Extending the understanding of Shannon's safe stimulation limit for platinum electrodes: biphasic charge-balanced pulse trains in unbuffered saline at pH = 1 to pH = 12.

OBJECTIVE: In neural electrical stimulation, safe stimulation guidelines are essential to deliver efficient treatment by avoiding neural damage and electrode degradation. The widely used Shannon's limit, k, gives conditions on the stimulation parameters to avoid neural damage, however, underlying damage mechanisms are not fully understood. Moreover, the translation from bench testing to in vivo experiments still presents some challenges, including the increased polarisation observed, which may influence charge-injection mechanisms. In this work, we studied the influence on damage mechanisms of two electrolyte parameters that are different in vivo compared to usual bench tests: solution pH and electrolyte gelation. APPROACH: The potential of a platinum macroelectrode was monitored in a three-electrode setup during current-controlled biphasic charge-balanced cathodic-first pulse trains. Maximum anodic and cathodic potential excursions during pulse trains were projected on cyclic voltammograms to infer possible electrochemical reactions. MAIN RESULTS: In unbuffered saline of pH ranging from 1 to 12, the maximum anodic potential was systematically located in the oxide formation region, while the cathodic potential was located the molecular oxygen and oxide reduction region when k approached Shannon's damage limit, independent of solution pH. The results support the hypothesis that Shannon's limit corresponds to the beginning of platinum dissolution following repeated cycles of platinum oxidation and reduction, for which the cathodic excursion is a key tipping point. Despite similar potential excursions between solution and gel electrolytes, we found a joint influence of pH and gelation on the cathodic potential alone, while we observed no effect on the anodic potential. We hypothesise that gelation creates a positive feedback loop exacerbating the effects of pH ; however, the extent of that influence needs to be examined further. SIGNIFICANCE: This work supports the hypothesis of charge injection mechanisms associated with stimulation-induced damage at platinum electrodes. The validity of a major hypothesis explaining stimulation-induced damage was tested and supported on a range of electrolytes representing potential electrode environments, calling for further characterisation of platinum dissolution during electrical stimulation in various testing conditions.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.

Medical device regulatory challenges in the UK are affecting innovation and its potential benefits.

The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.

Urinary bladder phantom mimicking mechanical properties and pressure during filling.

Objective.Phantoms that mimic healthy or diseased organ properties can complement animal models for surgical planning, training, and medical device development. If urodynamic studies rely on pressure-volume curves to assess lower urinary tract symptoms, there is an unsatisfied need for a bladder phantom that accurately mimics the bladder stretching capabilities and compliant behaviour during physiological filling.Approach.We demonstrate the suitability of water-soluble 3D-printed moulds as a versatile method to fabricate accurate phantoms with anatomical structures reconstructed from medical images. We report a phantom fabricated with silicone rubber. A wire net limits the silicone expansion to model the cystometric capacity. A mathematical model describes the pressure increase due to passive hyperelastic properties.Main results.The phantom reproduces the bladder's mechanical properties during filling. The pressure-volume curve measured on the phantom is typical of cystometric studies, with a compliance of 25.2 ± 1mlcmH2O-1.The root-mean-square error between the theoretical model and experimental data is 2.7cmH2O.The compliance, bladder wall thickness, cystometric capacity and pressure near the cystometric capacity of the phantom can be tuned to mimic various pathologies or human variability.Significance.The manufacturing method is suitable for fabricating bladder and other soft and hollow organ phantoms. The mathematical model provides a method to determine design parameters to model healthy or diseased bladders. Soft hollow organ phantoms can be used to complement animal experimentations for developing and validating medical devices aiming to be anchored on these organs or monitor their activity through pressure and strain measurement.

Methods of poly(3,4)-ethylenedioxithiophene (PEDOT) electrodeposition on metal electrodes for neural stimulation and recording.

Conductive polymers are of great interest in the field of neural electrodes because of their potential to improve the interfacial properties of electrodes. In particular, the conductive polymer poly (3,4)-ethylenedioxithiophene (PEDOT) has been widely studied for neural applications.Objective:This review compares methods for electrodeposition of PEDOT on metal neural electrodes, and analyses the effects of deposition methods on morphology and electrochemical performance.Approach:Electrochemical performances were analysed against several deposition method choices, including deposition charge density and co-ion, and correlations were explained to morphological and structural arguments as well as characterisation methods choices.Main results:Coating thickness and charge storage capacity are positively correlated with PEDOT electrodeposition charge density. We also show that PEDOT coated electrode impedance at 1 kHz, the only consistently reported impedance quantity, is strongly dependent upon electrode radius across a wide range of studies, because PEDOT coatings reduces the reactance of the complex impedance, conferring a more resistive behaviour to electrodes (at 1 kHz) dominated by the solution resistance and electrode geometry. This review also summarises how PEDOT co-ion choice affects coating structure and morphology and shows that co-ions notably influence the charge injection limit but have a limited influence on charge storage capacity and impedance. Finally we discuss the possible influence of characterisation methods to assess the robustness of comparisons between published results using different methods of characterisation.Significance:This review aims to serve as a common basis for researchers working with PEDOT by showing the effects of deposition methods on electrochemical performance, and aims to set a standard for accurate and uniform reporting of methods.

Optical birefringence changes in myelinated and unmyelinated nerves: A comparative study.

The measurement of birefringence variations related to nerve activity is a promising label-free technique for sensing compound neural action potentials (CNAPs). While widely applied in crustaceans, little is known about its efficiency on mammal peripheral nerves. In this work, birefringence recordings to detect CNAPs, and Stokes parameters measurements were performed in rat and lobster nerves. While single-trial detection of nerve activity in crustaceans was achieved successfully, no optical signal was detected in rats, even after extensive signal filtering and averaging. The Stokes parameters showed that a high degree of polarization of light is maintained in lobster sample, whereas an almost complete light depolarization occurs in rat nerve. Our results indicate that depolarization itself is not sufficient to explain the absence of birefringence signals in rats. We hypothesize that this absence comes from the myelin sheets, which constraint the birefringence changes to only take place at the nodes of Ranvier.

Chronic recording of the vagus nerve to analyze modulations by the light-dark cycle.

Objective.The vagus nerve is considered to play a key role in the circadian rhythm. Chronic continuous analysis of the vagus nerve activity could contribute to a better understanding of the role of the vagus nerve in light-dark modulations. This paper presents a continuous analysis of spontaneous vagus nerve activity performed in four rats.Approach.We analyzed the vagus electroneurogram (VENG) and electroencephalogram (EEG) over a recording period of 28 d. Spike activity and heart rate estimation were derived from the VENG, and slow-wave activity was derived from the EEG. The presence of repetitive patterns was investigated with periodograms, cosinor fitting, autocorrelation, and statistical tests. The light-dark variations derived from the VENG spikes were compared with EEG slow waves, an established metric in circadian studies.Results.Our results demonstrate that light-dark variations can be detected in long-term vagus nerve activity monitoring. A recording period of about 7 d is required to characterize accurately the VENG light-dark variations.Significance.As a major outcome of this study, vagus nerve recordings hold the promise to help understand circadian regulation.

Environmental sustainability in robotic and laparoscopic surgery: systematic review.

BACKGROUND: Minimally invasive surgical (MIS) techniques are considered the gold standard of surgical interventions, but they have a high environmental cost. With global temperatures rising and unmet surgical needs persisting, this review investigates the carbon and material footprint of MIS and summarizes strategies to make MIS greener. METHODS: The MEDLINE, Embase, and Web of Science databases were interrogated between 1974 and July 2021. The search strategy encompassed surgical setting, waste, carbon footprint, environmental sustainability, and MIS. Two investigators independently performed abstract/full-text reviews. An analysis of disability-adjusted life years (DALYs) averted per ton of carbon dioxide equivalents (CO2e) or waste produced was generated. RESULTS: From the 2456 abstracts identified, 16 studies were selected reporting on 5203 MIS procedures. Greenhouse gas (GHG) emissions ranged from 6 kg to 814 kg CO2e per case. Carbon footprint hotspots included production of disposables and anaesthetics. The material footprint of MIS ranged from 0.25 kg to 14.3 kg per case. Waste-reduction strategies included repackaging disposables, limiting open and unused instruments, and educational interventions. Robotic procedures result in 43.5 per cent higher GHG emissions, 24 per cent higher waste production, fewer DALYs averted per ton of CO2, and less waste than laparoscopic alternatives. CONCLUSION: The increased environmental impact of robotic surgery may not sufficiently offset the clinical benefit. Utilizing alternative surgical approaches, reusable equipment, repackaging, surgeon preference cards, and increasing staff awareness on open and unused equipment and desflurane avoidance can reduce GHG emissions and waste.

Neurophysiological and clinical outcome measures of the impact of electrical stimulation on spasticity in spinal cord injury: Systematic review and meta-analysis.

This systematic review and meta-analysis aims to determine whether non-invasive electrical stimulation (ES) is effective at reducing spasticity in people living with spinal cord injury (SCI). PubMed, Web of Science, Scopus and Cochrane Central Register of Controlled Trials databases were searched in April 2022. Primary outcome measures were the Ashworth scale (AS), Modified Ashworth scale (MAS), Pendulum test and the Penn spasm frequency scale (PSFS). Secondary outcomes were the Hoffman (H)- reflex, motor-evoked potentials (MEPs) and posterior-root reflexes (PRRs). A random-effects model, using two correlation coefficients, ( C o r r = 0.1 , C o r r = 0.2 ) determined the difference between baseline and post-intervention measures for RCTs. A quantitative synthesis amalgamated data from studies with no control group (non-RCTs). Twenty-nine studies were included: five in the meta-analysis and 17 in the amalgamation of non-RCT studies. Twenty studies measured MAS or AS scores, 14 used the Pendulum test and one used the PSFS. Four measured the H-reflex and no studies used MEPs or PRRs. Types of ES used were: transcutaneous electrical nerve stimulation (TENS), transcutaneous spinal cord stimulation (TSCS), functional electrical stimulation (FES) cycling and FES gait. Meta-analyses of 3 studies using the MAS and 2 using the Pendulum test were carried out. For MAS scores, non-invasive ES was effective at reducing spasticity compared to a control group (p = 0.01, C o r r = 0.1 ; p = 0.002, C o r r = 0.2 ). For Pendulum test outcomes, there was no statistically significant difference between intervention and control groups. Quantitative synthesis of non-RCT studies revealed that 22 of the 29 studies reported improvement in at least one measure of spasticity following non-invasive ES, 13 of which were statistically significant (p < 0.05). Activation of the muscle was not necessary to reduce spasticity. Non-invasive ES can reduce spasticity in people with SCI, according to MAS scores, for both RCT and non-RCT studies, and Pendulum test values in non-RCT studies. This review could not correlate between clinical and neurophysiological outcomes; we recommend the additional use of neurophysiological outcomes for future studies. The use of TSCS and TENS, which did not induce a muscle contraction, indicate that activation of afferent fibres is at least required for non-invasive ES to reduce spasticity.

Impact of adaptive gastric electrical stimulation on weight, food intake, and food intake rate in dogs.

BACKGROUND: Gastric electrical stimulation (GES) has been studied for decades as a promising treatment for obesity. Stimulation pulses with fixed amplitude and pulse width are usually applied, but these have limitations with regard to overcoming habituation to GES and inter-subject variation. This study aims to analyze the efficacy of an adaptive GES protocol for reducing food intake and maintaining lean weight in dogs. METHODS: Six beagle dogs were implanted with a remotely programmable gastric stimulator. An adaptive protocol was designed to increase the stimulation energy proportionally to the excess of food consumption, with respect to the dogs' maintenance energy requirements. After surgery and habituation to experimental conditions, the dogs went through both a control and a stimulation period of 4 weeks each, in a randomized order. The stimulation parameters were adapted daily. Body weight, food intake, food intake rate, and postprandial cutaneous electrogastrograms (EGG) were recorded to assess the effect of adaptive GES. RESULTS: Adaptive GES decreased food intake and food intake rate (p < 0.05) resulting in weight maintenance. In the absence of GES, the dogs gained weight (p < 0.05). Postprandial EGG dominant frequency was accelerated by GES (p < 0.05). The strategy of adapting the stimulation energy was effective in causing significant mid-term changes. CONCLUSION: Adaptive GES is effective for reducing food intake and maintaining lean weight. The proposed adaptive strategy may offer benefits to counter habituation and adapt to inter-subject variation in clinical use of GES for obesity.

Prediction of larynx function using multichannel surface EMG classification.

Total laryngectomy (TL) affects critical functions such as swallowing, coughing and speaking. An artificial, bio-engineered larynx (ABL), operated via myoelectric signals, may improve quality of life for TL patients. To evaluate the efficacy of using surface electromyography (sEMG) as a control signal to predict instances of swallowing, coughing and speaking, sEMG was recorded from submental, intercostal and diaphragm muscles. The cohort included TL and control participants. Swallowing, coughing, speaking and movement actions were recorded, and a range of classifiers were investigated for prediction of these actions. Our algorithm achieved F1-scores of 76.0 ± 4.4 % (swallows), 93.8 ± 2.8 % (coughs) and 70.5 ± 5.4 % (speech) for controls, and 67.7 ± 4.4 % (swallows), 71.0 ± 9.1 % (coughs) and 78.0 ± 3.8 % (speech) for TLs, using a random forest (RF) classifier. 75.1 ± 6.9 % of swallows were detected within 500 ms of onset in the controls, and 63.1 ± 6.1 % in TLs. sEMG can be used to predict critical larynx movements, although a viable ABL requires improvements. Results are particularly encouraging as they encompass a TL cohort. An ABL could alleviate many challenges faced by laryngectomees. This study represents a promising step toward realising such a device.

An Assistive Coughing Device for Post-Laryngectomy Patients.

People who have undergone total laryngectomy typically have difficulties speaking and coughing. Coughing, the protective reflex action where air is rapidly expelled from the lungs to clear the airway, is crucial in everyday life. Insufficiency in coughing can lead to serious chest infections. In this research we present a bionic assistive coughing device (RoboCough) to improve coughing efficacy among laryngectomy patients by increasing pressure and flow rate. RoboCough was designed to mimic the function of the glottis and trachea in the upper respiratory system. Experimental results show a significant increase (t(64) = 4.9, p < 0.0001) in peak cough flow rate and peak cough pressure (t(64) = 12.6, p < 0.0001) among 33 control participants using RoboCough. A pilot study with a smaller cohort of laryngectomy patients shows improvement in peak cough pressure (p = 0.0159) using RoboCough. Preliminary results also show that post-laryngectomy coughs achieved similar peak cough flow (Z = -0.9933, p = 0.32) to the control group's natural cough. Coughing capabilities could be improved through using RoboCough. Applications of RoboCough include simulation of vocal folds and respiratory conditions, rehabilitation of ineffective coughs from laryngeal and respiratory diseases and as a test-bed for the development of medical devices for respiratory support.

A Versatile Hermetically Sealed Microelectronic Implant for Peripheral Nerve Stimulation Applications.

This article presents a versatile neurostimulation platform featuring a fully implantable multi-channel neural stimulator for chronic experimental studies with freely moving large animal models involving peripheral nerves. The implant is hermetically sealed in a ceramic enclosure and encapsulated in medical grade silicone rubber, and then underwent active tests at accelerated aging conditions at 100°C for 15 consecutive days. The stimulator microelectronics are implemented in a 0.6-µm CMOS technology, with a crosstalk reduction scheme to minimize cross-channel interference, and high-speed power and data telemetry for battery-less operation. A wearable transmitter equipped with a Bluetooth Low Energy radio link, and a custom graphical user interface provide real-time, remotely controlled stimulation. Three parallel stimulators provide independent stimulation on three channels, where each stimulator supports six stimulating sites and two return sites through multiplexing, hence the implant can facilitate stimulation at up to 36 different electrode pairs. The design of the electronics, method of hermetic packaging and electrical performance as well as in vitro testing with electrodes in saline are presented.

Optimization and assessment of a novel gastric electrode anchoring system designed to be implanted by minimally invasive surgery.

A novel electrode anchoring design and its implantation procedure, aiming for a minimally invasive solution for gastric electrical stimulation, are presented. The system comprises an anchor made of a flexible body embedding two needle-shaped electrodes. The electrodes can easily switch from a parallel position - to pierce the stomach - to a diverging position - enabling them to remain firmly anchored into the muscular layer of the stomach. Key device parameters governing anchoring stability were assessed on a traction test bench, and optimal values were derived. The device was then implanted in six dogs by open surgery to assess its anchoring durability in vivo. Computed tomography images showed that the electrodes remained well placed within the dogs' gastric wall over the entire assessment period (more than one year). Finally, a prototype of a surgical tool for the minimally invasive device placement was manufactured, and the anchoring procedure was tested on a dog cadaver, providing the proof of concept of the minimally invasive implantation procedure. The use of our electrode anchoring system in long-term gastric electrical stimulation is promising in terms of implantation stability (the anchor withstands a force up to 0.81 N), durability (the anchor remains onto the stomach over one year) and minimal invasiveness of the procedure (the diameter of the percutaneous access is smaller than 12 mm). Moreover, the proposed design could have clinical applications in other hollow organs, such as the urinary bladder.

Infrared neurostimulation inex-vivorat sciatic nerve using 1470 nm wavelength.

Objective.To design and implement a setup forex-vivooptical stimulation for exploring the effect of several key parameters (optical power and pulse duration), activation features (threshold, spatial selectivity) and recovery characteristics (repeated stimuli) in peripheral nerves.Approach.A nerve chamber allowing ex-vivo electrical and optical stimulation was designed and built. A 1470 nm light source was chosen to stimulate the nerve. A photodiode module was implemented for synchronization of the electrical and optical channels.Main results. Compound neural action potentials (CNAPs) were successfully generated with infrared light pulses of 200-2000µs duration and power in the range of 3-10 W. These parameters determine a radiant exposure for stimulation in the range 1.59-4.78 J cm-2. Recruitment curves were obtained by increasing durations at a constant power level. Neural activation threshold is reached at a mean radiant exposure of 3.16 ± 0.68 J cm-2and mean pulse energy of 3.79 ± 0.72 mJ. Repetition rates of 2-10 Hz have been explored. In eight out of ten sciatic nerves (SNs), repeated light stimuli induced a sensitization effect in that the CNAP amplitude progressively grows, representing an increasing number of recruited fibres. In two out of ten SNs, CNAPs were composed of a succession of peaks corresponding to different conduction velocities.Significance.The reported sensitization effect could shed light on the mechanism underlying infrared neurostimulation. Our results suggest that, in sharp contrast with electrical stimuli, optical pulses could recruit slow fibres early on. This more physiological order of recruitment opens the perspective for specific neuromodulation of fibre population who remained poorly accessible until now. Short high-power light pulses at wavelengths below 1.5µm offer interesting perspectives for neurostimulation.

Analysing vagus nerve spontaneous activity using finite element modelling.

Objective.Finite element modelling has been widely used to understand the effect of stimulation on the nerve fibres. Yet the literature on analysis of spontaneous nerve activity is much scarcer. In this study, we introduce a method based on a finite element model, to analyse spontaneous nerve activity with a typical bipolar electrode recording setup, enabling the identification of spontaneously active fibres. We applied our method to the vagus nerve, which plays a key role in refractory epilepsy.Approach.We developed a 3D model including dynamic action potential (AP) propagation, based on the vagus nerve geometry. The impact of key recording parameters-inter-electrode distance and temperature-and uncontrolled parameters-fibre size and position in the nerve-on the ability to discriminate active fibres were quantified. A specific algorithm was implemented to detect and classify APs from recordings, and tested on six ratin-vivovagus nerve recordings.Main results.Fibre diameters can be discriminated if they are below 3µm and 7µm, respectively for inter-electrode distances of 2 mm and 4 mm. The impact of the position of the fibre inside the nerve on fibre diameter discrimination is limited. The range of active fibres identified by modelling in the vagus nerve of rats is in agreement with ranges found at histology.Significance.The nerve fibre diameter, directly proportional to the AP propagation velocity, is related to a specific physiological function. Estimating the source fibre diameter is thus essential to interpret neural recordings. Among many possible applications, the present method was developed in the context of a project to improve vagus nerve stimulation therapy for epilepsy.

Triggering Postural Movements With Virtual Reality Technology in Healthy Young and Older Adults: A Cross-Sectional Validation Study for Early Dementia Screening.

With the ultimate aim of early diagnosis of dementia, a new body balance assessment system with integrated head-mounted display-based virtual reality (VR) has been developed. We hypothesized that people would sway more in anterior-posterior (AP) direction when they were exposed to a VR environment where we intentionally provoked movements in forward and backward directions. A total of 14 healthy older adults (OA) (73.14±4.26 years) and 15 healthy young adults (YA) (24.93±1.49 years) were assessed for group differences in sway behavior. Body sway speed in 22 different conditions with and without VR environments was analyzed. Significant differences and large effect sizes were observed in AP sway under the VR environments (OA with P < 0.02; effect size> 0.61, YA with P < 0.003; effect size> 0.72) compared to the baseline condition without the VR environments. In addition, significant differences were found between the two groups in AP sway in all test conditions (P < 0.01). Our study shows that a VR environment can trigger body sway in an expected direction, which may indicate that it is possible to enhance the sensitivity of balance assessment by integrating immersive VR environments. The result of this study warrants a cross-sectional study in which OA diagnosed with and without dementia are compared on their sway behavior.

Ambulatory urodynamic monitoring assessment of dorsal genital nerve stimulation for suppression of involuntary detrusor contractions following spinal cord injury: a pilot study.

STUDY DESIGN: A prospective interventional pilot study using within-individual comparisons. OBJECTIVES: To assess the effect of dorsal genital nerve stimulation (DGNS) on urine-storage parameters in participants with spinal cord injury (SCI) and neurogenic detrusor overactivity (NDO) during natural bladder filling. SETTING: The London Spinal Cord Injuries Centre at the Royal National Orthopaedic Hospital, Stanmore, UK. METHODS: Ambulatory urodynamic monitoring (AUM) was carried out with and without DGNS, before and after a week of using DGNS at home. DGNS was applied on-demand by four participants with bladder sensation, and both continuously and intermittently by one participant with absent sensation. A Wilcoxon sign-rank test was used to test paired results of changes within an AUM session. RESULTS: Urodynamic outcomes were improved using DGNS. Bladder capacity was increased from 244 ± 59 to 346 ± 61 ml (p = 0.0078), a mean change of 46 ± 25%. Maximum detrusor pressure was decreased from 58 ± 18 to 47 ± 18 cmH2O (p = 0.0156), a change of 17 ± 13%, and average peak detrusor pressure was decreased from 56 ± 16 to 31 ± 128 cmH2O (p = 0.0156), a mean reduction of 50 ± 19%. There was an increase in the number of detrusor contractions from the first involuntary detrusor contraction to a strong desire, urgency or incontinence, from 1.5 ± 1.4 to 4.3 ± 1.7, and an increase in time of 23 ± 22 min. There were no changes in baseline outcomes following home use of DGNS. CONCLUSIONS: DGNS may be applied on-demand, intermittently or continuously, to increase bladder capacity, decrease storage pressures and provide extra time. Improvements were made in addition to existing antimuscarinic medication regimes.