ACOUSTIC PEDIATRIC OSTEOMETER FOR LONG BONE ASSESSMENT

本计画的目的是研制一种新型的便携式小儿声波骨量计。申报器械将执行多种诊断功能：评估骨矿化和生长过程，以及检测儿童和青少年长骨中的肿瘤样病变。通过探头线性阵列沿骨沿着进行离散超声处理，APO将生成位于生长区附近的干骺端和骨干中的检查部位的超声速度曲线。用于单向或双向测量的探头将相应地应用于软组织层薄（尺骨远端、胫骨）或厚（肱骨、股骨近端）的部位。在初步临床研究中证实了这种方法的多功能诊断潜力，包括检测青春期和生长突增期尺骨干骺端的矿化滞后，识别慢性肾脏疾病期间的全身性矿物质缺乏，以及检测肱骨近端的单房性骨囊肿。第一阶段的主要目标是：（1）开发一个带有线阵探头、微处理器测量单元和PC接口的APO原型设备;（2）通过模型研究验证设备的诊断价值，并为第二阶段进一步进行的临床试验做准备。拟议的商业应用：便携式声学小儿骨测量仪（APO）设计用于筛查和监测生长、青春期和成熟期间的骨矿化质量，以及检测慢性内分泌和代谢疾病期间的骨质减少。这种无辐射设备是用于所提出的应用的独特工具，还提供多功能性、易于操作、紧凑性和低成本。随着人们对发育健康的日益关注，APO具有巨大的市场潜力。

The aim of this project is to develop a novel portable Acoustic Pediatric Osteometer (APO). The proposed device will perform multiple diagnostic functions: assessment of bone mineralization and growth processes, and detection of tumor-like lesions in long bones of children and adolescents. By discrete sonication along a bone by linear array of probes, the APO will generate an ultrasound velocity profile of the examination cite, located in metaphyses near growth zones and in diaphyses. Probes for one- or two-way measurements will be applied to cites with thin (distal ulna, tibia) or thick (humerus, proximal femur) soft tissues layers, correspondingly. A versatile diagnostic potential of this approach was demonstrated in the preliminary clinical studies, that included detection of the mineralization lag in ulnar metaphyses during pubescence and growth spurt, identification of generalized mineral deficiency during chronic renal disorders, and detection of unicameral bone cysts in proximal humerus. The main objectives of Phase I are (1) to develop an APO prototype device with linear array probes, microprocessor measurement unit and PC interface; (2) to validate the diagnostic value of the device through model studies and to prepare for the clinical trials that will be performed further in Phase II. PROPOSED COMMERCIAL APPLICATIONS: The portable Acoustic Pediatric Osteometer (APO) is designed for screening and monitoring of bone mineralization quality during growth, pubescence and maturation, and for detection of osteopenia during chronic endocrine and metabolic diseases. This radiation-free device is a unique tool for the proposed application that also offers versatility, ease of operation, compactness, and low cost. There is a significant market potential for APO in response to growing concern for the developmental health.