BIOMEDICAL DEVICES: DESIGN, PROTOTYPING, AND MANUFACTURING

BIOMEDICAL DEVICES: DESIGN, PROTOTYPING, AND MANUFACTURING

Editorial:
WILEY-BLACKWELL
Año de edición:
Materia
Biomateriales
ISBN:
978-1-118-47892-9
Páginas:
208
N. de edición:
1
Idioma:
Inglés
Disponibilidad:
Disponible en 2-3 semanas

Descuento:

-5%

Antes:

117,73 €

Despues:

111,84 €

CONTRIBUTORS ix
FOREWORD xi
• 1 Overview 1
Joaquim De Ciurana Gay, Tu¢grul Özel, and Lidia Serenó
1.1 Introduction, 1
1.2 Need for Medical Devices, 7
1.3 Technology Contribution to Medical Devices, 12
1.3.1 Subtractive Technologies, 13
1.3.2 Net-Shape Technologies, 13
1.3.3 Additive Technologies, 14
1.4 Challenges in the Medical Device Industry, 16
References, 17
• 2 Design Issues in Medical Devices 23
Inés Ferrer, Jordi Grabalosa, Alex Elias-Zuñiga, and Ciro Angel Rodriguez
2.1 Medical Device Development (MDD), 23
2.1.1 Biomedical Product Life Cycle, 24
2.1.2 Medical Device Development Process, 27
2.1.3 Medical Devices’ Design Process, 28
2.2 Case Study, 30
2.2.1 Scapholunate Interosseous Ligament, 30
2.2.2 Conceptual Design, 32
2.2.3 Embodiment Design, 35
2.2.4 Detailed Design, 36
2.2.5 Manufacturing a Prototype, 36
2.2.6 Tracheal Stent, 38
2.2.7 Conceptual Design, 39
2.2.8 Embodiment Design and Detail Design, 43
2.2.9 Manufacturing a Prototype, 45
2.3 Conclusions, 45
References, 46
• 3 Forming Applications 49
Karen Baylón, Elisabetta Ceretti, Claudio Giardini, and Maria Luisa Garcia-Romeu
3.1 Forming, 49
3.2 Typical Process Parameters, 52
3.2.1 Temperature, 52
3.2.2 Flow Stress, 53
3.2.3 Strain, 53
3.2.4 Strain Rate, 54
3.2.5 Tribology and Micro-Tribology, 54
3.3 Manufacturing Process Chain, 55
3.3.1 Manufacture of Alloys and Raw Materials, 55
3.3.2 Forming, 56
3.3.3 Machining and Finishing, 56
3.3.4 Coating, 56
3.3.5 Packaging and Sterilization, 56
3.4 Implantable Devices, 56
3.5 Bone Implants, 57
3.5.1 External Fracture Fixation, 57
3.5.2 Artificial Joint Replacement, 58
3.5.3 Spinal Implants, 68
3.5.4 Craniomandibular Implants, 68
3.5.5 Dental Implants, 71
3.6 Other Biomedical Applications, 73
References, 74
• 4 Laser Processing Applications 79
Tu¢grul Özel, Joaquim De Ciurana Gay, Daniel Teixidor Ezpeleta, and Luis Criales
4.1 Introduction, 79
4.2 Microscale Medical Device Applications, 80
4.3 Processing Methods for Medical Device Fabrication, 82
4.4 Biomaterials Used in Medical Devices, 86
4.5 Microjoining of Similar and Dissimilar Materials, 86
4.6 Laser Micromachining for Microfluidics, 89
4.7 Laser Micromachining for Metallic Coronary Stents, 92
References, 94
• 5 Machining Applications 99
Tu¢grul Özel, Elisabetta Ceretti, Thanongsak Thepsonthi, and Aldo Attanasio
5.1 Introduction, 99
5.2 Machinability of Biocompatible Metal Alloys, 102
5.3 Surfaces Engineering of Metal Implants, 104
5.4 Wear and Failure of Metal Implants, 105
5.5 Micromilling-Based Fabrication of Metallic Microchannels for Medical Devices, 106
5.6 Machining-Based Fabrication of Polymeric Microneedle Devices, 109
5.7 A Case Study: Milling-Based Fabrication of Spinal Spacer Cage, 110
5.7.1 Degenerative Disc Disease, 112
5.7.2 Intervertebral Spinal Spacers, 113
5.7.3 Prototype Fabrication Using Milling Process, 115
References, 118
• 6 Inkjet- and Extrusion-Based Technologies 121
Karla Monroy, Lidia Serenó, Joaquim De Ciurana Gay, Paulo Jorge Bártolo, Jorge Vicente Lopes Da Silva, and Marco Domingos
6.1 Introduction, 121
6.2 Inkjet Technology, 124
6.2.1 Inkjet 3D Printing Technology, 125
6.2.2 Materials in Inkjet-Based Technologies, 128
6.2.3 Inkjet Printing Methods, 130
6.2.4 Inkjet Printing Systems: Processes and Machines, 131
6.2.5 Medical Applications of Inkjet Technology, 135
6.3 Material Extrusion Technology, 139
6.3.1 Material Extrusion—General Principles, 139
6.3.2 Extrusion-Based Technologies, 144
6.3.3 Medical Applications of Extrusion-Based Systems, 153
References, 156
• 7 Certification for Medical Devices 161
Corrado Paganelli, Marino Bindi, Laura Laffranchi, Domenico Dalessandri, Stefano Salgarello, Antonio Fiorentino, Giuseppe Vatri, and Arne Hensten
7.1 Introduction, 161
7.2 The Medical Devices Approval, Registration, or Certification, 163
7.3 The Premarket Key Activity: The Demonstration of the Conformity to the Safety and Performance Requirements, 163
7.4 The Postmarket Key Activity: The Surveillance, 165
7.5 The Role of the Quality Management Systems, 165
7.6 The Verification and the Auditing, 166
7.7 The Role of the Standards, 167
7.8 Examples of Approbation/Certification Roads in Some World Areas, 168
7.8.1 European Union, 168
7.8.2 United States of America, 168
7.8.3 Japan, 168
7.8.4 Australia, 169
7.8.5 Brazil, 169
7.8.6 Canada, 169
7.9 In-Depth Studies, 170
7.9.1 Essentials of Safety and Performance Principles, 170
7.9.2 Essentials of the Risk Management, 174
7.9.3 Essentials of the Nonclinical Evaluation, 175
7.9.4 Essentials of the Clinical Evaluation, 178
References, 181
INDEX 183

With biomedical instrumentation playing such a critical role in modern day medicine and health care, it is becoming increasingly important to gain a thorough understanding of the design, construction, and patient interactions of medical devices. Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. After a broad overview of medical devices and information on material processes and regulations, chapters provide in-depth coverage of the design, prototyping, manufacturing, and application of various medical devices. Individual topics include biomaterials and their properties; design issues with case studies; modeling, and analysis; prototyping technologies for medical devices; forming applications; laser processing applications; machining applications; extrusion and inkjet based processes and applications; finishing processes; and issues in certification of medical device technologies. Some of the specific medical applications discussed include tracheal stents, biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures, and many more. Comprehensive and thoroughly up to date, Biomedical Devices: Design, Prototyping, and Manufacturing is an invaluable resource for those seeking an understanding of the principles, design, and applications of medical device technology.á