Materi Metalurgi Biomaterial [PDF]

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Pengantar biomaterial logam Konsep metalurgi dan pilihan material ---------Hendra Hermawan Associate Professor, Materials Engineering, Laval University, Canada https://ca.linkedin.com/school/universite-laval/



Sasaran pembelajaran Di akhir kuliah, peserta akan mampu: ▪



memahami beberapa konsep metalurgi sebagai dasar pemilihan material untuk aplikasi kedokteran (biomaterial)



▪



mengenal berbagai jenis logam dan paduan yang dipakai untuk biomaterial



▪



mengetahui proses pembuatan, jenis kegagalan dan contoh desain implan logam



Bacaan sebelumnya: ▪



Pengenalan pada biomaterial Unduh disini



Photo: Dental implant illustration, https://wwwfuchscom-94ba.kxcdn.com/fileadmin/se/Shared_images/927x424px/X-ray_implant_1_927x424px.png



H. Hermawan



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H. Hermawan



Anatomi logam Struktur mikro



Komposisi kimia Paduan Ti-6Al-4V ELI (ASTM F-136) Ti + 5.5-6.5% Al, 3.5-4.5% V, max: 0.25% Fe, 0.13% O, 0.08% C, 0.05% N



doi:10.1002/9781119296126.ch271



Alpha



Beta



Struktur kristal



www.nobelbiocare.com



Proses pembuatan https://www.youtube.com/watch?v=_v7AncbtMK0 www.schoolphysics.co.uk



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H. Hermawan



Komposisi kimia



PFM : porcelaine-fused-to-metal



O'Brien, W.J., Dental Materials and Their Selection, Quintessence, 2011. Photo: Dental surgery, https://www.careersinhealthcare.com/wp-content/uploads/2018/10/Oral-and-Maxillofacial-Surgeon.jpeg



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Pengujian komposisi kimia Sifat pengujian



Nama alat



Analisis merusak sampel



AAS (atomic absorption spectroscopy) ICP-MS (inductively coupled plasma-mass spectroscopy) ICP-AES (ICP-atomic emission spectroscopy)



Semi merusak



LA-ICP-MS (laser abrasion ICP-MS) SIMS (secondary ion mass spectroscopy) OES (optical emission spectroscopy)



IR combustion (infra red) Tidak merusak



EDS (energy dispersive X-ray spectroscopy) WDS (wavelength dispersive X-ray spectroscopy) XRF (X-ray fluorescence spectroscopy) NAA (neutron activation analysis) PIXE (particle induced X-ray emission spectroscopy) XPS (X-ray photoelectron spectroscopy)



Uo, et al. Applications of X-ray fluorescence analysis (XRF) to dental and medical specimens. Japanese Dental Science Review 2015, 51, 2. ASTM E1282: Standard Guide for Specifying the Chem. Comp. and Selecting Sampling Practices and Quantitative Analysis Methods for Metals, Ores, and Related Materials. Photo: Principle of spectrophotometer, https://i.ytimg.com/vi/pxC6F7bK8CU/maxresdefault.jpg



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H. Hermawan



Mikro XRF dan XPS



Fig. 8. A histological image and elemental distribution images of a oral squamous cell carcinoma specimen using SR-XRF.



Fig. 4. XPS spectra of the oxide layers formed during PEO in the CaP (a) and CaMgP (b) solutions.



*SR = synchrotron radiation



www.bruker.com



Fig. 7. SR-XRF spectra.



Uo, et al. Applications of X-ray fluorescence analysis (XRF) to dental and medical specimens. Japanese Dental Science Review 2015, 51, 2. Sowa, et al. DC plasma electrolytic oxidation treatment of gum metal for dental implants. Electrochimica Acta 2019, 302, 10.



www.fsg.ulaval.ca



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H. Hermawan



Paduan logam Contoh: Amalgam (Ag-Sn-Cu), stainless steel (Fe-Cr-Ni-C), Nitinol (Ni-Ti), paduan kobalt-krom (Co-Cr), paduan titanium (Ti-6Al-4V), dst. Paduan logam = larutan padat atom logam dengan logam/non-logam



Peleburan/pengecoran



www.wikipedia.org



Metalurgi serbuk



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H. Hermawan



Struktur mikro logam Logam cair → pengintian → kristal logam → butir logam → logam padat



Struktur mikro C (Ag-28.1%Cu)



890oC



A



B



C



O'Brien, W.J., Dental Materials and Their Selection, Quintessence, 2011. Tian, et al. Microstructures, strengthening mechanisms and fracture behavior of Cu–Ag alloys processed by high-pressure torsion. Acta Materialia 2012, 60, 269.



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Analisis struktur mikro Analisis struktur mikro: Pengukuran butir, identifikasi fasa, identifikasi orientasi kristal (tekstur), identifikasi riwayat proses metalurgi, penyelidikan kegagalan, dsb.



Fig. 13-5. Normal grain structure of cast gold alloy after softening heat treatment. (Original magnification x100).



Fig. 12-6. SEM micrograph of Dispersalloy amalgam, (a) Ag3Sn; (b) Ag-Cu eutectic; (c) ’ phase (Cu6Sn5); (d) ’ phase (Ag2Hg3); (e)  phase (Cu3Sn). (Original mag. x1000).



Fig. 4. Electron backscatter diffraction (EBSD) pole figure map of the investigated Ti-6Al-4V rod, heat-treated prior to the caliber-rolling.



𝑦 = 0 +𝐾𝑑 −1/2



Hard phases vs. soft phases



Slip planes vs. deformation



O'Brien, W.J., Dental Materials and Their Selection, Quintessence, 2011. Lee, et al. Manufacturing Ultrafine-Grained Ti-6Al-4V Bulk Rod Using Multi-Pass Caliber-Rolling. Metals 2015, 5, 777.



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Teknik metalografi



H. Hermawan



Pilih dan potong spesimen → mounting → ampelas → poles halus → etsa → pengamatan mikroskop Contoh tutorial: https://www.youtube.com/watch?v=UuHofNW40Yw&t=12s



ASTM E3: Standard Guide for Preparation of Metallographic Specimens. Photo: Metallography lab, https://www.technologynetworks.com/analysis/product-news/leco-corporation-renews-focus-on-improving-customer-experience-317022



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Mikroskop Mikroskop optik



Mikroskop elektron (SEM)



https://meijitechno.com



Versi lebih maju: Mikroskop konfokal (CLSM), mikroskop Raman, mikroskop digital, dll.



www.semtechsolutions.com



Fungsi tambahan: EDAX, EBSD, ToF-SIMS, FIB, FESEM, dsb. Untuk turun ke skala nano: TEM, AFM, dsb.



Photo: 1 martensit in  phase of Cu-26Zn-5Al, https://www.georgevandervoort.com/wp-content/uploads/2019/06/13_cu_26_per_zn_5_per_al-32.png



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XRD dan AFM



Fig. 1. XRD patterns of different Ti-Ag alloys.



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Fig. 5. In situ AFM images of CoCrMo alloy under electrochemical control in PBS solution with pH 7.4: (a) after 120 min at OCP, (c) after 10 min at 0.5 Vsat Ag/AgCl.



Fungsi: XRD : identifikasi fasa, tegangan, dll. AFM : profil permukaan, nanomekanik, elektrokimia, dll. https://mse.engr.uconn.edu



www.azonano.com



Chen, et al. Effect of nano/micro-Ag compound particles on the bio-corrosion, antibacterial properties and cell biocompatibility of Ti-Ag alloys. Mater Sci Eng C 2017, 75, 906. Bettini, et al. Influence of metal carbides on dissolution behavior of biomedical CoCrMo alloy: SEM, TEM and AFM studies. Electrochimica Acta 2011, 56, 9413.



H. Hermawan



Uji tarik



www.simscale.com www.instron.us



ASTM E8: Standard Test Methods for Tension Testing of Metallic Materials. Powers, J.M., Wataha, J.C., Dental Materials: Foundations and Applications, Mosby, 2016.



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H. Hermawan



Uji tarik



www.totalmateria.com



Necking



Fracture



Patah getas



ASTM E8: Standard Test Methods for Tension Testing of Metallic Materials. Brelle, et al. Precious Palladium-Aluminium-Based Alloys with High Hardness and Workability. Platinum Metals Review 2009, 53, 189.



Patah ulet



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Uji keras Alat uji keras mikro Vickers/Knoop



www.911metallurgist.com



ASTM E384: Standard Test Method for Microindentation Hardness of Materials.



www.alliedhightech.com



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Uji keras Metoda mikro Vickers



www.industrialheating.com



https://sites.ualberta.ca



Metoda lain: ▪ ASTM E10: Standard Test Method for Brinell Hardness of Metallic Materials. ▪ ASTM E18: Standard Test Methods for Rockwell Hardness of Metallic Materials. ▪ ASTM E92: Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials. Konversi nilai kekerasan: ASTM E140: Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness, Superficial Hardness, Knoop Hardness, Scleroscope Hardness, and Leeb Hardness.



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Quiz



Paduan titanium Ti-6Al-4V dikenal memilki dua fasa: alpha dan beta. Alat karakterisasi apa yang dapat memberikan informasi kehadiran suatu fasa kristalin dalam logam? A. B. C. D.



ICP-MS XRD AFM XPS



Photo: Château Frontenac, Québec: https://www.nationalgeographic.com/travel/destinations/north-america/canada/quebec/quebec-city/



H. Hermawan



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Biomaterial



https://media.infoforpatients.com



www.soactivesofast.com



Photo: Medical implants illustration, https://pbs.twimg.com/media/Dd7wgwNVMAAWoev.jpg



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H. Hermawan



Logam



www.syntellix.de



www.newdentalimplants.org



www.depuysynthes.com



ASTM F-136 J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



ASTM F-75



www.osatechnology.com



ASTM F-138



ASTM F-1185



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Magnesium Absorbable magnesium implant: ▪ assists healing (bone fracture, blood vessel occlusion) ▪ degrades and absorbed



▪ no stress shielding effect ▪ no need for 2nd surgery



Standard ASTM F3160-16 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants F3268-18 Standard Guide for in vitro Degradation Testing of Absorbable Metals



Hermawan, H. Updates on the research and development of absorbable metals for biomedical applications. Progress in Biomaterials 2018, 7, 93



H. Hermawan



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H. Hermawan



Titanium



www.garuda-indonesia.com



www.acumed.net



www.zimmer.com



ASTM F-136



J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



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Titanium Alpha Ti



www.ujp.cz



Alpha/beta Ti alloy



Apa pengaruh elemen ini terhadap cp-Ti? http://vacaero.com



J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



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Titanium



H. Hermawan



Standard ASTM F0067-00 Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) F0136-02A Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) F0620-00 Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants F1108-04 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)



F1295-05 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) F1341-99 Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications F1580-01 Specification for Titanium and Titanium-6Aluminum-4Vanadium Alloy Powders for Coatings of Surgical Implants F1713-03 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) F1813-01 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120) F2063-00 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants F2066-01 Specification for Wrought Titanium-15Molybdenum Alloy for Surgical Implant Applications (UNS R58150) F2146-01 Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)



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H. Hermawan



Paduan Co-Cr



Cr : ketahanan korosi, Cr2O3 Mo : kinerja tribologi, kekerasan suhu tinggi, ketahanan pitting Ni : penyetabil fasa austenite (non-magnetic) W : kekerasan, kinerja tribologi



www.kulzer.com



As cast 60Co-30Cr-6Mo Giacchi et al., Mater Charact 2011, 62, 53



J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



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H. Hermawan



Paduan Co-Cr



www.depuysynthes.com



ASTM F-75



3X baja karbon (AISI 1018)



www.fxrxinc.com



J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



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Paduan Co-Cr



H. Hermawan



Standard ASTM F0075-01 Specification for Cobalt-28Chromium-6Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) F0090-01 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) F0562-02 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) F0563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) F0688-00 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) F0799-02 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) F0961-03 Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) F1058-02 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008) F1091-02 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire [UNS R30605] F1377-04 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) F1537-00 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloy for Surgical Implants



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H. Hermawan



Stainless steel Struktur mikro austenit



Material serba guna http://core.materials.ac.uk



ASTM F-138



A guide to stainless steel, available online at: http://www.csidesigns.com/PDFs/SSSguide.pdf



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H. Hermawan



Stainless steel Fe-Cr-Ni + low C



Austenite + ferrite



Kawat gigi, pelat tulang, stent, dll.



AISI 316L



http://core.materials.ac.uk



www.outokumpu.com



+Mo, N → super SS + PH stainless steel Kawat gigi, bracket, dll.



Fe-Cr + low C



Fe-Cr + high C www.twi-global.com



AISI 420



AISI 430



Pisau dan peralatan bedah www.outokumpu.com



www.outokumpu.com



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Stainless steel



H. Hermawan



Standard ASTM F0138-03 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) F0139-03 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) F0621-02 Specification for Stainless Steel Forgings for Surgical Implants F0745-00 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications F0899-02 Specification for Stainless Steels for Surgical Instruments F1314-01 Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) F1325-91R02 Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods F1350-02 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) F1586-02 Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)



F2181-02A Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants F2229-02 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) F2257-03 Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)



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H. Hermawan



Polimer Application



Properties and design requirements



Polymers used



Dental



▪



PMMA-based resins for fillings/prosthesis polyamides poly(Zn acrylates)



▪ ▪



stability and corrosion resistance, plasticity strength and fatigue resistance, coating activity good adhesion/integration with tissue low allergenicity



Ophthalmic



▪ ▪



gel or film forming ability, hydrophilicity oxygen permeability



polyacrylamide gels PHEMA and copolymers



Orthopedic



▪



strength and resistance to mechanical restraints and fatigue good integration with bones and muscles



PE, PMMA PLA, PGA, PLGA



silicones, Teflon, poly(urethanes), PEO



▪ ▪



fatigue resistance, lubricity, sterilizability lack of thrombus, emboli formation lack of chronic inflammatory response



Drug delivery



▪ ▪



appropriate drug release profile compatibility with drug, biodegradability



PLGA, EVA, silicones, HEMA, PCPP-SA



Sutures



▪



good tensile strength, strength retention flexibility, knot retention, low tissue drag



silk, catgut, PLGA, PTMC-GA, PP, nylon, PB-TE



▪



▪



Cardiovascular



▪



▪



Pediatric implants www.dovepress.com



Absorbable screws www.dsm.com



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H. Hermawan



Polimer



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ASTM F-1925



PE inserts J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



http://mpg.berkeley.edu



Polimer



H. Hermawan



Standard ASTM F0639-98AR03 Specification for Polyethylene Plastics for Medical Applications F0641-98AR03 Specification for Implantable Epoxy Electronic Encapsulants F0648-04 Specification for Ultra-High-Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants F0702-98AR03 Specification for Polysulfone Resin for Medical Applications



F0703-96R02 Specification for Implantable Breast Prostheses F0754-00 Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes F0755-99R05 Specification for Selection of Porous Polyethylene for Use in Surgical Implants F0881-94R00 Specification for Silicone Elastomer Facial Implants F0997-98AR03 Specification for Polycarbonate Resin for Medical Applications F1579-02E01 Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications F1781-03 Specification for Elastomeric Flexible Hinge Finger Total Joint Implants F1839-01 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments F1855-00R05 Specification for Polyoxymethylene (Acetal) for Medical Applications



F1876-98R03E01 Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications F1925-99R05 Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants F2026-02 Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications F2313-03 Specification for Virgin Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide



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H. Hermawan



Biokeramik Standard ASTM



F0603-00 Specification for High-Purity Dense Aluminum Oxide for Medical Application F1088-04A Specification for Beta-Tricalcium Phosphate for Surgical Implantation F1185-03 Specification for Composition of Hydroxylapatite for Surgical Implants F1581-99 Specification for Composition of Anorganic Bone for Surgical Implants F1609-03 Specification for Calcium Phosphate Coatings for Implantable Materials



F2224-03 Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants F2393-04 Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications



J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998.



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H. Hermawan



Biokeramik Jenis



Keistimewaan



Penggunaan



Alumina



▪



Lebih dari 2.5 juta femoral heads telah diimplankan di seluruh dunia. Sangat keras dan kaku, gesekan dan keausan rendah Bioinert: respon imun rendah, tidak lengket dengan membrane fibrous



▪ ▪



Mampu berikatan secara kimia dengan jaringan (tulang) Getas, kekuatan tekan rendah Bioaktif: menstimulasi sel pembentuk tulang



▪



Struktur menyerupai mineral tulang Formasinya tergantung pada rasio Ca/P, air, pH, pengotor dan suhu Biodegradable: terdegradasi dalam tubuh



▪



▪ ▪



Bioglass



▪ ▪ ▪



Calcium phosphates



▪ ▪



▪



▪ ▪



▪



▪



▪



Femoral head, knee prosthesis Lapisan porus untuk femoral stem Porous spacers untuk revision surgery Dental crowns and bridges



Ideal untuk pengisi semen tulang dan pelapisan Bioaktivitas tergantung komposisi relatif SiO2, CaO and Na2O



www.morgantechnicalceramics.com



SiO2



Lapisan implan logam, katup jantung penghambat clotting Perbaikan tulang dan pengisi tulang karena trauma atau tumor Perbaikan dan fusi cacat maxillofacial dan dental



A: Bonding within 30 days



B C



A D CaO



B: Nonbonding, reactivity too low C: Nonbonding, reactivity too high D: Bonding



Na2O



J. Black, G. Hastings, Handbook of Biomaterials Properties, Chapman and Hall, London, 1998. Sola, et al. Heat treatment of Na2O‐CaO‐P2O5‐SiO2 bioactive glasses: Densification processes and postsintering bioactivity. J Biomed Mater Res A 2012, 100, 305.



34



Quiz



Di antara material berikut, mana yang dapat menjadi pilihan terbaik untuk membuat pelat kraniofasial? A. B. C. D.



Platina Paduan Ti-6Al-4V Paduan Co-Cr-W-Ni Baja tahan karat jenis 316L



Photo: Lake Louise, Canada, https://r-cf.bstatic.com/data/xphoto/1182x887/116/11685085.jpg?size=S



H. Hermawan



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H. Hermawan



Proses pembuatan 3D printing



Pemesinan



https://sinterex.com www.cmmmagazine.com



Penempaan Pengecoran



www.shinetechimplant.com



www.dentalcastingalloys.com



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3D printing



https://www.youtube.com/watch?v=1IC6HuAwO3Q



H. Hermawan



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H. Hermawan



Pengecoran



www.weldguru.com



solidification



http://i00.i.aliimg.com/img/pb/462/816/369/369816462_537.jpg



as cast microstructure



www.hss.edu/



final microstructure



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H. Hermawan



Perlakuan panas



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Pengerasan: 1. Pemanasan (T, t, atmosfir tgt. jenis paduan) 2. Pendinginan cepat (quenching) 3. Aging (T, t, atmosfir tgt. jenis paduan) → Formasi fasa keras (martensit, presipitat, dll.) Pelunakan: 1. Pemanasan (T, t, atmosfir tgt. jenis paduan) 2. Pendinginan lambat (dalam tungku)



Fig. 1. Schematic heat treatment route for the TTHZ alloy.



→ Formasi fasa lunak (ferit, dsb.) → Pelepasan tegangan → Pembesaran butir



Lin, et al. Effects of solution treatment and aging on the microstructure, mechanical properties, corrosion resistance of a β type Ti–Ta–Hf–Zr alloy. RSC Advances 2017, 7, 12309. Photo: Heat treatment oven, https://industria.airliquide.it/sites/industry_it/files/2020/01/27/trattamenti_termici_mobile.jpg



Pelapisan



H. Hermawan



Berbagai jenis pelapisan pada titanium untuk memperbaiki integrasi dengan tulang



Civantos, et al. Titanium Coatings and Surface Modifications: Toward Clinically Useful Bioactive Implants. ACS Biomaterials Science & Engineering 2017, 3, 1245. Photo: Spray coating, https://www.glassflake.com/wp-content/uploads/2019/04/Powder-Coating-1349x901.jpg



40



Quiz



Strategi apakah yang dapat dipakai untuk memperbaiki hemokompatibilitas dari implan logam? A. B. C. D.



Menghindari sterilisasi dengan autoclave Mengubah komposisi kimia logam Melapisi logam dengan bahan anti-clotting Memberikan perlakuan panas



Photo: Vancouver landscape: https://i.pinimg.com/originals/b6/02/6c/b6026cf0af6a97b1d2fbdedff42eccf8.jpg



H. Hermawan



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Kegagalan biomaterial



Respon tubuh Pembebanan Gesekan Korosi



Boutrand J-P. Biocompatibility and Performance of Medical Devices. Woodhead Publishing, 2012. Photo: Total knee arthroplasty illustration, https://www.webmd.com/osteoarthritis/ss/slideshow-knee-replacement



H. Hermawan



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Keausan



H. Hermawan



▪ Dari 402,051 tindakan operasi implan panggul, tipe metal-on-metal diketahui lebih cepat gagal karena keausan dengan laju revisi selama 5 tahun sebesar 6.2%, dibanding 2.3% untuk tipe ceramic-on-ceramic dan 1.7% untuk tipe metal-on-plastic (National Joint Registry of England and Wales). ▪ Akibat gesekan, partikel kecil ion logam dapat terlepas dari implan dan merembes ke aliran darah, dan dapat menyebabkan kerusakan tulang (osteolysis) dan otot, juga kemungkinan masalah neurologik. Smith, et al. Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. The Lancet 2012, 379, 1199. Photo: Osteoarthritis illustration, https://i0.wp.com/cdn-prod.medicalnewstoday.com/content/images/articles/320/320951/osteoarthritis-of-the-knee.jpg



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H. Hermawan



Patah dan kelelahan Faktor penyebab patah dan kelelahan pada implan: pembebanan statik dan dinamik, juga korosi (stress/fatigue corrosion)



Pedicular screws



Femoral contoured plate



Interlocking screws



Syndesmotic screws



Minal Tapadia. Orthopedic Hardware and Complications. https://radiologykey.com/orthopedic-hardware-and-complications/. Photo: Bone plates and screws, https://www.klsmartin.com/typo3temp/assets/_processed_/f/b/csm_Implants_hand_Ixos_735x370_02_2bc1404e36.jpg



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Korosi



Korosi = proses elektrokimia, dimana ada: ▪



Anoda (logam), reaksi anodik (oksidasi): logam → ion logam+ + elektron



▪



Katoda (logam), reaksi katodik (reduksi):



air + oksigen + elektron → ion hidroksil ▪



Elektrolit: cairan tubuh, air, oksigen, inorganik, organik



▪



Aliran arus listrik dari anoda ke katoda melalui elektrolit



Faktor pendukung korosi: ▪ faktor fisik dan mekanik: pH, suhu, beban mekanik, gesekan, variasi logam, dsb. ▪ senyawa inorganik: ion khlor, sulfat, karbonat, dsb. ▪ senyawa organik: protein, enzim, bakteri, dsb. Gittens, et al. Electrical implications of corrosion for osseointegration of titanium implants. Journal of Dental Research 2011, 90, 1389. Photo: Fractography, https://www.fose1.plymouth.ac.uk/fatiguefracture/tutorials/FailureAnalysis/Images/Fractography/Cr_Plate_Cleavage.jpg



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Alergi, infeksi, dll.



Komplikasi yang dapat disebabkan oleh pemasangan implan: ▪ Infeksi ▪ Reaksi alergi ▪ “Stress shielding effect” Hermawan and Mahyudin. Biomaterials and Medical Devices: A Perspective from an Emerging Country. Springer, 2016. Photo: Dental implant X-ray illustration, https://obriendentallab.com/wp-content/uploads/2019/07/x-ray-illustration-implant-and-crown-cropped.jpg



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Quiz



Di antara kegagalan implan logam berikut, mana yang tidak diakibatkan oleh pembebanan mekanik? A. B. C. D.



Kelelahan Korosi Patah Keausan



Photo: Toronto landscape: https://i.pinimg.com/originals/b6/02/6c/b6026cf0af6a97b1d2fbdedff42eccf8.jpg



H. Hermawan



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Clinically driven material design (1) Perbedaan modulus Young (E): ▪ Tulang ~ 30 GPa



▪ Ti-6Al-4V ~ 110 GPa ▪ SS316L ~ 180 GPa ▪ Co-based alloy ~ 210 GPa E   stress shielding effect  bone absorption  implant loosening  bone fracture  Low modulus alloys Recent Ti alloys: ▪ High cost elements: Ti-13Nb-13Zr, Ti-12Mo-6Zr-2Fe (TMZF), Ti15Mo, Ti-16Nb-10Hf (Tiadyne 1610), Ti-15Mo-5Zr-3Al, Ti-35.3Nb5.1Ta-7.1Zr (TNZT) and Ti-29Nb-13Ta-4.6Zr (TNTZ) ▪ Low cost elements: Ti-10Cr-Al, Ti-Mn, Ti-Mn-Fe, Ti-Mn-Al, Ti-Cr-Al, Ti-Sn-Cr, Ti-Cr-Sn-Zr, Ti-(Cr,Mn)-Sn and Ti-12Cr ▪ E for -type = 40-80 GPa ▪ E for single crystal TNTZ 100 = 35 GPa



Metaphysis fracture of the femur with severe stress shielding Harumoto, et al. Cementless total hip replacement: past, present and future. J Ortho Sci 2009, 14, 228. Niinomi, et al. Development of new metallic alloys for biomedical applications. Acta Biomaterialia 2012, 8, 3888.



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Clinically driven material design (2)



H. Hermawan



Spinal fixation devices: ▪ preferably has low modulus (E) ▪ bending sometime is needed ▪ bending + low E  springback  self tunable modulus  E due to bending  Ti-Cr alloys



www.thespinemarketgroup.com



Niinomi, et al. Development of new metallic alloys for biomedical applications. Acta Biomaterialia 2012, 8, 3888.



www.bnasurg.com



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Clinically driven material design (3)



https://5.imimg.com/data5/LH/XO/MY-695170/bone-plate-500x500.jpg



Removable implants: ▪ assimilation with bone  refracture



▪ precipitation of Ca/P must be inhibited  Ti-Zr alloys



www.aofoundation.org



Niinomi, et al. Development of new metallic alloys for biomedical applications. Acta Biomaterialia 2012, 8, 3888.



H. Hermawan



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Clinically driven material design (4)



www.syntellix.de



Absorbable metal implant: ▪ assists bone fracture healing and degrades  No need for 2nd surgery, no stress shielding  Mg alloys



Hermawan, H. Updates on the research and development of absorbable metals for biomedical applications. Progress in Biomaterials 2018, 7, 93



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Quiz



Sifat material mana yang berhubungan dengan « stress shielding effect »? A. B. C. D.



Kekerasan (hardness) Kekuatan luluh (yield strength) Modulus Young Rapat massa (density)



Photo: Winter at Laval University: https://www.bve.ulaval.ca/en/international-students/photo-contest/winners/



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Pasar biomaterial Amerika Serikat saja mencapai miliaran dolar, Dunia = 2-3 kali pasar Amrik



Impor alat kesehatan Indonesia berdasarkan sektor paling potensial dalam jutaan dolar Amrik



Ratner BD. Elsevier Inc. 2004. Oxford; http://www.s-ge.com/sites/default/files/private_files/Marktstudie%20S-GE-Medical%20Devices%20in%20Indonesia_0.pdf



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Regulasi dan regulator Perbedaan sistem Amerika Serikat dan Uni Eropa US Regulatory System



EU Regulatory System



QSR - 21 CFR Part 820 Inspection by FDA



ISO 13485 (MDSAP) Assessment by Notified Body (depending on classification)



PMA (approval) or 510(k) (clearance)



Technical Documentation Sampled by Notified Body (depending on classification) • General Safety and Performance Requirements • Risk Assessment • Clinical Evaluation (taking account of equivalent devices)



Reviewed by FDA



Manufacturers Declaration of Conformity FDA US Market Clearance/Approval



CE Marking



MDR



Manufacturers Postmarket Surveillance (including complaints and vigilance)



FDA Inspections (24 months)



Regulatory bodies Europe: European Medicines Agency - European Commission (EC): http://ec.europa.eu/ USA: Food and drug Administration (FDA) http://www.fda.gov/ Canada: Health Canada http://www.hc-sc.gc.ca/ Japan: Pharmaceuticals and Medical Devices Agency of Japan (PMDA) http://www.pmda.go.jp/ China: State Food and Drug Administration (SFDA) http://www.sfda.com/



Notified Body QMS Audits (annually)



Australia: Therapeutics Goods Administration (TGA) https://www.tga.gov.au



Notified Body QMS/Device Recertification Every Five Years



Indonesia: Badan Pengawas Obat dan Makanan https://www.pom.go.id



Courtesy: A Purnama, regulatory affair officer



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Standard ASTM



ASTM International, known until 2001 as the American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards. http://www.astm.org/



Section 13 - Medical Devices and Services Volume 13.01, January 2005 Medical and Surgical Materials and Devices; Anesthetic and Respiratory Equipment; Pharmaceutical Application of Process Analytical Technology Photo: Bone fracture fixation plates and screws: https://i.pinimg.com/originals/f3/b1/85/f3b18562df9d94a25b10b9cb35f3acda.jpg



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Standard ISO ISO 10993 Medical devices testing standard ISO standard



Title



ISO 10993-1 ISO 10993-2 ISO 10993-3 ISO 10993-4 ISO 10993-5 ISO 10993-6 ISO 10993-7 ISO 10993-9 ISO 10993-10 ISO 10993-11 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-15 ISO 10993-16 ISO 10993-17 ISO 10993-18 ISO/TS* 10993-19 ISO /TS* 10993-20



Evaluation and testing Animal welfare requirements Tests for genotoxicity, carcinogenicity, and reproductive toxicity Selection of tests for interactions with blood Tests for in vitro toxicity Tests for local effects after implantation Ethylene oxide sterilization residuals Framework for identification and quantification of potential degradation products Tests for irritation and delayed-type hypersensitivity Tests for systemic toxicity Sample preparation and reference materials Identification and quantification of degradation products from polymeric devices Identification and quantification of degradation products from ceramic devices Identification and quantification of degradation products from metals and alloys Toxicokinetic study design for degradation products and leachables Establishment of allowable limits for leachable substances Chemical characterization of materials Physicochemical, morphological, and topographical characterization of materials Principles and methods for immunotoxicological testing of medical devices



*TS = Technical specification only, no ISO standard



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Hendra Hermawan adalah associate professor di Department of Mining, Metallurgical and Materials Engineering, Laval University, Kanada1. Tiga lisensi insinyur profesional pernah didapatnya: IPP (Persatuan Insinyur Indonesia), CEng (the Engineering Council, Inggris), dan PEng (the Association of Professional Engineers of Ontario*, Kanada). Sebelum bergabung dengan afiliasi yang sekarang di tahun 2014, beliau sempat menjadi dosen di Universiti Teknologi Malaysia and peneliti posdok industri di CHU de Québec Research Center. Diantara mata kuliah yang Dr. Hermawan ampu adalah Pemilihan material, Material komposit, dan Kesehatan dan keselamatan kerja. Penelitian beliau terfokus pada aspek metalurgi dan degradasi dari logam untuk aplikasi medikal yang kebanyakan didanai oleh lembaga hibah pemerintah. Beliau telah membimbing 25 mahasiswa pascasarjana dan menerbitkan lebih dari 100 artikel dan komunikasi ilmiah2.



Kuliah ini didedikasikan untuk guru saya almarhum Prof. Rochim Suratman, dosen pembimbing S1-S2, al-fatihah!



Dr. Hermawan melayani komunitas ilmiah dengan menjadi anggota dewan editor di Scientific Reports (Springer Nature), Journal of Orthopaedic Translation (Elsevier) dan Metals (MDPI), serta menjadi juri penilai untuk artikel-artikel yang berkaitan dengan ilmu dan teknologi material sebelum terbit di berbagai jurnal internasional3. Beliau juga terlibat dalam penjurian proposal riset untuk banyak lembaga hibah, termasuk Irish Research Council (Irlandia), Polish National Science Center (Polandia), Swiss National Science Foundation (Swiss), Wellcome Trust/DBT India (India), dan US-Israel Binational Science Foundation (Amerika Serikat). Beliau pernah menjadi juri untuk disertasi dari beberapa universitas, diantaranya Laurentian University (Kanada), Swinburne University of Technology (Australia), Universiti Malaysia Trengganu (Malaysia), Politecnico di Milano (Italia), dan University of Malta (Malta). Alamat kontak: [email protected] Referensi: 1. Homepage: https://www.fsg.ulaval.ca/departements/professeurs/hendra-hermawan-292 2. Publication record: https://www.scopus.com/authid/detail.uri?authorId=56500756700 3. Editorial record: https://publons.com/researcher/1188878/hendra-hermawan