STTR Phase I: Minimally Invasive, High-Intensity Focused Ultrasound Device for Ablation of Brain Tumors

该SBIR第一阶段项目的更广泛/商业影响是开始验证一种用于脑肿瘤微创治疗的新型高强度聚焦超声（HIFU）设备。目前的护理标准是高度侵入性的颅瓣切除术，这不仅有感染、不受控制的出血和对健康组织的损伤的风险，而且还延长了术后恢复时间。虽然已经开发出微创激光消融工具，但它们需要将探针直接插入目标，这仍然存在出血和损伤组织的风险。此外，虽然微创HIFU工具可用于其他条件，但需要新技术来解决更远的焦点并考虑大脑中的组织特异性效应。该器械设计用于：1）降低感染、出血和组织意外损伤的风险; 2）减少手术（以及因此麻醉）时间;以及3）通过促进更快的恢复和改善的美观来提高患者的生活质量。目标可寻址市场估计接近10 B美元，每年还有2.83亿美元用于一次性套件和维护/升级。该SBIR第一阶段项目正在开发一种新型的高强度聚焦超声（HIFU）设备，为颅骨瓣切除术提供一种微创替代方案，以切除脑肿瘤。该技术的关键差异化优势在于以下组合：1）通过颅骨中的微创钻孔插入的探针，与颅骨瓣手术相比，允许更小的切口尺寸;以及2）使用HIFU，其可以在距离换能器尖端一定距离处聚焦（无需将尖端直接插入目标）。要解决的主要技术障碍是：1）设计一种小型化治疗超声换能器，以允许安全插入大脑，同时保持与较大换能器相似的声学特性; 2）包括控制HIFU焦点以消融复杂几何形状的较大目标的能力。为实现这些目标，该项目将： 1)创建数字模型以模拟现有原型，该原型保持声学性能并集成HIFU转向能力; 2）制造与预测的声功率能力匹配的物理原型;以及3）在体模材料和人类尸体大脑中显示原型的概念验证功能。如果成功的话，最终的成果将是一个准备好进行临床前验证的原型。这个奖项反映了NSF的法定使命，并被认为是值得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的支持。

The broader/commercial impact of this SBIR Phase I project is to start validating a novel high-intensity focused ultrasound (HIFU) device for minimally invasive treatment of brain tumors. The current standard of care is a highly invasive cranial flap resection, which not only risks infection, uncontrolled bleeding, and damage to healthy tissue, but also has prolonged post-operative recovery. Although minimally invasive laser ablation tools have been developed, they require the probe to be inserted directly into the target, which still risks bleeding and damaging tissue. Furthermore, while minimally invasive HIFU tools are available for other conditions, new technologies are needed to address more distant focal points and account for tissue-specific effects in the brain. This device is designed to: 1) reduce risks of infection, bleeding, and incidental damage to tissue; 2) reduce operating (and hence anesthesia) time; and 3) improve quality of life for patients by promoting faster recovery and improved aesthetics. The target addressable market is estimated to be nearly $1 B, with an additional $283 M per year for disposable kits and maintenance/upgrades. This SBIR Phase I project is developing a novel high-intensity focused ultrasound (HIFU) device offering a minimally invasive alternative to cranial flap resections to remove brain tumors. The key differentiating advantage of this technology is in the combination of: 1) a probe that is inserted through a minimally invasive burr hole in the skull, allowing a much smaller incision size compared to a cranial flap surgery; and 2) the use of HIFU, which can be focused at a distance from the tip of the transducer (without inserting the tip directly into the target). The main technical hurdles to be addressed are to 1) design a miniaturized therapeutic ultrasound transducer to allow safe insertion into the brain while maintaining similar acoustic properties to a larger transducer; and 2) include capabilities to steer the focus of HIFU to ablate larger targets of complex geometry. To achieve these goals, the project will: 1) create a digital model to miniaturize an existing prototype that maintains acoustic performance and integrates HIFU steering capabilities; 2) fabricate a physical prototype matching the predicted acoustic power capabilities; and 3) show proof-of-concept functionality of the prototype in a phantom material and human cadaver brain. If successful, the final deliverable will be a prototype ready for preclinical validation.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.