Medical Coatings and Deposition Technologies

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 xxiPart 1 Introduction 11 Historical Perspectives on Biomedical Coatings in Medical Devices 3M. Hendriks and P.T. Cahalan1.1 Introduction 41.2 Improving Physical Properties of Biomaterials: Hydrophilic, Lubricious Coatings 71.3 Modulating Host-Biomaterial Interactions: Biologically Active Coatings 71.4 Bioinert Coatings Redressed: Nonfouling Coatings 151.5 Future Biomedical Coatings 16References 18Part 2 Coating Applications 272 Antimicrobial Coatings and Other Surface Modifications for Infection Prevention 29Marc W. Mittelman and Nimisha Mukherjee2.1 Introduction 292.2 Genesis of Device-Related Infections 352.3 Antimicrobial Coatings 382.4 Non-Eluting Antimicrobial Surfaces 492.5 Coating and Surface Modification Technologies 532.6 Regulatory Considerations 572.7 Future Challenges 58References 613 Drug Delivery Coatings for Coronary Stents 75Shrirang V. Ranade and Kishore Udipi3.1 Introduction 753.2 Polymer Coatings for DES 813.3 Biostable (Non-Bioabsorbable) Polymers 863.4 Bioabsorbable Polymers 993.5 Concluding Remarks 103References 1044 Coatings for Radiopacity 115Scott Schewe and David Glocker4.1 Principles of Radiography 1154.2 Use of Radiopaque Materials in Medical Devices 1164.3 Radiopaque Fillers 1174.4 Types of Radiopaque Fillers 1174.5 Other Radiographic Materials and Coating Systems 1214.6 Radiopaque Coatings by Physical Vapor Deposition 1224.7 Challenges in Producing Radiopaque Coatings Using PVD 1244.8 Gold Radiopaque Coatings 1254.9 Tantalum Radiopaque Coatings 1264.10 Summary 129References 1305 Biocompatibility and Medical Device Coatings 131Joe McGonigle, Thomas J. Webster, and Garima Bhardwaj5.1 Introduction 1315.2 Challenges with Medical Devices 1345.3 Examples of Products Coated to Improve Biocompatibility 1485.4 Types of Biocompatible Coatings 1575.5 Commercialization 1705.6 Summary 172References 1726 Tribological Coatings for Biomedical Devices 181Peter Martin6.1 Introduction 1816.2 Hard Thin Film Coatings for Implants 1876.3 Binary Carbon-Based Thin Film Materials: Diamond, Hard Carbon and Amorphous Carbon 1946.4 Progress of DLC, ta-C and a-C:H Films for Hip and Knee Implants 2006.5 Wear-Resistant Coatings for Stents and Catheters 2086.6 Wear-Resistant Coatings for Angioplasty Devices 2106.7 Scalpel Blades and Surgical Instruments 2116.8 Multifunctional, Nanostructured, Nanolaminate, and Nanocomposite Tribological Materials 211References 222Part 3 Coating and Surface Modification Methods 2337 Dip Coating 235Donald M. Copenhagen7.1 Description and Basic Steps 2357.2 Equipment and Coating Application 2367.3 Coating Solution Containers 2377.4 Coating Parameters and Controls 2387.5 Role of Solution Viscosity 2407.6 Coating Problems 2417.7 Process Considerations 2448 Inkjet Technology and Its Application in Biomedical CoatingBogdan V. Antohe, David B. Wallace, and Patrick W. Cooley 2478.1 Introduction 2478.2 Inkjet Background 2488.3 Equipment Used 2608.4 Capabilities 2688.5 Limitations and Ways around Them 2808.6 Manufacturing Advantages and Future Directions 2938.7 Conclusions 299References 3009 Direct Capillary Printing in Medical Device Manufacture 309William J. Grande9.1 Introduction 3099.2 Fundamental Elements of Direct Capillary Printing 3209.3 Practical Operational Considerations 3379.4 Manufacturing Considerations 3499.5 Medical Device Examples 3529.6 Conclusions 367Acknowledgments 369References 36910 Sol-Gel Coating Methods in Biomedical Systems 373Bakul C. Dave10.1 Introduction 37410.2 Overview of Sol-Gel Coatings in Biomedical Systems 37710.3 The Sol-Gel Process 38110.4 Coating Methods and Processes 38510.5 Factors influencing Coatings Characteristics/Performance 39010.6 Summary and Concluding Remarks 394References 39511 Chemical Vapor Deposition 403Kenneth K. S. Lau11.1 Introduction 40311.2 Process Description 40511.3 Process Mechanism 41011.4 Technology Advances 41411.5 Future Outlook 442References 44312 Introduction to Plasmas Used for Coating Processes 457David A. Glocker12.1 Introduction 45712.2 DC Glow Discharges 45912.3 RF Glow Discharges 46312.4 RF Diode Glow Discharges 46412.5 Ionization in RF Diode Glow Discharges 46612.6 Inductively Coupled RF Discharges 46612.7 Mid-Frequency AC Discharges 46812.8 Pulsed DC Discharges 46912.9 Comparison of Plasma Properties 47012.10 Plasma Species 47012.11 Summary 471References 47213 Ion Implantation: Tribological Applications 473Peter Martin13.1 Introduction 47313.2 Applications 47413.3 Nanocrystalline Diamond 487Reference 49214 Plasma-Enhanced Chemical Vapor Deposition 495Kenneth K. S. Lau14.1 Introduction 49514.2 Process Description 49714.3 Plasma Effects on Materials Deposition 50114.4 Future Outlook 520References 52115 Sputter Deposition and Sputtered Coatings for Biomedical Applications 531David A. Glocker15.1 Introduction 53115.2 Overview of Sputter Coating 53315.3 Characteristics of Sputtered Atoms 53615.4 Sputtering Cathodes 53915.5 Relationship between Process Parameters and Coating Properties 54115.6 Biased Sputtering 54415.7 Adhesion and Stress in Sputtered Coatings 54515.8 Sputtering Electrically Insulating Materials 54615.9 Recent Developments 54915.10 Summary and Conclusions 549References 55016 Cathodic Arc Vapor Deposition 553Gary Vergason16.1 Introduction 55316.2 Medical Uses of Cathodic Arc Titanium Nitride Coatings 55616.3 Brief History and Commercial Advancement of Cathodic Arcs 55716.4 Review of Arc Devices 55916.5 Description of PVD Coating Manufacturing 56116.6 Macroparticle Generation and Mitigation 56716.7 Considerations for Coating Success 56816.8 Materials Used in Biomedical PVD Coatings 576References 576Part 4 Functional Tests 58117 Antimicrobial Coatings Efficacy Evaluation 583Nimisha Mukherjee and Marc W. Mittelman17.1 Introduction 58317.2 In-Vitro Methods 58417.3 In-Vivo (Animal) Methods 59017.4 Equipment and Laboratory Resources 59017.5 Human Clinical Trial Considerations 59017.6 Regulatory Considerations 590References 59618 Mechanical Characterization of Biomaterials: Functional Tests for Hardness 605Vincent Jardret18.1 Introduction 60518.2 Basic Principles of Hardness and Indentation Testing 60718.3 Depth-Sensing Indentation Testing 61118.4 Dynamic Indentation Testing: A More Advanced Hardness Measurement Technique for More Complex Material Behavior 61718.5 Special Case of Coatings Configuration under Indentation Testing 62618.6 Conclusions 628References 62919 Adhesion Measurement of Thin Films and Coatings: Relevance to Biomedical Applications 631Wei-Sheng Lei, Kash Mittal, and Ajay Kumar19.1 Introduction 63119.2 Mechanical Test Methods of Adhesion Measurement 63419.3 Summary and Remarks 654Appendix 656References 66520 Functional Tests for Biocompatability 671Joe McConigle and Thomas J. Webster20.1 Introduction 67120.2 Inflammation 67220.3 Blood Compatibility 67520.4 Wound Healing 68520.5 Encapsulation 68820.6 Tissue Integration 69120.7 Vascularization 69220.8 Toxicity 69920.9 Infection 70020.10 When to Move In Vivo? 701References 70221 Analytical Requirements for Drug Eluting Stents 707Lori Alquier and Shrirang Ranade21.1 Introduction 70721.2 Instrumentation 70821.3 API and Excipient Characterization 70921.4 Analytical Methods 71221.5 Conclusion 719References 719Part 5 Regulatory Overview 72322 Regulations for Medical Devices and Coatings 725Robert J. Klepinski22.1 Introduction 72522.2 Types of Regulated Products 72622.3 Scope of Regulation 73222.4 Marketing Clearance of Medical Devices 73322.5 Comparison to EU Regulation 73722.6 Good Manufacturing Practices 737Part 6 Future of Coating Technologies 74323 The Future of Biomedical Coatings Technologies 745Shrirang Ranade and David Glocker23.1 Introduction 74523.2 The Continuing Evolution of Biomaterials 74923.3 Tissue Engineering and Regenerative Medicine 74923.4 Coating Process Development 750References 751