Cephalometer for Rapid, Safe Measurement of Infant Head

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DESCRIPTION (provided by applicant): A cranial measurement device, or cephalometer is proposed that will provide a safe and convenient means for screening for and determining the severity and nature of plagiocephaly in an infant. Currently, initial screening by pediatricians is entirely subjective. The first quantitative evaluation is typically done with large calipers by a neurosurgeon or by radiographic means. However, there is need for an inexpensive device that either clinicians or parents can use to rapidly obtain accurate and repeatable data, both for screening and during the course of treatment. The proposed measurement device offers a practical method for obtaining frequent measurements, allowing the treating physician to evaluate the progress and effectiveness of treatment. This will benefit patients with conditions ranging in significance from deformational plagiocephaly, treated with orthotic devices such as helmets, to sagittal synostosis, a congenital skull abnormality requiring surgery. Although not a requirement, the proposed device can be upgraded to include sensors, data acquisition and a computer, in order to create a complete system in which measurements are displayed, evaluated, and diagnostic and record-keeping tasks undertaken. The Phase I will focus on development and test of several cephalometer prototypes. Testing will be done with infant head models that represent both normal head shapes and deformities of interest, in order to evaluate rapidity of measurement, measurement accuracy and repeatability (as compared with calipers and other accepted methods), measurement quality as a function of user's level of training (again, compared with existing methods), and device cost. Testing with infants will be deferred until the Phase II, in which measurements will be taken on many infants with a wide range of head shapes by parents, doctors, and other clinicians.