Sealing Lobectomy Air Leaks by Inductive Coagulation

DESCRIPTION (provided by applicant): Lung cancer is the leading cause of cancer mortality in both men and women in the United States and will cause an estimated 163,510 deaths in 2005, accounting for 29 percent of all cancer deaths. Surgical resections such assegmentectomy, lobectomies, or pnuemonectomies, provide the best chance of long-term disease-free survival. Postoperative air leakage at the raw parenchymal surfaces after surgery is the most frequent (34% to 50%) complication after lung surgery often resulting in an increased hospital stay. Reducing the hospital stay, by even one day, could save as much as one billion dollars yearly in health care costs. The investigators propose to prove the feasibility of sealing air leaks that arise on the raw lung surface exposed during a lobectomy by using a novel inductive coagulation device referred to as the Thermal HydroSeal (THS) system. The TSH system consists of a high-frequency magnetic field applicator, which inductively heats a biocompatible laminate adhesive thereby effecting cross-linking and a strong bond with the tissue. The Investigators have had excellent pilot results sealing lung and soft tissue wounds, in vitro and in vivo, with several TSH systems at 13.56, 27 and 60 MHz. The seals are tight and leak proof, materials and devices are inexpensive, and biocompatibility testing and sealing of tissues in vivo has proven the devices and adhesive formulations are safe. The results suggest an efficacious, unique and cost effective solution to a persistent clinical problem is at hand. In the proposed research, the Investigators will assemble and configure a THS device to be suitable for video-assisted thoracic surgery, at an extended frequency of 81 MHz, which theory suggests will be more efficient for curing adhesive. After development of a more flexible adhesive consisting of albumin, sodium chloride and a plastisizer, the system will be used to seal raw lung tissue, and the integrity of the seal will be tested in vitro by applying water pressure to the seal. Lastly, the THS system will be tested in vivo in an acute survival rabbit model which will involve performing a lobectomy, sealing the raw parenchyma, and testing the integrity of the seal during mechanical respiration. The long term objective of the research is to develop a clinical prototype THS system that is suitable for testing in human trials. The process of inductively fusing and sealing tissue is unprecedented in the scientific literature and the commercial possibilities of a safe, inexpensive and easy-to-use system to seal air leaks in lung tissue after surgery are significant. The commercial and improvement-in-patient-care potential of a safe, inexpensive and easy-to-use system to seal air leaks in lung tissue after surgery are significant as patient morbidity would be reduced and hospital stays would be shortened.