JP5801719B2 - 骨インプラント基材及びその調製方法 - Google Patents
骨インプラント基材及びその調製方法 Download PDFInfo
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- JP5801719B2 JP5801719B2 JP2011541629A JP2011541629A JP5801719B2 JP 5801719 B2 JP5801719 B2 JP 5801719B2 JP 2011541629 A JP2011541629 A JP 2011541629A JP 2011541629 A JP2011541629 A JP 2011541629A JP 5801719 B2 JP5801719 B2 JP 5801719B2
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Transplantation (AREA)
- Dermatology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Biomedical Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials Engineering (AREA)
- Composite Materials (AREA)
- Zoology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Botany (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
Description
a)下記b)の補強用混合物を用いて処理された又は処理可能なベース基材
b)少なくとも1種のポリマーを含有する補強用混合物
を含む。
a)少なくとも1種のポリマーを含有する補強用混合物の溶液を調製する工程と、
b)ベース基材を、工程a)に従って作製された補強用混合物に浸漬する工程と、
c)(例えば、大気中で、好適には真空炉中で)残留溶媒を除去するために、工程b)に従って作製された基材を、好適には真空炉中で37°C(±2°C)で24時間、乾燥させかつ脱気する工程と、を備える。
d)無菌かつ不活性雰囲気下での包装工程、
e)殺菌工程(好適には、ガンマ線又はベータ線照射による)。
20mLのジクロロメタン中に1gのポリマーを加えて溶液を調製した。
20mLのジクロロメタンに1gのPLA/PCLコポリマーを加えて、溶液を調製した。マグネティックスターラーを用いて、約100rpmの撹拌速度で、室温で少なくとも45分間撹拌し続けた。
20mLのジクロロメタンに1gのPLA/PCLコポリマーを加えて、溶液を調製した。十分に均一分散した溶液を得るために、室温で少なくとも45分間撹拌し続けた。
20mLのジクロロメタンに1gのP(L,DL)LAコポリマーを加えて溶液を調製した。十分に均一分散した溶液を得るために、室温で少なくとも45分間撹拌し続けた。
いくつかの基質の光学顕微鏡検査を、ツァイス−ケンブリッジインストルメンツ社(ドイツ)のESEMsystemEvo50EPを用いて行った。
Claims (10)
- 骨インプラント基材であって、
b)下記ベース基材の全表面上に細かく分散された均一なコーティングとしての補強用混合物であって、
少なくとも1種のポリマーと、細胞親和性物質(該細胞親和性物質は、細胞増殖及び組織結合を促進することによって、細胞の定着及び細胞の成長を促進することができる物質である)から選択される少なくとも1種の追加的な構成成分と、を含有する補強用混合物、及び
a)前記補強用混合物で処理されたベース基材
を含み、
該ベース基材が、ウシ由来の、脱灰骨若しくは非脱灰骨又は無細胞化骨基質であり、
該補強用混合物の該ポリマーが、生分解性のポリエステル又はそのコポリマーであり、
該細胞親和性物質が、ゼラチン及び加水分解されたゼラチンからなる群より選択される、骨インプラント基材。 - 前記生分解性のポリエステル又はそのコポリマーが、ポリ乳酸(PLA)、ポリグリコール酸(PGA)、ポリカプロラクトン(PCL)、並びにポリカプロラクトン−ポリ乳酸(PLA/PCL)コポリマー、ポリ(L−ラクチド−コ−ε−カプロラクトン)コポリマー、ポリ(L−ラクチド)、ポリ(D,L−ラクチド−コ−グリコリド)及びポリ(L−ラクチド−コ−D,L−ラクチド)を含むそれらのコポリマー、それらのエナンチオマー、それらのコポリマー、並びにそれらの混合物からなる群から選択される、請求項1記載の骨インプラント基材。
- 前記補強用混合物が、少なくとも1種のポリマーと、ゼラチン及び加水分解されたゼラチンからなる群より選択される少なくとも1種の追加的な構成成分とを含有し、
前記ベース基材が、ウシ非脱灰無細胞化骨基質であり、
該補強用混合物の該ポリマーが、ポリ乳酸(PLA)、ポリグリコール酸(PGA)、ポリカプロラクトン(PCL)、並びにポリカプロラクトン−ポリ乳酸(PLA/PCL)コポリマー、ポリ(L−ラクチド−コ−ε−カプロラクトン)コポリマー、ポリ(L−ラクチド)、ポリ(D,L−ラクチド−コ−グリコリド)及びポリ(L−ラクチド−コ−D,L−ラクチド)を含むそれらのコポリマー、それらのエナンチオマー、それらのコポリマー、並びにそれらの混合物からなる群から選択される生分解性のポリエステル又はそのコポリマーである、請求項1記載の骨インプラント基材。 - 生分解性のポリエステルベースのコポリマー及び加水分解されたゼラチンを含む補強用混合物で処理されたウシ脱灰骨基質を含む、請求項1記載の骨インプラント基材。
- 生分解性のポリエステルベースのコポリマー及び加水分解されたゼラチンを含む補強用混合物で処理されたウシの無細胞化骨基質を含む、請求項1記載の骨インプラント基材。
- 生分解性のポリエステルベースのコポリマー及び加水分解されたゼラチンを含む補強用混合物で処理された、ウシ非脱灰無細胞化骨基質を含む、請求項1記載の骨インプラント基材。
- 前記生分解性のポリエステルベースのコポリマーが、ポリカプロラクトン−ポリ乳酸(PLA/PCL)コポリマーである、請求項4〜6のいずれか1項に記載の骨インプラント基材。
- 前記生分解性のポリエステルベースのコポリマーが、ポリ(L−ラクチド−コ−ε−カプロラクトン)コポリマーである、請求項4〜6のいずれか1項に記載の骨インプラント基材。
- 骨再建手術、顎顔面の骨再建手術、口腔外科、歯科外科、整形外科及びインプラント学の分野のうちの少なくとも1つで使用される、請求項1記載の骨インプラント基材。
- ヒト又は獣医科の治療に使用される、請求項1記載の骨インプラント基材。
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PCT/IB2009/007759 WO2010070416A1 (en) | 2008-12-19 | 2009-12-15 | Bone implant matrix and method of preparing the same |
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