Design of Artificial Human Joints & Organs is intended to present the basics of the normal systems and how, due to aging, diseases or trauma, body parts may need to be replaced with manmade materials. The movement of the body generates forces in various work situations and also internally at various joints, muscles and ligaments. It is essential to figure out the forces, moments, pressure etc to design replacements that manage these stresses without breaking down. The mechanical characterization of the hard and the soft tissues are presented systematically using the principles of solid mechanics. The viscoelastic properties of the tissue will also discussed. This text covers the design science and methodology from concept to blueprint to the final component being replaced. Each chapter will be a brief overview of various joint/organ replacement systems.
Engineers working on artificial joints and organs, as well as students of Mechanical Engineering and Biomedical Engineering are the main intended audience, however, the pedagogy is simple enough for those who are learning the subject for the first time.

1 Overview of Human System and Its Artifi cial Replacement 1

1.1 Human Body’s Superfi cial Anatomy 1

1.2 Human Body Features 1

1.3 Body Size, Type, and Proportion 2

1.4 A Brief Outline of the Organization of the Human System 3

      1.4.1 Tissue + Tissue = Organ (Different Tissues Together Form an Organ) 3

      1.4.2 Organ + Organ = Organ System 4

1.5 Major Organ Systems 4

      1.5.1 Integumentary System 5

      1.5.2 Muscular System 5

      1.5.3 Skeletal System 5

      1.5.4 Cardiovascular System 7

      1.5.5 Respiratory System 7

      1.5.6 Urinary System 7

      1.5.7 Reproductive System 9

      1.5.8 Nervous System 11

      1.5.9 Digestive System 11

      1.5.10 Lymphatic System 12

      1.5.11 Immune System 12

1.6 Common Names of Internal Organs (in Alphabetical Order) 14

1.7 Brief Idea of Artifi cial Organs 14

      1.7.1 Different Types of Organs 15

      1.7.2 Brain 15

      1.7.3 Cardia 16

      1.7.4 Corpora Cavernosa 16

      1.7.5 Ear 16

      1.7.6 Eye 16

      1.7.7 Heart 17

      1.7.8 Limbs 17

      1.7.9 Liver 17

      1.7.10 Lungs 18

      1.7.11 Pancreas 18

      1.7.12 Bladder 18

      1.7.13 Ovaries 18

      1.7.14 Beyond Restoration 19

      1.7.15 Timeline of Successful Transplants 19

References 20

Exercises 20

2 Mechanical Properties of Biological Materials 23

2.1 Introduction 23

2.2 Structural Versus Material Properties 23

      2.2.1 Anisotropy and Nonhomogeneity 24

      2.2.2 Viscoelastic Properties 24

      2.2.3 Viscosity 25

2.3 Testing Procedures 25

2.4 Bones 26

      2.4.1 Composition 26

      2.4.2 Structure 27

2.5 Material Properties and Related Behavior 29

2.6 Cartilage 32

      2.6.1 Composition 32

2.7 Material Properties and Related Behavior 33

2.8 Ligaments 34

      2.8.1 Composition 34

2.9 Material Properties and Related Behavior 36

      2.9.1 Ligaments Have Characteristics of Strain-Rate Sensitivity, Stress-Relaxation, Creep, and Hysteresis 36

2.10 Correlation Between Structure and Function 37

      2.10.1 Ligament–Bone/Tendon–Bone Insertions 38

Reading List 39

Problems 39

3 Basics of Design Process 41

3.1 Introduction 41

3.2 Adoptive and Adaptive Design 41

      3.2.1 Introduction 41

3.3 Introduction to Machine Design 42

3.4 Principle of Science or Mechanism to Be Used 43

3.5 Safety of Products 47

3.6 Manufacturability 47

3.7 Standardization 48

3.8 Customization 48

For Further Details, the Following Books May Be Consulted 49

Exercises 49

4 Biomaterials and Its Characterization 51

4.1 Introduction 51

4.2 Biomineralization 52

4.3 Abalone Shell 54

4.4 Self-Assembly 55

4.5 Structural Hierarchy 56

4.6 Applications 56

4.7 Compatibility 57

For Further Reading, These Papers May Be Consulted 58

4.8 Biopolymers 59

      4.8.1 Applications 60

      4.8.2 Sources 60

      4.8.3 Applications 60

      4.8.4 Sources 60

      4.8.5 Applications 61

      4.8.6 Benefi ts 61

4.9 Polymers for Healthcare 62

      4.9.1 Sterilization 62

      4.9.2 Compatibility with Sterilization Method of Various Industrial Biopolymers (Solviva) 62

      4.9.3 Polyether Ether Ketone (PEEK) 63

      4.9.4 Applications 64

4.10 Bioceramics 64

      4.10.1 History 64

      4.10.2 Current Status 65

      4.10.3 Future Trends 65

4.11 Bioceramic Materials 65

      4.11.1 Bioinert 65

      4.11.2 Bioactive 66

4.12 Hydroxyapatite: Medical Uses 66

      4.13 Bioactive Glass 67

      4.13.1 Compositions 67

      4.13.2 Mechanism of Bioactivity 67

      4.13.3 Applications 68

For Further Study Consult the Reading List (Ceramics and Glass) 68

4.14 Metals as Biomaterials 69

4.15 Signs of Inferior Tissue Response 71

4.16 Stress-Shielding Phenomena 71

4.17 Shape-Memory Alloy 72

Problems 73

5 Dental Implants: Their Design and Manufacture 75

5.1 Introduction 75

      5.1.1 Success Criteria 75

5.2 Anatomy of Human Jawbones 77

5.3 Dental Implants 78

5.4 Components of Dental Implant 81

5.5 Types of Implants in Use 81

      5.5.1 Subperiosteal Implants 81

      5.5.2 Transosteal Implants 82

      5.5.3 Endosteal Implants 83

      5.5.4 Biocompatibility and Implant Design 84

5.6 Biting Force 86

5.7 Implant Shape 87

5.8 Surface Characteristics 87

5.9 Bone Factors 88

5.10 Loading Conditions 89

      5.10.1 Prosthetic Considerations 90

      5.10.2 The Type of Prosthetic Reconstruction 90

      5.10.3 The Occlusal Scheme 90

5.11 The Number, Distribution, Orientation, and Design of Implants 90

5.12 Placement of Implants into Extraction Sites 91

5.13 Clinical and Biomechanical Considerations for Fixed Tooth Replacement 92

      5.13.1 Bone Tissue Factors 92

      5.13.2 Soft Tissue Factors 92

      5.13.3 Number of Implants 93

      5.13.4 Crown-to-Root Ratio 93

      5.13.5 Implant Orientation 94

5.14 Advantages of Permanent Tooth Replacement 94

5.15 Manufacture of Implants and Property Enhancement 94

References 95

Problems 96

Glossary of Dental Terminology 96

6 The Design of a Bone Fracture-Fixation Device 101

6.1 Introduction 101

6.2 External Fixation 101

      6.2.1 The Ilizarov Apparatus 105

6.3 Internal Fracture Fixation 106

      6.3.1 Wires 106

      6.3.2 Braided Multifi lament Wire 106

      6.3.3 Pins 107

      6.3.4 Screws 107

      6.3.5 Plates 109

      6.3.6 Intramedullary Nails 111

      6.3.7 Use of Machine Elements in External Fixators 114

6.4 Other Considerations 114

6.5 Materials Involved in Bone–Plate Design 114

6.6 Composite Materials 115

6.7 Bioactive Fixation Using Bioactive Materials 117

6.8 Compositions 119

6.9 Strong Interfacial Bond with Bone 119

Suggested Study for Fracture Fixation 119

Problems 121

7 The Shoulder Joint and Its Artifi cial Replacement 123

7.1 Introduction to Joint Replacement 123

7.2 The Shoulder Joint and Its Artifi cial Replacement 124

      7.2.1 Introduction 124

      7.2.2 The Different Joints 125

      7.2.3 Musculature 126

      7.2.4 Ligaments 127

      7.2.5 Glenohumeral Joint 127

      7.2.6 Glenoid 128

      7.2.7 Humerus 128

      7.2.8 Kinematics of the Glenohumeral Joint 129

      7.2.9 Geometrical Center and Center of Rotation 130

7.3 Humeral Translation Relative to the Scapula 130

7.4 Degrees of Freedom (DOF) 131

7.5 Range of Motion 132

7.6 Total Shoulder Replacement (Glenohumeral Arthroplasty) 134

7.6.1 Reasons for Shoulder Arthroplasty 134

7.7 Types of Shoulder Prostheses 135

7.8 Fully Constrained Type 136

7.9 Nonconstrained Type 138

7.10 Fixation Procedures 143

7.11 Causes of Failure 144

      7.11.1 Loosening of the Component 145

      7.11.2 Anterior Instability 146

      7.11.3 Superior Instability 146

      7.11.4 Posterior Instability 146

      7.11.5 Inferior Instability 146

      7.11.6 Rotator Cuff Tears 146

      7.11.7 Intraoperative Fractures 147

      7.11.8 Infection 147

      7.11.9 Neural Injuries 147

References 147

Problems 148

8 The Elbow Joint and Its Artifi cial Replacement 149

8.1 Introduction 149

      8.1.1 Movements 149

8.2 Muscles, Arteries, and Nerves 151

8.3 Parts of the Joint 151

8.4 Ligaments 152

8.5 Synovial Membrane 152

8.6 Carrying Angle 153

8.7 Diseases of the Elbow 153

      8.7.1 Tendonitis 153

      8.7.2 Fractures 153

      8.7.3 Arthritis 153

8.8 Elbow Replacement 154

8.9 Elbow Replacement Surgery 156

8.10 Life Expectancy of Prosthetic Elbow Joint 156

References 157

Problems 157

9 The Wrist Joint and Its Artifi cial Replacement 159

9.1 Anatomy 159

9.2 Rheumatoid Arthritis of the Hand and Wrist 159

9.3 Treatment 161

      9.3.1 Forces Generated in the Wrist Joint 161

9.4 Implants: Components of a Wrist Arthroplasty 163

9.5 Surgery 164

9.6 Postsurgical Care 165

References 165

Problems 166

10 The Finger Joint and Its Artifi cial Replacement 167

10.1 Introduction 167

10.2 Diseases of the Finger Joint 168

      10.2.1 Symptoms 170

      10.2.2 Nonsurgical Treatment 171

10.3 Finger Joint Replacement 171

      10.3.1 Introduction 171

      Problems 174

      References 175

11 The Hip Joint and Its Artifi cial Replacement 177

11.1 Introduction 177

11.2 Anatomy of the Hip Region 177

      11.2.1 Articulation 177

      11.2.2 Femoral Neck Angle 178

      11.2.3 Capsule 180

      11.2.4 Ligaments 180

      11.2.5 Blood and Nerve Supply 181

      11.2.6 Muscles and Movements 181

11.3 Hip Joint Replacement 182

      11.3.1 History 184

11.4 Modern Developments 185

11.5 Costs 186

11.6 Aseptic Loosening of Hip Prosthesis 186

11.7 Techniques of Surgery 187

11.8 Alternatives to Hip Replacement 187

      11.8.1 Apollo Hip System: Simple, Straight-Stem Design for the Low-Demand Patient 188

      11.8.2 Dr. K. H. Sancheti’s Hip Prosthesis 190

11.9 Design Modifi cation Using Hollow Section 191

      11.9.1 Stress Shielding 191

      11.9.2 Hollow Design 192

References & Reading List 193

Problems 194

12 The Knee Joint and Its Artifi cial Replacement 195

12.1 Anatomy 195

      12.1.1 Cruciate Ligaments 195

      12.1.2 Anterior Cruciate Ligament 196

      12.1.3 Action of Muscles 197

      12.1.4 Knee Joint Stabilization 197

12.2 Knee Replacement, or Knee Arthroplasty 199

      12.2.1 Introduction 199

      12.3 History 200

      12.3.1 Technique 201

12.4 Variations in Design 202

      12.4.1 Partial Knee Replacement 202

      12.5 Risks and Complications 203

      12.5.1 Loss of Motion 204

      12.5.2 Instability 204

      12.5.3 Infection 204

12.6 Developmental Work on a Congruent Tibial Component 205

      12.6.1 This Design has Two Advantages 207

      12.6.2 Disadvantages 208

12.7 Indian Effort 208

References 209

Problems 210

13 The Ankle Joint and Its Artifi cial Replacement 211

13.1 Introduction 211

      13.1.1 Structure 211

13.2 Bones and Joints 211

13.3 Ligaments and Tendons 212

13.4 Muscles 213

13.5 Nerves 214

13.6 Blood Vessels 214

13.7 Artifi cial Replacement of the Ankle Joint 214

13.8 The Operative Procedure 215

13.9 Complications 216

      13.9.1 Infection 217

      13.9.2 Loosening 217

      13.9.3 Nerve Injury 217

Study List 217

Problems 217

14 The Eye and Its Artifi cial Replacement 219

14.1 Anatomy of the Eye 219

      14.1.1 Extraocular Muscles 221

14.2 Development of the Eye 222

      14.2.1 Disorders of the Eye 224

      14.2.2 Disorders of the Eye Muscles 224

      14.2.3 Disorders of the Cornea, Iris, and Lens 224

      14.2.4 Disorders of the Retina 224

      14.2.5 Visual Impairments 224

14.3 Contact Lens 225

      14.3.1 Corrective Contact Lenses 228

      14.3.2 Cosmetic Contact Lenses 228

      14.3.3 Therapeutic Contact Lenses 229

14.4 Classifi cation of Contact Lenses 229

      14.4.1 By Construction Material 229

      14.4.2 By Time of Wear 230

      14.4.3 By Frequency of Replacement 230

      14.4.4 By Design 230

      14.4.5 Implantation 231

14.5 Manufacturing of Contact Lenses 231

      14.5.1 Hydrogel Materials 232

      14.5.2 Contact Lens Prescriptions 232

14.6 Complications 232

      14.6.1 Eyelid 233

      14.6.2 Conjunctiva 233

      14.6.3 Cornea 233

14.7 Usage 233

      14.7.1 Care 234

14.8 Current Research 234

14.9 Intraocular Lens 235

      14.9.1 History 237

      14.9.2 Materials Used for Intraocular Lenses 237

      14.9.3 Intraocular Lenses for Correcting Refractive Errors 238

      14.9.4 Types of PIOLs 239

      14.9.5 Accommodating IOLs 239

      14.9.6 Criticisms 240

      14.9.7 Candidates 240

14.10 LASIK Eye Surgery 241

      14.10.1 What Is LASIK? 241

      14.10.2 The LASIK Procedure 241

      14.10.3 Phacoemulsifi cation 242

      14.10.4 Demographics 242

      14.10.5 Diagnosis/Preparation 244

      14.10.6 Aftercare 245

      14.10.7 Risks 245

      14.10.8 Alternatives 246

14.11 Bionic Eye 246

Related Literature for Study 246

Study List 247

15 The Lung and Its Transplantation and Artifi cial Replacement 251

15.1 Introduction 251

15.2 Respiratory Tract 251

      15.2.1 Structure 252

15.3 Path Traced by Inhaled Air 254

15.4 Gaseous Exchange 254

15.5 Common Lung Diseases 255

15.6 Lung Transplantation 256

15.7 Types of Lung Transplants 257

      15.7.1 Lobe 257

      15.7.2 Single-Lung Transplant 257

      15.7.3 Double-Lung Transplant 257

      15.7.4 Heart–Lung Transplant 257

15.8 Design of Artifi cial Lungs 258

15.9 Design Overview 258

For Detailed Study, Consult the Following Papers 260

Problems 260

16 Design of the Total Artifi cial Heart 261

16.1 Introduction 261

16.2 Artifi cial Heart 261

      16.2.1 CardioWest Temporary Total Artifi cial Heart 261

      16.2.2 AbioCor Replacement Heart 262

16.3 Origins 262

      16.3.1 Early Development 264

16.4 Early Designs of Total Artifi cial Hearts 264

16.5 First Clinical Implantation of a Total Artifi cial Heart 265

16.6 First Clinical Applications of a Permanent Pneumatic Total Artifi cial Heart 265

16.7 The Development of Permanent, Implantable, Electrically Powered Artifi cial Hearts 266

16.8 First Clinical Application of an Intrathoracic Pump 267

16.9 First Clinical Application of a Paracorporeal Pump 267

16.9.1 Recent Developments 267

16.10 Total Artifi cial Heart 268

16.11 Heart Assist Devices 268

      16.11.1 Ventricular Assist Device (VAD) 268

16.12 Total Artifi cial Heart: Aortic Pumping System, Indian Initiative 269

      16.12.1 Novel Features 269

16.13 Existing Prior Technologies 270

      16.13.1 Diaphragm Pump 270

      16.13.2 Pulsatile Blood-Pumping System 271

      16.13.3 Orthotopic Total Artifi cial Heart 272

      16.13.4 Heart Assist Devices, Systems, and Methods 273

16.14 Disadvantages of Prior Developed Systems 274

16.15 Artifi cial Heart Pump 274

16.16 Multistaged Multi-Actuated Pump System (Fig. 16.4) 275

      16.16.1 Heart Pump Prototype Model 277

      16.16.2 Advantages of the Artifi cial Heart 277

Reading List 279

Problems 280

17 The Design of Heart Valves 281

17.1 Introduction 281

17.2 The Heart 281

17.3 Heart Valves 284

17.4 Cardiac Cycle 286

17.5 Cardiac Output 287

17.6 Artifi cial Heart Valves 291

      17.6.1 Potential Risks of Artifi cial Heart Valves 291

      17.6.2 Lifestyle Considerations 292

      17.6.3 Longevity and Replacements 293

17.7 Design of Valves 293

      17.7.1 Valve Descriptions 294

      17.7.2 Mechanical Valves 294

      17.7.3 Caged Ball Valve 295

      17.7.4 Tilting Disk Valve 295

      17.7.5 Bileafl et Valves 297

17.8 Biological Valves 298

      17.8.1 Homograft, Autograft 299

      17.8.2 Autologous Pericardial Valve 300

      17.8.3 Porcine Heterograft Valves (Stented) 300

      17.8.4 Porcine Heterograft Valves (Unstented) 301

      17.8.5 Bovine Pericardial Heterograft Valves 301

      17.8.6 Complications 302

      17.8.7 The Comparative Clinical Performance 302

17.9 Structural Deterioration of Biological Valves 303

      17.9.1 Porcine Valves 303

      17.9.2 Pericardial Valves 303

      17.9.3 Homografts 303

      17.9.4 Pulmonary Autograft 304

      17.9.5 Materials of Construction and Manufacture 304

      17.9.6 Assembly 305

      17.9.7 Sterilization and Packaging 305

      17.9.8 Quality Control 305

      17.9.9 The Future 306

17.10 Failure Modes in Mechanical Valves 306

17.11 Choice of Valves 307

17.12 Future Developments 307

List for Further Study 308

Problems 308

Example from the Literature for Valve Area Calculation 308

Aortic Valve Area Calculation 308

18 The Kidney and Its Artifi cial Replacement 311

18.1 Introduction 311

18.2 How Do Kidneys Help Maintain Health? 313

18.3 Diseases 313

      18.3.1 Chronic Kidney Disease (CKD) and Related Facts 313

      18.3.2 What Is Chronic Kidney Disease? 314

      18.3.3 What Causes CKD? 314

      18.3.4 The Symptoms of CKD 314

18.4 Dialysis 315

      18.4.1 Kidney Failure 315

      18.4.2 Hemodialysis 316

      18.4.3 Peritoneal Dialysis 316

18.5 The Artifi cial Kidney 317

      18.5.1 Parallel Flow Dialyzers 317

18.6 Coil Hemodialyzer 317

      18.6.1 Hollow Fiber Hemodialyzer 319

18.7 Performance Analysis of Dialyzers 319

      18.7.1 Ultrafi ltration Rate 321

      18.7.2 Residual Blood Volume 322

      18.7.3 Priming Volume 322

      18.7.4 Pyrogenicity 322

      18.7.5 Leakage Rate 322

18.8 The Hemodialysis Machine and Its Parts 323

18.9 Conclusions 323

      18.9.1 Dialysis Does Not Help Cure Kidney Disease 323

18.10 Recent Developments in Artifi cial Kidneys 324

      18.10.1 Nanotechnology 325

      18.10.2 Portable Dialysis Machine 326

List for Further Reading 328

Exercises 328

19 Skin and the Design of Artifi cial Skin 329

19.1 Anatomy of the Skin 329

19.2 Modeling of Soft Biological Tissues 330

      19.2.1 The Stress–Strain Relationship 331

19.3 Mechanical Properties of Soft Tissue 332

19.4 Fitting Hyperelastic Material Models to the Experimental Data 332

19.5 Artifi cial Skin 333

19.6 Tissue Expanders 335

References 337

Exercises 337

20 The Artifi cial Pancreas 339

20.1 Endocrine Physiology 339

20.2 Artifi cial Pancreas 340

20.3 Intensive Insulin Therapy and Insulin Pump 341

20.4 Bioengineering Approach to an Artifi cial Pancreas 343

20.5 Gene Therapy Approach 344

20.6 Medical Equipment Approach 345

      20.6.1 Development of Continuous Blood Glucose Monitoring 345

      20.6.2 Feedback of Real-Time Blood Glucose Data to an Insulin Pump for Basal Control 346

20.7 First Clinical Tests: Implantable Insulin Pumps and Continuous Glucose Sensors 347

20.8 Insulin and Amylin Combination 348

20.9 Feedback of Real-Time Blood Glucose Data to an Insulin Pump for Bolus Control 348

20.10 Glucagon Combination 349

20.11 Research Around the World 350

Reading List 350

Problems 351

21 The Liver and Its Artifi cial Replacement 353

21.1 Introduction 353

21.2 Blood Flow 354

21.3 Biliary Flow and the Biliary Tree 354

21.4 Lobes 355

21.5 Synthesis 355

21.6 Breakdown 356

21.7 Other Functions 356

21.8 Bioartifi cial Liver Device 356

      21.8.1 Function 357

      21.8.2 Hollow Fiber System 357

      21.8.3 Comparison to Liver Dialysis 357

21.9 Progress Toward an Artifi cial Liver Transplant 358

References and for Further Study 359

Problems 359

22 Female Organs and Their Artifi cial Replacements 361

22.1 Introduction 361

22.2 Breast Implants 362

      22.2.1 History 363

      22.2.2 Indications 363

22.3 Patient Characteristics 364

22.4 Types of Implants 365

22.5 Silicone Gel Implants 366

      22.5.1 First Generation 366

      22.5.2 Second Generation 366

      22.5.3 Third and Fourth Generations 367

      22.5.4 Fifth Generation 367

22.6 Implant Pocket Placement 367

22.7 Failure and Rupture 369

22.8 Implants and Mammography 369

      22.8.1 Breast Implant Manufacturers 370

      22.8.2 Artifi cial Breast Prostheses 370

22.9 Artifi cial Vagina 371

      22.9.1 Veterinary Use 371

22.10 Usage as Sex Toy 371

      22.10.1 Types 372

22.11 Materials 373

References 373

Problems 375

23 The Medical Device Market and Ethical Issues of Implants 377

23.1 Introduction to the Medical Device Market 377

23.2 Ethical Issues of Implants 379

      23.2.1 The Need for Implants 380

23.3 Treatment Modality 380

23.4 Transplants and Implants 381

23.5 Implant Failure 382

23.6 Clinical Trials 384

23.7 Ethical Issues of Dental Implants 384

23.8 Cost 385

23.9 Moral Uncertainties 385

23.10 Religion and Morals 386

23.11 Ethical Issues of Transplants 387

      23.11.1 Availability 389

23.12 Xenografts as a Solution 390

23.13 Life Expectancy 391

Suggested References for Further Details 393

Exercises 393

24 The Manufacturing, Testing, and Sterilization of Implants 395

24.1 Introduction 395

24.2 Casting 396

24.3 Forging 397

24.4 Metal-Shaping Machine Tools 397

24.5 Manufacturing Implants at a High Speed 399

24.6 Rapid Prototyping 400

24.7 Nonconventional Machining 402

24.8 Nondestructive Testing 403

24.9 Sterilization 404

      24.9.1 Physical Agent 405

24.10 Conclusions 408

For Further Reading, the Following References Are Given 408

For Computer-Aided Design and Manufacture 408

For Sterilization of Implants 409

Problems 409

Index 413

Professor, Biomedical Engineering, Former Founder Director, School of BioScience & Engineering Jadavpur University Research Professor KPC-Medical College & Hospital Professor, Biomedical engineering Founder Director, School of BioScience & Engineering Jadavpur University. Research Professor KPC-Medical College & Hospital Emeritus Fellow, School of Education Technology, JU

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