Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light Scattering Modules for Carpal Tunnel Syndrome Treatment and Surgical Procedure

A novel technique and product applied to carpal tunnel microscopic surgical procedures through the designed medical devices were prepared and studied. The novel design of the medical device could be developed and applied for new carpal tunnel microscopic surgical procedures instead of the traditional carpal tunnel surgical procedures. Also, a new medical device with optical LLLT module was designed for wound healing in carpal tunnel syndrome treatments. Furthermore, assistive surgical healing dressings for carpal tunnel syndrome treatments via minimally invasive surgery (MIS) such as air-foam soft cleaning sponges and hydrogel surgical dressings with polymeric films were designed for more comfortable treatments. Biological and clinical evaluations of carpal tunnel surgical procedure using the new designed medical devices are studied. For commercialized reasons, guidance such as ISO 10993-1:2009(E) for biological evaluation of medical devices must be considered. Furthermore, the clinical evaluation of modified medical devices would be carried out.