CN102293693A - Porous titanium alloy human cervical interbody fusion cage with bioactivity and preparation method thereof - Google Patents
Porous titanium alloy human cervical interbody fusion cage with bioactivity and preparation method thereof Download PDFInfo
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- CN102293693A CN102293693A CN2011101464974A CN201110146497A CN102293693A CN 102293693 A CN102293693 A CN 102293693A CN 2011101464974 A CN2011101464974 A CN 2011101464974A CN 201110146497 A CN201110146497 A CN 201110146497A CN 102293693 A CN102293693 A CN 102293693A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
Abstract
The invention provides a porous titanium alloy human cervical interbody fusion cage with bioactivity and a preparation method thereof. The method comprises the following steps: firstly, inputting model data into electron beam melting equipment according to a design requirement to prepare a porous titanium alloy human cervical interbody fusion cage; secondly, preparing gelatin microspheres; and immersing gelatin microsphere dry powder in an rhBMP-2 solution for gelatin coating modification, preparing a gelatin solution A in double distilled water, immersing the porous titanium alloy human cervical interbody fusion cage in the gelatin solution A, mixing the rhBMP-2 gelatin microspheres and absolute ethanol to obtain suspension B, and immersing the gelatin-coating-modified porous titanium alloy human cervical interbody fusion cage in the suspension B to prepare the porous titanium alloy human cervical interbody fusion cage internally containing an rhBMP-2 sustained-release system. The cervical interbody fusion cage prepared with the method has modulus of elasticity close to that of natural bone tissues, and the porous structure and the bioactivity factor sustained-release system inside the cervical interbody fusion cage can induce growth of new bone tissues, so that the binding problem of bone-material interfaces is solved. Therefore, the cervical interbody fusion cage has better mechanical compatibility and bone integration capability than those of a compact material.
Description
Technical field
The invention belongs to spinal fusion internal fixation field, be specifically related to fusion device and preparation thereof between a kind of porous titanium alloy people cervical vertebra of biologically active.
Background technology
The slippage of cervical vertebra degeneration, intervertebral segmental shakiness and intervertebral disc source property disease etc. are common spinal surgery diseases, have a strong impact on patient's live and work, generally all need carry out fixedly fusion of cervical vertebra to the non-operative treatment nonresponder.The intervertebral fusion operation is generally acknowledged for this class disease better curative effect is arranged.The normal material that adopts of intervertebral fusion mainly contains two classes: 1. bone-grafting material comprises from body bone piece and the transplanting of allograph bone piece; 2. substitution material, i.e. Invasive lumbar fusion device (Interbody Fusion Cage).
Previously normal the employing merely of intervertebral fusion transplanted from body bone piece, but gets bone district complication up to 10%-20% from body, comprises and gets the residual pain in bone district, infection, sensory disturbance etc.Though the allograph bone piece is transplanted and have been avoided getting bone district complication, there are immunological rejection, aids infection virus, cost an arm and a leg, allograph bone is substituted slowly, the little deficiency that waits of area of new bone volume, clinical practice is restricted.(Lelze?EM，Hemmerle?J，Vo?egel?JC，etal.Characterization?and?histological?analyses?of?a?coral-co?llagen?composite?used?for?bone-replacement?graft?material：a?report?of?c?linical?cases.J?Mater?Sci?Mater?Med.1999：10(1)：47-51.)
Adopt simple bone-grafting material to carry out the deficiency of intervertebral fusion for overcoming, fusion device carries out merging between cervical vertebra between clinical main use cervical vertebra at present, mainly comprise: titanium alloy Invasive lumbar fusion device (Titanium Alloys-Cage), polyether-ether-ketone Invasive lumbar fusion device (Poily Ether Ether Ketone-Cage, PEEK-Cage), poly-D, L-lactic acid Invasive lumbar fusion device (Poly-(D, L-Lactide)-Cage, PDLLA-Cage).Compare with simple bone-grafting material, Invasive lumbar fusion device can reduce in the art effectively and post-operative complication, minimizing patient's postoperative pain and quickening patient postoperative function recover.
But still there is certain limitation in traditional Invasive lumbar fusion device: 1. the titanium alloy Invasive lumbar fusion device mainly adopts Ti6Al4V to make, though intensity height, but elastic modelling quantity (110GPa) is higher than nature bone (the about 3-12GPa of cortical bone) far away, the interface problem that has metal-bone, can produce stress shielding, cause bone resorption and that implant takes place is loosening.2. PEEK-Cage elastic modelling quantity and vertebral body cortical bone are approaching, avoided stress shielding, but it and titanium alloy all belong to bio-inert material, osseous tissue can only be attached to material surface and can't enter its inside and reach good bone and integrate, cause bone-material interface bond strength deficiency, take place loosening easily.The surface modification of PEEK-Cage is (as spraying titanium silk, hydroxyapatite (HA) on the surface, utilize the micropore spline structure of coating to induce osseous tissue to grow into) though solved bone-insufficient problem of material interface bond strength to a certain extent, but face coat adds under the load effect at physiological environment, still may be absorbed by body or because stress concentration, interface along porous vesicular surface and ground cracks, and causes to come off.3. PDLLA-Cage has the elastic modelling quantity close with sclerotin, and degradable is the product that can be absorbed by the body, thereby is absorbed gradually and by the surrounding bone tissue substitute, has good biological activity, does not have bone-material interface problem.But its mechanical strength is lower, and it is cracked that the inherent fragility of material itself causes it to be easy in operation technique.And its early stage macromolecules degradation product can cause material proliferation of fibrous tissue on every side, has to a certain degree delayed early stage skeletonization.
In sum, a kind of ideal Invasive lumbar fusion device should possess following characteristics: 1) have excellent biological compatibility; 2) have enough mechanical strengths and anti-fatigue ability; 3) have suitable elastic modelling quantity, be beneficial to bone-material interface mechanics conduction; 4) has certain bone growth inducing etc.In order to reach above requirement, porous titanium alloy material and bio-modification thereof become the focus of research.Porous titanium alloy had both had enough mechanical strengths, had vesicular texture again, and multiple parameters such as shape that can be by control porosity, pore size, hole and distribution effectively reduce the elastic modelling quantity of titanium alloy, realize being complementary with the elastic modelling quantity of natural bone.In hole, add bioactie agent, can induce the osseous tissue hole of growing into as bone morphogenetic protein (BMP) etc., strengthen the machinery locking of porous titanium alloy implant, thereby obtain better extended immobilization effect, so porous titanium alloy is ideal preparation intervertebral fusion modulator material.
Summary of the invention
The object of the present invention is to provide and a kind ofly have enough support strengths to keep disc height and vertebral body stability, can stimulate new bone growth by the induced osteogenesis effect of its inner bioactie agent slow-released system again, integrate fusion device and preparation method thereof between the porous titanium alloy people cervical vertebra of the biologically active of bone fusion between the promotion vertebral body thereby reach good bone.
For achieving the above object, the technical solution used in the present invention is:
1) porous titanium alloy Invasive lumbar fusion device preparation
At first model data is imported in the electron beam melting equipment by the designing requirement of fusion device between the porous titanium alloy people cervical vertebra of required preparation, and in electron beam melting equipment, add the titanium alloy ti6al4v powder, at 600-800 ℃ of electronic beam current with 20-40mA, scanning speed preheating titanium alloy powder with 10000-18000mm/s, then with the electronic beam current of 5-7mA, the scanning speed of 300-500mm/s is the melting titanium alloy powder successively, prepare with required porous titanium alloy people cervical vertebra between the consistent porous titanium alloy people Invasive lumbar fusion device of fusion device shape, it is characterized in that: the peripheral part (1) of fusion device has regular hole between this bioactivity, porous titanium alloy people cervical vertebra, average pore size 300-400 μ m, porosity 40-50%; Central part (2) has the irregular hole of bone trabecula sample, average pore size 400-1000 μ m, and porosity 60-80%,
2) the bioactie agent slow-released system makes up
2.1 be loaded with the preparation of rhBMP-2's (rhBMP-2) gelatine microsphere
2.1.1 the preparation of gelatine microsphere
Pharmagel is dissolved in 40-60 ℃ the distilled water ultrasonic discrete that mass concentration is the gelatin solution of 5%-15%, at 40-60 ℃ gelatin solution is mixed with the volume ratio of liquid paraffin by 1: 5, the emulsifying agent Span-80 that adds gelatin solution and paraffin mixed liquor cumulative volume 2% simultaneously stirs and makes suspension, suspension is cooled to 0 ℃ rapidly also to be continued to stir 20 minutes, under agitation adding the 3-6ml mass concentration by every 1g gelatin in suspension is that 1% genipin precuring stops after 1 hour stirring, dewater with acetone repeatedly, thoroughly washing paraffin final vacuum pump off with absolute ether drains, and then to add the 3-6ml mass concentration by every 1g gelatin be that 1% genipin room temperature lucifuge leaves standstill and solidified 24 hours, sieve with vacuum drying under the room temperature behind the residual genipin of the thorough cleaning of dehydrated alcohol
60Get gelatine microsphere behind the Co radiation sterilization;
2.1.2 gelatine microsphere loads rhBMP-2
At first utilize the rhBMP-2 solution of PBS (PH=6.0) preparation 100-300ng/ml, ratio according to the every 1.0mg gelatine microsphere of 100 μ l rhBMP-2 dry powder, gelatine microsphere dry powder is soaked in the rhBMP-2 solution, and 37 ℃ of shaking tables are hatched, and spend the night, the PBS flushing, centrifugal 10 minutes of 2500rmp cleans gelatine microsphere 2 times, collects the rhBMP-2 gelatine microsphere, the negative pressure lyophilizing
60Seal lucifuge-80 ℃ preservation behind the Co radiation sterilization;
2.2.rhBMP-2/ gelatine microsphere combines with the porous titanium alloy internal void
2.2.1 the gelatin coating of porous titanium alloy is modified
The preparation mass concentration is the gelatin solution A of 5-10% in 50 ℃ distilled water, to immerse in the NaOH solution of 0.5mol/L after the ultrasonic cleaning of porous titanium alloy people Invasive lumbar fusion device elder generation, PBS cleans 3 times, immerse then among the gelatin solution A and under negative pressure, handled 10 minutes, soak after 30 minutes, take out in the baking box that material is placed on 50 ℃ and dry;
2.2.2rhBMP-2/ the porous titanium alloy internal void after gelatine microsphere and gelatin are modified combines
RhBMP-2 gelatine microsphere and dehydrated alcohol are prepared dehydrated alcohol suspension B according to 30mg/ml, ultrasonic discrete 2 hours down, porous titanium alloy people Invasive lumbar fusion device after gelatin coating modified immersed among the suspension B 24 hours, under-93.3kPa negative pressure, and the evacuation lyophilizing.
60The Co radiation sterilization obtains the porous titanium alloy people Invasive lumbar fusion device that the rhBMP-2 slow-released system is contained in inside.
The peripheral part of the Invasive lumbar fusion device of making by preparation method of the present invention has regular hole, average pore size 300-400 μ m, porosity 40-50%; Central part has the irregular hole of bone trabecula sample, average pore size 400-1000 μ m, and porosity 60-80%, and in the hole of peripheral part and central part, be attached with the rhBMP-2/ gelatine microsphere.
The Invasive lumbar fusion device that preparation method of the present invention is made has with natural bone organizes close elastic modelling quantity, loose structure allows the transmission and the freshman bone tissue of body fluid to grow into, solved bone-material interface in conjunction with problem, had than better mechanical compatibility of dense material and bone integration ability.The small-bore design of its peripheral part makes it have higher intensity, and regular porous structure stress is even, can reduce material fragility, is convenient to operation technique.Central part has the irregular pore structure that approaches the bone trabecula tissue, and has bigger aperture and porosity, and the more bone space of growing into is provided, and is beneficial to that nutrient substance enters and metabolic waste is got rid of.RhBMP-2 gelatine microsphere slow-released system by diffusion, carrier progressively decompose or dissolving realizes controlled, stable release, thereby can bring into play lasting bone inductive effect, promote bone fusion between early stage bone integration and vertebral body, reach interpyramidal long-term stability.In addition,, make bone inductive effect mainly occur in Invasive lumbar fusion device inside, can prevent fusion device surrounding bone excessive tissue growth compressing vertebral body important structure on every side because the medicine carrying gelatine microsphere will mainly be distributed in the bigger central part of hole.
Description of drawings
Fig. 1 is the vertical view of the embodiment of the invention;
Fig. 2 is the side sectional view of Fig. 1;
Fig. 3 is the front view of Fig. 1;
Fig. 4 is a sketch map behind the compound rhBMP-2 gelatine microsphere.
The specific embodiment
Below in conjunction with accompanying drawing the present invention is described in further detail.
1) porous titanium alloy Invasive lumbar fusion device preparation
At first model data is imported in the electron beam melting equipment by the designing requirement of fusion device between the porous titanium alloy people cervical vertebra of required preparation, and in electron beam melting equipment, add the titanium alloy ti6al4v powder, at 600-800 ℃ of electronic beam current with 20-40mA, scanning speed preheating titanium alloy powder with 10000-18000mm/s, then with the electronic beam current of 5-7mA, the scanning speed of 300-500mm/s is the melting titanium alloy powder successively, prepare with required porous titanium alloy people cervical vertebra between the consistent porous titanium alloy people Invasive lumbar fusion device of fusion device shape;
Present embodiment is as Fig. 1, Fig. 2, and wedge shape Invasive lumbar fusion device shown in Figure 3, specification is: long (L): 16mm, wide (W): 13mm, high (H): 5/6/7/8mm, wedge angle (angle shown in a): 17 °.Its cross section is similar to the vertebral body cross section, and wedge-shaped design is convenient in the art it be implanted in the intervertebral space.Upper surface is the inclined-plane of 3-4 ° (angle shown in the b), is beneficial to keep the cervical vertebrae physiological bending.It is 3mm that there are 2 diameters the front portion, and the degree of depth is the aperture 3 of 5mm, is used for the clamping Invasive lumbar fusion device, and pitch of holes (d) is 8mm.Peripheral part 1 thickness (D) is 2mm, has regular hole, average pore size 300-400 μ m, porosity 40-50%; Central part 2 has the irregular hole of bone trabecula sample, average pore size 400-1000 μ m, porosity 60-80%.
2) the bioactie agent slow-released system makes up
2.1 be loaded with the preparation of rhBMP-2's (rhBMP-2) gelatine microsphere
2.1.1 the preparation of gelatine microsphere
Pharmagel is dissolved in 40-60 ℃ the distilled water ultrasonic discrete that mass concentration is the gelatin solution of 5%-15%, at 40-60 ℃ gelatin solution is mixed with the volume ratio of liquid paraffin by 1: 5, the emulsifying agent Span-80 that adds gelatin solution and paraffin mixed liquor cumulative volume 2% simultaneously stirs and makes suspension, suspension is cooled to 0 ℃ rapidly also to be continued to stir 20 minutes, under agitation adding the 3-6ml mass concentration by every 1g gelatin in suspension is that 1% genipin precuring stops after 1 hour stirring, dewater with acetone repeatedly, thoroughly washing paraffin final vacuum pump off with absolute ether drains, and then to add the 3-6ml mass concentration by every 1g gelatin be that 1% genipin room temperature lucifuge leaves standstill and solidified 24 hours, sieve with vacuum drying under the room temperature behind the residual genipin of the thorough cleaning of dehydrated alcohol
60Get gelatine microsphere behind the Co radiation sterilization;
2.1.2 gelatine microsphere loads rhBMP-2
At first utilize the rhBMP-2 solution of PBS (PH=6.0) preparation 100-300ng/ml, ratio according to the every 1.0mg gelatine microsphere of 100 μ l rhBMP-2 dry powder, gelatine microsphere dry powder is soaked in the rhBMP-2 solution, and 37 ℃ of shaking tables are hatched, and spend the night, the PBS flushing, centrifugal 10 minutes of 2500rmp cleans gelatine microsphere 2 times, collects the rhBMP-2 gelatine microsphere, the negative pressure lyophilizing
60Seal lucifuge-80 ℃ preservation behind the Co radiation sterilization;
2.2.rhBMP-2/ gelatine microsphere combines with the porous titanium alloy internal void
2.2.1 the gelatin coating of porous titanium alloy is modified
The preparation mass concentration is the gelatin solution A of 5-10% in 50 ℃ distilled water, to immerse in the NaOH solution of 0.5mol/L after the ultrasonic cleaning of porous titanium alloy people Invasive lumbar fusion device elder generation, PBS cleans 3 times, immerse then among the gelatin solution A and under negative pressure, handled 10 minutes, soak after 30 minutes, take out in the baking box that material is placed on 50 ℃ and dry;
2.2.2rhBMP-2/ the porous titanium alloy internal void after gelatine microsphere and gelatin are modified combine rhBMP-2 gelatine microsphere and dehydrated alcohol are prepared dehydrated alcohol suspension B according to 30mg/ml, ultrasonic discrete 2 hours down, porous titanium alloy people Invasive lumbar fusion device after gelatin coating modified immersed among the suspension B 24 hours, under-93.3kPa negative pressure, the evacuation lyophilizing.
60The Co radiation sterilization obtains the porous titanium alloy people Invasive lumbar fusion device that the rhBMP-2 slow-released system is contained in inside.Sketch map is seen Fig. 4 behind the compound rhBMP-2 gelatine microsphere of loose structure.
RhBMP-2 (rhBMP-2) slow-released system that the bioactie agent slow-released system of porous titanium alloy fusion device of the present invention adopts the gelatine microsphere slow release method to set up.Earlier make gelatin form small chondritic about diameter 10-30 μ m, and make rhBMP-2 be dispersed in gelatine microsphere inside, make up the medicine carrying gelatine microsphere by improved emulsifying condensation method.It is compound to adopt the disperse method will be loaded with gelatine microsphere and the embedded material of rhBMP-2 again, and gelatine microsphere is attached among the material hole, makes up the rhBMP-2 slow-released system.The distribution of medicine carrying gelatine microsphere in porous material is relevant with material aperture and porosity, and the big more recombination rate of material aperture and porosity is high more, so gelatine microsphere will mainly be distributed in the central part of Invasive lumbar fusion device.Gelatin is the main organic principle of osseous tissue---the hydrolyzate of collagen, and it can refine obtain through hydrolysis from animal collagen, and cheap and easy to get, no antigen, coefficient of friction are low, biodegradable, safe in utilization effectively.RhBMP-2 then has stronger induced osteogenesis effect, uses in clinical acquisition, and it can significantly promote immature osteoblast and bone precursor (MSC) to change to sophisticated osteocyte, has very strong dystopy, original position osteogenic ability.Metal composite rhBMP-2, no matter external for osteoblastic growth, still, all have tangible bone inductive effect in vivo for the formation of freshman bone tissue.(Herford?AS.rhBMP-2?as?an?option?for?reconstructing?mandibular?continuity?defects.J?Oral?Maxillofac?Surg.2009?Dec；67(12)：2679-84.)
Claims (2)
1. the preparation method of fusion device between a biologically active porous titanium alloy people cervical vertebra is characterized in that:
1) porous titanium alloy Invasive lumbar fusion device preparation
At first model data is imported in the electron beam melting equipment by the designing requirement of fusion device between the porous titanium alloy people cervical vertebra of required preparation, and in electron beam melting equipment, add the titanium alloy ti6al4v powder, at 600-800 ℃ of electronic beam current with 20-40mA, scanning speed preheating titanium alloy powder with 10000-18000mm/s, then with the electronic beam current of 5-7mA, the scanning speed of 300-500mm/s is the melting titanium alloy powder successively, prepare with required porous titanium alloy people cervical vertebra between the consistent porous titanium alloy people Invasive lumbar fusion device of fusion device shape;
2) the bioactie agent slow-released system makes up
2.1 be loaded with the preparation of rhBMP-2's (rhBMP-2) gelatine microsphere
2.1.1 the preparation of gelatine microsphere
Pharmagel is dissolved in 40-60 ℃ the distilled water ultrasonic discrete that mass concentration is the gelatin solution of 5%-15%, at 40-60 ℃ gelatin solution is mixed with the volume ratio of liquid paraffin by 1: 5, the emulsifying agent Span-80 that adds gelatin solution and paraffin mixed liquor cumulative volume 2% simultaneously stirs and makes suspension, suspension is cooled to 0 ℃ rapidly also to be continued to stir 20 minutes, under agitation adding the 3-6ml mass concentration by every 1g gelatin in suspension is that 1% genipin precuring stops after 1 hour stirring, dewater with acetone repeatedly, thoroughly washing paraffin final vacuum pump off with absolute ether drains, and then to add the 3-6ml mass concentration by every 1g gelatin be that 1% genipin room temperature lucifuge leaves standstill and solidified 24 hours, sieve with vacuum drying under the room temperature behind the residual genipin of the thorough cleaning of dehydrated alcohol
60Get gelatine microsphere behind the Co radiation sterilization;
2.1.2 gelatine microsphere loads rhBMP-2
At first utilize the rhBMP-2 solution of PBS (PH=6.0) preparation 100-300ng/ml, ratio according to the every 1.0mg gelatine microsphere of 100 μ l rhBMP-2 dry powder, gelatine microsphere dry powder is soaked in the rhBMP-2 solution, and 37 ℃ of shaking tables are hatched, and spend the night, the PBS flushing, centrifugal 10 minutes of 2500rmp cleans gelatine microsphere 2 times, collects the rhBMP-2 gelatine microsphere, the negative pressure lyophilizing
60Seal lucifuge-80 ℃ preservation behind the Co radiation sterilization;
2.2.rhBMP-2/ gelatine microsphere combines with the porous titanium alloy internal void
2.2.1 the gelatin coating of porous titanium alloy is modified
The preparation mass concentration is the gelatin solution A of 5-10% in 50 ℃ distilled water, to immerse in the NaOH solution of 0.5mol/L after the ultrasonic cleaning of porous titanium alloy people Invasive lumbar fusion device elder generation, PBS cleans 3 times, immerse then among the gelatin solution A and under negative pressure, handled 10 minutes, soak after 30 minutes, take out in the baking box that material is placed on 50 ℃ and dry;
2.2.2rhBMP-2/ the porous titanium alloy internal void after gelatine microsphere and gelatin are modified combines
RhBMP-2 gelatine microsphere and dehydrated alcohol are prepared dehydrated alcohol suspension B according to 30mg/ml, ultrasonic discrete 2 hours down, porous titanium alloy people Invasive lumbar fusion device after gelatin coating modified immersed among the suspension B 24 hours, under-93.3kPa negative pressure, and the evacuation lyophilizing.
60The Co radiation sterilization obtains the porous titanium alloy people Invasive lumbar fusion device that the rhBMP-2 slow-released system is contained in inside.
2. fusion device between the bioactivity, porous titanium alloy people cervical vertebra that the preparation method of fusion device is made between a biologically active porous titanium alloy people cervical vertebra as claimed in claim 1, it is characterized in that: the peripheral part (1) of fusion device has regular hole between this bioactivity, porous titanium alloy people cervical vertebra, average pore size 300-400 μ m, porosity 40-50%; Central part (2) has the irregular hole of bone trabecula sample, average pore size 400-1000 μ m, and porosity 60-80%, and in the hole of peripheral part (1) and central part (2), be attached with the rhBMP-2/ gelatine microsphere.
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