This application requests support to successfully develop a unique, patentable, medical device for use in chest physiotherapy. The device stimulates mucous transport rates and mucociliary clearance.
The specific aim of this project is to design, construct, and conduct animal testing of the device. Testing will be done in the sheep with measurements of mucous transport rates, lung clearance, recovery of mucous, and respiratory function. The objectives of these experiments will be to: develop specifications for the device; determine which parameters are important to the biological response; and produce the most efficient and practical device - subject interphase. A Phase II application will follow that will provide for manufacture of prototypes for use in the clinical testing phase. The clinical trials will be designed to duplicate in man the results obtained in the sheep. The study population will consist of patients with normal mucus production but impaired mucociliary clearance such as postoperative patients, and patients with copious mucus production such as those with chronic bronchitis and cystic fibrosis. This device will have wide clinical applications in acute care, extended care, and in the home. It could favorably impact on health care costs by decreasing the need for and duration of hospitalization for acute or extended care. A Phase III business plan will be prepared to successfully commercialize this invention.
| Rubin, E M; Scantlen, G E; Chapman, G A et al. (1989) Effect of chest wall oscillation on mucus clearance: comparison of two vibrators. Pediatr Pulmonol 6:122-6 |
