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

摘要 在根除食管癌的斗争中，Symple Surgical旨在开发一种低成本的多功能消融系统 Barrett食管（BE）BE是胃食管反流病（GERD）的严重并发症， 影响了约40%的美国人口。在超过1.6%的人中，长期暴露于酸反流会诱发BE， 食管上皮异常可发展为致死性食管腺癌（EAC）。关联 随着肥胖，如GERD和BE，近年来EAC的发病率增长速度比任何癌症都快。 目前的内窥镜监测可以检测到癌前BE，通常采用射频治疗 射频消融（RFA），在大医院可用。然而，RFA需要每年多次手术， 昂贵的特定目标施用器。更重要的是，RFA治疗主要消融表面上皮， 通常在粘膜层更深处留下潜在的癌前细胞。考虑到致命的 因此，克服当前的总体成本和程序挑战是临床上的迫切需要。 因此，我们建议将可靠和通用的加热机制与实时准确的热反馈相结合 一种新型的低成本消融装置。我们的Directorate GRIZZLY ™微波消融导管技术 使用具有独特优势的两用微波天线：i）可靠的消融区域， 完整的粘膜; ii）通过被动收集来自多个组织的热辐射进行实时剂量测定和指导 感测体积。近期目标是在我们的BE微波消融导管中实现辐射传感 并在真实的体模、离体组织和猪体内模型中测试该系统。长期目标 通过提高BE消融的可靠性和准确性， 细胞靶向和实时热剂量测定。我们的方法的基本原理是，低成本的尖端移动的 通信技术可以用于具有辐射反馈的可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 一次性导管，我们可以最佳和经济地消融BE癌前病变。来证明我们 假设，我们提出了这些具体的目标：1）将多波段辐射传感集成到通用消融中 BE消融期间持续准确控制的导管; 2）测试准确反馈微波的能力 在真实体模、离体猪食管组织和体内猪中加热。具体的里程碑来证明 成功之处在于：1）在内窥镜微波消融导管中优化集成了辐射测量硬件; 2） 从食管表面重建多个深度温度的算法; 3）可靠加热的验证 在几种临床场景的真实BE体模模型中; 4）体外消融质量的初步评估 和体内猪食管。预期结果是具有可控加热模式的新型BE消融导管 和实时热剂量测定。我们预计GRIZZLY ™系统也将在低成本环境中广泛采用。 资源设置，以消除可靠的癌前BE病变，最终减少食管癌死亡。

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.