A Universal Device for Performing Cricothyrotomies

Many emergency cricothyrotomy kits have been developed in an attempt to simplify this potentially life-saving medical procedure. However, none of the existing kits perform noticeably better than the standard surgical kit. The standard kit itself has led to a reported failure rate of 33% when performed in combat environments, and airway obstruction is reported to be the third most preventable cause of death on the battlefield. The high failure rate is at least partially attributable to inadequate training and experience. As such, InnoVital Systems, Inc. proposes to develop an innovative universal device that is light weight, packable, and adjustable to different size soldiers or patients that will significantly increase ease of use and efficacy of performing cricothyrotomies. Building upon our experience in medical device design, evaluation, and clearance, we will perform design, analysis, fabrication, and FDA clearance planning in Phase I of the project, which will end with prototype bench tests. Phase II will focus on further design refinements and functional hardware validation of the final design with selected materials, and executing the steps necessary for FDA device clearance.