The beginning of a new era in bone surgery Effectiveness and clinical application of a cold-ablation and robot-guided laser osteotome

Most industrial laser applications utilize computer and robot assistance, for guidance, safety, repeatability, and precision. For industrial applications, the increase in throughput and the processing speed are in the foreground. Nevertheless, these tools cannot just be transferred into clinical and surgical use because the focus in surgical interventions is on the exact implementation of a unique plan. The patient, as an inaccurately defined workpiece, with its individual anatomy and pathology, ultimately needs a single lot planning. Nowadays, medical laser systems are hand driven. The possibility of working precision, as used in industry lasers, is not exhausted. Therefore, medical laser beams have to be coupled to robot guidance. But due to the over-size of commercially available tools, efficient and ergonomic work in an operating room is impossible. Integration of the systems such as the laser source, and the robot arm are needed. Another key issue for the accuracy of the robotic arm is the inclusion of a tracking system. All these issues were encountered developing CARLO®: a Cold-Ablation and Robot-guided Laser Osteotome. This PhD thesis is divided in three parts: - an in-vivo study in sheep, - an in-vitro / wetlab study on human cadavers, and - a theoretical-experimental study to evaluate biomechanical changes in different osteotomy pattern. To test the applicability of the system in an operation theatre similar environment, an in-vivo animal trial was performed. Additionally, we wanted to demonstrate that bone healing after laser osteotomy is not impaired compared to the standard tool the piezo-osteotome. In terms of new mineralized bone formation, histological and micro-CT analysis showed clearly a higher tendency towards the acceleration of the healing process in the laser group. Additionally, no signs of bone necrosis were seen. In addition to the pure functioning of the device, the applicability in the clinic is important for technology to prevail. Therefore, dummy tests for the ergonomics and cadaver tests for the simulation of "real" operations in the cranio-maxillofacial field were performed. Wetlab tests were conducted on human cadavers where different macro-retentive osteotomy patterns were performed. It could be demonstrated that our prototype shows advantages over the current state of the art cutting tools, e.g. reduced bone loss, precise and real-time navigated execution of predefined geometries of freely selected osteotomy patterns. This advantage can be implemented in another indication of our prototype in the cranio-maxillofacial field: in craniosynostosis surgery. We performed a study using finite element analysis to simulate incomplete osteotomies on the inner side of the bone flap to facilitate the re-shaping (skull molding). This biomechanical analysis intended to create basic knowledge in terms of the best stress vs. force relation to obtain the largest projected bone surface. Moreover, a human multicenter study is ready to start for the clinical introduction of the cold-ablation and robot-guided laser osteotome and to gain more experience and information for future work