SBIR Phase I: Novel Peritoneal Dialysis Catheter to Reduce Infections

该小型企业创新研究（SBIR）I期项目的重点是为腹膜透析患者开发一种不依赖患者依从性的创新导管设计。目前，50%的PD患者（平均）在前18个月内发生腹膜炎。在随后的几个月里，感染的风险迅速增加。腹膜炎的治疗包括长期抗生素治疗，这会导致多种副作用，并且并不总是根除感染。每年，大约25-50%的PD患者由于感染并发症而被迫转为HD。 这些并发症可能涉及导管移除，平均每次感染发作的费用为20，000美元，每年医疗保健系统的费用约为2亿美元。由于感染风险和当前灭菌方案的复杂性，更多的患者从未在第一时间进行PD。这种创新导管的预期结果是感染风险降低约50%。该项目的更广泛影响/商业潜力解决了与透析相关的感染挑战。这些年龄组的慢性肾病发病率增长超过7%。 在美国，每年有近40万患者接受透析治疗。全球腹膜透析市场超过20亿美元。此外，PD已被证明可以降低高达27%的死亡风险，提高生活质量，降低约25%的成本。通过减少腹膜炎的发生率并减少当前灭菌方案所涉及的时间、复杂性和培训，我们的解决方案将改变透析范式，使更广泛的患者群体能够享受腹膜透析所能提供的大幅改善的生活质量。此外，更清楚地了解与导管相关菌血症相关的感染将有助于找到解决方案，以减少其他导管相关病例（包括导尿管，IV导管和PICC管路）感染导致的住院治疗。 与导管相关的感染仍然是一个主要的全球性问题，该解决方案可以节省超过350亿美元的导管相关菌血症成本。

This Small Business Innovation Research (SBIR) Phase I project is focused on developing an innovative catheter design for peritoneal dialysis patients that is not reliant on patient compliance. Currently, 50% of PD patients (on average) experience peritonitis within the first 18 months. The risk of infection rapidly multiplies in subsequent months. Treatment for peritonitis includes long-term antibiotic treatment that causes multiple side effects and does not always eradicate the infection. Every year, roughly 25-50% of PD patients are forced to switch to HD as a result of complications from infections. Such complications can involve catheter removal, which costs at an average of $20,000 per infection episode, and ~$200Million annual cost to the healthcare system. Many more patients are never administered PD in the first instance because of risk from infection and the complexity involved with current sterilization protocol. Anticipated results with this innovative catheter are around 50% decrease in infection risk. The broader impact/commercial potential of this project addresses the challenge of infection related to dialysis. Chronic Kidney Disease incidence is growing at over 7% for these age groups. In the US, nearly 400,000 patients receive dialysis treatment every year. The global market for peritoneal dialysis exceeds $2Billion. Moreover, PD has proven to show up to 27% lower mortality risk and enhanced quality of life, at ~25% lower cost. By reducing the incidence of peritonitis and by decreasing the time, complexity, and training involved in the current sterilization protocol, our solution will transform the dialysis paradigm, enabling a much broader group of patients to enjoy the substantially improved quality of life that PD can provide. Moreover, a more clear understanding of infections related to catheter-related bacteremia will help find solutions to lessen hospitalizations resulted from infection in other catheter-related cases as well (including urinary, IV catheters, and PICC lines). Infections related to catheters are still a major global problem and this solution can save more than $35 Billion in catheter-related bacteremia costs.