JP2013514093A - 止血スポンジ - Google Patents
止血スポンジ Download PDFInfo
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- JP2013514093A JP2013514093A JP2012543413A JP2012543413A JP2013514093A JP 2013514093 A JP2013514093 A JP 2013514093A JP 2012543413 A JP2012543413 A JP 2012543413A JP 2012543413 A JP2012543413 A JP 2012543413A JP 2013514093 A JP2013514093 A JP 2013514093A
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- sponge
- collagen
- hemostatic
- tissue
- adhesion
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- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
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- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
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- C08G65/02—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule from cyclic ethers by opening of the heterocyclic ring
- C08G65/32—Polymers modified by chemical after-treatment
- C08G65/329—Polymers modified by chemical after-treatment with organic compounds
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- C09J—ADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES
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Abstract
Description
a)生体材料のマトリックスの多孔質スポンジを用意する工程、
b)適用組織に対する該スポンジの付着性を増強する材料を懸濁物、溶液又は粉体の形態で用意する工程であって、ここで該材料はヒドロゲル形成成分を本質的に含まない工程、
c)止血性複合スポンジが得られるように、b)の材料が該スポンジの少なくとも1つの表面と安定に結合するように、a)とb)を接触させる工程、必要に応じて
d)工程c)で得られた複合スポンジを乾燥させる工程、必要に応じて
e)工程c)又はd)で得られた該複合スポンジを滅菌する工程
を含む、止血性多孔質スポンジを製造する方法に関する。
a)生体材料のマトリックスを含むスポンジを用意する工程、
b)適用組織に対する該スポンジの付着性を増強する材料を懸濁物、溶液又は粉体の形態で用意する工程、
c)b)の材料が該スポンジの少なくとも1つの表面に存在するようにa)とb)を接触させる工程、及び必要に応じて
d)工程c)で得られたスポンジを乾燥させる工程
を含む、止血性多孔質スポンジを製造する方法に関する。
COH206 ペンタエリスリトールポリ(エチレングリコール)エーテルテトラチオール
EtOH エタノール
PEG ポリエチレングリコール
PET ポリエチレンテレフタラート
2種類の反応性PEGの酸性溶液で処理されたコラーゲンスポンジ
PEG濃度(COH102とCOH206 1:1)が10mg/cm3、35mg/cm3、70mg/cm3及び100mg/cm3のCOH102とCOH206の水性の酸性溶液(pH3.0、HCl)を調製し、9×7cm PETトレイに充填する。先に充填したPEG溶液と同じ体積の9×7cmの市販ウシコラーゲンスポンジ(Matristypt(登録商標))を溶液の上に置く。PEG溶液の吸収後、コラーゲン材料を凍結乾燥させる。
2種類の反応性PEGのEtOH溶液で処理されたコラーゲンスポンジ
COH102及びCOH206を、完全に乾燥させたEtOHに溶解させる。10mg/cm3、35mg/cm3、70mg/cm3及び100mg/cm3のPEG濃度(COH102とCOH206 1:1)を調製し、溶液を9×7cm PETトレイに充填する。先に充填したPEG溶液と同じ体積の9×7cmの市販ウシコラーゲンスポンジ(Matristypt(登録商標))を溶液の上に置く。PEG溶液の吸収後、コラーゲン材料を真空室で乾燥させる。
コラーゲン/反応性PEG構築物の調製
種々の濃度(2.15mg/cm3、4.3mg/cm3及び7.2mg/cm3)のウシ真皮コラーゲンを含み、PEG(COH102とCOH206 1:1)濃度が7.2mg/cm3、14.3mg/cm3、28.6mg/cm3及び57.3mg/cm3の水性の酸性溶液(pH3.0、HCl)22mlを調製し、PETトレイに充填し、凍結乾燥させる。
2層コラーゲン/反応性PEG構築物の調製
実施例3に記載のような酸性コラーゲン/PEG溶液(pH3.0、HCl)11ml及び22mlをPETトレイに充填し、−20℃ですぐに凍結させる。氷相の上に1%ウシ真皮コラーゲン溶液pH3.0(HCl)11ml又は22mlを塗布し、得られた構築物を凍結乾燥させる。
反応性PEGによるコラーゲンスポンジの均一コーティング
COH102とCOH206の1:1粉体混合物を、市販コラーゲンスポンジの一表面に、又は実施例1、2、3及び4に記載のような方法の一つの後に調製されたスポンジ上に、均一に散布する。2mg/cm2、7mg/cm2、10mg/cm2、14mg/cm2及び20mg/cm2のPEG量をコーティングのために使用する。PEG粉体混合物は、例えば、PEG粉体混合物を含むスポンジを60から65℃の予熱オーブンに4分間入れるなどして融解することによって、スポンジ表面に固定される。
反応性PEGによるコラーゲンスポンジの不連続コーティング
パッド表面が部分的に遮蔽され、PEG粉体で部分的に覆われないように、コーティング前に格子をコラーゲンスポンジ表面に置くことを除いては、実施例5に記載のようにパッドを調製する。メッシュサイズ5mm及び10mmの格子マトリックスを使用し、粉体散布後に除去する。粉体の固定、パッケージング及び滅菌は実施例5に記載のとおりである。
架橋PEGによるコラーゲン構築物の調製
a)ウシコラーゲンスポンジ上に反応性PEG COH102とCOH206(1:1)を、二重シリンジとガス駆動スプレーヘッドで構成される市販噴霧アプリケーター(Duplospray、Baxter)を使用して噴霧する。一方のシリンジはpH3.0のCOH102とCOH206を含み、第2のシリンジはpH9.4の緩衝剤を含む。2つのPEG成分の重合は、沈積直後にコラーゲン表面で起こる。スポンジは、真空室で乾燥させることができる。
反応性PEGによるキトサン/ゼラチンスポンジの連続コーティング
COH102とCOH206の1:1粉体混合物を市販キトサン/ゼラチン(Chitoskin(登録商標)、Beese Medical)スポンジの一表面に均一に散布する。14mg/cm2のPEG量をコーティングに使用する。PEG粉体混合物は、例えば、PEG粉体混合物を含むスポンジを60から65℃の予熱オーブンに4分間入れるなどして融解することによって、スポンジ表面に固定される。
反応性PEGによる酸化セルロース織物のコーティング
COH102とCOH206の1:1粉体混合物を市販酸化セルロース織物(Traumstem(登録商標)、Bioster)の一表面に均一に散布する。14mg/cm2のPEG量をコーティングに使用する。PEG粉体混合物は、例えば、PEG粉体混合物を含むスポンジを60から65℃の予熱オーブンに4分間入れるなどして融解することによって、スポンジ表面に固定される。
前臨床応用
上記実施例によって調製したスポンジを、肝臓擦過モデルのヘパリン処置ブタ(1.5倍ACT)において試験する。回転研磨機を用いて直径1.8cmの出血した環状の傷を肝葉表面に作る。3×3cmスポンジを適用し、食塩水緩衝剤を吸わせたガーゼ小片と一緒に傷に対して2分間軽く押しつける。ガーゼ除去後、図1から4に示すように良好な止血性能が得られる。
Claims (10)
- 止血性複合スポンジであって、該スポンジは、
生体材料のマトリックスの多孔質スポンジと、
該スポンジの少なくとも1つの表面と安定に結合する、適用組織に対する該スポンジの付着性を増強する材料と
を含み、ここで、該材料がヒドロゲル形成成分を本質的に含まない、止血性複合スポンジ。 - 前記生体材料が、コラーゲン、ゼラチン、フィブリン、多糖、例えばキトサン、及びその誘導体からなる群から選択される、請求項1に記載のスポンジ。
- 前記適用組織に対する前記スポンジの付着性を増強する前記材料が、第1の架橋可能成分と、反応可能な条件下で該第1の架橋可能成分と架橋する第2の架橋可能成分とを含む、2種類のプレポリマーの混合物、又は前もって形成されたポリマーである、請求項1又は2に記載のスポンジ。
- 前記第1及び/又は第2の架橋可能成分が、ポリエチレングリコールの誘導体を含む、請求項1から3のいずれか一項に記載のスポンジ。
- 前記適用組織に対する前記スポンジの付着性を増強する前記材料が、該スポンジの少なくとも1つの表面に連続又は不連続な層を形成する、請求項1から4のいずれか一項に記載のスポンジ。
- 全厚が約1mmから約2.5mmである、請求項1から5のいずれか一項に記載のスポンジ。
- 低侵襲手術において、例えば腹腔鏡検査適用に使用するための、請求項1から6のいずれか一項に記載のスポンジ。
- 前記適用組織に対する前記スポンジの付着性を増強する前記材料が、生体材料1cm2当たり5から500mg、好ましくは1cm2当たり5から100mgの濃度で存在する、請求項1から7のいずれか一項に記載のスポンジ。
- 止血性複合スポンジを製造する方法であって、
a)生体材料のマトリックスの多孔質スポンジを用意する工程、
b)適用組織に対する該スポンジの付着性を増強する材料を懸濁物、溶液又は粉体の形態で用意する工程であって、ここで該材料はヒドロゲル形成成分を本質的に含まない工程、
c)止血性複合スポンジが得られるように、b)の該材料が該スポンジの少なくとも1つの表面と安定に結合するように、a)とb)を接触させる工程、必要に応じて
d)工程c)で得られた該複合スポンジを乾燥させる工程、必要に応じて
e)工程c)又はd)で得られた該複合スポンジを滅菌する工程
を含む、方法。 - 請求項1から7のいずれか一項に記載の止血性複合スポンジを施す工程を含む、創傷、出血、損傷組織及び/又は出血組織を処置する方法。
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BR112012014773A2 (pt) | 2015-11-03 |
KR101811070B1 (ko) | 2017-12-20 |
US20140378928A1 (en) | 2014-12-25 |
CA2784432A1 (en) | 2011-07-07 |
CA2784432C (en) | 2019-01-15 |
US11071804B2 (en) | 2021-07-27 |
EP2512535A1 (en) | 2012-10-24 |
US8771258B2 (en) | 2014-07-08 |
AU2010339045B2 (en) | 2014-06-05 |
AU2010339045A1 (en) | 2012-07-12 |
US20180104377A1 (en) | 2018-04-19 |
US9872934B2 (en) | 2018-01-23 |
KR20120116961A (ko) | 2012-10-23 |
US20210228764A1 (en) | 2021-07-29 |
MX2012007056A (es) | 2012-09-28 |
WO2011079336A1 (en) | 2011-07-07 |
US9517287B2 (en) | 2016-12-13 |
US20110202026A1 (en) | 2011-08-18 |
CN102753203A (zh) | 2012-10-24 |
US20170080119A1 (en) | 2017-03-23 |
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