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Joining and Assembly of Medical Materials and Devices

Joining and Assembly of Medical Materials and Devices
  • Author : Y N Zhou,M D Breyen
  • Publisher :Unknown
  • Release Date :2013-05-31
  • Total pages :574
  • ISBN : 9780857096425
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Summary : As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications. Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications. Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives

Joining and Assembly of Medical Materials and Devices

Joining and Assembly of Medical Materials and Devices
  • Author : B. Goss
  • Publisher :Unknown
  • Release Date :2011-01-15
  • Total pages :229
  • ISBN : 1439833508
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Summary :

Durability and Reliability of Medical Polymers

Durability and Reliability of Medical Polymers
  • Author : Mike Jenkins,Artemis Stamboulis
  • Publisher :Unknown
  • Release Date :2012-08-13
  • Total pages :296
  • ISBN : 9780857096517
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Summary : Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers. Part one provides a review of the types and properties of bioresorbable medical polymers. The effect of molecular structure on properties is discussed, along with the processing of bioresorbable and other polymers for medical applications. Transport phenomena and the degradation of bioresorbable medical polymers are reviewed, before an exploration of synthetic bioresorbable polymers and their use in orthopaedic tissue regeneration. Part two goes on to explore the durability and reliability of non-bioresorbable medical polymers, and wear processes in polymer implants and ageing processes of biomedical polymers in the body are discussed in depth, before an investigation into manufacturing defects and the failure of synthetic polymeric medical devices. With its distinguished editors and international team of expert contributors, Durability and reliability of medical polymers is an essential tool for all materials scientists, researchers and engineers involved in the design, development and application of medical polymers, whilst also providing a helpful overview of the subject for biologists, chemist and clinicians. Comprehensively examines the performance of both bioresorbable and non-bioresorbable medical polymers Discusses the processing of bioresorbable and other polymers for medical applications, before reviewing the degradation of bioresorbable medical polymers Explores the durability and reliability of non-bioresorbable medical polymers and discusses wear processes in polymer implants and ageing processes of biomedical polymers in the body

Bioinspired Materials for Medical Applications

Bioinspired Materials for Medical Applications
  • Author : Lígia Rodrigues,Manuel Mota
  • Publisher :Unknown
  • Release Date :2016-09-24
  • Total pages :544
  • ISBN : 9780081007464
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Summary : Bioinspired Materials for Medical Applications examines the inspiration of natural materials and their interpretation as modern biomaterials. With a strong focus on therapeutic and diagnostic applications, the book also examines the development and manipulation of bioinspired materials in regenerative medicine. The first set of chapters is heavily focused on bioinspired solutions for the delivery of drugs and therapeutics that also offer information on the fundamentals of these materials. Chapters in part two concentrate on bioinspired materials for diagnosis applications with a wide coverage of sensor and imaging systems With a broad coverage of the applications of bioinspired biomaterials, this book is a valuable resource for biomaterials researchers, clinicians, and scientists in academia and industry, and all those who wish to broaden their knowledge in the allied field. Explores how materials designed and produced with inspiration from nature can be used to enhance man-made biomaterials and medical devices Brings together the two fields of biomaterials and bioinspired materials Written by a world-class team of research scientists, engineers, and clinicians

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher :Unknown
  • Release Date :2015-08-18
  • Total pages :256
  • ISBN : 9780081002919
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Summary : Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Modelling Degradation of Bioresorbable Polymeric Medical Devices

Modelling Degradation of Bioresorbable Polymeric Medical Devices
  • Author : J Pan
  • Publisher :Unknown
  • Release Date :2014-10-24
  • Total pages :260
  • ISBN : 9781782420255
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Summary : The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices. The final set of chapters look at advances in modelling biodegradation of bioresorbable polymers. This book is an essential guide to those concerned with replacing tests and experiments with modelling. Provides a comprehensive mathematical framework for computer modelling of polymers and polymeric medical devices that can significantly reduce the number of experiments needed. Reviews the fundamental methods of modelling degradation, and applies these to particular materials including amorphous bioresorbable polyesters, semicrystalline biodegradable polyesters, and composite materials made of biodegradable polyesters and triclcium phosphates

Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
  • Author : Stephen F. Amato,Robert M. Ezzell Jr
  • Publisher :Unknown
  • Release Date :2014-10-27
  • Total pages :202
  • ISBN : 9780857099204
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Summary : All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publisher :Unknown
  • Release Date :2012-10-26
  • Total pages :544
  • ISBN : 9780857096456
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Summary : Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance

Nanotechnology-Enhanced Orthopedic Materials

Nanotechnology-Enhanced Orthopedic Materials
  • Author : Lei Yang
  • Publisher :Unknown
  • Release Date :2015-07-28
  • Total pages :234
  • ISBN : 9780857098504
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Summary : Nanotechnology-Enhanced Orthopedic Materials provides the latest information on the emergence and rapid development of nanotechnology and the ways it has impacted almost every aspect of biomedical engineering. This book provides readers with a comprehensive overview of the field, focusing on the fabrication and applications of these materials, presenting updated, practical, and systematic knowledge on the synthesis, processing, and modification of nanomaterials, along with the rationale and methodology of applying such materials for orthopedic purposes. Topics covered include a wide range of orthopedic material formulations, such as ceramics, metals, polymers, biomolecules, and self-assemblies. Final sections explore applications and future trends in nanotechnology-enhanced orthopedic materials. Details practical information on the fabrication and modification of new and traditional orthopedic materials Analyzes a wide range of materials, designs, and applications of nanotechnology for orthopedics Investigates future trends in the field, including sections on orthopedic materials with bacterial-inhibitory properties and novel materials for the control of immune and inflammatory responses

Biomaterials and Medical Device - Associated Infections

Biomaterials and Medical Device - Associated Infections
  • Author : L Barnes,Ian Cooper
  • Publisher :Unknown
  • Release Date :2014-11-21
  • Total pages :278
  • ISBN : 9780857097224
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Summary : Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.

Diamond-Based Materials for Biomedical Applications

Diamond-Based Materials for Biomedical Applications
  • Author : Roger Narayan
  • Publisher :Unknown
  • Release Date :2013-03-19
  • Total pages :296
  • ISBN : 9780857093516
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Summary : Carbon is light-weight, strong, conductive and able to mimic natural materials within the body, making it ideal for many uses within biomedicine. Consequently a great deal of research and funding is being put into this interesting material with a view to increasing the variety of medical applications for which it is suitable. Diamond-based materials for biomedical applications presents readers with the fundamental principles and novel applications of this versatile material. Part one provides a clear introduction to diamond based materials for medical applications. Functionalization of diamond particles and surfaces is discussed, followed by biotribology and biological behaviour of nanocrystalline diamond coatings, and blood compatibility of diamond-like carbon coatings. Part two then goes on to review biomedical applications of diamond based materials, beginning with nanostructured diamond coatings for orthopaedic applications. Topics explored include ultrananocrystalline diamond for neural and ophthalmological applications, nanodiamonds for drug delivery systems, and diamond nucleation and seeding techniques for tissue regeneration. Finally, the book concludes with a discussion of diamond materials for microfluidic devices. With its distinguished editors and international team of expert contributors, Diamond-based materials for biomedical applications is an authoritative guide for all materials scientists, researchers, medical practitioners and academics investigating the properties and uses of diamond based materials in the biomedical environment. Presents the fundamental principles and novel applications of this versatile material Discusses the functionalization of diamond particles and surfaces, biotribology and biological behaviour of nanocrystalinediamond coatings and blood compatibility of diamond-like carbon coatings Reviews nanostructured diamond coatings for orthopaedic coatings

Switchable and Responsive Surfaces and Materials for Biomedical Applications

Switchable and Responsive Surfaces and Materials for Biomedical Applications
  • Author : Johnathan Zhang
  • Publisher :Unknown
  • Release Date :2014-12-11
  • Total pages :324
  • ISBN : 9780857097170
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Summary : Surface modification of biomaterials can ultimately determine whether a material is accepted or rejected from the human body, and a responsive surface can further make the material "smart" and "intelligent". Switchable and Responsive Surfaces and Materials for Biomedical Applications outlines synthetic and biological materials that are responsive under different stimuli, their surface design and modification techniques, and applicability in regenerative medicine/tissue engineering, drug delivery, medical devices, and biomedical diagnostics. Part one provides a detailed overview of switchable and responsive materials and surfaces, exploring thermo-responsive polymers, environmentally responsive polyelectrolytes and zwitterionic polymers, as well as peptide-based and photonic sensitive switchable materials. Further chapters include a detailed overview of the preparation and analysis of switchable polymer brushes and copolymers for biomedical application. Part two explores the biological interactions and biomedical applications of switchable surfaces, where expert analysis is provided on the interaction of switchable surfaces with proteins and cells. The interaction of stimuli-sensitive polymers for tissue engineering and drug delivery with biosurfaces is critiqued, whilst the editor provides a skillful study into the application of responsive polymers in implantable medical devices and biosensors. A comprehensive overview of switchable and responsive materials and surfaces Includes in depth analysis of thermo-responsive polymers, photonic sensitive materials and peptide-based surfaces Detailed exploration of biological interactions of responsive and switchable surfaces, covering stimuli-sensitive polymers for drug delivery, surfaces with proteins/cells and application of polymers in medical devices

Inhaler Devices

Inhaler Devices
  • Author : Polina Prokopovich
  • Publisher :Unknown
  • Release Date :2013-04-23
  • Total pages :192
  • ISBN : 9780857098696
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Summary : Given their direct impact on the health and quality of life for millions, inhalers represent a major turning point in the history of modern medicine. Inhaler devices: Fundamentals, design and drug delivery provides readers with an introduction to the fundamentals of inhaler technology, with a comprehensive discussion of the history of inhalers as well as a discussion on current research and development. Part one discusses the fundamentals and development of inhaler devices as well as drug formulations for inhalers. The treatment of asthma is also discussed. Part two reviews recent developments in drug formulation and nanotechnology for inhaler devices, emerging inhaler technology and possible future trends. Inhaler devices: Fundamentals, design and drug delivery is an essential design guide for good industrial practice, and will be an invaluable resource for those researching and treating conditions such as asthma; and those developing and manufacturing inhalation devices. Introduces the fundamentals of inhaler technology Discusses the history of inhalers as well as current research and development as well as possible future trends Considers the development of inhaler devices, drug formulations and discusses the treatment of asthma

Science and Principles of Biodegradable and Bioresorbable Medical Polymers

Science and Principles of Biodegradable and Bioresorbable Medical Polymers
  • Author : Xiang Cheng Zhang
  • Publisher :Unknown
  • Release Date :2016-09-22
  • Total pages :476
  • ISBN : 9780081003930
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Summary : Science and Principles of Biodegradable and Bioresorbable Medical Polymers: Materials and Properties provides a practical guide to the use of biodegradable and bioresorbable polymers for study, research, and applications within medicine. Fundamentals of the basic principles and science behind the use of biodegradable polymers in advanced research and in medical and pharmaceutical applications are presented, as are important new concepts and principles covering materials, properties, and computer modeling, providing the reader with useful tools that will aid their own research, product design, and development. Supported by practical application examples, the scope and contents of the book provide researchers with an important reference and knowledge-based educational and training aid on the basics and fundamentals of these important medical polymers. Provides a practical guide to the fundamentals, synthesis, and processing of bioresorbable polymers in medicine Contains comprehensive coverage of material properties, including unique insights into modeling degradation Written by an eclectic mix of international authors with experience in academia and industry

An Introduction To Biomaterials Science And Engineering

An Introduction To Biomaterials Science And Engineering
  • Author : A Sandeep Kranthi Kiran,Seeram Ramakrishna
  • Publisher :Unknown
  • Release Date :2021-04-22
  • Total pages :412
  • ISBN : 9789811228193
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Summary : This book presents a broad scope of the field of biomaterials science and technology, focusing on theory, advances and applications. It is written for those who would like to develop their interest and knowledge towards biomaterials or materials science and engineering. All aspects of biomaterials science are thoroughly addressed, from basic principles of biomaterials, organs and medical devices to advanced topics such as tissue engineering, surface engineering, sterilization techniques, 3D printing and drug delivery systems. Readers are also introduced to major concepts of surface modification techniques, and potential applications of different classes of biomaterials. Multiple-choice questions at the end of every chapter will be helpful for students to test their understanding of each topic, with answers provided at the end of the book.Ultimately, this book offers a one-stop source of information on the essentials of biomaterials and engineering. It is useful both as an introduction and advanced reference on recent advances in the biomaterials field. Suitable readers include undergraduate and graduate students, especially those in Materials Science, Biomedical Engineering and Bioengineering.

Biosynthetic Polymers for Medical Applications

Biosynthetic Polymers for Medical Applications
  • Author : Laura Poole-Warren,Penny Martens,Rylie Green
  • Publisher :Unknown
  • Release Date :2015-11-23
  • Total pages :358
  • ISBN : 9781782421139
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Summary : Biosynthetic Polymers for Medical Applications provides the latest information on biopolymers, the polymers that have been produced from living organisms and are biodegradable in nature. These advanced materials are becoming increasingly important for medical applications due to their favorable properties, such as degradability and biocompatibility. This important book provides readers with a thorough review of the fundamentals of biosynthetic polymers and their applications. Part One covers the fundamentals of biosynthetic polymers for medical applications, while Part Two explores biosynthetic polymer coatings and surface modification. Subsequent sections discuss biosynthetic polymers for tissue engineering applications and how to conduct polymers for medical applications. Comprehensively covers all major medical applications of biosynthetic polymers Provides an overview of non-degradable and biodegradable biosynthetic polymers and their medical uses Presents a specific focus on coatings and surface modifications, biosynthetic hydrogels, particulate systems for gene and drug delivery, and conjugated conducting polymers

Medical Biosensors for Point of Care (POC) Applications

Medical Biosensors for Point of Care (POC) Applications
  • Author : Roger J Narayan
  • Publisher :Unknown
  • Release Date :2016-08-21
  • Total pages :316
  • ISBN : 9780081000786
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Summary : Medical Biosensors for Point of Care (POC) Applications discusses advances in this important and emerging field which has the potential to transform patient diagnosis and care. Part 1 covers the fundamentals of medical biosensors for point-of-care applications. Chapters in part 2 go on to look at materials and fabrication of medical biosensors while the next part looks at different technologies and operational techniques. The final set of chapters provide an overview of the current applications of this technology. Traditionally medical diagnostics have been dependent on sophisticated technologies which only trained professionals were able to operate. Recent research has focused on creating point-of-care diagnostic tools. These biosensors are miniaturised, portable, and are designed to be used at the point-of-care by untrained individuals, providing real-time and remote health monitoring. Provides essential knowledge for designers and manufacturers of biosensors for point-of-care applications Provides comprehensive coverage of the fundamentals, materials, technologies, and applications of medical biosensors for point-of-care applications Includes contributions from leading international researchers with extensive experience in developing medical biosensors Discusses advances in this important and emerging field which has the potential to transform patient diagnosis and care

Biomaterials and Regenerative Medicine in Ophthalmology

Biomaterials and Regenerative Medicine in Ophthalmology
  • Author : Traian Chirila,Damien Harkin
  • Publisher :Unknown
  • Release Date :2016-04-23
  • Total pages :502
  • ISBN : 9780081001844
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Summary : Biomaterials and Regenerative Medicine in Ophthalmology, Second Edition, focuses on an aging population and the increasing instances of eye diseases. Biomaterials continue to be used for numerous medical devices for the restoration of eyesight, improving many patients’ quality of life. Consequently, biomaterials and regenerative medicine are becoming increasingly important to the advances of ophthalmology and optometry. This book provides readers with an updated and expanded look at the present status and future direction of biomaterials and regenerative medicine in this important field. Provides an integral and significant exploration of biomaterials and regenerative medicine, presenting crucial advances made in the fields of ophthalmology and optometry, such as the development of intraocular lenses and new applications for contact lens Presents a new and updated look at the future direction of biomaterials and regenerative medicine in this field Comprehensive coverage in a range of fields, including hydrogels, corneal tissue engineering, and stem cell therapies for the restoration of the ocular surface

Medical Modelling

Medical Modelling
  • Author : Richard Bibb,Dominic Eggbeer,Abby Paterson
  • Publisher :Unknown
  • Release Date :2014-12-13
  • Total pages :516
  • ISBN : 9781782423133
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Summary : Medical modelling and the principles of medical imaging, Computer Aided Design (CAD) and Rapid Prototyping (also known as Additive Manufacturing and 3D Printing) are important techniques relating to various disciplines - from biomaterials engineering to surgery. Building on the success of the first edition, Medical Modelling: The application of Advanced Design and Rapid Prototyping techniques in medicine provides readers with a revised edition of the original text, along with key information on innovative imaging techniques, Rapid Prototyping technologies and case studies. Following an overview of medical imaging for Rapid Prototyping, the book goes on to discuss working with medical scan data and techniques for Rapid Prototyping. In this second edition there is an extensive section of peer-reviewed case studies, describing the practical applications of advanced design technologies in surgical, prosthetic, orthotic, dental and research applications. Covers the steps towards rapid prototyping, from conception (modelling) to manufacture (manufacture) Includes a comprehensive case studies section on the practical application of computer-aided design (CAD) and rapid prototyping (RP) Provides an insight into medical imaging for rapid prototyping and working with medical scan data

Biophotonics for Medical Applications

Biophotonics for Medical Applications
  • Author : Igor Meglinski
  • Publisher :Unknown
  • Release Date :2015-06-29
  • Total pages :402
  • ISBN : 9780857096746
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Summary : Biophotonics for Medical Applications presents information on the interface between laser optics and cell biology/medicine. The book discusses the development and application of photonic techniques that aid the diagnosis and therapeutics of biological tissues in both healthy and diseased states. Chapters cover the fundamental technologies used in biophotonics and a wide range of therapeutic and diagnostic applications. Presents information on the interface between laser optics and cell biology/medicine Discusses the development and application of photonic techniques which aid the diagnosis and therapeutics of biological tissues in both healthy and diseased states Presents the fundamental technologies used in biophotonics and a wide range of therapeutic and diagnostic applications

Implantable Sensor Systems for Medical Applications

Implantable Sensor Systems for Medical Applications
  • Author : Andreas Inmann,Diana Hodgins
  • Publisher :Unknown
  • Release Date :2013-01-02
  • Total pages :544
  • ISBN : 9780857096289
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Summary : Implantable sensor systems offer great potential for enhanced medical care and improved quality of life, consequently leading to major investment in this exciting field. Implantable sensor systems for medical applications provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of these devices in a diverse range of medical applications. Part one reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, microassembly, electrode array design and fabrication, and the use of biofuel cells as sustainable power sources. Part two goes on to consider the challenges associated with implantable systems. Biocompatibility, sterilization considerations and the development of active implantable medical devices in a regulated environment are discussed, along with issues regarding data protection and patient privacy in medical sensor networks. Applications of implantable systems are then discussed in part three, beginning with Microelectromechanical systems (MEMS) for in-vivo applications before further exploration of tripolar interfaces for neural recording, sensors for motor neuroprostheses, implantable wireless body area networks and retina implants. With its distinguished editors and international team of expert contributors, Implantable sensor systems for medical applications is a comprehensive guide for all those involved in the design, development and application of these life-changing technologies. Provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of implantable sensor systems in a range of medical applications Reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, and microassembly Considers the challenges associated with implantable systems, including biocompatibility and sterilization