BRIO DEVICE, LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Over 3 million emergency intubations are performed in

Description

DESCRIPTION (provided by applicant): Over 3 million emergency intubations are performed in the US every year and failure rates can be as high as 50% (3-5). Success is highly dependent on how frequently the responder performs this life-saving procedure on humans (6). Brio Device, LLC, an airway management medical device company, is addressing the need to decouple the success of the procedure from the experience of the user with their smart intubation device which integrates anatomic structure recognition algorithms and visual guidance feedback with an articulating stylet. Brio's intubation device is specifically designed fo the needs of emergency responders, such as paramedics, emergency department personnel, code teams in hospitals and military medics, whooften arrive at the patient first. The smart intubation device will reduce failure rates by providing the user with visual instruction of the correct path to the trachea as he places the endotracheal tube. The guidance software uses machine learning and computer vision algorithms to recognize the anatomy and determine the path to insert the tube. Ultimately, the intubation device will include both a guidance display on an LCD screen and an optical stylet that has single-axis angulation control of the distal tip. For the purpose of this Phase I study, a laptop or desktop computer will be used for the image processing and the guidance display that accompanies the articulating stylet. The long-term goal is to create a device that is compact, light-weight and portable to suit the needs of ambulances and hospital crash carts. The hypothesis for this study is that by incorporating a video guidance display with an articulating stylet, inexperienced users will be more successful in correctly placing the endotracheal tube using this device compared to direct laryngoscopy. To achieve this goal, image processing and machine learning algorithms will be developed to recognize key anatomic structures in the airway. Software will also be developed determine the path the tube should follow and to display this information for the user. Finally, the efficacy of the device will be validated in airway simulation mannequins with medical students serving as the inexperienced users. Phase II will focus on integrating the guidance software, articulating optical stylet and display into a portable device with embedded hardware and software contained within the stylet handle. At completion of Phase II, the device will be ready for clinica trials and FDA testing. Brio will enter the 20billion airway market with its intubation device. Initial sales will begin with anesthesiologists who are early adopters of new technology to assist with difficult airways. Brio will market its product to ~327,000 clinicians who use intubation devices. The U.S. addressable market for emergency intubation is ~ 900M for the 41,000 ambulances and 5,800 emergency departments and hospital code teams. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: In this SBIR Phase I, Brio Device, LLC plans to create and evaluate a device that improves the success rate of emergency intubations by coupling a smart guidance display with a user-controlled single-axis articulating stylet. Emergency intubations are often performed in challenging situations by personnel who do the procedure infrequently. Since failure rates are as high as 50% and approximately 180,000 deaths occur each year from failed pre-hospital intubations, a device is needed to provide visual guidance information to assist the users and increase theirsuccess rates in emergency situations.