Design and Evaluation of a Novel Thrombectomy Device

Abstract Deep vein thrombosis is a disease that occurs when a blood clot is formed in a vein and occludes the vessel lumen, blocking the blood flow, causing pain and even disability and possibly leading to complications such as postthrombotic syndrome and pulmonary embolism. Treatments for DVT include mechanical thrombectomy: introducing a device into the vasculature to remove thrombus. Currently used devices either macerate the thrombus to aid removal or pierce the thrombus to reach its distal side. This can pose risk of fragmentation or distal embolization, or in case of fibrous, cohesive thrombi can be hard to achieve due to their resistance to deformation. The following study proposes an alternative approach of bypasing the thrombus via the space between the thrombus and the vessel wall in order to avoid thrombus penetration. The design implements a strategy of simultaneously gripping the clot and expanding the vessel lumen in order to create space between the thrombus and the vessel wall while advancing along the clot’s length in incremental steps. The prototype has been evaluated in a custom-made experimental setup using phantom vessels and thrombi analogs. The proof-of-concept experiments have shown that the device can successfully bypass and in some cases even remove thrombi. The study shows promising results for this new kind of device and can be a foundation for future research into applying similar removal strategies in thrombectomy.