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Medical Devices
Surgical and Image–Guided Technologies
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Main description:

A comprehensive introduction to biomedical device engineering


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.


Back cover:

A comprehensive introduction to biomedical device engineering


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 Team16


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 ErikDutson


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–PierreHubschman


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 Tissues125


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 WarrenGrundfest


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 byStimulated 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 LaserTechnology 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 DavidRigberg


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 SupportDevices 221


11.3.2 Hemocompatibility: Microscopic Considerations 222


11.3.3 Hemocompatibility: Macroscopic Considerations 223


11.4 Engineering Considerations in Mechanical CirculatorySupport 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: TheIntraaortic Balloon Pump 234


11.5.4 Pediatric Mechanical Circulatory Support: The BerlinHeart 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. BryanCornwall, 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 Functionality289


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, andAntonio 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


PRODUCT DETAILS

ISBN-13: 9781118453537
Publisher: John Wiley & Sons Ltd (Wiley–Blackwell)
Publication date: December, 2012
Pages: 456

Subcategories: Diseases and Disorders

MEET THE AUTHOR

MARTIN CULJAT, PhD, is Adjunct Assistant Professor in theUCLA Departments of Bioengineering and Surgery and the EngineeringResearch Director of the UCLA Center for Advanced Surgical andInterventional Technology (CASIT), a research center that promotescollaboration between medicine and engineering.


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


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