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.
In this SBIR Phase II, Brio Device, LLC will develop a neonatal-sized articulating video stylet (nAVS) for intubation based on the successfully development of an adult sized AVS in Phase I. The unique camera position and mechanical properties of the articulating stylet have reduced the procedural learning curve of this life-saving maneuver. The goal of Phase II is to accomplish the same usability but in a very small (<3mm diameter) stylet for use with neonates and pediatric patients. The expansion of procedural expertise to a larger clinical population will improve health care delivery for children in community hospitals, labor and delivery units and globally, where specialized pediatric care is otherwise unavailable- not only saving lives, but preventing devastating complications from hypoxic insults to a child's brain and body.
