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4,000人死于这种疾病。本阶段I SBIR提案的目标是设计、开发、构建和测试一种新型冷却激光导管，以安全有效的方式实现支气管热成形术。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，以克服最严重患者的哮喘气道收缩。最近，基于射频（RF）的装置被引入市场，但是该装置具有缺点，包括破坏内皮，这可能导致短期内病情恶化。我们认为，通过采用BioTex开发的新型激光导管系统进行腔内表面下消融，可以获得显著的改善，这可能会导致更快的治疗给药，并应避免破坏内皮衬里和目前与基于RF的方法相关的“脱落”过程。 公共卫生相关性：SBIR项目的第一阶段目标是开发一种激光球囊导管，通过破坏导致哮喘“发作”的平滑肌组织来减少严重哮喘的症状。我们将开发原型导管，并在大型动物受试者中进行测试，以验证性能，为II期临床研究做准备。

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.