A safer urinary catheter design to reduce catheter trauma and infections

描述（由申请人提供）：在当今的器械世界中，产品必须在对质量和安全的日益严格的审查下解决飙升的医疗保健成本。通过解决患者安全问题，我们相信可以降低成本并提高质量。非感染性导尿管相关并发症是美国和全球医疗保健行业面临的一个患者安全问题。尿道导管被放置在近20%的美国住院患者中-近800万患者。从2006年到2008年，我们使用联邦政府的医疗保健成本和利用项目数据库确定了近110，000例尿道导管相关损伤。(1)这些损伤和相关的短期和长期并发症对患者造成严重的发病率，并给医疗保健系统带来负担。导尿管具有使膀胱内的留置球囊膨胀的机制和允许尿液逸出的流出端口。当固位气囊在尿道的狭窄管腔内膨胀时，会对患者造成很大的伤害。这种医源性损伤的确切发生率并不确切，因为它是缺乏记录。在美国，每年有近400万男性住院接受导尿术。在这些患者中，我们估计大约每500人中就有1人因导尿术而遭受尿道损伤，这是基于来自全国住院患者样本的全国代表性行政数据（2）。目前治疗这些不良事件的费用约为每位患者2888美元。我们的团队在UCSF进行的人类尸体研究（3）导致了一种更安全的导尿管设计的专利申请，该设计由我们公司授权。由于今天的导尿管是一种商品化的产品，一个更安全的导尿管系统的商业成功是唯一可能的定价结构，符合目前的报销准则。我们相信，导尿管相关的伤害可以大大减少通过简单的适应现有的导尿管设计，很少或没有额外的成本。本提案的目的是：（1）确定阈值压力，在该阈值压力下，我们的器械将被激活以减轻尿道损伤，并通知终端用户导管放置不正确（2）基于我们的许可知识产权，制作成本相当的更安全的导尿管原型;（三）在体外和动物模型中测试这些原型，以进一步完善我们的导管设计参数，并初步证明概念验证他们的功效。

DESCRIPTION (provided by applicant): In today's device world, products must address soaring healthcare costs under the increased scrutiny of quality and safety. By addressing patient safety, we believe costs can be reduced and quality improved. Non-infectious urethral catheter related complications are one such patient safety problem the US and worldwide health care industry faces. Urethral catheters are placed in nearly 20% of U.S. hospitalized patients- nearly 8 million patients. From 2006 to 2008 we identified nearly 110,000 urethral catheter-related injuries using the Federal Government's Healthcare Cost and Utilization Project database.(1) These injuries and the associated short and long-term complications pose significant morbidity to patients, and burden to the healthcare systems. Urinary catheters have a mechanism to inflate a retention balloon within the bladder and an outflow port to allow urine to escape. When the retention balloon is inflated within the narrow lumen of the urethra a great deal of damage can be done to the patient. The exact incidence of this type of iatrogenic injury is not precisely known because it is poorly documented. Nearly 4 million men hospitalized per year in the U.S. undergo urethral catheterization. Of those patients we estimated that around 1 in 500 suffer urethral trauma due to catheterization based upon nationally representative administrative data from the National Inpatient Sample(2). The current cost for treating these adverse events is approximately $2888 per patient. Research at UCSF conducted by our group on human cadavers (3), resulted in patent application for a safer urethral catheter design, which was licensed by our company. Because urinary catheters today are a commoditized product, the commercial success of a safer catheter system is only possible with a pricing structure that fits within the current reimbursement guidelines. We believe that urethral catheter-related injuries can be greatly reduced by simple adaptations to the existing urinary catheter design with little to no additional cost. The aims of this proposal are to: (1) identify the threshold pressureat which our device will be activated to mitigate urethral damage and notify the end-user of incorrect catheter placement (2) prototype a cost equivalent safer urethral catheter based upon our licensed intellectual property; (3) test these prototypes in ex vivo and animal models to further hone the parameters of our catheter designs and preliminarily demonstrate proof of concept of their efficacy.