Development of Clinical Laser Septoplasty System

临床激光鼻中隔成形术系统的研制

• 批准号: 8981219
• 负责人: Dmitry Protsenko
• 金额: $ 19.36万
• 依托单位: INCIPIAN, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8981219
• 关键词: Address; Adopted; Adoption; Area; Cartilage; Cells; Chills; Clinic; Clinical; Conventional Surgery; Cosmetics; Data; Development; Devices; Engineering; Equilibrium; Evaluation; Foundations; Future; Goals; Healthcare Systems; Heating; Human; Laser Scanning Confocal Microscopy; Lasers; Light; Low-Level Laser Therapy; Measures; Mechanics; Medical; Methods; Mucous Membrane; Nasal obstruction present finding; Nasal septum structure; Nose; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Patient Care; Patients; Performance; Phase; Pilot Projects; Procedures; Relaxation; Resort; Safety; Sapphire; Shapes; Small Business Innovation Research Grant; Specific qualifier value; Structure; Structure of mucous membrane of nose; Surface; Swelling; Symptoms; System; Techniques; Temperature; Testing; Therapeutic; Thick; Time; Tissues; Validation; base; cost; cost effective; design; dosage; irradiation; minimally invasive; novel; phase 2 study; prevent; prototype; public health relevance; rhinoplasty; user-friendly

 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.

 描述（由申请人提供）：在美国，大约每 124 人（即 220 万人）中就有 1 人患有鼻中隔偏曲和相关鼻中隔成形术，手术方法是症状严重的患者的最后手段，因此患者只选择手术。接受鼻中隔成形术作为美容鼻整形术的一部分，那些症状不太严重的人会坚持长期药物治疗，这最终会给当前的医疗保健系统带来负担。据估计，每年至少进行 250,000 例鼻中隔成形术，位居美国最常见外科手术前十名。最近，激光软骨整形 (LCR) 已被临床证明是一种微创替代手术，尽管其操作简单。在该手术中，由于以下障碍，LCR 尚未被信徒广泛采用：(a) 缺乏具有成本效益的软骨重塑激光系统，以及 (b) 与热相关的组织损伤由于缺乏适当的冷却方法，我们的最终目标是通过以具有成本效益的方式为常规鼻中隔成形术提供安全且用户友好的激光治疗系统来解决这些障碍。准备好的新激光系统原型和具有组织冷却功能的探针，用于鼻中隔成形术软骨重塑。成功完成后，该设备将用于在未来的第二阶段提案中进行首次人体试验。