JP3784798B2 - ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ - Google Patents
ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ Download PDFInfo
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- JP3784798B2 JP3784798B2 JP2003356680A JP2003356680A JP3784798B2 JP 3784798 B2 JP3784798 B2 JP 3784798B2 JP 2003356680 A JP2003356680 A JP 2003356680A JP 2003356680 A JP2003356680 A JP 2003356680A JP 3784798 B2 JP3784798 B2 JP 3784798B2
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
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- Composite Materials (AREA)
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- Materials For Medical Uses (AREA)
- Prostheses (AREA)
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Description
さらに、拡張したPTFE動脈プロテーゼは、周囲の組織により、微孔のある構造の細胞の浸透とコラーゲンの析出が少ないという欠点がある。従って、血液との適合性と組織結合性能を改善しようとする多くの開発は不十分であった。例えば、グイドインらにより報告されたバイオマテリアル1993年14巻、9号の「拡張したPTFEの組織変化」の研究では、e−PTFEの微孔のある構造の細胞の浸透が最小であると述べられている。グラフト表面上に内皮細胞の単層を作る開発で、低温保存し、培養した人体潜伏静脈の内皮細胞が、強化したPTFEプロテーゼ上で培養された。プロテーゼ上に内皮細胞を供給する前に、グラフト表面が人体のフィブロネクチンでプレコートされる。カデレッツらにより報告された胸部心臓外科35(1987 )143-147 頁の「低温保存した潜伏静脈の内皮細胞によるフィブロネクチンでコーティングしたPTFEグラフトの生体外ライニング」の研究では、落胆するような結果を報告している。より最近、e−PTFEグラフト上の内皮細胞を供給する前にプレコート材料としてフィブロネクチンと共にラミニン、コラーゲンタイプI/IIIを使用した研究が、カーラーらにより行われ、導管外科雑誌9巻4号4月(1989)に「プレコート基体と表面構成が、ポリテトラフルオロエチレングラフト上に供給した内皮細胞の付着と広がりを決める」として報告された。この研究はフィブロネクチンとタイプI/IIIコラーゲンでプレコートした表面上で、細胞の付着と細胞の広がりは、明らかに優れていると報告している。
沖田らに与えられた米国特許第4,193,138 号は、チューブの孔が水溶性ポリマーで満たされた多孔性PTFEチューブからなる複合構造を開示する。水溶性ポリマーは、e−PTFEチューブに塞栓しない性質を与える親水性層を形成するために使用される。このようなポリマーの例としては、ポリビニルアルコール、ポリエチレンオキサイド、ポリアクリル酸とポリメタクリル酸等の窒素含有ポリマーと非イオン性ポリマーがある。さらに、セルロースと多糖類のヒドロキシエステル又はカルボキシエステルも開示されている。この特許は、水溶性ポリマーがチューブの孔内に拡散し、次に乾燥することを記述する。次に水に不溶にするため水溶性ポリマーの架橋処理を行う。熱処理、アセタール化、エステル化、イオン化放射線誘導架橋反応等の架橋処理が開示される。この特許に開示される水溶性材料はその性質上人工のものである。
いったん生物学的適合性材料がe−PTFEの基体のボイド内で固まり、即ち架橋すると、固体を自然に拘束する表面として働き、さらに内皮細胞の付着と組織が内へ延びることを促進する傾向があり、これはプロテーゼの適正な受容と治癒に非常に重要である。前述したように、本発明以前には、PTFEの表面の不活性の化学的性質のため、内皮細胞を付着させるよい方法はなく、そのため内皮の細胞を容易に剥離するようになった。本発明は、このような欠点を克服しようとするものである。重要なことであるが、本発明の構造はe−PTFE構造を取り外すのに役立つ。また、縫合孔からの出血を減らすことができる。
それゆえ、本発明のプロテーゼは、e−PTFEの自然の抗血栓性能と血栓の形成の一因となる傾向のあるコラーゲンの性質のバランスをとり、一方で組織が内部に延びるため血液を通さない硬い表面を与えなければならないのは明らかである。
他のタイプも使用することができるが、タイプIコラーゲンは本発明に使用するには好適なコラーゲンである。この分子は、平均長さ300nm、平均直径約1.4nmのロッド状構造である。トロホコラーゲンと言われるこれらのロッドは、3つのα連鎖からなる。個々の連鎖は、約1,000 のアミノ酸からなる左巻螺旋である。左巻螺旋は相互に巻きつき、大きな右巻螺旋を形成する。
コラーゲンの他の重要な性質は、全血に晒されると凝固反応を始めることである。従って、プロテーゼのボイドにあるコラーゲンは、埋め込み中と埋め込みの直後に、プロテーゼが漏れるのを防止する。
一実施例では、本発明のe−PTFEプロテーゼを作成する方法は、生物学的適合性材料の分散を生じさせる力を使い、プロテーゼのチューブ状壁に浸透させ、それにより節間のボイドに接触させることを含む。チューブ状プロテーゼの端部をクランプし、生物学的適合性、生物分解性材料の分散で内腔を満たし、圧力をかけてe−PTFEの壁の隙間内に分散の移動を起こさせるすることにより行うことができるが、これは多くの方法で行うことができる。分散の管腔を超える流れにより、生物学的適合性、生物分解性材料とボイドの間の十分な接触をすることができると信じられる。浸透する時間は、e−PTFEの孔の大きさ、グラフトの長さ、浸透圧、コラーゲンの濃度、他の要因によるが、例えば30℃から35℃の好適な温度範囲で1分以下から10分までの一般に短時間で行うことができる。しかし、ボイドが生物学的適合性、生物分解性材料でほぼ満たされたとしてもこれらの限界は重要ではない。可溶の生物学的適合性、生物分解性材料は、適所で固まるように選択的に架橋処理を行うことができる。例えば、各種架橋剤に晒すことによる架橋が行われ、ホルムアルデヒド蒸気等の方法で行われるのが好ましい。架橋したコラーゲンの形成に続いて、次にプロテーゼをリンスし、公知の方法で滅菌する準備をすることができる。過度の水分と架橋剤を除去するため、真空乾燥又は熱処理を使用することができる。所望の含浸を得るのに必要により、e−PTFEを分散/溶液と接触させる全工程を数回繰り返すことができる。
プロテーゼに含浸させる前に生物学的適合性の分散に、抗菌薬、抗ウイルス薬、抗生物質、発育因子、ヘパリン等の血液凝固阻止薬等の各種薬理学的活性剤をその混合物、複合層も同様に添加することができる。
本発明の他の実施例では、コラーゲン又はゼラチン分散はプロテーゼに晒す前に不溶化することができる。これはもちろん、プロテーゼの含浸と隙間のボイドを満たすのをいくらか困難にする。
10,11・・壁
12・・ボイド
13・・生分解性材料
14・・節
15・・フィブリル
20・・チューブ状プロテーゼ
30・・パッチ
Claims (8)
- 節と、節間の空間と、前記節を相互接続するフィブリルとを含む微孔性の壁構造を有する拡張したポリテトラフルオロエチレン(e−PTFE)チューブ状プロテーゼであって、前記節間の空間が、固体不溶性、生物学的適合性材料で含浸されたチューブ状プロテーゼを作成する方法において、
酸性pHで、コラーゲン、ゼラチン、ビトロネクチン、フィブロネクチン、ラミニン、再構成した基部膜マトリックス、及びそれらの混合物からなる群から選択された細胞外マトリックス蛋白質を含む可溶の生物学的適合性、生物分解性材料の分散又は溶液を作成し、
前記節間の空間を前記可溶の生物学的適合性材料で含浸させるため、前記プロテーゼを前記分散又は溶液と接触させ、
前記分散又は溶液のpHを大きくして、前記可溶の生物学的適合性、生物分解性材料を沈殿させて不溶性の状態にし、前記節間の空間が、前記不溶の生物学的適合性、生物分解性材料でほぼ満たされるようにするステップを含むことを特徴とする方法。 - 請求項1に記載した方法であって、
固体不溶性、生物学的適合性、生物分解性材料を形成するため、前記沈殿は緩衝剤を加えた燐酸塩溶液で処理することで行われることを特徴とする方法。 - 請求項2に記載した方法であって、
前記固体不溶性、生物学的適合性、生物分解性材料は、アルデヒド蒸気に晒すことで架橋されることを特徴とする方法。 - 請求項1に記載した方法であって、
前記e−PTFE構造は、水溶性ポリマーの溶液に浸漬することにより親水性にされることを特徴とする方法。 - 請求項4に記載した方法であって、
前記水溶性ポリマーは、ポリビニルアルコール、ポリエチレンオキサイド、ポリエチレングリコール、メチルセルロース、エチルセルロース、ヒドロキシセルロース、ヒドロキシプロピルセルロースからなる群から選択される、酸素含有炭化水素であることを特徴とする方法。 - 請求項4に記載した方法であって、
前記水溶性ポリマーは、ポリアクリルアミド、ポリビニルピロリドン、ポリビニルアミン、ポリエチレンアミンからなる群から選択される、窒素含有ポリマーであることを特徴とする方法。 - 請求項1に記載した方法であって、
前記プロテーゼを滅菌溶液でリンスするステップを備えることを特徴とする方法。 - 請求項7に記載した方法であって、
前記リンスするステップは、酸化エチレン溶液で処理することを含むことを特徴とする方法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US08/289,790 US5665114A (en) | 1994-08-12 | 1994-08-12 | Tubular expanded polytetrafluoroethylene implantable prostheses |
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JP20545695A Division JP3563498B2 (ja) | 1994-08-12 | 1995-08-11 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
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JP2006000572A Division JP4526487B2 (ja) | 1994-08-12 | 2006-01-05 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
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JP2004136093A JP2004136093A (ja) | 2004-05-13 |
JP3784798B2 true JP3784798B2 (ja) | 2006-06-14 |
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JP20545695A Expired - Fee Related JP3563498B2 (ja) | 1994-08-12 | 1995-08-11 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
JP2003356680A Expired - Fee Related JP3784798B2 (ja) | 1994-08-12 | 2003-10-16 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
JP2006000572A Expired - Fee Related JP4526487B2 (ja) | 1994-08-12 | 2006-01-05 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
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JP20545695A Expired - Fee Related JP3563498B2 (ja) | 1994-08-12 | 1995-08-11 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
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JP2006000572A Expired - Fee Related JP4526487B2 (ja) | 1994-08-12 | 2006-01-05 | ポリテトラフルオロエチレン製の埋め込み可能なチューブ状プロテーゼ |
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US (2) | US5665114A (ja) |
EP (1) | EP0698395B2 (ja) |
JP (3) | JP3563498B2 (ja) |
CA (1) | CA2147565C (ja) |
DE (1) | DE69525692T3 (ja) |
DK (1) | DK0698395T3 (ja) |
ES (1) | ES2173939T3 (ja) |
FI (1) | FI952218A (ja) |
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- 1995-05-08 FI FI952218A patent/FI952218A/fi not_active Application Discontinuation
- 1995-05-31 US US08/455,714 patent/US5716660A/en not_active Expired - Lifetime
- 1995-08-11 JP JP20545695A patent/JP3563498B2/ja not_active Expired - Fee Related
-
2003
- 2003-10-16 JP JP2003356680A patent/JP3784798B2/ja not_active Expired - Fee Related
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2006
- 2006-01-05 JP JP2006000572A patent/JP4526487B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
US5716660A (en) | 1998-02-10 |
DK0698395T3 (da) | 2002-07-01 |
FI952218A (fi) | 1996-02-13 |
JPH0866468A (ja) | 1996-03-12 |
CA2147565C (en) | 2008-02-26 |
JP2004136093A (ja) | 2004-05-13 |
CA2147565A1 (en) | 1996-02-13 |
AU688470B2 (en) | 1998-03-12 |
JP3563498B2 (ja) | 2004-09-08 |
EP0698395A1 (en) | 1996-02-28 |
DE69525692D1 (de) | 2002-04-11 |
JP4526487B2 (ja) | 2010-08-18 |
AU1772395A (en) | 1996-02-22 |
DE69525692T2 (de) | 2002-10-31 |
EP0698395B2 (en) | 2007-06-06 |
EP0698395B1 (en) | 2002-03-06 |
ES2173939T3 (es) | 2002-11-01 |
DE69525692T3 (de) | 2007-10-18 |
US5665114A (en) | 1997-09-09 |
FI952218A0 (fi) | 1995-05-08 |
JP2006102533A (ja) | 2006-04-20 |
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