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

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是一种新的系统，用于更有效地治疗静脉血栓栓塞（VTE），即患者深静脉或肺动脉中的凝块，阻塞血液流动。每年有120万美国人受到静脉血栓栓塞的影响，导致10万人死亡，直接医疗费用达100亿美元，经济影响达690亿美元。尽管有现代治疗和手术，半数以上被诊断为静脉血栓栓塞的患者仍会出现包括血栓后综合征在内的长期并发症，导致功能残疾，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取栓程序的临床有效性，从而改善患者的预后并降低患者的长期护理成本。这项小企业创新研究（SBIR）一期项目旨在证明一种新型基于导管的系统在机械血栓切除术中固定和去除血栓的可行性。该技术旨在有效去除血块，同时对血管无损伤，减少失血，以显着改善现有的血块夹持或去除方法。活动范围包括开发第一代原型，并演示该原型能够摄入大量凝块而不会堵塞，也不会对其他血管结构造成损害。该设备将在临床接受的导管尺寸所需的尺寸范围内进行设计和原型制作，并使用临床前台式和动物模型验证各种血块大小、形状和机械性能。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 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.