The MILSI-Drive: Demonstration video's and datasets

Introduction: Based on the success of the former 'Shaft-Actuated, Tip-Articulated' SATA-Drive, a prototype robotic instrument driver for modular, steerable, laparoscopic instruments, a new driver is designed and tested to improve previously lacking features concerning cleanability, instrument adaptation, practical application and control. The design of the driver engages these issues with a modular design aimed at re-use of both the instrument and the driver, for which a set of design requirements are established. General re-use of medical devices, as well as the ability to selectively purchase, combined with a focus on low production costs, should reduce the overall cost of robotic surgery, making it more accessible.Methods: A new modular design has been developed to improve cleanability through separation of the electro-motors and the instrument mechanism which clutches the instrument. Contamination of the driver's robotic side is prevented though a combination of a drape and a sterilizable barrier interface, while the instrument side is made sterilizable. A novel instrument clutching mechanism enables quick-release features, while a motor-axis latching mechanism enables plug-and-play assembly. Embedded sensors allow precise and fast control. A user-experiment was conducted on instrument exchange and assembly time, while mechanical and electrical tests were conducted on the driver's responsiveness.Results: The driver has proven its ability to control the instrument, after which it can be disassembled for cleaning and inspection. The driver is designed for re-use through disassembled sterilization where all possibly contaminated surfaces are exposable for cleaning and inspection. The new standardized instrument clutches allow easy instrument (dis-)assembly. Instrument exchange is possible in two methods, the fastest of which is a median of 11 (6.3-14.6) seconds. The driver's instrument mechanism is separated in a median of 3.7 (1.8-8.1) seconds. After assembly, the driver is operational in less than 2 seconds.Discussion: Instrument exchange times are similar to the semi-reusable Da Vinci systems, yet the MISLI-Drive is designed for sterilization, inspection and continual re-use. The modular build of the driver also allows easier parts replacement during maintenance, and requires minimal adaptation to different future scenarios, which is expected to reduce the overall cost of use.

引言：基于此前“轴驱动、尖端铰接”（Shaft-Actuated, Tip-Articulated，SATA）驱动器——一款用于模块化、可转向腹腔镜器械（laparoscopic instruments）的原型机器人器械驱动器——的成功，本研究设计并测试了一款新型驱动器，旨在改进其先前在清洁性、器械适配性、实际应用及控制方面缺失的特性。该驱动器采用模块化设计以解决上述问题，目标是实现器械与驱动器的复用，并为此建立了一套设计要求。医疗设备的通用复用能力、选择性采购能力，结合对低生产成本的关注，有望降低机器人手术的总体成本，使其更易普及。

方法：新型模块化设计通过分离电机与器械夹持机构来提升清洁性。驱动器的机器人侧通过无菌屏障布（drape）与可灭菌接口屏障的组合防止污染，而器械侧则具备可灭菌性。新颖的器械夹持机构实现了快速释放功能，电机轴锁存机构则支持即插即用组装。嵌入式传感器可实现精准快速控制。研究开展了用户实验以测试器械更换与组装时间，并通过机械及电气测试评估驱动器的响应性。

结果：该驱动器已证实具备器械控制能力，且可拆解进行清洁与检查。其设计支持通过拆解灭菌实现复用，所有可能受污染的表面均可暴露以便清洁与检查。新型标准化器械夹具支持器械的便捷拆装。器械更换有两种方式，其中最快方式的中位时间为11秒（范围6.3-14.6秒）。驱动器器械机构的分离中位时间为3.7秒（范围1.8-8.1秒）。组装完成后，驱动器可在2秒内投入使用。

讨论：器械更换时间与半复用达芬奇系统（Da Vinci systems）相近，但MISLI-Drive设计支持灭菌、检查及持续复用。模块化结构使维护时部件更换更便捷，且对未来不同应用场景的适配需求最小化，预计可降低总体使用成本。