Articulating Video Stylet for Improved Intubation Success Rates

铰接视频管芯以提高插管成功率

• 批准号: 10009450
• 负责人: Laura L McCormick
• 金额: $ 64.55万
• 依托单位: BRIO DEVICE, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009450
• 关键词: Address; Adult; Adverse event; Anatomy; Anesthesia procedures; Anesthesiology; Anterior; Articulation; Brain; Bronchoscopes; Caliber; Caregivers; Caring; Child; Childhood; Clinical; Community Hospitals; Critical Care; Development; Devices; Disease; Economics; Emergency Medicine; Endoscopes; Feedback; First Aid; Goals; Grant; Hospitals; Hour; Hypoxia; Incidence; Intratracheal Intubation; Intubation; Intuition; Knowledge; Laryngoscopy; Larynx; Learning; Life; Manikins; Mechanics; Medical Device; Minor; Modification; Morbidity - disease rate; Movement; Neonatal; Neonatology; Newborn Infant; Optics; Outcome; Pediatrics; Phase; Population; Positioning Attribute; Price; Procedures; Property; Registries; Research; Sales; Savings; Small Business Innovation Research Grant; Syndrome; Technology; Testing; Time; Training; Translations; Tube; Visual; Visualization; base; commercial application; cost; design; endotracheal; flexibility; health care delivery; high risk; improved; mechanical properties; neonate; patient safety; pediatric patients; phase 1 study; portability; prevent; prototype; respiratory; simulation; success; tool; usability

Project Summary More than 20 million intubations are performed in the US every year and may carry a high rate of procedure-related and disease-related complications. The higher incidence of difficult intubation in children is due to a more anterior larynx and presence of congenital syndromes resulting in 20% suffering complications during and related to airway management. Difficult intubations in pediatric patients are most common in the smallest children and in those who have multiple attempts at direct laryngoscopy. Brio Device, LLC, an airway management medical device company, has spent hundreds of hours of primary and secondary research to determine the gap in current technology limiting intubation success rates. From this research, Brio has addressed user needs in developing an articulating video stylet (AVS) for the Phase I grant. The ability of the AVS to reduce learning curve and enable novice users to successfully intubate quickly and on the first attempt has driven the company to pursue a neonate size AVS (nAVS) which addresses a market high in need but with a dearth of visual intubation tools. There are three critical components of the nAVS, specifically the position of the camera on the stylet which provides a view of the functional tip in relation to the anatomy, the semi-rigid stylet and articulation capability which provide one-to-one translation of ex-vivo movements in the airway space, thus making it easy to maser, and finally the sub-3mm diameter which makes it usable for neonatal and larger pediatric patients. The goal for Phase II is to create a sub-3mm stylet with the same visualization as the adult AVS and same mechanical properties which have been proven to enable successful first-pass intubation with Brio's INT Navigator™ articulating stylet and the AVS. To achieve this goal, iterations of the mechanical aspects of the stylet will be designed and bench-tested until achieving similar rigidity and articulation as the adult AVS. Optics will also be designed to suit this very small stylet yet still able to maintain the unique position responsible for reducing the learning curve. Finally, the efficacy will be validated through a comparison study with the Glidescope AVL preterm/small child intubating device. In 2016, the orotracheal intubation market in the US was ~$435 million and is estimated to reach $619.8 million by 2023, at a CAGR of 5.1% during the forecast period. Of the 3,304,364 newborns born in 2012 in the US, 7.2% (or 237,914 babies) were admitted to the NICU in that year and 25% required intubation for respiratory support (~60,000 neonate intubations). With limited competition serving this pediatric market, Brio forecasts selling 2,000 disposable nAVS units at a price-point of $300/unit for a total of $600,000 in revenue in the first year of sales. When combined with Brio's INT NavigatorTM and related intubation products, gross profits of $30+ million are forecasted after five years in the market.

项目概要 美国每年进行超过 2000 万次插管，并且插管率可能很高 手术相关和疾病相关的并发症。儿童插管困难发生率较高 由于喉部更靠前并且存在先天性综合征，导致 20% 的人出现并发症 气道管理期间以及与之相关。儿科患者插管困难最常见于 最小的儿童以及多次尝试直接喉镜检查的儿童。 Brio Device, LLC，气道 管理医疗器械公司，花费了数百小时的初级和二级研究 确定当前技术的差距限制插管成功率。根据这项研究，布里奥 满足了用户在为第一阶段拨款开发铰接视频管芯 (AVS) 时的需求。的能力 AVS 可缩短学习曲线，使新手用户能够在第一次尝试时快速成功插管 促使该公司追求新生儿尺寸 AVS (nAVS)，该产品满足了高需求市场的需求，但 缺乏可视插管工具。 nAVS 包含三个关键组件，特别是摄像头在探针上的位置 提供与解剖结构、半刚性管心针和关节功能相关的功能尖端视图 它提供气道空间中离体运动的一对一翻译，从而使其易于掌握， 最后是小于 3 毫米的直径，使其可用于新生儿和较大的儿科患者。 第二阶段的目标是创建一个低于 3mm 的管心针，其可视化效果与成人 AVS 相同，并且与成人 AVS 相同。 机械特性已被证明能够通过 Brio 的 INT 成功进行首次插管 Navigator™ 关节管芯和 AVS。为了实现这一目标，机械方面的迭代 将设计管心针并进行台架测试，直到达到与成人 AVS 相似的刚性和关节。光学 也将被设计成适合这种非常小的管芯，但仍然能够保持负责的独特位置 减少学习曲线。最后通过与原药的对比研究来验证其疗效。 Glidescope AVL 早产儿/幼儿插管装置。 2016年，美国经口气管插管市场规模约为4.35亿美元，预计将达到619.8美元 到 2023 年，预计将实现 5.1% 的复合年增长率。 2012 年出生的 3,304,364 名新生儿中 美国，当年 7.2%（即 237,914 名婴儿）入住 NICU，其中 25% 需要插管 呼吸支持（约 60,000 名新生儿插管）。由于儿科市场竞争有限，Brio 预测以每台 300 美元的价格销售 2,000 台一次性 NAVS，总收入为 600,000 美元 销售的第一年。与 Brio 的 INT NavigatorTM 和相关插管产品结合使用时，总 预计上市五年后利润将达到 3000 万美元以上。