Medical Device Technologies: A Systems Based Overview Using Engineering Standards, Second Edition, is a comprehensive overview of medical device technology, with a unified approach to each device area covering technical operation, clinical need, regulatory issues and standards and historical devices. It takes a systems-based view, balancing breadth with depth to give an accessible introduction to this field. Close ties are drawn between the design, the product and the patient. Exercises at the end of each chapter include traditional homework problems, analysis exercises and four questions from assigned primary literature. Eight laboratory experiments in both electrical and mechanical medical devices are explored.
Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. This systems approach enables the reader to quickly identify the relationships between devices. An accompanying instructor site containing answers to end of chapter exercises, image collections, datasets and solutions for the lab experiments is also included.
Author(s): Gail Baura
Edition: 2
Publisher: Academic Press
Year: 2020
Language: English
Pages: 622
City: London
Introduction
Chapter 1 - Diagnosis and therapy
Chapter outline
Medical device definitions
Clinical need
Medical devices versus medical instruments
Instruments make measurements
Input dynamic range and frequency response
Accuracy, bias, and precision
Noise sources
Sensors
Surface electrodes
Pressure sensors
Thermistors
Photodiodes
Patient and operator safety
Leakage current
Defibrillation protection
Amplification
Operational amplifiers
Biopotential amplifiers
Data acquisition
Nyquist sampling theorem
Medical electrical stimulators
Stimulator batteries
Systems
Summary
Acknowledgment
References
Chapter 2 - Electrocardiographs
Chapter outline
Cardiac electrical conduction
Cardiac anatomy
Spread of action potentials
Standard leads
Two arrhythmia classes
Irregular rhythms
Escape
Clinical need
Historic devices
Early devices
Enabling technology: string galvanometer
System description and diagram
Arrhythmia detection accuracy
Key features from engineering standards
Input dynamic range
Frequency response
System noise level
Arrhythmia detection
Leads-off detection
Summary
Exercises
References
Chapter 3 - Pacemakers
Chapter outline
Two arrhythmia classes
Premature beats
Heart block
Heart failure
Tissue response to stimulation voltage
Clinical need
Historic devices
Early devices
Enabling technology: Ruben-Mallory zinc mercuric oxide battery
System description and diagram
Leads
Pulse generator
Capture tests
Pacemaker sensing parameters and modes
Cardiac resynchronization therapy
Pacemaker programmer
Remote monitor
Key features from engineering standards
Lead connection
Mechanical integrity of leads
Battery
Sensitivity
Minimum susceptibility to electromagnetic interference
Temporary cardiac pacing
Summary
Acknowledgment
Exercises
References
Chapter 4 - External defibrillators
Chapter outline
Tachyarrhythmias
Paroxysmal Tachycardia
Flutter
Fibrillation
Sudden cardiac arrest and cardiopulmonary resuscitation
Defibrillation mechanism and threshold
Clinical need
Historic devices
Early external defibrillator devices
Enabling technology: Lown-Edmark waveform
Early automated external defibrillator devices
Enabling technology: biphasic truncated exponential waveform
System description and diagram
Thoracic impedance
Key features from engineering standards
Battery charging time
Capacitor discharge accuracy
Synchronization
Rhythm recognition detection accuracy
Recovery after defibrillation
Summary
Exercises
References
Chapter 5 - Implantable cardioverter defibrillators
Chapter outline
Wound-healing response
Pulse generator biocompatibility
Clinical need
Historic devices
Early devices
Enabling technologies: transvenous defibrillation and integrated leads
System description and diagram
Defibrillation threshold tests
Arrhythmia detection
Key features from engineering standards
Biologic effects
Mechanical integrity of leads
Delivered voltage and energy
Battery discharge and warning
Arrhythmia detection accuracy
FDA case study: Guidant ICD recall
Public Guidant actions
Internal Guidant actions
FDA responses
Aftermath
Summary
Acknowledgment
Exercises
References
Chapter 6 - Heart valves
Chapter outline
Cardiac mechanics
Cardiac cycle
Fluid mechanics
Blood coagulation
Mechanical valve biocompatibility
Clinical need
Historic devices
Early devices
Enabling technology: ball and cage valve
Enabling technology: glutaraldehyde treatment
Enabling technology: transcatheter valve
System description and diagram
Comparison of velocities and turbulent shear stresses
FDA case study: Bjork-Shiley heart valve
Public Shiley actions
Internal Shiley actions
FDA responses
Aftermath
Key features from engineering standards
Hydrodynamic performance
Component fatigue
One-year clinical study
Clinical study long-term follow-up
Biocompatibility
Summary
Acknowledgment
Exercises
References
Chapter 7 - Blood pressure monitors
Chapter outline
Blood pressure propagation
Vital signs
Clinical need
Historic devices
Early devices
Enabling technology: auscultation
Enabling technology: oscillometry
System descriptions and diagrams
Measurement equivalency
Consumer blood pressure monitor accuracy
Key features from engineering standards
Monitor life
Monitor cuff pressures
Monitor accuracy with auscultatory method as reference standard
Monitor accuracy with intraarterial method as reference standard
Transducer accuracy
Summary
Exercises
References
Chapter 8 - Catheters, bare metal stents, and synthetic grafts
Chapter outline
Atherosclerosis
Percutaneous coronary interventions
Aneurysms
Clinical need
Historic devices
Early devices
Enabling technology: percutaneous transluminal coronary angioplasty
Enabling technology: Vinyon “N” cloth
System descriptions and diagrams
Cardiac catheterization procedures
Angiography
Angioplasty
Blood pressure monitoring
Thermodilution
Electrophysiologic studies and ablation
Biopsy
Transcatheter valve delivery
Bare metal stents
Synthetic grafts
FDA case study: Guidant Ancure endovascular graft system
Public Guidant actions
Internal Guidant actions
FDA responses
Aftermath
Key features from engineering standards
Balloon rated burst pressure
Elastic recoil
Microscopic porosity
Biocompatibility
In vivo clinical study
Summary
Exercises
References
Chapter 9 - Hemodialysis delivery systems
Chapter outline
Body fluid compartments
Renal anatomy and physiology
Urine formation
Regulation of water and electrolyte balances
Renal replacement therapies
Dialysis adequacy through urea modeling
Clinical need
Historic devices
Early devices
Enabling technology: external arteriovenous fistula
System description and diagram
Hemodialyzers
Hemodialysis delivery systems
Key features from engineering standards
Hemodialyzer clearance
Blood circuit air protection
Temperature monitoring
Ultrafiltration control system
Blood leak detection
Summary
Acknowledgment
Exercises
References
Chapter 10 - Mechanical ventilators
Chapter outline
Pulmonary physiology
Pulmonary blood flow
Pulmonary ventilation
Gas diffusion
Ventilator mechanics
Clinical need
Historic devices
Early devices
Enabling technology: positive-pressure ventilation
System description and diagram
Common modes of mechanical ventilation
Noninvasive ventilation
Key features from engineering standards
Protection from interruption of power supply
Maximum pressure to patient
Accuracy for pressure-controlled breath type
Oxygen monitor
Protection from breathing system leakage
Summary
Exercises
References
Chapter 11 - Pulse oximeters
Chapter outline
Oxygen transport in blood
Hemoglobin
Oxyhemoglobin dissociation curve
Carbon monoxide displacement
Beer-Lambert law
Adaptive filtering
Clinical need
Historic devices
Early devices
Enabling technology: calibration curve
Enabling technology: adaptive filtering
System description and diagram
Home pulse oximeters
Key features from engineering standards
SpO2 accuracy
Accuracy under conditions of motion
Accuracy under conditions of low perfusion
Signal inadequacy indication
Protection from excessive temperatures
Respiration monitors
Summary
Exercises
References
Chapter 12 - Thermometers
Chapter outline
Thermoregulation physiology
Mechanisms of heat loss
Thermoregulation anatomy
Thermoregulation
Skin temperature versus core temperature
Clinical need
Historic devices
Early Devices
Enabling technology: six-inch mercury thermometer
System descriptions and diagrams
Simple thermometer
Digital electronic thermometer
Infrared thermometer
Key features from engineering standards
Electronic thermometer accuracy
Maximum permissible laboratory error for ear IR thermometer
Maximum permissible laboratory error for skin IR thermometer
IR thermometer clinical accuracy
Probe cover physical integrity
FDA consensus standards for accuracy
Summary
Acknowledgment
Exercises
References
Chapter 13 - Electroencephalographs
Chapter outline
Brain physiology
Neural current flow
Generation of electroencephalograms
Original 10-20 system
EEG electrodes
Montages
Analysis
Clinical need
Epilepsy
Sleep disorders
Historic devices
Early devices
Enabling technology: double-coil galvanometer
System description and diagram
Key features from engineering standards
Electrostatic discharge prevention
Frequency response
Bispectral index monitors
Summary
Exercises
References
Chapter 14 - Deep brain stimulators
Chapter outline
Basal ganglia
Parkinson’s disease
Levodopa therapy
Target localization
Clinical need
Historic devices
Early devices
Enabling technology: replacement of ablation by stimulation
System description and diagram
Leads
Implantable pulse generator
Programmers
Closed-loop control
Key features from engineering standards
Stimulation pulse characteristics
Battery indication
Biologic effects
Immunity from electromagnetic interference
Protection from harm caused by magnetically-induced force
Summary
Acknowledgment
Exercises
References
Chapter 15 - Cochlear implants
Chapter outline
Auditory physiology
Hearing
Sensorineural hearing loss
Speech processing
Clinical need
Historic devices
Early implantable devices
Enabling technology: continuous interleaved sampling speech processing strategy
System description and diagram
Processor
Implant
Electrode array
Programmer
Improvements in sound recognition
Key features from engineering standards
Output amplitude
Protection from harm caused by magnetically-induced force
Effect of tensile forces
Effect of direct impact
Effect of atmospheric pressure
Summary
Acknowledgment
Exercises
References
Chapter 16 - Functional electrical stimulators
Chapter outline
Spinal nerves
Neuromuscular junction
Spinal cord injury
Electrical stimulation
Neural interface systems
Clinical need
Historic devices
Early devices
Freehand neurostimulator
BrainGate system
Emerging technologies
Functional electrical stimulation and intracortical brain–computer interface
FES + iBCI issues
Robotic exoskeleton
Key features from engineering standards
Summary
Acknowledgment
Exercises
References
Chapter 17 - Intraocular lens implants
Chapter outline
Ocular physiology
Vision
Cataracts
Ultrasound
A-scan biometry
Emulsification
Clinical need
Historic devices
Early devices
Enabling technology: poly(methyl methacrylate) lens
Enabling technology: phacoemulsification
System description and diagram
Intraocular lens designs
Intraocular lens complications
Other intraocular lenses
Key features from engineering standards
Dynamic fatigue durability
Recovery of properties following simulated surgical manipulation
Hydrolytic stability
Effect of Nd-YAG laser exposure
Clinical study
Summary
Acknowledgment
Exercises
References
Chapter 18 - Total hip prostheses
Chapter outline
Hip physiology
Bone
Articular cartilage and synovial joint capsule
Contact forces
Biotribology
Wear-mediated osteolysis
Clinical need
Historic devices
Early devices
Enabling technologies: low friction and PMMA cement
System descriptions and diagrams
Bearings and wear
Hip resurfacing
Key features from engineering standards
Femoral component fatigue without torsion
Femoral component fatigue with torsion
Femoral component corrosion
Wear: test apparatus
Wear: test measurements
FDA regulation
Summary
Acknowledgment
Exercises
References
Chapter 19 - Drug-eluting stents
Chapter outline
Combination products
Drug delivery using coatings
Clinical need
Engineering design
Drug-eluting stent requirements
System descriptions and diagrams
First generation
Second generation
Third generation
Key features from engineering standards
Pre-clinical in vitro evaluation of the device part-related attributes
Summary
Acknowledgment
Exercises
References
Chapter 20 - Artificial pancreas
Chapter outline
Blood glucose regulation
Pancreatic hormones
Hormonal control
Diabetes mellitus
Compartmental models
Model identifiability
Minimal model of insulin sensitivity
Plasma interstitial glucose equilibration model
Clinical need
Historic devices
Ideal artificial pancreas system
Early devices
Artificial pancreas requirements
Sensor performance
Closed-loop control
System description and diagram
Key features from engineering standards
Sensor point accuracy
Sensor trend accuracy
Sensor threshold alarm accuracy
Sensor stability
Summary
Acknowledgment
Exercises
References
21 - ECG electrode verification testing lab
Chapter outline
Strategic planning
Materials and methods
Procedure
Results and analysis
Discussion
Reference
Chapter 22 - Electrocardiograph design lab
Chapter outline
Strategic planning
Materials and methods
Procedure
Results and analysis
Discussion
Reference
Chapter 23 - Electrocardiograph filtering lab
Chapter Outline
Strategic planning
Introduction to wavelet filters
Materials and methods
Procedure
Results and analysis
Discussion
References
Chapter 24 - Pacemaker programming lab
Chapter ouline
Strategic planning
Materials and methods
Patient 1
Patient 2
Patient 3
Results and analysis
Discussion
Chapter 25 - Echocardiography lab
Chapter outline
Strategic planning
Materials and methods
Background
Measurements
Procedure
Results and analysis
Discussion
References
Chapter 26 - Patient monitoring lab
Chapter outline
Strategic planning
Patient monitoring
Motion artifact and false alarms
Materials and methods
Procedure
Results and analysis
Discussion
References
Chapter 27 - Thermometry accuracy lab
Chapter outline
Strategic planning
Materials and methods
Procedure
Results and analysis
Discussion
References
Chapter 28 - Energy balance lab
Chapter outline
Strategic planning
Personal comfort in a building
Radiant cloud convection
Radiant cloud radiation
Radiation calculated from energy balance of the entire system
Materials and methods
Procedure
Radiant cloud efficiency
Results and analysis
Discussion
Acknowledgments
Reference
Chapter 29 - Surface characterization lab
Chapter outline
Strategic planning
Medical device coatings
Surface modification
Materials and methods
Procedure
Results and analysis
Discussion
Acknowledgment
References
Chapter 30 - Entrepreneurship lab
Chapter outline
Strategic planning
Required readings
Crossing the Chasm background
Materials and methods
Report structure and grading
Crossing the Chasm discussion lecture
References
Chapter 31 - Engineering ethics lab
Chapter outline
Strategic planning
Required readings
Engineering ethics background
Materials and methods
Assignment structure and grading
References
