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.

项目摘要 每年在美国进行超过2000万个插管 程序有关和疾病有关的并发症。儿童插管困难的较高事件是 由于喉部的喉部和先天性综合征的存在，导致20％遭受并发症 在呼吸道管理期间。小儿患者的困难插管最常见 最小的孩子和那些有多次直接喉镜检查的人。 Brio Device，LLC，气道 管理医疗设备公司已经花费了数百小时的初级和二级研究 确定当前技术限制插管成功率的差距。从这项研究中，Brio有 在为I阶段授予的开发表达视频样式（AVS）时，可以满足用户的需求。能力 AVS减少学习曲线，并使鼻子用户能够快速插管，并在第一次尝试时进行插管 已驱使公司追求新生儿大小的AVS（NAVS），该AVS（NAVS）解决了需要的市场，但有 视觉插管工具的死亡。 NAV有三个关键组件，特别是相机在样式上的位置 提供了与解剖学，半刚性样式和发音能力有关的功能提示的视图 它提供了气道空间中的活体运动的一对一翻译，从而使男性易于 最后，直径低于3mm，它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种低于3mm的样式，具有与成人AV相同的可视化 被证明可以通过Brio的Int成功获得第一频道插管的机械性能 Navigator™发音风格和AVS。为了实现这一目标， 风格将经过设计和替补测试，直到达到与成人AV相似的刚性和表达。光学 还将旨在适合这种非常小的风格，但仍然能够保持负责的独特位置 减少学习曲线。最后，将通过与 GlideCope AVL早产/小儿童插管装置。 2016年，美国的气管插管市场约为4.35亿美元，估计达到619.8美元 到2023年，百万美元，在预测期内为5.1％的复合年增长率。在2012年出生的3,304,364名新生儿中 美国，当年有7.2％（或237,914个婴儿）被送入NICU，25％需要Intube 呼吸支持（约60,000个新生儿插管）。竞争有限，为这个小儿市场服务，Brio 预测以每单位300美元的价格出售2,000个一次性NAVS单位，总收入为60万美元 销售的第一年。与Brio的Int Navigatortm和相关插管产品结合使用时， 在市场上五年后，预测300万美元的利润将被预测。