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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.

SBIR二期项目的更广泛/商业影响建议继续开发定向微波消融（MWA）系统。在MWA过程中，医生利用图像引导将一个细针状的涂抹器插入目标肿瘤，然后激活嵌入在涂抹器尖端的微波天线来加热并杀死肿瘤。对于由于肿瘤位置或健康状况不佳而不适合手术或其他体力要求较高的治疗方法（如化疗或放射治疗）的大量癌症患者，MWA尤其重要。目前所有可用的MWA系统都只能产生以涂抹器轴为中心的大致球形或泪滴状的治疗区，这不适用于治疗靠近关键解剖结构或不规则形状目标的肿瘤。这种限制往往使医生面临一个艰难的选择，是冒着治疗不足和疾病复发的风险，还是冒着过度治疗和损害关键健康解剖结构的风险，这可能导致疼痛或危及生命的并发症。定向MWA将允许医生将涂抹器放置在肿瘤旁边，并将热量引导到目标，远离附近的敏感组织。通过定向MWA实现的新的临床技术可以促进更快、更安全、更有效和更低成本的局部肿瘤治疗，并有可能扩大以微创方式治疗的疾病范围。由于微波天线通常需要较大的物理结构来实现高度的指向性，因此开发适合微创治疗的小直径（2.0 mm）涂抹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。本二期项目的技术工作包括：1)消融应用器和传输电缆集线器原型的工业化设计，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)临床递送参数的测试和表征，并开发一种算法，为创建可定制治疗区域的治疗计划提供信息；3)开发可编程多通道兆瓦发电机平台，提供可定制的能量输送参数控制；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。我们将采用多物理场计算模型、离体组织台式实验和猪肝和肾脏体内实验相结合的方法来设计、优化和验证我们的涂抹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。该奖项反映了美国国家科学基金会的法定使命，并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。