Sealing Air Leaks by Inductive Coagulation Following Lung Surgery

描述（由申请人提供）：美国每年约有40万例肺手术用于治疗慢性阻塞性肺疾病和非小细胞肺癌。术后漏气是肺部手术后最常见的并发症，发生率高达50%。持续的空气泄漏增加了发病率，延长了病人的住院时间，从而产生了额外的费用。即使减少一天的住院时间，每年也可以节省多达10亿美元的医疗费用。洛基山生物系统公司的科学家们发明了一种吻合和密封组织的方法，这种方法涉及一种由蛋白质和盐组成的生物相容性粘合剂，该粘合剂由60兆赫的射频磁场感应激活。该装置的中试试验已证明可用于封堵透析针穿孔、股动脉穿刺和吻合动脉。非接触式工艺安全、使用方便、价格低廉。该研究的长期目标是开发一种适合于在肺组织中密封钉线的系统，以消除肺手术后的空气泄漏。提出的研究的三个具体目标是：改进粘合剂配方，使其更适合肺组织；在体外测试粘合剂和系统，证明密封的肺组织可以承受超生理压力而不会失败；并通过在正常通气条件下对大鼠肺进行缝合来证明在体内的可行性。这项研究的长期目标是提供足够的信息来设计一项动物研究，以证明该程序的长期有效性和安全性，从而使该设备获得FDA研究性设备豁免和人体临床试验。这种诱导融合和密封组织的过程在科学文献中是前所未有的。技术创新是显而易见的，该方法的商业应用是多方面的，并解决了伤口修复的广阔领域。因此，这个过程的商业机会是巨大的，并且很容易扩大到每年数亿美元。研究与公共卫生的相关性：一种安全、廉价和易于使用的方法来修复肺部手术后的空气泄漏，将降低发病率和死亡率，从而降低保健费用。寻求支持的研究如果取得成功，将证明这项技术是可行的，并在几年内将这项技术推进到一种仪器可以商业化的程度。

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.