Nitinol for Medical Devices - Grado Zero Espace Srl
Nitinol for Medical Devices - Grado Zero Espace Srl
Nitinol for Medical Devices - Grado Zero Espace Srl
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<strong>Nitinol</strong> <strong>for</strong> <strong>Medical</strong> <strong>Devices</strong><br />
Fundamentals of Shape Memory<br />
<strong>Nitinol</strong> Processing<br />
Design and Application<br />
Where is <strong>Nitinol</strong> Used?<br />
<strong>Medical</strong> Device Characteristics<br />
Design Case Studies<br />
Environmental Effects<br />
1
Applications of <strong>Nitinol</strong><br />
2
<strong>Nitinol</strong> History<br />
1970 First aircraft applications<br />
1975 Orthodontic arches — first superelastic application<br />
1980 Guidewires<br />
1985 Instrument components<br />
1990 Stents<br />
3
Where is <strong>Nitinol</strong> Used?<br />
Constrained Recovery<br />
4
Where is <strong>Nitinol</strong> Used?<br />
Actuators<br />
5
Where is <strong>Nitinol</strong> Used?<br />
Actuators<br />
<strong>Grado</strong> <strong>Zero</strong> <strong>Espace</strong> S.l.r.<br />
6
Where is <strong>Nitinol</strong> Used?<br />
Superelasticity<br />
7
Where is <strong>Nitinol</strong> Used?<br />
Thermal Actuation<br />
Dr. Charles Dotter<br />
9
Where is <strong>Nitinol</strong> Used?<br />
<strong>Medical</strong><br />
<strong>Devices</strong><br />
10
<strong>Nitinol</strong> <strong>Medical</strong> Device Characteristics<br />
Biomechanical<br />
Compatibility<br />
Elastic Deployment<br />
Thermal Deployment<br />
Kink Resistance<br />
Constancy of Stress<br />
Dynamic Interference<br />
Hysteresis / Biased Stiffness<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
11
MR Compatibility<br />
12
Guidewires<br />
Elastic Deployment<br />
Kink Resistance<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
SMA, Inc.<br />
13
Bone Reamers<br />
Kink Resistance<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
Zimmer<br />
14
Needle/Wire Localizer<br />
Elastic Deployment<br />
Kink Resistance<br />
Biocompatibility<br />
Homer Mammalok® (Mitek)<br />
15
RF Tissue Ablation<br />
Elastic Deployment<br />
Kink Resistance<br />
Fatigue Resistance<br />
Biocompatibility<br />
RITA <strong>Medical</strong> Systems, Inc.<br />
16
Baskets<br />
Elastic Deployment<br />
Kink Resistance<br />
Dynamic Interference<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
17
Organ Retrieval<br />
Elastic Deployment<br />
Kink Resistance<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
Covidien<br />
18
Snares<br />
Elastic Deployment<br />
Kink Resistance<br />
Dynamic Interference<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
ev3<br />
19
Embolic Protection <strong>Devices</strong><br />
BSC<br />
Abbott<br />
Elastic Deployment<br />
Kink Resistance<br />
Dynamic Interference<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
Cordis<br />
ev3<br />
20
Deflectable Instruments<br />
Endius Flextip<br />
Surgical Innovations<br />
Endius<br />
Elastic Deployment<br />
Kink Resistance<br />
Biocompatibility<br />
MRI Compatibility<br />
21
Flexible Micrograsper<br />
Bacher<br />
Elastic Deployment<br />
Kink Resistance<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
22
Heart Valve Sizer<br />
De<strong>for</strong>mable Martensite<br />
Fatigue Resistance<br />
Biocompatibility<br />
St. Jude<br />
23
Vascular Closure <strong>Devices</strong><br />
<strong>Nitinol</strong> Needles<br />
Perclose<br />
Elastic Deployment<br />
Kink Resistance<br />
Fatigue Resistance<br />
Biocompatibility<br />
Abbott<br />
24
Suture Anchor<br />
Biomechanical Compatibility<br />
Elastic Deployment<br />
Biocompatibility<br />
MR Compatibility<br />
Mitek 25
Bone Staples<br />
Biomechanical Compatibility<br />
Thermal Deployment<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
BME, Inc.<br />
26
Spinal Cage<br />
Depuy Spine<br />
Biomechanical Compatibility<br />
Elastic Deployment<br />
Biocompatibility<br />
MR Compatibility<br />
27
Septal Occlusion<br />
Biomechanical Compatibility<br />
Elastic Deployment<br />
Biocompatibility<br />
MR Compatibility<br />
AGA <strong>Medical</strong> W.L. Gore 28
Vena Cava Filters<br />
Cordis<br />
C.R. Bard<br />
29
Stents and Stent Grafts<br />
Stents use a wide range of properties<br />
Biomechanical Compatibility<br />
Elastic or Thermal Deployment<br />
Kink Resistance<br />
Constancy of Stress<br />
Dynamic Interference<br />
Hysteresis / Biased Stiffness (COF and Crush Resistance)<br />
Fatigue Resistance<br />
Biocompatibility<br />
MR Compatibility<br />
30
Neuro<br />
Carotid<br />
Esophagus<br />
Trachea<br />
Biliary<br />
Colon<br />
Urinary Tract<br />
“The human body is a<br />
series of tubes just waiting<br />
to be stented”<br />
Dr. Paul S. Teirstein, 1998<br />
Coronary<br />
Aorta<br />
Iliac<br />
Femoral<br />
Popliteal<br />
Non-Vascular<br />
Vascular<br />
31
<strong>Nitinol</strong> Self-Expanding Stents<br />
Coil Stents<br />
Woven Wire Stents<br />
“Wiggle Wire” Stents<br />
“Slotted Tube” Stents<br />
Abbott<br />
ev3<br />
BSC<br />
Medtronic<br />
32
Design: Case Studies of<br />
Engineering Challenges of Selected<br />
<strong>Nitinol</strong> <strong>Medical</strong> <strong>Devices</strong><br />
33
Case Study 1:<br />
Homer Mammalok<br />
A f = -10˚C, 14˚C, 27˚C<br />
Challenge: Determine the Effect of A f<br />
on Deployment Stress and Strain<br />
34
Effect of A f on Tensile Properties<br />
35
FEA of Hook Retraction<br />
36
FEA Strain Distribution<br />
δAf = TT - Af<br />
STRAIN<br />
37
FEA Stress Distribution<br />
δAf = TT - Af<br />
STRESS<br />
38
Case Study 2: Stents<br />
Challenges:<br />
Determine stresses and<br />
strains during loading<br />
and deployment<br />
Optimize in vivo <strong>for</strong>ces<br />
39
Loading into the Catheter<br />
41
Chronic Outward Force<br />
COF<br />
42
Radial Resistive Force (RRF)<br />
RRF<br />
43
Stress and Strain Analysis<br />
44
Stress - Strain Distribution<br />
45
Radial Force Testing<br />
Is there an ideal A f <strong>for</strong> a stent? What are the effects of A f ?<br />
46
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