Radiofrequency ablation (RFA) is widely and increasingly utilized in cases where surgery is not possible as a minimally invasive treatment for cancer. Despite rapid adoption of this technique due to its proven success in treating smaller tumors, however, clinicians have been unable to consistently achieve the desired goal of complete and/or predictable ablation for many larger tumors. Manufacturers of RFA systems have tried to address this limitation, inter alia, by developing RF generators with ever increasing power. However, as the power of RF ablation systems has increased over the years, the incidence of skin burns at the grounding pad sites has increased as well. The current incidence of grounding-pad skin burns ranges from 1-3.2 % for severe skin burns (2nd or 3rd degree), with mild skin burns ranging between 5-33 %. The statistics on file with the legal department at 3M Healthcare indicate that the mean expected (or anticipated) rate of severe burns associated with the use of all types of grounding pads is 1% and that this translates to ~5000 instances per year in the United States. It is estimated that 10% of the patients that suffer from serious burns every year are contacted by medical malpractice attorneys and encouraged to begin the process of litigation. As a result, records indicate that approximately 200 Million (MM)$ have been unnecessarily drained from the critical healthcare sector and forcibly transferred to the more wasteful litigation sector over the last 10 years. Given the ever-increasing rate of RFA adoption as well as RFA power-usage, it is projected that this loss will double to 400 MM$ over the next decade. The solution, then, lies in the innovative development of a vastly more efficient type of grounding pad that can safely &efficiently reduce the potential for skin-burns in a manner that is simple enough such that it does not require expensive changes to the capital equipment that is currently in use. We have developed prototypes of such a hyper-efficient yet inexpensive "smart" grounding pad. The smart-pad is a simple combination of a conventional grounding pad and a special layer of a novel Polymeric Electro-Thermal Switch (PETS) material. The PETS layer in the smart-pad automatically regulates current densities such that the temperature at the skin can never exceed a pre-set threshold, thereby significantly reducing the probability of acute as well as latent skin-burns. It also vastly increases the area-usage efficiency of the pad by automatically diverting the incoming current away from the hotter regions and towards the regions that tend to stay cooler by virtue of its intrinsic properties. In this Phase-I SBIR/STTR project, we will demonstrate proof of application of this novel smart-pad by focusing on two core issues: (a) In vivo validation of the smart-pad performance in a porcine model, and, (b) Development of smart-pads with varying threshold-temperatures so as to determine the actual &optimum safety factor in in vivo use. The former confirms that the technology correctly translates from the simple bench model to the more complex and more realistic animal model. The latter ensures that the technology has an optimum safety-factor that is still large to allow safe function in a reliable manner when in widespread use. In the long run, the success of this project will reduce the potential for skin- burns, thereby containing the runaway skin-burn related litigation costs that currently burden the healthcare system.
The overall goal of this SBIR project is to develop a novel "smart" grounding pad in order to lower the potential for skin- burns that is associated with the ever- increasing wattage being used in the RFA of cancer. The proposed smart grounding pad will lower the wasteful leakage of funds from the healthcare sector by reducing the potential for the type of burn- related litigation that currently bleeds the industry. This implies that the smar pad could increase patient safety while simultaneously lowering healthcare costs in the RFA of cancer.