Laparoscopic surgery offers significant benefits to patients in low-resource settings compared to open surgery such as faster recovery, less pain, and lower infection rate. However, there exist significant barriers to the safe introduction of laparoscopy such as high costs and limited availability of trained staff. Low- and middle-income country (LMIC) hospitals suffer from higher post-surgical infection which might be due to the limited facilities for the sterile reprocessing of laparoscopic instruments. To design a solution to this issue, a detailed understanding of local settings was needed. Therefore, this research applied a context-driven design approach, based on the Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide. Over several design phases, the need for a reprocessing device was established. An analysis of the sterile reprocessing of laparoscopic instruments led to a list of context-specific design requirements. These were translated to a final conceptual design of a laparoscopic instrument cleaner using a waterfall design method. Finally, a usability study of the loading system of the device was conducted with nurses in four Indian hospitals. A root-cause analysis of the usability study showed that the device was not intuitive enough to use for Indian nurses. A redesign of the loading system was made to improve its ease of use. The design process used in this study can be used as an example for designers wanting to address the critical issue of context-specific medical devices worldwide, or more specifically, the sterile supply of surgical instruments in resource-constrained environments.

Background: Laparoscopic surgery requires a complex set of motor skills. Currently, basic laparoscopic skills training is performed in a static environment, while intraoperatively, abdominal tissue is often moving. The aim of this study was to develop a dynamic training platform and evaluate its impact on laparoscopic skills acquisition in a box trainer. Methods: The Dynamic Laparoscopic Platform (DyLaP) includes a moving base which has been intergrated with the Lapron box trainer and the ForceSense objective measurement system. Dynamic training was evaluated in a comparative study where novices were divided into a static and dynamic training group, performing six training trials of a peg transfer task with the DyLaP. Afterwards, both groups performed a dynamic exam task. Task manipulation (force) and instrument efficiency (path length and time) were measured. Results: Participants (n = 12) exhibited a significant difference (p < 0.05) in time, path length, and maximum force between the static and dynamic groups in the first trial. Learning curves were most prevalent in the dynamic group. Conclusions: The DyLaP can be used to provide a challenging and realistic training environment. From the comparative peg transfer study, it can be concluded that dynamic training significantly affects laparoscopic skill acquisition. More research is needed to evaluate dynamic training effects in force-based training tasks.

Background: Preoperative planning of patients diagnosed with pancreatic head cancer is difficult and requires specific expertise. This pilot study assesses the added value of three-dimensional (3D) patient models and computer-aided detection (CAD) algorithms in determining the resectability of pancreatic head tumors. Methods: This study included 14 hepatopancreatobiliary experts from eight hospitals. The participants assessed three radiologically resectable and three radiologically borderline resectable cases in a simulated setting via crossover design. Groups were divided in controls (using a CT scan), a 3D group (using a CT scan and 3D models), and a CAD group (using a CT scan, 3D and CAD). For the perceived fulfillment of preoperative needs, the quality and confidence of clinical decision-making were evaluated. Results: A higher perceived ability to determine degrees and the length of tumor–vessel contact was reported in the CAD group compared to controls (p = 0.022 and p = 0.003, respectively). Lower degrees of tumor–vessel contact were predicted for radiologically borderline resectable tumors in the CAD group compared to controls (p = 0.037). Higher confidence levels were observed in predicting the need for vascular resection in the 3D group compared to controls (p = 0.033) for all cases combined. Conclusions: “CAD (including 3D) improved experts’ perceived ability to accurately assess vessel involvement and supports the development of evolving techniques that may enhance the diagnosis and treatment of pancreatic cancer”.

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.

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.

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.

Background: To validate whether the SATA-LRS, a novel reusable articulating laparoscopic instrument, fits surgical practice, a pre-clinical study was performed. Methods: Thirteen medical doctors used the instrument in a laparoscopic endoscopic inguinal hernia repair (TEP)-like task inside a cadaver. A set of sensors on the instrument handle detected motion and articulation of the instrument tip. Data from the sensors and video recordings were used to assess the amount and type of movement of the instrument and the time spent on tasks. questionnaire was used to gain insight into the participants’ perception of the contextual factors. Results: There was no difference between task time and instrument tip velocities when using articulation (or not) and all participants used articulation at least half of the task time. Instrument-handle movement, indicating the user’s hand and arm movement, was significantly reduced when using articulation. The questionnaire indicated strong acceptance of the instrument and the experimental setup, and a desire to use the instrument in surgery by most participants. Conclusions: The added articulation feature of the SATA-LRS instrument was deemed beneficial by the participants, showed no increased handling complexity or time spent on the task and was used frequently when enabled, indicating intuitiveness.

Introduction: Preterm infants’ growth is typically monitored through weight, body length (BL) and head circumference (HC). However, 3D cranial volume (CrV) is considered a more accurate indicator of brain growth than 2D HC. The PreemieScanner is a novel 3D measuring device that simultaneously measures BL, HC and CrV. Its clinical usability was tested in a simulated NICU setting. Materials and methods: Three extremely low birth weight (ELBW; BW < 1,000 gram) dolls with Optiflow breathing systems, (tubes positioned either at the front or back of the head) were used. Nurses conducted scan sessions and marked anatomical landmarks on 3D PreemieScanner images. As control, nurses measured HC manually with a standard measuring tape. Key outcomes were: (1) Measurement success rate, (2) Precision—percentage within clinically allowed limits, ±0.4 cm for BL, ±0.3 cm for HC, ±12 ml for CrV, and 3) accuracy—mean or median measurement error (MME) relative to the ground truth. Results: Thirty-five scan sessions resulted in 100% successful measurements for BL and HC; 80% for CrV. BL MME −3.3% (p < 0.001); 40% (42/105) within precision limits. HC MME (Optiflow-front) 0.0% (p = 0.63); 89% (51/57) within limits. HC MME (Optiflow-back) −0.4% (p = 0.91). 93% (43/46) within limits. MME HC measuring tape, (Optiflow-front) −0.8% (p < 0.001), 88% (50/57) within limits, and MME (Optiflow-back) −1.1% (p < 0.001), 83% (40/48) within limits. MME CrV (Optiflow-front) −1.8% (p = 0.01), 86% (31/36) within limits, MME CrV (Optiflow-back) −1.3% (p < 0.001), 98% (45/46) within limits. Conclusions: The PreemieScanner is a reliable, comprehensive device for measuring BL, HC and CrV in ELBW infants. It integrates smoothly into routine care with minimal disturbance. HC measurements demonstrated higher accuracy and precision than traditional tape method. CrV measurements, with 93% within precision limits, can be regarded as acceptable, enabling development of CrV growth reference charts, enhancing clinical growth monitoring.

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.

Peripheral autonomic nerve function (ANF) impairment (ANFI) can be one of the first indicators for leprosy or leprosy neuropathy. However, within leprosy, hardly any ANF assessment methods are used in current practice. Skin temperature could be a proxy measure to assess ANF. Therefore, this research aims to explore whether low-cost infrared (IR) video thermography can be used as an ANF assessment tool by measuring the skin temperature response (STR) of human hands before, and after applying a cold pressor test (CPT). A protocol was defined to perform a baseline measurement, apply CPT, and record the resulting STR curve during 15 minutes. An IR video camera connected to a mobile phone was selected as sensor. A setup was developed to immobilize the position of the hands and fingers relative to the camera. A Python script was developed to extract the hand palm skin temperature STR curve from an IR video for 12 ulnar and median innervated regions of interest (ROI) in 1s intervals. A Matlab script was developed to post-process the raw temperature data into filtered data. This data is used to calculate key metrics that describe the STR curve. This approach was evaluated on technical accuracy and precision by comparing IR data for 3 cameras to a reference sensor. The variability caused by the observer analyzing the data was studied by analyzing the same video 5 times by 2 observers. The subject variability was studied by enrolling 7 subjects into a pilot, testing them daily for 5 consecutive days. The results show a high mean Interclass correlation of 0.94 between the 3 IR cameras and the reference sensor. Bland-Altman plots show a mean accuracy of +0.090°C between the cameras and the reference, and a variation between −1.30 and +1.50°C. High agreement was shown between observers analyzing the data. The pilot test showed high variability in STR curve within subjects. Although the general shape of the STR was similar, the location of the steep increase in recovery varied strongly within and between subjects. This study shows that a low-cost, portable IR camera can be used to measure STR of human hands after CPT. A pilot study showed high subject variability for repeated testing of the STR curve. Future research is needed to establish its value in assessing ANF in leprosy patients or other systemic and local neuropathies and traumatic nerve conditions.

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.

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.

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.

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.

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.

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.

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.

Objective: Detecting the cancerous growth margin and achieving a negative margin is one of the challenges that surgeons face during cancer procedures. A smart electrosurgical knife with integrated optical fibers has been designed previously to enable real-time use of diffuse reflectance spectroscopy for intraoperative margin assessment. In this paper, the thermal effect of the electrosurgical knife on tissue sensing is investigated. Methods: Porcine tissues and phantoms were used to investigate the performance of the smart electrosurgical knife after electrosurgery. The fat-to-water content ratio (F/W-ratio) served as the discriminative parameter for distinguishing tissues and tissue mimicking phantoms with varying fat content. The F/W-ratio of tissues and phantoms was measured with the smart electrosurgical knife before and after 14 minutes of electrosurgery. Additionally, a layered porcine tissue and phantom were sliced and measured from top to bottom with the smart electrosurgical knife. Results: Mapping the thermal activity of the electrosurgical knife's electrode during animal tissue electrosurgery revealed temperatures exceeding 400 °C. Electrosurgery for 14 minutes had no impact on the device's accurate detection of the F/W-ratio. The smart electrosurgical knife enables real-time tissue detection and predicts the fat content of the next layer from 4 mm ahead. Conclusion: The design of the smart electrosurgical knife outlined in this paper demonstrates its potential utility for tissue detection during electrosurgery. Significance: In the future, the smart electrosurgical knife could be a valuable intraoperative margin assessment tool, aiding surgeons in detecting tumor borders and achieving negative margins.