SBIR Phase II:High Surface Area (HSA) Intraluminal Cryoablation for the Treatment of High-Risk Patients with Gallstone Disease

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be the development of the first minimally invasive cryoablation solution to treat high-risk patients with gallbladder disease. The current gold standard for treating gallbladder disease is surgical removal of the gallbladder. While this procedure works well for healthy patients, the use of general anesthesia has been shown to increase complications in elderly patients with underlying chronic medical conditions, leading to a $675 million cost to the US healthcare system each year. Furthermore, patients too sick for surgery have no definitive treatment options, underscoring the need for a safer alternative. Phase I efforts demonstrated the ability to safely deliver cryoablation energy via a minimally invasive catheter system to chronically defunctionalize porcine gallbladders without removal. Phase II efforts will focus on product development of the cryoablation system and optimization of clinical delivery parameters. The goal of the technology is to allow clinicians to provide their patients with the benefits of surgery, without the risk._x000D_ _x000D_ This Small Business Innovation Research (SBIR) Phase II project proposes to continue the development of a minimally invasive cryoablation system capable of safely and effectively targeting the gallbladder. Initial testing of the cryoablation system has demonstrated the ability to uniformly generate lethal cryoablation temperatures (less than-20℃) across the gallbladder lumen, leading to durable gallbladder scarring and defunctionalization in porcine animals up to 60 days post-procedure. Key technical objectives of this project are to develop the industrial design of the introducer, cryoablation catheter, and control system for improved clinical usability and manufacturability, to further test and characterize clinical delivery parameters to inform treatment planning, to improve sensor reliability and control system response time to optimize safety profile, and to validate the integrated system in vivo to demonstrate system performance with optimized dosing parameters. The system will be evaluated in an advanced benchtop model gallbladder under a thermal load, ex vivo gallbladder tissues, and an in vivo chronic animal model to optimize and validate the cryoablation catheter and integrated control system. The anticipated result of this project is a clinically viable gallbladder cryoablation system with established clinical delivery parameters and dosing guidelines._x000D_ _x000D_ This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.