GALLERY

Cranial Technologies is a provider of medical devices used in the treatment of positional head molding (deformational plagiocephaly, see below) in infants.

Founded in 1986, CranialTech is dedicated to the treatment of infants with plagiocephaly. Over the past fifteen years their Clinics in the USA, Canada, Spain and the United Kingdom have provided care for over 20,000 babies. The DOC Band was the first device to be cleared by the U.S. Food and Drug Administration (FDA), and is the only device with clinical studies demonstrating safety and effectiveness.

Each DOC Band is custom made, using a 3D model of the child's head. CranialTech uses DeskProto to CNC machine these head models, based on 3D scan data.

The DOC Band® in use. Picture from the 2005 DOC Band Calendar.

While in many cases medical products are supplied to a hospital or a specialist, CranialTech both manufactures the product and provides the treatment.

Cranial Technologies maintains the largest database on deformational plagiocephaly in the world, and also funds research studies investigating the cause and prevention of plagiocephaly. Their research is published in peer-review medical journals and presented at national and international medical meetings. For more details see the CranialTech website.

Plagiocephaly

Brachycephaly

It is not uncommon for a baby's head to develop an unusual shape. Plagiocephaly (pla'je-o-sef'ah-le) often results from external forces applied to the soft infant skull.

Plagiocephaly literally means "oblique head" (from Greek: plagio = oblique, and cephale = head) It's called a parallelogram deformity because, if you look down the infant's head (bird's-eye-view), this is the shape you see. From this angle it looks as if half of the head has been pushed forward, often accompanied by misalignment of the ears, facial asymmetry and bulging forehead.

Left: Before. Brachycephaly. Right: After. Treatment began at 5 months of age.

Treatment of plagiocephaly is possible with a custom made 6-oz device, called the DOC Band, consisting of an outer plastic shell with a foam lining. Mild pressures are applied to hold the head growth in the prominent areas and encourage it in the flat regions.

However, successful treatment goes beyond just the device. The process begins with a detailed medical history and an exact scan of the infant's skull. A physical model is then manufactured from a corrected format, and the device is manufactured around this model. A precise fit is necessary, and growth adjustments must be carefully controlled for the child to achieve the optimal outcome, returning the infant's head to a normal shape.

Toolpaths in DeskProto. The CNC milling machine with rotation axis.

The manufacturing process of the band starts with a 3D scan. CranialTech uses the Infant digitizer designed by 3dMD. The scanning process needs to be very fast, as it is impossible to keep a child still, even for a few seconds. The scanner produces point cloud data, which can easily be converted to polygon data (triangles).

Next the computer-model of the head has to be modified, as for treatment of course the band needs to have a bit different shape. The data may also be simplified, as details like the exact shape of the ears are not relevant. The result is an STL file of the model to be machined.

After importing this STL file DeskProto calculates the toolpaths. As the parameter settings are the same for all models they are made default, and so this is extremely easy. The actual milling is done on a Millright machine made by MHO Corp.: see the illustration above. The result is a physical model, which is used to build the actual DOC Band.

The DOC Band® in use.

The use of a 3D scanner, DeskProto and CNC milling machine is a new development at Cranial Technologies. Currently, a portion of the DOC Bands are still being manufactured using the manual process involving casting.