英国的研究人员Staffordshire University已经开发了具有综合感应能力的超低成本鞋垫，可以帮助防止威胁生命的糖尿病患者的脚步溃疡。
Rather than using electronic sensors to monitor ulcer development, the team’s 3D printed insoles feature tiny tunable structures, capable of reliably detecting where wearers overload their feet while walking. Using this deformation data, clinicians can potentially spot the early signs of ulcers in vulnerable patients, better managing their growth and preventing the need for life-changing amputations.
“Each year, more than 26 million people worldwide develop diabetic foot ulcers and the lifetime incidence of foot ulcers in developing countries is more than 20% among people with diabetes,” explained study co-author Professor Nachi Chockalingam. “Establishing low-cost methods to help prevent foot ulcers will reduce the global socioeconomic burden of diabetes and ultimately save lives.”
“The concept reported within this paper, with further development, has the potential to transform clinical management of foot ulcer risk across the world.”
糖尿病的致命副作用
感觉神经病是许多2型糖尿病患者的生活经验，因为该疾病会逐渐造成神经损伤和腿部和/或脚的感觉丧失。结果，许多患者不再感到四肢疼痛，这意味着他们的脚比以前更加严重，从而引发了糖尿病足溃疡的发作（DFU）。
Although DFU may initially sound trivial, it can effectively open wounds that go unnoticed and become infected, thus diabetes is now the world’s most common non-traumatic cause of amputation. In general, clinicians agree that reducing plantar pressure is vital to therapeutically managing diabetic feet, and they often prescribe footwear that’s designed to protect ulcerated areas from high loading.
Such orthotics have been in popular use for some time now, but their design is more reliant on the clinical intuition of GPs, than evidence of when diabetic foot pressures pass critical levels. Where complex shoe pressure-monitoring systems do exist, they often rely on expensive electronic sensors and cumbersome data tracking devices, which prevent their application within real-world scenarios.
As a result, the Staffordshire team has identified a need to act on the mounting evidence that pressure threshold-based devices are more likely to reduce the risk of recurrent DFU than current orthotic footwear, and proposed that 3D printing insoles with integrated sensory elements, could help identify overloaded foot areas more accurately moving forwards.
A novel low-cost insole design
Composed of a series of tiny conjoined hexagonal structures, the team’s TPU-based insole design is highly-flexible, and features a spring-like response under low pressures. However, once loading on the device has reached a pre-programmed critical compression level, its resistance effectively drops, allowing it to shield diabetic feet from continued pressure.
经过一周的使用后，团队还认为，鞋垫的微观结构可能会累积损坏，改变其机械性能并允许他们绘制脆弱的脚部区域。为了评估其新型设计的可行性，研究人员选择了FDM 3D打印26个样品，每个样品各有七个六角形结构，然后再对其进行机械载荷测试。
在2,000个测试周期之后，与平均糖尿病的每日步数一致，这些设备不仅显示出长期耐用性，而且还具有252 kPa的定义压力阈值。此外，通过以后的有限元（FE）分析，该团队发现可以提高或降低此断裂点以满足特定应用的需求，甚至可以量身定制以创建特定于患者的鞋垫。
Although the researchers concluded that their design requires further development before it can be applied within clinical settings, they maintain that it proves the viability of using thin-walled structures as a sensory diagnostic tool, and their potential to “enhance ulceration risk assessment and inform the design of effective offloading interventions.”
“Our work has demonstrated a method to reliably detect overloading using a low-cost non-electronic technique,” concluded the study’s lead author Dr Panagiotis Chatzistergos. “We have used a 3D printed thin-wall structure that changes its properties when repeatedly loaded above or below a tunable threshold. We believe that this is a step change from current practice.”
Additive manufactured orthotics
The customization and design flexibility unlocked through additive manufacturing has increasingly seen the technology being used within footwear fabrication applications. Earlier this month, 3D model marketplacePROTIQlaunched a基于3D打印的鞋裁缝工具that allows shoemakers to design and order bespoke orthopaedic footwear for clients.
同样地，拜耳foot care subsidiaryScholl博士has previously worked with Wiivv to develop a line ofcustomized 3D printed insoles。Now known asFitMyFoot, the firm’s technology allows users to 3D scan their feet and create personalized footwear, that’s designed to help reduce client foot pain and improve their body alignment.
在其他领域，还部署了3D打印来通过创建来帮助糖尿病患者无疼痛的葡萄糖监测devices, such as the ‘e-ring’ developed at the雅典国立和卡普迪斯特里大学。一旦连接到标准智能手机，这种新型设备就可以使用生物标志物在佩戴者的葡萄糖水平上提供超专有的读数。
研究人员的发现在其论文中详细介绍了“在日常生活活动中，低成本非电动检测到脚上超载的新颖概念,” which was co-authored by Panagiotis E. Chatzistergos and Nachiappan Chockalingam.
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图像显示了团队的3 d印刷传感器-insole and hexagonal internal structures. Image via the Royal Society Open Science journal.
