Fluorinated polymers have exceptional properties such as chemical resistance, neutral surfaces, modest mechanical properties, low coefficient of friction, resistance to flex fatigue and excellent performance at extreme high and low temperatures. Owing to these properties, fluoropolymers have been widely used in biomedical applications. Applications of Fluoropolymers in Medical Devices provides practical and comprehensive information on the structure, characteristics, properties, and processing methods of fluoropolymers commonly used for biomedical applications, along with a thorough description of several different medical devices containing fluoropolymers. The first part of this book describes material biocompatibility and fluoropolymers used in medical devices. Fluoropolymer types, properties and processing of parts, shapes, coatings and PTFE, such as microporous membrane and ePTFE, are discussed. The second part describes important devices containing fluoropolymers, and include a detailed overview of the design, fabrication methods, applications, and competitive materials of these devices. This book is the most authoritative reference to the subject available, and a valuable reference to scientists and engineers working in the medical device and technology areas.
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Technology
Maße
Höhe: 276 mm
Breite: 215 mm
ISBN-13
978-0-443-21921-4 (9780443219214)
Schweitzer Klassifikation
Autor*in
Fluoroconsultants Group, Chadds Ford, PA, USA
Sina Ebnesajjad is the series editor of Plastics Design Library (PDL) published in the William Andrew imprint of Elsevier. This Series is a unique series, comprising technology and applications handbooks, data books and practical guides tailored to the needs of practitioners. Sina was the editor-in-chief of William Andrew Publishing from 2005 to 2007, which was acquired by Elsevier in 2009.
He retired as a Senior Technology Associate in 2005 from the DuPont fluoropolymers after nearly 24 years of service. Sina founded of FluoroConsultants Group, LLC in 2006 where he continues to work. Sina earned his Bachelor of Science from the School of Engineering of the University of Tehran in 1976, Master of Science and PhD from the University of Michigan, Ann Arbor, all in Chemical Engineering.
He is author, editor and co-author of fifteen technical and data books including five handbooks on fluoropolymers technology and applications. He is author and co-author of three books in surface preparation and adhesion of materials, two of which are in their second editions. Sina has been involved with technical writing and publishing since 1974.
His experiences include fluoropolymer technologies (polytetrafluoroethylene and its copolymers) including polymerization, finishing, fabrication, product development, failure analysis, market development and technical service. Sina holds six patents.
Senior Engineering Specialist, B. Braun Medical Inc., USA
Dr. Syed Ali Ashter is the Founder of Ashter Enterprise, LLC, a material evaluation, product development and quality compliance consulting company, which he founded in 2020. He also works as a Senior Engineering Specialist at B. Braun Medical Inc. in Irvine California. He has served on the Board of Directors for the Society of Plastics Engineer's Medical Plastics Division (MPD) since 2012. Recently, he has completed 2-year term as the chair of the Medical Plastics Division. He has authored four Plastics Engineering books in the Plastics Design Library Handbook Series.
Chapter 1 Introduction
1.1 Definition of Medical Devices
1.2 Applications of Medical Devices
1.3 Classification of Medical Devices
1.3.1 Diagnostic
1.3.2 Therapeutic
1.3.3 Implants
1.4 Medical Device Materials
1.5 Applications of Polymers in Medical Devices
Chapter 2 Biocompatibility and Regulatory Compliance
2.1 Material Biocompatibility
2.2 Assessment of Compatibility
2.2.1 Testing Strategies
2.3 Biocompatibility Test Methods
2.4 Biocompatibility of Fluoropolymers
Chapter 3 Fundamental Characteristics and Properties of Fluorinated Polymers
3.1 Uniqueness of Fluorine
3.2 Role C-F Bond in Fluoropolymers
3.3 Fluoropolymer Types: Homopolymers and Copolymers
Chapter 4 Modification of Fluoropolymer Surfaces
4.1 Perfluorinated and Partially Fluorinated Surfaces.
4.2 Methods for Surface modification of Fluoropolymers
4.3 Surface Tuning and Grafting of PTFE by Plasma Treatment
Chapter 5 Assessment of Fluoropolymers for use in Medical Devices
5.1 Introduction
5.2 Polymer characterization
5.3 Sterilization
5.4 Chemical resistance
5.5 Identification of extractable and leachable material
5.6 Biocompatibility
5.7 Shelf life and stability.
Chapter 6 Fluoropolymer Parts for Medical Devices
6.1 Microporous Membranes
6.2 Films and Sheets
6.3 Tubes (e.g. heat shrink)
6.4 Rods
6.5 Densified Films
Chapter 7 Sterilization and Disinfection of Fluoropolymer Parts
7.1 Introduction
7.2 Definitions of Sterilization and Disinfection
7.3 Commercial Sterilization Methods
7.4 Advantages/disadvantages of Sterilization Methods
Chapter 8 Introducers
8.1 Introduction to Access (access, needles, wire, catheter)
8.2 Introducer types
8.3 Micro-introducers
8.4 Peel-away introducer
8.5 Tracheal tube introducers
Chapter 9 Sutures (Sina Ebnesajjad)
9.1 Introduction and Types (PTFE, PTFE Coated)
9.2 Mono and Multi Filament
9.3 Surgical
9.4 Dental
Chapter 10 Lead Assemblies (Patents)
10.1 Introduction
10.2 Types
10.3 Cardiac Devices
Chapter 11 Catheters (Ali Ashter)
11.1 Introduction and Types
11.2 Multilumen Catheters
11.3 Guiding Catheters (active or passive manipulation)
11.4 External Catheters
11.5 MicroCatheters
11.6 Catheter Balloons
Chapter 12 Cardiovascular Devices
12.1 Vascular Implants
12.2 Covered Stents
12.3 Prosthetic Heart Valves
12.4 Vena Cava Filters
Chapter 13 ePTFE Tissue Meshes
Chapter 14 Arteriovenous ePTFE Grafts for Dialysis
14.1 Introduction and Types
14.1.1 Access
14.2 Dialysis
Chapter 15 Ligament Reconstruction and Replacement
Chapter 16 Other Devices
16.1 Coated wire
16.2 Closure Device
16.3 Microfiltration Media
16.4 PTFE Coated Electrodes
16.5 Electrosurgical blades
16.6 Forceps
16.7 Surgical (Suture) Needles
17.7.1 Tapered Needles
17.7.2 Cutting Suturing Needles
16.8 Hypodermic Needles
16.9 Mini-Vacutron
Chapter 17 Radiopacity
17.1 Introduction
17.2 Fluoroscopy and X-ray Imaging
17.3 Additives to impart Radiopacity
17.4 Applications of Radiopaque Devices
Appendix I Classification and Regulation of Medical Devices
A-1.1 FDA
A-1.2 ISO
