Abstract
Current high-performance prosthetic feet work well for many users, but the low resolution of size and stiffness categories may limit walking performance for certain users. A line of prosthetic feet with a high resolution of sizes and stiffnesses, designed through amputee-specific personalization, could provide clinical and economic value. The lower leg trajectory error (LLTE) design framework facilitates the design of high-performance, amputee-specific prosthetic feet; however, previous foot prototypes were not designed to satisfy the economic, mechanical, and aesthetic requirements for commercial adoption. The aims of this work were to understand how a personalized, affordable prosthetic foot can align with the clinical-commercial ecosystem, innovate a viable future product, and inform other prosthesis designers of considerations required to connect innovation to real-world implementation. We evaluated needs by identifying how products, capital, and services flow between stakeholders, and we elucidated design requirements for a personalized prosthetic foot that can be manufactured, distributed, and clinically provided. Based on material properties and manufacturing process capabilities, computer numerically controlled (CNC) machining of Nylon 6/6 satisfies these requirements. We present a novel parametric foot architecture that can be CNC machined, fits within a commercial foot shell, and can be designed for individual users’ body characteristics and activity levels. Prototypes made using the new foot design behaved as anticipated (1–12% error in modeled displacement), satisfied industry-standard strength (ISO 10328) and mechanical performance (AOPA dynamic heel/keel) requirements, and elicited positive feedback from both amputees and prosthetists.
Issue Section:
Design Innovation Paper
Keywords:
compliant mechanisms,
design automation,
design for manufacturing,
design of innovative devices,
design of machine elements,
design optimization,
design validation,
multidisciplinary design and optimization,
product design,
product family design,
structural optimization,
topology optimization,
user-centered design
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