CN104707172B - A kind of artificial intervertebral disk and preparation method thereof - Google Patents
A kind of artificial intervertebral disk and preparation method thereof Download PDFInfo
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- CN104707172B CN104707172B CN201310686914.3A CN201310686914A CN104707172B CN 104707172 B CN104707172 B CN 104707172B CN 201310686914 A CN201310686914 A CN 201310686914A CN 104707172 B CN104707172 B CN 104707172B
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Abstract
The invention discloses a kind of preparation method of artificial intervertebral disk, comprises the following steps：The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；Step 2, by the artificial disc after arthroplasty be placed in acetone soln be cleaned by ultrasonic, deionized water cleaning, sterilization；Step 3, the artificial disc after arthroplasty being disposed in step 2 is impregnated in the PBS solution of acid-soluble collagen protein, after a few days the artificial disc after arthroplasty for being adsorbed with collagen protein is taken out, in the PBS solution of immersion cross-linking agent, adjust pH >=7.4, then take out, artificial disc after arthroplasty soleplate up and down gently Deca rhBMP 2 PBS solution formed water membrane, artificial disc after arthroplasty is slowly immersed in into Na again after vacuum drying2HPO4In solution, then take out and cleaned with PBS solution；Step 4, by the artificial disc after arthroplasty in step 3 be placed in be dried, sterilizing, you can obtain artificial intervertebral disk.The invention also discloses the artificial intervertebral disk prepared using above-mentioned preparation method.
Description
Technical field
The present invention relates to a kind of artificial intervertebral disk and preparation method thereof, refers in particular to a kind of and cervical bone good fitting
And the better artificial intervertebral disk of post-operative recovery and preparation method thereof.
Background technology
Disc replacement（Total Disc Replacement, TDR）Carry out abroad it is relatively early, intervertebral disk prosthesis it is general
Read and proposed by French scholar Van Steenbrugghe in 1956, his imagination substitutes the intervertebral disc of regression with intervertebral disk prosthesis,
While patients symptomatic is released, the stability and activeness of operated level are kept.1973, Urbaniak etc. reported first
The zoopery of example artificial disc replacement.From this, various intervertebral disk prosthesis occur in succession.In January, 2000, the world are first
Example artificial cervical intervertebral disc is implanted into human body, in June, 2004 U.S.'s food and FAD in the U.S.（FDA）Official approval is used
The human body of artificial cervical intervertebral disc is used.At present, artificial cervical intervertebral disc achieves the effect of preferable treatment in worldwide
Really.Artificial cervical intervertebral disc design object is the normal cervical vertebrate active degree for recovering, maintaining discectomy postoperative.Neck artificial intervertebral
Disk has fixed and two kinds of relative motion, and its material is in addition to possessing the requirement for being typically implanted thing, it is necessary to wear-resisting, corrosion-resistant, at present absolutely
Great majority use cochrome and ultra-high molecular weight polyethylene.Neck artificial intervertebral disk is at once fixed depending on surrounding soft tissue's tension force
And mechanical system, long-term fixed growing into by bone.From last century with regard to the nineties since, particularly recent years, artificial intervertebral
Disc prosthesis are designed and clinical research develops gradually maturation.The neck artificial intervertebral's disc-type for having been enter into clinical trial at present has
Prestige, Bryan, Prodisc-C, PCM, CerviCore etc..Wherein Bryan prostheses are most widely used, clinical quantity
At most, the portion in the U.S. reports display with regard to using for Bryan intervertebral disc, from the Bryan of in January, 2000 cervical intervertebral disk clinic trial
By 2002, in addition to the U.S., there are 17 countries to use more than 2000 Bryan intervertebral disk prosthesis.In June, 2004 U.S.'s food
And FAD（FDA）Official approval is used using the human body of artificial cervical intervertebral disc.At present, artificial cervical intervertebral disc is complete
The effect of preferable treatment is achieved in world wide.
China about introduced artificial disc replacement's operation at 2003 or so, mainly using imported product, wherein being implanted into
The case load of Bryan type artificial disc after arthroplasty at most, also has using the artificial of its alloytype such as Link SB Charit é I-II types
Intervertebral disc, it is accumulative to have had 1000 artificial disc replacement's operation cases.
With regard to the clinical trail evaluation of patient's cervical vertebra recovery effects after artificial intervertebral disk implantation, and its biomechanics is commented
Valency has gradually been seen in research paper report, but, report is not yet seen in using domestic artificial intervertebral disk at present.It is in China, right
The research and development of domestic artificial intervertebral disk are almost blank.
The shortcoming of prior art is that the design of external artificial intervertebral disk is designed according to the cervical vertebra anatomical features of European ethnic group
, and the relatively European ethnic group of Chinese human model is less, cervical vertebra is also relatively small, and the dimension series of external artificial intervertebral disk can not be very
Good adaptation Chinese ethnic group cervical vertebra feature, because being replaced not according to the domestic brand design being directed to reluctantly, surgical effect will
Big heavy discount, is unfavorable for the permanent rehabilitation of displacer.And generally lack the surface by fixed active substance in current art
Modification technology.
People's recombinant human bone morphogenetic protein-2 in active substance（rhBMP-2）It is a kind of locality growth promotion and differentiation factor,
Numerous studies show that rhBMP-2 can be obviously promoted spinal fusion rate at present, accelerate spinal fusion.From a large amount of zooperies and face
Bed nearly thousand patient data observations so far, rhBMP-2 is safe for spinal fusion.
The content of the invention
The technical problem to be solved is to provide one kind with cervical bone good fitting and post-operative recovery effect is good
Artificial intervertebral disk and the method for preparing the artificial intervertebral disk.
The technical scheme that adopted of technical problem for solving the present invention is：A kind of preparation method of artificial intervertebral disk is provided,
Which comprises the following steps：
A kind of preparation method of artificial intervertebral disk, it is characterised in that comprise the following steps：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, the artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic, deionized water cleaning, sterilizing disappears
Poison；
Step 3, the artificial disc after arthroplasty being disposed in step 2 impregnated in the acid-soluble of 1 μ g/ml-1mg/ml
In the PBS solution of collagen protein, the artificial disc after arthroplasty for being adsorbed with collagen protein is gently taken out after 1-3 days, immerse 0.1%-
1- ethyl -3- (3- the dimethyl aminopropyls)-carbodiimides and the PBS solution of N-hydroxy-succinamide of 5% mass fraction
In, pH >=7.4 are adjusted, is then taken out, in the gently Deca 1 μ g/ml-1mg/ml of soleplate up and down of artificial disc after arthroplasty
The PBS solution of rhBMP-2 forms water membrane, vacuum drying, then the Na that artificial disc after arthroplasty is slowly immersed in 0.1M2HPO4
In solution, then take out and cleaned with PBS solution；
Step 4, by the artificial disc after arthroplasty being disposed in step 3 be placed in be dried, sterilizing, you can obtain artificial vertebra
Intercalated disc.
Preferably, in step 2, it is cleaned by ultrasonic the time for 30 minutes, deionized water is cleaned at least three times.
Preferably, in step 3, impregnation steps are replaced with following steps：
Directly the liquid film of the PBS solution of the acid-soluble collagen protein of 1mg/ml-3mg/ml is covered, is vacuum dried.
Preferably, in step 3,1- ethyl -3- (3- dimethyl aminopropyls)-carbodiimides and N- hydroxysuccinimidyl acyls
Imines replaces with glutaraldehyde, hexamethylene diisocyanate, genipin, epoxide, diphenylphosphine hydrochlorate, bis- (3,4- of 1,4-
Hydroxy benzeness) -2,3- dimethylbutanes.
Preferably, in step 3, the molecular weight of the acid-soluble collagen protein is more than 100KD.
Preferably, in step 4, artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, oxirane goes out
Bacterium.
Another technical scheme that adopted of technical problem for solving the present invention is：Using the preparation side of above-mentioned artificial intervertebral disk
Artificial intervertebral disk prepared by method.
Compared with prior art, artificial intervertebral disk of the invention is using implantation stage polyetheretherketoneresin（PEEK）According to Design and Machining
Go out the artificial disc after arthroplasty of certain size, and restructuring is combined using I-type collagen with vertebra contact portion in upper and lower surface
Human bone morphogenesis protein-2（rhBMP-2）Surface modification technology artificial intervertebral disk is done surface be modified, realize and neck bone
The good fitting of bone, post-operative recovery are better.
Description of the drawings
Fig. 1 is the axonometric chart of the artificial intervertebral disk of the present invention.
Fig. 2 is the top view of the artificial intervertebral disk of the present invention.
Fig. 3 be the present invention artificial intervertebral disk surface before modified after water contact angle change schematic diagram.
Fig. 4 is scanning electron microscope (SEM) photograph of the artificial intervertebral disk of the present invention on surface before modified.
Fig. 5 is the artificial intervertebral disk of the present invention in the modified scanning electron microscope (SEM) photograph in surface.
Specific embodiment
In order that the objects, technical solutions and advantages of the present invention become more apparent, it is below in conjunction with drawings and Examples, right
The present invention is further elaborated.It should be appreciated that specific embodiment described herein is only to explain the present invention, and
It is not used in the restriction present invention.
The present invention is based on CT image cervical vertebra threedimensional models, determines Chinese's intervertebral disc of cervical vertebra statistical parameter, using computer
Auxiliary design method designs artificial cervical intervertebral disc structure.From polyetheretherketonematerials materials, polyetheretherketonematerials materials have and cortical bone
Similar elastic modelling quantity, will not produce artifact etc. with good biocompatibility, lonizing radiation permeability, magnetic resonance imaging in addition
Advantage, is extraordinary bone material.As the artificial disc after arthroplasty being modified without surface often occurs the phenomenons such as loosening, sinking,
The implantation effect of artificial disc after arthroplasty is had a strong impact on and has caused cervical vertebra ache, pain has forced patient to carry out second operation, changes
Pain is eliminated with the mode of intervertebral fusion.And carry out surface with the protein with biological activity and fix, make artificial intervertebral disk
Top and bottom surface faster and bone fusion can reach more preferably post-operative recovery effect.
Intervertebral disc uses polyether-ether-ketone（PEEK）For main material, and I type is adopted with vertebra contact portion in upper and lower surface
Collagen protein combines rhBMP-2（rhBMP-2）Surface modification technology surface done to artificial intervertebral disk change
Property, the good fitting with cervical bone is realized, post-operative recovery is better.
In order to build the threedimensional model of human cervical spine spinal column, volunteer's spinal column is scanned first with CT, is gathered
To the CT data of volunteer's cervical vertebra, based on these CT data, cervical vertebra is selected by given threshold segmentation using software MIMICS, so
After calculate threedimensional model, finally obtain from CT data the cervical vertebra threedimensional model for extracting.Threedimensional model is measured, vertebral body is obtained
Between distance and vertebral body cross section it is maximum away from.To there is volunteer's data to carry out statistical analysiss more.Set up according to Chinese CT data
Artificial intervertebral disk, more preferably can be matched with Chinese cervical vertebra, improve surgical effect, beneficial to the permanent rehabilitation of displacer.
The making of prosthese is the CT data and reconstruction model based on patient, can be based on Chinese's cervical vertebra stock size batch
Manufacture, also can be used for the personalized customization of patient, meet single segmental and multi-segmental implantation demand.
According to statistical data analysis, the basic size of artificial intervertebral disk is determined, design artificial intervertebral disk threedimensional model（As schemed
Shown in 1）.The upper and lower surface of the artificial intervertebral disk 10 is respectively arranged the projection 12 that six sections are triangle, by artificial intervertebral
Disk is combined with operation with surrounding sclerotin and fixes at once.
The artificial intervertebral disk 10 is demountable structure：Upper and lower endplate structure, upper endplate structure haveChou
Structure, has the groove coordinated with upper soleplate hemisphere in lower soleplate, the structure can realize certain mobility of intervertebral disc, and pass through
The vertebral body freedom of movement of finite element analyses and structure optimization, this freedom of movement and people is similar.
The present invention also provides a kind of preparation method of artificial intervertebral disk, comprises the following steps：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, polyether-ether-ketone artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water is clear
Wash several times（At least 3 times）, moist heat sterilization sterilization；
In step 3, the PBS solution of the acid-soluble collagen protein that polyether-ether-ketone prosthese impregnated in 1 μ g/ml-1mg/ml,
The prosthese for being adsorbed with collagen protein is gently taken out after 1-3 days（Impregnation steps herein may also be employed direct 1mg/ml-3mg/ml
The liquid film of the PBS solution of acid-soluble collagen protein is covered, vacuum drying）, immerse the 1- ethyl -3- (3- of 0.1%-5% mass fractions
Dimethyl aminopropyl)-carbodiimides (EDC) and N-hydroxy-succinamide (NHS) PBS solution in (adjust pH >=7.4),
Take out after 1h, in the PBS solution shape of the gently rhBMP-2 of 1 μ g/ml-1mg/ml of Deca of soleplate up and down of artificial disc after arthroplasty
Into water membrane, after vacuum drying, then the Na that artificial disc after arthroplasty is slowly immersed in 0.1M2HPO4In solution, take after 10min
Go out, PBS solution is cleaned 4 times, each 30min；
Step 4, prosthese is placed in normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, artificial intervertebral is obtained
Disk, is then packed with sterilizing bag, 4 DEG C of preservations.
Preferably, 1- ethyls -3- (3- dimethyl aminopropyls)-carbodiimides (EDC) and N-hydroxy-succinamide
(NHS) other similar cross-linking agent, such as glutaraldehyde be can be replaced（GTA）, hexamethylene diisocyanate（HDI), genipin
（Genipin）, epoxide（EC）, diphenylphosphine hydrochlorate（DPPA）, 1,4- bis- (3,4- hydroxy benzeness) -2,3- dimethylbutanes
（NDGA）Deng protein cross agent.Preferably, the molecular weight of the acid-soluble collagen protein is more than 100KD.
The preparation method and other features of the artificial intervertebral disk are specifically described further below by way of specific embodiment.
Embodiment one：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, by the artificial disc after arthroplasty be placed in acetone soln be cleaned by ultrasonic 30 minutes（min）, deionized water is clear
Wash several times, moist heat sterilization sterilization；
Step 3, the artificial disc after arthroplasty impregnated in the PBS solution of acid-soluble collagen protein of 1mg/ml, 1 day
Afterwards the artificial disc after arthroplasty for being adsorbed with collagen protein is gently taken out, the PBS solution of the EDC/NHS of 1% mass fraction is immersed
In, after 1h take out, the upper and lower soleplate of the artificial disc after arthroplasty gently the rhBMP-2 of 10 μ g/ml of Deca PBS solution formed one
Layer moisture film, after vacuum drying, then the Na that the artificial disc after arthroplasty is slowly immersed in 0.1M2HPO4In solution, take out after 10min,
PBS solution is cleaned 4 times, and each time is 30min；
Step 4, the artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can
To the artificial intervertebral disk that surface is modified, then packed with sterilizing bag, 4 DEG C of preservations.
Embodiment two：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, the artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water cleaning number
Time, damp and hot sterilization；
Step 3, the artificial disc after arthroplasty upper and lower soleplate is contacted with vertebra two sides respectively use the acid-soluble collagens of 1mg/ml
The liquid film of the PBS solution of albumen is covered, vacuum drying oven normal temperature drying, immerses the PBS solution of the EDC/NHS of 1% mass fraction
In, take out after 1h, formed in the PBS solution of the upper and lower soleplate of the artificial disc after arthroplasty gently rhBMP-2 of 100 μ g/ml of Deca
Water membrane, after vacuum drying, then the Na that artificial disc after arthroplasty is slowly immersed in 0.1M2HPO4In solution, take out after 10min,
PBS solution is cleaned 4 times, and each time is 30min；
Step 4, the artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can
To the artificial intervertebral disk that surface is modified, then packed with sterilizing bag, 4 DEG C of preservations.
Embodiment three：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, the artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water cleaning number
Time, moist heat sterilization sterilization；
In step 3, the PBS solution of the acid-soluble collagen protein that the artificial disc after arthroplasty impregnated in 500 μ g/ml, 3
Artificial disc after arthroplasty for being adsorbed with collagen protein is gently taken out after it, immerse the PBS solution of the EDC/NHS of 5% mass fraction
In, after 1h take out, the upper and lower soleplate of artificial disc after arthroplasty gently the rhBMP-2 of Deca 1mg/ml PBS solution formed one layer
Moisture film, after vacuum drying, then the Na that prosthese is slowly immersed in 0.1M2HPO4In solution, take out after 10min, PBS solution cleaning 4
It is secondary, 30min is needed every time.
Step 4, artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can obtain
The modified artificial intervertebral disk in surface, is then packed with sterilizing bag, 4 DEG C of preservations.
Example IV：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water is cleaned several times,
Moist heat sterilization is sterilized；
Step 3, artificial disc after arthroplasty impregnated in the PBS solution of acid-soluble collagen protein of 1mg/ml, after 1 day
The artificial disc after arthroplasty for being adsorbed with collagen protein is gently taken out, in the PBS solution of the EDC/NHS for immersing 1% mass fraction,
After 1h take out, the upper and lower soleplate of artificial disc after arthroplasty gently the rhBMP-2 of 10 μ g/ml of Deca PBS solution formed one layer of water
Film, after vacuum drying, then the Na that artificial disc after arthroplasty is slowly immersed in 0.1M2HPO4In solution, take out after 10min, PBS is molten
Liquid is cleaned 4 times, needs 30min every time；
Step 4, the artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can
To the artificial intervertebral disk that surface is modified, then packed with sterilizing bag, 4 DEG C of preservations.
Embodiment five：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water is cleaned several times,
Moist heat sterilization is sterilized；
Step 3, artificial disc after arthroplasty upper and lower soleplate is contacted with vertebra two sides respectively use the acid-soluble collagen eggs of 3mg/ml
The liquid film of white PBS solution is covered, vacuum drying oven normal temperature drying, in the PBS solution of the EDC/NHS for immersing 3% mass fraction,
After 1h take out, the upper and lower soleplate of prosthese gently the rhBMP-2 of 10 μ g/ml of Deca PBS solution formed water membrane, vacuum drying
Artificial disc after arthroplasty is slowly immersed in the Na of 0.1M afterwards again2HPO4In solution, take out after 10min, cleaned with PBS solution 4 times,
Each 30min.
Step 4, artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can obtain
The modified artificial intervertebral disk in surface, is then packed with sterilizing bag, 4 DEG C of preservations.
Embodiment six：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water is cleaned several times,
Moist heat sterilization is sterilized；
Step 3, artificial disc after arthroplasty upper and lower soleplate is contacted with vertebra two sides respectively use the acid-soluble collagen eggs of 3mg/ml
The liquid film of white PBS solution is covered, vacuum drying oven normal temperature drying, in the PBS solution of the genipin for immersing 1% mass fraction, 1h
After take out, the upper and lower soleplate of prosthese gently the rhBMP-2 of 100 μ g/ml of Deca PBS solution formed water membrane, vacuum drying
Artificial disc after arthroplasty is slowly immersed in the Na of 0.1M afterwards again2HPO4In solution, take out after 10min, cleaned with PBS solution 4 times,
Each 30min.
Step 4, artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can obtain
The modified artificial intervertebral disk in surface, is then packed with sterilizing bag, 4 DEG C of preservations.
Embodiment seven：
The artificial disc after arthroplasty that step one, offer are made using implantable stage polyetheretherketoneresin material；
Step 2, artificial disc after arthroplasty is placed in acetone soln it is cleaned by ultrasonic 30min, deionized water is cleaned several times,
Moist heat sterilization is sterilized；
Step 3, artificial disc after arthroplasty upper and lower soleplate is contacted with vertebra two sides respectively use the acid-soluble collagen eggs of 3mg/ml
The liquid film of white PBS solution is covered, vacuum drying oven normal temperature drying, in the PBS solution of the glutaraldehyde for immersing 1% mass fraction,
Take out after 10h, deionized water is cleaned 4 times, and each 30min dries naturally, in the upper and lower soleplate of prosthese gently Deca 100 μ g/ml
The PBS solution of rhBMP-2 forms water membrane, and artificial disc after arthroplasty is slowly immersed in after vacuum drying the Na of 0.1M again2HPO4
In solution, take out after 10min, cleaned with PBS solution 4 times, each 30min.
Step 4, artificial disc after arthroplasty is placed in into normal temperature drying in vacuum drying oven, ethylene oxide sterilizing, you can obtain
The modified artificial intervertebral disk in surface, is then packed with sterilizing bag, 4 DEG C of preservations.
Polyether-ether-ketone（PEEK）As hydrophobic structure, 75 ° of water contact angle ＞, collagen protein is hydrophilic-structure to material sheet, when
After PEEK surface covering rubbers original albumen, water contact angle occur one it is hydrophobic to hydrophilic transformation, as shown in Figure 3.
Fig. 4 is scanning electron microscope (SEM) photograph of the artificial intervertebral disk of the present invention on surface before modified.Fig. 5 is the artificial intervertebral of the present invention
Disk is in the modified scanning electron microscope (SEM) photograph in surface.The surface Electronic Speculum of the PEEK disc materials obtained using the method for machining is shone
Piece, no collagen protein absorption, is compareed with Fig. 5.As shown in figure 5, having apparent collagen protein absorption and the structure being crosslinked.
Cell propagation-the toxicity of PEEK materials is tested, the CCK-8 methods of employing are measured and monitored the growth of standing timber and expect superficial cell propagation feelings
Condition, cell viability and absorbance（OD values）Linear relationship.Experiment finds that the PEEK of collagen protein adsorption of modification does not have cytotoxicity,
Cell proliferative conditions are normal, and the modified PEEK materials in surface do not have cytotoxicity.
The present invention adopts Chinese's CT data, sets up cervical vertebra threedimensional model, measures, and is set up according to statistical data analysis
Artificial intervertebral disk, it is to avoid the dimension series of external artificial intervertebral disk can not well adapt to Chinese ethnic group cervical vertebra feature, because
Replaced not according to the domestic brand design being directed to reluctantly, surgical effect by the situation of big heavy discount, the present invention with sclerotin
Binding site, separately design 6 it is raised, using operation fix at once, improve procedure efficiency.
Using implantable stage polyetheretherketoneresin（PEEK）The artificial intervertebral disk of certain size is gone out according to Design and Machining, and upper and lower
Surface is combined rhBMP-2 using I-type collagen with vertebra contact portion（rhBMP-2）Surface repair
Decorations technology is done surface and is modified to artificial intervertebral disk, i.e., with the method for carbodiimide class cross-linking agents in people after physical absorption
The protein such as collagen protein are fixed on work intervertebral disk prosthesis surface, realize the good fitting with cervical bone, and post-operative recovery effect is more
It is good.
Presently preferred embodiments of the present invention is the foregoing is only, not to limit the present invention, all essences in the present invention
Any modification, equivalent and improvement made within god and principle etc., should be included within the scope of the present invention.
Claims (6)
1. a kind of preparation method of artificial intervertebral disk, it is characterised in that comprise the following steps：
Step one, set up cervical vertebra threedimensional model, there is provided make using the implantable stage polyetheretherketoneresin material and cervical vertebra is three-dimensional
The corresponding artificial disc after arthroplasty of model；
Step 2, by the artificial disc after arthroplasty be placed in acetone soln be cleaned by ultrasonic, deionized water cleaning, sterilization；
Step 3, the acid-soluble collagen that the artificial disc after arthroplasty being disposed in step 2 impregnated in 1 μ g/ml-1mg/ml
In the PBS solution of albumen, the molecular weight of the acid-soluble collagen protein is more than 100KD, will be adsorbed with collagen protein after 1-3 days
Artificial disc after arthroplasty takes out, and 1- ethyl -3- (3- the dimethyl aminopropyls)-carbonization two for immersing 0.1%-5% mass fractions is sub-
In the PBS solution of amine and N-hydroxy-succinamide, pH >=7.4 are adjusted, is then taken out, in the whole up and down of artificial disc after arthroplasty
The PBS solution of the plate gently rhBMP-2 of 1 μ g/ml-1mg/ml of Deca forms water membrane, vacuum drying, then by artificial intervertebral disk
Prosthese is slowly immersed in the Na of 0.1M2HPO4In solution, then take out and cleaned with PBS solution, in upper and lower surface and vertebra contact site
Divide and the surface modification technology of rhBMP-2 (rhBMP-2) is combined to artificial intervertebral using I-type collagen
Disk does surface and is modified；
Step 4, the artificial disc after arthroplasty being disposed in step 3 is dried, is sterilized, you can obtain artificial intervertebral
Disk.
2. preparation method according to claim 1, it is characterised in that in step 2, it is 30 minutes to be cleaned by ultrasonic the time,
Deionized water is cleaned at least three times.
3. preparation method according to claim 1, it is characterised in that in step 3, impregnation steps are replaced with following steps
Change：
Directly the liquid film of the PBS solution of the acid-soluble collagen protein of 1mg/ml-3mg/ml is covered, is vacuum dried.
4. preparation method according to claim 1, it is characterised in that in step 3,1- ethyl -3- (3- dimethylaminos
Propyl group)-carbodiimides and N-hydroxy-succinamide replace with glutaraldehyde, hexamethylene diisocyanate, genipin, epoxidation
Compound, diphenylphosphine hydrochlorate, 1,4- bis- (3,4- hydroxy benzeness) -2,3- dimethylbutanes.
5. preparation method according to claim 1, it is characterised in that in step 4, artificial disc after arthroplasty is placed in
Normal temperature drying in vacuum drying oven, ethylene oxide sterilizing.
6. the artificial intervertebral disk that prepared by a kind of preparation method according to claim 1-5 any one.
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| GB2536388B (en) * | 2016-06-29 | 2017-05-10 | Invibio Ltd | Phosphate stabilised polyetheretherketone (PEEK) and use thereof |
| GB2536387B (en) * | 2016-06-29 | 2017-05-10 | Victrex Mfg Ltd | Preparation of phosphate stabilised polyetheretherketone (PEEK) |
| CN109045359A (en) * | 2018-08-09 | 2018-12-21 | 深圳市光明创博生物制品发展有限公司 | A kind of composite bio-active material and preparation method thereof for Maxillofacial defect reparation |
| CN110101907B (en) * | 2019-05-06 | 2022-03-29 | 大连理工大学 | Surface physically modified polyaryl ether bone implant material containing phthalazinone structure and preparation method thereof |
| CN112690932B (en) * | 2020-12-25 | 2023-07-28 | 北京爱康宜诚医疗器材有限公司 | Method for processing vertebral prosthesis |
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