Question-based development of high-risk medical devices: A proposal for a structured design and review process.

INTRODUCTION: The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However, the requirements of clinical study design and developmental outcomes are only described in general terms due to the diversity of devices. METHODS: A structured approach to determining the requirements for the clinical development of high-risk medical devices is introduced, utilizing the question-based development framework, which is already used for pharmaceutical drug development. An example of a novel implantable device for haemodialysis demonstrates how to set up a relevant target product profile defining the device requirements and criteria. The framework can be used in the medical device design phase to define specific questions to be answered during the ensuing clinical development, based upon five general questions, specified by the question-based framework. RESULTS: The result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organizations will be guided to the optimal route, also to abandon projects destined for failure early on to minimize development risks. CONCLUSION: The framework could facilitate communication with funding agencies, regulators and clinicians, while highlighting remaining 'known unknowns' that require answering in the post-market phase after sufficient benefit is established relative to the risks.

Escape of surgical smoke particles, comparing conventional and valveless trocar systems.

BACKGROUND: During minimal access surgery, surgical smoke is produced which can potentially be inhaled by the surgical team, leading to several health risks. This smoke can escape from the abdominal cavity into the operating room due to trocar leakage. The trocars and insufflator that are used during surgery influence gas leakage. Therefore, this study compares particle escape from a valveless (Conmed AirSeal iFS), and a conventional (Karl Storz Endoflator) system. MATERIALS AND METHODS: Using an in vitro model, a conventional and a valveless trocar system were compared. A protocol that simulated various surgical phases was defined to assess the surgical conditions and particle leakage. Insufflation pressures and instrument diameters were varied as these are known to affect gas leakage. RESULTS: The conventional trocar leaked during two distinct phases. Removal of the obturator caused a sudden release of particles. During instrument insertion, an average of 211 (IQR 111) particles per second escaped when using the 5 mm diameter instrument. With the 10 mm instrument, 50 (IQR 13) particles per second were measured. With the conventional trocar, a higher abdominal pressure increased particle leakage. The valveless trocar demonstrated a continuously high particle release during all phases. After the obturator was removed, particle escape increased sharply. Particle escape decreased to 1276 (IQR 580) particles per second for the 5 mm instrument insertion, and 1084 (IQR 630) particles per second for 10 mm instrument insertion. With the valveless trocar system, a higher insufflation pressure lowered particle escape. CONCLUSIONS: This study shows that a valveless trocar system releases more particles into the operating room environment than a conventional trocar. During instrument insertion, the leakage through the valveless system is 6 to 20 times higher than the conventional system. With a valveless trocar, leakage decreases with increasing pressure. With both trocar types leakage depends on instrument diameter.

Force-based assessment of tissue handling skills in simulation training for robot-assisted surgery.

INTRODUCTION: Although robotic-assisted surgery is increasingly performed, objective assessment of technical skills is lacking. The aim of this study is to provide validity evidence for objective assessment of technical skills for robotic-assisted surgery. METHODS: An international multicenter study was conducted with participants from the academic hospitals Heidelberg University Hospital (Germany, Heidelberg) and the Amsterdam University Medical Centers (The Netherlands, Amsterdam). Trainees with distinctly different levels of robotic surgery experience were divided into three groups (novice, intermediate, expert) and enrolled in a training curriculum. Each trainee performed six trials of a standardized suturing task using the da Vinci Surgical System. Using the ForceSense system, five force-based parameters were analyzed, for objective assessment of tissue handling skills. Mann-Whitney U test and linear regression were used to analyze performance differences and the Wilcoxon signed-rank test to analyze skills progression. RESULTS: A total of 360 trials, performed by 60 participants, were analyzed. Significant differences between the novices, intermediates and experts were observed regarding the total completion time (41 s vs 29 s vs 22 s p = 0.003), mean non zero force (29 N vs 33 N vs 19 N p = 0.032), maximum impulse (40 Ns vs 31 Ns vs 20 Ns p = 0.001) and force volume (38 N3 vs 32 N3 vs 22 N3 p = 0.018). Furthermore, the experts showed better results in mean non-zero force (22 N vs 13 N p = 0.015), maximum impulse (24 Ns vs 17 Ns p = 0.043) and force volume (25 N3 vs 16 N3 p = 0.025) compared to the intermediates (p ≤ 0.05). Lastly, learning curve improvement was observed for the total task completion time, mean non-zero force, maximum impulse and force volume (p ≤ 0.05). CONCLUSION: Construct validity for force-based assessment of tissue handling skills in robot-assisted surgery is established. It is advised to incorporate objective assessment and feedback in robot-assisted surgery training programs to determine technical proficiency and, potentially, to prevent tissue trauma.

Crossover-effects in technical skills between laparoscopy and robot-assisted surgery.

INTRODUCTION: Robot-assisted surgery is often performed by experienced laparoscopic surgeons. However, this technique requires a different set of technical skills and surgeons are expected to alternate between these approaches. The aim of this study is to investigate the crossover effects when switching between laparoscopic and robot-assisted surgery. METHODS: An international multicentre crossover study was conducted. Trainees with distinctly different levels of experience were divided into three groups (novice, intermediate, expert). Each trainee performed six trials of a standardized suturing task using a laparoscopic box trainer and six trials using the da Vinci surgical robot. Both systems were equipped with the ForceSense system, measuring five force-based parameters for objective assessment of tissue handling skills. Statistical comparison was done between the sixth and seventh trial to identify transition effects. Unexpected changes in parameter outcomes after the seventh trial were further investigated. RESULTS: A total of 720 trials, performed by 60 participants, were analysed. The expert group increased their tissue handling forces with 46% (maximum impulse 11.5 N/s to 16.8 N/s, p = 0.05), when switching from robot-assisted surgery to laparoscopy. When switching from laparoscopy to robot-assisted surgery, intermediates and experts significantly decreased in motion efficiency (time (sec), resp. 68 vs. 100, p = 0.05, and 44 vs. 84, p = 0.05). Further investigation between the seventh and ninth trial showed that the intermediate group increased their force exertion with 78% (5.1 N vs. 9.1 N, p = 0.04), when switching to robot-assisted surgery. CONCLUSION: The crossover effects in technical skills between laparoscopic and robot-assisted surgery are highly depended on the prior experience with laparoscopic surgery. Where experts can alternate between approaches without impairment of technical skills, novices and intermediates should be aware of decay in efficiency of movement and tissue handling skills that could impact patient safety. Therefore, additional simulation training is advised to prevent from undesired events.

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.

Characterisation of trocar associated gas leaks during laparoscopic surgery.

BACKGROUND: During laparoscopy, the abdominal cavity is insufflated with carbon dioxide (CO2) that could become contaminated with viruses and surgical smoke. Medical staff is potentially exposed when this gas leaks into the operating room through the instruments and past trocar valves. No detailed studies currently exist that have quantified these leakage pathways. Therefore, the goal of this study was to quantify the gas leakages through trocars and instruments, during minimally invasive procedures. METHODS: A model of the surgical environment was created, consisting of a rigid container with an interface for airtight clamping of laparoscopic equipment such as trocars and surgical instruments. The model was insufflated to 15 mm Hg using a pressure generator and a pneumotachograph measured the equipment gas leak. A protocol of several use cases was designed to simulate the motions and forces the surgeon exerts on the trocar during surgery. RESULTS: Twenty-three individual trocars and twenty-six laparoscopic instruments were measured for leakage under the different conditions of the protocol. Trocar leakages varied between 0 L/min and more than 30 L/min, the instruments revealed a range of leakages between 0 L/min and 5.5 L/min. The results showed that leakage performance varied widely between trocars and instruments and that the performance and location of the valves influenced trocar leakage. CONCLUSIONS: We propose trocar redesigns to overcome specific causes of gas leaks. Moreover, an international testing standard for CO2 leakage for all new trocars and instruments is needed so surgical teams can avoid this potential health hazard when selecting new equipment.

Using Acoustic Vibrations as a Method for Implant Insertion Assessment in Total Hip Arthroplasty.

The success of total hip arthroplasty depends on the experience of the surgeon, and one of the ways the surgeon currently determines the final implant insertion depth is to listen to the change in audible pitch of the hammering sound. We investigated the use of vibration emissions as a novel method for insertion quality assessment. A non-invasive contact microphone-based measurement system for insertion depth estimation, fixation and fracture detection was developed using a simplified in vitro bone/implant (n = 5). A total of 2583 audio recordings were analyzed in vitro to obtain energy spectral density functions. Out of the four main resonant peaks under in vitro conditions, broach insertion depth statistically correlates to increasing 3rd and 4th peak frequencies. Degree of fixation was also observed as higher goodness of fit (0.26-0.78 vs. 0.12-0.51 between two broach sizes, the latter undersized). Finally, however, the moment of fracture could not be predicted. A cadaveric in situ pilot study suggests comparable resonant frequencies in the same order of magnitudes with the bone model. Further understanding of the signal patterns are needed for an early warning system diagnostic system for imminent fractures, bone damage, improving accuracy and quality of future procedures.

Haptic exploration improves performance of a laparoscopic training task.

BACKGROUND: Laparoscopy has reduced tactile and visual feedback compared to open surgery. There is increasing evidence that visual and haptic information converge to form a more robust mental representation of an object. We investigated whether tactile exploration of an object prior to executing a laparoscopic action on it improves performance. METHODS: A prospective cohort study with 20 medical students randomized in two different groups was conducted. A silicone ileocecal model, on which a laparoscopic action had to be performed, was used inside an outside a ForceSense box trainer. During the pre-test, students either did a combined manual and visual exploration or only visual exploration of the caecum model. To track performance during the trials of the study we used force, motion and time parameters as representatives of technical skills development. The final trial data were used for statistical comparison between groups. RESULTS: All included time and motion parameters did not show any clear differences between groups. However, the force parameters Mean force non-zero (p = 004), Maximal force (p = 0.01) Maximal impulse (p = 0.02), Force volume (p = 0.02) and SD force (p = 0.01) showed significant lower values in favour of the tactile exploration group for the final trials. CONCLUSIONS: By adding haptic sensation to the existing visual information during training of laparoscopic tasks on life-like models, tissue manipulation skills improve during training.

Measuring Forces in Suture Techniques for Wound Closure.

BACKGROUND: The use of sutures remains the first choice for wound closure. However, incorrect use of a suture technique can lead to impaired healing. Many techniques are described for high-tension wounds, but not much is known about their mechanical properties. Complications of excessive tension include dehiscence, infection, and ischemic necrosis and could be prevented. This study aimed to compare forces in five techniques (single, horizontal mattress, vertical mattress, pulley, and modified pulley suture) in a standardized wound tension model. MATERIALS AND METHODS: A standardized neoprene wound model was developed on the ForceTRAP system (MediShield B.V., Delft, The Netherlands) to mimic a 5 Newton (N) wound. Five different suture techniques were each repeated 10 times by a student, resident dermatology, and dermsurgeon. The pulling force of the suture's first throw was measured with the Hook-in-Force sensor (Technical University Delft, The Netherlands). Changes in wound tension were measured by the ForceTRAP system. The ForceTRAP is a platform measuring forces from 0 to 20 N in three dimensions with an accuracy of 0.1 N. The Hook-in-Force is a force sensor measuring 0-15 N with an accuracy of 0.5 N. Maximum and mean forces were calculated for each suture technique and operator. RESULTS: Mean maximum pulling force: 5.69 N (standard deviation [SD], 0.88) single, 7.25 N (SD, 1.33) vertical mattress, 8.11 N (SD, 1.00) horizontal mattress, 3.46 N (SD, 0.61) pulley, and 4.52 N (SD, 0.67) modified pulley suture. The mean force increase on the skin (substitute) ranged between 0.80 N (pulley) and 0.96 N (vertical mattress). CONCLUSIONS: The pulley suture requires less pulling force compared with other techniques. The mechanical properties of sutures should be taken in consideration when choosing a technique to close wounds.

A new modular mechanism that allows full detachability and cleaning of steerable laparoscopic instruments.

BACKGROUND: Ever since the introduction of laparoscopic surgery, researchers have been trying to add steerability to instruments to allow the surgeon to operate with better reachability and less tissue interaction force. Traditional solutions to introduce this often use a combination of springs, cables, pulleys, and guiding structures, resulting in instruments that cannot be properly cleaned and thus are very costly to manufacture and maintain. The aim of the study is to develop a novel affordable, sustainable, cableless, and fully steerable laparoscopic grasper, and to test its ease of assembly, disassembly, and use. METHODS: A set of requirements was defined to ensure that the instrument can be handled efficiently at the sterilization unit and in the operating room. Based on these, a multisteerable, cableless 5 mm laparoscopic instrument that operates based on shaft rotations was developed. To test its assembly and disassembly, ten participants were asked to fully dismantle the instrument and reassemble it a total of 60 times. In addition, ten medical students were asked to use the grasper in the ForceSense box-trainer system on a newly developed 3D pick-and-place task, to determine the control effort based on learning curves of steering errors, task time, instrument path length, and maximum tissue interaction force. RESULTS: All important design requirements were met. The recorded data indicates that ten engineering students were able to fully dismantle and reassemble the instrument shaft in 12 s (SD7) and 65 s (SD43) seconds at the sixth attempt. The learning-curve data indicates that three attempts were needed before the ten medical students started to use all steering functions. At the sixth attempt, on average only 1.25 (SD0.7) steering errors were made. The steepest slope in the learning curves for steering errors, path length, and task time was experienced during the first three attempts. In respect of the interaction force, no learning effect was observed. CONCLUSION: The multi-DOF (degree of freedom) cableless grasper can be assembled and disassembled for cleaning and sterilization within an acceptable time frame. The handle interface proved to be intuitive enough for novices to conduct a complex 3D pick-and-place task in a training setting.

Force-based learning curve tracking in fundamental laparoscopic skills training.

BACKGROUND: Within minimally invasive surgery (MIS), structural implementation of courses and structured assessment of skills are challenged by availability of trainers, time, and money. We aimed to establish and validate an objective measurement tool for preclinical skills acquisition in a basic laparoscopic at-home training program. METHODS: A mobile laparoscopic simulator was equipped with a state-of-the-art force, motion, and time tracking system (ForceSense, MediShield B.V., Delft, the Netherlands). These performance parameters respectively representing tissue manipulation and instrument handling were continuously tracked during every trial. Proficiency levels were set by clinical experts for six different training tasks. Resident's acquisition and development of fundamental skills were evaluated by comparing pre- and post-course assessment measurements and OSATS forms. A questionnaire was distributed to determine face and content validity. RESULTS: Out of 1842 captured attempts by novices, 1594 successful trials were evaluated. A decrease in maximum exerted absolute force was shown in comparison of four training tasks (p ≤ 0.023). Three of the six comparisons also showed lower mean forces during tissue manipulation (p ≤ 0.024). Lower instrument handling outcomes (i.e., time and motion parameters) were observed in five tasks (resp. (p ≤ 0.019) and (p ≤ 0.025)). Simultaneously, all OSATS scores increased (p ≤ 0.028). Proficiency levels for all tasks can be reached in 2 weeks of at home training. CONCLUSIONS: Monitoring force, motion, and time parameters during training showed to be effective in determining acquisition and development of basic laparoscopic tissue manipulation and instrument handling skills. Therefore, we were able to gain insight into the amount of training needed to reach certain levels of competence. Skills improved after sufficient amount of training at home. Questionnaire outcomes indicated that skills and self-confidence improved and that this training should therefore be part of the regular residency training program.

Improving training of laparoscopic tissue manipulation skills using various visual force feedback types.

BACKGROUND: Visual force feedback allows trainees to learn laparoscopic tissue manipulation skills. The aim of this experimental study was to find the most efficient visual force feedback method to acquire these skills. Retention and transfer validity to an untrained task were assessed. METHODS: Medical students without prior experience in laparoscopy were randomized in three groups: Constant Force Feedback (CFF) (N = 17), Bandwidth Force Feedback (BFF) (N = 16) and Fade-in Force Feedback (N = 18). All participants performed a pretest, training, post-test and follow-up test. The study involved two dissimilar tissue manipulation tasks, one for training and one to assess transferability. Participants performed six trials of the training task. A force platform was used to record several force parameters. RESULTS: A paired-sample t test showed overall lower force parameter outcomes in the post-test compared to the pretest (p < .001). A week later, the force parameter outcomes were still significantly lower than found in the pretest (p < .005). Participants also performed the transfer task in the post-test (p < .02) and follow-up (p < .05) test with lower force parameter outcomes compared to the pretest. A one-way MANOVA indicated that in the post-test the CFF group applied 50 % less Mean Absolute Nonzero Force (p = .005) than the BFF group. CONCLUSION: All visual force feedback methods showed to be effective in decreasing tissue manipulation force as no major differences were found between groups in the post and follow-up trials. The BFF method is preferred for it respects individual progress and minimizes distraction.

Navigation forces during wrist arthroscopy: assessment of expert levels.

PURPOSE: To facilitate effective and efficient training in skills laboratory, objective metrics can be used. Forces exerted on the tissues can be a measure of safe tissue manipulation. To provide feedback during training, expert threshold levels need to be determined. The purpose of this study was to define the magnitude and the direction of navigation forces used during arthroscopic inspection of the wrist. METHODS: We developed a set-up to mount a cadaver wrist to a 3D force platform that allowed measurement of the forces exerted on the wrist. Six experts in wrist arthroscopy performed two tasks: (1) Introduction of the camera and visualization of the hook. (2) Navigation through the wrist with visualization of five anatomic structures. The magnitude (Fabs) and direction of force were recorded, with the direction defined as α being the angle in the vertical plane and ß being the angle in the horizontal plane. The 10th-90th percentile of the data were used to set threshold levels for training. RESULTS: The results show distinct force patterns for each of the anatomic landmarks. Median Fabs of the navigation task is 3.8 N (1.8-7.3), α is 3.60 (-54-44) and ß is 260 (0-72). CONCLUSION: Unique expert data on navigation forces during wrist arthroscopy were determined. The defined maximum allowable navigation force of 7.3 N (90th percentile) can be used in providing feedback on performance during skills training. The clinical value is that this study contributes to objective assessment of skills levels.

Learning from visual force feedback in box trainers: tissue manipulation in laparoscopic surgery.

BACKGROUND: Currently, task time and errors are often used as performance parameters in laparoscopic training. Training with the focus on task time improvement alone results in fast, but possibly less controlled, instrument movements and therefore suboptimal tissue handling skills. METHODS: Twenty-five medical students were randomly assigned in two groups. Both groups performed a tissue manipulation task six times. During this training session, the time feedback group (n = 13) received real-time visual feedback of the task time. The force feedback group (n = 12) received real-time visual feedback of the tissue manipulation force. After the training sessions, participants in both groups performed an entirely different task without visual feedback. Task time, force, and motion parameters of this posttest were used to compare the technical skills of the medical students. RESULTS: The training data of the group that received force feedback showed a learning curve for the mean and max absolute force, max force area, force volume, task time, and path length of both instruments. The data from the group that received time feedback showed a learning curve for the max force, task time, and path length of both instruments. In the posttest, the parameters of mean absolute force (p = 0.039), max force (p = 0.041), and force volume (p = 0.009) showed a significant difference in favor of the group that received force feedback. CONCLUSIONS: The learning curves and the posttest indicate that training with visual force feedback improves tissue handling skills with no negative effect on the task time and instrument motions. Conventional laparoscopic training with visual time feedback improves instrument motion and task time, but it does not improve tissue manipulation skills.

Design and evaluation of a smart passive dynamic arm support for robotic-assisted laparoscopic surgery.

Surgeons performing robotic-assisted laparoscopic surgery experience physical stress and overuse of shoulder muscles due to sub-optimal arm support during surgery. The objective is to present a novel design and prototype of a dynamic arm support for robotic laparoscopic surgery to evaluate its ergonomics and performance on the AdLap-VR simulation training device. The prototype was designed using the mechanical engineering design process: Technical requirements, concept creation, concept selection, 3D-design and built of the prototype. A crossover study was performed on a marble sorting task on the AdLap-VR. The first group performed four trials without the arm support, followed by four trials with the arm support, and the other group executed the sequence vice versa. The performance parameters used were time to complete (s), path length (mm), and the number of collisions. Afterward, the participants filled out a questionnaire on the ergonomic experience regarding both situations. 20 students executed 160 performed trials on the AdLap-VR Significant decreases in the subjective comfort parameters mental demand, physical demand, effort and frustration were observed as a result of introducing the novel arm support. Significant decreases in the objective performance parameters path length and the number of collisions were also observed during the tests. The newly developed dynamic arm support was found to improve comfort and enhance performance through increased stability on the robotic surgery skills simulator AdLap-VR.

"O.R. GOES GREEN": a first step toward reducing our carbon footprint in the operating room and hospital.

Hospitals in Europe produce approximately 6 million tons of medical waste annually, about one-third of this originating in operating rooms. Most of it is solid waste, which can be recycled if bodily fluids do not contaminate it. Only 2-3% of hospital waste must be disposed of as infectious waste, and this is much lower than the 50-70% of garbage in the biohazard waste stream. In June 2021, at the main operating room of the Department of General Surgery of the University of Turin, we began a separate collection program for materials consisting of plastic, paper, TNT (material not contaminated by bodily fluids), and biohazardous waste. We calculated the number of boxes and the weight of special waste disposed produced every month in one operating room for 18 months. The monthly number of Sanibox and the monthly weight of biohazardous waste decreased during the observation period. The reduction trend was not constant but showed variations during the 18 months. Direct proportionality between number of low-complexity procedures and production of biohazardous waste was found (p = 0.050). We observed an optimization in the collection and filling of plastic, paper and TNT boxes separated and sent for recycling. One of the barriers to recycling hospital waste, and surgical waste in particular, is the failure to separate infectious waste from clean waste. A careful separate collection of waste in the operating room is the first step in reducing environmental pollution and management costs for the disposal of hospital waste.

Design and In Vitro Validation of an Orthopaedic Drill Guide for Femoral Stem Revision in Total Hip Arthroplasty.

OBJECTIVE: Cemented total hip arthroplasty (THA) demonstrates superior survival rates compared to uncemented procedures. Nevertheless, most younger patients opt for uncemented THA, as removing well-fixed bone cement in the femur during revisions is complex, particularly the distal cement plug. This removal procedure often increases the risk of femoral fracture or perforation, haemorrhage and weakening bone due to poor drill control and positioning. Aim of this study was to design a novel drill guide to improve drill positioning. METHODS AND PROCEDURES: A novel orthopaedic drill guide was developed, featuring a compliant centralizer activated by a drill guide actuator. Bone models were prepared to assess centralizing performance. Three conditions were tested: drilling without guidance, guided drilling with centralizer activation held, and guided drilling with centralizer activation released. Deviations from the bone centre were measured at the entry and exit point of the drill. RESULTS: In the centralizing performance test, the drill guide significantly reduced drill hole deviations in both entry and exit points compared to the control ([Formula: see text]). The absolute deviation on the exit side of the cement plug was 10.59mm (SD 1.56) for the 'No drill guide' condition, 3.02mm (SD 2.09) for 'Drill guide - hold' and 2.12mm (SD 1.71) for 'Drill guide - release'. The compliant drill guide centralizer significantly lowered the risk of cortical bone perforation during intramedullary canal drilling in the bone models due to better control of the cement drill position. Clinical and Translational Impact Statement: The drill guide potentially reduces perioperative risks in cemented femoral stem revision. Future research should identify optimal scenarios for its application.

An Implantable Magnetic Drive Mechanism for Non-Invasive Arteriovenous Conduit Blood Flow Control.

OBJECTIVE: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. METHODS: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. RESULTS: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9 ± 4.2 N, 46.7 ± 1.9 N, 25.6 ± 0.7 N, 13.5 ± 0.6 N and 6.3 ± 0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm. CONCLUSION: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects. SIGNIFICANCE: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.

The influence of instrument configuration on tissue handling force in laparoscopy.

In single-access surgery, instruments enter the abdominal cavity through only 1 incision, the position of the instruments relative to each other is different compared with that in conventional laparoscopy. Changes in instrument configuration may increase task complexity and therefore affect tissue handling skills. The aim of this study is to determine if a relation exists between instrument configuration and tissue interaction force. A study was performed to investigate the differences in manipulation force between a single-port (SP) and 2-port (TP) instrument configuration in a standard box trainer. A force platform was placed under a tissue manipulation task in a box trainer and used to measure the pulling forces and trial time. A total of 28 medical students with no previous experience in laparoscopic surgery were divided into 2 equal groups. Group 1 trained the task 6 times with the TP configuration and subsequently performed 6 trials with the SP configuration. Group 2 used the configurations in the opposite order. For both groups, the learning curves of the maximum force and task time were compared. Time and maximum pulling forces were significantly different between the 2 instrument configurations. In both groups, the participants used significantly more force in the SP configuration than in the TP configuration. The force data indicate that the increased complexity in instrument handling with straight instruments in a SP configuration increases the tissue manipulation force. Furthermore, the tissue handling skills of novices who mastered the task with the TP configuration decreased after switching to the SP configuration.