Articulating Video Stylet for Improved Intubation Success Rates

项目摘要 在美国，每年进行超过2000万次插管，并且可能导致高的 手术相关和疾病相关并发症。儿童插管困难的发生率较高， 由于更多的前喉和先天性综合征的存在，导致20%的并发症 在气道管理期间和与气道管理相关。儿科患者插管困难最常见于 最小的儿童和那些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，已经花了数百个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。通过这项研究，Brio 解决了用户在开发第一阶段赠款的清晰视频探针（AVS）的需求。的能力 AVS可缩短学习曲线，使新手用户能够在首次尝试时快速成功插管 促使该公司追求新生儿大小的AVS（nAVS），该AVS解决了市场的高需求，但 缺乏可视插管工具 nAVS有三个关键组件，特别是摄像头在探针上的位置， 提供了功能头端与解剖结构、半刚性探针和关节连接能力的关系视图 其提供了气道空间中离体运动的一对一转换，从而使得易于进行微波激射， 最后是小于3mm的直径，这使得它可用于新生儿和较大的儿科患者。 第II阶段的目标是创建一个与成人AVS相同可视化的3 mm以下探针， 机械性能已被证明可使Brio的INT实现成功的首过插管 Navigator ™关节头探针和AVS。为了实现这一目标， 将设计探针并进行台架测试，直至达到与成人AVS相似的刚度和关节连接。光学器件 也将设计为适合这种非常小的探针，但仍然能够保持独特的位置， 缩短学习曲线。最后，将通过与 Glidescope AVL早产儿/幼儿插管装置。 2016年，美国经口气管插管市场约为4.35亿美元，预计将达到6.198亿美元。 到2023年，预计年复合增长率为5.1%。在2012年出生的3 304 364名新生儿中， 在美国，7.2%（或237，914名婴儿）在该年入住NICU，25%需要插管， 呼吸支持（约60 000例新生儿插管）。由于儿科市场的竞争有限，Brio 预计以300美元/台的价格销售2,000台一次性nAVS装置，总收入为60万美元。 销售的第一年。当与Brio的INT NavigatorTM和相关插管产品结合使用时， 在市场上五年后，预计利润将达到3000多万美元。

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.