MICHIGAN CRITICAL CARE CONSULTANTS, INC. — Department of Defense SBIR Phase I: DHA231-003

Description

The major limitations for the use of ECLS in the far-forward environment are the difficulty of its initiation, the need to adjunctive imaging to avoid damage to the heart and great vessels, and difficulty confirming correct cannula placement both in the far-forward and the transport environments. Thus, our proposed study will design and test two highly innovative features that will directly address the root causes of these concerns. The femoral dual-lumen cannula, which will be developed by MC3 Inc., will allow for the use of ECLS with only one cannula placement instead of two cannula placements (thus, saving time, limiting risks of the neck vessels / heart and two cannula placements), and it gives the ability for one person to cannulate by his/herself independently, safely and rapidly. Its echogenic material throughout the cannula and guidewire will allow for the placement to be confirmed simply by ultrasound. MC3 will utilize technology from MC3’s Crescent™ Jugular Dual Lumen Catheter (Regulation No. 21 CFR 870.4100, Regulatory Class II), which was cleared by FDA with an ECLS indication via a new pathway created for ECLS through the 510(k) clearance process with special controls. We hypothesize that the use of the femoral dual lumen cannula with echogenic material will mitigate the concerns of ECLS initiation, and that this device will result in successful cannulations and decreased overall time for ECLS initiation. The cannula will be tested at the Institute for Extracorporeal Life Support (IELS) using a high-fidelity cannulation simulator. Briefly, providers from hospital, military, and academic settings will receive an orientation with an overview of the cannula, followed by a demonstration of the positioning of cannula. Then, providers will cannulate the left and right sides of the mannequin (initially with guidance and then independently). The IELS will also initiate a series of roundtable discussions that focus on the cannulas’ use in operational environments (point-of-care in an austere environment, ambulance, emergency department, operating room, bedside). This device, particularly with its use of echogenic material throughout the cannula and guidewire, can be translated into a range of products that do not require x-ray or fluorescent dye confirmation, including central lines and feeding tubes.