PFI-TT: Micro-Structured Balloon Surfaces for More Effective Endoscopy

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The broader impact/commercial potential of this PFI project includes establishing a crucial body of knowledge needed for the design of micro-textured medical balloons, to further advance the health of the American public. Gastrointestinal diseases affect an estimated 60-70 million Americans annually, with an estimated 4-5 million hospitalizations, 70 million ambulatory care visits and over 200,000 deaths attributable to gastrointestinal disease. Spending on gastrointestinal diseases in the U.S. has been estimated at over $140 billion per year in direct and indirect costs. There are over 18 million gastrointestinal endoscopies performed annually in the U.S. with a total cost for outpatient gastrointestinal endoscopy of over $32B. The objective of this proposal is an assessment of a novel micro-textured balloon design to improve endoscopy outcomes. The research project will also increase the economic competitiveness of the United States by training graduate and undergraduate students in innovation, customer discovery, market assessment, intellectual property protection, technology translation, business development and commercialization. Partnerships between academia and industry will be strengthened through collaboration with manufacturing industry in pursuit of novel extrusion micro-texturing methods, and bringing industry standards and materials processing knowledge back to the classroom. The proposed project will enable micro-texturing of endoscopy balloons by formulating the preliminary techniques required to manufacture micro-textured at scale. This project will also demonstrate prototype micro-textured balloon performance on the benchtop and in vivo as compared to conventional endoscopy methods. Endoscopy performed with micro-textured balloons will save time, save money, and improve patient outcomes compared to current balloon endoscopy. Micro-texturing balloons dramatically increases friction and balloon anchoring, thereby allowing more effective use balloon endoscope technologies. The goals of the proposed research are two-fold. First, evaluating efficacy of the micro-textured balloons through a tiered approach coupling benchtop testing with in vivo animal procedure testing. Second, novel manufacturing methods for cost-effective fabrication will be explored, both in the laboratory and by working closely with industry partners. The intellectual merit of this research lies in 1) experimentally measuring the anchoring forces of micro-textured balloons as a function of balloon geometries and micro-texture geometries, 2) quantitatively measuring the effectiveness in vivo as compared to conventional endoscopy methods, and 3) enabling innovative manufacturing methods to micro-texture extruded materials.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.