SBIR Phase I: Smart needle for precise tumor ablation

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是使医生能够通过开发智能手术针来治疗以前无法治疗的癌症肿瘤。在许多临床情况下，由于肿瘤靠近关键解剖结构，患者无法接受根治性手术;例如，肝癌的中央胆管。在这些情况下，患者被迫在许多结果不佳且副作用显著的非治愈性治疗之间做出决定。早期肿瘤治疗的创新将为服务不足的社区和患者群体扩大治疗选择。例如，肝癌不成比例地影响美国原住民，西班牙裔和非洲裔美国人，多达30%至66%的患者从未接受过任何治疗。其中一个原因是，外科治疗需要大量的手术室基础设施（例如，三维医学成像）来提供高质量的结果;不幸的是，这些设施集中在研究医院，并且访问并不普遍。在这里开发的技术将针对这些肿瘤，并将适用于超过600，000患者在美国每年患有肝癌，肾癌，肺癌和乳腺癌。这个小企业创新研究第一阶段项目将证明小尺寸传感器的可行性，将消融技术转化为所有癌症肿瘤的一线治疗。通过将成像传感器放置在针尖上，该设备可以克服使用传统图像引导时遇到的性能限制。这种增强的性能与实时图像分析相结合，可以感测各种组织中的温度变化。感应温度变化的能力将与基于针尖的能量输送相结合，以提供一体化闭环消融器械，并能够治疗以前无法治疗的肿瘤。 该项目将展示深度学习技术的应用，结合基于物理的模拟，以实现精确的消融监测。 随后，消融监测将与消融控制相结合，以测试在离体组织中进行精确闭环消融的可行性，并具有足够的准确度，可用于未来的临床实施。该奖项反映了NSF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 impact/commercial potential of this Small Business Innovation Research (SBIR) Phase 1 project is to enable doctors to treat previously untreatable cancerous tumors through the development of a smart surgical needle. There are many clinical situations in which a patient cannot receive curative surgery because of the proximity of the tumor to critical anatomy; for example, the central bile duct in liver cancer. In these cases, patients are forced to decide between a number of non-curative treatments that have poor outcomes and significant side effects. Innovation in early-stage tumor treatments will expand treatment options to under-served communities and patient populations. Liver cancer, for example, disproportionately affects Native Americans, Hispanics, and African-American populations in the US, with as many as 30% to 66% patients never receiving any treatment. One reason is that surgical treatments require significant operating room infrastructure (for example, three-dimensional medical imaging) to provide high-quality outcomes; unfortunately these facilities are concentrated in research hospitals and access is not widespread. The technology developed here will address these tumors, and will apply to the more than 600,000 patients in the US yearly that suffer from cancers of the liver, kidney, lung, and breast.This Small Business Innovation Research Phase I project will demonstrate feasibility of small-size sensors to transform ablation technology into a first-line treatment for all cancerous tumors. By placing imaging sensors onto the tip of a needle, the device can overcome performance limits encountered when using traditional image guidance. This increased performance, in combination with real-time image analysis, can sense temperature variation in a variety of tissues. The ability to sense temperature variation will be combined with needle tip-based energy delivery to provide an all-in-one closed loop ablation device, with the capability to treat previously untreatable tumors. This project will demonstrate the application of deep-learning techniques, combined with physics based simulations, to enable precision ablation monitoring. Subsequently the ablation monitoring will be combined with ablation control to test the feasibility of precise closed-loop ablation in ex vivo tissue with sufficient accuracy for future clinical implementation. This foundational work will then guide the development of the desired needle probe embodiment.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.