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Andrés Díaz Lantada

A.I Summary of Especially Relevant References Linked to the Contents Covered in the Present Handbook

1. Altshuller, G.: The Innovation Algorithm: TRIZ, Systematic Innovation and Technical Creativity. Worcester, MA (1999)

2. Ashby, M.F.: Materials Selection in Mechanical Design. Butterworth- Heinemann, 3rd edn. (2005)

3. Ashby, M.F., Jones, D.R.H.: Engineering Materials 1. Butterworth Heineman, 2nd edn. (1996)

4. Ashby, M.F., Jones, D.R.H.: Engineering Materials 2. Butterworth Heineman, 2nd edn. (1998)

5. Bar-Cohen, Y.: Electroactive Polymer (EAP) Actuators as Artifi cial Muscles: Reality, Potential and Challenges. SPIE Press, 2nd edn. Washington (2004)

6. Benyus, J.M.: Biomimicry. Innovation Inspired by Nature. Harper Collins Publishers (2002)

7. Brinker, C.J., Scherer, G.W.: Sol–Gel Science: The Physics and Chemistry of Sol–Gel Processing. Academic Press, 1st edn. (1990)

8. Bunshah, R.F.: Handbook of Deposition Technologies for Films and Coatings: Science, Technology and Applications. 2nd edn. Noyes Publications, Materials science and process technology series. Park Ridge, NJ (1994)

9. Capolino, F.: Metamaterials Handbook. Vol. I: Theory and Phenomena of Metamaterials. Taylor and Francis (2009)

10. Capolino, F.: Metamaterials Handbook. Vol. II: Applications of Metamaterials. Taylor and Francis (2009)

11. Davis, J.R.: Handbook of Materials for Medical Devices. ASM International. United States (2003)

12. Díaz Lantada, A.: Handbook on Active Materials for Medical Devices: Advances and Applications. PAN Stanford Publishing (2012)

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356

13. Díaz Lantada, A., Lafont Morgado, P.: Rapid prototyping for biomedical engineering: current capabilities and challenges. Annu. Rev. Biomed. Eng. 14 , (2012)

14. Drexler, E.: Engineers of Creation: The Coming Era of Nanotechnology. Anchor Books, 1986, Oxford University Press (1990)

15. Drexler, E.: Molecular Machinery and Manufacture with Applications to Computation. Ph.D Thesis, MIT (1991)

16. Feynman, R.P.: There’s plenty of room at the bottom (data storage)”. J. Microelectromech. Syst. 1 (1), 60–66, reprint of the talk, doi: 10.1109/84.128057 (1992)

17. Feynman, R.P.: Infi nitesimal machinery. J. Microelectromech Syst. 2 (1), 4–14, doi: 10.1109/84.232589 (1993)

18. Gad-el-Hak.: The MEMS Handbook. CRC Press. New York (2003) 19. Kucklick, T.R.: The Medical Device R&D Handbook. CRC Press (2006) 20. Lorenzo Yustos, H.: Aplicación de nuevas tecnologías en la realización de

herramientas para moldes de inyección de termoplásticos. Ph.D Thesis (Advisor: P. Lafont Morgado), Universidad Politécnica de Madrid (2008)

21. Madou, M.J.: Fundamentals of Microfabrication: The Science of Miniaturization. CRC Press, 2nd edn. (2002)

22. Maluf, N.: An Introduction to Micro-electromechanical Systems Engineering. Artech House (2000)

23. Mandelbrot, B.: The Fractal Geometry of Nature. W. H. Freeman, San Francisco (1982)

24. Mironov, V., Trusk, T., Kasyanov, V., Little, S., Swaja, R., Markwald, R.: Biofabrication: A 21st century manufacturing paradigm. Biofabrication 1 (2), 022001 (2009)

25. Pahl, G., Beitz, W.: Engineering Design: A Systematic Approach, 2nd edn. Springer Verlag, London (1996)

26. Roozenburg, N., Eeckels, J.: Product Design: Fundamentals and Methods. John Wiley & Sons, New York (1995)

27. Saaksvuori, A., Immonen, A.: Product Lifecycle Management, 3rd edn. Springer Verlag, Berlin/Heidelberg/London/New York (2008)

28. Schwarz, M.: New Materials Processes, and Methods Technology, 1st edn. CRC Press, Taylor & Francis Group (2005)

29. Stark, J.: Product Lifecycle Management: 21st Century Paradigm for Product Realisation. Springer Verlag, Berlin/Heidelberg/New York (2004)

30. Ulrich, K., Eppinger, S.: Product Design and Development. 4th Edition. Mc-Graw Hill/Irwin, New York (2007)

31. Varadan, V.K., Xiaonin Jiang, Varadan, V.V.: Microstereolithography and Other Fabrication Techniques for 3D MEMS. Wiley (2001)

32. Wohlers, T.: Wohlers’ Report: Additive Manufacturing State of the Industry. Wohlers Associates (2010)

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A.II Summary of Especially Relevant Websites

On Computer-Aided Design and Engineering Resources

More linked to design tasks: • http://usa.autodesk.com • http://usa.autodesk.com/3ds-max • http://usa.autodesk.com/autodesk-inventor • http://usa.autodesk.com/product-design-suite • http://www.3ds.com/es/products/catia • http://www.plm.automation.siemens.com/en_us/products/nx/nx8 • http://www.plm.automation.siemens.com/en_us/products/velocity/solidedge • http://www.rhino3d.com • http://www.solidworks.com

More linked to calculation tasks: • http://www.3ds.com/products/simulia/portfolio/abaqus/overview • http://www.ansys.com • http://www.comsol.com • http://www.mscsoftware.com/products/cae-tools/msc-nastran.aspx • http://www.mscsoftware.com/products/cae-tools/patran.aspx • http://www.mathworks.com

On Medical Imaging and Design Based on Medical Images • http://biomedical.materialise.com/mimics • http://biomedical.materialise.com/mis • http://www.amira.com • http://www.mathworks.com (Users community for open access software) • http://www.skyscan.be

On Additive Manufacturing (Rapid Prototyping) Resources • http://reprap.org/wiki/RepRap • http://www.3dsystems.com • http://www.additive3d.com • http://www.bitsfrombytes.com • http://www.digilabglobal.com • http://www.digilabglobal.com/celljet • http://www.dimensionprinting.com • http://www.envisiontec.de • http://www.fabathome.org • http://www.makerbot.com • http://www.nanoscribe.de • http://www.stratasys.com • http://www.zcorp.com/en/home.aspx

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On Micro- and Nano-manufacturing • http://e.drexler.com • http://www.ceramed.pt • http://www.efds.org • http://www.intelligentmp.com • http://www.nanoscribe.de • http://www.oxfordlasers.com • http://www.svc.org

On Systems for Characterization Trials and Biological Models • http://biomedical.materialise.com/anatomical-models • http://biomedical.materialise.com/heartprint • http://biomedical.materialise.com/other-anatomical-models • http://simbionix.com • http://worldwide.bose.com • http://worldwide.bose.com/electroforce/en/web/home/page.html • http://www.3bscientifi c.es • http://www.cae.com/en/healthcare/home.asp • http://www.simulab.com

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A.III Summary of Main Standards and Associations

Main Organizations • International Organization for Standarization “ISO” (www.iso.org) • The World Medical Association (www.wma.net)

“New Approach” Directives Related to the Medical Industry • Directive 93/42/EEC related to “Medical devices” • Directive 90/385/EEC related to “Active implantable medical devices” • Directive 98/79/EC related to “Medical devices for “in vitro” diagnosis”

Standards Related to the Development of Medical Devices • ISO 10993 standard on “Biological evaluation of medical devices” • ISO 13485 standard on “Sanitary products. Quality management and regulatory

affairs” • ISO 13488 standard on “Quality systems. Medical devices, sanitary products and

especial requirements for applying ISO 9002 standard” • ISO 14971 standard on “Application of risk management to medical devices and

sanitary products” • ISO 15223 standard on “Symbols used for labelling and information provided

together with medical devices”

Standards and Associations Related to Medical Imaging • DICOM standard – Digital Imaging and Communications in Medicine: Strategic

Document (http://medical.nema.org) • Medical Imaging and Technology Alliance (www.medicalimaging.org) • NEMA – The Association of Electrical and Medical Imaging Equipment

Manufacturers (www.nema.org)

Additional Documents of Interest • Council of Europe “Convention for the Protection of Human Rights and Dignity

of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine” (1994)

• UNESCO “Universal Declaration on the Human Genome and Human Rights” (1997) and “Guidelines for Implementation” (1999)

• World Medical Association “Declaration of Helsinki. Ethical principles for med-ical research involving human subjects” (current revised edition 2008)

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A.IV Relevant Scientifi c Journals Linked to Medical Devices and Related Topics of Interest

Listed below there are several high-quality scientifi c journals, linked to the different topics covered within the handbook, where researchers can fi nd additional informa-tion on biodevices and medical devices, as well as on recent advances on Materials Science and Technology for further promoting such advances:• “Acta Biomaterialia”, Elsevier • “Annals of Biomedical Engineering”, Springer • “Annual Review of Biomedical Engineering”, Annual Reviews • “Annual Review of Materials Research”, Annual Reviews • “Biochip Journal”, Springer • “Biofabrication”, IOP Publishing • “Bioinspiration & Biomimetics”, IOP Publishing • “Biomaterials”, Elsevier. • “Biomechanics and Modeling in Mechanobiology”, Springer • “Biomedical Engineering”, Springer • “Biomedical Engineering Letters”, Springer • “Biomedical Engineering Systems and Technologies”, Springer • “Biomedical Microdevices”, Springer • “Cardiovascular Engineering and Technology”, Springer • “Cellular and Molecular Bioengineering”, Springer • “Computer Methods in Biomechanics and Biomedical Engineering”, Taylor &

Francis • “IEEE Transactions on Biomedical Engineering”, IEEE • “International Journal of Biomedical Engineering and Technology”, Inderscience • “International Journal of Mechanics and Materials in Design”, Springer • “Journal of Applied Physics”, American Institute of Physics • “Journal of Biomedical Engineering”, Elsevier • “Journal of Biomimetics, Biomaterials and Tissue Engineering”, Scientifi c.net • “Journal of Materials Science: Materials in Medicine”, Springer • “Journal of Microelectromechanical Systems”, IEEE ASME • “Journal of Nano Research”, Scientifi c.net • “Journal of Physics D: Applied Physics”, IOP Science • “Journal of Tissue Engineering and Regenerative Medicine”, Wiley & Sons • “Materials & Design”, Elsevier • “Nature Materials”, Nature Publishing Group • “Nature Nanotechnology”, Nature Publishing Group • “Plasma Processes and Polymers”, Wiley & Sons • “Rapid Prototyping Journal”, Emerald • “Science Translational Medicine”, Science AAAS

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• “Science Signalling”, Science AAAS • “Sensors”, MDPI Publishing • “Sensors and Actuators A: Physical”, Elsevier • “Sensors and Actuators B: Chemical”, Elsevier • “Smart Materials and Structures”, IOP Publishing • “The Open Biomedical Engineering Journal”, Bentham Open • “Tissue Engineering: Parts A, B & C”, Mary Ann Liebert Inc.

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A.V Relevant Enterprises Linked to Medical Devices

Listed below there are several websites of multinationals and highly relevant com-panies linked to the development of medical devices, as a help for researchers need-ing information on conventional commercially available biodevices for their own development projects:• http://biomet3i.es • http://global.smith-nephew.com/master/6600.htm • http://integralife.com • http://www.3dbiotek.com/web • http://www.admedes.com • http://www.bbraun.de • http://www.biotronik.de • http://www.bostonscientifi c.com/home.bsci • http://www.clevemed.com • http://www.edwards.com • http://www.gehealthcare.com • http://www.gpc-medical.com • http://www.healthcare.philips.com • http://www.hitec-implants.com • http://www.insphero.com • http://www.jnj.com/connect • http://www.medical.siemens.com • http://www.medtronic.com • http://www.sfm.de • http://www.sjm.com • http://www.smiths-medical.com • http://www.sorin.com • http://www.spacelabshealthcare.com • http://www.stryker.com • http://www.valtronic.ch • http://www.zimmer.com • http://www.zyvex.com

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A.VI Some Matlab Programs for Helping Designers

Program for Designing Fractional Brownian Fractal Surfaces %Fractal surface (based on fractional Brownian fractal model)

clear all close all for ibis = 1:0.1:31 for jbis = 1:0.1:31 i=ibis*10; j=jbis*10; X(i)=ibis; Y(j)=jbis; sum = 0; lambda = 1.5; alfa = 0.8; % Fractal dimension is given by 3-alfa for n = 1:1:100 sum = sum + (random('norm',0,1))*(lambda^(− alfa*n))*sin((lambda^n)*(i*cos(2*pi*rand(1))+ + j*sin(2*pi*rand(1))+2*pi*rand(1)))/100; end Z(i,j)=sum; end end surface = surf(X,Y,Z)

Program for Fractal Surfaces Based on the Mandelbrot- Weierstrass Model % Mandelbrot-Weierstrass fractal surface

clear all, close all, clc; x=[0:0.1:10]; y=[0:0.1:10]; A=5; B=5; D=[0:0.5:2]; gamma=[1:1:4];

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z=zeros(length(x),length(y),length(gamma),length(D)); for jj=1:length(D) for ii=1:length(gamma) for i=1:length(x) for j=1:length(y) for n=1:50 z ( i , j , i i , j j ) = z ( i , j , i i , j j ) + A ^ ( D ( j j ) -

1)*cos(2*pi*gamma(ii)^n*x(i))/(gamma(ii)^((2- D(jj))*n))+B^(D(jj)- 1)*sin(2*pi*gamma(ii)^n*y(j))/(gamma(ii)^((2- D(jj))*n)); end end end end end fi gure; a=1; for i=1:length(D) for j=1:length(gamma) subplot(length(D),length(gamma),a) mesh(x,y,z(:,:,j,i));title(['D =', num2str(D(i),'%10.1f'),' Gamma =', num2str(gamma(j),'%10.1f')]); xlabel('x');

ylabel('y'); zlabel('surface'); a=a+1; end end

Program for Designing Fractal Spheres %Fractal spheres

clear all close all i = 0; j = 0; [X,Y,Z]=sphere(50); Xbis = X; Ybis = Y; Zbis = Z; l1=0; l2=0; for numespx=0:1:2 for numespy=0:1:2 for i = 1:1:51 for j=1:1:51

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radius = 1; lambda = 1.5; alfa = 0.1; sum = 0; for n = 1:1:5 sum = sum + (random('norm',0,1))*(lambda^(− alfa*n))*sin((lambda^n)+2*pi*rand(1))/5; end r=radius+sum; Xbis(i,j) = Xbis(i,j)*sqrt((r^2)/(Xbis(i,j)^2+ Ybis(i,j)^2+ Zbis(i,j)^2)); Ybis(i,j) = Ybis(i,j)*sqrt((r^2)/(Xbis(i,j)^2+ Ybis(i,j)^2+ Zbis(i,j)^2)); Zbis(i,j) = Zbis(i,j)*sqrt((r^2)/(Xbis(i,j)^2+ Ybis(i,j)^2+ Zbis(i,j)^2)); Xbis2(i,j) = Xbis(i,j)*40+l1*110; Ybis2(i,j) = Ybis(i,j)*40+l2*110; Zbis2(i,j) = Zbis(i,j)*40; end end surf(Xbis2, Ybis2, Zbis2) hold on l2=l2+1; end l2=0; l1=l1+1; end % surf(Xbis,Ybis,Zbis) surf(Xbis2, Ybis2, Zbis2) hold on

Program for Designing Fractal Circumferences (and Cylinders and Cones) %Fractal circumference

clear all close all i = 0; j = 0; k = 1; FI = 0; RO = 10; Z = 0; k = k+1; for fi = 0:3.1415/320:2*3.1415 j=j+1; radius = 10;

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lambda = 1.5; alfa = 0.2; sum = 0; for n = 1:1:20 sum = sum + (random('norm',0,1))*(lambda^(− alfa*n))*sin((lambda^n)+2*pi*rand(1))/10; end r = radius + sum; FI = [FI; fi ]; RO = [RO;r]; [Xint,Yint] = pol2cart(FI,RO); end plot(Xint,Yint)

Program for Designing Fractal Biomimetic Surfaces (Lotus Flower) %Fractal biomimetic surface

clc clear all close all i=0; j=0; for ibis = 1:0.1:30 i=i+1; j=0; for jbis = 1:0.1:30 j=j+1; X(i)=ibis; Y(j)=jbis; sum = 0; lambda = 1.5; alfa = 0.4; for n = 1:1:4 sum = sum + (random('norm',0,1))*(lambda^(− alfa*n))*sin((lambda^n)*(i*cos(2*pi*rand(1)) +j*sin(2*pi*rand(1))+2*pi*rand(1)))/10; end Z(i,j)=sum+10*abs(sin(pi*ibis/10)*sin(pi*jbis/10)); end end surface = surf(X,Y,Z)

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Program for Designing Microsystems with Fractal Channels %Fractal channels

clc clear all close all %Working in microns %Square 1 mm x 1 mm i=0; j=0; for ibis = 1:25:151 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis; sum = 0; lambda = 1.5; alfa = 0.9; for n = 1:1:3 sum = sum + (random('norm',0,1))*50*(lambda^(− alfa*n))*sin((lambda^n)*(i*cos(2*pi*rand(1)) + j*sin(2*pi*rand(1))+2*pi*rand(1))); end Z(i,j)=sum; end end for ibis = 152:25:302 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis; Z(i,j)=100; end end for ibis = 303:25:453 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis; sum = 0;

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lambda = 1.5; alfa = 0.5; for n = 1:1:3 sum = sum + (random('norm',0,1))*50*(lambda^(− alfa*n))*sin((lambda^n)*(i*cos(2*pi*rand(1)) + j*sin(2*pi*rand(1))+2*pi*rand(1))); end Z(i,j)=sum; end end for ibis = 454:25:604 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis; Z(i,j)=100; end end for ibis = 605:25:755 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis; sum = 0; lambda = 1.5; alfa = 0.1; for n = 1:1:3 sum = sum + (random('norm',0,1))*50*(lambda^(− alfa*n))*sin((lambda^n)*(i*cos(2*pi*rand(1)) + j*sin(2*pi*rand(1))+2*pi*rand(1))); end Z(i,j)=sum; end end for ibis = 756:25:906 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis;

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Z(i,j)=100; end end for ibis = 907:25:1057 i=i+1; j=0; for jbis = 1:25:4001; j=j+1; X(i)=ibis; Y(j)=jbis; Z(i,j)=0; end end

surface = surf(Y,X,Z)

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371A.D. Lantada (ed.), Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices, DOI 10.1007/978-1-4614-6789-2,© Springer Science+Business Media, LLC 2013

A Additive manufacturing technologies ,

183, 185 biodevices with fractal features , 194–200 for biomedical fi eld applications

active/intelligent materials , 187 implantable devices , 186 orthotic devices and technical helps ,

186–187 pathology diagnosis, biomodels

for , 186 surgical training/planning tasks,

biomodels for , 186 tissue engineering , 187

CAD design and prototypes, of microsystems , 195–197

cell motility studies , 195–197 in vitro/in vivo trials , 187

annuloplasty ring prototype , 188 gerotor-type micropump, 188 , 189 hollow structure prototypes , 192 peristaltic micropump, 189 , 190 scaffolds for cell culture and tissue

engineering , 191–194 stent prototype , 188 volumetric pump designs , 188, 189

operation principle , 182 RepRap project , 204 RP technologies , 182–183 scaffolds for tissue repair , 200–203

Aerogels , 216, 254 Analytic hierarchy process (AHP) , 299 ARTHRO Mentor VR training

simulator , 286 Artifi cial materials , 122 Artifi cial prosthesis

CAE active prosthesis , 147–149 FEM-based simulations , 140 hard tissue interaction , 159–160 hip prosthesis , 142–145 knee prosthesis , 141–143 scaffold for tissue repair , 145–147 soft tissue interaction , 160–162

hip machining processes MAHO MH 600 C , 170, 173 personalized design, femoral prosthesis ,

170–171 roughing process , 170, 174 simulation , 170, 172

Autodesk Inventor , 63–64

B Baese’s process, for plastic parts reproduction ,

183, 184 Beeswax casting process , 218–220 Bioabsorbable materials , 25–26 Bioactive materials , 26 Biocompatibility

ex vivo/in vivo testing , 289 medical devices , 28–29 structured biodevice development

methodology data types , 333 description , 332 factors , 332 ISO standard 10993–1 , 333

Biodegradable materials , 25–26 Biofabrication

biomanufacturing technologies Cell Jet Cell Printer , 271–273

Index

372

Biofabrication ( cont. ) 3D-Bioplotter™ , 270–271 laser printing, of cells , 269–270 synQUAD Technology , 273

biomimesis , 265–266 biomimetic CAD fi les , 262 biomimetic device development

digitalization approach , 267–269 fractional Brownian fractal model ,

266–268 medical imaging-based reconstruction ,

267–269 multi-scale mathematical model ,

266–268 prostheses design , 266–268

bioprinter concept , 262 complex geometry scaffolds , 262 3D biomaterial reconstruction, micro-CT

technology , 264, 265 research objectives , 263

Bio-inert materials , 25 Biomimesis , 265–266 Biomimetic device development

digitalization approach , 267–269 fractional Brownian fractal model ,

266–268 medical imaging-based reconstruction ,

267–269 multi-scale mathematical model , 266–268 prostheses design , 266–268

Blanther’s process, for layered topographic maps , 183, 184

BOSE ® ElectroForce® system , 281–283 Brainstorming technique , 297, 300 Brainwriting technique , 297, 300, 301 Bruxism, diagnosis/treatment of , 317, 318

C CAD. See Computer-aided design (CAD) CAE. See Computer-aided engineering

(CAE) CAM. See Computer-aided manufacturing

(CAM) CathLabVR Simulator , 287–288 CATIA. See Computer-aided three-

dimensional interactive application (CATIA)

Cell Jet Cell Printer , 271–273 Chemical vapour deposition (CVD)

process , 253 Computer-aided design (CAD) , 10–11

application fi elds , 52 Autodesk Inventor , 63–64

biomimetic design of skin artifi cial biostructures , 81 bioreplication techniques , 86 contact phenomena effects , 86 fi ltering effects , 84–85 functions , 80 high-resolution photographic

camera , 82 mesh-to-solid programs , 82 microtopographies and

microtextures , 80 physical prototypes , 81 schematic representation , 83 self-similarity , 79 stages of process , 84

CATIA , 63 design operations , 65 3D modelling packages , 51 evolution of scientifi c documents ,

52–53 fractal geometry

acetabulum of total hip prosthesis , 113

biomimetic design , 108, 110–111 design of structures , 111–112 fractal spheres , 112 fractional Brownian fractal surfaces ,

113–114 Google SketchUp, 67 industrial design , 60 issues , 61 Matlab , 66 modules , 64–65 Siemens PLM solutions , 61–62 solid-based operations , 67–70 Solid Edge , 62–63 solids and surfaces design , 61–62 SolidWorks , 63 surface operations , 70–73

Computer-aided engineering (CAE) , 11 analysis solver , 139 artifi cial prosthesis

active prosthesis , 147–149 FEM-based simulations , 140 hard tissue interaction , 159–160 hip prosthesis , 142–145 knee prosthesis , 141–143 scaffold for tissue repair , 145–147 soft tissue interaction , 160–162

corporal geometries and tissues aneurysm , 148–151 femur , 151, 152 fl uidic behavior of arterial bifurcation ,

155–157

Index

373

thermal ablation of mitral valve tissue , 158–159

vibratory effects on eye and eardrums , 151, 153–155

evolution of scientifi c documents , 52–53 post-processing , 139 preprocessing , 138 software modules and tools

coupled thermal–fl uid simulations , 140 dynamic response calculations , 140 mechanical components , 140, 141 stress calculation modules , 139

Computer-aided innovation (CAI) tools , 52 Computer-aided manufacturing (CAM) , 11

injection-molding processes advantages , 173 disadvantages , 175 fi ll time and part quality , 176, 177 gerotor-type internal gear pump,

175 –176 Moldfl ow , 175 polymeric materials , 172–173 properties , 174–175

machining processes MAHO MH 600 C , 170, 173 personalized design, femoral

prosthesis , 170–171 roughing process , 170, 174 simulation , 170, 172

Computer-aided three-dimensional interactive application (CATIA) , 63

Corrosion ceramics , 32 metals , 31–32 polymers , 32

Crawford slip writing method , 297 Creativity promotion tools

elaboration stage analytic hierarchy process , 299 mind maps , 299 morphological box technique , 299 originality and value , 298 PERT chart , 299 radar chart , 299

innovative projects , 296 inspiration stage

bioinspiration concept , 298 brainstorming technique , 297 brainwriting technique , 297 Crawford slip writing method , 297 KJ technique , 298 Lotus blossom technique , 298 Philips 6–6 technique , 297 SCAMPER , 298

TRIZ contradiction analysis , 298 intellectual property and technological

transfer in academia , 308 in industry , 307–308

invention licensing agreements , 308 spin-off company , 309 TRIZ methodology ( see TRIZ

methodology) Customer relationship management

(CRM) , 10 CVD process. See Chemical vapour deposition

(CVD) process

D 3D-Bioplotter™ , 270–271 Derwent Innovation Index database , 349–350 Design based on surface operations

annuloplasty ring , 72–73 cardiovascular surgery , 70–71 GeoForm model , 72 vascular stent , 71

Device personalization. See Personalized medical devices

Digital age , 50 Digital imaging and communication in

medicine (DICOM) , 77 Di Matteo’s process, for 3D surface/body

construction , 183, 184 Dip coating process , 255–256 Duran model , 72

E Elasticity-related issues , 31 ElectroForce® linear motor , 281–283 Electrolytic/electrochemical deposition

process , 256 Enterprise resource planning (ERP) , 10 Ethylene oxide sterilisation , 33 Ex vivo/in vivo testing , 278

biocompatibility assessment , 289 instrumented splint with piezoelectric

sensors , 290, 291 using DLC-coated rapid prototyped

scaffold , 289, 290

F Failure mode and effects analysis (FMEA)

method , 15 Failure trees , 14–15 Fatigue-related issues , 30

Index

374

Fractal geometry applications for biodevices , 97–98 CAD model

acetabulum of total hip prosthesis , 113 biomimetic design , 108, 110–111 design of structures , 111–112 fractal spheres , 112 fractional Brownian fractal surfaces ,

113–114 defi nition , 96 dimension , 96 manufacture of

photopolymerisable resins , 116 physical prototypes , 113, 114 surface topography , 114–115

models evolutive model , 107–110 fractional Brownian models , 106–107 Mandelbrot–Weierstrass equation ,

99–105 static and dynamic , 98

process scheme of biomimetic design , 116 Fractal scaffolds , 195, 198, 199 Fractional Brownian models , 106–107

G GeoForm model , 72 Gerotor-type micropumps , 188, 189 GI-BRONCH Mentor VR training

simulator , 286

H Haptic teleoperation , 285 Hot embossing technique , 234, 235 Hydrogels , 217

I Information and communication technologies

(ICT) , 49–50 Injection-molding processes, CAM

advantages , 173 disadvantages , 175 fi ll time and part quality , 176, 177 gerotor-type internal gear pump, 175 –176 Moldfl ow , 175 polymeric materials , 172–173 properties , 174–175

In silico testing , 278 Catia v.5 , 280 description , 279 ergonomical splint features, for aided

tracheotomy , 279–280

FEM-based simulation , 279 Intellectual property

structured biodevice development methodology , 323–324

and technological transfer in academia , 308 in industry , 307–308

In vitro testing , 278 compression test of rapid prototyped

scaffold , 281, 282 dynamic loading condition , 280 ElectroForce® linear motor , 281–283 haptic teleoperation , 285 impact , 281 shape-memory polymer annuloplasty

ring , 288 Simulab Corporation

double-layered intestine biomimetic replicas , 284

heart model biomimetic replicas , 284 TraumaMan system , 285

static loading condition , 280 thermal analyses , 281 thermomechanical analyses , 281 virtual reality , 285–288

Ionic self-assembled monolayering techniques , 256–257

Ion implantation , 257–258 ISO biocompatibility matrix , 333

K Kardar–Parisi–Zhang model , 107–110 KJ technique , 298

L Langevin model , 107–110 Langmuir–Blodgett technology , 256 Laser ablation , 257 Laser micromachining technique , 229–230 Layer manufacturing technologies (LMT) , 54.

See also Additive manufacturing technologies

Lost-wax casting process , 220–221 Lotus blossom technique , 298, 301, 302

M Mandelbrot–Weierstrass equation , 99–105 Manufacturing technologies and materials

science layer-by-layer manufacturing processes , 54 rapid prototyping vs. rapid tooling , 54–55 scaffolds , 54

Index

375

Medical devices , 48 active materials , 23 ancient age , 20–21 bioabsorbable materials , 23 biocompatibility , 28–29 biomaterials , 25–27 body conditions , 26–28 corrosion and deterioration , 31–32 defi nition , 20 directive 98/79/EC , 39–41 directive 90/385/EEC , 39 directive 93/42/EEC , 37–38 human issues , 24 legal issues , 23–24 manufacturing techniques , 22 mechanical behaviour , 29–31 multidisciplinary teams , 34–35 physiological signs , 22 regulatory standards , 35 requirements , 24–25 socioeconomic factors , 22 standards , 35–36 sterilisation , 33–34 technical issues , 23 US Food and Drug Administration , 20

Medical imaging-aided design. See Personalized medical devices

Medical imaging technologies , 50–51 Metamaterials. See Porous and lattice

structures Microinjection molding process , 234 Micro-manufacturing technologies

additive complex 3D structures , 238 micro-stereolithography , 236–237 two-photon/ multiphoton lithography ,

237–238 applications , 227–228 cell scaffold prototypes , 242, 243 3D laser lithography technology

applications , 238–239 micro-/nano-fl uidic channels , 241, 242 polymeric micro-stents , 240, 241 ultrahigh-aspect-ratio microneedle ,

239, 240 EUMINAfab , 244 high-precision rapid manufacturing

process , 238, 239 lab-on-a-chip solutions , 229, 231, 238 life-on-a-chip/body-on-a-chip, 229 –231 microporous structures , 235–236 micro-replication , 233–235 photolithography , 230–233 schematic illustration , 226, 227

subtractive micromachining technologies , 228–230

Microporous structures, for prostheses and tissue engineering , 235–236

Micro-replication technologies , 233–235 Micro-stereolithography , 236–237 Mind maps , 299 Mitral valve insuffi ciency , 72, 317, 319 Morphological box technique , 299 Multiphoton lithography , 237 Munz’s layered photopolymerization process ,

183, 184

N Nano-manufacturing technologies

conventional implants , 249–250 CVD process , 253 ionic self-assembled monolayering

techniques , 256–257 ion implantation , 257–258 laser ablation , 257 PVD process , 250–252 solution-deposition process

dip coating , 255–256 electrolytic/electrochemical

deposition , 256 Langmuir–Blodgett technology , 256 sol–gel process , 254–255 spin coating , 255

Nanoscribe’s 3D laser lithography technology applications , 238–239 micro-/nano-fl uidic channels , 241, 242 polymeric micro-stents , 240, 241 ultrahigh-aspect-ratio microneedle ,

239, 240 Nanotechnology , 248, 249 NX , 61–62

O Oxford Lasers , 229–230

P Patent-based problem-based learning

(P 2 B 2 L) , 345 PBL. See Project-based learning (PBL) Peristaltic micropumps , 189, 190 Personalized medical devices

advantages of , 76–77 artifi cial hip prosthesis ( see Artifi cial

prosthesis) biomimetic CAD design of skin

Index

376

Personalized medical devices ( cont. ) artifi cial biostructures , 81 bioreplication techniques , 86 contact phenomena effects , 86 fi ltering effects , 84–85 functions , 80 high-resolution photographic

camera , 82 mesh-to-solid programs , 82 microtopographies and microtextures , 80 physical prototypes , 81 schematic representation , 83 self-similarity , 79 stages of process , 84

imaging tools DICOM standard , 77 MIMICS-like programs , 78–79 rapid prototyping technologies , 78 types of radiation , 77

prosthesis hard tissue , 87–89 soft tissue , 89–91

PERT chart. See Program evaluation review technique (PERT) chart

Philips 6–6 technique , 297 Photolithography, for 2D ½ biodevices ,

230–233 Physical vapour deposition (PVD) process ,

250–252 Porous and lattice structures , 122

Ashby’s diagrams , 126 Boolean operations with CAD design ,

124–125 CES Selector , 126 3D complex structures

additive manufacturing , 132 properties , 133 prototyping process , 133

FEM-based simulations , 125 geometrical confi gurations , 123–124 lattice auxetic structures and devices

annuloplasty ring , 129 Boolean CAD operations , 129–130 2D and 3D structures , 127–128 FEM simulation , 129–131 negative Poisson ratio , 126 shape-memory alloys , 128 smart actuators , 127

NetFabb , 123–124 schematic process , 123

Problem-based learning. See Project-based learning (PBL)

Product and portfolio management (PPM) , 10 Product data management (PDM) , 11

Product development basic engineering stage

approach , 9 level prototypes , 11–12 manufacturing and rapid prototyping

technologies , 11 shapes and geometries , 8 software programs , 10–11 tools , 10

conceptual design stage , 7–8 defi ning objectives and planning stage , 6–7 defi nition , 2 designers , 3 design steps , 6 detailed engineering stage , 12–13 diagram for product design , 13 factors , 5–6 new approach directives , 14 principles , 6 productivity , 13 quality , 14–15 safety , 13 systematic methodologies in

engineering , 4–5 types of engineer , 2

Product lifecycle management (PLM) development , 10 Siemens PLM solutions , 61–62

Program evaluation review technique (PERT) chart , 299

Project-based learning (PBL) conceptual design phases , 344, 345 in mechanical engineering fi eld , 342, 343 pre-commercial detailed design , 345 product development-related courses , 344 results

CAD–CAE tool handling , 352 patents usage , 351–352 students’ development tasks , 352–353 students’ marks evolution , 353 success rate , 352 workload, for teaching staff , 353

student motivation , 342, 343 teaching–learning tool , 342 teaching methodology, bioengineering

subject Actúa-UPM fl agship programme , 351 conceptual design examples, of medical

devices , 348, 349 customer/supplier communications , 350 Derwent Innovation Index database ,

349–350 development tasks , 345 different patent documents , 345, 346

Index

377

face-to-face classes , 347 industrial context , 347 multilingual working environment , 348 question format, for application task ,

347–348 students creativity , 350

PVD process. See Physical vapour deposition (PVD) process

Q Quality function deployment (QFD) , 14

R Radar chart , 299 Rapid form/shape copying process , 54

benefi ts , 209–210 description , 208 silicone mould manufacture , 210

after cutting/separation, of two mould cavities , 211, 212

after degasifi cation , 211 bicomponent liquid mixture , 211 cell growth and tissue engineering-

related studies , 217–219 cell motility studies , 217, 219 dimensional verifi cation , 217 one-part silicon mould making process ,

217, 218 polymerisation process , 211 prototypes from beeswax casting ,

218–220 vacuum casting , 211–214

sol–gel process agar gel fi lm , 214–215 characterisation , 214 micro-textured gel replicas , 215, 216

Rapid prototyping (RP) technologies , 182–183. See also Additive manufacturing technologies

Rapid tooling process benefi ts , 209–210 bridge tooling , 209 description , 208 soft and hard tooling , 209

RP technologies. See Rapid prototyping (RP) technologies

S Scaffold(s). See also Fractal scaffolds

for cell culture and tissue engineering , 191–194

design , 68–70 Matlab-based CAD designs, of

microtextured , 202 for tissue repair , 200–203

SCAMPER , 298 Shape-memory polymers

annuloplasty ring prototype , 188 stent prototypes , 188

Siemens PLM solutions , 61–62 Silicone mould manufacture , 210

after cutting/separation, of two mould cavities , 211, 212

after degasifi cation , 211 bicomponent liquid mixture , 211 cell growth and tissue engineering-related

studies , 217–219 cell motility studies , 217, 219 dimensional verifi cation , 217 one-part silicon mould making process ,

217, 218 polymerisation process , 211 prototypes from beeswax casting , 218–220 vacuum casting , 211–214

Simulab Corporation, in vitro testing double-layered intestine biomimetic

replicas , 284 heart model biomimetic replicas , 284 TraumaMan system , 285

Soft lithography , 233 Sol–gel process

advantages , 255 conventional stages , 254 rapid form/shape copying systems

agar gel fi lm , 214–215 characterisation , 214 micro-textured gel replicas , 215, 216

Solid Edge , 62–63 SolidWorks , 63 Solution-deposition process

dip coating , 255–256 electrolytic/electrochemical deposition , 256 Langmuir–Blodgett technology , 256 sol–gel process , 254–255 spin coating , 255

Spin coating process , 255 Sterilisation

ethylene oxide , 33 gamma ray radiation , 33–34 low temperature plasma , 34 steam , 33

Sterility assurance limit , 33 Structured biodevice development

methodology basic engineering stage

Index

378

Structured biodevice development methodology ( cont. )

CAD-CAE-CAM technologies , 328 integrating patent information , 326 in vitro tests , 329 modelling and simulation technologies ,

327–328 quality requirements , 330 rapid prototyping and manufacturing

technologies , 328–329 safety requirements , 330

biocompatibility data types , 333 description , 332 factors , 332 ISO standard 10993–1 , 333

biomaterials/intelligent material , 327 selection characteristics , 321–322 supplier availability , 322–323

conventional product, success of , 323 ex vivo/in vivo tests , 331–332 information exchange , 336–337 initial document frameworks , 315–317 intellectual property protection , 323–324 international collaborations , 336 issues , 334–335 multidisciplinary teams

benefi ts , 314–315 limitations , 315

objectives and planning stage , 320 patent utilization, benefi ts of , 323–325 teaching–learning activities , 336–337 teaching requirements , 317–320

Subtractive micromachining technologies , 228–230

Supply chain management (SCM) , 10

T Test-related issues , 30 Thin-fi lm solution-deposition process.

See Solution-deposition process TRIZ methodology

vs. brainwriting technique , 306, 307 computer-aided innovation tools , 304 inventive principles , 303–306 prostheses design and long-lasting

behavior , 304–305 schematic description , 303, 304

V Vacuum casting, for silicone mould

preparation , 211–214 Vibratory effects

eardrum , 153, 155 eye , 153, 154

Virtual reality (VR) , 285–288

W Wear-related issues , 30–31

X Xerogels , 216, 254

Index