Inexpensive Foot Digitizing Device for Diabetic Footwear

描述(由申请人提供)：使用CAD/CAM设计和制造定制鞋垫有可能彻底改变对有足部溃疡风险的糖尿病患者的护理，从而防止截肢。使用这种方法，矫形器的个性化可以变得比使用仍然常见的手工制作更精确、更一致，而且成本更低。有几家公司已经开发了这样的系统&对每一家公司来说，准确测量脚型是至关重要的。现有的方法使用复杂的数字化机器来捕获足部几何图形，并使用CAD/CAM来创建鞋垫。这些系统非常昂贵，其中很大一部分成本是脚部数字化设备造成的。这项修订提案的目标是开发一种廉价的设备，触觉透镜，并将其推向市场，以捕捉足底表面的三维形状。拟议设计的主要优点是高分辨率、低成本和简单，这将使其适用于小型诊所和办公室。在这项研究的第一阶段，我们开发了第二代触觉透镜的原型，编写了获取和处理数据的软件，并使用优化方法显示了精确度和重复性方面的有希望的结果。在这个拟议的第二阶段，我们将改进这个原型和配套的软件，降低它的成本，并为它的上市做好准备。具体地说，我们将优化膜的安全性和硬度，增加内部校准、坚固的包装、对象稳定装置和应用负载测量。该软件将进行改进，以增加自动校准、操作员预览、更快的执行、自动图像处理和输出，这些功能可以轻松集成到CAD-CAM鞋类算法中。性能将通过对已知几何形状的物体进行精度测试来确定--在人的脚上。我们还将制定操作员培训协议和基于网络的说明。这个项目是DIApedia为高危糖尿病患者设计矫形系统的整体努力的关键部分，该系统基于明确的科学支持的设计算法。

DESCRIPTION (provided by applicant): The design and manufacture of custom insoles using CAD/CAM has the potential to revolutionize the care of diabetic patients at risk for foot ulceration, thereby preventing amputations. Using this approach, individualization of orthotics could become much more precise, consistent & less expensive than utilizing the still usual handcrafting. Several companies have developed such systems & for each the accurate measurement of foot shape is critical. Existing approaches use sophisticated digitizing machines to capture foot geometry and CAD/CAM to create insoles. These systems are very costly, & a significant portion of this cost is due to the foot digitizing devices. The objective of this revised proposal is to develop and bring to market an inexpensive device, the Haptic Lens, to capture the three-dimensional shape of the plantar surface of the foot. The major strengths of the proposed design are high resolution, low cost, & simplicity, which will make it accessible for use in small clinics & offices. In phase I of this study we have developed a second generation prototype of the Haptic Lens, written software to acquire and process the data, and used optimization methods to show promising results for the accuracy and repeatability. In this proposed phase II we will refine this prototype and accompanying software, reduce its cost, and prepare it for market. Specifically, we will optimize membrane safety and stiffness, add internal calibration, robust packaging, subject stabilization devices, and applied load measurement. The software will be refined to add automatic calibration, operator preview, faster execution, automatic image processing, and output that can easily be integrated into the CAD-CAM footwear algorithms. Performance will be defined through accuracy tests on objects of known geometry & on human feet. We will also develop operator training protocols and web-based instructions. This project is a critical part of an overall effort at DIApedia to design an orthotic system for at-risk diabetic patients that is based on clear scientifically supported design algorithms.