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 1.5 The Discipline of Biomaterials 10 1.6 Afterword: Paradigmatic Shift 12 References 14 Bibliography 15 Chapter 2 Introduction to the Biological Environment 17 2.1 General Considerations 17 2.2 Comparison of External and Internal Conditions 17 2.3 Problems in Definition of the Biological Environment 18 2.4 Elements of the Biological Environment 20 2.5 Implant Life History 22 2.6 Preimplantation Handling Effects 28 References 29 Bibliography 30 Part II Material Response: Function and Degradation of Materials In Vivo Chapter 3 Swelling and Leaching 35 3.1 Introduction 35 3.2 Fick's Laws of Diffusion 35 3.3 Absorption 36 3.4 Examples of Undesirable Absorption 38 3.5 Osmotic Equilibrium 42 3.6 Leaching 43 3.7 Example of Planned Leaching: Drug Release 44 3.8 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 4.6 Potential-Current Relationships in Corrosion 57 4.7 Forms of Corrosion 58 4.8 Corrosion in Implant Applications 64 4.9 Engineering Variables Affecting Corrosion Rates 66 4.10 Corrosion Factors Peculiar to Biological Environments 67 4.11 Ceramic Dissolution 68 4.12 Polymer Dissolution 69 4.13 Final Remarks '. 70 References 70 Bibliography 71 Chapter 5 Reactions of Biological Molecules with Biomaterial Surfaces 73 5.1 Introduction 73 5.2 Denaturation 74 5.3 Organometallic Compounds 74 5.4 Mechanical Aspects of Interfaces 77 5.5 Results of Interfacial Adhesion of Molecules 80 5.6 Effects of Charged Interfaces and Ions 82 5.7 Final Comments 83 References 84 Bibliography 84 Chapter 6 Mechanics of Materials: Deformation and Failure 87 6.1 Introduction 87 6.2 Mechanics of Materials 87 6.3 Elastic Modulus 90 6.4 Yield Strength 96 6.5 Fracture Strength 97 6.6 Final Comment 104 References 104 Bibliography 105 Chapter 7 Friction and Wear 107 7.1 Introduction 107 7.2 Friction 107 7.3 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 11.5 Composites 132 References 134 Bibliography 135 Part III Host Response: Biological Effects of Implants Chapter 8 The Inflammatory Process 139 8.1 Introduction 139 8.2 The Inflammatory Response 139 8.3 Infection 150 8.4 Effects of Implant Degradation Products 155 8.5 A Final Comment 160 References 160 Bibliography 162 Chapter 9 Coagulation and Hemolysis 165 9.1 Introduction 165 9.2 The Coagulation Cascade 165 9.3 Approaches to Thromboresistant Materials Development 170 9.4 Hemolysis 176 9.5 Final Comments 179 References 180 Bibliography 181 Chapter 10 Adaptation 183 10.1 Introduction 183 10.2 Tissue Growth Strategies 183 10.3 Examples of Adaptation in Implant Applications 186 10.4 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 Thinking Twice about Tissue Engineering 214 11.6 Some Final Comments 220 Ref erences 222 Bibliography 223 Chapter 12 Allergie Foreign Body Response 225 12.1 Specific vs. Nonspecific Response 225 12.2 Mechanisms of Immune Response 226 12.3 Classes of Hypersensitivity Reactions 230 12.4 Hypersensitivity Reactions Associated with Implants 230 12.5 Final Comment 240 Ref erences 241 Bibliography 243 Chapter 13 Chemical and Foreign-Body Carcinogenesis 245 13.1 Definitions 245 13.2 Chemical Carcinogenesis 246 13.3 Foreign Body Carcinogenesis 257 13.4 Nonspecific Carcinogenesis 262 13.5 Evidence for Implant Carcinogenesis in Humans 263 Ref erences 268 Bibliography 270 Chapter 14 Mineral Metabolism 273 14.1 Introduction 273 14.2 Iron Metabolism 274 14.3 Chromium Metabolism 283 14.4 Human Dietary Metal Intake 285 Ref erences 288 Bibliography 289 Chapter 15 Systemic Distribution and Excretion 291 15.1 Introduction 291 15.2 Movement of Solid Bodies 291 15.3 Transport of Dissolved Species 296 15.4 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 16.3 A Review of Systemic Aspects of Host Response 321 16.4 A Final Comment 323 References 325 Bibliography 326 Interpart 2 Implant Materials: Clinical Performance 327 12.1 Introduction 327 12.2 An Example: Total Hip Replacement 330 12.3 A Final Word 332 References 332 Bibliography 333 Part IV Methods of Testing for Biological Performance Chapter 17 In Vitro Test Methods 337 17.1 Test Strategies 337 17.2 In Vitro Test Types, 338 17.3 Tissue Culture Tests 338 17.4 Blood Contact Tests 347 17.5 Final Comments 350 References 351 Bibliography 353 Chapter 18 In Vivo Implant Models 355 18.1 Introduction 355 18.2 Test Types 358 18.3 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 19.4 Aspects of the Decision for General Clinical Use 394 19.5 Final Comments 398 References 400 Bibliography 401 Chapter 20 Standardization and Regulation of Implant Materials 403 20.1 Historical Perspective 403 20.2 Drug Standardization Activities 404 20.3 Biomaterials Standardization Activities 406 20.4 U.S. Federal Regulation of Medical Devices and Biomaterials 415 20.5 Regulation of Materials for Implants 419 20.6 The Biomaterials Supply "Crisis" 422 References 423 Bibliography 424 Chapter 21 Design and Selection of Implant Materials 427 21.1 Introduction 427 21.2 The Design Process 429 21.3 The Value of Prospective Design 438 References 439 Bibliography 440 Chapter 22 Clinical Perfo rmance of Biomaterials 441 22.1 Historical Aspects 441 22.2 Procedures for Device Retrieval and Analysis 443 22.3 Common Concerns about Device Retrieval and Analysis 447 22.4 Proposed National Implant Data Retrieval and Analysis Program (NIDRA) 450 22.5 Elements of a NIDRA System 451 22.6 Autopsy Retrieval Studies 455 22.7 Concluding Remarks 456 References 457 Bibliography 457 Glossary 459 G.l Introduction 459 G.2 Glossary 460
G.3 Deprecated Terms 469 References 470 Index 471