Endovascular Aortic Control (EVAC) Modular Disposable Catheter Research & Development

Non-compressible truncal hemorrhage is a leading cause of potentially survivable death in United States warfighters. A study of 4,596 battlefield fatalities from Operation Iraqi Freedom and Operation Enduring Freedom determined that hemorrhage accounted for 91% of potentially survivable fatalities occurring prior to arrival at a Medical Treatment Facility with 67% of those deaths were from truncal hemorrhage. Advanced Resuscitative Care requires not only methods of hemorrhage control but also high-fidelity physiologic monitoring to guide the proper application of adjuncts like Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). Without high-fidelity physiologic inputs like systemic arterial pressure, the provider providing ARC has to rely only on intuition. Current REBOA technology can only be utilized for 30 minutes, less than the golden hour, before profound tissue ischemia develops below the level of aortic occlusion. A more intuitive system with precision and automated control has the potential to dramatically improve survival in both the civilian and military settings. The development plan for the EVAC disposable catheter is broken into two primary development efforts: sensor development and catheter development. Both development activities will occur simultaneously to reach integration, testing, documentation, and report generation in the final portion of the project. Certus Critical Care, Inc. has initiated the development of the novel digital output sensor that will greatly reduce the size and complexity of the EVAC system. The new configuration will also allow for a simpler attach/detach strategy of the sensor subsystem from the rest of the system’s electronics and mitigate many of the size and calibration requirements for sensor. This proposal is focused on the further development of the sensor chip as it moves towards production readiness and the development of the disposable, lightweight EVAC catheter. While this novel sensor has broader implications for any medical device and technology requiring pressure or force transduction, its immediate application is in our next-generation endovascular catheters for precision hemodynamic management and hemorrhage control. We hypothesize that this design will prove superior to existing analog sensors, enabling simplified electrical design with greater immunity to noise. We further propose that our sensor can be integrated into interchangeable EVAC catheters to provide greater immunity to electrical noise and a simplification/miniaturization of the system electronics while also facilitating integration into a reusable catheter controller.