A sensorised surgical glove to improve training and detection of obstetric anal sphincter injury: A preclinical study on a pig model.

OBJECTIVE: To create a sensorised surgical glove that can accurately identify obstetric anal sphincter injury to facilitate timely repair, reduce complications and aid training. DESIGN: Proof-of-concept. SETTING: Laboratory. SAMPLE: Pig models. METHODS: Flexible triboelectric pressure/force sensors were mounted onto the fingertips of a routine surgical glove. The sensors produce a current when rubbed on materials of different characteristics which can be analysed. A per rectum examination was performed on the intact sphincter of pig cadavers, analogous to routine examination for obstetric anal sphincter injuries postpartum. An anal sphincter defect was created by cutting through the vaginal mucosa and into the external anal sphincter using a scalpel. The sphincter was then re-examined. Data and signals were interpreted. MAIN OUTCOME MEASURES: Sensitivity and specificity of the glove in detecting anal sphincter injury. RESULTS: In all, 200 examinations were performed. The sensors detected anal sphincter injuries in a pig model with sensitivities between 98% and 100% and a specificity of 100%. The current produced when examining an intact sphincter and sphincter with a defect was significantly different (p < 0.001). CONCLUSION: In this preliminary study, the sensorised glove accurately detected anal sphincter injury in a pig model. Future plans include its clinical translation, starting with an in-human study on postpartum women, to determine whether it can accurately detect different types of obstetric anal sphincter injury in vivo.

A Deep Learning Approach to Classify Surgical Skill in Microsurgery Using Force Data from a Novel Sensorised Surgical Glove.

Microsurgery serves as the foundation for numerous operative procedures. Given its highly technical nature, the assessment of surgical skill becomes an essential component of clinical practice and microsurgery education. The interaction forces between surgical tools and tissues play a pivotal role in surgical success, making them a valuable indicator of surgical skill. In this study, we employ six distinct deep learning architectures (LSTM, GRU, Bi-LSTM, CLDNN, TCN, Transformer) specifically designed for the classification of surgical skill levels. We use force data obtained from a novel sensorized surgical glove utilized during a microsurgical task. To enhance the performance of our models, we propose six data augmentation techniques. The proposed frameworks are accompanied by a comprehensive analysis, both quantitative and qualitative, including experiments conducted with two cross-validation schemes and interpretable visualizations of the network's decision-making process. Our experimental results show that CLDNN and TCN are the top-performing models, achieving impressive accuracy rates of 96.16% and 97.45%, respectively. This not only underscores the effectiveness of our proposed architectures, but also serves as compelling evidence that the force data obtained through the sensorized surgical glove contains valuable information regarding surgical skill.

A synthetic model simulator for intracranial aneurysm clipping: validation of the UpSurgeOn AneurysmBox.

Background and objectives: In recent decades, the rise of endovascular management of aneurysms has led to a significant decline in operative training for surgical aneurysm clipping. Simulation has the potential to bridge this gap and benchtop synthetic simulators aim to combine the best of both anatomical realism and haptic feedback. The aim of this study was to validate a synthetic benchtop simulator for aneurysm clipping (AneurysmBox, UpSurgeOn). Methods: Expert and novice surgeons from multiple neurosurgical centres were asked to clip a terminal internal carotid artery aneurysm using the AneurysmBox. Face and content validity were evaluated using Likert scales by asking experts to complete a post-task questionnaire. Construct validity was evaluated by comparing expert and novice performance using the modified Objective Structured Assessment of Technical Skills (mOSATS), developing a curriculum-derived assessment of Specific Technical Skills (STS), and measuring the forces exerted using a force-sensitive glove. Results: Ten experts and eighteen novices completed the task. Most experts agreed that the brain looked realistic (8/10), but far fewer agreed that the brain felt realistic (2/10). Half the expert participants (5/10) agreed that the aneurysm clip application task was realistic. When compared to novices, experts had a significantly higher median mOSATS (27 vs. 14.5; p < 0.01) and STS score (18 vs. 9; p < 0.01); the STS score was strongly correlated with the previously validated mOSATS score (p < 0.01). Overall, there was a trend towards experts exerting a lower median force than novices, however, these differences were not statistically significant (3.8 N vs. 4.0 N; p = 0.77). Suggested improvements for the model included reduced stiffness and the addition of cerebrospinal fluid (CSF) and arachnoid mater. Conclusion: At present, the AneurysmBox has equivocal face and content validity, and future versions may benefit from materials that allow for improved haptic feedback. Nonetheless, it has good construct validity, suggesting it is a promising adjunct to training.

A Triboelectric Nanocomposite for Sterile Sensing, Energy Harvesting, and Haptic Diagnostics in Interventional Procedures from Surgical Gloves.

Advanced interfacial engineering has the potential to enable the successful realization of three features that are particularly important for a variety of healthcare applications: wettability control, antimicrobial activity to reduce infection risks, and sensing of physiological parameters. Here, a sprayable multifunctional triboelectric coating is exploited as a nontoxic, ultrathin tactile sensor that can be integrated directly on the fingertips of surgical gloves. The coating is based on a polymer blend mixed with zinc oxide (ZnO) nanoparticles, which enables antifouling and antibacterial properties. Additionally, the nanocomposite is superhydrophobic (self-cleaning) and is not cytotoxic. The coating is also triboelectric and can be applied directly onto surgical gloves with printed electrodes. The sensorized gloves so obtained enable mechanical energy harvesting, force sensing, and detection of materials stiffness changes directly from fingertip, which may complement proprioceptive feedback for clinicians. Just as importantly, the sensors also work with a second glove on top offering better reassurance regarding sterility in interventional procedures. As a case study of clinical use for stiffness detection, the sensors demonstrate successful detection of pig anal sphincter injury ex vivo. This may lead to improving the accuracy of diagnosing obstetric anal sphincter injury, resulting in prompt repair, fewer complications, and improved quality of life.

A Sensorised Surgical Glove to Analyze Forces During Neurosurgery.

BACKGROUND: Measuring intraoperative forces in real time can provide feedback mechanisms to improve patient safety and surgical training. Previous force monitoring has been achieved through the development of specialized and adapted instruments or use designs that are incompatible with neurosurgical workflow. OBJECTIVE: To design a universal sensorised surgical glove to detect intraoperative forces, applicable to any surgical procedure, and any surgical instrument in either hand. METHODS: We created a sensorised surgical glove that was calibrated across 0 to 10 N. A laboratory experiment demonstrated that the sensorised glove was able to determine instrument-tissue forces. Six expert and 6 novice neurosurgeons completed a validated grape dissection task 20 times consecutively wearing the sensorised glove. The primary outcome was median and maximum force (N). RESULTS: The sensorised glove was able to determine instrument-tissue forces reliably. The average force applied by experts (2.14 N) was significantly lower than the average force exerted by novices (7.15 N) ( P = .002). The maximum force applied by experts (6.32 N) was also significantly lower than the maximum force exerted by novices (9.80 N) ( P = .004). The sensorised surgical glove's introduction to operative workflow was feasible and did not impede on task performance. CONCLUSION: We demonstrate a novel and scalable technique to detect forces during neurosurgery. Force analysis can provide real-time data to optimize intraoperative tissue forces, reduce the risk of tissue injury, and provide objective metrics for training and assessment.

Preventing stillbirth from obstructed labor: A sensorized, low-cost device to train in safer operative birth.

Background: 98% of stillbirths occur in low- and middle- income countries. Obstructed labor is a common cause for both neonatal and maternal mortality, with a lack of skilled birth attendants one of the main reasons for the reduction in operative vaginal birth, especially in low- and middle- income countries. We introduce a low cost, sensorized, wearable device for digital vaginal examination to facilitate accurate assessment of fetal position and force applied to the fetal head, to aid training in safe operative vaginal birth. Methods: The device consists of flexible pressure/force sensors mounted onto the fingertips of a surgical glove. Phantoms of the neonatal head were developed to replicate sutures. An Obstetrician tested the device on the phantoms by performing a mock vaginal examination at full dilatation. Data was recorded and signals interpreted. Software was developed so that the glove can be used with a simple smartphone app. A patient and public involvement panel was consulted on the glove design and functionality. Results: The sensors achieved a 20 Newton force range and a 0.1 Newton sensitivity, leading to 100% accuracy in detecting fetal sutures, including when different degrees of molding or caput were present. They also detected sutures and force applied with a second sterile surgical glove on top. The software developed allowed a force threshold to be set, alerting the clinician when excessive force is applied. Patient and public involvement panels welcomed the device with great enthusiasm. Feedback indicated that women would accept, and prefer, clinicians to use the device if it could improve safety and reduce the number of vaginal examinations required. Conclusion: Under phantom conditions to simulate the fetal head in labor, the novel sensorized glove can accurately determine fetal sutures and provide real-time force readings, to support safer clinical training and practice in operative birth. The glove is low cost (approximately 1 USD). Software is being developed so fetal position and force readings can be displayed on a mobile phone. Although substantial steps in clinical translation are required, the glove has the potential to support efforts to reduce the number of stillbirths and maternal deaths secondary to obstructed labor in low- and -middle income countries.

Copper nanowire embedded hypromellose: An antibacterial nanocomposite film.

The present work reports a novel antibacterial nanocomposite film comprising of copper nanowire impregnated biocompatible hypromellose using polyethylene glycol as a plasticiser. Detailed physico-chemical characterization using X-ray diffraction, Fourier transform infrared spectroscopy, UV-Visible spectroscopy and electron microscopy shows uniform dispersion of copper nanowire in the polymer matrix without any apparent oxidation. The film is flexible and shows excellent antibacterial activity against both Gram positive and negative bacteria at 4.8 wt% nanowire loading with MIC values of 400 µg/mL and 500 µg/mL for E. coli and S. aureus respectively. Investigation into the antibacterial mechanism of the nanocomposite indicates multiple pathways including cellular membrane damage caused by released copper ions and reactive oxygen species generation in the microbial cell. Interestingly, the film showed good biocompatibility towards normal human dermal fibroblast at minimum bactericidal concentration (MBC). Compared to the copper nanoparticles reported earlier in vitro studies, this low cytotoxicity of copper nanowires is due to the slow dissolution rate of the film and production of lower amount of ROS producing Cu2+ ions. Thus, the study indicates a strong potential for copper nanowire-based composites films in broader biomedical and clinical applications.