Design of a Safe Active Orthosis for Full Assistance of the Human Knee Joint

Ensuring user safety while enabling independent mobility is crucial to autonomous healthcare and rehabilitation robots, such as active lower-limb orthoses and exoskeletons. A key requirement for these devices is to provide full assistance without supervision; however, existing designs do not simultaneously satisfy autonomous operation and inherent safety. To address this gap, a novel safety principle, Safety by Design, and a corresponding system architecture for a fully assistive active knee orthosis are introduced. The proposed architecture is based on a comprehensive risk analysis for the use of active orthoses and exoskeletons and integrates redundancies for all safety-critical components while minimizing additional weight. This redundancy enables the orthosis to remain operational at reduced power in the event of component failure, improving both user safety and system reliability. The design supports safe, unsupervised operation by ambulatory users, enhancing independent patient mobility and the performance of the gait activities of level walking, stair climbing and sitting down/standing up. The proposed architecture is scalable and adaptable to a wide range of robotic devices. By improving robustness, efficiency, and safety, this work contributes to the advancement of autonomous biomedical robotic systems and wearable assistive devices.