CN109044571A - The preparation method and product of half-moon-shaped 3D printing PLGA/ hydroxyapatite waist Invasive lumbar fusion device and application - Google Patents
The preparation method and product of half-moon-shaped 3D printing PLGA/ hydroxyapatite waist Invasive lumbar fusion device and application Download PDFInfo
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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
- 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
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30112—Rounded shapes, e.g. with rounded corners
- A61F2002/30131—Rounded shapes, e.g. with rounded corners horseshoe- or crescent- or C-shaped or U-shaped
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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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
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
The present invention relates to a kind of preparation method of the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of semilune 3D printing and product and application, the preparation comprising PLGA/ hydroxyapatite composite material, the preparation of fusion device model and application 3D plotter biometric print machine fusion sediment prepare waist Invasive lumbar fusion device.Waist Invasive lumbar fusion device of the present invention implantation is convenient, accelerates postoperative device merges with lumbar vertebrae, is not easy to skid off implant site and biocompatibility is high.Waist Invasive lumbar fusion device of the present invention implantation is convenient, accelerates postoperative device merges with lumbar vertebrae, is not easy to skid off implant site and biocompatibility is high.
Description
Technical field
The present invention relates to the preparation methods and production of a kind of semilune 3D printing PLGA/ hydroxyapatite waist Invasive lumbar fusion device
Product and application belong to the application field of medical instrument preparation and processing.
Technical background
In recent years, the proposition of " interbody fusion " is that spinal surgery brings new concept and causes worldwide wide
General concern.Its concept, which refers to, struts continued tension provided by effect by fusion device implantation, and the tissue merged around centrum is such as fine
Ring, front and back longitudinal ligament and paraspinal muscle are tieed up, so that whole reach a kind of super static stability, eventually by interplantation instrument and vertebra
Interfacial contact between body end bone and reach Fusion Strain.The protrasion of the lumbar intervertebral disci is a kind of multiple disease, and lumbar degenerative
Lesion generally requires operative treatment, and the excision of nucleus pulposus causes the change of spinal biomechanics, and fixed in spinal surgery
The appearance of system improves the stability of intervertebral fusion, effectively increases the success rate of fusion.
Invasive lumbar fusion device as mediator needs mechanical strength, elasticity modulus, the corrosion-resistant and various aspects such as antifatigue
Requirement.Clinical application at present it is more be polyether-ether-ketone (PEEK) material and titanium metal net material, however PEEK is as fusion
The making material of device do not have bioactivity, with upper sending down the fishbone endplate tissue can not achieve it is real merge, most of surface quilts
Fibr tissue covering is easy to produce fine motion, and then influences interpyramidal biomechanical stability;Titanium Invasive lumbar fusion device is higher
Elasticity modulus can generate biggish stress shielding effect and led so that area of new bone lacks corresponding stress stimulation around fusion device
Cause skeletonization slow, bone resorption, or even there is periprosthetic osteolysis and prosthese migration.Ideal absorbable interbody cage exists
Just there should be enough intensity when implantation, develop intensity with degradation process and gradually decrease, it is just advantageous that load is gradually transferred to host bone
In New born formation and ensure certain bone fusion, implantation material is fully absorbed and substituted by autologous bone, ultimately forms biology fusion.
PLGA is polymerized by a certain percentage by polylactic acid and poly- acetate multipolymer, and intensity is suitable with PLLA, has good biofacies
Capacitive, degradation rate is adjustable, fully absorbs the time at 9-18 months, the PLLA than fully absorbing time-consuming 3-5.7 significantly contracts
It is short.Hydroxyapatite (HAp) molecular formula is (Ca2(PO4)6(OH)2) it is a kind of inorganic matter that content is more in bone tissue, it has
There are good biocompatibility, degradability and promote bone cell growth, and there is alkalescent.In recent years, HAp made
Bone renovating material is filled for bracket, further investigation discovery material its mechanical strength after HAp mixing filling is high, degradable, implantation
After promote Bone Defect Repari.
Easily there is the problems such as fusion device loosening, displacement, sinking and bone grafting do not merge after surgery in neck Invasive lumbar fusion device.Market
On Invasive lumbar fusion device perform the operation that open wound when using is big, and cumbersome, patient often feels foreign matter, easily cause swallow it is tired
Situations such as difficult.
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
In order to overcome the deficiencies of the prior art, it is an object of that present invention to provide a kind of PLGA/ hydroxyl phosphorus of semilune 3D printing
The preparation method of lime stone waist Invasive lumbar fusion device.Not only there is excellent biocompatibility, controlled degradation, promote bone uptake performance
And mechanical property is improved.
Another object of the present invention is: providing a kind of PLGA/ hydroxyl phosphorus of the semilune 3D printing of above method preparation
Lime stone waist Invasive lumbar fusion device product.The postoperative fusion device that is less prone to loosens, displacement, sinks and bone grafting the problems such as not merging, and
It is easy to operate.
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 PLGA/ hydroxyapatite waist intervertebral of semilune 3D printing
The preparation method of fusion device, using 3D printing technique, using polylactic acid-polyglycolic acid (PLGA) copolymer as biological support main body
Material, 0-30% mass fraction nano-grade hydroxy apatite particle is as filler material 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 degrees Celsius,
Nanometer hydroxyapatite powder is added by several times, is sufficiently mixed about 1 hour, cavity is dismantled after being cooled to 70 DEG C and takes out material, will be mixed
Material after conjunction is cut into the fritter that can be put into 3D printer;
(2) preparation of fusion device model:
Using finite element human body lumbar vertebrae true model as design considerations, using CAD software editor's finite element model, stl mark is saved as
Quasi- file, and not closed edge is repaired to improve the adaptive data model of lumbar fusion cages;
(3) waist Invasive lumbar fusion device is prepared using 3D plotter biometric print machine fusion sediment.
The present invention passes through melt blending method of modifying preparation PLGA/ hydroxyapatite composite printing material first, with limited
First human body lumbar vertebrae true model is design considerations, using CAD software editor's finite element model, and repairs not closed edge with complete
The adaptive data model of kind lumbar fusion cages;It can be applied to the parameter of load and boundary condition, material and bone topological structure
Change research and real figureization manufacture.Finally waist Invasive lumbar fusion device entity is printed in German 3D plotter printer.This
Kind waist Invasive lumbar fusion device has excellent biocompatibility, controlled degradation, promotees bone uptake performance and outstanding mechanical property
Can, it is a kind of device with very big potentiality applied to bone tissue reparation engineering field.
The present invention based on polylactic acid-polyglycolic acid (PLGA) copolymer structure as biological support main component,
Nano-grade hydroxy apatite particle is mixed into PLGA/HAp masterbatch with PLGA as filling inorganic material, then heavy by melting
Product forming 3D printing prepares the compound fusion device bracket of Biodegradable nano hydroxylapatite.With rush bone uptake, inducing cell
Effect to osteoblast differentiation, not only biocompatibility, controlled degradation, rush bone uptake superior performance, and mechanical property
It is excellent.
On the basis of above scheme, the granular size of HAp described in step (1) is 200-400nm.
The present invention provides a kind of PLGA/ hydroxyapatite of half-moon-shaped 3D printing obtained according to preparation method described above
Waist Invasive lumbar fusion device, lumbar fusion cages are irregular semilune hollow body, and corner is in round and smooth shape by chamfering, this
Body at least surrounds internal cavities by front and back arcwall and lower planes wall, reinforcing rib is equipped in cavity, the side of ontology is in point
Sharp portion is as leading-in end;Ontology is equipped with the bone grafting hole symmetrically penetrated through, is located on the front and back arcwall of fusion device ontology, plants
Bone grafting is inserted in bone hole, can accelerate tissue and material merges speed, allows new osteocyte to be packed into hollow cavity, enhances its fusion
Effect it is compound after fusion device bracket have promote bone uptake, effect of the inducing cell to osteoblast differentiation;Upper and lower surfaces are
Parallel planar structures, the anti-slop serrations equipped with fish scale-shaped arrangement;Threaded hole is arranged in the other side of ontology, and the surface of the threaded hole is flat
Face after connecting surgical instrument as operating side, provides the fulcrum of bone hammer operation insertion fusion device, fusion device and vertebra is consolidated
It is fixed, the installation of surgical instrument can be facilitated;It is mutually the development needle of the angle of cut at the top of ontology sharp portion and upper and lower surfaces setting, is shown
Shadow needle is made by stainless steel material and is firmly inserted into ontology, and in surgical procedure, under the irradiation of local X-ray, pilot pin is played
Whether the effect that lumbar fusion cages develop and position prompts doctor's implantation position appropriate in place.
It is half-moon-shaped hollow structure that the present invention, which is devised including fusion device ontology, and corner is in rounded nature by chamfering,
The bone grafting hole symmetrically penetrated through is arranged in the arcuate structure of fusion device ontology;Fusion device ontology upper and lower surfaces have zigzag wave
Unrestrained anti-slop serrations;The rear end setting threaded hole of fusion device ontology is connected with operation instrument and the sharp portion of front end is as incision
Head more conducively operates.It is less prone to the problems such as fusion device loosening, displacement, sinking and bone grafting do not merge after surgery.Product of the present invention
It is accurate with implantation, it is easy to operate, accelerate postoperation recovery, stability is good, the advantages of securely being not easy.
The anti-slop serrations are the isosceles triangle at 30 ° of angles.
The reinforcing rib is the reinforcing rib of " M " font, is located in Body Lumen and is divided into two M type reinforcing ribs up and down,
Five fulcrums of " M " type support the arcwall inner wall equipped with bone grafting hole respectively, increase the anti-compression properties of lumbar fusion cages.
The bone grafting hole is ellipse.
The threaded hole is countersunk head threaded hole.
Fusion device ontology is provided with auxiliary positioning hole on the top of upper and lower wall and sharp portion.
The development needle is fixed on the positioning hole.
The present invention provides a kind of PLGA/ hydroxyapatite waist Invasive lumbar fusion device of above-mentioned half-moon-shaped 3D printing in waist vertebra
Between treatment in application.Operation opening wound is small, and easy to operate, patient's no foreign body sensation.
Waist Invasive lumbar fusion device of the present invention implantation is convenient, accelerates postoperative device merges with lumbar vertebrae, is not easy to skid off plant
Enter position and biocompatibility is high.
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 lumbar fusion cages and lumbar vertebra, be allowed to fixed
Stablize, prevents implant devices from skidding off between centrum.
2. fusion device ontology of the present invention is half-moon-shaped, and front is small, and rear portion is big, and back-end operations end is provided with threaded hole,
Front end is the sharp incision head of original words processing, more accurate convenient for positioning, implantation when installing instrument.
3. being provided with bone grafting hole on two arcwall faces of fusion device, bone grafting can be inserted, reinforcing material merges speed with centrum
And effect.
4. fusion is internally provided with two " M " font reinforcing ribs, it can effectively reinforce former semi-moon shaped load bearing effect,
And it is easy to merging for material and centrum portion, it effectively prevent fusion device to penetrate and collapses in hypocentrum.
5. lumbar fusion cages are combined by PLGA/ hydroxyapatite, have and promote bone uptake, inducing cell is to skeletonization
The effect of cell differentiation.
Detailed description of the invention
Attached drawing 1 is the main view of embodiment 1,2,3,4;
Attached drawing 2 is the rearview of embodiment 1,2,3,4;
Attached drawing 3 is the right view of embodiment 1,2,3,4;
Attached drawing 4 is the left view of embodiment 1,2,3,4;
Attached drawing 5 is the top view of embodiment 1,2,3,4;
Attached drawing 6 is the bottom view of embodiment 1,2,3,4;
Attached drawing 7 is the perspective view of embodiment 1,2,3,4;
Attached drawing 8 is the main view of embodiment 5,6,7,8;
Attached drawing 9 is the rearview of embodiment 5,6,7,8;
Attached drawing 10 is the right view of embodiment 5,6,7,8;
Attached drawing 11 is the left view of embodiment 5,6,7,8;.
Attached drawing 12 is the top view of embodiment 5,6,7,8;
Attached drawing 13 is the bottom view of embodiment 5,6,7,8;
Attached drawing 14 is the perspective view of embodiment 5,6,7,8;
Attached drawing 15 is usage state diagram;
Figure label explanation:
1,1 ' --- ontology, 10,10 ' --- sharp portion;
2,2 ' --- planting in advance bone hole;3,3 ' --- rear bone grafting hole;
4,4 ' --- upper anti-slop serrations;8,8 ' --- upper and lower anti-slop serrations;
5,5 ' --- threaded hole;
6,6 ' --- development needle one, 7,7 ' --- development needles two;
91, " M " font supports under 91 ' --- upper " M " font supports, 92,92 ' ---.
Specific embodiment
Embodiment 1
A kind of preparation method of the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of semilune 3D printing, using 3D printing technique,
Using polylactic acid-polyglycolic acid (PLGA) copolymer as biological support material of main part comprising the steps of:
(1) preparation of PLGA/ hydroxyapatite composite material:
The PLGA of 200,000 molecular weight is cut into the fritter that can be put into 3D printer;
Using finite element human body lumbar vertebrae true model as design considerations, using CAD software editor's finite element model, stl mark is saved as
Quasi- file, and not closed edge is repaired to improve the adaptive data model of lumbar fusion cages;
Waist Invasive lumbar fusion device is prepared using 3D plotter biometric print machine fusion sediment, above-mentioned material fritter fills in 3D
In the print chamber body of plotter, 140 degrees Celsius of preheatings, 0.5 millimeter of interlayer piling height, 3D printing makes lumbar intervertebral fusion
Device.
In terms of lumbar fusion cages data model, referring to Fig. 1-7, mainly comprising main structure in half-moon-like type in the present embodiment
Hollow structure ontology 1, asymmetrical half-moon-shaped side are crossed to form sharp portion 10 as leading-in end by front and back arc, have implantation
The effect of guidance is conducive to the implant surgery operation of lumbar fusion cages;Ontology 1 be equipped with symmetrically penetrate through forward and backward bone grafting hole 2,
3, it is located on the forward and backward arcwall of fusion device ontology.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed
Degree, allows new osteocyte to be packed into hollow cavity, enhances the effect of its fusion.
The upper and lower anti-slop serrations 4,8 that the upper and lower surfaces design of ontology 1 has fish scale-shaped to arrange, anti-slop serrations are the isosceles at 30 ° of angles
Triangle, this design can increase to be not easy to make with lumbar vertebra contact surface to increase the friction between instrument and lumbar vertebra
Invasive lumbar fusion device is deviate from from the lower end surface of upper lumbar spine centrum and the upper surface of lower lumbar spine centrum, can effectively merge hypocentrum knot
Structure.
After the other side setting threaded hole 5 of ontology 1 is used as operating side, threaded hole 5 to connect surgical instrument, bone hammer behaviour is provided
The fulcrum for making insertion fusion device, fusion device and vertebra are fixed.The surface of threaded hole 5 is plane, can facilitate surgical instrument
Installation.
The top of 1 sharp portion 10 of ontology is provided with development needle 1, upper wall surface is provided with development needle 27, development needle by
Stainless steel material makes and is firmly inserted into ontology 1, and in surgical procedure, under the irradiation of local X-ray, pilot pin plays lumbar vertebrae and melts
Whether the effect that clutch is developed and positioned prompts doctor's implantation position appropriate in place.
It is provided with upper and lower " M " font support 91,92, in 1 cavity of ontology to reinforce the compressive strength of ontology 1.
With reference to Figure 15, in surgical procedure, ontology 1 of the present invention is introduced from leading end, is first then filled out pyramidal support with instrument
It is hollow interior to waist Invasive lumbar fusion device to fill inorganic-bone cement or sclerotin, in level angle push-in centrum gap.
Embodiment 2
The present embodiment is approximate with embodiment 1, and structure is identical, only the material based on PLGA, and the nanometer of 10% mass fraction is added
Hydroxylapatite powder.
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 (Hap), be sufficiently mixed about 1 hour, be cooled to
Cavity is dismantled after 70 ° to take out material.Mixed material is cut into small pieces with scissors and fills in the printing cavity of 3D plotter
It is interior, it is arranged 140 degrees Celsius and preheats 30 minutes, is arranged 0.5 millimeter of interlayer piling height, printing and making cervical fusion device.
The granular size of the HAp is 200-400nm.
In terms of lumbar fusion cages data model, referring to Fig. 1-Fig. 7, mainly comprising main structure in half-moon-like in the present embodiment
Type hollow body 1, asymmetrical half-moon-shaped side are crossed to form sharp portion 10 as leading end by front and back arc, there is implantation to draw
The effect led is conducive to the implant surgery operation of lumbar fusion cages.Ontology 1 is equipped with the forward and backward bone grafting hole 2,3 of connection, respectively
On the front and back arcwall of ontology 1.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed, makes new bone thin
Born of the same parents are packed into hollow cavity, enhance the effect of its fusion.
The upper and lower anti-slop serrations 4,8 that the upper and lower surface design of ontology 1 has fish scale-shaped to arrange, anti-slop serrations are the isosceles three at 30 ° of angles
It is angular, this design can increase with lumbar vertebra contact surface, to increase the friction between instrument and lumbar vertebra, and be not easy to make
Invasive lumbar fusion device is deviate from from the lower end surface of upper lumbar spine centrum and the upper surface of lower lumbar spine centrum, can effectively merge hypocentrum knot
Structure.
The other side setting threaded hole 5 of ontology 1 is used as operating side, after threaded hole 5 connects surgical instrument, provides bone hammer
The fulcrum of operation insertion fusion device, fusion device and vertebra are fixed.The surface of screw hole is plane, can facilitate surgical instrument
Installation.
Development needle 1 is arranged in ontology 1 at the top of sharp end, upper surface is provided with development needle 27, development needle is by stainless steel
Material makes and is firmly inserted into ontology 1, and in surgical procedure, under the irradiation of local X-ray, it is aobvious that pilot pin plays lumbar fusion cages
Whether shadow and the effect positioned prompt doctor's implantation position appropriate in place.
Ontology 1 is provided with " M " font in central hollow region and supports, upper and lower " M " the font support 91 of the present embodiment setting,
92, to reinforce the compressive strength of ontology 1.
With reference to Figure 15, in surgical procedure, 1 bootstrap end of ontology is introduced, and first with instrument then pyramidal support will be filled nothing
Machine bone cement or sclerotin to waist Invasive lumbar fusion device ontology 1 it is hollow in, in level angle push-in centrum gap.
Embodiment 3
The present embodiment is approximate with embodiment 1, and structure is identical, only the material based on PLGA, and the nanometer of 20% mass fraction is added
Hydroxylapatite powder.
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.
In terms of lumbar fusion cages data model, referring to Fig. 1-Fig. 7, mainly comprising main structure in half-moon-like in the present embodiment
Type hollow body 1, asymmetrical half-moon-shaped side are crossed to form sharp portion 10 as leading end by front and back arc, there is implantation to draw
The effect led is conducive to the implant surgery operation of lumbar fusion cages.Ontology 1 is equipped with the forward and backward bone grafting hole 2,3 of connection, respectively
On two forward and backward arcwalls of fusion device ontology 1.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material merges speed
Degree, allows new osteocyte to be packed into hollow cavity, enhances the effect of its fusion.
The upper and lower anti-slop serrations 4,8 that the upper and lower surface design of ontology 1 has fish scale-shaped to arrange, anti-slop serrations are the isosceles three at 30 ° of angles
It is angular, this design can increase with lumbar vertebra contact surface, to increase the friction between instrument and lumbar vertebra, and be not easy to make
Invasive lumbar fusion device is deviate from from the lower end surface of upper lumbar spine centrum and the upper surface of lower lumbar spine centrum, can effectively merge hypocentrum knot
Structure.
The other side setting threaded hole 5 of lumbar fusion cages ontology 1 is used as operating side, after threaded hole 5 links surgical instrument,
The fulcrum of bone hammer operation insertion fusion device is provided, fusion device and vertebra are fixed.The surface of screw hole is plane, can be convenient
The installation of surgical instrument.
Development needle 1 is set at the top of 1 sharp end of ontology, the upper surface of nearly leading end is provided with development needle 27, is developed
Needle is made by stainless steel material and is firmly inserted into ontology 1, and in surgical procedure, under the irradiation of local X-ray, pilot pin plays waist
Whether the effect that vertebra fusion device develops and positions prompts doctor's implantation position appropriate in place.
Lumbar fusion cages ontology 1 is provided with the support of " M " font in central hollow region, to reinforce the compressive strength of ontology 1.
With reference to Figure 15, in surgical procedure, is introduced from 1 leading end of ontology, first with instrument then pyramidal support will be filled into nothing
Machine bone cement or sclerotin are hollow interior to waist Invasive lumbar fusion device, in level angle push-in centrum gap.
Embodiment 4
The present embodiment is approximate with embodiment 1, and structure is identical, only the material based on PLGA, and the nanometer of 30% mass fraction is added
Hydroxylapatite powder.
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 about 30% mass fraction nanometer hydroxyapatite powder, be sufficiently mixed about 1 hour, be cooled to 70 °
Disassembly cavity takes out material afterwards.Mixed material is cut into small pieces in the print chamber body for filling in 3D plotter with scissors,
It is arranged 140 degrees Celsius to preheat 30 minutes, is arranged 0.5 millimeter of interlayer piling height, printing and making cervical fusion device.
In terms of lumbar fusion cages data model, referring to Fig. 1-Fig. 7, mainly comprising main structure in half-moon-like in the present embodiment
Type hollow body 1, asymmetrical half-moon-shaped side are crossed to form sharp portion 10 as leading end by front and back arc, there is implantation to draw
The effect led is conducive to the implant surgery operation of lumbar fusion cages.Lumbar fusion cages ontology 1 is equipped with the bone grafting hole 2 of connection, plants
Bone hole 3 is located on the wall of two arcs of fusion device ontology 1.Bone grafting is inserted in bone grafting hole, can accelerate tissue and material
Speed is merged, new osteocyte is allowed to be packed into hollow cavity, enhances the effect of its fusion.
The upper and lower anti-slop serrations 4,8 that the upper and lower surfaces design of ontology 1 has fish scale-shaped to arrange, anti-slop serrations are the isosceles at 30 ° of angles
Triangle, this design can increase with lumbar vertebra contact surface, to increase the friction between instrument and lumbar vertebra, and be not easy
Deviate from Invasive lumbar fusion device from the lower end surface of upper lumbar spine centrum and the upper surface of lower lumbar spine centrum, can effectively merge hypocentrum
Structure.
The other side setting threaded hole 5 of lumbar fusion cages ontology 1 is used as operating side, after threaded hole 5 links surgical instrument,
The fulcrum of bone hammer operation insertion fusion device is provided, fusion device and vertebra are fixed.The surface of screw hole is plane, can be convenient
The installation of surgical instrument.
The top of 1 sharp portion 10 of ontology is provided with development needle 1, the upper surface of nearly sharp portion 10 is provided with development needle
27, for two development needles not in a plane, which is made by stainless steel material and is firmly inserted into ontology 1, grasps in operation
In work, under the irradiation of local X-ray, pilot pin plays the role of lumbar fusion cages and develops and position, and doctor's implantation position is prompted to be
It is no it is appropriate in place.
Ontology 1 is provided with the support of " M " font in central hollow region, to reinforce the compressive strength of ontology 1.
With reference to Figure 15, in surgical procedure, ontology 1 is implanted into centrum from sharp portion 10, first with instrument then pyramidal support will
It is hollow interior to waist Invasive lumbar fusion device to fill inorganic-bone cement or sclerotin, in level angle push-in centrum gap.
Embodiment 5
By PLGA (200,000 molecular weight), be cut into small pieces shape, fills in the print chamber body of 3D plotter, 140 degrees Celsius of preheatings, layer
Between 0.5 millimeter of piling height, 3D printing make lumbar intervertebral fusion device.
It mainly include main structure in class half referring to Fig. 8-Figure 14, in the present embodiment in terms of lumbar fusion cages data model
Month type hollow body 1 ' surrounds internal cavities by front arc wall, rear arc wall, the upper and lower planar wall of two sections of different radians, non-right
The half-moon-shaped side the last period front arc wall claimed intersects the sharp portion 10 ' constituted with rear arc wall as guide portion, has implantation
The effect of guidance is conducive to the implant surgery operation of lumbar fusion cages.Lumbar fusion cages ontology 1 ' is equipped with the forward and backward plant of connection
Bone hole 2 ', 3 ' is located at another front arc wall of ontology 1 ', on rear arc wall.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.
The upper and lower anti-slop serrations 4 ', 8 ' that the upper and lower surfaces design of lumbar fusion cages ontology 1 ' has fish scale-shaped to arrange, anti-slop serrations
For the isosceles triangle at 30 ° of angles, this design can increase with lumbar vertebra contact surface, to increase between instrument and lumbar vertebra
Friction, and be not easy to make Invasive lumbar fusion device to deviate from from the lower end surface of upper lumbar spine centrum and the upper surface of lower lumbar spine centrum, can be effective
Fusion up and down vertebral body structure.
Corresponding with sharp portion 10 ', the other side setting threaded hole 5 ' of ontology 1 ' is used as operation portion, takes over through 5 ' chain of threaded hole
After art instrument, the fulcrum of bone hammer operation insertion fusion device is provided, fusion device and vertebra are fixed.The surface of threaded hole 5 '
For plane, the installation of surgical instrument can be facilitated.
There are development needle one 6 ', 10 ' top of sharp portion in the upper surface of 1 ' two section of front arc wall junction of lumbar fusion cages ontology
Development needle 27 ' is set, and development needle is made by stainless steel material and is firmly inserted into ontology 1, in surgical procedure, local X-ray
Whether under irradiation, pilot pin plays the role of lumbar fusion cages and develops and position, prompt doctor's implantation position appropriate in place.
Lumbar fusion cages ontology 1 ' is provided with upper and lower " M " font in central hollow region and supported for 91 ', 92 ' ', to reinforce this
The compressive strength of body 1 '.
With reference to Figure 15, in surgical procedure, ontology 1 ' is implanted into centrum from sharp portion 10 ', first with instrument by pyramidal support, then
It is hollow interior to waist Invasive lumbar fusion device that inorganic-bone cement or sclerotin will be filled, in level angle push-in centrum gap.
Embodiment 6
The present embodiment is approximate with embodiment 5, and structure is identical, only the material based on PLGA, and the nanometer of 10% mass fraction is added
Hydroxylapatite powder.
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 about 10% mass fraction nanometer hydroxyapatite powder, be sufficiently mixed about 1 hour, be cooled to 70 °
Disassembly cavity takes out material afterwards.Mixed material is cut into small pieces in the print chamber body for filling in 3D plotter with scissors,
It is arranged 140 degrees Celsius to preheat 30 minutes, is arranged 0.5 millimeter of interlayer piling height, printing and making cervical fusion device.
1 ' structure of lumbar fusion cages ontology is same as Example 5.
With reference to Figure 15, in surgical procedure, ontology 1 ' is implanted into centrum from sharp portion 10 ', first with instrument by pyramidal support, then
It is hollow interior to waist Invasive lumbar fusion device that inorganic-bone cement or sclerotin will be filled, in level angle push-in centrum gap.
Embodiment 7
The present embodiment is approximate with embodiment 5, and structure is identical, only the material based on PLGA, and the nanometer of 20% mass fraction is added
Hydroxylapatite powder.
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.
1 ' structure of lumbar fusion cages ontology is same as Example 5.
With reference to Figure 15, in surgical procedure, ontology 1 ' is implanted into centrum from sharp portion 10 ', first with instrument by pyramidal support, then
It is hollow interior to waist Invasive lumbar fusion device that inorganic-bone cement or sclerotin will be filled, in level angle push-in centrum gap.
Embodiment 8
The present embodiment is approximate with embodiment 5, and structure is identical, only the material based on PLGA, and the nanometer of 30% mass fraction is added
Hydroxylapatite powder.
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.
1 ' structure of lumbar fusion cages ontology is same as Example 5.
With reference to Figure 15, in surgical procedure, ontology 1 ' is implanted into centrum from sharp portion 10 ', first with instrument by pyramidal support, then
It is hollow interior to waist Invasive lumbar fusion device that inorganic-bone cement or sclerotin will be filled, in level angle push-in centrum gap.
Claims (10)
1. the preparation method of the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of a kind of semilune 3D printing, using 3D printing skill
Art, which is characterized in that waist 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 is as filler material 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 degrees Celsius,
Nanometer hydroxyapatite powder is added by several times, is sufficiently mixed 1 hour, 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 fusion device model:
Using finite element human body lumbar vertebrae true model as design considerations, using CAD software editor's finite element model, stl mark is saved as
Quasi- file, and not closed edge is repaired to improve the adaptive data model of lumbar fusion cages;
(3) waist Invasive lumbar fusion device is prepared using 3D plotter biometric print machine fusion sediment.
2. the preparation method of the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of half-moon-shaped 3D printing according to claim 1,
It is characterized in that, the granular size of HAp described in step (1) is 200-400nm.
3. a kind of PLGA/ hydroxyapatite waist for the half-moon-shaped 3D printing that preparation method according to claim 1 or claim 2 obtains
Invasive lumbar fusion device, which is characterized in that lumbar fusion cages are irregular semilune hollow body, and corner is in round and smooth by chamfering
Shape at least surrounds internal cavities by front and back arcwall and lower planes wall, reinforcing rib is equipped in cavity, the side of ontology is in point
Sharp portion is as leading-in end;Ontology is equipped with the bone grafting hole symmetrically penetrated through, is located on the front and back arcwall of fusion device ontology, plants
Bone grafting is inserted in bone hole;Upper and lower surfaces are parallel planar structures, the anti-slop serrations that design has fish scale-shaped to arrange;The other side of ontology
Threaded hole is set, and the surface of the threaded hole is plane, after connecting surgical instrument as operating side, provides bone hammer operation insertion fusion
The fulcrum of device, fusion device and vertebra are fixed;The aobvious of the angle of cut is mutually at the top of ontology sharp portion and upper and lower surfaces setting
Shadow needle, development needle is made by stainless steel material and is firmly inserted into ontology, in surgical procedure, under the irradiation of local X-ray, and positioning
Needle plays the role of lumbar fusion cages and develops and position.
4. the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of half-moon-shaped 3D printing, feature exist according to claim 3
In the anti-slop serrations are the isosceles triangle at 30 ° of angles.
5. the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of half-moon-shaped 3D printing, feature exist according to claim 3
In the reinforcing rib is the reinforcing rib of " M " font, is located in Body Lumen and is divided into two M type reinforcing ribs up and down, " M " type
Five fulcrums support the arcwall inner wall equipped with bone grafting hole respectively.
6. according to the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of the half-moon-shaped 3D printing of claim 3 or 5, feature
It is, the bone grafting hole is ellipse.
7. the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of half-moon-shaped 3D printing, feature exist according to claim 3
In the threaded hole is countersunk head threaded hole.
8. the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of half-moon-shaped 3D printing, feature exist according to claim 3
In fusion device ontology is provided with auxiliary positioning hole on the top of upper and lower wall and sharp portion.
9. the PLGA/ hydroxyapatite waist Invasive lumbar fusion device of half-moon-shaped 3D printing, feature exist according to claim 8
In the development needle is fixed on the positioning hole.
10. a kind of PLGA/ hydroxyapatite waist intervertebral fusion according to any one of the claim 3-9 half-moon-shaped 3D printing
Application of the device in the treatment of waist intervertebral.
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