6/4/2010 Biomaterials in Medical device design 1 Dr J o sep h B u h a g ia r B.Eng (Hons.) PhD (Bham) Department of Metallurgy and Materials Engineering University of Malta Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra What is a biomaterial? 2 A biomaterial is a nonviable material used in a medical device intended to interact with biological systems (Williams, 1987) Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 1 6/4/2010 What is a biomaterial? 3 “medical” removed from definition: growing cells in culture processing biomolecules for biotechnology diagnostic gene arrays aquaculture of oysters Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra What is a biomaterial? 4 “nonviable” removed from definition: tissue engineering hybrid artificial organ applications living cells that are used as materials Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 2 6/4/2010 What is a biocompatibility? 5 “Biocompatibility” is the ability of a material to perform with an appropriate host response in a specific application (Williams, 1987) Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra What is a biocompatibility? 6 “host response”: resistance to blood clotting resistance to bacterial colonization normal (uncomplicated) healing Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 3 6/4/2010 What is a biocompatibility? 7 “specific application”: haemodialysis membrane (blood 3hrs) urinary catheter (inserted for a week) hip-joint replacement (life of a patient) Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Biomaterial performance requirements 8 Performance requirements : mechanical performance mechanical durability physical properties biocompatibility Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 4 6/4/2010 Biomaterial a multidisciplinary endeavour 9 Medicine Biology REQUIREMENTS Chemistry Manufacturing Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Family of biomaterials 10 Ceramic Al2O3 ZrO2, TiO2 Composite Metallic Polymeric Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 5 6/4/2010 Metallic biomaterials 11 Titanium Alloys Shape Memory Alloys Cobalt- Chromium Austenitic Stainless Steels Zirconium Alloys Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Ceramic biomaterials 12 Alumina (Al2O3) Zirconia (ZrO2) Calcium Phosphate Hydroxyapatite (HA) Bioactive Glasses Glass-Ceramics Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 6 6/4/2010 Ceramic biomaterials 13 Toxic surrounding material dies Nontoxic and biologically inactive (inert) fibrous tissue of variable thickness forms Nontoxic and biologically active (bioactive) interfacial bond forms Nontoxic and dissolves surrounding tissue replaces it Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Polymeric biomaterials 14 Ultra High Molecular Weight Polyethylene (UHMWPE) Polymethyl-methacrylate (PMMA) Silicone Biomaterials Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 7 6/4/2010 Nanotechnology in biomaterials 15 Silver Antimicrobial protection Biotextiles and dressings Handles in hospitals Medical devices Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Degradation of biomaterials 16 Pitting and crevice corrosion Fretting and corrosion-wear Fatigue Deformation Release of toxic elements Nickel Chromium (VI) Cobalt Vanadium Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 8 6/4/2010 Surface engineering of biomaterials 17 Coat or alloy the surface for: hardness corrosion-wear resistance fatigue resistance corrosion properties biocompatibility osseointegration hydrophilicity antibacterial properties Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Research in biomaterials (DMME) 18 Surface engineering of biomaterials Medical grade austenitic stainless steels Ni-Ti Shape memory alloys Development of dental biomaterials Dental cement in collaboration with Dr. J Camilleri Degradation evaluation of biomaterials Crevice Corrosion Pitting Corrosion Fretting-wear Corrosion-wear Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 9 6/4/2010 Collaboration interests (DMME) 19 Biocompatibility In-vitro and in-vivo testing Wet chemical analysis Ni and Cr content in solution Clinical studies Analysis of implant retrieval Design and manufacturing Prototypes manufacture and mechanical testing Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Surface nano analysis and characterisation 20 Low Energy Electron Diffraction Scanning Electron Microscope Secondary Ion Mass Spectroscopy X-Ray Photoelectron Spectroscopy Auger Electron Spectroscopy Scanning Tunnelling Microscope Atomic Force Microscope Time of Flight Funding ERDF: Setting up a material testing & rapid prototyping R&D facility Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 10 6/4/2010 Confocal laser scanning microscope 21 Biological Samples High Resolution Image Requisition True Spectral imaging 32 Channels of fluorescence Gentle on living cells Funding ERDF: Setting up a material testing & rapid prototyping R&D facility Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Scanning Electron Microscope (SEM) 22 Field Emission Energy Dispersive Spectroscopy (EDS) Wave Dispersive Spectroscopy (WDS) Electron Backscattering Diffraction (EBSD) Funding ERDF: Setting up a material testing & rapid prototyping R&D facility Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 11 6/4/2010 Nano-indentation and hardness 23 Nano Indentation: Hardness Testing of thin films Hot stage Cold Stage (-30°C) Liquid Cell Impact testing Scratch testing Other hardness testing: Macro-hardness Vickers micro-hardness Shore hardness Funding ERDF: Setting up a material testing & rapid prototyping R&D facility Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra X-Ray Diffraction 24 Phase determination Stress Analysis Thin film analysis Hot Stage Funding ERDF: • Setting up a material testing & rapid prototyping R&D facility • 4th Italian Protocol Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra 12 6/4/2010 Mechanical and corrosion testing 25 Tensile Tester Compression Tester Rotary Fatigue Tester Tribometer (pin-on-disc) Impact tester Potentiostat (corrosion) Salt spray cabinet Funding ERDF: • Setting up a material testing & rapid prototyping R&D facility • 4th Italian Protocol Biomedical Device Design & Manufacture in Malta - 1st June 2010, Dolmen, Qawra Email: [email protected] Tel: 2340 2439 Room: 107: Engineering Building Biomedical Device Design & Manufacture 26in Malta - 1st June 2010, Dolmen, Qawra 13
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