Data-driven fitting for the next generation of prosthetic sockets

Radii的动机是需要为全球1.7亿截肢者改善假肢的装配。对于患者来说，这是当务之急：一个合适的假肢窝是实现活动和参与社会的决定性因素；对于诊所来说：随着假肢需求的增加，成本负担的增加，因此需要支持义肢医生更快、更少地实现完美的套孔配合。假肢插座是残肢与假肢部件之间的接口。无论组件多么先进，如果插座的形状或尺寸错误，或者压力分布与用户的需求不匹配，那么肢体将完全无用。由于患者肢体形状、软组织刚度和局部负荷容忍度的变化，这些骨臼的设计很复杂。拒绝率为31%。自2014年以来，南安普顿大学的研究人员在包括Opcare在内的供应商和患者的指导下，开发了满足患者和诊所需求的技术。Radii Devices正在将这项技术应用于临床。该项目将开发一个革命性的系统，以支持义肢医生设计义肢插座，用数据和人工智能支持复杂的矫正过程，以更快、更少的患者预约实现更好的设计，实现完美的配合。*技术：第一个在插座设计过程中提供数据驱动支持的解决方案，能够设计充分利用尖端3D打印技术的复杂设备。*科学：由世界上最大的插座设计、肢体形状和结果测量数据集提供支持——最初有1000个，部署后会增加。*商业：一个完全可互操作的系统，与任何数字形状捕获和制造方法兼容，可以授权并集成到全球的临床途径中。医疗保健方面的挑战相当大，英国国家医疗服务体系（NHS England）每年进行7000例截肢手术，成本负担为6000万英镑，而美国每年进行18.5万例截肢手术。随着人口老龄化和糖尿病发病率的上升，这一挑战日益严峻。Radii创新将通过以下方式应对医疗保健挑战并带来社会经济影响：*通过提供预测性人工智能模型，使义肢医生能够设计更好的适配插槽，释放数据潜力，以更快地实现完美适配。*减少适应时间。*降低废品率和降低改装成本。*每家诊所每年可节省约20万英镑。*改善患者预后和生活质量，改善舒适度，使患者能够充分参与社会活动。

Radii is motivated by the need to improve the fitting of prosthetic limbs for the 170m people worldwide with amputations. This is an urgent priority for patients: a well-fitting prosthetic socket is the determining factor in enabling mobility and participation in society; and for the clinic: with increasing demand for prosthetic limbs, increasing cost burden, and resulting need to support prosthetists to achieve perfect socket fit, faster, with fewer rejections.The prosthetic socket interfaces between the residual limb and the prosthetic componentry. However advanced the componentry, if the socket is the wrong shape or size, or the pressure distribution doesn't match the user's needs, the limb will be completely useless. These sockets are complex to design due to variability in patient limb shape, soft tissue stiffness and regional tolerance to load. Rejection rates are 31%.Since 2014, University of Southampton researchers have developed technology to meet the patient and clinic need, guided by input from providers including Opcare, and patients. Radii Devices are translating this technology to the clinic.This project will develop a revolutionary system to support prosthetists in the design of prosthetic sockets, supporting the complex rectification process with data and AI to enable better designs for perfect fit, faster, with fewer patient appointments.Innovations include:* Technical: the first solution to provide data-driven support in the socket design process, capable of designing complex devices which fully utilise cutting-edge 3D printing technologies.* Scientific: powered by the world's largest dataset of socket designs, limb shapes, and outcome measures -- initially 1000, increasing post-deployment.* Commercial: a fully interoperable system, compatible with any digital shape capture and manufacturing method, which can be licenced and integrated into clinical pathways worldwide.The healthcare challenge is sizeable, with 7,000 amputations performed annually by NHS England, with a £60m cost burden, and 185,000 amputations annually in the US. The challenge is growing with ageing populations and rising diabetes incidence.The Radii innovation will meet the healthcare challenge and offer socio-economic impact by:* Enabling prosthetists to design better fitting sockets by providing predictive AI models, unlocking the potential of data to support achievement of perfect fit, faster.* Reducing time to fit.* Reducing rejection rates and reducing costs of refits.* Offering savings of ~£200k/year per clinic.* Improving patient outcomes and quality of life, with improved comfort and enabling full participation in society.