JP5594815B2 - 骨再生誘導膜およびその製造方法 - Google Patents
骨再生誘導膜およびその製造方法 Download PDFInfo
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- JP5594815B2 JP5594815B2 JP2009208922A JP2009208922A JP5594815B2 JP 5594815 B2 JP5594815 B2 JP 5594815B2 JP 2009208922 A JP2009208922 A JP 2009208922A JP 2009208922 A JP2009208922 A JP 2009208922A JP 5594815 B2 JP5594815 B2 JP 5594815B2
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- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 18
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- WYTZZXDRDKSJID-UHFFFAOYSA-N (3-aminopropyl)triethoxysilane Chemical compound CCO[Si](OCC)(OCC)CCCN WYTZZXDRDKSJID-UHFFFAOYSA-N 0.000 description 9
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- 229920002101 Chitin Polymers 0.000 description 1
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- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 102000009123 Fibrin Human genes 0.000 description 1
- 108010073385 Fibrin Proteins 0.000 description 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 1
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
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- 150000004781 alginic acids Chemical class 0.000 description 1
- AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 description 1
- 239000000920 calcium hydroxide Substances 0.000 description 1
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- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2803—Bones for mandibular reconstruction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30006—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in density or specific weight
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30971—Laminates, i.e. layered products
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
- A61F2250/0017—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight differing in yarn density
Landscapes
- Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Nonwoven Fabrics (AREA)
Description
第1、第2不織布層は、エレクトロスピニング法によって形成されたものであり、
第2不織布層の繊維状物質の平均直径は、第1不織布層の繊維状物質の平均直径よりも小さいことを特徴とする。
第1、第2不織布層をエレクトロスピニング法によって形成するとともに、第2不織布層を形成する際では、繊維状物質の平均直径を第1不織布層の繊維状物質の平均直径よりも小さく、前記繊維状物質の平均直径を、0より大きく5μm以下として、前記第2不織布層を形成することを特徴とする。この請求項5に記載の発明によれば、請求項1に記載の発明と同様の効果を奏する。
〔各実施例で用いた原料〕
・ポリ乳酸(PLA):分子量20-30万Da、PURAC biochem、または、分子量15〜17万Da、島津製作所
・クロロホルム(CHCl3):特級試薬、純度99.0%以上、キシダ化学株式会社
・γ−アミノプロピルトリエトキシシラン(APTES):(TSL8331、純度98%以上、GE東芝シリコーン株式会社)
・シロキサン含有炭酸カルシウム(Si-CaCO3):消石灰(ミクロスターT、純度96%以上、矢橋工業株式会社)、メタノール(特級試薬、純度99.8%以上、キシダ化学株式会社)、APTES、炭酸ガス(高純度液化炭酸ガス、純度99.9%、大洋化学工業株式会社)を用いて調製された、シロキサンを含む(ケイ素イオン量換算で2.9重量%)のバテライト
(実施例1)
第1不織布層としてSi-PLA層を作製し、第2不織布層として平均直径が異なる2種類のPLA層(5μmφ、1〜2μmφ)を作製した。
具体的には、分子量15〜17万DaのPLA1.0gをクロロホルムに溶解して8%のPLA溶液としたものに、APTES67%の水溶液0.075gを混合撹拌したものを、Si-PLA層を作製するための紡糸溶液とした。
また、平均5μmφのPLA層を作製するために、分子量15〜17万DaのPLAを9%とクロロホルム91%を混合して9%のPLA溶液とし、これを紡糸溶液とした。さらに、平均1〜2μmφのPLA層を作製するために、分子量15〜17万DaのPLAを9%、クロロホルムを76%、メタノールを15%とを混合撹拌して紡糸溶液とした。
紡糸溶液供給速度:約0.05 ml/min、印加電圧:20 kV、ノズルとコレクターの距離:15 cm、ノズル:15 cm/minで左右(15 cm幅)に移動、コンベア式コレクター(コンベア速度:2 m/min)、紡糸時間:約60min
図1の走査型電子顕微鏡(SEM)写真に第1不織布層としてのSi- PLA層の微構造を示す。第1不織布層を構成する繊維状物質の直径は10μm前後であることが確認できる。
試料A、B、Cを水銀ポロシメータ(島津製作所、Poresizer9320)を用いて気孔率、および気孔系を測定した結果を図4に示す。試料A、B、Cは、それぞれ、実施例1のSi-PLA層、PLA層(5μmφ)、PLA層(1〜2μmφ)である。求められた気孔率は、A:86μm、B:81μm、C:70μmであり、3試料間で大きな差はなかった。しかし、気孔径は差が見られ、A:42μm、B:17μm、C:11μmであった。
〔細胞培養実験の条件〕
細胞種;マウス骨芽細胞様細胞(MC3T3-E1細胞:理研)
24wellプレート使用細胞播種数;1×104cell/well(A、B、Cの3種類のサンプルをそれぞれ24 wellプレートに入れ、予め10%ウシ胎仔血清含有α-MEM培地に1 hさらした後、播種)
培養培地;α-MEM(10%ウシ胎仔血清含有)
培地交換;播種翌日、その後は1日おき
培養:各懸濁液1 mLをサンプル表面に滴下し、そのままの状態で1, 6, 13 d培養(インキュベーター内にて5% CO2、37 oC環境下保持)。
(実施例2)
第1不織布層としてSi-CaCO3/PLA層を作製し、第2不織布層としてPLA層を作製した。具体的には、 第1不織布層(Si-CaCO3/PLA層)用の紡糸溶液として、Si-CaCO3:1.5g、分子量15〜17万のPLA:1.0g、クロロホルム:9.0gを混合した紡糸溶液(Si-CaCO3:13.0%、PLA:8.7%)を準備し、第2不織布層(PLA層)用の紡糸溶液として、分子量15〜17万DaのPLA 1gをクロロホルム10.11gに溶解して紡糸溶液(PLA:9%)とした。これらの紡糸溶液を用いて、エレクトロスピング法により不織布2層構造を有するGBR膜を作製した。
紡糸溶液供給速度:約0.24 ml/min、印加電圧:20 kV、ノズルとコレクターの距離:15 cm、ノズル:10 cm/minで左右(15 cm幅)に移動、コンベア式コレクター(コンベア速度:2 m/min)、紡糸時間:約180 min
[PLA層作製条件]
紡糸溶液供給速度:約0.05 ml/min、印加電圧:20kV、ノズルとコレクターの距離:15 cm、ノズル:15 cm/minで左右(15 cm幅)に移動、コンベア式コレクター(コンベア速度:2 m/min)、紡糸時間:約180 min
図6の走査型電子顕微鏡(SEM)写真に第1不織布層としてのSi-CaCO3/PLA層の微構造を示す。第1不織布層を構成する繊維状物質の直径は10〜20μm程度であることが確認できる。図7のSEM写真に第2不織布層としてのPLA層の微構造を示す。第2不織布層を構成する繊維状物質の直径は5μm前後であることが確認できる。
Claims (8)
- 生分解性樹脂を主成分としシロキサンを含有する繊維状物質で構成された第1不織布
層と、生分解性樹脂を主成分とする繊維状物質で構成された第2不織布層との2層構造を有する骨再生誘導膜において、
前記第1、第2不織布層は、エレクトロスピニング法によって形成されたものであり、
前記第2不織布層の前記繊維状物質の平均直径は、前記第1不織布層の前記繊維状物質の平均直径よりも小さく、前記第2不織布層を構成する前記繊維状物質の平均直径は、0よりも大きく5μm以下であることを特徴とする骨再生誘導膜。 - 前記第1不織布層を構成する前記繊維状物質の平均直径は、10μm以上20μm以下
であることを特徴とする請求項1に記載の骨再生誘導膜。 - 前記第1不織布層を構成する前記繊維状物質は、前記シロキサンが炭酸カルシウム
微粒子に分散された状態で前記繊維状物質に組み込まれたものであることを特徴とする
請求項1または2に記載の骨再生誘導膜。 - 前記生分解性樹脂がポリ乳酸またはその共重合体である請求項1ないし3のいずれ
か1つに記載の骨再生誘導膜。 - 生分解性樹脂を主成分としシロキサンを含有する繊維状物質で構成された第1不織
布層と、生分解性樹脂を主成分とする繊維状物質で構成された第2不織布層との2層構
造を有する骨再生誘導膜の製造方法において、
前記第1、第2不織布層をエレクトロスピニング法によって形成するとともに、
前記第2不織布層を形成する際では、前記繊維状物質の平均直径を前記第1不織布
層の前記繊維状物質の平均直径よりも小さく、前記繊維状物質の平均直径を、0より大
きく5μm以下として、前記第2不織布層を形成することを特徴とする骨再生誘導膜の製造方法。 - 前記第1不織布層を構成する前記繊維状物質の平均直径を、10μm以上20μm以下
とすることを特徴とする請求項5に記載の骨再生誘導膜の製造方法。 - 前記第1不織布層を構成する前記繊維状物質として、前記シロキサンが炭酸カルシウム微粒子に分散された状態で前記繊維状物質に組み込まれたものを用いて、前記第1不織布層を形成することを特徴とする請求項5または6に記載の骨再生誘導膜の製造方法。
- 前記生分解性樹脂としてポリ乳酸またはその共重合体を用いることを特徴とする請求項5ないし7のいずれか1つに記載の骨再生誘導膜の製造方法。
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