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When Does a Material Become a Biomaterial?

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When Does a Material Become a Biomaterial? When does a material become a biomaterial? Prof. Dr. Ir. Jan Van Humbeeck MTM-K.U.Leuven 1 When it is allowed making contact with human tissue 2 The goal of using biomaterials: Assisting in • Regenerating • Repairing • Supporting • Replacing defect tissues and esthetic parts. 3 Origin of defects in the body • Life quality: – congenital defects – development defects – diseases – accidents – aesthetic reasons • Tissue degeneration due to aging: – Osteoporosis – Hart failure – Wear of joints 4 A problem of aging Czech expression: If you’re over 60 and wake up one morning and nothing hurts, then you’re probably dead. 5 What is a biomaterial? • A biomaterial is a nonviable material used in a (medical) device, intended to interact with biological systems (biofunctionality). (Williams, 1987) • A biomaterial is a material intended to interface with biological systems to evaluate, treat, augment or replace any tissue, organ or function of the body. • A biomaterial is a material that should perform an intended function over a definite amount of time in a specific biological environment, as good as possible. • Biomaterials are inorganic or organic materials that are biocompatible and can be implanted in the human body to replace or repair failing tissue. 6 History of biomaterials • 1° generation-materials: based on replacing tissue or replacing a function with as low as possible interaction with the surrounding tissue. Those materials were found in the classic industrial markets. Those materials were selected because of their corrosion resistance or inertness when in contact with a tissue. • metals: SS, Ti, Co-Cr • polymers: UHMWPE, PMMA, PMDS • ceramics: Al2O3 7 Did Georg Washingthon A false toe made of out of wood and leather had a wooden set of teeth? was found on a 3,000-year-old mummified body of an Egyptian noblewoman Cripple with supporting pole. Italian vase, 4 BC. The Louvre. Teeth were extracted from the dead to make dentures, so many got collected after battles, and in her time known as Waterloo Teeth. The desperately poor also sold their teeth. Real teeth were considered the best replacement for people who had lost their own. (19th century) 8 • 2° generation-materials: one searches for and develops specific biomaterials that can be bioactive and stimulate tissue repair or tissue growth. – metals: SMA, new beta-Ti alloys, porous materials – polymers: biodegradable – ceramics: bioactive glass, hydroxyapatiet 9 • 3° generation-materials: tissue engineering. - Regenerative biomaterials in combination with living cells - Biological active materials - Transformation in and formation of new tissue (i.e. osteoinductive material). 10 Different kinds of biomaterialen I. Inorganic biomaterials • Bio-tolerated materials: reactions between tissue and material are possible but should not be harmful (i.e. Incapsulation) • Bio-inactive or bio-inert materials: do not show reaction with the tissue • Bio-active materials should stimulate tissue repair and/or growth II. Organic biomaterials: • Collagen, (demineralised ) bone, hart valves from pigs, transplants (auto-, allo-, xenograften) • polymers III. Combinations of inorganic en organic biomaterials 11 The classes of materials • Metals • Ceramics • Inorganic glasses • Polymers • Composites • Natural biomaterials 12 13 Metals • Metallic bounding in lattice structures • High E-modulus • Good strength • Good ductility (plasticity) • Few metals are biocompatible (non-toxic) 14 Ceramics • Anorganic components (oxides, nitrides, carbides, ..) with a combination of ionic and covalent binding • Complex crystal lattice or amorphous • (Generally) High E-modulus • Brittle especially under tensile loading • (relative) inert or very biodegradable 15 Inorganic glass • Closepacked but disordered structure • Often network structures (silicates, phosphates, bio-active glass, ..) 16 Polymers • Chain structures with covalent bindings (especially C) • Van der Waals and H-bridges between the chains • Amorphous or semi-crystalline • Low E-modulus • Enormous variability also within each class 17 Composites • Combination of two or more materials from the preceding families • Properties can be adapted by appropriate volume fractions and distribution of the different materials 18 Natural biomaterials • Proteins: – Silk – Collagen – Keratin – … • Polysaccharide: – Cellulose (cotton, wood)) – Chitin – Chitosan – … • Auto-, Allo-, Xenografts – Species dependent – Tissue dependent 19 The biological environment • At one hand side: the biological environment is very aggressive : high chemical activity with large variation in combination with a large spectrum of mechanical forces • At the other hand side: the biological environment is very constant concerning physical conditions and the composition of the environment as a consequence of a complex control system 20 The biological environment Consequence: Inflammation or infection The local reaction of a tissue due to a harmful stimulus : the stimulus can be physical, chemical or immunological (foreign body reaction) or can be a consequence of the presence of micro-organisms (bacteria's, viruses, parasites, …) Solution: - usage of bio-inert materials - within a timeframe usage of medicine to avoid (limit) inflammation or infection - sterilisation of the implant - medication attached to the implant (i.e. DES: Drug Eluting Stent) - usage of antibiotics 21 Table 22 Data related to essential trace elements Disorders of Essential metal metabolism in humans Selected Biochemical Distribution in various Element Requirement mg/day function body parts Element Deficiency Disorders Cobalt (Co) 0.14-1.77 Methionine metabolism Myocardium and bones Cardiomyopathy Cobalt (Co) Anemia, B12 deficiency Goiter Binding of insulin to cells, Lungs, liver, Carbohydrate Impairment of glucose Renal failure Chromium (Cr) 0.005-0.2 glucose metabolism lipid metabolism Chromium (Cr) tolerance Pulmonary cancer Blood, bone, brain, muscles, Hemoglobin synthesis, bone Anemia, growth retardation, Hepatitis, Cirrhosis, Copper (Cu) 2-6 skin, liver, intestine and development Copper (Cu) kidney changes in aortic elastin Tremor Iron (Fe) 8-18 Oxygen transport Liver, spleen and blood Hepatic failure Iron (Fe) Anemia Diabetes Arthritis Tissues, brain, endocrine Lithium (Li) 0.06-0.07 Pharmacological action and exocrine glands Lithium (Li) Manic depressive disorders Unknown Activator for enzymes, Bones, soft tissues, blood, Magnesium (Mg) 200-400 Physical stability of DNA chromosomes, Ribosomes Hallucination, Magnesium (Mg) Renal failure, Alcoholism Depression, Spasmophilia Oxidative phosphorylation, Mitochondria, liver, kidney, Manganese (Mn) 0.5-5 Cholesterol metabolism pancreas Manganese (Mn) Bleeding disorder Parkinson like syndrome Molybdenum (Mo) Esophageal cancer Hyperuricemia Dental enamel, bones, Molybdenum (Mo) 0.048-0.1 Xanthine metabolism intestine, liver and kidney Growth retardation, Gastric ulcer, Zinc (Zn) Psychological disturbances, Nucleic acid and protein Liver, prostrate, voluntary Respiratory distress Zinc (Zn) 8-15 synthesis muscles Gonad atrophy 23 Data related to toxic elements Distribution in various body Diseases caused by Excess Element Tolerance levels (µg/day) parts amounts Nausea, Vomiting, Diarrhea, Pigmentation of fingers and nails, Arsenic (As) 40-70 Skin, Hair, Tissues, Nail Burning of mouth and throat, Prostration and weakness Hyperglycemia, Skin cancer, Lungs, Liver, Carbohydrate and Chromium (Cr)+6 5-200 Lung cancer, Impair growth, Lipid metabolism Hypocholestremia Tremor, Diarrhea, Myocardial Mercury (Hg) 10-20 Kidney, Skin, Hair, nail necrosis, Fetotoxicity, Proteinuria Nausea, Vomiting, Diarrhea, Antimony (Sb) 9-11.3 Tissues Weakness Loss of hair, Lassitude, Selenium (Se) 130-200 Liver, Skin, Muscle, Kidney Depression, Dermatitis, Alcopia tumor Sterility, Neonatal mortality and Red blood cells, Liver, Kidney, Lead (Pb) 20-280 morbidity, Kidney damage, Skeleton Effects nervous system Kidney damage, Skeletal Cadmium (Cd) 10-50 Mollusks, Kidney, Tissues damage, Pulmonary damage 24 Requirements of a biomaterial 1. Biocompatibility: Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application (Williams, 1987) It refers in fact to the aspects concerning the absence of toxicity, immunogenicity, carcinogenicity and thrombogenicity 2. Biofunctionality: Simulating the function as good as possible . Load bearing (mechanical, physical, chemical) . Articulating (low wear and few wear debris) . Keeping the blood running . Filling the volumes . Creating electrical stimuli . Stimulation of the regeneration of tissue, …. Sterilizable, storable and resorbable 25 3. Mechanocompatibility: The stress on an implant should be preferably in the same order as the stress exerted on the environmental tissue to avoid the problem of “stress shielding”. 4. Biostability: A biomaterial will be either permanent either temporally either biodegradable. 5. Reliability, reproducibility or individually adapted. 26 Factors playing a role in biocompatibility • Problem: – Difference between tissue (living) and the material (dead) – The material of the implant in contact with the tissue creates a “foreign body reaction” 27 Factors playing a role in biocompatibility 28 Factors playing a role in biocompatibility Procedural definition: ISO 10993-1 “ A system or material that is in accordance with the following requirements is considered biocompatible” (tested according FDA of CE-norms). •Satisfy the conditions of animal welfare •testing genotoxicity, carcenogenicity
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