SBIR Phase II: Microwave ablation system for creating precision directed ablation zones

Precision Microwave Inc., Manhattan KS

Investigators

Abstract

The broader/commercial impact of this SBIR Phase II project proposes continued development of a directional microwave ablation (MWA) system. During MWA, doctors use image guidance to insert a thin needle-like applicator into a target tumor and then energize the microwave antenna embedded in the applicator’s tip to heat and kill the tumor. MWA is especially important to the large population of cancer patients who are poor candidates for surgery or other physically demanding therapies, such as chemotherapy or radiation therapy, due to tumor location or poor health. All currently available MWA systems are only capable of producing a roughly spherical or teardrop-shaped treatment zone centered on the axis of the applicator, which is not suitable for treating tumors located near critical anatomy or irregularly shaped targets. This limitation often leaves doctors with a difficult choice of risking undertreatment and disease recurrence or risking overtreatment and damage to critical healthy anatomy that may cause pain or life-threatening complications. Directional MWA would allow the physician to instead place the applicator alongside the tumor and direct heat toward the target and away from nearby sensitive tissues. New clinical techniques enabled by directional MWA could facilitate faster, safer, more effective, and lower cost treatment of localized tumors, and potentially broaden the range of diseases that could be treated in a minimally invasive manner. As microwave antennas typically require physically large structures to achieve a high degree of directivity, developing a small diameter (<2.0 mm) applicator suitable for minimally invasive treatments is technically challenging and requires the use of novel design methods, fabrication processes, and materials. Technical work in this Phase II projects includes: 1) Industrialized design of the prototype ablation applicator and transmission cable hub, and associated fabrication and assembly process development to improve quality and clinical usability; 2) Testing and characterization of clinical delivery parameters, and developing an algorithm that informs treatment planning for the creation of customizable treatment zones; 3) Development of a programmable multi-channel MW generator platform, affording customizable control of energy delivery parameters, and 4) Detailed system integration and in vivo system performance assessment and characterization to develop treatment planning and dosing guidelines. We will employ an approach integrating multiphysics computational models, benchtop experimentation in ex vivo tissue, and in vivo experiments in porcine liver and kidney to design, optimize, and validate our applicators and integrated microwave ablation system. The goal of this R&D effort is to complete the technical design of a clinically viable directional microwave ablation system. 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.