Preclinical evaluation of the atraumatic nature of a spring loaded blunt tip coaxial needle in a swine model.

To test in vivo in an animal model the inherent atraumatic characteristics of the spring loaded blunt tip of a coaxial needle (Gangi-SoftGuard®, Apriomed, Sweden) against a conventional sharp stylet coaxial needle. The study was conducted on a 40kg male swine that was its own control for a vascular trauma model. The procedure consisted of voluntary attempts to transfix and traverse the artery/aorta under continuous real-time angiogram. Test and control needles were positioned in the region of the intercostal, superior mesenteric and femoral/deep femoral arteries, and in the aorta. Computed tomography (CT) angiogram was performed post trauma to check for bleeding in the form of extravasation of contrast material. One attempt was performed per site and needle, except for the intercostal artery where a second attempt was done with the test needle, resulting in a total of 4 and 5 tests for the control and test needles, respectively. With the spring loaded blunt tip, no vascular trauma or bleeding was noted in the intercostal, superior mesenteric and femoral arteries, nor in the aorta. Vascular spasm that recovered with time was noted during the second attempt to transfix the same intercostal artery. There were consistent vascular traumas and bleedings with the control needle in all three tested arteries and the aorta, confirmed on angiogram as well as CT angiogram. The atraumatic feature offered by the spring loaded blunt tip prevented vascular trauma during the 5 attempts made to transfix the artery/aorta in a swine.

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