Index
abdominal aortic aneurysm (AAA), 363
acetal, 117
acrylic polymers, 114
acrylonitrile butadiene styrene (ABS), 117
active brazing joining techniques, 423–43
in vitro testing, 432–5
industrial processing, 435–9
arrangement of cylindrical samples within the fixture before brazing, 437
centre of a joint brazed with filler metal, 438
compositional EDS dot mapping of brazed joint, 439
edge of a joint brazed with filler metal, 438
EDS spectra of joint brazed with filler metal, 440
graphite-heating-elements vacuum brazing furnace, 436
temperature brazing cycle for filler metal number 39, 437
typical active brazing conditions, 436
knee prosthesis, 439–43
mechanical characterisation, 430–2
correspondence between test batches and filler metals, 431
four-point-bending fatigue strengths of brazed specimens, 432
four-point-bending static strengths of brazed specimens, 431
metallurgy, 423–30
chemical composition, melting, wetting behaviour and hardness of fillers, 425–6
four-point-bending-strength of coupons with filler metals, 427
quantitative SEM analysis at Ti6Al4V filler–metal interface, 428
quantitative SEM analysis of filler metal number 39, 428
residual stress management across Ti6Al4V and ZrO2 joint, 430
specimens of four-point-bending test, 430
active device test, 184
adherend, 454
Adherus, 472–4
Adherus Spine in use, 474
Adherus Dural Sealant, 473
Adherus Spinal Sealant, 473
hydrophobic recovery, 393–4
graph depicting water contact angles and O/C ratios measured by XPS, 39
interfacial entanglements diagram, 391
promotion, 395–7
chemical diagram of silane coupling agent, 397
diagram of adhesive joint incorporating primer film, 397
weak boundary layers, 394
wettability and surface energy, 390–2
contact angle diagram formed by drop of liquid on solid surface, 392
water droplet on uncleaned and cleaned moulded connector module, 392
Adhesion Durability Tester (ADT), 378
medical device adhesives benefits, limitations and typical applications, 42
adhesive failure, 454
adhesive forces, 375
adhesives, 454
bonding strategies for joining medical polymers, 370–402
adhesion mechanism, 388–94
adhesion promotion, 395–7
adhesive types used in medical devices, 397–401
joint design with adhesive, 371–88
air overpressure (AOP), 92
amalgam, 492
compared with semicrystalline, 306–7
glass transition temperature and melting temperature, 308
shear modulus and loss tangent of amorphous polymers, 306
shear modulus and loss tangent of semicrystalline polymers, 307
AngioSeal, 472
after implantation, 473
bone and tooth repair, 491–507
future trends, 506–7
arc suppression, 337
arc welding, 31
arcing, 337
Arrhenius relationship, 419
ASTM F1980–02, 386
ASTM G1, 199
ASTM G16, 198
ASTM G46, 187
ASTM G100, 188
ASTM G102, 187
austenitic stainless-steel alloys, 155–6
autoclaving See steam sterilisation
autogenous welding, 213
barium sulphate, 500
thermal effects, 156–7
microhardness tests, 157
beam delivery, 353–5
curtain laser, 354
laser beam and workpiece manipulation, 353
moving laser, 353–4
moving workpiece, 353
scanning laser, 354–5
simultaneous welding, 354
behavioural tests, 518–19
adhesive, 520–5
micro-tensile bond strength, 523–5
shear bond strength test, 521–3
tensile and shear stresses in compressive strength test, 519
bioburden, 83
biocompatibility, 21–3
usage, 479
biological surgical G.R.F, 477–8
advanced metal–ceramic joining techniques, 407–46
active brazing, 423–43
challenges, 409–15
direct and indirect bonded, 418–23
future trends, 443–5
mechanical, 415–17
bioresorption, 463–4
blend polymer, 309
blow hole, 228
schematic diagram, 229
bond, 454
bond strength, 454
modelling in dental adhesives, 514–30
behavioural adhesive tests, 520–5
classification of testing techniques, 518–20
future trends, 529–30
rationale for testing, 516–18
structural adhesive tests, 525–9
bone grafts, 499
antibacterial adhesives, 498–506
experimental bone cements, 503–6
materials used for repair, 499–503
bore See conical female cavity
brushite See dicalcium phosphate dihydrate
bubble test, 250
buffers, 337–8
burst test, 295
butt joint, 271
butyl, 117
calcium carbonate, 501
calcium phosphate, 495–6
calcium-phosphate cements, 501–3
structural integrity tests, 526–9
carbon dioxide lasers, 352
catheters, 362
laser and infrared bonding (welding) technology, 288–91
application for balloon and catheter bonding, 290
cell-adhesion analysis, 433
cell spreading, 16
cellulose acetate butyrate, 116
cellulose acetate propionate, 116
cellulose esters, 116
ceramics, 120–1
chemical vapour deposition (CVD), 418
chemical vapour dry-heat steriliser, 84
circular projection welding, 212
clamping, 355–6
system for through-transmission laser welding, 355
cleaning, 395–6
Clearfil Protect Bond, 496
cleavage, 373
cochlear implants, 58
coefficient of thermal expansion (CTE), 418
cohesive failure, 454
cohesive forces, 375
combustion synthesis (CS), 408
commercial biostable bio-derived sealants, 477–9
BioGlue, 478–9
biological surgical G.R.F (MicroVal), 477–8
tissue adhesives and sealants, 478
commercial resorbable bio-derived sealants, 475–7
fibrin sealants, 475–6
usage, 476
PEG/albumin, 476–7
clinical study of sealant applied over sutures, 477
tissue adhesives and sealants, 475
compatible combinations, 357
conical female cavity, 417
conical male cone, 416
continuous-conveyer process, 305
continuous seam sealing, 365
continuous welding, 305
copolymers, 267–8
current direct measurements, 187–96
data gathering, 196–8
surface-condition sample variables affecting weld-corrosion risk, 198
test specimen considerations, 197
data interpretation, 204–5
future trends, 206–7
instrumentation and equipment, 201–2
electrical test cell components, functions, and requirements, 203
electrical three-electrode corrosion test cell, 202
measurements, 183–7
environmental variables affecting weld-corrosion risk and implant conditions, 185
immersion tests, 184
mitigations, 205–6
weld-corrosion prevention strategies and considerations, 205
overview, 178–83
assessment goals, 183
medical device welds, 181–3
sample on a single metal piece, 180
types, 179–81
performance evaluation of metal medical device welds, 178–207
test sample preparation, 198–201
standardised test electrode and holder, 200
direct measurements, 187–96
EIS equivalent circuits, 195
galvanic corrosion test cell configuration, 193
impedance data sample, 195
polarisation resistance plot, 190
polarisation scan for a 304SST sample, 189
polarisation scans to predict the risk and rate of galvanic corrosion, 192
Tafel plot, 191
variables and effects of galvanic corrosion, 192
welding effect, 158–9
welded joints between feed through terminals and lead connector, 159
Corsodyl, 497
CoSeal Surgical Sealant, 471
cracking, 229–30
schematic diagram, 230
crossed-wire joint, 159–60
joint-quality characterisation, 159–60
common methods for measuring joint breaking force, 162
previous crossed-wire microwelding studies, 161
RMW and LMW of 316 LVM, 160
‘crunch the crown’ experiment, 519
cutting, 70–1
cyanoacrylates, 479–80
tissue adhesives and sealants, 480
defibrillators, 59–64
resistance weld between Ti and MP35N wire, 63
weld between Ti and MP35N, 63
welds and mechanical joints in a bradycardia or pacing lead, 62
welds and mechanical joints in a high-voltage tachycardia, 61
degating, 320
degradation rate, 458
classification of testing techniques, 518–20
behavioural tests, 518–19
structural integrity tests, 519–20
modelling bond strength, 514–30
behavioural adhesive tests, 520–5
product life cycle in evidence-based medicine, 515
product life cycle of a dental material, 515
rationale for testing, 516–18
dental composites, 492–3
dentine, 522–3
dicalcium phosphate anhydrous (DCPA), 501
die design, 333–6
non-planar and three dimensional complex, 334–5
die set design with two potential switching circuits, Plate VI
seal sample contains both flat seal and ring seal, 335
tear seal, 335–6
dielectric (RF) welding, 283
dielectric sealing, 327–8
diffusion brasing (DFB), 39
diffusion welding (DFW), 39
mounted on robot arm, 352
direct bonding techniques, 418–21
plot of diffusion bond strength vs CTE for various alumina combinations, 420
solid-phase bonding stage illustration of metals to ceramic, 419
double pulse resistance microwelding, 165–7
Pt-10% Ir to 316 LVM SS crossed-wire joints, 168
welding schedule, 167
down speed, 304
drawn-filled-tube (DFT), 56
drilling, 70–1
commercial dry-heat steriliser, 84
microbial inactivation kinetics-death value, 83
schematic diagram, 82
dumbbell specimen design, 523
DuraSeal Dural Sealant System, 465–7
application to an incision, 467
schematic diagram, 468
dynamic mechanical analysis (DMA), 383
dynamic recrystallisation, 149
e-beam, 90
radiation sterilisation, 287
elastic modulus, 384
hermetic sealing, 68–70
laser seam weld in a thin-walled titanium enclosure, 71
laser welding application showing surface tension effects, 70
overlap condition requirement to achieve full hermetic weld, 69
joint designs, 244–9
304 SS plate with partial penetration welds with helium–argon cover gas, 249
304 SS plate with partial penetration welds without cover gas, 249
overlap pulse requirement and penetration, 246
poor hermetic seam due to poor joint fit-up, 247
schematic diagram, 245
well-formed and polished hermetic seam, 248
electronic polarisation, 324
electrostatic bonding, 420–1
enclosure stress state, 257
Energy Dispersion Spectrum (EDS), 437
entanglement, 390
epoxy, 116
epoxy adhesives, 399
etchant, 494
ethylene oxide, 96–100
prehumidification ethylene oxide (EO) sterilisation cycle, 86
schematic diagram, 85
ethylene propylene diene monomer (EPDM), 117
Euro-cone, 416
excimer lasers, 35
Exoseal, 472
PLGA plug for vascular closure, 473
extrusion welding, 279
heat sealing/welding (impulse sealer), 272–3
impulse heat sealing process, 273
hot-gas welding, 278
schematic diagram, 279
hot-plate welding, 272
infrared welding, 273–7
extracellular matrix (ECM), 17
extrusion welding, 279
fatigue test, 432
Fenton’s reaction, 460–1
fibrin sealants, 475–6
filler materials, 308
filters, 268
finite element analysis (FEA), 526–7
finite element method (FEM), 309
fiuoropolymers, 288
fluorinated polymers, 115
usage, 468
FocalSeal S, 469
focused laser beams, 222–5
power density distribution of a high power Nd:YAG laser, 224
schematic diagram, 223
transverse electromagnetic mode of laser beam, 224
fracture toughness, 528
Fresnel absorption, 215
friction-stir welding (FSW), 37–8
friction welding, 36–8
friction-stir welding, 37
schematic diagram, 37
frictional heating, 280
fusion welding, 30
gamma irradiation, 90
gamma radiation sterilisation, 287
gas flow, 243
gas shielding, 33–4
gel time, 457–8
gelatin-resorcinol-formaldehyde-glutaraldehyde (GRFG), 477–8
gelatin resorcinol formaldehyde (GRF), 453
glass, 120–1
glass ionomer cements (GICs), 493
globular protein, 15
Gluetiss, 478
Gomori’s method, 433
grade, 309
guided tissue-regeneration membrane, 499–500
Hagen–Ruben relation, 216–17
heat-affected zone (HAZ), 157
heat sealing/welding, 272–3
heat sterilisation, 80
effect polymers, 100–5
heat welding, 123–4
heating, 324–7
dipole polarisation, 325–6
molecules exposed to the alternating electric field, 325
overall schematic of RF sealing process, 325
effects of frequency and temperature, 327
dielectric properties at different temperature and 30MHz frequency, 327
joint surface, 300–1
helium, 232
electronic enclosures, 68–70
laser seam weld in a thin-walled titanium enclosure, 71
laser welding application showing surface tension effects, 70
overlap condition requirement to achieve full hermetic weld, 69
leak rate determination based on helium content, 252–7
leak rate measurement, 249–52
physics of leak rate, 237–49
validation in welded metallic implantable medical devices, 236–57
horn design, 309–12
amplitude of vibration changes along the stack, 310
near-field and far-field ultrasonic welding, 312
resonant length and amplitude relationship (amplitude gain), 311
vibration mechanism of an ultrasonic-welding system, 311
vibration mode for larger horn, Plate V
hot-bar welding, 40–1
hot-gas welding, 278
Howell–Mann rate calculations, 254–5
calculation of helium leak rate based on air leak rate, 255
change in scaled helium leak rate vs. helium content, 256
hydrogen peroxide, 94–6
schematic diagram, 87
hydrophobic recovery, 393–4
hydroxyl ethyl methacrylate (HEMA), 494
Hytrel, 365
image-analysis system, 433
immersion test, 184
immunohistochemistry, 433
implant heating, 263
implant welding, 283–7
induction-implant welding, 284–5
IR/laser-implant welding, 286
microwave-implant welding, 285–6
resistive-implant welding, 285
hermetic seal validation in welded metallic, 236–57
leak rate determination based on helium content, 252–7
leak rate measurement, 249–52
physics of leak rate, 237–49
laser hermetic welding, 211–35
focused laser beams, 222–5
future trends, 233–5
hermetic-sealing technique, 212–14
laser conduction welding, 214–22
parameters, 225–8
requirements, 228–33
impulse sealer welding, 272–3
in vitro testing, 432–5
adhering cells on sample brazed with filler metal, 434
filler metals ranking, 435
indirect bonding techniques, 421–3
liquid-phase bonding stages to metals and ceramics, 422
induction-implant welding, 284–5
schematic diagram, 284
induction welding, 40
inductively coupled plasma–atomic emission spectroscopy (ICP–AES), 187
inductively coupled plasma–mass spectroscopy (ICP–MS), 187
industrial processing, 435–9
inflatable devices, 365
prototype neck brace undergoing testing, 366
infrared welding, 273–7
IR heating absorption efficiency of polyethylene with carbon black levels, 276
IR lamp near infrared wavelength transmission of transparent polymers, 275
non-contact, 274
single and modified multiple focusable IR spot lamps, Plate III
through-transmission infrared welding of plastics, 276
typical wavelength distribution for quartz halogen IR lamp, 274
injectable degradable composites, 505–6
injectable degradable polymers, 503
insertion, 318–19
interfacial free energy, 9
interfacial surface tension, 8
intermolecular forces, 389
dielectric (RF) welding, 283
spin welding, 280
ultrasonic welding, 281–3
schematic diagram, 282
vibration welding, 280–1
Invibio®, 366
ionic polarisation, 324
ionisation, 6
ionising radiation, 88
IR/laser-implant welding, 286
adhesive bonding, 41–3
applications samples, 43–5
laser welding in intraocular lenses, 43
laser welding of surgical parts, 44
laser welding of dissimilar joints in knee prostheses, 45
laser welding of endoscopes, 44
medical applications, 28–45
overview, 28–33
welding process classification, 30
platinum alloy and stainless steel wires for electronic medical devices, 154–74
crossed-wire joint, 159–60
future trends, 174
material joining challenges, 156–9
material properties, 155–6
material properties (annealed condition), 155
processes, 162–73
welding processes, 33–41
joint breaking force (JBF), 145
accelerated testing of adhesive joints, 386–8
load generated for joint testing, 388
adhesive, 371–88
loading conditions for adhesive joint, 372
adhesive joint failure, 374
considerations, 314–15
designs suitable for transmission laser welding, 359
energy director, 315–16
cross-section of joint interface from an energy director joint design, 316
tongue and groove joint design, 315
general guideline on dimension and tolerance, 314
measuring work of adhesion (G0), 375–82
acetoxy cured silicone medical adhesive, 376
adhesive bond loaded at 45 ° peel load, 379
ADT test measures the crack growth rate over time, 379
cohesive and adhesive failure sample, 382
configuration for flexible medical adhesive bonded to rigid substrate, 378
failure force as failure rate function for two epoxy system, 381
testing of adhesive bond between stiff epoxy and titanium disc, 380
shear (interference), 316
cross section of joint interface, 317
typical design, 317
textured surface, 316–17
viscoelasticity of polymers and adhesives, 382–5
stress-strain curve for polymeric adhesive, 383
thermo mechanical spectra of two crosslinked epoxy systems, 385
Young’s and elastic modulus, 384
joint testing, 294–5
Kapton film, 273
knee prosthesis, 439–43
longitudinal section across brazed joint, 442
semi-finished metal-ceramic knee prostheses, 443
transverse section across brazed joint, 441
Knudsen number, 241
lap joint, 271
laser conduction welding, 214–22
focused laser beam impinges on a metallic surface, 215
laser energy, 225
absorption, 215–18
absorptivity of laser beam at room and melting temperature, 217
laser welds by conduction and keyhole welding, 216
focused laser beams, 222–5
future trends, 233–5
hermetic-sealing technique, 212–14
hermetically welded pacemaker, 214
implantable medical devices, 211–35
laser conduction welding, 214–22
parameters, 225–8
laser pulse, 226
overlap of pulse laser seam weld, 227
seam weld joint cross-section, 227
requirements, 228–33
Butt joint design, 231
temperature cycle, 232
laser melting, 218–22
semi-infinite substrate under laser irradiation, 219
times to melt and vaporise under Nd:YAG laser irradiation, 222
bonding mechanism, 170–2
crossed-wire NITi, 170
overwelded LMW Pt–10% Ir to 316 LVM SS crossed-wire joints, 173
effects on mechanical performance, 138–40
deformation, 141
multiple plateaus in processed samples, 140
tensile curves for varying peak power input, 139
effects on NiTi microstructure and phase transformation, 140–4
base and re-solidified material cross section, 142
DSC scans for base and CO2 laser-welded metal, 144
DSC scans for base and Nd:YAG laser–welded metal, 144
EDS line scan across weld region, 142
fusion zone microstructure at the top of weld–fusion zone, 143
fixtures for crossed-wire welding, 169
joint breaking force, 171
Pt-10% Ir to 316 LVM SS crossed-wire joints, 172
pulsed profile, 171
wire orientation, 172–4
cross-section of Pt–10% Ir to 316 LVM SS crossed-wire LMW joint, 173
laser–seam welding, 69–70
beam delivery, 353–5
clamping, 355–6
laser types, 350–3
carbon dioxide, 352
diode, 351
fibre, 351–2
2.0μm wavelength lasers, 352–3
Nd:YAG, 351
welding plastics usage, 351
process configurations, 278
schematic diagram, 34
leak path, 240–44
air conductance vs. tube diameter, 244
dimensionless Reynolds and Knudsen number, 241
determination based on helium content, 252–7
flow rate detection, 257
package volumes and specification, 252
variable definitions, 253
measurement, 249–52
weight loss, 250–1
physics, 237–49
commonly used desiccants and getters for internal moisture controls, 239
electronic enclosures joint designs, 244–9
internal moisture content vs. dew point temperature, 238
suppression capability of various gases, 239
Lewis acid, 6
Lewis base, 6
interaction, 8
light curable adhesives, 401
linear continuous conveyer automatic machine, 331–2
Keifel high throughput linear continuous automatic RF welding system, 334
linear viscoelasticity (LVE), 383
liquid-phase indirect bonding techniques, 421
Maxwell-Wagner polarisation, 324
mean-free path, 241–2
mechanical forces, 388–9
mechanical interlock, 454–5
conical female cavity (bore), 417
conical male cone (trunnion), 416
adhesive types, 397–401
epoxy dispense pattern on pacemaker titanium shield, 399
RTV silicone dispensed onto device to prevent fluid ingress, 398
corrosion performance evaluation of metal welds, 178–207
current direct measurements, 187–96
data gathering, 196–8
data interpretation, 204–5
future trends, 206–7
instrumentation and equipment, 201–2
measurements, 183–7
mitigations, 205–6
overview, 178–83
test sample preparation, 198–201
microwelding, 47–76
future trends, 76–7
joint design and process selection, 65–73
materials challenges, 49–56
testing and verification, 73–6
anatomy of interaction, 10–20
interface between an artificial implant and biological tissue, 19
living cells, 16–18
protein dissolved in biofluid, 16
protein molecule, 13–16
tissues, 18–19
tribology, 19–20
variation of interfacial free energy with separation, 12
biological interactions, 3–24
drug delivery materials, 20–1
future trends, 24
hierarchy of interactions determining biocompatibility, 23
metrology of biocompatibility, 21–3
overview, 3–10
concept system, 4
definition, 4–5
importance of materials used in implanted device, 5
interaction changed due to welding and joining, 10
nature of interaction, 5–7
ontology, 4
surface attributes, 5
surface free energy, 7–10
sterilisation, 79–128
effects on different materials, 96–121
methods, 80–96
overview, 79–80
suitable method selection, 126–7
fundamental processes, 263–7
diffusion process, 266
key parameters, 266–7
modulus vs temperature for amorphous and semicrystalline polymers, 265
squeeze flow model at joint interface, Plate II
thermoplastics vs thermosets, 264
welding of plastics based on heating techniques, 265
radio frequency (RF) and dielectric welding, 323–43
dielectric heating fundamentals, 324–7
key factors affecting sealing process and seal quality, 333–8
RF welding process advantage limitations and future trends, 341–3
sealing process description and process parameters, 327–33
testing approaches for seals and dielectric sealing process, 338–41
weldability, 338
transmission laser welding strategies, 344–68
advantages and limitation, 344–5
applications, 360
equipment forms, 350–6
joint designs, 359
main welding parameters and effects, 349–50
monitoring and quality control, 360
process description, 345–9
weldable materials, 356–9
ultrasonic welding, 296–322
advantages and limitations, 321–2
fundamental processes, 297–302
horn design, 309–12
other specific applications, 318–20
parameters and control, 302–5
part and joint design, 313–17
process optimisation, 317–18
troubleshooting, 320–1
weldability, 306–9
weldability, 267–9
alloys and copolymers, 267–8
moisture, 269
plastics with filters or regrind, 268
special additives and colourants, 269
table for thermoplastics, 268
testing, 269
welding methods, 261–95
external heating processes, 271–9
implant welding processes, 283–7
internal heating processes, 279–83
part and joint design, 269–71
potential impacts from other manufacturing processes, 286–7
special welding applications, 287–95
bonding strategies and adhesives, 370–402
adhesion mechanism, 388–94
adhesion promotion, 395–7
adhesive types used in medical devices, 397–401
joint design with adhesive, 371–88
melt depth, 220
melting time, 221
biomaterials, 407–46
active brazing, 423–43
direct and indirect bonded, 418–23
mechanical, 415–17
challenges, 409–15
ceramic cup and femoral ball, 412
friction and wear of Al2O3-Al2O3 hip joint vs metal polyethylene prosthesis, 411
mechanical properties of most popular orthopaedic biomaterials, 410
most common orthopaedic biomaterials with their primary uses, 409
properties of bioceramics vs some metals, 414
relative rates of bioreactivity for ceramic implants materials, 411
time dependence of formation of bone bonding, 412
future trends, 443–5
schematic illustration of FGM joint between a metal and ceramic, 444
metal to glass sealing, 212
sterilisation effects, 118–21
12-methacryloyloxydodecyl-pyridinium bromide (MDPB), 496
methyl methacrylate monomer, 500
micro-plasma welding, 212
micro-resistance spot welding (MRSW), 147–51
micro-tensile bond strength, 523–5
various design, 525
micro-TIG, 212
microwave-implant welding, 285–6
schematic diagram, 286
joint design and process selection, 65–73
materials challenges, 49–56
base metal and laser welds fracture surfaces, 55
base metal and laser welds made with oxygen content in argon shielding gas, 54
implantable materials, 49
laser weld between Ti and Pt alloys, 56
metallic material properties, 52–3
weldability matrix for metals, 51
weldability matrix for plastics, 50
medical components and devices, 47–76
shape–memory alloys, 133–52
testing and verification, 73–6
test and loading condition effect on measured weld strength, 75
2.0μm wavelength lasers, 352–3
bond strength of dental biomaterials, 514–30
behavioural adhesive tests, 520–5
bond strength testing rationale, 516–18
dental adhesive testing techniques classification, 518–20
future trends, 529–30
product life cycle in definitions of evidence-based medicine, 515
product life cycle of dental material, 515
structural adhesive tests, 525–9
modulus, 458
moisture, 269
monocalcium phosphate (MCP), 501
Morse taper coupling, 415–16
Mynx vascular closure system (VCS), 471–2
arteriotomy, 472
nanoleakage, 492
neodymium yttrium aluminium garnet See Nd:YAG lasers
neurostimulators, 59–64
spinal nerve stimulation implant, Plate I
Nitinol (NiTi), 364
fundamentals, 134–8
phase diagram, 135
microwelding, 138–51
nitrile, 117
non-planar complex die design, 334–5
non-uniform corrosion, 179
Ocular Therapeutix See ReSure Ocular Bandage
OcuSeal Liquid Ocular Bandage, 469
OcuSeal applicator after assembly and ready to apply, 470
olefin polymers, 113–14
optical waveguide lightmode interferometry (OWLI), 22
optical waveguide lightmode spectroscopy (OWLS), 22
orbital-vibration welding, 281
osteomyelitis, 498
overlap rate, 226
ozone, 94–6
commercial ozone steriliser, 95
effects on polymers, 110–13
schematic diagram, 94
pacemakers, 59–64
manufacturing microjoining processes, 60
typical implanted cardiac leads, Plate I
part design, 313–14
near-field vs far-field, 313
parallel and uniform contact, 313
resonance effects, 314
thin-wall welding application, 312
stress risers, 313
PEEK-OPTIMA, 366
peel, 373
peel testing, 74
PEG, 458–63
crosslinking reaction of PEG SS end groups with primary amines, 462
four-armed PEG functionalised with N-hydroxy-succinimidylsuccinate, 460
four-armed PEG synthesis, 459
schematic of hydrogel structure, 462
percutaneous transluminal coronary angioplasty (PTCA), 289
periodontitis, 498
phenolics, 116
physical vapour deposition (PVD), 418
pin and strap technology, 376
pinhole, 229
schematic diagram, 230
plasma-seam welding, 69
plasma welding, 246
different sterilisation modalities effect, 113–18
ethylene oxide effects, 96–100
polymers compatible with the ethylene oxide technique, 97–9
heat sterilisation effect on polymers, 100–5
polymer compatibility for dry heat and steam sterilisation techniques, 102–5
polymers and materials compatible with dry-heat sterilisation technique, 106
compatibilities of some polymers with hydrogen peroxide, 107
irradiation effects on polymers, 108–10
compatibilities of some polymers for irradiation, 110
ozone sterilisation effects on polymers, 110–13
compatibility of some polymers for ozone sterilisation technique, 111–12
crossed-wire joint, 159–60
future trends, 174
joining processes, 162–73
joining to stainless steel wires for electronic medical devices, 154–74
material joining challenges, 156–9
intermetallic formation, 157–8
material properties effect on joint formation, 156
thermal effects on based materials, 156–7
welding effect on corrosion resistance, 158–9
material properties, 155–6
plunge welding, 305
point of greatest vulnerability (PGV), 204
polarisation test, 188
poly terephthalate copolymer, 116
polyacid-modified composite resins, 493–4
polyacrylic, 117
polyacrylic acid, 502
polyamides, 115
poly(anhydrides), 503–4
polyaryletherketone, 116
polycarbonate, 117
polychlorophrene, 118
polyester, 116
poly(ester) methacrylates, 504–5
cross-section of laser weld between carbon-black filled and natural parts, 367
cross-section of laser weld between two carbon-black filled parts, 367
transmission laser welding to carbon pigmented moulded material, 366
polyimide, 116
polyketones, 116
polymer bags, 73
polymer enclosures, 73
polymer tube-to-solid pin assembly, 72–3
polymer tube-to-tube assembly, 72
heat sterilisation effect, 100–5
irradiation effects, 108–10
ozone sterilisation effects, 110–13
poly(methyl) methacrylate bone cements, 500–1
poly(propylene fumarate) (PPF), 504
practical adhesion, 375
pressure, 295
pressure sensitive adhesives (PSA), 400
primary forces, 390
process control, 303
weld collapse distance, 303
weld energy, 303
weld time, 303
process optimisation, 317–18
ProGEL Surgical Sealant, 476
pseudoelasticity, 136–8
stress–strain curve for pseudoelastic NiTi alloy, 137
pull testing, 74
pulse repetition, 226
pulse width, 226
pumps, 58
automatic tote box irradiator, 89
irradiation, 89
fluoropolymers, 288
through-transmission IR principle with black PFA at joint interface, Plate IV
heating fundamentals, 324–7
heating mechanisms, 324–7
key factors affecting sealing process and seal quality, 333–8
die temperature, 330
hold time, 330
interdependency of process parameters, 329
power input, 329
power requirement, 328–9
single vs double cycle process, simultaneous vs sequential, 330
weld pressure/collapse distance, 329
weld/seal time, 329
radio frequency (RF) welding of medical plastics, 323–43
testing approaches for seals and dielectric sealing process, 338–41
weldability, 338
RF welding process advantage limitations and future trends, 341–3
future trend, 342–3
RF sealing vs conventional heat sealing, 342
sealing process description and process parameters, 327–33
key process requirements and parameters, 328–31
sealing-process automation, 331–3
radioactive seed implants, 64
radioactive tracer gas, 251
random sequential addition (RSA), 13
regrind plastics, 309
residual gas analysis (RGA), 233
resin adhesives, 494–5
resin modified glass ionomers (RMGICs), 494
bonding mechanism, 167–8
crossed-wire RMW process, 163
joint breaking force for single pulse RMW, 166
mechanical properties and failure mechanism, 145–7
effects of welding current on joint breaking force and set-down, 145
failure modes with increasing weld current, 147
fracture surfaces of joint welded at different welding currents, 146
micro-resistance spot welding (MRSW) on NiTi microstructure and phase transformation, 147–51
DSC heating and cooling curves of annealed wire, 151
hardness traces along cross-section of welds, 149
joints welded at different welding currents, 148
stages of the bonding mechanism, 150
RMW crossed-wire joints, 165
setdown in crossed-wire joining, 164
resistance-seam welding, 69
resistive-implant welding, 285
schematic diagram, 285
ReSure Ocular Bandage, 469–71
covering a corneal incision one day after cataract surgery, 470
Reynolds number, 241
ring-to-ring assembly, 71–2
roll-processing method, 347
room temperature vulcanised (RTV), 398–9
rotary table process, 305
saturated steam, 90
schematic diagram, 320
scanning ion conduction microscopy (SICM), 23
sealants, 454
tissue adhesives for surgical applications, 449–80
application methods, 456–7
bonding mechanism, 454–6
commercial biostable bio-derived sealants and adhesives, 477–9
commercial biostable synthetic sealants and adhesives, 479–80
commercial resorbable bio-derived sealants and adhesives, 475–7
commercial resorbable synthetic sealants and adhesives, 464–74
definitions and general considerations, 454
principles, 450–3
synthetic bioresorbable sealants, 457–64
sealed bags, 365
semi-automatic manual loading machine, 331
RF machine, 332
sensors, 58
Septacin, 504
micro-welding, 133–52
future trends, 151–2
laser welded microisotopes made from Nitinol, 134
shape-memory effect (SME), 136
shear bond strength test, 521–3
FEM of stress distribution, 522
interfacial stress distribution of vertical stresses, 522
shear loading, 372–3
silica fillers, 496
silicone adhesives, 398
silicone medical adhesive, 376
Silly Putty, 382
siloxane, 394
longitudinal seam weld, Plate VIII
solid-phase diffusion welding, 418
solid-phase indirect bonding techniques, 421
solid state bonding process, 418–19
solvent bonding/welding, 291–4
compatible polymers with solvents for bonding, 293
solvent selection for bonding amorphous polymers, 292
solvent welding, 399–400
spin welding, 280
spot welding, 319
stacking, 318
schematic diagram, 319
crossed-wire joint, 159–60
future trends, 174
joining processes, 162–73
joining to platinum alloy wires for electronic medical devices, 154–74
material joining challenges, 156–9
intermetallic formation, 157–8
material properties effect on joint formation, 156
thermal effects on based materials, 156–7
welding effect on corrosion resistance, 158–9
material properties, 155–6
steam autoclave, 92–3
dynamic evacuation pulsing steam sterilisation cycle, 92
dynamic gravity pulsing sterilisation cycle curve, 92
schematic diagram, 91
steam–air mixtures (SAM), 92
steam–formaldehyde, 93
step joint, 271
effects on different materials, 96–121
different modalities effect on plastics, 113–18
metals, 118–21
plastics, 96–113
effects on medical materials and welded devices, 79–128
effects on welded joints, 121–5
miscellaneous effects, 125
methods, 80–96
overview, 79–80
suitable method selection, 126–7
sterility assurance level (SAL), 127
strength, 458
stress-induced martensite (SIM), 137–8
stress–strain curve, 136–8
pseudoelastic NiTi alloy, 137
structural integrity tests, 519–20
adhesive, 525–9
alternative design for cantilever resin-bonded bridge, 529
cantilever resin–bonded bridges, 526–9
effect of elastic modulus on maximum stress, 527
FEA model of local stress distribution, 527
simple peel test for a cantilever bridge, 526
tensile peel strength and fracture toughness, 528
factors influencing performance of dental materials, 520
stud welding, 319
Stumbo method, 82
styrene polymers, 114
substrate, 454
SuperGlue, 400
surface energy, 390–3
surface free energy, 7–10
medical materials that interact repulsively and attractively with the host, 10
surface tension parameters of some artificial and biological materials, 9
surface roughening, 395
principles of tissue adhesives and sealants, 450–3
placement over incision to provide apposition, 451
polymerisation of cyanoacrylate, 453
resorbable tissue adhesive maybe placement, 451
tissue adhesives and sealants, 449–80
application methods, 456–7
bonding mechanism, 454–6
commercial biostable bio-derived sealants and adhesives, 477–9
commercial biostable synthetic sealants and adhesives, 479–80
commercial resorbable bio-derived sealants and adhesives, 475–7
commercial resorbable synthetic sealants and adhesives, 464–74
definitions and general considerations, 454
synthetic bioresorbable sealants, 457–64
swaging, 320
swelling, 458
chemical structure of focalSeal L macromonomer, 461
light activated polymerisation of FocalSeal L lung sealant, 461
synthetic hydrogel sealants bioresorption, 463–4
hydrogel sealants swell, soften and weaken after implantation, 464
hydrolysis reaction of PEG succinate linkages, 463
resorption of FocalSeal S rat subcutaneous implants, 465
Tafel extrapolation method, 189–90
tear seal die design, 335–6
bottom flat seal and die seal and attached to aluminium base plate, 336
set of dies with flat and tear seal, 336
Teflon, 288
temperature-induced transformation, 135–6
shape-memory effect (SME) behaviour of Nitinol SMA, 137
volume transformed as a function of temperature, 136
tensile loading, 372
tetracalcium phosphate (TTCP), 501
tetracylcine, 502
textiles, 358–9
protective clothing with seams welded and hence sealed using laser welding, 358
thermal modelling, 347–8
finite element thermal model, Plate VII
thermoplastics, 263
thermosets, 263
three dimensional complex die design, 334–5
through-transmission infrared welding, 72
time of flight secondary ion mass spectrometry (ToF SIMS), 393
bonding mechanism, 454–6
stained tissue section showing FocalSeal S sealant, 456
tissue surface, 455
sealants for surgical applications, 449–80
application methods, 456–7
commercial biostable bio-derived sealants and adhesives, 477–9
commercial biostable synthetic sealants and adhesives, 479–80
commercial resorbable bio-derived sealants and adhesives, 475–7
commercial resorbable synthetic sealants and adhesives, 464–74
definitions and general considerations, 454
principles, 450–3
synthetic bioresorbable sealants, 457–64
TissuePatch, 474
tongue and groove joint, 271
antibacterial adhesives, 491–8
experimental dental materials, 495–8
materials used for repair, 492–5
total joint arthroplasty (TJA), 409
catheters and small-diameter tubing, 362
polyetheretherketone (PEEK) film and implants, 365–8
sealed bags and inflatable devices, 365
textiles and vascular graft, 362–5
medical plastics, 344–68
equipment forms, 350–6
joint designs, 359
main welding parameters and effects, 349–50
monitoring and quality control, 360
summary of features of optical monitoring methods, 361
process description, 345–9
advantages and disadvantages, 346
beam manipulation with scanning optics, 348
colour independence, 348–9
diagram showing beam movement over work piece, 347
laser-welded transparent medical devices, 349
modelling, 347–8
weldable materials, 356–9
compatible combinations, 357
textiles, 358–9
transmission properties, 356–7
weld compatibility between different plastics, 357
weldable plastics, 356
transmission properties, 356–7
Transverse Electromagnetic Mode (TEM), 223
travel speed, 226
trigger force, 304
trunnion See conical male cone
tube-to-tube assembly, 71–2
tubing, small-diameter, 362
turntables indexing, 331
RF welding systems, 333
ultrasonic bonding, 124
fundamental processes, 297–302
boosters and horns for 40kHz ultrasonic machine, 299
components of an ultrasonic-welding machine, 298
converter booster and horn assembly for 20kHz ultrasonic machine, 299
heating and welding with energy director at joint interface, 301
main components, 297
storage vs loss modulus, 301
typical bench-top ultrasonic-welding equipment from various venders, 298
welding machine characteristics based on operation frequencies, 300
medical plastics, 296–322
advantages and limitations, 321–2
horn design, 309–12
part and joint design, 313–17
process optimisation, 317–18
weldability, 306–9
other specific applications, 318–20
degating, 320
insertion, 318–19
sewing, slitting, sealing scan welding, 320
spot welding, 319
stacking, 318
stud welding, 319
swaging, 320
parameters and control, 302–5
other process parameters, 303–4
plunge or continuous welding, 305
power requirement, 302
process control, 303
rotary table or continuous-conveyer process, 305
welding process operation, 305
schematic diagram, 39
troubleshooting, 320–1
alignment, 321
material issues, 321
part and joint design, 321
part-dimension consistency, 321
process parameters, 321
uniform corrosion, 179
uniformity, 336–7
vaporising time, 221
vascular devices, 57–8
balloon catheter joined to lumen expanding a laser cut stent, 58
guidewire for catheter applications, 57
laser cut stent, 59
vascular graft textile, 362–5
cross-sectional view of laser weld between polyester fabric and polyester film, 364
schematic illustration of abdominal aortic aneurysm along with Anaconda endovascular device, 363
vibration amplitude, 303–4
vibration welding, 280–1
orbital-vibration, 282
schematic diagram, 281
Vicryl, 453
vinyl polymers, 115
void in weld, 229–30
schematic diagram, 229
von Kossa staining method, 433
weak boundary layers, 394
Wein’s law, 275
weld discolouration, 230–1
weld force, 304
weld pressure, 304
material structure and properties, 306–9
additives, 307
amorphous vs semicrystalline, 306–7
colourants, 307
filler materials, 308
grade/alloy/blend, 309
moisture, 308–9
regrind, 309
PVC RF sealing seal cross-section with weld bead, 340
RF welding weldability for different plastics, 339–40
WeldControl system, 367–8
sterilisation, 79–128
effects on welded joints, 121–5
methods, 80–96
overview, 79–80
suitable method selection, 126–7
adhesive bonding, 262
fundamental processes of plastics welding, 263–7
based on heating techniques, 265
diffusion processes (chain entanglement), 266
key parameters, 266–7
modulus vs temperature for amorphous and semicrystalline polymers, 265
thermoplastics vs thermosets, 264
mechanical fastening, 262
medical plastics, 261–95
external heating processes, 271–9
implant welding processes, 283–7
internal heating processes, 279–83
potential impacts from other manufacturing processes, 286–7
weldability, 267–9
part and joint design, 269–71
typical joint design, 271
process operation, 305
special welding applications, 287–95
wettability, 390–3
wire-to-pin assemblies, 66–8
laser welding of small diameter coil, 68
resistance spot weld of titanium wire to Ti6Al4V terminal block, 67
wire-to-wire assembly, 65–6
tip forming of a catheter wire, 66
work of adhesion, 375
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