Durability and reliability of medical polymers

289 Pages·2012·6.839 MB·English

by  Mike Jenkins, Artemis Stamboulis

Durability and reliability of medical polymers
© Woodhead Publishing Limited, 2012
Related titles:
Biocompatibility and performance of medical devices
(ISBN 978-0-85709-070-6)
Implant and device manufacturers are increasingly being faced with the challenge of
proving that their implants or devices are safe/biocompatible and perform as expected.
This book describes and explains the factors that influence the biocompatibility of
materials and medical devices, the methods to predict or screen biocompatibility,
how to build a biological safety evaluation plan for medical devices, strategies and
tactics in biocompatibility and biological performance evaluation of medical devices.
It also provides insights into recent changes in regulations and standards, standards
interpretation and worldwide health authorities’ expectations with regard to the
biocompatibility and performance of new products.
Biomaterials in plastic surgery: Breast implants
(ISBN 978-1-84569-799-0)
Breast implants are one of the most regularly used prostheses (both for cosmetic and
reconstructive purposes) in plastic surgery. Unfortunately, they are also one of the
most controversial implants available and some types of breast implants have gained
a reputation for being unreliable and in some cases dangerous. This book discusses
the history of this lucrative field and how it is developing. Chapters in Part I explore a
wide range of breast implants whilst chapters in Part II review important safety issues.
Joining and assembly of medical materials and devices
(ISBN 978-1-84569-577-4)
Medical devices are becoming more intricate with the use of a wide range of materials
and components that must be joined effectively and safely. Joining and assembly of
medical materials and devices provides a comprehensive analysis of the practical
techniques that can be used to join and assemble medical materials. Part I reviews
issues such as adhesive selection, testing and modelling. Part II discusses processes,
materials and applications whilst the final set of chapters reviews safety and regulatory
considerations.
Details of these and other Woodhead Publishing books can be obtained by:
∑ visiting our website at www.woodheadpublishing.com
∑ contacting Customer Services (e-mail: [email protected]; fax:
[phone]; tel.: [phone] ext. 130; address: Woodhead
Publishing Limited, 80 High Street, Sawston, Cambridge CB22 3HJ, UK)
∑ contacting our US office (e-mail: [email protected]; tel.
[phone]; address: Woodhead Publishing, 1518 Walnut Street, Suite 1100,
Philadelphia, PA 19102-3406, USA)
If you would like e-versions of our content, please visit our online platform:
www.woodheadpublishingonline.com. Please recommend it to your librarian so that
everyone in your institution can benefit from the wealth of content on the site.
© Woodhead Publishing Limited, 2012
Woodhead Publishing Series in Biomaterials: Number 44
Durability and
reliability of
medical polymers
Edited by
Mike Jenkins and Artemis Stamboulis
Oxford Cambridge Philadelphia New Delhi
© Woodhead Publishing Limited, 2012
Published by Woodhead Publishing Limited,
80 High Street, Sawston, Cambridge CB22 3HJ, UK
www.woodheadpublishing.com
www.woodheadpublishingonline.com
Woodhead Publishing, 1518 Walnut Street, Suite 1100, Philadelphia, PA 19102-3406, USA
Woodhead Publishing India Private Limited, G-2, Vardaan House, 7/28 Ansari Road,
Daryaganj, New Delhi – 110002, India
www.woodheadpublishingindia.com
First published 2012, Woodhead Publishing Limited
© Woodhead Publishing Limited, 2012
The authors have asserted their moral rights.
This book contains information obtained from authentic and highly regarded sources.
Reprinted material is quoted with permission, and sources are indicated. Reasonable efforts
have been made to publish reliable data and information, but the authors and the publishers
cannot assume responsibility for the validity of all materials. Neither the authors nor the
publishers, nor anyone else associated with this publication, shall be liable for any loss,
damage or liability directly or indirectly caused or alleged to be caused by this book.
Neither this book nor any part may be reproduced or transmitted in any form or by any
means, electronic or mechanical, including photocopying, microfilming and recording, or by
any information storage or retrieval system, without permission in writing from Woodhead
Publishing Limited.
The consent of Woodhead Publishing Limited does not extend to copying for general
distribution, for promotion, for creating new works, or for resale. Specific permission must
be obtained in writing from Woodhead Publishing Limited for such copying.
Trademark notice: Product or corporate names may be trademarks or registered trademarks,
and are used only for identification and explanation, without intent to infringe.
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library.
Library of Congress Control Number: 2012939821
ISBN 978-1-84569-929-1 (print)
ISBN 978-0-85709-651-7 (online)
ISSN 2049-9485 Woodhead Publishing Series in Biomaterials (print)
ISSN 2049-9493 Woodhead Publishing Series in Biomaterials (online)
The publisher’s policy is to use permanent paper from mills that operate a sustainable
forestry policy, and which has been manufactured from pulp which is processed using
acid-free and elemental chlorine-free practices. Furthermore, the publisher ensures that
the text paper and cover board used have met acceptable environmental accreditation
standards.
Typeset by Replika Press Pvt Ltd, India
Printed by TJ International Ltd, Padstow, Cornwall, UK
© Woodhead Publishing Limited, 2012
Contents
Contributor contact details ix
Woodhead Publishing Series in Biomaterials xi
Part I Types and properties of bioresorbable medical
polymers 1
1 Types of bioresorbable polymers for medical
applications 3
T. Casalini and G. Perale, Politecnico di Milano, Italy
1.1 Introduction 3
1.2 Aliphatic polyesters 5
1.3 Polyanhydrides 10
1.4 Poly(ortho esters) 12
1.5 Polyphosphazenes 16
1.6 Poly(amino acids) and ‘pseudo’ poly(amino acids) 19
1.7 Polyalkylcyanoacrylates 23
1.8 Poly(propylene fumarate) (PPF), poloxamers,
poly(p-dioxanone) (PPDO), polyvinyl alcohol (PVA) 24
1.9 References 26
2 The effect of molecular structure on the properties
of biomedical polymers 30
G. PerTiCi, Industrie Biomediche Insubri SA, Switzerland
2.1 Introduction: the molecular structure of polymers 30
2.2 Molecular weight and polymer properties 33
2.3 Macromolecular conformation, crystallisation and
polymer properties 35
2.4 The effect of the amorphous state and glass transition
temperature on polymer properties 40
2.5 Biphasic systems: linear crystalline polymers and their
properties 45
2.6 References 47
© Woodhead Publishing Limited, 2012
vi Contents
3 Processing of bioresorbable and other polymers for
medical applications 49
T. Casalini and G. Perale, Politecnico di Milano, Italy
3.1 Introduction 49
3.2 Extrusion 50
3.3 Mixing processes 52
3.4 Molding processes 55
3.5 Secondary shaping 61
3.6 Calendering 65
3.7 Coating 67
3.8 Foaming 68
3.9 Solvent casting 69
3.10 Challenges in biopolymer processing 69
3.11 Conclusions 74
3.12 References 75
4 Understanding transport phenomena and
degradation of bioresorbable medical polymers 77
F. rossi and G. Perale, Politecnico di Milano, Italy
4.1 Introduction to transport phenomena in irreversible
processes 77
4.2 Introduction to mathematical modelling 89
4.3 Conclusions and future trends 94
4.4 References 95
5 Synthetic bioresorbable polymers 96
r. e. Cameron and a. Kamvari-moGhaddam, University of
Cambridge, UK
5.1 Introduction 96
5.2 Bioresorbable polymers 97
5.3 Degradation of aliphatic polyesters 101
5.4 Factors affecting aliphatic polymer degradation 107
5.5 Processing and devices 112
5.6 Conclusions 113
5.7 Sources of further information and advice 114
5.8 References 114
6 Using synthetic bioresorbable polymers for
orthopedic tissue regeneration 119
m. sanToro, Politecnico di Milano, Italy and G. Perale, Industrie
Biomediche Insubri SA, Switzerland
6.1 Introduction 119
6.2 Poly(a-hydroxy acids) 121
© Woodhead Publishing Limited, 2012
Contents vii
6.3 Polylactones 126
6.4 Polyanhydrides 129
6.5 Fumarate-based polymers 131
6.6 Hydrogels 133
6.7 Future trends 133
6.8 Conclusions 135
6.9 References 136
Part II Aspects of durability and reliability of
non-bioresorbable medical polymers 141
7 Wear processes in polymer implants 143
d. e. T. shePherd and K. d. dearn, University of Birmingham,
UK
7.1 Introduction 143
7.2 Implants 143
7.3 Wear processes and theory for polymer implants 147
7.4 Polymers 151
7.5 Wear debris in the body 156
7.6 Future trends 158
7.7 Sources of further information and advice 158
7.8 References 159
8 Ageing processes of biomedical polymers in the
body 164
a. mahomed, University of Birmingham, UK
8.1 Introduction 164
8.2 Principles of chemical and biochemical degradation and
calcification 165
8.3 Effect of natural ageing of medical polymers 168
8.4 Principles of accelerated ageing 171
8.5 Conclusions and summary 175
8.6 Sources of further information and advice 176
8.7 Acknowledgements 176
8.8 References 176
9 The failure of synthetic polymeric medical devices 183
P.r. lewis, The Open University, UK
9.1 Introduction 183
9.2 Forensic methods 185
9.3 Catheter failure 189
9.4 Balloon catheters and angioplasty 201
© Woodhead Publishing Limited, 2012
viii Contents
9.5 Breast implants 203
9.6 Intraocular lenses 210
9.7 Failure of Foley catheters 213
9.8 Sutures 218
9.9 Conclusions 222
9.10 Acknowledgements 223
9.11 References 223
10 Manufacturing defects in polymeric medical devices 225
P. R. lewis, The Open University, UK
10.1 Introduction 225
10.2 Polymer moulding 226
10.3 Catheter systems 232
10.4 Security cap for gas cylinders 242
10.5 Breathing tube failures 247
10.6 A failed crutch 254
10.7 Cracked medical tubing 259
10.8 Conclusions 266
10.9 Acknowledgements 267
10.10 References 267
Index 269
© Woodhead Publishing Limited, 2012
Contributor contact details
(* = main contact)
Editors Chapter 2
Mike Jenkins* and Artemis Dr Gianni Pertici
Stamboulis Industrie Biomediche Insubri SA
School of Metallurgy and Materials via Cantonale CH-6805
University of Birmingham Mezzovico
Edgbaston Switzerland
Birmingham
UK E-mail: [email protected]
B15 2TT
Chapter 4
E-mail: [email protected];
[email protected] Filippo Rossi* and Giuseppe Perale
Politecnico di Milano
Department of Chemistry, Materials
Chapters 1 and 3
and Chemical Engineering
Tommaso Casalini and Giuseppe ‘Giulio Natta’
Perale* Via Mancinelli 7, 20131 Milan
Politecnico di Milano Italy
Department of Chemistry, Materials
and Chemical Engineering E-mail: [email protected];
‘Giulio Natta’ [email protected]
Via Mancinelli 7, 20131 Milan
Italy
E-mail: [email protected].
it; [email protected]
© Woodhead Publishing Limited, 2012