Kurtz PEEK Biomaterials Handbook

1. Auflage 2011
ISBN: 978-1-4377-4464-4
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 306 Seiten

Reihe: Plastics Design Library

PEEK biomaterials are currently used in 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 hip replacements to finger joints and dental implants. This 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. Steven Kurtz, author of the well respected UHMWPE Biomaterials Handbook and Director of the Implant Research Center at Drexel University, has developed a one-stop reference covering the processing and blending of PEEK, its properties and biotribology, and the expanding range of medical implants using PEEK: spinal implants, hip and knee replacement, etc. - Covering materials science, tribology and applications - Provides a complete reference for specialists in the field of plastics, biomaterials, biomedical engineering and medical device design and surgical applications

Autoren/Hrsg.

Kurtz, Steven M.

Inhaltsverzeichnis

1;Front Cover;1
2;Dedication;3
3;Series page;3
4;Peek Biomaterials Handbook;4
5;Copyright;5
6;Contents;6
7;Foreword;8
8;List of Contributors;10
9;Chapter 1 - An Overview of PEEK Biomaterials;12
9.1;1.1 - Introduction;12
9.2;1.2 - What Is a Polymer?;13
9.3;1.3 - What Is PEEK?;13
9.4;1.4 - Crystallinity and PEEK;14
9.5;1.5 - Thermal Transitions;14
9.6;1.6 - PEEK Composites;15
9.7;1.7 - Overview of This Handbook;16
9.8;References;17
10;Chapter 2 - Synthesis and Processing of PEEK for Surgical Implants;20
10.1;2.1 - Introduction;20
10.2;2.2 - Synthesis of PAEKs;20
10.3;2.3 - Nomenclature;23
10.4;2.4 - Quality Systems for Medical Grade Resin Production;25
10.5;2.5 - Processing of Medical Grade PEEK;26
10.6;2.6 - Machining;32
10.7;2.7 - Summary;32
10.8;Acknowledgments;33
10.9;References;33
11;Chapter 3 - Compounds and Composite Materials;34
11.1;3.1 - Introduction;34
11.2;3.2 - What Is a Composite Material?;36
11.3;3.3 - Additive Geometry, Volume, and Orientation Effects;43
11.4;3.4 - Preparation of Materials;47
11.5;3.5 - Processing to Make Parts;49
11.6;3.6 - Biocompatibility of CFR PEEK;56
11.7;3.7 - Summary and Conclusions;57
11.8;References;57
12;Chapter 4 - Morphology and Crystalline Architecture of Polyaryletherketones;60
12.1;4.1 - Introduction;60
12.2;4.2 - Chain Architecture and Packing;60
12.3;4.3 - Crystallization Behavior;63
12.4;4.4 - Characterization Techniques;63
12.5;4.5 - Structure Processing–Property Relationships;68
12.6;4.6 - Summary and Conclusions;69
12.7;Acknowledgment;70
12.8;References;70
13;Chapter 5 - Fracture, Fatigue, and Notch Behavior of PEEK;72
13.1;5.1 - Introduction;72
13.2;5.2 - Fracture and Fatigue of Materials;72
13.3;5.3 - PEEK Fracture Studies;75
13.4;5.4 - PEEK Notch Studies;76
13.5;5.5 - Summary;79
13.6;Acknowledgments;82
13.7;References;82
14;Chapter 6 - Chemical and Radiation Stability of PEEK;86
14.1;6.1 - Introduction to Chemical Stability;86
14.2;6.2 - Water Solubility;86
14.3;6.3 - Thermal Stability;87
14.4;6.4 - Steam Sterilization of PEEK;87
14.5;6.5 - Radiation Stability: Implications for Gamma Sterilization and Postirradiation Aging;87
14.6;6.6 - Summary;89
14.7;References;89
15;Chapter 7 - Biocompatibility of Polyaryletheretherketone Polymers;92
15.1;7.1 - Introduction;92
15.2;7.2 - Cell Culture and Toxicity Studies;93
15.3;7.3 - Mutagenesis (Genotoxicity);95
15.4;7.4 - Immunogenesis;95
15.5;7.5 - Soft Tissue Response;95
15.6;7.6 - Osteocompatibility of PEEK Devices;95
15.7;7.7 - Biocompatibility of PEEK Particulate—X-STOP™ PEEK Explant Studies;98
15.8;7.8 - Summary and Conclusions;102
15.9;References;102
16;Chapter 8 - Bacterial Interactions with Polyaryletheretherketone;104
16.1;8.1 - Introduction;104
16.2;8.2 - Bacterial Adhesion to Biomaterials;106
16.3;8.3 - The Role of Surface Topography and Chemistry in Bacterial Adhesion;109
16.4;8.4 - Strategies to Reduce Bacterial Adhesion to PEEK;114
16.5;8.5 - Summary and Perspectives;119
16.6;References;120
17;Chapter 9 - Thermal Plasma Spray Deposition of Titanium and Hydroxyapatite on Polyaryletheretherketone Implants;130
17.1;9.1 - Introduction;130
17.2;9.2 - Coating Technology;131
17.3;9.3 - Biomedical Plasma-Sprayed Coatings;133
17.4;9.4 - Coating Analysis Methods;135
17.5;9.5 - Substrate Analysis Method;138
17.6;9.6 - Plasma-Sprayed Coatings on PEEK-Based Substrates;140
17.7;9.7 - Plasma-Sprayed Osteointegrative Surfaces for PEEK: The Eurocoating Experience;142
17.8;9.8 - Summary and Conclusions;150
17.9;References;150
18;Chapter 10 - Surface Modification Techniques of Polyetheretherketone, Including Plasma Surface Treatment;156
18.1;10.1 - PEEK–Tissue Interactions;156
18.2;10.2 - Surface Modification;157
18.3;10.3 - Surface Modification Techniques;159
18.4;10.4 - Applications of These Surface Modification Methods and the Translation to Industry;162
18.5;10.5 - Perspectives;167
18.6;References;167
19;Chapter 11 - Bioactive Polyaryletherketone Composites;174
19.1;11.1 - Introduction;174
19.2;11.2 - Processing–Structure Relationships;175
19.3;11.3 - Structure–Property Relationships;181
19.4;11.4 - Concluding Remarks;185
19.5;References;185
20;Chapter 12 - Porosity in Polyaryletheretherketone;192
20.1;12.1 - Introduction;192
20.2;12.2 - Porous Biomaterials in Existing Implants;193
20.3;12.3 - Porous Polymer Production for Industrial Applications;194
20.4;12.4 - Manufacturing of Porous PEEK Biomaterials;195
20.5;12.5 - Case Study 1—Porosity Through Porogen Leaching at Production Scale;198
20.6;12.6 - Case Study 2—Comparison of Small and Large Pore Sizes;203
20.7;12.7 - Case Study 3—Mid-Sized Porosity;205
20.8;12.8 - Conclusions;207
20.9;Acknowledgment;208
20.10;References;208
21;Chapter 13 - Applications of Polyaryletheretherketone in Spinal Implants: Fusion and Motion Preservation;212
21.1;13.1 - Introduction;212
21.2;13.2 - Origins of Interbody Fusion and the “Cage Rage” of the Late 1990s;213
21.3;13.3 - CFR-PEEK Lumbar Cages: The Brantigan Cage;214
21.4;13.4 - Threaded PEEK Lumbar Fusion Cages;218
21.5;13.5 - Clinical Diagnostic Imaging of PEEK Spinal Cages and Transpedicular Screws;219
21.6;13.6 - Subsidence and Wear of PAEK Cages;220
21.7;13.7 - Posterior Dynamic Stabilization Devices;221
21.8;13.8 - Cervical and Lumbar Artificial Discs;225
21.9;13.9 - Summary;226
21.10;Acknowledgments;227
21.11;References;227
22;Chapter 14 - Isoelastic Polyaryletheretherketone Implants for Total Joint Replacement;232
22.1;14.1 - Introduction;232
22.2;14.2 - Incompatible Design Goals for an Uncemented Hip Stem;233
22.3;14.3 - Setbacks with Early Polymer–Metal Composite Hip Stems;234
22.4;14.4 - The Epoch Hip Stem;235
22.5;14.5 - Other PAEK Composite Hip Stems;240
22.6;14.6 - Stress Shielding in the Acetabulum;241
22.7;14.7 - PEEK in the Acetabulum;243
22.8;14.8 - Outlook for PEEK in Orthopedic Implants;246
22.9;Acknowledgments;248
22.10;References;248
23;Chapter 15 - Applications of Polyetheretherketone in Trauma, Arthroscopy, and Cranial Defect Repair;254
23.1;15.1 - Introduction;254
23.2;15.2 - Principles of Fracture Repair;254
23.3;15.3 - Principles of Arthroscopic Repair;260
23.4;15.4 - Principles of Craniofacial Defect Repair;262
23.5;15.5 - Summary;268
23.6;Acknowledgments;269
23.7;References;269
24;Chapter 16 - Arthroplasty Bearing Surfaces;272
24.1;16.1 - Introduction;272
24.2;16.2 - Total Hip and Knee Replacement;272
24.3;16.3 - Basic Biotribology Studies of PEEK Articulations;277
24.4;16.4 - Hip Resurfacing;280
24.5;16.5 - Mobile-Bearing, Unicondylar Knee Joint Replacements;282
24.6;16.6 - Other Total Joint Replacement Applications;282
24.7;16.7 - MOTIS: Medical Grade CFR-PEEK for Bearing Applications;283
24.8;16.8 - Summary and Concluding Remarks;283
24.9;Acknowledgments;283
24.10;References;283
25;Chapter 17 - FDA Regulation of Polyaryletheretherketone Implants*;288
25.1;17.1 - Introduction;288
25.2;17.2 - What Is the FDA?;288
25.3;17.3 - Common Misconceptions About What the FDA Does;289
25.4;17.4 - Brief History of the FDA;290
25.5;17.5 - Medical Device Definition and Classification;292
25.6;17.6 - Regulatory Approval Process and Types of Applications;293
25.7;17.7 - Content of an FDA Application;295
25.8;17.8 - Material Considerations;297
25.9;17.9 - Current Uses of PEEK in FDA-Approved Spinal and Orthopedic Implants;298
25.10;17.10 - The Use of Master Files in Supplying Material Data for FDA Regulation;299
25.11;17.11 - The Use of Standards in FDA Regulation;300
25.12;17.12 - Summary and Conclusions;302
25.13;References;303
26;Index;304