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

I-Corps：治疗慢性心力衰竭的导管装置

• 批准号: 2225386
• 负责人: Ishan Kamat
• 金额: $ 5万
• 依托单位: Baylor College of Medicine
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2225386&HistoricalAwards=false
• 关键词: Corps; Catheter; Based; Device; Treat

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.

该I-Corps项目更广泛的影响/商业潜力是开发一种基于导管的器械，该器械可进行靶向交感神经消融术治疗心力衰竭。慢性心力衰竭的特征是心肌衰弱，这降低了心脏向身体其他部位泵血的能力。为了补偿，神经系统将血液从腹部脉管系统转移，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，但这种机制会使心脏和肺部过度紧张，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，迫使患者每年多次前往医院。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方面无效。心力衰竭仍然是一个主要的临床和经济负担，治疗选择有限。这项技术利用了这种神经心脏机制，从心脏和肺部清除液体，并将其恢复到更安全的地方-腹部电容血管。这种手术可以改善患者症状，减少住院治疗，并可能改变心脏病的病程。通过进行靶向消融，目的是打破心力衰竭患者再次住院的循环。I-Corps项目是基于开发一种用于进行血管内消融的设备，该设备将能量引导到以前只能通过介入医生的侵入性手术才能到达的组织。放射性消融已被用于治疗由组织引起的疾病，但仍存在关于准确性、手术成功率和对周围组织的附带损伤的问题。所提出的技术依赖于两个组件：1）定位目标神经并确认手术完成的电刺激功能，以及2）与传统消融导管相比，提高准确性、减少附带损伤并减少手术时间的静脉穿刺消融探头。 申报器械提供了一种神经调节和神经消融的解决方案，专门针对神经并避免附带损伤。 此外，这种微创设备的目标是位于胸腔中的神经，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。 该奖项反映了NSF的法定使命，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。