A structural analysis of the rail unit of an indoor assistive mobility system.

BACKGROUND: Individuals with gait disturbances, such as that post-stroke, are discharged home to undergo outpatient rehabilitation. Rehabilitation in the community is not as effective as that in hospital, due to long travel times and short program duration. OBJECTIVE: This study analyzed rail unit structure, with the aim of assisting home indoor assistive mobility system (HIAMS) development, allowing patients to undergo gait-related rehabilitation training at home. METHODS: The HIAMS consists of a mobile rail running around the whole room, a turn-table for movement between rails, and a weight-supporting component. Structural analysis was performed using the Abaqus/CAE solution (Version 6.14, Dassault systems, Inc.) to verify device safety, according to the load applied to the rail and turn-table units. The load was applied vertically at 150 kg to reflect the weight of potential users. RESULTS: Structural analysis was performed on the weight-supporting components, which was consist of turn-table case, bearing components (center, left), connective bracket and rail rollers. The safety factors of each components were estimated as 1.31, 5.39 (bearing, center), 8.45 (bearing, left), 1.43 and 3.61 in sequence. CONCLUSION: We demonstrated a safety factor of ⩾ 1.3 for the key system units, suggesting this technology is safe for use in the home rehabilitation training of individuals with gait impairment post-ICU stay.

Loop-tail stents fail in reducing stent-related symptoms: results of a prospective randomised controlled trial.

OBJECTIVE: To compare stent-related symptoms (SRS) of loop-tail (LT) and conventional double J (DJ) stents after uncomplicated flexible ureterorenoscopy (fURS), in a prospective randomised controlled single-blind parallel-group study. PATIENTS AND METHODS: Patients undergoing fURS were randomised into two groups: the LT Group received LT stents (Polaris™ Loop) and the DJ Group received conventional DJ stents (Vortek® ). The stent was removed after 4 weeks. The Ureteric Stent Symptom Questionnaire (USSQ) was administered at 2 days, 4 and 8 weeks (baseline evaluation) after stent insertion. The primary endpoint was to compare the Urinary Symptom Index Score of the LT vs DJ groups at 4 weeks after stent insertion. The secondary endpoints were to compare the USSQ domains' subscores at 2 days and 4 weeks after stent insertion, USSQ single answers at 4 weeks, and the 4-week USSQ domains' subscores adjusted for baseline. RESULTS: A total of 68 patients were randomised (34 LT and 34 DJ). The answers given at 4 weeks were not significantly different between the two groups for the Urinary Symptom Index Score (P = 0.982), Pain Index Score (P = 0.169), visual analogue scale (P = 0.276), and all the other domains of the USSQ. At 4 weeks, the single-answer analysis did not find any differences between the groups; the urinary symptoms were all comparable, as was the requirement for pain painkillers (P = 0.684) and pain during sex (P = 0.496). There were also no significant differences for every single domain score for the responses given at 2 days. The same applied to USSQ subscores at 4 weeks adjusted for the 8-week baseline results, which were also comparable. CONCLUSIONS: The study found no differences in terms of SRS between the LT and DJ groups, either at 2 days or 4 weeks after stent insertion, with or without baseline correction.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Breast Textured Implants Determine Early T-helper Impairment: BIAL2.20 Study.

BACKGROUND/AIM: Surgical stress has been correlated with higher rate of postoperative complications. Breast implants' surfaces (textured or smooth) represent an immunological stimulus. Our prospective study (BIAL2.20) evaluated post-operative leukocytes response at baseline and postoperative day (POD) 1 and 2 after implant-based breast reconstruction. PATIENTS AND METHODS: Between January and July 2020, 41 patients underwent reconstruction with textured (n=23) or smooth (n=18) implants. A full blood count and lymphocyte subsets were collected before surgery, on POD1 and POD2. Data were evaluated as difference and relative difference from baseline by two-way analysis of variance test (2-way-ANOVA). Mann-Whitney U-test was performed at each POD, whenever between-group 2-way-ANOVA reached statistical significance. RESULTS: Within-group-analysis showed statistically significant total leukocytosis in both groups. Within-group-analysis of lymphocytes subsets demonstrated statistically significant lymphopenia in the textured group for T-lymphocytes, and T-helper cells. Between-group-analysis showed statistically significant lymphopenia in T-helper subsets in the textured group at POD1 and POD2, when compared with the smooth group. CONCLUSION: Textured implants demonstrated a statistically significant impairment of T-helper trend during POD1 and POD2 when compared to smooth implants by between-group 2-way-ANOVA.

Physical performance and perception of foot discomfort during a soccer-specific match simulation. A comparison of football boots.

Football boots are marketed with emphasis on a single key performance characteristic (e.g. speed). Little is known on how design parameters impact players' performance. This study investigated the impact of boot design on performance maintenance and perceived foot comfort during a 90-minute match simulation drill. Eleven male university football players tested two commercially available "sprint boots" known to generate significantly different plantar pressures (high=Boot H and low=Boot L) . Players completed a modified Soccer-specific Aerobic Field Test on a 3G pitch. Heart rate, rated perceived exertion and perceived foot discomfort were assessed for each 15-min interval. Power generation was assessed pre- and post-match simulation. A significantly higher mean heart rate was seen for Boot L in the 60th-75th and 75th-90th minute intervals (P = 0.017, P = 0.012 respectively). Perceived exertion did not differ between boots (P ≥ 0.302). Power generation significantly decreased in Boot H between pre- and post-match (P = 0.042). Both boots increased discomfort with significantly more plantar discomfort felt in the last 30 min in Boot H (75th min: P = 0.037; 90th min: P = 0.048). The results imply that a comfortable boot design may improve maintenance of performance during match-play.

Safety code blue! Assessing the use of blue surgical sterilization wrap for homemade respirator masks during the COVID-19 crisis.

The use of surgical sterilization wrap for respirator masks during the COVID-19 crisis has become a popularized personal protective equipment alternative option due to claims supporting its ability to meet N95 standards. This study sought to assess these claims using standardized filter testing. The tested material failed to meet N95 standards and suggests its use may place medical personnel at increased risk of harm when managing COVID-19 patients.

Duodenoscope as a Vector for Transmission.

Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.

Novel Algorithms for Reprocessing, Drying and Storing Endoscopes.

After outbreaks of duodenoscope-transmitted infection with multidrug-resistant organisms, it has become clear that institutions must optimize their endoscope reprocessing programs. Standard endoscope reprocessing practices may not represent the ideal approach for preventing transmission of infection related to endoscopy. We discuss multiple approaches to enhance and optimize reprocessing, drying, and storage of standard duodenoscopes. The optimal enhanced duodenoscope reprocessing modality remains to be determined. Acknowledging the challenges and limitations in effectively reprocessing duodenoscopes, the FDA issued a safety communiqué recommending transitioning to either single use disposable duodenoscopes or duodenoscopes with innovative designs that allow more effective reprocessing.

Recent Actions by the US Food and Drug Administration: Reducing the Risk of Infection from Reprocessed Duodenoscopes.

In addition to technological advancements, engagement and collaboration among the wider community of stakeholders will be beneficial toward reducing the risk of infection from reprocessed duodenoscopes. Such a community can raise awareness of the importance of duodenoscope cleaning, work to improve reprocessing training, identify the most pressing unanswered questions that merit further research, and develop tools that can be used by health care facilities to improve the quality of reprocessing at their sites. The Food and Drug Administration looks forward to working with the community to further reduce the risk of infections from reprocessed duodenoscopes.

Increasing evacuation flow through school bus emergency roof hatches.

Emergency escape roof hatches are used to evacuate school buses in rolled-over orientations. In the United States, the minimum opening size of a roof hatch is defined by Federal Motor Vehicle Safety Standard (FMVSS) no. 217. With the prevalence of rising obesity rates among children, the minimum roof hatch opening size may not be large enough to accommodate larger passengers. Post-accident conditions such as injuries, disorientation, and exit obstructions may also prevent unobstructed passage for egress within acceptable time limits. The purpose of this study was to redesign and fabricate a roof hatch with a larger opening and evaluate its egress characteristics for a range of typical school bus passengers. The larger roof hatch opening allows greater evacuation flow rates, and is almost functionally equivalent to the evacuation flow rate of the front door on an upright school bus.

Neuromuscular fatigue profiles depends on seat feature during long duration driving on a static simulator.

Prolonged driving could induce neuromuscular fatigue and discomfort since drivers have little opportunity to adjust their position. However, better car seat design could play a major role in limiting these effects. This study compared the effect of two different seats (S - soft and F - firm) on neuromuscular fatigue and driver's perceived discomfort during prolonged driving, also assessing the effect of different road types on neuromuscular activity. Twenty participants performed two 3-h driving sessions, one for each seat, on a static simulator. Every 20 min, participants self-evaluated their level of whole-body and individual body-area discomfort. Surface electromyography (sEMG) was recorded for eight muscles including Trapezius descendens (TD), Erector spinae longissimus (ESL), Multifidus (MF), Vastus lateralis (VL) and Tibialis anterior (TA) throughout the driving sessions. Moreover, an endurance static test (EST) was performed prior to and after each driving session. Whole-body discomfort increased with time with both seats, but no difference in discomfort scores was observed between seats throughout the driving sessions. The highest discomfort scores were for neck and lower back areas with both seats. Neuromuscular fatigue was revealed by a shorter endurance time in post-driving EST for both seats. EMG recordings showed different neuromuscular fatigue profiles for the two seats, with earlier onset of fatigue for S. Despite the lack of difference in perceived discomfort level, the two seats have different impacts: the softness of S induces greater activity of the lower back muscles, while F offers greater support for the lower back.

Negotiating stairs with an inconsistent riser: Implications for stepping safety.

Stairs are associated with falls, especially when step dimensions are inconsistent. However, the mechanisms by which inconsistencies cause this higher risk are mostly theoretical. In this experimental study we quantified the effect of inconsistent rise heights on biomechanical measurements of stepping safety from younger (n = 26) and older adults (n = 33). In ascent, both groups decreased foot clearance (~9 mm) over the inconsistently higher step (F(1,56) = 48.4, p < 0.001). In descent, they reduced foot contact length on the higher step by 3% (F(1,56) = 9.1, p < 0.01). Reduced clearance may result in a toe-catch potentially leading to a trip, while reduced foot contact lengths increase the risk of overstepping which may also lead to a fall. These effects occurred because participants did not alter their foot trajectories, indicating they either did not detect or were not able to adjust to the inconsistent rise, increasing the likelihood of a fall. Consistent stair construction is vital, and existing inconsistencies should be identified and safety interventions developed.

Unexpected Obstruction of a Parker Flex-Tip Endotracheal Tube Caused by Outward Bending of Its Tip: A Case Report.

We report a case of Parker Flex-Tip endotracheal tube obstruction caused by its tip bending outward against the tube lumen. The Parker Flex-Tip tube tip is designed to bend inward to prevent damage to airway structures during intubation. However, when its tip is bent outward, the tube aperture is distorted, shifts against the tracheal wall, and is occluded. Moreover, the cross-sectional area of the openings on the side of the endotracheal tube, the "Murphy's eyes" which are ellipses, decrease because the openings are pulled parallel to their long axis. Outward bending of the tip can obstruct the tube.

Impact of peritoneal catheter intramural design on dialysis discontinuation rate.

AIM: Catheter dislocation is an important cause of technique failure for peritoneal dialysis (PD). Aim of this study is to evaluate the effect of intramural trait configuration on this outcome. METHODS: We considered 240 swan neck, double-cuffed catheters positioned in adult patients in our Centre with mini-laparotomy technique partitioned, according with the intramural segment design, in a standard technique group (ST) (n. 199): oblique passage of the catheter through the rectus sheath in the craniocaudal direction, and in a modified technique group (MT) (n. 41): anterior fascia lanced 3 cm cranially to the deep cuff to let catheter out. The primary end-point was dialysis failure due to tip migration. Secondary end-points were any other causes of catheter removal. RESULTS: Incidence of catheter removal for non-responsive tip migration was 14.3% in MT and 6.1% in ST. Neither this difference nor the catheter survival rate for this outcome was statistically significant. PD interruption for refractory exit site/tunnel infection (ESI) was in favour of ST (4% ST, 35.7% MT; P < .01) whereas ESI catheter survival rate was only marginally significant (292.8 days in MT vs 743.6 in ST, P = .045). No other recorded cause of PD discontinuation was significantly different. CONCLUSION: Modified technique group is associated with a major ESI risk but, given the average survival, it seems to be due more to exit site management than to the specific surgical procedure. MT is not superior to ST to prevent catheter dislocation nevertheless, considering its simplicity and rapidity it can be deemed as first-choice option.

Circumferential tissue compression at the lower limb during walking, and its effect on discomfort, pain and tissue oxygenation: Application to soft exoskeleton design.

Soft exoskeletons apply compressive forces at the limbs via connection cuffs to actuate movement or stabilise joints. To avoid excessive mechanical loading, the interface with the wearer's body needs to be carefully designed. The purpose of this study was to establish the magnitude of circumferential compression at the lower limb during walking that causes discomfort/pain. It was hypothesized that the thresholds differ from those during standing. A cohort of 21 healthy participants were tested using two sizes of pneumatic cuffs, inflated at the thigh and calf in a tonic or phasic manner. The results showed lower inflation pressures triggering discomfort/pain at the thigh, with tonic compression, and wider pneumatic cuffs. The thresholds were lower during walking than standing still. Deep tissue oxygenation increased during phasic compression and decreased during tonic compression. According to the findings, circumferential compression by soft exoskeletons is preferably applied at anatomical sites with smaller volumes of soft tissue, using narrow connection cuffs and inflation pressures below 14 kPa.

Thermal comfort and virtual reality headsets.

This study proposed to investigate the thermal properties and subjective thermal discomfort of five virtual reality headsets, and their relationships. Twenty-seven university students used each of the five headsets for 45 min. Microclimate temperature and relative humidity were measured by miniature dataloggers. Infrared thermography was used to measure temperature distribution on the contact points between user's face and the headsets. Participants reported subjective thermal discomfort associated with using each headset. The average microclimate temperature and relative humidity increased by 7.8 °C and 3.5% respectively after headset use. Overall subjective thermal discomfort increased along with duration of use and came primarily from the display. Applying the linear mixed-effects model showed that subjective thermal discomfort is positively correlated with duration of use, microclimate temperature, relative humidity and display coverage area. Conversely, thermal discomfort is negatively correlated with total coverage area, with microclimate temperature acting as the most significant contributing factor. The headsets were ranked by pairing the objective measurements with subjective evaluations.

Characterizing the comfort limits of forces applied to the shoulders, thigh and shank to inform exosuit design.

Recent literature emphasizes the importance of comfort in the design of exosuits and other assistive devices that physically augment humans; however, there is little quantitative data to aid designers in determining what level of force makes users uncomfortable. To help close this knowledge gap, we characterized human comfort limits when applying forces to the shoulders, thigh and shank. Our objectives were: (i) characterize the comfort limits for multiple healthy participants, (ii) characterize comfort limits across days, and (iii) determine if comfort limits change when forces are applied at higher vs. lower rates. We performed an experiment (N = 10) to quantify maximum tolerable force pulling down on the shoulders, and axially along the thigh and shank; we termed this force the comfort limit. We applied a series of forces of increasing magnitude, using a robotic actuator, to soft sleeves around their thigh and shank, and to a harness on their shoulders. Participants were instructed to press an off-switch, immediately removing the force, when they felt uncomfortable such that they did not want to feel a higher level of force. On average, participants exhibited comfort limits of ~0.9-1.3 times body weight on each segment: 621±245 N (shoulders), 867±296 N (thigh), 702±220 N (shank), which were above force levels applied by exosuits in prior literature. However, individual participant comfort limits varied greatly (~250-1200 N). Average comfort limits increased over multiple days (p<3e-5), as users habituated, from ~550-700 N on the first day to ~650-950 N on the fourth. Specifically, comfort limits increased 20%, 35% and 22% for the shoulders, thigh and shank, respectively. Finally, participants generally tolerated higher force when it was applied more rapidly. These results provide initial benchmarks for exosuit designers and end-users, and pave the way for exploring comfort limits over larger time scales, within larger samples and in different populations.

Percutaneous Coronary Intervention Techniques for Bifurcation Disease: Network Meta-analysis Reveals Superiority of Double-Kissing Crush.

BACKGROUND: Provisional T-stenting (PS) is generally recommended to treat patients with coronary bifurcation disease (CBD) percutaneously, but PS may not fit all complex bifurcation anatomies. Therefore, several types of up-front 2-stent techniques have been described. We aimed to identify the best percutaneous coronary intervention (PCI) technique to manage patients with CBD. METHODS: We systematically reviewed randomized controlled trials (RCTs) including patients undergoing CBD PCI which included several types of PCI techniques-PS, double-kissing (DK) crush, T-stenting and protrusion, culotte, dedicated bifurcation stents, crushing, and T-stenting-and we compared device-oriented clinical events (DOCEs), a composite of cardiac death, target-vessel myocardial infarction, stent thrombosis, and target-lesion or target-vessel revascularization, in a network meta-analysis. We included 26 RCTs, leading to a pooled population of 10,339 patient-years and a total of 1229 DOCEs. RESULTS: The DK-crush technique was associated with the lowest DOCE rate, with a relative risk of 0.62 (95% CI 0.42-0.92) compared with the PS technique. DK-crush had the highest probability (model likelihood 90.2%, area under the cumulative ranking curve 98.0%) of being the best technique among those explored to reduce DOCEs in patients receiving CBD PCI. CONCLUSIONS: When a 2-stent strategy is considered in a patient with CBD, the DK-crush technique reduces DOCEs compared with other bifurcation techniques based on all available RCTs.

Flexible versus rigid laryngoscopy: A randomized crossover study comparing patient experience.

OBJECTIVES: To compare flexible distal-chip laryngoscopy (FDL) versus rigid telescopic laryngoscopy (RTL) in regard to examinees' pain level, comfort, satisfaction, and preference, and to evaluate the clinician's assessment of the examinees' experience with both exam types. STUDY DESIGN: Randomized crossover study. METHODS: Twenty-three normal adult subjects were recruited to undergo both FDL and RTL; the initial exam type was randomized. Subjects and clinicians completed corresponding questionnaires after each exam. Differences in participant characteristics and questionnaire scores between the two exam types were assessed via Pearson χ2 and paired t tests, respectively. RESULTS: Overall, participants reported that FDL was more uncomfortable than RTL (4.22 vs. 2.91, P = .003) and scored higher on the pain scale for FDL compared to RTL (2.91 vs. 1.70, P = .006). However, there was no significant difference in number of participants who preferred FDL versus RTL (10 [43%] vs. 13 [57%]). Poor correlation was seen between clinicians' assessment of participants' discomfort and actual reported discomfort for FDL (2.70 vs. 4.22, P = .001). CONCLUSIONS: Subjects undergoing FDL experience greater discomfort and pain compared to RTL, but do not demonstrate a differential preference of exam. Overall, clinicians underestimate the discomfort of patients undergoing FDL, but participants maintain high satisfaction with both exams nonetheless. LEVEL OF EVIDENCE: 1 Laryngoscope, 130:2663-2666, 2020.

Is it possible to constantly and accurately monitor blood sugar levels, in people with Type 1 diabetes, with a discrete device (non-invasive or invasive)?

Real-time continuous glucose monitors using subcutaneous needle-type sensors continue to develop. The limitations of currently available systems, however, include time lag behind changes in blood glucose, the invasive nature of such systems, and in some cases, their accuracy. Non-invasive techniques have been developed, but, to date, no commercial device has been successful. A key research priority for people with Type 1 diabetes identified by the James Lind Alliance was to identify ways of monitoring blood glucose constantly and accurately using a discrete device, invasive or non-invasive. Integration of such a sensor is important in the development of a closed-loop system and the technology must be rapid, selective and acceptable for continuous use by individuals. The present review provides an update on existing continuous glucose-sensing technologies, and an overview of emergent techniques, including their accuracy and limitations.