CN105310802A

CN105310802A - Artificial intervertebral disc and manufacturing method thereof

Info

Publication number: CN105310802A
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: 2016-02-10
Anticipated expiration: 2034-06-03
Also published as: CN105310802B

Abstract

An artificial intervertebral disc comprises a first end plate and a second end plate, wherein the first end plate comprises a first abrasion-resisting layer and a first repairing layer which are stacked, and the first repairing layer comprises a first repairing unit layer and a second repairing unit layer which are stacked. The second end plate comprises a second abrasion-resisting layer and a second repairing layer which are stacked, and the second repairing layer comprises a third repairing unit layer and a fourth repairing unit layer which are stacked. The first abrasion-resisting layer and the second abrasion-resisting layer are both made from a polyether-ether-ketone and reinforcing fiber mixture, the first repairing unit layer and the third repairing unit layer are both made from the mixture of polyether-ether-ketone and a first degradable active bone repairing material, and the second repairing unit layer and the fourth repairing unit layer are both made from the mixture of polyether-ether-ketone and a second degradable active bone repairing material. The artificial intervertebral disc has longer service life after being implanted into a human body. In addition, the invention further provides a manufacturing method of the artificial intervertebral disc.

Description

Artificial intervertebral disk and preparation method thereof

Technical field

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

Background technology

Cervical spondylosis and lumbar spondylosis are a kind of spine disorderses caused due to intervertebral disk retrogression pathological changes, have become the commonly encountered diseases of appreciable impact middle-aged and elderly people quality of life and high morbidity.Wherein, in lumbar spondylosis, prolapse of lumbar intervertebral disc total incidence reaches 15.2 ~ 30%, and China lumbar spondylosis patient breaks through 200,000,000 at present, and the adult of 80% had lumbago medical history.Clinical statistics shows, the age is greater than 50 years old person 40% has limitation of activity situation with upper lumbar spine, and wherein 60% can produce lumbal vertebra, disease appears in pressuring nerve system, and the patient of about 10%-15% finally can develop into spinal compression, thus may cause paraplegia.And cervical spondylosis aspect more allows of no optimist, along with aged tendency of population, bend over the desk in the face of computer increase and traffic accident take place frequently for a long time, the cervical spine injury caused increases year by year, and cervical spondylosis sickness rate rises fast.Current China sickness rate accounts for the 7%-10% of country's total population, wherein about 50 years old crowd's sickness rate has exceeded 25%, within 60 ~ 70 years old, sickness rate can up to 50%, and middle-young patients sharply increases in addition, and within less than 30 years old, adolescent patients has accounted for 11% of total number of patients.

The treatment of intervertebral disc degeneration disease has operation and No operation two kinds of methods.Non-operative treatment only can relief of symptoms, and can not effect a radical cure, the patient of significant proportion must be treated surgically.In clinical, due to the advantage such as spinal fusion instant effect, good effect, operation be simple, once becoming for many years " goldstandard " of disc disease operative treatment.But this operative therapy still exist some regret, fusion can cause the physiological activity degree of lesion segment to be lost, adjacent segment motion and load increase, Adjacent segment degeneration will be accelerated to a certain extent.Clinical research finds, post-fusion have an appointment 25.6% patient there is neighbouring section secondary affection in 10 years after surgery.Reaching in 21 years follow up a case by regular visits to, the patient of 14% need perform the operation again.For solving post-decompression shakiness, maintain disc height, and retain vertebra internode appropriateness physiological activity, inspire by hip replacement, artificial disc replacement (TDR) arises at the historic moment.Compared with anterior cervical spine fusion and lumbar vertebra posterior-path fusion art; TDR has maintenance operated level normal activity degree and stability, improvement are close to pressure in intervertebral space, reduce the advantages such as neighbouring section neopathy rate, is considered to the most promising spinal biomechanics reconstruction technique.And the artificial neck that TDR uses or lumbar intervertebral disc, then become emphasis and the focus of international research exploitation in the nature of things.

Domesticly carry out the existing nearly 20 years history of TDR operation, existing a large amount of clinical case, but regrettably used product is all import.But along with the fast development of spinal column non-fusion technology, TDR day by day popularizes and extensively approves, the sickness rate of compatriots' cervical and lumbar diseases continues soaring, and the artificial intervertebral disk product of exploitation production domesticization is imperative.And the exploitation of the artificial intervertebral disk that domesticizes mainly faces following technological challenge: after intervertebral disc implant into body, prosthese is under the complicated mechanics/physiological environment of human body, there is heavy wear in articular surface material, produce a large amount of abrasive dust, various wear particle brings out inflammatory reaction, cause Periprosthetic bone to dissolve, finally occur prosthetic loosening, cause prosthese life-span wretched insufficiency.

Summary of the invention

Given this, there is after being necessary to provide a kind of implant into body the artificial intervertebral disk of longer life.

In addition, also provide a kind of preparation method of artificial intervertebral disk, after artificial intervertebral disk implant into body prepared by the method, there is the longer life-span.

A kind of artificial intervertebral disk, comprising:

First soleplate, comprise the first stacked wearing layer and the first repair layer, described first wearing layer is formed with arc convex away from the side of described first repair layer, described first repair layer comprises stacked the first reparation elementary layer and second and repairs elementary layer, and described second repairs elementary layer is laminated on described first wearing layer; And

Second soleplate, be arranged on described first soleplate, described second soleplate and described first soleplate can relative slidings, described second soleplate comprises the second stacked wearing layer and the second repair layer, described second wearing layer is formed with arc-shaped concave away from the side of described second repair layer, and described arc convex slides with described arc-shaped concave and abuts, described second repair layer comprises the stacked 3rd and repairs elementary layer and the 4th and repair elementary layer, and the described 4th repairs elementary layer is laminated on described second wearing layer;

Wherein, the material of described first wearing layer and the material of described second wearing layer are the mixture of polyether-ether-ketone and fortifying fibre, the material of the described first material and described 3rd reparation elementary layer repairing elementary layer includes polyether-ether-ketone and degradable first active bone repair material, the material of the described second material and described 4th reparation elementary layer repairing elementary layer is the mixture of polyether-ether-ketone and degradable second active bone repair material, described first active bone repair material is for by hydroxyapatite containing the microsphere of bone-inducing factor or described first active bone repair material, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass and the mixture of mixture sodium chloride composition formed containing the microsphere of bone-inducing factor, described second active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass.

Wherein in an embodiment, described first wearing layer comprises multiple the first wear-resistant elements layer stacked gradually, the material of multiple described first wear-resistant elements layer is the mixture of described polyether-ether-ketone and described fortifying fibre, from the side of described first wearing layer to opposite side, the mass percentage of the described fortifying fibre in the material of described multiple first wear-resistant elements layer reduces gradually, described second repairs elementary layer is laminated in containing on the minimum described first wear-resistant elements layer of the mass percentage of described fortifying fibre, described arc convex is formed at containing on the maximum described first wear-resistant elements layer of the mass percentage of described fortifying fibre,

Described second wearing layer comprises multiple the second wear-resistant elements layer stacked gradually, the material of multiple described second wear-resistant elements layer is the mixture of described polyether-ether-ketone and described fortifying fibre, from the side of described second wearing layer to opposite side, the mass percentage of the described fortifying fibre in the material of described multiple second wear-resistant elements layer reduces gradually, described 4th repairs elementary layer is laminated in containing on the minimum described second wear-resistant elements layer of the mass percentage of described fortifying fibre, described arc-shaped concave is formed at containing on the maximum described second wear-resistant elements layer of the mass percentage of described fortifying fibre.

Wherein in an embodiment, in the material containing the maximum described first wear-resistant elements layer of the mass percentage of described fortifying fibre, the mass ratio of described fortifying fibre and described polyether-ether-ketone is 0.1:1 ~ 0.5:1;

In material containing the maximum described second wear-resistant elements layer of the mass percentage of described fortifying fibre, the mass ratio of described fortifying fibre and described polyether-ether-ketone is 0.1:1 ~ 0.5:1.

Wherein in an embodiment, the thickness of the described first wear-resistant elements layer that the mass percentage containing described fortifying fibre is maximum is 50 microns ~ 100 microns;

Thickness containing the maximum described second wear-resistant elements layer of the mass percentage of described fortifying fibre is 50 microns ~ 100 microns.

Wherein in an embodiment, described second reparation elementary layer is multiple, and multiple second reparation elementary layer stacks gradually on described first wearing layer, from the side of described first repair layer to opposite side, described multiple second mass percentage of described second active bone repair material repaired in the material of elementary layer reduces gradually, minimum described second the repairing elementary layer and be laminated on described first wearing layer of the mass percentage containing described second active bone repair material;

Described 4th reparation elementary layer is multiple, and multiple 4th reparation elementary layer stacks gradually on described second wearing layer, from the side of described second repair layer to opposite side, described multiple 4th mass percentage of described second active bone repair material repaired in the material of elementary layer reduces gradually, minimum the described 4th the repairing elementary layer and be laminated on described second wearing layer of the mass percentage containing described second active bone repair material.

Wherein in an embodiment, described fortifying fibre is selected from least one in carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.

Wherein in an embodiment, the diameter of described fortifying fibre is 1 nanometer ~ 50 micron, and length is 10 microns ~ 1000 microns.

Wherein in an embodiment, the particle diameter of described polyether-ether-ketone is less than 40 microns.

Wherein in an embodiment, the particle diameter of described first active bone repair material and described second active bone repair material is 100 microns ~ 1 millimeter.

A preparation method for artificial intervertebral disk, comprises the steps:

Fortifying fibre is mixed with polyether-ether-ketone, obtains the first mixed material;

First additive is mixed with polyether-ether-ketone, obtain the first composite material, described first additive is sodium chloride or described first additive is the mixture be made up of at least one in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and sodium chloride;

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

First mould is provided, described first mould has the lower arcuate surface of evagination, described first mixed material, described second composite material and described first composite material are added in described first mould successively, after molding, remove described first mould, through sintering, obtain stacking gradually first repairs elementary layer carcass, second repairs elementary layer and the first wearing layer, and described first wearing layer is formed with arc convex away from the side that described second repairs elementary layer;

Cleaning is removed described first and is repaired described sodium chloride on the surface of elementary layer carcass, then the microsphere containing bone-inducing factor is adsorbed to described first and repairs on elementary layer carcass to form the first reparation elementary layer, obtain the first soleplate;

Fortifying fibre is mixed with polyether-ether-ketone, obtains the second mixed material;

Second addition is mixed with polyether-ether-ketone, obtain the 3rd composite material, described Second addition is sodium chloride or described Second addition is the mixture be made up of at least one in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and sodium chloride;

Degradable active bone repair material is mixed with polyether-ether-ketone, obtain the 4th composite material, wherein, the active bone repair material in described second composite material and described 4th composite material is all selected from least one in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass;

Second mould is provided, described second mould has the lower arcuate surface of indent, described second mixed material, described 4th composite material and described 3rd composite material are added in described second mould successively, after molding, remove described second mould, through sintering, obtain stacking gradually the 3rd repairs elementary layer carcass, the 4th repairs elementary layer and the second wearing layer, and described second wearing layer is formed with arc-shaped concave away from the side that the described 4th repairs elementary layer, and described arc convex slidably abuts with described arc-shaped concave; And

The described sodium chloride on the surface of described 3rd reparation elementary layer carcass is removed in cleaning, is then adsorbed to by the microsphere containing bone-inducing factor on described second repair layer carcass and repairs elementary layer to form the 3rd, obtain the second soleplate.

When after above-mentioned artificial intervertebral disk implant into body, to be slided with the arc-shaped concave of the second soleplate by the arc convex of the first soleplate and abut, to realize the relative sliding of the first soleplate and the second soleplate, and the first soleplate of above-mentioned artificial intervertebral disk comprises the first stacked wearing layer and the first repair layer, and the second soleplate comprises the second stacked wearing layer and the second repair layer, and the material of the material of the first wearing layer and the second wearing layer is the mixture of polyether-ether-ketone and fortifying fibre, and arc convex is positioned on the first wearing layer, arc-shaped concave is positioned on the second wearing layer, arc convex and arc-shaped concave is made all to have good anti-wear performance, abrasion loss amount is about 0.05 ~ 0.4mg/MC (MC represents 1,000,000 circulations), namely wear rate is 2% ~ 14.5% of the artificial intervertebral disk using merely polyether-ether-ketone to be material, well below the wear extent of Traditional Man intervertebral disc, because the arc convex of above-mentioned artificial intervertebral disk and arc-shaped concave all have good anti-wear performance, thus effectively reduce the generation of abrasive dust, add the life-span of artificial intervertebral disk, in addition, first repair layer comprises stacked the first reparation elementary layer and second and repairs elementary layer, second repairs elementary layer comprises the 3rd stacked reparation elementary layer and the 4th reparation elementary layer, the material of the first material and the 3rd reparation elementary layer repairing elementary layer is sodium chloride, the mixture of polyether-ether-ketone and degradable first active bone repair material, the material of the second material and the 4th reparation elementary layer repairing elementary layer is the mixture of polyether-ether-ketone and degradable second active bone repair material, and due to the first active bone repair material be containing the microsphere of bone-inducing factor or for by hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass and the mixture of mixture sodium chloride composition formed containing the microsphere of bone-inducing factor, second active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass, after above-mentioned artificial intervertebral disk is implanted, these active bone repair materials can be degraded, thus make the first repair layer and the second repair layer all become a loose structure, now, freshman bone tissue can grow in loose structure, osseous tissue can be combined with the first repair layer and the second repair layer respectively closely, add the long-time stability that the first soleplate and the second soleplate are implanting, namely ensure that the long-time stability of artificial intervertebral disk after implant into body, therefore, after above-mentioned artificial intervertebral disk implant into body, there is the longer life-span.

Accompanying drawing explanation

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

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

Detailed description of the invention

Mainly in conjunction with the drawings and the specific embodiments artificial intervertebral disk and preparation method thereof is described in further detail below.

As shown in Figure 1, the artificial intervertebral disk 100 of an embodiment, comprises the first soleplate 110 and the second soleplate 120.Wherein, the second soleplate 120 is arranged on the first soleplate 110, and the first soleplate 110 and the second soleplate 120 can relative slidings.

First soleplate 110 comprises the first stacked wearing layer 112 and the first repair layer 114.

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

Wherein, the material of the first wearing layer 112 is the mixture of polyether-ether-ketone and fortifying fibre.In polyether-ether-ketone, mix fortifying fibre, make the first wearing layer 112 have good crocking resistance.

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

Preferably, the particle diameter of polyether-ether-ketone is less than 40 microns.The polyether-ether-ketone of small particle diameter is easy to mix homogeneously with fortifying fibre, and is conducive to reducing defect, thus strengthens the mechanical property of the first wearing layer 112.

Polyether-ether-ketone is a kind of high polymer containing the repetitive be made up of a ketonic bond and two ehter bonds in backbone structure, belong to speciality polymer material, it has high temperature resistant, the physical and chemical performance such as chemical resistance corrosion, self lubricity, is a class crystalline polymers material.The elastic modelling quantity of polyether-ether-ketone and the elastic modelling quantity of bone very close, and polyether-ether-ketone can merge with bone soon, has good biocompatibility, can be placed in organism for a long time.In addition, polyether-ether-ketone can X-ray thoroughly, when nuclear magnetic resonance check, even spinal fusion part also clearly can tell the organizational structure of surrounding.

Wherein, fortifying fibre is selected from least one in carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.Above-mentioned fortifying fibre is conducive to the anti-wear performance of enhancing first wearing layer 112.

Preferably, the diameter of fortifying fibre is 1 nanometer ~ 50 micron, and length is 10 microns ~ 1000 microns.The fortifying fibre of this size can not only with polyether-ether-ketone mix homogeneously, thus seriality and the uniformity of the stress of the first wearing layer 112 can be improved, the effect that nanometer strengthens can also be played, thus improve the anti-wear performance of the first wearing layer 112.

Preferably, the first wearing layer 112 comprises multiple the first wear-resistant elements layer 1124 stacked gradually, and the material of multiple first wear-resistant elements layer 1124 is the mixture of polyether-ether-ketone and fortifying fibre.From the side of the first wearing layer 112 to opposite side, the mass percentage of the fortifying fibre in the material of multiple first wear-resistant elements layer 1124 reduces gradually.First wearing layer 112 is set to multiple multiple first wear-resistant elements layers 1124 reduced gradually containing the mass percentage of fortifying fibre, makes the first wearing layer 112 form a gradient-structure.Although fortifying fibre plays the effect that is improved anti-fatigue performance, anti-wear performance, but the microstructure being mixed with the material of fortifying fibre is uneven, the inhomogeneities of this structure easily produces the stress and strain skewness of microcosmic, and material may be caused to destroy in maximum or that intensity is minimum or the weakest region.Therefore, the first wearing layer 112 being set to said structure is to reduce the impact of fortifying fibre on the first wearing layer 112 gradually.

Preferably, in the material of each first wear-resistant elements layer 1124, the mass ratio of fortifying fibre and polyether-ether-ketone is 0.001 ~ 0.5:1.The fortifying fibre of this proportion and polyether-ether-ketone can meet the resisting fatigue of the first wear-resistant elements layer 1124 and the requirement of anti-wear performance, and the existence of the fortifying fibre of this ratio also can not destroy the first wear-resistant elements layer 1124.

Wherein, arc convex 1122 is formed at containing on maximum the first wear-resistant elements layer 1124 of the mass percentage of fortifying fibre.

Preferred, in the material containing maximum the first wear-resistant elements layer 1124 of the mass percentage of fortifying fibre, the mass ratio of fortifying fibre and polyether-ether-ketone is 0.1:1 ~ 0.5:1.

Preferably, the thickness containing maximum the first wear-resistant elements layer 1124 of the mass percentage of fortifying fibre is 50 microns ~ 100 microns.

Preferably, the first wear-resistant elements layer 1124 is 3 ~ 10.In the diagram of present embodiment, the first wear-resistant elements layer 1124 is 3.Be appreciated that in other embodiments, the first wear-resistant elements layer 1124 also can be 1,2 or be greater than 10.

First repair layer 114 comprises the first stacked reparation elementary layer 1142 and second and repairs elementary layer 1144.Wherein, the second reparation elementary layer 1144 is laminated on the first wearing layer 112.Concrete, second repairs elementary layer 1144 is laminated in containing on minimum the first wear-resistant elements layer 1124 of the mass percentage of fortifying fibre.

Wherein, the first material repairing elementary layer 1142 comprises polyether-ether-ketone and degradable first active bone repair material.Namely the first active bone repair material is mixed in polyether-ether-ketone.

Preferably, first polyether-ether-ketone in the material of elementary layer 1142 is repaired and the mass ratio of the first active bone repair material is 0.1 ~ 1:1.

Wherein, the first polyether-ether-ketone repaired in the material of elementary layer 1142 is implantation level.Preferably, the particle diameter of polyether-ether-ketone is less than 40 microns.

Wherein, the first active bone repair material is be the mixture of at least one in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and the microsphere containing inducible factor containing the microsphere of inducible factor or the first active bone repair material.

Wherein, the microsphere containing bone-inducing factor can be the microsphere containing BMP-2 or the microsphere containing BMP-7.Wherein, that BMP represents is bone morphogenetic protein (Bonemorphogeneticprotein).

Preferably, the material of microsphere is polylactic acid, alginate, chitosan or collagen etc.

Preferably, the particle diameter of the first active bone repair material is 100 microns ~ 1 millimeter.Because active bone repair material finally will be degraded, the first reparation elementary layer 1142 is made to form loose structure.By the particle diameter of the first active bone repair material be 100 microns ~ 1 millimeter, after active bone repair material is degraded, first repairs elementary layer 1142 aperture at 100 microns ~ 1 millimeter, thus while ensureing the intensity of the first reparation elementary layer 1142, is conducive to biological cells and tissues and grows into.

Second material repairing elementary layer 1144 is the mixture of polyether-ether-ketone and degradable second active bone repair material.

Wherein, the second polyether-ether-ketone repaired in the material of elementary layer 1144 is implantation level.And the particle diameter of polyether-ether-ketone is for being less than 40 microns.

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

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

After artificial intervertebral disk 100 implant into body, degradable first active bone repair material in first reparation elementary layer 1142 and the second degradable second active bone repair material repaired in elementary layer 1144 can progressively be degraded, thus make the first repair layer 114 become a loose structure, freshman bone tissue can grow in this loose structure, combine closely to make osseous tissue and the first repair layer 114, after ensureing that artificial intervertebral disk 100 implants, the first soleplate 110 has long-time stability.

Preferably, second reparation elementary layer 1144 is multiple, and multiple second reparation elementary layer 1144 stacks gradually on the first wearing layer 112, from the side of the first repair layer 114 to opposite side, the mass percentage of the multiple second the second active bone repair material repaired in the material of elementary layer 1144 reduces gradually.Arrange multiple second and repair elementary layer 1144, and its second active bone repair material is reduced gradually, to make structure be in a transition stage, area of new bone is constantly grown into, in the hole stayed after being full of degraded, because the second active bone repair material is can by tissue degraded and absorbed, in degradation process, tissue generates new Bone Ingrowth by the position of the second active bone repair material before absorbing gradually, now, degradable component does not still play the effect of a mechanical support, and can not cause in degradation process because degradable component and the layering of non-degradable component obviously destroy the structure of artificial intervertebral disk.

Concrete, minimum second the repairing elementary layer 1144 and be laminated on the first wearing layer 112 of the mass percentage containing the second active bone repair material.More specifically, containing minimum second the repairing elementary layer 1144 and be laminated in containing on minimum the first wear-resistant elements layer 1124 of the mass percentage of fortifying fibre of the mass percentage of the second active bone repair material.

Preferably, each second repairs in the material of elementary layer 1144, and the mass ratio of the second active bone repair material and polyether-ether-ketone is more than or equal to 0.005:1 and is less than 1:1.Under this proportion can have the prerequisite in certain hole after the degraded of guarantee second active bone repair material, still can uniform stressed.

Preferred, first repairs the mass ratio that polyether-ether-ketone in the material of elementary layer 1142 and the mass ratio of the first active bone repair material be greater than the second active bone repair material in the material of the second reparation elementary layer 1144 and polyether-ether-ketone.

Preferred, the second reparation elementary layer 1144 is 2 ~ 4.In the diagram of present embodiment, the second reparation elementary layer 1144 is 2.Be appreciated that in other embodiments, second repairs elementary layer 1144 also can be 1 or be greater than 5.

In the present embodiment, first repairs elementary layer 1142 is formed with fixed lobe 1146 away from the side that second repairs elementary layer 1144, and this fixed lobe 1146 is equivalent to the effect of nail, can strengthen the stability of the first soleplate 110 in human body.

Second soleplate 120 comprises the second stacked wearing layer 122 and the second repair layer 124.

Second wearing layer 122 is formed with arc-shaped concave 1222 away from the side of the second repair layer 124, and arc convex 1122 slides with arc-shaped concave 1222 and abuts, thus realizes the relative sliding between the first soleplate 110 and the second soleplate 120.Concrete, the curvature of arc-shaped concave 1222 is equal with the curvature of arc convex 1122, thus is conducive to the relative sliding between the first soleplate 110 and the second soleplate 120.

Wherein, the material of the second wearing layer 122 is the mixture of polyether-ether-ketone and fortifying fibre.In polyether-ether-ketone, mix fortifying fibre, make the second wearing layer 122 have good crocking resistance.

Wherein, the polyether-ether-ketone in the material of the second wearing layer 122 is for implanting level.The particle diameter of polyether-ether-ketone is less than 40 microns.The polyether-ether-ketone of small particle diameter is easy to mix homogeneously with fortifying fibre, and is conducive to reducing defect, thus strengthens the mechanical property of the first wearing layer 112.

Preferably, fortifying fibre is selected from least one in carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.

Preferably, the diameter of fortifying fibre is 1 nanometer ~ 50 micron, and length is 10 microns ~ 1000 microns.The fortifying fibre of this size can not only with polyether-ether-ketone mix homogeneously, thus seriality and the uniformity of the stress of the second wearing layer 122 can be improved, the effect that nanometer strengthens can also be played, thus improve the anti-wear performance of the second wearing layer 122.

Preferably, the second wearing layer 122 comprises multiple the second wear-resistant elements layer 1224 stacked gradually, and the material of multiple second wear-resistant elements layer 1224 is the mixture of polyether-ether-ketone and fortifying fibre.From the side of the second wearing layer 122 to opposite side, the mass percentage of the fortifying fibre in the material of multiple second wear-resistant elements layer 1224 reduces gradually.Second wearing layer 122 is set to multiple multiple second wear-resistant elements layers 1224 reduced gradually containing the mass percentage of fortifying fibre, makes the second wearing layer 122 form a gradient-structure.Although fortifying fibre plays the effect that is improved anti-fatigue performance, anti-wear performance, but the microstructure being mixed with the material of fortifying fibre is uneven, the inhomogeneities of this structure easily produces the stress and strain skewness of microcosmic, and material may be caused to destroy in maximum or that intensity is minimum or the weakest region.Therefore, the second wearing layer 122 being set to said structure is to reduce the impact of fortifying fibre on the second wearing layer 122 gradually.

Preferably, in the material of each second wear-resistant elements layer 1224, the mass ratio of fortifying fibre and polyether-ether-ketone is 0.001 ~ 0.5:1.The fortifying fibre of this proportion and polyether-ether-ketone can meet the resisting fatigue of the second wear-resistant elements layer 1224 and the requirement of anti-wear performance, and the existence of the fortifying fibre of this ratio also can not destroy the second wear-resistant elements layer 1224.

Wherein, arc-shaped concave 1222 is formed at containing on maximum the second wear-resistant elements layer 1224 of the mass percentage of fortifying fibre.Preferably, in the material of the second wear-resistant elements layer 1224 maximum containing the mass percentage of fortifying fibre, the mass ratio of fortifying fibre and polyether-ether-ketone is 0.1:1 ~ 0.5:1.

Preferably, the thickness containing maximum the second wear-resistant elements layer 1224 of the mass percentage of fortifying fibre is 50 microns ~ 100 microns.

Preferred, the second wear-resistant elements layer 1224 is 3 ~ 10.In the diagram of present embodiment, the second wear-resistant elements layer 1224 is 3.Be appreciated that in other embodiments, the second wear-resistant elements layer 1224 also can be 1,2 or be greater than 10.

Wherein, the second repair layer 124 comprises the 3rd stacked reparation elementary layer 1242 and the 4th reparation elementary layer 1244.4th repairs elementary layer 1244 is laminated on the second wearing layer 122.Concrete, the 4th repairs elementary layer 1244 is laminated in containing on minimum the second wear-resistant elements layer 1224 of the mass percentage of fortifying fibre.

3rd material repairing elementary layer 1242 comprises the mixture of polyether-ether-ketone and degradable first active bone repair material.Namely the first active bone repair material is mixed in polyether-ether-ketone.

Preferably, the 3rd polyether-ether-ketone in the material of elementary layer 1242 is repaired and the mass ratio of the first active bone repair material is 0.1 ~ 1:1.

Wherein, the 3rd polyether-ether-ketone repaired in the material of elementary layer 1242 is implantation level.Preferably, the particle diameter of polyether-ether-ketone is less than 40 microns.

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

Wherein, the microsphere containing bone-inducing factor can be the microsphere containing BMP-2 or the microsphere containing BMP-7.Wherein, that BMP represents is bone morphogenetic protein (Bonemorphogeneticprotein).Preferably, the material of microsphere is polylactic acid, alginate, chitosan or collagen etc.

Preferably, the particle diameter of the 3rd the first active bone repair material repaired in the material of elementary layer 1242 is 100 microns ~ 1 millimeter.

4th material repairing elementary layer 1144 is the mixture of polyether-ether-ketone and degradable second active bone repair material.

Wherein, the 4th polyether-ether-ketone repaired in the material of elementary layer 1144 is implantation level.And the particle diameter of polyether-ether-ketone is for being less than 40 microns.

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

When artificial intervertebral disk 100 is after implant into body, degradable first active bone repair material in 3rd reparation elementary layer 1242 and the 4th degradable second active bone repair material repaired in elementary layer 1244 can progressively be degraded, thus make the second repair layer 124 become a loose structure, freshman bone tissue can grow in this loose structure, combine closely to make osseous tissue and the second repair layer 124, after further guarantee artificial intervertebral disk 100 implant into body, the second soleplate 120 has long-time stability.

Preferably, the 4th reparation elementary layer 1244 is multiple, and multiple 4th reparation elementary layer 1244 stacks gradually on the second wearing layer 122.From the side of the second repair layer 124 to opposite side, the mass percentage of the multiple 4th the second active bone repair material repaired in the material of elementary layer 1244 reduces gradually.Arrange the multiple 4th and repair elementary layer 1244, and its second active bone repair material is reduced gradually, to make structure be in a transition stage, area of new bone is constantly grown into, in the hole stayed after being full of degraded, because the second active bone repair material is can by tissue degraded and absorbed, in degradation process, tissue generates new Bone Ingrowth by the position of the second active bone repair material before absorbing gradually, now, the component that can not degrade still plays the effect of a mechanical support, and can not cause in degradation process because degradable component and the layering of non-degradable component obviously destroy the structure of artificial intervertebral disk.

Concrete, minimum the 4th the repairing elementary layer 1244 and be laminated on the second wearing layer 122 of the mass percentage containing the second active bone repair material.

More specifically, containing minimum the 4th the repairing elementary layer 1244 and be laminated in containing on minimum the second wear-resistant elements layer 1224 of the mass percentage of fortifying fibre of the mass percentage of the second active bone repair material.

Preferably, repair in the material of elementary layer 1244 each 4th, the mass ratio of the second active bone repair material and polyether-ether-ketone is more than or equal to 0.005:1 and is less than 1:1.Under this proportion can have the prerequisite in certain hole after the degraded of guarantee second active bone repair material, still can uniform stressed.

Preferably, the 3rd repair polyether-ether-ketone in the material of elementary layer 1242 and the mass ratio of the first active bone repair material and be greater than the mass ratio that the 4th repairs the second active bone repair material in the material of elementary layer 1244 and polyether-ether-ketone.

Preferred, the 4th reparation elementary layer 1244 is 2 ~ 4.In the diagram of present embodiment, the 4th reparation elementary layer 1244 is 2.Be appreciated that in other embodiments, the 4th repairs elementary layer 1244 also can be 1 or be greater than 5.

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

When after above-mentioned artificial intervertebral disk 100 implant into body, to be slided with the arc-shaped concave 1222 of the second soleplate 120 by the arc convex 1122 of the first soleplate 110 and abut, to realize the relative sliding of the first soleplate 110 and the second soleplate 120, and the first soleplate 110 of above-mentioned artificial intervertebral disk 100 comprises the first wearing layer 112 and the first repair layer 114, second soleplate 120 comprises the second wearing layer 122 and the second repair layer 124, and the material of the material of the first wearing layer 112 and the second wearing layer 122 is polyether-ether-ketone and fortifying fibre mixture, and arc convex 1122 is positioned on the first wearing layer 112, arc-shaped concave 1222 is positioned on the second wearing layer 122, arc convex 1122 and arc-shaped concave 1222 is made all to have good anti-wear performance, abrasion loss amount is about 0.05 ~ 0.4mg/MC (MC represents 1,000,000 circulations), namely wear rate is 2% ~ 14.5% of the artificial intervertebral disk using merely polyether-ether-ketone to be material, well below the wear rate of Traditional Man intervertebral disc, because the arc convex 1122 of above-mentioned artificial intervertebral disk 100 all has good anti-wear performance with arc-shaped concave 1222, thus effectively reduce the generation of abrasive dust, add the life-span of above-mentioned artificial intervertebral disk 100, in addition, first repair layer 114 comprises the first stacked reparation elementary layer 1142 and second and repairs elementary layer 1144, second repairs elementary layer comprises the 3rd stacked reparation elementary layer 1242 and the 4th reparation elementary layer 1244, first material repairing elementary layer 1142 and the 3rd reparation elementary layer 1242 comprises polyether-ether-ketone and degradable first active bone repair material, second material repairing elementary layer 1144 and the 4th reparation elementary layer 1244 is the mixture of polyether-ether-ketone and degradable second active bone repair material, and due to the first active bone repair material be for by hydroxyapatite containing the microsphere of bone-inducing factor or the first active bone repair material, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass and the mixture of mixture sodium chloride composition formed containing the microsphere of bone-inducing factor, second active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass, after above-mentioned artificial intervertebral disk 100 is implanted, these active bone repair materials can be degraded, thus make the first repair layer 114 and the second repair layer 124 all become the structure of a porous, now, freshman bone tissue can grow in loose structure, osseous tissue can be combined with the first repair layer 114 and the second repair layer 124 respectively closely, add the long-time stability that the first soleplate 110 and the second soleplate 120 are implanting, namely ensure that the long-time stability of artificial intervertebral disk 100 after implant into body, therefore, after above-mentioned artificial intervertebral disk 100 implant into body, there is the longer life-span.

As shown in Figure 2, the preparation method of the artificial intervertebral disk of an embodiment, above-mentioned artificial intervertebral disk can use the preparation method of the artificial intervertebral disk of this embodiment to prepare, and the preparation method of this artificial intervertebral disk comprises the steps:

Step S310: mixed with polyether-ether-ketone by fortifying fibre, obtains the first mixed material.

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

Wherein, fortifying fibre is selected from least one in carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.

Preferably, the diameter of fortifying fibre is 1 nanometer ~ 50 micron, and length is 10 microns ~ 1000 microns.

Preferably, in step S310, fortifying fibre is specially from the step that polyether-ether-ketone mixes: fortifying fibre is mixed according to multiple different mass ratio respectively with polyether-ether-ketone, obtains multiple first mixed material.

In the particular embodiment, fortifying fibre and polyether-ether-ketone are mixed according to 3 ~ 10 different mass ratioes respectively, obtains 3 ~ 10 the first mixed materials.

Preferably, the fortifying fibre in each first mixed material and the mass ratio of polyether-ether-ketone are 0.001 ~ 0.5:1.

Preferred, in the first mixed material that the mass percentage containing fortifying fibre is maximum, the mass ratio of fortifying fibre and polyether-ether-ketone is 0.1:1 ~ 0.5:1.

Step S320: mixed with polyether-ether-ketone by the first additive, obtains the first composite material.Wherein, the first additive mixture that to be sodium chloride or the first additive be by least one in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and sodium chloride.

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

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

Step S330: mixed with polyether-ether-ketone by degradable active bone repair material, obtains the second composite material.

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

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

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

Preferably, in step S330, degradable active bone repair material is specially from the step that polyether-ether-ketone mixes: active bone repair material is mixed according to multiple different mass ratio respectively with polyether-ether-ketone, obtains multiple second composite material.

In the particular embodiment, active bone repair material and polyether-ether-ketone are mixed according to 2 ~ 4 different mass ratioes respectively, obtains 2 ~ 4 the second composite materials.

Preferably, the active bone repair material in each second composite material and the mass ratio of polyether-ether-ketone are more than or equal to 0.005:1 and are less than 1:1.

Step S340: the first mould is provided, first mould has the lower arcuate surface of evagination, first mixed material, the second composite material and the first composite material are added in the first mould successively, after molding, remove the first mould, through sintering, obtain stacking gradually first repairs elementary layer carcass, second repairs elementary layer and the first wearing layer, and the first wearing layer is formed with arc convex away from the side that second repairs elementary layer.

When the first mixed material and the second composite material are multiple, in step S340, the step that first mixed material, the second composite material and the first composite material add in the first mould is successively specially: the order first reduced gradually according to the mass percentage of fortifying fibre, successively multiple first mixed material is joined in the first mould, and then according to the order that the mass percentage of active bone repair material increases gradually, successively multiple second composite material is joined in the first mould, then add the first composite material.Wherein, the bottom of the first mould is joined containing the first mixed material that the mass percentage of fortifying fibre is maximum.

Concrete, the forming method used in step S340 is cold moudling; Wherein, forming step is specially: in the cold state, has the first mould pressurizing of the first mixed material, the first composite material and the second composite material to 110MPa ~ 250MPa, pressurize 10 minutes ~ 20 minutes by adding.

Concrete, the sintering step in step S340 is specially: by the first sample blanks of obtaining after removal first mould prior to 355 DEG C ~ 400 DEG C of heat preservation sinterings 20 minutes ~ 30 minutes, and then in 220 DEG C ~ 280 DEG C heat preservation sinterings 1 hour ~ 2 hours.By the first sample blanks first at 355 DEG C ~ 400 DEG C heat preservation sinterings, and then at 220 DEG C ~ 280 DEG C heat preservation sinterings, it is the Growing Process of Crystal Particles in order to avoid sintering the later stage, by first sintering temperature being risen to higher temperature, be in molten condition, removing bubble, makes the relative density of sample blanks reach about 70%; Then, when being incubated longer under sintering temperature being dropped to lower temperature, chien shih sintering proceeds, and realizes densification completely.This one-phase crystal grain does not obviously grow.Two-step sintering method is the change by control temperature cleverly, while suppression crystal boundary migration (this will cause grain growth), keep grain boundary decision (this is the power of blank Densification) to be in active state, under realizing the prerequisite of not growing up at crystal grain, complete the object of sintering.

Step S350: sodium chloride on the surface of elementary layer carcass is repaired in cleaning removal first, to be then adsorbed to the microsphere containing bone-inducing factor on the first reparation elementary layer carcass to form the first reparation elementary layer, to obtain the first soleplate.

Wherein, in step S350, the microsphere containing bone-inducing factor is also degradable active bone repair material.Wherein, the microsphere containing bone-inducing factor can be the microsphere containing BMP-2 or the microsphere containing BMP-7.Wherein, that BMP represents is bone morphogenetic protein (Bonemorphogeneticprotein).

Concrete, the particle diameter of the sodium chloride used in step S320 is more than or equal to the particle diameter of the microsphere containing bone-inducing factor in step S350.Wherein, the particle diameter containing the microsphere of bone-inducing factor is 100 microns ~ 1 millimeter.

Wherein, the step of the sodium chloride that cleaning removal first is repaired on the surface of elementary layer carcass is specially: adopt water to clean the first repair layer, to remove the sodium chloride on the surface of the first reparation elementary layer carcass, now, the first surface of repairing elementary layer carcass forms loose structure.

Wherein, will be adsorbed to be formed in the step of the first reparation elementary layer on the first reparation elementary layer carcass containing the microsphere of bone-inducing factor, the microsphere containing bone-inducing factor being adsorbed to what the first reparation elementary layer carcass adopted is static adsorptive method.

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

Preferred, the first mass ratio repairing polyether-ether-ketone in elementary layer and active bone repair material is greater than the mass ratio of active bone repair material in the second reparation elementary layer and polyether-ether-ketone.

Step S360: mixed with polyether-ether-ketone by fortifying fibre, obtains the second mixed material.

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

Wherein, fortifying fibre is selected from least one in carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.Preferably, the diameter of fortifying fibre is 1 nanometer ~ 50 micron, and length is 10 microns ~ 1000 microns.

Preferably, in step S360, fortifying fibre is specially from the step that polyether-ether-ketone mixes: fortifying fibre is mixed according to multiple different mass ratio respectively with polyether-ether-ketone, obtains multiple second mixed material.

In the particular embodiment, fortifying fibre and polyether-ether-ketone are mixed according to 3 ~ 10 different mass ratioes respectively, obtains 3 ~ 10 the second mixed materials.

Preferably, the fortifying fibre in each second mixed material and the mass ratio of polyether-ether-ketone are 0.001 ~ 0.5:1.

Preferred, the mass ratio containing the fortifying fibre in the second mixed material that the mass percentage of fortifying fibre is maximum and polyether-ether-ketone is 0.1:1 ~ 0.5:1.

Step S370: mixed with polyether-ether-ketone by Second addition, obtains the 3rd composite material.Second addition is sodium chloride or Second addition is the mixture be made up of at least one in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass and sodium chloride.

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

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

Step S380: mixed with polyether-ether-ketone by degradable active bone repair material, obtains the 4th composite material.

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

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

Preferably, in step S380, degradable active bone repair material is specially from the step that polyether-ether-ketone mixes: active bone repair material is mixed according to multiple different mass ratio respectively with polyether-ether-ketone, obtains multiple 4th composite material.In the particular embodiment, active bone repair material and polyether-ether-ketone are mixed according to 2 ~ 4 different mass ratioes respectively, obtains 2 ~ 4 the second composite materials.

Preferably, the active bone repair material in each 4th composite material and the mass ratio of polyether-ether-ketone are more than or equal to 0.005:1 and are less than 1:1.

Step S390: the second mould is provided, second mould has the lower arcuate surface of indent, second mixed material, the 4th composite material and the 3rd composite material are added in the second mould successively, after molding, remove the second mould, through sintering, the obtain stacking gradually the 3rd repairs elementary layer carcass, the 4th repairs elementary layer and the second wearing layer, and the second wearing layer is formed with arc-shaped concave away from the side that the 4th repairs elementary layer.And arc convex slidably abuts with arc-shaped concave.

When the second mixed material and the 4th composite material are multiple, in step S390, the step that second mixed material, the 4th composite material and the 3rd composite material add in the second mould is successively specially: the order first reduced gradually according to the mass percentage of fortifying fibre, successively multiple second mixed material is joined in the second mould, and then according to the order that the mass percentage of active bone repair material increases gradually, successively multiple 4th composite material is joined in the second mould, then add the 3rd composite material.Wherein, the bottom of the second mould is joined containing the second mixed material that the mass percentage of fortifying fibre is maximum.

Concrete, the forming method used in step S390 is cold moudling; Wherein, forming step is specially: in the cold state, has the second mould pressurizing of the second mixed material, the 4th composite material and the 3rd composite material to 110MPa ~ 250MPa, pressurize 10 minutes ~ 20 minutes by adding.

Concrete, the sintering step in step S390 is specially: by the second sample blanks of obtaining after removal second mould prior to 355 DEG C ~ 400 DEG C of heat preservation sinterings 20 minutes ~ 30 minutes, and then in 220 DEG C ~ 280 DEG C heat preservation sinterings 1 hour ~ 2 hours.By the second sample blanks first at 355 DEG C ~ 400 DEG C heat preservation sinterings, and then at 220 DEG C ~ 280 DEG C heat preservation sinterings, it is the Growing Process of Crystal Particles in order to avoid sintering the later stage, by first sintering temperature being risen to higher temperature, be in molten condition, removing bubble, makes the relative density of sample blanks reach about 70%; Then, when being incubated longer under sintering temperature being dropped to lower temperature, chien shih sintering proceeds, and realizes densification completely.This one-phase crystal grain does not obviously grow.Two-step sintering method is the change by control temperature cleverly, while suppression crystal boundary migration (this will cause grain growth), keep grain boundary decision (this is the power of blank Densification) to be in active state, under realizing the prerequisite of not growing up at crystal grain, complete the object of sintering.

Step S400: the sodium chloride on the surface of elementary layer carcass is repaired in cleaning removal the 3rd, is then adsorbed to the microsphere containing bone-inducing factor on the 3rd reparation elementary layer carcass and repairs elementary layer to form the 3rd, obtain the second soleplate.

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

Concrete, the particle diameter of the sodium chloride used in step S370 is more than or equal to the particle diameter of the microsphere containing bone-inducing factor in step S400.Wherein, the particle diameter containing the microsphere of bone-inducing factor is 100 microns ~ 1 millimeter.

Wherein, the step of the sodium chloride that cleaning removal the 3rd is repaired on the surface of elementary layer carcass is specially: adopt water to clean the second repair layer, to remove the sodium chloride on the surface of the 3rd reparation elementary layer carcass, now, the 3rd surface of repairing elementary layer carcass forms loose structure.

Wherein, repair on elementary layer carcass and repair in the step of elementary layer by being adsorbed to the 3rd containing the microsphere of bone-inducing factor to form the 3rd, the microsphere containing bone-inducing factor being adsorbed to the 3rd, to repair what elementary layer carcass adopted be static adsorptive method.

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

Preferred, the 3rd mass ratio repairing polyether-ether-ketone in elementary layer and the first active bone repair material is greater than the mass ratio of active bone repair material in the second reparation elementary layer and polyether-ether-ketone.

After step S350 and step S400, also comprise and respectively the first soleplate and the second soleplate cleaned, dry, pack and the step of sterilizing.

Be appreciated that in concrete operating process, be not limited only to adopt said sequence to prepare, can also adopt other order, such as, step S310 and step S320 can reversed order; Or, first can carry out step S360 ~ S400, then carry out step S310 ~ S350 etc.

The preparation method of above-mentioned artificial intervertebral disk is simple, is applicable to suitability for industrialized production.

Be below detailed description of the invention part:

Embodiment 1

The artificial intervertebral disk of the present embodiment is prepared as follows:

(1) be 0.1:1 according to mass ratio, mixed with the polyether-ether-ketone implanting level by fortifying fibre, obtain the first mixed material, wherein, fortifying fibre is glass fibre, and diameter is 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(2) mixed with the polyether-ether-ketone implanting level by the first additive, obtain the first composite material, wherein, the first additive is type alpha tricalcium phosphate and two kinds, 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) be 0.3:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the second composite material, 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, first mould has the lower arcuate surface of evagination, by the first mixed material, second composite material and the first composite material join in the first mould successively, wherein, first mixed material joins the bottom of the first mould, then to 110MP, cold moudling is carried out to the first mould pressurizing, pressurize 20 minutes, remove the first mould, then prior to 355 DEG C of heat preservation sinterings 30 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the first stacked reparation elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, the thickness of the first wearing layer is 50 microns, first wearing layer is formed with arc convex away from the side that second repairs elementary layer.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, static adsorptive method is adopted to be adsorbed in the first reparation elementary layer carcass by the microsphere containing BMP-2, the gross mass of microsphere of type alpha tricalcium phosphate in elementary layer and BMP-2 and the mass ratio of polyether-ether-ketone is repaired for 0.5:1 with make to obtain first, namely the first soleplate is obtained, wherein, the material of microsphere is polylactic acid, and particle diameter is 100 microns.

(6) be 0.1:1 according to mass ratio, mixed with the polyether-ether-ketone implanting level by fortifying fibre, obtain the second mixed material, wherein, fortifying fibre is glass fibre, and diameter is 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(7) mixed with the polyether-ether-ketone implanting level by Second addition, obtain the 3rd composite material, wherein, Second addition is type alpha tricalcium phosphate and two kinds, 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) be 0.3:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the 4th composite material, 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, second mould has the lower arcuate surface of evagination, by the second mixed material, 4th composite material and the 3rd composite material join in the second mould successively, wherein, second mixed material joins the bottom of the second mould, then to 110MP, cold moudling is carried out to the second mould pressurizing, pressurize 20 minutes, remove the second mould, then prior to 355 DEG C of heat preservation sinterings 30 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd stacked reparation elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, the thickness of the second wearing layer is 50 microns, and the second wearing layer is formed with arc-shaped concave away from the side that the 4th repairs elementary layer.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, adopting static adsorptive method the microsphere containing BMP-2 to be adsorbed to the 3rd repairs in elementary layer carcass, the gross mass of microsphere of type alpha tricalcium phosphate in elementary layer and BMP-2 and the mass ratio of polyether-ether-ketone is repaired for 0.5:1 with the make to obtain the 3rd, namely the second soleplate is obtained, wherein, the material of microsphere is polylactic acid, and particle diameter is 100 microns.

Thus obtain the artificial intervertebral disk of the present embodiment.Then respectively local repair, cleaning, oven dry, packaging and sterilizing are carried out to the first soleplate and the second soleplate.

According to the frictional behaviour test that the arc-shaped concave of method to the arc convex of the first soleplate and the second soleplate of ISO18192-1 or ASTMF2423 carries out, by the arc convex of first soleplate of the present embodiment and the arc-shaped concave of the second soleplate after the friction of 1,000,000 times, obtain the wear extent of the artificial intervertebral disk of the present embodiment in table 1.

Method according to ISO527 carries out elastic modelling quantity test to the artificial intervertebral disk of the present embodiment, and the elastic modelling quantity of the present embodiment is in table 1.

Embodiment 2

(1) be 0.1:1,0.08:1 and 0.06:1 according to mass ratio respectively, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the first mixed material 1, first mixed material 2 and the first mixed material 3, wherein, fortifying fibre is carbon fiber, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber five kinds, the diameter of fortifying fibre is 1 nanometer, and length is 10 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(2) the first additive is mixed with the polyether-ether-ketone implanting level, obtain the first composite material, wherein, first additive is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate, bioactivity glass and sodium chloride, the particle diameter of hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and bioactivity glass is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(3) be 0.2:1 and 0.3:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the second composite material 1 and the second composite material 2, wherein, active bone repair material is three kinds, hydroxyapatite, bata-tricalcium phosphate and calcium sulfate, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(4) the first mould is provided, first mould has the lower arcuate surface of evagination, by the first mixed material 1, first mixed material 2, first mixed material 3, second composite material 1, second composite material 2 and the first composite material join in the first mould, wherein, first mixed material 1 joins the bottom of the first mould, then to 200MP, cold moudling is carried out to the first mould pressurizing, pressurize 15 minutes, remove the first mould, then prior to 400 DEG C of heat preservation sinterings 20 minutes, again in 280 DEG C of heat preservation sinterings 1 hour, obtain stacking gradually first repairs elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, first wearing layer is formed with arc convex away from the side that second repairs elementary layer, first wearing layer has three the first wear-resistant elements layers stacked gradually, and be 100 microns away from the second thickness repairing the first wear-resistant elements layer of elementary layer, second reparation elementary layer is two.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, particle diameter is that the microsphere containing BMP-7 of 200 microns is adsorbed in the first reparation elementary layer carcass by employing static adsorptive method, repair with make to obtain first the hydroxyapatite in elementary layer, bata-tricalcium phosphate, calcium sulfate, bioactivity glass and containing the gross mass of microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 0.4:1, namely the first soleplate is obtained, wherein, the material of microsphere is alginate.

(6) be 0.1:1,0.08:1 and 0.06:1 according to mass ratio respectively, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the second mixed material 1, second mixed material 2 and the second mixed material 3, wherein, fortifying fibre is carbon fiber, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber five kinds, the diameter of fortifying fibre is 1 nanometer, and length is 10 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(7) Second addition is mixed with the polyether-ether-ketone implanting level, obtain the 3rd composite material, wherein, Second addition is five kinds, hydroxyapatite, bata-tricalcium phosphate, calcium sulfate, bioactivity glass and sodium chloride, the particle diameter of hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and bioactivity glass is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(8) be 0.2:1 and 0.3:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the 4th composite material 1 and the 4th composite material 2, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and bioactivity glass four kinds, and particle diameter is 200 microns.

(9) the second mould is provided, second mould has the lower arcuate surface of indent, by the second mixed material 1, second mixed material 2, second mixed material 3, 4th composite material 1, 4th composite material 2 and the 3rd composite material join in the second mould successively, wherein, second mixed material 1 joins the bottom of the second mould, then to 200MP, cold moudling is carried out to the second mould pressurizing, pressurize 15 minutes, remove the second mould, then prior to 400 DEG C of heat preservation sinterings 20 minutes, again in 280 DEG C of heat preservation sinterings 1 hour, obtain stacking gradually the 3rd repairs elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, second wearing layer is formed with arc-shaped concave away from the side that the 4th repairs elementary layer, second wearing layer has three the second wear-resistant elements layers stacked gradually, thickness away from the second wear-resistant elements layer of the 4th reparation elementary layer is 100 microns, and the 4th reparation elementary layer is two.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, employing static adsorptive method particle diameter is that the microsphere containing BMP-7 of 200 microns is adsorbed in the 3rd reparation elementary layer carcass, repair with the make to obtain the 3rd the hydroxyapatite in elementary layer, bata-tricalcium phosphate, calcium sulfate, bioactivity glass and containing the gross mass of microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 0.4:1, namely the second soleplate is obtained, wherein, the material of microsphere is alginate.

Embodiment 3

(1) be 0.1:1 according to mass ratio respectively, 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, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5, first mixed material 6, first mixed material 7, first mixed material 8, first mixed material 9 and the first mixed material 10, wherein, fortifying fibre is graphite fibre and silicon carbide fibre two kinds, the diameter of fortifying fibre is 1 nanometer, length is 1000 microns, the particle diameter of polyether-ether-ketone is 25 microns.

(2) the first additive is mixed with the polyether-ether-ketone implanting level, obtain the first composite material, wherein, first additive is four kinds, hydroxyapatite, calcium sulfate, bioactivity glass and sodium chloride, the particle diameter of hydroxyapatite, calcium sulfate and bioactivity glass is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(3) be 0.1:1,0.2:1,0.3:1 and 0.4:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the second composite material 1, second composite material 2, second composite material 3 and the second composite material 4 respectively, active bone repair material is hydroxyapatite, calcium sulfate and bioactivity glass three kinds, particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(4) provide the first mould, the first mould has the lower arcuate surface of evagination, successively by the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5, first mixed material 6, first mixed material 7, first mixed material 8, first mixed material 9, first mixed material 10, second composite material 1, second composite material 2, second composite material 3, second composite material 4 and the first composite material join in the first mould successively, wherein, first mixed material 1 joins the bottom of the first mould, then to 250MP, cold moudling is carried out to the first mould pressurizing, pressurize 10 minutes, removes the first mould, then prior to 380 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain stacked first and repair elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, first wearing layer is formed with arc convex away from the side of the second repair layer carcass, first wearing layer has ten the first wear-resistant elements layers stacked gradually, wherein, thickness away from the first wear-resistant elements layer of the second reparation elementary layer is 100 microns, and the second reparation elementary layer is four.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, particle diameter is that the microsphere containing BMP-7 of 1 millimeter is adsorbed on the first reparation elementary layer carcass by employing static adsorptive method, repair with make to obtain first the hydroxyapatite in elementary layer, calcium sulfate, bioactivity glass and containing the gross mass of microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 0.5:1, namely obtain the first soleplate, the material of microsphere is chitosan.

(6) be 0.1:1 according to mass ratio respectively, 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, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5, second mixed material 6, second mixed material 7, second mixed material 8, second mixed material 9 and the second mixed material 10, wherein, fortifying fibre is graphite fibre and silicon carbide fibre two kinds, the diameter of fortifying fibre is 1 nanometer, length is 1000 microns, the particle diameter of polyether-ether-ketone is 25 microns.

(7) Second addition is mixed with the polyether-ether-ketone implanting level, obtain the 3rd composite material, wherein, Second addition is hydroxyapatite, calcium sulfate, bioactivity glass and sodium chloride, the particle diameter of hydroxyapatite, calcium sulfate and bioactivity glass is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(8) be 0.1:1,0.2:1,0.3:1 and 0.4:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the 4th composite material 1, the 4th composite material 2, the 4th composite material 3 and the 4th composite material 4 respectively, active bone repair material is hydroxyapatite, calcium sulfate and bioactivity glass three kinds, particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(9) provide the second mould, the second mould has the lower arcuate surface of indent, by the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5, second mixed material 6, second mixed material 7, second mixed material 8, second mixed material 9, second mixed material 10, 4th composite material 1, 4th composite material 2, 4th composite material 3, 4th composite material 4 and the 3rd composite material join in the second mould successively, wherein, second mixed material 1 joins the bottom of the first mould, then to 250MP, cold moudling is carried out to the first mould pressurizing, pressurize 10 minutes, removes the second mould, then prior to 380 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd and repair elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, second wearing layer is formed with arc-shaped concave away from the side of the second repair layer carcass, second wearing layer has ten the second wear-resistant elements layers stacked gradually, wherein, thickness away from the second wear-resistant elements layer of the 4th reparation elementary layer is 100 microns, and the 4th reparation elementary layer is four.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, particle diameter is that the microsphere containing BMP-7 of 1 millimeter is adsorbed in the 3rd reparation elementary layer carcass by employing static adsorptive method, repair with the make to obtain the 3rd the hydroxyapatite in elementary layer, calcium sulfate, bioactivity glass and containing the gross mass of microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 0.5:1, namely obtain the second soleplate, the material of microsphere is chitosan.

Embodiment 4

(1) be 0.5:1,0.4:1,0.3:1,0.2:1,0.1:1 and 0.05:1 according to mass ratio respectively, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5 and the first mixed material 6, wherein, fortifying fibre is silicon carbide fibre, diameter is 50 microns, and length is 500 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(2) the first additive is mixed with the polyether-ether-ketone implanting level, obtain the first composite material, wherein, first additive is three kinds, hydroxyapatite, bioactivity glass and sodium chloride, the particle diameter of hydroxyapatite and bioactivity glass is 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(3) be 0.2:1,0.3:1 and 0.4:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the second composite material 1, second composite material 2 and the second composite material 3 respectively, wherein, active bone repair material is hydroxyapatite and bioactivity glass, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(4) the first mould is provided, first mould has the lower arcuate surface of evagination, successively by the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5, first mixed material 6, second composite material 1, second composite material 2, second composite material 3 and the first composite material join in the first mould successively, wherein, first mixed material 1 joins the bottom of the first mould, then to 200MP, cold moudling is carried out to the first mould pressurizing, pressurize 15 minutes, remove the first mould, then prior to 355 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the first stacked reparation elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, first wearing layer is formed with arc convex away from the side of the second repair layer carcass, first wearing layer has six the first wear-resistant elements layers stacked gradually, wherein, thickness away from the first wear-resistant elements layer of the second reparation elementary layer is 50 microns, second reparation elementary layer is three.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, particle diameter is that the microsphere containing BMP-2 of 200 microns is adsorbed on the first reparation elementary layer carcass by employing static adsorptive method, repair with make to obtain first the hydroxyapatite in elementary layer, bioactivity glass and containing the gross mass of microsphere of BMP-2 and the mass ratio of polyether-ether-ketone for 0.5:1, namely the first soleplate is obtained, wherein, the material of microsphere is chitosan.

(6) be 0.5:1,0.4:1,0.3:1,0.2:1,0.1:1 and 0.05:1 according to mass ratio respectively, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5 and the second mixed material 6, wherein, fortifying fibre is silicon carbide fibre, diameter is 50 microns, and length is 500 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(7) Second addition is mixed with the polyether-ether-ketone implanting level, obtain the 3rd composite material, wherein, Second addition is three kinds, hydroxyapatite, bioactivity glass and sodium chloride, the particle diameter of hydroxyapatite and bioactivity glass is 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(8) be 0.2:1,0.3:1 and 0.4:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the 4th composite material 1, the 4th composite material 2 and the 4th composite material 3 respectively, wherein, active bone repair material is hydroxyapatite and bioactivity glass, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(9) the second mould is provided, second mould has the lower arcuate surface of indent, by the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5, second mixed material 6, 4th composite material 1, 4th composite material 2, 4th composite material 3 and the 3rd composite material join in the second mould successively, wherein, second mixed material 1 joins the bottom of the first mould, then to 200MP, cold moudling is carried out to the first mould pressurizing, pressurize 15 minutes, remove the second mould, then prior to 355 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd and repair elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, second wearing layer is formed with arc-shaped concave away from the side of the 4th repair layer carcass, second wearing layer has six the second wear-resistant elements layers stacked gradually, wherein, thickness away from the second wear-resistant elements layer of the 4th reparation elementary layer is 50 microns, and the 4th reparation elementary layer is three.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, particle diameter is that the BMP-2 that contains of 200 microns is adsorbed in the 3rd reparation elementary layer carcass by employing static adsorptive method, repair with make to obtain first the hydroxyapatite in elementary layer, bioactivity glass and containing the gross mass of microsphere of BMP-2 and the mass ratio of polyether-ether-ketone for 0.5:1, namely the second soleplate is obtained, wherein, the material of microsphere is chitosan.

Embodiment 5

(1) be 0.1:1 according to mass ratio, fortifying fibre mixes with the polyether-ether-ketone implanting level, and obtain the first mixed material, wherein, fortifying fibre is glass fibre, and diameter is 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(2) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the first composite material, wherein, the particle diameter of polyether-ether-ketone is 30 microns.

(3) be 0.2:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the second composite material, wherein, active bone repair material is type alpha tricalcium phosphate, and particle diameter is 100 microns, and particle diameter is 30 microns.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, static adsorptive method is adopted to be adsorbed in the first reparation elementary layer carcass by the microsphere containing BMP-2, with make to obtain first repair in elementary layer containing the microsphere of BMP-2 and the mass ratio of polyether-ether-ketone for 0.4:1, namely the first soleplate is obtained, wherein, the material of microsphere is polylactic acid, and particle diameter is 100 microns.

(6) be 0.1:1 according to mass ratio respectively, mixed with the polyether-ether-ketone implanting level by fortifying fibre, obtain the second mixed material, wherein, fortifying fibre is glass fibre, and diameter is 50 microns, and length is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(7) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the 3rd composite material, wherein, the particle diameter of polyether-ether-ketone is 30 microns.

(8) be 0.2:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the 4th composite material, 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, second mould has the lower arcuate surface of evagination, by the second mixed material, 4th composite material and the 3rd composite material join in the second mould successively, wherein, second mixed material joins the bottom of the second mould, then to 110MP, cold moudling is carried out to the second mould pressurizing, pressurize 20 minutes, remove the second mould, then prior to 355 DEG C of heat preservation sinterings 30 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd stacked reparation elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, the thickness of the second wearing layer is 50 microns, and the second wear-resistant elements layer is formed with arc-shaped concave away from the side that the 4th repairs elementary layer.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, adopting static adsorptive method the microsphere containing BMP-2 to be adsorbed to the 3rd repairs in elementary layer carcass, with the make to obtain the 3rd repair in elementary layer containing the microsphere of BMP-2 and the mass ratio of polyether-ether-ketone for 0.4:1, namely the second soleplate is obtained, wherein, the material of microsphere is polylactic acid, and particle diameter is 100 microns.

Embodiment 6

(2) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the first composite material, wherein, the particle diameter of polyether-ether-ketone is 20 microns.

(3) be 0.8:1 and 0.9:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the second composite material 1 and the second composite material 2, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and bioactivity glass four kinds, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 20 microns.

(4) the first mould is provided, first mould has the lower arcuate surface of evagination, by the first mixed material 1, first mixed material 2, first mixed material 3, second composite material 1, second composite material 2 and the first composite material join in the first mould, wherein, first mixed material 1 joins the bottom of the first mould, then to 200MP, cold moudling is carried out to the first mould pressurizing, pressurize 15 minutes, remove the first mould, then prior to 400 DEG C of heat preservation sinterings 20 minutes, again in 280 DEG C of heat preservation sinterings 1 hour, obtain stacking gradually first repairs elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, first wear-resistant elements layer is formed with arc convex away from the side that second repairs elementary layer, first wearing layer has three the first wear-resistant elements layers stacked gradually, and be 100 microns away from the second thickness repairing the first wear-resistant elements layer of elementary layer, second reparation elementary layer is two.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, particle diameter is that the microsphere containing BMP-7 of 200 microns is adsorbed in the first reparation elementary layer carcass by employing static adsorptive method, with make to obtain first repair in elementary layer containing the microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 1:1, namely the first soleplate is obtained, wherein, the material of microsphere is alginate.

(7) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the 3rd composite material, wherein, the particle diameter of polyether-ether-ketone is 20 microns.

(8) be 0.8:1 and 0.9:1 according to mass ratio, by active bone repair material and polyether-ether-ketone mixing, obtain the 4th composite material 1 and the 4th composite material 2, wherein, active bone repair material is hydroxyapatite, bata-tricalcium phosphate, calcium sulfate and bioactivity glass four kinds, and particle diameter is 200 microns.

(9) the second mould is provided, second mould has the lower arcuate surface of indent, by the second mixed material 1, second mixed material 2, second mixed material 3, 4th composite material 1, 4th composite material 2 and the 3rd composite material join in the second mould successively, wherein, second mixed material 1 joins the bottom of the second mould, then to 200MP, cold moudling is carried out to the second mould pressurizing, pressurize 15 minutes, remove the second mould, then prior to 400 DEG C of heat preservation sinterings 20 minutes, again in 280 DEG C of heat preservation sinterings 1 hour, obtain stacking gradually the 3rd repairs elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, second wear-resistant elements layer is formed with arc-shaped concave away from the side that the 4th repairs elementary layer, second wearing layer has three the second wear-resistant elements layers stacked gradually, and be 100 microns away from the 4th thickness repairing the second wear-resistant elements layer of elementary layer, 4th reparation elementary layer is two.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, employing static adsorptive method particle diameter is that the microsphere containing BMP-7 of 200 microns is adsorbed in the 3rd reparation elementary layer carcass, with the make to obtain the 3rd repair in elementary layer containing the microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 1:1, namely the second soleplate is obtained, wherein, the material of microsphere is alginate.

Embodiment 7

(1) be 0.1:1 according to mass ratio respectively, 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, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5, first mixed material 6, first mixed material 7, first mixed material 8, first mixed material 9 and the first mixed material 10, wherein, fortifying fibre is graphite fibre and silicon carbide fibre, the diameter of fortifying fibre is 1 nanometer, length is 1000 microns, the particle diameter of polyether-ether-ketone is 25 microns.

(2) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the first composite material, wherein, the particle diameter of polyether-ether-ketone is 25 microns.

(3) be 0.05:1,0.10:1,0.15:1 and 0.20:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the second composite material 1, second composite material 2, second composite material 3 and the second composite material 4 respectively, active bone repair material is hydroxyapatite, calcium sulfate and bioactivity glass three kinds, particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(4) provide the first mould, the first mould has the lower arcuate surface of evagination, successively by the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5, first mixed material 6, first mixed material 7, first mixed material 8, first mixed material 9, first mixed material 10, second composite material 1, second composite material 2, second composite material 3, second composite material 4 and the first composite material join in the first mould successively, wherein, first mixed material 1 joins the bottom of the first mould, then to 250MP, cold moudling is carried out to the first mould pressurizing, pressurize 10 minutes, removes the first mould, then prior to 380 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain stacked first and repair elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, first wearing layer is formed with arc convex away from the side of the first repair layer carcass, first wearing layer has ten the first wear-resistant elements layers stacked gradually, wherein, thickness away from the first wear-resistant elements layer of the second reparation elementary layer is 50 microns, and the second reparation elementary layer is four.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, particle diameter is that the microsphere containing BMP-7 of 1 millimeter is adsorbed on the first reparation elementary layer carcass by employing static adsorptive method, with make to obtain first repair in elementary layer containing the microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 0.25:1, namely obtain the first soleplate, the material of microsphere is chitosan.

(7) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the 3rd composite material, wherein, the particle diameter of polyether-ether-ketone is 25 microns.

(8) be 0.05:1,0.10:1,0.15:1 and 0.20:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the 4th composite material 1, the 4th composite material 2, the 4th composite material 3 and the 4th composite material 4 respectively, active bone repair material is hydroxyapatite, calcium sulfate and bioactivity glass three kinds, particle diameter is 1 millimeter, and the particle diameter of polyether-ether-ketone is 25 microns.

(9) provide the second mould, the second mould has the lower arcuate surface of indent, by the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5, second mixed material 6, second mixed material 7, second mixed material 8, second mixed material 9, second mixed material 10, 4th composite material 1, 4th composite material 2, 4th composite material 3, 4th composite material 4 and the 3rd composite material join in the second mould successively, wherein, second mixed material 1 joins the bottom of the first mould, then to 250MP, cold moudling is carried out to the first mould pressurizing, pressurize 10 minutes, removes the second mould, then prior to 355 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd and repair elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, second wearing layer is formed with arc-shaped concave away from the side of the first repair layer carcass, second wearing layer has ten the second wear-resistant elements layers stacked gradually, wherein, thickness away from the second wear-resistant elements layer of the 4th reparation elementary layer is 50 microns, and the 4th reparation elementary layer is four.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, particle diameter is that the microsphere containing BMP-7 of 1 millimeter is adsorbed in the 3rd reparation elementary layer carcass by employing static adsorptive method, with the make to obtain the 3rd repair in elementary layer containing the microsphere of BMP-7 and the mass ratio of polyether-ether-ketone for 0.25:1, namely obtain the second soleplate, the material of microsphere is chitosan.

Embodiment 8

(1) be 0.5:1,0.45:1,0.40:1,0.35:1,0.30.1:1 and 0.25:1 according to mass ratio respectively, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5 and the first mixed material 6, wherein, fortifying fibre is silicon carbide fibre, diameter is 50 microns, and length is 500 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(2) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the first composite material, wherein, the particle diameter of polyether-ether-ketone is 10 microns.

(3) be 0.04:1,0.06:1 and 0.08:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the second composite material 1, second composite material 2 and the second composite material 3 respectively, wherein, active bone repair material is hydroxyapatite and bioactivity glass, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(4) the first mould is provided, first mould has the lower arcuate surface of evagination, successively by the first mixed material 1, first mixed material 2, first mixed material 3, first mixed material 4, first mixed material 5, first mixed material 6, second composite material 1, second composite material 2, second composite material 3 and the first composite material join in the first mould successively, wherein, first mixed material 1 joins the bottom of the first mould, then to 200MP, cold moudling is carried out to the first mould pressurizing, pressurize 15 minutes, remove the first mould, then prior to 355 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the first stacked reparation elementary layer carcass, second repairs elementary layer and the first wearing layer, wherein, first wearing layer is formed with arc convex away from the side of the first repair layer carcass, first wearing layer has six the first wear-resistant elements layers stacked gradually, wherein, thickness away from the first wear-resistant elements layer of the second reparation elementary layer is 100 microns, second reparation elementary layer is three.

(5) clean with water to remove the sodium chloride on the first reparation elementary layer carcass surface, particle diameter is that the microsphere containing BMP-2 of 200 microns is adsorbed on the first reparation elementary layer carcass by employing static adsorptive method, with make to obtain first repair in elementary layer containing the microsphere of BMP-2 and the mass ratio of polyether-ether-ketone for 0.1:1, namely the first soleplate is obtained, wherein, the material of microsphere is chitosan.

(6) be 0.5:1,0.45:1,0.40:1,0.35:1,0.30.1:1 and 0.25:1 according to mass ratio respectively, fortifying fibre is mixed with the polyether-ether-ketone implanting level, obtain the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5 and the second mixed material 6, wherein, fortifying fibre is silicon carbide fibre, diameter is 50 microns, and length is 500 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(7) mixed with the polyether-ether-ketone implanting level by sodium chloride, obtain the 3rd composite material, wherein, the particle diameter of polyether-ether-ketone is 10 microns.

(8) be 0.04:1,0.06:1 and 0.08:1 according to mass ratio, active bone repair material is mixed with polyether-ether-ketone, obtain the 4th composite material 1, the 4th composite material 2 and the 4th composite material 3 respectively, wherein, active bone repair material is hydroxyapatite and bioactivity glass, particle diameter is 200 microns, and the particle diameter of polyether-ether-ketone is 10 microns.

(9) the second mould is provided, second mould has the lower arcuate surface of indent, by the second mixed material 1, second mixed material 2, second mixed material 3, second mixed material 4, second mixed material 5, second mixed material 6, 4th composite material 1, 4th composite material 2, 4th composite material 3 and the 3rd composite material join in the second mould successively, wherein, second mixed material 1 joins the bottom of the first mould, then to 200MP, cold moudling is carried out to the first mould pressurizing, pressurize 15 minutes, remove the second mould, then prior to 355 DEG C of heat preservation sinterings 25 minutes, again in 220 DEG C of heat preservation sinterings 2 hours, obtain the 3rd and repair elementary layer carcass, 4th repairs elementary layer and the second wearing layer, wherein, second wearing layer is formed with arc-shaped concave away from the side of the first repair layer carcass, second wearing layer has six the second wear-resistant elements layers stacked gradually, wherein, thickness away from the second wear-resistant elements layer of the 4th reparation elementary layer is 100 microns, 4th reparation elementary layer is three.

(10) clean with the sodium chloride removed on the 3rd reparation elementary layer carcass surface with water, particle diameter is that the BMP-2 that contains of 200 microns is adsorbed in the 3rd reparation elementary layer carcass by employing static adsorptive method, with the make to obtain the 3rd repair in elementary layer containing the microsphere of BMP-2 and the mass ratio of polyether-ether-ketone for 0.1:1, namely the second soleplate is obtained, wherein, the material of microsphere is chitosan.

Table 1 represent be through the friction of 1,000,000 times after, the wear extent of the artificial intervertebral disk of embodiment 1 ~ embodiment 8 and comparative example 1 and elastic modelling quantity.Wherein, comparative example 1 is traditional only employing polyether-ether-ketone is the artificial intervertebral disk of material.

Table 1

	Wear extent	Elastic modelling quantity
			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 can be seen from Table 1, the wear extent of the artificial intervertebral disk of embodiment 1 ~ embodiment 8 mostly is 0.4mg/MC most, minimum only have 0.05mg/MC, and the wear extent of traditional artificial intervertebral disk of comparative example 1 is 2.5mg/MC, namely the wear extent of the artificial intervertebral disk of embodiment 1 ~ 8 is only 2.0% ~ 14.5% of the wear extent of the artificial intervertebral disk of comparative example 1, the wear extent of the artificial intervertebral disk of embodiment 1 ~ embodiment 8 is far below the wear extent of the artificial intervertebral disk of comparative example 1, and namely the artificial intervertebral disk of embodiment 1 ~ embodiment 8 has good anti-wear performance.

Can also learn from table 1, the elastic modelling quantity of the artificial intervertebral disk of embodiment 1 ~ embodiment 8 is (21.10 ± 1.07) GPa, and the elastic modelling quantity of people's bone is 17 ~ 20GPa, elastic modelling quantity and people's bone of the artificial intervertebral disk of embodiment 1 ~ embodiment 8 are very close, namely have good biocompatibility with people's bone.And traditional elastic modelling quantity of the artificial intervertebral disk of polyether-ether-ketone that only adopts of documents 1 is (3.86 ± 0.72) Gpa, obviously, differ comparatively large with the elastic modelling quantity of people's bone, biocompatibility does not have the artificial intervertebral disk of embodiment 1 ~ embodiment 8 good.

The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.

Claims

1. an artificial intervertebral disk, is characterized in that, comprising:

Wherein, the material of described first wearing layer and the material of described second wearing layer are the mixture of polyether-ether-ketone and fortifying fibre, the material of the described first material and described 3rd reparation elementary layer repairing elementary layer includes polyether-ether-ketone and degradable first active bone repair material, the material of the described second material and described 4th reparation elementary layer repairing elementary layer is the mixture of polyether-ether-ketone and degradable second active bone repair material, described first active bone repair material is for by hydroxyapatite containing the microsphere of bone-inducing factor or described first active bone repair material, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass and the mixture formed containing the microsphere of bone-inducing factor, described second active bone repair material is selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, at least one in calcium sulfate and bioactivity glass.

2. artificial intervertebral disk according to claim 1, it is characterized in that, described first wearing layer comprises multiple the first wear-resistant elements layer stacked gradually, the material of multiple described first wear-resistant elements layer is the mixture of described polyether-ether-ketone and described fortifying fibre, from the side of described first wearing layer to opposite side, the mass percentage of the described fortifying fibre in the material of described multiple first wear-resistant elements layer reduces gradually, described second repairs elementary layer is laminated in containing on the minimum described first wear-resistant elements layer of the mass percentage of described fortifying fibre, described arc convex is formed at containing on the maximum described first wear-resistant elements layer of the mass percentage of described fortifying fibre,

Described second wearing layer comprises multiple the second wear-resistant elements layer stacked gradually, the material of multiple described second wear-resistant elements layer is the mixture of described polyether-ether-ketone and described fortifying fibre, from the side of described second wearing layer to opposite side, the mass percentage of the described fortifying fibre in the material of described multiple second wear-resistant elements layer reduces gradually, described 4th described second wear-resistant elements repairing elementary layer minimum with the mass percentage containing described fortifying fibre is folded layer by layer, described arc-shaped concave is formed at containing on the maximum described second wear-resistant elements layer of the mass percentage of described fortifying fibre.

3. artificial intervertebral disk according to claim 2, is characterized in that, in the material containing the maximum described first wear-resistant elements layer of the mass percentage of described fortifying fibre, the mass ratio of described fortifying fibre and described polyether-ether-ketone is 0.1:1 ~ 0.5:1;

4. artificial intervertebral disk according to claim 2, is characterized in that, the thickness of the described first wear-resistant elements layer that the mass percentage containing described fortifying fibre is maximum is 50 microns ~ 100 microns;

5. artificial intervertebral disk according to claim 1, it is characterized in that, described second reparation elementary layer is multiple, and multiple second reparation elementary layer stacks gradually on described first wearing layer, from the side of described first repair layer to opposite side, described multiple second mass percentage of described second active bone repair material repaired in the material of elementary layer reduces gradually, minimum described second the repairing elementary layer and be laminated on described first wearing layer of the mass percentage containing described second active bone repair material;

6. artificial intervertebral disk according to claim 1, is characterized in that, described fortifying fibre is selected from least one in carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.

7. artificial intervertebral disk according to claim 1, is characterized in that, the diameter of described fortifying fibre is 1 nanometer ~ 50 micron, and length is 10 microns ~ 1000 microns.

8. artificial intervertebral disk according to claim 1, is characterized in that, the particle diameter of described polyether-ether-ketone is less than 40 microns.

9. artificial intervertebral disk according to claim 1, is characterized in that, the particle diameter of described first active bone repair material and described second active bone repair material is 100 microns ~ 1 millimeter.

10. a preparation method for artificial intervertebral disk, is characterized in that, comprises the steps: