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）：美国每年约有40万例肺部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和患者住院率，从而导致额外的费用。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。Rocky Mountain Biosystems的科学家们发明了一种方法来固定和密封组织，该方法涉及生物相容性粘合剂，由蛋白质和盐组成，由60 MHz射频磁场感应激活。该器械的初步试验已证明了密封透析针穿孔、股动脉穿刺和闭塞动脉的可行性。非接触式过程是安全的，易于使用和廉价的。拟议研究的长期目标是开发一种适用于密封肺组织中的缝钉线的系统，以消除肺部手术后的漏气。拟定研究的三个具体目的是：改进粘合剂配方，使其更适合肺组织;通过证明密封的肺组织能够承受超生理压力而不会失效，在体外测试粘合剂和系统;通过密封大鼠肺中的缝钉线，随后在正常通气期间进行测试，证明体内可行性。本研究的长期目标是提供足够的信息，用于设计动物研究，证明手术的长期有效性和安全性，从而将器械定位为FDA研究器械豁免和人体临床试验。这种感应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泛领域。因此，该方法的商业机会是显著的，并且容易地以每年数百万美元的规模扩展。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漏气，将降低发病率和死亡率，从而降低医疗保健费用。寻求支持的研究如果成功，将证明其可行性，并将技术推向一个新的水平，使仪器在几年内就可投入商业使用。