4:21 PM Abstract No. 220 EZ-Access, a novel 3D printed groin puncture device: no imaging needed!

Abstract

Exsanguination is the leading cause of death after vascular trauma. Resuscitative endovascular balloon occlusion of the aorta (REBOA) can control torso hemorrhage. However, adoption of this approach specifically by the military has been limited by challenges in achieving femoral artery access in austere combat environments. To address this need, we developed a novel 3D printed minimally invasive device, termed EZ-Access, to enable successful vascular access without the need for ultrasound guidance or specialized training for use in the field by first responders. EZ-Access was modeled using SolidWorks and 3D printed with a methacrylated resin using FormLabs2 printer. The device measured 14 × 2 × 1cm with two concave thumb rests on either side of a central plate containing 6 equidistant holes spaced at 0.8cm. The holes were fitted with a variable number of 21-gauge 7cm percutaneous entry needles followed by extensive testing. Multiple trials involved IR staff, residents, college and high school students to test success of accurate access of femoral artery using SimuLab models (Seattle, WA). Trial 1 consisted of 3 needles in alternating holes (n = 40). Trial 2 used 6 sequentially placed needles (n = 42). The needles within the device were inserted without ultrasound (US) guidance, two fingerbreadths lateral to the pubic symphysis. The device was angled along the groin crease and the needles entered the skin at 45 degrees. After each puncture, US was used to confirm vessel entry. A control trial was also performed using standard single-entry access needle (n = 5) by staff IR. Statistical analysis performed using Prism software (P = 0.05). The control trial demonstrated vessel entry rate of 20%. Using 3 alternating needles, successful vessel entry increased to 40% (P = 0.396). With 6 sequential needles, vessel entry success significantly increased to 100% (P <0.001) regardless of operator experience. EZ-Access has demonstrated overwhelming success in obtaining consistent percutaneous vascular access in a simulated clinical scenario independent of the operator’s experience without the need for imaging guidance. The device has promising applications in prehospital resuscitation.