SBIR Phase I: Smart needle for precise tumor ablation

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.