medical devices and sistems

The Biomedical Engineering HandbookThird Edition

Medical Devicesand Systems

© 2006 by Taylor & Francis Group, LLC

The Electrical Engineering Handbook Series

Series Editor

Richard C. DorfUniversity of California, Davis

Titles Included in the Series

The Handbook of Ad Hoc Wireless Networks, Mohammad IlyasThe Avionics Handbook, Cary R. SpitzerThe Biomedical Engineering Handbook, Third Edition, Joseph D. BronzinoThe Circuits and Filters Handbook, Second Edition, Wai-Kai ChenThe Communications Handbook, Second Edition, Jerry GibsonThe Computer Engineering Handbook, Vojin G. OklobdzijaThe Control Handbook, William S. LevineThe CRC Handbook of Engineering Tables, Richard C. DorfThe Digital Signal Processing Handbook, Vijay K. Madisetti and Douglas WilliamsThe Electrical Engineering Handbook, Third Edition, Richard C. DorfThe Electric Power Engineering Handbook, Leo L. GrigsbyThe Electronics Handbook, Second Edition, Jerry C. WhitakerThe Engineering Handbook, Third Edition, Richard C. DorfThe Handbook of Formulas and Tables for Signal Processing, Alexander D. PoularikasThe Handbook of Nanoscience, Engineering, and Technology, William A. Goddard, III,

Donald W. Brenner, Sergey E. Lyshevski, and Gerald J. IafrateThe Handbook of Optical Communication Networks, Mohammad Ilyas and

Hussein T. MouftahThe Industrial Electronics Handbook, J. David IrwinThe Measurement, Instrumentation, and Sensors Handbook, John G. WebsterThe Mechanical Systems Design Handbook, Osita D.I. Nwokah and Yidirim HurmuzluThe Mechatronics Handbook, Robert H. BishopThe Mobile Communications Handbook, Second Edition, Jerry D. GibsonThe Ocean Engineering Handbook, Ferial El-HawaryThe RF and Microwave Handbook, Mike GolioThe Technology Management Handbook, Richard C. DorfThe Transforms and Applications Handbook, Second Edition, Alexander D. PoularikasThe VLSI Handbook, Wai-Kai Chen



Edited byJoseph D. Bronzino

Biomedical Engineering Fundamentals

Medical Devices and Systems

Tissue Engineering and Artificial Organs



Medical Devicesand Systems

Edited by

Joseph D. BronzinoTrinity College

Hartford, Connecticut, U.S.A.

A CRC title, part of the Taylor & Francis imprint, a member of theTaylor & Francis Group, the academic division of T&F Informa plc.

Boca Raton London New York


Published in 2006 byCRC PressTaylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300Boca Raton, FL 33487-2742

© 2006 by Taylor & Francis Group, LLCCRC Press is an imprint of Taylor & Francis Group

No claim to original U.S. Government worksPrinted in the United States of America on acid-free paper10 9 8 7 6 5 4 3 2 1

International Standard Book Number-10: 0-8493-2122-0 (Hardcover) International Standard Book Number-13: 978-0-8493-2122-1 (Hardcover) Library of Congress Card Number 2005056892

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Library of Congress Cataloging-in-Publication Data

Medical devices and systems / edited by Joseph D. Bronzino.p. cm. -- (The electrical engineering handbook series)

Includes bibliographical references and index.ISBN 0-8493-2122-01. Medical instruments and apparatus--Handbooks, manuals, etc. I. Bronzino, Joseph D., 1937- II.

Title. III. Series.

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Introduction and Preface

During the past five years since the publication of the Second Edition — a two-volume set — of theBiomedical Engineering Handbook, the field of biomedical engineering has continued to evolve and expand.As a result, this Third Edition consists of a three volume set, which has been significantly modified toreflect the state-of-the-field knowledge and applications in this important discipline. More specifically,this Third Edition contains a number of completely new sections, including:

• Molecular Biology• Bionanotechnology• Bioinformatics• Neuroengineering• Infrared Imaging

as well as a new section on ethics.In addition, all of the sections that have appeared in the first and second editions have been significantly

revised. Therefore, this Third Edition presents an excellent summary of the status of knowledge andactivities of biomedical engineers in the beginning of the 21st century.

As such, it can serve as an excellent reference for individuals interested not only in a review of funda-mental physiology, but also in quickly being brought up to speed in certain areas of biomedical engineeringresearch. It can serve as an excellent textbook for students in areas where traditional textbooks have notyet been developed and as an excellent review of the major areas of activity in each biomedical engineeringsubdiscipline, such as biomechanics, biomaterials, bioinstrumentation, medical imaging, etc. Finally, itcan serve as the“bible” for practicing biomedical engineering professionals by covering such topics as a his-torical perspective of medical technology, the role of professional societies, the ethical issues associatedwith medical technology, and the FDA process.

Biomedical engineering is now an important vital interdisciplinary field. Biomedical engineers areinvolved in virtually all aspects of developing new medical technology. They are involved in the design,development, and utilization of materials, devices (such as pacemakers, lithotripsy, etc.) and techniques(such as signal processing, artificial intelligence, etc.) for clinical research and use; and serve as membersof the health care delivery team (clinical engineering, medical informatics, rehabilitation engineering,etc.) seeking new solutions for difficult health care problems confronting our society. To meet the needsof this diverse body of biomedical engineers, this handbook provides a central core of knowledge in thosefields encompassed by the discipline. However, before presenting this detailed information, it is importantto provide a sense of the evolution of the modern health care system and identify the diverse activitiesbiomedical engineers perform to assist in the diagnosis and treatment of patients.

Evolution of the Modern Health Care SystemBefore 1900, medicine had little to offer the average citizen, since its resources consisted mainly ofthe physician, his education, and his “little black bag.” In general, physicians seemed to be in short


supply, but the shortage had rather different causes than the current crisis in the availability of healthcare professionals. Although the costs of obtaining medical training were relatively low, the demand fordoctors’ services also was very small, since many of the services provided by the physician also could beobtained from experienced amateurs in the community. The home was typically the site for treatmentand recuperation, and relatives and neighbors constituted an able and willing nursing staff. Babies weredelivered by midwives, and those illnesses not cured by home remedies were left to run their natural,albeit frequently fatal, course. The contrast with contemporary health care practices, in which specializedphysicians and nurses located within the hospital provide critical diagnostic and treatment services, isdramatic.

The changes that have occurred within medical science originated in the rapid developments that tookplace in the applied sciences (chemistry, physics, engineering, microbiology, physiology, pharmacology,etc.) at the turn of the century. This process of development was characterized by intense interdis-ciplinary cross-fertilization, which provided an environment in which medical research was able totake giant strides in developing techniques for the diagnosis and treatment of disease. For example,in 1903, Willem Einthoven, a Dutch physiologist, devised the first electrocardiograph to measure theelectrical activity of the heart. In applying discoveries in the physical sciences to the analysis of thebiologic process, he initiated a new age in both cardiovascular medicine and electrical measurementtechniques.

New discoveries in medical sciences followed one another like intermediates in a chain reaction. How-ever, the most significant innovation for clinical medicine was the development of x-rays. These “newkinds of rays,” as their discoverer W.K. Roentgen described them in 1895, opened the “inner man” tomedical inspection. Initially, x-rays were used to diagnose bone fractures and dislocations, and in the pro-cess, x-ray machines became commonplace in most urban hospitals. Separate departments of radiologywere established, and their influence spread to other departments throughout the hospital. By the 1930s,x-ray visualization of practically all organ systems of the body had been made possible through the use ofbarium salts and a wide variety of radiopaque materials.

X-ray technology gave physicians a powerful tool that, for the first time, permitted accurate diagnosisof a wide variety of diseases and injuries. Moreover, since x-ray machines were too cumbersome andexpensive for local doctors and clinics, they had to be placed in health care centers or hospitals. Oncethere, x-ray technology essentially triggered the transformation of the hospital from a passive receptaclefor the sick to an active curative institution for all members of society.

For economic reasons, the centralization of health care services became essential because of many otherimportant technological innovations appearing on the medical scene. However, hospitals remained insti-tutions to dread, and it was not until the introduction of sulfanilamide in the mid-1930s and penicillin inthe early 1940s that the main danger of hospitalization, that is, cross-infection among patients, was signi-ficantly reduced. With these new drugs in their arsenals, surgeons were able to perform their operationswithout prohibitive morbidity and mortality due to infection. Furthermore, even though the differentblood groups and their incompatibility were discovered in 1900 and sodium citrate was used in 1913 toprevent clotting, full development of blood banks was not practical until the 1930s, when technologyprovided adequate refrigeration. Until that time, “fresh” donors were bled and the blood transfused whileit was still warm.

Once these surgical suites were established, the employment of specifically designed pieces of med-ical technology assisted in further advancing the development of complex surgical procedures. Forexample, the Drinker respirator was introduced in 1927 and the first heart-lung bypass in 1939. Bythe 1940s, medical procedures heavily dependent on medical technology, such as cardiac catheterizationand angiography (the use of a cannula threaded through an arm vein and into the heart with the injectionof radiopaque dye) for the x-ray visualization of congenital and acquired heart disease (mainly valvedisorders due to rheumatic fever) became possible, and a new era of cardiac and vascular surgery wasestablished.

Following World War II, technological advances were spurred on by efforts to develop superior weaponsystems and establish habitats in space and on the ocean floor. As a by-product of these efforts, the


development of medical devices accelerated and the medical profession benefited greatly from this rapidsurge of technological finds. Consider the following examples:

1. Advances in solid-state electronics made it possible to map the subtle behavior of the fundamentalunit of the central nervous system — the neuron — as well as to monitor the various physiologicalparameters, such as the electrocardiogram, of patients in intensive care units.

2. New prosthetic devices became a goal of engineers involved in providing the disabled with tools toimprove their quality of life.

3. Nuclear medicine — an outgrowth of the atomic age — emerged as a powerful and effectiveapproach in detecting and treating specific physiologic abnormalities.

4. Diagnostic ultrasound based on sonar technology became so widely accepted that ultrasonic studiesare now part of the routine diagnostic workup in many medical specialties.

5. “Spare parts” surgery also became commonplace. Technologists were encouraged to providecardiac assist devices, such as artificial heart valves and artificial blood vessels, and the artifi-cial heart program was launched to develop a replacement for a defective or diseased humanheart.

6. Advances in materials have made the development of disposable medical devices, such as needlesand thermometers, as well as implantable drug delivery systems, a reality.

7. Computers similar to those developed to control the flight plans of the Apollo capsule were usedto store, process, and cross-check medical records, to monitor patient status in intensive care units,and to provide sophisticated statistical diagnoses of potential diseases correlated with specific setsof patient symptoms.

8. Development of the first computer-based medical instrument, the computerized axial tomographyscanner, revolutionized clinical approaches to noninvasive diagnostic imaging procedures, whichnow include magnetic resonance imaging and positron emission tomography as well.

9. A wide variety of new cardiovascular technologies including implantable defibrillators andchemically treated stents were developed.

10. Neuronal pacing systems were used to detect and prevent epileptic seizures.11. Artificial organs and tissue have been created.12. The completion of the genome project has stimulated the search for new biological markers and

personalized medicine.

The impact of these discoveries and many others has been profound. The health care system of todayconsists of technologically sophisticated clinical staff operating primarily in modern hospitals designedto accommodate the new medical technology. This evolutionary process continues, with advances in thephysical sciences such as materials and nanotechnology, and in the life sciences such as molecular biology,the genome project and artificial organs. These advances have altered and will continue to alter the verynature of the health care delivery system itself.

Biomedical Engineering: A DefinitionBioengineering is usually defined as a basic research-oriented activity closely related to biotechnology andgenetic engineering, that is, the modification of animal or plant cells, or parts of cells, to improve plantsor animals or to develop new microorganisms for beneficial ends. In the food industry, for example, thishas meant the improvement of strains of yeast for fermentation. In agriculture, bioengineers may beconcerned with the improvement of crop yields by treatment of plants with organisms to reduce frostdamage. It is clear that bioengineers of the future will have a tremendous impact on the qualities ofhuman life. The potential of this specialty is difficult to imagine. Consider the following activities ofbioengineers:

• Development of improved species of plants and animals for food production• Invention of new medical diagnostic tests for diseases


The world of biomedical engineering

Biomechanics

Medical &biological analysis

Biosensors

Clinicalengineering

Medical &bioinformatics

Rehabilitationengineering

Physiologicalmodeling

Bionanotechnology

Biomedicalinstrumentation

Neuralengineering

Tissue engineering

Biotechnology

Biomaterials

Medical imaging

Prosthetic devices& artificial organs

FIGURE 1 The World of Biomedical Engineering.

• Production of synthetic vaccines from clone cells• Bioenvironmental engineering to protect human, animal, and plant life from toxicants and

pollutants• Study of protein–surface interactions• Modeling of the growth kinetics of yeast and hybridoma cells• Research in immobilized enzyme technology• Development of therapeutic proteins and monoclonal antibodies

Biomedical engineers, on the other hand, apply electrical, mechanical, chemical, optical, and otherengineering principles to understand, modify, or control biologic (i.e., human and animal) systems, aswell as design and manufacture products that can monitor physiologic functions and assist in the diagnosisand treatment of patients. When biomedical engineers work within a hospital or clinic, they are moreproperly called clinical engineers.

Activities of Biomedical EngineersThe breadth of activity of biomedical engineers is now significant. The field has moved from beingconcerned primarily with the development of medical instruments in the 1950s and 1960s to include amore wide-ranging set of activities. As illustrated below, the field of biomedical engineering now includesmany new career areas (see Figure 1), each of which is presented in this handbook. These areas include:

• Application of engineering system analysis (physiologic modeling, simulation, and control) tobiologic problems• Detection, measurement, and monitoring of physiologic signals (i.e., biosensors and biomedical

instrumentation)• Diagnostic interpretation via signal-processing techniques of bioelectric data• Therapeutic and rehabilitation procedures and devices (rehabilitation engineering)• Devices for replacement or augmentation of bodily functions (artificial organs)


• Computer analysis of patient-related data and clinical decision making (i.e., medical informaticsand artificial intelligence)• Medical imaging, that is, the graphic display of anatomic detail or physiologic function• The creation of new biologic products (i.e., biotechnology and tissue engineering)• The development of new materials to be used within the body (biomaterials)

Typical pursuits of biomedical engineers, therefore, include:

• Research in new materials for implanted artificial organs• Development of new diagnostic instruments for blood analysis• Computer modeling of the function of the human heart• Writing software for analysis of medical research data• Analysis of medical device hazards for safety and efficacy• Development of new diagnostic imaging systems• Design of telemetry systems for patient monitoring• Design of biomedical sensors for measurement of human physiologic systems variables• Development of expert systems for diagnosis of disease• Design of closed-loop control systems for drug administration• Modeling of the physiological systems of the human body• Design of instrumentation for sports medicine• Development of new dental materials• Design of communication aids for the handicapped• Study of pulmonary fluid dynamics• Study of the biomechanics of the human body• Development of material to be used as replacement for human skin

Biomedical engineering, then, is an interdisciplinary branch of engineering that ranges from theoretical,nonexperimental undertakings to state-of-the-art applications. It can encompass research, development,implementation, and operation. Accordingly, like medical practice itself, it is unlikely that any singleperson can acquire expertise that encompasses the entire field. Yet, because of the interdisciplinary natureof this activity, there is considerable interplay and overlapping of interest and effort between them.For example, biomedical engineers engaged in the development of biosensors may interact with thoseinterested in prosthetic devices to develop a means to detect and use the same bioelectric signal to powera prosthetic device. Those engaged in automating the clinical chemistry laboratory may collaborate withthose developing expert systems to assist clinicians in making decisions based on specific laboratory data.The possibilities are endless.

Perhaps a greater potential benefit occurring from the use of biomedical engineering is identificationof the problems and needs of our present health care system that can be solved using existing engineeringtechnology and systems methodology. Consequently, the field of biomedical engineering offers hope inthe continuing battle to provide high-quality care at a reasonable cost. If properly directed toward solvingproblems related to preventive medical approaches, ambulatory care services, and the like, biomedicalengineers can provide the tools and techniques to make our health care system more effective and efficient;and in the process, improve the quality of life for all.

Joseph D. BronzinoEditor-in-Chief


Editor-in-Chief

Joseph D. Bronzino received the B.S.E.E. degree from Worcester Polytechnic Institute, Worcester, MA,in 1959, the M.S.E.E. degree from the Naval Postgraduate School, Monterey, CA, in 1961, and the Ph.D.degree in electrical engineering from Worcester Polytechnic Institute in 1968. He is presently the VernonRoosa Professor of Applied Science, an endowed chair at Trinity College, Hartford, CT and Presidentof the Biomedical Engineering Alliance and Consortium (BEACON) which is a nonprofit organizationconsisting of academic and medical institutions as well as corporations dedicated to the development and

He is the author of over 200 articles and 11 books including the following: Technology for PatientCare (C.V. Mosby, 1977), Computer Applications for Patient Care (Addison-Wesley, 1982), BiomedicalEngineering: Basic Concepts and Instrumentation (PWS Publishing Co., 1986), Expert Systems: Basic Con-cepts (Research Foundation of State University of New York, 1989), Medical Technology and Society: AnInterdisciplinary Perspective (MIT Press and McGraw-Hill, 1990), Management of Medical Technology (But-terworth/Heinemann, 1992), The Biomedical Engineering Handbook (CRC Press, 1st ed., 1995; 2nd ed.,2000; Taylor & Francis, 3rd ed., 2005), Introduction to Biomedical Engineering (Academic Press, 1st ed.,1999; 2nd ed., 2005).

Dr. Bronzino is a fellow of IEEE and the American Institute of Medical and Biological Engineering(AIMBE), an honorary member of the Italian Society of Experimental Biology, past chairman of theBiomedical Engineering Division of the American Society for Engineering Education (ASEE), a chartermember and presently vice president of the Connecticut Academy of Science and Engineering (CASE),a charter member of the American College of Clinical Engineering (ACCE) and the Association for theAdvancement of Medical Instrumentation (AAMI), past president of the IEEE-Engineering in Medicineand Biology Society (EMBS), past chairman of the IEEE Health Care Engineering Policy Committee(HCEPC), past chairman of the IEEE Technical Policy Council in Washington, DC, and presently Editor-in-Chief of Elsevier’s BME Book Series and Taylor & Francis’ Biomedical Engineering Handbook.

Dr. Bronzino is also the recipient of the Millennium Award from IEEE/EMBS in 2000 and the GoddardAward from Worcester Polytechnic Institute for Professional Achievement in June 2004.


commercialization of new medical technologies (for details visit www.beaconalliance.org).

http://www.beaconalliance.org

Contributors

Joseph AdamPremise Development

CorporationHartford, Connecticut

P.D. AhlgrenVille Marie Multidisciplinary

Breast and Oncology CenterSt. Mary’s HospitalMcGill UniversityMontreal, Quebec, CanadaandLondon Cancer CentreLondon, OntarioCanada

William C. AmaluPacific Chiropractic and

Research CenterRedwood City, California

Kurt AmmerLudwig Boltzmann Research

Institute for PhysicalDiagnostics

Vienna, AustriaandMedical Imaging Research GroupSchool of ComputingUniversity of GlamorganPontypridd, WalesUnited Kingdom

Dennis D. AutioDybonics, Inc.Portland, Oregon

Raymond BalcerakDefense Advanced Research

Projects AgencyArlington, Virginia

D.C. BarberUniversity of SheffieldSheffield, United Kingdom

Khosrow BehbehaniThe University of Texas at

ArlingtonArlington, TexasandThe University of TexasSouthwestern Medical CenterDallas, Texas

N. BelliveauVille Marie Multidisciplinary

Breast and Oncology CenterSt. Mary’s HospitalMcGill UniversityMontreal, Quebec, CanadaandLondon Cancer CentreLondon, Ontario, Canada

Anna M. BianchiSt. Raffaele HospitalMilan, Italy

Carol J. BickfordAmerican Nurses AssociationWashington, D.C.

Jeffrey S. BlairIBM Health Care SolutionsAtlanta, Georgia

G. Faye Boudreaux-BartelsUniversity of Rhode Island

Kingston, Rhode Island

Bruce R. BowmanEdenTec Corporation

Eden Prairie, Minnesota

Joseph D. BronzinoTrinity CollegeBiomedical Engineering Alliance

and Consortium (BEACON)

Harford, Connecticut

Mark E. BruleyECRI

Plymouth Meeting, Pennsylvania

Richard P. BuckUniversity of North Carolina

Chapel Hill, North Carolina

P. BuddharajuDepartment of Computer Science

University of Houston

Houston, Texas

Thomas F. BudingerUniversity of California-Berkeley

Berkeley, California

Robert D. ButterfieldIVAC Corporation

San Diego, California

Joseph P. CammarotaNaval Air Warfare Center

Aircraft Division

Warminster, Pennsylvania


Paul CampbellInstitute of Medical Science

and TechnologyUniversities of St. Andrews

and DundeeandNinewells HospitalDundee, United Kingdom

Ewart R. CarsonCity UniversityLondon, United Kingdom

Sergio CeruttiPolytechnic UniversityMilan, Italy

A. Enis ÇetinBilkent UniversityAnkara, Turkey

Christopher S. ChenDepartment of BioengineeringDepartment of PhysiologyUniversity of PennsylvaniaPhiladelphia, Pennsylvania

Wei ChenCenter for Magnetic Resonance

ResearchandThe University of Minnesota

Medical SchoolMinneapolis, Minnesota

Victor ChernomordikLaboratory of Integrative and

Medical BiophysicsNational Institute of Child Health

and Human DevelopmentBethesda, Maryland

David A. CheslerMassachusetts General HospitalHarvard University Medical

SchoolBoston, Massachusetts

Vivian H. CoatesECRIPlymouth Meeting, Pennsylvania

Arnon CohenBen-Gurion UniversityBe’er Sheva, Israel

Steven ConollyStanford University

Stanford, California

Derek G. CrampCity University

London, United Kingdom

Barbara Y. CroftNational Institutes of Health

Kensington, Maryland

David D. CunninghamAbbott Diagnostics

Process Engineering

Abbott Park, Illinois

Ian A. CunninghamVictoria HospitalThe John P. Roberts Research

Institute

and

The University of Western Ontario

London, Ontario, Canada

Yadin DavidTexas Children’s Hospital

Houston, Texas

Connie White DelaneySchool of Nursing and Medical

School

The University of Minnesota

Minneapolis, Minnesota

Mary DiakidesAdvanced Concepts Analysis, Inc.

Falls Church, Virginia

Nicholas A. DiakidesAdvanced Concepts Analysis, Inc.Falls Church, Virginia

C. Drews-PeszynskiTechnical University of Lodz

Lodz, Poland

Ronald G. DriggersU.S. Army Communications and

Electronics Research,Development and EngineeringCenter (CERDEC)

Night Vision and ElectronicSensors Directorate

Fort Belvoir, Virginia

Gary DrzewieckiRutgers UniversityPiscataway, New Jersey

Edwin G. DuffinMedtronic, Inc.Minneapolis, Minnesota

Jeffrey L. EgglestonValleylab, Inc.Boulder, Colorado

Robert L. ElliottElliott-Elliott-Head Breast Cancer

Research and Treatment CenterBaton Rouge, Louisiana

K. Whittaker FerraraRiverside Research InstituteNew York, New York

J. Michael FitzmauriceAgency for Healthcare Research

and QualityRockville, Maryland

Ross FlewellingNellcor IncorporationPleasant, California

Michael FordeMedtronic, Inc.Minneapolis, Minnesota

Amir H. GandjbakhcheLaboratory of Integrative and



Israel GannotLaboratory of Integrative and



Leslie A. GeddesPurdue UniversityWest Lafayette, Indiana

Richard L. GoldbergUniversity of North CarolinaChapel Hill, North Carolina


Boris GramatikovJohns Hopkins School

of MedicineBaltimore, Maryland

Barton M. GrattSchool of DentistryUniversity of WashingtonSeattle, Washington

Walter GreenleafGreenleaf MedicalPalo Alto, California

Michael W. GrennU.S. Army Communications and




Eliot B. GriggDepartment of Plastic SurgeryDartmouth-Hitchcock Medical

CenterLebanon, New Hampshire

Warren S. GrundfestDepartment of Bioengineering

and Electrical EngineeringHenry Samueli School of

Engineering and AppliedScience

andDepartment of SurgeryDavid Geffen School

of MedicineUniversity of CaliforniaLos Angeles, California

Michael L. GulliksonTexas Children’s HospitalHouston, Texas

Moinuddin HassanLaboratory of Integrative and



David HatteryLaboratory of Integrative and

Medical Biophysics

National Institute of Child Healthand Human Development

Bethesda, Maryland

Jonathan F. HeadElliott-Elliott-Head Breast Cancer

Research and Treatment Center

Baton Rouge, Louisiana

William B. HobbinsWomen’s Breast Health Center

Madison, Wisconsin

Stuart HornU.S. Army Communications and




Xiaoping HuCenter for Magnetic Resonance

Research

and

The University of MinnesotaMedical School


T. JakubowskaTechnical University of Lodz

Lodz, Poland

G. Allan JohnsonDuke University Medical Center

Durham, North Carolina

Bryan F. JonesMedical Imaging Research Group

School of Computing

University of Glamorgan

Pontypridd, Wales

United Kingdom

Thomas M. JuddKaiser Permanente

Atlanta, Georgia

Millard M. JudyBaylor Research Institute and

MicroBioMed Corp.Dallas, Texas

Philip F. JudyBrigham and Women’s HospitalHarvard University Medical


G.J.L. KawDepartment of Diagnostic

RadiologyTan Tock Seng HospitalSingapore

J.R. KeyserlingkVille Marie Multidisciplinary

Breast and Oncology CenterSt. Mary’s HospitalMcGill UniversityMontreal, Quebec, CanadaandLondon Cancer CentreLondon, OntarioCanada

C. Everett KoopDepartment of Plastic SurgeryDartmouth-Hitchcock Medical


Hayrettin KöymenBilkent UniversityAnkara, Turkey

Luis G. KunIRMC/National Defense

UniversityWashington, D.C.

Phani Teja KurugantiRF and Microwave Systems GroupOak Ridge National LaboratoryOak Ridge, Tennessee

Kenneth K. KwongMassachusetts General HospitalHarvard University Medical



Z.R. LiSouth China Normal University

Guangzhou, China

Richard F. LittleNational Institutes of Health

Bethesda, Maryland

Chung-Chiun LiuElectronics Design Center and

Edison Sensor TechnologyCenter

Case Western Reserve University

Cleveland, Ohio

Zhongqi LiuTTM Management Group

Beijing, China

Jasper LupoApplied Research Associates, Inc.


Albert MacovskiStanford University


Luca T. MainardiPolytechnic University

Milan, Italy

C. ManoharDepartment of Electrical &

Computer Engineering


Houston, Texas

Joseph P. McClainWalter Reed Army Medical Center

Washington, D.C.

Kathleen A. McCormickSAIC


Dennis McGrathDepartment of Plastic Surgery

Dartmouth-Hitchcock MedicalCenter

Lebanon, New Hampshire

Susan McGrathDepartment of Plastic Surgery



Matthew F. McKnightDepartment of Plastic Surgery



Yitzhak MendelsonWorcester Polytechnic Institute

Worcester, Massachusetts

James B. MercerUniversity of Tromsø

Tromsø, Norway

Arcangelo MerlaDepartment of Clinical Sciences

and Bioimaging

University “G.d’Annunzio”

and

Institute for Advanced BiomedicalTechnology

Foundation “G.d’Annunzio”

and

Istituto Nazionale Fisica dellaMateria

Coordinated Group of Chieti

Chieti-Pescara, Italy

Evangelia Micheli-TzanakouRutgers Unversity

Piscataway, New Jersey

Robert L. MorrisDybonics, Inc.

Portland, Oregon

Jack G. MottleyUniversity of Rochester

Rochester, New York

Robin MurrayUniversity of Rhode Island

Kingston, Rhode Island

Joachim H. NagelUniversity of Stuttgart

Stuttgart, Germany

Michael R. NeumanMichigan Technological

University

Houghton, Michigan

E.Y.K. NgCollege of Engineering

School of Mechanical andProduction Engineering

Nanyang Technological University

Singapore

Paul NortonU.S. Army Communications and




Antoni NowakowskiDepartment of Biomedical

Engineering,

Gdansk University of Technology

Narutowicza

Gdansk, Poland

Banu OnaralDrexel University

Philadelphia, Pennsylvania

David D. PascoeAuburn University

Auburn, Alabama

Maqbool PatelCenter for Magnetic Resonance

Research

and

The University of MinnesotaMedical School


Robert PattersonThe University of Minnesota


Jeffrey L. PaulDefense Advanced Research

Projects Agency

Arlington, Virginia

A. William PaulsenEmory University

Atlanta, Georgia


John PaulyStanford University


I. PavlidisDepartment of Computer Science


Houston, Texas

P. Hunter PeckhamCase Western Reserve University

Cleveland, Ohio

Joseph G. PellegrinoU.S. Army Communications and




Philip PercontiU.S. Army Communications and




Athina P. PetropuluDrexel University


Tom PiantanidaGreenleaf Medical

Palo Alto, California

T. Allan PryorUniversity of Utah

Salt Lake City, Utah

Ram C. PurohitAuburn University

Auburn, Alabama

Hairong QiECE Department

The University of Tennessee

Knoxville, Tennessee

Pat RidgelyMedtronic, Inc.


E. Francis RingMedical Imaging Research GroupSchool of ComputingUniversity of GlamorganPontypridd, WalesUnited Kingdom

Richard L. RoaBaylor University Medical CenterDallas, Texas

Peter RobbieDepartment of Plastic SurgeryDartmouth-Hitchcock Medical


Gian Luca RomaniDepartment of Clinical Sciences

and BioimagingUniversity “G. d’Annunzio”andInstitute for Advanced

Biomedical TechnologyFoundation “G.d’Annunzio”andIstituto Nazionale Fisica della

MateriaCoordinated Group of ChietiChieti-Pescara, Italy

Joseph M. RosenDepartment of Plastic SurgeryDartmouth-Hitchcock Medical


Eric RosowHartford HospitalandPremise Development

CorporationHartford, Connecticut

Subrata SahaClemson UniversityClemson, South Carolina

John SchenckGeneral Electric Corporate

Research and DevelopmentCenter

Schenectady, New York

Edward SchuckEdenTec CorporationEden Prairie, Minnesota

Joyce SensmeierHIMSS

Chicago, Illinois

David ShermanJohns Hopkins School of Medicine

Baltimore, Maryland

Robert E. Shroy, Jr.Picker International

Highland Heights, Ohio

Stephen W. SmithDuke University


Nathan J. SniadeckiDepartment of Bioengineering

University of Pennsylvania


Wesley E. SnyderECE Department

North Carolina State University

Raleigh, North Carolina

Orhan SoykanCorporate Science and

Technology

Medtronic, Inc.

andDepartment of Biomedical

Engineering

Michigan TechnologicalUniversity

Houghton, Michigan

Primoz StrojnikCase Western Reserve University

Cleveland, Ohio

M. StrzeleckiTechnical University of Lodz

Lodz, Poland

Ron SummersLoughborough University

Leicestershire, United Kingdom

Christopher SwiftDepartment of Plastic Surgery



Willis A. TackerPurdue University

West Lafayette, Indiana


Nitish V. ThakorJohns Hopkins School of MedicineBaltimore, Maryland

Roderick ThomasFaculty of Applied Design and

EngineeringSwansea Institute of TechnologySwansea, United Kingdom

P. TsiamyrtzisDepartment of StatisticsUniversity of Economics and

Business AthensAthens, Greece

Benjamin M.W. TsuiUniversity of North CarolinaChapel Hill, North Carolina

Tracy A. TurnerPrivate PracticeMinneapolis, Minnesota

Kamil UgurbilCenter for Magnetic Resonance

ResearchandThe University of Minnesota

Medical SchoolMinneapolis, Minnesota

Michael S. Van LyselUniversity of WisconsinMadison, Wisconsin

Henry F. VanBrocklinUniversity of California-BerkeleyBerkeley, California

Jay VizgaitisU.S. Army Communications and




Abby VogelLaboratory of Integrative and



Wolf W. von MaltzahnRensselaer Polytechnic InstituteTroy, New York

Gregory I. VossIVAC CorporationSan Diego, California

Alvin WaldColumbia UniversityNew York, New York

Chen WangTTM InternationalHouston, Texas

Lois de WeerdUniversity Hospital of

North NorwayTromsø, Norway

Wang WeiRadiology DepartmentBeijing You An HospitalBeijing, China

B. WiecekTechnical University of LodzLodz, Poland

M. WysockiTechnical University of LodzLodz, Poland

Martin J. YaffeUniversity of TorontoToronto, Ontario, Canada

Robert YarchoanHIV and AIDS Malignancy

BranchCenter for Cancer ResearchNational Cancer Institute (NCI)Bethesda, Maryland

M. YassaVille Marie Multidisciplinary

Breast and Oncology CenterSt. Mary’s HospitalMcGill UniversityMontreal, Quebec, CanadaandLondon Cancer CentreLondon, Ontario, Canada

Christopher M. YipDepartments of Chemical

Engineering and AppliedChemistry

Department of Biochemistry

Institute of Biomaterials andBiomedical Engineering

University of Toronto

Toronto, Ontario, Canada

E. YuVille Marie Multidisciplinary

Breast and Oncology Center

St. Mary’s Hospital

McGill University

Montreal, Quebec, Canada

and

London Cancer Centre

London, Ontario, Canada

Wen YuShanghai RuiJin Hospital

Shanghai, China

Yune YuanInstitute of Basic Medical Science

China Army General Hospital

Beijing, China

Jason ZeibelU.S. Army Communications and




Yi ZengCentral Disease Control of China

Beijing, China

Xiaohong ZhouDuke University Medical Center


Yulin ZhouShanghai RuiJin Hospital

Shanghai, China


Contents

SECTION I Biomedical Signal Analysis

Banu Onaral

1 Biomedical Signals: Origin and Dynamic Characteristics;Frequency-Domain AnalysisArnon Cohen . . . . . . . . . . . . . . . . . . . . . 1-1

2 Digital Biomedical Signal Acquisition and ProcessingLuca T. Mainardi, Anna M. Bianchi, Sergio Cerutti . . . . 2-1

3 Compression of Digital Biomedical SignalsA. Enis Çetin, Hayrettin Köymen . . . . . . . . . . . . 3-1

4 Time-Frequency Signal Representations forBiomedical SignalsG. Faye Boudreaux-Bartels, Robin Murray . . . . . . . . 4-1

5 Wavelet (Time-Scale) Analysis in BiomedicalSignal ProcessingNitish V. Thakor, Boris Gramatikov, David Sherman . . . 5-1

6 Higher-Order Spectral AnalysisAthina P. Petropulu . . . . . . . . . . . . . . . . . . 6-1

7 Neural Networks in Biomedical Signal ProcessingEvangelia Micheli-Tzanakou . . . . . . . . . . . . . . 7-1

8 Complexity, Scaling, and Fractals in Biomedical SignalsBanu Onaral, Joseph P. Cammarota . . . . . . . . . . . 8-1

9 Future Directions: Biomedical Signal Processing andNetworked Multimedia CommunicationsBanu Onaral . . . . . . . . . . . . . . . . . . . . . 9-1


SECTION II Imaging

Warren S. Grundfest

10 X-RayRobert E. Shroy, Jr., Michael S. Van Lysel,Martin J. Yaffe . . . . . . . . . . . . . . . . . . . . 10-1

11 Computed TomographyIan A. Cunningham, Philip F. Judy . . . . . . . . . . . 11-1

12 Magnetic Resonance ImagingSteven Conolly, Albert Macovski, John Pauly, John Schenck,Kenneth K. Kwong, David A. Chesler, Xiaoping Hu,Wei Chen, Maqbool Patel, Kamil Ugurbil . . . . . . . . 12-1

13 Nuclear MedicineBarbara Y. Croft, Benjamin M.W. Tsui . . . . . . . . . . 13-1

14 UltrasoundRichard L. Goldberg, Stephen W. Smith, Jack G. Mottley,K. Whittaker Ferrara . . . . . . . . . . . . . . . . . 14-1

15 Magnetic Resonance MicroscopyXiaohong Zhou, G. Allan Johnson . . . . . . . . . . . . 15-1

16 Positron-Emission Tomography (PET)Thomas F. Budinger, Henry F. VanBrocklin . . . . . . . . 16-1

17 Electrical Impedance TomographyD.C. Barber . . . . . . . . . . . . . . . . . . . . . 17-1

18 Medical Applications of Virtual Reality TechnologyWalter Greenleaf, Tom Piantanida . . . . . . . . . . . 18-1

SECTION III Infrared Imaging

Nicholas A. Diakides

19 Advances in Medical Infrared ImagingNicholas Diakides, Mary Diakides, Jasper Lupo,Jeffrey L. Paul, Raymond Balcerak . . . . . . . . . . . 19-1

20 The Historical Development of Thermometryand Thermal Imaging in MedicineE. Francis Ring, Bryan F. Jones . . . . . . . . . . . . . 20-1


21 Physiology of Thermal SignalsDavid D. Pascoe, James B. Mercer, Lois de Weerd . . . . . 21-1

22 Quantitative Active Dynamic Thermal IR-Imaging andThermal Tomography in Medical DiagnosticsAntoni Nowakowski . . . . . . . . . . . . . . . . . 22-1

23 Thermal Texture Maps (TTM): Concept, Theory, andApplicationsZhongqi Liu, Chen Wang, Hairong Qi, Yune Yuan, Yi Zeng,Z.R. Li, Yulin Zhou, Wen Yu, Wang Wei . . . . . . . . . 23-1

24 IR Imagers as Fever Monitoring Devices: Physics,Physiology, and Clinical AccuracyE.Y.K. Ng, G.J.L. Kaw . . . . . . . . . . . . . . . . . 24-1

25 Infrared Imaging of the Breast — An OverviewWilliam C. Amalu, William B. Hobbins, Jonathan F. Head,Robert L. Elliott . . . . . . . . . . . . . . . . . . . 25-1

26 Functional Infrared Imaging of the Breast:Historical Perspectives, Current Application, andFuture ConsiderationsJ.R. Keyserlingk, P.D. Ahlgren, E. Yu, N. Belliveau,M. Yassa . . . . . . . . . . . . . . . . . . . . . . . 26-1

27 Detecting Breast Cancer from Thermal Infrared Images byAsymmetry AnalysisHairong Qi, Phani Teja Kuruganti, Wesley E. Snyder . . . 27-1

28 Advanced Thermal Image ProcessingB. Wiecek, M. Strzelecki, T. Jakubowska, M. Wysocki,C. Drews-Peszynski . . . . . . . . . . . . . . . . . . 28-1

29 Biometrics: Face Recognition in Thermal InfraredI. Pavlidis, P. Tsiamyrtzis, P. Buddharaju, C. Manohar . . . 29-1

30 Infrared Imaging for Tissue Characterization and FunctionMoinuddin Hassan, Victor Chernomordik, Abby Vogel,David Hattery, Israel Gannot, Richard F. Little,Robert Yarchoan, Amir H. Gandjbakhche . . . . . . . . 30-1

31 Thermal Imaging in Diseases of the Skeletal andNeuromuscular SystemsE. Francis Ring, Kurt Ammer . . . . . . . . . . . . . . 31-1

32 Functional Infrared Imaging in Clinical ApplicationsArcangelo Merla, Gian Luca Romani . . . . . . . . . . 32-1


33 Thermal Imaging in SurgeryPaul Campbell, Roderick Thomas . . . . . . . . . . . . 33-1

34 Infrared Imaging Applied to DentistryBarton M. Gratt . . . . . . . . . . . . . . . . . . . 34-1

35 Use of Infrared Imaging in Veterinary MedicineRam C. Purohit, Tracy A. Turner, David D. Pascoe . . . . 35-1

36 Standard Procedures for Infrared Imaging in MedicineKurt Ammer, E. Francis Ring . . . . . . . . . . . . . . 36-1

37 Infrared Detectors and Detector ArraysPaul Norton, Stuart Horn, Joseph G. Pellegrino,Philip Perconti . . . . . . . . . . . . . . . . . . . . 37-1

38 Infrared Camera CharacterizationJoseph G. Pellegrino, Jason Zeibel, Ronald G. Driggers,Philip Perconti . . . . . . . . . . . . . . . . . . . . 38-1

39 Infrared Camera and Optics for Medical ApplicationsMichael W. Grenn, Jay Vizgaitis, Joseph G. Pellegrino,Philip Perconti . . . . . . . . . . . . . . . . . . . . 39-1

SECTION IV Medical Informatics

Luis G. Kun

40 Hospital Information Systems: Their Function and StateT. Allan Pryor . . . . . . . . . . . . . . . . . . . . 40-1

41 Computer-Based Patient RecordsJ. Michael Fitzmaurice . . . . . . . . . . . . . . . . . 41-1

42 Overview of Standards Related to the Emerging Health CareInformation InfrastructureJeffrey S. Blair . . . . . . . . . . . . . . . . . . . . 42-1

43 Introduction to Informatics and NursingKathleen A. McCormick, Joyce Sensmeier,Connie White Delaney, Carol J. Bickford . . . . . . . . . 43-1

44 Non-AI Decision MakingRon Summers, Derek G. Cramp, Ewart R. Carson . . . . . 44-1


45 Medical Informatics and Biomedical Emergencies: NewTraining and Simulation Technologies for First RespondersJoseph M. Rosen, Christopher Swift, Eliot B. Grigg,Matthew F. McKnight, Susan McGrath, Dennis McGrath,Peter Robbie, C. Everett Koop . . . . . . . . . . . . . 45-1

SECTION V Biomedical Sensors

Michael R. Neuman

46 Physical MeasurementsMichael R. Neuman . . . . . . . . . . . . . . . . . . 46-1

47 Biopotential ElectrodesMichael R. Neuman . . . . . . . . . . . . . . . . . . 47-1

48 Electrochemical SensorsChung-Chiun Liu . . . . . . . . . . . . . . . . . . . 48-1

49 Optical SensorsYitzhak Mendelson . . . . . . . . . . . . . . . . . . 49-1

50 Bioanalytic SensorsRichard P. Buck . . . . . . . . . . . . . . . . . . . 50-1

51 Biological Sensors for DiagnosticsOrhan Soykan . . . . . . . . . . . . . . . . . . . . 51-1

SECTION VI Medical Instruments and Devices

Wolf W. von Maltzahn

52 Biopotential AmplifiersJoachim H. Nagel . . . . . . . . . . . . . . . . . . . 52-1

53 Bioelectric Impedance MeasurementsRobert Patterson . . . . . . . . . . . . . . . . . . . 53-1

54 Implantable Cardiac PacemakersMichael Forde, Pat Ridgely . . . . . . . . . . . . . . . 54-1

55 Noninvasive Arterial Blood Pressure and MechanicsGary Drzewiecki . . . . . . . . . . . . . . . . . . . 55-1


56 Cardiac Output MeasurementLeslie A. Geddes . . . . . . . . . . . . . . . . . . . 56-1

57 External DefibrillatorsWillis A. Tacker . . . . . . . . . . . . . . . . . . . 57-1

58 Implantable DefibrillatorsEdwin G. Duffin . . . . . . . . . . . . . . . . . . . 58-1

59 Implantable Stimulators for Neuromuscular ControlPrimoz Strojnik, P. Hunter Peckham . . . . . . . . . . 59-1

60 RespirationLeslie A. Geddes . . . . . . . . . . . . . . . . . . . 60-1

61 Mechanical VentilationKhosrow Behbehani . . . . . . . . . . . . . . . . . . 61-1

62 Essentials of Anesthesia DeliveryA. William Paulsen . . . . . . . . . . . . . . . . . . 62-1

63 Electrosurgical DevicesJeffrey L. Eggleston, Wolf W. von Maltzahn . . . . . . . . 63-1

64 Biomedical LasersMillard M. Judy . . . . . . . . . . . . . . . . . . . . 64-1

65 Instrumentation for Cell MechanicsNathan J. Sniadecki, Christopher S. Chen . . . . . . . . 65-1

66 Blood Glucose MonitoringDavid D. Cunningham . . . . . . . . . . . . . . . . 66-1

67 Atomic Force Microscopy: Probing BiomolecularInteractionsChristopher M. Yip . . . . . . . . . . . . . . . . . . 67-1

68 Parenteral Infusion DevicesGregory I. Voss, Robert D. Butterfield . . . . . . . . . . 68-1

69 Clinical Laboratory: Separation and Spectral MethodsRichard L. Roa . . . . . . . . . . . . . . . . . . . . 69-1

70 Clinical Laboratory: Nonspectral Methods and AutomationRichard L. Roa . . . . . . . . . . . . . . . . . . . . 70-1

71 Noninvasive Optical MonitoringRoss Flewelling . . . . . . . . . . . . . . . . . . . . 71-1


72 Medical Instruments and Devices Used in the HomeBruce R. Bowman, Edward Schuck . . . . . . . . . . . 72-1

73 Virtual Instrumentation: Applications in BiomedicalEngineeringEric Rosow, Joseph Adam . . . . . . . . . . . . . . . 73-1

SECTION VII Clinical Engineering

Yadin David

74 Clinical Engineering: Evolution of a DisciplineJoseph D. Bronzino . . . . . . . . . . . . . . . . . . 74-1

75 Management and Assessment of Medical TechnologyYadin David, Thomas M. Judd . . . . . . . . . . . . . 75-1

76 Risk Factors, Safety, and Management of Medical EquipmentMichael L. Gullikson . . . . . . . . . . . . . . . . . 76-1

77 Clinical Engineering Program IndicatorsDennis D. Autio, Robert L. Morris . . . . . . . . . . . . 77-1

78 Quality of Improvement and Team BuildingJoseph P. McClain . . . . . . . . . . . . . . . . . . . 78-1

79 A Standards Primer for Clinical EngineersAlvin Wald . . . . . . . . . . . . . . . . . . . . . 79-1

80 Regulatory and Assessment AgenciesMark E. Bruley, Vivian H. Coates . . . . . . . . . . . . 80-1

81 Applications of Virtual Instruments in Health CareEric Rosow, Joseph Adam . . . . . . . . . . . . . . . 81-1

SECTION VIII Ethical Issues Associated withthe Use of Medical Technology

Subrata Saha and Joseph D. Bronzino

82 Beneficence, Nonmaleficence, and Medical TechnologyJoseph D. Bronzino . . . . . . . . . . . . . . . . . . 82-1

83 Ethical Issues Related to Clinical ResearchJoseph D. Bronzino . . . . . . . . . . . . . . . . . . 83-1


medical devices and sistems

Documents