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Introduction: Respiratory diseases such as chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, and COVID-19 may cause a decrease in arterial oxygen saturation (SaO 2 ). The continuous monitoring of oxygen levels may be beneficial for the early detection of hypoxemia and timely intervention. Wearable non-invasive pulse oximetry devices measuring peripheral oxygen saturation (SpO 2 ) have been garnering increasing popularity. However, there is still a strong need for extended and robust clinical validation of such devices, especially to address topical concerns about disparities in performances across racial groups. This prospective clinical validation aimed to assess the accuracy of the reflective pulse oximeter function of the EmbracePlus wristband during a controlled hypoxia study in accordance with the ISO 80601-2-61:2017 standard and the Food & Drug Administration (FDA) guidance., Methods: Healthy adult participants were recruited in a controlled desaturation protocol to reproduce mild, moderate, and severe hypoxic conditions with SaO 2 ranging from 100% to 70% (ClinicalTrials.gov registration #NCT04964609). The SpO 2 level was estimated with an EmbracePlus device placed on the participant's wrist and the reference SaO 2 was obtained from blood samples analyzed with a multiwavelength co-oximeter., Results: The controlled hypoxia study yielded 373 conclusive measurements on 15 subjects, including 30% of participants with dark skin pigmentation (V-VI on the Fitzpatrick scale). The accuracy root mean square ( A rms ) error was found to be 2.4%, within the 3.5% limit recommended by the FDA. A strong positive correlation between the wristband SpO 2 and the reference SaO 2 was observed ( r  = 0.96, P  < 0.001), and a good concordance was found with Bland-Altman analysis (bias, 0.05%; standard deviation, 1.66; lower limit, -4.7%; and upper limit, 4.8%). Moreover, acceptable accuracy was observed when stratifying data points by skin pigmentation ( A rms 2.2% in Fitzpatrick V-VI, 2.5% in Fitzpatrick I-IV), and sex ( A rms 1.9% in females, and 2.9% in males)., Discussion: This study demonstrates that the EmbracePlus wristband could be used to assess SpO 2 with clinically acceptable accuracy under no-motion and high perfusion conditions for individuals of different ethnicities across the claimed range. This study paves the way for further accuracy evaluations on unhealthy subjects and during prolonged use in ambulatory settings., Competing Interests: All authors disclose being share-holders of Empatica Inc. and having received a salary or consulting fees from Empatica Inc., which manufactured the EmbracePlus wristband validated in this work. Moreover, RP is a co-founder and chairman of the board of Empatica Inc., (© 2023 Gerboni, Comunale, Chen, Lever Taylor, Migliorini, Picard, Cruz and Regalia.)

The purpose of the present work is to examine, on a clinically diverse population of older adults (N = 46) sleeping at home, the performance of two actigraphy-based sleep tracking algorithms (i.e., Actigraphy-based Sleep algorithm, ACT-S1 and Sadeh's algorithm) compared to manually scored electroencephalography-based PSG (PSG-EEG). ACT-S1 allows for a fully automatic identification of sleep period time (SPT) and within the identified sleep period, the sleep-wake classification. SPT detected by ACT-S1 did not differ statistically from using PSG-EEG (bias = -9.98 min; correlation 0.89). In sleep-wake classification on 30-s epochs within the identified sleep period, the new ACT-S1 presented similar or slightly higher accuracy (83-87%), precision (86-89%) and F1 score (90-92%), significantly higher specificity (39-40%), and significantly lower, but still high, sensitivity (96-97%) compared to Sadeh's algorithm, which achieved 99% sensitivity as the only measure better than ACT-S1's. Total sleep times (TST) estimated with ACT-S1 and Sadeh's algorithm were higher, but still highly correlated to PSG-EEG's TST. Sleep quality metrics of sleep period efficiency and wake-after-sleep-onset computed by ACT-S1 were not significantly different from PSG-EEG, while the same sleep quality metrics derived by Sadeh's algorithm differed significantly from PSG-EEG. Agreement between ACT-S1 and PSG-EEG reached was highest when analyzing the subset of subjects with least disrupted sleep (N = 28). These results provide evidence of promising performance of a full-automation of the sleep tracking procedure with ACT-S1 on older adults. Future longitudinal validations across specific medical conditions are needed. The algorithm's performance may further improve with integrating multi-sensor information.

Direct electrical stimulation of the brain can alleviate symptoms associated with Parkinson's disease, depression, epilepsy and other neurological disorders. However, access to the brain requires invasive procedures, such as the removal of a portion of the skull or the drilling of a burr hole. Also, electrode implantation into tissue can cause inflammatory tissue responses and brain trauma, and lead to device failure. Here, we report the development and application of a chronically implanted platinum electrode array mounted on a nitinol endovascular stent for the localized stimulation of cortical tissue from within a blood vessel. Following percutaneous angiographic implantation of the device in sheep, we observed stimulation-induced responses of the facial muscles and limbs of the animals, similar to those evoked by electrodes implanted via invasive surgery. Proximity of the electrode to the motor cortex, yet not its orientation, was integral to achieving reliable responses from discrete neuronal populations. The minimally invasive endovascular surgical approach offered by the stent-mounted electrode array might enable safe and efficacious stimulation of focal regions in the brain.

Electrical stimulation of neural tissue and recording of neural activity are the bases of emerging prostheses and treatments for spinal cord injury, stroke, sensory deficits, and drug-resistant neurological disorders. Safety and efficacy are key aspects for the clinical acceptance of therapeutic neural stimulators. The cortical vasculature has been shown to be a safe site for implantation of electrodes for chronically recording neural activity, requiring no craniotomy to access high-bandwidth, intracranial EEG. This work presents the first characterization of endovascular cortical stimulation measured using cortical subdural surface recordings. Visual stimulation was used to verify electrode viability and cortical activation was compared with electrically evoked activity. Due to direct activation of the neural tissue, the latency of responses to electrical stimulation was shorter than for that of visual stimulation. We also found that the center of neural activation was different for visual and electrical stimulation indicating an ability of the stentrode to provide localized activation of neural tissue.

Recent work has demonstrated the feasibility of minimally-invasive implantation of electrodes into a cortical blood vessel. However, the effect of the dura and blood vessel on recording signal quality is not understood and may be a critical factor impacting implementation of a closed-loop endovascular neuromodulation system. The present work compares the performance and recording signal quality of a minimally-invasive endovascular neural interface with conventional subdural and epidural interfaces. We compared bandwidth, signal-to-noise ratio, and spatial resolution of recorded cortical signals using subdural, epidural and endovascular arrays four weeks after implantation in sheep. We show that the quality of the signals (bandwidth and signal-to-noise ratio) of the endovascular neural interface is not significantly different from conventional neural sensors. However, the spatial resolution depends on the array location and the frequency of recording. We also show that there is a direct correlation between the signal-noise-ratio and classification accuracy, and that decoding accuracy is comparable between electrode arrays. These results support the consideration for use of an endovascular neural interface in a clinical trial of a novel closed-loop neuromodulation technology.

Background: For some surgical interventions, like the Total Mesorectal Excision (TME), traditional laparoscopes lack the flexibility to safely maneuver and reach difficult surgical targets. This paper answers this need through designing, fabricating and modelling a highly dexterous 2-module soft robot for minimally invasive surgery (MIS)., Methods: A soft robotic approach is proposed that uses flexible fluidic actuators (FFAs) allowing highly dexterous and inherently safe navigation. Dexterity is provided by an optimized design of fluid chambers within the robot modules. Safe physical interaction is ensured by fabricating the entire structure by soft and compliant elastomers, resulting in a squeezable 2-module robot. An inner free lumen/chamber along the central axis serves as a guide of flexible endoscopic tools. A constant curvature based inverse kinematics model is also proposed, providing insight into the robot capabilities., Results: Experimental tests in a surgical scenario using a cadaver model are reported, demonstrating the robot advantages over standard systems in a realistic MIS environment., Conclusion: Simulations and experiments show the efficacy of the proposed soft robot., (Copyright © 2017 John Wiley & Sons, Ltd.)

Robotic needle steering will improve percutaneous radio-frequency ablation (RFA) in the liver by performing distributed ablations without requiring multiple punctures of the liver capsule, thus enabling the treatment of large or multifocal tumors. However, state-of-the-art asymmetric-tip robotic needle steering systems do not yet achieve clinically relevant curvature. This work presents the design and development of a highly articulated needle that enables distributed RFA in liver tissue under ultrasound (US) image guidance. Our new needle design attains the target curvature required for liver procedures while meeting important clinical requirements, such as the use of fixed diameter needle introducers, presence of a free needle working channel, robustness for repeated insertions, and conductivity for the delivery of RF current for tissue ablation. The new needle tip includes two important design features: A tendon-actuated Nitinol asymmetric flexure joint, which allows for an active amplification of the needle steering force, and a steel back-bevel tip profile, which decreases the risk of needle jamming. The needle's resulting curvature was evaluated in both phantom and ex vivo liver tissues using segmented US images. The average radius of minimum curvature in ex vivo liver tissue was found to be 33.6 mm, the smallest reported to date. Furthermore, RFA in ex vivo porcine liver tissue tests were performed to demonstrate that distributedablation with a single puncture of the liver capsule is possible via robotic needle steering.

Background: Sponsored by the European Commission, the FP7 STIFF-FLOP project aimed at developing a STIFFness controllable Flexible and Learn-able manipulator for surgical operations, in order to overcome the current limitations of rigid-link robotic technology. Herein, we describe the first cadaveric series of total mesorectal excision (TME) using a soft and flexible robotic arm for optic vision in a cadaver model., Methods: TME assisted by the STIFF-FLOP robotic optics was successfully performed in two embalmed male human cadavers. The soft and flexible optic prototype consisted of two modules, each measuring 60 mm in length and 14.3 mm in maximum outer diameter. The robot was attached to a rigid shaft connected to an anthropomorphic manipulator robot arm with six degrees of freedom. The controller device was equipped with two joysticks. The cadavers (BMI 25 and 28 kg/m 2 ) were prepared according to the Thiel embalming method. The procedure was performed using three standard laparoscopic instruments for traction and dissection, with the aid of a 30° rigid optics in the rear for documentation., Results: Following mobilization of the left colonic flexure and division of the inferior mesenteric vessels, TME was completed down to the pelvic floor. The STIFF-FLOP robotic optic arm seemed to acquire superior angles of vision of the surgical field in the pelvis, resulting in an intact mesorectum in both cases. Completion times of the procedures were 165 and 145 min, respectively. No intraoperative complications occurred. No technical failures were registered., Conclusions: The STIFF-FLOP soft and flexible robotic optic arm proved effective in assisting a laparoscopic TME in human cadavers, with a superior field of vision compared to the standard laparoscopic vision, especially low in the pelvis. The introduction of soft and flexible robotic devices may aid in overcoming the technical challenges of difficult laparoscopic procedures based on standard rigid instruments.

A major challenge facing neural prostheses is the development of electrodes that are well tolerated by the brain and body. A novel way to circumvent the need to perform an invasive craniotomy and penetration of the blood-brain barrier to implant electrodes, is to guide electrodes up into the cerebral veins and place electrodes on the vessel walls adjacent to neuronal populations. To aid in the development of these stent based devices, microelectrodes manufactured from Nitinol would allow electrodes to be implanted via a catheter and then once deployed, alter their shape to conform to the vessel walls. However, there is a paucity of data on whether Nitinol is a suitable material to record neural signals. Here we show that Nitinol is tolerated by the body and that it can effectively measure neural signals. Specifically, we electrochemically evaluate Nitinol electrodes in blood and record visually evoked potentials from sheep.

Endoscopic endonasal surgery is currently regarded as the 'gold standard' for operating on pituitary gland tumors, and is becoming more and more accepted for treatment of other skull base lesions. However, endoscopic surgical treatment of most skull base pathologies, including certain pituitary tumors, is severely impaired by current instruments lack of maneuverability. Especially, gaining access to, and visibility of, difficult-to-reach anatomical corners without interference with surrounding neurovascular structures or other instruments, is a challenge. In this context there is the need for instruments that are able to provide a stable shaft position, while both the orientation and the position of the end-effector can be independently controlled. Current instruments that allow for this level of maneuverability are usually mechanically complex, and hence less suitable for mass production. This study therefore focuses on the development of a new actuation technique that allows for the required maneuverability while reducing the construction complexity. This actuation technique, referred to as multi-actuation, integrates multiple cable routings into a single steerable structure. Multi-actuation has been successfully integrated and tested in a handheld prototype instrument called HelixFlex. HelixFlex contains a 4 degrees of freedom maneuverable 5.8 mm (diameter) tip and shows promising results concerning its maneuverability and potential rigidity.

In recent years, soft robotics technologies have aroused increasing interest in the medical field due to their intrinsically safe interaction in unstructured environments. At the same time, new procedures and techniques have been developed to reduce the invasiveness of surgical operations. Minimally Invasive Surgery (MIS) has been successfully employed for abdominal interventions, however standard MIS procedures are mainly based on rigid or semi-rigid tools that limit the dexterity of the clinician. This paper presents a soft and high dexterous manipulator for MIS. The manipulator was inspired by the biological capabilities of the octopus arm, and is designed with a modular approach. Each module presents the same functional characteristics, thus achieving high dexterity and versatility when more modules are integrated. The paper details the design, fabrication process and the materials necessary for the development of a single unit, which is fabricated by casting silicone inside specific molds. The result consists in an elastomeric cylinder including three flexible pneumatic actuators that enable elongation and omni-directional bending of the unit. An external braided sheath improves the motion of the module. In the center of each module a granular jamming-based mechanism varies the stiffness of the structure during the tasks. Tests demonstrate that the module is able to bend up to 120° and to elongate up to 66% of the initial length. The module generates a maximum force of 47 N, and its stiffness can increase up to 36%.

Introduction: Steerable instruments are a promising trend in minimally invasive surgery (MIS), due to their manoeuvring capabilities enabling reaching over obstacles. Despite the great number of steerable joint designs, currently available steerable tips tend to be vulnerable to external loading, thus featuring low bending stiffness. This work aims to provide empirical evidence that the bending stiffness can be considerably increased by using fully actuated joint constructions, enabling left/right and up/down tip rotations with the minimum of two degrees of freedom (DOF), rather than conventional underactuated constructions enabling these rotations with more than two DOF., Material and Methods: A steerable MIS instrument prototype with a fully actuated joint construction was compared to state-of-the-art underactuated steerable instruments in a number of tip deflection experiments. The tip deflections due to loading were measured by means of a universal testing machine in four bending scenarios: straight and bent over 20°, 40° and 60°., Results and Conclusions: The experimental results support the claim that a fully actuated joint construction exhibits a significantly larger bending stiffness than an underactuated joint construction. Furthermore, it was shown that the underactuated instrument tips show a considerable difference between their neutral positions before and after loading, which could also be greatly minimised by full actuation.

An overview of clinical, laboratory, and diagnostic imaging features of congenital porto-systemic shunt (PSS) in dogs and cats is presented through the analysis of recent literature, and personal case log. Particular emphasis is given to diagnostic accuracy of ultrasonographic examination of PSS in the evaluation of shunt vessel anatomy, and of ancillary findings such as abnormalities of portal vein flow, portal branches, and liver size. Operative mesenteric portography to obtain information on PSS morphology and position, and quantitative hepatic scintigraphy, which allows the calculation of shunt fractions, are also described. Limitations for each diagnostic imaging technique are given.

The possibility of evaluating periodontal disease status in a given population by examining a limited number of sample teeth is of undoubted value in epidemiological studies. To this end, a cross-section study was performed to assess whether the dental sample proposed by Ramfjord effectively reflects the entire dentition status in terms of the main Clinical Indices of Periodontal Disease, in particular pocket depth. In addition, two randomly selected samples of six teeth were also evaluated using the same criteria. On the basis of their findings, the Authors confirm the epidemiological validity of Ramfjord's dental sample and stress that different groups of sample teeth may be efficaciously used to assess the periodontal disease status of the entire dentition in epidemiological studies.