Development of Clinical Laser Septoplasty System

 描述(申请人提供)：在美国，大约每124人中就有1人，即220万人患有鼻中隔偏曲和相关的鼻塞。鼻中隔成形术是对有严重症状的患者保留的最后手段，因此患者只选择接受鼻中隔成形术作为整形鼻整形术的一部分。那些症状不那么严重的人将坚持长期的药物治疗，这最终会使当前的医疗体系不堪重负。据估计，每年至少有250,000例鼻中隔成形术，在美国最常见的外科手术中排名前十。最近，激光软骨重塑(LCR)已被临床证明是一种微创的替代手术。尽管LCR手术过程简单，但由于以下障碍，LCR尚未被临床医生广泛采用：(A)缺乏经济有效的激光系统用于软骨重塑；(B)由于缺乏适当的冷却方法而导致与热有关的组织损伤。我们的最终目标是以经济高效的方式为常规鼻中隔成形术提供安全和用户友好的激光治疗系统，以解决这些障碍。在这个第一阶段的SBIR方案中，我们将建造和测试一个可用于临床的新型激光系统原型和一个具有组织冷却功能的探头，用于鼻中隔成形术软骨重塑。在成功完成后，该装置将用于在未来的第二阶段提案中进行第一次试点人体试验。

 DESCRIPTION (provided by applicant): Approximately, 1 in 124 people, or 2.2 million people in USA suffer from deviated septum and related nasal obstruction. Nasal septoplasty, a surgical approach is reserved as the last resort for patients with severe symptoms so patients only opt to receive septoplasty as part of a cosmetic rhinoplasty. Those with less severe symptoms would stick with long-term pharmacologic treatments, which ultimately overburden the current health care system. It is estimated that at least 250,000 septoplasties are performed annually, ranking in the top ten of the most common surgical procedures performed in the U.S. Recently, laser cartilage reshaping (LCR) has been demonstrated clinically as a minimally invasive alternative procedure. Despite the simplicity of the procedure, LCR has not been widely adopted by the clinicians due to the following barriers: (a) lack of availability of cost-effective laser system fr cartilage reshaping, and (b) heat related tissue damage from lack of proper cooling method. Our ultimate goal is to address these barriers by delivering a safe and user-friendly laser therapy system for routine septoplasty in cost-effective manner. In this Phase 1 SBIR proposal, we will build and test a clinic-ready prototype new laser system and a probe with tissue cooling feature for septoplasty cartilage re-shaping. Upon successful completion, the device will be used to carry out a first pilot human trial in future Phase 2 proposals.