CN105013006A - Bioabsorbable bone repair material and its use and manufacturing method - Google Patents

Bioabsorbable bone repair material and its use and manufacturing method Download PDF

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Publication number
CN105013006A
CN105013006A CN201510357178.6A CN201510357178A CN105013006A CN 105013006 A CN105013006 A CN 105013006A CN 201510357178 A CN201510357178 A CN 201510357178A CN 105013006 A CN105013006 A CN 105013006A
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bone
preparation
calcium phosphate
biological absorbable
renovating material
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吴天根
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DONGGUAN TIANTIANXIANGSHANG MEDICAL TECHNOLOGY CO Ltd
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DONGGUAN TIANTIANXIANGSHANG MEDICAL TECHNOLOGY CO Ltd
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Priority to CN201510357178.6A priority Critical patent/CN105013006A/en
Priority to PCT/CN2015/087598 priority patent/WO2016206180A1/en
Publication of CN105013006A publication Critical patent/CN105013006A/en
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    • 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
    • A61L27/50Materials 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
    • A61L27/58Materials at least partially resorbable by the body
    • 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
    • B33Y80/00Products made by additive manufacturing

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

Abstract

The invention relates to a bioabsorbable bone repair material and its use and manufacturing method. The bioabsorbable bone repair material is prepared from a bioabsorbable polyester polymer and calcium phosphate. Through injection molding and material increasing manufacture (3D printing), the bioabsorbable bone repair material can be processed to form desired prosthesis bone, the surface of the prosthesis bone is coated with a bone induction promoting substance and the coated prosthesis bone is implanted into a limb. The prosthesis bone prepared from the bioabsorbable bone repair material can be used for fast and individular repair of bone injuries caused by various reasons, has good biocompatibility and has enough mechanical strength and bone induction functions.

Description

A kind of biological absorbable bone renovating material and application thereof and manufacture method
Technical field
The invention belongs to artificial prosthesis technical field, be specifically related to biological absorbable bone renovating material and application and manufacture method in Bone Defect Repari.
Background technology
Cranial defect on bed caused by a variety of causes is very common.China's caused trauma fracture, spinal column degenerative disease and orthopaedic disease such as bone tumor, bone tuberculosis in vehicle accident and work safety accident every year, causes Cranial defect or dysfunction more than 3,000,000 people according to estimates.Carry out repairing being shaped to Cranial defect clinically and become the common recognition of Orthopeadic Surgery doctor.
Requiring to include clinically to desirable bone renovating material: the bio-compatibility that (1) is good: except the General Requirements (as nontoxic, not teratogenesis etc.) meeting medical material, also to be beneficial to seed cell to stick, breed, catabolite is to cytotoxic side effect, do not cause inflammation reaction, is even beneficial to Growth of Cells and differentiation; (2) good biological degradability: host material should be able to be degraded after completing support effect, degradation rate should adapt with tissue cell growth rate, and degradation time should be able to make artificial adjustment according to tissue growth characteristic; (3) have 3 D stereo loose structure: host material can be processed into 3-D solid structure, be beneficial to cell adhesion and extrtacellular matrix deposition, nutrition and oxygen enter people, and metabolite discharge, is also conducive to blood vessel and nerve is grown into; (4) plasticity and certain mechanical strength: host material has good plasticity, can be made into definite shape in advance.And there is certain mechanical strength, for cambium provides support, and keep certain hour until cambium has own biological mechanical characteristic: (5) bone guided is active: first engineering material of bone tissue is played and considered its osteoinductive and bone conductibility; (6) easy sterilization property.
Traditional repairing bone material mainly contains lucite, methyl methacrylate bone cement, titanium plate, silicane rubber plate, macromolecular fibre reinforcing material and two vinegar phenol esters of acrylic acid micropore plasticity artificial bones etc.There is tissue compatibility difference, not withstand voltage in these materials, not thermal insulation/cold-proof and be difficult to the shortcomings such as moulding, processing mostly.
So far, apply more artificial material mainly titanium alloy, because titanium alloy material is nontoxic, cause inflammation and sensitization is low, have good bio-compatibility and lower biology transformation, corrosion resistance high, obtains clinical practice more and more widely.Because titanium netting gear has stronger compressive property, tissue compatibility is good, and after implant into body, fibroblast can be grown into the micropore of titanium net, and titanium net and tissue being combined together, and has calcification and ossified trend, is more satisfactory manual repair material.Although titanium alloy reticulated is better in profile aesthetic, expensive, be difficult to processing and non-degradable, patient need carry all the life.So far, also do not have a kind of material can be completely eligible, Comparatively speaking, Preserve selef-cranium be the optimal material of repairing cranial defects to have scholar to think.The Preserve selef-cranium applied the earliest, still in clinical practice in occupation of critical role.Preserve selef-cranium meets own physiological, there is not immunological rejection, seldom infects, hydrops, the common complication of artificial material such as to loosen.The Preserve selef-cranium that General low temperature is preserved can be survived after implanting, and be particularly useful for child, and artificial material can not increase with the increase of head.Preserve selef-cranium has economy, does not need moulding advantage, but its tissue compatibility, whether also have normal physiological characteristics, and whether Osteoblastic Cells Derived from Periosteum also survives after bone lobe is in vitro all indefinite, in addition, after also having bone lobe to transplant, the problem values such as absorption and hypertrophy obtains and studies further.
Polyphosphazene polymer lactic acid (polylactide, PLA) there is good hot formability, by its degradation speeds of scalable such as Molecular regulator amount and structures, to meet different clinical requirements, therefore the requirement that can substantially meet in bone tissue engineer field as cellular growth support material, but poly-lactic acid material mechanical strength is poor, and catabolite is slightly in acid, two large shortcomings are had: one by its implantation instrument/repair materials of making, acid product can be produced during poly-lactic acid material degradation in vivo, those products can make implantation perienchyma that non-infectious inflammation (bio-compatibility is poor) occurs, its two, existing poly-lactic acid material lacks enough mechanical strengths to meet human organ, especially the normal demand of bone object official.Calcium phosphate is the main inorganic composition of nature bone, 60wt% is accounted for greatly in sclerotin, its elementary cell is needle-like phosphorite crystal, can be formed at short notice combine closely after implant into body with the hard and soft tissue of human body, is the very outstanding bone renovating material of a kind of performance.But apatite single crystal body is frangible, intensity difference, poor toughness and not easily the shortcoming such as processing constrain it in clinical clinical practice.
Summary of the invention
In order to solve the problem, the object of the present invention is to provide a kind of biological absorbable bone renovating material, this material can meet the condition that repairing bone material should possess, and has good bio-compatibility simultaneously, enough mechanical strengths and self-bone grafting function.
Two of object of the present invention provides application of described biological absorbable bone renovating material and preparation method thereof.
Three of object of the present invention provides artificial prosthesis bone in.
The present invention is achieved through the following technical solutions:
A kind of biological absorbable bone renovating material, comprise the Bioabsorbable Polyesters polymer and calcium phosphate that calculate in mass ratio, the mass ratio of described biologically absorbable polymer and calcium phosphate is 1 ~ 99: 99 ~ 1.
Preferably, described Bioabsorbable Polyesters polymer is polyphosphazene polymer lactate material.
Preferably, described polyphosphazene polymer lactate material is poly (glycolide-lactide) (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), poly-D, one or more combination thing in Pfansteihl (PDLA), PGA (PGA), poly-D, L-Acetic acid, hydroxy-, bimol. cyclic ester.
Preferably, described calcium phosphate is the one or more combination thing in the amorphous calcium phosphate (ACP) of Nano grade, dicalcium phosphate (DCP), tricalcium phosphate (TCP), hydroxyapatite five calcium (HAP), tetracalcium phosphate carbon monoxide (TTCP).
The preparation method of described biological absorbable bone renovating material, extrudes obtained by the Bioabsorbable Polyesters polymer of described amount and calcium phosphate by high speed (being greater than 1000 revs/min) blender, double screw extruder at 100 ~ 400 DEG C; Or described amount Bioabsorbable Polyesters polymer and calcium phosphate are passed through chemical method (such as, change the positive and negative charge on calcium phosphate surface, or add binding agent in the composite, to increase its conjugation etc. in polylactic acid macromolecule, but be not limited to these methods) nanoparticle suspensions is obtained in macromolecular material.
A preparation method for artificial prosthesis bone, is obtained described biological absorbable bone renovating material by injection moulding or the facture preparation of increasing material.
Wherein, described injection moulding is specially:
When being made by injection moulding, first by surface sweeping image digitizations such as the CT/MRI of patient trauma bone, be converted into the discernible cad file of injection machine, on injection machine, at 100 ~ 400 DEG C, be then injection molded into the model of damaged bone; Obtain described artificial prosthesis, finally implanted by Orthopeadic Surgery doctor in the skeleton of damage.
Described increasing material autofrettage is specially:
A, the CT/MRI image data open source software of damaged bone is converted into stl file, or the discernible file of other 3D printers, set up the model of damaged bone;
B, described biological absorbable bone renovating material is processed into the spendable wire rod of 3D printer;
C, the wire rod will be processed in B by melt and dissolved sintering process, by the model set up in A, successively sinter to be superimposed as by 3D printer and obtain described artificial prosthesis bone.
When 3D prints, by polyphosphazene polymer lactic acid-calcium phosphate composite material wire rod, by printer, pressing set up bone model, successively melting superposition, finally intending the prosthese to forming former damaged bone.Increasing material makes the printer adopted and can be but be not limited to fusion sediment 3D printer.On market, existing many moneys 3D printer all can meet the demand of this printing.
The application of described artificial prosthesis bone, by bone growth inducing material on described artificial prosthesis bone outer surface, is implanted to the bone place of damage.The present invention is applicable to any bone injury, especially skull.
The application of described artificial prosthesis bone, described bone growth inducing material is the one or more combination thing in injured patients's autogenous bone marrow stem cell, the Osteogenic Stem of artificial In vitro culture, osteogenic factor and medicine.
Nano-calcium phosphate granule is added in polylactic acid macromolecular material by special technique by the present invention, forms polyphosphazene polymer lactic acid-nano-calcium phosphate composite.Calcium phosphate is one of main component of skeleton, be otherwise known as bioceramic, containing multiple various combination, include but not limited to hydroxyapatite (Ca.sub.10 (PO.sub.4) .sub.6 (OH) .sub.2), fluor-apatite (Ca.sub.10 (PO.sub.4) .sub.6F.sub.2), carbonization apatite (Ca.sub.10 (PO.sub.4) .sub.6CO.sub.3), tricalcium phosphate (Ca.sub.3 (PO.sub.4) .sub.2), OCP (Ca.sub.8H.sub.2 (PO.sub.4) 6-5H.sub.2O), calcium pyrophosphate (Ca.sub.2P.sub.2O.sub.7-2H.sub.2O), tetracalcium phosphate (Ca.sub.4P.sub.2O.sub.9) and dicalcium phosphate dihydrate (CaHPO.sub.4-2H.sub.2O).Calcium phosphate is alkalescence, after being combined with polyphosphazene polymer lactic acid, in energy and poly-lactic acid material acid degradation products and improve its bio-compatibility.Calcium phosphate can regulate polylactic acid macromolecular material space structure, and increases composite machinery intensity; Composite after polylactic acid/calcium phosphate is blended is nanoporous structure, and this microcellular structure also can induce the quick growth of bone.Thus polylactic acid/the calcium phosphate composite material in the present invention is the ideal material for degradable people osteocranium bone.
Wherein:
Skull repairing method: because of the reparation of the defect of skull that the factor such as wound and operation causes, only autologous bone lobe, morphologically accomplish completely the same very difficult with former defect.The position of defect of skull, size, shape are different, and carry out traditional moulds in preoperative and art and make by hand being difficult to extremely mate with defective region, particularly moulding titanium plate dummy and former defective region physiological camber are not inconsistent, and after being shaped, bilateral symmetry is not good enough, and cosmetic result is poor.Previously most clinician adopts simple tool to carry out on-the-spot processing and fabricating to titanium net, doctor in the preoperative with design repeatedly in art, cutting, moulding, due to the experience of patient and the impact of tools, cause surgical effect uneven, both delay operating time, often do not reach again symmetrical cosmetic result.And more than 70% patient's defect area is in forehead, geisoma profile and adjacent volume temporoparietal region territory thereof, cosmetic result directly has influence on the psychology of patient and physiological health.
Along with computer and 3D image reconstruction technology application and adopt automatic die to make titanium plate, make moulding more perfect, more accurate.At present in the digitized design platform technology of the titanium alloy skull repairing body of Clinical practice, the advantage of this technology be digital technology in conjunction with CT scan three-dimensional imaging, the preoperative dummy made can be made more accurate.After kposthesis, the symmetry of titanium net dummy and strong laterocranium bone decides the cosmetic result of operation, but the cranioplasty of computer-aided design is when operation designing, just carry out according to the skull information of patient's head CT, give up the information of soft tissue, if the material of implantation is placed between scalp and temporalis, then just cannot mate according to the embedded material of skull information design.
3D printing technique and skull reparation: 3D print and namely increase material manufacturing technology, rely on three Dimensional CAD Design data, by the technology of dispersed material (liquid, powder, silk etc.) successively accumulation principle manufacture entity component.Relative to traditional material removal process technology, increasing material manufacture is one material addition manufacturing process from bottom to top." increase material manufacture " without the need to proembryo and mould, just directly according to computer graphics data, the object of any shape can be generated by the method increasing material, simplify the fabrication schedule of product, shorten the lead time of product, raise the efficiency and reduce costs.The technical characterstic of 3D determines its manufacture field at small lot customization and complex product, as field tool outstanding advantages such as artificial skull printings.
Comprehensively above-mentioned, material involved in the present invention, during for Bone Defect Repari, the mechanical strength that tool strengthens, good bio-compatibility, self-bone grafting function and biodegradability.Prosthese in implantable bone by body automatic absorption, thus avoids the side effect that conventional metals or other non-degradable prosthesis have after wound healing.Manufacture method tool involved in the present invention fast, simple, accurate advantage, clinically, can fast, personalized production adsorbable bone prosthesis, thus benefit bone injury patient.
Accompanying drawing explanation
Fig. 1 is that 3D of the present invention prints biological absorbable skull prosthesis procedure flow chart;
Fig. 2 is biological absorbable bone renovating material nanoporous structure figure of the present invention.As shown in FIG., made by this material, the section (F with H) of prosthese becomes nanometer to micron-sized microcellular structure, and those micropores strengthen with polylactic acid degradation in vivo, are the spaces of self bone cell growth in Bone Defect Repari process.
Fig. 3 compares with implantation instrument (intravascular stent) bio-compatibility in animal blood vessels after month made by non-degradable PEVA/PBMA (A) and degradable poly lactate material (B) for the biological absorbable bone renovating material (C) in the present invention.As shown in FIG., the made intravascular stent of biological absorbable composite in the present invention, in implantation animal blood vessels after one month, the endotheliocyte of its surface coverage thin layer, that the performance of vascular repair is (under C, arrow), then cover with the inflammatory tissue (under A and B, black line) of hypertrophy in the bar of PEVA/PBMA and polylactic acid bracket.A in figure: nonabsorable material PEVA/PBMA composite; B: polyphosphazene polymer lactate material; C: polylactic acid/calcium phosphate composite material.Upper: low power microscope (4X); Under: high power microscope (20X).
Fig. 4 is that the mechanical strength that the biological absorbable bone renovating material in the present invention strengthens compares.As shown in the figure, the obvious enhance mechanical strength of tool compared with independent poly-lactic acid material (blueness) of the biological absorbable bone renovating material (green) in the present invention.
Skeleton serial tissue CT faulted scanning pattern (1mm/ frame) is converted in the present invention to print stl file or can injection moulding cad file process schematic by 3D by Fig. 5.
Fig. 6 is by increasing material facture of the present invention, by the schematic diagram of the artificial skull that biological absorbable bone renovating material is printed as.As shown in the figure, by the biological absorbable wire rod in the present invention, by 3D printing equipment, by the stl file transforming gained in Fig. 5, the biological absorbable skull of printing.
Fig. 7 is the clinical repair process of the present invention for artificial skull.As shown in the figure, damage skull is carried out sequence of CT scan, scan-image is converted into stl file by shown in Fig. 5, and be printed as a complete bio Absorbable rod skull (as shown in Figure 6), in the skull printed, finally take out the artificial osteocomma of damage location, and be implanted to the damage location of patient.
concrete embodiment
The present invention may be used for any bone injury, and for skull, in conjunction with detailed description of the invention, the present invention is described in further detail below, understands the present invention to help those skilled in the art, but is not used for limiting the invention in the application in other bone injury.
Embodiment 1
A kind of biological absorbable material for repairing skull, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (poly (glycolide-lactide)) 10kg and calcium phosphate (amorphous calcium phosphate (ACP)) 90kg.
The composite forming Absorbable rod skull prosthese can by macromolecule and nanofabrication technique, and as super mixer, double screw extruder the method such as to be extruded and obtained, or by chemical method just nanoparticle suspensions obtain in macromolecular material.
The preparation method of described prosthese bone is injection moulding:
A, by damage skull CT/MRI image digitazation, be converted into cad file;
B, on injection machine, by the cad file of above-mentioned conversion, above-mentioned biological absorbable bone renovating material is injection molded into damage skull model;
Obtained Absorbable rod skull is coated in the skull of bone growth inducing material (injured patients's autogenous bone marrow stem cell) implant patient damage.
Embodiment 2
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (polylactic acid (PLA)) 20kg and calcium phosphate (dicalcium phosphate (DCP)) 80kg.
The composite forming Absorbable rod skull prosthese can by macromolecule and nanofabrication technique, and as super mixer, double screw extruder the method such as to be extruded and obtained, or is obtained in macromolecular material by nanoparticle suspensions by chemical method.
The preparation method of described prosthese bone:
A, the CT/MRI image data open source software of damage skull is converted into stl file, or the discernible file of other 3D printers, sets up the model of damage skull;
B, described biological absorbable bone renovating material is processed into the spendable wire rod of 3D printer.
C, the wire rod will be processed in B by melt and dissolved sintering process, by the model set up in A, successively sintered by 3D printer and be superimposed as invented adsorbable artificial skull prosthese.
By obtained Absorbable rod skull, coat in the skull of bone growth inducing material (Osteogenic Stem of artificial In vitro culture) implant patient damage.
Embodiment 3
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (poly-L-lactic acid (PLLA)) 30kg and calcium phosphate (tricalcium phosphate (TCP)) 70kg.
Preparation method with embodiment 1, by the skull of obtained Absorbable rod skull osteocomma implant patient damage.
Embodiment 4
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is Bioabsorbable Polyesters polymer (poly-D, Pfansteihl (PDLA)) complex of 40kg and calcium phosphate (hydroxyapatite five calcium (HAP)) 60kg, described prosthetic surface also scribbles bone growth inducing material (medicine).
Preparation method, with embodiment 2, by obtained Absorbable rod skull, is coated in the skull of bone growth inducing material (osteogenic factor) implant patient damage.
Embodiment 5
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (poly-D, L-Acetic acid, hydroxy-, bimol. cyclic ester) 50kg and calcium phosphate (tetracalcium phosphate carbon monoxide (TTCP)) 50kg.
Preparation method, with embodiment 2, by obtained Absorbable rod skull, is coated in the skull of bone growth inducing material (injured patients's autogenous bone marrow stem cell) implant patient damage.
Embodiment 6
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (poly (glycolide-lactide) (PLGA) 20kg, polylactic acid (PLA) 20kg, poly-L-lactic acid (PLLA) 20kg) 60kg and calcium phosphate (amorphous calcium phosphate (ACP) 20kg, hydroxyapatite five calcium (HAP) 20kg) 40kg
Preparation method, with embodiment 2, by obtained Absorbable rod skull, is coated in the skull of bone growth inducing material (osteogenic factor+medicine) implant patient damage.
Embodiment 7
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is Bioabsorbable Polyesters polymer (poly-L-lactic acid (PLLA) 10kg, poly-D, Pfansteihl (PDLA) 20kg, PGA (PGA) 20kg, poly-D, L-Acetic acid, hydroxy-, bimol. cyclic ester 20kg) complex of 70kg and calcium phosphate (hydroxyapatite five calcium (HAP)) 30kg.
Obtained Absorbable rod skull, with embodiment 1, is coated in the skull of bone growth inducing material (injured patients's autogenous bone marrow stem cell) implant patient damage by preparation method.
Embodiment 8
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (PGA (PGA)) 80kg and calcium phosphate (amorphous calcium phosphate (ACP) 5kg, dicalcium phosphate (DCP) 15kg) 20kg.
Preparation method, with embodiment 2, by obtained Absorbable rod skull, is coated in the skull of bone growth inducing material (Osteogenic Stem of artificial In vitro culture) implant patient damage.
Embodiment 9
A kind of biological absorbable bone renovating material, the constituent of described skull prosthesis is the complex of Bioabsorbable Polyesters polymer (poly-polylactic acid (PLA) 10kg, PGA (PGA) 80kg) 90kg and calcium phosphate (hydroxyapatite five calcium (HAP)) 10kg.
Obtained Absorbable rod skull, with embodiment 2, is coated in the skull of bone growth inducing material (injured patients's autogenous bone marrow stem cell) implant patient damage by preparation method.
Above-described embodiment, just preferred embodiment of the present invention, is not used for limiting the scope of the present invention, therefore all equivalences done with the feature described in the claims in the present invention and principle change or modify, and all should be included within the claims in the present invention scope.

Claims (15)

1. a biological absorbable bone renovating material, is characterized in that, comprises the Bioabsorbable Polyesters polymer and calcium phosphate that calculate in mass ratio, and the mass ratio of described biologically absorbable polymer and calcium phosphate is 1 ~ 99: 99 ~ 1.
2. biological absorbable bone renovating material as claimed in claim 1, it is characterized in that, described Bioabsorbable Polyesters polymer is polyphosphazene polymer lactate material.
3. biological absorbable bone renovating material as claimed in claim 2, is characterized in that, described polyphosphazene polymer lactate material is poly (glycolide-lactide), polylactic acid, poly-L-lactic acid, poly-D, the one or more combination thing in Pfansteihl, PGA, poly-D, L-Acetic acid, hydroxy-, bimol. cyclic ester.
4. biological absorbable bone renovating material as claimed in claim 1, is characterized in that, described calcium phosphate is the one or more combination thing in the amorphous calcium phosphate of Nano grade, dicalcium phosphate, tricalcium phosphate, hydroxyapatite five calcium, tetracalcium phosphate carbon monoxide.
5. an artificial prosthesis bone, is characterized in that, employ biological absorbable bone renovating material described in any one in claim 1-4, described artificial prosthesis bone also comprises bone growth inducing material; Described bone growth inducing material is coated in described biological absorbable bone renovating material surface.
6. as claim 5 states artificial prosthesis bone, it is characterized in that, described bone growth inducing material is the one or more combination thing in injured patients's autogenous bone marrow stem cell, the Osteogenic Stem of artificial In vitro culture, osteogenic factor and medicine.
7. a preparation method for biological absorbable bone renovating material, is characterized in that, extrudes obtained by the Bioabsorbable Polyesters polymer of described amount and calcium phosphate by super mixer, double screw extruder; Or described amount Bioabsorbable Polyesters polymer and calcium phosphate are passed through chemical method, nanoparticle suspensions is obtained in macromolecular material.
8. the preparation method of bone renovating material as claimed in claim 7, it is characterized in that, the mixing speed in described super mixer is more than 1000 revs/min.
9. the preparation method of bone renovating material as claimed in claim 7, is characterized in that, the extrusion temperature that described double screw extruder squeezes is 100 ~ 400 DEG C.
10. the preparation method of bone renovating material as claimed in claim 7, is characterized in that, the positive and negative charge on described chemical method for a change calcium phosphate surface.
The preparation method of 11. bone renovating materials as claimed in claim 7, is characterized in that, described chemical method is add binding agent in composite.
The preparation method of 12. 1 kinds of artificial prosthesis bones, is characterized in that: by the bone renovating material that in claim 7-11, described in any one, biological absorbable bone renovating material preparation method obtains, then is obtained by injection moulding or the facture preparation of increasing material.
The preparation method of 13. artificial prosthesis bones as claimed in claim 12, it is characterized in that, described injection moulding is specially: first by the CT/MRI image digitazation of damaged bone, be converted into cad file, again on injection machine, by the cad file of above-mentioned conversion, above-mentioned biological absorbable bone renovating material is injection molded into the model of damaged bone, obtains described artificial prosthesis bone.
The preparation method of 14. artificial prosthesis bones as claimed in claim 13, is characterized in that, described injection temperature 100 ~ 400 DEG C.
The preparation method of 15. artificial prosthesis bones as claimed in claim 12, it is characterized in that, described increasing material autofrettage is specially:
A. the CT/MRI image data open source software of damaged bone is converted into stl file, or the discernible file of other 3D printers, set up the model of damaged bone;
B. described biological absorbable bone renovating material is processed into the spendable wire rod of 3D printer;
C. with the wire rod that melt and dissolved sintering process will be processed in B, by the model set up in A, successively sinter to be superimposed as by 3D printer and obtain described artificial prosthesis bone.
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