BIOLOGICAL PERFORMANCE of MATERIALS

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1 FOURTH EDITION BIOLOGICAL PERFORMANCE of MATERIALS Fundamentals of Biocompatibility Jonathan Black QfP) Taylor &. Francis >^ J Taylor & Francis Group Boca Raton London New York A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc.

Contents Part I General Considerations Chapter 1 Biocompatibility: Definitions and Issues 3 1.1 Introduction 3 1.2 Biological Performance 5 1.3 Consensus Definitions 6 1.4 Discussion 7 1.

2 Contents Part I General Considerations Chapter 1 Biocompatibility: Definitions and Issues Introduction Biological Performance Consensus Definitions Discussion The Discipline of Biomaterials Afterword: Paradigmatic Shift 12 References 14 Bibliography 15 Chapter 2 Introduction to the Biological Environment General Considerations Comparison of External and Internal Conditions Problems in Definition of the Biological Environment Elements of the Biological Environment Implant Life History Preimplantation Handling Effects 28 References 29 Bibliography 30 Part II Material Response: Function and Degradation of Materials In Vivo Chapter 3 Swelling and Leaching Introduction Fick's Laws of Diffusion Absorption Examples of Undesirable Absorption Osmotic Equilibrium Leaching Example of Planned Leaching: Drug Release Effects of Swelling and Leaching 46 References 46 Bibliography 47

Chapter 4 Corrosion and Dissolution 49 4.1 Chemistry of Corrosion 49 4.2 Classification of Reactions 50 4.3 The Pourbaix Diagram 51 4.4 The Electrochemical Series 54 4.5 Corrosion Rate 56 4.

3 Chapter 4 Corrosion and Dissolution Chemistry of Corrosion Classification of Reactions The Pourbaix Diagram The Electrochemical Series Corrosion Rate Potential-Current Relationships in Corrosion Forms of Corrosion Corrosion in Implant Applications Engineering Variables Affecting Corrosion Rates Corrosion Factors Peculiar to Biological Environments Ceramic Dissolution Polymer Dissolution Final Remarks '. 70 References 70 Bibliography 71 Chapter 5 Reactions of Biological Molecules with Biomaterial Surfaces Introduction Denaturation Organometallic Compounds Mechanical Aspects of Interfaces Results of Interfacial Adhesion of Molecules Effects of Charged Interfaces and Ions Final Comments 83 References 84 Bibliography 84 Chapter 6 Mechanics of Materials: Deformation and Failure Introduction Mechanics of Materials Elastic Modulus Yield Strength Fracture Strength Final Comment 104 References 104 Bibliography 105 Chapter 7 Friction and Wear Introduction Friction Lubrication 109

7.4 Wear 114 7.5 Conclusions 122 References t 122 Bibliography 123 Interpart 1 Implant Materials: Properties 125 11.1 Introduction 125 11.2 Metals 126 11.3 Polymers 129 11.4 Ceramics 131 11.

4 7.4 Wear Conclusions 122 References t 122 Bibliography 123 Interpart 1 Implant Materials: Properties Introduction Metals Polymers Ceramics Composites 132 References 134 Bibliography 135 Part III Host Response: Biological Effects of Implants Chapter 8 The Inflammatory Process Introduction The Inflammatory Response Infection Effects of Implant Degradation Products A Final Comment 160 References 160 Bibliography 162 Chapter 9 Coagulation and Hemolysis Introduction The Coagulation Cascade Approaches to Thromboresistant Materials Development Hemolysis Final Comments 179 References 180 Bibliography 181 Chapter 10 Adaptation Introduction Tissue Growth Strategies Examples of Adaptation in Implant Applications A Final Comment on Adaptation 197 References 199 Bibliography 201

Chapter 11 In Vitro Tissue Growth and Replantation 203 11.1 General Considerations 203 11.2 What Is Tissue Engineering? 204 11.3 The Cell-Receptor Paradigm 206 11.4 Matrices and Cell Sources 210 11.

5 Chapter 11 In Vitro Tissue Growth and Replantation General Considerations What Is Tissue Engineering? The Cell-Receptor Paradigm Matrices and Cell Sources Thinking Twice about Tissue Engineering Some Final Comments 220 Ref erences 222 Bibliography 223 Chapter 12 Allergie Foreign Body Response Specific vs. Nonspecific Response Mechanisms of Immune Response Classes of Hypersensitivity Reactions Hypersensitivity Reactions Associated with Implants Final Comment 240 Ref erences 241 Bibliography 243 Chapter 13 Chemical and Foreign-Body Carcinogenesis Definitions Chemical Carcinogenesis Foreign Body Carcinogenesis Nonspecific Carcinogenesis Evidence for Implant Carcinogenesis in Humans 263 Ref erences 268 Bibliography 270 Chapter 14 Mineral Metabolism Introduction Iron Metabolism Chromium Metabolism Human Dietary Metal Intake 285 Ref erences 288 Bibliography 289 Chapter 15 Systemic Distribution and Excretion Introduction Movement of Solid Bodies Transport of Dissolved Species Distribution and Excretion of Dissolved Species 301

15.5 Final Comment 311 References 312 Bibliography 315 Chapter 16 Effects of Degradation Products on Remote Organ Function 317 16.1 Introduction 317 16.2 Examples of Systemic Effects 318 16.

6 15.5 Final Comment 311 References 312 Bibliography 315 Chapter 16 Effects of Degradation Products on Remote Organ Function Introduction Examples of Systemic Effects A Review of Systemic Aspects of Host Response A Final Comment 323 References 325 Bibliography 326 Interpart 2 Implant Materials: Clinical Performance Introduction An Example: Total Hip Replacement A Final Word 332 References 332 Bibliography 333 Part IV Methods of Testing for Biological Performance Chapter 17 In Vitro Test Methods Test Strategies In Vitro Test Types, Tissue Culture Tests Blood Contact Tests Final Comments 350 References 351 Bibliography 353 Chapter 18 In Vivo Implant Models Introduction Test Types A Final Comment 370 References 370 Bibliography 373 Appendices 374

Chapter 19 Clinical Testing of Implant Materials 383 19.1 Goal of Clinical Trials 383 19.2 Design of Clinical Trials 384 19.3 Conclusions from Clinical Trials 392 19.

7 Chapter 19 Clinical Testing of Implant Materials Goal of Clinical Trials Design of Clinical Trials Conclusions from Clinical Trials Aspects of the Decision for General Clinical Use Final Comments 398 References 400 Bibliography 401 Chapter 20 Standardization and Regulation of Implant Materials Historical Perspective Drug Standardization Activities Biomaterials Standardization Activities U.S. Federal Regulation of Medical Devices and Biomaterials Regulation of Materials for Implants The Biomaterials Supply "Crisis" 422 References 423 Bibliography 424 Chapter 21 Design and Selection of Implant Materials Introduction The Design Process The Value of Prospective Design 438 References 439 Bibliography 440 Chapter 22 Clinical Perfo rmance of Biomaterials Historical Aspects Procedures for Device Retrieval and Analysis Common Concerns about Device Retrieval and Analysis Proposed National Implant Data Retrieval and Analysis Program (NIDRA) Elements of a NIDRA System Autopsy Retrieval Studies Concluding Remarks 456 References 457 Bibliography 457 Glossary 459 G.l Introduction 459 G.2 Glossary 460

8 G.3 Deprecated Terms 469 References 470 Index 471

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