WO2004110514A1 - 生体用適合膜 - Google Patents
生体用適合膜 Download PDFInfo
- Publication number
- WO2004110514A1 WO2004110514A1 PCT/JP2004/008465 JP2004008465W WO2004110514A1 WO 2004110514 A1 WO2004110514 A1 WO 2004110514A1 JP 2004008465 W JP2004008465 W JP 2004008465W WO 2004110514 A1 WO2004110514 A1 WO 2004110514A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- membrane
- biocompatible
- biocompatible membrane
- powder
- biodegradable resin
- Prior art date
Links
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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- 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
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L27/58—Materials at least partially resorbable by the body
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
- A61C8/0003—Not used, see subgroups
- A61C8/0004—Consolidating natural teeth
- A61C8/0006—Periodontal tissue or bone regeneration
Definitions
- the present invention relates to a biocompatible membrane used for regenerating a tissue or a bone in a medical field such as dentistry, oral surgery, or orthopedic surgery, and a method for producing the same.
- biocompatible membranes used for regenerating tissues or bones in medical fields such as dentistry and oral surgery consist of homopolymers such as glycolic acid, lactic acid, and lactic prolactone, or copolymers or mixtures thereof. It is a material (Japanese Unexamined Patent Publication No. 6-504702). Sponge-like materials composed of a material containing a polymer ceramic material having fine pores (Japanese Patent Application Laid-Open No. Hei 6-319794), a polycondensate of lactic acid, glycolic acid, or force prolactone or a copolymer thereof (Japanese Patent Application Laid-Open No.
- a bioabsorbable membrane that forms pores that are completely penetrated by forming a polymer material for the membrane into an emulsion solution and then molding JP-A-11_80415) and collagen II Multilayer film (Japanese Patent Publication No. 2001-519210), composed of a polymer blend material selected from homopolymers or copolymers of L-lactic acid, DL-lactic acid, glycolic acid, and ⁇ -force prolactone, and having a pore size of 1 to 50
- a material having a porous sheet-like structure having ⁇ , a porosity of 5 to 95%, and a thickness of 50 to 500 m Japanese Patent Application Laid-Open No. 2002-85547.
- Methods for producing these biocompatible membranes include, for example, a method of forming a film by evaporating a solvent from a homogeneous solution of a polymer material dissolved in methylene chloride (Japanese Patent Application Laid-Open No. 6-504702), an emulsion solution and a shape-retaining material.
- a method of coating and drying and then removing the film from the shape-retaining material JP-A-11-180415.
- consideration must be given to producing a homogeneous film because an organic solvent is used.
- the manufacturing process becomes complicated.
- An object of the present invention is to provide a biocomposite membrane having a shape, a size, a porosity, a film thickness, and the like according to an application purpose and an application site in a short time and at low cost without taking complicated manufacturing steps. Is to do.
- the present inventors have conducted intensive studies to solve the above-mentioned problems, and as a result, in producing a biocompatible film, by using a powder sintering lamination method using a laser that irradiates a laser to a biodegradable resin powder.
- the present inventors have found that a homogeneous biocompatible membrane having an optimal form according to its application purpose and application site can be manufactured in a short time and at low cost, and have completed the present invention.
- the biocompatible membrane according to the present invention is a biodegradable membrane produced by a powder sintering lamination method using a laser, and is a very homogeneous membrane in the fields of dentistry, oral surgery, orthopedic surgery and the like. It can be used for treatment for bone regeneration or tissue regeneration.
- the method for producing a biocompatible membrane according to the present invention includes a step of irradiating a biodegradable resin powder with a laser to form a powder. Complex manufacturing process of homogeneous biocomposite membrane with porosity, film thickness, etc. It can be manufactured in a short time and at low cost without taking steps.
- the present invention relates to the following production method and biocompatible membrane.
- Item 1 A method for producing a biocompatible film comprising a step of irradiating a laser to the biodegradable resin powder to form a powder.
- Item 2 The production method according to Item 1, wherein the biodegradable resin powder has an average particle size of 0.001 to 0.3 mm.
- Item 3 A biocompatible membrane produced by the production method according to Item 1 or 2.
- Item 4 The biocompatible film according to Item 3, which is a multilayer film having a gap between the films.
- Item 5 The biocompatible film according to Item 3 or 4, wherein the thickness of one layer is 0.01 to 0.2 mm.
- Item 6 The biocompatible membrane according to any one of Items 3 to 5, having a small hole penetrating the membrane and / or a rectangular hole penetrating the membrane.
- Item 8 The biodegradable resin according to Items 3 to 7, wherein the biodegradable resin is a homopolymer, a copolymer, or a mixture of at least one compound selected from the group consisting of lactic acid, glycolic acid, and ⁇ -force prolactone.
- the biocompatible membrane according to any one of the above.
- Item 9 The biocompatible membrane according to any one of Items 3 to 8, further comprising a bioabsorbable plasticizer.
- Item 10 The biocompatible membrane according to any one of Items 3 to 9, which is a bioabsorbable tissue regeneration membrane.
- Item 11 The biocompatible membrane according to any one of Items 3 to 9, which is a bioabsorbable bone regeneration membrane.
- Item 1 2. The biocompatible membrane according to any one of Items 3 to 11, which is for dental use.
- the biocompatible material used in the present invention is not particularly limited.
- the biodegradable resin is preferably a homopolymer, a copolymer of at least one compound selected from the group consisting of lactic acid, glycolic acid and ⁇ -force prolactone, or a mixture of these polymers, and more preferably polylactic acid. It is.
- the average molecular weight of the biodegradable resin is approximately 2000 to 2000, preferably 2000 to 5000, and the average particle size is 0.001 to 0.001. 0.3 mm is preferred, and 0.001 to 0.1 mm is most preferred.
- the biocompatible material having such an average particle diameter can be obtained by, for example, pulverizing a conventionally known biocompatible material at a temperature of ⁇ 120 ° C. or lower at a low temperature, or dispersing it in ⁇ or a solvent to remove the solvent. Can be obtained.
- biodegradable plasticizers such as citrate esters such as acetyl-triethyl ⁇ -butyl and triethyl citrate, malate esters, and ester adipic acid may be blended. And the irritation to the tissue at the time of transplantation is improved. At this time, the biodegradable plasticizer can be blended in an amount of 3 to 30% by weight based on the biodegradable resin. When the amount of the biodegradable plasticizer is within this range, it is advantageous in terms of moldability.
- growth factors for bone and living tissue growth factors for bone and living tissue, tetracyclines such as minocycline and doxycycline, macrolides such as clarithromycin and azithromycin, new quinolones such as lepofloxacin, terithromycin
- tetracyclines such as minocycline and doxycycline
- macrolides such as clarithromycin and azithromycin
- new quinolones such as lepofloxacin
- terithromycin Anti-inflammatory agents such as non-steroids such as flurbiprofen, steroids such as dexamethasone, azulene etc.
- Drugs such as bone resorption inhibitors such as natural products and bisphosphonates can be appropriately compounded.
- the powder molding process used may be a powder sintering lamination method using a laser. That is, according to the present method, the powder of the biodegradable resin having an average particle diameter of 0.001 to 0.3 mm prepared in advance can be converted into the dimensions of a three-dimensional model model designed in advance in CAD or the like. It is controlled on the basis of information and is provided on a support so as to correspond exactly to a predetermined distance and thickness. If necessary, the powder surface may be smoothed with a wiper or the like. Next, a laser such as a carbon dioxide gas laser is irradiated so as to correspond to the model, and the biodegradable resin powder is dissolved and solidified. By repeating this operation by moving the support in the vertical direction and repeating, an object corresponding to the model can be formed.
- a laser such as a carbon dioxide gas laser
- an object having a thickness such as a single-layer film, a laminated film, or a laminated film having a gap between the films, and a hole having a predetermined shape penetrated through the object, can be formed inside and outside the object. It is possible to give a specific shape such as unevenness to the surface and to optimize it for the purpose of application of biocompatible membrane.
- the laser used in this molding method is not particularly limited, and examples thereof include an infrared laser, a carbon dioxide laser, a solid laser such as YAG, an excimer laser, and the like.
- the output and diameter of these lasers are appropriately selected depending on the biodegradable resin used, the shape of the object, and the like.
- the biocompatible membrane of the present invention is preferably used as a bioabsorbable tissue regeneration membrane or a bioabsorbable bone regeneration membrane. These membranes can be used as therapeutic materials in the field of oral cavity surgery, orthopedic surgery, and as membranes used in stem cell culture for regenerative medicine.
- a multilayer film having voids (for example, FIG. 1) is preferable. More specifically, the film is composed of at least two layers, and one layer has a thickness of 0.01 to 0.2 mm, and preferably 0.2 to 0.7 mm as a whole multilayer film.
- the diameter of the hole is 0.05 to 0.5 mm, and one side of the rectangular hole is 0.05 to 2 mm.
- a porous film having a porosity of 1 to 60% is preferable.
- the membrane of the present invention can be used in addition to these shapes. It can also be suitably manufactured to the optimal size for the form. For example, a barrier monolayer used in periodontal tissue regeneration therapy (GTR method) can be manufactured.
- GTR method periodontal tissue regeneration therapy
- FIG. 1 is a first view of a periodontal tissue regenerating membrane produced in Example 1.
- FIG. 2 is a schematic diagram showing the size and distribution of small holes present on the upper surface of the periodontal tissue regeneration film manufactured in Example 1.
- FIG. 3 is a schematic diagram showing the size and distribution of rectangular holes present on the lower surface of the periodontal tissue regeneration membrane manufactured in Example 1. BEST MODE FOR CARRYING OUT THE INVENTION
- the present invention will be described more specifically with reference to examples, but the present invention is not limited thereto.
- Rice granular polylactic acid (molecular weight: about 1500) was pulverized at a low temperature of -120 ° C to obtain a fine powder (average particle diameter: 100 ⁇ m).
- the regenerated periodontal tissue membrane with a two-layer structure is imported in advance as three-dimensional CAD data, and this fine powder is injected into a powder additive manufacturing machine to directly model from this data. Under an atmosphere of 155 ° C, this fine powder is supplied flat to a fixed thickness into a molding table of this machine by a movable container, and a fine carbon dioxide laser (50 W) Fine powder of a certain thickness is sintered or melt-fixed according to the three-dimensional cross section.
- the target periodontal tissue regeneration membrane was formed (Fig. 1). Although no holes are shown in FIG. 1, the obtained membrane has a circular hole shown in FIG. 2 on the upper surface, and a rectangular hole shown in FIG. 3 on the lower surface. The porosity is 40% and the porosity of the lower surface is 33%. The film thickness is 0.4 mm. Industrial potential
- homopolymers such as lactic acid, glycolic acid, and ⁇ -force prolactone are provided.
- -A biocompatible membrane manufactured using a biodegradable resin powder such as a copolymer or a mixture of these polymers as a material and manufactured using a three-dimensional powder molding method is suitable for the site to be used, its purpose, and application. Since it has a unique shape, it is possible to provide an optimal biocompatible membrane according to the case.
- the period from the time when the biocompatible membrane of the present invention is installed in a living body to the time when the biocompatible membrane is decomposed is a bioabsorbable tissue regeneration membrane, a bioabsorbable tissue used in a treatment area such as dentistry, oral surgery, and orthopedic surgery. Since it is suitable for a bone regeneration membrane, it can be particularly effectively used as a regeneration membrane in these fields.
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- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2003166039A JP2006187303A (ja) | 2003-06-11 | 2003-06-11 | 生体用適合膜 |
JP2003-166039 | 2003-06-11 |
Publications (1)
Publication Number | Publication Date |
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WO2004110514A1 true WO2004110514A1 (ja) | 2004-12-23 |
Family
ID=33549245
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2004/008465 WO2004110514A1 (ja) | 2003-06-11 | 2004-06-10 | 生体用適合膜 |
Country Status (2)
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JP (1) | JP2006187303A (ja) |
WO (1) | WO2004110514A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005105164A1 (ja) * | 2004-04-30 | 2005-11-10 | Sunstar Suisse Sa | 生体適合膜及びその製造方法 |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8853298B2 (en) | 2009-07-10 | 2014-10-07 | Nagoya Institute Of Technology | Fiber wadding for filling bone defects |
JP5683160B2 (ja) * | 2010-07-26 | 2015-03-11 | グンゼ株式会社 | 生体吸収性骨再生用フィルム及びgbr用メンブレン |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001150556A (ja) * | 1999-09-14 | 2001-06-05 | Minolta Co Ltd | 三次元造形装置および三次元造形方法 |
JP2002085547A (ja) * | 2000-09-11 | 2002-03-26 | Gc Corp | 歯科用吸収性組織再生膜 |
-
2003
- 2003-06-11 JP JP2003166039A patent/JP2006187303A/ja not_active Withdrawn
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2004
- 2004-06-10 WO PCT/JP2004/008465 patent/WO2004110514A1/ja active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001150556A (ja) * | 1999-09-14 | 2001-06-05 | Minolta Co Ltd | 三次元造形装置および三次元造形方法 |
JP2002085547A (ja) * | 2000-09-11 | 2002-03-26 | Gc Corp | 歯科用吸収性組織再生膜 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005105164A1 (ja) * | 2004-04-30 | 2005-11-10 | Sunstar Suisse Sa | 生体適合膜及びその製造方法 |
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JP2006187303A (ja) | 2006-07-20 |
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