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.
