The MISLI-Drive, a modular sterilizable robotic driver for steerable laparoscopic instruments

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.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 Sterile 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 s.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

Visual force feedback in laparoscopic training

Background - To improve endoscopic surgical skills, an increasing number of surgical residents practice on box or virtual reality (VR) trainers. Current training is focused mainly on hand–eye coordination. Training methods that focus on applying the right amount of force are not yet available. Methods - The aim of this project is to develop a low-cost training system that measures the interaction force between tissue and instruments and displays a visual representation of the applied forces inside the camera image. This visual representation continuously informs the subject about the magnitude and the direction of applied forces. To show the potential of the developed training system, a pilot study was conducted in which six novices performed a needledriving task in a box trainer with visual feedback of the force, and six novices performed the same task without visual feedback of the force. All subjects performed the training task five times and were subsequently tested in a post-test without visual feedback. Results - The subjects who received visual feedback during training exerted on average 1.3 N (STD 0.6 N) to drive the needle through the tissue during the post-test. This value was considerably higher for the group that received no feedback (2.6 N, STD 0.9 N). The maximum interaction force during the post-test was noticeably lower for the feedback group (4.1 N, STD 1.1 N) compared with that of the control group (8.0 N, STD 3.3 N). Conclusions - The force-sensing training system provides us with the unique possibility to objectively assess tissuehandling skills in a laboratory setting. The real-time visualization of applied forces during training may facilitate acquisition of tissue-handling skills in complex laparoscopic tasks and could stimulate proficiency gain curves of trainees. However, larger randomized trials that also include other tasks are necessary to determine whether training with visual feedback about forces reduces the interaction force during laparoscopic surgery.Biomechanical EngineeringMechanical, Maritime and Materials Engineerin

Force measurement platform for training and assessment of laparoscopic skills

Background - To improve endoscopic surgical skills, an increasing number of surgical residents practice on box or virtual-reality (VR) trainers. Current training is mainly focused on hand–eye coordination. Training methods that focus on applying the right amount of force are not yet available. Methods - The aim of this project is to develop a system to measure forces and torques during laparoscopic training tasks as well as the development of force parameters that assess tissue manipulation tasks. The force and torque measurement range of the developed force platform are 0–4 N and 1 Nm (torque), respectively. To show the potential of the developed force platform, a pilot study was conducted in which five surgeons experienced in intracorporeal suturing and five novices performed a suture task in a box trainer. Results - During the pilot study, the maximum and mean absolute nonzero force that the novice used were 4.7 N (SD 1.3 N) and 2.1 N (SD 0.6 N), respectively. With a maximum force of 2.6 N (SD 0.4 N) and mean nonzero force of 0.9 N (SD 0.3 N), the force exerted by the experts was significantly lower.Biomechanical EngineeringMechanical, Maritime and Materials Engineerin

Probing forces of menisci: what levels are safe for arthroscopic surgery

Purpose To facilitate effective learning, feedback on performance during arthroscopic training is essential. Less attention has been paid to feedback on monitoring safe handling of delicate tissues such as meniscus. The goal is to measure in vitro probing forces of menisci and compare them with a theoretical maximum probing force (TMPF). Method Menisci samples of ten cadavers were mounted on force platforms to measure probing forces up to 20 N in three directions. Nineteen subjects participated: six novices (experience 60 arthroscopies), and three faculty (>250 a year). All had to perform three tasks on each meniscus sample with an arthroscopic probe: push three times on the superior meniscal surface, perform one continuous run on the superior meniscal surface, and push three times on the inferior meniscal surface. The absolute maximum probing force (AMPF) was determined for each condition. A multivariable linear regression analysis was performed to assess the influence of experience on the force magnitude (P < 0.05). AMPFs were compared to the TMPF (estimated to be 8.5 N). Results The AMPF of the push task was on average 2.8 N (standard deviation (SD) of 0.8 N), of the continuous run task 2.5 N (SD 0.9 N), and of the pull task 3.9 N (SD 2.0 N). Significant difference was present between experts and novices (P < 0.05). The AMPFs are in the same order of magnitude as the TMPF. Conclusion The results indicate the necessity of using a safety level for tissue manipulation when training arthroscopy and a value for is magnitude.Biomechanical EngineeringMechanical, Maritime and Materials Engineerin

An Isolator System for minimally invasive surgery: the new design

Background - The risk of obtaining a postsurgical infection depends highly on the air quality surrounding the exposed tissue, surgical instruments, and materials. Many isolators for open surgery have been invented to create a contained sterile volume around the exposed tissue. With the use of an isolator, a surgical procedure can be performed outside sterile environments. The goal of this study was to design an Isolator System (IS) for standard laparoscopic instruments while instrument movements are not restricted. Methods - The developed IS consists of a sleeve to protect the instrument shaft and tip and a special balloon to protect the incision and trocar tube. A coupling mechanism connected at the sleeve allows instrument changes without contamination of the isolated parts. Smoke tests were performed to show that outside air does not enter the new IS during a simulated laparoscopic procedure. Eight test runs and one baseline run inside a contained volume filled with thick smoke were performed to investigate whether smoke particles entered the Isolator System. Filters were used to identify smoke entering the Isolator System. Results - Seven filters showed no trace of smoke particles. In one test run, a part of the IS loosened and a small brown spot was visible. The filter from the baseline run was completely covered with a thick layer of particles, proving the effectiveness of the test. During all test runs, the isolated instrument was successfully locked on and unlocked from the isolated trocar. Instrument movements gave no complications. After removal of the isolated instrument, it took three novices an average of 3.1 (standard deviation (SD), 0.7) seconds to replace it correctly on the isolated trocar. Conclusions - The designed IS for laparoscopy can increase sterility in environments where sterility cannot be guaranteed. The current design is developed for laparoscopy, but it can easily be adapted for other fields in minimally invasive surgery.Biomechanical EngineeringMechanical, Maritime and Materials Engineerin

Design of a Box Trainer for Objective Assessment of Technical Skills in Single-port Surgery

Laparoscopic single-port (SP) surgery uses only a single entry point for all instruments. The approach of SP has been applied in multiple laparoscopic disciplines owing to its improved cosmetic result. However, in SP surgery, instrument movements are further restricted, resulting in increased instrument collisions compared with standard multiport (MP) laparoscopy. Our goal was to develop a trainer that can quantitatively measure task time, force and motion data during both MP and SP training to investigate the influence of instrument configuration on performance. Custom-made abdominal force sensors and accelerometers were integrated into a new training box that can be used in an SP and an MP configuration. This new box trainer measures forces, acceleration, and tilt angles during training of SP and MP laparoscopy. With the new trainer, 13 novices performed a tissue manipulation task to test whether significant differences exist between MP and SP in maximum abdominal force, maximum tissue manipulation force, maximum acceleration, and tilt angles of the handles. The results show that the task time (SP-145s, standard deviation (SD) = 103 vs MP-61s SD = 16), maximum abdominal force (SP-8.4N, SD = 2.0 vs MP-left (L)-3.3N, SD = 0.8 and MP-right (R)-5.8N, SD = 2.1), tissue manipulation force (SP-10.4N, SD = 3.6 and MP-5.6N, SD = 1.3), maximum acceleration (MP-L-9m/s(2), SD = 5 vs SP-L-14m/s(2), SD = 7), and tilt angles of the left handle are significantly higher in SP. This study shows that the new trainer can be used to find the most important differences in instrument and tissue handling, which is an important step toward the assessment of surgical skills needed for safe SP surgery depending on force and motion-based parameter

Validation of the portable virtual reality training system for robotic surgery (PoLaRS): a randomized controlled trial

Background: As global use of surgical robotic systems is steadily increasing, surgical simulation can be an excellent way for robotic surgeons to acquire and retain their skills in a safe environment. To address the need for training in less wealthy parts of the world, an affordable surgical robot simulator (PoLaRS) was designed. Methods: The aim of this pilot study is to compare learning curve data of the PoLaRS prototype with those of Intuitive Surgical’s da Vinci Skills Simulator (dVSS) and to establish face- and construct validity. Medical students were divided into two groups; the test group (n = 18) performing tasks on PoLaRS and dVSS, and the control group (n = 20) only performing tasks on the dVSS. The performance parameters were Time, Path length, and the number of collisions. Afterwards, the test group participants filled in a questionnaire regarding both systems. Results: A total of 528 trials executed by 38 participants were measured and included for analyses. The test group significantly improved in Time, Path Length and Collisions during the PoLaRS test phase (P ≤ 0.028). No differences was found between the test group and the control group in the dVSS performances during the post-test phase. Learning curves showed similar shapes between both systems, and between both groups. Participants recognized the potential benefits of simulation training on the PoLaRS system. Conclusions: Robotic surgical skills improved during training with PoLaRS. This shows the potential of PoLaRS to become an affordable alternative to current surgical robot simulators. Validation with similar tasks and different expert levels is needed before implementing the training system into robotic training curricula

Design and stepwise user evaluation of an ergonomic 2 DOF arthroscopic cutter

The goal of this study was to determine the preferred handle design for two degrees of freedom steerable arthroscopic cutter by performing a two-step development approach. The expected usefulness and usability of control components of three entirely different handles were defined by an on-line survey with 101 students and the actual control by a standardised laboratory study with mock-up models by 16 students. The preferred handle design was integrated in a full functional prototype and optimized by 10 experts performing a meniscectomy on human cadaver knees. Students (survey 70% and task 91%) expected the same control behaviour as the experts (60%): steering a wheel to the right should evoke tip steering to the right regardless the orientation of the beak and moving a ring lever towards the handle’s centre point should evoke closure of the tip. Development of surgical instruments can benefit from expected control behavior based on daily life tools, but requires expert involvement for specific surgical tasks and context

Video1_The MISLI-Drive, a modular sterilizable robotic driver for steerable laparoscopic instruments.MP4

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.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 Sterile 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 s.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.</p