Preface xxi
Part 1 Introduction 1
1 Historical Perspectives on Biomedical Coatings in Medical Devices 3
M. Hendriks and P.T. Cahalan
1.1 Introduction 4
1.2 Improving Physical Properties of Biomaterials: Hydrophilic, Lubricious Coatings 7
1.3 Modulating Host-Biomaterial Interactions: Biologically Active Coatings 7
1.4 Bioinert Coatings Redressed: Nonfouling Coatings 15
1.5 Future Biomedical Coatings 16
References 18
Part 2 Coating Applications 27
2 Antimicrobial Coatings and Other Surface Modifications for Infection Prevention 29
Marc W. Mittelman and Nimisha Mukherjee
2.1 Introduction 29
2.2 Genesis of Device-Related Infections 35
2.3 Antimicrobial Coatings 38
2.4 Non-Eluting Antimicrobial Surfaces 49
2.5 Coating and Surface Modification Technologies 53
2.6 Regulatory Considerations 57
2.7 Future Challenges 58
References 61
3 Drug Delivery Coatings for Coronary Stents 75
Shrirang V. Ranade and Kishore Udipi
3.1 Introduction 75
3.2 Polymer Coatings for DES 81
3.3 Biostable (Non-Bioabsorbable) Polymers 86
3.4 Bioabsorbable Polymers 99
3.5 Concluding Remarks 103
References 104
4 Coatings for Radiopacity 115
Scott Schewe and David Glocker
4.1 Principles of Radiography 115
4.2 Use of Radiopaque Materials in Medical Devices 116
4.3 Radiopaque Fillers 117
4.4 Types of Radiopaque Fillers 117
4.5 Other Radiographic Materials and Coating Systems 121
4.6 Radiopaque Coatings by Physical Vapor Deposition 122
4.7 Challenges in Producing Radiopaque Coatings Using PVD 124
4.8 Gold Radiopaque Coatings 125
4.9 Tantalum Radiopaque Coatings 126
4.10 Summary 129
References 130
5 Biocompatibility and Medical Device Coatings 131
Joe McGonigle, Thomas J. Webster, and Garima Bhardwaj
5.1 Introduction 131
5.2 Challenges with Medical Devices 134
5.3 Examples of Products Coated to Improve Biocompatibility 148
5.4 Types of Biocompatible Coatings 157
5.5 Commercialization 170
5.6 Summary 172
References 172
6 Tribological Coatings for Biomedical Devices 181
Peter Martin
6.1 Introduction 181
6.2 Hard Thin Film Coatings for Implants 187
6.3 Binary Carbon-Based Thin Film Materials: Diamond, Hard Carbon and Amorphous Carbon 194
6.4 Progress of DLC, ta-C and a-C:H Films for Hip and Knee Implants 200
6.5 Wear-Resistant Coatings for Stents and Catheters 208
6.6 Wear-Resistant Coatings for Angioplasty Devices 210
6.7 Scalpel Blades and Surgical Instruments 211
6.8 Multifunctional, Nanostructured, Nanolaminate, and Nanocomposite Tribological Materials 211
References 222
Part 3 Coating and Surface Modification Methods 233
7 Dip Coating 235
Donald M. Copenhagen
7.1 Description and Basic Steps 235
7.2 Equipment and Coating Application 236
7.3 Coating Solution Containers 237
7.4 Coating Parameters and Controls 238
7.5 Role of Solution Viscosity 240
7.6 Coating Problems 241
7.7 Process Considerations 244
8 Inkjet Technology and Its Application in Biomedical Coating
Bogdan V. Antohe, David B. Wallace, and Patrick W. Cooley 247
8.1 Introduction 247
8.2 Inkjet Background 248
8.3 Equipment Used 260
8.4 Capabilities 268
8.5 Limitations and Ways around Them 280
8.6 Manufacturing Advantages and Future Directions 293
8.7 Conclusions 299
References 300
9 Direct Capillary Printing in Medical Device Manufacture 309
William J. Grande
9.1 Introduction 309
9.2 Fundamental Elements of Direct Capillary Printing 320
9.3 Practical Operational Considerations 337
9.4 Manufacturing Considerations 349
9.5 Medical Device Examples 352
9.6 Conclusions 367
Acknowledgments 369
References 369
10 Sol-Gel Coating Methods in Biomedical Systems 373
Bakul C. Dave
10.1 Introduction 374
10.2 Overview of Sol-Gel Coatings in Biomedical Systems 377
10.3 The Sol-Gel Process 381
10.4 Coating Methods and Processes 385
10.5 Factors influencing Coatings Characteristics/Performance 390
10.6 Summary and Concluding Remarks 394
References 395
11 Chemical Vapor Deposition 403
Kenneth K. S. Lau
11.1 Introduction 403
11.2 Process Description 405
11.3 Process Mechanism 410
11.4 Technology Advances 414
11.5 Future Outlook 442
References 443
12 Introduction to Plasmas Used for Coating Processes 457
David A. Glocker
12.1 Introduction 457
12.2 DC Glow Discharges 459
12.3 RF Glow Discharges 463
12.4 RF Diode Glow Discharges 464
12.5 Ionization in RF Diode Glow Discharges 466
12.6 Inductively Coupled RF Discharges 466
12.7 Mid-Frequency AC Discharges 468
12.8 Pulsed DC Discharges 469
12.9 Comparison of Plasma Properties 470
12.10 Plasma Species 470
12.11 Summary 471
References 472
13 Ion Implantation: Tribological Applications 473
Peter Martin
13.1 Introduction 473
13.2 Applications 474
13.3 Nanocrystalline Diamond 487
Reference 492
14 Plasma-Enhanced Chemical Vapor Deposition 495
Kenneth K. S. Lau
14.1 Introduction 495
14.2 Process Description 497
14.3 Plasma Effects on Materials Deposition 501
14.4 Future Outlook 520
References 521
15 Sputter Deposition and Sputtered Coatings for Biomedical Applications 531
David A. Glocker
15.1 Introduction 531
15.2 Overview of Sputter Coating 533
15.3 Characteristics of Sputtered Atoms 536
15.4 Sputtering Cathodes 539
15.5 Relationship between Process Parameters and Coating Properties 541
15.6 Biased Sputtering 544
15.7 Adhesion and Stress in Sputtered Coatings 545
15.8 Sputtering Electrically Insulating Materials 546
15.9 Recent Developments 549
15.10 Summary and Conclusions 549
References 550
16 Cathodic Arc Vapor Deposition 553
Gary Vergason
16.1 Introduction 553
16.2 Medical Uses of Cathodic Arc Titanium Nitride Coatings 556
16.3 Brief History and Commercial Advancement of Cathodic Arcs 557
16.4 Review of Arc Devices 559
16.5 Description of PVD Coating Manufacturing 561
16.6 Macroparticle Generation and Mitigation 567
16.7 Considerations for Coating Success 568
16.8 Materials Used in Biomedical PVD Coatings 576
References 576
Part 4 Functional Tests 581
17 Antimicrobial Coatings Efficacy Evaluation 583
Nimisha Mukherjee and Marc W. Mittelman
17.1 Introduction 583
17.2 In-Vitro Methods 584
17.3 In-Vivo (Animal) Methods 590
17.4 Equipment and Laboratory Resources 590
17.5 Human Clinical Trial Considerations 590
17.6 Regulatory Considerations 590
References 596
18 Mechanical Characterization of Biomaterials: Functional Tests for Hardness 605
Vincent Jardret
18.1 Introduction 605
18.2 Basic Principles of Hardness and Indentation Testing 607
18.3 Depth-Sensing Indentation Testing 611
18.4 Dynamic Indentation Testing: A More Advanced Hardness Measurement Technique for More Complex Material Behavior 617
18.5 Special Case of Coatings Configuration under Indentation Testing 626
18.6 Conclusions 628
References 629
19 Adhesion Measurement of Thin Films and Coatings: Relevance to Biomedical Applications 631
Wei-Sheng Lei, Kash Mittal, and Ajay Kumar
19.1 Introduction 631
19.2 Mechanical Test Methods of Adhesion Measurement 634
19.3 Summary and Remarks 654
Appendix 656
References 665
20 Functional Tests for Biocompatability 671
Joe McConigle and Thomas J. Webster
20.1 Introduction 671
20.2 Inflammation 672
20.3 Blood Compatibility 675
20.4 Wound Healing 685
20.5 Encapsulation 688
20.6 Tissue Integration 691
20.7 Vascularization 692
20.8 Toxicity 699
20.9 Infection 700
20.10 When to Move In Vivo? 701
References 702
21 Analytical Requirements for Drug Eluting Stents 707
Lori Alquier and Shrirang Ranade
21.1 Introduction 707
21.2 Instrumentation 708
21.3 API and Excipient Characterization 709
21.4 Analytical Methods 712
21.5 Conclusion 719
References 719
Part 5 Regulatory Overview 723
22 Regulations for Medical Devices and Coatings 725
Robert J. Klepinski
22.1 Introduction 725
22.2 Types of Regulated Products 726
22.3 Scope of Regulation 732
22.4 Marketing Clearance of Medical Devices 733
22.5 Comparison to EU Regulation 737
22.6 Good Manufacturing Practices 737
Part 6 Future of Coating Technologies 743
23 The Future of Biomedical Coatings Technologies 745
Shrirang Ranade and David Glocker
23.1 Introduction 745
23.2 The Continuing Evolution of Biomaterials 749
23.3 Tissue Engineering and Regenerative Medicine 749
23.4 Coating Process Development 750
References 751
