Close to 342,000 Americans die of lung disease each year, particularly from lung cancer and chronic obstructive pulmonary disease (COPD). This makes lung disease America's number three killer, responsible for one in every seven deaths. In general, for lung cancer or COPD, resection presents the best chance of survival and an agreeable quality of life. The most frequent complication following lung resection is air leakage, which typically occurs along the staple line and has an incidence from 34% to 50%. There is no reliable method in the marketplace to prevent this leakage, and the corrective treatment can be complicated and expensive. The economic cost of COPD alone will amount to about $800 billion over the next 20 years. A material that seals and bolsters the delicate staple line in lung tissue could preclude prolonged air leakage and thus eliminate extensive hospital stays. Additionally, such a material could also prove suitable for other operations where sealing and strengthening is desirable. In Rocky Mountain Biosystems, Inc.'s (RMBI) preliminary studies, a novel polymeric adhesive sealant and minimally-invasive curing system was tested extensively in vitro, then in vivo, and was shown to completely eliminate air leaks and provide substantial added strength to the staple line in lung tissue. The novel system uses a simple polymeric adhesive that is cured in place using a non-contact process of radiofrequency inductive coupling. The seals are tight and leak proof, materials and devices are inexpensive, and biocompatibility testing and sealing of tissues in vivo has proven the formulations are safe and efficacious. RMBI desires to continue the development and testing of this new surgical system in order to advance it closer to clinical trials and ultimately, marketability. In Phase II research, RMBI proposes to: 1. Engineer Slow Dissolution Polymer for Sustained Seal 2. Engineer Processes and Validate Polymer Production 3. Demonstrate Efficacious Seal in Emphysemic Animal Lung Model. The results of the proposed research will validate a unique, cost-effective solution to a persistent clinical problem that affects hundreds of thousands of patients every year.
Postoperative air leakage along the exposed staple line is the most frequent complication in all lung surgeries, occurring in 34% - 50% of patients, and resulting in prolonged hospital stays of 10 to12 days on average. The minimally invasive technique developed by the applicant incorporates an adhesive that quickly cures, thus precluding prolonged air leakage while buttressing the staple line and collateral tissue.
