SBIR Phase I: Localized and Sustained Antibiotic Delivery For Treatment of Periprosthetic Joint Infection (PJI) in Arthroplasty Patients

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响是开发一种创新的医疗技术，用于假体周围关节感染（PJI）的局部和持续抗生素治疗。拟议的活动可能导致植入物的商业化，该植入物具有新型储库技术，将被放置在感染部位，并将局部递送抗生素以根除感染。该解决方案可以改善患者护理以及降低与感染治疗相关的成本。开发一种可植入的、药物洗脱的矫形间隔器，使患者能够恢复非卧床状态，同时在持续时间内提供持续的、适当的抗感染抵抗力，这可能使患者受益并降低医疗成本。申报产品旨在减少感染，减少手术翻修和显著抗生素治疗的需求。如果成功，这项技术将减少与未解决的感染相关的负担，并避免截肢。该团队将设计，开发和验证骨科垫片的概念验证。该系统将使用能够控制抗生素洗脱的新型多孔介质进行3D打印。 将使用台架机械试验和植入系统活力和受控洗脱的体外研究对产品进行试验。目标包括研究原型的能力，以满足机械性能的设计标准，以及证明一个上级抗生素洗脱曲线超过延长释放期。要执行的机械测试包括当前标准范围内的负载、应力和循环测试，以及在持续时间（长达180天）内对指定抗生素物质进行的体外实验室洗脱测试。该奖项反映了NSF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 of this Small Business Innovation Research (SBIR) Phase I project is develop an innovative medical technology for localized and sustained antibiotic treatment in the case of periprosthetic joint infection (PJI). The proposed activities may result in commercialization of an implant with novel reservoir technology to be placed at the infected site, and which will locally deliver antibiotics to eradicate the infection. This solution may improve patient care as well as reduce costs associated with treatment of infection. The development of an implantable, antibiotic-eluting orthopedic spacer which enables patients to return to ambulatory conditions while providing sustained, appropriate, anti-infection resistance for a sustained duration could benefit patients and reduce medical costs. The proposed product seeks to reduce infections and reduce the need for surgical revision and significant antibiotic treatments. If successful, this technology will reduce the burden associated with unresolved infections and avoid amputations.This team will design, develop, and validate the proof of concept for an orthopedic spacer. The system will be 3-D printed using a novel porous medium capable of controlled antibiotic elution. The product will be tested using benchtop mechanical testing and in vitro studies of implanted system viability and controlled elution. The objectives include a study of the prototype's ability to meet design criteria for mechanical performance, as well as a demonstration of a superior antibiotic elution profile over an extended-release period. The mechanical testing to be performed include load, stress, and cycle testing within current standards, in conjunction with in vitro laboratory elution testing of the specified antibiotic substance over a sustained duration of time (up to 180 days).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.