metab.2006;Vol.91,No.2,pgs398−400;A.Mishra et al.Arterioscler Thromb Vasc Biol.2004;pgs1621−1627)。したがって、適切なプロセス条件を選択することによって、好都合な生物学的性能をインビボで有する最終化学プロファイルを含む油酸化の化学的性質を利用して、油から誘導された架橋疎水性生体材料を生成し、制御することができる。
一般に、4つのタイプの軟部組織:上皮組織(例えば、皮膚ならびに血管及び多数の器官の内層)、結合組織(例えば、腱、じん帯、軟骨、脂肪、血管及び骨)、筋肉(例えば、骨格(横紋筋)、心筋又は平滑筋)、並びに神経組織(例えば、脳、脊髄及び神経)がヒトに存在する。本発明による癒着障壁は、これらの軟部組織領域の傷害の処置に使用することができる。したがって、一実施形態においては、本発明の癒着障壁は、創傷治癒のための軟部組織の増殖の促進に使用することができる。さらに、急性外傷後、軟部組織は、治癒及びリハビリプロセスの結果として、変化し、順応することができる。かかる変化としては、ある種の組織がその組織では正常でない形態に変換されることである化生、組織の異常な発達である異形成、正常な組織配置にある正常細胞の過剰増殖である過形成、並びに細胞死及び再吸収又は細胞増殖低下に帰因する組織サイズの減少である萎縮が挙げられるが、それだけに限定されない。したがって、本発明の脂肪酸由来の生体材料は、軟部組織における急性外傷に付随又は起因する少なくとも1つの症候の縮小又は軽減に使用することができる。
Claims (49)
- 組織抗癒着性を有する脂肪酸ベースの材料、及び
該脂肪酸ベースの材料の表面の上又は周囲に配置された親水性組織固着材料
を含む、癒着障壁であって、
該癒着障壁が非炎症性であって、組織にインビボで10日間を超える持続期間にわたって固着するように、該脂肪酸ベースの材料及び該組織固着材料が該癒着障壁を形成する、癒着障壁。 - 前記脂肪酸ベースの材料が、架橋された脂肪酸由来の生体材料から誘導される、請求項1に記載の癒着障壁。
- 前記脂肪酸ベースの材料が魚油から製造される、請求項1に記載の癒着障壁。
- 前記組織固着材料がカルボキシメチルセルロース(CMC)を含む、請求項1に記載の癒着障壁。
- 前記組織固着材料が、カルボキシメチルセルロースナトリウム(Na−CMC)、ポリ(エチレングリコール)、ポリ(エチレンオキシド)、ポリ(HEMA)、ポリ(N−ビニルピロリドン)、ポリ(アクリル酸)、カルボキシメチルセルロース(CMC)及びキトサンの群のうちの一つを含む、請求項1に記載の癒着障壁。
- 前記脂肪酸ベースの材料が脂肪酸ベースのフィルムであり、前記組織固着材料が前記脂肪酸ベースのフィルムの一面のみに配置される、請求項1に記載の癒着障壁。
- 前記組織固着材料がポリアニオン性多糖である、請求項1に記載の癒着障壁。
- 前記脂肪酸ベースの材料が、前記脂肪酸ベースのフィルムが存在しない場合に前記組織固着材料に付随する炎症を低減する、請求項1に記載の癒着障壁。
- 前記癒着障壁に可塑剤を添加することを更に含む、請求項1に記載の癒着障壁。
- 前記可塑剤が、グリセリン、プロピレングリコール、ポリエチレングリコール、トリアセチンシトラート及びトリアセチンの群のうちの一つを含む、請求項9に記載の癒着障壁。
- 脂肪酸由来の生体材料から誘導されるフィルム、及び
該フィルム全体に配置される組織固着材料
を含む、癒着障壁であって、
該癒着障壁が非炎症性であって、組織にインビボで10日間を超える持続期間にわたって固着するように、該フィルム及び該組織固着材料が該癒着障壁を形成する、癒着障壁。 - 前記組織固着材料が、前記フィルムを包囲する組織固着コーティングを含む、請求項11に記載の癒着障壁。
- 前記組織固着材料が前記フィルムの一部として設けられる、請求項11に記載の癒着障壁。
- 前記フィルムがオメガ3脂肪酸ベースのフィルムである、請求項11に記載の癒着障壁。
- 前記脂肪酸由来の生体材料が架橋される、請求項11に記載の癒着障壁。
- 前記脂肪酸由来の生体材料が魚油を含む、請求項11に記載の癒着障壁。
- 前記組織固着材料がポリアニオン性多糖を含む、請求項11に記載の癒着障壁。
- 前記組織固着材料がカルボキシメチルセルロース(CMC)を含む、請求項11に記載の癒着障壁。
- 前記組織固着材料がカルボキシメチルセルロースナトリウム(Na−CMC)を含む、請求項11に記載の癒着障壁。
- 前記脂肪酸由来の生体材料が、前記脂肪酸ベースのフィルムが存在しない場合に前記組織固着材料に付随する炎症を抑制する、請求項11に記載の癒着障壁。
- 前記癒着障壁が術後癒着を防止するのに十分な残存時間を有する、請求項11に記載の癒着障壁。
- 可塑剤を更に含む、請求項11に記載の癒着障壁。
- 前記可塑剤が、グリセリン、プロピレングリコール、ポリエチレングリコール、トリアセチンシトラート及びトリアセチンの群のうちの一つを含む、請求項22に記載の癒着障壁。
- 癒着障壁が非炎症性であって、組織にインビボで10日間を超える持続期間にわたって固着するように、組織抗癒着特性を有する脂肪酸ベースのフィルム及び親水性組織固着材料で形成された癒着障壁を調製する方法であって、
該脂肪酸ベースのフィルムを提供すること、
該組織固着材料を提供すること、及び
該脂肪酸ベースのフィルムを該組織固着材料と組み合わせて該癒着障壁を形成すること
を含む、方法。 - 前記脂肪酸ベースのフィルムが、架橋された脂肪酸由来の生体材料から誘導される、請求項24に記載の方法。
- 前記脂肪酸ベースのフィルムが魚油から製造される、請求項24に記載の方法。
- 前記組織固着材料がカルボキシメチルセルロース(CMC)を含む、請求項24に記載の方法。
- 前記組織固着材料が、カルボキシメチルセルロースナトリウム(Na−CMC)、ポリ(エチレングリコール)、ポリ(エチレンオキシド)、ポリ(HEMA)、ポリ(N−ビニルピロリドン)、ポリ(アクリル酸)、カルボキシメチルセルロース(CMC)及びキトサンの群のうちの一つを含む、請求項24に記載の方法。
- 前記脂肪酸ベースのフィルムが配置された外科的部位から移動しない、請求項24に記載の方法。
- 前記組織固着材料が前記脂肪酸ベースのフィルムの一面のみに配置される、請求項24に記載の方法。
- 前記組織固着材料が前記脂肪酸ベースのフィルムの1面よりも多くの面の前記脂肪酸ベースのフィルムをコーティングする、請求項24に記載の方法。
- 前記組織固着材料が前記脂肪酸ベースのフィルム全体に配置される、請求項24に記載の方法。
- 前記組織固着材料がポリアニオン性多糖である、請求項24に記載の方法。
- 前記脂肪酸ベースのフィルムが、前記脂肪酸ベースのフィルムが存在しない場合に前記組織固着材料に付随する炎症を低減する、請求項24に記載の方法。
- 可塑剤を前記コーティングに添加することを更に含む、請求項24に記載の方法。
- 前記可塑剤が、グリセリン、プロピレングリコール、ポリエチレングリコール、トリアセチンシトラート及びトリアセチンの群のうちの一つを含む、請求項35に記載の方法。
- 脂肪酸由来の生体材料から誘導される脂肪酸ベースの粒子、及び
組織密着性材料を含む乳濁液基剤
を含む、癒着障壁であって、
該脂肪酸ベースの粒子が該乳濁液基剤と混合されて、該癒着障壁が非炎症性であって、組織にインビボで10日間を超える持続期間にわたって密着するように、該癒着障壁を形成する、癒着障壁。 - 前記脂肪酸ベースの粒子が、前記乳濁液基剤と混合される前に、治療薬に浸漬される、請求項37に記載の癒着障壁。
- 前記脂肪酸ベースの粒子の平均粒径が約1ミクロンと約50ミクロンとの間である、請求項37に記載の癒着障壁。
- 前記脂肪酸ベースの粒子の平均粒径が約1ミクロンと約10ミクロンとの間である、請求項39に記載の癒着障壁。
- 前記脂肪酸ベースの粒子が約1〜20μmのサイズ分布を有する、請求項37に記載の癒着障壁。
- 前記脂肪酸ベースの粒子が約21〜40μmのサイズ分布を有する、請求項37に記載の癒着障壁。
- 前記脂肪酸ベースの粒子が約41〜150μmのサイズ分布を有する、請求項37に記載の癒着障壁。
- 前記脂肪酸ベースの粒子がオメガ3脂肪酸ベースの粒子である、請求項37に記載の癒着障壁。
- 前記脂肪酸由来の生体材料が架橋される、請求項37に記載の癒着障壁。
- 前記脂肪酸由来の生体材料が魚油を含む、請求項37に記載の癒着障壁。
- 前記組織密着性材料がポリアニオン性多糖を含む、請求項37に記載の癒着障壁。
- 前記組織密着性材料がカルボキシメチルセルロース(CMC)を含む、請求項37に記載の癒着障壁。
- 前記組織密着性材料がカルボキシメチルセルロースナトリウム(Na−CMC)を含む、請求項37に記載の癒着障壁。
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JP5778159B2 (ja) | 2015-09-16 |
WO2011049833A1 (en) | 2011-04-28 |
US9278161B2 (en) | 2016-03-08 |
EP2490618A1 (en) | 2012-08-29 |
CN102753118B (zh) | 2016-01-20 |
US20180133376A1 (en) | 2018-05-17 |
US20100183697A1 (en) | 2010-07-22 |
US9844611B2 (en) | 2017-12-19 |
US20160206789A1 (en) | 2016-07-21 |
EP2490618A4 (en) | 2014-05-07 |
US11083823B2 (en) | 2021-08-10 |
CN102753118A (zh) | 2012-10-24 |
JP6096844B2 (ja) | 2017-03-15 |
JP2015198983A (ja) | 2015-11-12 |
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