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: 7802286
• 负责人: Kevin Marchitto
• 金额: $ 82.67万
• 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 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7802286
• 关键词: Adherence; Adhesions; Adhesives; Affect; Air; American; Americas; Animal Model; Animals; Attention; Biodegradation; Breathing; Cessation of life; Chronic Obstructive Airway Disease; Clinical; Clinical Trials; Coagulation Process; Complication; Coupling; Data; Development; Devices; Doctor of Medicine; Drug Formulations; Elasticity; Engineering; Ensure; Excision; Exhalation; Extravasation; Health Care Costs; Healthcare Systems; Human; In Situ; In Vitro; Incidence; Left; Length of Stay; Life; Longevity; Lung; Lung Volume Reductions; Lung diseases; Malignant neoplasm of lung; Manufacturer Name; Methodology; Methods; Modeling; Modification; Operative Surgical Procedures; Patients; Pennsylvania; Performance; Phase; Polymers; Postoperative Period; Process; Production; Property; Protocols documentation; Quality of life; Recovery; Research; Respiratory physiology; Solutions; Structure of parenchyma of lung; System; Techniques; Tensile Strength; Testing; Thoracic Surgeon; Tissue Adhesives; Tissues; University Hospitals; Validation; adhesive polymer; biomaterial compatibility; clinically relevant; commercialization; cost; crosslink; density; economic cost; improved; in vitro testing; in vivo; manufacturing process; meetings; minimally invasive; novel; operation; prevent; product development; prototype; public health relevance; radiofrequency; response; scale up; seal; tool; treatment site; wound

DESCRIPTION (provided by applicant): Close to 342,000 Americans die of lung disease each year, particularly from lung cancer and chronic obstructive pulmonary disease (COPD). This makes lung disease America's number three killer, responsible for one in every seven deaths. In general, for lung cancer or COPD, resection presents the best chance of survival and an agreeable quality of life. The most frequent complication following lung resection is air leakage, which typically occurs along the staple line and has an incidence from 34% to 50%. There is no reliable method in the marketplace to prevent this leakage, and the corrective treatment can be complicated and expensive. The economic cost of COPD alone will amount to about $800 billion over the next 20 years. A material that seals and bolsters the delicate staple line in lung tissue could preclude prolonged air leakage and thus eliminate extensive hospital stays. Additionally, such a material could also prove suitable for other operations where sealing and strengthening is desirable. In Rocky Mountain Biosystems, Inc.'s (RMBI) preliminary studies, a novel polymeric adhesive sealant and minimally-invasive curing system was tested extensively in vitro, then in vivo, and was shown to completely eliminate air leaks and provide substantial added strength to the staple line in lung tissue. The novel system uses a simple polymeric adhesive that is cured in place using a non-contact process of radiofrequency inductive coupling. The seals are tight and leak proof, materials and devices are inexpensive, and biocompatibility testing and sealing of tissues in vivo has proven the formulations are safe and efficacious. RMBI desires to continue the development and testing of this new surgical system in order to advance it closer to clinical trials and ultimately, marketability. In Phase II research, RMBI proposes to: 1. Engineer Slow Dissolution Polymer for Sustained Seal 2. Engineer Processes and Validate Polymer Production 3. Demonstrate Efficacious Seal in Emphysemic Animal Lung Model. The results of the proposed research will validate a unique, cost-effective solution to a persistent clinical problem that affects hundreds of thousands of patients every year. PUBLIC HEALTH RELEVANCE: Postoperative air leakage along the exposed staple line is the most frequent complication in all lung surgeries, occurring in 34% - 50% of patients, and resulting in prolonged hospital stays of 10 to12 days on average. The minimally invasive technique developed by the applicant incorporates an adhesive that quickly cures, thus precluding prolonged air leakage while buttressing the staple line and collateral tissue.

描述（由申请人提供）：每年近342,000名美国人死于肺部疾病，尤其是肺癌和慢性阻塞性肺疾病（COPD）。这使肺部疾病是美国第三杀手，每七人死亡。通常，对于肺癌或COPD，切除是生存的最佳机会和令人愉快的生活质量。肺切除后最常见的并发症是空气泄漏，通常沿着主食线发生，发病率从34％至50％。市场上没有可靠的方法来防止这种泄漏，纠正措施可能是复杂且昂贵的。在未来20年中，仅COPD的经济成本将达到约8000亿美元。一种密封和巩固肺组织中细腻的主食线的材料可能会排除长时间泄漏的延长，从而消除了广泛的住院。此外，这种材料还可以证明适用于需要密封和加强的其他操作。在洛矶山脉生物系统，Inc。（RMBI）的初步研究中，对新型的聚合物粘合剂密封剂和微创固化系统进行了广泛的测试，然后在体内进行了广泛的测试，并显示出可完全消除空气泄漏并为肺组织中的钉钉线提供实质性强度。新型系统使用一种简单的聚合物粘合剂，该粘合剂使用非接触射频电感偶联过程将其固化。密封件紧密且泄漏，材料和设备价格便宜，体内组织的生物相容性测试和密封已经证明了配方是安全有效的。 RMBI希望继续开发和测试这种新的手术系统，以使其更接近临床试验，并最终可销售。在第二阶段研究中，RMBI提出：1。持续密封的工程师慢溶解聚合物2。工程师工艺和验证聚合物生产3。拟议的研究结果将证明一种独特的，具有成本效益的解决方案，以解决每年影响数十万患者的持续临床问题。公共卫生相关性：沿裸露的主食线沿术后空气泄漏是所有肺手术中最常见的并发症，发生在34％ - 50％的患者中，导致平均住院时间为10至12天。申请人开发的最小侵入性技术结合了一种迅速固化的粘合剂，从而排除了长时间的空气泄漏，同时支撑了主食线和侧支组织。