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

该SBIR第II阶段项目的更广泛/商业影响建议继续开发定向微波消融（MWA）系统。在MWA过程中，医生使用图像引导将细针状施用器插入目标肿瘤中，然后激励嵌入施用器尖端的微波天线以加热并杀死肿瘤。MWA对于大量癌症患者尤其重要，这些患者由于肿瘤位置或健康状况不佳而不适合手术或其他身体要求高的治疗，如化疗或放疗。所有目前可用的MWA系统仅能够产生以施用器的轴线为中心的大致球形或泪珠形的治疗区，这不适合于治疗位于关键解剖结构附近的肿瘤或不规则形状的目标。这种限制往往使医生面临一个困难的选择，要么冒着治疗不足和疾病复发的风险，要么冒着过度治疗和对关键健康解剖结构的损害的风险，这可能会导致疼痛或危及生命的并发症。定向MWA将允许医生将施源器放置在肿瘤旁边，并将热量导向目标并远离附近的敏感组织。通过定向微波消融实现的新临床技术可以促进局部肿瘤的更快、更安全、更有效和更低成本的治疗，并且潜在地拓宽可以以微创方式治疗的疾病范围。由于微波天线通常需要物理上大的结构来实现高度的方向性，开发适用于微创治疗的小直径（2.0mm）的涂药器在技术上具有挑战性，并且需要使用新颖的设计方法、制造工艺和材料。该二期项目的技术工作包括：1）原型消融器和传输电缆集线器的工业化设计，以及相关的制造和组装工艺开发，以提高质量和临床可用性; 2）临床输送参数的测试和表征，并开发一种算法，为创建可定制的治疗区域提供治疗计划; 3）开发可编程多通道MW发生器平台，提供能量输送参数的可定制控制，以及4）详细的系统集成和体内系统性能评估和表征，以制定治疗计划和给药指南。我们将采用集成多物理场计算模型、离体组织台式实验以及猪肝脏和肾脏体内实验的方法来设计、优化和验证我们的施源器和集成微波消融系统。这项研发工作的目标是完成临床可行的定向微波消融系统的技术设计。该奖项反映了NSF的法定使命，并且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/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.