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

这个i-Corps项目的更广泛影响是开发了一种新的医用聚合物，具有独特和罕见的弹性耐用性和凝胶状润滑性能的组合。这些新型水凝胶弹性体有可能在美国医疗保健和医疗器械行业产生广泛影响。它们既是一种低摩擦、耐用的结构设计材料，也是一种生物惰性表面涂层替代品，使其在各种新的和现有的医疗设备技术中具有重要意义。为了避免对环境有害的全氟烷基物质(PFAS)物质，对新的、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新出现的空白方面处于有利地位。潜在的更广泛的影响可以扩展到新的工具，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导管。这个i-Corps项目利用经验学习和对行业生态系统的第一手调查来评估技术的翻译潜力。该解决方案基于热塑性弹性体(TPE)水凝胶的开发，该水凝胶具有必要的耐用性、弹性、耐磨性、生物稳定性和生物兼容性，可作为医疗器械设计中的结构材料。这些材料在一系列材料硬度计上表现出固有的表面润滑性，同时保持全氟烷基物质(PFAS)和不含氟聚合物。热塑性弹性体是广泛的医疗器械的关键部件，但在暴露表面需要低摩擦润滑性，以最大限度地减少与生物组织的相互作用。现有的热塑性弹性体材料缺乏这种润滑性，生物医疗设备的设计者被迫依赖昂贵和复杂的亲水表面处理，或者使用疏水、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激活的倾向，已被吹捧为此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首批能够满足大多数产品应用中所需耐用性要求的技术之一。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.