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Development of cranial orthoses made by direct digital manufacturing

This project is focused on a new 3d printed cranial orthosis. This project will integrate available digital technologies (3d scanning, computational modelling, 3d printing). The goal is to develop new product (cranial orthoses) and production method (direct digital manufacturing process).

Since parents have been encouraged to place their infants prone (on their backs) from birth this has reduced the numbers of infants who die prematurely. Known as Sudden Infant Death Syndrome (SIDS) this policy has reduced premature infant deaths by over 60%, however it has also had the effect that approximately 5% of infants now develop a severe, permanent flattening to the back or side of their skulls. Orthotic cranial remoulding has been a recognised treatment since 1993 and was originally accomplished by taking a plaster cast of the infant’s head and making a padded fibre glass helmet which was made to a corrected head shape, allowing the head shape to develop into a more natural shape. Since these early days cranial remoulding orthoses (helmets) are now usually made to a 3D scan of the infant’s head shape which is then either carved and post carving rectifications are added or the original shape file is CAD modified and then carved. Since being introduced, neurosurgeons have found that the use of a cranial remoulding orthosis is useful in treating infants who have received surgery to open an prematurely fused suture between the plates in the skull. The use of such an orthosis continues to improve the head shape and provides protection to the developing infant skull. An orthosis, manufactured with a closed cell thermoplastic foam lining and a firmer copolymer shell is made to allow the infant head to reshape as it grows. There are up to 15 manufacturing processes involved in making an orthosis. There are known minor adverse side effects, mainly being that they can be difficult for the infant to wear initially due to sweating and can cause minor skin irritation. The project objectives are to modify and simplify the manufacturing process by eliminating several of the processes and to create a more user friendly product. Specifically the project aims are: 1. Develop and prove CAD modifications of the original body shape file 2. Use this original shape file to be the internal shape of the orthosis and develop a file to enable additive manufacture of the product 3. Develop the aesthetic and functional form of the new orthosis 4. Develop a new lining system which will eliminate the effects of sweat and heat and which will reduce the risks of skin abrasions 5. Reduce the time input required to make an orthosis 6. Develop opening / hinge / closure systems for use on the new orthosis 7. Develop clinician / manufacturer interface, training materials and a competent order routine 8. Bring to a point whereby the treatment system, including the product can be marketed. 9. Reduce the clinical time input involved in managing infants during treatment. The new product is projected to eliminate the issues of sweating and temperature control. It will also eliminate the issues of skin irritation when worn. It also opens the possibilities of a broader distribution of manufacture to local printing companies within the client's region. This will reduce time to user and the carbon footprint in product transport.
Acronym: 
3D-CRANI-ORT
Project ID: 
9 606
Start date: 
01-01-2015
Project Duration: 
36months
Project costs: 
260 000.00€
Technological Area: 
OTHER INDUSTRIAL TECHNOLOGIES
Market Area: 
MEDICAL / HEALTH RELATED

Raising the productivity and competitiveness of European businesses through technology. Boosting national economies on the international market, and strengthening the basis for sustainable prosperity and employment.