JP2018020104A - 吻合の部位における狭窄の予防のための装置および方法 - Google Patents
吻合の部位における狭窄の予防のための装置および方法 Download PDFInfo
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Abstract
Description
本願は、2010年1月27日に出願された米国仮特許出願第61/298,631号への優先権を主張する。
本発明は一般的に、吻合の部位およびその周囲における狭窄を予防、抑制または処置するために有用な治療移植片、装置および方法に関する。加えて本発明は、吻合またはフィステルへの配置のために特定的に構成されたステント、ならびにそれらの部位をマトリックス材料および治療剤を含む血管外治療移植片と組み合わせるための方法にも関する。この特定的に構成されたステントは、吻合から離れた狭窄または狭小化の処置にも有用であり、たとえば側枝における小孔狭窄の処置、中心静脈(例、橈側皮アーチ(cephalic arch))における狭窄の処置などにも有用である。
方法:ヒツジモデルを用いて原理研究の証明を行った。6mmのPTFE血管グラフトを、一方側の頸動脈と反対側の頸静脈との間で吻合し、ヒトの血液透析アクセスループと類似の構成の動脈静脈(AV)ループグラフトを作製した。合計4匹の動物の研究を行い、2匹の動物(2つのAVグラフト)はPTFEグラフト−静脈吻合に血管内自己拡張型ニチノールステントを受け取り、他方の2匹の動物(2つのAVグラフト)はPTFE−静脈グラフト吻合に血管内自己拡張型ニチノールステントと、血管周囲シロリムス(ラパマイシン)溶出コラーゲンマトリックスとを受け取った。シロリムス溶出コラーゲンマトリックスはPTFEグラフト静脈吻合の場所の外表面に移植されることによって、外部面のマトリックスが血管内のニチノール血管内ステントの場所にほぼ対応するようにされた。使用されたステントは自己拡張型ニチノールステントであり、長さは30mm、完全に拡張されたときの直径は8.0mmであった。コラーゲンマトリックスは既知用量のシロリムス(およそ75マイクログラム/cm2)と組み合わされた。
結論:
1.狭小化の程度(%ステント直径狭窄)は、ステントおよび薬物溶出性ステントマトリックスの両方を受け取った動物よりも、薬物溶出コラーゲンマトリックスを伴わずにステントを受け取った動物の方が高い。
方法:ヒツジ動脈−静脈フィステルモデルを用いて原理研究の証明を行った。大腿静脈を大腿動脈に、(静脈の)端部から(動脈の)側部への様式で吻合することによって、両側性の動脈静脈フィステルを作製した。吻合の方法(端部から側部)は、ヒトにおいて透析アクセスを提供するために作製されるAVフィステルの構成(例、橈骨−橈側皮(radio−cephalic)、上腕−橈側皮)を模倣するものである。血管内ステントに加えて血管周囲の薬物溶出(例、シロリムス)を用いるという概念は、他の吻合構成(例、端部から端部、側部から側部など)、および静脈と動脈とが吻合されるその他の手術(例、冠状動脈バイパスグラフト手術、末梢血管バイパス手術)または2本の導管が吻合されるその他の手術(例、卵管、尿管、胆管、気管支気道、腸係蹄など)にも適用可能である。対照フィステルは、血管内自己拡張型ニチノールステントも血管周囲シロリムス(ラパマイシン)溶出コラーゲンマトリックスも受け取らなかった。処置フィステルは、吻合から始まって流出静脈に延在する(この場合は吻合近傍セグメントにわたる)血管内自己拡張型ニチノールステントと、血管周囲シロリムス(ラパマイシン)溶出コラーゲンマトリックスとを受け取った。シロリムス溶出コラーゲンマトリックスはフィステルの外表面に移植されることによって、外部面のマトリックスが血管内のニチノール血管内ステントの吻合場所にほぼ対応するようにされた。加えてシロリムス溶出マトリックスは、マトリックスが吻合の場所の動脈と静脈との両方を包むように吻合に移植された。下に考察される例示的実施例は、長さが30mmまたは40mmで完全に拡張されたときの直径が6mmである自己拡張型ステントの使用を示す。コラーゲンマトリックスは既知用量のシロリムス(およそ75マイクログラム/cm2)と組み合わされた。
1.対照動物(血管内ステントも血管周囲シロリムス溶出コラーゲンマトリックスも無)における動脈−静脈フィステルの28日後の血管造影図は、吻合および流出静脈の吻合近傍セグメントにおける重篤な狭窄を示す。この狭窄のパターンは、ヒトにおける状況(例、透析を支持するために作製された橈骨−橈側皮フィステルにおける狭窄、冠状動脈および末梢動脈バイパスグラフト手術における静脈グラフトの吻合狭窄)を模倣している。
Claims (18)
- 血管吻合部位における狭窄を予防するための、抗血管増殖薬を吸収させた生細胞及び粘着性の両方がない生体適合性マトリックス材料であって、
血管の内腔内に配置された薬物のないステントと組み合わせて用いられ、
前記血管の血管外表面に適用されたスリーブに形成される、生体適合性マトリックス材料。 - 前記血管吻合部位は、動脈、静脈又はグラフトの一部である、請求項1に記載の生体適合性マトリックス材料。
- 前記ステントは自己拡張型ステントである、請求項1に記載の生体適合性マトリックス材料。
- 前記ステントはバルーン拡張可能型ステントである、請求項1に記載の生体適合性マトリックス材料。
- 前記ステントはベアメタルのステントである、請求項1に記載の生体適合性マトリックス材料。
- 前記ステントは、ポリマー又は織物によって部分的に又は完全に覆われている、請求項1に記載の生体適合性マトリックス材料。
- 前記ステントは、PTFEにより覆われている、請求項6に記載の生体適合性マトリックス材料。
- 前記マトリックス材料は、コラーゲン、フィブリン、多糖、およびそれらの混合物からなる群より選択される、請求項1に記載の生体適合性マトリックス材料。
- 前記多糖はキトサンである、請求項8に記載の生体適合性マトリックス材料。
- 前記マトリックス材料はコラーゲンを含む、請求項8に記載の生体適合性マトリックス材料。
- 前記コラーゲンは、I型、II型、III型、IV型、XI型、およびそれらの混合物からなる群より選択される、請求項10に記載の生体適合性マトリックス材料。
- 前記コラーゲンはI型ウシコラーゲンである、請求項11に記載の生体適合性マトリックス材料。
- 前記ステントは吻合部位に配置するために長手軸に沿って湾曲している、請求項8に記載の生体適合性マトリックス材料。
- 前記マトリックス材料に吸収された前記抗血管増殖薬はラパマイシンである、請求項1に記載の生体適合性マトリックス材料。
- 前記マトリックス材料に吸収された前記抗血管増殖薬はラパマイシンのアナログである、請求項1に記載の生体適合性マトリックス材料。
- 前記ラパマイシンの前記アナログはエベロリムス又はゾタロリムスである、請求項15に記載の生体適合性マトリックス材料。
- 前記生体適合性マトリックス材料に吸収された有効成分は、抗血管増殖薬のみからなる、請求項1に記載の生体適合性マトリックス材料。
- 前記マトリックス材料に吸収された前記抗血管増殖薬は、ラパマイシン又はラパマイシンのアナログである、請求項17に記載の生体適合性マトリックス材料。
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Also Published As
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EP2528537A4 (en) | 2016-09-07 |
WO2011094459A1 (en) | 2011-08-04 |
US20110319976A1 (en) | 2011-12-29 |
EP2528537A1 (en) | 2012-12-05 |
US20140088681A1 (en) | 2014-03-27 |
US20170020651A1 (en) | 2017-01-26 |
JP6172704B2 (ja) | 2017-08-02 |
US20200360126A1 (en) | 2020-11-19 |
JP2013517906A (ja) | 2013-05-20 |
JP6506350B2 (ja) | 2019-04-24 |
JP2019150584A (ja) | 2019-09-12 |
EP3878403A1 (en) | 2021-09-15 |
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