Sealing Air Leaks by Inductive Coagulation Following Lung Surgery

描述（由申请人提供）：每年有近342，000名美国人死于肺病，特别是肺癌和慢性阻塞性肺病（COPD）。这使得肺病成为美国的第三大杀手，每七个死亡中就有一个是由肺病造成的。一般来说，对于肺癌或COPD，切除术提供了最好的生存机会和令人满意的生活质量。肺切除术后最常见的并发症是漏气，通常沿着缝钉线发生，发生率为34%-50%。市场上没有可靠的方法来防止这种泄漏，并且纠正处理可能复杂且昂贵。未来20年，仅COPD的经济成本就将达到约8000亿美元。密封和支撑肺组织中脆弱缝钉线的材料可以防止长时间漏气，从而消除长时间住院。此外，这种材料也可以证明适用于需要密封和加强的其他操作。在Rocky Mountain Biosystems，Inc.的（RMBI）初步研究中，对一种新型聚合物粘合剂密封剂和微创固化系统进行了广泛的体外测试，然后进行了体内测试，结果表明，该系统可完全消除漏气，并为肺组织中的缝钉线提供显著的附加强度。该新系统使用简单的聚合物粘合剂，该粘合剂使用射频感应耦合的非接触式过程在适当的位置固化。密封是紧密和防漏的，材料和装置是廉价的，并且生物相容性测试和体内组织的密封已经证明该制剂是安全和有效的。RMBI希望继续开发和测试这种新的手术系统，以推动其更接近临床试验，并最终，市场化。在第二阶段的研究中，RMBI建议：1。设计用于持续密封的缓慢溶解聚合物2。工程工艺和可再生聚合物生产3.在肺气肿动物肺模型中证明有效的密封。拟议研究的结果将验证一个独特的，具有成本效益的解决方案，以解决每年影响数十万患者的持续临床问题。公共卫生相关性：术后沿暴露缝钉线沿着漏气是所有肺部手术中最常见的并发症，发生在34% - 50%的患者中，并导致平均10 - 12天的住院时间延长。申请人开发的微创技术结合了一种快速固化的粘合剂，从而在支撑缝钉线和侧支组织时防止了长时间的漏气。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.