BACKGROUND

Orthopaedic fractures are a common daily acute health issue.
A significant increase of bone fracture cases is expected in the
coming years because of:

  • Population aging (Figure 1) and increased life expectancy with osteoporosis – the most common cause of fractures – increase of 200% in the next 30 years.
  • More active lifestyle.
  • Road traffic accidents (RTAs) and sport injuries


 

 

 

 

 

 

 

 

PROBLEM  

  • Fractured bone injuries are normally treated by deploying internal or external
    trauma fixation devices. The internal trauma fixation devices (Figure 2) are more widely used, 87.7% the overall trauma fixation devices market share in 2014 .
    Most standard metal internal fixators need to be removed after the fracture has healed.
    This needs open surgery under full anaesthesia, which is both costly and potentially dangerous.
    The global trauma fixation devices market is expected to grow at an annual growth rate of 6.9 % in the period 2014-2019 and to reach
    € 8 billion by 2020.
  • In 2008, fixation devices were used in approximately 420.000 surgeries in Europe, at costs of more than €4.8 billion. A significant portion of these costs (15%, €720 million) result from re-interventions needed because of failed surgical technique, usually caused by errors in the treatment of the fracture due to the low performance of the implants.
  • Renowned fixator manufacturers have been forced to perform product recalls

THE NEED

Current Material – Metal, CFR designed with pre-drilled holes

  • The holes and their angle are pre-fixed leaving little or no room for manipulation
  • Bone breakage (cut out) due to different modulus of nail/bone
  • CT and MRI dispersion – visual difficulties
  • Bone lysis – metalosis
  • Many holes weakens the plate

During surgery –

  • Long exposure to X-ray imaging
  • Limited location, number, and angle of pre-drilled holes
  • Extends surgery time

Post Surgery –

  • Significant scaring
  • High heat conductivity may cause pain at weather change

 

 

 

 

 

 

CLIENTS: hospitals, healthcare providers, medical doctors

CURRENT ALTERNATIVES

  Natural Nail ® Multiloc™ T2 Tibia Nail DIPHOS R MP-ORIF
EFFECTS DERIVED FROM THE MATERIAL
Composition Stainless Steel Titanium alloy Titanium alloy CFR-PEEK 30%* MP-1™
Causes Metalosis Yes Yes Yes No No
Feel of temperature Yes Yes Yes No No
Bone lysis High High High Medium None
Water Absorption Corrosion Corrosion Corrosion Yes No
EFFECTS DERIVED FROM THE IMPLANT DESIGN
Pre-drilled Holes Yes Yes Yes Yes No-dentations
Need Intraoperative imaging Yes Yes Yes Yes No
Generates Imaging artifacts Yes Yes Yes Yes No

 

OUR SOLUTION

MP-ORIF Polyimide nail or plate with no pre drilled holes

Benefits to surgeons and patients

  • Faster recovery (2 weeks instead of 4 months)
  • Faster surgery (45 min instead of 1hr 15min)
  • Less scaring (laparoscopy-like instead of long cuts)
  • No additional surgeries to remove the nail
  • No pain in changing weather
  • Better value for the hospital
  • Better access to trauma care in developing economies
  • Lower overall cost (no repeated X-rays, shorter hospitalization and medical-related costs)

 

 

 

 

 

 

 

 

 

Drilling and screwing in MP-1 nail in bone

 

 

 

 

 

 

 

 

 

 

 

 

 

 

No damage to nail or bone

First production of nail from compression molded powder

Design and construction of our unique press and mold

 

 

 

 

 

 

The Press

 

 

 

 

 

The Mold            The Near-Net-Shape Product   Machining

 

 

 

 

 

End Product

 

 

 

 

 


This Project has received funding from the European´s Union Horizon 2020 research and innovation programme under grant agreement No 767901.