PEEK Biomaterials Handbook (Plastics Design Library)

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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
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