PEEK Biomaterials Handbook (Plastics Design Library)

Description

PEEK biomaterials are currently used in hundreds of thousands of spinal fusion patients around the world every year. Durability, biocompatibility, and excellent resistance to aggressive sterilization procedures make PEEK a polymer of choice, replacing metal in orthopedic implants, from spinal implants and knee replacements to finger joints and dental implants. The new edition of this authoritative work sees the book expand from 17 chapters to 26 chapters to match the expansion in applications in PEEK-from spinal cages to spinal rods and disc replacements; hip and knee joint replacement; dental; trauma; and sports medicine. New PEEK formulations have been developed incorporating hydroxyapatite, additives to combat infection, and surface grafted polymers to improve lubrication. The book also covers additive manufacturing, which has made significant inroads with PEEK in the past 5 years as well by introducing the prospect of patient-specific implants. Like the 1st edition, the updated Handbook brings together experts in many different facets related to PEEK clinical performance as well as in the areas of materials science, tribology, and biology to provide a complete reference for specialists in the field of plastics, biomaterials, medical device design, and surgical applications. Useful for materials scientists and biomedical engineers, both in industry and academia, the book is a one-stop shop for information on PEEK as a biomaterial-including in-depth coverage of materials properties-while also providing cutting-edge information on applications and combinations of the material.Presents a complete reference work covering PEEK, the leading polymer for spinal implants and a range of other biomedical applicationsCovers a range of new formulations and applications, including in-depth coverage of the additive manufacturing of PEEKProvides a vital source of supporting information for materials selection decisions and regulatory submissions Cover PLASTICS DESIGN LIBRARY (PDL) PDL HANDBOOK SERIES PEEK BIOMATERIALS HANDBOOK Copyright List of Contributors Foreword Part 1: PEEK Foundations, Properties, and Behavior 1 An Overview of PEEK Biomaterials Introduction What is a Polymer? What is PEEK? Crystallinity and PEEK Thermal Transitions PEEK Composites Overview of the Handbook References 2 Synthesis and Processing of PEEK for Surgical Implants Introduction Synthesis of PAEKs Nucleophilic Routes to PAEK polymers (Type 1) Electrophilic Routes to PAEK polymers (Type 2) Nomenclature Standards and Quality Systems for Production of Medical Grade Resin and Fabricated Forms Processing of Medical Grade PEEK Injection Molding Extrusion Compression Molding Film and Fiber Production Machining Summary References 3 Compounds and Composite Materials Introduction What Is a Composite Material? Role of the Matrix PEEK Polymer Matrix Role of the Fiber Carbon Fibers Role of the Fiber/Matrix Interface Powder Additive for Image Contrast Additive Geometry, Volume, and Orientation Effects Short CFR PEEK Continuous CFR PEEK Preparation of Materials Powder and Short Fiber Compounds-Extrusion Compounding Continuous CFR PEEK Processing to Make Parts Processing of Compounds Injection Molding Extrusion Barrel Temperatures Drive Motor Barrel Capacity and Residence Time Screw Design Processing of Continuous Fiber PEEK Composite Materials Hot Pressing and Autoclave Molding Pultrusion Filament Winding Hot Forming Composite Flow Molding High-Pressure Forming Machining Biocompatibility of CFR PEEK Summary and Conclusions References 4 Morphology and Crystalline Architecture of Polyaryletherketones Introduction Chain Architecture and Packing Polymer Backbone Morphology Crystal Unit Cells Crystallite Morphology Crystallization Behavior Characterization Techniques Density Gradient Technique X-Ray Scattering Wide Angle X-Ray (WAXS) Small Angle X-Ray (SAXS) FTIR Spectroscopy Differential Scanning Calorimetry (DSC) Microscopy Structure-Processing-Property Relationships Thermal Transitions Effects of Temperature on Structure and Properties Effects of Fillers on Structure and Properties Summary and Conclusions References 5 Fracture, Fatigue, and Notch Behavior of PEEK Introduction Fracture and Fatigue of Materials Stress Intensity Factor, K Impact Testing Stress-Life and Strain-Life Fatigue Testing Fatigue-Crack Propagation Notches PEEK Fracture Studies Mechanical Properties Fractography and Fracture Micromechanisms PEEK Stress-Life and Strain-Life Fatigue Studies PEEK Notch Studies Summary References Further Reading 6 Chemical and Radiation Stability of PEEK Introduction to Chemical Stability Water Solubility Thermal Stability Steam Sterilization of PEEK Radiation Stability: Implications for Gamma Sterilization and Postirradiation Aging Summary References 7 Additive Manufacturing of Polyaryletherketones Introduction, Additive Manufacturing and Polyaryletherketones Structure and Property Relationships in PAEKs Polyetheretherketone Polyetherketoneketone Powder Bed Fusion Processes Powder Bed Fusion Processes of PAEKs Examples of Commercially Available Machines for Powder Bed Fusion Processes of PAEKs Structure-Property Relationships and Powder Management in Powder Bed Fusion Processes Extrusion-Based Processes Extrusion-Based Processes of PAEKs Examples of Commercially Available Machines For Extrusion-Based Processes of PAEKs Structure-Property Relationships and Filament Management in Extrusion-Based Processes Summary References Part 2: Bioactive PEEK Materials 8 Biocompatibility of PEEK Polymers Introduction Cell Culture and Toxicity Studies Mutagenesis (Genotoxicity) Immunogenesis Soft Tissue Response Osteocompatibility of PEEK Devices Biocompatibility of PEEK Particulate-X-STOP PEEK Explant Studies Summary and Conclusions References Further Reading 9 Bacterial Interactions With PEEK Introduction Adhesion: The First Step to Infection Biomaterials and Infection Bacterial Adhesion to Biomaterials Bacteria: The Agents of Infection Bacterial Adhesion Mechanisms Nonspecific Adhesion Specific Adhesion The Role of Surface Topography and Chemistry in Bacterial Adhesion The Influence of Topography on Bacterial Adhesion The Influence of Surface Chemistry on Bacterial Adhesion Surface Chemistry and Protein Interactions Surface Chemistry and Bacterial Interactions The Role of the Host Immune Response in Biomaterial-Associated Infections Strategies to Reduce Bacterial Adhesion to PEEK Anti-adhesive Surfaces Antibacterial Surfaces Antibiotic Incorporation Into Biomaterials Silver Silver-PEEK Composites Summary and Perspectives References 10 Thermal Plasma Spray Deposition of Titanium and Hydroxyapatite on PEEK Implants Introduction Coating Technology Biomedical Plasma-Sprayed Coatings Coating Analysis Methods General Description of Analysis Methods Considerations in the Case of PEEK-Based Substrates Substrate Analysis Methods Plasma-Sprayed Coatings on PEEK-Based Substrates Technical Background Osseointegration Evidences Clinical Evidences Plasma-Sprayed Osteointegrative Surfaces for PEEK: The Eurocoating Experience Coating Characterization Substrates Characterization Summary and Conclusions References 11 Surface Modification Techniques of PEEK, Including Plasma Surface Treatment PEEK Tissue Interactions Surface Modification Biological Criteria Chemical Criteria Surface Analytical Assessment Surface Modification Techniques Direct-Physical/Chemical Flame Laser Corona Electron Beam Ion Beams Sputter Coating Hot Plasma Cold Plasma UV/Ozone Chemical Surface Modification Surface Etching Surface Grafting Applications of These Surface Modification Methods and the Translation to Industry Oxygen Plasma Surface Modification in Vitro Oxygen Plasma Surface Modification in Vivo Perspectives References 12 Bioactive Polyaryletherketone Composites Introduction Processing-Structure Relationships PAEK Synthesis and Structure Bioactive Reinforcement Synthesis and Structure Composite Manufacturing and Microstructure Mixing Processes Molding Processes Modification Microstructural Characterization Structure-Property Relationships Biological Properties In Vitro Investigations In Vivo Investigations Functional Properties Mechanical Properties Concluding Remarks References 13 Porosity in PEEK Introduction Porous Biomaterials in Existing Implants Porous Polymer Production for Industrial Applications Manufacturing of Porous PEEK Biomaterials Particulate Leaching Heat Sintering Selective Laser Sintering (SLS) Microwave Sintering Micromachining Textiles Case Study 1. Porosity Through Porogen Leaching at Production Scale Material Manufacture Mechanical Testing In Vitro Testing In Vivo Study Mechanical Testing-Cortical Sites Only Bone Ongrowth Quantification-Cortical and Cancellous Sites Histology Discussion Case Study 2-Comparison of Small and Large Pore Sizes Case Study 3-Mid-Sized Porosity Commercialization of Porous PEEK Biomaterials Manufacture of Surface-Porous PEEK Properties of PEEK Scoria Osseointegration of PEEK Scoria Clinical Experience of Vertera COHERE Cervical Intervertebral Spinal Fusion Device Conclusions References 14 Phospholipid Polymer-Grafted Poly(Ether-Ether-Ketone) by Self-Initiated Surface Grafting Self-Initiated Surface Graft Polymerization Polymer Surface Modification Photoinduced Surface ``Grafting From´´ Polymerization Self-Initiated Surface Graft Polymerization on Poly(Ether-Ether-Ketone) Multifunctional Surface of Phospholipid Polymer-Grafted PEEK High Lubricity High Wear Resistance Antibacterial Adherence Antithrombogenesis Bulk Properties of Phospholipid Polymer-Grafted PEEK Future Perspectives References Part 3: PEEK Applications in Medical Devices 15 Development and Clinical Performance of PEEK Intervertebral Cages Introduction Origins of Interbody Fusion and the ``Cage Rage´´ of the Late 1990s CFR-PEEK Lumbar Cages: The Brantigan Cage Natural PEEK Fusion Cages Clinical Diagnostic Imaging of PEEK Spinal Cages and CFR-PEEK Pedicle Screws Complications Using PAEK Cages Alternatives to Natural PEEK Cages Titanium-Coated PEEK Cages PEEK-HA Cages 3D-Printed, Porous Titanium Cages Porous PEEK Cages Summary References 16 Dynamic Stabilization and Semirigid PEEK Rods for Spinal Fusion Introduction Interspinous Process Spacers Pedicle-Based Posterior Stabilization Early Pedicle-Based Systems: Graf Ligaments and Dynesys PEEK Rods Clinical Studies of PEEK Rods Retrieval Analysis of Explanted PEEK Rods Summary Acknowledgment References 17 Applications of Polyetheretherketone in Arthroscopy Introduction to Arthroscopic Repair Historical Arthroscopic Anchor Materials PEEK Anchors Current Landscape for PEEK Suture Anchors PEEK Interference Screws and Fixators Clinical Studies Summary Acknowledgments References 18 Polyetheretherketone in Trauma Introduction Principles of Fracture Repair Mechanical Stability in Fracture Healing Stress Shielding After Fracture Healing PEEK in Trauma Limitations Preclinical Evaluation of Semirigid Fracture Fixation Plates Clinical Evaluation of PEEK Trauma Implants Ankle Fractures Humeral Fractures Distal Radius Fractures Distal Femur Fractures Summary References Further Reading 19 Applications of Polyetheretherketone in Craniomaxillofacial Surgical Reconstruction Introduction Introduction to Cranioplasty Historical Cranial Implant Materials PEEK Cranial Implants Clinical Studies Current Landscape for PEEK Cranial Defect Implants Conclusion References 20 Applications of PEEK in the Dental Field Introduction Stock Devices Custom Devices Clinical Experience of PEEK Frameworks for Implant-Supported Prosthetics Clinical Implications Materials and Methods Results Discussion Conclusions Summary References 21 Isoelastic PEEK Implants for Total Joint Replacement Introduction Incompatible Design Goals for an Uncemented Hip Stem Setbacks With Early Polymer-Metal Composite Hip Stems The Epoch Hip Stem Other PAEK Composite Hip Stems Stress Shielding in the Acetabulum PEEK in the Acetabulum Outlook for PEEK in Orthopaedic Implants References 22 Biologic Responses to Polyetheretherketone (PEEK) Wear Particles Introduction Isolation and Characterization of Particles Generated In Vitro Biological Responses to PEEK and CFR-PEEK Particles Recent Innovations All Polymer Knee Additive Manufacture of PEEK Materials for Medical Applications Discussion Acknowledgments References 23 Biotribology of PEEK Bearings in Multidirectional Pin-on-Disk Testers Introduction The Role of Multidirectional Pin-on-Disk Testers Basic Biotribology Studies of Hard-on-Soft PEEK Articulations Basic Biotribology Studies of All-Polymer PEEK Articulations Heat Transfer During PEEK Articulations Summary and Concluding Remarks References 24 PEEK Bearing Materials for Total Joint Replacement Introduction Development of CFR-PEEK for Total Hip and Knee Replacement Carbon-UHMWPE Composites in Joint Replacement CFR-PEEK in Joint Replacements PEEK OPTIMA Wear Performance: Medical-Grade CFR-PEEK for Bearing Applications Hip Resurfacing Mobile Bearing, Unicondylar Knee Joint Replacements Rotating-Hinge TKRs PEEK Femoral Components in Primary TKA Other Total Joint Replacement Applications Summary and Concluding Remarks References Further Reading 25 PEEK-on-Ceramic Cervical Disc Arthroplasty Introduction SimplifyTM Disc Design Preclinical Testing Clinical Use Surgical Technique OUS Commercial Experience One-Level IDE Two-Level IDE Conclusion References 26 FDA Regulation of PEEK Implants Introduction What Is the FDA? Common Misconceptions About What the FDA Does Brief History of the FDA Medical Device Definition and Classification Regulatory Approval Process and Types of Applications Content of an FDA Application Material Considerations Function Biocompatibility Current Uses of PEEK in the FDA-Approved Spinal and Orthopedic Implants Intervertebral Body Fusion Devices Vertebral Body Replacements Spinal Fusion Rods The Use of Master Files in Supplying Material Data for the FDA Regulation The Use of Standards in the FDA Regulation Types of Standards The Standards Development Process Benefits and Limitations of Using Standards ASTM Standard Specification for PEEK Summary and Conclusions References Index A B C D E F G H I J K L M N O P Q R S T U V W X Z Back Cover