Cranial orthosis for preventing positional plagiocephaly in infants

Abstract

A cranial orthosis is contoured to match the curvature of the fronto-temporal, parietal and occipital areas of an infant's cranial vault to provide protection against the acquisition of postural cranial deformities as a result of the infant's sleeping in the supine position. The orthosis is designed to be of universal fit, as determined by the infant's fronto-occipital head circumference (FOC) measurement. The interior dimensions of the orthosis can be enlarged to accommodate growth of the infant's head without requiring replacement.

Description

PRIORITY STATEMENT & CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from co-pending U.S. patent application Ser. No. 10 / 620,070, entitled “Cranial Orthosis for Preventing Positional Plagiocephaly in Infants” and filed on Jul. 14, 2003 in the names of Frederick H. Sklar and Paul C. Hobar; which is hereby incorporated by reference for all purposes.FIELD OF THE INVENTION [0002] This invention is related generally to medical devices for preventing and treating cranial deformities in infants. In particular, the invention is related to a protective appliance or cranial orthosis in the form of a shell, helmet or headband that fits around a baby's head, and the use of the appliance to prevent positional plagiocephaly by redirecting the compressive forces that would otherwise be imposed on soft, compliant areas of the developing cranium by the head weight of an infant lying on a sleep surface in the supine position. DESCRIPTION OF THE RELATED ART [0003] Crani...

AI Technical Summary

Benefits of technology

"The present invention is a protective appliance for newborns and infants that provides a cranial orthosis to prevent positional plagiocephaly and other deformities of the cranium during the critical first twelve months of cranial development. The appliance is made of a durable, lightweight plastic material with a concave profile that matches the curvature and symmetry of the baby's head. It has a smooth interior surface that decouples the compressive forces of the sleep surface from the soft, vulnerable areas of the baby's head and allows the developing areas of the infant's head to expand freely into the smooth, contoured cavity of the protective shell. The appliance can be fitted effectively according to the age, gender, and fronto-occipital circumference measurement of the infant. It includes a crown portion, left and right wing portions, and rostral end portions that can be adjusted to fit different head sizes. The appliance is placed on the infant's head by spreading the rostral end portions and inserting the baby's head into the protective pocket, and then allowing the rostral end portions to return to their resting position. The appliance can accommodate normal head growth by peeling away the layers of soft, spongy material or fabric material from the interior surface of the protective shell."

Problems solved by technology

The “turn-over” repositioning treatment is not difficult to accomplish.

However, to be effective this technique requires careful monitoring of the baby, diligence and the close attention of parents during sleeping hours.

Although this seems simple in theory, in practice it is most difficult to accomplish consistently over the treatment term, which may extend up to 12 months, because of obligations parents may have to care for other children and attend to other matters, while at the same time trying to obtain the sleep and rest needed to carry on with work and other activities.

After twelve months of age or if the deformity is severe, torque helmets are of limited value and surgical cranial re-contouring may be required.

Treatment with these torque devices typically requires more time in older infants.

As a child's age approaches 12 months, torque treatment becomes less effective.

Moreover, the acquired distortion of the base of the skull, as evidenced by the forward displacement of the ear on the side of the occipital flattening, does not generally improve with torque treatment devices.

Because each orthosis is custom manufactured from an exact mold of the child's head, and because each device requires follow-up and modification as the child grows and the deformity responds, these devices are expensive and beyond the reach of many families, in particular those without effective insurance coverage.

Some commercial insurance companies do not reimburse for the manufacture and use of such cranial orthotic devices, because the cranial deformities are acquired and are not the result of craniosynostosis (suture fusion).

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