In-Shoe Plantar Shear and Pressure Sensing System

描述（由申请人提供）：足部溃疡是一种糖尿病并发症，估计仅在美国每年就导致超过10亿美元的医疗费用。越来越多的证据表明，升高的外力（压力和剪切力）和改变的组织特性的组合在足部溃疡的病因学中至关重要。尽管用于测量足底压力的商业平台和鞋内系统已在临床使用中，但可测量水平剪切力和垂直压力两者的系统仍有待开发和商业化。拟议研究的总体目标是开发一种多点鞋垫系统，该系统可以准确地表征足底表面上的压力和剪切力，足够薄和灵活，以提供与正常脚-鞋相互作用的最小干扰，可以容易地制造，并保持足够的研究和临床使用的校准。 在我们的第一阶段计划中，我们将开发一个由9个传感器组成的阵列，并附带电子设备，可以精确测量高达700 kPa的正常压力和高达200 kPa的剪切力。我们将把这个阵列集成到一个薄的，灵活的，顺应性的结构中，这将成为第二阶段鞋垫系统的基础，我们将使用两个专门开发的测试夹具进行实验室测试，以证明传感器阵列的性能符合我们的成功标准，包括尺寸，精度和校准稳定性。 第一阶段的成功将导致在第二阶段全面实施具有100多个传感器的鞋垫系统。我们还计划在第二阶段将该系统与正在开发的软件集成，以实现足部压力和剪切数据的可视化（1 R43 DK 61164 - 01 A1，第二阶段合同待定）。然后，将利用从糖尿病患者和正常患者收集的数据来评估组合的鞋垫传感器和可视化软件系统。一个完整的硬件和软件分析系统的商业可用性，以测量压力和剪切力将大大提高诊断，预防和治疗糖尿病患者的足部溃疡。

DESCRIPTION (provided by applicant): Foot ulceration is a diabetic complication estimated to result in over $1 billion worth of medical expenses per year in the United States alone. Increasing evidence indicates that a combination of elevated external forces (pressure and shear) and altered tissue properties is of prime importance in the etiology of foot ulcers. Although commercial platform and in-shoe systems to measure plantar pressure are in clinical use, a system that can measure both horizontal shear and vertical pressure remains to be developed and commercialized. The overall goal of the proposed research is to develop a multipoint, insole system that can accurately characterize both pressure and shear across the plantar surface, is thin and flexible enough to provide minimal interference with normal foot-shoe interaction, can be easily manufactured, and holds calibration sufficient for research and clinical use. In our Phase I program we will develop an array of 9 sensors with the accompanying electronics that can accurately measure applied normal pressure as high as 700 kPa and shear as high as 200 kPa. We will integrate this array into a single thin, flexible, compliant structure that will form the basis for a Phase II insole system and we will perform laboratory testing using two specially developed test fixtures to demonstrate sensor array performance against our success criteria for size, accuracy and stability of calibration. Success in Phase I will lead to full-scale implementation of an insole system with over 100 sensors in Phase II. We also plan in Phase II to integrate the system with software in development for visualization of foot pressure and shear data (1 R43 DK61164-01A1, Phase II award pending). The combined insole sensor and visualization software system would then be evaluated with data collected from both diabetic and normal patients. Commercial availability of a complete hardware and software analysis system to measure pressure and shear will greatly improve the diagnosis, prevention, and treatment of foot ulcers in diabetic patients.