MEDICAL ENGINEERING INNOVATIONS, LLC — Department of Health and Human Services SBIR Phase II: 102

Description

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 L Blood loss is adversely associated with patient morbidity and survival particularly when blood transfusions are required We have developed a liver resection device that allows coagulation of a plane of liver tissue within min 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 This liver resection 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 If resection is not possible tumors are often directly treated by heat based thermal ablation Based on the same blade electrode platform we have in addition developed a prototype circumferential electrode array that allows rapid direct treatment of large tumors with sufficient advantages in terms of efficacy compared to current available devices Both types of the electrode arrays are driven by a multi channel radiofrequency generator RFG The output of this RFG is modulated based on measurements of the tissue impedance which allows us to account for differences in tissue thickness and determine when the tissue has been sufficiently coagulated ablated In this project we will produce a clinical prototype RFG and circumferential electrode array suitable for human use and perform preclinical animal studies Based on early prototype studies it is expected that these new devices will lower health care costs and reduce morbidity and mortality PUBLIC HEALTH RELEVANCE We will develop a system for assisting liver cancer treatment during surgery and for use during localized thermal therapy Our device will if successful reduce blood loss during liver surgery to a minimum and allow rapid treatment of large tumors This will likely result in reduced complications due to bleeding during surgery and increase patient survival rates It will lower health care costs and reduce morbidity and mortality