JP4499143B2 - 人工血管用二重膜構造のチューブ型多孔性スキャフォールド及びその製造方法 - Google Patents
人工血管用二重膜構造のチューブ型多孔性スキャフォールド及びその製造方法 Download PDFInfo
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Classifications
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- 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
- A61L27/56—Porous materials, e.g. foams or sponges
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
- B29C70/04—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts comprising reinforcements only, e.g. self-reinforcing plastics
- B29C70/28—Shaping operations therefor
- B29C70/30—Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core
- B29C70/32—Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core on a rotating mould, former or core
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- 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
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- 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
- A61L27/52—Hydrogels or hydrocolloids
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
- D01D5/00—Formation of filaments, threads, or the like
- D01D5/04—Dry spinning methods
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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
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
- D01D5/00—Formation of filaments, threads, or the like
- D01D5/0007—Electro-spinning
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Mechanical Engineering (AREA)
- Composite Materials (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Pulmonology (AREA)
- Dispersion Chemistry (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Textile Engineering (AREA)
- Materials Engineering (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Description
1)生分解性高分子を有機溶媒に溶解させ、ポロゲンを混合して高分子/ポロゲンの混合液を製造する段階と、
2)円筒状シャフトを前記高分子/ポロゲンの混合液でコーティングして多孔性コーティング層の内膜を形成する段階と、
3)生分解性高分子を有機溶媒に溶解させて生分解性高分子ゲルを製造する段階と、
4)段階2)で多孔性コーティング層の内膜が形成された円筒状シャフトを非溶媒の凝固槽に漬けて回転させながら、前記生分解性高分子ゲルを落下紡糸して形成されたゲル状態の繊維を前記シャフトの多孔性コーティング層の内膜を巻くようにして高分子繊維層の外膜を形成する段階と、
5)前記シャフトに形成された二重膜構造の多孔性スキャフォールドを分離し、これから有機溶媒及びポロゲンを除去する段階と
を備えた、二重膜構造のチューブ型多孔性スキャフォールドの製造方法を提供する。
Claims (15)
- 1)生分解性高分子を有機溶媒に溶解させ、ポロゲンを混合して高分子/ポロゲンの混合液を製造する段階と、
2)円筒状シャフトを前記高分子/ポロゲンの混合液でコーティングし、多孔性コーティング層の内膜を形成する段階と、
3)生分解性高分子を有機溶媒に溶解させ、生分解性高分子ゲルを製造する段階と、
4)段階2)で多孔性コーティング層の内膜が形成された円筒状シャフトを非溶媒の凝固槽に漬けて回転させながら、前記生分解性高分子ゲルを落下紡糸して形成されたゲル状態の繊維を前記シャフトの多孔性コーティング層の内膜を巻くようにして高分子繊維層の外膜を形成する段階と、
5)前記シャフトに形成された二重膜構造の多孔性スキャフォールドを分離し、これから有機溶媒及びポロゲンを除去する段階と、
を備える、二重膜構造のチューブ型多孔性スキャフォールドの製造方法。 - 段階1)において生分解性高分子がポリ(L−乳酸)、ポリ(D、L−乳酸)、ポリ(グリコール酸)、ポリ(カプロラクトン)、ポリ(ヒドロキシアルカノエート)、ポリジオキサノン、ポリトリメチレンカルボネート、これらの誘導体及び共重合体で構成された群より選択されることを特徴とする請求項1に記載の製造方法。
- 段階1)において生分解性高分子が5,000〜1,000,000ダルトンの範囲の分子量を有することを特徴とする請求項1に記載の製造方法。
- 段階1)において生分解性高分子が有機溶媒に重量/体積比で1〜20%の量で溶解することを特徴とする請求項1に記載の製造方法。
- 段階1)において有機溶媒がクロロホルム、メチレンクロリド、酢酸、エチルアセテート、ジメチルカルボネート及びテトラヒドロフランで構成される群より選択されることを特徴とする請求項1に記載の製造方法。
- 段階1)においてポロゲンが、塩、二炭酸ナトリウム、二炭酸アンモニウム、パラフィン及びポリエチレングリコールで構成される群より選択されることを特徴とする請求項1に記載の製造方法。
- 段階1)においてポロゲンが生分解性高分子と重量比で9:1〜1:2の範囲で混合されることを特徴とする請求項1に記載の製造方法。
- 段階2)においてコーティングが、押出成形法、含浸法、電気紡糸法、凍結乾燥法、相−分離法、粒子浸出法、ガス−形成法(gas-foaming)、炭化水素鋳型法(hydrocarbon templating)及び溶融鋳造法(melt molding)で構成される群より選択される方法により行われることを特徴とする請求項1に記載の製造方法。
- 段階2)において多孔性コーティング層の内膜に形成された気孔が40ミクロン以下のサイズを有することを特徴とする請求項1に記載の製造方法。
- 段階3)において生分解性高分子ゲル内の生分解性高分子の濃度が4〜20重量%であることを特徴とする請求項1に記載の製造方法。
- 段階4)においてゲル状態の繊維が50〜150ミクロンの直径を有し、高分子繊維層の外膜に形成された気孔が10〜500ミクロンのサイズを有することを特徴とする請求項1に記載の製造方法。
- 段階4)において非溶媒が、メタノール、エタノール、ブタノール、ヘキサン、ヘプタン、及びシクロヘキサンで構成された群より選択されることを特徴とする請求項1に記載の製造方法。
- 段階5)において有機溶媒及びポロゲンが減圧乾燥及び溶解させる方法により除去されることを特徴とする請求項1に記載の製造方法。
- 請求項1の製造方法により製造された、多孔性コーティング層の内膜と高分子繊維層の外膜の二重膜構造を有する生分解性及び生体適合性の人工血管用チューブ型多孔性スキャフォールド。
- 多孔性コーティング層の内膜が40ミクロン以下のサイズの気孔を有し、高分子繊維層の外膜が10〜500ミクロンサイズの気孔を有することを特徴とする請求項14に記載のチューブ型多孔性スキャフォールド。
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JP2009011804A (ja) | 2009-01-22 |
KR100932688B1 (ko) | 2009-12-21 |
US20090012607A1 (en) | 2009-01-08 |
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