I-Corps: Soft Robotics-Inspired Antifouling Urinary Catheters for Reducing Infection

大约五分之一的住院患者接受导尿管。仅在美国，每年使用的导尿管就超过3000万根，它们是医院相关感染的头号来源。这些感染不仅对病人来说是痛苦的，而且这些感染不包括在保险范围内，而且医院治疗费用昂贵。此外，治疗这些感染的必要性也导致了抗药性生物体的增加。这项突破性的导管技术是一种对抗感染的新方法，它可以按需“挤出”导管内生长的细菌（而不需要 影响导管的外部尺寸或患者舒适度）。这种机械方法是新的，避免了以前尝试的无效化学和生物方法的陷阱，并准备彻底改变长期停滞的导管市场。该技术利用了当前的材料和制造能力，这一点很重要，因为导尿管通常是低成本、大批量的产品。总的来说，证明这种新的生物膜导管在临床上是有效的，将降低家庭护理的总成本，并为患者、临床医生、医院、长期护理机构和保险机构的急性护理带来“巨大的胜利”。在美国，每年大约花费150亿美元来管理和去除生物膜。虽然在这个项目中的尿道外括约肌方法具有普遍的效用，但所提出的具体应用，尿道外括约肌导尿管，代表了一个特别重要的问题。这个I-Corps团队开发了一种抗生物膜技术，该技术使用导管壁中的膨胀弹性室（如软机器人机器的弹性室）来选择性地在导管的内（尿液携带）管腔上产生表面变形，以去除生物膜，从而减少感染。该团队计划在一项试点研究（由杜克库尔特转化项目资助）中使用基于硅胶的多腔导管原型开发临床可行性数据，以确定我们的导管技术的有效性，提高相关IP的价值，并向商业化迈进。该团队已经生成了令人信服的概念验证体外数据，证明大规模硅胶导管轴可以从导管内表面去除几乎所有的模型混合细菌群落生物膜。该团队也受到了导管患者和导管制造商的强烈兴趣。在I-Corps计划期间，客户访谈将使市场更好地了解定义优势，高影响力领域（例如，重症监护与长期护理）、特定导管类型（耻骨上导管与Foley导管），还允许团队评估该平台技术的其他潜在应用。该项目将有助于制定启动商业化计划以及与潜在的持牌导管制造商进行谈判。

Approximately 1 in 5 people who are hospitalized receive a urinary catheter. In the US alone, there are over 30 million urinary catheters used annually, and they are the #1 source of hospital-associated infections. Not only are these infections painful for the patient, the infections are not covered by insurance and are expensive for the hospital to remedy. Furthermore, the necessity to treat these infections has contributed to the rise of antibiotic-resistant organisms. The proposed ground-breaking, antifouling catheter technology is a new approach to battle infections that on-demand "squeezes" out bacteria that grow inside of the catheter (without affecting the external dimensions of the catheter or patient comfort). This mechanical approach is new, avoids the pitfalls of ineffective previously attempted chemical and biologic approaches, and is poised to revolutionize the long-stagnant catheter market. The technology takes advantage of current materials and manufacturing capabilities, which is important since urinary catheters are typically a low-cost, high-volume product. Overall, demonstrating that this new antifouling catheter is clinically effective would reduce the total cost of home care and be a "big win" for acute care of patients, clinicians, hospitals, long-term care facilities and insurance agencies.In the United States, approximately $15 billion are spent annually tomanage and remove biofilms. While the antifouling approach in this project has general utility, the proposed specific application, an antifouling urinary catheter, represents a particularly important problem to address. This I-Corps team has developed an anti-biofilm technology that uses inflating elastic chambers (like those of soft robotic machines) in the walls of the catheter to selectively generate surface deformation on the inner (urine-carrying) lumen of the catheter to remove biofilms and thereby reduce infection. The team plans to develop clinical feasibility data using silicone-based multi-lumen antifouling catheter prototypes in a pilot study (funded by the Duke Coulter Translational Program) to establish the efficacy of our catheter technology, enhance the value of the related IP, and advance towards commercialization. The team has already generated compelling proof-of-concept in vitro data demonstrating that to-scale silicone catheter shafts remove almost all of a model mixed-bacterial community biofilm from the interior surface of the catheter. This team has also received intense interest from catheterized patients as well as from catheter manufacturers. During the I-Corps program, customer interviews will allow a better market understanding of defining advantages, high impact areas (e.g., intensive care vs. long term care), specific catheter type(suprapubic vs. Foley catheters), and also allow the team to evaluate other potential applications for this platform technology. This project will aid in developing a startup commercialization plan as well as in negotiating with potential licensee catheter manufacturers.