Purpose Current surgical robotic systems are either large serial arms, resulting in higher risks due to their high inertia and no inherent limitations of the working space, or they are bone-mounted, adding substantial additional task steps to the surgical workflow. The robot presented in this paper has a handy and lightweight design and can be easily held by the surgeon. No rigid fixation to the bone or a cart is necessary. A high-speed tracking camera together with a fast control system ensures the accurate positioning of a burring tool. Methods The capabilities of the robotic system to dynamically compensate for unintended motion, either of the robot itself or the patient, was evaluated. Therefore, the step response was analyzed as well as the capability to follow a moving target. Results The step response show that the robot can compensate for undesired motions up to 12 Hz in any direction. While following a moving target, a maximum positioning error of 0.5 mm can be obtained with a target motion of up to 18 mm/s. Conclusion The requirements regarding dynamic motion compensation, accuracy, and machining speed of unicompartmental knee arthroplasties, for which the robot was optimized, are achieved with the presented robotic system. In particular, the step response results show that the robot is able to compensate for human tremor.
Robotic surgical systems reduce the cognitive workload of the surgeon by assisting in guidance and operational tasks. As a result, higher precision and a decreased surgery time are achieved, while human errors are minimised. However, most of robotic systems are expensive, bulky and limited to specific applications.In this paper a novel semi-automatic robotic system is evaluated that offers the high accuracies of robotic surgery while remaining small, universally applicable and easy to use. The system is composed of a universally applicable handheld device, called Smart Screwdriver (SSD) and an application specific kinematic chain serving as a tool guide. The guide mechanism is equipped with motion screws. By inserting the SSD into a screw head, the screw is identified automatically and the required number of revolutions is executed to achieve the desired pose of the tool guide.The usability of the system was evaluated according to IEC 60601-1-6 using pedicle screw implementation as an example. The achieved positioning accuracies of the drill sleeve were comparable to those of SpineAssist from Mazor Robotics Ltd., Caesarea (IL) with -0.54 ± 0.93 mm (max: 2.08 mm) in medial/lateral-direction and 0.17 ± 0.51 mm (max: 1.39 mm) in cranial/caudal-direction in the pedicle isthmus. Additionally, the system is cost-efficient, safe, easy to integrate in the surgical workflow and universally applicable to applications in which a static position in one or more DOF is to be adjusted.
Purpose Cooperative surgical systems enable humans and machines to combine their individual strengths and collaborate to improve the surgical outcome. Cooperative telemanipulated systems offer the widest spectrum of cooperative functionalities, because motion scaling is possible. Haptic guidance can be used to assist surgeons and haptic feedback makes acting forces at the slave side transparent to the operator, however, overlapping and masking of forces needs to be avoided. This study evaluates the usability of a cooperative surgical telemanipulator in a laboratory setting. Methods Three experiments were designed and conducted for characteristic surgical task scenarios derived from field studies in orthopedics and neurosurgery to address bone tissue differentiation, guided milling and depth sensitive milling. Interaction modes were designed to ensure that no overlapping or masking of haptic guidance and haptic feedback occurs when allocating information to the haptic channel. Twenty participants were recruited to compare teleoperated modes, direct manual execution and an exemplary automated milling with respect to usability. Results Participants were able to differentiate compact and cancellous bone, both directly manually and teleoperatively. Both telemanipulated modes increased effectiveness measured by the mean absolute depth and contour error for guided and depth sensitive millings. Efficiency is decreased if solely a boundary constraint is used in hard material, while a trajectory guidance and manual milling perform similarly. With respect to subjective user satisfaction trajectory guidance is rated best for guided millings followed by boundary constraints and the direct manual interaction. Haptic feedback only improved subjective user satisfaction. Conclusion A cooperative surgical telemanipulator can improve effectiveness and efficiency close to an automated execution and enhance user satisfaction compared to direct manual interaction. At the same time, the surgeon remains part of the control loop and is able to adjust the surgical plan according to the intraoperative situation and his/her expertise at any time.
Objectives Since the 1980s, robotic arms have been transferred from industrial applications to orthopaedic surgical robotics. Adverse events are frequent and often associated with the adopted powerful and oversized anthropomorphic arms. The FDA’s 510(k) pathway encourages building on such systems, leading to the adoption of hazards, which is known as “predicate creep”. Additionally, the methodology of hazard identification for medical device development needs improvement. Methods We present an approach to enhance general hazard identification and prevent hazards of predicate creep by using the integrative, scenario-based and multi-perspective Point-of-View (PoV) approach. We also present the Catalogue of Hazards (CoH) as an approach for collecting and systematising hazards for future risk analysis and robot development. Results We applied seven predefined PoVs to the use case of robotic laminectomy and identified 133 hazards, mainly coming from HMI analysis and literature. By analysing the MAUDE and recalls databases of the FDA, we were able to classify historical hazards and adopt them into the use case. Conclusions The combination of PoV approach and CoH is suitable for integrating multiple established hazard identification methods, increasing comprehensiveness, and supporting the systematic and hazard-based development of surgical robots.
Surgical robots have been introduced in the field of Computer Assisted Surgery (CAS) to assist the surgeon by providing an accurate link between the computer-based plan and the exact (a) positioning or (b) dynamic path control of an instrument on the operating site respectively. Whereas initial systems mostly have been based on an active supervisory control scheme of industrial robots with large universal workspaces, later on specialized miniaturized kinematics have been proposed, with restricted workspaces adapted to specific applications in order to ease handling and provide inherent safety properties. However, this specialization resulted in even narrower fields of application, low quantities and higher costs. Modularization seems to be a key factor to combine the benefits of both approaches. In this paper two modular robotic solutions, validated in the context of their purpose, are analysed regarding their modular design. Based on this, the potential of modularity for instrument guiding tasks in surgery is discussed.
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