implants Biotextiles as medical Bhupender S. Gupta and Robert Guidoin TheTextile Institute Edited by Martin W. King,

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1 Woodhead Publishing Series in Textiles: Number 113 Biotextiles as medical implants Edited by Martin W. King, Bhupender S. Gupta and Robert Guidoin TheTextile Institute WP WOODHEAD PUBLISHING Oxford Cambridge Philadelphia New Delhi

2 Contents Contributor contact details xv Wood/lead Publishing Series in Textiles xxi Preface Introduction xxvii 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 Fiber structure Formation of synthetic fibers Processing of short (staple) and continuous (filament) fibers Understanding structure in fibers Fibrous materials used in medicine Key fiber properties Textile assemblies and their characteristics Conclusion Sources of further information and advice Acknowledgments References 45 2 Nanofiber structures for medical biotextiles 48 B. S. Gupta, North Carolina State University, USA and A. K. Mogiie, Covidien, USA 2.1 Introduction Techniques for producing nanofibers The electrospinning process 53 v

3 vi Contents 2.4 Using electrospun poly(e-caprolactone) (PCL) fibers as scaffolds for tissue engineering Co-axial bicomponent nanofibers and their production Case study: collagen/pcl bicomponent nanofiber scaffolds for engineering bone tissues In vivo case study: engineering of blood vessels Miscellaneous applications of co-axial nanofiber structures Conclusion 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 Polymer degradation Mechanical properties of existing resorbable polymers Mechano-active tissue engineering Elastomeric properties of fiber-forming copolymers Elastomeric resorbable polymers for vascular tissue engineering Conclusion and future trends Sources of further information and advice References Shaped biotextiles for medical implants 113 B. S. Gupta, North Carolina State University, USA 4.1 Introduction Vascular grafts: key developments Weaving, knitting and eptfe technologies for producing tubular structures Improving surface properties: velour construction Multilimbed grafts Heat setting for a more resilient crimped circular configuration Grafts with taper and varying diameter Tubular structures for other devices: ligaments, hernia and prolapsed repair meshes Three-dimensional textile structures 128 Woodhead Publishing Limited, 2013

4 Contents vii 4.10 Performance requirements of implants in the body Conclusion Acknowledgements References Surface modification of biotextiles for medical applications 137 D. Tessier, CTT Group, Canada 5.1 Introduction Nano-coatings Preparation of textile surfaces Plasma technologies for surface treatment Measuring surface properties of textiles: SEM and XPS Testing antimicrobial coatings Applications of surface treatments in medical textiles Future trends Sources of further information and advice References 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 Bioburden and principles of sterilization Traditional sterilization: advantages and disadvantages Emerging and less traditional sterilization methods Radiochemical sterilization (RCS) Application of RCS technology Conclusion and future trends Sources of further information and advice References Regulation of biotextiles for medical use 169 E. Duncan, Paladin Medical, Inc., USA 7.1 Introduction US regulation of biotextiles European Union regulation of biotextiles Quality standards for biotextiles 172

5 viii Contents 7.5 The role of quality standards in the development of biotextiles Safety issues with 'me-too' products with new intended uses Dealing with cutting-edge technology Conclusion References Retrieval studies for medical biotextiles 182 C. R. Gajjar and M.W. Kino, North Carolina State University, USA and R. Guidoin, Laval University, Canada 8.1 Introduction Standards and animal models for implant retrieval studies Testing retrieved biotextile implants: harvesting, test planning, sample preparation and cleaning Testing retrieved biotextile implants: analytical techniques Specialized tests for specific retrieval studies Precautions for retrieval studies Limitations of retrieval studies Conclusion and future trends References 207 Part II Applications Drug delivery systems using biotextiles 213 L.-M. Zhu and D. G. Yu, Donghua University, People's Republic of China 9.1 Introduction Types of drugs Types of polymers Technologies and fiber structures Types of drug delivery systems (DDS) Future trends Acknowledgements References Types and properties of surgical sutures 232 C. C. Chu, Cornell University, USA 10.1 Introduction Classification of suture materials 233

6 Contents ix 10.3 Essential properties of suture materials Dyes and coatings to improve suture identification and properties References Appendix: further information on sutures Materials for absorbable and nonabsorbable surgical sutures 275 C. C. Chu, Cornell University, USA 11.1 Introduction Natural materials for absorbable sutures Synthetic materials for absorbable sutures Materials for nonabsorbable sutures Future trends Sources of further information and advice References Appendix: further information on sutures Surgical knot performance in sutures 335 B. S. Gupta, North Carolina State University, USA 12.1 Introduction Tensile properties of knotted sutures Knot strength Performance in dynamic tests Knot security Friction in sutures and friction-based hypothesis of knot security The use of lasers to improve knot security The use of tissue adhesive to improve knot security Conclusion Acknowlegements References 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 The development of barbed sutures 368

7 x Contents 13.3 Materials for barbed sutures Barbed suture design and manufacture Testing and characterization Properties of barbed sutures Surgical techniques using barbed sutures Applications of barbed sutures Sources of further information and advice Acknowledgement References Small-diameter arterial grafts using biotextiles 408 B. S. Gupta, North Carolina State University, USA 14.1 Introduction Understanding compliance Tests for compliance Testing compliance in practice: a case study Engineering small-diameter vascular grafts by weaving Using elastomeric threads to construct small-diameter vascular grafts Summary Acknowledgements References 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 Arterial pathologies The development of modern vascular surgery Vascular grafts of biological origin Vascular prostheses from synthetic polymers and biopolymers Improving current vascular prostheses 462

8 Contents xi 15.7 Conclusion References Biotextiles as percutaneous heart valves 485 F. Heim and B. Durand, Universite de Haute-Alsace, France and N. Chakfe, Hopitaux Universitaires de Strasbourg, France 16.1 Introduction Heart valve replacement: critical issues Textile valves: manufacturing requirements Textile valves: in vitro performance Textile valves: long-term performance Textile valves: in vivo performance Conclusions and future trends References Biotextiles as vena cava filters 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 Current filters for embolic protection in the IVC An ideal'ivc filter design References 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 Anatomy and physiology of a normal functioning heart Epidemiology, pathology, incidence and patient population ol'asds Historical methods of ASD repair Current noninvasive treatments, therapies and devices used to repair ASDs Advantages and disadvantages of the current technology 553

9 xii Contents 18.7 Future trends Conclusion Sources of further information and advice References Hemostatic wound dressings 563 C. R. Gajjar, M. G. McCord and M. W. King, North Carolina State University, USA 19.1 Introduction The importance of hemostatic textiles Understanding the clotting of blood Influence of foreign surfaces on blood clotting Existing hemostatic materials Future trends References Anterior cruciate ligament prostheses using biotextiles 590 M. Laflamme, J. Lamontagne and R. Guidoin, Laval University, Canada 20.1 Introduction Anatomy and structure of the anterior cruciate ligament (ACL) Biomechanics of the ACL Clinical problems associated with the ACL Diagnosis and treatment of ACL ruptures Autograft for ACL reconstruction Allograft for ACL reconstruction Graft healing in ACL reconstructive surgery The use of synthetic materials and prostheses in ACL reconstructive surgery Complications with synthetic ligaments Augmentation devices Tissue engineering and scaffolds Xenografts Conclusion References 629

10 Contents xiii 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 History and advantages of stent grafts Stent graft design and performance Prefenestrated devices for juxtarenal aneurysms Novel approaches to the treatment of juxtarenal and suprarenal aneurysms Conclusion References 672 Index 677