The device was developed over a period of several years. Warters and Butler discussed a variety of configurations and had a local design engineering company build several prototypes until they met the inventors requirements. They then secured Institutional Review Board approval for use of the device in human subjects, added some safety features and initiated trials. Next they engaged the services of a device attorney and applied to the patent office. He expects the Food and Drug Administration approval to be straightforward since the device is a non-significant risk item.
Discussions continue with several companies to manufacture and distribute the product.
In the meantime, Phase I clinical trials continue at Hermann Hospital. About 65 children ages 4 through 9 are involved, and reception so far has been very favorable. A second device developed by Warters is a new intratrachial tube that provides improved cleansing of the lungs over standard tubes. Pneumonia can occur with patients who have to use a breathing tube for an extended period of time, he explained. The mechanical ventilation diminishes the lungs ability to cleanse themselves.