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أخواني في الله أحضرت لكم كتاب Handbook of Polymer Applications in Medicine and Medical Devices Edited by Kayvon Modjarrad, MD, PhD Chief, Respiratory Disease Vaccine Development, United States National Institutes of Health Sina Ebnesajjad, PhD President, FluoroConsultants Group, LLC
![كتاب Handbook of Polymer Applications in Medicine and Medical Devices H_b_o_35](https://i.servimg.com/u/f61/15/36/74/14/h_b_o_35.jpg) و المحتوى كما يلي :
Table of contents Preface Author Biographies 1. Introduction 1.1 History 1.2 A Historical Example 1.3 Anthology Architecture 1.4 Summary References 2. Application of Plastics in Medical Devices and Equipment 2.1 Device Industry Overview 2.2 Health-care Trends 2.3 From Legacy Materials to Advanced Specialty Polymers for Devices 2.4 Driving Trends Leading to New Material Requirements 2.5 Market Factors Affecting the Industry 2.6 Conclusion 3. Plastics Used in Medical Devices 3.1 Plastic Compositions 3.2 Medical Devices—Material Selection Process 3.3 Common Medical Device Polymers 3.4 Summary References 4. Polymeric Biomaterials 4.1 Introduction 4.2 Polymeric Biomaterials in Ophthalmology 4.3 Polymeric Biomaterials in Orthopedics 4.4 Polymeric Biomaterials in Cardiovascular Diseases 4.5 Polymeric Biomaterials for Wound Closure 4.6 Polymeric Biomaterials in Extracorporeal Artificial Organs 4.7 Polymeric Biomaterials for Nerve Regeneration 4.8 Conclusions and Future Outlook References 5. Biofilms, Biomaterials, and Device-Related Infections 5.1 Introduction 5.2 Bacterial Biofilms 5.3 Biofilm Microbiology and Infectious Disease 5.4 Device-Related Infection 5.5 Clinical Examples of Biofilm Infections 5.6 Prevention and Treatment 5.7 Conclusions References 6. Adhesives for Medical and Dental Applications 6.1 Introduction 6.2 Natural Adhesives 6.3 Synthetic and Semisynthetic Adhesives 6.4 Cyanoacrylic Adhesives 6.5 Test Methods to Characterize Strength of Tissue Adhesives 6.6 Medical and Dental Applications of Adhesives 6.7 Bone Adhesives 6.8 Dental Applications of Adhesives References 7. Silicones 7.1 Chemical Structure and Nomenclature 7.2 Conclusion Acknowledgments Bibliography 8. Review of Research in Cardiovascular Devices 8.1 Introduction 8.2 The Heart Diseases 8.3 The Cardiovascular Devices in Open-Heart Surgery 8.4 The Minimally Invasive Cardiology Tools 8.5 The Technology for Atrial Fibrillation 8.6 Minimally Invasive Surgery 8.7 The Minimally Invasive Valve Implantation 8.8 Support Technology for Surgery Planning 8.9 Conclusions 8.10 Acknowledgments References 9. Endotracheal Tube and Respiratory Care 9.1 Introduction 9.2 Properties of the Endotracheal Tube 9.3 Endotracheal Tubes and Other Airway Adjuncts 9.4 Proper Safeguarding of the Airway 9.5 Maintenance of the Endotracheal Tube 9.6 Respiratory Therapies for the Intubated Patient 9.7 Conclusions 9.8 Clinical Pearls References 10. Applications of Polyaryletheretherketone in Spinal Implants: Fusion and Motion Preservation 10.1 Introduction 10.2 Origins of Interbody Fusion and the “Cage Rage” of the Late 1990s 10.3 CFR-PEEK Lumbar Cages: The Brantigan Cage 10.4 Threaded PEEK Lumbar Fusion Cages 10.5 Clinical Diagnostic Imaging of PEEK Spinal Cages and Transpedicular Screws 10.6 Subsidence and Wear of PAEK Cages 10.7 Posterior Dynamic Stabilization Devices 10.8 Cervical and Lumbar Artificial Discs 10.9 Summary Acknowledgments References 11. Microbubble Applications in Biomedicine 11.1 Introduction 11.2 Microbubbles for Ultrasound Imaging 11.3 Targeted Microbubbles 11.4 Microbubbles in Drug and Gene Delivery 11.5 Microbubbles in Gene Delivery 11.6 Other Emerging Applications 11.7 Conclusion References 12. Hydrogels in Regenerative Medicine 12.1 Introduction: Relevance of Hydrogels to Regenerative Medicine 12.2 Background and Theory 12.3 Utility in Regenerative Medicine 12.4 Applications of Hydrogels in Regenerative Medicine 12.5 Prospects and Conclusions References 13. Biodegradable Polymers 13.1 Introduction 13.2 Biodegradable Polymer Selection Criteria 13.3 Biologically Derived Polymers 13.4 Synthetic Polymers 13.5 Combinations (Hybrids) of Synthetic and Biologically Derived Polymers 13.6 Using Polymers to Create Tissue-Engineered Products 13.7 Conclusion References 14. Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview 14.1 History and Introduction 14.2 United States Regulations 14.3 ISO 13485 (European and Global Standard) 14.4 Other Countries 14.5 Global Harmonization Task Force (GHTF) 14.6 Applicability of the Regulations to Material Suppliers 14.7 Conclusion References Index Index Note: Page numbers followed by “f ”, “t ”, and “b” refer to figures, tables, and boxes, respectively. A Abdominoplasty, 119 AbioCor, 156 Acoustic wave propagation, 258259 4-Acryloyloxyethyl trimellitate anhydride (4-AETA), 123 Adhesives, uses cyanoacrylate adhesives benefits and limitations of, 106t polymerization reaction of, 105f cyanoacrylate monomers, structures of, 104f cyanoacrylic adhesives, 104110 medical/dental applications, 111119 in medicine and dentistry, 103104 natural adhesives, 104 for skin closure, 112 suture and tissue, 112114 synthetic/semisynthetic, 104 tissue adhesives, case studies of, 112119 Aintree intubation catheter, 199f Airway evaluation difficult airway, predicting, 200201 esophageal bulb detector, 201f esophageal intubation, detection, 201203 homemade syringe device, 201f identifying proper position, 201206 supraglottic devices, 200f Airway exchange catheters, 199f, 210 Airway resistance, 196 algC, 8081 Alkoxysilane, 136137 Anterior lumbar interbody fusion (ALIF), 236 Antibiofilm properties, of biomaterials, 8991 Antibiotics, bioelectric effect, 9294 Appendectomies, 11 Appropriate depth, confirmation of, 203204 Artificial heart, 154155 Artificial organs RoboticallyAssisted surgery (AORobAS) system, 184185, 184f Aryloxyphosphazenes, 321 Asclepiades, 192 ASTM Method E 2196-02, 91 Atactic polypropene, 23 Atrial fibrillation, technology, 174175 cryoablation, 175 laser ablation, 175 microwave ablation, 175 radiofrequency used in ablation, 174175 ultrasound ablation, 175 Audible cuff leak, evaluation, 204205 Autoclave sterilization, 35, 41 Automated endoscopic system for optimal positioning (AESOP) disadvantages for, 181 robots replacing, 178 Zeus system, 180181 Automatic tube compensation (ATC), 217218 Avalve, simplest configuration of, 166f B Bacterial adherence, 8587 Bacterial biofilms extracellular polymeric substance, 78 in orthopedic prosthetic joint infection, 8789 phenotypic heterogeneity, 78 on surgical mesh, 87 on sutures, 8587 Bacterial counts, for contaminated lacerations, 113t Bacterial infection, 266 Bacteriostatic behavior, 113 Baekeland, Leo, 3f Bagby and Kuslich (BAK) technique, 233 Balloon angioplasty, 172173 Balloon valvotomy, 164 Basic local alignment search tool (BLAST), 8485 Berlin heart, 158 Berlin Heart Excor, 160161 Biodegradable polymers, 33, 303305 biologically derived polymers, 305314 design/development of, 303 selection criteria, 304305 Bioelectric effect, 9293 to antibiotics, 9294 treating S. epidermidis, 9293 Biofilm bacteria, 78 cell-cell communication, 78 resistance of, 79 Biofilm destruction, 266 Biofilm development, key processes, 78f Biofilm formation nucleic acid-based detection methods, 8485 orthopedic screws, 84f processes of, 8081 by staphylococci, 8283 Biofilm infected sutures, 86f Biofilm infections clinical examples of, 8589 surgical repair materials, 85 Biofilm microbiology bacterial adhesion, to surfaces, 7980 biofilm formation, processes of, 8081 infectious disease, 7981 Biofilm-resistant biomaterials, prevention/ treatment, 8994 Biofilm structure, adaptation of, 7879 Bioinspiration, 94 Biologically derived polymers, 305314, 323 alginate, 312 aliphatic polyesters, 315319 copolymers, 315318 poly(glycolic acid), 315318 poly(lactic acid), 315318 barriers, 324325 biodegradable polyurethanes, 319320 biomimetic materials, 310 cellulose, 311 347Biologically derived polymers (Continued) chitosan, 313 collagen, 305307 elastin, 308 gelatin, 307308 gellan gum, 312 gels, 325 glycosaminoglycans (GAGs), 312313 hybrids of, 323 in vitro, 307 keratin, 308309 lactide enantiomers, 316f matrices, 325 peptides and proteins, 305310 poly(amide carbonate), 322f poly(amino acids), 321323 polyanhydrides, 320321 poly(ε-caprolactone) (PCL), 318, 318f polyhydroxyalkanoates (PHA), 313314 polynucleotides, 314 poly(orthoesters), 319, 319f poly(p-dioxanone) (PDS), 318 polyphosphazenes, 321 polysaccharides, 310313 proteins uses, as degradable biomaterials, 306t proteoglycans (PGs), 309310 ‘pseudo’-poly(amino acids), 321323 segmented poly(urethane), general structure of, 320f silk, 309 starch, 311312 synthetic polymers, 314323 widely investigated polysaccharides, 306t Biomaterials antibiofilm properties of, 8991 microbial colonization control, 9192 polymeric. See Polymeric biomaterials resist bacterial attachment/biofilm formation, 9394 surfaces, biofilm control agents, 92 Biomedicine, microbubble applications. See Microbubble applications, in biomedicine Biomimicry, 94 Bioresorbable polymer, 37 Biotinlylated microbubble targete to streptavidin-coated surface, 261f Bisphenol A (BPA), 1718 Blalock-Taussig (B-T) shunt, 185 Blood pump support, in palliative surgery study, 185 B-16 melanoma tumors, 263 Bone adhesives, 119 characteristics of, 120t development of, 119 Bone glue, 119 Bone regeneration scaffold, 324f Bronchodilators, inhaled, 219 Bronchospasm, 220 Butyl cyanoacrylate, 107108 N-Butyl-2-cyanoacrylate, 110 Bypass system aortic connector, 176 C Cannot intubate, cannot ventilate (CICV), 210 Capnography yields quantifiable measurements, 201202 CarboMedics, 170 Carbon fibers, 29 Carcinogenesis, 33 Cardiac devices, evolution, 146t Cardiac surgery, 151, 181182 Cardiopulmonary bypass (CPB), 66 Cardiopulmonary resuscitation (CPR), 201 Cardiovascular devices artificial heart, 154155 schematic diagram, 154f blood pumps, 151162 in open-heart surgery, 151171 POLTAH design process, steps, 153f William Kolff, in Kampen, 155f Cardiovascular surgeons, 11 Carel’s techniques, 45 Carpentier-Edwards pericardial valve, 169170 Carpentier-Edwards PERIMOUNT pericardial bioprosthesis, 170 Carpentier-Edwards prostheses, 167 Catheter-lock solutions (CLS), 82 CE marking declaration, 342f Cell microencapsulation, schematic of, 286f Center for Biofilm Engineering (CBE), 80 Central Drugs Standards Control Organization (CDSCO), 344 Central nervous system (CNS), 67 Centrifugal pumps, 152153 Chemical sterilants, 43 Chest physiotherapy, 215216 high-frequency chest wall compression, 216 intrapulmonary percussive ventilation (IPV), 216 percussion/postural drainage, 216 positive end-expiratory pressure therapy, 216 Coatings, 9293 Coefficient of friction (COF), 26 Collagen, 305307 adhesives, 104 advantageous properties, 307 in vitro, 307 in vivo, 307308 Colorimetric capnometric device, 203f Comparative tracking index (CTI), 31 Complete airway management (CAM), 214 Compression molding, 139 Computational fluid dynamics (CFD), 171 Confocal microscopy, 8990 Continuous positive airway pressure (CPAP), 217 Conventional endoscopic instruments, 181 Coronary artery bypass graft (CABG) surgery, 1011 Coronary artery disease, 176 Cryoablation, 175 Crystalline polymers, 49 Cuff pressure monitoring, 204 Cyanoacrylate monomer, 104105 Cyanoacrylates, 105, 115116 polymerization of, 106 tissue adhesives, 104105 benefits and limitation, 106t commercial grades, 109110 cured loctite, typical performance of, 107t manufacturers of, 109 medical grade, 107109 topical adhesives, 116 Cyanoacrylic acid butyl ester, 112 Cyclic di-GMP, 9192 Cystic fibrosis (CF) lung, 79 Cytotoxicity, 33 D da Vinci S model, 182 Delrin disk, 168169 Denaturing gel gradient electrophoresis (DGGE), 8485 Dental adhesives, 119120 applications, 119124 capability of, 120 ingredients of, 122t methacrylic acid (MA), 121122 resin monomers, 121 Derjaguin, Landau, Verwey, and Overbeek (DLVO) theory, 7980 Dermabond (2-octylcyanoacrylate), 110 Device-related infection, 8185 biofilm formation, 81 detection, 8384 surgical repair materials, 85 Dielectrophoresis, 287 Double-lumen endotracheal tube (DLT), 199 Dry heat sterilization, 43 Dynesys, 242243 E Edwards-Tekna valve, 168169 Eicosamethylnonasiloxane three-dimensional representation, 141f 348 INDEXElectrohydraulic artificial heart (EHTAH), 155156 Electromagnetic interference shielding (EMI), 29 EndoAssist, 181 Endothelial cells (ECs), 317318 Endotracheal tube (ETT), in medicine, 192 airway adjuncts, 195200 choice of, 195196 airway emergencies, rapid response cart, 209210 airway evaluation difficult airway, predicting, 200201 esophageal bulb detector, 201f esophageal intubation, detection, 201203 homemade syringe device, 201f identifying proper position, 201206 supraglottic devices, 200f airway resistance, 195196 American Society of Anesthesiologists difficult airway algorithm, 211f anatomy of, 192194 anticholinergics, 219220 automatic tube compensation, 217218 ballard closed endotracheal tube suctioning system, 213f biofilm accumulation, 214f biofilm management, 214215 bronchoscopy, 213214 clinical pearls, 221222 continuous positive airway pressure (CPAP), 217 corticosteroids, 220 cuff leaks, causes/solutions, 205t development/properties of, 194 difficult airway cart contents of, 212b double-lumen endotracheal tubes, 199200 heat and moisture exchanger, 212f inhalation antibiotics, 220 bronchodilators, 219 inhalation drug delivery, 218219 metered-dose inhalers, 218219 nebulizers, 218 intubated patient, respiratory therapies, 215221 chest physiotherapy, 215216 mucolytic agents, 215 secretion clearance, 215216 intubating laryngeal mask airway (ILMA) structural comparison of, 193f large tubes and trauma, 196 laser tubes, 197198 maintenance of, 210215 inspired gas, heat/humidity of, 210212 Mallinckrodt endobronchial tube, 198f, 199f overcoming work of, 217218 patient, positioning of, 220221 pilot balloon of, 193194 placement complications of, 195 physiologic effects of, 194195 potentially beneficial alternatives, 196200 preformed/reinforced tubes, 196197 pressure support, 217 proper position, identification, 201206 appropriate depth, 203204 audible cuff leak, 204205, 205t cuff pressure monitoring, 204 placement, documentation of, 205206 properties of, 192195 Rusch Lasertubus laser-safe endotracheal tube, 198f stabilization of, 206209 AnchorFast system, 209f commercially available devices, 209 emergency intubations, airway record for, 208f facial burns, stapling, 209 split-tape method, 208f taping, 206209 subglottic care, 213 subglottic suctioning evac endotracheal tubes, 198199 suctioning, 212213 supraglottic airways, 200 taperguard endotracheal tube cuff, 193f ventilator circuits, 217218 Endotracheal tube placement, 202b Enterococcus faecium, 110 Enzyme-linked immunosorbent array (ELISA), 8384 Escherichia coli, 110 Esophageal variceal bleeding, 115 Ester bond, of aliphatic polyesters, 315 Ethylene oxide (EtO), 31 resistance, 41 sterilization, 38 Exopolysaccharide (EPS) fibers, 7980 Extracellular bacterial DNA (eDNA), 79 Extracorporeal membrane oxygenation (ECMO), 152 F Facial burns, stapling, 209 Fatigue tests conventional standardized methods, 243 nanocrystalline diamond and steel coronary stents, 174f of PEEK rod systems, 243 Fiberoptic bronchoscopy to aid therapy, 195 use of, 213214 Fibrin, 111 Fibrin sealants, 104 Fibrinogen, 104, 111 Finger-printing method, 8485 Fluorescence, 28 Fluorescence in situ hybridization (FISH), 84f Foundation of cardiac surgery development (FCSD), 178179 G Gamma radiation resistance, 35, 37, 4041, 43, 46 Gastrointestinal (GI) endoscopy, 115116 bleeding from other sources, 115 closure of fistula, 115116 esophageal variceal bleeding, 115 gastric variceal bleeding, 115 peptic ulcer bleeding, 115 Gelatin hydrogels, 307308 Gelatine-resorcinol-formaldeyde (GRF), 104 Gellan gum, 312 Gene delivery, 264 Gene-activated matrix (GAM), 293 Generic-targeted microbubbles, 261262 Genetic testing, 12 Genotoxicity testing, 33 Glass transition temperatures, 141142 Glenn procedure, 185 Global harmonization task force (GHTF), 344 Glubran 2, 116 Glyceryl methacrylate (GMA), 5658 Glycosaminoglycans (GAGs), 312313 Gold marker lines, 173174 self-assembled monolayers (SAMs), 93 standard, resistance of biomaterials, 9091 Good Clinical Practice (GCP), 343 Good manufacturing practices (GMP), 337338, 343 critical devices, 338 quality assurance programs, 338 Good Quality Practice Ordinance (GQP) standards, 343 Green heart, 155156 H Health-care industry, 9 Health-care trends, 1012 alternate site treatment, 1112 minimally invasive surgeries, 1011 prevention vs. treatment, 12 Heart diseases, 150151 ischemic heart disease, 151 valvular heart disease, 151 Heart failure, congestive, 150151 INDEX 349Heart pacemaker, 171 Heart prostheses, 169f HeartSaver VAD, 158 Heart-lung machines, 151 Heat and moisture exchanger (HME), 210212 Heat shock protein (HSP) family, 287 Hemocompatibility, 33, 66 Hemolysis test, 165f Hexafluoropropylene (HFP), 65 High consistency rubber (HCR), 139 High-consistency silicone rubbers (HCRs), 136 High-density polyethylene (HDPE), 34 High-frequency chest wall compression, 216 High pressure, low volume (HPLV), 192193 ILMAs risky, 197 silicone ETTs, 192193 structural comparison of, 193f High volume and low pressure (HVLP) cuff, 192193, 197 Homopolymers, 3536 Homo sapiens, 145 Hospital acquired infections (HAIs), 12 Hydrogels, in regenerative medicine, 42, 279281 applications of, 290293 hydrogel parameters, effect of, 290t skin and wound healing, 290291 as biomaterials, 283284 cell association cell encapsulation, 285286 promoting cell attachment, substrates, 287290 schematic diagram of, 288f spatial patterning, 287 characterization of, 293 classification, 281 for controlled release, 284285 liver, 292 matrix-immobilized ligands, 289t and medical technology applications, 280t musculoskeletal, 291 neural regeneration, 291292 poly(ethylene oxide), 4t prospects, 293294 regenerative medicine, utility in, 282290 relevance of, 279281 reproductive medicine, 292293 theory, 281282 Hydroxy ethyl methacrylate (HEMA), 56, 123 of artificial heart, 154f homopolymer of, 123 hydrolysis of, 122123, 123f Hypoperfusion, 151 Hypoxemia, 212213 I IgG human antibodies, 79 Impact copolymers, 3536 Impact modifiers, 2728 Implant materials, in rats, 9192 Incor device, 161 Injection molding, 139 Interpenetrating polymer networks (IPNs), 60 dimethylacrylate, 285 poly(dimethylsiloxane) (PDMS), 60 poly(ethylene glycol) (PEG), 60 Intra-aortic balloon pump (IABP), 152153 Intraocular lenses (IOLs), 56 Intrapulmonary percussive ventilation (IPV), 216 Intubating laryngeal mask airway (ILMA) difficult airway cart, 212b structural comparison, 193f Investigational device exemption (IDE) clinical trial, 233 Investigational new animal exemptions (INAD), 340 Irritation tests, 33 Ischemic heart disease, 151 Isomers, 2224 geometric, 2223 stereosiomers, 2324 structural, 22, 22f Isotactic polypropene, 23 K Knotting instruments, 176 L Labile catalysts, 135 Lactide dimer to remove water molecule, 37 stereoisomeric structures of, 38f Laminar gas flow, 195196 Langerhans, for transplantation, 325 Laparoscopic, 176 Laryngeal structures, 196 Laryngoscopy, 210 Laser ablation, 175 Left ventricular assist devices (LVADs), 62 HeartMate II, 158 intermediate-to-chronic, 159160 short-term circulatory support, 161 Left ventricular assist system (LVAS), 160 Left ventricular opacification (LVO), 256 Linear low-density polyethylene (LLDPE), 13, 34 Lipopolysaccharide (LPS), 7980 Liquid crystalline polymer, 37 Liquid silicone rubber (LSR), 13, 139140 Low-density polyethylene (LDPE), 34 Lung cystic fibrosis (CF), 79 isolation, endobronchial blocking devices, 199f Lysine diisocyanate, 62 M Magnetic resonance imaging (MRI) machines, 21 Magnetic vascular positioner (MVP), 177 Mallampati score, 200201 Material suppliers, regulations applicability of, 345 Medical devices—material selection process chemical resistance, 31 common medical device polymers, 3449 electrical properties, 31 FDA device class, 29t joining and welding, 33 leachables and extractables, 3233 long-term durability, 3132 medical grade plastics, 33 physical and mechanical properties, 2930 shelf life and aging, 33 steam sterilization, effect of, 31f sterilization capability, 31 supplemental tests, 33 thermal properties, 31 USP classification, 30t Medical devices, USP classification of, 30t Medical plastic in common use, 4t development, timeline of, 2f device industry overview, 910 historical example, 45 plastics application, 9 Medical robotic systems, 178179 Medium density polyethylene (MDPE), 34 Medium vessels, sutureless anastomoses, 114 Medos-HIA VAD, 158 Medtronic intact, 170 Metered-dose inhalers (MDIs), 218 Methacrylate-based adhesives, use of, 111 Methacrylic acid (MA), 121122 10-Methacryloyloxydecyl dihydrogenphosphate (10-MDP), 123124 11-Methacryloyloxy-1, 10- undecanedicarboxylic acid (MAC-10) monomers, 124 4-Methacryloyloxyethyl trimellitic acid (4-MET), 123 350 INDEXMethicillin-resistant S. epidermidis (MRSE), 82 Methicillin-resistant Staphylococcus aureus (MRSA), 1819, 82, 8485 Methyl ester (methyl-2-cyanoacrylate), 105106 Methyl/ethyl cyanoacrylate adhesive, bond strength of, 108t Methyl methacrylate (MMA), 111, 122123 Microbial colonization control, biomaterials, 9192 Microbubble applications, in biomedicine biofilm destruction, 266, 266f canine heart, ultrasound image of, 260f components, 254f compression and rarefaction, 258f current clinical uses of, 259260 developmental history of, 253 emerging applications, 266268 Food and Drug Administration (FDA), 256257 in gene delivery, 264266 as drug carriers, 264266 gene delivery/drug, 262264 identification/quantification, 262 left ventricular opacification (LVO), 256 lymphosonography, 267268 magnetic resonance imaging, 267 microbubble-specific ultrasound modes, 259260 nanobubbles, 267 noninvasive pressure estimation, 266267 overview of, 253257 preparations table, 257t structure/function/use, table of, 255t targeting, 260262 active, 262 atherosclerosis, 262f biotinlylated microbubble, 261f ligand/receptor, 261262 timeline, 254f tissue engineering, 267 ultrasound contrast agent Targestar-B, frequency response of, 258f ultrasound imaging, interactions of, 257259 Microbubble cavitation, 263 Microbubble-assisted drug, gene delivery, 262264 Microbubble-based ultrasound contrast applications, 260 Micromolding, 16 Microwave ablation, 175 Mild tissue reaction, 114 Minimally invasive cardiology tools, 171174 Minimally invasive surgery (MIS), 151, 175185 CardioVations, 176 classical thoracoscopic tools, 176177 Coalescent Surgical, 176 coronary surgery, anastomotic devices for, 176 laparoscopic suturing, 176 Passport, 176 robot daVinci, 180f robots replacing, 178 Spyder device, 177 surgical robots, 177182 symmetry bypass system aortic connector, 176 Minimally invasive valve implantation, 185186 Ministry of Health, Labor, and Welfare (MHLW), 343 Mitral valve area (MVA), 162 Mitral valve, physical percutaneous balloon valvuloplasty simulation, 173f Mitral valve replacement (MVR), 167 heterograft tissue valves, 167 with mechanical prostheses vs. bioprostheses, 170171 Mitral valvuloplasty, hemodynamic improvement, 173 Monocyte, 293294 Motion preservation spine technology, 232233 Multi-locus strain typing (MLST), 80 Murphy eye, 192 Myocardial infarction (MI), 151 N Natural antibiofilm strategies, 91 Natural orifice transluminal endoscopic surgery (NOTES), 11 Natural polymers, 6162 Neoplasia, targeting, 261262 Nerve guidance, 68 Neuragen nerve guide, 292 Neural stem cells, proliferation of, 290 New animal drug applications (NADA), 340 Nexaband liquid, 113 Non-woven electrospun fibers, 284 Nucleic acid-based detection methods, 8485 N-vinyl-2-pyrrolidone (NVP), 56 O Octylcyanoacrylate, 108109 Octyl-2-cyanoacrylate (2-OCA), 108 Off-pump coronary artery bypass (OPCAB) anastomotic devices, 177 lateral wall grafting, 177 Oligo(polyethylene glycol) fumarate (OPF), 291 Organization of Pharmaceutical Safety and Research (OPSR), 343 Orthopedic implant infections, 8788 Orthopedic implant materials, 93 Orthopedic procedures, 11 Oxygen transmission hydrophilic monomers, 5658 silicone hydrogel lenses and conventional hydrogel lenses, 42 P P. aeruginosa, 8081 Pacemaker, 171 Parkes, Alexander, 3f Parylene, 47 coatings, 47 polymer molecules, structures of, 47f PennState LionHeart, 157 Peptic ulcer bleeding, 115 Percutaneous balloon dilation, 173 Percutaneous balloon valvuloplasty, 173 Percutaneous transluminal coronary angioplasty (PTCA), 172173 Percutaneous valve, 185186 Peripheral nervous system (PNS), 67 Permeant molecule, tortuous path of, 27f Pharmaceutical Affairs Law (PAL), 343 Pharmaceuticals and Medical Devices Agency (PMDA), 343 Photo-encapsulation, 286 Photopolymerization, 283 Pill Cam, 14 Pilot balloon repair device, 194f Pittsburgh-Thermo cardiosystems, 159160 Planktonic bacteria, 7980, 92 Plastic compositions, 2229 additives, 2529 antistats, 29 atactic polypropene, structure, 23f catalysts, 27 coupling agents, 28 impact modifiers, 2728 isomers, 2224 cis/trans-isomers, 23f geometric, 2223 structural, 22, 22f isotactic polypropene, structure, 24f linear/branched/crosslinked polymers, 22 molecular weight, 24 optical brighteners, 28 pigments/extenders/dyes/mica, 28 plasticizers, 28 polymer blends, 2425 polymer properties, 2224 radiation stabilizers, 28 reinforcing fillers, 2526 INDEX 351Plastic compositions (Continued) release agents, 26 slip additives/internal lubricants, 2627 stereoisomerism, 23 stereosiomers, 2324 syndiotactic polypropene, structure of, 24f thermal stabilizers, 28 tougheners, 2728 Plastics, in medical devices bisphenol A (BPA), 1718 compatibility, 1415 construction, commoditizing materials, 1516 diethyl hexyl phthalate (DEHP) plasticized PVC, 17 ecological/environmental concerns, 1617 energy costs, 18 functionality, 1314 global influences, 1819 economic pressures, 19 manufacturing, 18 markets, 18 SARS (severe acute respirator syndrome), 1819 light weighting, 15 market factors affecting, 1719 material costs/process improvements, 15 need for “green,” 18 technology innovations, 16 trends, 1317 Plastics production, timeline of, 2f Plastics, story, 23 Plastics suppliers Australia, 343344 CE marking declaration, 342f China, 343 European Union medical device directive, 341343 FDA 21 CFR Part 820, 339t FDA master files, 340 history, 337338 India, 344 ISO 13485, 340343, 341t Japan, 343 South America, 344 United States regulations, 338340 Plastic-to-rubber bonds, 106 Platelet additives, 26 Pneumatic pulsatile VADs, 160 Pneumatically driven artificial heart (POLTAH) artificial heart, schematic diagram of, 154f design process, 153f in vivo, 165f Pneumatically driven ventricular assist device (POLVAD) implantation, semiautomatic tools, 153f Polish ventricle assist devices, 158159 Pneumomediastinum, 219 Pneumoperitoneum, 219 Pneumothorax, 219 Polyamides (nylon), 4t Poly glycolic acid (PGA), 15, 66, 305, 315316 Poly(amino acids), 321 Polyaryletheretherketone (PEEK), 231232 applications. See Spinal implants, polyaryletheretherketone (PEEK) applications carbon fiber-reinforced (CFR), 233 Polyaryletherketone (PAEK) all-polymer articulations, 246 biomaterials, 231 Polybutadiene, 25 Polybutylene terephthalate (PBT), 24 Polycaprolactone (PCL) polymers, 15 Polycarbonate (PC), 4t, 24 steam sterilization, effect of, 31f Polydimethylmethylhydrogenosiloxane, 135 Polydimethylsiloxane (PDMS), 131132, 141 see also Silicone rubber Poly-p-dioxanone (PDS), 66 Polyester-based TPUs, 45 Polyether ether ketone (PEEK), 4344 applications and uses, 44, 46 EtO resistance, 43, 46 gamma radiation resistance, 43, 46 polymers, 13 rod system, 244f steam sterilization resistance, 4344 structure of, 43f Polyether imide (PEI), 13 PEI-DNA complexes, 288289 Polyethersulfone (PES), 41 Polyethylene (PE), 13, 34 polyvinyl chloride (PVC), 22 Poly(ethylene glycol) (PEG), 283 brushes, 255 interpenetrating polymer networks (IPNs), 60 Polyethylene terephthalate (PETE), 4t, 5, 13, 24, 62 Polyhydroxyalkanoates (PHA), 38, 313314 Poly(2-hydroxyethyl methacrylate) (PHEMA), 5658 Polyhydroxyhexanoate (PHH), 38 Polyhydroxyvalerate (PHV), 38 Polylactic acid (PLA), 15, 64, 315316 electron beam sterilization, effect of, 32f lactic acid, conversion of, 37f microbubbles, 265266 Poly(lactic-co-glycolic acid) (PLGA), 64 Poly-L-lysine, 285286 Polymerase chain reaction (PCR) detection techniques, 8485 Polymer-shelled microbubbles, 265266 Polymeric biomaterials applications of, 55 artificial cornea, 5860 in cardiovascular diseases, 6264 expanded PTFE, 6364 polyethylene terephthalate, 63 polyurethanes, 6263 for wound closure, 6466 common monomers, chemical structures of, 57f contact lens, 5658 extracorporeal artificial organs, 6667 glyceryl methacrylate (GMA), 5658 intraocular lens, 58 for IOLs, 59t natural polymers, 6162 for nerve regeneration, 6768 in ophthalmology, 5660 in orthopedics, 6062 polyacrylates, 61 polyethylene, 6061 Polymeric coatings, self-assembled monolayers (SAMs), 93 Polymers, 323 common medical device fluoropolymers, 4749 hydrogel (acrylate), 42 polyacrylate (acrylic, PMMA), 4142 polycarbonate, 3840 polyester, 3637 polyethersulfone, 41 polyethylene, 3435 polypropylene, 3536 poly-p-xylylene (Parylene), 47 polystyrene, 36 polysulfone (PSU), 4243 polyvinyl chloride, 4041 schematic of, 44f sterilization matrix of, 50t thermoplastic elastomers (TPE, TPU), 4446 thermoset elastomers—silicone, 46 devices, legacy materials, 1213 molecular weight, 24 natural, 6162 tissue-engineered products, 323325 Poly(methyl methacrylate) (PMMA), 4t, 56, 92 application of, 61 Polynucleotides, gene delivery, 314 Poly(p-dioxanone) (PDS), 318 Polypropylene (PP), 4t, 13 Polysaccharide teichoic acid fibers, 7980 352 INDEXPolysaccharides, 310311 Polysialic acid, 68 Polysiloxanes, structure, 46f Polystyrene (PS), 13, 25, 36 Polysulfone (PSU), structure of, 43f Polytetrafluoroethylene (PTFE), 3 chemical structure of, 49f gamma sterilization, effect of, 32f Poly(tetramethylene ether) glycol terephthalate (PTMG), 6566 Poly(tetramethylene ether terephthalate) copolymers of, 6566 Polyurethane (PU), 4t, 5960 bioresistant, 6263 mechanisms responsible for, 6263 physical percutaneous balloon valvuloplasty simulation, 173f Poly(vinyl alcohol) (PVA), 323 homopolymer of, 5960 Polyvinyl chloride (PVC), 5, 192 Polyvinylidene fluoride (PVDF), 65 Positive end-expiratory pressure therapy (PEEP) therapy, 216 Postanesthesia care unit (PACU), 204205 Posterior capsular opacification (PCO), 58 Posterior lumbar interbody fusion (PLIF), 233234 Premarket approval (PMA), 340 PressureEasy device, 204 Prostate specific antigen (PSA), 12 silicone PSAs, 140141 Proteoglycans (PGs), 309310 Pseudomonas aeruginosa, 110 Pulmonary artery axial blood pump, 185f Pulmonary artery stenosis, 173 Pulmonary toilet bronchoscopy, 213214 R Radiation sterilization, 38 Radiofrequency, 174175 Random copolymers, 3536 Rats, implant materials, 9192 Reproductive, 33 Restriction fragment length polymorphism (RFLP), 8485 Reverse transcriptase PCR (RT-PCR), 83 Rigid gas-permeable (RGP), 56 Risk management, 340 RNAIII-activating protein (RAP), 9192 RNAIII-inhibiting peptide (RIP), 9192 Robotic surgery, 146 Robotic systems, 178179 Robotics, potential applications of, 182 Room temperature vulcanization (RTV), 136137 elastomers, 140 Rubber-to-rubber bonds, 106 S S. epidermidis, 9293 Safe Medical Device Act (SMDA), 338 Schwann cells, 291292 Self-assembled monolayers (SAMs), 93, 93f Self-etch adhesives (SEAs), 120121 Severe acute respirator syndrome (SARS), 1819 Short-term circulatory support, 162171 Silicone elastomers, 138139 Silicone gel adhesives, 141 Silicone materials, 131 basic steps, 134t chemical structure/nomenclature, 131142 development, key milestones, 132t elastomers, 136140 cross-linking by addition, 137138 cross-linking by condensation, 136137 cross-linking with radicals, 136 filler, 138 processing of, 138140 silica network, 138f silicone film-in-place, 141 gels, 140 high consistency rubber (HCR), 139 historical milestones, 132 liquid silicone rubber (LSR), 139140 nomenclature, 132133 olymers, preparation, 133 physico-chemical properties, 141142 polycondensation, 133136 polymerization, 133136 silicone adhesives, 140141 bonding adhesives, 140 gel adhesives, 141 pressure-sensitive adhesives, 140 Silicone Shorthand Notation, 133t Silicone organic copolymers, 141 Silicone polymers, 136 Silicone preparation, catalyst removal, 135 Silicone rubber, 4t, 46 Single use disposables (SUDs), 12 Skin wrinkles, 308 Smooth muscle cells (SMCs), 317318 SonarMed airway monitoring device, 214 Sorin Bicarbon mechanical prosthesis, 170 Spinal cord injuries (SCIs), 292 Spinal implants, polyaryletheretherketone (PEEK) applications, 232f autograft-treated goats histological section of, 239f cervical/lumbar artificial discs, 244246 CFR-PEEK and CFR-PEKEKK cages, 235f lumbar cages, 233237, 234f transpedicular screw, 240f early pedicle-based systems, 242243 fused lumbar spinal segment, radiograph of, 239f fusion, 237f radiographic findings, 237f graf ligaments/dynesys, 242243 inflammatory reaction to CFR-PAEK, 237f interbody fusion and cage rage, 233 devices, 232f motion preservation spine technology, 232233 overview of, 231233 pedicle-based posterior stabilization rods, 242244, 243f, 244f PEEK spinal cages, clinical diagnostic imaging, 236f, 239240 PEEK-on-PEEK lumbar nucleus replacement (NUBAC), 245f posterior dynamic stabilization devices, 240244 interspinous process spacers, 241242 spacer, extension-limiting, 241f spinal fusions, incidence of, 232f subsidence/wear cages, 240 threaded PEEK interbody device, 238f lumbar fusion cages, 237238, 238f transpedicular screws, 239240 volumetric wear rates, comparison of, 246f Spyder device, 177 Stainless steel (SS) materials, 1415 Staphylococci, biofilm formation, 8283 Staphylococcus aureus, 110 Staphylococcus epidermidis adheres, 110, 112 biofilm, 214215, 266 Staphylococcus mucoidy, 81 Starfish2 heart positioner, 177 Starr-Edwards ball valve design, 168 State Food and Drug Administration (SFDA), 343 Steam sterilization resistance, 37, 41, 4344 Stentless bioprosthetic porcine aortic valves, 169170 Sterilization methods, 34 with hot air, 39 on parylene, 48t with peracetic acid, 39 resistance, 35 Subglottic suctioning, 213 Subharmonic-aided pressure estimation (SHAPE), 266267 Supraglottic airways, 200 Surgery planning medical applications, 187 INDEX 353Surgery planning (Continued) remote-control manipulators, 186 RobinHeart robot, 188f robots, 186 Syncardia systems, 155 Syndiotactic polypropene, 2324 Synthetic polymer, 5 T Taperguard endotracheal tube cuff, 193f Thermoplastic polyurethane elastomer, molecular structure, 45f Thoracoscopic surgery, 176 Thoratec PVAD (paracorporeal ventricular assist device), 158 Thrombin, 104 Ti-cron braided polyester suture, 86f Tissue adhesives characterize strength, test methods, 110 classification of, 121f dental applications, 119124 in gastrointestinal endoscopic procedures, 115116 bleeding from other sources, 115 closure of fistula, 115116 esophageal variceal bleeding, 115 gastric variceal bleeding, 115 peptic ulcer bleeding, 115 hernia incisions, closure of, 116119 open pediatric urological procedures, 114115 plastic surgery, uses, 119 potential cyanoacrylate pitfalls, 118t in topical skin wounds, 116 wound closure devices, 117t Tissue valves, 167 Tortuous path effect, 26 Total disc replacements (TDRs), 232233 Total endoscopic coronary artery bypass (TECAB), 177 Total joint replacement (TJR), 88 Tracheostomy tubes, pressure support, 217 Transfer molding, 139 U U-CLIP anastomotic device technology, 176177 Ultrahigh molecular weight polyethylene (UHMWPE) chains, 24 Ultra-low-density polyethylene (ULDPE), 34 Ultrasound ablation, 175 Unfixed biofilms, confocal microscope images of, 90f Unique identification (UID), for devices, 14 Urethane bond, 320 Urethanes, 45 Urinary catheters, 7778 V Valine-proline-glycine-valine-glycine (VPGVG) elastin repeat sequences, 310 Valve prostheses, 162171 Valve repair, 164 Valve test tester, 166f Valve-related problems, 168 bioprosthetic valves, 168 mechanical valves, 168 Valvular heart disease, 151, 162171 VEGFR2-targeted microbubble, 261262 Ventilator-associated pneumonia (VAP), 193 Ventilator circuits, pressure support, 217 Ventricular assist devices (VADs), 145 implantation, types of, 160161 Vinci S model, 182 Vinci telemanipulator, 181 Vision systems, 16 W Water uptake adversely influences, 123 Wistar rats, 116118 Wongworawat, 114 WorldHeart, 160 Wound bacterial counts, 113 Woven hydrogel/cell mixtures, 284 Y Young’s modulus, 316317 Z Zeus surgical system, 180
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