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E-raamat: Medical Coatings and Deposition Technologies [Wiley Online]

Edited by David Glocker, Edited by Shrirang Ranade

Teised formaadid

Other digital carrier (Hind: 226,90 €) - 08-Aug-2016

Formaat: 800 pages
Ilmumisaeg: 19-Jul-2016
Kirjastus: Wiley-Scrivener
ISBN-10: 1119308712
ISBN-13: 9781119308713

Teised raamatud teemal:

Wiley Online
Hind: 263,27 €*
* hind, mis tagab piiramatu üheaegsete kasutajate arvuga ligipääsu piiramatuks ajaks

Formaat: 800 pages
Ilmumisaeg: 19-Jul-2016
Kirjastus: Wiley-Scrivener
ISBN-10: 1119308712
ISBN-13: 9781119308713

Teised raamatud teemal:

Rohkem infot Wiley Online kohta

Raamatu kodulehekülg: https://onlinelibrary.wiley.com/doi/book/10.1002/9781119308713

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.

Preface

xxi

Part 1 Introduction

(26)

1 Historical Perspectives on Biomedical Coatings in Medical Devices

(24)

M. Hendriks

P.T. Cahalan

1.1 Introduction

(1)

1.2 Improving Physical Properties of Biomaterials: Hydrophilic, Lubricious Coatings

(2)

1.3 Modulating Host-Biomaterial Interactions: Biologically Active Coatings

(8)

1.3.1 Heparin Coatings

(2)

1.3.2 Antimicrobial Coatings

(1)

1.3.2.1 Antimicrobial-Releasing Materials

(1)

1.3.2.2 Nonadhesive Surfaces

(1)

1.3.2.3 Promoting Tissue Integration

(2)

1.3.3 Drug-Eluting Coatings

(1)

1.4 Bioinert Coatings Redressed? Nonfouling Coatings

(1)

1.5 Future Biomedical Coatings

(2)

References

(9)

Part 2 Coating Applications

(206)

2 Antimicrobial Coatings and Other Surface Modifications for Infection Prevention

(46)

Marc W. Mittelman

Nimisha Mukherjee

2.1 Introduction

(6)

2.2 Genesis of Device-Related Infections

(3)

2.3 Antimicrobial Coatings

(11)

2.3.1 Antibiotics

(1)

2.3.2 Non-Antibiotic Antimicrobial Compounds

(1)

2.3.2.1 Organic Compounds

(1)

2.3.2.2 Silver and Other Metals

(1)

2.4 Non-Eluting Antimicrobial Surfaces

(4)

2.4.1 Pendant Chemistries

(1)

2.4.1.1 Zwitterionic Surfaces

(1)

2.4.1.2 Topographical Modifications

(1)

2.5 Coating and Surface Modification Technologies

(4)

2.5.1 Passive-Release Technologies

(1)

2.5.1.1 Diffusion-Based Antimicrobial Coatings

(1)

2.5.1.2 Solvent Imbibing of Antimicrobials

(1)

2.5.2 Sputter Coating Systems

(1)

2.5.3 Covalent Surface Modification

(1)

2.5.4 Other Technologies

(1)

2.6 Regulatory Considerations

(1)

2.7 Future Challenges

(3)

2.7.1 Antimicrobial Resistance

(3)

2.7.2 Biocompatibility

(1)

References

(14)

3 Drug Delivery Coatings for Coronary Stents

(40)

Shrirang V. Ranade

Kishore Udipi

3.1 Introduction

(6)

3.1.1 Coronary Artery Disease: Treatment Options and Issues

(3)

3.1.2 Bare-Metal Stents

(1)

3.1.3 Drug-Eluting Stents

(1)

3.2 Polymer Coatings for DES

(5)

3.2.1 Requirements for Coronary Stent Coatings

(1)

3.2.2 Physical and Chemical Properties

(1)

3.2.2.1 Stability

(1)

3.2.2.2 Sterilization

(1)

3.2.2.3 Compatibility with the Drug and Drug Elution

(1)

3.2.3 Biological Properties

(1)

3.2.3.1 Biocompatibility with Vascular Tissue

(1)

3.2.4 Coating Optimization

(1)

3.3 Biostable (Non-Bioabsorbable) Polymers

(13)

3.3.1 Poly(Ethylene-Co-Vinyl Acetate)/Poly(n-Butylmethacrylate)/Parylene C

(2)

3.3.2 Poly(Styrene-block-Isobutylene-block-Styrene) (SIBS)

(3)

3.3.3 Poly(Vinylidene Fluoride-co-Hexafluoropropylene)/ Poly(n-Butyl Methacrylate)

(2)

3.3.4 Phosphorylcholine-Based Polymer Coating System (PC)

(2)

3.3.5 BIOLINX® Polymer Coating

(3)

3.4 Bioabsorbable Polymers

(4)

3.5 Concluding Remarks

103

(1)

References

104

(11)

4 Coatings for Radiopacity

115

(16)

Scott Schewe

David A. Glocker

4.1 Principles of Radiography

115

(1)

4.2 Use of Radiopaque Materials in Medical Devices

116

(1)

4.3 Radiopaque Fillers

117

(1)

4.3.1 Purpose of Radiopaque Fillers in Polymers

117

(1)

4.4 Types of Radiopaque Fillers

117

(4)

4.4.1 Barium Compounds

117

(1)

4.4.2 Bismuth Compounds

118

(1)

4.4.3 Metals

119

(2)

4.4.4 Material Modifications to Enhance Radiopacity

121

(1)

4.5 Other Radiographic Materials and Coating Systems

121

(1)

4.5.1 Metal-Loaded Polymer Suspensions

121

(1)

4.6 Radiopaque Coatings by Physical Vapor Deposition

122

(2)

4.7 Challenges in Producing Radiopaque Coatings Using PVD

124

(1)

4.8 Gold Radiopaque Coatings

125

(1)

4.9 Tantalum Radiopaque Coatings

126

(3)

4.10 Summary

129

(1)

References

130

(1)

5 Biocompatibility and Medical Device Coatings

131

(50)

Joseph McGonigle

Thomas J. Webster

Garima Bhardwaj

5.1 Introduction

131

(3)

5.2 Challenges with Medical Devices

134

(14)

5.2.1 Toxicity

134

(3)

5.2.2 Inflammation

137

(2)

5.2.3 Blood Compatibility

139

(3)

5.2.4 Wound Healing

142

(2)

5.2.5 Encapsulation

144

(1)

5.2.6 Tissue Integration

145

(1)

5.2.7 Vascularization

145

(1)

5.2.8 Infection

146

(2)

5.3 Examples of Products Coated to Improve Biocompatibility

148

(9)

5.3.1 Stents

148

(2)

5.3.2 Surgical Mesh Materials

150

(1)

5.3.3 Orthopedic Implants

151

(2)

5.3.4 Sensors

153

(1)

5.3.5 Pacemaker Leads

154

(1)

5.3.6 Neurological Devices

154

(2)

5.3.7 Catheters/Endotracheal Tubes

156

(1)

5.3.8 Ocular

156

(1)

5.4 Types of Biocompatible Coatings

157

(13)

5.4.1 Polymers and Surface Modification

157

(1)

5.4.2 Surface Preparation and Polymer Deposition

157

(3)

5.4.3 Covalent Bonding

160

(1)

5.4.4 Biocompatible Biomaterials

161

(1)

5.4.5 Hydrophilic and Nonfouling Polymers

161

(2)

5.4.6 Small Molecule Pharmaceuticals

163

(1)

5.4.7 Extracellular Matrix Proteins and Peptides

163

(2)

5.4.8 Heparin and Polysaccharides

165

(1)

5.4.9 Antibody and Other Biomolecule Coatings

166

(1)

5.4.10 Orthopedics/Calcium Phosphate/BMP

166

(2)

5.4.11 Porosity

168

(1)

5.4.12 Surface Roughness

169

(1)

5.5 Commercialization

170

(2)

5.5.1 Cost Challenges

170

(1)

5.5.2 Manufacturing Challenges

171

(1)

5.5.3 Animal-Derived Materials

171

(1)

5.6 Summary

172

(1)

References

172

(9)

6 Tribological Coatings for Biomedical Devices

181

(52)

Peter Martin

6.1 Introduction

181

(6)

6.2 Hard Thin Film Coatings for Implants

187

(7)

6.2.1 Titanium- and Chromium-Based Thin Film Materials

188

(6)

6.3 Binary Carbon-Based Thin Film Materials: Diamond, Hard Carbon and Amorphous Carbon

194

(6)

6.3.1 Tribological Properties

194

(6)

6.4 Progress of DLC, ta-C and a-C:H Films for Hip and Knee Implants

200

(8)

6.4.1 Diamond-like Carbon

200

(5)

6.4.2 Biocompatibility and Thrombus Formation

205

(1)

6.4.3 Aluminum Oxide Thin Films

206

(2)

6.5 Wear-Resistant Coatings for Stents and Catheters

208

(2)

6.6 Wear-Resistant Coatings for Angioplasty Devices

210

(1)

6.7 Scalpel Blades and Surgical Instruments

210

(1)

6.8 Multifunctional, Nanostructured, Nanolaminate, and Nanocomposite Tribological Materials

210

(12)

References

222

(11)

Part 3 Coating and Surface Modification Methods

233

(348)

7 Dip Coating

235

(12)

Donald M. Copenhagen

7.1 Description and Basic Steps

235

(1)

7.2 Equipment and Coating Application

236

(1)

7.2.1 Hand Dipping

236

(1)

7.2.2 Mechanical Dipping

236

(1)

7.3 Coating Solution Containers

237

(1)

7.4 Coating Parameters and Controls

238

(2)

7.5 Role of Solution Viscosity

240

(1)

7.5.1 Viscosity and Withdrawal Velocity

240

(1)

7.5.2 Molecular Weight of Polymers

240

(1)

7.5.3 Viscosity as a Function of Solids Content

241

(1)

7.6 Coating Problems

241

(3)

7.6.1 Partial Coating

241

(1)

7.6.2 Vibration

241

(1)

7.6.3 Humidity

242

(1)

7.6.4 Run Back

242

(1)

7.6.5 Orange Peel

242

(1)

7.6.6 Chatter

242

(1)

7.6.7 Craters

243

(1)

7.6.8 Bubbles

243

(1)

7.6.9 Poor Adhesion

243

(1)

7.7 Process Considerations

244

(3)

8 Inkjet Technology and Its Application in Biomedical Coating

247

(62)

Bogdan V. Antohe

David B. Wallace

Patrick W. Cooley

8.1 Introduction

247

(1)

8.2 Inkjet Background

248

(12)

8.2.1 Continuous Inkjet (CIJ)

248

(2)

8.2.2 Drop-on-Demand (DOD)

250

(1)

8.2.2.1 General Discussion

250

(1)

8.2.2.2 Less Common Actuation Methods

250

(1)

8.2.2.3 Thermal Inkjet

252

(1)

8.2.2.4 Piezoelectric Inkjet

254

(4)

8.2.3 Comparison of CIJ and DOD

258

(2)

8.2.4 Drop Formation

260

(1)

8.3 Equipment Used

260

(8)

8.3.1 Dispenser/Printhead

261

(2)

8.3.2 Motion

263

(1)

8.3.3 Auxiliary Equipment

264

(1)

8.3.3.1 Drive Electronics

264

(1)

8.3.3.2 Pressure Control

264

(1)

8.3.3.3 Temperature Control

265

(1)

8.3.3.4 Environmental Control

265

(1)

8.3.3.5 Optics

266

(1)

8.3.3.6 Maintenance

266

(1)

8.3.3.7 Other Auxiliary Components

267

(1)

8.3.4 Software

267

(1)

8.3.5 Printing Platform Manufacturers

268

(1)

8.4 Capabilities

268

(12)

8.4.1 Surface Activation and Passivation

268

(1)

8.4.1.1 Microarrays

268

(1)

8.4.1.2 Tissue MALDI - Application of Matrix Solutions

268

(1)

8.4.1.3 Nerve Conduits - Fabrication and Coating to Create a Nerve Growth Factor (NGF) Gradient

270

(1)

8.4.1.4 Coating for Activation

271

(5)

8.4.2 Drug Release/Delivery

276

(4)

8.5 Limitations and Ways around Them

280

(13)

8.5.1 Requirements of Dispensed Materials

280

(1)

8.5.1.1 Viscosity

280

(1)

8.5.1.2 Surface Tension

281

(1)

8.5.1.3 Volatility/Boiling Point

281

(1)

8.5.2 Operational Limitations

281

(1)

8.5.3 Liquid - Substrate Interaction

282

(1)

8.5.3.1 Single or Multiple Drops Placed at one Location

282

(1)

8.5.3.2 Feature Generation (Lines or Area Coverage) by Drop Distribution

284

(3)

8.5.4 Failure Modes

287

(1)

8.5.4.1 Clogging

288

(1)

8.5.4.2 Drop Placement Errors

288

(2)

8.5.5 Minimizing Operational Limits and Failure

290

(1)

8.5.5.1 Printhead

290

(1)

8.5.5.2 Solution Formulation

290

(1)

8.5.5.3 Substrate Treatment and Containment Features

292

(1)

8.5.5.4 Maintenance

292

(1)

8.5.5.5 Other Elements of the Printing Process

293

(1)

8.6 Manufacturing Advantages and Future Directions

293

(6)

8.6.1 Advantages

293

(1)

8.6.2 Potential Applications

294

(1)

8.6.2.1 Tissue Engineering

295

(1)

8.6.2.2 Scaffolds

295

(1)

8.6.2.3 Skin Regeneration

295

(1)

8.6.2.4 Transdermal Drug Delivery

297

(1)

8.6.2.5 Visual Prosthesis

298

(1)

8.6.2.6 Packaging - Adhesives

298

(1)

8.7 Conclusions

299

(1)

References

300

(9)

9 Direct Capillary Printing in Medical Device Manufacture

309

(64)

William J. Grande

9.1 Introduction

309

(11)

9.1.1 Origins and Brief History

310

(2)

9.1.2 Competitive Technologies

312

(1)

9.1.2.1 Direct Writing

312

(1)

9.1.2.2 Competitors Outside of Direct Writing

313

(1)

9.1.2.3 Example of the Evolution of Manufacturing Techniques over Time

314

(2)

9.1.3 Strategic Considerations for Medical Device Manufacture

316

(3)

9.1.4 Summary

319

(1)

9.2 Fundamental Elements of Direct Capillary Printing

320

(17)

9.2.1 Ink Systems

321

(1)

9.2.1.1 Single-Phase Inks

322

(1)

9.2.1.2 Multi-Phase Inks

323

(1)

9.2.1.3 Curing Temperature

323

(4)

9.2.2 Applying Force to the Ink

327

(1)

9.2.3 The Fluidic Channel

328

(1)

9.2.4 The Pen Tip

328

(3)

9.2.5 The Motion Control System

331

(1)

9.2.6 The Ink-Substrate-Printhead System

331

(2)

9.2.7 Special Considerations for Medical Devices

333

(1)

9.2.7.1 Adhesion and Cohesion Testing

333

(1)

9.2.7.2 Biocompatibility

333

(1)

9.2.7.3 Electrochemical Stability

335

(1)

9.2.7.4 Conflict Minerals

335

(2)

9.3 Practical Operational Considerations

337

(12)

9.3.1 Starting, Stopping, and Idling

337

(1)

9.3.2 Substrate Effects

338

(3)

9.3.3 Ink Effects

341

(1)

9.3.4 Motion Effects

342

(1)

9.3.5 Lateral Misalignment, Eccentricity, and Substrate Shape Errors

343

(2)

9.3.6 Pattern and Tool Path Effects

345

(3)

9.3.7 Multi-Level Pattern Effects

348

(1)

9.3.8 Process Integration

348

(1)

9.4 Manufacturing Considerations

349

(3)

9.4.1 Low Volume Manufacturing

350

(1)

9.4.2 High Volume Manufacturing

351

(1)

9.5 Medical Device Examples

352

(15)

9.5.1 Tube and Catheter Devices

352

(1)

9.5.1.1 Instrumented Endotracheal Tube for Cardiac Output Monitoring

352

(1)

9.5.1.2 LED-Instrumented Medical Devices for Photodynamic Therapy

355

(2)

9.5.2 Balloon-Based Devices

357

(1)

9.5.2.1 Improved Radiopaque Markings for a Bone Fracture Repair Catheter

357

(1)

9.5.2.2 Ablation Electrodes for Denervation

361

(2)

9.5.3 Ceramic- and Metal-Based Devices

363

(1)

9.5.3.1 Bipolar Hemostasis Ablation Probe

364

(1)

9.5.3.2 Immersion Heater for Ablative Therapies

365

(1)

9.5.4 3D Printing

366

(1)

9.5.4.1 Flat Flexible Electrode Array

366

(1)

9.5.4.2 Stents

367

(1)

9.6 Conclusions

367

(2)

Acknowledgments

369

(1)

References

369

(4)

10 Sol-Gel Coating Methods in Biomedical Systems

373

(30)

Bakul C. Dave

10.1 Introduction

374

(3)

10.2 Overview of Sol-Gel Coatings in Biomedical Systems

377

(4)

10.2.1 Tailored Surfaces

379

(1)

10.2.2 Surface Passivation

379

(1)

10.2.3 Biocompatibility

380

(1)

10.2.4 Release and Growth Media

381

(1)

10.3 The Sol-Gel Process

381

(4)

10.3.1 Chemistry and Processing

382

(3)

10.4 Coating Methods and Processes

385

(5)

10.4.1 Dip Coating

386

(1)

10.4.2 Spin Coating

387

(1)

10.4.3 Spray Coating

388

(1)

10.4.4 Self-Assembly

388

(1)

10.4.5 Other Methods

389

(1)

10.5 Factors Influencing Coatings Characteristics/Performance

390

(4)

10.5.1 Processing Conditions

391

(1)

10.5.2 Native Composition/Excipients

392

(1)

10.5.3 Porosity

393

(1)

10.5.4 Deposition Method

393

(1)

10.5.5 Uniformity and Homogeneity

394

(1)

10.6 Summary and Concluding Remarks

394

(3)

References

397

(6)

11 Chemical Vapor Deposition

403

(54)

Kenneth K.S. Lau

11.1 Introduction

403

(2)

11.2 Process Description

405

(5)

11.2.1 Precursor Selection

406

(1)

11.2.2 Vapor Delivery

407

(1)

11.2.3 Reactor Configuration

407

(1)

11.2.4 Precursor Activation

408

(1)

11.2.5 Pressure Management

409

(1)

11.2.6 Exhaust Handling

410

(1)

11.2.7 Other Peripherals

410

(1)

11.3 Process Mechanism

410

(4)

11.3.1 Mass Transport

411

(1)

11.3.2 Reaction Kinetics

412

(1)

11.3.3 Thermodynamics

412

(1)

11.3.4 Rate-Limiting Behavior

413

(1)

11.4 Technology Advances

414

(28)

11.4.1 Thermal CVD of Graphene

414

(7)

11.4.2 HWCVD of Nanodiamond

421

(5)

11.4.3 ALD of Oxides and Nitrides

426

(7)

11.4.4 iCVD of Polymers

433

(9)

11.5 Future Outlook

442

(1)

References

443

(14)

12 Introduction to Plasmas Used for Coating Processes

457

(16)

David A. Glocker

12.1 Introduction

457

(2)

12.2 DC Glow Discharges

459

(4)

12.3 RF Glow Discharges

463

(1)

12.4 RF Diode Glow Discharges

464

(2)

12.5 Ionization in RF Diode Glow Discharges

466

(1)

12.6 Inductively Coupled RF Discharges

466

(2)

12.7 Mid-Frequency AC Discharges

468

(1)

12.8 Pulsed DC Discharges

469

(1)

12.9 Comparison of Plasma Properties

470

(1)

12.10 Plasma Species

470

(1)

12.11 Summary

471

(1)

References

472

(1)

13 Ion Implantation: Tribological Applications

473

(22)

Peter Martin

13.1 Introduction

473

(1)

13.2 Applications

474

(13)

13.2.1 Nitrogen Ion Implantation

474

(2)

13.2.2 Implantation of C+ Ions

476

(3)

13.2.3 Titanium Alloys

479

(1)

13.2.4 Tribological Testing

479

(8)

13.3 Nanocrystalline Diamond

487

(5)

13.3.1 Ti Ion Implanting into DLC

491

(1)

Reference

492

(3)

14 Plasma-Enhanced Chemical Vapor Deposition

495

(36)

Kenneth K.S. Lau

14.1 Introduction

495

(2)

14.2 Process Description

497

(4)

14.2.1 Plasma Configuration

498

(1)

14.2.2 Plasma Chemistry

499

(1)

14.2.3 Plasma Field

500

(1)

14.2.4 Plasma Diagnostics

501

(1)

14.3 Plasma Effects on Materials Deposition

501

(19)

14.3.1 Plasma Configuration: Titanium Dioxide

502

(5)

14.3.2 Plasma Chemistry: Ultrananocrystalline Diamond

507

(6)

14.3.3 Plasma Electric Field: Carbon Nanofibers

513

(7)

14.4 Future Outlook

520

(1)

References

521

(10)

15 Sputter Deposition and Sputtered Coatings for Biomedical Applications

531

(22)

David A. Glocker

15.1 Introduction

531

(2)

15.2 Overview of Sputter Coating

533

(3)

15.3 Characteristics of Sputtered Atoms

536

(3)

15.4 Sputtering Cathodes

539

(2)

15.5 Relationship between Process Parameters and Coating Properties

541

(3)

15.6 Biased Sputtering

544

(1)

15.7 Adhesion and Stress in Sputtered Coatings

545

(1)

15.8 Sputtering Electrically Insulating Materials

546

(3)

15.9 Recent Developments

549

(1)

15.10 Summary and Conclusions

549

(1)

References

550

(3)

16 Cathodic Arc Vapor Deposition

553

(28)

Gary Vergason

16.1 Introduction

553

(3)

16.2 Medical Uses of Cathodic Arc Titanium Nitride Coatings

556

(1)

16.3 Brief History and Commercial Advancement of Cathodic Arcs

557

(2)

16.4 Review of Arc Devices

559

(2)

16.5 Description of PVD Coating Manufacturing

561

(6)

16.5.1 Order Entry

562

(1)

16.5.2 Cleaning

563

(1)

16.5.3 Coating Fixturing and Masking

563

(1)

16.5.4 PVD Coating

563

(1)

16.5.4.1 Substrate Loading

564

(1)

16.5.4.2 Pump Down

565

(1)

16.5.4.3 Substrate Heating and Cleaning

565

(1)

16.5.4.4 Coating

565

(1)

16.5.4.5 Cooldown

566

(1)

16.5.4.6 Unloading

566

(1)

16.6 Macroparticle Generation and Mitigation

567

(1)

16.7 Considerations for Coating Success

568

(8)

16.7.1 Surface Finish and Contaminants

569

(1)

16.7.1.1 Heat Treating

570

(1)

16.7.1.2 Abrasive and Chemical Cleaning

570

(1)

16.7.1.3 Unbalanced Final Grinding

570

(1)

16.7.1.4 Low Temperature Materials

571

(1)

16.7.1.5 Press Fit Components

571

(1)

16.7.1.6 Polishing Carriers

571

(1)

16.7.2 Cleaning for PVD

572

(1)

16.7.2.1 Ultrasonic Cleaning

572

(1)

16.7.2.2 Plasma Cleaning

572

(1)

16.7.3 PVD Masking and Fixturing

573

(1)

16.7.4 Inspection and Certification

573

(1)

16.7.4.1 Coating Thickness

574

(1)

16.7.4.2 Coating Adhesion

575

(1)

16.7.4.3 Post Cleaning and Shipping

576

(1)

16.8 Materials Used in Biomedical PVD Coatings

576

(1)

References

576

(5)

Part 4 Functional Tests

581

(142)

17 Antimicrobial Coatings Efficacy Evaluation

583

(22)

Nimisha Mukherjee

Marc W. Mittelman

17.1 Introduction

583

(1)

17.2 In-Vitro Methods

584

(6)

17.2.1 Biofilm Development

584

(2)

17.2.2 Quantitative Recovery of Cells from Surfaces

586

(1)

17.2.3 Zone-of-Inhibition (ZOI) Assays

587

(1)

17.2.4 Antimicrobial Surface Activity (Agar Overlay Technique)

587

(1)

17.2.5 Direct Observation

588

(1)

17.2.5.1 Epifluorescence Microscopy

588

(1)

17.2.5.2 Scanning and Transmission Electron Microscopy

588

(1)

17.2.5.3 Atomic Force Microscopy

589

(1)

17.2.6 Characterization of Bacterial and Fungal Cells

590

(1)

17.3 In-Vivo (Animal) Methods

590

(1)

17.4 Equipment and Laboratory Resources

590

(1)

17.5 Human Clinical Trial Considerations

590

(1)

17.6 Regulatory Considerations

590

(6)

17.6.1 U.S. FDA

590

(5)

17.6.2 EU

595

(1)

17.6.3 Japan, Australia

595

(1)

References

596

(9)

18 Mechanical Characterization of Biomaterials: Functional Tests for Hardness

605

(26)

Vincent Jardret

18.1 Introduction

605

(2)

18.2 Basic Principles of Hardness and Indentation Testing

607

(4)

18.2.1 Classic Hardness Scales

607

(1)

18.2.1.1 Brinell Hardness Number

607

(1)

18.2.1.2 Meyer Hardness

610

(1)

18.2.1.3 Vickers Hardness

610

(1)

18.2.1.4 Knoop Hardness

610

(1)

18.2.1.5 Rockwell Hardness Scale

611

(1)

18.3 Depth-Sensing Indentation Testing

611

(6)

18.3.1 Determination of the Contact Depth

612

(3)

18.3.2 Determination of the Contact Area

615

(1)

18.3.3 Determination of the Nanoindentation Hardness

616

(1)

18.3.4 Determination of the Reduced and Young's Elastic Modulus

617

(1)

18.4 Dynamic Indentation Testing: A More Advanced Hardness Measurement Technique for More Complex Material Behavior

617

(9)

18.4.1 Continuous Stiffness Measurement Technique

618

(1)

18.4.2 Constant Strain Rate Experiments

619

(4)

18.4.3 Viscoelastic Measurements

623

(1)

18.4.4 Case of Strain-Dependent Behavior

623

(2)

18.4.5 Case of Very Soft Materials and Influence of Adhesion

625

(1)

18.5 Special Case of Coatings Configuration Under Indentation Testing

626

(2)

18.6 Conclusions

628

(1)

References

629

(2)

19 Adhesion Measurement of Thin Films and Coatings: Relevance to Biomedical Applications

631

(40)

Wei-Sheng Le

Kash Mittal

Ajay Kumar

19.1 Introduction

631

(3)

19.2 Mechanical Test Methods of Adhesion Measurement

634

(20)

19.2.1 Peel Test

634

(1)

19.2.2 Scribe (Scratch) Test

635

(5)

19.2.3 Pull-Off Test

640

(3)

19.2.4 Blister Test

643

(1)

19.2.5 Microindentation Test

644

(4)

19.2.6 Small Punch Test

648

(1)

19.2.7 Edge Delamination Test

649

(3)

19.2.8 Four-Point Bending Test

652

(2)

19.3 Summary and Remarks

654

(2)

Appendix

656

(9)

References

665

(6)

20 Functional Tests for Biocompatibility

671

(36)

Joseph McConigle

Thomas J. Webster

20.1 Introduction

671

(1)

20.2 Inflammation

672

(3)

20.2.1 Macrophage Activation

673

(1)

20.2.2 Cytokines

673

(1)

20.2.3 Histology

674

(1)

20.3 Blood Compatibility

675

(10)

20.3.1 Protein and Fibrinogen Adsorption

676

(4)

20.3.2 Platelet Adhesion and Activation

680

(1)

20.3.3 Hemolysis

681

(1)

20.3.4 Complement Activation

681

(1)

20.3.5 Clotting and Thrombin Activity Testing

682

(1)

20.3.6 Blood Loop Assays

682

(1)

20.3.7 In Vivo Thrombosis Assays

683

(2)

20.4 Wound Healing

685

(3)

20.4.1 Cell Growth

685

(2)

20.4.2 Skin Wound Healing Models

687

(1)

20.5 Encapsulation

688

(3)

20.5.1 Drug Transport

689

(1)

20.5.2 Histology (Foreign Body Response)

690

(1)

20.6 Tissue Integration

691

(1)

20.6.1 Cell Attachment

691

(1)

20.6.2 Orthopedics/Mineralization/Osteoblast/Osteoclast Activation

692

(1)

20.7 Vascularization

692

(7)

20.7.1 Endothelial In Vitro Cell Assays

693

(1)

20.7.2 Angiogenesis In Vitro Assays

694

(1)

20.7.3 Endothelialization

695

(2)

20.7.4 Vascular Staining and Imaging

697

(1)

20.7.5 Functional Blood Flow Measurements

698

(1)

20.8 Toxicity

699

(1)

20.8.1 In Vitro Tests

699

(1)

20.8.2 In Vivo Tests

699

(1)

20.9 Infection

700

(1)

20.9.1 In Vitro Tests

700

(1)

20.9.2 In Vivo Tests

701

(1)

20.10 When to Move In Vivo?

701

(1)

References

702

(5)

21 Analytical Requirements for Drug Eluting Stents

707

(16)

Lori Alquier

Shrirang V. Ranade

21.1 Introduction

707

(1)

21.2 Instrumentation

708

(1)

21.3 API and Excipient Characterization

709

(3)

21.4 Analytical Methods

712

(7)

21.4.1 Appearance

712

(1)

21.4.2 Identification

713

(1)

21.4.3 Drug Assay and Related Impurities/ Degradation Products

713

(1)

21.4.4 Residual Solvents (Organic Volatile Impurities)

714

(1)

21.4.5 Uniformity of Dosage Units (Content Uniformity)

714

(1)

21.4.6 Polymer Molecular Weight and Content

715

(1)

21.4.7 Drug Elution

716

(2)

21.4.8 Leachables and Extractables

718

(1)

21.4.9 Specifications

719

(1)

21.5 Conclusion

719

(1)

References

719

(4)

Part 5 Regulatory Overview

723

(20)

22 Regulations for Medical Devices and Coatings

725

(18)

Robert J. Klepinski

22.1 Introduction

725

(1)

22.2 Types of Regulated Products

726

(6)

22.2.1 Devices

726

(2)

22.2.2 Drugs

728

(1)

22.2.3 Biologics

729

(1)

22.2.4 Combination Products

729

(2)

22.2.5 Human Tissue

731

(1)

22.3 Scope of Regulation

732

(1)

22.4 Marketing Clearance of Medical Devices

733

(4)

22.4.1 PMA

734

(1)

22.4.2 Premarket Notification (PMN or 510(k))

734

(2)

22.4.3 Marketing Clearance of Combination Products

736

(1)

22.5 Comparison to EU Regulation

737

(2)

22.6 Good Manufacturing Practices

739

(6)

22.6.1 Device GMPs

739

(1)

22.6.2 Drug GMPs

740

(1)

22.6.3 Combination Products

741

(2)

Part 6 Future of Coating Technologies

743

(10)

23 The Future of Biomedical Coatings Technologies

745

(8)

Shrirang V. Ranade

David A. Glocker

23.1 Introduction

745

(4)

23.2 The Continuing Evolution of Biomaterials

749

(1)

23.3 Tissue Engineering and Regenerative Medicine

749

(1)

23.4 Coating Process Development

750

(1)

References

751

(2)

Index

753

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.

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E-raamat: Medical Coatings and Deposition Technologies [Wiley Online]

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