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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是治疗心力衰竭患者子集的一种新型新兴方法。尽管有现代医学方案和设备治疗，心力衰竭仍影响着600万美国人，并且仍然是美国死亡和住院的主要原因。所提出的系统和方法旨在通过利用用于执行大内脏消融（GSN）的已建立的临床进入程序来提供新颖的程序和治疗范例。该系统将使新兴疗法能够快速、更广泛地在临床上采用。该小企业创新研究第一阶段项目将开发一种新型、微创、导管输送的静脉手术，用于进行血管外大内脏消融（GSN）。申报的导管系统采用临床上可接受的静脉入路进行血管外去神经支配，同时最大限度地减少对其他周围组织的附带（脱靶）损伤。本项目的目标包括设计和原型制作新器械，这些器械将实现局部能量输送，并包含指示手术成功的检测系统。实验室测试和临床前动物模型研究将用于进入和消融，验证设备的功能和性能。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。

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.