Improved Esophageal Safety in Atrial Fibrillation Elimination

项目摘要 SBIR提案的总体目标是开发一种新的设备，使房颤（AF）消融更容易 通过降低食管损伤的风险进行手术。房颤是一种常见的慢性疾病， 心律不齐，可以通过应用射频能量或冷冻消融敏感的 通过左心房的肺静脉的内膜表面的部分。这件事的复杂性 手术包括损伤食管，食管位于薄壁左心房的正后方。损伤 其范围可从食管腔中的无症状溃疡，到罕见但灾难性的心房食管 瘘管（AEF），随后发生卒中和死亡。目前，避免这些并发症的方法包括 避免在食管1cm范围内消融，并监测食管温度。但大多数 患者的解剖学排除了避免在食管的一厘米内进行消融。温度 监测和避免超过某个温度阈值可以延长该过程并降低 手术成功率。事实上，必须放弃的手术率很高，因为 相对于消融部位的食管产生不可接受的高损伤风险。在我们的医生 根据合作者在2016年的实践，19%（41/218）的肺静脉隔离手术不完整 由于接近食道而隔离至少一条静脉。很明显，目前的技术，以保护 消融术期间的食管是初级的，没有专门制造的器械获得FDA批准。 批准该适应症。 BioTex已获得德克萨斯心脏研究所和贝勒医学院的许可， 设计用于控制食管远离左心房和肺静脉的变形的装置， 以及加强温度监测，以提高房颤消融术的安全性和有效性 程序.该快速通道提案的目标是构建功能齐全的原型， 试验，进行试点动物研究，证明减少食管损伤的发生率， 射频消融，完成器械的最终设计，完成所有要求的确认，并获得 监管营销许可。我们预计这种新方法将很容易取代现有的 食管温度监测方法，并对患者的安全有重大影响，并允许 显著提高手术效率和节省医疗保健成本。

Project Summary The overall goal of this SBIR proposal is to develop a novel device to allow easier atrial fibrillation (AF) ablation procedures by mitigating risks for esophageal injury. Atrial fibrillation is the most common chronic disease of heart rhythm, and can be treated with application of radiofrequency energy or cryo to ablate susceptible portions of the endocardial surface of the pulmonary veins through the left atrium. Complications of this procedure include injury to the esophagus, which lies immediately posterior to the thin walled left atrium. Injury can range from asymptomatic ulcerations in the esophageal lumen, to rare, but catastrophic atrioesophageal fistula (AEF) with subsequent stroke and death. Currently, methods to avoid these complications include avoiding ablation within 1cm of the esophagus, and esophageal temperature monitoring. However, most patients’ anatomy precludes avoiding ablation within one centimeter of the esophagus. Temperature monitoring and avoiding exceeding a certain temperature threshold can prolong the procedure and decreases procedural success rates. In fact a significant high rate of procedures must be aborted because the position of the esophagus relative to the ablation site creates unacceptably high risk for injury. In our physician collaborator’s practice in 2016, 19% (41 of 218) of pulmonary vein isolation procedures had incomplete isolation of at least one vein due to proximity of the esophagus. It’s clear that current techniques to protect the esophagus during ablation procedures are rudimentary, and no purpose-built device has received FDA approval for this indication. BioTex has licensed from the Texas Heart Institute and Baylor College of Medicine to create the first ever device designed for controlled deformation of the esophagus away from the left atrium and pulmonary veins as well as enhanced temperature monitoring to improve the safety and efficacy of atrial fibrillation ablation procedures. The objective of this Fast Track proposal is to build fully functional prototypes, conduct benchtop testing, perform pilot animal studies demonstrating reduction of the rate of esophageal injury during radiofrequency ablation, complete a final design of the device, complete all required validations, and obtain regulatory marketing clearances. We anticipate this novel approach will be an easy replacement for existing esophageal temperature monitoring methods, and have a significant impact on patient safety and allow significant improvements in procedure efficiency and health care cost savings.