I-Corps: Catheter-Based Device to Treat Chronic Heart Failure

I-Corps项目的更广泛的影响/商业潜力是开发一种基于导管的设备，该设备可以进行有针对性的交感神经消融来治疗心力衰竭。慢性心力衰竭的特点是心肌衰弱，这降低了心脏向身体其他部位泵血的能力。作为补偿，神经系统从腹部血管系统转移血容量，以帮助恢复血液流动。虽然这种机制在心力衰竭患者的正常运动期间被安全地激活，但这种机制对心脏和肺部的压力过大，导致肺部积液。这种液体使患者难以呼吸或进行基本的日常生活活动，迫使患者每年多次住院。目前的药物提供了一些临床益处，但在许多情况下，在缓解症状或减少住院率方面是无效的。心力衰竭仍然是一个主要的临床和经济负担，治疗方案有限。提出的技术利用了这种神经-心脏机制，从心脏和肺部取出液体，并将其恢复到一个更安全的地方——腹部电容血管。这种方法可以改善病人的症状，减少住院时间，并可能改变心脏病的病程。通过实施靶向消融，目的是打破心力衰竭患者再住院的循环。I-Corps项目的基础是开发一种设备，用于进行血管内消融，将能量引导到以前只能通过侵入性手术才能进入的组织，供介入医师使用。射频消融已被用于通过凝固组织治疗疾病，但仍存在准确性、手术成功率和对周围组织的附带损伤等问题。所提出的技术依赖于两个组成部分：1)定位目标神经并确认手术完成的电刺激功能；2)与传统消融导管相比，静脉穿刺消融探头提高了准确性，减少了附带损伤，减少了手术时间。该装置为神经调节和神经消融提供了一种解决方案，它专门针对神经并避免附带损伤。此外，这种微创装置的目标是位于胸腔的神经，而不是靠近心脏。因此，心脏病专家可能认为这是一种低风险的手术，可以在门诊进行。通过针对高危心脏病患者，有可能直接解决患者和医疗保健系统的社会需求。该奖项反映了美国国家科学基金会的法定使命，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 I-Corps project is the development of a catheter-based device that performs a targeted sympathetic nerve ablation to treat heart failure. Chronic heart failure is characterized by cardiac muscle weakening, which reduces the heart’s ability to pump blood to the rest of the body. To compensate, the nervous system diverts blood volume from the abdominal vasculature to help restore blood flow. While this mechanism is safely activated during normal periods of exercise in patients with heart failure, this mechanism over-stresses both the heart and lungs, causing fluid accumulation in the lungs. This fluid makes it difficult to breathe or carry out basic activities of daily living, forcing patients to the hospital multiple times each year. Current medications afford some clinical benefit but, in many cases, are ineffective at relieving symptoms or reducing hospital admissions. Heart failure remains a major clinical and economic burden with limited treatment options. The proposed technology leverages this neuro-cardiac mechanism, removing the fluid from the heart and lungs, and restoring it to a safer place — the abdominal capacitance vessels. This procedure may enable improved patient symptoms, reduced hospitalizations, and potentially alter the course of heart disease. By performing targeted ablation, the aim is to break the cycle of rehospitalizations for patients with heart failure.This I-Corps project is based on the development of a device to perform an endovascular ablation that directs energy to tissues previously accessible only by invasive surgery for the interventionalist physician. Radiofrequency ablation has been employed to treat disease by coagulating tissues, but there remain concerns surrounding accuracy, procedure success, and collateral damage to surrounding tissues. The proposed technology relies on two components: 1) an electro-stimulation feature that locates a target nerve and confirms procedure completion and 2) a vein-puncture ablation probe that improves accuracy, reduces collateral damage, and reduces procedure times compared to conventional ablation catheters. The proposed device offers a solution for neuromodulation and nerve ablation that specifically targets nerves and avoids collateral damage. In addition, this minimally invasive device targets a nerve located in the thoracic cavity that is not near the heart. Therefore, cardiologists may consider this a low-risk procedure that may be performed in an outpatient setting. By targeting the highest risk heart disease patients, it may be possible to directly address the societal needs of patients and the healthcare system.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.