T. Özel

Biomedical Devices

Design, Prototyping, and Manufacturing
Herausgeber: Özel, Tugrul; Da Silva, Jorge Vicente Lopes; Rodriguez, Ciro Angel; Gay, Joaquim De Ciurana; Ceretti, Elisabetta; Bártolo, Paolo Jorge

• Gebundenes Buch

Produktbeschreibung

The first book to discuss the design, prototyping, and manufacturing of medical devices all in one comprehensive source, Biomedical Devices explores why and how these devices are made and serves as the go-to reference source for students, doctors, scientists, and technicians researching the development and applications of these products. This ready reference provides an introduction to medical devices, followed by the design, manufacturing, and applications of these devices. Examples of medical applications discussed include: tracoidal stents, biopsy micro forceps, mirco-needle arrays, wrist implants, spinal spacers, and fixtures.

Produktdetails

• Verlag: Wiley & Sons / Wiley-Blackwell
• Artikelnr. des Verlages: 1W118478920
• 1. Auflage
• Seitenzahl: 208
• Erscheinungstermin: 24. Oktober 2016
• Englisch
• Abmessung: 244mm x 159mm x 20mm
• Gewicht: 440g
• ISBN-13: 9781118478929
• ISBN-10: 1118478924
• Artikelnr.: 39126896

Autorenporträt

Tugrul Özel is the Director of Manufacturing & Automation Research Laboratory and a Professor in the Department of Industrial & Systems Engineering at Rutgers University in the USA. Paulo Bártolo is Chair of Advanced Manufacturing Processes, Director of the Manchester Biomanufacturing Centre, and a Professor at the School of Mechanical, Aerospace and Civil Engineering, University of Manchester in the UK. Elisabetta Ceretti is a Professor in the Department of Mechanical and Industrial Engineering at the University of Brescia in Italy. Joaquim De Ciurana Gay is a Professor in the Department of Mechanical and Industrial Construction at the University of Girona in Spain. Ciro Angel Rodriguez is Director of the Center of Innovation and Strategic Products Design and a Professor at Tecnológico de Monterrey in Mexico. Jorge Vicente Lopes Da Silva is Director of the Center for Information Technology Renato Archer in Brasil.

Inhaltsangabe

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