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

SBIR II 期：高表面积 (HSA) 腔内冷冻消融治疗高危胆石病患者

• 批准号: 2214634
• 负责人: Matthew Nojoomi
• 金额: $ 96.66万
• 依托单位: ICTERO MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-15 至 2024-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2214634&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Surface; Area

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.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 (-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.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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力将是第一个为治疗胆囊疾病的高危患者的最低侵入性冷冻解决方案的开发。当前用于治疗胆囊疾病的金标准是手术去除胆囊。尽管此手术对健康患者效果很好，但已证明使用全身麻醉可以增加患有慢性医疗状况的老年患者的并发症，每年为美国医疗保健系统造成6.75亿美元的成本。此外，对手术的病人病得不到明确的治疗选择，强调了需要更安全的替代方案。第一阶段的努力证明了通过微创导管系统安全地传递冷冻能量的能力，可以长期破坏猪胆囊而无需去除。第二阶段的工作将集中于冷冻系统的产品开发和临床输送参数的优化。该技术的目的是允许临床医生为患者提供手术的好处，而没有风险。此小型企业创新研究（SBIR）II期项目提案，以继续开发能够安全有效地针对胆囊的微型侵入性冷冻系统。冷冻系统的初步测试表明，能够在胆囊管腔上均匀地产生致命的冷冻温度（-20℃），从而导致猪动物在猪动物中持久胆囊疤痕和解化后，长达60天后，制造后处理。 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 manufacturing, 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.该系统将在热载荷下的高级台式模型胆囊，离体胆囊组织和体内慢性动物模型下进行评估，以优化和验证冷冻浮动导管和集成控制系统。该项目的预期结果是具有临床上可行的胆囊冷冻系统，具有既定的临床交付参数和给药指南。该奖项反映了NSF的法定任务，并通过基金会的智力优点和更广泛的影响标准通过评估来诚实地支持。