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.

该SBIR I期项目的更广泛/商业影响是开始验证一种新型的高强度集中超声（HIFU）设备，以微创治疗脑肿瘤。当前的护理标准是一种高度侵入性的颅骨切除术，不仅会冒着感染，不受控制的出血和对健康组织的损害，而且术后恢复延长。尽管已经开发了微创激光消融工具，但它们要求将探针直接插入目标，这仍然有可能出血和破坏组织。此外，虽然可用于其他条件的最低侵入性HIFU工具，但需要新技术来解决更遥远的焦点并说明大脑中组织特异性效应。该设备的设计为：1）减少感染，出血和组织偶然损害的风险； 2）减少工作时间（因此是麻醉时间）； 3）通过促进更快的康复和改善美学来改善患者的生活质量。目标可寻址市场估计近1美元，一次性套件和维护/升级每年额外的283 m。这个SBIR I期项目正在开发一种新型的高强度聚焦超声（HIFU）设备，该设备为颅骨瓣切除术提供了微创替代方案，以去除脑肿瘤。该技术的关键区分优势是：1）通过在头骨上的微创毛刺孔中插入的探针，与颅皮瓣手术相比，切口大小要小得多； 2）HIFU的使用，可以将其聚焦在距传感器尖端距离的距离上（而无需将尖端直接插入目标）。要解决的主要技术障碍是1）设计一个微型的治疗超声传感器，以使安全插入大脑，同时保持与较大的传感器相似的声学特性； 2）包括将HIFU焦点引导到消融复杂几何形状的较大目标的功能。为了实现这些目标，该项目将：1）创建一个数字模型，以使现有的原型微型化，该原型保持声学性能并整合HIFU转向功能； 2）制造一个物理原型，与预测的声功率能力相匹配； 3）在幻影材料和人尸体大脑中显示原型的概念验证功能。如果成功的话，最终的可交付方式将是准备临床前验证的原型。该奖项反映了NSF的法定任务，并且使用基金会的知识分子优点和更广泛的影响审查标准，被认为值得通过评估来获得支持。