A DRUG RELEASING URINARY CATHETER

导尿管相关性尿路感染（CAUTI）仍然是一个重要的问题，是医院获得性最常见的医院感染。本项目的目的是制造和评估一种新型药物导尿管，该导尿管由硅橡胶材料制成，该材料装载了抗菌药物葡萄糖酸氯己定（CHG）。这种材料先前已被证明对通常遇到的CAUTI生物有效。CHG包含在聚乙二醇基质中，均匀分散在弹性体中，并设计在长达4周的时间内释放药物。选择CHG作为抗菌药物是基于其广谱活性、细菌对其作用产生耐药性的低发生率以及相对较低的毒性。含有1%、2%、3%和4% CHG（按重量计）的导管将通过压缩成型和改良形式的注射成型制造。在体外用高效液相色谱法测定4周内导管中CHG的释放量。然后对每种候选制剂的测试标本进行7天接触期成年兔动物模型中作为粘膜刺激物的潜力评估。这种药物导管系统的目的是抑制或防止在管腔或导管表面组织上形成生物膜，这种情况使得CAUTI非常难以治疗。在生物膜形成之后，需要的抗生素浓度为杀死同一物种的自由漂浮生物所需浓度的500- 5000倍。建议的商业应用：一种有效抑制细菌生长的导尿管有可能显著改善接受各种外科手术的患者的护理。新型导尿管有可能降低与导尿管相关感染管理相关的医院费用。

Catheter associated urinary tract infection (CAUTI) remains a significant problem, being the most common nosocomial infection acquired in hospitals. The goal of this program is the fabrication and evaluation of a new medicated urinary catheter manufactured from a silicone rubber material which is loaded with the antimicrobial agent chlorhexidine gluconate (CHG). This material has previously been shown to be effective against organisms typically encountered with CAUTI. The CHG is contained in a polyethylene glycol matrix uniformly dispersed in the elastomer and designed to release the drug over a period of up to 4 weeks. The choice of CHG as the antimicrobial agent is based on its broad spectrum activity, low incidence of the development of bacterial resistance to its action, and its comparatively low toxicity. Catheters with 1%, 2%, 3%, and 4% CHG by weight will be fabricated by compression molding and also by a modified form of injection molding. The release of CHG from the catheters will be quantitated in vitro over a 4 week period using high performance liquid chromatography. Test specimens of each candidate formulation will then be evaluated for their potential as mucosal irritants in an adult rabbit animal model for a 7 day period of contact. The aim of this medicated catheter system is to inhibit or prevent biofilm formation on either the luminal or tissue facing catheter surfaces, a situation which makes CAUTI very difficult to treat. Following biofilm formation, antibiotic concentrations ranging from 500-5,000 times that required to kill free floating organisms of the same species are needed. PROPOSED COMMERCIAL APPLICATIONS: A urinary catheter that effectively inhibits bacterial growth has the potential to significantly improve care for patients undergoing a wide variety of surgical procedures. The new urinary catheter has the potential to reduce hospital costs associated with the management of catheter associated infections.