A DRUG RELEASING URINARY CATHETER

导管相关性尿路感染(CAUTI)仍然是一个重要的问题，是医院获得的最常见的医院感染。该项目的目标是制造和评价一种由硅橡胶材料制成的新型药物尿管，该材料含有抗菌剂葡萄糖酸氯己定(CHG)。这种材料以前已被证明对CAUTI通常遇到的生物体有效。CHG包含在均匀分散在弹性体中的聚乙二醇骨架中，并设计用于在长达4周的时间内释放药物。选择CHG作为抗菌剂是基于其广谱的活性、较低的细菌耐药性发生率和相对较低的毒性。重量分别为1%、2%、3%和4%CHG的导管将通过压缩模塑和一种改进的注射模塑形式制造。导管中CHG的释放量将在4周内用高效液相色谱定量。然后，将评估每种候选制剂的测试样品在成年兔动物模型中作为粘膜刺激物的可能性，并进行7天的接触。这种药物导管系统的目的是抑制或防止面对导管表面的管腔或组织上生物膜的形成，这种情况使CAUTI非常难以治疗。在生物膜形成后，需要500-5000倍的抗生素浓度来杀死相同物种的自由漂浮生物。拟议的商业应用：一种有效抑制细菌生长的导尿管有可能显著改善对正在接受各种外科手术的患者的护理。这种新的尿管有可能降低与导管相关感染管理相关的医院成本。

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.