CN108926740A - The preparation method and product of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing and application - Google Patents
The preparation method and product of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing and application Download PDFInfo
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- CN108926740A CN108926740A CN201810730042.9A CN201810730042A CN108926740A CN 108926740 A CN108926740 A CN 108926740A CN 201810730042 A CN201810730042 A CN 201810730042A CN 108926740 A CN108926740 A CN 108926740A
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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
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
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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
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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
- A61L27/18—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
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- 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
-
- 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
- B33Y80/00—Products made by 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
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
Abstract
The present invention relates to a kind of preparation method of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing and product and applications, the solid portion main component of structure as biological support based on polylactic acid-polyglycolic acid (PLGA) copolymer, nano-grade hydroxy apatite particle is as filling inorganic material, 3D printing, which is shaped, by fusion sediment prepares the compound fusion device bracket of Biodegradable nano hydroxylapatite, preparation comprising PLGA/ hydroxyapatite composite material, the preparation of fusion device model and application 3D plotter biometric print machine fusion sediment prepare cervical vertebral fusion cage.Neck Invasive lumbar fusion device of the present invention implantation is convenient, accelerates postoperative device merges with cervical vertebra, is not easy to skid off implant site and biocompatibility is high.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed, and allowing new osteocyte to be packed into, cavity is intracavitary, enhances the effect of its fusion.
Description
Technical field
The present invention relates to a kind of preparation methods of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing
And product and application, belong to medical material technical applications.
Technical background
Cervical spondylosis is that cervical intervertebral disk degenerative changes and its secondary and involve cervical neural root, spinal cord, vertebral artery
And foot lever nerve, seriously affect the life and work of patient.The patient with cervical Spondylopathy invalid for conservative therapy, according to its illness
Actual conditions implement operative treatment mode when necessary.Currently, precursor intervertebral fusion ligamentopexis is that the traumatic interverbebral disc for the treatment of is prominent
Out, the main means of the cervical spondylosiss such as poerior aspect of vertebral body hyperplasia and limitation posterior longitudinal ligament ossification.Cervical fusion cage exists
It is advantageously implemented immediate postoperative is stable, struts and maintains disc height, promotes fusion etc. in anterior approach, thus has obtained fast
Speed development.
Ideal Invasive lumbar fusion device should both be able to maintain segmental stabilization, provide ideal biomechanical environment, and can have
Achieve the purpose that fusion in the effect time.The Invasive lumbar fusion device of clinical application at present is mostly metal, absorbable poly-dl-lactide
(PDLLA), the materials such as polyether-ether-ketone (PEEK).The higher elasticity modulus of metal Invasive lumbar fusion device can generate biggish stress shielding
Effect causes skeletonization slow so that area of new bone lacks corresponding stress stimulation around fusion device, bone resorption, or even prosthese occurs
Surrounding osteolysis and prosthese migration；PDLLA Invasive lumbar fusion device mechanical strength is low to be easy it in surgical procedure in brittleness in it
Fragmentation in the process, the acids that degradation process generates cause serious tissue reaction may such as infection and osteolysis；PEEK fusion
Device does not have bioactivity, cannot realize with bone tissue really merge in vivo, most of surfaces are covered by fibr tissue
Lid is easy to produce fine motion, and then influences interpyramidal biomechanical stability.Hydroxyapatite (HAp) molecular formula is (Ca2
(PO4)6(OH)2) be a kind of inorganic matter that content is more in bone tissue, it have good biocompatibility, degradability and
Promote the effect of bone cell growth, and there is alkalescent.In recent years, HAp filled bone renovating material, further investigation hair as bracket
Existing material its mechanical strength after HAp mixing filling is high, degradable, promotes Bone Defect Repari after implantation.Neck Invasive lumbar fusion device is in art
Easily occurs the problems such as fusion device loosening, displacement, sinking and bone grafting do not merge afterwards.Invasive lumbar fusion device on the market is performed the operation to be opened when using
Situations such as mouthful wound is big, cumbersome, and patient often feels foreign matter, easily causes dysphagia.
Fusion sediment 3D printing technique is by being dissolved in spy for the natural polymer of biocompatibility or synthesis macromolecule etc.
It in fixed solvent, is squeezed by the heating of processing head, successively accumulation, finally obtains the solid zero of forming under control of the computer
Part, cost is relatively low, is the three-dimensional printing technology of current common application.
Summary of the invention
It is an object of that present invention to provide a kind of PLGA/ hydroxyapatite neck Invasive lumbar fusion devices of octahedral figure 3D printing
Preparation method is combined the neck Invasive lumbar fusion device of preparation by 3D printing technique and material modification, not only has excellent biology
Compatibility, and have and promote bone uptake performance and superior mechanical property.
Another object of the present invention is: providing a kind of PLGA/ hydroxyl of the octahedral figure 3D printing of above method preparation
Apatite neck Invasive lumbar fusion device product.
Another object of the present invention is to: a kind of application of the said goods is provided.
The object of the invention is realized by following proposal: a kind of 1. PLGA/ hydroxyapatite necks of octahedral figure 3D printing
The preparation method of Invasive lumbar fusion device, using 3D printing technique, which is characterized in that neck Invasive lumbar fusion device with the poly- second of polylactic acid-
Alkyd (PLGA) copolymer is used as and fills out as biological support material of main part, 0-30% mass fraction nano-grade hydroxy apatite particle
Charge, by fusion sediment shape 3D printing prepare the compound fusion device bracket of Biodegradable nano hydroxylapatite, comprising with
Lower step:
(1) preparation of PLGA/ hydroxyapatite composite material:
It is inserted after the PLGA of 200,000 molecular weight is cut into small pieces in the cavity for the Haake torque rheometer for being previously heated to 140 DEG C, by several times
Nanometer hydroxyapatite powder is added, is sufficiently mixed 1 hour or so, cavity is dismantled after being cooled to 70 DEG C and takes out material, will be mixed
Material afterwards is cut into the fritter that can be put into 3D printer；
(2) preparation of neck Invasive lumbar fusion device model:
Using CAD software editor using finite element human cervical spine real anatomy model as the finite element model of design considerations, save as
Stl normative document, and not closed edge is repaired to improve data model, carry out the adaptive data modeling of cervical vertebral fusion cage；
(3) neck Invasive lumbar fusion device cervical vertebral fusion cage is prepared using 3D plotter biometric print machine fusion sediment.
Wherein, the granular size of HAp described in step (1) is 200-400nm.
The present invention is to melt blending method of modifying preparation PLGA/ hydroxyapatite composite printing material is first passed through, with limited
First human cervical spine real anatomy model is design considerations, carries out the adaptive data modeling of cervical vertebral fusion cage, can be applied to load
Parametrization research and real figureization manufacture with boundary condition, material and bone topological structure, beat finally by 3D printer
Print off neck Invasive lumbar fusion device entity.
The present invention provides a kind of PLGA/ hydroxyapatite neck of octahedral figure 3D printing obtained according to above-mentioned preparation method
Portion's Invasive lumbar fusion device is asymmetrical octagonal cylinder shape, the asymmetric column construction of cavity is surrounded by by eight wall surfaces,
It is equipped with reinforcing rib in the cavity, in the left and right bone grafting hole with equipped with perforation on rear wall of fusion device cylindricality, inserts and plants in bone grafting hole
Bone；Fusion device upper and lower surface is parallel planar structures, and is equipped with the anti-slop serrations of fish scale-shaped arrangement in the upper and lower surfaces；It is merging
Threaded hole is set on device cylindricality antetheca, after linking surgical instrument, provides the fulcrum of bone hammer operation insertion fusion device, by fusion device with
Vertebra is fixed；Development needle one is provided on the cylindrical left front joint face of fusion device, joint face is equipped with development needle two behind the right side,
The development needle is made by stainless steel material and firmly insertion fusion device is as pilot pin, in surgical procedure, local X-ray
Irradiation under, play the role of cervical vertebral fusion cage and develop and position.
On the basis of above scheme, the reinforcing rib of upper and lower two Y-shapeds disposed in parallel is equipped in fusion device cavity inside.
The bone grafting hole is ellipse.
It is provided with auxiliary positioning hole in fusion device top and bottom, and in diagonal distribution, the development needle is located at auxiliary
Positioning hole is helped to fix.
The threaded hole includes countersunk head threaded hole, and the surface of the threaded hole is plane, can facilitate surgical instrument
Installation.
The anti-slop serrations are the isosceles triangle at 30 ° of angles.
Product of the present invention has excellent biocompatibility, controlled degradation, is a kind of applied to bone tissue reparation engineering
The device with very big potentiality in field.
Technical solution of the present invention is devised including fusion device ontology, and left and right, rear surface is equipped with the bone grafting hole of perforation, by
Cavity made of fusion device ontology surrounds；Fusion device ontology upper and lower surface has zigzag wave anti-slop serrations, and upper and lower surface is flat
Row planar structure；The antetheca setting threaded hole of fusion device ontology is connected with operation instrument.This fusion device ontology is similar octagon,
And corner is in rounded nature by chamfering.Fusion device bracket after compound, which has, promotees bone uptake, and inducing cell divides to osteoblast
The effect of change.In design, the fusion device is by fusion device ontology, bone grafting hole on ontology, and upper and lower surface has the anti-of sawtooth wave
Slip teeth is provided with the Y-shaped reinforcing rib being arranged in threaded hole and cavity in front end.Fusion device ontology is in octagon hollow cylinder knot
Structure.Fusion device product of the present invention has implantation accurate, easy to operate, accelerates postoperation recovery, and stability is good, is securely not easy to deviate from
Advantage.
The present invention provides a kind of PLGA/ hydroxyapatite neck intervertebral according to any of the above-described octahedral figure 3D printing
Application of the fusion device in the treatment of neck intervertebral.
The present invention has the advantages that
1. fusion device ontology upper and lower surface is equipped with the zigzag anti-slop serrations of similar fish scale arrangement, in arranged in parallel, anti-slop serrations are used to
Increase Invasive lumbar fusion device and centrum intervertebral contact area, increases frictional force between cervical vertebral fusion cage and cervical vertebral body, be allowed to fixed
Stablize, is not easy to skid off implant site, implant devices is effectively prevent to skid off between centrum.
2. fusion device ontology of the present invention is similar octagon, and front is big, and rear portion is small, and in front, setting is for installing operation
The threaded hole of instrument, it is more convenient, accurate convenient for positioning, implantation when installing instrument.
3. the left and right and rear wall of fusion device is provided with bone grafting hole, bone grafting, reinforcing material and centrum group are inserted in bone grafting hole
The fusion speed knitted, allows new osteocyte to be packed into cavity, enhances the effect of its fusion.
4. fusion device is internally provided with two " Y " font reinforcing ribs, it can effectively reinforce the load-bearing effect of octagonal cylinder
Fruit, and it is easy to merging for material and centrum portion, it effectively prevent fusion device to penetrate and collapses in hypocentrum.
5. cervical vertebral fusion cage is combined by PLGA/ hydroxyapatite, biocompatibility is high, has and promotees bone uptake, lures
Guided cell accelerates merging for postoperative device and cervical vertebra to the effect of osteoblast differentiation.
Detailed description of the invention
Attached drawing 1 is main view；
Attached drawing 2 is rearview；
Attached drawing 3 is left view；
Attached drawing 4 is right view；
Attached drawing 5 is top view；
Attached drawing 6 is bottom view；
Attached drawing 7 is perspective view；
Attached drawing 8 is usage state diagram；
Figure label explanation:
1 --- main body；
2 --- left bone grafting hole；3 --- right bone grafting hole；4 --- rear bone grafting hole；
51,52 --- upper and lower anti-slop serrations；6 --- threaded hole；
7,8 --- development needle one, two；
9,10 --- upper and lower " Y " font support.
Specific embodiment
Embodiment 1
A kind of preparation method of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing, using 3D printing skill
Art, neck Invasive lumbar fusion device using polylactic acid-polyglycolic acid (PLGA) copolymer as biological support main body 1, it is heavy by melting
Product forming 3D printing prepares the compound fusion device bracket of Biodegradable nano hydroxylapatite comprising the steps of:
(1) preparation of PLGA/ hydroxyapatite composite material:
The PLGA of 200,000 molecular weight is cut into small pieces, is put into the print chamber body of 140 DEG C of preheated 3D plotter, 3D interlayer
0.5 millimeter of piling height, 3D printing makes cervical fusion device；
(2) preparation of neck Invasive lumbar fusion device model:
Referring to Fig. 1-Fig. 6, using CAD software editor using finite element human cervical spine real anatomy model as the finite element of design considerations
Model saves as stl normative document, and repairs not closed edge to improve data model, carries out the adaptation of cervical vertebral fusion cage
Property data modeling；Mainly comprising main body 1 in similar octagon column structure in the present embodiment, asymmetrical octagonal cylinder shape has
Conducive to cervical vertebral fusion cage implant surgery operation.Cervical vertebral fusion cage main body 1 be equipped with the left bone grafting hole 2 of connection, right bone grafting hole 3 and after
Bone grafting hole 4 is located on the wall of the left end of fusion device ontology, right end and rear end.Bone grafting is inserted in bone grafting hole, can accelerate tissue
Speed is merged with material, allows the new osteocyte to be packed into hollow cavity, enhances the effect of its fusion.
(3) neck Invasive lumbar fusion device cervical vertebral fusion cage is prepared using 3D plotter biometric print machine fusion sediment.
The anti-slop serrations that the upper and lower surface design of cervical vertebral fusion cage main body 1 has fish scale-shaped to arrange, respectively upper and lower anti-slop serrations 51,52,
Anti-slop serrations be 30 ° of angles isosceles triangle, this design can increase with cervical vertebral body contact surface, to increase instrument and cervical vertebra
Interpyramidal friction, and be not easy to deviate from Invasive lumbar fusion device from the lower end surface of upper cervical spine centrum and the upper surface of Cervical vertebra centrum,
Vertebral body structure up and down can effectively be merged.
Threaded hole 6 is arranged in the front end of cervical vertebral fusion cage main body 1, after threaded hole 6 connects surgical instrument, provides bone hammer behaviour
The fulcrum for making insertion fusion device, fusion device and vertebra are fixed.The surface of screw hole is plane, can facilitate the peace of surgical instrument
Dress.
Cervical vertebral fusion cage main body 1 is provided with development needle 1 in the wall surface junction of right front ends, and the wall surface at left back end connects
The place of connecing is provided with development needle 28, and development needle is made by stainless steel material and is firmly inserted into main thermometer 1, in surgical procedure,
Whether under the irradiation of local X-ray, pilot pin plays the role of cervical vertebral fusion cage and develops and position, prompt doctor's implantation position appropriate
In place.
Two upper and lower " Y " font being parallel to each other supports 9,10 are provided in the cavity of cervical vertebral fusion cage main body 1, with
Reinforce the compressive strength of main body 1.
With reference to Fig. 7, in surgical procedure, first with instrument by pyramidal support, then will filling inorganic-bone cement or sclerotin to neck
In Invasive lumbar fusion device is hollow, in level angle push-in centrum gap.
Embodiment 2
Similar with embodiment 1, only nanometer hydroxyapatite powder is 10% mass fraction in PLGA/ hydroxyapatite.
Firstly, filling is previously heated to 140 degrees Celsius of Haake torque rheometer after PLGA (200,000 molecular weight) is cut into small pieces
Cavity in, by several times be added 10% mass fraction nanometer hydroxyapatite powder, about 1 hour is sufficiently mixed, after being cooled to 70 °
Disassembly cavity takes out material.Mixed material is cut into small pieces in the print chamber body for filling in 3D plotter with scissors, if
It sets 140 degrees Celsius to preheat 30 minutes, is arranged 0.5 millimeter of interlayer piling height, printing and making cervical fusion device.
It mainly include main body 1 in similar octagon referring to Fig. 1-Fig. 6, in the present embodiment in terms of cervical vertebral fusion cage data model
Column structure, asymmetrical octagonal cylinder shape are conducive to cervical vertebral fusion cage implant surgery operation.In cervical vertebral fusion cage main body 1
Left bone grafting hole 2, right bone grafting hole 3 and rear bone grafting hole 4 equipped with connection, are located on the left and right and rear wall of fusion device main body 1.
Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed, allows new osteocyte to be packed into hollow cavity, enhances it and melt
The effect of conjunction.
The anti-slop serrations 5 that the upper and lower surface design of cervical vertebral fusion cage main body 1 has fish scale-shaped to arrange, anti-slop serrations be 30 ° of angles etc.
Lumbar triangle shape, this design can increase with cervical vertebral body contact surface, to increase the friction between instrument and cervical vertebral body, without
Deviate from Invasive lumbar fusion device from the lower end surface of upper cervical spine centrum and the upper surface of Cervical vertebra centrum, can effectively merge vertebra up and down
Body structure.
Threaded hole 6 is arranged in the front end wall surface of cervical vertebral fusion cage main body 1, after threaded hole 6 links surgical instrument, provides bone
The fulcrum of hammer operation insertion fusion device, fusion device and vertebra are fixed.The surface of screw hole is plane, can facilitate surgical instrument
Installation.
Cervical vertebral fusion cage main body 1 is provided with development needle 1 in the junction of right front ends, is provided at the link at left back end
Development needle 28, development needle are made by stainless steel material and are firmly inserted into main body 1, in surgical procedure, the irradiation of local X-ray
Under, whether pilot pin plays the role of cervical vertebral fusion cage and develops and position, prompt doctor's implantation position appropriate in place.
Cervical vertebral fusion cage main body 1 is provided with the support of " Y " font in cavity, to reinforce the compressive strength of main body 1.
With reference to Fig. 7, in surgical procedure, first with instrument by pyramidal support, then will filling inorganic-bone cement or sclerotin to neck
In Invasive lumbar fusion device is hollow, in level angle push-in centrum gap.
Embodiment 3
Similar with embodiment 1, only nanometer hydroxyapatite powder is 20% mass fraction in PLGA/ hydroxyapatite.
Firstly, filling is previously heated to 140 degrees Celsius of Haake torque rheometer after PLGA (200,000 molecular weight) is cut into small pieces
Cavity in, by several times be added 20% mass fraction nanometer hydroxyapatite powder, about 1 hour is sufficiently mixed, after being cooled to 70 °
Disassembly cavity takes out material.Mixed material is cut into small pieces in the print chamber body for filling in 3D plotter with scissors, if
It sets 140 degrees Celsius to preheat 30 minutes, is arranged 0.5 millimeter of interlayer piling height, printing and making cervical fusion device.
It mainly include main body 1 in similar octagon referring to Fig. 1-Fig. 6, in the present embodiment in terms of cervical vertebral fusion cage data model
Column structure, asymmetrical octagonal cylinder shape are conducive to cervical vertebral fusion cage implant surgery operation.In cervical vertebral fusion cage main body 1
Left bone grafting hole 2, right bone grafting hole 3 and rear bone grafting hole 4 equipped with connection, are located at the wall of the left and right and rear end of fusion device main body 1
On.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed, and new osteocyte is allowed to be packed into hollow cavity, enhances
Its effect merged.
The anti-slop serrations that the upper and lower surface design of cervical vertebral fusion cage main body 1 has fish scale-shaped to arrange, anti-slop serrations are the isosceles at 30 ° of angles
Triangle, this design can increase with cervical vertebral body contact surface, to increase the friction between instrument and cervical vertebral body, and be not easy
Deviate from Invasive lumbar fusion device from the lower end surface of upper cervical spine centrum and the upper surface of Cervical vertebra centrum, can effectively merge hypocentrum
Structure.
Threaded hole 6 is arranged in the front end of cervical vertebral fusion cage main body 1, after threaded hole 6 links surgical instrument, provides bone hammer behaviour
The fulcrum for making insertion fusion device, fusion device and vertebra are fixed.The surface of screw hole is plane, can facilitate the peace of surgical instrument
Dress.
Cervical vertebral fusion cage main body 1 is provided with development needle 1 in the wall surface junction of right front ends, and the wall surface at left back end connects
The place of connecing is provided with development needle 28, and development needle is made by stainless steel material and is firmly inserted into main body 1, in surgical procedure, part
Under the irradiation of X-ray, pilot pin plays the role of cervical vertebral fusion cage and develops and position, and prompts whether doctor's implantation position appropriately arrives
Position.
Cervical vertebral fusion cage main body 1 is provided with the support of " Y " font in central hollow region, to reinforce the compressive strength of main body 1.
With reference to Fig. 7, in surgical procedure, first with instrument by pyramidal support, then will filling inorganic-bone cement or sclerotin to neck
In Invasive lumbar fusion device is hollow, in level angle push-in centrum gap.
Embodiment 4
Similar with embodiment 1, only nanometer hydroxyapatite powder is 30% mass fraction in PLGA/ hydroxyapatite.
Firstly, filling is previously heated to 140 degrees Celsius of Haake torque rheometer after PLGA (200,000 molecular weight) is cut into small pieces
Cavity in, by several times be added 30% mass fraction nanometer hydroxyapatite powder, about 1 hour is sufficiently mixed, after being cooled to 70 °
Disassembly cavity takes out material.Mixed material is cut into small pieces in the print chamber body for filling in 3D plotter with scissors, if
It sets 140 degrees Celsius to preheat 30 minutes, is arranged 0.5 millimeter of interlayer piling height, printing and making cervical fusion device.
It mainly include main body 1 in similar octagon referring to Fig. 1-Fig. 6, in the present embodiment in terms of cervical vertebral fusion cage data model
Column structure, asymmetrical octagonal cylinder shape are conducive to cervical vertebral fusion cage implant surgery operation.In cervical vertebral fusion cage main body 1
Left bone grafting hole 2, right bone grafting hole 3 and rear bone grafting hole 4 equipped with connection, are located at the left and right and rear end of fusion device main body 1
On wall.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed, and new osteocyte is allowed to be packed into hollow cavity, increases
The effect of its strong fusion.
The upper and lower anti-slop serrations 51,52 that the upper and lower surface design of cervical vertebral fusion cage main body 1 has fish scale-shaped to arrange, anti-slop serrations are
The isosceles triangle at 30 ° of angles, this design can increase with cervical vertebral body contact surface, to increase between instrument and cervical vertebral body
Friction, and be not easy to deviate from Invasive lumbar fusion device from the lower end surface of upper cervical spine centrum and the upper surface of Cervical vertebra centrum, it can be effective
Merge vertebral body structure up and down.
Threaded hole 6 is arranged in the front end wall surface of cervical vertebral fusion cage main body 1, after threaded hole 6 links surgical instrument, provides bone
The fulcrum of hammer operation insertion fusion device, fusion device and vertebra are fixed.The surface of screw hole is plane, can facilitate surgical instrument
Installation.
Cervical vertebral fusion cage main body 1 is provided with development needle 1 in the wall surface junction of right front ends, and the wall surface at left back end connects
Place is provided with development needle 28, and development needle is made by stainless steel material and is firmly inserted into main thermometer 1, in surgical procedure, office
Under the irradiation of portion's X-ray, pilot pin plays the role of cervical vertebral fusion cage and develops and position, and prompts whether doctor's implantation position appropriately arrives
Position.
Cervical vertebral fusion cage main body 1 is provided with the support of " Y " font in cavity, to reinforce the compressive strength of main body 1.
With reference to Fig. 7, in surgical procedure, first with instrument by pyramidal support, then will filling inorganic-bone cement or sclerotin to neck
In Invasive lumbar fusion device cavity, in level angle push-in centrum gap.
Claims (9)
1. the preparation method of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of a kind of octahedral figure 3D printing, using 3D printing
Technology, which is characterized in that neck Invasive lumbar fusion device is using polylactic acid-polyglycolic acid (PLGA) copolymer as biological support main body material
Material, 0-30% mass fraction nano-grade hydroxy apatite particle shape 3D printing preparation biology as filler material, by fusion sediment
The compound fusion device bracket of degradable nano hydroxyapatite lime stone comprising the steps of:
(1) preparation of PLGA/ hydroxyapatite composite material:
It is inserted after the PLGA of 200,000 molecular weight is cut into small pieces in the cavity for the Haake torque rheometer for being previously heated to 140 DEG C, by several times
Nanometer hydroxyapatite powder is added, is sufficiently mixed 1 hour, cavity is dismantled after being cooled to 70 DEG C and takes out material, it will be mixed
Material is cut into the fritter that can be put into 3D printer；
(2) preparation of neck Invasive lumbar fusion device model:
Using CAD software editor using finite element human cervical spine real anatomy model as the finite element model of design considerations, save as
Stl normative document, and not closed edge is repaired to improve data model, carry out the adaptive data modeling of cervical vertebral fusion cage；
(3) neck Invasive lumbar fusion device cervical vertebral fusion cage is prepared using 3D plotter biometric print machine fusion sediment.
2. the preparation side of the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing according to claim 1
Method, which is characterized in that the granular size of HAp described in step (1) is 200-400nm.
3. the PLGA/ hydroxyapatite neck vertebra for the octahedral figure 3D printing that one kind is obtained to 2 preparation methods according to claim 1
Between fusion device, which is characterized in that be asymmetrical octagonal cylinder shape, being surrounded by eight wall surfaces internal has the asymmetric of cavity
Column construction inserts bone grafting in bone grafting hole in the fusion device cylindricality left and right bone grafting hole with equipped with perforation on rear wall；On fusion device
Lower surface is parallel planar structures, and is equipped with the anti-slop serrations of fish scale-shaped arrangement in the upper and lower surfaces；On fusion device cylindricality antetheca
Threaded hole is set, after connecting surgical instrument, the fulcrum of bone hammer operation insertion fusion device is provided, fusion device and vertebra are consolidated
It is fixed；Development needle one is provided on the cylindrical left front joint face of fusion device, joint face is equipped with development needle two, the development behind the right side
Needle is made by stainless steel material and firmly insertion fusion device is as pilot pin, in surgical procedure, under the irradiation of local X-ray,
Play the role of cervical vertebral fusion cage to develop and position.
4. the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing, feature exist according to claim 3
In in reinforcing rib of the fusion device cavity inside equipped with upper and lower two Y-shapeds disposed in parallel.
5. the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing, feature exist according to claim 3
In the bone grafting hole is ellipse.
6. the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing, feature exist according to claim 3
In fusion device is provided with auxiliary positioning hole in top and bottom, and in diagonal distribution, the development needle is placed in auxiliary positioning
It is fixed in hole.
7. the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing, feature exist according to claim 3
In the threaded hole includes countersunk head threaded hole, and the surface of the threaded hole is plane, can facilitate the installation of surgical instrument.
8. the PLGA/ hydroxyapatite neck Invasive lumbar fusion device of octahedral figure 3D printing, feature exist according to claim 3
In the anti-slop serrations are the isosceles triangle at 30 ° of angles.
9. a kind of PLGA/ hydroxyapatite neck intervertebral of any one according to claim 3-8 octahedral figure 3D printing
Application of the fusion device in the treatment of neck intervertebral.
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