Development of Advanced Occlusion Controller (APOC) for pREBOA to Include Development of Next-Generation pREBOA-PRO
Abstract
Objectives and Rationale for the Research: Current resuscitative endovascular balloon occlusion of the aorta (REBOA) technologies, including the ER-REBOA? Catheter, have demonstrated excellent total occlusion and blood pressure monitoring of large vessels. However, due to flow characteristics and balloon geometry, existing REBOA balloons are not capable of giving the user smooth control of occlusion and the ability to fine tune the infra-occlusion pressure, properties that are critical to performing effective partial REBOA (pREBOA). The overall intent of this effort is to develop a next-generation pREBOA catheter and to create an advanced partial occlusion controller (APOC) for pREBOA that does not require an extracorporeal circuit. Focus Area(s) Addressed: There is a need for reliable, safe, but simple methods to control severe hemorrhage on the battlefield while addressing ischemia and reperfusion injury risk. An APOC for pREBOA system provides this capability and aligns perfectly with Focus Area 3, determination of more effective and efficient ways to manage vascular disruption in forward surgical and limited-resource critical care environments, and Focus Area 4, innovative patient-centered technologies to maintain physiological equilibrium such as dynamically responsive closed-loop technologies. Types of Military and/or Civilian Patients It Will Help: The APOC for pREBOA system will be designed to enable enhanced treatment of military injuries in forward surgical, en route, and critical care settings. Similarly, it will benefit civilian patients suffering trauma-related severe hemorrhage, including car crashes and other trauma. Potential Clinical Applications, Benefits, and Risks: There is a growing clinical need to provide for a broad range of solutions in forward surgical, en route, and critical care settings, and in particular to support prolonged damage control resuscitation (pDCR) techniques that help mitigate the negative effects of delayed surgical intervention. Severe hemorrhage, particularly non-compressible torso and junctional hemorrhage, continues to be the leading cause of potentially survivable US deaths in combat. The military has the need to develop novel devices and strategies to control severe hemorrhage on the battlefield. Combining this new pREBOA catheter with an APOC that does not require an extracorporeal circuit will fully enable pREBOA capabilities in far forward and other intensive critical care settings to provide rapid, safe endovascular access in settings of hemorrhagic shock. Technical risks such as prototype development, composite balloon systems, spine balloon bonding, and concerns with open and/or closed loop control systems are detailed along with mitigation approach. Benefit for Service Members, Veterans, and/or Their Family Members: Since August 2016, there are increasing reports of down range prehospital combat use of REBOA. Although details regarding these real-life scenarios are classified, the extension of endovascular hemorrhage control adjuncts into a forward location is becoming reality. Combining pREBOA-PRO? catheter with an APOC will fully enable pREBOA capabilities to support precision medicine techniques to manage vascular disruption and maintain physiological equilibrium in settings of forward surgical, en route, and critical care, and in particular to support precision medicine techniques expected to benefit service members, Veterans, their families as well as a vast civilian population.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 05, 2019
- Source ID
- W81XWH1920007XX0
Entities
People
- John B Holcomb
Organizations
- Prytime Medical (United States)
- United States Army