Development of Surrogate Biomedical Knee Implants for Validation of Embedded Smart Sensors

Total Knee Replacement (TKR) is a very common procedure in the United States, especially with the aging population. However, despite high numbers of procedures and advancing technology, about 20% of patients with TKR are unsatisfied with the level of discomfort they experience with their replacement. Prevailing theories suggest that this is due to gradual misalignment of the knee. Multiple methods have been attempted to detect the cause of mechanical failure in replacements. One possible method for performing state detection in knees is the embedding of piezoelectric transducers (PZTs) into the bearing component. Preliminary testing of PZT’s embedded in simplified plastic components has shown that this method contains promise. With this said, further testing on realistic knee implant components is still needed to solidify the method’s validity. Commercial knee implant bearings utilize medical grade Ultra-High Molecular Weight Polyethylene (UHMW) and manufacturers utilize proprietary processing technology to develop the final components. This work focuses on the development of surrogate knee implant prototypes that replicate the material and geometric properties of actual knee implants to provide a convenient and economical solution to evaluate the performance of embedded PZTs. In this work, scans of an original knee bearing are taken and used to create a 3D model. From there, a variety of processes including 3D printing and Computer Numerical Controlled (CNC) machining are used to develop surrogate prototypes that are compared for accuracy to a benchmark. This benchmark is taken as a polished CNC machined non-medical grade UHMW prototype. Standards that the prototypes must meet include cost and time effectiveness as well as similarity in geometry and material property to the benchmark. The performance of the prototypes is experimentally compared through mechanical load testing by using pressure sensitive films placed between the femoral and bearing components of the implant as well as measuring piezoelectric output. In addition, the measured voltage output is compared to predictions from an analytical model for validation of the piezoelectric performance. These two experiments help to derive information about the applied load distribution and location, allowing comparisons to be made to the benchmark. This study shows that, while some types of 3D printing, such as fused deposition modeling, provide fast and cheap prototypes, other options such as stereolithography printing produce higher quality and more replicative components. Results of this study can be used in the development of useful surrogates for the advancement of biomedical sensors.