CN105310802B

CN105310802B - Artificial intervertebral disk and preparation method thereof

Info

Publication number: CN105310802B
Application number: CN201410243490.8A
Authority: CN
Inventors: 谭荣伟
Original assignee: SHENZHEN LANDO BIOMATERIALS CO Ltd
Current assignee: SHENZHEN LANDO BIOMATERIALS CO Ltd
Priority date: 2014-06-03
Filing date: 2014-06-03
Publication date: 2017-09-19
Anticipated expiration: 2034-06-03
Also published as: CN105310802A

Abstract

A kind of artificial intervertebral disk, including the first soleplate and the second soleplate, the first soleplate include the first wearing layer and the first repair layer of stacking, and the first reparation elementary layer and second that the first repair layer includes stacking repairs elementary layer；Second soleplate includes the second wearing layer and the second repair layer of stacking, and the 3rd reparation elementary layer and the 4th that the second repair layer includes stacking repairs elementary layer；The material of the material of first wearing layer and the second wearing layer is polyether-ether-ketone and the mixture of reinforcing fiber, the material and the 3rd material for repairing elementary layer of first reparation elementary layer are polyether-ether-ketone and the mixture of the first degradable active bone repair material, and second, which repairs the material of elementary layer and the 4th material for repairing elementary layer, includes the mixture of polyether-ether-ketone and the second degradable active bone repair material.There is the longer life-span after above-mentioned artificial intervertebral disk implantation human body.In addition, also providing a kind of preparation method of artificial intervertebral disk.

Description

Artificial intervertebral disk and preparation method thereof

Technical field

The invention belongs to biology medical material technical field, more particularly to a kind of artificial intervertebral disk and preparation method thereof.

Background technology

Cervical spondylopathy and lumbar vertebra disease are one kind due to spine disorderses caused by intervertebral disk retrogression lesion, it has also become notable shadow Ring the common disease of the elderly's quality of life and high morbidity.Wherein, in terms of lumbar vertebra disease, protrasion of the lumbar intervertebral disci total incidence is Up to 15.2~30%, and China lumbar vertebrae patient has broken through 200,000,000 at present, and 80% adult had pain in the back medical history.Clinical statisticses Show, the age is more than 50 years old person 40% has limitation of activity situation with upper lumbar spine, wherein 60% can produce lumbal vertebra, pressuring nerve There is illness in system, and about 10%-15% patient eventually develops into spinal compression, so as to cause paraplegia.And cervical spondylopathy Aspect more allows of no optimist, with aging population, it is long-term bend over the desk to take place frequently in face of computer increase and traffic accident, the cervical spine injury caused by Year increase, the cervical spondylopathy incidence of disease quickly rises.Current China incidence of disease accounts for the 7%-10% of country's total population, wherein 50 years old left side Right crowd's incidence of disease has exceeded 25%, and 60~70 years old incidence of disease may be up to 50%, and middle-young patients are sharply increased in addition, 30 years old with Lower adolescent patients have accounted for the 11% of total number of patients.

The treatment of intervertebral disc degeneration disease has two methods of operation and No operation.Non-operative treatment is only capable of relief of symptoms, no It can effect a radical cure, the patient of significant proportion must be treated surgically.In clinic, due to spinal fusion instant effect, good effect, operation Simple the advantages of, once turn into " goldstandard " of disc disease operative treatment for many years.But this operative treatment is still suffered from Some are regretted, and fusion can cause the physiological activity degree of lesion segment to be lost, adjacent segment motion and load increase, will be certain Accelerate Adjacent segment degeneration in degree.Clinical research finds that post-fusion has in about 25.6% patient 10 years after surgery and occurred Neighbouring section secondary affection.Up in the follow-up of 21 years, 14% patient need to perform the operation again.To solve the shakiness after decompression, Disc height is maintained, and retains the appropriate physiological activity of vertebra internode, is inspired by hip replacement, artificial disc replacement (TDR) arise at the historic moment.Compared with anterior cervical spine fusion and lumbar vertebra posterior-path fusion art, TDR, which has, keeps operated level normally to live The advantages of moving degree and stability, improve pressure in neighbouring intervertenral space, reduction neighbouring section neopathy rate, it is considered to be most have development The spinal biomechanicses reconstruction technique of prospect.And the artificial neck or lumber ertebral disc that TDR is used, then ground in the nature of things as the world Study carefully the emphasis and focus of exploitation.

Carry out the existing nearly 20 years history of TDR operations, existing a large amount of clinical cases, but regrettably used product in the country All imports.However, with the fast development of backbone non-fusion technology, TDR's becoming increasingly popular and being widely recognized as, compatriots' neck waist The incidence of disease of vertebra disease persistently rises, and the artificial intervertebral disk product for developing production domesticization is imperative.And the artificial intervertebral disk that domesticizes Exploitation mainly face following technological challenge：After interverbebral disc implantation human body, prosthese is closed under the complicated mechanics/physiological environment of human body There is heavy wear in nodal section material, produces a large amount of abrasive dusts, and various wear particles induce inflammatory reaction, cause Periprosthetic bone molten , finally there is prosthetic loosening, causes prosthese life-span wretched insufficiency in solution.

The content of the invention

In consideration of it, being necessary to provide a kind of artificial intervertebral disk for being implanted into and there is longer life after human body.

In addition, also providing a kind of preparation method of artificial intervertebral disk, after artificial intervertebral disk implantation human body prepared by this method With the longer life-span.

A kind of artificial intervertebral disk, including：

First soleplate, includes the first wearing layer and the first repair layer of stacking, first wearing layer is away from described first The side of repair layer is formed with arc convex, and first repair layer includes the first of stacking and repairs elementary layer and the second reparation list First layer, the second reparation elementary layer is laminated on first wearing layer；And

Second soleplate, is arranged on first soleplate, and second soleplate relative can be slided with first soleplate, institute Stating the second soleplate includes the second wearing layer and the second repair layer of stacking, and second wearing layer is away from second repair layer Side is formed with arc-shaped concave, and the arc convex slides against with the arc-shaped concave, and second repair layer includes layer Folded the 3rd repairs elementary layer and the 4th repairs elementary layer, and the 4th reparation elementary layer is laminated on second wearing layer；

Wherein, the material of the material of first wearing layer and second wearing layer is polyether-ether-ketone and reinforcing fiber Mixture, described first, which repairs the material of elementary layer and the described 3rd material for repairing elementary layer, includes polyether-ether-ketone and can The material of first active bone repair material of degraded, the material of the second reparation elementary layer and the 4th reparation elementary layer is equal For polyether-ether-ketone and the mixture of the second degradable active bone repair material, first active bone repair material is to be lured containing bone The microballoon or first active bone repair material of inducement are by hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, sulphur The mixture sodium chloride composition of at least one of sour calcium and bioactivity glass and microballoon composition containing bone-inducing factor it is mixed Compound, second active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and biology At least one of activity glass.

In one of the embodiments, first wearing layer includes multiple the first wear-resistant elements layers stacked gradually, many The material of the individual first wear-resistant elements layer is the mixture of the polyether-ether-ketone and the reinforcing fiber, resistance to from described first Grind the weight/mass percentage composition for the reinforcing fiber that the side of layer is arrived in opposite side, the material of the multiple first wear-resistant elements layer Gradually decrease, the second reparation elementary layer is laminated in minimum described first resistance to of the weight/mass percentage composition containing the reinforcing fiber Grind on elementary layer, the arc convex is formed at the described first most wear-resisting list of the weight/mass percentage composition containing the reinforcing fiber On first layer；

Second wearing layer includes multiple the second wear-resistant elements layers stacked gradually, multiple second wear-resistant elements layers Material be the polyether-ether-ketone and the reinforcing fiber mixture, the side from second wearing layer to opposite side, The weight/mass percentage composition of the reinforcing fiber in the material of the multiple second wear-resistant elements layer is gradually decreased, and the described 4th repaiies Multiple elementary layer is laminated on minimum second wear-resistant elements layer of the weight/mass percentage composition containing the reinforcing fiber, the arc Concave surface is formed on most second wear-resistant elements layer of the weight/mass percentage composition containing the reinforcing fiber.

In one of the embodiments, first wear-resistant elements of weight/mass percentage composition at most containing the reinforcing fiber In the material of layer, the mass ratio of the reinforcing fiber and the polyether-ether-ketone is 0.1:1~0.5:1；

In the material of most second wear-resistant elements layer of weight/mass percentage composition containing the reinforcing fiber, the enhancing The mass ratio of fiber and the polyether-ether-ketone is 0.1:1~0.5:1.

In one of the embodiments, first wear-resistant elements of weight/mass percentage composition at most containing the reinforcing fiber The thickness of layer is 50 microns~100 microns；

The thickness of most second wear-resistant elements layer of weight/mass percentage composition containing the reinforcing fiber for 50 microns~ 100 microns.

In one of the embodiments, the second reparation elementary layer is multiple, and multiple second reparations elementary layers are successively It is laminated on first wearing layer, the side from first repair layer is to opposite side, and the multiple second repairs elementary layer Material in the weight/mass percentage composition of second active bone repair material gradually decrease, containing the described second active Bone Defect Repari material Minimum the second reparation elementary layer of the weight/mass percentage composition of material is laminated on first wearing layer；

Described 4th repairs elementary layer to be multiple, and multiple four reparations elementary layers are stacked gradually in second wearing layer On, from the side of second repair layer to opposite side, the multiple 4th repairs second work in the material of elementary layer The weight/mass percentage composition of property bone renovating material is gradually decreased, and the weight/mass percentage composition containing second active bone repair material is minimum It is described 4th reparation elementary layer be laminated on second wearing layer.

In one of the embodiments, the reinforcing fiber is selected from carbon fiber, glass fibre, graphite fibre, carborundum fibre At least one of dimension, stainless steel fibre and titanium-base crystal whisker fiber.

In one of the embodiments, a diameter of 1 nanometer~50 microns of the reinforcing fiber, length be 10 microns~ 1000 microns.

In one of the embodiments, the particle diameter of the polyether-ether-ketone is less than 40 microns.

In one of the embodiments, the grain of first active bone repair material and second active bone repair material Footpath is 100 microns~1 millimeter.

A kind of preparation method of artificial intervertebral disk, comprises the following steps：

Reinforcing fiber is mixed with polyether-ether-ketone, the first mixed material is obtained；

First additive is mixed with polyether-ether-ketone, the first mixing material is obtained, first additive be sodium chloride or First additive described in person is in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass The mixture that at least one and sodium chloride is constituted；

Degradable active bone repair material is mixed with polyether-ether-ketone, the second mixing material is obtained；

The first mould is provided, first mould has the lower arcuate surface of evagination, by first mixed material, described Two mixing materials and first mixing material are sequentially added in first mould, after shaping, remove first mould, warp Sintering, first stacked gradually repairs elementary layer carcass, second repairs elementary layer and the first wearing layer, and described first resistance to Side of the mill layer away from the described second reparation elementary layer is formed with arc convex；

Cleaning removes the sodium chloride on the described first surface for repairing elementary layer carcass, then will contain bone-inducing factor Microballoon be adsorbed to it is described first repair elementary layer carcass on formed first repair elementary layer, obtain the first soleplate；

Reinforcing fiber is mixed with polyether-ether-ketone, the second mixed material is obtained；

Second addition is mixed with polyether-ether-ketone, the 3rd mixing material is obtained, the Second addition be sodium chloride or Second addition described in person is in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass The mixture that at least one and sodium chloride is constituted；

Degradable active bone repair material is mixed with polyether-ether-ketone, the 4th mixing material is obtained, wherein, described second Active bone repair material in mixing material and the 4th mixing material is selected from hydroxyapatite, type alpha tricalcium phosphate, β-phosphorus At least one of sour DFP, calcium sulfate and bioactivity glass；

The second mould is provided, second mould has the lower arcuate surface of indent, by second mixed material, described Four mixing materials and the 3rd mixing material are sequentially added in second mould, after shaping, remove second mould, warp Sintering, the 3rd stacked gradually repairs elementary layer carcass, the 4th repairs elementary layer and the second wearing layer, and described second resistance to Side of the mill layer away from the described 4th reparation elementary layer is formed with arc-shaped concave, and the arc convex can with the arc-shaped concave Slide against；And

Cleaning removes the sodium chloride on the described 3rd surface for repairing elementary layer carcass, then will contain bone-inducing factor Microballoon be adsorbed on the second repair layer carcass with formed the 3rd repair elementary layer, obtain the second soleplate.

After above-mentioned artificial intervertebral disk is implanted into human body, pass through the arc convex and the arc-shaped concave of the second soleplate of the first soleplate Slide against, to realize the relative slip of the first soleplate and the second soleplate, and the first soleplate of above-mentioned artificial intervertebral disk includes layer Folded the first wearing layer and the first repair layer, and the second soleplate includes the second wearing layer and the second repair layer of stacking, and first The material of the material of wearing layer and the second wearing layer is polyether-ether-ketone and the mixture of reinforcing fiber, and arc convex is located at the On one wearing layer, arc-shaped concave is located on the second wearing layer so that arc convex is respectively provided with preferable wearability with arc-shaped concave Can, abrasion loss amount is about 0.05~0.4mg/MC (MC represents million circulations), i.e., wear rate is to use polyether-ether-ketone merely For the 2%~14.5% of the artificial intervertebral disk of material, well below the wear extent of Traditional Man interverbebral disc, due to above-mentioned artificial vertebra The arc convex of disk is respectively provided with preferable anti-wear performance with arc-shaped concave, so as to effectively reduce the generation of abrasive dust, increases Life-span of artificial intervertebral disk；In addition, the first repair layer, which includes the first of stacking, repairs elementary layer and the second reparation elementary layer, the Two, which repair elementary layers, includes the 3rd of stacking and repairs elementary layer and the 4th repairing elementary layer, and first repairs the material of elementary layer and the The material of three reparation elementary layers is the mixture of sodium chloride, polyether-ether-ketone and the first degradable active bone repair material, the The material and the 4th material for repairing elementary layer of two reparation elementary layers are polyether-ether-ketone and the degradable second active Bone Defect Repari The mixture of material, and due to the first active bone repair material for containing bone-inducing factor microballoon or for by hydroxyapatite, At least one of type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and the microballoon group containing bone-inducing factor Into mixture sodium chloride composition mixture, the second active bone repair material be selected from hydroxyapatite, type alpha tricalcium phosphate, β-phosphorus At least one of sour DFP, calcium sulfate and bioactivity glass, after above-mentioned artificial intervertebral disk is implanted, these active bones are repaiied Multiple material can be degraded, so that the first repair layer and the second repair layer become a loose structure, now, area of new bone group Knitting to be grown into loose structure so that bone tissue can be combined closely one with the first repair layer and the second repair layer respectively Rise, add the first soleplate and the second soleplate in the long-time stability implanted, that is, ensure that artificial intervertebral disk in implantation people Long-time stability after body, therefore, have the longer life-span after above-mentioned artificial intervertebral disk implantation human body.

Brief description of the drawings

Fig. 1 is the structural representation of the artificial intervertebral disk of an embodiment；

Fig. 2 is the flow of the preparation method of the artificial intervertebral disk of an embodiment.

Embodiment

Make further details of theory to artificial intervertebral disk and preparation method thereof mainly in combination with drawings and the specific embodiments below It is bright.

As shown in figure 1, the artificial intervertebral disk 100 of an embodiment, including the first soleplate 110 and the second soleplate 120.Its In, the second soleplate 120 is arranged on the first soleplate 110, and the first soleplate 110 and the second soleplate 120 relative can be slided.

First soleplate 110 includes the first wearing layer 112 and the first repair layer 114 of stacking.

Wherein, side of first wearing layer 112 away from the first repair layer 114 is formed with arc convex 1122.

Wherein, the material of the first wearing layer 112 is polyether-ether-ketone and the mixture of reinforcing fiber.Mixed in polyether-ether-ketone Reinforcing fiber so that the first wearing layer 112 has preferable crocking resistance.

Wherein, the polyether-ether-ketone in the material of the first wearing layer 112 is implantation level.

It is preferred that, the particle diameter of polyether-ether-ketone is less than 40 microns.The polyether-ether-ketone of small particle is easy to mix with reinforcing fiber It is even, and defect is advantageously reduced, so as to strengthen the mechanical property of the first wearing layer 112.

Polyether-ether-ketone is a kind of height containing the repeat unit being made up of a ketonic bond and two ehter bonds in backbone structure Polymers, belongs to speciality polymer material, it has the physical and chemical performances such as high temperature resistant, chemical resistance corrosion, self lubricity, is one Class crystalline polymers material.The modulus of elasticity of polyether-ether-ketone and the modulus of elasticity of bone are sufficiently close to, and polyether-ether-ketone can be quickly Ground and bone fusion, with good biocompatibility, can be placed in organism for a long time.In addition, polyether-ether-ketone can X-ray thoroughly, in core During magnetic resonance examination, even spinal fusion part also can clearly tell the institutional framework of surrounding.

Wherein, reinforcing fiber is selected from carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-based At least one of whisker fibre.Above-mentioned reinforcing fiber is conducive to strengthening the anti-wear performance of the first wearing layer 112.

It is preferred that, a diameter of 1 nanometer~50 microns of reinforcing fiber, length is 10 microns~1000 microns.The size Reinforcing fiber can not only be well mixed with polyether-ether-ketone, continuity so as to the stress that improves the first wearing layer 112 and Even property, additionally it is possible to play the enhanced effect of nanometer, so as to improve the anti-wear performance of the first wearing layer 112.

It is preferred that, the first wearing layer 112 includes multiple the first wear-resistant elements layers 1124 stacked gradually, and multiple first is wear-resisting The material of elementary layer 1124 is polyether-ether-ketone and the mixture of reinforcing fiber.Side from the first wearing layer 112 to opposite side, The weight/mass percentage composition of reinforcing fiber in the material of multiple first wear-resistant elements layers 1124 is gradually decreased.By the first wearing layer 112 are set to multiple first wear-resistant elements layer 1124 that multiple weight/mass percentage compositions containing reinforcing fiber are gradually decreased, and make first One gradient-structure of formation of wearing layer 112.Although reinforcing fiber plays a part of one and improves anti-fatigue performance, anti-wear performance, But it is uneven to be mixed with the microstructure of the material of reinforcing fiber, and the inhomogeneities of this structure easily produces microcosmic answer Power and Strain Distribution are uneven, may cause material in maximum or intensity is minimum or most weak region is destroyed.Therefore, will It is the influence in order to gradually reduce reinforcing fiber to the first wearing layer 112 that first wearing layer 112, which is set to said structure,.

It is preferred that, in the material of each first wear-resistant elements layer 1124, the mass ratio of reinforcing fiber and polyether-ether-ketone is 0.001~0.5:1.The reinforcing fiber and polyether-ether-ketone of the proportion disclosure satisfy that the antifatigue of the first wear-resistant elements layer 1124 Presence with the requirement of anti-wear performance, and the reinforcing fiber of the ratio will not also destroy the first wear-resistant elements layer 1124.

Wherein, arc convex 1122 is formed at most the first wear-resistant elements layer of the weight/mass percentage composition containing reinforcing fiber On 1124.

It is furthermore preferred that in the material of most the first wear-resistant elements layer 1124 of the weight/mass percentage composition containing reinforcing fiber, increasing The mass ratio of strong fiber and polyether-ether-ketone is 0.1:1~0.5:1.

It is preferred that, the thickness of most the first wear-resistant elements layer 1124 of the weight/mass percentage composition containing reinforcing fiber is 50 microns ~100 microns.

It is preferred that, the first wear-resistant elements layer 1124 is 3~10.In the diagram of present embodiment, the first wear-resisting list First layer 1124 is 3.It is appreciated that in other embodiments, the first wear-resistant elements layer 1124 can also for 1,2 or It is greater than 10.

First repair layer 114 includes the first of stacking and repairs the reparation elementary layer 1144 of elementary layer 1142 and second.Wherein, Two reparation elementary layers 1144 are laminated on the first wearing layer 112.Specifically, the second reparation elementary layer 1144 is laminated in fibre containing enhancing On minimum the first wear-resistant elements layer 1124 of the weight/mass percentage composition of dimension.

Wherein, the first material for repairing elementary layer 1142 includes polyether-ether-ketone and the degradable first active Bone Defect Repari material Material.I.e. the first active bone repair material is mixed in polyether-ether-ketone.

It is preferred that, first repairs the quality of the polyether-ether-ketone and the first active bone repair material in the material of elementary layer 1142 Than for 0.1~1:1.

Wherein, first repair the polyether-ether-ketone in the material of elementary layer 1142 to be implanted into level.It is preferred that, the grain of polyether-ether-ketone Footpath is less than 40 microns.

Wherein, the first active bone repair material is hydroxyl for microballoon or the first active bone repair material containing inducible factor At least one of apatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and containing the micro- of inducible factor The mixture of ball.

Wherein, the microballoon containing bone-inducing factor can be the microballoon containing BMP-2 or the microballoon containing BMP-7.Wherein, BMP tables That show is bone morphogenetic protein (Bone morphogenetic protein).

It is preferred that, the material of microballoon is PLA, alginate, chitosan or collagen etc..

It is preferred that, the particle diameter of the first active bone repair material is 100 microns~1 millimeter.Due to active bone repair material most To degrade eventually so that first repairs the formation loose structure of elementary layer 1142.Particle diameter by the first active bone repair material is 100 microns~1 millimeter so that after active bone repair material degraded, first repairs the aperture of elementary layer 1142 in 100 microns~1 milli Rice, so as to while ensureing the intensity of the first reparation elementary layer 1142, be conducive to cell and tissue to grow into.

Second repairs mixing of the material of elementary layer 1144 for polyether-ether-ketone and the second degradable active bone repair material Thing.

Wherein, second repair the polyether-ether-ketone in the material of elementary layer 1144 to be implanted into level.And the particle diameter of polyether-ether-ketone is Less than 40 microns.

Wherein, the second active bone repair material be selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and At least one of bioactivity glass.

It is preferred that, the particle diameter of the second active bone repair material is 100 microns~1 millimeter.

After the implantation human body of artificial intervertebral disk 100, the first degradable active bone in the first reparation elementary layer 1142 is repaiied The second degradable active bone repair material in multiple material and the second reparation elementary layer 1144 can progressively be degraded, so that First repair layer 114 becomes a loose structure, and freshman bone tissue can be grown into the loose structure, so that bone tissue and first Repair layer 114 is closely combined together, it is ensured that after artificial intervertebral disk 100 implants, and the first soleplate 110 has steady in a long-term Property.

It is preferred that, second repairs elementary layer 1144 to be multiple, and multiple second reparations elementary layers 1144 are stacked gradually in the On one wearing layer 112, from the side of the first repair layer 114 to opposite side, multiple second repair in the material of elementary layer 1144 The weight/mass percentage composition of second active bone repair material is gradually decreased.Set multiple second to repair elementary layers 1144, and make its Two active bone repair materials are gradually decreased, and are in order that structure makes area of new bone constantly grow into, full of drop in a transition stage In the hole left after solution, because the second active bone repair material is can be degraded to absorb by tissue, in degradation process gradually Tissue generates the position of the second active bone repair material before new Bone Ingrowth is absorbed, and now, non-degradable component still rises To the effect of a mechanical support, without causing in degradation process because degradable component and the layering of non-degradable component are substantially broken The structure of bad artificial intervertebral disk.

Specifically, the second minimum reparation elementary layer 1144 of the weight/mass percentage composition containing the second active bone repair material is laminated In on the first wearing layer 112.More specifically, the second reparation of weight/mass percentage composition at least containing the second active bone repair material is single First layer 1144 is laminated on minimum the first wear-resistant elements layer 1124 of the weight/mass percentage composition containing reinforcing fiber.

It is preferred that, each second repairs in the material of elementary layer 1144, the second active bone repair material and polyether-ether-ketone Mass ratio is more than or equal to 0.005:1 and less than 1:1.The proportion can be after the degraded of the second active bone repair material be ensured On the premise of with certain hole, uniform stressed is remained to.

It is furthermore preferred that first repairs the matter of the polyether-ether-ketone and the first active bone repair material in the material of elementary layer 1142 Mass ratio of the amount than being more than the second active bone repair material and polyether-ether-ketone in the second material for repairing elementary layer 1144.

It is furthermore preferred that second repairs elementary layer 1144 for 2~4.In the diagram of present embodiment, second repairs single First layer 1144 is 2.It is appreciated that in other embodiments, second repairs elementary layer 1144 can also be either big for 1 In 5.

In the present embodiment, side of the first reparation elementary layer 1142 away from the second reparation elementary layer 1144 is formed with solid Fixed projection 1146, the fixed lobe 1146 can strengthen stabilization of first soleplate 110 in human body equivalent to the effect of nail Property.

Second soleplate 120 includes the second wearing layer 122 and the second repair layer 124 of stacking.

Side of second wearing layer 122 away from the second repair layer 124 is formed with arc-shaped concave 1222, arc convex 1122 with Arc-shaped concave 1222 slides against, so as to realize the relative slip between the first soleplate 110 and the second soleplate 120.Specifically, arc The curvature of shape concave surface 1222 is equal with the curvature of arc convex 1122, thus be conducive to the first soleplate 110 and the second soleplate 120 it Between relative slip.

Wherein, the material of the second wearing layer 122 is polyether-ether-ketone and the mixture of reinforcing fiber.Mixed in polyether-ether-ketone Reinforcing fiber so that the second wearing layer 122 has preferable crocking resistance.

Wherein, the polyether-ether-ketone in the material of the second wearing layer 122 is implantation level.It is micro- that the particle diameter of polyether-ether-ketone is less than 40 Rice.The polyether-ether-ketone of small particle is easy to be well mixed with reinforcing fiber, and advantageously reduces defect, so that it is wear-resisting to strengthen first The mechanical property of layer 112.

It is preferred that, reinforcing fiber is selected from carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium At least one of base whisker fibre.

It is preferred that, a diameter of 1 nanometer~50 microns of reinforcing fiber, length is 10 microns~1000 microns.The size Reinforcing fiber can not only be well mixed with polyether-ether-ketone, continuity so as to the stress that improves the second wearing layer 122 and Even property, additionally it is possible to play the enhanced effect of nanometer, so as to improve the anti-wear performance of the second wearing layer 122.

It is preferred that, the second wearing layer 122 includes multiple the second wear-resistant elements layers 1224 stacked gradually, and multiple second is wear-resisting The material of elementary layer 1224 is polyether-ether-ketone and the mixture of reinforcing fiber.Side from the second wearing layer 122 to opposite side, The weight/mass percentage composition of reinforcing fiber in the material of multiple second wear-resistant elements layers 1224 is gradually decreased.By the second wearing layer 122 are set to multiple second wear-resistant elements layer 1224 that multiple weight/mass percentage compositions containing reinforcing fiber are gradually decreased, and make second One gradient-structure of formation of wearing layer 122.Although reinforcing fiber plays a part of one and improves anti-fatigue performance, anti-wear performance, But it is uneven to be mixed with the microstructure of the material of reinforcing fiber, and the inhomogeneities of this structure easily produces microcosmic answer Power and Strain Distribution are uneven, may cause material in maximum or intensity is minimum or most weak region is destroyed.Therefore, will It is the influence in order to gradually reduce reinforcing fiber to the second wearing layer 122 that second wearing layer 122, which is set to said structure,.

It is preferred that, in the material of each second wear-resistant elements layer 1224, the mass ratio of reinforcing fiber and polyether-ether-ketone is 0.001~0.5:1.The reinforcing fiber and polyether-ether-ketone of the proportion disclosure satisfy that the antifatigue of the second wear-resistant elements layer 1224 Presence with the requirement of anti-wear performance, and the reinforcing fiber of the ratio will not also destroy the second wear-resistant elements layer 1224.

Wherein, arc-shaped concave 1222 is formed at most the second wear-resistant elements layer of the weight/mass percentage composition containing reinforcing fiber On 1224.It is preferred that, in the material of most the second wear-resistant elements layer 1224 of the weight/mass percentage composition containing reinforcing fiber, enhancing The mass ratio of fiber and polyether-ether-ketone is 0.1:1~0.5:1.

It is preferred that, the thickness of most the second wear-resistant elements layer 1224 of the weight/mass percentage composition containing reinforcing fiber is 50 microns ~100 microns.

It is furthermore preferred that the second wear-resistant elements layer 1224 is 3~10.In the diagram of present embodiment, second is wear-resisting Elementary layer 1224 is 3.It is appreciated that in other embodiments, the second wear-resistant elements layer 1224 can also for 1,2 or Person is greater than 10.

Wherein, the second repair layer 124 includes the 3rd reparation reparation elementary layer 1244 of elementary layer 1242 and the 4th of stacking.The Four reparation elementary layers 1244 are laminated on the second wearing layer 122.Specifically, the 4th reparation elementary layer 1244 is laminated in fibre containing enhancing On minimum the second wear-resistant elements layer 1224 of the weight/mass percentage composition of dimension.

3rd material for repairing elementary layer 1242 includes the mixed of polyether-ether-ketone and the first degradable active bone repair material Compound.I.e. the first active bone repair material is mixed in polyether-ether-ketone.

It is preferred that, the 3rd repairs the quality of the polyether-ether-ketone and the first active bone repair material in the material of elementary layer 1242 Than for 0.1~1:1.

Wherein, the 3rd repair the polyether-ether-ketone in the material of elementary layer 1242 to be implanted into level.It is preferred that, the grain of polyether-ether-ketone Footpath is less than 40 microns.

Wherein, the 3rd the first active bone repair material for repairing in the material of elementary layer 1242 is the microballoon containing inducible factor Or first active bone repair material be hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass At least one of and microballoon containing inducible factor mixture.

Wherein, the microballoon containing bone-inducing factor can be the microballoon containing BMP-2 or the microballoon containing BMP-7.Wherein, BMP tables That show is bone morphogenetic protein (Bone morphogenetic protein).It is preferred that, the material of microballoon is PLA, sea Alginates, chitosan or collagen etc..

It is preferred that, the 3rd particle diameter for repairing the first active bone repair material in the material of elementary layer 1242 is 100 microns ~1 millimeter.

4th repairs mixing of the material of elementary layer 1144 for polyether-ether-ketone and the second degradable active bone repair material Thing.

Wherein, the 4th repair the polyether-ether-ketone in the material of elementary layer 1144 to be implanted into level.And the particle diameter of polyether-ether-ketone is Less than 40 microns.

Wherein, the 4th the second active bone repair material repaired in the material of elementary layer 1144 is selected from hydroxyapatite, α-phosphorus At least one of sour DFP, bata-tricalcium phosphate, calcium sulfate and bioactivity glass.

After artificial intervertebral disk 100 is being implanted into human body, the 3rd repairs the first degradable active bone in elementary layer 1242 The second degradable active bone repair material in repair materials and the 4th reparation elementary layer 1244 can progressively be degraded, so that The second repair layer 124 is set to become a loose structure, freshman bone tissue can be grown into the loose structure, so that bone tissue and Two repair layers 124 are closely combined together, and are further ensured that after the implantation human body of artificial intervertebral disk 100, the second soleplate 120 has Long-time stability.

It is preferred that, the 4th repairs elementary layer 1244 to be multiple, and multiple four reparations elementary layers 1244 are stacked gradually in the On two wearing layers 122.From the side of the second repair layer 124 to opposite side, multiple four repair in the material of elementary layer 1244 The weight/mass percentage composition of second active bone repair material is gradually decreased.Set multiple four to repair elementary layers 1244, and make its Two active bone repair materials are gradually decreased, and are in order that structure makes area of new bone constantly grow into, full of drop in a transition stage In the hole left after solution, because the second active bone repair material is can be degraded to absorb by tissue, in degradation process gradually Tissue generates the position of the second active bone repair material before new Bone Ingrowth is absorbed, now, it is impossible to which the component of degraded is still So play a part of a mechanical support, without causing in degradation process because degradable component and the layering of non-degradable component are obvious And destroy the structure of artificial intervertebral disk.

Specifically, the 4th minimum reparation elementary layer 1244 of the weight/mass percentage composition containing the second active bone repair material is laminated In on the second wearing layer 122.

More specifically, the 4th 1244 layers of the elementary layer of reparation of weight/mass percentage composition at least containing the second active bone repair material It is laminated on minimum the second wear-resistant elements layer 1224 of the weight/mass percentage composition containing reinforcing fiber.

It is preferred that, in each 4th material for repairing elementary layer 1244, the second active bone repair material and polyether-ether-ketone Mass ratio be more than or equal to 0.005:1 and less than 1:1.The proportion can ensure the degraded of the second active bone repair material On the premise of there is certain hole afterwards, uniform stressed is remained to.

It is preferred that, the 3rd repairs the quality of the polyether-ether-ketone and the first active bone repair material in the material of elementary layer 1242 Than the second active bone repair material and the mass ratio of polyether-ether-ketone in the material more than the 4th reparation elementary layer 1244.

It is furthermore preferred that the 4th repairs elementary layer 1244 for 2~4.In the diagram of present embodiment, the 4th repairs single First layer 1244 is 2.It is appreciated that in other embodiments, the 4th repairs elementary layer 1244 can also be either big for 1 In 5.

In the present embodiment, connection bump 1246, and connection bump 1246 are formed with the 3rd reparation elementary layer 1242 Elementary layer 1242 is repaired away from the 4th side for repairing elementary layer 1244 positioned at the 3rd, and the connection bump 1246 is equivalent to nail Effect, can strengthen stability of second soleplate 120 in human body.

After above-mentioned artificial intervertebral disk 100 is implanted into human body, pass through the soleplate of arc convex 1122 and second of the first soleplate 110 120 arc-shaped concave 1222 slides against, to realize the relative slip of the first soleplate 110 and the second soleplate 120, and above-mentioned artificial First soleplate 110 of interverbebral disc 100 includes the first wearing layer 112 and the first repair layer 114, and it is resistance to that the second soleplate 120 includes second The repair layer 124 of layer 122 and second is ground, and the material of the material of the first wearing layer 112 and the second wearing layer 122 is polyether-ether-ketone With reinforcing fiber mixture, and arc convex 1122 be located at the first wearing layer 112 on, arc-shaped concave 1222 be located at the second wearing layer On 122 so that arc convex 1122 and arc-shaped concave 1222 are respectively provided with preferable anti-wear performance, abrasion loss amount is about 0.05~ 0.4mg/MC (MC represents million circulations), i.e. wear rate are simple using the 2% of the artificial intervertebral disk that polyether-ether-ketone is material ~14.5%, well below the wear rate of Traditional Man interverbebral disc, due to above-mentioned artificial intervertebral disk 100 arc convex 1122 with Arc-shaped concave 1222 is respectively provided with preferable anti-wear performance, so as to effectively reduce the generation of abrasive dust, adds above-mentioned artificial vertebra The life-span of disk 100；In addition, the first repair layer 114, which includes the first of stacking, repairs the reparation elementary layer of elementary layer 1142 and second 1144, second, which repairs elementary layer, includes the 3rd reparation reparation elementary layer 1244 of elementary layer 1242 and the 4th of stacking, and first repairs The material that elementary layer 1142 and the 3rd repairs elementary layer 1242 includes polyether-ether-ketone and the first degradable active bone repair material, It is that polyether-ether-ketone and the second degradable active bone are repaiied that second reparation elementary layer 1144 and the 4th, which repairs the material of elementary layer 1244, The mixture of multiple material, and because the first active bone repair material is the microballoon containing bone-inducing factor or the first active Bone Defect Repari Material is by least one of hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and contained The mixture of the mixture sodium chloride composition of the microballoon composition of bone-inducing factor, the second active bone repair material is selected from hydroxy-apatite At least one of stone, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass, when above-mentioned artificial intervertebral disk 100 After being implanted, these active bone repair materials can be degraded, so that the first repair layer 114 and the second repair layer 124 become Into a porous structure, now, freshman bone tissue can be grown into loose structure so that bone tissue can be repaiied with first respectively The repair layer 124 of cladding 114 and second is closely combined together, and adds the first soleplate 110 and the second soleplate 120 in implant Interior long-time stability, that is, ensure that long-time stability of the artificial intervertebral disk 100 after implantation human body, therefore, above-mentioned artificial vertebra There is the longer life-span after the implantation human body of disk 100.

As shown in Fig. 2 the preparation method of the artificial intervertebral disk of an embodiment, above-mentioned artificial intervertebral disk can use the reality The preparation method for applying the artificial intervertebral disk of mode is prepared, and the preparation method of the artificial intervertebral disk comprises the following steps：

Step S310：Reinforcing fiber is mixed with polyether-ether-ketone, the first mixed material is obtained.

In step S310, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

Wherein, reinforcing fiber is selected from carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-based At least one of whisker fibre.

It is preferred that, a diameter of 1 nanometer~50 microns of reinforcing fiber, length is 10 microns~1000 microns.

It is preferred that, in step S310, the step of reinforcing fiber is mixed with polyether-ether-ketone is specially：By reinforcing fiber with gathering Ether ether ketone is mixed according to multiple different mass ratioes respectively, obtains multiple first mixed materials.

In the particular embodiment, reinforcing fiber is mixed according to 3~10 different mass ratioes respectively from polyether-ether-ketone Close, obtain 3~10 the first mixed materials.

It is preferred that, the mass ratio of reinforcing fiber and polyether-ether-ketone in each first mixed material is 0.001~0.5:1.

It is furthermore preferred that in the first most mixed material of the weight/mass percentage composition containing reinforcing fiber, reinforcing fiber is with gathering The mass ratio of ether ether ketone is 0.1:1~0.5:1.

Step S320：First additive is mixed with polyether-ether-ketone, the first mixing material is obtained.Wherein, the first additive It is by hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass for sodium chloride or the first additive The mixture of at least one of glass and sodium chloride.

Wherein, in step S320, hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass It is degradable active bone repair material.And hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and biology are living The particle diameter of property glass is 100 microns~1 millimeter.

In step S320, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

Step S330：Degradable active bone repair material is mixed with polyether-ether-ketone, the second mixing material is obtained.

In step S330, active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate At least one of and bioactivity glass.

It is preferred that, the particle diameter of active bone repair material is 100 microns~1 millimeter.

In step S330, polyether-ether-ketone is implantation level.And the particle diameter of polyether-ether-ketone is less than 40 microns.

It is preferred that, in step S330, the step of degradable active bone repair material is mixed with polyether-ether-ketone is specially： Active bone repair material is mixed according to multiple different mass ratioes respectively from polyether-ether-ketone, multiple second mixing materials are obtained.

In the particular embodiment, by active bone repair material from polyether-ether-ketone respectively according to 2~4 different quality Than mixing, 2~4 the second mixing materials are obtained.

It is preferred that, the mass ratio of active bone repair material and polyether-ether-ketone in each second mixing material is more than or equal to 0.005:1 and less than 1:1.

Step S340：The first mould is provided, the first mould has the lower arcuate surface of evagination, by the first mixed material, second Mixing material and the first mixing material are sequentially added in the first mould, after shaping, remove the first mould, sintered, are obtained successively The first of stacking repairs elementary layer carcass, the second reparation elementary layer and the first wearing layer, and the first wearing layer is repaired away from second The side of elementary layer is formed with arc convex.

When the first mixed material and the second mixing material are multiple, in step S340, by the first mixed material, second The step that mixing material and the first mixing material are sequentially added in the first mould is specially：First according to the quality percentage of reinforcing fiber Multiple first mixed materials, are added in the first mould, are then repaiied according still further to active bone by the order that content is gradually decreased successively Multiple second mixing materials, are added in the first mould, connect by the weight/mass percentage composition of multiple material gradually increased order successively The first mixing material of addition.Wherein, the first most mixed material of the weight/mass percentage composition containing reinforcing fiber is added to first The bottom of mould.

Specifically, the forming method used in step S340 is cold moudling；Wherein, forming step is specially：In cold conditions Under, will add have the first mould pressurizing of the first mixed material, the first mixing material and the second mixing material to 110MPa~ 250MPa, pressurize 10 minutes~20 minutes.

Specifically, the sintering step in step S340 is specially：To remove after the first mould obtained the first sample blanks prior to 355 DEG C~400 DEG C heat preservation sinterings 20 minutes~30 minutes, then then at 220 DEG C~280 DEG C heat preservation sinterings 1 hour~2 hours. By the first sample blanks first in 355 DEG C~400 DEG C heat preservation sinterings, then again in 220 DEG C~280 DEG C heat preservation sinterings, be in order to avoid burn The Growing Process of Crystal Particles in later stage is tied, by the way that sintering temperature first to be risen to higher temperature, in molten condition, bubble is removed, makes The relative density of sample blanks reaches 70% or so；Then, sintering temperature is dropped to insulation longer time at relatively low temperature makes burning Knot proceeds, and realizes complete densification.This stage crystal grain does not substantially grow.Two-step sintering method is by cleverly The change of temperature is controlled, while crystal boundary migration (this will cause crystal grain to be grown up) is suppressed, keeping grain boundary decision, (this is that base substrate is caused The power of densification) active state is in, to realize the purpose that sintering is completed on the premise of crystal grain is not grown up.

Step S350：Cleaning remove first repair elementary layer carcass surface on sodium chloride, then will contain self-bone grafting because The microballoon of son is adsorbed on the first reparation elementary layer carcass repairs elementary layer to form first, obtains the first soleplate.

Wherein, in step S350, the microballoon containing bone-inducing factor is also degradable active bone repair material.Wherein, contain The microballoon of bone-inducing factor can be the microballoon containing BMP-2 or the microballoon containing BMP-7.Wherein, what BMP was represented is Bones morphology Albumen (Bone morphogenetic protein).

Specifically, the particle diameter of the sodium chloride used in step S320, which is more than or equal in step S350, contains bone-inducing factor Microballoon particle diameter.Wherein, the particle diameter of the microballoon containing bone-inducing factor is 100 microns~1 millimeter.

Wherein, cleaning the step of removing the sodium chloride on the first surface for repairing elementary layer carcass is specially：It is clear using water The first repair layer is washed, the sodium chloride on surface to remove the first reparation elementary layer carcass, now, first repairs elementary layer carcass Surface formed loose structure.

Wherein, the microballoon containing bone-inducing factor is adsorbed on the first reparation elementary layer carcass and repairs unit to form first In the step of layer, the microballoon containing bone-inducing factor is adsorbed on the first reparation elementary layer carcass and uses static adsorptive method.

It is preferred that, the mass ratio of active bone repair material and polyether-ether-ketone in the first reparation elementary layer is 0.1~1:1.

It is furthermore preferred that the mass ratio of the polyether-ether-ketone and active bone repair material in the first reparation elementary layer is repaiied more than second The mass ratio of active bone repair material and polyether-ether-ketone in multiple elementary layer.

Step S360：Reinforcing fiber is mixed with polyether-ether-ketone, the second mixed material is obtained.

In step S360, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

Wherein, reinforcing fiber is selected from carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-based At least one of whisker fibre.It is preferred that, a diameter of 1 nanometer~50 microns of reinforcing fiber, length is 10 microns~1000 Micron.

It is preferred that, in step S360, the step of reinforcing fiber is mixed with polyether-ether-ketone is specially：By reinforcing fiber with gathering Ether ether ketone is mixed according to multiple different mass ratioes respectively, obtains multiple second mixed materials.

In the particular embodiment, reinforcing fiber is mixed according to 3~10 different mass ratioes respectively from polyether-ether-ketone Close, obtain 3~10 the second mixed materials.

It is preferred that, the mass ratio of reinforcing fiber and polyether-ether-ketone in each second mixed material is 0.001~0.5:1.

It is furthermore preferred that reinforcing fiber and polyethers in the second most mixed material of the weight/mass percentage composition containing reinforcing fiber The mass ratio of ether ketone is 0.1:1~0.5:1.

Step S370：Second addition is mixed with polyether-ether-ketone, the 3rd mixing material is obtained.Second addition is chlorination Sodium or Second addition are in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass The mixture that at least one and sodium chloride is constituted.

Wherein, in step S370, hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass Particle diameter be 100 microns~1 millimeter.

In step S370, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

Step S380：Degradable active bone repair material is mixed with polyether-ether-ketone, the 4th mixing material is obtained.

In step S380, active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate At least one of and bioactivity glass.

In step S380, polyether-ether-ketone is implantation level.And the particle diameter of polyether-ether-ketone is less than 40 microns.

It is preferred that, in step S380, the step of degradable active bone repair material is mixed with polyether-ether-ketone is specially： Active bone repair material is mixed according to multiple different mass ratioes respectively from polyether-ether-ketone, multiple 4th mixing materials are obtained. In the particular embodiment, active bone repair material is mixed according to 2~4 different mass ratioes respectively from polyether-ether-ketone, Obtain 2~4 the second mixing materials.

It is preferred that, the mass ratio of active bone repair material and polyether-ether-ketone in each 4th mixing material is more than or equal to 0.005:1 and less than 1:1.

Step S390：The second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material, the 4th Mixing material and the 3rd mixing material are sequentially added in the second mould, after shaping, remove the second mould, sintered, are obtained successively The 3rd of stacking repairs elementary layer carcass, the 4th reparation elementary layer and the second wearing layer, and the second wearing layer is repaired away from the 4th The side of elementary layer is formed with arc-shaped concave.And arc convex is slidably abutted with arc-shaped concave.

When the second mixed material and the 4th mixing material are multiple, in step S390, by the second mixed material, the 4th The step that mixing material and the 3rd mixing material are sequentially added in the second mould is specially：First according to the quality percentage of reinforcing fiber Multiple second mixed materials, are added in the second mould, are then repaiied according still further to active bone by the order that content is gradually decreased successively Multiple 4th mixing materials, are added in the second mould, connect by the weight/mass percentage composition of multiple material gradually increased order successively The 3rd mixing material of addition.Wherein, the second most mixed material of the weight/mass percentage composition containing reinforcing fiber is added to second The bottom of mould.

Specifically, the forming method used in step S390 is cold moudling；Wherein, forming step is specially：In cold conditions Under, will add have the second mould pressurizing of the second mixed material, the 4th mixing material and the 3rd mixing material to 110MPa~ 250MPa, pressurize 10 minutes~20 minutes.

Specifically, the sintering step in step S390 is specially：To remove after the second mould obtained the second sample blanks prior to 355 DEG C~400 DEG C heat preservation sinterings 20 minutes~30 minutes, then then at 220 DEG C~280 DEG C heat preservation sinterings 1 hour~2 hours. By the second sample blanks first in 355 DEG C~400 DEG C heat preservation sinterings, then again in 220 DEG C~280 DEG C heat preservation sinterings, be in order to avoid burn The Growing Process of Crystal Particles in later stage is tied, by the way that sintering temperature first to be risen to higher temperature, in molten condition, bubble is removed, makes The relative density of sample blanks reaches 70% or so；Then, sintering temperature is dropped to insulation longer time at relatively low temperature makes burning Knot proceeds, and realizes complete densification.This stage crystal grain does not substantially grow.Two-step sintering method is by cleverly The change of temperature is controlled, while crystal boundary migration (this will cause crystal grain to be grown up) is suppressed, keeping grain boundary decision, (this is that base substrate is caused The power of densification) active state is in, to realize the purpose that sintering is completed on the premise of crystal grain is not grown up.

Step S400：Cleaning remove the 3rd repair elementary layer carcass surface on sodium chloride, then will contain self-bone grafting because The microballoon of son is adsorbed on the 3rd reparation elementary layer carcass and repairs elementary layer to form the 3rd, obtains the second soleplate.

Wherein, in step S400, the microballoon containing bone-inducing factor can be the microballoon containing BMP-2 or the microballoon containing BMP-7. Wherein, that BMP is represented is bone morphogenetic protein (Bone morphogenetic protein).

Specifically, the particle diameter of the sodium chloride used in step S370, which is more than or equal in step S400, contains bone-inducing factor Microballoon particle diameter.Wherein, the particle diameter of the microballoon containing bone-inducing factor is 100 microns~1 millimeter.

Wherein, cleaning the step of removing the sodium chloride on the 3rd surface for repairing elementary layer carcass is specially：It is clear using water The second repair layer is washed, the sodium chloride on surface to remove the 3rd reparation elementary layer carcass, now, the 3rd repairs elementary layer carcass Surface formed loose structure.

Wherein, the microballoon containing bone-inducing factor is adsorbed on the 3rd reparation elementary layer carcass and repairs unit to form the 3rd In the step of layer, the microballoon containing bone-inducing factor is adsorbed on the 3rd reparation elementary layer carcass and uses static adsorptive method.

It is preferred that, the 3rd repairs in elementary layer, and the mass ratio of active bone repair material and polyether-ether-ketone is 0.1~1:1.

It is furthermore preferred that the 3rd repairs polyether-ether-ketone in elementary layer and the mass ratio of the first active bone repair material is more than the Two repair the mass ratio of the active bone repair material and polyether-ether-ketone in elementary layer.

After step S350 and step S400, in addition to the first soleplate and the second soleplate are cleaned respectively, dried, The step of packaging and sterilizing.

It is appreciated that in specific operating process, being not limited only to prepare using said sequence, it can also use other Sequentially, for example, step S310 and step S320 can be with reversed orders；Or, step S360~S400 can be first carried out, then carry out Step S310~S350 etc..

The preparation method of above-mentioned artificial intervertebral disk is simple, it is adaptable to industrialized production.

It is embodiment part below：

Embodiment 1

The artificial intervertebral disk of the present embodiment prepares as follows：

(1) it is 0.1 according to mass ratio:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, the first mixture is obtained Material, wherein, reinforcing fiber is glass fibre, a diameter of 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(2) the first additive is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the first addition Agent is two kinds of type alpha tricalcium phosphate and sodium chloride, and the particle diameter of type alpha tricalcium phosphate is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(3) it is 0.3 according to mass ratio:1, active bone repair material and polyether-ether-ketone are mixed, the second mixing material is obtained, Wherein, active bone repair material is type alpha tricalcium phosphate, and particle diameter is 100 microns, and particle diameter is 30 microns.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, by the first mixed material, the second mixing material Material and the first mixing material are added sequentially in the first mould, wherein, the first mixed material is added to the bottom of the first mould, so Cold moudling is carried out to the first mould pressurizing to 110MP afterwards, pressurize 20 minutes removes the first mould, then prior to 355 DEG C insulations Sintering 30 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, first be laminated repaired elementary layer carcass, second repairs elementary layer With the first wearing layer, wherein, the thickness of the first wearing layer is 50 microns, and the first wearing layer is away from the second side for repairing elementary layer It is formed with arc convex.

(5) cleaned to remove the sodium chloride on the first reparation elementary layer carcass surface, will be contained using static adsorptive method with water BMP-2 microballoon is adsorbed in the first reparation elementary layer carcass, so that obtain first repairs the type alpha tricalcium phosphate in elementary layer It is 0.5 with the gross mass of BMP-2 microballoon and the mass ratio of polyether-ether-ketone:1, that is, the first soleplate is obtained, wherein, the material of microballoon Matter is PLA, and particle diameter is 100 microns.

(6) it is 0.1 according to mass ratio:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, the second mixture is obtained Material, wherein, reinforcing fiber is glass fibre, a diameter of 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(7) Second addition is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the second addition Agent is two kinds of type alpha tricalcium phosphate and sodium chloride, and the particle diameter of type alpha tricalcium phosphate is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(8) it is 0.3 according to mass ratio:1, active bone repair material and polyether-ether-ketone are mixed, the 4th mixing material is obtained, Wherein, active bone repair material is type alpha tricalcium phosphate, and particle diameter is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of evagination, by the second mixed material, the 4th mixing material Material and the 3rd mixing material are added sequentially in the second mould, wherein, the second mixed material is added to the bottom of the second mould, so Cold moudling is carried out to the second mould pressurizing to 110MP afterwards, pressurize 20 minutes removes the second mould, then prior to 355 DEG C insulations Sintering 30 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, the 3rd be laminated repaired elementary layer carcass, the 4th repairs elementary layer With the second wearing layer, wherein, the thickness of the second wearing layer is 50 microns, and the second wearing layer repairs the one of elementary layer away from the 4th Side is formed with arc-shaped concave.

(10) cleaned to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, will be contained using static adsorptive method with water BMP-2 microballoon is adsorbed in the 3rd reparation elementary layer carcass, so that the obtain the 3rd repairs the type alpha tricalcium phosphate in elementary layer It is 0.5 with the gross mass of BMP-2 microballoon and the mass ratio of polyether-ether-ketone：1, that is, the second soleplate is obtained, wherein, the material of microballoon Expect for PLA, particle diameter is 100 microns.

So as to obtain the artificial intervertebral disk of the present embodiment.Then local repair is carried out to the first soleplate and the second soleplate respectively Reason, cleaning, drying, packaging and sterilizing.

According to ISO18192-1 or ASTM F2423 method to the arc convex of the first soleplate and the arc of the second soleplate The frictional behaviour test that concave surface is carried out, the arc-shaped concave of the arc convex of first soleplate of the present embodiment and the second soleplate is passed through After the friction of million times, the wear extent for obtaining the artificial intervertebral disk of the present embodiment is shown in Table 1.

Modulus of elasticity test, the elasticity of the present embodiment are carried out to the artificial intervertebral disk of the present embodiment according to ISO527 method Modulus is shown in Table 1.

Embodiment 2

(1) respectively according to mass ratio be 0.1:1、0.08:1 and 0.06:1, by the polyether-ether-ketone of reinforcing fiber and implantation level Mixing, obtains the first mixed material 1, the first mixed material 2 and the first mixed material 3, wherein, reinforcing fiber is carbon fiber, stone Five kinds of black fiber, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber, a diameter of 1 nanometer of reinforcing fiber, length is 10 Micron, the particle diameter of polyether-ether-ketone is 20 microns.

(2) the first additive is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the first addition Agent be hydroxyapatite, bata-tricalcium phosphate, calcium sulfate, bioactivity glass and sodium chloride, hydroxyapatite, bata-tricalcium phosphate, The particle diameter of calcium sulfate and bioactivity glass is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(3) it is 0.2 according to mass ratio:1 and 0.3:1, active bone repair material and polyether-ether-ketone are mixed, second is obtained and mixes The mixing material 2 of condensation material 1 and second, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate and calcium sulfate three Kind, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, by the first mixed material 1, the first mixture The 2, first mixed material 3 of material, the second mixing material 1, the second mixing material 2 and the first mixing material are added in the first mould, Wherein, the first mixed material 1 is added to the bottom of the first mould, then carries out cold moudling to the first mould pressurizing to 200MP, Pressurize 15 minutes, removes the first mould, then prior to 400 DEG C heat preservation sinterings 20 minutes, then at 280 DEG C of heat preservation sinterings 1 hour, obtains Elementary layer carcass, the second reparation elementary layer and the first wearing layer are repaired to first stacked gradually, wherein, the first wearing layer is remote The side of second reparation elementary layer is formed with arc convex, and the first wearing layer has three the first wear-resistant elements stacked gradually Layer, and the thickness of the remote second the first wear-resistant elements layer for repairing elementary layer is 100 microns, second repairs elementary layer for two.

(5) cleaned with water to remove the sodium chloride on the first reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed in the first reparation elementary layer carcass for 200 microns of the microballoon containing BMP-7, so that obtain first repairs elementary layer In hydroxyapatite, bata-tricalcium phosphate, calcium sulfate, the gross mass and polyethers ether of bioactivity glass and the microballoon containing BMP-7 The mass ratio of ketone is 0.4:1, that is, the first soleplate is obtained, wherein, the material of microballoon is alginate.

(6) respectively according to mass ratio be 0.1:1、0.08:1 and 0.06:1, by the polyether-ether-ketone of reinforcing fiber and implantation level Mixing, obtains the second mixed material 1, the second mixed material 2 and the second mixed material 3, wherein, reinforcing fiber is carbon fiber, stone Five kinds of black fiber, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber, a diameter of 1 nanometer of reinforcing fiber, length is 10 Micron, the particle diameter of polyether-ether-ketone is 20 microns.

(7) Second addition is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the second addition Agent is five kinds of hydroxyapatite, bata-tricalcium phosphate, calcium sulfate, bioactivity glass and sodium chloride, hydroxyapatite, β-tricresyl phosphate The particle diameter of calcium, calcium sulfate and bioactivity glass is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(8) it is 0.2 according to mass ratio:1 and 0.3:1, active bone repair material and polyether-ether-ketone are mixed, the 4th is obtained and mixes The mixing material 2 of condensation material 1 and the 4th, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and life Four kinds of thing activity glass, particle diameter is 200 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material 1, the second mixture The 2, second mixed material 3 of material, the 4th mixing material 1, the 4th mixing material 2 and the 3rd mixing material are added sequentially to the second mould In, wherein, the second mixed material 1 is added to the bottom of the second mould, and then the second mould pressurizing to 200MP is cold-pressed into Type, pressurize 15 minutes removes the second mould, and then prior to 400 DEG C heat preservation sinterings 20 minutes, small then at 280 DEG C of heat preservation sinterings 1 When, the 3rd stacked gradually repairs elementary layer carcass, the 4th reparation elementary layer and the second wearing layer, wherein, second is wear-resisting Side of the layer away from the 4th reparation elementary layer is formed with arc-shaped concave, the second wearing layer have three stack gradually it is second wear-resisting Elementary layer, the thickness away from the 4th the second wear-resistant elements layer for repairing elementary layer is 100 microns, and the 4th reparation elementary layer is two It is individual.

(10) cleaned with water to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, using static adsorptive method particle diameter It is adsorbed to for 200 microns of the microballoons containing BMP-7 in the 3rd reparation elementary layer carcass, so that the obtain the 3rd repairs in elementary layer Hydroxyapatite, bata-tricalcium phosphate, calcium sulfate, the gross mass and polyether-ether-ketone of bioactivity glass and the microballoon containing BMP-7 Mass ratio be 0.4:1, that is, the second soleplate is obtained, wherein, the material of microballoon is alginate.

Embodiment 3

(1) respectively according to mass ratio be 0.1:1、0.095:1、0.090:1、0.080:1、0.075:1、0.070:1、 0.065:1、0.060:1、0.055:1 and 0.050:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, first is obtained and mixes Compound material 1, the first mixed material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6th, the first mixed material 7, the first mixed material 8, the first mixed material 9 and the first mixed material 10, wherein, reinforcing fiber is stone Black two kinds of fiber and silicon carbide fibre, a diameter of 1 nanometer of reinforcing fiber, length is 1000 microns, and the particle diameter of polyether-ether-ketone is 25 microns.

(2) the first additive is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the first addition Agent is four kinds of hydroxyapatite, calcium sulfate, bioactivity glass and sodium chloride, hydroxyapatite, calcium sulfate and bioactivity glass The particle diameter of glass is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(3) it is 0.1 according to mass ratio:1、0.2:1、0.3:1 and 0.4:1, active bone repair material is mixed with polyether-ether-ketone Close, respectively obtain the second mixing material 1, the second mixing material 2, the second mixing material 3 and the second mixing material 4, active bone is repaiied Multiple material is three kinds of hydroxyapatite, calcium sulfate and bioactivity glass, and particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is micro- for 25 Rice.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, successively mixes the first mixed material 1, first Compound material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6, the first mixed material 7th, the first mixed material 8, the first mixed material 9, the first mixed material 10, the second mixing material 1, the second mixing material 2, second Mixing material 3, the second mixing material 4 and the first mixing material are added sequentially in the first mould, wherein, the first mixed material 1 The bottom of the first mould is added to, cold moudling is then carried out to the first mould pressurizing to 250MP, pressurize 10 minutes removes the One mould, then prior to 380 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, first be laminated was repaired Elementary layer carcass, second repair elementary layer and the first wearing layer, wherein, side of first wearing layer away from the second repair layer carcass Arc convex is formed with, the first wearing layer has ten the first wear-resistant elements stacked gradually layers, wherein, repair single away from second The thickness of the first wear-resistant elements layer of first layer is 100 microns, and second repairs elementary layer for four.

(5) cleaned with water to remove the sodium chloride on the first reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed on the first reparation elementary layer carcass for 1 millimeter of the microballoon containing BMP-7, so that obtain first repairs in elementary layer Hydroxyapatite, calcium sulfate, bioactivity glass and the gross mass of the microballoon containing BMP-7 and the mass ratio of polyether-ether-ketone be 0.5:1, that is, the first soleplate is obtained, the material of microballoon is chitosan.

(6) respectively according to mass ratio be 0.1:1、0.095:1、0.090:1、0.080:1、0.075:1、0.070:1、 0.065:1、0.060:1、0.055:1 and 0.050:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, second is obtained and mixes Compound material 1, the second mixed material 2, the second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6th, the second mixed material 7, the second mixed material 8, the second mixed material 9 and the second mixed material 10, wherein, reinforcing fiber is stone Black two kinds of fiber and silicon carbide fibre, a diameter of 1 nanometer of reinforcing fiber, length is 1000 microns, and the particle diameter of polyether-ether-ketone is 25 microns.

(7) Second addition is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the second addition Agent is hydroxyapatite, calcium sulfate, bioactivity glass and sodium chloride, hydroxyapatite, calcium sulfate and bioactivity glass Particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(8) it is 0.1 according to mass ratio:1、0.2:1、0.3:1 and 0.4:1, active bone repair material is mixed with polyether-ether-ketone Close, respectively obtain the 4th mixing material 1, the 4th mixing material 2, the 4th mixing material 3 and the 4th mixing material 4, active bone is repaiied Multiple material is three kinds of hydroxyapatite, calcium sulfate and bioactivity glass, and particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is micro- for 25 Rice.

(9) the second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material 1, the second mixture Expect the 2, second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the second mixed material 7, the Two mixed materials 8, the second mixed material 9, the second mixed material 10, the 4th mixing material 1, the mixing of the 4th mixing material the 2, the 4th Material 3, the 4th mixing material 4 and the 3rd mixing material are added sequentially in the second mould, wherein, the second mixed material 1 is added To the bottom of the first mould, cold moudling is then carried out to the first mould pressurizing to 250MP, pressurize 10 minutes removes the second mould Tool, then prior to 380 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd reparation elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, side of second wearing layer away from the second repair layer carcass is formed with arc Concave surface, the second wearing layer has ten the second wear-resistant elements stacked gradually layers, wherein, repair the second of elementary layer away from the 4th The thickness of wear-resistant elements layer is 100 microns, and the 4th repairs elementary layer for four.

(10) cleaned with water to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed in the 3rd reparation elementary layer carcass for 1 millimeter of the microballoon containing BMP-7, so that the obtain the 3rd repairs in elementary layer Hydroxyapatite, calcium sulfate, bioactivity glass and the gross mass of the microballoon containing BMP-7 and the mass ratio of polyether-ether-ketone be 0.5:1, that is, the second soleplate is obtained, the material of microballoon is chitosan.

Embodiment 4

(1) respectively according to mass ratio be 0.5:1、0.4:1、0.3:1、0.2:1、0.1:1 and 0.05:1, by reinforcing fiber with The polyether-ether-ketone mixing of level is implanted into, the first mixed material 1, the first mixed material 2, the first mixed material 3, the first mixture is obtained Expect the 4, first mixed material 5 and the first mixed material 6, wherein, reinforcing fiber is silicon carbide fibre, a diameter of 50 microns, length For 500 microns, the particle diameter of polyether-ether-ketone is 10 microns.

(2) the first additive is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the first addition Agent is three kinds of hydroxyapatite, bioactivity glass and sodium chloride, and the particle diameter of hydroxyapatite and bioactivity glass is 200 Micron, the particle diameter of polyether-ether-ketone is 10 microns.

(3) it is 0.2 according to mass ratio:1、0.3:1 and 0.4:1, active bone repair material is mixed with polyether-ether-ketone, respectively The second mixing material 1, the second mixing material 2 and the second mixing material 3 are obtained, wherein, active bone repair material is hydroxy-apatite Stone and bioactivity glass, particle diameter are 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, successively mixes the first mixed material 1, first Compound material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6, the second mixing material 1st, the second mixing material 2, the second mixing material 3 and the first mixing material are added sequentially in the first mould, wherein, the first mixing Material 1 is added to the bottom of the first mould, then carries out cold moudling to the first mould pressurizing to 200MP, and pressurize 15 minutes is gone Except the first mould, then prior to 355 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, first be laminated Elementary layer carcass, the second reparation elementary layer and the first wearing layer are repaired, wherein, the first wearing layer is away from the second repair layer carcass Side is formed with arc convex, and the first wearing layer has six the first wear-resistant elements stacked gradually layers, wherein, repaiied away from second The thickness of the first wear-resistant elements layer of multiple elementary layer is 50 microns, and second repairs elementary layer for three.

(5) cleaned with water to remove the sodium chloride on the first reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed on the first reparation elementary layer carcass for 200 microns of the microballoon containing BMP-2, so that obtain first repairs elementary layer In hydroxyapatite, the mass ratio of the gross mass of bioactivity glass and the microballoon containing BMP-2 and polyether-ether-ketone be 0.5: 1, that is, the first soleplate is obtained, wherein, the material of microballoon is chitosan.

(6) respectively according to mass ratio be 0.5:1、0.4:1、0.3:1、0.2:1、0.1:1 and 0.05:1, by reinforcing fiber with The polyether-ether-ketone mixing of level is implanted into, the second mixed material 1, the second mixed material 2, the second mixed material 3, the second mixture is obtained Expect the 4, second mixed material 5 and the second mixed material 6, wherein, reinforcing fiber is silicon carbide fibre, a diameter of 50 microns, length For 500 microns, the particle diameter of polyether-ether-ketone is 10 microns.

(7) Second addition is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the second addition Agent is three kinds of hydroxyapatite, bioactivity glass and sodium chloride, and the particle diameter of hydroxyapatite and bioactivity glass is 200 Micron, the particle diameter of polyether-ether-ketone is 10 microns.

(8) it is 0.2 according to mass ratio:1、0.3:1 and 0.4:1, active bone repair material is mixed with polyether-ether-ketone, respectively The 4th mixing material 1, the 4th mixing material 2 and the 4th mixing material 3 are obtained, wherein, active bone repair material is hydroxy-apatite Stone and bioactivity glass, particle diameter are 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material 1, the second mixture Expect the 2, second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the 4th mixing material 1, the Four mixing materials 2, the 4th mixing material 3 and the 3rd mixing material are added sequentially in the second mould, wherein, the second mixed material 1 is added to the bottom of the first mould, and cold moudling is then carried out to the first mould pressurizing to 200MP, and pressurize 15 minutes removes the Two molds, then prior to 355 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd reparation elementary layer Carcass, the 4th repair elementary layer and the second wearing layer, wherein, side of second wearing layer away from the 4th repair layer carcass is formed with Arc-shaped concave, the second wearing layer has six the second wear-resistant elements stacked gradually layers, wherein, repair elementary layer away from the 4th The thickness of second wear-resistant elements layer is 50 microns, and the 4th repairs elementary layer for three.

(10) cleaned with water to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed in the 3rd reparation elementary layer carcass for 200 microns containing BMP-2, so that obtain first repairs the hydroxyl in elementary layer The mass ratio of base apatite, the gross mass of bioactivity glass and the microballoon containing BMP-2 and polyether-ether-ketone is 0.5:1, produce To the second soleplate, wherein, the material of microballoon is chitosan.

Embodiment 5

(1) it is 0.1 according to mass ratio:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixed material, Wherein, reinforcing fiber is glass fibre, a diameter of 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(2) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the grain of polyether-ether-ketone Footpath is 30 microns.

(3) it is 0.2 according to mass ratio:1, active bone repair material and polyether-ether-ketone are mixed, the second mixing material is obtained, Wherein, active bone repair material is type alpha tricalcium phosphate, and particle diameter is 100 microns, and particle diameter is 30 microns.

(5) cleaned to remove the sodium chloride on the first reparation elementary layer carcass surface, will be contained using static adsorptive method with water BMP-2 microballoon is adsorbed in the first reparation elementary layer carcass so that obtain first repair elementary layer in containing the micro- of BMP-2 The mass ratio of ball and polyether-ether-ketone is 0.4:1, that is, the first soleplate is obtained, wherein, the material of microballoon is PLA, and particle diameter is 100 Micron.

(6) respectively according to mass ratio be 0.1:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, second is obtained and mixes Compound material, wherein, reinforcing fiber is glass fibre, a diameter of 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 Micron.

(7) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the grain of polyether-ether-ketone Footpath is 30 microns.

(8) it is 0.2 according to mass ratio:1, active bone repair material and polyether-ether-ketone are mixed, the 4th mixing material is obtained, Wherein, active bone repair material is type alpha tricalcium phosphate, and particle diameter is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of evagination, by the second mixed material, the 4th mixing material Material and the 3rd mixing material are added sequentially in the second mould, wherein, the second mixed material is added to the bottom of the second mould, so Cold moudling is carried out to the second mould pressurizing to 110MP afterwards, pressurize 20 minutes removes the second mould, then prior to 355 DEG C insulations Sintering 30 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, the 3rd be laminated repaired elementary layer carcass, the 4th repairs elementary layer With the second wearing layer, wherein, the thickness of the second wearing layer is 50 microns, and the second wear-resistant elements layer repairs elementary layer away from the 4th Side be formed with arc-shaped concave.

(10) cleaned to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, will be contained using static adsorptive method with water BMP-2 microballoon be adsorbed to the 3rd reparation elementary layer carcass in so that obtain the 3rd repair elementary layer in containing the micro- of BMP-2 The mass ratio of ball and polyether-ether-ketone is 0.4:1, that is, the second soleplate is obtained, wherein, the material of microballoon is PLA, and particle diameter is 100 Micron.

Embodiment 6

(2) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the grain of polyether-ether-ketone Footpath is 20 microns.

(3) it is 0.8 according to mass ratio:1 and 0.9:1, active bone repair material and polyether-ether-ketone are mixed, second is obtained and mixes The mixing material 2 of condensation material 1 and second, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and life Four kinds of thing activity glass, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, by the first mixed material 1, the first mixture The 2, first mixed material 3 of material, the second mixing material 1, the second mixing material 2 and the first mixing material are added in the first mould, Wherein, the first mixed material 1 is added to the bottom of the first mould, then carries out cold moudling to the first mould pressurizing to 200MP, Pressurize 15 minutes, removes the first mould, then prior to 400 DEG C heat preservation sinterings 20 minutes, then at 280 DEG C of heat preservation sinterings 1 hour, obtains Elementary layer carcass, the second reparation elementary layer and the first wearing layer are repaired to first stacked gradually, wherein, the first wear-resistant elements layer Side away from the second reparation elementary layer is formed with arc convex, and the first wearing layer has three the first wear-resisting lists stacked gradually First layer, and the thickness away from the second the first wear-resistant elements layer for repairing elementary layer is 100 microns, the second reparation elementary layer is two It is individual.

(5) cleaned with water to remove the sodium chloride on the first reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed in the first reparation elementary layer carcass for 200 microns of the microballoon containing BMP-7, so that obtain first repairs elementary layer In microballoon containing BMP-7 and the mass ratio of polyether-ether-ketone be 1：1, that is, the first soleplate is obtained, wherein, the material of microballoon is marine alga Hydrochlorate.

(7) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the grain of polyether-ether-ketone Footpath is 20 microns.

(8) it is 0.8 according to mass ratio:1 and 0.9:1, active bone repair material and polyether-ether-ketone are mixed, the 4th is obtained and mixes The mixing material 2 of condensation material 1 and the 4th, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and life Four kinds of thing activity glass, particle diameter is 200 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material 1, the second mixture The 2, second mixed material 3 of material, the 4th mixing material 1, the 4th mixing material 2 and the 3rd mixing material are added sequentially to the second mould In, wherein, the second mixed material 1 is added to the bottom of the second mould, and then the second mould pressurizing to 200MP is cold-pressed into Type, pressurize 15 minutes removes the second mould, and then prior to 400 DEG C heat preservation sinterings 20 minutes, small then at 280 DEG C of heat preservation sinterings 1 When, the 3rd stacked gradually repairs elementary layer carcass, the 4th reparation elementary layer and the second wearing layer, wherein, second is wear-resisting Side of the elementary layer away from the 4th reparation elementary layer is formed with arc-shaped concave, the second wearing layer have three stack gradually second Wear-resistant elements layer, and the thickness away from the 4th the second wear-resistant elements layer for repairing elementary layer is 100 microns, the 4th repairs elementary layer For two.

(10) cleaned with water to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, using static adsorptive method particle diameter It is adsorbed to for 200 microns of the microballoons containing BMP-7 in the 3rd reparation elementary layer carcass, so that the obtain the 3rd repairs in elementary layer Microballoon containing BMP-7 and the mass ratio of polyether-ether-ketone be 1:1, that is, the second soleplate is obtained, wherein, the material of microballoon is alginic acid Salt.

Embodiment 7

(1) respectively according to mass ratio be 0.1:1、0.095:1、0.090:1、0.080:1、0.075:1、0.070:1、 0.065:1、0.060:1、0.055:1 and 0.050:1, reinforcing fiber is mixed with being implanted into the polyether-ether-ketone of level, first is obtained and mixes Compound material 1, the first mixed material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6th, the first mixed material 7, the first mixed material 8, the first mixed material 9 and the first mixed material 10, wherein, reinforcing fiber is stone Black fiber and silicon carbide fibre, a diameter of 1 nanometer of reinforcing fiber, length is 1000 microns, and the particle diameter of polyether-ether-ketone is micro- for 25 Rice.

(2) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the grain of polyether-ether-ketone Footpath is 25 microns.

(3) it is 0.05 according to mass ratio:1、0.10:1、0.15:1 and 0.20:1, by active bone repair material and polyethers ether Ketone is mixed, and respectively obtains the second mixing material 1, the second mixing material 2, the second mixing material 3 and the second mixing material 4, activity Bone renovating material is three kinds of hydroxyapatite, calcium sulfate and bioactivity glass, and particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, successively mixes the first mixed material 1, first Compound material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6, the first mixed material 7th, the first mixed material 8, the first mixed material 9, the first mixed material 10, the second mixing material 1, the second mixing material 2, second Mixing material 3, the second mixing material 4 and the first mixing material are added sequentially in the first mould, wherein, the first mixed material 1 The bottom of the first mould is added to, cold moudling is then carried out to the first mould pressurizing to 250MP, pressurize 10 minutes removes the One mould, then prior to 380 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, first be laminated was repaired Elementary layer carcass, second repair elementary layer and the first wearing layer, wherein, side of first wearing layer away from the first repair layer carcass Arc convex is formed with, the first wearing layer has ten the first wear-resistant elements stacked gradually layers, wherein, repair single away from second The thickness of the first wear-resistant elements layer of first layer is 50 microns, and second repairs elementary layer for four.

(5) cleaned with water to remove the sodium chloride on the first reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed on the first reparation elementary layer carcass for 1 millimeter of the microballoon containing BMP-7, so that obtain first repairs in elementary layer Microballoon containing BMP-7 and the mass ratio of polyether-ether-ketone be 0.25:1, that is, the first soleplate is obtained, the material of microballoon is chitosan.

(7) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the grain of polyether-ether-ketone Footpath is 25 microns.

(8) it is 0.05 according to mass ratio:1、0.10:1、0.15:1 and 0.20:1, by active bone repair material and polyethers ether Ketone is mixed, and respectively obtains the 4th mixing material 1, the 4th mixing material 2, the 4th mixing material 3 and the 4th mixing material 4, activity Bone renovating material is three kinds of hydroxyapatite, calcium sulfate and bioactivity glass, and particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material 1, the second mixture Expect the 2, second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the second mixed material 7, the Two mixed materials 8, the second mixed material 9, the second mixed material 10, the 4th mixing material 1, the mixing of the 4th mixing material the 2, the 4th Material 3, the 4th mixing material 4 and the 3rd mixing material are added sequentially in the second mould, wherein, the second mixed material 1 is added To the bottom of the first mould, cold moudling is then carried out to the first mould pressurizing to 250MP, pressurize 10 minutes removes the second mould Tool, then prior to 355 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd reparation elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, side of second wearing layer away from the first repair layer carcass is formed with arc Concave surface, the second wearing layer has ten the second wear-resistant elements stacked gradually layers, wherein, repair the second of elementary layer away from the 4th The thickness of wear-resistant elements layer is 50 microns, and the 4th repairs elementary layer for four.

(10) cleaned with water to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed in the 3rd reparation elementary layer carcass for 1 millimeter of the microballoon containing BMP-7, so that the obtain the 3rd repairs in elementary layer Microballoon containing BMP-7 and the mass ratio of polyether-ether-ketone be 0.25:1, that is, the second soleplate is obtained, the material of microballoon is chitosan.

Embodiment 8

(1) respectively according to mass ratio be 0.5:1、0.45:1、0.40:1、0.35:1、0.30.1:1 and 0.25:1, it will strengthen Fiber is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixed material 1, the first mixed material 2, the first mixed material 3, first Mixed material 4, the first mixed material 5 and the first mixed material 6, wherein, reinforcing fiber is silicon carbide fibre, and a diameter of 50 is micro- Rice, length is 500 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(2) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the first mixing material, wherein, the grain of polyether-ether-ketone Footpath is 10 microns.

(3) it is 0.04 according to mass ratio:1、0.06:1 and 0.08:1, active bone repair material is mixed with polyether-ether-ketone, The second mixing material 1, the second mixing material 2 and the second mixing material 3 are respectively obtained, wherein, active bone repair material is hydroxyl Apatite and bioactivity glass, particle diameter are 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(4) the first mould is provided, the first mould has the lower arcuate surface of evagination, successively mixes the first mixed material 1, first Compound material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6, the second mixing material 1st, the second mixing material 2, the second mixing material 3 and the first mixing material are added sequentially in the first mould, wherein, the first mixing Material 1 is added to the bottom of the first mould, then carries out cold moudling to the first mould pressurizing to 200MP, and pressurize 15 minutes is gone Except the first mould, then prior to 355 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, first be laminated Elementary layer carcass, the second reparation elementary layer and the first wearing layer are repaired, wherein, the first wearing layer is away from the first repair layer carcass Side is formed with arc convex, and the first wearing layer has six the first wear-resistant elements stacked gradually layers, wherein, repaiied away from second The thickness of the first wear-resistant elements layer of multiple elementary layer is 100 microns, and second repairs elementary layer for three.

(5) cleaned with water to remove the sodium chloride on the first reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed on the first reparation elementary layer carcass for 200 microns of the microballoon containing BMP-2, so that obtain first repairs elementary layer In microballoon containing BMP-2 and the mass ratio of polyether-ether-ketone be 0.1:1, that is, the first soleplate is obtained, wherein, the material of microballoon is shell Glycan.

(6) respectively according to mass ratio be 0.5:1、0.45:1、0.40:1、0.35:1、0.30.1:1 and 0.25:1, it will strengthen Fiber is mixed with being implanted into the polyether-ether-ketone of level, obtains the second mixed material 1, the second mixed material 2, the second mixed material 3, second Mixed material 4, the second mixed material 5 and the second mixed material 6, wherein, reinforcing fiber is silicon carbide fibre, and a diameter of 50 is micro- Rice, length is 500 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(7) sodium chloride is mixed with being implanted into the polyether-ether-ketone of level, obtains the 3rd mixing material, wherein, the grain of polyether-ether-ketone Footpath is 10 microns.

(8) it is 0.04 according to mass ratio:1、0.06:1 and 0.08:1, active bone repair material is mixed with polyether-ether-ketone, The 4th mixing material 1, the 4th mixing material 2 and the 4th mixing material 3 are respectively obtained, wherein, active bone repair material is hydroxyl Apatite and bioactivity glass, particle diameter are 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(9) the second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material 1, the second mixture Expect the 2, second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the 4th mixing material 1, the Four mixing materials 2, the 4th mixing material 3 and the 3rd mixing material are added sequentially in the second mould, wherein, the second mixed material 1 is added to the bottom of the first mould, and cold moudling is then carried out to the first mould pressurizing to 200MP, and pressurize 15 minutes removes the Two molds, then prior to 355 DEG C heat preservation sinterings 25 minutes, then at 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd reparation elementary layer Carcass, the 4th repair elementary layer and the second wearing layer, wherein, side of second wearing layer away from the first repair layer carcass is formed with Arc-shaped concave, the second wearing layer has six the second wear-resistant elements stacked gradually layers, wherein, repair elementary layer away from the 4th The thickness of second wear-resistant elements layer is 100 microns, and the 4th repairs elementary layer for three.

(10) cleaned with water to remove the sodium chloride on the 3rd reparation elementary layer carcass surface, using static adsorptive method by grain Footpath is adsorbed in the 3rd reparation elementary layer carcass for 200 microns containing BMP-2, so that containing in the 3rd obtained reparation elementary layer BMP-2 microballoon and the mass ratio of polyether-ether-ketone are 0.1:1, that is, the second soleplate is obtained, wherein, the material of microballoon is chitosan.

Table 1 represent be after the friction of million times, the artificial intervertebral disk of 1~embodiment of embodiment 8 and comparative example 1 Wear extent and modulus of elasticity.Wherein, comparative example 1 is traditional only with the artificial intervertebral disk that polyether-ether-ketone is material.

Table 1

	Wear extent	Modulus of elasticity
			Embodiment 1	0.05mg/MC	22.32GPa
Embodiment 2	0.12mg/MC	20.87GPa
			Embodiment 3	0.07mg/MC	21.62GPa
Embodiment 4	0.40mg/MC	19.42GPa
			Embodiment 5	0.05mg/MC	22.42GPa
Embodiment 6	0.11mg/MC	20.95GPa
			Embodiment 7	0.07mg/MC	21.34GPa
Embodiment 8	0.36mg/MC	19.86GPa
			Comparative example 1	2.5mg/MC	(3.86±0.72)GPa

As it can be seen from table 1 the wear extent of the artificial intervertebral disk of 1~embodiment of embodiment 8 is up to 0.4mg/MC, at least Only 0.05mg/MC, and the wear extent of traditional artificial intervertebral disk of comparative example 1 is 2.5mg/MC, i.e. embodiment 1~8 people The wear extent of work interverbebral disc is only the 2.0%~14.5% of the wear extent of the artificial intervertebral disk of comparative example 1, embodiment 1~implementation The wear extent of the artificial intervertebral disk of example 8 is far below the wear extent of the artificial intervertebral disk of comparative example 1, i.e. 1~embodiment of embodiment 8 Artificial intervertebral disk has preferable anti-wear performance.

Can also be learnt from table 1, the modulus of elasticity of the artificial intervertebral disk of 1~embodiment of embodiment 8 for (21.10 ± 1.07) GPa, and the modulus of elasticity of people's bone be 17~20GPa, the modulus of elasticity of the artificial intervertebral disk of 1~embodiment of embodiment 8 with People's bone is sufficiently close to, i.e., have good biocompatibility with people's bone.And documents 1 is traditional only with polyether-ether-ketone The modulus of elasticity of artificial intervertebral disk is (3.86 ± 0.72) Gpa, it is clear that differ larger with the modulus of elasticity of people's bone, bio-compatible Property does not have the artificial intervertebral disk of 1~embodiment of embodiment 8 good.

Embodiment described above only expresses the several embodiments of the present invention, and it describes more specific and detailed, but simultaneously Therefore the limitation to the scope of the claims of the present invention can not be interpreted as.It should be pointed out that for one of ordinary skill in the art For, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to the guarantor of the present invention Protect scope.Therefore, the protection domain of patent of the present invention should be determined by the appended claims.

Claims

1. a kind of artificial intervertebral disk, it is characterised in that including：

First soleplate, includes the first wearing layer and the first repair layer of stacking, and first wearing layer is repaired away from described first The side of layer is formed with arc convex, and first repair layer includes the first of stacking and repairs elementary layer and the second reparation unit Layer, the second reparation elementary layer is laminated on first wearing layer；And

Second soleplate, is arranged on first soleplate, and second soleplate and first soleplate relative can be slided, and described the Two soleplates include the second wearing layer and the second repair layer of stacking, side of second wearing layer away from second repair layer Arc-shaped concave is formed with, and the arc convex slides against with the arc-shaped concave, second repair layer includes stacking 3rd repairs elementary layer and the 4th reparation elementary layer, and the 4th reparation elementary layer is laminated on second wearing layer；

Wherein, the material of the material of first wearing layer and second wearing layer is the mixed of polyether-ether-ketone and reinforcing fiber Compound, described first, which repairs the material of elementary layer and the described 3rd material for repairing elementary layer, includes polyether-ether-ketone and degradable The first active bone repair material, it is described second repair elementary layer material and it is described 4th repair elementary layer material be poly- The mixture of ether ether ketone and the second degradable active bone repair material, first active bone repair material be containing self-bone grafting because The microballoon or first active bone repair material of son are by hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate And the mixture of at least one of bioactivity glass and the microballoon composition containing bone-inducing factor, the described second active Bone Defect Repari Material is selected from least one of hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass；

First wearing layer includes multiple the first wear-resistant elements layers stacked gradually, the material of multiple first wear-resistant elements layers Material is the mixture of the polyether-ether-ketone and the reinforcing fiber, and the side from first wearing layer is described to opposite side The weight/mass percentage composition of the reinforcing fiber in the material of multiple first wear-resistant elements layers is gradually decreased, and described second repairs single Member is laminated on minimum first wear-resistant elements layer of the weight/mass percentage composition containing the reinforcing fiber layer by layer, the arc convex It is formed on most first wear-resistant elements layer of the weight/mass percentage composition containing the reinforcing fiber；

Second wearing layer includes multiple the second wear-resistant elements layers stacked gradually, the material of multiple second wear-resistant elements layers Material is the mixture of the polyether-ether-ketone and the reinforcing fiber, and the side from second wearing layer is described to opposite side The weight/mass percentage composition of the reinforcing fiber in the material of multiple second wear-resistant elements layers is gradually decreased, and the described 4th repairs single First layer second wear-resistant elements layer stackup minimum with the weight/mass percentage composition containing the reinforcing fiber, the arc-shaped concave shape On most second wear-resistant elements layer of the weight/mass percentage composition of reinforcing fiber described in Cheng Yuhan；

The diameter of reinforcing fiber in the material of first wearing layer and the second wearing layer is 1 nanometer~50 microns, and length is 10 microns~1000 microns；It is micro- that the particle diameter of the polyether-ether-ketone of the material of the material of first wearing layer and the second wearing layer is respectively less than 40 Rice.

2. artificial intervertebral disk according to claim 1, it is characterised in that the weight/mass percentage composition containing the reinforcing fiber is most In the material of many first wear-resistant elements layers, the mass ratio of the reinforcing fiber and the polyether-ether-ketone is 0.1:1~ 0.5:1；

In the material of most second wear-resistant elements layer of weight/mass percentage composition containing the reinforcing fiber, the reinforcing fiber Mass ratio with the polyether-ether-ketone is 0.1:1~0.5:1.

3. artificial intervertebral disk according to claim 1, it is characterised in that the weight/mass percentage composition containing the reinforcing fiber is most The thickness of many first wear-resistant elements layers is 50 microns~100 microns；

The thickness of most second wear-resistant elements layer of weight/mass percentage composition containing the reinforcing fiber is micro- for 50 microns~100 Rice.

4. artificial intervertebral disk according to claim 1, it is characterised in that the second reparation elementary layer is multiple and many Individual second reparation elementary layer is stacked gradually on first wearing layer, from the side of first repair layer to opposite side, institute The weight/mass percentage composition for stating second active bone repair material in the material of multiple second reparation elementary layers is gradually decreased, and is contained It is resistance to that minimum the second reparation elementary layer of the weight/mass percentage composition of second active bone repair material is laminated in described first Grind on layer；

Described 4th repairs elementary layer to be multiple, and multiple four reparations elementary layers are stacked gradually on second wearing layer, From the side of second repair layer to opposite side, the multiple 4th repairs second active bone in the material of elementary layer The weight/mass percentage composition of repair materials is gradually decreased, the minimum institute of the weight/mass percentage composition containing second active bone repair material The 4th reparation elementary layer is stated to be laminated on second wearing layer.

5. artificial intervertebral disk according to claim 1, it is characterised in that the reinforcing fiber is selected from carbon fiber, glass fibers At least one of dimension, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.

6. artificial intervertebral disk according to claim 1, it is characterised in that first active bone repair material and described The particle diameter of two active bone repair materials is 100 microns~1 millimeter.

7. a kind of preparation method of artificial intervertebral disk as claimed in claim 1, it is characterised in that comprise the following steps：

First additive is mixed with polyether-ether-ketone, the first mixing material is obtained, first additive is sodium chloride or institute State the first additive be in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass at least The mixture that a kind of and sodium chloride is constituted；

The first mould is provided, first mould has the lower arcuate surface of evagination, first mixed material, described second are mixed Condensation material and first mixing material are sequentially added in first mould, after shaping, remove first mould, through burning Knot, first stacked gradually repairs elementary layer carcass, second repairs elementary layer and the first wearing layer, and described first wear-resisting Side of the layer away from the described second reparation elementary layer is formed with arc convex；

Cleaning removes the sodium chloride on the described first surface for repairing elementary layer carcass, then by containing the micro- of bone-inducing factor Ball is adsorbed to described first and repaired on elementary layer carcass to form the first reparation elementary layer, obtains the first soleplate；

Second addition is mixed with polyether-ether-ketone, the 3rd mixing material is obtained, the Second addition is sodium chloride or institute State Second addition be in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass at least The mixture that a kind of and sodium chloride is constituted；

Degradable active bone repair material is mixed with polyether-ether-ketone, the 4th mixing material is obtained, wherein, second mixing Active bone repair material in material and the 4th mixing material is selected from hydroxyapatite, type alpha tricalcium phosphate, β-tricresyl phosphate At least one of calcium, calcium sulfate and bioactivity glass；

The second mould is provided, second mould has the lower arcuate surface of indent, second mixed material, the described 4th are mixed Condensation material and the 3rd mixing material are sequentially added in second mould, after shaping, remove second mould, through burning Knot, the 3rd stacked gradually repairs elementary layer carcass, the 4th repairs elementary layer and the second wearing layer, and described second wear-resisting Side of the layer away from the described 4th reparation elementary layer is formed with arc-shaped concave, and the arc convex can be slided with the arc-shaped concave It is dynamic to abut；And

Cleaning removes the sodium chloride on the described 3rd surface for repairing elementary layer carcass, then by containing the micro- of bone-inducing factor Ball is adsorbed on the second repair layer carcass repairs elementary layer to form the 3rd, obtains the second soleplate.