Medical Coatings and Deposition Technologies

Medical Coatings and Deposition Technologies is an important new addition to the libraries of medical device designers and manufacturers. Coatings enable the properties of the surface of a device to be controlled independently from the underlying bulk properties; they are often critical to the performance of the device and their use is rapidly growing. This book provides an introduction to many of the most important types of coatings used on modern medical devices as well as descriptions of the techniques by which they are applied and methods for testing their efficacy.  Developers of new medical devices and those responsible for producing them will find it an important reference when deciding if a particular functionality can be provided by a coating and what limitations may apply in a given application. Written as a practical guide and containing many specific coating examples and a large number of references for further reading, the book will also be useful to students in materials science & engineering with an interest in medical devices.

Chapters on antimicrobial coatings as well as coatings for biocompatibility, drug delivery, radiopacity and hardness are supported by chapters describing key liquid coating processes, plasma-based processes and chemical vapor deposition. Many types of coatings can be applied by more than one technique and the reader will learn the tradeoffs given the relevant design, manufacturing and economic constraints. The chapter on regulatory considerations provides important perspectives regarding the marketing of these coatings and medical devices.

Dr. David Glocker has worked in the fields of thin film deposition and plasma treatment for over 35 years. He spent fourteen years at the Eastman Kodak Company, where he led a group responsible for research on PVD coatings and coating processes and methods for the plasma modification of polymers. In 1993 he founded Isoflux Incorporated to manufacture cylindrical magnetron sputtering cathodes and develop coating processes employing that technology. Several medical device manufacturers now use Isoflux cathodes and related patents in both research and manufacturing. Dr. Glocker is an inventor or co-inventor on 32 US patents as well as a number of foreign counterparts and is the author of numerous articles and presentations. He recently retired from Isoflux and consults.

Dr. Shrirang Ranade, Technical Development Leader at Genentech, Inc., a member of the Roche Group, has spent over 15 years working within large medical device and Pharma (F. Hoffman-La Roche, Johnson & Johnson and Boston Scientific) in the field of biomaterials, coatings and drug delivery devices. He obtained a Bachelor of Engineering from the University of Poona, a Master of Science from the University of Manchester Institute of Science & Technology and later a Ph.D. in Polymer Science from the University of Connecticut. Through his career he has been involved in research and development of medical devices for combination products in several forms: coronary drug eluting stents, balloon catheters, sinuplasty devices, orthopaedic scaffolds, biodegradable coatings and lately an implantable ocular drug delivery system.

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

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