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

STTR 第一阶段：用于消融脑肿瘤的微创、高强度聚焦超声装置

• 批准号: 1938939
• 负责人: Nao Gamo
• 金额: $ 22.5万
• 依托单位: NEUROSONICS MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938939&HistoricalAwards=false
• 关键词: STTR; Phase; Minimally; Invasive; Intensity

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.

SBIR第一阶段项目的更广泛/更广泛的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侵袭性的颅骨瓣切除，这不仅有感染、失血和健康组织受损的风险，而且术后恢复时间长。尽管已经开发了微创激光消融工具，但它们需要将探头直接插入目标，这仍然有出血和组织损伤的风险。此外，虽然微创HIFU工具可用于其他情况，但需要新技术来解决更远的焦点，并考虑到大脑中组织特有的影响。这种设备的设计目的是：1)减少感染、出血和组织意外损伤的风险；2)减少手术(从而减少麻醉)时间；3)通过促进更快的康复和改善美学来提高患者的生活质量。目标潜在市场估计接近10亿美元，每年用于一次性套件和维护/升级的额外资金为2.83亿美元。这个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，提供了一种替代颅骨瓣切除脑肿瘤的微创替代方案。这项技术的主要区别优势在于：1)通过颅骨微创钻孔插入探头，与颅骨瓣手术相比，允许的切口尺寸小得多；以及2)使用HIFU，它可以在距离换能器尖端一段距离处聚焦(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)设计一种微型治疗性超声换能器，以允许安全地插入大脑，同时保持与较大换能器相似的声学特性；以及2)包括引导HIFU焦点以消融复杂几何结构的较大目标的能力。为了实现这些目标，该项目将：1)创建一个数字模型，将保持声学性能并集成HIFU转向能力的现有原型微型化；2)制造一个与预测的声功率能力相匹配的物理原型；以及3)在幻影材料和人类身体大脑中展示原型的概念验证功能。如果成功，最终交付的成果将是一个可用于临床前验证的原型。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。