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WO2007128192A1 - Biocéramique médicale poreuse du type renforcé - Google Patents

Biocéramique médicale poreuse du type renforcé Download PDF

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Publication number
WO2007128192A1
WO2007128192A1 PCT/CN2007/001124 CN2007001124W WO2007128192A1 WO 2007128192 A1 WO2007128192 A1 WO 2007128192A1 CN 2007001124 W CN2007001124 W CN 2007001124W WO 2007128192 A1 WO2007128192 A1 WO 2007128192A1
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WIPO (PCT)
Prior art keywords
porous
mold
medically
dense
ceramic
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Ceased
Application number
PCT/CN2007/001124
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English (en)
Chinese (zh)
Inventor
Jianxi Lu
Jiang Chang
Zhen Wang
Kaili Lin
Faming Zhang
Jian Tang
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    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B38/00—Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof
    • C04B38/06—Porous mortars, concrete, artificial stone or ceramic ware; Preparation thereof by burning-out added substances by burning natural expanding materials or by sublimating or melting out added substances
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/10—Ceramics or glasses
    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2111/00—Mortars, concrete or artificial stone or mixtures to prepare them, characterised by specific function, property or use
    • C04B2111/00474—Uses not provided for elsewhere in C04B2111/00
    • C04B2111/00836—Uses not provided for elsewhere in C04B2111/00 for medical or dental applications

Definitions

  • the invention relates to a medical enhanced porous bioceramic, a preparation method and an application thereof, and the product prepared by the process can be applied to the field of biomedicine, especially orthopedics, plastic surgery, maxillofacial surgery, ENT, brain surgery In other fields, the bone defect and anatomical repair and reconstruction, the product can also be applied to liquid filtration, gas purification, solid separation, industrial catalysis and other fields. Background technique
  • Bioceramics are medically intended for defect repair and reconstruction of human tissue.
  • the bone supply and bone supply are extremely limited in autologous bone transplantation, and the risk of potential disease transmission from bio-products (allogene and xenogenic bone)
  • bio-products allogene and xenogenic bone
  • Other factors have greatly promoted the research and application of bioceramics.
  • calcium phosphate bioceramics hydroxyapatite and tricalcium phosphate
  • Bioceramics are classified according to porosity, including porous and dense bioceramics, which have been widely used in the medical field.
  • dense bioceramics have good mechanical properties, can support and support, but because it does not have microstructures suitable for tissue and cell growth, its organisms Learning properties: such as biodegradability, osteoconductivity, etc.
  • porous ceramics although it has a good microporous structure, has good biological properties, but its mechanical properties are poor, can not be stressed parts
  • the organ plays a good supporting role, so the porous bioceramic can only be used as a tissue growth conductive material for the filling material and the non-load bearing portion.
  • the present invention intends to focus on the breakthrough at this point, the purpose of which is to combine the two forms of materials together to make a corresponding anatomical structure for bone defect repair and reconstruction of the anatomical structure, so that the dense part supports Role and tissue guiding of the porous part.
  • the two materials are the same chemical composition, due to the difference in structure and specific surface area, there is a significant difference in the degree of degradation.
  • the porous part can be replaced and degraded by tissue during half a year to one year, while the dense part It can last for more than two years and plays a good supporting role.
  • bioceramic that is dense and porous, i.e., a reinforced porous bioceramic.
  • the bioceramic contains two parts, porous and dense, the dense part acts to enhance the mechanical strength, and the porous part promotes the growth of cells and tissues into the ceramic.
  • Another object of the present invention is to provide a plurality of methods for preparing a reinforced porous bioceramic which can be adjusted by determining the size of the dense portion according to the requirements of the mechanical strength of the human bone repair portion to prepare a corresponding ceramic.
  • Another object of the present invention is to provide the above-mentioned application of the enhanced porous bioceramic in the field of biomedicine, especially for the repair and reconstruction of bone defects and organ reconstruction, in orthopedics, orthopedics, maxillofacial surgery, ENT, brain Applications in surgery, etc., can also be applied in industrial fields such as liquid filtration, gas purification, separation of solids, and industrial catalysis. Summary of invention
  • the medically enhanced porous bioceramic according to the present invention contains two parts, a dense and a porous one.
  • the dense part mainly plays a role in increasing the mechanical strength, and the porous part mainly serves as a guiding function for the growth of cells and tissues, and can be vascularized to obtain sufficient blood supply nutrition, so that the new tissue forms a corresponding function.
  • the medically-enhanced porous ceramics according to the present invention can determine the size of the dense portion by formula calculation according to the requirements of the mechanical strength of the human bone repairing portion to prepare a corresponding enhanced bioceramic.
  • the anatomical shape and size of the medically enhanced porous bioceramic according to the present invention are completely matched with the defect repairing portion. It can be used to inverse the X-ray and CT scan data of the contralateral anatomy, to create an anatomical model and the corresponding mold, so that the fabricated product matches the anatomical shape and size of the repair site (Fig. 1).
  • the porous microstructure of the medically-enhanced porous bioceramic according to the present invention can be made according to the characteristics of cells and tissue types and growth requirements, and the corresponding pore shape, porosity, pore size and inner diameter, and porous pore size.
  • the ratio is 50 to 1000 ⁇ m
  • the porosity is 50% to 85%
  • the inner diameter of the pores is 20 to 500 ⁇ m
  • the pore communication rate is 10% to 100%.
  • the dense portion of the medically-enhanced porous bioceramic according to the present invention is a ceramic reinforcement, which can be changed by changing the shape and volume of the reinforcement, or by controlling the production sintering temperature to change the amount ( ⁇ 10 ⁇ ).
  • the mechanical strength of the reinforced bioceramic is 2 to 200 times higher than that of the single porous bioceramic (Fig. 2), and the microporosity is 0.1% to 20%.
  • the reinforcement of the medically-reinforced porous bioceramic according to the present invention must be distributed at the force receiving portion to support the force and protect the porous portion.
  • the medically enhanced porous bioceramic reinforcement according to the present invention may be in the form of a cylinder, an elliptical cylinder, a square cylinder, a triangular cylinder, and an irregular cylinder (Fig. 3-6).
  • the reinforcement distribution is edge-type at the edge (Fig. 5-6), centered at the center (Fig. 3-4), and two or more reinforcements are dispersed (Fig. 7-12).
  • the arrangement of the reinforcements can be: longitudinal (Fig. 3-10), lateral (Fig. 12), oblique (Fig. 11), cross (Fig. 11) and mixed
  • the number of reinforcements can be from 1 to 20 (Fig. 7-12), and the amount of reinforcement in the entire ceramic volume is from 10% to 90%.
  • the ceramic powder raw material used for preparing the reinforced porous bioceramic according to the present invention has a grain size of 1.0 nm to 100 ⁇ m, and may be pure micron (0.1- ⁇ m) or pure nano-powder ( ⁇ 100 nm). It can be a mixture of nano and micro powders.
  • the chemical composition of the powder is selected from biologically active, such as from pure hydroxyapatite or doped hydroxyapatite, pure tricalcium phosphate or doped tricalcium phosphate, hydroxyapatite/tricalcium phosphate two-phase composite ceramic powder, Pure calcium carbonate or doped calcium carbonate, pure or doped alumina, pure zirconia or doped zirconia, titania, aluminum-magnesium spinel, and mixed powders in different ratios between the above various components.
  • biologically active such as from pure hydroxyapatite or doped hydroxyapatite, pure tricalcium phosphate or doped tricalcium phosphate, hydroxyapatite/tricalcium phosphate two-phase composite ceramic powder, Pure calcium carbonate or doped calcium carbonate, pure or doped alumina, pure zirconia or doped zirconia, titania, aluminum-magnesium spinel, and mixed powders in different ratios between the above various components.
  • the bioceramic can be applied in the field of biomedicine, especially in the fields of orthopedics, orthopedics, maxillofacial surgery, ENT, brain surgery, etc., for the repair and reconstruction of bone defects and anatomical structures, and also for liquid filtration and gas. Purification, solid separation, industrial catalysis and other fields.
  • the medically-reinforced porous bioceramic described above may be formed by co-molding, compression molding or molding.
  • the principle of grouting is to reserve a gap when making a ceramic organic porous support, and then the slurry is dried and formed. After the shaped body is sintered, the stent portion is removed to form a porous portion, and the reserved gap is formed by the infusion filling portion to form a dense reinforcement.
  • Molding is carried out by first forming a dense or porous portion by molding, and then making another matching portion around the portion.
  • the volume of the reinforcement can be arbitrarily designed; or the volume of the reinforcement can be determined by formula calculation.
  • the calculation formula of the volume volume of the reinforcing body in the invention :
  • Sd the cross-sectional area of the dense reinforcement in the ceramic
  • ⁇ Constant 1 to 4, which is related to the desired mechanical property improvement factor and the original powder grain size of the reinforced portion.
  • the desired mechanical property improvement ratio is more than 20 times
  • the ⁇ value generally takes 1 and is less than 20 Take 3 to 4 times
  • the original powder of the reinforced part is nanometer ( ⁇ 100nm)
  • ⁇ has a larger value
  • the micron powder ⁇ has a smaller value.
  • the reinforced ceramic can be formed by co-molding, compression molding or molding by injection molding. ⁇ , grouting
  • the dried organic framework was placed in a correspondingly sized mold, and then the prepared slurry was poured, and after 1 to 5 hours, the green body was demolded to form a green body, which was dried in a dry box for 12 hours.
  • the selected organic pore-forming agent and the ceramic powder are uniformly mixed in a certain ratio, and then filled into the selected mold cavity, and the mold plug body is pressed for several minutes, and then the porous body is taken out by demoulding.
  • the ceramic powder is filled into the selected mold cavity, and after the mold plug is pressed for a few minutes, the compact body is taken out.
  • c. Prepare the ceramic powder and water in a certain ratio, and stir for 1 to 10 hours to form a fluid slurry.
  • d. The slurry is directly poured into the organic framework and dried in a dry box for several hours to form a porous dense composite body.
  • step 3) Put the above-mentioned step 3) the dried organic framework into a sintering furnace, gradually heat up to 200 ° C to 400 ° C to gasify and eliminate organic matter, and then continue to heat up to 1000 ° C - 1400 ⁇ sintering into the desired Enhanced porous bioceramics.
  • regular and irregular plastic particles which can be dissolved by an organic solvent and heat are selected as materials for making a porous scaffold.
  • Preferred plastic particle raw materials are olefin polystyrene, polyethylene, polypropylene, polyvinyl chloride, polyamide. , polyurethane, polymethyl methacrylate, paraffin and naphthalene, etc., which burn at high temperatures without leaving any harmful substances.
  • the hot melt point of the plastic particles should be between 100 ° C and 400 ° C.
  • the plastic particles are between 100 and 1000 microns in diameter.
  • the organic solvent may be selected from acetone, diacetone, bromochloromethane, methyl isobutyl ketone, chloroform or the like according to the plastic particle component.
  • the binder should be selected from particles which adhere to the above raw materials.
  • the mold material is not particularly limited and may be made of a material which is chemically inert to the solvent to be used, such as stainless steel, ceramics, glass, gypsum or the like.
  • the mold must have one or more feed ports.
  • the mold body must be in the form of a longitudinal pair or a multi-part body, and the joints between the parts should be very close. This facilitates the release of the porous frame.
  • Figure 1 is a photograph of a femoral head of a reinforced porous bioceramic made according to an anatomical model mold
  • Figure 2 is a comparison of mechanical properties of reinforced porous bioceramics and non-reinforced porous bioceramics
  • Figure 3 is a schematic view of a centrally-reinforced porous bioceramic, the cylindrical ceramic center is a cylindrical dense portion, and the edge is a porous portion;
  • Figure 4 is a schematic view of a central type of enhanced porous bioceramic, the central portion of the cylindrical ceramic is a rectangular parallelepiped portion, and the edge is a porous portion;
  • Figure 5 is a schematic view of an edge-type enhanced porous bioceramic, the central portion of the cylindrical ceramic is a porous portion of a polygonal columnar body, and the edge is a dense portion;
  • Figure 6 is a schematic view of an edge type reinforced porous bioceramic, the central portion of the cylindrical ceramic is a porous portion of a triangular columnar body, and the edge is a dense portion;
  • Figure 7 is a schematic view of a dispersion-type enhanced porous bioceramic, the cylindrical ceramic has a dense portion at the center and the periphery, and the annular body between the two is a porous portion;
  • Figure 8 is a schematic view of a dispersion-type enhanced porous bioceramic, the cylindrical ceramic porous portion is equidistantly distributed with six cylindrical compacts of uniform size, and a dense body of a peripherally annularly wrapped porous portion;
  • Figure 9 is a schematic view of a dispersion-type enhanced porous bioceramic, the cylindrical ceramic porous portion is equidistantly distributed with eight cylindrical compacts of uniform size;
  • Figure 10 is a schematic view of a dispersion-type enhanced porous bioceramic, wherein the cylindrical ceramic dense portion is equidistantly distributed with six cylindrical porous bodies of uniform size;
  • Figure 11 is a schematic view of a dispersion-enhanced porous bioceramic, wherein the cubic ceramic multi-part L is equidistantly distributed with five diagonally oblique cylindrical compacts of uniform size;
  • Figure 12 is a schematic view of a dispersion-type enhanced porous bioceramic, wherein the cubic ceramic multi-part L is equidistantly distributed with five longitudinal and five transversely aligned cylindrical compacts;
  • Figure 13 is a scanning electron micrograph of the interface between the dense and porous portions of the reinforced porous bioceramic
  • Figure 14 is a photograph of the edge-type enhanced porous bioceramic
  • FIG. 15 is a photograph of a central enhanced porous bioceramic.
  • the edge-type reinforced porous bioceramic produced by the grouting process uses tricalcium phosphate as the raw material (the powder shrinkage rate is 15%), and the cylinder with a diameter of 18 mm and a height of 20 mm is required to achieve the resistance of 70 MPa.
  • the compressive strength, and the porosity of the porous portion was 70%, the pore diameter was 500 - 600 ⁇ m, and the pore diameter was 120 ⁇ m.
  • the compressive strength of the porous portion was 2.0 MPa.
  • the enhancement range is 35 times, tricalcium phosphate is a micron powder, n is taken 1, and thus
  • the actual porous portion has a diameter of 9.45 mm and the reinforcement has a thickness of 5.62 mm.
  • the central reinforced porous bioceramic produced by the compression molding process uses tricalcium phosphate as a raw material (15% powder shrinkage) to produce a cylinder with a diameter of 20 mm and a twist of 20 mm.
  • the product is required to have an anti-40 MPa resistance.
  • the compressive strength, and the porosity of the porous portion was 70%, the pore diameter was 500 - 600 ⁇ m, and the pore diameter was 120 ⁇ m.
  • the compressive strength of the porous portion was 2.0 MPa.
  • the enhancement range is 20 times, the tricalcium phosphate is a micron powder, n is taken 1, and thus
  • the actual reinforcing portion has a diameter of 13.29 mm and the porous portion has a thickness of 4.85 mm.
  • the edge-type reinforced porous bioceramic produced by the molding-slurry co-forming process uses tricalcium phosphate as a raw material (15% powder shrinkage) to produce a cylinder with a diameter of 30 mm and a height of 30 mm.
  • the compressive strength of 20 MPa, and the porosity of the porous portion is 70%, the pore diameter is 500 - 600 ⁇ m, and the pore diameter is 120 ⁇ m.
  • the compressive strength of the porous portion was 2.0 MPa.
  • the enhancement is more than 10 times, the tricalcium phosphate is a micron powder, n is taken 1, and thus
  • the actual porous portion has a diameter of 24.10 mm and the reinforcement has a thickness of 5.20 mm.
  • the dispersion-enhanced porous bioceramic produced by the grouting process uses tricalcium phosphate as a raw material (the powder shrinkage rate is 15%) to produce a cylinder having a diameter of 60 mm and a height of 40 mm, and contains eight cylindrical reinforcements.
  • the product is required to achieve a compressive strength of 30 MPa, and the porous portion has a porosity of 70%, a pore diameter of 500 to 600 ⁇ m, and a pore diameter of 120 ⁇ m.
  • the compressive strength of the porous portion was 2.0 MPa. Specific steps are as follows:
  • the enhancement range is more than 15 times, the tricalcium phosphate is a micron powder, n is taken 1, and thus,

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Compositions Of Oxide Ceramics (AREA)

Abstract

L'invention concerne une biocéramique médicale poreuse du type renforcé, et son procédé de préparation et d'application. La biocéramique est composée de deux parties de structure poreuse et de structure dense. On utilise essentiellement la partie de structure dense pour augmenter la résistance mécanique, la partie de structure poreuse présentant essentiellement une capacité d'interposition de cellules et de tissu et conférant au tissu nouvellement formé une fonction correspondante. On peut régler la forme des pores, la porosité, la taille des pores et la dimension d'une connexion intérieure en fonction de types de cellule et de tissu et d'exigences de croissance. La résistance de la partie dense peut être de 2 à 20 fois supérieure à celle d'une biocéramique poreuse pure en fonction d'une quantité ajoutée. L'invention concerne également un procédé de préparation mettant en oeuvre un processus de coulée en barbotine, un processus d'estampage et un processus de coulée en barbotine et d'estampage permettant de réaliser une biocéramique poreuse du type à dispersion centre-bord. On obtient ainsi une biocéramique présentant une forme, une dimension, une résistance mécanique et une fonction correspondant à celles d'un os humain à restaurer.
PCT/CN2007/001124 2006-04-26 2007-04-06 Biocéramique médicale poreuse du type renforcé Ceased WO2007128192A1 (fr)

Applications Claiming Priority (2)

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CN200610026058.9 2006-04-26
CNB2006100260589A CN100540071C (zh) 2006-04-26 2006-04-26 医用增强型多孔生物陶瓷及其制备方法

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CN103462729A (zh) * 2012-06-07 2013-12-25 中南大学 一种多级[微米/纳米]孔结构的仿生人工骨的制备方法
CN116969775A (zh) * 2023-08-01 2023-10-31 西安交通大学 一种用于人工髋关节的多孔/致密复合结构氮化硅材料及制备方法
CN118125815A (zh) * 2024-01-03 2024-06-04 瑞安市人民医院 一种涂层增强多孔生物陶瓷及制备方法

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CN102113924A (zh) * 2009-12-31 2011-07-06 北京爱康宜诚医疗器材股份有限公司 髋臼骨缺损填充体
CN103182099B (zh) * 2011-12-31 2015-02-18 深圳兰度生物材料有限公司 一种多孔活性人工骨及其制备方法
CN105330285B (zh) * 2015-12-11 2019-02-05 华南协同创新研究院 一种3D打印用ZrO2增韧生物活性陶瓷粉体材料及其制备和应用
CN108264373A (zh) * 2018-02-06 2018-07-10 付主枝 医用增强型多孔生物陶瓷材料的制备方法
CN109172050A (zh) * 2018-09-21 2019-01-11 广州市健齿生物科技有限公司 一种生物实验内部可填充复合物的多孔钛片及其制备方法
KR20220130097A (ko) 2019-11-27 2022-09-26 모트 코포레이션 세라믹 디스크 및 로드, 그 제조 방법 및 이를 포함하는 물품
CN110882417B (zh) * 2019-12-20 2021-02-19 上海贝奥路生物材料有限公司 复合多孔生物陶瓷的金属假体及其制备方法
CN115959928B (zh) * 2023-02-02 2024-01-26 卢建熙 一种股骨头坏死功能重建多孔生物陶瓷棒及其制备方法和应用

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CN103462729A (zh) * 2012-06-07 2013-12-25 中南大学 一种多级[微米/纳米]孔结构的仿生人工骨的制备方法
CN103462729B (zh) * 2012-06-07 2016-06-01 中南大学 一种多级[微米/纳米]孔结构的仿生人工骨的制备方法
CN116969775A (zh) * 2023-08-01 2023-10-31 西安交通大学 一种用于人工髋关节的多孔/致密复合结构氮化硅材料及制备方法
CN118125815A (zh) * 2024-01-03 2024-06-04 瑞安市人民医院 一种涂层增强多孔生物陶瓷及制备方法

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CN100540071C (zh) 2009-09-16

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