EP3813898A1 - Biocompatible heat and y-radiation stable medical device lubricant and corrosion preventative - Google Patents
Biocompatible heat and y-radiation stable medical device lubricant and corrosion preventativeInfo
- Publication number
- EP3813898A1 EP3813898A1 EP19744845.9A EP19744845A EP3813898A1 EP 3813898 A1 EP3813898 A1 EP 3813898A1 EP 19744845 A EP19744845 A EP 19744845A EP 3813898 A1 EP3813898 A1 EP 3813898A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- surgical instrument
- ether polymer
- polyphenyl ether
- ring
- alloy
- 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
- 230000007797 corrosion Effects 0.000 title claims abstract description 26
- 238000005260 corrosion Methods 0.000 title claims abstract description 26
- 239000000314 lubricant Substances 0.000 title description 10
- 229920013636 polyphenyl ether polymer Polymers 0.000 claims abstract description 54
- 238000000576 coating method Methods 0.000 claims abstract description 41
- 239000011248 coating agent Substances 0.000 claims abstract description 34
- 229910052751 metal Inorganic materials 0.000 claims abstract description 20
- 239000002184 metal Substances 0.000 claims abstract description 20
- 229920000642 polymer Polymers 0.000 claims description 29
- 238000000034 method Methods 0.000 claims description 19
- 230000005855 radiation Effects 0.000 claims description 13
- 229910001182 Mo alloy Inorganic materials 0.000 claims description 9
- 230000015556 catabolic process Effects 0.000 claims description 7
- 238000006731 degradation reaction Methods 0.000 claims description 7
- 229910001092 metal group alloy Inorganic materials 0.000 claims description 7
- USIUVYZYUHIAEV-UHFFFAOYSA-N diphenyl ether Chemical compound C=1C=CC=CC=1OC1=CC=CC=C1 USIUVYZYUHIAEV-UHFFFAOYSA-N 0.000 claims description 6
- 229910001220 stainless steel Inorganic materials 0.000 claims description 6
- 239000010935 stainless steel Substances 0.000 claims description 6
- 238000005520 cutting process Methods 0.000 claims description 5
- 229910001256 stainless steel alloy Inorganic materials 0.000 claims description 5
- 238000003860 storage Methods 0.000 claims description 4
- 229910001030 Iron–nickel alloy Inorganic materials 0.000 claims description 3
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 3
- 150000003568 thioethers Chemical class 0.000 claims description 3
- 229910052719 titanium Inorganic materials 0.000 claims description 3
- 239000010936 titanium Substances 0.000 claims description 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 2
- 238000012360 testing method Methods 0.000 description 40
- 229920001577 copolymer Polymers 0.000 description 21
- 241001465754 Metazoa Species 0.000 description 20
- -1 Polytetrafluoroethylene Polymers 0.000 description 13
- 239000000463 material Substances 0.000 description 13
- 238000002347 injection Methods 0.000 description 12
- 239000007924 injection Substances 0.000 description 12
- 229910045601 alloy Inorganic materials 0.000 description 9
- 239000000956 alloy Substances 0.000 description 9
- 230000003013 cytotoxicity Effects 0.000 description 7
- 231100000135 cytotoxicity Toxicity 0.000 description 7
- 238000011156 evaluation Methods 0.000 description 7
- 239000000203 mixture Substances 0.000 description 5
- 239000003755 preservative agent Substances 0.000 description 5
- 230000002335 preservative effect Effects 0.000 description 5
- 231100000933 sensitization response Toxicity 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 241000283973 Oryctolagus cuniculus Species 0.000 description 4
- 230000002159 abnormal effect Effects 0.000 description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 4
- 238000001228 spectrum Methods 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 230000009885 systemic effect Effects 0.000 description 4
- 239000003981 vehicle Substances 0.000 description 4
- 241000700198 Cavia Species 0.000 description 3
- ZOKXTWBITQBERF-UHFFFAOYSA-N Molybdenum Chemical compound [Mo] ZOKXTWBITQBERF-UHFFFAOYSA-N 0.000 description 3
- 230000002500 effect on skin Effects 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 230000007794 irritation Effects 0.000 description 3
- 239000011733 molybdenum Substances 0.000 description 3
- 229910052750 molybdenum Inorganic materials 0.000 description 3
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 3
- 229920000570 polyether Polymers 0.000 description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 description 3
- 238000004321 preservation Methods 0.000 description 3
- 239000008159 sesame oil Substances 0.000 description 3
- 235000011803 sesame oil Nutrition 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 231100000331 toxic Toxicity 0.000 description 3
- 230000002588 toxic effect Effects 0.000 description 3
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 3
- 229910052721 tungsten Inorganic materials 0.000 description 3
- 239000010937 tungsten Substances 0.000 description 3
- 208000031648 Body Weight Changes Diseases 0.000 description 2
- SOGAXMICEFXMKE-UHFFFAOYSA-N Butylmethacrylate Chemical compound CCCCOC(=O)C(C)=C SOGAXMICEFXMKE-UHFFFAOYSA-N 0.000 description 2
- 229920002943 EPDM rubber Polymers 0.000 description 2
- 206010015150 Erythema Diseases 0.000 description 2
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- 206010030113 Oedema Diseases 0.000 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000004721 Polyphenylene oxide Substances 0.000 description 2
- 239000004793 Polystyrene Substances 0.000 description 2
- 229920000297 Rayon Polymers 0.000 description 2
- 229910000831 Steel Inorganic materials 0.000 description 2
- 239000004433 Thermoplastic polyurethane Substances 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 210000001142 back Anatomy 0.000 description 2
- 230000004579 body weight change Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000010941 cobalt Substances 0.000 description 2
- 229910017052 cobalt Inorganic materials 0.000 description 2
- GUTLYIVDDKVIGB-UHFFFAOYSA-N cobalt atom Chemical compound [Co] GUTLYIVDDKVIGB-UHFFFAOYSA-N 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000010828 elution Methods 0.000 description 2
- 231100000321 erythema Toxicity 0.000 description 2
- 229920000840 ethylene tetrafluoroethylene copolymer Polymers 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 150000002739 metals Chemical class 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000000178 monomer Substances 0.000 description 2
- 231100000065 noncytotoxic Toxicity 0.000 description 2
- 230000002020 noncytotoxic effect Effects 0.000 description 2
- 231100000252 nontoxic Toxicity 0.000 description 2
- 230000003000 nontoxic effect Effects 0.000 description 2
- 239000005022 packaging material Substances 0.000 description 2
- 229920000747 poly(lactic acid) Polymers 0.000 description 2
- 229920001281 polyalkylene Polymers 0.000 description 2
- 239000004417 polycarbonate Substances 0.000 description 2
- 229920000515 polycarbonate Polymers 0.000 description 2
- 229920000647 polyepoxide Polymers 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920006324 polyoxymethylene Polymers 0.000 description 2
- 229920002223 polystyrene Polymers 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 229920002981 polyvinylidene fluoride Polymers 0.000 description 2
- 239000002964 rayon Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 238000013077 scoring method Methods 0.000 description 2
- 231100000161 signs of toxicity Toxicity 0.000 description 2
- 239000010959 steel Substances 0.000 description 2
- 229920003048 styrene butadiene rubber Polymers 0.000 description 2
- 229920002803 thermoplastic polyurethane Polymers 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- JJTUDXZGHPGLLC-ZXZARUISSA-N (3r,6s)-3,6-dimethyl-1,4-dioxane-2,5-dione Chemical compound C[C@H]1OC(=O)[C@H](C)OC1=O JJTUDXZGHPGLLC-ZXZARUISSA-N 0.000 description 1
- VPVXHAANQNHFSF-UHFFFAOYSA-N 1,4-dioxan-2-one Chemical compound O=C1COCCO1 VPVXHAANQNHFSF-UHFFFAOYSA-N 0.000 description 1
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 description 1
- 125000003903 2-propenyl group Chemical group [H]C([*])([H])C([H])=C([H])[H] 0.000 description 1
- PYSRRFNXTXNWCD-UHFFFAOYSA-N 3-(2-phenylethenyl)furan-2,5-dione Chemical compound O=C1OC(=O)C(C=CC=2C=CC=CC=2)=C1 PYSRRFNXTXNWCD-UHFFFAOYSA-N 0.000 description 1
- SJZRECIVHVDYJC-UHFFFAOYSA-M 4-hydroxybutyrate Chemical compound OCCCC([O-])=O SJZRECIVHVDYJC-UHFFFAOYSA-M 0.000 description 1
- 238000004483 ATR-FTIR spectroscopy Methods 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 241000700199 Cavia porcellus Species 0.000 description 1
- 229920000298 Cellophane Polymers 0.000 description 1
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 description 1
- 238000005033 Fourier transform infrared spectroscopy Methods 0.000 description 1
- JHWNWJKBPDFINM-UHFFFAOYSA-N Laurolactam Chemical compound O=C1CCCCCCCCCCCN1 JHWNWJKBPDFINM-UHFFFAOYSA-N 0.000 description 1
- 229910001311 M2 high speed steel Inorganic materials 0.000 description 1
- 229920000877 Melamine resin Polymers 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 description 1
- 229920000299 Nylon 12 Polymers 0.000 description 1
- 229920002292 Nylon 6 Polymers 0.000 description 1
- 229920002302 Nylon 6,6 Polymers 0.000 description 1
- 239000004696 Poly ether ether ketone Substances 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 229920002614 Polyether block amide Polymers 0.000 description 1
- 239000004642 Polyimide Substances 0.000 description 1
- 229920002367 Polyisobutene Polymers 0.000 description 1
- 229920001710 Polyorthoester Polymers 0.000 description 1
- 229920012196 Polyoxymethylene Copolymer Polymers 0.000 description 1
- 239000004734 Polyphenylene sulfide Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 1
- 241000283984 Rodentia Species 0.000 description 1
- 206010070834 Sensitisation Diseases 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 229920002125 Sokalan® Polymers 0.000 description 1
- 229920000147 Styrene maleic anhydride Polymers 0.000 description 1
- 229920001807 Urea-formaldehyde Polymers 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 1
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 1
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 1
- 229920001893 acrylonitrile styrene Polymers 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 125000001931 aliphatic group Chemical group 0.000 description 1
- 229920003232 aliphatic polyester Polymers 0.000 description 1
- 229920000180 alkyd Polymers 0.000 description 1
- 125000000217 alkyl group Chemical class 0.000 description 1
- 239000013566 allergen Substances 0.000 description 1
- 230000002009 allergenic effect Effects 0.000 description 1
- 125000003368 amide group Chemical group 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 229920001400 block copolymer Polymers 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 description 1
- 229920003086 cellulose ether Polymers 0.000 description 1
- 229920006218 cellulose propionate Polymers 0.000 description 1
- 238000005229 chemical vapour deposition Methods 0.000 description 1
- 229910052804 chromium Inorganic materials 0.000 description 1
- 239000011651 chromium Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000008199 coating composition Substances 0.000 description 1
- 239000007933 dermal patch Substances 0.000 description 1
- 238000003618 dip coating Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 238000004070 electrodeposition Methods 0.000 description 1
- 239000003822 epoxy resin Substances 0.000 description 1
- 229920006242 ethylene acrylic acid copolymer Polymers 0.000 description 1
- 229920005648 ethylene methacrylic acid copolymer Polymers 0.000 description 1
- 239000005038 ethylene vinyl acetate Substances 0.000 description 1
- 229920005680 ethylene-methyl methacrylate copolymer Polymers 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 229920002313 fluoropolymer Polymers 0.000 description 1
- LNEPOXFFQSENCJ-UHFFFAOYSA-N haloperidol Chemical compound C1CC(O)(C=2C=CC(Cl)=CC=2)CCN1CCCC(=O)C1=CC=C(F)C=C1 LNEPOXFFQSENCJ-UHFFFAOYSA-N 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 150000002430 hydrocarbons Chemical class 0.000 description 1
- 229920013821 hydroxy alkyl cellulose Polymers 0.000 description 1
- 150000003949 imides Chemical class 0.000 description 1
- 238000002329 infrared spectrum Methods 0.000 description 1
- 238000007912 intraperitoneal administration Methods 0.000 description 1
- 229920000554 ionomer Polymers 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229910001105 martensitic stainless steel Inorganic materials 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 239000002480 mineral oil Substances 0.000 description 1
- 235000010446 mineral oil Nutrition 0.000 description 1
- 229920001220 nitrocellulos Polymers 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 238000011017 operating method Methods 0.000 description 1
- 238000012946 outsourcing Methods 0.000 description 1
- 150000003891 oxalate salts Chemical class 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- UQGPCEVQKLOLLM-UHFFFAOYSA-N pentaneperoxoic acid Chemical compound CCCCC(=O)OO UQGPCEVQKLOLLM-UHFFFAOYSA-N 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 229920001568 phenolic resin Polymers 0.000 description 1
- 239000005011 phenolic resin Substances 0.000 description 1
- 238000005240 physical vapour deposition Methods 0.000 description 1
- 229920003227 poly(N-vinyl carbazole) Polymers 0.000 description 1
- 229920000090 poly(aryl ether) Polymers 0.000 description 1
- 229920003055 poly(ester-imide) Polymers 0.000 description 1
- 229920001643 poly(ether ketone) Polymers 0.000 description 1
- 229920002627 poly(phosphazenes) Polymers 0.000 description 1
- 229920002432 poly(vinyl methyl ether) polymer Polymers 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 229920002239 polyacrylonitrile Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920002312 polyamide-imide Polymers 0.000 description 1
- 229920002480 polybenzimidazole Polymers 0.000 description 1
- 229920001748 polybutylene Polymers 0.000 description 1
- 229920001610 polycaprolactone Polymers 0.000 description 1
- 229920002530 polyetherether ketone Polymers 0.000 description 1
- 229920001601 polyetherimide Polymers 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
- 229920001721 polyimide Polymers 0.000 description 1
- 229920001228 polyisocyanate Polymers 0.000 description 1
- 239000005056 polyisocyanate Substances 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
- 229920002959 polymer blend Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920006124 polyolefin elastomer Polymers 0.000 description 1
- 229920000069 polyphenylene sulfide Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 229920001290 polyvinyl ester Polymers 0.000 description 1
- 229920001289 polyvinyl ether Polymers 0.000 description 1
- 229920001291 polyvinyl halide Polymers 0.000 description 1
- 229920006215 polyvinyl ketone Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- SCUZVMOVTVSBLE-UHFFFAOYSA-N prop-2-enenitrile;styrene Chemical compound C=CC#N.C=CC1=CC=CC=C1 SCUZVMOVTVSBLE-UHFFFAOYSA-N 0.000 description 1
- 229920005604 random copolymer Polymers 0.000 description 1
- 229920003031 santoprene Polymers 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000008313 sensitization Effects 0.000 description 1
- 230000001235 sensitizing effect Effects 0.000 description 1
- 229920005573 silicon-containing polymer Polymers 0.000 description 1
- 229910001415 sodium ion Inorganic materials 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 125000006850 spacer group Chemical group 0.000 description 1
- 238000004528 spin coating Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- YFHICDDUDORKJB-UHFFFAOYSA-N trimethylene carbonate Chemical compound O=C1OCCCO1 YFHICDDUDORKJB-UHFFFAOYSA-N 0.000 description 1
- 229910052720 vanadium Inorganic materials 0.000 description 1
- LEONUFNNVUYDNQ-UHFFFAOYSA-N vanadium atom Chemical compound [V] LEONUFNNVUYDNQ-UHFFFAOYSA-N 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
-
- 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
- A61L27/04—Metals or alloys
-
- 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
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00836—Material properties corrosion-resistant
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/10—Materials for lubricating medical devices
Definitions
- PPE polyphenyl ether
- Stainless steel and related alloys vary in corrosion resistance based upon their composition and exposure to various environments. Certain medical device alloys require the application of a preservative film to prevent corrosion. Water-based lubricant preservatives are unsuitable for some medical device materials, in particular, articulating instruments that are less corrosion resistant. Straight- chain hydrocarbons and silicone-based lubricants suffer from radiation damage that can render them less effective or toxic. Polytetrafluoroethylene (PTFE) based lubricants cannot withstand gamma radiation at typical sterilizing doses (20-25 kGy) without significant degradation.
- PTFE polytetrafluoroethylene
- PPEs Polyphenyl ethers
- a surgical instrument including a metal surface configured to contact a surgical patient, and a biocompatible polymeric coating over the metal surface, wherein the polymeric coating includes a polyphenyl ether polymer, and wherein the coating slows the rate of corrosion of the metal surface during storage.
- Various embodiments disclosed herein relate to a method of treating a metal surface of a surgical instrument to improve corrosion resistance, wherein the method includes coating the metal surface with a biocompatible polymeric coating, wherein the coating includes a polyphenyl ether polymer.
- the polyphenyl ether polymer is a five-ring polyphenyl ether.
- the metal is a stainless steel or molybdenum alloy.
- the coating is resistant to degradation by gamma radiation.
- the medical device is either sterile or non-sterile.
- FIG. 1 shows the DATR Spectra of Gamma-Sterilized (43-58 kGy) SANTOTUBE® OS-124 Coated Fluted Drums (Anspach Packaged).
- FIG. 2 shows the DATR Spectra of non-sterile SANTOTUBE® OS-124 Coated Fluted Drums (Millstone Packaged).
- FIG. 3 shows the preservation of a non-sterile SANTOTUBE® OS-124 Coated Fluted Drum, 4 weeks post-manufacturing.
- FIG. 4 shows the preservation of a sterile SANTOTUBE® OS-124 Coated Fluted Drum, 4 weeks post-manufacturing.
- the present disclosure provides for the use of polyphenyl ether (PPE)-based polymeric coatings as non-toxic, radiation stable lubricants and corrosion preventatives for medical devices, such as metal surgical instruments configured to contact surgical subjects.
- PPE-based polymeric coatings are formulated to be resistant to degradation by gamma radiation or heat and provides a conformal barrier to corrosion.
- the PPE-based coatings of the present disclosure are biocompatible, can withstand both steam and gamma radiation sterilization and retain biocompatibility following sterilization.
- the PPE-based coatings further exhibit excellent resistance to oxidation, including oxidative resistance above 100°C.
- the present disclosure further provides for surgical instruments which contain at least one metal surface and a biocompatible PPE-based polymeric corrosion resistant coating coated thereon, wherein the coating slows the rate of corrosion during the storage life of the instrument.
- a“polymeric” material is one that contains one or more types of polymers, commonly containing at least 50 wt% to 75 wt%, to 90 wt% to 95 wt% to 99 wt% or even more polymers.
- polymeric materials include those containing a single type of polymer as well as polymer blends.
- polymers are molecules that contain multiple copies of one or more constitutional units, commonly referred to as monomers, and typically contain from 5 to 10 to 25 to 50 to 100 to 500 to 1000 or more constitutional units. Polymers may be, for example, homopolymers, which contain multiple copies of a single constitutional unit, or copolymers, which contain multiple copies of at least two dissimilar constitutional units, which units may be present in any of a variety of distributions including random, statistical, gradient, and periodic (e.g., alternating) distributions.
- the PPE-based polymeric coating of the present disclosure may be used to lubricate surgical instruments or other sterile and non-sterile medical devices.
- Suitable PPE polymers include six-ring polyphenyl ether polymers, five-ring polyphenyl ether polymers, four-ring polyphenyl ether polymers, three- and four-ring oxy- and thioether polymers, three-ring polyphenyl ether polymers, two-ring diphenyl ether polymers, and combinations thereof.
- the PPE-based polymeric coating preferably contains a five-ring polyphenyl ether polymer.
- the PPE-based coating may also contain other polymeric materials selected from: polycarboxylic acid polymers and copolymers including polyacrylic acids; acetal polymers and copolymers; acrylate and methacrylate polymers and copolymers (e.g., n-butyl methacrylate); cellulosic polymers and copolymers, including cellulose acetates, cellulose nitrates, cellulose propionates, cellulose acetate butyrates, cellophanes, rayons, rayon triacetates, and cellulose ethers such as carboxymethyl celluloses and hydroxyalkyl celluloses; polyoxymethylene polymers and copolymers; polyimide polymers and copolymers such as polyether block imides and polyether block amides, polyamidimides, polyesterimides, and polyetherimides; polyamide polymers and copolymers including nylon 6,6, nylon 12, polycaprolactams and polyacrylamides; resins including alkyd resins,
- Preferred polymeric materials of the present disclosure are biocompatible and non-cytotoxic as determined using the MEM Elution subjective scoring method (Grade 0-4), wherein a passing score is Grade 0 or Grade 1. Other tests for biocompatibility and cytotoxicity may also be used and are known to those skilled in the art.
- Preferred polymeric materials also provide corrosion resistance to the coated surgical instrument for at least 4 weeks upon storage of the instrument.
- Preferred polymeric materials further provide gamma-radiation resistance to at least a level of 20 kGy, preferably 40-50 kGy, to the coated surgical instrument so as to prevent degradation of the PPE-based coating that would adversely affect corrosion resistance or biocompatibility of the instrument.
- Specific medical devices that may be lubricated using the PPE-based coating include any surgical instruments having a metal surface.
- Exemplary surgical instruments include surgical scissors and other cutting instruments, electro surgical instruments, cautery instruments, needle holders, osteotomes and periosteotomes, chisels, gouges, rasps, files, saws, reamers, wire twisting forceps, wire cutting forceps, ring handled forceps, tissue forceps, cardiovascular clamps, rongeurs, or any other hard metal instrument having teeth, serrations, a cutting edge or being otherwise susceptible to corrosion.
- Specific hard metals that may be coated with the PPE-based coating of the present disclosure include steel-based materials including stainless steel, titanium or titanium alloy, iron-nickel alloy and molybdenum or molybdenum alloy or combinations thereof.
- Preferred hard metals include stainless steel alloy 15-5PE1, 17-5PE1, 300 series, 400 series; and M series steel molybdenum alloys or combinations thereof.
- Specific examples include high carbon martensitic stainless steel (e.g. Stainless steel Type 440A), high speed tool stainless steels containing molybdenum and tungsten, but not cobalt (e.g. Ml and M2), and high speed tool stainless steel alloys containing molybdenum, chromium, tungsten and vanadium (e.g. M7).
- medical devices that may be lubricated using the PPE-based coating include articulating implantable devices and instruments, including, but not limited to, distractors and adjustable spacers, and softer metallic devices, such as bending templates.
- the polymeric coatings are configured to result in reduced corrosion in certain areas of the instruments relative to other areas.
- some areas of the instrument may be provided with coating materials, while others are not.
- coating materials may be provided which provide differing corrosion protection, for example due to a difference in the composition of the material making up the coating, due to a difference in the thickness of the coating material, and so forth.
- the coating composition and/ or thickness may change abruptly (e.g., in a stepwise fashion) and/ or gradually along the surface of the instrument.
- the PPE-based polymeric coating of the disclosed embodiments may be formed using any of a variety of techniques depending upon the polymer or polymers making up the coatings, including, for example, physical vapor deposition, chemical vapor deposition, electrochemical deposition, layer-by- layer techniques, and coating techniques based on the application of liquid polymer compositions, examples of which include polymer melts, polymer solutions, and curable polymer systems, among other techniques.
- the polymeric coating may be formed using dip-coating, spray coating, web-coating or spin coating.
- the coating may be applied before or after sterilization of the coated instrument and may prevent packaging material from sticking to the instrument.
- the specific polyphenyl ether preservative utilized in the Examples was SANTOTUBE® OS-124 High-Temperature Radiation-resistant Base Fluid, which is a 5-ring polyphenyl ether with exceptionally low volatility and resistance to degradation from heat, oxygen, radiation and chemical attack.
- the hard metal alloy tested in the Examples is M2 steel which contains tungsten and does not contain cobalt.
- polyphenyl ether is as directed in DMR Operating Procedure G01.05.01 Manual Cleaning of Cutters with the exception that instead of the HT-1640-00 oil, the polyphenyl ether SANTOTUBE® OS-124 High-temperature Radiation-resistant Base Fluid is used.
- Cytotoxicity was determined using the MEM Elution subjective scoring method (Grade 0-4) with results reported at 24, 48, and 72 hours post-24-hour extraction. A passing score is Grade 0, Grade 1 or Grade 2. Results of the cytotoxicity study with the above test samples packaged in different packaging are shown in Table 3: [0044] Table 3
- An intracutaneous irritation test was conducted to determine if PPE would leach or be extracted from a test sample and cause local irritation in the dermal tissues of albino rabbits.
- the test sample was diluted at a 1:1 ratio using sesame oil.
- Each animal was weighed and the weight recorded prior to test injection. The fur of the animals was clipped on both sides of the spinal column to expose a sufficient sized area for injection.
- test article and a vehicle control were injected into three rabbits. Each rabbit received five sequential 0.2 mL intracutaneous injections of the test article extract on the right side of the vertebral column and similarly the control vehicle on the left side.
- a test was conducted to evaluate the allergenic potential or sensitizing capacity of a test article containing PPE.
- the test was used as a procedure for the screening of contact allergens in guinea pigs and extrapolating the results to humans.
- mice were treated by the intrap eritoneal route to screen the test article solutions for potential toxic effects as a result of a single-dose systemic injection.
- mice were injected systemically with the test article solution or control sesame oil (SO). The animals were observed for signs of toxicity immediately after injection and at 4, 24, 48 and 72 hours post-injection. The requirements of the test were met if none of the animals treated with the test article had a significantly greater adverse reaction than the animals treated with a vehicle control.
- SO sesame oil
- Molecular stability was determined by observing for changes in the infrared spectra of the neat, non-sterilized and sterilized samples using FTIR-ATR methods.
- the PPE preservative was applied to the internal reflecting element (IRE) directly and the spectrum measured in absorbance mode between 4000 cm 4 and 600 cm 4 in 1 cm 1 increments and 64 co-added scans.
- the butterfly bar was pressed against the IRE and the spectrum obtained using the same wave number range as for the neat sample.
- test devices listed in Tables 5-7 were placed into packaging material and stored under ambient conditions for two weeks (14 days) and then observed for the presence of visible corrosion. If corrosion was observed on the unpreserved samples, then the test was considered completed. Observation of the non-sterile and sterile test devices stored under the same conditions was performed and the presence of visible corrosion reported.
- samples that were cleaned, preserved and packaged by Millstone Medical Outsourcing was implemented as part of the overall evaluation.
- the samples were non-sterile samples.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862683401P | 2018-06-11 | 2018-06-11 | |
PCT/IB2019/054688 WO2019239257A1 (en) | 2018-06-11 | 2019-06-05 | Biocompatible heat and υ-radiation stable medical device lubricant and corrosion preventative |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3813898A1 true EP3813898A1 (en) | 2021-05-05 |
Family
ID=67439269
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19744845.9A Pending EP3813898A1 (en) | 2018-06-11 | 2019-06-05 | Biocompatible heat and y-radiation stable medical device lubricant and corrosion preventative |
Country Status (7)
Country | Link |
---|---|
EP (1) | EP3813898A1 (ja) |
JP (1) | JP7408583B2 (ja) |
CN (1) | CN112261957A (ja) |
AU (1) | AU2019285470A1 (ja) |
BR (1) | BR112020025239A2 (ja) |
CA (1) | CA3103379A1 (ja) |
WO (1) | WO2019239257A1 (ja) |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4981756A (en) * | 1989-03-21 | 1991-01-01 | Vac-Tec Systems, Inc. | Method for coated surgical instruments and tools |
WO1998053922A1 (en) * | 1997-05-27 | 1998-12-03 | Polymer Alloys Llc | Metal corrosion protection with wash coat of polyphenylene oxide |
JPH1147142A (ja) * | 1997-08-07 | 1999-02-23 | Kaijirushi Hamono Kaihatsu Center:Kk | 皮膚切除具 |
US6545097B2 (en) * | 2000-12-12 | 2003-04-08 | Scimed Life Systems, Inc. | Drug delivery compositions and medical devices containing block copolymer |
US7905902B2 (en) * | 2003-06-16 | 2011-03-15 | Ethicon Endo-Surgery, Inc. | Surgical implant with preferential corrosion zone |
DE102004034645A1 (de) * | 2004-07-16 | 2006-02-09 | Ewald Dörken Ag | Korrosionsschutz-Beschichtungsmittel für Metall und Verfahren zur Herstellung hierfür |
US20070224244A1 (en) * | 2006-03-22 | 2007-09-27 | Jan Weber | Corrosion resistant coatings for biodegradable metallic implants |
-
2019
- 2019-06-05 CN CN201980038872.8A patent/CN112261957A/zh active Pending
- 2019-06-05 JP JP2020568707A patent/JP7408583B2/ja active Active
- 2019-06-05 EP EP19744845.9A patent/EP3813898A1/en active Pending
- 2019-06-05 CA CA3103379A patent/CA3103379A1/en active Pending
- 2019-06-05 WO PCT/IB2019/054688 patent/WO2019239257A1/en unknown
- 2019-06-05 BR BR112020025239-5A patent/BR112020025239A2/pt not_active Application Discontinuation
- 2019-06-05 AU AU2019285470A patent/AU2019285470A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
AU2019285470A1 (en) | 2021-01-07 |
JP7408583B2 (ja) | 2024-01-05 |
CA3103379A1 (en) | 2019-12-19 |
JP2021526911A (ja) | 2021-10-11 |
CN112261957A (zh) | 2021-01-22 |
WO2019239257A1 (en) | 2019-12-19 |
BR112020025239A2 (pt) | 2021-03-09 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP0739219B1 (en) | Catheter having a long-lasting antimicrobial surface treatment | |
US5712229A (en) | Waterborne lubricant for teflon products | |
Sethuraman et al. | In vivo biodegradability and biocompatibility evaluation of novel alanine ester based polyphosphazenes in a rat model | |
WO2007058880A2 (en) | Elastomeric article with antimicrobial coating | |
JPH0866471A (ja) | 医療装置用水溶性滑剤 | |
JP2918032B2 (ja) | テフロン製品用水溶性潤滑剤 | |
BR112014024742B1 (pt) | Método para montar um dispositivo médico e composição antimicrobiana | |
JPS62500245A (ja) | 複相ポリマ−組成物 | |
JP6803382B2 (ja) | 外科的用途のための抗菌性組成物 | |
US20220023495A9 (en) | BIOCAMPATIBLE HEAT AND y-RADIATION STABLE MEDICAL DEVICE LUBRICANT AND CORROSION PREVENTATIVE | |
EP3813898A1 (en) | Biocompatible heat and y-radiation stable medical device lubricant and corrosion preventative | |
Veronica et al. | Formulation and evaluation of wound healing gel of white LEADTREE (leucaena LEUCOCEPHALA (lam.) de wit.) leaves extract | |
Butler et al. | Allergic contact dermatitis in dermatologic surgery: review of common allergens | |
CA2574723A1 (en) | Coated surgical needles | |
JP7434283B2 (ja) | 磨耗性治療用コーティング及びこのようなコーティングを含む装置 | |
Larsson et al. | Cannula thrombophlebitis: a study in volunteers comparing polytetrafluoroethylene, polyurethane, and polyamide–ether–elastomer cannulae | |
EP3710030A1 (en) | Compositions and methods for treating intervertebral discs | |
DE60004011T2 (de) | Zusammensetzung von fluorinierten polymeren zur vermeidung chirurgischer verklebungen und gewebeschäden | |
Dasgupta | Silver-coated catheters in peritoneal dialysis | |
EP3562522B1 (de) | Anordnung mit einem resorbierbaren material mit antibakterieller wirkung | |
Indhumathi et al. | Application of antibacterial suture materials in oral and maxillofacial surgery. | |
Fernández-Grajera et al. | Chemical composition of explanted deteriorated nephrostomy polyurethane-catheters through X-ray photoelectron spectroscopy | |
Janani et al. | Triclosan-coated sutures in oral and maxillofacial surgery-An overview. | |
Guerra et al. | Antimicrobial plastic films against SARS‐COV‐2 and pathogenic bacteria | |
Brat | The Impact of Endoscopic Harvesting Methods on Graft Patency in CABG Patients |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: UNKNOWN |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
|
17P | Request for examination filed |
Effective date: 20201207 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
DAV | Request for validation of the european patent (deleted) | ||
DAX | Request for extension of the european patent (deleted) | ||
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: EXAMINATION IS IN PROGRESS |
|
17Q | First examination report despatched |
Effective date: 20221027 |
|
GRAP | Despatch of communication of intention to grant a patent |
Free format text: ORIGINAL CODE: EPIDOSNIGR1 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: GRANT OF PATENT IS INTENDED |
|
RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61L 29/08 20060101ALI20240301BHEP Ipc: A61L 29/02 20060101ALI20240301BHEP Ipc: A61L 27/34 20060101ALI20240301BHEP Ipc: A61L 27/04 20060101ALI20240301BHEP Ipc: A61B 17/00 20060101ALI20240301BHEP Ipc: A61L 31/10 20060101ALI20240301BHEP Ipc: A61L 31/14 20060101ALI20240301BHEP Ipc: A61L 31/02 20060101AFI20240301BHEP |
|
INTG | Intention to grant announced |
Effective date: 20240326 |
|
RAP3 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: DEPUY SYNTHES PRODUCTS, INC. |