Basic Properties
Bioperformance of Shape-Memory Alloys
L'Hocine Yahia, Jorma Ryhänen
1 Introduction ................................................. 3
2 Medical Applications ......................................... 4
2.1 Orthopedic Surgery ...................................... 5
2.2 Cardiovascular Surgery .................................. 5
2.3 Gastroenterologic Surgery ............................... 6
2.4 Urologie Surgery ........................................ 6
2.5 Other Medical Devices ................................... 7
2.6 FDA Status of NiTi Medical Devices ...................... 7
3 Biocompatibility of NiTi Alloys .............................. 8
3.1 Nickel Issue ............................................ 8
3.2 In Vitro Biocompatibility (Cell Cultures) .............. 10
3.3 In Vivo Biocompatibility of NiTi (Animal Models) ....... 12
3.4 Clinical Studies of NiTi Orthopedic Devices ............ 17
References .................................................. 19
Processing and Quality Control of Binary NiTi Shape-Memory
Alloys
Matthias Mertmann
1 Introduction ................................................ 24
2 Production and Processing of NiTiNOL ........................ 26
3 Thermomechanical Treatment and Functional Properties ........ 27
4 Quality Control of NiTiNOL Semi-Finished Shapes ............. 29
4.1 Definition of Terms .................................... 30
4.2 Measurement of Relevant Functional Properties .......... 31
5 Conclusions ................................................. 34
References ..................................................... 34
Corrosion Resistance and Biocompatibility of Passivated NiTi
Christine Trepanier, Ramakrishna Venugopalan, Alan R. Pelton
1 Introduction ................................................ 35
2 Active Corrosion Testing .................................... 36
3 Passive Corrosion Behavior .................................. 40
4 Effect of Surface Layer on Corrosion Resistance ............. 41
5 Nickel Release and Biocompatibility ......................... 42
6 Conclusions ................................................. 44
References ..................................................... 44
The High Damping Capacity of Shape-Memory Alloys
J. Van Humbeeck, Y. Liu
1 Introduction ................................................ 46
2 Internal Friction Behaviour of Shape-Memory Alloys .......... 47
2.1 Internal Friction during Martensitic Transformation .... 47
2.2 Internal Friction in the Martensitic Phase ............. 48
2.3 Specific Results on Ni-Ti Shape-Memory Alloys .......... 52
2.4 Energy Loss during Pseudoelastic Loading ............... 56
2.5 Some Remarks on the Fatigue Life of SMA Devices ........ 57
3 Conclusions ................................................. 58
References ..................................................... 58
Physical and Biochemical Principles of the Application of
TiNi-Based Alloys as Shape-Memory Implants
L.L. Meisner, V.P. Sivokha
1 Introduction ................................................ 61
2 Shape-Memory Effect and Pseudoelasticity in TiNi-Based
Alloys ...................................................... 62
2.1 Role of the Chemical Composition ....................... 62
2.2 Role of the Phase Composition and the Thermo-
mechanical Treatment ................................... 64
2.3 Pseudoelastic Behavior of TiNi-Based Alloys ............ 66
3 Corrosion Properties and Electrochemical Behavior of TiNi-
Based Alloys ................................................ 70
References ..................................................... 71
Porous NiTi as a Material for Bone Engineering
Reed A. Ayers, Ted A. Bateman, Steven J. Simske
1 Introduction ................................................ 73
2 Porous Biomateriale in Craniomaxillofacial Applications ..... 74
3 NiTi Biocompatibility ....................................... 76
Mechanisms of NiTi Biocompatibility ......................... 76
4 Authors'Experience with NiTi ................................ 78
5 NiTi Versus Other Biomateriale .............................. 80
5.1 Mechanical Considerations .............................. 80
5.2 Formation Considerations ............................... 81
5.3 Machining .............................................. 81
5.4 Biocompatibility ....................................... 82
6 Present and Future Advantages of Porous NiTi ................ 82
7 Future Work ................................................. 83
8 Conclusions ................................................. 85
References ..................................................... 86
Ti-Ni-Mo Shape-Memory Alloys for Medical Applications
Tae-Hyun Nam
1 Introduction ................................................ 89
2 Phase Transformation Behaviors of Ti-Ni-Mo Alloys ........... 90
3 Deformation Characteristics of Ti-Ni-Mo Alloys .............. 94
4 Shape-Memory Characteristics of Ti-Ni-Mo Alloys ............ 101
5 Summary .................................................... 102
References .................................................... 102
Orthopaedic Applications
Ti-Ni-Mo Shape-Memory Alloys for Medical Applications
Kerong Dai
1 Introduction ............................................... 105
2 The Basic Principles and Requirements ...................... 105
2.1 Biocompatibility and Mechanical Properties ............ 105
2.2 Transformation and Recovery Temperatures .............. 106
2.3 The Recovery Force .................................... 106
3 Shape-Memory Implants in the Treatment of Transarticular
Fracture ................................................... 108
3.1 Compression Staples ................................... 108
3.2 Patellar Fixator ...................................... 111
3.3 The Shape-Memory Screw ................................ 111
4 Shape-Memory Implants in the Treatment of Long-Bone Shaft
Fractures .................................................. 113
4.1 Shape-Memory Sawtooth-Arm Embracing Internal Fixator .. 113
4.2 Fork-Like Shape-Memory Intramedullar Nail and
Bow-Shaped Compressive Osteo-Connector ................ 117
5 Hand Surgery ............................................... 117
5.1 Shape-Memory Compression Plate ........................ 119
5.2 Clamping Plate ........................................ 119
6 Spinal Surgery ............................................. 120
6.1 Ω-Shaped Intravertebral Artificial Joint .............. 120
6.2 Shape-Memory Expansion Clamp .......................... 120
6.3 Shape-Memory Device Used in Scoliosis ................. 121
7 Arthroplasty ............................................... 121
7.1 Shape-Memory Double-Cup Prosthesis of Hip ............. 121
7.2 Other Applications .................................... 125
8 Future Studies ............................................. 125
References .................................................... 127
The Surgical Correction of Scoliosis with Shape-Memory Metal
Dirk Jan Wever, Albert G. Veldhuizen
1 Introduction ............................................... 129
1.1 Scoliosis ............................................. 129
1.2 The Current Surgical Treatment of Scoliosis ........... 129
2 Biomechanical Aspects of the Correction of Scoliosis with
Shape-Memory Metal ......................................... 132
2.1 The Force System in the Scoliotic Spine ............... 132
2.2 Force-Controlled Correction of Scoliosis with Shape-
Memory Metal .......................................... 133
3 Biocompatibility Aspects of the Shape-Memory Metal
Scoliosis-Correction Device ................................ 135
3.1 The in Vitro Biocompatibility of Shape-Memory Metal ... 135
3.2 Animal Experience with Shape-Memory Metal Scoliosis
Correction Device ..................................... 140
4 Conclusions ................................................ 143
References .................................................... 144
Shape-Memory Implants in Spinal Surgery: Long-Term Results
(Experimental and Clinical Studies)
Boris M. Silberstein, Victor Gunter
1 TiNi Device for the Anterior Fusion of the Spine ........... 147
1.1 Introduction .......................................... 147
1.2 Material, Method and Experimental Results ............. 147
1.3 Clinical Results ...................................... 148
1.4 Complications ......................................... 149
1.5 Discussion ............................................ 149
1.6 Conclusion ............................................ 149
2 Porous TiNi Implants ....................................... 150
2.1 Introduction .......................................... 150
2.2 Material, Method and Experimental Results ............. 150
2.3 Clinical Results ...................................... 151
2.4 Conclusions ........................................... 151
References .................................................... 152
The Use of a Memory-Shape Staple in Cervical Anterior Fusion
(about 100 Human Implantations)
Olivier Ricart
1 Introduction ............................................... 153
2 Nitinol: Properties, Biocompatibility ...................... 153
3 Device Description ......................................... 154
4 Surgical Technique ......................................... 154
5 Material and Methods ....................................... 155
6 Results .................................................... 155
7 Other Complications ........................................ 157
8 Discussion ................................................. 158
9 Conclusions ................................................ 159
References .................................................... 160
The Double Compressive Nickel-Titanium Shape-Memory Staple
in Foot Surgery
Louis Samuel Barouk
1 Introduction ............................................... 162
2 The Doubly Compressive Nickel-Titanium Shape-Memory
Staple ..................................................... 162
2.1 Description ........................................... 162
2.2 Working Principles .................................... 163
3 Material and Methods ....................................... 165
4 Contraindications .......................................... 165
5 Clinical Results ........................................... 165
5.1 Shaft Osteotomy of the Great Toe First Phalanx ........ 165
5.2 Arthrodesis of the First Metatarso-Phalangeal Joint ... 170
5.3 Arthrodesis of the Lisfranc Joints, Osteosynthesis
or Arthrodesis of the Hindfoot ........................ 171
6 Conclusions ................................................ 173
References .................................................... 173
Orthodontic Applications
Corrosion Behavior of Ni-Ti Alloys in a Physiological Saline
Solution
Kazuhiko Endo, Hiroki Ohno
1 Introduction ............................................... 177
2 Anodic Corrosion Behavior of the NiTi Alloy and Other
Implant Alloys ............................................. 177
3 Dissolution of Ni Ions from the NiTi Alloy ................. 179
4 Characterization of the Surface Oxide Film on a Ni-Ti
Alloy ...................................................... 179
5 Surface Structure and Corrosion Characteristics of the
NiTi Alloy ................................................. 181
6 Factors Affecting the Corrosion Behavior of the NiTi
Alloys ..................................................... 181
6.1 Effects of Alloying ................................... 181
6.2 Effects of Surface Texture ............................ 184
6.3 Effect of Contact between Dissimilar Metals ........... 185
6.4 Effect of Amino Acids and Serum Proteins .............. 187
7 Surface Treatments for Improving the Corrosion Resistance
of the NiTi Alloy .......................................... 188
8 Summary .................................................... 192
References .................................................... 193
NiTi Alloys in Orthodontics
Andrea Wichelhaus
1 Introduction ............................................... 194
2 Conventional Wires and their Problems ...................... 194
2.1 The High-Elasticity Module ............................ 194
2.2 The High Load/Deflection Rate ......................... 194
3 NiTi Wires ................................................. 196
4 Thermal NiTi Wires ......................................... 198
5 Clinical Application of Thermal NiTi Wires ................. 200
6 Properties of NiTi Alloys in Orthodontics .................. 201
6.1 The Great Ability to Deflect (Shape Memory) ........... 202
6.2 Small Load/Deflection Ratio ........................... 202
6.3 Superelasticity ....................................... 202
6.4 Memory ................................................ 202
7 Advantages of NiTi Wires in Orthodontics ................... 202
8 Temperature Treatment of Orthodontic NiTi Wires ............ 203
9 Memory Maker ............................................... 203
10 Heat-Treated Archwires and Clinical Application ............ 205
11 NiTi-Stainless Steel Combinations .......................... 207
References .................................................... 208
Clinical Application of Shape-Memory Alloys in Orthodontics
Dietmar Siegner, Dagmar Ibe
1 Introduction ............................................... 210
2 History .................................................... 210
3 Basic Application Principles ............................... 211
4 When are Orthodontic Wires Superelastic? ................... 216
5 Limiting the Force ......................................... 217
6 Different Force Requirements for Different Teeth ........... 220
7 Other Superelastic Elements in Orthodontics ................ 224
8 Conclusions and Outlook .................................... 226
References .................................................... 228
Orthodontic application of NiTi Shape-Memory Alloy in China
Chu Youyi, Zhu Ming, Yang Fengzhi
1 Introduction ............................................... 229
2 Superelastic Archwire (SE Type) ............................ 229
3 Memory Archwire (RTF Type) ................................. 231
4 Rocking-Chair Archwire ..................................... 232
5 Superelastic Orthodontic Springs ........................... 233
References .................................................... 235
Progressive Damage Assessment of TiNi Endodontic Files
Yoshiki Oshida, Farrokh Farzin-Nia
1 Introduction ............................................... 236
2 Materials and Methods ...................................... 241
3 Results and Discussion ..................................... 243
4 Conclusions ................................................ 247
References .................................................... 248
Endovascular Applications
Effects of Surface Modification Induced by Sterilization
Processes on theThrombogenicity of Nickel-Titanium Stents
B. Thierry, M. Tabrizian, Y. Merhi, L. Bilodeau,
O. Savadogo, L'H. Yahia
1 Introduction ............................................... 253
2 Materials .................................................. 254
3 Methods .................................................... 255
3.1 Animal Preparation .................................... 255
3.2 Isolation and Labeling ................................ 256
3.3 Stent Insertion ....................................... 256
3.4 Extracorporeal AV Shunt ............................... 256
3.5 Auger-Electron Spectroscopy ........................... 257
3.6 Scanning Electron Microscopy .......................... 257
4 Results .................................................... 258
4.1 Surface Analyses of Electropolished NiTi Stents ....... 258
4.2 Effect of Sterilization on Thrombogenicity of
Electropolished NiTi Stents ........................... 259
4.3 Effect of Blood Flow on Platelet Adhesion of
Electropolished NiTi Stents in Comparison to
Stainless Steel ....................................... 259
4.4 Morphological Analyses of the Stents Post-Perfusion ... 262
5 Discussion ................................................. 262
6 Conclusions ................................................ 264
References .................................................... 264
X-Ray Endostenting Surgery of Vessels and Hollow Organs
I.Y. Khmelevskaya, I.K. Rabkin, E.R Ryklina, S.D. Prokoshkin
1 X-Rаy Endovascular Stent Surgery ........................... 267
2 Stenting Surgery on Bile Ducts ............................. 274
3 Stenting Surgery on Oesophagus ............................. 276
4 The Endostenting Surgery on Trachea by NiTi Spiral ......... 278
5 The Stenting Surgery on Cervical Canal of Uterus ........... 279
References .................................................... 281
Device for Extravasal Correction of the Function of Vein
Valves Based on Nitinol Shape Memory and Its Clinical
Application
S.D. Prokoshkin, A.P. Chadaev, E.P. Ryklina,
I.Y. Khmelevskaya, A.C. Butckevich
1 Introduction ............................................... 283
2 Anatomic Examination of Main Vein Valves and Grounds for
Corrector Shape Selection .................................. 285
2.1 Methods of Anatomic Examination ....................... 286
2.2 Results of Anatomic Examinations and Discussion ....... 287
3 Shape-Memory Nitinol Extravasal Correctors ................. 292
4 Clinical Approving and Effectivity of the Nitinol Shape-
Memory Extravasal Correctors ............................... 295
References .................................................... 299
Large-Caliber NiTi SMA Stents and Stent Grafts
John D. Pazienza, Willard Hennemann
1 Introduction ............................................... 301
2 Design Constraints ......................................... 302
3 Review of NiTi SMA Stent Designs ........................... 303
4 Test Requirements .......................................... 306
5 Clinical Applications ...................................... 310
6 Future Development ......................................... 312
References .................................................... 312
Shape-Memory Alloy for Interventional Stenting in View of
Its Development in China
Mi Xujun, Zhu Ming, Guo Jinfang, Yuan Guansen
1 Introduction ............................................... 315
2 Structural and Material Considerations for the Stent
Design ..................................................... 315
3 SMA Stent and Its Application in China ..................... 317
3.1 Nonvascular Applications .............................. 317
3.2 Vascular Applications ................................. 319
4 Discussion and Comments .................................... 320
4.1 Systematic Clinical Investigations .................... 321
4.2 Stent Manufacture ..................................... 321
4.3 Stent-Material Preparation ............................ 322
5 Summary ................................................... 323
References .................................................... 324
Other Medical Applications
An Implantable Drug Delivery System Based on Shape-Memory
Alloys
Dominiek Reynaerts, Jan Peirs, Hendrik Van Brussel
1 Introduction ............................................... 329
2 Design of a Delivery System for Solid Drugs ................ 330
2.1 Introduction .......................................... 330
2.2 Design of a Drug-Delivery Device for Solid Drugs ...... 330
2.3 Conclusion on Solid Drug Delivery ..................... 332
3 Design of a System for Delivery of Liquid Drugs ............ 332
3.1 Introduction .......................................... 332
3.2 Mechanical Design ..................................... 333
3.3 First Prototype Building .............................. 337
4 Operational Tests .......................................... 342
4.1 System Components ..................................... 342
4.2 Total System .......................................... 343
5 Possible Improvements ...................................... 343
6 Conclusion ................................................. 344
References .................................................... 345
Subject Index ................................................. 347
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