Sealing Lobectomy Air Leaks by Inductive Coagulation

描述(申请人提供)：肺癌是美国男性和女性癌症死亡的主要原因，估计2005年将导致163,510人死亡，占所有癌症死亡人数的29%。手术切除，如节段切除、肺叶切除或肺切除，提供了长期无病生存的最好机会。术后创面漏气是肺部手术后最常见的并发症(34%至50%)，通常导致住院时间延长。即使减少住院一天，每年也可以节省多达10亿美元的医疗费用。研究人员建议证明，通过使用一种名为热液封(THS)系统的新型感应凝固设备，封堵肺叶切除术中暴露在原始肺面上的空气泄漏是可行的。TSH系统由高频磁场施加器组成，该高频磁场施加器感应加热生物相容的层压粘合剂，从而实现与组织的交联和牢固粘合。研究人员在体外和体内使用13.56、27和60 MHz的几种TSH系统封闭肺和软组织伤口，取得了良好的试点结果。密封严密，防泄漏，材料和设备廉价，体内组织的生物兼容性测试和密封已证明设备和粘合剂配方是安全的。结果表明，对于一个长期存在的临床问题，一种有效、独特和成本效益高的解决方案近在咫尺。在这项拟议的研究中，研究人员将组装和配置一种适用于电视辅助胸部手术的THS设备，扩展频率为81 MHz，理论上表明，这将更有效地固化粘合剂。在开发出一种由白蛋白、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，并将通过在密封上施加水压来测试密封的完整性。最后，THS系统将在急性存活的兔子模型中进行活体测试，包括进行肺叶切除，封闭原始实质，并在机械呼吸期间测试密封的完整性。这项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。诱导融合和封闭组织的过程在科学文献中是史无前例的，而安全、廉价和易于使用的系统在手术后封堵肺组织空气泄漏的商业可能性也是巨大的。一种安全、廉价和易于使用的系统来封堵手术后肺组织的空气泄漏，其商业和改善患者护理的潜力是重要的，因为患者的发病率将会降低，住院时间将会缩短。

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.