The Development of a Novel Device Based on Loss of Guidewire Resistance to Identify Epidural Space in a Porcine Model

Abstract

Background. The application of additive manufacturing (3D printing) has been recently expanded to various medical fields. The new technique named loss of guide wire resistance (LOGR) was developed via 3D printing for the detection of epidural space using a guide wire instead of air or saline used in the loss of resistance (LOR) technique. Methods. The prototype model of epidural space finder consists of a polyactic acid (PLA) or a resin. It was manufactured with 3D printing. Biocompatibility test (eluate and sterility tests) was performed in both products. The advantage of the newly developed device was compared with conventional loss of resistance (LOR) technique in a porcine model. Results. Eluate and sterility tests revealed that the PLA was more biocompatible than the resin. The LOGR technique facilitated rapid access to epidural space compared with the LOR technique (41.64 ± 32.18 vs. 92.28 ± 61.46 seconds, N = 14, p=0.0102, paired sample t-test), without any differences in success rate (87.5%). Conclusion. We conclude that LOGR technique is comparable to LOR technique to access the epidural space, although the advantage of either technique in terms of complications such as dural puncture or epidural hematoma is unknown. We demonstrated the potential benefit of 3D printer for the development of a new medical device for anesthesia.