Title Details

MARTIN CULJAT, PhD, is Adjunct Assistant Professor in the UCLA Departments of Bioengineering and Surgery and the Engineering Research Director of the UCLA Center for Advanced Surgical and Interventional Technology (CASIT), a research center that promotes collaboration between medicine and engineering.

RAHUL SINGH, PhD, is Adjunct Assistant Professor in the UCLA Departments of Bioengineering and Surgery. He leads several collaborative research projects at the UCLA Center for Advanced Surgical and Interventional Technology (CASIT).

HUA LEE, PhD, is Professor in the Department of Electrical and Computer Engineering at UC Santa Barbara. Well known for his pioneering research laboratory, Dr. Lee is also the author of three other books on imaging technology and engineering.

CONTRIBUTORS xix

PART I INTRODUCTION TO MEDICAL DEVICES 1

1. Introduction 3
Martin Culjat

1.1 History of Medical Devices 3

1.2 Medical Device Terminology 6

1.3 Purpose of the Book 10

2. Design of Medical Devices 11
Gregory Nighswonger

2.1 Introduction 11

2.2 The Medical Device Design Environment 11

2.2.1 US Regulation 12

2.2.2 Differences in European Regulation 13

2.2.3 Standards 14

2.3 Basic Design Phases 15

2.3.1 Feasibility 15

2.3.2 Planning and Organization—Assembling the Design Team 16

2.3.3 When to Involve Regulatory Affairs 17

2.3.4 Conceptualizing and Review 17

2.3.5 Testing and Refinement 20

2.3.6 Proving the Concept 20

2.3.7 Pilot Testing and Release to Manufacturing 22

2.4 Postmarket Activities 25

2.5 Final Note 25

PART II MINIMALLY INVASIVE DEVICES AND TECHNIQUES 27

3. Instrumentation for Laparoscopic Surgery 29
Camellia Racu-Keefer, Scott Um, Martin Culjat, and Erik Dutson

3.1 Introduction 29

3.2 Basic Principles 31

3.3 Laparoscopic Instrumentation 34

3.3.1 Trocars 34

3.3.2 Standard Laparoscopic Instruments 37

3.3.3 Additional Laparoscopic Instruments 42

3.3.4 Specimen Retrieval Bags 44

3.3.5 Disposable Instruments 44

3.4 Innovative Applications 45

3.5 Summary and Future Applications 46

4. Surgical Instruments in Ophthalmology 49
Allen Y. Hu, Robert M. Beardsley, and Jean-Pierre Hubschman

4.1 Introduction 49

4.2 Cataract Surgery 51

4.2.1 Basic Technique 51

4.2.2 Principles of Phacoemulsification 52

4.2.3 Phacoemulsification Instruments 54

4.2.4 Phacoemulsification Systems 55

4.2.5 Future Directions 56

4.3 Vitreoretinal Surgery 56

4.3.1 Basic Techniques 56

4.3.2 Principles of Vitrectomy 57

4.3.3 Vitrectomy Instruments 58

4.3.4 Vitrectomy Systems 60

4.3.5 Future Directions 60

4.4 Other Ophthalmic Surgical Procedures 61

4.5 Conclusion 62

5. Surgical Robotics 63
Jacob Rosen

5.1 Introduction 63

5.2 Background and Leading Concepts 63

5.2.1 Human–Machine Interfaces: System Approach 65

5.2.2 Tissue Biomechanics 70

5.2.3 Teleoperation 72

5.2.4 Image-Guided Surgery 78

5.2.5 Objective Assessment of Skill 79

5.3 Commercial Systems 80

5.3.1 ROBODOC® (Curexo Technology Corporation) 80

5.3.2 daVinci (Intuitive Surgical) 83

5.3.3 Sensei® X (Hansen Medical) 84

5.3.4 RIO® MAKOplasty (MAKO Surgical Corporation) 86

5.3.5 CyberKnife (Accuray) 89

5.3.6 Renaissance™ (Mazor Robotics) 91

5.3.7 ARTAS® System (Restoration Robotics, Inc.) 92

5.4 Trends and Future Directions 93

6. Catheters in Vascular Therapy 99
Axel Boese

6.1 Introduction 99

6.2 Historic Overview 100

6.3 Catheter Interventions 102

6.4 Catheter and Guide Wire Shapes and Configurations 105

6.4.1 Catheters 105

6.4.2 Guide Wires 113

6.5 Conclusion 116

PART III ENERGY DELIVERY DEVICES AND SYSTEMS 119

7. Energy-Based Hemostatic Surgical Devices 121
Amit P. Mulgaonkar, Warren Grundfest, and Rahul Singh

7.1 Introduction 121

7.2 History of Energy-Based Hemostasis 122

7.3 Energy-Based Surgical Methods and Their Effects on Tissues 125

7.3.1 Disambiguation 126

7.3.2 Thermal Effects on Tissues 127

7.4 Electrosurgery 128

7.4.1 Electrosurgical Theory 128

7.4.2 Cutting and Coagulation Techniques 130

7.4.3 Equipment 131

7.4.4 Considerations and Complications 133

7.5 Future Of Electrosurgery 134

7.6 Conclusion 135

8. Tissue Ablation Systems 137
Michael Douek, Justin McWilliams, and David Lu

8.1 Introduction 137

8.2 Evolving Paradigms in Cancer Therapy 138

8.3 Basic Ablation Categories and Nomenclature 140

8.4 Hyperthermic Ablation 140

8.5 Fundamentals of In Vivo Energy Deposition 141

8.6 Hyperthermic Ablation: Optimizing Tissue Ablation 143

8.7 Radiofrequency Ablation 144

8.8 RFA: Basic Principles 145

8.9 RFA: In Vivo Energy Deposition 145

8.10 Optimizing RFA 147

8.11 Other Hyperthermic Ablation Techniques 149

8.11.1 Microwave Ablation (MWA) 149

8.11.2 MWA: Basic Principles 149

8.11.3 MWA: In Vivo Energy Deposition 151

8.11.4 Optimizing MWA 152

8.12 Laser Ablation 153

8.13 Hypothermic Ablation 154

8.13.1 Cryoablation: Basic Concepts 154

8.13.2 Cryoablation: In Vivo Considerations 154

8.13.3 Optimizing Cryoablation Systems 154

8.14 Chemical Ablation 157

8.15 Novel Techniques 158

8.15.1 High Intensity Focused Ultrasound (HIFU) 158

8.15.2 Irreversible Electroporation (IRE) 159

8.16 Tumor Ablation and Beyond 160

9. Lasers in Medicine 163
Zachary Taylor, Asael Papour, Oscar Stafsudd, and Warren Grundfest

9.1 Introduction 163

9.1.1 Historical Perspective 164

9.1.2 Basic Operational Concepts 165

9.1.3 First Experimental MASER (Microwave Amplification by Stimulated Emission of Radiation) 166

9.2 Laser Fundamentals 167

9.2.1 Two-Level Systems and Population Inversion 167

9.2.2 Multiple Energy Levels 167

9.2.3 Mode of Operation 169

9.2.4 Beams and Optics 171

9.3 Laser Light Compared to Other Sources of Light 174

9.3.1 Temporal Coherence 174

9.3.2 Spectral Coherence (Line Width) 175

9.3.3 Beam Collimation 177

9.3.4 Short Pulse Duration 177

9.3.5 Summary 178

9.4 Laser–Tissue Interactions 178

9.4.1 Biostimulation 178

9.4.2 Photochemical Interactions 179

9.4.3 Photothermal Interactions 180

9.4.4 Ablation 180

9.4.5 Photodisruption 181

9.5 Lasers in Diagnostics 181

9.5.1 Optical Coherence Tomography 181

9.5.2 Fluorescence Angiography 184

9.5.3 Near Infrared Spectroscopy 185

9.6 Laser Treatments and Therapy 186

9.6.1 Overview of Current Medical Applications of Laser Technology 186

9.6.2 Retinal Photodynamic Therapy (Photochemical) 188

9.6.3 Transpupillary Thermal Therapy (TTT) (Photothermal) 188

9.6.4 Vascular Birth Marks (Photocoagulation) 190

9.6.5 Laser Assisted Corneal Refractive Surgery (Ablation) 191

9.7 Conclusions 196

PART IV IMPLANTABLE DEVICES AND SYSTEMS 197

10. Vascular and Cardiovascular Devices 199
Dan Levi, Allan Tulloch, John Ho, Colin Kealey, and David Rigberg

10.1 Introduction 199

10.2 Biocompatibility Considerations 200

10.3 Materials 202

10.3.1 316L Stainless Steel 203

10.3.2 Nitinol 203

10.3.3 Cobalt–Chromium Alloys 204

10.4 Stents 204

10.5 Closure Devices 206

10.6 Transcatheter Heart Valves 208

10.7 Inferior Vena Cava Filters 212

10.8 Future Directions–Thin Film Nitinol 214

10.9 Conclusion 216

11. Mechanical Circulatory Support Devices 219
Colin Kealey, Paymon Rahgozar, and Murray Kwon

11.1 Introduction 219

11.2 History 220

11.3 Basic Principles 221

11.3.1 Biocompatibility and Mechanical Circulatory Support Devices 221

11.3.2 Hemocompatibility: Microscopic Considerations 222

11.3.3 Hemocompatibility: Macroscopic Considerations 223

11.4 Engineering Considerations in Mechanical Circulatory Support 223

11.4.1 Overview 223

11.4.2 Pump Design 225

11.4.3 Positive Displacement Pumps 225

11.4.4 Rotary Pumps 226

11.4.5 Pulsatile Versus Nonpulsatile Flow 228

11.5 Devices 228

11.5.1 The HeartMate XVE Left Ventricular Assist System 228

11.5.2 The HeartMate II Left Ventricular Assist System 231

11.5.3 Short-Term Mechanical Circulatory Support: The Intraaortic Balloon Pump 234

11.5.4 Pediatric Mechanical Circulatory Support: The Berlin Heart 237

11.6 The Future of MCS Devices 239

11.6.1 CorAide 239

11.6.2 HeartMate III 239

11.6.3 HeartWare 240

11.6.4 VentrAssist 240

11.7 Summary 240

12. Orthopedic Implants 241
Sophia N. Sangiorgio, Todd S. Johnson, Jon Moseley, G. Bryan Cornwall, and Edward Ebramzadeh

12.1 Introduction 241

12.1.1 Overview 241

12.1.2 History 243

12.2 Basic Principles 244

12.2.1 Optimization for Strength and Stiffness 245

12.2.2 Maximization of Implant Fixation to Host Bone 250

12.2.3 Minimization of Degradation 251

12.2.4 Sterilization of Implants and Instrumentation 253

12.3 Implant Technologies 253

12.3.1 Total Hip Replacement 254

12.3.2 Technology in Total Knee Replacement 263

12.3.3 Technology in Spine Surgery 268

12.4 Summary 272

PART V IMAGING AND IMAGE-GUIDED TECHNIQUES 275

13. Endoscopy 277
Gregory Nighswonger

13.1 Introduction 277

13.2 Ancient Origins 278

13.3 Modern Endoscopy 280

13.3.1 Creating Cold Light 280

13.3.2 Introduction of Rod-Lens Technology 280

13.4 Principles of Modern Endoscopy 283

13.4.1 Optics 284

13.4.2 Mechanics 284

13.4.3 Electronics 284

13.4.4 Software 285

13.5 The Imaging Chain 285

13.5.1 Light Source (1) 286

13.5.2 Telescope (2) 286

13.5.3 Camera Head (3) 287

13.5.4 Camera CCU (4) 287

13.5.5 Video Cables (5) 287

13.5.6 Monitor (6) 287

13.5.7 Image Management Systems (7) 288

13.6 Endoscopes for Today 288

13.6.1 Rigid Endoscopes—Designs to Enhance Functionality 289

13.6.2 Less Traumatic Ureterorenoscopes 290

13.6.3 Advances in Flexible Endoscope Design 291

13.6.4 Broader Functionality with New Technologies 294

13.6.5 Enhancing Video Capabilities 299

13.7 Endoscopy’s Future 301

14. Medical Ultrasound Devices 303
Rahul Singh and Martin Culjat

14.1 Introduction 303

14.2 Basic Principles of Ultrasound 304

14.2.1 Basic Acoustic Physics 304

14.2.2 Reflection and Refraction 307

14.2.3 Attenuation 307

14.2.4 Piezoelectricity 308

14.2.5 Ultrasound Systems 310

14.2.6 Resolution and Bandwidth 312

14.2.7 Beam Characteristics 314

14.3 Ultrasound Transducer Design 316

14.3.1 Piezoelectric Material 317

14.3.2 Backing Layers and Damping 318

14.3.3 Matching Layers 318

14.3.4 Mechanical Focusing 319

14.3.5 Electrical Matching 320

14.3.6 Sector Scanners 320

14.3.7 Array Transducers 322

14.3.8 Transducer Array Fabrication 325

14.3.9 Regulatory Considerations 327

14.4 Applications of Medical Ultrasound 329

14.4.1 Image Guidance Applications 330

14.4.2 Intravascular and Intracardiac Applications 332

14.4.3 Intraoral and Endocavity Applications 333

14.4.4 Surgical Applications 334

14.4.5 Ophthalmic Ultrasound 335

14.4.6 Doppler and Doppler Applications 336

14.4.7 Therapeutic Applications 336

14.5 The Future of Medical Ultrasound 338

15. Medical X-ray Imaging 341
Mark Roden

15.1 Introduction 341

15.2 X-ray Physics 342

15.2.1 Photon Interactions with Matter 342

15.2.2 Clinical Production of X-rays 343

15.2.3 Patient Dose Considerations 346

15.3 Two-Dimensional Image Acquisition 348

15.4 Image Acquisition Technologies and Techniques 351

15.4.1 Film 351

15.4.2 Computed Radiography 354

15.4.3 Digital Radiography 358

15.4.4 Clinical Applications of 2D X-ray Techniques 360

15.5 Basic 2D Processing Techniques 361

15.5.1 Independent Pixel Operations 362

15.5.2 Grouped Pixel Operations 363

15.5.3 Image Transformation Operations 366

15.6 Real-Time X-ray Imaging 367

15.6.1 Fluoroscopy Technology 367

15.6.2 Angiography 370

15.7 Three-Dimensional X-ray Imaging 372

15.8 Conclusion 373

16. Navigation in Neurosurgery 375
Jean-Jacques Lemaire, Eric J. Behnke, Andrew J. Frew, and Antonio A. F. DeSalles

16.1 Basics of Neurosurgery 375

16.1.1 General Technical Issues in Neurosurgery 375

16.1.2 Instrumentation in Neurosurgery 376

16.1.3 Complications 377

16.1.4 Functional Neurosurgery 378

16.1.5 Stereotactic Neurosurgery 378

16.1.6 Neuroimaging for Neurosurgery 379

16.2 Introduction to Neuronavigation 381

16.3 Neuronavigation Systems 381

16.3.1 The Tracking System 382

16.3.2 The Display Unit 383

16.3.3 The Control Unit 385

16.4 Implementation of Neuronavigation 386

16.4.1 Surgical Planning 386

16.4.2 Patient Registration 387

16.4.3 Navigation 389

16.5 Augmented Reality and Virtual Reality 390

16.6 Summary/Future 391

REFERENCES 395

INDEX 425