CN104707182B - Intervertebral implant - Google Patents
Intervertebral implant Download PDFInfo
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- CN104707182B CN104707182B CN201310696169.0A CN201310696169A CN104707182B CN 104707182 B CN104707182 B CN 104707182B CN 201310696169 A CN201310696169 A CN 201310696169A CN 104707182 B CN104707182 B CN 104707182B
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Abstract
A kind of intervertebral implant, it is that stent model is inserted after metal-powder through thermal sintering using porous oxyhydrogen-base apatite to particularly relate to a kind of, the intervertebral implant of the local degradable oxyhydrogen-base apatite/metal block material of composition, progressively degraded with implantation human body time oxyhydrogen-base apatite structure, and inducting osseous tissue is sought connections with inside porous metals, firm top and bottom bone syncretizing effect are formed.
Description
Technical field
The present invention relates to a kind of medical implant technical field, specifically refer to that a kind of part is degradable and in porous type
The intervertebral implant of state, uses composition local degradable oxyhydrogen-base apatite and metal mixed bulk, so that Guided Bone Regeneration
And form the effect of firm upper and lower part bone fusion.
Background technology
Press, lumbar intervertebral fusion, it is intended that take out interverbebral disc from two section vertebras, then the two fusion is got up.This
Step also known as " spinal fusion ".Be generally used for treatment degenerated by vertebra, the rachiopathy such as disc herniation and continuing for being led to
Backache, sciatica or the aching and limp sufferer such as powerless of both legs.Spinal fusion is also correction deformity of spine (such as scoliosis, vertebra
Slip or spinal trauma etc.) the wherein important step of operation.
If repairing the planting body (or to repair the implant of bone tissue) of bone tissue while support function is provided
It is biological absorbable, great benefit is had in practical application.Existing spinal fusion device is by a metallic framework
Constituted with bioabsorbable material disposed within, such as U.S. Patent number 5, the device shown in 645,598.Only, those are used
It is placed in repairing the planting system of bone tissue between two section vertebraes, but for fear of hardness of planting body deficiency itself and relative volume
Less than the vertebrae, cause the planting body to produce sinkage, on the contrary mutually abrasion even destroy vertebrae and vertebrae it
Between bone tissue, be even more to bring grievous injury particularly to the end plane of vertebrae.
In addition, currently used for organizational engineering technology support (most of be made up of biodegradable polymer) have it is many
The structure in hole can allow active somatic cell in cell cultivation process (being normally taken from the patient in treatment) to penetrate into structure.By one
The cell culture of section time, such a support for having cell is implanted the animal (such as rat) for removing immune system or sufferers themselves
In vivo (being typically subcutaneous for ease of subsequent operation).(several weeks to several months) cell absorbs during this period carries in animal or patient's body
The nutritional ingredient of confession and breed rapidly, while support gradually solution absorption in itself.Afterwards, just from the subcutaneous taking-up of animal or patient
Planting body (a real bone tissue), again implantation needs (the injured or ill) position treated.Such as US6,139,578；
US6,200,606；The case one depicted such as US5,306,303 and US6,132,463.
But, if the support for tissue engineering technique be able to can be provided by bio-absorbable, the hole for having abundance simultaneously again
Support, then such material just has an enormous advantage.Wherein such as Chinese patent CN 119346A：It is a kind of containing pore former
Porous calcium phosphate bone cement, it is characterised in that be made up of conventional calcium phosphate bone cement and pore former, described pore former
For the one or more in slightly soluble salt, acid salt and basic salt or surfactant.But it is without fixed kenel bone water
Mud, its bad mechanical strength, it is impossible to alone as bone fusion thing.
And for example Chinese patent CN 101099873A：A kind of manufacturing technique method of porous magnesium/hydroxyapatite, its feature
It is to mix hydroxylapatite powder and magnesium powder in proportion, then cold moudling be sintered, vaporization, quilt occur at high temperature for magnesium
Evaporation, makes hydroxyapatite formation cellular.After only magnesium high temperature is removed, porous oxyhydrogen-base apatite body is only remained, is equally existed
The problem of having bad mechanical strength.
For another Chinese patent CN 101797400A：One kind contains HA nm powder porous degradable magnesium alloy bone scaffold materials,
Characterized in that, magnesium powder, HA nm of the described porous degradable magnesium alloy bone scaffold material by the micro refinement Zn crystal grain of addition
Powder, and pore creating material composition, interim, micro- 50~80%, the HA nms powder of magnesium-zinc alloy powder is 10~20%, pore creating material composition, its
In, micro- 50~80%, the HA nms powder of magnesium-zinc alloy powder is 10~20%, and pore creating material is 10~30%.After only magnesium high temperature is removed, only
Remain porous oxyhydrogen-base apatite body, the problem of equally there are bad mechanical strength.
Furthermore, conventional high temperature is (generally>1000 DEG C) poroid hydroxyapatite (HA) material of sintering do not possess enough micro-
Rice/nano level hole and it is difficult to be absorbed by organism.On the other hand, conventionally used for skeleton biodegradable polymers again
Have the shortcomings that intensity is relatively low and rate of dissolution is too high.In other words in the case where considering lightweight, the preceding topic of the biological combination of increase,
It is necessary that development can promote the connected porous metal of bone guided to cure material.
Inventor is in view of every shortcoming derived from connected porous metal doctor's material of above-mentioned known promotion bone guided, is
Urgently think to be improved innovation, successfully research and development complete a kind of intervertebral implant of this part finally.
The content of the invention
The purpose of the present invention is to be to provide a kind of intervertebral implant, and local degradable hydroxy phosphorus ash can be constituted by using
The intervertebral implant of stone/metal block material, is progressively degraded, and guide bone group with implantation human body time oxyhydrogen-base apatite structure
Knit and seek connections with inside porous metals, form firm top and bottom bone syncretizing effect.
Time purpose of the present invention is to provide a kind of intervertebral implant, for dropping using ceramic material or metal material
High polymer material or compound are solved, the material with excellent properties and structure is manufactured and designed according to bionic principle, and with regulation
The degradation rate of material.
Another object of the present invention is to provide a kind of timbering material for the biological behaviour and culture efficiency for possessing cell,
After intervertebral implant is transplanted can with people's body cavity hole have well adapt to, with reference to and repair intervertebral implant.
The further object of the present invention is to provide a kind of intervertebral implant with good bio-compatibility, intervertebral plant
Enter and possess no cytotoxicity when thing is cultivated in vitro, the advantage of the rejection of human body bone will not be caused when in implantation human body.
A further object of the present invention is to provide a kind of intervertebral implant, and the intervertebral implant has 3-D solid structure,
And with highly porous shape structure, the intervertebral implant has very big internal surface area, to be conducive to implantation, the adhesion of cell,
Be conducive to the infiltration of cytotrophy composition and the discharge of metabolite again.
His purpose of the present invention is to provide a kind of intervertebral implant, and there is the intervertebral implant good surface to live
Property, the adhesion of cell can be promoted and the propagation for cell on its surface provides good microenvironment.
It may achieve foregoing invention first purpose kind intervertebral implant, to be that stent model is filled out using porous oxyhydrogen-base apatite
Enter through thermal sintering after metal-powder, the intervertebral implant of the local degradable oxyhydrogen-base apatite/metal block material of composition, it is made
Preparation Method, comprises the following steps：
Step a, mixing：It is able to will be stirred in the degradable biological material that degradation is produced in human body with adhesive liquid
Mix, and form a kind of micro- thick liquid；
Step b, it is stained with and covers：It is stained with to be covered with porous polymeric stent and states micro- thick liquid so that the polymeric stent table
Micro- thick liquid is coated with face and/or the space of its chamber hole shape；
Step c, drying and shaping：And dried after completion is stained with and covered, micro- thick liquid is closely coated in macromolecule
Support and chamber hole shape are spatially, and different from the original porous arrangement of chamber hole shape space according to polymeric stent, are closely coated in top layer
And the porous arrangement of identical is presented；
Step d, sintering are removed：High temperature sintering is carried out with air body of heater, and polymeric stent and adhesive are removed, to obtain
Obtain a degradable biological material support of porous arrangement；And
Step e, filling are around knot：It is that stent model inserts metal-powder using the degradable biological material support, and carries out true
Empty high temperature sintering, to obtain by degradable biological material and metal-powder a mutually chimeric intervertebral implant.
Thereby, implementing through above-mentioned technological means so that the permeable oxyhydrogen-base apatite biomaterial of the present invention
With good biological compatibility, osteoconductive and biological degradability, after the intervertebral implant of oxyhydrogen-base apatite/metal block material is interior
Can gradually occur dissolving and biodegradable, lifeless oxyhydrogen-base apatite intervertebral implant, which gradually dissolves, after certain time disappears
Lose, replaced by lived freshman bone tissue, also using the intervertebral implant implantation human body of oxyhydrogen-base apatite/metal block material
Chamber hole, gradually inducting osseous tissue grows into chamber after the intervertebral implant of oxyhydrogen-base apatite/metal block material is implanted into people's body cavity hole
Hole shape space, while growing into for soft tissue is prevented, so as to realize the intervertebral implant of oxyhydrogen-base apatite/metal block material in human body
Firm mechanical bond in bone, and the surcharge of product can be effectively increased, and lift its economic benefit.
Brief description of the drawings
Fig. 1 is a kind of brief schematic flow sheet of intervertebral implant of the invention；
Schematic diagram is made in the step of Fig. 2 is a kind of intervertebral implant；
Fig. 3~Fig. 6 be cell divide in porous metal structure surface show be all normal condition cell behavior action diagram.
Embodiment
Referring to Fig. 1, a kind of intervertebral implant provided by the present invention, it is to be total to by metal-powder with degradable biological material
With composition；Wherein, the degradable biological material it is sintered and with plural intercommunicating pore, the metal-powder is then filled in the plural number and connected
In hole, and it is sintered and mutually chimeric with the degradable biological material.Thereby, the degradable biological material contained by the intervertebral implant
Then it can be dissolved by body fluid and cell-mediated biodegradation, a part participates in bone tissue and is implanted into local or long-range bone tissue weight
Build, another part is gradually metabolized system and excreted, defect is substituted completely by newborn bone tissue, and the gold
Category support plays permanent support effect, i.e. bone tissue engineering stent material simultaneously.Based on this, the degradable biological material also may be selected
Replaced by absorbable biological material, the effect of to reach as previously described according to principle of identity.
Continuous ginseng Fig. 1 and 2, the intervertebral implant is made up of the following steps, comprising：Step a, mixing：Can be in production in human body
The degradable biological material of raw degradation is stirred with adhesive liquid, 1100~1300 DEG C of its whipping temp, stirring mixing
Time is 10~60min, and forms a kind of micro- thick liquid；Wherein, the degradable biological material can be selected as hydroxy phosphorus ash
Stone, and the adhesive can be then selected as polyvinyl acetate (also referred to as polyvinyl acetate, abbreviation PVA, PVAc), it belongs to
A kind of flexible synthetic polymer, preferably, the present embodiment mixes polyvinyl acetate by oxyhydrogen-base apatite, to be formed
Oxyhydrogen-base apatite/PVA slurries as shown in Figure 2；
Step b, it is stained with and covers：With the polymeric stent (high-molecular support) of porous and above-mentioned micro- viscous fluid
Body be stained with cover operation and in being coated with micro- thick liquid in polymeric stent surface and/or the space of chamber hole shape；Wherein should
Polymeric stent is made by ceramic material or metal material, and its all polymeric stent as shown in Figure 2 has plural chamber hole shape
Space；
Step c, drying and shaping：And complete to be stained with to cover to be dried after baking oven, 50~100 DEG C of drying temperature, drying is fixed
The type time is 8~24hr, micro- thick liquid is closely coated in polymeric stent surface and/or chamber hole shape spatially, and according to
Polymeric stent and/or the arrangement of chamber hole shape space original porous are different, be closely coated in top layer and identical porous arrangement is presented；Compared with
Good person, the present embodiment is attached after oxyhydrogen-base apatite/PVA slurries with the polymeric stent, is so that the polymeric stent surface
And its foregoing slurry is coated with the shape space of chamber hole, and in the arrangement of porous kenel；
Step d, sintering are removed：High temperature sintering is carried out with air body of heater, 1100~1300 DEG C of high temperature sintering temperature, and by height
Molecular scaffold is removed with adhesive, and then obtains the degradable biological material support of porous arrangement, joins Fig. 2 in detail；And
Step e, filling are around knot：It is stent model (support using the biological material support of porous, degradable
Mountingmodel metal-powder) is inserted, the wherein stent model of the degradable biological material support can be in intercommunicating pore solid knot
Structure, and the line footpath structure width of the stent model of the degradable biological material support is 10 μm~200 μm, and metal-powder may be selected from
Titanium, titanium alloy, zirconium, zircaloy, tantalum, the one of tantalum alloy or the one that can be prepared in thermal sintering mode are mixed above, and gold
Belong to its homogeneous metal ball body structure size of presentation after powder sintering, and be equal to un-sintered preceding metal-powder particle diameter, and metal powder
Body particle diameter is between 10 μm~100 μm；After metal-powder inserts the polymeric stent, vacuum high-temperature sintering is carried out therewith,
Vacuum high-temperature sintering temperature is controlled in 1100~1300 DEG C compared with family, and the drying and shaping time is 1~3h, to obtain the degradable life
Thing material and metal-powder mutually chimeric intervertebral implant；Preferably, the present embodiment system obtains can be such as Fig. 2 hydroxy phosphorus ash
Monolithic structure (the i.e. porous metals knot of the degradable guiding stock regeneration of a kind of part of drawing that stone is sintered jointly with metal
Structure), the bulk is the intervertebral implant in porous kenel of the present invention.
Thereby, the intervertebral implant that can obtain oxyhydrogen-base apatite/metal block material through above-mentioned preparation method is implanted into people
Body cavity hole come ensure intervertebral implant implantation after bone tissue can gradually grow into chamber hole shape space, wherein oxyhydrogen-base apatite is implanted in
Be in human body the structure of matter in degradable material, oxyhydrogen-base apatite material be determine its biological degradability it is crucial because
Element, the calcium phosphorus ratio (Ca/P) of oxyhydrogen-base apatite is still to keep apatite (apatite) material knot after 1.65~1.75, sintering
Structure, produces bone guided effect during new bone formation, is slowly degraded by the increase of Implantation Time, and it is degraded at a slow speed
During, can using the outstanding bone guided effect of oxyhydrogen-base apatite, guiding new bone tissue from host bone along oxyhydrogen-base apatite/
The intervertebral implant of metal block material enters inside the intervertebral implant of oxyhydrogen-base apatite/metal block material, reaches top and bottom
The effect of firm healing of bone tissue is with realizing firm be mechanically fixed.
In summary, through foregoing structure design, the present invention can prepare a kind of porous metal structure, and using to constitute
The intervertebral implant of local degradable oxyhydrogen-base apatite/metal block material, the time of human body is implanted into it, makes wherein hydroxy
Apatite structure is progressively degraded, and in degradation process, inducting osseous tissue is sought connections with inside porous metal structure, makes implantation
Portion forms the bone fusion effect on firm top and bottom, makes it further have the work(for changing and increasing easily biological combination
Effect.
A kind of intervertebral implant provided by the present invention, when being compared to each other with foregoing citation case and other located by prior art, more
With following advantages：
The intervertebral implant of the oxyhydrogen-base apatite/metal block material has biodegradability, and intervertebral implant is in bone group
Knitting in forming process to be gradually degraded, and does not influence the 26S Proteasome Structure and Function of newborn osteogenic tissue.
The intervertebral implant of the oxyhydrogen-base apatite/metal block material has plasticity, can be processed to required shape
And with certain mechanical strength, in intervertebral implant after certain time in can still keep its shape, and make what is newly formed
Tissue is with the profile for meeting design.
It is above-listed to describe system's illustrating for one of present invention possible embodiments in detail, only the embodiment and it is not used to limit
The scope of the claims of the present invention is made, it is all without departing from skill spirit equivalence enforcement or change for it of the present invention, it is intended to be limited solely by this case
The scope of the claims in.
In summary, this case not only really category innovation in the kenel of space, and can relatively commonly use article and promote above-mentioned multinomial effect,
The Statutory Invention patent requirement of novelty and progressive should be fully complied with, whence is filed an application in accordance with the law, earnestly asks that your office checks and approves this part
Invention patent application case, to encourage invention, to sense moral just.
Claims (3)
1. a kind of intervertebral implant, it is characterised in that：It is to be collectively formed by metal-powder with degradable biological material；
Wherein, the degradable biological material it is sintered and with plural intercommunicating pore, the metal-powder is then filled in the plural intercommunicating pore
It is interior and sintered and mutually chimeric with the degradable biological material；
The degradable biological material is had by oxyhydrogen-base apatite and the sintered stent model formed of adhesive, the stent model
The plural intercommunicating pore；The line footpath structure width of the stent model is 10 μm~200 μm；
It is presented homogeneous metal ball body structure size after the metal-powder is sintered, and is equal to un-sintered preceding metal-powder particle diameter,
The metal-powder particle diameter is between 10 μm~100 μm.
2. intervertebral implant according to claim 1, it is characterised in that：The metal-powder is selected from titanium, titanium alloy, zirconium, zirconium
At least one of alloy, tantalum and tantalum alloy.
3. a kind of method for preparing intervertebral implant as claimed in claim 1, it is characterised in that：This method comprises the following steps：
Step a, mixing：It is able to will be stirred in the degradable biological material that degradation is produced in human body with adhesive liquid, and
Form a kind of micro- thick liquid；
Step b, it is stained with and covers：Be stained with porous polymeric stent and cover micro- thick liquid so that the polymeric stent surface and/
Or micro- thick liquid is coated with the space of its chamber hole shape；
Step c, drying and shaping：And dried after completion is stained with and covered, micro- thick liquid is closely coated in polymeric stent
Surface and/or chamber hole shape spatially, and arrange different according to polymeric stent surface and/or chamber hole shape space original porous, closely
It is coated in top layer and the porous arrangement of identical is presented；
Step d, sintering are removed：High temperature sintering is carried out with air body of heater, and polymeric stent and adhesive are removed, it is many to obtain
One degradable biological material support of hole arrangement；And
Step e, filling are around knot：It is that stent model inserts metal-powder using the degradable biological material support, and it is high to carry out vacuum
Temperature sintering, to obtain by degradable biological material and metal-powder a mutually chimeric intervertebral implant；The degradable biological material is
Oxyhydrogen-base apatite, the stent model sintered by the oxyhydrogen-base apatite and the adhesive has plural intercommunicating pore, and should
The line footpath structure width of stent model is 10 μm~200 μm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310696169.0A CN104707182B (en) | 2013-12-16 | 2013-12-16 | Intervertebral implant |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310696169.0A CN104707182B (en) | 2013-12-16 | 2013-12-16 | Intervertebral implant |
Publications (2)
| Publication Number | Publication Date |
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| CN104707182A CN104707182A (en) | 2015-06-17 |
| CN104707182B true CN104707182B (en) | 2017-08-11 |
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| CN201310696169.0A Active CN104707182B (en) | 2013-12-16 | 2013-12-16 | Intervertebral implant |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107402373A (en) * | 2016-05-19 | 2017-11-28 | 财团法人金属工业研究发展中心 | Domain type locating module |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100389733C (en) * | 2004-11-29 | 2008-05-28 | 西安理工大学 | Method for preparing hole structure gradient changing spherical inner hole artificial bone |
| WO2008122595A2 (en) * | 2007-04-05 | 2008-10-16 | Cinvention Ag | Biodegradable therapeutic implant for bone or cartilage repair |
| KR101289122B1 (en) * | 2008-03-18 | 2013-07-23 | 한국보건산업진흥원 | COMPLEX IMPLANTS INFILTERATED WITH BIODEGRADABLE Mg(ALLOYS) INSIDE POROUS STRUCTURAL MATERIALS AND METHOD FOR MANUFACTURING THE SAME |
| US8383187B2 (en) * | 2009-02-19 | 2013-02-26 | Depuy Products, Inc. | Rough porous constructs |
| CN103357063B (en) * | 2012-04-10 | 2016-07-06 | 中国科学院金属研究所 | The metallic composite of a kind of bootable osteogenesis and application thereof |
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