I-Corps: Translation Potential of an Elastomeric Low-Friction Fluoropolymer Alternative for the Medical Device Industry

I-Corps项目的广泛影响是开发一种新型医用聚合物，这种聚合物具有独特而罕见的弹性耐久性和凝胶状润滑性能的结合。这些新的水凝胶弹性体在美国医疗保健和医疗器械行业具有广泛影响的潜力。它们作为一种低摩擦、耐用的结构设计材料和生物惰性表面涂层替代品的效用，使它们与广泛的新型和现有医疗设备技术相关。为了避免对环境有害的全氟烷基物质（PFAS），对新型、低摩擦、耐用的聚合物替代品的需求变得更加迫切。这项技术在填补生物医学材料领域的新兴空白方面处于领先地位。潜在的更广泛影响可以扩展到新工具，从复杂的手术器械和植入技术到简单的伤口护理敷料和医用管。这个I-Corps项目利用体验式学习和对行业生态系统的第一手调查来评估该技术的翻译潜力。该解决方案基于热塑性弹性体（TPE）水凝胶的开发，这些水凝胶具有必要的耐久性、弹性、耐磨性、生物稳定性和生物相容性，可被视为医疗器械设计中的结构材料。这些材料被设计成在材料硬度范围内表现出固有的表面润滑性，同时保持无全氟烷基物质（PFAS）和含氟聚合物。TPEs是广泛医疗设备中的关键部件，但迫切需要在暴露表面具有低摩擦润滑，以最大限度地减少与生物组织的相互作用。现有的TPE材料缺乏这种润滑性，生物医学设备设计人员被迫依赖昂贵而复杂的亲水表面处理或使用疏水、含氟聚合物衬里或树脂涂层来实现低表面摩擦和生物表面钝化。基于水凝胶的材料，由于其固有的润滑性和抑制生物活性的倾向，已经被吹捧为这类设备的可能参与者，该项目探索的水凝胶材料技术将是市场上第一个能够满足大多数产品应用中耐久性要求的材料之一。该奖项反映了美国国家科学基金会的法定使命，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 of this I-Corps project is the development of a new medical polymer possessing a unique and rare combination of elastic-like durability and gel-like lubrication properties. These new hydrogel elastomers have the potential for broad impact across the U.S. healthcare and medical device industries. Their utility as both a low-friction, durable structural design material and as a bio-inert surface coating alternative makes them relevant in a wide range of new and existing medical device technologies. To avoid environmentally damaging perfluoroalkyl substances (PFAS) substances, the need for new, low friction, durable polymer alternatives has become more acute. This technology is in a prime position to fill an emerging void in the biomedical materials landscape. The potential broader impact can be extended to new tools, ranging from complex surgical instruments and implant technologies to simple wound care dressings and medical tubing.This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. The solution is based on the development of thermoplastic elastomer (TPE) hydrogels possessing the necessary durability, elasticity, wear resistance, biostability, and biocompatibility to be considered as structural materials in medical device design. These materials were engineered to exhibit intrinsic surface lubricity at a range of material durometers while remaining perfluoroalkyl substance- (PFAS) and fluoropolymer-free. TPEs are key components in a broad range of medical devices, but there is a critical need for low friction lubricity at the exposed surface to minimize interactions with biological tissues. Existing TPE materials lack such lubricity, and biomedical device designers are forced to depend on expensive and complex hydrophilic surface treatments or on the use of hydrophobic, fluoropolymer liners or resin coatings to achieve low surface friction and biological surface passivation. Hydrogel based materials, with their intrinsic lubricity and tendency to suppress bioactivation, have been touted as possible players in such devices, and the hydrogel material technology this project explores would be one of the first on the market that can meet the durability demands required in most product applications.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.