SBIR Phase II: Minimally invasive device for restoration of ventricular diastolic recoil without blood contact

这一小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是为患有舒张性功能障碍(心脏松弛/充盈不足)的心力衰竭(HF)患者提供基于设备的治疗选择，因为目前的治疗方法大多无效。大约一半的心衰患者有舒张期功能障碍，这相当于美国大约有400万患者。目前还没有治疗这种疾病的根本原因的疗法。因此，存在着对一种解决方案的巨大需求，该解决方案可以缓解症状，同时纠正和逆转导致疾病进展的异常心脏机制。建议的方法改善了自然心脏功能，导致真正从疾病中恢复。这项技术将为数百万美国人提供有效的治疗，提高生活质量，改善患者结局，拯救许多人的生命。这个小型企业创新研究(SBIR)项目推动了一种心脏护理设备的发展。具体地说，该项目将：(1)在慢性舒张性心脏病的动物模型上展示和评估设备在增加心脏松弛方面的功效；(2)确定材料规格和设备设计；(3)进行台式疲劳测试和评估，包括开发定制的寿命测试设备；(4)准备将设计移交给适当的医疗设备制造商；以及(5)在动物模型上进行GLP安全试验。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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 II project is to provide a device-based therapeutic option to heart failure (HF) patients with diastolic dysfunction (insufficient heart relaxation/filling), as current treatments are largely ineffective. Approximately half of people with HF have diastolic dysfunction, equating to an estimated 4 million patients in the US. There are currently no therapies that treat the underlying causes of this disease. Thus, a vast unmet need exists for a solution that can relieve symptoms while correcting and reversing the aberrant heart mechanics that contribute to disease progression. The proposed approach improves native heart function, leading to true recovery from the disease. This technology will provide effective treatment to millions of Americans, improving quality of life, patient outcomes, and saving many lives. This Small Business Innovation Research (SBIR) project advances a device for cardiac care. Specifically, this project will: (1) demonstrate and evaluate device efficacy in increasing heart relaxation in an animal model of chronic diastolic heart disease; (2) determine materials specifications and device design; (3) conduct benchtop fatigue testing and evaluation, including the development of a custom life test apparatus; (4) prepare for design transfer to an appropriate medical device manufacturer; and (5) conduct a pilot GLP safety study in an animal model.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.