Main description:

Addressing the exploding interest in bioengineering for healthcare applications, this book provides readers with detailed yet easy-to-understand guidance on biomedical device engineering. Written by prominent physicians and engineers, Medical Devices: Surgical and Image-Guided Technologies is organized into stand-alone chapters covering devices and systems in diagnostic, surgical, and implant procedures. Assuming only basic background in math and science, the authors clearly explain the fundamentals for different systems along with such topics as engineering considerations, therapeutic techniques and applications, future trends, and more.
After describing how to manage a design project for medical devices, the book examines the following: Instruments for laparoscopic and ophthalmic surgery, plus surgical robotics Catheters in vascular therapy and energy-based hemostatic surgical devices Tissue ablation systems and the varied uses of lasers in medicine Vascular and cardiovascular devices, plus circulatory support devices Ultrasound transducers, X-ray imaging, and neuronavigation An absolute must for biomedical engineers, Medical Devices: Surgical and Image-Guided Technologies is also an invaluable guide for students in all engineering majors and pre-med programs interested in exploring this fascinating field.

Contents:

PREFACE xvii 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(r) (Curexo Technology Corporation) 80 5.3.2 daVinci (Intuitive Surgical) 83 5.3.3 Sensei(r) X (Hansen Medical) 84 5.3.4 RIO(r) MAKOplasty (MAKO Surgical Corporation) 86 5.3.5 CyberKnife (Accuray) 89 5.3.6 Renaissance(t); (Mazor Robotics) 91 5.3.7 ARTAS(r) 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