France US Uk Deutsch Italia to come...

NiTinol

Nitinol: Titanium/Nickel alloy

Memometal has been working with Nitinol since 1986. More than 20.000kg have been produced

  • Binary alloy 50%Titanium / 50%Nickel (vitually atomically equal)
  • Rate of impurity < 0.1%

  

Properties

           → Shape memory

Shape memory is used for staples: the feet and back of the staple become maleable through heating or at body temperature

  • Shape change temperature is variable from -20°C to +100°C
    • Hot shape memory: changes shape at 50°C
    • Warm shape memory: changes shape at 35°C
    • Cold shape memory: changes shape at 20°C
  • Force from 10 to 40kg/mm²
    • For a staple weighing 2 to 8 kg depending on height
  • Distortion: 4%

  

            → Superelasticity

Superelasticity is used for staples and anchors: the part naturally adopts its shape after implantation

  • Great elasticity with constant force
  • Purely elastic distortion up to 8%

   

         → Biocompatibility

Nitinol is inert: Nickel on its own is toxic, but a think layer of titanium oxide shapes on the surface creates a barrier against the nickel

Long-term biocompatibility is proven:

  • ISO 10993 standard
  • ASTM F 20 63 standard specific to Nitinol
  • Bibliography (biocompatibility evaluation of nickel-titanium shape memory alloy by J. Ryhänen)

    

       → IRM compatibility

IRM compatibility has been proven through a study performed at the Laboratoire de biomatériaux en site osseux (laboratory of osteo-biomaterial) and the laboratoire de résonance magnétique en biologie et médecine (laboratory of biological and medical magnetic resonance) at the University of Rennes

  

Rules of use of the MEMOMETAL implants:

Storage and transport at room temperature (even up to a temperture of 60°C)

Storage prior to surgery:

  • Cold memory: < -20°C during 2 hours minimum
  • Warm memory: <0°C  during 2 hours minimum
  • Hot memory: room temperature
  • Superelastic: room temperature

Heating the implant:

  • Cold memory: body temperature
  • Warm memory: body temperature
  • Hot memory: electric scalpel beated to 50°C
  • Superelastic: body temperature