Biotextiles as Medical Implants Edited by Martin W. King, Bhupender S. Gupta and Robert Guidoin

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Biotextiles as Medical Implants
Edited by Martin W. King, Bhupender S. Gupta and Robert Guidoin

Biotextiles as medical implants

Contents

Contributor contact details xv
Woodhead Publishing Series in Textiles xxi
Preface xxvii
Introduction xxxi

Part I Technologies 1
1 Manufacture, types and properties of biotextiles
for medical applications 3
B. S. Gupta, North Carolina State University, USA
1.1 Introduction 3
1.2 Fiber structure 4
1.3 Formation of synthetic fibers 5
1.4 Processing of short (staple) and continuous (filament) fibers 10
1.5 Understanding structure in fibers 15
1.6 Fibrous materials used in medicine 18
1.7 Key fiber properties 25
1.8 Textile assemblies and their characteristics 34
1.9 Conclusion 44
1.10 Sources of further information and advice 44
1.11 Acknowledgments 45
1.12 References 45
2 Nanofiber structures for medical biotextiles 48
B. S. Gupta, North Carolina State University, USA and
A. K. Moghe, Covidien, USA
2.1 Introduction 48
2.2 Techniques for producing nanofi bers 50
2.3 The electrospinning process 53
2.4 Using electrospun poly( ε -caprolactone) (PCL) fi bers as scaffolds for tissue engineering 57
2.5 Co-axial bicomponent nanofi bers and their production 64
2.6 Case study: collagen/PCL bicomponent nanofi ber scaffolds for engineering bone tissues 71
2.7 In vivo case study: engineering of blood vessels 73
2.8 Miscellaneous applications of co-axial nanofi ber structures 77
2.9 Conclusion 85
2.10 References 85
3 Resorbable polymers for medical applications 91
S. H. Kim, Biomaterials Research Center, KIST and Korea
University, South Korea and Y. Jung, Biomaterials Research
Center, KIST, South Korea
3.1 Introduction 91
3.2 Polymer degradation 93
3.3 Mechanical properties of existing resorbable polymers 94
3.4 Mechano-active tissue engineering 96
3.5 Elastomeric properties of fi ber-forming copolymers 97
3.6 Elastomeric resorbable polymers for vascular tissue engineering 101
3.7 Conclusion and future trends 108
3.8 Sources of further information and advice 109
3.9 References 110
4 Shaped biotextiles for medical implants 113
B. S. Gupta, North Carolina State University, USA
4.1 Introduction 113
4.2 Vascular grafts: key developments 114
4.3 Weaving, knitting and ePTFE technologies for producing tubular structures 116
4.4 Improving surface properties: velour construction 119
4.5 Multilimbed grafts 121
4.6 Heat setting for a more resilient crimped circular configuration 124
4.7 Grafts with taper and varying diameter 126
4.8 Tubular structures for other devices: ligaments, hernia and prolapsed repair meshes 127
4.9 Three-dimensional textile structures 128
4.10 Performance requirements of implants in the body 131
4.11 Conclusion 135
4.12 Acknowledgements 135
4.13 References 135
5 Surface modifi cation of biotextiles for medical applications 137
D. Tessier, CTT Group, Canada
5.1 Introduction 137
5.2 Nano-coatings 138
5.3 Preparation of textile surfaces 139
5.4 Plasma technologies for surface treatment 141
5.5 Measuring surface properties of textiles: SEM and XPS 142
5.6 Testing antimicrobial coatings 145
5.7 Applications of surface treatments in medical textiles 146
5.8 Future trends 149
5.9 Sources of further information and advice 150
5.10 References 151
6 Sterilization techniques for biotextiles for medical applications 157
S. W. Shalaby, S. D. Nagatomi and E. F. Powell,
Poly-Med, Inc., USA
6.1 Introduction 157
6.2 Bioburden and principles of sterilization 158
6.3 Traditional sterilization: advantages and disadvantages 158
6.4 Emerging and less traditional sterilization methods 160
6.5 Radiochemical sterilization (RCS) 162
6.6 Application of RCS technology 164
6.7 Conclusion and future trends 167
6.8 Sources of further information and advice 167
6.9 References 168
7 Regulation of biotextiles for medical use 169
E. Duncan, Paladin Medical, Inc., USA
7.1 Introduction 169
7.2 US regulation of biotextiles 169
7.3 European Union regulation of biotextiles 172
7.4 Quality standards for biotextiles 172
7.5 The role of quality standards in the development of biotextiles 174
7.6 Safety issues with ‘me-too’ products with new intended uses 177
7.7 Dealing with cutting-edge technology 178
7.8 Conclusion 180
7.9 References 180
8 Retrieval studies for medical biotextiles 182
C. R. Gajjar and M.W. King, North Carolina State
University, USA and R. Guidoin, Laval University, Canada
8.1 Introduction 182
8.2 Standards and animal models for implant retrieval studies 185
8.3 Testing retrieved biotextile implants: harvesting, test planning, sample preparation and cleaning 187
8.4 Testing retrieved biotextile implants: analytical techniques 189
8.5 Specialized tests for specifi c retrieval studies 203
8.6 Precautions for retrieval studies 204
8.7 Limitations of retrieval studies 205
8.8 Conclusion and future trends 206
8.9 References 207

Part II Applications 211
9 Drug delivery systems using biotextiles 213
L.-M. Zhu and D. G. Yu, Donghua University, People’s
Republic of China
9.1 Introduction 213
9.2 Types of drugs 216
9.3 Types of polymers 217
9.4 Technologies and fi ber structures 220
9.5 Types of drug delivery systems (DDS) 222
9.6 Future trends 227
9.7 Acknowledgements 227
9.8 References 228
10 Types and properties of surgical sutures 232
C. C. Chu, Cornell University, USA
10.1 Introduction 232
10.2 Classifi cation of suture materials 233
10.3 Essential properties of suture materials 238
10.4 Dyes and coatings to improve suture identifi cation and properties 258
10.5 References 259
10.6 Appendix: further information on sutures 264
11 Materials for absorbable and nonabsorbable surgical sutures 275
C. C. Chu, Cornell University, USA
11.1 Introduction 275
11.2 Natural materials for absorbable sutures 276
11.3 Synthetic materials for absorbable sutures 277
11.4 Materials for nonabsorbable sutures 292
11.5 Future trends 304
11.6 Sources of further information and advice 316
11.7 References 317
11.8 Appendix: further information on sutures 324
12 Surgical knot performance in sutures 335
B. S. Gupta, North Carolina State University, USA
12.1 Introduction 335
12.2 Tensile properties of knotted sutures 337
12.3 Knot strength 341
12.4 Performance in dynamic tests 343
12.5 Knot security 346
12.6 Friction in sutures and friction-based hypothesis of knot security 349
12.7 The use of lasers to improve knot security 353
12.8 The use of tissue adhesive to improve knot security 360
12.9 Conclusion 362
12.10 Acknowlegements 363
12.11 References 363
13 Barbed suture technology 366
N. P. Ingle, University of Minnesota and North Carolina
State University, USA and H. Cong and M. W. King,
North Carolina State University, USA
13.1 Introduction 366
13.2 The development of barbed sutures 368
13.3 Materials for barbed sutures 372
13.4 Barbed suture design and manufacture 374
13.5 Testing and characterization 379
13.6 Properties of barbed sutures 381
13.7 Surgical techniques using barbed sutures 389
13.8 Applications of barbed sutures 391
13.9 Sources of further information and advice 399
13.10 Acknowledgement 401
13.11 References 401
14 Small-diameter arterial grafts using biotextiles 408
B. S. Gupta, North Carolina State University, USA
14.1 Introduction 408
14.2 Understanding compliance 409
14.3 Tests for compliance 411
14.4 Testing compliance in practice: a case study 419
14.5 Engineering small-diameter vascular grafts by weaving 421
14.6 Using elastomeric threads to construct small-diameter vascular grafts 426
14.7 Summary 429
14.8 Acknowledgements 431
14.9 References 431
15 Vascular prostheses for open surgery 434
R. Guidoin, Laval University, Canada, M. W. King, North
Carolina State University, USA, L. Wang, Donghua
University, People’s Republic of China, Z. Zhang,
Laval University, Canada, R. Guzman, University of
Manitoba, Canada, G. Marinov, Medical University
of Varna, Bulgaria and Y. Douville, Laval University, Canada
15.1 Introduction 434
15.2 Arterial pathologies 435
15.3 The development of modern vascular surgery 437
15.4 Vascular grafts of biological origin 438
15.5 Vascular prostheses from synthetic polymers and biopolymers 441
15.6 Improving current vascular prostheses 462
15.7 Conclusion 470
15.8 References 470
16 Biotextiles as percutaneous heart valves 485
F. Heim and B. Durand, Universite de Haute-Alsace,
France and N. ChakfE, H ô pitaux Universitaires de
Strasbourg, France
16.1 Introduction 485
16.2 Heart valve replacement: critical issues 486
16.3 Textile valves: manufacturing requirements 491
16.4 Textile valves: in vitro performance 499
16.5 Textile valves: long-term performance 506
16.6 Textile valves: in vivo performance 522
16.7 Conclusions and future trends 523
16.8 References 524
17 Biotextiles as vena cava fi lters 526
H.-I. Yoon, Athlone Institute of Technology, Ireland and
North Carolina State University, USA and H. Cong and
M. W. King, North Carolina State University, USA
17.1 Introduction 526
17.2 Current fi lters for embolic protection in the IVC 528
17.3 An ‘ideal’ IVC fi lter design 533
17.4 References 534
18 Biotextiles for atrial septal defect repair 536
L. A. Eadie, New Balance Athletic Shoes Inc. and North
Carolina State University, USA and M. W. King,
North Carolina State University, USA
18.1 Introduction 536
18.2 Anatomy and physiology of a normal functioning heart 537
18.3 Epidemiology, pathology, incidence and patient population of ASDs 538
18.4 Historical methods of ASD repair 542
18.5 Current noninvasive treatments, therapies and devices used to repair ASDs 543
18.6 Advantages and disadvantages of the current technology 553
18.7 Future trends 557
18.8 Conclusion 557
18.9 Sources of further information and advice 558
18.10 References 558
19 Hemostatic wound dressings 563
C. R. Gajjar, M. G. McCord and M. W. King, North
Carolina State University, USA
19.1 Introduction 563
19.2 The importance of hemostatic textiles 564
19.3 Understanding the clotting of blood 565
19.4 Infl uence of foreign surfaces on blood clotting 571
19.5 Existing hemostatic materials 577
19.6 Future trends 583
19.7 References 585
20 Anterior cruciate ligament prostheses using biotextiles 590
M. Laflamme, J. Lamontagne and R. Guidoin, Laval University, Canada
20.1 Introduction 590
20.2 Anatomy and structure of the anterior cruciate ligament (ACL) 591
20.3 Biomechanics of the ACL 595
20.4 Clinical problems associated with the ACL 596
20.5 Diagnosis and treatment of ACL ruptures 598
20.6 Autograft for ACL reconstruction 600
20.7 Allograft for ACL reconstruction 608
20.8 Graft healing in ACL reconstructive surgery 609
20.9 The use of synthetic materials and prostheses in ACL reconstructive surgery 612
20.10 Complications with synthetic ligaments 618
20.11 Augmentation devices 622
20.12 Tissue engineering and scaffolds 623
20.13 Xenografts 628
20.14 Conclusion 629
20.15 References 629
21 Endovascular prostheses for aortic aneurysms: a new era for vascular surgery 640
G. Marinov, Medical University of Varna, Bulgaria,
R. Guidoin, Laval University, Canada, L. W. Tse,
Toronto General Hospital, Canada, L. Wang, Donghua University,
People’s Republic of China, A. A. Ruthrauff, Secant
Medical Inc. and North Carolina State University, USA
and T. Yao and M. W. King, North Carolina State University, USA
21.1 Introduction 640
21.2 History and advantages of stent grafts 644
21.3 Stent graft design and performance 647
21.4 Prefenestrated devices for juxtarenal aneurysms 664
21.5 Novel approaches to the treatment of juxtarenal and suprarenal aneurysms 670
21.6 Conclusion 671
21.7 References 672
Index 677

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