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ular, shoulder, arm, elbow, hand, combinations of forearm-wrist, forearm-wrist-hand, forearm-wrist-thumb as well as lower-limb orthoses for knee, ankle-foot, knee-ankle-foot are commonly used. Sport rehabilitations require an array of orthoses in the form of braces. Prophylactic, functional and knee rehabilitation, and unloader braces are mainly used in sports applications. Other important implementations of orthotics are in spinal and dental medicine.


in facial asymmetry. Sometimes this large area of flattening distorts the skull greatly, making it parallelogram-shaped. Other similar disorders include: brachycephaly, a sym- metrical flattening of the occiput where infants or babies have little or no rounding on the back of their head and appear to have a disproportionate and wide head; and scaphocephaly— an elongated (long and narrow) head shape with compen- satory growth in the front and back of the skull as well as asymmetric brachycephaly, a complex disorder of combined brachycephaly and plagiocephaly.


Craniosynostosis can cause a deformational head shape due to premature joining of a skull’s sutures and may require surgery. Non-synostotic or positional plagiocephaly does not require surgery and mild cases may correct themselves within the first six weeks after birth without any interference. However, more serious cases can be treated with a custom- made head band or helmet by redirecting the skull growth to achieve symmetry. A few weeks after starting to wear the orthosis the babies exhibit improvement. However, the patients should continue to wear the device until full sym- metry is achieved. As the baby’s head grows, the head band or helmet needs to be adjusted by a qualified practitioner for proper fit and function.


Orthomerica's STARlight Pro has a side-opening band and is the first helmet for postendoscopic craniectomy. It is used to treat post-operative craniosynostosis. It is custom fabricated from a plaster cast or STAR scan. It is made from a clear plastic shell with foam pads.


We’ll look closely at the design and manufacturing of cranial remolding orthoses—head bands and helmets—as well as at body shields for protection of organs after surgeries or transplants. Both groups of orthoses are simple in terms of their design and manufacturing, but have to conform to a certain anatomic form and material requirements.


Cranial Remolding Orthosis Cranial remolding orthosis are employed when an infant


or baby’s head have deformational or positional anomly. Defor- mational plagiocephaly is a condition where a baby’s head has a flattening appearance on one side of the head resulting


50 www.sme.org/manufacturingengineering | May 2012


Since the 1970s, several remolding helmets and associ- ated protocols for treatment have become available. In 1998, the FDA categorized cranial orthosis as a Class II medical device, imposing strict regulations and requiring 510(k) clear- ance. To avoid this expensive and labor-intensive process, many orthotists stopped providing this important device.


Different Companies and Different Cranial Remolding Orthoses There are different types of cranial remolding orthoses for different anomalies mentioned above. Remolding orthoses are most effective within 4–12 months of the birth. Variation also exists in terms of plastic materials used, presence or absence of soft lining materials, straps, and ventilation holes. Companies such as Ballert Orthopedic (Chicago, IL) fo- cus on the complete coverage of the cranium with a helmet design. According to the company, many orthotists focus primarily on the upper cranial vault with their remolding bands. However, infants and babies have sutures over and around their ears as well as on the top of their head. The re- molding helmet designs restrict skull growth in the direction of the bulge while encouraging its growth in the direction of the flattening making them effective. In this company’s view,


Photo courtesy Orthomerica


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