SBIR Phase I: An extravascular bipolar catheter for targeted nerve ablation with minimal collateral damage to surrounding tissues

SBIR 第一期：血管外双极导管，用于靶向神经消融，对周围组织的附带损伤最小

• 批准号: 2213155
• 负责人: Tyler Melton
• 金额: $ 25.58万
• 依托单位: CARIDIAN MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2213155&HistoricalAwards=false
• 关键词: SBIR; Phase; extravascular; bipolar; catheter

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel and emerging method for treating a subset of heart failure patients. Despite modern medical regimen and device therapies, heart failure affects 6 million Americans and remains a leading cause of death and hospitalization in the United States. The proposed system and approach aim to provide a novel procedure and treatment paradigm by leveraging an established clinical access procedure for performing Greater Splanchnic Ablation (GSN). The system would enable rapid and wider clinical adoption of the emerging therapy.This Small Business Innovation Research Phase I project will develop a novel, minimally invasive, catheter-delivered, venous procedure for performing extravascular Greater Splanchnic Ablation (GSN). The proposed catheter system utilizes a clinically accepted venous approach in order to perform extravascular denervation, while minimizing collateral (off-target) damage to the other surrounding tissues. The objectives of this project include designing and prototyping new devices that will enable localized energy delivery and incorporate a detection system indicative of procedural success. Both benchtop testing and pre-clinical animal model studies will be used to access and ablate, verifying the function and performance of the device.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期项目的更广泛的影响/商业潜力是一种新颖而新兴的方法，用于治疗心力衰竭患者的子集。尽管现代的医疗方案和设备疗法，心力衰竭仍影响600万美国人，并且仍然是美国死亡和住院的主要原因。提出的系统和方法旨在通过利用既定的临床通道程序来进行更大的斑点消融（GSN）来提供新的程序和治疗范式。该系统将能够快速且更广泛的临床采用新兴疗法。该小型企业创新研究阶段I项目将开发一种新颖的，微创的，导管损坏的静脉，静脉输送程序，用于执行血管外更大的斑点消融（GSN）。提出的导管系统利用一种临床上接受的静脉方法来进行血管外神经支配，同时最大程度地减少了对其他周围组织的抵押（脱靶）损害。该项目的目标包括设计和原型设计新设备，这些设备将使本地化能量传递并结合一个指示程序成功的检测系统。台式测试和临床前动物模型研究都将用于访问和消融，验证设备的功能和性能。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子的评估和更广泛的影响来通过评估来支持的。