可攜式生物回饋與電刺激吞嚥訓練治療儀之研發與臨床應用

Dysphagia, swallowing dysfunction, is a common clinical problem in our society. It is commonly seen in stroke patients and/or some patients with oesophagus cancer. Although the electrical stimulation (ES) has been used for assisting the swallowing function, less ES system with the functions of physiological signal biofeedback and interesting animation has been developed. The aim of this project is to commercialize a portable FES system with biofeedback for swallowing therapy. This system is a game-based high quality product with advantages of cost-efficiency and personalization characteristic. It is intended for use in patients with dysphagia. This system can detect the surface electromyography (sEMG) of submental muscle and the movement of thyroid cartilage using accelerometer. Those biofeedback signals are used for controlling audiovisual frog animation to encourage swallowing. The electrical stimulation current can be automatically delivered to throat region for assisting the swallowing function when patient cannot perform complete swallowing. The aim of the project contains going through the following works: First year: patent analysis and application, hardware design and fabrication, audiovisual animation design, and quality management system establishment. Second year: product safety certification, quality management system establishment, and clinical trials. Third year: to accomplish clinical trials. It is believed that our detailed market analysis, advanced engineering technology as well as solid clinical trials should successfully commercialize the medical device. The experience of our successful case should attract more companies to further invest in medical device industry. The proposed device can be extended to create more innovational medical device which need physiological signal biofeedback and interesting animation.