On-Body Passive-RFID Antenna Array and Testbed to Assess Changes in Bone Structure

项目摘要/摘要 超过1000万美国人患有骨质疏松症，另有3600万人患有低骨密度，或 骨量减少。骨质疏松症是一个主要的健康问题，导致全国 医疗保健费用。目前检测骨质疏松症的方法依赖于电离技术，如双能 X线骨密度仪(DXA)和定量计算机断层扫描(QCT)。我们进行的一项初步研究 合作者指出，被动皮肤900 MHz无线电阵列的读数之间可能存在关联 手腕周围的频率识别(RFID)标签和通过以下方式确定的骨质疏松情况 DXA测量。因此，我们假设一个专业的习得试验台，使用这本小说低- 价格低廉的非电离技术，可以检测出骨质疏松。 具体目标1(第一阶段)：设计并构建一种新型车载无源RFID天线阵试验台 用于高灵敏度和可重复的腕骨信号测量。与常见的 微波成像设置有多个天线，使用一个RFID阵列而不是一个标签是唯一的 旨在更准确和稳定地读取单个参数-平均接收功率通过 手腕--有不同的解剖和生理条件。 具体目标2(阶段I)：确定试验台测量的骨信号的灵敏度 用于区分正常和骨质疏松的手腕骨使用体内先导研究。这个 第一阶段(和部分第二阶段)的最终技术目标是实现足够的测量精度 试验台，即保证每个手腕的平均接收功率变化性小于0.5分贝(系数 1.1)至少75%的测试手腕。该阈值将使提取所需信号成为可能 从周围的噪音中检测到与骨质疏松症相关的功率变化，预计将在 范围2-5分贝(1.6-3.2倍)。 具体目标1(第二阶段)：最终确定主要天线概念并保护RFID天线骨骼 密度试验台通过申请至少一项全尺寸专利，特别强调 阅读器/标签天线阵列设计，以及可能的扩展。将RFID天线试验台改装为 半商业化产品。本研究的一个特点是一种新颖而独特的车身天线 这将使我们能够在实践中实现一种高灵敏度的检测方法。 具体目标2(第二阶段)：通过执行和校准最终的RFID天线试验台 处理具有代表性的体内研究并提供最终的检测方案。最终确定并 对开发的腕部传感RFID设备进行上市前监管提交至美国。 卫生与公众服务部、食品和药物管理局、设备和医疗中心 放射健康。我们假设，新设计的试验台将区分正常、 骨质疏松和骨质疏松足以保证FDA在上市前提交的与 特定的III类设备。 具体目标3(第二阶段)：通过与更大的医疗公司合作来接近生产阶段 公司或第三方制造商。潜在的候选者包括Biotronik、波士顿科学公司、圣裘德 医疗公司和美敦力公司

PROJECT SUMMARY/ABSTRACT More than 10 million Americans have osteoporosis, and an additional 36 million have low bone density, or osteopenia. Osteoporosis represents a major health problem, resulting in substantial increases in national health care costs. Current methods to detect osteoporosis rely upon ionizing techniques such as Dual-energy X-ray Absorptiometry (DXA) and Quantitative Computed Tomography (QCT). A pilot study conducted by our collaborators indicated a possible correlation between readings of an array of passive on-skin 900 MHz Radio Frequency Identification (RFID) tags surrounding a wrist and an osteoporotic bone condition established via DXA measurements. We therefore hypothesize that a professional acquisition testbed, using this novel low- cost non-ionizing technique, can detect osteoporosis. Specific Aim 1 (PHASE I): Design and construct a novel on-body passive-RFID antenna array testbed for highly-sensitive and repeatable measurements of wrist bone signature. In contrast to a common microwave imaging setup with multiple antennas, the use of an RFID array instead of one tag is solely intended for more accurate and stable reading of the single parameter – the average received power through the wrist – given different anatomical and physiological conditions. Specific Aim 2 (PHASE I): Determine the sensitivity of the bone signature measured by the testbed for differentiating between normal and osteoporotic bones at wrists using in-vivo pilot studies. The ultimate technical goal of Phase I (and partially of Phase II) is to achieve a sufficient measurement accuracy of the testbed, i.e. guarantee the average received power variability for each wrist of less than 0.5 dB (factor of 1.1) for at least 75% of tested wrists. This threshold value will make it possible to extract the desired signal from the surrounding noise and detect the osteoporosis-related power variation, which is expected to be in the range 2-5 dB (factor of 1.6-3.2). Specific Aim 1 (PHASE II): Finalize the major antenna concepts and protect the RFID antenna bone density testbed by filing at least one full-scale patent with the special emphasis on the unique reader/tag antenna array design, and on possible extensions. Convert the RFID antenna testbed to a semi-commercial product. One feature of the present study will be a novel and unique on-body antenna design, which will allow us to realize a highly-sensitive detection method in practice. Specific Aim 2 (PHASE II): Calibrate the finalized RFID antenna testbed by performing and processing a representative in-vivo study and delivering a final detection protocol. Finalize and perform premarket regulatory submission of the developed wrist sensing RFID device to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. We hypothesize that the newly designed testbed will differentiate between normal, osteopenic and osteoporotic bone sufficiently to warrant a premarket regulatory FDA submission related to a specific Class III device. Specific Aim 3 (PHASE II): Approach the production stage by either teaming up with a larger medical company or a 3rd party manufacturer. Potential candidates include Biotronik, Boston Scientific, St. Jude Medical, Inc. and Medtronic, Inc.