SBIR Phase II: Antibiotic-Dispensing Spacer for Improved Periprosthetic Joint Infection (PJI) Treatment

这一小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力将帮助患有关节感染的全部膝关节置换患者。假体周围关节感染(PJI)是全关节置换术中一种潜在的危及生命的细菌感染。除了立即治疗外，感染可能会在几年后因无关的损伤而发展，随着老年患者选择关节置换，PJI的发生率会增加。目前，美国约有1560万人使用关节置换术，如果不改善治疗，到2023年，PJI将每年给美国带来22亿美元的医疗负担。目前的护理治疗标准不能在足够的时间内在关节内产生足够高的抗生素浓度，以根除植入物和组织上的细菌生物膜，这是持续性感染的已知原因。该项目将推进一种专有的植入性药物输送系统，以轻松地在关节内产生和维持足以根除生物被膜和解决感染的抗生素浓度，并且比目前的护理机构标准更少的手术创伤、更容易的患者康复和更低的医疗成本。这一小型企业创新研究(SBIR)第二阶段项目将推进一种新型的植入性药物输送系统的转化，该系统带有一个外部穿戴的控制器，通过皮肤进行通信，成为由泵和储液器组成的简单植入物。当治疗完成后，泵可以保留在适当的位置，而不需要移除它，避免了当前植入式泵技术常见的额外手术。该项目推动了植入物和控制器的开发，以生成用于彻底测试的原型，包括在模拟环境中对生物膜根除的有效性评估。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/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will help total knee replacement patients who have a joint infection. Periprosthetic Joint Infection (PJI) is a potentially life-threatening bacterial infection of a total joint replacement. Beyond immediate treatment, infections can develop years later from unrelated injuries, increasing PJI incidence as older patients opt for replacement joints. Roughly 15.6 million people in the US currently use a replacement joint, and without improved treatment, PJI will represent an estimated $2.2 billion annual US healthcare burden by 2023. The current standard of care treatment cannot generate sufficiently high antibiotic concentrations within the joint over enough time to eradicate bacterial biofilms on the implant and tissue, the known cause of persistent infection. This project will advance a proprietary implantable drug delivery system to easily generate and maintain an antibiotic concentration in the joint sufficient to eradicate biofilm and resolve an infection with less surgical trauma, easier patient recovery and lower healthcare cost than the current standard of care provides.This Small Business Innovation Research (SBIR) Phase II project will advance translation of a novel implantable drug delivery system with an externally worn controller that communicates through skin to a simple implant comprising a pump and reservoir. When therapy is complete the pump can be left in place with no requirement to remove it, avoiding additional surgery common with current implantable pump technology. This project advances the development of the implant and controller to generate prototypes for thorough testing, including efficacy evaluation for biofilm eradication within a simulated environment.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.