REBOA Physiologic Sensing Catheter for Advanced Control of Noncompressible Torso Hemorrhage
Abstract
This proposal addresses non-compressible torso hemorrhage (uncontrolled abdominal bleeding), which is a high priority problem identified by the Combat Casualty Care Research Program within the Joint Warfighter Military Research Program Funding Opportunity. The medical device technology described here will improve on existing technology to stop uncontrolled bleeding and will improve survival for combat casualties. We will develop a medical device that can stop bleeding in the abdomen (belly) and pelvis (hips and groin). In military combat casualties, these injuries to the abdomen and pelvis are particularly deadly, as they cause rapid blood loss and are not easily addressed with other bleeding control techniques such as tourniquets and bandages. Prytime has developed, and the military has used in a combat setting, a first-generation bleeding control device that is introduced into the blood vessels in the trunk and advanced into the chest, where it can be activated to stop ongoing bleeding in the abdomen and pelvis while diverting life-sustaining blood flow to the heart and brain. This current device, the ER-REBOA™ catheter, has also been widely used in civilian trauma hospitals in the U.S., Canada, and Europe. However, this device has limitations that need to be addressed to better address future military needs. This proposal will solve the most important limitation of current technology for use in battlefields of the future. The ER-REBOA™ Catheter can be used for only 30 to 60 minutes without serious risk of lethal injury to the intestines and kidneys due to lack of blood flow. We will develop a new catheter with two main capabilities: (1) the catheter can still slow uncontrolled bleeding, but allow some blood to reach important organs (intestines and kidneys), and (2) measure molecules in the blood that indicate potential irreversible injuries due to the use of the REBOA catheter. These new features will allow clinical providers to use the REBOA catheter more safely. After developing a prototype with these important innovations, we will test the device in animal models that simulate military casualties injured in war. These simulated casualties will have life-threatening bleeding in the abdomen and be treated with the bleeding control device described above. Testing of the bleeding control device will also be used to guide the production of a final product, which will be submitted to the Food and Drug Administration for approval so it can be provided to doctors caring for the most severely injured combat casualties. This research team includes scientists, engineers, and physicians working in military research programs, civilian trauma centers, and two medical device companies, all of whom have a proven track record of collaboration to develop innovative medical products and bring those medical products all the way through the research process and into military hospital use. We will use the same approaches that have proven effective in previous efforts to field products to improve the care of military casualties. Likewise, this team has proven the ability to bring these innovations to civilian hospitals to improve the care of patients injured in car accidents, falls, shootings, stabbings, and other traumatic events. When complete, the medical devices resulting from this research will be made available in civilian trauma centers to improve the care of veterans, military families, and other Americans. The products of this research will require 2-3 additional years of work to obtain approval from the Food and Drug Administration and enter clinical use.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110121
Entities
People
- David Baer
Organizations
- Prytime Medical (United States)
- United States Army