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

SBIR一期项目的更广泛/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。目前的治疗标准是高度侵入性的颅瓣切除术，这不仅有感染、无法控制的出血和对健康组织的损害的风险，而且术后恢复时间也很长。虽然微创激光消融工具已经开发出来，但它们需要将探针直接插入目标，这仍然有出血和损伤组织的风险。此外，虽然微创HIFU工具可用于其他疾病，但需要新技术来解决更远的焦点并解释大脑中组织特异性的影响。该设备旨在：1)降低感染、出血和组织意外损伤的风险；2)减少手术（和麻醉）时间；3)提高患者的生活质量，促进更快的恢复和改善美观。目标可寻址市场估计接近10亿美元，每年还有2.83亿美元用于一次性套件和维护/升级。这个SBIR一期项目正在开发一种新型的高强度聚焦超声（HIFU）设备，提供了一种微创替代颅皮瓣切除脑肿瘤的方法。该技术的主要优势在于：1)探头通过颅骨上的微创钻孔插入，与颅瓣手术相比，切口尺寸要小得多；2) HIFU的使用，它可以在距离换能器尖端一定距离的地方聚焦（不需要将尖端直接插入目标）。需要解决的主要技术障碍是1)设计一种小型化的治疗性超声换能器，使其能够安全插入大脑，同时保持与大型换能器相似的声学特性；2)包括引导HIFU焦点消融复杂几何结构的更大目标的能力。为了实现这些目标，该项目将：1)创建一个数字模型，使现有原型机小型化，保持声学性能并集成HIFU转向功能；2)制作与预测声功率能力相匹配的物理原型；3)展示原型在幻影材料和人类尸体大脑中的概念功能验证。如果成功，最终交付的产品将是临床前验证的原型。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/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.