SBIR Phase I: Non-blood contacting, less invasive device for restoration of ventricular diastolic recoil

该SBIR I期项目旨在解决美国近400万患有舒张性心力衰竭（DHF）的患者缺乏获批器械治疗的问题-这种疾病的潜在市场估计约为50亿美元。在DHF中，心脏的腔室变得僵硬并且不能完全放松，减少了它们填充血液的量，从而减少了每个心动周期期间心脏泵送的血液量。治疗DHF的唯一循证疗法是控制血压升高，并治疗相关并发症。DHF是住院的主要原因，患者结局不佳，在过去二十年中没有任何明显的改善。因此，迫切需要一种有效的器械解决方案，可以缓解DHF相关症状，同时改善患者结局，并进一步了解导致DHF的关键因素和机制。该项目的重点是开发一种非血液接触双心室舒张期反冲装置，用于治疗射血分数保留性心力衰竭（HFpEF）（也称为舒张性心力衰竭（DHF））患者。申报器械将提供一种获得专利的微创、非血液接触方法，以缓解与HFpEF相关的症状，解决目前缺乏任何获批器械治疗的市场中大量未满足的需求。该I期项目的主要目标包括在初步动物研究中调查器械设计、功能和机械性能的变化，以优化心脏功能和血液动力学的增强，以及开发加速疲劳试验装置以测试器械组件的耐久性。将这种新设备推向市场的商业化努力将通过减轻症状，显著提高生活质量，降低发病率和死亡率来解决数百万美国DHF患者的基本未满足的需求。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。

This SBIR Phase I project seeks to address the lack of approved device therapies available for the almost 4 million patients in the U.S. who suffer from diastolic heart failure (DHF) - a disease for which the potential market is estimated to be approximately $5B worldwide. In DHF, the chambers of the heart become stiff and cannot relax completely, reducing the amount with which they fill with blood and thus reducing the amount of blood pumped by the heart during each cardiac cycle. The only evidence-based therapy to treat DHF is to manage blood pressure pharmacologically, and treat associated complications. DHF is a major cause of hospital admissions and has poor patient outcomes, without any discernable improvement over the last two decades. Thus, there is a strong need for an effective device solution that can alleviate the symptoms associated with DHF while improving patient outcomes, as well as further fundamental understanding of the key factors and mechanisms that lead to DHF. This project is focused on the development of a non-blood contacting biventricular diastolic recoil device for the treatment of patients with heart failure with preserved ejection fraction (HFpEF), also referred to as diastolic heart failure (DHF). The proposed device will provide a patented minimally invasive, non-blood contacting approach to mitigate the symptoms associated with HFpEF, addressing a large unmet need in a market which currently lacks any approved device therapies. Primary goals of this Phase I project include investigating variations in device design, functionality, and mechanical properties in pilot animal studies in order to optimize augmentation of cardiac function and hemodynamics, as well as the development of an accelerated fatigue test apparatus to test the durability of the device components. The commercialization effort in bringing this novel device to market will address the largely unmet need for the millions of Americans who suffer from DHF by alleviating symptoms, significantly increasing quality of life, and reducing morbidity and mortality.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.