CN110368522A - A kind of artifical bone and preparation method thereof - Google Patents

A kind of artifical bone and preparation method thereof Download PDF

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Publication number
CN110368522A
CN110368522A CN201810332403.4A CN201810332403A CN110368522A CN 110368522 A CN110368522 A CN 110368522A CN 201810332403 A CN201810332403 A CN 201810332403A CN 110368522 A CN110368522 A CN 110368522A
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Prior art keywords
bone
artifical
artifical bone
main body
preparation
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CN110368522B (en
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陈梓煜
申超
何伟强
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Guangzhou Yangming New Material Technology Co Ltd
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Guangzhou Yangming New Material Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/12Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/32Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE 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
    • B33Y10/00Processes of additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00Materials specially adapted for additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE 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
    • B33Y80/00Products made by additive manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/112Phosphorus-containing compounds, e.g. phosphates, phosphonates
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
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  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
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  • Manufacturing & Machinery (AREA)
  • Biomedical Technology (AREA)
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  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The application belongs to medical instruments field more particularly to a kind of artifical bone and preparation method thereof.The present invention provides a kind of artifical bone, artifical bone's main body includes: hollow shell, marrow channel and bracket, and the marrow channel is set to the inside of the hollow shell, and the marrow channel is connect by the bracket with the hollow shell;The filled layer is filled in the gap between the hollow shell and the marrow channel.The present invention also provides the preparation methods of above-mentioned artifical bone a kind of.In technical solution provided by the invention, after artifical bone is implanted into the patient, under the action of body fluid, bone uptake activity articulamentum can induce the generation of new bone;Further, the new bone of generation can grow into the inside of artifical bone's main body, form three-dimensional interpenetrating structure, be conducive to the combination of artifical bone and patient itself bone, artifical bone is avoided to loosen, activity is more flexible;It solves in the prior art, after artifical bone is implanted into the patient, the technological deficiency that can not be merged very well with the bone of patient itself.

Description

A kind of artifical bone and preparation method thereof
Technical field
The application belongs to medical instruments field more particularly to a kind of artifical bone and preparation method thereof.
Background technique
Currently, causing the patient of bone defect more and more due to factors such as wound, infection, tumours, when bone defect gap It is excessive, it is difficult to when realizing self-heal, it is necessary to carry out Bone Defect Repari treatment;It is implanted into completely new artifical bone in defect, fills Gap caused by bone defect.
In the prior art, it after artifical bone is implanted into the patient, along with the daily routines of patient, can be sent out between Bones and joints Raw relative motion, in turn, the artifical bone of adjacent bone and implantation can rub.Meanwhile it being arranged in addition with the foreign matter of body Reprimand effect, the artifical bone of implantation can not be implanted into inconvenient activity at the corresponding joint of bone, have with the bone fusion of patient itself When, or even violent pain can be generated.
Therefore, a kind of artifical bone and preparation method thereof is developed, for solving in the prior art, artificial bone implant patient body After interior, the technological deficiency that can not be merged very well with the bone of patient itself becomes that those skilled in the art are urgently to be resolved to be asked Topic.
Summary of the invention
In view of this, the present invention provides a kind of artifical bone and preparation method thereof, for solving in the prior art, artifical bone After being implanted into the patient, the technological deficiency that can not be merged very well with the bone of patient itself.
The present invention provides a kind of artifical bone, the structure of the artifical bone are as follows: artifical bone's main body and filled layer, it is described artificial Bone main body includes: hollow shell, marrow channel and bracket, and the marrow channel is set to the inside of the hollow shell, institute Marrow channel is stated to connect by the bracket with the hollow shell;The filled layer is filled in the hollow shell and the bone In gap between marrow channel;
Artifical bone's main body is polyether-ether-ketone artifical bone main body, and the filled layer is bone uptake activity articulamentum.
Preferably, the volume of the filled layer accounts for the 5~60% of artifical bone's body volume.
Preferably, the surface of the artifical bone is provided with protective coating, and the protective coating is covered in the artifical bone master The surface of body;
The protective coating is hydroxyapatite coating layer.
Preferably, the active articulamentum are as follows: hydroxyapatite layer or hydroxyapatite composite layer;
The hydroxyapatite composite layer includes: hydroxyapatite and the broken bone of human body, bone meal and the bone cell activity factor In any one or more.
Preferably, the partial size of hydroxyapatite is less than 100nm.
The present invention also provides a kind of preparation method including one artifical bone of any of the above, the preparation methods Are as follows:
Step 1: data acquisition and modeling: acquisition both injured bones data prepare 3D bone model, the 3D according to the data Bone model is a hollow structure containing marrow channel, and hollow shell is connect with marrow channel by bracket;
Step 2: artifical bone's subject preparation: being prepared 3D bone model made from step 1 by the way of 3D printing artificial Bone main body;
Step 3: filled layer inject: by the hollow shell Yu marrow channel of artifical bone main body made from step 2 it Between interlayer infuse filled layer slurries, after solidification intermediate product;
Step 4: post-processing: intermediate product obtained by step 3 is successively thermally treated with after disinfection, obtains artificial bone product;
Wherein, in step 3, the filled layer is bone uptake activity articulamentum.
Preferably, the preparation method further include: coating spraying, the coating spraying step step 3 and step 4 it Between carry out;
The method of the coating spraying are as follows: in the surface spraying hydroxyapatite coating of the intermediate product, production must be sprayed Object, the spraying product continue the processing of step 4.
Preferably, in step 3, filled layer slurries the preparation method comprises the following steps: in terms of mass parts, 50~90 parts of hydroxyapatite, 10~50 parts of half-H 2 O calcium sulphate, 1~5 part of stearic acid and 50~100 parts of physiological saline mixing, obtain filled layer slurries.
Preferably, in step 3, filled layer slurries the preparation method comprises the following steps: in terms of mass parts, 50~90 parts of hydroxyapatite, 10~50 parts of half-H 2 O calcium sulphate, 1~5 part of stearic acid and 50~100 parts of physiological saline mixing, then with the broken bone of human body, bone meal with And any one or more total 50~100 parts of mixing in the bone cell activity factor, obtain filled layer slurries.
Preferably, in step 2, artifical bone's main body be hollow artifical bone's main body, artifical bone's main body with a thickness of 2~10mm.
In conclusion the present invention provides a kind of artifical bone, the structure of the artifical bone are as follows: artifical bone's main body and filling Layer, artifical bone's main body include: hollow shell, marrow channel and bracket, and the marrow channel is set to described hollow outer The inside of shell, the marrow channel are connect by the bracket with the hollow shell;The filled layer is filled in described hollow In gap between shell and the marrow channel;Artifical bone's main body is polyether-ether-ketone artifical bone main body, the filled layer For bone uptake activity articulamentum.The present invention also provides the preparation method of above-mentioned artifical bone a kind of, are as follows: data acquisition and modeling, Artifical bone's subject preparation, filled layer injection, post-processing;Wherein, in step 3, the filled layer is bone uptake activity articulamentum. In technical solution provided by the invention, after artifical bone is implanted into the patient, under the action of body fluid, bone uptake activity articulamentum can To induce the generation of new bone;Further, the new bone of generation can grow into the inside of artifical bone's main body, form three-dimensional interpenetrating knot Structure is conducive to the combination of artifical bone and patient itself bone, artifical bone is avoided to loosen, and activity is more flexible.It is provided by the invention A kind of artifical bone and preparation method thereof, solves in the prior art, can not be with patient's itself after artifical bone is implanted into the patient The technological deficiency that bone merges very well.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is only this The embodiment of invention for those of ordinary skill in the art without creative efforts, can also basis The attached drawing of offer obtains other attached drawings.
Fig. 1 is a kind of flow diagram of the preparation method of artifical bone provided by the invention;
Fig. 2 is a kind of structural schematic diagram of artifical bone provided by the invention;
Wherein, artifical bone's main body 1, bracket 11, marrow channel 12 and filled layer 2.
Specific embodiment
The embodiment of the invention provides a kind of artifical bones and preparation method thereof, and for solving in the prior art, artifical bone plants After entering patient's body, the technological deficiency that can not be merged very well with the bone of patient itself.
The technical scheme in the embodiments of the invention will be clearly and completely described below, it is clear that described implementation Example is only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, this field is common Technical staff's every other embodiment obtained without making creative work belongs to the model that the present invention protects It encloses.
In order to which the present invention is described in more detail, below with reference to embodiment to a kind of artifical bone provided by the invention and its preparation side Method is specifically described.
Referring to Fig. 2, the embodiment of the invention provides a kind of artifical bone, structure are as follows: artifical bone's main body and filled layer, it is artificial Bone main body includes: hollow shell, marrow channel and bracket, and marrow channel is set to the inside of hollow shell, and marrow channel is logical Bracket is crossed to connect with hollow shell;Filled layer is filled in the gap between hollow shell and marrow channel;Artifical bone's main body is Polyether-ether-ketone artifical bone's main body, filled layer are bone uptake activity articulamentum.A kind of artifical bone provided in an embodiment of the present invention and its Preparation method solves in the prior art, after artifical bone is implanted into the patient, can not merge very well with the bone of patient itself Technological deficiency.
In technical solution provided in an embodiment of the present invention, filled layer selects bone uptake activity articulamentum, by artificial bone implant After patient bone defect, since bone uptake activity articulamentum has good bioactivity and biocompatibility, in body fluid Under effect, Partial digestion can occur for filled layer, and the substance that dissociates after degradation can be absorbed and utilized by tissue, grow New tissue, to produce good bone conduction effect.The new bone that osteoacusis generates can grow into the inside of artifical bone's main body, With original bone and new bone formation three-dimensional interpenetrating structure, is conducive to the combination of artifical bone and patient itself bone, solves Artifical bone is implanted into the patient can not be with the technological deficiency of patient itself bone fusion;Further, artifical bone's loosening is avoided, Patient activity more freely, will not cause pain sense of discomfort due to rubbing between artifical bone and itself bone.
Second, during practical application, effectively to ensure that artifical bone has by enough rigidity and intensity, meanwhile, also It needs that there is enough surface smoothness, also, rejection will not be generated after the implantation, biocompatibility is good.The application In, artifical bone's main body is polyether-ether-ketone artifical bone main body.Polyether-ether-ketone artifical bone main body can meet all above-mentioned requirements, polyethers The elasticity modulus and people's bone of ether ketone artifical bone's main body are close.
Therefore, supporting role of the polyether-ether-ketone in structure, cooperation stimulate new bone to generate with bone uptake activity articulamentum Effect, after artifical bone is implanted into the patient, can both have enough intensity and rigidity, can also stimulate the production of new bone Raw, promotion area of new bone is merged with internal original bone.After artificial bone implant, foreign body sensation is unobvious, and activity flexibly, will not generate Feeling of pain.
Third, can be according to actual application demand, and according to the characteristic of be implanted into artifical bone, optional cavernous structure is through Artifical bone's main body is still only punched on surface, or is through the combination with surface punching;If moreover, in artifical bone's main body Surface punching, adjacent cavernous structure can also be the structure design that bottom communicates.Design in relation to cavernous structure, need to be according to plant The characteristic for entering position carries out personalized designs and belongs to those skilled in the art to the design of cavernous structure on the basis of the application Member is not required to make the creative labor what you can get it, and details are not described herein.
Further optimisation technique scheme had both been necessary to ensure that artifical bone's tool by enough intensity and rigidity, if being filled with The cavernous structure accounting of bone uptake activity articulamentum is excessive or single cavernous structure is excessive, then may result in the strong of artifical bone Degree and the insufficient either local strength of rigidity are insufficient;It is also desirable to ensure be implanted into artifical bone can with it is original in body Bone merge well, if the cavernous structure accounting filled with bone uptake activity articulamentum is too small or local aperture is too small, Then being possible to will lead to artifical bone and can not effectively merging either part well with the original bone of patient's body can not merge. Therefore, in a kind of artifical bone provided in an embodiment of the present invention.The volume of cavernous structure accounts for the 5~60% of artifical bone's body volume, The diameter of cavernous structure is 0.5~10mm.
For the bioactivity for further improving artificial bone surface, merged convenient for artifical bone with the bone of surrounding, this In the technical solution that inventive embodiments provide, the surface of artifical bone is provided with protective coating, and protective coating is covered in artifical bone master The surface of body;Protective coating is hydroxyapatite coating layer.
According to actual use demand, in use, be 10~100 μm by the thickness design of the protective coating, it both can be with The bioactivity of artificial bone surface is effectively improved, it can also be on the basis of ensuring active articulamentum good bioactivity, together When, it takes into account with active articulamentum property stabilization and low-cost design requirement, technical solution provided in an embodiment of the present invention In, active articulamentum are as follows: hydroxyapatite layer or hydroxyapatite composite layer;Hydroxyapatite composite layer includes: hydroxy-apatite Any one or more in stone and the broken bone of human body, bone meal and the bone cell activity factor.
According to the research to skeleton, the hydroxyapatite in body bone is mainly nanoscale whiskers structure, because This, is to realize the active better biology performance of articulamentum, in technical solution provided in an embodiment of the present invention, hydroxyapatite Partial size is less than 100nm.
Referring to Fig. 1, the embodiment of the invention also provides the preparation method of artifical bone a kind of, are as follows:
Step 1: data acquisition and modeling: acquisition both injured bones data prepare 3D bone model according to data, and in 3D bone mould Several cavernous structures are arranged in the surface of type.
According to the CT scan data or MRI scan data of skeletal sites to be implanted, imports MIMICS software and is handled, STL formatted file is exported, 3-MATIC software is imported the file into and carries out 3D modeling, establish the 3D model of artifical bone, export STL Formatted file.According to loading force suffered by human body different piece bone difference, 3D bone model hollow shell and marrow channel it Between several supporting structures are set.
Step 2: artifical bone's subject preparation: by the way of 3D printing by surface made from step 1 and marrow channel it Between be arranged several supporting structures 3D bone model preparation artifical bone's main body.
Since artifical bone needs to match with the bone of surrounding, the complexity of structure is very high, it is also desirable to It is preset with marrow channel at the center of artifical bone, so that the complexity of artificial bone structure is further promoted.For ensure can be with The complicated fine artifical bone of preparation, meanwhile, the waste of raw material during artifical bone's subject preparation is reduced, in the system of artifical bone's main body During standby, in technical solution provided by the invention, the preparation of artifical bone's main body is carried out by the way of 3D printing.
Step 3: filled layer injects: being filled being infused between the surface and marrow channel of artifical bone's main body made from step 2 Layer slurries, obtain intermediate product after solidification;Wherein, filled layer is bone uptake activity articulamentum.
Filled layer slurries the preparation method comprises the following steps: in terms of mass parts, 50~90 parts of hydroxyapatite, half-H 2 O calcium sulphate 10~50 Part, 1~5 part of stearic acid and 50~100 parts of physiological saline mixing, obtain filled layer slurries.
It, can also be in filled layer slurries for the bioactivity for further improving filled layer during practical application Middle addition promotes the substance of induction bone cell growth, and therefore, the optimization preparation method of filled layer slurries is the hydroxyl in terms of mass parts 50~90 parts of apatite, 10~50 parts of half-H 2 O calcium sulphate, 1~5 part of stearic acid and 50~100 parts of physiological saline mixing, then with Any one or more total 50~100 parts of mixing in the broken bone of human body, bone meal and the bone cell activity factor, obtains filled layer slurry Liquid.
In filled layer injection, since the partial size of filled layer is very little, can take needle tubing that filled layer is injected people It makes in the cavernous structure of bone body surfaces or other suitable modes, the method for implanting of filled layer belongs to those skilled in the art The common knowledge that member both knows about, details are not described herein.
Step 4: post-processing: intermediate product obtained by step 3 is successively thermally treated with after disinfection, obtains artificial bone product.
Through the heat treatment step, the stress that can eliminate or reduce artifical bone's interiors of products improves artificial bone product Mechanical property and biology performance.Specifically, process of thermal treatment can be 200~250 DEG C of temperature, 1~4h of time;It can basis Actual artificial bone structure's characteristic is finely adjusted, and details are not described herein.
Further, the preparation method of a kind of artifical bone provided in an embodiment of the present invention further include: coating spraying, the painting Layer spraying process carries out between step 3 and step 4;The method of the coating spraying are as follows: on the surface of the intermediate product Spraying hydroxyapatite coating, obtains spraying product, and the spraying product continues the processing of step 4.
For the weight that artifical bone is effectively reduced, mitigate the foreign body sensation after patient is implanted into, meanwhile, reduce the use of artifical bone's main body It measures, in step 2, obtained artifical bone's main body is hollow artifical bone's main body, and the surface layer thickness of artifical bone's main body is 2 ~10mm.Herein, further referring to Fig. 2, the centre of artifical bone's main body is provided with marrow channel, marrow channel is in The stability of morphosis is maintained between empty artifical bone's main body by bracket.
Further, cylindrical, square, triangle can be selected in bracket cross section shape between artificial bone surface and marrow channel The regular cross sectional shape such as shape can also select irregular section shape, intersection construction, space lattice etc., and design herein can root Change is made according to the concrete shape of artifical bone.
A kind of artifical bone provided by the invention and preparation method thereof is described further below in conjunction with embodiment.
Embodiment 1
The present embodiment is the specific embodiment for preparing artificial bone product 1.
A kind of artifical bone's preparation method the following steps are included:
Step 1: data acquisition and modeling
It is scanned using bone defect position of the high-precision CT to patient, obtains three-dimensional modeling data;It imports data to MIMICS software is handled, and STL formatted file is exported.It imports the file into 3-MATIC software and carries out 3D modeling, establish artificial The threedimensional model of bone exports STL formatted file.
Several supporting structures are set between the resulting artifical bone's body surfaces of 3D modeling and marrow channel, supporting structure The diameter that volume accounts for the 20% of artifical bone's main body, supporting structure is 5mm.
Step 2: artifical bone's subject preparation
Resulting STL formatted file is imported into FDM 3D printer and carries out 3D printing, 3D printing consumptive material selection diameter is The medical grade PEEK wire rod of 1.75mm.
Step 3: filled layer injects
In the hole that the hydroxyapatite mixture for configuring thick shape uses needle tubing to be rapidly injected on artifical bone.Thick shape hydroxyl The proportion of apatite composite are as follows: hydroxyapatite content is 90 parts, sulfate hemihydrate calcium content is 10 parts, stearic acid content 1 Part and physiological saline content are 100 parts.
Step 4: coating spraying
Using plasma spraying method spraying hydroxyapatite coating, wherein 20 microns of coating layer thickness.
Step 5: post-processing
Step 4 products therefrom is heat-treated, heat treatment process are as follows: 200 DEG C of temperature, time 4h, heat treatment are completed Afterwards, it carries out disinfection and properly saves.
Embodiment 2
The present embodiment is the specific embodiment for preparing artificial bone product 1.
A kind of artifical bone's preparation method the following steps are included:
Step 1: data acquisition and modeling
It is scanned using bone defect position of the high-precision CT to patient, obtains three-dimensional modeling data;It imports data to MIMICS software is handled, and STL formatted file is exported.It imports the file into 3-MATIC software and carries out 3D modeling, establish artificial The threedimensional model of bone exports STL formatted file.
Several supporting structures are set between the resulting artifical bone's body surfaces of 3D modeling and marrow channel, supporting structure The diameter that volume accounts for the 30% of artifical bone's main body, supporting structure is 6mm.
Step 2: artifical bone's subject preparation
Resulting STL formatted file is imported into FDM 3D printer and carries out 3D printing, 3D printing consumptive material selection diameter is The medical grade PEEK wire rod of 1.75mm.
Step 3: filled layer injects
In the hole that the hydroxyapatite mixture for configuring thick shape uses needle tubing to be rapidly injected on artifical bone.With mass parts Meter, the proportion of thick shape hydroxyapatite mixture are as follows: hydroxyapatite content is 80 parts, sulfate hemihydrate calcium content is 15 parts, hard Resin acid content is 2 parts, 50 parts of the broken bone of human body and bone meal mix and physiological saline content are 90 parts.
Step 4: coating spraying
Using plasma spraying method spraying hydroxyapatite coating, wherein 30 microns of coating layer thickness.
Step 5: post-processing
Step 4 products therefrom is heat-treated, heat treatment process are as follows: 220 DEG C of temperature, time 3h, heat treatment are completed Afterwards, it carries out disinfection and properly saves.
Embodiment 3
The present embodiment is the specific embodiment for preparing artificial bone product 1.
A kind of artifical bone's preparation method the following steps are included:
Step 1: data acquisition and modeling
It is scanned using bone defect position of the high-precision CT to patient, obtains three-dimensional modeling data;It imports data to MIMICS software is handled, and STL formatted file is exported.It imports the file into 3-MATIC software and carries out 3D modeling, establish artificial The threedimensional model of bone exports STL formatted file.
Several supporting structures are set between the resulting artifical bone's body surfaces of 3D modeling and marrow channel, supporting structure The aperture that volume accounts for the 40% of artifical bone's main body, cavernous structure is 7mm.
Step 2: artifical bone's subject preparation
Resulting STL formatted file is imported into FDM 3D printer and carries out 3D printing, 3D printing consumptive material selection diameter is The medical grade PEEK wire rod of 1.75mm.
Step 3: filled layer injects
In the hole that the hydroxyapatite mixture for configuring thick shape uses needle tubing to be rapidly injected on artifical bone.Thick shape hydroxyl The proportion of apatite composite are as follows: hydroxyapatite content is 70 parts, sulfate hemihydrate calcium content is 20 parts, stearic acid content 3 Part and physiological saline content are 90 parts.
Step 4: coating spraying
Using plasma spraying method spraying hydroxyapatite coating, wherein 40 microns of coating layer thickness.
Step 5: post-processing
Step 4 products therefrom is heat-treated, heat treatment process are as follows: 230 DEG C of temperature, time 2h, heat treatment are completed Afterwards, it carries out disinfection and properly saves.
Embodiment 4
The present embodiment is the specific embodiment for preparing artificial bone product 1.
A kind of artifical bone's preparation method the following steps are included:
Step 1: data acquisition and modeling
It is scanned using bone defect position of the high-precision CT to patient, obtains three-dimensional modeling data;It imports data to MIMICS software is handled, and STL formatted file is exported.It imports the file into 3-MATIC software and carries out 3D modeling, establish artificial The threedimensional model of bone exports STL formatted file.
Several supporting structures are set between the resulting artifical bone's body surfaces of 3D modeling and marrow channel, supporting structure The aperture that volume accounts for the 50% of artifical bone's main body, cavernous structure is 8mm.
Step 2: artifical bone's subject preparation
Resulting STL formatted file is imported into FDM 3D printer and carries out 3D printing, 3D printing consumptive material selection diameter is The medical grade PEEK wire rod of 1.75mm.
Step 3: filled layer injects
In the hole that the hydroxyapatite mixture for configuring thick shape uses needle tubing to be rapidly injected on artifical bone.Thick shape hydroxyl The proportion of apatite composite are as follows: hydroxyapatite content is 60 parts, sulfate hemihydrate calcium content is 30 parts, stearic acid content 4 Part, 50 parts of the bone cell growth factor and physiological saline content are 95 parts.
Step 4: coating spraying
Using plasma spraying method spraying hydroxyapatite coating, wherein 50 microns of coating layer thickness.
Step 5: post-processing
Step 4 products therefrom is heat-treated, heat treatment process are as follows: 240 DEG C of temperature, time 1.5h, heat treatment are completed Afterwards, it carries out disinfection and properly saves.
From above-mentioned technical proposal, it can be concluded that, a kind of artifical bone provided in an embodiment of the present invention and preparation method thereof has Following advantages:
1, in technical solution provided by the invention, artifical bone's main body is precisely manufactured by the way of 3D printing.3D printing system Standby artifical bone has two o'clock advantage: first is that 3D printing can preparation structure complexity artifical bone, can prepare traditional handicraft can not process Artificial bone structure;Second is that artifical bone's surface roughness of 3D printing is easily worked and adjusts with micro-structure, can effectively improve with The bond strength of living organism is conducive to osteocyte to artificial Bone Ingrowth.
2, compared with existing polyether-ether-ketone artifical bone on the market, bioactivity is effectively improved.Be blended that legal system obtains it is poly- Ether ether ketone artifical bone compares, due to blending method be row preparation is uniformly mixed by polyether-ether-ketone and hydroxyapatite, but It is the compactness because of polyether-ether-ketone structure, causes polyether-ether-ketone internal hydroxyl groups apatite particle to be wrapped, be unable to fully send out The bioactivity of hydroxyapatite is waved, area of new bone can not be grown to inside artifical bone.With the artificial bone product phase of coating preparation Than coating is to coat one layer of hydroxyapatite on the surface of polyether-ether-ketone artifical bone, and area of new bone cannot equally grow into artificial Inside bone, the loosening of artifical bone may cause.
3, some gaps or hole are set on model in advance when the data to artifical bone model, convenient for the later period The injection of hydroxyapatite.This novel processing method using 3D printing, it can be achieved that artificial bone structure optimized design.
4, not only intensity is high by artifical bone provided by the invention, but also has bioactivity, can promote the growth of new bone, can To improve combination between artifical bone and autologous bone and compatible, fatigue and abrasion are prevented.
In conclusion the present invention provides a kind of artifical bone, the structure of the artifical bone are as follows: artifical bone's main body and filling Layer, the surface of artifical bone's main body are provided with several cavernous structures, and the filled layer is filled in the cavernous structure;It is described Artifical bone's main body is polyether-ether-ketone artifical bone main body, and the filled layer is bone uptake activity articulamentum.The present invention also provides one The preparation method of the above-mentioned artifical bone of kind, are as follows: data acquisition and modeling, the injection of artifical bone's subject preparation, filled layer, post-processing;Its In, in step 3, the filled layer is bone uptake activity articulamentum.In technical solution provided by the invention, artificial bone implant is suffered from After in person's body, under the action of body fluid, bone uptake activity articulamentum can induce the generation of new bone;Further, generation is new Bone can grow into the inside of artifical bone's main body, form three-dimensional interpenetrating structure, be conducive to the combination of artifical bone and patient itself bone Structure avoids artifical bone from loosening, and activity is more flexible.A kind of artifical bone provided by the invention and preparation method thereof, solves existing In technology, after artifical bone is implanted into the patient, the technological deficiency that can not be merged very well with the bone of patient itself.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered It is considered as protection scope of the present invention.

Claims (10)

1. a kind of artifical bone, which is characterized in that the structure of the artifical bone are as follows: artifical bone's main body and filled layer, the artifical bone Main body includes: hollow shell, marrow channel and bracket, and the marrow channel is set to the inside of the hollow shell, described Marrow channel is connect by the bracket with the hollow shell;The filled layer is filled in the hollow shell and the marrow In gap between channel;
Artifical bone's main body is polyether-ether-ketone artifical bone main body, and the filled layer is bone uptake activity articulamentum.
2. artifical bone according to claim 1, which is characterized in that the volume of the filled layer accounts for artifical bone's main body body Long-pending 5~60%.
3. artifical bone according to claim 1, which is characterized in that the surface of the artifical bone is provided with protective coating, institute State the surface that protective coating is covered in artifical bone's main body;
The protective coating is hydroxyapatite coating layer.
4. artifical bone according to claim 1, which is characterized in that the activity articulamentum are as follows: hydroxyapatite layer or hydroxyl Base apatite composite layer;
The hydroxyapatite composite layer includes: in hydroxyapatite and the broken bone of human body, bone meal and the bone cell activity factor Any one or more.
5. artifical bone according to claim 4, which is characterized in that the partial size of hydroxyapatite is less than 100nm.
6. a kind of preparation method including artifical bone described in claim 1 to 5 any one, which is characterized in that the preparation side Method are as follows:
Step 1: data acquisition and modeling: acquisition both injured bones data prepare 3D bone model, the 3D bone mould according to the data Type is a hollow structure containing marrow channel, and hollow shell is connect with marrow channel by bracket;
Step 2: artifical bone's subject preparation: 3D bone model made from step 1 being prepared artifical bone master by the way of 3D printing Body;
Step 3: filled layer injects: will be between the hollow shell and marrow channel of artifical bone main body made from step 2 Interlayer infuses filled layer slurries, and intermediate product is obtained after solidification;
Step 4: post-processing: intermediate product obtained by step 3 is successively thermally treated with after disinfection, obtains artificial bone product;
Wherein, in step 3, the filled layer is bone uptake activity articulamentum.
7. preparation method according to claim 6, which is characterized in that the preparation method further include: coating spraying, it is described Coating spraying step carries out between step 3 and step 4;
The method of the coating spraying are as follows: in the surface spraying hydroxyapatite coating of the intermediate product, obtain spraying product, institute State the processing that spraying product continues step 4.
8. preparation method according to claim 6, which is characterized in that in step 3, filled layer slurries the preparation method comprises the following steps: In terms of mass parts, 50~90 parts of hydroxyapatite, 10~50 parts of half-H 2 O calcium sulphate, 1~5 part of stearic acid and physiological saline 50~ 100 parts of mixing, obtain filled layer slurries.
9. preparation method according to claim 8, which is characterized in that in step 3, filled layer slurries the preparation method comprises the following steps: In terms of mass parts, 50~90 parts of hydroxyapatite, 10~50 parts of half-H 2 O calcium sulphate, 1~5 part of stearic acid and physiological saline 50~ 100 parts of mixing, then it is 50~100 parts total with any one or more in the broken bone of human body, bone meal and the bone cell activity factor Mixing, obtains filled layer slurries.
10. preparation method according to claim 6, which is characterized in that in step 2, artifical bone's main body is hollow people Make bone main body, artifical bone's main body with a thickness of 2~10mm.
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