CN110368522B - Artificial bone and preparation method thereof - Google Patents

Artificial bone and preparation method thereof Download PDF

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Publication number
CN110368522B
CN110368522B CN201810332403.4A CN201810332403A CN110368522B CN 110368522 B CN110368522 B CN 110368522B CN 201810332403 A CN201810332403 A CN 201810332403A CN 110368522 B CN110368522 B CN 110368522B
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bone
artificial bone
artificial
hydroxyapatite
filling layer
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CN110368522A (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
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    • 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
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    • 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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  • Life Sciences & Earth Sciences (AREA)
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Abstract

The application belongs to the field of medical instruments, and particularly relates to an artificial bone and a preparation method thereof. The present invention provides an artificial bone, the artificial bone body comprising: the bone marrow channel is arranged inside the hollow shell and is connected with the hollow shell through the support; the filling layer is filled in a gap between the hollow shell and the bone marrow channel. The invention also provides a preparation method of the artificial bone. According to the technical scheme provided by the invention, after the artificial bone is implanted into a patient body, the bone growth active connecting layer can induce the generation of new bone under the action of body fluid; furthermore, the generated new bone can grow into the artificial bone main body to form a three-dimensional interpenetrating structure, so that the artificial bone can be combined with the bone of a patient, the artificial bone is prevented from loosening, and the movement is more flexible; solves the technical defect that the artificial bone can not be well fused with the bone of the patient after being implanted into the body of the patient in the prior art.

Description

Artificial bone and preparation method thereof
Technical Field
The application belongs to the field of medical instruments, and particularly relates to an artificial bone and a preparation method thereof.
Background
At present, more and more patients with bone defects are caused by factors such as trauma, infection, tumor and the like, and when the gap between the bone defects is too large to realize self healing, bone repair treatment is needed; the new artificial bone is implanted into the defect part to fill the gap caused by the bone defect.
In the prior art, after the artificial bone is implanted into a patient, relative motion can occur between bone joints along with daily activities of the patient, and further, adjacent bones can rub against the implanted artificial bone. Meanwhile, the implanted artificial bone cannot be fused with the bone of a patient by the rejection of foreign matters of the body, so that the corresponding joint implanted into the bone is inconvenient to move and sometimes even generates severe pain.
Therefore, the development of an artificial bone and a preparation method thereof for solving the technical defect that the artificial bone cannot be well fused with the bone of a patient after being implanted into the patient in the prior art becomes a problem to be solved by those skilled in the art.
Disclosure of Invention
In view of the above, the invention provides an artificial bone and a preparation method thereof, which are used for solving the technical defect that the artificial bone cannot be well fused with the bone of a patient after being implanted into the body of the patient in the prior art.
The invention provides an artificial bone, which has the following structure: artificial bone body and filling layer, artificial bone body includes: the bone marrow channel is arranged inside the hollow shell and is connected with the hollow shell through the support; the filling layer is filled in a gap between the hollow shell and the bone marrow channel;
the artificial bone main body is a polyether-ether-ketone artificial bone main body, and the filling layer is a bone growth active connecting layer.
Preferably, the volume of the filling layer accounts for 5-60% of the volume of the artificial bone body.
Preferably, the surface of the artificial bone is provided with a protective coating, and the protective coating covers the surface of the artificial bone body;
the protective coating is a hydroxyapatite coating.
Preferably, the active tie layer is: a hydroxyapatite layer or a hydroxyapatite composite layer;
the hydroxyapatite composite layer comprises: hydroxyapatite and one or more of crushed bone, bone powder and bone cell active factor.
Preferably, the particle size of the hydroxyapatite is less than 100 nm.
The invention also provides a preparation method of the artificial bone, which comprises the following steps:
step one, data acquisition and modeling: acquiring damaged bone data, and preparing a 3D bone model according to the data, wherein the 3D bone model is a hollow structure with a bone marrow channel, and a hollow shell is connected with the bone marrow channel through a bracket;
step two, preparing the artificial bone main body: preparing an artificial bone main body from the 3D bone model prepared in the step one by adopting a 3D printing mode;
step three, filling layer injection: filling layer slurry into the interlayer between the hollow shell of the artificial bone main body prepared in the step two and the bone marrow channel, and curing to obtain an intermediate product;
step four, post-treatment: the intermediate product obtained in the third step is sequentially subjected to heat treatment and sterilization to obtain an artificial bone product;
in the third step, the filling layer is a bone growth active connecting layer.
Preferably, the preparation method further comprises: coating spraying, wherein the coating spraying step is carried out between the third step and the fourth step;
the coating spraying method comprises the following steps: and spraying a hydroxyapatite coating on the surface of the intermediate product to obtain a sprayed product, and continuing to perform the treatment of the fourth step on the sprayed product.
Preferably, in step three, the preparation method of the slurry for the filling layer comprises the following steps: 50-90 parts by mass of hydroxyapatite, 10-50 parts by mass of calcium sulfate hemihydrate, 1-5 parts by mass of stearic acid and 50-100 parts by mass of normal saline are mixed to obtain the slurry of the filling layer.
Preferably, in step three, the preparation method of the slurry for the filling layer comprises the following steps: the filling layer slurry is prepared by mixing 50-90 parts by mass of hydroxyapatite, 10-50 parts by mass of calcium sulfate hemihydrate, 1-5 parts by mass of stearic acid and 50-100 parts by mass of normal saline, and then mixing the mixture with 50-100 parts by mass of any one or more of broken bones of a human body, bone powder and bone cell active factors.
Preferably, in the second step, the artificial bone main body is a hollow artificial bone main body, and the thickness of the artificial bone main body is 2-10 mm.
In summary, the present invention provides an artificial bone, which has a structure: artificial bone body and filling layer, artificial bone body includes: the bone marrow channel is arranged inside the hollow shell and is connected with the hollow shell through the support; the filling layer is filled in a gap between the hollow shell and the bone marrow channel; the artificial bone main body is a polyether-ether-ketone artificial bone main body, and the filling layer is a bone growth active connecting layer. The invention also provides a preparation method of the artificial bone, which comprises the following steps: data acquisition and modeling, artificial bone main body preparation, filling layer injection and post-processing; in the third step, the filling layer is a bone growth active connecting layer. According to the technical scheme provided by the invention, after the artificial bone is implanted into a patient body, the bone growth active connecting layer can induce the generation of new bone under the action of body fluid; furthermore, the generated new bone can grow into the artificial bone main body to form a three-dimensional interpenetrating structure, so that the artificial bone can be combined with the bone of a patient, the artificial bone is prevented from loosening, and the activity is more flexible. The artificial bone and the preparation method thereof provided by the invention solve the technical defect that the artificial bone cannot be well fused with the bone of a patient after being implanted into the body of the patient in the prior art.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 is a schematic flow chart of a method for preparing an artificial bone according to the present invention;
FIG. 2 is a schematic structural view of an artificial bone according to the present invention;
the artificial bone comprises an artificial bone main body 1, a bracket 11, a bone marrow channel 12 and a filling layer 2.
Detailed Description
The embodiment of the invention provides an artificial bone and a preparation method thereof, which are used for solving the technical defect that the artificial bone cannot be well fused with the bone of a patient after being implanted into the body of the patient in the prior art.
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In order to explain the present invention in more detail, an artificial bone and a method for preparing the same according to the present invention will be described in detail with reference to the following examples.
Referring to fig. 2, an embodiment of the present invention provides an artificial bone, which has a structure: artificial bone main part and filling layer, artificial bone main part includes: the bone marrow channel is arranged in the hollow shell and is connected with the hollow shell through the support; the filling layer is filled in a gap between the hollow shell and the bone marrow channel; the artificial bone main body is a polyether-ether-ketone artificial bone main body, and the filling layer is a bone growth active connecting layer. The artificial bone and the preparation method thereof provided by the embodiment of the invention solve the technical defect that the artificial bone cannot be well fused with the bone of a patient after being implanted into the body of the patient in the prior art.
According to the technical scheme provided by the embodiment of the invention, the filling layer is the bone growth active connecting layer, after the artificial bone is implanted into the bone defect part of a patient, the filling layer can be partially degraded under the action of body fluid due to good bioactivity and biocompatibility of the bone growth active connecting layer, and the free substances after degradation can be absorbed and utilized by human tissues to grow new tissues, so that a good bone conduction effect is generated. The new bone generated by bone conduction can grow into the artificial bone main body to form a three-dimensional interpenetrating structure with the original bone and the new bone, so that the artificial bone can be combined with the bone of the patient, and the technical defect that the artificial bone cannot be fused with the bone of the patient when implanted into the patient is overcome; further, the artificial bone is prevented from loosening, the patient can move more freely, and pain and discomfort caused by friction between the artificial bone and the self bone are avoided.
Second, in the practical application, in order to effectively ensure sufficient rigidity and strength of the artificial bone, it is also necessary to have sufficient surface smoothness, and to have good biocompatibility without generating rejection reaction after implantation. In the present application, the artificial bone body is a polyetheretherketone artificial bone body. The PEEK artificial bone main body can meet all the requirements, and the elastic modulus of the PEEK artificial bone main body is close to that of a human bone.
Therefore, the structural supporting function of the polyether-ether-ketone is matched with the function of stimulating the generation of new bones by the bone growth active connecting layer, after the artificial bones are implanted into the bodies of patients, the artificial bones not only have enough strength and rigidity, but also stimulate the generation of new bones and promote the fusion of the new bones and the original bones in the bodies. After the artificial bone is implanted, the foreign body sensation is not obvious, the movement is flexible, and the pain sensation can not be generated.
Thirdly, according to the actual application requirements, the hole-shaped structure can be selected to penetrate through the artificial bone body or only perforate the surface, or the combination of the penetration and the surface perforation; moreover, if holes are drilled on the surface of the artificial bone body, the adjacent hole-shaped structures can also be designed to be communicated with each other at the bottom. The design of the porous structure needs to be individually designed according to the characteristics of the implantation site, and on the basis of the present application, the design of the porous structure can be obtained without creative work by those skilled in the art, and will not be described herein.
Further optimization of the technical solution is required to ensure that the artificial bone has sufficient strength and rigidity, and if the ratio of the porous structures filled with the bone growth active connecting layer is too large or the single porous structure is too large, the artificial bone may have insufficient strength and rigidity or insufficient local strength; meanwhile, it is also necessary to ensure that the implanted artificial bone can be fused well with the original bone in the body, and if the ratio of the porous structure filled with the bone growth active connecting layer is too small or the local pore diameter is too small, the artificial bone may not be fused well with the original bone in the body of the patient or partially. Therefore, the embodiment of the invention provides an artificial bone. The volume of the porous structure accounts for 5-60% of the volume of the artificial bone main body, and the diameter of the porous structure is 0.5-10 mm.
In order to further improve the bioactivity of the surface of the artificial bone and facilitate the fusion of the artificial bone and the surrounding skeleton, the technical scheme provided by the embodiment of the invention is that the surface of the artificial bone is provided with a protective coating which covers the surface of the artificial bone main body; the protective coating is a hydroxyapatite coating.
According to the actual use requirement, when in application, the thickness of the protective coating is designed to be 10-100 μm, so that the bioactivity of the surface of the artificial bone can be effectively improved, and the design requirements of stable property and low cost of the active connecting layer can be considered on the basis of ensuring the good bioactivity of the active connecting layer, wherein in the technical scheme provided by the embodiment of the invention, the active connecting layer is as follows: a hydroxyapatite layer or a hydroxyapatite composite layer; the hydroxyapatite composite layer comprises: hydroxyapatite and one or more of crushed bone, bone powder and bone cell active factor.
According to the research on human bones, hydroxyapatite in the human bones is mainly of a nano-scale needle-like single crystal structure, so that in order to realize better biological performance of an active connecting layer, the particle size of the hydroxyapatite is less than 100nm in the technical scheme provided by the embodiment of the invention. .
Referring to fig. 1, an embodiment of the present invention further provides a method for preparing an artificial bone, including:
step one, data acquisition and modeling: the method comprises the steps of collecting damaged bone data, preparing a 3D bone model according to the data, and arranging a plurality of hole-shaped structures on the surface of the 3D bone model.
According to CT scanning data or MRI scanning data of a bone part to be implanted, introducing MIMICS software for processing, outputting an STL format file, introducing the file into 3-MATIC software for 3D modeling, establishing a 3D model of the artificial bone, and outputting the STL format file. According to different loading forces applied to different parts of bones of a human body, a plurality of support structures are arranged between the hollow shell of the 3D bone model and the bone marrow channel.
Step two, preparing the artificial bone main body: and D, preparing an artificial bone main body by adopting a 3D printing mode and arranging a plurality of support structures between the surface prepared in the step one and the bone marrow channel.
The artificial bone needs to be matched with surrounding bones, so the structure complexity is high, and meanwhile, a bone marrow channel needs to be preset in the center of the artificial bone, so the structure complexity of the artificial bone is further improved. In order to ensure that the complex and fine artificial bone can be prepared and reduce the waste of raw materials in the preparation process of the artificial bone main body, the preparation of the artificial bone main body is carried out by adopting a 3D printing mode in the technical scheme provided by the invention.
Step three, filling layer injection: filling a filling layer slurry between the surface of the artificial bone main body prepared in the step two and the bone marrow channel, and curing to obtain an intermediate product; wherein, the filling layer is a bone growth active connecting layer.
The preparation method of the filling layer slurry comprises the following steps: 50-90 parts by mass of hydroxyapatite, 10-50 parts by mass of calcium sulfate hemihydrate, 1-5 parts by mass of stearic acid and 50-100 parts by mass of normal saline are mixed to obtain the slurry of the filling layer.
In the practical application process, in order to further improve the bioactivity of the filling layer, a substance for promoting the growth of bone cells can be added into the slurry of the filling layer, so that the optimal preparation method of the slurry of the filling layer comprises the steps of mixing 50-90 parts by mass of hydroxyapatite, 10-50 parts by mass of calcium sulfate hemihydrate, 1-5 parts by mass of stearic acid and 50-100 parts by mass of normal saline, and then mixing the mixture with 50-100 parts by mass of any one or more of broken bones of a human body, bone powder and bone cell active factors to obtain the slurry of the filling layer.
When the filling layer is injected, because the particle size of the filling layer is very small, the filling layer can be injected into the porous structure on the surface of the artificial bone body by a needle tube or other suitable methods, and the injection method of the filling layer belongs to common knowledge known to those skilled in the art and is not described herein again.
Step four, post-treatment: and (4) sequentially carrying out heat treatment and disinfection on the intermediate product obtained in the step three to obtain an artificial bone product.
Through the heat treatment step, the internal stress of the artificial bone product can be eliminated or reduced, and the mechanical property and the biological property of the artificial bone product can be improved. Specifically, the heat treatment process can be carried out at the temperature of 200-250 ℃ for 1-4 h; the fine adjustment can be performed according to the actual characteristics of the artificial bone structure, and is not described herein again.
Further, the preparation method of the artificial bone provided by the embodiment of the invention further comprises the following steps: coating spraying, wherein the coating spraying step is carried out between the third step and the fourth step; the coating spraying method comprises the following steps: and spraying a hydroxyapatite coating on the surface of the intermediate product to obtain a sprayed product, and continuing to perform the treatment of the fourth step on the sprayed product.
In order to effectively reduce the weight of the artificial bone, reduce the foreign body sensation after the implantation of a patient and reduce the using amount of the artificial bone main body, in the second step, the prepared artificial bone main body is a hollow artificial bone main body, and the thickness of the surface layer of the artificial bone main body is 2-10 mm. Referring to fig. 2, a bone marrow channel is formed in a central portion of the artificial bone, and the stability of the morphological structure is maintained between the bone marrow channel and the hollow artificial bone through a scaffold.
Furthermore, the cross-sectional shape of the scaffold between the surface of the artificial bone and the bone marrow channel can be selected from regular cross-sectional shapes such as a cylinder, a square, a triangle and the like, and also can be selected from irregular cross-sectional shapes, cross structures, space grids and the like, and the design of the cross-sectional shape can be changed according to the specific shape of the artificial bone.
The present invention will be further described with reference to the following examples.
Example 1
This example is a specific example of preparing the artificial bone product 1.
An artificial bone preparation method comprises the following steps:
step one, data acquisition and modeling
Scanning a bone defect part of a patient by adopting high-precision CT to obtain three-dimensional model data; and importing the data into MIMICS software for processing, and outputting the STL format file. And importing the file into 3-MATIC software to perform 3D modeling, establishing a three-dimensional model of the artificial bone, and outputting the STL format file.
A plurality of support structures are arranged between the surface of the artificial bone body obtained through 3D modeling and the bone marrow channel, the volume of each support structure accounts for 20% of the volume of the artificial bone body, and the diameter of each support structure is 5 mm.
Step two, preparing the artificial bone main body
And importing the obtained STL format file into an FDM 3D printer for 3D printing, wherein the 3D printing consumable material is a medical PEEK wire with the diameter of 1.75 mm.
Step three, filling layer injection
The prepared dense hydroxyapatite mixture is quickly injected into the hole on the artificial bone by a needle tube. The mixture ratio of the thickened hydroxyapatite mixture is as follows: the content of hydroxyapatite is 90 parts, the content of calcium sulfate hemihydrate is 10 parts, the content of stearic acid is 1 part and the content of normal saline is 100 parts.
Step four, spraying the coating
The hydroxyapatite coating was sprayed by plasma spraying, wherein the coating thickness was 20 microns.
Step five, post-treatment
And D, carrying out heat treatment on the product obtained in the step four, wherein the heat treatment process comprises the following steps: the temperature is 200 ℃, the time is 4 hours, and after the heat treatment is finished, the sterilization is carried out and the storage is proper.
Example 2
This example is a specific example of preparing the artificial bone product 1.
An artificial bone preparation method comprises the following steps:
step one, data acquisition and modeling
Scanning a bone defect part of a patient by adopting high-precision CT to obtain three-dimensional model data; and importing the data into MIMICS software for processing, and outputting the STL format file. And importing the file into 3-MATIC software to perform 3D modeling, establishing a three-dimensional model of the artificial bone, and outputting the STL format file.
A plurality of support structures are arranged between the surface of the artificial bone body obtained through 3D modeling and the bone marrow channel, the volume of each support structure accounts for 30% of the volume of the artificial bone body, and the diameter of each support structure is 6 mm.
Step two, preparing the artificial bone main body
And importing the obtained STL format file into an FDM 3D printer for 3D printing, wherein the 3D printing consumable material is a medical PEEK wire with the diameter of 1.75 mm.
Step three, filling layer injection
The prepared dense hydroxyapatite mixture is quickly injected into the hole on the artificial bone by a needle tube. The mixture ratio of the thick hydroxyapatite mixture is as follows by mass: 80 parts of hydroxyapatite, 15 parts of calcium sulfate hemihydrate, 2 parts of stearic acid, 50 parts of a mixture of human broken bones and bone meal and 90 parts of normal saline.
Step four, spraying the coating
The hydroxyapatite coating was sprayed by plasma spraying, wherein the coating thickness was 30 microns.
Step five, post-treatment
And D, carrying out heat treatment on the product obtained in the step four, wherein the heat treatment process comprises the following steps: the temperature is 220 ℃, the time is 3 hours, and after the heat treatment is finished, the sterilization is carried out and the storage is proper.
Example 3
This example is a specific example of preparing the artificial bone product 1.
An artificial bone preparation method comprises the following steps:
step one, data acquisition and modeling
Scanning a bone defect part of a patient by adopting high-precision CT to obtain three-dimensional model data; and importing the data into MIMICS software for processing, and outputting the STL format file. And importing the file into 3-MATIC software to perform 3D modeling, establishing a three-dimensional model of the artificial bone, and outputting the STL format file.
A plurality of support structures are arranged between the surface of the artificial bone body obtained through 3D modeling and the bone marrow channel, the volume of each support structure accounts for 40% of the volume of the artificial bone body, and the aperture of each porous structure is 7 mm.
Step two, preparing the artificial bone main body
And importing the obtained STL format file into an FDM 3D printer for 3D printing, wherein the 3D printing consumable material is a medical PEEK wire with the diameter of 1.75 mm.
Step three, filling layer injection
The prepared dense hydroxyapatite mixture is quickly injected into the hole on the artificial bone by a needle tube. The mixture ratio of the thickened hydroxyapatite mixture is as follows: 70 parts of hydroxyapatite, 20 parts of calcium sulfate hemihydrate, 3 parts of stearic acid and 90 parts of normal saline.
Step four, spraying the coating
The hydroxyapatite coating was sprayed by plasma spraying, wherein the coating thickness was 40 microns.
Step five, post-treatment
And D, carrying out heat treatment on the product obtained in the step four, wherein the heat treatment process comprises the following steps: the temperature is 230 ℃ and the time is 2 hours, and after the heat treatment is finished, the sterilization is carried out and the storage is proper.
Example 4
This example is a specific example of preparing the artificial bone product 1.
An artificial bone preparation method comprises the following steps:
step one, data acquisition and modeling
Scanning a bone defect part of a patient by adopting high-precision CT to obtain three-dimensional model data; and importing the data into MIMICS software for processing, and outputting the STL format file. And importing the file into 3-MATIC software to perform 3D modeling, establishing a three-dimensional model of the artificial bone, and outputting the STL format file.
A plurality of support structures are arranged between the surface of the artificial bone body obtained through 3D modeling and the bone marrow channel, the volume of each support structure accounts for 50% of the volume of the artificial bone body, and the aperture of each porous structure is 8 mm.
Step two, preparing the artificial bone main body
And importing the obtained STL format file into an FDM 3D printer for 3D printing, wherein the 3D printing consumable material is a medical PEEK wire with the diameter of 1.75 mm.
Step three, filling layer injection
The prepared dense hydroxyapatite mixture is quickly injected into the hole on the artificial bone by a needle tube. The mixture ratio of the thickened hydroxyapatite mixture is as follows: 60 parts of hydroxyapatite, 30 parts of calcium sulfate hemihydrate, 4 parts of stearic acid, 50 parts of bone cell growth factor and 95 parts of normal saline.
Step four, spraying the coating
The hydroxyapatite coating was sprayed by plasma spraying, wherein the coating thickness was 50 microns.
Step five, post-treatment
And D, carrying out heat treatment on the product obtained in the step four, wherein the heat treatment process comprises the following steps: the temperature is 240 ℃ and the time is 1.5h, and after the heat treatment is finished, the sterilization is carried out and the storage is proper.
According to the technical scheme, the artificial bone and the preparation method thereof provided by the embodiment of the invention have the following advantages:
1. according to the technical scheme provided by the invention, the artificial bone main body is accurately manufactured in a 3D printing mode. The 3D printing method for preparing the artificial bone has two advantages: firstly, 3D printing can prepare artificial bones with complex structures, and can prepare artificial bone structures which can not be processed by the traditional process; secondly, the surface roughness and the microstructure of the artificial bone printed by the 3D printer are easy to process and adjust, the bonding strength with a biological organism can be effectively improved, and the growth of bone cells into the artificial bone is facilitated.
2. Compared with the prior polyether-ether-ketone artificial bone on the market, the biological activity is effectively improved. Compared with the polyether-ether-ketone artificial bone prepared by the co-mixing method, the blending method is prepared by uniformly mixing polyether-ether-ketone and hydroxyapatite, but hydroxyapatite particles in polyether-ether-ketone are wrapped due to the compactness of a polyether-ether-ketone structure, so that the bioactivity of the hydroxyapatite cannot be fully exerted, and new bone cannot grow into the artificial bone. Compared with the artificial bone product prepared by the coating method, the coating method only coats a layer of hydroxyapatite on the surface of the polyether-ether-ketone artificial bone, and the new bone can not grow into the artificial bone, possibly causing the artificial bone to loosen.
3. When the data of the artificial bone are modeled, a plurality of gaps or holes are arranged on the model in advance, so that the hydroxyapatite can be conveniently injected in the later period. By adopting the novel processing mode of 3D printing, the optimal design of the artificial bone structure can be realized.
4. The artificial bone provided by the invention has high strength and bioactivity, can promote the growth of new bones, can improve the combination and compatibility between the artificial bone and autologous bones, and can prevent fatigue and abrasion.
In summary, the present invention provides an artificial bone, which has a structure: the artificial bone comprises an artificial bone main body and a filling layer, wherein a plurality of hole-shaped structures are arranged on the surface of the artificial bone main body, and the filling layer is filled in the hole-shaped structures; the artificial bone main body is a polyether-ether-ketone artificial bone main body, and the filling layer is a bone growth active connecting layer. The invention also provides a preparation method of the artificial bone, which comprises the following steps: data acquisition and modeling, artificial bone main body preparation, filling layer injection and post-processing; in the third step, the filling layer is a bone growth active connecting layer. According to the technical scheme provided by the invention, after the artificial bone is implanted into a patient body, the bone growth active connecting layer can induce the generation of new bone under the action of body fluid; furthermore, the generated new bone can grow into the artificial bone main body to form a three-dimensional interpenetrating structure, which is beneficial to the combination structure of the artificial bone and the bone of the patient, thereby avoiding the artificial bone from loosening and having more flexible activity. The artificial bone and the preparation method thereof provided by the invention solve the technical defect that the artificial bone cannot be well fused with the bone of a patient after being implanted into the body of the patient in the prior art.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims (6)

1. An artificial bone, characterized in that the structure of the artificial bone is: artificial bone body and filling layer, artificial bone body includes: the bone marrow channel is arranged inside the hollow shell and is connected with the hollow shell through the support; the filling layer is filled in a gap between the hollow shell and the bone marrow channel;
the artificial bone main body is a polyether-ether-ketone artificial bone main body, the filling layer is a bone growth active connecting layer, and the active connecting layer is as follows: a hydroxyapatite composite layer;
the hydroxyapatite composite layer comprises: hydroxyapatite and any one or more of broken bones of human bodies, bone meal and bone cell active factors;
the surface of the hollow shell is provided with a porous structure;
the hole-shaped structure penetrates through the hollow shell and the bone marrow channel;
the surface of the artificial bone is provided with a protective coating which covers the surface of the artificial bone main body;
the protective coating is a hydroxyapatite coating.
2. An artificial bone according to claim 1, wherein the volume of the filling layer is 5-60% of the volume of the artificial bone body.
3. The artificial bone according to claim 1, wherein the particle size of the hydroxyapatite in the hydroxyapatite composite layer is less than 100 nm.
4. A method of preparing an artificial bone comprising any one of claims 1 to 3, wherein the method comprises:
step one, data acquisition and modeling: acquiring damaged bone data, and preparing a 3D bone model according to the data, wherein the 3D bone model is a hollow structure with a bone marrow channel, and a hollow shell is connected with the bone marrow channel through a bracket;
step two, preparing the artificial bone main body: preparing an artificial bone main body from the 3D bone model prepared in the step one by adopting a 3D printing mode;
step three, filling layer injection: filling layer slurry into the interlayer between the hollow shell of the artificial bone main body prepared in the step two and the bone marrow channel, and curing to obtain an intermediate product;
step four, post-treatment: the intermediate product obtained in the third step is sequentially subjected to heat treatment and sterilization to obtain an artificial bone product;
in the third step, the filling layer is a bone growth active connecting layer;
the active connection layer is: a hydroxyapatite composite layer;
the hydroxyapatite composite layer comprises: hydroxyapatite and any one or more of broken bones of human bodies, bone meal and bone cell active factors;
the preparation method further comprises the following steps: coating spraying, wherein the coating spraying step is carried out between the third step and the fourth step;
the coating spraying method comprises the following steps: and spraying a hydroxyapatite coating on the surface of the intermediate product to obtain a sprayed product, and continuing to perform the treatment of the fourth step on the sprayed product.
5. The method according to claim 4, wherein the slurry for the filler layer is prepared in the third step by: the filling layer slurry is prepared by mixing 50-90 parts by mass of hydroxyapatite, 10-50 parts by mass of calcium sulfate hemihydrate, 1-5 parts by mass of stearic acid and 50-100 parts by mass of normal saline, and then mixing the mixture with 50-100 parts by mass of any one or more of broken bones of a human body, bone powder and bone cell active factors.
6. The method according to claim 4, wherein in the second step, the artificial bone body is a hollow artificial bone body, and the thickness of the artificial bone body is 2 to 10 mm.
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Publication number Priority date Publication date Assignee Title
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CN107049561A (en) * 2017-01-23 2017-08-18 北京东玥润骐医疗技术发展有限公司 Bone grafting zygapophysial joint fusion device can be strutted

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CN101147704A (en) * 2006-09-18 2008-03-26 中国人民解放军军事医学科学院野战输血研究所 Implantable artificial substituting unit
WO2009120886A3 (en) * 2008-03-28 2010-01-07 Drexel University Design and manufacturing of bioactive implanted surgical fixation devices using injection molding of gradient cellular strucures
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