In vivo feasibility of a smart needle ablation treatment for liver cancer

项目摘要 相当数量(约30%-50%)的肝癌由于接近危急状态而无法治愈。 解剖学。微创热消融是治疗这些无法治愈的实体肿瘤的一种很有前途的方法。如果 准确地说，消融手术提供了传统手术的治疗效果，患者风险更低， 临床医生的时间和总成本。然而，现有的消融技术并不能提供必要的精度。 消融工具不提供以下方面的反馈：(1)探头是否已准确放置在 肿瘤，(2)如果肿瘤已经完全破坏，或(3)如果周围的健康组织已经留下 完好无损。由于缺乏精确度和反馈，消融术目前不能用于治疗邻近的肿瘤。 关键解剖学。 针对这些目前无法治愈的癌症，一种建议的解决方案是一种超精密的消融针，嵌入 在其顶端安装了高分辨率的超声波传感器。这些传感器将提供多种好处：帮助临床医生 通过对肿瘤相对于针进行成像来正确放置设备，将治疗能量传递到 通过聚焦精确定位，并通过检测 组织中的热变化--所有这些都不需要大型成像系统。这项创新将使 外科医生以所需的精度完成消融，即使是最难触及的癌症也能治疗。 该第一阶段SBIR计划将展示小规模超声换能器的能力 在活体猪模型中精确控制关键解剖结构(如动脉)附近的消融 通过三个具体目标：(1)优化先前开发的基于超声的消融区 基于深度学习和物理模拟的体外肝组织评估，(2)消融区 活体猪肝模型的评估，以及(3)活体闭合消融区的演示 近临界解剖(肝动脉)的控制。这一阶段的完成将展示关键技术 在一项试验性动物研究中，第二阶段的工作将解决关键的发展里程碑，以 预期的2类设备的商业化(通过新星监管途径获得批准)。

Project Summary A significant number (~30-50%) of liver cancers have no curative treatments due to their proximity to critical anatomy. Minimally invasive thermal ablation is a promising treatment for these untreatable solid tumors. If delivered precisely, ablations offer the treatment efficacy of traditional surgery with lower patient risk, clinician time, and overall cost. Existing ablation technology, however, does not offer the necessary precision. Ablation tools do not provide feedback on (1) whether or not the probe has been accurately placed within the tumor, (2) if the tumor has been completely destroyed, or (3) if surrounding healthy tissue has been left intact. Because of this lack of precision and feedback, ablation cannot currently be used to treat tumors near critical anatomy. A proposed solution to these currently untreatable cancers is an ultraprecise ablation needle, embedded with high-resolution ultrasound sensors at its tip. These sensors will provide multiple benefits: aiding the clinician in placing the device correctly by imaging the tumor relative to the needle, delivering the treatment energy to a precise location through focusing, and providing real-time monitoring of the procedure by detecting the thermal changes in tissue-all without the need for a large imaging system. This innovation will allow surgeons to complete an ablation with the required precision to treat even the most difficult-to-reach cancers. This Phase 1 SBIR proposal will demonstrate the capabilities of small-scale ultrasound transducers to precisely control ablations near critical anatomical structures (e.g., arteries) in an in vivo porcine model through three specific aims: (1) optimization of previously developed ultrasound-based ablation zone estimation in ex vivo liver tissue using deep learning and physics-based simulations, (2) ablation zone estimation in an in vivo porcine liver model, and (3) demonstration of in vivo closed-loop ablation zone control near critical anatomy (artery in liver). Completion of this phase will demonstrate the key technology in a pilot animal study, where Phase 2 work would address critical development milestones to commercialization for an anticipated Class 2 device (approval via de nova regulatory pathway).