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

SBIR 第一期：高表面积 (HSA) 腔内冷冻消融治疗胆石病高危患者

• 批准号: 1938608
• 负责人: Matthew Nojoomi
• 金额: $ 22.37万
• 依托单位: ICTERO MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-15 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938608&HistoricalAwards=false
• 关键词: SBIR; Phase; Surface; Area; HSA

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to develop a safer alternative to gallbladder surgery for elderly patients at higher risks of complications due to the effects of general anesthesia. Approximately 200,000 Medicare patients undergo surgery to remove their gallbladders every year. Unfortunately, 24% of these patients will experience a perioperative complication due to the effects of general anesthesia, totaling $500 M in cost annually to the US healthcare system. As the population ages and management of chronic disease improves, the need for alternatives to gallbladder surgery increases. This project will develop a process to affect the entire surface of the gallbladder ("ablation"), inducing a healing response that will defunctionalize the gallbladder and obviate the need to remove it. This is the first technology designed to conduct this process within a tube via a minimally invasive approach. Ultimately, this technology could be adapted to create more effective devices for other high surface area tissue targets.The proposed project is a significant improvement over current state-of-practice ablation devices due to its ability to deliver high-surface area ablation within a closed lumen or organ, such as the gallbladder. Existing conductive devices are designed for targeted ablation of discrete lesions rather than therapeutic delivery to large tissue targets, such as the gallbladder. The aim of this project is to develop a new process using open lumen instillation of cryogen to achieve high surface area cryoablation of tissues. This raises several unique engineering challenges, including the design of a delivery mechanism for the uniform distribution of cryogen across a closed lumen and development of a pressure management system to properly evacuate the cryogen gas and prevent an increase in intraluminal pressure. Initial optimization of the cryogen distribution and pressure management system will be conducted using a benchtop thermal load model of the gallbladder to approximate the in vivo thermodynamics. Optimized designs will then be tested in acute and chronic animal models to demonstrate the safety and efficacy of open lumen instillation of cryogen for high surface area intraluminal cryoablation of the gallbladder.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）I期项目的更广泛影响是为老年患者开发一种更安全的胆囊手术替代方案，这些患者由于全身麻醉的影响而具有更高的并发症风险。每年大约有20万名医疗保险患者接受胆囊切除手术。不幸的是，由于全身麻醉的影响，这些患者中的24%将经历围手术期并发症，每年给美国医疗保健系统带来总计5亿美元的成本。随着人口老龄化和慢性病管理的改善，对胆囊手术替代方案的需求增加。该项目将开发一种影响胆囊整个表面的过程（“消融”），诱导愈合反应，使胆囊功能丧失，并消除切除胆囊的需要。这是第一项旨在通过微创方法在管内进行这一过程的技术。最终，这项技术可以适用于其他高表面积组织靶点的更有效的设备，拟议的项目是一个显着的改进，目前的国家的实践消融设备，由于其能够提供高表面积消融在一个封闭的管腔或器官，如胆囊。现有的传导装置被设计用于离散病变的靶向消融，而不是向大的组织靶（例如胆囊）递送治疗。本项目的目的是开发一种新的工艺，使用开放腔灌注冷冻剂来实现组织的高表面积冷冻消融。这提出了几个独特的工程挑战，包括设计输送机构，以使冷冻剂均匀分布在封闭的管腔上，以及开发压力管理系统，以适当地排空冷冻剂气体并防止管腔内压力增加。将使用胆囊的台式热负荷模型对冷冻剂分配和压力管理系统进行初始优化，以近似体内热力学。优化的设计将在急性和慢性动物模型中进行测试，以证明开放腔灌注冷冻剂用于胆囊高表面积腔内冷冻消融术的安全性和有效性。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。