JPWO2017057389A1 - 医療用長尺体 - Google Patents
医療用長尺体 Download PDFInfo
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- JPWO2017057389A1 JPWO2017057389A1 JP2017543445A JP2017543445A JPWO2017057389A1 JP WO2017057389 A1 JPWO2017057389 A1 JP WO2017057389A1 JP 2017543445 A JP2017543445 A JP 2017543445A JP 2017543445 A JP2017543445 A JP 2017543445A JP WO2017057389 A1 JPWO2017057389 A1 JP WO2017057389A1
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- temperature
- coating layer
- lubricating coating
- responsive
- end side
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- C08L35/08—Copolymers with vinyl ethers
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Abstract
【解決手段】シースチューブ110の外表面には、湿潤時に潤滑性を示す親水性潤滑被覆層160と、湿潤時に臨界温度未満で親水性及び潤滑性を示し、かつ、湿潤時に臨界温度以上で疎水性及び非潤滑性を示す温度応答性潤滑被覆層170と、が形成されており、温度応答性潤滑被覆層は、親水性潤滑被覆層の基端側に配置されており、かつ、シースチューブの基端側に形成されている。
【選択図】図2
Description
アジピン酸2塩化物72.3g中に50℃でトリエチレングリコール29.7gを滴下した後、50℃で3時間、塩酸を減圧除去して、オリゴエステルを得た。続いて、得られたオリゴエステル22.5gにメチルエチルケトン4.5gを加え、これを水酸化ナトリウム5g、31%過酸化水素6.93g、界面活性剤としてのジオクチルホスフェート0.44gおよび水120gよりなる溶液中に滴下し、−5℃で20分間反応させた。得られた生成物は、水洗、メタノール洗浄を繰り返した後、乾燥させて、分子内に複数のパーオキサイド基を有するポリ過酸化物(PPO)を得た。続いて、このPPOを重合開始剤として0.5g、グリシジルメタクリレート(GMA)9.5gを、ベンゼンを溶媒として、65℃2時間、減圧下で撹拌しながら重合した。反応物は、ジエチルエーテルで再沈殿して、分子内にパーオキサイド基を有するポリGMA(PPO−GMA)を得た。
上記調製例1と同様にして、ポリGMA(PPO−GMA)を合成した。続いて、得られたPPO−GMA1.43gを重合開始剤として、親水性モノマーであるN、N−ジメチルアクリルアミド(DMAAm)20.0gと共にクロロベンゼン中に溶解し、窒素雰囲気下で8時間、75℃に加温することにより重合した。反応物はヘキサンで再沈殿して回収し、親水性部位としてDMAAm部位と、反応性官能基を有する疎水性部位としてGMA部位とを有するブロック共重合体2を作製した。作製したブロック共重合体2のDMAAm:GMA比率(すなわち、ブロック共重合体中の親水性部位と疎水性部位のモル比)は20:1(モル比)であった。
130mmの長さを有するエチレン4フッ化エチレン(ETFE;Ethylene Tetra Fluoro Ethylene)製シース(5Fr)を準備し、準備したシースに大気圧下でプラズマ処理を施し、先端側100mm長を、上記調製例2で得られた親水性ポリマーコート液にディップコートした。その後、後端(基端)側30mm長を、上記調製例1で得られた温度応答性ポリマーコート液にディップコートした。そして、シース全体を150℃で2時間加熱することにより、後端30mmに温度応答性ポリマーがコートされたシースを得た。さらに、シースの最後端部位には30℃未満で青色、30℃以上で赤色を呈する印刷体(パイロットインキ株式会社製、メタモラベル)を温度インジケータとして添付し、温度状態を視覚的に判別可能にした(実施例1)。
1.挿入性
上記実施例1および比較例1〜2にて作製したシースを、それぞれ、室温(25℃)の生理食塩水に浸した後、37℃の恒温槽中に設置したシリコーン製動脈モデルに速やかに穿刺し、シース最後端部付近まで挿入して留置した。実施例1のシースの温度インジケータはこの間青色を呈し、大きな抵抗を感じることなくモデルに挿入することが可能であった。全長が親水性ポリマーコートされた比較例1のシースも、同様に抵抗感なくモデルに挿入することが可能であった。一方、未コートの比較例2のシースは、モデル挿入時の抵抗が大きく、挿入しにくかった。
動脈モデル留置中のシースの抜けやすさを評価するため、上記37℃の恒温槽中に設置したシリコーン製動脈モデルに留置したシースの最後端をプッシュプルゲージに接続し、5mm/secの速度でシースを引き抜いた際の抵抗値を測定した。実施例1のシースの温度インジケータはモデル留置後に赤色を呈し、温度応答性ポリマーの臨界温度(LCST)以上となっていることが確認できた。その状態での実施例1のシースの引き抜き抵抗は203.3gfであり、容易に抜け出さない抵抗値であった。一方、全長に親水性ポリマーコートが施された比較例1は、21.7gfの引き抜き抵抗を示し、僅かな力により意図せずシースが抜け出す可能性があった。
動脈モデルに留置した実施例1のシース留置部付近に、25℃の生理食塩水を含ませたガーゼを押し当て、実施例1のシースの温度インジケータが青色を呈するまで温度を低下させた。その状態で留置したシースの最後端をプッシュプルゲージに接続し、5mm/secの速度でシースを引き抜いた際の抵抗値を測定した。実施例1のシースの引き抜き抵抗は22.3gfを示し、温度を意図的に低下させることで、親水性ポリマーコート同様の小さい引き抜き抵抗で抜去できることが示された。
100 イントロデューサーシース(医療用長尺体)、
110 シースチューブ(チューブ状本体)、
115 中空部、
117 マーカー、
120 シースハブ、
130 ストレインリリーフ、
131a ストレインリリーフの先端、
160 親水性潤滑被覆層、
170 温度応答性潤滑被覆層、
200 ダイレーター。
Claims (9)
- 軸方向に延在する中空部を備えるチューブ状本体と、
前記チューブ状本体の基端側に接続されたハブと、
前記ハブの先端側に支持され、前記チューブ状本体の基端側の所定範囲を囲むストレインリリーフと、を備え、
前記チューブ状本体の外表面には、
湿潤時に潤滑性を示す親水性潤滑被覆層と、
湿潤時に臨界温度未満で親水性及び潤滑性を示し、かつ、湿潤時に臨界温度以上で疎水性及び非潤滑性を示す温度応答性潤滑被覆層と、が形成されており、
前記温度応答性潤滑被覆層は、前記親水性潤滑被覆層の基端側に配置されており、かつ、前記チューブ状本体の基端側に形成されている、ことを特徴とする医療用長尺体。 - 前記親水性潤滑被覆層は、前記チューブ状本体の全長の半分以上にわたって形成されている、ことを特徴とする請求項1に記載の医療用長尺体。
- 前記温度応答性潤滑被覆層は、前記ストレインリリーフの先端よりも先端側から前記ストレインリリーフの先端よりも基端側までの所定範囲にわたって、前記チューブ状本体の外表面に形成されている、ことを特徴とする請求項1または請求項2に記載の医療用長尺体。
- 前記温度応答性潤滑被覆層の臨界温度は25℃以上35℃以下の範囲にある、ことを特徴とする請求項1〜3のいずれか1項に記載の医療用長尺体。
- 前記温度応答性潤滑被覆層の少なくとも一部は、前記親水性潤滑被覆層と接触している、ことを特徴とする請求項1〜4のいずれか1項に記載の医療用長尺体。
- 前記温度応答性潤滑被覆層の少なくとも一部は、前記親水性潤滑被覆層を覆っている、ことを特徴とする請求項5に記載の医療用長尺体。
- 前記親水性潤滑被覆層の少なくとも一部は、前記温度応答性潤滑被覆層を覆っている、ことを特徴とする請求項5に記載の医療用長尺体。
- 前記チューブ状本体の基端側には、マーカーが形成されており、
前記温度応答性潤滑被覆層の先端は、前記マーカーと重なる位置、又は前記マーカーよりも先端側の位置に配置されている、ことを特徴とする請求項1〜7のいずれか1項に記載の医療用長尺体。 - 前記チューブ状本体および/または前記温度応答性潤滑被覆層には、前記温度応答性潤滑被覆層が形成された位置を識別させるための色素が含まれている、ことを特徴とする請求項1〜8のいずれか1項に記載の医療用長尺体。
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JPH04144567A (ja) * | 1990-10-04 | 1992-05-19 | Terumo Corp | 医療用具 |
JPH0724056A (ja) * | 1993-07-06 | 1995-01-27 | Olympus Optical Co Ltd | 生体内留置具 |
JP2001224695A (ja) * | 2000-02-16 | 2001-08-21 | Kawasumi Lab Inc | 潤滑性シース及びシースダイレータ |
JP2002136600A (ja) * | 2000-10-30 | 2002-05-14 | Terumo Corp | 医療用長尺体およびその製造方法 |
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