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(申请人提供)：美国每年约有400,000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，发生在多达50%的病例中。持续的空气泄漏增加了发病率，延长了患者的住院时间，从而产生了额外的费用。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。落基山生物系统的科学家们发明了一种吻合和密封组织的方法，这种方法涉及一种生物相容性粘合剂，这种粘合剂由蛋白质和盐组成，由60 MHz射频磁场感应激活。该设备的中试已经证明了封闭透析针穿孔、股动脉穿孔和吻合动脉的可行性。这种非接触式工艺安全、使用方便、价格低廉。这项拟议研究的长期目标是开发一种适合于封闭肺组织中的吻合线的系统，以消除肺手术后的空气泄漏。拟议研究的三个具体目标是：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可以承受肺表面的压力而无故障地在体外测试粘合剂和系统；通过密封大鼠肺部的吻合线在体内证明其可行性，随后在正常通风条件下进行测试。这项研究的长期目标是提供足够的信息，以设计一项动物试验，证明该程序的长期有效性和安全性，从而为FDA调查装置豁免和人类临床试验定位该装置。这种诱导融合和封闭组织的过程在科学文献中是前所未有的。技术创新立竿见影，这种方法的商业应用是多方面的，并解决了伤口修复的广阔领域。因此，这一过程的商业机会是巨大的，而且很容易扩展到每年数亿美元。研究与公共健康的相关性：一种安全、廉价和易于使用的方法来修复肺部手术后的空气泄漏将减少发病率和死亡率，从而降低医疗保健成本。如果寻求支持的研究取得成功，将证明其可行性，并将该技术推进到几年内可将仪器投入商业使用的程度。