Sealing Air Leaks by Inductive Coagulation Following Lung Surgery

DESCRIPTION (provided by applicant): Approximately 400,000 lung surgeries are performed each year in the U.S. to treat chronic obstructive pulmonary disease and non-small cell lung cancer. Postoperative air leakage is the most common complication after lung surgery, occurring in as many of 50% of cases. A persistent air leak increases the incidence of morbidity and prolongs patient hospitalization, thereby incurring additional expenses. Reducing the hospital stay, by even one day, could save as much as one billion dollars annually in health care costs. The scientists at Rocky Mountain Biosystems have invented a method to anastomose and seal tissue that involves a biocompatible adhesive, consisting of protein and salt which is inductively activated by a 60 MHz radiofrequency magnetic field. Pilot testing of the device has proven feasibility for sealing dialysis needle perforations, femoral artery punctures, and anastomosing arteries. The non-contact process is safe, easy to use and inexpensive. The long-term objective of the proposed research is to develop a system suitable for sealing staple-lines in lung tissue for the purpose of eliminating air leaks after lung surgery. The three specific aims of the proposed research are: refine the adhesive formulation to make it more suitable for lung tissue; test the adhesive and system in vitro by proving that sealed lung tissue can withstand supraphysiologic pressures without failure; and prove feasibility in vivo by sealing a staple-line in rat lungs subsequently tested during normal ventilation. The long-term objective of this study is to provide enough information with which to design an animal study that proves the long-term effectiveness and safety of the procedure, thereby positioning the device for an FDA Investigational Device Exemption and human clinical trials. This process of inductively fusing and sealing tissue is unprecedented in the scientific literature. The technological innovation is immediately apparent, and the commercial applications of the method are manifold and address the broad field of wound repair. Thus, the commercial opportunities of the process are significant, and easily extend in the hundreds-of-millions of dollars per year. Relevance of research to public health: A safe, inexpensive and easy-to-use method to repair air leaks after lung surgery would result in reduced morbidity and mortality and consequently reduced health-care costs. Success of the research for which support is sought would prove feasibility and advance the technology to a point where an instrument could be commercially available within a few years.