Shape memory alloys (SMAs) have found widespread applications as biomedical devices. Biocompatibility, corrosion resistance, and ductility make these alloys attractive for medical devices such as stents and filters. For these implants, the superelastic property is the primary function of SMAs. Additionally, these alloys, such as NiTi as the prime example, can be used for actuation. Several modes of actuation such as displacement control, force control, and compliance control have been used as harnesses with SMA devices. These two unique properties have opened another application in the form of neurosurgery and robot-assisted surgery devices, as well as controlled assistive and rehabilitation devices. This paper reviews the state of the art of application of SMAs in the latter category where control is applied to harness innovative medical devices. To this end, two major subsets of these devices: prosthesis and orthosis which take the advantage of SMAs in assistive and rehabilitation devices are studied. These devices are further categorized to hand prosthetics, elbow, knee and ankle orthotics. In most of these designs, SMA wires act as artificial muscles to mimic the motion of limbs in the target joints. The evolution of each category is explained, and the specific results of them are reported. The paper also reviews the SMA applications for neurological and neuromuscular rehabilitation. To this end, different categories of rehabilitation devices as a passive and aided exercise for the ankle, knee, and elbow are highlighted. The SMA actuator in these devices can be EMG-controlled to improved patient outcome. In addition to providing a comprehensive overview of the biomedical devices, this paper identifies several possible future directions of SMA related research in the area of assistive and rehabilitation devices.

The use of titanium bone fixation plates is considered the standard of care for skeletal reconstructive surgery. Highly stiff titanium bone fixation plates provide immobilization immediately after the surgery. However, after the bone healing stage, they may cause stress shielding and lead to bone resorption and failure of the surgery. Stiffness-modulated or stiffness-matched Nitinol bone fixation plates that are fabricated via additive manufacturing (AM) have been recently introduced by our group as a long-lasting solution for minimizing the stress shielding and the follow-on bone resorption. Up to this point, we have modeled the performance of Nitinol bone fixation plates in mandibular reconstruction surgery and investigated the possibility of fabricating these implants. In this study, for the first time the realistic design of stiffness-modulated Nitinol bone fixation plates is presented. Plates with different levels of stiffness were fabricated, mechanically tested, and used for verifying the design approach. Followed by the design verification, to achieve superelastic bone fixation plates we proposed the use of Ni-rich Nitinol powder for the AM process and updated the models based on that. Superelastic Nitinol bone fixation plates with the extreme level of porosity were fabricated, and a chemical polishing procedure used to remove the un-melted powder was developed using SEM analysis. Thermomechanical evaluation of the polished bone fixation plates verified the desired superelasticity based on finite element (FE) simulations, and the chemical analysis showed good agreement with the ASTM standard.