CN105147420B

CN105147420B - Artificial intervertebral disk and preparation method thereof

Info

Publication number: CN105147420B
Application number: CN201410243497.XA
Authority: CN
Inventors: 谭荣伟
Original assignee: SHENZHEN LANDO BIOMATERIALS CO Ltd
Current assignee: SHENZHEN LANDO BIOMATERIALS CO Ltd
Priority date: 2014-06-03
Filing date: 2014-06-03
Publication date: 2017-07-28
Anticipated expiration: 2034-06-03
Also published as: WO2015184696A1; CN105147420A

Abstract

A kind of artificial intervertebral disk, including the first soleplate and the second soleplate, the first soleplate include the first wearing layer and the first repair layer of stacking, and side of first wearing layer away from the first repair layer is formed with arc convex；Second soleplate includes the second wearing layer and the second repair layer of stacking, and side of second wearing layer away from the second repair layer is formed with arc-shaped concave, and arc convex slides against with arc-shaped concave；The material of first wearing layer includes polyether-ether-ketone and the first reinforcing fiber being mixed in polyether-ether-ketone, the material of first repair layer includes polyether-ether-ketone and the first degradable active bone repair material being mixed in polyether-ether-ketone, the material of second wearing layer includes polyether-ether-ketone and the second reinforcing fiber being mixed in polyether-ether-ketone, and the material of the second repair layer includes polyether-ether-ketone and the second degradable active bone repair material being mixed in polyether-ether-ketone.There is the longer life-span after above-mentioned artificial intervertebral disk implantation human body.In addition, also providing a kind of preparation method of artificial intervertebral disk.

Description

Artificial intervertebral disk and preparation method thereof

Technical field

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

Background technology

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

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

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

The content of the invention

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

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

A kind of artificial intervertebral disk, including：

First soleplate, includes the first wearing layer and the first repair layer of stacking, first wearing layer is away from described first The side of repair layer is formed with arc convex；And

Second soleplate, is arranged on first soleplate, and second soleplate relative can be slided with first soleplate, institute Stating the second soleplate includes the second wearing layer and the second repair layer of stacking, and second wearing layer is away from second repair layer Side is formed with arc-shaped concave, and the arc convex slides against with the arc-shaped concave；

Wherein, the first enhancing that the material of first wearing layer includes polyether-ether-ketone and is mixed in the polyether-ether-ketone Fiber, the material of first repair layer includes polyether-ether-ketone and the first degradable activity being mixed in the polyether-ether-ketone Bone renovating material, the second enhancing that the material of second wearing layer includes polyether-ether-ketone and is mixed in the polyether-ether-ketone is fine Dimension, the material of second repair layer includes polyether-ether-ketone and the second degradable active bone being mixed in the polyether-ether-ketone Repair materials, first active bone repair material and second active bone repair material be respectively selected from hydroxyapatite, α- At least one of tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass.

In one of the embodiments, first wearing layer includes multiple the first wear-resistant elements layers stacked gradually, often The material of individual first wear-resistant elements layer includes the polyether-ether-ketone and first reinforcing fiber, from the one of first wearing layer Side is to opposite side, and the weight/mass percentage composition of first reinforcing fiber in the material of the multiple first wear-resistant elements layer is gradually Reduce, first repair layer is laminated in the described first minimum wear-resisting list of the weight/mass percentage composition containing first reinforcing fiber On first layer, the arc convex is formed at the described first most wear-resisting list of the weight/mass percentage composition containing first reinforcing fiber On first layer；

Second wearing layer includes multiple the second wear-resistant elements layers stacked gradually, the material of each second wear-resistant elements layer Material includes the polyether-ether-ketone and second reinforcing fiber, and the side from second wearing layer is the multiple to opposite side The weight/mass percentage composition of second reinforcing fiber in the material of second wear-resistant elements layer is gradually decreased, second repair layer It is laminated on minimum second wear-resistant elements layer of the weight/mass percentage composition containing second reinforcing fiber, the arc-shaped concave It is formed on most second wear-resistant elements layer of the weight/mass percentage composition containing second reinforcing fiber.

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

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

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

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

In one of the embodiments, first repair layer includes multiple the first reparation elementary layers stacked gradually, often The material of individual first repair layer elementary layer includes the polyether-ether-ketone and first active bone repair material, is repaiied from described first The matter of first active bone repair material in the material of elementary layer is repaired to opposite side, the multiple first in the side of cladding Amount percentage composition is gradually decreased, and minimum first reparation of the weight/mass percentage composition containing first active bone repair material is single First layer and the described first wear-resisting layer stackup；

Second repair layer includes multiple the second reparation elementary layers stacked gradually, and each second repairs the material of elementary layer Material includes the polyether-ether-ketone and second active bone repair material, from the side of second repair layer to opposite side, institute The weight/mass percentage composition for stating second active bone repair material in the material of multiple second reparation elementary layers is gradually decreased, and is contained The weight/mass percentage composition of second the active bone repair material minimum second reparation elementary layer and second wearing layer Stacking.

In one of the embodiments, first reinforcing fiber and second reinforcing fiber be respectively selected from carbon fiber, At least one of glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber.

In one of the embodiments, the diameter of first reinforcing fiber and second reinforcing fiber is 1 nanometer ~50 microns, length is 10 microns~1000 microns.

In one of the embodiments, in the material of first wearing layer polyether-ether-ketone, the material of the first repair layer In polyether-ether-ketone, the polyether-ether-ketone in the material of the second wearing layer, the particle diameter of polyether-ether-ketone in the material of the second repair layer Respectively less than 40 microns.

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

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

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

The first degradable active bone repair material is mixed with polyether-ether-ketone, the first mixing material is obtained, wherein, it is described First active bone repair material is in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass At least one；

There is provided the first mould, first mould has the lower arcuate surface of evagination, by first mixed material with it is described First mixing material is sequentially added in first mould, after shaping, removes first mould, obtains including the of stacking First sample blanks of one wearing layer base substrate and the first repair layer base substrate, the first wearing layer base substrate is away from the first repair layer base The side of body is formed with arc convex；

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

The second degradable active bone repair material is mixed with polyether-ether-ketone, the second mixing material is obtained, wherein, it is described Second active bone repair material is in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass At least one；

There is provided the second mould, second mould has the lower arcuate surface of indent, by second mixed material with it is described Second mixing material is sequentially added in second mould, after shaping, removes second mould, obtains including the of stacking Second sample blanks of two wearing layer base substrates and the second repair layer base substrate, the second wearing layer base substrate is away from the second repair layer base The side of body is formed with arc-shaped concave；And

First sample blanks and second sample blanks are sintered respectively, the first soleplate and the second soleplate is obtained.

After above-mentioned artificial intervertebral disk is implanted into human body, pass through the arc convex and the arc-shaped concave of the second soleplate of the first soleplate Slide against, to realize the relative slip of the first soleplate and the second soleplate, and the first soleplate of above-mentioned artificial intervertebral disk includes layer Folded the first wearing layer and the first repair layer, and the second soleplate includes the second wearing layer and the second repair layer of stacking, and first The material of wearing layer includes polyether-ether-ketone and the first reinforcing fiber, and the material of the second wearing layer includes polyether-ether-ketone and the second enhancing Fiber, and arc convex is located on the first wearing layer, arc-shaped concave is located on the second wearing layer so that arc convex is recessed with arc Face is respectively provided with preferable anti-wear performance, and abrasion loss amount is about 0.05~0.4mg/MC (MC represents million circulations), that is, is worn and torn Rate is simple using the 2%~14.5% of the artificial intervertebral disk that polyether-ether-ketone is material, well below Traditional Man interverbebral disc Wear rate, because arc convex and the arc-shaped concave of above-mentioned artificial intervertebral disk are respectively provided with preferable anti-wear performance, so that effectively The generation of abrasive dust is reduced, the life-span of artificial intervertebral disk is added；In addition, the material of the first repair layer includes polyether-ether-ketone and can First active bone repair material of degraded, the material of the second repair layer includes polyether-ether-ketone and the degradable second active Bone Defect Repari Material, after above-mentioned artificial intervertebral disk is implanted, degradable the first active bone repair material and the second active bone repair material It can be degraded, so that the first repair layer and the second repair layer become a loose structure, now, freshman bone tissue can Grow into loose structure so that bone tissue can be closely combined together with the first repair layer and the second repair layer respectively, increase Add the first soleplate and the second soleplate in the long-time stability implanted, that is, ensure that artificial intervertebral disk after implantation human body Long-time stability, therefore, have the longer life-span after above-mentioned artificial intervertebral disk implantation human body.

Brief description of the drawings

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

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

Embodiment

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

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

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

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

Wherein, the material of the first wearing layer 112 includes polyether-ether-ketone and the first reinforcing fiber being mixed in polyether-ether-ketone. The first reinforcing fiber is mixed in polyether-ether-ketone so that the first wearing layer 112 has preferable crocking resistance.

Wherein, the polyether-ether-ketone in the material of the first wearing layer 112 is implantation level.It is preferred that, the particle diameter of polyether-ether-ketone is small In 40 microns.The polyether-ether-ketone of small particle is easy to be well mixed with the first reinforcing fiber, and advantageously reduces defect, so as to increase The mechanical property of strong first wearing layer 112.

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

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

It is preferred that, a diameter of 1 nanometer~50 microns of the first reinforcing fiber, length is 10 microns~1000 microns.The chi The first very little reinforcing fiber can not only be well mixed with above-mentioned polyether-ether-ketone, so as to improve the stress of the first wearing layer 112 Continuity and uniformity, additionally it is possible to the enhanced effect of nanometer is played, so as to improve the anti-wear performance of the first wearing layer 112.

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

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

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

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

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

It is preferred that, the first wear-resistant elements layer 1124 is 3~10.3~10 the first wear-resistant elements layers 1124 are not only Gradient-structure is met, the effect of transition is served, the number of plies of the first wear-resistant elements layer 1124 excessively adds preparation work on the contrary Skill.In the diagram of present embodiment, the first wear-resistant elements layer 1124 is 3.It is appreciated that in other embodiments, the One wear-resistant elements layer 1124 can also be 1,2 either more than 10.

Wherein, the first repair layer 114 is laminated in the first minimum wear-resisting list of the weight/mass percentage composition containing the first reinforcing fiber On first layer 1124.

The material of first repair layer 114 includes polyether-ether-ketone and the first degradable active bone being mixed in polyether-ether-ketone Repair materials.

After the implantation human body of artificial intervertebral disk 100, the first degradable active bone repair material in the first repair layer 114 Can progressively it be degraded, so that the first repair layer 114 becomes a loose structure, freshman bone tissue can grow into the porous knot In structure, so that bone tissue is closely combined together with the first repair layer 114, it is ensured that after artificial intervertebral disk 100 implants, the One soleplate 110 has long-time stability.

Wherein, the polyether-ether-ketone of the material of the first repair layer 114 is implantation level.It is preferred that, the particle diameter of polyether-ether-ketone is less than 40 microns.

Wherein, the first active bone repair material be selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and At least one of bioactivity glass.These materials can not only degrade, additionally it is possible to promote new Bone Ingrowth.

It is preferred that, the particle diameter of the first active bone repair material is 100 microns~1 millimeter.Due to the first active Bone Defect Repari material Material is eventually degraded, and the first repair layer 114 formation loose structure, the first active bone repair material of the particle size range is conducive to carefully Born of the same parents and tissue are grown into loose structure.

It is preferred that, the first repair layer 114 includes multiple the first reparation elementary layers 1144 stacked gradually, and each first repairs The material of elementary layer 1144 includes polyether-ether-ketone and the first active bone repair material.From the side of the first repair layer 114 to another The weight/mass percentage composition of the first active bone repair material in side, the material of multiple first reparation elementary layers 1144 is gradually decreased. By the first repair layer 114 be set to it is multiple contain that the first active bone repair material gradually decreases second repair elementary layer 1144, be In order that structure is in a transition stage, area of new bone is set constantly to grow into, full of in the hole left after degraded, because the first activity Bone renovating material is can be degraded to absorb by tissue, before gradually the new Bone Ingrowth of tissue generation is absorbed in degradation process The first active bone repair material position, now, non-degradable component still functions as the effect of a mechanical support, without leading Cause in degradation process because degradable component and the layering of non-degradable component substantially destroy the structure of artificial intervertebral disk.

Wherein, the first reparation elementary layer 1144 and first of weight/mass percentage composition at least containing the first active bone repair material Wearing layer 112 is laminated.Specifically, the first minimum reparation elementary layer of the weight/mass percentage composition containing the first active bone repair material The 1144 first wear-resistant elements layers 1124 minimum with the weight/mass percentage composition containing the first reinforcing fiber are laminated.

It is preferred that, each first repairs in the material of elementary layer 1144, the first active bone repair material and polyether-ether-ketone Mass ratio is 0.005~1:1.First active bone repair material of the proportion can be repaired with polyether-ether-ketone ensureing first The still uniform stressed during degraded of elementary layer 1144.

It is furthermore preferred that first repairs elementary layer 1144 for 3~5.In the diagram of present embodiment, first repairs single First layer 1144 is 3.It is appreciated that in other embodiments, first repair elementary layer 1144 can also for 1,2 or It is greater than 5.

In the present embodiment, it is formed with fixed lobe 1146 on the first repair layer 114, and fixed lobe 1146 is located at the Side of one repair layer 114 away from the first wearing layer 112, the fixed lobe 1146 can strengthen equivalent to the effect of nail Stability of one soleplate 110 in human body.Specifically, fixed lobe 1146 is arranged at the quality containing the first active bone repair material On the first most reparation elementary layer 1144 of percentage composition.

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

Side of second wearing layer 122 away from the second repair layer 124 is formed with arc-shaped concave 1222, wherein, arc convex 1122 slide against with arc-shaped concave 1222, so as to realize the relative slip between the first soleplate 110 and the second soleplate 120.Tool Body, the curvature of arc-shaped concave 1222 is equal with the curvature of arc convex 1122.The curvature and arc convex of arc-shaped concave 1222 1122 curvature is consistent, is conducive to the motion between the first soleplate 110 and the second soleplate 120.

Wherein, the material of the second wearing layer 122 includes polyether-ether-ketone and the second reinforcing fiber being mixed in polyether-ether-ketone. The second reinforcing fiber is mixed in polyether-ether-ketone so that the second wearing layer 122 has preferable crocking resistance.

Wherein, the polyether-ether-ketone in the material of the second wearing layer 122 is implantation level.It is micro- that the particle diameter of polyether-ether-ketone is less than 40 Rice.

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

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

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

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

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

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

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

Wherein, the second repair layer 124 is laminated in the second minimum wear-resisting list of the weight/mass percentage composition containing the second reinforcing fiber On first layer 1224.

The material of second repair layer 124 includes polyether-ether-ketone and the second degradable active bone being mixed in polyether-ether-ketone Repair materials.

After artificial intervertebral disk 100 is being implanted into human body, the active Bone Defect Repari material of degradable second in the second repair layer 124 Material can progressively be degraded, so that the second repair layer 124 becomes a loose structure, it is porous that freshman bone tissue can grow into this In structure, so that bone tissue is closely combined together with the second repair layer 124, it is further ensured that artificial intervertebral disk 100 is implanted into After human body, the second soleplate 120 has long-time stability.

Wherein, the polyether-ether-ketone of the material of the second repair layer 124 is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

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

It is preferred that, the particle diameter of the second active bone repair material is 100 microns~200 microns.

It is preferred that, the second repair layer 124 includes multiple the second reparation elementary layers 1244 stacked gradually, and each second repairs The material of elementary layer 1244 includes polyether-ether-ketone and the second active bone repair material.From the side of the second repair layer 124 to another The weight/mass percentage composition of the second active bone repair material in side, the material of multiple second reparation elementary layers 1244 is gradually decreased. Second repair layer 124 is set to multiple the second reparation elementary layers 1244 stacked gradually, and makes the second active bone repair material Gradually decrease, be in order that the second repair layer 124 is in transition stage, area of new bone is constantly grown into, full of being stayed after degraded Under hole in absorbed because the second active bone repair material can be degraded by tissue, the gradually human body in degradation process Tissue generates the position of the second active bone repair material before new Bone Ingrowth is absorbed, and now, non-degradable component still functions as one The effect of individual mechanical support, without causing in degradation process because degradable component and the layering of non-degradable component substantially destroy people The structure of work interverbebral disc.

Wherein, the second reparation elementary layer 1244 and second of weight/mass percentage composition at least containing the second active bone repair material Wearing layer 122 is laminated.Specifically, the second minimum reparation elementary layer of the weight/mass percentage composition containing the second active bone repair material The 1244 second wear-resistant elements layers 1224 minimum with the weight/mass percentage composition containing the second reinforcing fiber are laminated.

Wherein, in each second material for repairing elementary layer 1244, the second active bone repair material and polyether-ether-ketone Mass ratio is 0.005~1:1.Before the proportion can have certain hole after the degraded of the second active bone repair material is ensured Put, remain to uniform stressed.

It is furthermore preferred that second repairs elementary layer 1244 for 3~5.In the diagram of present embodiment, second repairs single First layer 1244 is 3.It is appreciated that in other embodiments, second repair elementary layer 1244 can also for 1,2 or It is greater than 5.

In the present embodiment, it is formed with connection bump 1246 on the second repair layer 124, and connection bump 1246 is located at the One side of two repair layers 124 away from the second wearing layer 122, the connection bump 1246 can strengthen equivalent to the effect of nail Stability of two soleplates 120 in human body.Specifically, connection bump 1246 be located at containing the second active bone repair material it is most the Two repair on elementary layer 1244.

After above-mentioned artificial intervertebral disk 100 is implanted into human body, pass through the soleplate of arc convex 1122 and second of the first soleplate 110 120 arc-shaped concave 1222 slides against, to realize the relative slip of the first soleplate 110 and the second soleplate 120, and above-mentioned artificial First soleplate 110 of interverbebral disc 100 includes the first wearing layer 112 and the first repair layer 114 of stacking, and the second soleplate 120 is wrapped The second wearing layer 122 and the second repair layer 124 of stacking are included, and the material of the first wearing layer 112 includes polyether-ether-ketone and first Reinforcing fiber, the material of the second wearing layer 122 includes polyether-ether-ketone and the second reinforcing fiber, and arc convex 1122 is located at first On wearing layer 112, arc-shaped concave 1222 is located on the second wearing layer 122 so that arc convex 1122 and arc-shaped concave 1222 are equal With preferable anti-wear performance, abrasion loss amount is about 0.05~0.4mg/MC (MC represents million circulations), i.e., wear rate is Simple is the 2%~14.5% of the artificial intervertebral disk of material using polyether-ether-ketone, well below the abrasion of Traditional Man interverbebral disc Rate, because arc convex 1122 and the arc-shaped concave 1222 of above-mentioned artificial intervertebral disk 100 are respectively provided with preferable anti-wear performance, so that The generation of abrasive dust is effectively reduced, the life-span of above-mentioned artificial intervertebral disk 100 is added；In addition, the material of the first repair layer 114 Including polyether-ether-ketone and the first degradable active bone repair material, the material of the second repair layer 124 includes polyether-ether-ketone and can Second active bone repair material of degraded, after above-mentioned artificial intervertebral disk 100 is implanted, the first degradable active Bone Defect Repari material Material and the second active bone repair material can be degraded, so that the first repair layer 114 and the second repair layer 124 become one Porous structure, now, freshman bone tissue can be grown into loose structure so that bone tissue can respectively with the first repair layer 114 and second repair layer 124 be closely combined together, add the first soleplate 110 and the second soleplate 120 and implanting Long-time stability, that is, ensure that long-time stability of the artificial intervertebral disk 100 after implantation human body, therefore, above-mentioned artificial intervertebral disk There is the longer life-span after 100 implantation human bodies.

As shown in Fig. 2 the preparation method of the artificial intervertebral disk of an embodiment, when without using the microballoon containing bone-inducing factor During as active bone repair material, above-mentioned artificial intervertebral disk can use the preparation method of the artificial intervertebral disk of the embodiment Prepare.The preparation method of the artificial intervertebral disk comprises the following steps：

Step S210：First reinforcing fiber is mixed with polyether-ether-ketone, the first mixed material is obtained.

In step S210, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

Wherein, the first reinforcing fiber be selected from carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and At least one of titanium-base crystal whisker fiber.

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

It is preferred that, in step S210, the step of the first reinforcing fiber is mixed with polyether-ether-ketone is specially：By the first enhancing Fiber is mixed according to multiple different mass ratioes respectively from polyether-ether-ketone, obtains multiple first mixed materials.

In the particular embodiment, by the first reinforcing fiber from polyether-ether-ketone respectively according to 3~10 different quality Than mixing, 3~10 the first mixed materials are obtained.

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

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

Step S220：The first degradable active bone repair material is mixed with polyether-ether-ketone, the first mixing material is obtained.

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

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

In step S220, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

It is preferred that, in step S220, the step of the first degradable active bone repair material is mixed with polyether-ether-ketone has Body is：The first degradable active bone repair material is mixed according to multiple different mass ratioes respectively from polyether-ether-ketone, obtained Multiple first mixing materials.

In the particular embodiment, by the first degradable active bone repair material and polyether-ether-ketone respectively according to 3~5 Individual different mass ratio mixing, obtains 3~5 the first mixing materials.

Wherein, the mass ratio of the first active bone repair material of each first mixing material and polyether-ether-ketone be 0.005~ 1:1。

Step S230：The first mould is provided, the first mould has the lower arcuate surface of evagination, by the first mixed material and first Mixing material is sequentially added in the first mould, after shaping, is removed the first mould, is obtained including the first wearing layer base substrate of stacking With the first sample blanks of the first repair layer base substrate, it is convex that side of the first wearing layer base substrate away from the first repair layer base substrate is formed with arc Face.

When the first mixed material and the first mixing material are multiple, in step S230, by the first mixed material and The step that one mixing material is sequentially added in the first mould is specially：The first weight/mass percentage composition according to the first reinforcing fiber is gradually Multiple first mixed materials, are added in the first mould by the order of reduction successively, then according still further to the first active Bone Defect Repari material Multiple first mixing materials, are added in the first mould by the weight/mass percentage composition of material gradually increased order successively.Wherein, contain The first most mixed material of the weight/mass percentage composition of first reinforcing fiber is added to the bottom of the first mould.

Specifically, the forming method used in step S230 is cold moudling；Wherein, forming method is specially：In cold conditions Under, there are the first mixed material and the first mould pressurizing of the first mixing material to 110MPa~250MPa, 10 points of pressurize by adding Clock~20 minute.

After step S230, the first sample blanks can also be placed under repair as needed.For example, the burr in the first sample blanks Deng, can pass through repair remove.

Step S240：Second reinforcing fiber is mixed with polyether-ether-ketone, the second mixed material is obtained.

In step S240, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

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

It is preferred that, in step S240, the step of the second reinforcing fiber is mixed with polyether-ether-ketone is specially：By the second enhancing Fiber is mixed according to multiple different mass ratioes respectively from polyether-ether-ketone, obtains multiple second mixed materials.Specifically implementing In example, the second reinforcing fiber is mixed according to 3~10 different mass ratioes respectively from polyether-ether-ketone, 3~10 are obtained Second mixed material.

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

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

Step S250：The second degradable active bone repair material is mixed with polyether-ether-ketone, the second mixing material is obtained.

In step S250, polyether-ether-ketone is implantation level.The particle diameter of polyether-ether-ketone is less than 40 microns.

Wherein, the second active bone repair material be selected from hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and At least one of bioactivity glass.It is preferred that, the particle diameter of the second active bone repair material is 100 microns~1 millimeter.

It is preferred that, in step S250, the step of the second degradable active bone repair material is mixed with polyether-ether-ketone has Body is：The second degradable active bone repair material is mixed according to multiple different mass ratioes respectively from polyether-ether-ketone, obtained Multiple second mixing materials.

In the particular embodiment, by the second degradable active bone repair material and polyether-ether-ketone respectively according to 3~5 Individual different mass ratio mixing, obtains 3~5 the second mixing materials.

It is preferred that, the mass ratio of the second active bone repair material and polyether-ether-ketone is 0.005 in each second mixing material ~1:1.

Step S260：The second mould is provided, the second mould has the lower arcuate surface of indent, by the second mixed material and second Mixing material is sequentially added in the second mould, after shaping, is removed the second mould, is obtained including the second wearing layer base substrate of stacking With the second sample blanks of the second repair layer base substrate, it is recessed that side of the second wearing layer base substrate away from the second repair layer base substrate is formed with arc Face.

When the second mixed material and the second mixing material are multiple, in step S260, by the second mixed material and The step that two mixing materials are sequentially added in the second mould is specially：The first weight/mass percentage composition according to the second reinforcing fiber is gradually Multiple second mixed materials, are added in the second mould by the order of reduction successively, then according still further to the second active Bone Defect Repari material Multiple second mixing materials, are added in the second mould by the weight/mass percentage composition of material gradually increased order successively.Wherein, The second most mixed material of the weight/mass percentage composition of two reinforcing fibers is added to the bottom of the second mould.

Specifically, the forming method used in step S260 is cold moudling；Wherein, forming method is specially：In cold conditions Under, there are the second mixed material and the second mould pressurizing of the second mixing material to 110MPa~250MPa, 10 points of pressurize by adding Clock~20 minute.

After step S260, the second sample blanks can also be placed under repair as needed.

Step S270：The first sample blanks and the second sample blanks are sintered respectively, the first soleplate and the second soleplate is obtained.Produce To artificial intervertebral disk.

Specifically, the sintering step in step S270 is specially：By the first sample blanks and the second sample blanks prior to 355 DEG C~400 DEG C heat preservation sintering 20 minutes~30 minutes, then then at 220 DEG C~280 DEG C heat preservation sinterings 1 hour~2 hours.By the first sample blanks With the second sample blanks first in 355 DEG C~400 DEG C heat preservation sinterings, then again in 220 DEG C~280 DEG C heat preservation sinterings, be in order to avoid burn The Growing Process of Crystal Particles in later stage is tied, by the way that sintering temperature first to be risen to higher temperature, in molten condition, bubble is removed, makes The relative density of sample blanks reaches 70% or so；Then, sintering temperature is dropped to insulation longer time at relatively low temperature makes burning Knot proceeds, and realizes complete densification.This stage crystal grain does not substantially grow.Two-step sintering method is by cleverly The change of temperature is controlled, while crystal boundary migration (this will cause crystal grain to be grown up) is suppressed, keeping grain boundary decision, (this is that base substrate is caused The power of densification) active state is in, to realize the purpose that sintering is completed on the premise of crystal grain is not grown up.

After step S270, in addition to local repair, cleaning are carried out to the first soleplate and the second soleplate respectively, dry and The step of sterilizing.

It is appreciated that in specific operating process, being not limited only to prepare using said sequence, it can also use other Sequentially, for example, step S210 and step S220 can be with reversed orders；Or, step S240~S260 can be first carried out, then carry out Step S210~S230 etc..

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

It is embodiment part below：

Embodiment 1

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

(1) respectively according to mass ratio be 0.1:1、0.08:1 and 0.06:1, by the polyether-ether-ketone of reinforcing fiber and implantation level Mixing, obtains the first mixed material 1, the first mixed material 2 and the first mixed material 3, wherein, reinforcing fiber is carbon fiber, directly Footpath is 50 microns, and length is 10 microns；The particle diameter of polyether-ether-ketone is 30 microns.

(2) respectively according to mass ratio be 0.1:1、0.4:1、0.7:1 and 1:1, by active bone repair material and implantation level Polyether-ether-ketone is mixed, and obtains the first mixing material 1, the first mixing material 2, the first mixing material 3 and the first mixing material 4, its In, active bone repair material is hydroxyapatite, and particle diameter is 100 microns, and the particle diameter of polyether-ether-ketone is 30 microns.

(3) the first mould is provided, the first mould has the lower arcuate surface of evagination, is mixed according to the first mixed material 1, first Material 2, the first mixed material 3, the first mixing material 1, the first mixing material 2, the first mixing material 3 and the first mixing material 4 Order above-mentioned material is added in the first mould, wherein, the first mixed material 1 is added to the bottom of the first mould, material After addition is finished, cold moudling is carried out to the first mould pressurizing to 110MPa, pressurize 10 minutes removes the first mould, wrapped First sample blanks of the first wearing layer base substrate and the first repair layer base substrate containing stacking, wherein, the first wearing layer base substrate is away from The side of one repair layer base substrate is formed with arc convex, and the first wearing layer base substrate has three the first wear-resisting lists stacked gradually First layer base substrate, the first repair layer base substrate has four the first reparation elementary layer base substrates stacked gradually.Finally can be right as needed First sample blanks places under repair.

(4) respectively according to mass ratio be 0.1:1、0.08:1 and 0.06:1, by the polyether-ether-ketone of reinforcing fiber and implantation level Mixing, obtains the second mixed material 1, the second mixed material 2 and the second mixed material 3, wherein, reinforcing fiber is carbon fiber, directly Footpath is 50 microns, and length is 10 microns；The particle diameter of polyether-ether-ketone is 30 microns.

(5) respectively according to mass ratio be 0.1:1、0.3:1、0.4:1 and 0.5:1, by active bone repair material and implantation level Polyether-ether-ketone mixing, obtain the second mixing material 1, the second mixing material 2, the second mixing material 3 and the second mixing material 4, Wherein, active bone repair material is hydroxyapatite, and particle diameter is 100 microns；The particle diameter of polyether-ether-ketone is 30 microns.

(6) the second mould is provided, the second mould has the lower arcuate surface of indent, is mixed according to the second mixed material 1, second Material 2, the second mixed material 3, the second mixing material 1, the second mixing material 2, the second mixing material 3 and the second mixing material 4 Order above-mentioned material is added in the second mould, wherein, the second mixed material 1 is added to the bottom of the second mould, material After addition is finished, then the second mould pressurizing carries out cold moudling to 110MPa, and pressurize 10 minutes removes the second mould, obtained Include the second wearing layer base substrate of stacking and the second sample blanks of the second repair layer base substrate.Wherein, the second wearing layer base substrate is remote The side of second repair layer base substrate is formed with arc-shaped concave, and the second wearing layer has three the second wear-resistant elements stacked gradually layers Base substrate, the second repair layer has four the second reparation elementary layers stacked gradually.Finally the second sample blanks can be carried out as needed Repair.

(7) by the first sample blanks and prior to 355 DEG C of the second sample blanks heat preservation sintering 25 minutes, then then at 220 DEG C of heat preservation sinterings 2 Hour, the first soleplate and the second soleplate are obtained, that is, obtains the artificial intervertebral disk of the present embodiment.Wherein, it is formed with arc convex The thickness of first wear-resistant elements layer is 50 microns, and the thickness for being formed with the second wear-resistant elements layer of arc-shaped concave is 50 microns.

Then local repair, cleaning, drying, packaging are carried out to the first soleplate and the second soleplate respectively and sterilized.

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

Modulus of elasticity test is carried out to the artificial intervertebral disk of the present embodiment according to ISO527 method, the present embodiment it is artificial The modulus of elasticity of interverbebral disc is shown in Table 1.

Embodiment 2

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

(2) respectively according to mass ratio be 0.1:1、0.2:1、0.3:1、0.4:1 and 0.5:1, by active bone repair material with The polyether-ether-ketone mixing of level is implanted into, the first mixing material 1, the first mixing material 2, the first mixing material 3, the first mixing material is obtained The mixing material 5 of material 4 and first, wherein, active bone repair material is bata-tricalcium phosphate, and particle diameter is 200 microns, the grain of polyether-ether-ketone Footpath is 10 microns.

(3) the first mould is provided, the first mould has the lower arcuate surface of evagination, is mixed according to the first mixed material 1, first Material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6, the first mixed material 7, First mixed material 8, the first mixed material 9, the first mixed material 10, the first mixing material 1, the first mixing material 2, first are mixed Above-mentioned material is added in the first mould by the order of condensation material 3, the first mixing material 4 and the first mixing material 5, wherein, the One mixed material 1 is added to the bottom of the first mould, and after material addition is finished, the first mould pressurizing to 110MPa is cold-pressed Shaping, pressurize 20 minutes removes the first mould, obtains including the first wearing layer base substrate and the first repair layer base substrate of stacking First sample blanks, wherein, side of the first wearing layer base substrate away from the first repair layer base substrate is formed with arc convex, the first wearing layer Base substrate have ten stack gradually the first wear-resistant elements layer base substrate, the first repair layer base substrate have five stack gradually first Repair elementary layer base substrate.Finally, the first sample blanks is placed under repair as needed.

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

(5) respectively according to mass ratio be 0.1:1、0.2:1、0.3:1、0.4:1 and 0.5:1, by active bone repair material with The polyether-ether-ketone mixing of level is implanted into, the second mixing material 1, the second mixing material 2, the second mixing material 3, the second mixture is obtained The mixed material 5 of material 4 and second, wherein, active bone repair material is bata-tricalcium phosphate, and particle diameter is 200 microns, the grain of polyether-ether-ketone Footpath is 10 microns.

(6) the second mould is provided, the second mould has the lower arcuate surface of indent, is mixed according to the second mixed material 1, second Material 2, the second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the second mixed material 7, Second mixed material 8, the second mixed material 9, the second mixed material 10, the second mixing material 1, the second mixing material 2, second are mixed Above-mentioned material is added in the second mould by the order of condensation material 3, the second mixing material 4 and the second mixing material 5, wherein, the Two mixed materials 1 are added to the bottom of the second mould, and after material addition is finished, then the first mould pressurizing to 110MPa is carried out Cold moudling, pressurize 20 minutes removes the second mould, obtains including the second wearing layer base substrate of stacking and the second repair layer base substrate The second sample blanks, wherein, side of the second wearing layer base substrate away from the second repair layer base substrate is formed with arc-shaped concave, and second is wear-resisting Layer base substrate has ten the second wear-resistant elements stacked gradually layer base substrates, and the second repair layer is repaiied with five stack gradually second Multiple elementary layer.Finally, the second sample blanks can be placed under repair as needed.

(7) by the first sample blanks and prior to 400 DEG C of the second sample blanks heat preservation sintering 20 minutes, then then at 280 DEG C of heat preservation sinterings 1 Hour, the first soleplate and the second soleplate are obtained, that is, obtains the artificial intervertebral disk of the present embodiment.Wherein, it is formed with arc convex The thickness of first wear-resistant elements layer is 100 microns, and the thickness for being formed with the second wear-resistant elements layer of arc-shaped concave is 100 microns.

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

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

Embodiment 3

(1) respectively according to mass ratio be 0.1:1、0.09:1、0.08:1、0.07:1、0.06:1 and 0.05:1, enhancing is fine Tie up and mixed with being implanted into the polyether-ether-ketone of level, obtain the first mixed material 1, the first mixed material 2, the first mixed material 3, first and mix Compound material 4, the first mixed material 5 and the first mixed material 6, wherein, reinforcing fiber is carbon fiber, silicon carbide fibre, stainless steel Four kinds of fiber and titanium-base crystal whisker fiber, a diameter of 100 nanometers of reinforcing fiber, length is 100 microns；The particle diameter of polyether-ether-ketone is 20 microns.

(2) respectively according to mass ratio be 0.1:1、0.3:1 and 0.5:1, by active bone repair material and the polyethers of implantation level Ether ketone is mixed, and obtains the first mixing material 1, the first mixing material 2 and the first mixing material 3, wherein, active bone repair material is Type alpha tricalcium phosphate, calcium sulfate and bioactivity glass, the particle diameter of active bone repair material is 150 microns, the particle diameter of polyether-ether-ketone For 20 microns.

(3) the first mould is provided, the first mould has the lower arcuate surface of evagination, is mixed according to the first mixed material 1, first Material 2, the first mixed material 3, the first mixed material 4, the first mixed material 5, the first mixed material 6, the first mixing material 1, Above-mentioned material is added in the first mould by the order of the first mixing material 2 and the first mixing material 3, wherein, the first mixture Material 1 is added to the bottom of the first mould, then carries out cold moudling to the first mould pressurizing to 200MPa, and pressurize 15 minutes is gone Except the first mould, obtain including the first wearing layer base substrate of stacking and the first sample blanks of the first repair layer base substrate, wherein, first Side of the wearing layer base substrate away from the first repair layer base substrate is formed with arc convex, and the first wearing layer base substrate has six layers successively Folded the first wear-resistant elements layer base substrate, the first repair layer base substrate has three the first reparation elementary layer base substrates stacked gradually.Most After the first sample blanks can be placed under repair as needed.

(4) respectively according to mass ratio be 0.1:1、0.09:1、0.08:1、0.07:1、0.06:1 and 0.05:1, enhancing is fine Tie up and mixed with being implanted into the polyether-ether-ketone of level, obtain the second mixed material 1, the second mixed material 2, the second mixed material 3, second and mix Compound material 4, the second mixed material 5 and the second mixed material 6, reinforcing fiber be carbon fiber, silicon carbide fibre, stainless steel fibre and Four kinds of titanium-base crystal whisker fiber, a diameter of 100 nanometers of reinforcing fiber, length is 100 microns, and the particle diameter of polyether-ether-ketone is micro- for 20 Rice.

(5) respectively according to mass ratio be 0.1:1、0.3:1 and 0.5:1, by active bone repair material and the polyethers of implantation level Ether ketone is mixed, and obtains the second mixing material 1, the second mixing material 2 and the second mixing material 3, wherein, active bone repair material is Two kinds of type alpha tricalcium phosphate, calcium sulfate and bioactivity glass, the particle diameter of active bone repair material is 150 microns, polyether-ether-ketone Particle diameter is 20 microns.

(6) the second mould is provided, the second mould has the lower arcuate surface of evagination, mixed according to by the second mixed material 1, second Compound material 2, the second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the second mixing material 1st, above-mentioned material is added in the second mould by the order of the second mixing material 2 and the second mixing material 3, wherein, the second mixing Material 1 is added to the bottom of the second mould, then to the second mould pressurizing to 200MPa progress cold moudlings, pressurize 15 minutes, The second mould is removed, obtains including the second wearing layer base substrate of stacking and the second sample blanks of the second repair layer base substrate, wherein, the Side of the two wearing layer base substrates away from the second repair layer base substrate is formed with arc-shaped concave, and the second wear-resistant elements layer base substrate has six The the second wear-resistant elements layer base substrate stacked gradually, the second repair layer has three the second reparation elementary layers stacked gradually.Finally The second sample blanks can be placed under repair as needed.

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

Embodiment 4

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

(2) it is 0.005 according to mass ratio:1, active bone repair material is mixed with being implanted into the polyether-ether-ketone of level, the is obtained One mixing material, wherein, active bone repair material is hydroxyapatite, and particle diameter is 100 microns, and the particle diameter of polyether-ether-ketone is micro- for 30 Rice.

(3) the first mould is provided, the first mould has the lower arcuate surface of evagination, successively mixes the first mixed material and first Condensation material is added in the first mould, wherein, the first mixed material is added to the bottom of the first mould, and then the first mould is added It is depressed into 110MPa and carries out cold moudling, pressurize 10 minutes removes the first mould, obtains including the first wearing layer base substrate of stacking With the first sample blanks of the first repair layer base substrate, the first sample blanks is placed under repair as needed.And first wearing layer base substrate away from The side of one repair layer base substrate is formed with arc convex.

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

(5) it is 0.005 according to mass ratio:1, active bone repair material is mixed with being implanted into the polyether-ether-ketone of level, the is obtained Two mixing materials, wherein, active bone repair material is hydroxyapatite, and particle diameter is 100 microns, and the particle diameter of polyether-ether-ketone is micro- for 30 Rice.

(6) the second mould is provided, the second mould has the lower arcuate surface of indent, successively mixes the second mixed material and second Condensation material is added in the second mould, wherein, the second mixed material is added to the bottom of the second mould, and then the second mould is added It is depressed into 110MPa and carries out cold moudling, pressurize 10 minutes removes the second mould, obtains including the second wearing layer base substrate of stacking With the second sample blanks of the second repair layer base substrate, the second sample blanks is placed under repair as needed.And second wearing layer base substrate away from The side of two repair layer base substrates is formed with arc-shaped concave.

(7) by the first sample blanks and prior to 355 DEG C of the second sample blanks heat preservation sintering 25 minutes, then then at 220 DEG C of heat preservation sinterings 2 Hour, the first soleplate and the second soleplate are obtained, the first wearing layer and the second wearing layer thickness are 50 microns, obtain the present embodiment Artificial intervertebral disk.

Embodiment 5

(1) respectively according to mass ratio be 0.5:1、0.4:1、0.3:1 and 0.1:1, by the polyethers of reinforcing fiber and implantation level Ether ketone is mixed, and obtains the first mixed material 1, the first mixed material 2, the first mixed material 3 and the first mixed material 4, wherein, increase Strong fiber is three kinds of graphite fibre, glass fibre and titanium-base crystal whisker fiber, and a diameter of 25 microns of reinforcing fiber, length is 500 Micron, the particle diameter of polyether-ether-ketone is 25 microns.

(2) respectively according to mass ratio be 0.1:1、0.2:1、0.3:1 and 0.4:1, by active bone repair material and implantation level Polyether-ether-ketone mixing, obtain the first mixing material 1, the first mixing material 2, the first mixing material 3 and the first mixing material 4, Wherein, active bone repair material is two kinds of type alpha tricalcium phosphate and bioactivity glass, and the particle diameter of active bone repair material is 1 milli Rice, the particle diameter of polyether-ether-ketone is 25 microns.

(3) the first mould is provided, the first mould has the lower arcuate surface of evagination, is mixed according to the first mixed material 1, first Material 2, the first mixed material 3, the first mixed material 4, the first mixing material 1, the first mixing material 2, the first mixing material 3 and Above-mentioned material is added in the first mould by the order of the first mixing material 4, wherein, the first mixed material 1 is added to the first mould The bottom of tool, then carries out cold moudling to the first mould pressurizing to 160MPa, and pressurize 16 minutes removes the first mould, obtained Include stacking the first wearing layer base substrate and the first repair layer base substrate the first sample blanks wherein, the first wearing layer base substrate is away from The side of one repair layer base substrate is formed with arc convex, and the first wear-resistant elements layer base substrate have four stack gradually it is first resistance to Elementary layer base substrate is ground, the first repair layer base substrate has four the first reparation elementary layer base substrates stacked gradually.As needed to the One sample blanks places under repair.

(4) respectively according to mass ratio be 0.5:1、0.4:1、0.3:1 and 0.1:1, by the polyethers of reinforcing fiber and implantation level Ether ketone is mixed, and obtains the second mixed material 1, the second mixed material 2, the second mixed material 3 and the second mixed material material 4, is strengthened Fiber is three kinds of graphite fibre, glass fibre and titanium-base crystal whisker fiber, and a diameter of 25 microns of reinforcing fiber, length is 500 micro- Rice, the particle diameter of polyether-ether-ketone is 25 microns.

(5) respectively according to mass ratio be 0.1:1、0.3:1 and 0.5:1, by active bone repair material and the polyethers of implantation level Ether ketone is mixed, and obtains the second mixing material 1, the second mixing material 2 and the second mixing material 3, wherein, active bone repair material is Two kinds of type alpha tricalcium phosphate and bioactivity glass, the particle diameter of active bone repair material is 150 microns, and the particle diameter of polyether-ether-ketone is 20 Micron.

(6) the second mould is provided, the second mould has the lower arcuate surface of evagination, mixed according to by the second mixed material 1, second Compound material 2, the second mixed material 3, the second mixed material 4, the second mixed material 5, the second mixed material 6, the second mixing material 1st, above-mentioned material is added in the second mould by the order of the second mixing material 2 and the second mixing material 3, wherein, the second mixing Material 1 is added to the bottom of the second mould, then to the second mould pressurizing to 160MPa progress cold moudlings, pressurize 16 minutes, The second mould is removed, obtains including the second wearing layer base substrate of stacking and the second sample blanks of the second repair layer base substrate, wherein, the Side of the two wearing layer base substrates away from the second repair layer base substrate is formed with arc-shaped concave, and the second wear-resistant elements layer base substrate has four Individual the second wear-resistant elements layer base substrate stacked gradually, the second repair layer has four the second reparation elementary layers stacked gradually.Most After the second sample blanks can be placed under repair as needed.

(7) by the first sample blanks and prior to 380 DEG C of the second sample blanks heat preservation sintering 30 minutes, then then at 260 DEG C of heat preservation sinterings 1.5 hours, the first soleplate and the second soleplate are obtained, that is, obtains the artificial intervertebral disk of the present embodiment.Wherein, it is formed with arc convex The first wear-resistant elements layer thickness be 80 microns, be formed with arc-shaped concave the second wear-resistant elements layer thickness be 80 microns.

Table 1 represent be after the friction of million times, the artificial intervertebral disk of 1~embodiment of embodiment 5 and comparative example 1 Wear rate and modulus of elasticity.Wherein, comparative example 1 is traditional only with the artificial intervertebral disk that polyether-ether-ketone is material.

Table 1

Wear extent

Modulus of elasticity

Embodiment 1	0.12mg/MC	20.54GPa
			Embodiment 2	0.07mg/MC	21.87GPa
Embodiment 3	0.08mg/MC	21.10GPa
			Embodiment 4	0.05mg/MC	22.35GPa
Embodiment 5	0.40mg/MC	19.42GPa
			Comparative example 1	2.50mg/MC	(3.86±0.72)GPa

As it can be seen from table 1 the wear extent of the artificial intervertebral disk of 1~embodiment of embodiment 5 is at most only 0.4mg/MC, most Few only 0.05mg/MC, and the wear extent of traditional artificial intervertebral disk of comparative example 1 is 2.5mg/MC, i.e. embodiment 1~5 Artificial intervertebral disk wear extent be only comparative example 1 artificial intervertebral disk wear extent 2.0%~14.5%, embodiment 1~ The wear rate of the artificial intervertebral disk of embodiment 5 is far below the wear rate of the artificial intervertebral disk of comparative example 1, i.e. embodiment 1~implementation The artificial intervertebral disk of example 5 has preferable anti-wear performance.

Can also be learnt from table 1, the modulus of elasticity of the artificial intervertebral disk of 1~embodiment of embodiment 5 for 19.42~ 22.35GPa, and the modulus of elasticity of people's bone be 17~20GPa, the modulus of elasticity of the artificial intervertebral disk of 1~embodiment of embodiment 5 with People's bone is sufficiently close to, i.e., have good biocompatibility with people's bone.And documents 1 is traditional only with polyether-ether-ketone The modulus of elasticity of artificial intervertebral disk is (3.86 ± 0.72) Gpa, it is clear that differ larger with the modulus of elasticity of people's bone, bio-compatible Property does not have the artificial intervertebral disk of 1~embodiment of embodiment 5 good.

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

Claims

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

First soleplate, includes the first wearing layer and the first repair layer of stacking, and first wearing layer is repaired away from described first The side of layer is formed with arc convex；And

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

Wherein, the first enhancing that the material of first wearing layer includes polyether-ether-ketone and is mixed in the polyether-ether-ketone is fine Dimension, the material of first repair layer includes polyether-ether-ketone and the first degradable active bone being mixed in the polyether-ether-ketone Repair materials, the second enhancing that the material of second wearing layer includes polyether-ether-ketone and is mixed in the polyether-ether-ketone is fine Dimension, the material of second repair layer includes polyether-ether-ketone and the second degradable active bone being mixed in the polyether-ether-ketone Repair materials, first active bone repair material and second active bone repair material be respectively selected from hydroxyapatite, α- At least one of tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass；

First wearing layer includes multiple the first wear-resistant elements layers stacked gradually, the material bag of each first wear-resistant elements layer The polyether-ether-ketone and first reinforcing fiber are included, the side from first wearing layer is to opposite side, the multiple first The weight/mass percentage composition of first reinforcing fiber in the material of wear-resistant elements layer is gradually decreased, and described first repairs layer stackup In on minimum first wear-resistant elements layer of the weight/mass percentage composition containing first reinforcing fiber, the arc convex is formed In on most first wear-resistant elements layer of the weight/mass percentage composition containing first reinforcing fiber；

Second wearing layer includes multiple the second wear-resistant elements layers stacked gradually, the material bag of each second wear-resistant elements layer The polyether-ether-ketone and second reinforcing fiber are included, the side from second wearing layer is to opposite side, the multiple second The weight/mass percentage composition of second reinforcing fiber in the material of wear-resistant elements layer is gradually decreased, and described second repairs layer stackup In on minimum second wear-resistant elements layer of the weight/mass percentage composition containing second reinforcing fiber, the arc-shaped concave is formed In on most second wear-resistant elements layer of the weight/mass percentage composition containing second reinforcing fiber；

The diameter of first reinforcing fiber and second reinforcing fiber is 1 nanometer~50 microns, and length is 10 microns ~1000 microns, the particle diameter of the polyether-ether-ketone in the material of the first wearing layer and the polyether-ether-ketone in the material of the second wearing layer is equal Less than 40 microns.

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

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

3. artificial intervertebral disk according to claim 1, it is characterised in that the quality percentage containing first reinforcing fiber contains The thickness of most first wear-resistant elements layer of amount is 50 microns~100 microns；

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

4. artificial intervertebral disk according to claim 1, it is characterised in that first repair layer includes multiple stack gradually First repair elementary layer, the material of each first repair layer elementary layer includes the polyether-ether-ketone and first active bone is repaiied Multiple material, from the side of first repair layer to opposite side, the multiple first repairs described the in the material of elementary layer The weight/mass percentage composition of one active bone repair material is gradually decreased, the weight/mass percentage composition containing first active bone repair material Minimum described first repairs elementary layer and the described first wear-resisting layer stackup；

Second repair layer includes multiple the second reparation elementary layers stacked gradually, and each second repairs the material bag of elementary layer The polyether-ether-ketone and second active bone repair material are included, the side from second repair layer is described more to opposite side The weight/mass percentage composition of second active bone repair material in the material of individual second reparation elementary layer is gradually decreased, containing described The weight/mass percentage composition of second the active bone repair material minimum second reparation elementary layer and the described second wear-resisting layer stackup.

5. artificial intervertebral disk according to claim 1, it is characterised in that first reinforcing fiber and second enhancing Fiber is respectively selected from carbon fiber, glass fibre, graphite fibre, silicon carbide fibre, stainless steel fibre and titanium-base crystal whisker fiber It is at least one.

6. artificial intervertebral disk according to claim 1, it is characterised in that the polyethers ether in the material of first repair layer The particle diameter of polyether-ether-ketone in the material of ketone and the second repair layer is respectively less than 40 microns.

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

8. a kind of preparation method of artificial intervertebral disk, it is characterised in that comprise the following steps：

The first degradable active bone repair material is mixed with polyether-ether-ketone, the first mixing material is obtained, wherein, described first Active bone repair material in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass extremely Few one kind；

The first mould is provided, first mould has the lower arcuate surface of evagination, by first mixed material and described first Mixing material is sequentially added in first mould, after shaping, removes first mould, and obtain including stacking first is resistance to The first sample blanks of layer base substrate and the first repair layer base substrate is ground, the first wearing layer base substrate is away from the first repair layer base substrate Side is formed with arc convex；

The second degradable active bone repair material is mixed with polyether-ether-ketone, the second mixing material is obtained, wherein, described second Active bone repair material in hydroxyapatite, type alpha tricalcium phosphate, bata-tricalcium phosphate, calcium sulfate and bioactivity glass extremely Few one kind；

The second mould is provided, second mould has the lower arcuate surface of indent, by second mixed material and described second Mixing material is sequentially added in second mould, after shaping, removes second mould, and obtain including stacking second is resistance to The second sample blanks of layer base substrate and the second repair layer base substrate is ground, the second wearing layer base substrate is away from the second repair layer base substrate Side is formed with arc-shaped concave；And

First sample blanks and second sample blanks are sintered respectively, the first soleplate and the second soleplate is obtained；

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