Table of Contents
Preface v
Contributing authors xiv
List of Abbreviations xvii
Chapter 1 Biomaterials - characteristics, history, applications Robert B. Heimann 1
1.1 Biomaterials and the concept of biocompatibility 2
1.1.1 Role of biomaterials 2
1.1.2 A universe of biomaterials 2
1.1.3 Hybrid nanocomposites 5
1.1.4 Four generations of biomaterials 8
1.1.5 Biocompatibility 9
1.1.6 Osseointegration 12
1.1.7 Medical devices and medical equipment: definitions 16
1.1.8 Bioinspired materials 17
1.2 A brief history of biomaterials 18
1.2.1 Metallic biomaterials 19
1.2.2 Ceramics 28
1.2.3 Polymers 38
1.3 Selected types and applications of medical devices 47
1.3.1 Externally worn biomimetic devices 49
1.3.2 Implantable devices with physical replacement function 50
1.3.3 Mechanically active devices 53
1.3.4 Biologically interacting devices 60
1.3.5 Electrically active devices 62
1.3.6 Drug and gene delivery vehicles 69
1.3.7 Three-dimensional-printed scaffolds for tissue engineering 72
Chapter 2 Types and properties of biomaterials Robert B. Heimann Mitsuo Niinomi Matthias Schnabelrauch 75
2.1 Metals (Robert B. Heimann, Mitsuo Niinomi) 75
2.1.1 Corrosion-resistant metals 75
2.1.2 Biodegradable metals 124
2.2 Ceramics (Robert B. Heimann) 132
2.2.1 Bioinert/biotolerant ceramics 133
2.2.2 Bioactive ceramics 165
2.3 Polymers (Matthias Schnabelrauch) 212
2.3.1 Introduction 212
2.3.2 Classification of polymers 213
2.3.3 Molecular structure 213
2.3.4 Molecular mass and molecular mass distribution 215
2.3.5 Solid state of polymers 216
2.3.6 Thermal and mechanical behavior 217
2.3.7 Biostability and biodegradabitity 218
2.3.8 Natural polymers 222
2.3.9 Synthetic polymers 236
Chapter 3 Synthesis and process technology of biomaterials Robert B. Heimann Mitsuo Niinomi Matthias Schnabelrauch 251
3.1 Metals (Robert B. Heimann, Mitsuo Niinomi) 251
3.1.1 Stainless steels 251
3.1.2 CoCr alloys 254
3.1.3 Titanium and titanium alloys 257
3.1.4 Magnesium 283
3.2 Ceramics (Robert B. Heimann) 291
3.2.1 General properties of advanced ceramics 291
3.2.2 Manufacturing of ceramic powders and their consolidation 293
3.2.3 Sintering 294
3.2.4 Alumina 298
3.2.5 Zirconia 304
3.2.6 Carbon 310
3.2.7 Calcium phosphates 312
3.2.8 Bioglasses 334
3.3 Polymers (Matthias Schnabelrauch) 337
3.3.1 General synthesis principles for polymers 337
3.3.2 Polymer processing 342
3.4 Surface functionalization (Robert B. Heimann) 359
3.4.1 Physical functionalization 360
3.4.2 Chemical functionalization 360
3.4.3 Biological functionalization 362
3.4.4 Radiative functionalization 365
Chapter 4 In vitro and in vivo performance of biomaterials and biomedical devices Christine Knabe Doaa Adel-Khattab Christian Müller-Mai Barbara Nebe Michael Schlosser Robert B. Heimann Hans-Jürgen Kock 369
4.1 Biological performance of biomaterials and biomedical devices (Christine Knabe, Doaa Adel-Khattab, Christian Müller-Mai) 369
4.1.1 Principles of how to test new biomaterials and medical devices 369
4.1.2 Tissue and host response and classification of biomaterials 371
4.1.3 Examples of polymer- and ceramic-based bone grafting materials 376
4.1.4 Translation from the laboratory to the clinic of rapidly resorbable calcium alkali orthophosphate bone grafting materials 378
4.1.5 Drug-releasing biomaterials and medical devices 384
4.1.6 Significance of host factors and device registries 385
4.2 In vitro studies and cell adhesion to biomaterials (Barbara Nebe) 385
4.2.1 Cellular structures important for cell adhesion and signaling 387
4.2.2 Cell adhesion mechanisms 392
4.2.3 Cell-matrix binding and its influence on apoptosis 394
4.2.4 Implications 396
4.3 In vivo evaluation of inflammatory and immunological reactions (Michael Schlosser) 396
4.3.1 Medical implants and biocompatibility 396
4.3.2 Interactions between implanted biomaterials and the host's inflammatory response 400
4.3.3 The complex and interdisciplinary issue of biocompatibility testing 407
4.3.4 The in vivo evaluation of immunological/inflammatory response 409
4.3.5 Conclusion 421
4.4 Interaction of biomaterials with living tissue: osseoinduction (Robert B. Heimann) 422
4.4.1 Introduction 422
4.4.2 Types of tissue 422
4.4.3 Osseoconduction and osseoinduction 423
4.4.4 Levels of interaction 424
4.5 Long-term performance of surgical implants (Hans-Jürgen Kock) 427
4.5.1 Introduction 427
4.5.2 Preclinical evaluation in the long-term perspective 428
4.5.3 Clinical evaluation 437
4.5.4 Total hip replacement - An example of long-term result evaluation 447
4.5.5 Summary and conclusion 449
Chapter 5 Quality management and regulatory affairs Robert B. Heimann 451
5.1 Quality management of biomaterials and biomedical devices 451
5.1.1 Standard specifications 452
5.1.2 Laboratory evaluation 453
5.1.3 Clinical trials 461
5.1.4 Reviewing 462
5.1.5 Other considerations and ethical guidelines 463
5.2 Regulatory affairs for biomaterials and biomedical devices 463
5.3 The route of biomaterials from inception to market 465
Chapter 6 Future challenges, anticipated developments, and outlook Robert B. Heimann 467
6.1 Introduction 467
6.2 Biomimetics 468
6.3 Arthroplasty and scaffolds for regenerative medicine 469
6.4 Biodegradable metals 471
6.5 Bioceramics 472
6.6 Carbon materials 474
6.7 Osseoconductive coatings 474
6.8 Bioinspired hybrid nanocomposites 475
6.9 Surface-active bioglasses 476
6.10 Hydrogels 476
6.11 Polymers 477
6.12 Hemocompatible coatings 478
6.13 Dentistry 478
6.14 Three-dimensional-printed scaffolds 479
6.15 Third-generation biomaterials 480
6.16 Fourth-generation biomaterials 481
6.17 Biosensors 482
6.18 Biological materials 483
6.19 Antibacterial medical textiles 484
6.20 Cell-biomaterial interactions 484
6.21 Artificial intelligence 485
6.22 Far-future materials and bioengineering tools 486
6.23 Conclusion and implications 487
Appendix A Standard specifications for biomaterials and biomedical devices (Robert B. Heimann) 489
Appendix B Current world market situation of biomaterials and biomedical devices (Robert B. Heimann) 503
Appendix C Socioeconomic role of biomaterials: the example of hip endoprostheses (Robert B. Heimann) 511
References 515
Glossary 591
Index 607
