CN108670505A - A kind of Invasive lumbar fusion device of 3D printing and preparation method thereof - Google Patents
A kind of Invasive lumbar fusion device of 3D printing and preparation method thereof Download PDFInfo
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- CN108670505A CN108670505A CN201810492914.2A CN201810492914A CN108670505A CN 108670505 A CN108670505 A CN 108670505A CN 201810492914 A CN201810492914 A CN 201810492914A CN 108670505 A CN108670505 A CN 108670505A
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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
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
-
- 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
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/10—Ceramics or glasses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/222—Gelatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y70/00—Materials specially adapted for additive manufacturing
-
- 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
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
-
- 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
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
The invention discloses a kind of Invasive lumbar fusion devices of 3D printing and preparation method thereof.It is basic raw material, using the mixture of degradable high polymer material and osteogenic activity powder as auxiliary material that the Invasive lumbar fusion device, which is using poly(aryl ether ketone) series material, it is made by double nozzle extruded type 3D printing techniques, the Invasive lumbar fusion device has hollow three-dimensional communication structure, wherein the volume ratio of the basic material and the auxiliary material is 1:0.01~1:1.The microenvironment that the Invasive lumbar fusion device surface of the present invention has cell recognition site, is suitble to cell adhesion and new bone apposition, to improve the binding ability between Invasive lumbar fusion device and new bone；And with the degradation of degradable high polymer material, the spatial position of porous structure can be formed, be conducive to new bone and gradually grow into so that realizes and combine closely between Invasive lumbar fusion device and bone tissue, will not occur to loosen, shift.
Description
Technical field
The present invention relates to field of biomedicine technology, more particularly, to the Invasive lumbar fusion device and its system of a kind of 3D printing
Preparation Method.
Background technology
Currently, China human mortality aging is gradually deepened, caused vertebra degenerative disease perplexs as today's society
The common disease and frequently-occurring disease of the mankind.Vertebra retrogression pathological changes cause disc herniation, centrum segment unstability, spur to form generation god
Through root pressure symptom etc., the work and life of patient are seriously affected, once drug and physics expectant treatment are invalid, often final choosing
Select operative treatment.The marrow of modern spinal surgery is classified as four parts by many scholars：Decompression merges, is orthopedic, interior fixation.Intervertebral
Fusion merges the effective means that internal fixation is the such illness of modern clinical treatment.Interbody fusion often plucks pathological interspinal disk
It removes, bone grafting fusion is carried out to upper and lower two centrums, upper and lower two segments reach after synostosis, you can release lesion and brought
Spinal instability, pain the problems such as.From Invasive lumbar fusion device（cage）For spinal fusion and it is successful since, it is various types of
Cage comes out one after another, and is widely received by clinic.
Invasive lumbar fusion device has the function of support, equal separate loading etc., can preferably restore the physiology of disc height and backbone
Curvature, while autologous bone, allograph bone, the artificial bone etc. being implanted into cage can make hypocentrum realize good Bony union.
The most Invasive lumbar fusion device of clinical research at present includes biological species, metal class, macromolecule polymeric material class.Autologous bone bone grafting merges
For the modus operandi that syncretizing effect is best, plant bone mass is often derived from autologous ilium and decompression is stung except positions such as vertebral plate, articular process, spinous process
The broken bone obtained.Autologous bone transplanting can promote intervertenral space rapid fusion, but increase for bone area pain, the complication such as lose blood, infect
Incidence, while simple bone block implantation intervertenral space rear stability is poor is easily skidded off into canalis spinalis pressuring nerve, clinical application by
To limitation.Allogeneic femur ring（FRA）It is formed by femoral cut, because that can reduce, to take bone to bring concurrent self when applying in early days
Disease and succeed.The pressure that the femur ring can bear is directly related with femur cortex thickness, and spread the disease because it exists,
Insufficient with soleplate contact area and be displaced equivalent risk, application clinically in recent years is restricted.Metal class intervertebral fusion
Device is the Invasive lumbar fusion device truly to come out at first, including the stainless steel of early application and is applied now more
Titanium alloy material.Titanium alloy Invasive lumbar fusion device has preferable biocompatibility and support strength, but exists in clinical application
The excessively high problem of elasticity modulus has compressing centrum to lead to the possibility for shifting or falling off；And titanium alloy material cannot be penetrated through X
Line, the case where bone fusion in later stage intervertenral space can not be implanted into from X-ray film.Common non-metal kind fusion device is polyethers ether
Ketone（PEEK）Material.PEEK is most applied at present with becoming the advantages that its excellent wearability, biocompatibility, chemical stability
The artificial bone matrix composite of foreground, medical PEEK polymer have been designated as " best long-term bone collection PEEK "
（PEEK-Optima LT）.The Young's modulus of pure PEEK and people's bone is closest, it is possible to prevente effectively from implantation human body after with people's bone
The stress shielding and loose phenomenon of generation.PEEK has good material traceability, can pass through X-ray, is seen convenient for postoperative X line
Examine fusion situation.
PEEK fusion devices were applied to clinic in 1997, and preferable clinical effectiveness is achieved in application for many years.
Chou et al. has carried out 27 titanium alloy fusion device implantation, 19 autologous bone transplantings, 9 PEEK fusion devices plants through anterior cervical vertebrae
Enter, and carry out follow-up in 1 year by a definite date to patient, research finds that Cervical Fusion rate is respectively 46.51%, 100%, 100%, complication
Rate is respectively 40.7%, 52.6%, 11.1%, should be research shows that PEEK fusion devices implantation effect is optimal（Chou YC, Chen DC,
Hsieh WA, et al. Efficacy of anterior cervical fusion: comparison of titanium
cages, polyetheretherketone (PEEK) cages and autogenous bone grafts. Journal
of Clinical Neuroscience, 2008, 15(11):1240-1245）.Song Huan a beautiful gems et al. are by anterior cervical decompression PEEK
Fusion device is implanted into 37 patient's bodies, and research finds that the intervertenral space Bony union time is that observation finds PEEK after 10-15 weeks, 2 years
The regression incidence of implant and neighbouring section is relatively low, and clinical effectiveness is satisfied（Song Huanjin, Chen Fuchun, Lin Lei, etc.；Throat
Road PEEK Invasive lumbar fusion devices treatment single gap 37 reports of cervical spondylosis；Mountain Western Medicine S University's journal, 2013,44 (10):821-
823）.PEEK fusion device good mechanical properties, but since it is bio-inert material, fusion device can only be leaned on empty after being implanted into intervertenral space
The upper hypocentrum of bone grafting connection of intracavitary, and fusion device itself can not with new bone formation synostosis, easily cause the implantation later stage loosen,
Displacement.It is domestic now mainly to be produced by machining mode with bar, and it is external be much using thermoplastic processing at
The mode of type, the former causes the waste of raw material, the latter's moulding process to be limited by mold, be not easy to carry out the improvement in structure
And it is realized according to patient profiles personalized.
Existing fusion device itself can not be with new bone formation synostosis, the problem of easily causing the loosening of implantation later stage, shift.It passes
System moulding process can not be modified material in forming process to realize the promotion of its biology performance.
Invention content
The present invention is the defect overcome described in the above-mentioned prior art, provides a kind of Invasive lumbar fusion device of 3D printing, the vertebra
Between fusion device have good osteogenic activity and the synosteosis performance with upper and lower bone tissue surface, and be implanted into after in use
It can combine closely for a long time with bone tissue, will not occur to loosen, shift.
Another object of the present invention is to provide a kind of preparation methods of the Invasive lumbar fusion device of 3D printing.
In order to solve the above technical problems, the technical solution adopted by the present invention is：
The Invasive lumbar fusion device of a kind of Invasive lumbar fusion device of 3D printing, the 3D printing is former based on poly(aryl ether ketone) series material
Material is made using the mixture of degradable high polymer material and osteogenic activity powder as auxiliary material using 3D printing technique, described
Invasive lumbar fusion device has hollow three-dimensional communication structure.
Using poly(aryl ether ketone)（PAEK）Basic material of the series material as Invasive lumbar fusion device, and use degradable macromolecule
Material and osteogenic activity powder inorganic constituents are as auxiliary material, two kinds of material printing alternates, according to designing set mould early period
Basic material and auxiliary material are regularly printed to designated position by type, are obtained with complex internal and surface texture and three-dimensional
The Invasive lumbar fusion device of interconnected pore.
There is osteogenic activity powder, therefore the Invasive lumbar fusion device surface has cell recognition site, is suitble in auxiliary material
The microenvironment of cell adhesion and new bone apposition promotes its biology to improve the binding ability between Invasive lumbar fusion device and new bone
Learn performance；And as the degradation of degradable high polymer material, new bone are gradually grown into, Invasive lumbar fusion device is tightly combined with bone tissue,
It will not occur to loosen, shift.
In addition, poly(aryl ether ketone) series material has excellent biocompatibility and chemical stability, in conjunction with 3D printing technique
It can realize the production of personalized product；Relative to the machining molding mode of mode and thermoplastic processing, beaten using 3D
The moulding process of print prepares the Invasive lumbar fusion device of PAEK series materials, simplifies technological process, realizes making full use of for raw material,
And easily carry out the improvement in structure.
Preferably, in the Invasive lumbar fusion device, the volume ratio of the basic material and auxiliary material is 1:(0.01 ~ 1),
More preferably 1:(0.1~1).
In Invasive lumbar fusion device, the volume ratio of basic material and auxiliary material can influence the mechanical strength of Invasive lumbar fusion device,
Degradation speed, cell adhesion and new bone formation speed etc..Volume ratio by controlling basic material and auxiliary material is 1:
(0.01 ~ 1), Invasive lumbar fusion device obtained can obtain satisfactory mechanical strength, degradation speed, cell adhesion and new bone
Form speed.The volume ratio of basic material and auxiliary material is 1:(0.1 ~ 1), the mechanical strength of Invasive lumbar fusion device, degradation speed,
Cell adhesion and new bone formation speed are more preferably.
Preferably, the weight ratio of the degradable high polymer material and osteogenic activity powder is 1:(0.001 ~ 1), more preferably
It is 1:(0.1~1).
Bone active powder makes Invasive lumbar fusion device surface have cell recognition site, suitable cell adhesion and new bone apposition
Microenvironment；High molecular material can gradually degrade, and space is provided for new Bone Ingrowth, increase what Invasive lumbar fusion device was combined with bone tissue
Compactness.Weight ratio by controlling degradable high polymer material and osteogenic activity powder is 1:(0.001 ~ 1) can be had
There are suitable degradation speed and enough cell recognition sites, the microenvironment for being suitble to cell adhesion and new bone apposition.Work as degradation
The weight ratio of high molecular material and osteogenic activity powder is 1:(0.1 ~ 1), Invasive lumbar fusion device have more suitable degradation speed
And more born of the same parents' recognition sites, the microenvironment for being suitble to cell adhesion and new bone apposition, be conducive to Invasive lumbar fusion device and bone tissue
In conjunction with even closer, loose shift will not occur.
Preferably, the poly(aryl ether ketone) series material is polyether-ether-ketone（PEEK）, polyether-ketone（PEK）, polyether ketone ketone
（PEKK）, polyether ether ketone ketone（PEEKK）, polyetherketoneetherketoneketone（PEKEKK）One or more of combination.
It is highly preferred that the poly(aryl ether ketone) series material is polyether-ether-ketone and/or polyether ketone ketone.
Using poly(aryl ether ketone)（PAEK）Basic material of the series material as Invasive lumbar fusion device, PAEK series materials have excellent
Good biocompatibility and chemical stability has higher safety after being implanted into human body；PAEK has X-ray transparent, plants
Bone fusion situation can be observed after entering human body by X-ray film；The Young's modulus of PAEK series materials between cancellous bone and cortex bone it
Between, it is possible to prevente effectively from the stress shielding and loose phenomenon that are generated with people's bone after implantation human body.
Preferably, the degradable high polymer material is degradable synthesized polymer material or degradable natural macromolecule material
One kind in material.Preferably, the degradable synthesized polymer material is polycaprolactone, polylactic acid, polyglycolic acid, poly- breast
One or more of acid-co-glycolic acid combines.Preferably, the degradable natural high molecular material is bright
One or more of glue, collagen, agarose combine.
Preferably, the osteogenic activity powder is hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, calcium octahate phosphate, oxidation
Calcium, calcium silicates, calcium sulfate, calcium carbonate, strontium carbonate, strontium phosphate, sodium phosphate, magnesium phosphate, magnesia, silica, trbasic zinc phosphate, oxidation
One or more of zinc, bio-vitric, metal magnesium powder combine.
By the control to material and print conditions, the performance of the Invasive lumbar fusion device can be adjusted.Preferably, institute
It is 5% ~ 70% to state Invasive lumbar fusion device porosity, and Young's modulus is 0.5 Gpa ~ 3.8Gpa.
The present invention protects the preparation method of the Invasive lumbar fusion device of above-mentioned 3D printing, the Invasive lumbar fusion device to pass through double sprays simultaneously
The mode of head extruded type 3D printing, two nozzles print basic material respectively and auxiliary material is made.
Preferably, the preparation method includes the following steps：
S1., basic material, auxiliary material are separately added into the feed bin of the first nozzle, the second nozzle；
S2. the first nozzle and the alternately 3D printing of the second nozzle, obtain Invasive lumbar fusion device formed body；
S3. Invasive lumbar fusion device formed body is post-processed, obtains the Invasive lumbar fusion device.
The alternately 3D printing, including after the first nozzle squeezes out one or more fibers, it is dynamic to temporarily cease printing
Make, then the second nozzle proceeds by printing, after squeezing out one or more fibers, temporarily ceases printing operation, and then first
Nozzle then starts to print, and execution above-mentioned steps are recycled with this, until printing terminates；Alternatively, the first nozzle printing it is complete one layer or
After person's multilayer, printing operation is temporarily ceased, then the second nozzle proceeds by printing, after having printed one layer or multilayer, temporarily
Stop printing operation, subsequent first nozzle then starts to print, and execution above-mentioned steps are recycled with this, until printing terminates.Ability
The technical staff in domain is it is understood that the alternately 3D printing can also be other forms, as long as two nozzles have
Be alternately carried out printing, belong to it is of the present invention within the scope of.
Preferably, the printing type of first nozzle is melting extrusion, and print temperature is 350 ~ 550 DEG C；Described second
The printing type of nozzle is melting extrusion, formed at normal temp, or is slurry extrusion, low temperature moulding, and print temperature is 37 ~ 300 DEG C.
Basic material is printed by the way of melting extrusion.
When degradable high polymer material is degradable synthesized polymer material, degradable synthesized polymer material mixing skeletonization
It is 10 ~ 40 DEG C that can receive temperature by melting extrusion, formed at normal temp, molding room after active powder.
Degradable high polymer material, which can also be, to be dissolved to obtain degradable high polymer material solution by solvent, will be degradable
Macromolecule material solution mixing osteogenic activity powder prepares auxiliary material slurry, is squeezed out in suitable temperature, molding.Degradable high score
A concentration of 0.5wt.% ~ 80wt.% of sub- material solution.Molding temperature is -20 ~ 10 DEG C.Dissolve degradable synthesized polymer material
The selected solvent of material is selected according to the solubility property of synthesis high molecular material, preferably dioxane.Dissolve degradable natural
Solvent selected by high molecular material is preferably deionized water.
Preferably, a diameter of 100 ~ 1500 μm of first nozzle.
It is highly preferred that a diameter of 200 ~ 1000 μm of first nozzle.
Preferably, the granularity of the osteogenic activity powder be 1nm ~ 500 μm, a diameter of the 100 ~ 1500 of second nozzle
μm.The granularity of osteogenic activity powder to mechanical strength, printing precision, can all have an impact to irritation of cell etc., therefore, it is necessary to
Select granularity for the osteogenic activity powder of 1nm ~ 500 μm.The diameter of second nozzle needs the osteogenic activity powder of corresponding selection
Grain size.
It is highly preferred that a diameter of 200 ~ 1000 μm of second nozzle.
Preferably, the post-processing includes that Invasive lumbar fusion device formed body is carried out sterilization treatment.
Degradable high polymer material be degradable synthesized polymer material when, auxiliary material can by melting extrusion, often
After temperature molding, sterilization treatment is carried out, gamma-radiation irradiation may be used in sterilization treatment.
When degradable high polymer material is degradable synthesized polymer material or agarose, auxiliary material slurry extrusion molding
It is positioned in low temperature refrigerator immediately afterwards and is frozen into solid-state, then carry out freeze-drying process, then carry out sterilization treatment.At sterilizing
Gamma-radiation irradiation may be used in reason.
When degradable high polymer material is gelatin or collagen, it is positioned in refrigerator immediately after auxiliary material slurry extrusion molding
Be frozen into solid-state, then carry out freeze-drying process, using crosslinking agent in dry Invasive lumbar fusion device gelatin or collagen into
Row crosslinking Treatment carries out cleaning with deionized water after the completion of crosslinking and removes remaining crosslinking agent, subsequent pre-freeze, frozen dried, so
After carry out sterilization treatment.Gamma-radiation irradiation may be used in sterilization treatment.
Preferably, the time of the crosslinking Treatment be 0.5 ~ for 24 hours.
Preferably, the crosslinking agent includes glutaraldehyde, formaldehyde, glutamine transaminage, Geniposide, carbodiimides.
Preferably, a concentration of wt.% of 0.05 wt.% ~ 2 of the crosslinking agent.
Preferably, the post-processing includes the steps that carrying out the Absorption Growth factor after Invasive lumbar fusion device formed body sterilizes.
Preferably, the growth factor is with facilitating bone and/or at the growth factor of vascular function.Preferably, the growth factor
For bone morphogenetic protein, fibroblast growth factor, insulin-like growth factor, vascular endothelial growth factor, blood platelet
One or more of derived growth factor, transforming growth factor-β combine.
By Invasive lumbar fusion device absorption facilitate bone or at the growth factor of vascular function after, the intervertebral can be further increased
The bone fusion performance of fusion device.
Following method may be used in the step of Absorption Growth factor：By the Invasive lumbar fusion device after sterilizing in 37 DEG C of vacuum conditions
Under be soaked in 12 ~ 48 h in sterile growth factor solution, by way of physical absorption by growth factor be adsorbed in surface and
In internal void.Invasive lumbar fusion device after the Absorption Growth factor, which is placed in refrigerator, is frozen into solid-state, then carries out at freeze-drying
Reason.The concentration of growth factor is generally 0.1 ~ 500ng/mL in growth factor solution.
Preferably, in the growth factor solution growth factor a concentration of 50 ~ 200ng/mL.
Invasive lumbar fusion device of the present invention includes cervical vertebral fusion cage, lumbar fusion cages.
The outer shape of the Invasive lumbar fusion device is unlimited, can be conventional shape or personalized shape.
The conventional shape includes：Circular ring shape, cylinder, banana-shaped, elliptical cylinder-shape, cuboid, polygon.Described
Property shape be it is variously-shaped prepared by patient's actual conditions.
The conventional shape is preferably dimensioned to be：8 ~ 20 mm of width, 10 ~ 36 mm of length, 4 ~ 14 mm of height.It is described
The size of personalized shape is depending on actual conditions.
Compared with prior art, the beneficial effects of the invention are as follows：
The present invention uses basic material of the poly(aryl ether ketone) series material as Invasive lumbar fusion device, and uses degradable high polymer material
It is auxiliary material with osteogenic activity powder, Invasive lumbar fusion device, Invasive lumbar fusion device surface tool obtained is made by 3D printing technique
The microenvironment for having cell recognition site, being suitble to cell adhesion and new bone apposition, to improve between Invasive lumbar fusion device and new bone
Binding ability has good osteogenic activity and the synosteosis performance with upper and lower bone tissue surface；And with degradable macromolecule
The degradation of material, new bone are gradually grown into, and can be combined closely for a long time with bone tissue in use after implantation, and pine will not occur
Dynamic, displacement.
Specific implementation mode
The present invention is further illustrated With reference to embodiment.
Embodiment 1
The present embodiment uses printed material of the PEEK raw materials as the first nozzle, using polycaprolactone and hydroxyapatite mixing material
Expect that the printed material as the second nozzle, two nozzles are all made of melting extrusion mode 3D printing lumbar fusion cages.
Polycaprolactone is dissolved in dioxane solvent, and the hydroxylapatite powder that granularity is 10 ~ 100 μm is added thereto
Body, freeze-drying removal dioxane, obtains the mixture of polycaprolactone and hydroxyapatite after stirring evenly, wherein gathering in oneself
The mass ratio of ester and hydroxyapatite is 1:1.PEEK is added to the feed bin of the first nozzle, is warming up to 380 DEG C to PEEK meltings；It will
The feed bin of the second nozzle is added in the mixture of polycaprolactone and hydroxyapatite, is warming up to 220 DEG C to mixture melting.Molding room
The temperature remains within the normal range for temperature, carries out printing alternate according to set structure, the length of 36mm, width 20mm, high 12mm are grown into final printing
Cube shape lumbar fusion cages.That prepares 200ng/mL contains bone morphogenesis protein-2（BMP-2）Sterile solution, by above-mentioned use
Treated that lumbar fusion cages are dipped into the solution for gamma-radiation irradiation sterilization, and the growth is soaked under 37 DEG C of vacuum conditions
12 h in factor solutions.Taking-up is placed in -20 DEG C of refrigerators and carries out freeze-drying process after freezing 1h.Final Lumbar Fusion obtained
In device, PEEK is 1 with the volume ratio of polycaprolactone and hydroxyapatite mixture:0.5, porosity 10%, Young's modulus is
3.5GPa。
Biological assessment
Select preparation process, the proportioning of basic material and auxiliary material, print parameters, sample size ginseng similarly to Example 1
Auxiliary material in second nozzle is changed to pure polycaprolactone by number, aftertreatment technology, is prepared the lumbar vertebrae without hydroxyapatite and is melted
Clutch.Using this fusion device as the comparative example of embodiment 1.
Sample in embodiment 1 and comparative example is subjected to gamma-radiation irradiation sterilization processing, is then carried out with sterile sampling
Cell experiment, verification cell in the sticking of sample surfaces, be proliferated and extracellular matrix calcium phosphorus precipitation.
Stick experiment：It is inoculated with osteoblast MC3T3-E1 to sample surfaces, cell inoculation is taken out sample and consolidated afterwards for 24 hours
Fixed, dehydration, frozen dried, then observe cellular morphology with SEM.The result shows that the cell of 1 sample surfaces of embodiment has more preferably
Sprawl form and adherence rate.
Proliferation experiment：To after sample surfaces inoculation osteoblast MC3T3-E1, cell inoculation 1d/3d/7d, tried with CCK-8
Agent box detects cell activity, the results showed that, the cell of 1 sample surfaces of embodiment has faster multiplication rate.
Extracellular matrix calcium phosphorus precipitation is tested：To sample surfaces be inoculated with osteoblast MC3T3-E1, cell inoculation 14d and
After 21d, sample surfaces calcium tubercle is dyed with alizarin red stain, the results showed that have on the cell of 1 sample surfaces of embodiment
With the presence of more red dye calcium tubercles, show there are more calcium phosphorous compounds heavy in the extracellular matrix of 1 sample surfaces of embodiment
Product.
Embodiment 2
The present embodiment uses printed material of the PEEK raw materials as the first nozzle, is made using polylactic acid and bio-vitric mixing material
For the printed material of the second nozzle.First nozzle printed using melting extrusion mode, the second nozzle using solvent dissolving low temperature at
Type mode printing prepares lumbar fusion cages.
Polylactic acid is dissolved in dioxane solvent, and the bio-vitric powder that granularity is 20 ~ 200 nm is added thereto,
Stirring forms uniform slurry.The mass ratio of a concentration of 80 wt.% of polylactic acid in the slurry, polylactic acid and bio-vitric is 1:
0.05。
PEEK is added to the feed bin of the first nozzle, is warming up to 420 DEG C to PEEK meltings；By the slurry of polylactic acid and bio-vitric
The feed bin of the second nozzle is added in body, and the temperature remains within the normal range.It is -10 DEG C that molding room, which receives temperature, according to set structure alternately beat
The nearly oval lumbar fusion cages of 30mm, width 16mm, high 8mm are grown into print, final printing.The lumbar fusion cages are molded postposition
In -20 DEG C of refrigerator pre-freezes, subsequent freeze-drying process.
Preparation contains fibroblast growth factor（FGF）And vascular endothelial growth factor（VEGF）Sterile solution, two
The concentration of kind growth factor is respectively 200ng/mL.With gamma-radiation irradiation sterilization, treated that lumbar fusion cages are dipped by above-mentioned
In the solution, 48h in the growth factor solution is soaked under 37 DEG C of vacuum conditions.Taking-up is placed in -20 DEG C of refrigerators and freezes 1h
After carry out freeze-drying process.In final lumbar fusion cages obtained, the volume of PEEK and polylactic acid and bio-vitric mixture
Than being 1:1, porosity 50%, Young's modulus 1.5GPa.
Biological assessment
Select preparation process, the proportioning of basic material and auxiliary material, print parameters, sample size ginseng similarly to Example 2
Auxiliary material in second nozzle is changed to pure polylactic acid, prepares the Lumbar Fusion without bio-vitric by number, aftertreatment technology
Device.Using this fusion device as the comparative example of embodiment 2.
Sample in embodiment 2 and comparative example is subjected to gamma-radiation irradiation sterilization processing, is then carried out with sterile sampling
Cell experiment, verification cell in the sticking of sample surfaces, be proliferated and extracellular matrix calcium phosphorus precipitation.
Stick experiment：It is inoculated with osteoblast MC3T3-E1 to sample surfaces, cell inoculation is taken out sample and consolidated afterwards for 24 hours
Fixed, dehydration, frozen dried, then observe cellular morphology with SEM.The result shows that the cell of 2 sample surfaces of embodiment has more preferably
Sprawl form and adherence rate.
Proliferation experiment：To after sample surfaces inoculation osteoblast MC3T3-E1, cell inoculation 1d/3d/7d, tried with CCK-8
Agent box detects cell activity, the results showed that, the cell of 2 sample surfaces of embodiment has faster multiplication rate.
Extracellular matrix calcium phosphorus precipitation is tested：To sample surfaces be inoculated with osteoblast MC3T3-E1, cell inoculation 14d and
After 21d, sample surfaces calcium tubercle is dyed with alizarin red stain, the results showed that have on the cell of 2 sample surfaces of embodiment
With the presence of more red dye calcium tubercles, show there are more calcium phosphorous compounds heavy in the extracellular matrix of 2 sample surfaces of embodiment
Product.
Embodiment 3
The present embodiment uses printed material of the PEKK raw materials as the first nozzle, using gelatin and calcium sulfate mixing material as the
The printed material of two nozzles.First nozzle is printed using melting extrusion mode, the second nozzle dissolves low temperature moulding side using solvent
Formula printing prepares cervical vertebral fusion cage.
Gelatin is dissolved in deionized water under the conditions of 40 DEG C, and the sulfuric acid that granularity is 500nm ~ 100 μm is added thereto
Calcium powder body, stirring form uniform slurry.The mass ratio of a concentration of 20 wt.% of gelatin in the slurry, gelatin and calcium sulfate is
1: 5。
PEKK is added to the feed bin of the first nozzle, is warming up to 500 DEG C to PEKK meltings；The slurry of gelatin and calcium sulfate is added
Enter the feed bin of the second nozzle,
Second nozzle temperature is maintained at 40 DEG C or so.It is 10 DEG C that molding room, which receives temperature, according to set structure alternately beat
Print, the final circular ring shape cervical vertebral fusion cage for printing 16 mm of growth, wide 14 mm, high 6 mm.The cervical vertebral fusion cage molding be placed on-
20 DEG C of refrigerator pre-freezes, subsequent freeze-drying process.Cervical vertebral fusion cage after freeze-drying is soaked in the glutaraldehyde of 0.1 wt.%
Crosslinking 2h is carried out in solution, and the remaining crosslinking agent of removal is cleaned with deionized water after the completion of crosslinking.At subsequent progress pre-freeze, freeze-drying
Reason.
Preparation contains platelet derived growth factor（PDGF）Sterile solution, a concentration of 100ng/ of the growth factor
mL.With gamma-radiation irradiation sterilization, treated that cervical vertebral fusion cage is dipped into the solution by above-mentioned, is soaked under 37 DEG C of vacuum conditions
It steeps in the growth factor solution for 24 hours.Taking-up is placed in -20 DEG C of refrigerators and carries out freeze-drying process after freezing 2h.It is final to be made
Cervical vertebral fusion cage in, the volume ratio of PEKK and gelatin and mixture of calcium sulfate is 1:0.1, porosity 20%, Young's modulus is
3GPa。
Biological assessment
Select preparation process, the proportioning of basic material and auxiliary material, print parameters, sample size ginseng similarly to Example 3
Auxiliary material in second nozzle is changed to pure gelatin, prepares the cervical vertebral fusion cage without calcium sulfate by number, aftertreatment technology.With
Comparative example of this fusion device as embodiment 3.
Sample in embodiment 3 and comparative example is subjected to gamma-radiation irradiation sterilization processing, is then carried out with sterile sampling
Cell experiment, verification cell in the sticking of sample surfaces, be proliferated and extracellular matrix calcium phosphorus precipitation.
Stick experiment：It is inoculated with osteoblast MC3T3-E1 to sample surfaces, cell inoculation is taken out sample and consolidated afterwards for 24 hours
Fixed, dehydration, frozen dried, then observe cellular morphology with SEM.The result shows that the cell of 3 sample surfaces of embodiment has more preferably
Sprawl form and adherence rate.
Proliferation experiment：To after sample surfaces inoculation osteoblast MC3T3-E1, cell inoculation 1d/3d/7d, tried with CCK-8
Agent box detects cell activity, the results showed that, the cell of 3 sample surfaces of embodiment has faster multiplication rate.
Extracellular matrix calcium phosphorus precipitation is tested：To sample surfaces be inoculated with osteoblast MC3T3-E1, cell inoculation 14d and
After 21d, sample surfaces calcium tubercle is dyed with alizarin red stain, the results showed that have on the cell of 3 sample surfaces of embodiment
With the presence of more red dye calcium tubercles, show there are more calcium phosphorous compounds heavy in the extracellular matrix of 3 sample surfaces of embodiment
Product.
Embodiment 4
The present embodiment uses printed material of the PEKK raw materials as the first nozzle, using agarose and calcium carbonate mixing material conduct
The printed material of second nozzle.First nozzle is printed using melting extrusion mode, the second nozzle dissolves low temperature moulding using solvent
Mode printing prepares cervical vertebral fusion cage.
Agarose is dissolved in deionized water under the conditions of 90 DEG C, and the calcium carbonate that granularity is 10nm-1 μm is added thereto
Powder, stirring form uniform slurry.The mass ratio of a concentration of 3 wt.% of agarose in the slurry, agarose and calcium carbonate is
1: 10。
PEKK is added to the feed bin of the first nozzle, is warming up to 480 DEG C to PEKK meltings；By the slurry of agarose and calcium carbonate
The feed bin of the second nozzle is added, the second nozzle temperature is warming up to 90 DEG C or so.It is 5 DEG C that molding room, which receives temperature, according to set
Structure carries out printing alternate, the final square bodily form cervical vertebral fusion cage for printing 12 mm of growth, wide 12 mm, high 8 mm.The cervical vertebra
Fusion device molding is placed on -20 DEG C of refrigerator pre-freezes, subsequent freeze-drying process.
Preparation contains insulin-like growth factor（IGF）Sterile solution, a concentration of 500ng/mL of the growth factor.It will
Above-mentioned with gamma-radiation irradiation sterilization, treated that cervical vertebral fusion cage is dipped into the solution, is soaked under 37 DEG C of vacuum conditions
48h in the growth factor solution.Taking-up is placed in -20 DEG C of refrigerators and carries out freeze-drying process after freezing 2h.Final neck obtained
In vertebra fusion device, PEKK is 1 with the volume ratio of agarose and calcium carbonate mixture:0.7, porosity 60%, Young's modulus is
1GPa。
Biological assessment
Select preparation process, the proportioning of basic material and auxiliary material, print parameters, sample size ginseng similarly to Example 4
Auxiliary material in second nozzle is changed to pure agarose, prepares cervical vertebral fusion cage not calciferous by number, aftertreatment technology.
Using this fusion device as the comparative example of the present embodiment 4.
Sample in embodiment 4 and comparative example is subjected to gamma-radiation irradiation sterilization processing, is then carried out with sterile sampling
Cell experiment, verification cell in the sticking of sample surfaces, be proliferated and extracellular matrix calcium phosphorus precipitation.
Stick experiment：It is inoculated with osteoblast MC3T3-E1 to sample surfaces, cell inoculation is taken out sample and consolidated afterwards for 24 hours
Fixed, dehydration, frozen dried, then observe cellular morphology with SEM.The result shows that the cell of 4 sample surfaces of embodiment has more preferably
Sprawl form and adherence rate.
Proliferation experiment：To after sample surfaces inoculation osteoblast MC3T3-E1, cell inoculation 1d/3d/7d, tried with CCK-8
Agent box detects cell activity, the results showed that, the cell of 4 sample surfaces of embodiment has faster multiplication rate.
Extracellular matrix calcium phosphorus precipitation is tested：To sample surfaces be inoculated with osteoblast MC3T3-E1, cell inoculation 14d and
After 21d, sample surfaces calcium tubercle is dyed with alizarin red stain, the results showed that have on the cell of 4 sample surfaces of embodiment
With the presence of more red dye calcium tubercles, show there are more calcium phosphorous compounds heavy in the extracellular matrix of 4 sample surfaces of embodiment
Product.
Obviously, the above embodiment of the present invention be only to clearly illustrate example of the present invention, and not be pair
The restriction of embodiments of the present invention.For those of ordinary skill in the art, may be used also on the basis of the above description
To make other variations or changes in different ways.There is no necessity and possibility to exhaust all the enbodiments.It is all this
All any modification, equivalent and improvement etc., should be included in the claims in the present invention made by within the spirit and principle of invention
Protection domain within.
Claims (12)
1. a kind of Invasive lumbar fusion device of 3D printing, which is characterized in that the Invasive lumbar fusion device of the 3D printing is with poly(aryl ether ketone) series
Material is basic raw material, using the mixture of degradable high polymer material and osteogenic activity powder as auxiliary material, using 3D printing
Technology is made, and the Invasive lumbar fusion device has hollow three-dimensional communication structure.
2. the Invasive lumbar fusion device of 3D printing according to claim 1, which is characterized in that described in the Invasive lumbar fusion device
The volume ratio of basic material and the auxiliary material is 1:(0.01 ~ 1), preferred volume ratio 1:（0.1~1）.
3. the Invasive lumbar fusion device of 3D printing according to claim 1, which is characterized in that the degradable high polymer material and institute
The mass ratio for stating osteogenic activity powder is 1:(0.001 ~ 1), preferred mass ratio are 1:(0.1~1).
4. the Invasive lumbar fusion device of 3D printing according to claim 1, which is characterized in that the poly(aryl ether ketone) series material is poly-
One or more of ether ether ketone, polyether-ketone, polyether ketone ketone, polyether ether ketone ketone, polyetherketoneetherketoneketone combine.
5. the Invasive lumbar fusion device of 3D printing according to claim 1, which is characterized in that the degradable high polymer material is can
One kind in degradation synthesis macromolecule or degradable natural macromolecule；Preferably, the degradable synthesized polymer is to gather in oneself
One or more of ester, polylactic acid, polyglycolic acid, Poly(D,L-lactide-co-glycolide combine, the degradable day
Right macromolecule is the combination of one or more of gelatin, collagen, agarose.
6. the Invasive lumbar fusion device of 3D printing according to claim 1, which is characterized in that the osteogenic activity powder includes hydroxyl
Apatite, tricalcium phosphate, tetracalcium phosphate, calcium octahate phosphate, calcium oxide, calcium silicates, calcium sulfate, calcium carbonate, strontium carbonate, strontium phosphate,
One or more of sodium phosphate, magnesium phosphate, magnesia, silica, trbasic zinc phosphate, zinc oxide, bio-vitric, metal magnesium powder
Combination.
7. the Invasive lumbar fusion device of 3D printing according to claim 1, which is characterized in that the porosity of the Invasive lumbar fusion device
It is 5% ~ 70%, Young's modulus is 0.5Gpa ~ 3.8Gpa.
8. a kind of preparation method of the Invasive lumbar fusion device of any one of claim 1 ~ 7 3D printing, which is characterized in that the vertebra
Between fusion device by way of double nozzle extruded type 3D printings, two nozzles print the basic material and auxiliary material system respectively
At.
9. preparation method according to claim 8, which is characterized in that the preparation method includes the following steps：
S1., basic material, auxiliary material are separately added into the feed bin of the first nozzle, the second nozzle；
S2. by the first nozzle and the alternately 3D printing of the second nozzle, Invasive lumbar fusion device formed body is obtained；
S3. the Invasive lumbar fusion device formed body is post-processed, obtains the Invasive lumbar fusion device.
10. preparation method according to claim 9, which is characterized in that the printing type of first nozzle is that melting is squeezed
Go out, print temperature is 350 DEG C ~ 550 DEG C；The printing type of second nozzle is melting extrusion, formed at normal temp, or is slurry
It squeezes out, low temperature moulding, print temperature is 37 DEG C ~ 300 DEG C.
11. preparation method according to claim 9, which is characterized in that the granularity of the osteogenic activity powder is 1nm-
500 μm, 100 μm ~ 1500 μm of the diameter range of second nozzle.
12. preparation method according to claim 9, which is characterized in that the post-processing includes shaping Invasive lumbar fusion device
The step of Absorption Growth factor is carried out after body sterilization treatment；Preferably, the growth factor is with facilitating bone and/or at blood vessel
The growth factor of function；It is further preferred that the growth factor be bone morphogenetic protein, fibroblast growth factor,
One kind in insulin-like growth factor, vascular endothelial growth factor, platelet derived growth factor, transforming growth factor-β or
Two or more combinations.
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109568669A (en) * | 2018-11-30 | 2019-04-05 | 重庆医科大学附属永川医院 | A kind of implantation material and preparation method thereof fixed for backbone reparation |
| CN110193926A (en) * | 2019-05-08 | 2019-09-03 | 西安交通大学 | A kind of design and manufacturing method of the bionical multi-level joint prosthesis of polyether-ether-ketone |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201734802U (en) * | 2010-08-25 | 2011-02-09 | 邓忠良 | Partial absorbable intervertebral fusion apparatus |
| US20140107786A1 (en) * | 2012-10-11 | 2014-04-17 | Rhausler, Inc. | Fusion cage implant with lattice structure |
| CN203953882U (en) * | 2014-03-16 | 2014-11-26 | 广东冠昊生物科技股份有限公司 | Biotype cervical vertebral fusion cage |
| CN105031737A (en) * | 2014-12-03 | 2015-11-11 | 北京印刷学院 | 3D printed digital artificial bone and preparation method thereof |
| CN106580526A (en) * | 2017-01-12 | 2017-04-26 | 上海锐植医疗器械有限公司 | Cervical vertebral fusion cage |
| US20170258606A1 (en) * | 2015-10-21 | 2017-09-14 | Thomas Afzal | 3d printed osteogenesis scaffold |
| CN206792524U (en) * | 2017-01-12 | 2017-12-26 | 上海锐植医疗器械有限公司 | A kind of cervical vertebral fusion cage |
-
2018
- 2018-05-22 CN CN201810492914.2A patent/CN108670505B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201734802U (en) * | 2010-08-25 | 2011-02-09 | 邓忠良 | Partial absorbable intervertebral fusion apparatus |
| US20140107786A1 (en) * | 2012-10-11 | 2014-04-17 | Rhausler, Inc. | Fusion cage implant with lattice structure |
| CN203953882U (en) * | 2014-03-16 | 2014-11-26 | 广东冠昊生物科技股份有限公司 | Biotype cervical vertebral fusion cage |
| CN105031737A (en) * | 2014-12-03 | 2015-11-11 | 北京印刷学院 | 3D printed digital artificial bone and preparation method thereof |
| CN105031737B (en) * | 2014-12-03 | 2018-01-30 | 北京印刷学院 | Digitlization artificial bone of 3D printing and preparation method thereof |
| US20170258606A1 (en) * | 2015-10-21 | 2017-09-14 | Thomas Afzal | 3d printed osteogenesis scaffold |
| CN106580526A (en) * | 2017-01-12 | 2017-04-26 | 上海锐植医疗器械有限公司 | Cervical vertebral fusion cage |
| CN206792524U (en) * | 2017-01-12 | 2017-12-26 | 上海锐植医疗器械有限公司 | A kind of cervical vertebral fusion cage |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109568669A (en) * | 2018-11-30 | 2019-04-05 | 重庆医科大学附属永川医院 | A kind of implantation material and preparation method thereof fixed for backbone reparation |
| CN109568669B (en) * | 2018-11-30 | 2021-05-11 | 重庆医科大学附属永川医院 | Implant material for spinal column repair and fixation and preparation method thereof |
| CN110193926A (en) * | 2019-05-08 | 2019-09-03 | 西安交通大学 | A kind of design and manufacturing method of the bionical multi-level joint prosthesis of polyether-ether-ketone |
| CN110393614A (en) * | 2019-08-10 | 2019-11-01 | 山东百多安医疗器械有限公司 | A kind of porous bionical cervical fusion cage |
| WO2022126426A1 (en) * | 2020-12-16 | 2022-06-23 | 中国科学院深圳先进技术研究院 | Controllable gradient scaffold for loading drug, active factor and cell, 3d printing method therefor, and dedicated multi-nozzle 3d printer thereto |
| CN112691233A (en) * | 2020-12-28 | 2021-04-23 | 南昌大学 | 3D printing interbody fusion cage and preparation method thereof |
| CN114099773A (en) * | 2021-11-30 | 2022-03-01 | 桂林航天工业学院 | Polyether-ether-ketone skeleton support and preparation method thereof |
| CN114099773B (en) * | 2021-11-30 | 2022-07-12 | 桂林航天工业学院 | Polyether-ether-ketone skeleton support and preparation method thereof |
| CN114259604A (en) * | 2021-12-17 | 2022-04-01 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of 3D printing ordered vascularization promoting drug-loaded bone repair scaffold, product and application thereof |
| CN115364277A (en) * | 2022-09-09 | 2022-11-22 | 成都医学院第一附属医院 | Preparation method of composite material for interbody fusion cage |
| CN115531052A (en) * | 2022-10-12 | 2022-12-30 | 北京科技大学 | Degradable interbody fusion cage and additive manufacturing method thereof |
| CN116919679A (en) * | 2023-09-18 | 2023-10-24 | 吉林大学 | Personalized customization cervical vertebra zero-notch interbody fusion cage and manufacturing method |
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