Development of a Dynamic Tensioning Ankle Brace for Chronic Ankle Instability; Patent Systems as Socially Constructed Apparatuses that Influence Large Technological Systems: A Comparison of the United States and Chinese Patent Systems

Patent systems are socially-constructed and, in part, control social progress. Through the development of a dynamic tensioning ankle brace for chronic ankle instability (CAI) and the analysis of the U.S. and Chinese patent systems during COVID-19, I have seen first-hand how patent systems shape future innovation.

CAI is a common ankle condition resulting from repeated ankle sprains, foot posture abnormalities, and ankle misalignment. Despite high incidence rates of CAI, a user-centered design that offers sufficient ankle joint force unloading and stability did not exist. My Biomedical Engineering Capstone team identified this need and set off to find a solution. Over the academic year, our success was defined by the creation and execution of a development plan outlined around our project aims. This plan included clinical research, market research, intellectual property (IP) research, insurance code research, survey collection, creation of a design specification matrix, material sourcing, in-house testing, Institutional Review Board (IRB) submission, preliminary patent application submission, and an iterative design process that led to five prototype braces. Using Icarus Medical Innovations’ array of patented technology, my team and I created a 3D scan-to-fit brace capable of providing adjustable stability in the sagittal, frontal, and transverse planes. Our brace was designed to qualify for the L-1904 insurance code to ensure an affordable, accessible solution.

The U.S. and Chinese patent systems are vastly different and represent their country’s distinct social values. Throughout the COVID-19 pandemic, flaws in our patent systems were highlighted as we sought rapid, worldwide distribution of vaccines, personal protective equipment, and other life-saving technologies. To give context to patent systems as socially-constructed apparatuses, I analyzed cultural differences illustrated by the Twenty Statements Test and the development of patent systems before COVID-19, including differences in patent infringement processes, compulsory licensing, and requirements for patentability in the U.S. and China. After establishing a clear background of these countries’ patent systems, I began to see how these differences provided a ripple effect that led to differences in innovation and distribution during the COVID-19 pandemic. Through the close examination of this case study, I better understand how we can use our patent systems and related large technological systems as a force for social equity in healthcare.

As my peers and I transition into our engineering-related careers, we must reflect on our goals at an individual and community level as our work will undoubtedly shape future innovation and societies. By analyzing the impact of patent systems and exploring my engineering role through the lens of Science and Technology in Society, I let non-technical aspects influence my Capstone ankle brace design to be user-centered and empathetic.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Timothy Allen
STS Advisor: Sean Ferguson
Technical Team Members: Andrew Quigley, Benjamin Scire, & Evan Wendell