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

该PFI项目更广泛的影响/商业潜力包括建立微纹理医用气球设计所需的关键知识体系，以进一步促进美国公众的健康。胃肠道疾病每年影响估计6000万至7000万美国人，估计有400万至500万住院治疗、7000万门诊护理就诊和超过20万例可归因于胃肠道疾病的死亡。据估计，美国每年用于胃肠道疾病的直接和间接费用超过1400亿美元。在美国，每年进行超过1800万次胃肠内窥镜检查，门诊胃肠内窥镜检查的总费用超过320亿美元。 本提案的目的是评估一种新型微毛面球囊设计，以改善内窥镜检查结果。该研究项目还将通过在创新、客户发现、市场评估、知识产权保护、技术翻译、业务开发和商业化方面培训研究生和本科生，提高美国的经济竞争力。学术界和工业界之间的伙伴关系将通过与制造业的合作来加强，以寻求新的挤出微织构方法，并将行业标准和材料加工知识带回课堂。拟议的项目将通过制定大规模制造微纹理所需的初步技术，实现内窥镜球囊的微纹理化。本项目还将证明与传统内窥镜检查方法相比，原型微毛面球囊在实验室和体内的性能。与当前的球囊内窥镜检查相比，使用微纹理球囊进行内窥镜检查将节省时间、节省资金并改善患者结局。微纹理球囊显著增加摩擦和球囊锚定，从而允许更有效地使用球囊内窥镜技术。拟议研究的目标是双重的。首先，通过将实验室试验与体内动物手术试验相结合的分层方法评价微毛面球囊的有效性。其次，将在实验室和与行业合作伙伴密切合作的情况下，探索具有成本效益的新型制造方法。本研究的智力价值在于：1）实验测量微纹理球囊的锚固力作为球囊几何形状和微纹理几何形状的函数，2）定量测量与传统内窥镜检查方法相比的体内有效性，以及3）使创新的制造方法能够实现微该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.