CN116194161A - 开颅手术用非固定型植入物及其制造方法 - Google Patents
开颅手术用非固定型植入物及其制造方法 Download PDFInfo
- Publication number
- CN116194161A CN116194161A CN202180057684.7A CN202180057684A CN116194161A CN 116194161 A CN116194161 A CN 116194161A CN 202180057684 A CN202180057684 A CN 202180057684A CN 116194161 A CN116194161 A CN 116194161A
- Authority
- CN
- China
- Prior art keywords
- styrene
- implant
- growth factor
- poly
- wings
- 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.)
- Pending
Links
- 239000007943 implant Substances 0.000 title claims abstract description 87
- 238000007428 craniotomy Methods 0.000 title claims abstract description 34
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 10
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 43
- 210000003625 skull Anatomy 0.000 claims abstract description 32
- 239000000463 material Substances 0.000 claims abstract description 25
- -1 calcium phosphate compound Chemical class 0.000 claims description 77
- 239000001506 calcium phosphate Substances 0.000 claims description 48
- 229920000642 polymer Polymers 0.000 claims description 36
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 25
- 235000011010 calcium phosphates Nutrition 0.000 claims description 25
- 229920001707 polybutylene terephthalate Polymers 0.000 claims description 23
- 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 description 19
- 238000000034 method Methods 0.000 claims description 15
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 12
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 12
- 229940078499 tricalcium phosphate Drugs 0.000 claims description 12
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 10
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 10
- 239000004743 Polypropylene Substances 0.000 claims description 9
- VSKJLJHPAFKHBX-UHFFFAOYSA-N 2-methylbuta-1,3-diene;styrene Chemical compound CC(=C)C=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 VSKJLJHPAFKHBX-UHFFFAOYSA-N 0.000 claims description 8
- 102000018233 Fibroblast Growth Factor Human genes 0.000 claims description 8
- 108050007372 Fibroblast Growth Factor Proteins 0.000 claims description 8
- 102000003745 Hepatocyte Growth Factor Human genes 0.000 claims description 8
- 108090000100 Hepatocyte Growth Factor Proteins 0.000 claims description 8
- 108090000723 Insulin-Like Growth Factor I Proteins 0.000 claims description 8
- 108010038512 Platelet-Derived Growth Factor Proteins 0.000 claims description 8
- 102000010780 Platelet-Derived Growth Factor Human genes 0.000 claims description 8
- 239000004952 Polyamide Substances 0.000 claims description 8
- 102000013275 Somatomedins Human genes 0.000 claims description 8
- 102000002933 Thioredoxin Human genes 0.000 claims description 8
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 claims description 8
- FACXGONDLDSNOE-UHFFFAOYSA-N buta-1,3-diene;styrene Chemical compound C=CC=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 FACXGONDLDSNOE-UHFFFAOYSA-N 0.000 claims description 8
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 8
- 229940126864 fibroblast growth factor Drugs 0.000 claims description 8
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 8
- 229920001526 metallocene linear low density polyethylene Polymers 0.000 claims description 8
- 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 8
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims description 8
- 229920001281 polyalkylene Polymers 0.000 claims description 8
- 229920002647 polyamide Polymers 0.000 claims description 8
- 229920001610 polycaprolactone Polymers 0.000 claims description 8
- 239000004632 polycaprolactone Substances 0.000 claims description 8
- 239000004926 polymethyl methacrylate Substances 0.000 claims description 8
- 238000007639 printing Methods 0.000 claims description 8
- 229920000468 styrene butadiene styrene block copolymer Polymers 0.000 claims description 8
- 108060008226 thioredoxin Proteins 0.000 claims description 8
- 229940094937 thioredoxin Drugs 0.000 claims description 8
- 238000010146 3D printing Methods 0.000 claims description 7
- YYRMJZQKEFZXMX-UHFFFAOYSA-L calcium bis(dihydrogenphosphate) Chemical compound [Ca+2].OP(O)([O-])=O.OP(O)([O-])=O YYRMJZQKEFZXMX-UHFFFAOYSA-L 0.000 claims description 7
- 229910000150 monocalcium phosphate Inorganic materials 0.000 claims description 7
- 235000019691 monocalcium phosphate Nutrition 0.000 claims description 7
- 229920001155 polypropylene Polymers 0.000 claims description 6
- 239000004698 Polyethylene Substances 0.000 claims description 5
- 230000001154 acute effect Effects 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 229920000573 polyethylene Polymers 0.000 claims description 5
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 4
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 4
- WSSSPWUEQFSQQG-UHFFFAOYSA-N 4-methyl-1-pentene Chemical compound CC(C)CC=C WSSSPWUEQFSQQG-UHFFFAOYSA-N 0.000 claims description 4
- ACYXOHNDKRVKLH-UHFFFAOYSA-N 5-phenylpenta-2,4-dienenitrile prop-2-enoic acid Chemical compound OC(=O)C=C.N#CC=CC=CC1=CC=CC=C1 ACYXOHNDKRVKLH-UHFFFAOYSA-N 0.000 claims description 4
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 4
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 4
- 229920002101 Chitin Polymers 0.000 claims description 4
- 229920001661 Chitosan Polymers 0.000 claims description 4
- 102000008186 Collagen Human genes 0.000 claims description 4
- 108010035532 Collagen Proteins 0.000 claims description 4
- 229920002307 Dextran Polymers 0.000 claims description 4
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims description 4
- 229920002971 Heparan sulfate Polymers 0.000 claims description 4
- 102000002265 Human Growth Hormone Human genes 0.000 claims description 4
- 108010000521 Human Growth Hormone Proteins 0.000 claims description 4
- 239000000854 Human Growth Hormone Substances 0.000 claims description 4
- 239000004962 Polyamide-imide Substances 0.000 claims description 4
- 229920002732 Polyanhydride Polymers 0.000 claims description 4
- 239000004693 Polybenzimidazole Substances 0.000 claims description 4
- 239000005062 Polybutadiene Substances 0.000 claims description 4
- 239000004695 Polyether sulfone Substances 0.000 claims description 4
- 239000004697 Polyetherimide Substances 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- 229920000954 Polyglycolide Polymers 0.000 claims description 4
- 229920000331 Polyhydroxybutyrate Polymers 0.000 claims description 4
- 239000004642 Polyimide Substances 0.000 claims description 4
- 229920002367 Polyisobutene Polymers 0.000 claims description 4
- 229920001710 Polyorthoester Polymers 0.000 claims description 4
- 239000004793 Polystyrene Substances 0.000 claims description 4
- 108010009583 Transforming Growth Factors Proteins 0.000 claims description 4
- 102000009618 Transforming Growth Factors Human genes 0.000 claims description 4
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims description 4
- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 claims description 4
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims description 4
- 229940072056 alginate Drugs 0.000 claims description 4
- 229920000615 alginic acid Polymers 0.000 claims description 4
- 235000010443 alginic acid Nutrition 0.000 claims description 4
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 4
- 229910052586 apatite Inorganic materials 0.000 claims description 4
- JUNWLZAGQLJVLR-UHFFFAOYSA-J calcium diphosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])(=O)OP([O-])([O-])=O JUNWLZAGQLJVLR-UHFFFAOYSA-J 0.000 claims description 4
- 229940043256 calcium pyrophosphate Drugs 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 4
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 4
- 229920001436 collagen Polymers 0.000 claims description 4
- 229960005188 collagen Drugs 0.000 claims description 4
- 229920001577 copolymer Polymers 0.000 claims description 4
- 229960002086 dextran Drugs 0.000 claims description 4
- 235000019821 dicalcium diphosphate Nutrition 0.000 claims description 4
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims description 4
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 4
- 229940038472 dicalcium phosphate Drugs 0.000 claims description 4
- BXOUVIIITJXIKB-UHFFFAOYSA-N ethene;styrene Chemical group C=C.C=CC1=CC=CC=C1 BXOUVIIITJXIKB-UHFFFAOYSA-N 0.000 claims description 4
- 229920002674 hyaluronan Polymers 0.000 claims description 4
- 229960003160 hyaluronic acid Drugs 0.000 claims description 4
- 150000002576 ketones Chemical class 0.000 claims description 4
- 239000001630 malic acid Substances 0.000 claims description 4
- 235000011090 malic acid Nutrition 0.000 claims description 4
- 230000000921 morphogenic effect Effects 0.000 claims description 4
- 229910000392 octacalcium phosphate Inorganic materials 0.000 claims description 4
- VSIIXMUUUJUKCM-UHFFFAOYSA-D pentacalcium;fluoride;triphosphate Chemical compound [F-].[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 VSIIXMUUUJUKCM-UHFFFAOYSA-D 0.000 claims description 4
- 229920001432 poly(L-lactide) Polymers 0.000 claims description 4
- 229920001308 poly(aminoacid) Polymers 0.000 claims description 4
- 229920001485 poly(butyl acrylate) polymer Polymers 0.000 claims description 4
- 229920001084 poly(chloroprene) Polymers 0.000 claims description 4
- 239000005015 poly(hydroxybutyrate) Substances 0.000 claims description 4
- 229920000218 poly(hydroxyvalerate) Polymers 0.000 claims description 4
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 4
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 claims description 4
- 229920002627 poly(phosphazenes) Polymers 0.000 claims description 4
- 229920002492 poly(sulfone) Polymers 0.000 claims description 4
- 229920002401 polyacrylamide Polymers 0.000 claims description 4
- 229920002239 polyacrylonitrile Polymers 0.000 claims description 4
- 229920002312 polyamide-imide Polymers 0.000 claims description 4
- 229920002480 polybenzimidazole Polymers 0.000 claims description 4
- 229920002857 polybutadiene Polymers 0.000 claims description 4
- 239000004417 polycarbonate Substances 0.000 claims description 4
- 229920000515 polycarbonate Polymers 0.000 claims description 4
- 239000000622 polydioxanone Substances 0.000 claims description 4
- 229920006149 polyester-amide block copolymer Polymers 0.000 claims description 4
- 229920000570 polyether Polymers 0.000 claims description 4
- 229920006393 polyether sulfone Polymers 0.000 claims description 4
- 229920001601 polyetherimide Polymers 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 229920001721 polyimide Polymers 0.000 claims description 4
- 229920001195 polyisoprene Polymers 0.000 claims description 4
- 229920001855 polyketal Polymers 0.000 claims description 4
- 229920006324 polyoxymethylene Polymers 0.000 claims description 4
- 229920002223 polystyrene Polymers 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 239000004800 polyvinyl chloride Substances 0.000 claims description 4
- 239000005033 polyvinylidene chloride Substances 0.000 claims description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 108090000623 proteins and genes Proteins 0.000 claims description 4
- 210000000130 stem cell Anatomy 0.000 claims description 4
- 239000011115 styrene butadiene Substances 0.000 claims description 4
- 229920001897 terpolymer Polymers 0.000 claims description 4
- 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 4
- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 claims description 4
- 239000004734 Polyphenylene sulfide Substances 0.000 claims description 3
- 239000003102 growth factor Substances 0.000 claims description 3
- 150000003891 oxalate salts Chemical class 0.000 claims description 3
- 229920003055 poly(ester-imide) Polymers 0.000 claims description 3
- 229920001849 poly(hydroxybutyrate-co-valerate) Polymers 0.000 claims description 3
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims description 3
- 229920000069 polyphenylene sulfide Polymers 0.000 claims description 3
- 150000003890 succinate salts Chemical class 0.000 claims description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 2
- 230000006444 vascular growth Effects 0.000 claims 2
- 102100037681 Protein FEV Human genes 0.000 claims 1
- 101710198166 Protein FEV Proteins 0.000 claims 1
- 229920002125 Sokalan® Polymers 0.000 claims 1
- 239000004584 polyacrylic acid Substances 0.000 claims 1
- 239000005077 polysulfide Substances 0.000 claims 1
- 229920001021 polysulfide Polymers 0.000 claims 1
- 150000008117 polysulfides Polymers 0.000 claims 1
- 230000007547 defect Effects 0.000 abstract description 14
- 210000001519 tissue Anatomy 0.000 abstract description 7
- 239000012620 biological material Substances 0.000 abstract description 3
- 239000002861 polymer material Substances 0.000 abstract description 3
- 239000011153 ceramic matrix composite Substances 0.000 abstract description 2
- 230000009545 invasion Effects 0.000 abstract 1
- 239000002131 composite material Substances 0.000 description 11
- 238000001356 surgical procedure Methods 0.000 description 8
- 229910052751 metal Inorganic materials 0.000 description 7
- 239000002184 metal Substances 0.000 description 7
- 239000002639 bone cement Substances 0.000 description 4
- 210000004556 brain Anatomy 0.000 description 4
- 230000005855 radiation Effects 0.000 description 4
- 238000005452 bending Methods 0.000 description 3
- 239000000919 ceramic Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000010883 osseointegration Methods 0.000 description 3
- KKEYFWRCBNTPAC-UHFFFAOYSA-L terephthalate(2-) Chemical compound [O-]C(=O)C1=CC=C(C([O-])=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-L 0.000 description 3
- 102100022987 Angiogenin Human genes 0.000 description 2
- 101000757236 Homo sapiens Angiogenin Proteins 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229920005615 natural polymer Polymers 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 239000010936 titanium Substances 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- 206010003694 Atrophy Diseases 0.000 description 1
- 102000009024 Epidermal Growth Factor Human genes 0.000 description 1
- 101800003838 Epidermal growth factor Proteins 0.000 description 1
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 1
- 208000003076 Osteolysis Diseases 0.000 description 1
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 1
- 229930182556 Polyacetal Natural products 0.000 description 1
- 229910001069 Ti alloy Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- YIMQCDZDWXUDCA-UHFFFAOYSA-N [4-(hydroxymethyl)cyclohexyl]methanol Chemical compound OCC1CCC(CO)CC1 YIMQCDZDWXUDCA-UHFFFAOYSA-N 0.000 description 1
- 230000037444 atrophy Effects 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000008468 bone growth Effects 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 239000004568 cement Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000002050 diffraction method Methods 0.000 description 1
- 229940116977 epidermal growth factor Drugs 0.000 description 1
- 210000002919 epithelial cell Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 208000029791 lytic metastatic bone lesion Diseases 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 125000005487 naphthalate group Chemical group 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 229920003207 poly(ethylene-2,6-naphthalate) Polymers 0.000 description 1
- 239000002745 poly(ortho ester) Substances 0.000 description 1
- 229920000058 polyacrylate Polymers 0.000 description 1
- 239000011112 polyethylene naphthalate Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007665 sagging Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2875—Skull or cranium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE 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
- B33Y80/00—Products made by additive manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30014—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30112—Rounded shapes, e.g. with rounded corners
- A61F2002/30136—Rounded shapes, e.g. with rounded corners undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30138—Convex polygonal shapes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30138—Convex polygonal shapes
- A61F2002/30143—Convex polygonal shapes hexagonal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30159—Concave polygonal shapes
- A61F2002/30172—T-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30971—Laminates, i.e. layered products
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE 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
- B33Y10/00—Processes of additive manufacturing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Materials Engineering (AREA)
- Manufacturing & Machinery (AREA)
- Inorganic Chemistry (AREA)
- Composite Materials (AREA)
- Neurosurgery (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Molecular Biology (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
本发明涉及一种非固定型植入物,其利用生物材料和骨传导性优异的陶瓷基复合材料以及聚合物材料,因此可以精确地固定到头盖骨和颅骨瓣之间的间隙,并且具有改进的使用便利性;以及涉及制造所述非固定型植入物的方法。所述非固定型植入物包括:可挠性楔部,其可以沿着颅骨瓣的外部形状成型;以及多个翼部,其连接到所述可挠性楔部的上部或下部,并延伸到所述可挠性楔部的两侧表面上。所述多个翼部具有多孔结构,一侧的翼部定位成邻近颅骨瓣且位于颅骨瓣上方,而另一侧的翼部定位成邻近头盖骨且位于头盖骨上方。因此,存在以下优点:通过开颅手术形成的缺损部可以由植入物精确地固定,并且生物相容性、骨粘附性和组织侵入能力得到改善。
Description
技术领域
本发明涉及一种用于填充由开颅手术产生的颅骨和骨瓣之间的间隙的植入物。更具体而言,本发明包括由单独的聚合物或聚合物和陶瓷化合物的复合材料制成的3D打印植入物及其制造方法,该陶瓷化合物具有类似于天然骨的优异的骨传导性。
本发明的开颅手术用非固定植入物通过3D打印技术制造,具有结构可挠性,可以应用于出现缺损的部位,并且可以由于其楔形插入物而精确地结合到缺损。因此,本发明的非固定植入物具有不需要用于固定植入物的附加固定装置的优点。
项目唯一编号:P0008811
政府部门:贸易、工业和能源部
项目管理专业机构:韩国技术进步研究所
研究业务名称:3D打印医疗器械产业技术示范项目
研究业务名称:使用聚合物基生物可降解材料的外科手术用定制3D打印植入物的演示
贡献率:1/1
研究机构:TNR Biofab Co.,Ltd.
研究期间:2019.04.01至2022.12.31
背景技术
对于通过颅骨进行神经外科手术,进行开颅手术以接近患者大脑。在该过程中,由于外科手术过程中的切割,会出现间隙,即骨缺损。骨之间的间隙导致大脑将通过其暴露的风险,因此不能得到安全保护。另外,切口部位的血流可能受阻,导致骨溶解。此外,外科手术后皮肤沿着间隙凹陷,导致患者感到审美上的不满。
为了解决这些问题,传统上,存在用金属网或骨水泥(bone cement)填充间隙的方法。
使用金属网如钛(Ti)或钛合金的手术具有防止皮肤凹陷等一些问题的优点,但具有一些问题,例如不能促进骨组织愈合和需要用于将金属网固定到颅骨的附加固定装置。另外,当进行治疗用放射线照射时,由于金属网的固有特性,放射线不能通过金属网,因此该专利不能接受有效的放射线治疗。此外,来自植入金属的放射线的散射可能导致副作用,例如周围组织的坏死和皮瓣(flap)的萎缩,这可能导致植入物暴露于外部。
作为常规手术的替代方案而使用的用骨水泥填充颅骨凹陷的骨重建部分弥补了使用金属网的常规手术的缺点。然而,使用骨水泥的重建技术由于填充任意形状的颅骨间隙(cranial gap)的长操作时间而给从业者带来不便,并且仍然存在在水泥固化过程中周围组织可能因放热反应而受损的问题。
公开内容
技术问题
为了有效地解决现有技术中出现的问题,本发明提供了一种使用生物材料和骨传导性优异的陶瓷基复合材料以及聚合物的植入物,其中该植入物是可方便地使用并且被配置成安置在骨缺损中的三维非固定植入物。本发明还提供了制造该植入物的方法。
另外,本发明提供了用3D打印机制造的非固定植入物及其制造方法,该植入物精确地安置在由开颅手术产生的缺损中,具有改进的生物相容性和骨结合能力,并允许组织渗透。
技术方案
本发明的一个实施方式的开颅手术用非固定植入物10用于重新附接在脑外科手术期间从颅骨1去除的骨瓣2。该非固定植入物10包括:可挠性楔100,其可变形以符合骨瓣2的外部轮廓;以及多个翼200,其连接到可挠性楔100的上部或下部并从可挠性楔100的两侧延伸。
多个翼200可以具有多孔结构,其中每个翼200包括待设置在骨瓣2上的第一侧翼201和待设置在颅骨1上的第二侧翼202。
可挠性楔100和多个翼200由其中聚合物和磷酸钙化合物以10:0至5:5的重量比混合的材料制成,并且使用FDM 3D打印机通过3D打印制造。
每个翼200具有格子图案的多孔结构。多孔结构包括:第一层,其中多条线在第一方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距;以及第二层,其中多条线在与第一方向成60°至120°的角度的第二方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距。
另外,可挠性楔100由形成在多个翼200之上或之下的多条堆叠线组成。多条堆叠线由交替连接的凸起(“∩”)和凹陷(“U”)组成。多条堆叠线形成为使得相对于底表面倾斜成锐角的A图案线和相对于底表面倾斜成钝角的B图案线彼此堆叠。
在可挠性楔100中,其上端的宽度与其下端的宽度相同,但大于其中间部的宽度。这种设计使得颅骨1和骨瓣2能够可靠地固定。
作为用于可挠性楔100和多个翼200的3D打印的材料之一的聚合物可以是选自由聚乙烯、茂金属-PE(m-PE)、聚丙烯、聚异丁烯、聚-4-甲基戊烯-1、聚丁二烯、聚异戊二烯、聚环辛烯、聚苯乙烯、聚甲基苯乙烯、聚乙烯基萘、苯乙烯-丁二烯(SB)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯-丁烯-苯乙烯(SEBS)、苯乙烯-乙烯-丙烯-苯乙烯、苯乙烯-异戊二烯、苯乙烯-异戊二烯-苯乙烯(SIS)、苯乙烯-丁二烯-丙烯腈(ABS)、苯乙烯-丙烯腈-丙烯酸酯(ASA)、苯乙烯-乙烯、聚氯乙烯(PVC)、聚氯丁烯和聚偏二氯乙烯(PVDC)、聚甲基丙烯酸甲酯(PMMA)、聚丙烯酸丁酯、聚丙烯酸月桂酯、聚硬脂醇乙酸酯、聚丙烯腈、聚丙烯酰胺、聚酰胺、聚酰亚胺、聚酰胺酰亚胺、聚醚酰亚胺、聚酯酰亚胺、聚(醚)酮、聚砜、聚醚砜、聚芳砜、聚苯硫醚、聚苯并咪唑、聚乙内酰脲、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚丙烯(PP)对苯二甲酸酯(polypropylene(PP)terephtalate)、聚萘二甲酸乙二醇酯(polyethylene naphthylate)、聚-1,4-二羟甲基环己烷对苯二甲酸酯、聚羟基苯甲酸酯、聚羟基萘二甲酸酯、聚丙交酯、聚乙交酯、聚己内酯、聚酐、聚酰胺、聚氨酯、聚酯酰胺、聚原酸酯、聚二噁烷酮、聚缩醛、聚缩酮、聚碳酸酯、聚原碳酸酯、聚磷腈、聚羟基丁酸酯、聚羟基戊酸酯、聚亚烷基草酸酯、聚亚烷基琥珀酸酯、聚(苹果酸)、聚(氨基酸)、聚乙烯吡咯烷酮、聚乙二醇、聚羟基纤维素、甲壳素、壳聚糖、聚(L-乳酸)、聚(丙交酯-共-乙交酯)、聚(羟基丁酸酯-共-戊酸酯)、其共聚物及其三元共聚物组成的组中的一种或多种。
另外,磷酸钙化合物可以包括选自由羟基磷灰石(HAP)、碳酸磷灰石、磷酸三钙(TCP)、磷酸氢钙、磷酸一钙、磷酸二钙、磷酸二氢钙、磷酸三钙、磷酸八钙和焦磷酸钙组成的组中的至少一种。
其中聚合物和磷酸钙化合物混合的材料可以进一步包含选自由羧甲基纤维素、硫酸乙酰肝素、透明质酸、胶原、葡聚糖和藻酸盐组成的组中的至少一种天然聚合物材料。
包括聚合物和磷酸钙化合物的材料或包括聚合物、磷酸钙化合物和天然聚合物材料的材料可以进一步包含选自由骨形态发生蛋白(BMP)、表皮生长因子(EGF)、成纤维细胞生长因子(FGF)、转化生长因子(TGFβ)、血小板衍生生长因子(PDGF)、血管内皮生长因子(VEGE)、胰岛素样生长因子(IGF-1)、硫氧还蛋白(TRX)、干细胞因子(SCF)、肝细胞生长因子(HGF)、人生长激素和血管生长素组成的组中的至少一种。
作为本发明的另一个实施方式,提供了一种制造填充由开颅手术产生的颅骨1和骨瓣2之间的间隙的植入物的方法,该方法包括:将聚合物和磷酸钙化合物以10:0至5:5的重量比混合来制备复合材料;使用FDM 3D打印机并使用该复合材料打印多个翼200;并且使用FDM 3D打印机和该复合材料在多个翼200上形成多条堆叠线来形成可挠性楔100。
多个翼200可以具有多孔结构,其中翼200的第一侧翼201设置在骨瓣2上,翼200的第二侧翼202设置在颅骨1上。
多个翼200的打印可以包括:形成第一层,其中多条线在第一方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距;并且形成第二层,其中多条线在与第一方向成60°至120°的角度的第二方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距,其中第一层的形成和第二层的形成依次进行。
在可挠性楔100的形成中,可挠性楔100可以形成为由堆叠在多个翼200之上或之下的多条线组成,其中多条堆叠线可以包括交替连接的凸起(“∩”)和凹陷(“U”),并且多条堆叠线可以包括相对于底表面倾斜成锐角的A图案线和倾斜成钝角的B图案线。
更优选地,可挠性楔100的上端的宽度与可挠性楔100的下端的宽度相同,并且大于可挠性楔100的中间部的宽度。
有益效果
本发明的开颅手术用非固定植入物由包括诸如聚己内酯(PCL)等聚合物的材料制成,从而具有高伸长率。因此,由于非固定植入物的高伸长率,该非固定植入物甚至可以灵活地(flexibly)应用于由开颅手术产生的弯曲缺损。另外,由于非固定植入物具有待插入颅骨缺损中的楔形插入物,因此在插入后无需使用附加固定装置即可固定非固定植入物。这意味着非固定植入物具有精确地结合到缺损的能力。
另外,本发明的非固定植入物的材料可以进一步包括陶瓷化合物,例如磷酸钙。因此,非固定植入物的材料在晶体学和化学上类似于构成实际骨的无机成分,并且具有直接结合到骨的能力和优异的骨传导性。
另外,当将生物可降解物质或生物可降解聚合物用于非固定植入物时,由于在体内被吸收的特性,非固定植入物具有约24个月的分解期,因此不需要单独的去除过程。另外,由于独特的多孔结构,组织可以渗透到植入物中,并且植入物可以被新骨取代或吸收到体内。
附图说明
在图1中,(a)和(b)分别是本发明的开颅手术用非固定植入物的平面图和立体图。
在图2中,(a)和(b)分别是沿图1的I和II方向截取的截面图。
图3是示出本发明的开颅手术用非固定植入物的楔的示例性图案的示意图,其中A图案和B图案交替布置。
图4是示出本发明的开颅手术用非固定植入物的楔的横截面结构的示意图。
图5是示出本发明的开颅手术用非固定植入物的可挠性的照片。
图6是示出通过使用本发明的开颅手术用非固定植入物将骨瓣2重新附接到颅骨1之前和之后的状态的照片。
[附图中附图标记的说明]
1:颅骨
2:骨瓣
10:开颅手术用非固定植入物
100:可挠性楔(Flexible wedge)
200:翼部
201:第一翼
202:第二翼
具体实施方式
在描述本公开的优选实施方式之前,应当注意,在本说明书和所附权利要求中使用的术语和词语不应被解释为限于常规或词典含义,而是应被解释为与本发明的技术思想一致的含义和概念。
将进一步理解的是,当在本说明书中使用时,术语“包括(comprises)”和/或“包含(comprising)”或“包括(includes)”和/或“包含(including)”或“具有(has)”和/或“具有(having)”指定所述特征、区域、整数、步骤、操作、元素和/或组件的存在,但不排除一个或多个其他特征、区域、整数、步骤、操作、元素和/或组件的存在或添加。
此后,将描述本公开的实施方式。然而,本公开的范围不限于下面描述的优选实施方式,并且本领域技术人员可以在不脱离本公开的范围的情况下实现本文描述的内容的各种修改形式。
本发明的开颅手术用非固定植入物以精确地固定由开颅手术产生的缺损的方式构造。非固定植入物具有改进的生物相容性和骨结合能力并允许组织渗透。非固定植入物用FDM 3D打印机制造。
参考图1和2,本发明的一个实施方式的开颅手术用非固定植入物10用于重新附接在脑外科手术期间从颅骨1去除的骨瓣2。非固定植入物10包括:可挠性楔100,其可变形以符合骨瓣2的外部轮廓;以及多个翼200,其连接到可挠性楔100的上部或下部并朝向可挠性楔100的两侧延伸。
多个翼200可以具有多孔结构,其中翼200的第一侧翼201(或202)设置在骨瓣2上,翼200的第二侧翼202(或201)设置在颅骨1上。
可挠性楔100和多个翼200由其中聚合物和磷酸钙化合物以10:0至5:5的重量比混合的混合材料制成,并且使用FDM 3D打印机通过3D打印制造。
作为磷酸钙化合物,优选使用β-磷酸三钙(β-TCP)。用研钵将β-磷酸三钙(β-TCP)粉碎并过筛以具有约100μm的平均粒径。
首先,如图1的平面图(a)和立体图(b)所示,翼200具有多层结构,其中在每层中以一定的间隔布置多条线。即,翼200包括:第一层,其中多条线在第一方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距;以及第二层,其中多条线在与第一方向成60°至120°的角度的第二方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距。
翼200以这样的方式配置,即,由依次堆叠的第一层和第二层组成的基本单元被重复堆叠一至五次。
对于每一层,线宽和线间距可以相同。作为另选,对于每一层,线宽和线间距可以在适当的范围内变化。当构成线具有预定的宽度和间距以便定向排列时,翼不仅具有良好的机械强度,而且具有足够的弹性和可挠性(flexibility)。
如图1所示,翼200优选地具有诸如六边形形状等多边形形状,因此每个翼200的宽度在其中心处最长,其中楔100垂直地形成在其顶部。另外,在翼200中,中心部的左侧和中心部的右侧优选对称。尽管每个翼200优选具有六边形形状,但是翼200的形状不限于此。
楔100通过FDM 3D打印工艺垂直地形成在翼200的中心部的顶部上。优选地,楔100由与翼200相同的材料制成。形成为从翼200的顶部凸出的楔100是线形的,并且相对于水平方向(0°)具有60°至120°的倾斜角。楔100的线间距可以为2mm至3mm(图3的P),并且线间距是均匀且连续的,如同线间距是以单线绘制方式绘制的(参见图3)。
在这种情况下,楔100的一层的高度为100μm至200μm,并且楔100的总高度优选为3mm至8mm。在形成楔100的每一层时,可以通过控制线之间的间距(图3的P)来调节横向可挠性。在这种情况下,优选地,如图3所示,按层交替地提供A图案和B图案。这种布置可以防止植入物仅在一个方向上弯曲或防止植入物具有单向可挠性。
当A图案和B图案交替堆叠时,如图3所示的A图案和B图案层可以每一层交替(例如,A-B-A-B-A-B-...)。作为另选,如表1至3所示,A图案和B图案可以每两层(例如,A-A-B-B-A-A-B-B-...)或每三层(例如,A-A-A-B-B-B-...)交替。在这种情况下,可以根据堆叠规则堆叠总共六层或更多层。如表1至表3所示,堆叠层的数量不一定限于6。
即,可挠性楔100由堆叠在多个翼200的中心部之上或之下的多条线组成。多条线中的每一条具有凸起(“∩”)和凹陷(“U”)交替连接的图案。多条线中的每一条具有相对于底表面倾斜成锐角的A图案或相对于底表面倾斜成钝角的B图案。当A图案的倾斜角为45°至90°并且B图案的倾斜角为135°至90°时,A图案的倾斜角和B图案的倾斜角之和优选等于180°,使得A图案和B图案彼此互补。
[表1]
[表2]
[表3]
图2的(b)中示出了沿在翼200的中心部上凸出的楔100的长度方向(图1的方向I)切割而得的垂直横截面,并且图2的(a)中示出了沿包括楔100的宽度的翼200的最长宽度的方向(即,图1的方向II)切割而得的垂直横截面。
如图2的(a)所示,优选地,可挠性楔100的上端的宽度等于可挠性楔100的下端的宽度,并且大于楔100的中间部的宽度。
在开颅手术期间,楔100被插入骨瓣2和颅骨1之间的间隙中。因此,在上端和下端的宽度大于中间部的宽度的情况下,一旦楔100被插入,楔就可以被稳定地固定。
图4示意性地示出了本发明的具有图3的(a)所示形状的开颅手术非固定植入物10的楔和翼的横截面结构。如上所述,楔的第一层的宽度和楔的最后一层的宽度相同(参见图4,A),并且宽度优选为3mm至10mm。另外,楔的中间部(参见图4,B)相对较窄,并且中间部的宽度优选为2mm至9mm。
具有这种结构的开颅手术非固定植入物由其中聚合物和磷酸钙化合物以10:0至5:5的重量比混合的复合材料制成。
本发明中使用的聚合物包括选自由聚乙烯、茂金属-PE(m-PE)、聚丙烯、聚异丁烯、聚-4-甲基戊烯-1、聚丁二烯、聚异戊二烯、聚环辛烯、聚苯乙烯、聚甲基苯乙烯、聚乙烯基萘、苯乙烯-丁二烯(SB)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯-丁烯-苯乙烯(SEBS)、苯乙烯-乙烯-丙烯-苯乙烯、苯乙烯-异戊二烯、苯乙烯-异戊二烯-苯乙烯(SIS)、苯乙烯-丁二烯-丙烯腈(ABS)、苯乙烯-丙烯腈-丙烯酸酯(ASA)、苯乙烯-乙烯、聚氯乙烯(PVC)、聚氯丁烯和聚偏二氯乙烯(PVDC)、聚甲基丙烯酸甲酯(PMMA)、聚丙烯酸丁酯、聚丙烯酸月桂酯、聚硬脂醇乙酸酯、聚丙烯腈、聚丙烯酰胺、聚酰胺、聚酰亚胺、聚酰胺酰亚胺、聚醚酰亚胺、聚酯酰亚胺、聚(醚)酮、聚砜、聚醚砜、聚芳砜、聚苯硫醚、聚苯并咪唑、聚乙内酰脲、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚丙烯(PP)对苯二甲酸酯、聚萘二甲酸乙二醇酯、聚-1,4-二羟甲基环己烷对苯二甲酸酯、聚羟基苯甲酸酯、聚羟基萘二甲酸酯、聚丙交酯、聚乙交酯、聚己内酯、聚酐、聚酰胺、聚氨酯、聚酯酰胺、聚原酸酯、聚二噁烷酮、聚缩醛、聚缩酮、聚碳酸酯、聚原碳酸酯、聚磷腈、聚羟基丁酸酯、聚羟基戊酸酯、聚亚烷基草酸酯、聚亚烷基琥珀酸酯、聚(苹果酸)、聚(氨基酸)、聚乙烯吡咯烷酮、聚乙二醇、聚羟基纤维素、甲壳素、壳聚糖、聚(L-乳酸)、聚(丙交酯-共-乙交酯)、聚(羟基丁酸酯-共-戊酸酯)、其共聚物及其三元共聚物组成的组中的一种或多种。然而,可用于本发明的聚合物不限于此。
另外,磷酸钙化合物是类似于天然骨的无机成分。作为磷酸钙化合物,可以使用任何磷酸钙而没有特别限制,只要其可以通过传导帮助骨生长即可。
例如,可以使用选自由羟基磷灰石(HAP)、碳酸磷灰石、磷酸三钙(TCP)、磷酸氢钙、磷酸一钙、磷酸二钙、磷酸二氢钙、磷酸三钙、磷酸八钙和焦磷酸钙组成的组中的至少一种。
任选地,除了聚合物和磷酸钙化合物之外,还可以进一步包含至少一种以上的天然聚合物材料,例如羧甲基纤维素、硫酸乙酰肝素、透明质酸、胶原、葡聚糖或藻酸盐。优选地,天然聚合物材料可以以每100重量份聚合物100重量份以下的量包含。
任选地,除了聚合物和磷酸钙化合物之外,还可以优选以每100重量份聚合物1.0重量份以下的量进一步包含选自以下的至少一种:骨形态发生蛋白(bmp)、上皮细胞生长因子(EGF)、成纤维细胞生长因子(FGF)、转换生长因子(TGFβ)、血小板衍生生长因子(PDGF)、血管内皮生长因子(veg)、胰岛素样生长因子(IGF-1)、硫氧还蛋白(TRX)、干细胞因子(SCF)、肝细胞增殖因子(HGF)、人生长激素和血管生长素。
图5示出了当施加物理力以各种方式弯曲植入物时本发明的一个实施方式的开颅手术用非固定植入物10的照片,以研究植入物的构成成分并检查作为植入物的翼和楔的结构特征的可挠性。
当施加物理力时,确认植入物弯曲灵活而不断裂。该确认表明,即使制造了具有各种曲率的开颅手术切口,植入物也可以在填充颅骨1和骨瓣2之间的间隙的同时固定到颅骨1和骨瓣2上(其中翼可以设置有孔以接收用于将植入物固定到颅骨和骨瓣的螺钉)。
在现有植入物的情况下,对应于本发明植入物的楔的中心部具有直棒状结构。因此,当植入物具有足够的机械强度时,现有植入物的可弯曲角度受到限制(即,当机械强度令人满意时,可弯曲角度不够)。在本发明的植入物的情况下,如图1和表1至3可以看出,由于作为本发明特征的楔形中心部,机械强度和可挠性均可以最大化。例如,如图5的(b)所示,本发明的植入物可以弯曲360°。
作为本发明的另一个实施方式,提供了一种制造开颅手术用非固定植入物10的方法。该方法包括:将聚合物和磷酸钙化合物以10:0至5:5的重量比混合来制备复合材料;使用FDM 3D打印机和制备的复合材料打印多个翼200;并且使用FDM 3D打印机和复合材料堆叠多条线来在多个翼200上形成可挠性楔100。
多个翼200具有多孔结构。一侧的翼201设置在骨瓣2上,而另一侧的翼202设置在颅骨1上。翼201和202可以设置有孔以接收用于在开颅手术期间将非固定植入物固定到颅骨和骨瓣的螺钉。
为了使用FDM 3D打印机和其中聚合物和磷酸钙化合物混合的复合材料通过3D打印生产本发明的植入物,首先将聚合物引入混合容器中,然后在160℃±20℃下熔融40分钟,然后称重磷酸钙并与熔融的聚合物混合。为了均匀共混,将混合物以约1200rpm的速度搅拌2分钟。2分钟的搅拌总共重复约六次。
将以这种方式生产的复合材料置于3D打印机的圆筒中并通过500μm的喷嘴喷射。在这种情况下,喷射温度保持在120℃,用于喷射的气动压力保持在500kPa。每层的打印速度是不同的,但是每层的打印速度被控制在700mm/min至1000mm/min的范围内。
图6中示出了以上述方式生产的非固定植入物10的照片。在图6中,(a)是植入前拍摄的照片,(b)是植入后拍摄的照片。可以看出,本发明的开颅手术用非固定植入物10设置在颅骨1和皮瓣2之间以固定颅骨1和皮瓣2。
本公开不限于上述特定实施方式和描述,并且本领域技术人员可以在不脱离所附权利要求中定义的本公开的范围的情况下对其进行各种改变和修改。另外,这种变化可以落入本公开的保护范围内。
工业实用性
本发明旨在通过使用骨传导性良好的陶瓷复合材料和生物材料以及聚合物来提供植入物。具体而言,本发明提供了一种非固定植入物,其被三维设计成能够精确地插入到间隙中并且可以方便地使用。该植入物是一种3D打印的植入物,可以精确地结合到由开颅手术产生的缺损,具有改进的生物相容性和骨结合能力,并允许组织侵入。另外,本发明提供了制造这种植入物的方法。
本发明的开颅手术用非固定植入物由包括诸如聚己内酯(PCL)等聚合物的材料制成,从而具有高伸长率。因此,由于非固定植入物的高伸长率,该非固定植入物甚至可以灵活地应用于由开颅手术产生的弯曲缺损。另外,由于非固定植入物具有待插入颅骨缺损中的楔形插入物,因此在插入后无需使用附加固定装置即可固定非固定植入物。这意味着非固定植入物具有精确地结合到缺损的能力,因此具有工业实用性。
Claims (17)
1.一种开颅手术用非固定植入物,所述植入物用于填充由开颅手术产生的颅骨(1)和骨瓣(2)之间的间隙,所述植入物包括:
可挠性楔(100),其可变形以符合所述骨瓣(2)的外部轮廓;以及
多个翼(200),其连接到所述可挠性楔(100)的上部或下部并延伸到所述可挠性楔(100)的两侧;
其中,所述多个翼(200)具有多孔结构,并且包括待设置在所述骨瓣(2)上的第一侧翼(201)和待设置在所述颅骨(1)上的第二侧翼(202)。
2.如权利要求1所述的植入物,其中所述可挠性楔(100)和所述多个翼(200)由其中聚合物和磷酸钙化合物以10:0至5:5的重量比混合的混合材料制成,并且使用FDM3D打印机通过3D打印制造。
3.如权利要求1所述的植入物,其中所述翼(200)具有格子图案的多孔结构,所述翼包括:
第一层,其中多条线在第一方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距;以及
第二层,其中多条线在相对于所述第一方向具有60°至120°的角度的第二方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距。
4.如权利要求1所述的植入物,其中所述可挠性楔(100)包括形成在所述多个翼(200)之上或之下的多条堆叠线,
所述多条堆叠线包括交替连接的凸起(“∩”)和凹陷(“U”),并且
所述多条堆叠线形成为使得相对于底表面倾斜成锐角的A图案线和相对于底表面倾斜成钝角的B图案线彼此堆叠。
5.如权利要求4所述的植入物,其中在所述可挠性楔(100)中,其上端的宽度等于其下端的宽度,但大于其中间部的宽度。
6.如权利要求2所述的植入物,其中所述聚合物包括选自由聚乙烯、茂金属-PE(m-PE)、聚丙烯、聚异丁烯、聚-4-甲基戊烯-1、聚丁二烯、聚异戊二烯、聚环辛烯、聚苯乙烯、聚甲基苯乙烯、聚乙烯基萘、苯乙烯-丁二烯(SB)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯-丁烯-苯乙烯(SEBS)、苯乙烯-乙烯-丙烯-苯乙烯、苯乙烯-异戊二烯、苯乙烯-异戊二烯-苯乙烯(SIS)、苯乙烯-丁二烯-丙烯腈(ABS)、苯乙烯-丙烯腈-丙烯酸酯(ASA)、苯乙烯-乙烯、聚氯乙烯(PVC)、聚氯丁烯和聚偏二氯乙烯(PVDC)、聚甲基丙烯酸甲酯(PMMA)、聚丙烯酸丁酯、聚丙烯酸月桂酯、聚硬脂醇乙酸酯、聚丙烯腈、聚丙烯酰胺、聚酰胺、聚酰亚胺、聚酰胺酰亚胺、聚醚酰亚胺、聚酯酰亚胺、聚(醚)酮、聚砜、聚醚砜、聚芳砜、聚苯硫醚、聚苯并咪唑、聚乙内酰脲、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚丙烯(PP)对苯二甲酸酯、聚萘二甲酸乙二醇酯、聚-1,4-二羟甲基环己烷对苯二甲酸酯、聚羟基苯甲酸酯、聚羟基萘二甲酸酯、聚丙交酯、聚乙交酯、聚己内酯、聚酐、聚酰胺、聚氨酯、聚酯酰胺、聚原酸酯、聚二噁烷酮、聚缩醛、聚缩酮、聚碳酸酯、聚原碳酸酯、聚磷腈、聚羟基丁酸酯、聚羟基戊酸酯、聚亚烷基草酸酯、聚亚烷基琥珀酸酯、聚(苹果酸)、聚(氨基酸)、聚乙烯吡咯烷酮、聚乙二醇、聚羟基纤维素、甲壳素、壳聚糖、聚(L-乳酸)、聚(丙交酯-共-乙交酯)、聚(羟基丁酸酯-共-戊酸酯)、其共聚物及其三元共聚物组成的组中的一种或多种。
7.如权利要求2所述的植入物,其中所述磷酸钙化合物包括选自由羟基磷灰石(HAP)、碳酸磷灰石、磷酸三钙(TCP)、磷酸氢钙、磷酸一钙、磷酸二钙、磷酸二氢钙、磷酸三钙、磷酸八钙和焦磷酸钙组成的组中的至少一种。
8.如权利要求2所述的植入物,其中所述聚合物和所述磷酸钙化合物混合的混合材料还包含选自由羧甲基纤维素、硫酸乙酰肝素、透明质酸、胶原、葡聚糖和藻酸盐组成的组中的至少一种天然聚合物材料。
9.如权利要求2所述的植入物,其中所述聚合物和所述磷酸钙化合物混合的混合材料还包含选自由骨形态发生蛋白(BMP)、表皮生长因子(EGF)、成纤维细胞生长因子(FGF)、转化生长因子(TGFβ)、血小板衍生生长因子(PDGF)、血管内皮生长因子(VEGE)、胰岛素样生长因子(IGF-1)、硫氧还蛋白(TRX)、干细胞因子(SCF)、肝细胞生长因子(HGF)、人生长激素和血管生长素组成的组中的至少一种。
10.一种制造用于填充由开颅手术引起的颅骨(1)和骨瓣(2)之间的间隙的植入物(10)的方法,所述方法包括:
将聚合物和磷酸钙化合物以10:0至5:5的重量比混合来制备材料;
使用FDM 3D打印机和所述材料打印多个翼(200);并且
使用FDM 3D打印机和所述材料在所述多个翼(200)上堆叠多条线以形成可挠性楔(100),
其中所述多个翼(200)具有多孔结构,其中第一侧翼(201)设置在骨瓣(2)上并且第二侧翼(202)设置在颅骨(1)上。
11.如权利要求10所述的方法,所述多个翼(200)的打印包括:
形成第一层,其中多条线在第一方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距;并且
形成第二层,其中多条线在相对于所述第一方向具有60°至120°的角度的第二方向上延伸并且具有300μm至500μm的宽度和300μm至500μm的线间距,
其中所述第一层的形成和所述第二层的形成依次进行至少两次。
12.如权利要求10所述的方法,其中在所述可挠性楔(100)的形成中,所述可挠性楔(100)包括堆叠在所述多个翼(200)之上或之下的多条线,所述多条线包括交替连接的凸起(“∩”)和凹陷(“U”),并且所述多条线形成为使得相对于底表面倾斜成锐角的A图案线和倾斜成钝角的B图案线堆叠。
13.如权利要求12所述的方法,其中在所述可挠性楔(100)中,其上端的宽度等于其下端的宽度,但大于其中间部的宽度。
14.如权利要求10所述的方法,其中所述聚合物包括选自由聚乙烯、茂金属-PE(m-PE)、聚丙烯、聚异丁烯、聚-4-甲基戊烯-1、聚丁二烯、聚异戊二烯、聚环辛烯、聚苯乙烯、聚甲基苯乙烯、聚乙烯基萘、苯乙烯-丁二烯(SB)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯-丁烯-苯乙烯(SEBS)、苯乙烯-乙烯-丙烯-苯乙烯、苯乙烯-异戊二烯、苯乙烯-异戊二烯-苯乙烯(SIS)、苯乙烯-丁二烯-丙烯腈(ABS)、苯乙烯-丙烯腈-丙烯酸酯(ASA)、苯乙烯-乙烯、聚氯乙烯(PVC)、聚氯丁烯和聚偏二氯乙烯(PVDC)、聚甲基丙烯酸甲酯(PMMA)、聚丙烯酸丁酯、聚丙烯酸月桂酯、聚硬脂醇乙酸酯、聚丙烯腈、聚丙烯酰胺、聚酰胺、聚酰亚胺、聚酰胺酰亚胺、聚醚酰亚胺、聚酯酰亚胺、聚(醚)酮、聚砜、聚醚砜、聚芳砜、聚苯硫醚、聚苯并咪唑、聚乙内酰脲、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚丙烯(PP)对苯二甲酸酯、聚萘二甲酸乙二醇酯、聚-1,4-二羟甲基环己烷对苯二甲酸酯、聚羟基苯甲酸酯、聚羟基萘二甲酸酯、聚丙交酯、聚乙交酯、聚己内酯、聚酐、聚酰胺、聚氨酯、聚酯酰胺、聚原酸酯、聚二噁烷酮、聚缩醛、聚缩酮、聚碳酸酯、聚原碳酸酯、聚磷腈、聚羟基丁酸酯、聚羟基戊酸酯、聚亚烷基草酸酯、聚亚烷基琥珀酸酯、聚(苹果酸)、聚(氨基酸)、聚乙烯吡咯烷酮、聚乙二醇、聚羟基纤维素、甲壳素、壳聚糖、聚(L-乳酸)、聚(丙交酯-共-乙交酯)、聚(羟基丁酸酯-共-戊酸酯)、其共聚物及其三元共聚物组成的组中的一种或多种。
15.如权利要求10所述的方法,其中所述磷酸钙化合物包括选自由羟基磷灰石(HAP)、碳酸磷灰石、磷酸三钙(TCP)、磷酸氢钙、磷酸一钙、磷酸二氢二钙、磷酸三钙、磷酸八钙和焦磷酸钙组成的组中的至少一种。
16.如权利要求10所述的方法,其中所述聚合物和所述磷酸钙化合物混合的混合材料还包含选自由羧甲基纤维素、硫酸乙酰肝素、透明质酸、胶原、葡聚糖和藻酸盐组成的组中的至少一种天然聚合物材料。
17.如权利要求10所述的方法,其中所述聚合物和所述磷酸钙化合物混合的混合材料还包含选自由骨形态发生蛋白(BMP)、表皮生长因子(EGF)、成纤维细胞生长因子(FGF)、转化生长因子(TGFβ)、血小板衍生生长因子(PDGF)、血管内皮生长因子(VEGE)、胰岛素样生长因子(IGF-1)、硫氧还蛋白(TRX)、干细胞因子(SCF)、肝细胞生长因子(HGF)、人生长激素和血管生长素组成的组中的至少一种。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020200097049A KR102354646B1 (ko) | 2020-08-03 | 2020-08-03 | 개두술용 비고정형 임플란트 및 이의 제조 방법 |
KR10-2020-0097049 | 2020-08-03 | ||
PCT/KR2021/008115 WO2022030759A1 (ko) | 2020-08-03 | 2021-06-28 | 개두술용 비고정형 임플란트 및 이의 제조 방법 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN116194161A true CN116194161A (zh) | 2023-05-30 |
Family
ID=80048880
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202180057684.7A Pending CN116194161A (zh) | 2020-08-03 | 2021-06-28 | 开颅手术用非固定型植入物及其制造方法 |
Country Status (6)
Country | Link |
---|---|
US (1) | US20230263935A1 (zh) |
EP (1) | EP4190281A4 (zh) |
JP (1) | JP7389531B2 (zh) |
KR (1) | KR102354646B1 (zh) |
CN (1) | CN116194161A (zh) |
WO (1) | WO2022030759A1 (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024107663A1 (en) * | 2022-11-14 | 2024-05-23 | Poriferous, LLC | Osteotomy gap filling implant |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5545226A (en) | 1992-05-29 | 1996-08-13 | Porex Technologies Corp. | Implants for cranioplasty |
US6197037B1 (en) | 1999-07-29 | 2001-03-06 | John Hunter Hair | Surgical fastener for joining adjacent bone portions |
US20070083268A1 (en) | 2003-11-21 | 2007-04-12 | Osteopore International Pte Ltd | Bioabsorbable plug implants and method for bone tissue regeneration |
CA2733013A1 (en) * | 2008-08-06 | 2010-02-11 | Allosource | Kerf cranial closure methods and device |
US8241336B2 (en) | 2008-10-10 | 2012-08-14 | Z&R Medical, L.L.C. | Craniotomy closure systems |
KR101269127B1 (ko) | 2011-10-18 | 2013-05-29 | 포항공과대학교 산학협력단 | 멤브레인형 인공 지지체 및 이의 제조 방법 |
KR20160094803A (ko) * | 2015-02-02 | 2016-08-10 | 한국기계연구원 | 뼈 재생용 스캐폴드 제조 방법 및 이를 이용하여 제조된 스캐폴드 |
WO2017210695A1 (en) * | 2016-06-03 | 2017-12-07 | Additive Orthopaedics, LLC | Bone fixation devices |
KR20180128227A (ko) * | 2017-05-23 | 2018-12-03 | 한국생산기술연구원 | Fdm-3d 프린터용 필라멘트 복합수지 조성물, fdm-3d 프린터용 필라멘트 제조방법 및 이에 의해 제조된 필라멘트 및 스캐폴드 |
WO2020028268A1 (en) * | 2018-07-30 | 2020-02-06 | Nanochon, Llc | Implantable scaffolds and uses thereof |
KR102115529B1 (ko) * | 2019-07-25 | 2020-05-26 | (주)시지바이오 | Fdm 3d 프린터용 조성물, 이의 제조방법 및 성형품 |
-
2020
- 2020-08-03 KR KR1020200097049A patent/KR102354646B1/ko active IP Right Grant
-
2021
- 2021-06-28 US US18/006,379 patent/US20230263935A1/en active Pending
- 2021-06-28 JP JP2023506179A patent/JP7389531B2/ja active Active
- 2021-06-28 CN CN202180057684.7A patent/CN116194161A/zh active Pending
- 2021-06-28 WO PCT/KR2021/008115 patent/WO2022030759A1/ko active Application Filing
- 2021-06-28 EP EP21853001.2A patent/EP4190281A4/en active Pending
Also Published As
Publication number | Publication date |
---|---|
EP4190281A4 (en) | 2024-01-03 |
EP4190281A1 (en) | 2023-06-07 |
JP2023536255A (ja) | 2023-08-24 |
US20230263935A1 (en) | 2023-08-24 |
JP7389531B2 (ja) | 2023-11-30 |
KR102354646B1 (ko) | 2022-01-25 |
WO2022030759A1 (ko) | 2022-02-10 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP2108331B1 (de) | Implantat zur Implantation in Knochengewebe oder in durch Knochenersatzmaterial ergänztem Knochengewebe | |
CA2327789C (en) | Membrane with tissue-guiding surface corrugations | |
EP2544627B1 (en) | Implants for correcting tissue defects | |
KR20120117856A (ko) | 뼈 신연을 위한 방법 및 기구 | |
CN116194161A (zh) | 开颅手术用非固定型植入物及其制造方法 | |
US11517439B2 (en) | Bioresorbable bone implant and production method | |
US20090222048A1 (en) | Method and apparatus for bone distraction plate | |
Suuronen et al. | Bioresorbable materials for bone fixation: review of biological concepts and mechanical aspects | |
RU2776875C2 (ru) | Биорассасываемый костный имплантат и способ его изготовления |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination |