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

这一小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种用于治疗静脉血栓栓塞（VTE）的新型系统，静脉血栓栓塞是患者深静脉或肺动脉中的凝块，可更有效地阻断血流。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。尽管有现代治疗和程序，但超过一半的被诊断患有VTE的患者将遭受长期并发症，包括血栓后综合征，导致功能残疾和在诊断后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循环来提高机械血栓切除术的临床有效性，从而改善患者的预后并降低长期患者护理成本。该小型企业创新研究（SBIR）I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用于固定和清除血栓的可行性。该技术旨在有效清除凝块，同时对血管无创伤，失血量最小，以显著改善现有的凝块截留或清除方法。 活动范围包括开发第一代原型，并证明原型能够摄取大量凝块，而不会堵塞或损坏其他血管结构。该设备将被设计和原型的尺寸内需要适合在临床上接受的导管尺寸和验证使用临床前实验台和动物模型在各种凝块的大小，形状和机械property.This奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的智力价值和更广泛的影响审查标准的支持。

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.