CN115154655A - 一种医用金属植入物及其处理方法 - Google Patents
一种医用金属植入物及其处理方法 Download PDFInfo
- Publication number
- CN115154655A CN115154655A CN202210766621.5A CN202210766621A CN115154655A CN 115154655 A CN115154655 A CN 115154655A CN 202210766621 A CN202210766621 A CN 202210766621A CN 115154655 A CN115154655 A CN 115154655A
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- CN
- China
- Prior art keywords
- coating
- phosphate
- medical metal
- calcium
- implant
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
- 239000007943 implant Substances 0.000 title claims abstract description 60
- 229910052751 metal Inorganic materials 0.000 title claims abstract description 35
- 239000002184 metal Substances 0.000 title claims abstract description 35
- 238000003672 processing method Methods 0.000 title abstract description 4
- 239000011248 coating agent Substances 0.000 claims abstract description 96
- 238000000576 coating method Methods 0.000 claims abstract description 96
- 238000006243 chemical reaction Methods 0.000 claims abstract description 37
- 239000002131 composite material Substances 0.000 claims abstract description 33
- 238000001035 drying Methods 0.000 claims abstract description 25
- 238000005507 spraying Methods 0.000 claims abstract description 24
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims abstract description 23
- 239000000126 substance Substances 0.000 claims abstract description 19
- 239000001506 calcium phosphate Substances 0.000 claims abstract description 18
- 238000004140 cleaning Methods 0.000 claims abstract description 17
- 229910000389 calcium phosphate Inorganic materials 0.000 claims abstract description 11
- 235000011010 calcium phosphates Nutrition 0.000 claims abstract description 11
- 239000000843 powder Substances 0.000 claims abstract description 9
- 230000007847 structural defect Effects 0.000 claims abstract description 4
- ZQBZAOZWBKABNC-UHFFFAOYSA-N [P].[Ca] Chemical compound [P].[Ca] ZQBZAOZWBKABNC-UHFFFAOYSA-N 0.000 claims abstract description 3
- 230000008439 repair process Effects 0.000 claims abstract description 3
- 229910000861 Mg alloy Inorganic materials 0.000 claims description 39
- 238000000034 method Methods 0.000 claims description 34
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 23
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 19
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical group [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 17
- 239000011777 magnesium Substances 0.000 claims description 17
- 229910052749 magnesium Inorganic materials 0.000 claims description 16
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 12
- 159000000007 calcium salts Chemical class 0.000 claims description 10
- 238000007750 plasma spraying Methods 0.000 claims description 10
- 239000002253 acid Substances 0.000 claims description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
- 238000012545 processing Methods 0.000 claims description 9
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 claims description 8
- 229910019142 PO4 Inorganic materials 0.000 claims description 8
- 230000015556 catabolic process Effects 0.000 claims description 8
- 238000006731 degradation reaction Methods 0.000 claims description 8
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 claims description 8
- 239000011159 matrix material Substances 0.000 claims description 8
- 229910017604 nitric acid Inorganic materials 0.000 claims description 8
- 239000010452 phosphate Substances 0.000 claims description 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 8
- 230000003746 surface roughness Effects 0.000 claims description 8
- 238000004506 ultrasonic cleaning Methods 0.000 claims description 8
- AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 claims description 7
- 239000000920 calcium hydroxide Substances 0.000 claims description 7
- 229910001861 calcium hydroxide Inorganic materials 0.000 claims description 7
- 238000005498 polishing Methods 0.000 claims description 7
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 7
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 7
- 229940078499 tricalcium phosphate Drugs 0.000 claims description 7
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 6
- 239000001110 calcium chloride Substances 0.000 claims description 6
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 6
- ZCCIPPOKBCJFDN-UHFFFAOYSA-N calcium nitrate Chemical compound [Ca+2].[O-][N+]([O-])=O.[O-][N+]([O-])=O ZCCIPPOKBCJFDN-UHFFFAOYSA-N 0.000 claims description 6
- 238000005488 sandblasting Methods 0.000 claims description 6
- 239000012890 simulated body fluid Substances 0.000 claims description 5
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 4
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 4
- 239000011575 calcium Substances 0.000 claims description 3
- 229910052791 calcium Inorganic materials 0.000 claims description 3
- XQGPKZUNMMFTAL-UHFFFAOYSA-L dipotassium;hydrogen phosphate;trihydrate Chemical compound O.O.O.[K+].[K+].OP([O-])([O-])=O XQGPKZUNMMFTAL-UHFFFAOYSA-L 0.000 claims description 3
- PYLIXCKOHOHGKQ-UHFFFAOYSA-L disodium;hydrogen phosphate;heptahydrate Chemical compound O.O.O.O.O.O.O.[Na+].[Na+].OP([O-])([O-])=O PYLIXCKOHOHGKQ-UHFFFAOYSA-L 0.000 claims description 3
- KMCRQJMZUHNLKJ-NSCUHMNNSA-N (e)-4-(4-nitrophenyl)but-3-en-2-one Chemical compound CC(=O)\C=C\C1=CC=C([N+]([O-])=O)C=C1 KMCRQJMZUHNLKJ-NSCUHMNNSA-N 0.000 claims description 2
- OOSZCNKVJAVHJI-UHFFFAOYSA-N 1-[(4-fluorophenyl)methyl]piperazine Chemical compound C1=CC(F)=CC=C1CN1CCNCC1 OOSZCNKVJAVHJI-UHFFFAOYSA-N 0.000 claims description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 2
- 238000005422 blasting Methods 0.000 claims description 2
- 229960005069 calcium Drugs 0.000 claims description 2
- 239000004227 calcium gluconate Substances 0.000 claims description 2
- 229960004494 calcium gluconate Drugs 0.000 claims description 2
- 235000013927 calcium gluconate Nutrition 0.000 claims description 2
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims description 2
- 238000010288 cold spraying Methods 0.000 claims description 2
- 238000010285 flame spraying Methods 0.000 claims description 2
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims description 2
- 235000019796 monopotassium phosphate Nutrition 0.000 claims description 2
- 229910000392 octacalcium phosphate Inorganic materials 0.000 claims description 2
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims description 2
- 229910000160 potassium phosphate Inorganic materials 0.000 claims description 2
- 235000011009 potassium phosphates Nutrition 0.000 claims description 2
- 229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 claims description 2
- 239000002904 solvent Substances 0.000 claims description 2
- YIGWVOWKHUSYER-UHFFFAOYSA-F tetracalcium;hydrogen phosphate;diphosphate Chemical compound [Ca+2].[Ca+2].[Ca+2].[Ca+2].OP([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O YIGWVOWKHUSYER-UHFFFAOYSA-F 0.000 claims description 2
- CBNBGETWKBUTEL-UHFFFAOYSA-K tripotassium;phosphate;heptahydrate Chemical compound O.O.O.O.O.O.O.[K+].[K+].[K+].[O-]P([O-])([O-])=O CBNBGETWKBUTEL-UHFFFAOYSA-K 0.000 claims description 2
- 150000003013 phosphoric acid derivatives Chemical class 0.000 claims 2
- 230000007797 corrosion Effects 0.000 abstract description 18
- 238000005260 corrosion Methods 0.000 abstract description 18
- 238000002360 preparation method Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 37
- 239000010410 layer Substances 0.000 description 20
- 239000007787 solid Substances 0.000 description 18
- 238000012360 testing method Methods 0.000 description 17
- 239000011259 mixed solution Substances 0.000 description 11
- 239000000047 product Substances 0.000 description 11
- 239000000758 substrate Substances 0.000 description 11
- 239000000463 material Substances 0.000 description 9
- 239000000203 mixture Substances 0.000 description 9
- 239000008213 purified water Substances 0.000 description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 5
- 239000002585 base Substances 0.000 description 5
- 239000012467 final product Substances 0.000 description 5
- 238000001027 hydrothermal synthesis Methods 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 239000002994 raw material Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000004576 sand Substances 0.000 description 4
- 238000009423 ventilation Methods 0.000 description 4
- 239000003513 alkali Substances 0.000 description 3
- 239000010839 body fluid Substances 0.000 description 3
- 210000001124 body fluid Anatomy 0.000 description 3
- 239000000919 ceramic Substances 0.000 description 3
- 235000019797 dipotassium phosphate Nutrition 0.000 description 3
- 229910000396 dipotassium phosphate Inorganic materials 0.000 description 3
- 239000012981 Hank's balanced salt solution Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 2
- KRVSOGSZCMJSLX-UHFFFAOYSA-L chromic acid Substances O[Cr](O)(=O)=O KRVSOGSZCMJSLX-UHFFFAOYSA-L 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- AWJWCTOOIBYHON-UHFFFAOYSA-N furo[3,4-b]pyrazine-5,7-dione Chemical compound C1=CN=C2C(=O)OC(=O)C2=N1 AWJWCTOOIBYHON-UHFFFAOYSA-N 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000011164 ossification Effects 0.000 description 2
- 238000002791 soaking Methods 0.000 description 2
- 239000001488 sodium phosphate Substances 0.000 description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 description 2
- 235000011008 sodium phosphates Nutrition 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 2
- 238000010290 vacuum plasma spraying Methods 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 1
- 239000006004 Quartz sand Substances 0.000 description 1
- WLQXPAUZYVXSNE-UHFFFAOYSA-N [Ca].O[N+]([O-])=O Chemical compound [Ca].O[N+]([O-])=O WLQXPAUZYVXSNE-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 239000003462 bioceramic Substances 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- ZFXVRMSLJDYJCH-UHFFFAOYSA-N calcium magnesium Chemical compound [Mg].[Ca] ZFXVRMSLJDYJCH-UHFFFAOYSA-N 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000003013 cytotoxicity Effects 0.000 description 1
- 231100000135 cytotoxicity Toxicity 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 235000019441 ethanol Nutrition 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 229910001425 magnesium ion Inorganic materials 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000010309 melting process Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 230000035484 reaction time Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000001878 scanning electron micrograph Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 230000003595 spectral effect Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
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- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
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- A61L—METHODS 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
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C22/00—Chemical surface treatment of metallic material by reaction of the surface with a reactive liquid, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals
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- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C24/00—Coating starting from inorganic powder
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- C23C24/04—Impact or kinetic deposition of particles
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- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
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- C23C4/04—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the coating material
- C23C4/10—Oxides, borides, carbides, nitrides or silicides; Mixtures thereof
- C23C4/11—Oxides
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- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C4/00—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge
- C23C4/12—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the method of spraying
- C23C4/129—Flame spraying
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- C—CHEMISTRY; METALLURGY
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- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C4/00—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge
- C23C4/12—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the method of spraying
- C23C4/134—Plasma spraying
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- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials Engineering (AREA)
- Mechanical Engineering (AREA)
- Metallurgy (AREA)
- Organic Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Plasma & Fusion (AREA)
- Physics & Mathematics (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Materials For Medical Uses (AREA)
Abstract
本发明涉及一种医用金属植入物及其处理方法,制备方法包括以下步骤:S1:对所述医用金属植入物进行预处理,得到除去表面氧化层的植入物;S2:对步骤S1中得到的所述除去表面氧化层的植入物进行化学转化处理,形成第一层涂层,所述第一涂层为钙磷复合层;S3:在所述第一层涂层外喷涂磷酸钙盐粉末,喷涂后清洗、干燥得到具有第二层涂层的植入物;S4:将步骤S3中得到的所述具有第二层涂层的植入物进行化学转化处理,以修复所述第一涂层和所述第二涂层的结构缺陷,并形成致密第三层涂层,之后进行清洗、干燥处理。经过处理后的植入物表面形成复合涂层致密性高、耐腐蚀性强,可以稳定地存在于人体环境中使用。
Description
技术领域
本发明涉及医疗器械技术领域,尤其是一种医用金属植入物及其处理方法,通过对医用镁及镁合金进行表面处理,达到产品在体液环境下缓释可控的目的。
背景技术
镁元素作为人体必需元素之一,参与部分的生理活动及代谢。镁及镁合金作为一种可吸收材料,越来越受到临床的关注。不同于高分子类的可吸收材料,镁合金与骨的弹性模量更为接近,不会产生力学屏蔽,同时作为可吸收硬组织植入材料,可在短期内提供一定的力学支撑,长期来看又能实现降解吸收,植入后无需进行二次手术,可以减少患者的心理压力。作为潜在的可广泛应用于植入的医疗器械材料,但也存在许多不足,镁合金实际应用过程中,其耐腐蚀性差,体液环境下极易发生腐蚀降解。接触体液或模拟体液后短期内即发生快速腐蚀,较快丧失了结构的完整性,导致力学强度的降低和失效。同时,大量镁的腐蚀也会使得内植物周围局部的强碱性以及镁离子浓度过高,导致对周围骨组织细胞呈现细胞毒性,影响细胞的功能以及组织愈合。因此,通过镁及镁合金的表面处理,获得具有耐腐蚀性好、生物相容性佳及成骨活性高的表面,来降低和控制镁及镁合金的腐蚀速率,实现整体基体与组织修复相匹配的腐蚀速度及成骨速度将具有重要的意义。
中国专利申请CN112176272A公开了“一种等离子喷涂制备羟基磷灰石涂层的方法”,对表面进行喷砂处理后,采用等离子喷涂羟基磷灰石进行表面覆盖,来改善表面的活性。喷涂涂层为了与基体结合牢固,需要较大的基体粗糙度,否则容易出现结合力不佳导致喷涂的涂层脱落。常规的方式是采用喷砂的方式来进行基体的表面粗糙化来提高粗糙度,但是其存在的问题是喷砂的同时会把砂粒成分残留在基体表面,这些砂粒成分含有氧化铝或者石英砂,用于可吸收镁及镁合金的材料会导致基体材料已经吸收了但是残留了少量砂粒依然存在或者始终无法吸收的情况,存在重大安全风险。
同时,在镁及镁合金的基体材料上采用喷涂结晶态的磷酸钙类生物陶瓷粉末,结晶态的生物陶瓷颗粒在高温熔融过程中,会发生部分的陶瓷组分分解,生成水溶性溶解度较高的TCP(磷酸三钙)及CaO的组成相,涂层的抗降解能力以及致密性显著下降,使得在体液环境下容易发生降解和解离,无法为镁基体提供完整的耐腐蚀性保护。其他技术如采用水热合成以及碱热处理的方法,是通过提高膜层的结晶度从而提高涂层的致密性和耐蚀性,但是此类方法通常会在强酸或者强碱的溶液体系下进行,并且水热或者碱热反应通常均置于密闭耐压的反应釜或者水热釜中反应,同时反应温度一般高于100℃,存在反应设备复杂以及直接反应存在穿透生物陶瓷涂层、损伤更底层涂层和基体的情况。
因此如何在镁及镁合金基体表面通过特殊的处理及构造,来形成结合力好,致密性高,同时具有高耐腐蚀性、生物活性的多层复合涂层对于医用可降解镁合金作为内植物的使用具有重要的临床使用价值。
发明内容
本发明的目的是为了克服现有的医用镁及镁合金材质器械存在的体内腐蚀问题,提供一种医用金属植入物的处理方法,使得植入物表面形成3层复合涂层,该复合涂层与基材的结合力好、致密性高、耐腐蚀性强。
现有技术中一般通过喷涂羟基磷灰石形成耐腐蚀层,但是这种直接喷涂羟基磷灰石的方式,在进行后续的膜转化过程中,溶液会渗透浸入羟基磷灰石层的内层,与基体镁发生反应,形成疏松多孔层,影响到最终整体的涂层结合力。
针对上述问题,本发明首先通过特定的转化膜处理,来获得粗糙度高且溶解度低的镁钙盐涂层,作为打底层,随后通过喷涂过程中形成熔融及半熔融的磷酸钙涂层,与粗糙的打底层形成楔形的机械及物理铆接,同时喷涂过程的应力也利于打底层与基体的结合,最终获得结合力好的复合涂层,也解决了后续与溶液接触时存在的渗入溶液反应问题。
一般医疗器械进行处理追求平整的防护层,本发明另辟蹊径,通过对植入物的2次化学转化处理,形成的表面较为粗糙,整体外表面的粗糙度≥3μm,在微观上呈现楔形结构,即多个针状物密集地交错形成致密的外表层,层与层间相互铆接,具有意想不到的耐腐蚀效果。这是因为通过3层涂层的复合,获得了整体表面膜层的致密性。本发明采用特定的化学转化处理来形成第一层的覆盖膜层,针对第一层膜层中的局部孔隙及缺陷,通过后续整体的喷涂熔融及半熔融的羟基磷灰石来进行二次覆盖,提高致密程度以及膜厚提升阻隔性,随后进行第二次的化学转化处理,消除喷涂层由于成分的改变导致的喷涂膜层局部致密性存在的差异问题,以及水溶性溶解性增加的问题。需要说明的是,由于第二次化学转化采用的复合溶液与第一次化学转化的原料组分相同,因此不会影响第一涂层的原有组成,仅是对第一涂层和第二涂层的结构缺陷进行修复。
具体方案如下:
一种医用金属植入物的处理方法,所述医用金属植入物的基体材质为镁或者镁合金,包括以下步骤:
S1:对所述医用金属植入物进行预处理,得到除去表面氧化层的植入物;
S2:对步骤S1中得到的所述除去表面氧化层的植入物进行化学转化处理,形成第一涂层,所述第一涂层为钙磷复合层;
S3:在所述第一涂层外喷涂磷酸钙盐粉末,喷涂后清洗、干燥得到具有第二涂层的植入物;
S4:将步骤S3中得到的所述具有第二涂层的植入物进行化学转化处理,以修复所述第一涂层和所述第二涂层的结构缺陷,并形成致密第三涂层,之后进行清洗、干燥处理。
进一步的,步骤S1中所述预处理包括表面打磨、超声清洗和干燥,经过预处理后的所述植入物表面粗糙度Ra粗糙度为0.2~1.0μm;优选地,所述超声清洗采用乙醇为溶剂,清洗时间为1-10min,所述干燥在35-45℃下进行。
进一步的,步骤S2和/或S4中所述化学转化处理采用复合溶液对所述植入物进行浸泡,所述复合溶液包括磷酸盐、钙盐、酸和水。
进一步的,所述复合溶液中所述磷酸盐为无水磷酸钾,七水合磷酸钾,磷酸二氢钾,无水磷酸氢二钾,三水合磷酸氢二钾,无水磷酸二氢钠,二水合磷酸二氢钠,无水磷酸氢二钠,或七水合磷酸氢二钠中的至少一种;所述钙盐为氢氧化钙,硝酸钙,氯化钙,或葡萄糖酸钙中的至少一种;所述酸为硝酸,硫酸,盐酸,醋酸,或柠檬酸的至少一种。
进一步的,步骤S2和/或S4中所述复合溶液中所述磷酸盐的浓度为0.3~0.6mol/L,所述钙盐的浓度为0.3~0.5moL/L,所述酸的浓度为0.01mol/L~0.9mol/L,所述复合溶液的pH为2~5;优选地,步骤S2中所述复合溶液的磷酸盐的浓度高于步骤S4中所述复合溶液的磷酸盐的浓度,或者,步骤S2中所述复合溶液的钙盐的浓度高于步骤S4中所述复合溶液的钙盐的浓度。
进一步的,步骤S2中所述化学转化处理的温度为50℃~70℃,处理时间为10min~30min;优选地,所述化学转化处理的温度为55℃~65℃,处理时间为11min~20min。
进一步的,步骤S2中所述第一涂层粗糙度Ra≥3μm。
进一步的,步骤S3中所述喷涂磷酸钙盐粉末,喷涂方式为等离子喷涂、火焰喷涂、冷喷涂中的其中一种,喷涂前无需经喷砂或喷丸处理;所述磷酸钙盐粉末为磷酸三钙,羟基磷灰石,磷酸八钙,磷酸氢钙中至少一种,所述磷酸钙盐粉末经喷涂后融化并重新结晶附着在所述第一涂层表面,结晶度为50-70%。
进一步的,步骤S3中第二层涂层的厚度为50μm~500μm,所述第二层涂层粗糙度Ra为1.0-2.5μm。
本发明还保护所述医用金属植入物的处理方法制备得到的医用金属植入物,所述医用金属植入物表面为楔形结构,表面粗糙度≥3μm,在在模拟体液中浸泡90天后质量降解比率≤10%。
有益效果:
本发明中通过三层复合膜的共同作用,将溶解度较高的TCP及CaO的组成相进行化学转化处理,同时2次化学转化处理不仅提高了涂层与基体的结合力,而且使整体膜层的耐腐蚀性更高、致密更好,能有效减缓复合涂层的溶解和防止镁基体的腐蚀。
本发明制备得到的所述医用金属植入物,表面为楔形结构,表面粗糙度≥3μm,具有可吸收、可控的缓释效果。可吸收指的是该复合涂层为可被人体所降解吸收的无害材料。缓释指的是在该复合涂层保护下,复合涂层的组分以及镁合金基材的降解释放速率是缓慢的,不会导致植入体快速降解至失效。该植入物在模拟体液中浸泡90天后质量降解比率≤10%,模拟体液为PBS或Hanks或D-Hanks或SBF。
附图说明
为了更清楚地说明本发明的技术方案,下面将对附图作简单的介绍,显而易见地,下面描述中的附图仅仅涉及本发明的一些实施例,而非对本发明的限制。
图1为本发明实施例1制备的镁合金样品在放大倍数100倍下的SEM图;
图2为本发明实施例1制备的镁合金样品在放大倍数1000倍下的SEM图;
图3为本发明实施例1制备的镁合金样品的能谱成分图;
图4为本发明对比例1提供的样品水热反应后的实物图。
具体实施方式
下面将更详细地描述本发明的优选实施方式。虽然以下描述了本发明的优选实施方式,然而应该理解,可以以各种形式实现本发明而不应被这里阐述的实施方式所限制。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规产品。在下面的实施例中,如未明确说明,“%”均指重量百分比。
实施例1
一种医用金属植入物的处理方法,所述医用金属植入物为镁合金棒材,包括以下步骤:
S2:预处理后,将处理好后的实心样品浸没于含有0.6mol/L的磷酸二氢钠、0.3mol/L的氯化钙,酸为0.05mol/L柠檬酸,溶液pH为4,其余为水的混合溶液中浸泡15分钟,溶液温度为63℃,制得第一层涂层。测试表面涂层的粗糙度为3.660μm。
S3:真空等离子喷涂羟基磷灰石涂层。采用结晶度为≥95%的羟基磷灰石粉末对S1中制备样品进行等离子喷涂,制得第二层涂层。喷涂后浸没于无水乙醇中,常温超声清洗3min,40℃下通风烘干,采用XRD测试表面羟基磷灰石的结晶度为60%,测试粗糙度为1.210μm。
S4:将喷涂后实心样品,浸没于在0.3mol/L的磷酸氢二钾、0.4mol/L的氢氧化钙,酸为0.01mol/L硝酸,溶液pH为5,其余为水的的混合溶液中浸泡13分钟,溶液温度为60℃,制得第三层涂层。
将制备后样品,浸没于无水乙醇中,常温超声清洗3min,后采用纯化水漂洗后,40℃下通风烘干,即得最终产品。测试表面涂层的粗糙度为3.420μm。
将制备的实心镁合金产品进行检测,图1、图2分别是为样品在放大倍数100倍、1000倍下的SEM图,从中可以看到:
对样品进行表面成分分析,如图3所示,能谱成分图显示为含有Ca、P元素及O元素,符合植入物安全性要求。
将制备的实心镁合金产品称重,重量为0.8032g,随后浸没于Hanks溶液中,于37.0℃恒温下浸泡90天后,烘干后采用200g/L的铬酸溶液褪除腐蚀产物,称重剩余产品为0.7374g,质量降解比率为8.2%。
实施例2
一种医用金属植入物的处理方法,所述医用金属植入物为镁合金棒材,包括以下步骤:
S2:将处理好后的实心样品浸没于含有0.5mol/L的无水磷酸氢二钠、0.6mol/L的氯化钙,酸为0.05mol/L盐酸,溶液pH为3,其余为水的混合溶液中浸泡17分钟,溶液温度为56℃,制得第一层涂层。测试表面涂层的粗糙度为4.236μm。
S3:真空等离子喷涂羟基磷灰石涂层。采用结晶度为≥95%的羟基磷灰石粉末对S1中制备的样品进行等离子喷涂,制得第二层涂层。喷涂后浸没于无水乙醇中,常温超声清洗3min,40℃下通风烘干,采用XRD测试表面羟基磷灰石的结晶度为58%,测试粗糙度为1.584μm。
S4:将喷涂后实心样品,浸没于在0.3mol/L的磷酸氢二钾、0.4mol/L的氢氧化钙,酸为0.01mol/L硝酸,溶液pH为5,其余为水的的混合溶液中浸泡13分钟,溶液温度为50℃,制得第三层涂层。
将制备后样品,浸没于无水乙醇中,常温超声清洗3min,后采用纯化水漂洗后,40℃下通风烘干,即得最终产品。测试表面涂层的粗糙度为4.731μm。
实施例3
一种医用金属植入物的处理方法,所述医用金属植入物为镁合金片材,包括以下步骤:
S1:样品预处理:将镁合金片材原料制备成6mm×10mm的条状样品,经表面打磨去除表面氧化皮,浸没于无水乙醇中,常温超声清洗8min,40℃下通风烘干,测试表面粗糙度0.642μm。
S2:将处理好后的条状样品浸没于含有0.5mol/L的三水合磷酸氢二钾、0.6mol/L的氢氧化钙,酸为0.05mol/L盐酸,其余为水的混合溶液中浸泡20分钟,溶液温度为65℃,制得第一层涂层。测试表面涂层的粗糙度为4.594μm。
S3:真空等离子喷涂羟基磷灰石涂层。采用结晶度为≥95%的羟基磷灰石粉末对S1中制备的样品进行等离子喷涂,制得第二层涂层。喷涂后浸没于无水乙醇中,常温超声清洗3min,40℃下通风烘干,采用XRD测试表面羟基磷灰石的结晶度为62%,测试粗糙度为1.394μm。
S4:将喷涂后实心样品,浸没于在0.3mol/L的磷酸氢二钾、0.4mol/L的氢氧化钙,酸为0.01mol/L硝酸,其余为水的的混合溶液中浸泡10分钟,溶液温度为60℃,制得第三层涂层。
将制备后样品,浸没于无水乙醇中,常温超声清洗3min,后采用纯化水漂洗后,40℃下通风烘干,即得最终产品。测试表面涂层的粗糙度为3.627μm。
实施例4
一种医用金属植入物的处理方法,所述医用金属植入物为镁合金圆环,包括以下步骤:
S1:样品预处理:将镁合金圆环,经表面打磨去除表面氧化皮,浸没于无水乙醇中,常温超声清洗6min,35℃下通风烘干,测试表面粗糙度0.327μm。
S2:将处理好后的镁合金圆环浸没于含有0.4mol/L的七水合磷酸氢二钠、0.4mol/L的氯化钙,酸为0.08mol/L盐酸,其余为水的混合溶液中浸泡25分钟,溶液温度为68℃,制得第一层涂层。测试表面涂层的粗糙度为4.481μm。
S3:真空等离子喷涂羟基磷灰石涂层。采用结晶度为≥95%的羟基磷灰石粉末对S1中制备的样品进行等离子喷涂,制得第二层涂层。喷涂后浸没于无水乙醇中,常温超声清洗3min,40℃下通风烘干,采用XRD测试表面羟基磷灰石的结晶度为55%,测试粗糙度为1.047μm。
S4:将喷涂后实心样品,浸没于在0.3mol/L的磷酸氢二钠、0.3mol/L的氯化钙,酸为0.03mol/L盐酸,其余为水的的混合溶液中浸泡10分钟,溶液温度为58℃,制得第三层涂层。
将制备后样品,浸没于无水乙醇中,常温超声清洗3min,后采用纯化水漂洗后,40℃下通风烘干,即得最终产品。测试表面涂层的粗糙度为3.579μm。
实施例5
一种医用金属植入物的处理方法,所述医用金属植入物为镁合金棒材,包括以下步骤:
S2:将处理好后的实心样品浸没于含有0.6mol/L的磷酸氢二钾、0.5mol/L的硝酸钙,酸为0.06mol/L硝酸,其余为水的混合溶液中浸泡15分钟,溶液温度为70℃,制得第一层涂层。测试表面涂层的粗糙度为4.574μm。
S3:真空等离子喷磷酸三钙涂层。采用磷酸三钙粉末对S1中制备的样品进行等离子喷涂,制得第二层涂层。喷涂后浸没于无水乙醇中,常温超声清洗3min,40℃下通风烘干,采用XRD测试表面结晶度为60%,测试粗糙度为1.954μm。
S4:将喷涂后实心样品,浸没于在0.3mol/L的磷酸氢二钾、0.3mol/L的氢硝酸钙,酸为0.02mol/L硝酸,其余为水的的混合溶液中浸泡12分钟,溶液温度为60℃,制得第三层涂层。
将制备后样品,浸没于无水乙醇中,常温超声清洗3min,后采用纯化水漂洗后,40℃下通风烘干,即得最终产品。测试表面涂层的粗糙度为3.492μm。
对比例1
取实施例1中步骤S3中获得样品,该样品未进行步骤S4。将样品浸没于Hanks溶液中,于37.0℃恒温下浸泡90天后,烘干后采用200g/L的铬酸溶液褪除腐蚀产物,计算质量降解比率为90.5%。
另取样品,将其浸没于水热反应釜中,其中溶液成分为0.2mol/L磷酸钠,溶液pH为12.6,之后将反应釜密闭锁紧,放置在恒温烘箱内,反应温度为180℃,反应时间为15小时,反应结束后开启反应釜,发现涂层已和镁基体剥离,如图4所示,显示水热反应溶液穿透磷酸钙涂层及转化膜层与镁基体反应并将磷酸钙盐涂层顶裂。
对比例2
参照实施例1,区别在于不进行步骤S2,即按照以下过程进行处理:
S2:进行真空等离子喷涂羟基磷灰石涂层。采用结晶度为≥95%的羟基磷灰石粉末对S1中制备样品进行等离子喷涂。喷涂后浸没于无水乙醇中,常温超声清洗3min,40℃下通风烘干。
S3:将喷涂后实心样品,浸没于在0.3mol/L的磷酸氢二钾、0.4mol/L的氢氧化钙,酸为0.01mol/L硝酸,溶液pH为5,其余为水的的混合溶液中浸泡13分钟,溶液温度为60℃。
将制备后样品,浸没于无水乙醇中,常温超声清洗3min,后采用纯化水漂洗后,40℃下通风烘干,即得对比产品。
将对比样品浸没于水热反应釜中,其中溶液成分为0.2mol/L磷酸钠,溶液pH为12.6,之后将反应釜密闭锁紧,放置在恒温烘箱内,反应温度为180℃,反应时间为15小时,反应结束后开启反应釜,发现涂层已和镁基体剥离。
以上详细描述了本发明的优选实施方式,但是,本发明并不限于上述实施方式中的具体细节,在本发明的技术构思范围内,可以对本发明的技术方案进行多种简单变型,这些简单变型均属于本发明的保护范围。
另外需要说明的是,在上述具体实施方式中所描述的各个具体技术特征,在不矛盾的情况下,可以通过任何合适的方式进行组合。为了避免不必要的重复,本发明对各种可能的组合方式不再另行说明。
此外,本发明的各种不同的实施方式之间也可以进行任意组合,只要其不违背本发明的思想,其同样应当视为本发明所公开的内容。
Claims (10)
1.一种医用金属植入物的处理方法,所述医用金属植入物的基体材质为镁或者镁合金,其特征在于:包括以下步骤:
S1:对所述医用金属植入物进行预处理,得到除去表面氧化层的植入物;
S2:对步骤S1中得到的所述除去表面氧化层的植入物进行化学转化处理,形成第一涂层,所述第一涂层为钙磷复合层;
S3:在所述第一涂层外喷涂磷酸钙盐粉末,喷涂后清洗、干燥得到具有第二涂层的植入物;
S4:将步骤S3中得到的所述具有第二涂层的植入物进行化学转化处理,以修复所述第一涂层和所述第二涂层的结构缺陷,并形成致密第三涂层,之后进行清洗、干燥处理。
2.根据权利要求1所述医用金属植入物的处理方法,其特征在于:步骤S1中所述预处理包括表面打磨、超声清洗和干燥,经过预处理后的所述植入物表面粗糙度Ra粗糙度为0.2~1.0μm;优选地,所述超声清洗采用乙醇为溶剂,清洗时间为1-10min,所述干燥在35-45℃下进行。
3.根据权利要求1所述医用金属植入物的处理方法,其特征在于:步骤S2和/或S4中所述化学转化处理采用复合溶液对所述植入物进行浸泡,所述复合溶液包括磷酸盐、钙盐、酸和水。
4.根据权利要求3所述医用金属植入物的处理方法,其特征在于:所述复合溶液中所述磷酸盐为无水磷酸钾,七水合磷酸钾,磷酸二氢钾,无水磷酸氢二钾,三水合磷酸氢二钾,无水磷酸二氢钠,二水合磷酸二氢钠,无水磷酸氢二钠,或七水合磷酸氢二钠中的至少一种;所述钙盐为氢氧化钙,硝酸钙,氯化钙,或葡萄糖酸钙中的至少一种;所述酸为硝酸,硫酸,盐酸,醋酸,或柠檬酸的至少一种。
5.根据权利要求3所述医用金属植入物的处理方法,其特征在于:步骤S2和/或S4中所述复合溶液中所述磷酸盐的浓度为0.3~0.6mol/L,所述钙盐的浓度为0.3~0.5moL/L,所述酸的浓度为0.01mol/L~0.9mol/L,所述复合溶液的pH为2~5;优选地,步骤S2中所述复合溶液的磷酸盐的浓度高于步骤S4中所述复合溶液的磷酸盐的浓度,或者,步骤S2中所述复合溶液的钙盐的浓度高于步骤S4中所述复合溶液的钙盐的浓度。
6.根据权利要求3所述医用金属植入物的处理方法,其特征在于:步骤S2中所述化学转化处理的温度为50℃~70℃,处理时间为10min~30min;优选地,所述化学转化处理的温度为55℃~65℃,处理时间为11min~20min。
7.根据权利要求3-6任一项所述医用金属植入物的处理方法,其特征在于:步骤S2中所述第一涂层粗糙度Ra≥3μm。
8.根据权利要求1所述医用金属植入物的处理方法,其特征在于:步骤S3中所述喷涂磷酸钙盐粉末,喷涂方式为等离子喷涂、火焰喷涂、冷喷涂中的其中一种,喷涂前无需经喷砂或喷丸处理;所述磷酸钙盐粉末为磷酸三钙,羟基磷灰石,磷酸八钙,磷酸氢钙中至少一种,所述磷酸钙盐粉末经喷涂后融化并重新结晶附着在所述第一涂层表面,结晶度为50-70%。
9.根据权利要求8所述医用金属植入物的处理方法,其特征在于:步骤S3中第二层涂层的厚度为50μm~500μm,所述第二层涂层粗糙度Ra为1.0-2.5μm。
10.权利要求1-9任一项所述医用金属植入物的处理方法制备得到的医用金属植入物,其特征在于:所述医用金属植入物表面为楔形结构,表面粗糙度≥3μm,在在模拟体液中浸泡90天后质量降解比率≤10%。
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