SBIR Phase I: A novel clot removal system for improved Venous Thromboembolism (VTE) thrombectomy outcomes

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是一种新的系统，用于以更有效的方式治疗静脉血栓栓塞症(VTE)，VTE是患者深静脉或肺动脉中的一种阻塞血流的血栓。每年有120万美国人受到VTE的影响，导致10万人死亡，100亿美元的直接医疗费用和690亿美元的经济影响。尽管采用了现代化的治疗方法和程序，但被诊断为静脉血栓栓塞症的患者中，有一半以上会出现包括血栓后综合症在内的长期并发症，导致功能障碍，并在确诊后10年内无法重返工作岗位。该系统旨在通过清除血栓和恢复血液循环来提高机械血栓摘除手术的临床效果，从而改善患者的预后并降低长期患者护理成本。这项小型企业创新研究(SBIR)第一阶段项目旨在展示一种新的基于导管的系统在机械血栓摘除过程中固定和清除血栓的可行性。该技术旨在有效地清除血块，同时以最少的失血量对血管无损伤，以便显著改进现有的血块捕获或清除方法。活动范围包括开发第一代原型，并演示原型能够在不堵塞的情况下摄取大量凝块，也不会对其他血管结构造成损害。该设备的设计和原型尺寸将符合临床接受的导管尺寸，并使用临床前工作台和动物模型对各种血栓大小、形状和机械性能进行验证。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 I project is a novel system for treating Venous Thromboembolism (VTE), a clot in the patient’s deep veins or pulmonary arteries which blocks blood flow, in a more effective manner. Each year 1.2 million Americans are affected by VTE resulting in 100,000 deaths, $10 billion of direct medical costs, and $69 billion of economic impact. Despite modern treatments and procedures over half of all patients diagnosed with VTE will suffer long-term complications including Post-Thrombotic Syndrome, resulting in functional disabilities and the inability to return to work within 10 years of diagnosis. The proposed system aims to improve the clinical effectiveness of mechanical thrombectomy procedures by removing clots and restoring circulation, thereby improving patient outcomes and reducing long term patient care costs.This Small Business Innovation Research (SBIR) Phase I project aims to demonstrate the feasibility of a novel catheter-based system for securing and removing clots during mechanical thrombectomies. The technology aims to effectively remove clots while being both atraumatic to the vessel with minimal blood loss, in order to significantly improve upon existing clot entrapment or removal approaches. The scope of activities includes developing a first-generation prototype and demonstrating the prototype enables the ingestion of large clot volumes without clogging nor causing damage to other vascular structures. The device will be designed and prototyped within the dimensions needed to fit within a clinically accepted catheter size and validated using preclinical bench-top and animal models across a wide variety of clot sizes, shapes and mechanical properties.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.