SBIR Phase I: Universally-Adjustable Modular Prosthesis Socket

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to create a universally adjustable, semi-flexible modular socket system that adapts to fluctuations in limb volume and shape changes while providing a secure and comfortable fit. The modular design enables the product to be assembled, configured, and reconfigured to suit the specific limb shape of the patient. The system represents an alternative to current prosthetic limbs utilizing more expensive materials and equipment, and requiring hours of custom fitting. The system us proposed for fitting during a single office visit rather than over the course of several weeks and iterations, and without the expense of sending the designs to a composites manufacturing house. The system is suitable for various limb shapes, for both upper and lower limb sockets, and growing patients. The broader impact is a simpler modular system that will reduce fitting time by 2/3rds with a single visit, to represent a novel standard of care for the $2.7B annual US prosthetics market. This Small Business Innovation Research (SBIR) Phase I project proposes to develop a novel prosthesis that utilizes discrete mass-producible modular components to create fitted adjustable sockets. The system is components are fabricated in preassembled sheets using selective laser sintering to create a system with comparable manufacturing characteristics as injection molding. The modules can be assembled configurations and provide a mechanism for conforming to the shape of the individual’s residual limb. The system enables quickly replacing broken components and socket modifications to long-term changes in limb shape. This accomodates minor adaptive changes, dimensional changes typically observed with a growing child, or complete rebuilds using the same components. During Phase I, expandable, modular prototypes integrated into a durable harnessing system will be developed and furthered, particularly in the context of coupling a semi-flexible socket system to soft tissues. The completed systems will then be characterized and validatated including maximum and minimum pressure and hotspot mapping under physiologically simulations of loading and torque observed during routine daily use. The results will provide the necessary confines for a validated design and specifications for human use at a future phase. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.