This SBIR Phase I project will focus on the development of a catheter specifically designed to reducebleeding complications from catheter-directed thrombolysis (CDT) treatment of pulmonary embolism (PE). PErepresents a leading cause of morbidity in the United States, with as many as 900,000 cases per year in theUnited States alone. One in four patients with PE will die suddenly without warning, and PE is the third mostcommon cause of cardiovascular death. In addition, blood clots represent a significant burden on the economy,with healthcare costs accounting for up to $10 billion dollars annually. CDT involves placing one or more small catheters directly within the blood clot(s) in the lung(s) andinfusing a thrombolytic medication (e.g. tissue plasminogen activator) to dissolve the clots over a 2-24 hourtime period. It is preferred over a peripheral intravenous bolus administration of tPA in all but the highest riskpatients, as a slower, more controlled infusion correlates with lower rates of life-threatening bleeding. While CDT-based thrombolytic infusions can be immensely effective, this therapy carries the risk ofmajor adverse events including catastrophic intracranial, vascular, or intra-abdominal bleeding, and the risk ofbleeding complications is proportional to the dose and duration of thrombolytic infusion. To minimizethis risk, the lowest possible dose of thrombolytic should be infused over the shortest duration. This idealendpoint would be the point when complete lysis occurs and any added thrombolytic only increases riskwithout any therapeutic benefit. To date, no existing CDT device allows for personalized treatment andreal time monitoring of lytic effectiveness to allow for judicious titration of thrombolytic administration.Customer discovery revealed that providers desire pressure data to inform treatment decision-making. The proposed device is a CDT catheter which minimizes the dose of thrombolytic delivered. It does thisby enabling hemodynamic monitoring across a thrombus for real-time detection of thrombus disruption,AND by deploying expanding nitinol lytic "baskets" for maximized thrombolytic contact area with thrombi. Itsall-in-one design makes the procedure easier, safer, and less costly for the hospital. This catheter comprises two telescoping catheters wherein the outer catheter can be translated toselectively expose preformed nitinol tubing baskets for adjustable-length three-dimensional lytic infusion.The combined catheter system has four ports, each designed to address CDT milestones. The device willallow the user to (1) precisely steer the catheter and sub-select a target branch, (2) perform high pressurecontrast injections to obtain diagnostic-quality angiograms, (3) infuse lytic in the full three-dimensional space ofthe vessel to precisely fit and fully saturate the thrombus, and (4) measure real-time, continuous, simultaneous,fluid-filled pressure proximal and distal to a thrombus to determining an appropriate therapy endpoint.
Public Health Relevance Statement: NARRATIVE
Pulmonary embolism (PE) is a life-threatening medical condition which triggers in a cascade of events
leading to right ventricular dysfunction, cardiogenic shock, and ultimately represents a leading cause of
mortality in the United States with as many as 100,000 deaths attributed to it each year. To meet the growing
demand for the minimally invasive management of pulmonary embolism and improve safety and efficacy, this
Phase I project aims to develop a Catheter Directed Thrombolysis device to precisely treat PE patients to their
individual target endpoint of thrombolytic infusion, as a lower dose infusion correlates with lower rates of life-
threatening bleeding. This device will minimize the dose of thrombolytic delivered by enabling hemodynamic
monitoring of PA pressure across a thrombus for real-time detection of thrombus disruption and improving
thrombolytic contact area with thrombi by deploying expanding nitinol lytic "baskets," adjustable to the
thrombus length.
Project Terms:
