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

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力将帮助患有关节感染的全膝关节置换术患者。假体周围关节感染（PJI）是全关节置换术中可能危及生命的细菌感染。除了立即治疗之外，若干年后不相关的损伤可能会引起感染，随着老年患者选择更换关节，PJI的发病率会增加。目前，美国大约有1560万人使用人工关节置换，如果不改进治疗方法，到2023年，PJI将代表美国每年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，这是已知的持续感染的原因。该项目将推进一种专有的植入式药物输送系统，该系统可以轻松地在关节中产生和维持足够的抗生素浓度，以消除生物膜并解决感染，同时减少手术创伤，使患者更容易康复，降低医疗成本，而不是目前的标准护理提供。这个小型企业创新研究（SBIR）二期项目将推进一种新型植入式药物输送系统的翻译，该系统带有一个外部穿戴式控制器，通过皮肤与一个由泵和储液器组成的简单植入物通信。当治疗完成后，泵可以留在原位，不需要移除它，避免了目前植入泵技术常见的额外手术。该项目推进了植入物和控制器的开发，以生成彻底测试的原型，包括在模拟环境中对生物膜根除的功效评估。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/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.