A Novel Percutaneous Site-Specific Temporary Blood Vessel Occluder with Flow Control

Backround: Rapid control of bleeding is critical for patient survival with vessel injury and bleeding. Bleeding control is currently limited to external compression where feasible, surgery or endo-luminal procedures with balloons, coils or plugs. Surgery is invasive, often with a delay to expedite. Endoluminal control results in permanent occlusion. Our novel temporary Occluder (TO) provides site-specific percutaneous vessel occlusion with flow control to minimize vessel thrombosis, and allows removal when occlusion or control is no longer needed.

Aim: The purpose of this presentation is to present the results of in-vitro and in-vivo pre-clinical testing of the TO.

Methods: In-vitro studies allowed refinement of the TO and delivery system. In-vivo studies were performed on a heparinized, anesthetized ~60 Kilogram pig. A 4F catheter was introduced into the aorta to allow repeat angiograms of the targeted vessels. The TO was delivered under ultrasound guidance, and multiple, complete and partial occlusions, were performed.

Results: On delivery, the TO successfully occluded the femoral artery with total occlusion. Three repeat occlusions, each of 10 minutes duration with release and partial occlusion with distal flow were performed. All complete/partial occlusions were confirmed by angiogram. After removal of the TO, angiography and direct surgical exposure confirmed patency and integrity of the femoral artery with no significant bleeding or surrounding hematoma.

Conclusions: Our study confirms that the novel TO can provide site specific percutaneous occlusion and flow control in large vessels, with major applications in trauma and specific instances where temporary vessel occlusion is required.