Electrode Array for Bloodless Liver Resection

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，即通过手术切除含有肿瘤的部分肝脏。该手术伴有大量失血量，通常在0.6 - 1l之间，失血量与患者的发病率和生存率呈负相关，特别是当需要输血时。我们发明了一种装置可以在3分钟内凝固一层肝组织，包括主要血管。该装置由电极线性阵列组成，射频（RF）能量在相邻电极之间以双极方式施加。通过我们的实验室原型，我们能够在猪肝脏中凝固组织切片，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。该装置有可能将肝切除手术中的出血量减少到最低限度，可能增加患者的存活率并降低并发症发生率。在这个提案中，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，在那里我们用我们的设备对五只动物进行肝脏切除。手术后将对这些动物进行四天的监测，并确定是否有术后内出血。

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.