A new modular mechanism that allows full detachability and cleaning of steerable laparoscopic instruments
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Abstract
Background: Ever since the introduction of laparoscopic surgery, researchers have been trying to add steerability to instruments to allow the surgeon to operate with better reachability and less tissue interaction force. Traditional solutions to introduce this often use a combination of springs, cables, pulleys, and guiding structures, resulting in instruments that cannot be properly cleaned and thus are very costly to manufacture and maintain. The aim of the study is to develop a novel affordable, sustainable, cableless, and fully steerable laparoscopic grasper, and to test its ease of assembly, disassembly, and use. Methods: A set of requirements was defined to ensure that the instrument can be handled efficiently at the sterilization unit and in the operating room. Based on these, a multisteerable, cableless 5 mm laparoscopic instrument that operates based on shaft rotations was developed. To test its assembly and disassembly, ten participants were asked to fully dismantle the instrument and reassemble it a total of 60 times. In addition, ten medical students were asked to use the grasper in the ForceSense box-trainer system on a newly developed 3D pick-and-place task, to determine the control effort based on learning curves of steering errors, task time, instrument path length, and maximum tissue interaction force. Results: All important design requirements were met. The recorded data indicates that ten engineering students were able to fully dismantle and reassemble the instrument shaft in 12 s (SD7) and 65 s (SD43) seconds at the sixth attempt. The learning-curve data indicates that three attempts were needed before the ten medical students started to use all steering functions. At the sixth attempt, on average only 1.25 (SD0.7) steering errors were made. The steepest slope in the learning curves for steering errors, path length, and task time was experienced during the first three attempts. In respect of the interaction force, no learning effect was observed. Conclusion: The multi-DOF (degree of freedom) cableless grasper can be assembled and disassembled for cleaning and sterilization within an acceptable time frame. The handle interface proved to be intuitive enough for novices to conduct a complex 3D pick-and-place task in a training setting.