Laser Catheter for Bronchial Treatment of Severe Asthma

描述（由申请人提供）：哮喘折磨着多达3900万美国人，每年约有4000人将死于该病。这项I期SBIR提案的目标是设计、开发、构建和测试一种新型的冷却激光导管，以安全有效的方式影响支气管热成形术。支气管热成形术是一个相对较新的术语，指的是破坏细支气管（肺中的管状气道分支）周围的肌肉粘膜，以努力消除最严重的哮喘患者的气道收缩。最近，一种基于射频（RF）的设备被引入市场，但该设备的缺点是破坏内皮细胞，可能导致短期内病情恶化。我们相信，采用BioTex公司开发的新型激光导管系统进行腔内表面下消融可能会取得显著的改善，这可能会导致更快的治疗给药，并且应该避免内皮层的破坏和目前基于射频的方法所导致的“脱落”过程。

DESCRIPTION (provided by applicant): Asthma afflicts as many as 39 million Americans and some 4,000 will die of the disease each this year. The goal of this Phase I SBIR proposal is to design, develop, build, and test a novel, cooled laser catheter for effecting Bronchial Thermoplasty in a safe and efficient manner. Bronchial Thermoplasty is a relatively new term which refers to destruction of the muscular mucosa surrounding the bronchioles (tubular airway branches in the lungs) in an effort to defeat asthmatic airway constriction for the most severely afflicted patients. Recently, a radio-frequency (RF)-based device was introduced onto the market, but the device has drawbacks including the destruction of the endothelium which can result in worsening of condition in the short term. We believe that significant improvement may be obtained by employing a novel laser-based catheter system developed by BioTex for intraluminal sub-surface ablation which may result in faster therapeutic administration and should avoid destruction of the endothelial lining and the resulting "sloughing" process currently associated with RF- based methods. PUBLIC HEALTH RELEVANCE: The goal of this Phase I SBIR project is to develop a laser balloon catheter for reduction of symptoms in severe asthma by destroying the smooth muscle tissue which leads to asthma "attacks". We will develop prototype catheters and test them in large animal subjects to verify performance in preparation for clinical studies in Phase II.