Nitinol in der Medizintechnik

The seminar will focus on key performance attributes of Nitinol.

Ziel der Weiterbildung

The seminar will provide design guidelines for Nitinol components with consideration of fatigue and durability, biocompatibility and corrosion, MR compatibility as well as manufacturing aspects. Additionally, aspects of the additive manufacturing of Nitinol will be addressed.

Monday, 24th April 2023
8.45 - 12.00 and 13.00 - 16.45

1. Introduction and Shape Memory Basics (A.R. Pelton) 
- terminology 
- atomistic nature of the shape memory effect 
- shape memory and superelasticity 
- temperature and stress/strain hysteresis 
- biomechanical compatibility of Nitinol

2. Nitinol Material Characteristics (J. Ulmer) 
- differences and similarities from different melting techniques 
- understanding ASTM specifications 
- the ”inclusions” debate 
- specifying semi-finished material for Nitinol components 
- processing semi-finished materials (wire, tube, sheet)

3. Nitinol Devices and Manufacturing Techniques (A.R. Pelton) 
- vascular implants (stents, filters, occlusion devices) 
- component fabrication from wire, tube and sheet 
- laser cutting and post-processing 
- interventional and surgical instruments

4. Design of Medical Devices: Mechanical and Biocompatibility (A.R. Pelton) 
- elastic and thermal deployment 
- finite element modeling and lifetime prediction 
- performance and fatigue testing 
- surface properties of Nitinol 
- implant requirements 
- ASTM/ISO standards 
- surface preparation for optimum corrosion/biocompatibility

5. Regulatory Considerations for Nitinol Medical Devices (S. Nagaraja) 
- FDA regulatory pathway: 501(k), EFS, IDE and PMA 
- FDA Nitinol Guidance Document 
- EU MDR requirements