MULTISITE ULTRASONOMETER FOR OSTEOPOROSIS ASSESSMENT

本项目的目的是研制一种便携式、多部位、低成本、快速、简便的骨质量定量评估装置，适用于骨质疏松症危险人群的大规模筛查和早期识别。该设备将通过一些电子开关超声探头测量几个骨骼部位的超声波速度和频率相关的衰减。该探头用于短骨(跟骨)、长骨(尺骨、桡骨、胫骨)和扁平(髂骨)骨的表面和透射式发声，并普遍存在骨小梁、致密型或混合型骨结构。在初步的临床试验中，这种多部位方法显示了强大的诊断潜力。L阶段的主要目标是：(1)通过增加衰减测量的新算法、建设性地更换探头、提高测量质量和标准化定位的新工具，将早期原型开发为准备用于临床测试的设备；(2)展示所开发设备的潜在诊断价值。该项目在Il期及以后的继续进行将产生一种功能性人体工学仪器，用于对与年龄、性别和骨骼部位有关的正常和病理情况下的骨质量进行大规模筛选。建议的商业应用：紧凑型多部位骨超声仪将作为一种大规模筛查工具，用于初步检测骨质疏松。与现有的定量超声仪相比，它有许多优点，包括操作简单、成本较低、在类似灵敏度下显著减小了尺寸和重量。提出的装置提供了一种新的、复杂的方法来评估骨密度。随着人们对骨质疏松症认识的成熟，初级保健市场不断增长，这种设备有巨大的市场潜力。

The purpose of this project is to develop a portable, multi-site, low cost, fast and facile device for quantitative assessment of bone quality that is suitable for mass screening and early identification of osteoporosis risk group. The device will measure ultrasound velocity and frequency- dependent attenuation in several skeleton sites by a number of electronically switched ultrasonic probes. The probes are intended for surface and through transmission sonification of short (calcaneus), long (ulna, radius, tibia) and flat (ilium) bones with prevalence of trabecular, compact or combined types of bone structure. The multi-site approach has demonstrated a powerful diagnostic potential in preliminary clinical trials. The main objectives of Phase l are: (1) to develop an early prototype into a device ready for clinical testing by adding new algorithms for attenuation measurement, constructively changing probes, increasing quality of measurements, and new tools for standardized positioning; (2) to demonstrate potential diagnostic value of the developed device. Continuation of this project in Phase Il and beyond will result in a functional ergonomic instrument for mass screening of bone quality in normal and pathology, related to age, sex, and skeletal site. PROPOSED COMMERCIAL APPLICATIONS: The compact multi site bone ultrasonometer will serve as a mass screening tool for the primary detection of osteoporosis. There are multiple advantages over currently existing quantitative ultrasonometers, including ease of operation, lower cost, and significantly lower size and weight at comparable sensitivity. The proposed device offers a novel, complex approach to assessment of the bone density. There is a tremendous market potential for such device with the primary care market continuously growing in response to the maturing awareness of osteoporosis.