Sealing Air Leaks by Inductive Coagulation Following Lung Surgery

肺部手术后通过感应凝固密封漏气

• 批准号: 7111219
• 负责人: Kevin Marchitto
• 金额: $ 13.17万
• 依托单位: ROCKY MOUNTAIN BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7111219
• 关键词: adhesions; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; heat; laboratory rat; lung disorder; magnetic field; nonhuman therapy evaluation; postoperative complications; radiowave radiation; respiratory disease /disorder therapy; surgical wound

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.

描述（由申请人提供）：美国每年进行大约400,000次肺手术，以治疗慢性阻塞性肺部疾病和非小细胞肺癌。术后泄漏是肺手术后最常见的并发症，发生在50％的病例中。持续的空气泄漏会增加发病率的发生率并延长患者住院，从而产生额外费用。减少医院的住宿甚至一天，每年可以节省多达十亿美元的医疗保健费用。落基山生物系统的科学家发明了一种吻合和密封组织的方法，该方法涉及生物相容性的粘合剂，由蛋白质和盐组成，该蛋白质和盐由60 MHz射频射频磁场受感应激活。该装置的试验测试已被证明可以可行，可密封透析针穿孔，股动脉穿刺和吻合动脉。非接触过程是安全，易于使用且价格便宜的。拟议研究的长期目标是开发一个适合于肺组织密封钉书钉线的系统，以消除肺部手术后的空气泄漏。拟议的研究的三个特定目的是：完善粘合剂配方，使其更适合肺组织；通过证明密封的肺组织可以承受超生理压力而不会失败来测试粘合剂和系统。并通过密封正常通气期间测试的大鼠肺中的主食来证明体内可行性。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，以证明该过程的长期有效性和安全性，从而为FDA研究设备豁免和人类临床试验提供了设备。在科学文献中，这种感应融合和密封组织的过程是前所未有的。该技术创新立即显而易见，该方法的商业应用是多种多样的，并解决了伤口修复的广泛领域。因此，该过程的商业机会很大，并且很容易每年延长数亿美元。研究与公共卫生的相关性：一种安全，廉价且易于使用的方法来修复肺部手术后的漏气性泄漏，从而导致发病率和死亡率降低，从而降低医疗保健费用。寻求支持的研究的成功将证明可行性并将技术推向了几年内可以在商业上获得工具的地步。