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

Objective classification of residents based on their psychomotor laparoscopic skills

Background - From the clinical point of view, it is important to recognize residents’ level of expertise with regard to basic psychomotor skills. For that reason, surgeons and surgical organizations (e.g., Acreditation Council for Graduate Medical Education, ACGME) are calling for assessment tools that credential residents as technically competent. Currently, no method is universally accepted or recommended for classifying residents as ‘‘experienced,’’ ‘‘intermediates,’’ or ‘‘novices’’ according to their technical abilities. This study introduces a classification method for recognizing residents’ level of experience in laparoscopic surgery based on psychomotor laparoscopic skills alone. Methods - For this study, 10 experienced residents (>100 laparoscopic procedures performed), 10 intermediates (10– 100 procedures performed), and 11 novices (no experience) performed four tasks in a box trainer. The movements of the laparoscopic instruments were recorded with the TrEndo tracking system and analyzed using six motion analysis parameters (MAPs). The MAPs of all participants were submitted to principal component analysis (PCA), a data reduction technique. The scores of the first principal components were used to perform linear discriminant analysis (LDA), a classification method. Performance of the LDA was examined using a leave-one-out crossvalidation. Results - Of 31 participants, 23 were classified correctly with the proposed method, with 7 categorized as experienced, 7 as intermediates, and 9 as novices. Conclusions - The proposed method provides a means to classify residents objectively as experienced, intermediate, or novice surgeons according to their basic laparoscopic skills. Due to the simplicity and generalizability of the introduced classification method, it is easy to implement in existing trainers.Biomechanical EngineeringMechanical, Maritime and Materials Engineerin

Position-based dynamics simulator of vessel deformations for path planning in robotic endovascular catheterization

A major challenge during autonomous navigation in endovascular interventions is the complexity of operating in a deformable but constrained workspace with an instrument. Simulation of deformations for it can provide a cost-effective training platform for path planning. Aim of this study is to develop a realistic, auto-adaptive, and visually plausible simulator to predict vessels’ global deformation induced by the robotic catheter’s contact and cyclic heartbeat motion. Based on a Position-based Dynamics (PBD) approach for vessel modeling, Particle Swarm Optimization (PSO) algorithm is employed for an auto-adaptive calibration of PBD deformation parameters and of the vessels movement due to a heartbeat. In-vitro experiments were conducted and compared with in-silico results. The end-user evaluation results were reported through quantitative performance metrics and a 5-Point Likert Scale questionnaire. Compared with literature, this simulator has an error of 0.23±0.13% for deformation and 0.30±0.85mm for the aortic root displacement. In-vitro experiments show an error of 1.35±1.38mm for deformation prediction. The end-user evaluation results show that novices are more accustomed to using joystick controllers, and cardiologists are more satisfied with the visual authenticity. The real-time and accurate performance of the simulator make this framework suitable for creating a dynamic environment for autonomous navigation of robotic catheters

Real-time laser speckle contrast imaging measurement during normothermic machine perfusion in pretransplant kidney assessment

Objectives: Normothermic machine perfusion (NMP) provides a platform for pre-transplant kidney quality assessment that is essential for the use of marginal donor kidneys. Laser speckle contrast imaging (LSCI) presents distinct advantages as a real-time and noncontact imaging technique for measuring microcirculation. In this study, we aimed to assess the value of LSCI in visualizing renal cortical perfusion and investigate the additional value of dual-side LSCI measurements compared to single aspect measurement during NMP. Methods: Porcine kidneys were obtained from a slaughterhouse and then underwent NMP. LSCI was used to measure one-sided cortical perfusion in the first 100 min of NMP. Thereafter, the inferior renal artery branch was occluded to induce partial ischemia and LSCI measurements on both ventral and dorsal sides were performed. Results: LSCI fluxes correlated linearly with the renal blood flow (R2 = 0.90, p < 0.001). After renal artery branch occlusion, absence of renal cortical perfusion could be visualized and semiquantified by LSCI. The overall ischemic area percentage of the ventral and dorsal sides was comparable (median interquartile range [IQR], 38 [24−43]% vs. 29 [17−46]%, p = 0.43), but heterogenous patterns between the two aspects were observed. There was a significant difference in oxygen consumption (mean ± standard deviation [SD], 2.57 ± 0.63 vs. 1.83 ± 0.49 mLO2/min/100 g, p < 0.001), urine output (median [IQR], 1.3 [1.1−1.7] vs. 0.8 [0.6−1.3] mL/min, p < 0.05), lactate dehydrogenase (mean ± SD, 768 ± 370 vs. 905 ± 401 U/L, p < 0.05) and AST (mean ± SD, 352 ± 285 vs. 462 ± 383 U/L, p < 0.01) before and after renal artery occlusion, while no significant difference was found in creatinine clearance, fractional excretion of sodium, total sodium reabsorption and histological damage. Conclusions: LSCI fluxes correlated linearly with renal blood flow during NMP. Renal cortical microcirculation and absent perfusion can be visualized and semiquantified by LSCI. It provides a relative understanding of perfusion levels, allowing for a qualitative comparison between regions in the kidney. Dual-side LSCI measurements are of added value compared to single aspect measurement and renal function markers.Medical Instruments & Bio-Inspired Technolog

An anthropomorphic deformable phantom of the vaginal wall and cavity

Brachytherapy is a common treatment in cervical, uterine and vaginal cancer management. The technique is characterised by rapid developments in the fields of medical imaging, dosimetry planning and personalised medical device design. To reduce unnecessary burden on patients, assessments and training of these technologies should preferable be done using high-fidelity physical phantoms. In this study, anthropomorphic deformable phantoms of the vaginal wall and cavity were developed for image-guided adaptive brachytherapy, in which vaginal wall biomechanics were mimicked. Phantoms were produced from both silicone and polyvinyl alcohol materials. Material characterisations were performed with uniaxial tensile tests, via which Young’s moduli and toughness were quantified. In addition, the contrast between adjacent phantom layers was quantified in magnetic resonance images. The results showed that stress-strain curves of the silicone phantoms were within the range of those found in healthy human vaginal wall tissues. Sample preconditioning had a large effect on Young’s moduli, which ranged between 2.13 and 6.94 MPa in silicone. Toughness was a more robust and accurate metric for biomechanical matching, and ranged between 0.23 and 0.28 ·106 J·m-3 as a result of preconditioning. The polyvinyl alcohol phantoms were not stiff or tough enough, with a Young’s modulus of 0.16 MPa and toughness of 0.02 ·106 J·m-3. All materials used could be clearly delineated in magnetic resonance images, although the MRI sequence did affect layer contrast. In conclusion, we developed anthropomorphic deformable phantoms that mimic vaginal wall tissue and are well visible in magnetic resonance images. These phantoms will be used to evaluate the properties and to optimise the development and use of personalised brachytherapy applicators.</p

Surgical Simulator Design and Development

With the introduction of minimally invasive surgery (MIS), it became necessary to develop training methods to learn skills outside the operating room. Several training simulators have become commercially available, but fundamental research into the requirements for effective and efficient training in MIS is still lacking. Three aspects of developing a training program are investigated here: what should be trained, how it should be trained, and how to assess the results of training. In addition, studies are presented that have investigated the role of force feedback in surgical simulators. Training should be adapted to the level of behavior: skill-based, rule-based, or knowledge-based. These levels can be used to design and structure a training program. Extra motivation for training can be created by assessment. During MIS, force feedback is reduced owing to friction in the laparoscopic instruments and within the trocar. The friction characteristics vary largely among instruments and trocars. When force feedback is incorporated into training, it should include the large variation in force feedback properties as well. Training different levels of behavior requires different training methods. Although force feedback is reduced during MIS, it is needed for tissue manipulation, and therefore force application should be trained as well

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

Hyperspectral imaging for the in vivo detection of ovarian cancer

Introduction For women diagnosed with advanced-stage epithelial ovarian cancer, complete cytoreductive surgery (CRS) is the most powerful independent parameter for prolonged survival. An intraoperative imaging technique to detect tumor deposits could help achieve complete CRS. Hyperspectral imaging (HSI) provides information on tissue composition, including tissue oxygenation, hemoglobin-, and tissue water and fat indices. In an earlier ex-vivo study it was shown that HSI can be used for ex-vivo tumor detection. Currently, we are evaluating whether HSI can be used in-vivo to distinguish tumor from healthy tissue.Methods HSI data of healthy and tumorous peritoneum, omentum, ovary, and mesentery were obtained in-vivo and preprocessed by image calibration and glare removal. The data were correlated to histopathology and used to train classifiers. The ability to delineate tumorous from healthy tissues was determined using leave-one-out cross-validation.Results A total of 18 images from 12 patients were included. In total 302.258 data points were extracted based on the knowledge of the surgeons and histopathological information. Our data shows that different organs that are affected by ovarian cancer yield different spectra. Additionally, we observe a difference in the spetra of tumor and non-tumor tissue.Conclusion/Implications HSI enables the classification of various tissue types, including tumor and non-tumor tissue. To improve classification outcomes, it is crucial to obtain more data and to make separate groups of healthy and tumorous tissues for each of these tissue types. HSI is a promising technique to differentiate between healthy tissue and ovarian cancer lesions and eventually help surgeons to achieve complete CRS

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