CN104758042A - Bone screw of three-dimensional through porous structure - Google Patents

Bone screw of three-dimensional through porous structure Download PDF

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Publication number
CN104758042A
CN104758042A CN201510188874.9A CN201510188874A CN104758042A CN 104758042 A CN104758042 A CN 104758042A CN 201510188874 A CN201510188874 A CN 201510188874A CN 104758042 A CN104758042 A CN 104758042A
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China
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screw
bone screw
porous
dimensional
bone
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尹博
吴志宏
张国伟
邱贵兴
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/866Material or manufacture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2420/00Materials or methods for coatings medical devices

Abstract

The invention discloses a bone screw of a three-dimensional through porous structure. The porous bone screw comprises a screw head, a screw body and a screw cap. The screw body comprises a porous network composed of the three-dimensional through porous structure. The porous bone screw is made of medical materials which can be implanted into a human body, the three-dimensional through porous structure of the porous bone screw provides more space for the growth of bone cells, the combination between the implanted screw and the bone tissues of the human body is promoted, and the anchoring can be firm.

Description

A kind of bone screw with three-dimensional through loose structure
Technical field
The invention belongs to technical field of medical instruments, relate to a kind of porous bone screw, be specifically related to a kind of porous bone screw with three-dimensional through hole structure.This porous bone screw can be applicable in clinical osseous tissue injury repairing.
Background technology
Along with being on the rise of aging, increasing with bone amount decline, bone microstructure degeneration, bone fragility, osteoporosis disease (osteoporosis, OP that fracture is basic feature easily occur appears after arriving person in middle and old age in increasing people.According to statistics, the whole world is existing about has 200,000,000 people to suffer from osteoporosis, and its sickness rate has leapt to world's commonly encountered diseases the 7th, is one of the most common disease of middle-aged and elderly people.China has been the country that sufferers of osteoporosis face is maximum in the world, international osteoporosis foundation and China's Healthy promote that " osteoporosis prevents and treats Chinese white paper " that foundation is issued for 2008 jointly points out, China has 9,000 ten thousand sufferers of osteoporosis face at present, accounts for 7.1% of total population.Sufferers of osteoporosis face is easily fractured, be common in spinal column, hip joint and extremity etc., and because screw is to the hold deficiency of bone, the postoperative second operation often occurring screw loosening, move back nail and cause thus of sufferers of osteoporosis face, bring huge body and mind puzzlement to doctor and patient, its high medical expense brings heavy financial burden also to patient and society.
The method of current raising screw-bone interface stability mainly contains: (1) cement augmentation technology, as adopted polymethyl methacrylate (PMMA) bone cement material, screw nail road is strengthened, but the method easily causes surrounding bone, neural tissue injury because bone cement solidifies heat release, and PMMA Biocompatibility is poor, hinder osseous tissue to grow into material, interface loosely; And bone cement seepage easily causes the serious complication of nerve, breathing and cardiovascular system; Meanwhile, this type of technology is high to doctor's operation requirements, once occur bone cement to solidify and implantation position is undesirable, again overhauls and will face huge challenge.Develop the method for hollow side opening pedicle screw associating bone cement perfusion on this basis, but in this technology the effective using dosage of bone cement and seepage dosage very close, PMMA dosage can significantly improve the stability of screw when being greater than 1.5mL, and dosage about has 33% patient that seepage occurs when 2.02 ± 0.56mL, therefore this technology needs careful operation, and this technology still can not avoid aforementioned various bone cement nail road reinforcement technique institutes problems faced.(2) improvement of screw itself, mainly contain the length and diameter that change screw, change the out of shape of screw thread, tip of screw be designed to expandable structure and give screw biological coating etc., but above-mentioned various method still cannot solve the problems such as unbalance stress (excessive or too small), contact interface knitting, and high to operation technical requirement, easily cause secondary fracture, important organ blood vessel as other in vertebral body, spinal nerves root is intraspinal tube spinal cord injury even.In sum, the improvement opportunity of current various screws still can not meet the needs of sufferers of osteoporosis face clinically.
Summary of the invention
In order to address the deficiencies of the prior art, the invention provides a kind of bone screw with three-dimensional through loose structure.The loose structure of screw is interconnected, allow that area of new bone is grown into screw inside, realize grappling biology of screw-bone interface, greatly improve screw to the hold of bone, screw loosening after can effectively preventing fixation, move back the generation of nail, there is good clinical value.
The invention provides a kind of bone screw with three-dimensional through loose structure, comprise ailhead, rivet nut, the head of a nail; Described rivet nut comprises the porous network of three-dimensional through hole Structure composing; The aperture of described porous network is 200 μm-900 μm or 1100 μm-2500 μm, and porosity is 78%-92%.The advantage in above-mentioned aperture is adopted to be: to provide that porous is communicated with, high porosity and enough Bone Ingrowth amounts, to meet clinical needs.
Preferably, the aperture of described porous network is 600 μm.
Preferably, the porosity of described porous network is 80%.
Further, described rivet nut also can comprise central entity, and described porous network is positioned at the outside of described central entity.In a specific embodiments of the present invention, described porous network is independent of described central entity surface and around described central entity.In another specific embodiments of the present invention, described porous network is the porous area formed on the surface in described central entity.
Further, described rivet nut also can comprise the helicitic texture on the porous network surface being positioned at three-dimensional through hole Structure composing.
Further, the hole shape of described porous network includes but not limited to polyhedron, spheroid, irregularly shaped.
Preferably, described polyhedron is regular dodecahedron, and the advantage of the pore structure of employing regular dodecahedron shape is: the multistage pore space structure that regular dodecahedron can provide porous to be communicated with, is beneficial to the adhesion of early stage cell, propagation, and has good mechanical stability.
Further, the raw materials of described porous bone screw can be non-degradable material, also can be degradation material.The raw materials of described porous bone screw includes but not limited to: the medical metal material in human implantable, bioceramic, medical macromolecular materials.
Preferably, described medical metal material is titanium alloy.
Further, the diameter range of described rivet nut is: 2-8mm.
Further, the cross sectional shape of described rivet nut is multiple: circle, ellipse, triangle, square, polygon, rivet nut length range is: 1-10cm.
Further, the described head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.
Porous bone screw surface of the present invention can cover biological coating, promotes integration and the growth of bone further.These biological coatings include but not limited to: hydroxyapatite coating layer, calcium titanate coating, titanium coating, titanium and hydroxyapatite meet active coating, the Afluon (Asta)/fluor-apatite composite coating of coating, wollastonite coating, hydroxyapatite and diphosphonate composite material.
The three-dimensional through hole body structure surface of porous bone screw of the present invention can adhere to decorative material, and induction osteocyte is grown into.Described decorative material includes but not limited to: natural polymer derived material, as collagen, fibrin, chitosan; Cell growth factor, as bone morphogenetic protein (BMP), basic fibroblast growth factor (bFGF), PDGF, VEGF; Poly-D-lysine; Polypeptides matter.
Above-mentioned biological coating and decorative material also can Application of composite, the integration of dual promotion bone and growth.
Porous bone screw of the present invention can adopt 3D printing technique to be prepared from, and making step is: (1) carries out the three dimensional design modeling of the porous bone screw with loose structure in computer; (2) metal quick molding method is utilized directly to generate finished product by metal dust.Described metal dust is preferably titanium alloy (Ti6Al4V).
The metal quick molding method that the present invention adopts is lf method, utilizes the method to prepare the concrete steps of porous bone screw of the present invention as follows:
1) by proe Three-dimensional Design Software, set up the threedimensional model of porous matrix structure construction unit in a computer, construction unit key element, porosity, aperture size are set;
2) according to step 1) in three-dimensional construction unit, by magics Three-dimensional Design Software with construction unit filling, expansion screw core, screw core is generated as porous matrix structure;
3) according to step 2) in threedimensional model, adopt Concept laser Mlab metal material 3D printer, print screw;
4) by step 3) after the printing screw that obtains heat-treats, cool to room temperature;
5) by step 4) the printing screw that obtains adopts Linear cut, cuts from work platforms;
6) by step 5) the printing screw that obtains adopts blasting treatment, and removing print surface glues molten unnecessary raw material;
7) by step 6) the printing screw that obtains adopts ultrasonic waves for cleaning, removing surface impurity;
8) above-mentioned screw is put into Epoxyethane sterilizing box and carry out sterilizing, independent subpackage process.
Further, the technological process of described step 3 is as follows: the titanium alloy powder adopting 10 ~ 60 μm of normal distributions, and product is printed thickness and is set to 0.015 ~ 0.05mm, edge compensation is set to 0.02 ~ 0.08mm; Support that printing thickness is set to 0.015 ~ 0.05mm; Additional outlines arranges inside or outside 1-5, and distance is set to 0.02 ~ 0.1mm; Adopt island pattern, XY direction size is set to 0.5 ~ 10mm, and angle is 0 ~ 180 degree, and XY side-play amount is 0 ~ 5mm.
Further, the detailed process flow of described step 4 is as follows: by step 3) the printing screw that obtains heat-treats, under argon shield condition; 840 degree are warmed up in 4 hours; keep 2 hours, in stove, be then cooled to 500 degree of taking-ups, naturally cool to room temperature.
Present invention also offers the application of above-mentioned porous bone screw in the material of preparation reparation osseous tissue damage.Be generally used for Fracture internal fixaiion, internal fixation of spine, prosthese hold-down screw.
Advantage of the present invention and beneficial effect as follows:
(1) titanium alloy has good biocompatibility, is a kind of good embedded material; Can reasonably be designed the mechanical property of porous titanium alloy screw by the parameter such as porosity, pore size, pore-size distribution, space pattern that controls porous titanium alloy screw and mate, make it, in the bone of human body different parts, there is suitable mechanical property.
(2) hole of porous bone screw of the present invention is three-dimensional through hole structure, and aperture is 200 μm-900 μm or 1100 μm-2500 μm, and porosity is 78%-92%.This pore structure and feature meet the requirement of Bone Ingrowth completely, are conducive to the transmission that body fluid is implanting.Osteoblast can be made to adhere to, break up and growth, allow osseous tissue to grow in the hole of porous bone screw simultaneously, bone-implant interfacial area is increased greatly, in addition the machinery between bone and loose structure is embedding to be acted on, make to form biological fixation between implant and osseous tissue, improve implant-bone interface bond strength.
(3) porous bone screw of the present invention can coordinate the use of the adsorbable bone cement such as calcium phosphate, calcium sulfate, hydroxyapatite, is filled in by this type of material in porous bone screw hole, thus promotes integration and the growth of bone further.
(4), compared with conventional with this area 3D printing technique parameter, the technological parameter preparing porous bone screw of the present invention employing substantially increases the precision of finished product.
Accompanying drawing explanation
Fig. 1 shows the structure chart had by the porous network of three-dimensional through hole Structure composing and the porous bone screw of helicitic texture; A: overall diagram, B: sectional view;
Fig. 2 display has by the structure chart of the porous bone screw of the porous network of three-dimensional through hole Structure composing; A: overall diagram, B: sectional view;
Fig. 3 shows the structure chart had by the porous network of three-dimensional through hole Structure composing and the porous bone screw of central entity; A: overall diagram, B: sectional view;
Fig. 4 display has by the structure chart of the porous bone screw of the porous network of three-dimensional through hole Structure composing, central entity and helicitic texture; A: overall diagram, B: sectional view.
Detailed description of the invention
Be described further below in conjunction with the concrete enforcement of accompanying drawing to porous bone screw of the present invention.
Embodiment 1 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail; Rivet nut is made up of the porous network of three-dimensional through hole Structure composing; Pore size is 200 μm, porosity is 78%.Shaft diameter scope is: 2mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, rivet nut length range is: 1cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.
Embodiment 2 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail; Rivet nut is made up of with the screw thread being positioned at porous network surface the porous network of three-dimensional through hole Structure composing; Pore size is 600 μm, and porosity is 80%, and the diameter of rivet nut is 5mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, rivet nut length 5cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The hole shape of porous network is polyhedron, spheroid or irregularly shaped.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.
Embodiment 3 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail; Rivet nut is made up of the porous network of central entity with the three-dimensional through hole Structure composing being positioned at central entity outside; Porous network is independent of central entity surface and around central entity.The pore size of three-dimensional through hole structure is 900 μm, and porosity is 92%, and the diameter of rivet nut is 8mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, and rivet nut length model is 10cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The hole shape of porous network is polyhedron, spheroid or irregularly shaped.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.
Embodiment 4 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail; Rivet nut is made up of central entity, the porous network being positioned at the three-dimensional through hole Structure composing of central entity outside and the screw thread be positioned on porous network surface; Porous network is independent of central entity surface and around central entity.The pore size of three-dimensional through hole structure is 1100 μm, and porosity is 78%; The diameter of rivet nut is 3mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, and rivet nut length is 3cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The hole shape of porous network is polyhedron, spheroid or irregularly shaped.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.
Embodiment 5 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail, the decorative material be positioned on rivet nut surface; Described rivet nut is made up of central entity, the porous network being positioned at the three-dimensional through hole Structure composing of central entity periphery and the screw thread be positioned on porous network surface; Porous network is independent of central entity surface and around central entity; Decorative material is attached on screw thread and/or is attached on the Kong Zhu of loose structure.The pore size of three-dimensional through hole structure is 1500 μm, and porosity is 80%, and the diameter of rivet nut is 7mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, and rivet nut length is 9cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The hole shape of porous network is polyhedron, spheroid or irregularly shaped.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.Decorative material includes but not limited to: natural polymer derived material, as collagen, fibrin, chitosan; Cell growth factor, as bone morphogenetic protein (BMP), basic fibroblast growth factor (bFGF), PDGF, VEGF; Poly-D-lysine; Polypeptides matter.
Embodiment 6 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail, the decorative material be positioned on rivet nut surface; Described rivet nut is made up of central entity, the porous network being positioned at the three-dimensional through hole Structure composing of central entity periphery and the screw thread be positioned on porous network surface; Porous network is independent of central entity surface and around central entity; Decorative material is attached on screw thread and/or is attached on the Kong Zhu of loose structure.The pore size of three-dimensional through hole structure is 2000 μm, and porosity is 85%, and the diameter of rivet nut is 7mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, and rivet nut length is 9cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The hole shape of porous network is polyhedron, spheroid or irregularly shaped.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.Decorative material includes but not limited to: natural polymer derived material, as collagen, fibrin, chitosan; Cell growth factor, as bone morphogenetic protein (BMP), basic fibroblast growth factor (bFGF), PDGF, VEGF; Poly-D-lysine; Polypeptides matter.
Embodiment 7 one kinds has the bone screw of three-dimensional through loose structure
Have a bone screw for three-dimensional through loose structure, this porous bone screw is made up of ailhead, rivet nut, the head of a nail, the decorative material be positioned on rivet nut surface; Described rivet nut is made up of central entity, the porous network being positioned at the three-dimensional through hole Structure composing of central entity periphery and the screw thread be positioned on porous network surface; Porous network is independent of central entity surface and around central entity; Decorative material is attached on screw thread and/or is attached on the Kong Zhu of loose structure.The pore size of three-dimensional through hole structure is 2500 μm, and porosity is 92%, and the diameter of rivet nut is 7mm.The cross sectional shape of rivet nut is multiple: circle, ellipse, triangle, square, polygon, and rivet nut length is 9cm.The head of a nail is entity structure, and cross sectional shape is multiple: can be circle, oval, square, triangle, polygon.The hole shape of porous network is polyhedron, spheroid or irregularly shaped.The raw materials of porous bone screw is medical metal material, bioceramic, medical macromolecular materials in human implantable.Medical metal material includes but not limited to titanium, titanium alloy.Decorative material includes but not limited to: natural polymer derived material, as collagen, fibrin, chitosan; Cell growth factor, as bone morphogenetic protein (BMP), basic fibroblast growth factor (bFGF), PDGF, VEGF; Poly-D-lysine; Polypeptides matter.
The preparation method of embodiment 8 porous bone screw
The present embodiment uses 3D printing technique, is that the porous bone screw described in embodiment 1-8 prepared by raw material with titanium alloy.Concrete operation step is as follows:
1) by proe Three-dimensional Design Software, set up the threedimensional model of porous matrix structure construction unit in a computer, build the construction unit key element that volume XYZ direction is 0.5 ~ 5mm, arranging pore size is 0.25 ~ 5mm, and porosity is 78-92%;
2) according to step 1) in three-dimensional construction unit, by magics Three-dimensional Design Software with construction unit filling, expansion screw core, screw core is generated as porous matrix structure;
3) according to step 2) in threedimensional model, adopt Concept laser Mlab metal material 3D printer, print screw.Technique conditional optimum configurations is as follows: the titanium alloy powder adopting 10 ~ 60 μm of normal distributions, and product is printed thickness and is set to 0.015 ~ 0.05mm, edge compensation is set to 0.02 ~ 0.08mm; Support that printing thickness is set to 0.015 ~ 0.05mm; Additional outlines arranges inside or outside 1-5, and distance is set to 0.02 ~ 0.1mm; Adopt island pattern, XY direction size is set to 0.5 ~ 10mm, and angle is 0 ~ 180 degree, and XY side-play amount is 0 ~ 5mm, and other conditional parameters are conveniently arranged;
4) by step 3) the printing screw that obtains heat-treats, under argon shield condition, is warmed up to 840 degree in 4 hours, keeps 2 hours, in stove, be then cooled to 500 degree of taking-ups, naturally cool to room temperature;
5) by step 4) the printing screw that obtains adopts Linear cut, cuts from work platforms;
6) by step 5) the printing screw that obtains adopts blasting treatment, and removing print surface glues molten unnecessary raw material;
7) by step 6) the printing screw that obtains adopts ultrasonic waves for cleaning, removing surface impurity;
8) above-mentioned screw is put into Epoxyethane sterilizing box and carry out sterilizing, independent subpackage process.
For the remarkable technique effect of the machined parameters generation that the checking embodiment of the present invention provides, inventors performed detailed contrast experiment.Concrete correction data is as shown in table 1.
Comparing of the technique effect that the machined parameters of table 1 the present embodiment obtains with conventional machining parameter
The aperture of the three-dimensional through hole arranged 200 600 900 1100 2500
Effective aperture under conventional machining parameter 162 488 732 896 2049
Effective aperture under optimizing machining technology parameter 198±8 596±17 894±24 1092±28 2413±31
Note: conventional machining parameter refers to machined parameters conventional in prior art, and the aperture value in table is the aperture average of the porous bone screw using the different conventional machining parameter of many groups to process; Optimizing machining technology parameter refers to the machined parameters that the embodiment of the present invention provides, corresponding aperture value is the aperture average of the porous bone screw using the different optimizing machining technology parameter of many groups to process, meanwhile, also show the error amount in the aperture under optimizing machining technology parameter in table.
From experimental result, at least from aperture this numerically, the aperture of the porous bone screw using the machined parameters that provides of the embodiment of the present invention to process is more close to the aperture of target three-dimensional, and precision provide at least 10%.
The performance of embodiment 9 porous bone screw
According to document (SL.Zhua et al.Effect of porous NiTi alloy on bone formation:acomparative investigation with bulk NiTi alloy for 15weeks in vivo, materalsscience and engineering C, 2008,28 (8): 1271-1275; Liu binds, porous titanium alloy pore size on the impact of new bone formation, master thesis) in the step that describes set up femur injury model, the situation of growing into of new bone after observing the porous bone screw implanting different porosities.Constant aperture is 600 μm, and prepare the porous bone screw of different porosities according to the method for preceding embodiment, porosity is respectively 35%, 50%, 77%, 78%, 79%, 80%, 82%, 85%, 90%, 92%, 93%, 94%.Result shows, after porous bone screw within the scope of porosity 78%-92% is implanted, compared with the porous bone screw of other porositys, Bone Ingrowth amount is many, the bond strength at bone and screw material interface is strong, angiogenic growth amount is many.And the porous bone screw that porosity is 80% causes injury repairing effect best.
According to document (SL.Zhua et al.Effect of porous NiTi alloy on bone formation:acomparative investigation with bulk NiTi alloy for 15weeks in vivo, materals scienceand engineering C, 2008,28 (8): 1271-1275; Liu binds, porous titanium alloy pore size on the impact of new bone formation, master thesis) in the step that describes set up femur injury model, the situation of growing into of new bone after observing the porous bone screw implanting different pore size.Permanent porosity is 80%, prepare the porous bone screw of different pore size according to the method for preceding embodiment, pore size is respectively 10 μm, 30 μm, 50 μm, 100 μm, 200 μm, 300 μm, 500 μm, 600 μm, 800 μm, 900 μm, 1000 μm, 1100 μm, 1200 μm, 1500 μm, 2000 μm, 2500 μm, 2700 μm, 3000 μm.Result shows, after the porous bone screw of aperture within the scope of 200 μm-900 μm and 1100 μm-2500 μm is implanted, compared with the porous bone screw in other apertures, Bone Ingrowth amount is many, the bond strength at bone and screw material interface is strong, angiogenic growth amount is many.And the porous bone screw that aperture is 600 μm causes injury repairing effect best.
The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.

Claims (10)

1. have a bone screw for three-dimensional through loose structure, it is characterized in that, described bone screw bag expands draws together ailhead, rivet nut, the head of a nail; Described rivet nut comprises the porous network of three-dimensional through hole Structure composing; The aperture of described porous network is 200 μm-900 μm or 1100 μm-2500 μm, and porosity is 78%-92%.
2. bone screw according to claim 1, is characterized in that, described rivet nut comprises central entity, and described porous network is positioned at the outside of described central entity.
3. bone screw according to claim 2, is characterized in that, described porous network is independent of described central entity surface and around described central entity.
4. bone screw according to claim 2, is characterized in that, described porous network is the porous area generated on the surface in described central entity.
5. the bone screw according to any one of claim 1-4, is characterized in that, described rivet nut comprises the screw thread be positioned on described porous network surface.
6. the bone screw according to any one of claim 1-4, is characterized in that, the hole shape of described porous network is polyhedron, spheroid or irregularly shaped.
7. bone screw according to claim 6, is characterized in that, described polyhedron is regular dodecahedron.
8. a preparation method for bone screw according to claim 1, is characterized in that, the concrete steps of described preparation method are as follows:
1) by proe Three-dimensional Design Software, set up the threedimensional model of porous matrix structure construction unit in a computer, construction unit key element, porosity, aperture size are set;
2) according to step 1) in three-dimensional construction unit, by magics Three-dimensional Design Software with construction unit filling, expansion screw core, screw core is generated as porous matrix structure;
3) according to step 2) in threedimensional model, adopt Concept laser Mlab metal material 3D printer to print screw;
4) by step 3) the printing screw that obtains heat-treats rear cool to room temperature;
5) by step 4) the printing screw that obtains adopts Linear cut, cuts from work platforms;
6) by step 5) the printing screw that obtains adopts blasting treatment, and removing print surface glues molten unnecessary raw material;
7) by step 6) the printing screw that obtains adopts ultrasonic waves for cleaning, removing surface impurity;
8) above-mentioned screw is put into Epoxyethane sterilizing box and carry out sterilizing, independent subpackage process.
9. preparation method according to claim 8, it is characterized in that, being set to of the technological process conditional parameter of described step 3: the titanium alloy powder adopting 10 ~ 60 μm of normal distributions, product is printed thickness and is set to 0.015 ~ 0.05mm, edge compensation is set to 0.02 ~ 0.08mm; Support that printing thickness is set to 0.015 ~ 0.05mm; Additional outlines arranges inside or outside 1-5, and distance is set to 0.02 ~ 0.1mm; Adopt island pattern, XY direction size is set to 0.5 ~ 10mm, and angle is 0 ~ 180 degree, and XY side-play amount is 0 ~ 5mm.
10. bone screw according to claim 1 repairs the application in the material of osseous tissue damage in preparation.
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CN105686875A (en) * 2016-03-19 2016-06-22 傅山泓 Personalized bone plate and manufacturing method thereof
CN105903084A (en) * 2016-04-15 2016-08-31 华中科技大学 3D printing porous scaffold with antibacterial functional coating and preparation method thereof
CN105903084B (en) * 2016-04-15 2019-04-12 华中科技大学 A kind of 3D printing porous support and preparation method thereof with antibacterial functions coating
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CN107252342A (en) * 2017-01-17 2017-10-17 吴栋 A kind of acetabular bone screw and preparation method thereof
CN106725941A (en) * 2017-02-24 2017-05-31 徐斌 Fixed planting body of taking root can be irrigated
CN107790719A (en) * 2017-11-13 2018-03-13 成都优材科技有限公司 Based on selective laser molten metal fine cellular structure forming method
CN108052774A (en) * 2018-01-03 2018-05-18 河北工业大学 A kind of preparation method of double-layer structure bone screws
CN108052774B (en) * 2018-01-03 2021-04-27 河北工业大学 Preparation method of bone screw with double-layer structure
US10575886B2 (en) 2018-05-09 2020-03-03 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US10993753B2 (en) 2018-05-09 2021-05-04 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
US11191582B2 (en) 2018-05-09 2021-12-07 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
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US11857233B2 (en) 2018-05-09 2024-01-02 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
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