helping patients when their breathing is at risk
During sedation or altered levels of consciousness, the jaw can relax allowing the tongue and soft tissues to obstruct the airway. This can result in catastrophic consequences such as cardiac arrest and severe hypoxemic brain damage. Currently, a patient’s airway must be continually monitored by a trained staff member because there are no standard airway support devices.
The University of Michigan has developed Airway Cradle, a low cost, disposable, adjustable, hands-free device that will serve as a replacement for the manually performed Jaw Thrust Maneuver.
Airway Cradle offers fast implementation and removal and can also be designed with ports or clips that allow for the provision of oxygen as well as carbon dioxide monitoring.
Significant Need
Presently, there are no universally used standard airway support devices for patients experiencing procedural sedation, general anesthesia, or altered mental status due to alcohol/drug intoxication.
Competitive Advantage
Airway Cradle negates the need for someone to actively hold the jaw forward and is non-invasive, so there is no risk of nose bleed, aspiration, or invoking a gag reflex and vomiting—side effects caused by current standard of care options.
Commercialization Path
- Intellectual Property – Patent filed
- Commercialization Strategy – Manufacturer relationship formed, given approval to proceed
- Regulatory Pathway – Class 1 Medical Device, 510K exempt
- Engage Investors – Use study data to seek additional investment and licensing opportunities
- Product Launch Strategy – Multiple licensing opportunities to anesthesia and medical device companies
Milestones
- Develop prototype
- Obtain IRB approval
- Submit design to manufacturer
- Produce “final” prototype batch
- Test device on patients to confirm functionality, then continue testing including use with Ambu bag
- Incorporate design feedback
- Engage industry partners
- Negotiate license agreement
- Prepare for production
