Saline Enhanced Radiofrequency Ablation for Liver Tumors

描述(申请人提供)：肝癌是一个重要的和日益严重的健康问题。在美国，将有超过72,500例结直肠癌转移到肝脏。肝细胞癌在美国也日益受到关注，这主要是由于丙型肝炎的增加。在过去的十年里，美国的肝癌发病率翻了一番，达到17,550例，预计在未来十年还会翻一番。这些患者中的绝大多数将在5年内死亡。目前治疗肝癌的标准是手术切除，但只有大约20%的患者有资格接受这种手术。经皮射频消融是一种可供选择的治疗方法。在这种疗法中，将一个小电极插入肿瘤中，并使用高功率、高频电流加热肿瘤。这种疗法是一种特别有吸引力的切除替代方法，因为它价格低廉，并发症发生率低。然而，这种疗法只对小肿瘤有效--当治疗直径大于3-4厘米的肿瘤时无效。由于一半的患者在最初诊断时肿瘤大于3厘米，而这些较大的肿瘤会降低预期寿命，因此迫切需要一个能够治疗大肿瘤的系统。我们建议完成我们的盐水增强射频消融系统的开发，该系统能够治疗大的肝肿瘤。我们的系统使用射频加热组织，同时通过电极和组织内注射热盐水。生理盐水的细胞外流动将热能传递到组织更深的地方，以治疗比以前可能的更大的体积。我们的技术已经在体内造成了直径8厘米的热损伤。这些处理体积是使用传统射频电极产生的处理体积的20倍。我们将完成我们的治疗系统和针头的设计，并验证其是否符合医疗电气安全标准(EN60601-1)、生物兼容性(ISO-10993)，并将灭菌验证至10(-6)的无菌保证水平(SAL)。然后，我们将在MD安德森癌症中心、路易斯维尔大学、辛辛那提大学和西南医学中心进行一项多中心临床试验。在完成临床试验后，我们将提交并获得510(K)许可，以便在美国销售农奴消融系统。

DESCRIPTION (provided by applicant): Liver cancer is a significant and increasing health concern. In the United States, there will be over 72,500 cases of colorectal cancer metastasized to the liver. Hepatocellular carcinoma (HCC) is also an increasing concern in the United States, primarily due to a rise in hepatitis C. The incidence of HCC in the United States has doubled to 17,550 cases over the last decade, and it is expected to double again over the next ten years. The vast majority of these patients will die within 5 years. The current standard for treating liver cancer is surgical resection, but only about 20% of patients are eligible for this procedure. Percutaneous radiofrequency ablation is one alternative therapy. In this therapy, a small electrode is inserted into the tumor and a high-power, high frequency electrical current heats the tumor. This therapy is a particularly attractive alternative to resection because it is inexpensive and it has a low incidence of complication. However, this therapy is only effective on small tumors-it is ineffective when treating tumors larger than 3-4 cm in diameter. A system capable of treating large tumors is critically needed since half of patients have tumors larger than 3 cm at initial diagnosis, and these larger tumors decrease life expectancy. We propose to complete the development of our saline-enhanced radiofrequency (SERF) ablation system capable of treating large liver tumors. Our system uses radiofrequency heating of tissue with simultaneous injection of hot saline through the electrode and into the tissue. The extracellular flow of saline convects the thermal energy deeper into the tissue to treat larger volumes than previously possible. Our technique has created 8 cm diameter thermal lesions in vivo. These treatment volumes are 20 times as large as those created with conventional RF electrodes. We will complete the design of our therapy system and needle and validate that it complies with medical electrical safety standards (EN60601-1), biocompatibility (ISO-10993), and validate the sterilization to a sterility assurance level (SAL) of 10(-6). We will then carry out a multi-center clinical trial at the MD Anderson Cancer Center, the University of Louisville, the University of Cincinnati and the Southwestern Medical Center. Upon completion of the clinical trial we will file and obtain 510(k) clearance to sell SERF ablation systems in the United States.