Biomaterials The Intersection of Biology and Materials Science

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1 Biomaterials The Intersection of Biology and Materials Science J. S. Temenoff Wallace H. Coulter Department of Biomedical Engineering Georgia Tech and Emory University, Atlanta, GA A. G. Mikos Departments of Bioengineering and Chemical and Biomolecular Engineering Rice University, Houston, TX PEARSON Prentice Hall Upper Saddle River, New Jersey 07458

2 Contents Foreword xix Preface xxi Acknowledgments 1 xiii Materials for Biomedical Applications Introduction to Biomaterials Important Definitions History and Current Status of the Field Future Directions Biological Response to Biomaterials Biomaterial Product Testing and FDA Approval Types of Biomaterials Metals Ceramics Polymers Naturally Derived vs. Synthetic Polymers Processing of Biomaterials Important Properties of Biomaterials Degradative Properties of Biomaterials Surface Properties of Biomaterials Bulk Properties of Biomaterials Characterization Techniques Principles of Chemistry Atomic Structure Atomic Models Bohr Model Wave-Mechanical Model Atomic Orbitals Shapes of Subshells (Orbitals) Order of Subshells and the Aufbau Principle Valence Electrons and the Periodic Table Ionic Bonding Bonding and Force-Distance Curves Characteristics of the Ionic Bond Covalent Bonding Atomic Orbitals and Hybridization Molecular Orbitals Mixed Bonds Metallic Bonding Secondary Forces 28 Summary 28 Problems 29 References 30 Additional Reading 31

3 2 Chemical Structure of Biomaterials Introduction: Bonding and the Structure of Biomaterials Structure of Metals Crystal Structures Face-Centered Cubic Structure Body-Centered Cubic Structure Crystal Systems Defects in Crystal Structures Point Defects Impurities Solid State Diffusion Diffusion Mechanisms Modeling of Diffusion Structure of Ceramics Crystal Structures AX Crystal Structures A m X p Crystal Structures Carbon-Based Materials Defects in Crystal Structures Point Defects Impurities Structure of Polymers General Structure Repeat Units Molecular Weight Determination Mer Configuration Polymer Structure Polymer Synthesis Addition Polymerization Condensation Polymerization Polymer Production Via Genetic Engineering Copolymers Methods of Polymerization Crystal Structures and Defects Crystal Structures Point Defects and Impurities Techniques: Introduction to Material Characterization X-Ray Diffraction Basic Principles Instrumentation Information Provided Ultraviolet and Visible Light Spectroscopy (UV-VIS) Basic Principles Instrumentation Information Provided 78 *

4 Infrared Spectroscopy (IR) Basic Principles Instrumentation Information Provided Nuclear Magnetic Resonance Spectroscopy (NMR) Basic Principles Instrumentation Information Provided Mass Spectrometry Basic Principles Instrumentation Information Provided High-Performance Liquid Chromatography (HPLC): Size-Exclusion Chromatography Basic Principles Instrumentation Information Provided 93 Summary 95 Problems 96 References 99 Additional Reading 100 Physical Properties of Biomaterials Introduction: From Atomic Groupings to Bulk Materials Crystallinity and Linear Defects Dislocations Edge Dislocations Screw and Mixed Dislocations Characteristics of Dislocations Deformation Crystallinity and Planar Defects External Surface Grain Boundaries Crystallinity and Volume Defects Crystallinity and Polymerie Materials Percent Crystallinity Chain-Folded Model of Crystallinity Defects in Polymer Crystals Linear Defects Planar and Volume Defects Thermal Transitions of Crystalline and Non-Crystalline Materials ViscousFlow Thermal Transitions Metals and Crystalline Ceramics Amorphous Ceramics (Glasses) Polymers 120»

5 VIII Contents 3.7 Techniques: Introduction to Thermal Analysis Differential Scanning Calorimetry Basic Principles Instrumentation Information Provided 127 Summary 128 Problems 129 References 131 Additional Reading 132 Mechanical Properties of Biomaterials Introduction: Modes of Mechanical Testing Mechanical Testing Methods, Results and Calculations Tensile and Shear Properties Calculations for Tensile and Shear Tests Stress-Strain Curves and Elastic Deformation Molecular Causes of Elastic Deformation Stress-Strain Curves and Plastic Deformation Molecular Causes of Plastic Deformation Causes of Plastic Deformation Metals and Crystalline Ceramics Causes of Plastic Deformation Amorphous Polymers and Ceramics (Glasses) Causes of Plastic Deformation Polymers (General) Causes of Plastic Deformation Semi-Crystalline Polymers and Elastomers Bending Properties Time-Dependent Properties Creep Molecular Causes of Creep Metals Molecular Causes of Creep Ceramics Molecular Causes of Creep Polymers Stress Relaxation and its Causes Mathematical Models of Viscoelastic Behavior Viscoelastic Behavior Maxwell Model Viscoelastic Behavior Voigt Model Influence of Porosity and Degradation on Mechanical Properties Fracture and Failure Ductile and Brittle Fracture Polymer Crazing Stress Concentrators Fatigue and Fatigue Testing Fatigue Fatigue Testing Factors that Affect Fatigue Life Methods to Improve Mechanical Properties Techniques: Introduction to Mechanical Analysis Mechanical Testing Basic Principles 171

6 Instrumentation Information Provided 172 Summary 172 Problems 174 References 176 Additional Reading 176 Biomaterial Degradation Introduction: Degradation in the Biological Environment Corrosion/Degradation of Metals and Ceramics Fundamentals of Corrosion Oxidation-Reduction Reactions Half-Cell Potentials Nernst Equation Galvanic Corrosion Pourbaix Diagrams and Passivation Contribution of Processing Parameters Crevice Corrosion Pitting Corrosion Intergranular Corrosion Contribution of the Mechanical Environment Stress and Galvanic Corrosion Stress Corrosion Cracking Fatigue Corrosion Fretting Corrosion Contribution of the Biological Environment Means of Corrosion Control Ceramic Degradation Degradation of Polymers Primary Means of Polymer Degradation Chain Scission by Hydrolysis Chain Scission by Oxidation Other Means of Degradation Environmental Stress Cracking Enzyme-Catalyzed Degradation Effects of Porosity Biodegradable Materials Biodegradable Ceramics Erosion Mechanisms Factors that Influence Degradation Rate Biodegradable Polymers Introduction to Biodegradable Polymers and Definitions Degradation Mechanisms Factors that Influence Degradation Rate 198 «

7 X Contents 5.5 Techniques: Assays for Extent of Degradation 199 Summary 200 Problems 201 References 203 Additional Reading Biomaterial Processing Introduction: Importance of Biomaterials Processing Processing to Improve Bulk Properties Metals Alloying Strain Hardening Grain Size Refinement Annealing Precipitation Hardening Ceramics Polymers Processing to Form Desired Shapes Processing of Metals Forming Operations Forging Metals Rolling Metals Extrusion of Metals Drawing Metals Casting Metals Sand Casting of Metals Investment Casting of Metals Powder Processing of Metals Rapid Manufacturing of Metals Welding Metals Machining of Metals Processing of Ceramics Glass Forming Techniques Casting and Firing of Ceramics Casting Ceramics Firing Ceramics Powder Processing of Ceramics Rapid Manufacturing of Ceramics Processing of Polymers Thermoplasts vs. Thermosets Forming Polymers Extrusion of Polymers Fiber Spinning of Polymers Casting Polymers Compression Molding of Polymers Injection Molding of Polymers Blow Molding of Polymers 221

8 6.6.4 Rapid Manufacturing of Polymers Processing to Improve Biocompatibility Sterilization Steam Sterilization Ethylene Oxide Sterilization Radiation Sterilization Fixation of Natural Materials 224 Summary 225 Problems 226 References 226 Additional Reading Surface Properties of Biomaterials Introduction: Concepts in Surface Chemistry and Biology Protein Adsorption and Biocompatibility Surface Properties Governing Protein Adsorption Physicochemical Surface Modification Techniques Introduction to Surface Modification Techniques Physicochemical Surface Coatings: Covalent Surface Coatings Plasma Treatment Chemical Vapor Deposition Physical Vapor Deposition Radiation Grafting/Photografting Self-Assembled Monolayers Physicochemical Surface Coatings: Non-Covalent Surface Coatings Solution Coatings Langmuir-Blodgett Films Surface-Modifying Additives Physicochemical Surface Modification Methods with No Overcoat Ion Beam Implantation Plasma Treatment Conversion Coatings Bioactive Glasses Laser Methods for Surface Modification Biological Surface Modification Techniques Covalent Biological Coatings Non-Covalent Biological Coatings Immobilized Enzymes Surface Properties and Degradation Patterning Techniques for Surfaces Techniques: Introduction to Surface Characterization Contact Angle Analysis Basic Principles Instrumentation Information Provided 253

9 7.6.2 Light Microscopy Basic Principles Instrumentation Information Provided Electron Spectroscopy for Chemical Analysis (ESCA) or X-ray Photoelectron Spectroscopy (XPS) Basic Principles Instrumentation Information Provided Attenuated Total Internal Reflectance Fourier Transform Infrared Spectroscopy (ATR-FTIR) Basic Principles Instrumentation Information Provided Secondary Ion Mass Spectrometry (SIMS) Basic Principles Instrumentation Information Provided Electron Microscopy: Transmission Electron Microscopy (TEM) and Scanning Electron Microscopy (SEM) Basic Principles Instrumentation Information Provided Scanning Probe Microscopy (SPM): Atomic Force Microscopy (AFM) Basic Principles Instrumentation Information Provided 269 Summary 272 Problems 273 References 276 Additional Reading 277» 8 Protein Interactions with Biomaterials Introduction: Thermodynamics of Protein Adsorption Gibbs Free Energy and Protein Adsorption System Properties Governing Protein Adsorption Protein Structure Amino Acid Chemistry Primary Structure Secondary Structure Tertiary Structure Quaternary Structure Protein Transport and Adsorption Kinetics Transport to the Surface Adsorption Kinetics Reversibility of Protein Adsorption Reversible and Irreversible Binding Desorption and Exchange 297

10 Contents XÜi 8.5 Techniques: Assays for Protein Type and Amount High-Performance Liquid Chromatography (HPLC): Affinity Chromatography Basic Principles Instrumentation Information Provided Colorimetric Assays Basic Principles and Instrumentation Fluorescent Assays Basic Principles Instrumentation Information Provided Enzyme-linked Immunosorbent Assay (ELISA) Basic Principles and Procedures Western Blotting Basic Principles and Procedures 309 Summary 310 Problems 311 References 312 Additional Reading Cell Interactions with Biomaterials Introduction: Cell-Surface Interactions and Cellular Functions Cellular Structure Cell Membrane Cytoskeleton Mitochondria Nucleus Structure and Function of the Nucleus Structure of DNA Structure of RNA Endoplasmic Reticulum Vesicles Membrane Receptors and Cell Contacts Types of Cell Contacts Types of Membrane Receptors and Ligands Extracellular Environment Collagen Elastin Proteoglycans Glycoproteins Other ECM Components Matrix Remodeling ECM Molecules as Biomaterials Cell-Environment Interactions that Affect Cellular Functions Cell Survival Cell Proliferation Cell Cycle: Interphase Cell Cycle: Mitosis 337

11 xiv Contents Cell Differentiation Protein Synthesis Collagen Synthesis: Transcription Collagen Synthesis: Translation and Post-Translational Modification Models of Adhesion, Spreading and Migration Basic Adhesion Models: DLVO Theory DLVO Theory Limitations and Further Models Models of Cell Spreading and Migration Cell Spreading Cell Migration Techniques: Assays to Determine Effects of Cell-Material Interactions Cytotoxicity Assays Direct Contact Assay Agar Diffusion Assay Elution Assay Adhesion/Spreading Assays Migration Assays DNA and RNA Assays Polymerase Chain Reaction (PCR) and Reverse- Transcription Polymerase Chain Reaction (RT-PCR) Southern and Northern Blotting Protein Production Assays: Immunostaining 361 Summary 362 Problems 364 References 366 Additional Reading Biomaterial Implantation and Acute Inflammation Introduction: Overview of Innate and Acquired Immunity Characteristics of Leukocytes Leukocyte Types Leukocyte Formation Life Span of Leukocytes Sources of Innate Immunity Clinical Signs of Inflammation and Their Causes Role of Tissue Macrophages and Neutrophils Migration of Neutrophils Actions of Neutrophils Phagocytosis Respiratory Burst Secretion of Chemical Mediators Role of Other Leukocytes Monocytes/Macrophages Actions of Macrophages Phagocytosis and Biomaterials Secretion of Chemical Mediators Role as Antigen-Presenting Cells Other Granulocytes 378

12 10.5 Termination of Acute Inflammation Techniques: In Vitro Assays for Inflammatory Response Leukocyte Assays Other Assays 382 Summary 382 Problems 383 References 384 Additional Reading Wound Healing and the Presence of Biomaterials Introduction: Formation of Granulation Tissue Foreign Body Reaction Fibrous Encapsulation Chronic Inflammation Four Types of Resolution Repair vs. Regeneration: Wound Healing in Skin Skin Repair Skin Regeneration Techniques: In Vivo Assays for Inflammatory Response Considerations in Development of Animal Models Choice of Animal Choice of Implant Site Length of Study Biomaterial Considerations: Dose and Administration Inclusion of Proper Controls Methods of Assessment Histology/Immunohistochemistry Electron Microscopy Biochemical Assays Mechanical Testing 398 Summary 399 Problems 399 References 401 Additional Reading Immune Response to Biomaterials Introduction: Overview of Acquired Immunity Antigen Presentation and Lymphocyte Maturation Major Histocompatibility Complex (MHC) Molecules MHC Class I MHC Class II MHC Molecule Variation and Tissue Typing Intracellular Complexation with MHC Molecules Maturation of Lymphocytes Activation and Formation of Clonal Populations 408

13 Xvi Contents 12.3 B Cells and Antibodies Types of B Cells Characteristics of Antibodies Structure of Antibodies Classes of Antibodies Mechanisms of Antibody Action T Cells Types of T Cells Helper T Cells (T h ) Cytotoxic T Cells (T c ) The Complement System Classical Pathway Alternative Pathway Membrane Attack Complex Regulation of the Complement System Effects of the Complement System Undesired Immune Responses to Biomaterials Innate vs. Acquired Responses to Biomaterials Hypersensitivity Type I: IgE Mediated Type II: Antibody Mediated Type III: Immune Complex Mediated Type IV: T Cell Mediated Hypersensitivity and the Classes of Biomaterials Techniques: Assays for Immune Response In Vitro Assays In Vivo Assays 423 Summary 424 Problems 426 References 426 Additional Reading Biomaterials and Thrombosis Introduction: Overview of Hemostasis Role of Platelets Platelet Characteristics and Functions Platelet Activation Means of Activation Sequelae of Activation Coagulation Cascade Intrinsic Pathway Extrinsic Pathway Common Pathway Means of Limiting Clot Formation Role of the Endothelium Tests for Hemocompatibility 436

14 General Testing Concerns In Vitro Assessment In Vivo Assessment 438 Summary 439 Problems 440 References 442 Additional Reading 442 Infection, Tumorigenesis and Calcification of Biomaterials Introduction: Overview of Other Potential Problems with Biomaterial Implantation Infection Common Pathogens and Categories of Infection Steps to Infection Characteristics of the Bacterial Surface, the Biomaterial Surface, and the Media Bacterial Surface Properties: Gram-Positive vs. Gram-Negative Bacteria Bacterial Surface Properties: Cell Capsule and Biofilm Biomaterial Surface Properties Media Properties Specific and Non-Specific Interactions Involved in Bacterial Adhesion Summary of Implant-Associated Infections Techniques for Infection Experiments Characterizing Bacterial Surfaces Surface Hydrophobicity Surface Charge In Vitro and In Vivo Models of Infection In Vitro Bacterial Adhesion Ex Vivo and In Vivo Infection Models Tumorigenesis Definitions and Steps of Tumorigenesis Chemical vs. Foreign Body Carcinogenesis Timeline for Foreign Body Tumorigenesis Foreign Body Tumorigenesis with Large Implants Foreign Body Tumorigenesis with Small Fibers Summary of Biomaterial-Related Tumorigenesis Techniques for Tumorigenesis Experiments In Vitro Models In Vivo Models Pathologie Calcification Introduction to Pathologie Calcification Mechanism of Pathologie Calcification Summary and Techniques to Reduce Pathologie Calcification 460

15 14.7 Techniques for Pathologie Calcification Experiments In Vitro Models of Calcification In Vivo Models of Calcification Sample Assessment 461 Summary 463 Problems 465 References 466 Additional Reading 466 Appendix I: List of Abbreviations and Symbols 468 Index 471

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