JP2013526369A - 止血用途のための強化された吸収性多層布 - Google Patents
止血用途のための強化された吸収性多層布 Download PDFInfo
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- D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
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Abstract
Description
ポリ(グリコリド−コ−ラクチド)(PGLA、90/10モル/モル)を溶融紡糸してPGLAコポリマー繊維にした。このPGLAコポリマー繊維の多フィラメント糸を統合し、けん縮し、5.08cm(2.0インチ)の長さを有する短繊維にした。この短繊維材を毛羽立てて不織芯を作り、厚さ約1.0mm及び密度約60mg/ccに圧縮する。第2不織芯を同様の手順により作製し、次いで厚さ約1.0mm及び密度約120mg/ccに圧縮する。次いで、60mg/ccの密度を有するものと120mg/ccの密度を有するものとの2つの不織布を互いにニードルパンチして、不織布二層マトリックスを固定する。
ブタの脾臓に長さ15mm、深さ3mmの切り込みを入れることにより、軽度から中程度の出血モデルを作製する。実施例1で説明したような二層マトリックスをその外科的部位に適用し、タンポナーデを2分間適用した。2分間のタンポナーデの後、止血を30秒間観察した。自由に流れる出血が30秒以内に観察されない場合、止血までの時間を記録する。自由に流れる出血が観察された場合、止血が達成されるまで又は、試験時間が10分間に達する(これは止血の失敗として定義される)まで、30秒タンポナーデを再び適用する。2.5×4.0センチメートルの寸法に切断した実施例1で調製した二層マトリックスの3つの試料片は5.62±0.76分(表1)で止血を達成した。
実施例1にしたがって調製した二層マトリックスの機械的特性を試験管内試験で特徴付ける。二層マトリックスを切断して片(幅約0.95cm(3/8インチ)、長さ5.08cm(2インチ))を作る。Instron Tensile Analyzerを用いて、乾燥条件及び濡れ条件で二層マトリックスの引張り強度を評価する。濡れ条件で、pH 7.4の37℃のPBS緩衝液を含有する円錐管に片を入れる。次いで、片の引張り強度を90分、4日、7日、11日、及び14日で測定する。二層マトリックスの片の引張り強度の測定値を表2に示す。
(1) ポリグリコリド/ポリラクチドコポリマーの第1吸収性短繊維とポリグリコリド/ポリラクチドコポリマーの第2吸収性短繊維との少なくとも2つの層を有する不織マトリックスを備える合成布であり、前記第1吸収性布は約60mg/ccの密度に圧縮され、前記第2吸収性布は約120mg/ccの密度に圧縮される、合成布。
(2) 前記第1吸収性布及び前記第2吸収性布が90/10モル/モル配合のグリコリド/ラクチドのコポリマーからなる、実施態様1に記載の合成布。
(3) 前記第1吸収性布及び前記第2吸収性布が約1.91〜6.35cm(0.75〜2.5インチ)の長さを有する短繊維を含む、実施態様1に記載の合成布。
(4) 前記短繊維がけん縮される、実施態様3に記載の合成布。
(5) 前記第1吸収性布が約0.5mm〜約1.5mm、より好ましくは約1mmの厚さに圧縮される、実施態様4に記載の合成布。
(6) 前記第2吸収性布が約0.75mm〜約3mm、より好ましくは約1mmの厚さに圧縮される、実施態様5に記載の合成布。
(7) 前記第1吸収性布1枚と前記第2吸収性シート1枚とが互いにニードルパンチされる、実施態様5に記載の合成布。
(8) 前記布が少なくとも1つの止血剤を更に含む、実施態様7に記載の合成布。
(9) 前記布が前記止血剤としてフィブリノゲン及びトロンビンを更に含む、実施態様8に記載の合成布。
(10) 前記フィブリノゲン及びトロンビンが凍結乾燥された粉末として前記布に提供される、実施態様9に記載の合成布。
(12) 実施態様11に記載の合成布を医療用装置として使用する方法。
(13) 止血を要する創傷に適用されたときに前記医療用装置が効果的な止血をもたらし、かつ維持する、実施態様12に記載の方法。
(14) 前記装置が軽度から中程度の出血を約1〜約10分間の有効時間内に制御し、弱める、実施態様12に記載の方法。
(15) 幅約0.95cm(3/8インチ)から長さ約5.08cm(2インチ)までの片が、Instron Tensile Analyzerで測定されたときに、
a.乾燥条件で約120、
b.濡れ条件90分間で約115、
c.濡れ条件4日間で約90、
d.濡れ条件7日間で約52、
e.濡れ条件11日間で約29、
f.濡れ条件14日間で約16、
の測定引張り強度(ニュートン/cm)を有する、実施態様1に記載の合成布。
Claims (12)
- ポリグリコリド/ポリラクチドコポリマーの第1吸収性短繊維とポリグリコリド/ポリラクチドコポリマーの第2吸収性短繊維との少なくとも2つの層を有する不織マトリックスを備える合成布であり、前記第1吸収性布は約60mg/ccの密度に圧縮され、前記第2吸収性布は約120mg/ccの密度に圧縮される、合成布。
- 前記第1吸収性布及び前記第2吸収性布が90/10モル/モル配合のグリコリド/ラクチドのコポリマーからなる、請求項1に記載の合成布。
- 前記第1吸収性布及び前記第2吸収性布が約1.91〜6.35cm(0.75〜2.5インチ)の長さを有する短繊維を含む、請求項1に記載の合成布。
- 前記短繊維がけん縮される、請求項3に記載の合成布。
- 前記第1吸収性布が約0.5mm〜約1.5mm、より好ましくは約1mmの厚さに圧縮される、請求項4に記載の合成布。
- 前記第2吸収性布が約0.75mm〜約3mm、より好ましくは約1mmの厚さに圧縮される、請求項5に記載の合成布。
- 前記第1吸収性布1枚と前記第2吸収性シート1枚とが互いにニードルパンチされる、請求項5に記載の合成布。
- 前記布が少なくとも1つの止血剤を更に含む、請求項7に記載の合成布。
- 前記布が前記止血剤としてフィブリノゲン及びトロンビンを更に含む、請求項8に記載の合成布。
- 前記フィブリノゲン及びトロンビンが凍結乾燥された粉末として前記布に提供される、請求項9に記載の合成布。
- 前記第1層の外面から前記第2層の外面まで測定されたときに、前記凍結乾燥された粉末が不均等に分散されている、請求項10に記載の合成布。
- 幅約0.95cm(3/8インチ)から長さ約5.08cm(2インチ)までの片が、Instron Tensile Analyzerで測定されたときに、
a.乾燥条件で約120、
b.濡れ条件90分間で約115、
c.濡れ条件4日間で約90、
d.濡れ条件7日間で約52、
e.濡れ条件11日間で約29、
f.濡れ条件14日間で約16、
の測定引張り強度(ニュートン/cm)を有する、請求項1に記載の合成布。
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US12/781,235 US8329211B2 (en) | 2010-05-17 | 2010-05-17 | Reinforced absorbable multi-layered fabric for hemostatic applications |
US12/781,235 | 2010-05-17 | ||
PCT/US2011/036591 WO2011146360A1 (en) | 2010-05-17 | 2011-05-16 | Reinforced absorbable multi-layered fabric for hemostatic applications |
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US8329211B2 (en) | 2012-12-11 |
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