CAD-CAM Technology for Diabetic Footwear

描述（由申请人提供）：超过15%的糖尿病患者会经历足部溃疡。就护理费用和工作效率损失而言，足溃疡都是昂贵的。足部溃疡也是导致美国每年有超过8万例糖尿病患者截肢的主要原因。为了防止溃疡和截肢，有风险的患者必须终身使用特殊的鞋子，作为综合护理和自我保健计划的一部分。目前，治疗鞋的设计和制造在很大程度上是基于主观标准。成功的鞋子通常由经验丰富的工匠制作，并且经常需要反复制作。已经进行了几次尝试，将关键的鞋脚界面（鞋垫）的设计过程放在定量的基础上。由于缺乏将患者属性转化为鞋垫设计的明确算法，这些产品似乎并没有特别成功。我们将为高危糖尿病患者开发一套完整的治疗鞋系统，包括：数据收集；鞋垫设计自动算法；CAD-CAM制造系统；和系统的鞋子选择，包括外底修改。最终产品还将包括对提供者和患者进行教育的手段以及促进适当护理和自我护理的产品。第一阶段的初步研究表明，在足底压力、足形和足弓形状领域的数据采集取得了成功。开发了鞋的尺寸和与鞋模板的压力和形状数据对齐的算法。一种基于形状和压力数据在计算机屏幕上可重复设计鞋垫修改的方法现在已经存在，并且可以使用CAD-CAM系统虚拟设计鞋垫。从患者保持愈合的数据集已经获得，这是第一次为鞋内压力溃疡阈值的识别提供指导。我们还证明了整个过程的可行性，利用该方法将一组第一跖骨头高压的神经病高危足的鞋内压力降低到阈值以下。我们现在看到了进一步自动化系统的清晰路径，并考虑到足部的其他“危险”区域。

DESCRIPTION (provided by applicant): Over 15% of diabetic patients will experience a foot ulcer. Foot ulcers are expensive both in terms of cost of care and work productivity lost. Foot ulcers are also the dominant contributory cause to the more than 80,000 amputations performed in the US each year in diabetic patients. In order to prevent ulcerations and amputations, at-risk patients must use special footwear for life as part of a comprehensive care and self-care program. Currently the design and manufacture of therapeutic footwear is largely based on subjective criteria. Successful shoes are usually made by experienced craftspeople and much iteration is often required. Several attempts have been made to put the design process for the critical shoe-foot interface (insole) on a quantitative basis. These products appear to have not been particularly successful because of the lack of a well-defined algorithm to translate patient attributes into insole design. We will develop an entire therapeutic shoe system for at risk DM patients that will incorporate: data collection; automatic algorithm for insole design; CAD-CAM system for manufacture; and system for shoe selection including outsole modifications. The final product will also include a means for provider and patient education and products to promote appropriate care and self-care. Phase I preliminary studies have demonstrated success in data acquisition in the areas of plantar pressure, foot shape and arch shape. Algorithms for shoe sizing and alignment of the pressure and shape data with the shoe template have been developed. A method for reproducible design of insole modifications on the computer screen, based on the shape and pressure data, now exists and virtually designed insoles can now be milled using the CAD-CAM system. A data set from patients staying healed has been acquired that for the first time provides guidance for the identification of an in-shoe pressure ulceration threshold. We have also demonstrated feasibility of the whole process by utilizing the method to reduce in-shoe pressure below threshold in a group of neuropathic high-risk feet with high pressure at the first metatarsal head. We now see a clear path toward further automation of the system and to a consideration of other "at-risk" regions of the foot.