STERILE DOCKING DEVICE FOR CENTRAL VENOUS CATHETER HUBS

用于中心静脉导管接头的无菌对接装置

• 批准号: 6141313
• 负责人: KENNETH L CARR
• 金额: $ 9.08万
• 依托单位: MICROWAVE MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-15 至 2000-12-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6141313
• 关键词: antisepsis; antiseptic sterilization; biomaterial development /preparation; biomedical equipment development; catheterization; microwave radiation; parenteral feedings; temperature

The proposed device is designed to sterilize tunneled central venous catheter hubs used for patients receiving total parenteral nutrition. Such a device is needed to decrease infectious complications associated with the use of these catheters which is related to repeated accessing of the hub. Although the basic idea of using microwave energy to steam sterilize a hub connection might appear somewhat obvious and simple, the technical challenges to design and construct a successful device are many. The heating cavity must be small and lightweight since it will be positioned close to the patient. It must be able to recognize small (<0.1ml) air bubbles in a saline environment. It is hoped that this can be achieved by reflection coefficient determination rather than by the more complicated and costly alternative of microwave radiometry. Finally, the catheter/adapter connector must be designed so that it heats uniformly (no "cold spots") and be able to withstand repeated uses. Based on the number of these catheters placed in the U.S. annually, the infection rate, the percentage of infections that involve bacteremia, the cost per bacteremia, and mortality from bacteremia, it is estimated that this device could save $64 million (1988 dollars) and spare 1000 to 2000 lives annually in the U.S. alone. PROPOSED COMMERCIAL APPLICATIONS: This device would result in improved healthcare at significant cost savings. Based on the number of these catheters placed in the U.S. annually, the infection rate, the percentage of infections that involve bacteremia, the cost per bacteremia, and mortality from bacteremia, it is estimated that this device could save $64 million and spare 1000-2000 lives annually in the U.S. alone. The market will be significant (both equipment and disposables) since insertion of tunneled central venous lines is an exceedingly common procedure.

所提出的装置旨在对用于接受全肠外营养的患者的隧道式中心静脉导管毂进行消毒。需要这样的装置来减少与使用这些导管相关的感染并发症，这些并发症与重复进入毂有关。尽管使用微波能量对集线器连接进行蒸汽消毒的基本思想可能看起来有些明显和简单，但设计和构建成功设备的技术挑战有很多。加热腔必须小而轻，因为它将靠近患者放置。它必须能够识别盐水环境中的小气泡（<0.1ml）。希望这可以通过反射系数测定来实现，而不是通过更复杂且成本更高的微波辐射测量来实现。最后，导管/适配器连接器的设计必须使其加热均匀（无“冷点”）并能够承受重复使用。根据美国每年放置的这些导管的数量、感染率、涉及菌血症的感染百分比、每次菌血症的成本以及菌血症的死亡率，估计该装置可以节省 6400 万美元（1988 年美元）和仅在美国每年就有 1000 到 2000 人丧生。拟议的商业应用：该设备将改善医疗保健并显着节省成本。根据美国每年放置的这些导管的数量、感染率、涉及菌血症的感染百分比、每次菌血症的成本以及菌血症的死亡率，估计该装置可以节省 6400 万美元，并节省 1000-2000 年的时间。每年仅居住在美国。由于插入隧道式中心静脉管是一种非常常见的手术，因此市场将非常巨大（设备和一次性用品）。