A safer urinary catheter design to reduce catheter trauma and infections

更安全的导尿管设计，减少导管创伤和感染

• 批准号: 8525483
• 负责人: Buzzy Bonneau
• 金额: $ 14.7万
• 依托单位: SAFE MEDICAL DESIGN, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8525483
• 关键词: Address; Adverse event; Age; Animal Model; Applications Grants; Area; Bladder; Cadaver; Calibration; Caring; Catheterization; Catheters; Clinical Trials; Consultations; Data; Databases; Development; Devices; Disease; Economic Inflation; Face; Family suidae; Federal Government; Future; Gender; Goals; Guidelines; Harvest; Health Care Costs; Healthcare Industry; Healthcare Systems; Hemorrhage; Histologic; Hospital Nursing; Hospitals; Human; Incidence; Infection; Injury; Inpatients; Intellectual Property; Intervention; Legal patent; Length of Stay; Licensing; Manufacturer Name; Marketing; Measurement; Measures; Medical; Medical Device; Methodology; Minor; Modification; Morbidity - disease rate; Needles; Needlestick Injuries; Nurses; Outcome; Pain; Patients; Performance; Phase; Physicians; Prevention; Price; Process; Recurrence; Reporting; Research; Risk; Safety; Sampling; Series; Severities; Small Business Innovation Research Grant; Specimen; Structure; Syringes; System; Techniques; Testing; Training; Trauma; Urethra; Urethral Catheterization; Urethral Stricture; Urine; Urologist; Urology; Work; Wound Healing; base; catheter associated UTI; cost; design; experience; health care service utilization; human subject; improved; indexing; injured; interest; manufacturing process; manufacturing scale-up; medical specialties; member; men; patient safety; pressure; prevent; prototype; public health relevance; success; urinary; urologic

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.

描述(申请人提供)：在当今的设备世界，产品必须在质量和安全审查日益严格的情况下解决医疗成本飙升的问题。通过解决患者安全问题，我们相信可以降低成本，提高质量。非感染性导尿管相关并发症是美国和世界卫生保健行业面临的此类患者安全问题之一。近20%的美国住院患者-近800万患者-放置了导尿管。从2006年到2008年，我们利用联邦政府的医疗成本和利用项目数据库确定了近110,000例与导尿管相关的损伤。(1)这些损伤及其相关的短期和长期并发症给患者带来了严重的发病率，并给医疗保健系统带来了负担。导尿管有一个机制，可以充气膀胱内的滞留气球和一个流出端口，让尿液外泄。当保留气囊在狭窄的尿道腔内充气时，可能会对患者造成很大的损害。这种医源性损伤的确切发生率还不是很清楚，因为文献记载很少。在美国，每年有近400万男性住院接受导尿术。根据国家住院患者样本中具有全国代表性的管理数据，我们估计，在这些患者中，大约每500人中就有1人因导尿而遭受尿路损伤(2)。目前治疗这些不良事件的成本约为每个患者2888美元。我们的团队在加州大学旧金山分校对人体身体进行的研究(3)，导致了一种更安全的导尿管设计的专利申请，该设计获得了我们公司的许可。由于今天的导尿管是一种商品化产品，只有在符合当前报销指南的定价结构下，更安全的导尿管系统才有可能在商业上取得成功。我们认为，通过对现有导尿管设计进行简单的调整，可以大大减少导尿管相关的损伤，而几乎不需要额外的成本。这项建议的目的是：(1)确定激活我们的设备以减轻尿路损伤的阈值压力，并通知最终用户错误的导尿管放置；(2)基于我们获得许可的知识产权，设计一种成本相当、更安全的导尿管原型；(3)在体外和动物模型中测试这些原型，以进一步磨练我们导尿管设计的参数，并初步展示其有效性的概念证明。