JP5599886B2 - 生物再吸収性不貫通性層で被覆された保持織物 - Google Patents
生物再吸収性不貫通性層で被覆された保持織物 Download PDFInfo
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- JP5599886B2 JP5599886B2 JP2012527350A JP2012527350A JP5599886B2 JP 5599886 B2 JP5599886 B2 JP 5599886B2 JP 2012527350 A JP2012527350 A JP 2012527350A JP 2012527350 A JP2012527350 A JP 2012527350A JP 5599886 B2 JP5599886 B2 JP 5599886B2
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Images
Classifications
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
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- A61F2220/0008—Fixation appliances for connecting prostheses to the body
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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Landscapes
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Description
−a)少なくとも1つの生物再吸収性物質を含む溶液を準備すること;
−b)溶液の層を不活性支持体に適用すること;および
−c)層が少なくとも部分的にゲル化したときに、織物の第2の面が層に対して適用されること;および
−i)少なくとも1つの水溶性生体適合性物質を液体状態で含む組成物を準備すること;および
−ii)組成物の層を鉤状突起に対して適用すること;
ここにおいて、工程i)およびii)は、工程a)〜c)に対して何れかの順番で実行される。
−a)少なくとも1つの生物再吸収性物質および少なくとも1つの生物活性剤を含む溶液を準備すること;
−b)溶液の層を不活性支持体に対して適用すること;および
−c)層が少なくとも部分的にゲル化したときに、織物の第2の面を層に対して適用すること。
−i)少なくとも1つの水溶性生体適合性物質を液体状態で含む組成物を準備すること;および
−ii)組成物の層を鉤状突起に対して適用すること。
−i)液体状態にある少なくとも1つの水溶性生体適合性物質を含む組成物を調製すること;および
−ii)鉤状突起に対して組成物の層を適用すること。
WO01/81667に記述されるように15×10cm2のサイズを有し、かつ鉤状突起を含むプロステーシス織物を準備する。鉤状突起をポリ乳酸 (PLA)から作られるモノフィラメントヤーンから製造する。
1)微小多孔層を形成するための生物再吸収性物質の溶液の調製;
使用されるコラーゲンは、I型ブタコラーゲンであり、酸性pHでの可溶化またはペプシン消化によりブタ皮膚から抽出され、公知の技術に従って生理食塩水沈殿によって精製される。
1)で得られた溶液の一部をPVCまたはポリスチレンから作られた平坦な疎水性不活性支持体上に0.095g/cm2の密度を持つ第1の薄層を形成するように展開する。
生物活性剤を例1A1)で調製される溶液に対して添加したことを除いて、被覆されたプロステーシス織物を、前記例1Aと同様な手法で製造する。
例1Aのプロステーシス織物の鉤状突起の水溶性物質での被覆:
例1Aで得られるようなプロステーシス織物を包装する前に準備する。織物の鉤状突起を水溶性物質から作られるコーティング剤で例えば次の方法に従って被覆する。
例1Bのプロステーシス織物の鉤状突起の水溶性物質での被覆:
プロステーシスを包装する前に、例1Bのプロステーシス織物の鉤状突起を例1Cに記述されるのと同様な様式において水溶性物質で被覆する。
上記の例1Aおよび図1に示されるものと同様な初期プロステーシス織物を準備する。
PEG4000(4000ダルトンのモル質量を有するポリエチレングリコール、例えばFlukaからのPEG4000の商品名下で市販される)の滅菌濃溶液およびグリセロール(Flukaにより市販される)を3%w/vの濃度でゼラチン溶液(酸加水分解またはアルカリ加水分解により得られる、例えば、シグマから市販される)に添加し、それにより1%w/vの最終濃度のPEG4000および0.6%w/vの最終濃度のグリセロールを含む混合物を得る。溶液のpHを濃水酸化ナトリウム溶液の添加により7.0に調整する。次いで、溶液の量は、それぞれ2.7%w/v、0.9%w/vおよび0.54%w/vのゼラチン、PEG4000およびグリセロールの最終濃度を得るように滅菌水を添加して調節される。
1)で得られた溶液を、PVCまたはポリスチレンから作られた平坦な疎水性不活性支持体上に0.133g/cm2の密度を有する薄層を形成するように展開する。表面を次いで1)で得られた溶液をゲルにするために、周囲温度で、5〜60分間に亘って滅菌空気流に曝す。プロステーシス織物の第2の面2bを次いで前記溶液のゲル層に対してゆっくりと適用する。全体のアセンブリを周囲温度で、完全な蒸発が達成されるまで、約18時間、滅菌空気流に曝す。
鉤状突起は、例1Cに記述される方法と同様な方法を用いて水溶性物質で被覆される。
図1に記述される上記の例1Aのような初期プロステーシス織物を準備する。
ポリビニルアルコール(PVA)(87−89%加水分解型,Mw=31,000〜50,000、Sigma Aldrichから提供される)の溶液を磁気熱板スターラーを用いて90℃で加熱することによって溶液中に8%w/vで調製し、4%のグリセロールを添加し、次いで溶液を40℃に冷却する。
1)で得られた30mLの溶液を12cm×17cmシリコン枠にキャストする。プロステーシス織物の第2の面2bを前記溶液上に配置する。層流フード下、約10時間に亘る乾燥の後、溶液の層を少なくとも部分的にゲル化し、このように被覆されたプロステーシス織物を枠から剥離する。本発明に係るプロステーシス織物が得られ、それは、鉤状突起を含まないその面がPVAフィルムの形態にある微小多孔層で被覆される。このPVAフィルムは周囲温度で溶解されないが、37℃で溶解される。得られたPVAフィルムは孔がない、特に厳密に300μmより大きいサイズを有する孔のない平滑な外面を有する。
鉤状突起を例1Cに記述されるものと同様な方法を用いて水溶性物質により被覆する。
図1に記述された上記例1Aに示されるものと同様な初期プロステーシス織物を準備する。
a)3.4%w/vの酸化コラーゲンおよび1.4%w/vのグリセロールの溶液を例1に記述されるように準備する。
a)第1のフィルムを得ること:
1)で得られた30mLの溶液を12cm×17cmシリコン枠にキャストする。周囲温度で20〜30分間後にゲル化が生じる。第1のフィルムを得る。
a)においてキャスティングが行われた後の1時間、1d)で得られる溶液を第1のフィルム上にキャストする。20〜30分間後にこの新しい層のゲル化が生じる。乾燥を、周囲温度で、約10〜約14時間に亘り層流フード下で実行する。
鉤状突起を例1Cに記述される方法と同様な方法を用いて水溶性物質で被覆する。
図1に示された上述の例1Aと同様な初期プロステーシス織物を準備する。
8gのポークゼラチン(提供者:Sigma Aldrich)をグリセロールの5%w/v水溶液の92mLに溶解する。ゼラチン溶液を磁気撹拌にて45℃で溶解し、次いで50℃で10分間加熱する。得られた溶液の30mLを12cm×17cmボックスに熱キャストし、プロステーシス織物の面2bを溶液上に直接に配置する。周囲温度でのゼラチン溶液のゲル化の後、ボックスを20時間に亘り凍結乾燥する。ゼラチンの層で覆われるプロステーシス織物はボックスから容易に取り除かれる。ゼラチンの層またはメンブランは多孔質構造を有する:メンブランおよび例えばその外面は、20〜120μmで変化するサイズを持つ孔を有するが、300μmよりも大きなサイズの孔を有さない:走査型電子顕微鏡で撮影されたこのメンブランの写真を図3に示す:微小多孔層またはメンブランが300μmよりも大きなサイズの孔を含まないことが、この写真から明白に見える。したがって、このように得られたプロステーシス織物がそれ自身の周りに巻回される場合、鉤状突起は、微小多孔層の20〜120μmの範囲のサイズを有する孔内に貫通しない。鉤状突起は、微小多孔層の外面をすべり、互いに絡まない。
鉤状突起を例1Cに記述される方法と同様な方法を用いて水溶性物質で被覆する。
例1C,1Dおよび2−5で記述されるような被覆されたプロステーシス織物が製造され、ここで鉤状突起を覆うために用いられる水溶性物質はさらに生物活性剤をさらに含む。
Claims (26)
- 織物について少なくとも第1および第2の対向する面(2a、2b)を規定するヤーンのアレンジメント(2)を具備するプロステーシス織物(5)であって、織物は、少なくとも第1の面において、第1の面に関して外側に突出する1つまたは1つ以上の鉤状突起(3)を具備し、織物は、第2の面において、生物再吸収性物質で作られた層で少なくとも部分的に被覆されており、層の外面は鉤状突起が不貫通性であり、更に、鉤状突起が水溶性物質で作られた被覆剤で被覆されていることを特徴とするプロステーシス織物(5)。
- 請求項1に記載の織物(5)であって、不貫通性層が微小多孔層である織物。
- 請求項1または2に記載の織物(5)であって、不貫通性層が連続的であり、第2の面を完全に被覆していることを特徴とする織物。
- 請求項1〜3の何れか1項に記載の織物(5)であって、生物再吸収性物質が、コラーゲン化合物、親水性高分子化合物、ポリビニルアルコール、グリセロールおよびその混合物から選択されることを特徴とする織物。
- 請求項4に記載の織物(5)であって、生物再吸収性物質が少なくとも1つのコラーゲン化合物を含むことを特徴とする織物。
- 請求項1〜5の何れか1項に記載の織物(5)であって、コラーゲン化合物が酸化コラーゲンを含むことを特徴とする織物。
- 請求項5または6に記載される織物(5)であって、コラーゲン化合物がゼラチンを含むことを特徴とする織物。
- 請求項4に記載の織物(5)であって、親水性高分子化合物が、ポリアルキレングリコール、ポリサッカリド、酸化ポリサッカリド、ムコポリサッカリドおよびその混合物から選択されることを特徴とする織物。
- 請求項8に記載の織物(5)であって、前記ポリアルキレングリコールは、ポリエチレングリコールまたはポリプロピレングリコールから選択されることを特徴とする織物。
- 請求項8に記載の織物(5)であって、前記ポリサッカリドは、デンプン、デキストランおよび/またはセルロースの誘導体から選択されることを特徴とする織物。
- 請求項8〜10のいずれか1項に記載の織物(5)であって、親水性高分子化合物が4000ダルトンのモル質量を有するポリエチレングリコールであることを特徴とする織物。
- 請求項1〜11の何れか1項に記載の織物(5)であって、生物再吸収性物質が少なくとも1つのグリセロールを含むことを特徴とする織物。
- 請求項1〜4の何れか1項に記載の織物(5)であって、生物再吸収性物質が少なくともコラーゲン化合物および少なくとも1つのグリセロールを含むことを特徴とする織物。
- 請求項1〜13の何れか1項に記載の織物であって、生物再吸収性物質が更に少なくとも1つの親水性高分子化合物を含むことを特徴とする織物。
- 請求項1〜14の何れか1項に記載の織物(5)であって、生物再吸収性物質が少なくとも1つのポリビニルアルコールを含むことを特徴とする織物。
- 請求項1〜4の何れか1項に記載の織物であって、生物再吸収性物質が少なくとも1つのポリビニルアルコールおよび少なくとも1つのグリセロールを含むことを特徴とする織物。
- 請求項1〜4の何れか1項に記載の織物であって、生物再吸収性物質が、少なくとも1つのコラーゲン化合物および少なくとも1つのポリビニルアルコールを含むことを特徴とする織物。
- 請求項1〜17の何れか1項に記載の織物であって、生物再吸収性物質が少なくとも1つの生物活性剤を含むことを特徴とする織物。
- 請求項1〜18の何れか1項に記載の織物であって、水溶性物質が、ポリエチレングリコール(PEG)、ポリ酢酸ビニル(PVAc)、ゼラチン、ポリグルクロン酸、ヒアルロン酸、カルボキシメチルセルロース、セルロースエーテル、キトサンおよびその混合物から選択されることを特徴とする織物。
- 請求項1〜19の何れか1項に記載の織物であって、水溶性物質が少なくとも1つの生物活性剤を含むことを特徴とする織物。
- 織物について第1および第2の面(2a、2b)を規定するヤーンのアレンジメント(2)を具備するプロステーシス織物(1)を被覆する方法であって、織物は、少なくとも第1の面に亘り、第1の面に関して外側に突出する1つまたは1つ以上の鉤状突起(3)を具備し、以下の工程を具備することを特徴とする方法:
−a)少なくとも1つの生物再吸収性物質を含む溶液を準備すること;
−b)溶液の層を不活性支持体に対して適用すること;および
−c)層が少なくとも部分的にゲル化したときに、織物の第2の面を層に対して適用すること;および
−i)少なくとも1つの水溶性生体適合性物質を液体状態で含む組成物を準備すること;および
−ii)組成物の層を鉤状突起に対して適用すること;
ここにおいて、工程i)およびii)は、工程a)〜c)に対して何れかの順番で実行される。 - 請求項21に記載の方法であって、工程c)の間に、織物の第2の面の適用の前に、溶液の第2の層が部分的にゲル化された層に対して適用されることを特徴とする方法。
- 請求項21に記載の方法であって、工程c)の間に、織物の第2の面の適用の前に、生物再吸収性物質の第2の溶液の層が部分的にゲル化された層に対して適用され、生物再吸収性物質の第2の溶液の組成物がa)において得られる溶液とは異なることを特徴とする方法。
- 請求項21〜23の何れか1項に記載の方法であって、工程c)において得られるプロステーシス織物が20〜60時間の範囲の期間に亘り凍結乾燥されることを特徴とする方法。
- 請求項21〜24の何れか1項に記載の方法であって、工程ii)がロールを使用して実行されることを特徴とする方法。
- ヘルニアの治療のためのプロステーシスであって、請求項1〜20の何れか1項に記載の織物(5)から、または請求項21〜25の何れか1項に記載の方法により得られた織物から製造されたことを特徴とするプロステーシス。
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FR0956039A FR2949688B1 (fr) | 2009-09-04 | 2009-09-04 | Tissu avec picots revetu d'une couche microporeuse bioresorbable |
FR0956039 | 2009-09-04 | ||
PCT/EP2010/063062 WO2011026987A1 (en) | 2009-09-04 | 2010-09-06 | Gripping fabric coated with a bioresorbable impenetrable layer |
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2009
- 2009-09-04 FR FR0956039A patent/FR2949688B1/fr not_active Expired - Fee Related
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2010
- 2010-09-06 WO PCT/EP2010/063062 patent/WO2011026987A1/en active Application Filing
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US20240279852A1 (en) | 2024-08-22 |
WO2011026987A1 (en) | 2011-03-10 |
CA2772114A1 (en) | 2011-03-10 |
CA2772114C (en) | 2018-02-27 |
JP2013503673A (ja) | 2013-02-04 |
US11970798B2 (en) | 2024-04-30 |
FR2949688B1 (fr) | 2012-08-24 |
AU2010291108B2 (en) | 2014-06-26 |
AU2010291108A1 (en) | 2012-03-15 |
EP2473214B1 (en) | 2014-03-26 |
US10865505B2 (en) | 2020-12-15 |
EP2473214A1 (en) | 2012-07-11 |
FR2949688A1 (fr) | 2011-03-11 |
US20120197415A1 (en) | 2012-08-02 |
US20210189616A1 (en) | 2021-06-24 |
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