Sealing Lobectomy Air Leaks by Inductive Coagulation

通过感应凝固密封肺叶切除术漏气

基本信息

批准号：
7157132
负责人：
Kevin Marchitto
金额：
$ 14.32万
依托单位：
ROCKY MOUNTAIN BIOSYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-08-01 至 2007-10-31
项目状态：
已结题

项目摘要

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.

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，预计 2005 年将导致 163,510 人死亡，占所有癌症死亡的 29%。手术切除，如肺段切除术、肺叶切除术或肺切除术，提供了长期无病生存的最佳机会。手术后原始实质表面的术后漏气是肺部手术后最常见的（34% 至 50%）并发症，通常会导致住院时间增加。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。研究人员提议使用一种称为热水密封（THS）系统的新型感应凝固装置来证明密封肺叶切除术期间暴露的原始肺表面上出现的漏气的可行性。 TSH 系统由高频磁场施加器组成，该施加器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。研究人员使用 13.56、27 和 60 MHz 的多个 TSH 系统在体外和体内密封肺和软组织伤口方面取得了出色的试点结果。密封严密且防漏，材料和设备价格便宜，生物相容性测试和体内组织密封已证明设备和粘合剂配方是安全的。结果表明，针对持续存在的临床问题的有效、独特且具有成本效益的解决方案即将到来。在拟议的研究中，研究人员将组装和配置适合视频辅助胸外科手术的 THS 设备，扩展频率为 81 MHz，理论上该设备对于固化粘合剂会更有效。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，并通过向密封件施加水压来在体外测试密封件的完整性。最后，THS 系统将在急性存活兔模型中进行体内测试，其中包括进行肺叶切除术、密封原始实质，并在机械呼吸过程中测试密封的完整性。该研究的长期目标是开发适合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，并且安全、廉价且易于使用的系统在手术后密封肺组织中的漏气的商业可能性是巨大的。手术后密封肺组织漏气的安全、廉价且易于使用的系统具有巨大的商业潜力和改善患者护理的潜力，因为这将降低患者的发病率并缩短住院时间。