Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices
اسم المؤلف
Kayvon Modjarrad, MD, PhD, Sina Ebnesajjad, PhD
التاريخ
26 نوفمبر 2023
المشاهدات
232
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(لا توجد تقييمات)
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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
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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