Electrode Array for Bloodless Liver Resection

描述(申请人提供)：原发性和转移性肝癌在美国和全世界都很常见。肝癌的标准治疗方法是肝切除术，即通过外科手术切除含有肿瘤的部分肝脏。这种手术与大量失血有关，通常在0.6-1升之间。失血与患者的发病率和存活率呈负相关，特别是在需要输血的情况下。我们已经开发了一种设备，可以在3分钟内凝固一平面的肝组织，包括主要血管。该装置由线性电极阵列组成，在相邻电极之间以双极方式向其施加射频(RF)能量。有了我们的实验室原型，我们能够在活体内凝固猪肝脏的组织切片，包括所有血管(直径达4.3毫米)，然后沿着凝固的切片切除，出血可以忽略不计。这种装置有可能将肝脏切除手术中的失血量减少到最低限度，并有可能增加患者的存活率，降低并发症发生率。在这项提案中，我们计划使用我们目前的实验室原型来研究三种不同的电极尺寸。我们将根据所需的性能确定理想的电极配置，同时限制由于电极插入造成的组织损伤。然后，我们将在动物生存研究中展示我们的原型的可行性，在该研究中，我们用我们的设备在五只动物身上进行肝脏切除。这些动物将在手术后接受为期四天的监测，并将确定手术后是否有内出血。

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. This operation is associated with considerable blood loss, typically between 0.6 - 1 L. Blood loss is adversely associated with patient morbidity and survival, particularly when blood transfusions are required. We have developed a device that allows coagulation of a plane of liver tissue within 3 minutes, including major vessels. The device consists of a linear array of electrodes, to which radiofrequency (RF) energy is applied in bipolar fashion between neighboring electrodes. With our laboratory prototype we were able to coagulate a tissue slice in vivo in porcine liver, including all vessels (up to 4.3 mm in diameter), and subsequently resect along the coagulated slice with negligible bleeding. This device has the potential of reducing blood loss during liver resection surgery to a minimum, with likely increase in patient survival and lowered complication rates. In this proposal we plan use our current laboratory prototype to investigate three different electrode sizes. We will determine the ideal electrode configuration in terms of required performance while limiting tissue trauma due to electrode insertion. We will then show feasibility of our prototype in an animal survival study, where we perform liver resection with our device in five animals. The animals will be monitored for four days after surgery, and any post-operative internal bleeding will be determined.