A DRUG RELEASING URINARY CATHETER

导尿管相关性尿路感染（CANTI）是医院内最常见的院内感染，是一个重要的问题。本项目的目的是制造和评价一种由硅橡胶材料制成的新型含药导尿管，该材料载有抗菌剂葡萄糖酸氯己定（CHG）。该材料先前已被证明对通常遇到的微生物有效。CHG包含在聚乙二醇基质中，均匀分散在弹性体中，并设计为在长达4周的时间内释放药物。选择CHG作为抗菌剂是基于其广谱活性、细菌对其作用产生耐药性的发生率低以及其相对低的毒性。含1%、2%、3%和4% CHG（按重量计）的导管将通过压缩成型以及注射成型的改良形式制造。将使用高效液相色谱法在体外对4周内导管中CHG的释放进行定量。然后在成年家兔动物模型中评价每种候选制剂的供试品作为粘膜刺激物的潜力，持续7天接触。这种含药导管系统的目的是抑制或防止在管腔或面向导管表面的组织上形成生物膜，这种情况使得EPTI非常难以治疗。在生物膜形成后，需要500- 5，000倍于杀死相同物种的自由漂浮生物体所需的抗生素浓度。拟议的商业应用：有效抑制细菌生长的导尿管有可能显著改善对接受各种外科手术的患者的护理。新的导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.