Sealing Lobectomy Air Leaks by Inductive Coagulation

描述（由申请人提供）：肺癌是美国男性和女性癌症死亡的主要原因，2005年估计将导致163，510人死亡，占所有癌症死亡的29%。外科切除术如肺段切除术、肺叶切除术或肺切除术为长期无病生存提供了最好的机会。手术后原始肺实质表面的术后漏气是肺手术后最常见的并发症（34%至50%），通常导致住院时间延长。减少住院时间，即使是一天，每年也可以节省多达10亿美元的医疗费用。研究者建议通过使用一种称为Thermal HydroSeal（THS）系统的新型感应凝固装置来证明在肺叶切除术期间暴露的原始肺表面上出现的密封漏气的可行性。TSH系统由高频磁场施加器组成，其感应加热生物相容性层压粘合剂，从而实现交联并与组织牢固粘合。研究者在体外和体内使用13.56、27和60 MHz的几种TSH系统凝闭肺和软组织伤口获得了良好的初步结果。密封紧密且防漏，材料和装置便宜，并且生物相容性测试和体内组织密封已证明装置和粘合剂制剂是安全的。结果表明，一个有效的，独特的和具有成本效益的解决方案，一个持续的临床问题是在手。在拟议的研究中，研究者将组装和配置THS器械，使其适用于视频辅助胸外科手术，扩展频率为81 MHz，理论表明这将更有效地固化粘合剂。在开发出由白蛋白、氯化钠和增塑剂组成的更灵活的粘合剂后，该系统将用于密封原始肺组织，并通过对密封施加水压在体外测试密封的完整性。最后，将在急性存活家兔模型中对THS系统进行体内试验，包括进行肺叶切除术、凝闭原始脑实质并在机械呼吸期间测试凝闭的完整性。该研究的长期目标是开发一种适用于人体试验的临床原型THS系统。感应融合和密封组织的过程在科学文献中是前所未有的，并且在手术后密封肺组织中的空气泄漏的安全、廉价且易于使用的系统的商业可能性是显著的。一种安全、廉价和易于使用的系统在外科手术后密封肺组织中的空气泄漏的商业和改善患者护理的潜力是显著的，因为患者发病率将降低，住院时间将缩短。

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.