This Small Business Innovation Research (SBIR) Phase I 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.
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 parttime 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.
Oramic is developing a novel, energy-based treatment for the efficient emulsification of thrombotic vascular occlusions and quick restoration of blood flow in occluded arteries within minutes after the start of treatment. The system utilizes low energy, high repetition rate pulses delivered via microelectrodes embedded in a disposable microcatheter to create acoustic micro shockwaves (along with vigorous fluidic effects) that will efficiently emulsify clot into sub-capillary size particles. The microcatheter will be used in conjunction with standard guiding catheters and guidewires through femoral access, utilizing established interventional techniques. The proprietary effect can generate vigorous fluidic motion with no moving parts, based solely on the interaction of short voltage pulses with conductive liquids. The electrical pulses are delivered into a novel catheter tip design, which in turn can enhance the aforementioned fluidic effects and cause a suction of the occlusive material into the tip of the catheter for further emulsification. The overall system will consist of a robust and inexpensive pulsed voltage supply, and a novel microcatheter that contains a multitude of microelectrodes, capable of navigating into the tortuous neurovasculature. Construction of durable microelectrode tips up to 150μm in diameter have been demonstrated. The work so far indicates that short voltage pulses, delivered by microelectrodes, into a conductive liquid, can generate vigorous fluidic effects and efficiently emulsify clot at rates of up to 0.6-0.8 grams per minute. This would correspond to the emulsification of a 1cm long clot formation in the M1 arterial vasculature (equivalent to a massive stroke) in about 20-30 seconds; A remarkable achievement, should it also be demonstrated in-vivo. Next major milestones are to build prototype catheters for more in-vitro experiments and for animal studies to verify the final design of the catheter shaft (for accessibility) and tip (for clot emulsification efficacy) as well as the operating parameters of the voltage pulser (pulse width, repetition rate, peak voltage, etc). Human clinical trials will be necessary for the eventual commercialization of the device.