A Novel Radiometry‐Guided Ablation Catheter to Reliably Treat Barrett's Esophagus

摘要 在根除食道癌的斗争中，Symple Surgical的目标是开发一种低成本、多功能的消融系统 治疗巴雷特食道(BE)。BE是胃-食道反流病(GERD)的严重并发症 影响了大约40%的美国人口。在超过1.6%的人中，长期暴露在酸反流中会诱发BE、AN 可发展为致命性食管腺癌(EAC)的食道上皮异常。关联的 随着肥胖，如GERD和BE，EAC的发病率近年来比任何癌症都增长得更快。 目前的内窥镜监测可以发现癌前病变，这通常是用射频治疗的 消融(RFA)，在各大医院提供。然而，RFA需要多年的程序，具有各种不同的 昂贵的靶标专用喷雾器。更重要的是，RFA治疗主要消融表面上皮， 通常使潜在的癌前细胞完好无损地留在粘膜层更深的地方。考虑到致命病毒的崛起 因此，克服目前的总体成本和程序挑战是食道癌治疗的迫切需要。 因此，我们建议将可靠、通用的加热机制与实时准确的热反馈相结合 变成了一种新型的低成本消融设备。我们的DirectAblate Grizzly™微波消融导管技术 采用双用途微波天线，具有独特的优势：i)可靠的消融区 完整的粘膜；ii)实时剂量测量和通过被动收集来自 感知音量。近期目标是在我们的BE微波消融导管中实现辐射传感 并在真实的幻影、体外组织和猪体内模型中测试该系统。长期目标 是通过提高Be消融的可靠性和精确度来显著降低EAC的发生率 细胞靶向和实时热剂量学。我们的方法的基本原理是，低成本的尖端移动 通信技术可用于具有辐射反馈的负担得起的微波消融系统。 我们的基本假设是，通过结合创新的微波加热和热传感技术 到一个单一的一次性导管，我们可以最佳和负担得起的消融是癌前病变。为了证明我们的 假设，我们提出这些具体目标：1)将多波段辐射传感集成到多功能消融中 Be消融过程中持续准确控制导管；2)测试准确反馈微波的能力 模拟体模、体外猪食道组织和活体猪的加热。要证明的具体里程碑 成功的有：1)内窥镜微波消融导管中放射硬件的优化集成；2) 从食道表面重建多个深度温度的算法；3)可靠加热的验证 在几种临床方案的真实BE模型中；4)体外消融质量的初步评估 和活体猪的食道。预期的结果是一种加热模式可控的新型Be消融导管 和实时热剂量计。我们预计Grizzly™系统也将在低成本地区得到广泛采用。 资源设置，以可靠地移除癌前病变，最终减少食道癌死亡。

ABSTRACT In the fight to eradicate esophageal cancer, Symple Surgical aims to develop a low-cost versatile ablation system for Barrett's esophagus (BE). BE is a serious complication of gastro-esophageal reflux disease (GERD) which affects ~40% of the US population. In more than 1.6% of people, chronic exposure to acid reflux induces BE, an esophageal epithelium abnormality that can develop into lethal esophageal adenocarcinoma (EAC). Associated with obesity, as GERD and BE, EAC is increasing in incidence more rapidly than any cancer in recent years. Current endoscopic monitoring can detect precancerous BE, which is treated usually with radiofrequency ablation (RFA), available in major hospitals. However, RFA requires multiple yearly procedures with a variety of expensive target-specific applicators. More importantly, RFA treatments ablate mostly the surface epithelium, often leaving potentially precancerous cells intact deeper in the mucosal layer. Considering the rise of deadly esophageal cancer, overcoming current overall cost and procedural challenges is thus an urgent clinical need. We thus propose to integrate reliable and versatile heating mechanism with real-time accurate thermal feedback into a novel low-cost ablation device. Our DirectAblate GRIZZLY™ Microwave Ablation Catheter technology uses a dual–purpose microwave antenna with unique advantages: i) dependable ablation zone targeting the complete mucosa; ii) real-time dosimetry and guidance by passively collecting thermal radiation from multiple sensing volumes. The immediate goal is to implement radiometric sensing in our BE microwave ablation catheter and test the system in realistic phantoms, in ex-vivo tissues and in a swine in-vivo model. The long-term objective is to significantly reduce EAC incidence by improving BE ablation reliability and accuracy with precise abnormal cell targeting and real-time thermal dosimetry. The rationale for our approach is that low-cost cutting-edge mobile communication technologies can be used for affordable microwave ablation systems with radiometric feedback. Our underlying hypothesis is that by combining innovative microwave heating and thermal sensing technologies into a single disposable catheter, we can optimally and affordably ablate BE precancerous lesions. To prove our hypothesis, we propose these specific aims: 1) Integrate multiband radiometric sensing into a versatile ablation catheter for continuous accurate control during BE ablation; 2) Test the ability to accurately feedback microwave heating in realistic phantoms, ex-vivo pig esophageal tissue and in-vivo swine. Specific milestones to prove success are: 1) Optimized integration of radiometric hardware in an endoscopic microwave ablation catheter; 2) Algorithm to reconstruct temperature at multiple depths from esophageal surface; 3) Validation of reliable heating in realistic BE phantom models for several clinical scenarios; 4) Initial assessment of ablation quality in ex-vivo and in-vivo pig esophagi. The expected outcome is a new BE ablation catheter with controllable heating pattern and real-time thermal dosimetry. We anticipate that GRIZZLY™ system will be widely adopted also in low- resource settings to remove reliably precancerous BE lesions, ultimately reducing esophageal cancer deaths.