SBIR Phase I: A Versatile Endovascular Lattice for the Treatment of Saccular Aneurysms

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是引入一种治疗颅内动脉瘤的新方法。脑动脉瘤影响约2%的美国人口。脑动脉瘤破裂占非外伤性蛛网膜下腔出血的75-80%，约50%的病例死亡率高。由于动脉瘤破裂的严重后果，迫切需要新的治疗方法。这个项目将开发一种产品来帮助脑动脉瘤的愈合。这项拨款的预期结果是生产出可行性和可用性最佳的动脉瘤装置。在临床应用方面，最佳的可行性转化为提高闭塞率和动脉瘤愈合。对于医生来说，可用性的提高会导致设备偏好，缩短培训时间和缩短手术时间。这个小型企业创新研究项目（SBIR）的第一阶段项目推进了一种解决方案的翻译，该解决方案考虑了动脉瘤的形状，这是一种不同的概念，将该产品与其他囊内血流干扰物区分开来。这些特殊的形状符合脑动脉瘤的几何形状，提供更好的配合。该项目将解决三个目标：1)增强产品系统的安全性和有效性。在这个目标中，将系统地测试产品的设计特性，以达到最佳性能。2)测试产品的可用性和功能，同时开发以用户为中心的尺寸矩阵。神经外科医生将在硅胶模型中测试该产品。用户将根据性能对系统进行评分。流动动力学也将被测量。3)描述植入和体内下游效应。将在兔子身上进行研究。如果成功，结果将用作人体试验的支持证据。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 to introduce a new approach to cranial aneurysm treatment. Brain aneurysms affect ~2% of United States population. Ruptured brain aneurysms accounts for 75-80% of non-traumatic subarachnoid hemorrhage which are associated with high mortality rate in ~50% of cases. Due to serious consequences of aneurysm rupture, there is a pressing need for new treatments. This project will develop a product to aid in the healing of brain aneurysms. The expected outcomes of this grant is the production of the an aneurysm device that is optimal for feasibility and usability. In terms of clinical use, optimal feasibility translates to improved occlusion rates and aneurysm healing. For physicians, improved usability leads to device preference, shortened training time, and shortened procedure time. This Small Business Innovation Research Program (SBIR) Phase I project advances translation of a solution that takes into account the shape of the aneurysm, a different concept that separates this product from other intrasaccular flow disruptors. These specialized shapes conform to the geometry of brain aneurysms, providing better fit. This project will address three objectives: 1) Enhancement of the product system for safety and effectiveness. In this objective, the design characteristics of the product will be systematically tested to achieve optimal performance. 2) Test the product for usability and function, along with development of user focused sizing matrix. Neurosurgeons will test the product in a silicone model. Users will grade the system on performance. Flow dynamics will also be measured. 3) Characterize implantation and downstream effects in vivo. A study in rabbits will be conducted. If successful, results will be used as supporting evidence for human trials.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.