Preventing Pneumothorax During Transthoracic Lung Biopsy

经胸肺活检期间预防气胸

• 批准号: 9909407
• 负责人: Stephen Harry Spiegelberg
• 金额: $ 14.71万
• 依托单位: CAMBRIDGE POLYMER GROUP, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-18 至 2021-01-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909407
• 关键词: Adhesions; Aging; Air; Area; Biocompatible Materials; Biological Assay; Biomechanics; Biopsy; Blood; Cells; Chemicals; Chest Tubes; Chest wall structure; Chitosan; Client satisfaction; Complication; Custom; Cytostatics; Development; Devices; Diagnostic Procedure; Diagnostic radiologic examination; Ensure; Environment; FDA approved; Family suidae; Fibroblasts; Formulation; Gel; Goals; Hospitalization; Hour; In Vitro; Injectable; Injections; Investigation; Lung; Malignant neoplasm of lung; Medical; Medical Care Costs; Medical Device; Methods; Modeling; Monitor; Mus; Needle biopsy procedure; Needles; Operative Surgical Procedures; Outcome; Pathway interactions; Patient-Focused Outcomes; Patients; Phase; Pneumothorax; Polymers; Preparation; Procedures; Property; Puncture procedure; Research; Resistance; Respiratory distress; Risk Assessment; Safety; Saline; Site; Small Business Innovation Research Grant; Sterilization; System; Testing; Time; Tissues; Toxic effect; Toxicology; Trocars; Validation; Variant; animal safety; base; biomaterial compatibility; cancer diagnosis; chemical synthesis; comparative; cost; cytotoxicity; genipin; improved; in vivo; novel; pressure; prevent; radiologist; safety study; seal; standard of care; success

Project Summary Annually, over 1.2 million CT-guided lung biopsies are performed worldwide for lung cancer diagnosis (~400,000 in the US). Pneumothorax (PTX) — a collapsed lung, is the most common complication of this procedure, occurring in 20-40% of all CT-guided lung biopsies. In 10-15% of lung biopsies, the patient becomes symptomatic due to PTX and requires an invasive chest tube insertion, the definitive treatment for PTX. This complication costs, on an average, $15k per chest tube insertion and $1.3 billion worldwide to treat. This turns a same-day diagnostic procedure into a multi-day hospitalization. In addition to extreme respiratory distress to patients, it is inconvenient for radiologists to manage. PTX arises when air from the lungs or external environment enters the area between the chest wall and lungs during or after needle insertion due to a pressure difference. A recent time dependent analysis of 3,251 patients undergoing CT-guided lung biopsy demonstrated that ~75% of PTX occur while the needle is inserted (meaning air is actively leaking during the procedure). Several methods are used for preventing PTX due to biopsy, including only FDA approved device, blood/saline patch and air aspiration. All of these methods, however, are for application to the puncture site once the biopsy is complete and therefore relatively ineffective (<50%). Additionally, they add time (>10mins) and steps (>5) to the procedure. The development of a novel biopsy needle tract biosealant that will reduce or eliminate pneumothorax would be most valuable. The focus of the current investigation is to evaluate and demonstrate the possibility of using a biosealant and delivery device to seal needle tracts to prevent PTX during transthoracic lung biopsy. Further, win-vitro and in-vivo preliminary biocompatibility of the material as well as efficacy of the delivery device as compared to the current standard of care.

项目摘要 每年，全世界为肺癌进行超过120万个CT引导的肺活检 诊断（美国约40万）。气胸（PTX） - 塌陷的肺，是最常见的 该过程的并发症发生，发生在所有CT引导的肺活检中的20-40％中。 10-15％ 肺活检，患者由于PTX而变得有症状，需要侵入性胸部 管插入，PTX的确定治疗方法。这种并发症的成本平均为$ 15K 每胸管插入和全球13亿美元的治疗。这变成了同一天的诊断 将多天住院的程序进行操作。除了对患者的极端呼吸窘迫之外， 放射性人士要管理是不方便的。 当肺部或外部环境进入胸部之间的区域时，PTX出现 由于压力差而导致针头插入期间或之后的壁和肺。最近的时间 对3,251例接受CT引导肺活检的患者的依赖分析表明， 在插入针头时发生了〜75％的PTX（这意味着空气正在积极泄漏 程序）。几种方法用于防止活检，包括FDA 批准的装置，血/盐水斑块和空气吸入。但是，所有这些方法都是为了 一旦活检完全，相对无效 （<50％）。此外，它们将时间（> 10分钟）和步骤（> 5）添加到该过程中。 一种新型活检针形的生物乳白色的开发，将减少或消除 气胸最有价值。当前调查的重点是评估和 证明使用生物颜料和递送装置将针刺密封到 在经胸腔活检期间预防PTX。此外，win-vitro和体内初步 与材料的生物相容性以及交付设备的易于 当前的护理标准。