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عدد المساهمات : 18984 التقييم : 35458 تاريخ التسجيل : 01/07/2009 الدولة : مصر العمل : مدير منتدى هندسة الإنتاج والتصميم الميكانيكى
| موضوع: كتاب Biomaterials Science - An Introduction to Materials in Medicine الثلاثاء 22 أكتوبر 2013, 7:03 am | |
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أخوانى فى الله أحضرت لكم كتاب Biomaterials Science - An Introduction to Materials in Medicine 2nd Edition Edited by Buddy D. Ratner, Ph.D. Professor, Bioengineering and Chemical Engineering Director of University of Washington Engineered Biomaterials (UWEB), an NSF Engineering Research Center University of Washington, Seattle, WA USA Allan S. Hoffman, ScD. Professor of Bioengineering and Chemical Engineering UWEB Investigator University of Washington, Seattle, WA USA Frederick J. Schoen, M.D., Ph.D. Professor of Pathology and Health Sciences and Technology (HST) Harvard Medical School Executive Vice Chairman, Department of Pathology Brigham and Women’s Hospital Boston, MA USA Jack E. Lemons, Ph.D. Professor and Director of Biomaterials Laboratory Surgical Research Departments of Prosthodontics and Biomaterials, Orthopaedic Surgery/Surgery and Biomedical Engineering, Schools of Dentistry, Medicine and Engineering University of Alabama at Birmingham, AL USA
و المحتوى كما يلي :
CONTENTS Editors and Lead Contributors ix Preface xi Biomaterials Science: A Multidisciplinary Endeavor 1 BUDDY D. RATNER, ALLAN S. HOFFMAN, FREDERICK J. SCHOEN, AND JACK E. LEMONS A History of Biomaterials 10 BUDDY D. RATNER PART I MATERIALS SCIENCE AND ENGINEERING CHAPTER 1 Properties of Materials 1.1 Introduction 23 JACK E. LEMONS 1.2 Bulk Properties of Materials 23 FRANCIS W. COOKE 1.3 Finite Element Analysis 32 IVAN VESELY AND EVELYN OWEN CAREW 1.4 Surface Properties and Surface Characterization of Materials 40 BUDDY D. RATNER 1.5 Role of Water in Biomaterials 59 ERWIN A. VOGLER CHAPTER 2 Classes of Materials Used in Medicine 2.1 Introduction 67 ALLAN S. HOFFMAN 2.2 Polymers 67 STUART L. COOPER, SUSAN A. VISSER, ROBERT W. HERGENROTHER, AND NINA M. K. LAMBA 2.3 Silicone Biomaterials: History and Chemistry 80 ANDRÉ COLAS AND JIM CURTIS 2.4 Medical Fibers and Biotextiles 86 STEVEN WEINBERG AND MARTIN W. KING 2.5 Hydrogels 100 NICHOLAS A. PEPPAS 2.6 Applications of “Smart Polymers” as Biomaterials 107 ALLAN S. HOFFMAN 2.7 Bioresorbable and Bioerodible Materials 115 JOACHIM KOHN, SASCHA ABRAMSON, AND ROBERT LANGER 2.8 Natural Materials 127 IOANNIS V. YANNAS 2.9 Metals 137 JOHN B. BRUNSKI 2.10 Ceramics, Glasses, and Glass-Ceramics 153 LARRY L. HENCH AND SERENA BEST 2.11 Pyrolytic Carbon for Long-Term Medical Implants 170 ROBERT B. MORE, AXEL D. HAUBOLD, AND JACK C. BOKROS 2.12 Composites 181 CLAUDIO MIGLIARESI AND HAROLD ALEXANDER 2.13 Nonfouling Surfaces 197 BUDDY D. RATNER AND ALLAN S. HOFFMAN vvi CONTENTS 2.14 Physicochemical Surface Modification of Materials Used in Medicine 201 BUDDY D. RATNER AND ALLAN S. HOFFMAN 2.15 Textured and Porous Materials 218 JOHN A. JANSEN AND ANDREAS F. VON RECUM 2.16 Surface-Immobilized Biomolecules 225 ALLAN S. HOFFMAN AND JEFFREY A. HUBBELL PART II BIOLOGY, BIOCHEMISTRY, AND MEDICINE CHAPTER 3 Some Background Concepts 3.1 Background Concepts 237 BUDDY D. RATNER 3.2 The Role of Adsorbed Proteins in Tissue Response to Biomaterials 237 THOMAS A. HORBETT 3.3 Cells and Cell Injury 246 RICHARD N. MITCHELL AND FREDERICK J. SCHOEN 3.4 Tissues, the Extracellular Matrix, and Cell–Biomaterial Interactions 260 FREDERICK J. SCHOEN AND RICHARD N. MITCHELL 3.5 Mechanical Forces on Cells 282 LARRY V. MCINTIRE, SUZANNE G. ESKIN, AND ANDREW YEE CHAPTER 4 Host Reactions to Biomaterials and Their Evaluation 4.1 Introduction 293 FREDERICK J. SCHOEN 4.2 Inflammation, Wound Healing, and the Foreign-Body Response 296 JAMES M. ANDERSON 4.3 Innate and Adaptive Immunity: The Immune Response to Foreign Materials 304 RICHARD N. MITCHELL 4.4 The Complement System 318 RICHARD J. JOHNSON 4.5 Systemic Toxicity and Hypersensitivity 328 ARNE HENSTEN-PETTERSEN AND NILS JACOBSEN 4.6 Blood Coagulation and Blood–Materials Interactions 332 STEPHEN R. HANSON 4.7 Tumorigenesis and Biomaterials 338 FREDERICK J. SCHOEN 4.8 Biofilms, Biomaterials, and Device-Related Infections 345 BILL COSTERTON, GUY COOK, MARK SHIRTLIFF, PAUL STOODLEY, AND MARK PASMORE CHAPTER 5 Biological Testing of Biomaterials 5.1 Introduction to Testing Biomaterials 355 BUDDY D. RATNER 5.2 In Vitro Assessment of Tissue Compatibility 356 SHARON J. NORTHUP 5.3 In Vivo Assessment of Tissue Compatibility 360 JAMES M. ANDERSON AND FREDERICK J. SCHOEN 5.4 Evaluation of Blood-Materials Interactions 367 STEPHEN R. HANSON AND BUDDY D. RATNER 5.5 Large Animal Models in Cardiac and Vascular Biomaterials Research and Testing 379 RICHARD W. BIANCO, JOHN F. GREHAN, BRIAN C. GRUBBS, JOHN P. MRACHEK, ERIK L. SCHROEDER, CLARK W. SCHUMACHER, CHARLES A. SVENDSEN, AND MATT LAHTI 5.6 Microscopy for Biomaterials Science 396 KIP D. HAUCH CHAPTER 6 Degradation of Materials in the Biological Environment 6.1 Introduction: Degradation of Materials in the Biological Environment 411 BUDDY D. RATNER 6.2 Chemical and Biochemical Degradation of Polymers 411 ARTHUR J. COURY 6.3 Degradative Effects of the Biological Environment on Metals and Ceramics 430 DAVID F. WILLIAMS AND RACHEL L. WILLIAMS 6.4 Pathological Calcification of Biomaterials 439 FREDERICK J. SCHOEN AND ROBERT J. LEVYCONTENTS vii CHAPTER 7 Application of Materials in Medicine, Biology, and Artificial Organs 7.1 Introduction 455 JACK E. LEMONS AND FREDERICK J. SCHOEN 7.2 Nonthrombogenic Treatments and Strategies 456 MICHAEL V. SEFTON AND CYNTHIA H. GEMMELL 7.3 Cardiovascular Medical Devices 470 ROBERT F. PADERA, JR., AND FREDERICK J. SCHOEN 7.4 Implantable Cardiac Assist Devices 494 WILLIAM R. WAGNER, HARVEY S. BOROVETZ, AND BARTLEY P. GRIFFITH 7.5 Artificial Red Blood Cell Substitutes 507 THOMAS MING SWI CHANG 7.6 Extracorporeal Artificial Organs 514 PAUL S. MALCHESKY 7.7 Orthopedic Applications 527 NADIM JAMES HALLAB, JOSHUA J. JACOBS, AND J. LAWRENCE KATZ 7.8 Dental Implantation 556 A. NORMAN CRANIN AND JACK E. LEMONS 7.9 Adhesives and Sealants 573 DENNIS C. SMITH 7.10 Ophthalmological Applications 584 MIGUEL F. REFOJO 7.11 Intraocular Lens Implants: A Scientific Perspective 592 ANIL S. PATEL 7.12 Burn Dressings and Skin Substitutes 603 JEFFREY R. MORGAN, ROBERT L. SHERIDAN, RONALD G. TOMPKINS, MARTIN L. YARMUSH, AND JOHN F. BURKE 7.13 Sutures 615 MARK S. ROBY AND JACK KENNEDY 7.14 Drug Delivery Systems 629 JORGE HELLER AND ALLAN S. HOFFMAN 7.15 Bioelectrodes 649 RAMAKRISHNA VENUGOPALAN AND RAY IDEKER 7.16 Cochlear Prostheses 658 FRANCIS A. SPELMAN 7.17 Biomedical Sensors and Biosensors 670 PAUL YAGER 7.18 Diagnostics and Biomaterials 685 PETER J. TARCHA AND THOMAS E. ROHR 7.19 Medical Applications of Silicones 698 JIM CURTIS AND ANDRÉ COLAS CHAPTER 8 Tissue Engineering 8.1 Introduction 709 FREDERICK J. SCHOEN 8.2 Overview of Tissue Engineering 712 SIMON P. HOERSTRUP AND JOSEPH P. VACANTI 8.3 Immunoisolation 728 MICHAEL J. LYSAGHT AND DAVID REIN 8.4 Synthetic Bioresorbable Polymer Scaffolds 735 ANTONIOS G. MIKOS, LICHUN LU, JOHNNA S. TEMENOFF, AND JOERG K. TESSMAR PART III PRACTICAL ASPECTS OF BIOMATERIALS CHAPTER 9 Implants, Devices, and Biomaterials: Issues Unique to this Field 9.1 Introduction 753 FREDERICK J. SCHOEN 9.2 Sterilization of Implants and Devices 754 JOHN B. KOWALSKI AND ROBERT F. MORRISSEY 9.3 Implant and Device Failure 760 FREDERICK J. SCHOEN AND ALLAN S. HOFFMAN 9.4 Correlation, Surfaces and Biomaterials Science 765 BUDDY D. RATNER 9.5 Implant Retrieval and Evaluation 771 JAMES M. ANDERSON, FREDERICK J. SCHOEN, STANLEY A. BROWN, AND KATHARINE MERRITT CHAPTER 10 New Products and Standards 10.1 Introduction 783 JACK E. LEMONS 10.2 Voluntary Consensus Standards 783 JACK E. LEMONS 10.3 Development and Regulation of Medical Products Using Biomaterials 788 ELAINE DUNCANviii CONTENTS 10.4 Ethical Issues in the Development of New Biomaterials 793 SUBRATA SAHA AND PAMELA SAHA 10.5 Legal Aspects of Biomaterials 797 JAY P. MAYESH AND MARY F. SCRANTON CHAPTER 11 Perspectives and Possibilities in Biomaterials Science 805 BUDDY D. RATNER, FREDERICK J. SCHOEN, JACK E. LEMONS, AND ALLAN S. HOFFMAN APPENDIX A Properties of Biological Fluids 813 STEVEN M. SLACK APPENDIX B Properties of Soft Materials 819 CRISTINA L. MARTINS APPENDIX C Chemical Compositions of Metals Used for Implants 823 JOHN B. BRUNSKI APPENDIX D The Biomaterials Literature 825 Index INDEX A Absorbable matrix composites, 191 Absorbable synthetic fibers, 90 Absorbable synthetic sutures, 618–621 Absorption, multilayer polyelectrolyte, 211–212 Accommodative IOLs, 598–599 Acids; See Poly(amino acids); pseudo-poly(amino acids), 119 Act, Biomaterials Access Assurance, 803 Activity, platelet coagulant, 334 Acute inflammation, 298–299 Adaptive immunity innate and, 304–318 recognition and effector pathways in, 309–311 types of, 309 Adaptor/adhesive molecules, 263 Adhesion bacterial, 347 platelet, 333 Adhesion proteins, effects of, 238–240 Adhesive biomaterials, composition and characteristics of, 576–581 Adhesive molecules; See Adaptor/adhesive molecules Adhesives hard-tissue, 579–580 soft-tissue, 576–579 surgical, 590 Adhesives and sealants, 572–583 background concepts, 573–576 characteristics of adhesive biomaterials, 576–581 composition of adhesive biomaterials, 576–581 historical overview, 572–573 new research directions, 581–582 Adjustable power IOLs, 599 Adsorbed proteins in biomaterials, importance of, 245 Adsorbed proteins in tissue response to biomaterials, 237–246 adsorption behavior of proteins at solid/liquid interfaces, 240–242 conformational and biological changes, 242–245 effects of adhesion proteins on cellular interactions, 238–240 importance of adsorbed proteins in biomaterials, 245 molecular spreading events, 242–245 Adsorption behavior of proteins at solid/liquid interfaces, 240–242 Adsorption; See also Preadsorption; sorption AFM (atomic force microscopy), 51–54, 221 Agar diffusion test, 358 Agents immobilization of anti-platelet, 465–466 immobilization of fibrinolytic, 466 Aggregation, platelet, 333–334 Allergies, types of, 330–331 Allergy and biomaterials, 330 Allografts from cadavers, 605–606 of cultured cells and collagen, 606 Alloys cobalt-based, 144–148 cobalt-chromium, 536–537 new cobalt, 538–539 new tantalum, 537–538 new titanium, 538 new zirconium, 537–538 stainless steel, 536 titanium, 537 titanium-based, 148–151 Alloys, new, 537–539 new cobalt alloys, 538–539 new stainless steels, 539 new titanium alloys, 538 new zirconium and tantalum alloys, 537–538 surfaces and coatings, 539 Amino acids; See Poly(amino acids); pseudo-poly(amino acids) Amorphous matrix, 265 Analyses, finite element, 32–40 continuum equations, 35–36 examples from biomechanics, 37–40 finite element equations, 36–37 overview of finite element method, 33–35 surface analysis techniques, 42–56 Analyses, gene expression, 808 Animal experimentation, 794 Animal models and species consideration, 381–390 canine, 381–386 sheep, 388–390 swine, 386–388 Animal models in cardiac research testing, large, 379–396 Animal models in research testing, large animal models and species consideration, 381–390 responsible use of animals, 380–381 testing hierarchies, 390–392 Animal models in vascular research testing, large, 379–396 Animal models, selection of for in vivo tests, 364–365 Animal tumors, implants with human and, 339–341 Animals, responsible use of, 380–381 Anti-platelet agents, immobilization of, 465–466 Antibody-mediated disease, pathogenesis of, 313–314 antibody bound to cell surfaces or fixed tissue antigens, 313–314 831832 INDEX Antibody-mediated disease, pathogenesis of (Continued) IC (immune complex)-mediated injury, 314 IgE-mediated (immediate hypersensitivity), 313 Apheresis, 516–524 centrifugal plasma separation, 519–520 cytapheresis, 523–524 defined, 518 membrane plasma filtration, 522–523 membrane plasma separation, 520–522 miscellaneous physicochemical methods, 523 plasma exchange, 518–519 plasma treatment, 522 sorption plasma fractionation, 523 Apoptosis, 258–259 Apparatus, Golgi, 253–254 Apparel, drapes and protective, 97–98 Applications bioelectrodes, 654–655 EO sterilization, 757–758 ophthalmological, 583–591 orthopedic, 526–555 of scaffolds, 737–740 in vivo, 97–99 Approaches variational, 36 weighted residual, 36 Arms, linker, 692–694 Arrays, neuronal electrode, 808 Arrhythmias, cardiac, 483–485 Artery stents, coronary, 476–479 Arthroplasty mold, 529–531 total hip replacement, 531–532 Arthroplasty, history of total hip, 529–532 femoral head prostheses, 531 long-stem prostheses, 531 mold arthroplasty, 529–531 short-stem prostheses, 531 total hip replacement arthroplasty, 531–532 Artifacts, 280 Artificial devices; See Bioartificial devices Artificial endothelium, 588 Artificial epithelium, epikeratophakia and, 587–588 Artificial heart, total implantable, 489 Artificial heart valves, 38–40, 798–799 Artificial organs, 709–748 extracorporeal, 514–526 immunoisolation, 728–734 overview of tissue engineering, 712–728 synthetic bioresorbable polymer scaffolds, 735–747 Artificial prosthesis, 712 Artificial red blood cell substitutes, 507–514 hemoglobin, 507 modified hemoglobin, 507–511 perfluorochemicals, 511–512 Assay methods, 357–359 agar diffusion test, 358 direct contact test, 357–358 elution test, 358 interpretation of results, 358–359 Assays, new solid-phase materials for ligand binding, 686–692 miscellaneous biosensor strategies, 691–692 molecularly imprinted surfaces, 690–691 particles, 686–689 self-assembled monolayers, 690 surface-enhanced spectroscopies, 691 Assessment, key considerations for BMI, 370–373 blood-factors affecting its properties, 370–371 blood interaction times, 373 how flow affects blood interactions, 371–372 properties of biomaterials and devices, 373 surfaces, 373 Assist cardiac, 486–490 kidney, 514–518 lung substitutes and, 524 Assist devices implantable cardiac, 494–503 ventricular, 487–489 Assurance Act, Biomaterials Access, 796 ASTM F67, 148 ASTM F75, 146 ASTM F90, 147 ASTM F136, 149 ASTM F562, 147–148 ASTM F799, 147 Atherosclerotic vascular disease, 476–483 Atomic structure, 25 Atopy, 331 Attachment, tissue, 154–155 Attack complex, membrane, 322 Auditory system, overview of, 658–659 Authorship, 795 B Background concepts, 237–288 adsorbed proteins in tissue response to biomaterials, 237–246 cells and cell injury, 246–260 mechanical forces on cells, 282–287 tissues and cell-biomaterial interactions, 260–281 Bacterial adhesion to surfaces, 347 Behavior, elastic, 27 Bioactive glasses and glass-ceramics, 160–163 Bioactive molecules, delivery of, 732 Bioartificial devices, 525 Bioceramics characteristics and processing of, 155–157 types of, 154–155 Biocompatibility, 809–810 and medical device performance, 765–766 of pyrolytic carbon, 177–179 standards, 786–787 Biocompatibility testing, ISO standard for, 791–792 Biodegradable polymers, 79 Biodegradation, hydrolytic, 412–416 host-induced hydrolytic processes, 413–414 hydrolysis-preclinical and clinical experience, 414–416 structures of hydrolyzable polymers, 412–413 Biodegradation, oxidative, 416–427 device- or environment-mediated oxidation, 421–425 direct oxidation by host, 418–421 oxidation reaction mechanisms and polymer structures, 416–418 oxidative degradation induced by external environment, 425–427 Bioelectrodes, 649–656 applications, 654–655 electrode-electrolyte interface, 650–651 electrode materials, 653 equivalent circuit models, 651–652 factors influencing material selection, 652–653 Bioerodible materials, bioresorbable and, 115–127 applications of synthetic degradable polymers as, 121–125 currently available degradable polymers, 116–121 definitions and process of erosion and/or degradation, 116 Bioerosion factors influencing rate of, 124–125 process of, 123 Biofilm control, novel engineering approaches to, 349 Biofilm formation on surfaces, 347–349INDEX 833 Biofilm microbiology, 346–347 bacterial adhesion to surfaces, 347 biofilm formation on surfaces, 347–348 natural control of biofilm formation on surfaces, 348–349 novel engineering approaches to biofilm control, 349 Biofilm-resistant biomaterials, 349–352 control of microbial colonization of biomaterials, 351 delivery of biofilm control agents, 351–352 testing for antibacterial and antibiofilm properties, 349–351 Biofilms, biomaterials and device-related infections, 345–353 Biological effects of surface microtexture, 222–224 Biological environment corrosion and corrosion control in, 434–437 degradation of materials in, 411–453 influence of, 434 Biological fluids, properties of, 813–817 Biological properties assessed by in vivo tests, specific, 366–368 Biological response to materials, water and, 63–64 Biological stimuli, smart gels that respond to, 112 Biological testing of biomaterials, 359–409 evaluation of BMIs (blood-materials interactions), 371–383 large animal models in cardiac research testing, 383–396 large animal models in vascular research testing, 383–396 microscopy for biomaterials science, 396–409 in vitro assessment of tissue compatibility, 360–364 Biology; See Microbiology; pathobiology Biomaterial corrosion, orthopedic, 541–543 Biomaterial, silk as, 807–808 Biomaterial wear, orthopedic, 540–541 Biomaterials adsorbed proteins in tissue response to, 235–244 allergy and, 334 biological testing of, 359–409 composition and characteristics of adhesive, 576–581 and device-related infections, 349–357 and glucose sensing meet photonics, 805–806 importance of adsorbed proteins in, 245 inflammatory reaction to, 293–294 lack of pure and safe natural, 806 orthopedic, 528, 539–553 role of water in, 59–64 synthetic degradable polymers and, 121–125 tissue-derived, 317–318 tissue engineering using scaffold, 709 Biomaterials Access Assurance Act, 797 Biomaterials, biofilm-resistant, 349–352 control of microbial colonization of biomaterials, 351 delivery of biofilm control agents, 351–352 testing for antibacterial and antibiofilm properties, 349–351 Biomaterials components, kinetics and nature of, 328–329 Biomaterials design, orthopedic, 524 Biomaterials, diagnostics and, 685–697 ligand immobilization on solid phases, 692–695 solid phase immunoreagents, 695–696 solid-phase materials for ligand binding assays, 686–692 Biomaterials, ethical issues in development of new, 793–795 animal experimentation, 794 authorship, 795 clinical trials, 793–794 industrial support for research, 794–797 patents, 796–797 regulation, 795–796 Biomaterials, history of, 10–19 biomaterials before World War II, 10–12 contemporary era, 18–19 designed biomaterials, 17–18 modern biology and modern materials, 18–19 post World War II, 12–17 surgeon/physician hero, 12–17 Biomaterials, host reactions to, 293–350 biofilms, biomaterials and device-related infections, 345–353 blood coagulation and blood-materials interactions, 332–336 complement system, 318–328 immune response to foreign materials, 304–318 infection, 295–296 inflammation, wound healing and foreign-body response, 296–304 inflammatory reaction to biomaterials, 293–294 innate and adaptive immunity, 304–318 systemic and remote effects, 294–295 systemic toxicity and hypersensitivity, 328–332 thromboembolic complications, 295 tumorigenesis, 295 tumorigenesis and biomaterials, 338–345 Biomaterials, legal aspects of, 797–804 artificial heart valves, 799–800 Biomaterials Access Assurance Act, 803 defensive manufacturing and marketing, 804 intrauterine devices, 798–799 liability of design engineers, 803 pacemakers, 800 pedicle screws, 800–801 preemption, 802 science in courtrooms, 802–803 silicone breast implants, 801–802 Biomaterials, polymeric, 78–79 biodegradable polymers, 79 copolymers, 79 Biomaterials science, correlation, surfaces and, 765–771 aspects of bioreaction to biomaterials, 767 biocompatibility and medical device performance, 765–766 case for correlation, 767–769 correlation, 766–767 data, information, and statistics, 766 issues complicating simple correlation, 769 multivariate correlation, 769–770 Biomaterials science, microscopy for, 396–409 configurations, 396–397 digital imaging, 404–406 fluorescence microscopy, 398–404 light microscopy, 397–398 magnification, resolution, and contrast, 396 Biomaterials science - multidisciplinary endeavor, 1–9 biomaterials and biomaterials science, 1–2 biomaterials literature, 9 biomaterials societies, 9 characteristics of biomaterials science, 4–6 examples of biomaterials applications, 2–4 subjects integral to biomaterials science, 6–9834 INDEX Biomaterials science, perspectives and possibilities in, 805–829 biocompatibility, 809–810 biomaterials and glucose sensing meet photonics, 805–806 circulating endothelial progenitor cells, 809 dental materials, 809 DNA technologies, 807 ethics, 810 gene expression analysis, 808 lack of pure and safe natural biomaterials, 806 miscellaneous stem cells, 809 molecular imaging, 809 neuronal electrode arrays, 808 novel elastic and smart biopolymers, 808 self-assembled materials, 806 silk as biomaterial, 807–814 Biomaterials, tumorigenesis and, 338–345 implants with human and animal tumors, 339–341 pathobiology of foreign body tumorigenesis, 341–344 Biomechanics, examples from, 37–40 Biomedical sensors and biosensors, 670 Biomedical specialists, challenges to, 760 Biomolecules, surface-immobilized, 225–233 immobilization methods, 227–230 Biopolymers, novel elastic and smart, 813 Bioprosthetic heart valve calcification, 443–444 Bioresorbable and bioerodible materials, 115–127 applications of synthetic degradable polymers, 121–125 currently available degradable polymers, 116–121 definitions and process of erosion and/or degradation, 116 Bioresorbable polymer scaffolds, synthetic, 735–749 applications of scaffolds, 737–740 cell seeding and culture in 3D scaffolds, 745–746 characterization of processed scaffolds, 745 scaffold design, 735–736 scaffold materials, 736–737 scaffold processing techniques,740–744 Biosensor strategies, miscellaneous, 691–692 Biosensors, 679–683 background, 680 sensing modalities, 680–683 Biosensors, biomedical sensors and, 670 biocompatibility, 673–674 biosensors, 679–683 classes of sensors, 674–679 consuming versus nonconsuming sensors, 671–672 duration of use, 672–673 interaction of sensor with its environment, 671 micrototal analytical systems, 682 physical versus chemical sensors, 670 sensors in modern medicine, 670 site of measurement, 672 Biosynthetic machinery, 253–254 Biotextiles, medical fibers and, 86–100 applications, 95–99 drapes and protective apparel, 95–99 medical fibers, 87–94 processing and finishing, 94 testing and evaluation, 94–95 topical and percutaneous applications, 97 in vivo applications, 97–99 Bladders, polymeric, 440–441 Bleeding, 505–506 Blood; See also Plasma/blood Blood cell substitutes, artificial red, 507–514 hemoglobin, 507 modified hemoglobin, 507–511 perfluorochemicals, 511–512 Blood coagulation and blood-materials interactions, 332–338 biofilm microbiology, 346–349 coagulation, 334 control mechanisms, 336–338 mechanisms of coagulation, 334–336 platelets, 332–334 Blood compatibility defined, 367 measuring, 367–368 Blood contacting materials, 495–498 Blood interactions, how flow affects, 371–372 Blood-materials interactions, blood coagulation and, 332–338 coagulation, 334 control mechanisms, 336–338 mechanisms of coagulation, 334–336 platelets, 332–334 Blood pumps for chronic circulatory support, 502–505 polymeric bladders in, 440–441 Blood vessels, 720 BMI assessment, key considerations for, 370–373 blood-factors affecting its properties, 370–371 blood interaction times with materials and devices, 373 how flow affects blood interactions, 371–372 properties of biomaterials and devices, 373 surfaces, 373 BMI evaluation, contemporary concepts in, 377–378 BMIs (blood-materials interactions), 367 BMIs (blood-materials interactions), evaluation of, 367–379 blood compatibility, 367 contemporary concepts in BMI evaluation, 377–378 evaluation of BMIs, 374–377 key considerations for BMI assessment, 370–373 measuring blood compatibility, 367–368 thrombogenicity, 368–370 in vitro tests of BMIs, 374–375 in vivo evaluation of devices, 376–377 in vivo tests of BMIs, 375–376 Bonding covalent, 23–24 fiber, 741 ionic, 23 metallic, 24–25 weak, 25 Bone, 719 Braids, 95 Breast implants, 441–442 Breast implants, silicone, 801–802 Brittle fracture, 29 Burn dressings and skin substitutes, 602–614 advances in burn treatment, 602 permanent skin substitutes, 609–613 temporary skin substitutes, 605–609 wound coverage and healing, 602–605 wound coverage and skin substitutes, 604–605 C Cadavers, allografts from, 605–606 Calcification, pathological, 439–451 assessment of biomaterials calcification, 440–442 pathologic biomaterials and medical device calcification, 440–442 pathophysiology, 444–448 prevention of calcification, 448–451 Calcified tissues, structure and properties of, 528–529 Calcium phosphate ceramics, 162–165 coatings, 165–166 Calcium phosphates, resorbable, 166 Canine, 381–386INDEX 835 Carbon elemental, 169 pyrolytic, 38, 168–180 Carbon, biocompatibility of pyrolytic, 177–179 Carbon components, steps in fabrication of pyrolytic, 173–177 Carbon fibers, 182 Carcinogenesis, 551–552 Cardiac arrhythmias, 483–485 Cardiac assist and replacement devices, 486–490 cardiopulmonary bypass, 486–487 complications of cardiac assist devices, 489–490 IABPs (intraaortic balloon pumps), 487 total implantable artificial heart, 489 ventricular assist devices, 487–489 Cardiac assist devices, complications of, 489–490 Cardiac assist devices, implantable, 494–507 blood contacting materials, 495–498 clinical need and applications, 494–495 complications and VAD biocompatibility issues, 498–502 rotary blood pumps for chronic circulatory support, 502–505 VADs (ventricular assist devices), 495–498 Cardiac pacemakers, 483–485 Cardiovascular devices, miscellaneous, 490–491 Cardiovascular implants, 777–778 Cardiovascular medical devices, 470–494 atherosclerotic vascular disease, 476–483 cardiac assist and replacement devices, 486–490 miscellaneous cardiovascular devices, 490–491 pacemakers and ICDs, 483–485 stents and grafts, 476–483 substitute heart valves, 472–476 Cartilage, 718–719 Cataracts, introduction to, 587–588 Cell-biomaterial interactions, 260–281 Cell housekeeping, normal, 246–248 Cell injection method, 713 Cell injury and regeneration, 255–256 Cell-matrix interactions, 265 Cell-mediated disease, pathogenesis of, 314–317 Cell regenerative capacity, 273–274 Cell responses to mechanical forces, vascular, 282–285 Cell seeding and culture in 3D scaffolds, 745–746 miscellaneous culture conditions, 746 profusion culture, 746 rotary vessel culture, 746 spinner flask culture, 745–746 static culture, 745 Cell specialization and differentiation, 255 Cell/tissue-biomaterials interactions, 272–275 Cell transplantation, 737–738 Cells, 732 allografts of cultured, 606 circulating endothelial progenitor, 809 combined with synthetic membranes, 608 endothelial, 462 identification, genotyping, and functional assessment of, 280 miscellaneous stem, 809 red, 338 white, 338 Cells and cell injury, 246–260 apoptosis, 258–259 biosynthetic machinery, 253–254 causes of cell injury, 256–257 cell injury and regeneration, 255–256 cell specialization and differentiation, 255 cellular integrity and movement, 251–252 cytoskeleton, 251–252 energy generation, 254–255 Golgi apparatus, 253–254 lysosomes and proteasomes, 254 mitochondria, 254–255 necrosis, 258 normal cell housekeeping, 246–248 nucleus-central control, 252–253 pathogenesis of cell injury, 257 plasma membrane, 248–251 responses to cell injury, 257–258 rough and smooth ER (endoplasmic reticulum), 253–254 waste disposal, 254 Cells and tissues, techniques for analyses of, 276 artifacts, 280 electron microscopy, 279–280 identification and functional assessment of cells, 280 light microscopy, 277–279 synthetic products in cells or tissue sections, 280 three-dimensional interpretation, 280 Cells, mechanical forces on, 282–287 skeletal cell responses to mechanical forces, 285–287 vascular cell responses to mechanical forces, 282–285 Cells or tissue sections, synthetic products in, 280 Cellular integrity and movement, 251–252 Cellular interactions, adhesion proteins and, 238–240 Centrifugal plasma separation, 519–520 Ceramic degradation, 437–438 Ceramics, degradation effects on, 430 ceramic degradation, 437–438 corrosion and corrosion control, 434–437 influence of biological environment, 434 Ceramics, glasses and glass-ceramics, 153–168 bioactive glasses and glass-ceramics, 159–162 calcium phosphate ceramics, 162–165 calcium phosphate coatings, 165–166 characteristics and processing of bioceramics, 155–157 clinical applications of HA (hydroxyapatite), 166 nearly inert crystalline ceramics, 157–158 porous ceramics, 158–159 resorbable calcium phosphates, 166 types of bioceramics, 154–155 Ceramics; See also Bioceramics; glass-ceramics, 25, 183, 534–535 calcium phosphate, 162–165 nearly inert crystalline, 157–158 porous, 158–159 Cervical spine, finite element model for lower, 37–38 Chemical compositions of metals used for implants, 822–823 Chemical degradation, mechanisms of, 123–124 Chemical sensors, 676–679 Chemical sensors, physical versus, 670 Chemically controlled delivery systems, 633–638 Chromium alloys; See Cobalt-chromium alloys Chronic inflammation, 299–304 Classical pathway, 319–320 Clinical applications of HA (hydroxyapatite), 166 Clinical correlates, 325–327 Clinical trials, 793–794 of unapproved devices, 790–791836 INDEX Closed-mold processes, 186 Closed-system method, 713 Coagulant activity, platelet, 334 Coagulation, 334 Coagulation, blood, 332–338 biofilm microbiology, 346–349 coagulation, 334 control mechanisms, 336–338 mechanisms of coagulation, 334–336 platelets, 332–334 Coagulation, mechanisms of, 334–336 Coatings calcium phosphate, 165–166 conversion, 212 enteric, 640 new alloys and surface, 537–539 parylene, 212–213 Cobalt alloys, new, 538–539 Cobalt-based alloys, 145–149 Cobalt-chromium alloys, 536–537 Cochlear prostheses, 658–669 directions for future, 667 materials and electrode arrays, 661–666 overview of auditory system, 658–659 Collagen allografts of cultured cells and, 606 biological consequences of, 132–134 chemical modification of, 132–134 graft copolymers of, 136 native structure of, 130–132 structure of native, 128–130 Collagen and elastin, 262–265 calcification of, 448 Colorants, 622–623 Compatibility; See also Biocompatibility blood, 367 measuring blood, 367–368 in vitro assessment of tissue, 356–360 in vivo assessment of tissue, 360–367 Complement receptors, 324–325 Complement system, 318–328, 337–338 AP (alternative pathway), 320–322 classical pathway, 319–320 clinical correlates, 325–327 complement receptors, 324–325 control mechanisms, 322–324 future directions, 327 lectin pathway, 320 membrane attack complex, 322 Complexation hydrogels, 105 Complications, thromboembolic, 295 Components kinetics and nature of biomaterials, 328–329 steps in fabrication of pyrolytic carbon, 173–177 Composites, 180–196 absorbable matrix, 190 continuous fiber, 186–187 fracture fixation, 190–193 matrix systems, 183–184 mechanical and physical properties of, 186–190 particulate, 189–190 reinforcing systems, 182–183 short-fiber, 189 total joint replacement, 193 Composites, fabrication of, 184–186 fabrication of fiber-reinforced composites, 184–186 fabrication of particle-reinforced composites, 184 Composition, surface, 56–57 Compression molding, 742 Concepts, background, 237–288 adsorbed proteins in tissue response to biomaterials, 237–246 cells and cell injury, 246–260 mechanical forces on cells, 282–287 tissues and cell-biomaterial interactions, 260–281 Configurations, testing of materials/design, 762–763 Consensus standards, voluntary, 783–788 biocompatibility standards, 786–787 standards, 783–784 users of standards, 784–785 writers of standards, 785–786 Constants, elastic, 28 Consuming versus nonconsuming sensors, 671–672 Consumption, platelet, 56–57, 334 Contact-angle correlations, 57 Contact angle methods, 44–45 Contact lenses, 583–587 flexible perfluoropolyether lenses, 586 general properties, 583–584 rigid, 586–587 soft, 442 soft hydrogel, 584–586 Contact profilometry, 220 Continuous fiber composites, 186–187 Continuum equations, 35–36 Control, novel engineering approaches to biofilm, 349 Conversion coatings, 212 Copolymers, 74, 79 Cornea, 715 Corneal implants; See also Intracorneal implants, 587–589 Corneas, plastic, 589 Coronary artery stents, 476–479 Correlates, clinical, 325–327 Correlation, surfaces and biomaterials science, 765–771 issues complicating simple correlation, 769 multivariate correlation, 769–770 Correlations contact-angle, 57 issues complicating simple, 769 multivariate, 769–770 Corrosion crevice, 436 fretting, 436 galvanic, 436–437 intergranular, 436 metallic, 432–434 orthopedic biomaterial, 542–544 pitting, 435 Corrosion cracking, stress, 436 Courtrooms, science in, 802–803 Covalent bonding, 23–24 Cracking, stress corrosion, 436 Creep and viscous flow, 30–31 Crevice corrosion, 436 Crystalline ceramics, nearly inert, 158–159 Crystallinity, 73 Culture profusion, 746 rotary vessel, 746 spinner flask, 745–746 static, 745 Culture conditions, miscellaneous, 746 Culture in 3D scaffolds, cell seeding and culture, 745–746 Cytapheresis, 523–524 Cytoskeleton, 251–252 D DDS (drug delivery systems), 628–648 chemically controlled delivery systems, 633–638 diffusion-controlled delivery systems, 628–631 enteric coatings, 640 nucleic acid delivery systems, 640 particulate systems, 642–645 polymer therapeutic delivery systems, 642 regulated delivery systems, 641–642 in situ gelling delivery systems, 638 in situ precipitating delivery systems, 638 water penetration-controlled delivery systems, 631–633 Defense mechanisms, adverse effects of, 329–330INDEX 837 Defensive manufacturing and marketing, 804 Deformation, plastic, 29–30 Degradable medical implants, classification of, 121–123 Degradable polymers and biomaterials, synthetic, 121–125 Degradable polymers, currently available, 116–121 poly(amino acids), 119–121 pseudo-poly(amino acids), 119–121 Degradation ceramic, 437–438 definitions and process of erosion and/or, 116 mechanisms of chemical, 123–124 Degradation studied by SIMS, poly(glycolic acid), 57 Degradative effects on metals and ceramics, 430–439 ceramic degradation, 437–438 corrosion and corrosion control, 434–437 influence of biological environment, 438 Delivery systems chemically controlled, 633–638 diffusion-controlled, 628–631 nucleic acid, 640 polymer therapeutic, 642 regulated, 641–642 in situ gelling precipitating, 638 in situ precipitating, 638 water penetration-controlled, 631–633 Dental implantation, 555–572 clinical environment, 567–569 currently used implant modalities, 559–566 general aspects of packaging and preparation, 570 history, 555–559 tissue interfaces, 566–567 trends in research and development, 569–570 Dental implants, orthopedic and, 779–780 Dental materials, 809 Dentistry, application of materials in medicine and, 455–707 adhesives and sealants, 572–583 dental implantation, 555–572 extracorporeal artificial organs, 514–526 strategies to lower thrombogenicity of metals, 466 use of endothelial cells and RGD peptides, 466 Deposition, LB (Langmuir-Blodgett), 208–209 Design orthopedic biomaterials, 528 scaffold, 735–736 Design configurations, testing of materials, 762–763 Design engineers, liability of, 803 Development of new biomaterials, ethical issues in, 793–797 animal experimentation, 794 authorship, 795 clinical trials, 793–794 industrial support for research, 794–797 patents, 796–797 regulation, 795–796 Development, role of implant retrieval in device, 776–777 Device development, role of implant retrieval in, 776–777 Device failure, implant and, 760–765 biological testing of implants, 763 clinical handling and surgical procedure, 764 design, 762 packaging, shipping, and storage, 764 patient/user, 764 raw materials, fabrication, and sterilization, 763–764 testing of materials/design configurations, 762–763 Devices bioartificial, 525 changes to regulated medical, 792–793 clinical trials of unapproved, 790–791 immunologic toxicity of medical, 327 intrauterine, 798–799 miscellaneous cardiovascular, 490–491 sterilization of implants and, 754–760 ventricular assist, 487–489 in vivo evaluation of, 372–373 Devices, implantable cardiac assist, 494–507 blood contacting materials, 495–498 clinical need and applications, 494–495 complications and VAD biocompatibility issues, 498–502 VADs (ventricular assist devices), 495–498 Diagnostics and biomaterials, 685–697 ligand immobilization on solid phases, 692–695 solid phase immunoreagents, 695–696 solid-phase materials for ligand binding assays, 686–692 Dialysis, 514–518 Differential formulation, 35 Digital imaging, 404–406 Direct contact test, 357–358 Diseased tissues or organs, metabolic products of, 712 Diseases atherosclerotic vascular, 476–483 pathogenesis of cell-mediated, 314–317 valvular heart, 472–476 Diseases, pathogenesis of antibody-mediated, 313–314 antibody bound to cell surfaces or fixed tissue antigens, 313–314 IC (immune complex)-mediated injury, 314 IgE-mediated (immediate hypersensitivity), 313 Dislocation, total hip, 37 Disposal, waste, 252 Distribution, mw (molecular weight), 509 DNA technologies, 807 Drapes and protective apparel, 96–97 Dressings burn, 602–614 hydrocolloid, 608 Diffusion-controlled delivery systems, 628–631 E ECM (extracellular matrix), 262–265 adaptor/adhesive molecules, 265 amorphous matrix, 265 collagens and elastin, 262–265 GAGs (glycosaminoglycans), 265 proteoglycans and hyaluronan, 265 Ectodermal derived tissue, 714–716 Elastic behavior, 27 Elastic constants, 28 Elasticity, 29 Elastin, 136 calcification of collagen and, 448 collagens and, 262–265 Elastomers, silicone, 82–84 cross-linking by addition, 83 cross-linking by condensation, 82–83 cross-linking with radicals, 82 elastomer filler, 83–84 Electrodes; See also Bioelectrodes Electrode arrays, neuronal, 808 Electrode-electrolyte interface, 650–651 electrical double layer, 650–651 faradaic and nonfaradaic processes, 650 polarizable and nonpolarizable electrodes, 650 Electron beam sterilization, 759 Electron microscopy, 279–280, 406–408 elemental analysis in SEM, 408 focused ion beam instruments, 408838 INDEX Electron microscopy (Continued) low-voltage imaging, 408 SEM (scanning electron microscopy), 404–408 variable pressure and ESEM, 408 Electron spectroscopy for chemical analysis (ESCA), 45–46 Electrospinning, 88–89 Element analysis, finite, 32–40 continuum equations, 35–36 examples from biomechanics, 37–40 finite element equations, 36–37 overview of finite element method, 33–35 surface analysis techniques, 42–56 Element equations, finite, 36–37 Elemental carbon, 169 Elution test, 358 Embolism; See Thromboembolism Encapsulation, concept of, 728 Encapsulation, fibrosis/fibrous, 302–304 Endoderm, 716–718 Endothelial cells and RGD peptides, 466 Endothelial progenitor cells, circulating, 808 Endothelium, artificial, 587 Energy generation, 252–253 Engineering, applications of tissue, 714–722 ectodermal derived tissue, 714–716 endoderm, 716–718 mesoderm, 718–722 Engineering, overview of tissue, 712–728 applications of tissue engineering, 714–722 future perspectives, 722 lost tissue or organ function, 712–728 replacing lost tissue or organ function, 713–714 Engineering, superstructure, 742 Engineers, liability of design, 803 Enteric coatings, 640 Environment corrosion control in biological, 434–437 degradation of materials in biological, 411–453 influence of biological, 434 nature of plasma, 206 Environmental SEM (ESEM), 408 EO sterilization, 757–758 advantages and disadvantages, 758 applications, 758 EO residuals issues, 758 process and mechanism of action, 757 Epikeratophakia and artificial epithelium, 587–588 Epithelium, epikeratophakia and artificial, 587–588 Equations continuum, 35–36 finite element, 36–37 ER (endoplasmic reticulum), rough and smooth, 253–254 Erosion and/or degradation, definitions and process of, 116 Erosion; See also Bioerosion ESCA (electron spectroscopy for chemical analysis), 45–46 ESEM (Environmental SEM), 408 Etching, reactive plasma and ion, 219 Ethical issues in development of new biomaterials, 793–797 animal experimentation, 794 authorship, 795 clinical trials, 793–794 industrial support for research, 794–797 patents, 796–797 regulation, 795–796 Ethics, 810 Evaluation, contemporary concepts in BMI, 377–378 Events, molecular spreading, 242–245 Examples from biomechanics, 37–40 Experimentation, animal, 794 Extracellular matrix and cell-biomaterial interactions, 260–281 remodeling, 272 Extracorporeal artificial organs, 514–526 apheresis, 518–524 bioartificial devices, 525 development of extracorporeal artificial organs, 525 kidney assist, 514–518 lung substitutes and assist, 524 Extrusion, 742–743 Eye, introduction to optics of, 591–592 F Fabrication, effect on strength, 32 Fabrics, woven, 92–94 Failure, heart, 486–490 Failure, implant and device, 760–765 biological testing of implants, 763 clinical handling and surgical procedure, 764 design, 762 packaging, shipping, and storage, 764 patient/user, 764 raw materials, fabrication, and sterilization, 763–764 testing of materials/design configurations, 762–763 Fatigue, 31 Femoral head prostheses, 531 Fiber bonding, 741 Fiber selection, polymer and, 89–90 Fibers absorbable synthetic, 90 carbon, 182 hybrid bicomponent, 91–92 modified natural, 90–91 polymer, 182–183 Fibers, medical, 86–100, 87–94 absorbable synthetic fibers, 90 hybrid bicomponent fibers, 91–92 modified natural fibers, 90–91 synthetic fibers, 87–90 Fibers, synthetic, 87–90 electrospinning, 88–89 melt spinning, 87–88 polymer and fiber selection, 89–90 wet spinning, 88 Fibrinolysis, 333 Fibrinolytic agents, immobilization of, 466 Fibrosis/fibrous encapsulation, 202–304 Filament-winding process, 186 Filtration, membrane plasma, 522–523 Finite element analysis, 32–40 Finite element equations, 36–37 Finite element method, overview of, 33–35 Fixation, fracture, 190–193 Flask culture, spinner, 745–746 Flow, creep and viscous, 30–31 Fluids, properties of biological, 813–817 Fluorescence microscopy, 398–404 Foreign-body reaction, 301–302 Foreign-body response, 296–304 Foreign body tumorigenesis, pathobiology of, 341–344 Foreign materials, immune response to, 304–318 Formation; See also Deformation Formation on surfaces, natural control of biofilm, 348–349 Formulations differential, 35 variational, 35–36 Fractionation, sorption plasma, 519 Fracture, brittle, 29 Fracture fixation, 190–193 Freeze-drying, 742 Fretting corrosion, 432 Functions IOLs with variations of optical, 597–599 properties of interpolating, 36–37 replacing lost tissue or organ, 713–714 Functions, therapeutic approaches for lost tissue or organ, 712 artificial prosthesis, 712INDEX 839 metabolic products of diseased tissues or organs, 712 surgical reconstruction, 712 transplantation, 712 G GAGs (glycosaminoglycans), 134–136, 263 Galvanic corrosion, 436–437 Gas foaming (GF), 743 Gas processes, miscellaneous, 205–206 Gene expression analysis, 808 Generation, energy, 254–255 Genotoxicity, 362–363 GF (gas foaming), 744 Glass-ceramics, bioactive glasses and, 159–162 Glass-ceramics, ceramics, glasses and, 153–168 bioactive glasses and glass-ceramics, 159–162 calcium phosphate ceramics, 162–165 calcium phosphate coatings, 165–166 characteristics and processing of bioceramics, 155–157 clinical applications of HA (hydroxyapatite), 166 nearly inert crystalline ceramics, 157–158 porous ceramics, 158–159 resorbable calcium phosphates, 166 types of bioceramics, 154–155 Glasses, 183 bioactive, 159–162 inorganic, 25–26 Glasses and glass-ceramics, ceramics, 153–168 bioactive glasses and glass-ceramics, 159–162 calcium phosphate ceramics, 162–165 calcium phosphate coatings, 165–166 characteristics and processing of bioceramics, 155–157 clinical applications of HA (hydroxyapatite), 166 nearly inert crystalline ceramics, 157–158 porous ceramics, 158–159 resorbable calcium phosphates, 166 types of bioceramics, 154–155 Glaucoma, implants for, 589–590 Glucose sensing meet photonics, biomaterials and, 805–806 Glycosaminoglycans (GAGs), 134–136, 265 Glycosaminoglycans, graft copolymers of, 136 Golgi apparatus, 253–254 Graft copolymers of collagen, 136 Graft copolymers of glycosaminoglycans, 136 Grafts; See also Allografts; xenografts peripheral stents and stent, 479 stents and, 476–483 vascular, 479–483 Granulation tissue, 300–301 Groups, polymers containing hydrolyzable pendant, 416 H HA (hydroxyapatite), clinical applications of, 166 Hard-tissue adhesives, 579–580 Healing, wound, 296–304 Healing, wound coverage and, 602–604 Heart disease, valvular, 472–476 Heart failure, 486–490 Heart, total implantable artificial, 489 Heart valve calcification, pathophysiology of bioprosthetic, 447–448 Heart valves, 440, 720–721 artificial, 38–40, 799–800 substitute, 472–476 HeartMate, 497–498 Hemoglobin; See also Polyhemoglobin Hemoglobin, miscellaneous types of soluble modified, 508–509 Hemoglobin, modified, 507–511 miscellaneous types of soluble modified hemoglobin, 508–509 mw (molecular weight) distribution, 509 polyhemoglobin, 507–508 second-generation hemoglobin blood substitutes, 510–511 third-generation blood substitutes, 511 in vitro biocompatibility screening test, 509–510 Hemoperfusion, 518 Heparin, ionically bound, 462–465 Heparin, thrombin inhibition without, 465 Heparinization, 462 Hierarchies, testing, 390–392 High-molecular-weight kininogen (HMWK), 336 Hip arthroplasty, history of total, 529–532 femoral head prostheses, 531 long-stem prostheses, 531 mold arthroplasty, 529–531 short-stem prostheses, 531 total hip replacement arthroplasty, 531–532 Hip dislocation, total, 37 Hip replacement arthroplasty, total, 531–532 HMWK (high-molecular-weight kininogen), 336 Host reactions to biomaterials, 293–354 biofilms, biomaterials and device-related infections, 345–353 blood coagulation and blood-materials interactions, 332–338 complement system, 318–328 immune response to foreign materials, 304–318 infection, 295–296 inflammation and wound healing, 296–304 inflammatory reaction to biomaterials, 293–294 innate and adaptive immunity, 304–318 systemic and remote effects, 294–295 systemic toxicity and hypersensitivity, 328–332 thromboembolic complications, 295 tumorigenesis, 295 tumorigenesis and biomaterials, 338–345 Human and animal tumors, implants with, 339–341 Human plasma/blood, 505–506 Hyaluronan, proteoglycans and, 265 Hybrid bicomponent fibers, 91–92 Hydrocolloid dressings, 608 Hydrogel contact lenses, soft, 584–586 Hydrogels, 100–107 applications, 104–106 classification and basic structure, 100–101 complexation, 105 complexing, 104 determination of structural characteristics, 103 intelligent or smart, 103–104 pH-sensitive, 103, 105 preparation, 101–102 properties of important biomedical, 103 swelling behavior, 102–103 temperature sensitive, 104 temperature-sensitive, 105 Hydrolysis-preclinical and clinical experience, 414–416 poly(alkyl cyanoacrylates), 416 polyamides, 415–416 poly(ester urethanes), 415 polyesters, 414–415 polymers containing hydrolyzable pendant groups, 416840 INDEX Hydrolytic biodegradation, 412–416 host-induced hydrolytic processes, 413–414 hydrolysis-preclinical and clinical experience, 414–416 structures of hydrolyzable polymers, 412–413 Hydrolyzable pendant groups, polymers containing, 416 Hydrophilic effect, 61–62 Hydrophobic effect, 60–61 Hypersensitivity and immunotoxicity, 330 systemic toxicity and, 328–332 I IABPs (intraaortic balloon pumps), 487 ICDs (implantable cardioverter-defibrillators), 485 ICDs, pacemakers and, 479–481 Imaging digital, 404–406 low-voltage, 408 molecular, 809 Immune response to foreign materials, 304–318 Immune responses, pathology associated with, 311–317 pathogenesis of antibody-mediated disease, 313–314 pathogenesis of cell-mediated disease, 314–317 Immunity innate and adaptive, 304–318 recognition and effector pathways in adaptive, 307–311 recognition and effector pathways in innate, 306–309 types of adaptive, 309 Immunoisolation, 728–734 applications, 733 challenge of, 728–729 Immunoisolation, devices for, 729–733 cells, 732 matrices, 732 membranes, 731–732 Immunologic toxicity of medical devices, 327 Immunoreagents, solid phase, 695–696 Immunotoxicity, hypersensitivity and, 326 Implant and device failure, 760–765 biological testing of implants, 763 design, 762 packaging, shipping, and storage, 764 patient/user, 764 raw materials, fabrication, and sterilization, 763–764 testing of materials/design configurations, 762–763 Implant modalities, currently used, 559–566 Implant retrieval and evaluation, 771–780 approach to assessment of host, 774–776 components of implant retrieval and evaluation, 773–774 goals, 772–773 implanting responses, 774–776 role of implant retrieval in device development, 776–777 useful information learned from implant retrieval, 777–780 Implant retrieval and evaluation in research, 753 correlation, surfaces and biomaterials science, 765–771 implant and device failure, 760–765 implant retrieval and evaluation, 771–780 sterilization of implants and devices, 754–760 Implant retrieval, role of, 775–776 Implant retrieval, useful information learned from, 777–780 Implantable artificial heart, total, 489 Implantable cardioverter-defibrillators (ICDs), 485 Implantation, dental, 555–572 clinical environment, 567–569 currently used implant modalities, 559–566 general aspects of packaging and preparation, 570 history, 555–559 tissue interfaces, 566–567 trends in research and development, 569–570 Implantation, ion beam, 207–208 Implants biological testing of, 757 breast, 441–442 cardiovascular, 771–772 chemical compositions of metals used for, 823–824 classification of degradable medical, 121–123 corneal, 587–589 for glaucoma, 589–590 with human and animal tumors, 339–341 pyrolytic carbon for long-term medical, 168–180 for retinal detachment surgery, 589 silicone breast, 801–802 Implants and devices, sterilization of, 754–760 challenges to biomedical specialists, 760 EO sterilization, 757–758 miscellaneous sterilization processes, 759–760 overview of sterilization methods, 756 radiation sterilization, 758–759 steam sterilization, 754–757 sterility as a concept, 754–755 sterilization process development and validation, 755–756 Implants, intracorneal, 588 Implants, intraocular lens, 589 biomaterials for IOLs, 592–597 emerging functional variations of IOLs, 592 future of IOLs, 599–600 introduction to cataracts, 591–592 introduction to intraocular lens implants, 591–592 introduction to optics of eye, 591–592 IOLs with variations of optical function, 597–599 successfulness of IOLs, 592 Implants, steps in fabrication of, 138–141 metal-containing ore to raw metal product, 138–139 raw metal product to stock metal shapes, 139 stock metal shapes to final metal devices, 139–141 stock metal shapes to preliminary metal devices, 139–141 Imprinted surfaces, molecularly,690–691 In situ gelling and in situ precipitating delivery systems, 638 In situ polymerization, 739–740 In vitro assessment of tissue compatibility, 356–360 assay methods, 357–359 background concepts, 356–357 clinical use, 359–360 historical overview, 356 new research directions, 360 In vitro biocompatibility screening test, 509–510 In vitro tests, 786–787 of BMIs, 370–371 In vivo applications, 97–99 evaluation of devices, 376–377 long-term testing, 787 In vivo assessment of tissue compatibility, 360–367 biomaterial and device perspectives in in vivo testing, 361–362INDEX 841 perspectives on in vivo medical device testing, 365–366 selection of animal models for in vivo tests, 364–365 specific biological properties assessed by in vivo tests, 362–364 in vivo tests according to intended use, 361 In vivo medical device testing, perspectives on, 365–366 In vivo testing, short-term, 787 In vivo tests of BMIs, 375–376 selection of animal models for, 364–365 specific biological properties assessed by, 362–364 Induction, tissue, 737 Industrial support for research, 794–797 Inert crystalline ceramics, nearly, 158–159 Inert materials, 457–462 albumin coating and alkylation, 459–460 Infections, 295–296, 500–501 biofilms, biomaterials and device-related, 345–351 Inflammation acute, 298–299 chronic, 299–304 wound healing and foreign-body response, 296–304 Inflammatory reaction to biomaterials, 293–294 Infrared spectroscopy (IRS), 50–51 Inhibition, steric, 695 Injection method, cell, 713 Injury, cells and cell, 246–260 apoptosis, 258–259 biosynthetic machinery, 253–254 causes of cell injury, 256–257 cell injury and regeneration, 255–256 cell specialization and differentiation, 255 cellular integrity and movement, 251–252 cytoskeleton, 251–252 energy generation, 254–255 Golgi apparatus, 253–254 lysosomes and proteasomes, 254 mitochondria, 254–255 necrosis, 258 normal cell housekeeping, 246–248 nucleus-central control, 252–253 pathogenesis of cell injury, 257 plasma membrane-protection, 248–251 responses to cell injury, 257–258 rough and smooth ER (endoplasmic reticulum), 253–255 waste disposal, 254 Injury, tissue response to, 272–274 cell regenerative capacity, 273–274 extracellular matrix remodeling, 274 inflammation and repair, 272–273 Innate and adaptive immunity, 304–318 Innate immunity, recognition and effector pathways in, 306–309 Inorganic glasses, 25–26 Interactions blood coagulation and blood-materials, 332–338 cell-biomaterial, 260–281 cell-matrix, 265 cell/tissue-biomaterials, 274–277 Interfaces, electrode-electrolyte, 650–651 Intergranular corrosion, 432 Interpolating functions, properties of, 36–37 Interpretation, three-dimensional, 280 Intraaortic balloon pumps (IABPs), 487 Intracorneal implants, 588 Intraocular lens implants, 589 biomaterials for IOLs, 592–597 emerging functional variations of IOLs, 592 future of IOLs, 599–600 introduction to cataracts, 591–592 introduction to intraocular lens implants, 591–592 introduction to optics of eye, 591–592 IOLs with variations of optical function, 597–599 successfulness of IOLs, 592 Intraocular lenses, contamination of, 57 Intraocular lenses (IOLs), 592 Intrauterine contraceptive devices (IUDs), 442 Intrauterine devices, 798–799 IOLs (intraocular lenses), 591–602 accommodative, 598–599 adjustable power, 599 biomaterials for, 592–597 emerging functional variations of, 592 future of, 605 monofocal toric, 597 multifocal, 597–598 phakic, 598 successfulness of, 592 with variations of optical function, 597–599 yellow-tinted blue blocking, 599 Ion beam implantation, 207–208 Ion etching, reactive plasma and, 219 Ionic bonding, 23 IRS (infrared spectroscopy), 50–51 ISO standard for biocompatibility testing, 791–792 Isolation; See Immunoisolation Isotropy, 28 IUDs (intrauterine contraceptive devices), 442 J Joint replacement, total, 193 K Kidney assist, 514–518 Kinetics and nature of biomaterials components, 328–329 Knits, 94–95 L Lamina, macromechanics of, 187–188 Laminates, macromechanics of, 188–189 Large animal models in cardiac research testing, 379–396 in vascular research testing, 379–396 LB (Langmuir-Blodgett) deposition, 208–209 Lectin pathway, 320 Legal aspects of biomaterials, 797–804 artificial heart valves, 799–800 Biomaterials Access Assurance Act, 803 defensive manufacturing and marketing, 804 intrauterine devices, 798–799 liability of design engineers, 803 pacemakers, 800 pedicle screws, 800–801 preemption, 802 science in courtrooms, 802–803 silicone breast implants, 801–802 Lens implants, intraocular, 589 biomaterials for IOLs, 592–597 emerging functional variations of IOLs, 592 future of IOLs, 605 introduction to cataracts, 591–592 introduction to intraocular lens implants, 591–592 introduction to optics of eye, 591–592 IOLs with variations of optical function, 597–599 successfulness of IOLs, 592 Lenses contamination of intraocular, 57 flexible perfluoropolyether, 586 soft contact, 442 soft hydrogel contact, 584–586842 INDEX Lenses, contact, 583–587 flexible perfluoropolyether lenses, 586 general properties, 583–584 rigid contact lenses, 586–587 soft hydrogel contact lenses, 584–586 Liability of design engineers, 803 LIGA (lithography, electroplating, molding), 219 Ligand binding assays, materials for, 686–692 miscellaneous biosensor strategies, 691–692 molecularly imprinted surfaces, 690–691 particles, 686–690 self-assembled monolayers, 690 surface-enhanced spectroscopies, 691 Ligand immobilization on solid phases, 692–695 linker arms, 692–694 photolinking, 694–695 steric inhibition, 695 Light microscopy, 277–279, 397–398 Linker arms, 692–694 Liver, 710 Long-stem prostheses, 532 Long-term testing in vivo, 787 Lost tissue or organ function, replacing, 713–714 Low-voltage imaging, 408 Lower cervical spine, finite element model for, 37–38 Lung substitutes and assist, 524 Lysosomes and proteasomes, 254 M Macromechanics of lamina, 187–188 of laminates, 188–189 Manufacturing, defensive, 804 Marketing, defensive manufacturing and, 804 Materials bioresorbable and bioerodible, 115–127 blood contacting, 495–498 bulk properties of, 23–32 dental, 809 immune response to foreign, 304–318 methods for modifying surfaces of, 203–213 organ rejection and response to synthetic, 317–318 scaffold, 736–737 self-assembled, 806 water and biological response to, 63–64 Materials, classes used in medicine, 66–232 natural materials, 127–137 polymers, 66–78 Materials, degradation of, 411–453 degradation of polymers, 411–430 degradative effects on metals and ceramics, 430–439 pathological calcification of biomaterials, 439–451 Materials/design configurations, testing of, 762–763 Materials, important properties of, 31–32 effect of fabrication on strength, 32 fatigue, 31 toughness, 32 Materials, inert, 457–462 albumin coating and alkylation, 459–460 Materials market, orthopedic, 527–529 Materials, mechanical properties of, 26–28 elastic behavior, 27 elastic constants, 28 isotropy, 28 shear, 27 stress and strain, 27 tension and compression, 27 Materials, methods for modifying surfaces of chemical reaction, 203 conversion coatings, 212 high-temperature and high-energy plasma treatments, 206 ion beam implantation, 207–208 laser methods, 213 LB (Langmuir-Blodgett) deposition, 208–209 multilayer polyelectrolyte absorption, 210–211 nature of plasma environment, 206 parylene coatings, 212–213 production of plasma environments for deposition, 206 radiation grafting and photografting, 203–205 RFGD plasma depositing gas processes, 205–206 RFGD plasmas for immobilization of molecules, 206 SAMs (self-assembled monolayers), 209–210 silanization, 206–207 SMAs (surface-modifying additives), 211–212 Materials, natural, 127–137 biological consequences of collagen, 132–134 chemical modification of collagen, 132–134 elastin, 136 GAG (proteoglycans and glycosaminoglycans), 134–136 graft copolymers of collagen, 136 graft copolymers of glycosaminoglycans, 136 physical modification of collagen,
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