CN1249196A - Artificial material for repairing skull and its making method - Google Patents

Artificial material for repairing skull and its making method Download PDF

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Publication number
CN1249196A
CN1249196A CN 98120303 CN98120303A CN1249196A CN 1249196 A CN1249196 A CN 1249196A CN 98120303 CN98120303 CN 98120303 CN 98120303 A CN98120303 A CN 98120303A CN 1249196 A CN1249196 A CN 1249196A
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deck
resin
fine
close
corallium japonicum
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CN1096282C (en
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陶智潞
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Abstract

An artificial material with compound layer structure for repairing skull is prepared from hydroxy phosphorite, high-molecular adhesive and reinforcing fibres through manual coating or mechanical die press. Its advantages are simple preparing process, better breaking toughness and strength, no toxicity, no carcinogensis, high biocompatibility, low thermal conductivity and high impact strength.

Description

A kind of artificial material for repairing skull and manufacture method thereof
The invention belongs to medical prosthese composite, more particularly, is a kind of lamination layer structure material of artificial skull reparation usefulness.
At present, the frequent repair of cranial defects material that uses of medical institutions can divide substantially both at home and abroad: metal species such as titanium plate, titanium alloy sheet: non-metal kind such as bone cement, glass ceramics, silicone rubber, polyethylene from high pressure process, hydroxyapatite, lucite, fiberglass; From body bone or xenogenesis bone as from the body skull, the dissociate cattle ilium of composite tissue transplantation, deactivation of ilium anastomosis of blood vessel.Above-mentioned preceding two kinds and cattle ilium all belong to foreign body, though biocompatibility is arranged behind the implant into body, organize affinity but lack, can not satisfy the physiological requirement (CN1125144A) after the repair of cranial defects, as titanium plate and titanium alloy sheet easily absorb heat, heat conductivity is big, is harmful to cerebral tissue under daylight, titanium alloy sheet is magnetic, be an impediment to CT and magnetic resonance imaging inspection and radiotherapy, difficult forming, shock resistance is poor; Lucite is easily aging and crisp, easily causes local hydrops reaction (Chinese shaping burns unit, first phase nineteen ninety 24-26 page or leaf), organize affinity poor, but price is low, and molding is easy, draws materials with easy to use; Hydroxyapatite is because of having the advantage similar to people's bone component, there is the good compatibility to be subject to people's attention with human body with tangible affinity, but it exists difficult forming, shock resistance is poor, should not use separately, a kind of preparation method of biocompatibility composite is proposed as the CN1032423C patent, the base material that one deck glass monohydroxy apatite ceramic layer is arranged above it, at random in base material and layer, one deck intermediate glass layer is arranged, this method more complicated, the preparation base material needs to carry out under 400 ℃ of temperature; Also useful plasma spray is coated on the hard substrate uses (Chen Zhiqing compiles, oral cavity material science, People's Health Publisher, version in 1988), and this method need be used expensive spraying equipment, the essential anti-high temperature more than 3000 ℃ of employed base material, and its coating is very thin.The MMA monomer easily is absorbed by the body when being mixed with the bone cement use temporarily, cause blood pressure drops, if it is pre-formed, poor during use because of strain property in cutting out difficulty and performing the operation, be restricted in the use, fiberglass is because of there being glass fibre in the material, during material aging, glass fibre from crackle or tangent plane expose and stimulate local organization (CN1030523C).
The objective of the invention is to overcome the shortcoming of prior art, it is simple to propose a kind of manufacturing, and molding is easy, and compatible good to human body, shock resistance is strong, low-cost a kind of artificial material for repairing skull and preparation method thereof.
Realize purpose main technical schemes of the present invention: adopt to comprise hydroxyapatite or fine and close Corallium Japonicum Kishinouye, polymeric adhesive, reinforcing fiber materials, make composite bed.
The composition of artificial skull material of the present invention and content are 100 in the component sum): hydroxyapatite 5-10%, carbon cloth 5-15%, terylene 20-30%, macromolecule resin 50-70%.
Described macromolecule resin is a methyl methacrylate.
Described hydroxyapatite is the LM2040 type that Sichuan University provides, and main component is Ca 10(PO 4) 6(OH) 2, described Corallium Japonicum Kishinouye is angle, a Hainan Nidus Vespae Corallium Japonicum Kishinouye, its main component is CaCO 3Similar with the body bone tissue composition, price only is 0.1% of a hydroxyapatite, and processing also is easy to, only need with 5% liquor natrii hypochloritis's continuous dipping 3 times, each 1-2 days,, grind after the drying and promptly get fine and close Corallium Japonicum Kishinouye granule and powder with ion exchange water flush away organic matter.
The artificial skull preparation methods of wanting of the present invention may further comprise the steps:
1, at first be coated with one deck releasing agent on the polyethylene mould, spray one deck hydroxyapatite powder or fine and close Corallium Japonicum Kishinouye powder on its surface then, described releasing agent comprises silicone, polyvinyl alcohol;
2, at (1) step top layer time shop one deck dacron, be coated with one deck low viscosity resin;
3,, be coated with the low sticking bottom resin of one deck at (2) step top layer time shop one deck carbon cloth;
4, spreading one deck dacron repeatedly successively on (3) step top layer, be coated with one deck resin, is 2-3mm until thickness;
5, spray one deck hydroapatite particles or fine and close Corallium Japonicum Kishinouye granule at (4) step resin surface;
6, the composite bed that (5) is gone on foot the not demoulding solidified 2-4 hour at 80-90 ℃ then in 40 ℃ of following precuring 4 hours, and demoulding postcooling to room temperature promptly obtains semi-finished product;
7, (6) step semi-finished product are put into metal die,, press to and make resin solidification 2-3 hour, be cooled under 75-85 ℃, through punching, cut and promptly obtain finished product by taking out in the mould at 125-200 ℃ at 60-80 ℃ of following dress mould.
Described hydroxyapatite powder or fine and close Corallium Japonicum Kishinouye powder diameter 80-100 order, described hydroapatite particles or fine and close Corallium Japonicum Kishinouye particle diameter 0.3-0.9mm.
Described hole its objective is the fixing of artificial skull and skull hone lamella in helping performing the operation, and helps postoperative drainage, helps the affine of top layer and bottom hydroxyapatite and scalp connective tissue and artificial skull, and the spacing in hole is 2-3cm, aperture 0.3-0.5cm.
The fortifying fibre that the present invention is used except carbon fiber, terylene, also can adopt polypropylene and nylon.
Advantage of the present invention and effect:
The present invention is owing to adopt by hydroxyapatite or fine and close Corallium Japonicum Kishinouye, fortifying fibre, the composite bed that polymeric adhesive makes is as the artificial skull material, fracture toughness of its existing lucite and pliability, the activity that has hydroxyapatite again, through experiment confirm, good biocompatibility, foreign body reaction is light, no cytotoxicity, no carcinogenesis is to ethanol, new cleanly go out since then, povidone iodine, normal saline, blood plasma soaked 24 hours, the top layer no change, heat conductivity is low, and shock resistance is higher than lucite, nonmagnetic reaction is applicable to department of cerebral surgery under CT and the nuclear-magnetism, the traumatology department, jaw face and the damaged reparation of plastic surgery's flat bone.
Further specify characteristics of the present invention below by example.
Example 1
The raw material that this example is used: South Sea Corallium Japonicum Kishinouye powder (0.015mm) 0.2kg, particle diameter are the South Sea Corallium Japonicum Kishinouye granule 1.5kg of 0.3-0.9mm, the polymethyl methacrylate 54kg of carbon cloth 0.6kg, dacron 2.5kg, medical grade.
Concrete preparation process: at first be coated with one deck silicone, spread one deck Corallium Japonicum Kishinouye powder successively, shop one deck bar synthetic fibre fabric at the polyethylene die surface, be coated with one deck resin, shop one deck carbon cloth is coated with one deck resin, spread one deck terylene fabric then repeatedly successively, being coated with one deck resin, is 2mm until thickness, spreads one deck Corallium Japonicum Kishinouye granule at resin surface at last, obtain composite bed, composite bed solidified 3 hours down in 80 ± 5 ℃ in 40 ℃ of following precuring 4 hours again, naturally cooled to room temperature after the demoulding and was semi-finished product; Semi-finished product are put into the stainless steel metal mould, at 60 ± 5 ℃ of following dress moulds, suppress and make resin solidification under 150 ℃, slowly cooling is taken out in by mould under 75 ± 5 ℃, by pitch of holes 2cm, and aperture 0.4cm punching, stripping and slicing gets product again.End properties sees Table 1, and compares with lucite and fortifying fibre glass.
Example 2
The hydroxyapatite that the used raw material of this example provides for Sichuan University, its powder are the 0.3kg of 0.015mm and 1.4kg, carbon cloth 0.8kg, woven dacron 1.7kg, the methyl methacrylate 5.8kg that particle diameter is 0.4-0.9mm.Preparation process is with example 1.
Example 3
This example is a biological test.With reference to chief editors such as ASTMF1748-82, ISO/TR9966 (1988) and Yu Songting, " biology the basis of engineering in medicine and clinical ", Tianjin science tech publishing house, 1989, the method of P145 and regulation, example 1 and example 2 products are carried out tests such as heat source response, intradermal injection, sensitization of skin, systemic anaphylaxis, the stimulation of eye conjunctiva cornea, haemolysis, and compare observation with the lucite group simultaneously.Pathology confirms that material postoperative of the present invention 7 days and month inflammation and significant reaction are lower than the lucite group, organize affinity to be higher than the lucite group; Good biocompatibility, heat source response is 0.5 ℃, is lower than the positive criteria (1.4 ℃) of pharmacopeia regulation; Intradermal injection experiment no erythema, pimple or blister; Ripple skin sensitization experiment reaction is negative; The systemic anaphylaxis experiment is negative; Conjunctiva irritant reaction (one); The hemolytic experiment hemolysis rate is 1.5%, is lower than required standard (5%).The above results illustrates that the clinical use of product of the present invention is safe.
Table 1
Project Lucite Fortifying fibre glass Example 1 product
Brinell hardness, kg/cm 2 ????18 ????22 ????24
Impact strength, kg/cm 2 ????12 ????24 ????28
Tensile strength, kg/cm 2 ????550 ????650 ????700
Heat distortion temperature, ℃ ????95 ????101 ????100

Claims (6)

1, a kind of artificial material for repairing skull, it is characterized in that forming and comprise hydroxyapatite or fine and close Corallium Japonicum Kishinouye, fortifying fibre, macromolecule resin, specifically form and content (is 100 in the composition weight sum): hydroxyapatite 5-10%, carbon fibre fabric 5-15%, terylene 20-30%, macromolecule resin 50-70%.
2, according to the described material of claim 1, it is characterized in that described fortifying fibre, comprise terylene, carbon fiber, polypropylene, nylon.
3,, it is characterized in that described macromolecule resin is a methyl methacrylate according to the described material of claim 1.
4, the described preparation methods of claim 1 is characterized in that preparation process may further comprise the steps:
(1). be coated with one deck releasing agent at the polyethylene die surface, spray one deck hydroxyapatite powder or fine and close Corallium Japonicum Kishinouye powder then on its surface equably:
(2). spread one deck dacron successively on (1) step top layer, be coated with one deck resin;
(3) spread one deck carbon fibre fabric successively on (2) step top layer, be coated with one deck resin;
(4) spreading one deck terylene fabric repeatedly successively on (3) step top layer, be coated with one deck resin, is 2-3mm until thickness;
(5). spray one deck hydroapatite particles or fine and close Corallium Japonicum Kishinouye granule equably at (4) step resin surface;
(6). the composite bed that (5) is gone on foot the not demoulding solidified 2-4 hour at 80-90 ℃ then in 40 ℃ of following precuring 4 hours, and demoulding postcooling to room temperature promptly obtains semi-finished product;
(7). (6) step semi-finished product are put into metal die,, under 100-150 ℃, make resin solidification 2-3 hour, be cooled under 75-85 ℃, through punching, cut and promptly obtain finished product by taking out in the mould at 60-80 ℃ of following dress mould.
5, in accordance with the method for claim 4, it is characterized in that hydroxyapatite powder or fine and close Corallium Japonicum Kishinouye powder diameter 80-100 order, hydroapatite particles or fine and close Corallium Japonicum Kishinouye particle diameter 0.3-0.9mm.
6, in accordance with the method for claim 4, the pitch of holes that it is characterized in that finished product is 2-3cm, and the aperture is 0.3-0.5cm.
CN98120303A 1998-09-30 1998-09-30 Artificial material for repairing skull and its making method Expired - Fee Related CN1096282C (en)

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CN98120303A CN1096282C (en) 1998-09-30 1998-09-30 Artificial material for repairing skull and its making method

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Application Number Priority Date Filing Date Title
CN98120303A CN1096282C (en) 1998-09-30 1998-09-30 Artificial material for repairing skull and its making method

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CN1249196A true CN1249196A (en) 2000-04-05
CN1096282C CN1096282C (en) 2002-12-18

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110680559A (en) * 2019-09-27 2020-01-14 长沙晟天新材料有限公司 Chest lock integrated piece and preparation method thereof
CN112618790A (en) * 2021-01-18 2021-04-09 常州市武进人民医院 Brain surgery artificial skull repairing material and manufacturing method thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS63102762A (en) * 1986-10-20 1988-05-07 丸野 重雄 Living body compatible composite and its production

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110680559A (en) * 2019-09-27 2020-01-14 长沙晟天新材料有限公司 Chest lock integrated piece and preparation method thereof
CN112618790A (en) * 2021-01-18 2021-04-09 常州市武进人民医院 Brain surgery artificial skull repairing material and manufacturing method thereof

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