Cephalometer for Rapid, Safe Measurement of Infant Head

描述（由申请人提供）：提出了一种颅骨测量装置或头影测量仪，可提供一种安全方便的方法，用于筛查和确定婴儿斜头畸形的严重程度和性质。目前，儿科医生的初步筛查完全是主观的。第一次定量评估通常由神经外科医生使用大卡尺或通过放射学手段进行。然而，需要一种便宜的设备，临床医生或父母可以使用它来快速获得准确和可重复的数据，用于筛查和治疗过程。所提出的测量设备提供了一种用于获得频繁测量的实用方法，允许治疗医生评估治疗的进展和有效性。这将使患者受益，这些患者的情况从变形性斜头畸形（用头盔等矫正装置治疗）到矢状骨结合（一种需要手术的先天性颅骨异常）不等。虽然不是一个要求，但拟议的设备可以升级，包括传感器，数据采集和计算机，以创建一个完整的系统，其中显示，评估测量，并进行诊断和记录保存任务。 第一阶段将重点开发和测试几个头影测量仪原型。将使用代表正常头部形状和感兴趣的畸形的婴儿头部模型进行测试，以评价测量的快速性、测量精度和可重复性（与卡尺和其他公认的方法相比）、作为用户培训水平函数的测量质量（再次与现有方法相比）和器械成本。婴儿测试将推迟到第二阶段， 父母、医生和其他临床医生将对许多具有各种头部形状的婴儿进行测量。

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.