SBIR Phase II: Novel Thrombolysis Microcatheter System for the Clearing of Neurovascular Occlusions

This Small Business Innovation Research Phase II project focuses on the design and construction of a medical device that treats ischemic stroke by virtue of breaking-down endovascular occlusions using a proprietary Electro-Fluidic Thrombolysis (EFT) technology. EFT utilizes low energy electrical pulses to create acoustic micro shockwaves (along with vigorous fluidic effects) that will efficiently emulsify clot into sub-capillary size particles. This effect generates vigorous fluidic motion with no moving parts based solely on the interaction of short voltage pulses with conductive liquids (such as saline or blood). The electrical pulses are delivered via microelectrodes into an engineered tip design at the distal end of a catheter, causing a suction of the nearby occlusive material into the tip for further safe emulsification without causing any damage to the surrounding tissue. Currently available therapies to physicians offer low performance as they take hours to complete the treatment. In the case of clot-busting drugs, the added contraindications limit their use to less than 4% of the population. The expected speed and effectiveness of EFT will offer improved patient outcomes, and reduced costs; since in the case of stroke, lack of effective therapies are associated with enormous costs for rehabilitation and long term care. The broader impact/commercial potential of this project will be the development of a disposable microcatheter that works as an intelligent delivery system along with an inexpensive voltage generator for the effective and safe emulsification of intracranial occlusions for the treatment of ischemic stroke. Ischemic Stroke remains the third leading cause of death in the US with approximately 20% of the nearly 700,000 annual victims dying shortly after the initial attack, while most survivors require full or part?time care. The understanding of the effects of short electrical pulses with conductive liquids (such as saline or blood) and the resultant mechanical and fluid-dynamic effects would be essential in transforming this technology to a true platform technology with several medical applications. Although the initial market focus is ischemic stroke, it is believed that this platform technology can also be used to recanalize coronary and peripheral vessels. The proposed approach to endovascular thrombolysis offers several advantages over drug therapy and other medical devices, including improved patient safety, more rapid recanalization and fewer contraindications.