A «Push&Plug» Lifesaving Device to Prevent Exsanguination

Abstract

Introduction:Severe bleeding from external wounds is a major reason for death. Immediate control of hemorrhage is of highest priority. We present the novel Acute Wound Occluder (AWO) which was developed for rapid and targeted wound occlusion. Here, we present the design, in-vitro testing, and in-vivo performance compared to QuikClot® using a clinically-relevant pig model.Method:AWO is made of an applicator with pushing function into which a self-expanding, Silicone coated Nitinol meshgraft is mounted to enable plugging into the wound-channel. In-vitro tests included biocompatibility, cytotoxicity, skin sensitization, and aging validation. Next, 12 pigs underwent standardized sized femoral-artery puncture to mimic life-threatening bleeding and were either treated with the AWO (n=6) or QuikClot® (control). Animals were followed-up for 4hrs, before device-removal macroscopic assessment.Results:The AWO successfully passed all in-vitro tests. The AWO could be delivered within 40±15 seconds to the wound to achieve instant bleeding control, and no additional manual compression needed. Quick Clot application was less convenient, with approximately four minutes (application 56±8ss, plus three minutes of manual compression) to achieve bleeding control. In all AWO treated pigs, exsanguination could be prevented immediately, no major blood-pressure drops occurred, with four pigs where bleeding could be completely stopped, and two pigs with irrelevant oozing which stopped within 75-150 seconds leading to minimal blood-loss of 12ml and 2ml. Tissue-analysis showed only small hematomas in five out of six animals. In contrast, QuickClot treated pigs showed significant bleeding and a blood-loss of 19ml. All six pigs showed substantial hematomas, two out of six showed very large hematomas. AWO application appeared to be safe with no peri-procedural adverse-events (AEs) or collateral damage to surrounding tissues.Conclusion:The AWO enables rapid and targeted control of life-threatening bleeding without any AEs. The AWO may represent a promising hemostatic device for bullet or knife-stab wounds.