Polymer-based capacitive strain gauges are a novel and promising concept for measuring large displacements and strains in various applications. These novel sensors allow for high strain, well above the maximum values achieved with state-of-the-art strain gauges (Typ. 1%). In recent years, a lot of interest in this technology has existed in orthopedics, where the sensors have been used to measure knee laxity caused by a tear of the anterior cruciate ligament (ACL), and for other ligament injuries. The validation of this technology in the field has a very low level of maturity, as no fast, reproducible, and reliable manufacturing process which allows mass production of sensors with low cost exists. For this reason, in this paper, a new approach for the fabrication of polymer-based capacitive strain gauges is proposed, using polydimethylsiloxane (PDMS) as base material. It allows (1) the fast manufacturing of sensor batches with reproducible geometry, (2) includes a fabrication step for embedding rigid electrical contacts on the sensors, and (3) is designed to produce sensor batches in which the size, the number, and the position of the sensors can be adapted to the patient's anatomy. In the paper, the process repeatability and the robustness of the design are successfully proven. After 1000 large-strain elongation cycles, in the form of accelerated testing caused much higher strains than in the above-mentioned clinical scenario, the sensor's electrical contacts remained in place and the functionalities were unaltered. Moreover, the prototype of a patient customizable patch, embedding multiple sensors, was produced.
Keywords: ACL rupture; Carbon black-PDMS; PDMS; batch fabrication; electronic contacting; flexible sensor mold fabrication; knee joint.