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Biomedical Devices: Overview
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
It is estimated that approximately 50,000 people died because of the human error [3]. From 2000 onward, robotics became a reality and began to be used in clinical procedures where extreme precision is critical. For example, a minor error in neurosurgery will lead to paralysis. NeuroArm combines MRI and a surgical robot to perform microsurgery and biopsy-stereotaxy with high precision [4].
Data analytics interrogates robotic surgical performance using a microsurgery-specific haptic device
Published in Expert Review of Medical Devices, 2020
Amir Baghdadi, Hamidreza Hoshyarmanesh, Madeleine P. de Lotbiniere-Bassett, Seok Keon Choi, Sanju Lama, Garnette R. Sutherland
A number of commercially available haptic hand-controllers are available [16–19], however these were not developed specifically for microsurgery and therefore do not address microsurgery-specific requirements of force feedback, handpiece properties, workspace, dexterity, or manipulability [10]. One major branch of haptic devices is PHANToM family by 3D Systems (Rock Hill, South Carolina). The Premium™ models of this hand-controller have a serial kinematic design with a range of motion equivalent to human wrist, providing a large workspace, but lower forces compared to a parallel kinematic design [17]. Another family of haptic devices are available through Force Dimension (Nyon, Switzerland) including three classes of Omega, Delta, and Sigma. Sigma 7 as their most advanced product offers a high force feedback capability and relatively larger workspace among the parallel linkage designs [20]. Other commercially available haptic hand-controllers include HD2 High Definition by Quanser Inc. (Markham, Canada) with a dual phantom kinematic design, as the economic version of Omega with less positional resolution and force capacity, and Virtuose™ 6D by Haption, GmbH (Aachen, Germany) [19,21,22]. These devices can provide up to 6 degrees-of-freedom (DOF) with a variable workspace and force feedback capabilities. However, their general-purpose design makes them inefficient for a delicate medical application. HapticMaster by MOOG Inc. (New York, USA) has design specifications exclusive for rehabilitation applications due to high impedance characteristics and larger workspace, however with a lower DOF [18,19]. Freedom 7 is another medical-specific device by MPB Technologies Inc. (Pointe Claire, Canada) with low inertia, low friction, high position resolution, and wide dynamic range, however a very low maximum continuous force application [16,19]. In order to overcome the limitations of existing systems and determine the features of a hand-controller that optimize user performance in surgical applications, our research group compared the Sigma 7 (hereafter called Sigma7), HD2 High Definition and PHANToM Premium™ 3.0 (hereafter called Premium) haptic devices in micromanipulation surgical tasks on a common test rig [19]. Based on the quantifiable performance measures obtained in this study, and with the inclusion of additional microsurgery-specific design requirements, a unique haptic hand-controller, neuroArmPLUSHD, was designed and developed at Project neuroArm, University of Calgary[23–25].