An Automated System for Hemorrhage Control and Resuscitation at Point of Injury

Non-compressible torso hemorrhage (NCTH) is the leading cause of death among survivable battlefield injuries. These types of hemorrhages result from bleeding that cannot be controlled with a tourniquet or application of direct pressure. Additionally, within the civilian US sectors, bleeding from trauma creates a significant death toll among survivable injuries.   With the advent of resuscitative endovascular balloon occlusion of the aorta (REBOA) lives are now being saved. However, the current form of REBOA creates a full blockage of blood flow, resulting rapidly in organ damage distal to the occlusion balloon. In addition to such severe tissue ischemia, there is possibility of metabolic derangements upon reperfusion. New research has led to the opportunity to create partial blockage to extend the survival window by allowing a minimal amount of blood past the balloon and mitigate the ischemia-reperfusion metabolic injury. Currently, no device exists that can perform this "partial REBOA" automatically, thus trauma clinicians and medics must manually manipulate the device and guess at the amount of blood to allow past the occlusion. While REBOA has been recognized as a breakthrough procedure for saving lives, recent research on the clinical impact of REBOA has led to several observations that highlight the limitations of the current protocol and give rise to need for further development, training, and education. These findings provide evidence of the need for a more automated system that will create better opportunity for use in trauma scenarios as well as make the procedure more widely available to medics and first responders.    Hence, the requirement identified and opportunity created for Autonomous Healthcare is to automate the procedure through the use of a feedback control system and an accompanying balloon integrated with pressure sensors to further facilitate the deployment of this technology.      We propose to develop an automated hemorrhage control and resuscitation technology to be used at the point of injury. The technology includes a closed-loop algorithm embedded in a compact (credit card-sized) computing device that continuously receives invasive blood pressure data from a custom integrated catheter/balloon/sensor. The computing device computes the required occlusion balloon inflation to regulate aortic blood flow to a desired value set by the clinical user. The inflation/deflation is performed automatically by a computer-controlled infuse/withdraw syringe pump connected to the computing device.