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WO2008117949A1 - Membranes barrières pour régénération osseuse guidée - Google Patents

Membranes barrières pour régénération osseuse guidée Download PDF

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Publication number
WO2008117949A1
WO2008117949A1 PCT/KR2008/001500 KR2008001500W WO2008117949A1 WO 2008117949 A1 WO2008117949 A1 WO 2008117949A1 KR 2008001500 W KR2008001500 W KR 2008001500W WO 2008117949 A1 WO2008117949 A1 WO 2008117949A1
Authority
WO
WIPO (PCT)
Prior art keywords
substrate
barrier membrane
guided bone
bio
gold
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2008/001500
Other languages
English (en)
Inventor
Doug-Youn Lee
Sang-Bae Lee
Kyeong-Jun Park
Jeong-Jong Park
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Yesbio Co Ltd
Original Assignee
Yesbio Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from KR1020080023982A external-priority patent/KR100970717B1/ko
Application filed by Yesbio Co Ltd filed Critical Yesbio Co Ltd
Priority to US12/450,439 priority Critical patent/US20100028409A1/en
Publication of WO2008117949A1 publication Critical patent/WO2008117949A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular 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
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials

Definitions

  • the present invention relates to a barrier membrane for guided bone and tissue regeneration, and more particularly, a barrier membrane for guided bone and tissue regeneration capable of securing biocompat ibi 1 ity, exclusion and sealing of cells, space maintenance, connectivity with tissues, and easiness of using the barrier membrane by forming a polymer layer and a bio- ceramic layer respectively on upper and lower surfaces of a substrate made of gold (Au) which has texture including protrusions with predetermined shapes.
  • Au gold
  • a surgical operation or non-surgical operation may be performed.
  • Bone graft and guided tissue regeneration (GTR) for regenerating the destroyed periodontal tissues are clinically performed as the surgical operation.
  • GTR guided tissue regeneration
  • an alveolar bone is not recovered by attaching the epithelium through a simple periodontal curettage or operation. Accordingly, the GTR for guiding formation of bone by using a barrier membrane for periodontal tissue regeneration has been widely employed.
  • the GTR that has been clinically used since 1986 is referred to regeneration of a new periodontal ligament formed by cells originated from a periodontal ligament which is attached to new cementurn.
  • gingival epitheliums and connective tissues are excluded by inserting a barrier membrane between a root surface and a valve which are cleansed when performing flap surgery, and it is possible to attach new periodontal tissues by moving only periodontal ligament cells and periodontal bone cells under a wounded part to the wounded part.
  • the barrier membrane is used for the aforementioned regeneration.
  • the barrier membrane is used to prevent epithelium cells from moving to a root apex, prevents gingival fibers from penetrating into a damaged part, and induces growth of cells from periodontal ligaments and a periodontal bone.
  • the barrier membrane used for the GTR may be divided into absorbent and Linabsorbent barrier membranes.
  • the absorbent barrier membrane accommodates patients without an additional operation for removing the absorbent barrier membrane, thereby reducing costs. Accordingly, recently, research on the absorbent barrier membrane has been actively performed. However, reaction of tissues may be unavoidably caused due to resolvabi 1 ity of the absorbent barrier membrane in a human body. In case of a material with high absorptivity, an inflammation reaction may occur. In addition, it is advantageous that the absorbent barrier membrane is resolved in the human body. The absorbent barrier membrane is deficient in strength and shape allowance. Thus, the absorbent barrier membrane dose not satisfy a condition that a structure with a predetermined shape (in vivo structure) has to be maintained in the human body for 4 to 6 weeks based on a biological principle.
  • the present invention provides a barrier membrane for guided bone regeneration that is an unabsorbent barrier layer that secures biocompatibi lity, exclusion and sealing of cells, space maintenance, connectivity with tissues, and easiness of using the barrier membrane [Technical Solution]
  • a barrier membrane for guided bone regeneration comprising a substrate having a previously set thickness, wherein the substrate is made of gold, silver, or gold alloy obtained by adding an element such as platinum (Pt), palladium (Pd), silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like to gold, and wherein the substrate has texture with arbitrary shapes.
  • a barrier membrane for guided bone regeneration comprising a substrate having a previously set thickness, wherein the substrate is made of gold, silver, or gold alloy obtained by adding an element such as platinum (Pt), palladium (Pd), silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like to gold.
  • the barrier membrane for guided bone regeneration may further include a polymer layer containing an antibiotic on an upper surface of the substrate.
  • the barrier membrane for guided bone regeneration may further include a bio-ceramic layer obtained by coating a lower surface of the substrate with bio-ceramic.
  • the bio-ceramic layer may be formed by coating the lower surface of the substrate with a material selected from the group consisting of hydroxyapatite (HA), ⁇ -tricalcium phosphate ( ⁇ -TCP), bioglass, and gypsum by spraying the material onto the lower surface in high pressure.
  • the bio-ceramic layer may be made of a material selected from the group consisting of hydroxyapatite (HA), ⁇ -tricalcium phosphate ( ⁇ -TCP), bioglass, and gypsum, and the bio-ceramic layer may be attached to the lower surface of the substrate by using a polymer material having adhesive force with the selected material.
  • HA hydroxyapatite
  • ⁇ -TCP ⁇ -tricalcium phosphate
  • bioglass gypsum
  • the texture of the barrier membrane for guided bone regeneration according to the first aspect may include a plurality of protrusions and protruded pores, and the protruded pores may pass through the upper and lower surfaces of the substrate.
  • the substrate of barrier membrane for guided bone regeneration according to the above aspects may have the previously set thickness and strength by being rolled.
  • the barrier membrane for guided bone regeneration is constructed with a substrate made of silver, gold, or gold alloy. It is possible to secure biocompat ibi 1 ity, exclusion and sealing of cells, space maintenance, connectivity with tissues, and easiness of using the barrier membrane by forming a polymer layer and a bio-ceramic layer respectively on upper and lower surfaces of the substrate. In addition, it is possible to prevent a flow of soft tissues in a junction part with the soft tissues and minimize bursts of sutures due to shrinkage of tissues by forming texture including protrusions on the substrate according to an embodiment of the present invention. In addition, it is possible for blood to circulate by forming protruded pores on the substrate, thereby supplying blood to epithelium cells.
  • the barrier membrane for guided tissue regeneration may be used to induce regeneration of bone tissues for orthopedic or plastic surgery treatments, in addition to dental treatments. Accordingly, the barrier membrane for guided tissue regeneration may be used for various purposes.
  • FIG. 1 is a schematic diagram illustrating a structure of a barrier membrane for guided tissue regeneration according to a first embodiment of the present invention.
  • FIG. 2 is a schematic diagram illustrating a structure of a barrier membrane for guided tissue regeneration according to a second embodiment of the present invention.
  • FIG. 3 is a top plan view illustrating the barrier membrane for guided bone regeneration having protrusions and protruded pores according to the second embodiment of the present invention.
  • FIG. 4 includes cross sectional views taken along the directions A-A 1 and B-B' of the barrier membrane for guided tissue regeneration of FIG. 3.
  • FIG. 5 is a flowchart of an example of a procedure of manufacturing the barrier membrane for guided bone regeneration according to the second embodiment of the present invention. [Best Mode]
  • FIG. 1 is a schematic diagram illustrating a structure of a barrier membrane for guided bone and tissue regeneration according to a first embodiment of the present invention.
  • a barrier membrane 10 for guided bone and tissue regeneration according to the first embodiment is constructed with a substrate made of gold or silver having high purity so as to improve biocompat ibi lity and space maintenance or constructed with a substrate made of gold alloy obtained by adding an element such as platinum (Pt), palladium (Pel), silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like to gold so as to improve strength and functions.
  • Pt platinum
  • palladium (Pel) silver
  • Ag copper
  • Cu copper
  • Ir iridium
  • Zn zinc
  • rhodium (Rh), tin (Sn) tin
  • the substrate may have a previously set thickness through a rolling procedure. At this time, the previously set thickness may range from 0.015 to 0.15 mm.
  • the thickness of the substrate has to be equal to or greater than 0.015 mm so as to secure space maintenance of the barrier membrane.
  • the thickness of the substrate in order to remove foreign body sensation due to the barrier membrane, may be equal to or less than 0.15 mm. If the thickness of the substrate of the barrier membrane is greater than 0.15 mm, it is possible to secure space maintenance. However, it is not easy to insert the barrier membrane.
  • the barrier membrane may cause damage of soft tissues. In addition, a tongue may feel a foreign body under the soft tissues.
  • the barrier membrane according to the first embodiment of the present invention effectively induces regeneration of tissues of periodontal bone by further including a bio-ceramic layer under the substrate.
  • the lower surface of the substrate is coated with the bio- ceramic layer by spraying bio-ceramic onto the lower surface of the substrate in high pressure.
  • the bio-ceramic layer used for the barrier membrane according to the current embodiment may be made of a bio-ceramic material having a function of guiding regeneration of periodontal bone tissues, such as hydroxyapat ite (HA), ⁇ 3-tricalcium phosphate ( ⁇ -TCP), bioglass, gypsum, and the like.
  • the barrier membrane according to the first embodiment of the present invention may further include a polymer layer on the upper surface of the substrate.
  • the polymer layer is formed by coating the upper surface of the substrate with bio-polymer solution containing an antibiotic.
  • the antibiotic contained in the polymer layer suppresses an inflammation and a secondary infection which may occur after a surgical operation.
  • the antibiotic contained in the polymer layer of the barrier layer according to an embodiment of the present invention may be tetracycline.
  • FIG. 2 is a schematic diagram illustrating a structure of a barrier membrane for guided bone and tissue regeneration according to a second embodiment of the present invention.
  • FIGS. 3 and 4 include a top plan view and cross sectional views illustrating the barrier membrane according to the second embodiment of the present invention.
  • the barrier membrane 20 for guided bone regeneration includes a substrate 230, a polymer layer 240 containing an antibiotic, and a bio-ceramic layer 250.
  • the substrate 230 is made of gold or silver having high purity so as to improve biocompat ibi 1 ity and space maintenance or made of gold alloy obtained by adding an element such as platinum (Pt), palladium (Pd), silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like to gold so as to improve strength and functions.
  • an element such as platinum (Pt), palladium (Pd), silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like to gold so as to improve strength and functions.
  • FIG. 4 (a) is a cross sectional view taken along the direction A-A' illustrating the barrier membrane of FIG. 3, and (b) is a cross sectional view taken along the direction B-B 1 illustrating the barrier membrane of FIG. 3.
  • the substrate 230 has texture including a plurality of protrusions 200 and 210 and protruded pores 260.
  • the barrier membrane for guided bone and tissue regeneration according to the second embodiment prevents a flow of soft tissues in a junction part with the soft tissues by having the texture including hemispheric protrusions.
  • the barrier membrane according to the second embodiment enables blood to be supplied to epithelial cells by forming the protruded pores in the texture of the substrate.
  • the texture including a plurality of hemispheric protrusions is exemplified in the second embodiment, it will be understood by those skilled in the art that a plurality of cylindrical protrusions, a plurality of cone type protrusions, or a plurality of polygonal solid protrusions may be employed for the texture.
  • the substrate may have various types of texture in addition to the texture including the protrusions and the protruded pores.
  • the substrate may have texture including a plurality of through holes or texture including only protrusions.
  • the lower surface of the substrate is coated with the bio-ceramic layer 250 by spraying bio-ceramic onto the lower surface of the substrate in high pressure so as to guide regeneration of periodontal bone tissue.
  • the bio- ceramic layer used for the barrier membrane according to the second embodiment may be made of a bio-ceramic material having a function of guiding regeneration of periodontal bone tissue, such as hydroxyapat ite (HA), ⁇ - tricalcium phosphate ( ⁇ -TCP), bioglass, gypsum, and the Like.
  • the polymer layer 240 is formed by coating the upper surface of the substrate with bio-polymer solution containing an antibiotic.
  • the antibiotic contained in the polymer layer suppresses an inflammation and a secondary infection which may occur after a surgical operation.
  • the antibiotic contained in the polymer layer of the barrier layer according to an embodiment of the present invention may be tetracycline.
  • strength of the substrate 230 is increased by rolling the substrate 230 made of silver or gold having high purity or gold alloy containing an element such as platinum (Pt), palladium (Pd), silver (Ag), copper (Cu), iridium (Ir), zinc (Zn), indium (In), rhodium (Rh), tin (Sn), and the like by using a roller to a thickness ranging from 0.015 to 0.15 mm (operation 100) .
  • the substrate 230 has texture including hemispheric protrusions 210 and 200 and protruded pores 260 by pressing the substrate 230 (operation 110).
  • the texture is used to prevent a flow of soft tissues such as gingiva1.
  • TM> Hereinafter, the rolled substrate is cleansed by using an ultrasonic cleaner (operation 120).
  • the upper surface of the substrate having the texture 204 is spray-coated with polymer solution containing an antibiotic so as to form the polymer layer 240 containing the antibiotic on the upper surface of the substrate (operation 140).
  • the polymer solution containing the antibiotic is produced by mixing a solvent with polymers to produce polymer solution and mixing the polymer solution with an antibiotic such as tetracycline.
  • the bio-ceramic layer 250 is formed on the lower surface of the substrate 230 by spraying a bio-ceramic such as hydroxyapatite (HA), ⁇ -tricalcium phosphate ( ⁇ -TCP), bioglass, gypsum, and the like onto the lower surface of the substrate in high pressure and plasma-coating the lower surface of the substrate with the bio-ceramic (operation 150).
  • a bio-ceramic such as hydroxyapatite (HA), ⁇ -tricalcium phosphate ( ⁇ -TCP), bioglass, gypsum, and the like
  • the bio-ceramic may be attached by using an adhesive polymer material.
  • Any bio-polymer material may be used as the polymer material of for this case.
  • one of polylactide-co-glycolide (PLGA), poIy-L-lactic acid (PLLA), polyglycolide (PGA), Cyanoacrylate may be employed as the polymer material.
  • manufacturing of the barrier membrane for guided tissue regeneration according to the second embodiment is completed by forming the bio-ceramic layer 250 on the lower surface of the substrate.
  • the barrier membrane for guided bone and tissue regeneration may be used to induce regeneration of bone tissues in orthopedic or plastic surgery treatments, in addition to dental treatments. Accordingly, the barrier membrane for guided bone and tissue regeneration may be used for various purposes.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une membrane barrière pour la régénération osseuse guidée ainsi qu'un procédé de fabrication de ladite membrane. La membrane barrière pour la régénération osseuse guidée qui est constituée d'argent, d'or, ou d'alliage d'or comprend un substrat présentant une texture comportant des parties saillantes d'une forme prédéterminée, une couche polymère formée par revêtement d'une surface supérieure à l'aide d'une solution polymère, ainsi qu'une couche biocéramique formée par revêtement d'une surface inférieure du substrat. La membrane barrière pour la régénération osseuse guidée peut assurer une biocompatibilité, une exclusion et un scellement de cellules, le maintien d'espace, la connectivité avec les tissus, et la facilité d'utilisation de la membrane barrière qui sont requis pour la régénération osseuse/tissulaire guidée (GBR/GTR).
PCT/KR2008/001500 2007-03-26 2008-03-17 Membranes barrières pour régénération osseuse guidée Ceased WO2008117949A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US12/450,439 US20100028409A1 (en) 2007-03-26 2008-03-17 Barrier Membranes For Guided Bone Regeneration

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2007-0029058 2007-03-26
KR20070029058 2007-03-26
KR1020080023982A KR100970717B1 (ko) 2007-03-26 2008-03-14 골 조직재생유도용 차폐막
KR10-2008-0023982 2008-03-14

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WO2008117949A1 true WO2008117949A1 (fr) 2008-10-02

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PCT/KR2008/001500 Ceased WO2008117949A1 (fr) 2007-03-26 2008-03-17 Membranes barrières pour régénération osseuse guidée

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120065741A1 (en) * 2010-09-13 2012-03-15 Chao-Fu Chang Guided tissue regeneration membrane
CN101497003B (zh) * 2009-01-24 2012-07-04 大连理工大学 多功能光催化复合陶瓷分离膜及其制备方法和应用
WO2014102431A1 (fr) * 2012-12-24 2014-07-03 Servicio Andaluz De Salud Membrane réabsorbable pour régénération osseuse guidée
CN107551328A (zh) * 2017-10-31 2018-01-09 无锡中科光远生物材料有限公司 一种用于骨再生的抗菌和免疫调节的表面功能化静电纺丝膜的制备方法
CN109847108A (zh) * 2019-03-13 2019-06-07 北京大学口腔医学院 一种锌基合金引导性骨组织再生膜

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6143036A (en) * 1997-12-18 2000-11-07 Comfort Biomedical, Inc. Bone augmentation for prosthetic implants and the like
US20040121290A1 (en) * 2002-09-16 2004-06-24 Lynntech, Inc. Biocompatible implants
US20050107864A1 (en) * 2001-12-27 2005-05-19 James Hong Hybrid intravascular stent
KR20050048360A (ko) * 2003-11-19 2005-05-24 재단법인서울대학교산학협력재단 나노 섬유형 부직포를 이용한 조직 재생용 차폐막 및 그의제조 방법
US20060222844A1 (en) * 2005-04-04 2006-10-05 Stinson Jonathan S Medical devices including composites

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6143036A (en) * 1997-12-18 2000-11-07 Comfort Biomedical, Inc. Bone augmentation for prosthetic implants and the like
US20050107864A1 (en) * 2001-12-27 2005-05-19 James Hong Hybrid intravascular stent
US20040121290A1 (en) * 2002-09-16 2004-06-24 Lynntech, Inc. Biocompatible implants
KR20050048360A (ko) * 2003-11-19 2005-05-24 재단법인서울대학교산학협력재단 나노 섬유형 부직포를 이용한 조직 재생용 차폐막 및 그의제조 방법
US20060222844A1 (en) * 2005-04-04 2006-10-05 Stinson Jonathan S Medical devices including composites

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101497003B (zh) * 2009-01-24 2012-07-04 大连理工大学 多功能光催化复合陶瓷分离膜及其制备方法和应用
US20120065741A1 (en) * 2010-09-13 2012-03-15 Chao-Fu Chang Guided tissue regeneration membrane
WO2014102431A1 (fr) * 2012-12-24 2014-07-03 Servicio Andaluz De Salud Membrane réabsorbable pour régénération osseuse guidée
CN107551328A (zh) * 2017-10-31 2018-01-09 无锡中科光远生物材料有限公司 一种用于骨再生的抗菌和免疫调节的表面功能化静电纺丝膜的制备方法
CN107551328B (zh) * 2017-10-31 2021-03-05 无锡中科光远生物材料有限公司 一种用于骨再生的抗菌和免疫调节的表面功能化静电纺丝膜的制备方法
CN109847108A (zh) * 2019-03-13 2019-06-07 北京大学口腔医学院 一种锌基合金引导性骨组织再生膜

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