FOURTH

EDITION

BIOLOGICAL PERFORMANCE of MATERIALS

Fundamentals of Biocompatibility

Jonathan Black

QfP) Taylor &. Francis

> ^ J Taylor & Francis G r o u p
Boca Raton London N e w 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
3 3 5 6 7 10 12 14 15

C h a p t e r 1 Biocompatibility: Definitions and Issues 1.1 Introduction 1.2 Biological Performance 1.3 Consensus Definitions 1.4 Discussion 1.5 The Discipline of Biomaterials 1.6 Afterword: Paradigmatic Shift References Bibliography

C h a p t e r 2 Introduction to the Biological Environment 2.1 General Considerations 2.2 Comparison of External and Internal Conditions 2.3 Problems in Definition of the Biological Environment 2.4 Elements of the Biological Environment 2.5 Implant Life History 2.6 Preimplantation Handling Effects References Bibliography

17 17 17 18 20 22 28 29 30

Part II

Material Response: Function and Degradation of Materials In Vivo

35 35 35 36 38 42 43 44 46 46 47

C h a p t e r 3 Swelling and Leaching 3.1 Introduction 3.2 Fick's Laws of Diffusion 3.3 Absorption 3.4 Examples of Undesirable Absorption 3.5 Osmotic Equilibrium 3.6 Leaching 3.7 Example of Planned Leaching: Drug Release 3.8 Effects of Swelling and Leaching References Bibliography

C h a p t e r 4 Corrosion and Dissolution 4.1 Chemistry of Corrosion 4.2 Classification of Reactions 4.3 The Pourbaix Diagram 4.4 The Electrochemical Series 4.5 Corrosion Rate 4.6 Potential-Current Relationships in Corrosion 4.7 Forms of Corrosion 4.8 Corrosion in Implant Applications 4.9 Engineering Variables Affecting Corrosion Rates 4.10 Corrosion Factors Peculiar to Biological Environments 4.11 Ceramic Dissolution 4.12 Polymer Dissolution 4.13 Final Remarks '. References Bibliography

49 49 50 51 54 56 57 58 64 66 67 68 69 70 70 71

C h a p t e r 5 Reactions of Biological Molecules with Biomaterial Surfaces 5.1 Introduction 5.2 Denaturation 5.3 Organometallic Compounds 5.4 Mechanical Aspects of Interfaces 5.5 Results of Interfacial Adhesion of Molecules 5.6 Effects of Charged Interfaces and Ions 5.7 Final Comments References Bibliography

73 73 74 74 77 80 82 83 84 84

C h a p t e r 6 Mechanics of Materials: Deformation and Failure 6.1 Introduction 6.2 Mechanics of Materials 6.3 Elastic Modulus 6.4 Yield Strength 6.5 Fracture Strength 6.6 Final Comment References Bibliography C h a p t e r 7 Friction and Wear 7.1 Introduction 7.2 Friction 7.3 Lubrication

87 87 87 90 96 97 104 104 105 107 107 107 109

7.4 Wear 7.5 Conclusions References t Bibliography I n t e r p a r t 1 Implant Materials: Properties 11.1 Introduction 11.2 Metals 11.3 Polymers 11.4 Ceramics 11.5 Composites References Bibliography

114 122 122 123 125 125 126 129 131 132 134 135

Part III

Host Response: Biological Effects of I m p l a n t s

139 139 139 150 155 160 160 162

C h a p t e r 8 The Inflammatory Process 8.1 Introduction 8.2 The Inflammatory Response 8.3 Infection 8.4 Effects of Implant Degradation Products 8.5 A Final Comment References Bibliography

C h a p t e r 9 Coagulation and Hemolysis 9.1 Introduction 9.2 The Coagulation Cascade 9.3 Approaches to Thromboresistant Materials Development 9.4 Hemolysis 9.5 Final Comments References Bibliography

165 165 165 170 176 179 180 181

C h a p t e r 1 0 Adaptation 10.1 Introduction 10.2 Tissue Growth Strategies 10.3 Examples of Adaptation in Implant Applications 10.4 A Final Comment on Adaptation References Bibliography

183 183 183 186 197 199 201

C h a p t e r 11 In Vitro Tissue Growth and Replantation 11.1 General Considerations 11.2 What Is Tissue Engineering? 11.3 The Cell-Receptor Paradigm 11.4 Matrices and Cell Sources 11.5 Thinking Twice about Tissue Engineering 11.6 Some Final Comments Ref erences Bibliography

203 203 204 206 210 214 220 222 223

C h a p t e r 1 2 Allergie Foreign Body Response 12.1 Specific vs. Nonspecific Response 12.2 Mechanisms of Immune Response 12.3 Classes of Hypersensitivity Reactions 12.4 Hypersensitivity Reactions Associated with Implants 12.5 Final Comment Ref erences Bibliography

225 225 226 230 230 240 241 243

C h a p t e r 1 3 Chemical and Foreign-Body Carcinogenesis 13.1 Definitions 13.2 Chemical Carcinogenesis 13.3 Foreign Body Carcinogenesis 13.4 Nonspecific Carcinogenesis 13.5 Evidence for Implant Carcinogenesis in Humans Ref erences Bibliography C h a p t e r 1 4 Mineral Metabolism 14.1 Introduction 14.2 Iron Metabolism 14.3 Chromium Metabolism 14.4 Human Dietary Metal Intake Ref erences Bibliography

245 245 246 257 262 263 268 270 273 273 274 283 285 288 289

C h a p t e r 1 5 Systemic Distribution and Excretion 15.1 Introduction 15.2 Movement of Solid Bodies 15.3 Transport of Dissolved Species 15.4 Distribution and Excretion of Dissolved Species

291 291 291 296 301

15.5 Final Comment References Bibliography

311 312 315

C h a p t e r 1 6 Effects of Degradation Products on Remote Organ Function 16.1 Introduction 16.2 Examples of Systemic Effects 16.3 A Review of Systemic Aspects of Host Response 16.4 A Final Comment References Bibliography

317 317 318 321 323 325 326

I n t e r p a r t 2 Implant Materials: Clinical Performance 12.1 Introduction 12.2 An Example: Total Hip Replacement 12.3 A Final Word References Bibliography

327 327 330 332 332 333

Part IV

M e t h o d s of Testing for Biological Performance

337 337 338 338 347 350 351 353

C h a p t e r 1 7 In Vitro Test Methods 17.1 Test Strategies 17.2 In Vitro Test Types 17.3 Tissue Culture Tests 17.4 Blood Contact Tests 17.5 Final Comments References Bibliography

C h a p t e r 18 In Vivo Implant Models 18.1 Introduction 18.2 Test Types 18.3 A Final Comment References Bibliography Appendices

355 355 358 370 370 373 374

C h a p t e r 19 Clinical Testing of Implant Materials 19.1 Goal of Clinical Trials 19.2 Design of Clinical Trials 19.3 Conclusions from Clinical Trials 19.4 Aspects of the Decision for General Clinical Use 19.5 Final Comments References Bibliography C h a p t e r 2 0 Standardization and Regulation of Implant Materials 20.1 Historical Perspective 20.2 Drug Standardization Activities 20.3 Biomaterials Standardization Activities 20.4 U.S. Federal Regulation of Medical Devices and Biomaterials 20.5 Regulation of Materials for Implants 20.6 The Biomaterials Supply "Crisis" References Bibliography

383 383 384 392 394 398 400 401

403 403 404 406 415 419 422 423 424

C h a p t e r 2 1 Design and Selection of Implant Materials 21.1 Introduction 21.2 The Design Process 21.3 The Value of Prospective Design References Bibliography

427 427 429 438 439 440

C h a p t e r 2 2 Clinical Perfo rmance of Biomaterials 22.1 Historical Aspects 22.2 Procedures for Device Retrieval and Analysis 22.3 Common Concerns about Device Retrieval and Analysis 22.4 Proposed National Implant Data Retrieval and Analysis Program (NIDRA) 22.5 Elements of a NIDRA System 22.6 Autopsy Retrieval Studies 22.7 Concluding Remarks References Bibliography

441 441 443 447 450 451 455 456 457 457

Glossary G.l Introduction G.2 Glossary

459 459 460

G.3 Deprecated Terms References

469 470

Index

471