Circumferential Electrode Array for Radiofrequency Tumor Ablation

描述（由申请人提供）：原发性和转移性肝癌在美国和世界范围内都很常见。肝癌的标准治疗是肝切除术，其中包含肿瘤的部分肝脏被手术切除。然而，只有约20%的患者可以进行手术，对于无法进行手术的患者，射频（RF）消融是一种可接受的治疗方法。在射频消融期间，将电极引入肿瘤中，通过射频电流加热来破坏癌症。目前的射频消融手术有几个缺点，导致治疗不足：（1）单次消融无法充分治疗中等大小的肿瘤（>3.0 cm），（2）靠近大血管的性能不足，以及（3）术中成像不足。我们提出了一种新的肿瘤消融装置，它由一系列围绕肿瘤的电极组成，并从外部引导双极能量，而不是像目前的消融装置那样从内到外加热肿瘤。具有环形电极的装置将在治疗的肿瘤中产生更均匀、更高的温度分布，并克服肝脏内血管的冷却效应。此外，该装置将允许通过单一应用快速治疗大肿瘤，这是当前装置不可能实现的。这将大大降低治疗计划的复杂性，减少大肿瘤治疗的手术时间，并可能降低肿瘤复发率，提高生存率。消融时间将从目前的12-45分钟显著缩短至5分钟以下。此外，还将避免因分散电极加热引起的皮肤灼伤和肿瘤沿沿着针插入通道种植等并发症。公共卫生相关性：如果成功，该项目中提出的设备将允许更有效地治疗无法通过手术治疗的肝癌患者，减少治疗时间并最终提高患者生存率。

DESCRIPTION (provided by applicant): Both primary and metastatic liver cancer is common in the US, and worldwide. The standard treatment for liver cancer is liver resection, where part of the liver containing the tumor is surgically removed. Surgery is however only possible in ~20% of the patients, and Radiofrequency (RF) ablation is an accepted treatment method for patients where surgery is not possible. During RF ablation, an electrode is introduced into the tumor, and the cancer is destroyed by heating via RF current. Current RF ablation procedures have several shortcomings resulting in often insufficient treatment: (1) an inability to adequately treat even moderate sized tumors (>3.0 cm) with a single ablation, (2) inadequate performance close to large vessels, and (3) inadequate intraoperative imaging. We propose a new tumor ablation device that consists of an array of electrodes surrounding the tumor and directing bipolar energy from outside, instead of heating the tumor inside-out, as with current ablation devices. The device with circumferential electrodes will generate a more uniform, higher temperature profile in the treated tumor and overcome the cooling effect of vessels within the liver. Furthermore, the device will allow rapid treatment of large tumors with a single application which is not possible with current devices. This will make treatment planning considerably less complex, reducing procedure time for large tumor treatment, and likely also lower tumor recurrence rate, increasing the survival. Ablation time will be significantly reduced from currently 12-45 min to below 5 min. In addition, complications such as skin burns due to heating of dispersive electrodes and tumor seeding along needle insertion tracts will be avoided. PUBLIC HEALTH RELEVANCE: The device proposed in this project will, if successful, allow more effective treatment of liver cancer patients not treatable by surgery, reducing treatment times and ultimately improving patient survival.