Transesophageal Aortic Blood Flow Occluder: A Novel Device to Control Non-Compressible Torso Hemorrhage
Abstract
When people suffer from massive bleeding, they go into hemorrhagic shock, which is a leading cause of severe hospital complications and death in the United States and throughout the world. The most common cause of such severe bleeding associated with catastrophic outcomes is injury or trauma. Shock from massive blood loss due to a traumatic injury is now considered the leading cause of preventable death in both the civilian and military trauma patient populations. Direct pressure and tourniquets to manage easily identified bleeding from an extremity injury have significantly improved survival from such visible injuries. However internal bleeding within the chest, abdomen, and pelvis is hidden from the naked eye and thus inaccessible and continues to bleed. Such uncontrolled bleeding in the torso is not amenable to direct pressure, is referred to as non-compressible torso hemorrhage (NCTH), and frequently leads to hemorrhagic shock and death. Recent studies of U.S. casualties during the wars in Iraq and Afghanistan and of civilian trauma patients confirmed that severe bleeding remained the leading cause of preventable death and estimated that 50% of early deaths after injury are due to NCTH. There are limited clinical interventions to treat NCTH, with emergency surgery being the best option to quickly and directly stop the life-threatening bleeding. In both military and civilian trauma, earlier hemorrhage control was also associated with improved survival. Unfortunately, the tourniquet cannot be applied to effectively control NCTH, and it remains an unmet clinical need. The major objective of this effort to address this critical unmet need is to advance the development of a device called the Trans-Esophageal Aortic Blood flow Occluder (TEABO). It provides a minimally invasive strategy of occluding aortic blood flow into the abdominal cavity and controlling inaccessible internal bleeding. The device uses a tube placed through the esophagus in a manner similar to other minor procedures that utilize oral-gastric tubes and procedural scopes that do not require a physician to insert. Proximal hemorrhage control is achieved through a posterior actuator deployed and pressed against the esophageal wall to compress the underlying aorta. The long-term goal is U.S. Food and Drug Administration (FDA) approval of this device for clinical and field use in the management of internal bleeding or NCTH. Hypothesis/Objective: We hypothesize that this technique of trans-esophageal aortic occlusion is a feasible and practical strategy for control of NCTH. Early prototype development has successfully demonstrated the proof of concept for this device. A flexible tube capable of insertion into the stomach through the esophagus was created. A deployable and retractable compression mechanism capable of covering the entire aortic diameter and providing proximal aortic control was also created. This simplified placement strategy significantly increases the number of potential operators able to control NCTH. The next steps in development of this hemorrhage control device include the following specific aims: Specific Aim 1: Optimize the initial proof-of-concept prototype by developing a prototype to establish the feasibility and technical capability of achieving trans-esophageal aortic compression. While the results from the initial basic prototype are encouraging, additional work is necessary to develop this promising technology into a quality clinical device that meets clinical performance requirements. The device would then be ready to start testing necessary for regulatory approval. To achieve this aim, we will continue to contract with a professional medical manufacturing company to produce a higher grade and more sophisticated device ready for preclinical testing that will entail a stepwise process with multiple prototype iterations. Specific Aim 2: Validate these prototype iterations in a clinically relevant pressurized cadaver mode
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210037
Entities
People
- Joseph Rabin
Organizations
- United States Army
- University of Maryland, Baltimore