Image-guided Non-invasive Ultrasonic Thrombolysis Using Histotripsy
Deep vein thrombosis (DVT), clot formation in the deep veins in the legs, affects two million Americans annually. Clinical DVT treatments include thrombolytic drugs and catheter-based surgical procedures. Both methods have significant drawbacks, such as excessive bleeding and invasiveness. Guided by ultrasound imaging, histotripsy is a non-invasive cavitation-based ultrasound therapy that fractionates tissue. Using our laboratory prototype, histotripsy fractionated in vitro clots into debris smaller than red blood cells at a speed an order of magnitude faster than clinical thrombolysis methods. Using an in vivo porcine DVT model, histotripsy non-invasively eradicated the thrombus in 10 of 12 cases. We have designed and constructed an integrated ultrasound image-guided histotripsy thrombolysis system based on human DVT patient data. We propose a comprehensive pre-clinical study to determine the safety and efficacy of this clinically designed histotripsy system in a porcine DVT model. The proposed study is critical to advancing the clinical translation of this new technology to improve the standard of care for DVT patients.