Negative Pressure Wound Therapy (NPWT) is a treatment that promotes healing of chronic wounds. Despite high prevalence of chronic wounds in Low- and Middle-Income Countries (LMICs), NPWT devices are not available nor affordable. This study aims to improve chronic wound care in LMICs by presenting the Wound Care (WOCA) system, designed for building, testing and use in LMICs. Design requirements were formulated using input from literature, ISO standards, and wound care experts. The WOCA design was developed to provide safe, portable, user-friendly and affordable NPWT to patients in LMICs. The design features an adjustable operating pressure ranging from −75 to −125 mmHg, a battery for portability, a 300 ml canister, overflow protection, and system state alarms. An Arduino controls the pressure and monitors the system state. Three prototypes were developed and built in Nepal, and their performance was evaluated. Pressure control was 125 ± 10 % mmHg, internal leakage was 7.5 ± 4.3 mmHg/min, reserve capacity was 189 ± 16.9 ml/min, and overflow protection and alarm systems were effectively working. Prototype cost was approximately 280 USD. The WOCA demonstrates to be a locally producible NPWT device that can safely generate a stable vacuum. Future research will include clinical trials situated in LMICs.

@en

Since the introduction of robot-assisted laparoscopic surgery, efforts have been made to incorporate force sensing technologies to monitor critical components and to provide force feedback. The advanced laparoscopic robotic system (AdLap RS) is a robotic platform that aims to make robot technology more sustainable through the use of the fully reusable shaft-actuated tip-articulating (SATA) instruments. The SATA instrument driver features electronics and sensors exposed to the sterile environment, which complicate the sterilisation process. The aim of this study was to develop and validate smart sensing in stepper motors using the back electromotive force in a newly developed Smart SATA Driver (SSD), eliminating the need for sensors in the sterile environment. Methods: The stepper drivers were equipped with TMC2209 ICs featuring StallGuard technology to measure back EMF. The tip was actuated up until a set StallGuard threshold value was reached, at which the resulting tip force was measured. This cycle was repeated ten times for a range of threshold levels. A regression analysis with a power series model was used to determine the quality of the fit. Results: The SSD is capable of exerting tip forces between 2.4 and 8.2 N. The back EMF force test demonstrated a strong correlation between obtained StallGuard values and measured tip forces. The regression analysis showed an R-squared of 0.95 and a root Mean squared error of 0.4 N. Discussion: The back EMF force test shows promise for force feedback, but its accuracy limits real-time use due to back EMF fluctuations. Future improvements in motor stability and refining the back EMF model are needed to enable real-time feedback. Conclusion: The strong correlation during the back EMF force test shows its potential as a low-budget method for detecting motor stalls and estimating tool–tissue forces without the need for sensors in laparoscopic instruments.@en

This systematic review explores machine learning (ML) applications in surgical motion analysis using non-optical motion tracking systems (NOMTS), alone or with optical methods. It investigates objectives, experimental designs, model effectiveness, and future research directions. From 3632 records, 84 studies were included, with Artificial Neural Networks (38%) and Support Vector Machines (11%) being the most common ML models. Skill assessment was the primary objective (38%). NOMTS used included internal device kinematics (56%), electromagnetic (17%), inertial (15%), mechanical (11%), and electromyography (1%) sensors. Surgical settings were robotic (60%), laparoscopic (18%), open (16%), and others (6%). Procedures focused on bench-top tasks (67%), clinical models (17%), clinical simulations (9%), and non-clinical simulations (7%). Over 90% accuracy was achieved in 36% of studies. Literature shows NOMTS and ML can enhance surgical precision, assessment, and training. Future research should advance ML in surgical environments, ensure model interpretability and reproducibility, and use larger datasets for accurate evaluation.

@en

Endovascular intervention is a minimally invasive method for treating cardiovascular diseases. Although fluoroscopy, known for real-time catheter visualization, is commonly used, it exposes patients and physicians to ionizing radiation and lacks depth perception due to its 2D nature. To address these limitations, a study was conducted using teleoperation and 3D visualization techniques. This in-vitro study involved the use of a robotic catheter system and aimed to evaluate user performance through both subjective and objective measures. The focus was on determining the most effective modes of interaction. Three interactive modes for guiding robotic catheters were compared in the study: 1) Mode GM, using a gamepad for control and a standard 2D monitor for visual feedback; 2) Mode GH, with a gamepad for control and HoloLens providing 3D visualization; and 3) Mode HH, where HoloLens serves as both control input and visualization device. Mode GH outperformed other modalities in subjective metrics, except for mental demand. It exhibited a median tracking error of 4.72 mm, a median targeting error of 1.01 mm, a median duration of 82.34 s, and a median natural logarithm of dimensionless squared jerk of 40.38 in the in-vitro study. Mode GH showed 8.5%, 4.7%, 6.5%, and 3.9% improvements over Mode GM and 1.5%, 33.6%, 34.9%, and 8.1% over Mode HH for tracking error, targeting error, duration, and dimensionless squared jerk, respectively. To sum up, the user study emphasizes the potential benefits of employing HoloLens for enhanced 3D visualization in catheterization. The user study also illustrates the advantages of using a gamepad for catheter teleoperation, including user-friendliness and passive haptic feedback, compared to HoloLens. To further gauge the potential of using a more traditional joystick as a control input device, an additional study utilizing the Haption Virtuose robot was conducted. It reveals the potential for achieving smoother trajectories, with a 38.9% reduction in total path length compared to a gamepad, potentially due to its larger range of motion and single-handed control.

@en

Objective: Navigation through tortuous and deformable vessels using catheters with limited steering capability underscores the need for reliable path planning. State-of-the-art path planners do not fully account for the deformable nature of the environment. Methods: This work proposes a robust path planner via a learning from demonstrations method, named Curriculum Generative Adversarial Imitation Learning (C-GAIL). This path planning framework takes into account the interaction between steerable catheters and vessel walls and the deformable property of vessels. Results: In-silico comparative experiments show that the proposed network achieves a 38% higher success rate in static environments and 17% higher in dynamic environments compared to a state-of-the-art approach based on GAIL. In-vitro validation experiments indicate that the path generated by the proposed C-GAIL path planner achieves a targeting error of 1.26±0.55mm and a tracking error of 5.18±3.48mm. These results represent improvements of 41% and 40% over the conventional centerline-following technique for targeting error and tracking error, respectively. Conclusion: The proposed C-GAIL path planner outperforms the state-of-the-art GAIL approach. The in-vitro validation experiments demonstrate that the path generated by the proposed C-GAIL path planner aligns better with the actual steering capability of the pneumatic artificial muscle-driven catheter utilized in this study. Therefore, the proposed approach can provide enhanced support to the user in navigating the catheter towards the target with greater accuracy, effectively meeting clinical accuracy requirements. Significance: The proposed path planning framework exhibits superior performance in managing uncertainty associated with vessel deformation, thereby resulting in lower tracking errors.

@en

BACKGROUND AND PURPOSE: Although MRI-based image guided adaptive brachytherapy (IGABT) for locally advanced cervical cancer (LACC) has resulted in favorable outcomes, it can be logistically complex and time consuming compared to 2D image-based brachytherapy, and both physically and emotionally intensive for patients. This prospective study aims to perform time-action and patient experience analyses during IGABT to guide further improvements. MATERIALS AND METHODS: LACC patients treated with IGABT were included for the time-action (56 patients) and patient experience (29 patients) analyses. Times per treatment step were reported on a standardized form. For the patient experience analysis, a baseline health status was established with the EQ-5D-5L questionnaire and the perceived pain, anxiety and duration for each treatment step were assessed with the NRS-11. RESULTS: The median total procedure time from arrival until discharge was 530 (IQR: 480–565) minutes. Treatment planning (delineation, reconstruction, optimization) required the most time and took 175 (IQR: 145–195) minutes. Highest perceived pain was reported during applicator removal and treatment planning, anxiety during applicator removal, and duration during image acquisition and treatment planning. Perceived pain, anxiety and duration were correlated. Higher pre-treatment pain and anxiety scores were associated with higher perceived pain, anxiety and duration. CONCLUSION: This study highlights the complexity, duration and impact on patient experience of the current IGABT workflow. Patient reported pre-treatment pain and anxiety can help identify patients that may benefit from additional support. Research and implementation of measures aiming at shortening the overall procedure duration, which may include logistical, staffing and technological aspects, should be prioritized.

@en

Background: The steep radiation dose gradients in cervical cancer brachytherapy (BT) necessitate a thorough understanding of the behavior of afterloader source cables or needles in the curved channels of (patient-tailored) applicators. Purpose: The purpose of this study is to develop and validate computer models to simulate: (1) BT source positions, and (2) insertion forces of needles in curved applicator channels. The methodology presented can be used to improve the knowledge of instrument behavior in current applicators and aid the development of novel (3D-printed) BT applicators. Methods: For the computer models, BT instruments were discretized in finite elements. Simulations were performed in SPACAR by formulating nodal contact force and motion input models and specifying the instruments’ kinematic and dynamic properties. To evaluate the source cable model, simulated source paths in ring applicators were compared with manufacturer-measured source paths. The impact of discrepancies on the dosimetry was estimated for standard plans. To validate needle models, simulated needle insertion forces in curved channels with varying curvature, torsion, and clearance, were compared with force measurements in dedicated 3D-printed templates. Results: Comparison of simulated with manufacturer-measured source positions showed 0.5–1.2 mm median and <2.0 mm maximum differences, in all but one applicator geometry. The resulting maximum relative dose differences at the lateral surface and at 5 mm depth were 5.5% and 4.7%, respectively. Simulated insertion forces for BT needles in curved channels accurately resembled the forces experimentally obtained by including experimental uncertainties in the simulation. Conclusion: The models developed can accurately predict source positions and insertion forces in BT applicators. Insights from these models can aid novel applicator design with improved motion and force transmission of BT instruments, and contribute to the estimation of overall treatment precision. The methodology presented can be extended to study other applicator geometries, flexible instruments, and afterloading systems.

@en

Background: Compliance with the recommended 30 s drying time of alcohol-based hand rub (ABHR) is often suboptimal. To increase hand hygiene compliance at a neonatal intensive care unit (NICU), we installed an Incubator Traffic Light (ITL) system which shows ‘green light’ to open incubator doors after the recommended drying time. Aim: To measure the impact of this visual feedback system on NICU healthcare professionals' compliance with the recommended ABHR drying time. Methods: Ten traffic light systems were installed on incubators at a NICU, five of which provided visual feedback, and five, serving as a control group, did not provide visual feedback. During a two-month period, the systems measured drying time between the moment of dispensing ABHR and opening the incubator's doors. The drying times of the incubators were compared with and without feedback. Findings: Of the 6422 recorded hand hygiene events, 658 were valid for data analysis. Compliance with correct drying time reached 75% (N = 397/526) for incubators equipped with visual feedback versus 36% (N = 48/132; P < 0.0001) for incubators lacking this feature. Conclusion: The ITL improves compliance with the recommended 30 s ABHR drying time in a NICU setting.

@en

Introduction: Most robotic instruments and their drives still risk residual contamination due to cleaning complexities, rendering them limited reusable, and tend to have larger instruments than the 5mm laparoscopic standard. The novel steerable laparoscopic SATA-LRS uses modularity for cleanability and exchangeability. The SATA-Drive: a robotic driver designed for the actuation of a 3mm scaled version of the SATA-LRS is presented. Methods: A modular, expandable gear mechanism was designed to efficiently rotate and translate the instrument shafts. The 3mm SATA-LRS is controlled as proof. An user-experiment is conducted to test the (de)coupling of the instrument to and from the drive. Results: A video shows the SATA-Driver successfully articulating, rotating and grasping the end-effector. End-effector dis- and reassembly is possible in 36 (13 SD) seconds, while complete instrument coupling requires 28(8 SD) seconds and de-coupling requires 16 (7 SD) seconds. Discussion: A non-surgical robot arm, mounted with the SATA-drive has effectively been transformed into a system similar to robot assisted laparoscopy. The modularity of the drive's segmented build can easily be adapted and could benefit the adoption of future instruments. The SATA-LRS's cleanability features and its end-effector changes without disassembly are expected to benefit medical robotics. The 3mm SATA-LRS shows the instrument's potential for mini-laparoscopy.

@en

It is estimated that in Africa 30,000-130,000 new cases arise annually and a total of 3 million women suffer from untreated vesicovaginal fistulas (VVFs) in Low- and Middle-Income Countries (LMICs) worldwide. A VVF is an abnormal communication between the bladder and vagina that can result in urine leakage through the vagina. This does not only lead to physical but also psychological problems. In LIMCs, the most common cause of a VVF is obstructed labour. Early childbearing (before full pelvic growth is achieved), poor socioeconomic status, low literacy rate, malnourishment, inadequately developed infrastructure for health care for pregnant women and lack of access to emergency obstetric services are factors that impact the high rate of cases in LIMCs. Some of the consequences are stigmatization and social isolation, because obstructed labour is often seen as a punishment from God and patients are abandoned by their families because of the smell of urine. [...]@en

Introduction: In clinical practice, fetal heart rate monitoring is performed intermittently using Doppler ultrasound, typically for 30 minutes. In case of a non-reassuring heart rate pattern, monitoring is usually prolonged. Noninvasive fetal electrocardiography may be more suitable for prolonged monitoring due to improved patient comfort and signal quality. This study evaluates the performance and patient experience of four noninvasive electrocardiography devices to assess candidate devices for prolonged noninvasive fetal heart rate monitoring. Material and methods: Non-critically sick women with a singleton pregnancy from 24 weeks of gestation were eligible for inclusion. Fetal heart rate monitoring was performed during standard care with a Doppler ultrasound device (Philips Avalon-FM30) alone or with this Doppler ultrasound device simultaneously with one of four noninvasive electrocardiography devices (Nemo Fetal Monitoring System, Philips Avalon-Beltless, Demcon Dipha-16 and Dräger Infinity-M300). Performance was evaluated by: success rate, positive percent agreement, bias, 95% limits of agreement, regression line, root mean square error and visual agreement using FIGO guidelines. Patient experience was captured using a self-made questionnaire. Results: A total of 10 women were included per device. For fetal heart rate, Nemo performed best (success rate: 99.4%, positive percent agreement: 94.2%, root mean square error 5.1 BPM, bias: 0.5 BPM, 95% limits of agreement: −9.7 – 10.7 BPM, regression line: y = −0.1x + 11.1) and the cardiotocography tracings obtained simultaneously by Nemo and Avalon-FM30 received the same FIGO classification. Comparable results were found with the Avalon-Beltless from 36 weeks of gestation, whereas the Dipha-16 and Infinity-M300 performed significantly worse. The Avalon-Beltless, Nemo and Infinity-M300 closely matched the performance of the Avalon-FM30 for maternal heart rate, whereas the performance of the Dipha-16 deviated more. Patient experience scores were higher for the noninvasive electrocardiography devices. Conclusions: Both Nemo and Avalon-Beltless are suitable devices for (prolonged) noninvasive fetal heart rate monitoring, taking their intended use into account. But outside its intended use limit of 36 weeks’ gestation, the Avalon-Beltless performs less well, comparable to the Dipha-16 and Infinity-M300, making them currently unsuitable for (prolonged) noninvasive fetal heart rate monitoring. Noninvasive electrocardiography devices appear to be preferred due to greater comfort and mobility.

@en

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 (p < 0.05). 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.

@en

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.

@en

Objectives
To study the methodology and results of studies assessing the relationship between fetal heart rate and specified neonatal outcomes including, heart rate, infection, necrotizing enterocolitis, intraventricular hemorrhage, hypoxic-ischemic encephalopathy, and seizure.

Methods
Embase, Medline ALL, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, and CINAHL were searched from inception to October 5, 2023.

Results
Forty-two studies were included, encompassing 57,232 cases that underwent fetal monitoring and were evaluated for neonatal outcome. Heterogeneity was observed in the timing and duration of fetal heart rate assessment, classification guidelines used, number of assessors, and definition and timing of neonatal outcome assessment. Nonreassuring fetal heart rate was linked to lower neonatal heart rate variability. A significant increase in abnormal fetal heart rate patterns were reported in neonates with hypoxic-ischemic encephalopathy, but the predictive ability was found to be limited. Conflicting results were reported regarding sepsis, seizure and intraventricular hemorrhage. No association was found between necrotizing enterocolitis rate and fetal heart rate.

Conclusions
There is great heterogeneity in the methodology used in studies evaluating the association between fetal heart rate and aforementioned neonatal outcomes. Hypoxic-ischemic encephalopathy was associated with increased abnormal fetal heart rate patterns, although the predictive ability was low. Further research on developing and evaluating an automated early warning system that integrates computerized cardiotocography with a perinatal health parameter database to provide objective alerts for patients at-risk is recommended.
@en

Collision feedback about instrument and environment interaction is often lacking in robotic surgery training devices. The PoLaRS virtual reality simulator is a newly developed desk trainer that overcomes drawbacks of existing robot trainers for advanced laparoscopy. This study aimed to assess the effect of haptic and visual feedback during training on the performance of a robotic surgical task. Robotic surgery-naïve participants were randomized and equally divided into two training groups: Haptic and Visual Feedback (HVF) and No Haptic and Visual Feedback. Participants performed two basic virtual reality training tasks on the PoLaRS system as a pre- and post-test. The measurement parameters Time, Tip-to-tip distance, Path length Left/Right and Collisions Left/Right were used to analyze the learning curves and statistically compare the pre- and post-tests performances. In total, 198 trials performed by 22 participants were included. The visual and haptic feedback did not negatively influence the time to complete the tasks. Although no improvement in skill was observed between pre- and post-tests, the mean rank of the number of collisions of the right grasper (dominant hand) was significantly lower in the HVF feedback group during the second post-test (Mean Rank = 8.73 versus Mean Rank = 14.27, U = 30.00, p = 0.045). Haptic and visual feedback during the training on the PoLaRS system resulted in fewer instrument collisions. These results warrant the introduction of haptic feedback in subjects with no experience in robotic surgery. The PoLaRS system can be utilized to remotely optimize instrument handling before commencing robotic surgery in the operating room.

@en

While articulated surgical instruments have enabled the proliferation of minimally invasive interventions, procedures such as laparo-endoscopic single-site surgery are waning in popularity. One potential reason for this decline is a lack of sufficiently dexterous instruments. Although multi-steerable instruments exist, these are often complex and therefore expensive assemblies. Even when 3D printing was used to simplify the design of these instruments, the requirement for high-performance 3D printers limited the reduction in manufacturing costs. To tackle this issue, we propose six guidelines for converting a 3D printed compliant medical instrument from printing on a Digital Light Processing (DLP) printer to a Fused Filament Fabrication (FFF) printer. These guidelines provide a framework to manage and compensate for differences in the two processes to achieve comparable results at a reduced cost. The proposed guidelines were evaluated by assembling a FFF 3D printed prototype that shows equivalent performance to its DLP 3D printed counterpart.

@en

Minimally Invasive Procedures (MIPs) emerged as an alternative to more invasive surgical approaches, offering patient benefits such as smaller incisions, less pain, and shorter hospital stay. In one class of MIPs, where natural body lumens or small incisions are used to access deeper anatomical locations, Flexible Surgical and Interventional Robots (FSIRs) such as catheters and endoscopes are widely used. Due to their flexible and compliant nature, FSIRs can be inserted via natural orifices or small incisions, then moved towards hard-to-reach targets to perform interventional tasks. However, existing FSIRs are confronted with challenges in sensing, control, and navigation. These issues stem from the robot's non-linear behavior and the intricate nature of the lumens, where accurately modeling the complex interactions and disturbances proves to be exceptionally difficult. The rapid advances in Machine Learning (ML) have facilitated the widespread adoption of ML techniques in FSIRs. This article provides an overview of these efforts by first introducing a classification of existing ML algorithms, including traditional ML methods and modern Deep Learning (DL) approaches, commonly used in FSIRs. Next, the use of ML algorithms is surveyed per sub-domain, namely for perception, modeling, control, and navigation. Trends, popularity, strengths, and/or limitations of different ML algorithms are analyzed. The different roles that ML plays among tasks are investigated and described. Finally, discussions are conducted on the limitations and the prospects of ML in MIPs.

@en

Our research highlights the potential of Diffuse Reflectance Spectroscopy (DRS) in detecting cortical breaches during pedicle screw placement. We propose a sideways-looking fiber-optic probe, integrating diffuse light emission with both forward and sideways light collection. Experiments on an optical tissue phantom validate the probe’s potential to distinguish bone tissues and provide real-time guidance for spine surgery. Our findings prove that DRS with diffuse emission can detect perpendicular breaches, and demonstrate how the integration of a 45^◦ slanted fiber coated with gold enables parallel breach detection, advancing spine surgery by allowing for accurate pedicle screw placement.

@en

Manipulating a flexible ureteroscope is difficult, due to its bendable body and hand–eye coordination problems, especially when exploring the lower pole of the kidney. Though robotic interventions have been adopted in various clinical scenarios, they are rarely used in ureteroscopy. This study proposes a teleoperation system consists of a soft robotic endoscope together with a Guidance Virtual Fixture (GVF) to help users explore the kidney’s lower pole. The soft robotic arm was a cable-driven, 3D-printed design with a helicoid structure. GVF was dynamically constructed using video streams from an endoscopic camera. With a haptic controller, GVF can provide haptic feedback to guide the users in following a trajectory. In the user study, participants were asked to follow trajectories when the soft robotic arm was in a retroflex posture. The results suggest that the GVF can reduce errors in the trajectory tracking tasks when the users receive the proper training and gain more experience. Based on the NASA Task Load Index questionnaires, most participants preferred having the GVF when manipulating the robotic arm. In conclusion, the results demonstrate the benefits and potential of using a robotic arm with a GVF. More research is needed to investigate the effectiveness of the GVFs and the robotic endoscope in ureteroscopic procedures.@en