Over 20 million intubations are performed in the US every year. Depending on setting and skill of the clinician, the failure rates range from 2% - 40%, resulting in approximately two million failures every year. The consequences of these failed intubations range from damaged vocal cords to death. 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. The two main capabilities lacking in existing intubation devices are (a) the ability to actively steer the tube through the anatomy and (b) continuous visualization of the tube throughout the procedure. Such a device needs to be designed for use in the operating room, critical care and emergency department, as well as emergency intubations in the field. Brio Device is addressing user needs by developing an articulating video stylet (AVS). The two critical components of the AVS are the optimal positioning of the camera on the stylet for intuitive user orientation and the articulating tip of the stylet. The camera position provides a continuous view of the articulating stylet tip during the process of inserting the endotracheal tube, therefore also providing visual confirmation of proper tube placement. The image displayed on a video screen gives visual feedback as the user changes the tip position with a thumb control on the handle while advancing the stylet through the airway. Not only does this intuitively orient the user, it also prevents the user from damaging the patient's airway as they advance the stylet and tube. The long-term goal is to create a device that has the articulation and a visual capability appreciated in bronchoscopes but is designed specifically for the intubation procedure, thus making it easier to learn to insert the endotracheal tube correctly and faster than with a bronchoscope. The goal for Phase I is to optimize the camera position on the AVS and verify that it improves intubation proficiency and first-attempt success rates. To achieve this goal, an optimization of the camera position will be performed to find the least obstructed view over the maximum portion of the stylet articulation range. Two of the optimal camera positions will be evaluated in a learning curve study in simulation mannequins to determine which view provides users with the best spatial orientation. Finally, the efficacy of the AVS over bronchoscope intubation will be tested by medical students intubating simulation mannequins with both devices. Successful intubation, time to intubation and number of attempts will be evaluated. Brio enters a $1B intubation market segment of the $20B US airway management market. Anesthesiology composes 94% of the intubation market and 80% of complications during anesthesia are due to airway mishaps. Brio will target the US market with paramedics in the ~47,000 ambulances and intubating clinicians within operating rooms, emergency departments and hospital code teams across ~5,700 hospitals. Sales of the AVS 510(k) Class II device to commence in Q4 2016 and exceed $50M revenue by 2020.
In this SBIR Phase I, Brio Device, LLC plans to develop an articulating video stylet (AVS) and evaluate improvements in intubation success rates when compared to devices used for difficult intubations. This AVS device couples user-controlled single-axis articulation of the stylet tip with continuous visualization of the stylet tip during tbe insertion, enabling the user to actively steer the endotracheal tube through the anatomy under constant visualization of the tip and visually confirm the final proper position of the tube. With approximately two million intubation failures every year, this device is needed to increase success rates and provide a more definitive confirmation of correct placement of the tube, reducing incidence of brain damage and fatalities caused by failed intubation.
