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

SBIR 第二阶段：用于创建精确定向消融区域的微波消融系统

基本信息

批准号：
1951186
负责人：
Austin Pfannenstiel
金额：
$ 74.96万
依托单位：
Precision Microwave Inc.
依托单位国家：
美国
项目类别：
Standard Grant
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-01 至 2023-12-31
项目状态：
已结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=1951186&HistoricalAwards=false
关键词：
SBIR Phase II Microwave ablation

项目摘要

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.

该SBIR II期项目提案的更广泛/商业影响继续开发有向微波炉（MWA）系统。在MWA期间，医生使用图像指导将薄针状涂抹器插入靶肿瘤中，然后将嵌入涂抹器尖端中的微波天线供应，以加热和杀死肿瘤。 MWA对于由于肿瘤的位置或健康状况不佳而导致的较差的候选手术或其他要求的疗法（例如化学疗法或放射治疗）的癌症患者尤其重要。当前所有可用的MWA系统都只能产生以涂抹器轴为中心的大致球形或泪珠形治疗区，该处理区不适合治疗位于关键解剖结构或不规则形状靶标附近的肿瘤。这种局限性通常会使医生不难选择不足和疾病复发，或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威胁生命的并发症。定向MWA将使物理可以将涂抹器放在肿瘤旁边，并将热量直接朝目标并远离近敏感的时间。由定向的MWA实现的新临床技术可以促进更快，更安全，更有效，更低的成本处理局部肿瘤，并有可能拓宽可以以微观侵入性的方式进行的疾病范围，因为微波天线通常需要物理上的大型结构，需要实现高度的方向性，并具有高度的适用性，并具有适用于小型直径（2.0 mmmetor））（2.0mmmmmme））需要使用新颖的设计方法，制造过程和材料。该阶段II阶段项目中的技术工作包括：1）原型消融涂抹器和传输电缆中心的工业化设计，以及相关的制造和组装过程开发，以提高质量和临床可用性； 2）测试和表征临床输送参数，并开发一种算法，该算法为创建可定制治疗区的治疗计划提供了信息； 3）开发可编程的多渠道MW生成器平台，可自定义控制能源输送参数，4）详细的系统集成以及体内系统性能评估和对开发治疗计划和给药指南的表征和表征。我们将采用一种整合多物理计算模型，离体组织中的台式实验以及在猪肝和肾脏中的体内实验来设计，优化和验证我们的施用者以及集成的微波炉消融系统的方法。这项研发工作的目的是完成临床上可行的定向微波消融系统的技术设计。该奖项反映了NSF的法定任务，并通过使用基金会的知识分子优点和更广泛的影响评估标准来评估值得支持。