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BIOMATERIALS in Medicine

BIOMATERIALS in Medicine. Titik Nuryastuti MIcrobiology Department, Fac. of Medicine Universitas Gadjah Mada. INTRODUCTION. A biomaterial is a nonviable material used in a medical device, intended to interact with biological systems.

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BIOMATERIALS in Medicine

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  1. BIOMATERIALSin Medicine Titik Nuryastuti MIcrobiology Department, Fac. of Medicine Universitas Gadjah Mada

  2. INTRODUCTION A biomaterial is a nonviable material used in a medical device, intended to interact with biological systems. is used to make devices to replace a part of a function of the body in a safe, reliable, economic, and physiologically acceptable manner. is any substance (other than a drug), natural or synthetic, that treats, augments, or replaces any tissue, organ, and body function. The need for biomaterials stems from an inability to treat many diseases, injuries and conditions with other therapies or procedures : replacement of body part that has lost function (total hip, heart) correct abnormalities (spinal rod) improve function (pacemaker, stent) assist in healing (structural, pharmaceutical effects: sutures, drug release)

  3. HISTORY Important dates 1860's: Lister develops aseptic surgical technique early 1900's: Bone plates used to fix fractures 1930's: Introduction of stainless steel, cobalt chromium alloys 1938 : first total hip prosthesis (P. Wiles) 1940's: Polymers in medicine: PMMA bone repair; cellulose for dialysis; nylon sutures 1952: Mechanical heart valve 1953: Dacron (polymer fiber) vascular grafts 1958: Cemented (PMMA) joint replacement 1960: first commercial heart valves 1970's: PEO (polyethyleneoxide) protein resistant thin film coating 1976: FDA ammendment governing testing & production of biomaterials /devices 1976: Artificial heart (W. Kolff)

  4. EXAMPLES OF USES OF BIOMATERIALS B. Amsden CHEE 340

  5. MATERIAL ATTRIBUTES FOR BIOMEDICAL APPLICATIONS

  6. BIOCOMPATIBILITY There is no general set of criteria, that if met, qualify a material as being biocompatible The time scale over which the host is exposed to the material or device must be considered

  7. Classes of Biomaterials Metals stainless steel, cobalt alloys, titanium alloys Ceramics aluminum oxide, zirconia, calcium phosphates Polymers silicones, poly(ethylene), poly(vinyl chloride), polyurethanes, polylactides Natural polymers collagen, gelatin, elastin, silk, polysaccharides

  8. Material Properties OBJECTIVES To introduce the fundamental mechanical and surface chemistry properties of biomaterials OUTLINE Mechanical Properties elasticity, viscoelasticity, brittle fracture, fatigue Surface chemistry

  9. Mechanical Properties Many applications require the biomaterial to assume some of the applied load on the body part. tension shear

  10. Viscoelasticity The response of materials to an imposed stress may under certain conditions resemble the behavior of a solid or a liquid. Stress Relaxation (application of a sudden strain to the sample and following the stress as a function of time as the strain is held constant). • Creep (a constant stress is instantaneously applied to the material and the resulting strain is followed as a function of time)

  11. Surface Energy Interface boundary between 2 layers significance protein adsorption to materials blood coagulation/thrombosis due to material contact cellular response to materials

  12. Surface Chemistry At the surface (interface) there are intermolecular forces and intramolecular forces of attraction and repulsion. van der Waals forces : Hydrogen Bonds : Coulombic : B. Amsden CHEE 340

  13. Surface Electrical Properties surface may become charged by adsorption of ionic species present in sol’n or preferential adsorption of OH- ionization of -COOH or -NH2 group + - + - + - + - + - + hydroxyl ion - solid

  14. Surface Energy and the Contact Angle gLV q gSV gSL

  15. Bacterial Adhesion to Biomaterials 12/20/2019 15

  16. Definition: Biomaterial Any material of natural or of synthetic origin that comes in contact with tissue, blood or biological fluids, and intended for use in prosthetic, diagnostic, therapeutic or storage applications without adversely affecting the living organism and its components. 12/20/2019 16

  17. Applications of Biomaterials Orthopedics: artificial hips,knees, shoulders, wrists; intervertebral discs; fracture fixation; bone grafts. Cardiovascular: heart valves, PTCA balloons, pacemakers, catheters, grafts, stents. Dental: enamels, fillings,prosthetics, orthodontics. Soft tissue: wound healing, reconstructive and augmentation, occular. Surgical: staples, sutures, scalpels.

  18. Orthopedic Implants

  19. Cardiovascular devices

  20. Therapeutic Devicesin Orthopedics 12/20/2019 20

  21. Applications in Dentistry 12/20/2019 21

  22. Catheters 12/20/2019 22

  23. In Ophthalomolgy 12/20/2019 23

  24. In Nephrology 12/20/2019 24

  25. In Drug Delivery 12/20/2019 25

  26. Future Applications-Tissue Replacement 12/20/2019 26

  27. General Applications of Biomaterials Storage of fluids, tissues, and other biological products Diagnosis Monitoring Therapy 12/20/2019 27

  28. Definition: Biomaterial -FDA "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals." 12/20/2019 28

  29. Classification of Medical Devices Based on the duration of the device use, invasiveness and risk to the user. Class I devices: crutches, bedpans, tongue depressors, adhesive bandages etc. –minimal invasiveness, does not contact the user internally. Class II devices: hearing aids, blood pumps, catheters, contact lens, electrodes etc. –higher degree of invasiveness and risk, but relatively short duration. Class III devices: cardiac pacemakers, intrauterine devices, intraocular lenses, heart valves, orthopedic implants, etc. -considerably more invasive and can pose immense risk to the user-implantables. 12/20/2019 29

  30. Biocompatibility testing include procedures designed to evaluate: cytotoxicity; acute, subchronic, and chronic toxicity; irritation to skin, eyes, and mucosal surfaces; sensitization; hemocompatibility; short-term implantation effects; genotoxicity; carcinogenicity; and effects on reproduction, including developmental effects. 12/20/2019 30

  31. Thank you

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